Tag: Biotech

Release – MAIA Biotechnology Activates and Opens Enrollment at Second U.S. Clinical Site for International Phase 2 THIO-101 Expansion Trial

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June 10, 2026 9:15am EDT

Additional data from MAIA’s THIO-101 expansion may further support an accelerated approval filing with the FDA

Potential breakthrough therapy holds substantial commercial opportunity in a projected $70 billion global non-small cell lung cancer market by 20301

CHICAGO, June 10, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that it has activated the second U.S. clinical site in its Phase 2 THIO-101 expansion trial at Central Alabama Research in Homewood, Alabama. The expansion part of THIO-101 evaluates MAIA’s lead investigational therapy, ateganosine, a dual-action molecule incorporating telomere targeting and immunogenicity, as a third-line (3L) treatment for non-small cell lung cancer (NSCLC) in patients who have previously failed treatment with checkpoint inhibitors (CPIs) and chemotherapy.

Parts A and B of the Phase 2 THIO-101 Phase 2 trial provided key inputs for MAIA’s market strategy by identifying optimal dosing for a well-defined patient population. The THIO-101 expansion trial is ongoing in Europe and Asia with 44 active sites in 6 countries along with 2 in the U.S. The additional data from the trial’s expansion may further support an accelerated approval filing with the FDA.

“Adding our second U.S. site reflects strong execution of our clinical strategy and continued momentum in the expansion of the THIO-101 trial,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “Broadening our site footprint enables more efficient patient enrollment as we advance the program under the FDA Fast Track designation and work toward upcoming interim data milestones.”

David J. Mooney, M.D., oncology physician at Central Alabama Research and principal investigator for THIO-101 in Alabama commented, “We look forward to bringing ateganosine treatment to our cancer center. There’s a large regional patient pool across the Southeast, including underserved and rural populations, that can greatly benefit from a novel therapy in this hard-to-treat NSCLC setting with very limited treatment options.”

In parallel with the Phase 2 clinical trial, MAIA is actively screening and enrolling patients in a pivotal Phase 3 clinical trial designed to assess overall survival for ateganosine sequenced with a CPI compared to investigator’s choice of chemotherapy in a 1:1 randomization of up to 300 patients. MAIA has received regulatory approval to screen patients in Taiwan, Turkey, select European Medicines Agency (EMA) countries, and Georgia.

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 THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

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
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GSK Pays $10.6 Billion for Nuvalent in Its Largest Acquisition in Over a Decade

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The biotech acquisition market just recorded one of its most significant transactions of 2026. GSK (LSE/NYSE: GSK) announced Tuesday it has entered into a definitive agreement to acquire Nuvalent Inc. (Nasdaq: NUVL), a Cambridge, Massachusetts-based clinical-stage biopharmaceutical company focused on precision oncology, for $10.6 billion in an all-cash tender offer at $124 per share. The price represents a 40% premium to Nuvalent’s last closing price and a 26% premium to its 30-day volume-weighted average price. Net of cash acquired, GSK’s aggregate investment is approximately $9.4 billion.

Nuvalent shares surged nearly 40% in premarket trading. GSK shares slipped approximately 1.5% in London as the market processed the scale of the commitment.

The deal marks GSK’s largest acquisition in more than a decade and the first major transaction under the leadership of new CEO Luke Miels, who took over from Emma Walmsley in January 2026. It signals a deliberate strategic pivot — GSK is moving aggressively into oncology as it confronts patent expiration pressures on established products, including its blockbuster shingles vaccine Shingrix, and seeks to close the gap with rival AstraZeneca, whose oncology sales accounted for 44% of total revenue last year.

What GSK Is Actually Buying

Founded in 2017, Nuvalent has built its pipeline around precisely targeted therapies for non-small cell lung cancer, one of the largest and most commercially significant oncology indications globally. Its two lead assets are zidesamtinib, a ROS1 inhibitor, and neladalkib, an ALK inhibitor — both of which have received FDA Breakthrough Therapy Designation and Orphan Drug Status and are currently under active FDA review.

