Tag: Biotechnology

Release – MAIA Biotechnology Announces Publication of Interim Clinical Data on Telomere Targeting Anticancer Agent in Peer-Reviewed Journal Cells

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

August 27, 2025 9:01am EDT Download as PDF

CHICAGO, Aug. 27, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that a manuscript detailing developments in its Phase 2 THIO-101 clinical trial was accepted and published in the international peer-reviewed open access scientific journal, Cells, in a special issue, “Cellular Mechanisms of Anti-Cancer Therapies”

The manuscript, titled “Perioperative Management of Non-Small Cell Lung Cancer in the Era of Immunotherapy,” was authored by a group of oncology researchers in Turkey and the U.S. including MAIA scientists Sergei Gryaznov, Ph.D., Chief Scientific Officer and Ilgen Mender, Director of Biology Research, along with MAIA Scientific Advisory Board members Z. Gunnur Dikmen, M.D., Ph.D. and Saadettin Kiliçkap, M.D., M.Sc.

MAIA Chairman and CEO Vlad Vitoc, M.D. commented, “The importance of the findings published in Cells cannot be overstated. While conventional immunotherapies have expanded treatment options for patients, intrinsic and acquired resistance by patients remains a challenge. Our novel combination strategy of ateganosine sequenced with a checkpoint inhibitor stands out, showing encouraging results in a population with high unmet medical need.”

About Cells
Cells (ISSN 2073-4409) is an international, peer-reviewed, open access journal which provides an advanced forum for studies related to cell biology, molecular biology and biophysics. It publishes reviews, research articles, communications and technical notes. Cells is an MDPI (Multidisciplinary Digital Publishing Institute) publication.

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

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

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

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

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Source: MAIA Biotechnology, Inc.

Released August 27, 2025

Release – GeoVax Announces Allowance of Patent Protecting Multi-Antigen COVID-19 Vaccine Constructs

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

    Expands Intellectual Property Portfolio Supporting Next-Generation COVID-19 Vaccine Candidates

    ATLANTA, GA, August 20, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 17/888,131, titled “Vaccines and Uses Thereof to Induce an Immune Response to SARS-CoV-2.”

    The allowed claims broadly cover recombinant Modified Vaccinia Ankara (MVA) viral vectors encoding multiple SARS-CoV-2 proteins – including Spike (S), Membrane (M), and Envelope (E) antigens – configured to generate virus-like particles (VLPs) upon expression. These constructs are designed to induce both antibody and T-cell responses, providing durable and broad immune protection against current and emerging variants of SARS-CoV-2.

    Key features of the allowed claims include:

    • Multi-antigen design (Spike, Membrane, and Envelope proteins) to mimic the natural virus structure and induce robust immune responses.
    • VLP formation within host cells, enabling presentation of antigens in their natural conformation for optimal immune recognition.
    • Coverage of both ancestral strain sequences and variant-associated mutations (e.g., K417N/T, E484K, N501Y) to address immune escape.

    David Dodd, GeoVax President and CEO, commented: “This Notice of Allowance represents an important strengthening of our intellectual property estate protecting our next-generation, multi-antigen COVID-19 vaccines. Unlike single-antigen vaccines, our MVA-based multi-antigen constructs are designed to elicit durable, broad-spectrum protection – even as the virus continues to evolve.”

    About GeoVax’s Multi-Antigen COVID-19 Vaccine Portfolio

    GeoVax is pioneering a differentiated, multi-antigen approach to COVID-19 vaccination. The newly allowed patent broadly covers constructs central to the Company’s CM01 and CM02 candidates, which express multiple SARS-CoV-2 proteins to generate virus-like particles (VLPs) in vaccinated individuals. These vaccine designs are intended to provide broad and durable protection by engaging both arms of the immune system and countering immune escape by new viral variants.

    Together with GEO-CM04S1, which is advancing through Phase 2 clinical trials in immunocompromised and healthy populations, CM01 and CM02 give GeoVax what CEO David Dodd describes as “the corner on the multi-antigen space.” This combined portfolio underscores GeoVax’s position as a leader in next-generation COVID-19 vaccine innovation, uniquely differentiated from single-antigen approaches such as mRNA vaccines.

    About GeoVax

    GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

    Forward-Looking Statements

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

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

    Company Contact:

    info@geovax.com

    678-384-7220

    Media Contact:

    Jessica Starman

    media@geovax.com 

    Release – Unicycive Therapeutics Granted New U.S. Patent for UNI-494 to Treat Chronic Kidney Disease

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on UNCY

    August 18, 2025 7:05am EDT Download as PDF

    Ensures Intellectual Property Protection Until 2040

    LOS ALTOS, Calif., Aug. 18, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the issuance of U.S. Patent 12,377,082 by the U.S. Patent and Trademark Office for UNI-494 to treat Chronic Kidney Disease (CKD). This patent follows the issuance of an earlier method of use patent for the treatment of Acute Kidney Injury with UNI-494.

