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.
Quarter Sales Were Driven By Etuary. Gyre reported Net Income of $5.9 million or $0.04 per basic share. Revenue of $30.6 million showed year-over-year growth of 20.0%. This was driven by strength in Etuary with sales of $27.7 million. Sales of Etorel and Contiva sales were of $1.5 million and $1.2 million respectively. At the end of 3Q25 on September 30, the company had $80.3 in cash, equivalents, and securities.
The Company Made Progress In Several Important Clinical Programs. During 3Q, Gyre continued working to submit its NDA for Hydronidone approval in China. The Phase 3 trial testing Etuary in pneumonoconiosis completed enrollment, while a Phase 2/3 trial for pulmonary complications in oncology (radiation induced lung injury/pneumonitis) is planned to begin in 4Q25. The IND for a Phase 2 trial in MASH in the US is now expected to be filed in early 2026, within the timeframe we had expected.
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.
Data from patients who remained on tegoprubart for a year post transplant showed an overall mean 12-month estimated glomerular filtration rate (eGFR) of approximately 69 mL/min/1.73 m²
Tegoprubart demonstrated a favorable safety and tolerability profile, substantially reducing the metabolic, neurologic, and cardiovascular toxicities commonly associated with tacrolimus
Supports advancement into Phase 3 development as a potential new standard for the prevention of kidney transplant rejection
Conference call to be held Friday, November 7 at 8:00 a.m. ET
IRVINE, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced results from its Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo kidney transplant. Results from the Phase 2 BESTOW clinical trial were presented today as a late breaking oral presentation titled “Efficacy and Safety of Tegoprubart for the Prevention of Rejection in Kidney Transplantation: Results from the Phase 2 BESTOW Trial,” at the American Society of Nephrology’s Kidney Week 2025 Annual Meeting in Houston, TX.
“The Phase 2 BESTOW data results demonstrate tegoprubart’s potential to maintain excellent kidney function while reducing the chronic metabolic, neurologic, and cardiovascular toxicities that burden patients on tacrolimus,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “By pairing strong immunosuppressive efficacy with a differentiated safety profile, including dramatically lower rates of new-onset diabetes, tremor, and dialysis-requiring delayed graft function, tegoprubart represents a promising next-generation option for kidney transplant immunosuppression as we advance into Phase 3.”
“There remains a significant unmet need for safer alternatives to traditional tacrolimus-based immunosuppression regimens—options that can reduce harmful side effects without compromising efficacy. The Phase 2 results presented at ASN Kidney Week highlight the potential of tegoprubart to deliver strong graft function after kidney transplantation, while avoiding the long-term toxicities often associated with current standard of care,” said Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief, Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota. “It’s been more than a decade since we’ve seen true innovation in transplant immunosuppression. These data offer real hope that patients may soon have a transformative therapy that improves their health outcomes and overall quality of life.”
Study Design
The 12-month, randomized, head-to-head, Phase 2 study enrolled 127 kidney transplant recipients (63 receiving tegoprubart and 64 receiving tacrolimus) across 44 global sites. The study directly compared tegoprubart-based immunosuppression with a tacrolimus-based regimen. All patients also received rabbit antithymocyte globulin (rATG) induction and maintenance therapy with mycophenolate mofetil (MMF/MPA) and corticosteroids.
The study’s primary efficacy endpoint was the change in eGFR at 12 months post-transplant. Secondary endpoints included biopsy-proven acute rejection (BPAR), patient and graft survival, composite efficacy failure, iBox score, donor-specific antibodies (DSAs), delayed graft function (DGF), and new-onset diabetes after transplantation (NODAT).
Safety Results
Safety findings underscore tegoprubart’s potential to maintain effective immunosuppression while minimizing the metabolic, neurologic, and cardiovascular toxicities characteristic of tacrolimus-based therapy.
Metabolic effects: New-onset diabetes developed in approximately 1 in 6 patients receiving tacrolimus versus 1 in 47 receiving tegoprubart.
Neurologic effects: Tremor was markedly higher in the tacrolimus group (25.0% vs. 1.6%).
Cardiovascular effects: Hypertension (15.9% vs. 25.0%), hypertensive crisis (1.6% vs. 7.8%), and heart failure (0% vs. 4.7%) all favored tegoprubart.
Renal recovery: Delayed graft function occurred less often with tegoprubart and required shorter dialysis (14.3% vs. 25.0%; 4.6 days vs. 6.1 days), suggesting potential reductions of 115 days on dialysis post-transplant per 100 deceased donor kidney recipients on tegoprubart vs. tacrolimus.
Infections: Sepsis or bacteremia occurred more frequently in the tacrolimus arm (17.2% vs. 4.8%). Viral infection rates (CMV, BK, EBV, fungal) were similar across groups, with no cases of Post-Transplant Lymphoproliferative Disorder (PTLD) or Progressive Multifocal Leukoencephalopathy (PML).
