Health Archives - Page 5 of 207

Release – Nutriband Receives Notice Of Allowance For New U.S. Patent Covering Its Transdermal Abuse Deterrent Technology Aversa™

Posted on February 7, 2025February 7, 2025 by aweinsoff@channelchek.com

The AVERSA™ transdermal abuse deterrent technology is protected by a broad international intellectual property portfolio with patents already issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia

February 07, 2025 08:45 ET

ORLANDO, Fla., Feb. 07, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) on February 3, 2025 for patent application 18/369,241, “Abuse and Misuse Deterrent Transdermal Systems” which covers its Aversa™ abuse deterrent technology. The receipt of a Notice of Allowance means that the USPTO is expected to issue a U.S. patent for this application after administrative processes have been completed.

The expected issuance of this patent further expands Nutriband’s intellectual property protection in the United States for its portfolio of abuse deterrent transdermal products based on its proprietary Aversa™ abuse deterrent technology. This technology can be incorporated into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. Nutriband’s lead product under development is Aversa™ Fentanyl, an abuse deterrent fentanyl transdermal system, with the potential to become the first and only abuse deterrent pain patch on the market.

Nutriband’s AVERSA™ abuse-deterrent technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The technology consists of a proprietary aversive agent coating that employs taste aversion to deter the oral abuse of and accidental exposure to transdermal opioid and stimulant patch products.

The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

AVERSA Fentanyl has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million.¹

____________________________________________

¹ Health Advances Aversa Fentanyl market analysis report 2022

About AVERSA™ Abuse-Deterrent Transdermal Technology

Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

About Nutriband Inc.

We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words “believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Form 10-K for the year ended January 31, 2024, filed May 1, 2024, the Forms 10-Q’s filed subsequent to the Form 10-K in 2024, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Contact Information:

Nutriband Inc.
Phone: 407-377-6695
Email: Support@nutriband.com

SOURCE: Nutriband Inc.

Release – Eledon Pharmaceuticals Announces Use of Tegoprubart as Key Component of Immunosuppression Regimen in its Second Transplant of a Genetically Modified Pig Kidney into a Human

Posted on February 7, 2025February 7, 2025 by aweinsoff@channelchek.com

Research News and Market Data on ELDN

February 7, 2025

PDF Version

Patient treated in procedure, conducted at Mass General Transplant Center and in collaboration with partner eGenesis, was recently released from hospital

Investigational therapy tegoprubart targets CD40 ligand (CD40L) with potential to improve both safety and efficacy compared to standard of care immunosuppression regimens

IRVINE, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40L antibody, was used as a key component of the immunosuppression therapy regimen in a patient who recently received a transplanted kidney from a genetically modified pig. The procedure was performed on January 25, 2025, by surgeons at Massachusetts General Hospital (MGH) in collaboration with our partner eGenesis. In December 2024, MGH received Food and Drug Administration (FDA) approval to proceed with this transplant and plans to perform two additional xenotransplants this year, further advancing the field of xenotransplantation. Following the successful transplant, the patient was discharged from the hospital and is now off dialysis for the first time in over two years.

“This second kidney xenotransplant conducted at MGH represents another important milestone in the effort to consider new strategies in transplantation and immunosuppression to address the global organ shortage crisis. We are grateful to the patient, the team at MGH, and our partner eGenesis for supporting tegoprubart’s central role in these landmark procedures,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “Blocking the CD40 Ligand is a critical component of the immunosuppression regimen for effective translation of organ transplant from nonhuman primates into humans. Our anti-CD40L antibody tegoprubart represents a novel approach to immunosuppression therapy with the potential to improve safety and efficacy and enable patients to live longer with their transplanted organs.”

Similar to the first-ever kidney xenotransplant, also conducted at MGH in March 2024, tegoprubart is being administered to the current patient investigationally as part of a regimen designed to prevent the body from rejecting the transplanted pig organ. Tegoprubart is designed to block CD40L and has been shown to inhibit multiple costimulatory receptors including CD40 and CD11, key components of how immune cells communicate with one another. Based on extensive prior research, tegoprubart has been observed to be generally safe and well-tolerated in multiple potential indications, including for the prevention of rejection following kidney allotransplantation.

“I would like to thank Eledon for their work supporting this historic xenotransplant. Immunosuppression presents one of the greatest challenges for transplantation in both human and non-human organs. The need for advancements in immunosuppressive medications is critical for advancing our field and improving the quality of life for transplant patients everywhere,” said Dr. Leonardo Riella, MD, PhD, Medical Director for Kidney Transplantation at Massachusetts General Hospital.

Tegoprubart was also used as a cornerstone component of the chronic immunosuppression regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human, performed at the University of Maryland Medical Center in September 2023. Currently, tegoprubart is being evaluated in three global clinical studies for the prevention of organ rejection in patients receiving kidney transplants and in a separate investigator sponsored trial for the prevention of islet transplant rejection in patients with type 1 diabetes (T1D). Eledon recently announced initial data from this investigator-initiated islet transplant trial, conducted by the research team at the University of Chicago Medicine Transplant Institute, that demonstrated potentially the first human cases of insulin independence achieved using an anti-CD40L monoclonal antibody therapy without the use of tacrolimus, the current standard of care for prevention of transplant rejection.

The Company plans to report updated interim clinical trial from its ongoing Phase 1b and long-term safety and efficacy extension studies in kidney transplant this summer, topline results from its Phase 2 BESTOW kidney transplant trial in the fourth quarter of 2025, and longer-term follow up results from the investigator-led islet transplant clinical trial at UChicago Medicine Transplant Institute later this year.

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 the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. 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, 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 sites, 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
stephen@gilmartinir.com

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
jurban@cglife.com

Source: Eledon Pharmaceuticals

Release – Tonix Pharmaceuticals Recently Announced Preliminary Full Year 2024 Operating Results and Year-End Cash

Posted on February 7, 2025February 7, 2025 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

February 07, 2025 8:30am EST Download as PDF

Company had $98.8 million in cash as of December 31, 2024; existing cash expected to fund planned operations into the first quarter of 2026

Company is debt-free after repaying mortgage on facilities

TNX-102 SL fibromyalgia FDA PDUFA goal date is August 15, 2025

$10.1 million in net sales from migraine products in 2024

CHATHAM, N.J., Feb. 07, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, recently announced selected preliminary operating results for the year ended December 31, 2024, and certain preliminary financial condition information as of December 31, 2024.

