Category: Health

Gilead Deepens Arcus Ties With $320M Investment to Accelerate Cancer Immunotherapy Pipeline

Posted on by slightbourne@noblecapitalmarkets.com

Gilead Sciences and biotech partner Arcus Biosciences announced Tuesday an amended collaboration to accelerate development of their cancer immunotherapy programs, along with a $320 million equity investment by Gilead.

The deal builds on the companies’ 2020 partnership and boosts Gilead’s ownership in Arcus to 33% through an additional stake purchase at $21 per share. Gilead also gains a third seat on Arcus’ board, having their Chief Commercial Officer Johanna Mercier join as a director.

Strategic Focus on TIGIT

A key change is prioritizing late-stage studies for the anti-TIGIT antibody domvanalimab, the lead candidate from the collaboration. Arcus CEO Terry Rosen stated the partners want to “leverage their strengths and focus on efficiently advancing novel combinations.”

Domvanalimab is progressing in Phase 3 for non-small cell lung cancer and gastric/GEJ cancer. By accelerating these pivotal studies, expected to fully enroll by year-end, the drug could reach approval sooner if successful.

However, they are discontinuing the ARC-10 Phase 3 lung cancer trial to devote resources to the other domvanalimab studies targeting greater unmet need.

This streamlining highlights the companies’ faith in TIGIT’s potential but the necessity to optimize their most promising assets. TIGIT is an emerging immunotherapy target and domvanalimab a next-gen asset, so focusing late-stage research is prudent.

Quemliclustat Now Solo Arcus Program

Meanwhile, the planned Phase 3 study of Arcus’ CD73 inhibitor quemliclustat in pancreatic cancer will become an Arcus-only program, no longer jointly developed.

Again the theme is concentrating human capital and financial resources where they can make the biggest difference. For smaller Arcus, independence for some programs provides flexibility.

Arcus can also now fully control projects beyond domvanalimab and their PD-1 drug zimberelimab, which Gilead has options to license. This benefits Arcus’ broader pipeline and product vision.

Extends Arcus Cash Runway

Importantly, the $320 million cash infusion lengthens Arcus’ funding horizon until 2027 by their estimates. This enables advancing Phase 3 quemliclustat and AB154 studies plus potential commercial launch activities without financing concerns.

Any biotech developing novel drugs without revenue benefits immensely from having ample cash reserves. This partly protects Arcus from market volatility and general biotech funding challenges.

Gilead Building a Powerhouse

For Gilead, the enhanced Arcus alliance adds another pillar to their ambitions cancer franchise. The pharma giant has been aggressively wheeling and dealing to expand in oncology, now a key growth area.

Recent moves include the $21 billion Immunomedics acquisition and purchases of companies like Tango Therapeutics, Dragonfly Therapeutics, and Epizyme. The Arcus pact leverages access to next-generation immunotherapy science and pipeline.

Gilead is constructing a vertically integrated oncology player combining in-house and external innovation. Scale and synergies across R&D, manufacturing, and commercialization can accelerate targeted therapies to patients.

With collaborators like Arcus doing the early lifting, Gilead can then optimize late-stage studies and apply their regulatory expertise to reach approvals more quickly.

Overall the amended Arcus agreement highlights Gilead’s commitment to cancer and immunology while bolstering their presence in cutting-edge research like TIGIT inhibition. With the investment and restructuring, Gilead strengthens ties to Arcus’ science while keeping the biotech funded and focused. For both, it’s a win-win accelerating cancer drugs to market.

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Release – GeoVax Announces 1-for-15 Reverse Stock Split to Regain Compliance with Nasdaq Minimum Bid Requirement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Atlanta, GA, January 29, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the Company’s Board of Directors has approved a reverse stock split of its issued and outstanding shares of common stock, par value $0.001 per share (the “Common Stock”), at a ratio of 1-for-15. The Company is effecting the reverse split to regain compliance with the $1.00 minimum bid price required for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The reverse stock split was approved by the Company’s stockholders at a meeting held January 16, 2024.

The reverse stock split will become effective on January 30, 2024 (the “Effective Date”), and the Common Stock is expected to begin trading on the split-adjusted basis on the Nasdaq Stock Exchange (“Nasdaq”) at the market open on January 31, 2024. Following the reverse split, the Common Stock will continue to trade under the symbol “GOVX”, and the Company’s publicly traded warrants will continue to trade under the symbol “GOVXW”.

On the Effective Date, every 15 issued and outstanding shares of the Company’s Common Stock will be converted automatically into one share of the Company’s Common Stock without any change in the par value per share. The total number of issued and outstanding shares of Common Stock will therefore be reduced proportionately from 29,757,823 shares to approximately 1,983,855 shares. On the Effective Date, the publicly traded warrants will be adjusted to require fifteen (15) warrants to be exercised to receive one (1) share of common stock at a price of $75 per share.