Overall rates of serious adverse events were comparable between treatment arms.
Efficacy Results
eGFR on tegoprubart treatment was 69 mL/min/1.73 m² (n=51) at 12 months vs. 66 mL/min/1.73 m² for tacrolimus (n=56). Although the primary endpoint did not reach statistical significance, tegoprubart maintained strong renal function, delivering what the Company believes is the highest mean eGFR level reported to date in kidney transplant clinical trials evaluating rejection prevention.
Subgroup analyses demonstrated higher eGFRs in nearly all tegoprubart subgroups compared with tacrolimus, particularly among living-related donor recipients (~72 mL/min/1.73 m² vs. 62 mL/min/1.73 m²) and high Kidney Donor Profile Index (KDPI > 35) transplants (~62 mL/min/1.73 m² vs. 53 mL/min/1.73 m²).
In the deceased donor subgroup, tegoprubart achieved a mean eGFR of approximately 68 mL/min/1.73 m² at 12 months.
The efficacy failure composite endpoint, comprising death, graft loss and biopsy proven acute rejection, is the approval endpoint currently recognized by the U.S. Food and Drug Administration. Efficacy failure composite endpoint was 22% in the tegoprubart group vs. 17% in the tacrolimus group, demonstrating non-inferiority for tegoprubart vs. tacrolimus, using a 20% non-inferiority margin. The Company believes these results, if replicated in a Phase 3 study, would be sufficient to support tegoprubart’s approvability.
The rate of acute rejection in all biopsies was 20.6% in the tegoprubart group compared with 14.1% in the tacrolimus group.
Among patients in the tegoprubart group who experienced acute rejection and remained on treatment through month 12, mean eGFR was 73 mL/min/1.73 m², compared with 50 mL/min/1.73 m² in those who switched to tacrolimus.
There was 1 case of donor-specific antibodies (DSA) in the tegoprubart arm vs. 2 in the tacrolimus arm.
Next Steps
Based on these results, Eledon plans to advance tegoprubart into Phase 3 development following discussions with regulators on study design and data requirements. Insights from the Phase 2 BESTOW data set and the ongoing long-term extension study will be incorporated to optimize the Phase 3 protocol and strengthen the regulatory package.
Estimated cash, cash equivalents and short-term investments totaled approximately $93.4 million as of September 30, 2025. The company expects current cash, cash equivalents and short-term investments to fund operations to late 2026.
Conference Call
Eledon will hold a conference call on November 7, 2025, at 8:00 a.m. Eastern Time to discuss the Phase 2 BESTOW trial results presented at Kidney Week. The dial-in numbers are 1-800-717-1738 for domestic callers and 1-646-307-1865 for international callers. The conference ID is 92427. A live webcast of the conference call will be available on the Investor Relations section of the Company’s website at www.eledon.com. The webcast will be archived on the website following the completion of the call and a copy of the presentation for the conference call will be posted on the Company’s website at https://ir.eledon.com/investor-relations prior to the conference call.
Full details of the oral presentation are below:
Title: Efficacy and Safety of Tegoprubart for the Prevention of Rejection in Kidney Transplantation: Results from the Phase 2 BESTOW Trial Session Title: Late-Breaking Research Orals – 1 Presenter: Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota Session Date and Time: November 6, 2025, from 4:30 p.m. to 6:00 p.m. CT
Eledon is also conducting an ongoing open label Phase 1b study (NCT05027906) and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. Participants who complete 12 months of treatment in the Phase 1b and Phase 2 BESTOW trials are eligible to enroll into the long-term extension study.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
Statement Regarding Preliminary Financial Information
The cash, cash equivalents and short-term investments presented in this press release is unaudited and preliminary and is subject to completion of financial closing procedures, including the completion of management’s review. The preliminary financial information is based on information currently available to management, and may vary from the amounts that will be reported in Eledon’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 that the Company will file with the U.S. Securities and Exchange Commission.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about ongoing, planned and future clinical trials, the development of product candidates, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with kidney transplantation, submissions to regulators, our expected cash, cash equivalents and short-term investments as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and uncertainties relating to the completion of our quarter-end closing procedures for our financial statements for the quarter ended September 30, 2025. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Phase 2/3 OCU410ST GARDian3 pivotal confirmatory trial is progressing toward 1H 2027 Biologics License Application (BLA) filing with 50% enrollment completed to date
European Medicines Agency (EMA) provided acceptability of a single U.S.-based trial for submission of a Marketing Authorization Application (MAA)
Executed licensing agreement with Kwangdong Pharmaceutical for exclusive rights in South Korea to OCU400
Sales milestones of $1.5 million for every $15 million of sales in South Korea, projected to reach $180 million or more in first 10 years of commercialization and royalties equaling 25% of net sales
Closed $20 million registered direct offering of common stock and accompanying premium warrants
The Company will receive $30 million of additional gross proceeds if the warrants are exercised in full
MALVERN, Pa., Nov. 05, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today reported third quarter 2025 financial results along with a general business update.
