Category: Health

Release – NeuroSense Reports Positive Biomarker Findings from Phase 2 RoAD Proof-of-Concept Study of PrimeC in Alzheimer’s Disease

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Research News and Market Data on NRSN

PrimeC was associated with changes across multiple biomarkers spanning key neurodegenerative disease pathways, providing early biological evidence consistent with potential target engagement

Findings support continued development of PrimeC’s multi-target approach in Alzheimer’s disease

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CAMBRIDGE, Mass., June 25, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced positive biomarker findings from its Phase 2, randomized, double-blind, placebo-controlled proof-of-concept RoAD study (NST-AD-001) of PrimeC in Alzheimer’s disease (AD).

The RoAD clinical trial enrolled eight participants, randomized to PrimeC or placebo. Three participants completed a 12-month follow-up period, with both CSF and plasma samples collected at three timepoints.

The plasma biomarker analysis showed multiple, distinctive protein biomarker changes. Most notably, these included changes in the hallmark protein biomarkers of AD – brain-derived tau (total) and phospho-tau(s) as well as the amyloid-beta 42/40 ratio. Distinctive changes were also found in the levels of other major neurodegenerative disease misfolding proteins: alpha-synuclein (total, oligomeric and p129) and TAR DNA-binding protein 43 (“TDP-43,” both total and p409). TDP-43 is the hallmark of ALS while Parkinson’s and dementia with Lewy bodies are characterized by accumulations of alpha-synuclein. These pathological proteins commonly co-occur with Alzheimer’s disease. Either (or both) of these may be present in more than 50% of Alzheimer’s disease cases, and when co-pathology is present, it is associated with faster and/or more severe dementia. Finally, additional changes were observed in key biomarkers of oxidative stress and inflammation affecting proteostasis and neurodegeneration. All of these changes were directionally consistent with PrimeC’s proposed mechanism of action and align with biomarker effects previously observed in the Company’s ALS program, supporting engagement of shared neurodegenerative pathways.

The biomarker findings supporting PrimeC’s target engagement build on its previously reported favorable safety and tolerability profile from RoAD, in which no serious adverse events and no new or unexpected safety signals were identified.

“The initial findings seen from the RoAD study are encouraging, in that they may suggest that the same multi-target mechanism we have been advancing in ALS is engaging biology that is also central to Alzheimer’s,” said Alon Ben-Noon, Co-Founder and Chief Executive Officer of NeuroSense. “This was a small, exploratory proof-of-concept study with a limited number of analyzable patient samples, and so we are appropriately measured about what it can tell us on its own. But seeing biological signals that point in the same direction across two distinct neurodegenerative diseases strengthens our conviction in PrimeC’s underlying approach and helps inform the design of a next, adequately powered study.”

“Alzheimer’s disease is driven by multiple, interacting pathological processes, which is one reason single-target therapies so often fall short. The biomarker findings in this first treated AD patient suggest broad proteostatic effects, consistent with PrimeC’s proposed mechanism of action,” said Prof. Steven E. Arnold, Professor of Neurology at Harvard Medical School and member of NeuroSense’s Scientific Advisory Board. “Of course these are the very first biomarker data of PrimeC treatment in AD and should be interpreted with that in mind. They do, however, support the rationale for evaluating PrimeC in a larger, well-controlled trial designed to test whether these biological effects replicate and more importantly, translate into meaningful clinical benefit.”

Next Steps

NeuroSense intends to use these proof-of-concept findings to help inform the design of a future, adequately powered clinical study of PrimeC in Alzheimer’s disease, and will continue engaging with scientific and regulatory stakeholders as the program advances.

About RoAD

RoAD (NST-AD-001) is a Phase 2, randomized, double-blind, placebo-controlled, exploratory proof-of-concept study evaluating the safety, tolerability, and biomarker effects of PrimeC in eight participants with Alzheimer’s disease. As a proof-of-concept study, clinical outcome measures are descriptive by design.

About Alzheimer’s Disease

Alzheimer’s disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia worldwide, affecting more than 30 million people globally. AD is characterized by memory loss, cognitive decline, and behavioral changes, and currently has no cure. Existing therapies provide only limited symptomatic relief, leaving a significant unmet need for disease-modifying treatments that can slow or halt progression. Given the complexity of AD, approaches that target multiple disease mechanisms simultaneously, such as PrimeC, hold potential to deliver meaningful therapeutic advances for patients and their families.

About PrimeC

PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.

About NeuroSense

NeuroSense Therapeutics, Ltd. is a late-stage clinical biotechnology company focused on discovering and developing treatments for people suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements, including, without limitation, statements regarding the interpretation, significance and potential implications of the exploratory biomarker observations from the RoAD study, the potential of PrimeC to affect disease related biology or engage mechanisms relevant to Alzheimer’s disease and the potential for these preliminary observations to inform the design of future studies. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include, without limitation, the very limited sample size and exploratory nature of the biomarker analyses reported in this press release; the risk that preliminary observations from three analyzed patients may not be predictive, may not be statistically meaningful, may not be replicated in this study or future studies and may not correlate with or translate into clinical outcomes or benefit or disease modification; risks related to the timing of current and future clinical trials; the risk that PrimeC will not advance towards later-stage development; the risk that additional data from the RoAD study may differ from the observations reported in this press release; timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

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SOURCE NeuroSense

For further information: For further information: Email: [email protected] | Tel: +972 (0)9 799 6183

Release – MAIA Biotechnology Completes International Enrollment in Part C of Phase 2 THIO-101 Expansion Trial in Third-Line Non-Small Cell Lung Cancer

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Research News and Market Data on MAIA

June 25, 2026 8:08am EDTDownload as PDF

Part C domestic enrollment is underway at three clinical sites in the U.S.

CHICAGO, June 25, 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 completed international enrollment in Part C of its Phase 2 THIO-101 expansion trial evaluating its lead candidate, ateganosine, in advanced non-small cell lung cancer (NSCLC) patients receiving third line (3L) therapy. Ateganosine is an investigational dual-mechanism therapy targeting telomeres and immune activation in difficult-to-treat cancers.