Preliminary Full Year 2024 Financial Results¹

The Company had approximately $98.8 million in cash and cash equivalents as of December 31, 2024.
Net cash used in operating activities was approximately $60.9 million, compared to $102.0 million for the prior year.
Capital expenditures was approximately $0.1 million, compared to $29.1 million for the prior year.
Net operating loss was approximately $126.6 million, which includes non-cash impairment charges of approximately $59.0 million, compared to net operating loss of $116.7 million for the prior year.
The Company announced that net revenue from the sale of its marketed products was approximately $10.1 million, compared to $7.8 million for the prior year.
On February 3, 2025, the Company repaid a mortgage (Loan and Guaranty Agreement) with JGB Capital and related parties that was secured by two facilities and the Company is now debt-free.

The Company expects that its cash resources at December 31, 2024, and the gross proceeds of approximately $30.4 million raised from sales under its at-the-market facility in the first quarter of 2025, will be sufficient to fund its planned operations into the first quarter of 2026.

The cash runway is expected to fund the company beyond the August 15, 2025 Prescription Drug User Fee Act (PDUFA) goal date assigned by the U.S. Food and Drug Administration (FDA) for a decision on marketing authorization for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia.

¹ The above information is preliminary financial information for the year ended December 31, 2024 and subject to completion. The unaudited, estimated results for the year ended December 31, 2024 are preliminary and were prepared by the Company’s management, based upon its estimates, a number of assumptions and currently available information, and are subject to revision based upon, among other things, quarter and year-end closing procedures and/or adjustments, the completion of the Company’s consolidated financial statements and other operational procedures. This preliminary financial information is the responsibility of management and has been prepared in good faith on a consistent basis with prior periods. However, the Company has not completed its financial closing procedures for the year ended December 31, 2024, and its actual results could be materially different from this preliminary financial information, which preliminary information should not be regarded as a representation by the Company or its management as to its actual results for the year ended December 31, 2024. In addition, EisnerAmper LLP, the Company’s independent registered public accounting firm, has not audited, reviewed, compiled, or performed any procedures with respect to this preliminary financial information and does not express an opinion or any other form of assurance with respect to this preliminary financial information. During the course of the preparation of the Company’s financial statements and related notes as of and for the year ended December 31, 2024, the Company may identify items that would require it to make material adjustments to this preliminary financial information. As a result, prospective investors should exercise caution in relying on this information and should not draw any inferences from this information. This preliminary financial information should not be viewed as a substitute for full financial statements prepared in accordance with United States generally accepted accounting principles and reviewed by the Company’s auditors.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace^® SymTouch^® (sumatriptan injection) 3 mg and Tosymra^® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

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

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

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Peter Vozzo
ICR Healthcare
peter.vozzo@icrhealthcare.com
(443) 213-0505

Media Contact

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

Indication and Usage

Zembrace^® SymTouch^® (sumatriptan succinate) injection (Zembrace) and Tosymra^® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information

Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded

Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace or Tosymra if you have:

history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace and Tosymra may cause serious side effects including:

changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.

This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Source: Tonix Pharmaceuticals Holding Corp.

Released February 7, 2025

Release – Cadrenal Therapeutics Announces Chief Medical Officer Transition to Advance Clinical Development of Tecarfarin

Posted on February 6, 2025February 6, 2025 by aweinsoff@channelchek.com

Research News and Market Data on CVKD

James J. Ferguson, MD, FACC, FAHA, joins as Chief Medical Officer
Extensive experience provides strong support for advancing specialized cardiovascular assets, including leading the late-stage clinical development of tecarfarin and other business development opportunities

PONTE VEDRA, Fla. – Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company focused on the development of specialized cardiovascular therapies, with the late-stage asset tecarfarin, a new Vitamin K antagonist, today announced a leadership transition appointing James J. Ferguson, MD, FACC, FAHA, as its new Chief Medical Officer, effective immediately. Dr. Ferguson is a distinguished medical expert with over 25 years of leadership in the cardiovascular field and deep expertise in clinical development. Dr. Ferguson will lead the late-stage clinical development of tecarfarin to include the pivotal trial in LVAD patients and other indications in rare cardiovascular conditions requiring life-long anticoagulation therapy as well as other business development opportunities to build the Company’s pipeline.

Dr. Ferguson replaces Douglas W. Losordo, MD. Cadrenal thanks Dr. Douglas Losordo for his contributions to advancing the development of our tecarfarin program.

“We welcome Dr. Ferguson to our team and are confident that he will play a critical role in driving the late-stage clinical development of tecarfarin and the prioritization of indications. Dr. Ferguson brings expertise and strong relationships with cardiovascular clinical and scientific thought leadership, which will be instrumental as we prepare for late-stage clinical development of our tecarfarin program,” said Quang X. Pham, Chief Executive Officer, Cadrenal Therapeutics, Inc.

Dr. Ferguson joins Cadrenal after serving as Chief Medical Officer at Matinas BioPharma. Previously, Dr. Ferguson was Head of U.S. Cardiovascular Medical Affairs at Amgen and held several senior positions at AstraZeneca, including Vice President of US Cardiovascular Medical and Scientific External Relations, Therapeutic Area Vice President of Cardiovascular Global Medical Affairs, and US Development brand leader for BRILINTA.