“With two late-stage modifier gene therapies on track to meet 2026 and 2027 BLA/MAA filings, it’s remarkable to look back and recognize we only began dosing the first patient in the Phase 1/2 OCU400 clinical trial in 2022,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “The OCU410ST Phase 2/3 GARDian3 pivotal confirmatory trial is following close behind the OCU400 Phase 3 liMeLiGhT clinical trial, and with 50% enrollment completed to date, we believe recruitment will be completed in the first quarter of 2026. This progress not only reinforces our commitment to file three BLAs in the next three years, but it also brings us closer to addressing the incredible unmet medical needs that exist for patients facing vision loss.”
In September, Ocugen announced its exclusive licensing agreement with Kwangdong Pharmaceutical Co., Ltd. (Kwangdong) for the rights to OCU400 in South Korea. Under the agreement, the Company will receive up to $7.5 million in upfront and development milestone payments, plus sales milestones of $1.5 million for every $15 million of sales in South Korea, projected to reach $180 million or more in the first 10 years of commercialization. The Company will also earn a 25% royalty on net sales generated by Kwangdong and will be responsible for manufacturing and supplying OCU400. A regional approach preserves Ocugen’s rights to larger geographies to maximize total patient reach while also generating a potential return for shareholders.
Enrollment in the OCU400 Phase 3 liMeliGhT clinical trial is nearing completion, and the program remains on track for BLA and MAA submissions in 2026. This is the only known broad retinitis pigmentosa (RP) gene-agnostic trial to address multiple genetic mutations and multiple disease pathways with a single therapeutic approach. There are approximately 300,000 people in the U.S. and Europe combined living with RP, which affects greater than 100 genes. Ocugen’s gene-agnostic approach has the potential to treat multiple gene mutations associated with RP with a one-time subretinal injection.
The Phase 2/3 GARDian3 pivotal confirmatory trial for OCU410ST for Stargardt disease is well underway and in August the Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA provided acceptability of a single U.S.-based trial for submission of an MAA. Stargardt disease affects approximately 100,000 people in the U.S. and Europe combined, and approximately 1 million globally. Currently, there is no FDA-approved treatment available for Stargardt disease.
Also in August, Ocugen closed a registered direct offering pursuant to a securities purchase agreement with Janus Henderson Investors for the purchase and sale of 20,000,000 shares of common stock and warrants to purchase up to an aggregate of 20,000,000 shares of common stock at a purchase price of $1.00 per share and accompanying warrant at a premium exercise price of $1.50 per share. The gross proceeds to the Company were approximately $20 million, which Ocugen anticipates will extend the Company’s cash runway into the second quarter of 2026. The Company will receive $30 million of additional gross proceeds if the warrants are exercised in full extending runway into 2027.
“We will continue to pursue financing opportunities along with strategic business development to fund the Company into commercialization,” said Dr. Musunuri. “We have engaged with potential funding and business partners during various investor and global conferences. I look forward to additional substantive conversations between now and the end of the year.”
Upcoming inflection points for Ocugen’s novel modifier gene therapy platform include OCU410 (Geographic Atrophy) Phase 2 full data release expected in the first quarter of 2026, OCU410ST (Stargardt disease) interim data on 50% of patients at eight months of treatment expected mid-year 2026, and OCU400 (RP) Phase 3 top line data expected in the fourth quarter of 2026. The Company looks forward to providing the market and key stakeholders with near-term catalysts supporting Ocugen’s strong path forward.
OCU400 – Enrollment in the Phase 3 liMeliGhT clinical trial is nearing completion. The Company secured an exclusive licensing agreement with Kwangdong for rights to OCU400 in South Korea and will continue to pursue regional partnerships. Intend to initiate BLA rolling submission in the first half of 2026 and release Phase 3 top-line data in the fourth quarter of 2026.
OCU410ST – Pivotal confirmatory Phase 2/3 trial is ahead of schedule. CHMP of the EMA provided acceptability of a single U.S.-based trial for submission of an MAA. Intend to release interim data (50% of patients at 8 months of treatment) mid-year 2026.
OCU410 – Intend to release full data from the Phase 2 clinical trial in the first quarter of 2026 and begin Phase 3 in 2026.
Ophthalmic Biologic Product
OCU200 – Intend to complete enrollment in the Phase 1 clinical trial in 4Q 2025.
Third Quarter 2025 Financial Results
With the recent $20 million financing in the third quarter, we expect our current cash position provides sufficient runway to operate through 2Q 2026.
