OUR NEW PROFILE IS:   (NASDAQ: BRSH)

BRUUSH ORAL CARE INC. AND ARRIVE TECHNOLOGY INC. ANNOUNCE AGREEMENT AND PLAN OF MERGER

ARRIVE ACQUIRES AIRBOX TECHNOLOGIES IN ADVANCE OF BRÜUSH MERGER

BRUUSH IS ENDORSED BY FAMOUS COMEDIAN KEVIN HART

THEY  HAVE RECEIVED OVER 3,000 ORGANIC REVIEWS WITH A 90% 5-STAR RATING

THEIR RETURN RATE IS LESS THAN 1%, COMPARED TO A U.S. NATIONAL AVERAGE RETURN RATE OF 21% FOR ONLINE PURCHASES

THEIR ANNUAL CHURN RATE ON ACTIVE SUBSCRIPTIONS IS ONLY 12%, WHEREAS DOLLAR SHAVE CLUB AND HARRY’S BOTH HAVE AN ANNUAL CHURN RATE OF ALMOST 70%

VIEW THE INVESTOR PRESENTATION HERE

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Hello Everyone,

We have a new Nasdaq profile for tomorrow’s session that is hovering around .10 with planned merger upcoming.

Pull up BRSH immediately

BRSH has developed its sonic-powered Bruush electric toothbrush to make upgrading to an electric brush appealing.

Did you know that when you brush manually, you average only 200 brush strokes a minute while our Brüush provides up to 42,000 sonic vibrations per minute? That’s over 200x more than your manual!

This is a game-changing electric toothbrush that is attracting many subscribers already.

Through their website, consumers can purchase a Brüush starter kit, which includes: (i) the Brüush electric toothbrush; (ii) three brush heads; (iii) a magnetic charger; and (iv) a travel case. They developed the product to make upgrading to an electric brush appealing with three core priorities in mind: (i) a high-quality electric toothbrush at a more affordable price than a comparable electric toothbrush from the competition; (ii) a sleek, countertop-friendly design; and (iii) a convenient brush head refill subscription program that eliminates the frustrating experience of purchasing replacement brush heads at the grocery/drug store. Brüush is rooted in building a brand that creates relevant experiences and content, with the goal of becoming the go-to oral care brand for millennials and Generation Z.

There are now over 38,000 active subscriptions in its brush head refill program and the Company’s internal research demonstrated that over 85% of subscribers are interested in adding Consumables to their existing subscriptions.

Electric toothbrushes are superior to manual, but the majority of people have not switched

• Studies have shown that electric toothbrushes are more effective than manual toothbrushes1
• Despite clear oral care benefits, most people still use a traditional manual toothbrush2
• The low adoption rate shows that consumers do not find the current electric toothbrush value proposition compelling

• They  have received over 3,000 organic reviews with a 90% 5-star rating
• Their return rate is less than 1%, compared to a U.S. national average return rate of 21% for online purchases
• Their annual churn rate on active subscriptions is only 12%, whereas Dollar Shave Club and Harry’s both have an annual churn rate of almost 70%

BRUUSH ORAL CARE INC. AND ARRIVE TECHNOLOGY INC. ANNOUNCE AGREEMENT AND PLAN OF MERGER

VANCOUVER, BC and INDIANAPOLIS, IN / ACCESSWIRE / December 15, 2023 / Bruush Oral Care Inc.(Nasdaq:BRSH) (“Brüush”) and Arrive Technology Inc. (“Arrive”), a technology company focused on facilitating the last inch of the last-mile for autonomous delivery, today announced they have entered into an agreement and plan of merger. The combined company (“Combined Company”) will focus on the advancement and implementation of Arrive’s smart Mailbox-as-a-Service (MaaS) platform that makes the exchange of goods between people, robots and drones frictionless through the use of artificial intelligence (“AI”). The Combined Company is expected to operate under the name Arrive Technology Inc. with its shares listed on the Nasdaq Capital Market under the ticker symbol ‘ARRV’.  

“We are thrilled to announce this proposed merger with Arrive,” remarked Aneil Manhas, Chief Executive Officer of Brüush. “In a world hungry for a future of automated last-mile delivery, there is a critical need for a smart and secure exchange point, which Arrive is poised to redefine with its smart mailbox technology. Arrive’s strong management team, robust IP portfolio and unique Mailbox-as-a-Service platform that integrates artificial intelligence (AI) and machine-learning capabilities, positions the company well to sit at the center of the autonomous delivery network in the evolving landscape of automated exchanges. We reviewed and evaluated numerous strategic alternatives for creating stockholder value and believe this transaction with Arrive presented the most compelling option for our shareholders.”

Arrive’s Chief Executive Officer Dan O’Toole said: “We are excited about becoming Indiana’s 42nd publicly listed company and are confident our AI-powered MaaS platform will deliver excellent value to existing shareholders of both Arrive and Brüush, as well as new shareholders. This agreement and plan of merger will accelerate the development and deployment of our third-generation smart mailbox and continue to support the autonomous delivery revolution.”

About the Transaction, Management and Organization

Under the terms of the merger agreement, Brüush and Arrive will conduct a business combination in the form of a reverse triangular merger (“Merger”) via an all-stock transaction. Brüush (“PubCo”) through its wholly owned subsidiary (“Merger Sub”) will merge with and into Arrive (“Target Company“) with Target Company continuing under the name of Arrive Technology Inc. and as a wholly owned subsidiary of PubCo.

Upon completion of the Merger, the outstanding shares of Target Company’s common stock, will be exchanged for common shares of PubCo representing upon issuance, 94.5% of PubCo’s issued and outstanding common shares on a fully diluted basis. The legacy shareholders of PubCo will own shares of PubCo common shares representing 5.5% of PubCo’s issued and outstanding common shares on a fully diluted basis. The merger has been approved by the board of directors of both companies and is expected to close in the first quarter of 2024, subject to customary closing conditions.

Prior to closing, PubCo will, among other things, effect a reverse stock split with respect to PubCo’scommon shares at a ratio within the range of 6-for-1 to 200-for-1. Additionally, PubCo, will maintain a net cash minimum of US$10,000,000 consisting of cash and cash equivalents after full payment of current liabilities, including any financing and expenses in connection with the Merger. After the closing of the Merger, PubCo will sell, transfer and assign all existing legacy business, assets and liabilities of PubCo to a purchaser and pursuant to that certain separation and distribution agreement to be entered into by and between PubCo and such purchaser on terms and conditions to be mutually agreed by PubCo and such purchaser.

Additional information and details about the transaction will be provided in a Form 6-K which will be filed by Brüush with the Securities and Exchange Commission (“SEC”) and will be available at www.sec.gov.

The Combined Company will focus on advancing Arrive’s existing operations as a technology company with a focus on designing and implementing a Mailbox-as-a-Service platform that facilitates smart, secure and seamless exchange of packages between people, robots and drones. Arrive’s patented smart mailbox system leverages climate-assisted cargo space, smart alerts and advanced chain of custody controls to secure the last inch of the last-mile for all shippers, delivery services and autonomous delivery networks. Arrive’s solutions are critically and uniquely positioned in the supply chain to leverage its unique data assets for artificial intelligence to provide users with machine-learning based insights that can aid businesses and consumers to lower logistical costs and capture new growth opportunities, among other benefits.

Following the consummation of the Merger, the Combined Company will be headquartered in Indianapolis, Indiana and it is anticipated that the Combined Company will be led by current members of the Arrive management team, including:

	●	Dan O’Toole, Chief Executive Officer
	●	Todd Pepmeier, Chief Financial Officer
	●	Mark Hamm, Chief Operations Officer
	●	Torrey Bievenour, Chief Technology Officer
	●	Neerav Shah, Chief Strategy Officer
	●	Lora O’Toole, Vice President Business Development
	●	John Ritchison, Corporate Counsel

The Board of Directors of the Combined Company is expected to consist of five members, one of which will be designated by Brüush and the remainder will be designated by Arrive.

ARRIVE ACQUIRES AIRBOX TECHNOLOGIES IN ADVANCE OF BRÜUSH MERGER

ACQUISITION BROADENS PATENT PORTFOLIO AND PROPELS ARRIVE’S SMART MAILBOX AS A SERVICE CAPABILITIES

VANCOUVER, BC and INDIANAPOLIS, IN / ACCESSWIRE / December 18, 2023 / Bruush Oral Care Inc. (Nasdaq:BRSH) (“Brüush”) announced today that its pending merger partner, Arrive Technology Inc. (“Arrive”), a technology company focused on facilitating the last inch of the last-mile for autonomous delivery, has acquired AirBox Technologies (“AirBox”). This acquisition includes AirBox’s patent portfolio, which Arrive believes will broaden the capabilities of its high-tech mailbox system designed for autonomous and conventional package delivery. In addition to acquiring the patent portfolio, AirBox’s CEO Brandon Pargoe has joined the Arrive team as Vice President of Product Operations.

Mr. Pargoe, who has a background as a medical grade manufacturer and telecom network engineer, founded AirBox in 2015 with the goal of delivering medications to remote locations. Based in Falls Church, Virginia, AirBox offers two smart solution products: Airbox Home and Airbox Deep. Both products offer an app-controlled, industrial grade, web-connected package delivery solution. Additionally, Airbox has secured patents pertaining to winch capabilities, a key component for autonomous delivery drones. Airbox was the first to fly drones beyond a visual line of sight with partners in Antigua, in collaboration with the government of Antigua, the United Nations Office for Project Services and ACT Antigua.

“We are excited to welcome AirBox and Brandon to our team. We believe his extensive background in technology, medical grade manufacturing and marketing will be accretive to our business,” stated Arrive CEO Dan O’Toole. “AirBox holds patents that extend beyond their smart mailbox, covering the entire drone delivery process. We regard this acquisition as a valuable addition to our patent portfolio, a pivotal asset for our organization.”

Mr. O’Toole added that just like Arrive, AirBox was meticulously developed from the ground up and its innovative intellectual property reinforces Arrive’s standing at the forefront of smart mailbox technology.

Terms of the Arrive acquisition of AirBox were not disclosed.

Merger Between Brüush and Arrive

On December 14, 2023, Brüush and Arrive entered into an agreement and plan of merger (the “Merger”). The business combination, conducted in the form of a reverse triangular merger via an all-stock transaction, includes the registration of the securities issued by the continuing combined company (“Combined Company”) upon the Merger closing. The Combined Company will focus on the advancement and implementation of Arrive’s smart Mailbox-as-a-Service (MaaS) platform that makes the exchange of goods between people, robots and drones frictionless through the use of artificial intelligence (“AI”). The Combined Company is expected to operate under the name Arrive Technology Inc., with its shares listed on the Nasdaq Capital Market under the ticker symbol ‘ARRV’. The Merger is expected to close in the first quarter of 2024, subject to customary closing conditions.

Additional details and support documents about the Merger have been provided in a Form 6-K filed by Brüush with the Securities and Exchange Commission (“SEC”) publicly available at www.sec.gov.

About Arrive Technology Inc.

Headquartered in Indianapolis, Indiana, Arrive (formerly Dronedek) is a technology company focused on facilitating the last inch of the last-mile for autonomous delivery. Founded by serial entrepreneur Dan O’Toole, Arrive’s smart Mailbox-as-a-Service (MaaS) platform makes the exchange of goods between people, robots and drones frictionless through the use of artificial intelligence (“AI”). Arrive’s patented smart mailbox system leverages climate-assisted cargo space, smart alerts and advanced chain of custody controls to secure the last inch of the last-mile for all shippers, delivery services and autonomous delivery networks. Arrive’s solutions are critically and uniquely positioned in the supply chain to leverage its unique data assets for artificial intelligence to provide users with machine-learning based insights that can aid businesses and consumers to lower logistical costs and capture new growth opportunities, among other benefits.

Over the last ten years, subscription companies have become all the rage. These are the companies that send you packages regularly consisting of items you have picked out or they have picked out for you.

BRSH CEO Aneil Manhas believes that the company has done an excellent job of creating a premium product for an affordable price. When you get your Brüush toothbrush, you can immediately tell it is a premium product.

Toothbrush heads should be replaced every 12 weeks — which makes BRSH’s subscription model that sends customers three new brush heads every six months (for about $22) a convenient way to stay on top of changing them.

They’ve grown considerably in popularity due to their convenience. Products range from foods and beverages to household goods, clothing, beauty, books, and more. There’s a subscription for almost everything.

Subscription businesses grew revenues about 5 times faster than S&P 500 company revenues (18.2% versus 3.6%), and U.S. retail sales (14.9% versus 2.3%) from 2012 to 2020.

$600 billion by 2026! How is BRSH aiming to take a piece of this market?

The rapidly growing, direct-to-consumer leader offers subscription-based, aesthetically pleasing electric toothbrushes and oral care products.

The company has a goal to become the go-to oral care brand for millennials and Generation Z, two substantial markets.

How big are these two markets?

Nearly half of Gen Z’ers (46%) and millennials (49%), for instance, were interested in subscriptions on average, compared with about a third (34%) of the general public. 4.7

As you can see with this striking revenue growth disparity, the transformative impact of the subscription model on modern business practice is huge. Looking ahead, the subscription economy is forecast to be worth.

Endorsed by Kevin Hart….

The Bruush toothbrush is a favorite of comedian and actor Kevin Hart who signed up to be company ambassador!

“Together, we are going to take Brüush to the next level of growth and break some of the norms of the category while we are at it.”

– Kevin Hart

NEWS

PUBLISHED

DEC 18, 2023

ARRIVE ACQUIRES AIRBOX TECHNOLOGIES IN ADVANCE OF BRÜUSH MERGER

PUBLISHED

DEC 15, 2023

BRUUSH ORAL CARE INC. AND ARRIVE TECHNOLOGY INC. ANNOUNCE AGREEMENT AND PLAN OF MERGER

PUBLISHED

NOV 17, 2023

BRÜUSH RECEIVES NASDAQ NOTIFICATION REGARDING MINIMUM BID REQUIREMENTS

PUBLISHED

OCT 5, 2023

BRÜUSH ANNOUNCES NOTICE FROM NASDAQ FOR CONTINUED LISTING

PUBLISHED

OCT 2, 2023

BRÜUSH ANNOUNCES PRICING OF $5.0 MILLION PRIVATE PLACEMENT

PUBLISHED

JUL 31, 2023

BRÜUSH ORAL CARE INC. ANNOUNCES 1-FOR-25 REVERSE STOCK SPLIT EFFECTIVE PRE-MARKET OPENING ON AUGUST 1, 2023

PUBLISHED

JUL 26, 2023

BRÜUSH ORAL CARE INC. ANNOUNCES RECEIPT OF NOTICE FROM NASDAQ REGARDING THE DETERMINATION OF DELISTING

PUBLISHED

MAY 31, 2023

BRÜUSH TO PRESENT AT THE GRAVITAS 4TH LOS ANGELES SUMMIT

PUBLISHED

APR 18, 2023

BRÜUSH TO PRESENT AT THE SEQUIRE INVESTOR SUMMIT IN PUERTO RICO

PUBLISHED

APR 4, 2023

BRÜUSH APPOINTS NEW CHIEF FINANCIAL OFFICER

PUBLISHED

MAR 22, 2023

BRÜUSH TO CONTINUE TO DISRUPT AT-HOME ORAL CARE WITH UPCOMING NEW PRODUCTS

PUBLISHED

MAR 2, 2023

PARVIS INVEST INC. AND GRAVITAS II CAPITAL CORP. RECEIVE CONDITIONAL APPROVAL OF REVERSE TAKEOVER TRANSACTION AND FILE FILING STATEMENT

PUBLISHED

FEB 28, 2023

BRÜUSH TO PRESENT AT THE GRAVITAS 6TH ANNUAL GROWTH CONFERENCE

MANAGEMENT TEAM

Aneil Manhas, Chief Executive Officer

Aneil Manhas, the founder of the Company, has served as Chief Executive Officer since inception. Mr. Manhas has a career spanning over 15 years working in the financial services industry and in CEO positions of his previous companies

Recently, he was CEO of Surface 604, an electric bike company that he founded in 2015 and grew to be one of North America’s leading e-bike brands. He was also President and CEO of GVA Brands / Rosso Sports, a company he purchased in 2014 and transformed into Canada’s leader in entry-level powersports.

Mr. Manhas previously worked at Credit Suisse in Los Angeles, California for two years as an Investment Banking Analyst before joining Onex Corporation in Toronto, Ontario as a member of the investment team for five years, evaluating and executing large private equity transactions across multiple industries.

Aneil holds an Honours Business Administration (HBA) from the Richard Ivey School of Business at the University of Western Ontario.

Mandeek Manhas, Chief Financial Officer

Mandeek Manhas joined the Company in April 2023 as Chief Financial Officer to direct and oversee the Company’s finance department. Mr. Manhas has over 17 years of experience in a variety of leadership, managerial, financial, accounting, regulatory compliance, assurance, tax and advisory areas. This includes leading initiatives over operational and financial strategy, assessment of growth opportunities, governance and risk management.

Mr. Manhas joins the Company from Shape Properties, a real estate management, development and investment company with over $2.5 billion in asset value under management. As Director of Finance and Accounting for the income producing properties group, he led the finance and accounting functions through budgeting and forecasting, cash management, financial reporting, tax compliance, commercial support and overall growth of the portfolio of assets under management.

Previously, Mr. Manhas was Corporate Controller at Jervois Global (ASX: JRV, TSX-V: JRV), a dual-listed, multinational mining company with advanced development stage and exploration projects, where he led the finance department through a three-way merger with Ecobalt Solutions Inc. (TSX: ECS) and M2 Cobalt Corp. (TSX-V: MC). Prior to this, Mr. Manhas spent eleven years providing audit and advisory services with major accounting firms including Deloitte, Grant Thornton and Crowe MacKay, primarily working with small to mid-market cap corporations listed on Canadian and US exchanges.

Mr. Manhas is a Chartered Professional Accountant and holds a Bachelor of Commerce Degree from the University of British Columbia, with a double major in Finance and Accounting.

Alan MacNevin, Chief Operating Officer

Alan MacNevin joined the Company in June 2022 as Chief Operating Officer and leads the Company across all aspects of operations, driving strategic growth by directing and overseeing the scale of digital commerce, execution of strategic partnerships, launch of new products and expansion into new geographical markets. Mr. MacNevin has over 20 years of experience in executive-level positions managing large teams globally, while leading the growth at start-up e-commerce and subscription-based businesses and building them into category leaders.

Mr. MacNevin joins the Company from Rakuten Kobo, where over the past ten years he has held various executive positions including Chief Revenue Officer (2014-2015), Chief Marketing Officer (2015-2019), and most recently, Chief Operating Officer (2019-2022), where he managed the day-to-day global operations of the company. Driving growth, profitability and international expansion, Mr. MacNevin played a key role in Kobo’s emergence as a dominant player in the eReading industry.

Prior to joining Rakuten Kobo, Mr. MacNevin was a member of the executive team at Sirius Satellite Radio for six years from 2005 to 2011.  At Sirius, Mr. MacNevin led the subscriber management team as the company grew from inception to over two million subscribers before it merged with XM Canada in 2011.  Mr. MacNevin has also held senior marketing and operational roles at the Canadian Broadcasting Company, Chapters-Indigo Online and Bell Mobility.

SINCERELY,

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OUR NEW PROFILE IS:   (NASDAQ: GNPX)

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IN JUNE, THE FDA GRANTED FAST TRACK DESIGNATION FOR THE ACCLAIM-3 TREATMENT COMBINATION OF REQORSA AND TECENTRIQ AS MAINTENANCE THERAPY IN PATIENTS WITH ES-SCLC WHO DID NOT DEVELOP TUMOR PROGRESSION AFTER RECEIVING TECENTRIQ AND CHEMOTHERAPY AS INITIAL STANDARD TREATMENT

IN AUGUST, THE FDA GRANTED ORPHAN DRUG DESIGNATION TO REQORSA FOR THE TREATMENT OF SCLC

GENPREX COMPLETES A 1-FOR-40 REVERSE STOCK SPLIT EFFECTIVE FEBRUARY 2, 2024

BREAKING NEWS ANNOUNCED TODAY:  GENPREX ANNOUNCES FIRST PATIENT DOSED IN PHASE 2A EXPANSION OF ACCLAIM-1 CLINICAL STUDY OF REQORSA® THERAPY IN COMBINATION WITH TAGRISSO® TO TREAT NON-SMALL CELL LUNG CANCER

CHECK OUT THE INVESTOR PRESENTATION HERE

Genprex Announces First Patient Dosed in Phase 2a Expansion of Acclaim-1 Clinical Study of Reqorsa® Therapy in Combination with Tagrisso® to Treat Non-Small Cell Lung Cancerhttps://t.co/BXSw6ZbKeB

— Genprex, Inc. (@genprex) February 5, 2024

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Hello Everyone,

Thank you for taking the time to open up this email.  We feel like we have something that warrants your immediate attention.

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

Pull up GNPX right away.

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

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

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

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

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

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

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

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

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

There are several reasons why you should research this one right now but first and foremost is the reverse split that took place just last week.  On the 2nd of February the company executed a 1 for 40 reverse split, drastically reducing the float.  We generally see these Nasdaq’s lose some significant value following a reverse split.  After 4 straight sessions to the downside we have witnessed this one level off today after some drastic swings.  It appears to have found a floor and some support for the time being.    

The company dropped some extremely encouraging news this morning which drove it all the way to 7.99 at the open:

GENPREX ANNOUNCES FIRST PATIENT DOSED IN PHASE 2A EXPANSION OF ACCLAIM-1 CLINICAL STUDY OF REQORSA® THERAPY IN COMBINATION WITH TAGRISSO® TO TREAT NON-SMALL CELL LUNG CANCER

Expects to Complete Enrollment of Phase 2a Expansion Study by the end of 2024

Acclaim-1 Study Has FDA Fast Track Designation

AUSTIN, Texas — (Feb. 5, 2024) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that in January 2024, the first patient was enrolled and dosed in the Phase 2a expansion portion of the Company’s Acclaim-1 clinical study of Reqorsa® Therapy (quaratusugene ozeplasmid) in combination with AstraZeneca’s Tagrisso® to treat patients with late-stage non-small cell lung cancer (NSCLC).

“We are encouraged by the very promising Phase 1 results in the Acclaim-1 trial, which demonstrated the combination of REQORSA and Tagrisso was well tolerated at all three dose levels with evidence of efficacy observed in patients with non-small cell lung cancer (NSCLC) whose disease has progressed on Tagrisso,” stated Mark Berger, Chief Medical Officer of Genprex. “We are excited to begin the Phase 2a expansion portion of Acclaim-1, which will examine the toxicity profiles of different cohorts as well as efficacy and other clinical endpoints.”

Data from the Phase 1 dose escalation portion of the Acclaim-1 study were presented at the 2023 AACR-NCI-EORTC International Conference for Molecular Targets and Cancer Therapeutics Meeting in October 2023. The data reported results from twelve patients with advanced, epidermal growth factor receptor (EGFR) mutant NSCLC whose disease progressed after Tagrisso treatment. REQORSA was generally well tolerated, as there were no dose limiting toxicities.

While the Phase 1 portion of the clinical trial was designed primarily to assess safety, promising efficacy results were also observed. One patient at the 0.06 mg/kg dose level, previously treated with carboplatin, pemetrexed, and Tagrisso, had a partial remission (PR) by investigator evaluation and treatment is now ongoing in the trial after 28 cycles, which is approximately 19.5 months. Another patient who is at the 0.09 mg/kg dose level, previously treated with Tagrisso, had stable disease and treatment was ongoing after 14 cycles, or approximately 10 months. And a third patient previously treated with cisplatin, pemetrexed, carboplatin, and Tagrisso at the 0.12 mg/kg dose level has stable disease and is continuing to receive REQORSA after 14 cycles, or approximately 10 months. The extended progression free survival (PFS) of each of these patients is consistent with long-term PFS seen in several patients in prior early stage clinical trials of REQORSA, and is not expected with treatment with Tagrisso alone after progression on Tagrisso¹. PFS is the primary endpoint of both the Phase 2a expansion portion and the Phase 2b randomized portion of the Acclaim-1 study.

