SAN DIEGO, May 22, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced the pricing of its previously announced underwritten public offering of 2,222,222 shares of its common stock at a public offering price of $9.00 per share. In addition, Gyre has granted the underwriters of the offering an option for a period of 30 days to purchase up to an additional 333,333 shares of its common stock at the public offering price, less the underwriting discounts and commissions. The gross proceeds of the offering to Gyre, before deducting the underwriting discounts and commissions and other offering expenses payable by Gyre, are expected to be approximately $20.0 million. The offering is expected to close on or about May 27, 2025, subject to the satisfaction of customary closing conditions.
Jefferies is acting as lead book-running manager for the offering and H.C. Wainwright & Co. is acting as co-manager for the offering.
Gyre intends to use the net proceeds from this offering, together with its existing cash and cash equivalents and cash flows from operations, to advance its Phase 2 clinical trial of F351 in metabolic dysfunction-associated steatohepatitis (“MASH”)-associated liver fibrosis in the United States, for research and development, manufacturing and scale-up, as well as for working capital and general corporate purposes.
The shares of common stock described above are being offered pursuant to a shelf registration statement filed with the Securities and Exchange Commission (“SEC”) that was declared effective by the SEC on November 22, 2024. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website, located at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov and may also be obtained, when available, by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@jefferies.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: Gyre’s expectations regarding the consummation of the offering and the satisfaction of customary closing conditions with respect to the offering; and the expected use of net proceeds from the offering. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions relating to the offering; Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings Gyre may make with the SEC.
Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
Investor Contact: David Zhang Gyre Therapeutics david.zhang@gyretx.com
SAN DIEGO, May 22, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced that it has commenced an underwritten public offering of shares of its common stock. In addition, Gyre is expected to grant the underwriters of the offering an option for a period of 30 days to purchase additional shares of its common stock at the public offering price, less the underwriting discounts and commissions. The proposed public offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. All of the shares of common stock to be sold in the offering are being offered by Gyre.
Gyre intends to use the net proceeds from this offering, together with its existing cash and cash equivalents and cash flows from operations, to advance its Phase 2 clinical trial of F351 in metabolic dysfunction-associated steatohepatitis (“MASH”)-associated liver fibrosis in the United States, for research and development, manufacturing and scale-up, as well as for working capital and general corporate purposes.
Jefferies is acting as lead book-running manager for the offering and H.C. Wainwright & Co. is acting as co-manager for the offering.
The shares of common stock described above are being offered pursuant to a shelf registration statement filed with the Securities and Exchange Commission (“SEC”) that was declared effective by the SEC on November 22, 2024. The offering will be made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website, located at www.sec.gov. Prospective investors should read the preliminary prospectus supplement and the accompanying prospectus and other documents Gyre has filed with the SEC for more complete information about Gyre and the offering. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus related to the offering may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@jefferies.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: Gyre’s expectations regarding the offering, including the timing, size, structure and completion of the proposed offering on the anticipated terms; the grant to the underwriters of the option to purchase additional shares; and the expected use of net proceeds from the offering. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions relating to the offering; Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings Gyre may make with the SEC.
Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
Investor Contact: David Zhang Gyre Therapeutics david.zhang@gyretx.com
Achieved statistically significant ≥1-stage fibrosis regression at Week 52 vs. placebo (52.85% vs. 29.84%, P=0.0002).
Demonstrated favorable safety and tolerability profile: 4.88% serious adverse events vs. 6.45% for placebo; zero discontinuations due to adverse events.
Breakthrough Therapy Designation granted by China’s National Medical Products Administration (“NMPA”) in 2021 supports potential first-in-class approval in CHB-associated liver fibrosis (“CHB fibrosis”).
Gyre intends to seek accelerated approval for Hydronidone in CHB fibrosis, with a New Drug Application (“NDA”) submission to the NMPA expected in Q3 2025.
U.S. Phase 2 trial in MASH-associated liver fibrosis expected to begin in 2H2025.
SAN DIEGO, May 22, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced that its lead compound, Hydronidone (F351), met the primary endpoint in a pivotal Phase 3 trial evaluating its efficacy and safety for the treatment of liver fibrosis in patients with chronic hepatitis B (“CHB”) in China.