    “While we are focused on seeking FDA approval of our lead product oxylanthanum carbonate, we are pleased to announce the issuance of another patent for our second investigational drug, UNI-494,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “This patent is part of a broader intellectual property portfolio for UNI-494, which supports potential partnership opportunities and future development efforts. We have completed a Phase I clinical study in healthy volunteers and have received Orphan Drug Designation for the prevention of delayed graft function (DGF) in patients undergoing kidney transplantation.”

    About UNI-494
    UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide. UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients. UNI-494 has completed a Phase 1 dose-ranging safety study in healthy volunteers.

    About Acute Kidney Injury
    Acute kidney injury (AKI) is defined as a sudden loss of kidney function that is determined based on increased serum creatinine levels and decreased urine output and is limited to a duration of 7 days. The primary causes of AKI include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a type of acute kidney injury that occurs in the first week after kidney transplantation. AKI is estimated to occur in 20-200 per million population in the community, 7-18% of patients in the hospital and approximately 50% of patients admitted to the intensive care unit. Importantly AKI is associated with morbidity and mortality; an estimated 2 million people die of AKI worldwide every year whereas survivors of AKI are at increased risk of chronic kidney disease and end stage renal disease.

    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 for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.

    Forward-looking statements
    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Investor Contacts:

    Kevin Gardner
    LifeSci Advisors
    kgardner@lifesciadvisors.com

    Media Contact:

    Rachel Visi
    Real Chemistry
    redery@realchemistry.com

    SOURCE: Unicycive Therapeutics, Inc.

    Release – Eledon Pharmaceuticals Reports Second Quarter 2025 Operating and Financial Results

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on ELDN

    August 14, 2025

    PDF Version

    Updated data from ongoing open-label Phase 1b trial demonstrated a mean 12-month eGFR of approximately 68 mL/min/1.73 m2 post-transplant for patients on tegoprubart

    Company on track to report topline results from Phase 2 BESTOW trial in kidney transplantation in November 2025

    Cash, cash equivalents and short-term investments of $107.6 million as of June 30, 2025

    IRVINE, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its second quarter 2025 operating and financial results and reviewed recent business highlights.

    “We are proud to enter the second half of the year with strong momentum as we have achieved all of our key milestones to date including advancing tegoprubart in kidney, islet cell (type 1 diabetes), and liver allotransplantation, as well as in xenotransplantation. The positive data we recently presented at the World Transplant Congress reinforce the potential of tegoprubart to improve long-term transplant outcomes while reducing the toxic side effects often associated with the current standard of care,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “With these encouraging results in hand, we look forward to sharing topline data later this year from our Phase 2 BESTOW trial in kidney transplantation and to continuing to explore tegoprubart’s broad potential in other transplant indications.”

    Year-to-Date 2025 Business Highlights

    • Presented updated data at the World Transplant Congress (WTC) in August 2025 from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Updated data from 32 participants demonstrated that tegoprubart continues to be well tolerated with no cases of death, graft loss, drug related tremor, sepsis, or new-onset diabetes. Kidney function, as assessed by estimated glomerular filtration rate (eGFR), generally stabilized after the first month post-transplant and remained in the range of approximately 68 mL/min/1.73 m2 through 12 months for participants (n=12) who remained on tegoprubart. For comparison, data from historical studies using the standard of care, calcineurin inhibitor-based immunosuppression therapy, typically report aggregate mean eGFRs of approximately 53 mL/min/1.73 m2 at 12 months after kidney transplant.
    • In June 2025, a third patient was treated with tegoprubart as a cornerstone component of the immunosuppression treatment regimen following kidney xenotransplantation conducted at Massachusetts General Hospital (MGH) in collaboration with eGenesis.
    • Announced the first three islet cell transplant recipients treated at the University of Chicago Medicine’s Transplant Institute in an investigator-initiated trial evaluating tegoprubart as part of an immunosuppression regimen for the prevention of islet transplant rejection achieved insulin independence. An additional three islet transplant recipients have now been enrolled as well, bringing the total enrollment in the trial to six patients.
    • Preclinical data in liver allotransplantation utilizing tegoprubart was presented at WTC 2025 demonstrating markedly prolonged graft survival in non-human primates (NHPs) by targeting the CD40 Ligand pathway and the potential for transplant tolerance induction.
    • Announced a second investigator-initiated trial at the University of Chicago Medicine’s Transplant Institute evaluating tegoprubart as part of an immunosuppression regimen for the prevention of islet transplant rejection in patients with impaired kidney function.
    • Hosted an R&D Day in New York City that highlighted recent progress for the Company’s lead investigational candidate, tegoprubart, with a focus on its clinical development progress in organ and cell transplantation, including the ongoing Phase 2 BESTOW trial. The event featured members of Eledon’s executive team and leading experts in the field of transplantation. A replay of the R&D Day event can be found on Eledon’s website at https://ir.eledon.com/news-and-events/events
    • In June 2025, the Company was added to the Russell 3000® and Russell 2000® Indexes following the annual reconstitution, broadening visibility among investors as Eledon approaches key regulatory milestones.