FDA target decision dates are September 18, 2026 for zidesamtinib and November 27, 2026 for neladalkib. Subject to approval, both drugs are expected to launch before year-end 2026, with combined peak annual sales potential estimated at $3 billion to $4 billion. The pipeline also includes NVL-330, a potential best-in-class HER2 inhibitor currently in Phase I trials for HER2-altered non-small cell lung cancer, adding a third growth platform beyond the two near-term approvals.

GSK expects the acquisition to be accretive to sales and core operating profit in 2027 and accretive to core earnings per share in 2029, inclusive of synergies and pipeline reprioritization. The company plans to complement Nuvalent’s lung cancer platform with its own Ris-Rez B7-H3 antibody-drug conjugate, creating an integrated oncology franchise in one of the sector’s highest-priority therapeutic areas.

The Small Cap Biotech Signal

GSK paying $10.6 billion for a clinical-stage company with no approved products and no commercial revenue carries a specific and powerful message for small and microcap biotech investors. The premium reflects the value of FDA Breakthrough Therapy Designation, validated mechanism of action, late-stage regulatory visibility, and a clearly defined commercial opportunity in a large patient population.

The broader biotech M&A environment is accelerating. Patent cliffs across major pharmaceutical companies are creating urgency to acquire external innovation, and the pipeline of clinical-stage companies with validated oncology assets in the sub-$2 billion market cap range remains deep. When large pharma assigns a $10.6 billion value to a pre-revenue biotech, it resets the reference point for how the market values similar-stage assets across the sector.

Upon completion of the tender offer and merger, Nuvalent common stock will be delisted from Nasdaq.

Release – Eledon Announces Updated Data from Investigator-Initiated Islet Transplant Trial of Tegoprubart in Patients with Type 1 Diabetes (T1D) at UChicago Medicine

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June 8, 2026

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– All 12 patients in study (100%) achieved insulin independence, producing their own insulin and no longer requiring exogenous insulin therapy to manage their T1D

– All 12 patients also achieved an HbA1c below 6.5%, with a mean most recent HbA1c of approximately 5.4%, representing an approximately 2.6% average improvement in HbA1c from baseline

– No severe hypoglycemic episodes were reported post-transplant, compared with a history of recurrent severe hypoglycemic events prior to transplantation in all enrolled patients

IRVINE, Calif., June 08, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced updated results from an investigator-initiated trial evaluating tegoprubart, its investigational anti-CD40L antibody, as part of a calcineurin inhibitor-free immunosuppression regimen in patients with type 1 diabetes undergoing allogeneic islet cell transplantation at the University of Chicago Medicine Transplant Institute. The results were presented by trial investigator Piotr Witkowski, M.D., Ph.D., Director of the Pancreas and Islet Transplant Program at UChicago Medicine, at the American Diabetes Association 86th Scientific Sessions, taking place June 5-9, 2026, in New Orleans, Louisiana.

All patients treated in the study (n=12) showed rapid improvement in glycemic control following islet transplantation and treatment with tegoprubart, with stable islet graft function observed across the cohort over a median and maximum post-transplant follow-up period of 8 and 22 months, respectively. All 12 patients achieved insulin independence, meaning that they no longer needed chronic, exogenous insulin therapy to manage their T1D. Also, all patients demonstrated a most recent hemoglobin A1C (“HbA1c”) below the diabetic threshold of 6.5%, with a mean most recent HbA1c of approximately 5.4% across the cohort.

While all patients enrolled reported recurrent severe hypoglycemic events pre-transplant, no severe hypoglycemic episodes were reported following transplantation. Severe hypoglycemia is a serious complication of type 1 diabetes that may require emergency medical intervention and can cause loss of consciousness, seizures, injury, or death. Recurrent severe hypoglycemic episodes can significantly impact patients’ daily activities and quality of life.