The 52-week, multicenter, double-blind, placebo-controlled trial enrolled 248 patients with CHB fibrosis across 39 hospitals in China. Patients were randomized 1:1 to receive either Hydronidone (270 mg/day, orally) or placebo, in addition to background entecavir antiviral therapy. The trial met its primary endpoint, with a statistically significant proportion of patients receiving Hydronidone achieving a ≥1-stage regression in liver fibrosis compared to placebo (P=0.0002). These results are consistent with the efficacy and safety outcomes observed in Gyre’s prior Phase 2 trial.
“These landmark Phase 3 results represent a major step forward for Gyre and for the millions of Chinese patients living with CHB fibrosis,” said Han Ying, Ph.D., CEO of Gyre Therapeutics. “Pending regulatory approval in China, Hydronidone may become the first therapy specifically indicated for reversing liver fibrosis in CHB patients and the foundation for broader expansion into metabolic dysfunction-associated steatohepatitis (“MASH”)-related fibrosis in the United States. We are deeply grateful to the patients and investigators who participated in this pivotal trial and made this important milestone possible.”
“The fibrosis regression in our trial marks a breakthrough in the treatment of CHB fibrosis,” said Prof. Lungen Lu, M.D., Dean of the Department of Gastroenterology at Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, and lead principal investigator. “With no approved anti-fibrotic therapies for this liver disease currently available, Hydronidone has the potential to transform the treatment landscape and offer new hope to patients facing the serious risks of cirrhosis, liver failure, and hepatocellular carcinoma.”
Hydronidone Week 52 Results
The efficacy analysis followed the intent-to-treat (“ITT”) principle. The ITT population comprised all randomized subjects who received at least one dose of study drug. One randomized subject who did not receive any treatment was excluded. All biopsies were independently reviewed by three blinded central pathologists to ensure consistency and objectivity of fibrosis and inflammation assessments.
Efficacy Results
In the ITT population, Hydronidone demonstrated statistically significant regression in liver fibrosis compared to placebo.
Primary Endpoint
Hydronidone 270mg N=123
Placebo N=124
P-value
≥1-stage fibrosis regression (Ishak)
52.85%
29.84%
P=0.0002
Key Secondary Endpoints
≥1-Grade inflammation improvement (Scheuer score) without progression of fibrosis
49.57%
34.82%
P=0.0246
Safety Results
Hydronidone was well tolerated, with a comparable incidence of serious adverse events (4.88% vs. 6.45% in the placebo group) and no discontinuations due to adverse events in either group. Most adverse events were mild or moderate and unrelated to Hydronidone, while a small number of severe adverse events occurred, none of which were considered related to the trial drug.
Our Path Forward
Gyre plans to submit primary results for publication in a peer-reviewed journal and present full trial results at a future medical congress.
Based on these positive results, Gyre plans to file an NDA with China’s NMPA in the third quarter of 2025. In parallel, the Company is actively preparing to file an investigational new drug (“IND”) application in the third quarter of 2025 and, subject to IND clearance, plans to initiate a Phase 2 trial in the U.S. evaluating Hydronidone for the treatment of MASH-associated fibrosis in the second half of 2025. A prior U.S. Phase 1 trial in healthy volunteers confirmed Hydronidone’s tolerability and demonstrated a pharmacokinetic profile consistent with the Chinese population.
About the Phase 3 Trial
The randomized, double-blind, placebo-controlled multicenter Phase 3 trial (NCT05115942) enrolled 248 patients with CHB fibrosis (Ishak fibrosis stage ≥3) across 39 hospitals in China. Patients were randomized 1:1 to receive either 270 mg Hydronidone or placebo daily, in combination with entecavir. The primary endpoint of the trial was the efficacy of fibrosis regression, defined as a decrease in the Ishak stage score of liver fibrosis ≥ 1 after 52 weeks of treatment compared to baseline. A key secondary endpoint was a ≥1-grade reduction in liver inflammation, as assessed by the Scheuer scoring system, after 52 weeks of treatment compared to baseline, without progression of fibrosis.
Patient Population for CHB-Associated Liver Fibrosis
According to national serological surveys, approximately 75 million people in China are chronically infected with hepatitis B virus. A significant subset develops CHB with progressive fibrosis. Based on internal modeling of epidemiologic and staging data, Gyre estimates that approximately 2.6 million patients in China have been diagnosed with compensated F2-F4 CHB fibrosis, representing the initial addressable market for Hydronidone. CHB remains the leading cause of liver fibrosis in China, and currently no approved anti-fibrotic therapies exist for this population.
