Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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WHO Has Declared Ebola A Public Health Emergency. On Sunday, May 17, the World Health Organization (WHO) declared Ebola a Public Health Emergency of International Concern (PHEIC), the highest level of global health alert it can issue. We believe the World Health Assembly in Geneva, Switzerland, held from May 18 to May 23, is increasing attention to outbreaks of Mpox, Ebola, and other infectious diseases. GeoVax is one of the few companies that has developed vaccines against these diseases.
GeoVax Has Overlooked Programs For Additional Infectious Diseases. GeoVax has completed pre-clinical work testing vaccines for hemorrhagic fever viruses, including Ebola, Sudan, and Marburg. It has developed these vaccines in collaborations with the National Institutes of Health, but has focused its resources on GEO-MVA, CM-04S1, and Gedeptin. The increased attention to Ebola could help obtain non-dilutive funding for these programs.
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*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.
WHO Emergency Declaration of Ebola Outbreak and Ongoing Mpox Developments Reinforce the Importance of Diversified Vaccine Supply and Scalable U.S.-Based Manufacturing Capabilities
ATLANTA, GA – May 18, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today highlighted the growing strategic importance of scalable domestic vaccine manufacturing infrastructure and diversified vaccine supply capabilities amid a series of escalating global infectious disease developments.
Recent public health events, including the World Health Organization’s declaration of a Public Health Emergency of International Concern (“PHEIC”) related to the ongoing Ebola outbreak involving the Bundibugyo strain, continued international spread of Clade I mpox, and recent hantavirus-related public health concerns, underscore the increasingly dynamic nature of global biodefense and pandemic preparedness requirements.
“These developments reinforce the importance of scalable and flexible vaccine preparedness infrastructure,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “GeoVax’s primary strategic focus remains the advancement of GEO-MVA, our Modified Vaccinia Ankara (MVA) mpox and smallpox vaccine candidate, which we believe is well aligned with growing global emphasis on diversified vaccine supply, domestic manufacturing capability, and long-term biodefense preparedness.”
GeoVax is advancing GEO-MVA to support global orthopoxvirus preparedness efforts and help address the need for expanded and diversified vaccine supply infrastructure. The Company recently announced positive Scientific Advice from the European Medicines Agency supporting a Phase 3 immunobridging pathway toward potential regulatory approval. This pivotal, Ph 3 trial is scheduled to initiate in Q4 ’26, with data results anticipated by mid-2027.
GeoVax believes recent infectious disease developments further reinforce the strategic importance of: • diversified vaccine supply infrastructure; • scalable domestic manufacturing capabilities; • rapid-response vaccine platform technologies; • and long-term investment in biodefense preparedness.
The Company also noted that the broader applicability of the MVA platform has been demonstrated across multiple infectious disease settings, including prior preclinical Ebola/hemorrhagic fever virus vaccine studies in which GeoVax’s MVA-based Ebola-Zaire vaccine candidate demonstrated complete protection in non-human primate lethal-challenge studies following Ebola virus exposure.
“Recent events continue to demonstrate that preparedness infrastructure cannot remain reactive or narrowly focused on individual outbreak cycles,” continued Mr. Dodd. “We believe the advancement of scalable domestic MVA-based manufacturing capability represents an important strategic objective for strengthening future biodefense readiness.”
About GEO-MVA
GEO-MVA is a next-generation Modified Vaccinia Ankara (MVA)-based vaccine candidate in development for the prevention of mpox and smallpox infection. GeoVax is advancing GEO-MVA as a potential differentiated MVA vaccine designed to support expanded global vaccine supply and diversified manufacturing capabilities. The program has received positive Scientific Advice from the European Medicines Agency supporting a Phase 3 immunobridging pathway toward potential regulatory approval.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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.
ATLANTA, GA – May 18, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies, today announced that it has entered into a securities purchase agreement with existing institutional investors for the purchase and sale of 2,027,027 shares of common stock (or common stock equivalents in lieu thereof) together with (i) Series A warrants to purchase up to 2,027,027 shares of common stock with an exercise price of $1.48 per share and a five-year term, and (ii) Series B warrants to purchase up to 2,027,027 shares of common stock with an exercise price of $1.48 per share and an 18-month term, for aggregate gross proceeds of approximately $3 million, before deducting placement agent fees and other offering expenses.
The closing of the offering is expected to occur on or about May 19, 2026, subject to the satisfaction of customary closing conditions. The Company expects to use the net proceeds from the offering for working capital and general corporate purposes.
A.G.P./Alliance Global Partners is acting as the sole placement agent in connection with the offering.
The offer and sale of the foregoing securities is being made in reliance on an exemption from the registration requirement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder, and applicable state securities laws, and the securities have not been and will not initially be registered under the Securities Act, or applicable state securities laws. Accordingly, the securities 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. Pursuant to the terms of the securities purchase agreement entered into with the investor, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the “SEC”) covering the resale of the shares of common stock and shares of common stock underlying common warrants sold in the offering.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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 GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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. Forward-looking statements include, among other things, statements regarding the proposed closing of the transaction, the expected gross proceeds and the intended use of proceeds. 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.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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1Q26 Report Included Milestones For FY2026. Eledon reported a Loss From Operations of $21.2 million, before interest income and a non-cash charge of $19.0 million from Changes in the Fair Value of Warrant Liabilities. This brought the 1Q26 Net Loss to $39.0 million or $(0.33) per share. The quarterly report confirmed our expectations for progress toward a Phase 3 trial in renal transplantation, as well as additional clinical trials in other organ transplants. Cash on March 31, 2026, was $111.1 million.