“I’m truly honored to be joining Cadrenal at this exciting and transformative time. I look forward to advancing the late-stage clinical development of tecarfarin and bringing forward the first innovation in vitamin K-targeted anticoagulation in 70 years. This product could have a truly meaningful impact for patients in whom there continues to be major unmet medical needs with standard warfarin therapy,” said Dr. Ferguson.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company focused on developing specialized therapeutics for rare cardiovascular conditions. The Company is developing tecarfarin, a vitamin K antagonist (VKA) designed to be a better and safer anticoagulant than warfarin for individuals with implanted cardiac devices. Cadrenal strives to improve outcomes and reduce major adverse events for these patients. Although warfarin is widely used off-label for several rare cardiovascular diseases, extensive clinical and real-world data have shown it to have significant serious side effects. With its innovation, Cadrenal aims to meet the unmet needs of this patient population by relieving them and their healthcare providers of some of warfarin’s greatest clinical challenges.

Cadrenal is pursuing a product in a pipeline approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted left ventricular assist devices (LVADs). In 2025, the Company plans to initiate a pivotal Phase 3 trial evaluating tecarfarin versus warfarin for LVAD patients. The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib).

Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus to build a pipeline of specialized cardiovascular therapies. For more information, visit www.cadrenal.com and connect with us on LinkedIn.

Safe Harbor

Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding the contributions to be made by Dr. Ferguson including leading the late-stage clinical development of tecarfarin to include the pivotal trial in LVAD patients and other indications in rare cardiovascular conditions requiring life-long anticoagulation therapy as well as other business development opportunities to build the Company’s pipeline, as well as advancing other indications in rare cardiovascular conditions requiring chronic anticoagulation; playing a critical role in driving the late-stage clinical development of tecarfarin and the prioritization of indications; Dr. Ferguson’s expertise and strong relationships with cardiovascular clinical and scientific thought leadership being instrumental as the Company prepares for the for late-stage clinical development of our tecarfarin programs; advancing the late-stage clinical development of tecarfarin and bringing forward the first innovation in vitamin K-targeted anticoagulation in 70 years; the product having a truly meaningful impact for patients in whom there continues to be major unmet medical needs with standard warfarin therapy; the Company striving to improve outcomes and reduce major adverse events for patients; the Company aiming to meet the unmet needs of the patient population by relieving them and their healthcare providers of some of warfarin’s greatest clinical challenges; and the Company initiating in 2025 a pivotal Phase 3 trial evaluating tecarfarin versus warfarin for LVAD patients. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to derive benefits from the contributions expected to be made by Dr. Ferguson; the ability to initiate the pivotal Phase 3 clinical trial for tecarfarin in LVAD patients in 2025 and provide improved outcomes; the ability to enter into collaborations with development partners; the ability of tecarfarin to provide a safer alternative to LVAD patients and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250206066131/en/

Lisa DeScenza

LaVoieHealthScience

(978) 395-5970

ldescenza@lavoiehealthscience.com

Release – Tonix Pharmaceuticals Announces Positive Topline Results from Phase 1 Trial for TNX-1500, a Next Generation anti-CD40L mAb Candidate for Prevention of Kidney Transplant Rejection and Treatment of Autoimmune Diseases

Posted on February 6, 2025February 6, 2025 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

February 06, 2025 8:00am EST Download as PDF

Results from the Phase 1 single ascending dose study support proceeding to develop a Phase 2 trial for the prevention of kidney transplant rejection

TNX-1500 blocked the primary and secondary antibody responses to a test antigen at the 10 mg/kg and 30 mg/kg i.v. doses

TNX-1500 showed mean half-life of 34-38 days for the 10 mg/kg and 30 mg/kg doses supporting monthly dosing for future efficacy trials

TNX-1500 was generally well-tolerated with a favorable safety profile

Anti-CD40L has multiple potential indications in addition to solid organ and bone marrow transplantation including autoimmune diseases: potential pipeline in a product

CHATHAM, N.J., Feb. 06, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced positive topline results from its Phase 1, single ascending dose trial of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* in healthy participants. The objectives of the Phase 1 trial were to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous TNX-1500, as well as to support dosing in a planned Phase 2 trial in kidney transplant recipients.

“There remains a significant need for new agents with improved activity and safety to prevent transplant rejection and treat autoimmune diseases,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “First generation anti-CD40L mAb therapy, particularly ruplizumab (a.k.a., humanized 5c8 or BG9588) showed activity in modulating autoimmunity and rejection in allo- and xeno-transplantation but was limited by an increased risk of thrombosis.¹^-3 Tonix created TNX-1500, a next generation anti-CD40L mAb, by reengineering the Fc region of ruplizumab, to preserve activity with improved safety. The results of the Phase 1 study indicate that TNX-1500 has met these design objectives. We believe the results of this study and our prior animal studies^4,5 indicate that TNX-1500 is potentially best-in-class among next-generation anti-CD40L mAbs in development.”

Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals said, “Topline results from the TNX-1500 Phase 1 study showed TNX-1500 at the 10 mg/kg and 30 mg/kg doses blocked both the primary and secondary antibody responses to a test antigen. The pharmacokinetic data support monthly dosing at doses of 10 mg/kg or above. Based on these findings, we are eager to advance this promising candidate into a Phase 2 efficacy study. We believe TNX-1500 has the potential to prevent organ transplant rejection and improve graft survival with reduced long-term toxicity burden relative to current immunosuppressive regimens.”