THIO-101 Part C patients, who are resistant to prior checkpoint inhibitor (CPI) therapy and chemotherapy, are randomized between MAIA’s proposed combination regimen of ateganosine followed by cemiplimab (Libtayo®) and treatment with ateganosine alone for two cycles. International screening was conducted in Taiwan, Turkey, Poland, Hungary, Romania and Georgia, with 41 patients enrolled and receiving treatment. The Part C study is currently screening patients at multiple clinical sites in the United States.

“We greatly appreciate the dedication and contributions of the investigators supporting our THIO-101 trial,” said Vlad Vitoc, Founder and Chief Executive Officer of MAIA Biotechnology. “With enrollment now complete at the international Part C clinical sites, we are closely monitoring patient outcomes as the data continues to mature, including key efficacy measures such as disease control rate and overall survival, which have remained central endpoints throughout the Phase 2 THIO-101 trial. Meanwhile, patient screening is ongoing at three activated clinical sites in the United States.”

In Parts A and B of THIO-101, MAIA reported data showing median survival of 17.8 months. Overall survival (OS) beyond two years was observed for eight patients in Parts A and B of THIO-101; the patients did not receive subsequent lines of therapy. One patient in this cohort receiving 3L therapy has survived for over 33 months. Expected survival in this heavily pre-treated population is 5.8 months.1

The FDA has granted Fast Track designation for ateganosine in NSCLC treatment, potentially expediting the regulatory process to a potential Accelerated Approval and Priority Review.

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
+1 (872) 270-3518
[email protected]

1 Girard N, et al. J Thorac Onc 2009;12:1544-1549

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Source: MAIA Biotechnology, Inc.

Released June 25, 2026

NeuroSense Therapeutics Ltd. (NRSN) – Phase 2 RoAD Trial Findings In Alzheimer’s Disease Reported

Posted on by [email protected]


Thursday, June 25, 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.

New Data Supports Mechanism of Action. NeuroSense reported data from its Phase 2 RoAD trial testing PrimeC in Alzheimer’s Disease (AD). The study was designed to evaluate safety, efficacy, and disease-associated biomarkers. The results showed changes consistent with the prevention of degeneration and neuronal cell death. We believe these data support PrimeC’s mechanism and its benefits, providing proof of concept for further studies.

Study Design. The Phase 2 RoAD trial was a placebo-controlled study testing PrimeC in Alzheimer’s disease. The trial enrolled eight patients who were randomized to receive PrimeC or placebo for 52 weeks. Three participants completed a 12-month follow-up period, with CSF and plasma samples evaluated at three timepoints.


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Release – Cadrenal Therapeutics Announces Selection of CAD-1005 Phase 2 Study for Late-Breaking Oral Presentation at ISTH 2026 Congress

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Research News and Market Data on CVKD

Selection highlights the clinical value potential of Cadrenal’s first-in-class 12-lipoxygenase inhibitor for Heparin-Induced Thrombocytopenia (HIT)

First-ever randomized, blinded, placebo-controlled trial in HIT, a life-threatening blood-clotting disorder triggered by an immune reaction to heparin, the most widely used blood thinner in hospitals

Phase-3 ready and addresses a peak $2 billion annual revenue potential in the HIT market

PONTE VEDRA, Fla., June 24, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company advancing late-stage novel therapies for life-threatening immune and thrombotic conditions, today announced that late-breaking clinical data on its first-in-class 12-lipoxygenase (12-LOX) inhibitor, CAD-1005 (formerly VLX-1005), have been accepted for a prestigious oral presentation at the 34th Congress of the International Society on Thrombosis and Haemostasis (ISTH). The congress will be held live and onsite from July 11-15, 2026, at the Palais des Congrès de Paris in Paris, France.

The abstract, titled “12-lipoxygenase inhibition with VLX-1005 in heparin-induced thrombocytopenia,” was selected by expert peer reviewers for inclusion in the high-profile session on clinical trials and breakthrough innovations.

“The selection of our Phase 2 CAD-1005 study for a late-breakthrough oral presentation at ISTH is another milestone underscoring the scientific integrity and commercial importance of our pipeline,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “Heparin-Induced Thrombocytopenia represents a high-value therapeutic market with significant unmet needs and no approved therapies that target the specific underlying immune mechanisms of HIT. This presentation offers an elite global platform to showcase the clinical potential of CAD-1005.”

“Targeting 12-lipoxygenase is a novel, highly selective therapeutic approach that addresses the root cause of immune-mediated platelet activation in HIT,” added Dr. Steve McKenzie, Professor of Medicine at Thomas Jefferson University, the principal investigator and presenter. “The data we are presenting live in Paris – the first-ever randomized, blinded, placebo-controlled trial in HIT – illustrate how CAD-1005 could fundamentally shift the treatment paradigm for acute thrombotic care and may, if approved, offer a highly differentiated option for these high-risk patients.”

Presentation Details:

  • Session Title: Late-Breakthrough Abstracts I: Clinical Trials and Innovation in Thrombosis
  • Abstract Title: 12-lipoxygenase inhibition with VLX-1005 in heparin-induced thrombocytopenia
  • Date: July 12, 2026
  • Session Time: 11:15 AM – 12:00 PM CEST

For additional details regarding the scientific program, please visit the ISTH Congress Official Website.

About Heparin-Induced Thrombocytopenia (HIT)

HIT is an immune-mediated, prothrombotic adverse drug reaction in which antibodies against platelet factor 4-heparin complexes activate platelets via FcγRIIA receptors, triggering a cascade that can lead to life-threatening thrombosis. Current management relies on non-heparin anticoagulants, which reduce thrombin generation but do not directly address the underlying antibody-mediated platelet activation; new thrombosis remains a major clinical concern even with appropriate anticoagulant therapy.

About CAD-1005

CAD-1005 is a novel investigational therapeutic under development for the treatment of heparin-induced thrombocytopenia (HIT). CAD-1005 is designed to selectively inhibit 12-lipoxygenase (12-LOX), an enzyme central to platelet immune activation and thrombo-inflammatory signaling associated with HIT. CAD-1005 is intended to be used alongside existing standards of care and is being developed to address the underlying biological mechanisms that contribute to disease progression.