The Company’s cash, cash equivalents and restricted cash totaled $32.9 million as of September 30, 2025, compared to $58.8 million as of December 31, 2024.
Total operating expenses for the three months ended September 30, 2025 were $19.4 million and included research and development expenses of $11.2 million and general and administrative expenses of $8.2 million. This compares to total operating expenses for the three months ended September 30, 2024 of $14.4 million that included research and development expenses of $8.1 million and general and administrative expenses of $6.3 million.
Conference Call and Webcast Details
Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.
Attendees are invited to participate on the call or webcast using the following details:
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers Conference ID: 3029428 Webcast: Available on the events section of the Ocugen investor site
A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.
About Ocugen, Inc. Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X and LinkedIn.
Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs, Ocugen’s financial condition and expected cash runway into the second quarter of 2026, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines,and Ocugen’s projections under its license agreement with Kwangdong Pharmaceutical Co., Ltd., which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our annual and periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Atlanta, GA – November 4, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today announced that it will report its financial results for the quarter ended September 30, 2025, after the close of U.S. markets on Thursday, November 13, 2025. Following the release, management will host a live conference call and audio webcast at 4:30 p.m. ET to review results and provide a business update.
Conference Call Details
To access the live conference call, participants may register in advance here (https://edge.media-server.com/mmc/p/u86rmdmb/). The live audio webcast of the call will be available via the “Events & Presentations” section of the Company’s Investor Relations website at www.geovax.com/investors. To participate via telephone, please register using the link above; registrants will receive a confirmation email with dial-in information, a unique passcode, and access instructions. Although registration is not required, participants are encouraged to join ten minutes prior to the scheduled start. An archive of the webcast will be available on the Company’s website approximately two hours after the conclusion of the call and will remain available for at least 90 days.
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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. 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.
Planning to initiate an open-label Phase 2 study of TNX-1500 under an investigator-initiated IND to evaluate safety and activity in the first half of 2026
Novel immunomodulatory regimen designed to reduce calcineurin inhibitor exposure and improve outcomes
Dimeric Fc-modified mAb TNX-1500 selectively targets cell-associated CD40L with once-monthly dosing
CHATHAM, N.J., Nov. 04, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated, commercial biotechnology company, today announced a collaboration with Massachusetts General Hospital (MGH), a founding member of Mass General Brigham (MGB) to conduct a Phase 2 clinical trial evaluating monoclonal antibody (mAb) TNX-1500 in kidney transplant recipients. The investigator-initiated study will be led by Ayman Al Jurdi, M.D., at MGH and is designed to assess the safety, tolerability and activity of Fc-modified anti-CD40L mAb TNX-1500 in preventing kidney transplant rejection while significantly minimizing the dose of conventional immunosuppressive drugs, which are associated with infection, cancer, cardiovascular side effects and various metabolic derangements. The CD40 ligand (CD40L) is also known as CD154. Study initiation is contingent on institutional review board (IRB) approval and FDA clearance of an investigator-initiated investigational new drug application (IND).
“TNX-1500 represents a differentiated approach that is designed to block the function of cell-associated CD40L,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Collaborating with MGH, one of the nation’s leading transplant research centers, allows us to advance this promising candidate in patients who need safer therapies with better long-term outcomes. The Fc-modified TNX-1500 has shown activity and has been well tolerated in animals1,2 and in a Phase 1 pharmacodynamic (PD) and pharmacokinetic (PK) study that supports monthly dosing. Ultimately, our goal is to establish TNX-1500 as a monotherapy, with the potential to transform the landscape of organ transplant management.”
“The ability to modulate the immune system without the toxicities associated with prolonged standard dose CNIs is one of the most pressing unmet needs in transplantation,” said Ayman Al Jurdi, M.D., Principal Investigator at MGH. “Studying TNX-1500 in this Phase II trial will allow us to explore its potential to improve long-term outcomes for kidney transplant recipients.”
Pending IRB approval and IND clearance, the open-label, single-center study will enroll five adult kidney transplant recipients at MGH. Patients will receive induction therapy with anti-thymocyte globulin, TNX-1500, tacrolimus, and corticosteroids. The corticosteroids will be tapered and discontinued by Day 33 post-transplant. TNX-1500 will be continued for 12 months (to the primary endpoint) with an option to continue treatment beyond 12 months. Tacrolimus at standard dose will be continued for six months, at which point tacrolimus will be decreased to low dose with the expectation of discontinuing tacrolimus after 12 months. The primary endpoint is the incidence of adverse and serious adverse events at 12 months. Secondary endpoints include graft survival, renal function, biopsy-proven acute rejection, and incidence of donor-specific antibodies. The study is expected to be initiated in the first half of 2026.