    Anticipated Upcoming Milestones for 2H 2025

    • November 2025: Report topline results from the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
    • Launch an investigator-initiated trial at MGH evaluating tegoprubart as part of an immunosuppression regimen to induce donor-specific immune tolerance through mixed chimerism.
    • Enroll three additional patients in the investigator-led clinical trial at UChicago Medicine in subjects with type 1 diabetes treated with tegoprubart as part of an immunosuppression regimen for the prevention of pancreatic islet transplant rejection.

    Second Quarter 2025 Financial Results

    Cash, cash equivalents and short-term investments totaled $107.6 million as of June 30, 2025 compared to $140.2 million as of December 31, 2024. The company expects current cash, cash equivalents and short-term investments to fund operations to the end of 2026.

    Research and development (R&D) expenses for the second quarter of 2025 were $20.3 million, including $1.1 million of non-cash stock-based compensation expense, compared to $10.1 million, including $0.8 million of non-cash stock-based compensation expense, for the comparable period in 2024.

    General and administrative expenses for the second quarter of 2025 were $4.5 million, including $1.6 million of non-cash stock-based compensation expense, compared to $4.4 million, including $2.2 million of non-cash stock-based compensation expense, for the comparable period in 2024.

    Net loss for the second quarter of 2025 was $11.2 million, or $0.13 per basic common share, compared to a net loss of $44.9 million, or $0.92 per basic common share, for the comparable period in 2024.

    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, liver allograft 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; Twitter

    Forward Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, 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: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor Contact:

    Stephen Jasper
    Gilmartin Group
    (858) 525 2047
    stephen@gilmartinir.com

    Media Contact:

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

    Source: Eledon Pharmaceuticals

    Cocrystal Pharma (COCP) – 2Q25 Reported With Norovirus and Influenza Product Updates

    Posted on by slightbourne@noblecapitalmarkets.com


    Friday, August 15, 2025

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

    Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

    Refer to the full report for the price target, fundamental analysis, and rating.

    Antivirals Continue To Move Forward. Cocrystal reported 2Q25 loss of $2.1 million or $(0.20) per share. During 2Q, the company presented data from its CDI-988 Phase 1 study in norovirus. Separately, CDI-988 has demonstrated inhibition of multiple strains, including GII.17 and GII.4 that have caused norovirus outbreaks over the past 2 years. The Phase 2a human challenge study testing CC-42344 in influenza has been extended. CC-42344 has shown inhibition of several strains of avian influenza that have caused public health concerns. Cash on June 30, 2025 was $4.8 million.

    Phase 1b Is Planned For CDI-988  In Norovirus. Data from a Phase 1 trial showing safety and efficacy of CDI-988 was presented in August. The data show that CDI-988 was safe and effective through a range of doses in a single-ascending (SAD) and multiple-ascending (MAD) dose cohorts. A Phase 1b study testing CDI-988 as both treatment and prophylaxis for norovirus is planned for later in FY2025.


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    This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

    *Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

    Release – Unicycive Therapeutics Announces Second Quarter 2025 Financial Results and Provides Business Update

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on UNCY

    August 14, 2025 7:00am EDT Download as PDF

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    – Type A Meeting requested with U.S. Food and Drug Administration (FDA) for resolution of the Complete Response Letter (CRL) for oxylanthanum carbonate (OLC)

    – OLC pivotal study data, published in the Clinical Journal of the American Society of Nephrology (CJASN), demonstrated OLC was well tolerated and enabled serum phosphate control in over 90% of patients with a low pill burden

    – Ended Q2 with $22.3 million of cash with expected runway into the second half of 2026

    LOS ALTOS, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended June 30, 2025, and provided a business update.

    “Our team has made great progress in the second quarter, and we have requested a Type A meeting with the FDA to resolve the CRL and obtain regulatory approval. We believe we have built multiple approaches to correct the deficiency noted for our third-party manufacturing vendor, which was unrelated to OLC,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Meanwhile, the recently published pivotal trial data in CJASN continue to highlight OLC’s best-in-class potential. Given the high rates of patient non-compliance with existing phosphate lowering therapies, we remain fully committed to meeting this clear need for improved treatment options for managing hyperphosphatemia in dialysis patients.”

    Key Highlights & Upcoming Milestones

    • Unicycive has requested a Type A meeting with the FDA to discuss resolution of the CRL received in June in regard to its New Drug Application for OLC. Typically, Type A meetings are granted by the FDA within 30 days of the request. The Company plans to provide an investor update in the third quarter once it has received the FDA’s written feedback.
    • In July, the Company announced the publication of pivotal clinical study data describing the safety and tolerability of OLC in CKD patients on dialysis in CJASN. Data demonstrated that OLC was well tolerated, with over 90% of patients achieving effective phosphate control with most individuals needing no more than one tablet per meal.

    Financial Results for the Quarter Ended June 30, 2025

    Research and Development (R&D) expenses were $1.8 million for the three months ended June 30, 2025, compared to $4.9 million for the three months ended June 30, 2024. The decrease in research and development expenses was primarily due to decreased drug development costs.

