Health Archives - Page 7 of 242

Greenwich LifeSciences, Inc. (GLSI) – FLAMIMGO-01 Trial Screening Rate Now Higher Than Expected

Posted on March 4, 2026March 4, 2026 by [email protected]

Wednesday, March 04, 2026

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

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Patient Screening Is Ahead Of Expectations. Greenwich LifeSciences reported a large increase in the rate of patient screening in the FLAMINGO-01 Phase 3 trial. The rate increased to about 200 patients per quarter, reaching an annual rate of over 800 per year, compared with the previous rate of 600 patients per year. The reflects an increased number of patients at existing sites as well as opening of additional sites in Europe. We see this increase in same-site and additional site screening as a positive sign for the trial.

Additional Data Release Coming Soon. In late February, Greenwich announced that two abstracts were accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting to be held April 17-22, 2026. The AACR plans to publish the abstract titles on March 17, followed by the full abstracts on April 17. The full posters will be published on the date of presentation at the conference.

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Release – MAIA Biotechnology Announces Pricing of $30 Million Underwritten Public Offering of Common Stock

Posted on March 3, 2026March 3, 2026 by [email protected]

Research News and Market Data on MAIA

March 02, 2026 10:45pm ESTDownload as PDF

Financing included participation by healthcare-dedicated investors alongside
existing shareholders

CHICAGO, IL, March 02, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced the pricing of its underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $1.50 per share for aggregate gross proceeds of $30 million, prior to deducting underwriting discounts and other offering expenses. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 3,000,000 shares of common stock at the public offering price per share, less the underwriting discounts to cover over-allotments, if any. The offering is expected to close on March 4, 2026, subject to satisfaction of customary closing conditions.

The offering was structured as a straightforward common stock only investment with no warrant coverage and was led by healthcare-dedicated investors alongside existing shareholders.

Konik Capital Partners, LLC, a division of T.R. Winston & Company is acting as the sole book-running manager for the offering.

MAIA intends to use the net proceeds from the offering to conduct clinical trials and for working capital and general corporate purposes.

The offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement.. A prospectus supplement describing the terms of the public offering will be filed with the SEC and will form a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to this offering have been filed with the SEC.

Copies of the prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting Konik Capital Partners LLC, a division of T.R. Winston & Company, at 7 World Trade Center, 46th Floor, New York, NY 10007, Attention: Capital Markets Team, Email: [email protected].

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

About MAIA Biotechnology

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.

Cautionary Note Regarding Forward-Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended). 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, (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and (viii) the closing of our underwritten public offering of common stock, 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. A detailed discussion of these uncertainties and risks that affect our business is contained in our SEC filings, including our reports on Form 10-K and Form 10-Q, particularly under the heading “Risk Factors.” 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]

Source: MAIA Biotechnology, Inc.

Released March 2, 2026

Release – Greenwich LifeSciences Provides Update on Increased Patient Screen Rate in FLAMINGO-01

Posted on March 3, 2026March 3, 2026 by [email protected]

Research News and Market Data on GLSI

Download as PDFMarch 03, 2026 6:00am EST

STAFFORD, Texas, March 03, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided an update on the increased patient screen rate in FLAMINGO-01.

FLAMINGO-01 Annual Patient Screen Rate Increases to Over 800 Patients per Year

Over the past 6 months, the Company achieved its highest screening rate of approximately 200 patients per quarter or the equivalent of over 800 patients per year in the US and EU sites, which is an approximately 33% increase over the prior reported annual screen rate of 600 patients per year. This increase is attributable to the new sites activated in 2025 and the increased patient driven momentum at existing sites.

CEO Snehal Patel commented, “While the approximately 33% increase to over 800 patients screened per year is impressive, marking our success in optimizing and expanding our clinical operations in 2025, we may have yet to see the peak screen rate for the study.”

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

About Greenwich LifeSciences, Inc.

Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.

Forward-Looking Statement Disclaimer

Statements in this press release contain “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 Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.

Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: [email protected]

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: [email protected]

Source: Greenwich LifeSciences, Inc.

Released March 3, 2026

Gyre Therapeutics, Inc (GYRE) – Cullgen Acquisition Adds New Platform To Build Long-Term Pipeline

Posted on March 3, 2026March 3, 2026 by [email protected]

Tuesday, March 03, 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.

