Category: Health

Release – Tonix Pharmaceuticals to Present at The National Academies Committee on the Current State of Research, Development, and Stockpiling of Smallpox Medical Countermeasures Public Meeting

Posted on by cpatches
Research News and Market Data on TNXP

CHATHAM, N.J., Dec. 11, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Seth Lederman M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at the National Academies of Sciences, Engineering, and Medicine Committee on the Current State of Research, Development, and Stockpiling of Smallpox Medical Countermeasures public meeting on Thursday, December 14, 2023 via Zoom. Dr. Lederman will participate in a panel discussion on Vaccine Research & Development taking place from 2:00 – 2:45 p.m. ET.

Discussions will explore lessons learned from the recent COVID-19 pandemic and mpox multi-country outbreak to inform an evaluation of the current state of research, development, and stockpiling of smallpox readiness and response measures.

A webcast of the meeting can be found here and will be available under the IR Events tab of the Tonix website at www.tonixpharma.com following the presentation.

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 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 development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed the clinical phase of a potentially confirmatory Phase 3 study in the fourth quarter of 2023, with topline data expected in late December 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results were reported in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin) is in development as a preventive treatment in chronic migraine, with analysis of topline data from a Phase 2 proof-of-concept study expected to be completed late December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. 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 fourth quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. 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’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. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. 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
(919) 360-3039

Cigna and Humana Merger Unravels Amid Price Disputes, Cigna to Pursue Share Buyback

Posted on by cpatches

Cigna has reportedly withdrawn from a significant merger with Humana, citing failed negotiations on pricing as the primary reason, according to insider sources. The deal, if successful, would have propelled the combined entity’s value beyond $140 billion, positioning it as a major player in the insurance sector. The potential mega-deal would have undoubtedly faced scrutiny from regulators, especially in light of regulatory blocks on similar consolidations in the health insurance sector six years ago. Cigna, undeterred by the merger setback, has announced plans to repurchase $10 billion worth of shares, a move deemed by management as a value-enhancing use of capital given their belief that Cigna shares are currently undervalued.

Connecticut-based Cigna, whose shares rose 12.1% to $290.07 in premarket trading on Monday, is down approximately 22% this year, experiencing a 10% decline since late November when reports of the deal talks with Humana surfaced. The company remains open to the prospect of a future merger with Humana, asserting confidence in the deal’s regulatory feasibility despite the Biden administration’s stringent stance on mergers.

Both Cigna and Humana are significant players in the health insurance sector, each with distinct operations. Cigna, a global health service company, has a diversified portfolio covering insurance, pharmacy benefits, behavioral health, and related services. The company’s strategic decision to explore the sale of its Medicare Advantage business, which caters to government health insurance for individuals aged 65 and older, indicates ongoing efforts to refine its business focus.

On the other hand, Humana, a prominent health and well-being company, specializes in health insurance and wellness solutions. The potential merger with Cigna would have endowed the combined entity with increased scale, positioning it as a formidable competitor against larger U.S. health insurance players such as UnitedHealth Group and CVS Health.

As Cigna navigates the aftermath of the abandoned merger, the company’s shift towards share buybacks and potential bolt-on acquisitions aligning with its strategies reflects a strategic realignment. The health insurance landscape remains dynamic, and Cigna’s future moves, including a possible revisiting of a Humana combination, will undoubtedly shape the trajectory of both companies in this ever-evolving sector.

Get to know a selection of emerging growth biotechs by exploring Noble Capital Markets’ Senior Analyst Robert LeBoyer’s coverage list.

Pushing the Frontiers: Innovation and Investment in Organ Transplantation

Posted on by slightbourne@noblecapitalmarkets.com

The NobleCon19 panel discussion moderated by Nathan Cali, investment banker at Noble Capital Markets, on organ transplantation featured prominent figures in the field, including Dr. Karin Hehenberger, an organ transplant patient and founder of Lyfebulb, Dr. David Alexandre Gros, CEO of Eledon Pharmaceuticals, Dr. Muhammed Mohiuddin, director of the cardiac xenotransplantation program at the University of Maryland, and Dr. Pietr Witoski, surgery director of pancreatic and islet tranplant program at the University of Chicago. The discussion delved into their experiences, challenges in the organ transplant landscape, and revolutionary advancements, especially focusing on the concept of xenotransplantation.

Organ transplantation has come a remarkably long way since the first successful procedures in the 1950s and 60s. Yet there remain significant unmet needs and opportunities to further improve patient outcomes, quality of life, and access to these lifesaving procedures. At a presentation during NobleCon19, a panel of experts explored some of the latest breakthroughs and remaining challenges in areas ranging from immunosuppression to cross-species transplantation.

