Tag: Biotechnology

MAIA Biotechnology (MAIA) – Roche Forms Supply Agreement For THIO Combination Studies

Posted on by slightbourne@noblecapitalmarkets.com


Friday, June 20, 2025

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 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.

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.

MAIA Makes Its Third Supply Agreement. MAIA announced that it has entered a supply agreement with Genentech/Roche to test THIO (ateganosine) in combination with Tecentriq (atezolizumab, Roche’s PD-L1 checkpoint inhibitor) for the treatment of several hard-to-treat cancers. MAIA now has supply agreements to test THIO in combination with checkpoint inhibitors from three global pharmaceutical companies, which we see as an indicator of interest for future partnerships.

PD-1 or PD-1L? That Is The Question. Checkpoint inhibitors block the interaction of the surface proteins PD-1 (programmed death receptor-1) with PD-1L (the programed death receptor-1 ligand). When the PD-1 receptor binds to the PD-1L ligand, it inhibits the immune response. Checkpoint inhibitors are monoclonal antibody drugs against PD-1 or PD-L1 that block this interaction, allowing cancer cells to be recognized by a patient’s immune system and killed.


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Release – MAIA Biotechnology Announces Master Clinical Supply Agreement with Roche for Hard-to-Treat Cancer Therapies

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

June 18, 2025 9:15am EDT Download as PDF

  • Agreement to support future studies investigating the combination of ateganosine and atezolizumab for safe and effective cancer treatments

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced its entry into a clinical master supply agreement with Roche for future studies investigating the combination of MAIA’s telomere-targeting agent ateganosine (THIO), sequenced with Roche’s checkpoint inhibitor (CPI), atezolizumab (Tecentriq®), for the treatment of multiple hard-to-treat cancers.

“In preclinical studies, ateganosine was found to be highly synergistic and effective in combination with Roche’s anti-PD-L1 agent atezolizumab,” said MAIA Chairman and CEO Vlad Vitoc, M.D. “We are pleased to partner with world-renowned Roche and we look forward to further strengthening our mission to find safe and effective cancer treatments.”

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 activate both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with 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.

Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

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

Source: MAIA Biotechnology, Inc.

Released June 18, 2025

Release – Unicycive Therapeutics, Inc. Announces Reverse Stock Split

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

June 17, 2025 7:00am EDT Download as PDF

Shares Expected to Begin Trading on Split-Adjusted Basis on June 20, 2025

LOS ALTOS, Calif., June 17, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (NASDAQ: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it will implement a 1-for-10 reverse split of the issued shares of its common stock, effective at 4:01 p.m. Eastern Time on June 18, 2025. The Company’s common stock is expected to begin trading on a split-adjusted basis when the market opens on June 20, 2025, and will continue to trade on The Nasdaq Capital Market under the symbol “UNCY.” The new CUSIP number for the common stock will be 90466Y 202.

The reverse stock split is intended to increase the bid price of the common stock to enable the Company to regain compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market. The Company’s stockholders authorized the reverse stock split at the Company’s annual meeting of stockholders held on June 9, 2025 and granted the board the authority to determine a final reverse split ratio.

When the reverse stock split becomes effective, every ten (10) shares of the Company’s common stock issued and outstanding or held by the Company in treasury will automatically be combined and reclassified into one (1) share of common stock. No fractional shares will be issued as a result of the reverse stock split. Stockholders who would otherwise be entitled to receive a fractional share will instead automatically have their fractional interests rounded up to the next whole share, after aggregating all the fractional interests of a holder resulting from the reverse stock split. The reverse stock split will affect all stockholders uniformly and will not change any stockholder’s percentage ownership interest or any stockholder’s proportionate voting power, except for immaterial changes that may result from the treatment of fractional shares. The reverse stock split will not change the number of authorized shares of the Company’s common stock or the par value per share of the Company’s common stock.