Gyre To Acquire Cullgen. Gyre Therapeutics announced the acquisiton of Cullgen, a privately-held company developing targeted protein degrader (TPD) and degrader antibody conjugate (DAC) therapies. The all-stock transaction valued Cullgen at approximately $300 million. We believe this acquisition adds a novel technology platform to the mid-term to long-term product pipeline.

The Cullgen Acquisition Transforms Gyre. Cullgen was private company founded in 2018. It has been developing its proprietary technology platform, uSMITE (ubiquitin-mediated small molecule-induced target elimination), to create targeted protein degrading drugs and antibody conjugates. These drugs are in development to treat pain, cancer, inflammation, autoimmune diseases, and neurodegenerative diseases.

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

Release – MAIA Biotechnology Announces Proposed Underwritten Public Offering of Common Stock and Pre-Funded Warrants

Posted on March 2, 2026March 2, 2026 by [email protected]

Research News and Market Data on MAIA

March 02, 2026 5:00pm EST Download as PDF

CHICAGO, IL, March 02, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has commenced an underwritten public offering of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. All of the shares of common stock and pre-funded warrants to be sold in this offering are being offered by the Company. In addition, the Company intends to grant the underwriters a 30-day option to purchase additional shares of its common stock at the public offering price per share, less underwriting discounts and commissions. The proposed offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Konik Capital Partners LLC, a division of T.R. Winston & Company, is acting as the sole book-running manager for the offering.

MAIA intends to use the net proceeds from the offering to conduct clinical trials and for working capital and general corporate purposes.

The securities described above are being offered and sold pursuant to a “shelf” registration statement on Form S-3 (File No. 333-273984), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on August 15, 2023, and declared effective on August 23, 2023. This offering is being made only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement.

A preliminary prospectus supplement and accompanying prospectus related to and describing the terms of the offering has been or will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from Konik Capital Partners LLC, a division of T.R. Winston & Company, at 7 World Trade Center, 46th Floor, New York, NY 10007, Attention: Capital Markets Team, Email: [email protected].

Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference into such preliminary prospectus supplement and the accompanying prospectus, which provide more information about the Company and the offering.

About MAIA Biotechnology

Cautionary Note Regarding Forward-Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended). 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, (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and (viii) our proposed public offering of common stock and/or pre-funded warrants, 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. A detailed discussion of these uncertainties and risks that affect our business is contained in our SEC filings, including our reports on Form 10-K and Form 10-Q, particularly under the heading “Risk Factors.” 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]

Source: MAIA Biotechnology, Inc.

Released March 2, 2026

Release – MariMed Extends Series B Preferred Stock Obligation Through 2031, Strengthening Capital Structure

Posted on March 2, 2026March 2, 2026 by [email protected]

Research News and Market Data on MRMD

March 02, 2026 4:15pm ESTDownload as PDF

NORWOOD, Mass., March 02, 2026 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed” or “the Company”) (CSE: MRMD) (OTCQX: MRMD), a leading cannabis consumer packaged goods company and retailer, announced today that it has entered into a Restructuring and Exchange Agreement (the “Agreement”) with the holders (the “Holders”) of its $14.725 million Series B Convertible Preferred Stock (the “Series B Obligation”). The restructuring extends the maturity of the Company’s obligations on favorable market terms.

The Agreement eliminates the Company’s February 28, 2026 mandatory conversion date obligation and replaces it with a combination of long-dated instruments. As a result, the transaction extends the weighted average maturity of the obligation 4.6 years, significantly reducing near-term refinancing risk and enhancing the Company’s liquidity profile.

Under the Agreement, the Company issued:

a $2 million promissory note maturing in March 2028, bearing interest at 8 percent with a two-year term;
a $6 million promissory note maturing in March 2031, bearing interest at 10 percent with a five-year term; and
$6.725 million of Series B Convertible Preferred Shares, valued at $0.25 per share, which are subject to mandatory conversion in February 2031, unless converted earlier pursuant to its terms.

Additional details of the restructuring are available in a Form 8-K filed by the Company earlier today that is accessible on MariMed’s Investor Relations website at ir.marimedinc.com.

“We are pleased to successfully complete the restructuring, which meaningfully extends the maturity profile of the obligation and enhances our financial flexibility,” said MariMed CEO Jon Levine. “By eliminating this 2026 obligation, we have strengthened our balance sheet and positioned the Company to focus on executing our growth initiatives. The obligation as restructured includes both unsecured debt at favorable market rates and an equity component with a conversion feature at a significant premium to current market. We thank the Holders for their cooperative and collaborative approach to the restructuring and sharing the vision of MariMed’s future.”

