OUR NEW PROFILE IS:  (NASDAQ: COEP)

COEPTIS THERAPEUTICS SIGNS AGREEMENT TO ACQUIRE ALLOGENEIC IMMUNO-ONCOLOGY NK PLATFORM IN PHASE 1 CLINICAL TRIALS FROM DEVERRA THERAPEUTICS

COEPTIS THERAPEUTICS SECURES EXCLUSIVE RIGHTS TO NEGOTIATE TO ACQUIRE TRANSFORMATIONAL CELL THERAPY PLATFORM TO ENABLE POTENT COMBINATORIAL IMMUNO-ONCOLOGY TREATMENT STRATEGIES

COEPTIS THERAPEUTICS ENTERS INTO EXCLUSIVE OPTION AGREEMENT WITH UNIVERSITY OF PITTSBURGH FOR RIGHTS TO CAR-T TECHNOLOGIES DESIGNED TO TARGET MULTIPLE CANCER INDICATIONS, INCLUDING HEMATOLOGIC AND SOLID TUMORS

More from this week's announcement – SNAP-CAR platform provides a powerful adaptor strategy for fully programmable targeting of engineered cells to multiple antigens. Check out the peer-reviewed article in @NatureComms #SNAPCAR #CART $COEP https://t.co/26GimvOATH

— COEPTIS (@coeptistx) May 12, 2023

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Hello Everyone,

We have another profile that we want to put on your radar for tomorrow’s session.

We have had some recent success profiling small cap biotechs in recent months.

This is a company that has seen activity pick up pretty significantly over the past 3 sessions with no recent news to speak of.

Pull up COEP immediately.

This one almost doubled from late April to mid May on fairly light interest.

Coeptis Therapeutics Holdings, Inc., together with its subsidiaries including Coeptis Therapeutics, Inc. and Coeptis Pharmaceuticals, Inc., (collectively “Coeptis”), is a biopharmaceutical company developing innovative cell therapy platforms for cancer that have the potential to disrupt conventional treatment paradigms and improve patient outcomes. Coeptis’ product portfolio and rights are highlighted by a universal, multi-antigen CAR T technology licensed from the University of Pittsburgh(SNAP-CAR), and the GEAR™ cell therapy and companion diagnostic platforms, which Coeptis is developing with VyGen-Bio and leading medical researchers at the Karolinska Institutet. Coeptis’ business model is designed around maximizing the value of its current product portfolio and rights through in-license agreements, out-license agreements and co-development relationships, as well as entering into strategic partnerships to expand its product rights and offerings, specifically those targeting cancer. The Company is headquartered in Wexford, PA.

MAJOR CATALYSTS

👉Potential acquisition of VyGen-Bio would strengthen their oncology pipeline by obtaining exclusive, worldwide ownership rights to GEAR™ Platform

👉Focused on SNAP-CAR T Cells, a Platform Technology Being Developed to be Combined with Tagged, Tumor-Specific Antibodies to Potentially Target Many Different Tumor      Types.

👉Exclusive Rights to Acquire Transformational Cell Therapy Platform to Enable Potent Combinatorial Immuno-Oncology Treatment Strategies.

👉SNAP-CAR Technology Highlighted in Peer-Reviewed Article in Translational Medicine Journal.

👉Research Agreement with the University of Pittsburgh to Expand Pre-Clinical Development of SNAP-CAR T Cells Targeting HER2-Positive Cancers.

👉Collaboration with IQVIA, a Global Contract Research Organization, to Identify Target Indications and Initiate IND-Enabling Activities.

👉CAR T Cell Therapy Market is Expected to Reach $20.56 Billion by 2029 from $1.96 Billion in 2021.

Coeptis Therapeutics, Inc. has entered into an exclusive license agreement with the University of Pittsburgh for certain intellectual property rights to technologies developed within research laboratories at the University of Pittsburgh. Chimeric antigen receptors (CARs) are artificial T cell receptors that re-target T cells to specifically recognize and kill tumor cells. The licensing agreement involves a CAR T cell therapy platform called “SNAP CAR” designed to be a universal therapeutic in the treatment of various types of cancer. The SNAP-CAR T cell therapy is currently in preclinical development.

Through the company’s subsidiary, Coeptis Pharmaceuticals, they have entered into co-development agreements with VyGen-Bio, led by its team of leading medical researchers at the Karolinska Institutet (KI) based in Stockholm, Sweden, to jointly develop novel natural killer cell-based therapeutics and related diagnostics with an initial focus on the urgent need to improve treatments for cancers that over-express the CD38 protein (CD38+).

COEP‘s Scientific Collaboration

Coeptis is collaborating with researchers from the University of Pittsburgh and contracted a prominent Clinical Research Organization (CRO) to begin developing the SNAP-CAR T cell therapy with the goal to pursue clinical trials. Coeptis has been assigned the worldwide development and commercialization rights to the licensed technology in the field of human treatment of cancer with antibody or antibody fragments using SNAP-CAR T cell technology.

VyGen-Bio is a discovery-stage, cell-based immunotherapy company focused on the development of transformational technology platforms: GEAR-NK, modified natural killer cell-based therapeutics (NK cells), optimized to be co-administered with targeted antibodies; and, GEAR Diagnostic, a companion diagnostic being developed to select patient populations most likely to benefit from targeted antibody therapies.

CAR T And SNAP-CAR Strategy

The Importance Of CAR T Cell Therapy – Chimeric antigen receptor (CAR) therapy is a new treatment for cancer in which a patient’s T cells (a type of immune cell) are genetically engineered to recognize cancer cells to target and destroy them. Cells are extracted from the patient and then genetically engineered to make the CAR and are re-introduced back into the patient. Currently approved CAR T therapies are revolutionizing the treatment of many blood cancers including B cell leukemias and lymphomas by targeting specific proteins found on these cancers, and there is hope in treating additional cancers including solid tumors by having them recognize new targets.

What is SNAP-CAR And How Does It Target Certain Cancers? – Coeptis has licensed a CAR T cell therapy platform called “SNAP-CAR” to be a universal therapeutic. The SNAP-CAR technology is in preclinical development at the University of Pittsburgh. Instead of directly binding to a target on the tumor cell, the CAR T cells are co-administered with one or more antibody adaptors that bind to the tumor cells and are fitted with a chemical group that irreversibly connects them to the SNAP-CAR on the therapeutic cells via a covalent bond. A covalent bond is the highest affinity bond possible, thus this binding is expected to translate to highly potent therapeutic activity.

SNAP-CAR, A Highly Programmable Therapeutic Platform –Pre-clinical studies in mice have demonstrated that by targeting tumors via antibody adaptor molecules, the SNAP-CAR therapy provides a highly programmable therapeutic platform that may present several potential advantages over standard CAR T treatments.

Immunotherapy Challenges

Reducing potential toxicity: The therapeutic activity of the SNAP-CAR T cells can be controlled by the antibody dose, which we envision would allow clinicians to potentially mitigate toxicity from over-activity. We also envision that the immune response against cancer may also be boosted in patients with additional doses of the tagged tumor-specific antibody.

The Goal

Lowering the chance for cancer relapse: Relapse from CAR T cell therapy which often results from the loss or down-regulation of the targeted protein on the cancer, can potentially be avoided by combining SNAP-CAR T cells with antibodies targeting multiple antigens at once.

A Novel Approach

Targeting new cancers: SNAP-CAR T cells are a platform technology that is being developed to be co-administered with tagged, tumor-specific antibodies to potentially target many different tumor types, including hematological malignancies and solid tumors.

GEAR-NK (CD38) Strategy

GEAR-NK (CD38) – The company’s science stems from the premise that certain cancer therapies for CD38+ tumors can be enhanced to minimize off-target effects while harnessing the therapeutic impact of NK cells. CD38 is a multifunctional transmembrane glycoprotein that is abnormally overexpressed in a variety of tumor types and is associated with cancer progression.

Immunotherapies, specifically anti-CD38 monoclonal antibodies (mAbs) target the CD38+ cancer cells, but also kill other important innate immune effector cells such as CD38+NK cells that recognize and destroy cancer cells, or virus-infected cells.

How Does CD38 Play An Important Role In Targeting Certain Cancers? – CD38 is a protein receptor overexpressed on certain cancers including hematological malignancies and solid tumors. With the development of anti-CD38 monoclonal antibody therapies (mAbs) designed to bind to CD38 antigen to generate immune-mediated killing, survival outcomes for CD38+ cancers have significantly improved. However, despite the potential benefit of anti-CD38 mAbs, cancers such as multiple myeloma are still considered to be incurable.

Immunotherapy Challenges

Various immunotherapies for CD38+ tumors are designed to find and kill cells that express the CD38 antigen; therefore, CD38+ NK cells are likely to become collateral damage and with their eradication, the overall anti-tumor response is suboptimal.

The Goal

To protect CD38+ Natural Killer (NK) cells so that functional disease-targeting NK cells will not be eradicated, enabling their co-existence with CD38 targeting therapies, and thus allowing for complementary tumor killing and immune surveillance.

A Novel Combinatorial Approach

Modified NK cells that are co-administered with select monoclonal antibodies and/or other CD38 targeting immunotherapies are in pre-clinical development to enhance and maximize tumor kill via combinatorial approaches otherwise not possible.

Highlighting some coverage from our announcement on Tuesday. $COEP https://t.co/3jqi8ZkXYh

— COEPTIS (@coeptistx) April 20, 2023

COEPTIS THERAPEUTICS SIGNS AGREEMENT TO ACQUIRE ALLOGENEIC IMMUNO-ONCOLOGY NK PLATFORM IN PHASE 1 CLINICAL TRIALS FROM DEVERRA THERAPEUTICS

Proposed transaction would provide Coeptis with two clinical stage assets leveraging NK cell therapies in relapsed or refractory acute myeloid leukemia (AML) and hospitalized respiratory infections, as well as preclinical programs for hematologic and solid tumors

Clinical data from AML Clinical Trial Expected during 2H 2023

WEXFORD, Pa. , April 18, 2023 /PRNewswire/ — Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) (“Coeptis” or “the Company”), a biopharmaceutical company developing innovative cell therapy platforms for cancer, announced it has entered into a binding term sheet with Deverra Therapeutics, Inc. (“Deverra Therapeutics”) pursuant to which it has obtained an exclusive right, until August 31, 2023, to negotiate towards the acquisition or license of assets from Deverra Therapeutics related to its proprietary allogeneic stem cell expansion and directed differentiation platform for the generation of multiple distinct immune effector cell types, including natural killer (NK) and monocyte/macrophages. Deverra Therapeutics is currently advancing clinical programs investigating these technologies in relapsed/refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) and patients hospitalized with respiratory viral infections.

The transaction, if finalized, would provide Coeptis with, among other assets, exclusive rights to two FDA approved Investigational New Drug (IND) applications and two Phase 1 clinical trials (NCT04901416, NCT04900454) investigating infusion of DVX201, an unmodified natural killer (NK) cell therapy generated from pooled donor CD34+ cells, in hematologic malignancies and viral infections. In addition, Coeptis would gain access to a highly scalable allogeneic cellular immunotherapy platform that is being developed to generate and deliver off-the-shelf (no HLA matching), cost effective, on demand cell therapies to a broad patient population. Deverra expects phase I clinical trial data from its AML study to be complete during 2H 2023.

Additionally, subject to the successful negotiation and completion of any proposed transaction, Deverra Therapeutics’ current Scientific Founder, Chief Scientific Officer and EVP, Research & Development, Colleen Delaney, MD, would be expected to assume the position of Chief Scientific and Medical Officer at Coeptis Therapeutics. Dr. Delaney is a world-renowned expert in cell and gene therapy research with more than 20 years’ experience in the translation of scientific discovery to clinical practice, including all aspects of cell therapy product development.

“This transaction would greatly expand Coeptis’ technology portfolio by incorporation of a cutting-edge allogeneic cell therapy platform with extensive safety and clinical data and align itself with leading experts in the field of cell and gene therapy,” said Dave Mehalick, President and CEO of Coeptis Therapeutics. Mr. Mehalick continued, “The addition of these clinical and pre-clinical immune effector cell programs would significantly diversify our R&D capabilities and bring a clinical pipeline with multiple novel approaches to combination cellular immunotherapy approaches, not yet achieved by others. Importantly, the substantial capabilities of the allogeneic cell therapy platform would open new pathways for Coeptis to consider expanding its cell-based therapies beyond autologous CAR T. We are excited about the possibility of exploring the application of both the SNAP-CAR and GEAR technologies to allogeneic, off-the-shelf immune effector cells. The NK and macrophage (MAC) immune effector cell generation from Deverra’s platform combined with Coeptis’ target specific CARs has the potential to result in development of allogeneic NK and MAC cell therapies.”

Dr. Delaney stated: “Deverra’s allogeneic cell therapy platform has been in use clinically since 2006, and we have generated significant clinical and safety data since that time. This platform has been shown to provide extreme flexibility and optionality in the generation and modification of multiple distinct immune effector cell types from a single platform. We are excited about the prospect of bringing together our established allogeneic cell platform with the novel targets and technologies from Coeptis to generate first-in-class allogeneic cell therapies to treat a wide range of life-threatening disorders in a cost effective and clinically accessible way.”

The proposed transaction is subject to confirmatory due diligence, negotiation and execution of definitive documentation based on agreed terms and other closing conditions, including third party approvals, as well as a right of first refusal in place that a third party possesses and will have a right to exercise. There can be no assurance that the parties will reach a definitive agreement related to the proposed acquisition or license of assets or that, even if any such agreement is reached, any such transaction will be successfully consummated.

About Deverra Therapeutics

Deverra Therapeutics is a privately held clinical stage biotechnology company dedicated to the development of allogeneic, off-the-shelf (no matching required) cellular immunotherapies for on-demand treatment of patients with cancer and infectious diseases. Deverra is the only company with a proprietary and clinically proven stem cell expansion technology that also serves as starting material for generation of multiple fully functional immune effector cells that can also be engineered to be potent killers of cancer cells. Deverra was a pioneer developing universal non-HLA matched allogeneic and off-the-shelf cell therapies that have been utilized in multiple clinical trials with no safety concerns.

COEPTIS THERAPEUTICS SECURES EXCLUSIVE RIGHTS TO NEGOTIATE TO ACQUIRE TRANSFORMATIONAL CELL THERAPY PLATFORM TO ENABLE POTENT COMBINATORIAL IMMUNO-ONCOLOGY TREATMENT STRATEGIES

Potential acquisition of VyGen-Bio would strengthen Coeptis’ oncology pipeline by obtaining exclusive, worldwide ownership rights to GEAR™ Platform and companion diagnostic technologies

WEXFORD, Pa., March 29, 2023 /PRNewswire/ — Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) (“Coeptis” or “the Company”), a biopharmaceutical company developing innovative cell therapy platforms for cancer, announced it has obtained the exclusive right to negotiate towards the acquisition of VyGen-Bio, Inc. or its assets. Coeptis intends to immediately commence its due diligence review of VyGen-Bio’s assets, including its IP and knowhow related to rights to GEAR™ cell therapy and companion diagnostic platforms, and, depending on the results of its due diligence analysis, turn to negotiation of definitive deal documents. VyGen-Bio’s product candidates and platforms were discovered by scientists at the world-renowned Karolinska Institutet in Stockholm, Sweden, including Dr. Arnika Wagner, who is expected to play a key collaborative development role for Coeptis as the Company builds its capabilities to develop treatments for cancer and gains technologies to develop additional cell and gene therapies.

This transaction, if finalized, would expand upon Coeptis’ collaboration with VyGen-Bio, which is currently focused on CD38-GEAR-NK, a natural killer (NK) cell therapy for the treatment of CD38+ cancers with an initial focus on multiple myeloma, and CD38-Diagnostic, an in vitro diagnostic tool being developed to help identify cancer patients who may be appropriate candidates for anti-CD38 mAb therapy.

In the event a transaction is consummated, Coeptis would then be in a position to advance the development of various GEAR-engineered cells, including NK cells, T cells, and hematopoietic stem cells, and to pursue development of GEAR-engineered cells for use in combination with mAbs that target a potentially wide range of receptor targets. Additional development options that would be explored could include therapeutic modalities where the antigen-specificity of mAbs is used, such as CAR-T and bispecific antibodies for the treatment of a broad range of hematologic malignancies and solid tumors.

“We believe that the acquisition of VyGen-Bio’s GEAR Platform would represent a significant inflection point in the growth of Coeptis and our strategy to be a leader in the development of ‘next generation’ cell therapy technologies for cancer and other diseases,” said Dave Mehalick, President and CEO of Coeptis Therapeutics. “Our vision for GEAR is bold and ambitious, as we believe this novel cell engineering approach protects the integrity, fitness and function of the cell while importantly shielding it from destruction by co-administered mAbs. We believe the GEAR platform offers the potential to not only improve existing cancer therapies, but further expand the use of existing therapies in new indications.”

“If we are able to successfully consummate an acquisition transaction, we plan to initially focus on advancing the first GEAR candidate, CD38-GEAR-NK, to the clinic for the treatment of multiple myeloma and to concurrently engage in business development activities to expand the GEAR Platform into new cell therapy products via potential co-development and/or licensing partnerships,” Mehalick added.

GEAR was discovered by scientists at the Karolinska Institutet (KI), including Evren Alici M.D., Ph.D., Hans-Gustaf Ljunggren M.D., Ph.D., and Arnika Kathleen Wagner Ph.D. Drs. Alici, Ljunggren, and Wagner are founding members of VyGen-Bio and will continue to contribute in the development of the technology platforms as members of Coeptis’ Scientific Advisory Board. Drs. Ljunggren and Alici are managing directors of NextGenNK, an international Competence Center for the development of next-generation NK cell-based cancer immunotherapies based at KI and funded by Sweden’s innovations agency, Vinnova. KI is globally recognized for its Nobel Assembly, which awards the Nobel Prize in Physiology or Medicine.

“GEAR-NK cells, and ultimately all GEAR-engineered cells, are being designed to potentially decrease side-effects associated with certain mAb therapies and potentially reduce or eliminate the ‘on-target-off-tumor’ effect. As a Coeptis’ SAB member, I look forward to collaborating in the development of these technologies, which may have widespread applicability in cancer and beyond,” stated GEAR co-inventor, Dr. Wagner.

About VyGen-Bio™, Inc.

VyGen-Bio is a discovery-stage, cell-based immunotherapy company focused on the development of potentially transformational technology platforms. GEAR-NK is a modified NK cell-based therapeutic being designed to be co-administered with targeted antibodies. The Company is also developing companion diagnostics designed to potentially identify patient populations that may be most likely to benefit from targeted antibody therapies. Headquartered in Tampa, Florida on the campus of the H. Lee Moffitt Cancer Center, VyGen-Bio is a majority-owned subsidiary of Vycellix, Inc. (www.Vycellix.com). The Company’s platforms were discovered by scientists at Karolinska Institutet (KI), Stockholm, Sweden that collaborate with VyGen-Bio. Additionally, VyGen-Bio is a Partner in “NextGenNK”, an international Competence Center for the development of next-generation NK cell-based cancer immunotherapies based at KI and funded by Sweden’s innovations agency, Vinnova. KI is globally recognized for its Nobel Assembly, which awards the Nobel Prize in Physiology or Medicine.

NEWS

• May 17, 2023Coeptis Therapeutics Appoints Brian Cogley as Chief Financial Officer15-year accounting and finance career spans several sectors including life sciences and underscores financial leadership abilities WEXFORD, Pa., May 17, 2023 /PRNewswire/ — Coeptis Therapeutics…
• May 10, 2023Coeptis Therapeutics’ SNAP-CAR Technology Platform for Programmable Antigen Targeting Featured in Peer-Reviewed Article in Nature CommunicationsSNAP-CAR represents a major advance potentially expanding the targeting capabilities of chimeric antigen receptor (CAR) T cells for various cancers and other indications WEXFORD, Pa., May 10, 2023…
• Apr 18, 2023Coeptis Therapeutics Signs Agreement to Acquire Allogeneic Immuno-Oncology NK Platform in Phase 1 Clinical Trials from Deverra TherapeuticsProposed transaction would provide Coeptis with two clinical stage assets leveraging NK cell therapies in relapsed or refractory acute myeloid leukemia (AML) and hospitalized respiratory…
• Mar 29, 2023Coeptis Therapeutics Secures Exclusive Rights to Negotiate to Acquire Transformational Cell Therapy Platform to Enable Potent Combinatorial Immuno-Oncology Treatment StrategiesPotential acquisition of VyGen-Bio would strengthen Coeptis’ oncology pipeline by obtaining exclusive, worldwide ownership rights to GEAR™ Platform and companion diagnostic technologies WEXFORD, Pa.
• Mar 21, 2023Coeptis Therapeutics’ SNAP-CAR Technology Platform Highlighted in Peer-Reviewed Article in Translational MedicineSNAP-CAR recognized in research detailing advances in modulating chimeric antigen receptor (CAR) T cell activity for improved safety, efficacy, and flexibility WEXFORD, Pa., March 21, 2023 /PRNewswire
• Feb 7, 2023Coeptis Therapeutics and ShareIntel Enter Shareholder Service Agreement, Targeting Illegal Short SellingCoeptis strengthens measures to protect shareholder interests through ShareIntel’s investigation and due diligence services WEXFORD, Pa., Feb. 7, 2023 /PRNewswire/ — Coeptis Therapeutics…
• Jan 31, 2023Coeptis Therapeutics Enters into Sponsored Research Agreement with the University of Pittsburgh to Advance SNAP-CAR Development ProgramCoeptis to collaborate with the University of Pittsburgh to expand pre-clinical development of SNAP-CAR T cells targeting HER2-positive cancers WEXFORD, Pa., Jan. 31, 2023 /PRNewswire/ — Coeptis…
• Nov 22, 2022Coeptis Therapeutics Engages IQVIA to Support SNAP-CAR Development ProgramCoeptis to collaborate with IQVIA, a global contract research organization, to identify target indications and initiate IND-enabling activities for SNAP-CAR WEXFORD, Pa., Nov. 22, 2022…
• Nov 15, 2022Coeptis Therapeutics Holdings to Ring the Nasdaq Stock Market Opening BellCoeptis Therapeutics Holdings, Inc. (NASDAQ: COEP), a biopharmaceutical company developing innovative cell therapy platforms for cancer, today announced that President, Chairman and CEO Dave…
• Nov 8, 2022Coeptis Therapeutics’ Scientific Advisory Board Members Featured on “Biology of Natural Killer (NK) Cells” PodcastCoeptis Therapeutics Holdings, Inc. (NASDAQ: COEP), a biopharmaceutical company developing innovative cell therapy platforms for cancer, today announced that two members of its Scientific Advisory…
• Nov 2, 2022Coeptis Therapeutics Holdings Expands Board of Directors with New AppointmentsNew directors join Coeptis’ Board following completion of merger with Bull Horn Holdings and advancement to Nasdaq WEXFORD, Pa., Nov. 2, 2022 /PRNewswire/ — Coeptis Therapeutics Holdings, Inc….
• Oct 31, 2022Coeptis Therapeutics, Inc. Announces Closing of Business Combination with Bull Horn Holdings Corp.Combined company to operate as Coeptis Therapeutics Holdings, Inc. and commence trading on The Nasdaq Global Market under Ticker Symbol “COEP” WEXFORD, Pa. and MIAMI, Oct. 31, 2022 /PRNewswire/ –…
• Sep 21, 2022Coeptis Therapeutics Enters Exclusive License Agreement with University of Pittsburgh for Rights to SNAP-CAR, a “Multi-Antigen” CAR T TechnologySNAP-CAR therapy provides a highly programmable therapeutic platform designed to potentially target many tumor types, including hematological malignancies and solid tumors WEXFORD, Pa., Sept. 21, 2022

MANAGEMENT

LEADERSHIP TEAM

Management has demonstrated a track record of acquiring and developing novel therapies.

DAVE MEHALICK

CHAIRMAN, PRESIDENT AND CHIEF EXECUTIVE OFFICER

Mr. Mehalick is a successful executive with a career spanning over 30 years across a variety of industries including life sciences, technology, financial services, military contracting, entertainment, and consumer products. His career has allowed him deep immersion into all facets of executive management notably mergers and acquisitions, corporate finance, C- Suite management, product development and licensing, partnerships, product commercialization, and corporate communications. Mr. Mehalick has assisted and managed several organizations towards successful investor monetization across all aspects of company evolution resulting in billions of dollars in transactions and financings. Currently, Mr. Mehalick is our Chairman, Chief Executive Officer and President, and one of our co-founders. He has been involved in several companies in a variety of positions and functions prior to Coeptis spanning many different industries. Mr. Mehalick began his career in the financial services industry in the wealth management area before transitioning to investment banking in the early 2000’s. He held positions of Vice President and Senior Vice President at multiple firms notably First Union Capital Markets, Gruntal and Co. and Ferris Baker Watts. He then began working earnestly with companies to assist them in all aspects of growth. He was a founding partner in American Defense Systems, a military contractor designing lightweight antiballistic armor and hardening systems for transportation and solid structures. After procuring several military contracts, the company grew revenues to a point that they became public on the AMEX stock exchange. Throughout his career Mr. Mehalick was involved in numerous similar situations either in a management or consultant role to allow strong returns for shareholders via acquisitions or public strategies.

BRIAN COGLEY

CHIEF FINANCIAL OFFICER

Brian Cogley is a senior-level financial executive with 15 years of experience in corporate finance and accounting across a variety of industries, including life sciences, pharmaceuticals, financial services, and manufacturing. Prior to joining Coeptis Therapeutics, Mr. Cogley was a Senior Manager in the Accounting Advisory practice at CFGI, LLC., where he served pharmaceutical and financial services clients in technical accounting implementations and execution. In this role, he led financial operations for client companies and successfully executed various financial projects while performing multiple interim management roles. Formerly, Mr. Cogley worked as the Vice President of Finance & Accounting at NexTier Bank, after holding previous roles as Global Cash Manager, Senior Accountant, Financial Analyst and Senior Audit Associate across the finance industry, including at KPMG, a “Big 4” accounting firm. In Mr. Cogley’s varied career experience, he developed expertise in financial planning, reporting and variance analysis, as well as in asset and liability management, handling cash, investments, derivatives and debt portfolios for efficient use of company funds. A forward-thinker with problem-solving skills and enthusiasm, Mr. Cogley’s leadership of teams has resulted in innovative thinking and tangible results. Mr. Cogley holds a bachelor’s degree in accounting and a Master of Business Administration with a concentration in finance from Duquesne University.

CHRISTINE SHEEHY

VP OF COMPLIANCE AND CORPORATE SECRETARY

Christine Sheehy is a pharmaceutical business leader with over 25 years of experience, including globally commercializing drug products and working in development of targeted therapeutics including cell and gene therapies. Ms. Sheehy was Senior Vice-President of Operations for Kadmon Pharmaceuticals, leading the global supply chain, distribution, and IT organizations. She was a founding employee of start-up pharmaceutical company Three Rivers Pharmaceuticals, which was acquired by Kadmon Pharmaceuticals in 2010. During that time, she launched branded and generic products in the U.S., leading the operational business. Globally, Ms. Sheehy has executed international supply and distribution partnerships in Europe and Asia. Prior to Three Rivers Pharmaceuticals, Ms. Sheehy held various roles ranging from business and finance consulting to financial management. Strategically minded, with a strong ability to understand all aspects of the business, her leadership skills have been developed by working substantially in start-ups and early-stage companies. Additionally, over the past 15 years Ms. Sheehy has held board of director and advisory positions for multiple industry organizations, and she holds a bachelor’s degree in accounting from Penn State University.­­­­

DAN YERACE

DIRECTOR AND VICE PRESIDENT OF OPERATIONS

Dan Yerace is a co-founder of Coeptis Pharmaceuticals and serves as the Vice President of Operations. Mr. Yerace has over ten years of experience in the pharmaceutical industry and is a key strategist responsible for supply chain management, business development, portfolio management, and corporate strategy. Mr. Yerace has broad operational experience and has held leadership positions in procurement, global supply chain management, operations, and business development for small private firms and fortune 500 multi-national corporations. Prior to joining Coeptis, Mr. Yerace served as Senior Director of Global Supply Chain and Commercial Business Development for Kadmon Pharmaceuticals. Mr. Yerace holds a bachelor’s degree in economics, and a masters of business administration from Waynesburg University.

Sincerely,

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OUR NEW PROFILE IS:   (NASDAQ: GNPX)

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GNPX HAS ALREADY RECEIVED FAST TRACK DESIGNATION FOR ACCLAIM 2

GENPREX RECEIVES SAFETY REVIEW COMMITTEE APPROVAL TO ADVANCE TO PHASE 2 EXPANSION PORTION OF ACCLAIM-1 CLINICAL TRIAL OF REQORSA® IN COMBINATION WITH TAGRISSO® IN ADVANCED NON-SMALL CELL LUNG CANCER 

INDEPENDENT RESEARCHERS FIND THAT TUSC2, THE GENE DELIVERED BY GENPREX’S REQORSA®, FUNCTIONS AS A NOVEL TUMOR SUPPRESSOR FOR GLIOBLASTOMA

GENPREX COLLABORATORS REPORT POSITIVE PRECLINICAL DATA WITH NPRL2 GENE THERAPY UTILIZING NON-VIRAL ONCOPREX® NANOPARTICLE DELIVERY SYSTEM IN NON-SMALL CELL LUNG CANCER AT THE 2023 AACR ANNUAL MEETING

CHECK OUT THE INVESTOR PRESENTATION HERE

Genprex Receives Safety Review Committee Approval to Advance to Phase 2 Expansion Portion of Acclaim-1 Clinical Trial of REQORSA® in Combination with Tagrisso® in Advanced Non-Small Cell Lung Cancer https://t.co/RPWO9J0gpR $GNPX

— Genprex, Inc. (@genprex) May 30, 2023

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Hello Everyone,

We have another profile for you to research for Friday’s session.

This is a company you are definitely going to want to research immediately.

Pull up GNPX right away.

This one looks like it is moving north with some steam as it has been seeing interest pick up with a close at the HOD, also making a new 30 day high.

TAKE A LOOK AT THE 10 DAY CHART.  NOTICE HOW IT RECENTLY EXPLODED OFF OF THE LOWS WHEN IT SAW SOME PROFIT TAKING AFTER A BIG MOVE AND IS MOVING NORTH.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes.

Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options.

Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches.

Genprex’s oncology program utilizes its proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans.

ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is then taken up by tumor cells that express tumor suppressor proteins that are deficient in the body.

The Company’s lead product candidate, REQORSA™ is being evaluated as a treatment for non-small cell lung cancer (NSCLC) (with each of these clinical programs receiving a Fast Track Designation from the Food and Drug Administration) and for small cell lung cancer.

Genprex’s diabetes gene therapy approach consists of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes directly to the pancreas.

In models of Type 1 diabetes, the genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system.

In Type 2 diabetes, where autoimmunity is not at play, it is believed that exhausted beta cells are also rejuvenated and replenished.

Research And Development Pipeline

CATALYSTS

– Addressing unmet medical need in large markets through the buildout of a robust pipeline of new drug candidates and drug combinations.

– Leveraging a gene therapy platform; Genprex’s non-viral ONCOPREX® Nanoparticle Delivery System is designed to deliver a variety of therapeutic genes to fight multiple types of cancer.

– REQORSATM immunogene therapy, the first systemically delivered gene therapy used for cancer in humans, can be combined with top-selling cancer drugs and may improve their benefits.

– Genprex has demonstrated clinical achievement with REQORSA in two clinical trials, showing a favorable safety profile and evidence of efficacy in lung cancer.

– GPX-002, Genprex’s diabetes gene therapy, works to transform alpha cells in the pancreas into insulin producing beta-like cells. A Phase 1 clinical trial could be the first-ever gene therapy tested in humans for diabetes.

– Advancing novel gene therapies in diseases with large markets and unmet needs.

– Two NSCLC trials currently enrolling; both with FDA Fast Track Designations.

– World class academic partners.

GENPREX RECEIVES SAFETY REVIEW COMMITTEE APPROVAL TO ADVANCE TO PHASE 2 EXPANSION PORTION OF ACCLAIM-1 CLINICAL TRIAL OF REQORSA® IN COMBINATION WITH TAGRISSO® IN ADVANCED NON-SMALL CELL LUNG CANCER 

TAKE A LOOK AT THE CHART.  NOTICE HOW IT RECENTLY EXPLODED OFF OF THE LOWS AND IS MOVING NORTH.

CLINICAL TRIALS

ONC-001

EVALUATING THE SAFETY OF REQORSA® IMMUNOGENE THERAPY AS A MONOTHERAPY (COMPLETED)

A Phase 1 dose escalation trial was conducted at The University of Texas MD Anderson Cancer Center evaluating the systemic, intravenous delivery of REQORSA® (TUSC2/FUS1) as a monotherapy in stage IV recurrent, metastatic lung cancer patients. The primary objective of this Phase 1 trial was to assess the toxicity of REQORSA administered systemically and intravenously, to determine the maximum tolerated dose, or MTD, and to determine a recommended Phase 2 dose of REQORSA alone.

THE FIRST SYSTEMICALLY DELIVERED GENE THERAPY USED FOR CANCER IN HUMANS

The study showed for the first time that a tumor suppressor gene can be delivered systemically, intravenously and selectively to a patient’s cancer cells using a systemic nanoparticle vector. Although this trial was not designed to show changes in outcomes, a halt in cancer growth was observed in a number of patients. REQORSA was well tolerated with tumor responses noted in lung primary and metastatic cancers in the liver, pancreas, and lymph nodes. In addition, pre- and post-treatment patient biopsies demonstrated that intravenous REQORSA selectively and preferentially targeted patients’ cancer cells.

Metabolic Tumor Response in a Metastatic Lung Cancer Subject

This subject survived after subsequent therapy more than seven years after the final treatment with REQORSA, to our knowledge, without evidence of cancer progression in the responding sites.

ONC-002

COMBINING REQORSA® IMMUNOGENE THERAPY WITH TARCEVA (ERLOTINIB)

PHASE 1 PORTION COMPLETED; PHASE 2 PORTION NO LONGER ENROLLING DUE TO OUR CHANGE OF FOCUS TO CONDUCT ACCLAIM-1

A Phase 1/2 clinical trial evaluated REQORSA® in combination with Tarceva® in stage IIIB/IV lung cancer patients without an activating EGFR mutation and in patients with an activating EGFR mutation whose cancer has progressed on Tarceva therapy.  Patients without the EGFR mutation represent the vast majority of lung cancer patients. However, such patients generally are not candidates for Tarceva therapy.

