Health Archives - Page 7 of 258

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

Posted on July 16, 2026July 16, 2026 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 July 15, 2026July 15, 2026 by [email protected]

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]

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 July 15, 2026July 15, 2026 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 July 15, 2026July 15, 2026 by [email protected]

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, 3^rd 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 July 14, 2026July 14, 2026 by [email protected]

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

Source: MariMed Inc.

Released July 14, 2026

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

Posted on July 14, 2026July 14, 2026 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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This 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.

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

Posted on July 14, 2026July 14, 2026 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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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

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 July 13, 2026July 13, 2026 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 July 13, 2026July 13, 2026 by [email protected]

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]

Release – Ocugen, Inc. Announces Binding Term Sheet with Roots Pharmaceutical to License OCU400 Modifier Gene Therapy for Retinitis Pigmentosa in the Middle East and North Africa

Posted on July 13, 2026July 13, 2026 by [email protected]

Research News and Market Data on OCGN

July 13, 2026

PDF Version

Cumulative sales milestones up to $255 million and modest upfront/near-term development milestones
Royalties equaling 22% of net sales
Ocugen to manufacture and supply OCU400

MALVERN, Pa., July 13, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced the signing of a binding term sheet to negotiate and enter into a license agreement with Roots Pharmaceutical, and its strategic partner Al-Dhow International Holding, for the exclusive rights to OCU400, Ocugen’s novel modifier gene therapy for Retinitis Pigmentosa (RP), in the Middle East and North Africa (MENA) region.

Pursuant to the term sheet, under the license agreement, Ocugen is expected to receive upfront license fees and near-term development milestone payments totaling up to $4 million. The Company would be entitled to sales milestone payments up to $255 million, in addition to a 22% royalty on net sales of OCU400 generated by Ocugen’s partner. Additionally, Ocugen would manufacture commercial supply of OCU400 under the terms of a related supply agreement.

RP is a leading cause of inherited vision loss globally, with notable prevalence across the MENA region, underscoring the significant unmet need OCU400 is positioned to address through this partnership.

“This step forward represents an important milestone in our effort to advance OCU400 regional partnership strategy,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “By partnering with an established leader with strong reach across the Middle East and North Africa, we are expanding our ability to bring this one-time potential treatment for life to a region where RP is highly prevalent with a significant unmet medical need where patients are desperately looking for rescue from blindness. This agreement underscores the momentum behind OCU400 and our continued commitment to patients.”

“Bringing innovative gene therapies to patients across the MENA region is a strategic imperative for Roots Pharmaceutical and its strategic partner Al-Dhow International Holding,” said Dr. Islam Zayed, CEO & Co founder of Roots Pharmaceutical. Dr.Zayed emphasized that “ OCU400 built on our legacy of bringing Rare Disease therapies to patients in MENA and enables our combined teams to decrease disease burden in the region. Importantly, Roots is dedicated to bringing OCU400 to patients with Retinitis Pigmentosa and creating a new treatment paradigm. We are excited to partner with the Ocugen team.”

Additional details will be available once the definitive agreement between the parties is executed, which is expected to occur within the next 90 days.

Ocugen continues to advance OCU400 through its Phase 3 liMeliGhT clinical development with a topline readout expected in 1Q 2027 and BLA submission to follow.

About Ocugen, Inc.
Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late-stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X and LinkedIn.

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

Investor Contact:
Candice Masse
astr partners
[email protected]

Release – Tonix Pharmaceuticals Announces Major Managed Medicare Payer Agreement for TONMYA®

Posted on July 13, 2026July 13, 2026 by [email protected]

Research News and Market Data on TNXP

July 13, 2026 7:00am EDTDownload as PDF

New agreement, effective January 1, 2027, to add approximately 9 million Medicare lives (16% of approximately 55 million Medicare lives in the U.S.)

On top of two previously announced major commercial payer agreements and Medicaid availability in most states, pharmacy coverage for TONMYA will total approximately 46% of all covered lives in the U.S.

Sales force expansion underway with additional field deployment expected by mid-third quarter 2026

BERKELEY HEIGHTS, N.J., July 13, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or “the Company”), a fully integrated, commercial-stage biotechnology company, today announced a major managed Medicare agreement for TONMYA® (cyclobenzaprine HCl sublingual tablets), adding approximately 9 million Medicare lives (16% of approximately 55 million Medicare lives in the U.S.). The new agreement will go into effect on January 1, 2027. On top of two prior commercial coverage agreements with leading group purchasing organizations (GPOs) effective in the second quarter of 2026, and Medicaid availability in most states representing approximately 73 million lives, pharmacy coverage for TONMYA on January 1, 2027, will total approximately 145 million covered lives (46% of 314 million covered lives). Discussions with other commercial and Medicare payers continue to advance.

Following these coverage milestones and positive trends across the launch’s key performance indicators, Tonix is executing its strategy to incrementally grow the TONMYA sales force and expects to deploy 50 new sales force representatives in the field by mid-third quarter 2026, bringing the full sales force to approximately 150 people.

