Tag: Biotechnology

Release – MAIA Biotechnology Welcomes Leading Hepatocellular Carcinoma Clinician-Scientists to Scientific Advisory Board

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

June 24, 2025 8:15am EDT Download as PDF

Planning for Phase 2 clinical trial in hepatocellular carcinoma (HCC) underway

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced the appointment of two prominent oncologists to its Scientific Advisory Board (SAB), Claudia Fulgenzi, MD, and David J. Pinato, MD, MRCP (UK), PhD. Both are specialists in hepatocellular carcinoma (HCC), a tumor type to be studied in future clinical trials of MAIA’s lead candidate ateganosine (THIO) sequenced with a checkpoint inhibitor.

As SAB members they will advise MAIA on designs and protocols for its company sponsored trial (CST) in HCC and may participate in future investigator sponsored trials (IST).

“Drs. Pinato and Fulgenzi are scientific experts on inflammation as a pathogenic and prognostic mechanism in primary liver cancers. Together, their research has focused on improving the treatment of HCC, particularly with the use of anti-cancer immunotherapy,” said MAIA Chairman and CEO Vlad Vitoc, M.D. “They will bring a wealth of knowledge to our SAB, with specialized expertise that will inform our plans and preparations for our upcoming clinical program in HCC.

“By the end of this year, we expect to have all required approvals to begin enrolling patients in a HCC trial,” Dr. Vitoc added.

MAIA was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for ateganosine as a treatment for HCC in 2022. ODDs can provide up to seven years of market exclusivity.

Dr. David Pinato is a clinician scientist in the Department of Surgery and Cancer at Imperial College London and a consultant oncologist at Imperial College Healthcare NHS Trust. As Director of Developmental Cancer Therapeutics at Imperial College, he leads a translational research program focused on the early clinical implementation of novel experimental anticancer therapies with particular emphasis on anti-cancer immunotherapy.

Dr. Pinato’s research efforts in liver cancer have been recognized by the American Society of Clinical Oncology (ASCO) and the Society for Immunotherapy of Cancer (SITC). He has received awards by the British Society of Pharmacology and the Royal Society of Medicine, and fellowships by the European School of Oncology and Fulbright Program.

Dr. Pinato completed his core medical training across some of the busiest acute hospitals in London and was elected to the Royal College of Physicians (MRCP). His research has been published in leading journals in the field including the Journal of Clinical Oncology, Annals of Oncology, Hepatology and many others. Dr. Pinato lectures internationally in the field of molecular oncology with a specific interest in HCC and acts as a reviewer for several peer-reviewed journals including The Lancet, Cancer Discovery, Hepatology and Journal of Hepatology.

Dr. Claudia Fulgenzi is a specialist in medical oncology at Imperial College London, with dedicated professional interest in the field of immune-oncology and gastro-intestinal cancers, particularly hepatic-biliary malignancies. Dr. Fulgenzi graduated in medicine from the University of Rome Tor Vergata and subsequently specialized in medical oncology at the University Campus Bio Medico of Rome, Italy. Her contributions to the field have been recognized with prestigious awards including the ASCO Merit Award, the Young Investigator award by the International Liver Cancer Association (ILCA) and the American Society of Clinical Oncology.

Dr. Fulgenzi is actively engaged in clinical practice in London, serving as an honorary consultant in oncology at Chelsea and Westminster Hospital and as a specialty doctor in the early phase clinical trial unit at Hammersmith Hospital. In these capacities, she conducts clinical and translational research, contributes to clinical trial design, and provides expert medical guidance to cancer patients.

Hepatocellular carcinoma is the most frequently occurring primary liver tumor representing approximately 90% of all liver cancers. HCC currently ranks 5th by incidence and 3rd by mortality on a global scale.

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

Source: MAIA Biotechnology, Inc.