Methods and Topline Results

Dosing: TNX-1500 solution was infused i.v. over a period of one hour to achieve doses of 3 mg/kg, 10 mg/kg, and 30 mg/kg. Participants were observed in the clinic for one day and followed with periodic clinic visits to Day 120.
Keyhole Limpet Hemocyanin (KLH) Challenge: To evaluate the immune modulation potency of TNX-1500, participants received an antigen challenge with KLH (Immucothel^®) administered subcutaneously (SC) on Day 2 and Day 29 of the study.
Disposition: A total of 26 participants were enrolled in three Cohorts (3 mg/kg, 10 mg/kg, and 30 mg/kg). A total of 24 participants completed the study and two discontinued early (one placebo participant was lost to follow-up and one on TNX-1500 withdrew consent).
Tolerability: TNX-1500 was generally well-tolerated with a favorable safety and tolerability profile. The only treatment-emergent adverse event (TEAE) occurring in ≥ 3 participants among all TNX-1500 groups was aphthous ulcer, occurring in one participant each in the 3 mg/kg, 10 mg/kg, and 30 mg/kg groups; all were rated as mild, possibly related, and resolved in 2-10 days. There were no TEAEs assessed as related to KLH administration. No TEAEs led to study discontinuation and there were no serious adverse events. There were no thromboembolic events, which were prespecified as TEAEs of special interest.
Pharmacodynamics: TNX-1500 at 10 mg/kg and 30 mg/kg blocked both the primary and secondary anti-KLH Ab responses, evidenced by the mean Ab level at all sampled timepoints (through Day 120) being below the lower limit of quantitation (400 µg/L). TNX-1500 at 3 mg/kg blocked the primary response to KLH Day 2 challenge and reduced the peak secondary response to KLH Day 29 challenge by approximately two thirds (69%) relative to the peak response to placebo.
Pharmacokinetics: The mean (SD) half-life of TNX-1500 was: 3 mg/kg, 19.6 (9.29) days; 10 mg/kg, 37.8 (5.46) days; and 30 mg/kg, 33.7 (4.83) days.

Tonix plans to discuss these results with the U.S. Food and Drug Administration (FDA) in an End-of-Phase 1 meeting. Pending alignment with the FDA, a Phase 2 study of TNX-1500 in kidney transplant recipients will be pursued.

About TNX-1500

TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that binds and functionally inhibits the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. Two published articles in the American Journal of Transplantation demonstrate TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent or in combination with other drugs in non-human primate renal and heart allografts. ^4,5

*TNX-1500 is an investigational new biologic and is not approved for any indication

Citations

Lederman S, et al, J Exp Med. 1992;175(4):1091-101. doi: 10.1084/jem.175.4.1091. PMID: 1348081; PMCID: PMC2119166.
Boumpas DT, et. al. Arthritis Rheum. 2003;48(3):719-27. doi: 10.1002/art.10856. PMID: 12632425.
Pierson RN 3rd, et al. Transplantation. 1999;68(11):1800-5. doi: 10.1097/00007890-199912150-00026. PMID: 10609959.
Lassiter G, et al. Am J Transplant. 2023;23(8):1171-1181. doi: 10.1016/j.ajt.2023.03.022.
Miura S, et al. Am J Transplant. 2023;23(8):1182-1193. doi: 10.1016/j.ajt.2023.03.025.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the U.S. National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

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

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

Forward Looking Statements

Investor Contact

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

Peter Vozzo
ICR Healthcare
peter.vozzo@icrhealthcare.com
(443) 213-0505

Media Contact

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

Indication and Usage

Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information

discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded

Do not use Zembrace or Tosymra if you have:

history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace and Tosymra may cause serious side effects including:

changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before

The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrance only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Source: Tonix Pharmaceuticals Holding Corp.

Released February 6, 2025

Release – GeoVax Anticipates Significant 2025 Progress with Catalyst-Rich Milestones Across Key Programs

Posted on February 5, 2025February 6, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Strategic Progress Across COVID-19, Mpox, Oncology Therapies and AI Integration Positions GeoVax for Strong Momentum

Atlanta, GA – February 5, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today outlined its 2025 strategic milestones and business outlook. Building on a history of delivering on key commitments, GeoVax enters 2025 with a robust pipeline, a catalyst-rich milestone schedule, and an unwavering commitment to addressing unmet medical needs on a global scale.

An Important Year Ahead for GEO-CM04S1, a Next-Generation COVID-19 Vaccine

GEO-CM04S1 continues to demonstrate potential for both immunocompromised patients and as a booster vaccine for those previously inoculated with mRNA vaccines. In 2025, the Company anticipates completion of the evaluation trial among Chronic Lymphocytic Leukemia (CLL) patients, a patient population recognized to currently have minimal COVID-19 vaccine options. Interim data reported in Q4 2024 suggest GEO-CM04S1 may offer superior immune responses to CLL patients compared to an mRNA vaccine.

GeoVax also expects to report final results from its healthy adults booster trial, offering valuable data on the vaccine’s safety and immunogenicity profile. Another pivotal milestone for GEO-CM04S1 in 2025 is the anticipated initiation of patient enrollment in the BARDA-funded Project NextGen Phase 2b trial, which will evaluate GEO-CM04S1 compared to an authorized mRNA vaccine within a 10,000-patient study. As both a booster and a primary vaccine for immune-compromised patient populations, GEO-CM04S1 remains central to GeoVax’s mission to address the ongoing and evolving challenges of COVID-19.

As part of its strategy, GeoVax will continue to explore and establish strategic partnerships and collaborations to accelerate the development, commercialization, and global accessibility of GEO-CM04S1.

GEO-MVA: Addressing Biosecurity and Global Health Gaps

GEO-MVA, a vaccine designed to combat Mpox and Smallpox, has emerged as a critical solution amid rising global biosecurity concerns. In 2025, the Company plans to initiate clinical evaluations for GEO-MVA while continuing discussions with various stakeholders regarding the opportunity to utilize GEO-MVA among underserved populations in regions including Africa. With ongoing geopolitical and logistical challenges limiting vaccine availability, GEO-MVA’s ability to offer multi-disease protection, minimal refrigeration needs, and scalability through implementation of an advanced MVA manufacturing process, GEO-MVA represents a potential transformative resource for both national biosecurity strategies and global health initiatives.

GeoVax recognizes that addressing these critical global challenges requires collaborative efforts. In 2025, the Company will actively pursue strategic partnerships with governments, NGOs, and private-sector stakeholders to maximize the impact and reach of its GEO-MVA platform.

Gedeptin: Unlocking Potential in Solid Tumor Cancer Therapy

GeoVax’s oncology program, centered around Gedeptin^®, continues to progress in addressing unmet medical needs in solid tumor therapies. Following encouraging results from Phase 1 and Phase 1/2 trials, Gedeptin is advancing into a Phase 2 clinical trial in 2025, where it will be evaluated in combination with an immune checkpoint inhibitor, targeting first recurrent head and neck cancer. This trial aims to validate the potential synergy between Gedeptin’s targeted gene-directed enzyme prodrug therapy and the powerful immune responses activated by checkpoint inhibitors.