    General and Administrative (G&A) expenses were $5.2 million for the three months ended June 30, 2025, compared to $2.5 million for the three months ended June 30, 2024. The increase was primarily due to increased consulting and professional services related to our commercial launch preparation.

    Other income was $0.5 million for the three months ended June 30, 2025, compared to other income of $17.3 million for the three months ended June 30, 2024, primarily due to the change in fair value of our warrant liability.

    Net loss attributable to common stockholders for the three months ended June 30, 2025, was $6.4 million, compared to net income attributable to common stockholders of $3.0 million for the three months ended June 30, 2024. The increased net loss for the three-month period ended June 30, 2025 was primarily due to the change in fair value of our warrant liability.

    As of June 30, 2025, cash and cash equivalents totaled $22.3 million. The Company believes that it has sufficient resources to fund operations into the second half of 2026.

    About Unicycive Therapeutics

    Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information about Unicycive, visit Unicycive.com and follow us on LinkedIn and X.

    Forward-looking statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; our need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to delays in obtaining or failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; and our failure, or the failure of our third-party manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, which could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Investor Contacts:

    Kevin Gardner
    LifeSci Advisors
    kgardner@lifesciadvisors.com

    Media Contact:

    Rachel Visi
    Real Chemistry
    redery@realchemistry.com

    SOURCE: Unicycive Therapeutics, Inc.

    View full release here.

    Release – MAIA Biotechnology Granted European Patent for Next Generation Telomere-Targeting Agents for Cancer Therapy

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on MAIA

    August 13, 2025 9:01am EDT Download as PDF

    Cancer-fighting immunosuppressive agents shown to disrupt telomeres and suspend growth of cancer cells 

    CHICAGO , Aug. 13, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that the European Patent Office has decided to grant a patent broadly covering a portfolio of ateganosine-based analogues for telomere-targeting anticancer therapy and methods of using ateganosine (THIO) alone or before administration of checkpoint inhibitors (CPIs). The patent, titled “Mercaptopurine Ribonucleoside Analogues for Altering Telomerase Mediated Telomere,” was invented by MAIA’s Chief Scientific Officer Sergei M. Gryaznov, PhD and Scientific Advisory Board member Jerry W. Shay, PhD.

    “Mercaptopurine nucleoside analogues are cancer-fighting immunosuppressive agents that disrupt the structure and function of telomeres and reduce immune system activity, interfering with the growth of cancer cells and causing programmed cancer cell death. As an important extension of MAIA’s innovative cancer treatment platform, these new compounds are key next-generation telomere-targeting agents with potentially improved specificity towards cancer cells relative to normal cells and with potentially increased anticancer activity,” said Dr. Gryaznov.

    “The new IP is expected to further secure and expand the value of our first-in-class telomere-targeting compounds across the European scientific community,” added MAIA Chairman and CEO Vlad Vitoc, M.D.

    MAIA’s global patent and patent-pending estate covers several areas including telomerase mediated telomere altering compounds and treatment of therapy-resistant cancers. Further, ateganosine’s immunogenic treatment strategy, which focuses on sequential combination with checkpoint inhibitors, has been filed worldwide. MAIA’s IP portfolio for ateganosine currently comprises 10 issued patents worldwide including Europe (validated in 19 countries) along with 24 pending patent applications.

    About Ateganosine

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

    About MAIA Biotechnology, Inc.

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

    Forward Looking Statements

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

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

    Primary Logo

    Source: MAIA Biotechnology, Inc.

    Released August 13, 2025

    Release – Ocugen, Inc. Announces Positive Scientific Advice from the European Medicines Agency Related to the Approval Pathway for OCU410ST—Modifier Gene Therapy for Stargardt Disease

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on OCGN

    August 13, 2025

    PDF Version

    MALVERN, Pa., Aug. 13, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed the study design, endpoints and planned statistical analysis of the ongoing pivotal confirmatory OCU410ST Phase 2/3 GARDian3 clinical trial for Stargardt disease and provided acceptability of a single U.S.-based trial for submission of a Marketing Authorization Application (MAA).

    EMA provided this opinion based on safety and tolerability that OCU410ST demonstrated in the Phase 1 GARDian trial, including 48% slower lesion growth and statistically significant (p=0.031) and clinically meaningful improvement of nearly 2-line/9-letter gain in best corrected visual acuity (BCVA) at 12-month follow-up in evaluable treated eyes compared to untreated eyes. The Phase 2/3 study will enroll 51 participants diagnosed with Stargardt disease. Of these, 34 will receive a one-time subretinal injection of OCU410ST (200 μL at a concentration of 1.5 × 10¹¹ vector genomes/mL) in the eye with poorer visual acuity, while 17 will be assigned to an untreated control group. The unique adaptive design of this trial includes a masked interim analysis of 24 subjects in the study (16 in treatment group and 8 in control group) at 8 months. The primary objective of the trial is to evaluate the reduction in atrophic lesion size. Key secondary endpoints include improvements in BCVA and low luminance visual acuity (LLVA), compared to controls. Data from the one-year follow-up will be used to support the Company’s planned Biologics License Application (BLA) and MAA in the EU.