Higher levels of post-transplant islet cell engraftment were observed with the tegoprubart-based immunosuppression regimen than in historical patients treated with a tacrolimus-based immunosuppression regimen at UChicago Medicine. There were no rejection episodes, and no patients developed de novo donor-specific HLA antibodies. Tegoprubart-based immunosuppression was generally well tolerated, with immunosuppression-related adverse events generally successfully treated by lowering the mycophenolic acid dose, if necessary. Additionally, no evidence of nephrotoxicity, hypertension or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, was observed. These findings further support the potential of CD40L blockade to enable effective islet graft protection while avoiding the toxicities of calcineurin inhibitors such as tacrolimus.

The investigator-initiated pilot study enrolled 12 adults with long-standing T1D undergoing allogeneic islet transplantation at UChicago Medicine with a median duration of diabetes of approximately 33 years and mean HbA1c of approximately 8.0% prior to transplantation. Participants received tegoprubart, as part of a calcineurin inhibitor-free immunosuppression regimen. Calcineurin inhibitors such as tacrolimus are commonly used to prevent transplant rejection but can be associated with kidney toxicity, hypertension, neurological side effects, and harm to insulin-producing islet cells, limiting their suitability for long-term use in patients with T1D receiving an islet cell transplant.

“T1D patients have been waiting decades for a potential functional cure, and it is exciting to see the progress being made in that direction through the emerging promise of tegoprubart,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “For people who have difficulty managing T1D, a regimen that may protect an islet cell graft without the long-term burden associated with calcineurin inhibitors, the current standard of care, could be transformational. We are proud to support this important research effort led by Dr. Witkowski and the team at UChicago Medicine. We also look forward to working closely with the FDA towards our goal of receiving regulatory guidance on a path to market for tegoprubart in islet cell transplantation later this year.”

“Insulin independence without the burden of traditional immunosuppression has long been one of cell replacement therapy’s biggest goals,” said Aaron Kowalski, Ph.D., Chief Executive Officer of Breakthrough T1D. “Results like these show that this goal is becoming increasingly achievable. Breakthrough T1D is proud to fund this important study.”

This UChicago Medicine-initiated clinical trial is funded by Breakthrough T1D, with initial support from The Cure Alliance. Breakthrough T1D has also committed to fund a second study evaluating tegoprubart as part of a calcineurin inhibitor-free immunosuppression drug regimen to prevent islet transplant rejection in individuals with T1D and chronic kidney disease.

About Islet Transplantation for Type 1 Diabetes

Pancreatic islet transplantation is a minimally invasive procedure developed to provide blood glucose control for subjects with type 1 diabetes and minimize or eliminate dependence on insulin. During the procedure, pancreatic islets containing insulin-producing beta cells are isolated from the pancreas of a deceased organ donor and infused through a small catheter into the patient’s liver. The islet cells lodge in small blood vessels in the liver and release insulin. After the procedure, subjects remain on immunosuppression therapy to prevent transplant rejection.

About Eledon Pharmaceuticals and tegoprubart

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

Follow Eledon Pharmaceuticals on social media: LinkedIn; X

Forward-Looking Statements

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

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

Release – Cocrystal Pharma Appoints James Sapirstein, Biopharma Industry Leader with Extensive Antiviral Development Experience, as Chief Executive Officer

Posted on by [email protected]

June 03, 2026

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BOTHELL, Wash., June 03, 2026 (GLOBE NEWSWIRE) — Cocrystal Pharma Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), a clinical-stage biotechnology company developing novel therapeutics to meet the growing need for effective, safe antiviral treatments, has appointed James Sapirstein Chief Executive Officer, effective immediately. The Company also plans to appoint Mr. Sapirstein as a member of the Board of Directors. He has extensive pharmaceutical industry leadership and development experience. Mr. Sapirstein replaces Sam Lee and Jim Martin, who served as Co-Chief Executive Officers. Sam Lee will continue as President and transition to Chief Scientific Officer, and Jim Martin will continue as Chief Financial Officer.

