Biopharmaceutical Archives

Release – Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia

Posted on December 17, 2024December 17, 2024 by aweinsoff@channelchek.com

December 17, 2024 8:00am EST Download as PDF

FDA is expected to assign a Prescription Drug User Fee Act (PDUFA) target action date and announce whether Priority Review has been granted in the Day 74 Letter

TNX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA

Fibromyalgia affects more than 10 million adults in the U.S. who are mostly women

TNX-102 SL has the potential to be the first member of a new class of analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years, if approved by FDA

NDA based on two statistically significant Phase 3 studies of TNX-102 SL for the management of fibromyalgia; in which TNX-102 SL was generally well tolerated

CHATHAM, N.J., Dec. 17, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets), a 5.6 mg, non-opioid, centrally-acting analgesic, for the management of fibromyalgia. The FDA is expected to assign the NDA a Prescription Drug User Fee Act (PDUFA) target action date in a Day 74 Letter. At that time, the FDA will also communicate to Tonix whether Priority Review has been granted. TNX-102 SL was granted Fast Track designation for fibromyalgia by the FDA in July of 2024. Fast Track is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need.

“The FDA’s acceptance of our NDA represents another step forward as we pursue our goal of delivering the first member of a new class of medicines for the management of fibromyalgia, a condition affecting over 10 million adults in the U.S.,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The fibromyalgia community, comprised of patients and their families and support groups, has been waiting for a new drug for over 15 years. Analysis of insurance claims in the U.S., commissioned by Tonix, have shown that 18 months after diagnosis, fibromyalgia patients were more likely to be prescribed addictive opioids than all three of the FDA-approved drugs combined.”

Dr. Lederman continued, “We look forward to working closely with the FDA throughout the NDA review period with the goal of bringing TNX-102 SL to the market to address the significant unmet needs of the fibromyalgia community as quickly as possible. Furthermore, this is an important milestone as we advance our commercial preparations in anticipation of a potential approval in 2025 with an accomplished commercial leadership team already in place, supporting our marketed products 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.”

The NDA is supported by data from two 14-week double-blind, randomized, placebo-controlled Phase 3 clinical trials evaluating the safety and efficacy of TNX-102 SL as a bedtime treatment for fibromyalgia. The first Phase 3 trial, RELIEF, of TNX-102 SL 5.6 mg in fibromyalgia, completed in December 2020, met its pre-specified primary endpoint of significantly reducing daily pain compared to placebo (p=0.010). In the confirmatory Phase 3 RESILIENT study in fibromyalgia, completed in December 2023, TNX-102 SL again met the pre-specified primary endpoint of significantly reducing daily pain compared to placebo (p =0.00005). In both trials, TNX-102 SL was generally well tolerated with an adverse event profile comparable to prior studies and with no new safety signals observed. In both pivotal studies, the most common treatment-emergent adverse event was tongue or mouth numbness at the administration site, which was temporally related to dosing, self-limited, never rated as severe, and rarely led to study discontinuation (one participant in each study). Excluding COVID-19, systemic adverse events in each of the two studies was lower than 4.0%. Tonix believes the submitted dossier contains the requisite safety and efficacy data from two adequate and well-controlled studies to support NDA approval.

About Fibromyalgia

Fibromyalgia is a common chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system, called central sensitization. Brain imaging studies have localized the functional disorder to the brain’s insula and anterior cingulate cortex. Fibromyalgia afflicts more than 10 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including depression, anxiety, headaches and abdominal pain or cramps. Individuals suffering from fibromyalgia often struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. Fibromyalgia is now recognized as the prototypic nociplastic syndrome. Nociplastic pain is the third primary type of pain in addition to nociceptive pain and neuropathic pain. Many patients present with pain syndromes that are a spectrum of mixtures of the three primary types of pain. Nociplastic syndromes are associated with central and peripheral sensitization. Fibromyalgia can occur without any identifiable precipitating event. However, many fibromyalgia cases follow one or more precipitating event(s) including: post-operative pain, acute or chronic nociceptive or neuropathic pain states; recovery from an infectious illness; a cancer diagnosis or cancer treatment; a metabolic or endocrine stress; or a traumatic event. In the cases of recovery from an infectious illness, fibromyalgia is considered an Infection-Associated Chronic Condition. In addition to fibromyalgia cases associated with other conditions or stressors, the U.S. National Academies of Sciences, Engineering, and Medicine, has concluded that fibromyalgia is a diagnosable condition that can occur after recovery from COVID-19 in the context of Long COVID. Fibromyalgia is also recognized as a Chronic Overlapping Pain Condition, which is a group of related conditions including, chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), irritable bowel syndrome, endometriosis, low back pain, post-concussive syndrome (also known as mild traumatic brain injury), chronic Lyme Disease, chronic diabetic neuropathy and chronic post-herpetic neuralgia.

About TNX-102 SL

TNX-102 SL is a centrally acting, non-opioid investigational drug, designed for chronic use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for bedtime dosing for the management of fibromyalgia. Cyclobenzaprine potently binds and acts as an antagonist at four different post-synaptic neuroreceptor subtypes: serotonergic-5-HT_2A, adrenergic-α₁, histaminergic-H₁, and muscarinic-M₁-cholinergic receptors. Together, these interactions are believed to target the non-restorative sleep characteristic of fibromyalgia that was identified by Professor Harvey Moldofsky in 1975. Cyclobenzaprine is not associated with risk of addiction or dependence. The TNX-102 SL tablet is based on a eutectic formulation of cyclobenzaprine HCl and mannitol that provides a stable product which dissolves rapidly and delivers cyclobenzaprine by the transmucosal route efficiently into the bloodstream. The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. Patents based on TNX-102 SL’s eutectic composition and its properties have issued in the U.S., E.U., Japan, China and many other jurisdictions around the world and provide market protection into 2034. The European Patent Office’s Opposition Division maintained Tonix’s European Patent EP 2 968 992 in unamended form after an Opposition was filed against it by a Sandoz subsidiary, Hexal AG. Hexal AG did not appeal that decision. The formulation of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep, while reducing the risk of daytime somnolence. Clinical pharmacokinetic studies indicated that relative to oral cyclobenzaprine, TNX-102 SL results in higher levels of exposure during the first 2 hours after dosing and in deceased levels of the long-lived active metabolite, norcyclobenzaprine in both single dose and multiple dose studies, consistent with bypassing first pass hepatic metabolism. At steady state after 20 days of dosing TNX-102 SL, the dynamic peak level of cyclobenzaprine is higher than the background level of norcyclobenzaprine. In contrast, after 20 days of dosing oral cyclobenzaprine, the simulated peak level of cyclobenzaprine is lower than the simulated background level of norcyclobenzaprine.