Released June 24, 2025

Release – Carisma Therapeutics and OrthoCellix Enter into Definitive Merger Agreement to Create Company Focused on Regenerative Cell Therapies for Orthopedic Diseases

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

June 23, 2025

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  • Proposed reverse merger with OrthoCellix, a wholly-owned subsidiary of Ocugen, to create Nasdaq-listed, late clinical-stage regenerative cell therapy company with a first-in-class technology platform, focused on orthopedic diseases
  • OrthoCellix is developing the Phase 3-ready NeoCart® as an autologous cartilage implant technology utilizing patient cells to repair articular cartilage defects of the knee

PHILADELPHIA and MALVERN, Pa., June 23, 2025 (GLOBE NEWSWIRE) — Carisma Therapeutics Inc. (Nasdaq: CARM) (Carisma) and OrthoCellix, Inc. (OrthoCellix), a wholly-owned subsidiary of Ocugen, Inc. (Nasdaq: OCGN) (Ocugen), a clinical-stage company developing regenerative cell therapies for orthopedic diseases, today jointly announced that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on the development of OrthoCellix’s NeoCart® technology for the treatment of knee articular cartilage defects and plans to initiate a U.S. Food and Drug Administration (FDA)-endorsed Phase 3 clinical trial for NeoCart®.

“We believe merging OrthoCellix with Carisma will allow us to create a publicly-traded company focused on the development of NeoCart® and provide value for both Ocugen and Carisma stockholders while unlocking true market potential of NeoCart®,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-founder of Ocugen. “We believe NeoCart® has tremendous potential to deliver a truly transformative approach to cartilage repair, and we’ve established OrthoCellix with dedicated resources to bring this revolutionary technology to the patients who desperately need it.”

“Carisma evaluated a range of strategic alternatives, and we believe this proposed transaction represents an opportunity to deliver significant value to our stockholders,” said Steven Kelly, President and Chief Executive Officer, of Carisma. “OrthoCellix is strongly positioned with its NeoCart® platform, a dedication to developing regenerative cell therapies, and a well-credentialed management team to lead the combined company.”

About OrthoCellix’s NeoCart® Portfolio

OrthoCellix is developing NeoCart® as an autologous cartilage implant technology utilizing patient cells to repair articular cartilage defects of the knee. The novel platform merges a fortified 3D scaffold and patented bioprocessing technology to grow chondrocytes—the cells responsible for maintaining cartilage health—to produce adolescent-like cartilage at the time of implant. NeoCart® has the potential to accelerate healing and reduce pain by creating a similar, functional joint surface to help patients return to normal activities and prevent complications associated with articular cartilage damage.

OrthoCellix anticipates launching its Phase 3 clinical trial by the end of 2025. Previously, NeoCart® received Regenerative Medicine Advanced Therapy (RMAT) designation and concurrence from the FDA on a single, confirmatory Phase 3 clinical trial to enable submission of a Biologics License Application.

About the Proposed Transactions

Under the terms of the merger agreement, OrthoCellix will merge with and into a wholly-owned subsidiary of Carisma, with OrthoCellix continuing as a wholly-owned subsidiary of Carisma and the surviving company of the Merger. Carisma will issue to the pre-merger OrthoCellix stockholder shares of Carisma common stock as merger consideration in exchange for the cancellation of shares of capital stock of OrthoCellix. Carisma also expects to enter into subscription agreements for a private financing with Ocugen and other select investors, which is expected to close concurrently with the completion of the merger, to enable the combined company to complete the Phase 3 trial of NeoCart® without any additional cost or investment from Ocugen. In connection with the closing of the proposed transactions, Carisma stockholders will be issued contingent value rights representing the right to receive certain payments from proceeds received by the combined company, if any, related to Carisma’s pre-transaction legacy assets.

Under the terms of the merger agreement, upon the closing of the proposed transactions and after giving effect to the contemplated $25.0 million concurrent financing, OrthoCellix’s stockholder and the other participants in the concurrent financing are expected to own approximately 90% of the combined company, and existing Carisma stockholders are expected to own approximately 10% of the combined company, each on a fully diluted basis. The percentage of the combined company that each company’s former stockholders will own after completion of the merger is subject to adjustment based on Carisma’s net cash at the closing and the proceeds from the concurrent financing, among other adjustments, in each case as described in the merger agreement.

