Category: Health

Greenwich LifeSciences, Inc. (GLSI) – Modifications To Phase 3 FLAMINGO-01 Trial Raise Probability Of Success

Posted on by [email protected]


Tuesday, July 21, 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.

Trial Modifications Announced. Greenwich Pharmaceuticals announced modifications to the Phase 3 FLAMINGO-01 trial testing GLS-100 for the prevention of recurrent breast cancer. Several changes reflect preliminary findings and allow for increased enrollment in the pivotal arm of the trial. We believe the changes increase the likelihood of positive results in the interim and the final analyses, as well as potentially doubling the market.

The Original Phase 3 Design. The original trial design screened patients for HLA type, an immune system classification. Patients with HLA-A*02, the most common type, were randomized into two double-blind arms testing GLSI-100 against a placebo control. The non-HLA-A*02 patients were entered into an open-label arm. Following the standard of care treatment for breast cancer, patients were given six monthly doses of GLSI-100, then boosters every 6 months for 11 total doses.


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Release – Greenwich LifeSciences Provides Clinical Updates on FLAMINGO-01

Posted on by [email protected]
Greenwich LifeSciences

Research News and Market Data on GLSI

 Download as PDF July 20, 2026 6:00am EDT

STAFFORD, Texas, July 20, 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 GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following clinical updates on FLAMINGO-01.

FLAMINGO-01 Data Safety Monitoring Board (DSMB)

The FLAMINGO-01 DSMB met in May 2026 and recommended the study continue as is without modification.

FLAMINGO-01 Steering Committee Clinical Strategy

On December 22, 2025, the company announced the following objectives:

“The Steering Committee also met at SABCS 2025 and discussed the clinical strategy, endorsing the planned modifications to FLAMINGO-01. The planned modifications subject to regulatory approval include:

  • increasing the size of the study, which would increase the power of the study thus decreasing the risk by designing the study to assume more recurrences even though fewer recurrences may be anticipated and observed,
  • doubling or quadrupling the enrollment rate, which will increase the patient years in the study more rapidly thus proportionately increase the event rate, which may shorten the time to reach an interim analysis or milestone,
  • continuing to enroll past the interim analyses so that the current momentum at the clinical sites continues,
  • using the interim analysis to potentially resize the study or to change the subsequent interim analysis, to change the number of events triggering an analysis, or to change the timing of the study based on recommendations by an independent committee, and
  • using a recently manufactured GP2 commercial drug product lot in FLAMINGO-01″

CEO Snehal Patel commented, “We are pleased to announce that following review by FDA and EMA regulatory authorities that these objectives have been met and that FLAMINGO-01 now has the hallmarks of a large pharma Phase III clinical trial. The study is now designed and sized to improve the probability of success, to attract the interest of sophisticated investors and pharma companies, and to maximize the chances that the Company could file a BLA after interim analysis 1, after interim analysis 2, or after the end of the study.”

Mr. Patel further added, “The transition is now underway globally at all sites. We have provided below in this press release the details of the study design reviewed by both the US and EU agencies, and currently subject to review by the UK and Canada, and will be updating the Company website and presentation, www.ClinicalTrials.gov, and videos accordingly. These agencies may provide additional recommendations or requirements at any time and we remain flexible to accommodate their advice as needed.”

The Company plans to now leverage the increased enrollment rate resulting from the combination of all HLA types together with the following: 1) the very high interest from patients and clinicians which has led to almost 200 clinical trial sites in the US and Europe, 2) the clinical operational capability in place 3) the currently trending low event rate, and 4) the efficient cost structure and burn rate that the Company has successfully funded through small capital raises.

Enrollment Rate into the Blinded Arm

As previously disclosed, all European and US Sites will combine all new patients independent of HLA type in the randomized arms of FLAMINGO-01. Non-HLA-A*02 patients who represent about 55% of the population and were on waiting lists for up to a year are now eligible for enrollment, which could provide for the rapid enrollment of up to 300 patients. This protocol amendment will more than double the enrollment rate increasing it by 122% or resulting in a 2.22x faster enrollment rate (55%/45% = 122%), which proportionately increases the event rate. This more than doubling of the event rate, provides an opportunity to derisk the study and provide multiple pathways to filing a BLA in the US with much higher probabilities of success at each opportunity for analysis.

Leveraging the High Interest from Patients and Clinicians

The Company has achieved a major milestone by screening over 1,500 patients in Flamingo-01, continuing its screening rate of approximately 150-200 patients per quarter or the equivalent of 600-800 patients per year in approximately 170-180 sites.

The 11 participating countries include: US, Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, Belgium, and Austria. The Company is planning to add the following additional European countries due to interest from principal investigators and patients: Norway, Denmark, and Sweden in addition to the UK and Canada.

Rationale to Keep Enrollment Open Until Interim Analyses

In the double-blinded arms of the Phase III trial, the originally designed 500 HLA-A*02 patients were likely to be filled before the interim analysis and thus the clinical sites would have had to stop enrolling. If the interim analysis suggested that more patients should be enrolled, restarting enrollment would have been very difficult. A 2.22x increase in the enrollment rate without any other modifications would have accelerated the stopping of enrollment, but the probability of a successful data analysis at the interim analysis and the filing of BLA would not be increased. It isn’t in the study’s best interest to wait for more events without the option to continue enrolling to increase the event rate. It is optimal to keep enrolling while collecting events because even patients in the study for only a short time are at risk of recurrence and can add information to analyses.

Capital Raising Strategy Has Kept up with Modestly Increasing Burn Rate

The cash burn will be manageable as in the past due to the efficiently run and internalized clinical operations. The manufacturing of GP2 vials for the Phase III clinical trial has been completed with sufficient vials to treat all patients. Most of the start-up costs for the clinical sites have been paid. Many patients have entered the booster phase with 2 vaccinations per year with lower costs thus offsetting the higher costs for patients entering the study, when 6 vaccinations in the first 6 months during the primary immunization series are required.

The Company’s annual burn rate was approximately $7 million in 2024 and 2023 and $10 million in 2025. The income statements for these periods have been reported as much higher losses, but the cash flow used for operations is much lower due to the non-cash stock and options expenses added to the income statements.

For the second quarter of 2026, the burn rate is expected to be approximately $2 million versus a $4.7 million burn rate in the first quarter of 2026, leading to a Q2 2026 cash balance of approximately $8.9 million as of June 30, 2026 and an expected burn rate of $2-4 million per quarter going forward. The above preliminary financial figures are unaudited and are subject to change following completion of the Company’s financial review for Q2 2026. This capital raising strategy may provide a bridge to non-dilutive funding, such as strategic/licensing partnerships or debt/royalty financing vehicles, that would further fund FLAMINGO-01 and potential commercial launch activities.

Improved Trial Design Allows for Substantial Reduction in Risk

In the double-blinded arms of the Phase III trial, the trial has been designed to detect a hazard ratio (HR) of 0.55 in invasive breast cancer-free survival, where 28 events will be required for the 1st interim analysis, 56 events will be required for the 2nd interim analysis, and 133 events will be required to end the study. Interim analyses for superiority and futility will be conducted and, if successful, could lead to the filing of a BLA in the US at those times. The number of patients enrolled in the study will depend on the event rate and thus enrollment may continue for as long as necessary up to a maximum of 2,000 patients. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater and the HR is 0.55. In addition, the number of events may be adapted by the DSMB based on interim analyses.