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. The FDA has accepted the NDA filing for TNX-102 SL for 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 of Drug Abuse and Addiction. 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 areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and 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

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) 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

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

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.

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 December 17, 2024

Release – Tonix Pharmaceuticals to Participate in the NobleCon20 Investor Conference

Posted on November 26, 2024November 26, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

November 26, 2024 7:00am EST

CHATHAM, N.J., Nov. 26, 2024 (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, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present and conduct investor meetings at NobleCon20, Noble Capital Markets’ Twentieth Annual Emerging Growth Equity Conference, being held December 3-4 in Boca Raton, Fla.

Investors interested in arranging a meeting with the Company’s management during the conference should contact the NobleCon conference coordinator. A video webcast of the presentation will be available the day following the presentation under the IR Events tab of the Tonix website at www.tonixpharma.com and as part of a complete catalog of presentations available at Noble Capital Markets’ Conference website at www.nobleconference.com and on Channelchek, the investor portal created by Noble Capital Markets, at www.channelchek.com.

Details of the Tonix Pharmaceuticals Presentation

Event:	NobleCon20, Noble Capital Markets’ Twentieth Annual Emerging Growth Equity Conference

Date:	Tuesday, December 3, 2024

Time:	12:00 p.m. ET

Location:	Florida Atlantic University, College of Business Executive Education (COBEE) Complex

Track:	Presentation Room 3

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. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. We expect an FDA decision on the acceptance of the NDA for review and a PDUFA date in December and if accepted, a decision on NDA approval in 2025. 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 of Drug Abuse and Addiction. 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 areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and 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

Source: Tonix Pharmaceuticals Holding Corp.

Released November 26, 2024

Poseida Therapeutics to Be Acquired by Roche in $1.5 Billion Deal

Posted on November 26, 2024November 26, 2024 by slightbourne@noblecapitalmarkets.com

Key Points:
– Poseida Therapeutics to be acquired by Roche for up to $1.5 billion, advancing the field of allogeneic CAR-T therapies.
– Poseida’s non-viral, TSCM-rich CAR-T therapies aim to enhance clinical outcomes and expand treatment access.
– Roche’s capabilities in late-stage development and commercialization will bring Poseida’s advancements to patients worldwide.

Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company pioneering allogeneic cell and genetic therapies, announced that it has entered into a definitive agreement to be acquired by Roche Holdings, Inc. in a transaction valued at up to $1.5 billion. Under the agreement, Poseida stockholders will receive $9.00 per share in cash upon closing, along with a contingent value right (CVR) for up to $4.00 per share upon achieving specified milestones. The acquisition has been unanimously approved by Poseida’s Board of Directors, which recommends that stockholders tender their shares.

The merger will bring Poseida’s advanced platform technologies and innovative therapies into Roche’s Pharmaceuticals Division. This acquisition marks a significant expansion of Roche’s capabilities in allogeneic cell therapy, a cutting-edge area of biotech innovation focused on creating “off-the-shelf” treatments. This collaboration builds on an ongoing strategic partnership between Poseida and Roche, particularly in developing CAR-T therapies for hematologic malignancies. The expanded scope will also include CAR-T programs targeting solid tumors and autoimmune diseases.

Poseida’s proprietary technology platform, which utilizes non-viral, T stem cell memory (TSCM)-rich CAR-T therapies, is at the forefront of innovation in cell therapy. TSCM cells are considered highly advantageous due to their long-lived, self-renewing, and multipotent properties, enabling potentially safer and more effective therapies. These characteristics differentiate Poseida’s therapies from other CAR-T approaches, which often rely on more differentiated cells with reduced regenerative capacity.

Highlighting Poseida’s potential, interim clinical data for P-BCMA-ALLO1, a CAR-T candidate for multiple myeloma, have shown compelling results. This reinforces the transformative potential of Poseida’s platform in addressing high unmet needs across various therapeutic areas. Kristin Yarema, Ph.D., President and CEO of Poseida Therapeutics, emphasized the importance of the acquisition:
“Poseida has demonstrated the unique ability of its non-viral platform to deliver TSCM-rich CAR-T therapies with the potential to improve clinical outcomes and expand access. Joining Roche will allow us to accelerate development and bring our therapies to patients worldwide.”

The transaction terms include a tender offer for all outstanding Poseida shares, priced at $9.00 per share in cash at closing. The CVR, valued at up to $4.00 per share, will be contingent upon achieving specific clinical, regulatory, and commercial milestones. Roche plans to acquire any remaining shares not tendered during the initial offer through a second-step merger, ensuring full ownership of Poseida.

The deal is expected to close in the first quarter of 2025, subject to regulatory approvals and customary closing conditions. Centerview Partners LLC and Cooley LLP advised Poseida on the transaction, while Citi and Sidley Austin LLP served as advisors to Roche.

This acquisition represents a major milestone for Poseida and Roche alike. For Roche, it establishes a new core capability in allogeneic cell therapy and genetic medicine, areas that hold immense promise for the future of personalized healthcare. For Poseida, the merger offers an opportunity to leverage Roche’s global resources in late-stage development, commercialization, and market access, enabling its therapies to reach patients worldwide.

As the biotech industry increasingly focuses on transformative therapies, this deal underscores the growing importance of partnerships in accelerating innovation. With Poseida’s cutting-edge technology and Roche’s global expertise, the acquisition is poised to reshape the landscape of cell and genetic therapies, delivering groundbreaking treatments to patients across the globe.

Release – Cadrenal Therapeutics Named Anticoagulation Therapy Company of the Year by Pharma Tech Outlook

Posted on November 19, 2024November 19, 2024 by aweinsoff@channelchek.com

Research News and Market Data on CVKD

Recognized as innovative biopharma developing a potentially safer and superior anticoagulant for patients with implanted cardiac devices and rare cardiovascular conditions

PONTE VEDRA, Fla., Nov. 19, 2024 — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) anticoagulant, has been recognized as the 2024 “Anticoagulation Therapy Company of the Year” by Pharma Tech Outlook, an industry publication focused on breakthrough pharmaceutical technologies. The award underscores Cadrenal’s commitment to addressing the significant unmet needs of patients with implanted left ventricular assist devices (LVADs) and other rare cardiovascular conditions who require chronic anticoagulation. Cadrenal aims to develop a better VKA blood thinner for these warfarin-dependent patients.