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In the Phase 2 trial combining REQORSA with Tarceva, subjects received REQORSA in combination with Tarceva every 21 days until the occurrence of progressive disease (PD), unacceptable toxicity, withdrawal of consent, or study treatment discontinuation for other reasons, whichever occurred first. We believe that the results from the Phase 2 trial are encouraging. Out of 10 patients, 9 had received 2 or more cycles and were therefore evaluable for response. Four patients had tumor regression. The median duration of response is three months. The disease control rate (CR+PR+SD > 8weeks) was 78%, which substantially exceeds the 7% response rate (with no CRs) and 58% disease control rate reported for the LUX-Lung 1 trial, a clinical trial of Gilotrif (afatinib) in a comparable group of patients.

TECHNOLOGY

REQORSA® IMMUNOGENE THERAPY

THE FIRST SYSTEMICALLY DELIVERED GENE THERAPY USED FOR CANCER IN HUMANS

Our lead product candidate, REQORSA®  immunogene therapy (quaratusugene ozeplasmid) for non-small cell lung cancer (NSCLC), uses the company’s unique, proprietary ONCOPREX® Nanoparticle Delivery System, which we believe is the first systemic gene therapy delivery platform used for cancer in humans. In 2020, the FDA granted Fast Track Designation for REQORSA in combination with AstraZeneca’s Tagrisso® (osimertinib) in late-stage NSCLC patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. In 2021, the FDA granted Fast Track Designation for REQORSA in combination with Merck & Co’s Keytruda® (pembrolizumab) in late-stage NSCLC patients whose disease progressed after treatment with Keytruda.

The active ingredient in our lead product candidate, REQORSA, is the TUSC2 gene, a tumor suppressor gene.

REQORSA consists of the TUSC2 gene encapsulated in a nanoparticle made from lipid molecules with a positive electrical charge. REQORSA is injected intravenously and can specifically target cancer cells, which generally have a negative electrical charge. Once REQORSA is taken up into a cancer cell, the TUSC2 gene is expressed into a protein that is capable of restoring certain defective functions arising in the cancer cell. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance.

We believe that REQORSA, unlike other gene therapies, which either need to be delivered directly into tumors or require cells to be removed from the body, re-engineered and then reinserted into the body, is the first systemic gene therapy used for cancer in humans.

OVERCOMING DRUG RESISTANCE

REQORSA is a pan-kinase inhibitor shown to simultaneously inhibit the EGFR and AKT oncogenic kinase pathways in vitro and in vivo. Once the cancer cell takes up the nanoparticle containing TUSC2, it is reprogrammed to die. Resistance to targeted drugs and checkpoint inhibitors develop through activation of alternate bypass pathways. For example, when PD-1 is blocked, the TIM-3 checkpoint is up-regulated. We believe that REQORSA’s multimodal activity will block emerging bypass pathways, reducing the probability that drug resistance develops.

To learn more about scientific evidence and studies supporting REQORSA and the TUSC2 gene, please refer to our Clinical Trials and TUSC2 Bibliographypages.

GPX-002

DIABETES GENE THERAPY

GPX-002, a gene therapy for diabetes, is the most recent addition of our licensed technologies. GPX-002 was developed by researchers at the University of Pittsburgh. Diabetic mice studies have shown that GPX-002 restored normal blood glucose levels for an extended period of time, which could translate to decades in humans. This gene therapy could not only become a new treatment option for millions of diabetes patients who need insulin replacement therapy, but it holds the potential to provide long-term effectiveness, or may even be a cure, for diabetic patients.

The diabetes gene therapy, GPX-002, is comprised of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes to the pancreas. The genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system.

Diabetic mice studies show that the gene therapy restored normal blood glucose levels for an extended period of time, typically around four months. The duration of restored blood glucose levels in mice could translate to decades in humans.

The diabetes gene therapy was developed by Dr. George Gittes, a researcher at the Rangos Research Center at UPMC Children’s Hospital of Pittsburgh, where preclinical research is ongoing. GPX-002 has been tested in vivo in mice and nonhuman primates. Once sufficient preclinical data has been generated, we expect to begin a Phase I clinical trial in diabetic patients, which could be the first-ever gene therapy tested in humans for diabetes.

To learn more about scientific evidence and studies supporting GPX-002 and the Pdx1/MafA genes, please refer to our Clinical Trials and Pdx1/MafA Bibliography pages.

ONCOPREX® NANOPARTICLE DELIVERY SYSTEM

THE FIRST SYSTEMIC GENE THERAPY DELIVERY PLATFORM USED IN HUMANS FOR CANCER

Our oncology drug development program utilizes our unique, proprietary non-viral ONCOPREX Nanoparticle Delivery System, which we believe is the first systemic gene therapy delivery platform used for cancer in humans. This platform, originally developed through collaborative research between the University of Texas MD Anderson Cancer Center and the National Institutes of Health, has been optimized to work with our initial product candidate, REQORSA® immunogene therapy.

DESIGNED TO DELIVER CANCER-FIGHTING GENES SYSTEMICALLY

The ONCOPREX platform has been designed and optimized to deliver cancer-fighting genes into the patient’s body systemically. Using this system, we encapsulate plasmids that express tumor suppressor genes within lipid nanoparticles and intravenously administer the encapsulated plasmids which are taken up by the tumor cells, after which the tumor suppressor genes express proteins that are missing or found in low quantities in the tumor cells. Our nanoparticles are non-immunogenic, allowing repetitive therapeutic dosing and have been clinically shown to deliver molecular kinase inhibitors effectively.

OPTIMIZED PARTICLE SIZE

Our systemic, nanoparticle, non-viral delivery system, which is being used in our clinical trials for the treatment of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), is designed to be small enough to cross tight barriers in the lungs but large enough to avoid accumulation in the liver, spleen and kidney. The nanoparticles have been shown to be taken up by tumor cells after REQORSA administration at up to 33 times the rate they are taken up by normal cells. The cationic charge of the lipid nanoparticles targets cancer cells, which facilitates endocytosis. Once inside the cancer cell, the TUSC2 gene activates signaling pathways that result in cell destruction or apoptosis.

ENHANCED SAFETY AND EFFICACY DESIGN

We have administered REQORSA to more than 50 patients in Phase 1 and 2 clinical trials using our systemic, proprietary, non-viral delivery system.

A Phase 1 clinical trial showed that systemic, intravenous therapy using the ONCOPREX Nanoparticle Delivery System was shown to selectively and preferentially target primary and metastatic tumor cells, resulting in clinically significant anticancer activity. The nanoparticles are non-immunogenic, allowing repetitive therapeutic dosing and providing extended half-life in the circulation.

Our earlier clinical trials have also shown that the ONCOPREX Nanoparticle Delivery System is well tolerated in humans and can safely deliver high therapeutic doses. We believe the ONC-001 clinical trial was the first systemic gene therapy clinical trial using a nanoparticle delivery system to deliver a tumor suppressor gene.

Genprex’s Diabetes Gene Therapy Program: A Major Step Forward in the Fight Against Type 1 Diabetes https://t.co/j1bZ1dlzZ1 $GNPX

— Genprex, Inc. (@genprex) March 16, 2023

GENPREX COLLABORATORS REPORT POSITIVE PRECLINICAL DATA WITH NPRL2 GENE THERAPY UTILIZING NON-VIRAL ONCOPREX® NANOPARTICLE DELIVERY SYSTEM IN NON-SMALL CELL LUNG CANCER AT THE 2023 AACR ANNUAL MEETING

APRIL 19, 2023

NPRL2 Gene Therapy Induces Effective Anti-Tumor Activity in Non-Small Cell Lung Cancer Pembrolizumab Resistant Tumors in a Humanized Mouse Model

Provides Preclinical Validation of the ONCOPREX® Nanoparticle Delivery System with a Second Tumor Suppressor Gene

AUSTIN, Texas — (April 19, 2023) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its research collaborators presented positive preclinical data for the NPRL2 gene (also known as the TUSC4 gene). The studies used the Company’s non-viral ONCOPREX® Nanoparticle Delivery System in KRAS/STK11 mutant anti-PD1 resistant metastatic human non-small cell lung cancer (NSCLC) humanized mouse models and were presented at the 2023 American Association of Cancer Research (AACR) annual meeting, which took place from April 14-18, 2023 in Orlando, Florida.

“We are pleased to have these positive data that support the therapeutic potential of our non-viral delivery system, which is being used in our current REQORSA® clinical oncology programs, presented before some of the world’s leading cancer researchers,” said Rodney Varner, President and Chief Executive Officer at Genprex. “The use of the ONCOPREX® Nanoparticle Delivery System to deliver the NPRL2 tumor suppressor gene positions Genprex to expand our clinical pipeline with a new drug candidate.”

“The preclinical data also provide further evidence that the ONCOPREX® Nanoparticle Delivery System has the ability to be successful using genes other than the TUSC2 gene that we are already using in clinical trials with REQORSA®,” stated Varner. “These compelling outcomes give us further confidence in the potentially broad-based application of our non-viral delivery system, which may provide a multitude of potential pipeline opportunities in the future.”

Genprex’s ONCOPREX® Nanoparticle Delivery System, is a novel non-viral approach utilizing lipid nanoparticles to deliver tumor suppressor genes that have been deleted during the course of cancer development. The platform allows for the intravenous delivery of various tumor suppressor genes, and potentially other genes, to achieve a therapeutic affect without the risk of toxicity often associated with viral delivery systems.

Featured Genprex-supported posters presented at AACR 2023 include:

Event: Americal Association of Cancer Research (AACR) Annual Meeting

Session Category: Immunology

Session Title: Combination Immunotherapies 2

Location: Section 22

Session Date and Time: Tuesday, April 18 from 1:30-5:00 p.m. ET

Title: “NPRL2 gene therapy induces effective antitumor immunity in KRAS/STK11 mutant anti-PD1 resistant metastatic human NSCLC in a humanizedmouse model”

Presenters: Jack A. Roth, MD, The University of Texas MD Anderson Cancer Center

Poster Board Number: 23

Abstract Presentation Number: 5120

The abstract entitled, “NPRL2 gene therapy induces effective antitumor immunity in KRAS/STK11 mutant anti-PD1 resistant metastatic human non-small cell lung cancer (NSCLC) in a humanized mouse model,” is available on the AACR website. The presentation reported results from this study, which investigated the antitumor immune responses to NPRL2 gene therapy on anti-PD1 resistant KRAS/STK11 mutant NSCLC in a humanized mouse model. In the study, humanized mice were treated with NPRL2 gene therapy, immunotherapy pembrolizumab (Keytruda®), or the combination. A dramatic antitumor effect was mediated by NPRL2 treatment, whereas pembrolizumab was ineffective. A significant antitumor effect was also found in non-humanized NSG mice, although the antitumor effect was greater in humanized mice, suggesting that the immune response played a role in inducing antitumor activity.

The study data suggest that NPRL2 gene therapy induces antitumor activity on KRAS/STK11 mutant anti-PD1 resistant tumors through DC mediated antigen presentation and cytotoxic immune cell activation.

A KRAS mutation occurs in approximately 25% of patients with NSCLC, and one study found that KRAS/STK11 combination mutations were found in approximately 6.5% of NSCLC patients.

“These data are encouraging because they not only validate Genprex’s non-viral oncology platform to deliver a variety of tumor suppressor genes, but they also provide further evidence of the important role that tumor suppressor genes play in cancer, particularly NSCLC,” said Mark Berger, MD, Chief Medical Officer at Genprex. “KRAS is the most frequent oncogene mutated in NSCLC, and KRAS mutations are often associated with resistance to drug therapy^[i]. Targeting KRAS/STK11 mutant NSCLC with the NPRL2 gene, and potentially with anti-PD1 as well, may provide therapeutic potential for this group of lung cancer patients.”

Genprex currently has three clinical trials evaluating the Company’s lead drug candidate, REQORSA® Immunogene Therapy (quaratusugene ozeplasmid) in lung cancer. The Acclaim-1 clinical trial, which received FDA Fast Track Designation, is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Tagrisso® (osimertinib) in patients with late-stage NSCLC with activating epidermal growth factor receptor (“EGFR”) mutations whose disease progressed after treatment with Tagrisso. The Acclaim-2 clinical trial, which received FDA Fast Track Designation, is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Keytruda® (pembrolizumab) in patients with late-stage NSCLC whose disease progressed after treatment with Keytruda. The Acclaim-3 clinical trial, expected to open for enrollment by the end of the third quarter of 2023, is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Tecentriq® (atezolizumab) in patients with extensive-stage small-cell lung cancer (SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as an initial treatment.

INDEPENDENT RESEARCHERS FIND THAT TUSC2, THE GENE DELIVERED BY GENPREX’S REQORSA®, FUNCTIONS AS A NOVEL TUMOR SUPPRESSOR FOR GLIOBLASTOMA

APRIL 18, 2023

Pre-clinical study results show TUSC2 overexpression reduces colony formation, neurosphere formation and promotes apoptosis in vitro, and suppresses tumor growth in vivo

Study adds to the growing body of research examining TUSC2 as a target for multiple other cancers

TUSC2 is the tumor suppressor gene used in the Company’s lead drug candidate, REQORSA® (quaratusugene ozeplasmid)

AUSTIN, Texas — (April 18, 2023) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that independent researchers recently presented preclinical data on the tumor suppressor gene, TUSC2, reporting that it functions as a novel tumor suppressor for glioblastoma. TUSC2 is the tumor suppressor gene that is reexpressed in tumors using REQORSA® Therapy treatment, Genprex’s lead drug candidate. Genprex has no affiliation with these researchers.

The independent researchers presented their abstract, titled, “Investigating TUSC2 for its tumor suppressive functions in glioblastoma and its role in gliomagenesis,” at the 2023 American Association for Cancer Research Annual Meeting on April 17. The abstract reports TUSC2 protein expression, but not mRNA expression, to be significantly decreased in glioblastoma as compared to normal brain. TUSC2 protein is destabilized in glioblastoma due to polyubiquitination by E3 ligase, neural precursor cell-expressed developmentally downregulated gene 4 (NEDD4), and degradation by the proteasome. The researchers determined that NEDD4 targets TUSC2 on lysine residue K71.

The researchers also reported that TUSC2 overexpression reduced colony formation and neurosphere formation and promoted apoptosis of glioblastoma cells in vitro, and suppressed tumor growth in vivo. Further, glioblastoma cells with CRISPR-mediated knockout (KO) of TUSC2 were highly aggressive in vitro and in vivo, demonstrating the role of TUSC2 as a novel tumor suppressor for glioblastoma.

In the study, researchers performed immunoprecipitation-mass spectrometry analysis to identify TUSC2-interacting proteins in both normal human astrocytes and glioblastoma cell lines. Results showed 95 and 88 TUSC2-interacting proteins in astrocytes and glioblastoma cell lines respectively, and 27 proteins were found to interact with TUSC2 in both astrocytes and glioblastoma.

“This research supports the growing body of studies evaluating TUSC2 as a target in oncology, and potentially an effective treatment, for many types of cancer,” said Rodney Varner, Chairman, President and Chief Executive Officer of Genprex. “We are encouraged by the increasing number of research institutions and independent researchers producing positive data on TUSC2, which provide additional support for REQORSA® and its therapeutic potential against cancers.”

REQORSA® Therapy is currently in development for the treatment of non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC). REQORSA® consists of the TUSC2 gene expressing plasmid encapsulated in non-viral nanoparticles made from lipid molecules (the Company’s ONCOPREX® Nanoparticle Delivery System) with a positive electrical charge. REQORSA® is injected intravenously and specifically targets cancer cells, taking advantage of leaky tumor vascularity, increased tumor pinocytosis, and attraction of positively charged lipid nanoparticles to negatively charged cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to cancer cells while minimizing their uptake by normal tissue.

According to the National Brain Tumor Society, glioblastoma is one of the most complex, deadly, and treatment-resistant cancers. More than 13,000 Americans were expected to receive a glioblastoma diagnosis in 2022. Glioblastoma accounts for 49.1 percent of all primary malignant brain tumors. There have only been five drugs and one device ever approved by the U.S. Food and Drug Adminstration for the treatment of glioblastoma.

Other independent researchers and studies have found that TUSC2 therapy may benefit other types of cancer, including head and neck, breast (including triple-negative breast cancer), renal cell (kidney), thyroid, and soft tissue sarcoma, as well as NSCLC and SCLC. For more information and additional studies supporting TUSC2, please refer to our Bibliography Page.

NEWS

GENPREX PUBLISHES POSITIVE CLINICAL DATA FROM PHASE 1 PORTION OF ACCLAIM-1 CLINICAL TRIAL EVALUATING REQORSA® IMMUNOGENE THERAPY IN NON-SMALL CELL LUNG CANCER AT THE 2023 ASCO ANNUAL MEETING

MAY 25, 2023

Results Show Combination of REQORSA® and Tagrisso® was Well Tolerated at All Three Dose Levels of Phase 1 Trial with Encouraging Evidence of Efficacy Observed

Read More

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GENPREX UNVEILS NEW VIDEO FEATURING CHIEF MEDICAL OFFICER DISCUSSING POSITIVE PRECLINICAL DATA WITH NPRL2 GENE THERAPY UTILIZING NON-VIRAL ONCOPREX® NANOPARTICLE DELIVERY SYSTEM

MAY 23, 2023

Chief Medical Officer Provides Overview of Preclinical Data Recently Presented at the 2023 American Association of Cancer Research (AACR) annual meeting

Read More

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GENPREX TO PARTICIPATE AND PRESENT AT UPCOMING MAY INDUSTRY AND INVESTOR CONFERENCES 

MAY 8, 2023

Presentations to Highlight Company’s Gene Therapies for Cancer and Diabetes

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GENPREX COLLABORATORS REPORT POSITIVE PRECLINICAL DATA WITH NPRL2 GENE THERAPY UTILIZING NON-VIRAL ONCOPREX® NANOPARTICLE DELIVERY SYSTEM IN NON-SMALL CELL LUNG CANCER AT THE 2023 AACR ANNUAL MEETING

APRIL 19, 2023

Provides Preclinical Validation of the ONCOPREX® Nanoparticle Delivery System with a Second Tumor Suppressor Gene

Read More

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INDEPENDENT RESEARCHERS FIND THAT TUSC2, THE GENE DELIVERED BY GENPREX’S REQORSA®, FUNCTIONS AS A NOVEL TUMOR SUPPRESSOR FOR GLIOBLASTOMA

APRIL 18, 2023

Pre-clinical study results show TUSC2 overexpression reduces colony formation, neurosphere formation and promotes apoptosis in vitro, and suppresses tumor growth in vivo

Read More

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GENPREX CEO COMMENDS FDA’S INITIATIVE TO ACCELERATE APPROVAL PROCESS FOR GENE THERAPIES

MARCH 23, 2023

Genprex is advancing its novel gene therapies for large patient populations with cancer and diabetes who currently have limited treatment options

Read More

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GENPREX TO PRESENT AT BIOPROCESSING SUMMIT CONFERENCE

MARCH 13, 2023

Genprex Chief Manufacturing and Technology Officer to Provide Insight on Manufacturing Gene Therapies

Read More

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GENPREX TO PARTICIPATE IN MARCH INVESTOR AND INDUSTRY CONFERENCES 

MARCH 8, 2023

Company to Showcase its Innovate Gene Therapy Programs in Oncology and Diabetes

Read More

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GENPREX, INC. ANNOUNCES $4 MILLION REGISTERED DIRECT OFFERING WITH A SINGLE, HEALTHCARE-FOCUSED INSTITUTIONAL INVESTOR

FEBRUARY 27, 2023

The gross proceeds from the offering are expected to be approximately $4 million, before deducting placement agent fees and other estimated offering expenses.

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GENPREX ANNOUNCES GROUNDBREAKING DATA FROM NON-HUMAN PRIMATE STUDY EVALUATING NOVEL GENE THERAPY TO TREAT TYPE 1 DIABETES AT 16^TH ANNUAL INTERNATIONAL CONFERENCE ON ADVANCED TECHNOLOGIES & TREATMENT FOR DIABETES 2023

FEBRUARY 23, 2023

Results show statistically significant decreases in insulin requirements, increases in c-peptide levels and improvements in glucose tolerance compared to baseline

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GENPREX SIGNS EXCLUSIVE LICENSE TO ADDITIONAL DIABETES TECHNOLOGY WITH THE UNIVERSITY OF PITTSBURGH

JANUARY 5, 2023

Technologies Licensed from University of Pittsburgh May Have the Potential to Provide Long-Term Efficacy and to Change the Course of this Disease for the Millions of Patients Around the World with Type 1 or Type 2 Diabetes

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GENPREX ANNOUNCES SELECTION OF PRECLINICAL DATA FOR ORAL PRESENTATION AT 16TH INTERNATIONAL CONFERENCE ON ADVANCED TECHNOLOGIES & TREATMENTS FOR DIABETES 

JANUARY 4, 2023

Exciting Data from University of Pittsburgh Researchers in Non Human Primates that Underpins Genprex’s Gene Therapy Program in Diabetes to be Showcased

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GENPREX STRENGTHENS DIABETES GENE THERAPY PROGRAM WITH LICENSE OF ADDITIONAL TECHNOLOGY FROM UNIVERSITY OF PITTSBURGH

DECEMBER 15, 2022

Technology for modulating autoimmunity expands intellectual property portfolio

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GENPREX RECEIVES SAFETY REVIEW COMMITTEE APPROVAL TO PROCEED TO FINAL COHORT IN ACCLAIM-1 PHASE 1 DOSE ESCALATION TRIAL OF REQORSA® IN COMBINATION WITH TAGRISSO® IN ADVANCED NON-SMALL CELL LUNG CANCER

DECEMBER 14, 2022

Recommendation to Advance to Increased Dose in Third and Final Cohort of Phase 1 Portion of Trial Indicates Favorable Safety Profile of Novel Gene Therapy in Solid Tumor Cancer

Read More

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MANAGEMENT

Check out the management team here: https://www.genprex.com/about/company-management/

Sincerely,

DISCLAIMER

THIS WEBSITE/NEWSLETTER IS OWNED SUBSIDIARY BY DEDICATED INVESTORS, LLC.

OUR REPORTS/RELEASES ARE A COMMERCIAL ADVERTISEMENT AND ARE FOR GENERAL INFORMATION PURPOSES ONLY. WE ARE ENGAGED IN THE BUSINESS OF MARKETING AND ADVERTISING COMPANIES FOR MONETARY COMPENSATION. WE HAVE BEEN COMPENSATED A FEE OF TWELVE THOUSAND FIVE HUNDRED USD BY A THIRD PARTY, SICA MEDIA LLC  FOR A ONE DAY GNPX AWARENESS CAMPAIGN. NEVER INVEST IN ANY STOCK FEATURED ON OUR SITE OR EMAILS UNLESS YOU CAN AFFORD TO LOSE YOUR ENTIRE INVESTMENT. THE DISCLAIMER IS TO BE READ AND FULLY UNDERSTOOD BEFORE USING OUR SERVICES, JOINING OUR SITE OR OUR EMAIL/BLOG LIST AS WELL AS ANY SOCIAL NETWORKING PLATFORMS WE MAY USE.PLEASE NOTE WELL: DEDICATED INVESTORS LLC AND ITS EMPLOYEES ARE NOT A REGISTERED INVESTMENT ADVISOR, BROKER DEALER OR A MEMBER OF ANY ASSOCIATION FOR OTHER RESEARCH PROVIDERS IN ANY JURISDICTION WHATSOEVER.RELEASE OF LIABILITY: THROUGH USE OF THIS WEBSITE VIEWING OR USING YOU AGREE TO HOLD DEDICATED INVESTORS LLC, ITS OPERATORS OWNERS AND EMPLOYEES HARMLESS AND TO COMPLETELY RELEASE THEM FROM ANY AND ALL LIABILITY DUE TO ANY AND ALL LOSS (MONETARY OR OTHERWISE), DAMAGE (MONETARY OR OTHERWISE), OR INJURY (MONETARY OR OTHERWISE) THAT YOU MAY INCUR. THE INFORMATION CONTAINED HEREIN IS BASED ON SOURCES WHICH WE BELIEVE TO BE RELIABLE BUT IS NOT GUARANTEED BY US AS BEING ACCURATE AND DOES NOT PURPORT TO BE A COMPLETE STATEMENT OR SUMMARY OF THE AVAILABLE DATA. DEDICATED INVESTORS LLC ENCOURAGES READERS AND INVESTORS TO SUPPLEMENT THE INFORMATION IN THESE REPORTS WITH INDEPENDENT RESEARCH AND OTHER PROFESSIONAL ADVICE. ALL INFORMATION ON FEATURED COMPANIES IS PROVIDED BY THE COMPANIES PROFILED, OR IS AVAILABLE FROM PUBLIC SOURCES AND DEDICATED INVESTORS LLC MAKES NO REPRESENTATIONS, WARRANTIES OR GUARANTEES AS TO THE ACCURACY OR COMPLETENESS OF THE DISCLOSURE BY THE PROFILED COMPANIES. NONE OF THE MATERIALS OR ADVERTISEMENTS HEREIN CONSTITUTE OFFERS OR SOLICITATIONS TO PURCHASE OR SELL SECURITIES OF THE COMPANIES PROFILED HEREIN AND ANY DECISION TO INVEST IN ANY SUCH COMPANY OR OTHER FINANCIAL DECISIONS SHOULD NOT BE MADE BASED UPON THE INFORMATION PROVIDED HEREIN. INSTEAD DEDICATED INVESTORS LLC STRONGLY URGES YOU CONDUCT A COMPLETE AND INDEPENDENT INVESTIGATION OF THE RESPECTIVE COMPANIES AND CONSIDERATION OF ALL PERTINENT RISKS. READERS ARE ADVISED TO REVIEW SEC PERIODIC REPORTS: FORMS 10-Q, 10K, FORM 8-K, INSIDER REPORTS, FORMS 3, 4, 5 SCHEDULE 13D.DEDICATED INVESTORS LLC IS COMPLIANT WITH THE CAN SPAM ACT OF 2003. DEDICATED INVESTORS LLC DOES NOT OFFER SUCH ADVICE OR ANALYSIS, AND DEDICATED INVESTORS LLC FURTHER URGES YOU TO CONSULT YOUR OWN INDEPENDENT TAX, BUSINESS, FINANCIAL AND INVESTMENT ADVISORS. INVESTING IN MICRO-CAP AND GROWTH SECURITIES IS HIGHLY SPECULATIVE AND CARRIES AND EXTREMELY HIGH DEGREE OF RISK. IT IS POSSIBLE THAT AN INVESTORS INVESTMENT MAY BE LOST OR IMPAIRED DUE TO THE SPECULATIVE NATURE OF THE COMPANIES PROFILED.THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 PROVIDES INVESTORS A SAFE HARBOR IN REGARD TO FORWARD-LOOKING STATEMENTS. ANY STATEMENTS THAT EXPRESS OR INVOLVE DISCUSSIONS WITH RESPECT TO PREDICTIONS, EXPECTATIONS, BELIEFS, PLANS, PROJECTIONS, OBJECTIVES, GOALS, ASSUMPTIONS OR FUTURE EVENTS OR PERFORMANCE ARE NOT STATEMENTS OF HISTORICAL FACT MAY BE FORWARD LOOKING STATEMENTS. FORWARD LOOKING STATEMENTS ARE BASED ON EXPECTATIONS, ESTIMATES, AND PROJECTIONS AT THE TIME THE STATEMENTS ARE MADE THAT INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES WHICH COULD CAUSE ACTUAL RESULTS OR EVENTS TO DIFFER MATERIALLY FROM THOSE PRESENTLY ANTICIPATED. FORWARD LOOKING STATEMENTS IN THIS ACTION MAY BE IDENTIFIED THROUGH USE OF WORDS SUCH AS PROJECTS, FORESEE, EXPECTS, WILL, ANTICIPATES, ESTIMATES, BELIEVES, UNDERSTANDS, OR THAT BY STATEMENTS INDICATING CERTAIN ACTIONS & QUOTE; MAY, COULD, OR MIGHT OCCUR. UNDERSTAND THERE IS NO GUARANTEE PAST PERFORMANCE WILL BE INDICATIVE OF FUTURE RESULTS. IN PREPARING THIS PUBLICATION, DEDICATED INVESTORS LLC HAS RELIED UPON INFORMATION SUPPLIED BY ITS CUSTOMERS, PUBLICLY AVAILABLE INFORMATION AND PRESS RELEASES WHICH IT BELIEVES TO BE RELIABLE; HOWEVER, SUCH RELIABILITY CANNOT BE GUARANTEED. INVESTORS SHOULD NOT RELY ON THE INFORMATION CONTAINED IN THIS WEBSITE. RATHER, INVESTORS SHOULD USE THE INFORMATION CONTAINED IN THIS WEBSITE AS A STARTING POINT FOR DOING ADDITIONAL INDEPENDENT RESEARCH ON THE FEATURED COMPANIES. DEDICATED INVESTORS LLC HAS NOT BEEN COMPENSATED FOR THIS EMAIL. THE ADVERTISEMENTS IN THIS WEBSITE ARE BELIEVED TO BE RELIABLE, HOWEVER, DEDICATED INVESTORS LLC AND ITS OWNERS, AFFILIATES, SUBSIDIARIES, OFFICERS, DIRECTORS, REPRESENTATIVES AND AGENTS DISCLAIM ANY LIABILITY AS TO THE COMPLETENESS OR ACCURACY OF THE INFORMATION CONTAINED IN ANY ADVERTISEMENT AND FOR ANY OMISSIONS OF MATERIALS FACTS FROM SUCH ADVERTISEMENT. DEDICATED INVESTORS LLC IS NOT RESPONSIBLE FOR ANY CLAIMS MADE BY THE COMPANIES ADVERTISED HEREIN, NOR IS DEDICATED INVESTORS LLC RESPONSIBLE FOR ANY OTHER PROMOTIONAL FIRM, ITS PROGRAM OR ITS STRUCTURE. DEDICATED INVESTORS LLC IS NOT AFFILIATED WITH ANY EXCHANGE, ELECTRONIC QUOTATION SYSTEM, THE SECURITIES EXCHANGE COMMISSION OR FINRA.

OUR NEW PROFILE IS:   (NASDAQ: TRNR)

_________________________________________________________________________________________

(TRNR) INTERACTIVE STRENGTH INC. D/B/A FORME ANNOUNCES CLOSING OF $12 MILLION INITIAL PUBLIC OFFERING

INTERACTIVE STRENGTH INC. AND AETHOS PARTNER TO BRING CUTTING EDGE FORME TRAINING TECHNOLOGY INTO HOTELS

CHECK OUT THE INVESTOR PRESENTATION HERE

_______________________________

Hello Everyone,

We have a profile back in our cross hairs that we took a look at earlier this month and dipped a bit after we initially brought it to your attention.  The IPO market certainly is crazy, wild and most of all unpredictable.

This one bottomed out at 3.21 and ran all the way back up to 7.13.

If you look at the chart below you will see that this one was in bull mode for a few sessions.

Monday we saw some profit taking and a healthy double digit pull back.

Right now is a good time to research this one as we saw it stabilize today.

Pull up TRNR right away.

TRNR (Forme), is a digital fitness platform that combines premium connected fitness hardware products with personal training and coaching (from real humans) to deliver an immersive experience and better outcomes for both consumers and trainers. They believe they are the pioneer brand in the emerging sector of virtual personal training and health coaching and that their products and services are accelerating a powerful shift towards outcome-driven fitness solutions.

The Forme platform delivers an immersive and dynamic at-home fitness experience through our VOD content, curated personalized fitness programming, Live 1:1 personal training, and other health coaching services, which are accessible via download or streaming through our connected fitness hardware products and via streaming through the Forme Studio app, which is available through iOS mobile devices and most iOS tablets and computers.

They offer two connected fitness hardware products, the Forme Studio (fitness mirror) and the Forme Studio Lift (fitness mirror and cable-based digital resistance). Both products are designed to provide a more integrated and immersive experience than similar connected fitness products currently on the market. The Forme Studio features a 43-inch 4K ultra high definition (“UHD”) touchscreen display, which is among the largest and highest definition screens in the connected fitness equipment market, and two front-facing 12 megapixel (“MP”), wide angle cameras designed to facilitate seamless live interaction with a trainer. The Forme Studio Lift also features two cable-based resistance arms that can provide up to 100 pounds of resistance per arm. Sales of their connected fitness hardware products have accounted for the substantial portion of revenue to date.

In addition to their connected fitness hardware products, they offer video on-demand (“VOD”) classes, personal training, and expert health coaching. Their health coaching services encompass guidance and coaching on nutrition, recovery, sleep, and other health and lifestyle categories. Personal training currently comprises the majority of our health coaching services.   All members who purchase the Forme Studio and Forme Studio Lift are able to access our VOD content library by creating a Forme account and signing up for their monthly membership. Once on the platform, each member is matched with a Fitness Concierge who works to understand specific needs and goals and then curates weekly fitness plans, comprised of On-Demand classes from our VOD content library. Their VOD content library includes hundreds of On-Demand classes spanning a wide range of modalities, including strength, recovery, barre, mind, Pilates, yoga, and other specialty categories.

For members who desire additional personalization, they recently launched our Custom Training offering which connects members with their personal trainers and is an upgrade to the VOD membership. This offering is currently charged at $149 per month and includes full access to the VOD content library.

INVESTMENT HIGHLIGHTS

Business Stage and Model offers high potential returns

Commercialization Opportunity

●  Development complete

●  Incremental capital leverages significant historical investment

Attractive Business Model

●  High value recurring revenues embedded in Hardware drives higher return on capital

●  Defensive growth profile

●  Marketplace opportunity to consolidate virtual training market due to quality

Market and Product provides growth and barriers to entry

Attractive Market and Consumer

● Connected Strength category is underpenetrated and larger than Cardio market

● Customer profile is affluent (>$200k HHI), and fitness spending is a relative staple in household budget

Differentiated Product

● Best smart home gym awards in 2023 from major publications

● Strength product and technology platform has high barrier to entry due to significant upfront capital investment required

● Unique trainer talent pool

Shareholder Profile for Long-Term Success

Strong Investor Support

● Invested $100M+ in developing technology platform

● Continued support from base of 400+ investors

Long-term Shareholders

● 18-month lockup for Company employees and certain existing investors

● After 6 months, early release upon 30 day VWAP reaching

• ○  150% of IPO price (1⁄3 released)
• ○  200% of IPO price (1⁄3 released)
• ○  250% of IPO price (1⁄3 released)

Home Fitness Market Statistics

• Global home fitness market value was USD 11.3 Billion in 2021 and expected to grow at CAGR of 4.9% from 2022 to 2030
• North America home fitness market revenue gathered more than 45% market share in 2021
• According to our analysis, 54% of the exercising Americans purchased fitness equipment
• Asia-Pacific home fitness market growth will record noteworthy CAGR during the forecast timeframe from 2022 to 2030
• Among application, female fertility segment accounted for over 70% of the overall market share in 2021
• Advent of COVID-19 pandemic is a primary driver for home fitness equipment market growth
• Surge in online sales for fitness equipment fuels the home fitness devices market

Home Fitness Market Growth Factors

• Rising prevalence of obesity
• Increasing consciousness among youth about healthy lifestyle
• Growth in government initiatives regarding healthy and fit lifestyles

INTERACTIVE STRENGTH INC. AND AETHOS PARTNER TO BRING CUTTING EDGE FORME TRAINING TECHNOLOGY INTO HOTELS

AUSTIN, TX and ZUG, Switzerland, May 22, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – Aethos, a leading lifestyle brand for community-centric hotels and member clubs in Europe, is excited to announce its brand partnership with Interactive Strength Inc. d/b/a FORME (Nasdaq: TRNR), a digital fitness service that combines award-winning smart home gyms with 1:1 personal training. As part of the partnership, Aethos will be the first hotel brand in Portugal, Spain and Italy to feature FORME’s revolutionary products in all its hotels and member clubs.