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

Source: MariMed Inc.

Released March 2, 2026

RadNet Buys Gleamer, Building a Global Radiology AI Powerhouse

Posted on March 2, 2026March 2, 2026 by [email protected]

RadNet (NASDAQ: RDNT) is making a decisive move in healthcare AI. The Los Angeles-based outpatient imaging leader announced it has acquired Paris-based Gleamer SAS, integrating the business into its DeepHealth digital subsidiary. The all-cash deal, valued at up to €230 million including a post-closing milestone, positions DeepHealth as what the company describes as the largest provider of radiology clinical AI solutions worldwide.

For investors, the transaction underscores how artificial intelligence is shifting from pilot projects to scaled deployment across diagnostic imaging.

Gleamer brings more than 700 customer contracts across 44 countries and a cloud-first AI portfolio spanning musculoskeletal, breast, lung and neurologic applications. Its solutions include FDA-cleared and CE-marked products designed to support radiologists in screening, detection and workflow prioritization.

DeepHealth, RadNet’s digital health arm, already offers AI-enabled imaging tools across breast, chest, neuro, prostate and thyroid care. Combined, the companies report more than 2,700 customer contracts globally, a portfolio of 26 FDA-cleared and 22 CE-marked devices, and coverage across MR, CT, X-ray, mammography and ultrasound.

That breadth matters in a market where imaging volumes continue to rise while radiologist shortages persist worldwide.

RadNet CEO Dr. Howard Berger framed the deal around workflow automation—particularly in high-volume modalities like X-ray, ultrasound and mammography—where AI-enabled prioritization and draft reporting may help maintain access and efficiency.

Gleamer has operated under a SaaS model, generating annual recurring revenue (ARR) from subscription-based contracts. The company reported a compound annual ARR growth rate exceeding 90% from 2022 through 2025 and expects to reach approximately $30 million in ARR in 2026.

RadNet indicated that, on a combined basis, DeepHealth and Gleamer anticipate ARR approaching or exceeding $140 million by the end of 2026. ARR is a non-GAAP metric representing contracted recurring revenue and excludes one-time implementation and hardware sales.

For public market investors, recurring revenue visibility is increasingly central to valuation in health tech and AI-enabled platforms. The addition of Gleamer enhances DeepHealth’s cloud-native revenue base and expands its European footprint at a time when regulatory-cleared AI tools are gaining broader institutional adoption.

Beyond external sales, RadNet intends to deploy Gleamer’s AI capabilities across its own imaging network, which spans multiple U.S. states and performs millions of exams annually.

X-ray accounts for nearly 25% of RadNet’s imaging volume. The company expects AI-enabled triage and draft reporting tools to support productivity gains and workflow standardization, with deployment targeted by the third quarter of 2026.

Management has emphasized that benefits could include improved resource utilization and cost efficiencies. As with all integration efforts, realization of these outcomes depends on execution and adoption across clinical teams.

The acquisition arrives amid accelerating consolidation in healthcare AI, as imaging platforms seek both modality breadth and geographic reach. Hospitals and outpatient providers are increasingly evaluating enterprise-wide AI solutions rather than single-use tools.

By combining Gleamer’s automated reporting capabilities—already deployed in Europe—with DeepHealth’s imaging informatics platform, RadNet is aiming to deliver an integrated operating system approach across the radiology workflow.

Investors should view the transaction as part of a broader capital allocation strategy: pairing RadNet’s stable outpatient imaging cash flows with scalable digital health assets that carry higher growth profiles.

As AI moves from experimental deployments to embedded clinical infrastructure, scale, regulatory clearance and recurring revenue models are becoming competitive differentiators. RadNet’s latest acquisition suggests the next phase of radiology AI will be defined less by innovation alone—and more by integration at enterprise scale.

Release – Gyre Therapeutics Enters into Agreement to Acquire Cullgen to Gain Targeted Protein Degradation Platform and Pipeline

Posted on March 2, 2026March 2, 2026 by [email protected]

Research News and Market Data on GYRE

March 2, 2026

PDF Version

Acquisition will create a U.S.- and China-based fully integrated biopharmaceutical company with revenue-producing commercial assets and a robust pipeline of degraders, targeting inflammatory diseases and cancers.
Access to degrader-antibody conjugates (DACs) platform technology for future discovery engine.
Strengthened leadership team designed to support future global growth.
Transaction is anticipated to close early in the second quarter of 2026.
An updated corporate presentation has been posted to the Gyre and Cullgen websites.