By doubling the number of events to trigger an interim and increasing the HR, which is offset by the more than doubling event rate due to the higher enrollment rate, and may or may not alter time lines, the probability of a positive study outcome can be increased substantially. An increase of the HR puts FLAMINGO-01 more in line with other prominent large pharma breast cancer Phase III clinical trials such as Katherine for Kadcyla and Destiny Breast-05 for Enhertu. The HR is equal to one minus the percent reduction in events caused by the treatment arm. For example, an HR = 0.3 would suggest a 70% reduction in events and an HR = 0.75 would suggest a 25% reduction in events by the treatment arm.

The Katherine study which compared Kadcyla to Herceptin breast cancer treatment in the adjuvant setting after surgery in the residual disease population assumed a design HR = 0.75 but realized a lower study result HR at the first interim of 0.5, which led to a sufficiently low p value and strong enough statistical significance to warrant approval for Kadcyla in the adjuvant setting following submission of interim data to the FDA. Approximately 1,486 patients were enrolled, 256 events were observed at the interim analysis, and 385 events were observed at the final analysis.

The Destiny Breast-05 study which compared Enhertu to Kadcyla breast cancer treatment in the adjuvant setting after surgery, in a higher risk residual disease population than Katherine, assumed a design HR = 0.675 but realized a lower study result HR at the first interim of 0.5, which led to a sufficiently low p value and strong enough statistical significance to warrant approval for Enhertu in the adjuvant setting following submission of interim data to the FDA. Approximately 1,635 patients were enrolled and 153 events were observed at the interim analysis.

GLSI-100 by contrast has shown a study result HR = 0.2 in the Phase IIb clinical trial for HLA-A*02 patients. In the 250 patient non-HLA-A*02 open label arm of FLAMINGO-01, which is now fully enrolled and where all patients received GLSI-100, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate or a HR = 0.2-0.3 when calculated by various methods. This data is early and will continue to mature over time. This low event rate is supported by immune response data that was recently published at AACR and ASCO conferences in 2026. The section below, “About FLAMINGO-01 Open Label Phase III Data”, summarizes these results and provides links to the posters at the conferences.

By increasing the original FLAMINGO-01 trial design HR = 0.3 to a design HR = 0.55 and by doubling the events required to trigger the first interim analysis from 14 to 28 events, the probability of success or power at the first interim analysis, if a lower study result HR = 0.3 is realized, increases from less than 20% to more than 85%. This increase in power at the first interim, when the study result HR is lower than the design HR, is possible due to the combination of both HLA types, while the more than double event rate at 2.22x offsets the doubling of the events required to trigger this first interim analysis. Effectively increasing the probability of filing a BLA at the first interim analysis from 20% to 85% justifies the study design changes.

Additional benefits of the new design include:

  • The first interim results may affect or alter the design of the second interim.
  • Endpoints can be analyzed by individual HLA types as well as one combined group of all HLA types and given that each patient has 2 HLA-A alleles, one from each parent, there are multiple analyses that can be conducted.
  • Doubling the market for GLSI-100 to potentially $10 billion in revenue per year by accelerating the clinical development of the non-HLA-A*02 population.
  • Capital raise requirements are still modest, based on the Company’s disciplined operations and low burn rate.

About FLAMINGO-01 Open Label Phase III Data

More than 1,500 patients have been screened at a screen rate of approximately 600-800 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 70-80% reduction in recurrence rate.
  • The non-HLA-A*02 arm 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. 
    • The AACR Meeting 2026 delayed-type-hypersensitivity (DTH) poster and the ASCO Meeting 2026 injection site reaction (ISR) poster can be seen and downloaded at the bottom of the Phase III clinical trial tab on the Company’s website here.
    • As shown in both posters the frequency of DTH and ISR reactions increased statistically significantly over time.
    • As reported in Table 1 of each poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline.
    • Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated.

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 posters and results can be summarized as follows and can be seen here:

  • 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 170-180 sites globally.

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. In the US and Europe, there are approximately 700,000 new breast cancer patients per year and 9.5 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, 2025, 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]

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Source: Greenwich LifeSciences, Inc.

Released July 20, 2026

Release – Gyre Therapeutics Appoints Three New Members to its Board of Directors

Posted on by [email protected]

Research News and Market Data on GYRE

July 16, 2026

PDF Version

SAN DIEGO, July 16, 2026 (GLOBE NEWSWIRE) — Gyre Therapeutics, Inc. (“Gyre”, “Gyre Therapeutics” or the “Company”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company with operations in the United States and China, today announced that its Board of Directors has appointed three new members, effective August 1, 2026: Yue Xiong, Ph.D., the Company’s Chief Scientific Officer; Maxwell (“Max”) Kirkby; and Claire Weston, Ph.D. With these appointments, the Board expands its scientific, clinical development, and cross-border biopharmaceutical operating expertise as Gyre advances its broad pipeline of products targeting numerous therapeutic areas including fibrosis, cancer, inflammation and pain.

Dr. Xiong will serve as a Class I director, with a term expiring at the Company’s 2028 annual meeting of stockholders. Mr. Kirkby will serve as a Class II director, with a term expiring at the Company’s 2029 annual meeting of stockholders, and has also been appointed to the Compensation Committee of the Board. Dr. Weston will serve as a Class III director, with a term expiring at the Company’s 2027 annual meeting of stockholders, and has been appointed to the Audit Committee of the Board.

“We are pleased to welcome Max and Claire to our Board, and to formally recognize Yue’s expanded role as a director,” said Dr. Ying Luo, President and Chief Executive Officer of Gyre. “Max brings decades of cross-border drug development experience spanning China, Japan, the U.S. and Europe, which is directly relevant as we continue to advance our programs through the clinic worldwide and expand our global footprint. Claire’s background building and scaling life sciences companies, together with her operating and governance experience, will strengthen our Audit Committee as we grow as a public company. And Yue’s deep scientific leadership, both in ubiquitin biology and in building Cullgen’s degrader platform, has already been instrumental to our pipeline — we’re glad to have his perspective formally represented at the Board level. Together, these appointments reflect our continued commitment to strong governance as Gyre advances its portfolio of clinical assets and targeted protein degrader and degrader-antibody conjugates platforms.”

About the New Directors

Yue Xiong, Ph.D.