In addition to receiving the award, Cadrenal was featured in the current edition of Pharma Tech Outlook. Entitled Pioneering Innovation in Anticoagulation for Rare Cardiovascular Conditions, the article highlights tecarfarin, Cadrenal’s lead candidate that is being developed to potentially overcome many of the challenges associated with warfarin anticoagulation therapy including drug-drug interactions and wide variability requiring frequent dosing changes. Unlike VKA warfarin, tecarfarin uses a unique metabolic pathway that is less affected by drug-drug interactions and kidney impairment. By providing a stable, once-daily, and reversible therapeutic, Cadrenal seeks to improve patient outcomes and ease the burden on patients and healthcare providers who face the complex anticoagulation management needs of this population.

“We are honored to receive this recognition from Pharma Tech Outlook,” said Quang X. Pham, founder and CEO of Cadrenal Therapeutics. “Our goal is to provide a safer and superior blood thinner option for patients who rely on chronic anticoagulation but are underserved by current treatments. Warfarin, the first VKA anticoagulant, was approved more than 70 years ago yet no significant advancements in oral VKA drugs have occurred since then.”

“Cadrenal Therapeutics has demonstrated a commitment to filling a serious gap in anticoagulation therapy,” said Lisa Winget, Managing Editor at Pharma Tech Outlook. “We are pleased to recognize Cadrenal’s innovative approach to developing a new treatment to serve patients with LVADs and other rare cardiovascular conditions.”

With orphan drug and fast-track designations, tecarfarin is uniquely positioned to fill the gap in chronic anticoagulation treatment options for patients with LVADs and rare cardiovascular conditions such as end-stage kidney disease (ESKD) with atrial fibrillation.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics is a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) to provide potentially safer and superior chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions. Cadrenal is focused on evaluating tecarfarin versus warfarin in reducing adverse events such as strokes, heart attacks, and bleeds in these patients. With tecarfarin, Cadrenal aims to address many of warfarin’s challenges such as drug interactions, frequent dosing adjustments, and kidney impairment effects, which are common in these patients. Tecarfarin has an orphan drug designation for left ventricular assist device (LVAD) patients and both orphan drug and fast-track designations for end-stage kidney disease patients with atrial fibrillation. Cadrenal is advancing a pivotal trial and pursuing clinical and commercial partnerships, with plans to study mechanical heart valve patients facing anticoagulation difficulties. Visit www.cadrenal.com to learn more.

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.” These statements include statements regarding Cadrenal’s anticoagulant being a potentially safer and superior anticoagulant for patients with implanted cardiac devices and rare cardiovascular conditions; Cadrenal developing a better VKA blood thinner for warfarin-dependent patients; Cadrenal’s lead candidate potentially overcoming many of the challenges associated with warfarin anticoagulation therapy including drug-drug interactions and wide variability requiring frequent dosing changes; Cadrenal improving patient outcomes and easing the burden on patients and healthcare providers who face the complex anticoagulation management needs of this population; Cadrenal providing a safer and superior blood thinner option for patients who rely on chronic anticoagulation but are underserved by current treatments; and tecarfarin being uniquely positioned to fill the gap in chronic anticoagulation treatment options for patients with LVADs and rare cardiovascular conditions such as end-stage kidney disease (ESKD) with atrial fibrillation; and advancing a pivotal trial and pursuing clinical and commercial partnerships, with plans to study mechanical heart valve patients facing anticoagulation difficulties. 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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to be a safer and superior anticoagulant for patients with implanted cardiac devices and rare cardiovascular conditions and being a better VKA blood thinner for warfarin-dependent patients, the ability of the Company to advance tecarfarin in a pivotal trial and to advance tecarfarin with patients with LVADs and those with AFib and ESKD, the ability to advance commercial partnerships 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.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

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SOURCE Cadrenal Therapeutics, Inc.

Release – Tonix Pharmaceuticals Announces Poster Presentation at the American College of Rheumatology (ACR) Convergence 2024 Annual Meeting

Posted on November 13, 2024November 13, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

November 13, 2024 4:05pm ESTDownload as PDF

CHATHAM, N.J., Nov. 13, 2024 (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 Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will deliver a poster presentation at the ACR Convergence 2024 Annual Meeting, which will be held in Washington, D.C., November 14-19, 2024. A copy of the Company’s presentation will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the ACR website here.

Presentation Details

Presenter:	Seth Lederman, M.D.

Title:	Randomized, Double-Blind, Placebo-Controlled Confirmatory Phase 3 Trial of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) in Fibromyalgia

Poster No.:	1218

Session:	Poster Session B, Pain in Rheumatic Disease Including Fibromyalgia Poster

Location:	Walter E. Washington Convention Center, Washington, D.C.

Date:	Sunday, November 17, 2024

Time:	10:30 a.m. – 12:30 p.m. ET

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. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. We expect an FDA decision on the acceptance of the NDA for review and a PDUFA date in December and if accepted, a decision on NDA approval in 2025. 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 of Drug Abuse and Addiction. 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 areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and 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 Toni’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 Toni’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

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

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

Media Contact

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

Source: Tonix Pharmaceuticals Holding Corp.

Released November 13, 2024

Release – Cadrenal Therapeutics Highlights Presentation at European Association For Cardio-Thoracic Surgery (EACTS) Medical Congress

Posted on November 12, 2024November 12, 2024 by aweinsoff@channelchek.com

Research News and Market Data on CVKD

Leading heart failure specialist features tecarfarin data and Cadrenal’s proposed clinical trial protocol at 8th EACTS Mechanical Circulatory Support Summit

PONTE VEDRA, Fla., Nov. 12, 2024 — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) anticoagulant, today highlighted a key opinion leader presentation at the November 2024 European Association for Cardio-thoracic Surgery (EACTS) Mechanical Circulatory Support Summit that featured tecarfarin historical data and Cadrenal’s proposed clinical trial protocol to evaluate tecarfarin versus warfarin in patients with the Abbott HeartMate3 (HM3) left ventricular assist device (LVAD).

The presentation, titled Tecarfarin and Hemocompatibility with LVAD Therapy (TECH-LVAD), took place in Prague, Czech Republic and outlined Cadrenal’s proposed clinical trial protocol recently submitted to the U.S. Food and Drug (FDA). Dr. Mandeep R. Mehra, who holds the William Harvey Chair in Advanced Cardiovascular Medicine and is Executive Director, Center for Advanced Heart Disease, Brigham and Women’s Hospital, developed and delivered the TECH-LVAD presentation. In the presentation Dr. Mehra highlighted data from past trials demonstrating the inverse relationship between bleeding rates and time in therapeutic range (TTR) for HM3 patients, and evidence from prior studies indicating tecarfarin’s potential ability to improve TTR. He included data from a trial in end-stage kidney disease (ESKD) patients showing that ESKD does not alter tecarfarin exposure while warfarin exposure is increased, explaining that this is one of the critical differentiators for tecarfarin because many LVAD patients have kidney impairment.