SAN DIEGO, March 02, 2026 (GLOBE NEWSWIRE) — Gyre Therapeutics, Inc. (Gyre or the Company) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic diseases, today announced its agreement to acquire Cullgen Inc. (Cullgen), a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader (TPD) and degrader antibody conjugate (DAC) therapies, in an all-stock transaction valued at approximately $300 million. Following the closure of the acquisition, the new combined entity will be a fully integrated biopharmaceutical company with U.S.- and China-based capabilities spanning from discovery to manufacturing and commercialization and covering multiple therapeutic areas including inflammatory diseases, cancers, and pain.

Under the terms of the definitive agreement, Cullgen will become a wholly owned subsidiary of Gyre. Upon the completion of the acquisition, the interim Chief Executive Officer and Executive Chairman of Gyre, Ping Zhang, will remain as the Executive Chairman. The current Chief Executive Officer of Cullgen, Dr. Ying Luo, is expected to become the President and Chief Executive Officer and a member of the board of directors of Gyre.

Dr. Luo, the expected President and Chief Executive Officer of Gyre, commented, “We are thrilled about the synergistic coalescing of our companies. Cullgen brings strong drug discovery capabilities and a solid preclinical and clinical pipeline to complement Gyre’s existing and highly efficient China-based manufacturing capabilities and sales team. Gyre is already a commercial-stage company with ETUARY® on the market in China for the treatment of lung fibrosis and a second product for liver fibrosis, Hydronidone (F351), nearing New Drug Application (NDA), submission in China. Gyre is also exploring the expansion of F351’s development in ex-China territories. Following the acquisition, we will have a fully integrated biopharmaceutical company that will be capable of leveraging emerging drug discovery capabilities in China and strong clinical development in the United States to address unmet medical needs worldwide. I am excited for the potential of TPDs and DACs to drive this Company’s future growth globally.”

Mr. Zhang, Chairman of Gyre, commented, “Recently, Gyre, through its majority owned subsidiary, Gyre Pharmaceuticals, had a pre-NDA meeting with the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) which supported a conditional approval and priority review eligibility filing for Gyre Pharmaceuticals’ first-in-class anti-liver fibrosis candidate, Hydronidone, subject to formal approval. As a result, Gyre Pharmaceuticals plans to submit an NDA for Hydronidone for conditional approval in the first half of 2026 and conduct a Phase 3c confirmatory trial to support full approval in China. The addition of Cullgen’s TPD/DAC platform and pipeline is expected to enhance our long-term growth prospects. We are excited to have Cullgen colleagues join our team in both the United States and China.”

The transaction is expected to close early in the second quarter of 2026, subject to customary closing conditions, including necessary regulatory approvals in the United States.

Prior to entering into this transaction, Cullgen’s proposed merger with Pulmatrix was terminated.

Updated Corporate Presentation

In connection with this announcement, a new presentation has been posted on each company’s respective website. Visit http://www.cullgen.com or http://www.gyretx.com.

About Cullgen Inc.

Cullgen is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader and DAC therapies designed to improve the lives of patients suffering from critical conditions such as pain, cancer and inflammatory diseases. Cullgen has created a portfolio of highly selective targeted protein degrader product candidates designed to potently and efficiently eliminate therapeutically relevant proteins in patients. By leveraging its expertise in targeted protein degraders, Cullgen believes its product candidates have many distinct advantages over other therapeutic modalities, including higher selectivity, improved therapeutic profile and avoidance of known toxicities.

Cullgen’s lead product candidate, CG001419, is an oral pan-tropomyosin receptor kinase (TRK) degrader that previously completed a Phase 1 trial for the treatment of acute post-operative pain and Cullgen released positive top-line results from the study in late 2025. Cullgen recently submitted an IND for the molecule, and pending FDA allowance, expects to initiate a Phase 2 trial in acute pain in bunionectomy patients in the United States. The molecule is also being studied in a Phase 1 trial for the treatment of solid tumors. Cullgen’s second product candidate, CG009301, is a GSPT1 degrader being studied in a Phase 1 trial for the treatment of blood cancers, including relapsed/refractory acute myeloid leukemia, higher-risk myelodysplastic syndrome and acute lymphoblastic leukemia. In addition to CG001419 and CG009301, Cullgen is also progressing a number of preclinical programs including next-generation degrader-antibody conjugates.