Hydronidone is uniquely positioned to address this significant and urgent unmet medical need. Gyre was granted Breakthrough Therapy Designation in 2021 by the NMPA.
About Hydronidone (F351)
Hydronidone (F351) is a structural analogue of Pirfenidone, for which Gyre received first-in-class approval in China in 2011 for the treatment of idiopathic pulmonary fibrosis (IPF). Hydronidone exhibits enhanced potency in inhibiting p38γ kinase activity and TGF-β1-induced collagen synthesis in hepatic stellate cells (HSCs), key drivers of liver fibrosis. It also demonstrates anti-proliferative activity in HSCs through upregulation of Smad7, which downregulates TGF-βRI, thereby suppressing both the p38γ and Smad2/3 fibrogenic pathways.
Hydronidone has shown robust anti-fibrotic activity in multiple preclinical models, including the CCl₄-induced mouse model, DMN- and HSA-induced rat models, and a MASH model combining CCl₄ with a Western high-fat diet. In a randomized, double-blind, placebo-controlled Phase 3 trial, Hydronidone 270 mg/day significantly reduced liver fibrosis in CHB patients after 52 weeks of treatment. Compared to Pirfenidone, Hydronidone’s unique Phase II conjugation metabolism may contribute to an improved hepatic safety profile.
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis including MASH in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the PRC, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts and timing of expected clinical trials, including timing of a U.S. Phase 2 clinical trial initiation in the second half of 2025 and NDA submission to NMPA for F351. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings the Company may make with the Securities and Exchange Commission.
Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
Key Points: – Sanofi to acquire Vigil Neuroscience for $470 million, expanding its neurology focus. – Deal includes $8 per share and a $2 contingent value right tied to an Alzheimer’s candidate. – The acquisition strengthens Sanofi’s long-term R&D pipeline without impacting 2025 guidance.
In a strategic move to deepen its commitment to neuroscience and neurodegenerative disorders, French pharmaceutical giant Sanofi (SASY.PA) announced it will acquire Vigil Neuroscience (VIGL.O), a U.S.-based clinical-stage biotech company, in a deal valued at $470 million. The transaction includes an upfront cash payment of $8 per share, along with a $2 per share contingent value right (CVR) tied to the progress of Vigil’s Alzheimer’s drug candidate, VG-3927.
The acquisition signals Sanofi’s growing ambition in the neurology space, particularly in the high-stakes race to develop effective treatments for Alzheimer’s disease, a market expected to grow dramatically as global populations age. VG-3927, an oral drug currently in clinical development, is the centerpiece of the deal and could offer a differentiated approach to treating Alzheimer’s by targeting the TREM2 receptor, which plays a role in immune responses in the brain.
This deal is part of a broader, aggressive push by Sanofi into neuroscience and U.S.-based innovation. Earlier this month, the company announced it would invest $20 billion in the U.S. through 2030, a capital injection aimed at bolstering research, development, and domestic manufacturing capabilities. The acquisition of Vigil aligns with this strategic direction, expanding Sanofi’s U.S. biotech footprint and pipeline in tandem.
The CVR component of the deal is particularly notable. CVRs are often used in biotech mergers to tie additional shareholder value to the success of specific development milestones. In this case, the extra $2 per share is dependent on the advancement of VG-3927, which could become a valuable addition to Sanofi’s neurology portfolio if it clears clinical and regulatory hurdles.
Sanofi already had a vested interest in Vigil before this announcement. In June 2024, the French firm made a $40 million equity investment in Vigil, securing exclusive negotiation rights to VG-3927. This prior relationship helped pave the way for the full acquisition, giving Sanofi a head start in due diligence and integration planning.
Interestingly, Vigil’s other key asset, VGL101, a monoclonal antibody program, is excluded from the acquisition and will be returned to its original licensor, Amgen (AMGN). This indicates Sanofi’s laser focus on VG-3927 and its potential as an oral therapy—a more scalable and patient-friendly alternative to injectable biologics currently used in Alzheimer’s treatment.