    “This positive opinion endorses a single trial as the basis for both BLA and MAA submissions and brings us closer to providing a one-time, modifier gene therapy to approximately 100,000 Stargardt patients in the U.S. and Europe combined,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “We are very encouraged about the prospect of addressing the unmet medical need that exists for these patients who currently have no approved treatment options available to them.”

    The EMA opinion is an extremely favorable outcome, as it will potentially reduce the time and cost to gain marketing authorization in the EU. Alignment with the EMA follows recent important milestones for the OCU410ST program, including Rare Pediatric Disease Designation (RPDD) in May, IND clearance in June, and first patient dosing in July. With enrollment scheduled to be complete in the first quarter of 2026 the Company remains on track for a BLA filing in the first half of 2027, aligned with its goal of three BLAs in the next three years.

    About OCU410ST
    OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR-Related Orphan Receptor A) gene. It represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathophysiological pathways linked to Stargardt disease, such as lipofuscin formation, oxidative stress, complement formation, inflammation, and cell survival networks.

    About Stargardt Disease
    Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.

    Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.

    About Ocugen, Inc.
    Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at www.ocugen.com and follow us on X and LinkedIn.

    Cautionary Note on Forward-Looking Statements
    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

    Contact:
    Tiffany Hamilton
    AVP, Head of Communications
    Tiffany.Hamilton@ocugen.com

    Release – Ocugen, Inc. Announces Closing of $20 Million Registered Direct Offering of Common Stock and Warrants

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on OCGN

    August 12, 2025

    PDF Version

    MALVERN, Pa., Aug. 12, 2025 (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 its previously announced registered direct offering pursuant to a securities purchase agreement with Janus Henderson Investors, a global asset management firm, for the purchase and sale of 20,000,000 shares of common stock and warrants to purchase up to an aggregate of 20,000,000 shares of common stock at a purchase price of $1.00 per share (closing price on August 7, 2025) and accompanying warrant. The warrants have an exercise price of $1.50 per share, are exercisable immediately upon issuance, and will expire two years following the date of issuance. The warrants are callable by the Company when the VWAP of the Company’s common stock exceeds $2.50 per share for at least five of a trailing 30 trading day period. 

    Noble Capital Markets, Inc. acted as the sole placement agent in connection with the offering. Maxim Group LLC and Titan Partners Group, a division of American Capital Partners, acted as independent financial advisors in connection with the offering.

    The gross proceeds to the Company were approximately $20 million before deducting the placement agent fees and other estimated offering expenses, which the Company anticipates will extend the Company’s cash runway into the second quarter of 2026. The Company may receive up to $30 million of additional gross proceeds if the warrants are exercised in full. The Company anticipates that combined offering proceeds of $50 million with warrant exercise will extend the Company’s cash runway into the first quarter of 2027. The offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-278774) previously filed with the U.S. Securities and Exchange Commission (“SEC”), which was declared effective on May 1, 2024. The offering was made only by means of a prospectus forming a part of the effective registration statement relating to the offering. A prospectus supplement relating to the shares of common stock and warrants has been filed by the Company with the SEC. Copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Noble Capital Markets, Inc., 150 East Palmetto Park Rd., Suite 110, Boca Raton, FL 33432.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Ocugen, Inc.

    Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X and LinkedIn.

    Cautionary Statement Regarding Forward–Looking Statements

    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. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including the Company’s expected cash runway, whether the warrants will be exercised and various other factors. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

    Ocugen Contact:

    Tiffany Hamilton
    AVP, Head of Communications
    Tiffany.Hamilton@Ocugen.com

    Release – Ocugen, Inc. Announces $20 Million Registered Direct Offering of Common Stock and Warrants

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on OCGN

    August 8, 2025

    PDF Version

    MALVERN, Pa., Aug. 08, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it has entered into a securities purchase agreement with Janus Henderson Investors, a global asset management firm, to purchase 20,000,000 shares of common stock and warrants to purchase up to an aggregate of 20,000,000 shares of common stock at a purchase price of $1.00 per share (closing price on August 7, 2025) and accompanying warrant in a registered direct offering. The warrants have an exercise price of $1.50 per share, are exercisable immediately upon issuance, and will expire two years following the date of issuance. The warrants are callable by the Company when the VWAP of the Company’s common stock exceeds $2.50 per share for at least five of a trailing 30 trading day period. 

    Noble Capital Markets, Inc. acting as the sole placement agent in connection with the offering.

    The gross proceeds to the Company are expected to be approximately $20 million before deducting the placement agent fees and other estimated offering expenses. The Company may receive up to $30 million of additional gross proceeds if the warrants are exercised in full. The offering is expected to close on or about August 11, 2025, subject to the satisfaction of customary closing conditions. The offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-278774) previously filed with the U.S. Securities and Exchange Commission (“SEC”), which was declared effective on May 1, 2024. The offering is made only by means of a prospectus forming a part of the effective registration statement relating to the offering. A prospectus supplement relating to the shares of common stock and warrants will be filed by the Company with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Noble Capital Markets, Inc., 150 East Palmetto Park Rd., Suite 110 Boca Raton, FL 33432.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Ocugen, Inc.

    Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X and LinkedIn.

    Cautionary Statement Regarding Forward Looking Statements

    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. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including the satisfaction of customary closing conditions related to the offering, completion of the offering, whether the warrants will be exercised and various other factors. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

    Ocugen Contact:

    Tiffany Hamilton
    AVP, Head of Communications
    Tiffany.Hamilton@Ocugen.com

    Release – GeoVax Comments on HHS mRNA Vaccine Rollback: Urges Full Embrace of MVA-Based Multi-Antigen Vaccine

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on GOVX

    GEO-CM04S1 Offers Solution to Overcome HHS-Cited mRNA Deficiencies – Potentially Offering Broader, More Durable Protection

    ATLANTA, GA – August 7, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen, MVA-based vaccines and solid tumor immunotherapies, today issued a statement in response to the U.S. Department of Health and Human Services’ (HHS) decision to terminate nearly $500 million in BARDA-funded mRNA vaccine development contracts.

    This action reflects a policy shift, underscored by HHS Secretary Kennedy addressing fundamental concerns around mRNA vaccines. In a post on X, Secretary Kennedy stated: “mRNA vaccines don’t perform well against viruses that infect the upper respiratory tract”. The Secretary added that this is due to a concept known as “antigenic shift, meaning that the vaccine paradoxically encourages new mutations and can actually prolong pandemics as the virus constantly mutates”. GeoVax’s vaccine candidates, including GEO-CM04S1 for COVID-19, are designed to induce immunity using multiple antigens. GEO-CM04S1 expresses both the Spike (S) and Nucleocapsid (N) proteins of SARS-CoV-2, enabling broader and more durable protection – even as the virus mutates. Data from clinical studies have demonstrated that GEO-CM04S1 induces immune responses across variants, from the original Wuhan strain through Omicron, even in immunocompromised patients.

    “Secretary Kennedy’s remarks spotlight the exact issue our platform was designed to overcome,” said David Dodd, Chairman and CEO of GeoVax. “The mRNA approach, with its single-target design, appears limited relative to durability and antigenic shift. GEO-CM04S1’s multi-antigen construct represents a promising solution – with clinical data demonstrating broader immunity and addressing the mRNA shortcomings Kennedy described, including among the most vulnerable immunocompromised patients.”

    Why GeoVax’s MVA-Based Vaccines Align with U.S. Priorities

    • Multi‑antigen breadth and durability – GeoVax’s COVID-19 vaccine candidate, GEO‑CM04S1, expresses both SARS‑CoV‑2 Spike and Nucleocapsid proteins – inducing robust and durable antibody and T‑cell immunity in Phase 2 trials. Notably, in a trial among Chronic Lymphocytic Leukemia (CLL) patients, the mRNA comparator arm was halted for failing to meet immune‑response benchmarks, while GEO‑CM04S1 exceeded interim endpoints, with the remainder of the ongoing study only including the GEO-CM04S1 arm. 
    • Safety for vulnerable populations – MVA does not replicate in human cells and has been FDA‑approved for use in immunocompromised individuals, pregnant women, and children. This makes it a validated vaccine platform with broad safety.
    • Manufacturing innovation and U.S. resilience – GeoVax is advancing AGE.1 manufacturing processes for MVA-based vaccines such as GEO-CM04S1 which is expected to support scalable, decentralized U.S. vaccine manufacturing, providing faster production, higher yield at a reduced cost – a strategic advantage for public health resilience.
    • Broad infectious-disease pipeline – Beyond COVID‑19, GeoVax is pursuing MVA‑based vaccines targeting hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, Marburg), Zika, and Mpox/Smallpox. This diversified pipeline aligns with HHS, NIH, FDA, and WHO priorities for pandemic preparedness and biodefense.

    GeoVax: Delivering on the “Safer, Broader” Vision

    GeoVax applauds the call to shift toward multi-antigen vaccine designs with validated safety profiles and resilience to viral mutation. The MVA‑based platform delivers on these goals:

    • Evidence‑backed safety for immunocompromised, pediatric, and pregnant populations.
    • Broader immune responses with Spike plus Nucleocapsid antigens.
    • Strategic manufacturing design for domestic scale and surge capacity.
    • Multi‑disease readiness across COVID‑19, hemorrhagic fevers, Zika, and Mpox/Smallpox.

    Next Steps: Turning Rhetoric into Resilience

    GeoVax urges HHS to proactively support robust, evidence-backed alternatives – including multi-antigen platforms like MVA as part of a diversified, resilient biomedical countermeasure arsenal.