For more information, please visit www.cullgen.com.

About Gyre Pharmaceuticals

Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY^® (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.8 million). In addition, Gyre Pharmaceuticals’ pipeline includes Hydronidone, a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. Hydronidone received Breakthrough Therapy designation by the CDE of the NMPA in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. As of the third quarter of 2025, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals.

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis including MASH in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the PRC, Gyre is advancing a broad pipeline through its controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.

Advisory and Legal Counsel

Moelis & Company LLC is acting as financial advisor to the special committee to Gyre’s Board of Directors, and Gyre’s legal counsel is Gibson, Dunn & Crutcher LLP.

Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. is serving as legal counsel to Cullgen.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the structure, timing and completion of the proposed acquisition; the anticipated timing of closing; the expected executive officers and directors of the combined entity; the future operations of the combined entity; the nature, strategy and focus of the combined entity; the development and commercial potential and potential benefits of any product candidates of the combined entity; and anticipated clinical drug development activities and related timelines, including the anticipated timing of the filing of Gyre’s NDA with the NMPA for the conditional approval of Hydronidone and the initiation of the confirmatory Phase 3c clinical trial of Hydronidone to support full approval in China and the anticipated timing of Cullgen’s Phase 2 trial of its TRK degrader in acute pain. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the risk that the conditions to the closing of the acquisition are not satisfied; uncertainties as to the timing of the consummation of the acquisition and the ability of each of Gyre and Cullgen to consummate the acquisition; risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the acquisition; unexpected costs, charges or expenses resulting from the acquisition; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the acquisition; the uncertainties associated with Gyre’s and Cullgen’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; risks related to the inability of the combined entity to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks associated with the possible failure to realize certain anticipated benefits of the acquisition, including with respect to future financial and operating results. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025, and in other filings with the Securities and Exchange Commission.

Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACTS:

Gyre Therapeutics, Inc.
Ping Zhang, interim CEO and executive chairman
[email protected]

Cullgen Inc.
Thomas Eastling, CFO
[email protected]

Investors
Chuck Padala
Managing Director, LifeSci Advisors
[email protected]

Release – Cadrenal Therapeutics Highlights Recent 12-LOX Inhibitor Platform Expansion

Posted on March 2, 2026March 2, 2026 by [email protected]

Research News and Market Data on CVKD

Encouraging data for CAD-1005 in Phase 2 HIT Study

EOP2 scheduled for Q1 for top-priority indication

Additional acute and chronic opportunities for 12-LOX inhibition beyond HIT

PONTE VEDRA, Fla., March 02, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company developing therapies for life-threatening immune and thrombotic disorders, today provided additional perspectives on development opportunities following its recent pipeline expansion with the addition of 12-LOX inhibitors.

As previously announced, Cadrenal recently acquired a portfolio of selective 12-LOX inhibitors, including oral candidates. Encouraging recent data from a blinded, placebo-controlled Phase 2 study of CAD-1005, a parenteral 12-LOX inhibitor, in heparin-induced thrombocytopenia (HIT) demonstrated a reduction in thrombotic events on a background of standard anticoagulants, with an End-of-Phase 2 (EOP-2) meeting scheduled for later this month.

While HIT remains Cadrenal’s near-term regulatory priority with CAD-1005, an ever-growing body of scientific research supports the central role that 12-LOX also plays in inflammatory signaling across multiple high-impact disease areas. Published studies have highlighted its role in atherosclerosis and vascular inflammation, microvascular thrombosis, ischemia-reperfusion injury, and immune-mediated metabolic conditions, including beta-cell stress pathways associated with type 1 diabetes and obesity.

Collectively, these therapeutic areas represent multi-billion-dollar potential global markets and opportunities to address novel pathways and potentially improve otherwise poor patient outcomes. Cadrenal’s new 12-LOX inhibitor portfolio is a differentiated platform approach across a range of thrombotic and inflammatory conditions, with both acute and chronic potential applications.

“We are very excited to have the only selective 12-LOX inhibitor currently in clinical-stage development and continue to move forward with HIT as our lead indication and regulatory priority,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “We also appreciate that 12-LOX inhibition represents an entirely new – and exciting – therapeutic approach and are optimistic that safely and selectively targeting 12-LOX can have far-reaching therapeutic implications in multiple disease areas.”