Dr. Mehra, who also chaired Abbott’s ARIES-HM3 study in LVAD patients and is a Professor of Medicine, Harvard University, commented, “In the proposed TECH-LVAD trial, we plan to study a much-needed VKA option with the expectation of reducing bleeding events that accompany use of the HM3 LVAD in advanced heart failure. Tecarfarin could potentially be an important therapy for patients with LVADs who all require chronic anticoagulation.”

“As our team progresses discussions with the FDA and Abbott about a tecarfarin study in LVAD patients, increasing tecarfarin data visibility will help us to continue accelerating our development as we plan for investigator outreach and patient recruitment for our tecarfarin trial,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics.

ABOUT CADRENAL THERAPEUTICS, INC.

Cadrenal Therapeutics is a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to offer safer, more effective chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions. Tecarfarin is anticipated to result in fewer adverse events such as strokes, heart attacks, bleeds, and deaths than warfarin, the most commonly used anticoagulant for these patients, despite its prevalent adverse events, drug-to-drug interactions, and frequent dosing changes. Cadrenal is focused on evaluating tecarfarin’s superiority to warfarin in these patients where direct oral anticoagulants (DOACs) are not recommended in the treatment guidelines of leading cardiology associations. Tecarfarin received an orphan drug designation for advanced heart failure patients with implanted left ventricular assist devices (LVADs) as well as both orphan drug and fast-track status for end-stage kidney disease patients with atrial fibrillation. Cadrenal is opportunistically planning pivotal clinical trials and pursuing clinical and commercial partnerships to advance tecarfarin. The company’s plans also include studying tecarfarin in patients with mechanical heart valves experiencing anticoagulation difficulties. Visit www.cadrenal.com to learn more.

Safe Harbor Statement

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.” These statements include statements regarding our planned pivotal trial to evaluate tecarfarin’s effectiveness for LVAD patients, tecarfarin’s potential ability to improve TTR; the plan to study a much-needed VKA option with the expectation to reduce bleeding events that accompany use of the HM3 LVAD in advanced heart failure; tecarfarin potentially being an important therapy for patients with LVADs who all require chronic anticoagulation and advancing the visibility of tecarfarin data helping to continue to accelerate the Company’s development as it plans for investigator outreach and patient recruitment for its tecarfarin trial. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to improve TTR and anticoagulation treatment in patients, the ability of the Company to advance tecarfarin with patients with left ventricular assist devices (LVADs) and those with ESKD with AFib, the collaborative efforts with Abbott being successful 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.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

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SOURCE Cadrenal Therapeutics, Inc.

Release – Tonix Pharmaceuticals Reports Third Quarter 2024 Financial Results and Operational Highlights

Posted on November 12, 2024November 12, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

November 12, 2024 8:00am EST Download as PDF

Release – Cadrenal Therapeutics Provides Third-Quarter Corporate Update

Posted on November 7, 2024November 7, 2024 by aweinsoff@channelchek.com

Research News and Market Data on CVKD

PONTE VEDRA, Fla., Nov. 7, 2024 — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD) (the “Company” or “Cadrenal”), a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to provide safer and superior anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions, today provided a corporate update coinciding with the filing of its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024.

Recent Highlights

In early September, Cadrenal leadership met with the U.S. Food and Drug Administration (FDA) to discuss its tecarfarin Phase 3 clinical trial protocol in left ventricular assist device (LVAD) patients and is continuing these discussions.
Cadrenal advanced Abbott collaboration discussions regarding Cadrenal’s pivotal clinical trial in patients with the Abbott LVAD HeartMate 3, the only LVAD available in the U.S.
Also, in October 2024, Cadrenal joined the Corporate Council of the Anticoagulation Forum (AC Forum), the largest professional organization of anticoagulation specialists committed to advancing the quality and safety of chronic anticoagulation care globally. Through participation in the Corporate Council, Cadrenal will collaborate with the AC Forum as it works to educate and engage the organization’s 15,000 healthcare professional members to improve outcomes for patients on anticoagulants.
Cadrenal and its pharmaceutical contract development and manufacturing organization (CDMO) completed the operational readiness activities necessary to supply active pharmaceutical ingredients and clinical trial materials in accordance with current good manufacturing principles (cGMP).
On October 24, 2024, Cadrenal announced that it successfully raised approximately $5.1 million through its at-the-market facility (ATM).
On November 1, 2024, Cadrenal announced the exercise of warrants generating gross proceeds of approximately $4.7 million.
Recent financing transactions totaling $9.8 million increased its cash balance to approximately $11.3 million and strengthened its balance sheet. The net proceeds provide Cadrenal with additional working capital as it advances tecarfarin toward a pivotal Phase 3 trial.
Q3 2024 operating expenses were $2.5 million, including $0.3 million of non-cash expenses.
Cash used in operating activities totaled $2.2 million during Q3 2024.
Cash and cash equivalent balance of $11.3 million as of November 7, 2024.

“Momentum is building from our achievement of several critical milestones toward beginning a pivotal clinical trial to evaluate tecarfarin’s superiority to warfarin in LVAD patients,” said Quang X. Pham, Founder, Chairman, and Chief Executive Officer of Cadrenal Therapeutics. “These accomplishments span finance, operations, partner relations, and clinical development and enhance our ability to execute our strategic plan going into 2025.

“Efficiently raising nearly $10 million in recent weeks bolsters funds for operational and clinical development needs. At the same time, we are progressing our dialogue with the FDA and Abbott and moving ahead with our CDMO to manufacture tecarfarin for our Phase 3 trial,” continued Pham.

Tecarfarin is the only anticoagulant in development worldwide for patients with implanted cardiac devices and other rare cardiovascular conditions. The oral and reversible drug has been uniquely designed to overcome many of the challenges patients experience with warfarin and to fill a need unmet by direct oral anticoagulants (DOACs) that are contraindicated or not recommended by leading cardiology associations for these individuals. If approved, tecarfarin may be a safer and more effective chronic anticoagulant for LVAD patients in the U.S.

In addition, tecarfarin may prove valuable for other patients where warfarin is not providing recommended anticoagulation because of genetic warfarin resistance or renal impairment making warfarin metabolism difficult. These include individuals with end-stage renal disease and atrial fibrillation or those with mechanical heart valves and hard-to-control anticoagulation, as determined by International Normalized Ratio (INR) measurements of how long it takes the blood to clot.

