We have been able to profile so significant movers over the past month. There have been a handful of low float bottom bouncers. Our profile from last Wednesday that we released at 2 pm has closed green 5 sessions in a row and hit .98 yesterday, up almost 100% from the .50 level from last Wednesday afternoon.
There is another company that we want to bring to your attention immediately.
This one closed green 4 sessions in a row heading into today and appears to be reversing off of bottom.
Pull up IVP Immediately.
The U.S. pet industry generated $103B in 2020. In 2017 there were 28,000+ pet hospitals in the U.S.
Inspire is an owner of general practice veterinary clinics in the United States. Inspire acquires practices, and, in many cases real estate, and then works with teams on a long- term basis to improve and maintain hospital operations, grow revenues and maximize earnings. As the Company expands, it is adding new services hospitals, including mixed animal facilities, critical and emergency care, and other specialty services such as equine, in one location.
THIS ONE JUST BOTTOM OUT AT .58 AND HAS BEEN STEADILY CLIMBING BACK TOWARDS THAT CRUCIAL 1 DOLLAR LEVEL SINCE THEN.
THE NEAR FUTURE
The 5-year plan includes a 10 location per year run rate for acquisitions and a public event within that timeframe which allows Inspire to share equity with all associates working in its locations.
DIFFERENTIATORS
Key relationships from the acquisition process through operations and the unique position of a publicly-traded veterinary services organization, provide us advantages in growth capability,
WHAT IS INSPIRE, WHAT IS THE 5 YEAR PLAN?
Key relationships from the acquisition process through operations and the unique position of a publicly-traded veterinary services organization, provide us advantages in growth capability, efficiency, and employee retention.
INSPIRE VETERINARY PARTNERS, INC. ANNOUNCES NON-BINDING LETTER OF INTENT TO ACQUIRE ANIMAL HOSPITAL AND ENTER THE STATE OF PENNSYLVANIA
Proposed acquisition to add one new animal hospital to Inspire’s network of 13 animal hospitals.
Expansion into a new state, Pennsylvania.
Pipeline of attractive acquisitions of animal hospitals remains active; Future acquisitions to be announced in 2023.
The transaction is anticipated to close October 2023.
VIRGINIA BEACH, VA / ACCESSWIRE / September 21, 2023 / Inspire Veterinary Partners, Inc. (Nasdaq:IVP) (“Inspire” or the “Company”), an owner and provider of pet health care services throughout the US, today announced that it has entered into a non-binding letter of intent to acquire a 100% ownership interest in one animal hospital located in Pennsylvania, a first for Inspire and follows its recently announced LOI for 2 animal hospitals in Oregon.
Inspire expects to acquire real estate associated with the purchase. The proposed acquisition is subject to customary closing conditions and is currently expected to be completed as early as the third quarter of 2023.
Inspire’s due diligence review of the target acquisition has already commenced, and upon satisfactory completion, the Company intends to proceed towards executing a definitive acquisition agreement and closing the transaction as soon as all closing conditions are met.
Kimball Carr, Chairman, Chair, President & Chief Executive Officer of Inspire, stated, “We’re excited to continue our growth nationwide and for Pennsylvania to be added to the list of states at which Inspire and our hospital teams serve clients and pets each day. We look forward to more anticipated growth in the great Commonwealth of Pennsylvania and the Eastern U.S.”
The letter of intent is non-binding and subject to additional diligence and other factors, and as such, there can be no assurance that the Company will enter into a definitive acquisition agreement or that the terms of any such agreement will not change, or that the proposed acquisition will be consummated in the third quarter of 2023 or at all.
INSPIRE VETERINARY PARTNERS, INC. ANNOUNCES NON-BINDING LETTER OF INTENT TO ACQUIRE TWO ANIMAL HOSPITALS AND ENTER THE STATE OF OREGON
Proposed acquisition to add 2 animal hospitals to Inspire’s network of 13 animal hospitals
Expansion into a new state, Oregon, constituting our first emergency veterinary clinic and first rehabilitation hospital
The transaction is expected to close as early as the third quarter of 2023
Opportunity to continue to acquire individual animal hospitals remains strong
VIRGINIA BEACH, VA / ACCESSWIRE / September 1, 2023 / Inspire Veterinary Partners, Inc. (Nasdaq:IVP) (“Inspire” or the “Company”), an owner and provider of pet health care services throughout the US, today announced that it has entered into a non-binding letter of intent to acquire a 100% ownership interest in two animal hospitals. The hospitals would represent expansion by Inspire into a new state, Oregon, and the Company’s first emergency veterinary clinic and first rehabilitation hospital under its network.
Inspire expects to acquire real estate associated with the purchases. The proposed acquisitions are subject to customary closing conditions and are currently expected to be completed as early as the third quarter of 2023.
Inspire’s due diligence review of the target acquisition has already commenced, and upon satisfactory completion, the Company intends to proceed towards executing a definitive acquisition agreement and closing the transaction as soon as all closing conditions are met.
Kimball Carr, Chairman, Chair, President & Chief Executive Officer of Inspire, stated, “We are very excited for this opportunity to acquire two new hospital teams who share our mutual belief that we can make a difference in the veterinary profession and serve even more clients and pets, for the first time, in the great state of Oregon.”
The letter of intent is non-binding and subject to additional diligence and other factors, and as such, there can be no assurance that the Company will enter into a definitive acquisition agreement or that the terms of any such agreement will not change, or that the proposed acquisition will be consummated in the third quarter of 2023 or at all.
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We have another profile that we want you to take a look at before the week is over.
If you have been a member for a while then you will certainly remember this one.
We profiled this one last year back in early December when it was sitting under .50, exactly where it is right now. By Mid February this one tapped 1.46 for a 200% move in just 2 months. BSGM certainly has a history of making big moves on positive news.
Pull up BSGM immediately before the weekend.
BSGM is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias. The Company operates within the rapidly growing electrophysiology (EP) marketplace – a market projected to reach $16B by 2028 with a 11.2% growth rate.
BioSig’s first product, the PURE EPTM System, is an FDA 510(k) cleared non-invasive class II device, that provides superior, real-time signal visualization allowing physicians to perform insight-based, highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy.
Having recently commenced PURE EPTM’s national commerical launch, the technology is already an integral part of many well-respected healthcare systems, including Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute. To date, physicians have completed approximately 3000 patient cases with the PURE EPTM System.
ACHIEVEMENTS
On January 10, 2023, we announced that Bellin Health entered into an agreement to acquire a PURE EP™ System. Through a formal evaluation, Bellin reported that clear cardiac signals positively impacted procedural efficiency resulting in cost savings per procedure.
Over 3,000 procedures have been performed using the PURE EP™ System with more than 80 physicians at 21 hospitals across the United States.
The PURE EP™ System was featured in an abstract presentation at the 15th Asia Pacific Heart Rhythm Society (APHRS) Scientific Session in Singapore. Results from the randomized study revealed the PURE EP™ System’s potential to promote shorter procedural times and higher cost savings during catheter ablation procedures.
BioSig’s PURE EP™ System was highlighted in a peer-reviewed case report by the Journal of Atrial Fibrillation & Electrophysiology (JAFIB-EP). This clinical abstract detailed the value of PURE EP™ and its groundbreaking High Frequency Algorithm (HFA) during pulmonary vein isolation.
A Master Research Agreement was signed with the Cleveland Clinic to explore expanded applications for its digital signal processing technology.
A purchase agreement was signed with San Antonio Methodist Hospital.
Launched PURE EP™ software Version 6 with ACCUVIZ™ Module highlighting the proprietary High Frequency Algorithm (HFA), a novel feature that identifies the key frequency components of cardiac data that can be difficult to identify within the traditional waveform presentation.
Cleveland Clinic, a leading Medical Center of Excellence, agreed to evaluate the PURE EP System, and a short time later requested a second system for evaluation.
A purchase agreement was signed with Kansas City Heart Rhythm Institute at Overland Park Regional Medical Center.
The PURE EP™ System was featured at numerous conferences including Kansas City Heart Rhythm Symposium 2022, the 17th Edition Venice Arrhythmias 2022 Congress, and EPLive 2022.
INVESTMENT HIGHLIGHTS
Disruptive and novel technology
Our technology saves procedural time and improves workflow efficiency in an environment where the technology has not changed meaningfully in 25+ years.
Substantial and growing global market
Global EP market is growing by 11.2% and expected to reach $16B by 2028.
Supports recurring revenue and continuous innovation.
Fortune 500 commercial team
Proven track-record of generating sales growth.
Well-protected IP portfolio
’59 Worldwide fundamental patents granted/allowed
BioSig’s New PURE EP™ Subscription Model Adopted by Mayo Clinic-Phoenix for World-Class Cardiac Care.
PURE EP™ subscriber community now includes two of top three U.S. health systems in cardiology: Mayo Clinic-Phoenix and Cleveland Clinic. Read the news release here:… pic.twitter.com/U6f19ZD4i7
BIOSIG’S NEW PURE EP™ SUBSCRIPTION MODEL ADOPTED BY MAYO CLINIC-PHOENIX FOR WORLD-CLASS CARDIAC CARE
PURE EP™ SUBSCRIBER COMMUNITY NOW INCLUDES TWO OF TOP THREE U.S. HEALTH SYSTEMS IN CARDIOLOGY: MAYO CLINIC-PHOENIX AND CLEVELAND CLINIC
Westport, CT, Nov. 02, 2023 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company committed to delivering unprecedented accuracy and precision to intracardiac signal visualization, announced today that Mayo Clinic-Phoenix—an existing user of the PURE EP™ Platform—has upgraded to the Platform’s subscription model to gain immediate access to the Company’s latest technological advancements in cardiac arrhythmia identification.
Harnessing the power of automation, PURE EP™’s latest software features debut unique algorithms that unlock signal data for electrophysiologists conducting even the most challenging ablation procedures.
Automatic Tachycardia Characterization (ATC) alerts electrophysiologists to heart conduction patterns that may be difficult to detect with the naked eye or that might warrant further evaluation.
Near-Field Tracking (NFT) monitors changes in the local unipolar electrogram to provide real-time tissue feedback that assists electrophysiologists as they make their final determinations between healthy and scarred tissue for lesion placement during an ablation.
“Our commitment to innovation and delivering exceptional patient care drives our ongoing collaboration with BioSig,” said Hicham El Masry, M.D., FHRS, Cardiac Electrophysiologist at Mayo Clinic-Phoenix. “The integration of PURE EP™’s advanced software features further reinforces our dedication to providing the best possible healthcare solutions for our patients. We look forward to the positive impact this partnership will have on our cardiac procedures.”
Mayo Clinic-Phoenix is ranked as the number one hospital in Arizona, according to the U.S. News and World Report. Within the specialty of cardiology, heart, and vascular surgery, the institution is ranked in the top one percent of hospitals nationwide (33 out of 4,515 hospitals).1
With Mayo Clinic-Phoenix and Cleveland Clinic now part of the PURE EP™ subscriber community, two out of the top three ranked health systems in cardiology, heart, and vascular surgery have embraced PURE EP™.2
“We are thrilled to roll out our newest, most innovative software to one of our company’s longest standing partners. As we continue building out PURE EP™’s software suite, customers will have the flexibility to purchase and add enhancements that meet their needs,” commented Gray Fleming, Chief Commercial Officer of BioSig. “By removing the burden of ownership and maintenance, we’re putting the latest PURE EP™ developments in physician’s hands as they unfold—unlocking the full potential of the electrophysiology lab.”
Leveraging full-spectrum signal data has significantly reduced ablation procedure times. Initial evidence suggested potential savings of approximately $418.20 per procedure using PURE EP™’s clear signals.3 Recent independent research by Cleveland Clinic shows PURE EP™’s unique unipolar capabilities may cut procedure times by up to 66%.4With the global cardiac ablation market set to exceed $14.5 billion by 2032,5 PURE EP™ offers substantial cost savings and efficiency gains for hospitals, improving patient outcomes through shorter procedures.
With a comprehensive suite of tools available through the subscription model, the PURE EP™ Platform can deliver the latest developments in electrophysiology to physicians as they emerge, with the flexibility to add enhancements as desired. For more information on how PURE EP™ can enhance arrhythmia identification and laboratory workflows, visit BioSig.com.
About The PURE EP™ Platform
The PURE EP™ Platform serves physicians by enabling the real-time acquisition of raw cardiac signal data—absent of unnecessary noise or interference inherent in traditional approaches. By leveraging a first-of-its-kind combination of hardware and software, the PURE EP™ Platform is designed to deliver unprecedented intracardiac signal purity that pushes the boundaries of cardiac arrhythmia identification, diagnosis, and treatment.
In a blinded clinical study recently published in the Journal of Cardiovascular Electrophysiology,5electrophysiologists rated PURE EP™ as superior to conventional systems for 75.2% of signal samples, with 87% earning a rating of equivalent or superior. Data presented at Heart Rhythm Society 2023 demonstrated the PURE EP™ Platform’s capacity to facilitate ablations in a third of the usual time, reducing procedure time and improving workflow efficiencies, without sacrificing accuracy, precision, or efficacy.
The PURE EP™ Platform is currently in a national commercial launch and an integral part of well-respected healthcare systems, including Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute.
BIOSIG ADDS FIVE NEW PATENT AWARDS TO 100+ TOTAL PATENT PORTFOLIO COVERING DIGITAL SIGNAL PROCESSING TECHNOLOGY AND AI
IP PORTFOLIO INCLUDES U.S. AND WORLDWIDE UTILITY AND DESIGN PATENTS AND PENDING APPLICATIONS IN THE U.S., EUROPE, AND ASIA-PACIFIC
Westport, CT, Nov. 01, 2023 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) a medical technology company committed to delivering unprecedented accuracy and precision to intracardiac signal visualization, announced today that the U.S. Patent and Trademark Office has awarded several new utility patents covering the Company’s PURE EP™ digital signal processing technology.
Kenneth Londoner, Chairman and CEO of BioSig, commented, “We are pleased to add five utility patent awards to our expanding intellectual property portfolio of more than 100 patents and patent applications in the U.S. and abroad. Our robust patent protection and well-constructed claims cover BioSig’s first mover advantage for our novel PURE EP™ Platform.”
New Patent Awards
U.S. Patent Application No. 16/543,061 was allowed on September 22, 2023 and is entitled “Systems and Methods To Display Cardiac Signals Based on a Signal Pattern.” The patent application describes and claims a computer method for viewing cardiac signals side by side and vertically stacked on top of each other as a pattern is matched to one of the cardiac signals.
U.S. Patent No. 11,737,699 granted on August 29, 2023 and is entitled “Systems and Methods for Performing Electrophysiology (EP) Signal Processing.” The patent describes and claims methods and systems for producing a clean unipolar signal.
U.S. Patent No. 11,737,701 granted on August 29, 2023 and is entitled “Methods, Systems and Media For Reconstructing Bioelectric Lead Placement.” The patent describes and claims methods and systems for reconstructing electrode placement on a patient using artificial intelligence.
U.S. Patent 11,617,529 granted on April 4, 2023 and is entitled “Apparatus and Methods for Removing a Large-Signal Voltage Offset from a Biomedical Signal.” The patent claims a method for processing an electrical signal having a large differential voltage offset.
U.S. Patent 11,617,530 granted on April 4, 2023 and is entitled “Apparatus and Methods for Removing a Large-Signal Voltage Offset from a Biomedical Signal.” The patent claims a system for the removal of noise in electrocardiogram (ECG) and intracardiac (IC) signals.
BioSig’s Total Patent Portfolio
35 issued and allowed utility patents
30 issued worldwide design patents
23 U.S. and foreign utility patent applications pending covering various aspects of the PURE EP Platform
1 allowed and 1 pending U.S. patent applications directed to artificial intelligence (AI)
Licenses to 11 patents and 9 additional worldwide utility patent applications pending from Mayo Foundation for Medical Education and Research
BIOSIG AI SCIENCES RECEIVES $2.2 MILLION IN SEED FUNDING TO ADVANCE DEVELOPMENT OF ARTIFICIAL INTELLIGENCE APPLICATIONS
DEAL TO CREATE ADDITIONAL VALUE THROUGH SUBSIDIARY TO ADVANCE ARTIFICIAL INTELLIGENCE STRATEGY WITHOUT DILUTION TO BIOSIG TECHNOLOGIES SHAREHOLDERS
Westport, CT, July 25, 2023 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company delivering unprecedented accuracy and precision to intracardiac signal visualization, today announced the completion of a seed funding round raising $2.2 million for BioSig AI Sciences, Inc. (“BAIS”), a subsidiary of the Company. BAIS intends to join BioSig’s world class technology team with external partners and collaborators to advance the research and development of an artificial intelligence (“AI”) medical device platform.
“The integration of AI and machine learning in electrophysiology devices is powering substantial expected growth for this market, and we intend to be a leader in developing applications of these technologies,” said Ken Londoner, Chairman, CEO and Founder of BioSig. “Our current platform and relationships have created interest and excitement and our development team are making demonstrations for early adopters” added Londoner.
BioSig and Reified Labs’ initial AI collaboration, which began in 2019, has resulted in multiple patent applications to date and a research publication on AI-enhanced electrocardiogram lead placement mapping. The renewed collaboration, BAIS, is also looking into the application of Chat-GPT like large language models and how they apply to helping our hospital partners leverage such technology to solve the myriad of challenges they currently face.
According to Data Bridge Market Research, the market for artificial intelligence in healthcare, estimated at $9.6 billion in 2022, is expected to reach $272.9 billion by 2030, at a CAGR of 51.9% during the forecast period.1
About BAIS BAIS, a majority-owned Delaware C Corporation subsidiary of BioSig, is developing AI solutions for the hospital marketplace utilizing structured, semi-structured, and unstructured data.
Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. I want to note that BSGM has a long-term relationship with the Mayo Clinic in the development of the PURE EP™ System.
