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Release – Eledon Reports Updated Data from Ongoing Phase 1b Trial Evaluating Tegoprubart for Prevention of Rejection in Kidney Transplantation

Posted on November 2, 2023November 2, 2023 by [email protected]

November 2, 2023

Data from 11 participants demonstrates tegoprubart successfully prevented kidney transplant rejection and was generally safe and well-tolerated

Aggregate mean eGFR was above 70 mL/min/1.73m2 at all reported time points after day 90 supporting tegoprubart’s potential to protect organ function in patients undergoing kidney transplantation

Eledon will host a conference call today at 5:00 p.m. ET

IRVINE, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today reported results from the Company’s ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of rejection in patients undergoing de novo kidney transplantation. Results were presented at the American Society of Nephrology Kidney Week 2023 Annual Meeting taking place in Philadelphia, PA from November 2-5, 2023.

“We are excited to present updated safety and efficacy results from our ongoing Phase 1b trial which continue to support the potential of tegoprubart as a novel kidney transplant immunosuppressive therapy to prevent rejection and better preserve organ function without many of the side effects associated with tacrolimus, the current standard of care,” said David-Alexandre C. Gros, M.D., Chief Executive Officer. “We remain committed to the transplant community who are in urgent need of better treatment options, and we look forward to continuing this study in parallel with our Phase 2 BESTOW study initiated earlier this year.”

At the time of data submission, results from the 11 participants in the Phase 1b trial demonstrated that tegoprubart is generally safe and well-tolerated in patients undergoing kidney transplantation. There have been no cases of hyperglycemia, new onset diabetes, tremor, or cytomegalovirus infection commonly seen with tacrolimus. One participant experienced a mild T cell mediated rejection (Banff score 1a) on day 99. This patient was treated for the rejection and remains in the study. There were no cases of graft loss or death.

Aggregate mean estimated glomerular filtration rate (eGFR) – a measure of kidney function – was above 70 mL/min/1.73m² at all reported time points after day 90. Historical studies have reported average eGFRs generally in the low 50 mL/min/1.73m² range during the first year after kidney transplant using standard of care. One participant has completed the study with an eGFR of 91 at one year (day 374) and is now enrolled in a Phase 2 open-label extension (OLE) study, which will evaluate the long-term safety, pharmacokinetics, and efficacy of tegoprubart in participants who have completed one year of treatment in either the ongoing Phase 1b or Phase 2 BESTOW study.

“In this Phase 1b trial, patients treated with tegoprubart demonstrated robust improvements in eGFR with a strong safety profile,” said Dr. John S. Gill, MD, Professor of Medicine at the University of British Columbia, St. Paul’s Hospital, Vancouver, Canada, and Principal Investigator of the study. “These results further support the promise of CD40L costimulatory blockade in organ transplantation. I look forward to additional readouts from this study in 2024.”

The Phase 1b open-label study has enrolled 11 participants who underwent kidney transplantation in Canada, Australia, and the United Kingdom. Each participant received rabbit antithymocyte globulin (ATG) induction and a maintenance regimen consisting of tegoprubart, mycophenolate mofetil, and corticosteroids. The primary endpoint of the study is safety. Other endpoints include characterizing the pharmacokinetic profile of tegoprubart, the incidence of biopsy proven rejection, and eGFR.

In September, Eledon announced that the first participant had been dosed in the Company’s Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. The multicenter, two-arm, active comparator clinical study is enrolling approximately 120 participants undergoing kidney transplantation in the United States and other countries to evaluate the safety, pharmacokinetics, and efficacy of tegoprubart compared to the calcineurin inhibitor tacrolimus. The BESTOW trial’s primary endpoint is designed to test the potential superiority of tegoprubart vs. tacrolimus in post kidney transplant kidney function at 12 months as measured by eGFR. The Company expects to complete enrollment at the end of 2024.

Full details on the poster presentations are below:

Title: Tegoprubart for the prevention of rejection in kidney transplant: update of emerging data from an ongoing trial
Presenter: Steve Perrin, Ph.D., President and Chief Scientific Officer, Eledon Pharmaceuticals
Poster Number: TH-PO835
Session Title: Transplantation: Clinical – I [PO2102-1]
Session Date and Time: November 2, 2023 from 10:00 AM to 12:00 PM EDT

Following the presentation, a copy of the poster will be available on the Investor section of the Company’s website at https://ir.eledon.com/news-and-events/publications-and-presentations.

