Health Archives - Page 94 of 253

Release – Noble Capital Markets Initiates Equity Research Coverage on Xcel Brands, Inc.

Posted on November 1, 2023November 1, 2023 by [email protected]

November 1, 2023 at 8:30 AM EDT

NEW YORK, Nov. 01, 2023 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB) (“Xcel” or the “Company”), a media and consumer products company with significant expertise in livestream shopping and social commerce, is pleased to announce that Noble Capital Markets has initiated company-sponsored equity research coverage on the Company. The full report by Noble Capital Markets Senior Research Analyst Michael Kupinski and Research Analyst Patrick McCann, as well as news and advanced market data on Xcel Brands, Inc., is available on Channelchek.

About Xcel Brands

Xcel Brands, Inc. (NASDAQ: XELB) is a media and consumer products company engaged in the design, production, marketing, live streaming, social commerce and direct-to-consumer sales of branded apparel, footwear, accessories, fine jewelry, home goods and other consumer products, and the acquisition of dynamic consumer lifestyle brands. Xcel was founded in 2011 with a vision to reimagine shopping, entertainment, and social media as one thing. Xcel owns the Judith Ripka, Halston, LOGO by Lori Goldstein, and C. Wonder brands and a minority stake in the Isaac Mizrahi brand. It also owns and manages the Longaberger brand through its controlling interest in Longaberger Licensing LLC. Xcel is pioneering a true modern consumer products sales strategy which includes the promotion and sale of products under its brands through interactive television, digital live-stream shopping, social commerce, brick-and-mortar retail, and e-commerce channels to be everywhere its customers shop. The company’s brands have generated in excess of $4 billion in retail sales via livestreaming in interactive television and digital channels alone. Headquartered in New York City, Xcel Brands is led by an executive team with significant live streaming, production, merchandising, design, marketing, retailing, and licensing experience, and a proven track record of success in elevating branded consumer products companies. www.xcelbrands.com

About Noble Capital Markets

Noble Capital Markets, Inc. was incorporated in 1984 as a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving underfollowed small / microcap companies through investment banking, wealth management, trading & execution, and equity research activities. Over the past 37 years, Noble has raised billions of dollars for these companies and published more than 45,000 equity research reports. www.noblecapitalmarkets.com email: [email protected]

About Channelchek

Channelchek (.com) is a comprehensive investor-centric portal – featuring more than 6,000 emerging growth companies – that provides advanced market data, independent research, balanced news, video webcasts, exclusive c-suite interviews, and access to virtual road shows. The site is available to the public at every level without cost or obligation. Research on Channelchek is provided by Noble Capital Markets, Inc., an SEC / FINRA registered broker-dealer since 1984. www.channelchek.com email: [email protected]

For further information please contact:

Andrew Berger
SM Berger & Company, Inc.
216-464-6400
[email protected]

Source: Xcel Brands, Inc

Research – ZyVersa Therapeutics Announces Publication in Molecular Neurobiology Reinforcing Data Demonstrating That Inflammasome ASC Inhibitor IC 100 Attenuates the Inflammatory Response Causing Neuronal Damage in Multiple Sclerosis Model, Potentially Providing Neuroprotection

Posted on November 1, 2023November 1, 2023 by [email protected]

Research News and Market Data on ZVSA

Nov 1, 2023

PDF Version

Molecular Neurobiology publication demonstrated that NLRP3 inflammasomes have an important role in the pathogenesis of multiple sclerosis (“MS”) based on significant decreases in neuronal damage and demyelination resulting from NLRP3 inhibition in a mouse model of MS.
MS, which affects around 2.1 million people worldwide, is a chronic, progressive inflammatory disease of the central nervous system characterized by neuron damage in the brain and spinal cord, leading to significant physical and cognitive disability.
ZyVersa is developing Inflammasome ASC Inhibitor IC 100, designed to inhibit formation of multiple types of inflammasomes and their associated ASC specks to attenuate initiation and perpetuation of damaging inflammation.

WESTON, Fla., Nov. 01, 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 a publication in the peer-reviewed journal, Molecular Neurobiology, demonstrating neuroprotective effects of NLRP3 inflammasome inhibition in a mouse model of MS using a research tool molecule, MCC950.

In the paper titled, “Inhibiting the NLRP3 Inflammasome with MCC950 Alleviates Neurological Impairment in the Brain of EAE Mice,” the authors studied a mouse model which mirrors MS-like pathology and is commonly used to research MS disease progression. Key findings showed that NLRP3 inflammasome inhibition:

Ameliorated pathological changes in the spinal cord and neuron damage in the brain of MS mice.
Reduced microglia activation and prevention of its conversion to the M1 phenotype which induces neuroinflammation and neurotoxicity.
Reduced activation of astrocytes, which are involved in development of MS.