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 investigated as a first-in-class 12-LOX inhibitor for 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 and 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, those with left ventricular assist devices, and potentially, those with Kawasaki disease (KD), an acute self-limited febrile illness that primarily affects children <5 years old, and the leading cause of acquired heart disease in developed countries.

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, without limitation, statements regarding the late-breakthrough oral presentation at ISTH being a significant milestone that supports the scientific integrity and commercial importance of the Company’s pipeline and the data being presented illustrating how CAD-1005 could fundamentally shift the treatment paradigm for acute thrombotic care, and may, if approved, offer a highly differentiated option for these high-risk patient patients and CAD-1005 being intended to be used in conjunction with existing standards of care and is being developed to address the underlying biological mechanisms contributing to disease progression.

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to raise sufficient capital to continue progress of CAD-1005; the ability to advance directly to Phase 3 study evaluating CAD-1005 in patients with HIT; the ability to successfully design and complete the Phase 3 study and derive the results needed for an NDA submission; and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, 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.

For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

For more information, please contact:

Lytham Partners, LLC, Robert Blum, Managing Partner, 602-889-9700, [email protected]

Boundless Bio Pivots From Cancer to a Rare Genetic Disease in a Reverse Merger With Serapha Bio

Posted on by [email protected]

In a transaction that illustrates how struggling clinical-stage biotechs are increasingly being repurposed as vehicles for more promising assets, Boundless Bio (Nasdaq: BOLD) announced Tuesday it has entered into a definitive all-stock merger agreement with privately held Serapha Bio. The deal will see Serapha combine with Boundless Bio and effectively take over the public company, pivoting the combined entity away from Boundless’s cancer research and toward Serapha’s gene editing therapy for a serious inherited disease. Boundless Bio shares surged approximately 75% on the news to around $2.50.

Upon completion, the combined company will operate under the name Serapha Bio and is expected to trade on Nasdaq under the new ticker symbol “AATD” — a direct reference to the disease its lead program targets.

The Structure of the Deal

This is a reverse merger, a structure in which a private company merges into a public one to gain a stock market listing without conducting a traditional IPO. The ownership split makes the dynamic clear: pre-merger Boundless Bio stockholders are expected to own approximately 3.7% of the combined company, while pre-merger Serapha stockholders — including investors participating in the concurrent financing — will own approximately 96.3%.

Two features make this transaction particularly notable for shareholders. First, alongside the merger, Serapha is raising $230 million in a concurrent private placement co-led by RTW Investments and RA Capital Management, with participation from a syndicate of top healthcare investors and mutual funds. That level of institutional backing provides the combined company with substantial capital to advance its lead program through clinical development. Second, prior to closing, Boundless Bio expects to declare a cash dividend to its pre-merger stockholders to distribute excess net cash, currently estimated at approximately $44 million to $48 million. That dividend, combined with the stock’s jump, gives existing Boundless holders both an immediate cash return and continued exposure to the new program.

What Serapha Is Actually Developing

Serapha’s lead program, SERP-01, is an investigational in vivo base editing therapy targeting Alpha-1 Antitrypsin Deficiency, a serious inherited genetic disorder that can cause progressive lung and liver disease. The therapy specifically targets the SERPINA1 E342K mutation — known as the PiZZ genotype — which is the most common cause of severe AATD. The company has reported proof-of-concept data demonstrating restoration of serum AAT to normal levels, an encouraging early signal for a disease that currently has limited treatment options.

The asset has an international development backstory. Serapha licensed SERP-01, developed as YOLT-202 in Greater China, from YolTech Therapeutics in June 2026 in exchange for an upfront cash payment and a minority equity stake. Under the agreement, YolTech is eligible to receive regulatory and commercial milestones totaling over $2 billion plus tiered royalties, while retaining development and commercialization rights for the Greater China territory. YolTech has been enrolling AATD patients in an investigator-initiated trial at Renji Hospital in Shanghai.

The Small Cap Biotech Read

For investors tracking the small and microcap biotech space, this transaction reflects a pattern that has become increasingly common in 2026. Clinical-stage companies whose original programs have stalled or been deprioritized are valuable to private biotechs precisely because of what they already possess: a Nasdaq listing, a cash balance, and an existing shareholder base. Rather than navigate the lengthy and uncertain IPO process, a promising private company like Serapha can access public markets, raise institutional capital, and advance its lead asset all in a single coordinated transaction.

The base editing space in particular has attracted significant investor attention as next-generation gene editing technologies move from theoretical promise toward clinical proof of concept. With $230 million in fresh capital, validated early data, and a clear regulatory target in a serious genetic disease, the newly formed Serapha Bio enters the public market positioned to advance one of the more closely watched programs in the in vivo base editing field. The transaction is expected to close in the fourth quarter of 2026, subject to stockholder approval and customary closing conditions.

Eledon Pharmaceuticals (ELDN) – Eledon Presents Data Update From Phase 2 Trial With Clinical Trial Plans

Posted on by [email protected]


Tuesday, June 23, 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.

Long-Term Outcomes Favor Tegoprubart. Eledon presented long-term data from its Phase 2 BESTOW trial at the American Transplantation Congress (ATC). The BESTOW trial tested tegoprubart as part of the immunosuppressive regimen for patients receiving kidney transplants. Data from the Open Label Extension study showed consistent improvements in kidney function and a reduction in rejection episodes. Importantly, the side effect profile continues to show significant  improvements over tacrolimus, the standard of care.

Trial Background. The Phase 2 BESTOW trial was a double-blind study testing tegoprubart as an immunosuppressive after kidney transplantation. An active comparator arm included tacrolimus as an immunosuppressive. The primary endpoint of the trial was eGFR (estimated Glomerular Filtration Rate) and BPAR (Biopsy Proven Acute Rejection) episodes. Following the completion of the 12-month course of treatment, patients were given the option to continue in an Open Label Extension (OLE) study.