“James brings the right experience in the biopharma business as we’re accelerating the advancement of multiple clinical programs,” said Roger Kornberg, Ph.D., Chairman of Cocrystal Pharma. “We have known him for many years, and our management team and board are appreciative of his decision to join us as Chief Executive Officer.”

Mr. Sapirstein commented, “Cocrystal’s pipeline comprises transformative antivirals developed using its structure based drug discovery platform. We are well positioned with the right technology and team to create meaningful benefits for patients as well as our shareholders. The potential to address the need for new antivirals is highly motivating for me with my product development and launch background.”

Mr. Sapirstein has participated in or led 23 product launches. He has also driven numerous business development transactions. Mr. Sapirstein was Chief Executive Officer of Contravir Pharmaceuticals, served as the founding Chief Executive Officer of Tobira Therapeutics, and as Executive Vice President, Metabolic and Endocrinology, for Serono Laboratories.

Earlier in his career, he held senior marketing and commercialization positions, at Gilead Sciences and director of international marketing of the infectious disease division at Bristol Myers Squibb.

Mr. Sapirstein is a member of several industry boards and previously served as Chairman of BioNJ as well as Biotechnology Innovation Organization board member for more than a decade. He is also a founding member of the board of advisors of the Miami Biotech Collective.

About Cocrystal Pharma’s Structure-Based Drug Discovery Platform

Cocrystal Pharma is leveraging its structure based drug discovery platform technology to design next generation antiviral candidates that precisely target viral replication mechanisms. By binding to highly conserved regions of viral enzymes, the Company’s compounds aim to maintain potency against mutating strains while minimizing off target effects, offering potentially safer, broad spectrum antiviral solutions. This approach streamlines candidate identification and optimization, enabling more rapid progression of promising therapies with robust resistance and safety profiles.

The Company’s platform provides a three dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps identify novel binding sites and enables a rapid turnaround of structural information through highly automated X-ray data processing and refinement. This technology permits the development of novel broad spectrum antivirals.

About Cocrystal Pharma

Cocrystal Pharma Inc. is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2), and hepatitis C viruses. Cocrystal employs unique structure based technologies to create viable antiviral drugs. For more information, visit www.cocrystalpharma.com.

Release – Cadrenal Therapeutics to Showcase Phase 3-Ready CAD-1005 and Novel 12-LOX Platform at BIO International Convention 2026 Partnering Event

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PONTE VEDRA, Fla., June 03, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today announced its participation in the BIO International Convention 2026 Partnering Event (BIO 2026) taking place June 22-25, 2026, at the San Diego Convention Center.

The Company’s executive management team will host partnering meetings to discuss development and commercialization opportunities for its differentiated pipeline, headlined by CAD-1005, a Phase 3-ready 12-lipoxygenase (12-LOX) inhibitor being investigated for the treatment of patients with Heparin-Induced Thrombocytopenia (HIT), and tecarfarin, a late-stage oral Vitamin K antagonist (VKA) for being investigated for the treatment of patients with conditions for which current anticoagulation profiles are ineffective or suboptimal.

“BIO 2026 comes at a pivotal moment for Cadrenal as we prepare to initiate our Phase 3 registration trial for CAD-1005,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “With Orphan Drug and Fast Track designations from the FDA, we believe we are uniquely positioned to address the significant unmet need in HIT, a condition where no new therapies have been approved in over two decades. We look forward to engaging with potential partners who share our vision of the potential to bring this breakthrough mechanism to patients.”

Highlighting CAD-1005: A Potential First-in-Class Solution for HIT
At the forefront of Cadrenal’s portfolio is CAD-1005, the only selective 12-LOX inhibitor known to us to be currently in clinical development. CAD-1005 is being investigated to target the root cause of HIT-a severe, immune-mediated reaction to heparin that causes life-threatening blood clots and low platelet counts. Unlike current therapies that only reduce the risk of thrombotic complications, CAD-1005 is being investigated to interrupt the immune signaling feedback loop that drives the development and persistence of HIT.