The authors concluded, “our work indicates that inhibition of NLRP3 inflammasome has the therapeutic effects of neuroprotection through immunomodulation and is a promising therapeutic strategy for MS.” To read the article, Click Here.

“There is a need for new therapeutic options for MS. Current drug therapies provide symptom control and help to alleviate disability, but they are not neuroprotective,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “It is encouraging that the research published in Molecular Neurobiology substantiates our published MS data with Inflammasome ASC Inhibitor IC 100, providing support for its use as a potential therapeutic option. By inhibiting ASC, IC 100 blocks formation of NLRP3 and other types of inflammasomes to block initiation of the inflammatory cascade. Likewise, IC 100 uniquely inhibits ASC specks to attenuate perpetuation of damaging inflammation”. To read the paper on IC 100 in an animal model of MS, 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
[email protected]
786-251-9641

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
[email protected]
646-577-8520

Dave Schemelia
[email protected]
609-468-9325

Release – Tonix Pharmaceuticals Announces Topline Results from Phase 2 Proof-of-Concept Study of TNX-601 ER for the Treatment of Major Depressive Disorder

Posted on November 1, 2023November 1, 2023 by [email protected]

Research News and Market Data on TNXP

October 31, 2023 5:00pm EDT

The study did not achieve statistical significance on the primary endpoint

Tonix is discontinuing development of TNX-601 ER based on the efficacy results of this study

Tonix expects topline data results in December 2023 for its Phase 2 study of TNX-1900 in chronic migraine and Phase 3 study of TNX-102 SL in fibromyalgia

CHATHAM, N.J., Oct. 31, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced topline results from the Phase 2 proof-of-concept double-blind, randomized, multi-center, placebo-controlled UPLIFT study of TNX-601 ER* (tianeptine hemioxalate extended-release tablets) in patients with major depressive disorder (MDD). The primary efficacy endpoint of change from baseline in depression severity, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, did not achieve clinical or statistical significance.

“Based on these efficacy results, we are discontinuing development of TNX-601 ER. We look forward to topline results from our Phase 2 study of TNX-1900 in chronic migraine in early December and topline results from our Phase 3 potential NDA-enabling study of TNX-102 SL in fibromyalgia in late December,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “We would like to thank the patients, their families, and all the investigators and researchers who participated in the Phase 2 UPLIFT study.”

In the Phase 2 UPLIFT study, TNX-601 ER was orally administered as monotherapy once a day to 132 patients who, upon entering the study, met a DSM-5 diagnosis of moderate-to-severe depression with a duration for the current major depressive episode of at least 12 weeks. Efficacy was assessed using the MADRS to measure any potential change in patients’ depression severity from baseline. In the study, TNX-601 ER was generally well-tolerated with a favorable safety profile. There was one serious adverse event (SAE) experienced in the placebo group, and two SAEs in the active treatment group deemed possibly related to study drug, both of which resolved without sequelae.

About the Phase 2 UPLIFT Study

The Phase 2 proof-of-concept UPLIFT study, TNX-TI-M201, is a double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-601 ER taken orally once-daily for 6 weeks for the treatment of moderate-to-severe MDD. It is a parallel design study with a TNX-601 ER 39.4 mg arm and a placebo arm. A total of 132 participants were randomized in a 1:1 ratio into the two arms across approximately 27 U.S. sites, enrolling adult patients 18-65 years old with a DSM-5 diagnosis of MDD and a duration for the current major depressive episode of at least 12 weeks. The primary efficacy endpoint is mean change from baseline in the MADRS total score at Week 6. Key secondary efficacy endpoints include the Clinical Global Impression – Severity Scale (CGI-S) and the Sheehan Disability Scale (SDS).

For more information, see ClinicalTrials.gov Identifier: NCT05686408.

About Major Depressive Disorder (Depression)

According to the National Institute of Mental Health, an estimated 21 million adults in the U.S. in 2020 experienced at least one major depressive episode¹, with highest prevalence among individuals aged 18-25 at a rate of 17.0%. For approximately 2.5 million adults in the U.S., adjunctive therapies are necessary for depression treatment.^2,3 Depression is a condition characterized by symptoms such as a depressed mood or loss of interest or pleasure in daily activities most of the time for two weeks or more, accompanied by appetite changes, sleep disturbances, motor restlessness or retardation, loss of energy, feelings of worthlessness or excessive guilt, poor concentration, and suicidal thoughts and behaviors. These symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The majority of people who suffer from depression do not respond adequately to initial antidepressant therapy.⁴

¹ Data Courtesy of SAMHSA on Past Year Prevalence of Major Depressive Episode Among U.S. Adults 2020. Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml

² IMS NSP, NPA, NDTI MAT-24-month data through Aug 2017.

³ Kubitz N, et al. PLoS One 2013, 8 (10), e76882.