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Release – EverythingALS to Host NeuroSense in a Community Event Named: PrimeC – Connecting the Dots

Posted on by [email protected]

Research News and Market Data on NRSN

CAMBRIDGE, Mass., June 22, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced that EverythingALS will host a conversation built around a look at emerging data on PrimeC and what it may mean for the science of ALS and the people living with it.

Event details:

Date: June 24, 2026
Time: 7 pm ET
Link for registration: Click Here

The session will be presented by Prof. Jeffrey Rosenfeld, MD, PhD, FAAN, Professor of Neurology and Director of the Neuromuscular ALS/MND Program at Loma Linda University School of Medicine. With more than 30 years caring for people with ALS and leading some of the most extensive multidisciplinary ALS programs in the country, Prof. Rosenfeld brings both the clinical depth and the bedside perspective to walk through what the latest findings show.

He’ll be joined by Alon Ben-Noon, Co-Founder and CEO of NeuroSense Therapeutics, for the conversation that follows.

This is a conversation for people living with ALS, families, caregivers, clinicians, and anyone who wants to understand the latest developments in ALS research.

About NeuroSense

NeuroSense Therapeutics is a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease. The Company’s lead product candidate, PrimeC, is a novel oral therapy designed to target multiple key biological pathways underlying disease progression, including neuroinflammation, oxidative stress and dysregulated iron metabolism.

NeuroSense has generated compelling clinical data from its Phase 2b PARADIGM study in ALS, demonstrating meaningful slowing of disease progression. The Company also reported significant biological activity across multiple biomarkers associated with ALS, including microRNAs, supporting PrimeC’s multi-target mechanism of action. Notably, long-term follow-up data indicated a meaningful survival benefit, representing a potentially important advancement in the treatment of ALS.

NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a pivotal Phase 3 clinical trial (PARAGON) in ALS, which is expected to enroll approximately 300 participants, primarily in the United States.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

About PrimeC

PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements, including statements regarding the planned event, development, regulatory progress and potential commercialization of PrimeC, are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the uncertainty regarding the benefits of outcomes and the timing of current and future clinical trials; timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2026 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

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SOURCE NeuroSense

For further information: For further information: Email: [email protected] | Tel: +972 (0)9 799 6183

Release – Eledon Presents Long-Term Extension Phase 2 BESTOW Results at American Transplant Congress Showing Sustained Higher Kidney Function and Improved Patient-Reported Outcomes with Tegoprubart Compared with Tacrolimus

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Research News and Market Data on ELDN

June 22, 2026

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Tegoprubart-treated patients maintained higher mean eGFR over time, including a statistically significant approximately 12 mL/min/1.73 m² advantage at month 18 versus tacrolimus (74 vs. 61 mL/min/1.73 m²; p<0.05)

No biopsy-proven acute rejection (BPAR) events were observed in tegoprubart-treated patients after the first six months post-transplant, compared with seven BPAR events (9.4% of tacrolimus-treated patients) reported in the tacrolimus arm

Patient-reported outcomes at 52 weeks favored tegoprubart, with statistically significant improvements versus tacrolimus on two validated measures of symptom burden

Conference call and webcast to be held today at 8:00 a.m. ET

IRVINE, Calif., June 22, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced new long-term data from its Phase 2 BESTOW clinical program evaluating tegoprubart in patients undergoing kidney transplantation, presented in oral and poster presentations at the American Transplant Congress (ATC) taking place June 20-24, 2026, in Boston, Massachusetts. The presentations highlight updated results from the Phase 2 BESTOW trial and new long-term follow-up data from the Phase 2 BESTOW extension study.

“These long-term data further strengthen our belief that tegoprubart has the potential to redefine the standard of care in transplant immunomodulation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “A statistically significant kidney function benefit at 18 months, no observed BPAR events after six months in tegoprubart-treated patients, favorable long-term safety and tolerability, and improved patient-reported outcomes collectively reinforce tegoprubart’s emerging, differentiated clinical profile as we prepare to advance into Phase 3 development.”

“For kidney transplant recipients, success is measured not only by preventing rejection, but by preserving kidney function and maintaining quality of life over the long term,” said Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief, Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota. “These data are especially encouraging because tegoprubart was associated with sustained kidney function and improvements in patient-reported measures of symptom burden compared with tacrolimus. Providing an effective alternative to tacrolimus-based immunosuppression remains one of the most important unmet needs in kidney transplantation, particularly because lifelong immunosuppression can affect both long-term graft survival and how patients feel and function every day.”

Efficacy Results

  • Among patients who completed 12 months of treatment in the BESTOW study, 96% (49/51) of tegoprubart-treated patients and 86% (48/56) of tacrolimus-treated patients entered the BESTOW long-term extension study. As of the data cutoff, mean follow-up was 21 months, with: 89 patients followed through 18 months, 20 patients followed through 24 months, and the longest-followed ongoing patient followed for approximately 33 months.
  • Kidney graft function, as assessed by estimated glomerular filtration rate (eGFR), stabilized after the first month of treatment and remained higher in tegoprubart-treated patients than in tacrolimus-treated patients at each reported time point. At month 18, tegoprubart-treated patients demonstrated a statistically significant approximately 12 mL/min/1.73 m² higher mean eGFR compared with tacrolimus-treated patients (74 vs. 61 mL/min/1.73 m²; p<0.05).
  • No biopsy-proven acute rejection (BPAR) events were observed in tegoprubart-treated patients after the first six months of treatment. In the tacrolimus arm, seven of 11 total BPAR events (approximately 64% of BPAR events) occurred after six months, including two events after 12 months: one new case of active antibody-mediated rejection (aAMR) and one recurrent case of active T-cell-mediated rejection with aAMR.
  • Patient-reported outcome measures demonstrated lower symptom burden among tegoprubart-treated patients compared with tacrolimus-treated patients at 52 weeks, with statistically significant improvements on the Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R; treatment difference: -12.2; 95% CI: -19.7, -4.6; p<0.05) and the KDQOL-36 Symptoms and Problems domain (treatment difference: 5.7; 95% CI: 1.0, 10.5; p<0.05).
  • In an exploratory analysis of patients who experienced rejection post-transplant, those who remained on tegoprubart maintained higher mean eGFR than tacrolimus-treated patients who experienced rejection, with the observed difference increasing from approximately 15 mL/min/1.73 m² at 12 months to approximately 25 mL/min/1.73 m² at 21 months.
  • Long-term follow-up from the Phase 1b study for patients treated at the 20 mg/kg dose of tegoprubart was consistent with the Phase 2 BESTOW results, with no BPAR episodes observed after six months in tegoprubart-treated patients. In the Phase 1b study, long-term data was available for 16 patients; eight patients have been followed through 24 months, and the longest-followed ongoing patient has been on tegoprubart for approximately 3.5 years.