Several Clinical Milestones Are Expected For Renal Transplantation. We expect continued discussions with the FDA on the Phase 3 trial design and approval requirements. As discussed in our Research Note on February 2, additional long-term data from the Phase 1b trial were presented, with additional presentations of Phases 1b and 2 BESTOW extension data planned. We expect these studies to further support its safety profile and kidney function benefits.
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*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.
Completed enrollment in first cohort of Phase 1b challenge study evaluating CDI-988 as a preventive and as a treatment for norovirus infection, began enrollment in prevention and treatment cohorts
Highlighted CDI-988’s mechanism of action and clinical advancement at ICAR 2026
Granted FDA Fast Track designation for CDI-988, enabling the potential for an accelerated development pathway
Received initial $225,000 of SBIR NIH grant for influenza A and B antiviral lead generation
BOTHELL, Wash., May 15, 2026 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) provides updates on its antiviral product pipeline and business activities and reports financial results for the three months ended March 31, 2026.
“Advancing CDI-988 into a Phase 1b human challenge study is a pivotal milestone for the Company and a meaningful step in our clinical strategy. The study’s innovative design allows us to efficiently evaluate CDI-988 as a preventive and as a treatment for norovirus infection,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal Pharma. “We were pleased to receive FDA Fast Track designation for CDI-988, which speaks to the significant unmet need in norovirus and provides a potential pathway to accelerate our work to address a widespread and underserved public health burden.”
The ongoing Phase 1b randomized, double‑blind, placebo‑controlled challenge study (NCT07198139) is being conducted at Emory University School of Medicine in collaboration with the University of North Carolina. The study is designed to enroll up to 40 healthy adults, aged 18 to 49, in staged cohorts. The stage 1 infectivity cohort, now fully enrolled, will be followed by prevention and treatment cohorts in which CDI‑988 is administered at 1,200 mg twice daily for five days. The subjects in the prevention and treatment cohort have been enrolled. The primary efficacy endpoint is reduction in the incidence of clinical symptoms, with secondary endpoints including reduction in viral shedding, disease severity, safety and pharmacokinetics.
“We recently received the initial payment under our SBIR Phase I award, bringing in non-dilutive funding to advance our influenza A and B program toward clinical development,” said James Martin, CFO and co-CEO of Cocrystal Pharma. “The successful completion of this first phase could position us to compete for a larger Phase II award to support continued development. This award demonstrates our ongoing commitment to pursuing government and military funding to build and advance our antiviral pipeline.”
Antiviral Product Pipeline Overview
We leverage our proprietary structure-based drug discovery platform technology to develop next-generation, broad-spectrum antivirals that effectively block viral replication. Unlike other drug discovery approaches, our technology identifies compounds that bind to highly conserved regions of viral drug targets, including proteases and replication enzymes. By specifically targeting these essential viral functions, our drug candidates maintain efficacy 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. In addition, 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.
Norovirus Program Norovirus is a common, highly contagious virus that afflicts people of all ages and causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea, as well as fatigue, fever and dehydration. There are currently no effective treatments or vaccines for norovirus, and the ability to curtail outbreaks is inadequate.
Oral protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses: Our first oral direct-acting antiviral CDI-988 targets the highly conserved region of the 3CL protease and is designed as a potential therapeutic for noroviruses and coronaviruses. CDI-988 has shown in vitro activity against multiple norovirus strains.
In April 2025 we announced that CDI-988 showed superior broad-spectrum antiviral activity against the norovirus GII.17 strain, the most prevalent strain in the U.S. and Europe in 2024-2025.
In August 2025 we presented favorable Phase 1 safety and tolerability data from all CDI-988 doses, including a high-dose 1,200 mg cohort, at the 2025 Military Health System Research Symposium (MHSRS).
In September 2025 we discussed CDI-988’s scientific foundation and clinical progress in an oral presentation at the 9th International Calicivirus Conference, the leading calicivirus scientific meeting.
In September 2025 we received a Study May Proceed Letter from the FDA to conduct a Phase 1b challenge study in the U.S. evaluating CDI-988 as a norovirus preventive and treatment.
In March 2026 we enrolled the first subjects in our Phase 1b challenge study, which is being conducted at Emory University School of Medicine.
In April 2026 we announced full enrollment in the first cohort of the Phase 1b study, which is evaluating the infectivity rate of the GII.2 challenge inoculum, at the International Conference on Antiviral Research 2026 (ICAR 2026).
The subjects have been enrolled in the prevention and treatment cohort.
Influenza Programs Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Currently approved antiviral treatments for influenza are effective but are burdened with significant viral resistance.
CC-42344 is our novel PB2 inhibitor that showed excellent in vitro activity against pandemic and seasonal influenza A strains, as well as against strains that are resistant to Tamiflu® and Xofluza®.