A Complex Treatment Paradigm

As patient-turned-advocate Dr. Karin Hehenberger related from personal experience, undergoing an organ transplant and living with a graft is filled with difficulties. The trauma of the surgery itself and needing immune-suppressing drugs just to avoid rejection deliver blows to physical health and mental wellbeing. This begins with a harrowing wait for a matching donor organ, continues through post-operative complications like infections, and extends for the rest of one’s life.

The panelists agreed the pressure on patients could be significantly reduced through innovation. More targeted immunosuppressants without harmful side effects would greatly improve quality of life after transplant surgery. Some emerging drug candidates like Eledon Pharmaceuticals Tegoprubart show early signs of progress on this front. There is also a global shortage of donor organs trailing far behind demand; new sources through xenotransplantation or regenerative medicine techniques could help resolve this shortage.

“We need a community where transplanted patients can come together, generate data, and advocate for change,” urged Dr. Hehenberger.

The valuable role of patient communities mirrors the interdisciplinary cooperation needed among the surgeons, specialists, social workers, and other caregivers that make organ transplantation successful. As Dr. Hehhenberger explained, the assessment process for transplant eligibility spans physical health, mental fitness, medication compliance, accessible transportation, and financial support. It is complex care with little margin for error.

An Evolving Market Landscape

Currently, the organ transplant market racks up over $5 billion in value each year and continues expanding at a steady pace. Much of this activity centers specifically around kidney transplants, where surgical innovations and public policy initiatives keep pushing the boundaries. As Dr. DA Gros noted, there are now a quarter million Americans living with a functioning kidney graft – proof of concept for an underappreciated treatment paradigm.

And yet, the surface has barely been scratched in terms of serving potential patients. Over half a million more remain tethered to dialysis as a stand-in for natural kidney function, with 125,000 added to this group annually in the U.S. alone. Dialysis generates its own burdens: decreased workplace productivity, infection risks, lower quality of life. From both humanitarian and financial viewpoints, empowering wider transition from dialysis to transplantation promises tremendous upside.

Experts on the panel targeted improved education around organ transplant options as a key opportunity. Many patients lack full information about the benefits transplant procedures can offer, or they confront social stigmas against this route. Policy revisions to widen access and increase support for lower-income patient communities could have an outsized impact as well.

Meanwhile, the business of organ transplantation continuously evolves. Major pharma companies like Bristol Meyers Squib remain heavily invested, yet a series of smaller players also drive momentum through novel immuno-therapy products. Audience members were encouraged to track firms like Aelix and Tacus for the next wave of clinical updates that will shape standard of care.

Pioneering the Future

Homing in on the future, speakers keyed in on barriers still to be conquered in transplantation medicine. While kidney procedures serve as a beachhead, there is a pressing need to expand reliable methods across more organ types while lengthening graft duration at the same time. This is no small task.

It will require rethinking conventional assumptions for a field that has relied predominantly on broad immune suppression since its inception. Some emerging biotech pipelines target specific T and B cell pathways implicated in chronic organ rejection, attempting to avoid toxicity associated with generalized immunosuppression. Early data hints at improved longevity for liver and heart grafts, but longer studies are still needed.

An even more radical solution highlighted by multiple panelists is the concept of xenotransplantation: introducing organs from other species like pigs into human patients. Recent demonstrations of human-pig heart and skin grafts saw patients survive months post-procedure compared to an anticipated span of days or weeks. The results electrified the transplant community given implications for essentially eliminating organ supply constraints.

That said, experts admit there are hurdles left to address before clinical adoption. Ethical quandaries exist around genetically modifying donor animals and infectious disease transmission risks from one species to another. Questions also persist about which immune pathways necessitate targeting for prolonged graft survival and how to refine the anti-rejection pharmaceutical regimens employed.

Signs point to countries with more flexible regulatory regimes as the likely springboards for refining xenotransplant methods and technology in the shorter-term. Yet the longer-term promise seems resoundingly clear. “If allowed, we will solve the organ shortage problem,” declared surgeon Dr. Peter Witoski when asked about outlook for the field.

A Call to Action

In closing the panel presentation, speakers underscored a sense of guarded optimism balanced with persistent unmet needs in transplantation medicine today. Limitations around donor organ supply and chronic graft failure continue exacting a real human toll, even if raw statistics showcase a steady rise in life-saving procedures overall.

It will take coordinated effort from policy makers, researchers, clinicians, investors and patient advocates to push new discoveries over the finish line – where they can impact the maximum number of lives. Key questions around optimal business models for novel therapeutics, data transparency, and equitable access are unlikely to solve themselves.

Yet the convergence of breakthrough technologies and innovative platforms for generating evidence, educating stakeholders and disseminating insights points toward a sea change for what the future may hold in this vital area of healthcare. The experts and audience members left the discussion around organ transplantation feeling energized to play their respective parts in driving that change.