Upon the closing of the proposed transactions, “Carisma Therapeutics Inc.” is expected to be renamed “OrthoCellix, Inc.” and trade on the Nasdaq Capital Market under the ticker symbol ‘OCLX.’

The transaction has been unanimously approved by the board of directors of both companies and is expected to close in the second half of 2025, subject to customary closing conditions, including approvals by the stockholders of each company and the effectiveness of a registration statement to be filed with the Securities and Exchange Commission (the “SEC”) to register the shares of Carisma common stock to be issued in connection with the merger. In connection with the companies’ entry into the merger agreement, directors and officers of Carisma and OrthoCellix’s stockholder have executed support agreements, pursuant to which they have agreed to vote all of their shares of capital stock in favor of the merger or the issuance of Carisma equity in the merger, as applicable.

Advisors

Wilmer Cutler Pickering Hale and Dorr LLP is serving as legal counsel to Carisma and Lucid Capital Markets, LLC is providing a fairness opinion to Carisma’s board of directors. Chardan Capital Markets LLC is serving as M&A advisor and co-placement agent to OrthoCellix and Ocugen. Lake Street Capital Markets, LLC is co-placement agent to OrthoCellix, as a subsidiary of Ocugen, Goodwin Procter LLP is serving as legal counsel to Ocugen and OrthoCellix, and Paul Hastings LLP is serving as legal counsel to the placement agents.

About OrthoCellix

OrthoCellix is a regenerative cell therapy company dedicated to developing a first-in-class technology platform focused on cartilage defects and other orthopedic diseases to address considerable unmet medical needs. The lead program within OrthoCellix is NeoCart® with revolutionary 3D cell therapy technology designed to repair and restore articular cartilage defects in the knee. The Company has a pipeline of additional treatments based on its proprietary scaffold bioreactor and adhesive. OrthoCellix will utilize the Good Manufacturing Practice facility established by Ocugen to support OrthoCellix’s initial development of NeoCart®.

About Carisma Therapeutics

Carisma Therapeutics is a biotechnology company pioneering macrophage engineering to develop groundbreaking therapies for fibrosis and cancer. With a strong commitment to patient-centric innovation, Carisma aims to deliver scalable, next-generation solutions that transform treatment paradigms. Carisma is headquartered in Philadelphia, PA. For more information, please visit www.Carismatx.com.

Cautionary Note on Forward- Looking Statements

Certain statements in this communication, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the “safe harbor” provisions under the Private Securities Litigation Reform Act of 1995, concerning Carisma, OrthoCellix, the proposed financing and the proposed merger between Carisma and OrthoCellix (collectively, the “Proposed Transactions”) and other matters. These forward-looking statements include, but are not limited to, express or implied statements relating to Carisma’s and OrthoCellix’s management teams’ expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: the structure, timing and completion of the proposed merger by and between Carisma and OrthoCellix; the Proposed Transactions and the expected effects, perceived benefits or opportunities of the Proposed Transactions; the combined company’s listing on Nasdaq after the closing of the Proposed Transactions; expectations regarding the structure, timing and completion of a concurrent financing, including investment amounts from investors, timing of closing of the Proposed Transactions, expected proceeds, expectations regarding the use of proceeds, and impact on ownership structure; the anticipated timing of the closing; the expected executive officers and directors of the combined company; each company’s and the combined company’s expected cash position at the closing and cash runway of the combined company following the proposed merger and any private financing; the future operations of the combined company, including research and development activities; the nature, strategy and focus of the combined company; the development and commercial potential and potential benefits of any product candidates of the combined company, including expectations around market exclusivity and intellectual property protection; anticipated clinical drug development activities and related timelines, including the expected timing for announcement of data and other clinical results; expectations regarding or plans for discovery, preclinical studies, clinical trials and research and development programs, in particular with respect to NeoCart®, and any developments or results in connection therewith, including the target product profile of NeoCart®; the anticipated timing of the commencement of and results from those studies and trials; the sufficiency of post-transaction resources to support the advancement of OrthoCellix’s pipeline through certain milestones and the time period over which OrthoCellix’s post-transaction capital resources will be sufficient to fund its anticipated operations; the cash balance of the combined entity at closing; expectations related to the anticipated timing of the closing of the Proposed Transactions (the “Closing”); the expectations regarding the ownership structure of the combined company; the expected trading of the combined company’s stock on Nasdaq under the ticker symbol “OCLX” after the Closing; and other statements that are not historical fact. All statements other than statements of historical fact contained in this communication are forward-looking statements. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “opportunity,” “potential,” “milestones,” “pipeline,” “can,” “goal,” “strategy,” “target,” “anticipate,” “achieve,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “possible,” “project,” “should,” “will,” “would” and similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are made based on current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management, concerning future developments and their potential effects. There can be no assurance that future developments affecting Carisma, OrthoCellix, or the Proposed Transactions will be those that have been anticipated.