Immediately after the reverse stock split, each stockholder’s percentage ownership interest in the Company and proportional voting power will remain unchanged, except for minor changes and adjustments that will result from the rounding up of any fractional shares to the next whole number of shares. The rights and privileges of the holders of shares of Common Stock will be substantially unaffected by the reverse stock split.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact: Investor Relations Contact: Media Contact:
info@geovax.com                paige.kelly@sternir.com                sr@roberts-communications.com 
678-384-7220 212-698-8699 202-779-0929

Release – Unicycive Therapeutics Announces Both An Oral And Poster Presentation To Be Delivered On UNI-494 At The Upcoming AKI And CRRT Conference

Posted on by aweinsoff@channelchek.com

January 29, 2024 7:03am EST 

NEW PRECLINICAL DATA ON UNI-494 IN ACUTE KIDNEY INJURY

LOS ALTOS, Calif., Jan. 29, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced that two presentations related to UNI-494 will be presented at the 29th International Conference on Advances in Critical Care Nephrology AKI and CRRT 2024 taking place March 12-15, 2024, in San Diego, CA.

Shalabh Gupta, MD, Chief Executive Officer of Unicycive, commented, “We are looking forward to presenting data on the efficacy of our second clinical stage program UNI-494 in animal models of delayed graft function, a manifestation of acute kidney injury (AKI) that occurs during kidney transplantation resulting in loss of kidney function. We are also presenting a poster describing our ongoing Phase 1 clinical trial design for UNI-494 in healthy volunteers. Based on the results from this trial, we will determine the best path forward for the program. While our primary focus is on advancing our lead drug, OLC (Oxylanthanum Carbonate) towards a New Drug Application submission, we continue to build a body of data on UNI-494 as it progresses through its first clinical trial.”

  
Title:Intravenous Administration of UNI-494 Ameliorates Acute Kidney Injury in Rat Model of Delayed Graft Function
Lead Author:Satya Medicherla, Ph.D.
Type:Oral Presentation
Date/Time:Tuesday, March 12, 2024 / 5:30 – 7:30 p.m. PT
  
Title:UNI-494 Phase I Safety, Tolerability and Pharmacokinetics: Trial in Progress
Lead Author:Guru Reddy, PH.D.
Type:Poster
Date/Time:March 12th from 5:30 – 7:30 p.m. PT and March 13th from 6:00 – 8:00 p.m. PT
  

About UNI-494

UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. Unicycive is currently conducting a Phase 1 dose-ranging safety study in healthy volunteers in the United Kingdom that is expected to complete this year. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn and YouTube.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

ir@unicycive.com 
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.

Released January 29, 2024

Release – Tonix Pharmaceuticals Announces Conditional Acceptance of Tonmya™ as Trade Name for TNX-102 SL for the Management of Fibromyalgia

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

January 29, 2024 7:00am EST

Results from two positive Phase 3 studies point to Tonmya’s (TNX-102 SL) potential as a new first-line medicine for chronic use in managing fibromyalgia, a debilitating condition suffered by 6-12 million adults in the U.S.

New Drug Application (NDA) submission to the FDA planned for second half of 2024 under the 505(b)(2) regulatory pathway

CHATHAM, N.J., Jan. 29, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the trade name, Tonmya™, for the Company’s drug product candidate TNX-102 SL for the management of fibromyalgia.

Tonmya is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the Company announced highly statistically significant and clinically meaningful topline results in RESILIENT, a second positive Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first positive Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints. Tonix plans to have a pre-NDA meeting with U.S. Food and Drug Administration (FDA) in the first half of 2024 and to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya for the management of fibromyalgia.

“We are very pleased with the FDA’s conditional acceptance of Tonmya as the brand name for TNX-102 SL,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “With this acceptance, we remain excited for what we believe is an important opportunity to offer the first FDA-approved drug for fibromyalgia patients in more than a decade.”

About Tonmya™ (formerly known as TNX-102 SL)

Tonmya is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which is designed for daily administration at bedtime with a proposed mechanism of improving sleep quality in fibromyalgia. Tonmya provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic cholinergic receptors, Tonmya is in development as a daily bedtime treatment for fibromyalgia, fibromyalgia-type Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder, and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary Tonmya composition. These patents are expected to provide Tonmya, upon NDA approval, with U.S. market exclusivity until 2034/2035. In addition, Tonix has pending but not issued U.S. patent applications directed to the transmucosal absorption of CBP-HCl, with U.S. market exclusivity expected until 2033, for treating depressive symptoms in fibromyalgia, with U.S. market exclusivity expected until 2032, and for treating pain in fibromyalgia with U.S. market exclusivity expected until 2041.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA for Tonmya, which has completed two positive Phase 3 studies for the management of fibromyalgia. Tonix intends to meet with the FDA in the first half of 2024 and submit an NDA for the approval of Tonmya for the management of fibromyalgia in the second half of 2024. TNX-102 SL is being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results from a proof-of-concept study were reported in the third quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2024. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome (PWS). TNX-2900 has been granted Orphan Drug designation by the FDA and an investigational new drug (IND) application has been cleared to support a Phase 2 study in PWS patients. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
443-213-0495

Source: Tonix Pharmaceuticals Holding Corp.