About TNX-1500
TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. The first-in-human Phase 1 PD/PK study of TNX-1500 was completed and topline reported in first quarter 2025 to support dosing in a planned Phase 2 trial in kidney transplant recipients. The primary objective of the Phase 1 trial was to assess the safety, tolerability, PD and PK of single-dose intravenous (i.v.) TNX-1500 at 3 mg/kg, 10 mg/kg, and 30 mg/kg. Two published articles in the peer-reviewed American Journal of Transplantation demonstrate TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent or in combination with other drugs in animal renal and heart allografts.1,2
1Lassiter G, et al. Am J Transplant. 2023;23(8):1171-1181. 2Miura S, et al. Am J Transplant. 2023;23(8):1182-1193.
Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals is a fully-integrated commercial biotechnology company with marketed products and a pipeline of development candidates. Tonix has received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is 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). TNX-102 SL is also in development for major depressive disorder. Tonix’s rare disease portfolio includes TNX-2900, intranasal potentiated oxytocin with magnesium, in development for Prader-Willi syndrome. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a monoclonal antibody for the seasonal prevention of Lyme Disease. Finally, 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, 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’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.
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 successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; 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.
INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults. CONTRAINDICATIONS TONMYA is contraindicated: In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs. During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism. WARNINGS AND PRECAUTIONS Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy. Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases. Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures. Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs. CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur. ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer. DRUG INTERACTIONS MAO inhibitors: Life-threatening interactions may occur. Other serotonergic drugs: Serotonin syndrome has been reported. CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced. Tramadol: Seizure risk may be enhanced. Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked. USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED). Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition. Pediatric use: The safety and effectiveness of TONMYA have not been established. Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions. Please see additional safety information in the full Prescribing Information. To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Relocations Strengthen Ties to Georgia’s Bio-Ecosystem and Position GeoVax for Late-Stage Development and Market Readiness
Atlanta, GA – November 3, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and multi-antigen vaccines against cancers and infectious diseases, today announced relocations of its corporate headquarters and laboratory operations to new facilities in the Atlanta metropolitan area. The moves, scheduled for fourth quarter of 2025, will support GeoVax’s continued growth, expanding pipeline, and preparation for product commercialization.
GeoVax’s laboratory group is relocating to Science Square / Portal Innovations, located in midtown Atlanta. This state-of-the-art facility will provide the Company’s R&D team with expanded access to modern laboratories and collaborative research environments designed to accelerate innovation and development activities.
The Company’s new corporate headquarters will be located at 1955 Lake Park Drive in Smyrna, Georgia, establishing a new hub for corporate operations and leadership activities.
“These moves reflect a significant milestone in GeoVax’s evolution,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “By placing members of our R&D team in one of the most dynamic bio-research ecosystems in the Southeast, and by expanding our administrative base, we are positioning GeoVax for an accelerated next stage of growth. These facilities will support our broad and advancing pipeline, which includes our promising GEO-MVA program and multiple clinical trials in cancer therapy and infectious disease vaccines.”
“We are incredibly excited for GeoVax to join Portal Atlanta at Science Square Labs,” said Eddie Lai, Director of Business Development, Atlanta Portal Innovations. “GeoVax brings a strong legacy of innovation rooted in the Southeast to the Portal Innovations ecosystem that includes 100+ innovative companies utilizing our sites across the country. As an innovation engine, Portal Innovations supports scientific companies including life sciences and biotech in all stages of development in both R&D and administrative capabilities, and GeoVax is a perfect addition to our growth right here in Atlanta.”
The relocations underscore GeoVax’s trajectory as a company focused on long-term growth, scientific advancement, and future commercialization opportunities. As the Company builds momentum with a deepening pipeline and strategic partnerships, its enhanced infrastructure will provide a strong foundation to meet global healthcare needs.
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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. 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.
Business, regulatory and clinical updates will be provided
CAMBRIDGE, Mass., Nov. 3, 2025 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that it will host an investor update meeting on December 8, 2025 at 8:30 a.m. Eastern Time.
The Company plans to provide status updates about its near-term milestones and objectives:
Phase 3 PARAGON study initiation (ALS)
Notice of Compliance with conditions (NOC/c) submission in Canada
Status of the binding term sheet executed in December 2024
RoAD Phase 2 program (Alzheimer’s disease)
Investors interested in attending the webinar are invited to register here.
About NeuroSense
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.
Forward-Looking Statements
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of regulatory filings, meetings and regulatory decisions. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Phase 3 Data To Be Presented At A Medical Meeting. Presentation of data from the Hydronidone Phase 3 trial is scheduled for Friday, November 7,2025 at the The Liver Meeting, the annual conference of the American Association for the Study of Liver Disease (AASLD). This presentation is expected to give detailed clinical data on the actions Hydronidone in liver fibrosis associated with chronic hepatitis B infection. We see this indication as proof of concept as well as a revenue opportunity.