ABOUT CADRENAL THERAPEUTICS, INC.

Cadrenal Therapeutics is a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to offer safer, more effective chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions. Tecarfarin is anticipated to result in fewer adverse events such as strokes, heart attacks, bleeds, and deaths than warfarin, the most commonly used anticoagulant for these patients, despite its prevalent adverse events, drug-to-drug interactions, and frequent dosing changes. Cadrenal is focused on evaluating tecarfarin’s superiority to warfarin in these patients where DOACs are not recommended in the treatment guidelines of leading cardiology associations. Tecarfarin received an orphan drug designation for advanced heart failure patients with implanted LVADs as well as both orphan drug and fast-track status for end-stage kidney disease patients with atrial fibrillation. Cadrenal is opportunistically planning pivotal clinical trials and pursuing clinical and commercial partnerships to advance tecarfarin. The company’s plans also include studying tecarfarin in patients with mechanical heart valves experiencing anticoagulation difficulties. Visit www.cadrenal.com to learn more.

About Tecarfarin

Tecarfarin is a Phase 3-ready drug candidate that Cadrenal is developing to overcome many of warfarin’s challenges and fill the need for a safer and more effective VKA chronic anticoagulant. Tecarfarin is anticipated to improve outcomes and result in fewer major events for warfarin-dependent patients. Extensive data indicates that the efficacy of tecarfarin, metabolized via a different pathway than warfarin, is not affected by drug-drug interactions and kidney impairment, which are common in these patients. Phase 2/3 clinical trials show that tecarfarin may offer enhanced stability and time in therapeutic range (TTR) that inversely correlate with major events. Tecarfarin is the only new anticoagulant being developed for patients with implanted cardiac devices or rare cardiovascular conditions. Treatment with tecarfarin aims to improve anticoagulation for these underserved patients and their healthcare providers who face difficulties in managing warfarin’s wide variability and risk of gastrointestinal bleeds.

Safe Harbor Statement

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.” These statements include statements regarding our planned pivotal trial to evaluate tecarfarin’s effectiveness for LVAD patients, the success of the Company’s collaborative efforts with Abbott, tecarfarin potentially being a safer and more effective chronic anticoagulant for patients with LVADs, tecarfarin filling a need unmet by DOACs that are contraindicated or not recommended, the commencement of trials to evaluate tecarfarin’s superiority to warfarin in LVAD patients and potentially bring the Company’s better anticoagulation solution to those in need, and tecarfarin proving valuable for other patients where warfarin is not providing recommended anticoagulation because of genetic warfarin resistance or renal impairment making warfarin metabolism difficult. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to improve anticoagulation treatment in patients, the ability of the Company to advance tecarfarin with patients with left ventricular assist devices (LVADs), the collaborative efforts with Abbott being successful and those with AFib and ESKD, the collaboration with Abbott being successful 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.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

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SOURCE Cadrenal Therapeutics, Inc.

Avid Bioservices to be Acquired by GHO Capital and Ampersand in $1.1 Billion Deal

Posted on November 7, 2024November 7, 2024 by slightbourne@noblecapitalmarkets.com

Key Points:
– Avid Bioservices will be acquired by GHO Capital and Ampersand Capital in a $1.1 billion deal, with a 13.8% per-share premium.
– Acquisition to enhance Avid’s biologics CDMO services with expanded resources for development and manufacturing.
– Expected to close in Q1 2025, enabling Avid to operate privately and accelerate its service offerings for the biotechnology sector.

Avid Bioservices, Inc. (NASDAQ: CDMO), a major biologics contract development and manufacturing organization (CDMO), announced its acquisition by GHO Capital Partners LLP and Ampersand Capital Partners for approximately $1.1 billion. The all-cash transaction positions Avid for substantial growth, with the backing of experienced healthcare-focused investors to expand its development and manufacturing capabilities in the biotechnology sector. This acquisition marks a strategic move for GHO and Ampersand, leveraging Avid’s expertise to strengthen their portfolios in the life sciences industry.

Under the agreement terms, GHO and Ampersand will acquire Avid’s outstanding shares for $12.50 each in cash, reflecting a 13.8% premium over Avid’s closing share price and a 21.9% premium over its 20-day average. This values the transaction at $1.1 billion, enhancing Avid’s growth potential within a private company framework where it can develop its offerings with the support of dedicated capital and expanded industry networks.

Alan MacKay and Mike Mortimer, Managing Partners of GHO, expressed their excitement to work with Avid’s team to realize the company’s full potential, calling Avid “an ideal addition” that exemplifies their mission to improve healthcare access through efficient manufacturing and high-quality innovation. The deal will enable Avid to maintain its focus on serving the biotechnology and pharmaceutical sectors, helping it meet growing demand for complex biologics at clinical and commercial stages. Additionally, the acquisition aligns with GHO and Ampersand’s broader healthcare strategies, aiming to optimize Avid’s impact in global markets.

Nick Green, President and CEO of Avid, noted that partnering with GHO and Ampersand comes at an opportune time, as Avid has been strategically expanding to meet a broader range of customer needs. He emphasized that this partnership will further Avid’s impact, positioning it to better serve biopharma innovators by utilizing GHO and Ampersand’s resources. “After years of investment and expansion, now is the right time to move forward as a private company,” Green stated, expressing confidence that this move will significantly enhance Avid’s capabilities.

The acquisition is expected to support Avid’s future projects, including cell line development, CGMP clinical and commercial manufacturing, analytical testing, and expanded services for early-stage programs. This additional support allows Avid to optimize customer offerings, broaden its expertise, and develop new industry capabilities that align with its dedication to quality and regulatory standards.

The acquisition, unanimously approved by Avid’s board of directors, is expected to close in Q1 2025, pending customary approvals. Avid’s shares will no longer be publicly traded after the acquisition, and the company will continue to operate under its current name and brand identity, with its headquarters remaining in Tustin, California. Financial and legal advising for Avid are being handled by Moelis & Company LLC and Cooley LLP, respectively, while GHO and Ampersand are advised by William Blair & Company and Ropes & Gray LLP.

This partnership reflects GHO and Ampersand’s strategic investment approach, enabling Avid to strengthen its leadership in biologics manufacturing and develop solutions that respond to high-growth demand in the industry.