Released January 29, 2024

Science 37 to be Acquired by eMed in Deal to Expand Virtual Clinical Trials

Posted on by slightbourne@noblecapitalmarkets.com

Clinical research company Science 37 announced Monday that it has entered into a definitive agreement to be acquired by telehealth provider eMed in a deal valued at approximately $38 million. Under the agreement, eMed will commence a tender offer to purchase all outstanding shares of Science 37 stock for $5.75 per share in cash, representing a 21.3% premium over Science 37’s share price last week.

The deal will allow eMed to leverage Science 37’s remote clinical trial capabilities and proprietary Metasite technology platform to expand patient access and accelerate enrollment for clinical studies. Science 37’s decentralized clinical trial model enables patients to participate from home via telehealth, rather than having to travel to physical trial sites.

This acquisition comes at a pivotal time, as the biotech industry embraces virtual and hybrid trial designs in the wake of the COVID-19 pandemic. Science 37 was an early pioneer in decentralized trials, giving the company a first-mover advantage. According to Science 37 CEO David Coman, “eMed provides the greatest value to our stockholders, customers, patients, and employees. Stockholders will receive a premium, trial sponsors will gain greater access to patients, faster enrollment, and confidence in the Company’s capital position.”

For eMed, the deal significantly expands its digital healthcare footprint, adding Science 37’s network of telehealth investigators, coordinators, and software platform to its existing suite of at-home diagnostics and virtual care services. eMed was an early mover as well, having developed the first at-home COVID-19 test kit in 2020. Since then, the company has expanded into at-home testing and treatment for flu, UTIs, and other conditions.

The combined resources of both companies will provide end-to-end support for decentralized clinical trials, from patient recruitment to at-home sample collection to telemedicine visits. This could be a game-changer in improving patient diversity in trials and enabling studies focused on rare diseases or targeted therapies.

According to Science 37’s latest financial update, the company expects approximately $58-59 million in revenue for 2023 and over $50 million in cash reserves as of December 31, 2023. The company projected 2023 revenue of $50-60 million.

Science 37’s board of directors unanimously approved the acquisition deal with eMed. Major Science 37 shareholders, including Redmile Group, LLC, have also agreed to tender their shares in support of the acquisition.

The deal is expected to close in Q1 2024, pending tender of a majority of outstanding Science 37 shares and satisfaction of other customary closing conditions. Once completed, Science 37 will become a privately held subsidiary of eMed.

This Science 37 acquisition comes on the heels of eMed’s parent company, Evernow Inc., raising $100 million in Series B funding last March. The current deal highlights continued investor appetite for telehealth and digital health companies that are expanding access to care.

In fact, Noble Capital Markets will be hosting a Virtual Healthcare Conference from on April 17-18, 2024, featuring presentations from emerging growth companies in the healthcare sector. The conference will provide a platform for companies to showcase their innovations in digital health, telemedicine, medical devices and more.

The Science 37 and eMed deal also demonstrates the growing intersection between telehealth and clinical research. Other companies like Medable and Excelya are exploring how hybrid and decentralized trials can boost patient recruitment and retention. By meeting patients where they are, virtual trials enable more representative, diverse study populations.

While some industry experts say a hybrid approach will become the standard, decentralized trials are still a relatively new model. This acquisition provides eMed with a first-mover advantage, but expect other digital health companies to underscore their clinical trial offerings moving forward. In the meantime, all eyes will be on eMed and Science 37 as they pioneer the next generation of virtual clinical research.

HEALWELL Makes Big Move into AI-Powered EHR Market Through Intrahealth Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

Healthcare technology firm HEALWELL AI is starting 2024 off strong with the strategic acquisition of Intrahealth Systems, a global provider of electronic health record (EHR) software. This $24 million deal provides HEALWELL with a platform to showcase and scale up its impressive AI capabilities within the massive EHR solutions market.

For investors focused on healthcare tech and AI, this is an exciting play on some of the most promising trends reshaping the industry. As digital health and telemedicine expand rapidly, there is surging demand for next-gen EHR systems equipped with cutting-edge analytics and AI.

HEALWELL is aiming to be at the forefront of this movement by uniting its physician-designed AI with Intrahealth’s established EHR solutions and multi-national customer base.

With over 15,000 clinicians and millions of patients served across Canada, Australia, and New Zealand, Intrahealth boasts an impressive footprint and high-margin recurring revenue exceeding $12 million annually.