Watch the webcast from The Organ Transplant presentation at NobleCon19 here

Release – ZyVersa Therapeutics Announces Publication Demonstrating That Plasma Levels of NLRP3 Inflammasomes Correlate with Progression of Diabetic Kidney Disease in Patients with Type 2 Diabetes

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Dec 7, 2023

  • Diabetic kidney disease (DKD), which affects around 240 million people with Type 2 diabetes worldwide, is the leading cause of end-stage renal disease, which requires dialysis or kidney transplant for survival.
  • The article published in Alternative Therapies demonstrates that plasma NLRP3 inflammasomes and their resulting proinflammatory cytokines are significantly elevated in early-stage DKD and that levels progressively increase as kidney function worsens, with highly significant elevations (p<0.01) at each stage of disease.
  • Data suggest that early DKD intervention with inflammasome inhibitors has potential to attenuate disease progression.
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which inhibits multiple inflammasome pathways (including the inflammasome NLRP3 pathway) to attenuate initiation and perpetuation of damaging inflammation that is pathogenic in DKD and other inflammatory diseases.

WESTON, Fla., Dec. 07, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of renal and inflammatory diseases, announces publication of an article in the peer-reviewed journal, Alternative Therapies, demonstrating that plasma NLRP3 inflammasomes and their resulting proinflammatory cytokines are significantly elevated in early-stage DKD and that levels progressively increase as kidney function worsens.

In the paper titled, “Correlation Between Plasma NLRP3, IL-1β, and IL-18 and Diabetic Nephropathy in Patients With Type 2 Diabetes,” the authors evaluated the plasma of 152 patients with type 2 diabetes and DKD stratified by stage of disease (stages 1-5) and 30 patients with type 2 diabetes without kidney disease who serve as controls. Following are key findings reported in the paper:

  • Plasma levels of NLRP3 and proinflammatory cytokines, IL-1β, and IL-18, were significantly higher than controls in patients in each of the 5 stages of DKD, with progressively higher levels as kidney disease progressed (p<0.01).
  • NLRP3, IL-1β, and IL-18 levels positively correlated with DKD stage (p= 0.01), based on the Spearman correlation analysis.
  • These data are consistent with other studies demonstrating that inflammation has an important role in the development and progression of DKD.

To read the article, Click Here.

“The research published in Alternative Therapies reinforces the role of inflammasome-driven inflammation in development and progression of DKD, the leading cause of end-stage kidney disease, which requires dialysis or kidney transplant for survival,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “Although substantial progress has been made in slowing progression of DKD with introduction of ACE inhibitors, ARBs, and most recently SGLT2 inhibitors, patients are still progressing to end-stage renal disease. The data published in Alternative Therapies suggest that early DKD intervention with inflammasome inhibitors has potential to help attenuate disease progression.”

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 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. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

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.

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

AbbVie’s $8.7 Billion Acquisition of Cerevel Therapeutics: A Game-Changer for Neuroscience Innovations

Posted on by slightbourne@noblecapitalmarkets.com

Pharmaceutical giant AbbVie made a huge splash in the neuroscience space this week with the announcement of its definitive agreement to acquire clinical-stage biotech Cerevel Therapeutics for $8.7 billion. This transforms AbbVie’s position in neuroscience and adds multiple late-stage assets to its pipeline that could drive significant growth over the next decade.

At $45 per share in cash, AbbVie is paying a hefty premium for Cerevel, reflecting its belief in the blockbuster potential of the company’s pipeline. Cerevel has built an impressive roster of new compounds for psychiatric and neurological conditions—areas where AbbVie already has an established presence with treatments for Parkinson’s disease and migraine but now gains even more scale.

The crown jewel of the deal is emraclidine, an investigational antipsychotic for schizophrenia and other psychiatric disorders that could set a new standard of care. Currently in late-stage development, emraclidine has shown early signs of superior efficacy and safety compared to existing schizophrenia meds. With schizophrenia impacting over 5 million people across developed markets, emraclidine represents a multibillion-dollar opportunity for AbbVie commercially.

Beyond emraclidine, Cerevel has a range of other clinical-stage neuro assets that strengthen and complement AbbVie’s pipeline. These include tavapadon for Parkinson’s, CVL-354 for depression, and darigabat for epilepsy—all of which have potential for best-in-class status in their respective categories.

Take a moment to take a look at Noble Capital Capital Market’s Senior Research Analyst Robert LeBoyer’s coverage universe.

According to AbbVie’s chairman and CEO Richard Gonzalez, “Our existing neuroscience portfolio and our combined pipeline with Cerevel represents a significant growth opportunity well into the next decade.” He notes AbbVie’s global commercial infrastructure can help accelerate these drugs to market globally.