Oral CC-42344 as a treatment for pandemic and seasonal influenza A
In December 2022 we reported favorable Phase 1 safety and tolerability results.
In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, and 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.
In May 2025 we reported that CC-42344 was shown to be active against the highly pathogenic 2024 Texas H5N1 avian influenza strain.
In November 2025 an initial Phase 2a study was completed, with CC-42344 showing a favorable safety and tolerability profile with no serious adverse events and no drug-related discontinuations by study participants. Efficacy analyses were not reported due to issues with trial conduct.
We plan to continue development of oral CC-42344 as a treatment for pandemic and seasonal influenza A with an additional Phase 2a study.
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.
We have developed a dry powder inhalation formulation of CC-42344 and have completed toxicology studies.
Influenza A/B program
In October 2025 we were awarded an approximate $500,000 Small Business Innovation Research (SBIR) Phase I grant from the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases to support the development of a novel, broad-spectrum lead candidate targeting the influenza A/B polymerase complex.
In the first quarter of 2026 we received $225,000 under the SBIR award.
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. CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. By the end of 2031, the global COVID-19 therapeutics market is estimated to exceed $16 billion annually.
Oral 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 pharmacokinetic properties.
In August 2025 we presented favorable safety and tolerability Phase 1 data from all CDI-988 doses, including a high-dose 1,200 mg cohort, at the MHSRS.
We are currently pursuing further development of CDI-988 as a preventive and treatment for norovirus infection and remain optimistic about its viability as a treatment for coronaviruses.
First Quarter Financial Results
Revenue for the first quarter of 2026 was $225,000, representing payments from an NIH SBIR award for an influenza A/B Inhibitor program. The Company reported no revenue for the first quarter of 2025.
Research and development expenses for the first quarters of 2026 and 2025 were $1.4 million. General and administrative expenses for the first quarter of 2026 were $1.2 million compared with $1.0 million for the first quarter of 2025, with the increase primarily due to an increase in legal and consultant costs, partially offset by a decrease in salaries and wages.
Net loss for the first quarter of 2026 was $2.3 million, or $0.17 per share on 13.8 million common shares outstanding, compared with a net loss for the first quarter of 2025 of $2.3 million, or $0.23 per share on 10.2 common shares outstanding.
Cocrystal reported unrestricted cash as of March 31, 2026, of $4.7 million compared with $7.7 million as of December 31, 2025. Net cash used in operating activities was $2.3 million for the three months ended March 31, 2026, compared with $2.9 million for the same period in 2025. The Company had working capital of $3.7 million as of March 31, 2026.
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 noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2) and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise 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 ongoing Phase 1b norovirus trial, our future potential for government grants, and the further development of our oral CC-42344 product candidate. 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 inflation, affordability, a deteriorating labor market, the possibility of a recession, increases or other developments with respect to interest rates, uncertainty surrounding the impacts arising from imposed and threatened tariffs and developments with respect thereto, and wars and geopolitical conflicts including those in Ukraine and with Iran on our Company, our collaboration partners, and on the U.S. 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 and test animals as well as similar problems with our vendors and our current and any future CROs and CMOs, the progress and results of the studies for CDI-988 and CC-42344 including issues with the initial Phase 2a study for CC-42344 which will prolong the development timeline of such product candidate, the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes and potential litigation challenging initiatives and actions taken by the Trump Administration which could, among other things, result in delays in regulatory approvals or limit access to federal funding for our programs, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, 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. 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, 2025. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Investor Contact: Alliance Advisors IR Bruce Voss [email protected] 310-691-7104
Includes Full Exercise of $15.0 million Over-Allotment Option
MALVERN, Pa., May 14, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced the closing of $130.0 million aggregate principal amount of 6.75% Convertible Senior Notes due 2034 (the “notes”) in a private offering (the “offering”) to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”), including the full exercise by the initial purchaser of its option to purchase an additional $15.0 million aggregate principal amount of the notes. The sale of the notes is expected to result in approximately $112.6 million in net proceeds to Ocugen after deducting the initial purchaser’s discount and estimated offering expenses payable by Ocugen.
The offering price of the notes was 90% of the principal amount of the notes. Ocugen used approximately $32.7 million of the net proceeds from the offering to fully repay the outstanding principal amount of, plus accrued and unpaid interest on, the loan outstanding under its Loan and Security Agreement with affiliates of Avenue Capital Group (the “Avenue Loan Agreement”), and pay the related prepayment fee and other fees and expenses in connection therewith. Ocugen expects to use the remaining net proceeds from the offering for general corporate purposes.
“This financing milestone reflects the strong momentum we have built across our late-stage pipeline and our unwavering commitment to the patients we serve,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-founder of Ocugen. “With our anticipated cash runway extended into 2028, we are well-positioned to advance three late-stage programs and execute toward our goal of filing three BLAs by 2028, bringing potentially transformative therapies to patients who have long awaited meaningful treatment options.”
AboutOcugen,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.