“Advancing Acclaim-1 marks an important milestone for Genprex. We are proud of the progress we have made thus far and are encouraged by REQORSA’s potential to improve outcomes for patients battling NSCLC. We look forward to an interim analysis from the Phase 2a study in 2025 and expect those results will further validate our novel gene therapy approach to treating lung cancer patients,” said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex.

REQORSA, the Company’s lead product candidate, is being evaluated in three clinical trials as a treatment for NSCLC and small cell lung cancer (SCLC). Each of the three lung cancer clinical programs has received a Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of that patient population, and the SCLC program has also received an FDA Orphan Drug Designation.

About Acclaim-1 Clinical Trial 

The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA, in combination with Tagrisso in patients with late-stage NSCLC with activating epidermal growth factor receptor (“EGFR”) mutations whose disease progressed after treatment with Tagrisso.

The Phase 1 dose escalation portion of the Acclaim-1 trial has been completed.  The Phase 2a expansion portion of the study is expected to enroll approximately 66 patients, half of whom will have received only Tagrisso treatment and the other half will have received Tagrisso treatment and chemotherapy, to determine toxicity profiles of patients with different eligibility criteria, as well as efficacy and other endpoints. There will be an interim analysis following the treatment of 19 patients in each cohort. The Phase 2b randomized portion of the study is expected to enroll approximately 74 patients to be randomized 1:1 to receive either REQORSA and Tagrisso combination therapy or platinum-based chemotherapy. The primary endpoint of the Phase 2b portion of the trial is progression-free survival, which is defined as time from randomization to progression or death. An interim analysis will be performed at 28 events.

About Reqorsa® Therapy
REQORSA® (quaratusugene ozeplasmid) for NSCLC and SCLC consists of the TUSC2 gene expressing plasmid encapsulated in non-viral nanoparticles made from lipid molecules (Genprex’s ONCOPREX® Nanoparticle Delivery System) with a positive electrical charge. REQORSA is injected intravenously and specifically targets cancer cells, which generally have a negative electrical charge. REQORSA is designed to deliver the functioning TUSC2 gene to cancer cells while minimizing their uptake by normal tissue. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells.

Genprex’s strategy is to develop REQORSA in combination with currently approved therapies and believes that REQORSA’s unique attributes position it to provide treatments that improve on these current therapies for patients with NSCLC, SCLC, and possibly other cancers.

Tagrisso® is a registered trademark of AstraZeneca plc.Acclaim-1 Phase 2a and Acclaim-3 Phase 1 clinical studies opening for enrollment in January 2024

Poised for FDA guidance regarding diabetes gene therapy program in 2024

AUSTIN, Texas — (January 5, 2024) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today provides a review of its 2023 achievements and a preview of plans for advancing its diabetes and oncology gene therapy programs in 2024.

“We are very proud of what we accomplished in 2023, particularly with the successful completion of the Phase 1 portion of our Acclaim-1 clinical trial in lung cancer,” said Rodney Varner, Chairman, President and Chief Executive Officer at Genprex. “In 2023, we also received a third Fast Track Designation for Reqorsa® Immunogene Therapy from the U.S. Food and Drug Administration, this time in combination with Tecentriq® for the treatment of small cell lung cancer, and REQORSA was also granted Orphan Drug Designation for the treatment of small cell lung cancer. We believe these designations underscore and further validate the potential of REQORSA. Our accomplishments in 2023, which also include process improvements in our manufacturing operations and securing new supplies of REQORSA, sets the foundation for a strong 2024.”

Oncology Gene Therapy Platform 

Genprex’s oncology program utilizes its systemic, non-viral Oncoprex® Nanoparticle Delivery System which encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company’s lead product candidate, REQORSA (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for non-small cell lung cancer (“NSCLC”) and small cell lung cancer (“SCLC”), andeach of the three lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population.

REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis (programmed cell death) in cancer cells, and modulates the immune response against cancer cells. In early studies, REQORSA has been shown to be complementary with targeted drugs and immunotherapies. Genprex’s strategy is to develop REQORSA in combination with currently approved therapies and believes that REQORSA’s unique attributes position it to provide treatments that improve on these current therapies for patients with NSCLC, SCLC, and possibly other cancers.

Important events of the year included:

• In April, at the 2023 Annual Meeting of the American Association for Cancer Research (AACR 2023), Genprex collaborators presented preclinincal gene therapy data with NPRL2, another tumor suppressor gene, that further validates the ONCOPREX Nanoparticle Delivery System as a platform

• In October, Genprex hosted a Key Opinion Leader virtual event, “Bringing Gene Therapy to the Fight Against Lung Cancers” which discussed the use of gene therapies, including REQORSA, in the fight against lung cancer

• In December, Genprex completed the successful production of a new batch of REQORSA thereby securing REQORSA supply for its Acclaim clinical studies

• Collaborators submitted abstracts in 2023 and are expecting to present data at the American Association for Cancer Research (AACR) Meeting in April 2024

Acclaim-1:

The Acclaim-1 study is a Phase 1/2 clinical trial that has three portions – a Phase 1 dose escalation which has been completed, a Phase 2a expansion, and a Phase 2b randomized portion. Acclaim-1 uses a combination of REQORSA and AstraZeneca’s Tagrisso® in patients with late-stage NSCLC that has activating epidermal growth factor receptor mutations and progression after treatment with Tagrisso. This novel approach to targeting lung cancer has demonstrated a strong safety profile with early signs of efficacy.

• In May, Genprex completed the Phase 1 portion of the Acclaim-1 clinical trial and reported encouraging results. The Acclaim-1 Phase 1 study had no Dose Limiting Toxicities and results established a Phase 2 Recommended Dose, as well as provided data showing efficacy of REQORSA in combination with Tagrisso®

• In May, after completion of the Phase 1 portion of the Acclaim-1 trial, the Safety Review Committee (“SRC”) approved advancement from the Phase 1 dose escalation portion of the trial to the Phase 2a expansion portion of the trial

• In October, clinical collaborators presented a poster presentation at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics showing the Phase 1 results of the Acclaim-1 study

• In January 2024, Genprex expects to open the Phase 2a expansion portion of the Acclaim-1 study for enrollment

• Genprex expects to complete the enrollment of 19 patients in each cohort of the Phase 2a expansion portion of the study by the end of 2024

Acclaim-2:

The Acclaim-2 study is a Phase 1/2 clinical trial that has three portions – a Phase 1 dose escalation portion, a Phase 2a expansion portion, and a Phase 2b randomized portion.  The Acclaim-2 trial uses a combination of REQORSA and Merck & Co.’s Keytruda® in patients with late-stage NSCLC whose disease has progressed after treatment with Keytruda. Patients are treated at the 0.06 mg/kg dose level in the first cohort of patients and, subject to the Acclaim-2 SRC approval, will be treated at successive dose levels of 0.09 mg/kg and 0.12 mg/kg.

• Expanding on the previously granted patents in the U.S., Japan, Mexico and Russia, Genprex was granted patents in Australia, Chile and China to cover the use of REQORSA in combination with immune checkpoint inhibtors, e.g., PD1 and PDL1 inhibitors. These patents are applicable to Genprex’s Acclaim-2 and Acclaim-3 clinical trials.

• In the second half of 2024, Genprex expects to complete enrollment in the Phase 1 dose escalation portion of the Acclaim-2 study

Acclaim-3:

The Acclaim-3 study has two portions – a Phase 1 dose escalation portion and a Phase 2 expansion portion. In November 2022 Genprex filed with the FDA the protocol for the Phase 1/2 Acclaim-3 clinical trial using a combination of REQORSA and Genentech, Inc.’s Tecentriq® as maintenance therapy for patients with extensive stage small cell lung cancer (“ES-SCLC”) who develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced.

• In June, the FDA granted Fast Track Designation for the Acclaim-3 treatment combination of REQORSA and Tecentriq as maintenance therapy in patients with ES-SCLC who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment

• In August, the FDA granted Orphan Drug Designation to REQORSA for the treatment of SCLC

• In January 2024, Genprex expects to open the Phase 1 portion of the Acclaim-3 study for enrollment, and expects to complete the Phase 1 portion of the study by the second half of 2024

• In the second half of 2024, Genprex expects to start the Phase 2 portion of the Acclaim-3 study

Diabetes Gene Therapy Platform

Genprex’s diabetes gene therapy approach is comprised of an infusion process that uses an adeno-associated virus (“AAV”) vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-003 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells. Genprex has exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education (“University of Pittsburgh”) multiple technologies relating to the development of a gene therapy product for each of Type 1 and Type 2 diabetes. In October 2023, Genprex entered into a one-year extension to the August 2022 sponsored research agreement with the University of Pittsburgh. The extension includes a revised research plan to encompass the Company’s most recent technologies to which Genprex acquired exclusive rights from the University of Pittsburgh in July 2023. These include a MafB promoter to drive expression of the Pdx1 and MafA transcription factors that can potentially be used for both Type 1 and Type 2 diabetes. This research is expected to be initially conducted in a Type 1 animal model.

• In February, Genprex’s research collaborators at the University of Pittsburgh presented preclinical data in a NHP model of Type 1 diabetes highlighting the therapeutic potential of GPX-002. These data, presented during an oral presentation at the 16^th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2023), showed  statistically significant decreases in insulin requirements, increased c-peptide levels and improved glucose tolerance compared to baseline.

• In April, the Company hosted a Key Opinion Leader virtual event, “Novel Gene Therapy to Treat Type 1 Diabetes,”  which discussed preclinical data reported at ATTD 2023 supporting gene therapy to treat Ttype 1 diabetes

• Finalized the components of the diabetes construct to take forward for nonclinical studies

• In December, Genprex submitted a request to meet with the FDA to obtain their guidance on the nonclinical studies needed to file an Investigational New Drug application and initiate first-in-human studies. As a result of the FDA’s response, the Company will continue with its planned additional nonclinical studies before requesting regulatory guidance in 2024 for the IND-enabling studies.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex’s oncology program utilizes its systemic, non-viral Oncoprex® Nanoparticle Delivery System which encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company’s lead product candidate, Reqorsa® Immunogene Therapy (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for NSCLC and SCLC. Each of Genprex’s three lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex’s SCLC program has received an FDA Orphan Drug Designation. Genprex’s diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-003 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells.

Research And Development Pipeline

Genprex Granted FDA Orphan Drug Designation (ODD) for REQORSA® Immunogene Therapy for the Treatment of Small Cell Lung Cancer https://t.co/zdKg4Vkebf $GNPX

— Genprex, Inc. (@genprex) August 10, 2023

CATALYSTS

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

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

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

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

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

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

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

– World class academic partners.

CLINICAL TRIALS

ONC-001

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

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

THE FIRST SYSTEMICALLY DELIVERED GENE THERAPY USED FOR CANCER IN HUMANS

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

Metabolic Tumor Response in a Metastatic Lung Cancer Subject

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

ONC-002

COMBINING REQORSA® IMMUNOGENE THERAPY WITH TARCEVA (ERLOTINIB)

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

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

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

TECHNOLOGY

REQORSA® IMMUNOGENE THERAPY

THE FIRST SYSTEMICALLY DELIVERED GENE THERAPY USED FOR CANCER IN HUMANS

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

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

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

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

OVERCOMING DRUG RESISTANCE

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

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

GPX-002

DIABETES GENE THERAPY

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

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

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

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

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

ONCOPREX® NANOPARTICLE DELIVERY SYSTEM

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

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

DESIGNED TO DELIVER CANCER-FIGHTING GENES SYSTEMICALLY

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

OPTIMIZED PARTICLE SIZE

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

ENHANCED SAFETY AND EFFICACY DESIGN

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

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

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

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

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

GENPREX (NASDAQ:GNPX) RELEASES NEW PATIENT VIDEO INTERVIEW DESCRIBING POSITIVE EXPERIENCE IN CLINICAL

AUSTIN, TX / ACCESSWIRE / June 2, 2023 / A clinical-stage gene therapy company is making splashes in the medical world. Genprex, Inc. (NASDAQ:GNPX) is developing potentially life-changing therapies for patients with cancer and diabetes that have limited treatment options. The company is working with world-class institutions in developing new drugs from the company’s pipeline of gene therapy candidates in order to provide novel treatment approaches. Its oncology program utilizes its proprietary non-viral ONCOPREX® Nanoparticle Delivery System, which Genprex believes is the first systemic gene therapy delivery platform used for cancer in humans. The company’s lead drug candidate is called REQORSA®. The immunogene therapy (also known as quaratusugene ozeplasmid) is for both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) and uses the company’s unique, proprietary ONCOPREX® Nanoparticle Delivery System. The drug may be helpful for treating patients who have already demonstrated drug resistance to other treatments.

On the heels of the release of recent positive safety and early efficacy data related to the phase 1 portion of its Acclaim-1 phase 1/2 clinical trial for non-small cell lung cancer evaluating REQORSA in combination with Tagrisso, Genprex has released a new patient video featuring an NSCLC patient from the phase 1 portion of its Acclaim-1.

All patients in the trial had disease progression on their previous cancer treatment. In the video, an NSCLC patient who experienced extended Progression Free Survival (PFS) in the trial describes her positive experience taking REQORSA – Genprex’s lead drug candidate which she is still taking – while participating in the phase 1 portion of the Acclaim-1 clinical trial.

“While on REQORSA treatment, my doctor noted that the lung cancer lesions have not grown and there is no new growth,” said the NSCLC patient in the Phase 1 portion of Acclaim-1. “I believe the REQORSA treatment has benefited my life and has increased my time.”

The patient’s positive experience is encouraging – she was able to continue working full-time while participating in the clinical trial. She experienced only minor side effects from REQORSA and so far has experienced more than 10 months of progression-free survival.

NSCLC is the most common type of lung cancer, accounting for about 82% of all cases. While there have been some advances in treatment options for NSCLC, such as chemotherapy, radiation therapy and targeted therapies, the overall survival rate for patients with advanced NSCLC remains low. The five-year survival rate for patients with distant spread is 7%.

Genprex has disclosed favorable preliminary clinical data from the Acclaim-1 clinical trial’s phase 1 dose-escalation segment in an abstract published at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The findings show that REQORSA was well tolerated with no dose-limiting toxicities. Furthermore, Genprex reported preliminary evidence of efficacy in the phase 1 portion of the study.

“We are thrilled to have our abstract, which reports positive results from the phase 1 portion of our Acclaim-1 clinical trial, published at the ASCO Annual Meeting,” said Mark Berger, MD, Chief Medical Officer at Genprex. “We are encouraged by the favorable safety profile of REQORSA, as well as the preliminary efficacy data we have observed. In fact, the Safety Review Committee has just approved our advancement into the phase 2 expansion portion of the clinical trial.”

As noted above, the company also announced that its Safety Review Committee (SRC) has approved the advancement of the Acclaim-1 clinical trial to the phase 2 expansion portion of the trial. The SRC has examined the full safety data and has approved the recommended phase 2 dose of REQORSA, which is 0.12 mg/kg, twice the highest dose level delivered in Genprex’s previous clinical trials. This approval is a significant milestone in REQORSA’s development program. The SRC’s recommendation to advance the trial to the phase 2 expansion portion is a significant milestone for REQORSA.

Genprex’s REQORSA drug seems to be a promising innovation in cancer treatment. REQORSA’s unique approach of targeting the tumor suppressor gene TUSC2 sets it apart from other cancer treatments and other genetic medicines. Similar to companies like Bluebird Bio or Editas Medicine Inc., who are developing innovative therapies for rare diseases or using different gene editing techniques for cancer, Genprex’s REQORSA has the potential to be a game-changer in the field of cancer treatment through gene therapy.

NEWS

GENPREX ANNOUNCES FIRST PATIENT DOSED IN PHASE 2A EXPANSION OF ACCLAIM-1 CLINICAL STUDY OF REQORSA® THERAPY IN COMBINATION WITH TAGRISSO® TO TREAT NON-SMALL CELL LUNG CANCER

FEBRUARY 5, 2024

Expects to Complete Enrollment of Phase 2a Expansion Study by the end of 2024

Read More

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GENPREX ANNOUNCES 1-FOR-40 REVERSE STOCK SPLIT EFFECTIVE FEBRUARY 2, 2024

JANUARY 31, 2024

Genprex today announced that on February 2, 2024, the Company will implement a 1-for-40 reverse split of its issued and outstanding common stock, par value $0.001 per share.

Read More

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GENPREX PROVIDES BUSINESS UPDATE AND OUTLOOK FOR 2024 

JANUARY 5, 2024

Acclaim-1 Phase 2a and Acclaim-3 Phase 1 clinical studies opening for enrollment in January 2024

Poised for FDA guidance regarding diabetes gene therapy program in 2024

Read More

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GENPREX TO PRESENT AT BIO-EUROPE 2023 CONFERENCE 

NOVEMBER 1, 2023

Presentation to be held on Tuesday, November 7, 2023 from 4:45 – 5:00 p.m. UTC

Read More

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GENPREX TO HOST A VIRTUAL KEY OPINION LEADER EVENT ON “BRINGING GENE THERAPY  TO THE FIGHT AGAINST LUNG CANCERS”

OCTOBER 20, 2023

Webinar to be held on Friday, October 27, 2023 from 12:30 pm – 1:45 pm Eastern Time

Read More

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GENPREX TO PRESENT DATA ON THE USE OF REQORSA® FOR THE TREATMENT OF LUNG CANCERS AT 2023 AACR-NCI-EORTC INTERNATIONAL CONFERENCE ON MOLECULAR TARGETS AND CANCER THERAPEUTICS

OCTOBER 4, 2023

Acclaim-1 Phase 1 study had no Dose Limiting Toxicity, and results establish Phase 2 Recommended Dose as well as provide data showing efficacy of REQORSA® in combination with Tagrisso®

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GENPREX TO PRESENT AT UPCOMING SEPTEMBER INVESTOR CONFERENCE

SEPTEMBER 7, 2023

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

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GENPREX APPOINTS SUZANNE THORNTON-JONES AS SENIOR VICE PRESIDENT, REGULATORY AFFAIRS

AUGUST 22, 2023

Strengthens management team with seasoned regulatory expert to support pipeline of gene therapies for the treatment of cancer and diabetes, including two clinical trials in Non-Small Cell Lung Cancer and one in Small Cell Lung Cancer

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GENPREX GRANTED FDA ORPHAN DRUG DESIGNATION (ODD) FOR REQORSA® IMMUNOGENE THERAPY FOR THE TREATMENT OF SMALL CELL LUNG CANCER

AUGUST 10, 2023

ODD is in addition to Three FDA Fast Track Designations

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GENPREX ANNOUNCES CLOSING OF $7.5 MILLION REGISTERED DIRECT OFFERING PRICED AT-THE-MARKET UNDER NASDAQ RULES

JULY 21, 2023

Genprex announced the closing of its previously announced registered direct offering to healthcare-focused institutional investors of 7,425,744 shares of the Company’s common stock and warrants to purchase up to 7,425,744 shares of common stock at a combined offering price of $1.01 per share of common stock and accompanying warrant.  The offering was priced at-the-market under the Nasdaq rules.

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BELL2BELL PODCAST FEATURING CEO RODNEY VARNER & CFO RYAN CONFER OF GENPREX, INC. (NASDAQ: GNPX)

JULY 6, 2023

Bell2Bell’s latest podcast features Chairman, President and CEO Rodney Varner and CFO Ryan Confer of Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients living with cancer and diabetes. In this interview, Varner and Confer discuss the journeys that led them to Genprex and the promise of the company’s drug development pipeline.

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GENPREX GRANTED CHINESE PATENT FOR REQORSA® IMMUNOGENE THERAPY IN COMBINATION WITH PD-1 ANTIBODIES TO TREAT CANCERS

JULY 5, 2023

Provides Additional Protection in Large Markets for Therapeutic Combination in Acclaim-2 Phase 1/2 Clinical Trial

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GENPREX RECEIVES U.S. FDA FAST TRACK DESIGNATION FOR REQORSA® IMMUNOGENE THERAPY IN COMBINATION WITH TECENTRIQ® FOR THE TREATMENT OF SMALL CELL LUNG CANCER

JUNE 28, 2023

Third FDA Fast Track Designation Further Validates the Potential of REQORSA

AUSTIN, Texas — (June 28, 2023) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the U.S.

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MANAGEMENT

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

SINCERELY,

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OUR NEW PROFILE IS:   (NYSE: SRFM)

PRO FORMA1 REVENUE, WHICH ASSUMES PRO FORMA OPERATING RESULTS FOR BOTH SURF AIR AND SOUTHERN FOR THE FULL YEAR OF 2023, IN THE RANGE OF $107.5 MILLION TO $112.5 MILLION, AS COMPARED TO $101 MILLION FOR THE FULL YEAR 2022

SURF AIR MOBILITY ENTERS AGREEMENT TO SUPPLY ELECTRIC POWERTRAINS TO KENYA’S LARGEST CESSNA CARAVAN CHARTER OPERATOR Z.BOSKOVIC AIR CHARTERS AS WELL AS OTHER MAJOR KENYAN CESSNA CARAVAN OPERATORS SAFARILINK AND YELLOW WINGS

SRFM IS ALREADY THE LARGEST COMMUTER AIRLINE IN THE US BY SCHEDULED DEPARTURES, FLYING OVER 450K PASSENGERS ON ROUGHLY 75K FLIGHTS IN 2022

READ THE INVESTOR PRESENTATION HERE

Hello Everyone,

We are back with another exciting profile that we want you to research for Wednesday’s session.

This is another company that we have never profiled on our newsletter before that is fairly new to the market.

Pull up SRFM Immediately and start your research. 

This one has seen strong YOY growth and already has significant revenues coming in the door.  Surf Air Mobility is a Los Angeles-based regional air mobility platform seeking to expand the category of regional air travel by reinventing flying through the power of electrification. In an effort to substantially reduce the cost and environmental impact of flying and as the operator of the largest commuter airline in the US by scheduled departures, Surf Air Mobility intends to develop proprietary powertrain technology with its commercial partners to electrify existing fleets and bring electrified aircraft to market at scale.

Instead of building a new electric aircraft completely from scratch, which could take decades, Surf Air Mobility is partnering with aviation manufacturing giant Textron Aviation and leading aviation tech innovator AeroTEC to developing revolutionary new technology to support in upgrading the widely popular Cessna Grand Caravan aircraft with fully electric and hybrid-electric powertrains, once certified. 

Surf Air Mobility has already made major strides in its global expansion plans, signing several significant deals with aircraft operators to upgrade the widely popular Cessna Grand Caravan aircraft with fully electric and hybrid-electric powertrains in key global markets.

Let’s take a look at some of the Major Strengths Surrounding SRFM:

Green Regional Air Travel: Surf Air Mobility (NYSE:SRFM) is aiming to be the first to commercialize green regional air travel, presenting a major leap forward in sustainable transportation. Their focus on electric airplanes could redefine short-haul flights, making air travel more affordable for more people in more places.

Large Addressable Market: The market potential for regional air mobility is significant, with an estimated global total addressable market (TAM) of $ ~75-115 billion by 2035. 

Largest Commuter Airline in the US: Surf Air Mobility is already the largest commuter airline in the US by scheduled departures, flying over 450,000 passengers on ~75,000 flights to 48 destinations in the US in 2022.

Unique Business Model: Surf Air Mobility offers a comprehensive approach with an integrated platform model that supports the expansion of both sides of the equation: passengers (B2C) and aircraft operators (B2B). 

Diversified Revenue Streams: Surf Air Mobility (NYSE:SRFM), which has reported ~$101M in revenue in 2022, operates across multiple revenue streams which include scheduled air service, recurring government contracts through the Essential Air Service (EAS) program, and off-fleet on-demand operations.

Strategic Partnerships: The company has strong commercial relationships with industry leaders across the value chain including Palantir Technology, Textron Aviation, Jetstream Aviation Capital.

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Approximately 21% of all US flights are now being delayed or canceled. So even after you’ve gone through the hassle of getting to the airport 2-3 hours prior to departure, your flight isn’t even guaranteed.

Since the beginning of 2024, there have been an average of 21,445 delays across the world every day, including over 4,000 traveling within, into, or out of the US.