Aethos’ newest refuge in the Italian Alps, Aethos Monterosa, which is opening June 1st, will be the first destination to feature the FORME Studio in its Gym and Aethos Suites. The workout mirror with a 4K touch screen that makes it feel like the trainer is right there with you will complement the extensive wellbeing programming that the hotel offers; from an expansive indoor / outdoor spa, yoga, Pilates and boxing classes, to an indoor climbing hall.

At Aethos Milan, home to Aethos’ first members club, members will also have access to the devices and can access FORME’s personal training service at preferential rates.

“Aethos was founded on the belief that travel and hospitality should leave a positive and lasting impact on the body and mind,” says Benjamin Habbel, co-founder of Aethos. “As an experience-led hospitality brand we are committed to providing innovative solutions that help our guests travel and live healthier. Our partnership with FORME is a step towards changing travel experiences for conscious explorers.”

“We have always been believers in the transformative power of movement for the mind and body,” said Trent Ward, co-founder and CEO of FORME. “By partnering with Aethos, we have the opportunity to bring FORME’s best-in-class fitness to new customers in premium destinations around the globe. We are thrilled about this collaboration and its potential to achieve our shared goal of improving mental wellness and physical strength for more people. As a newly public company, we look forward to updating investors on future business development achievements such as with Aethos.”

About FORME
FORME is a digital fitness platform that combines premium smart home gyms with live virtual personal training and coaching to deliver an immersive experience and better outcomes for both consumers and trainers. FORME delivers an immersive and dynamic at-home fitness experience through two connected hardware products: 1. The FORME Studio (fitness mirror) and 2. The FORME Studio Lift (fitness mirror and cable-based digital resistance). The Studios uniquely transform to host a variety of workouts and activities, returning to an elegant, full-length mirror when not in use. In addition to the company’s connected fitness hardware products, FORME offers expert personal training and health coaching in different formats and price points through Video On-Demand, Custom Training, and Live 1:1 virtual personal training. FORME is listed on NASDAQ (symbol: TRNR)

About Aethos
Aethos is a community of hotels and clubs in Europe and was founded on the belief that travel and hospitality should be an experience that leaves a positive and lasting impact on the body, mind, and spirit. With destinations in Italy, France, and Portugal and more destinations in Spain opening soon, Aethos is a library of places that celebrate the curiosities of local culture.

NEWS

• INTERACTIVE STRENGTH INC. D/B/A FORME JOINS WEBULL CORPORATE COMMUNICATIONS SERVICE PLATFORMWebull’s Community of 1.3+ Million Active Participants can now Access the Profile of Interactive Strength d/b/a FORME on the Leading Mobile-First Brokerage Platform AUSTIN, TX, May 23, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – Interactive Strength Inc. d/b/a FORME (Nasdaq: TRNR), a digital fitness platform that combines premium connected fitness hardware products with live virtual personal training and coaching, announced that it has joined the new Webull Corporate Communications Service Platf
• GlobeNewswire•22 hours agoINTERACTIVE STRENGTH INC. AND AETHOS PARTNER TO BRING CUTTING EDGE FORME TRAINING TECHNOLOGY INTO HOTELSFORME FORME Studio AUSTIN, TX and ZUG, Switzerland, May 22, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – Aethos, a leading lifestyle brand for community-centric hotels and member clubs in Europe, is excited to announce its brand partnership with Interactive Strength Inc. d/b/a FORME (Nasdaq: TRNR), a digital fitness service that combines award-winning smart home gyms with 1:1 personal training. As part of the partnership, Aethos will be the first hotel brand in Portugal, Spain and Italy to featur
• GlobeNewswire•yesterdayFORME AND AETHOS PARTNER TO BRING CUTTING EDGE TRAINING TECHNOLOGY INTO HOTELSFORME Aethos Monterosa AUSTIN, TX and ZUG, Switzerland, May 22, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – Aethos, a leading lifestyle brand for community-centric hotels and member clubs in Europe, is excited to announce its brand partnership with FORME (Nasdaq: TRNR), a digital fitness service that combines award-winning smart home gyms with 1:1 personal training. As part of the partnership, Aethos will be the first hotel brand in Portugal, Spain and Italy to feature FORME’s revolutionary prod
• 
• ACCESSWIRE•21 days agoAEGIS CAPITAL CORP. ACTED AS SOLE BOOKRUNNER ON A $12 MILLION INITIAL PUBLIC OFFERING FOR INTERACTIVE STRENGTH INC. D/B/A FORME (NASDAQ:TRNR)Aegis Capital Corp. acted as Sole Bookrunner on a $12 Million Initial Public Offering for Interactive Strength Inc. d/b/a FORME (NASDAQ:TRNR).
• GlobeNewswire•21 days agoINTERACTIVE STRENGTH INC. D/B/A FORME ANNOUNCES CLOSING OF $12 MILLION INITIAL PUBLIC OFFERINGAUSTIN, TX, May 02, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – Interactive Strength Inc. (FORME) (Nasdaq: TRNR), a digital fitness platform that combines premium connected fitness hardware products with personal training and coaching, today announced the closing of its initial public offering of an aggregate of 1,500,000 shares of its common stock at a price to the public of $8.00 per share. The shares began trading on The Nasdaq Global Market on April 28, 2023 under the ticker symbol “TRNR.”

MANAGEMENT TEAM

TRENT A. WARD CHIEF EXECUTIVE OFFICER

Trent A. Ward is our co-founder and has served as our Chief Executive Officer and as a member of our board of directors since our inception in May 2017. Prior to founding Interactive Strength Inc., Mr. Ward served as an associate, analyst, and portfolio manager at Citadel LLC, a financial services company, from July 2006 to February 2014. From February 2014 to May 2017, Mr. Ward left Citadel LLC to begin investing in start-ups and pursuing various entrepreneurial endeavors, including starting the research and development for the precursor entity to us in October 2015. Mr. Ward holds a Bachelor of Science degree in Economics and a Bachelor of Applied Science degree in Engineering from the University of Pennsylvania.

DEEPAK M. MULCHANDANICHIEF TECHNOLOGY OFFICER

Deepak M. Mulchandani has served as our Chief Technology Officer and as a member of our board of directors since December 2021. Prior to joining Interactive Strength Inc., Mr. Mulchandani served as the Chief Product Officer and Executive Vice President of Engineering at Emerge Now Inc. (“Emerge”), a computer and electronic manufacturing company, from January 2020 to December 2021. Prior to joining Emerge, Mr. Mulchandani served as the Senior Vice President of Product Engineering at Peloton Interactive, Inc. (Nasdaq: PTON) from June 2017 to July 2019. Mr. Mulchandani holds a Bachelor of Science degree in Computer Science from Purdue University.

MICHAEL J. MADIGAN CHIEF FINANCIAL OFFICER

Michael J. Madigan has served as our Chief Financial Officer since February 2023, and previously served as our Senior Director of Finance from September 2022 to February 2023. Prior to joining Interactive Strength Inc. Mr. Madigan served in various roles at XPO Last Mile, Inc. (“XPO Last Mile”), a third party logistics company, including (i) Senior Director of Financial Planning and Analysis from October 2019 to September 2022, (ii) Senior Vice President of Finance from November 2016 to October 2019, and (iii) Vice President of Finance from 2013 to 2016. Prior to joining XPO Last Mile, Mr. Madigan served as Vice President of Finance at 3PD, Inc. and held various roles at PricewaterhouseCoopers. Mr. Madigan holds a Bachelor of Science degree in Accounting from Le Moyne College.

STUART BRYAN SENIOR DIRECTOR OF ACCOUNTING

Stuart Bryan has served as our Senior Director of Accounting since September 2022 and previously served as our Senior Director of Accounting & Finance from May 2022 to September 2022. Prior to joining Interactive Strength Inc., Mr. Bryan served as Senior Finance & Accounting Director at Vertiv Holdings Co. (NYSE: VRT) (“Vertiv”), a global infrastructure company, from March 2018 to May 2022. Prior to joining Vertiv, Mr. Bryan served in various roles at General Motors Company (NYSE: GM) (“GM”), an automobile manufacturing company, including (i) Assistant Finance Director from June 2014 to May 2018, (ii) Controller of a wholly owned subsidiary from May 2010 to June 2014, and (iii) Technical Accountant from October 2007 to May 2010. Prior to joining GM, Mr. Bryan was a Manager at Ernst & Young within the US Capital Markets group in London, England from April 2006 to October 2007, and as an auditor for Deloitte & Touche from January 1999 to April 2006. Mr. Bryan holds a Bachelor of Commerce – Honors degree (Accounting & Auditing) from the University of KwaZulu-Natal and a Bachelor of Commerce – Accounting Science degree from the University of South Africa.

Sincerely,

DISCLAIMER

THIS WEBSITE/NEWSLETTER IS OWNED SUBSIDIARY BY DEDICATED INVESTORS, LLC.

OUR REPORTS/RELEASES ARE A COMMERCIAL ADVERTISEMENT AND ARE FOR GENERAL INFORMATION PURPOSES ONLY. WE ARE ENGAGED IN THE BUSINESS OF MARKETING AND ADVERTISING COMPANIES FOR MONETARY COMPENSATION. WE HAVE BEEN COMPENSATED A FEE OF SEVENTEEN THOUSAND FIVE HUNDRED USD BY A THIRD PARTY, LEGENDS MEDIA LLC  FOR A ONE DAY TRNR AWARENESS CAMPAIGN. NEVER INVEST IN ANY STOCK FEATURED ON OUR SITE OR EMAILS UNLESS YOU CAN AFFORD TO LOSE YOUR ENTIRE INVESTMENT. THE DISCLAIMER IS TO BE READ AND FULLY UNDERSTOOD BEFORE USING OUR SERVICES, JOINING OUR SITE OR OUR EMAIL/BLOG LIST AS WELL AS ANY SOCIAL NETWORKING PLATFORMS WE MAY USE.PLEASE NOTE WELL: DEDICATED INVESTORS LLC AND ITS EMPLOYEES ARE NOT A REGISTERED INVESTMENT ADVISOR, BROKER DEALER OR A MEMBER OF ANY ASSOCIATION FOR OTHER RESEARCH PROVIDERS IN ANY JURISDICTION WHATSOEVER.RELEASE OF LIABILITY: THROUGH USE OF THIS WEBSITE VIEWING OR USING YOU AGREE TO HOLD DEDICATED INVESTORS LLC, ITS OPERATORS OWNERS AND EMPLOYEES HARMLESS AND TO COMPLETELY RELEASE THEM FROM ANY AND ALL LIABILITY DUE TO ANY AND ALL LOSS (MONETARY OR OTHERWISE), DAMAGE (MONETARY OR OTHERWISE), OR INJURY (MONETARY OR OTHERWISE) THAT YOU MAY INCUR. THE INFORMATION CONTAINED HEREIN IS BASED ON SOURCES WHICH WE BELIEVE TO BE RELIABLE BUT IS NOT GUARANTEED BY US AS BEING ACCURATE AND DOES NOT PURPORT TO BE A COMPLETE STATEMENT OR SUMMARY OF THE AVAILABLE DATA. DEDICATED INVESTORS LLC ENCOURAGES READERS AND INVESTORS TO SUPPLEMENT THE INFORMATION IN THESE REPORTS WITH INDEPENDENT RESEARCH AND OTHER PROFESSIONAL ADVICE. ALL INFORMATION ON FEATURED COMPANIES IS PROVIDED BY THE COMPANIES PROFILED, OR IS AVAILABLE FROM PUBLIC SOURCES AND DEDICATED INVESTORS LLC MAKES NO REPRESENTATIONS, WARRANTIES OR GUARANTEES AS TO THE ACCURACY OR COMPLETENESS OF THE DISCLOSURE BY THE PROFILED COMPANIES. NONE OF THE MATERIALS OR ADVERTISEMENTS HEREIN CONSTITUTE OFFERS OR SOLICITATIONS TO PURCHASE OR SELL SECURITIES OF THE COMPANIES PROFILED HEREIN AND ANY DECISION TO INVEST IN ANY SUCH COMPANY OR OTHER FINANCIAL DECISIONS SHOULD NOT BE MADE BASED UPON THE INFORMATION PROVIDED HEREIN. INSTEAD DEDICATED INVESTORS LLC STRONGLY URGES YOU CONDUCT A COMPLETE AND INDEPENDENT INVESTIGATION OF THE RESPECTIVE COMPANIES AND CONSIDERATION OF ALL PERTINENT RISKS. READERS ARE ADVISED TO REVIEW SEC PERIODIC REPORTS: FORMS 10-Q, 10K, FORM 8-K, INSIDER REPORTS, FORMS 3, 4, 5 SCHEDULE 13D.DEDICATED INVESTORS, LLC IS COMPLIANT WITH THE CAN SPAM ACT OF 2003. DEDICATED INVESTORS LLC DOES NOT OFFER SUCH ADVICE OR ANALYSIS, AND DEDICATED INVESTORS LLC FURTHER URGES YOU TO CONSULT YOUR OWN INDEPENDENT TAX, BUSINESS, FINANCIAL AND INVESTMENT ADVISORS. INVESTING IN MICRO-CAP AND GROWTH SECURITIES IS HIGHLY SPECULATIVE AND CARRIES AND EXTREMELY HIGH DEGREE OF RISK. IT IS POSSIBLE THAT AN INVESTORS INVESTMENT MAY BE LOST OR IMPAIRED DUE TO THE SPECULATIVE NATURE OF THE COMPANIES PROFILED.THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 PROVIDES INVESTORS A SAFE HARBOR IN REGARD TO FORWARD-LOOKING STATEMENTS. ANY STATEMENTS THAT EXPRESS OR INVOLVE DISCUSSIONS WITH RESPECT TO PREDICTIONS, EXPECTATIONS, BELIEFS, PLANS, PROJECTIONS, OBJECTIVES, GOALS, ASSUMPTIONS OR FUTURE EVENTS OR PERFORMANCE ARE NOT STATEMENTS OF HISTORICAL FACT MAY BE FORWARD LOOKING STATEMENTS. FORWARD LOOKING STATEMENTS ARE BASED ON EXPECTATIONS, ESTIMATES, AND PROJECTIONS AT THE TIME THE STATEMENTS ARE MADE THAT INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES WHICH COULD CAUSE ACTUAL RESULTS OR EVENTS TO DIFFER MATERIALLY FROM THOSE PRESENTLY ANTICIPATED. FORWARD LOOKING STATEMENTS IN THIS ACTION MAY BE IDENTIFIED THROUGH USE OF WORDS SUCH AS PROJECTS, FORESEE, EXPECTS, WILL, ANTICIPATES, ESTIMATES, BELIEVES, UNDERSTANDS, OR THAT BY STATEMENTS INDICATING CERTAIN ACTIONS & QUOTE; MAY, COULD, OR MIGHT OCCUR. UNDERSTAND THERE IS NO GUARANTEE PAST PERFORMANCE WILL BE INDICATIVE OF FUTURE RESULTS. IN PREPARING THIS PUBLICATION, DEDICATED INVESTORS LLC HAS RELIED UPON INFORMATION SUPPLIED BY ITS CUSTOMERS, PUBLICLY AVAILABLE INFORMATION AND PRESS RELEASES WHICH IT BELIEVES TO BE RELIABLE; HOWEVER, SUCH RELIABILITY CANNOT BE GUARANTEED. INVESTORS SHOULD NOT RELY ON THE INFORMATION CONTAINED IN THIS WEBSITE. RATHER, INVESTORS SHOULD USE THE INFORMATION CONTAINED IN THIS WEBSITE AS A STARTING POINT FOR DOING ADDITIONAL INDEPENDENT RESEARCH ON THE FEATURED COMPANIES. DEDICATED INVESTORS LLC HAS NOT BEEN COMPENSATED FOR THIS EMAIL. THE ADVERTISEMENTS IN THIS WEBSITE ARE BELIEVED TO BE RELIABLE, HOWEVER, DEDICATED INVESTORS LLC AND ITS OWNERS, AFFILIATES, SUBSIDIARIES, OFFICERS, DIRECTORS, REPRESENTATIVES AND AGENTS DISCLAIM ANY LIABILITY AS TO THE COMPLETENESS OR ACCURACY OF THE INFORMATION CONTAINED IN ANY ADVERTISEMENT AND FOR ANY OMISSIONS OF MATERIALS FACTS FROM SUCH ADVERTISEMENT. DEDICATED INVESTORS LLC IS NOT RESPONSIBLE FOR ANY CLAIMS MADE BY THE COMPANIES ADVERTISED HEREIN, NOR IS DEDICATED INVESTORS LLC RESPONSIBLE FOR ANY OTHER PROMOTIONAL FIRM, ITS PROGRAM OR ITS STRUCTURE. DEDICATED INVESTORS LLC IS NOT AFFILIATED WITH ANY EXCHANGE, ELECTRONIC QUOTATION SYSTEM, THE SECURITIES EXCHANGE COMMISSION OR FINRA.

 

OUR NEW PROFILE IS:  (NASDAQ: NCPL)

REVENUE GROWTH OF 48% YEAR-OVER-YEAR TO $5.4 MILLION IN THE FIRST 9 MONTHS OF 2023

OVER THE PAST NINE MONTHS NETCAPITAL HAS GENERATED SUBSTANTIAL REVENUE GROWTH WHILE GENERATING POSITIVE OPERATING AND NET INCOME

THE COMPANY BOASTS MORE THAN 100,000 USERS ALREADY WITH OVER $5O MILLION RAISED SO FAR

THIS ONE HAS AN EXTREMELY SMALL FLOAT OF JUST 4.2 MILLION ACCORDING TO YAHOO

READ THE INVESTOR PRESENTATION HERE

Hello Everyone,

The implementation of the Title III of the JOBS Act enabled early-stage companies to offer and sell securities to the general public for the first time.

The SEC followed with Reg CF, changing the landscape for private capital raising and investment. This allows general public to invest in private companies and enables private companies to advertise their security offerings.  This conditionally exempts securities sold under Section4(a)(6) from the registration requirements of the Securities and Exchange Act of 1934.

Enter Netcapital, Inc. (Nasdaq: NCPL)

They are disrupting the private capital markets and fundamentally altering the traditional private capital markets by. giving entrepreneurs greater access to investors.

Netcapital makes it possible for more businesses to help grow the economy, create jobs, and start making things that people love.  This gives any investor, not just the connected ones access to early-stage investments.

Low investment minimums and steady deal flow empower the average person to own shares in private companies they believe in.

Netcapital’s management consulting group, Netcapital Advisors, helps companies at all stages to raise capital. Netcapital Advisors provides strategic advice, technology consulting and online marketing services to assist with fundraising campaigns on the Netcapital platform. It also acts as an incubator and accelerator, taking equity stakes in select disruptive start-ups.

THE CEO OF NCPL TALKS TO JIM CRAMER ON MAD MONEY:

Take a look at some of the catalysts: 

• Incubate, accelerate, and empower private companies to grow
• Provide access to online private markets
• Market offerings to investors using digital technology
• Connect clients with our deep network of institutional and accredited investors

• Empowers private companies to raise capital online

• Democratizing access to capital and investments’
• More than 100,000 users

• Provides both accredited and non-accredited investors with access to new investment opportunities in private companies

• They provide marketing and strategic advice and takes equity positions in select companies with disruptive technologies
• Multi-trillion-dollar market opportunity

• Pandemic and regulatory changes enhancing growth
• Proven scalability
• Established track record enabling companies to raise capital
• Equity stakes provide upside optionality through possible exits (sale or IPO)

 

INVESTMENT HIGHLIGHTS

• Private capital markets reached $7.4 trillion at year-end 2020, $13 trillion expected over the next five years*
• Within this market, private equity represents the largest share, with assets of +$3 trillion and a 10-year CAGR of 10%
• $42 trillion held in retail investment accounts representing a large pool of potential account holders** Multiple industry tailwinds driving growth in digital capital markets

• Pandemic accelerating push to bring processes online
• Regulatory changes increasing digital funding opportunities
• Private equity outperformance drives growing investor demand for private investments
  Robust business model of fee income (Netcapital Funding Portal) plus equity stakes (Netcapital Advisors). Management team comprised of experienced institutional investors, angel investors and entrepreneurs.* Morgan Stanley
  **Boston Consulting Group

THE 3 MONTH CHART SHOWS THAT NCPL HAS BEEN MOVING NORTH ON LIGHT INTEREST AFTER BOUNCING OFF OF RECENT LOWS. THIS CHART IS LOOKING EXTREMELY BULLISH

PORTFOLIO

Trusted by over 100,000 investors to vet startup investments, KingsCrowd is the leader in ratings and analytics for online private markets. The company aggregates, analyzes, and rates companies raising on platforms like Netcapital to help investors make more informed decisions.

Deuce Drone solves the last mile delivery problem for “brick and mortar” retailers. The company designs, builds, and operates drone delivery systems, transforming retail stores into customer fulfillment centers. Deuce Drone provides a cost-effective, technology-driven solution for same-day delivery that allows retailers to compete with major e-commerce players.

Backed by famous venture capitalist Tim Draper, napster founder, Shawn Fanning, and co-creator of Guitar Hero, Kai Huang, Zelgor is an interactive entertainment company aiming to take over the universe with a new species of rambunctious alien characters called The Noobs. Noobs are a unique and original IP, introduced to the world through mobile games, multimedia content, and strategic partnerships.

Effective communicators close more deals. ChipBrain’s emotionally intelligent AI assistant provides real-time emotion, tone, and facial expression feedback in live conversations across text, voice, and video. Taking the guesswork out of identifying conversational cues, the company’s technology enables sales professionals to see at a glance how they are coming across to customers.

MustWatch brings your friends and favorite shows together all in one place. The Watch Party app makes it easy to find new shows, see what your friends are watching, and recommend great shows to each other. The company’s platform delivers targeted show recommendations based on the TV viewing tastes of users’ friends and family. It’s not a single streaming platform’s media catalog, but a cross-platform TV guide, crowdsourced from your friends and family.

C-Reveal’s proprietary technology, developed at Massachusetts General Hospital and Harvard University, helps the body’s immune system to identify and destroy cancer cells by inhibiting key enzymes that conceal the disease. This patent pending approach is designed to improve the efficacy of treating a broad range of cancers.

________________

“NETCAPITAL APPEALS TO ME BECAUSE I’VE HAD FIRSTHAND EXPERIENCE WITH THE PASSION AND SUPPORT THAT COMES FROM AN ENGAGED USER BASE, AND I’VE SEEN HOW THAT EXCITEMENT TRANSLATES INTO FUNDING.”  

——-JASON ROBINS  CO-FOUNDER AND CEO OF DRAFTKINGS

_________________________________________________________________________________________

NETCAPITAL ANNOUNCES THIRD QUARTER FISCAL 2023 FINANCIAL RESULTS INCLUDING YEAR-TO-DATE REVENUE GROWTH OF 48%

BOSTON, MA – March 16, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (the “Company”), a digital private capital markets ecosystem, today announced financial results for the third quarter and first nine months of fiscal year 2023 ended January 31, 2023.

“Over the past nine months, Netcapital has generated substantial revenue growth while generating positive operating and net income,” said Martin Kay, CEO of Netcapital Inc. “We have established a number of important strategic partnerships designed to create opportunities for clients and investors, while scaling and advancing our operating platform for continuing growth. Netcapital is executing on the vision for our brand – to break down traditional barriers and offer opportunities for anyone to invest in private companies. Along the way, we are turning customers and communities into owners and brand ambassadors for the businesses they love. We believe this is a powerful symbiotic relationship.”

Third Quarter Fiscal 2023 Financial Highlights

●  Revenue growth of 25% year-over-year to $2.3 million

●  Positive operating income of $571,000 compared to an operating loss of $135,000 in the year-ago quarter

●  Diluted earnings per share of $0.33

First Nine Months of Fiscal 2023 Highlights

●  Revenue growth of 48% year-over-year to $5.4 million

●  Positive operating income of $912,000 compared to an operating loss of $1.5 million in the first nine months of fiscal year 2022

●  Diluted earnings per share of $0.46

●  Paid down $1 million in debt, closed a $5 million underwritten public offering, and uplisted to Nasdaq in July 2022

For additional disclosure regarding Netcapital’s operating results, please refer to the Quarterly Report on Form 10-Q for the period ended January 31, 2023, which has been filed with the Securities and Exchange Commission.

NEWS

05/03/2023

Netcapital to Present at the Sidoti Micro-Cap Virtual Conference on May 10, 2023BOSTON, MA – May 3, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (the “Company”), a digital private capital markets ecosystem, today announced that Company Founder Jason Frishman will present at the Sidoti Micro-Cap Virtual Conference being held May 10-11, 2023.

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03/23/2023

Netcapital Named “Best Crowdfunding Platform” at FinTech Breakthrough Awards for Second Consecutive YearBOSTON, MA – March 23, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (the “Company”), a digital private capital markets ecosystem, today was named “Best Crowdfunding Platform” for the funding portal netcapital.com at the 7th Annual 2023 FinTech Breakthrough Awards, a premier awards program founded to…

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03/16/2023

Netcapital Announces Third Quarter Fiscal 2023 Financial Results Including Year-to-Date Revenue Growth of 48%BOSTON, MA – March 16, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (the “Company”), a digital private capital markets ecosystem, today announced financial results for the third quarter and first nine months of fiscal year 2023 ended January 31, 2023.

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03/06/2023

Netcapital to Report Third Quarter Fiscal 2023 Results on March 16thBOSTON, MA – March 6, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (the “Company”), a digital private capital markets ecosystem, announced today that it will report financial results for the third quarter of fiscal year 2023, ended January 31, 2023, after the U.S. equity markets close on Thursday, M…

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02/09/2023

Netcapital Establishes Referral Program with JD Merit SecuritiesBOSTON, MA – February 9, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (the “Company”), a digital private capital markets ecosystem, today announced that it has formed a referral agreement with JD Merit Securities, LLC, a leading boutique investment bank focused on serving middle-market technology-fo…

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01/11/2023

Netcapital to Present at the Sidoti Micro-Cap Virtual Conference on January 18, 2023BOSTON, MA – January 11, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (the “Company”), a digital private capital markets ecosystem, today announced that Founder Jason Frishman will present at the Sidoti Micro-Cap Virtual Conference on January 18, 2023. Date: Wednesday, January 18, 2023 Locatio…

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01/06/2023

Netcapital Announces Alternative Trading System (ATS) Partnership with Templum Markets LLCBOSTON, MA – January 6, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (the “Company”), a digital private capital markets ecosystem, today announced a new partnership between Netcapital Systems LLC, a Utah limited liability company and wholly owned subsidiary of the Company, and Templum Markets LLC, o…

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01/04/2023

Martin Kay Named CEO of Netcapital Inc.BOSTON, MA – January 4, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (the “Company”), a digital private capital markets ecosystem, today announced the appointment of Company director Martin Kay as Chief Executive Officer, effective January 3, 2023. In addition, the Company also announced that Dr. Ce…

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12/16/2022

Netcapital Inc. Announces Closing of Public OfferingBOSTON, MA – December 16, 2022 / Netcapital Inc. (Nasdaq: NCPL, NCPLW) (“Netcapital” or the “Company”), a digital private capital markets ecosystem, today announced the closing of its previously announced public offering of 1,247,000 shares of its common stock at a public offering price of $1.40 per…

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12/14/2022

Netcapital Inc. Announces Pricing of Public OfferingBOSTON, MA – December 13, 2022 / Netcapital Inc. (Nasdaq: NCPL, NCPLW) (“Netcapital” or the “Company”), a digital private capital markets ecosystem, today announced the pricing of an underwritten public offering of 1,247,000 shares of its common stock at a public offering price of $1.40 per share, f…

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MANAGEMENT TEAM

MARTIN KAY

CHIEF EXECUTIVE OFFICER

Martin Kay began his career at Bain & Company, where he filled roles of increasing responsibility to become a Partner and lead the global Telecom, Media, and Technology practice. Most recently Mr. Kay was a Managing Director with Accenture Strategy, where he led growth engagements for corporate clients and private equity firms. He is a co-founder of Accenture BLOOM, a digital strategy practice that invents, incubates, and scales new growth opportunities in partnership with clients. He was also the global Strategy lead for Accenture’s “Cloud First” program, driving innovation, growth, and digital transformation with cloud technologies. He joined the Netcapital’s board of directors in May 2022, after three decades as a successful leader, investor, advisor, and operator in early-stage digital ventures, including the original napster. Mr. Kay holds an MA in Physics from Oxford University and an MBA from the Stanford Graduate School of Business.

COREEN KRAYSLER, CFA

CHIEF FINANCIAL OFFICER

Coreen is a Chartered Financial Analyst, with over 30 years of investment experience. Formerly a Senior Vice President and Principal at Independence Investments, she managed several 5-star rated mutual funds as well as institutional accounts and served on the Investment Committee. She also worked at Eaton Vance, as a Vice President, Equity Analyst on the Large and Midcap Value teams. A specialist in financial services, household and consumer products, she guest lectures at local colleges and universities. Coreen received a B.A. in Economics and French, Cum Laude, from Wellesley College and a Master of Science in Management from MIT Sloan.

JASON FRISHMAN

FOUNDER

Jason Frishman is the Founder of Netcapital Funding Portal Inc. and serves as a mentor and advisor for early stage companies. He currently holds advisory positions at leading organizations in the financial technology ecosystem and has spoken as an external expert at Morgan Stanley, University of Michigan, YPO, and others. Jason has a background in the life sciences and previously conducted research in medical oncology at the Dana Farber Cancer Institute and cognitive neuroscience at the University of Miami, where he graduated summa cum laude with a B.S. in Neuroscience.

Sincerely,

DISCLAIMER

THIS WEBSITE/NEWSLETTER IS OWNED SUBSIDIARY BY DEDICATED INVESTORS, LLC.

OUR REPORTS/RELEASES ARE A COMMERCIAL ADVERTISEMENT AND ARE FOR GENERAL INFORMATION PURPOSES ONLY. WE ARE ENGAGED IN THE BUSINESS OF MARKETING AND ADVERTISING COMPANIES FOR MONETARY COMPENSATION. WE HAVE BEEN COMPENSATED A FEE OF FIFTEEN THOUSAND USD BY A THIRD PARTY, SICK MEDIA LLC  FOR A ONE DAY NCPL AWARENESS CAMPAIGN. NEVER INVEST IN ANY STOCK FEATURED ON OUR SITE OR EMAILS UNLESS YOU CAN AFFORD TO LOSE YOUR ENTIRE INVESTMENT. 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OUR NEW PROFILE IS:   (NASDAQ: PRPH)

2022 REVENUES TOTALED $122 MILLION

AS OF DEC. 31, CASH AND EQUIVALENTS TOTALED $17.4 MILLION WITH WORKING CAPITAL OF $44.8 MILLION

PRPH WILL RELEASE FIRST QUARTER FINANCIAL RESULTS ON THURSDAY

PROPHASE LABS CEO TED KARKUS NAMED ONE OF INC MAGAZINE’S 10 MOST INNOVATIVE HEALTHCARE LEADERS TO WATCH IN 2023

JUST DAYS AGO DIAMOND EQUITY RESEARCH INITIATED COVERAGE PRPH WITH A $20 PRICE TARGET

READ THE INVESTOR PRESENTATION HERE

Hello Everyone,

We have a new profile that we want you to research for tomorrow’s session.

This is a company that we have never covered before on this newsletter.

It has started to rebound tremendously off of the recent lows in March and has already started to head north.

ProPhase Labs, Inc. (Nasdaq: PRPH) (“ProPhase”) is a growth oriented and diversified diagnostics, genomics and biotech company that seeks to leverage its CLIA lab services to provide whole genome sequencing and research direct to consumers and build a genomics database to be used for further research. The Company provides traditional CLIA molecular laboratory services, including COVID-19 testing. The Company also operates Pharmaloz, a rapidly growing contract manufacturing subsidiary, and offers the TK Supplements line of dietary supplements, which are distributed in food, drug, and mass stores throughout the country.

ProPhase Diagnostics, Inc., a wholly owned subsidiary of ProPhase, offers a broad array of clinical diagnostic and testing services at its CLIA certified laboratories including polymerase chain reaction (PCR) testing for SARS-CoV-2 (COVID-19) and Influenza A and Influenza B. Critical to COVID-19 testing, ProPhase Diagnostics provides fast turnaround times for results. ProPhase Diagnostics also offers best-in-class rapid antigen tests to broaden its COVID-19 testing beyond RT-PCR testing. The Company has announced plans for the expansion of the lab to include traditional clinical testing and genomics sequencing.

Nebula Genomics, a rapidly growing and wholly owned subsidiary of ProPhase, focuses on genomics sequencing and testing technologies, a comprehensive method for analyzing entire genomes, including the genes and chromosomes in DNA. The data obtained from genomic sequencing may help to identify inherited disorders and tendencies, help predict disease risk, help identify expected drug response, and characterize genetic mutations, including those that drive cancer progression. The Company currently offers Nebula Genomics whole genome sequencing products direct-to-consumer online, with plans to sell in food, drug and mass (FDM) stores and to provide testing for universities conducting genomic research.

ProPhase BioPharma, Inc. (PBIO), a wholly owned subsidiary of ProPhase, was formed for the licensing, development and commercialization of novel drugs and compounds. Licensed compounds currently include Equivir (OTC/dietary supplement) and Equivir G (Rx), two broad based anti-virals, and Linebacker LB-1 and LB-2, two small molecule PIM kinase inhibitors. The Company is collaborating with the Dana Farber Cancer Institute to develop LB-1 as a cancer co- therapy. The Company also owns the exclusive rights to the BE-Smart Esophageal Pre-Cancer Diagnostic Screening test and related IP assets. The BE-Smart test remains under validation as a LDT. The test is focused on the early detection of esophageal cancer and is intended to provide health care providers and patients with data to help determine treatment options.