The reverse stock split will reduce the number of issued and outstanding shares of the Company’s common stock from approximately 126,409,281 to approximately 12,640,929.

As a result of the reverse stock split, proportionate adjustments will be made to the per share exercise prices of, and the number of shares underlying, the Company’s outstanding stock options, as well as to the number of shares available for future awards granted under the Company’s stock incentive plans. In addition, proportionate adjustments will be made to the per share exercise prices of, and the number of shares underlying, outstanding warrants to purchase shares of the Company’s common stock. Further, proportionate adjustments will also be made to the per share conversion price of the Company’s series A and series B preferred stock, pursuant to their respective terms.

The combination of, and reduction in, the issued shares of common stock as a result of the reverse stock split will occur automatically at the effective time of the reverse stock split without any additional action on the part of the Company’s stockholders. The Company’s transfer agent, Pacific Stock Transfer Company, is acting as the exchange agent for the reverse stock split and will send stockholders of record holding their shares electronically in book-entry form a transaction notice indicating the number of shares of common stock held after the reverse stock split. Stockholders who hold their shares through a broker, bank, or other nominee will have their positions adjusted to reflect the reverse stock split, subject to their broker, bank, or other nominee’s particular processes, and are not expected to be required to take any action in connection with the reverse stock split.

Additional information regarding the reverse stock split can be found in the Company’s definitive proxy statement for the annual meeting of stockholders of the Company held on June 9, 2025, which was filed with the U.S. Securities and Exchange Commission on April 30, 2025, a copy of which is available at www.sec.gov and on the Company’s website.

About Unicycive Therapeutics

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

Forward-Looking Statements

The Company cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to the timing, completion and effect of the reverse stock split and the Company’s ability to regain compliance with Nasdaq’s minimum bid price requirement and continue to have its common stock listed on The Nasdaq Capital Market. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, the risk that Nasdaq may not process the reverse stock split on the expected timeline; the risk that after the reverse stock split the closing bid price of the Company’s common stock is not at least $1.00 per share for a minimum of ten consecutive trading sessions; the potential for Nasdaq to suspend trading in or to delist the Company’s common stock. Forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of risks and uncertainties the Company faces, you are encouraged to review the documents the Company files with the SEC including the Company’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Investor Contacts:

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Media Contact:

Rachel Visi
Real Chemistry
redery@realchemistry.com

Primary Logo

Source: Unicycive Therapeutics, Inc.

Released June 17, 2025

Release – Ocugen, Inc. Announces U.S. FDA Clearance of Investigational New Drug Amendment to Initiate Phase 2/3 Pivotal Confirmatory Clinical Trial of OCU410ST—Modifier Gene Therapy Candidate for Stargardt Disease

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

June 16, 2025

PDF Version

MALVERN, Pa., June 16, 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 U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) amendment to initiate a Phase 2/3 pivotal confirmatory trial of OCU410ST, a modifier gene therapy candidate being developed for all Stargardt disease (ABCA4-associated retinopathies). The FDA previously granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19, and cone-rod dystrophy 3.

“We have had a highly productive and collaborative engagement with the FDA’s Center for Biologics Evaluation and Research (CBER) in establishing the pivotal confirmatory trial for OCU410ST,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen. “It’s evident that there is a real sense of urgency by the agency in providing treatment options for patients who currently have nothing available to them. As we initiate the Phase 2/3 registration trial, we are expediting the clinical development of OCU410ST by two to three years and potentially providing an innovative gene therapy to patients desperate for a treatment option.”

Positive data from the Phase 1 GARDian trial for OCU410ST demonstrated:

  • A favorable safety and tolerability profile with no serious adverse events related to OCU410ST, including no cases of ischemic optic neuropathy, vasculitis, intraocular inflammation, endophthalmitis or choroidal neovascularization and no adverse events of special interest
  • Considerably slower lesion growth—48% at 12-month follow up in evaluable treated eyes when compared to untreated eyes
  • Statistically significant (p=0.031) improvement with clinically meaningful, nearly 2-line gain in visual function (BCVA) at 12-month follow-up in evaluable treated eyes when compared to untreated eyes

The Phase 2/3 clinical trial for OCU410ST 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 primary objective of the trial is to evaluate the reduction in atrophic lesion size. Key secondary endpoints include improvements in best corrected visual acuity (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 Biologics License Application (BLA).