Focused on PURE EP: The company has developed the PURE EP system whose enhanced signal acquisition, digital signal processing, and analysis provides key data used during ablation of cardiac arrhythmias. The PURE EP System is a FDA 510(k) cleared (in August 2018) non-invasive class II device.
Targeting heart disease: In the U.S., heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups, contributing to about 20 – 25% of deaths in the U.S. every year. Every 40 seconds, someone in the U.S. has a heart attack. Arrhythmia is a leading condition and contributing cause for heart disease.
PURE EP system: The PURE (Precise Uninterrupted Real-time evaluation of Electrograms) EP (Electrophysiology) System is designed to provide essential diagnostic signals during all types of cardiac catheter ablations (a procedure that involves delivery of energy through the tip of a catheter to correct heart rhythm arrhythmias). PURE EP is designed to address long-standing limitations that slow and disrupt cardiac catheter ablation procedures, such as environmental lab noise, signal saturation, slow signal recovery, and inaccurate display of fractionated potentials.
PURE EP benefits: PURE EP’s features may allow physicians to better determine precise ablation targets, strategy, and end point of procedures with the objective of reducing the need for patients to undergo multiple procedures, and to allow for less experienced EP physicians to perform more complex procedures. It is estimated that over half of cardiac ablation procedures are not successful (requires additional ablation procedures).
3,000 procedures and growing: To date, more than 3,000 patient procedures have been conducted with the PURE EP System by more than 80 electrophysiologists across 21 different clinical sites in the U.S. The PURE EP System is currently in national commercial launch in the U.S. at healthcare systems such as Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute.
Market opp’s: According to Health Research International, it is estimated that there are 8,163 global EP lab rooms (with an estimated 3,500 in the U.S.) performing catheter ablations. The rapidly growing EP market is projected to reach $16Bn by 2028 (+11.2% annual growth rate).
However, challenges exist: BioSig operates in a highly competitive environment and competes against a wide range of other technologies. There is the chance that competing technologies may challenge BioSig technologies or that existing standard of care methods remains the industry standard.
NEUROCLEAR
NOVEL ENG PLATFORM TECHNOLOGY
Our technology aims to address technological deficiencies present in the current electroneurogram recording systems through high-speed recording of biomedical signals, the ability to preserve valuable clinical information and optimization of therapy delivery through closed feedback loop.
Our first product focuses on improving safety and efficacy of renal denervation procedures.
INTRODUCING N-SENSE
Multi-channel hardware designed to sense & stimulate nerves.
Simultaneous stimulation and measure for optimal closed loop feedback system.
Aid in targeting nerve location.
Algorithms tailored to specific applications.
Assess nerve for hyperactivity.
Catheter-agnostic interface.
PARTNERSHIPS
We have partnerships with some of the most distinguished organizations and experts in the fields of electrophysiology, intellectual property (IP) strategy, and technology development.
In 2017 we signed a ground-breaking 10-year strategic collaboration with experts at Mayo Clinic to both develop advanced clinical features of the PURE EP™ System and explore new disease areas and applications. We expect our collaboration to result in joint patent filings and licensing opportunities. Our research program with Mayo Clinic is run under the leadership of Samuel J. Asirvatham, M.D., Vice-Chair of Innovation and Medical Director, Electrophysiology Laboratory.
We have worked closely with leading patent experts to develop a robust IP strategy. Our IP strategic advisor – Sherpa Technology Group (STG) – is one of the best in the field, working at the intersection of business, technology, and intellectual property. Our patent attorneys, Sterne, Kessler, Goldstein & Fox, are equally distinguished and have been on the cutting edge of IP law for four decades.
We also have a technology development partnership with Plexus Corp. [Nasdaq: PLXS]. Their engineering and manufacturing capabilities and outstanding expertise in building complex medical devices make Plexus a foundational cornerstone to support BioSig’s growth objectives now and well into the future.
KEY GROWTH DRIVERS
1) Advanced Technology — The non-invasive PURE EP System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology EP procedures in an EP laboratory under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. The PURE EP System aims to minimize noise and artifacts, and acquire high- fidelity cardiac signals. Improving cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving accuracy and efficiency of the EP studies and ablation procedures.
2) Market Opportunity — 2019 DRG Medtech 360 Report states the global EP device market is expected to exceed more than US $10.1 billion by 2024 and is growing at a compound annual growth rate (CAGR) of 11.3%. The Company also operates within the rapidly emerging field of bioelectronic medicine, estimated at $25.11 billion in 2020 with projected annual growth of 10.27%.
3) KOL Support — PURE EP has been used and valued by many of the industry’s leading electrophysiology physicians, including Dr. Andrea Natale of Texas Cardiac Arrhythmia Institute, and Dr. G. Joseph Gallinghouse. The Company achieved proof of concept validation through UCLA, and has performed numerous pre-clinical studies at Mayo Clinic, MN under the leadership of Samuel J. Asirvatham, M.D., Mayo Clinic’s Vice-Chair of Innovation and Medical Director, Electrophysiology Laboratory.
BIOELECTRONIC MEDICINE
Bioelectronic medicine is a rapidly growing field of healthcare that explores how targeted electrical signals can harness the body’s natural mechanisms to diagnose and treat a range of diseases. The field represents not just a narrow category of medical devices, but an entire approach to detecting and treating disease – using electrical pulses and the body’s own mechanisms as an adjunct or alternative to drugs and medical procedures.
Bioelectronic medicine applications aim to deliver treatment breakthroughs for many diseases that currently have a high level of unmet need. Researchers and innovators are exploring the field’s applications across various disease areas and disciplines, including neurology, auto-immune diseases, diabetes, arthritis, hypertension, pain management, cancer, and others. This wide range of applications sets bioelectronic medicine apart and indicates its immense potential.
We know we’re not alone in embracing a future with bioelectronic medicine. The field is making rapid strides, but this is just the beginning of what’s possible. That’s why we helped create the Alliance for Advancing Bioelectronic Medicine, an independent network of professionals dedicated to innovation at the intersection of healthcare and technology. We strive to develop this community with a common goal of realizing the field’s full potential.
Bioelectronic medicine is already a diverse, $20 billion market. It includes both familiar devices, such as pacemakers, as well as emerging technologies, such as vagus nerve stimulators and implantable neurostimulators. These exciting new segments are proliferating and attracting interest and investment from major players in technology and healthcare, such as Verily Life Sciences, Medtronic, and Johnson & Johnson.
As the field continues to develop, we believe our unique technology can play a critical enabling role. By providing more precise biomedical signals, our advanced signal processing capabilities can help clinicians better understand and change patterns to treat, or even prevent diseases.
Founder, Chief Executive Officer, Chairman, and Director
Mr. Londoner is a capital markets and capital architecture expert and a senior life science executive. Having started his career as a research analyst for J. & W. Seligman & Co., Inc., a leading institutional money management firm in New York City, NY, he quickly found himself at the forefront of the biotech industry in the early 1990s, leading him to manage $3.5 billion in mutual and pension funds and international assets.
His passion for medical innovation led him to co-found, govern and bring to the public market several life science companies, including BioSig Technologies, Inc. [NASDAQ: BSGM]. Working in close collaboration with key opinion leaders in electrophysiology, BioSig aims to improve the outcomes of cardiac ablations for the treatment of arrhythmias through novel technological solutions developed by the company and further apply its core competency in advanced biomedical signal processing and analysis to other areas of medicine.
His prior experience in recognizing the early potential of biotech led Londoner to for the Alliance for Advancing Bioelectronic Medicine, an independent non-profit network of professionals dedicated to innovation at the intersection of healthcare and technology. The Alliance aims to increase awareness of bioelectronic medicine and build a platform for collaboration among stakeholders. Over the last decade, Londoner formed top-level relationships with several medical centers of excellence such as Mayo Clinic, NYU Langone Hospital, and UCLA, as well as other stakeholders, including investment communities, intellectual property experts, and supply chain partners.
Mr. Londoner earned his BA in Economics from Lafayette College in 1989, and his Master of Business Administration in Management and Finance from New York University in 1994. Between 1999-2002, he served as an adjunct professor at the Columbia Business School. Additionally, in 2015, Mr. Londoner founded the Immersive Internship Program at Lafayette College.
STEVE BUHALY
Chief Financial Officer
Mr. Buhaly has over 15 years of CFO experience at three public U.S. companies. In 2007, he served as CFO to TriQuint Semiconductor who merged with RF Micro Devices, Inc. in a $4 billion merger agreement to form Qorvo in 2015. A world leader in innovative RF and power technologies, Qorvo grew into an $11 billion market capitalization during Mr. Buhaly’s tenure. Prior to TriQuint, Mr. Buhaly served as CFO of Longview Fibre where he played a key role in executing the $2.3 billion sale of the company. Earlier in his career, he held both chief operating officer and chief financial officer roles with electronic display company, Planar Systems.
Throughout his career, Mr. Buhaly has developed a strong cross-functional background in corporate finance, accounting, tax, IT, law, and investor relations. Having co-led strategic transactions resulting in over $2 billion in M&A transactions, he has helped companies raise $1 billion in the debt markets and was recognized for his leadership during TriQuint’s massive growth trajectory. Since 2018, Mr. Buhaly has served as an advisor to multiple early-stage and small businesses and currently consults for cancer treatment innovator, UbiVac.
Mr. Buhaly holds an MBA from the University of Washington.
GRAY FLEMING
Chief Commercial Officer
Mr. Fleming brings to the Company over 20 years in the healthcare industry, including 17 years at Abbott Laboratories and St. Jude Medical. During his tenure with Abbott, Mr. Fleming held several commercial leadership positions, including Vice President of Cardiac Sales, when he led sales and customer relationship management activities in some of the most significant strategic areas of focus. Mr. Fleming’s experience in delivering high-performing sales management initiatives led to substantial revenue growth with several key accomplishments, including the successful contracting of multiple leading IDN and GPO organizations. These initiatives resulted in some of the largest market share gains in the company’s history while also delivering substantial overhauls of historically underperforming regions throughout the Central Time Zone. Most recently, Mr. Fleming held the position of Chief Commercial Officer at Carecubes, a company created to provide a temporary and scalable negative pressure isolation technology solution based upon original joint request from the Defense Advanced Research Projects Agency (DARPA) and Centers for Disease Control and Prevention (CDC). Mr. Fleming holds a Bachelor of Business Administration degree with a Major in Marketing from Stephen F. Austin State University in Texas and a certificate in Leadership in Excellence and Development (LEAD) Program from the University of Texas.
JOHN SIECKHAUS
Chief Operating Officer
Mr. Sieckhaus brings to the Company 30 years in the healthcare industry, including 21 years at St. Jude Medical and Abbott Laboratories [NYSE: ABT]. During his tenure with St. Jude Medical, Mr. Sieckhaus held commercial leadership positions of rising responsibility, including U.S. National Sales Leader, Senior Vice President & General Manager when he led sales and customer relationship management activities in the United States across all cardiovascular product lines. Mr. Sieckhaus’s experience in building and leading high-performance teams, in addition to integrating multiple new and novel technologies and introducing them commercially, led to significant revenue growth for St. Jude Medical over his career. Most recently, Mr. Sieckhaus held the position of Vice President – Field Clinical Affairs for Abbott for the United States and CALA, where he created a world-class field clinical and monitoring team to support clinical trials across multiple business units within Abbott’s Cardiovascular portfolio. Mr. Sieckhaus holds a Bachelor of Science degree in Biomedical Engineering from Johns Hopkins University.
BRENDA CASTRODAD
Vice President, Human Resources
A seasoned executive, Ms. Castrodad brings a wealth of experience in leading organizational development in start-ups and Fortune 500 companies within the life sciences sector. Most recently, Ms. Castrodad led the HR department at TissueTech, Inc., a Miami, FL-based biotech leader in regenerative amniotic tissue-based products, where she was responsible for transformation and automation of the company’s HR practices, talent planning, and team building. Prior to TissueTech, Inc., Ms. Castrodad spent six years at HeartWare, Inc., a heart failure medtech company acquired by Medtronic [NYSE:MDT] in 2016 for $1.1 billion. By optimizing the internal talent acquisition function and aligning business practices, Ms. Castrodad helped grow the organization from approx. 80 to 500+ staff which achieved approx. $250 million in revenues before the acquisition. Earlier in her career, Ms. Castrodad spent 16 years at Schering-Plough Corp, a pharmaceutical company acquired in 2009 for $41.1 billion by Merck & Co. [NYSE:MRK]. Ms. Castrodad holds a Master’s Degree in Public Administration and a Bachelor’s Degree in Social Sciences – Human Welfare from the University of Puerto Rico and a Labor Relations Certificate from the University of Michigan.
ANDREW BALLOU
Vice President, Investor Relations
Mr. Ballou brings to BioSig over 25 years of experience in capital markets, including institutional equity sales and research analysis. Most recently, Mr. Ballou served as Managing Director, Head of Institutional Equity Sales at Janney Montgomery Scott LLC., a role in which he oversaw key accounts, including large multi-manager hedge funds, mutual funds and dedicated sector funds. Prior to that role Mr. Ballou managed selected key account coverage at RBC Capital Markets, including Millennium Partners, Soros Fund Management, SIR Capital, Columbia Threadneedle, Two Sigma Investments and Times Square Capital Management. During the course of his career Mr. Ballou analyzed various private and public companies in healthcare, media and retail sectors. Mr. Ballou graduated from Hampden-Sydney College, Virginia, with a Bachelor of Arts in English.
KATIE FRESHWATER
Vice President, Marketing
Ms. Freshwater brings over 20 years of sales and marketing experience in healthcare and technology, including senior positions at several leading medtech companies such as Cardinal Health, Medtronic, and Kimberly-Clark Healthcare. During her tenure at Cardinal Health, Ms. Freshwater served as Senior Director of Digital Marketing, e-Commerce, and Brand where she oversaw the development of marketing tech strategy and a team of 20+ digital marketers, content creators, and paid media strategists. More recently, Ms. Freshwater founded FRESH20 Consulting, where she has served as Senior Consultant providing independent marketing services and modern sales solutions for businesses ranging from early state startup-ups to large corporations.
At BioSig, Ms. Freshwater will work directly with all facets of the company on development, implementation, and management of the Company’s strategic and tactical marketing activities. She is responsible for developing and delivering a fully integrated marketing strategy, to include MarTech and MarCom functions. In addition, Mrs. Freshwater will support the Company’s brand visibility across print and digital media through best-in-class tailored approaches that drive sustainable growth for the business.
Ms. Freshwater holds a bachelor’s degree in business administration from the University of Denver and an MBA from Baylor University.
ZACHARY KOCH, CCDS, CEPS
Principal Advisor, Product Development
Zachary Koch brings over 20 years of experience in clinical strategy and sales in electrophysiology and cardiovascular devices. Mr. Koch joins BioSig’s leadership following a 16-year tenure at Abbott and St. Jude Medical, where he held numerous positions across the company’s clinical, sales, training, and commercial teams. Mr. Koch has personally supported over 5000 cardiac mapping procedures, and has created and lead several advanced training and education initiatives for St Jude Medical and Abbott EP. More recently, within his role as Manager of Strategic EP Clinical Development, Mr. Koch successfully founded and launched the Key Accounts Organization for Abbott EP and led the business and clinical strategy across nine National Key Accounts. These efforts generated a 20% increase in EP case volume and revenue for the company. He also founded the AAA advanced training program that led to a significant improvement of clinical support with the Key Accounts Organization. He has been recognized for his sales and business delivery as a three-time recipient of Abbott’s Field Service Award, an honor bestowed upon the top clinical specialists in the US sales division. He is also a certified electrophysiology and cardiac device specialist, a distinguished honor apportioned by the International Board of Heart Rhythm Examiners.
Mr. Koch served as a Hospital Corpsman in the United States Navy. He provided infantry medical support for the Second Marine Division and the Executive Medical Team at the National Naval Medical Center in Washington DC. He holds a degree in Cardiovascular Technology from the Naval School of Health Sciences, where he graduated with honors and distinction.
SINCERELY,
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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. 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WLDS is a growth company developing a non-invasive neural input interface in the form of a wrist wearable band for controlling digital devices using subtle finger movements. These digital devices include consumer electronics, smart watches, smartphones, AR glasses, VR headsets, televisions, PCs, laptop computers, drones, robots, etc.
Since our technology was introduced to the market in 2014, we have been working with both Business-to-Business (B2B) and Business to Consumer (B2C) customers as part of our push-pull strategy.
We are now in the transition phase from research and development to commercialization of our technology into B2B products. At the same time, we are in the final stage of manufacturing our first B2C consumer product, the “Mudra Band”, an aftermarket accessory band for the Apple Watch which allows touchless operation and control of the watch. Headquartered in Israel, the company was founded in March 2014 by Asher Dahan, Guy Wagner and Leeor Langer, with renowned expertise in the fields of analog sensors, signal processing, deep learning and machine learning algorithms, software, and human-computer interaction.
Year-To-Date Operational Highlights
Announced preorder availability for flagship consumer product, Mudra Band forApple Watch
Commenced commercial manufacturing of Mudra Band for Apple Watch
Launched AI-based Air-Touch functionality for Android
Filed patent application with United States Patent and Trademark Office for expandedAI-based immersion technology
Strengthened leadership team with the addition of Tamar Fleisher as Chief OperatingOfficer and Pankaj Kedia to advisory board
Announced Mudra Band compatibility with B2B and B2C smart glasses brands
Enabled new user experience for mobile gaming
Showcased Mudra technology at numerous industry conferences around the globeSubsequent to the second quarter of 2023:
Completed first manufacturing batch of the Mudra Band for Apple Watch; expects tobegin shipments in coming weeks
WEARABLE DEVICES UNVEILS NEW GESTURE & VOICE-CONTROLLED INTERFACE FOR ITS MUDRA BAND FOR APPLE WATCH
The integration allows users to harness both voice commands and gestures to control digital devices without the need for physical touch.