What’s astonishing is that while there are more than 5,000 regional airports in the US, but only 30 airports handle ~70% of the country’s air travel. Surprisingly, major airlines either cannot or are unwilling to utilize these smaller airports. Thankfully, a solution is emerging in the form of regional air mobility (RAM), with the potential to provide a new kind of mass transit alternative.

At the forefront of this revolutionary new aviation trend is Surf Air Mobility Inc. (NYSE:SRFM), which owns the largest commuter airline in the US by scheduled departures.

Surf Air is replacing long drives and overcrowded commercial airports with seamless point-to-point air travel by expanding its already-established network and connecting underutilized regional airports across the US. 

But it’s not just its leadership in regional travel that could make this company such a game changer. Surf Air Mobility believes it can completely transform regional flying through the power of electrification.

By partnering with the largest general aviation manufacturer Textron Aviation and  AeroTEC, a leader in aviation technology, Surf Air Mobility (NYSE:SRFM) seeks to gain a first-mover advantage in the new age of aviation.

Instead of building a new electric aircraft completely from scratch, which could take decades, Surf Air plans to use existing aircraft that are already flying today and swap out their engines for hybrid or fully electric powertrains.

With an established customer base, a faster, practical path to electrification certification and an impressive roster of partners, Surf Air Mobility (NYSE:SRFM) believes it is uniquely positioned to be the first company to commercialize green regional air travel.

Surf Air Mobility (NYSE:SRFM) is gearing up for an exciting 2024, with a string of strategic moves.

Some recent strategic moves from Surf Air Mobility (NYSE:SRFM) include restructuring its capital structure with GEM (the amended agreement is intended to reduce near-term overhang, impose a volume restriction, and increase flexibility to redeem), increasing its global presence with operator partnerships in East Africa and Brazil, and adding more subsidized commuter routes with planned launches in the future. 

Some recent strategic moves from Surf Air Mobility (NYSE:SRFM) include restructuring its capital structure with GEM, increasing its global presence with operator partnerships in East Africa and Brazil, and bolstering its multiple revenue streams through additional lower-risk, subsidized commuter routes with planned launches in the future. 

In the ever-evolving realm of aviation, Surf Air Mobility Inc. (NYSE:SRFM) stands out with its forward-looking approach towards a new kind of mass transit solution.

A new way to travel made possible by electrification, lowering the cost of smaller planes and making them accessible in more places for more people.

Electric aircraft promise to be more cost-effective. By reducing or removing expensive, polluting jet fuel from the equation and replacing it with electric batteries, operations become leaner, greener, and more financially sound.  Similar to what’s been unfolding over the last decade with cars, this same evolution is beginning to shape the future of air travel as well.

What’s more, by connecting more places with seamless, quick flights it can take people off the roads and put them into the sky, leading to less pollution traffic, and happier travelers.

In short, cars are a slower solution and big planes are an expensive and tedious solution. Surf Air Mobility Inc. (NYSE:SRFM) is the best of all worlds. It also has the potential to be better for the planet too.

Here’s a closer look at the company’s multi-pronged strategy to transform the skies:

After the strategic acquisition of Southern Airlines, Surf Air Mobility hit the ground running with an operational fleet of 50 aircraft at its disposal.

But Surf Air doesn’t stop there. The company has also entered into an exclusive agreement with AeroTEC. This strategic alliance is designed to fast-track the development and certification process of its commercial electric aircraft technology through what’s called a Supplemental Type Certification (STC). 

And we’ve already seen examples of electrified technology take flight. Thanks to a separate project from AeroTEC, a fully-electrified Cessna Grand Caravan has already been flown on a demonstration flight. This successful demonstration was tangible proof that the technology is feasible.

Thanks to a separate project from AeroTEC, a fully-electrified Cessna Grand Caravan has already been flown on a demonstration flight. This successful demonstration was tangible proof that the technology is feasible.

What truly distinguishes Surf Air Mobility (NYSE:SRFM) from other companies in the space is the company’s strategic approach. Instead of constructing new aircraft from scratch, they’re focusing on electrifying existing aircrafts. Specifically, the Cessna Grand Caravan. By upgrading planes that have already been transporting thousands of passengers across the US, they believe they’re taking a practical, efficient route to electric aviation.

Some of the clear advantages that set Surf Air (NYSE:SRFM) apart include:

• Exclusive Partnerships: Their unique relationship with Textron Aviation, the largest general aviation manufacturer, gives them access to expertise and resources 
• in order to help bring their electric vision to life.
• Existing Infrastructure: With an established customer base and pre-existing routes, Surf Air doesn’t have to start from zero. They’re already integrated into the aviation ecosystem. Not to mention the ~5,000 underutilized regional airports that already exist in the US.
• Speed to Market: By upgrading existing aircraft with new electric and hybrid engines, Surf Air Mobility has the potential to bring its electrified aircraft to market quicker than those building from scratch.Their first-generation fully-electric powertrain technology could revolutionize the industry once certified, with targets to slash direct operating costs by up to 50% and eliminating 100% of direct carbon emissions.

Surf Air Mobility (NYSE:SRFM) has already inked strategic supply deals with air operators in East Africa and Brazil to develop electric fleets. 

On January 4, Surf Air Mobility unveiled a groundbreaking agreement with Safarilink and Yellow Wings Air Services, aimed at reshaping air travel across Kenya and Tanzania, and extensively throughout East Africa’s airfields. This electrifying partnership positions Surf Air Mobility at the vanguard of aviation innovation, as it plans to bring its revolutionary electrified powertrain technology to African operators, Safarilink and Yellow Wings. With these operator agreements to upgrade their existing Cessna Grand Caravan aircraft fleets with their cutting-edge, proprietary technology once certified, Surf Air Mobility (NYSE:SRFM) is not just expanding its global presence, but also pioneering a new era in sustainable aviation globally.

This trailblazing move follows closely on the heels of last year’s similar pact with Azul, Brazil’s largest airline, underscoring Surf Air Mobility‘s commitment to transform a fleet of up to 27 Cessna Caravans. Their first-generation fully-electric powertrain technology is set to revolutionize the industry, with targets to slash direct operating costs by up to 50% and achieving the remarkable feat of eliminating 100% of direct carbon emissions. This will mark a significant leap towards a cleaner, more efficient, and more sustainable future in air travel.

While several companies are vying for a share of the emerging electric aviation market, Surf Air Mobility (NYSE:SRFM) distinguishes itself in critical ways that offer tangible value to both consumers and investors. Unlike Joby Aviation, BETA Technologies, Archer Aviation, and Lilium N.V.—all of which are pre-revenue from a consumer service—Surf Air Mobility boasted a revenue of ~$101 million in 2022.

And unlike Blade Air Mobility, which lacks its own electrified IP, Surf Air Mobility is developing proprietary electric technology and is already offering consumer services.

Surf Air Mobility Inc. (NYSE:SRFM) also has access to $850 million in capital, giving the company runway to fuel its growth.

The company also recently restructured its capital structure with a term sheet related to the potential issuance of a mandatory convertible debenture to GEM, which aims to reduce near term overhang and dilution.

Take a look at the company’s market cap compared to its peers.

Despite Surf Air’s revenue, access to capital and cutting-edge technology, its market value is roughly $96 million. However, this could change based on the company’s revenue growth guidance for the coming years.

Company	Symbol	Share Price (USD)	Market Cap (USD)	Revenue (USD)
Surf Air Mobility	NYSE:SRFM	$1.30	$95.61M	$101M
Joby Aviation	NYSE:JOBY	$5.8	$4.4B	$0
BETA Technologies	PRIVATE	N/A	$2.4B	$0
Archer Aviation	NYSE:ACHR	$4.95	$1.489B	$0
Blade Air Mobility	NASDAQ:BLDE	$3.00	$224.52M	$146M

*Share price and market cap taken from Yahoo Finance on January 30, 2024

“Regional Air Mobility (RAM) will fundamentally change how we travel, bringing the convenience, speed, and safety of air travel to all Americans, irrespective of their distance from a major hub.” – NASA

McKinsey & Company predicted that “Innovative propulsion… could introduce a new era of frequent, convenient passenger flights on smaller regional aircraft.”

The financial horizon is even brighter. By 2035, the global market for these regional flights could be valued between $75 billion and $115 billion.

However, what truly makes Surf Air (NYSE:SRFM) the ‘Uber of Commercial Air Travel’ is its approach to streamlining and enhancing the user experience. 

The company’s tech-savvy regional charter platform reimagines how we access air travel, making aircraft more accessible to travelers. Star-Studded Partnerships in Place

In the emerging regional air mobility industry, Surf Air Mobility Inc. (NYSE:SRFM) has brought together a powerful network of industry-leading partners.

Aircraft Manufacturing: Textron Aviation

One of the cornerstones of Surf Air’s (NYSE:SRFM) strategy is its exclusive relationship with Textron Aviation, a subsidiary of Textron Inc. (NYSE:TXT), one of the world’s largest general aviation manufacturers. Textron Aviation will support Surf Air Mobility’s development of electrified Cessna Grand Caravan EX aircraft. This partnership comes with a large fleet order that ensures supply scalability, thereby providing a solid foundation for Surf Air’s regional air mobility (RAM) platform.

Software Development: Palantir Technologies

In a world that increasingly relies on big data and artificial intelligence, Surf Air (NYSE:SRFM) has teamed up with Palantir Technologies (NYSE:PLTR), a trailblazer in data-driven and AI operations. They’re working hand-in-glove to develop solutions for the burgeoning RAM industry. This partnership amplifies Surf Air’s operational efficiency and predictive capabilities, with the potential to put them leaps and bounds ahead of the competition.Certification: AeroTEC

Ensuring that their technology is certified and up to industry standards, Surf Air has entered into an exclusive agreement with AeroTEC, a Tier-1 aerospace supplier. AeroTEC will certify the electrification technology for the Cessna Caravan, and the deal ensures that Surf Air Mobility (NYSE:SRFM) owns the Supplemental Type Certificate IP.

Aircraft Financing: Jetstream Aviation Capital

Surf Air Mobility (NYSE:SRFM) has ensured a consistent inflow by partnering with Jetstream Aviation Capital, the largest global aircraft lessor for commercially-operated turboprops. Through efficient off-balance-sheet financing of up to $450 million, Surf Air has obtained flexible capital for aircraft financing.

Pilot Recruitment: SkyWest Airlines

Surf Air Mobility’s (NYSE:SRFM) pilot pipeline agreement with SkyWest Airlines, a subsidiary of SkyWest Inc. (NASDAQ:SKYW), ensures a competitive advantage in pilot recruitment, effectively tackling a major HR challenge in aviation.

DIVERSIFIED REVENUE STREAMS

In the ever-changing travel sector, Surf Air Mobility Inc. (NYSE:SRFM) has diversified its revenue streams.  

Scheduled regional flights remain the core offering of Surf Air, connecting 48 US cities across five time zones in 2022. The time-savings and convenience offered through these flights have positioned the company as a leader in the regional market. Customers can choose a single seat on a scheduled flight or a private on-demand charter.

The company’s involvement in government-contracted Essential Air Service (EAS) as another pillar in its diversified revenue model. This helps cement Surf Air’s (through its sub-brand Southern Airways) reputation as a reliable partner for crucial operations.

In December, Surf Air Mobility Inc. (NYSE:SRFM) inked an agreement with Purdue University to begin subsidized scheduled commuter air service between Purdue University Airport (LAF) and Chicago O’Hare Airport (ORD) targeted for early Q2 2024.

This service, offering up to 24 weekly flights, will make travel easier for Purdue’s community, directly connecting them to one of America’s busiest airports. Uniquely, this initiative leverages the successful EAS model, but without federal funding, demonstrating Surf Air Mobility‘s innovative approach to enhancing regional connectivity.

Just weeks later, the company announced plans to initiate commuter air service between Williamsport Regional Airport (IPT) and Washington Dulles International Airport (IAD) starting May 2024. This service aims to offer the Williamsport and Lycoming County communities easier and more affordable access to air travel, targeting ten weekly flights directly connecting them to a major hub, bypassing long drives. 

In December, Surf Air Mobility Inc. (NYSE:SRFM) inked an agreement with Purdue University to begin subsidized scheduled commuter air service between Purdue University Airport (LAF) and Chicago O’Hare Airport (ORD) targeted for Q2 2024. This service, with a target to offer up to 24 weekly flights, will make travel easier for Purdue’s community, directly connecting them to one of America’s busiest airports. Uniquely, this initiative leverages the successful EAS model, but without federal funding, demonstrating Surf Air Mobility‘s innovative approach to enhancing regional connectivity.

Just weeks later, the company announced plans to initiate commuter air service between Williamsport Regional Airport (IPT) and Washington Dulles International Airport (IAD) starting May 2024. This service aims to offer the Williamsport and Lycoming County communities easier and more affordable access to air travel, targeting ten weekly flights directly connecting them to a major hub, bypassing long drives. 

Both of these deals underscore Surf Air Mobility’s commitment to enhancing regional air travel and greatly expands the company’s total addressable market.

Surf Air Mobility (NYSE:SRFM) is also planning a Aircraft-as-a-Service (ACaaS) offering. This all-in-one package, once developed, will let air operator companies lease planes and use special software to optimize their business, creating the potential for yet another way for Surf Air to generate revenue.

NEWS 

PUBLISHED

JAN 17, 2024

US EXCEEDS $55 BILLION INVESTMENT IN AFRICA, FOCUSING ON INFRASTRUCTURE FOR SUSTAINABLE GROWTH

PUBLISHED

JAN 17, 2024

SURF AIR MOBILITY ENTERS AGREEMENT TO SUPPLY ELECTRIC POWERTRAINS TO KENYA’S LARGEST CESSNA CARAVAN CHARTER OPERATOR Z.BOSKOVIC AIR CHARTERS

PUBLISHED

JAN 8, 2024

PILOTLESS CARGO AIRCRAFT TAKES FLIGHT OVER SAN FRANCISCO BAY

PUBLISHED

JAN 8, 2024

SURF AIR MOBILITY AND WILLIAMSPORT, PENNSYLVANIA ENTER AGREEMENT FOR SUBSIDIZED COMMUTER AIR SERVICE BETWEEN WILLIAMSPORT REGIONAL AIRPORT (IPT) AND WASHINGTON DULLES INTERNATIONAL AIRPORT (IAD)

PUBLISHED

JAN 4, 2024

SURF AIR MOBILITY ENTERS AGREEMENTS TO SUPPLY ELECTRIC POWERTRAINS TO MAJOR KENYAN CESSNA CARAVAN OPERATORS SAFARILINK AND YELLOW WINGS

PUBLISHED

DEC 28, 2023

SURF AIR MOBILITY ENTERS INTO BINDING TERMS FOR A $35.2 MILLION MANDATORY CONVERTIBLE DEBENTURE WITH GEM GLOBAL YIELD LLC

PUBLISHED

DEC 27, 2023

SURF AIR MOBILITY ANNOUNCES OLIVER REEVES AS CHIEF FINANCIAL OFFICER

PUBLISHED

DEC 13, 2023

DUTCH STARTUP PLANS TO TRANSFORM AIR TRAVEL WITH 80-SEATER HYBRID-ELECTRIC PLANE

PUBLISHED

DEC 8, 2023

ECO-FRIENDLY FLYING: AIR NEW ZEALAND EMBRACES ELECTRIC PLANES FOR MAIL DELIVERY

PUBLISHED

DEC 8, 2023

SURF AIR MOBILITY AND PURDUE UNIVERSITY ENTER AGREEMENT FOR PRIVATELY SUBSIDIZED COMMUTER AIR SERVICE BETWEEN WEST LAFAYETTE / PURDUE UNIVERSITY AIRPORT (LAF) AND CHICAGO O’HARE AIRPORT (ORD)

PUBLISHED

DEC 4, 2023

HYDROGEN-ELECTRIC AIRCRAFT PROJECT RAISES $116 MILLION

PUBLISHED

NOV 27, 2023

SURF AIR MOBILITY AND AZUL CONECTA ENTER AGREEMENT TO INCORPORATE ELECTRIC POWERTRAINS INTO AZUL’S CESSNA CARAVAN FLEET

PUBLISHED

NOV 14, 2023

SURF AIR MOBILITY REPORTS REVENUE GROWTH IN THIRD QUARTER 2023 AND MAINTAINS FULL YEAR GUIDANCE

PUBLISHED

NOV 9, 2023

SURF AIR MOBILITY FILES FORM S-1 REGISTRATION STATEMENT WITH THE SEC REGISTERING UP TO 300 MILLION SHARES OF COMMON STOCK

PUBLISHED

OCT 31, 2023

SURF AIR MOBILITY TO PROVIDE THIRD QUARTER 2023 FINANCIAL RESULTS ON NOVEMBER 14, 2023

PUBLISHED

OCT 12, 2023

REGENT ANNOUNCES DEAL WITH SURF AIR TO ESTABLISH SEAGLIDER SERVICE IN MIAMI

MANAGEMENT

Stan Little – CEO

Since 2013, Little has been the founder, Chairman, and CEO of Southern Airways Express and Mokulele Airlines. A practicing attorney since 2002, he is also Senior Partner Emeritus at Little & Barton, PLLC. His extensive business and industry experience qualifies him to serve as SAM’s CEO and board member.

Fred Reid – Head of Global Business Development

A global aviation leader, Fred Reid has built products and services enjoyed by consumers around the world. As the founding CEO of Virgin America, America’s top airline for nearly 10 years, Fred helped create the “next generation airline”. Fred has also served as President of Lufthansa, Delta, Kitty Hawk, and Flexjet, and served as the Global Head of Transportation at Airbnb.

DAVID ANDERMAN

Chief Legal Officer

David Anderman is a seasoned executive with a passion for business strategy and dealmaking in the technology, digital media, aerospace, and consumer sectors. He most recently served as the General Counsel of SpaceX, Elon Musk’s rocket company, where he supported the launch of NASA astronauts to the International Space Station (the first-ever launch of humans by a private company), the maiden flight of Starship (SpaceX’s Mars colony ship), and the rollout of the Starlink global satellite internet system. Prior to SpaceX, Mr. Anderman spent 16 years at Lucasfilm Ltd., George Lucas’s entertainment empire, starting as the junior lawyer and rising through the ranks to become Chief Operating Officer and General Counsel.

Oliver Reeves – Chief Financial Officer

Oliver Reeves is a seasoned financial executive with a proven track record at both the strategic and operational levels. He will lead Surf Air Mobility’s financial and capital markets strategies, leveraging nearly two decades of experience in the investment management, enterprise technology, and insurance industries. Prior roles include serving as Chief Strategy Officer at Xinuos, Inc. since 2019.

IDO GRUBERGER

Chief Strategy Officer

Ido has over a decade of experience in aviation. He joined the Surf Air management team in 2016 and has led corporate development, strategy and air-operations. He is also an advisor to early stage startups in the LA area. Prior to Surf Air, Ido is a former military aviator and worked at the Boston Consulting Group (BCG). He holds a BA in economics from Ben Gurion University and an MBA from MIT’s Sloan School of Management.

Carl Albert – Chairman

Albert boasts extensive experience in aviation, formerly serving as principal investor and Chairman & CEO of Wings West Airlines, acquired by AMR, and later of Fairchild Aircraft for a decade. Under his leadership, Fairchild acquired German manufacturer Dornier Luftfahrt, both companies producing regional aircraft and Dornier supplying Airbus with key components for multiple models. Albert also oversaw Merlin Express, a cargo service for UPS and FedEX. He has managed engineering programs to obtain various aircraft certifications from regulatory bodies like FAA and EASA.

Sudhin Shahani – Co-Founder Shahani is a seasoned entrepreneur and venture capital investor with a diverse portfolio in aviation, media, technology, and education. He is the co-founder of Surf Air Mobility, where he has been steering the company’s vision, fundraising, and M&A activities since 2014. Under his leadership, Surf Air has raised over $400M and pioneered sustainable flight technologies. Before this, he was an Entrepreneur in Residence at Anthem Ventures, managing over $450M and serving on various boards. Shahani also co-founded Musicane and RTG Animate.

SINCERELY,

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OUR NEW PROFILE IS:   (NASDAQ: TRNR)

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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

LATE LAST YEAR 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……………….THE COMBINED BUSINESS IS EXPECTED TO BE CASH FLOW POSITIVE AND TO ACHIEVE POSITIVE ADJUSTED EBITDA BASED ON IDENTIFIED COST SYNERGIES

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

TRNR AMENDS TERMS OF CLMBR ACQUISITION AND EXPECTS TO CLOSE IN JANUARY 2024, CREATING A HIGH-GROWTH, B2B FOCUSED, CONNECTED FITNESS PLATFORM

CHECK OUT THE INVESTOR PRESENTATION HERE

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Hello Everyone,

We have another profile for you to research before the open tomorrow.

This is a company that just IPO’d last year and is sitting at significant discount from the IPO levels.

It has picked up some momentum over the past few sessions and we want to put this on your radar for a potential reversal.

They just put out encouraging news this morning.

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.

FORME’s smart home gyms have been recognized by major fitness publications in 2023, such as Men’s Health, Shape, and Good Housekeeping as the best in at-home fitness.

The company recently went into mass production of its smart home gym products and is raising capital to fund commercialization and rapid growth.

CATALYSTS

• Through years of research and development, FORME has developed the smartest business model compared to its peers that is designed to generate high annual recurring revenue.
• FORME began mass production of its smart home gyms at the end of 2022 and is already sold out.
• The company’s current product portfolio, which consists of FORME Studio, FORME Studio Lift, and health coaching services, including a VOD membership, and Live 1:1 personal training, addresses a large consumer base.
• The Company’s management includes industry leaders who bring strength in finance and fitness: Trent Ward, Chief Executive Officer, who had a successful career in finance having worked at Citadel, Deepak Mulchandani, Chief Technology Officer, who was Head of Engineering at Peloton. Recent Insider Buying: Billionaire hedge fund manager Bradley James Wickens has made a series of purchases of shares adding to his investment in FORME: TRNR). Wickens, a UK-based hedge fund manager, started with a 10% ownership stake in FORME, and has since made a series of share purchases and increased his total number of TRNR shares by 150,000 during the month of May.
• European Expansion: FORME recently secured two European partnerships as the Company launches its expansion plan. FORME’s partnerships are with the luxury hotel chain Aethos and sports retail company SIGNA Sports United (NYSE: SSU). Aethos has hotels and clubs across Europe, while SIGNA is based in Germany and serves over 80 online sites. These partnerships will give FORME entry into a new market plus access to an established customer base.
• FORME is differentiated as the only company to offer live 1:1 and asynchronous coaching memberships from the industry’s highest quality personal trainers.
• According to the 2021 Global Wellness Institute, total global spending in the wellness industry in 2020 was $4.4 trillion, of which approximately $740 billion was spent on fitness and other categories of wellness, including yoga, barre, and Pilates.
• Online/digital fitness, fitness apps, fitness equipment, and fitness tracker markets all experienced significant growth due to the pandemic.
• One of the best ways to protect, improve and transform your health is to work with an expert and FORME has hired a team of world-class trainers in the fitness and wellness industry.
• FORME designed their product portfolio to be modular and customizable so that their product and service offerings can be tailored to a broad range of fitness goals, budgets, and needs, thereby accessing a larger addressable market.
• According to the company’s research, they believe their total addressable market includes nearly 10 million households, representing total potential revenue of $18 billion, all of which is in the United States.

MORE CATALYSTS

This one has some major news from late last year that is worth researching. It has the potential to be a real game changer for the company in terms of revenues and cash flow.

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.

INTERACTIVE STRENGTH, INC. D/B/A FORME (NASDAQ: TRNR) AMENDS TERMS OF CLMBR ACQUISITION AND EXPECTS TO CLOSE IN JANUARY 2024, CREATING A HIGH-GROWTH, B2B FOCUSED, CONNECTED FITNESS PLATFORM

AUSTIN, TX, Jan 23, 2024 – (NewMediaWire) – – Interactive Strength, Inc. d/b/a FORME (Nasdaq: TRNR) (“TRNR” or “FORME” or “the Company”), maker of premium smart home gyms and provider of virtual personal training services, today announced that it has amended the previously announced definitive agreement to acquire substantially all of the assets of CLMBR, Inc., (“CLMBR”) the maker of the first-to-market connected vertical climber.