We Expect Additional Clinical Trial Details To Be Presented. The Phase 3 trial met its primary endpoint of regression of liver fibrosis, with treated patients showing a regression rate of 52.85% compared with a placebo patient rate of 29.84% (p=0.0002). This reduction compared with placebo is both statistically significant and clinically meaningful. An important secondary endpoint, reduction in inflammation, also showed meaningful improvement.
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.
Investment by Directors and Management demonstrates confidence in the Company
Potential for an additional $1.8million upon the exercise in full of warrants
BOTHELL, Wash., Oct. 30, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (the “Company” or “Cocrystal”) announces the completion of a private placement of units priced at-the-market under Nasdaq rules with 743,024 shares of its common stock at a purchase price of $1.39 per unit for proceeds of $1.03 million and unregistered warrants to purchase up to 1,486,048 shares of common stock at an exercise price of $1.24 per share. The warrants are exercisable upon issuance and will expire in 27 months.
The four Investors in the private placement are Cocrystal Directors Phillip Frost, M.D., who co-founded the Company and serves as Chairman and CEO of OPKO Health, Inc., Fred Hassan, who is Chairman of the investment firm Caret Group and Director of the private equity firm Warburg Pincus and Richard Pfenniger, and Cocrystal co-CEO and CFO James Martin.
“It’s gratifying to join these distinguished board members, who are respected industry veterans, in a shared our commitment to advancing Cocrystal’s mission of addressing the global need for novel antiviral therapies,” said Mr. Martin. “These investments have strengthened our balance sheet as we approach key milestones in our antiviral clinical programs.”
The potential additional proceeds to the Company from the warrants, if fully exercised on a cash basis, will be approximately $1.83 million. No assurance can be given that any of these warrants will be exercised. The Company intends to use the net proceeds from this offering to support its clinical development programs, for working capital and general corporate purposes.
The unregistered securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Regulation D promulgated thereunder and have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered shares and shares of common stock issuable upon exercise of the warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create viable antiviral drugs.
Analysis of the data from the open-label pivotal trial of oxylanthanum carbonate (OLC) highlights that pill burden was significantly reduced in terms of both pill volume (7x) and pill count (2x) from pre-trial phosphate binder therapy
LOS ALTOS, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that it will present new oxylanthanum carbonate (OLC) data at the American Society of Nephrology (ASN) Kidney Week 2025, which will take place in Houston, TX, from November 5-9, 2025.
“Treatment with our investigational phosphate binder OLC led to clinically meaningful and statistically significant reductions in pill burden in terms of both volume and number of pills, giving us even more conviction about the potential benefits and convenience OLC may offer to patients,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “We look forward to offering OLC to chronic kidney disease (CKD) patients with hyperphosphatemia upon its approval as we diligently work to resubmit our New Drug Application by year-end.”
The open-label, single-arm, multicenter, multidose study enrolled 86 CKD patients on dialysis with mean historical serum phosphate ≥4.0 and ≤7.0 mg/dL for ≥8 weeks. 72 of these patients completed the study, and 70 had pretrial phosphate binder data. After washout from their prior phosphate binder, patients received OLC 500mg three times per day (TID), titrated to a maximum of 1000mg TID over 6 weeks, followed by a 4-week maintenance period. Pretrial phosphate binders included sevelamer carbonate, calcium acetate, ferric citrate and sucroferric oxyhydroxide. Results from the study will be shared in a poster titled “Oxylanthanum Carbonate Achieves Serum Phosphate Control with Significantly Lower Pill Burden in Dialysis Patients with Hyperphosphatemia” on Thursday, November 6 from 10:00 a.m. – 12:00 p.m. CT.
Key Findings:
The mean daily pill volume of pretrial binders at screening was 9.3 cm3, compared to a mean daily pill volume of binders at study end with OLC of 1.4 cm3 (Figure 1)
Ahead of enrolling in the trial, patients took a mean of 8.3 pills/day of phosphate binders, compared to a mean of 3.9 OLC pills/day at study end (Figure 1)
Serum phosphate was ≤5.5 mg/dL in 59% of patients at screening and in 91% of patients at the end of the OLC titration period
Figure 1:
“Reducing pill burden, in both of the number and volume of swallowed medication while improving phosphate control, represents a clinically meaningful innovation for the treatment of hyperphosphatemia in people with chronic kidney disease on dialysis,” said Dr. Pablo Pergola, MD, PhD, Research Director, Clinical Advancement Center, Renal Associates, P.A., and principal investigator of the trial. “This new analysis highlights the key benefits of this potentially transformative treatment that can become the new standard of care.”
The poster will be made available on the Presentations & Research page of Unicycive’s website following the poster presentation.