⁴ Rush AJ, et al. Am J. Psychiatry 2007, 163 (11), 1905-1917.

About TNX-601 ER

TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a novel oral formulation of tianeptine designed for once-daily daytime dosing in development as a candidate for the treatment of MDD. Tianeptine sodium (amorphous) immediate release (dosed 3 times daily) was first marketed for depression in France in 1989 and has been available for decades in Europe, Russia, Asia, and Latin America for the treatment of depression. Tianeptine sodium has an established safety profile from decades of use in these jurisdictions. Currently no tianeptine-containing product is approved in the U.S. and no extended-release tianeptine product is approved in any jurisdiction. Tonix discovered a novel oxalate salt of tianeptine that may provide improved stability, consistency, and manufacturability compared to known salt forms of tianeptine.

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 enrollment of a potentially confirmatory Phase 3 study in the third 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 . 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
[email protected]
(862) 904-8182

Peter Vozzo
ICR Westwicke
[email protected]
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
[email protected]
443-213-0495

MustGrow Biologics Corp. (MGROF) – TerraSante Receives USDA Organic Approval

Posted on November 1, 2023November 1, 2023 by [email protected]

Wednesday, November 01, 2023

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Receiving Approval. MustGrow announced yesterday that the Company has been awarded an organic compliance certification from the USDA National Organic Program for its TerraSante crop fertilizer and soil amendment technology. The product is now OMRI Listed in the following Generic Material Listings: NOP: Plant Extracts, Class: Crop Fertilizers and Soil Amendments.

A Potential Boon to US Farmers. The Organic Materials Review Institute’s (OMRI) organic certification can potentially provide an opportunity for farmers to reduce synthetic chemical and fertilizer use while meeting growing market demand for organic biological products. It involves a strict review of product ingredient composition and observance of manufacturing compliance standards required in organic production in which, upon final registration of product approval from U.S. state agencies, TerraSante will be marketed with “OMRI listed for organic use”.

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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.

Cocrystal Pharma (COCP) – Phase 2a Influenza Trial Receives Authorization To Begin

Posted on November 1, 2023November 1, 2023 by [email protected]

Wednesday, November 01, 2023

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), hepatitis C viruses and noroviruses. 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.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Phase 2a Trial Expected To Begin In The UK Before Year-End. Cocrystal announced that it has received authorization from the United Kingdom’s Medicines Health and Regulatory Agency to begin its Phase 2a clinical trial. This Phase 2a trial will be conducted in the UK and test CC42344 in seasonal and pandemic influenza. The trial is expected to begin before the end of 2023 with results expected around mid-2024.

Study Was Designed To Test Hunan Volunteers In A Controlled Setting. The study will be a single-center, placebo-controlled study designed to challenge healthy human volunteers with influenza A. Subjects will receive pharmaceutically-produced influenza A virus on the first day. This will be followed 24 hours later by either CC-42344 or placebo once daily for 5 days. Endpoints in the trial are changes in viral load, symptoms, and biomarkers, as well as safety and tolerability.

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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

ZyVersa Data Boosts Promise of Inflammasome Inhibitor for MS Treatment

Posted on November 1, 2023November 1, 2023 by [email protected]

Clinical stage biopharmaceutical company ZyVersa Therapeutics (NASDAQ: ZVSA) announced compelling new research this week supporting the potential of its drug candidate IC 100 to treat multiple sclerosis (MS). Publication of the preclinical data on IC 100’s neuroprotective effects provided an upbeat development for ZyVersa’s stock and boosted confidence in its inflammasome inhibition technology.

ZyVersa is developing first-in-class therapies for inflammatory and kidney diseases. The company’s pipeline is led by IC 100, an antibody designed to inhibit inflammasome overactivation and reduce pathogenic inflammation. The recent research published in Molecular Neurobiology demonstrated that IC 100 reduced neuronal damage, microglial activation, and demyelination in a mouse model of MS.

MS is an inflammatory disease where the immune system attacks the central nervous system, degrading myelin and eventually causing nerve damage and disability. An estimated 2.8 million people globally suffer from MS, representing a major unmet medical need. Current MS drugs only slow progression of the disease.

ZyVersa believes IC 100’s unique mechanism inhibiting the ASC component of multiple inflammasome types can provide neuroprotection and block inflammation underlying development and progression of MS. The new data provides critical validation of this thesis, according to experts in the field.

ZyVersa’s stock jumped 12% on the news, reflecting increased investor enthusiasm for the company’s inflammasome targeting technology. The data comes right before ZyVersa anticipated beginning Phase 2 testing of IC 100 in MS patients during the first half of 2024.

The MS preclinical results support the potential of ZyVersa’s approach and represent an important step forward. However, some industry observers caution it remains to be seen whether the neuroprotective effects fully translate from animals to humans. But these are viewed as very promising early stage findings.