The Company recently completed an End-of-Phase 2 (EOP2) meeting with the FDA, which provided guidance on the registration path for a single pivotal Phase 3 trial. This follows Phase 2 data demonstrating that CAD-1005 could reduce thrombotic events in patients with HIT.

Unlocking the Potential of the 12-LOX Platform
Beyond HIT, Cadrenal is leveraging the BIO 2026 partnering forum to explore broader applications for its proprietary 12-LOX inhibitor platform. Emerging research indicates that 12-LOX may play a central role in inflammatory signaling across high-impact disease areas, including atherosclerosis, microvascular thrombosis, and metabolic conditions such as diabetes and obesity. Additionally, 12-LOX is a potential target for therapy and prevention of cancer.

The Company’s platform represents a novel approach to modulating inflammation without the broader systemic suppression associated with traditional anti-inflammatory agents. Cadrenal aims to identify strategic collaborations to accelerate the development of its second-generation oral 12-LOX inhibitors (CAD-2000) for these chronic, large-market indications.

Tecarfarin: A Potentially Superior Anticoagulant for Complex Cases
Cadrenal will also present opportunities for tecarfarin, its late-stage oral anticoagulant. Tecarfarin is being designed with the goal of being uniquely metabolized in ways that avoid the drug-drug interactions and renal clearance issues common with warfarin and direct oral anticoagulants (DOACs). Tecarfarin has already received FDA Orphan Drug and Fast Track designations for two specific high-risk populations – patients with End-Stage Renal Disease (ESRD) and Atrial Fibrillation (AFib), and patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs).

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is being researched as a first-in-class 12-LOX inhibitor for treating heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also in development for chronic indications.

The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and those with left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor intended for use in acute hospital settings.

Release – MAIA Biotechnology Receives FDA Clearance to Open U.S. Enrollment in Ongoing Phase 2 THIO-101 Trial Expansion

Posted on by [email protected]

June 03, 2026 9:45am EDT

Additional data from THIO-101 trial expansion studies may further support a potential Accelerated Approval filing with FDA

FDA-cleared IND updates detail latest efficacy data and enriched manufacturing protocols

CHICAGO, June 03, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared an amendment to update its investigational new drug (IND) application which enables MAIA to open U.S. enrollment for the expansion of the Phase 2 THIO-101 trial of its lead candidate, ateganosine, as a treatment for advanced non-small cell lung cancer (NSCLC). Ateganosine is a novel dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. Ateganosine sequenced with a monoclonal antibody checkpoint inhibitor is being evaluated as a therapy for patients in ongoing Phase 2 and Phase 3 clinical trials.

MAIA obtained FDA clearance of its updated IND highlighting MAIA’s improved efficiencies to its manufacturing capabilities, including new manufacturers, formulation and storage conditions for ateganosine, and MAIA is now cleared to enroll patients in the U.S. for the expansion of the Phase 2 THIO-101 study of patients receiving advanced third-line (3L) NSCLC treatment. In addition to the U.S., the THIO-101 study is ongoing at 44 clinical sites in six countries. MAIA recently activated its first U.S. clinical site at Summit Medical Group in New Jersey.

In July 2025, the FDA granted Fast Track designation for ateganosine for the treatment of NSCLC. This designation allows for more frequent FDA communication, potential rolling review, and eligibility for Accelerated Approval and Priority Review. The additional data from the expansion studies may further support a filing for FDA Accelerated Approval.

“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two years for eight patients treated with ateganosine in Parts A and B of THIO-101. We believe this bodes well for Parts C and D evaluations which are specific to third-line treatment care only, where the unmet need for improved clinical outcomes is most urgent.”

K. Robinson Lewis, Senior Vice President and Head of Regulatory and Quality for MAIA, commented, “We are excited about the prospects for our U.S. trials following FDA clearance of our amended IND. The unmet need for effective third-line NSCLC treatments is widespread in the U.S. Based on strong clinical data documented so far, we are confident in the potential of our therapy to address this significant and substantially underserved patient population.”