As an FDA-designated Orphan Drug for anatomically accessible oral and pharyngeal cancers, Gedeptin is strategically positioned to address not only head and neck cancers but also other solid tumor indications, such as triple-negative breast cancer, soft tissue sarcoma and melanoma. GeoVax’s clinical roadmap for Gedeptin represents a significant market opportunity, with the potential to reshape how these cancers are treated worldwide.

GeoVax remains open to collaborations with oncology leaders, academic research institutions, and industry partners to further enhance the clinical impact and commercial success of Gedeptin.

Next-Generation Manufacturing: Pioneering Scalable Vaccine Production

To amplify the value of its clinical programs, GeoVax is also focused on advancing MVA vaccine manufacturing through validation of continuous cell line manufacturing processes, ensuring consistent, high-quality vaccine production capabilities. These advancements address long-standing challenges in vaccine scalability and cost-effectiveness, positioning GeoVax as a leader in MVA-based vaccine manufacturing solutions, potentially implementing a proprietary MVA manufacturing process supporting more flexible, localized MVA manufacturing at lower production cost, specifically enabling vaccine self-sufficiency manufacturing in low-middle income regions such as Africa.

GeoVax recognizes that strong manufacturing partnerships are vital to bringing these innovations to market efficiently and cost-effectively. The Company plans to collaborate with manufacturing partners worldwide to scale up production capabilities and meet the growing global demand for MVA-based vaccines.

AI Integration: Optimizing Processes and Driving Innovation

In alignment with its 2025 objectives, GeoVax has expanded the integration of Artificial Intelligence (AI) across its vaccine development and cancer immunotherapy activities. Leveraging AI is anticipated to accelerate vaccine development, optimize cancer therapies, streamline clinical trials, and enhance manufacturing processes, potentially in the following manners:

Vaccine and Therapy Innovation: Predicting pathogen mutations and optimizing GEO-CM04S1 and Gedeptin^® design, ensuring effectiveness in variant-proof vaccines and cancer therapies.
Clinical Trial Optimization: Refining patient selection, accelerating recruitment, and enhancing diversity for trials targeting high-risk and underserved populations.
Streamlined Manufacturing: Enhancing scalability and logistics, enabling efficient production and distribution, particularly in underserved regions.

Addressing a $55+ Billion Pipeline Market Opportunity

GeoVax’s pipeline addresses significant unmet and underserved medical needs worldwide in both infectious disease vaccines and oncology, representing a collective potential global market opportunity in excess of $55 billion. Each program—GEO-CM04S1, GEO-MVA, and Gedeptin—addresses significant gaps in existing treatment and prevention strategies, backed by emerging clinical data and a focus towards achieving the necessary regulatory milestones in support of product registration.

David Dodd, Chairman & CEO of GeoVax, commented: “2024 was a transformative year for GeoVax, and our focus and commitment in 2025 is unwavering, focused on critically needed unmet medical needs. Our pipeline, enriched with value-driven milestones, positions us well for successful growth and development. Collaborations and partnerships remain core to our strategy, ensuring our innovations reach those who need them most. With GEO-CM04S1, GEO-MVA, Gedeptin, our MVA manufacturing advancements, and leveraging AI to optimize our processes and drive innovation, we are prepared to make meaningful contributions to global health, delivering value to our fellow shareholders, various stakeholders and, providing compelling career development opportunities to our staff colleagues.”

For further details on GeoVax’s pipeline and strategic initiatives, please visit www.geovax.com.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) 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, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin^® combined with an immune checkpoint inhibitor is planned to initiate during the first half of 2025. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

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

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

Company Contact:	Investor Relations Contact:	Media Contact:
info@geovax.com	austin.murtagh@precisionaq.com	sr@roberts-communications.com
678-384-7220	212-698-8696	202-779-0929

Release – PDS Biotech Reaffirms Guidance for First Quarter Initiation of VERSATILE-003 Phase 3 Clinical Trial in HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Posted on February 5, 2025February 6, 2025 by aweinsoff@channelchek.com

Research News and Market Data on PDSB

FDA-cleared amended trial design; First site initiation expected Q1 2025

PRINCETON, N.J., Feb. 05, 2025 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today reaffirmed the Company’s guidance of initiating its VERSATILE-003 Phase 3 clinical trial of Versamune^® HPV plus pembrolizumab for first-line treatment of recurrent and/or metastatic (R/M) HPV16-positive head and neck squamous cell cancer (HNSCC) in the first quarter of this year.

PDS Biotech submitted its updated clinical protocol on November 15, 2024, amending the Investigational New Drug (IND) application. The window for comments from the U.S. Food and Drug Administration (FDA) has passed, and the Company is on track to initiate site activation in the first quarter of 2025. The Company has received Fast Track designation from the FDA for the combination of Versamune^® HPV and pembrolizumab in R/M HNSCC. (See VERSATILE-002 Phase 2 clinical results here.)

“The integral elements for trial initiation are ready, including alignment with the FDA,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We look forward to initiating VERSATILE-003 this quarter and advancing the combination of Versamune^® HPV plus pembrolizumab to potentially provide improved outcomes for patients with HPV16-positive R/M HNSCC.”

HPV16-positive patients represent a large, fast-growing subgroup in need of targeted therapies to treat the underlying cause of the cancer. A recently validated companion diagnostic to confirm HPV16-positive HNSCC will be utilized during the patient screening process of the VERSATILE-003 trial.

“HPV16-positive HNSCC is poised to become the dominant type of HNSCC in the US and EU,” said Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer. “Confirming HPV16 status with a potentially commercializable test is essential to effectively identifying the patients suitable to receive Versamune HPV. This will be the first investigational use of this type of companion diagnostic in a Phase 3 clinical trial in HNSCC.”

For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966).