Beyond MS, ZyVersa believes IC 100 may help treat a range of other neuroinflammatory conditions characterized by overactive inflammasomes such as Alzheimer’s and Parkinson’s disease. The new research helps derisk the company’s pipeline and technology platform.

In the wake of the positive data, ZyVersa appears well positioned to ride the wave of growing interest in leveraging inflammation research to develop better therapies for neurological diseases. While still an early stage company, ZyVersa stock offers an intriguing investment opportunity based on the promise of its science and immunotherapy pipeline. Expectations will be high for the biotech to execute on its MS program and fully tap into the potential of its ASC inhibition technology.

Release – GeoVax to Report Third Quarter 2023 Financial Results and Provide Corporate Update on November 8, 2023

Posted on October 31, 2023October 31, 2023 by [email protected]

Research News and Market Data on GOVX

GeoVax to Host Conference Call at 4:30 PM ET

Atlanta, GA, October 31, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it will report third quarter 2023 financial results on Wednesday, November 8, 2023, after the close of U.S. markets. Following the release, management will host a live conference call and webcast, including Q&A, at 4:30 p.m. ET to provide a corporate update and discuss financial results.

Dial-in numbers:

Domestic: 800-715-9871

International: 646-307-1963

Conference ID: 7519986

Webcast:

A webcast of the live call may be accessed here and on the Events page of the GeoVax website.

A webcast replay of the call will be available for three months via the same link as the live webcast approximately two hours after the end of the call.

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:
[email protected]	[email protected]	[email protected]
678-384-7220	212-698-8699	202-779-0929

Release – Cocrystal Pharma Receives UK MHRA Authorization to Initiate Its Phase 2a Influenza Human Challenge Trial with Oral PB2 Inhibitor CC-42344

Posted on October 31, 2023October 31, 2023 by [email protected]

Research News and Market Data on COCP

OCTOBER 31, 2023

BOTHELL, Wash., Oct. 31, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) announces receipt of authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a Phase 2a human challenge trial with its broad-spectrum, oral PB2 inhibitor CC-42344 as a potential treatment for pandemic and seasonal influenza A. Cocrystal expects to begin treating influenza-infected subjects in this trial during the fourth quarter of 2023.

In late 2022 Cocrystal reported highly favorable safety and tolerability results in the single-ascending and multiple-ascending dose portions of the healthy volunteer Phase 1 trial conducted in Australia. The Phase 2a single-site, double-blind, placebo-controlled human challenge trial will evaluate the safety, viral and clinical measurements of orally administered CC-42344 in subjects infected with influenza A.

“We are pleased to have met the regulatory requirements of the MHRA to begin this Phase 2a human challenge trial in the UK,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “Influenza is a major global health threat that may become more challenging to treat due to emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. The need for new therapeutic and prophylactic treatments is clear. Our encouraging Phase 1 data demonstrated that CC-42344 has a favorable safety profile and is well-tolerated. CC-42344 has the potential to be a best-in-class antiviral treatment for pandemic and seasonal influenza infections.”

“We are closely working with a world leading clinical research organization that is experienced in testing infectious and respiratory disease antivirals using human challenge clinical trials,” said James Martin, Cocrystal’s CFO and Co-CEO. “Receiving authorization to move ahead with our Phase 2a trial is a major step in our quest to bring CC-42344 to market and make a meaningful contribution to improving health and reducing the cost of care.”

About Seasonal Influenza
Each year there are approximately one 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. In addition to the health risk, influenza is responsible for approximately $10.4 billion in direct costs for hospitalizations and outpatient visits for adults in the U.S. annually.

About CC-42344
CC-42344 was discovered using Cocrystal’s proprietary structure-based drug discovery platform technology and is a novel approach to treating pandemic and seasonal influenza A. In vitro data show that CC-42344 is highly active against drug-resistant influenza A strains with a high barrier to resistance, while also demonstrating favorable pharmacokinetic and safety profiles.

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), hepatitis C viruses and noroviruses. 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 initiation and characteristics of a Phase 2a study for CC-42344 and the potential efficacy and clinical benefits of such product candidate and the demand for such a product. 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, the risks arising from manufacturing and research delays arising labor shortages and other factors, the ability of our Clinical Research Organization partner to recruit volunteers for, and to proceed with, the Phase 2a clinical study for CC-42344, general risks arising from conducting a clinical trial, receipt of regulatory approvals for future trials, regulatory changes, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the governmental authorities, and potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we may develop. 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
[email protected]

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
[email protected]

# # #

Source: Cocrystal Pharma, Inc.