In parallel with THIO-101, MAIA is actively screening and enrolling patients in a pivotal Phase 3 clinical trial, THIO-104, designed to assess overall survival for ateganosine sequenced with a CPI compared to investigator’s choice of chemotherapy in a 1:1 randomization of up to 300 third-line NSCLC patients.

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 THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

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.

MAIA Biotechnology (MAIA) – Phase 3 THIO-104 Trial Design Presented At ASCO

Posted on by [email protected]


Tuesday, June 02, 2026

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

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

Phase 3 THIO-104 Design Is Consistent With Expectations. MAIA presented a poster on May 31, 2026, at the Annual ASCO (American Society of Clinical Oncology) Meeting. The poster detailed the design of its ongoing Phase 3 THIO-104 trial that tests ateganosine (aka THIO) in combination with the checkpoint inhibitor cemiplimab as a third-line treatment for patients with non-small cell lung cancer (NSCLC) who have become resistant to CPI treatment and chemotherapy.

Trial Design Is Consistent With Results From Phase 2 THIO-101 Trial. The patient population, selected dose, and combination regimen with Ateganosine 180mg and cemiplimab (Libtayo, from Regeneron) are the same as those in the Phase 2 THIO-101 study. At last analysis as of June 30, 2025, this regimen showed a median observed Overall Survival (OS) of 17.8 months, compared with published studies reporting an OS of 5.8 months.


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Greenwich LifeSciences, Inc. (GLSI) – Additional Phase 3 FLAMINGO-01 Data Presented At ASCO Meeting

Posted on by [email protected]


Tuesday, June 02, 2026

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

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Additional Data Presented At ASCO. Greenwich LifeSciences presented an abstract and poster at the ASCO Annual Meeting.  The data assessed non-HLA-A*02 patients in the open-label arm after six monthly doses of GLA-100. The data show statistically significant injection site reaction (ISR) and immune response at baseline, with increases over time.

Patients Were Evaluated After Initial Immune Stimulation. Patients received the Primary Immunization Series (PIS), consisting of six vaccinations over the first six months of the trial. The fourth, fifth, and sixth vaccinations showed a significant increase in the percentage of patients showing an ISR compared to baseline. Of the 247 patients enrolled, 208 had both baseline vaccination and assessments at 4, 5, or 6 months.


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Tonix Pharmaceuticals Announces Publication of Phase 1 Clinical Data of TNX-1500, an Fc-Modified anti-CD40L (CD154) Monoclonal Antibody, in the Peer-Reviewed Journal of Clinical Immunology

Posted on by [email protected]
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May 27, 2026 7:00am EDT

Phase 1 data support TNX-1500 as a potentially first-in-class, best-in-class, third-generation anti-CD40L monoclonal antibody for the prevention of kidney transplant rejection

Phase 2 investigator-initiated study in adult kidney transplant at Massachusetts General Hospital (MGH) expected to initiate in the 2nd half of 2026 pending U.S. Food and Drug Administration (FDA) clearance of MGH’s Investigational New Drug (IND) application

BERKELEY HEIGHTS, N.J., May 27, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial-stage biotechnology company, today announced the publication of a paper, “First-in-Human, Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of TNX-1500, an Fc-Modified anti-CD154 Monoclonal Antibody, Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses in Healthy Adults,” in the peer-reviewed Journal of Clinical Immunology. TNX-1500 is an investigational, third-generation Fc-modified IgG4 anti-CD40L (also known as CD154) monoclonal antibody (mAb) in development for the prevention of organ transplant rejection and the treatment of autoimmune diseases. The manuscript can be accessed at https://pubmed.ncbi.nlm.nih.gov/42053701/.

“The CD40L is a validated target for preventing organ rejection in transplant and treating autoimmune disease, yet no anti-CD40L mAb has been approved for any indication,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-1500 is a Phase 2 ready humanized mAb engineered to improve safety and tolerability relative to first-generation anti-CD40L mAbs, while preserving the durable half-life and certain effector functions associated with the Fc or crystallizable fragment. We believe the Phase 1 results show that these design objectives were achieved in TNX-1500.”

Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals added, “The Phase 1 study evaluated TNX-1500’s safety, tolerability, pharmacokinetics, and pharmacodynamics. TNX-1500 was generally well tolerated, demonstrated a favorable safety profile, suppressed the primary and secondary T cell-dependent antibody responses (TDARs) to keyhole limpet hemocyanin (KLH) antigen, and showed a half-life which supports monthly intravenous dosing. We expect a Phase 2, investigator-initiated study of TNX-1500 in the prevention of kidney allograft rejection at MGH to begin in the 2nd half of 2026 pending clearance of the IND by the FDA.”

The publication reports findings from a single-center, first-in-human, Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose escalation study in 26 healthy adult volunteers. Participants were enrolled across three ascending dose cohorts (3, 10, and 30 mg/kg) or placebo and received a single intravenous infusion of TNX-1500 or placebo, followed by intramuscular injections of KLH on days 2 and 29 to assess the TDAR, and monitored over a 120-day follow-up period. TNX-1500 blocked the primary T cell–dependent antibody response to KLH at all doses, blocked the secondary response at the 10 and 30 mg/kg doses, and reduced peak secondary response to KLH by ~70% relative to placebo at the 3 mg/kg dose.

TNX-1500 was generally well tolerated, with no serious adverse events, and no discontinuations due to adverse events. The only treatment-emergent adverse event (TEAE) deemed possibly related to study drug was aphthous ulcer, which occurred in 1 participant in each of the three TNX-1500 groups; all TEAEs were rated as mild and resolved in 2-10 days. No TEAEs were determined to be related to KLH administration. There were no administration or injection site reactions (one of the prespecified TEAEs of special interest). Pharmacokinetic analyses suggested approximately dose-proportional exposure across the 3 to 30 mg/kg range, with mean terminal elimination half-lives of 37.8 and 33.8 days at the 10 and 30 mg/kg dose levels, respectively. TNX-1500 at 10 and 30 mg/kg blocked the primary and secondary anti-KLH TDAR through day 120, and at 3 mg/kg reduced the peak secondary response by approximately 70% relative to placebo. Across all dose cohorts, TNX-1500 was associated with a rapid (less than one-hour post-dose) and sustained reduction in soluble CD40L (sCD154) over the 120-day study period.

About TNX-1500

TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a Phase 2 ready, humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of kidney transplant rejection and the treatment of autoimmune diseases. Anti-CD40L has multiple potential indications in addition to solid organ and bone marrow transplantation including autoimmune diseases. Collaborations are ongoing with MGH on allo-heart and -kidney transplantation in nonhuman primates, as well as prevention of xenograft rejection, preclinical studies, and prevention of allograft rejection in sensitized patients. The Phase 2 investigator-initiated study by MGH is expected to initiate enrollment in the 2nd half of 2026, pending FDA clearance of the IND, to evaluate TNX-1500 in five kidney transplant recipients. The study is designed to assess the safety, tolerability, and activity of TNX-1500 in preventing kidney transplant rejection while decreasing the exposure to conventional immunosuppressive drugs, which are associated with infection, cancer, cardiovascular side effects, and various metabolic derangements with long term use.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is extending the science behind TONMYA in Phase 2 clinical studies to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S. and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and smallpox. Within immunology, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome. To learn more, visit www.tonixpharma.com.

*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA® and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts

Jessica Morris
Tonix Pharmaceuticals
(862) 799-8599
[email protected]

Brian Korb
astr partners
(917) 653-5122
[email protected]

Media Contacts

Deborah Elson
Tonix Pharmaceuticals
[email protected]

Ray Jordan
Putnam Insights
[email protected]

Source: Tonix Pharmaceuticals Holding Corp.