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company plans to initiate a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational T-cell stimulating immunotherapy Versamune^® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.

For more information, please visit www.pdsbiotech.com

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for Versamune^® HPV, PDS01ADC and other Versamune^® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning Versamune^® HPV, PDS01ADC and other Versamune^® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  

Versamune^® is a registered trademark of PDS Biotechnology Corporation.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
Janine McCargo
6 Degrees
Phone +1 (646) 528-4034
Email: jmccargo@6degreespr.com

Teladoc Health to Acquire Catapult Health, Expanding Preventive and At-Home Care Offerings

Posted on February 5, 2025February 5, 2025 by cpatches

Key Points:
– Teladoc Health is acquiring Catapult Health for $65 million to enhance its preventive care and at-home diagnostic testing capabilities, further strengthening its integrated healthcare solutions.
– Catapult Health’s VirtualCheckup program will enable Teladoc to expand its chronic condition management services and seamlessly connect high-risk patients to virtual care programs.
– This acquisition comes as Teladoc seeks to regain momentum following its 2020 Livongo acquisition, which initially valued the combined company at $37 billion but has since declined to a market cap under $2 billion.

Teladoc Health has announced a definitive agreement to acquire Catapult Health, a move aimed at strengthening its preventive care and chronic condition management capabilities while expanding its at-home diagnostic testing offerings. This acquisition aligns with Teladoc’s strategy to enhance virtual care accessibility and effectiveness for its over 93 million members.

Catapult Health is recognized for its innovative approach to at-home wellness and diagnostic testing, which integrates virtual clinical support and high-touch patient engagement. Teladoc plans to leverage these capabilities to further enrich its industry-leading suite of integrated healthcare solutions.

“This acquisition will help advance our strategy in meaningful ways — from giving more members access to convenient and impactful wellness and preventive care, to unlocking greater value for our customers,” said Chuck Divita, Chief Executive Officer of Teladoc Health. “Catapult Health brings an experienced team and a strong culture of innovation, and we are thrilled to welcome them to Teladoc Health.”

Strategic Objectives and Synergies

Teladoc Health’s integrated care strategy is built on four key pillars:

Expanding Membership and Service Utilization – Enhancing the accessibility and engagement of healthcare services for existing and new members.
Leveraging Clinical Expertise and Product Breadth – Strengthening healthcare outcomes by integrating a broader range of clinical solutions.
Growing International Presence – Extending Teladoc’s reach beyond domestic markets to serve a global population.
Advancing Mental Health Solutions – Building upon its existing leadership in virtual mental health services.

Catapult Health’s flagship VirtualCheckup program exemplifies its innovation in preventive care. The at-home wellness exam provides members with a simple diagnostic kit, allowing them to collect blood samples, measure blood pressure, and submit other key health data. Following this, a virtual consultation with a licensed healthcare professional ensures timely assessment and guidance.

For members identified with high-risk factors or chronic conditions, Catapult’s clinicians can seamlessly enroll them into Teladoc’s condition management programs, including diabetes, hypertension, pre-diabetes, and weight management. Additionally, members can be referred to Teladoc’s virtual mental health specialists and primary care providers for continued support.

Transaction Details

The acquisition is structured as an all-cash transaction valued at $65 million, with up to $5 million in contingent earnout consideration. Catapult Health reported $30 million in trailing 12-month revenue as of Q3 2024. Upon closing, Catapult will be integrated into Teladoc’s Integrated Care segment. The deal is expected to close in Q1 2025.

Impact and Market Expansion

Catapult Health currently serves over 3 million people through its partnerships with hundreds of employer clients. The company is recognized for its strong customer satisfaction, clinical outcomes, and cost-saving benefits, including an estimated $1,400 average savings per participant over a three-year period due to early disease detection and health risk identification.

Teladoc’s Market Challenges and Context

This acquisition comes after a tumultuous period for Teladoc. Following its acquisition of Livongo in 2020, the combined companies had an enterprise value of $37 billion. However, Teladoc’s stock has struggled since then, with a current market capitalization just under $2 billion. The acquisition of Catapult Health represents a strategic effort to regain momentum and strengthen its position in the evolving telehealth market.

Release – MAIA Biotechnology Announces Positive Efficacy Updates for Phase 2 THIO-101 Trial in Advanced Non-Small Cell Lung Cancer

Posted on February 4, 2025February 4, 2025 by aweinsoff@channelchek.com

Research News and Market Data on MAIA

February 04, 2025 8:51am EST Download as PDF

Median overall survival (OS) from THIO treatment extends to 16.9 months
Newest data strengthens regulatory strategy

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced positive updated data from its THIO-101 pivotal Phase 2 clinical trial evaluating its lead clinical candidate, THIO, sequenced with Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo^®) in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens.

As of January 15, 2025, third line (3L) data showed median overall survival (OS) of 16.9 months for the 22 NSCLC patients who received at least one dose of THIO (the intent-to-treat population) in parts A and B of the trial. The analysis demonstrated a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. The treatment has been generally well-tolerated to date in this heavily pre-treated population¹. Studies of standard-of-care (SOC) chemotherapy treatments for NSCLC in a similar setting have shown OS of 5 to 6 months.²

“Treatment with THIO now shows a 99% probability that overall survival will extend past chemotherapy’s measure by a wide margin,” said Vlad Vitoc, M.D., CEO of MAIA. “THIO’s efficacy in advanced stages of NSCLC continues to exceed our expectations, especially in third-line treatment where the cancer is typically even more resistant to therapy. Our findings suggest great benefits to patients with unmet medical needs who see little hope for the future.

“With our latest overall survival results, our outlook for potential FDA commercial approval of THIO is stronger than ever,” Dr. Vitoc concluded.

Based on its regulatory strategy, MAIA believes there could be an opportunity for accelerated FDA approval of THIO depending on final results from the ongoing expansion of the THIO-101 trial.

About THIO

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

About THIO-101, a Phase 2 Clinical Trial

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

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

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

__________________________

¹ Details on safety can be found on the previously announced SITC 2024 presentation available on MAIA’s website.