Release – Tonix Pharmaceuticals Announces Research Agreement with Kenya Medical Research Institute (KEMRI) to Design, Plan and Seek Regulatory Approval for a Phase I Clinical Study of TNX-801 for Mpox in Kenya

Posted on November 4, 2024November 4, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

November 04, 2024 7:00am EST Download as PDF

Proposed clinical study in Kenya intended to test the safety, tolerability, and immunogenicity of TNX-801, a vaccine being developed to prevent mpox (formerly called monkeypox)

The World Health Organization (WHO) declared mpox a public health emergency of international concern (PHEIC) ^1-4: cases of the new Clade Ib mpox detected in Sweden, Thailand, Singapore, India, Germany and England

In preclinical data, TNX-801, Tonix’s attenuated live-virus vaccine candidate, demonstrated efficacy as a vaccination against mpox in animal models

CHATHAM, N.J., Nov. 04, 2024 (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 has entered into a sponsored research agreement with the Kenya Medical Research Institute (KEMRI) to design, plan and seek regulatory approval for a Phase I clinical study in Kenya to test the safety, tolerability, and immunogenicity of TNX-801 (horsepox, live virus) as a vaccine to prevent mpox and smallpox. Tonix will be the sponsor and KEMRI will lead the execution of the proposed clinical trial.

“We are excited to advance development of TNX-801 under this research agreement with KEMRI,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “There is an urgent need for the worldwide availability of a single dose mpox vaccine with durable protection. TNX-801 has demonstrated encouraging preclinical data and was recently shown to align with the World Health Organization’s (WHO’s) newly issued preferred target product profile (TPP) for mpox vaccines. Further, TNX-801 can be scaled up for manufacturing, distribution and storage without a costly supply chain. We believe TNX-801 has the potential to address and help interrupt the spread of mpox worldwide.”

In September 2024, Tonix announced that the preferred target product profile (TPP), released at the WHO sponsored Mpox Research and Innovation Scientific Conference, aligns with the potential characteristics of TNX-801. Key elements of the WHO draft TPP include single-dose, durable protection, administration without special equipment, and stability at ambient temperature. Other potential beneficial characteristics include the ability to limit forward transmission, use in case-contact vaccination strategies and suitability for use in immunocompromised individuals.

In August 2024, Tonix announced a collaboration with Bilthoven Biologics (Bbio) to develop GMP manufacturing processes for TNX-801. Bbio is part of the world’s largest vaccine manufacturer, the Cyrus Poonawalla Group, which also includes the Serum Institute of India.

About TNX-801^*

TNX-801 is a live minimally-replicating attenuated horsepox vaccine that is believed to provide immune protection against mpox in animals with better tolerability than 20^th century vaccinia viruses. Vaccinia vaccines from the 20^th century are descendants of Edward Jenner’s circa 1800 that have become more virulent in connection with losing regulatory elements in their genomes. Given the modern understanding that Jenner’s circa 1800 vaccine would be called “horsepox” today, TNX-801 was designed to be similar to Jenner’s vaccine. After a single dose vaccination, TNX-801 protected animals against lethal challenge with intratracheal Clade Ia monkeypox virus.⁵ In this experiment, TNX-801 vaccination prevented clinical disease and skin lesions and also decreased shedding in the mouth and lungs. The findings are consistent with mucosal immunity and suggest the ability to block forward transmission. In addition, TNX-801 has decreased virulence in immunocompromised animals relative to 20^th Century vaccinia viruses.⁶ Based on animal studies, TNX-801 combines immune protection with improved tolerability compared to live-virus vaccinia vaccines. TNX-801 is administered with a single dose which has advantages over two-dose regimens. The focus on single-dose vaccines confirms early recommendations by the Bipartisan Commission on Biodefense,⁷ and the U.S. National Academies of Science.^7,8 The National Academies of Science (NAS) report highlights the difficulty of a ring vaccination strategy with even a two-dose regimen.⁷ TNX-1800 is an engineered version of horsepox that expresses the spike protein of SARS-CoV-2.^9,10 The U.S. National Institutes of Health (NIH) selected Tonix’s COVID-19 vaccine, TNX-1800 for Project NextGen.

About Mpox^*
On August 14, 2024, the WHO determined that the upsurge of mpox in a growing number of countries in Africa constitutes a PHEIC, the second such declaration in the past two years called in response to an mpox outbreak.¹ The current outbreak is caused by Clade Ib monkeypox virus while the 2022 outbreak was caused by Clade IIb monkeypox virus. The 2022 global mpox outbreak, which is ongoing, has affected over 90,000 persons in countries where mpox had previously not been endemic, including Europe and the US. The rapid spread of Clade IIb strain mpox in 2022 underscores the pandemic potential of mpox. Unlike Clade IIb mpox, the Clade Ib strain of mpox appears to be spreading in Africa, particularly those neighboring the Democratic Republic of the Congo, including Burundi, Rwanda, and Uganda, but now affecting 16 countries. According to the U.S. Centers for Disease Control and Prevention (CDC), and other experts, there is a significant risk that the Clade Ib monkeypox may appear in the U.S.^2,3

Tonix Pharmaceuticals Holding Corp.^*
Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to progress TNX-102 SL, a product candidate for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia. The FDA has 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 Institude of Drug Abuse and Addiction. 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 areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix has 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.

¹WHO Press Release August 14, 2024. “WHO Director-General declares mpox outbrfeak a public health emergency of international concern”. URL: www.who.int/news/item/14-08-2024-who-director-general-declares-mpox-outbreak-a-public-health-emergency-of-international-concern (accessed 8-15-24)
²McQuiston JH, et al. U.S. Preparedness and Response to Increasing Clade I Mpox Cases in the Democratic Republic of the Congo. 2024, MMWR Morbi Mortal Wkly Rep: United States. p. 435-440
³CDC. 2022-2023 Mpox: US Map and Case Count. https://www.cdc.gov/poxvirus/mpox/response/2022/us-map.html
⁴World Health Organization SAGE meeting highlights on updated mpox vaccine recommendations. 2024, March
⁵Noyce RS, et al. Viruses. 2023 Jan 26;15(2):356. Doi: 10.3390/v15020356. PMID: 36851570; PMCID: PMC9965234
⁶Trefry, SV et al. bioRxiv 2023.10.25.564033; doi: https://doi.org/10.1101/2023.10.25.564033
⁷Bipartisan Commission on Biodefense. Box the Pox: Reducing the risk of Smallpox and Other Ortho poxviruses, Washington:2024
⁸U.S. National Academies of Science. Future State of Smallpox Medical Countermeasures. Washington:2024
⁹Awasthi M, et al. Viruses. 2023 Oct 21;15(10):2131. Doi: 10.3390/v15102131. PMID: 37896908; PMCID: PMC10612059.
¹⁰Awasthi M et al Vaccines (Basel). 2023 Nov 2;11(11):1682. Doi: 10.3390/vaccines11111682.PMID: 38006014

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 Toni’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 Toni’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

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

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

Media Contact

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

Source: Tonix Pharmaceuticals Holding Corp.