Dr. Xiong has served as Gyre’s Chief Scientific Officer since May 2026. Dr. Xiong previously served as a member of the board of directors of Cullgen, Inc., a biopharmaceutical company, from 2018 until the closing of Cullgen’s merger with Gyre, and as Chief Scientific Officer of Cullgen from August 2020 until closing of Cullgen’s merger with Gyre. After completing a postdoctoral fellowship in cell biology at Cold Spring Harbor Lab, Dr. Xiong joined the Department of Biochemistry and Biophysics at University of North Carolina at Chapel Hill in 1993. He was a William R. Kenan Professor of Biochemistry and Biophysics from January 2005 to July 2020, where he was responsible for classroom teaching and laboratory mentoring of students and trainees, conducting research, recruitment and mentoring of junior faculty and participating other university activities. From September 2006 to July 2020, Dr. Xiong also led the Cancer Cell Biology Program the UNC Lineberger Comprehensive Cancer Center, where he was responsible for organizing program activity such as monthly seminars, annual retreat and symposium, preparing annual program progress report to NCI and competing renewal cancer center core grant, and other research activity in the cancer center. Dr. Xiong has an undergraduate degree from Fudan University and a Ph.D. in Biology from the University of Rochester. Dr. Xiong has received several awards for his scholarship and research, published more than 200 research articles in peer-reviewed journals and is a named inventor on two U.S. patents. He was elected as a fellow of American Association for the Advancement of Science (“AAAS”) in 2012.

Maxwell Kirkby

Maxwell Kirkby is the co-owner of Huang and Kirkby Pharma Consulting, a consulting company that he co-founded in May 2024. Mr. Kirkby previously served in various leadership roles at Bristol-Myers Squibb Company, a global biopharmaceutical company, including as the Executive Director and Head of R&D Strategy, China, from March 2022 to May 2024 and Interim Head of R&D, China from May 2023 to November 2024. Prior to joining Bristol-Myers, Mr. Kirkby served as the Executive Director and Head of Japan & Asia Pacific Development at Amgen Inc., a global biopharmaceutical company, from February 2020 to March 2022. Prior to joining Amgen, from August 1989 to January 2020, Mr. Kirkby held positions of increasing responsibility at AstraZeneca plc, a global biopharmaceutical company, most recently serving as VP of Development, China.

Claire Weston, Ph.D.

Claire Weston, Ph.D. is the Founder & Chief Executive Officer of Tactus AI LLC an AI healthcare company, which she has led since January 2025. Dr. Weston previously served as a member of the Executive Leadership Team and a Board Observer at CellCarta Biosciences, Inc., a private biotechnology company, from May 2021 to February 2023. Dr. Weston founded and served as the Chief Executive Officer of Reveal Biosciences Inc., a private AI-powered digital pathology platform, from June 2012 until the company was acquired by CellCarta Biosciences in May 2021. She also served as the Chair of the Board of Directors of Reveal Biosciences from 2019 to May 2021. Prior to this, Dr. Weston served as senior scientist at Vala Sciences, Inc., a private biotechnology company, from April 2011 to July 2012. Dr. Weston was a Board Director for Athena, a non-profit supporting women in STEM, from January 2020 to December 2022. Dr. Weston received a B.Sc. in Biotechnology from Cardiff University and a Ph.D. in Cell Biology from the University of Cambridge and completed postdoctoral studies at the UMass Chan Medical School.

About Gyre Pharmaceuticals

Gyre Pharmaceuticals Co., Ltd., a subsidiary of Gyre Therapeutics, Inc., 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 over the past several years. In addition, Gyre Pharmaceuticals’ pipeline includes F351 (hydronidone), 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. In May 2026, China’s National Medical Products Administration (NMPA) accepted Gyre Pharmaceutical’s New Drug Application (NDA) for F351 as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). F351 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 March 31, 2026, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals.

About Gyre Therapeutics

Gyre Therapeutics is a commercial-stage biopharmaceutical company headquartered in San Diego, CA focused on the development and commercialization of small-molecule therapeutics with its most advanced programs addressing organ fibrosis and inflammatory diseases.

Gyre’s wholly-owned subsidiary, Cullgen Inc., is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader and degrader-antibody conjugate (DAC) therapies for critical conditions including cancer and inflammatory diseases. Cullgen has created a portfolio of highly selective targeted protein degrader and DAC product candidates designed to potently and efficiently eliminate therapeutically relevant proteins in patients.

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 expected contributions of the newly appointed directors to the Company’s strategy and governance. 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. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2025 filed on March 13, 2026, 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.

Thomas Eastling, CFO
[email protected]

Investors

Chuck Padala
Managing Director, LifeSci Advisors
[email protected]

Release – Greenwich LifeSciences Announces European Approval for Combining Both HLA Populations in FLAMINGO-01

Posted on by [email protected]
Greenwich LifeSciences

Research News and Market Data on GLSI

 Download as PDF

July 16, 2026 7:30am EDT

STAFFORD, Texas, July 16, 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 GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following update on the combination of both HLA-A*02 and non-HLA-A*02 patients in FLAMINGO-01 in Europe.

All European and US Sites to Combine All Patients Independent of HLA Type in the Randomized Arms of FLAMINGO-01

The Company previously announced that US clinical sites started enrolling both HLA-A*02 and non-HLA-A*02 patients in the same randomized arms in FLAMINGO-01, based on the FDA’s review of such protocol changes, effectively more than doubling the enrollment rate of the pivotal arm of the study. Non-HLA-A*02patients who represent about 55% of the population and were on waiting lists for up to a year are now eligible for enrollment.

The European Medicines Agency (EMA) has completed their review and will also allow the combination of both HLA-A*02 and non-HLA-A*02 patients in Europe. Thus, all 170-180 clinical sites in the US and Europe, are now operating under the same protocol and could continue enrolling up to the first interim analysis. Data can be analyzed by individual HLA types as well.

Additional feedback is expected from UK and Canadian regulators. The Company plans to provide updates regarding the resulting improved trial design, including a pathway for the Company to now pursue approval for both HLA-A*02 and non-HLA-A*02 patients using the increased statistical power of a combined analysis of the two patient groups together potentially doubling the market for GP2 by accelerating the clinical development of the non-HLA-A*02 population.

About FLAMINGO-01 Open Label Phase III Data

More than 1,300 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 70-80% 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.
    • The AACR Meeting 2026 delayed-type-hypersensitivity (DTH) poster and the ASCO Meeting 2026 injection site reaction (ISR) poster can be seen and downloaded at the bottom of the Phase III clinical trial tab on the Company’s website here.
    • As shown in both posters the frequency of DTH and ISR reactions increased statistically significantly over time.
    • As reported in Table 1 of each poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline.
    • Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated.

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 posters and results can be summarized as follows and can be seen here:

  • 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 170-180 sites globally.

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, 2025, 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]

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Source: Greenwich LifeSciences, Inc.

Released July 16, 2026

Eli Lilly Pays $3.8 Billion for AtaiBeckley as Big Pharma’s Push Into Mental Health Enters a New Phase

Posted on by [email protected]

The pharmaceutical industry’s appetite for neuroscience innovation just produced one of the most significant mental health deals in years. Eli Lilly (NYSE: LLY) announced Wednesday it has entered into a definitive agreement to acquire AtaiBeckley (Nasdaq: ATAI), a clinical-stage biopharmaceutical company developing rapid-acting therapies for treatment-resistant depression and other serious mental health conditions. The deal values AtaiBeckley at approximately $2.8 billion in upfront equity consideration, with an additional $1.0 billion in potential milestone-based contingent value rights, bringing the total potential transaction value to approximately $3.8 billion.

AtaiBeckley shareholders will receive $6.75 per share in cash at closing, representing a 40% premium to the stock’s 30-day volume-weighted average trading price. The contingent value rights are tied to specific development and regulatory milestones across the company’s two most advanced programs. The transaction is expected to close in the third quarter of 2026.