Gonzalez has orchestrated a highly successful strategy for AbbVie centered around building global therapeutic franchises in immunology, oncology, and aesthetics. Adding neuroscience as a fourth core franchise has been an ambition for awhile. Between Humira facing biosimilar competition and the need to fuel AbbVie’s next chapter of growth, this acquisition is a strategic step to position neuroscience as a more prominent piece of the puzzle.

For Cerevel, the buyout represents a major win and validation of the platform they have built. As CEO Dr. Ron Renaud comments, “Cerevel has always been committed to transforming what is possible in neuroscience…with AbbVie’s long-standing expertise in developing and commercializing medicines on a global scale, Cerevel’s novel therapies will be well positioned to reach more people.”

Wall Street is reacting positively to the deal announcement, with shares of both companies rising 3-4% the day it was announced. Investors recognize the growth implications and are cheering AbbVie’s move to recharge its pipeline.

While the deal is expected to close in 2024 pending approvals, it marks the continuation of a surge in biotech M&A driven by the appetite of large pharmas to augment their portfolios externally. With over 200 neuroscience programs in mid- to late-stage industrywide across CNS disorders, neurological treatments are having a moment right now. For AbbVie, the Cerevel transaction cements its intent to be at the forefront in capturing this opportunity.

Release – ZyVersa Therapeutics, Inc. Announces Pricing of $5.0 Million Public Offering

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVA

Dec 6, 2023

WESTON, Fla., Dec. 06, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa” or “the Company”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases with high unmet needs, announced today the pricing of a “reasonable best efforts” public offering of 4,000,000 shares of common stock (or pre-funded warrants in lieu thereof) and accompanying Series A and Series B warrants to purchase up to an aggregate of 8,000,000 shares of common stock at a combined public offering price of $1.25, resulting in gross proceeds of approximately $5.0 million. The Series A Warrants to purchase up to an aggregate of 4,000,000 shares of common stock and Series B Warrants to purchase up to an aggregate of 4,000,000 shares of common stock will have an exercise price of $1.25 per share, will be exercisable immediately following the date of issuance and will expire five years and eighteen months from the original issuance date, respectively.

The closing of the offering is expected to occur on or about December 11, 2023, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds of this offering for working capital and other general corporate purposes.

A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-275320) previously filed with the Securities and Exchange Commission (SEC) which became effective on December 6, 2023. The offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. An electronic copy of the final prospectus will be filed with the SEC and may be obtained, when available, on the SEC’s website located at http://www.sec.gov and may also be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at prospectus@allianceg.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About ZyVersa Therapeutics

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 market and other conditions, ZyVersa’s ability to satisfy all conditions precedent to the closing of the offering; 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 – ZyVersa Therapeutics Announces Publication Showing AIM2 and NLRP3 Inflammasomes Promote Atherosclerosis in Diabetes, Supporting IC 100’s Rationale for Targeting ASC to Inhibit Multiple Inflammasome Pathways

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Dec 6, 2023

  • Atherosclerosis, an inflammatory disease characterized by buildup of cholesterol, lipids, and other substances (plaque) in arteries leading to heart attack and stroke, is accelerated in patients with diabetes.
  • The study published in Diabetes demonstrates that AIM2 and NLRP3 inflammasome activation leads to development of atherosclerotic lesions in diabetic mice.
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which inhibits multiple inflammasome pathways (including NLRP3 and AIM2) to attenuate initiation and perpetuation of damaging inflammation that is pathogenic in numerous diseases.

WESTON, Fla., Dec. 06, 2023 (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, announces publication of an article in the peer-reviewed journal, Diabetes, demonstrating that AIM2 and NLRP3 inflammasome activation contributes to development of atherosclerosis in two different animal models of type 1 diabetes.

In the paper titled, “Hematopoietic NLRP3 and AIM2 inflammasomes promote diabetes-accelerated atherosclerosis, but increased necrosis is independent of pyroptosis,” the authors studied mouse models of type 1 diabetes and atherosclerosis. Following are key findings reported in the paper:

  • Diabetic animals demonstrated activation of inflammasome pathways, based on increased levels of plasma IL-1β and IL-18, and elevated levels of cleaved caspase- 1 in the peritoneal cavity fluid.
  • Each of the two different type 1 diabetes models exhibited similar levels of plasma IL- 1β and IL-18 and similar aortic lesion sizes and severity.
  • Diabetic mice deficient in NLRP3 and/or AIM2 had reduced aortic lesion size compared to diabetic controls, indicating that NLRP3 and AIM2 inflammasome activation contributes to atherosclerotic lesion development.
  • Results are consistent with other animal model studies showing deficiencies in essential inflammasome components, such as NLRP3, AIM2, ASC, and caspase-1, appear to protect against atherosclerosis.