HEALWELL plans to turbocharge Intrahealth’s offerings by embedding its own AI-powered clinical decision support software. This technology has already demonstrated major promise in preventative care by enabling earlier disease detection and personalized interventions.

Integrating these AI capabilities into a widely adopted EHR platform like Intrahealth opens up tremendous possibilities to amplify outcomes and lower costs for healthcare providers globally. This direction aligns perfectly with growing adoption of value-based care models that prioritize proactive, tech-enabled, and patient-centric treatment.

For HEALWELL specifically, the benefits of acquiring Intrahealth extend well beyond the technology integration upside. This established player provides HEALWELL with a stable source of profitable SaaS revenue to complement its R&D pipeline. And Intrahealth’s international reach significantly expands HEALWELL’s total addressable market.

The deal also furthers HEALWELL’s broader acquisition-driven strategy focused on consolidating AI, data science, and digital health assets. Intrahealth delivers an ideal platform to demonstrate the power of HEALWELL’s innovations to a large audience of potential customers and partners.

With healthcare spending continuing to spiral globally, there is tremendous appetite for tools that can optimize care and reduce waste. This thematic tailwind, combined with Intrahealth’s impressive financials and HEALWELL’s tech prowess, makes the acquisition look like a savvy move.

Investors can gain valuable insights into the healthcare technology landscape at the upcoming Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference from April 17-18, 2024. This premier small-mid cap event will feature presentations from over 50 public emerging growth companies in the space.

The opportunity in AI-enhanced software platforms like EHR looks especially strong when considering the sheer size of the healthcare IT market. According to Grand View Research, this sector is projected to reach $230 billion by 2028, expanding at nearly 12% annually.

Within this landscape, EHR systems are a central focus, with MarketsandMarkets forecasting this specific niche to be worth $48 billion globally by 2027. First movers with differentiated offerings stand to grab significant market share as adoption of next-gen EHR accelerates.

By snapping up Intrahealth, HEALWELL is positioning itself as a frontrunner in this race to redefine the EHR status quo. Investors interested healthcare technology and AI should keep a close eye on how successfully HEALWELL leverages this strategic acquisition. The company’s progress integrating its robust AI into Intrahealth’s solutions will be an important proof point.

Overall, the Intrahealth deal provides HEALWELL with both an immediate boost in revenue and profitability, plus a long-term growth driver if the combined EHR/AI offering gains traction. This is exactly the sort of calculated, opportunistic move investors should want to see in an emerging healthcare technology leader like HEALWELL.

GC Oncology’s $380M IPO Kickstarts 2024 Biotech Market

Posted on by slightbourne@noblecapitalmarkets.com

The New Year has kicked off with a bang in biotech, as CG Oncology has completed the first initial public offering in the space for 2024. The cancer-focused biotech raised a whopping $380 million in its IPO on the Nasdaq, sailing past its initial target range of $181 million.

CG Oncology priced its shares at $19 apiece, above the $16-18 range it had set ahead of the IPO. The impressive deal is being viewed by many analysts and investors as a positive indicator that the biotech IPO market is rebounding in 2024 after a relatively slow 2023.

The robust demand for CG Oncology stock reflects renewed optimism and openness to investing in early-stage biotech companies, especially those with innovative science and strong leadership teams.

CG Oncology is developing a novel oncolytic virus therapy known as cretostimogene grenadenorepvec for the treatment of non-muscle invasive bladder cancer. Oncolytic viruses represent an exciting new approach in cancer treatment, wherein specially engineered viruses are able to infect and destroy cancer cells directly while also stimulating anti-tumor immune responses.

Cretostimogene grenadenorepvec is an adenovirus that has been engineered to replicate selectively in bladder cancer cells and stimulate the immune system by expressing granulocyte-macrophage colony-stimulating factor (GM-CSF). Early stage clinical data have shown promising signs of efficacy.

The company plans to use the IPO proceeds to fund a Phase 3 clinical trial of its lead candidate as well as earlier stage pipeline programs. Success in the Phase 3 study could support regulatory approval and commercialization.

CG Oncology was founded in 2018 by a veteran team of biotech entrepreneurs and scientists. The company pursued a pre-IPO crossover financing round in 2022, enabling it to build momentum heading into its public debut.

The IPO success places CG Oncology in a strong position to advance its pipeline. With the influx of capital, the company will be able to aggressively pursue its clinical development plans without relying heavily on external partners.

Moreover, the validation and visibility provided by being a public company can potentially help CG Oncology forge productive collaborations and access additional funding in the future.

Looking ahead, the positive investor response to CG Oncology seems likely to pave the way for more biotech IPOs in 2024. A robust IPO market provides fuel for innovation and discoveries that can transform patient lives.