What Lilly Is Acquiring

AtaiBeckley’s pipeline is built around a class of compounds called rapid-acting neuroplastogens, therapies designed to restore the brain’s ability to form and strengthen neural connections in regions critical to mood regulation. This is a fundamentally different approach from conventional antidepressants, which primarily target neurotransmitter levels. The distinction matters because treatment-resistant depression, by definition, persists after multiple conventional treatments have failed. Millions of Americans live with it, and the clinical need for a genuinely new mechanism of action is substantial.

The lead asset, BPL-003, is a synthetic form of 5-MeO-DMT delivered as a nasal spray. In a Phase 2b study, the compound demonstrated rapid and durable reductions in depressive symptoms following a single in-clinic visit lasting approximately two hours on average, with beneficial effects persisting for months. The FDA has granted BPL-003 Breakthrough Therapy Designation and Phase 3 activities are already underway.

The second program, VLS-01, is a buccal film formulation of DMT currently advancing in a Phase 2b study for treatment-resistant depression. A third asset, EMP-01, is an R-MDMA compound in Phase 2 development for social anxiety disorder. Together, the pipeline represents one of the most clinically advanced portfolios in the emerging psychedelic-derived therapeutics space.

The Bigger Picture for Neuroscience M&A

Lilly’s move into mental health through the AtaiBeckley acquisition reflects a growing recognition across the pharmaceutical industry that neuroscience, and specifically psychiatry, represents one of the largest underserved therapeutic markets remaining. The company framed the deal explicitly as an expansion of its neuroscience pipeline to address conditions where existing treatments consistently fall short.

The deal structure itself reveals how large pharma is approaching risk in this space. The $2.8 billion upfront payment secures the pipeline and the Phase 3 asset immediately. The $1.0 billion in CVRs ties additional payments to clearly defined regulatory and development milestones, aligning incentives between buyer and seller while limiting downside if programs do not advance as planned.

What It Signals for Small Cap Biotech

For investors tracking clinical-stage neuroscience and CNS-focused companies in the small and microcap space, the Lilly-AtaiBeckley transaction sends a direct signal. Large pharma is now willing to pay nearly $4 billion for a pre-revenue mental health company with Breakthrough Therapy Designation and Phase 3 readiness. That valuation framework applies to other companies advancing differentiated CNS programs through mid-to-late-stage development, including names like NeuroSense Therapeutics, both of which are developing therapies targeting neurological and psychiatric conditions with significant unmet need.

The biotech M&A wave that began with GSK-Nuvalent and AbbVie-Apogee earlier this year has now expanded beyond oncology into neuroscience. The message from large pharma is consistent: validated clinical data, Breakthrough Therapy Designation, and clear regulatory paths in large patient populations are commanding premium valuations regardless of therapeutic area. The pipeline of small cap companies fitting that profile remains deep.

Release – Tonix Pharmaceuticals Announces Publication in the Peer-Reviewed Journal of Virology Assessing Virulence of the 2022 Outbreak Strain of Mpox in New Animal Models

Posted on by [email protected]
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Research News and Market Data on TNXP

July 15, 2026 9:05am EDT Download as PDF

Data show clade IIb from 2022 outbreak is 100 to 100,000-fold less virulent than clade IIa from 2003 outbreak

Three new models for investigating mpox infection and pathogenesis identified

Tonix is advancing TNX-801, a live, attenuated, minimally replicative investigational vaccine candidate based on horsepox virus to protect against mpox disease

BERKELEY HEIGHTS, N.J., July 15, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial-stage biotechnology company, today announced the publication of a paper, “Monkeypox virus clade IIb isolate exhibits reduced virulence relative to clade IIa isolates in multiple murine models,” in the Journal of Virology, the peer-reviewed publication of the American Society for Microbiology (ASM). The research, conducted at Tonix, found new animal models for investigating mpox pathogenesis and demonstrated significant differences in virulence between the clade IIb circulating in the U.S. and the historic 2003 clade IIa. The manuscript can be accessed at:
https://doi.org/10.1128/jvi.00247-26.

“Global mpox outbreaks that have caused severe human disease continue to occur due to previously unrecognized subclades,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “New approaches to understand and mitigate the spread of emerging mpox subclades are urgently needed. To examine the pathogenesis of emerging mpox clades, we identified three new murine models susceptible to mpox clade II infection, which revealed significant differences in virulence between clades. As Tonix investigates TNX-801 (live attenuated horsepox vaccine) for the prevention of mpox and smallpox, establishing additional foundational models are important to categorize and ultimately protect against the disease.”

“The decreased virulence of clade IIb may have contributed to its ability to spread worldwide,” said Sina Bavari, Ph.D., Executive Vice President of Tonix and site head of Tonix’s Research and Development Center (RDC) in Frederick, Maryland. “Indolent subclinical infection is a risk factor for unintentional spread. Importantly, a deeper understanding of mpox virus (MPXV) pathogenesis will help guide the continued development and positioning of the TNX-801 vaccine platform, a vaccine candidate against mpox. Tonix is committed to advancing the understanding of emerging mpox disease and to developing TNX-801 platform as a potential vaccine candidate to address the continuing global threat posed by mpox.”

Led by Farooq Nasar, Ph.D., Director, Virology, Tonix utilized its state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility, at RDC which is close to the center of the U.S. biodefense research community.

Mpox is an emerging human disease caused by four distinct MPXV subclades (Ia, Ib, IIa, and IIb). Despite their genetic similarities, the case fatality rates differ considerably among the subclades: Ia (~11%), Ib and IIa (~4%), and IIb (~0.2%). Since 2022, multiple mpox outbreaks caused by the previously unrecognized Ib and IIb subclades have led the World Health Organization to declare two Public Health Emergencies of International Concern. Cases are currently increasing in multiple regions of the Americas. This unprecedented global spread and the marked differences in disease severity among MPXV subclades underscore the importance of investigating the pathogenesis of emerging MPXV variants. However, a critical limitation has been the lack of suitable small animal models.

This publication expands on the previously established CAST/EiJ mouse model by evaluating susceptibility to MPXV subclade IIa and IIb infection in both 7- to 8-week-old and 4- to 5-month-old mice. The demonstrated susceptibility of older CAST/EiJ mice to clade IIa infection highlights the utility of this model for evaluating long-term vaccine durability and protective efficacy. In addition, the study describes three novel C57BL/6 mouse models deficient in the interferon-α receptor, interferon-γ receptor, or both receptors for the study of MPXV infection. The study demonstrates that the emerging clade IIb isolate is up to 100,000-fold less virulent than clade IIa isolates. Collectively, these models provide valuable new tools for rapidly investigating the pathogenesis of emerging MPXV subclades and evaluating medical countermeasures, including vaccines.