The transaction is expected to close in the third quarter of 2025, pending customary regulatory approvals. Sanofi confirmed that the acquisition would not impact its 2025 financial guidance, suggesting it is being funded through existing capital reserves or allocated R&D spending.
As big pharma continues to chase the next blockbuster treatment in neurology, Sanofi’s acquisition of Vigil could position the company as a stronger contender in the evolving Alzheimer’s market—provided VG-3927 delivers on its clinical promise.
Investigator-initiated Phase 2 trial to evaluate TNX-102 SL’s potential to reduce severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD)
Trial is sponsored by the University of North Carolina (UNC) and supported by a grant from the U.S. Department of Defense
Topline results from the trial are expected in the second half of 2026
CHATHAM, N.J., May 21, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced the first patient has been dosed in the Phase 2, investigator-initiated OASIS trial to evaluate TNX-102 SL in reducing the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD). The trial is sponsored by the University of North Carolina (UNC) Institute for Trauma Recovery and supported by a $3 million grant from the U.S. Department of Defense (DoD).
“TNX-102 SL has been shown to improve sleep quality in PTSD, and previous trials of TNX-102 SL suggested activity on sleep and stress-related symptoms in the first several weeks of treatment,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Addressing sleep disturbances is crucial in managing ASR, as poor sleep can exacerbate other symptoms and hinder recovery. There is a significant unmet need for treating ASR after traumatic events, such as civilian motor vehicle collisions or warfighter experiences in forward bases or in theater. We are encouraged by the support of TNX-102 SL’s prior data improving PTSD symptomatology in the first several weeks of treatment, which may be crucial to reducing ASR symptoms and their sequalae. We look forward to topline results in the second half of 2026.”
The Optimizing Acute Stress Reaction Interventions with TNX-102 SL (OASIS) trial will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients presenting to the emergency department (ED) after a motor vehicle collision (MVC). The trial plans to enroll approximately 180 MVC-trauma survivors at ED study sites around the U.S. Participants will be randomized in the ED to receive a two-week course of either TNX-102 SL 5.6 mg or placebo.
The OASIS trial will build upon a foundation of knowledge and infrastructure developed through the UNC-led, $40 million AURORA initiative. AURORA is a major national research initiative to improve the understanding, prevention and recovery of individuals who experience a traumatic event. AURORA is supported by funding from the National Institutes of Health (NIH), leading brain health nonprofit One Mind, private foundations, and partnerships with leading tech companies, such as Mindstrong Health and Verily Life Sciences, the healthcare arm of Alphabet, the parent company of Google.
Acute and chronic stress disorders can affect both civilian and military populations. According to the National Center for PTSD, in the U.S. about 60% of men and 50% of women experience at least one trauma in their lives In the U.S. alone, one-third of ED visits (40-50 million patients per year) involve evaluation after trauma exposures, and in a 2014 study involving 3,157 US veterans, 87% reported exposure to at least one potentially traumatic event during their service. Moreover, as many as 500,000 U.S. troops who served in wars between 2001 and 2015 were diagnosed with PTSD. Currently, no medication is available in the immediate aftermath of traumatic events to treat the initial reaction and support long term health via a post-trauma clinical trajectory that prevents development or worsening of ASD, thereby also preventing PTSD.
For more information, see ClinicalTrials.gov Identifier: NCT06636786
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-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors. Together, these interactions are believed to target the non-restorative sleep characteristic of fibromyalgia 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 biotech company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s 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’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent 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, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, 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.
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 (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
LOS ALTOS, Calif., May 21, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (NASDAQ: UNCY) (“Unicycive” or the “Company”), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced a change in the time of the 2025 Annual Meeting of Stockholders (the “Annual Meeting”). The previously announced date of the meeting (June 9, 2025) and location of the meeting (4300 El Camino Real, Suite 210, Los Altos, CA 94022) will not change, but the meeting will be held at 7:00 a.m., Pacific Daylight Time, on that date. Stockholders of record as of the close of business on April 30, 2025, the record date, can find additional details regarding participation in the Annual Meeting at https://annualgeneralmeetings.com/uncy2025.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information about Unicycive, visit Unicycive.com and follow us on LinkedIn and X.