The biotech sector sputtered in 2022, with only around 20 IPOs completed versus more than 50 in 2021. However, sentiment appears to be shifting, perhaps signaling sunnier days ahead.

In addition to favorable market conditions, biotech companies pursuing IPOs seem to be taking valuable lessons from 2022 by tightening focus on fundamentals like drug efficacy and visibility on clinical milestones.

Other than CG Oncology, a host of biotechs have already filed with SEC intentions to go public in 2024, spanning exciting areas like gene therapy, neurology, and synthetic biology.

With fresh capital and investor enthusiasm, the next generation of biotech companies can pursue ambitious goals to develop innovative medicines. More early-stage companies may also gain the funding needed to initiate or advance clinical trials.

CG Oncology’s big IPO pop reflects the right combination of cutting-edge science, unmet medical need, and strong leadership. This formula will likely be replicated by other emerging biotech stars in the making.

In all, the successful CG Oncology IPO kicks off 2024 as a promising year for biotech funding, innovation, and progress against once intractable diseases. Investors and industry observers will be tracking the IPO market closely through the year for signs of sustained momentum. If the appetite for compelling biotech stories persists, it could drive a much-needed renaissance helping to unlock new medical frontiers.

Mark your calendars! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies.
Presenting company slots are available.

NAYA Biosciences Strengthens Pipeline Through Acquisition of Gene Therapy Asset

Posted on by slightbourne@noblecapitalmarkets.com

NAYA Biosciences is expanding its clinical portfolio through the acquisition of an innovative gene therapy program from Florida Biotechnologies focused on treating rare mitochondrial diseases. This binding deal demonstrates NAYA’s strategy to rapidly build pipeline assets in high-potential areas like gene therapy.

NAYA has entered into a binding letter of intent to acquire Florida Biotechnologies for $20 million in NAYA shares, with potential milestone payments up to $5 million more. The deal specifically targets Florida Biotech’s clinical-stage gene therapy for Leber’s Hereditary Optic Neuropathy (LHON).

LHON is a rare mitochondrial genetic disease leading to progressive vision loss and blindness. There are currently no approved treatments. Florida Biotech’s AAV gene therapy aims to deliver functional copies of the mutated gene to restore cellular function.

Encouraging Safety Data

This therapeutic has already demonstrated encouraging safety data in a 28-patient Phase 1 trial conducted by Florida Biotech and the University of Miami’s Bascom Palmer Eye Institute. Building on this initial study, NAYA aims to accelerate Phase 2 development and provide early access to patients.

The therapy delivers the gene of interest inside an adeno-associated virus (AAV) vector containing a mitochondrial targeting sequence. This sequence enables delivery specifically to mitochondria, the key site of pathology in LHON and many other mitochondrial diseases.

Broad Applicability

While the lead indication is LHON, NAYA highlights this approach has potential for various mitochondrial orphan diseases. The platform’s strong intellectual property covers use of different AAV capsids and routes of administration.

This flexibility and the high unmet need enables a streamlined regulatory path, including Regenerative Medicine Advanced Therapy and priority review voucher opportunities. The technology has already received over $6 million in grant funding to date.

The asset aligns with NAYA’s focus on innovative regenerative medicine approaches with near-term clinical potential. Gene therapy represents a key component of NAYA’s strategy to build a pipeline addressing major unmet needs.

Expertise in Developing Gene Therapies

NAYA has extensive in-house expertise to advance the acquired AAV gene therapy through late-stage trials toward commercialization. For example, NAYA Chief Medical Officer Dr. Fred Grossman previously led development of the first approved gene therapy, Glybera, during his time at uniQure.

Florida Biotech co-founder Dr. Peter Kash also joins NAYA’s board, bringing over 36 years of biotech leadership experience, including developing and financing gene therapy pioneer Kite Pharma. This expertise will prove valuable for unlocking the platform’s full potential.

Execution of Broader Growth Strategy

NAYA Biosciences was formed earlier in 2023 through the merger of Clinigence Holdings and 4Front Biotech. This deal created a holding company structure to facilitate pipeline expansion through additional strategic acquisitions.

The Florida Biotechnologies program represents the next step in this growth strategy. NAYA plans to continue acquiring high-potential clinical assets to build a robust portfolio spanning gene therapy, oncology, fertility and other areas.

These efforts support NAYA’s overall mission of providing patients earlier access to transformative therapies. The company aims to take an entrepreneurial approach to aggressively advance new technologies through development.

Pending Merger to Unlock Public Markets

NAYA’s deal to acquire Florida Biotechnologies is contingent upon the completion of NAYA’s previously announced merger with fertility company INVO Bioscience, expected in Q1 2024.

The merger will create a publicly traded life sciences company under the INVO name, providing access to capital to support NAYA’s development programs and commercialization. The combined company is valued at over $100 million.