The revised agreement specifies a reduction in equity of $1.5 million being issued to CLMBR shareholders and takes into account the debt financing that has been secured to close the transaction. It is expected that the transaction will close by the end of January 2024, but no assurances can be provided with respect to the expected closing.

Trent Ward, Co-Founder and CEO of FORME, said: “Our team has worked hard on executing this transaction and we are excited to be nearing the completion. As I shared previously, we believe this will be a transformational acquisition that can accelerate the Company’s commercialization path and that the combination of these businesses can create tremendous value for our shareholders.” Ward continues, “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.”

Updated investor presentation materials will be shared on the Company’s investor website after the close of the transaction.

Transaction Highlights:

The pending acquisition is expected to yield several strategic and financial benefits, positioning the combined entity for further growth:

* Rationale

– Expected to provide immediate scale in all functions (Sales, Engineering, Logistics, Supply Chain, Corporate Overhead)

– Expected to generate near-term cashflow for TRNR

– Diversifies revenue (products and channels), with significant growth in B2B channel

– Gaining a strong B2B sales and distribution partner in WOODWAY

* Projected financials

– Combined revenue in 2024 is expected to be between $15 million and $20 million

– Run-rate cashflow positive and adjusted EBITDA profitable potentially as early as the fourth quarter of 2024

* Valuation

– Enterprise value of deal (not including earn-out potential) is $15.4 million

– Expected to be between 1.0x and 1.3x EV / Projected 2024 CLMBR revenue

– Expected to be between 3x and 4x EV / Projected 2024 CLMBR EBITDA, as adjusted for synergies

* Structure

– “Asset deal” (acquiring assets and specific liabilities, decreasing unknown risks)

– Sellers are rolling all equity into TRNR and no cash is being taken “off the table”

– “Lock-up” on common shares until the end of October 2024, which is the same lockup period as TRNR pre-IPO shareholders

* Consideration

– $1.5 million of TRNR common equity issued at transaction close

— Number of shares is determined by the VWAP for the ten days before the close of transaction, with min/max of $1.01 and $1.69 per share

— Earn-out potential for achieving certain levels of B2B unit sales in 2024, paid in TRNR common equity

– $3.0 million of non-voting preferred equity that is held back for two years against representations and warranties before converting to TRNR common equity in 2026

– $1.5 million of subordinated debt assumed

– $8.0 million of senior debt assumed, with $1.4 million of senior debt paid down

* Timing

– Expected to close by the end of January 2024, subject to satisfaction of closing conditions

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 antici             pated 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

To learn more about CLMBR, CLICK HERE

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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.

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” until the end of October 2024, similar to pre-IPO shareholders
• The transaction is expected to close as 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.

NEWS

PUBLISHED

NOV 14, 2023

INTERACTIVE STRENGTH INC. D/B/A FORME REPORTS THIRD QUARTER 2023 RESULTS

PUBLISHED

OCT 17, 2023

INTERACTIVE STRENGTH, INC. D/B/A FORME (NASDAQ: TRNR) TO PRESENT AT THE WEBULL LIVE! WITH CORPORATE CONNECT: VIRTUAL CONSUMER TECH WEBINAR

PUBLISHED

OCT 13, 2023

INTERACTIVE STRENGTH, INC. D/B/A FORME ANNOUNCES STRATEGIC PARTNERSHIP WITH HSA/FSA PAYMENT PROVIDER TRUEMED

PUBLISHED

OCT 13, 2023

FORME EYES SUSTAINABLE GROWTH THROUGH CLMBR ACQUISITION USING A B2B/B2C MULTI-CHANNEL STRATEGY TO ‘AVOID MISTAKES OF PELOTON, OTHER STRUGGLING CONNECTED FITNESS COMPANIES’

INTERACTIVE STRENGTH, INC. D/B/A FORME (NASDAQ: TRNR) TO ACQUIRE CLMBR, CREATING A HIGH-GROWTH, B2B FOCUSED, CONNECTED FITNESS PLATFORM

PUBLISHED

AUG 17, 2023

CORRECTION BY SOURCE: GOLDMAN SMALL CAP RESEARCH PUBLISHES NEW RESEARCH REPORT ON INTERACTIVE STRENGTH, INC.

PUBLISHED

AUG 17, 2023

GOLDMAN SMALL CAP RESEARCH PUBLISHES NEW RESEARCH REPORT ON INTERACTIVE HEALTH, INC.

PUBLISHED

AUG 15, 2023

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

PUBLISHED

AUG 15, 2023

INTERACTIVE STRENGTH INC. D/B/A FORME REPORTS SECOND QUARTER 2023 RESULTS

PUBLISHED

AUG 3, 2023

INTERACTIVE STRENGTH INC. (NASDAQ: TRNR D/B/A “FORME”) ANNOUNCES DISTRIBUTION PARTNERSHIP WITH INDUSTRY LEADING INTEGRATED FITNESS SERVICES COMPANY, THE RISHER COMPANIES

PUBLISHED

AUG 2, 2023

STUDY CONFIRMS FORME’S APPROACH TO FITNESS: A DEEPER LOOK INTO A DIGITAL FITNESS COMPANY THAT RECENTLY REPORTED TRIPLING ITS AVERAGE ANNUALIZED RECURRING REVENUE PER HOUSEHOLD

PUBLISHED

JUL 14, 2023

AS ANNUALIZED RECURRING REVENUE PER HOUSEHOLD IN Q1 2023 MORE THAN TRIPLES YOY TO $1,650, ANALYST FIRM ISSUES BUY RATING FOR INTERACTIVE STRENGTH INC. (NASDAQ: TRNR – “FORME”)

PUBLISHED

JUL 12, 2023

INTERACTIVE STRENGTH INC. (NASDAQ: TRNR – “FORME”) SECURES TWO EUROPEAN PARTNERSHIP AS THE FITNESS COMPANY LAUNCHES ITS EXPANSION PLAN

UBLISHED

JUL 6, 2023

INSIDER BUYING: HEDGE FUND LEGEND MAKES A SERIES OF STOCK PURCHASES IN PREMIUM DIGITAL SMART HOME FITNESS COMPANY INTERACTIVE STRENGTH (NASDAQ: TRNR – “FORME”)

PUBLISHED

JUN 12, 2023

INTERACTIVE STRENGTH INC. SECURES $15M CREDIT FACILITY TO SUPPORT INCREASED DEMAND

PUBLISHED

JUN 8, 2023

INTERACTIVE STRENGTH INC. D/B/A FORME REPORTS FIRST QUARTER 2023 RESULTS

PUBLISHED

JUN 1, 2023

TRNR (INTERACTIVE STRENGTH INC. D/B/A FORME) TO PRESENT AT LD MICRO CONFERENCE ON JUNE 7, 2023 IN LOS ANGELES

PUBLISHED

JUN 1, 2023

IS FORME (NASDAQ: TRNR) THE NEXT GENERATION OF AT-HOME FITNESS TECH, COMBINING THE BEST PERSONAL TRAINING WITH ON-THE-GO FITNESS – AT THE RIGHT PRICE?

PUBLISHED

MAY 26, 2023

HOW THIS DIGITAL FITNESS COMPANY (NEW IPO ON NASDAQ) IS DIFFERENTIATED THROUGH DELIVERING THE INDUSTRY’S FIRST AT-HOME PERSONAL TRAINING OFFERING

PUBLISHED

MAY 25, 2023

INTERACTIVE STRENGTH INC. D/B/A FORME TO PRESENT AT THE INVESTOR SUMMIT ON JUNE 1ST

PUBLISHED

MAY 24, 2023

INTERACTIVE STRENGTH INC. D/B/A FORME LAUNCHES EUROPEAN EXPANSION PLAN BY FOCUSING ON STRATEGIC PARTNERSHIP WITH SIGNA SPORTS UNITED

MANAGEMENT TEAM

TRENT A. WARD CHIEF EXECUTIVE OFFICER

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

DEEPAK M. 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.

SINCERELY,

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OUR NEW PROFILE IS:   (NYSE AMERICAN: MAIA)

______________________

LEAD CANDIDATE THIO MAINTAINS UNPRECEDENTED DISEASE CONTROL RATES IN PHASE 2 NON-SMALL CELL LUNG CANCER (NSCLC) CLINICAL TRIAL

MULTIPLE CLINICAL MILESTONES AHEAD FOR THIO-101 PHASE 2 TRIAL

MAIA ENTERS 2024 WITH ROBUST CLINICAL PIPELINE IN MULTIPLE HARD-TO-TREAT CANCER INDICATIONS

FDA GRANTS ORPHAN DRUG DESIGNATION TO MAIA BIOTECHNOLOGY FOR THIO AS A TREATMENT FOR GLIOBLASTOMA.

     -THIS IS THE THIRD ORPHAN DRUG DESIGNATION GRANTED TO THIO, FOLLOWING THE RECEIPT OF ORPHAN DRUG DESIGNATIONS FOR HEPATOCELLULAR CARCINOMA (HCC) AND SMALL-CELL LUNG CANCER (SCLC) IN 2022. RECEIVING THREE DESIGNATIONS HIGHLIGHTS THE FDA’S RECOGNITION OF THIO’S POTENTIAL TO TREAT MULTIPLE TYPES OF CANCERS, INCLUDING RARE ONES LIKE GLIOBLASTOMA

READ THE INVESTOR PRESENTATION HERE

_______________________________________________________________________________________________________________

Hello Everyone,

We have a new NYSE profile for Today’s session.

This is a company that we have profiled in the past at much lower levels.

The last time we looked at it back in late November it traded as low as .91 on the session.

It recently hit 1.60 and is still sitting significantly that Novembers profile price.

There could be significant room to run based on the chart if it were to see some interest and momentum.

Pull up MAIA and start your research on it immediately .

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a first-in-class cancer telomere targeting agent in clinical development for the treatment of Non-Small Cell Lung Cancer (NSCLC) patients with telomerase-positive cancer cells.

THIO is a Unique Direct Telomere Targeting Agent
• Potential to be used in combination with other anticancer and immune therapies
• Dual, novel mechanism of action: telomere targeting + immunogenic
• FDA awarded THIO 2 Orphan Drug Designations: HCC and SCLC!
• Excellent efficacy: achieved complete and durable responses in HCC in vivo models (peer-reviewed published study)

Partnership with Regeneron

• Clinical supply agreement: Regeneron provides Libtayo® for THIO-101

• Equivalent to $32M non-dilutive participation (largest financing move to date)

• Potentially expand existing relationship and target new companies

Strong and Growing IP Portfolio

• Potential for receiving NCE marketing exclusivity; 5 patents issued, 12 patent applications pending Next Generation Potential Telomere Targeting Therapeutics
• 84 new molecules engineered in last 12 months; Same mechanism of action as THIO

• MAIA-2021-020, MAIA-2022-012 and MAIA-2021-029 significantly more efficacious
• Follow THIO to commercial stage within 4-5 years

MAIA BIOTECHNOLOGY PROVIDES POSITIVE PHASE 2 CLINICAL UPDATES FOR LEAD ANTICANCER AGENT AND OUTLINES TARGETED MILESTONES FOR 2024

January 17, 2024 9:00am EST

• Lead candidate THIO maintains unprecedented disease control rates in Phase 2 non-small cell lung cancer (NSCLC) clinical trial
• Multiple clinical milestones ahead for THIO-101 Phase 2 trial
• Company enters 2024 with robust clinical pipeline in multiple hard-to-treat cancer indications

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, announced new interim data for its ongoing THIO-101 Phase 2 trial in non-small cell lung cancer (NSCLC) and outlined key clinical milestones for 2024.

In the latest available data from THIO-101 (November 13, 2023), 60 patients had been dosed with THIO in sequential combination with Libtayo®. The patients received either 60mg, 180mg, or 360mg of THIO per dose, and 42 had at least one post baseline assessment completed. The observed disease control was well sustained compared to previous scans.

“We are entering 2024 with strong momentum and great excitement about our programs and pipeline,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “To date, preliminary Phase 2 data on THIO in NSCLC has demonstrated unprecedented rates of disease control and response — measures that vastly outperform the standard of care.”

“In addition to NSCLC, our pipeline of immuno-oncology therapies includes THIO orphan drug designations for multiple hard-to-treat cancers, and our research includes THIO-like second-generation telomere-targeting agents. The main objective for the second-generation program is to discover new compounds with potentially improved specificity towards cancer cells relative to normal cells and with potentially increased anticancer activity,” Dr. Vitoc continued.

“Multiple milestones are on target for 2024 as enrollment continues in THIO-101, including long-term efficacy as a major clinical inflection point.”

Key 2023 Achievements

Positive Preliminary Efficacy Data: Key findings from THIO-101 included:

• 100% preliminary disease control rate (DCR) in second-line and 88% in third-line, in highly difficult-to-treat patients who already progressed through previous lines of treatment.
• DCR across all dose levels met pre-determined statistical requirements earlier than expected to proceed to next stage of the trial.

Third orphan drug designation (ODD) granted to THIO: MAIA’s portfolio of immuno-oncology therapies with ODDs now includes a third hard-to-treat cancer, glioblastoma, the most aggressive and most common type of brain cancer with only limited treatment options.

U.S. FDA Investigational New Drug (IND) Clearance: The FDA cleared U.S.-based evaluation for THIO as part of THIO-101. The trial drew a strong pace of enrollment in 2023 compared with previous NSCLC trials by other drug developers.

Dose Selection: A 180mg/cycle dose of THIO was selected for THIO-101 based on stronger efficacy compared to other doses. The selected dose showed unprecedented disease control and overall response rates for a NSCLC clinical trial.

Next Generation Telomere Targeting Agents: MAIA’s second-generation telomere-targeting program is engaged in research and development for new prodrugs derived from lipid-modified THIO molecules. Capable of acting through similar mechanisms of activity as THIO, the higher potency of these compounds at lower dose levels will be investigated further in 2024.

THIO is the only direct telomere targeting agent currently undergoing clinical development in the field of cancer drug discovery and treatment.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo®) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

FDA GRANTS ORPHAN DRUG DESIGNATION TO MAIA BIOTECHNOLOGY FOR THIO AS A TREATMENT FOR GLIOBLASTOMA

• Third orphan drug designation (ODD) granted to THIO by the FDA; drug also holds ODDs for hepatocellular carcinoma and small cell lung cancer
• Benefits include 7 years of U.S. market exclusivity after drug approval and tax credits for qualified clinical testing
• Expected glioblastoma market growth from $2.2 billion to $3.2 billion globally in the next three years

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, announced today that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation to its lead asset THIO, a cancer telomere-targeting agent, for the treatment of glioblastoma. This is the third orphan drug designation granted to THIO, following the receipt of orphan drug designations for hepatocellular carcinoma (HCC) and small cell lung cancer (SCLC) in 2022.

“We are pleased to receive a third orphan drug designation for THIO, further highlighting FDA’s recognition of THIO’s potential in the treatment of multiple cancer indications, including rare ones such as glioblastoma,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “Each year, globally, more than 300,000 people are diagnosed with brain tumors, of which, 25,000 are in the United States. Glioblastoma represents the majority of these cases in the U.S., with 15,000 new patients diagnosed and more than 10,000 deaths yearly, making it an orphan indication. Given this prevalence there is significant room for growth in the $2.2 billion glioblastoma market, which is expected to reach $3.2 billion globally in the next three years.¹ We consider this ODD an important milestone for our development strategy and for glioblastoma patients who could benefit from a potentially revolutionary therapy.”

“In the data presented to the FDA, THIO successfully penetrated the blood brain barrier (BBB) in syngeneic and humanized mouse models of telomerase-expressing brain cancers. Treatment with THIO resulted in potent anticancer activity and significant expansion of the animal lifespan for several difficult to treat cell lines and xenograft mouse models,” added Sergei Gryaznov, Ph.D., MAIA’s Chief Scientific Officer. “These results stem from THIO’s remarkable mechanism of action and its BBB penetrating property that allows for direct targeting of brain tumors in vivo and potentially in glioblastoma patients.”

“Glioblastoma is the most aggressive and most common type of cancer that originates in the brain. With very limited treatment options available, glioblastoma patients have exceptionally short survival durations, and only 7% remain alive five years after being diagnosed with the condition,”² said Mihail Obrocea, MD, MAIA’s Chief Medical Officer. “We are optimistic about our telomere-targeting agent’s ability to provide clinical benefit in patients with glioblastoma, and we look forward to studying THIO for the treatment of this highly unmet medical indication in a future trial.”

Enrollment is ongoing in a Phase 2 trial of THIO, THIO-101, evaluating the drug candidate in patients with advanced non-small cell lung cancer (NSCLC). THIO is the only direct telomere targeting agent currently in clinical development.

About Orphan Drug Designation

The FDA’s Orphan Drug Act of 1983 was designed to incentivize the development of therapies that demonstrate promise for the treatment of rare (orphan) diseases or conditions. A disease is classified as “rare” if it affects fewer than 200,000 people total in the U.S., or if the cost of developing a drug and making it available in the U.S. for such diseases will exceed any potential profits from its sale due to the small target population size. The FDA’s ODD program provides multiple incentives to make orphan drug development more financially possible for companies to pursue, such as up to seven years of market exclusivity for the approved orphan drug, up to 20 years of 25% federal tax credit for expenses incurred in conducting clinical research within the U.S. and waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs, a value of approximately $2.9 million in 2021.

MAIA BIOTECHNOLOGY REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS AND HIGHLIGHTS RECENT DEVELOPMENT PROGRESS FOR ANTICANCER ASSET THIO

• Substantial THIO program progress including unprecedented disease control rate (DCR) of 100% in second-line non-small cell lung cancer (NSCLC)
• Key THIO findings in gliomas, pediatric brain cancer, and second generation THIO-derived cancer therapies
• Strong pace of enrollment in THIO-101 Phase 2 trial exceeds average enrollment pace in similar NSCLC trials

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, today reported financial results for the third quarter ended September 30, 2023 and key operational updates.

“Our successful and productive third quarter was punctuated by the outstanding data on our lead asset THIO that we recently revealed, and an accelerating pace of enrollment in our THIO-101 Phase 2 trial,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “We are expanding our trial in Europe, and with the FDA’s recent clearance for THIO studies in the U.S. as part of THIO-101, we have reached an essential milestone in the clinical development of THIO. Preliminary efficacy data from the trial is excellent and includes an unprecedented disease control rate (DCR) of 100% in second-line NSCLC treatment, far surpassing the standard of care DCR of 53-64%. We achieved the pre-determined statistical requirements to proceed to the next stage of the trial earlier than expected, and we look forward to sharing our continuing progress in the coming months and into 2024.”

Third Quarter Business Highlights and Recent Developments

THIO Program

Announced 100% Disease Control in Second-Line Non-Small Cell Lung Cancer Demonstrating Impressive Positive Preliminary Efficacy Data: 100% preliminary DCR was observed in second-line and 88% in third-line, in highly difficult-to-treat patients who already progressed through previous lines of treatment. DCRs across all dose levels met the pre-determined statistical requirements earlier than expected to proceed to next stage of the THIO-101 Phase 2 trial.

Highly Potent Anticancer Activity in Gliomas: MAIA’slead asset THIO showed highly potent anticancer activity in models of glioma, an aggressive type of brain tumor that originates from glial cells and is among the most difficult-to-treat cancers. As a monotherapy, THIO demonstrated efficacy in multiple glioma cell lines that had acquired resistance to the current state-of-the-art care temozolomide (TMZ).

THIO as Potential Therapy for Pediatric Brain Cancer: Study data showed THIO’s potent anticancer activity in diffuse intrinsic pontine glioma (DIPG), one of the most aggressive tumors affecting the central nervous system in children. The treatment resulted in noticeably increased tumor sensitivity to immune or ionizing radiation therapies.

Higher Anticancer Potency of Next Generation THIO Conjugates: Positive Investigational New Drug-enabling study data on telomere-targeting agents derived from lipid-modified THIO molecules warrant further in vivo in-depth investigation of THIO-like agents as second generation cancer therapies.

THIO-101 Phase 2 Clinical Trial

U.S. FDA Clearance of THIO IND Application: TheU.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) application enabling THIO to be evaluated in the U.S. as part of THIO-101, the Company’s ongoing global phase 2 clinical study in patients with advanced non-small cell lung cancer (NSCLC). THIO is being tested in sequential combination with a checkpoint inhibitor (CPI) to evaluate anti-tumor activity and immune response in NSCLC patients.

Strong Pace of Enrollment in THIO-101: 49 patients have been dosed to date at a pace of enrollment that is currently exceeding the average enrollment pace in similar NSCLC trials. Out of the 49 patients dosed, 37 have already completed at least one post baseline assessment.

Continuing Positive Preliminary Survival Data: The first 2 subjects dosed on trial (both receiving 3rd line of treatment) reported long term survival of 14.6 and 12.5 months, respectively, at the latest post baseline assessment with no new anti-cancer treatment initiated. Follow up was ongoing for the first subject at the time of data cut-off.

Third Quarter 2023 Financial Results

Cash Position: Cash totaled approximately $6.1 million as of September 30, 2023, compared to $10.9 million in cash as of December 31, 2022.

Research and Development (R&D) Expenses: R&D expenses were approximately $2.6 million for the quarter ended September 30, 2023, compared to approximately $2.3 million for quarter ended September 30, 2022. The increase was primarily related to an increase in scientific research expenses.

General and Administrative (G&A) Expenses: G&A expenses were approximately $2.4 million for the quarter ended September 30, 2023, compared to approximately $1.7 million for the quarter ended September 30, 2022. The increase for the quarter was primarily related to an increase in professional fees related to the write-off of deferred offering costs and an increase in investor relations costs.

Other Income, Net: Other income was approximately $0.08 million for the quarter ended September 30, 2023, compared to other income, net of $0.19 million for the quarter ended September 30, 2022, primarily related to a change in the fair value of warrant liability.

Net Loss: Net loss was approximately $4.9 million, or $0.36 per share, for the quarter ended September 30, 2023, as compared to net loss of approximately $4.9 million, or $0.48 per share, for the quarter ended September 30, 2022. Weighted average shares outstanding were 13,675,802 in the third quarter of 2023, compared to 10,165,622 in the third quarter of 2022.

For additional information on the Company’s financial results for the quarter ended September 30, 2023, please refer to the Form 10-Q filed with the SEC.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to an anti-PD-1 agent will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

MAIA BIOTECHNOLOGY REVEALS NEW DATA SHOWING THIO’S POTENT ANTICANCER ACTIVITY IN AGGRESSIVE PEDIATRIC BRAIN CANCER

OCT 12, 2023 9:20AM EDT

Treatment demonstrates decreased cancer cell proliferation and increased tumor sensitivity to ionizing radiation

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, announced that study data shows THIO’s potent anticancer activity in Diffuse Intrinsic Pontine Glioma (DIPG), one of the most aggressive tumors affecting the central nervous system in children.

The data was recently presented at the Society for Neuro-Oncology’s 2023 Pediatric Neuro-Oncology Research Conference and published in the Neuro-Oncology journal (Volume 25, Issue Supplement_1, June 2023, Page i13). The study evaluated THIO as a potential treatment for DIPG based on inducing direct telomeric DNA damage mediated cancer cell death and activating antitumor immunity in DIPG through the intracellular cGAS/STING pathway, which resulted in noticeably increased tumor sensitivity to immune or ionizing radiation therapies.

Radiotherapy is the only standard of care treatment option for DIPG, yet it is rarely curative. In recent years, several immunotherapy strategies have emerged as potential treatments for DIPG. However, the low mutational burden and rare infiltration of T lymphocytes renders these tumors immunologically “cold” and, therefore, poses challenges for general immunotherapy.

“We have shown that THIO treatment sensitized DIPG cells to ionizing radiation (IR), leading to a significant decrease in DIPG cell proliferation in vitro and in vivo models,” said MAIA’s Chief Scientific Officer Sergei Gryaznov, Ph.D. “These encouraging preclinical studies may support further potential preclinical and clinical development of THIO to be used in combination with IR to treat children with high-risk pediatric brain tumors.”

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer(NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

MAIA BIOTECHNOLOGY ANNOUNCES SHARE REPURCHASE PROGRAM

September 28, 2023 8:01am EDT

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today announced that its Board of Directors has approved a share repurchase program with authorization to purchase up to $800,000 of its Class A common stock through September 2024.