“The initiation of this pivotal Phase 2/3 study represents a significant milestone in our commitment to bringing transformative genetic therapies to individuals affected by Stargardt disease—a progressive and debilitating condition,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “The recent RPDD granted by the FDA for this program further underscores the urgent need for innovative treatment options for children living with Stargardt disease. OCU410ST, developed through our proprietary modifier gene therapy platform, is designed to target the underlying biological mechanisms of the disease.”

Approximately 100,000 patients in U.S. and Europe combined and 1 million patients globally live with Stargardt disease. Stargardt and ABCA4-associated retinopathies are genetically complex, involving more than 1,200 known mutations and addressing this condition with traditional gene therapy or gene editing approaches remains highly challenging.

“Stargardt disease represents a significant unmet medical need, particularly among children and young adults,” said Lejla Vajzovic, MD, FASRS, Director of the Duke Surgical Vitreoretinal Fellowship Program and Professor of Ophthalmology, Pediatrics, and Biomedical Engineering with Tenure at Duke University Eye Center. “The Phase 2/3 study of OCU410ST is thoughtfully designed with scientific rigor and a patient-centered focus to evaluate both structural and functional outcomes. We are optimistic that this approach will move us closer to a meaningful therapeutic solution for affected families.”

The OCU410ST Phase 2/3 pivotal confirmatory trial represents a major advancement as Ocugen’s second late-stage clinical program. Ocugen plans to submit a BLA for OCU410ST in 2027 in alignment with its strategic goal of filing three BLAs over 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

Supernus Pharmaceuticals Acquires Sage Therapeutics in $795M Deal, Boosting Neuropsychiatric Pipeline

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Supernus to acquire Sage for up to $12.00 per share, combining upfront cash and milestone-based CVRs.
– Deal adds FDA-approved ZURZUVAE® for postpartum depression to Supernus’ growing CNS portfolio.
– Transaction expected to be accretive by 2026, with $200M in annual cost synergies forecast.

Supernus Pharmaceuticals (NASDAQ: SUPN) has announced a strategic acquisition of Sage Therapeutics (NASDAQ: SAGE) in a deal worth up to $795 million, signaling a bold expansion into the neuropsychiatric space. This all-cash transaction, set to close in Q3 2025, brings to Supernus a key commercial asset—ZURZUVAE® (zuranolone)—as well as access to Sage’s central nervous system (CNS) discovery platform.

The proposed deal includes an upfront payment of $8.50 per share in cash, representing approximately $561 million, and a non-tradable contingent value right (CVR) worth up to an additional $3.50 per share. The CVR milestones are tied to commercial performance of ZURZUVAE in the U.S. and its future launch in Japan.

This acquisition is a transformative step for Supernus, best known for CNS products such as Qelbree®, GOCOVRI®, and ONAPGO™. With the addition of ZURZUVAE—the first and only FDA-approved oral treatment for postpartum depression—the company further solidifies its footprint in the growing neuropsychiatry market. Supernus CEO Jack Khattar stated that the move “adds a fourth growth product” and “diversifies our sources of future growth.”

ZURZUVAE was developed by Sage and commercialized in partnership with Biogen. Under the collaboration, Supernus will recognize revenue equal to 50% of U.S. net sales. In 2024, that share amounted to $36.1 million, with $13.8 million already reported in Q1 2025—indicating an accelerating ramp that Supernus is now positioned to capitalize on.