To read the article, Click Here.

“The research published in Diabetes reinforces that inhibition of multiple types of inflammasomes, not just NLRP3, may be required to effectively control inflammation in diseases, such as atherosclerosis, in which activation of more than one type of inflammasome is pathogenic,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “ZyVersa’s Inflammasome ASC inhibitor IC 100 is designed to inhibit formation of multiple types of inflammasomes and their associated ASC specks to attenuate initiation and perpetuation of damaging inflammation contributing to numerous diseases.” To review a white paper summarizing the mechanism of action and preclinical data for IC 100, 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 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.

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 – Tonix Pharmaceuticals Announces IND Clearance by the FDA for Phase 2 Trial of TNX-2900 for the Treatment of Prader-Willi Syndrome, the Most Common Genetic Cause of Life-Threatening Childhood Obesity

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

December 04, 2023 7:00am ESTDownload as PDF

TNX-2900 is a proprietary magnesium-potentiated formulation of intranasal oxytocin, a naturally occurring hormone that reduces appetite and eating

Preclinical data show magnesium-potentiation increases the potency of exogenous oxytocin

Formulations of intranasal oxytocin without magnesium have reported inconsistent results in clinical trials of Prader Willi Syndrome1,2

CHATHAM, N.J., Dec. 04, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support clinical development of TNX-2900 (intranasal potentiated oxytocin), a proprietary magnesium (Mg2+)-enhanced formulation of intranasal oxytocin, to treat Prader-Willi syndrome (PWS) in children and adolescents. TNX-2900 for the treatment of PWS was granted Orphan Drug designation by the FDA in 2022.

The Phase 2 study approved by the IND is a dose-finding study involving approximately 36 PWS patients divided into four groups with approximately nine PWS patients per group. One group will receive placebo and three groups will receive different dosage regimens of TNX-2900. Tonix intends to seek a partner to advance TNX-2900 for PWS in clinical development.

“We are pleased that TNX-2900 is cleared for clinical studies for the treatment of PWS in children and adolescents as there remains a significant need for new therapies, particularly for PWS hyperphagia, which currently has no approved treatments,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “PWS is the most common genetic cause of life-threatening childhood obesity.3,4 We believe adding Mg2+ to the formulation has the potential to improve intranasal oxytocin’s therapeutic action.”

The IND application for TNX-2900 was supported by preclinical data demonstrating that Mg2+ enhances the potency of oxytocin. Oxytocin is a naturally-occurring hormone that reduces appetite and eating and regulates hunger, anxiety and prosocial behavior. PWS is a genetic disorder associated with abnormalities of the oxytocin system5. Several previous clinical studies in PWS of intranasal oxytocin without Mg2+-potentiation have shown trends toward improvement, but the results have been inconsistent.1,2 Tonix believes that Mg2+-potentiation of intranasal oxytocin in PWS may improve consistency in clinical trials because in animal studies Mg2+-potentiation appears to eliminate the high-dose suppression of oxytocin’s inverted “U”-shaped dose response.6

Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals added, “Recent reports show Mg2+ is necessary for oxytocin to fully activate the oxytocin receptor.3,6 Oxytocin has potent effects in adult mice correcting behavioral characteristics of the Magel2 knock-out mouse model for PWS and autism.4 Oxytocin has many potential therapeutic roles in reducing appetite, eating, weight, migraine pain and autistic spectrum behaviors. Tonix recently completed enrollment in a Phase 2 study of TNX-1900, a related Mg2+-potentiated intranasal oxytocin candidate, for the prevention of migraine headaches, and is also studying TNX-1900 through external collaborations for the treatment of obesity in adolescents, binge eating disorder, bone health in autism, and social anxiety disorder.”

About Prader-Willi Syndrome (PWS)
PWS is recognized as the most common genetic cause of life-threatening childhood obesity and affects males and females with equal frequency and all races and ethnicities. PWS results from the absence of expression of a group of genes on the paternally acquired chromosome 15. The hallmarks of PWS are lack of suckling in newborns and, in children and adolescents, severe hyperphagia, an overriding physiological drive to eat, leading to severe obesity and other complications associated with significant mortality. A systematic review of the morbidity and mortality as a consequence of hyperphagia in PWS found that the average age of death in PWS was 22.1 years.7 There is no approved medication to treat poor feeding in newborns or hyperphagia in children and adolescents with PWS. Given these serious or life-threatening manifestations of these conditions, there is a critical need for effective treatments to decrease morbidity and mortality, improve quality of life, and increase life expectancy in people with PWS. Oxytocin has potent effects in adult mice correcting behavioral characteristics of the Magel2 knock-out mouse model for PWS and autism.4 In addition, oxytocin has potent effects in correcting behavioral characteristics of the neonatal Magel2 knock-out mouse model for PWS and autism8 and intriguing effects in a clinical trial of neonates with PWS.9