CautionaryNoteonForward-LookingStatements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including but not limited to, statements regarding the anticipated use of proceeds from the offering, Ocugen’s anticipated cash runway, the timing of future BLA filings, the potential to bring therapies to patients, and other statements contained in this press release that are not historical facts. Ocugen 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 Ocugen’s current expectations, including, but not limited to: risks related to the offering and uncertainties related to market conditions; the impact of the offering on the market price of Ocugen’s common stock; and risks related to the potential dilution to holders of Ocugen’s common stock. These and other risks and uncertainties are more fully described in Ocugen’s 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 Ocugen files with the SEC. Any forward-looking statements that Ocugen makes in this press release speak only as of the date of this press release. Except as required by law, Ocugen assumes 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.
Completed successful End-of-Phase 2 meeting with the FDA and selected onvansertib dose and chemotherapy regimen for planned Phase 3 trial
Company to provide detailed data update from Phase 2 CRDF-004 trial in rapid oral presentation at American Society of Clinical Oncology Annual Meeting
Leadership additions position Company to execute on key upcoming clinical and regulatory milestones
SAN DIEGO, May 14, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced financial results for the first quarter ended March 31, 2026, and provided a business update.
“This quarter was marked by the positive data update from our randomized Phase 2 CRDF-004 trial of onvansertib in first-line RAS-mutated metastatic colorectal cancer, along with key leadership additions that prepare the Company to deliver on the clinical milestones ahead,” said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology.
“In April, we had a successful End-of-Phase 2 meeting with the FDA and aligned on the key design elements for our Phase 3 registrational trial. We plan to share additional Phase 3 details and our regulatory strategy in mid-2026. At the upcoming ASCO Annual Meeting, we will present updated CRDF-004 data, which we believe will provide further insight into onvansertib’s potential in the first-line RAS-mutated metastatic colorectal cancer (mCRC) setting. In parallel, we continue to strengthen the scientific foundation of our PLK1 inhibition strategy, supported by new preclinical data evaluating combination use with an antibody-drug conjugate, as well as ongoing single-agent and combination investigator-initiated studies across multiple cancer settings. With strong clinical momentum, we remain focused on disciplined execution throughout the year.”
Clinical Highlights
Upcoming Event: Reporting Updated Onvansertib Data in Rapid Oral Presentation at American Society of Clinical Oncology (ASCO) Annual Meeting 2026
The Company will report detailed updated data from its randomized Phase 2 CRDF-004 trial evaluating onvansertib in combination with FOLFIRI/bev or FOLFOX/bev in patients with first-line RAS-mutated mCRC in a rapid oral presentation at the ASCO Annual Meeting, taking place May 29–June 2 in Chicago. More information about the presentation is available here.
Completed End-of-Phase 2 Meeting with the FDA and Aligned on the Design of the Phase 3 Registrational Trial in Patients with First-line RAS-mutated mCRC
In consultation with the U.S. Food and Drug Administration (FDA), Cardiff selected the 30 mg dose of onvansertib for evaluation with FOLFIRI/bev chemotherapy regimen for the Phase 3 trial in patients with first-line RAS-mutated mCRC. Additional details of the clinical trial will be shared by mid-2026.
Key Opinion Leader Engagements Highlight Onvansertib Clinical Data and Opportunity in mCRC
In March, Cardiff hosted a KOL webinar featuring internationally recognized leaders in colorectal cancer research, Drs. Scott Kopetz and Heinz-Josef Lenz. The webinar focused on the evolving treatment landscape in first-line RAS-mutated mCRC and onvansertib’s potential as a novel therapeutic approach in the management of RAS-mutated mCRC. A replay of the webcast is available in the Events section of the Company’s website.
Announced Positive Update from our Randomized Phase 2 Trial of Onvansertib in First-line RAS-mutated mCRC
In January, Cardiff provided topline data from its ongoing CRDF-004 Phase 2 randomized clinical trial in first-line RAS-mutated mCRC. The 30 mg onvansertib + FOLFIRI/bevacizumab (bev) arm achieved a confirmed objective response rate (ORR) of 72.2% compared to 43.2% across the combined standard-of-care (SoC) arms. The 30 mg onvansertib dose in combination with FOLFIRI/bev also demonstrated marked improvement in progression-free survival (PFS) versus FOLFIRI/bev (HR: 0.38) and combined SoC of FOLFOX/bev and FOLFIRI/bev (HR: 0.37, p<0.05), with no significant added toxicity observed. More details available here.
Preclinical Highlights
Company Presented New Preclinical Data at the 2026 American Association for Cancer Research (AACR) Annual Meeting Supporting Rationale for Onvansertib in Combination with Antibody Drug Conjugates
Cardiff presented new preclinical data at the AACR Annual Meeting in April demonstrating that onvansertib enhanced the activity of the HER2-targeted antibody-drug conjugate trastuzumab deruxtecan (T-DXd), driving tumor regression and overcoming resistance in HER2-low breast cancer models. More details are available here.
Corporate Update
Key Leadership Appointments Strengthen Executive Team to Support Company’s Next Phase of Growth
In April, the Company announced the appointment of Mani Mohindru, PhD, as President and Chief Executive Officer (CEO), following her time as Interim CEO. She will continue as a member of the Board of Directors. The Company also appointed Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, MBA, as Chief Operating Officer, effective April 6 and April 27, respectively. Together, these appointments reflect Cardiff’s commitment to building an experienced leadership team to advance onvansertib and deliver on the program’s long-term potential.