“This share repurchase program demonstrates the confidence we have in our market opportunity and our strategy to invest for long-term growth, which we believe is not reflected in the current market valuation,” said Vlad Vitoc, MAIA’s Chief Executive Officer. “By establishing a repurchase plan, we add another tool to our arsenal that can assist with our future financing efforts, enable us to unlock more of the long-term opportunity we see ahead, and drive sustainable value for all stakeholders.”

With a share repurchase program, MAIA may repurchase shares from time to time through various methods, including in open market transactions, in privately negotiated transactions or otherwise, including through the use of trading plans intended to qualify under Rule 10b5-1 under the Securities Exchange Act of 1934, as amended, in compliance with applicable state and federal securities laws. The timing, as well as the number and value of shares repurchased under the program, will be determined by the Company at its discretion and will depend on a variety of factors, including our assessment of the intrinsic value of the Company’s common stock, the market price of the Company’s common stock, general market and economic conditions, available liquidity, compliance with the Company’s debt and other agreements, applicable legal requirements, the nature of other investment opportunities available to the Company, and other considerations. The Company is not obligated to purchase any shares under the repurchase program, and the program may be suspended, modified, or discontinued at any time without prior notice. The Company expects to fund the repurchases by using cash on hand and expected free cash flow to be generated in the future.

Significant Market Opportunity

• Cancer is the most dominant of the age-related disease categories and has life altering impacts in the lives of patients and their close ones
• The number oF people aged 80 years or older is expectedtotriplebetween 2020 and 2050 to reach 426 million

• Approximately40%ofpeoplealivetodayareprojectedtobediagnosed with a cancer type in their lifetime, and 20% will die of it
• NSCLC is the leading tumor type: Mortality 1.7M / Sales $32B (2022)
• CRCissecond:Mortality1M/Sales$20B(2022)

Clinical Programs

THIO-101: Ph 2 trial THIO + LIBTAYO® (cemiplimab) – enrolling (35 patients dosed to date)

• Go-to-market trial in second line NSCLC
• Objectives: select most efficacious dose and expand into pivotal trial
• Started in 2022 in Australia & Europe; to include US in 2023
• Regeneron clinical supply agreement for Libtayo®
• File for accelerated approval in 2025
• Part A (Safety Lead-in) Complete: No dose-limiting toxicities (DLTs), No Serious Adverse Events (SAE) or Serious Unexpected Suspected Adverse Reactions (SUSAR); Safety profile substantially better than current Standard of Care (SoC)
• Preliminary Survival: first 2 patients dosed in Part A continue to be alive, 12.2 and 11.5 months from treatment initiation; progression free after last dose, 10.2 and 8.5 months respectively, with no new treatment; in real-world clinical practice, observed survival in similar heavily pretreated patients is 3-4 months; weeks without therapy
• Disease Control Rate: 82%; subjects with 1+ post-baseline response assessment (n=11, 06/23/23); DCR for SoC in third line: 25-35%
• Part B (efficacy/dose selection) initiated THIO-102: Ph 2 trial THIO + CPIs

• Go-to-market trial in late line of therapy in multiple tumor. types: Colorectal Cancer (CRC), Hepatocellular Carcinoma (HCC, 90% of primary type of liver cancers), and Solid Tumors of any type (ST)
• 3 umbrellas in each: THIO + Libtayo (REGN); Keytruda (MRK); Tecentriq (Genentech/Roche)
• Objectives: select most efficacious combination by tumor type and expand into pivotal trials (9+ possible market entry indications)
• Start in 2023, to include US, Europe, Asia, etc.
• File for accelerated approvals in 2026 and beyond THIO-103: Ph 2/3 trial of THIO + CPIs

• First line NSCLC and SCLC
• Expand to Breast, Prostate, Pancreatic, Ovarian, Gastric Cancer, etc.

THIO is a Unique Direct Telomere Targeting Agent
• Potential to be used in combination with other anticancer and immune therapies
• Dual, novel mechanism of action: telomere

targeting + immunogenic
• FDA awarded THIO 2 Orphan Drug

Designations: HCC and SCLC!
• Excellent efficacy: achieved complete and durable responses in HCC in vivo models (peer-reviewed published study)

MAIA BIOTECHNOLOGY ANNOUNCES POTENT ANTICANCER ACTIVITY OF THIO IN GLIOMAS

October 10, 2023 8:01 am EDT   CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today announced that its lead asset THIO showed highly potent anticancer activity in gliomas, an aggressive type of brain tumor that originates from glial cells. THIO’s novel dual mechanism of action – direct telomere targeting and immune system activation, has previously demonstrated similar efficacy in multiple types of telomerase-active tumors.

THIO was evaluated in various in vitro and in vivo models of gliomas. The results demonstrate the promising therapeutic role of THIO for the treatment of primary and temozolomide-resistant recurrent gliomas through specific telomerase-mediated induction of telomeric DNA damage in glioma cells

“High grade adult gliomas are among the most difficult-to-treat cancers, with less-than-desirable clinical outcomes. These encouraging results further highlight THIO’s excellent anti-cancer activity across several cancer indications,” said Vlad Vitoc, M.D., MAIA’s Chief Executive Officer. “We look forward to evaluate THIO as a treatment for brain cancer in clinical setting.”

“THIO was effective in the majority of human and mouse glioma cell lines with no apparent toxicity against normal astrocytes. As a monotherapy, THIO demonstrated efficacy in multiple glioma cell lines that had acquired resistance to the current state-of-the art care temozolomide (TMZ). THIO induced apoptosis in several human glioma cell lines that grow as three-dimensional tumor mass-mimicking neurospheres,” said MAIA’s Chief Scientific Officer Sergei Gryaznov, Ph.D. “Additionally, THIO produced telomeric DNA damage responses not only in glioma cell lines, but also in diverse human-derived tumor specimens (PDXs). In vivo, THIO significantly decreased tumor proliferation in glioblastoma xenografts and a PDX model of glioblastoma.”

The reviewed results were published in: Clin Cancer Res (2021) 27 (24): 6800–6814.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

Partnership with Regeneron

• Clinical supply agreement: Regeneron provides Libtayo® for THIO-101

• Equivalent to $32M non-dilutive participation (largest financing move to date)

• Potentially expand existing relationship and target new companies

Strong and Growing IP Portfolio

• Potential for receiving NCE marketing exclusivity; 5 patents issued, 12 patent applications pending

Next Generation Potential Telomere Targeting Therapeutics
• 84 new molecules engineered in last 12

months; Same mechanism of action as THIO • MAIA-2021-020, MAIA-2022-012 and

MAIA-2021-029 significantly moreCefficacious
• Follow THIO to commercial stage within 4-5 years

NEWS

Jan 17, 2024 9:00am EST

MAIA BIOTECHNOLOGY PROVIDES POSITIVE PHASE 2 CLINICAL UPDATES FOR LEAD ANTICANCER AGENT AND OUTLINES TARGETED MILESTONES FOR 2024

Jan 05, 2024 8:00am EST

MAIA BIOTECHNOLOGY TO PRESENT AT BIOTECH SHOWCASE 2024 ON JANUARY 9, 2024

Dec 19, 2023 7:00am EST

MAIA BIOTECHNOLOGY ANNOUNCES DOSE SELECTION IN THIO-101 PHASE 2 CLINICAL TRIAL FOR NON-SMALL CELL LUNG CANCER

PUBLISHED

NOV 17, 2023

MAIA BIOTECHNOLOGY (NYSE: MAIA) HAS RECEIVED FDA ORPHAN DRUG DESIGNATION FOR THIO AS A TREATMENT FOR MOST AGGRESSIVE BRAIN CANCER

PUBLISHED

NOV 15, 2023

MAIA BIOTECHNOLOGY ANNOUNCES $4 MILLION REGISTERED DIRECT OFFERING

Nov 10, 2023 7:01am EST

FDA GRANTS ORPHAN DRUG DESIGNATION TO MAIA BIOTECHNOLOGY FOR THIO AS A TREATMENT FOR GLIOBLASTOMA

Nov 07, 2023 8:15am EST

MAIA BIOTECHNOLOGY REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS AND HIGHLIGHTS RECENT DEVELOPMENT PROGRESS FOR ANTICANCER ASSET THIO

Oct 30, 2023 8:41am EDT

MAIA BIOTECHNOLOGY REVEALS HIGHER ANTICANCER POTENCY OF TELOMERE-TARGETING COMPOUNDS DERIVED FROM THIO

Oct 24, 2023 8:00am EDT

MAIA BIOTECHNOLOGY ANNOUNCES 100% DISEASE CONTROL IN SECOND-LINE NON-SMALL CELL LUNG CANCER DEMONSTRATING IMPRESSIVE POSITIVE PRELIMINARY EFFICACY DATA FOR ONGOING THIO-101 PHASE 2 TRIAL

Oct 19, 2023 8:35am EDT

MAIA BIOTECHNOLOGY TO PRESENT PRELIMINARY SAFETY AND EFFICACY DATA FROM THIO-101 PHASE 2 CLINICAL TRIAL AT EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY CONGRESS 2023

Oct 17, 2023 8:01am EDT

MAIA BIOTECHNOLOGY TO PRESENT LATEST FINDINGS FOR SECOND GENERATION THIO PROGRAM AT TURKISH BIOCHEMICAL SOCIETY’S INTERNATIONAL BIOCHEMISTRY CONGRESS 2023

Oct 12, 2023 9:20am EDT

MAIA BIOTECHNOLOGY REVEALS NEW DATA SHOWING THIO’S POTENT ANTICANCER ACTIVITY IN AGGRESSIVE PEDIATRIC BRAIN CANCER

Oct 10, 2023 11:15am EDT

MAIA BIOTECHNOLOGY ACCELERATES ENROLLMENT IN THIO-101 PHASE II CLINICAL TRIAL AS EFFICACY IS OBSERVED IN DOSED PATIENTS

Oct 10, 2023 8:01am EDT

MAIA BIOTECHNOLOGY ANNOUNCES POTENT ANTICANCER ACTIVITY OF THIO IN GLIOMAS

Oct 03, 2023 8:01am EDT

MAIA BIOTECHNOLOGY ANNOUNCES FDA CLEARANCE OF IND APPLICATION FOR THIO, A FIRST-IN-CLASS TELOMERE TARGETING AGENT FOR THE TREATMENT OF NON-SMALL CELL LUNG CANCER

Sep 28, 2023 8:01am EDT

MAIA BIOTECHNOLOGY ANNOUNCES SHARE REPURCHASE PROGRAM

Aug 08, 2023 8:00am EDT

MAIA BIOTECHNOLOGY REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS AND PROVIDES UPDATES FOR THIO-101 PHASE 2 TRIAL FOR NON-SMALL CELL LUNG CANCER

Jul 11, 2023 8:00am EDT

MAIA BIOTECHNOLOGY REPORTS UPDATES ON DISEASE CONTROL RATES FOR THIO-101 PHASE 2 TRIAL FOR ADVANCED NON-SMALL CELL LUNG CANCER

Jul 10, 2023 8:00am EDT

MAIA BIOTECHNOLOGY REPORTS UPDATES ON PRELIMINARY SURVIVAL DATA FOR THIO-101 PHASE 2 TRIAL FOR ADVANCED NON-SMALL CELL LUNG CANCER

Jun 20, 2023 8:00am EDT

MAIA BIOTECHNOLOGY ANNOUNCES UPDATES IN ENROLLMENT IN PHASE II CLINICAL TRIAL: THIO-101 HAS ENROLLED 29 PATIENTS

Jun 07, 2023 8:00am EDT

MAIA BIOTECHNOLOGY FILES SECOND PATENT FOR NEW TELOMERE-TARGETING MOLECULES PROGRAM

May 08, 2023 8:00am EDT

MAIA BIOTECHNOLOGY REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

Apr 27, 2023 4:10pm EDT

MAIA BIOTECHNOLOGY, INC. ANNOUNCES CLOSING OF PUBLIC OFFERING

Apr 24, 2023 9:06pm EDT

MAIA BIOTECHNOLOGY, INC. ANNOUNCES PRICING OF PUBLIC OFFERING

Apr 20, 2023 8:00am EDT

MAIA BIOTECHNOLOGY REPORTS PRELIMINARY SURVIVAL DATA IN PART A OF THIO-101 PHASE 2 TRIAL FOR NON-SMALL CELL LUNG CANCER

MANAGEMENT TEAM

VLAD VITOC, MD, MBA

CHIEF EXECUTIVE OFFICER AND CHAIRMAN

Dr. Vitoc is our Chairman of Board, Chief Executive Officer, and President. Dr. Vitoc has a broad array of experience across commercial strategic analysis and planning and medical affairs, in which he has 20 years of experience. During that time, Dr. Vitoc has managed and supported over 20 early, launch, and mature stage compounds, which have included targeted therapies and immune therapies across more than 25 tumor types, including colorectal cancer, hepatocellular carcinoma, lung cancer, breast cancer, prostate cancer, and renal cell carcinoma. Vlad received an M.D. from the University of Medicine and Pharmacy “Iuliu Hatieganu”, Cluj-Napoca, Romania, and his M.B.A. from the University of South Carolina.

JOSEPH F. MCGUIRE

CHIEF FINANCIAL OFFICER

Mr. McGuire is our Chief Financial Officer, and he brings over 30 years of experience to MAIA, having served as Chief Financial Officer for several privately held and publicly traded companies in the healt

SERGEI M. GRYAZNOV, PHD

CHIEF SCIENTIFIC OFFICER

Dr. Gryaznov is our Chief Scientific Officer. Dr. Gryaznov is an internationally recognized scientist and expert in the areas of modern drug discovery and development, oncology, telomerase, immune-regulatory therapeutics, nucleosides, nucleotides, DNA and RNA analogues, lipid and other conjugates, small molecules, and nucleic acid based therapeutic agents. Dr. Gryaznov is the co-inventor of a novel telomere-by-telomerase-targeting therapeutic approach to potential cancer treatment and responsible for leading the research team that characterized THIO’s telomere targeting activity, our lead compound in development. Dr. Gryaznov obtained an M.S., with Honors, in Organic Chemistry and a Ph.D. in Chemistry of Natural Products from M.V. Lomonosov Moscow State University. Dr. Gryaznov also completed a post-doctoral fellowship program in Chemistry at Northwestern University in Evanston, IL.

MIHAIL OBROCEA, MD

CHIEF MEDICAL OFFICER

Mihail is a board-certified internist and hematologist/oncologist with over 25 years’ experience in drug development in both academia and pharmaceutical/biotechnology industry. His broad clinical drug development expertise in both hematology and oncology covers equally early and late-stage development of cell therapy, cancer vaccines, monoclonal antibodies, and small molecules. Mihail completed a residency program in internal medicine at Yale University followed by a fellowship program in hematology/oncology at Dartmouth with academic appointment as Instructor of Medicine in the division of Hematology & Oncology at Mary Hitchcock Medical Center and Geisel Medical School at Dartmouth.

He started his career in pharmaceutical industry at Pfizer Oncology leading the CD40 agonist and IGF-1R antibodies projects, which entered in early clinical trials. Subsequently he led the Medical Affairs Oncology group at MedImmune, Gaithersburg MD and later as VP, Clinical Development Oncology at MannKind Corp., Valencia, CA successfully brought into clinic two cancer vaccine programs. As a Global Project Lead for AbbVie Biotherapeutics in Redwood City, CA, he was responsible for the early clinical oncology monoclonal antibody programs and as Head, Medical Sciences at Pharmacyclics, Sunnyvale CA he took part in the commercial launch of ibrutinib (IMBRUVICA™) program in mantle cell lymphoma and chronic lymphocytic leukemia. As VP of Clinical and Medical Affairs at SFJ Pharmaceutical Group, a venture pharma company supported the medical and business operations of the Pfizer Oncology partnership on the Phase 3, pivotal trial which led to the FDA approval of Besponsa® (inotuzumab ozogamicin) in the R/R adult B-cell ALL.

Later as US Clinical Lead at Nanobiotix Corp, a biotechnology company based in Paris, France which develops nanotechnologies for use in radiation oncology, established the US clinical programs and was involved in the strategic business development, investor, and partner interaction. As a Program Lead at Juno Therapeutics Inc and later Celgene he had the US clinical oversight of 2 clinical trials including the registration Ph 3 trial in second line aggressive large B-cell lymphomas of BREYANZI® (lisocabtagene maralucel) an autologous CD19 targeted CAR T program approved in both US and EU in R/R large B-cell lymphoma. More recently, as Project and Clinical Lead at Atara Bio, a T-cell therapy company based in Thousand Oaks, CA he supported the pre-clinical and clinical development of the Atara’s allogeneic CAR T platform for both lymphoma and solid tumor indications.

Mihail published in oncology peer-reviewed literature and is co-author of a couple of books related to cancer vaccines and immunology as well as he holds several patents in the field of biotechnology.

SINCERELY,

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READERS ARE ADVISED TO REVIEW SEC PERIODIC REPORTS: FORMS 10-Q, 10K, FORM 8-K, INSIDER REPORTS, FORMS 3, 4, 5 SCHEDULE 13D.DEDICATED INVESTORS LLC IS COMPLIANT WITH THE CAN SPAM ACT OF 2003. DEDICATED INVESTORS LLC DOES NOT OFFER SUCH ADVICE OR ANALYSIS, AND DEDICATED INVESTORS LLC FURTHER URGES YOU TO CONSULT YOUR OWN INDEPENDENT TAX, BUSINESS, FINANCIAL AND INVESTMENT ADVISORS. INVESTING IN MICRO-CAP AND GROWTH SECURITIES IS HIGHLY SPECULATIVE AND CARRIES AND EXTREMELY HIGH DEGREE OF RISK. IT IS POSSIBLE THAT AN INVESTORS INVESTMENT MAY BE LOST OR IMPAIRED DUE TO THE SPECULATIVE NATURE OF THE COMPANIES PROFILED.THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 PROVIDES INVESTORS A SAFE HARBOR IN REGARD TO FORWARD-LOOKING STATEMENTS. ANY STATEMENTS THAT EXPRESS OR INVOLVE DISCUSSIONS WITH RESPECT TO PREDICTIONS, EXPECTATIONS, BELIEFS, PLANS, PROJECTIONS, OBJECTIVES, GOALS, ASSUMPTIONS OR FUTURE EVENTS OR PERFORMANCE ARE NOT STATEMENTS OF HISTORICAL FACT MAY BE FORWARD LOOKING STATEMENTS. FORWARD LOOKING STATEMENTS ARE BASED ON EXPECTATIONS, ESTIMATES, AND PROJECTIONS AT THE TIME THE STATEMENTS ARE MADE THAT INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES WHICH COULD CAUSE ACTUAL RESULTS OR EVENTS TO DIFFER MATERIALLY FROM THOSE PRESENTLY ANTICIPATED. FORWARD LOOKING STATEMENTS IN THIS ACTION MAY BE IDENTIFIED THROUGH USE OF WORDS SUCH AS PROJECTS, FORESEE, EXPECTS, WILL, ANTICIPATES, ESTIMATES, BELIEVES, UNDERSTANDS, OR THAT BY STATEMENTS INDICATING CERTAIN ACTIONS & QUOTE; MAY, COULD, OR MIGHT OCCUR. UNDERSTAND THERE IS NO GUARANTEE PAST PERFORMANCE WILL BE INDICATIVE OF FUTURE RESULTS. IN PREPARING THIS PUBLICATION, DEDICATED INVESTORS LLC HAS RELIED UPON INFORMATION SUPPLIED BY ITS CUSTOMERS, PUBLICLY AVAILABLE INFORMATION AND PRESS RELEASES WHICH IT BELIEVES TO BE RELIABLE; HOWEVER, SUCH RELIABILITY CANNOT BE GUARANTEED. INVESTORS SHOULD NOT RELY ON THE INFORMATION CONTAINED IN THIS WEBSITE. RATHER, INVESTORS SHOULD USE THE INFORMATION CONTAINED IN THIS WEBSITE AS A STARTING POINT FOR DOING ADDITIONAL INDEPENDENT RESEARCH ON THE FEATURED COMPANIES. DEDICATED INVESTORS LLC HAS NOT BEEN COMPENSATED FOR THIS EMAIL. THE ADVERTISEMENTS IN THIS WEBSITE ARE BELIEVED TO BE RELIABLE, HOWEVER, DEDICATED INVESTORS LLC AND ITS OWNERS, AFFILIATES, SUBSIDIARIES, OFFICERS, DIRECTORS, REPRESENTATIVES AND AGENTS DISCLAIM ANY LIABILITY AS TO THE COMPLETENESS OR ACCURACY OF THE INFORMATION CONTAINED IN ANY ADVERTISEMENT AND FOR ANY OMISSIONS OF MATERIALS FACTS FROM SUCH ADVERTISEMENT. DEDICATED INVESTORS LLC IS NOT RESPONSIBLE FOR ANY CLAIMS MADE BY THE COMPANIES ADVERTISED HEREIN, NOR IS DEDICATED INVESTORS LLC RESPONSIBLE FOR ANY OTHER PROMOTIONAL FIRM, ITS PROGRAM OR ITS STRUCTURE. DEDICATED INVESTORS LLC IS NOT AFFILIATED WITH ANY EXCHANGE, ELECTRONIC QUOTATION SYSTEM, THE SECURITIES EXCHANGE COMMISSION OR FINRA.

OUR NEW PROFILE IS:  (NASDAQ: MODD)

MODULAR MEDICAL ANNOUNCES COLLABORATION WITH GLOOKO

THERE ARE 1.9 MILLION INDIVIDUALS WITH TYPE 1 DIABETES IN THE US.  100% OF PATIENT POPULATION REQUIRE DAILY INSULIN INJECTION. ONLY 1 OUT OF 3 CURRENTLY USE AN INSULIN PUMP

WE HAVE SEEN INSIDERT PURCHASE OVER 575K SHARES IN THE PAST 12 MONTHS WITH ZERO SALES

ACCORDING TO THE DECEMBER INVESTOR PRESENTATION, THE COMPANY IS EXPECTING TO SUBMIT ITS MODD1 DEVICE FOR FDA CLEARANCE THIS MONTH

Hello Everyone,  

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

This is another company that we have never have featured on our newsletter before with an incredible looking chart.

Pull up MODD Immediately.  

Modular Medical, Inc. (Nasdaq:MODD) is a development-stage medical device company that intends to launch the next generation of insulin delivery technology. Using its patented technologies, the company seeks to eliminate the tradeoff between complexity and efficacy, thereby making top quality insulin delivery both affordable and simple to learn. Their mission is to improve access to the highest standard of glycemic control for people with diabetes taking it beyond “superusers” and providing “diabetes care for the rest of us.”

Modular Medical was founded by Paul DiPerna, a seasoned medical device professional and microfluidics engineer. Prior to founding Modular Medical, Mr. DiPerna was the founder (in 2005) of Tandem Diabetes and invented and designed its t:slim insulin pump.

The American Diabetes Association says that “In 2021, 38.4 million Americans, or 11.6% of the population, had diabetes.” It released a report in 2022 that estimated the annual cost of diabetes to be $412.9 billion. 

“People with diagnosed diabetes now account for one of every four health care dollars spent in the U.S.” the report noted.

Citing 2020 data from the Centers for Disease Control and Prevention, MODD points out that 3.6 million Americans require daily insulin — that includes 2.9 million who use multiple daily injections (MDI) and 670,000 who use insulin pumps:

(CGM stands for ‘continuous glucose monitors’)

Of those who use MDI, research firm Seagrove Partners has found that about 25% are “almost pumpers” — “meaning that they have considered going on a pump, understand pump therapy benefits, but want something simpler that doesn’t have all the ‘bells and whistles’.”

That’s where MODD expects to come in. The company believes that existing insulin pumps are geared toward “superusers” and are “prohibitive for many to learn and manage.” 

The pumps have too many complicated features that most diabetics don’t need. This increases costs and puts them out of reach for many. As the tagline on MODD’s website reads, it aims to provide “diabetes care for the rest of us.”