From a financial perspective, the deal is expected to be significantly accretive starting in 2026, supported by estimated annual cost synergies of up to $200 million. Supernus will fund the transaction entirely through its existing cash reserves, avoiding equity dilution or new debt issuance. For investors, this adds a layer of financial discipline and long-term earnings potential.

Sage’s leadership, including CEO Barry Greene, called the deal the result of a comprehensive strategic review aimed at maximizing shareholder value. Greene highlighted the company’s mission in brain health and praised the Sage team’s work in delivering two first-in-class therapies for postpartum depression.

In terms of integration, Sage’s R&D pipeline and commercial operations will fold into Supernus’ existing infrastructure—a move expected to streamline costs and accelerate product development. The combined entity will also benefit from a strengthened CNS platform and expanded market reach.

While the deal is subject to customary closing conditions, including regulatory approvals and a majority tender of Sage’s outstanding shares, both companies anticipate a smooth closing process. Supernus plans to provide revised financial guidance following deal completion in Q3.

This acquisition reflects a strategic shift in mid-cap biopharma, where clinical differentiation and near-term revenue growth are prioritized. For small- and micro-cap investors, it also signals continued consolidation in the CNS space—where innovation, reimbursement potential, and strong commercialization strategy drive M&A activity.

Release – Cadrenal Therapeutics Highlights New Research on Anticoagulation Burden for LVAD Patients

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

  • LVAD patients face a high risk of bleeding events associated with oral anticoagulation alongside increased risk of cardiovascular (CV) events such as stroke
  • Hospitalization costs for patients following a major bleeding event associated with oral anticoagulation use averages $39,000 per event
  • Tecarfarin, with its novel metabolic pathway, potentially may offer an alternative to warfarin in this vulnerable population

PONTE VEDRA, Fla. – Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing novel therapeutics for patients with cardiovascular disease, today announced new findings from third-party research on the economic and medical burdens faced by advanced heart failure patients with left ventricular assist devices (LVAD) requiring chronic anticoagulation.

The research recently conducted by Guidehouse, an AI-led professional services firm delivering advisory, technology, and managed services to the commercial and government sectors, underscores the significant clinical and economic burden for LVAD patients who require chronic oral anticoagulation. Key findings include:

  • Major bleeds remain a primary cost driver, with average hospitalization costs (per event) of $54,100 for intracranial hemorrhage, $26,900 for gastrointestinal bleeds, and $36,600 for other major bleeds.

Guidehouse’s analysis also identified tecarfarin – a novel, Phase 3-ready oral anticoagulant being developed by Cadrenal – as a potential alternative to warfarin to address the current unmet need in this patient population. Tecarfarin is designed to provide more consistent anticoagulation control by avoiding the multiple metabolic pathways associated with warfarin. Its unique metabolism via a single enzyme (CES2) may reduce the risk of drug interactions, dietary complications, and adverse bleeding or thrombotic events.

“Despite decades of use, warfarin has significant limitations – especially in complex patients with LVADs,” said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. “This research reinforces our conviction that tecarfarin has the potential to transform anticoagulation management for this high-risk population who currently has no alternative options.”

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing therapeutics for patients with cardiovascular disease. Cadrenal’s lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that addresses unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for a number of indications, extensive clinical and real-world data have shown it can have significant, serious side effects. With tecarfarin, Cadrenal is advancing an innovative solution to address the unmet needs in anticoagulation therapy, aiming to reduce the clinical complexities of warfarin and capture value in a market with high demand for safer, more manageable treatment options.

Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted mechanical circulatory support devices, including Left Ventricular Assisted Devices (LVADs). The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib).

Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit https://www.cadrenal.com/and connect with us on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding Tecarfarin offering an alternative to warfarin for LVAD patients requiring chronic anticoagulation; providing more consistent anticoagulation control by avoiding the multiple metabolic pathways associated with warfarin; Tecarfarin’s metabolism via a single enzyme (CES2) reducing the risk of drug interactions, dietary complications, and adverse bleeding or thrombotic events; transforming anticoagulation management for LVAD patients who currently have no alternative options; preventing heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation; addressing the unmet needs in anticoagulation therapy; reducing the clinical complexities of warfarin; and capturing value in a market with high demand for safer, more manageable treatment options. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to provide clinical benefits for LVAD patients who require anticoagulation; the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Corporate and Investor Relations

Paul Sagan

LaVoieHealthScience

(617) 865-0041

psagan@lavoiehealthscience.com

Media

Andrew Korda

LaVoieHealthScience

(617) 865-0043

akorda@lavoiehealthscience.com

Unicycive Therapeutics (UNCY) – FDA Finds Deficiencies At Third-Party Manufacturing Subcontractor – Approval Could Be Delayed

Posted on by slightbourne@noblecapitalmarkets.com


Wednesday, June 11, 2025

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.

Approval May Come After The PDUFA Date Of June 28. Unicycive announced that an FDA inspection has found deficiencies with the cGMP (certified Good Manufacturing Practice) compliance at a third-party manufacturing subcontractor. The company’s product, OLC, is manufactured by a contract manufacturer with other subcontractors. The deficiency does not involve the active pharmaceutical compound (APC) and may be related to final finishing and packaging operations.

Good News and Bad News. The FDA stated that the manufacturing deficiencies must be resolved before product label discussions can proceed. We interpret this to mean that the FDA review of the clinical data has been completed, the manufacturing inspection was conducted, and product labeling remains as the final step before approval. Although the manufacturing deficiencies have stopped the labeling discussion, we expect NDA approval when corrected.


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Release – GeoVax Announces Upcoming Presentation at the European Hematology Association 2025 Congress Highlighting Positive Immune Response Data for GEO-CM04S1 in CLL Patients

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

ATLANTA, GA, June 10, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies against infectious diseases and solid tumors, today announced that clinical data for its next-generation COVID-19 multi-antigen vaccine candidate, GEO-CM04S1, will be presented at the European Hematology Association (EHA) 2025 Hybrid Congress, taking place June 12–15, 2025, in Milan, Italy and online.

Alexey V. Danilov, M.D., Ph.D., Associate Director of the Toni Stephenson Lymphoma Center and Professor in the Department of Hematology and Hematopoietic Cell Transplantation at the City of Hope Comprehensive Cancer Center in Duarte, California, will present a poster titled: “MVA-Based GEO-CM04S1 Vaccine Results in Improved Cellular Immune Response in Patients with Chronic Lymphocytic Leukemia (CLL) Compared with mRNA-Based Vaccine: Initial Results of a Phase II Randomized Study”. The poster will be featured on Saturday, June 14, 2025, from 18:30 to 18:30 CEST in the Poster Hall, as part of the session on Infections in Hematology (including supportive care/therapy).

The presentation will highlight initial results from a Phase II randomized clinical trial highlighting the superior cellular immune response of GEO-CM04S1 compared to an authorized mRNA-based COVID-19 vaccine in CLL patients—a population known to exhibit suboptimal protective responses to COVID-19 and other vaccines due to immune dysfunction. The findings will underscore the differentiated mechanism and clinical potential of the GeoVax MVA multi-antigen platform, particularly in immunocompromised individuals.

“GEO-CM04S1 continues to show promise as a vaccine option for populations with suboptimal protection from existing COVID-19 vaccines,” said Kelly T. McKee, Jr., M.D., Chief Medical Officer of GeoVax. “We are proud to have these important data showcased at EHA2025, reflecting the real-world needs of patients with hematologic malignancies.”

About GEO-CM04S1

GEO-CM04S1 is a multi-antigen COVID-19 vaccine designed using a synthetic Modified Vaccinia Ankara (MVA) vector platform. The vaccine expresses both spike (S) and nucleocapsid (N) antigens of SARS-CoV-2, aiming to provide broader and more durable immune protection. It is currently being evaluated in Phase 2 clinical trials in both immunocompromised and healthy adults.