² Girard N, et al. J Thorac Onc 2009;12:1544-1549.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250204174307/en/

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

Source: MAIA Biotechnology, Inc.

Released February 4, 2025

Release – Tonix Pharmaceuticals Promotes Siobhan Fogarty to Chief Technical Officer

Posted on February 4, 2025February 4, 2025 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

February 04, 2025 7:00am EST Download as PDF

Ms. Fogarty has served at Tonix since 2016, most recently as Executive Vice President, Product Development

Tonix is Preparing for Potential Launch of TNX-102 SL for the management of fibromyalgia with U.S. FDA PDUFA goal date of August 15, 2025

CHATHAM, N.J., Feb. 04, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the promotion of Siobhan Fogarty to Chief Technical Officer (CTO), effective immediately. Ms. Fogarty joined Tonix in 2016 and previously served as Executive Vice President of Product Development. Ms. Fogarty has over 25 years of experience in pharmaceutical and biotech product development, manufacturing and quality, for both small and large molecules, at notable pharmaceutical and biotech companies.

In December, Tonix announced that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on marketing authorization for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia. TNX-102 SL is a non-opioid, centrally-acting analgesic. Fibromyalgia is a common chronic pain condition that affects mostly women.

“Siobhan is an invaluable member of our team and an outstanding leader who has contributed in many ways to our success since she joined in 2016, and we are excited that she is executing at a higher level in her new role as our first CTO,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Her energy, insights and organizational abilities will be welcome as we enter into a landmark time for the Company with the upcoming PDUFA goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia. In addition to her stewardship of TNX-102 SL, Siobhan has played key roles advancing our pipeline of small molecule, biologics and live-virus vaccines.”

Ms. Fogarty started her career with Elan Corporation as a formulation scientist where she gained experience in several different areas of drug delivery, including solid, liquids, IV, and transdermal formulations. At Elan, she took products from concept to commercial manufacture in both Ireland and the U.S. Ms. Fogarty moved to Glaxo SmithKline, London, as a manufacturing strategist after the merger of Glaxo and SmithKline Beecham. Returning to product development, Ms. Fogarty established European product development sites for Fuisz Technologies and Biovail Corporation, leading multi-disciplinary teams for the development of products from early conceptual/preclinical development, through the various clinical phases and transferring to U.S./Canadian manufacturing sites during registration for commercialization. Subsequently, Ms. Fogarty started a consultancy firm, eMSc, that advised pharmaceutical and biotech companies in product development and implementation of a phased approach to quality. Ms. Fogarty obtained her masters in Pharmaceutical Sciences at Trinity College, Dublin, and is a European Union Qualified Person. Her primary degree is in Industrial Chemistry from the University of Limerick where she interned at Pfizer.

“I am grateful for the incredible eight years I have already enjoyed working at Tonix and look forward to the challenges and opportunities of my new role,” said Ms. Fogarty. “Tonix is entering a momentous time, and it is an honor to assume these new responsibilities as part of this extraordinary team.”

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the area of infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace^® SymTouch^® (sumatriptan injection) 3 mg and Tosymra^® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

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

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

Forward Looking Statements

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Peter Vozzo
ICR Healthcare
peter.vozzo@icrhealthcare.com
(443) 213-0505

Media Contact

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

Indication and Usage

Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information

discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded

Do not use Zembrace or Tosymra if you have:

history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace and Tosymra may cause serious side effects including:

changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Source: Tonix Pharmaceuticals Holding Corp.

Released February 4, 2025

Release – GeoVax Announces Strategic Integration of AI in Support of President Trump’s Stargate Initiative

Posted on February 3, 2025February 3, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Harnessing AI to Revolutionize Vaccine and Therapy Development

ATLANTA, GA, February 3, 2025 — GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in vaccine and immunotherapy development, announced today its endorsement of President Donald J. Trump’s Stargate Initiative, which aims to harness advanced technologies including Artificial Intelligence (AI) to strengthen U.S. healthcare, biosecurity, and global innovation leadership. This announcement aligns with GeoVax’s commitment to leveraging AI across its vaccine and cancer immunotherapy programs to accelerate research, optimize operations, and deliver life-saving solutions.

Revolutionizing Healthcare with AI

GeoVax has embedded AI into its platforms for vaccine development and cancer immunotherapy, enabling groundbreaking advances:

Vaccine Development: AI drives target discovery and design for vaccines using the Modified Vaccinia Ankara (MVA) platform, including GEO-CM04S1, GeoVax’s next-generation vaccine for COVID-19, and vaccines for Mpox and Smallpox. AI predicts pathogen mutations, ensuring long-lasting and variant-proof vaccines.
Cancer Immunotherapy: AI optimizes GeoVax’s Gene-Directed Enzyme Prodrug Therapy (GDEPT) for solid tumors, including predictive modeling of tumor microenvironments, real-time adjustment of protocols to maximize therapeutic efficacy, and identifying synergistic combinations with immune checkpoint inhibitors.
Clinical Targeting: AI-powered analytics will refine patient stratification, ensuring that GeoVax’s therapies reach underserved populations most in need, aligning with the initiative’s national focus to maximize therapeutic efficacy.
Manufacturing and Operations: AI improves GeoVax’s vaccine production scalability and supply chain management, ensuring timely delivery to strategic stockpiles.

Aligned with the Stargate Vision

President Trump’s Stargate Initiative, supported by up to $500 billion in private-sector investment, represents a bold step forward in embracing transformative technologies. GeoVax proudly aligns with this vision, advancing U.S. healthcare innovation and pandemic preparedness.

David Dodd, GeoVax Chairman and CEO, stated: “President Trump’s Stargate Initiative exemplifies leadership in harnessing AI to address critical healthcare challenges. GeoVax is honored to support this initiative, highlighting its application of AI to develop vaccines and therapies that save lives and enhance biosecurity. We are proud to contribute to a future where the United States leads the world in healthcare innovation.”