    GeoVax invites HHS and other federal partners to collaborate under the FDA’s Commissioner’s National Priority Voucher (CNPV) program and other mechanisms to accelerate regulatory and funding support for GEO-CM04S1 and GEO-MVA, both of which are uniquely positioned to protect high-risk populations and enhance U.S. biomanufacturing self-sufficiency.

    Dodd added: “We must now invest in platforms that reflect what we’ve learned. GeoVax stands ready to lead this transition. Our MVA platform already has a safety track record and is delivering early efficacy where mRNA appears to have fallen short. We stand ready and prepared to assist in supporting HHS’s bold reset into a long-term strategy for national immunization security.”

    About GeoVax

    GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

    Forward-Looking Statements

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

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

    Company Contact:

    info@geovax.com

    678-384-7220

    Media Contact:

    Jessica Starman

    media@geovax.com 

    Release – Eledon Presents Updated Data from Ongoing Phase 1b Trial Evaluating Tegoprubart for Prevention of Rejection in Kidney Transplantation

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on ELDN

    August 6, 2025

    PDF Version

    Data from patients who remained on tegoprubart for a year showed overall mean 12-month eGFR of approximately 68 mL/min/1.73 m² post-transplant

    Preliminary iBox data, a key biomarker of kidney function and immunologic response, supports that tegoprubart may improve 5-year graft survival vs. current standard of care

    Tegoprubart continues to be well tolerated with no cases of death, graft loss, drug related tremor, or new-onset diabetes

    Conference call to be held today at 4:30 p.m. ET

    IRVINE, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced updated data from the Company’s ongoing open-label Phase 1b trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Results from the oral presentation, titled “Tegoprubart, an Anti-CD40L Antibody, for the Prevention of Rejection in Kidney Transplantation: An Ongoing Phase 1b Study,” were presented today at the World Transplant Congress (WTC) taking place in San Francisco, CA.

    “The data presented today at WTC further reinforce our belief that tegoprubart has the potential to not only provide better protection and long-term preservation of kidney function following transplantation, but also to offer a safer alternative to traditional immunosuppressive therapies by minimizing harmful side effects,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The continued strength of the Phase 1b data through 12 months of treatment is highly encouraging as we look ahead to topline results from our Phase 2 BESTOW trial, expected in November, which compares tegoprubart to tacrolimus, the current standard of care.”

    As of the July 2025 cutoff date, 32 patients undergoing kidney transplantation have been enrolled in the Phase 1b study. Updated data showed that kidney function, as assessed by estimated glomerular filtration rate (eGFR), stabilized after the first month post-transplant and remained in the range of approximately 68 mL/min/1.73 m2 through 12 months for patients (n=12) who remained on tegoprubart​. Kidney function in the intention-to-treat population (n=15) was approximately 63 mL/min/1.73 m2 at 12 months. Data from historical studies using the standard of care, calcineurin inhibitor-based immunosuppression therapy, typically report aggregate mean estimated glomerular filtration rates (eGFRs) of approximately 53 mL/min/1.73 m2 during the first year after kidney transplant.

    In addition, preliminary abbreviated iBox data was presented suggesting that tegoprubart may improve 5-year graft survival. Abbreviated iBox, a composite biomarker panel developed by the Paris Transplant Group, incorporates kidney function (eGFR, proteinuria) and immunologic response (donor-specific antibodies) parameters into a single prognostic score. Based on data collected to date, abbreviated iBox scores were ​-3.75 in the intention-to-treat population and -4.11 in the on-treatment population, which compare favorably to a -2.98 historical mean for calcineurin inhibitors. A difference in abbreviated iBox score of -0.40 at 12 months is considered predictive of a 4-5% difference in 5-year graft survival suggesting that tegoprubart may have a predicted 5-year allograft survival rate of over 96%.

    Mean tegoprubart treatment exposure to date was 233 days. Tegoprubart continues to be well-tolerated with no cases of death, graft loss, drug related tremor, or new-onset diabetes, a side effect associated with standard of care immunosuppression therapy.

    There were six (18.8%) rejection episodes, and 75% of patients who experienced a rejection had received low-dose rabbit antithymocyte globulin (rATG) induction. All rejection episodes were successfully treated. Of the patients who experienced a rejection episode and completed a year in the study, three who remained on tegoprubart had a mean eGFR of approximately 73 mL/min/1.73 m2 at 12 months, indicating full recovery of kidney function, while the two patients who switched to standard of care tacrolimus had a mean eGFR of approximately 34 mL/min/1.73 m² at 12 months.

    All 32 patients received rATG induction therapy and a maintenance regimen consisting of tegoprubart, mycophenolate mofetil, and corticosteroids.

    • Cohort 1 has completed enrollment and evaluated tegoprubart at a dose of 20 mg/kg with rATG induction up to 6 mg/kg.
    • Cohort 2 is currently enrolling and is evaluating a lower tegoprubart dose of 10 mg/kg, with a required rATG dose of 4.5 mg/kg.
    • The primary endpoint of the study is safety and pharmacokinetics. Secondary and exploratory endpoints include patient and graft survival, biopsy-proven acute rejection, kidney function as measured by estimated by eGFR, and abbreviated iBox score.