About Mpox

Mpox is an acute contagious disease caused by the monkeypox virus or MPXV, which is also a member of the orthopoxvirus family. Mpox is emerging as an important zoonotic infection in humans in Central and West Africa. Until 2022, only a few cases of mpox were reported outside of Africa in patients who had been infected while in Africa. Starting in May of 2022, mpox clade II cases spread rapidly in the U.S. and other countries. The World Health Organization (WHO) declared mpox clade IIb to be a public health emergency of international concern (PHEIC). The clade II mpox affects mostly men who have sex with men in the U.S., where it has become endemic. The WHO lifted PHEIC designation for clade Ib. In August 2024, the WHO declared mpox clade Ib to be a PHEIC due to an outbreak in the Democratic Republic of the Congo that spread globally, including to the U.S. clade Ib affects children and adults. Although the WHO has lifted PHEIC designation for clade Ib, mpox continues to spread in Africa, and mutations of the virus are considered by public health experts to be an ongoing threat to be monitored for new epidemic spread.

About TNX-801

TNX-801 (recombinant horsepox virus) is an attenuated, minimally replicative, live virus vaccine based on horsepox in pre-clinical development to prevent mpox and smallpox. TNX-801 is expected to enter a Phase 1 study in 2027 pending FDA clearance of an Investigational New Drug Application (IND). TNX-801 is in the pre-IND stages of development.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is extending the science behind TONMYA in Phase 2 clinical studies to evaluate the potential of TNX-102 SL in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S. and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and smallpox. Tonix has been awarded a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Maryland. Within immunology, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome. To learn more, visit www.tonixpharma.com.

*Tonix’s product development candidates, including TNX-102 SL for new, unapproved indications, are investigational new drugs or biologics. Their efficacy and safety have not been established and have not been approved for any indication.

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

Forward-Looking Statements

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

Contacts

Deborah Elson (Investors/Media)
Tonix Pharmaceuticals
[email protected]
[email protected]  

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

Andrea Cohen (Media)
Sam Brown Inc.
(917) 209-7163
[email protected]

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Source: Tonix Pharmaceuticals Holding Corp.

Released July 15, 2026

Biotech IPOs Doubled in the First Half of 2026. The Funding Window for Small Cap Drug Developers Has Not Been This Wide in Years

Posted on by [email protected]

The biotech sector spent the better part of three years locked out of the public markets. That era appears to be decisively over. Eighteen biotech companies completed initial public offerings in the first half of 2026, exactly double the eight that went public during the same period in 2025, according to data from BioSpace. Two of those listings, Kailera Therapeutics at $625 million and Parabilis Medicines at $670 million, shattered the previous record for the largest biotech IPO ever, a title Moderna had held since 2018.

The numbers are not just higher in volume. They are higher in conviction. The median biotech IPO in 2026 raised approximately $287.5 million, more than double the equivalent figure from early 2025 and the highest quarterly median since the pandemic-era peak of 2021. Eleven of the thirteen venture-backed biotechs that priced offerings in the first half secured at least $250 million. Investors are writing larger checks for fewer companies, and the companies receiving that capital are performing after they get to Wall Street. Most of the 2026 class is currently trading at or above its debut price.

Why the Window Opened

Two forces converged to create this environment, and they are reinforcing each other. The first is a surge in mergers and acquisitions. In Q1 2026 alone, the biopharma sector recorded 19 exits valued at $13.3 billion, the highest exit value since the fourth quarter of 2021. Deals like GSK’s $10.6 billion acquisition of Nuvalent and AbbVie’s $10.9 billion purchase of Apogee Therapeutics have demonstrated that large pharma will pay significant premiums for clinical-stage assets in high-priority therapeutic areas. That M&A activity is directly fueling IPO appetite because the companies going public increasingly resemble the exact profiles that large pharma is hunting.

The second force is a return to regulatory predictability at the FDA. The agency has moved toward greater use of advisory committees and is re-evaluating applications that previously received complete response letters, creating a more navigable path for companies with mid-to-late-stage clinical programs. The combination of active acquirers and a more transparent regulatory environment has restored investor confidence in the sector’s ability to generate returns.

What It Means for Existing Small Cap Biotechs

The implications extend well beyond the companies actually going public. A healthy IPO market lifts the entire clinical-stage biotech ecosystem. When newly public companies trade well, it signals to institutional investors that the sector is functioning again, which draws capital back into the broader small cap biotech universe, including the hundreds of companies already listed and advancing their own programs.

The therapeutic areas attracting the most capital align closely with where patent cliffs are creating the most urgency for large pharma acquirers. Oncology remains a dominant focus, with companies like Cardiff Oncology, MAIA Biotechnology, and Greenwich LifeSciences all advancing clinical programs in areas where large pharma has demonstrated a clear willingness to pay for innovation. Cardiovascular disease emerged as a significant theme in H1, with Kardigan’s $400 million offering anchored around late-stage cardiac assets. Immunology, neuroscience, and rare disease continue to draw investor interest as well, with companies like Eledon Pharmaceuticals developing differentiated programs in therapeutic areas where unmet need and commercial opportunity intersect.

The second half is expected to accelerate further. Nasdaq has estimated that a dozen additional biotech IPOs could price in Q3 alone, and companies like Scribe Therapeutics, co-founded by CRISPR pioneer Jennifer Doudna, are already in the filing process. The biotech funding window has not been this open since 2021. The difference this time is that the market is rewarding discipline, clinical data, and clear regulatory paths rather than early-stage platforms and promises. That distinction is what makes this cycle more durable than the last one.

Release – Cardiff Oncology Announces $10 Million Registered Direct Offering

Posted on by [email protected]
Cardiff Oncology, Inc. logo

Research News and Market Data on CRDF

July 15, 2026

PDF Version

SAN DIEGO, July 15, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF) (the “Company”), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 8,571,429 shares of its common stock and accompanying warrants to purchase up to an aggregate of 8,571,429 shares of its common stock, at a purchase price of $1.05 per share and accompanying warrant in a registered direct offering. In addition, certain members of the Company’s officers and directors are participating in the offering and have entered into definitive agreements for the purchase and sale of an aggregate of 731,707 shares of the Company’s common stock and accompanying warrants to purchase up to an aggregate of 731,707 shares of the Company’s common stock, at a purchase price of $1.435 per share and accompanying warrant. The warrants will have an exercise price of $1.31 per share, will be exercisable beginning on the later of (i) six months after issuance and (ii) the effective date of the increase of the Company’s authorized shares of common stock following stockholder approval, and will expire five and one-half years from the initial exercise date. The closing of the offering is expected to occur on or about July 16, 2026, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $10 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The securities described above are being offered pursuant to a “shelf” registration statement (File No. 333-285327) filed with the Securities and Exchange Commission (“SEC”) on February 27, 2025 and declared effective on May 13, 2025. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the securities being offered will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [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 the registration or qualification under the securities laws of any such state or jurisdiction.

About Cardiff Oncology, Inc.

Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.