GEO-CM04S1 Demonstrates Superior Protection in Immunocompromised Populations; Fully Aligned with HHS Priorities for Durable, Broad-Spectrum Immunization
ATLANTA, GA, May 20, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today issued a statement in response to the U.S. Department of Health and Human Services’ (HHS) anticipated changes to COVID-19 vaccine recommendations.
According to recent reports, HHS is preparing to limit blanket vaccine guidance in favor of a risk-based approach focused on older adults and those with chronic health problems. This pivot away from one-size-fits-all vaccine recommendations underscores the urgent need for next-generation immunization strategies—precisely the role that GeoVax’s multi-antigen COVID-19 vaccine, GEO-CM04S1, is designed to fulfill.
“As public health strategy shifts toward protecting those most vulnerable, the demand increases for vaccines that work where others fall short,” said David Dodd, Chairman and CEO of GeoVax. “GEO-CM04S1 delivers broad, durable immunity even in immunocompromised patients—a population estimated at over 40 million adults in the U.S. that are inadequately served by the current authorized, single-antigen mRNA vaccines.”
GEO-CM04S1: Purpose-Built for the New Vaccine Paradigm
GEO-CM04S1 is based on the Modified Vaccinia Ankara (MVA) platform and expresses both Spike (S) and Nucleocapsid (N) proteins—offering multi-antigen protection against SARS-CoV-2. This broader design induces both antibody and T cell responses, essential for robust, durable protection against continually evolving COVID-19 variants and is especially critical in populations with weakened immune systems.
Recent interim results from a Phase 2 clinical trial in patients with chronic lymphocytic leukemia (CLL) demonstrated a superior T cell response rate versus a leading mRNA vaccine. The trial’s independent Data Safety Monitoring Board recommended and implemented continuing enrollment in the GEO-CM04S1 arm while halting the underperforming mRNA comparator arm.
Aligned with the New HHS Biosecurity Vision
GEO-CM04S1 is fully aligned with the new strategic direction from HHS Secretary Kennedy, who has called for a focus toward multi-antigen vaccine technologies that can deliver durable, variant-adaptive immunity while prioritizing safety and domestic production.
GeoVax’s MVA vaccines offer:
Multi-antigen breadth: Including both S and N antigens for protection across variants.
Durability: Sustained antibody and T cell immunity—even in immunocompromised individuals.
Safety: MVA is non-replicating and approved for use in vulnerable groups such as transplant patients, pregnant women, and children.
Domestic advanced manufacturing: Using an avian continuous cell line platform that eliminates reliance on specialized pathogen-free eggs and a slow vaccine manufacturing process, enabling scalable U.S.-based vaccine production aligned with President Trump’s recent Executive Order on pharmaceutical onshoring.
“The HHS call for broader, more resilient vaccine solutions is well-founded,” Dodd added. “GEO-CM04S1 is not only scientifically advanced but strategically aligned with our nation’s public health and biosecurity goals.”
Multiple Trials Support Path to Licensure
GEO-CM04S1 is currently in three active Phase 2 trials, evaluating its use among:
Immunocompromised blood cancer patients in preparation for stem cell transplantation or CAR-T therapy (in comparison to mRNA-based vaccine),
Immunocompromised patients with Chronic Lymphocytic Leukemia (in comparison to mRNA vaccine), and
Healthy adults, previously vaccinated with a mRNA vaccine as a more robust, more durable booster following mRNA vaccination.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Key Points: – Regeneron to acquire 23andMe’s assets, including its vast genetic data bank, for $256 million. – The deal raises significant privacy concerns among customers and regulators. – Despite bankruptcy, 23andMe’s consumer services will continue under Regeneron’s oversight.
In a major move with wide-reaching implications for healthcare, privacy, and small-cap investors, Regeneron Pharmaceuticals has announced its acquisition of embattled DNA-testing company 23andMe for $256 million. The deal comes as 23andMe, once valued at over $6 billion following its 2021 public debut, filed for Chapter 11 bankruptcy earlier this year after prolonged profitability issues.
The acquisition includes 23andMe’s flagship Personal Genome Service, its Total Health and Research Services businesses, and a massive biobank of consumer genetic data collected over the years. While this trove of genetic information presents an invaluable asset for advancing personalized medicine, it also ignites fresh concerns about consumer privacy, data protection, and ethical oversight.