Released October 31, 2023

Release – MustGrow Receives USDA Organic Approval for Biological Fertilizer and Soil Amendment Technology

Posted on October 31, 2023October 31, 2023 by [email protected]

Research News and Market Data on MGROF

USDA National Organic Program (OMRI Listed^®) has awarded MustGrow’s TerraSante^TM Crop Fertilizer and Soil Amendment technology with organic compliance.
TerraSante^TM is a mustard plant-based technolgy focused on soil and soil microbiome health, nutrient and water use efficiencies, and plant yields.
MustGrow plans to continue to advance its TerraSante^TM registration approval process in key U.S. states.

SASKATOON, Saskatchewan, Canada, October 31, 2023 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow”) is pleased to announce receipt of organic compliance certification from the USDA National Organic Program for its TerraSante^TM crop fertilizer and soil amendment technology. TerraSante^TM is now OMRI Listed^® in the following Generic Material Listing(s): NOP: Plant Extracts, Class: Crop Fertilizers and Soil Amendments.

The organic certification from Organic Materials Review Institute (“OMRI”) (www.omri.org) may provide an opportunity for farmers to reduce synthetic chemical and fertilizer use while meeting growing market demand for organic biological products. The OMRI approval process includes a strict review of product ingredient composition and observance of manufacturing compliance standards required in organic production. Pending final registration of product approval from U.S. state agencies, TerraSante^TM will be marketed with the legend “OMRI listed for organic use”.

“We believe that organic compliance is a major milestone towards commercializing TerraSante^TM” commented MustGrow’s COO, Colin Bletsky. “Agriculture needs new organic innovations to support food production and this organic certification further supports our belief that MustGrow’s technologies could be impactful. The key U.S. agricultural regions are under constant pressure to eliminate or reduce synthetic products, so natural, OMRI certified technologies, like TerraSante^TM, have great promise for commercial-scale adoption.”

MustGrow believes this soil amendment and biofertility initiative will complement its existing biocontrol programs in preplant soil fumigation, postharvest food preservation, and bioherbicide, which are currently under development with four global partners: Janssen PMP, Bayer, Sumitomo Corporation, and NexusBioAg. These four partnered programs continue to achieve performance milestones and expand globally in scope and investment.

TerraSante^TM for Soil and Ecological Health

MustGrow’s soil amendment and biofertility development programs will focus on soil and soil microbiome health, nutrient and water use efficiencies, and plant yields. Initially, the development work is anticipated to progress in Washington, Idaho, Oregon, California and Arizona, before expanding nationwide across the United States.

Soil is a farmer’s most valuable and precious asset, and MustGrow’s plant-based technologies are being developed with the intention to improve not only the health of the soil, but also the surrounding ecological environment.

As a soil amendment in mixable form, TerraSante^TM contains nutritious plant proteins and carbohydrates that feed soil microbes, potentionally improving beneficial microbial activity and ensuring long-term sustainable soil health. These targeted micro-communities have been shown to work to improve nutrient availability, which can potentially increase plant vigor and yields, while reducing plant stress. TerraSante^TM has the potential to improve crop nutrient uptake and, hence, overall crop performance. There are no artificial additives or preservatives used during its manufacturing.

MustGrow expects to initially pursue TerraSante^TM branded registrations in North America for soil amendment applications, followed by formulations and brands targeting the biofertility markets. The soil amendment and biofertility products will utilize multiple technologies derived from novel plant-based extracts from mustard and potentially other sources.

Soil Amendment and Biofertility Marketplace

The global fertilizer market is anticipated to reach US$242 billion by 2030, up from US$193 billion in 2021 (2.5% CAGR).⁽¹⁾ This aggregate fertilizer figure includes the following sub-markets, which MustGrow intends to target initially with TerraSante^TM and potentially other branded products:

Soil amendment: estimated market size in 2022 was US$3.5 billion and is expected to be US$8.0 billion by 2030 (11.0% CAGR).⁽²⁾
Biofertility: estimated market size in 2021 was US$2.7 billion and is estimated to be US$7.0 billion by 2030 (12.3% CAGR).⁽³⁾

Combined, these additional market segments have the potential to add over US$15 billion of target market opportunity globally for MustGrow by 2030, which is almost double from the initially targeted infield biocontrol market.⁽¹⁾

Alternatives to Synthetic Fertilizers are Needed

With the world’s population expanding, agriculture production and global food security are increasingly important. Fertilizers continue to play a critical role in agriculture, yet plans to reduce their use have been amplified in recent years to minimize the negative consequences of climate change through emission reduction strategies. Canada, for example, has set a voluntary national fertilizer emissions reduction target of 30% below 2020 levels by 2030 to lower greenhouse gas emissions.⁽²⁾ Sustainable, climate-friendly solutions may play a role in helping to offset this reduction while balancing the nation’s economic health. For example, Canada’s fertilizer industry directly and indirectly supports over 76,000 jobs and contributes nearly C$13 billion to Canadian GDP.⁽²⁾

The European Green Deal is targeting a 20% reduction in fertilizer use by 2030, while also ensuring no deterioration in soil fertility, as part of the European Commission’s aim to reduce nutrient losses by at least 50% by 2030.⁽³⁾ Fertilizer reduction is a key element of the broader Green Deal target of a minimum 55% net reduction in greenhouse gas emissions by 2030.⁽⁴⁾

Soil amendment and biofertifility innovations, such as MustGrow’s TerraSante^TM technology, could provide a key agricultural solution to the combined effects of fertilizer reduction targets alongside the need to increase farm production, farm profitability, economic growth and global food security.