Safety Results

  • In the BESTOW long-term extension study, key central nervous system and kidney-related adverse events were observed more frequently in the tacrolimus arm than in the tegoprubart arm, including headache (12% vs. 2%), extremity pain (10% vs. 0%), fall or loss of balance (6% vs. 0%), and acute kidney injury (6% vs. 2%), respectively.
  • Diarrhea was observed more frequently in the tacrolimus arm than in the tegoprubart arm during long-term follow-up (21% vs. 10%, respectively). This pattern was consistent with the first-year BESTOW results, in which diarrhea was reported in 34% of tacrolimus-treated patients vs. in 22% of tegoprubart-treated patients.
  • No graft loss, no progressive multifocal leukoencephalopathy (PML), no post-transplant lymphoproliferative disorder (PTLD), no BK or CMV nephropathy/disease, and no new malignancies were reported in the BESTOW long-term extension study. No new proteinuria was reported on the tegoprubart arm. One death occurred in the tegoprubart arm and was not attributed to study drug.

Next Steps

Following a successful FDA End-of-Phase 2 meeting, Eledon has established the regulatory framework for its Phase 3 kidney transplantation program and plans to initiate Phase 3 clinical development of tegoprubart in late 2026. The Phase 3 primary endpoint is expected to be non-inferiority versus tacrolimus at 52 weeks on a composite of BPAR, graft loss and death. The Phase 3 study will also incorporate key learnings from the Phase 2 BESTOW trial and ongoing long-term extension study, including evidence of sustained kidney function benefit, favorable rejection outcomes, and improved patient-reported outcomes.

Investor Conference Call Information

Eledon will hold a conference call today, June 22, 2026 at 8:00 a.m. Eastern Time to discuss the long-term data from the Phase 2 BESTOW and the Phase 1b kidney transplant clinical trials, as well as to discuss recently presented data from the on-going islet cell transplant investigator sponsored study. The dial-in numbers are 1-800-717-1738 for domestic callers and 1-646-307-1865 for international callers. The conference ID is 84665. A live webcast of the conference call will be available on the Investor Relations section of the Company’s website at www.eledon.com. The webcast will be archived on the website following the completion of the call.

Full details of the ATC oral presentation are below:

Title: Phase 2 BESTOW Trial: Evaluating Tegoprubart’s Safety and Efficacy in Preventing Kidney Transplant Rejection
Presenter: Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief, Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota; Executive Medical Director, Solid Organ Transplant Service Line, M Health Fairview
Abstract Publication Number: 585
Session Title: Emerging Discoveries Oral Abstract Session – Kidney: Biomarkers -3
Session Date and Time: Monday, June 22, 2026, from 11:15 a.m. – 12:15 p.m. ET
Session Room: 253BC (Level 2)
Presentation Time: 12:03 p.m. – 12:15 p.m. ET

About Eledon Pharmaceuticals and tegoprubart

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

Follow Eledon Pharmaceuticals on social media: LinkedIn; X

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: our short operating history and shifts in our business strategy; our operating losses since inception; our need for additional funding to develop our lead drug candidate and our ability to secure additional funding on acceptable terms or at all; the impact of issuances of our common stock, including in the possibility of dilution or a decline in our stock price; our ability to successfully develop our product candidates; unfavorable global economic and financial market conditions; the regulatory environment of our business and our ability to obtain required regulatory approvals; results of non-clinical studies and clinical trials, and risks that non-clinical studies or early clinical trials may not be predictive of results of later-stage clinical trials; delays or difficulties in enrollment of patients in clinical trials; our ability to attract and retain our executives and key employees; legislation of the pharmaceutical and healthcare industries; cybersecurity and data privacy risks; the ability of our products to achieve marketing approval; competition in our industry; our ability to obtain insurance coverage; our dependence on contract research organizations; our ability to protect our intellectual property; public health crises; our ability to maintain proper and effective internal control over financial reporting and other risks disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 19, 2026. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ materially from the forward-looking statements contained herein, are discussed in our Annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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

MAIA Biotechnology (MAIA) – Stream Of Clinical Milestones Reported In June Shows Ateganosine Progress

Posted on by [email protected]


Monday, June 22, 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.

Strong Progress Reported In Both Clinical Trials. MAIA currently has two clinical trials in progress. Both trials are testing the combination of ateganosine (aka THIO) and the checkpoint inhibitor cemiplimab (Libtayo, from Regeneron) as a third-line treatment for advanced non-small cell lung cancer (NSCLC). During June, MAIA opened two additional clinical sites for Phase 2 and reported strong enrollment progress in Phase 3.

Initial Phase 3 Enrollment Rate Has Been Strong. The Phase 3 THIO-104 trial began treating patients in early December. Within six months, the company opened 34 clinical sites and began treating 29 patients across 6 countries (select European countries, Turkey, Taiwan, and Georgia). THIO-104 has a target enrollment of 300 patients that will be randomized 1:1 to receive either the combination regimen or “investigator’s choice” of standard chemotherapies.