YOKNEAM ILLIT, ISRAEL, Oct. 26, 2023 (GLOBE NEWSWIRE) — Wearable Devices Ltd. (the “Company” or “Wearable Devices”) (Nasdaq: WLDS, WLDSW), a technology growth company specializing in artificial intelligence (AI) powered touchless sensing wearables, announced today the integration of a new gesture and voice controlled interface for its Mudra Band for Apple Watch and AirTouch technology that leverages Apple’s AI-based digital assistant, Siri.
The new integration provides users with an enhanced interactive experience, enabling them to use a combination of voice commands and natural gestures and movements to control devices, without the need for physical touch. The combination of voice assistance and AirTouch technology allows users to switch between devices using voice, then utilize AirTouch gesture detection capabilities to navigate and fine tune preferences such as volume, brightness, and more.
Guy Wagner, Chief Scientist Officer and Co-Founder of Wearable Devices, commented, “With natural human communication being a combination of speech and gestures, an interface that utilizes both voice and gesture recognition as an input method is an essential integration for our technology. To date, we’ve been able to develop a revolutionary product that allows for natural and touchless interaction with connected devices using AI-powered sensors to interpret subtle finger and hand movements. With the integration of speech, we are greatly expanding the scope and capabilities of our technology by adding an entirely new input method that leverages the virtual assistant AI technology found in many of our connected devices, making our products, and other connected products, more intuitive and easier to use than ever before.
WEARABLE DEVICES EXPANDS MUDRA LICENSING PROGRAM TO INCLUDE DEFENSE AND MILITARY APPLICATIONS
The Company has been approached by global defense and military organizations interested in incorporating advanced technologies into their operations
YOKNEAM ILLIT, ISRAEL, Oct. 23, 2023 (GLOBE NEWSWIRE) — Wearable Devices Ltd. (the “Company” or “Wearable Devices”) (Nasdaq: WLDS, WLDSW), a technology growth company specializing in artificial intelligence (AI)-powered touchless sensing wearables, today announced the expansion of its Mudra gesture technology licensing program (the “Licensing Program”) to include defense and military applications, in response to the increasing demand within this sector.
The Company has already received requests for quotes from leading global defense and homeland security companies seeking to evaluate Mudra technology for potential integration into their own products and operations. With the control of defense technology increasingly shifting to ground and field operators, Mudra gesture technology offers customized, easy-to-use, discreet solutions that can maximize efficiency and minimize margin for error in environments where these are of the utmost importance.
The Licensing Program provides original equipment manufacturers with the right to customize a reference design version of the Company’s award-winning Mudra gesture technology to meet the specific needs of their business. The Company’s proprietary technology is at the forefront of gesture recognition, using AI-based touchless sensing wearables to control devices with hand gestures. Through the Licensing Program, Wearable Devices is positioned to significantly expand its addressable market by enabling businesses to develop their own co-branded touchless control products.
Asher Dahan, CEO of Wearable Devices, commented, “Our expansion into the defense and military sector reflects the expanding demand for our technology and the variety of applications our technology can enhance and support. We’ve been approached by several leading defense and homeland security companies that have recognized the potential of our Mudra gesture technology in their products and operations. As defense technology becomes an imperative part of the defense industry, our customizable and user-friendly gesture solutions are ideally suited for the direction in which this market is headed.”
WEARABLE DEVICES ENTERED AN MOU WITH A LEADING XR SMART GLASSES OEM FOR ITS MUDRA LICENSING PROGRAM
YOKNEAM ILLIT, ISRAEL, Oct. 02, 2023 (GLOBE NEWSWIRE) — Wearable Devices Ltd. (Nasdaq: WLDS, WLDSW) (“Wearable Devices” or the “Company”), a technology growth company specializing in AI-powered touchless sensing wearables, today announced the signing of a non-binding Memorandum of Understanding (“MOU”) under its newly launched Mudra licensing program. The MOU has been signed with a leading Chinese original equipment manufacturer (“OEM”) of extended reality (“XR”) smart glasses.
Under the terms of the MOU, the XR smart glasses OEM will explore deploying Wearable Devices’ touchless technology into its own product suite. As defined in the MOU, upon successful evaluation, the parties would enter into a commercial license agreement.
This MOU is a testament to Wearable Devices’ commitment to expanding its cutting-edge technology through strategic partnerships, and it marks a significant milestone in the Company’s journey toward defining the future of human-device interaction.
Wearable Devices recently announced its new licensing program for the B2B market, the ‘Mudra Licensing’. With the new program, the Company will provide a royalty-based license agreement, where OEMs =will have the right to manufacture by themselves a custom reference design version combined with the Company’s touchless control technology.
“We’re thrilled to partner with one of the major players in the XR market,” said Asher Dahan, Chief Executive Officer of Wearable Devices. This collaboration could significantly advance the capabilities of XR smart glasses and headsets as well, offering users a more intuitive and immersive experience.”
Apple Watch Users Received The First Wearable Devices Mudra Bands
The Company delivered its award winning Mudra Band product to first customers, allowing them to control their Apple ecosystem devices…
MANAGEMENT
Asher Dahan
CEO & Co-Founder Director
Project execution expert. Talent in business leading and strategic planning. Manager and team leader. High expertise in major corporate decisions, experience managing the overall operations and resources of the Company.
Guy Wagner
Company President & Chief Scientist, Co-Founder Director
Hardware expert and main inventor. Multi- disciplinary expertise in board design, biomedical signal processing, embedded programming and sensor design.
Leeor Langer
CTO & Co-Founder
Algorithms expert. Machine learning, and signal / image processing developer. Lead algorithms engineer in industry and academia. Wrote several papers and articles.
Eli Bachar
Director
Director since 2016. Serial investor experience served as director in multiple companies (Xjet3D , 6 Over 6 Vision Ltd., GetSat Ltd., Silentium Ltd., Cupixel Ltd.)
Barry Kaplan
EVP US operation & Director
Director since 2018. From 2012 to 2021, Chief of Operations at Stuhrling Original Group of companies. From 2009 to 2014 founded and worked as CEO at KIVA watch. He was Chief Executive Officer and Chief Designer of Alexander Watch LLC from 2014 to 2017
Alon Mualem
CFO
An experienced CFO with diverse experience in multinational hi-tech, communication and industrial companies, both public and private companies. Previously served as the CFO of Eltek (NASDAQ:ELTEK), as the CFO of Mer Telemanagement Solutions Ltd., a company traded on NASDAQ. and as the CFO of Xfone Inc. and Xfone 018 Ltd.
Offir Remez
EVP of Business development and sales
A serial entrepreneur and a senior business executive with a proven track record among OEMs and international corporations. Co-founder and former President and VP BD of LucidLogix (acq. Google). Active board member and VP BD at Adshir (acq. Snap)Adv. board member at Play-Cast (acq. GameFly), 3DV (acq. Microsoft), North-Bit (acq. MagicLeap), Giraffic (acq. Roku)Co-founder & CEO of Enbaya
Shmuel Barel
CMO
International B2B and B2C marketing and sales expert on both Industrial and consumer products and services.
Highly experienced in business and marketing strategy, branding, digital advertising, media planning, multi-channel analytics, and customer support.
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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 THOUSANDUSDBY AMPLIFYIR INC FOR A ONE DAY WLDS 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.
We have another Nasdaq profile sitting under .50 with MAJOR bounce potential.
This is a company that has drifted lower over the past 6 months on extremely light interest.
Pull up SVRE immediately.
Founded in 2014 with a mission to make roads safer for drivers, passengers, and pedestrians alike, SaverOne develops cellular network-based technological solutions for reducing road accidents.
Our innovative system for identifying and limiting the use of certain apps on mobile devices while operating a vehicle has already been widely adopted by dozens of companies in Israel.
SaverOne is also developing an additional system that can detect and warn the driver of VRU’s (Vulnerable Road Users and pedestrians) crossing when the driver’s field of vision is extremely limited. This system is currently in advanced stages of development.
Located in Israel, the company currently employs over 40 employees in its research and development, sales, business, operations, and support departments. Traded on NASDAQ
Traded on NASDAQ since 2020 (TASE: SVRE Nasdaq: SVRE)
SaverOne’s product portfolio addresses two main automotive segments:
After-market segment: protecting existing cars, trucks, and buses; working with vehicle fleets.
Pre-Market OEM segment: integrating SaverOne’s Protection technology in the vehicle assembly line.
SaverOne’s system is installed in vehicles to provide a solution to the problem of driver distraction, as a result of drivers using distracting applications on the mobile phone while driving, in a way that endangers their safety and the safety of their passengers. This phenomenon is considered one of the main causes of road accidents in the world. According to the US National Highway Traffic Safety Administration, the annual cost of road accidents just in the United States, stands at about $870 billion each year, excluding the costs of serious injury or death, with a quarter of those accidents estimated to be related to the use of the mobile phones while driving. SaverOne’s technology specifically recognizes the driver area in the vehicle and prevents the driver from accessing distracting applications such as messaging, while allowing others (e.g. navigation), without user intervention or consent, creating a safer driving environment.
SaverOne’s primary target markets include commercial and private vehicle fleets that are interested in reducing potential damages and significant cost, vehicle manufacturers that are interested in integrating safety solutions to their vehicles, and insurance and leasing companies. SaverOne initially addresses car fleets with focus on the Israeli, European and US markets, as well as other markets around the world. SaverOne believes that ultimately increased focus on monitoring and prevention of cellular distraction systems in vehicles, in particular driven by upcoming expected EU regulation, will likely have a dramatic positive impact on the demand for its systems in the future.
The Company’s strategy is to provide its technology for installation to customers in the aftermarket as well as address OEM vehicle manufacturers, to install the Company’s protection technologies during the vehicle manufacturing process.
HOW THE SYSTEM WORKS
When the driver enters the vehicle, the system detects the cell phone in the driver’s area and connects to the SaverOne application.
When the vehicle starts moving, SaverOne shifts the phone to safe mode, preventing the use of all distracting applications (such as text messages or email), while allowing the use of non-distracting applications (companies can pre-define which applications can be used while driving).
Other passengers in the car can use their cell phones freely. If the phone in the driver’s area is not connected to the system, an alert sounds, reminding the driver to reconnect or place the phone outside the driver’s area.
While in Safemode, incoming messages are not displayed on the phone. Instead, the sender receives a pre-defined automatic message, such as: “I am driving and protected by SaverOne. You are welcome to call” (the message can be customized).
The Safemode is canceled once the vehicle stops, allowing full phone use.
When the engine is turned off, the driver will see all the messages that were not displayed while driving. The Child Reminder feature is activated, reminding the driver to check the back seat.
THIS ONE HAS DRIFTED LOWER OVER THE PAST 6 MONTHS ON EXTREMELY LIGHT INTEREST. IT HAS POTENTIAL TO BOUNCE FROM IT’S CURRENT LEVELS.
SAVERONE REPORTS FIRST HALF 2023 RESULTS WITH STRONG REVENUE GROWTH.
Revenue up ~4X YoY in H1 2023 and expects continued growth in H2 2023
PETAH TIKVAH, Israel, Aug. 29, 2023 /PRNewswire/ — SaverOne 2014 Ltd. (NASDAQ: SVRE) (TASE: SVRE), a company developing and deploying transportation safety and advanced driver-assistance systems (ADAS) technologies and solutions, today presented its results for the first half ended June 30, 2023 and shared some of its recent business updates.
Recent Highlights
SaverOne is successfully executing on its land-and-expand strategy by broadening initial penetrations locally to full fleets, as well as initial wins internationally including pilot projects in the United States, Europe and the Gulf region;
~4,300 systems have been ordered by customers as of August 29, 2023, of which approximately 3,000 have been installed;
SaverOne plans to advance development activities with IVECO during the fourth quarter subject to entry into formal agreement, with sales to customers planned for 2024.
Financial Highlights
~4X (286%) year-over-year growth in revenue to NIS 1.5 million (~$399 thousand) in the first half of 2023;
Gross margin of 32% in the first half of 2023 versus 30% in the first half of 2022;
Net loss of NIS 17.8 million (~$4.8 million) in H1 2023 versus NIS 11.9 million in H1 2022 (~$3.2 million) with higher net loss due to higher operating expenses given increased business activities in the current year;
June 30, 2023 cash and cash equivalents and short-term bank deposits of NIS 18.6 million (~$5.0 million).
Management Comment
Commented Mr. Ori Gilboa, CEO of SaverOne, “We are very pleased with our performance so far in 2023. Building on the momentum we achieved last year, we continue to see our business advance well and in-line with our strategy. In particular, we are especially pleased with the broadening of our footprint amongst existing customers following the successful completion of our pilot projects with them, demonstrating their satisfaction with our solution. Furthermore, in line with our strategy to expand into international markets, we are very happy with the recent initiation of key pilot projects in the United States, Europe and the Gulf region. These are all key milestones for our business and given our strong pipeline, we see further potential to expand internationally.”
“Given our solid results and the clear potential ahead of us, we are ever more optimistic about our long-term growth. Looking to the second half of 2023, we expect to continue the growth trend from our encouraging first half of the year,” concluded Mr. Gilboa.
Recent Developments Summary
Further recent international expansion: a new pilot project on buses of an additional county in the Gulf region; a second pilot project in the United States with a new customer, a fueling transportation company; and SaverOne’s first pilot in Europe marking an expansion with an existing customer.
SaverOne Strengthens Senior Management with Focus on Global Sales and Business Development:announced the appointment of Omri Hagai, as new CFO; Yoav Zilber appointed as Head of Business Development, US and Europe After-Market Product; Alon Refaeli appointed as Head of Business Development, Global OEM Market and Hila Vyzer appointed as Head of Israel Market Sales. The appointments augment and strengthen SaverOne’s management team and its go-to-market efforts in international markets as well as the local market in Israel.
Diplomat, a leading importer and distributor of consumer goods throughout Israel, signed an agreement with SaverOne for an initial pilot program on 20 trucks out of Diplomat’s full fleet of 45.
Cemex Group, a global leader in the building materials industry to install the SaverOne system across its entire employee car fleet and trucks in Israel. This follows two prior orders covering portions of the fleet and the system is now being deployed on over 380 of Cemex‘ vehicles. There remains significant further potential in Cemex Group around the world.
Garbage collection and recycling leader, Argaman Ichut Hasviva in Israel, to install the SaverOne System across its entire fleet of 20 garbage trucks operating throughout the country.
SaverOne expanded its footprint among private bus fleets with over 160 new installations for various customers in the private bus fleet sector in Israel.
Universal Trucks Israel, importer of Isuzu Trucks to Israel, to install SaverOne’s in-cabin DDPS on additional 40 Isuzu vehicles. This follows the successful implementation of the system in 100 Isuzu trucks in the first half of 2023. UTI represents significant further potential with a fleet of over 13,000 trucks and buses in Israel.
A pilot demonstration with Abu Dhabi’s Ministry of Transport was successfully concluded on a number of public buses in Abu Dhabi. The potential for this project is the installation of the SaverOne system on the entire 900 bus fleet of Abu Dhabi’s public transportation system. There is further potential given the thousands of school buses operated daily throughout the country, and ultimately SaverOne aims to provide the SaverOne System throughout the United Arab Emirates.
The Regional Council of Lev Hasharon to install the SaverOne system on its 14 school buses. The vertical of public transport is important in SaverOne’s global penetration strategy.
Shaltal, one of the largest vehicle transport fleets in Israel, to install the SaverOne systems across its fleet of 150 trucks. Following an initial pilot phase of 25 vehicles, the agreement provides that the SaverOne system will be installed on the remaining 125 trucks.
EzFill Holdings in Miami, Florida, started a pilot program with SaverOne, its first in the United Stateson selected fuel delivery trucks.
Moviley Dror a leader in logistics and shipping for the Israeli supply chain market, to install the SaverOne protection system across its full fleet of 150 vehicles. Moviley Dror works closely with leading international logistics companies, representing further potential for SaverOne.
SaverOne joins the European Union’s regulatory committee on driver distraction, the committee responsible for setting EU regulations for vehicle manufacturers (OEMs) for in-vehicle technologies that help detect driver distractions and improve road safety. SaverOne will participate in discussions, provide feedback and help craft regulations by contributing its strong expertise and insights to reduce driver distractions and better protect vulnerable road users.
Electra Afikim to install the SaverOne System across its entire bus fleet of ∼1,200 vehicles: Electra Afikim is one of the largest public transportation operators in Israel. The public transportation sector is a key vertical, with potential to protect millions of vehicles, drivers, passengers and VRUs worldwide.
Leading Israeli construction group, Shapir Engineering, specializing in infrastructure projects which operates a fleet of hundreds of vehicles, including heavy trucks and cement trucks, ordered the SaverOne System for an initial pilot of 20 trucks.
Kfar Giladi Quarries installs SaverOne System on its full fleet of trucks: One of the biggest companies in the quarrying industry in Israel installed the SaverOne System on its fleet of heavy trucks. This win brings an additional heavy-industry customer, an important vertical, where the potential fleet size just in Israel is estimated in the tens of thousands.
Emek Yizrael regional council installs SaverOne System on all of its school buses: The full potential for this vertical in Israel is 54 regional councils. Furthermore, this vertical holds much more significant potential with a goal of providing protection for students traveling on school buses in the United States, Europe and elsewhere.
SaverOne System Installed on the large food delivery trucks of Shufersal – Israel’s leading supermarket: The installation of the SaverOne System was completed on a group of 19 large delivery trucks with potential of the entire Shufersal truck fleet of 150 delivery trucks. This vertical of delivery trucks is a key growth area for SaverOne.