Released November 4, 2024

Release – Cocrystal Pharma’s Co-CEOs Highlight Pioneering Approach to Antiviral Drug Candidates Targeting Influenza and Coronaviruses as Fall Flu and COVID Season Begins

Posted on October 31, 2024October 31, 2024 by aweinsoff@channelchek.com

Research News and Market Data on COCP

October 31, 2024

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The Company’s antiviral candidate for seasonal and pandemic influenza shows in vitro activity against the avian influenza A PB2 protein, whereas current influenza vaccines offer no protection against pandemic avian influenza

BOTHELL, Wash., Oct. 31, 2024 (GLOBE NEWSWIRE) — As the fall seasonal influenza and COVID season gets underway in the Northern Hemisphere, Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) highlights the ability of the Company’s innovative structure-based drug discovery platform technology to discover and develop novel broad-spectrum antivirals therapeutics to treat a wide range of viral diseases, including newly emerging pandemic strains such as recent H5N1 avian influenza identified in the US.

“As our nation enters the fall flu and COVID season and learns of the emerging highly pathogenic avian H5N1 influenza A strain in dairy cattle and humans, the need for more effective antivirals is clear. Current flu vaccines are developed for seasonal influenza strains, not for pandemic avian influenza strains. Also, treatment-emergent resistance to approved antivirals and transmission of resistant viruses has been a challenging issue,” said Sam Lee, PhD, President and co-CEO of Cocrystal. “For example, the widespread oseltamivir (Tamiflu®) resistance of the pandemic avian influenza strains could create a serous public health situation. Clearly, there continues to be an unmet need for therapeutics with a high barrier to resistance.

“We believe our approach makes it possible to develop highly effective therapeutics for noroviruses, coronaviruses and influenza A because we target the highly conserved, essential function of viral enzymes, regardless of whether the strain is seasonal or pandemic,” he added. “We recently revealed the high-resolution cocrystal structure of the avian influenza PB2 protein complexed with CC-42344, further confirming that our PB2 inhibitor CC-42344 binds to its highly conserved PB2 region, indicating activity against this strain.”

Cocrystal’s platform utilizes Nobel Prize-winning technology to develop a new class of direct-acting antivirals that work against enzymes that are essential for viral replication. The Company is evaluating its oral CC-42344 in a Phase 2a study in healthy subjects infected with a seasonal influenza A strain. Topline safety and tolerability results from this trial are expected by the end of 2024, and preparations are underway for an Investigational New Drug (IND) application to conduct a late-stage clinical study with CC-42344 in the U.S.

The Company is also conducting a Phase 1 study with its oral protease inhibitor CDI-988, the first pan-viral drug candidate in clinical evaluation for both noroviruses and coronaviruses. Topline safety and tolerability results of the multiple-ascending cohorts are expected late this year or early next year. There is no approved vaccine or antiviral for norovirus. Norovirus is highly contagious and is the most common cause of acute gastroenteritis, which has gained notoriety for outbreaks in closed quarters such as on cruise ships and in nursing homes. According to the Centers for Disease Control and Prevention (CDC), an estimated 685 million cases and an estimated 200,000 deaths are attributed to norovirus each year worldwide, with an estimated societal cost of approximately $60 billion.

“We view the next viral pandemic as a question of timing as seasonal viruses like flu and COVID continue to evolve,” said James Martin, CFO and co-CEO of Cocrystal. “Our proprietary technology platform allows us to efficiently discover and develop potent, broad-spectrum, effective antiviral drug candidates for pandemic and seasonal outbreaks relatively quickly and far less costly than traditional approaches to drug development. As a small company, Cocrystal is highly efficient in utilizing our groundbreaking technology to develop differentiated antivirals for high-value indications with the goal of improving people’s lives.”

Avian Influenza
A multistate outbreak of highly pathogenic avian influenza in dairy cows was initially reported in March 2024. This is the first time that avian flu viruses were found in cows, with outbreaks now confirmed in herds in 14 states. In April 2024 the CDC confirmed an avian flu infection in a person exposed to dairy cows that were presumed to be infected with the virus. This is believed to be the first instance of likely mammal to human spread of this virus. In September 2024 the CDC reported the first human case of avian influenza without a known occupational exposure to sick or infected animals. As of October 30, 2024, the CDC has reported 36 human cases of this highly pathogenic avian influenza A in the U.S. during 2024.

The CDC analyzed blood collected from people of all ages in all 10 Health & Human Services regions during the 2022-2023 and 2021-2022 flu seasons. These samples were challenged with the avian flu subtype H5N1 virus to determine whether there was an antibody reaction. Data from this study suggest that there is extremely low to no population immunity to clade 2.3.4.4b A (H5N1) viruses in the U.S. Antibody levels remained low regardless of whether or not participants received a seasonal flu vaccination, meaning that seasonal flu vaccination did not produce antibodies to avian flu H5N1 viruses.

Antiviral Influenza Candidate CC-42344
CC-42344 is Cocrystal’s novel, broad-spectrum investigational antiviral candidate for the treatment of pandemic and seasonal influenza A. CC-42344 inhibits the first step in influenza A’s viral replication by binding to a highly conserved PB2 site of the influenza polymerase complex that is essential to replication and was discovered using Cocrystal’s proprietary structure-based drug discovery platform technology.

Cocrystal is evaluating safety, viral and clinical measures of oral CC-42344 in healthy volunteers who are challenged with influenza A in a Phase 2a human challenge study underway in the United Kingdom. CC-42344 was advanced into this study following favorable safety and tolerability results reported in a Phase 1 study in healthy volunteers conducted in Australia. In vitro testing showed CC-42344’s excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to Tamiflu® and Xofluza®, while also demonstrating favorable pharmacokinetic and safety profiles.

Cocrystal used its structure-based platform to determine the high resolution X-ray crystal structure of the recent avian influenza A (H5N1) PB2 protein, and confirmed activity of CC-42344 in vitro (NIH GeneBank ID:influenza A/Texas/37/2024(H5N1). The crystal structure of the avian influenza A (H5N1) PB2 protein showed new mutations located outside the PB2 active site. Subsequent studies showed that CC-42344 binds to the active site of the avian influenza A (H5N1) PB2 protein as previously demonstrated with the pandemic and seasonal influenza A PB2.