These forward-looking statements involve a number of risks and uncertainties, some of which are beyond Carisma’s or OrthoCellix’s control, or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the conditions to the Closing or consummation of the Proposed Transactions are not satisfied, including the failure to timely obtain approval of the proposed reverse stock split from Carisma’s stockholders and the proposed merger from both Carisma’s and OrthoCellix’s stockholders, if at all; the risk that the proposed concurrent financing is not completed in a timely manner, if at all; uncertainties as to the timing of the consummation of the Proposed Transactions and the ability of each of Carisma and OrthoCellix to consummate the Proposed Transactions; risks related to Carisma’s continued listing on Nasdaq until closing of the Proposed Transactions and the combined company’s ability to remain listed following the Closing; risks related to Carisma’s and OrthoCellix’s ability to correctly estimate their respective operating expenses and their respective expenses associated with the Proposed Transactions, as applicable, pending the Closing, as well as uncertainties regarding the impact any delay in the Closing would have on the anticipated cash resources of the combined company, and other events and unanticipated spending and costs that could reduce the combined company’s cash resources; risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the Proposed Transactions; the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the merger agreement; the effect of the announcement or pendency of the merger on Carisma’s or OrthoCellix’s business relationships, operating results and business generally; costs related to the merger; the risk that as a result of adjustments to the exchange ratio, OrthoCellix stockholders and Carisma stockholders could own more or less of the combined company than is currently anticipated; risks related to the market price of Carisma’s common stock relative to the value suggested by the exchange ratio; the uncertainties associated with OrthoCellix’s NeoCart® portfolio, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the completion of clinical trials; risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance these product candidates; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from product candidates being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; the outcome of any legal proceedings that may be instituted against Carisma, OrthoCellix or any of their respective directors or officers related to the Proposed Transactions; the ability of Carisma and OrthoCellix to obtain, maintain, and protect their respective intellectual property rights; competitive responses to the Proposed Transactions; costs of the Proposed Transactions and unexpected costs, charges or expenses resulting from the Proposed Transactions; potential adverse reactions or changes to business relationships, operating results, and business generally, resulting from the announcement or completion of the Proposed Transactions; changes in regulatory requirements and government incentives; risks associated with the possible failure to realize, or that it may take longer to realize than expected, certain anticipated benefits of the Proposed Transactions, including with respect to future financial and operating results, legislative, regulatory, political and economic developments, and those uncertainties and factors; and the risk of involvement in litigation, including securities class action litigation, that could divert the attention of the management of Carisma or the combined company, harm the combined company’s business and may not be sufficient for insurance coverage to cover all costs and damages, among others. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the SEC, including the factors described in the section titled “Risk Factors” in Carisma’s Annual Report on Form 10-K for the year ended December 31, 2024, which was originally filed with the SEC on March 31, 2025, as amended by Amendment No. 1 to the Annual Report on Form 10-K/A, which was filed with the SEC on April 29, 2025, subsequent Quarterly Reports on Form 10-Q filed with the SEC, and in other filings that Carisma makes and will make with the SEC in connection with the Proposed Transactions, including the Form S-4 and Proxy Statement described below under “Additional Information and Where to Find It”, as well as discussions of potential risks, uncertainties, and other important factors included in other filings by Carisma from time to time, any risk factors related to Carisma or OrthoCellix made available to you in connection with the Proposed Transactions, as well as risk factors associated with companies, such as OrthoCellix, that operate in the biopharma industry. Should one or more of these risks or uncertainties materialize, or should any of Carisma’s or OrthoCellix’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this communication, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Neither Carisma nor OrthoCellix undertakes or accepts any duty to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based, except as required by law. This communication does not purport to summarize all of the conditions, risks and other attributes of an investment in Carisma or OrthoCellix.