First Quarter 2026 Financial Results
Liquidity, cash burn, and cash runway
As of March 31, 2026, Cardiff Oncology had approximately $46.1 million in cash, cash equivalents, and short-term investments.
Net cash used in operating activities for the first quarter of 2026 was approximately $12.3 million, a decrease of approximately $0.5 million from $12.8 million for the same period in 2025.
Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into the first quarter of 2027.
Operating results
Total operating expenses were approximately $12.9 million for the three months ended March 31, 2026, a decrease of $1.6 million from $14.5 million for the same period in 2025. The decrease in operating expenses was primarily due to a decrease of $3.7 million in R&D expenses, mainly clinical trial expenses and preclinical activities, partially offset by an increase of $2.1 million in SG&A expenses, primarily for employee severance agreements and corresponding modifications of stock options.
About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.
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 Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’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 candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; 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. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
BERKELEY HEIGHTS, N.J., May 14, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced a poster presentation at ISPOR 2026, the Professional Society for Health Economics and Outcomes Research’s annual meeting, being held May 17-20, 2026, in Philadelphia, Pennsylvania. The retrospective cohort study utilized U.S. claims data from April 2021-April 2024 to analyze adults with fibromyalgia. TONMYA® (cyclobenzaprine HCl sublingual tablets) was approved by the U.S. FDA on August 15, 2025, and commercially launched in the U.S. on November 17, 2025.
Poster Presentation Details
Title: Characterizing Patients with Fibromyalgia: A U.S. Real-World Claims Analysis Poster #: RWD167 Poster Session: 5 Date: Wednesday, May 20, 2026 Time: 9:00-11:30 a.m. ET Presenter: William Olsufka, PharmD, Tonix Medicines, Inc.
After the presentation, a copy of poster will be available under the Scientific Presentations tab on the Tonix website at https://www.tonixpharma.com/.
About Fibromyalgia Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts more than 10 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.
About TONMYA® (cyclobenzaprine HCl sublingual tablets) TONMYA (cyclobenzaprine HCl sublingual tablets) is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TONMYA was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. TNX-102 SL is also being developed to treat acute stress disorder (ASD)/acute stress reaction (ASR), and major depressive disorder (MDD). The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TONMYA composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034/2035.
Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD154/CD40 ligand (CD40L) inhibitor for the prevention of kidney transplant rejection. In addition, Tonix is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. To learn more, visit www.tonixpharma.com.
*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. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.
Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. 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 in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. 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.
100% insulin independence achieved in 10 patients with type 1 diabetes treated with tegoprubart following islet transplantation in UChicago Medicine-led study
FDA Orphan Drug designation granted to tegoprubart for the prevention of allograft rejection in liver transplantation
Cash, cash equivalents and short-term investments totaled $111.1 million as of March 31, 2026
IRVINE, Calif., May 13, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its first quarter 2026 operating and financial results and provided recent business highlights.
“In the first quarter of 2026, we achieved significant milestones in our tegoprubart program, including important data updates in kidney and islet cell transplantation and FDA Orphan Drug designation for tegoprubart in liver transplantation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Looking ahead, we expect multiple catalysts in 2026, including regulatory engagements supporting the advancement of tegoprubart into Phase 3 development in kidney transplantation and discussions regarding a potential path to market in islet cell transplantation. We also plan to initiate several new clinical trials, including an investigator sponsored study in liver transplantation, and share new kidney transplant data from our Phase 2 BESTOW long-term extension study, building on encouraging 24-month Phase 1b results that demonstrated a durable safety profile and improved graft function.”
First Quarter 2026 Business Highlights
In March 2026, announced updated results from an ongoing investigator-led trial at the University of Chicago Medicine Transplant Institute evaluating tegoprubart in 12 adults with high-risk type 1 diabetes undergoing allogenic islet transplantation. All 10 patients who are more than four weeks post-transplant achieved 100% insulin independence. There were no signs of graft rejection or de novo donor-specific HLA antibodies and no evidence of nephrotoxicity, hypertension, or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, the current standard of care.
The U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to tegoprubart for the prevention of allograft rejection in liver transplantation.
Presented 24-month follow-up data from eight patients enrolled in the Phase 1b trial long-term extension trial evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium in January 2026. Results showed there were no episodes of biopsy-proven acute rejection, graft loss, death, new-onset diabetes mellitus, or de novo donor-specific antibody formation during the study period. Mean estimated glomerular filtration rate (eGFR) increased over the measurement period, from 67.0 mL/min/1.73 m2 at 12 months to 74.2 mL/min/1.73 m2 at 24 months.
2026 Anticipated Upcoming Milestones
Receive FDA guidance on the Phase 3 trial design assessing tegoprubart in kidney transplantation, followed by initiation of the Phase 3 trial pending regulatory alignment.
Report long-term data from Phase 1b and Phase 2 BESTOW studies evaluating tegoprubart in kidney transplantation.
Receive FDA regulatory guidance on the path to market for tegoprubart in islet cell transplantation and xenotransplantation.
Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients with renal dysfunction receiving an islet cell transplant.
Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo liver transplant.