For more information, please visit https://www.cardiffoncology.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the completion of the offering; the satisfaction of customary closing conditions related to the offering; the intended use of proceeds from the offering; the receipt of stockholder approval; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; uncertainty as to the outcome of pending litigation against Nerviano Medical Sciences S.r.l. with respect to our license agreement with Nerviano; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the SEC. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Investor Contact:
Candice Masse
astr partners
[email protected]

Media Contact:
Amy Bonanno
Lyra Strategic Advisory
[email protected]

Release – MariMed’s Betty’s Eddies™ Expands Core Lineup with New Multi-Vitamin Inspired Betty’s Bite-A-Mins

Posted on by [email protected]
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Research News and Market Data on MRMD

July 14, 2026 7:00am EDT Download as PDF

New Tropical Smoothie-Flavored Chews Combine 30mg of CBD, Full-Spectrum Cannabis, Vitamin C, Zinc, and a Full Daily Dose of Vitamin D3 in One Convenient Bite

NORWOOD, Mass., July 14, 2026 (GLOBE NEWSWIRE) — Betty’s Eddies™, the all-natural cannabis fruit chews handcrafted for specific health and wellness effects, is expanding its core lineup with the introduction of Betty’s Bite-A-Mins, a daily wellness chew that combines full-spectrum cannabis, CBD, and essential vitamins in one delicious bite. Betty’s Eddies is one of the top-selling and award-winning brands developed and distributed by leading multi-state cannabis operator, MariMed Inc. (“MariMed”) (CSE: MRMD) (OTCQB: MRMD).

Developed in response to consumer demand for higher CBD potency options, Betty’s Bite-A-Mins represent Betty’s Eddies’ innovative take on the daily multivitamin category. The new sku features a bright tropical smoothie flavor made with all-natural ingredients and organic fruits. Each chew contains 30mg of CBD along with the recommended daily allowance of Vitamin C, Vitamin D3, and Zinc. Delivered in a convenient, flavorful chew, Betty’s Bite-A-Mins offers consumers an easy way to incorporate cannabinoids and wellness-focused ingredients into their everyday lives.

“Wellness has always been at the heart of Betty’s Eddies, and our consumers consistently tell us they’re looking for products that fit seamlessly into their daily routines,” said Sara Rosenfield, Brand Director for Betty’s Eddies. “With Betty’s Bite-A-Mins, we listened to that feedback and created a core product that delivers a higher dose of CBD alongside vitamins many people already take every day. The result is a delicious tropical smoothie chew that makes daily wellness simple, enjoyable, and accessible.”

The launch comes as consumers increasingly seek functional wellness products that combine multiple benefits in a single format. As interest in both cannabinoids and preventative wellness continues to grow, shoppers are looking for convenient products that integrate ingredients such as vitamins, minerals, and cannabinoids into their everyday routines. The new sku will be available at MariMed’s Thrive Dispensary locations and other licensed cannabis retailers throughout Massachusetts, Maryland, Illinois, Delaware, Maine, and Rhode Island.

Betty’s Bite-A-Mins joins a full slate of Betty’s Eddies products that feature specific end-effects, including Bedtime Betty’s for restful nights, Take It Easy Eddies for stress relief, Go Betty Go for an energy boost, Ache Away Eddies for pain relief, Ache Away Eddies PM for a pain-free night’s sleep, Betty’s Caramelt Away for cozy melty moments of mellow, and more.

Visit www.bettyseddies.com to learn more about Betty’s Bite-A-Mins and to find a dispensary where they’re available.

About Betty’s Eddies
Betty’s Eddies™ all-natural fruit chews are handcrafted with full-spectrum cannabis, supporting cannabinoids, and herbal supplements and vitamins. Designed for whatever life throws at you, varieties include pain relief, immunity, energy, sleep and more. Founded in 2014 by medical cannabis patients on a mission to craft the best tasting and most effective edibles, best-selling Betty’s Eddies encompass the full spectrum of the plant’s benefits, including natural adaptogens, and are handcrafted in small batches with real organic fruits and vegetables. Find Betty’s Eddies in licensed dispensaries in Delaware, Maryland, Illinois, and Massachusetts. Learn more at www.bettyseddies.com.

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.

Media Contact:
Zach Galasso
DPA Communications 
Email: [email protected]
Phone: (978) 604-5423

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

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Source: MariMed Inc.

Released July 14, 2026

NanoViricides (NNVC) – NanoViricides Announces Phase 2 Ebola Trial Approval and Prepares Next Regulatory Filing

Posted on by [email protected]


Tuesday, July 14, 2026

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

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

Phase 2 Ebola Trial Advancing As Expected. Nanoviricides announced that it has received approval from the National Ethics Committee in the Democratic Republic of Congo (DRC) for its Phase 2 clinical trial of NV-387 in Ebola. The next step is the filing of a Clinical Trial Application with ACOREP, the DRC regulatory authority. This meets one of our expected milestones to start of patient treatment during summer 2026.

Two Phase 2 Trials Should Begin In A Matter of Weeks. The approval by the National Ethics Committee was a step in the process of starting clinical trials in the DRC. The company has shipped the clinical supplies of NV-387 and is preparing for a Phase 2 trial in MPox and a separate Phase 2 trial in Ebola. We expect regulatory approvals in the next several weeks to allow both trials to begin treating patients during summer 2026 through fall 2026.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Cadrenal Therapeutics (CVKD) – CAD-1005 Phase 2 Trial Data In HIT Presented at ISTH Meeting

Posted on by [email protected]


Tuesday, July 14, 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.

CAD-1005 Phase 2 Study Reported At Medical Meeting. Cadrenal presented data from its Phase 2 trial testing CAD-1005 in HIT (Heparin Induced Thrombocytopenia) at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress. As discussed in our Research Note on February 25, the trial did not meet its Primary Endpoint, but successfully characterized CAD-1005 and had unanticipated findings that were better than expected.

CAD-1005 Reduced Thrombotic Events Without Platelet Recovery. The Phase 2 placebo-controlled trial was designed to test CAD-1005 with standard anticoagulant therapy. Its Primary Endpoint was an improvement in platelet recovery, a biomarker for predicting thrombotic events and outcome. This primary endpoint did not meet statistical significance, although the secondary endpoint of reduction in thrombotic events showed a clinically meaningful improvement.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – As Ebola Spreads in Two More Provinces, NanoViricides Has Received National Ethics Committee Approval for a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for Ebola in Congo

Posted on by [email protected]
As Ebola Spreads in Two More Provinces, NanoViricides Has Received National Ethics Committee Approval for a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for Ebola in Congo

Research News and Market Data on NNVC

Monday, 13 July 2026 09:27 AM

Topic: 

Company Update

SHELTON, CT / ACCESS Newswire / July 13, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”), a clinical stage leader developing antiviral drugs that viruses cannot escape, announces that it has received National Ethics Committee approval for a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for the Current Bundibugyo Ebolavirus in the Democratic Republic of Congo (DRC). The Company is now getting ready to file a Clinical Trial Application to ACOREP, the regulatory agency in DRC.

NanoViricides has already put together a team with a renowned Principal Investigator and with support from a well known University in the Ebola-affected region for the execution of this clinical trial after regulatory approvals.

NV-387 Oral Gummies Drug Product has already been shipped to DRC, because of the ensuing Phase II clinical trial of NV-387 for the Treatment of Mpox. Sufficient quantity of NV-387 drug product is thus available in DRC for starting the clinical trial against Ebola as well.

The Ebola outbreak in the DRC continues to increase in spread. It has spread to two more northeastern provinces, Haut-Uele and Tshopo, and number of confirmed Ebola cases across the country rose to 1,926, including 702 deaths, official data showed late on Sunday, the country’s public health institute said in its latest report [1].