INSIDERS ARE CLEARLY “PUMPED” REGARDING THE FUTURE OF THE COMPANY.  WE HAVE SEEN OVER 575K SHARES PURCHASED IN THE PAST 12 MONTHS WITH ZERO SALES. MODD IS SITTING WELL ABOVE THE 52 WEEK LOW OF .84 AND WAS SITTING AT A BUCK LESS THAN 2 MONTHS AGO.  IT RECENTLY RAN WELL OVER 100% TO HIGHS OF 2.22 AND AT THE 1.70 LEVEL IT IS STILL SITTING UP OVER 70% FROM THE END OF NOVEMBER EVEN AFTER SOME PROFIT TAKING.  

MODD1 — THE ADVANCED INSULIN PUMP DESIGNED TO OPEN ACCESS

New microfluidics technology allows for low-cost pumping of insulin.

New intuitive design makes the product simple to use and easier to prescribe

90 Day Reusable

3 Day Consumable

*****Products are currently under research and development and are not available for investigational use or sale.

MODD1 SYSTEM WILL TRANSFORM THE USER/PROVIDER EXPERIENCE

EASY START

Free samples at point-ofcare, payer support, refill RX at pharmacy.

One hour training with care provider (telehealth or clinician in office)

Red, yellow and green light system on the pump indicate how it’s working.

When ready for mealtime bolus, press the button on the pump and confirm

Easy to remove simply click it off and put it back on freely (adhesive or strap).

After 90 days, seamlessly transfer settings to the next 90-day pump

EASY TO CONNECT

All data is securely stored on the cloud, easily accessed by clinicians, data access will enable coverage for diabetes management time

MODULAR MEDICAL STANDS OUT FROM THE REST

T1D Insulin Pump Comparisons (US Market)

PRODUCT FEATURES	MODD1	T:SLIM X2	MEDTRONIC 760G	OMIPOD DASH
Manufacturer	Modular Medical	Tandem Diabetes Care	Medtronic (MiniMed)	Insulet
Reservoir Size	300 units/3mL	300 units/3mL	300 units/3mL	200 units/2mL
Pump Cost	Pump:$0 3-Day Disposables: $349/mo (PBM Pricing)	Pump:$4,200 Disposables: $134/mo	Pump:$4,600 Disposables: $148/mo	Pump:$0 Disposables: $347/mo (PBM Pricing)
Monitorable Via Cell Phone	Yes	No	Yes	No
External Controller Required	No	No	No	Yes
Charger/Battery	No Charger/Single-use disposable battery provided	Charger Required	Battery Required	Handset Charging Required
Easy to Learn	Yes	No	No	No
Remove & Reattach	Yes	Yes	Yes	No

MODULAR MEDICAL ANNOUNCES COLLABORATION WITH GLOOKO

SAN DIEGO, CA / ACCESSWIRE / December 21, 2023 / Modular Medical, Inc. (Nasdaq:MODD) (“Modular Medical” or the “Company”), a development-stage, insulin delivery technology company seeking to launch the next generation of user-friendly and affordable insulin pump technology, today announced a collaboration agreement with Glooko, Inc., a global leader specializing in connected care and remote patient monitoring for diabetes. Integrating with Glooko will allow clinicians and patients to easily review insulin dosing data from the MODD1 pump, when commercially available. In addition, through Glooko’s platform, Dexcom CGMS users will be able to view their glucose levels in the same accessible format in conjunction with their pump data.

Glooko’s platform has a broad installed base, which has been deployed in over 30 countries and 8,000 clinical locations.

“We are extremely pleased to add the Glooko technology platform to our diabetes care system making it even easier and more cost effective for us to provide this important capability to our clinical and patient base. Glooko’s mission to improve health outcomes of people with chronic conditions through its personalized, intelligent, connected care platform fits perfectly with our vision of providing an easy to use, affordable delivery technology to give more patients access to better care,” said Jeb Besser, CEO of Modular Medical.

About Glooko

Glooko improves health outcomes of people with diabetes and related chronic conditions through its personalized, intelligent, connected care platform. Our proven technologies make lives better by revolutionizing the connection between patients and providers, driving patient engagement and adherence, and accelerating the speed of clinical trials. Glooko is globally deployed in over 30 countries and 8,000+ clinical locations. For more information, please visit glooko.com.

NEWS

DEC 21, 2023 08:00AM

MODULAR MEDICAL ANNOUNCES COLLABORATION WITH GLOOKO

DEC 11, 2023 11:30AM

REGISTRATION IS NOW OPEN FOR TRIBE PUBLIC’S WEBINAR EVENT “DIABETES CARE FOR THE REST OF US.” FEATURING MODULAR MEDICAL CEO ON FRIDAY, DECEMBER 15, 2023

OCT 31, 2023 11:00AM

MODULAR MEDICAL UPDATES TEST PROGRESS AND SUBMISSION TIMELINE

AUG 16, 2023 04:01PM

MODULAR MEDICAL PARTNERS WITH PHILLIPS-MEDISIZE TO EXPAND INSULIN DELIVERY ALTERNATIVES

JUL 06, 2023 08:30AM

MODULAR MEDICAL ANNOUNCES DIABETES INDUSTRY VETERAN DUANE DESISTO WILL JOIN THE BOARD OF DIRECTORS

MAY 25, 2023 04:05PM

MODULAR MEDICAL ANNOUNCES FULL EXERCISE OF UNDERWRITER’S OPTION TO PURCHASE ADDITIONAL SHARES

MAY 16, 2023 08:35AM

MODULAR MEDICAL ANNOUNCES PRICING OF UPSIZED $9.4 MILLION PUBLIC OFFERING

JAN 25, 2023 09:00AM

MODULAR MEDICAL PROVIDES UPDATE ON FDA SUBMISSION STRATEGY

NOV 28, 2022 12:30PM

MODULAR MEDICAL ANNOUNCES PRODUCT TESTING UPDATE

NOV 23, 2022 09:00AM

MODULAR MEDICAL ANNOUNCES PARTICIPATION AT UPCOMING INVESTOR CONFERENCES

OCT 03, 2022 09:00AM

MODULAR MEDICAL PROVIDES PRODUCT UPDATE

SEP 07, 2022 11:00AM

MODULAR MEDICAL ANNOUNCES PARTICIPATION AT UPCOMING INVESTOR CONFERENCES

AUG 11, 2022 09:00AM

DR. ANNE PETERS JOINS THE MODULAR MEDICAL ADVISORY BOARD

JUL 26, 2022 09:00AM

MODULAR MEDICAL APPOINTS KEVIN SCHMID AS CHIEF OPERATING OFFICER

JUN 02, 2022 04:00PM

MODULAR MEDICAL TO PRESENT AT LD MICRO INVITATIONAL XII INVESTOR CONFERENCE

MANAGEMENT TEAM

PAUL DIPERNA

FOUNDER AND PRESIDENT

Paul leads the Modular Medical organization. He possesses over 30 years of experience in the medical device industry as a technologist, business executive and founder of several successful startups. He has been deeply involved in Diabetes care for the past 20 years.

Paul’s early background includes key roles at Baxter Healthcare where he worked in cell separation product design, high volume manufacturing, business development, initial startups to evaluate technology within the spaces between divisions, corporate project management and technical diligence on acquisitions. Upon leaving Baxter in 2003, Paul founded, created the technology, and was CEO and board member for a diabetes delivery innovation that bec

JAMES (JEB) BESSER

CHIEF EXECUTIVE OFFICER

23 year Managing Member, Manchester Management LLC, largest shareholder of Modular Medical, Inc.

25+ years of U.S. public equity and capital markets experience, with a focus in life science and technology

Provided long term strategic planning and due diligence, business development, and investor relations guidance to over 100 public companies

Active involvement in developing Modular Medical’s commercial go to market strategy since 2017

JAMES SULLIVAN

INTERIM CHIEF FINANCIAL OFFICER

Jim leads finance and administrative functions and brings over 30 years of financial management and accounting experience to Modular Medical. Based in Silicon Valley, he is a hands-on, seasoned CFO with significant public-company experience in hardware, software and cloud-services businesses and has completed over 15 financings. He has held CFO positions at MoSys, Inc., Apptera, Inc. and 8×8, Inc. Prior to his tenure as CFO at these companies, he held various positions in the assurance practice at PricewaterhouseCoopers LLP in New York and Silicon Valley. He holds a bachelor of science in accounting from New York University, Stern School of Business and is an active certified public accountant.

SINCERELY,

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

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

OUR NEW PROFILE IS:   (NASDAQ: LQR)

LQR HOUSE REPORTS 458% YOY REVENUE SURGE IN DECEMBER 2023, FUELED BY HOLIDAY ECOMMERCE SUCCESS

LQR  ANNOUNCES THE REPURCHASE OF 703,798 OF ITS SHARES, REPRESENTING 15% OF ITS TOTAL OUTSTANDING 

LQR IMPLEMENTED A 1-FOR-60 REVERSE STOCK SPLIT BACK ON NOVEMBER 30, DRASTICALLY REDUCING THE FLOAT 

INDEX INVESTMENT GROUP ACQUIRES 20% STAKE IN LQR HOUSE 

🎉🥂 Breaking News from LQR House! Thrilled to announce a major milestone – $LQR just secured a $1 million PO for SWOL Tequila!

🇨🇦Get ready, Canadian friends! SWOL Tequila is about to make its mark across the border! 🍁🌵 #SWOLTequila #LQRHouse #CanadianExpansion… pic.twitter.com/CLG4UZHFEi

— LQRHouse (@LqrHouse) January 10, 2024

READ THE INVESTOR PRESENTATION HERE: HTTPS://INVEST.LQRHOUSE.COM/LQR%20HOUSE%20DECK.PDF

_________________________________

Hello Everyone,

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

This is one that we have never brought to your attention before.

Pull up LQR immediately.

The company just dropped a slew of news over the past few weeks.

This one has been on the move since completing a 1-60 reverse split back at the end of November.

In mid December it started to take off and has moved over 500% from the $1 level it was sitting at back on the 11th of December.

Interest has been strong and the price has been holding without any significant profit taking.

LQR House intends to become a prominent force in the wine and spirits e-commerce sector, epitomized by its flagship alcohol marketplace, cwspirits.com. This platform seamlessly delivers a diverse range of emerging, premium, and luxury spirits, wines, and champagnes from esteemed retail partners like Country Wine & Spirits. Functioning as a technology-driven hub, LQR House utilizes software, data analytics, and artificial intelligence to elevate the consumer experience. CWSpirits.com stands out as the go-to destination for modern, convenience-oriented shoppers, providing a curated selection of alcohol products delivered to homes across the United States. Beyond its role as an e-commerce leader, LQR House is a marketing agency with a specialized focus on the alcohol industry. The company measures campaign success by directly correlating it with sales on CWSpirits.com, demonstrating a proven return on investment. Backed by an influential network of over 550 figures in the alcohol space, LQR House strategically drives traffic to CWSpirits.com, enhancing brand visibility. LQR House intends to disrupt the traditional landscape of the alcohol industry, driven by its dedication to providing an unparalleled online purchasing experience and delivering tailored marketing solutions.

INDEX INVESTMENT GROUP ACQUIRES 20% STAKE IN LQR HOUSE

GROUP OF INVESTORS LED BY BJARNE BORG TO INCREASE THEIR CURRENT 20% POSITION IN LQR HOUSE

MIAMI BEACH, FL / ACCESSWIRE / January 12, 2024 / Renowned activist investor Bjarne Borg, known for his diverse ventures in real estate, private equity, and energy sectors, has orchestrated a strategic move. Borg’s group of investors is rallying behind LQR House (LQR) amid current market challenges. Analyst organizations, including Fintel, EF Hutton, and Litchfield, project an undervalued status for LQR House with a price target range of $7 to $26.

Borg’s investor group, led by him, has successfully acquired a substantial 20% stake in LQR House, reflecting a profound commitment to the company’s sustained growth. Plans are in place to further increase this position, with the aim of leveraging ownership to instigate positive changes that could enhance share prices by reshaping the narrative in the public market. Drawing on his extensive entrepreneurial experience across industries, Borg intends to guide LQR House through existing challenges. He is prepared to offer assistance, whether through strategic partnerships, potential mergers, or exploring alternative options to public markets if necessary.

Bjarne Borg’s attraction to LQR House stems from its robust ecommerce platform, cwspirits.com, coupled with a low burn rate and an impressive cash reserve exceeding $7.5 million, all while trading at a fraction of its intrinsic value. Notable partnerships and a track record of record-breaking revenue position LQR House as an attractive investment ripe for realizing untapped potential.

Expressing confidence in LQR House, Borg emphasizes its potential to emerge as a disruptor in the alcohol industry. From its NASDAQ IPO, Borg closely monitored the company’s journey, acknowledging current challenges. The objective is to reshape the narrative, steering LQR House towards unlocking its inherent potential and playing a pivotal role in modernizing the alcohol industry.

This strategic investment initiative is positioned as a transformative force, aligning LQR House with a vision that transcends current market challenges and sets the stage for substantial future growth and success.

Through Index Investment Group, founded in 1998, Borg has made significant investments in real estate, spanning residential, commercial, and industrial assets in the United States, Canada, and Sweden. His investments in renewable energy, particularly deep-sea offshore wind and biomass energy power plants, are expected to yield over 20 GW gross output of green energy in the next few years. Index Investment Group, headquartered in Jupiter, FL, has been involved in over thirty developments across North America, with a focus on Florida since 2011. The company owns nearly 3 million square feet of commercial-industrial properties in the upstate New York market. Borg currently holds leadership positions as the Executive Chairman of the Board of Index Investment Group, director of the board of Hexicon Group, and advisory board roles in several national and regional banks.

LQR HOUSE SECURES $1 MILLION PURCHASE ORDER FOR SWOL TEQUILA FROM CANNON ESTATE WINERY

MIAMI BEACH, FL / ACCESSWIRE / January 10, 2024 / LQR House Inc. (the “Company” or “LQR House”) (NASDAQ:LQR), a niche ecommerce platform specializing in the spirits and beverage industry, proudly announces a significant milestone in securing a $1 million purchase order from Cannon Estate Winery(“Cannon” or “Cannon Estate”) for SWOL Tequila.

According to Justin Manuel, a majority owner of Cannon, Cannon Estate is currently developing a high-end lounge in the Fraser Valley, where SWOL will take center stage as the featured tequila. Leveraging key relationships established with leading distributors and retail outlets nationwide, Cannon Estate Winery intends to expand SWOL’s presence across Canada. Given the government-regulated nature of Canada’s alcohol market, Cannon Estate Winery aims to navigate and penetrate essential distribution channels to establish SWOL as a prominent brand beyond borders.

Our strategic collaboration with Cannon has resulted in a $1 million purchase order, which, in our view, lays the foundation for an ongoing expansion plan leveraging Cannon’s established relationships and outlets.

Justin Manuel, a majority owner of Cannon, expresses his confidence in elevating SWOL within the Canadian market. In his own words, “Although Cannon Estate built its business on wine, our goal has always been to expand to other premium spirits. We see ourselves as more of a lifestyle brand and are excited to introduce SWOL to our customers and distributors.”

Sean Dollinger, CEO of LQR House, emphasizes the significance of bringing SWOL Tequila to retail shelves and private clubs across Canada. “Even though e-commerce is at the core of everything we do, it’s important for LQR House to showcase its own brands and the potential they have on their own. As a Canadian, seeing our passion project SWOL Tequila on retail shelves and in private clubs across Canadais a surreal experience. This is only the beginning, as the Company has many plans to increase distribution for SWOL and truly build it into a household name.”

About Cannon Estate Winery

Cannon Estate Winery, emerging as one of Mount Lehman’s fastest-growing vineyards, has successfully brought its wines to retailers across Canada. Cannon Estate Winery products are prominently available at Save on Foods and Everything Wine locations across Canada. Beyond crafting exceptional wines, Cannon Estate Winery’s commitment to sustainability and environmental stewardship sets them apart. The exclusivity of their wine club provides enthusiasts with a unique opportunity to savor creations that embody the essence of the land and the passion behind each bottle, solidifying their position of an important player in the Canadian wine scene.

LQR HOUSE REPORTS 458% YOY REVENUE SURGE IN DECEMBER 2023, FUELED BY HOLIDAY ECOMMERCE SUCCESS

MIAMI BEACH, FL / ACCESSWIRE / January 3, 2024 / LQR House Inc. (the “Company” or “LQR House”) (NASDAQ:LQR), a niche ecommerce platform specializing in the spirits and beverage industry, proudly announces a remarkable 458% YOY increase in revenue for December 2023 compared to December 2022. This achievement aligns with The National Retail Federation’s forecast, projecting record-breaking holiday spending between $957.3 billion and $966.6 billion during November and December 2023.

In December 2022, LQR House recorded revenue at $74,053, and the Company has witnessed a significant growth to $339,713 in December 2023. We believe that this accomplishment is not isolated but part of a broader trend, evidenced by record-breaking sales over the Black Friday to Cyber Monday weekend where November’s monthly revenue surged over 300% year-over-year. In our view, these results indicate that this is not a one-time occurrence for LQR House, but rather, we believe it’s evolving into a recurring situation where LQR House is actively cultivating consistent momentum.

Sean Dollinger, CEO of LQR House, emphasized the significance of the holiday season in ecommerce, stating, “December consistently stands out as the most robust period for ecommerce. Holiday spending tends to escalate, and concurrently, alcohol sales witness a notable rise. We believe, that the year-over-year increase in sales truly attests to the value LQR House brings. Following its remarkable performance in November, the Company replicated its success in December. The aim is to sustain this growth trajectory as we unveil exciting plans ahead to further disrupt the industry and deliver increased value to our shareholders.”

We believe that LQR House continues to solidify its position as a trailblazer in the ecommerce landscape, showcasing rapid growth and innovative strategies to meet the evolving demands of consumers in the spirits and beverage industry.

LQR House announces Record Revenue Numbers for December 2023, reaching $339,713 – a remarkable 458% surge from December 2022's $74,053. This accomplishment is not isolated but aligns with a broader trend. November showcased a record-breaking 300% YoY revenue surge, emphasizing… pic.twitter.com/aaaHNJJBDB

— LQRHouse (@LqrHouse) January 3, 2024

CUSTOM MARKETING STRATEGIES FOR ALCOHOL BRANDS

LQR House has an exclusive marketing agreement with CWSpirits.com, which Includes exclusive rights to marketing on the CWS platform, direct access to the company’s established network of influencers, and rights to sell marketing placements to other brands.

Brands pay LQR to design and market their alcohol products and to create awareness campaigns.

THE CWS PLATFORM IS ONE OF THE LARGEST RETAILERS OF LIQUOR IN THE UNITED STATES, LOCATED AT CWSPIRITS.COM. LQR HOUSE MANAGES ALL MARKETING ACTIVITIES ON THE WEBSITE.

• A vast selection of thousands of the most popular SKUs
• Introduction of up-and-coming brands breaking into the industry
• A substantial customer base with a strong inclination to make purchases
• Vault program: Offers exclusive deals and benefits, akin to Amazon Prime, for online alcohol purchases.
• Utilizing AI for precise brand targeting and improved conversion rates.

LQR HOUSE PROVIDES AN UPDATE ON ITS ONGOING SHARE BUYBACK PROGRAM, REPURCHASING A TOTAL OF 703,798 SHARES

MIAMI BEACH, FL / ACCESSWIRE / January 11, 2024 / LQR House Inc. (the “Company” or “LQR House”) (NASDAQ:LQR), a niche ecommerce platform specializing in the spirits and beverage industry, provides an update on its ongoing share buyback program, affirming its commitment to maximizing shareholder value. Over the last 10 days, LQR House has strategically repurchased 127,085 shares at an average price of $4.2230, adhering to Rule 10b-18 guidelines. This follows the Company’s announcement of repurchasing 576,713 shares at an average share price of $2.4484 in 2023. Even after these transactions, LQR House maintains a strong financial position with over $7.5 million in cash reserves.

Sean Dollinger, CEO of LQR House, emphasizes the Company’s unwavering belief in the substantial undervaluation of its shares. He states, “As mentioned multiple times, the management team still feels that the Company’s shares are extremely undervalued and is doing everything in its capacity to protect shareholders while demonstrating how resilient it truly is. Not only is the Company continuing to buy back shares, but it is also in the process of transferring these shares to certificate form, trying to keep them out of reach of short sellers. We believe that with so much of the float locked up with a handful of majority shareholders and the continued buyback, there is very little available stock causing all of this downward pressure.”

Our belief is that these strategic initiatives underscore LQR House’s commitment to fortifying shareholder confidence and reinforcing the Company’s financial position. The continued share buybacks and proactive measures are integral elements of LQR House’s broader strategy to unlock and showcase the true value of its stock and company as a whole.

NEWS

PUBLISHED

2 DAYS AGO

INDEX INVESTMENT GROUP ACQUIRES 20% STAKE IN LQR HOUSE

PUBLISHED

3 DAYS AGO

LQR HOUSE PROVIDES AN UPDATE ON ITS ONGOING SHARE BUYBACK PROGRAM, REPURCHASING A TOTAL OF 703,798 SHARES

PUBLISHED

4 DAYS AGO

LQR HOUSE SECURES $1 MILLION PURCHASE ORDER FOR SWOL TEQUILA FROM CANNON ESTATE WINERY

PUBLISHED

6 DAYS AGO

LQR HOUSE ANNOUNCES BOARD MEETING FOR A SPECIAL DIVIDEND UP TO $1.00 PER COMMON SHARE

PUBLISHED

2 DAYS AGO

LQR HOUSE ANNOUNCES TRANSFER OF REPURCHASED SHARES TO ITS ACCOUNT HELD BY ITS TRANSFER AGENT FOLLOWING THE COMMENCEMENT OF THE BUYBACK PROGRAM

PUBLISHED

3 DAYS AGO

LQR HOUSE REPORTS 458% YOY REVENUE SURGE IN DECEMBER 2023, FUELED BY HOLIDAY ECOMMERCE SUCCESS

PUBLISHED

DEC 28, 2023

LQR HOUSE ANNOUNCES FULL EXERCISE AND CLOSING OF UNDERWRITERS’ OVER-ALLOTMENT OPTION

PUBLISHED

DEC 27, 2023

LQR HOUSE ANNOUNCES STRATEGIC MARKETING COLLABORATION SHOWCASING DON RAMON TEQUILA IN THE THRIVING $14.40 BILLION TEQUILA MARKET

PUBLISHED

DEC 21, 2023

LQR HOUSE CEO, SEAN DOLLINGER, PURCHASES SHARES IN THE OPEN MARKET, SHOWCASING HIS CONFIDENCE IN THE COMPANY

PUBLISHED

DEC 20, 2023

LQR HOUSE INITIATES WARRANTS CANCELLATION AND COMMITS TO POSTPONE PUBLIC OFFERINGS FOR THE FORESEEABLE FUTURE

PUBLISHED

DEC 19, 2023

LQR HOUSE ANNOUNCES NEW MARKETING CAMPAIGN FOR BAKESALE TO SPOTLIGHT THEIR HOLIDAY FLAVORED LIQUEUR

PUBLISHED

DEC 18, 2023

LQR HOUSE REPURCHASES 499,940 SHARES IN ONGOING SHARE BUYBACK PROGRAM AND SHARES FINTEL’S UPDATED PRICE TARGET OF $306 PER SHARE

PUBLISHED

DEC 15, 2023

LQR HOUSE SUCCESSFULLY ACHIEVES COMPLIANCE WITH NASDAQ MINIMUM BID PRICE REQUIREMENT

PUBLISHED

DEC 13, 2023

LQR HOUSE PARTNERS WITH SODA JERK FOR A NEW CAMPAIGN TO BOOST BUZZ IN THE GROWING RTD BEVERAGES MARKET

PUBLISHED

DEC 11, 2023

LQR HOUSE ANNOUNCES MARKETING PARTNERSHIP WITH BRODY’S CRAFTED COCKTAILS

PUBLISHED

DEC 5, 2023

LQR HOUSE UNVEILS BEVÄGE’S ALL-NEW DIRECT-TO-CONSUMER ECOMMERCE SITE, JUST IN TIME FOR THE HOLIDAY SEASON

PUBLISHED

DEC 1, 2023

LQR HOUSE CEO PARTICIPATES IN THE BENZINGA ALL ACCESS EVENT

PUBLISHED

NOV 30, 2023

LQR HOUSE CELEBRATES RECORD-BREAKING BLACK FRIDAY CYBER MONDAY WEEKEND WITH CWSPIRITS.COM, CONTRIBUTING TO OVER $20 BILLION IN OVERALL CONSUMER SPENDING ONLINE

PUBLISHED

NOV 29, 2023

LQR HOUSE ANNOUNCES ANALYST COVERAGE UPDATES BY LITCHFIELD HILLS RESEARCH REITERATING A BUY RATING AND $5 PRICE TARGET

PUBLISHED

NOV 29, 2023

LQR HOUSE REPURCHASES 3,050,722 SHARES IN ONGOING SHARE BUYBACK PROGRAM

LISHED

NOV 28, 2023

LQR HOUSE ANNOUNCES EFFECTIVE DATE FOR 1-FOR-60 REVERSE STOCK SPLIT AS PART OF NASDAQ COMPLIANCE PLAN

PUBLISHED

NOV 22, 2023

LQR HOUSE ADDRESSES NASDAQ DELISTING DETERMINATION WITH FORMAL APPEAL MEASURES

PUBLISHED

NOV 21, 2023

LQR ANNOUNCES PROPOSED REVERSE SPLIT AS PART OF NASDAQ COMPLIANCE PLAN

PUBLISHED

NOV 20, 2023

LQR HOUSE REPURCHASES 1,476,355 SHARES IN ONGOING SHARE BUY BACK INITIATIVE

MANAGEMENT TEAM

SINCERELY,

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AS OF SEPTEMBER 30, 2023 THE COMPANY HAD $7.4 MILLION IN AVAILABLE CASH; TOTAL CASH INCLUDING RESTRICTED FUNDS WAS $16.8 MILLION

ENVOY MEDICAL BECAME A NASDAQ LISTED COMPANY THROUGH A MERGER WITH ANZU SPECIAL ACQUISITION CORP I, WHICH CLOSED ON SEPTEMBER 29, 2023

THE JOURNAL OF CLINICAL MEDICINE HIGHLIGHTED EARLY SURGICAL EXPERIENCE WITH THE INVESTIGATIONAL ACCLAIM® FULLY IMPLANTABLE COCHLEAR IMPLANT. ACCORDING TO THE PUBLICATION, “ALL THREE SURGERIES PROCEEDED WITHOUT COMPLICATION, AND AT ACTIVATION, ALL THREE PATIENTS WERE HEARING THROUGH THEIR DEVICES

COCH PLANS ON FILING FOR AN INVESTIGATIONAL DEVICE EXEMPTION (IDE) IN EARLY 2024 TO COMMENCE A PIVOTAL CLINICAL TRIAL LATER THIS YEAR

_______________________________

Hello Everyone, 

2023 was an incredible year for us.  We ended the year with a bang after our last profile exploded from .25 all the way to .35 during the session and was even hitting up at .42 in the aftermarket for a strong double digit move.