Initiate an investigator-led study evaluating tegoprubart for kidney transplant tolerance induction.
First Quarter 2026 Financial Results
Cash, cash equivalents and short-term investments totaled $111.1 million as of March 31, 2026, compared to $133.3 million as of December 31, 2025. The company expects current cash, cash equivalents and short-term investments to fund operations into 2Q 2027.
Research and development (R&D) expenses for the first quarter of 2026 were $17.2 million, including $1.1 million of non-cash stock-based compensation expense, compared to $13.5 million, including $1.0 million of non-cash stock-based compensation expense, for the comparable period in 2025.
General and administrative (G&A) expenses for the first quarter of 2026 were $4.0 million, including $1.1 million of non-cash stock-based compensation expense, compared to $4.4 million, including $1.8 million of non-cash stock-based compensation expense, for the comparable period in 2025.
Net loss for the first quarter of 2026 was $39.0 million, or $0.33 per basic common share, compared to a net loss of $6.5 million, or $0.08 per basic common share, for the comparable period in 2025. Net loss in the first quarter of 2026 included a non-cash loss of $19.0 million from changes in the fair value of warrant liabilities, while the 2025 net loss included a non-cash gain of $10.1 million from such changes. Excluding the non-cash items related to changes in the fair value of warrant liabilities, Eledon would have recorded a net loss of $20.1 million for the three months ended March 31, 2026, and $16.6 million for the three months ended March 31, 2025.
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, islet cell transplantation, liver transplantation 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; X
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: our short operating history and shifts in our business strategy; our operating losses since inception; our need for additional funding to develop our lead drug candidate and our ability to secure additional funding on acceptable terms or at all; the impact of issuances of our common stock, including in the possibility of dilution or a decline in our stock price; our ability to successfully develop our product candidates; unfavorable global economic and financial market conditions; the regulatory environment of our business and our ability to obtain required regulatory approvals; results of non-clinical studies and clinical trials, and risks that non-clinical studies or early clinical trials may not be predictive of results of later-stage clinical trials; delays or difficulties in enrollment of patients in clinical trials; our ability to attract and retain our executives and key employees; legislation of the pharmaceutical and healthcare industries; cybersecurity and data privacy risks; the ability of our products to achieve marketing approval; competition in our industry; our ability to obtain
insurance coverage; our dependence on contract research organizations; our ability to protect our intellectual property; public health crises; our ability to maintain proper and effective internal control over financial reporting and other risks disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 19, 2026. 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 materially from the forward-looking statements contained herein, are discussed in our 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.
Company Expands Strategic Immuno-Oncology Positioning Around Tumor Microenvironment Modulation, Checkpoint Enhancement, and Multi-Tumor Development Potential
ATLANTA, GA – May 13, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines for solid tumors and infectious diseases, today highlighted the expanding strategic relevance of its Gedeptin® immuno-oncology program within the rapidly evolving landscape of combination immunotherapy and checkpoint inhibitor enhancement strategies.
GeoVax believes Gedeptin’s unique mechanism of localized tumor destruction combined with immune activation positions the program within a growing area of oncology focus: therapies designed to overcome immune resistance and enhance responsiveness to checkpoint inhibitors in immunologically “cold” tumors.
Checkpoint inhibitors targeting PD-1 and PD-L1 have transformed cancer treatment across multiple tumor types; however, many solid tumors remain insufficiently responsive due to immune-suppressive tumor microenvironments, inadequate immune-cell infiltration, and incomplete tumor antigen recognition. As a result, oncologists are increasingly focused on combination approaches capable of improving checkpoint inhibitor response rates and extending durability of benefit.
“Modern immuno-oncology is increasingly shifting toward combination strategies designed to improve the effectiveness of checkpoint inhibitors across broader patient populations,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “We believe Gedeptin aligns directly with this trend by functioning not simply as a localized tumor therapy, but as a potential immune-sensitization platform capable of enhancing anti-tumor immune responses in tumors where checkpoint inhibitors alone may be insufficient.”
Key characteristics of the Gedeptin platform include:
Tumor-agnostic mechanism of action independent of tumor histology or proliferation rate;
Strong bystander effect, allowing destruction of neighboring tumor cells even when only a fraction are directly transduced;
Tumor microenvironment remodeling and immune activation, potentially enhancing tumor recognition by the immune system;
Potential checkpoint sensitization, supporting combination strategies with PD-1 and PD-L1 inhibitors;
Compatibility with image-guided and intratumoral delivery approaches across multiple solid tumor settings.
GeoVax’s lead development focus for Gedeptin is a planned neoadjuvant combination study in recurrent head and neck squamous cell carcinoma (HNSCC), evaluating intratumoral Gedeptin together with PD-1 targeting immunotherapy in patients eligible for curative-intent surgery. The study is expected to evaluate pathologic response, immune biomarker modulation, and early event-free survival signals.
“The oncology field is increasingly recognizing that durable checkpoint inhibitor responses may require direct modulation of the tumor microenvironment in addition to checkpoint blockade alone,” continued Mr. Dodd. “We believe Gedeptin’s ability to induce localized tumor destruction while simultaneously promoting immune activation creates a compelling rationale for combination development approaches designed to broaden and deepen immunotherapy responses. Importantly, we believe this mechanism may ultimately extend beyond localized disease settings and support broader applicability across metastatic solid tumors where immune resistance remains a major therapeutic challenge.”