Building on Operation Warp Speed’s Legacy

GeoVax’s efforts reflect the spirit of President Trump’s Operation Warp Speed, which accelerated COVID-19 vaccine development and deployment. By integrating AI into its research and operational strategies, GeoVax aims to continue pushing the boundaries of what is possible in medical science.

A Commitment to Life-Saving Innovation

GeoVax remains steadfast in its mission to develop innovative vaccines and immunotherapies, leveraging the power of AI to meet the healthcare needs of today and prepare for the challenges of tomorrow. With AI now embedded in its processes, GeoVax anticipates shorter development timelines, increased efficiency in clinical trials, and enhanced capacity to deliver life-saving therapies globally. Collaborations with academic institutions, industry partners and federal agencies will further amplify the reach and impact of GeoVax’s innovative programs under the Stargate framework. AI-enabled supply chain optimization will further ensure efficient vaccine distribution to high-priority populations and regions.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) 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, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin^® combined with an immune checkpoint inhibitor is planned to initiate in mid-2025. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

Company Contact:	Investor Relations Contact:	Media Contact:
info@geovax.com	austin.murtagh@precisionaq.com	sr@roberts-communications.com
678-384-7220	212-698-8696	202-779-0929

Release – Tonix Pharmaceuticals Announces 1-for-100 Reverse Stock Split

Posted on February 3, 2025February 3, 2025 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

February 03, 2025 8:05am EST

Download as PDF

CHATHAM, N.J., Feb. 03, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it will effect a 1-for-100 reverse stock split of its outstanding common stock. The reverse stock split will be effective for trading purposes as of the commencement of trading on February 5, 2025.

The reverse stock split is intended to increase the per share trading price of Tonix’s common stock to satisfy the $1.00 minimum bid price requirement for continued listing on The NASDAQ Capital Market (Rule 5550(a)(1)). Tonix’s common stock will continue to trade on the NASDAQ Capital Market under the symbol “TNXP” and under a new CUSIP number, 890260839. As a result of the reverse stock split, every one hundred pre-split shares of common stock outstanding will become one share of common stock. The reverse split will also apply to common stock issuable upon the exercise of Tonix’s outstanding warrants and stock options. The reverse stock split will not proportionately reduce the number of shares of authorized common stock, as permitted under Nevada law, as shareholder approval for the reverse stock split was obtained on October 30, 2024.

Tonix’s transfer agent, VStock Transfer LLC, which is also acting as the exchange agent for the reverse split, will provide instructions to shareholders regarding the process for exchanging share certificates. Any fractional shares of common stock resulting from the reverse stock split will be rounded up to the nearest whole post-split share and no shareholders will receive cash in lieu of fractional shares.

Tonix Pharmaceuticals Holding Corp.^*
Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has previously granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. In July 2024, Tonix announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

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

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

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

Forward Looking Statements

Investor Contacts

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Peter Vozzo
ICR Healthcare
peter.vozzo@icrhealthcare.com
(443) 213-0505

Media Contact

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

_____________________________________

Indication and Usage
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded

Do not use Zembrace or Tosymra if you have:

history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:

changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before

The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Source: Tonix Pharmaceuticals Holding Corp.

Released February 3, 2025

Release – Ocugen Announces Positive Opinion of European Medicines Agency’s Committee for Advanced Therapies for Advanced Therapy Medicinal Product Classification for Modifier Gene Therapy Candidate OCU400 for Retinitis Pigmentosa

Posted on February 3, 2025February 3, 2025 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

February 3, 2025

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MALVERN, Pa., Feb. 03, 2025 (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 the European Commission has provided a positive opinion from the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) for OCU400 Advanced Therapy Medicinal Product (ATMP) classification. OCU400 is the first gene therapy to enter Phase 3 with a broad retinitis pigmentosa (RP) indication.

“Receiving ATMP classification is another significant milestone toward bringing OCU400 to the market in Europe,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “This designation makes it possible to stay on track with our clinical and commercial strategy and potentially provide this novel modifier gene therapy candidate to all RP patients in the United States (U.S.) and Europe by 2027.”

ATMP classification is granted to medicines that can offer groundbreaking opportunities for the treatment of disease and accelerates the regulatory review timeline of this potential one-time gene therapy for life. Additionally, this classification allows Ocugen to interact with EMA more frequently for scientific advice and protocol assistance as the Company pursues Marketing Authorization Application (MAA) filing in 2026.

Underscoring the vital need for gene-agnostic treatments for diseases with multiple mutations such as RP, both the U.S. Food and Drug Administration (FDA) and EMA have acknowledged that the ongoing single, pivotal Phase 3 trial of OCU400 can suffice for Biologics License Application (BLA)/MAA submissions. Ocugen intends to file simultaneously in the U.S. and Europe upon completion of the Phase 3 trial.

The Phase 3 OCU400 liMeliGhT clinical trial is currently enrolling. The study has a sample size of 150 participants—one arm of 75 participants with RHO gene mutations and the other arm with 75 participants that are gene agnostic. In each arm, participants will be randomized 2:1 to the treatment group (2.5 x 10¹⁰ vg/eye of OCU400) and untreated control group, respectively. Patients eight years of age and older, with early through late-stage advancement of RP, are being recruited to participate in the liMeliGhT study.

“We are encouraged by the EMA’s recognition of OCU400 as the Phase 3 liMeliGhT clinical trial advances,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “I look forward to working collaboratively with the EMA to address the unmet medical need that remains for nearly 98% of the RP patient population.”

RP affects nearly 310,000 patients in the U.S., EU, and Canada. Currently, RP is associated with mutations in more than 100 genes and there are no approved treatment options that slow or stop the progression of multiple forms of RP.

OCU400 is the Company’s gene-agnostic modifier gene therapy product based on NHR gene, NR2E3. NR2E3 regulates diverse physiological functions within the retina—such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation and cell survival networks. Through its drive functionality, OCU400 resets altered/affected cellular gene networks and establishes homeostasis—a state of balance, which has the potential to improve retinal health and function in patients with inherited retinal diseases.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies 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, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, 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, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU400 to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. 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
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com