We have several companies that we want to profile in the coming weeks.  This next one caught fire at the end of the year closing green 18 out of 21 sessions from November into December.

Pull up COCH immediately.  

COCH listed on the Nasdaq back in September by way of a SPAC with Anzu Special Acquisition Corp. 

Envoy Medical Corporation was founded in 1995 as a privately-held hearing health company focused on providing innovative technologies across the hearing health spectrum. They have pioneered one-of-a-kind, fully-implanted devices for hearing loss, including—the fully-implanted Esteem® active middle ear implant available in the U.S. since 2010, and the fully-implanted Acclaim® cochlear implant, an investigational device. They are dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance and ultimately quality of life. 

Envoy believes that the creation of its fully implanted cochlear implant Acclaim will encourage more people with hearing loss to get a cochlear implant, Envoy Medical CEO Brent Lucas said in a news release. The benefits of this technology include patients not needing to charge or change out a battery daily or have external components on their heads.

The technology is currently in clinical trials at Mayo Clinic and has planned trials at other cochlear implant centers in the US. The company expects to see key milestones reached in these trials within the coming quarter, Lucas noted in the release.

“Millions of people have significant hearing loss that may not be adequately treated by hearing aids, a market that we believe will continue to expand as the population ages. We believe that many prospective patients do not seek cochlear implants because they are not satisfied with the currently available options for treatment,”  said Brent Lucas, Chief Executive Officer of Envoy Medical.

In a statement in a recent news release, Anzu CEO Whitney Haring-Smith called Envoy a leader in the cochlear implant industry.

“We believe that Envoy Medical’s Acclaim device may be the first fully implanted cochlear implant commercialized in the United States and is designed to have longer expected battery life than existing competitors,” Haring-Smith said.

The Acclaim

The Acclaim® novel sensor technology is designed to leverage the natural anatomy of the ear rather than a microphone to capture sound entering the ear. The sound vibrations are intended to be processed into customized electronic signals. Then, the stimulator is intended to send unique electrical signals to stimulate the cochlea and hearing nerve to receive sounds.

Designed to function in environments not ideally suited for external components

Designed to use implanted rechargeable battery intended to last several days between charges

Designed without an external artificial microphone.

The device is intended to allow the ear to pick up the sound naturally.

ENVOY MEDICAL PROVIDES THIRD QUARTER 2023 FINANCIAL RESULTS AND BUSINESS UPDATE

Interim Findings from Early Feasibility Trial Provide Important Learnings and Feedback Ahead of Pivotal Clinical Trial Planned for 2024

Virtual Fireside Chat to be held December 7

WHITE BEAR LAKE, Minn., Nov. 20, 2023 (GLOBE NEWSWIRE) —  Envoy Medical, Inc. (“Envoy Medical”) (NASDAQ: COCH), a hearing health company, today is providing a business update and its financial results for the quarter ended September 30, 2023. The Company will host a virtual fireside chat event on December 7, which will cover a range of topics, including introductions to the technology, financial and clinical aspects of the business, as well as potential participation from cochlear implant key opinion leaders.

Envoy Medical is a medical technology company specializing in revolutionary “fully” or “totally” implanted hearing devices. Its propriety sensor technology leverages the unique benefits of the human ear to pick up and relay sound rather than relying on external microphones. Envoy Medical currently has its sights on disrupting what it believes to be a complacent cochlear implant industry with new, fully implanted solutions designed to address well-known shortcomings in existing devices.

The Company’s first product, the Esteem®, remains the only FDA approved fully implanted active middle ear implant. In fact, it is the only fully implanted active hearing device to have received FDA approval for any set of clinical indications. The Esteem® is indicated for use in adults diagnosed with moderate to severe sensorineural hearing loss who no longer benefit from their hearing aids.

Envoy Medical is now leveraging its extensive understanding of fully implanted hearing devices for the development of a fully implanted Acclaim® cochlear implant, an investigational device that is currently in an early feasibility trial at Mayo Clinic in Rochester, Minnesota. The Acclaim® is expected to be the first fully implanted cochlear implant to use the natural ear to pick up sound. The Acclaim® was granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) and is currently considered Investigational (not yet commercially available). A pivotal clinical trial is expected to commence in 2024. Upon FDA approval of the Acclaim® cochlear implant, Envoy Medical intends to target the significantly under-penetrated adult cochlear implant market, which it believes may represent more than an $80 billion opportunity in the US alone.

“The third quarter was transformative for Envoy Medical – we completed a merger to become a publicly traded company on the Nasdaq Stock Exchange, enhanced our balance sheet with new capital, and reported key findings from our Acclaim® Early Feasibility Study conducted at the Mayo Clinic. We believe these accomplishments put Envoy Medical on track to advance our strategic plan over the next several years. Over the next few quarters, we anticipate finalizing our design, filing another Investigational Device Exemption (IDE) with the FDA, launching a pivotal clinical trial and beginning to educate professionals on why we believe fully implanted devices are the future of hearing implants. We are encouraged by the large and underserved adult cochlear implant market with existing strong reimbursement coverage,” said Brent T. Lucas, CEO of Envoy Medical.

“Interim results in the early feasibility study confirmed that we are on the right track with the current design and provided important feedback for final design refinements ahead of our pivotal trial, which are now being implemented. The data provided additional confidence in many aspects of the Acclaim®’s functionality, and also revealed an early indication that the device may improve quality of life for patients. We hope to offer a new and highly differentiated solution that encourages more people who are eligible to receive a cochlear implant to pursue hearing improvement through this important technology.”

Third Quarter and Recent Business Highlights

• Envoy Medical became a Nasdaq Listed company through a merger with Anzu Special Acquisition Corp I, which closed on September 29, 2023. Envoy Medical subsequently began trading its Class A common stock and warrants on the Nasdaq stock exchange under the new ticker symbols “COCH” and “COCHW”, respectively.
• The Journal of Clinical Medicine highlighted early surgical experience with the investigational Acclaim® fully implantable cochlear implant. According to the publication, “All three surgeries proceeded without complication, and at activation, all three patients were hearing through their devices.”
• 6-Month findings from the Early Feasibility Trial demonstrated improved Quality of Life metrics for two of the three participants at three and six months. The third participant’s scores remained stable.
• A signal to noise issue was identified as part of the feasibility trial, which appears to be electrical noise and not body noise or inherent to the Acclaim® architecture. A design update is in progress that is expected to resolve this issue prior to the FDA pivotal trial planned to commence in 2024.
• The Early Feasibility Study also provided an unanticipated discovery related to using a hearing aid in the Acclaim® cochlear implant ear. Envoy Medical intends to explore this further as this would be unique to Acclaim®, which uses the ear to pick up sound while other devices use external or subdermal microphones.
• Initiated efforts with the Minnesota Congressional Delegation to address the CMS’s improper classification of the Envoy Esteem® as a heading aid. Successful reclassification of Esteem® as a fully implanted active middle ear implant could have a material change in reimbursement prospects.
• Announced additional patent award as part of a growing IP portfolio covering current and future implantable hearing device technologies.
• As part of the Nasdaq listing, Envoy Medical appointed a Board of Directors comprised of seven leaders strategically selected from the bio/pharmaceutical, accounting and financial fields. This along with the highly regarded audiologists and surgeons on the existing advisory panel provide world class guidance and counsel to the management team.

Third Quarter Financial Results

• As of September 30, 2023 the Company had $7.4 million in available cash; total cash including restricted funds was $16.8 million.
• Operating costs were $3.5 million for the 3 months ended September 30, 2023, this includes costs associated with the Company’s business combination and Nasdaq listing of approximately $0.4 million.
• Research and Development expense totaled $1.9 million as the Company conducted early feasibility trials and advanced refinements intended to finalize the Acclaim® design ahead of the Company’s pivotal trial, expected to begin in 2024.

“With our new public listing, Envoy Medical enhanced its balance sheet, providing an improved cash position on which to advance our strategic plans,” said David R. Wells, Chief Financial Officer. “We intend to maintain our low-cost operating model, which maximizes our cash resources ahead of our pivotal trial, while also moving ahead on these important corporate matters.”

Upcoming Milestones

Over the next few months, Envoy Medical will continue to advance its efforts on a number of key milestones relating to its clinical progress, including:

• Finalizing and integrating select design enhancements based on the initial feedback and learnings of the Early Feasibility Study.
• Filing for an investigational device exemption (IDE) in early 2024 to commence a pivotal clinical trial later that year.
• Updates pertaining to the continuing efforts underway to properly reclassify its Esteem® as a fully implanted active middle ear implant, and not as a hearing aid. Hearing aids are statutorily excluded from Medicare and Medicaid coverage, and if the Esteem® is properly reclassified as a fully implanted active middle ear implant it can pursue reimbursement coverage, which the Company believes would encourage additional adoption by potential patients.

NEW CLINICAL PUBLICATION REPORTS FIRST THREE PATIENTS IN EARLY FEASIBILITY TRIAL FOR ENVOY MEDICAL’S FULLY IMPLANTED COCHLEAR DEVICE

Surgical Experience with Three Initial Acclaim® Patients Documents Innovation Efforts in the Growing Cochlear Implant Market

WHITE BEAR LAKE, Minnesota, Oct. 19, 2023 (GLOBE NEWSWIRE) — A recent clinical publication in the Journal of Clinical Medicine (JCM) highlighted early surgical experience with Envoy Medical®, Inc.’s (“Envoy Medical”) (NASDAQ: “COCH”) investigational Acclaim® fully implantable cochlear implant. According to the publication, “All three surgeries proceeded without complication, and at activation, all three patients were hearing through their devices. Surgery is more technically challenging compared to a standard cochlear implant, but the skills needed can be mastered by a dedicated otologic surgeon.”

The Company currently expects to file for an investigational device exemption (IDE) in early 2024 to commence a pivotal clinical trial later that year.

Current cochlear implants rely on bulky external hardware that are held in place on the head by a magnet, which can cause discomfort and may not be suitable for all activities, including sleeping, showering, swimming, strenuous activity and other common daily events.

Envoy Medical’s device, the fully implanted Acclaim® cochlear implant seeks to alleviate these limitations by being the first fully implanted cochlear implant (sometimes referred to as a totally implanted cochlear implant or “TICI”). By using an implanted middle ear sensor and an implanted rechargeable power supply, Acclaim® aims to eliminate the need for any externally worn components.

Acclaim® was granted Breakthrough Device Designation from the U.S. Food and Drug Administration(FDA) and is currently in an early feasibility study at Mayo Clinic (Rochester, Minnesota).

Envoy Medical’s Acclaim® may become the first fully implanted cochlear implant to begin a pivotal trial in the United States. Unlike other cochlear implants, Acclaim® intends to leverage the patient’s natural ear – rather than an external microphone – to capture acoustic energy. The Acclaim® is designed to not require the use of an external processor during the day or daily recharging.

“We are excited to see the Mayo Clinic’s team publish on their initial experience with the fully implanted Acclaim® cochlear implant, which we believe will be a significant advancement in a growing but underserved hearing health market,” said Brent Lucas, Envoy Medical’s Chief Executive Officer. “By detailing actual surgical experience, the authors provide cochlear implant specialists an early opportunity to learn about this innovation, the potential quality of life benefits of a fully implanted device, and that the additional surgical steps required likely will not be an impediment to adoption with appropriate training.”

“People often refuse to acknowledge the limitations of the current cochlear implants on the market in public, but in private, they do,” said Lucas, “We believe people want a fully implanted cochlear implant, and we are excited to be pushing the industry in that direction just as companies like Inspire Medical pushed the sleep apnea industry towards a fully implanted solution.”

The Mayo Clinic authors note: “While it is only conjecture at this point, one may presume that increased breadth and comfort of use may improve quality-of-life for many recipients, particularly those who feel their disability prevents them from taking part in certain activities.”

The authors also highlight that this novel device is still developing. Certain patients may not be good candidates and that programming requires careful monitoring.

If approved by the FDA, Envoy Medical intends to target a significantly under-penetrated adult cochlear implant market, which it believes to be more than $80 billion in the US. The paper notes that the success of cochlear implants has resulted in steadily widening the criteria by which patients can qualify for a cochlear device.

The complete study can be found under the citation: Dornhoffer, J.R.; Lawlor, S.K.; Saoji, A.A.; Driscoll, C.L.W. Initial Experiences with the Envoy Acclaim® Fully Implanted Cochlear Implant. J. Clin. Med. 2023, 12, 5875. https://doi.org/10.3390/jcm12185875

NEWS

PUBLISHED

DEC 4, 2023

ENVOY MEDICAL TO HOST FIRESIDE CHAT EVENT DECEMBER 7

PUBLISHED

NOV 20, 2023

ENVOY MEDICAL PROVIDES THIRD QUARTER 2023 FINANCIAL RESULTS AND BUSINESS UPDATE

PUBLISHED

NOV 10, 2023

ENVOY MEDICAL ANNOUNCES PUBLICATION OF ADDITIONAL PATENT FOR IMPLANTABLE COCHLEAR SYSTEMS

PUBLISHED

OCT 24, 2023

ENVOY MEDICAL TO PRESENT AT THE EMERGING GROWTH VIRTUAL CONFERENCE NOVEMBER 1

PUBLISHED

OCT 19, 2023

NEW CLINICAL PUBLICATION REPORTS FIRST THREE PATIENTS IN EARLY FEASIBILITY TRIAL FOR ENVOY MEDICAL’S FULLY IMPLANTED COCHLEAR DEVICE

PUBLISHED

OCT 10, 2023

ENVOY MEDICAL ANNOUNCES SETTLEMENT CONTRACT

PUBLISHED

OCT 3, 2023

ENVOY MEDICAL ANNOUNCES PARTICIPATION IN THE LD MICRO MAIN EVENT XVI

MANAGEMENT TEAM

BRENT LUCAS

CEO

Mr. Lucas has been the Chief Executive Officer of Envoy Medical Corporation for the last seven years and brings over 15 years of experience in the active implantables in the hearing health industry. He has served in various roles and gained a tremendous amount of specialized experience, working his way up from an intern to CEO. Mr. Lucas received his Bachelor’s Degree from the University of St. Thomas and JD from the Mitchell Hamline School of Law.

DAVID R. WELLS

CFO

Mr. Wells has 20 years of experience in the small-cap public company arena. Mr. Wells joined Envoy Medical, Inc. as its Chief Financial Officer in August, 2023. From 2014 to 2021 he was the CFO of ENDRA Life Sciences Inc. (NASDAQ: NDRA), a publicly traded clinical diagnostics technology company, where he directed ENDRA’s initial public offering (IPO) and subsequently raised an additional $55 million across multiple transactions. In December 2022, David joined the Board of Directors of HeartSciences (NASDAQ: HSCS), which is developing a cardiac device which seeks to bridge today’s “diagnostic gap” in cardiac care by providing effective front-line solutions that assist in the detection of heart disease in at-risk patients.

TOM HOEGH

VP OF R&D

Mr. Hoegh has over 30 years of experience in the medical device industry, primarily in the development and on-market support of active implantable devices such as neuromodulation systems for spinal, sacral, deep brain, and hypoglossal nerve stimulation. Mr. Hoegh’s previous experiences consist of leading engineering teams at Nuvectra, ICU/Smiths Medical, Medtronic, and Apnex Medical. Mr. Hoegh received a dual Bachelor of Science degree in Mechanical Engineering and Chemistry from Valparaiso University and a Master of Science degree in Technology Management from the University of St. Thoma

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OUR NEW PROFILE IS:   (NASDAQ: MYMD)

RA AFFECTS UP TO 14 MILLION PEOPLE AROUND THE WORLD

MYMD PHARMACEUTICALS PLANS FDA-CLEARED PHASE 2 CLINICAL TRIAL OF MYMD-1 IN RHEUMATOID ARTHRITIS

MYMD PHARMACEUTICALS REPORTS STATISTICALLY SIGNIFICANT POSITIVE TOPLINE PHASE 2 RESULTS FOR NEXT GENERATION ORAL TNF-Α INHIBITOR MYMD-1® IN SARCOPENIA/AGE-RELATED FRAILTY

VIEW THE INVESTOR PRESENTATION HERE

_______________________________

Hello Everyone, 

We have a brand new profile for today’s session that we want you to pull up immediately.

This one is sitting under .30 right now with major bounce potential.

Pull MYMD right away.

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs.

MYMD PHARMACEUTICALS PLANS FDA-CLEARED PHASE 2 CLINICAL TRIAL OF MYMD-1 IN RHEUMATOID ARTHRITIS

DECEMBER 06, 2023 9:15AM EST

Company targets first quarter 2024 for trial initiation

Potential to be first orally-administered TNF-α inhibitor treatment for RA

BALTIMORE–(BUSINESS WIRE)– MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, announced today that its Investigational New Drug (IND) application for a Phase 2 clinical trial of oral MYMD-1® as a treatment for rheumatoid arthritis (RA) was recently cleared by the U.S. Food and Drug Administration (FDA), and plans are underway for trial launch in the first quarter of 2024.

“With the FDA’s recent clearance of our IND in RA, we are moving forward with plans to initiate a Phase 2 trial within the next several months. Results from preclinical studies have demonstrated MYMD-1’s potential to treat RA, and we believe this drug could one day be a disruptor in the massive market for similar treatments,” said Chris Chapman, M.D., president, director, and chief medical officer of MyMD.

Differentiated by its ease of oral dosing and selectivity, MYMD-1 is a TNF-α inhibitor with a small molecule design that enables the drug to cross the blood brain barrier for entry into the central nervous system. In a preclinical trial, MYMD-1 was shown to significantly reduce swelling and other clinical arthritis measures compared to widely used RA therapy Enbrel® (etanercept).¹ Disease severity (total composite score) was reduced by 47% with MYMD-1 (450 mg/kg/day orally) versus a 37% reduction with etanercept (10 mg/kg by subcutaneous injection).

Under this IND, the Phase 2 clinical trial of MYMD-1 will be a randomized placebo-controlled study that is expected to enroll approximately 60 patients with active rheumatoid arthritis. Patients will receive oral MYMD-1 dosing of 1050 mg.

Market Opportunity

Rheumatoid arthritis is a chronic, systemic inflammatory disorder that causes chronic inflammation of the joints and affects approximately 1.5 million Americans. RA’s cost to society, including healthcare costs; loss of employment; costs to employers, government, and caregivers; and costs associated with a deterioration of quality of life, is estimated to be over $40 billion annually.²

About MYMD-1

Originally developed for autoimmune diseases, MYMD-1’s primary purpose is to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions.

MYMD-1 has shown effectiveness in preclinical and clinical studies in regulating the immune system by performing as a selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation. Unlike other therapies, MYMD-1 has been shown in these studies to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection. MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No approved TNF inhibitor has ever been dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation.

MYMD PHARMACEUTICALS REPORTS STATISTICALLY SIGNIFICANT POSITIVE TOPLINE PHASE 2 RESULTS FOR NEXT GENERATION ORAL TNF-Α INHIBITOR MYMD-1® IN SARCOPENIA/AGE-RELATED FRAILTY

JULY 31, 2023 9:00AM EDT

– MYMD-1 significantly reduced serum levels of chronic inflammatory markers and met all primary pharmacokinetic and secondary safety and tolerability endpoints across multiple doses over 28 days of treatment

– MYMD-1 demonstrated statistical significance across three biomarkers: TNF-α(P=0.008), sTNFR1 (P=0.02), and IL-6 (P=0.03)

– First Oral TNF-α inhibitor, if approved, would offer potential patient benefit in large markets

– Company to present the data to FDA and intends to advance the clinical program for MYMD-1; will hold conference call on August 2, 2023, at 4:30 PM Eastern Time

BALTIMORE–(BUSINESS WIRE)– MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or the “Company”), a clinical stage pharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, today announced statistically significant positive topline results from its randomized Phase 2 study of oral TNF-α inhibitor, MYMD-1^® in patients with chronic inflammation associated with sarcopenia, or age-related frailty. The study met its primary endpoints of significantly reducing chronic inflammatory markers in participants treated with MYMD-1. MYMD-1 has the potential to be the first drug approved by the United States Food and Drug Administration (FDA) for sarcopenia, an age-related decline in physical function which leads to greater risk of hospitalization, disability, and death.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230731983609/en/

The study met both of its primary endpoints, significantly reducing serum levels of three biomarkers, TNF-α (P=0.008), sTNFR1 (P=0.02), and IL-6 (P=0.03) and maintaining appropriate plasma concentrations and parameters in pharmacokinetic evaluations. The study also achieved all secondary endpoints related to safety and tolerability. There were no treatment-related adverse events (AEs) or serious adverse events (SAEs) over the course of the study.

“We are very excited about these results indicating MYMD-1 demonstrated statistically significant reductions in all three inflammatory markers and met all additional pharmacokinetic and safety endpoints needed to advance our sarcopenia clinical program, with guidance from the FDA,” said Chris Chapman, M.D., President, Director, and Chief Medical Officer at MyMD. “These results support the unique advantages of MYMD-1 as the first oral, selective TNF-α inhibitor candidate and potential future treatment option for sarcopenia and other autoimmune conditions such as rheumatoid arthritis.”

The Phase 2 multi-center double-blind, placebo controlled, randomized study (NCT05283486) was designed to investigate the efficacy, tolerability and pharmacokinetics of MYMD-1 in participants aged 65 years or older with chronic inflammation associated with sarcopenia/frailty, a condition linked to elevated levels of proinflammatory cytokines. Patients in the study were dosed weekly with MYMD-1 or placebo over a 28-day period. The study consisted of four dosing cohorts versus placebo (600mg, 750mg, 900mg and 1050mg).