ProPhase Labs has decades of experience researching, developing, manufacturing, distributing, marketing, and selling OTC consumer healthcare products and dietary supplements under the TK Supplements® brand and Pharmaloz contract manufacturing subsidiary. ProPhase actively pursues strategic investments and acquisition opportunities for other companies, technologies, and products.

• The pioneers and leader in Whole Genome Sequencing with one of the most accurate, highest quality and price competitive solutions on the market.
• Offering deep insights for consumers, universities, and the healthcare industry with best-in-class tools and interpretation capabilities.

• State-of-the-art diagnostic laboratory services with a complete CLIA clinical lab offering, to include Chemistry, Immunoassay, Upper Respiratory, Hematology, Hemostasis and Urinalysis.
• Delivered millions of highly accurate Upper Respiratory laboratory diagnostics, including PCR, antigen and flu tests in our state-of-the-art CLIA laboratories.

• Developing groundbreaking compounds and products.
• Licensing and developing with the goal of commercializing Equivir (dietary supplement) and Equivir G (Rx), two broad based anti-virals, as well as Linebacker LB-1 and LB-2, two small molecule PIM kinase inhibitors for cancer treatment.

30+ years of OTC manufacturing services and consumer healthcare product development from non-GMO, Organic and/or Natural-based cough drops and lozenges for over-the-counter drugs to dietary supplement products.

• Clinically-backed consumer products promoting better health, energy, and sexual vitality available online, Walmart, Walgreens, CVS, Rite-Aid and more.

______________________________

PROPHASE LABS ANNOUNCES RECORD FINANCIAL RESULTS FOR THE YEAR ENDED DECEMBER 31, 2022

Company highlights key strategic initiatives to grow underlying value in 2023 and beyond

Company announces it is in strategic discussions to develop BE-Smart cancer test globally

Company to hold a conference call Tuesday, March 28, 2023, at 11:00AM ET

Garden City, NY, March 28, 2023 (GLOBE NEWSWIRE) — ProPhase Labs, Inc. (NASDAQ: PRPH), a growth oriented and diversified diagnostics, genomics and biotech company, today reported its financial and operational results for the year ended December 31, 2022.

Financial highlights for the full year ended December 31, 2022, include the following:

	●	Net revenue of $122.6 million for the year ended December 31, 2022, as compared to $79.0 million for the year ended December 31, 2021, an increase of approximately 55%.
	●	Net Income of $18.5 million, or $1.17 per diluted share, for the year ended December 31, 2022, as compared to net income of $6.3 million, or $0.41 per share, for the year ended December 31, 2021.
	●	Adjusted EBITDA of $38.6 million for the year ended December 31, 2022, as compared to adjusted EBITDA of $18.1 million for the year ended December 31, 2021.
	●	Cash, cash equivalents and marketable equity securities of $17.4 million and working capital of $44.6 million as of December 31, 2022.

Corporate highlights for the year ended December 31, 2022, and subsequently include the following:

	●	Acquired exclusive worldwide rights to develop and commercialize, subject to the necessary regulatory approvals, Equivir (dietary supplement) and Equivir G (Rx), two broad-based anti-virals.
	●	Acquired exclusive worldwide rights to develop and commercialize Linebacker (LB-1 and LB-2) for the treatment of cancer, inflammatory diseases or symptoms and memory-related syndromes, diseases or symptoms, including dementia and Alzheimer’s disease.
	●	Built out Nebula Genomics infrastructure, hired key management, added Dr. Russ Altman of Stanford University to our advisory board, and set the company on an accelerated growth path going forward.
	●	Returned a total of 1.3 million shares to the Company in 2022 from our common stock repurchase plan and cashless stock options exercised at a total value of $11.3 million.
	●	Paid two stock dividends to stockholders in 2022 totaling $9.3 million.
	●	Subsequent to year-end 2022, acquired exclusive worldwide rights to the BE-Smart Esophageal Pre-Cancer diagnostic screening test and related intellectual property assets.
	●	Subsequent to year-end 2022, received Board of Directors approval for a new $6 million stock repurchase program.

Ted Karkus, ProPhase Lab’s Chief Executive Officer, commented, “While working on Wall Street in the 90’s, I learned that when it comes to investing, particularly in small cap development stage companies, bet on the jockey and not the horse. My fellow shareholders, you have all bet on the right jockey. Our results over the past decade and in particular over the last few years, which have proven to be a very difficult period for many companies, have been extraordinary for our company, and 2022 was no exception. I am so proud of our entire management team for what we have collectively accomplished, and the platform that we have built together to provide an exciting future for our company and our shareholders.”

Mr. Karkus continued, “A decade ago, we inherited a cold brand with declining sales. Management had the skill and foresight to turn it around and sell it for $50 million dollars. Unlike the managements of many other companies, we rewarded shareholders with stock buybacks and special dividends and did not squander a single penny. We then looked for opportunities and were patient, only swinging at balls that we felt could result in homeruns for our company. With the emergence of COVID-19, we found an opportunity to help people while generating immediate and significant returns. The financial results speak for themselves.”

“I am truly pleased with our full year 2022 revenues of $122.6 million and adjusted EBITDA of $38.6 million,” continued Mr. Karkus. “One item to clarify is a one-time year-end charge of $5.9 million related to bad debt write-offs. This charge relates to the first half of 2022 when HRSA stopped reimbursing COVID-19 testing providers for claims without insurance. While this write-off is prudent, we still hope to collect insurance on many of these claims.”

“I believe that it is our destiny to build a multi-billion-dollar company together,” continued Mr. Karkus. “While our financial results have been stellar, we believe that our diversification strategy, which began in 2022, will make our previous successes seem trivial in comparison to what is yet to come. Over the past two years, we have taken advantage of the bear market in micro-cap development stage biotech and life sciences companies and licensed and/or acquired some fantastic assets that will gestate and become potentially billion-dollar franchises on their own.”

“As our COVID-19 and flu testing slows in 2023, we believe that the underlying value of our other subsidiaries will continue to grow rapidly and will more than make up for the slowdown in our diagnostics business and will reward our shareholders significantly over time. Several of these subsidiaries are already beginning to operate exceptionally well.”

Mr. Karkus elaborated, “Revenues from our Pharmaloz Manufacturing subsidiary are up approximately 100% year-over-year and we expect them to triple over the next two years. We already have the demand and are only limited by how quickly we can build out our capacity. Our Nebula Genomics subsidiary is growing even faster. We estimate revenues for this business will grow more than 100% in 2023 and that is before we leverage off of our superior retail distribution network. If we are successful in gaining acceptance in major retailers, then sales will grow even more dramatically. Retail is something we know better than anyone and we expect to execute on this in the near term.”

“We are confident that combining Nebula Genomics’ comprehensive genomic testing with our CLIA-certified lab capabilities will lead to faster turnaround times and lower price points, driving additional demand,” Mr. Karkus continued. “We also plan to offer low-pass genomic testing at significantly lower price points. This will allow us to leverage our distribution network of more than 40,000 food, drug, and mass retail stores to further expand direct-to-consumer and big-box retail distribution of Nebula’s Genomic sequencing products and services. Additional goals include the development of partnerships for Nebula Genomic’s proprietary library, research collaborations with universities, and leveraging the Nebula Genomics database. Furthermore, we believe our lab will be one of the most sophisticated in the nation and therefore could become the go to spot for all genetic sample processing. Each of these initiatives could significantly grow sales as we look forward to 2023 and beyond.”

Mr. Karkus continued, “We are very excited to be developing the BE-Smart Esophageal Cancer Test. Testing is ongoing at mProbe in collaboration with Dr. Hartley and The Mayo Clinic as well as with several other Key Opinion Leaders around the country. As described in recent press releases, we believe the BE-Smart test has multi-billion-dollar potential with minimal competition and significant unmet need. We expect to pursue initial commercialization of the BE-Smart test later this year as a laboratory developed test (LDT) and for research use only (RUO) for cash payment. Full commercialization backed by insurance is expected to commence in the first half of 2024 once CPT codes are obtained for insurance reimbursement. In parallel, we are also in current discussions to explore strategic opportunities to potentially develop, commercialize and distribute our BE-Smart test globally. These global opportunities may be even larger than in the United States. In the longer-term we feel that our knowledge gained from the BE-Smart test could also lead to some significant opportunities for therapeutic applications for Esophageal Adeno Carcinoma (EAC).”

“As shareholders, we look for catalysts to drive performance,” added Mr. Karkus. “We believe our ProPhase BioPharma subsidiary has exciting potential in both the short-term and the long-term. We are currently conducting clinical studies of Equivir (OTC/dietary supplement), a broad based anti-viral, and anticipate launching Equivir (OTC/dietary supplement) in the United States in the second half of this year. We believe that this product has significant potential as a dietary supplement and leverages our core infrastructure from when we owned the Cold-EEZE Cold Remedy brand. Our Linebacker cancer compound (LB-1) continues to demonstrate excellent pre-clinical results as a potential cancer co-therapy for several billion-dollar cancer drugs. These studies are continuing at Dana Farber Cancer Institute, and we look forward to reporting additional progress in the second quarter of this year. Longer term, we do not plan to spend significantly on this development path and plan to sell, license or joint venture Linebacker once Phase 1 human clinical studies are completed at minimal cost to ProPhase shareholders.”

“And finally, our diversification strategy for our diagnostics laboratory is proceeding nicely. Our clinical lab and our genomics lab have both been fully constructed with equipment installed. We are in the final stages of completing clinical validations to ensure testing accuracy for regulatory obligations. Our genomics laboratory is equipped with state-of-the-art genomics equipment, which provides us with the opportunity to potentially be the low-cost provider of all whole genome sequencing in the United States, as well as a leading provider of other genomics tests.
We will also continue to evaluate and pursue additional strategic and synergistic acquisitions to build our precision medicine and genomics research capabilities with the help of world-renowned genomics expert, George Church, co-founder of Nebula Genomics and Russ Altman, both of whom are advisors to ProPhase Labs.”

Mr. Karkus concluded, “As the largest shareholder in the Company, my primary concern has always been on creating value and a return on investment, on both an absolute and per share basis. While long-term performance is really just a series of good short-term executions, I remain focused on both the near-term and the long-term. In 2022, we returned a total of 1.3 million shares to the Company from the combination of our common stock repurchase plan and cashless stock options exercised at a total value of $11.3 million. Our recently announced new $6 million dollar stock repurchase program is a testament to our significant execution over the past two years as well as the Board’s confidence in our multi-faceted strategy to continue to build value for our shareholders long-term. Suffice it to say, the Board of Directors and I are excited for the future of our Company.”

Financial Results
Year Ended December 31, 2022

Net revenue for the year ended December 31, 2022 increased $43.6 million, or 55%, to $122.6 million compared to $79.0 million for the year ended December 31, 2021. The increase in net revenue was the result of a $39.8 million increase from diagnostic services, and a $3.8 million increase from consumer products. The increase in net revenue from diagnostic services was due to increased COVID-19 testing volumes performed as a result of the spread of the Omicron variant, which emerged in early 2022. Overall diagnostic testing volume increased from approximately 600,000 tests for the year ended December 31, 2021 to approximately 1,000,000 tests for the year ended December 31, 2022, of which 58% and 29% were reimbursed by the HRSA uninsured program, respectively. The average variable consideration received was $108.00 per adjudicated test for the year ended December 31, 2022 compared to $114.00 per adjudicated test for the year ended December 31, 2021 .

Cost of revenues for the year ended December 31, 2022 was $52.0 million, comprised of $39.9 million for diagnostic services and $12.1 million for consumer products. Cost of revenues for the year ended December 31, 2021 were $37.1 million comprised of $29.4 million for diagnostic services and $7.6 million for consumer products.

We realized a gross profit of $70.7 million for the year ended December 31, 2022, as compared to $42.0 million for the year ended December 31, 2021. The increase for the year ended December 31, 2022 compared to the year ended December 31, 2021 of $28.7 million attributable to an increase in diagnostic services, while consumer products remained flat. For the year ended December 31, 2022, our overall gross margin was 57.6% as compared to 53.1% for the year ended December 31, 2021. Gross margin for diagnostic services was 63.2% and 57.1% for the years ended December 31, 2022 and 2021, respectively. The increase in gross margin was principally due (i) increased efficiencies in our lab processing, (ii) decreased sample collection costs and (iii) a decrease in cost of testing materials. Gross margin for consumer products was 15.5% and 27.1% for the years ended December 31, 2022 and 2021, respectively. Gross margin for consumer products has historically been influenced by fluctuations in quarter-to-quarter production volume, fixed production costs and related overhead absorption, raw ingredient costs, inventory mark to market write-downs and timing of shipments to customers.  

Diagnostic expenses for the year ended December 31, 2022 were $12.0 million as compared to $9.2 million of diagnostic expenses for the year ended December 31, 2021. The increase in diagnostic expenses of $2.8 million was primarily due to increased COVID-19 testing volumes performed as a result of the spread of the Omicron variant, which emerged in early 2022, partially offset by a greater proportion of costs allocated to cost of revenues as a result of the nature of agreements with network providers.

General and administration expenses increased $11.9 million for the year ended December 31, 2022 to $34.4 million as compared to $22.5 million for the year ended December 31, 2021. The increase in general and administration expenses for the year ended December 31, 2022 as compared to the year ended December 31, 2021 was primarily related to an increase in personnel expenses and professional fees associated with our diagnostic services business. Additionally, we recorded a bad debt expense of $5.9 million representing a direct write-off of trade receivables we have determined to be uncollectible.

Research and development costs for the year ended December 31, 2022 were $0.7 million as compared to $0.5 million for the year ended December 31, 2021. The increase in research and development costs in fiscal 2022 as compared to fiscal 2021 was principally due to a decrease in personnel expenses associated with our diagnostics services business.

Our aggregate cash and cash equivalents and restricted cash as of December 31, 2022 were $9.1 million as compared to $8.7 million at December 31, 2021. Our working capital was $44.8 million and $45.8 million as of December 31, 2022 and 2021, respectively. The increase of $0.5 million in our cash and cash equivalents for the year ended December 31, 2022 was primarily due to the proceeds from the sale and maturities of marketable debt securities of $8.2 million, proceeds from dispositions of property and other assets of $0.5 million, and $28.7 million in cash provided by operating activities, offset by (i) purchases of marketable securities of $6.8 million, (ii) cash dividend payments of $9.3 million, (iii) repayment of note payable of $7.0 million, (iv) repurchase of common shares for $2.2 million, and (v) capital expenditures of $4.1 million.

COMPANY CEO NAMED TOP 10 MOST INNOVATIVE HEALTHCARE LEADERS TO WATCH IN 2023

ProPhase Labs CEO Ted Karkus Named One of Inc Magazine’s 10 Most Innovative Healthcare Leaders to Watch in 2023

Garden City, NY, April 28, 2023 (GLOBE NEWSWIRE) — ProPhase Labs, Inc. (NASDAQ: PRPH) (“ProPhase”), a next-generation biotech, genomics and diagnostics company, is pleased to announce that Ted Karkus, CEO, has been named one of Inc Magazine’s 10 Most Innovative Healthcare Leaders to Watch in 2023. The annual listing represents dynamic healthcare leaders redefining the world with their innovative products and leadership.

Mr. Karkus was recognized by Inc Magazine for his visionary leadership in the healthcare industry, as well as his dedication to driving innovation and improving patient outcomes. Under his guidance, ProPhase Labs has rapidly evolved from a legacy over-the-counter healthcare products and supplements company to a diversified, next-generation biotech, genomics and diagnostics company with multiple new products and subsidiaries.

In the article, Mr. Karkus was highlighted for his leadership stewarding ProPhase Labs through the c-virus pandemic, and his efforts to bring cutting-edge technologies and therapies to the healthcare industry through subsidiaries ProPhase Diagnostics, ProPhase BioPharma and Nebula Genomics. Mr. Karkus was instrumental in ProPhase’s quick pivot into the CV-19 testing business at the onset of the pandemic, generating over $200Mn in revenue over the past few years and fueling the company’s long-term growth and diversification strategies.

Mr. Karkus commented, “I am honored to be recognized by Inc Magazine as one of the 10 Most Innovative Healthcare Leaders to Watch for 2023. This recognition is a testament to the hard work and dedication of the entire ProPhase Labs team, and I look forward to continuing to drive innovation and improve patient outcomes in the years ahead. With Nebula Genomics, and the potential game changer diagnostics and therapeutics we are developing, including our BE-Smart Esophageal Cancer Test, Linebacker cancer compounds, and broad based Equivir anti-virals, as well as our new fully diversified, state-of-the-art clinical lab and genomics testing lab, I promise that we are just getting started and that there is a lot more to come!”

DIAMOND EQUITY RESEARCH INITIATES COVERAGE ON PROPHASE LABS INC. (NASDAQ: PRPH) $20 PRICE TARGET

NEW YORK, May 01, 2023 (GLOBE NEWSWIRE) — Diamond Equity Research, a leading equity research firm with a focus on small capitalization public companies has initiated coverage of ProPhase Labs Inc. (NASDAQ: PRPH). The in-depth 32-page initiation report includes detailed information on the ProPhase’s business model, services, industry, valuation, management, and risks.

The full research report is available here. Highlights from the report include:

• Diagnostics Business Enabling Pivot Toward Niche and Emerging Business Segments: ProPhase’s strategic evolution from a predominantly diagnostics-centric company to a multifaceted healthcare organization is underscored by its ability to capitalize on the success and cash generation of its diagnostics division. By investing in and growing healthcare companies such as genomics and biopharma, the company expands its market presence and fosters revenue diversification. The company’s management is ambitiously striving to transform ProPhase Labs into an all-encompassing healthcare powerhouse, with diagnostics and genomics pinpointing disease origins, contract manufacturing delivering top-tier production capabilities, and the biopharma division driving the development of cutting-edge therapies and treatments.
• Solid Financial Performance Showcasing Substantial Progress: The company reported strong growth across all its major business divisions for the year ended 2022. In 2022, ProPhase Labs reported revenue of $122.64 million, a significant increase from the $79.04 million recorded in 2021. This translates to a year-over-year (y-o-y) growth rate of 55.16%. In 2022, the diagnostics business itself experienced a 63.3% revenue growth, mainly due to increased COVID-19 testing volumes in response to the spread of the Omicron variant. Other divisions, such as contract manufacturing and genomics, have also reported impressive growth numbers. We anticipate a contraction in diagnostics revenue for 2023 and 2024 due to changing market dynamics. To offset this, ProPhase is focusing on growth in BioPharma, Contract Manufacturing, and Genomics divisions. The BioPharma division aims to fully commercialize its esophageal cancer test by H1 2024, while Contract Manufacturing and Genomics divisions are expanding their client base and distribution channels.

• Valuation: The market has been conservative in valuing ProPhase, possibly undervaluing its potential and expertise across multiple segments due to a lack of understanding of the unique strengths and synergies between divisions. The genomics business and esophageal pre-cancer test operate in promising markets with billion-dollar opportunities. The management remains strongly optimistic about its genomics business and expects over 100% growth in 2023. These businesses are regarded as somewhat de-risked, given their exceptional value proposition and the overall market undervaluation of the company. With its impressive competitive positioning, exceptional product offerings, and tremendous growth potential within the genomics market, it can be reasonably argued that Nebula, as an independent entity, has the potential to command a valuation in the range of $80-$120 million. Furthermore, the company’s Equivir and Linebacker portfolios are supported by a strong sound scientific background and present high upside optionality in terms of shareholder value creation. We assessed the company’s value at around $344 million or $20.00 per share using a combination of DCF and SOTP valuation methodologies, allocating equal weightage to both approaches. The DCF assumptions include a discount rate of 12.5% and a terminal growth rate of 1.5%. By using the median 2024e EV/Revenue multiple for each business division and their forecasted revenue numbers, we have determined the value of each segment. Subsequently, we aggregated these values to derive the overall SOTP valuation for the company, providing a detailed and nuanced perspective on the company’s worth. However, the valuation is contingent on the company’s successful execution and is subject to change with new information or progress in development and commercialization processes.
• Significant Momentum Across Nascent Business Domains: ProPhase is strategically positioned to capitalize on emerging opportunities across its contract manufacturing, genomics, dietary supplements, and biopharma divisions. The contract manufacturing division, PMI, has experienced significant revenue growth due to an expanding client base, an extended manufacturing agreement with Mylan, and facility improvements. Management expects a 200% increase in production capacity over the next two years, projecting to triple the division’s revenue from $8 million to $25 million by 2024. The genomics division, Nebula, is set to benefit from the growing demand for direct-to-consumer genetic testing, driven by factors such as customized healthcare solutions, precision medicine, and a decrease in whole genome sequencing costs. Nebula excels as the price and quality leader in the industry, providing valuable DNA testing insights and maintaining a competitive position among low-cost genotyping service providers. An extended distribution network and partnerships with research-focused universities will likely fuel further expansion in this field. The dietary supplements segment targets the growing health and wellness market, while the biopharma division develops innovative products, such as the BE-Smart esophageal cancer test, addressing urgent medical needs within a multi-billion-dollar market. It is being developed in collaboration with the Mayo Clinic and may be commercialized as early as Q1 2024. The biopharma division is also developing Linebacker, a cancer co-therapy with excellent pre-clinical results being developed in collaboration with Dana Farber Cancer Institute and Harvard University scientists. Additionally, ProPhase has displayed a remarkable ability to identify and execute value-enhancing acquisitions at highly favorable market valuations.
• Executives With a Proven Track Record of Execution and Adaptability: The leadership of ProPhase Labs, under Ted Karkus’ supervision, has skillfully navigated the company’s growth by organically developing the diagnostics business and swiftly growing it into a $100 million business. The management team has accomplished remarkable growth and profitability by prudently allocating resources and investing in advanced genomic sequencing tools and innovative drug-development projects. This adept approach to managing growth and resources highlights the team’s ability to deliver sustained success while continuously exploring new avenues in healthcare innovation. The team has also exhibited exceptional adaptability in modifying strategies, as demonstrated by their swift response to the discontinuation of the HRSA uninsured program for COVID-19 testing. Moreover, the company is capitalizing on its vast biopharma experience and utilizing genomics as a strategic advantage to create synergies across diagnostics, genomics, and biopharma business divisions. The management led by Ted Karkus’ successfully turned around the flagship Cold-EEZE brand, significantly growing revenues before selling the brand to Mylan for $50 million in 2017. Notably, Ted Karkus previously forced the restructuring, turnaround, and new direction for ID Biomedical, a Canadian biotech company, ultimately leading to its acquisition by GlaxoSmithKline for over $1.4 billion.

NEWS

MAY 08, 2023 8:30AM EDT

PROPHASE LABS HIRES DR. MATTHEW HALPERT TO DRIVE COMPANY’S KEY THERAPEUTIC AND DIAGNOSTIC ONCOLOGY PROGRAMS

MAY 04, 2023 8:30AM EDT

PROPHASE LABS TO HOST FIRST QUARTER 2023 FINANCIAL RESULTS CONFERENCE CALL ON THURSDAY, MAY 11, 2023 AT 11:00 A.M. EASTERN TIME

MAY 03, 2023 8:30AM EDT

PROPHASE LABS’ LINEBACKER-1 CANCER THERAPEUTIC SHOWS PROMISING MECHANISMS OF ACTION AS BOTH A MONO-THERAPY AND CO-THERAPY IN PRECLINICAL STUDIES ATTACKING A RANGE OF HARD-TO-TREAT CANCERS, INCLUDING LUNG AND GASTRIC CANCERS

APR 28, 2023 8:30AM EDT

PROPHASE LABS CEO TED KARKUS NAMED ONE OF INC MAGAZINE’S 10 MOST INNOVATIVE HEALTHCARE LEADERS TO WATCH IN 2023

APR 25, 2023 8:30AM EDT

PROPHASE LABS ANNOUNCES LAUNCH OF REDESIGNED CORPORATE WEBSITE

APR 18, 2023 8:00AM EDT

PROPHASE LABS TO PRESENT AT THE PLANET MICROCAP SHOWCASE: VEGAS 2023 ON WEDNESDAY, APRIL 26, 2023 & 1×1 MEETINGS ON THURSDAY, APRIL 27, 2023

MAR 28, 2023 8:00AM EDT

PROPHASE LABS ANNOUNCES RECORD FINANCIAL RESULTS FOR THE YEAR ENDED DECEMBER 31, 2022

MAR 21, 2023 8:00AM EDT

PROPHASE LABS TO HOST 2022 YEAR END FINANCIAL RESULTS CONFERENCE CALL ON TUESDAY, MARCH 28, 2023 AT 11:00 A.M. EASTERN TIME

MAR 15, 2023 8:00AM EDT

PROPHASE LABS ANNOUNCES NEW $6 MILLION STOCK REPURCHASE PROGRAM

MAR 13, 2023 8:00AM EDT

PROPHASE LABS ANNOUNCES DATA PRESENTATION FOR ITS BE-SMART ESOPHAGEAL CANCER TEST

MAR 07, 2023 8:00AM EST

PROPHASE LABS’ NEBULA GENOMICS SUBSIDIARY INTRODUCES LOWEST EVER NGS PRICING OF $249 FOR ITS WHOLE GENOME SEQUENCING DNA TEST

MAR 01, 2023 8:00AM EST

PROPHASE LABS ANNOUNCES COLLABORATION WITH MPROBE, INC. AND MAYO CLINIC FOR THE CONTINUING DEVELOPMENT OF BE-SMART ESOPHAGEAL PRE-CANCER DIAGNOSTIC SCREENING TEST

FEB 22, 2023 8:00AM EST

PROPHASE LABS ANNOUNCES PLANS TO INITIATE CLINICAL TRIAL OF EQUIVIR (OTC)

FEB 16, 2023 8:00AM EST

PROPHASE LABS ESOPHAGEAL CANCER EARLY DETECTION TEST (BE-SMART) FEATURED IN PEER-REVIEWED ARTICLE IN THE INTERNATIONAL JOURNAL OF MOLECULAR SCIENCE

FEB 15, 2023 8:00AM EST

PROPHASE LABS ANNOUNCES PLANS FOR MAJOR EXPANSION OF ITS PHARMALOZ MANUFACTURING, INC. SUBSIDIARY TO MEET GROWING DEMAND

FEB 06, 2023 8:00AM EST

PROPHASE LABS PROVIDES UPDATE ON LINEBACKER-1 CANCER CO-THERAPY PROGRAM AND OUTLINES DEVELOPMENT STRATEGY

JAN 05, 2023 8:00AM EST

PROPHASE LABS CLOSES ACQUISITION OF BE-SMART ESOPHAGEAL PRE-CANCER DIAGNOSTIC SCREENING TEST

DEC 19, 2022 8:30AM EST

PROPHASE LABS ACQUIRES RIGHTS TO NOVEL ESOPHAGEAL CANCER TEST

NOV 30, 2022 8:00AM EST

PROPHASE LABS TO PRESENT AT THE PLANET MICROCAP SHOWCASE: VIRTUAL 2022 ON WEDNESDAY, DECEMBER 7, 2022

NOV 10, 2022 8:00AM EST

PROPHASE LABS ANNOUNCES RECORD THIRD QUARTER 2022 FINANCIAL RESULTS

MANAGEMENT TEAM

TED KARKUS

Chairman & CEO

Ted Karkus, CEO and Chairman of ProPhase Labs, drives the company’s diverse and synergistic businesses with his successful track record in biomedical and health companies. He transformed ID Biomedical’s strategy and valuation from $25 million to $1.4 billion sale to GlaxoSmithKline.  As CEO of ProPhase Labs, he restructured the go-to-market strategy for the flagship product Cold-EEZE, turned around and significantly grew revenues, ultimately selling it for $50 million to Mylan.

ProPhase Labs is a fast-growing biotech, genomics and diagnostics company due to its commitment to growth, innovation, and execution excellence outlined in Ted’s high growth roadmap. He pivoted into industry leading CLIA labs, and then further diversified by acquiring genomics leader Nebula Genomics.  Constantly innovating, Ted then created ProPhase BioPharma to deliver antivirals, cancer tests and therapeutic cancer compounds. The new acquisitions and legacy businesses work to drive synergistic growth with multi-billion-dollar potential.

He holds a BS in Psychology from Tufts University with Magna Cum Laude Honors and an MBA in Finance from Columbia University School of Business with Beta Gamma Sigma Honors.

ROBERT A MORSE

Chief Financial Officer

Mr. Morse joined ProPhase Labs as Corporate Controller, served as Principal Financial Officer and Principal Accounting Officer prior to being promoted to CFO.

Prior to ProPhase Labs, Mr. Morse served as Global Controller and Chief Accounting Officer at multiple high-growth pre-IPO companies in the FinTech, EdTech and Asset Management sectors. Mr. Morse spent four years at MasterCard Worldwide and 10 years at The McGraw-Hill Companies and Standard & Poor’s. Mr. Morse began his career with four years in public accounting including two years with Ernst & Young LLP.

JASON KARKUS

President, ProPhase Diagnostics, Inc.

Jason drove explosive revenue growth at ProPhase Diagnostics, leading multiple areas including sales, business development, logistics operations, and account management. He oversaw the development of two CLIA-certified labs, generating approximately $200 million in revenues since 2021 and manages account managers and customer service reps who offer 24/7 service to exceed customer expectations. Jason now heads up business development for the rapid build-out of ProPhase’s clinical and genomic businesses.

With a background in sales and development at top real estate firms, Jason is a graduate of the University of Maryland.

ALICE LIOI

EVP/COO, ProPhase Diagnostics and ProPhase BioPharma

As head of all lab operations, Alice ensures high compliance standards, exemplary medical quality, service delivery, and client satisfaction with over 18 years of progressive laboratory leadership experience in both clinical and research. Prior to joining ProPhase, Alice was VP of Lab Operations at Quest Diagnostics, managed labs at Brookdale Hospital and Medical Center, and served as Administrative Director of Clinical and Anatomical Pathology Service at AdvantageCare Physicians, covering 36 medical facilities.

She graduated from SUNY Stony Brook with a Bachelor of Science in Clinical Laboratory Science and holds a NY State License as a Clinical Laboratory Technologist.

SERGIO MIRALLES

EVP/Chief Information Officer, ProPhase Diagnostics, Inc.

Sergio Miralles is an experienced IT Leader with over 12 years of experience in enterprise level Cybersecurity, Infrastructure, and Architecture. Sergio is responsible for ensuring a complete end-to-end technology solution that links its lab customers’ patient data via an interface to efficiently process and report results. Previously, Sergio founded and led a successful IT consulting firm overseeing 18 IT consultants. For the last five years, his primary focus has been on the medical, lab, and diagnostics business. Sergio holds several certifications from Cisco, ISC2, and CompTIA.

SAM BEELER

Chief Strategy Officer, Nebula Genomics

Sam is an accomplished healthcare executive with leadership experience spanning hospital-based medicine, multi-specialty private practice, clinical research, and community health. He has served in progressive enterprise leadership, strategy, and operations roles for The Advisory Board, Advantage Care Physicians, TeamHealth, PivotHealth and more. He is the co-founder of a disruptive clinical research and human performance lab with championship NFL, NHL, and MLB athletes, Olympic gold-medalists, Navy Seals, and high net-worth clientele. He was also appointed as Director of Health & Human Services for one of the most densely populated cities in the United States. Sam holds an MBA from Cornell SC Johnson Graduate School of Management, a Master of Science in Healthcare Policy & Research from Weill Cornell Graduate School of Medical Sciences, and a Bachelor’s degree in Philosophy from Rutgers University.

KAMAL OBBAD

SVP, Director of Sales and Marketing, Nebula Genomics

Kamal is co-founder of Nebula Genomics. He received his undergraduate degree at Harvard University and did graduate studies in computer science as a Gates-Cambridge Fellow at the University of Cambridge. Prior to founding Nebula, Kamal led teams at Google. For his work, Kamal has received multiple honors including being named to the Forbes 30 under 30 list.

DENNIS GRISHIN

Chief Scientific Officer, Nebula Genomics

Dennis is co-founder of Nebula Genomics. He received a Ph.D. in genetics from Harvard University. For his work, Dennis was awarded multiple fellowships, including German National Academic Foundation Fellowship, and named a Forbes 30 Under 30 in Healthcare.

Sincerely,

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RATHER, INVESTORS SHOULD USE THE INFORMATION CONTAINED IN THIS WEBSITE AS A STARTING POINT FOR DOING ADDITIONAL INDEPENDENT RESEARCH ON THE FEATURED COMPANIES. DEDICATED INVESTORS LLC HAS NOT BEEN COMPENSATED FOR THIS EMAIL. THE ADVERTISEMENTS IN THIS WEBSITE ARE BELIEVED TO BE RELIABLE, HOWEVER, DEDICATED INVESTORS LLC AND ITS OWNERS, AFFILIATES, SUBSIDIARIES, OFFICERS, DIRECTORS, REPRESENTATIVES AND AGENTS DISCLAIM ANY LIABILITY AS TO THE COMPLETENESS OR ACCURACY OF THE INFORMATION CONTAINED IN ANY ADVERTISEMENT AND FOR ANY OMISSIONS OF MATERIALS FACTS FROM SUCH ADVERTISEMENT. DEDICATED INVESTORS LLC IS NOT RESPONSIBLE FOR ANY CLAIMS MADE BY THE COMPANIES ADVERTISED HEREIN, NOR IS DEDICATED INVESTORS LLC RESPONSIBLE FOR ANY OTHER PROMOTIONAL FIRM, ITS PROGRAM OR ITS STRUCTURE. DEDICATED INVESTORS LLC IS NOT AFFILIATED WITH ANY EXCHANGE, ELECTRONIC QUOTATION SYSTEM, THE SECURITIES EXCHANGE COMMISSION OR FINRA.

OUR NEW PROFILE IS:   (NASDAQ: TRNR)

___________________________________

(TRNR) INTERACTIVE STRENGTH INC. D/B/A FORME ANNOUNCES CLOSING OF $12 MILLION INITIAL PUBLIC OFFERING

HOME FITNESS MARKET WAS 11.3BILL IN 2021 & WILL ATTAIN USD 17.3 BILLION BY 2030 GROWING AT 4.9% CAGR –  ACUMEN RESEARCH AND CONSULTING

CHECK OUT THE INVESTOR PRESENTATION HERE_

_______________________________

______________________________

Hello Everyone,

We have a brand new profile that just started trading last week after a successful $12Million IPO that is already sitting at a discount to the IPO price at current market levels.