About GeoVax

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

Company Contact:                 

info@geovax.com                   

678-384-7220                          

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Concentra Biosciences to Acquire Elevation Oncology in Strategic Biotech Merger

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Concentra Biosciences is acquiring Elevation Oncology for $0.36 per share in cash plus a CVR tied to future financial milestones.
– Elevation’s board supports the deal; insiders holding 5.1% have committed to tender their shares.
– Shareholders could earn additional payouts based on net cash reserves and proceeds from potential asset sales.

In a strategic move within the biotech sector, Concentra Biosciences has announced plans to acquire Elevation Oncology, a clinical-stage oncology firm known for its targeted cancer therapies. The transaction, which was unveiled Monday, values Elevation at $0.36 per share in cash. In addition to the upfront payment, shareholders will receive a contingent value right (CVR) tied to future financial outcomes.

This acquisition marks a significant shift for Elevation Oncology, which has focused its efforts on developing precision treatments for solid tumors with limited current treatment options. The deal aligns with Concentra’s expansion strategy in oncology innovation, particularly in addressing high-need patient populations.

Under the terms of the agreement, Elevation stockholders will receive a cash payout of $0.36 per share, with an additional CVR providing potential future compensation. The CVR includes two main components: shareholders could benefit from any closing cash above $26.4 million and from a share of future net proceeds related to the disposition of EO-1022, a clinical asset, if sold within a year of closing. The CVR will remain active for up to five years following the merger.

Elevation’s board of directors has unanimously backed the agreement, emphasizing that the proposed terms serve the best interest of shareholders. A wholly owned subsidiary of Concentra is expected to begin a formal tender offer by June 23, 2025. For the acquisition to proceed, a majority of Elevation’s outstanding shares must be tendered, and at least $26.4 million in net cash must remain on hand after deducting liabilities, transaction costs, and specific payments.

Support for the deal is already emerging. Elevation’s leadership and certain insiders, who collectively own about 5.1% of the company’s shares, have signed agreements to support and tender their holdings. If all conditions are met, the merger is expected to finalize by July 2025.

The acquisition arrives at a pivotal moment for Elevation Oncology. The company has faced challenges navigating the complex landscape of cancer drug development and commercialization. Partnering with Concentra provides a pathway to both secure value for current shareholders and potentially advance EO-1022 and other clinical assets under stronger financial and operational support.

Legal counsel for Elevation Oncology is being provided by Fenwick & West LLP, while Gibson, Dunn & Crutcher LLP is advising Concentra.

This merger is part of a broader trend in the biotech sector, where companies with innovative pipelines seek strategic partnerships or acquisitions to accelerate growth and mitigate risk. For Concentra, the deal expands its reach into solid tumor therapeutics—a market with both high clinical need and strong commercial potential.

As the healthcare sector continues to evolve, this acquisition underscores the importance of collaboration in bringing forward novel cancer treatments and delivering shareholder value in a highly competitive and capital-intensive industry.

Take a moment to take a look at Noble Capital Markets’ Biotechnology and Life Sciences Research Analyst Robert Leboyer’s coverage list.

Release – Unicycive Provides Update on New Drug Application for Oxylanthanum Carbonate to Treat Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

June 10, 2025 6:00am EDT Download as PDF

– The U.S. Food and Drug Administration (FDA) identified deficiencies at a third-party manufacturing vendor

– FDA to provide final decision by PDUFA action date of June 28, 2025

LOS ALTOS, Calif., June 10, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY or the “Company”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced an update on its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

The FDA communicated to the Company that it had identified deficiencies in cGMP compliance at a third-party manufacturing vendor (one of its CDMO’s third-party subcontractors and not its Drug Substance vendor) following an FDA inspection.