New collaboration with Colmobil – Israel Importer for Mercedez-Benz, Mitsubishi & Hyundai – to equip vehicles with SaverOne protection system. Under the collaboration agreement, Colmobil will work together with SaverOne to sell and install the SaverOne System into vehicles that it leases to its customers in order to prevent driver distraction from mobile phone use. This collaboration adds another key player in the Israeli market that will be able to lease vehicles to their customers with a SaverOne System pre-installed.
SaverOne System installed on 30 delivery trucks of Tempo beverages- Israel’s leading beverage company, out of the local fleet of 120. Tempo represents leading global brands such as PepsiCo, Nestle’s premium water and iced tea brands, Nestea, Perrier water, and many more. The vertical of delivery trucks represents significant growth potential for SaverOne as well as further potential with international brands.
Financial Summary for the First Half of 2023
Revenues increased by 286% to NIS 1,475 thousand (~$399 thousand) in the first half of 2023 compared to NIS 382 thousand (~$103 thousand) for the first half of 2022. This increase was mainly the result of increased sales of the SaverOne System with new and existing customers throughout the past year.
Gross profit increased by 306% to NIS 467 thousand (~$126 thousand), representing gross margin of 32% in the first half of 2023 compared to NIS 115 thousand (~$31 thousand), representing gross margin of 30%, in the first half of 2022.
Research and development expenses, net were NIS 12.2 million (~$3.3 million) in the first half of 2023 compared to NIS 10.2 million (~$2.8 million) in the first half of 2022. This increase was due to the development of the Company’s next generation technology geared for international markets.
Selling and marketing expenses were NIS 1.4 million (~$392 thousand) in the first half of 2023 compared to NIS 0.5 million (~$130 thousand) in the first half of 2022. The increase is attributable mainly to higher payroll and marketing expenses, as part of the Company’s efforts to increase sales.
General and administrative expenses were NIS 4.5 million (~$1.2 million) in the first half of 2023, compared to NIS 2.5 million (~$679 thousand) in the first half of 2022. The increase in these expenses was mainly due to additional costs associated with being a US listed public company as well as higher insurance expenses.
Operating loss was NIS 17.6 million (~$4.8 million) in the first half of 2023 compared to NIS 13.1 million(~$3.5 million) in the first half of 2022, primarily due to increased operating expenses as detailed above.
Financing expense, net, was NIS 115 thousand (~$31 thousand) for the first half of 2023 compared to financing income, net, of NIS 1.2 million (~$314 thousand) in the first half of 2022. The increase is derived primarily from the higher appreciation of the USD against the NIS in the first half of 2022 compared to the appreciation of the USD against the NIS in the first half of 2023.
Net loss in the first half of 2023 was NIS 17.8 million (~$4.8 million), compared to NIS 11.9 million (~$3.2 million) for the first half of 2022.
Cash and cash equivalents and short-term bank deposits as of June 30, 2023, amounted to NIS 18.6 million (~$5.0 million), compared with NIS 29.3 million (~$7.9 million) as of December 31, 2022.
The Company’s financial results are presented in accordance with IFRS as issued by the IASB.
*Unless otherwise noted, for the purposes of the presentation of financial data, all conversions from New Israeli Shekels (NIS) to U.S. dollars and from U.S. dollars to NIS were made at the rate of NIS 3.70 to $1.00, based on the representative exchange rate reported by the Bank of Israel on June 30, 2023.
SAVERONE EXPANDS PRESENCE ACROSS PRIVATE AND SCHOOL BUS FLEETS WITH SIX NEW CUSTOMER WINS
PETAH TIKVAH, Israel, Oct. 5, 2023 /PRNewswire/ — SaverOne 2014 Ltd. (NASDAQ: SVRE) (TASE: SVRE), a technology company specializing in transportation safety solutions, today announced the win of six new customers, advancing SaverOne’s footprint in the private bus fleet industry. The private bus fleet vertical, especially buses carrying school children, is key for SaverOne, representing significant growth potential internationally and has become an area of strategic focus for the Company.
SaverOne reported initial orders of 90 new installations of its in-cabin Driver Distraction Prevention Solution (DDPS), primarily on school buses. This represents only a portion of the full bus fleets of these customers and there remains strong potential for further orders in the coming weeks.
Ensuring passenger safety in both public and especially private and school bus transportation is of paramount importance. SaverOne’s DDPS removes a significant risk factor and a primary cause of road accidents by selectively disabling the driver’s mobile distractions. This safeguards passengers and other road users while preserving essential, non-distracting uses in compliance with each bus company’s strict safety guidelines.
Ori Gilboa, CEO of SaverOne, commented, “After securing our major deal earlier this year for over 1,200 vehicles with leading Israeli public bus company Elektra Afikim, we are continuing to grow and add new customers to our roster in this important vertical. We recently identified the private and school bus transportation verticals as a key strategic focus for SaverOne. We are now seeing solid and increasing traction among bus companies, especially those transporting and responsible for the safety of school children. As these new and growing orders demonstrate, customers and potential customers are increasingly recognizing the value of our solutions, both in Israel and internationally. Preventable accidents continue to claim lives and cause injuries. Our DDPS ensures that drivers remain focused on driving safely and undistracted, mitigating a significant risk.”
Jacob has decades of experience in management, entrepreneurship and investments, high-tech and venture capital. He leads a large number of start-ups towards financial success.
ORI GILBOA
CEO
Ori has extensive experience in managing companies with large volumes of activity in the automotive and retail industry. He served, among others, as the CEO of the Meir Group’s automotive division, the CEO of James Richardson, and the CEO of the Negev Group and more.
YOSSI COHEN
FOUNDER AND COO
Yossi brings more than 25 years of experience in the telecommunications and automotive industries. Combining in-depth business, operations and technical knowledge. Yossi has led global business, operational and technology activities over the past two decades.
OMRI HAGAI
CFO
Over 10 years of experience in the financial management of public companies.
Prior to SaverOne, Omri served as Director of Finance for BrainsWay & Disclosure and Reporting Controller of Israel Chemicals.
AVIRAM MEIDAN
VP OF R&D
Aviram has technological experience in communications and in the interface with the automotive industry. He has over 20 years of experience in developing multidisciplinary systems and managing development groups.
ISRAEL EYBI
CHIEF MARKETING AND SALES OFFICER
Over 25 years of experience in marketing, sales and business strategies.
Israel brings many years of key relevant and solid experience in the cellular IoT-automotive segments.
Prior to SaverOne, Israel served as Chief Customer Officer at the Bezeq Group, as well as Chief Customer Officer at Pelephone.
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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
NMTC HAS NO DEBT OUTSTANDING AS OF JUNE 30, 2023
NEUROONE® SUCCESSFULLY COMPLETES INITIAL ANIMAL IMPLANT OF NOVEL THIN FILM PADDLE LEAD FOR SPINAL CORD STIMULATION
PRODUCT REVENUE OF $630,000 IN Q3 2023, COMPARED TO $32,000 IN Q3 2022
COLLABORATION REVENUE OF $1.46 MILLION IN FIRST NINE MONTHS OF FY 2023, COMPARED TO $6,000 IN FIRST NINE MONTHS OF FY 2022
We have another biotech profile that we want you to put on your radar for todays session.
This one is sitting under a buck right now but is known for big multi-session swings.
We have profiled this company a couple of times in the past before. When we looked at this one back in June it jumped 35% in just 7 sessions. The time before that we witnessed a jump of 18% overnight!
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® Announces First Clinical Case Using Evo® sEEG Electrode in Robotic #Neurosurgery: Evo sEEG electrode used with Zimmer Biomet’s ROSA One® Brain during procedure at @ClevelandClinic.
— NeuroOne Medical Technologies Corporation (@N1MTC) May 17, 2023
NEUROONE® ANNOUNCES FIRST CLINICAL CASE USING EVO® SEEG ELECTRODE IN ROBOTIC NEUROSURGERY
Evo sEEG electrode used with Zimmer Biomet’s ROSA One® Brainduringprocedure at Cleveland Clinic
EDEN PRAIRIE, Minn., May 17, 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 first clinical case using the Evo® sEEG electrode in robotic neurosurgery. Performed by Dr. William Bingaman at Cleveland Clinic, the procedure was the first to utilize NeuroOne’s Evo sEEG electrode, exclusively marketed in the U.S. by Zimmer Biomet, with Zimmer Biomet’s ROSA One® Brain, a robotic platform that assists surgeons in planning and performing complex minimally invasive neurosurgical procedures.
Dave Rosa, CEO of NeuroOne, commented, “This clinical case utilizing our minimally invasive and high-definition electrode technology with ROSA One Brain is a major milestone in NeuroOne’s partnership with Zimmer Biomet. Now that Zimmer Biomet has commenced U.S. distribution of our Evo sEEG electrodes, this case study confirms the synergistic use of our product with Zimmer Biomet’s robotics platform which was the foundation of our interest to partner with Zimmer Biomet.”
The Evo sEEG electrode technology offers stereoelectroencephalography recording, brain stimulation and future development of ablation solutions targeted for patients suffering from multiple neurological conditions. In October 2022, NeuroOne received FDA 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.
NEUROONE® REPORTS THIRD QUARTER FISCAL YEAR 2023 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
EDEN PRAIRIE, Minn., Aug. 14, 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 announces its operating results for the fiscal third quarter 2023 ended June 30, 2023.
Fiscal ThirdQuarter 2023 and Recent Business Updates
Financial Highlights
Product revenue of $630,000 in Q3 2023, compared to $32,000 in Q3 2022
Collaboration revenue of $1.46 million in first nine months of FY 2023, compared to $6,000 in first nine months of FY 2022
Operating cash burn reduction expected with the completion of development of the OneRF™ Ablation System beginning in Fiscal Q4 2023
Evo® sEEG:
Completed limited launch at target centers by end of July; full launch with Zimmer Biomet expected by end of fiscal fourth quarter
Positive user feedback received on product evaluation forms
Initiation of new sites expected to ramp in fiscal fourth quarter
Received first order for calendar 2024 product supply from Zimmer Biomet
OneRF™Ablation:
Submitted 510(k) to FDA on June 8th
Poster presentation on OneRF Ablation System preclinical study at the Neurological Disorders Summit (NDS 2023) in Italy
Received feedback from FDA regarding 510(k) submission for OneRF Ablation System
Spinal Cord Stimulation Program:
Completed 28 day animal implants of the Company’s thin film spinal cord stimulation paddle electrodes without any adverse events or neurological complications
Filed a non-provisional patent for a novel conformable thin film paddle lead for spinal cord placement
Drug Delivery Program:
Successfully completed proof of concept testing of drug delivery into the brain in a small animal model at the Mayo Clinic in Rochester, Minnesota
Dave Rosa, CEO of NeuroOne, commented, “The Company continues to execute on a number of commercial, development and financing objectives. We are now beginning to expand the commercial launch of our Evo sEEG electrode with Zimmer Biomet after a successful limited launch. In addition, we received encouraging feedback from the FDA regarding the Company’s recent 510(k) FDA submission of the OneRF Ablation System and believe our previous timelines remain on track. We are excited by the potential of our drug delivery system currently in development after recent testing at the Mayo Clinic in Rochester Minnesota. We also recently raised gross proceeds of $6.0 million through a public offering which included new fundamental institutional investors without having to offer warrants and $2.5 million through the use of an ATM (at-the-market) facility. I am pleased with the Company’s continued execution on our strategic plan and I look forward to our future progress in the areas outlined.”
Upcoming Targeted Milestones
Evo sEEG:
Full market launch of Evo sEEG system with Zimmer Biomet
Expand sales training of the sEEG product line to Zimmer personnel
OneRF Ablation:
Poster presentation planned for the Congress of Neurological Surgeons (CNS) Meeting in September
Initiate component orders for OneRF ablation system for future commercialization
SCS Program:
Complete testing of an implantable pulse generator (IPG) for fluid ingress
Perform percutaneous placement of a paddle electrode in a human cadaver model
Drug Delivery Program:
Define product requirements for drug delivery system for both clinical and research use in the biotech and pharma industry
Complete large animal feasibility studies for drug delivery system into the brain.
Fiscal ThirdQuarter 2023 Financial Results
Product revenue was $630,000 in the fiscal third quarter 2023, compared to product revenue of $32,000 in the fiscal third quarter 2022. For the first nine months of fiscal 2023, product revenue was $1.2 million, compared to $102,000 for the same period in fiscal 2022. Collaboration revenue was $1.46 million in the first nine months of fiscal 2023, compared to collaboration revenue of $6,000 in the first nine months of fiscal 2022. Collaboration revenue was derived from the Zimmer Development Agreement and represents the portion of the exclusivity and milestone fee payments eligible for revenue recognition during the respective periods.
Total operating expenses in the fiscal third quarter 2023 were $3.8 million, compared with $2.8 million in the same period of the prior fiscal year. Research and Development (R&D) expense in the fiscal third quarter 2023 was $1.9 million compared with $1.2 million in the same period of fiscal 2022. Selling, General and Administrative (SG&A) expense in the fiscal third quarter 2023 was $1.9 million compared with $1.5 million in the prior year period. For the first nine months of fiscal 2023, total operating expenses were $10.5 million, compared with $8.6 million in the same period of the prior fiscal year. R&D expense in the first nine months of fiscal 2023 was $5.2 million compared with $3.5 million in the same period of fiscal 2022. SG&A expense in the first nine months of fiscal 2023 was $5.3 million compared with $5.1 million in the prior year period.
Net loss was $3.5 million for the fiscal third quarter 2023, compared to a net loss of $2.8 million in the prior year period. Net loss for the first nine months of fiscal 2023 was $8.7 million compared with $8.6 million in the same period of fiscal 2022.
As of June 30, 2023, the Company had cash and cash equivalents of $3.1 million, compared to $8.1 million in cash and cash equivalents and $3.0 million in short term investments as of September 30, 2022. The Company had working capital of $3.1 million as of June 30, 2023, compared to working capital of $9.1 million as of September 30, 2022.
On July 27, 2023, the Company consummated an underwritten public offering of its common stock from which the Company received $5.2 million in net proceeds. In addition, the Company sold common stock under the ATM program from which the Company received net proceeds of $2.5 million.
The Company had no debt outstanding as of June 30, 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.”
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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 ElectrodeThe 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.
Evo® Cortical Electrode* (less than 30-day use)
NeuroOne offers a 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.
• 7 times thinner and 8 times lighter than typical silicone electrodes1 • Reduced artifact and improved signal quality2 • Reduced inflammation based on published testing by Mayo Clinic3
Evo® sEEG Electrode* (less than 30-day use)
The Evo sEEG electrode technology offers stereoelectroencephalography recording, spinal cord stimulation, brain stimulation and ablation solutions. The first clinical case using the Evo sEEG electrode was performed intraoperatively by Dr. Robert Gross at Emory University for brain mapping at the subsurface level of the brain.
• Designed to be less invasive – reduced risk of brain plunge, may require fewer brain insertions • Improved signal quality vs. other devices1 • Proven implant accuracy1 • Automated manufacturing, precise and consistent quality1
*Caution U.S. Federal law restricts this device to sale by, or on the order of, a physician.
1NeuroOne data on file 2Bower R., et al. December 2017. Multi-Resolution intracranial EEG rodent recording system. (Abst. 2.062) 2017. American Epilepsy Society 3Worrell, G. et. al. December 2019. Commercial Scale Production of Thin-Film electrode arrays for Clinical Intracranial EEG. (Abst. 1.154), 2019. American Epilepsy Society)
OneRFTM Therapeutic Ablation Electrode System
OneRF is a developing technology that utilizes existing implanted sEEG diagnostic electrodes for RF ablation in nervous (brain) tissue to create tissue lesion(s). It is designed to be a safer and less expensive combination electrode, intended to improve patient outcomes, reduce procedures and overall treatment cost.
NeuroOne® Announces First Clinical Case Using Evo® sEEG Electrode Performed at @MayoClinic.
— NeuroOne Medical Technologies Corporation (@N1MTC) May 10, 2023
NEUROONE® ANNOUNCES FIRST CLINICAL CASE USING EVO® SEEG ELECTRODE
Evo sEEG electrodes used for brain mapping in epilepsy surgery
EDEN PRAIRIE, Minn., May 10, 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 that its first clinical case using the Evo® sEEG electrode was performed by Dr. Jamie Van Gompel at Mayo Clinic. Using a non-robotic stereotactic frame system, Evo electrodes were implanted successfully and met the Company’s product performance objectives.
Dave Rosa, CEO of NeuroOne, commented, “We would like to thank Dr. Van Gompel and his surgical team at Mayo for this ‘first in the world’ opportunity. We are ecstatic with the initial performance of our Evo sEEG electrodes which confirmed the results of many years of testing on the device. While we previously used the device intraoperatively, this was the first clinical case that was cleared by the FDA for less than 30 day use. We look forward to continued success with the launch of the technology as we continue the roll out of the technology through our distribution partner, Zimmer Biomet.”
NeuroOne provides a full line of electrode technology to address an estimated worldwide market of $100 million for patients requiring diagnostic brain mapping procedures. Epilepsy mapping procedures primarily utilize sEEG electrodes due to their less invasive insertion procedure, but less than 5% of people with drug-resistant epilepsy who are surgical candidates receive diagnostic procedures using sEEGs. NeuroOne believes there is a significant opportunity to expand market adoption of sEEG technology with broad U.S. distribution of its Evo product line.
Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.
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.
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.
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Hello Everyone,
We have another profile for you to watch pull up immediately and watch for the rest of todays session.
This is a Biotech that trades on the Nasdaq and is sitting under .20 as we speak.
This one has a 52 week high of 2.65, so it is safe to say there is massive upside from it’s current levels under the right conditions.
Pull up THAR Immediately.