TRNR (Forme), is a digital fitness platform that combines premium connected fitness hardware products with personal training and coaching (from real humans) to deliver an immersive experience and better outcomes for both consumers and trainers. They believe they are the pioneer brand in the emerging sector of virtual personal training and health coaching and that their products and services are accelerating a powerful shift towards outcome-driven fitness solutions.

The Forme platform delivers an immersive and dynamic at-home fitness experience through our VOD content, curated personalized fitness programming, Live 1:1 personal training, and other health coaching services, which are accessible via download or streaming through our connected fitness hardware products and via streaming through the Forme Studio app, which is available through iOS mobile devices and most iOS tablets and computers.

They offer two connected fitness hardware products, the Forme Studio (fitness mirror) and the Forme Studio Lift (fitness mirror and cable-based digital resistance). Both products are designed to provide a more integrated and immersive experience than similar connected fitness products currently on the market. The Forme Studio features a 43-inch 4K ultra high definition (“UHD”) touchscreen display, which is among the largest and highest definition screens in the connected fitness equipment market, and two front-facing 12 megapixel (“MP”), wide angle cameras designed to facilitate seamless live interaction with a trainer. The Forme Studio Lift also features two cable-based resistance arms that can provide up to 100 pounds of resistance per arm. Sales of their connected fitness hardware products have accounted for the substantial portion of revenue to date.

In addition to their connected fitness hardware products, they offer video on-demand (“VOD”) classes, personal training, and expert health coaching. Their health coaching services encompass guidance and coaching on nutrition, recovery, sleep, and other health and lifestyle categories. Personal training currently comprises the majority of our health coaching services.   All members who purchase the Forme Studio and Forme Studio Lift are able to access our VOD content library by creating a Forme account and signing up for their monthly membership. Once on the platform, each member is matched with a Fitness Concierge who works to understand specific needs and goals and then curates weekly fitness plans, comprised of On-Demand classes from our VOD content library. Their VOD content library includes hundreds of On-Demand classes spanning a wide range of modalities, including strength, recovery, barre, mind, Pilates, yoga, and other specialty categories.

For members who desire additional personalization, they recently launched our Custom Training offering which connects members with their personal trainers and is an upgrade to the VOD membership. This offering is currently charged at $149 per month and includes full access to the VOD content library.

Our Products – Premium Smart Home Gyms

INVESTMENT HIGHLIGHTS

Business Stage and Model offers high potential returns

Commercialization Opportunity

●  Development complete

●  Incremental capital leverages significant historical investment

Attractive Business Model

●  High value recurring revenues embedded in Hardware drives higher return on capital

●  Defensive growth profile

●  Marketplace opportunity to consolidate virtual training market due to quality

Market and Product provides growth and barriers to entry

Attractive Market and Consumer

● Connected Strength category is underpenetrated and larger than Cardio market

● Customer profile is affluent (>$200k HHI), and fitness spending is a relative staple in household budget

Differentiated Product

● Best smart home gym awards in 2023 from major publications

● Strength product and technology platform has high barrier to entry due to significant upfront capital investment required

● Unique trainer talent pool

Shareholder Profile for Long-Term Success

Strong Investor Support

● Invested $100M+ in developing technology platform

● Continued support from base of 400+ investors

Long-term Shareholders

● 18-month lockup for Company employees and certain existing investors

● After 6 months, early release upon 30 day VWAP reaching

• ○  150% of IPO price (1⁄3 released)
• ○  200% of IPO price (1⁄3 released)
• ○  250% of IPO price (1⁄3 released)

Home Fitness Market Statistics

• Global home fitness market value was USD 11.3 Billion in 2021 and expected to grow at CAGR of 4.9% from 2022 to 2030
• North America home fitness market revenue gathered more than 45% market share in 2021
• According to our analysis, 54% of the exercising Americans purchased fitness equipment
• Asia-Pacific home fitness market growth will record noteworthy CAGR during the forecast timeframe from 2022 to 2030
• Among application, female fertility segment accounted for over 70% of the overall market share in 2021
• Advent of COVID-19 pandemic is a primary driver for home fitness equipment market growth
• Surge in online sales for fitness equipment fuels the home fitness devices market

Home Fitness Market Growth Factors

• Rising prevalence of obesity
• Increasing consiousness among youth about healthy lifestyle
• Growth in government initiatives regarding healthy and fit lifestyles

INTERACTIVE STRENGTH INC. D/B/A FORME ANNOUNCES CLOSING OF $12 MILLION INITIAL PUBLIC OFFERING

AUSTIN, TX, May 02, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – Interactive Strength Inc. (FORME) (Nasdaq: TRNR), a digital fitness platform that combines premium connected fitness hardware products with personal training and coaching, today announced the closing of its initial public offering of an aggregate of 1,500,000 shares of its common stock at a price to the public of $8.00 per share. The shares began trading on The Nasdaq Global Market on April 28, 2023 under the ticker symbol “TRNR.”

Aegis Capital Corp acted as the sole underwriter.

The offering was made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from Aegis Capital Corporation, 1345 Avenue of the Americas, 27th Floor, New York, NY 10105, by e-mail at syndicate@aegiscap.com or by telephone at (212) 813-1010.

A registration statement relating to these securities has been filed with, and declared effective by, the U.S. Securities and Exchange Commission. Copies of the registration statement, as amended, can be accessed through the SEC’s website at www.sec.gov. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About FORME

FORME is a digital fitness platform that combines premium connected fitness hardware products with live virtual personal training and coaching to deliver an immersive experience and better outcomes for both consumers and trainers. FORME delivers an immersive and dynamic at-home fitness experience through two connective hardware products: 1. The FORME Studio (fitness mirror) and 2. The FORME Studio Lift (fitness mirror and cable-based digital resistance). The Studios uniquely transform to host a variety of workouts and activities, returning to an elegant, full-length mirror when not in use. In addition to the Company’s connected fitness hardware products, FORME offers expert personal training and health coaching in different formats and price points through Video On-Demand, Custom Training, and Live 1:1 virtual personal training.

NEWS

TUE MAY 2ND, 2023

• 10:46 AMINTERACTIVE STRENGTH INC. D/B/A FORME ANNOUNCES CLOSING OF $12 MILLION INITIAL PUBLIC OFFERING(GLOBENEWSWIRE)

THU APR 27TH, 2023

• 6:50 PMINTERACTIVE STRENGTH INC. D/B/A FORME ANNOUNCES PRICING OF $12 MILLION INITIAL PUBLIC OFFERING(GLOBENEWSWIRE)

MANAGEMENT TEAM

TRENT A. WARD CHIEF EXECUTIVE OFFICER

Trent A. Ward is our co-founder and has served as our Chief Executive Officer and as a member of our board of directors since our inception in May 2017. Prior to founding Interactive Strength Inc., Mr. Ward served as an associate, analyst, and portfolio manager at Citadel LLC, a financial services company, from July 2006 to February 2014. From February 2014 to May 2017, Mr. Ward left Citadel LLC to begin investing in start-ups and pursuing various entrepreneurial endeavors, including starting the research and development for the precursor entity to us in October 2015. Mr. Ward holds a Bachelor of Science degree in Economics and a Bachelor of Applied Science degree in Engineering from the University of Pennsylvania.

DEEPAK M. MULCHANDANICHIEF TECHNOLOGY OFFICER

Deepak M. Mulchandani has served as our Chief Technology Officer and as a member of our board of directors since December 2021. Prior to joining Interactive Strength Inc., Mr. Mulchandani served as the Chief Product Officer and Executive Vice President of Engineering at Emerge Now Inc. (“Emerge”), a computer and electronic manufacturing company, from January 2020 to December 2021. Prior to joining Emerge, Mr. Mulchandani served as the Senior Vice President of Product Engineering at Peloton Interactive, Inc. (Nasdaq: PTON) from June 2017 to July 2019. Mr. Mulchandani holds a Bachelor of Science degree in Computer Science from Purdue University.

MICHAEL J. MADIGAN CHIEF FINANCIAL OFFICER

Michael J. Madigan has served as our Chief Financial Officer since February 2023, and previously served as our Senior Director of Finance from September 2022 to February 2023. Prior to joining Interactive Strength Inc. Mr. Madigan served in various roles at XPO Last Mile, Inc. (“XPO Last Mile”), a third party logistics company, including (i) Senior Director of Financial Planning and Analysis from October 2019 to September 2022, (ii) Senior Vice President of Finance from November 2016 to October 2019, and (iii) Vice President of Finance from 2013 to 2016. Prior to joining XPO Last Mile, Mr. Madigan served as Vice President of Finance at 3PD, Inc. and held various roles at PricewaterhouseCoopers. Mr. Madigan holds a Bachelor of Science degree in Accounting from Le Moyne College.

STUART BRYAN SENIOR DIRECTOR OF ACCOUNTING

Stuart Bryan has served as our Senior Director of Accounting since September 2022 and previously served as our Senior Director of Accounting & Finance from May 2022 to September 2022. Prior to joining Interactive Strength Inc., Mr. Bryan served as Senior Finance & Accounting Director at Vertiv Holdings Co. (NYSE: VRT) (“Vertiv”), a global infrastructure company, from March 2018 to May 2022. Prior to joining Vertiv, Mr. Bryan served in various roles at General Motors Company (NYSE: GM) (“GM”), an automobile manufacturing company, including (i) Assistant Finance Director from June 2014 to May 2018, (ii) Controller of a wholly owned subsidiary from May 2010 to June 2014, and (iii) Technical Accountant from October 2007 to May 2010. Prior to joining GM, Mr. Bryan was a Manager at Ernst & Young within the US Capital Markets group in London, England from April 2006 to October 2007, and as an auditor for Deloitte & Touche from January 1999 to April 2006. Mr. Bryan holds a Bachelor of Commerce – Honors degree (Accounting & Auditing) from the University of KwaZulu-Natal and a Bachelor of Commerce – Accounting Science degree from the University of South Africa.

Sincerely,

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IN PREPARING THIS PUBLICATION, DEDICATED INVESTORS LLC HAS RELIED UPON INFORMATION SUPPLIED BY ITS CUSTOMERS, PUBLICLY AVAILABLE INFORMATION AND PRESS RELEASES WHICH IT BELIEVES TO BE RELIABLE; HOWEVER, SUCH RELIABILITY CANNOT BE GUARANTEED. INVESTORS SHOULD NOT RELY ON THE INFORMATION CONTAINED IN THIS WEBSITE. RATHER, INVESTORS SHOULD USE THE INFORMATION CONTAINED IN THIS WEBSITE AS A STARTING POINT FOR DOING ADDITIONAL INDEPENDENT RESEARCH ON THE FEATURED COMPANIES. DEDICATED INVESTORS LLC HAS NOT BEEN COMPENSATED FOR THIS EMAIL. THE ADVERTISEMENTS IN THIS WEBSITE ARE BELIEVED TO BE RELIABLE, HOWEVER, DEDICATED INVESTORS LLC AND ITS OWNERS, AFFILIATES, SUBSIDIARIES, OFFICERS, DIRECTORS, REPRESENTATIVES AND AGENTS DISCLAIM ANY LIABILITY AS TO THE COMPLETENESS OR ACCURACY OF THE INFORMATION CONTAINED IN ANY ADVERTISEMENT AND FOR ANY OMISSIONS OF MATERIALS FACTS FROM SUCH ADVERTISEMENT. DEDICATED INVESTORS LLC IS NOT RESPONSIBLE FOR ANY CLAIMS MADE BY THE COMPANIES ADVERTISED HEREIN, NOR IS DEDICATED INVESTORS LLC RESPONSIBLE FOR ANY OTHER PROMOTIONAL FIRM, ITS PROGRAM OR ITS STRUCTURE. DEDICATED INVESTORS LLC IS NOT AFFILIATED WITH ANY EXCHANGE, ELECTRONIC QUOTATION SYSTEM, THE SECURITIES EXCHANGE COMMISSION OR FINRA.

OUR NEW PROFILE IS:   (NASDAQ: NMTC)

STRATEGIC PARTNERSHIP WITH ZIMMER BIOMET (NYSE:ZBH, ~$27B MKT CAP) TO EXCLUSIVELY COMMERCIALIZE AND DISTRIBUTE EVO® DIAGNOSTIC ELECTRODES; ACCELERATED PAYMENT OF $3.5 MILLION RECEIVED IN AUGUST 2022

NEURONE® RECEIVES FDA 510(K) CLEARANCE TO MARKET ITS EVO® SEEG SYSTEM FOR LESS THAN 30 DAY USE

NEUROONE® SUCCESSFULLY COMPLETES INITIAL ANIMAL IMPLANT OF NOVEL THIN FILM PADDLE LEAD FOR SPINAL CORD STIMULATION

CHECK OUT THE INVESTOR PRESENTATION HERE

CHECK OUT THE COMPANY FACT SHEET HERE

Hello Everyone,

We have a brand new profile for tomorrow’s session that we have never brought you before.

This is a company that is known for wild swings.

Take a look at the chart:

*******BREAKING NEWS TODAY*********

NeuroOne® Announces U.S. Commercial Launch of Evo® sEEG Electrodes

Evo sEEGs complementary to Zimmer Biomet’s robotic neurosurgery platform; strong market opportunity for paired technologies

EDEN PRAIRIE, Minn., May 02, 2023 (GLOBE NEWSWIRE) — NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced the commercial launch of the Evo^® sEEG electrode product line in the United States. Zimmer Biomet holds exclusive worldwide distribution rights to NeuroOne’s Evo Cortical and sEEG product lines, and the Evo product line is expected to utilize Zimmer Biomet’s ROSA One^® Brain, a robotic platform that assists surgeons in planning and performing complex minimally invasive neurosurgical procedures.

Link To News: https://www.marketscreener.com/quote/stock/NEUROONE-MEDICAL-TECHNOLO-120796691/news/NeuroOne-Announces-U-S-Commercial-Launch-of-Evo-sEEG-Electrodes-43712433/

Pull up NMTC Immediately. 

NMTC is a medical technology company focused on the development and commercialization of a minimally invasive and high-definition/high-precision electrode technology platform used for acute diagnostics and chronic treatment across a wide range of neurologic conditions including epilepsy, Parkinson’s disease, dystonia, essential tremors, and chronic pain due to failed back surgeries. NeuroOne’s electrodes offer the potential to reduce the number of hospitalizations and surgical procedures, lower costs, and improve patient outcomes by offering combination diagnostic and therapeutic functions such as EEG recording and tissue ablation and/or chronic stimulation. In addition to NeuroOne’s FDA-cleared EVO® diagnostic electrodes, a combination recording and radiofrequency (RF) ablation technology, OneRF®, is currently under development as the Company’s first therapeutic device. Other research and development programs include revolutionary new thin-film-based (chronic) electrodes for spinal cord stimulation (SCS) and deep brain stimulation (DBS), and the potential application of the Company’s technology for artificial intelligence and machine learning.

NeuroOne® Successfully Completes Initial Animal Implant of Novel Thin Film Paddle Lead for Spinal Cord Stimulation.

Read the full news release here: https://t.co/tcQhWqh4fw$NMTC #N1MTC #MedTech pic.twitter.com/4m9gadsjUQ

— NeuroOne Medical Technologies Corporation (@N1MTC) March 16, 2023

NEUROONE® SUCCESSFULLY COMPLETES INITIAL ANIMAL IMPLANT OF NOVEL THIN FILM PADDLE LEAD FOR SPINAL CORD STIMULATION

Company is also developing a percutaneous (through a needle) delivery system for paddle leads

EDEN PRAIRIE, Minn., March 16, 2023 /PRNewswire/ — NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced the successful completion of an initial animal implant of its novel thin film paddle leads for spinal cord stimulation. The devices are intended for the treatment of patients with chronic back pain due to multiple failed back surgery syndrome, intractable low back and leg pain.

The study evaluated the feasibility of implanting a variety of sizes and shapes of ultra-thin paddle leads in a sheep model. A mini laminectomy surgical approach was used to gain access to the epidural space for device placement. All devices were easily advanced to the target location in under one minute. A competitive silicone-based lead was also placed for comparison purposes. The NeuroOne lead fit comfortably in the epidural space and the veterinary surgeon reported no concerns regarding the placement of the lead.

These results demonstrated feasibility for placement of a thin film paddle lead intended to treat chronic back pain due to multiple failed back surgeries. More testing will be completed to optimize the design and placement. The Company is also developing a percutaneous (through a needle) paddle lead placement system which would eliminate the need for an incision in the patient’s back. The preliminary bench top testing for this percutaneous approach has also been successfully completed.

Dave Rosa, CEO of NeuroOne, commented, “This represents a major milestone for the Company as we continue our development of innovative devices that provide therapeutic properties coupled with recording capabilities. The market opportunity for spinal cord stimulation is large and growing. We believe our technology can fill a market need for improved patient outcomes due in part to its potential ability to place a paddle device through a needle, provide a larger stimulation surface area of the spinal cord, better conformability with the tissue and improve battery life of devices, reducing the frequency of patient’s need to recharge or replace the battery.”

NEUROONE® AWARDED U.S. PATENT COVERING NOVEL AND PROPRIETARY THIN FILM ELECTRODE PLATFORM

New patent adds value to NeuroOne’s growing patent portfolio in the U.S. and abroad

EDEN PRAIRIE, Minn., March 7, 2023 /PRNewswire/ — NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announces it has been awarded a patent from the United States Patent and Trademark Office relating to its novel and proprietary electrode technology.

The patent, titled “Improved Neural Depth Probes and Related Systems and Methods,” adds to NeuroOne’s intellectual property portfolio, and is focused on a layered thin film neural depth electrode. The electrode could have potential applications in a wide variety of neurological procedures for both diagnostic and therapeutic use. Conditions that could potentially benefit from this technology include epilepsy, Parkinson’s disease, chronic back pain due to failed back surgeries, and mood- based disorders associated with depression, severe OCD, etc.

In addition to this patent, NeuroOne’s patent portfolio includes three licensed patents, eight pending U.S. applications, and several foreign applications covering a wide variety of thin-film electrode technologies, including both neural and spinal cord electrodes having unique properties to optimize the functionality and minimized profile of those electrodes, enabling less invasive surgeries. More specifically, the inventions described in the patent applications include electrodes and related devices with drug delivery capabilities, spinal cord stimulation electrodes, ablation electrodes, and electrodes with temperature sensing features.

Dave Rosa, CEO of NeuroOne, comments, “NeuroOne is committed to protecting our groundbreaking electrode technology with respect to device claims and proprietary manufacturing processes. With a plethora of patent applications both in the U.S. and overseas relating to procedures in epilepsy, Parkinson’s disease, chronic back pain and drug/gene delivery, we believe the Company is well positioned to impact a number of key neurological conditions with patent-protected novel electrodes. We look forward to continued success with our patent applications.”

LETTER TO SHAREHOLDERS

January 2022
Dear fellow shareholders,

In fiscal 2022 we made terrific strides in advancing our game-changing cortical, strip, grid and sEEG electrode technology for broad diagnostic and therapeutic applications. Today, NeuroOne provides a full line of electrode technology to address an estimated worldwide market of $100 million for patients requiring diagnostic brain mapping procedures. Our focus remains on patients suffering from epilepsy, chronic back pain, and Parkinson’s disease.

NeuroOne’s robust product suite has recently expanded beyond our first disruptive product introduction, the Evo® Cortical Electrode, to include our second FDA 510(k) cleared product, the Evo® sEEG Depth Electrode system, which is ready for commercial launch in the current calendar quarter. During 2022 we also made substantial development progress with our first combination system which includes both diagnostic and ablation capabilities.

The purpose of this letter is to share with you fiscal year 2022 and subsequent key highlights along with multiple exciting catalysts for NeuroOne in fiscal 2023.

Fiscal Year 2022 and Subsequent Highlights

• Clearly our most exciting and important accomplishment as a company to date was receiving U.S. Food and Drug Administration (FDA) 510(k) clearance for our Evo® sEEG product portfolio.
  FDA 510(k) clearance enables us to market the Evo sEEG (stereoelectroencephalography) Electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain. With this milestone, the full diagnostic functionality of our EVO sEEG System is complete.
• The first commercial order of Evo sEEG Electrodes for temporary (less than 30 days) use was shipped to Zimmer Biomet, another major achievement for our Company. Our manufacturing ramp and commercialization strategies are in place for near-term market introduction in collaboration with our distribution and development partner Zimmer Biomet (NYSE: ZBH).

• Significant progress was made in the development of our OneRFTM therapeutic ablation electrode system. Milestones completed include i) testing of hardware and software
  prototypes for the accompanying RF generator, ii) the design and
  testing of the OneRF system accessories, and iii) a second successfulanimal feasibility study at the Mayo Clinic. Designed to both record
  brain activity and ablate nervous tissue using the same electrode, our
  system offers the potential for a safer and less expensive combination electrode,
  intended to improve patient outcomes, reduce procedures and overall treatment
  cost. This system will potentially be our first therapeutic device, representing the next major phase in our Company’s development.
• We completed initial testing and advanced the development of electrodes for chronic stimulation and recording. Our initial target is the spinal cord stimulation market, a $3 billion market in the U.S. alone. We are designing our devices to utilize percutaneous delivery systems (non- surgical placements) that require less battery energy and expanded tissue coverage as compared to standard electrodes placed percutaneously1. Since our electrodes are intended to be implanted for long-term use, theyhave advanced insulation against
  fluid permeation and greater durability than devices intended for less than 30 days use. Prominent key opinion leaders joined our new Physician Advisory Board to help guide our development of both the electrode and device delivery system(s).
• We increased our financial runway and maintain capital resources to support upcoming commercial and development catalysts. In August 2022 we received an accelerated $3.5 million payment from Zimmer Biomet related to certain milestone events, as part of an amendment to our distribution and development agreement. Earlier in fiscal year 2022 we completed a public offering, raising gross proceeds of $13.4 million.
• Additional partners were qualified for manufacturing. With an expanded supply chain, we are well- equipped to meet increased product demand with the market launch of the Evo sEEG.
• We bolstered our management team by hiring key positions in Research and Development and Quality Control. Our leadership team holds deep expertise in thin film electrode technology research and development, marketing, finance, quality control, regulatory affairs, and business development. The Company also benefits from a world-class board of directors and esteemed scientific and physician advisory boards.
• 1 North RB, Kidd DH, Olin JC, Sieracki JM. Spinal cord stimulation electrode design: prospective, randomized, controlled trial comparing percutaneous and laminectomy electrodes-part I: technical outcomes. Neurosurgery. Aug 2002;51(2):381-9; discussion 389-90.

• NeuroOne joined the University of Minnesota in a National Institutes of Health (NIH) grant submission. NIH funding would support our joint development of a chronic cortical electrode capable of both recording and stimulation. We believe this device will provide new opportunities for clinical studies in many areas, including chronic pain, substance use disorder, depression, obsessive compulsive disorder, and other mental health conditions.
• Our corporate and scientific teams presented and promoted NeuroOne at numerous high-profile events in the U.S. and overseas. Our data was presented to the scientific community at the Neuroelectronic Interfaces Gordon Research Conference, Congress of Neurological Surgeons, Society for Neuroscience, and American Epilepsy Society meetings. We exhibited our Evo electrode product family with Zimmer Biomet at the Congress of Neurological Surgeons annual meeting and the American Epilepsy Society annual meeting. The Evo sEEG implantation accuracy study was featured in a podium presentation at the Biennial Meeting of the World Society for Stereotactic &Functional Neurosurgery, held in South Korea. Our full team participated in a Nasdaq Stock Market Closing Bell ceremony to celebrate our Evo sEEG FDA 510(k) clearance milestone.Fiscal Year 2023 Potential Catalysts

• Commercial launch of Evo sEEG Electrodes. We expect to begin the commercial launch of our Evo sEEG electrodes with Zimmer Biomet in the first calendar quarter of 2023. We have already shipped the first commercial order and will continue to build up inventory to meet product forecasts and additional orders in house.
• Continuing ablation electrode development. OneRF is on track for submission of a 510(k) application to the FDA in the second quarter of calendar year 2023.
• Continuing spinal cord stimulation (SCS) electrode development. In 2023, we will continue to refine our chronic spinal cord electrode design based on customer feedback and conduct additional pre- clinical bench and/or animal tests to further validate our value proposition.
• Exploration of additional partnerships. We believe there may be opportunities to establish mutually beneficial relationships with companies that could leverage our core technology. Our technology enables, complements, and/or competes with a number of companies that are in the market or attempting to enter the market with diagnostic or therapeutic technologies to treat brain related disorders. In addition, our technology may have application in cardiovascular, orthopedic, and pain related indications that could benefit from a high-fidelity thin film electrode product that can provide stimulation and/or ablation therapies.
• Exploration of new indications. As mentioned previously, we are excited about working with the University of Minnesota to develop an electrode that could be used as part of a closed loop cortical system that has the potential to provide both recording and therapeutic stimulation for multiple indications, one of which includes mental health conditions, an exciting market that is exploring more effective treatments in addition to pharmacological care.

In closing, the NeuroOne team made great progress in fiscal 2022 on multiple fronts including commercialization, product development, and financing. We are in a strong position to continue executing meaningful advances in electrode technology for a variety of neurological applications.

_____

NeuroOne® Reports First Quarter Fiscal Year 2023 Financial Results and Provides Corporate Update.

Read the full news release here: https://t.co/USfvjhIhLE $NMTC #BusinessUpdate #N1MTC #NeuroOne pic.twitter.com/jta14I7rZD

— NeuroOne Medical Technologies Corporation (@N1MTC) February 14, 2023

Evo® Cortical ElectrodeNeuroOne offers a breakthrough thin-film electrode for the diagnosis of various neurological conditions. Evo’s high- definition, minimally invasive technology delivers major advantages over the limitations of legacy silicone-based electrodes, hampered by the lack of innovation and progress in electrode technology, that are still widely used today.o Over 7 times thinner and 8 times lighter than comparable silicone electrodes used in legacy products. o Flexibility, thinness, and reduced weight facilitates potential for minimally invasive placement.o Reduced inflammation as compared to silicon-based legacy electrodes based on published testing by Mayo.Evo cortical electrode technology has received 510(k) clearance from the FDA for recording, monitoring, and stimulating brain tissue for up to 30 days.

Evo® sEEG Electrode

The Evo sEEG electrode technology offers stereoelectrocencephalography recording, spinal cord stimulation, brain stimulation and ablation solutions. The first clinical case using the Evo sEEG electrode was recently performed by Dr. Robert Gross at Emory University for intraoperative brain mapping at the subsurface level of the brain.

The sEEG electrode has received FDA 510(k) clearance from the FDA for use of less than 24 hours. A 510(k) for Evo sEEG electrode technology for up to 30 day use has been submitted to the FDA.

Brain Monitoring – Understanding What Allows Us To Sense, Move, Think And Feel

Neurons

86 BILLION NEURONS

Neurons communicate through electrical and chemical signals. The specific properties of the neurons composing a brain area and their connections with neurons in other brain areas, define the function of a brain area (e.g. language, vision, movement).

Monitoring Neural Activity

THEY CAN RECORD ELECTRICAL SIGNALS

There are different ways to record and monitor neural activity. Their solution is to provide electrodes that are placed on top of or within the brain and capture the activity of a group of neurons located underneath/around each contact. The signals recorded are called intracranial electroencephalogram (iEEG) or electrocorticography (ECoG) signals. The shape, amplitude and frequency of these electrical signals provide a readout of the activity of that brain area.

Monitoring Neurological Disorders

Neurological diseases may be associated with disturbances in neural activity and connectivity between brain areas. The changes in the shape, amplitude and frequency of recorded electrical signals may be used to identify areas with altered activity.

Epilepsy

Epilepsy is the disease associated with spontaneously recurring seizures. A seizure is a sudden, uncontrolled electrical disturbance in the brain. It can cause changes in behavior, movements or feelings, and in levels of consciousness. There are different types of seizures and their characterization and classification helps guide the treatment.

There are more than twenty seven FDA-approved drugs for the treatment of seizures. However, in ~1/3 of the patient’s medication fails to control their seizures. These patients are candidates for surgical options.

Evo® Cortical Electrode

Cortical or subdural electrodes are used in electrocorticography (ECoG) or intracranial electroencephalography (iEEG) surgeries to monitor, record and stimulate the surface of the brain for up to 30 days. The company’s Evo cortical electrode portfolio consists of various contact configurations of strip and grid electrodes. (Rx only)

The Evo Advantage 

Decreased Immunological Response – The Evo Electrode is over 7 times thinner than a silicone electrode. The flexibility and reduced volume should reduce pain and edema.

The Evo’s polyimide substrate has properties like increased flexibility, reduced volume, and decreased immunological response, which should reduce signal artifacts.

Single Tail Design – The single thin tail design allows the implanted electrode tail to be tunneled through one incision which should reduce infection risk and procedure time.

Reduced Cable Management – A disposable cable assembly is sent with each Evo Electrode as an electrode kit, removing the need to source the correct cables for each electrode being used in surgery. Also, hospital resources are freed from the management of sterilizing and storing individual electrode cable assemblies.

How NeuroOne’s Thin Film Electrode Technology is Different

In comparison to currently available technologies, our electrodes are manufactured with polyimide thin film. Our electrodes are designed to reduce trauma to the brain by allowing a less invasive implant due to the flexibility, thinness and reduced weight of the electrode.

Furthermore, the potential to significantly increase the resolution of brain recordings may enable the usage of powerful computing techniques, such as machine learning and artificial intelligence.

Caution: US Federal law restricts this device to sell by or on the order of a physician

Two FDA-Cleared Devices and Counting 

Are you beginning to understand that NeuroOne is not just “another” MedTech company? In fact, their Evo Cortical and sEEG Electrodes are both FDA approved!

What they are doing right now has incredible implications for the future of the medical industry.

So much so that the technologies below could be commonplace and in wide use across the globe.

“Electrochemical Characterization of the First FDA-Cleared Thin-Film Electrodes for Recording and Stimulation of Brain Activity”

Congratulations to the NeuroOne team and our Medical/Clinical Liaison, Aura Kullmann, for the presentation at @NANS_ION Annual Meeting last week. pic.twitter.com/XthErbhBZW

— NeuroOne Medical Technologies Corporation (@N1MTC) January 18, 2023

NEUROONE® RECEIVES FDA 510(K) CLEARANCE TO MARKET ITS EVO® SEEG SYSTEM FOR LESS THAN 30 DAY USE

Company focused on manufacturing ramp for commercialization in partnership with Zimmer Biomet

EDEN PRAIRIE, Minn., Oct. 25, 2022 /PRNewswire/ — NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (NeuroOne or the Company), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Evo sEEG Electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

The Company’s Evo Cortical and sEEG Electrodes are a portfolio of hi-definition thin film electrodes. Potential advantages include increased signal clarity and reduced noise; better tactile feedback during insertion into brain tissue; and faster order fulfillment due to an automated manufacturing process.

As previously reported, NeuroOne is also advancing a pipeline of therapeutic electrode technologies for brain tissue ablation and chronic stimulation use for DBS (deep brain stimulation) and spinal cord stimulation for chronic back pain.  These therapeutic electrode technologies represent addressable markets valued between $500 million and $6 billion.

MAJOR CATALYSTS

• Disruptive next-generation diagnostic electrodes advancing a new era in neuroscience; foundational technology initially developed in collaboration with Mayo Clinic, a shareholder of the Company.
• Strategic partnership with Zimmer Biomet (NYSE:ZBH, ~$27B mkt cap) to exclusively commercialize and distribute EVO® diagnostic electrodes; accelerated payment of $3.5 million received in August 2022.
• Potential to penetrate large disease populations including epilepsy, Parkinson’s disease, and spinal cord stimulation, with total addressable markets of $1+ billion, $5+ billion, and $10+ billion, respectively.
• Multi-billion market opportunity for combination devices; potential for technology adaptation and entry into AI and machine learning markets.
• Platform technology with licensing potential for applications in urinary incontinence, pain management, hypertension, depression, and other related neurological disorders.
• Ample capital resources to support upcoming commercial and development catalysts including the commercial launch of the Evo sEEG diagnostic line, and further development of OneRF and a thin-film-based SCS electrode system.
• Leadership with deep expertise in medical device technology, marketing, and business development; world-class board of directors; esteemed scientific and physician advisory boards.

NEUROONE® ANNOUNCES $3.5 MILLION ACCELERATED MILESTONE PAYMENT FROM ZIMMER BIOMET FOR EVO® SEEG ELECTRODE

Amendment provides Zimmer Biomet with 350,000 warrants with exercise price of $3.00 per share

EDEN PRAIRIE, Minn., Aug. 3, 2022 /PRNewswire/ — NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that the Company entered into an amendment to its Exclusive Development and Distribution Agreement with Zimmer Biomet, Inc. (“Zimmer”) that will provide the Company with a $3.5 million accelerated payment within 10 business days which relates to certain milestone payments.  In addition, Zimmer Biomet will receive a Warrant to purchase 350,000 shares of the Company’s common stock, with an exercise price of $3.00 per share.

Dave Rosa, Chief Executive Officer of NeuroOne, states, “I want to thank Zimmer for all their support to date and their confidence in our business, technology and future endeavors. This agreement accomplishes multiple objectives for NeuroOne, most importantly by providing additional capital to our balance sheet in the short-term without the need for a highly dilutive financing, and further reinforcing our ongoing partnership with Zimmer.”

Brian Hatcher, President of the Trauma, CMFT, Foot and Ankle Division of Zimmer said, “We look forward to continuing the relationship with NeuroOne as we advance our mission to alleviate pain and improve the quality of life for people around the world.” Under the Exclusive Development and Distribution Agreement signed by both parties in July 2020, Zimmer Biomet has exclusive global distribution rights to distribute the Company’s Cortical and sEEG diagnostic electrode technology.