Structure-Based Platform Technology
Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps to identify novel binding sites and allows for a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of best-in-class antiviral therapies that have fast onset of action and/or shortened treatment time, are safe, well tolerated and easy to administer, are effective against all viral subtypes that cause disease and have a high barrier to viral resistance.

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

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential efficacy of Cocrystal’s product candidates against certain viruses, ongoing research and development efforts including the expected timing of clinical studies and topline results for such product candidates, and the potential market for such product candidates. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to our ability to obtain regulatory authority for and proceed with clinical trials including the recruiting of volunteers for such studies by our clinical research organizations and vendors, the results of such studies, our collaboration partners’ technology and software performing as expected, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, and potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

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

# # #

Source: Cocrystal Pharma, Inc.

Released October 31, 2024

Release – Cadrenal Therapeutics Joins Corporate Council Of Anticoagulation Forum

Posted on October 23, 2024October 23, 2024 by aweinsoff@channelchek.com

Research News and Market Data on CVKD

Participation Reinforces Cadrenal’s Commitment to Innovation, Education and Improved Patient Outcomes with Anticoagulation Therapy

PONTE VEDRA, Fla., Oct. 23, 2024 — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to improve anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions, today announced its membership in the Corporate Council of the Anticoagulation Forum (AC Forum).

The AC Forum is the largest professional organization of anticoagulation specialists, committed to advancing the quality and safety of chronic anticoagulation care globally. Through participation in the Corporate Council, Cadrenal Therapeutics will collaborate with the AC Forum as it works to identify and address unmet clinical needs, share cutting-edge research, and promote advocacy and educational initiatives for the organization’s 15,000 healthcare professional members aimed at improving outcomes for patients on anticoagulants.

“Our membership in the AC Forum’s Corporate Council reflects our shared commitment to transforming anticoagulation care,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “We look forward to partnering with the AC Forum and contributing to programs that advance safer, more effective care and inform about ongoing research and anticoagulation best practice guidelines.”

Darren Triller, PharmD, Director of Strategic Initiatives at the Anticoagulation Forum, welcomed Cadrenal Therapeutics to the Corporate Council, saying: “We are excited to have Cadrenal Therapeutics join us in our mission to improve the quality of care for patients receiving antithrombotic therapies. We look forward to a productive partnership that will help us address the challenges in the anticoagulation landscape together.”

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics is a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to offer safer, superior chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions. Tecarfarin is anticipated to result in fewer adverse events such as strokes, heart attacks, bleeds and deaths than warfarin, the most commonly used anticoagulant for these patients despite its prevalent side effects, drug-to-drug interactions and frequent dosing changes. Tecarfarin received an orphan drug designation for advanced heart failure patients with implanted left ventricular assist devices (LVADs) as well as both orphan drug and fast-track status for end-stage kidney disease patients with atrial fibrillation. Cadrenal is planning pivotal clinical trials and pursuing clinical and commercial partnerships. The company’s plans also include studying tecarfarin in patients with mechanical heart valves experiencing anticoagulation difficulties. Visit www.cadrenal.com to learn more.

About the Anticoagulation Forum

The Anticoagulation Forum has led advancements in thrombosis-related care for over three decades. With more than 15,000 members across 3,000 healthcare institutions, the AC Forum is dedicated to enhancing the safety and quality of care for over 1 million patients annually. Through education, thought leadership, and partnerships with industry leaders, the AC Forum shapes the future of anticoagulation management to ensure the best outcomes for patients.

For more information, please contact:
Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

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SOURCE Cadrenal Therapeutics, Inc.

Release – Tonix Pharmaceuticals Receives First Contract Payment from U.S. Department of Defense for Accelerated Development of Broad-Spectrum Antivirals with the Defense Threat Reduction Agency (DTRA)

Posted on October 17, 2024October 17, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

October 17, 2024 8:00am EDT Download as PDF

First payment received under Tonix’s contract with the Defense Threat Reduction Agency (DTRA), for up to $34 million over five years

CHATHAM, N.J., Oct. 17, 2024 (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, received its first payment from the Defense Threat Reduction Agency (DTRA), an agency within the U.S. Department of Defense (DoD), to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. The previously announced award from DTRA is for up to $34 million over five years.

“This award provides important validation and substantial non-dilutive funding for our ongoing research to advance our antiviral discovery program,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals “With biological adaptations and mutations happening to viruses rapidly across the globe, this research will be crucial in order to protect lives in the event biological threats are introduced onto the battlefield.”

The $34.0 million five-year contract will help fund and accelerate the development of the Company’s broad-spectrum antiviral program, which has the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response. Tonix plans to leverage previous research on phosphatase inhibitors, specifically compounds that target CD45, to optimize lead compounds for therapeutic intervention of biothreat agents and provide the government with a complete and cost-effective solution for a broad-spectrum medical countermeasure. Tonix’s premise is that partial inhibition of CD45 will provide optimal antiviral protection while requiring lower plasma drug concentrations, a lower dose, and a better safety profile.

Tonix will utilize its state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab at its research and development center (RDC) facility located in Frederick, Md., as well as experienced personnel in-house. The RDC is located in Maryland’s ‘I-270 biotech corridor’ and is close to the center of the U.S. biodefense research community.

About Defense Threat Reduction Agency (DTRA)
The Defense Threat Reduction Agency (DTRA), an agency within the United States Department of Defense (DoD) is both a Defense Agency and Combat Support Agency with two distinct yet highly integrated roles countering Weapons of Mass Destruction (WMD) and emerging threats. Its origins stretch back to World War II and the Manhattan Project, but today the agency encompasses a wide variety of strategic and operational functions that deter, prevent, and ultimately prevail against these unique threats. DTRA enables the Department of Defense (DoD), the United States Government and international partners to counter and deter weapons of mass destruction (WMD) and emerging threats. DTRA provides cross-cutting solutions to enable the Department of Defense, the United States Government, and international partners to deter strategic attack against the United States and its allies; prevent, reduce, and counter WMD and emerging threats; and prevail against WMD-armed adversaries in crisis and conflict. DTRA’s continued effort to enhance the combat support mission also advances public health services by developing innovative technologies that protect against biological threats. For more information, visit www.dtra.mil.

Tonix Pharmaceuticals Holding Corp.^*^*Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to progress TNX-102 SL, a product candidate for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia. The FDA has 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 Institude of Drug Abuse and Addiction (NIDA). 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 areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and 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) 904-8182

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

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

Source: Tonix Pharmaceuticals Holding Corp.

Released October 17, 2024

Tag: Biopharmaceutical

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First payment received under Tonix’s contract with the Defense Threat Reduction Agency (DTRA), for up to $34 million over five years