Tharimmune, Inc. is a biotechnology company developing a portfolio of therapeutic candidates for rare immune, inflammatory, and oncologic diseases. The Company is progressing towards acquiring a clinical-stage asset, known to suppress chronic, debilitating pruritis or “uncontrollable itching” in primary biliary cholangitis (PBC), a rare orphan liver disease with no known cure. The Company’s early-stage immuno-oncology pipeline includes novel multi-specific antibodies targeting unique epitopes with novel mechanisms of action against well-known, validated targets in multiple solid tumors. Tharimmune has a license agreement with OmniAb, Inc. to access the company’s antibody discovery technology platform against specified targets.
HILLSTREAM BIOPHARMA PROGRESSING TOWARDS ACQUIRING CLINICAL STAGE ASSET AND ANNOUNCES CORPORATE NAME CHANGE TO THARIMMUNE, INC.
September 22, 2023
Expects to launch and complete a Phase 1 trial in Q4 2023
Tharimmune to begin trading under new ticker, THAR, on Monday September 25, 2023
BRIDGEWATER, NJ / ACCESSWIRE / September 22, 2023 / Hillstream BioPharma Inc., (NASDAQ:HILS), a biotechnology company developing innovative therapeutic candidates in rare immune, inflammatory and oncologic diseases announced a corporate name change to Tharimmune, Inc., (“Tharimmune”). The corporate name change is based on the Greek word “thárros“, translated to mean courage and reflects the transformation of the Company into a patient-focused, clinical development organization. The Company’s common stock will trade on The Nasdaq Capital Market under a new ticker symbol, THAR, effective as of Monday, September 25, 2023.
“Over the past few months, we have made significant progress in shifting the focus of the Company to align with our future vision to impact patients in serious need of new treatment options,” said Randy Milby, Chairman and CEO of Tharimmune, Inc. Our new name, dedicated to the courage of all people diagnosed with diseases of high unmet need, aligns with this focus as we shift into a patient-centric organization striving towards developing impactful and accessible products.”
Tharimmune is progressing towards acquiring a clinical stage asset, TH104, with a recently approved IND. TH104 has a dual mechanism of action by affecting multiple receptors, known to suppress chronic, debilitating pruritis or “uncontrollable itching”. The Company expects to close the acquisition in the fourth quarter as well launch and complete a phase 1 pharmacokinetic trial by year-end. The clinical data package is strengthened by the phase 1 clinical trials already conducted ex-US, which showed reliable bioavailability of the active ingredient in TH104 via transmucosal film technology in both healthy volunteers as well as people diagnosed with liver disease, including primary biliary cholangitis.
HILLSTREAM ENTERS INTO AN EXCLUSIVE OPTION AGREEMENT TO ACQUIRE A CLINICAL STAGE ASSET FOR CHRONIC PRURITIS
Anticipate completion of Phase 1 & Phase 2 clinical trials in chronic pruritis over the next approximately 12 months
Seeking first approval in an orphan disease, PBC, for the treatment of moderate to severe chronic pruritis in which more than 70% of patients suffer from chronic pruritis
BRIDGEWATER, N.J., Sept. 11, 2023 (GLOBE NEWSWIRE) — Hillstream BioPharma, Inc. (Nasdaq: HILS) (“Hillstream” or the “Company”), a biotechnology company developing therapeutic candidates targeting drug resistant and devastating cancer announces an exclusive option agreement to acquire a clinical stage asset, AV104, with a recently approved IND. AV104 has a dual mechanism of action by affecting multiple receptors, known to suppress chronic, debilitating pruritis or “uncontrollable itching”. The Company intends to first seek approval in an orphan disease for the treatment of moderate to severe cholestatic pruritis in patients with primary biliary cholangitis (PBC), a rare form of liver disease with no known cure in which more than 70% of patients suffer from chronic pruritis.
Embedded onto a proprietary transdermal buccal film which easily adheres to the inside of the mouth, AV104’s key features make it an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions. AV104’s active molecule, nalmefene, has a dual mechanism of action by affecting both the µ-opioid receptor and the kappa opioid receptor as well as inhibiting IL-17 inflammatory cytokine expression. These opioid receptors when stimulated and/or inhibited by the body’s natural ligands have been known to be involved in the body’s itch circuitry.
When the itch circuitry is imbalanced in diseased conditions, pharmacological intervention can help suppress this phenomenon which occurs in patients suffering from chronic pruritis. Nalmefene crosses into the circulation via a proprietary buccal delivery by adhering the drug-coated film inside the cheek where the film biodegrades in minutes and the drug is absorbed. The buccal delivery of the drug bypasses the liver’s first-pass metabolism thus creating high drug concentrations in the skin, an added benefit for treating conditions in which the liver may be impaired. The Company intends to complete a bridging pharmacokinetic phase 1 trial and a phase 2 proof-of-concept in PBC patients over approximately the next 12 months after alignment with the US FDA.
Hillstream believes AV104 has expansion opportunities in treating chronic pruritogenic conditions associated with cholestatic liver disease as well as other liver related and as non-liver related diseases including fatty and alcoholic liver diseases, non-alcoholic liver diseases and certain types of hepatitis. Chronic pruritis is significant in liver diseases as well as chronic kidney diseases, hemodialysis and atopic dermatitis.
“The past year has been a period of transformational change for our company,” said Randy Milby, CEO of Hillstream. “This exclusive option allows the company to bring a clinical-stage asset into the organization as we shift into a patient-focused biotechnology organization. This signifies our next step as we grow into a business model focused on clinical development.”
Webcast details
Hillstream BioPharma will host a webcast on Monday September 11 th at 4:30 pm ET to describe this opportunity in more detail.
The ErbB family of cell surface proteins are some of the most well-known and validated oncology drug targets including ErbB2 or HER2 (human epidermal growth factor receptor) and Erb3 or HER3. The family of antibodies and biologics against HER2 starting with HERCEPTIN® (trastuzumab) approved in 1998 for breast cancer, one of the first few anti-cancer antibodies, as well as PERJETA®, KADCYLA® and PHESGO® totaled $8.4 billion in 2022 sales for Roche/Genentech. Antibodies against HER2 and HER3 bind to different domains of the extracellular portion of the proteins or epitopes with trastuzumab binding domain IV of HER2 primarily. HER2 is also one of the most utilized targeting antigens for antibody drug conjugates to treat HER2 positive cancers with two approved antibodies, Roche/Genentech’s PERJETA® and Daiichi Sankyo/AstraZeneca’s ENHERTU®.
The Applied Biomedical Science Institute has developed technology to target unique functional epitopes of the cancer targets HER2 and HER3. Monoclonal antibodies being developed at ABSI are unique from the currently approved anti-HER2 antibodies. ABSI has granted under an exclusive option agreement to Hillstream, certain of its proprietary technology which if converted to an exclusive license agreement, will allow Hillstream to develop HER2 and HER3 antibodies, including multi-specific and Quatramer- based therapeutics incorporating portions of the antibodies.
HSB-0059: BISPECIFIC ADC
Antibody Drug Conjugates (ADCs) are a class of newly emerging therapeutics which may serve as “magic bullets” to treat certain cancers. They consist of a 1) a cancer killing chemotherapeutic payload, 2) an antibody-targeting a cancer cell and 3) a linker connecting the antibody to the payload. The problem with some ADCs targeting HER2 and/or HER3 essentially target the same epitopes as trastuzumab based domains. Our solution based on data an HSB-3215 (HER2/HER3) mAb backbone with HSB-0059 targets novel epitopes on HER2 while blocking natural ligands to HER3 and/or preventing heterodimers. ADCs can also have a potential “bystander effect” of its’ toxin payload. We intend to design ADCs whereby the toxin delivered to surrounding non-antigenic cancer tissue can be killed and maximize antitumor potential for this novel compound.
HSB-1940: ANTI-PD-1 (UNDRUGGABLE EPITOPES)
Picobodies are antibody “knob” domains comprised of cysteine-rich ultralong complementary determining region (CDR) H3 sequences of 30-40 amino acids, which have the potential to access challenging epitopes better than full size antibodies can. By combining Quatramers with their long half-life coated with a PD-1 Picobody™ to create HSB-1940, we intend to efficiently target novel epitopes with greater binding affinity than approved biologics. Antibodies derived from mouse or human sources use the surface formed by complementarity determining regions (CDRs) on the variable regions of the heavy chain/light chain heterodimer, which typically forms a relatively flat binding surface. Alternative species, particularly camelids and bovines, provide a paradigm for antigen recognition through novel domains which form the antigen binding site. However, for camelids, heavy chain antibodies bind antigen with only a single heavy chain variable region, in the absence of light chains. Meanwhile, in bovines, ultralong CDR-H3 regions form an independently folding mini-domain, which protrudes far out from the surface of the antibody and forms a “stalk and knob” structure which is diverse in both its sequence and disulfide patterns. The “knob” (Picobody) component can be expressed as an independent antigen binding domain. At ~4-6 kDa, these are three times smaller than a camelid “nanobody”, and are the smallest known antibody fragment. These atypical antigen binding sites of bovines potentially provide the ability to interact with different antigenic determinants, particularly recessed or concave surfaces, compared to traditional antibodies.
NEWS
FRI SEP 22ND, 2023
HILLSTREAM BIOPHARMA PROGRESSING TOWARDS ACQUIRING CLINICAL STAGE ASSET AND ANNOUNCES CORPORATE NAME CHANGE TO THARIMMUNE, INC.
THU SEP 21ST, 2023
DAWSON JAMES SECURITIES ANNOUNCES OCTOBER DATE FOR 8TH ANNUAL SMALL CAP GROWTH CONFERENCE
MON SEP 11TH, 2023
HILLSTREAM ENTERS INTO AN EXCLUSIVE OPTION AGREEMENT TO ACQUIRE A CLINICAL STAGE ASSET FOR CHRONIC PRURITIS
FRI SEP 8TH, 2023
HILLSTREAM BIOPHARMA TO PRESENT AT H.C. WAINWRIGHT 25TH ANNUAL GLOBAL INVESTMENT CONFERENCE SEPTEMBER 11-13
WED AUG 9TH, 2023
HILLSTREAM BIOPHARMA TO PRESENT AT THE SIDOTI MICRO-CAP VIRTUAL CONFERENCE ON AUGUST 16-17, 2023
THU JUL 20TH, 2023
HILLSTREAM ADVANCES NEXT-GEN MULTISPECIFIC ANTIBODIES FOR SOLID TUMORS WITH LEAD HER2/HER3 PROGRAM, HSB-3215
MON JUL 10TH, 2023
HILLSTREAM BIOPHARMA ANNOUNCES STRATEGIC REPRIORITIZATION OF PIPELINE TO TARGETING HER2/HER3 SOLID TUMORS VIA BISPECIFIC AND ADC ANTIBODIES AND BIOLOGICS
THU JUL 6TH, 2023
HILLSTREAM BIOPHARMA LICENSES TECHNOLOGY TO DEVELOP PROPRIETARY HER2 AND HER3 ANTIBODY DRUG CONJUGATES AGAINST DRUG-RESISTANT BREAST, LUNG, GASTRIC, AND OVARIAN CANCERS
MON MAY 15TH, 2023
HILLSTREAM BIOPHARMA STRENGTHENS ITS BOARD OF DIRECTORS WITH APPOINTMENT OF KELLY ANDERSON
TUE MAY 2ND, 2023
HILLSTREAM BIOPHARMA ANNOUNCES CLOSING OF PUBLIC OFFERING OF COMMON STOCK
MANAGEMENT
RANDY MILBY – CEO & CHAIRMAN
Mr. Milby was the former Chief Executive Officer and Member of the Board of Directors at CorMedix, a publicly traded biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of inflammatory and infectious diseases. A seasoned executive who led the increase in market capitalization from $3M to a peak of $350M of Cormedix while improving the company’s financial position with capital raises from equity markets. He oversaw efforts to gain CE Market approval of Neutrolin® in the European Union and held increasing roles of responsibility at Goldman Sachs and Dupont Merck prior in his career.
Sireesh Appajosyula joined as COO in July of 2023 and has served as a member of our board of directors since July 2021. Previously, he was SVP, Corporate Development and Operations of 9 Meters Biopharma, a company focused on rare and unmet needs and is Managing Member of Highpoint Pharmaceuticals, LLC, a pharmaceutical research and development company. In addition, since 2015, Mr. Appajosyula has served as Managing Partner of Channel BioConsulting, LLC, a company that assists in enhancing search and evaluation efforts for complementary assets to be added to existing portfolios of biopharmaceutical companies. Prior to 9 Meters, Mr. Appajosyula was at Salix Pharmaceuticals, Inc. (“Salix”) (Nasdaq: SLXP) in various roles in medical affairs, product commercialization and business development until its acquisition by Bausch Health (Nasdaq: BHC). Prior to Salix, he was involved in various roles at Amgen Inc., Critical Therapeutics, Inc. (now Chiesi) and Sanofi (formerly Aventis). Mr. Appajosyula received his Bachelor of Science and Doctor of Pharmacy from Rutgers University.
THOMAS HESS CPA – CHIEF FINANCIAL OFFICER
Thomas Hess is an experienced financial expert. From August 2014 until June 2021, Mr. Hess served as Chief Financial Officer and Senior Vice President of Finance of Genomind, Inc., a mental health company that developed and sold a pharmacogenomic test that analyzed how an individual’s genes may affect medication outcomes. From September 2011 until its sale in April 2014, Mr. Hess served as Chief Financial Officer and Executive Vice President of Finance of The Keane Organization, a comprehensive provider of unclaimed property services. Mr. Hess also previously served in various other capacities including, but not limited to, Chief Financial Officer and Senior Vice President of Yaupon Therapeutics, Inc.; Chief Financial Officer and Vice President, Finance of Adolor Corporation; Corporate Controller of Vicuron Pharmaceuticals, Inc.; and Senior Manager – Accounting and Audit of KPMG. Mr. Hess was formerly an adjunct faculty member/lecturer at Pennsylvania State University and DeSales University. Mr. Hess received his B.S. in accounting from The Pennsylvania State University and his MBA from Katz Graduate School of Business, University of Pittsburgh. Mr. Hess is a Certified Public Accountant in the state of Pennsylvania. He currently serves on the Alumni Council of Penn State and is the Chairman of the Nittany Lion Club Annual Fund.
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REVENUE GROWTH OF 55% YEAR-OVER-YEAR TO $8.5 MILLION AS COMPARED TO $5.5 MILLION IN FISCAL 2022
FIRST QUARTER OF FISCAL YEAR 2023 SHOWED REVENUE GROWTH OF 13% YEAR-OVER-YEAR TO $1.5 MILLION, COMPARED TO REVENUE OF $1.3 MILLION IN THE PREVIOUS YEAR
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 7.53 MILLION ACCORDING TO YAHOO
We have a new profile that we want you to research before the weekend.
This one has closed green 5 of the last 6 and has the potential to squeeze from these levels based on the size of the float and recent momentum.
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.
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
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.
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“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
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NETCAPITAL ANNOUNCES REVENUE GROWTH OF 55% FOR FISCAL YEAR 2023
Investor conference call to be held tomorrow, July 27, 2023, at 10:00 a.m. ET
BOSTON, MA – July 26, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (the “Company”), a digital private capital markets ecosystem, today announced financial results for its fourth quarter and fiscal year 2023 ended April 30, 2023.
“Fiscal 2023 marked a year of strong performance, highlighted by revenue growth of 55% and operating income of more than $2 million,” said Martin Kay, CEO of Netcapital Inc. “The value proposition of our business is becoming more evident as we continue to build scale and deliver a superior experience at a lower cost for issuers. We expect to offer secondary trading in private equities later in this year, a liquidity model that we believe will support expansion of both our investor and issuer communities, and generate a potential new revenue stream for Netcapital. As a back-to-back winner of the Fintech Breakthrough Award in 2022 and 2023, our brand is well-recognized for innovation and excellence, and well-positioned for value creation.”
Fiscal Year 2023 Highlights
● Revenue growth of 55% year-over-year to $8.5 million as compared to $5.5 million in fiscal 2022
● Operating income of $2.3 million compared to an operating loss of $1.0 million in fiscal year 2022
● Paid down $1 million in debt, closed two underwritten public offering for aggregate gross proceeds of $6.7 million, and uplisted to Nasdaq in July 2022
NETCAPITAL FUNDING PORTAL REVENUES INCREASE BY MORE THAN 100% TOTAL REVENUES INCREASE BY 13%
Internal Testing of Secondary Transfer Feature Begins
BOSTON, MA – September 14, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (the “Company”), a digital private capital markets ecosystem, today announced financial results for the first quarter of fiscal year 2024 ended July 31, 2023.
“We are delighted to announce a very strong quarter for our funding portal, delivering a more than doubling of revenue,” said Martin Kay, CEO of Netcapital Inc. “In addition, we maintained our strategic focus on the build-out of the software required to enable issuers and investors on the Netcapital platform the ability to access a registered alternative trading system (ATS) in order to engage in secondary trading of securities. We commenced internal testing of the secondary trading platform features this week, and we are excited about the potential for this liquidity model to support the continued growth of both our investor and issuer communities.”
First Quarter Fiscal 2024 Financial Highlights
● Revenue growth of 13% year-over-year to $1.5 million, compared to revenue of $1.3 million in the first quarter of fiscal year 2023.
● Year-over-year increase of 110% in revenue from our funding portal services, which increased by $197,356 to $375,856 in the three months ended July 31, 2023, compared to $178,500 in the three months ended July 31, 2022.
● Net loss of approximately $492,000 in the three months ended July 31, 2023, compared to net income of approximately $65,000 in the three months ended July 31, 2022.
● Diluted loss per share of $0.07 in the three months ended July 31, 2023, compared to diluted earnings per share of $0.02 in the three months ended July 31, 2022.
● First quarter net loss was driven primarily by higher marketing spend and increased payroll expenses that included $483,351 in stock-based compensation in the three months ended July 31, 2023, as compared to $32,953 in the three months ended July 31, 2002.