NEWS

APR 27, 2023 04:00PM

NEUROONE REPORTS INDUCEMENT GRANT UNDER NASDAQ LISTING RULE 5635(C)(4)

MAR 16, 2023 07:30AM

NEUROONE® SUCCESSFULLY COMPLETES INITIAL ANIMAL IMPLANT OF NOVEL THIN FILM PADDLE LEAD FOR SPINAL CORD STIMULATION

MAR 09, 2023 09:00AM

NEUROONE® TO PARTICIPATE IN THE 35TH ANNUAL ROTH CONFERENCE

MAR 07, 2023 07:30AM

NEUROONE® AWARDED U.S. PATENT COVERING NOVEL AND PROPRIETARY THIN FILM ELECTRODE PLATFORM

FEB 14, 2023 04:00PM

NEUROONE® REPORTS FIRST QUARTER FISCAL YEAR 2023 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

FEB 09, 2023 09:00AM

NEUROONE® TO REPORT FIRST QUARTER FISCAL YEAR 2023 FINANCIAL RESULTS AND PROVIDE A CORPORATE UPDATE ON FEBRUARY 14

JAN 30, 2023 09:00AM

NEUROONE® ISSUES LETTER TO SHAREHOLDERS

DEC 22, 2022 09:00AM

NEUROONE® REPORTS FISCAL FOURTH QUARTER AND FULL FISCAL YEAR 2022 FINANCIAL RESULTS

DEC 13, 2022 04:00PM

NEUROONE® TO HOST FISCAL FOURTH QUARTER CORPORATE UPDATE

DEC 08, 2022 09:00AM

NEUROONE® TO REPORT FOURTH QUARTER AND FISCAL YEAR 2022 FINANCIAL RESULTS AND PROVIDE CORPORATE UPDATE ON DECEMBER 13

DEC 06, 2022 09:00AM

NEUROONE® SUCCESSFULLY COMPLETES FEASIBILITY STUDY WITH ITS ONERF™ ABLATION SYSTEM

NOV 30, 2022 09:00AM

NEUROONE® SHIPS INITIAL ZIMMER BIOMET ORDER FOR ITS EVO® SEEG SYSTEM FOR LESS THAN 30 DAY USE

NOV 22, 2022 09:00AM

NEUROONE® TO RING NASDAQ STOCK MARKET CLOSING BELL ON NOVEMBER 22

NOV 21, 2022 11:00AM

NEUROONE® CEO DAVE ROSA FEATURED ON FOX BUSINESS NETWORKS MORNINGS WITH MARIA

OCT 25, 2022 09:00AM

NEUROONE® RECEIVES FDA 510(K) CLEARANCE TO MARKET ITS EVO® SEEG SYSTEM FOR LESS THAN 30 DAY USE

SEP 22, 2022 09:00AM

NEUROONE REPORTS INDUCEMENT GRANTS UNDER NASDAQ LISTING RULE 5635(C)(4)

MANAGMENT

DAVE ROSA

President & Chief Executive Officer

Mr. Rosa is an entrepreneur with three decades of experience in the medical device industry spanning a variety of technologies and products. In addition to CEO roles with early-stage medical device companies, Mr. Rosa’s background also includes senior roles with C.R. Bard Inc., Boston Scientific Inc., and St. Jude Medical, where his responsibilities included marketing, product development and business development. He has been named as an inventor on multiple medical device patents, serves on seven corporate boards, and has raised $200M in the capital markets. Mr. Rosa holds an MBA from Duquesne University and a BS in Commerce and Engineering from Drexel University.

RON MCCLURG

Chief Financial Officer

Mr. McClurg has over 30 years of financial leadership experience with private and public companies. Prior to joining NeuroOne, Mr. McClurg was VP – Finance & Administration and Chief Financial Officer of Incisive Surgical, Inc., a privately-held medical device manufacturer, and Chief Financial Officer and Treasurer of Wavecrest Corporation, a privately-held manufacturer of electronic test instruments for the semiconductor industry. Mr. McClurg also served as Chief Financial Officer for several publicly-held companies, including Video Sentry Corporation, Insignia Systems, Inc., and Orthomet, Inc. Currently, he serves as a director for a privately held company. He began his career in public accounting with Ernst & Young, where he earned his CPA certificate. He holds a Bachelor of Business Administration degree in accounting from the University of Wisconsin – Eau Claire.

MARK CHRISTIANSON

Co-Founder, Business Development Director, Medical Sales Liaison

In excess of 15 years of executive sales, sales management, marketing, and project management experience with development stage companies. Prior to NeuroOne, Mr. Christianson held the positions of North American Sales Manager for Cortec Corporation, a manufacturer of specialty chemical products, and Regional Sales Manager for PMT Corporation, a leading manufacturer of products for neurosurgery, orthopedics and plastic surgery. He holds an accounting degree from Augsburg College.

STEVE MERTENS

Chief Technology Officer

Prior to joining NeuroOne, Mertens was Sr. Vice President of R&D and Operations at Nuvaira, a privately held lung denervation company developing minimally invasive products for obstructive lung diseases. Before that, Mertens was a Senior Vice President of Research and Development for Boston Scientific, where he guided a wide range of technologies through product development for the cardiology, electrophysiology, and peripheral vascular markets.

Mertens began his medical device career working in engineering, quality control, and manufacturing roles at SciMed Life Sciences. Mertens holds a Bachelor of Science degree in Chemical Engineering from the University of Minnesota and a master’s degree in Business Administration from the University of St. Thomas.

CAMILO DIAZ-BOTIA

Director of Electrode Development

Dr. Camilo Diaz-Botia is a highly experienced neural engineer whose work has focused on the development of technologies for bidirectional communication with the nervous system. He has authored and co-authored multiple peer reviewed scientific articles published in journals including Journal of Neural Engineering, Neuron, and Lab-on-a-Chip.

Most recently, Dr. Diaz-Botia worked for Neuralink where he led and mentored the process engineering team to deliver projects with unique microfabrication processes. Under his direction, the team built and designed novel processes for integration of thin film neural probes with brain machine interface systems.

Dr. Diaz-Botia earned a B.S. in Electrical Engineering from Universidad Nacional de Colombia and a Ph.D. in Bioengineering from the joint program at the University of California Berkeley and the University of California San Francisco. During his graduate studies, he conducted research on microfabricated thin film neural interfaces for chronic implants developing electrocorticography arrays with silicon carbide, a material suitable for long-term performance in harsh environments, and electrode arrays for minimally invasive subcortical recordings.

CHAD WILHELMY

Vice President of Quality Control and Regulatory Affairs

Chad Wilhelmy joined NeuroOne with 20 years of medical device experience developing, implementing, and leading quality management systems. Prior to joining NeuroOne, he held top leadership roles at HLT Medical as the Vice President of Quality and at Sunshine Heart as the Senior Director of Quality. He has driven quality strategies from early-stage development to commercial distribution with both the FDA and Notified Body. Chad earned a Bachelor of Science degree from the University of Wisconsin – Stout in Engineering Technology with an emphasis in Quality.

Sincerely,

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OUR NEW PROFILE IS:   (NASDAQ: VUZI)

__________

VUZIX IS A PIONEER IN WEARABLE COMPUTING, AUGMENTED REALITY, OPTICS AND DISPLAY ENGINES AND HAS BEEN DELIVERING SOLUTIONS TO CUSTOMERS FOR OVER 20 YEARS

VUZI IS SITTING WITH JUST OVER $73 MILLION IN CASH AS OF DECEMBER 31

VUZIX ACHIEVES RECORD SMART GLASSES SALES IN Q1 2023

FOR THE FULL YEAR ENDED DECEMBER 31, 2022, TOTAL REVENUES WERE $11.8 MILLION

BACK IN MARCH OF 2023, DAWSON JAMES SECURITIES ANALYST, JAMES MCILREE, REITERATED HIS $15.00 TARGET ON VUZI

CHECK OUT THE INVESTOR PRESENTATION HERE

*****BREAKING NEWS YESTERDAY*****

Vuzix Delivers Volume Smart Glasses Order to Tabbara Electronics.

Read the full news release here: https://t.co/dakeGlZoXU $vuzi #Technology #AR #TabbaraElectronics #MiddleEast @tabbarallc

— Vuzix (@Vuzix) April 26, 2023

_____________________

Hello Everyone,

We want you to take a look at a Tech company that already has a massive following and a lot of notoriety in the media on top of several other major catalysts.  This already has their foot in the door with several Fortune 100 companies and are sitting with over $70 Million in cash and generated almost $12 Million in revenue last year.  They also received a $15 Price Target which is over 400% above it’s current levels.

This is one that you will want to research right away!

Pull up Nasdaq: VUZI Immediately. 

This is a company that has been on a tare coming off of the CES, the worlds premiere electronics show.  They debuted their Ultralite AR Glasses.  Their have been a few positive articles from prominent publishers like the Wall Street Journal and Tech Times.  These are glasses that have ordinary-looking plastic frames with a tiny projector tucked in one stem and a tiny battery and Bluetooth radio in the other. It also has Vuzix’s waveguides which is a layer in the glasses that bends the projector’s light into your line of sight.

I know I laughed the first time I really heard of a Tesla.  The concept of an electric car sounded ridiculous and I didn’t think that anyone would really buy them. I also never thought that re-charging could never be made something that is practical and easy to do.  Now if you drive down a California highway it seems like every 7th or 8th car could be a Tesla.  They are everywhere.

I really don’t think it would be a far-fetched statement to say that some of the concepts that VUZI have rolled out and AR Glasses could be part of our everyday life in the near future.  There is a whole generation getting older that grew up with some of the advanced technology that we use today. They didn’t have to learn it as adults.  It was part of their upbringing.  This isn’t something that will be unique to AR.  I think it will impact all areas of technology.

The company itself has a lot going on.  Vuzix is a leading supplier of Smart Glasses and Augmented Reality (AR) technologies and products for the consumer and enterprise markets. They have offices in Rochester, NY, Oxford, UK, and Tokyo, Japan and were founded back in 1997.  The Company’s products include personal display and wearable computing devices that offer users a portable high-quality viewing experience, provide solutions for mobility, wearable displays and augmented reality. Vuzix holds 274 patents and patents pending and numerous IP licenses in the Video Eyewear field. Moviynt, an SAP Certified ERP SaaS logistics solution provider, is a Vuzix wholly owned subsidiary. The Company has won Consumer Electronics Show (or CES) awards for innovation for the years 2005 to 2023 and several wireless technology innovation awards among others.

Their AR wearable display devices are worn like eyeglasses or attach to a head worn mount. These devices typically include a wearable computer, cameras, and sensors that enable the user to view, record and interact with video and digital content, such as computer data, the Internet, enterprise data, social media or entertainment applications. Their wearable display products integrate micro-display technology with our advanced optics to produce compact high-resolution display engines, less than half an inch diagonally, which when viewed through our Smart Glasses and AR products create virtual images that appear comparable in size to that of a computer monitor or a large-screen television. This includes the representative forms such as augmented reality (AR), mixed reality (MR) and virtual reality (VR) and the areas interpolated among them. Extended reality (XR) is a term referring to all real-and-virtual combined environments. Their wearable display products cover the entire spectrum from “the complete real” to “the complete virtual” in the concept of reality–virtuality.

They believe that their waveguide optics and display engines offer a number of significant advantages over other wearable display solutions, including higher contrast, greater power efficiency, less weight, more compact size, and high brightness images for use outdoors. They also believe that our waveguide optics give them a substantial advantage over competitors’ optics, including other waveguides, because their solution allows them to produce optics that are fully transparent when off while also delivering the high brightness required for AR and enterprise Smart Glasses applications.

They  believe that key growth areas for us are the enterprise, medical, consumer electronics, OEM, defense and security markets. They are addressing most of these markets by developing and selling their own finished products and building a growing eco-system of software and services internally and with their value added resellers, or VARs, developers and end customers. Another potential channel to these markets they are developing includes supplying mass production of waveguide optics and display engines to select third parties to use in their products.

They believe that their waveguides and compact display engine technologies are a key differentiator for enabling next generation AR and Smart Glasses hardware for the enterprise and consumer segments because they will ultimately allow them to make HMDs nearly indistinguishable from regular eyeglasses.

They have developed their own intellectual property portfolio that includes patents, over 22 years of manufacturing know-how, software, proprietary processes, materials and equipment to create high performance waveguides, and near-eye display products. They believe our technology, intellectual property portfolio and position in the marketplace give them a leadership position in AR and Smart Glasses products and waveguide optics and display engine technology.

The best #VR and #metaverse #tech of #CES2023 featuring Vuzix Ultralite.

A super-slim and lightweight design for #AR glasses that pairs with your smartphone and brings notifications and more into view

More by @AceOfThumbs via @DigitalTrends here: https://t.co/4fFTvhHJ1f $vuzi

— Vuzix (@Vuzix) January 16, 2023

VUZI EXPLODED AT THE END OF DECEMBER  FROM BELOW IT’S CURRENT LEVELS TO OVER $6

VUZIX ACHIEVES RECORD SMART GLASSES SALES IN Q1 2023

– Preliminary Q1 2023 Revenue Has Topped $4 Million

ROCHESTER, N.Y., April 10, 2023 /PRNewswire/ — Vuzix® Corporation (NASDAQ: VUZI), (“Vuzix” or, the “Company”), a leading supplier of Smart Glasses and Augmented Reality (AR) technology and products, today announced that first quarter 2023 sales of AR smart glasses were at a record level, driven by use for enterprise and medical applications. As a result, the Company has also announced that preliminary revenue for its first fiscal quarter of 2023 has surpassed $4.0 million, more than 60% ahead of the prior year’s first quarter’s revenues of $2.5 million.

The Company’s preliminary and unaudited financial revenue results and the related comparison to the prior year’s period included in this release, are subject to the completion of the Company’s financial close and other procedures and finalization. Accordingly, actual financial results to be reflected in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, may differ from the preliminary and unaudited revenue results presented herein.

SALES PROGRESS

MEDICAL APPLICATIONS

Great to see companies like @amazon sharing their success using @Vuzix #smartglasses to perform world class maintenance and solve core and common business problems in the moment #innovation #logistics #manufacturing #maintenance #business $VUZI $AMZN https://t.co/6pnA682kIb pic.twitter.com/Ry4gM2r14Y

— Vuzix (@Vuzix) July 22, 2022

PRODUCTS

VUZI showcased a robust lineup of smart glasses at this year’s Consumer Electronics Show, held in Las Vegas, Nevada. In addition to displaying its new CES 2023 Innovation Awards winning Vuzix Ultralite™ AR smart glasses OEM design, which uses Vuzix’ industry leading waveguides and the latest microLED displays, Vuzix demonstrated its M-Series, Vuzix Blade 2™ and Vuzix Shield™ AR smart glasses.

Vuzix® Corporation’s innovative Vuzix Blade 2™ smart glasses (shown above) connect frontline workers with critical AR systems, enabling hands-free, heads-up access to data and remote expertise, all in a sleek, lightweight form factor.

Allowing you to keep your eyes protected with an ANSI Z87.1 certification while maintaining focus on your work. Ultrabright waveguide optics merge digital instructions onto real-world tasks, removing distractions and vision occlusion, ultimately reducing error rates and making your connected workforce more effective.

The World’s First Advanced Binocular Waveguide Built For Industrial Use. (Shown Below)Vuzix Shield™ is a revolutionary leap for enterprise AR smart glasses. Lightweight, stylish, prescription ready safety glasses and powerful 8-core CPU combine to deliver a singular wearable experience.

Connect to the metaverse accessing IT sensors, instructions, or live remote guidance, leaving your hands free. Scan codes with an advanced reader or wirelessly stream video from the field all enabled through voice or touch.

With the world’s first miniature uLED stereo displays, Vuzix Shield connects smart workforces with AR systems for optimized performance, safety and operational efficiency.

Using a Vuzix accessory adapter and a compatible infrared camera, including FLIR cameras, Vuzix M-Series AR smart glasses will allow visitors to see in the infrared spectrum, giving them a heads-up display of what’s normally hidden from view. Infrared video can also be broadcast over Zoom to enable team inspections.

Using Vuzix Blade 2 AR smart glasses, visitors will be put in charge of solving a real-life industrial challenge, the resetting of an electric power station, using on-glasses video and a set of work instructions.

Using Vuzix Shield AR smart glasses, visitors will be put in the role of a quality check inspector checking one of the most beautiful bikes ever, a real MV Agusta Superveloce 8001, to perform a scan for equipment recalls.

Using Teamviewer Frontline software running on Vuzix M400 AR smart glasses, visitors will be able to explore how major distribution centers drive efficiency improvements every day.

Finally, as part of its OEM offerings, Vuzix will be showcasing the 2023 CES award winning, sleek, AR smart glasses reference design called Vuzix Ultralite.

Offering fully customizable form factors, optics and more, Vuzix OEM solutions produce smart glasses and components that are miles ahead of the pack to support the worldwide adoption of AR.

“We keep expanding and improving the competitiveness of our smart glasses family of products. We enter 2023 with the strongest product lineup in our history, one that continues to attract an expanding number of blue chip customers across a wide range of industry verticals,” said Paul Travers, President and CEO of Vuzix.“We intend to remain focused on offering solutions that increase worker productivity, interactivity and safety while reducing errors and improving our carbon footprint.”

VUZIX ULTRALITE

AN OEM SMART GLASSES PLATFORM LIKE NO OTHER

The Vuzix Ultralite™ AR Smart Glasses Platform is a go-to-market ready, turnkey offering designed to fast track client AR solutions into production. Weighing in at a mere 38 grams, super power-efficient with up to 48 hours of run time on a single charge, and packing an impressive waveguide to display information from your phone hands-free to your eye, Vuzix Ultralite OEM platform is a blueprint for the world’s most fashion forward smart glasses.  

TRUSTED PROPRIETARY TECHNOLOGY FROM VUZIX

Advanced monocular waveguide optics, combined with our custom micro display engine, create a crisp, transparent image that can deliver all the important information on a user’s smartphone/watch, hands-free right before their eyes. Prescription ready with multiple sizes and an array of component combinations, the Vuzix Ultralite OEM platform makes available our extensive manufacturing capabilities and patent-protected leadership position in both waveguides and custom display engine solutions.

THE POWER TO DEPLOY YOUR AR SOLUTION AT SCALE

The Vuzix Ultralite OEM platform is designed to enable leading consumer technology firms to accelerate deployment of AR smart glasses solutions to the masses. Our manufacturing facility in Rochester NY is an ISO 9001:2015 facility that includes Class 6 and Class 7 clean room enclosures ensuring the highest levels of product quality and precision. All Vuzix OEM components are designed and manufactured in the USA, leveraging proprietary advancements in waveguide technology protected by our extensive IP portfolio. 

VUZIX ULTRALITE OEM PLATFORM BENEFITS

• Puts your smartphone’s alerts, messages, and custom applications content heads up in front of your vision.

• Get hands free access to important information, from language translation and closed captioning, to directions, to health and workout status, to messaging and much, much more.

• Designed to work hand to glove with both Android and iOS phones, Vuzix Ultralite is the reference design for the perfect smartphone accessory.

• Virtually endless configuration options around size, color, form factor and optical setup to set your solution apart.

• Vuzix is working with the world’s leading consumer electronic technology companies to bring lightweight, affordable smart glasses solutions to market.  

BACK IN MARCH OF 2023, DAWSON JAMES SECURITIES ANALYST, JAMES MCILREE, REITERATED HIS $15.00 TARGET ON VUZI

Here’s the thing. From Tuesday’s closing valuation, that provides VUZI with over 300+% potential upside.

Here’s a few key highlights from the report: 

• Commercial opportunities could be catalyzed by Apple’s long-awaited entry into the market with an AR/VR headset. Vuzix offers an ultralite smartglass system for the OEM market that utilizes the company’s proprietary waveguide solution and custom microdisplay engine. A consumer smartglass solution is being pursued by many of the major tech companies including Meta, Apple and Alphabet. We expect a robust market will emerge over the coming years and Vuzix is positioning itself to serve that space.
• In the defense market, the company has development deals with a handful of major defense contractors on waveguide-based products. Lead times can be extended, but once deployment begins production runs can be long and very profitable. We estimate typical production contracts could generate $10 to $15Mn over a multi-year time frame. Vuzix is also working with multiple customers on supplying waveguides for the consumer market. There is upside to our sales projections from these waveguide projects.
• The company has unique expertise in waveguide design and manufacturing and is expanding its waveguide capacity both in response to customer indications of interest and to make itself the number-one choice of waveguides in the OEM market for industrial and consumer use. This in-vest-ment is modest, a few Mn dollars, and will expand capacity, lower costs and enable a more robust feature set than the current product. We believe Vuzix can be one of the leading suppliers of waveguides and that this investment will enhance that capability. 
• Price Target Methodology. Our $15 price target values the company’s smart glasses and waveguide businesses at a significant discount to recent market transactions in the smart glasses space of $775M to $2B and $500M to $542M in the waveguide market.

Check out the full report here.

VUZIX CEO ADDRESSES SHAREHOLDERS AND ADVANCES BULLISH OUTLOOK FOR 2023

–  Strong revenue growth expected across core smart glasses products, OEM/Engineering services and SaaS software solutions

ROCHESTER, N.Y., April 19, 2023 /PRNewswire/ — Vuzix® Corporation (NASDAQ: VUZI), (“Vuzix” or, the “Company”), a leading supplier of Smart Glasses and Augmented Reality (AR) technology and products, today issued a shareholder letter from its President and Chief Executive Officer, Paul Travers. The letter, stated in its entirety below, provides an opening 2023 comment, a recap of 2022 achievements and developments, and then gets into more details about the success drivers regarding the Company’s 2023 growth initiatives and trajectory.

Dear Fellow Shareholders:

I want to share some of our recent Company highlights, outline the strength we are experiencing in general, and share our vision for the future as a leader in the wearable computing, augmented reality (AR) and smart glasses markets.

2023 will be a year of significant growth and strong revenues for Vuzix

In the years leading up to and including 2022, our revenues were primarily derived from our core smart glasses enterprise business. Today we now have revenue growth expectations from three contributing business sources at Vuzix, all revolving around our core smart glasses technology:

• Core smart glasses products
• OEM/Engineering services
• SaaS solutions for logistics and supply chain

Vuzix’ enterprise smart glasses business is now positioned to generate significant revenue growth in 2023. Our newly formed OEM design and manufacturing platform is seeing success and is expected to deliver new revenue growth in 2023, both in the form of engineering services and products. Our SaaS-based logistics solution company, which started generating incremental revenue and customer traction simultaneous with its acquisition last fall, will add to our sales total for the year. With this stronger portfolio of product offerings and services, Vuzix is well positioned to achieve substantial top-line revenue growth in 2023. We believe our first quarter represents a harbinger of the year’s strength with preliminary revenue in excess of $4Mn, as recently announced, rising more than 65% year-over-year versus 2022’s Q1 level, primarily on record sales of smart glasses as a result of enterprise customer growth, adoption and deeper rollouts in the period.

2023 is starting off strong and setting up to deliver strong annual sales

To recap, our first quarter of 2023 is off to a very strong start. We are bullish on our full-year prospects for 2023 with our potential for continuing record revenues from our collective product and OEM engineering services. Anticipated developments for 2023 include:

• increased deployments in warehousing and logistics;
• expanding healthcare deployments from existing ISVs and with multiple new customers;
• further expansion of our sales channels in specific new geographic regions;
• additional and larger engagements from defense firms that should evolve into longer-term production programs;
• signing of first agreements with potential OEM and white label firms for our waveguides and display engines;
• initial deployments of Ultralite-based product by Vuzix or third parties; and
• increased SaaS revenue from our Moviynt acquisition.

Conclusion

We significantly strengthened our infrastructure along with the breadth and competitiveness of our products and technologies in 2022 and, as a result, we are better positioned for success in 2023 and beyond. We are working across many market verticals — from warehousing and logistics, automotive, pharma and healthcare, to defense and consumer — to deliver industry leading smart glasses and engineering service solutions.

Many people and potential customers today are not yet fully aware of the value of our waveguide intellectual property and production capabilities, and the equally strong position we are working to create on the display engine side. For the broader markets to be successful, waveguide and display manufacturing in volume and at price points that can meet the market requirements critical for success, and Vuzix’ ongoing investments in these areas should uniquely position us to continue leading and delivering on this need. We feel we can honestly say that there are no competitors anywhere close to delivering what Vuzix can offer today, and what we expect to deliver in the near future.

I, and all of us at Vuzix, appreciate your interest, and I am confident 2023 will represent a year of solid progress for Vuzix.

Best regards,

Paul J. Travers

President and CEO

Vuzix Corporation

_____

VUZIX STRENGTHENS ITS GLOBAL SALES AND SUPPORT INFRASTRUCTURE WITH NEW OFFICES AND CORPORATE ENTITIES IN GERMANY AND JAPAN

 Regional cost-effective moves will boost customer service, accessibility, development and support

ROCHESTER, N.Y., April 24, 2023 /PRNewswire/ — Vuzix® Corporation (NASDAQ: VUZI), (“Vuzix” or, the “Company”), a leading supplier of Smart Glasses and Augmented Reality (AR) technology and products, today announced two international infrastructure developments that will allow the Company to better serve existing partners and customers, as well as develop and support new relationships. New offices and corporate entities have recently been established in Germany and Japan, two countries geographically situated to address significant local and regional market opportunities. In addition to improving sales and customer support in these areas, these moves will also reduce overall costs due to the elimination of capital taxes based on the Vuzix parent corporate entity.

To expand its presence in Europe and signal a clear strategic decision to the Company’s European customers and partners, Vuzix has established an EU-based office in Munich, Germany. Munich is a preferred location for the EU offices of many global IT companies, as well as boasting a strong local technology community. The new office, established as Vuzix Europe GmbH*, a 100% wholly-owned subsidiary of Vuzix, will serve not only the EU, but also the Middle East and Africa and will even operate globally in some sales and marketing functions while the Company expands its global footprint.

In Japan, Vuzix has converted its legal designation from a branch to a KK** corporate entity, a 100% wholly-owned subsidiary of Vuzix, an action that will optimize the Company’s tax structure and better allow it to scale its organization under Japanese laws. Additionally, Vuzix has opened a new office in Kyoto, a cultural and geographic hub in Japan which offers faster and more expansive local and international shipping capabilities than Tokyo. As many of Vuzix’ larger Japanese customers are located in the western regions of Japan, the new office in Kyoto will be better positioned to sell to and support these customers.

“These new offices and newly established corporate entities are all about increasing Vuzix’ ability to better serve our customers and partners and show our commitment to these strategic growing markets. We feel this enhances our distinct competitive advantage in these markets with local staffing and fuller country compliance now with effectively local entities involved in and specializing in enterprise AR smart glasses,” said Paul Travers, President and CEO of Vuzix. “Having a stronger regional presence in these key locales provides the customer with increased confidence of the entity they are transacting with and greatly improves our ability to share an enhanced local knowledge, improves customer visibility, quickens our speed to act, and helps streamline our legal and business processes to more cost effectively and faster support and address both existing and new business opportunities.”

*GmbH is an abbreviation of the German term “Gesellschaft mit beschränkter Haftung,” which means “company with limited liability”.

**KK is an abbreviation of the Japanese term “Kabushiki Kaisha,” the most common and recognized type of business entity defined under Japanese law.

VUZIX RECEIVES OEM PURCHASE ORDERS FROM MULTIPLE DEFENSE AND COMMERCIAL CUSTOMERS

ROCHESTER, N.Y., Jan. 10, 2023 /PRNewswire/ — Vuzix® Corporation (NASDAQ: VUZI), (“Vuzix” or, the “Company”), a leading supplier of Smart Glasses and Augmented Reality (AR) technology and products, is pleased to announce the receipt of multiple OEM purchase orders for engineering services and products from three previously undisclosed defense firms and one previously undisclosed commercial customer. These orders, which were all received during the second half of 2022 and partially or fully shipped against before year end, are expected to expand in size over time to the extent each of these programs progresses. A brief description of each of these firms, the names of which cannot be disclosed at this stage of development, and the intended use cases for are as follows.

A multinational electronics contract manufacturer has placed multiple orders for Vuzix waveguides and displays to support its development and manufacture of unique vision-based AR glasses.

A US-based leader in technologically advanced and intelligent solutions for the global aerospace and defense industry has given Vuzix an engineering services contract to support the development of a lightweight heads-up display (HUD) replacement for technologies previously supplied by a China-based company. This firm, a top 10 defense contractor, is the incumbent supplier for several existing programs and has turned to Vuzix as a US-based manufacturer of waveguide and display technologies.

A US-based supplier of protective armor and head systems, as well as innovative power supply and management solutions for military and tactical operators worldwide, has placed an order for Vuzix hardware technologies that will support their efforts to design several prototype display systems for the US Navy. Naval teams are currently using ruggedized Android phones but want to move the display to the helmet using Vuzix display technology. This customer plans to deliver its prototypes to the US Navy in pursuit of a design selection that, if successful, could result in volume production contracts over the next several years.

A US-based global leader in personal protection and situational awareness solutions for defense forces, emergency responders, and industrial personnel, has placed an order for Vuzix waveguides and projectors with the objective of adding smart capabilities to their helmet solutions via inclusion of a HUD.

“Our OEM business has continued to steadily expand in 2022 as more and more defense, consumer and enterprise firms are turning to Vuzix for its advanced low-cost waveguide and display solutions, solutions that are designed and manufactured in the United States. With some of these defense firms, we are already discussing much larger development and supply contracts for 2023,” said Paul Travers, President and Chief Executive Officer at Vuzix. “These new relationships further demonstrate the emerging presence of our advanced technologies in next generation system designs.”

NEWS

Apr 24, 2023 9:05am EDT

VUZIX STRENGTHENS ITS GLOBAL SALES AND SUPPORT INFRASTRUCTURE WITH NEW OFFICES AND CORPORATE ENTITIES IN GERMANY AND JAPAN 

Apr 19, 2023 9:42am EDT

VUZIX CEO ADDRESSES SHAREHOLDERS AND ADVANCES BULLISH OUTLOOK FOR 2023 

Apr 12, 2023 9:01am EDT

VUZIX RECEIVES VOLUME FOLLOW-ON SMART GLASSES ORDER FROM ACURAFLOW TO SUPPLY PHARMACEUTICAL CUSTOMER 

Apr 10, 2023 8:52am EDT

VUZIX ACHIEVES RECORD SMART GLASSES SALES IN Q1 2023 

Apr 05, 2023 9:00am EDT

GLOBAL HEALTH TECHNOLOGY PLATFORM PROVIDER PROXIMIE COMMENCES ROLLOUT OF PXLENS USING VUZIX M4000™ SMART GLASSES 

Mar 27, 2023 8:45am EDT

VUZIX SMART GLASSES SUPPORT NEW PARTNERSHIP DESIGNED TO SOLVE GLOBAL HEALTH WORKFORCE SHORTAGES 

Mar 09, 2023 10:50am EST

VUZIX SIGNS DISTRIBUTION AGREEMENT WITH MACE VIRTUAL LABS AND RECEIVES SUBSTANTIAL INITIAL VOLUME SMART GLASSES ORDER 

Mar 06, 2023 3:00pm EST

VUZIX TO PARTICIPATE IN TWO FINANCIAL CONFERENCES IN MARCH 

Mar 01, 2023 4:05pm EST

VUZIX REPORTS 4Q AND FULL YEAR 2022 RESULTS 

Feb 23, 2023 3:35pm EST

VUZIX SCHEDULES CONFERENCE CALL TO DISCUSS FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS AND BUSINESS UPDATE

Feb 22, 2023 11:05am EST

VUZIX ANNOUNCES ANDROID 11 SUPPORT FOR ITS LATEST PORTFOLIO OF ENTERPRISE SMART GLASSES 

Feb 16, 2023 7:30am EST

VUZIX ADVANCES THE VUZIX ULTRALITE™ OEM PLATFORM TO BETTER FACILITATE VISUAL GPT AND OTHER AI FUNCTIONS 

Feb 09, 2023 1:00pm EST

VUZIX ENTERS FORMAL RESELLER RELATIONSHIP WITH OPTAC-X 

Feb 07, 2023 8:15am EST

VUZIX SMART GLASSES HAVE NOW SUPPORTED 40,000 VIRTUAL SESSIONS USING THE RODS&CONES REMOTE ASSISTANCE SERVICE FOR THE OPERATING ROOM 

Jan 31, 2023 7:00am EST

GLOBAL AEROSPACE CUSTOMER EXPANDS DEPLOYMENT OF VUZIX’ SAP-CERTIFIED WAREHOUSE SOLUTION 

Jan 25, 2023 8:15am EST

TELECOM CUSTOMER DEMAND FOR VUZIX SMART GLASSES RUNNING ON 4G AND 5G NETWORKS CONTINUES TO STEADILY EXPAND 

Jan 23, 2023 8:30am EST

OX COMMENCES DEPLOYMENT OF VUZIX SMART GLASSES AT ONE OF THE WORLD’S LARGEST LOGISTICS PLATFORM PROVIDERS 

Jan 17, 2023 8:30am EST

FORTUNE 50 GLOBAL RETAILER CONTINUES TO EXPAND ITS USE OF VUZIX SMART GLASSES TO SUPPORT ITS WAREHOUSING AND LOGISTICS OPERATIONS 

Jan 10, 2023 8:30am EST

VUZIX RECEIVES OEM PURCHASE ORDERS FROM MULTIPLE DEFENSE AND COMMERCIAL CUSTOMERS 

Jan 06, 2023 9:00am EST

VUZIX BLADE POWERS XANDER’S REAL-TIME CAPTIONING XANDERGLASSES FOR THE DEAF AND HARD OF HEARING

MANAGEMENT 

PAUL J. TRAVERS

CEO, President and Director

Paul Travers is the founder of Vuzix and has served as our President and Chief Executive Officer since 1997 and as a member of our Board of Directors since November 1997. Prior to the formation of Vuzix, Mr. Travers founded both e-Tek Labs, Inc. and Forte Technologies Inc. He has been a driving force behind the development of our products. With more than 30 years’ experience in the consumer electronics field, and 26 years’ experience in the virtual reality and virtual display fields, he is a nationally recognized industry expert. He holds an Associate degree in engineering science from Canton, ATC and a Bachelor of Science degree in electrical and computer engineering from Clarkson University.

GRANT RUSSELL

CFO, Executive Vice President, Treasurer and Director

Grant Russell has served as our Chief Financial Officer and Executive Vice President since 2000 and as a member of our Board of Directors since April 2009. From 1997 to 2004, Mr. Russell developed and subsequently sold a successful software firm and a new concept computer store and cyber café. In 1984, he co-founded Advanced Gravis Computer (Gravis), which, under his leadership as President, grew to become the world’s largest PC and Macintosh joystick manufacturer with sales of $44 million worldwide and 220 employees. Gravis was listed on NASDAQ and the Toronto Stock Exchange. In September 1996 it was acquired by a US-based Fortune 100 company via a successful public tender offer. Mr. Russell holds a Bachelor of Commerce degree in finance from the University of British Columbia and is both a US Certified Public Accountant and a Canadian Chartered Professional Accountant.