About TNX-2900 and Tonix’s Potentiated Oxytocin Platform
TNX-2900 is based on Tonix’s patented intranasal potentiated oxytocin formulation intended for use by adults and adolescents. Tonix’s patented potentiated oxytocin formulation is believed to increase specificity for oxytocin receptors relative to vasopressin receptors as well as to enhance the potency of oxytocin. Tonix is also developing a different intranasal formulation, designated TNX-1900, for prophylaxis of chronic migraine as well as for adolescent obesity, binge eating disorder, bone health in autism and social anxiety disorder. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. Oxytocin is believed to be more than 600 million years old and is present in vertebrates including mammals, birds, reptiles, amphibians and fish.10,11 It was originally approved by the U.S. Food and Drug Administration as Pitocin®*, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor. An intranasal formulation of oxytocin is marketed in some European countries to assist in the production of breast milk as Syntocinon®** (oxytocin nasal 40 units/ml). *Pitocin® is a trademark of Par Pharmaceutical, Inc.

**Syntocinon® is a trademark of BGP Products Operations GmbH

Citations

  1. Shalma NM, et al. Diabetes Metab Syndr. 2023. 17(2):102711.
  2. Rice LJ, et al. Curr Opin Psychiatry. 2018. 31(2):123-127.
  3. Meyerowitz JG, et al. Nat Struct Mol Biol. 2022. 29(3):274-281.
  4. Meziane H, et al. Biol Psychiatry. 2015. 78(2):85-94.
  5. Correa-da-Silva F, et al. J Neuroendocrinol. 2021. 33(7):e12994.
  6. Bharadwaj VN, et al. Pharmaceutics. 2022. 14(5):1105.
  7. Bellis SA, et al. Eur J Med Genet. 2022. 65(1):104379.
  8. Bertoni A, et al. Mol Psychiatry. 2021. 26(12):7582-7595.
  9. Tauber M, et al. Pediatrics. 2017. 139(2):e20162976.
  10. Oxytocin in Wikipedia https://en.wikipedia.org/wiki/Oxytocin (accessed 8-8-23)
  11. Gruber CW. Exp Physiol. 2014. 99(1):55-61. doi: 10.1113/expphysiol.2013.072561.

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 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 development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed the clinical phase of a potentially confirmatory Phase 3 study in the fourth quarter of 2023, with topline data expected in late December 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results were reported in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment in chronic migraine, and enrollment has completed in a Phase 2 proof-of-concept study with topline data expected in early December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. 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 fourth quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. 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’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. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. 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

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released December 4, 2023

Pfizer Weight Loss Pill Hits Snag in Mid-Stage Trial

Posted on by slightbourne@noblecapitalmarkets.com

Pharmaceutical giant Pfizer suffered a setback this week in the high-stakes race to tap into the burgeoning multi-billion dollar weight loss drug market. The company announced it is halting development of the twice-daily formulation of its experimental obesity pill danuglipron after underwhelming mid-stage trial results.

While the drug induced significant weight loss in obese patients, it came at the cost of poor tolerability. Over half of participants dropped out of the phase 2 study due to adverse gastrointestinal side effects like nausea and diarrhea.

Nonetheless, Pfizer still intends to stay in the game with a once-daily version of danuglipron. The company aims to release fresh phase 2 data on the more competitive formulation in early 2024 before determining next steps.

For a drugmaker grappling with fading Covid-19 revenues, the news deals a tough blow to its strategy to offset declines through potential new blockbusters for obesity. Just last year, CEO Albert Bourla tagged the total addressable weight loss market at a whopping $90 billion.

But competition is cutthroat, with Novo Nordisk and Eli Lilly vying to convert millions from their injectable diabetes meds to an oral option. Their rival pills have already posted mid-teens percentage weight loss results that position them to potentially leapfrog Pfizer’s attempt.

Danuglipron Quick Facts

  • Twice-daily formulation now discontinued after 6.9% to 11.7% weight loss at 32 weeks
  • Well below 14-15% loss seen as competitive threshold
  • High rates of nausea, vomiting, diarrhea
  • Over 50% dropout rate

Key Takeaways for Investors
The disappointing data for danuglipron’s twice-daily pill underscores several investor concerns around Pfizer’s efforts to expand into weight loss medicines.

Uphill Battle Against Rivals
Novo Nordisk and Eli Lilly already dominate the obesity drug landscape with their injectable products Saxenda and Ozempic. Lilly’s oral candidate tirzepatide is showing roughly 15% weight loss over 72 weeks, clearing the competitive bar Pfizer failed to hit.

While the field is large enough for multiple winners, Pfizer faces substantial share challenges from these deeply entrenched rivals. Its best-case outcome may be carving off a small slice rather than market leadership.