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Release – Cadrenal Therapeutics to File for FDA Rare Pediatric Disease Designation for Tecarfarin in Kawasaki Disease

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Research News and Market Data on CVKD

Company to present Phase 3-ready pipeline, 12-LOX platform, and pediatric rare-disease expansion to global pharmaceutical partners at the 2026 BIO International Convention in San Diego

Kawasaki disease is the leading cause of acquired heart disease in children in developed nations. Patients are at risk of forming blood clots in coronary arteries and may require lifelong treatment

If the designation is granted and tecarfarin is approved for this indication, Cadrenal would be eligible to receive a Priority Review Voucher-recent open-market valuations for these vouchers have reached into the ~$200 million range

PONTE VEDRA, Fla., June 18, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company advancing late-stage novel therapies for life-threatening immune and thrombotic conditions, today announced plans to submit a Rare Pediatric Disease Designation (RPDD) request to the U.S. Food and Drug Administration (FDA) for tecarfarin as a treatment for pediatric patients with Kawasaki disease (KD) who develop coronary artery aneurysms (CAAs) and require chronic oral anticoagulation.

The announcement comes ahead of the BIO International Convention, June 22-25, 2026, in San Diego, California. Cardenal’s executive leadership team will highlight this rare pediatric initiative and its Phase 3-ready CAD-1005 platform during one-on-one partnering meetings with global and regional pharmaceutical companies.

KD is an acute inflammatory illness and the leading cause of acquired heart disease in children in developed nations. Up to 25% of untreated children with KD develop enlarged coronary arteries or CAAs. Patients with large CAAs are at risk for forming blood clots in those blood vessels – with a continuing lifelong risk for subsequent heart attacks and sudden cardiac death – and require chronic, precise anticoagulation therapy to reduce their higher risk of clot formation.

Tecarfarin is a novel, next-generation Vitamin K antagonist (VKA) that offers a number of potential advantages over warfarin, the current standard VKA in clinical use. Specifically, tecarfarin is designed to overcome limitations of warfarin metabolism and potentially provide more reliable and more consistent anticoagulation than might be possible with warfarin.

“Children with large or giant aneurysms due to KD represent an important underserved orphan population,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “The current standard of care – warfarin – is notoriously unstable in children because of dietary variations, concurrent medications, and genetic differences in liver metabolism. Tecarfarin is metabolized in a completely different way than warfarin, and is being developed to offer a highly stable, predictable alternative. We believe tecarfarin can potentially improve time in therapeutic range for these children, thereby lowering their risk for both catastrophic blood clots and dangerous bleeding events.”

The FDA’s RPDD program targets serious or life-threatening diseases that primarily affect fewer than 200,000 people in the United States from birth through age 18. If the FDA grants the designation and tecarfarin is subsequently approved for this indication, Cadrenal would be eligible to receive a Priority Review Voucher (PRV). These transferable vouchers can be used to accelerate the FDA review of a future drug or sold to another pharmaceutical manufacturer. Following Congress’s extension of the pediatric PRV program through September 30, 2029, recent open-market valuations for these vouchers have reached record highs, with recent sales ranging from $180 million to $205 million.

At the upcoming BIO International Convention, Cadrenal will present a dual-track portfolio strategy designed to maximize value for potential partners:

  • The Global Pharma Track: Focusing on CAD-1005, a first-in-class 12-LOX inhibitor. CAD-1005 is Phase 3-ready for Heparin-Induced Thrombocytopenia (HIT) and is advancing into a Phase 2a trial for Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI), addressing a combined, multi-billion-dollar dual-indication acute hospital care market.
  • The Regional & Rare Disease Track: Focusing on tecarfarin for Kawasaki disease. This program offers an efficient clinical trial design and strong geographic synergy, particularly for Japanese and East Asian pharmaceutical companies, where the incidence of Kawasaki disease is historically 10 to 15 times higher than in Western nations.

“Our presence at BIO 2026 centers on executing capital-efficient development strategies,” added Mr. Pham. “If we are successful in advancing tecarfarin toward a RPDD, we will create a high-value, de-risked regulatory pathway that aligns with regional partners’ portfolio needs while directing our core internal resources toward our blockbuster CAD-1005 critical care franchise.”

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics is a biopharmaceutical company advancing late-stage novel therapies for life-threatening immune and thrombotic conditions. The company’s pipeline includes CAD-1005, a novel first-in-class 12-LOX inhibitor targeting multiple critical care indications, and tecarfarin, a late-stage oral anticoagulant designed to avoid CYP450 metabolism. 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, for the treatment of Heparin-Induced Thrombocytopenia (HIT). CAD-1005 is also being developed for use in Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI), and second-generation 12-LOX oral therapeutics are in development for chronic indications.

About Tecarfarin

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. Tecarfarin has also received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration.

Safe Harbor Statement

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, without limitation, statements regarding plans to file for FDA Rare Pediatric Disease Designation for Tecarfarin in Kawasaki Disease; Cadrenal being eligible to receive a Priority Review Voucher and the value of the voucher; tecarfarin offering a number of potential advantages over warfarin, tecarfarin overcoming limitations of warfarin metabolism and potentially providing more reliable and more consistent anticoagulation than might be possible with warfarin; tecarfarin offering a highly stable, predictable alternative to warfarin; tecarfarin potentially improving time in therapeutic range for these children, thereby lowering their risk for both catastrophic blood clots and dangerous bleeding events and the successful advancement of tecarfarin creating a high-value, de-risked regulatory pathway that aligns with regional partners’ portfolio needs while directing the Company’s core internal resources toward its CAD-1005 critical care franchise Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to raise sufficient capital to continue progress of CAD-1005; the ability for tecarfarin to receive a Rare Pediatric Disease Designation for treatment of Kawasaki Disease; the ability to monetize a priority review voucher if received, the ability to successfully design and complete a dual-track portfolio strategy and maximize value for potential partners; the ability of tecarfarin to overcome limitations of warfarin metabolism and potentially provide more reliable and more consistent anticoagulation than might be possible with warfarin; the ability of tecarfarin offering a highly stable, predictable alternative to warfarin; tecarfarin potentially improving time in therapeutic range for children with Kawasaki Disease, thereby lowering their risk for both catastrophic blood clots and dangerous bleeding events and the successful advancement of tecarfarin creating a high-value, de-risked regulatory pathway that aligns with regional partners’ portfolio needs; ; the ability to successfully design and complete the Phase 3 study and derive the results needed for an NDA submission: and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, 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.