Regeneron, a major player in biotechnology and pharmaceuticals, has committed to maintaining 23andMe’s existing privacy protections and compliance with applicable laws. A court-appointed ombudsman will oversee the company’s plans for handling consumer data, and Regeneron has pledged transparency and high standards in its management of the sensitive dataset.
“We assure 23andMe customers that we are committed to protecting the 23andMe dataset with our high standards of data privacy, security and ethical oversight and will advance its full potential to improve human health,” said Aris Baras, a senior vice president at Regeneron.
The transaction, expected to close in Q3 2025, ensures that 23andMe’s genome services will continue without interruption. However, many former customers remain uneasy. When the company filed for bankruptcy, California Attorney General Rob Bonta advised users to request deletion of their genetic data and destruction of any physical samples stored by the company.
Despite reassurances from both Regeneron and 23andMe that existing privacy policies—designed to prevent data sharing with employers, insurers, law enforcement, and public databases—will remain in effect, skepticism lingers. This is particularly relevant in an age where genetic data is increasingly valuable for drug development, disease prediction, and targeted therapies.
For small-cap investors, this deal is noteworthy for several reasons. First, it reflects a growing trend of larger pharmaceutical firms acquiring innovative—but financially struggling—startups to bolster their pipelines and data assets. Second, it highlights the inherent volatility and risks associated with investing in biotech startups, especially those that go public with limited monetization strategies.
23andMe’s rise and fall underscore the importance of business sustainability in data-centric healthcare models. Meanwhile, Regeneron’s acquisition offers a potential long-term payoff through access to a highly unique, large-scale genomic dataset that could fuel years of research and development.
Investors will be watching closely how Regeneron integrates 23andMe’s assets and navigates the complex ethical landscape surrounding personal genetic data.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
1Q25 Had Lower Expenses Than We Projected. Eledon reported a loss of $6.5 million or $(0.08) per share, including a gain of $10.1 million related to fair value of warrant liabilities. Without this one-time item, the loss would have been $16.6 million or $(0.21) per share, as Research and Development expense increased less from the previous quarters than we anticipated. We expect R&D to be relatively steady as the Phase 1b and Phase 2 BESTOW trials conclude later in FY2025. Cash on March 31, 2025, was $124.9 million.
Phase 1b Trial Data Expected Mid-Year. The Phase 1b open-label trial is testing an anti-rejection regimen using tegoprubart in kidney transplantation. We see this as important data, since the Phase 2 BESTOW trial is testing this regimen against the standard regimen with tacrolimus. Since historical data for the tacrolimus regimen has been published, we believe the Phase 1b data has some predictive value for the Phase 2 BESTROW trial.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Fourth Quarter Included New Data On Norovirus Variants. Cocrystal reported a 1Q25 loss of $2.3 million or $(0.23) per share. During the quarter the company announced Phase 1 results from its CDI-988 study in norovirus. Importantly, preclinical data showed efficacy against new norovirus variants. We believe this provides additional support to Cocrystal’s method of targeting highly-conserved viral replication enzymes to make effective drugs against both current and future variants. Cash on March 31, 2025 was $6.9 million.
CDI-988 Activity Includes New Variant Strains. CDI-988 is a protease inhibitor in development for norovirus and corona virus. CDI-988 has shown activity against multiple strains, with new preclinical data in April 2025 showing efficacy against the GII.17 and GII.4 strains that have recently been most prevalent. Results from the Phase 1 high-dose cohort in healthy subjects is expected to be announced in 2Q2025. A human challenge trial is planned for later in FY2025 to evaluate CDI-988 for treatment and prophylaxis against norovirus.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
1Q25 Showed Expected Year-Over-Year Growth. Zomedica reported 1Q25 loss of $63.9 million or $(0.07) per share, including an Impairment Expense of $55.8 million related to the company’s lower market capitalization and stock price. Excluding this charge, Net Loss would have been about $8.0 million. Revenues of $6.5 million showed an annual increase of 3.8% over 1Q24. As expected, there was a seasonal decline from 4Q24 due to the year-end effect on equipment spending. Cash and equivalents on March 31, 2025 were $64.6 million.