Source:
1. Statista, Fortune Business, Polaris Market Research.
2. https://fertilizercanada.ca/our-focus/stewardship/emissions-reduction-initiative/
3. https://agriculture.ec.europa.eu/system/files/2022-02/factsheet-farmtofork-comparison-table_en_0.pdf
4. https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/european-green-deal_en

———

About MustGrow

MustGrow is an agriculture biotech company developing organic biocontrol, soil amendment and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world. MustGrow and its leading global partners — Janssen PMP (pharmaceutical division of Johnson & Johnson), Bayer, Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions to potentially replace harmful synthetic chemicals. Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its technology in the soil amendment and biofertily markets. Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements. Pending regulatory approval, MustGrow’s patented liquid technologies could be applied through injection, standard drip or spray equipment, improving functionality and performance features. Now a platform technology, MustGrow and its global partners are pursuing applications in several different industries from preplant soil treatment and weed control, to postharvest disease control and food preservation, to soil amendment and biofertility. MustGrow has approximately 50.1 million basic common shares issued and outstanding and 55.0 million shares fully diluted. For further details, please visit www.mustgrow.ca.

Contact Information

Corey Giasson
Director & CEO
Phone: +1-306-668-2652
[email protected]

MustGrow Forward-Looking Statements

Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: its plans to continue to advance its TerraSante^TM registration approval process in key U.S. states; the opportunity that being OMRI listed for organic use may provide to farmers to reduce synthetic chemical fertilizer use while meeting growing market demand for organic biological products; the potential outcome of pending final registration product approvals; the planned marketing of TerraSante^TM with the legend, “OMRI listed for organic use”; the relevance of organic compliance towards commercializing TerraSante^TM; MustGrow’s belief that TerraSante^TM will complement its existing biocontrol programs; the expected focus of MustGrow’s soil amendment and biofertility development programs on soil and soil microbiome health, nutrient and water use efficiencies, and plant yields; the anticipated progression of MustGrow’s development work in Washington, Idaho, Oregon, California and Arizona, before expanding nationwide across the United States; MustGrow’s expectation that it will initially pursue TerraSante^TM branded registrations in North America for soil amendment applications, followed by formulations and brands targeting the biofertility markets; and the opportunity that soil amendment and biofertility innovations, such as MustGrow’s TerraSante^TM technology, could provide a key agricultural solution to the combined effects of fertilizer reduction targets alongside the need to increase farm production, farm profitability, economic growth and global food security.

Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include market receptivity to investor relations activities as well as those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2022 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.

Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

GeoVax Labs, Inc. (GOVX) – Clinical Trial Expansion Continues With A Stream Of Milestones

Posted on October 31, 2023October 31, 2023 by [email protected]

Tuesday, October 31, 2023

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.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Site Expansion Should Increase Rate Of Enrollment. GeoVax announced the additional of new clinical sites in the Phase 2 trial for CM04S1, its COVID-19 vaccine to protect patients who are immunocompromised due to treatment for hematological malignancies. Patients who receive treatments including allogenic/autologous stem cell transplant or CAR-T therapy have difficulty responding to the available COVID-19 vaccines, leaving them vulnerable.

Site Expansion Should Increase Speed of Enrollment. The trial is designed to compare the safety and immunogenicity of CM04S1 directly against the mRNA vaccines from Pfizer and Moderna. The trial began at the City of Hope Medical center in California and will begin treating patients at Wake Forest Baptist Medical Center (North Carolina), University of Massachusetts Medical Center, and Fred Hutchinson Cancer Research (Washington). Patient enrollment at these sites should increase the enrollment rate and number of patients in the study, providing greater statistical significance with shortened time to results.

Get the Full Report

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

Weight Loss Drugs Shake Up Pharma Stocks, But Wider Impact Remains Unclear

Posted on October 31, 2023October 31, 2023 by [email protected]

A new class of potent weight loss drugs has been shaking up the pharmaceutical sector, sending stocks of some major drug makers soaring. But the wider impact on other industries like food, retail, and medical devices remains uncertain amidst changing consumer behaviors.