“We are encouraged by the reduction of inflammatory markers along with the favorable safety profile demonstrated in this study of an oral TNF-α inhibitor,” continued Dr. Chapman. “Sarcopenia can significantly affect people as they age, and there are currently no approved treatments for the condition. A selective, oral treatment that reduces TNF-α and inflammation and does not require infusion or injection would be a welcome advance for this population.”

Full results from the study will be presented or published at a later date to be determined. The company plans to initiate discussions with the FDA regarding a Phase 3 study of MYMD-1 in sarcopenia.

NEWS

DEC 06, 2023 9:15AM EST

MYMD PHARMACEUTICALS PLANS FDA-CLEARED PHASE 2 CLINICAL TRIAL OF MYMD-1 IN RHEUMATOID ARTHRITIS 

OCT 04, 2023 7:30AM EDT

MYMD PHARMACEUTICALS TO PRESENT UPDATED STATISTICALLY SIGNIFICANT PHASE 2 DATA FOR MYMD-1, POTENTIAL TNF-Α MARKET DISRUPTER, AT BIOFUTURE 2023 

AUG 14, 2023 8:30AM EDT

FDA ACCEPTS MYMD PHARMACEUTICALS’ INVESTIGATIONAL NEW DRUG APPLICATION (IND) FOR PHASE 2 STUDY OF ORAL TNF-Α INHIBITOR MYMD-1® IN RHEUMATOID ARTHRITIS (RA) 

AUG 02, 2023 8:30AM EDT

MYMD PHARMACEUTICALS TO HOLD CONFERENCE CALL TODAY TO DISCUSS PHASE 2 TRIAL RESULTS 

JUL 31, 2023 9:00AM EDT

MYMD PHARMACEUTICALS REPORTS STATISTICALLY SIGNIFICANT POSITIVE TOPLINE PHASE 2 RESULTS FOR NEXT GENERATION ORAL TNF-Α INHIBITOR MYMD-1® IN SARCOPENIA/AGE-RELATED FRAILTY 

APR 12, 2023 8:30AM EDT

MYMD PHARMACEUTICALS® PROVIDES DOSING UPDATE ON PHASE 2 MULTI-CENTER CLINICAL TRIAL OF MYMD-1® AS A THERAPY FOR DELAYING AGING AND EXTENDING HEALTHY LIFESPAN 

MAR 20, 2023 8:55AM EDT

MYMD PHARMACEUTICALS® AND CHARLES RIVER PRESENT POSITIVE DATA FOR NEXT GENERATION, ORAL TNF-Α INHIBITOR MYMD-1® IN RHEUMATOID ARTHRITIS 

MAR 08, 2023 8:30AM EST

MYMD JOINS LOT NETWORK IN EFFORT TO PROTECT COMPANY AND SHAREHOLDERS FROM PATENT TROLLS 

MAR 02, 2023 8:30AM EST

MYMD ANNOUNCES U.S. DRUG ENFORCEMENT ADMINISTRATION (DEA) DETERMINES SUPERA-CBD™ IS NOT A CONTROLLED SUBSTANCE OR LISTED CHEMICAL 

FEB 28, 2023 8:30AM EST

MYMD PHARMACEUTICALS® ANNOUNCES UPCOMING PRESENTATION OF PRECLINICAL RHEUMATOID ARTHRITIS DATA FOR ORAL TNF-Α INHIBITOR MYMD-1® AT THE SOCIETY OF TOXICOLOGY 2023 ANNUAL MEETING

MANAGEMENT TEAM

CHRIS CHAPMAN, M.D.

President, Chief Medical Officer and Director

Chris Chapman, M.D., was appointed as President and Chief Medical Officer of MYMD Florida effective as of November 1, 2020. Prior to joining MYMD Florida and since 1999, Dr. Chapman has also served as the Chief Executive Officer of Chapman Pharmaceutical Consulting, Inc., a consulting organization that provides support to pharmaceutical and biotech companies in North America, Europe, Japan, India and Africa on issues such as product safety, pharmacovigilance, medical devices, clinical trials and regulatory issues. In addition, from 2003-2004, Dr. Chapman served as the Associate Director of Drug Safety, Pharmacovigilance, and Clinical Operations for Organon Pharmaceuticals, where he was responsible for the supervision of four fellow M.D.s and 10 drug safety specialists. Prior to his time at Organon, Dr. Chapman served as Director, Medical Affairs, Drug Safety and Medical Writing Departments at Quintiles (currently known as IQVIA), from 1995-2003, where he grew the division from no employees to forty employees, including eight board certified physicians, four RNs, two pharmacists, eight medical writers and supporting staff. Dr. Chapman has also served on the board of directors of Rock Creek Pharmaceuticals, Inc. (f/k/a Star Scientific, Inc.) from 2007-2016, including as a member of the Audit Committee from 2007-2014, chairperson of the Compensation Committee from 2007-2014, and chairperson of the Executive Search Committee from 2007 to 2014. Dr. Chapman is an experienced executive and global medical expert and has extensive experience in providing monitoring and oversight for ongoing clinical trials including both adult and pediatric subjects. Dr. Chapman is also the founder of the Chapman Pharmaceutical Health Foundation, an IRS Section 501(c)(3) nonprofit organization established to solicit public funds and to support healthcare needs such as AIDS, diabetes, hypertension, lupus, sickle cell anemia, malaria and tuberculosis, which was organized in 2006. Dr. Chapman is a graduate of the Harvard Kennedy School of Cambridge, Massachusetts for financial management in 2020. Dr. Chapman received his M.D. degree from Georgetown University in Washington, D.C. in 1987, and completed his internship in Internal Medicine, a residency in Anesthesiology and a fellowship in Cardiovascular and Obstetric Anesthesiology at Georgetown.

ADAM KAPLIN, M.D., PH.D.

Chief Scientific Officer

Adam Kaplin, M.D., Ph.D., was appointed Chief Scientific Officer of MYMD Florida effective as of December 18, 2020. Prior to joining MYMD Florida, Dr. Kaplin has served in a number of positions at John Hopkins University, including Principal Neuro-Psychiatric Consultant to the Johns Hopkins Multiple Sclerosis Center of Excellence, Director of the Johns Hopkins Ketamine Clinic and the Departments of Psychiatry & Neurology at Johns Hopkins University School of Medicine, positions he has held at various times from 2002 to present. In addition, since 2019, Dr. Kaplin has served as Adjunct Faculty at the George Mason University Department of Global and Community Health. Dr. Kaplin has also served as Co-Founder of numerous healthcare related startups, including, from 2018 to present, REWARD Pathways Inc., a company devoted to addiction treatment development focused on a combined eHealth and medicine approach to curing addiction, and from 2016 to present, Hollinger Kaplin Benjamin & Bond, an eHealth software development company. Dr. Kaplin’s research focuses on the investigation of the biological basis of immune mediated depression and cognitive impairment by using multiple sclerosis as the model. Dr. Kaplin has also been active for over a decade in the development and application of health information technology to mental health, combining this work with providing neuropsychiatric consultation and ongoing care of patients with multiple sclerosis spectrum disorders. Dr. Kaplin’s original research has been published over 40 times in several different publications, and he has authored or co-authored numerous review articles and textbooks. Dr. Kaplin received his B.S. in Biology from Yale University, graduating cum laude in 1988, and received his M.D. and Ph.D. from the Johns Hopkins University School of Medicine in 1996.

PAUL RIVARD, ESQ.

Executive Vice President of Operations and General Counsel

Paul Rivard, Esq., was appointed Executive Vice President of Operations and General Counsel of MYMD Florida effective as of September 21, 2020. Prior to joining MYMD Florida, Mr. Rivard was a principal shareholder of Banner Witcoff, a national law firm specializing in intellectual property law, from 2003-2020, and in that capacity also served as Chair of the firm’s Prosecution Policies and Procedures Committee, developing and refining internal procedures, workflow, and docketing practices to improve efficiencies and mitigate risk. Before becoming a principal shareholder, Mr. Rivard was an associate at Banner Witcoff from 1998-2002. In addition, prior to his time at Banner Witcoff, Mr. Rivard served as a patent examiner for the United States Patent and Trademark Office from 1992-1998. Mr. Rivard brings more than 20 years of experience as intellectual property counsel for clients ranging from startups to Fortune 100 companies in the life sciences, chemical and consumer product industries, including primary outside intellectual property counsel for MYMD Florida from 2014-2020. Mr. Rivard has worked closely with strategic decision makers and in-house counsel of his numerous clients, seeking to align intellectual property procurement, enforcement and licensing strategies with business objectives. Mr. Rivard received his Juris Doctor from Catholic University of America’s Columbus School of Law, graduating cum laude in 1998, and his B.S. in Chemical Engineering from Clarkson University in 1992.

IAN RHODES

Chief Financial Officer

Ian Rhodes was appointed as Interim Chief Financial Officer on February 1, 2021. Mr. Rhodes joined Brio Financial Group (“Brio”) in January 2021. From March 2020 to December 2020, Mr. Rhodes served as the Interim CFO of Roadway Moving and Storage. From November 2018 to July 2019, he served as Interim CFO of Greyston Bakery and Foundation. From December 2016 to September 2018, Mr. Rhodes served as President, CEO and Director of GlyEco, Inc., and served as CFO of GlyEco, Inc. from February 2016 to December 2016. From May 2014 to January 2016, he served as CFO of Calmare Therapeutics. Mr. Rhodes began his career at PricewaterhouseCoopers, where he worked for 15 years. Mr. Rhodes holds a Bachelor of Science degree in Business Administration with a concentration in Accounting from Seton Hall University and is a licensed CPA in New York.

SINCERELY,

DISCLAIMER

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

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

OUR NEW PROFILE IS:   (NASDAQ: BRSH)

BREAKING NEWS ON FRIDAY:  BRUUSH ORAL CARE INC. AND ARRIVE TECHNOLOGY INC. ANNOUNCE AGREEMENT AND PLAN OF MERGER

BRUUSH IS ENDORSED BY FAMOUS COMEDIAN KEVIN HART

THEY  HAVE RECEIVED OVER 3,000 ORGANIC REVIEWS WITH A 90% 5-STAR RATING

THEIR RETURN RATE IS LESS THAN 1%, COMPARED TO A U.S. NATIONAL AVERAGE RETURN RATE OF 21% FOR ONLINE PURCHASES

THEIR ANNUAL CHURN RATE ON ACTIVE SUBSCRIPTIONS IS ONLY 12%, WHEREAS DOLLAR SHAVE CLUB AND HARRY’S BOTH HAVE AN ANNUAL CHURN RATE OF ALMOST 70%

VIEW THE INVESTOR PRESENTATION HERE

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Hello Everyone,

We wanted to alert you to another exciting profile for Monday’s session.

This one had some incredible merger news on Friday and went viral, closing up 17%, after being up over 100% on the session.

BRSH has developed its sonic-powered Bruush electric toothbrush to make upgrading to an electric brush appealing.

Did you know that when you brush manually, you average only 200 brush strokes a minute while our Brüush provides up to 42,000 sonic vibrations per minute? That’s over 200x more than your manual!

This is a game-changing electric toothbrush that is attracting many subscribers already.

There are now over 38,000 active subscriptions in its brush head refill program and the Company’s internal research demonstrated that over 85% of subscribers are interested in adding Consumables to their existing subscriptions.

Electric toothbrushes are superior to manual, but the majority of people have not switched

• Studies have shown that electric toothbrushes are more effective than manual toothbrushes1
• Despite clear oral care benefits, most people still use a traditional manual toothbrush2
• The low adoption rate shows that consumers do not find the current electric toothbrush value proposition compelling

• They  have received over 3,000 organic reviews with a 90% 5-star rating
• Their return rate is less than 1%, compared to a U.S. national average return rate of 21% for online purchases
• Their annual churn rate on active subscriptions is only 12%, whereas Dollar Shave Club and Harry’s both have an annual churn rate of almost 70%

BRUUSH ORAL CARE INC. AND ARRIVE TECHNOLOGY INC. ANNOUNCE AGREEMENT AND PLAN OF MERGER

VANCOUVER, BC and INDIANAPOLIS, IN / ACCESSWIRE / December 15, 2023 / Bruush Oral Care Inc.(Nasdaq:BRSH) (“Brüush”) and Arrive Technology Inc. (“Arrive”), a technology company focused on facilitating the last inch of the last-mile for autonomous delivery, today announced they have entered into an agreement and plan of merger. The combined company (“Combined Company”) will focus on the advancement and implementation of Arrive’s smart Mailbox-as-a-Service (MaaS) platform that makes the exchange of goods between people, robots and drones frictionless through the use of artificial intelligence (“AI”). The Combined Company is expected to operate under the name Arrive Technology Inc. with its shares listed on the Nasdaq Capital Market under the ticker symbol ‘ARRV’.  

“We are thrilled to announce this proposed merger with Arrive,” remarked Aneil Manhas, Chief Executive Officer of Brüush. “In a world hungry for a future of automated last-mile delivery, there is a critical need for a smart and secure exchange point, which Arrive is poised to redefine with its smart mailbox technology. Arrive’s strong management team, robust IP portfolio and unique Mailbox-as-a-Service platform that integrates artificial intelligence (AI) and machine-learning capabilities, positions the company well to sit at the center of the autonomous delivery network in the evolving landscape of automated exchanges. We reviewed and evaluated numerous strategic alternatives for creating stockholder value and believe this transaction with Arrive presented the most compelling option for our shareholders.”

Arrive’s Chief Executive Officer Dan O’Toole said: “We are excited about becoming Indiana’s 42nd publicly listed company and are confident our AI-powered MaaS platform will deliver excellent value to existing shareholders of both Arrive and Brüush, as well as new shareholders. This agreement and plan of merger will accelerate the development and deployment of our third-generation smart mailbox and continue to support the autonomous delivery revolution.”

About the Transaction, Management and Organization

Under the terms of the merger agreement, Brüush and Arrive will conduct a business combination in the form of a reverse triangular merger (“Merger”) via an all-stock transaction. Brüush (“PubCo”) through its wholly owned subsidiary (“Merger Sub”) will merge with and into Arrive (“Target Company“) with Target Company continuing under the name of Arrive Technology Inc. and as a wholly owned subsidiary of PubCo.

Upon completion of the Merger, the outstanding shares of Target Company’s common stock, will be exchanged for common shares of PubCo representing upon issuance, 94.5% of PubCo’s issued and outstanding common shares on a fully diluted basis. The legacy shareholders of PubCo will own shares of PubCo common shares representing 5.5% of PubCo’s issued and outstanding common shares on a fully diluted basis. The merger has been approved by the board of directors of both companies and is expected to close in the first quarter of 2024, subject to customary closing conditions.

Prior to closing, PubCo will, among other things, effect a reverse stock split with respect to PubCo’scommon shares at a ratio within the range of 6-for-1 to 200-for-1. Additionally, PubCo, will maintain a net cash minimum of US$10,000,000 consisting of cash and cash equivalents after full payment of current liabilities, including any financing and expenses in connection with the Merger. After the closing of the Merger, PubCo will sell, transfer and assign all existing legacy business, assets and liabilities of PubCo to a purchaser and pursuant to that certain separation and distribution agreement to be entered into by and between PubCo and such purchaser on terms and conditions to be mutually agreed by PubCo and such purchaser.

Additional information and details about the transaction will be provided in a Form 6-K which will be filed by Brüush with the Securities and Exchange Commission (“SEC”) and will be available at www.sec.gov.

The Combined Company will focus on advancing Arrive’s existing operations as a technology company with a focus on designing and implementing a Mailbox-as-a-Service platform that facilitates smart, secure and seamless exchange of packages between people, robots and drones. Arrive’s patented smart mailbox system leverages climate-assisted cargo space, smart alerts and advanced chain of custody controls to secure the last inch of the last-mile for all shippers, delivery services and autonomous delivery networks. Arrive’s solutions are critically and uniquely positioned in the supply chain to leverage its unique data assets for artificial intelligence to provide users with machine-learning based insights that can aid businesses and consumers to lower logistical costs and capture new growth opportunities, among other benefits.

Following the consummation of the Merger, the Combined Company will be headquartered in Indianapolis, Indiana and it is anticipated that the Combined Company will be led by current members of the Arrive management team, including:

	●	Dan O’Toole, Chief Executive Officer
	●	Todd Pepmeier, Chief Financial Officer
	●	Mark Hamm, Chief Operations Officer
	●	Torrey Bievenour, Chief Technology Officer
	●	Neerav Shah, Chief Strategy Officer
	●	Lora O’Toole, Vice President Business Development
	●	John Ritchison, Corporate Counsel

The Board of Directors of the Combined Company is expected to consist of five members, one of which will be designated by Brüush and the remainder will be designated by Arrive.

Over the last ten years, subscription companies have become all the rage. These are the companies that send you packages regularly consisting of items you have picked out or they have picked out for you.

BRSH CEO Aneil Manhas believes that the company has done an excellent job of creating a premium product for an affordable price. When you get your Brüush toothbrush, you can immediately tell it is a premium product.

Toothbrush heads should be replaced every 12 weeks — which makes BRSH’s subscription model that sends customers three new brush heads every six months (for about $22) a convenient way to stay on top of changing them.

They’ve grown considerably in popularity due to their convenience. Products range from foods and beverages to household goods, clothing, beauty, books, and more. There’s a subscription for almost everything.

Subscription businesses grew revenues about 5 times faster than S&P 500 company revenues (18.2% versus 3.6%), and U.S. retail sales (14.9% versus 2.3%) from 2012 to 2020.

$600 billion by 2026! How is BRSH aiming to take a piece of this market?

The rapidly growing, direct-to-consumer leader offers subscription-based, aesthetically pleasing electric toothbrushes and oral care products.

The company has a goal to become the go-to oral care brand for millennials and Generation Z, two substantial markets.

How big are these two markets?

Nearly half of Gen Z’ers (46%) and millennials (49%), for instance, were interested in subscriptions on average, compared with about a third (34%) of the general public. 4.7

As you can see with this striking revenue growth disparity, the transformative impact of the subscription model on modern business practice is huge. Looking ahead, the subscription economy is forecast to be worth.

Endorsed by Kevin Hart….

The Bruush toothbrush is a favorite of comedian and actor Kevin Hart who signed up to be company ambassador!

“Together, we are going to take Brüush to the next level of growth and break some of the norms of the category while we are at it.”

– Kevin Hart

NEWS

PUBLISHED

1 DAY AGO

BRUUSH ORAL CARE INC. AND ARRIVE TECHNOLOGY INC. ANNOUNCE AGREEMENT AND PLAN OF MERGER

PUBLISHED

NOV 17, 2023

BRÜUSH RECEIVES NASDAQ NOTIFICATION REGARDING MINIMUM BID REQUIREMENTS

PUBLISHED

OCT 5, 2023

BRÜUSH ANNOUNCES NOTICE FROM NASDAQ FOR CONTINUED LISTING

PUBLISHED

OCT 2, 2023

BRÜUSH ANNOUNCES PRICING OF $5.0 MILLION PRIVATE PLACEMENT

PUBLISHED

JUL 31, 2023

BRÜUSH ORAL CARE INC. ANNOUNCES 1-FOR-25 REVERSE STOCK SPLIT EFFECTIVE PRE-MARKET OPENING ON AUGUST 1, 2023

PUBLISHED

JUL 26, 2023

BRÜUSH ORAL CARE INC. ANNOUNCES RECEIPT OF NOTICE FROM NASDAQ REGARDING THE DETERMINATION OF DELISTING

PUBLISHED

MAY 31, 2023

BRÜUSH TO PRESENT AT THE GRAVITAS 4TH LOS ANGELES SUMMIT

PUBLISHED

APR 18, 2023

BRÜUSH TO PRESENT AT THE SEQUIRE INVESTOR SUMMIT IN PUERTO RICO

PUBLISHED

APR 4, 2023

BRÜUSH APPOINTS NEW CHIEF FINANCIAL OFFICER

PUBLISHED

MAR 22, 2023

BRÜUSH TO CONTINUE TO DISRUPT AT-HOME ORAL CARE WITH UPCOMING NEW PRODUCTS

PUBLISHED

MAR 2, 2023

PARVIS INVEST INC. AND GRAVITAS II CAPITAL CORP. RECEIVE CONDITIONAL APPROVAL OF REVERSE TAKEOVER TRANSACTION AND FILE FILING STATEMENT

PUBLISHED

FEB 28, 2023

BRÜUSH TO PRESENT AT THE GRAVITAS 6TH ANNUAL GROWTH CONFERENCE

MANAGEMENT TEAM

Aneil Manhas, Chief Executive Officer

Aneil Manhas, the founder of the Company, has served as Chief Executive Officer since inception. Mr. Manhas has a career spanning over 15 years working in the financial services industry and in CEO positions of his previous companies

Recently, he was CEO of Surface 604, an electric bike company that he founded in 2015 and grew to be one of North America’s leading e-bike brands. He was also President and CEO of GVA Brands / Rosso Sports, a company he purchased in 2014 and transformed into Canada’s leader in entry-level powersports.

Mr. Manhas previously worked at Credit Suisse in Los Angeles, California for two years as an Investment Banking Analyst before joining Onex Corporation in Toronto, Ontario as a member of the investment team for five years, evaluating and executing large private equity transactions across multiple industries.

Aneil holds an Honours Business Administration (HBA) from the Richard Ivey School of Business at the University of Western Ontario.

Mandeek Manhas, Chief Financial Officer

Mandeek Manhas joined the Company in April 2023 as Chief Financial Officer to direct and oversee the Company’s finance department. Mr. Manhas has over 17 years of experience in a variety of leadership, managerial, financial, accounting, regulatory compliance, assurance, tax and advisory areas. This includes leading initiatives over operational and financial strategy, assessment of growth opportunities, governance and risk management.

Mr. Manhas joins the Company from Shape Properties, a real estate management, development and investment company with over $2.5 billion in asset value under management. As Director of Finance and Accounting for the income producing properties group, he led the finance and accounting functions through budgeting and forecasting, cash management, financial reporting, tax compliance, commercial support and overall growth of the portfolio of assets under management.

Previously, Mr. Manhas was Corporate Controller at Jervois Global (ASX: JRV, TSX-V: JRV), a dual-listed, multinational mining company with advanced development stage and exploration projects, where he led the finance department through a three-way merger with Ecobalt Solutions Inc. (TSX: ECS) and M2 Cobalt Corp. (TSX-V: MC). Prior to this, Mr. Manhas spent eleven years providing audit and advisory services with major accounting firms including Deloitte, Grant Thornton and Crowe MacKay, primarily working with small to mid-market cap corporations listed on Canadian and US exchanges.

Mr. Manhas is a Chartered Professional Accountant and holds a Bachelor of Commerce Degree from the University of British Columbia, with a double major in Finance and Accounting.

Alan MacNevin, Chief Operating Officer

Alan MacNevin joined the Company in June 2022 as Chief Operating Officer and leads the Company across all aspects of operations, driving strategic growth by directing and overseeing the scale of digital commerce, execution of strategic partnerships, launch of new products and expansion into new geographical markets. Mr. MacNevin has over 20 years of experience in executive-level positions managing large teams globally, while leading the growth at start-up e-commerce and subscription-based businesses and building them into category leaders.

Mr. MacNevin joins the Company from Rakuten Kobo, where over the past ten years he has held various executive positions including Chief Revenue Officer (2014-2015), Chief Marketing Officer (2015-2019), and most recently, Chief Operating Officer (2019-2022), where he managed the day-to-day global operations of the company. Driving growth, profitability and international expansion, Mr. MacNevin played a key role in Kobo’s emergence as a dominant player in the eReading industry.

Prior to joining Rakuten Kobo, Mr. MacNevin was a member of the executive team at Sirius Satellite Radio for six years from 2005 to 2011.  At Sirius, Mr. MacNevin led the subscriber management team as the company grew from inception to over two million subscribers before it merged with XM Canada in 2011.  Mr. MacNevin has also held senior marketing and operational roles at the Canadian Broadcasting Company, Chapters-Indigo Online and Bell Mobility.

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