Tolerability Issues Limiting
Danuglipron has now faltered twice in mid-stage studies due to side effects leading over half of volunteers to quit treatment. The once-daily route shows some promise, but gastrointestinal problems may hamper uptake if they persist. By comparison, tirzepatide posted a 21% dropout rate.

Uncertainty Remains High
With phase 3 trials still a distant prospect, the program faces a long road ahead fraught with risk. While danuglipron evinced significant weight-loss efficacy, real-world commercial success depends greatly on improving its poor tolerability profile.

Until then, uncertainty around Pfizer’s weight loss aspirations stays high. Expect sales projections to remain muted absent positive late-stage outcomes down the line. But rivals like Lilly and Novo aren’t standing still either, making danuglipron’s path ahead even trickier.

Release – ZyVersa Therapeutics, Inc. Announces Reverse Stock Split and Increase in Authorized Shares of Common Stock

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Nov 30, 2023

PDF Version

WESTON, Fla., Nov. 30, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa” or the “Company”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of renal and inflammatory diseases with high unmet needs, announces that its board of directors has approved a 1-for-35 reverse stock split of the Company’s common stock. The board of directors has also approved an increase in the Company’s authorized shares of capital stock. The Company’s stockholders approved the reverse stock split and the increase in authorized capital stock at the Company’s Annual Meeting of Stockholders held on October 31, 2023. The stockholders granted the board of directors the authority to determine the exact split ratio and when to proceed with the reverse stock split.

The reverse stock split will become effective on December 4, 2023 at 4:01 pm, Eastern Time, (“Effective Time”) and the Company’s common stock is expected to begin trading on a reverse stock split-adjusted basis on The Nasdaq Global Market (“Nasdaq”) on December 5, 2023 at market open under the existing ticker symbol, “ZVSA.” The reverse stock split is intended to increase the price per share of the Company’s common stock to allow the Company to demonstrate compliance with the $1.00 minimum bid price requirement for continued listing on Nasdaq, among other benefits.

As of the Effective Time, every 35 shares of the Company’s issued and outstanding common stock will be combined into one share of common stock. The par value per share of our common stock will remain unchanged at $0.0001. Proportional adjustments will be made to the number of shares of common stock issuable upon the exercise of the Company’s equity awards, convertible securities and warrants, as well as the applicable exercise price, and the number of shares authorized and reserved for issuance pursuant to the Company’s equity incentive plans.

No fractional shares will be issued as a result of the reverse stock split; rather, the Company will issue an additional fraction of a share of common stock to round the number of shares to the nearest whole share, so no stockholder will hold fractional shares following the reverse stock split.

The Company’s transfer agent, Continental Stock & Trust Company, will serve as the exchange agent for the reverse stock split. Registered stockholders holding pre-reverse stock split shares of common stock electronically in book-entry form are not required to take any action to receive post-reverse stock split shares. Those stockholders who hold their shares in brokerage accounts or in “street name” will have their positions automatically adjusted to reflect the reverse stock split, subject to each broker’s particular processes, and will not be required to take any action in connection with the reverse stock split.

Likewise, effective November 30, 2023, the Company amended its certificate of incorporation to increase the authorized number of shares of the Company’s capital stock from 111,000,000 to 251,000,000 and the number of authorized shares of common stock from 110,000,000 to 250,000,000.

Additional information about the reverse stock split and increase in authorized capital stock can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on September 13, 2023, a copy of which is available at www.sec.gov.

About ZyVersa Therapeutics

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 the effect that the reverse stock split may have on the price of ZyVersa’s common stock and ZyVersa’s ability to maintain its listing on The Nasdaq Global Market.

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.

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 – Eledon Pharmaceuticals to Present at Noble Capital Markets’ Emerging Growth Equity Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

November 29, 2023

PDF Version

IRVINE, Calif., Nov. 29, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that David-Alexandre C. Gros, M.D., Chief Executive Officer, will present a company overview at the upcoming NobleCon19 – Noble Capital Markets’ 19th Annual Emerging Growth Equity Conference on Monday, December 4, 2023, at 12:00 p.m. EST. Dr. Gros will also participate in a panel discussion titled: The Organ Transplant Revolution, that will take place on Monday, December 4, 2023, at 5:00 p.m. EST. The NobleCon19 conference will take place December 3-5, 2023, in Boca Raton, Florida.