About Oxylanthanum Carbonate (OLC) OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden.
Unicycive is seeking Food and Drug Administration approval of OLC via the 505(b)(2) regulatory pathway. The New Drug Application submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.1 Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for chronic kidney disease (CKD) patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
1Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023;4(5):567-568. doi: 10.34067/KID.0000000000000145.
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 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, please visit Unicycive.com and follow us on LinkedIn and X.
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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
IDSA’s Recommendations Reinforce GeoVax’s Phase 2 Findings: Robust T-Cell Responses, Cross-Variant Durability, and Favorable Safety Profile in Vulnerable Populations
Atlanta, GA — October 29, 2025 — GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today emphasized how its recently presented Phase 2 clinical data for GEO-CM04S1, first reported at the World Vaccine Congress Europe 2025, align with the new Infectious Diseases Society of America (IDSA) guidelines prioritizing vaccination for immunocompromised individuals.
The IDSA guidance, issued October 17, 2025, concluded that existing COVID-19 vaccines provide only moderate and short-lived protection for immunocompromised patients – with effectiveness against hospitalization ranging from 33% to 56% and waning within two months. The panel called for new vaccine strategies tailored to vulnerable populations, including cancer patients, transplant recipients, and individuals receiving immunosuppressive therapies.
“Immunocompromised Americans are not a niche,” said David A. Dodd, Chairman & CEO of GeoVax. “They are cancer patients, transplant recipients, people with autoimmune disease, and those living with HIV – one in eight adults. They include family members, colleagues and neighbors. Yet mainstream vaccine approaches, heavily centered on mRNA, continue to leave them without durable protection. The new IDSA guidelines reinforce the urgent need for alternatives like GeoVax’s GEO-CM04S1.”
World Vaccine Congress – Data Provide Clinical Reinforcement
At the World Vaccine Congress Europe 2025 in Amsterdam, GeoVax scientific leaders presented new interim data from ongoing Phase 2 studies of GEO-CM04S1, the company’s multi-antigen, MVA-based COVID-19 vaccine designed for immunocompromised populations.
Key findings included:
Robust T-cell responses to both Spike and Nucleocapsid antigens, exceeding responses seen with mRNA boosters.
Broad, cross-variant immunity, including activity against Omicron subvariants.
Favorable safety profile, with only mild-to-moderate adverse events such as injection site reactions, fatigue, and myalgia; no vaccine-related serious adverse events reported.
In patients with hematologic malignancies post-transplant or CAR-T therapy, breakthrough infections were mild-to-moderate, underscoring the vaccine’s protective potential in highly vulnerable groups.
“These results, together with IDSA’s updated guidance, reinforce the critical need for vaccine platforms that move beyond antibody-only strategies,” said Dodd. “GEO-CM04S1 is designed to provide balanced immunity – antibodies plus durable T-cell responses – which are essential for the immunocompromised patients who remain most vulnerable despite existing vaccination campaigns. The convergence of these guidelines and our clinical findings underscores GEO-CM04S1’s potential to address one of the most critical gaps in COVID-19 prevention.”
GEO-CM04S1: A Vaccine Designed for the Immunocompromised
GeoVax’s GEO-CM04S1 is a multi-antigen, Modified Vaccinia Ankara (MVA)-based COVID-19 vaccine designed to elicit both antibody (humoral) and T-cell (cellular) immune responses. This dual-pathway activation is particularly important for patients who often fail to mount sufficient antibody responses with current mRNA vaccines, including cancer patients on chemotherapy, transplant recipients, and those receiving immunosuppressive therapies.
Key GEO-CM04S1 features include:
Multi-antigen breadth (Spike + Nucleocapsid proteins) – a design intended to provide broader immunologic coverage and to remain relevant as the virus continues to evolve.
Durable cellular immunity, critical where antibody responses are weak.
Alignment with IDSA priorities for transplant, cancer, autoimmune, and HIV patients.
Ongoing trials include Phase 2 studies as a primary vaccine for immunocompromised individuals, including post-transplant and hematologic cancer patients; and, as a booster for patients with chronic lymphocytic leukemia (CLL).
Interim results across these studies consistently demonstrate that GEO-CM04S1 can generate broader, more durable protection than mRNA vaccines, while maintaining a strong safety profile.
Breaking the Single-Platform Dependence
While mRNA vaccines were pivotal in the early pandemic response, their limitations in durability, breadth, and performance in immunocompromised populations highlight the risks of relying on a single platform. GEO-CM04S1 demonstrates how multi-antigen, T-cell–driven approaches can better protect high-risk populations and strengthen pandemic preparedness.
“Protecting the over 40 million immunocompromised Americans is both a moral imperative and a national security necessity,” added Dodd. “With positive clinical data and alignment with IDSA guidance, GeoVax is delivering a differentiated vaccine platform designed to serve those who need it most.”