Novo Nordisk and Eli Lilly have been riding high thanks to their injectable diabetes medications Ozempic and Mounjaro. Though only approved for diabetes, both drugs have shown dramatic weight loss potential in clinical trials.

Ozempic and Mounjaro belong to a drug class called GLP-1 agonists. They mimic a hormone that regulates appetite and food intake. Patients using the new drugs at high doses can lose up to a quarter of their body weight.

Predictions have emerged that these drugs could reshape industries from restaurants to airlines. But so far, the actual impact beyond pharma has been muted.

In the stock market, Novo Nordisk shares are up over 50% in the last year thanks to Ozempic. The drug’s sales hit $5.2 billion in the first 9 months of 2022. Mounjaro brought in $187 million for Lilly within just 2 months of its launch.

“The physiological benefits these treatments offer patients help address significant unmet needs,” said Josh Schimmer, senior analyst at Evercore ISI.

The market potential also has investors excited. If just 2% of obese Americans eventually use weight loss medications, it could swell into a $58 billion market according to Evercore forecasts.

Among other drug stocks involved, Amgen owns a portion of Mounjaro’s revenue due to a licensing deal with Lilly. Meanwhile, companies like Entera Bio and Novo Nordisk have oral pills in late stage testing that could expand the weight loss drug market substantially.

However, analysts caution growth depends on how insurers cover the drugs which can cost nearly $1,500 a month without insurance. Usage also remains low currently at around just 1% of the US population.

Beyond pharma, the impact is hazier. The consumer staples sector has been the worst performing segment of the S&P 500 this year as investors brace for potential fallout.

But so far, food and beverage leaders seem unfazed. PepsiCo, Hershey, and Constellation Brands recently reported strong quarters without seeing signs of slowing demand.

Retailers and restaurants have opportunities to adapt their offerings to court health-focused consumers. “Maybe the GLP-1 consumer looks very different three or five years from now,” said Goldman Sachs analyst Jason English.

Surprisingly, medical device makers also haven’t seen slowed growth yet either. In fact, continuous glucose monitoring usage grew right alongside Ozempic prescriptions, suggesting weight loss isn’t eliminating diabetes demand.

However, bariatric surgery has been slightly impacted according to comments from Johnson & Johnson’s CEO. Other discretionary categories like apparel and travel could eventually be impacted if behaviors change long term.

For now, the uncertainty leaves analysts split on whether these drugs are a fad or the beginning of a healthcare revolution. But Wall Street is clearly enamored with the weight loss leaders.

As more data emerges on usage and impact, it will determine whether stock declines are overdone for consumer staples beyond pharma. If wide adoption materializes, Novo and Lilly appear poised to dominate a blockbuster new drug market.

Breaking Boundaries: Lilly’s Investment in Base Editing for Heart Disease

Posted on October 31, 2023November 1, 2023 by [email protected]

Pharmaceutical giant Eli Lilly is expanding its efforts in cardiovascular disease research through a new deal with Beam Therapeutics and Verve Therapeutics worth up to $600 million. The deal centers around base editing, an emerging gene editing technology that Beam and Verve are pioneering for new precision genetic medicines.

Under the agreement announced today, Lilly will acquire Beam’s opt-in rights to co-develop and co-commercialize several of Verve’s base editing programs targeting cardiovascular disease. This includes lead programs focused on PCSK9 and ANGPTL3 – two high profile genes involved in cholesterol regulation and metabolism. A third undisclosed target related to liver-mediated cardiovascular disease is also included.

In exchange, Beam will receive a hefty $200 million upfront payment along with a $50 million equity investment from Lilly. Beam is further eligible for up to $350 million in future milestone payments as the programs advance through clinical trials and regulatory approvals.

For Lilly, this deal provides access to a promising new approach to treating cardiovascular disease, an area where the company already has a major presence. Lilly has been a leader in cholesterol drugs like statins for decades, and more recently entered the PCSK9 market through its ownership of Repatha. But despite effective medications, cardiovascular disease remains a top killer globally.

Base editing offers a way to precisely and permanently modify disease-causing genes in order to lower cholesterol and potentially deliver stronger treatment effects than current options. Early human trials have already shown base editing of PCSK9 can lower LDL cholesterol. Verve recently initiated a clinical trial using base editors to target both PCSK9 and ANGPTL3 simultaneously.

Take a moment to take a look at Ocugen (OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines.

As a technology pioneer, Beam is widely considered the leader in base editing. The company has uncovered a series of natural enzymes that can be programmed to make single letter DNA changes at targeted sites without cutting the double strand like traditional CRISPR gene editing. This opens possibilities for more precise control while minimizing unintended effects.

Beam CEO John Evans highlighted base editing as a core strategic priority, and views creative partnerships as a key path to accelerate development. “Our initial collaboration with Verve and this new transaction with Lilly are exemplary of our execution of that strategy,” Evans said. “This deal provides meaningful upfront capital to advance our portfolio of clinical- and research-stage programs, with significant additional value achievable as the Verve programs advance.”