About 12-LOX

Lipoxygenases are a family of enzymes involved in lipid metabolism that stimulate the incorporation of oxygen into polyunsaturated fatty acids. The enzymatic action of 12-LOX ultimately leads to the formation of 12-HETE, a lipid molecule that easily crosses cell membranes. Intracellularly, 12-HETE promotes oxidative stress, while extracellularly, 12-HETE modulates a variety of signaling pathways to regulate inflammatory activity and elicit pro-inflammatory effects. In human blood, 12-LOX is found primarily in platelets and leukocytes; it is also found within the pancreas of diabetics and in certain cancer cells. In HIT, 12-LOX is a critical link in platelet activation via the IgG receptor. Early attempts to develop 12-LOX inhibitors failed because they were not 12-LOX specific. CAD-1005 is the first successful selective 12-LOX inhibitor and the only one to advance to clinical-stage development.

About CAD-1005

CAD-1005 is an investigational therapy being evaluated for the treatment of suspected HIT. CAD-1005 is designed to selectively inhibit 12-LOX, a pathway integral to the primary immune mechanisms driving HIT. Unlike existing therapies for HIT, which are only directed at preventing thrombotic complications, this approach addresses the primary underlying cause of HIT. In preclinical models of HIT, CAD-1005 has been shown to prevent or treat HIT and halt the development of both thrombocytopenia and blood clots. The drug has not been associated with increased bleeding in animals or healthy human volunteers. CAD-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration and orphan drug status from the European Medicines Agency.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is a first-in-class 12-LOX inhibitor for the treatment of 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 under development for chronic indications.

The Company’s broader pipeline includes tecarfarin, a Phase 3-ready oral vitamin K antagonist for patients with end-stage kidney diseases and left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor designed for use in acute hospital settings.

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

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include Cadrenal’s development opportunities following its acquisition of a 12-LOX inhibitor portfolio; the EOP-2 meeting being scheduled with the FDA for later this month; HIT remaining Cadrenal’s near-term regulatory priority with CAD-1005; the therapeutic areas for Cadrenal’s 12-LOX inhibitor portfolio representing multi-billion-dollar potential global markets and opportunities to address novel pathways and potentially improve otherwise poor patient outcomes; and being optimistic that safely and selectively targeting 12-LOX can have far-reaching therapeutic implications in multiple disease areas. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including Cadrenal’s ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; Cadrenal’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; Cadrenal’s ability to obtain or maintain the capital or grants necessary to fund its research and development activities; regulatory limitations relating to Cadrenal’s ability to promote or commercialize its product candidates for specific indications; acceptance of Cadrenal’s product candidates in the marketplace and the successful development, marketing or sale of its products; Cadrenal’s ability to maintain its license agreements; Cadrenal’s ability to retain its key employees or maintain its Nasdaq listing and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:

Matthew Szot, CFO

[email protected]

Investors:

Lytham Partners, LLC

Robert Blum, Managing Partner

602-889-9700

[email protected]

Release – Ocugen Announces Phase 3 liMeliGhT Enrollment Completion for OCU400, a Novel Modifier Gene Therapy for Broad Retinitis Pigmentosa

Posted on March 2, 2026March 2, 2026 by [email protected]

Research News and Market Data on OCGN

March 2, 2026

PDF Version

Enrollment for liMeliGhT, the first and largest gene therapy registrational trial for broad retinitis pigmentosa (RP) patients, was completed, reflecting strong interest from investigators and patients
Topline Phase 3 data expected in 1Q 2027, advancing OCU400 towards potential approval in 2027 as a treatment option for early- to late-stage RP
Positive long-term, 3-year Phase 1/2 durable, safety and tolerability data for OCU400 demonstrates sustained clinically meaningful, approximately 2-line LLVA gain, reinforcing durable gene-agnostic benefit

MALVERN, Pa., March 02, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that enrollment is now complete for the OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa (RP). As a one-year clinical trial, topline data will be available in the first quarter of 2027. These data are anticipated to support the Biologics License Application (BLA) filing for OCU400 and potential approval in 2027. The European Medicines Agency (EMA) has also provided acceptability of the U.S.-based trial for submission of a Marketing Authorization Application (MAA).

“With enrollment complete for OCU400, we enter into a very significant time as a Company,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “This milestone brings us even closer to potentially delivering our first novel modifier gene therapy candidate to market and providing a one-time treatment for life to hundreds of thousands of RP patients across the globe with unmet medical need.”