Conclusion

In summary, NAYA Bioscience’s move to acquire Florida Biotechnologies’ AAV gene therapy strengthens its pipeline and aligns with its strategy to focus on high-potential clinical assets. Leveraging its development expertise, NAYA is positioned to accelerate this innovative therapy toward commercialization and fill an important unmet need for patients with mitochondrial diseases.

Biotech Innovation: Emerging Cancer Vaccines and Investment Potential

Posted on by slightbourne@noblecapitalmarkets.com

Cancer research is rapidly evolving thanks to innovative biotech companies utilizing cutting-edge technology like artificial intelligence. One company at the forefront of this biotech revolution is Evaxion Biotech, which is developing novel personalized cancer vaccines powered by its proprietary AI platform.

As highlighted in a recent company press release, Evaxion is expanding its cancer vaccine pipeline to target a new class of AI-discovered tumor antigens called endogenous retroviruses (ERVs). ERVs are remnants of ancient viruses in our DNA that are often abnormally activated in cancer cells, making them visible targets for cancer vaccines.

Evaxion’s focus on ERV-based vaccines represents a breakthrough, transformative concept in cancer treatment. The company’s AI technology allows for identification of the most relevant ERV targets from patient genomic data, enabling truly personalized cancer vaccines.

Such precision vaccines could provide solutions for cancer patients unresponsive to current immunotherapies like checkpoint inhibitors. Evaxion aims to expedite development of this personalized vaccine approach, with initial proof-of-concept studies beginning mid-2024.

This innovation exemplifies the vast potential of emerging biotech companies to disrupt the cancer treatment landscape. Smaller firms like Evaxion can leverage cutting-edge technology like AI to uncover completely new therapeutic targets and strategies.

Powered by AI-Driven Discovery

Evaxion’s pivot to ERV-based vaccines is powered by its proprietary AI platform, AI-Immunology. This technology integrates advanced computational models that can decode the complexity of the human immune system’s interaction with cancer.

AI-Immunology allows rapid prediction and design of novel immunotherapy candidates. This is lightyears beyond traditional vaccine discovery dependent on lengthy trial-and-error experiments.

Evaxion’s AI technology provides a holistic, personalized approach to identify the most relevant targets and optimal vaccine strategies for each patient. This is key for developing effective cancer immunotherapies against the incredible heterogeneity seen across tumors and patients.

AI-Immunology represents a scalable, adaptable platform that can be applied to infectious diseases as well. Evaxion is also pursuing viral and bacterial vaccines powered by its AI discovery engine.

Other emerging biotech firms are also investing in AI-driven drug development, including companies like Recursion Pharmaceuticals, Exscientia, Insitro, and Valo Health. The massive potential of AI is transforming biopharmaceutical R&D.

Accelerating Innovation

Evaxion aims to accelerate innovation of its AI-discovered cancer vaccines. As indicated in its recent press release, the company has already initiated preclinical ERV vaccine studies, with plans for early proof-of-concept data by mid-2024.

This represents a rapid timeline from discovery to initial validation, enabled by AI-Immunology’s predictive modeling capabilities. Evaxion notes there is already significant interest around its ERV vaccine concept, which may help attract partners and investment to further accelerate development.

The company’s expedited progress exemplifies the ability of emerging biotech firms to move quickly from ideas to validation. Unencumbered by legacy infrastructure, these agile startups can transition discoveries into the clinic at unprecedented speed.

Investment Commentary

Evaxion’s pioneering AI platform and progress on its cancer vaccine pipeline highlights the compelling investment opportunities in emerging biotech companies.

These small firms offer differentiated technologies like AI-Immunology that enable transformative innovation not easily captured within larger pharmaceutical companies. First-mover advantage allows rapid value creation.

However, biotech investment carries significant risk. Clinical failures remain high across the industry. Diversification across a basket of emerging firms helps mitigate risks.

For investors interested in growth opportunities in small-cap biotech companies, the upcoming Noble Capital Markets Virtual Conference on April 17-18th features presentations from emerging healthcare and biotech companies.

The conference provides access to executive management teams from over 50 public microcap companies in the biotech, healthcare, and medical devices sector. It represents an excellent opportunity for exposure to innovative companies shaping the future of healthcare.

Biotech Revolution

We are in the midst of a biotechnology revolution led by innovative emerging firms. New technologies like AI and genomic profiling are unlocking unprecedented insights into disease biology and enabling personalized therapeutics.

Evaxion’s focus on AI-powered cancer vaccines represents just one example of transformative innovation occurring in the biotech sector. Other areas of rapid progress include gene therapies, cell therapies, targeted oncology treatments, and more.

Driven by these technological breakthroughs, the pace of biopharmaceutical advancement today is unprecedented. Venture capital investment in U.S. biotech startups hit record levels in 2021, topping $30 billion across over 1,000 deals.