For Beam, the capital influx provides fuel to advance its broader base editing pipeline including programs in sickle cell disease, alpha-1 antitrypsin deficiency, and glycine encephalopathy. The company now expects its cash runway to extend into the second half of 2026.

Lilly’s history with Verve also preceded this acquisition. In 2021, Lilly led Verve’s $105 million Series B financing and took a stake in the company. That marked another early mover deal to tap into base editing. Verve CEO Sekar Kathiresan said “Lilly’s extensive capabilities in drug development and commercialization make them an ideal partner for Verve as we work together to advance base editing programs aimed at reducing CVD risk through genome editing.”

Beam and Verve join a short list of biotechs focused on realizing the promise of base editing. But Lilly’s involvement marks a huge vote of confidence from the pharma world. As base editing advances toward the clinic, deals like this suggest major players view the technology as more than just hype.

Lilly has been aggressively scouting the latest biotech innovations through both in-house R&D and external deals. The past year saw Lilly acquire hot companies like POINT Biopharma and Repare Therapeutics for large sums. Base editing adds a new tool in Lilly’s toolkit for next generation therapeutic approaches.

Cardiovascular disease also represents an attractive area for investment despite already having effective medications. Heart attacks, strokes and other complications remain a top cause of mortality globally. In the US alone, 1 in 4 deaths are attributable to heart disease each year. Even modest improvements in treatment can translate into major public health benefits.

The risk for Lilly and other major pharmaceutical companies is that base editing and gene editing fail to live up to their early promise in the clinic. However, most experts are optimistic the technology will usher in a new wave of therapies over the next decade. For a pharma giant like Lilly with over $28 billion in yearly revenue, the potential reward is well worth the investment risk to stay on the cutting edge.

Release – GeoVax Commences Site Expansion for Phase 2 Trial of Next-Generation COVID-19 Vaccine

Posted on October 30, 2023October 30, 2023 by [email protected]

Research News and Market Data on GOVX

Last updated: 30 October 2023 13:48
Created: 30 October 2023 12:02
Hits: 28

Designed to Protect Immunocompromised Patients Against Severe COVID-19

ATLANTA, GA, October 30, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it has commenced the planned site expansion for the Phase 2 clinical trial investigating its next-generation SARS-CoV-2 vaccine, GEO-CM04S1, as a primary vaccine in immunocompromised patients. In addition to study enrollments completed at the City of Hope Medical Center (Duarte, California), the trial will be initiating enrollment of eligible patients at Wake Forest Baptist Medical Center (Winston Salem, North Carolina), the University of Massachusetts Medical Center (Worcester, Massachusetts), and Fred Hutchinson Cancer Research Center (Seattle, Washington).

The Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024) is evaluating the safety and immunogenicity of GEO-CM04S1, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, in patients with hematologic malignancies who have received either an allogeneic hematopoietic stem cell transplant, an autologous hematopoietic stem cell transplant or chimeric antigen receptor (CAR) T cell therapy. Such patients often have difficulty mounting an adequate protective antibody response after receiving currently available COVID-19 vaccines.

David Dodd, GeoVax Chairman and CEO, commented, “We are pleased with these site activations to expand the scope and reach of this trial, which we expect will accelerate patient enrollment for this important study in one of the highest at-risk patient populations, currently underserved by available vaccines. We believe the unique properties of GEO-CM04S1 potentially offer a more robust, durable degree of protection than the current authorized COVID-19 vaccines, not only as a vaccine for highly vulnerable immunocompromised patients for whom the currently authorized mRNA vaccines may be inadequate, but also potentially for healthy patients as a universal booster vaccine to the mRNA vaccines. In the U.S., there are approximately 15 million individuals who, as a result of their compromised immune systems, often do not adequately respond to the current authorized vaccines. Worldwide, there are an estimated 240+ million such patients. Our hope is that GEO-CM04S1 provides robust, durable immune protection for such patients, while also providing a critically important alternative to COVID-19 booster vaccines for healthy individuals.”

A recent publication in Vaccines (https://doi.org/10.3390/vaccines11091492) from the open-label portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses against ancestral as well as recently evolved SARS-CoV-2 virus strains. These data support the progression of the Phase 2 clinical study, which includes a direct comparison to currently approved mRNA vaccines.

About GEO-CM04S1

GEO-CM04S1 is based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating.

In addition to this ongoing study, GEO-CM04S1 is being evaluated in two other Phase 2 clinical trials:

As a booster vaccine for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. gov Identifier: NCT04639466. GeoVax recently announced that this trial has fully enrolled.
As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.

About GeoVax

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:
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678-384-7220	212-698-8699	202-779-0929