For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

For more information, please contact:

Lytham Partners, LLC, Robert Blum, Managing Partner, 602-889-9700, [email protected]

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Release – MAIA Biotechnology Opens Enrollment for Phase 2 Expansion Trial of Novel Telomere-Targeting Agent at Winship Cancer Institute of Emory University

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Research News and Market Data on MAIA

June 18, 2026 8:30am EDT Download as PDF

Georgia’s only National Cancer Institute (NCI)-designated Comprehensive Cancer Center; well recognized at the forefront of cancer innovation and discovery nationwide

CHICAGO, June 18, 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 third U.S. clinical site in its Phase 2 THIO-101 expansion trial, Winship Cancer Institute of Emory University (“Winship”), is activated and now enrolling patients. The trial studies MAIA’s lead investigational telomere-targeting agent, ateganosine, as a third-line (3L) treatment for non-small cell lung cancer (NSCLC).

Matthew Failor, Director of Clinical Operations for MAIA, commented, “Winship is Georgia’s only National Cancer Institute (NCI)-designated Comprehensive Cancer Center and is recognized at the forefront of cancer innovation and discovery nationwide. Winship offers a renowned thoracic oncology clinical research program with a proven track record in clinical trial development and conduct. With its premier medical team and extensive body of research, this cancer center is well-suited for our U.S. Phase 2 trial of ateganosine.”

The principal investigator for the THIO-101 expansion trial at Winship is Ticiana Leal, M.D., a professor in the Department of Hematology and Medical Oncology at the Emory University School of Medicine. Dr. Leal’s clinical research focuses on trials involving chemotherapy and immunotherapy agents for lung cancer.

Dr. Leal commented, “At Winship, we serve the state of Georgia and surrounding states where innovation in lung cancer treatment is a broad, underserved need. In Georgia, lung cancer is the leading cause of cancer-related deaths, with over 7,300 new cases in 2025. MAIA’s novel ateganosine agent, if approved, could address a significant gap in clinical care for the advanced-stage NSCLC patient population where there are no FDA-approved options available for treatment.”

THIO-101 is an ongoing Phase 2, open-label trial evaluating ateganosine followed by cemiplimab for NSCLC patients resistant to checkpoint inhibitors and chemotherapy. Parts A and B of the trial have shown strong early efficacy, with some patients showing survival exceeding two years, and now MAIA continues to expand the trial in the U.S.

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
+1 (872) 270-3518
[email protected]

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Source: MAIA Biotechnology, Inc.

Released June 18, 2026

Release – GeoVax Highlights Strategic Implications of Recent Gedeptin(R) Findings for Checkpoint-Resistant Cancers

Posted on by [email protected]
GeoVax

Research News and Market Data on GOVX

Recent Publication and Growing Industry Focus on Immune-Priming Strategies Support Continued Evaluation of Gedeptin® as a Potential Complement to Checkpoint Inhibitor Therapy

ATLANTA, GA – June 17, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines for solid tumors and infectious diseases, today highlighted the broader oncology and strategic implications of recently published research supporting the potential of its Gedeptin® platform to enhance immune checkpoint inhibitor activity and address one of the most significant challenges in modern cancer treatment: improving responses in checkpoint-resistant tumors.

The update follows publication of the peer-reviewed article, “Broadening Activity of Checkpoint Blockade Agents by Intratumoral Nucleoside Cleavage,” in JCI Insight. The study reported findings supporting the potential for Gene-Directed Enzyme-Prodrug Therapy (GDEPT) to enhance checkpoint inhibitor responses, activate systemic anti-tumor immunity, and generate anti-tumor effects in both treated and distant untreated tumors in preclinical models of checkpoint-resistant triple-negative breast cancer.

While the publication focused on the underlying scientific findings, GeoVax views the results as further validation of broader trends shaping the future of cancer immunotherapy, including increasing industry emphasis on immune-priming approaches designed to improve checkpoint inhibitor responsiveness and overcome treatment resistance.

Addressing the Challenge of Checkpoint Resistance

Checkpoint inhibitors targeting pathways, such as PD-1 and PD-L1, have transformed treatment paradigms across multiple cancer types and now represent foundational therapies in modern oncology. Despite their success, many tumors remain poorly responsive to checkpoint blockade due to limited immune-cell infiltration, poor antigen presentation, and immunosuppressive tumor microenvironments.

These so-called “cold” tumors represent one of the most significant barriers to effective immunotherapy. Without sufficient immune recognition and engagement, even highly active therapies may struggle to generate durable clinical responses.

GeoVax recently explored this challenge in an Onco’Zine commentary authored by Chairman and Chief Executive Officer David Dodd entitled, “The Cold Tumor Barrier: Why Promising Oncology Therapies Fail In Vivo – and What It Will Take to Overcome It”. The article discussed the growing recognition that future advances in immuno-oncology may depend not only on developing new therapies, but also on improving the responsiveness of tumors to existing treatments through immune activation and tumor microenvironment modulation.

As a result, substantial research and development efforts across the oncology sector are increasingly focused on identifying therapies capable of converting immunologically cold tumors into more responsive tumors, potentially expanding the number of patients who may benefit from immunotherapy and improving outcomes with established checkpoint inhibitor regimens.

“One of the most significant challenges in oncology today is the cold tumor barrier,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “Checkpoint inhibitors can be highly effective when sufficient immune activity already exists within a tumor. However, many tumors remain largely invisible to the immune system. The next major opportunity may lie in therapies capable of activating immune recognition and making these tumors more responsive to existing immunotherapies.”

Positioning Gedeptin Within an Emerging Immunotherapy Paradigm

GeoVax sees potential for Gedeptin to play a differentiated role within this evolving treatment landscape. The recently published findings suggest that localized treatment may not only destroy targeted tumor cells, but also remodel the tumor microenvironment, promote immune activation, and enhance responsiveness to checkpoint inhibitors. These characteristics are increasingly viewed as important components of next-generation combination immunotherapy strategies.