The FDA indicated that, given the identified deficiencies, any label discussions between the FDA and the Company are precluded. The Company has responded to all FDA information requests and expects a final decision from the FDA by the PDUFA action date of June 28, 2025.

“We are discussing with our partners to help resolve FDA’s concerns and remain confident in the promise of OLC based on the extensive clinical and preclinical data we’ve generated,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “We believe OLC is a promising new treatment option and we are eager to bring it as quickly as we can to patients with CKD on dialysis who are living with hyperphosphatemia.”

About Oxylanthanum Carbonate (OLC)
OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden.

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.2 Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

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; 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.

1 Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2. PMID: 15284307.
2 Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145. Epub 2023 Jun 29. PMID: 37229723; PMCID: PMC10371371.

Investor Contact:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Media Contact:
Rachel Visi
Real Chemistry
redery@realchemistry.com

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Source: Unicycive Therapeutics, Inc.

Released June 10, 2025

Release – Nutriband Announces U.S. Patent Issued for Its Transdermal Abuse Deterrent Technology

Posted on by aweinsoff@channelchek.com

Research News and Market Data on NTRB

June 09, 2025 07:30 ET 

Patent issuance expands United States patent coverage for AVERSA™ transdermal abuse deterrent technology

AVERSA™ transdermal abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

ORLANDO, Fla., June 09, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that the United States Patent and Trademark Office (USPTO) issued patent number 12,318,492 on June 3, 2025, entitled “Abuse and Misuse Deterrent Transdermal Systems.”
The issuance of this patent further expands Nutriband’s intellectual property protection in the United States for its portfolio of abuse deterrent transdermal products based on its proprietary Aversa™ abuse deterrent technology. This technology can be incorporated into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential.

The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

Nutriband’s lead product under development is Aversa™ Fentanyl, an abuse deterrent fentanyl transdermal system, with the potential to become the first abuse deterrent pain patch on the market with peak annual US sales estimated to be$80 million to $200 million.1

__________________________________________

1 Health Advances Aversa Fentanyl market analysis report 2022

About AVERSA™ Abuse-Deterrent Transdermal Technology

Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

About Nutriband Inc.

We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Forms 10-K and 10-Q’s, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Contact Information:

Nutriband Inc.
Phone: 407-377-6695
Email: info@nutriband.com

Release – GeoVax Highlights Broad Cross-Protective Immunity of Multi-Antigen COVID-19 Vaccine Candidates at Keystone Symposia

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Preclinical Studies Demonstrate Durable Protection Against SARS-CoV-2 Variants, Including Omicron XBB.1.5, Driven by T-Cell Responses

ATLANTA, GA, June 9, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and multi-antigen vaccines against infectious diseases and solid tumors, today recapped two scientific poster presentations delivered at the Keystone Symposia on Vaccinology: Horizons Across Disease, Demography and Technology, held June 4–7, 2025, in Washington, D.C.

The presentations, titled MVA-Vectored Multi-Antigen COVID-19 Vaccines Induce Protective Immunity Against SARS-CoV-2 Variants Spanning Alpha to Omicron in Preclinical Animal Models, and GEO-CM04S1 Vaccine Candidate Maintains Potent Cross-Reactivity Against Original SARS-CoV-2 B.1 and Omicron Subvariant XBB.1.5, were delivered by Drs. Pratima Kumari and Amany Elsharkawy, respectively, members of GeoVax’s scientific team and its collaborators, during the June 5 and June 6 poster sessions. The presentations spotlight the Company’s Modified Vaccinia Ankara (MVA)-vectored COVID-19 vaccine candidates, GEO-CM04S1 and GEO-CM02, and their ability to induce durable, cross-reactive immunity against SARS-CoV-2 variants in preclinical animal models. These studies underscore the immunologic breadth, durability, and cross-variant protection of GeoVax’s multi-antigen design strategy—especially important for addressing variant evasion and suboptimal immune response in vulnerable patient populations.