The industry is positioned for continued expansion as emerging firms translate discoveries into new medicines. For investors, the high-growth biotech sector warrants attention despite its inherent risks.

Careful selection of companies with differentiated technologies like Evaxion’s AI platform can yield exciting returns. Ongoing evaluation of clinical execution remains key, as early scientific promise must still translate to real-world efficacy.

Overall, the biotech arena offers fertile ground for investment in innovation. The upcoming Noble Capital Markets Virtual Healthcare Conference highlights the wealth of emerging firms driving the biotechnology revolution.

Release – ZyVersa Therapeutics Announces Peer-Reviewed Article Supporting the Therapeutic Potential of Targeting ASC Specks During Progression of Alzheimer’s Disease

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Jan 24, 2024

  • Research demonstrated that activation of the inflammasome/ASC speck pathway has a vital role in synaptic degeneration in Alzheimer’s Disease (AD).
  • ZyVersa is developing IC 100, a monoclonal antibody targeting inflammasome ASC specks to block initiation and perpetuation of damaging inflammation in the central nervous system and peripheral tissues.

WESTON, Fla., Jan. 24, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, is pleased to announce that world renowned inflammasome researchers and inventors of ZyVersa’s Inflammasome ASC Inhibitor IC 100 have published a scientific paper in the peer-reviewed journal, Alzheimer’s & Dementia: Translational Research & Clinical Interventions.

In the paper titled, “Association of region-specific hippocampal reduction of neurogranin with inflammasome proteins in postmortem brains of Alzheimer’s disease,” the researchers demonstrated that loss of plasticity and neuronal scaffolding proteins, part of the neurodegenerative process leading to memory and learning deficits in AD, is associated with recruitment of ASC molecules and formation of inflammasome complexes in both neurons and microglia.

“Our data emphasize that the synapse may be more vulnerable when the inflammatory machinery is activated, supporting the potential role of targeting ASC specks during the progression of AD pathology,” said Dr. Regina T. Vontell, Research Assistant Professor and Associate Director, Brain Endowment Bank at the University of Miami Miller School of Medicine.

“Our earlier data demonstrated that ASC correlated with Aβ and p-tau in postmortem cases with AD pathology, and that neurons in areas of the brain that are particularly susceptible to death in the early and intermediate stages of the disease process could be identified through imaging studies with Inflammasome ASC inhibitor IC 100. This further supports the therapeutic potential of targeting ASC in patients with AD,” stated Dr. Robert W. Keane, Professor, Physiology and Biophysics, Neurological Surgery and Microbiology, and Immunology at the University of Miami Miller School of Medicine, and a member of ZyVersa’s Inflammatory Disease Scientific Advisory Board.

Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President, commented, “The research published in Alzheimer’s & Dementia: Translational Research & Clinical Interventions reinforces the therapeutic potential of ZyVersa’s Inflammasome ASC Inhibitor IC 100 in neurological diseases. Preclinical studies have demonstrated reduced inflammatory activity and/or improved outcomes in multiple sclerosis, age-related inflammation, spinal cord injury, and two different models of brain injury.”

To review the publication, Click Here.  

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641        

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
dschemelia@tiberend.com
609-468-9325

Release – MAIA Biotechnology Announces Publication Of International Pct Patent Application Covering Anticancer Telomere-Targeting Compounds

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

January 24, 2024 7:15am EST

  • New patent would extend coverage and expand potential value of MAIA’s telomere-targeting platform globally

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that the World Intellectual Property Organization (WIPO) has published MAIA’s global Patent Cooperation Treaty (PCT) application titled “Dinucleotides and Their Use in Treating Cancer.” These compounds are key next-generation telomere-targeting agents, an important extension of MAIA’s innovative cancer treatment platform.

The international patent application covers potential cancer therapies using dinucleotide compounds that target telomeres in cancer cells, and methods for using the dinucleotide compounds to treat cancers alone or before administration with checkpoint inhibitors (CPIs). The new dinucleotides disclosed in the patent application are telomere-targeting molecules, such as THIO fragments or other THIO analogues.

The PCT system streamlines the process for obtaining patent protection globally. Under the PCT, applicants can seek patent protection in a large number of countries.

“This new IP would expand the value of our telomere-targeting compounds as first-in-class cancer treatments in regions around the world and provide patent coverage through 2043,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “Previous preclinical studies of several of our second-generation telomere-targeting agents have shown highly significant anti-cancer efficacy in multiple in vivo and in vitro models. Importantly, this new coverage would further cement our robust and transformational cancer treatment franchise.”

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 MAIA Biotechnology, Inc.