A video webcast of the company overview presentation will be available the following day on the Company’s website at https://ir.eledon.com/news-and-events/events, and as part of a complete catalog of presentations available at Noble Capital Markets’ Conference website: www.nobleconference.com and on Channelchek: www.channelchek.com, the investor portal created by Noble. The webcast will be archived on Eledon’s website, the NobleCon website, and on Channelchek.com for 90 days following the event.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target within the costimulatory CD40/CD40L cellular pathway. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Release – GeoVax to Participate in Upcoming December Investor Events

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

  • Last updated: 29 November 2023 14:00
  • Created: 29 November 2023 13:48
  • Hits: 6

Atlanta, GA, November 29, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that its senior management will participate in two upcoming investor events:

NobleCon19, December 3-5, 2023, Boca Raton, FL

Date/Time:                    December 4, 2023 at 10:00 a.m. ET

Presentation Topic:     Corporate Overview and Update

Speaker:                        David Dodd, Chairman & CEO

Noble Capital Markets’ Nineteenth Annual Emerging Growth Equity Conference will be held at Florida Atlantic University, Executive Education Complex, in Boca Raton, FL.  There will be an opportunity to meet GeoVax’s management during a breakout session scheduled immediately following the Company’s presentation.

A video webcast of the presentation will be available the following day on GeoVax’s website (www.geovax.com) and as part of a complete catalog of presentations available at Noble Capital Markets’ Conference website (www.nobleconference.com) and on Channelchek (www.channelchek.com) the investor portal created by Noble. The webcast will be archived for 90 days on each platform following the event. 

Emerging Growth Conference, December 6-7, 2023, Virtual

Date/Time:                    December 6, 2023 at 3:25 p.m. ET

Presentation Topic:     Update on Next-Generation COVID-19 Vaccine Program

Speaker:                        David Dodd, Chairman & CEO

For more information and to register to attend the GeoVax presentation, please visit Emerging Growth Conference.

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.

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 – Cocrystal Pharma Highlights its Novel Inhaled and Oral Influenza A Antiviral CC-42344 at the World Vaccine Congress West Coast

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

NOVEMBER 29, 2023

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BOTHELL, Wash., Nov. 29, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), announces the presentation of favorable data demonstrating activity of its potent broad-spectrum PB2 inhibitor CC-42344 against pandemic and seasonal influenza A strains at the World Vaccine Congress West Coast. Cocrystal has initiated a Phase 2a human challenge trial with oral CC-42344 in the UK in subjects infected with influenza A, and plans to begin a Phase 1 trial with inhaled CC-42344 as a potential influenza A treatment and prophylaxis in Australia in the first half of 2024.

In his presentation, “Taking a new route: Development of novel inhaled and oral influenza antiviral, CC-42344,” Cocrystal President and co-CEO Sam Lee, PhD discussed the potential prevention and therapy of influenza infection using inhaled CC-42344. Dr. Lee commented that CC-42344 exhibits superior antiviral activity compared with oseltamivir (Tamiflu®) and demonstrates a novel mechanism of action with high barrier of resistance. He noted that Cocrystal discovered and developed CC-42344 utilizing the Company’s proprietary structure-based drug discovery platform technology, which is proving successful in delivering multiple broad-spectrum antiviral leads for influenza and other viral diseases.

“We are excited to accomplish another important milestone with the influenza antiviral CC-42344. Based on our recent preclinical data, CC-42344 exhibits superior lung exposure, a favorable safety profile, and efficacy in influenza-infected human lung epithelia. We also demonstrated highly efficient delivery of inhaled CC-42344 into the lung,” he said. “Inhaled CC-42344 could be developed for both therapeutic and prophylactic influenza treatment. We are encouraged by this potential breakthrough influenza treatment option.”

Slides from the presentation are available on the Company’s website.

About CC-42344
CC-42344 is specifically designed to be effective against all significant pandemic and seasonal influenza A strains and to have a high barrier to resistance due to the way the virus’ replication machinery is targeted. CC-42344 targets the influenza polymerase, an essential replication enzyme with several highly essential regions common to multiple influenza strains. In vitro testing showed CC-42344’s excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to certain approved influenza antivirals, while also demonstrating favorable pharmacokinetic and safety profiles.

About Seasonal Influenza
Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths, according to the World Health Organization. On average about 8% of the U.S. population contracts influenza each season. Influenza is responsible for approximately $10.4 billion in direct costs for hospitalizations and outpatient visits for adults in the U.S. annually.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2) noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s ongoing Phase 2a human challenge trial for CC-42344 as a product candidate for oral treatment of influenza A, and the planned initiation of a Phase 1 clinical trial in the first half of 2024 for CC-42344 as a product candidate for inhaled treatment of influenza A, and the potential efficacy and clinical benefits of, and market for, such product candidate. The words “believe,” “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. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to our ability to proceed with the Phase 2a and Phase 1 studies referred to above including recruiting volunteers for and procuring or manufacturing materials for such studies by our clinical research organizations and vendors, and the results of such studies. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. 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.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

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Source: Cocrystal Pharma, Inc.

Released November 29, 2023