Beyond head and neck cancer, GeoVax believes Gedeptin may have broader applicability across solid tumors characterized by:
established checkpoint inhibitor treatment paradigms,
and at least one lesion amenable to intratumoral or image-guided delivery.
Potential future tumor targets under evaluation include melanoma, triple-negative breast cancer, cutaneous malignancies, and additional metastatic solid tumor settings.
“As the oncology landscape evolves beyond single-agent checkpoint inhibition toward increasingly sophisticated combination approaches, we believe therapies capable of enhancing immune recognition and overcoming tumor resistance mechanisms may become increasingly important,” added Mr. Dodd. “Our objective is to position Gedeptin within that emerging therapeutic landscape as a differentiated immune-enabling platform with potential applicability across multiple solid tumor indications.”
About Gedeptin®
Gedeptin® is GeoVax’s proprietary gene-directed enzyme prodrug therapy (GDEPT) platform under development for the treatment of solid tumors. The therapy is designed for intratumoral administration and utilizes a non-replicating adenoviral vector to deliver purine nucleoside phosphorylase (PNP) directly into tumor tissue. Following administration of fludarabine, the PNP enzyme converts the prodrug into a potent localized cytotoxic agent that destroys tumor cells while simultaneously generating immune-activating signals within the tumor microenvironment.
GeoVax is advancing development plans to evaluate Gedeptin in combination with immune checkpoint inhibitors, including pembrolizumab, with the goal of amplifying anti-tumor immune activation and broadening therapeutic applicability across multiple solid tumor indications.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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.
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.
First Quarter Operating Loss Was Lower Than Our Estimates. Unicycive reported a 1Q Loss From Operations of $8.0 million, compared with our estimate of $9.9 million. An increase of $8.3 million in the Fair Value of Warrant Liabilities resulted in a Net Comprehensive Loss attributable to common shareholders of $12.8 million, or $(0.54) per share. Importantly, the company confirmed that NDA approval for OLC is on track to meet the June 29 PDUFA date. Cash on March 31, 2026, was $57.1 million.
We Expect OLC Approval By The PDUFA Date. The NDA for OLC (oxylanthanum calcium) was submitted in December and accepted for review in January. We believe the preclinical and clinical sections have already passed FDA review, and previous manufacturing problems associated with a contract manufacturer have been corrected. We expect OLC to receive FDA approval on or before its June 29, 2026, approval date.
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*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.
SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) — Gyre Therapeutics, Inc. (“Gyre”, “Gyre Therapeutics” or the “Company”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company with operations in the United States and China, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for F351 (hydronidone) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). The acceptance comes after the NMPA previously granted priority review status for F351 in March after Gyre submitted the NDA through its majority-owned subsidiary Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals). This marks the second major product for which Gyre has submitted an NDA to the NMPA, and is a significant milestone for the Company in the commercialization of a new medication for the treatment of CHB-induced liver fibrosis.
Dr. Ying Luo, President and Chief Executive Officer of Gyre, commented, “This is another significant achievement for Gyre. This NDA is our third submission accepted for review by the NMPA, and the first one for our F351 program. Our interactions with the CDE have been very positive to date, reinforcing the agency’s support for addressing the medical need to treat liver fibrosis and the potential of F351 as an innovative therapeutic option. If approved, F351 could address the tens of millions of patients in China with HBV infection, many of whom will develop liver fibrosis and potentially cirrhosis. We look forward to working closely with CDE to progress F351 towards commercial approval.”
About Priority Review Designation by the NMPA in China
Priority review was established in China in 2017 to facilitate drug registration and accelerate the development of new drugs with clinical value under the guidance of Opinions on Encouraging Pharmaceutical Innovation via Priority Review & Approval. According to these guidelines, the NMPA will prioritize the review of these applications and allocate additional evaluation resources, which is expected to accelerate the review process.
About F351 (hydronidone)
F351 is Gyre’s lead development candidate for the treatment of liver fibrosis that is being developed for two different indications. It is a structurally modified derivative of pirfenidone designed to optimize metabolic properties while targeting the TGF-β1 signaling pathway, a key mediator of fibrogenesis. Gyre is developing F351 for two primary indications: Chronic hepatitis B (CHB)-associated liver fibrosis in the People’s Republic of China (PRC) and MASH-associated liver fibrosis initially in the United States.
In the United States, Gyre has completed a Phase 1 clinical trial in healthy volunteers evaluating F351’s safety, tolerability, and PK. Gyre plans to file an Investigational New Drug (IND) application in the U.S. by the end of 2026, and, if the IND becomes effective, to initiate a Phase 2 clinical trial.
About CHB-Induced Liver Fibrosis
Liver fibrosis is a condition where healthy tissues in the liver become scarred in response to chronic inflammation. If left untreated, it can progress to cirrhosis—the final, severe stage where extensive scarring permanently distorts the liver’s architecture and significantly impairs its vital functions. Viral hepatitis is estimated to cause up to 50% of fibrosis and 65% of cirrhosis worldwide. Without intervention, liver fibrosis and cirrhosis typically progress from manageable organ damage to systemic, life-threatening liver failure and hepatocellular carcinoma (HCC). No non-viral directed therapy has been shown to reduce fibrosis in viral induced hepatitis.