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 potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240124751468/en/

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology

Released January 24, 2024

YS Biopharma Co., Ltd. (YS) – Supply Disruptions Still Hit the Quarter, But Outlook Remains Strong

Posted on by cpereira@noblefcm.com


Wednesday, January 24, 2024

https://www.ysbiopharm.comSector(s): Healthcare Industry: Biotechnology Full Time Employees: 865 Key Executives Name Title Pay Exercised Year Born Dr. Hui Shao Pres, CEO & Exec. Director N/A N/A 1969 Ms. Chunyuan Wu Chief Financial Officer

Gregory Aurand, Senior Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Reported fiscal Q2 2024 and 1H 2024.  In the fiscal Q2 ended September 30, 2023, YS Biopharma reported revenues of RMB96.82 million, and RMB273.1 million for the first six months of fiscal 2024.  We expected RMB121.8 million and RMB298.1 million, respectively. In the fiscal Q2, the Company reported a net loss of RMB103.7 million, or a loss of RMB1.13 per share, vs. our expected loss of RMB78.7 million, or a loss of RMB0.82 per share.

Revenues were still impacted by Covid-related issues. The Company has been working to improve raw material supply, inventory management and production output. Vaccine production returned to normal levels during the quarter, with the FQ2 expected to be the last quarter impacted by the Covid-related production delays. Management now expects third quarter YSJA vaccine revenues to be more normalized, increasing approximately 50% sequentially.


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Inhibrx Sells Lead Asset INBRX-101 to Sanofi for Up to $2.2 Billion

Posted on by slightbourne@noblecapitalmarkets.com

Biotechnology company Inhibrx announced today that it has entered into a definitive agreement to sell its lead therapeutic candidate, INBRX-101, to French pharmaceutical giant Sanofi in a deal valued at up to $2.2 billion.

INBRX-101 is a recombinant alpha-1 antitrypsin (AAT) therapy being developed for the treatment of alpha-1 antitrypsin deficiency (AATD), a rare genetic disorder that can cause severe lung and liver disease. Under the terms of the agreement, Sanofi will acquire Inhibrx through a merger in which Inhibrx shareholders will receive $30 per share in cash, a contingent value right (CVR) worth up to $5 per share, and one share in a new publicly traded company called Inhibrx Biosciences for every four shares of Inhibrx held.

Inhibrx Biosciences will retain all of Inhibrx’s pipeline assets and infrastructure outside of INBRX-101. This includes several early-stage therapeutic candidates such as INBRX-105 for solid tumors, INBRX-106 for hematologic malignancies, and INBRX-109 for conventional chondrosarcoma. The new company will receive $200 million in cash funding from Sanofi and begin trading publicly after the completion of the merger.

The total potential value of the upfront cash payment, CVR, and Inhibrx’s debt assumption implies an aggregate transaction value of approximately $2.2 billion. Inhibrx shareholders will also own 92% of the equity in the newly formed Inhibrx Biosciences, which will provide opportunities for future value creation.

The acquisition provides Sanofi with full rights to develop and commercialize INBRX-101 globally. The drug candidate is currently in a registrational Phase 2/3 trial evaluating its safety and efficacy in patients with AATD. Inhibrx believes INBRX-101 has multi-billion dollar peak sales potential if approved, which likely drove Sanofi’s interest in the asset.

Inhibrx’s innovative AAT therapy utilizes the company’s novel therapeutic protein engineering capabilities. INBRX-101 is designed to maintain the stability and activity of AAT, potentially enabling less frequent dosing than current AAT therapies. This next-generation approach could position INBRX-101 as a best-in-class treatment option for AATD.

The proposed transaction has been unanimously approved by the boards of directors of both companies and is expected to close in Q2 2024, subject to Inhibrx shareholder approval, regulatory clearances, and other customary closing conditions. Until then, it will be business as usual for Inhibrx as it continues developing its pipeline assets.

For Sanofi, the acquisition expands its portfolio in rare diseases while strengthening its capabilities in protein sciences and engineering. Adding INBRX-101 provides Sanofi with a promising late-stage candidate that can leverage its expertise and infrastructure in pulmonary diseases. Sanofi has been active on the deals front lately, including a recent $3.2 billion deal for Amunix Pharmaceuticals, as it refreshes its pipeline.

Meanwhile, the new Inhibrx Biosciences will emerge as an up-and-coming biotech with strong financial backing, a seasoned management team, and innovative technology platforms. The company will continue operating under the Inhibrx name and leadership. This strategic deal allows Inhibrx to unlock significant value from its lead program while retaining its other assets and resources to drive future growth.

The transaction is a win for both parties, providing Sanofi with a potential blockbuster drug and Inhibrx shareholders with an attractive return and ongoing upside through Inhibrx Biosciences. It demonstrates the broader trend of big pharma leveraging M&A to access innovative therapies from smaller biotech players. As Inhibrx’s programs advance, it will be interesting to see if Inhibrx Biosciences attracts buyout interest down the road. But for now, the company seems well-positioned to create value by advancing its earlier-stage pipeline.

Take a look at more emerging growth biotech companies by taking a look at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage universe.