Conference Call

Eledon will hold a conference call today, November 2, 2023 at 5:00 p.m. Eastern Time to discuss the updated trial results. The dial-in numbers are 1-888-886-7786 for domestic callers and 1-416-764-8658 for international callers. The conference ID is 66816567. A live webcast of the conference call will be available on the Investor Relations section of the Company’s website at www.eledon.com. The webcast will be archived on the website following the completion of the call.

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

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

Release – Tonix Pharmaceuticals’ Vaccine Candidate, TNX-1800, Selected by NIH/NIAID Project NextGen for Inclusion in Clinical Trials

Posted on November 2, 2023November 2, 2023 by [email protected]

Research News and Market Data on TNXP

November 02, 2023 8:00am EDTDownload as PDF

NIAID is conducting early phase clinical trials on select next generation COVID-19 vaccine candidates with the intent to identify promising vaccine candidates

TNX-1800, a live virus percutaneous vaccine candidate, is based on Tonix’s recombinant pox virus (RPV) platform

Phase 1 clinical trial of TNX-1800 expected to start in the second half of 2024

NIAID will cover the full cost of the clinical trial; Tonix will supply the vaccine candidate

CHATHAM, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), will conduct a Phase 1 clinical trial with TNX-1800 (recombinant horsepox virus, live vaccine),¹ Tonix Pharmaceuticals’ vaccine candidate to protect against COVID-19.

Tonix is developing a novel vaccine platform initially targeting COVID-19, smallpox and mpox (monkeypox). The intent is to provide durable protection against severe disease and prevent forward transmission, primarily by eliciting a T-cell immune response. TNX-1800 expresses the spike protein of SARS-CoV-2, was immunogenic, well tolerated² and showed promise in protecting animals from challenge with SARS-CoV-2 delivered directly into the lungs.³ A related horsepox-based vaccine, TNX-801¹, protected animals against challenge with monkeypox virus delivered directly into the lungs.⁴ TNX-801 is also the vector on which TNX-1800 is based and has been shown to be >1,000-fold more attenuated than modern vaccinia virus vaccine (VACV) strains in immunocompromised mice.⁵ The Phase 1 trial of TNX-1800 is expected to start in the second half of 2024. NIAID will study TNX-1800 by percutaneous administration.

“We believe our novel vaccine platform technology has the potential to provide durable protection from respiratory pathogens and slow their spread,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-1800 will be the first vaccine candidate using our live virus recombinant pox virus (RPV) platform technology to enter clinical trials. We hope to expand the portfolio of RPV-based vaccines to address several other known respiratory threats including smallpox, mpox and tuberculosis. We are committed to supporting NIAID in assembling a variety of vaccine platform options to ensure the availability of effective vaccines in the face of known and emerging threats. We look forward to participating in the Project NextGen initiative.”

“Project NextGen,” is an initiative by the U.S. Department of Health and Human Services (HHS) to advance a pipeline of new, innovative vaccines and therapeutics for COVID-19. NIAID will be conducting clinical trials to evaluate several early-stage vaccine candidates. The Phase 1 study involving TNX-1800 is designed to assess safety and immunogenicity in approximately 60 healthy adult volunteers. Upon completion of the trial, NIAID and Tonix Pharmaceuticals will assess the results and determine the next steps for the development of TNX-1800.

NIAID will cover the full cost of the clinical trial, including operations and related analysis. Tonix will be responsible for providing clinical trial materials, and upon completion will have the right to rely on the findings in regulatory filings with the U.S. Food and Drug Administration (FDA) to support the approval of its COVID-19 vaccine and other vaccines based on the RPV platform.

About Project NextGen

Project NextGen is a $5 billion initiative to develop the next generation of vaccines and therapeutics to combat COVID-19. Based at the HHS and led by the Administration for Strategic Preparedness and Response’s Biomedical Advanced Research and Development Authority and the NIH’s NIAID, Project NextGen will coordinate across the federal government and the private sector to advance the pipeline of new, innovative vaccines and therapeutics into clinical trials and potential review by the U.S. Food and Drug Administration (FDA) for authorization or approval, and commercial availability for the American people. The program will focus on several areas, including mucosal vaccines, vaccines that provide broader protection against variants of concern and a longer duration of protection, pan-coronavirus vaccines, and new and more durable monoclonal antibodies.