Key Findings from Studies

GEO-CM02 Study – Poster #1050 | Presenter: Dr. Pratima Kumari, GeoVax Scientist

This presentation detailed findings for GEO-CM02, a multi-antigen MVA-based vaccine expressing the spike (S), membrane (M), and envelope (E) proteins.

  • In hACE2 mouse models, a single dose provided complete protection against both the original Wuhan strain and the Omicron BA.1 variant.
  • Two-dose regimens generated high neutralizing antibody levels, reduced viral loads in lung and brain tissues, and lowered inflammatory markers- indicating enhanced immune memory.
  • Notably, early protection was achieved prior to detectable neutralizing antibodies, further supporting the role of innate and cellular immune responses in viral control. This underscores the value of the multi-antigen MVA-based vaccine platform, particularly as the virus continues to mutate.

GEO-CM04S1 Study – Poster #2047 | Presenter: Dr. Amany Elsharkawy, Georgia State University Scientist

This study evaluated the immunogenicity and protective efficacy of GEO-CM04S1, an MVA-vectored vaccine co-expressing spike (S) and nucleocapsid (N) proteins, in a K18-hACE2 mouse model. Mice were challenged intranasally with either the original B.1 strain or the Omicron XBB.1.5 subvariant.

  • GEO-CM04S1 conferred full protection against clinical disease, lung injury, and inflammation in both viral challenge models.
  • Despite the absence of detectable neutralizing antibodies against XBB.1.5, vaccinated animals were fully protected, suggesting antibody-independent protection.
  • Immune cell depletion studies revealed that CD4+ T cells, not B cells or CD8+ T cells, were critical for protection, highlighting the vaccine’s ability to drive T cell–mediated immunity across variants.

“These experimental findings document the value of inducing broadly specific immune responses to protect against evolving SARS-CoV-2 variants,” said Mark Newman, PhD, Chief Scientific Officer of GeoVax. “We believe the use of multi-antigen vaccines could provide significant benefit by limiting the need to continually update COVID vaccines and by limiting the need for yearly booster doses.” 

GeoVax’s MVA vaccine platform is designed to address gaps in pandemic preparedness and public health resilience, with lead vaccine candidate GEO-CM04S1 currently being evaluated in multiple Phase 2 clinical trials for COVID-19.

About GEO-CM04S1

GEO-CM04S1 is a synthetic next-generation, multi-antigen MVA-vectored COVID-19 vaccine co-expressing spike (S) and nucleocapsid (N) antigens, designed to induce both broad antibody and T-cell responses. It is being evaluated in three ongoing Phase 2 clinical trials:

  1. A primary vaccine for immunocompromised individuals (e.g., post-transplant, CAR-T, or hematologic cancers)
  2. A booster for patients with chronic lymphocytic leukemia (CLL)
  3. A booster for healthy adults previously immunized with 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. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

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

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

Company Contact:                 

info@geovax.com                   

678-384-7220                          

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

MAIA Biotechnology (MAIA) – THIO Update Shows Another Increase In Overall Survival

Posted on by slightbourne@noblecapitalmarkets.com


Friday, June 06, 2025

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 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.

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.

New THIO-101 Update Presented AT ASCO. MAIA presented updated data from its THIO-101 trial showing median overall survival increased as more patients advanced through treatment. Data presented showed a median overall survival of 17.8 months for patients receiving the combination of THIO and the PD-1 inhibitor, Libtayo (cemiplimab, a checkpoint inhibitor from Regeneron), an increase from 16.9 months reported in January 2025.

Survival Improved As More Patients Completed The Study. Updated data was presented at the American Society for Clinical Oncology (ASCO) 2025 Annual Meeting, with more patients treated for longer periods. The median overall survival reported was 17.8 months compared with the expected survival of 5.8 months for standard of care therapy. This was an improvement from 16.9 months (n=22 patients) reported in January 2025 and 10.6 months (n=19 patients) reported in August 2024.


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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.