No Offer or Solicitation

This communication and the information contained herein is not intended to and does not constitute (i) a solicitation of a proxy, consent or approval with respect to any securities or in respect of the Proposed Transactions or (ii) an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities pursuant to the Proposed Transactions or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law, or an exemption therefrom. Subject to certain exceptions to be approved by the relevant regulators or certain facts to be ascertained, the public offer will not be made directly or indirectly, in or into any jurisdiction where to do so would constitute a violation of the laws of such jurisdiction, or by use of the mails or by any means or instrumentality (including without limitation, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or any facility of a national securities exchange, of any such jurisdiction.

NEITHER THE SEC NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THE SECURITIES OR DETERMINED IF THIS COMMUNICATION IS TRUTHFUL OR COMPLETE.

Important Additional Information about the Proposed Transactions Will be Filed with the SEC

This communication relates to the proposed merger involving Carisma and OrthoCellix and may be deemed to be solicitation material in respect of the proposed merger. In connection with the Proposed Transactions, Carisma intends to file relevant materials with the SEC, including a registration statement on Form S-4 (the “Form S-4”) that will contain a proxy statement (the “Proxy Statement”) and prospectus. This communication is not a substitute for the Form S-4, the Proxy Statement or for any other document that Carisma may file with the SEC and/or send to Carisma’s stockholders in connection with the proposed merger. CARISMA URGES, BEFORE MAKING ANY VOTING DECISION, INVESTORS AND STOCKHOLDERS TO READ THE FORM S-4, THE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT CARISMA, ORTHOCELLIX, THE PROPOSED TRANSACTIONS AND RELATED MATTERS.

Investors and stockholders will be able to obtain free copies of the Form S-4, the Proxy Statement and other documents filed by Carisma with the SEC (when they become available) through the website maintained by the SEC at www.sec.gov. Copies of the documents filed by Carisma with the SEC will also be available free of charge on Carisma’s website at www.carismatx.com, or by contacting Carisma’s Investor Relations at investors@Carismatx.com. In addition, investors and stockholders should note that Carisma communicates with investors and the public using its website at https://ir.Carismatx.com/.

Participants in the Solicitation

Carisma, OrthoCellix, and their respective directors and certain of their executive officers and other members of management may be deemed to be participants in the solicitation of proxies from Carisma’s stockholders in connection with the Proposed Transactions under the rules of the SEC. Information about Carisma’s directors and executive officers, including a description of their interests in Carisma, is included in Carisma’s most recent Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025, as amended by Amendment No. 1 to the Annual Report on Form 10-K, which was filed with the SEC on April 29, 2025. Additional information regarding the persons who may be deemed participants in the proxy solicitations, including about the directors and executive officers of OrthoCellix, and a description of their direct and indirect interests, by security holdings or otherwise, will also be included in the Form S-4, the Proxy Statement and other relevant materials to be filed with the SEC when they become available. These documents can be obtained free of charge from the sources indicated above.

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

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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