NEWS
10/16/2023
Netcapital to Present at the ThinkEquity Conference on October 19, 2023BOSTON, MA – October 16, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (the “Company”), a digital private capital markets ecosystem, announced today that CEO Martin Kay will present at the ThinkEquity Conference in New York on Thursday, October 19.
Netcapital to Present at the LD Micro Main Event XVI Investment Conference on October 4, 2023BOSTON, MA – October 2, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (the “Company”), a digital private capital markets ecosystem, announced today that Martin Kay, CEO, will present at the LD Micro Main Event XVI Conference being held in Los Angeles, CA, and virtually from October 3 – 4, 2023.
Netcapital to Present at the H.C. Wainwright Global Investment Conference on September 13, 2023BOSTON, MA – September 7, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (the “Company”), a digital private capital markets ecosystem, announced today that Jason Frishman, Founder of the Company’s wholly-owned subsidiary, Netcapital Funding Portal Inc.,will present at the H.C. Wainwright 25th Annual G…
Netcapital Hosts Reg A+ Offering by Thumzup MediaBOSTON, MA – August 9, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (the “Company”), a digital private capital markets ecosystem, today announced that its consulting group, Netcapital Advisors, is now hosting a Regulation A+ offering by Thumzup® Media on the netcapital.com website, representing its…
Netcapital Announces Revenue Growth of 55% for Fiscal Year 2023BOSTON, MA – July 26, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (the “Company”), a digital private capital markets ecosystem, today announced financial results for its fourth quarter and fiscal year 2023 ended April 30, 2023.
Netcapital Inc. Announces Closing of Public OfferingBOSTON, MA – July 24, 2023 / 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 1,725,000 shares of its common stock at a public offering price of $0.70 per sha…
Netcapital Inc. Announces Pricing of Public OfferingBOSTON, MA – July 19, 2023 / 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 1,725,000 shares of its common stock at a public offering price of $0.70 per share, for a…
Netcapital Inc. Announces Proposed Public Offering of Common StockBOSTON, MA – July 19, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (“Netcapital” or the “Company”), a digital private capital markets ecosystem, today announced that it intends to offer to sell shares of its common stock in an underwritten public offering. All of the shares of common stock are to be…
Netcapital Inc. Announces Closing of Registered Direct OfferingBOSTON, May 25, 2023 — Netcapital Inc. (Nasdaq: NCPL, NCPLW), (“Netcapital” or the “Company”), a digital private capital markets ecosystem, today announced the closing of the purchase and sale of an aggregate of 1,100,000 shares of its common stock, at a purchase price of $1.55 per share, in a regi…
Netcapital to Present at Singular Research’s Spring Select Webinar on May 25, 2023BOSTON, MA – May 24, 2023 – Netcapital Inc. (Nasdaq: NCPL, NCPLW) (the “Company”), a digital private capital markets ecosystem, announced today that the Company’s founder Jason Frishman will present at Singular Research’s Spring Select Webinar on Thursday, May 25, 2023 at 8:30 am PDT / 11:30 am ET.
Netcapital Inc. Announces Registered Direct OfferingBOSTON, May 23, 2023 — Netcapital Inc. (Nasdaq: NCPL, NCPLW), (“Netcapital” or the “Company”), a digital private capital markets ecosystem, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,100,000 shares of its common stock, at a purchase…
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.
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
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IN MAY, FORME ANNOUNCED A PARTNERSHIP WITH AETHOS, A HOTEL BRAND WITH LOCATIONS IN PORTUGAL, SPAIN AND ITALY THAT WILL PUT FORME’S CONNECTED FITNESS MIRRORS IN ALL OF ITS HOTELS AND MEMBER CLUBS.
ANNUALIZED RECURRING REVENUE PER HOUSEHOLD IN Q1 2023 MORE THAN TRIPLES YOY TO $1,650
LAST MONTH, THE COMPANY ANNOUNCED A DISTRIBUTION PARTNERSHIP WITH THE RISHER COMPANIES, A LEADING FITNESS CENTER CONSULTANT AND EQUIPMENT PROCUREMENT FIRM SERVICING OFFICE BUILDINGS, MULTIFAMILY PROPERTIES AND OTHER LARGE-SCALE CUSTOMERS – OPENING FORME UP TO A WORLDWIDE COMMERCIAL DISTRIBUTION CHANNEL
WITH A RECENT MASSIVE ACQUISITION, TRNR’S COMBINED BUSINESS IS ANTICIPATED TO GENERATE MORE THAN $20 MILLION IN REVENUE IN 2024 AND BE CASH FLOW POSITIVE
NEW COLLABORATION INCENTIVIZES U.S. CUSTOMERS TO SPEND FUNDS FROM HSA (HEALTH SAVINGS ACCOUNTS) AND FSA (FLEXIBLE SPENDING ACCOUNTS) PROGRAMS TO PURCHASE FORME’S PERSONAL TRAINING AND SMART HOME GYMS WITH PRE-TAX DOLLARS
We have a profile that we want you to research for Thursday’s session.
Earlier this year they completed a successful $12Mill IPO and listed on the Nasdaq.
Pull up TRNR right away.
More and more people are getting interested in personal fitness, especially after covid. One of the few positives to come out of the pandemic is that it got people to focus on their health and wellness. Exercise is a remedy for countless ailments, including mental health which also has a lot of focus on it right now.
This one has some recent major news worth researching.
The most important catalyst for this one is a brand new acquisition that should turn this company from an early stage growth company to a company that is doing $20Mill + in revenues and be profitable on a run rate basis by the end of 2024.
The CLMBR acquisition completely changes that valuation of the company and that is something that needs to be considered. We will be interested to see what the next few sets of financials will look like on paper. This could put a lot of new eyes on the company.
The acquisition is stock based and it is restricted. This means that the CLMBR management team rolled their equity into TRNR and have a vested interest in seeing the share price climb.
CLMBR has already sold a few thousand units to the public and are in select Planet Fitness and Crunch Fitness being considered for rollout to the entire portfolio.
TRNR is now a B2B and B2C company and their equipment is being installed in new developments and high end hotel chains and are even in a handful of the Four Seasons.
FORME EYES SUSTAINABLE GROWTH THROUGH CLMBR ACQUISITION USING A B2B/B2C MULTI-CHANNEL STRATEGY TO ‘AVOID MISTAKES OF PELOTON, OTHER STRUGGLING CONNECTED FITNESS COMPANIES’
OCT 13, 2023 9:00AM EDT. AUSTIN, TX / ACCESSWIRE / October 13, 2023 / It’s been a rough couple of years for connected fitness as the pandemic-era bubble burst leaving once shining growth stocks like Peloton grappling with waning demand and high production costs. However, some companies had the agility and foresight to pivot and diversify their revenue as consumer demand fell. Interactive Strength Inc. (NASDAQ:TRNR) – doing business as FORME – is one of those companies. The connected fitness company went public earlier this year and has announced significant updates on its B2B and B2C growth strategy.
The Company’s core product portfolio is sold as the brand FORME, offering premium connected fitness mirrors along with a differentiated offering through virtual one-on-one training sessions and guidance from highly qualified personal trainers. The company recently announced a transformative acquisition of CLMBR, the maker of the first-to-market connected vertical climber. The combined business is anticipated to generate more than $20 million in revenue in 2024 and be cashflow positive and adjusted EBITDA profitable potentially as early as the fourth quarter of 2024. The combined business is expected to be driven primarily by B2B revenue supported by the acquired sales and distribution partnership with WOODWAY, a leading domestic and international equipment supplier with a reputation for the highest quality equipment in the industry.
Trent Ward, Co-Founder and CEO of FORME, commented within the press release: “We believe this will be a transformational acquisition that can accelerate the Company’s commercialization path. We expect this transaction can help us achieve immediate scale across all of our cost centers, resulting in a high-growth, profitable platform that sells connected fitness equipment and digital fitness services across B2B and B2C channels. Our executive team has significant experience with M&A from my decade in finance, to the numerous acquisitions that our CTO, Deepak Mulchandani, effected while at Peloton, and of course, to the roll-up story at XPO, from where our CFO, Mike Madigan, joined. This transaction is a great example of checking all the boxes – accretive financials driven by cost synergies, strategic benefits such as gaining a very strong route to market with WOODWAY and shifting the business to be primarily B2B, and a complementary product with an attractive patent portfolio.”
The Rise And Fall Of Connected Home Fitness Equipment
After soaring to a $45 billion valuation in 2020, Peloton Interactive Inc. has been in an almost relentless freefall since 2021 as demand for its high-priced exercise equipment dropped after economies began reopening. The connected fitness brand had scaled its manufacturing so rapidly on the assumption that pandemic-era levels of demand would continue even after gyms reopened that it became bloated with high operation costs and unsold inventory. After burning cash for nine consecutive quarters, it finally reported positive free cash flow in its fourth quarter for the 2023 fiscal year, but Peloton CEO Barry McCarthy said the company didn’t expect cash flow to remain positive in a letter to shareholders last month.
As the recently appointed CEO attempts to turn the company around, Peloton is shifting its focus to a software-first business model. That includes an attempt to revive subscription revenue with a new low-cost monthly plan that lets subscribers access Peloton fitness classes from anywhere so they don’t have to buy into the expensive exercise equipment that’s suffered a major reputation hit after multiple recalls.
Similarly, Lululemon Atheltica Inc. bought Mirror, a connected fitness platform, in the summer of 2020, at the height of the pandemic-era boom for $500 million. The poorly-timed deal seems to have been a heavy burden on the company’s balance sheets ever since. This spring, the fitness brand took $443 million in impairment and other charges as a result of the declining value of the acquisition and there are now rumors that Lululemon is trying to sell the connected fitness acquisition.
Italy-based Technogym S.p.A. also faced a post-pandemic decline in home sales for its connected fitness equipment, with revenue from its B2C segment dropping 9% year-over-year in 2022. In the first half of 2023, B2C revenue declined another 4.6%.
But the key difference for the Italy-based connected fitness company is that it didn’t put all of its eggs in the B2C basket. Even at the height of the pandemic, home sales only made up 30% of Technogym’s total revenue. The rest of its earnings come from B2B sales to hotels, gyms, fitness clubs, health centers and other enterprise customers. So even as B2C revenue fell 4.6% in the first half of this year, the company still pulled off a 13.8% increase in revenue driven entirely by B2B sales which grew more than 20%.
FORME Reports Focus On Disciplined And Sustainable Growth In Connected Fitness
FORME is transitioning to a B2B-led business model similar to the one that helped Technogym weather the post-pandemic drop in demand for home fitness equipment. The connected strength company has developed a portfolio of premium connected hardware along with a unique virtual training membership that allows users to get live one-on-one training sessions through their Forme studio or through any mobile device.
The base monthly membership offers custom workouts and training programs along with on-demand content designed by a personal trainer. Then, members have the option to buy live one-on-one virtual sessions with that personal trainer.
The option to pay for a membership without having to buy the equipment upfront substantially lowers the barrier to entry that other brands face. Consumers can try out the membership first before committing to the FORME equipment – or they can stick with the mobile-only plan indefinitely.
But FORME isn’t planning to make the same mistakes that Peloton made by relying solely on B2C demand. Instead, the company’s commercialization strategy includes a pivot into the B2B space to further diversify its revenue streams.
In May, FORME announced a partnership with Aethos, a hotel brand with locations in Portugal, Spain and Italy that will put Forme’s connected fitness mirrors in all of its hotels and member clubs.
Last month, the company announced a distribution partnership with The Risher Companies, a leading fitness center consultant and equipment procurement firm servicing office buildings, multifamily properties and other large-scale customers – opening FORME up to a worldwide commercial distribution channel.
Now, with the acquisition of CLMBR complete, the company plans to expand its B2B vertical while creating cross-selling opportunities in its existing B2C vertical as it gains access to the target company’s customer base and product portfolio.
Mr. Ward, CEO, commented on the transaction: “We believe this will be a transformational acquisition that can accelerate the Company’s commercialization path. Further, we believe the combination of these businesses can create tremendous value for all of our shareholders. We expect this transaction can help us achieve immediate scale across all of our cost centers, resulting in a high-growth, profitable platform that sells connected fitness equipment and digital fitness services across B2B and B2C channels.”
To watch a video with the product in action, CLICK HERE
Notable hedge fund manager Bradley Wickens made a series of insider purchases adding to his position of more than a 10% holder in TRNR earlier this year. Wickens, a UK-based hedge fund manager and founder of Broad Reach Investment Management, started with a 10% ownership stake in TRNR. Wickens has made a series of share purchases since Interactive Strength’s IPO, and he increased his number of TRNR shares to over 1.7Mill this year all between 3.50 and 7.50.
Right now it is sitting under 1.10 and Mr. Wickens continues to hold his position.
INTERACTIVE STRENGTH, INC. D/B/A FORME ANNOUNCES STRATEGIC PARTNERSHIP WITH HSA/FSA PAYMENT PROVIDER TRUEMED
Collaboration incentivizes U.S. customers to spend funds from HSA (Health Savings Accounts) and FSA (Flexible Spending Accounts) programs to purchase FORME’s personal training and smart home gyms with pre-tax dollars
Partnership enhances FORME’s B2C positioning as a growth driver to complement the B2B initiative of acquiring CLMBR that was announced on October 11
AUSTIN, TX, Oct. 13, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – Interactive Strength Inc. d/b/a FORME (Nasdaq: TRNR), maker of premium smart home gyms and provider of virtual personal training services, announces a strategic partnership with Truemed (True Medicine), a leading healthcare payment provider. This pioneering collaboration enables U.S. customers to spend funds from their HSA (Health Savings Account) and FSA (Flexible Spending Account) programs to access FORME’s cutting-edge wellness solutions, resulting in average after-tax savings between 30% and 40%.
With a shared commitment to help customers invest in their health and wellness, FORME and Truemed have joined forces to provide aligned incentives and access to expert trainers and premium equipment. Users can now conveniently purchase FORME’s innovative smart gym, the Lift, or 1:1 personal training from FORME’s website at checkout, and existing FORME members could potentially benefit from reimbursement for purchases.
Trent Ward, Co-founder and CEO of FORME, commented: “This collaboration represents an important milestone for FORME, as the partnership materially improves the affordability of our offerings, by helping customers benefit from after-tax savings through HSA and FSA programs. Exercise is medicine and I am inspired by the Truemed team’s tireless advocacy of supporting appropriate incentives to help our society achieve and maintain their health. We have doubled down on keeping people healthy through our pending acquisition of CLMBR, and having partners like Truemed makes a big difference.”
How Existing FORME Members Can Benefit: Members who already have a FORME membership can benefit from the Truemed partnership and get reimbursed for future payments for your eligible membership purchases. By using their HSA and FSA funds for FORME membership or personal training, current members are investing in their well-being while enjoying the convenience of a single, integrated payment solution.
How New FORME Members Can Participate: Customers purchasing FORME fitness equipment, such as the Lift, should add desired products to the cart, select Truemed as your payment option at checkout, enter your HSA or FSA debit card details, and complete a brief health survey to determine your eligibility. Once your eligibility is approved, you are all set. Should you prefer to checkout using a credit card and reimburse later, follow the on-screen instructions.
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 consiousness among youth about healthy lifestyle
Growth in government initiatives regarding healthy and fit lifestyles
INTERACTIVE STRENGTH INC. (NASDAQ: TRNR D/B/A “FORME”) ANNOUNCES NON-BINDING LETTER OF INTENT AND EXCLUSIVITY AGREEMENT TO ACQUIRE A CONNECTED FITNESS EQUIPMENT BUSINESS
The combined Company is projected to generate more than $25 million in gross revenue in 2024 and be cashflow positive and adjusted EBITDA profitable by the fourth quarter of 2024
It is currently anticipated that all of the equity of the target company will be exchanged for TRNR equity and be subject to a “lock-up” untilthe end of October 2024, similar to pre-IPO shareholders
The transaction is expected to closeas early as the fourth quarter of 2023
AUSTIN, TX, Aug. 15, 2023 (GLOBE NEWSWIRE) — via NewMediaWire — Interactive Strength Inc.(Nasdaq: TRNR d/b/a “FORME”), maker of premium smart home gyms and provider of virtual personal training services, is excited to announce that it has entered into a non-binding letter of intent and exclusivity agreement to acquire a connected fitness equipment business.
The potential transaction, if consummated, is expected to accelerate FORME’s commercialization path, result in immediate scale across all functions and create a high-growth and profitable platform that sells connected fitness equipment and digital fitness services across B2B and B2C channels.
Based on internal management projections of the target, the 2023 combined gross revenues are projected to exceed $10 million and 2024 combined gross revenues are projected to exceed $25 million. By the fourth quarter of 2024, the combined business is projected to be cashflow positive and achieve positive adjusted EBITDA, based on identified cost synergies. The proposed acquisition is currently expected to be completed as early as the fourth quarter of 2023.
“We believe this will be a transformational acquisition that can accelerate our commercialization path. Further we believe the combination of these businesses will create tremendous value for both groups of shareholders,” said Trent Ward, co-founder and CEO of FORME. “We expect this transaction can help us achieve immediate scale across all of our cost centers, resulting in a high-growth, profitable platform that sells connected fitness equipment and digital fitness services across B2B and B2C channels.”
This strategic move is also expected to provide FORME and the target company with enhanced cross-selling opportunities and improved penetration into new end markets.
“We are excited about what we are seeing in the B2B channel in our own business. In fact, the strength of the performance in the B2B channel, as well as our belief that the FORME business would benefit from further investment in this area, were key reasons for our interest in the potential acquisition. This transaction sets the stage for FORME to become an industry leader across a range of modalities.”
FORME’s due diligence review of the target acquisition has already commenced, and upon satisfactory completion, the Company intends to proceed towards executing a definitive acquisition agreement and closing the transaction as soon as all closing conditions are met by all parties involved.