Product Mix Reflects Growing User Base. During the quarter, Consumables increased to 70% of sales with Capital Equipment at 30% of sales. This shifting product mix reflects an increasing total number of instruments in use and more assay offerings to increase utilization of each instrument. We expect the consumable segment to continue its growth as additional capital equipment sales add to the user base and introduction of new assays increases the number of tests run on each instrument.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
PONTE VEDRA, Fla. – Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today announced manufacturing and supply chain milestones for its lead drug candidate, tecarfarin, a novel oral vitamin K antagonist (VKA) anticoagulant that is designed to address unmet needs in anticoagulation therapy.
Cadrenal completed the technical transfer and manufacturing of its tecarfarin drug substance in accordance with current good manufacturing practices (cGMP) earlier this year at a U.S. site of a leading global Contract Development and Manufacturing Organization (CDMO). Manufacturing of the tecarfarin drug product candidate is currently underway.
“We are pleased with the important progress we have made with the supply chain and cGMP manufacturing process for tecafarin,” said Quang X. Pham, Chairman & CEO. “This is a key milestone as we support our clinical development strategy and tecarfarin’s potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation.”
About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing therapeutics for patients with cardiovascular disease. Cadrenal’s lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that addresses unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for several indications, extensive clinical and real-world data have shown it can have significant, serious side effects.
Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted mechanical circulatory support devices, including Left Ventricular Assisted Devices (LVADs). The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib).
Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit https://www.cadrenal.com/ and connect with us on LinkedIn.
Safe Harbor
Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding tecarfarin’s potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation and pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. 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 provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation, the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, 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.
In vitro testing with CDI-988 demonstrated superior broad-spectrum antiviral activity against major norovirus variants
BOTHELL, Wash., May 15, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three months ended March 31, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities.
“Our oral pan-viral protease inhibitor CDI-988 is a potential breakthrough first-in-class treatment and prophylaxis for norovirus, a debilitating gastrointestinal infection that strikes millions globally each year,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “By precisely targeting the virus’ core replication machinery, we believe CDI-988 effectively combats all major strains of this highly contagious pathogen with exceptional in vitro activity demonstrated against the current circulating GII.17 and GII.4 strains. We’re preparing to launch a U.S. human challenge study in the coming months – a critical step in advancing this transformative therapy to patients worldwide.
“Our novel, broad-spectrum drug candidates have the potential to fundamentally transform how we fight viral threats worldwide,” said James Martin, CFO and co-CEO of Cocrystal. “We’re advancing development of these assets for multibillion-dollar markets while remaining committed to a capital-efficient business model to maximize shareholder value.”
Antiviral Product Pipeline Overview
We harness our revolutionary structure-based drug discovery platform technology to engineer next-generation, broad-spectrum antivirals that precisely disrupt viral replication mechanisms. Unlike traditional approaches, our platform technology identifies compounds that bind to highly conserved regions of viral enzymes, thereby creating a formidable defense against current viral threats as well as their mutations. By specifically targeting these evolutionary-constrained viral regions, our candidates maintain efficacy even as viruses mutate, while simultaneously minimizing off-target interactions that typically lead to adverse side effects. This dual advantage represents a significant breakthrough in antiviral drug development. Our innovative methodology fundamentally transforms the conventional drug discovery paradigm by eliminating the inefficient, resource-intensive cycles of high-throughput compound screening and prolonged hit-to-lead optimization. The result is faster identification of promising candidates with superior resistance profiles and safety characteristics.
Oral CC-42344 for the treatment of pandemic and seasonal influenza A
Our novel PB2 inhibitor CC-42344 showed excellent in vitro activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®.
In December 2022 we reported favorable safety and tolerability results from the oral CC-42344 Phase 1 study.
In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of CC-42344 in influenza A-infected subjects in the United Kingdom, following authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
In May 2024 we completed enrollment in the Phase 2a human challenge study.
In June 2024 we reported that in vitro studies demonstrated CC-42344 inhibits the activity of the highly pathogenic avian influenza A (H5N1) PB2 protein identified in humans exposed to infected dairy cows.
In December 2024 we announced a plan to extend the CC-42344 Phase 2a human challenge study due to unexpectedly low influenza infection among study participants.
Inhaled CC-42344 as prophylaxis and treatment for pandemic and seasonal influenza A
Our preclinical testing showed superior pulmonary pharmacology with CC-42344, including high exposure to drug and a long half-life.
Dry powder inhalation formulation development and toxicology studies have been completed.