GeoVax Labs (GOVX) – Development To Focus On Best Opportunities In Infectious Disease and Oncology

Posted on by [email protected]


Wednesday, May 27, 2026

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

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Resources To Focus On Current Market Needs. GeoVax has reviewed its pipeline products in infectious disease and oncology programs. Preparations will continue for the Phase 3 immunobridging trial in Mpox, expected to begin later this year.  A Phase 2 for Gedeptin is planned for FY2027. Development of CM-04S1 has been terminated, as the diminished need for a vaccine to protect immunocompromised patients from COVID-19 no longer justifies its continuation.

GEO-MVA and Infectious Diseases Remain A Priority. As discussed in our Research Note on May 19, 2026, GeoVax is preparing for a Phase 3 immunobridging trial in Mpox that could meet EMA requirements for accelerated approval. The trial is expected to begin in 2H26 with a planned enrollment of about 500 participants. The preclinical pipeline includes products for other infectious viruses that could be developed if grant or other funding were available.


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Cocrystal Pharma (COCP) – Technology Platform Has Novel Therapeutics Against Hantavirus, Bunyavirus, and Influenza

Posted on by [email protected]


Wednesday, May 27, 2026

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

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Proprietary Technology Has Produced A Large Library Of Novel Antivirals. Cocrystal has developed a library of antivirals based on its proprietary technology. While clinical development has prioritized products with clear medical needs and regulatory pathways to approval, it continues to research new compounds that can be moved into development as public health needs change. After the recent outbreaks of hantavirus, Ebola, and several previously lesser-known viruses, the company tested some of these compounds and found them to be effective.

Cocrystal’s Proprietary Technology Acts Early In The Viral Lifecycle. Cocrystal drugs target enzymes essential to the viral life cycle and reproductive process. These enzymes are highly conserved across viral families and rarely mutate, allowing compounds to show broad efficacy against multiple strains. This differs from vaccines that train the immune system to recognize and kill a virus. Vaccines often target surface proteins that can mutate, rendering the vaccine ineffective.


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GeoVax Labs (GOVX) – Recent Events Put GeoVax Programs For Mpox, Ebola, and Infectious Disease Programs In The Spotlight

Posted on by [email protected]


Tuesday, May 19, 2026

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

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WHO Has Declared Ebola A Public Health Emergency. On Sunday, May 17, the World Health Organization (WHO) declared Ebola a Public Health Emergency of International Concern (PHEIC), the highest level of global health alert it can issue. We believe the World Health Assembly in Geneva, Switzerland, held from May 18 to May 23, is increasing attention to outbreaks of Mpox, Ebola, and other infectious diseases. GeoVax is one of the few companies that has developed vaccines against these diseases.

GeoVax Has Overlooked Programs For Additional Infectious Diseases. GeoVax has completed pre-clinical work testing vaccines for hemorrhagic fever viruses, including Ebola, Sudan, and Marburg. It has developed these vaccines in collaborations with the National Institutes of Health, but has focused its resources on GEO-MVA, CM-04S1, and Gedeptin. The increased attention to Ebola could help obtain non-dilutive funding for these programs.


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Eledon Pharmaceuticals (ELDN) – Eledon Confirms Clinical Milestones With 1Q26 Report

Posted on by [email protected]


Monday, May 18, 2026

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

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1Q26 Report Included Milestones For FY2026. Eledon reported a Loss From Operations of $21.2 million, before interest income and a non-cash charge of $19.0 million from Changes in the Fair Value of Warrant Liabilities. This brought the 1Q26 Net Loss to $39.0 million or $(0.33) per share. The quarterly report confirmed our expectations for progress toward a Phase 3 trial in renal transplantation, as well as additional clinical trials in other organ transplants. Cash on March 31, 2026, was $111.1 million.

Several Clinical Milestones Are Expected For Renal Transplantation. We expect continued discussions with the FDA on the Phase 3 trial design and approval requirements. As discussed in our Research Note on February 2, additional long-term data from the Phase 1b trial were presented, with additional presentations of Phases 1b and 2 BESTOW extension data planned. We expect these studies to further support its safety profile and kidney function benefits.


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