    Eledon is also conducting a Phase 2 trial (BESTOW; NCT05983770) and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. Topline results from the Phase 2 BESTOW trial are anticipated in November 2025.

    Full details of the WTC oral presentation are below:

    Title: Tegoprubart, an Anti-CD40L Antibody, for the Prevention of Rejection in Kidney Transplantation: An Ongoing Phase 1b Study
    Session: Oral Presentation, Kidney Novel Immunosuppressant Strategies
    Presenter: John Gill, MD, MS, University of British Columbia, Vancouver, Canada
    Session Date and Time: Wednesday, August 6, 2025: 10:00 a.m. – 11:15 a.m. PT

    Conference Call

    Eledon will hold a conference call today, August 6, 2025 at 4:30 p.m. Eastern Time to discuss the updated Phase 1b trial results. To join the conference call, please dial 1-800-717-1738 for domestic callers or 1-646-307-1865 for international callers. The conference ID is 34575. Registration for the live webcast can be found here and available on the “Events” section of Eledon’s website at www.eledon.com. The webcast will be archived on the website following the completion of the call.

    About Eledon Pharmaceuticals and tegoprubart

    Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

    Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

    About iBox

    iBox is a composite biomarker panel developed by the Paris Transplant Group to predict long-term kidney graft survival. It combines kidney function (eGFR, proteinuria), immunologic response (donor-specific antibodies), and histopathology (Banff scores) into a single prognostic score. Validated across four independent cohorts, including two Phase 3 trials (BMS BENEFIT and BENEFIT-EXT), iBox has demonstrated strong predictive accuracy (C-statistic >0.8) for 5-year graft loss and outperforms traditional markers like biopsy-proven acute rejection. Both full and abbreviated iBox models have been qualified by the European Medicines Agency (EMA) and accepted by the U.S. FDA into the Biomarker Qualification Program. The iBox Composite Biomarker Panel is under review by the FDA as a Reasonably Likely Surrogate Endpoint (RLSE) for use as a co-primary endpoint in Phase 2/3 trials, supporting potential accelerated approval of novel immunosuppressive therapies. This makes iBox the first transplant-specific endpoint formally recognized under FDA’s biomarker qualification framework.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about ongoing clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with kidney transplantation, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

    Investor Contact:

    Stephen Jasper
    Gilmartin Group
    (858) 525 2047
    stephen@gilmartinir.com

    Media Contact:

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

    Source: Eledon Pharmaceuticals

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    Source: Eledon Pharmaceuticals, Inc.

    Alcon to Acquire STAAR Surgical in $1.5 Billion Deal to Expand Vision Correction Portfolio

    Posted on by slightbourne@noblecapitalmarkets.com

    Alcon (NYSE: ALC), a global leader in eye care, has signed a definitive agreement to acquire STAAR Surgical Company (NASDAQ: STAA) in a cash transaction valued at approximately $1.5 billion. The acquisition is aimed at bolstering Alcon’s position in the surgical vision correction market, particularly in addressing the growing global demand for alternatives to LASIK.

    The deal will see Alcon purchasing all outstanding shares of STAAR common stock at $28 per share, representing a 59% premium to STAAR’s 90-day volume-weighted average price and a 51% premium over its August 4 closing price.

    STAAR Surgical is best known for its EVO family of Implantable Collamer Lenses (ICLs), which offer minimally invasive, reversible vision correction for patients with moderate to high myopia, including those with astigmatism. These lenses are implanted behind the iris and in front of the eye’s natural lens, offering a surgical option that avoids corneal tissue removal.

    For Alcon, the acquisition is a strategic complement to its existing laser vision correction business. By incorporating STAAR’s EVO ICL technology, the company aims to provide a broader spectrum of refractive solutions for patients, especially those who are not ideal candidates for LASIK or other laser procedures.

    The need for such alternatives is expanding rapidly. Global studies suggest that by 2050, half of the world’s population will be myopic, with approximately 500 million people falling into the high myopia category—a group that often requires advanced vision correction techniques.

    Alcon expects the acquisition to be accretive to earnings by the second year post-closing. The company plans to finance the purchase through short- and long-term credit facilities and noted that the transaction is not subject to a financing condition.

    STAAR has faced recent market challenges, including fluctuating demand in key international markets such as China. By joining Alcon, STAAR is expected to benefit from increased operational scale and broader global distribution, which could accelerate the adoption of its EVO ICLs.

    The transaction has received unanimous approval from both companies’ boards of directors. It is expected to close within six to twelve months, pending customary closing conditions, including regulatory clearances and approval by STAAR shareholders.

    Financial advisors on the deal include Morgan Stanley for Alcon and Citi for STAAR, while legal counsel was provided by Gibson, Dunn & Crutcher LLP and Wachtell, Lipton, Rosen & Katz, respectively.

    As part of ongoing developments, STAAR is scheduled to release its Q2 2025 earnings on August 6, though it will not hold an investor conference call due to the pending acquisition.