The Company views Gedeptin’s combination of localized tumor destruction, strong bystander killing effects, tumor microenvironment remodeling, and immune activation as a potentially differentiated approach to addressing treatment resistance.

“Importantly, Gedeptin is not necessarily intended to directly compete with checkpoint inhibitors, but rather to complement them,” continued Mr. Dodd. “The medical proposition is to improve responses where checkpoint inhibitors alone have not achieved their full potential; also representing a significant commercial opportunity with multiple partnering avenues.”

Focus on Neoadjuvant Combination Strategies

GeoVax’s lead clinical development focus for Gedeptin is a planned neoadjuvant study in recurrent head and neck squamous cell carcinoma (HNSCC), evaluating intratumoral Gedeptin in combination with PD-1-based immunotherapy and standard of care, in patients with first recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) eligible for curative-intent surgery.

The Company considers recurrent head and neck cancer an attractive initial development setting because tumors are frequently accessible for direct injection, checkpoint inhibitors are already integrated into standard of care treatment paradigms, and substantial unmet need remains despite advances in immunotherapy.

GeoVax also views the neoadjuvant setting as particularly well suited for immune-priming approaches because the intact tumor can serve as a source of tumor antigens capable of stimulating broader anti-tumor immune responses prior to surgical resection.

“As checkpoint inhibitors continue moving earlier in the treatment paradigm, opportunities are emerging for therapies designed to improve immune responsiveness before surgery and potentially improve long-term outcomes,” said Mr. Dodd. “Gedeptin’s biologic profile appears well aligned with this evolving treatment strategy.”

Broader Platform Opportunities

Beyond head and neck cancer, GeoVax sees potential applicability for Gedeptin across multiple solid tumor settings where checkpoint inhibitors are established standard of care but response rates remain suboptimal.

“The oncology community is increasingly focused on improving response rates to existing immunotherapies and overcoming the cold tumor barrier,” added Mr. Dodd. “The emerging data support continued evaluation of Gedeptin as a differentiated immune-priming platform designed to complement existing immunotherapies and potentially broaden the impact of checkpoint blockade across multiple tumor settings.”

About Gedeptin®

Gedeptin® is GeoVax’s proprietary gene-directed enzyme prodrug therapy (GDEPT) platform under development for the treatment of solid tumors. The therapy utilizes a non-replicating adenoviral vector encoding purine nucleoside phosphorylase (PNP). Following administration of fludarabine, the PNP enzyme converts the prodrug into a potent localized cytotoxic compound within the tumor microenvironment.

GeoVax is advancing development plans evaluating Gedeptin in combination with checkpoint inhibitors, including pembrolizumab-based regimens, with the goal of improving anti-tumor immune responsiveness across multiple solid tumor indications.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit www.geovax.com.

Forward-Looking Statements

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

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

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected] 

Release – MariMed Presents Fourth Annual Bob Fireman Entrepreneur of the Year Award to Weldon Angelos

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Research News and Market Data on MRMD

June 16, 2026 7:00am EDTDownload as PDF

Award Honors the Legacy of MariMed’s Late Co-Founder

NORWOOD, Mass., June 16, 2026 (GLOBE NEWSWIRE) — Leading multi-state cannabis operator MariMed Inc. (“MariMed”) (CSE: MRMD) (OTCQB: MRMD) proudly presented the Fourth Annual Bob Fireman Entrepreneur of the Year Award at a ceremony held June 15th during the 2026 IgniteIt Cannabis Capital Conference in Chicago. The recipient of this year’s award is Weldon Angelos, Founder of cannabis brand REEFORM and one of the nation’s leading advocates for criminal justice reform.

The Bob Fireman Entrepreneur of the Year Award honors the legacy of MariMed’s co-founder and CEO, who passed away in 2022. Fireman was a pioneer and visionary of the legal cannabis industry. He entered the industry in 2008 with his best friend and business partner, current MariMed CEO Jon Levine, through an investment in a California cannabis business. In 2014, they began building and leading MariMed, initially as an advisor to license holders before strategically transitioning into a vertically integrated multi-state operator. The Company also owns a portfolio of top-selling cannabis brands, including Betty’s Eddies™ fruit chews, the #1- selling edibles brand across its core states.

The award is presented annually to a cannabis industry executive who embodies Fireman’s entrepreneurial spirit and success, as well as his staunch advocacy for legal access to cannabis and social justice reform.

In 2003, Angelos’s low-level cannabis case resulted in a 55-year federal sentence. He became a symbol for justice reform over the years that followed before he was finally released from prison after receiving clemency from President Obama in 2016. Through his Mission [Green] initiative, Angelos is dedicated to helping free people incarcerated for cannabis, advocating for policy reform, and ending the war on drugs. Most recently, he played a key role in persuading the current Administration to reclassify cannabis to Schedule III of the Controlled Substances Act. His successful cannabis brand REEFORM exists as a platform to advocate for the release of those unjustly incarcerated and to help them rebuild their lives post release.

“Bob worked tirelessly as an advocate and an executive to improve people’s lives through cannabis. In fact, that remains MariMed’s mission today,” said MariMed CEO Jon Levine. “Weldon is the embodiment of everything Bob believed in and supported, both as a change-agent for reform and as the builder of a successful business. Bob would be extremely pleased that we are honoring Weldon with this year’s award.”

“I’m incredibly proud to be named this year’s recipient of the Bob Fireman Entrepreneur of the Year Award,” said Weldon Angelos. “From everything I have learned, Bob was the type of leader who understood what it means to do right while doing good. I’ve dedicated my life to cannabis reform and social injustice. Receiving this award means my efforts are making an impact. I am deeply honored but also know that our work is far from being done.”

About MariMed:
MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, Vibations™, InHouse™, and Nature’s Heritage™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.

Company Contact:
Howard Schacter
Chief Communications Officer
Email: [email protected]
Phone: (781) 277-0007

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Source: MariMed Inc.

Released June 16, 2026