The liMeliGhT clinical trial enrolled 140 patients who were randomized 2:1 into the treatment group (2.5×¹⁰ vg per eye 250 µL) and untreated control group across mutations (RHO and gene-agnostic arms). The target population included patients with early- to late-stage disease among a broad RP population, including pediatrics (3+ years). The primary endpoint is 12-month change in visual function assessed by LDNA (luminance dependent navigation assessment) with improvement in Lux Level from baseline to 12 months. LDNA is a more sensitive and specific mobility test, proprietary to Ocugen.

“The Phase 3 liMeliGhT clinical trial includes representation of a wide range of gene mutations associated with early to advanced stages of RP and we believe the patient response will support the gene-agnostic mechanism of action of our novel modifier gene therapy platform,” said Dr. Huma Qamar, Chief Medical Officer of Ocugen. “I want to thank the investigators and clinical research teams for their tireless recruitment efforts and coordination among the trial sites to achieve the enrollment milestone. This dedication has the potential to shift the treatment paradigm for RP by targeting multiple genetic mutations with a single therapeutic approach.”

The OCU400 Phase 3 liMeliGhT clinical trial is the only broad RP gene-agnostic trial and the largest known Phase 3 orphan gene therapy trial.

“It is critical to work towards FDA-approved treatment options that address the significant gap that remains for the approximately 98% of people living with RP who are not candidates for the approved gene therapy for RP,” said Victor H. Gonzalez, Valley Retina Institute, McAllen, Texas, Faculty at University of Texas Rio Grande Valley and the Primary Investigator for the liMeliGhT clinical trial. “I am enthusiastic about the possibility of offering my patients with RP a safe, effective and durable treatment option that could potentially stabilize vision loss or improve vision.”

Positive long-term, 3-year Phase 1/2 data for OCU400 was recently assessed in evaluable subjects and builds on prior 2-year results showing consistent clinically meaningful, approximately 2-line LLVA gain across mutations. OCU400 maintained a favorable durability, safety and tolerability profile with no new treatment-related serious adverse events or adverse events of interest emerged. Additional data include:

Visual function benefits were consistently observed over 3 years, with 88% (7/8) of evaluable treated subjects showing improvement or preservation versus untreated fellow eyes
Approximately 2-line gain (N=8) observed across multiple mutation types in treated eyes compared to untreated eyes at 3 years

Enrollment completion in the OCU400 Phase 3 clinical trial combined with positive 3-year data from the Phase 1/2 study are important accomplishments in the Company’s plan to begin bringing this potential gene therapy to patients in 2027. Ocugen remains on track to file the rolling BLA in the third quarter of 2026.

About OCU400
OCU400 is the Company’s modifier gene therapy candidate based on a nuclear hormone receptor gene called NR2E3. This gene regulates diverse physiological functions within the retina, such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation, and cell survival. Retinal cells in RP patients have a dysfunctional gene network, and OCU400 is designed to reset this network to reestablish a healthy cellular homeostasis—which has the potential to improve vision in patients with RP.

About RP
RP is a group of rare genetic disorders that cause a breakdown in the cells of the retina, leading to vision loss and blindness. RP is associated with mutations in more than 100 genes.

There are no approved treatment options that slow or stop the progression of multiple forms of RP. Proposed treatments for RP include gene replacement therapy, retinal implant devices, retinal transplantation, stem cells, vitamin therapy, and other pharmacological treatments. Current gene replacement therapies are promising but are limited to treating just a single mutation. In addition, while gene therapies may provide a new functional gene, they do not necessarily eliminate the underlying genetic defect, which may still cause stress and toxic effects leading to retinal degeneration. Therefore, the development of gene-specific replacement therapy will not address all forms of RP, especially when multiple and unknown genes are involved. Thus, novel therapeutic approaches targeting the broader RP disease in a gene-agnostic manner offer additional hope for patients.

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

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU400 to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
[email protected]

MAIA Biotechnology (MAIA) – Ateganosine Moves Forward With A Pivotal Year Ahead

Posted on March 2, 2026March 2, 2026 by [email protected]

Monday, March 02, 2026

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

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

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

Building On Success In 2025, Ateganosine Continues Moving Forward. MAIA has been conducting the Phase 2 THIO-101 trial, testing ateganosine (also known as THIO) in combination with cemiplimab, a checkpoint inhibitor. The trial is now in its third stage after the data showed meaningful improvements in median survival, overall response rates, and disease control rate. Separately, a Phase 3 trial has begun. Based on the reported results, we believe both trials have a high probability of success and could lead to FDA approvals.