PETE JAMESON

COO

Pete Jameson was named Chief Operating Officer (COO) of Vuzix in January 2022, having served as General Manager since joining the company in January 2021. Mr. Jameson brings a wealth of operating experience to his new position. He previously served as COO of Osterhout Design Group (ODG), a leading wearable technology company that developed and manufactured mobile, self-contained and lightweight head-worn mixed reality smart glasses with photo-realistic imagery. Prior to ODG, Mr. Jameson was a 20-year executive at Eastman Kodak where he was a founding leader of Kodak’s multi-billion-dollar Digital Camera Business including General Manager and VP of the Digital SLR and Professional Digital Capture Group that created the world’s first digital SLR cameras, General Manager of Kodak’s Commercial Imaging Business in Europe, Africa and the Middle East and General Manager and VP of Kodak’s Digital Devices Group. He holds a Bachelor of Science Electrical Engineering degree from Union College and a Master of Business Administration degree from the University of Rochester Simon School of Business.

ERIC BLACK

General Counsel

Eric Black was named General Counsel of Vuzix in March 2022. Mr. Black brings a wealth of legal experience to his new position. While serving as in-house for other private and public technology companies, Mr. Black developed extensive experience in supporting business development and operational optimization by developing processes/workflows, negotiating complex contracts, advising on mergers and acquisitions, and informing business strategies that strengthen compliance and facilitate consistent growth. Mr. Black was previously named one of Rochester’s “Forty Under 40” by the Rochester Business Journal in 2006 and one of Rochester’s Top Counsel by the Rochester Daily Record in 2019. He holds a Bachelor of Economics degree from the University of Rochester and a Doctor of Jurisprudence degree from the University of Virginia School of Law.

SHANE PORZIO

Vice President Engineering

Shane Porzio has been with the Company for more than ten years and has more than 13 years of experience in architecture of systems and designs for hardware and software. His previous employment was at Lockheed Martin where he served as a Hardware Engineer. Mr. Porzio has BS in Computer Engineering Technology from Rochester Institute of Technology and his MS in Computer Science from Rochester Institute of Technology.

BILL BELTZ

Vice President of Global Sales

Bill Beltz brings a wealth of general management and sales experience to his new position. Prior to joining Vuzix, he served as Vice President of Sales at Snap One, a leading manufacturer and distributor of smart living technology. Prior to Snap One, he held sales and management positions of increasing responsibility at both NCR Corporation, a Fortune 500 software, consulting and technology company providing professional services and electronic products, and Radiant Systems, a provider of technology to the hospitality and retail industries that was subsequently acquired by NCR Corporation.

Sincerely,

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OUR NEW PROFILE IS:    NASDAQ: CTXR 

“MINO-WRAP” COULD REVOLUTIONIZE $400 MILLION POST-MASTECTOMY INFECTION PREVENTION MARKET

$41.7 MILLION IN CASH AND CASH EQUIVALENTS AS OF SEPTEMBER 30, 2022

MINO-LOK® PHASE 3 TRIAL CLOSER TO COMPLETION WITH 169 PATIENTS RECRUITED, 72 FAILURE EVENTS AND 17 PATIENTS IN ACTIVE TREATMENT OR PENDING DATA REVIEW

DOWNLOAD THE INVESTOR PRESENTATION HERE

DOWNLOADS THE FACT SHEET HERE

_______________________________

Hello Everyone,

We have another exciting profile for Tuesday’s session.  This is a company that we have put on you’re radar several times and is up since we last covered it in March.  

Pull up CTXR Immediately.

There is no denying that 2023 has been a good year so far for CTXR.  The turnaround started back in late December after it hit low’s and it has been climbing slow and steady ever since.  Historically CTXR has made some big multi-week moves and the evidence is right on the chart.

Right now this one is trending green until something gets in it’s way.

They are a late-stage biopharmaceutical company focused on the development and commercialization of first-in-class critical care products, with a diversified pipeline of five active programs. Three of its pipeline candidates would be the first and only prescription treatments in their indications if approved by the FDA. The Company has two late-stage product candidates, Mino- Lok®, an antibiotic lock solution to salvage infected central venous catheters (CVCs) of patients with catheter-related bloodstream infections (CRBSIs), which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and I/ONTAK (E7777), a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma (CTCL), which has completed its Phase 3 trial and is on track for submission of a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) in the second half of 2022. Mino-Lok® was granted Fast Track designation by the FDA. I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). Citius has announced its intention to spinoff I/ONTAK into standalone oncology-focused publicly traded company. During the second quarter of 2022, Citius initiated a Phase 2b trial of Halo-Lido, potentially the first and only FDA-approved prescription treatment for hemorrhoids; patient enrollment in the trial is expected to be completed by the end of 2022. Citius has two additional pipeline assets in pre-clinical devleopment: a novel proprietary mesenchymal stem cell (i-MSC) treatment for acute respiratory conditions, and Mino-Wrap, for the prevention of infection in tissue expanders and breast implants post mastectomy.

There are several catalysts in play right now that we need to look at:

ANALYST TARGET:

Dawson James Analyst Jason Kolberts’ $10.00 target could mean potential upside of 1,198% for Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) right after bouncing off its 52-week low of $.77 cents on 12/30/22 according to Barchart.com’s price history.^(32)(33)

ACTIVE CHART:

Since bottoming out and hitting its 52-week low of $.77 cents on 12/30/22, shares of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) have climbed to $1.13 for a solid 46.75% move in less than 10 days.⁽³³⁾

FDA CONFIRMATION:

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) has reported that the FDA confirmed Prescription Drug User Fee Act (PDUFA) target action date of July 28, 2023.⁽³⁵⁾

PHASE 3 TRIAL:

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) completed Pivotal Phase 3 trial of I/ONTAK (E7777) and submitted biologics license application (BLA) to the U.S. Food and Drug Administration (FDA).⁽³⁵⁾

BIOTECH CLUSTER WITH 70 NEW FDA APPROVALS:

The company is headquartered in a hotbed and breeding ground for successful Biotechs, which were responsible for a staggering 70 new FDA dr-ug approvals between 2020 and 2021.⁽⁴⁰⁾

ACCELERATED ADVANCEMENT:

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) expanded and accelerated its Phase 3 Mino-Lok trial to additional sites outside the United States. If approved, Mino-Lok would be the first-and-only antibiotic lock solution FDA-approved to salvage infected central venous catheters (CVCs) causing catheter-related bloodstream infections (CRBSIs).⁽³⁵⁾

CLINICAL COLLABORATION:

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) initiated a clinical collaboration with the University of Pittsburgh to evaluate regulatory T-cell (T-reg) depletion with I/ONTAK (E7777) in combination with pembrolizumab in recurrent or metastatic solid cancer tumors in a Phase 1 investigator-initiated trial, with first patient enrolled in November 2022.⁽³⁷⁾

Citius Pharmaceuticals, Inc. Reports Fiscal Full Year 2022 Financial Results and Provides #BusinessUpdate.

Read the full news release here: https://t.co/asCweu8PSs $CTXR pic.twitter.com/7CpaYjpGuv

— Citius Pharma (@CitiusPharma) December 23, 2022

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) Gets $10.00 Target From Dawson James Analyst Jason Kolberts.

Jason Kolberts is no stranger to the biotech and pharmaceutical industries.

He’s actually the Director of Research at Dawson James Securities, Inc.

And for those who don’t know, Dawson James is a full-service boutique investment banking firm focused on emerging growth companies since 2004 and committed to helping clients navigate the healthcare, biotechnology and technology markets. ⁽³⁸⁾

Jason Kolberts’ career began as a chemist in the pharmaceutical industry and evolved into a product and marketing manager with Schering-Plough in Japan. Upon returning from Japan, Jason joined Salomon Smith Barney, as a research associate which has now evolved into a 20-year career on Wall Street as a leader in the Healthcare space.⁽³⁸⁾

Kolberts’ coverage expands across multiple therapeutic areas in biotechnology, specialty pharmaceuticals, and medical devices. As an analyst Jason has developed a high level of expertise in oncology, virology and cell-based medicine such as CAR (Chimeric Antigen Receptor)-T cells and regenerative medicine (stem cells).⁽³⁸⁾

Prior to joining Dawson James, Mr. Kolbert spent the prior year as a senior biotechnology analyst at HC Wainwright and spent the previous seven years at the Maxim group, where he was an Executive Managing Director and the Head of Healthcare Research at the firm. During this period Jason and his team covered 80 names across the healthcare vertical. Jason’s Wall Street career began with seven years at Citi Group followed by several years on the buy side as a portfolio manager with the Susquehanna International Group.⁽³⁸⁾

One company that seems to have caught the eye of Jason Kolbert is Citius Pharmaceuticals, Inc. (Nasdaq: CTXR).

Mr. Kolbert has a $10.00 target on Citius Pharmaceuticals, Inc. (Nasdaq: CTXR).⁽³²⁾

This could mean a potential upside of 1,198% for Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) after a recent bounce off its 52-week low of $.77 cents on 12/30/22 according to Barchart.com’s price history.⁽³³⁾

Listen. Nothing is certain. But look at the Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) weekly chart above and do a little technical analysis using StockCharts.com. You can see the following moving averages:⁽³⁹⁾

Weekly average price is: $1.12 (as of 1/13/23)

50-day moving average at $1.18

200-day moving average at $1.28

20-day exponential moving average $1.07 (first line of resistance)

Shares of (CTXR) just trended above its first line of potential resistance at the $1.07 – $1.12 range(39). If (CTXR) is able to push through its 50-day moving average of $1.18… the next line of potential resistance could be its 200-day moving average at $1.28, which, if reached, would represent a potential 28% move as of 1/13/23’s opening price of $1.00.^(38)(33) A move back to the 200-day moving average is not certain, but the potential should be noted.

How would that move be possible?

You see, shares of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) could be at the beginning of what’s called a “Descending Triangle Breakout Strategy.”⁽³⁹⁾

…And by definition, the “Descending Triangle Breakout Strategy” as the name suggests, involves the anticipation of a breakout from the descending triangle pattern. ⁽⁴¹⁾

The basic premise of using this strategy is to look at volume once you’ve identified the pattern. You can typically observe that volume begins to diminish toward the end of the descending triangle pattern formation. ⁽⁴¹⁾

After bottoming out and hitting its 52-week low of $.77 cents on 12/30/22, shares of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) have climbed to $1.13 for a solid 46.75% move in less than 10 days.⁽³³⁾

Could this be the beginning of a much larger move?

Shares of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) would need to climb over 1,198% to reach the $10.00 target set by Dawson James Analyst, Jason Kolberts, from that 52-week low.⁽³²⁾

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) Has Built a Diversified Pipeline of Therapeutics with a Multi-Billion-Dollar Total Addressable Market.⁽⁴³⁾

Non-Hodgkin’s Lymphoma is one of the deadliest forms of cancer. 

Targeting your body’s germ-fighting immune system, it invades your body’s lymph nodes. Left unchecked, it can kill more than 1-in-3 of those diagnosed, with over a half-million new cases each year.

But one company could be set to change all that…

Flying well under the radar, Citius Pharmaceuticals (NSDQ: CTXR) has quietly acquired the rights to the experimental compound “E-7777,” ⁽²⁷⁾ a direct improvement to a previously FDA-approved medication that directly attacks infected cancer cells inside the human body.

And this new cancer-fighting remedy could be mere months away from its own approval. If and when it hits the market, this new treatment could provide a whole new proven alternative to the harsh side effects of chemotherapy or aggressive radiation treatment.

Directly targeting and attacking infected cells, E-7777 could transform the $5.4 Billion market for Non-Hodgkin’s Lymphoma treatment.

The best part of this whole story? This is just one of several potentially game-changing new therapies in the company’s pipeline …

CITIUS PHARMACEUTICALS, INC. IS A BIOPHARMA POWERHOUSE HIDING IN PLAIN SIGHT

Citius Pharmaceuticals United States NASDAQ: (CTXR) is what’s called a “late-stage biopharmaceutical” company, where a highly-experienced management team purchases rights to the most promising new therapies and then either brings them to market or licenses rights to bigger pharma companies like Pfizer or Johnson & Johnson.

It should go without saying that “late-stage” development is the most difficult, most expensive part of the process for any new kind of treatment. Because even after years of investment, research and development, some 2 out of 5 drugs still fail to secure final FDA approval.⁽³⁰⁾

But with a “Dream Team” of top industry insiders, Citius is turning the odds in their favor—with two treatments now in Phase 3, and both looking like they will pass.

In addition to E-7777, it’s currently advancing three proprietary product candidates in total:⁽¹²⁾

• Mino-Lok has advanced to Phase 3 clinical studies.
• CITI-101 (Mino-Wrap) is a malleable, bio-absorbable film impregnated with minocycline and rifampin. It is designed to reduce infections associated with the use of breast tissue expanders (TE) used in breast reconstruction surgeries following mastectomies.
• CITI-002 is being developed to provide anti-inflammatory and anesthetic relief to persons suffering from hemorrhoids.

We’re going to focus primarily on Mino-Lok here, since it’s Citius Pharmaceuticals’ most promising (and most immediate) potential revenue source …

MINO-LOK’S PHASE 3 CLEARANCE COULD BE THE KEY TO COMMANDING A $1.5 BILLION ² MARKET:

Mino-Lok is an antibiotic designed to treat patients with catheter-related bloodstream infections (CRBSIs). At present, these infections are treated by removing the catheter and prescribing antibiotics.

This is a costly medical process with potential complications. In fact, studies show that removal and reinsertion of CVCs have a 15% to 20% complication rate, including pneumothorax, misplacement, and arterial puncture. ⁽⁴⁾

Mino-Lok allows doctors to treat the infection without needing to remove the catheter, avoiding both costs and complications.

North America is projected to account for a major share of the global catheter-related bloodstream infections market during the forecast period due to well-established health care infrastructure. Europe is anticipated to be the second largest market from 2020 to 2030. ⁽³¹⁾

This market has very little, if any, competition

But here’s the biggest catalyst for Citrus, the global catheter-related bloodstream infections market is highly consolidated due to the presence of a small number of key players – which means at this time there is very little in the way of competition. ⁽³¹⁾

Currently, in Phase 3 pivotal trials, it could be approved in a matter of months … giving Citrus a massive leg up on any competition.

According to CEO Myron Holubiak: ⁽¹⁴⁾

“Data from the Mino-Lok® (M-L) Phase 3 program was reviewed by our independent Data Monitoring Committee (DMC) for safety and efficacy and found to be progressing as planned with no recommended changes to trial design.”

MINO-LOK HAS REPORTEDLY PERFORMED WELL TO DATE: ⁽¹⁸⁾

• Mino-Lok is the first and only therapy under investigation to salvage infected CVCs. In a Phase 2b trial, the Mino-Lok product demonstrated a 100% efficacy rate in salvaging colonized CVCs.
• Mino-Lok had no significant adverse events compared to an 18% serious adverse event rate when infected CVCs were removed and replaced.
• FDA Fast Track with QIDP designation and patent protection until June 2024. Formulation patent protection until November 2036. Currently in a Phase 3 pivotal superiority trial. ⁽¹⁴⁾

MEANWHILE, CITIUS’ “MINO-WRAP” COULD REVOLUTIONIZE $400 MILLION
POST-MASTECTOMY INFECTION PREVENTION MARKET

Citius’ Mino-Wrap could help reduce post-operative infections associated with surgical implants. Its gel-containing film is used primarily to wrap the tissue expander used in breast reconstructive surgeries.

As also noted by CEO Holubiak: ⁽¹⁴⁾

“We believe that this serious condition impacts about 100,000 women in the U.S. and many more in the rest of the world. Mino-Wrap is a bio-absorbable, antimicrobial semi-solid film that is wrapped around a tissue expander and placed in the surgical pocket following a mastectomy to prevent post-surgical infections. Once implanted, Mino-Wrap slowly dissolves in situ for a specified period of time, providing extended protection against infection.”

PROGRAM HIGHLIGHTS ⁽¹⁹⁾

• Potential to be first and only FDA-approved product to prevent infections associated with post-mastectomy breast implants
• Currently in preclinical development
• Development in partnership with The University of Texas MD Anderson Cancer Center and support from medical thought leaders

Get Instant Access to Investor Materials 

OFFERING RELIEF IN AN $80 MILLION HEMORRHOIDS MARKET

Shockingly, there are no FDA-approved prescription products for hemorrhoids at the moment.⁽¹⁶⁾

However, that could soon change with Citius’ halobetasol and lidocaine formulations.

Hemorrhoids are an uncomfortable and often recurring condition. However, despite the numerous prescriptions and over the counter (OTC) products commonly used to treat hemorrhoids, none possess the necessary safety and efficacy data generated from rigorously conducted clinical trials.

Citius believes its halobetasol-lidocaine product could one day become that go-to treatment for physicians wanting to provide patients with a therapy demonstrating safety and efficacy.⁽¹⁶⁾

PROGRAM HIGHLIGHTS: ⁽²⁰⁾

• There are no FDA-approved prescription products on the market for hemorrhoids
• Citius’ halobetasol and lidocaine formulation could become the first FDA-approved prescription product to treat hemorrhoids in the United States
• According to IMS, over 25 million units of topical combination prescription products for hemorrhoids are sold in the US

CITIUS PHARMACEUTICALS COULD EVEN HELP TREAT ARDS, TOO

• There are about three million cases of Acute Respiratory Distress Syndrome (ARDS) globally, with approximately 200,000 instances just in the U.S.⁽¹⁷⁾
• The health crisis significantly added to the amount of ARDS cases, with death rates among patients on ventilators as high as 50%.⁽¹⁷⁾

• Worse, at the moment, there are no approved treatments for ARDS.⁽¹⁷⁾

According to Citius CEO Holubiak:

“Currently, there is no FDA-approved drug therapy for ARDS. We plan to submit an IND to the FDA and initiate our Phase 1 study by the end of the second quarter of 2022. Our first-in-human clinical trial is entitled “i-MSCs in Subjects with Acute Respiratory Distress Syndrome (ARDS) Due to [the health predicament]: i-MARCO.” Following the completion of a multi-center Phase 1 pilot study, we would expect to proceed on to a double-blinded, randomized Phase 2/3 trial to demonstrate the safety, efficacy, and multimodal healing capabilities of our i-MSCs in patients with moderate to severe ARDS due to [the health predicament].” ⁽¹⁴⁾

PROGRAM HIGHLIGHTS: ⁽²¹⁾

• Novel stem cell therapy for the treatment of acute inflammatory respiratory disorders including acute respiratory distress syndrome (ARDS)
• i-MSCs derived from induced pluripotent stem cell reprogrammed using proprietary mRNA process
• No FDA-approved treatment for ARDS exists today
• Preclinical activities are underway

Get Instant Access to Investor Materials 

$7.2 BILLION IN POTENTIAL MARKET DISRUPTION

As you’ve seen today, some of the treatments in Citius Pharmaceuticals’ portfolio go far beyond the definition of “Cutting Edge” …

Mino-Lock could potentially erase the need to operate on those suffering from Catheter-Related Bloodstream Infections (CRBIs), revolutionizing treatment of a $1.5 Billion medical problem overnight. E-7777 could offer a powerful new alternative to those suffering from Non-Hodgkin’s Lymphoma.

Combined with a full pipeline of other treatments, Citius Pharmaceuticals could be sitting on top of $5.5 Billion in cumulative pharmaceutical market disruption…

With a full year’s “cash runway” (through December 2023)(43)left to complete critical Research & Development, along with the outrageous profit potential if even one of these treatments makes it to market, Citius Pharmaceuticals (NSDQ:CTXR) is a company that should definitely be on your radar.

CITIUS PHARMACEUTICALS, INC. (NASDAQ: CTXR) IS HEADQUARTERED IN ONE OF THE COUNTRY’S HOTTEST BREEDING GROUNDS FOR FOR SUCCESSFUL BIOTECH’S

“This was the first year that Citius qualified for the program, and we are delighted to have been selected to participate in New Jersey’s NOL Program. As a pre-revenue business, this program allows us to convert certain losses from operations into tangible working capital today, supporting our ongoing research and development efforts. We are thankful to the NJ Economic Development Authority for aiding our efforts in our initial year of participation. This non-dilutive funding will provide added cash runway as we advance a late-Phase 3 trial for Mino-Lok®, a Phase 2b trial for Halo-Lido, and a recently submitted biologics license application (BLA) for I/ONTAK,” stated Jaime Bartushak, Chief Financial Officer of Citius.⁽⁴⁵⁾

New Jersey’s biotechnology cluster has grown from a mere 30 companies in the early 1990s to approximately 3,200 establishments in the state today. 46 of those firms are responsible for a staggering 70 new FDA drug approvals between 2020 and 2021, according to the trade association BioNJ.⁽⁴⁰⁾

And several sources indicate that despite recent IPO and capital market challenges, the biotech cluster’s ascension continues.⁽⁴⁰⁾

Debbie Hart, president and CEO of BioNJ, says of the overall US/global biotech community: “The science is advancing by leaps and bounds, and it’s creating lots of opportunities, new companies, and new advances in therapies and treatments.”⁽⁴⁰⁾

“When you look at what happened during the global pandemic – how the industry can really save the world – [it’s] not an understatement. It just speaks to ability and the science.”⁽⁴⁰⁾ 

New Jersey’s specific biotech juggernaut partly stems from a constellation of cutting-edge advances in cell and gene therapy operating in tandem with a Garden State life sciences ecosystem replete with contract manufacturing and clinical research organizations, as well as specialized accountants, attorneys, and other professionals who serve the industry.⁽⁴⁰⁾

Such a network is particularly important for the biotechnology community given the challenges it faces.⁽⁴⁰⁾

Dean J. Paranicas, president and CEO of the HealthCare Institute of New Jersey (HINJ), details the overall “high-risk profile” for the biopharmaceutical industry: “There’s that challenge of having enough capital to develop your product, being able to get it through the regulatory cycle, and then commercializing [it] and getting it into the marketplace.”⁽⁴⁰⁾

Paranicas additionally explains that New Jersey firms have beneficial opportunities to coordinate with the state’s research institutions as well as with more established companies located here.⁽⁴⁰⁾

Also helping to lubricate the state’s growing industry is New Jersey’s proximity to Wall Street and, separately, a time-zone advantage, which facilitates business communication with locales as diverse as, say, California and the United Kingdom.⁽⁴⁰⁾

In November of 2022, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced it had secured $3.6 million through New Jersey Economic Development Program.⁽⁴⁵⁾

CITIUS PHARMACEUTICALS, INC. (NASDAQ: CTXR) ANNOUNCES A CLINICAL COLLABORATION WITH THE UNIVERSITY OF PITTSBURGH.⁽⁴⁶⁾

The study consists of two parts. Part I is a dose escalation study of four cohorts (3,6,9,12 mcg of I/ONTAK) and is expected to enroll 18-30 patients. Part II is a dose expansion study of approximately 40 patients to evaluate the safety and tolerability of the recommended combination dose of I/ONTAK and pembrolizumab.⁽⁴⁶⁾

The study will also investigate the alteration of the immune microenvironment within tumors and peripheral blood. Secondary endpoints include the objective response (complete response plus partial response), progression-free survival, and overall survival.

I/ONTAK is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK.

ONTAK was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market. Manufacturing improvements resulted in a new formulation, which maintains the same amino acid sequence but features improved purity and bioactivity. The new formulation received regulatory approval in Japan in 2021 for the treatment of CTCL and PTCL. In 2011 and 2013, the FDA granted orphan drug designation (ODD) to I/ONTAK for the treatment of PTCL and CTCL, respectively.⁽⁴⁶⁾

In September of 2022, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced a collaboration with Dr. Haider Mahdi at the University of Pittsburgh in an investigator-initiated trial to evaluate I/ONTAK (“denileukin diftitox” or “E7777”) in combination with pembrolizumab in the treatment of recurrent or metastatic solid tumors.

“We are honored to support Dr. Mahdi and his team at the University of Pittsburgh in this Phase 1 investigator-initiated study to evaluate I/ONTAK as a combination therapy in the treatment of solid tumors. This study will expand the body of knowledge about I/ONTAK’s unique mechanism-of-action targeting the CD25 component of the IL-2 receptor which is present on both malignant T-cells (T-cell leukemias and lymphomas) and immunosuppressive regulatory T-cells (T-regs),” stated Dr. Myron Czuczman, Chief Medical Officer of Citius.

“Preclinical research in a syngeneic solid tumor mouse model shows that E7777 (denileukin diftitox) enhances anti-tumor activity and significantly extends survival benefit of anti-PD-1 therapy. This data provides a positive signal of denileukin diftitox’s potential in the immuno-oncology space. There remains a significant ongoing need for innovative, effective, and well-tolerated treatments for cancer patients with solid tumors, and we are excited that I/ONTAK may provide meaningful antitumor activity in combination with the PD-1 inhibitor pembrolizumab (KEYTRUDA®),” added Dr. Czuczman.⁽⁴⁶⁾

Additionally, Citius is collaborating with an investigator-initiated study at the University of Minnesota (UMN). This Phase 1 dose-finding study to evaluate I/ONTAK prior to tisagenleucel (KYMRIAH®) CAR-T therapy in patients with diffuse large B-cell lymphoma (DLBCL) enrolled its first patient in May 2021.

The investigator-initiated trial at UPMC is an open label, Phase I/Ib study to evaluate T-reg cell depletion with I/ONTAK (E7777) in combination with pembrolizumab in recurrent or metastatic solid tumors.

“Encouraging clinical data emerging in the field of tumor immunotherapy have demonstrated that therapies focused on enhancing T-cell responses against cancer result in a significant survival benefit in patients with advanced malignancies. Overexpression of PD-L1 on tumor cells has been reported to impede anti-tumor immunity, resulting in immune evasion. The interruption of the PD-1:PD-L1 pathway combined with diminishing the suppressive effect by T-regs may represent an attractive strategy for restoring tumor-specific T-cell immunity. This first in human I/ONTAK plus anti-PD-1 combination immunotherapy study is a significant step towards advancing a T-cell-based therapeutic approach to treating solid tumors,” stated Dr. Haider Mahdi, University of Pittsburgh, Assistant Professor, Department of Obstetrics, Gynecology & Reproductive Sciences. Education & Training.⁽⁴⁶⁾

Additionally, Citius is collaborating with an investigator-initiated study at the University of Minnesota (UMN). This Phase 1 dose-finding study to evaluate I/ONTAK prior to tisagenleucel (KYMRIAH®) CAR-T therapy in patients with diffuse large B-cell lymphoma (DLBCL) enrolled its first patient in May 2021.

The investigator-initiated trial at UPMC is an open label, Phase I/Ib study to evaluate T-reg cell depletion with I/ONTAK (E7777) in combination with pembrolizumab in recurrent or metastatic solid tumors.

CITIUS PHARMACEUTICALS, INC. (NASDAQ: CTXR) REPORTS FISCAL FULL YEAR 2022 FINANCIAL RESULTS, PROVIDES BUSINESS UPDATE, ENDING THE YEAR WITH OVER $41 MILLION IN CASH.⁽³⁵⁾

• $41.7 million in cash and cash equivalents as of September 30, 2022; extends runway through December 2023.
• Mino-Lok® Phase 3 trial closer to completion with 169 patients recruited, 72 failure events and 17 patients in active treatment or pending data review.
• I/ONTAK BLA accepted for filing by the FDA; updated PDUFA target action date is July 28, 2023.
• Halo-Lido Phase 2b trial progressed; data readout expected 2H 2023.
• Multiple value-driving catalysts anticipated in 2023, including a potential drug approval and two trial completions.

On December 22, 2022 Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)reported business and financial results for the fiscal full year ended September 30, 2022.

Fiscal Full Year 2022 Business Highlights and Subsequent Developments Completed Pivotal Phase 3 trial of I/ONTAK (E7777) and submitted biologics license application (BLA) to the U.S. Food and Drug Administration (FDA).

FDA confirmed Prescription Drug User Fee Act (PDUFA) target action date of July 28, 2023.

Advanced Mino-Lok® Phase 3 trial.

Initiated Phase 2b trial of Halo-Lido for the treatment of hemorrhoids in April 2022; patient enrollment ongoing with data readout expected 2H 2023.

Initiated clinical collaboration with the University of Pittsburgh to evaluate regulatory T-cell (T-reg) depletion with I/ONTAK (E7777) in combination with pembrolizumab in recurrent or metastatic solid cancer tumors in a Phase 1 investigator-initiated trial, with first patient enrolled in November 2022.

Approved for $3.6 million in non-dilutive capital through the New Jersey Economic Development Program to support ongoing research and development efforts.

“In 2022, we focused on execution across our key development programs: I/ONTAK, Mino-Lok and Halo-Lido. These efforts, combined with a prudent use of funds, enabled us to meaningfully advance our pipeline. We believe we have sufficient runway through December 2023 to realize additional value-creating milestones, including a potential FDA approval and two anticipated trial completions in the coming calendar year,” stated Leonard Mazur, Chairman and CEO of Citius.⁽³⁵⁾

“Our Phase 3 Mino-Lok trial is now significantly closer to completion. While we expected to achieve 92 catheter failure events with 144 patients by the end of 2022, the trial’s observed catheter failure event rate has proven to be lower than anticipated. Consequently, we must continue recruiting patients. By successfully re-engaging with our U.S. trial sites as they recovered from the impact of CVD, we were able to drive patient recruitment. We have now exceeded our targeted enrollment and have achieved 72 of the required catheter failure events, with additional patients under review. To augment our recruitment efforts and continue the positive momentum in enrollment, we expanded the Mino-Lok trial to include sites in India. Once all new trial sites are fully activated, we will have nearly doubled our clinical site footprint. With these additional sites helping to drive incremental enrollment, we anticipate that the 92-event threshold required to complete the trial is achievable in the coming months,” added Mazur.⁽³⁵⁾

“During the year, we also completed a Phase 3 trial and submitted a BLA for I/ONTAK, an oncology asset we in-licensed just over a year ago. Upon further discussion with the FDA, the PDUFA target date has been set for July 28, 2023…

We remain committed to establishing a robust commercial infrastructure to support I/ONTAK’s successful product launch, if approved. In the second half of 2022, we also extended our support for a Phase 1 investigator-initiated study of I/ONTAK in combination with pembrolizumab (Keytruda®1) to treat patients with recurrent or metastatic solid tumors…

This study has begun recruiting patients and is the second investigator-initiated trial to explore I/ONTAK’s potential as a combination therapy in much larger immuno-oncology markets…

We continue to believe I/ONTAK’s value extends beyond a potential initial indication in persistent or recurrent cutaneous T-cell lymphoma. Earlier in the year, we announced our intention to spin off I/ONTAK. Given broader market conditions, we continue to evaluate opportunities to further unlock this asset’s value,” continued Mazur.⁽³⁵⁾

“In addition to advancing our Phase 3 trials, we initiated a Phase 2b trial for Halo-Lido, our prescription strength topical formulation for hemorrhoids. The trial began enrolling patients with symptomatic Grade II or III hemorrhoids in the second quarter of 2022. Recent recruitment has accelerated and we expect complete trial data available in the second half of 2023,” added Mazur.

“As financial stewards, we continuously evaluate the optimal capital structure for the company. We believe our anticipated catalysts, along with a healthy cash position, provide us with several strategic and financial options with which to continue advancing our pipeline…

This may include the previously announced potential spinoff of I/ONTAK into a standalone oncology company, pending market conditions, and other standalone financing alternatives available to us. We are encouraged by the multiple value-driving catalysts anticipated in calendar 2023, including a potential drug approval and two trial completions, and look forward to extending our positive momentum in the months ahead,” concluded Mazur.⁽³⁵⁾

NEWS

01/11/2023

Citius Pharmaceuticals to Present at the Sidoti Micro-Cap Virtual Conference on January 18, 2023

12/22/2022

Citius Pharmaceuticals, Inc. Reports Fiscal Full Year 2022 Financial Results and Provides Business Update

12/01/2022

Citius Pharmaceuticals, Inc. Announces U.S. Food and Drug Administration Acceptance of Biologics License Application of Denileukin Diftitox for the Treatment of Patients with Persistent or Recurrent Cutaneous T-Cell Lymphoma

11/21/2022

Citius Pharmaceuticals, Inc. Secures $3.6 million through New Jersey Economic Development Program

11/09/2022

Citius Pharmaceuticals Announces Efficacy and Safety Data for its I/ONTAK (E7777) Phase 3 Study for Treatment of Cutaneous T-Cell Lymphoma to be Presented at the 64th American Society of Hematology (ASH) Annual Meeting

10/18/2022

Citius Pharmaceuticals to Present at the ThinkEquity Conference on October 26, 2022

10/06/2022

Citius Pharmaceuticals to Present at Dawson James Securities Small Cap Growth Conference on October 12, 2022

09/28/2022

Citius Pharmaceuticals, Inc. Submits Biologics License Application to the U.S. Food and Drug Administration for Denileukin Diftitox for the Treatment of Patients with Persistent or Recurrent Cutaneous T-Cell Lymphoma

09/22/2022

Citius Pharmaceuticals Announces a Clinical Collaboration with the University of Pittsburgh to Evaluate T-reg Cell Depletion with I/ONTAK (E7777) in Combination with Pembrolizumab in Recurrent or Metastatic Solid Cancer Tumors in a Phase 1 Investigator-Initiated Trial

09/15/2022

Citius Pharmaceuticals, Inc. and its CFO & CBO Jaime Bartushak Honored by Somerset Hills Learning Institute

09/08/2022

Citius Pharmaceuticals, Inc. to Present at the H.C. Wainwright 24th Annual Global Investment Conference

09/07/2022

Citius Pharmaceuticals, Inc. to Present at the H.C. Wainwright 24th Annual Global Investment Conference

08/11/2022

Citius Pharmaceuticals, Inc. Reports Fiscal Third Quarter 2022 Financial Results and Provides Business Update

07/12/2022

Citius Pharmaceuticals, Inc. Holds Pre-BLA Meeting with the FDA for I/ONTAK (denileukin diftitox) for the Treatment of Cutaneous T-Cell Lymphoma

05/25/2022

Citius Pharmaceuticals, Inc. Announces Intention to Spinoff Late-Stage Oncology Asset, I/ONTAK, into a New Standalone Publicly Traded Company

05/18/2022

Citius Pharmaceuticals to Present at the H.C. Wainwright Global Investment Conference on May 24, 2022

05/12/2022

Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2022 Financial Results and Provides Business Update

05/06/2022

Citius Pharmaceuticals to Accelerate Phase 3 Mino-Lok Trial by Expanding Trial Sites Internationally

05/03/2022

Citius Pharmaceuticals, Inc. Provides Business Update, Highlights Upcoming Milestones

04/26/2022

Citius Pharmaceuticals Enrolls First Patient in Phase 2b Study of Halo-Lido for the Prescription Treatment of Hemorrhoids

04/14/2022

Citius Pharmaceuticals to Present at the NobleCon18 Investor Conference on April 20, 2022

04/13/2022

Citius Pharmaceuticals Announces Key Management Realignment to Support Commercialization of Two Late-Stage Product Candidates

MANAGEMENT

LEONARD MAZUREXECUTIVE CHAIRMAN, DIRECTOR

Mr. Mazur is an accomplished entrepreneur and pharmaceutical industry executive with notable accomplishments in founding and building multiple healthcare companies, and creating value and returns for investors. Mr. Mazur was the Chairman of Leonard-Meron Biosciences, Inc. prior to its merger with Citius in March 2016. He is also the cofounder and Vice Chairman of Akrimax Pharmaceuticals, LLC, a privately held pharmaceutical company specializing in producing cardiovascular and general pharmaceutical products. Akrimax was founded in September 2008, and has successfully launched prescription drugs while acquiring drugs from major pharmaceutical companies. From 2005 to 2012, Mr. Mazur co-founded and served as the Chief Operating Officer of Triax Pharmaceuticals LLC, a specialty pharmaceutical company producing prescription dermatological drugs. Earlier, he was the founder and Chief Executive Officer of Genesis Pharmaceuticals, Inc., a dermatological products company that marketed its products through dermatologists’ offices and co-promoted products for major pharmaceutical companies. In 2003, Mr. Mazur successfully sold Genesis to Pierre Fabre, a leading pharmaceutical company. Mr. Mazur has extensive sales, marketing and business development experience from previous tenures at Medicis Pharmaceutical Corporation, ICN Pharmaceuticals, Inc., Knoll Pharma (a division of BASF), and Cooper Laboratories, Inc.