Proposed Transaction Highlights:
The proposed acquisition is expected to yield several strategic and financial benefits, positioning the combined entity for further growth:
Rationale
Provides immediate scale in all functions (Sales, Engineering, Logistics, Supply Chain, Corporate Overhead)
Generates material and near-term cashflow for FORME
Diversifies revenue (products and channels), with significant growth in B2B channel
Opportunity for strong B2B distribution partner for FORME hardware products
Solidifies position as the premium platform in the Connected fitness industry
Pro forma financials
Combined Gross revenues in 2023 are projected to exceed $10 million
Combined Gross revenues in 2024 are projected to exceed $25 million
Cashflow positive and adjusted EBITDA positive by the fourth quarter of 2024
Consideration
All of the equity of the target company is anticipated to be exchanged for TRNR equity at close of transaction, and with the same shareholder “lock-up” as pre-IPO shareholders (end of October 2024)
Earn-out potential for 2024 paid in TRNR equity, with Enterprise Value / 2024 Gross Revenue multiple of approximately 1.2x remaining constant
Minimal cash for working capital
Assumption of target debt
Valuation
Approximately 1.2x Enterprise Value / 2024 Gross Revenues
Between 5x and 6x Enterprise Value / EBITDA pro-forma for projected synergies
Timing
Close as early as the fourth quarter of 2023
The letter of intent described above is non-binding, and as such, there can be no assurance that the Company will enter into a definitive acquisition agreement or that the terms of any such agreement will not change, or that the proposed acquisition will be consummated at all.
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. MULCHANDANI CHIEF 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.
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This is another company that we have never looked at before on this newsletter before.
Pull up TLSA right away.
Historically, monoclonal antibodies, such as blockbuster drug, Humira®, have performed as the best selling drugs in the world. Targeting across multi-indications such as autoimmune disorders and degenerative diseases, these drugs have multi-billion dollar blockbuster potential.
To this day, there is no drug on the market that is a fully human, anti-CD3 monoclonal antibody…and Tiziana Life Sciences (NASDAQ: TLSA) is developing the potential to treat patients in need that suffer from secondary progressive multiple sclerosis.
Tiziana Life Sciences (NASDAQ: TLSA) is a clinical stage biotechnology company that specializes in developing transformative therapies for neurodegenerative and lung diseases. The Company’s clinical pipeline includes drug assets for Secondary Progressive Multiple Sclerosis, ALS, Alzheimer’s, Crohn’s Disease and KRAS+ NSCLC.
Tiziana is led by a team of highly qualified executives with extensive drug development and commercialization experience.The Company is developing transformational formulation technologies, enabling it to switch from traditional routes to alternative routes of immunotherapy to facilitate local sites of action.
INVESTMENT HIGHLIGHTS:
A revolutionary platform:TLSA is first in class, switching from uncomfortable antibody injections to revolutionary nasal and oral methods of delivery. The benefits of switching to this unique methodology are increased patient compliance, minimized side effects, and anticipated lower cost of goods and administration.
Multiple Indications: TLSA’s focus is across multiple indications such as neurodegenerative diseases like Multiple Sclerosis as well as lung diseases. Similar monoclonal antibody drugs, such as Humira®, have performed extraordinarily well with approximately $200 billion dollars in revenue.
Monoclonal Antibodies: Recently, Provention Bio, a competitor for TLSA, was acquired by Sanofi SA (NASDAQ: SNY) for $2.9 billion. Tiziana stands out from the competition as their drug, foralumab, is administered nasally and is fully human.
Foralumab: Tiziana’s clinical drug, foralumab, a fully human anti-CD3 monoclonal antibody for the treatment of neurodegenerative diseases, works with novel technology to be delivered nasally. This allows the drug to bypass and potentially prevent the toxicities that may be present with non-fully human antibodies making it a revolutionary and very exciting clinical development.
Market Potential: Neurodegenerative diseases are rising which contributes to a growing market market projected to reach USD 53 Billion by 2030 and grow steadily at a CAGR of 3.2%. Beyond that, competitors are catching the attention of big pharma.
Unmet Need: TLSA is dedicated to developing drugs to service diseases that currently have no cure. The company’s clinical trial is across multiple neurodegenerative disease, autoimmune, and lung disease indications.
FORALUMAB (TZLS-401)
Foralumab is a fully human anti-CD3 monoclonal antibody (mAb) for the treatment of Crohn’ s and neurodegenerative diseases. We have completed two Phase 1 clinical trials: one for progressive MS indication with nasal administration and the other for Crohn’s disease indication, with enteric coated capsules administered orally. We also completed a Phase 2 trial treating mild to moderate non-hospitalized COVID-19 patients in Brazil with intranasal foralumab with positive results (Moreira et al., 2021)*. Currently, two secondary progressive MS patients are being treated at Brigham and Women’s Hospital, Boston MA, with intranasal foralumab under Expanded Access INDs with signs of clinical benefit, we are expecting 12-month data from EA#1 and 6-month data from EA#2 in 4Q-2022. Patient enrolment for the Intermediate-size patient population expanded program has begun. Foralumab has demonstrated ability to activate regulatory T cells that systemically circulate to elicit targeted immunomodulation providing therapeutic benefit to patients.
Tiziana has recently submitted a patent application on potential use of Foralumab, to improve success of chimeric antigen receptor T cells (CAR-T) therapy for cancer and other human diseases. The patent application covers inventions related to improving CAR-T expansion and/or survival. Foralumab administered alone or co-administered in combination with co-stimulatory molecules, such as an anti-IL-6 receptor monoclonal antibody, an anti-CD28 monoclonal antibody or specific inhibitors of signalling pathways of phosphatidylinositol 3-kinase (PI3K), protein kinase B (AKT), or mammalian target to improve success of CAR-T therapy.
* Moreira, T. G., et al. (2021) Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study. Front Immunol 12, 709861
MILCICLIB (TZLS-201)
Milciclib is a potent, small molecule inhibitor of multiple cyclin-dependent kinases (CDKs), tropomycinreceptor kinases and Src family kinases controlling cell growth and malignant progression of cancer. Milciclib has demonstrated safety and tolerability in 316 patients with advanced solid cancers in Phase 1 and 2 studies and also exhibited positive clinical responses. In two, successfully completed, Phase 2 thymic cancer trials, Milciclib successfully increased overall survival and met both primary and secondary endpoints.
In July and September 2019, we reported positive Phase 2a safety, tolerability and efficacy data of Milciclib as a monotherapy in 28 patients with advanced HCC. The results, presented at ASCO2020, warrants further clinical development. Strong genetic and pharmacological evidence suggests that pan-CDKs inhibitors might have potential to suppress the multiple tumorigenic pathways that are activated due to activation of KRAS gene. Clinical data from a Phase I dose-escalation study with combination of milciclib with gemcitabine showed significant disease stabilization and suggested that milciclib can reverse gemcitabine-resistance in NSCLC refractory solid tumors. The clinical response in the NSCLC patient was particularly very promising. Company is exploring the combination of milciclib and gemcitabine in NSCLC subjects with pan KRAS-positive mutations.
TZLS-501
Tiziana’s Anti IL-6R mAb (TZLS-501), a fully human mAb binds to both membrane-bound and soluble forms of IL-6R, an inflammatory cytokine driving chronic inflammation associated with autoimmune disease and cancer, reducing circulating levels of the IL-6 cytokine. Anti-IL-6R antibody can potentially be used in combination with Foralumab or other anti-inflammatory and anti-infective agents as therapy for idiopathic pulmonary fibrosis (IPF), acute respiratory distress syndrome (ARDS), multiple myeloma, arthritis, lupus and oncology indications. Excessive production of IL-6 is regarded as a key driver of chronic inflammation and is believed to be associated with severe lung damage and chronic fibrosis observed with acute and chronic respiratory illness.
The Company is scaling GMP manufacturing of its anti-IL-6R mAb concurrently with developing a hand-held nebulizer technology for direct delivery of the antibody into the for treatment of patients with IPF, a rare disease indication.
TIZIANA ANNOUNCES POSITIVE QUALITATIVE SIX-MONTH PET SCAN RESULTS WITH INTRANASAL FORALUMAB TREATING MULTIPLE SCLEROSIS PATIENTS DIAGNOSED WITH NON-ACTIVE SECONDARY PROGRESSIVE MS (NA-SPMS)
OCT 13, 2023 7:00AM EDT
Five out of six patients in FDA authorized Expanded Access Program are showing a qualitative reduction in microglia activation (a key biomarker being observed)
Foralumab to advance into Phase 2 human clinical trials using the world’s only fully human intranasal anti-CD3 monoclonal antibody
Phase 2 trial screening for na-SPMS to begin in November 2023
NEW YORK, Oct. 13, 2023 (GLOBE NEWSWIRE) — Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that a reduction in activated microglia, as seen in six-month Positron Emission Tomography (PET) scans, has now been observed in a total of five of the six patients with non-active secondary-progressive multiple sclerosis (na-SPMS) treated with intranasal foralumab in its Expanded Access Program (EAP). Activated microglia are believed to play a prominent role in the pathogenesis of neuroinflammatory and neurodegenerative diseases including multiple sclerosis, Alzheimer’s disease, and amyotrophic lateral sclerosis, or ALS.
Tarun Singhal, M.B.B.S., M.D., Director of the PET Imaging Program in Neurologic Diseases, associate neurologist and nuclear medicine physician at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System, and Assistant Professor of Neurology at Harvard Medical School, commented, “Upon review of the baseline and six-month PET scans of the latest cohort of four Expanded Access patients, three out of the four scans suggested a qualitative reduction in the microglial PET signal. When combined with my assessment of the first two Expanded Access patients at six-months, five of the six suggested a reduction in qualitative microglial PET signal. An example of this can be seen in the graphic below, titled, “Figure 1”, showing the deactivation of this signal in patient EA6. This is promising from an imaging standpoint, and further studies are needed to confirm these findings using additional quantitative approaches.”
Howard L. Weiner, M.D., Chairman of Tiziana’s Scientific Advisory Board and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital added, “With six patients now dosed in our na-SPMS EA program, I feel that Dr. Singhal’s readout of the six-month PET scans strongly supports our previously announced 3-month clinical findings.”
Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences commented, “I believe that the six-month qualitative na-SPMS PET readout by Dr. Singhal is very encouraging and will enable us to rapidly advance foralumab in Phase 2a testing to address patients afflicted with this devasting disease who currently have no FDA-approved treatments available.”
Figure 1.
About Foralumab
Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial is expected to start screening in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.1,2
Executive ChairmanMr Cerrone has a successful track record and extensive experience in the financing and restructuring of micro-cap biotechnology companies. He has founded nine biotechnology companies in oncology, infectious diseases and molecular diagnostics, and has taken six of these companies to the NASDAQ Market and one to the AIM Market in London. Mr Cerrone co-founded Trovagene, Inc. (NASDAQ: TROV), a molecular diagnostic company and served as its Co-Chairman; he was a co-founder and served as Chairman of both Synergy Pharmaceuticals, Inc. (NASDAQ: SGYP) and Callisto Pharmaceuticals, Inc. (OTCMKTS: CLSP), and was a Director of and led the restructuring of Siga Technologies, Inc. (NASDAQ: SIGA). Mr Cerrone also co-founded FermaVir Pharmaceuticals, Inc. and served as Chairman of the Board until its merger in September 2007 with Inhibitex, Inc. Mr Cerrone served as a director of Inhibitex, Inc. until its US$2.5bn sale to Bristol Myers Squibb Co in 2012. Mr Cerrone is the Executive Chairman and Co-Founder of Gensignia Life Sciences, Inc., a molecular diagnostics company focused on oncology using microRNA technology; Chairman and Founder of Tiziana Life Sciences plc (AIM: TILS) an oncology focused therapeutics company; Chairman and Co-Founder of Rasna Therapeutics Limited, a company focused on the development of therapeutics for leukaemias; Co-Founder of ContraVir Pharmaceuticals, Inc. (Nasdaq: CTRV); and founder of BioVitas Capital Ltd.
MATTHEW W DAVIS, MD, RPH
Chief Medical Officer and acting Chief Scientific OfficerDr. Davis has extensive experience in new drug application, or NDA, and biologic license application, or BLA, FDA approvals and device clearances. Notable approved brands that Dr. Davis has worked on include Lidoderm®, Sculptra®, Colcrys® and most recently QWO®. Dr. Davis previously served as Chief Scientific Officer and Chief Medical Officer at Endo Pharmaceuticals where he restructured the R&D department and collaborated to obtain BLA approval for QWO®. Additionally, Dr. Davis was Chief Medical Officer for Lupin Inc. and URL Pharma, Inc. where he spearheaded three NDA approvals and was the inventor on all 17 Orange Book listed patents for Colcrys®. He also was on the executive team that sold URL Pharma to Takeda Pharmaceutical Company for approximately $800M combined with over $1B in performance-based contingent earn out payments. Dr. Davis matriculated to the University of Pennsylvania as an undergraduate. He received his Pharmacy Degree from Temple University and his Medical Degree from the Medical College of Pennsylvania. Dr. Davis undertook his surgical training at Brown University and his Urology training at Washington Hospital Center
KEEREN SHAH
Chief Financial OfficerKeeren Shah serves as our Chief Financial Officer. Ms. Shah currently also serves as the Chief Financial Officer of OKYO Pharma Ltd, Accustem Sciences Limited and Rasna Therapeutics Inc., having previously served as the Group Financial Controller for all businesses from June 2016 to July 2020. Prior to joining the Company, Ms. Shah spent 10 years at Visa, Inc. as a Senior Leader in its finance team where she was responsible for key financial controller activities, financial planning and analysis, and core processes as well as leading and participating in key transformation programmes and Visa Inc.’s initial public offering. Before joining Visa, Ms. Shah also held a variety of finance positions at other leading companies including Arthur Andersen and BBC Worldwide. She holds a Bachelor of arts with honors in Economics and is a member of the Chartered Institute of Management Accountants.
SINCERELY,
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CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS TOTALED $227.5 MILLION AS OF JUNE 30, 2023
ATAI OFFERS A DIVERSE PIPELINE OF DRUGS AND A FOCUS ON COMPOUNDS WITH PRIOR EVIDENCE IN HUMANS, UPCOMING INFLECTION POINTS (MULTIPLE PHASE 1 AND PHASE 2 PROOF-OF-CONCEPT TRIAL READOUTS ARE EXPECTED IN THE NEXT TWO YEARS)
WITH PROMINENT BACKING FROM VENTURE CAPITALISTS, INCLUDING BILLIONAIRES PETER THIEL AND CHRISTIAN ANGERMAYER, ATAI LIFE SCIENCES RANKS AMONG THE BIGGEST BIOTECH STOCKS FOCUSED ON THE DEVELOPMENT OF MENTAL HEALTH TREATMENTS
We have another profile for you to research for Friday’s session.
Pull up ATAI Immediately
ATAI is a clinical-stage biotechnology company pioneering the development of novel and effective mental health therapeutics. Founded in 2018 as a response to the significant unmet need and lack of innovation in neuropsychiatry, atai is dedicated to developing compounds with prior evidence in humans, particularly those that have been overlooked and not rigorously studied, such as psychedelics.
ATAI is developing medicines to treat large and underserved patient populations, including those living with cognitive decline associated with schizophrenia, anxiety, depression and substance use disorders.
ATAI’s cash position is among the strongest in the psychedelic medicine space, with approximately $273M (as of December 31, 2022) and access to up to an additional $160M via term loan facility providing an anticipated runway into H1 2026.
After watching loved ones struggle with mental health issues, Brand realized that patients across the world were not getting the treatments they needed.
WITH PROMINENT BACKING FROM VENTURE CAPITALISTS, INCLUDING BILLIONAIRES PETER THIEL AND CHRISTIAN ANGERMAYER, ATAI LIFE SCIENCES RANKS AMONG THE BIGGEST BIOTECH STOCKS FOCUSED ON THE DEVELOPMENT OF MENTAL HEALTH TREATMENTS.
atai Life Sciences takes a holistic approach to “treat the patient, not the condition.” A leader in the mental health space, the company comes with experience and history of psychedelics, and is equipped to deliver the next generation of mental health medicines.
MAJOR CATALYSTS
Large Market Potential: Mental health disorders are one of the largest global health burdens; global market size in mental health was $380Bn in 2020 and is expected to grow to $509bn by 2028.
Clear Objective: atai’s objective is to achieve clinically meaningful and sustained behavioral change in mental health patients by developing rapid-acting and patient-centric pharmaceutical and digital treatment solutions.
Large Unmet Clinical Indications: atai’s clinical pipeline is currently in development to treat large and underserved patient populations, including those living with cognitive decline associated with schizophrenia, treatment-resistant depression, anxiety, and substance use disorders
Multiple Shots on Goal: atai has 8 clinical stage drug development programs with a focus on compound classes with prior evidence in humans. Its diversified platform approach helps avoid binary risk and optimizes likelihood of success.
Significant Catalyst Event Potential: Company expects to deliver multiple R&D milestones anticipated across key clinical programs over next 2 years.
Strong Cash Position: Cash, cash equivalents and short-term investments totaled $227.5 million as of June 30, 2023
Valuation Imbalance Opportunity: Market cap of ~$295M as of April 26 2023 despite cash balance, cash equivalents and short-term investments totaling $227.5 million. $80M stake in COMPASS Pathways as of March 17, 2023 and multiple clinical stage drug candidates in development
Strong Market Validation: Validation of atai’s operating model and ability to capture value: IPO of COMPASS Pathways in 2020 and licensing deal between Otsuka and atai subsidiary Perception Neuroscience in 2021.
Compassionate Vision: To heal mental health disorders so that everyone everywhere can live a more fulfilled life.