Phase 2 THIO-101 Could Support Early Approval. The THIO-101 trial was designed with three stages. Part A confirmed safety and tolerabity, while Part B tested three doses to determine the optimal dosing regimen. In December 2025, the Part C Expansion/Registration stage began. This is an open-label arm designed to determine the Overall Response Rate (ORR). Positive data could lead to an application for Early Approval from the FDA.

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

Cardiff Oncology (CRDF) – FY2025 Reported With Onvansertib Phase 2b Data Review

Posted on February 26, 2026February 26, 2026 by [email protected]

Thursday, February 26, 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.

FY2026 Reported With Onvansertib Review. Cardiff reported a FY2025 loss of $45.8 million or $(0.69) per share and reviewed the clinical data for onvansertib, its drug for RAS-mutated metastatic colorectal cancer (mCRC). Updated plans for Phase 3 are expected after discussions with the FDA during 1H26. On December 31, 2025, Cardiff ended the year with $58.3 million in cash and equivalents, which it believes can fund operations through 1Q27.

Phase 2 CRDF-004 Trial Design. The CDRF-004 Phase 2 trial was designed to test two doses of onvansertib in combination with two standard-of-care (SOC) regimens against each standard of care regimen alone. It enrolled 110 patients with RAS-mutated mCRC. The primary endpoint was objective response rate (ORR).

Get the Full Report

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

Biotech’s 2026 Capital Window: Why Clinical-Stage Companies Are Preparing Now

Posted on February 26, 2026February 26, 2026 by [email protected]

Clinical development is inherently capital intensive. As programs move from early-stage studies into Phase 2 and Phase 3 trials, costs typically rise due to expanded enrollment, multi-site coordination, manufacturing scale-up, and regulatory preparation.

Companies such as Eledon Pharmaceuticals, which is advancing immune-modulating therapies, and Cardiff Oncology, focused on targeted oncology treatments including onvansertib, illustrate the type of clinical-stage businesses navigating these funding dynamics. As programs mature, capital planning becomes increasingly tied to milestone timing.

Similarly, Ocugen, with gene therapy and ophthalmology-focused programs, and Cocrystal Pharma, which develops antiviral therapeutics, operate in segments where development timelines and regulatory pathways can require sustained financial flexibility.

Even companies earlier in commercialization strategy development, such as Nutriband, which is advancing transdermal pharmaceutical technologies, must balance product advancement with capital market realities.

These examples reflect a broader sector pattern: advancing innovation requires consistent access to funding.

The Importance of the Catalyst Calendar

Biotech financing windows often open around meaningful clinical or regulatory catalysts. Positive data can strengthen negotiating leverage. But waiting until after results are announced can introduce risk — particularly if broader market conditions shift.

With 2026 shaping up to include a number of anticipated data readouts across the industry, companies are evaluating whether to raise capital ahead of milestones, opportunistically during periods of sector strength, or in response to results.

Preparation matters.

Management teams that establish investor visibility and maintain consistent communication before catalysts emerge may find themselves better positioned if and when market windows open.

M&A Activity Is a Tailwind — Not a Strategy

Large pharmaceutical companies continue to evaluate external pipelines to supplement internal research efforts. Periodic acquisition activity can improve sentiment across small-cap biotech and help reset valuation benchmarks.

However, M&A remains selective and unpredictable. Most clinical-stage companies must plan under the assumption that equity or structured financing will remain the primary funding path.

For investors, that distinction is important.

Why Capital Strategy Matters for Shareholders

In small-cap biotech, capital access influences more than just cash runway. It can affect development pace, trial continuity, partnership leverage, and dilution levels.

A company that secures funding under stable market conditions may retain greater operational flexibility. One that is forced to raise under pressure may encounter less favorable terms.

As 2026 approaches, the differentiator may not simply be who generates data — but who manages capital strategy effectively alongside clinical execution.

Biotech remains data-driven and inherently volatile. Yet improving sector sentiment and a growing milestone calendar suggest that capital formation decisions could play a defining role in shaping outcomes over the next 12–18 months.

For small-cap investors, understanding both the science and the financing strategy may be equally important in the year ahead.