There is no approved Treatment or Vaccine for the new variant of the Bundibugyo Ebolavirus (BDBV) that is causing the current rapidly expanding outbreak of the Ebolavirus Disease (EVD) in DR Congo and Uganda. The rare Bundibugyo strain of Ebola virus causing the current outbreak appears to be its new variant, likely freshly introduced from some animal source[2], such as fruit bats.

NV-387 is the only orally active agent under consideration for clinical trial as a treatment of Ebola to the best of our knowledge. In an epidemic scenario in resource limited settings such as in DRC, oral drug is a highly advantageous feature.

“We believe NV-387 could be revolutionary in this fight against Ebola, if it is found to be effective,” said Anil R. Diwan, PhD, adding, “It is an oral drug, in contrast to other infusions. Thus evaluating if NV-387 treatment works is of paramount importance to combat this and future Ebola and Marburg outbreaks.”

Other treatments require infusions. Infusions are difficult to implement and also are not scalable in a large outbreak scenario if this Ebola virus outbreak continues to grow, as has been widely expected.

A clinical trial of an antibody cocktail MBP134, alongside MBP134 plus Remdesivir, has started as per WHO with first patient having received infusion of the antibody cocktail on July 2, 2026 [3]. Monoclonal antibodies are highly specific to the strain of virus and usually are not effective against unrelated strains.

Further, viruses readily escape antibodies after exposure to them.

In contrast, NV-387 is a broad-spectrum antiviral that mimics the host-side features that the virus requires, and is likely to be effective against Ebola viruses because they use the same feature mimicked by NV-387. It is highly unlikely that viruses can escape NV-387, because this drug mimics the features on host cells that the viruses continue to require even as they mutate or evolve in the field.

Additionally, NV-387 Oral Gummies is a drug product readily delivered orally. It does not even require swallowing effort or water, because it dissolves in the mouth by itself, simplifying delivery for even sick individuals with swallowing difficulties.

This oral delivery is an important feature that puts NV-387, a broad-spectrum antiviral, as being superior to the other approaches.

NanoViricides has retained Om Sai Clinical Research Private Limited, India, as the CRO for the Phase II Mpox clinical trial in DRC previously. Om Sai CRO has been instrumental in putting together a team of renowned experts to lead and execute the clinical trial of NV-387 as a treatment for Ebolaviruses in DRC.

The next steps for NanoViricides will be to perform appropriate submissions to the National Ethics Committee of DRC, and upon their approval, to submit a clinical trial application to the regulatory agency, ACOREP for approval to begin the clinical trial. Most of these documents are ready because the same drug NV-387 Oral Gummies has been approved by ACOREP for a Phase II clinical trial as a Treatment for Mpox in DRC.

NV-387 Oral Gummies drug product was recently shipped to DRC for the impending Phase II clinical trial of NV-387 as a Treatment for Mpox. It will thus be immediately locally available to combat the Ebola outbreak if it shows effectiveness against Ebola Bundibugyo in patients.

While there is currently minimal risk of Ebola in the USA, the CDC’s mathematical models suggested this Central African outbreak could grow to 10,000 to 20,000 cases and 2,000 to 4,000 deaths in the next three months alone, rivaling the largest outbreak to date in 2014-2016[4].

The outbreak which was declared a Public Health Emergency of International Concern (“PHEIC”) by the WHO on May 17, 2026, continues to rapidly expand, outpacing containment efforts. The outbreak arose in a high traffic region bordering the Democratic Republic of Congo (DRC), with travel contacts to Uganda, and South Sudan and with 11 more nations in Africa at risk[5].

Infusions with a new antibody cocktail, MBP134 (ZMapp), or a monoclonal antibody, Maftivimab (Regeneron), or a nucleotide analog Remdesivir are being considered for treatment and are likely to advance into clinical trials.

NV-387 was previously found to be superior to remdesivir in a lethal animal model of a viral disease. The Company believes this superiority of NV-387 is very likely to extend to the current novel Bundibugyo ebolavirus strain.

NV-387 is a broad-spectrum antiviral that mimics the host-side feature called heparan sulfate proteoglycan that over 90-95% of human pathogenic viruses require for infecting cells. No matter how much the virus changes in the field, it continues to use HSPG, and therefore it cannot escape the drug NV-387. In contrast, Remdesivir is a small molecule inhibitor of the viral RDRP enzyme needed for making copies of the viral genome, and the virus can possibly escape by small number of mutations.

All Ebola viruses utilize HSPG as the attachment receptor, followed by entry into the cell inside endosomes. The virus substantially dismantles in the endosome and hitches a cognate receptor called NPC1 to enter the cytoplasm where the next steps in its replication begin.

Thus there is a strong rationale that NV-387 could be highly effective against Ebola virus infections, not just Bundibugyo, but also the Sudan and other viruses for which there are no treatments.

NV-387 is available as an oral medication that has excellent stability at room temperature, enabling ease of transport, distribution, and delivery to patient. NV-387 oral gummies dissolve naturally in the mouth and do not require tablet swallowing, which is difficult for children, seniors, and also patients with sore throat.

If NV-387, as a broad-spectrum antiviral, is found to be effective against the Bundibugyo virus, it will likely be effective against all ebolaviruses or all filoviruses; that would be a game changer for pandemic preparedness.

Currently there is no treatment or vaccine for the Bundibugyo virus. All previous efforts have been focused on vaccines and antibodies[6]. This has led to approval of therapies that are specific to the Zaire strain only, albeit with limited effectiveness. This leaves out all other filoviruses of consequence: Sudan, Marburg, and the more rare Bundibugyo with no treatment or vaccine.

The US Government is active in ensuring that suspected or confirmed ebolavirus cases do not enter the general population in the USA. To this end, travel from DRC has been restricted, and suspect travelers are directed to screening at specific airports and may be quarantined.

The case fatality rate of ebolaviruses has generally been around 50% in recent outbreaks, with improvements in care, including hydration therapy, corticosteroids, and other usual symptomatic treatments. Ebola viruses spread via bodily fluid secretions including fomites/sputum, as well as semen/genital secretions. Ebola virus can remain in survivors even as many as 965 days after the disease without symptoms, and can transmit through bodily secretions, suggesting possible latency. Many recent outbreaks have been ignited as a result of such reawakened-transmitted virus from a survivor. Sexual transmission was documented even as late as 482 days after disease. This persistence and possible latency of ebolavirus in immune-privileged organs (e.g. brain, eyes, gonads, where antibodies are not operative) makes it a uniquely serious threat for global transmission and sustained outbreaks.

An irony is that because of the high case fatality rate (CFR) approaching 50%, the spread of ebolavirus remains rather limited. If a variant emerges with a reduced CFR, say in the range of 5-15%, the potential threat of global pandemic from such an outbreak would increase substantially. So far, BDBV has demonstrated variable CFR ranging from under 5% (in Uganda, 2026), to around 15% (in DRC), to over 35% (some specific parts of DRC). Therefore, BDBV is particularly of greater concern as a potential pandemic disease. However, it is believed that ebolaviruses do not transmit via respiratory droplets or aerosols, and require extensive contact with bodily fluids of an infected person. Currently there is no apparent threat of a global pandemic.