About TNX-1800*
TNX-1800 (recombinant horsepox virus) is a live virus vaccine for percutaneous administration that is designed to express the spike protein of the SARS-CoV-2 virus and to elicit a predominant T cell response. The RPV platform is based on a horsepox vector, which is a live replicating, attenuated virus that has been shown to be >1,000-fold more attenuated than modern VACV strains in immunocompromised mice.⁵ Horsepox and the vaccinia vaccine viruses are closely related orthopoxviruses that are believed to share a common ancestor. Molecular analysis shows that horsepox is closer than modern vaccinia vaccines in DNA sequence to the vaccine discovered and disseminated by Dr. Edward Jenner. ^6-9 Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice.^4,6 The current formulation is a frozen liquid, but we believe that future lyophilized versions can be stored and shipped at standard refrigeration. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines that can be administered without sterile injection, manufactured using conventional cell culture systems with the potential for mass scale production, and packaged in multi-dose vials. Moreover, we believe the low dose of TNX-1800 makes this technology amenable for future implementation in microneedle delivery systems.

About TNX-801*
TNX-801 (recombinant horsepox virus) is a live virus vaccine based on horsepox^4-7 in pre-clinical development to prevent smallpox and mpox. Tonix reported positive preclinical efficacy data, demonstrating that TNX-801 vaccination protected non-human primates against lethal challenge with monkeypox.⁴Tonix has received official written response from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-801 as a potential vaccine to protect against mpox disease and smallpox.¹⁰ Tonix believes the FDA feedback provides a path to agreement on the design of a Phase 1 /2 study and the overall clinical development plan. The Phase 1/2 clinical trial will assess the safety, tolerability, and immunogenicity of TNX-801, following the submission and clearance of an IND. More than 30,000 people have contracted mpox in the U.S. so far during the 2022-23 epidemic,¹¹ The recent cluster of mpox in Chicago revealed breakthrough cases of mpox in individuals who had been vaccinated with the currently authorized non-replicating vaccine, which is administered in two doses.¹² In contrast, TNX-801 is delivered percutaneously with only one dose and therefore may achieve higher rates of community protection by eliminating drop-out between doses and limiting forward transmission. Moreover, relying on only one approved mpox vaccine at present is a risk for the global supply chain that has already led to insufficient availability of vaccines to meet global health needs, especially in Africa. TNX-801 has the potential to make a global impact on mpox and the risk of smallpox because of its durable T-cell immune response, the potential to manufacture at scale, and the use of a lower dose than non-replicating vaccines.

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. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), is in development as a preventive treatment for chronic migraine, and enrollment has been 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.

¹ TNX-1800 and TNX-801 are experimental new vaccines and have not been approved for any indication.
² Awasthi, M. et al. Viruses. 2023. 15(10):2131.
³ Awasthi, M. et al. BioRxiv. 2023.
⁴ Trefry S, et al. BioRxiv. 2023.
⁵ Noyce RS, et al. Viruses. 2023. 15(2):356.
⁶ Jenner E. “An Inquiry Into the Causes and Effects of the Variole Vaccinae, a Disease Discovered in Some of the Western Counties of England, Particularly Gloucestershire and Known by the Name of the cow‐pox.” London: Sampson Low, 1798.
⁷ Noyce RS, et al. PloS One. 2018. 13(1):e0188453.
⁸ Schrick L et al. N Engl J Med. 2017. 377:1491-1492.
⁹ Tulman ER, et al. J Virol. 2006. 80(18):9244-58.
¹⁰ TNX-801 PR pre-IND meeting August 20, 2023: https://ir.tonixpharma.com/news-events/press-releases/detail/1417/tonix-pharmaceuticals-announces-results-of-pre-ind-meeting
¹¹ McQuiston JH, et al. MMWR Morb Mortal Wkly Rep. 2023. 72:547–552.
¹² Centers for Disease Control. MMWR Morb Mortal Wkly Rep. 2023. 72(25);696-698.

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

Source: Tonix Pharmaceuticals Holding Corp.

Released November 2, 2023

Release – Ocugen to Host Conference Call on Thursday, November 9 at 8:30 A.M. ET To Discuss Business Updates and Third Quarter 2023 Financial Results

Posted on November 2, 2023November 2, 2023 by [email protected]

Research News and Market Data on OCGN

November 2, 2023

PDF Version

MALVERN, Pa., Nov. 02, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that it will host a conference call and live webcast to discuss the Company’s third quarter 2023 financial results and provide a business update at 8:30 a.m. ET on Thursday, November 9, 2023.

Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on the call using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 1787631
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
[email protected]

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

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

Research News and Market Data on XELB

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.

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

Forward Looking Statements

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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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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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

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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.

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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).