Influenza A/B program
Our efforts to develop a preclinical lead of novel influenza replication inhibitors are ongoing.
Norovirus Program Norovirus is a common and highly contagious virus that causes symptoms of acute gastroenteritis among people of all ages including nausea, vomiting, stomach pain and diarrhea as well as fatigue, fever and dehydration. Norovirus infection can be significantly more severe and prolonged in specific risk groups including infants, children, the elderly and people with immunodeficiency. Norovirus outbreaks occur most commonly in semi-closed communities and have become notorious for their occurrence in hospitals, nursing homes, childcare facilities, cruise ships, schools, disaster relief sites and military settings.
Oral pan-viral protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses
Our novel, broad-spectrum protease inhibitor CDI-988 is being evaluated as a potential oral treatment for noroviruses and coronaviruses.
CDI-988 has shown in vitro pan-viral activity against multiple norovirus strains.
In May 2023 we announced approval of our application to the Australian regulatory agency for a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability and pharmacokinetics (PK) of oral CDI-988 in healthy subjects.
In August 2023 we announced our selection of CDI-988 as our lead compound for the oral treatment for noroviruses, in addition to coronaviruses.
In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study.
In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort.
In April 2025 we announced that CDI-988 showed superior broad-spectrum antiviral activity against GII.17 strains, the most prevalent strain in the U.S. and European countries in 2024-2025.
We expect to report topline oral CDI-988 Phase 1 results from the high-dose healthy subject cohort in the second quarter of 2025.
We plan to initiate a human challenge study in the U.S. in the coming months to evaluate CDI-988 as a norovirus treatment and prophylaxis.
SARS-CoV-2 and Other Coronavirus Program By targeting viral replication enzymes and proteases, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including SARS-CoV-2 and its variants, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. The global COVID-19 therapeutics market is estimated to exceed $16 billion annually by the end of 2031.
Oral pan-viral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses
CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and PK properties.
In September 2023 we dosed the first healthy subject in our dual pan-norovirus/pan-coronavirus oral CDI-988 study, which is expected to serve as a Phase 1 study for both indications.
In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study.
In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort.
We expect to report topline oral CDI-988 Phase 1 results from the high-dose healthy subject cohort in the second quarter of 2025.
First Quarter Financial Results
Research and development (R&D) expenses for the first quarter of 2025 were $1.4 million, compared with $3.0 million for the first quarter of 2024, with the decrease primarily due to a reduction in personnel costs and the timing of clinical study costs. General and administrative (G&A) expenses for the first three months of 2025 were $1.0 million, compared with $1.2 million for the first three months of 2024, with the decrease primarily due to a reduction in insurance costs and other expenses.
Net loss for the first quarter of 2025 was $2.3 million, or $0.23 per share, compared with net loss for the first quarter of 2024 of $4.0 million, or $0.39 per share.
Cocrystal reported unrestricted cash as of March 31, 2025 of $6.9 million, compared with $9.9 million as of December 31, 2024. Net cash used in operating activities for the first quarter of 2025 was $2.9 million, compared with $4.5 million for the first quarter of 2024. The Company had working capital of $6.9 million and 10.2 million common shares outstanding as of March 31, 2025.
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. 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 our plans for the future development of preclinical and clinical product candidates including the potential of our norovirus product candidate, our plans to initiate a human challenge study for our norovirus product candidate, and our plans with regard to initiating a second human challenge study for CC-42344 The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from our need for additional capital to fund our operations over the next 12 months, inflation, the possibility of a recession, interest rate increases, imposed and threated tariffs, and geopolitical conflicts including those in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the progress and results of the studies for CC-42344 and CDI-988 including the delay of the Phase 2a study for CC-42344 which may require us to incur substantial additional costs, the ability of us and our CROs to recruit volunteers for, and to otherwise proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes including potential downward pressure on government spending on the biopharmaceutical and healthcare industry based on policies and actions taken by the Trump Administration in the U.S., the impact of the Trump Administration’s policies and actions on regulation affecting the FDA and other healthcare agencies and potential staffing issues resulting therefrom, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the potential for the development of effective treatments by competitors which could reduce or eliminate a prospective future market share commercializing any product candidates we may develop in the future, and our ability to meet our future liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. 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.