With ever-increasing global travel, local outbreaks such as ebola can quickly travel far and wide potentially causing global pandemics, as was the case with COVID-19, if not caught in time. It is not feasible to produce a new vaccine and a new set of antibody drugs to combat every possible virus. Even if vaccines and antibodies are produced, the virus would escape by generating variants, as the world has witnessed during the COVID-19 pandemic.

“Only safe and effective broad-spectrum antiviral drugs that can effectively combat most viral infections will enable the world to combat viruses and defend the global population in the war against known and unknown nanoscopic enemies that are viruses,” commented Dr. Diwan, adding, “NV-387 is the only drug with such potential that is in clinical development today, to the best of our knowledge.”

ABOUT NANOVIRICIDES

NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company’s business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.

Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.

The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides’ platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company’s pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.

This press release contains forward-looking statements that reflect the Company’s current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading “Risk Factors” and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to “Investigational New Drug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to “Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency’s (EMA) committee responsible for human medicines. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
[email protected]

Public Relations Contact:
[email protected]

[1] https://www.msn.com/en-us/health/other/congos-ebola-outbreak-spreads-to-two-more-provinces/ar-AA27NkjT

[2] https://virological.org/t/initial-genomes-from-may-2026-bundibugyo-virus-disease-outbreak-in-the-democratic-republic-of-the-congo-and-uganda/1032

[3] https://www.reuters.com/business/healthcare-pharmaceuticals/trial-bundibugyo-ebola-treatment-starts-drc-who-says-2026-07-02/

[4] https://www.cdc.gov/media/releases/2026/update-on-ebola-outbreak-in-the-democratic-republic-of-the-congo-and-uganda-6-5-2026.html

[5] https://www.forbes.com/sites/maryroeloffs/2026/05/25/african-health-officials-on-ebola-this-is-too-much-live-updates/

[6] Substantial work was also performed to develop small chemical potentially broad-spectrum agents. Remdesivir was the only small chemical that entered the PALM clinical trials ca. 2018-2019 but failed to show effectiveness. Small chemicals are readily escaped by viruses often with just single mutations.

SOURCE: NanoViricides

Release – Cadrenal Therapeutics’ Late-Breaking Phase 2 Data Demonstrate Greater Than 25% Reduction in Thrombotic Events in HIT for First-in-Class 12-LOX Inhibitor CAD-1005 at ISTH 2026 Congress

Posted on by [email protected]
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Research News and Market Data on CVKD

  • Selected as one of three late-breakthrough abstracts: clinical trials and innovation in thrombosis, CAD-1005 took center stage before the global thrombosis community at the largest ISTH meeting in more than a decade.
  • Oral presentation by Principal Investigator Dr. Steven E. McKenzie highlighted CAD-1005 as the first randomized, blinded, placebo-controlled trial for Heparin-Induced Thrombocytopenia (HIT).
  • Phase 2 data demonstrate an absolute reduction of more than 25% in thrombotic events, supporting the clinical advancement of this Phase 3-ready program.
  • CAD-1005 targets a life-threatening immune-mediated clotting disorder, with an estimated $2 billion in peak annual revenue and no currently approved root-cause therapies.

PARIS, July 13, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for rare immunothrombotic conditions, announced today that late-breaking clinical data from the Phase 2 study of the first-in-class 12-lipoxygenase (12-LOX) inhibitor CAD-1005 were featured in a highly anticipated late-breaking oral presentation at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris.

This year’s ISTH Congress marked a historic milestone, bringing together clinicians, researchers, scientists, educators and industry leaders from around the world for five days of scientific discovery, collaboration and innovation in thrombosis, hemostasis and vascular biology. Drawing the largest in-person audience in more than a decade, the event attracted over 6,000 registrants and more than 3,100 abstract submissions. As the premier global gathering for cutting-edge scientific research, the ISTH late-breakthrough program is reserved for high-impact clinical trial results and first disclosures that may define future standards of care and clinical practice.

The oral presentation, titled “12-lipoxygenase inhibition with CAD-1005 (formerly known as VLX-1005) in heparin-induced thrombocytopenia,” was part of the high-profile session on clinical trials and breakthrough innovations. It marks a historic milestone as the first randomized, blinded, placebo-controlled clinical trial in patients with Heparin-Induced Thrombocytopenia (HIT).

“Targeting 12-lipoxygenase is a novel, highly selective therapeutic approach that is intended to address the root cause of immune-mediated platelet activation in HIT,” said Dr. Steven E. McKenzie. “The data we presented in Paris illustrated how CAD-1005 could fundamentally shift the treatment paradigm for acute thrombotic care. By showing an encouraging reduction in thrombotic events when added to standard anticoagulation, this therapy may offer a highly differentiated and desperately needed option for these high-risk patients. Clinicians from around the world were enthusiastic about this novel approach to a serious unmet medical need.”

Key Phase 2 Highlights Presented:

  • Addressing the Root Cause: Unlike standard-of-care anticoagulants that only reduce thrombin generation, CAD-1005 is designed to directly block the underlying 12-LOX immune signaling loop that drives antibody-mediated platelet activation.
  • Efficacy Signal: Patients treated with CAD-1005 experienced a reduction of more than 25% in new or worsening thrombotic events compared with the placebo arm (50% vs. >75%), despite the study not being sufficiently powered for statistical significance.
  • Safety Signal: No serious adverse events attributable to CAD-1005, no major bleeding in SRA+ patients, and no deaths. Treatment with CAD-1005 was associated with fewer thromboembolic events without an increase in major bleeding.
  • Paradigm Shift in Trial Design: The trial established that the traditional platelet count recovery rate is an inadequate surrogate for clinical efficacy, as thrombotic events continued to occur after recovery. This provides critical framework intelligence for Cadrenal’s upcoming pivotal Phase 3 registration trial.

“The selection of the Phase 2 study for a late-breaking presentation at ISTH underscores the scientific integrity and significant commercial potential of CAD-1005,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “With our recent financing, we are well-positioned to advance partnering opportunities for CAD-1005 and tecarfarin.”

CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) and Orphan Drug status from the European Medicines Agency (EMA).

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 in 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 in HIT. CAD-1005 is intended to be used alongside existing standards of care and is being developed to address the underlying biological mechanisms that drive disease progression. To view how CAD-1005 works in HIT, click https://vimeo.com/1209382706/7dde06dc08?share=copy&fl=sv&fe=ci

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 is the leading cause of acquired heart disease in developed countries. Tecarfarin has also received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA).

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 such as targeting 12-lipoxygenase being a novel, highly selective therapeutic approach addressing the root cause of immune-mediated platelet activation in HIT; the data presented in Paris illustrating how CAD-1005 could fundamentally shift the treatment paradigm for acute thrombotic care; the therapy offering a highly differentiated and desperately needed option for these high-risk patients; the selection of the Phase 2 study for a late-breaking presentation at ISTH underscoring the scientific integrity and significant commercial potential of CAD-1005; and the Company being well-positioned to advance partnering opportunities for CAD-1005 and tecarfarin. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to enter into a partnership opportunity for CAD-1005 and tecarfarin; the ability to benefit from the commercial potential of CAD-1005; 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]

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