About Gyre Pharmaceuticals
Gyre Pharmaceuticals Co., Ltd., a subsidiary of Gyre Therapeutics, Inc., is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY™ (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share over the past several years. In addition, Gyre Pharmaceuticals’ pipeline includes F351 (hydronidone), a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. F351 received Breakthrough Therapy designation by the CDE of the NMPA in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. As of March 31, 2026, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals.
About Gyre Therapeutics
Gyre Therapeutics is a commercial-stage biopharmaceutical company headquartered in San Diego, CA focused on the development and commercialization of small-molecule therapeutics with its most advanced programs addressing organ fibrosis and inflammatory diseases.
Gyre’s wholly-owned subsidiary, Cullgen Inc., is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader and degrader-antibody conjugate (DAC) therapies for critical conditions including cancer and inflammatory diseases. Cullgen has created a portfolio of highly selective targeted protein degrader and DAC product candidates designed to potently and efficiently eliminate therapeutically relevant proteins in patients.
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 development and commercial potential and potential benefits of F351; the timing and progression of commercial approval of F351; and the timing of Gyre’s IND application in the U.S., and, if the IND becomes effective, initiation of a Phase 2 clinical trial 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: unexpected costs, charges or expenses resulting from the acquisition; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the acquisition; the risk that the combined company may not be able to successfully integrate the businesses and realize the expected benefits of the acquisition in a timely manner or at all; the uncertainties associated with Gyre’s and Cullgen’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; risks related to the inability of the combined entity to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks associated with the possible failure to realize certain anticipated benefits of the acquisition, including with respect to future financial and operating results. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2025 filed on March 13, 2026, and in other filings 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.
U.S. Food and Drug Administration (FDA) review of oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission remains on track, with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026
Commercial readiness activities continue in anticipation of the potential commercial launch of OLC
MOUNTAIN VIEW, Calif., May 12, 2026 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the first quarter ended March 31, 2026, and provided a business update.
“As we approach the June 29th PDUFA target action date, we remain optimistic about the potential approval of OLC and focused on preparations for the subsequent launch of OLC,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Our ongoing dialogue with the FDA during the review cycle has been constructive and timely. Uncontrolled hyperphosphatemia remains a significant health concern, affecting nearly 75% of U.S. patients with chronic kidney disease who are undergoing dialysis. OLC has the potential to improve adherence and phosphorus control with reduced pill burden, compared with currently available phosphate binders.”
Key Highlights & Upcoming Milestones
In January 2026, the Company announced the FDA accepted the resubmission of its NDA for OLC, an investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with CKD on dialysis. The FDA set a PDUFA target action date of June 29, 2026. The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study in patients with CKD on dialysis), multiple preclinical studies, and chemistry, manufacturing, and controls (CMC) data. The FDA did not raise any concerns regarding the preclinical, clinical, or safety data for OLC included in the original NDA submission. The December 2025 resubmission was based on progress made by the third-party manufacturing vendor responsible for the drug product.
In preparation for a potential launch of OLC later this year, the Company continues to strengthen its commercial infrastructure and advance market readiness initiatives. Unicycive’s goal is to optimize patient access across all reimbursement settings and intends to provide dedicated access and reimbursement support services for all patients through Unicycive’s UniSource™ reimbursement hub.
Financial Results for the Quarter Ended March 31, 2026
As of May 11, 2026, unaudited cash, cash equivalents, and marketable securities totaled $57.1 million. The Company believes that it has sufficient resources to fund planned operations into 2027.
Research and Development (R&D) expense were $1.6 million for the quarter ended March 31, 2026, compared to $2.2 million for the three months ended March 31, 2025. The decrease in research and development expense was primarily attributed to a decrease in drug development costs as well as consulting and professional fees.
General and Administrative (G&A) expense were $6.8 million for the quarter ended March 31, 2026, compared to $5.8 million for the three months ended March 31, 2025. The increase was primarily attributed to an increase in consulting, professional services, and labor costs.
Other income (expense) was $(4.4) million for the quarter ended March 31, 2026, compared to $8.6 million income for the three months ended March 31, 2025, attributed primarily to an increase in the fair value of the Company’s warrant liability.
Net comprehensive income (loss) attributable to common stockholders, basic for the quarter ended March 31, 2026, was $(12.8) million, or $(0.54) per share of common stock, compared to $0.5 million income, or $0.04 per share of common stock, for the three months ended March 31, 2025. Net comprehensive income (loss) attributable to common stockholders, diluted for the quarter ended March 31, 2026, was $(12.8) million, or $(0.54) per share of common stock, compared to $(6.2) million, or $(0.50) per share of common stock, for the three months ended March 31, 2025. The increased net loss for the quarter ended March 31, 2026, was attributed primarily to an increase in the fair value of the Company’s warrant liability.
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, 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; our dependence on third parties for manufacturing; 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; market acceptance of our products; 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, 2025, 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.