“Patient access to TONMYA is accelerating with the new Medicare agreement on top of two previously announced commercial coverage wins in the first two full quarters of launch,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Having gained substantial patient access, we are expanding our sales force. We believe we are strongly positioned to address patients’ interest in an alternative fibromyalgia medicine and realize the significant potential of the TONMYA opportunity. TONMYA is a first-in-class, non-opioid analgesic designed for daily bedtime administration and long-term use that could serve as an important treatment option.”

Thomas Englese, MBA, Executive Vice President, Commercial Operations, added, “Our coverage growth reflects the recognition of TONMYA’s value for patients and healthcare prescribers (HCPs). Alongside this progress, we are also seeing positive signals across our launch key metrics, including new prescribers, new patients initiating treatment, total prescriptions, and refill prescriptions. By scaling our field team, we expect to engage more top-target HCPs through increased breadth and frequency. We are simultaneously expanding marketing and medical affairs activities to develop greater understanding of fibromyalgia and TONMYA among patients and HCPs. We remain focused on operational excellence and execution.”

About Fibromyalgia

Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts more than 10 million adults in the U.S., predominantly women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

About TONMYA® (cyclobenzaprine HCl sublingual tablets)

TONMYA (cyclobenzaprine HCl sublingual tablets) was approved on August 15, 2025, by the U.S. Food and Drug Administration (FDA) for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. TONMYA provides rapid transmucosal absorption of cyclobenzaprine and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypassing first-pass hepatic metabolism. TONMYA is a multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, alpha1-adrenergic, H1-histaminergic, and M1-muscarinic receptors. TONMYA was investigated as TNX-102 SL. TNX-102 SL is also being developed to treat acute stress disorder (ASD)/acute stress reaction (ASR), and major depressive disorder (MDD). The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TONMYA composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034.

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. 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.

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

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]

INDICATION
TONMYA is indicated for the treatment of fibromyalgia in adults.

CONTRAINDICATIONS
TONMYA is contraindicated:

In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.

During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism.

WARNINGS AND PRECAUTIONS
Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.

Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.

Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.

Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.

CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

DRUG INTERACTIONS
MAO inhibitors: Life-threatening interactions may occur.

Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.

USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).

Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.

Pediatric use: The safety and effectiveness of TONMYA have not been established.

Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.

Please see additional safety information in the full Prescribing Information. To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Source: Tonix Pharmaceuticals Holding Corp.

Released July 13, 2026

Release – Greenwich LifeSciences Announces European Approval for Use of Commercially Manufactured GP2 in FLAMINGO-01

Posted on July 9, 2026July 9, 2026 by [email protected]

Research News and Market Data on GLSI

Download as PDF July 09, 2026 6:00am EDT

STAFFORD, Texas, July 09, 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 use of commercially manufactured GP2 in FLAMINGO-01 in Europe.

All European and US Sites to Treat Patients with Commercially Manufactured GP2

The Company previously announced that the first three commercial lots of GP2 active ingredient were manufactured in 2023 in an approved commercial facility, which could be used to prepare approximately 200,000 doses of GP2. In 2024, the first commercial lot filling GP2 into vials for commercial sale or for clinical use was manufactured in a commercial facility. In addition, drug stability programs were initiated for all four lots. Data on these commercial lots was submitted to the FDA, and after review, the first commercial lot of GP2 vials was approved for use in FLAMINGO-01 in the US in early 2026. All approximately 40-50 US sites have been supplied with commercially manufactured GP2 vials and have begun treating patients with these vials. We were able to efficiently distribute the GP2 vials and communicate with the US pharmacists working with our warehouse partners and through our clinical team, which we internalized in Q4 2025.

The European Medicines Agency (EMA) has completed their review and will also allow use of the same commercially manufactured GP2 lot in FLAMINGO-01 in Europe. Thus, all clinical sites in the US and Europe, which have increased from 160 sites to approximately 170-180 sites, are expected to be using the same lot with shipments to European pharmacies already under way. We are now seeking approval to use this lot in the UK and Canada in separate and independent regulatory processes.

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.

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

About Breast Cancer and HER2/neu Positivity

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

About Greenwich LifeSciences, Inc.

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

Forward-Looking Statement Disclaimer

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 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]

Source: Greenwich LifeSciences, Inc.

Released July 9, 2026

MAIA Biotechnology (MAIA) – First Data From Phase 2 Part C Trial Shows Data Consistent With Earlier Studies

Posted on July 9, 2026July 9, 2026 by [email protected]

Thursday, July 09, 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.

Data From Part C Announced. MAIA announced data from Part C (Expansion stage) of its Phase 2 THIO-101 trial in non-small cell lung cancer (NSCLC). This open-label stage of the trial tests the combination of ateganosine and cemiplimab (Libtayo, from Regeneron) as a third-line (3L) therapy for patients with advanced disease that no longer respond to other therapies. The data after the first evaluation have a Disease Control Rate (DCR) of 90.5% (19 out of 21 patients), compared with published rates of 25% to 35%. We view this as a good sign that patient responses are consistent with previous data.

Design Of the Phase 2 THIO-101 Trial. The Phase 2 THIO-101 Expansion stage is the third part of the Phase 2 trial. Part A tested safety, while Part B was for dose optimization and selection. Part C is currently testing the combination of the 180 mg dose of ateganosine with cemiplimab. If positive, the data could be used to apply for accelerated approval from the FDA.

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