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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. 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.
Cash runway into 2027, which is expected to support application resubmission, potential FDA approval, and launch of OLC
LOS ALTOS, Calif., Oct. 28, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the Company or Unicycive), today announced an update from its meeting with the U.S. Food and Drug Administration (FDA) and timing of the resubmission of its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) following receipt of a Complete Response Letter (CRL) on June 30, 2025. The Type A FDA meeting was held to discuss the resolution of the single deficiency identified in the CRL related to the compliance status of a third-party manufacturing vendor. No other concerns have been identified to the Company, including pre-clinical, clinical, or safety data submitted as part of the NDA. Following receipt of the official meeting minutes from the Type A meeting and engaging in discussions with its third-party manufacturing vendor, the Company plans to resubmit the NDA for OLC by year-end.
“We are grateful for the highly constructive feedback and detailed meeting minutes we received from the FDA and look forward to resubmitting the NDA as we advance OLC toward potential approval,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Following our interactions with the FDA, we are very encouraged about the potential for a swift resolution of the issue raised in our CRL and we believe we are now on track to resubmit our NDA before the end of the year, which could lead to a PDUFA date in the first half of 2026. With over $42 million on our balance sheet as of September 30, we have a cash runway into 2027, enabling us to work through the regulatory approval process and continue to advance preparations for potential OLC commercialization while focusing on our mission to deliver improved treatment options for patients with hyperphosphatemia on dialysis.”
About Oxylanthanum Carbonate (OLC) OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden. Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.1 Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
1Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145. Epub 2023 Jun 29. PMID: 37229723; PMCID: PMC10371371.
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 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.
Preliminary Financial Information The preliminary financial information included in this press release is unaudited and is subject to completion of the Company’s quarter-end closing procedures and further financial review. Actual results may differ from these estimates as a result of the completion of quarter-end closing procedures, review adjustments and other developments that may arise between now and the time such financial information for the period is finalized. As a result, these estimates are preliminary, may change and constitute forward-looking information and, as a result, are subject to risks and uncertainties. These preliminary estimates should not be viewed as a substitute for full financial statements prepared in accordance with United States generally accepted accounting principles, and they should not be viewed as indicative of our results for any future period. The Company’s independent registered public accountants have not audited, reviewed, compiled, or performed any procedures with respect to these estimated financial results and, accordingly, do not express an opinion or any other form of assurance with respect to these preliminary estimates.
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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to our ability to file an NDA before the end of 2025, risk that we do not get a PDUFA date in the first half of 2026; the accuracy of our cash on hand at September 30, 2025 and risk that our cash runway does not extend into 2027. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
BOTHELL, Wash., Oct. 27, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces it has received a Small Business Innovation Research (SBIR) Phase I award from the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID). This approximately $500,000 award will support the Company’s development of a novel, oral, broad-spectrum antiviral candidate for the treatment of influenza A and B infections. Cocrystal plans to utilize these funds to characterize lead candidate molecules that inhibit the target of the essential function of the influenza polymerase complex.
“This award provides non-dilutive funding to advance our influenza A/B program targeting potent, broad-spectrum drugs toward the path of clinical development,” said Sam Lee, PhD, Cocrystal President and co-CEO. “We appreciate the funding and confidence from NIH, which further validates our structure-based drug discovery platform technology in developing new antiviral treatments.”
The NIH/NIAID Phase I award is designed to assess the scientific, technical and commercial potential of early-stage programs. Successful completion of Phase I may qualify the recipient eligible to apply for a larger Phase II award, which provides additional substantial funding to continue development.
“We have prioritized the pursuit of government and military funding to advance our antiviral pipeline while building shareholder value,” said James Martin, Cocrystal CFO and co-CEO. “This is an important milestone as we continue our work to secure additional non-dilutive capital.”
The research is supported by the National Institute of Allergy and Infectious Diseases of the NIH under award number 75N93025C00038. The content of this news release is solely the responsibility of Cocrystal and does not necessarily represent the official views of the NIH.
Cocrystal Pharma’s Structure-Based Drug Discovery 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 identify novel binding sites and enables 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 novel broad-spectrum antivirals for the treatment of acute, chronic and potentially pandemic viral diseases.
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 to create viable antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the advancement of Cocrystal’s influenza A/B development program. 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, the risks and uncertainties arising from the U.S. government shutdown in October 2025 which may delay or prevent us from receiving funds described in this press release, potential manufacturing and research delays arising from raw materials and labor shortages and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors and our current and any future contract research organizations (CROs) and contract manufacturing organizations (CMOs), the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of the studies we undertake including any adverse findings or delays, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by governmental authorities and potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop and our liquidity needs. 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, 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.