Mr. Mazur is a member of the Board of Trustees of Manor College, and is a recipient of the Ellis Island Medal of Honor. Mr. Mazur received both his BA and MBA from Temple University, and served in the U.S. Marine Corps Reserves.

MYRON HOLUBIAKPRESIDENT AND CHIEF EXECUTIVE OFFICER, DIRECTOR

Mr. Holubiak has extensive experience in managing and leading both large and emerging pharmaceutical and life sciences companies. Mr. Holubiak was co-founder, director and CEO of Leonard-Meron Biosciences, Inc. prior to its merger with Citius in March 2016. From 1998 to 2001, Mr. Holubiak served as President of Roche Laboratories, Inc., a premier multinational research-based pharmaceutical company. As President of Roche, Mr. Holubiak helped transform Roche Labs into a leading antibiotic and biotechnology company. During his 19-year tenure at Roche Labs, Mr. Holubiak also held multiple sales and marketing roles. Prior to Roche, Mr. Holubiak founded Emron, Inc., a health economics and managed care consulting company, and helped establish the Academy of Managed Care Pharmacy (AMCP). From 2012 to 2016, Mr. Holubiak served as Chairman of the Board of Bioscrip, Inc., a national home infusion company. Since 2010, Mr. Holubiak has served as a member of the Board of Directors of Assembly Biosciences, Inc. and its predecessor, Ventrus Biosciences, Inc., and is a trustee of the Academy of Managed Care Pharmacy Foundation.

Mr. Holubiak received a BS in molecular biology and biophysics from the University of Pittsburgh. He received advanced business training from Harvard Business School and the University of London, as well as advanced training in health economics from the University of York’s Centre for Health Economics.

JAIME BARTUSHAKCHIEF FINANCIAL OFFICER

Mr. Bartushak is an experienced finance and operations professional for early-stage pharmaceutical companies, and has over 20 years of corporate finance, business development, M&A, restructuring, capital formation, and strategic planning expertise. Mr. Bartushak is a founder of Leonard-Meron Biosciences, and, as CFO, was instrumental in obtaining initial investment capital for its start-up in 2014. Earlier, Mr. Bartushak helped lead the sale of PreCision Dermatology, Inc. to Valeant Pharmaceuticals International, Inc., and before that, he led the financial efforts for the successful sale of Triax Pharmaceuticals to PreCision Dermatology.

Mr. Bartushak holds a Master of Science and BS from the New Jersey Institute of Technology.

MYRON S. CZUCZMAN, MDCHIEF MEDICAL OFFICER AND EVP

Dr. Czuczman is an experienced physician-scientist, academic oncologist, and pharma executive with decades of experience in strategic design, implementation, and oversight for the global development of novel therapeutics for hematologic malignancies. Dr. Czuczman joined Citius from Celgene where he was Vice President, Global Clinical Research and Development, Therapeutic Area Head of Lymphoma/CLL. In this role, Dr. Czuczman managed a global team of physicians and scientists responsible for cross-functional development of compounds from proof-of-principle to worldwide registration. Prior to his career in pharma, Dr. Czuczman practiced medicine for over two decades at Roswell Park Cancer Institute, an NCI-designated comprehensive cancer center in Buffalo, NY, where he served as chief of the Lymphoma/Myeloma Service and head of the Lymphoma Translational Research Laboratory. In addition to his extensive publications record, membership and leadership roles on national and international research organizations, and consulting and advisory to dozens of pharma companies, Dr. Czuczman also attained the positions of tenured Professor of Medicine at the State University of New York at Buffalo School of Medicine and Biomedical Sciences and Professor of Oncology at Roswell Park Comprehensive Cancer Center.

Dr. Czuczman received his medical degree from the Pennsylvania State University College of Medicine after graduating magna cum laude in biochemistry from the University of Pittsburgh. He completed his Internal Medicine residency training at Weill Cornell North Shore University/MSKCC Program, followed by Medical Oncology/Hematology fellowship training at Memorial Sloan-Kettering Cancer Center in New York City.

GARY F. TALARICOEVP, OPERATIONS

Mr. Talarico has served as EVP, Operations since March 2016. Mr. Talarico has successfully built and led all commercial activities for a number of start-up companies. Most recently, he was a founder, partner and Executive Vice President of Leonard-Meron Biosciences, Inc.; he was instrumental in acquiring its lead product. Previously, Mr. Talarico served as Senior Vice President of Triax Pharmaceuticals, from its founding to the sale of its assets. Mr. Talarico was a founder and Executive Vice President of Sales and Marketing for Reliant Pharmaceuticals, LLC; Reliant was later sold to GlaxoSmithKline plc. Before Reliant, he was Executive Vice President of Business Development for Ventiv Health. His earlier experience included tenures as Vice President of Sales for Medicis Pharmaceutical Corporation at its start-up, and Director of Sales at ICN Pharmaceuticals, Inc. Mr. Talarico is a graduate of Lewis University.

JAY WADEKARSVP, BUSINESS STRATEGY

Mr. Wadekar has been associated with Citius since its inception. Prior to Citius, he lead the clinical program at Ischemix, Inc., a company developing novel therapies for cardiovascular conditions. Mr. Wadekar has more than thirty years of experience in areas of finance, corporate strategy, sales and senior leadership in the healthcare field. Mr. Wadekar has held numerous executive level positions throughout his career in biotechnology and pharmaceutical industries including Chairman and CEO of Able Laboratories, Inc. Most recently he served as a strategic advisor to Camber Pharmaceuticals, Inc. where he was instrumental in building the executive team and establishing Camber’s Sales Operations systems.

ALAN LADER, PHDVP, CLINICAL OPERATIONS

Dr. Lader has served as VP, Clinical Operations since March 2016. Dr. Lader has over 25 years of experience in medical research. Prior to joining Citius, Dr. Lader was the Director of Clinical Operations for Ischemix, Inc. Dr. Lader was an Instructor in Medicine at Harvard Medical School and Brigham and Women’s Hospital, where he taught Integrated Human Physiology, and was Principal Investigator for NIH-funded studies in mechanisms of lung cancer metastasis. Dr. Lader has authored over 20 publications in peer-reviewed journals, and has presented more than 20 abstracts at scientific meetings. He received his PhD from the University of South Carolina School of Medicine. He received an MS degree from Rensselaer Polytechnic Institute in Biomedical Engineering and a BS degree in Bioengineering from Syracuse University.

ILANIT ALLENVP, INVESTOR RELATIONS

Ms. Allen has more than 20 years of experience in corporate communications, investor relations, strategy and investment banking. Since 2014, Ms. Allen has provided investor relations counsel to more than two dozen private and public life science companies. Previously, she advised executives across a broad spectrum of industries and growth stages, including technology startups and Fortune 500 financial institutions. Ilanit began her career as an investment banking analyst at SG Cowen with a focus on mergers and acquisitions. Ms. Allen holds an MBA from Harvard Business School, a Bachelor of Science degree in Finance from The Wharton School, and a Bachelor of Arts degree in International Relations from the University of Pennsylvania.

Sincerely,

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SOURCE LIST

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Source 50: https://citiuspharma.com/about/management-team/default.aspx

OUR NEW PROFILE IS:   (NASDAQ: GNPX)

________________________

GNPX HAS ALREADY RECEIVED FAST TRACK DESIGNATION FOR ACCLAIM 2

GENPREX ANNOUNCES U.S. PATENT FOR REQORSA™ IMMUNOGENE THERAPY IN COMBINATION WITH IMMUNE CHECKPOINT INHIBITORS TO TREAT CANCERS

INDEPENDENT RESEARCHERS FIND THAT TUSC2, THE GENE DELIVERED BY GENPREX’S REQORSA®, FUNCTIONS AS A NOVEL TUMOR SUPPRESSOR FOR GLIOBLASTOMA

GENPREX COLLABORATORS REPORT POSITIVE PRECLINICAL DATA WITH NPRL2 GENE THERAPY UTILIZING NON-VIRAL ONCOPREX® NANOPARTICLE DELIVERY SYSTEM IN NON-SMALL CELL LUNG CANCER AT THE 2023 AACR ANNUAL MEETING

CHECK OUT THE INVESTOR PRESENTATION HERE

_________________________

Genprex Collaborators Report Positive Preclinical Data With NPRL2 Gene Therapy Utilizing Non-Viral ONCOPREX® Nanoparticle Delivery System in Non-Small Cell Lung Cancer at the 2023 AACR Annual Meeting https://t.co/5nNUg4r0Bv $GNPX

— Genprex, Inc. (@genprex) April 19, 2023

Hello Everyone,

Our profile from Monday just hit .85, up 24% off the average trade and 45% off of the lows on the session.  Yesterday it pulled back before exploding all the way to .85 today on strong interest.  Congrats if you watched that one.

We have another exciting profile for tomorrow’s session that is picking up momentum this week and they just released two strong pieces of news.

Pull up GNPX right away.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes.

Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options.

Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches.

Genprex’s oncology program utilizes its proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans.

ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is then taken up by tumor cells that express tumor suppressor proteins that are deficient in the body.

The Company’s lead product candidate, REQORSA™ is being evaluated as a treatment for non-small cell lung cancer (NSCLC) (with each of these clinical programs receiving a Fast Track Designation from the Food and Drug Administration) and for small cell lung cancer.

Genprex’s diabetes gene therapy approach consists of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes directly to the pancreas.

In models of Type 1 diabetes, the genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system.

In Type 2 diabetes, where autoimmunity is not at play, it is believed that exhausted beta cells are also rejuvenated and replenished.

Research And Development Pipeline

CATALYSTS

– Addressing unmet medical need in large markets through the buildout of a robust pipeline of new drug candidates and drug combinations.

– Leveraging a gene therapy platform; Genprex’s non-viral ONCOPREX® Nanoparticle Delivery System is designed to deliver a variety of therapeutic genes to fight multiple types of cancer.

– REQORSATM immunogene therapy, the first systemically delivered gene therapy used for cancer in humans, can be combined with top-selling cancer drugs and may improve their benefits.

– Genprex has demonstrated clinical achievement with REQORSA in two clinical trials, showing a favorable safety profile and evidence of efficacy in lung cancer.

– GPX-002, Genprex’s diabetes gene therapy, works to transform alpha cells in the pancreas into insulin producing beta-like cells. A Phase 1 clinical trial could be the first-ever gene therapy tested in humans for diabetes.

– Advancing novel gene therapies in diseases with large markets and unmet needs.

– Two NSCLC trials currently enrolling; both with FDA Fast Track Designations.

– World class academic partners.

 

CLINICAL TRIALS

ONC-001

EVALUATING THE SAFETY OF REQORSA® IMMUNOGENE THERAPY AS A MONOTHERAPY (COMPLETED)

A Phase 1 dose escalation trial was conducted at The University of Texas MD Anderson Cancer Center evaluating the systemic, intravenous delivery of REQORSA® (TUSC2/FUS1) as a monotherapy in stage IV recurrent, metastatic lung cancer patients. The primary objective of this Phase 1 trial was to assess the toxicity of REQORSA administered systemically and intravenously, to determine the maximum tolerated dose, or MTD, and to determine a recommended Phase 2 dose of REQORSA alone.

THE FIRST SYSTEMICALLY DELIVERED GENE THERAPY USED FOR CANCER IN HUMANS

The study showed for the first time that a tumor suppressor gene can be delivered systemically, intravenously and selectively to a patient’s cancer cells using a systemic nanoparticle vector. Although this trial was not designed to show changes in outcomes, a halt in cancer growth was observed in a number of patients. REQORSA was well tolerated with tumor responses noted in lung primary and metastatic cancers in the liver, pancreas, and lymph nodes. In addition, pre- and post-treatment patient biopsies demonstrated that intravenous REQORSA selectively and preferentially targeted patients’ cancer cells.

Metabolic Tumor Response in a Metastatic Lung Cancer Subject

This subject survived after subsequent therapy more than seven years after the final treatment with REQORSA, to our knowledge, without evidence of cancer progression in the responding sites.

ONC-002

COMBINING REQORSA® IMMUNOGENE THERAPY WITH TARCEVA (ERLOTINIB)

PHASE 1 PORTION COMPLETED; PHASE 2 PORTION NO LONGER ENROLLING DUE TO OUR CHANGE OF FOCUS TO CONDUCT ACCLAIM-1

A Phase 1/2 clinical trial evaluated REQORSA® in combination with Tarceva® in stage IIIB/IV lung cancer patients without an activating EGFR mutation and in patients with an activating EGFR mutation whose cancer has progressed on Tarceva therapy.  Patients without the EGFR mutation represent the vast majority of lung cancer patients. However, such patients generally are not candidates for Tarceva therapy.

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In the Phase 2 trial combining REQORSA with Tarceva, subjects received REQORSA in combination with Tarceva every 21 days until the occurrence of progressive disease (PD), unacceptable toxicity, withdrawal of consent, or study treatment discontinuation for other reasons, whichever occurred first. We believe that the results from the Phase 2 trial are encouraging. Out of 10 patients, 9 had received 2 or more cycles and were therefore evaluable for response. Four patients had tumor regression. The median duration of response is three months. The disease control rate (CR+PR+SD > 8weeks) was 78%, which substantially exceeds the 7% response rate (with no CRs) and 58% disease control rate reported for the LUX-Lung 1 trial, a clinical trial of Gilotrif (afatinib) in a comparable group of patients.

TECHNOLOGY

REQORSA® IMMUNOGENE THERAPY

THE FIRST SYSTEMICALLY DELIVERED GENE THERAPY USED FOR CANCER IN HUMANS

Our lead product candidate, REQORSA®  immunogene therapy (quaratusugene ozeplasmid) for non-small cell lung cancer (NSCLC), uses the company’s unique, proprietary ONCOPREX® Nanoparticle Delivery System, which we believe is the first systemic gene therapy delivery platform used for cancer in humans. In 2020, the FDA granted Fast Track Designation for REQORSA in combination with AstraZeneca’s Tagrisso® (osimertinib) in late-stage NSCLC patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. In 2021, the FDA granted Fast Track Designation for REQORSA in combination with Merck & Co’s Keytruda® (pembrolizumab) in late-stage NSCLC patients whose disease progressed after treatment with Keytruda.

The active ingredient in our lead product candidate, REQORSA, is the TUSC2 gene, a tumor suppressor gene.

REQORSA consists of the TUSC2 gene encapsulated in a nanoparticle made from lipid molecules with a positive electrical charge. REQORSA is injected intravenously and can specifically target cancer cells, which generally have a negative electrical charge. Once REQORSA is taken up into a cancer cell, the TUSC2 gene is expressed into a protein that is capable of restoring certain defective functions arising in the cancer cell. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance.

We believe that REQORSA, unlike other gene therapies, which either need to be delivered directly into tumors or require cells to be removed from the body, re-engineered and then reinserted into the body, is the first systemic gene therapy used for cancer in humans.

OVERCOMING DRUG RESISTANCE

REQORSA is a pan-kinase inhibitor shown to simultaneously inhibit the EGFR and AKT oncogenic kinase pathways in vitro and in vivo. Once the cancer cell takes up the nanoparticle containing TUSC2, it is reprogrammed to die. Resistance to targeted drugs and checkpoint inhibitors develop through activation of alternate bypass pathways. For example, when PD-1 is blocked, the TIM-3 checkpoint is up-regulated. We believe that REQORSA’s multimodal activity will block emerging bypass pathways, reducing the probability that drug resistance develops.

To learn more about scientific evidence and studies supporting REQORSA and the TUSC2 gene, please refer to our Clinical Trials and TUSC2 Bibliographypages.

GPX-002

DIABETES GENE THERAPY

GPX-002, a gene therapy for diabetes, is the most recent addition of our licensed technologies. GPX-002 was developed by researchers at the University of Pittsburgh. Diabetic mice studies have shown that GPX-002 restored normal blood glucose levels for an extended period of time, which could translate to decades in humans. This gene therapy could not only become a new treatment option for millions of diabetes patients who need insulin replacement therapy, but it holds the potential to provide long-term effectiveness, or may even be a cure, for diabetic patients.

The diabetes gene therapy, GPX-002, is comprised of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes to the pancreas. The genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system.

Diabetic mice studies show that the gene therapy restored normal blood glucose levels for an extended period of time, typically around four months. The duration of restored blood glucose levels in mice could translate to decades in humans.

The diabetes gene therapy was developed by Dr. George Gittes, a researcher at the Rangos Research Center at UPMC Children’s Hospital of Pittsburgh, where preclinical research is ongoing. GPX-002 has been tested in vivo in mice and nonhuman primates. Once sufficient preclinical data has been generated, we expect to begin a Phase I clinical trial in diabetic patients, which could be the first-ever gene therapy tested in humans for diabetes.

To learn more about scientific evidence and studies supporting GPX-002 and the Pdx1/MafA genes, please refer to our Clinical Trials and Pdx1/MafA Bibliography pages.

ONCOPREX® NANOPARTICLE DELIVERY SYSTEM

THE FIRST SYSTEMIC GENE THERAPY DELIVERY PLATFORM USED IN HUMANS FOR CANCER

Our oncology drug development program utilizes our unique, proprietary non-viral ONCOPREX Nanoparticle Delivery System, which we believe is the first systemic gene therapy delivery platform used for cancer in humans. This platform, originally developed through collaborative research between the University of Texas MD Anderson Cancer Center and the National Institutes of Health, has been optimized to work with our initial product candidate, REQORSA® immunogene therapy.

DESIGNED TO DELIVER CANCER-FIGHTING GENES SYSTEMICALLY

The ONCOPREX platform has been designed and optimized to deliver cancer-fighting genes into the patient’s body systemically. Using this system, we encapsulate plasmids that express tumor suppressor genes within lipid nanoparticles and intravenously administer the encapsulated plasmids which are taken up by the tumor cells, after which the tumor suppressor genes express proteins that are missing or found in low quantities in the tumor cells. Our nanoparticles are non-immunogenic, allowing repetitive therapeutic dosing and have been clinically shown to deliver molecular kinase inhibitors effectively.

OPTIMIZED PARTICLE SIZE

Our systemic, nanoparticle, non-viral delivery system, which is being used in our clinical trials for the treatment of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), is designed to be small enough to cross tight barriers in the lungs but large enough to avoid accumulation in the liver, spleen and kidney. The nanoparticles have been shown to be taken up by tumor cells after REQORSA administration at up to 33 times the rate they are taken up by normal cells. The cationic charge of the lipid nanoparticles targets cancer cells, which facilitates endocytosis. Once inside the cancer cell, the TUSC2 gene activates signaling pathways that result in cell destruction or apoptosis.

ENHANCED SAFETY AND EFFICACY DESIGN

We have administered REQORSA to more than 50 patients in Phase 1 and 2 clinical trials using our systemic, proprietary, non-viral delivery system.

A Phase 1 clinical trial showed that systemic, intravenous therapy using the ONCOPREX Nanoparticle Delivery System was shown to selectively and preferentially target primary and metastatic tumor cells, resulting in clinically significant anticancer activity. The nanoparticles are non-immunogenic, allowing repetitive therapeutic dosing and providing extended half-life in the circulation.

Our earlier clinical trials have also shown that the ONCOPREX Nanoparticle Delivery System is well tolerated in humans and can safely deliver high therapeutic doses. We believe the ONC-001 clinical trial was the first systemic gene therapy clinical trial using a nanoparticle delivery system to deliver a tumor suppressor gene.

Genprex’s Diabetes Gene Therapy Program: A Major Step Forward in the Fight Against Type 1 Diabetes https://t.co/j1bZ1dlzZ1 $GNPX

— Genprex, Inc. (@genprex) March 16, 2023

GENPREX COLLABORATORS REPORT POSITIVE PRECLINICAL DATA WITH NPRL2 GENE THERAPY UTILIZING NON-VIRAL ONCOPREX® NANOPARTICLE DELIVERY SYSTEM IN NON-SMALL CELL LUNG CANCER AT THE 2023 AACR ANNUAL MEETING

APRIL 19, 2023

NPRL2 Gene Therapy Induces Effective Anti-Tumor Activity in Non-Small Cell Lung Cancer Pembrolizumab Resistant Tumors in a Humanized Mouse Model

Provides Preclinical Validation of the ONCOPREX® Nanoparticle Delivery System with a Second Tumor Suppressor Gene

AUSTIN, Texas — (April 19, 2023) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its research collaborators presented positive preclinical data for the NPRL2 gene (also known as the TUSC4 gene). The studies used the Company’s non-viral ONCOPREX® Nanoparticle Delivery System in KRAS/STK11 mutant anti-PD1 resistant metastatic human non-small cell lung cancer (NSCLC) humanized mouse models and were presented at the 2023 American Association of Cancer Research (AACR) annual meeting, which took place from April 14-18, 2023 in Orlando, Florida.

“We are pleased to have these positive data that support the therapeutic potential of our non-viral delivery system, which is being used in our current REQORSA® clinical oncology programs, presented before some of the world’s leading cancer researchers,” said Rodney Varner, President and Chief Executive Officer at Genprex. “The use of the ONCOPREX® Nanoparticle Delivery System to deliver the NPRL2 tumor suppressor gene positions Genprex to expand our clinical pipeline with a new drug candidate.”

“The preclinical data also provide further evidence that the ONCOPREX® Nanoparticle Delivery System has the ability to be successful using genes other than the TUSC2 gene that we are already using in clinical trials with REQORSA®,” stated Varner. “These compelling outcomes give us further confidence in the potentially broad-based application of our non-viral delivery system, which may provide a multitude of potential pipeline opportunities in the future.”

Genprex’s ONCOPREX® Nanoparticle Delivery System, is a novel non-viral approach utilizing lipid nanoparticles to deliver tumor suppressor genes that have been deleted during the course of cancer development. The platform allows for the intravenous delivery of various tumor suppressor genes, and potentially other genes, to achieve a therapeutic affect without the risk of toxicity often associated with viral delivery systems.

Featured Genprex-supported posters presented at AACR 2023 include:

Event: Americal Association of Cancer Research (AACR) Annual Meeting

Session Category: Immunology

Session Title: Combination Immunotherapies 2

Location: Section 22

Session Date and Time: Tuesday, April 18 from 1:30-5:00 p.m. ET

Title: “NPRL2 gene therapy induces effective antitumor immunity in KRAS/STK11 mutant anti-PD1 resistant metastatic human NSCLC in a humanizedmouse model”

Presenters: Jack A. Roth, MD, The University of Texas MD Anderson Cancer Center

Poster Board Number: 23

Abstract Presentation Number: 5120

The abstract entitled, “NPRL2 gene therapy induces effective antitumor immunity in KRAS/STK11 mutant anti-PD1 resistant metastatic human non-small cell lung cancer (NSCLC) in a humanized mouse model,” is available on the AACR website. The presentation reported results from this study, which investigated the antitumor immune responses to NPRL2 gene therapy on anti-PD1 resistant KRAS/STK11 mutant NSCLC in a humanized mouse model. In the study, humanized mice were treated with NPRL2 gene therapy, immunotherapy pembrolizumab (Keytruda®), or the combination. A dramatic antitumor effect was mediated by NPRL2 treatment, whereas pembrolizumab was ineffective. A significant antitumor effect was also found in non-humanized NSG mice, although the antitumor effect was greater in humanized mice, suggesting that the immune response played a role in inducing antitumor activity.

The study data suggest that NPRL2 gene therapy induces antitumor activity on KRAS/STK11 mutant anti-PD1 resistant tumors through DC mediated antigen presentation and cytotoxic immune cell activation.

A KRAS mutation occurs in approximately 25% of patients with NSCLC, and one study found that KRAS/STK11 combination mutations were found in approximately 6.5% of NSCLC patients.

“These data are encouraging because they not only validate Genprex’s non-viral oncology platform to deliver a variety of tumor suppressor genes, but they also provide further evidence of the important role that tumor suppressor genes play in cancer, particularly NSCLC,” said Mark Berger, MD, Chief Medical Officer at Genprex. “KRAS is the most frequent oncogene mutated in NSCLC, and KRAS mutations are often associated with resistance to drug therapy^[i]. Targeting KRAS/STK11 mutant NSCLC with the NPRL2 gene, and potentially with anti-PD1 as well, may provide therapeutic potential for this group of lung cancer patients.”

Genprex currently has three clinical trials evaluating the Company’s lead drug candidate, REQORSA® Immunogene Therapy (quaratusugene ozeplasmid) in lung cancer. The Acclaim-1 clinical trial, which received FDA Fast Track Designation, is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Tagrisso® (osimertinib) in patients with late-stage NSCLC with activating epidermal growth factor receptor (“EGFR”) mutations whose disease progressed after treatment with Tagrisso. The Acclaim-2 clinical trial, which received FDA Fast Track Designation, is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Keytruda® (pembrolizumab) in patients with late-stage NSCLC whose disease progressed after treatment with Keytruda. The Acclaim-3 clinical trial, expected to open for enrollment by the end of the third quarter of 2023, is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Tecentriq® (atezolizumab) in patients with extensive-stage small-cell lung cancer (SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as an initial treatment.

INDEPENDENT RESEARCHERS FIND THAT TUSC2, THE GENE DELIVERED BY GENPREX’S REQORSA®, FUNCTIONS AS A NOVEL TUMOR SUPPRESSOR FOR GLIOBLASTOMA

APRIL 18, 2023

Pre-clinical study results show TUSC2 overexpression reduces colony formation, neurosphere formation and promotes apoptosis in vitro, and suppresses tumor growth in vivo

Study adds to the growing body of research examining TUSC2 as a target for multiple other cancers

TUSC2 is the tumor suppressor gene used in the Company’s lead drug candidate, REQORSA® (quaratusugene ozeplasmid)

AUSTIN, Texas — (April 18, 2023) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that independent researchers recently presented preclinical data on the tumor suppressor gene, TUSC2, reporting that it functions as a novel tumor suppressor for glioblastoma. TUSC2 is the tumor suppressor gene that is reexpressed in tumors using REQORSA® Therapy treatment, Genprex’s lead drug candidate. Genprex has no affiliation with these researchers.

The independent researchers presented their abstract, titled, “Investigating TUSC2 for its tumor suppressive functions in glioblastoma and its role in gliomagenesis,” at the 2023 American Association for Cancer Research Annual Meeting on April 17. The abstract reports TUSC2 protein expression, but not mRNA expression, to be significantly decreased in glioblastoma as compared to normal brain. TUSC2 protein is destabilized in glioblastoma due to polyubiquitination by E3 ligase, neural precursor cell-expressed developmentally downregulated gene 4 (NEDD4), and degradation by the proteasome. The researchers determined that NEDD4 targets TUSC2 on lysine residue K71.

The researchers also reported that TUSC2 overexpression reduced colony formation and neurosphere formation and promoted apoptosis of glioblastoma cells in vitro, and suppressed tumor growth in vivo. Further, glioblastoma cells with CRISPR-mediated knockout (KO) of TUSC2 were highly aggressive in vitro and in vivo, demonstrating the role of TUSC2 as a novel tumor suppressor for glioblastoma.

In the study, researchers performed immunoprecipitation-mass spectrometry analysis to identify TUSC2-interacting proteins in both normal human astrocytes and glioblastoma cell lines. Results showed 95 and 88 TUSC2-interacting proteins in astrocytes and glioblastoma cell lines respectively, and 27 proteins were found to interact with TUSC2 in both astrocytes and glioblastoma.

“This research supports the growing body of studies evaluating TUSC2 as a target in oncology, and potentially an effective treatment, for many types of cancer,” said Rodney Varner, Chairman, President and Chief Executive Officer of Genprex. “We are encouraged by the increasing number of research institutions and independent researchers producing positive data on TUSC2, which provide additional support for REQORSA® and its therapeutic potential against cancers.”

REQORSA® Therapy is currently in development for the treatment of non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC). REQORSA® consists of the TUSC2 gene expressing plasmid encapsulated in non-viral nanoparticles made from lipid molecules (the Company’s ONCOPREX® Nanoparticle Delivery System) with a positive electrical charge. REQORSA® is injected intravenously and specifically targets cancer cells, taking advantage of leaky tumor vascularity, increased tumor pinocytosis, and attraction of positively charged lipid nanoparticles to negatively charged cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to cancer cells while minimizing their uptake by normal tissue.

According to the National Brain Tumor Society, glioblastoma is one of the most complex, deadly, and treatment-resistant cancers. More than 13,000 Americans were expected to receive a glioblastoma diagnosis in 2022. Glioblastoma accounts for 49.1 percent of all primary malignant brain tumors. There have only been five drugs and one device ever approved by the U.S. Food and Drug Adminstration for the treatment of glioblastoma.

Other independent researchers and studies have found that TUSC2 therapy may benefit other types of cancer, including head and neck, breast (including triple-negative breast cancer), renal cell (kidney), thyroid, and soft tissue sarcoma, as well as NSCLC and SCLC. For more information and additional studies supporting TUSC2, please refer to our Bibliography Page.

NEWS

GENPREX COLLABORATORS REPORT POSITIVE PRECLINICAL DATA WITH NPRL2 GENE THERAPY UTILIZING NON-VIRAL ONCOPREX® NANOPARTICLE DELIVERY SYSTEM IN NON-SMALL CELL LUNG CANCER AT THE 2023 AACR ANNUAL MEETING

APRIL 19, 2023

Provides Preclinical Validation of the ONCOPREX® Nanoparticle Delivery System with a Second Tumor Suppressor Gene

Read More

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INDEPENDENT RESEARCHERS FIND THAT TUSC2, THE GENE DELIVERED BY GENPREX’S REQORSA®, FUNCTIONS AS A NOVEL TUMOR SUPPRESSOR FOR GLIOBLASTOMA

APRIL 18, 2023

Pre-clinical study results show TUSC2 overexpression reduces colony formation, neurosphere formation and promotes apoptosis in vitro, and suppresses tumor growth in vivo

Read More

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GENPREX CEO COMMENDS FDA’S INITIATIVE TO ACCELERATE APPROVAL PROCESS FOR GENE THERAPIES

MARCH 23, 2023

Genprex is advancing its novel gene therapies for large patient populations with cancer and diabetes who currently have limited treatment options

Read More

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GENPREX TO PRESENT AT BIOPROCESSING SUMMIT CONFERENCE

MARCH 13, 2023

Genprex Chief Manufacturing and Technology Officer to Provide Insight on Manufacturing Gene Therapies

Read More

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GENPREX TO PARTICIPATE IN MARCH INVESTOR AND INDUSTRY CONFERENCES 

MARCH 8, 2023

Company to Showcase its Innovate Gene Therapy Programs in Oncology and Diabetes

Read More

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GENPREX, INC. ANNOUNCES $4 MILLION REGISTERED DIRECT OFFERING WITH A SINGLE, HEALTHCARE-FOCUSED INSTITUTIONAL INVESTOR

FEBRUARY 27, 2023

The gross proceeds from the offering are expected to be approximately $4 million, before deducting placement agent fees and other estimated offering expenses.

Read More

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GENPREX ANNOUNCES GROUNDBREAKING DATA FROM NON-HUMAN PRIMATE STUDY EVALUATING NOVEL GENE THERAPY TO TREAT TYPE 1 DIABETES AT 16^TH ANNUAL INTERNATIONAL CONFERENCE ON ADVANCED TECHNOLOGIES & TREATMENT FOR DIABETES 2023

FEBRUARY 23, 2023

Results show statistically significant decreases in insulin requirements, increases in c-peptide levels and improvements in glucose tolerance compared to baseline

Read More

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GENPREX SIGNS EXCLUSIVE LICENSE TO ADDITIONAL DIABETES TECHNOLOGY WITH THE UNIVERSITY OF PITTSBURGH

JANUARY 5, 2023

Technologies Licensed from University of Pittsburgh May Have the Potential to Provide Long-Term Efficacy and to Change the Course of this Disease for the Millions of Patients Around the World with Type 1 or Type 2 Diabetes

Read More

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GENPREX ANNOUNCES SELECTION OF PRECLINICAL DATA FOR ORAL PRESENTATION AT 16TH INTERNATIONAL CONFERENCE ON ADVANCED TECHNOLOGIES & TREATMENTS FOR DIABETES 

JANUARY 4, 2023

Exciting Data from University of Pittsburgh Researchers in Non Human Primates that Underpins Genprex’s Gene Therapy Program in Diabetes to be Showcased

Read More

GENPREX STRENGTHENS DIABETES GENE THERAPY PROGRAM WITH LICENSE OF ADDITIONAL TECHNOLOGY FROM UNIVERSITY OF PITTSBURGH

DECEMBER 15, 2022

Technology for modulating autoimmunity expands intellectual property portfolio

Read More

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GENPREX RECEIVES SAFETY REVIEW COMMITTEE APPROVAL TO PROCEED TO FINAL COHORT IN ACCLAIM-1 PHASE 1 DOSE ESCALATION TRIAL OF REQORSA® IN COMBINATION WITH TAGRISSO® IN ADVANCED NON-SMALL CELL LUNG CANCER

DECEMBER 14, 2022

Recommendation to Advance to Increased Dose in Third and Final Cohort of Phase 1 Portion of Trial Indicates Favorable Safety Profile of Novel Gene Therapy in Solid Tumor Cancer

Read More

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MANAGEMENT

Check out the management team here: https://www.genprex.com/about/company-management/

Sincerely,

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