ATAI TACKLES THE MENTAL HEALTH CRISIS WITH A UNIQUE DE-RISKING APPROACH FOCUSED ON A DIVERSE PIPELINE OF COMPOUNDS WITH PRIOR EVIDENCE IN HUMANS
By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines to achieve clinically meaningful and sustained behavioral change in mental health patients.
Key Strategic Pillars
Rapid acting intervention: 1st, 2nd and 3rd generation compounds with the potential to show strong behavioral plasticity, rapid onset and more durable effects
Ongoing psychological support: Digital therapeutics deliver care to patients before, during and/or after initial treatment intervention
Precision mental health: The identification of patient sub-types using biological and digital biomarkers
You can read more about the company’s programs HERE.
ATAI’S DIVERSE CLINICAL PIPELINE GIVES MULTIPLE SHOTS ON GOAL WITH NUMEROUS UPCOMING R&D MILESTONES
ATAI’s pipeline includes 8 clinical stage drug development programs with a focus on compound classes with prior evidence in humans; this approach involves a pharmacologically diverse pipeline to avoid binary risk while optimizing likelihood of success.
The Potential of Psychedelics
Psilocybin (a hallucinogenic compound) and DMT (a powerful and rapid acting psychedelic present in ayahuasca) have been highly buzzed about in the mental health arena for their potential as a long-lasting, highly effective treatment.
ATAI Life Sciences is embarking on the study of these and other drugs for their potential to effectively and rapidly treat many mental health disorders that are resistant to treatment.
ATAI IS A LEADER IN THE MENTAL HEALTH PHARMACEUTICAL MARKET AS THE COMPANY WORKS TO DELIVER ON ITS CLINICAL STRATEGIES WITH IMMENSE MARKET POTENTIAL.
Today, the global mental health market size has reached US$ 380 Billion. Looking forward, IMARC Group expects the market to reach $509 Billion by 2028, exhibiting a growth rate (CAGR) of 3.4% between 2023-2028.
The growing, underserved mental health space leads us to atai Life Sciences. The company has an innovative approach to solve the real and growing problem of mental health disorders with a unique digital approach.
Addressing Depression, Anxiety, Addiction, and other Mental Health Disorders with a compassionate mission. atai is zooming in on robust categories in the mental health treatment market.
SCHIZOPHRENIA
Problem: Cognitive impairment is a core feature of schizophrenia for the 24m people who live with it. 98% of patients with schizophrenia perform worse on cognitive tests than expected. There are no FDA approved therapies for Cognitive Impairment Associated with Schizophrenia (CIAS).
Atai’s answer: atai is investigating RL-007, a novel compound that has shown pro-cognitive effects in numerous Phase 1 and 2 studies.
ANXIETY
Problem: Anxiety disorders are the most comment mental health concern in the United States and not only do less than half of those affected receive treatment, but currently approved medications come with significant side effects and/or risk of dependence.
Atai’s answer: atai is investigating deuterated etifoxine, a patent protected version of etifoxine, a drug approved for anxiety in more than 40 countries with benzodiazepine-like effects but without the sedative effects and addictive potential.
DEPRESSION
Problem: Depression affects more than 300m people and is the 2nd leading cause of disability worldwide. Only about 1/3 of patients respond to existing treatments and standard-of-care drugs like SSRIs come with significant side effects ranging from weight gain to suicidality.
Atai’s answer 1: COMP360 (patented protected synthetic psilocybin) is in late-stage studies for treatment-resistant depression.
Atai’s answer 2: atai is studying VLS-01 (oral thin film DMT) for treatment-resistant depression.
SUBSTANCE USE DISORDER
Problem: Over 20m people live with a substance use disorder (SUD) in the US. Since the drug epidemic started in 1999, there have been over 900,000 overdose fatalities. For an already vulnerable population, COVID-19 severely exacerbated the crisis for those with a SUD. Drug overdose deaths shot up ~30% with close to 93,000 deaths in 2020, nearly 70,000 of which involved opioids. With only 2 FDA approved treatments for OUD, options are limited, and relapse rates are as high as 75%.
Atai’s answer: atai is studying DMX-1002, an oral formulation of ibogaine, a naturally occurring psychedelic compound isolated from a West African shrub. In uncontrolled studies, Ibogaine has demonstrated rapid and sustained efficacy for OUD.
atai Life Sciences Investment Thesis: A Uniquely Positioned Leader In Mental Health Drug Development with Compelling De-risked Approach and Trading Below Cash
Atai has a market cap of ~$207M as of March 17, 2023 despite cash balance of $304m as of September 30, 2022, an aprox. $80M stake in COMPASS Pathways as of March 17, 2023 and multiple clinical stage drug candidates in development that tackle the mental health crisis
ATAI LIFE SCIENCES REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS, AND ANNOUNCES CLINICAL DATA FROM THE PHASE 1 STUDY OF DMX-1002 (IBOGAINE)
PUBLISHED
AUG 10, 2023 6:59AM EDT
Advanced multiple clinical stage assets in development, including the on-going Phase 2b study of RL-007 in patients with Cognitive Impairment Associated with Schizophrenia
DMX-1002 (Ibogaine) Phase 1 results enable discussions with regulatory authorities to assess progressing into proof-of-concept study in patients with Opioid Use Disorder
The Company’s $227M cash position and committed term loan funding is expected to fund operations into 1H 2026
NEW YORK and BERLIN, Aug. 10, 2023 (GLOBE NEWSWIRE) — atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, reported second quarter 2023 financial results and provided corporate updates.
“We continue to focus on our vision to heal mental health disorders so that everyone, everywhere can live a more fulfilled life,” said Florian Brand, CEO and Co-Founder of atai. “Looking ahead to the second half of 2023 and beyond, we believe we are well positioned to continue advancing our key clinical programs. We are especially encouraged by the progress our team has made in advancing RL-007 in the on-going randomized, placebo-controlled Phase 2b study as well as further evaluating VLS-01 in Part 3 of the on-going Phase 1 study. Today, we are pleased to report data from the Phase 1 trial of DMX-1002 (Ibogaine).”
“Current treatment options for Opioid Use Disorder (OUD) patients are not highly effective, with approximately 75% of patients undergoing therapy experiencing relapse within one year,” said Srinivas Rao, CSO and Co-Founder. “DMX-1002 has the potential to be a disease modifying treatment for this vulnerable patient population seeking to end their intractable cycle of drug dependence.”
“The results from this trial are consistent with the known side-effect profile of ibogaine, the active moiety in DMX-1002,” said Dr. Marek Malik, Professor Emeritus of Cardiac Electrophysiology, Imperial College, London and clinical advisor for the DMX-1002 development program. “Ibogaine is known to cause prolongation of the electrocardiographic QT interval. Drug-induced prolongation of the QT interval is a phenomenon that has been, with many but not all drugs, associated with cardiac arrhythmias. The QT-related side effect of ibogaine is anticipated to be manageable in a controlled setting with appropriate cardiac monitoring and safety protocols. In severe patient populations, like those living with OUD, ibogaine treatment administered in such a setting has a potential to be a paradigm shift for patients.”
DMX-1002 (Ibogaine) Phase 1 Results and Program Update:
Today, the company announced results from the Phase 1 study of DMX-1002, a cholinergic, glutamatergic and monoaminergic receptor modulator being developed for the treatment of OUD.
The single-blinded Phase 1 study assessed the safety, tolerability and pharmacokinetics of single-ascending doses of DMX-1002 in healthy volunteers. Oral doses of 3 mg/kg, 6 mg/kg & 9 mg/kg were evaluated in 20 participants. Results of the Phase 1 trial demonstrated that oral doses of DMX-1002 at 9 mg/kg achieved plasma concentrations in line with those described in previous studies1,2 in which subjects reported psychedelic experiences and obtained therapeutic benefit in OUD.
The treatment-related adverse events (AEs) were similar to those observed in prior trials of DMX-1002, and nearly all (>94%) were rated mild-to-moderate in severity. There were no serious adverse events reported.
In one of the two participants who received 9 mg/kg of DMX-1002, QTc prolongation reached levels near those seen at the 10 mg/kg dose in the published literature3 (median change: 95ms). In this participant, a QTcF prolongation of 90-94ms was observed with a QTcF interval of 493-501ms. The patient was asymptomatic, with no cardiac arrythmias, and the QTc change resolved without intervention or sequalae.
During the study the company closely worked with cardiology experts who concluded that while QT prolongation of this order is a clinical risk, monitoring can help mitigate the risk to ensure the safety of patients, especially in a medical setting. The benefit of the drug will need to be defined in efficacy trials and will need to be weighed against the risks that have been defined.
The company plans to engage regulatory authorities to assess progressing DMX-1002 into an efficacy study in patients with OUD.
Recent Developments:
RL-007 (Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia)
The on-going Phase 2b study is a randomized, placebo-controlled, double-blind, study of 6 weeks duration evaluating 20mg and 40mg of RL-007 vs placebo.
The primary endpoint of the study is the change from baseline in the MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score, a well-established regulatory endpoint.
The company expects to report topline results from this study in the 2nd half of 2024.
VLS-01 (N,N-dimethyltryptamine [DMT] for Treatment-Resistant Depression (“TRD”))
The on-going Phase 1 study is designed to evaluate the safety, tolerability, PK and PD of VLS-01 delivered by intravenous (IV) infusion and using our proprietary oral transmucosal film (OTF) formulation.
In Part 1 (IV) and Part 2 (OTF), VLS-01 was well-tolerated, with no dose-limiting toxicity and a favorable safety profile. VLS-01 produced generally dose-dependent increases in exposure, and administration resulted in subjective psychedelic experiences in the majority of subjects. Part 3 is exploring further optimization of PK and PD of our proprietary OTF formulation, including further dose ranging.
The company expects to report additional clinical data in Q3 2023.
PCN-101 (R-Ketamine for TRD)
The company recently announced completion of the Phase 1 open-label bridging study designed to assess the safety, tolerability, and pharmacokinetic profile of 60mg, 90mg and 120mg of PCN-101 delivered subcutaneously (SQ) as compared to 60mg of PCN-101 delivered IV.
Pharmacokinetic (PK) analysis indicates that 120mg of PCN-101 delivered SQ resulted in an approximate doubling of drug exposure (AUC) while maintaining approximately the same maximum concentration (Cmax) as the 60mg IV dose.
At the highest SQ dose of 120mg, rates of sedation (defined as MOAA/S score 4 and change from baseline >0) were each 14%. Overall, the data support testing the concept of at-home use of PCN-101 in future studies.
The company continues to work with Perception Neuroscience to explore strategic partnership options.
EMP-01 (3,4-methylenedioxy-methamphetamine [MDMA] derivative for Post-Traumatic Stress Disorder (“PTSD”))
The Phase 1 study is designed to evaluate the safety and tolerability of single-ascending doses of EMP-01 in healthy adult participants.
Enrollment has been recently completed and the company expects to report initial clinical data in Q4 2023.
COMP360 (Psilocybin Therapy for TRD, Anorexia Nervosa and PTSD)
COMPASS Pathways is currently conducting a Phase 3 program composed of two pivotal trials, each of which will have a long-term follow-up component. Topline data from Pivotal Trial 1 (COMP005) is expected in the summer 2024. The primary endpoint in both pivotal trials is the change from baseline in MADRS total score at week 6.
The American Medical Association recently released the language of its new Current Procedural Terminology (CPT®) III code for Continuous In-Person Monitoring and Intervention During Psychedelic Medication Therapy. The code will go into effect and will be published in the CPT manual on January 1, 2024. Once effective, the new code will provide a mechanism to track and report the delivery of psychedelic treatments.
Consolidated Financial Results
Cash, Cash Equivalents, and Short-term investments: Cash, cash equivalents and short-term investments totaled $227.5 million as of June 30, 2023, compared to $273.1 million as of December 31, 2022. The decrease of $45.6 million was primarily driven by net cash used in operating activities of $43.7 million and $3.0 million of loans to related parties. The Company expects its cash position and committed term loan funding will be sufficient to fund operations into 1H 2026.
Research and Development (R&D) Expenses: Research and development expenses for the three months ended June 30, 2023 were $15.5 million, including $3.3 million of stock-based compensation compared to $17.9 million, including $3.9 million of stock-based compensation for the three months ended June 30, 2022. The decrease of $2.4 million was primarily attributable to a $1.8 milliondecrease of costs related to our non-clinical activities and $0.6 million decrease in contract research organization expenses.
General and Administrative (G&A) Expenses: General and administrative expenses were $16.6 million, including $5.4 million of stock-based compensation for the three months ended June 30, 2023compared to $17.2 million, including $5.7 million of stock-based compensation for the three months ended June 30, 2022. The decrease of $0.6 million was largely attributable to a decrease of $0.4 million in personnel related costs and $0.2 million net decrease in public company administrative costs.
Net Loss: Net loss attributable to shareholders for the three months ended June 30, 2023, was $33.1 million (including non-cash share-based compensation expense of $8.8 million) as compared to $36.6 million (including non-cash share-based compensation expense of $9.5 million) for the comparable prior year period.
Florian Brand is the co-founder and Chief Executive Officer of atai Life Sciences. Prior to joining atai, Florian was starting and building user-centric technology companies as a serial entrepreneur.
Florian suffered from anxiety in his youth and was able to achieve remission through a combination of psychotherapy and robust meditation practice. It was ultimately his experiences seeing his friends and loved ones failed by the mental healthcare system that inspired him to join the movement to transform the treatment landscape for patients who have been unable to find relief in currently available therapies.
In 2022, Florian was recognized in Fortune’s 40 Under 40 list spotlighting influential individuals shaping business and Business Insider’s 30 Under 40 in Healthcare. Florian was also featured in Endpoint News’ list of 20 Under 40 Innovators in Biotech in 2021. He is a proud member of the Founders Pledge, a global community of mission-aligned entrepreneurs dedicated to doing good.
“We know that mental healthcare is likely the single largest unmet medical need in the world. We know that what’s out there now isn’t working. And we know that there are better options. So, let’s bridge the gap together.”
SRINIVAS RAO M.D., PH.D.
Srinivas Rao is the Chief Scientific Officer at atai Life Sciences. Dr. Rao has over 19 years of professional experience in the pharmaceutical and biotechnology industries. Prior to atai, Dr. Rao has held the titles of Chief Scientific, Medical, or Executive Officer at companies ranging from venture-backed startups to vertically-integrated, publicly-traded pharmaceutical companies.
Dr. Rao completed an internship in Internal Medicine at Yale-New Haven Hospital. He received his Ph.D. in neurobiology from Yale Graduate School and his M.D. from Yale School of Medicine. He holds both a Bachelor of Science and Master of Science degree in Electrical Engineering from Yale College and Yale Graduate School, respectively.
ROLANDO GUTIÉRREZ-ESTEINOU, M.D.
Rolando Gutiérrez-Esteinou is the Chief Medical Officer at atai Life Sciences since 1 January 2021. Dr. Gutiérrez-Esteinou has over 25 years of professional experience in the pharmaceutical and biotechnology industries. Prior to atai, Dr. Gutiérrez-Esteinou has held various titles of Chief Medical Officer, SVP or VP in Clinical Development, Project Management, Medical Affairs, and Pharmacovigilance at Novartis, J&J and BMS, and small biotech companies, as well as serving as therapeutic area head in Neuroscience at Covance, a large clinical research organization.
Dr. Gutiérrez-Esteinou is a graduate of the National Autonomous University of Mexico School of Medicine, in Mexico City, and completed a medicine internship and a residency in Adult Psychiatry at Harvard Medical School. He was the recipient of a Fogerty International Fellowship at the National Institute of Mental Health in the Experimental Therapeutics Branch.
STEPHEN BARDIN
Stephen Bardin joined atai Life Sciences in 2022.
Previously, Stephen was Senior Vice President, Finance and Operations at BridgeBio Pharma, Inc. where he was responsible for a broad range of finance topics, including financing strategy and execution, M&A transactions, FP&A, financial operations, and IT.
Prior to that, he worked in finance and corporate development at Myovant Sciences where he was responsible for the evaluation of business development opportunities, financing transactions, investor relations, financial operations, and special projects.
Stephen holds a Bachelor’s degree in Biomedical Engineering from Duke University and an MBA from the Stanford Graduate School of Business.
SAHIL KIRPEKAR, M.D.
Dr. Kirpekar joined atai in 2022 after more than eight years at Otsuka Pharmaceutical Co., Ltd., most recently as the Head of Business Development and Co-chair of the Global Business Development Committee.
During his tenure, Dr. Kirpekar helped build a successful pipeline of assets in CNS and beyond and was responsible for closing transactions with a total value of more than USD 2.7 billion. Notable accomplishments during his time at Otsuka also include the successful commercial launch of two drugs, Abilify Maintena (Aripiprazole) and Jinarc (Tolvaptan), and contributing to the organization’s digital strategy and leading their evolving thinking in precision psychiatry. He also collaborated closely with atai on certain strategic investments during this time.
Prior to Otsuka, Dr. Kirpekar built and executed commercial and market access strategies for biopharmaceutical companies globally as a strategy consultant at Double Helix Consulting (McCann Consulting). He also served as a market analyst for the World Health Organization and has co-founded a company building a drug delivery device focused on adherence. Dr. Kirpekar is a trained physician and holds an MPhil from the University of Cambridge (where he is subsequently an honorary lecturer).
ANNE JOHNSON
Anne Johnson joined atai Life Sciences in 2021 as Vice President, Global Controller.
Previously, Anne was a Controller at Aruvant, an International Biotechnology Company, focusing on gene therapies for rare diseases. Prior to this, she has held a number of senior leadership roles within the CFO office, include Corporate Controller at Chimerix, Inc and VP Finance at Xanodyne Pharmaceuticals.
She holds a B.Sc in Accounting from the University of North Carolina at Wilmington and is an AICPA qualified accountant.
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MILCICLIB (TZLS-201)
