Category: Health

A Microcap Just Raised $200 Million to Chase a Single Drug Across Three Diseases at Once

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Processa Pharmaceuticals (Nasdaq: PCSA) announced Tuesday it has acquired clinical-stage biotechnology company Vidya Therapeutics in a stock-for-stock transaction, adding Vidya’s lead asset VT-7208 to Processa’s pipeline. Alongside the acquisition, the company secured an oversubscribed private placement expected to raise approximately $200 million in gross proceeds from a syndicate of healthcare-focused institutional investors, including Bain Capital Life Sciences, Janus Henderson Investors, and RA Capital Management.

The financing transforms the balance sheet of a company that just months ago was a small, thinly capitalized biotech. Management expects the proceeds to fund operations into the second half of 2029, well past the point where multiple clinical readouts are expected to determine whether this bet pays off.

What VT-7208 Actually Is

VT-7208 is a next-generation, CNS-penetrant, once-daily oral Bruton’s tyrosine kinase inhibitor, designed specifically to overcome the efficacy and safety limitations that have held back earlier BTK inhibitor programs. BTK is a validated node in B-cell activation, mast cell signaling, and innate immune function, which is why a single well-designed BTK inhibitor can plausibly be tested across autoimmune, allergic, and neuroinflammatory conditions rather than being confined to one narrow indication.

In a Phase 1 clinical trial, VT-7208 demonstrated robust and sustained target engagement at low milligram doses, validating the signaling pathway mechanism and supporting predictable, dose-dependent activity. The compound’s selectivity profile was also designed to minimize off-target kinase activity, which Vidya believes may reduce hepatotoxicity risk compared to earlier BTK inhibitors, a meaningful differentiator in a drug class where liver safety concerns have previously limited development.

The Strategy: Parallel Development Instead of Sequential

Rather than advancing VT-7208 in a single disease and waiting years for that program to read out before moving to the next, Processa plans to run parallel Phase 2 proof-of-concept studies simultaneously across food allergy, chronic spontaneous urticaria, and relapsing multiple sclerosis. Studies in food allergy and CSU are expected to begin in the second half of 2026, with the RMS program following in the first half of 2027. Multiple clinical milestones are anticipated over the next 12 to 24 months.

That parallel approach is precisely what the $200 million financing enables. Running three Phase 2 programs concurrently requires substantially more capital upfront than a single-indication strategy, but it compresses the overall timeline to determine whether the drug works across its full potential addressable market.

A Dramatic Recapitalization

The deal terms reveal just how significant this transaction is relative to Processa’s prior scale. Under the agreement, existing Processa shareholders are expected to own approximately 0.9% of the combined company on a fully diluted basis, while Vidya equity holders receive approximately 46% and private placement investors receive the remainder through Series A non-voting convertible preferred stock. That level of dilution reflects a company essentially being rebuilt around a single new asset, with the institutional investor syndicate effectively taking control of the capital structure in exchange for funding the buildout.

Vidya founder and Executive Chair Dr. Sheila Gujrathi will join Processa’s board following the transaction.

What It Means for Small Cap Biotech Investors

This deal is a clear example of a pattern playing out across small cap biotech in 2026: companies with promising early clinical data but insufficient capital merging into public shells or smaller Nasdaq-listed companies, then immediately recapitalizing through large institutional private placements to fund a fully resourced development plan. For investors, the scale of dilution here is real and needs to be understood clearly, but the resulting company enters a multi-year, well-funded window with three distinct shots at clinical validation from a single molecule.

Release – Ocugen Announces that the U.S. Food and Drug Administration Has Granted OCU410 Regenerative Medicine Advanced Therapy (RMAT) Designation for Treatment of Geographic Atrophy, Secondary to Dry Age-Related Macular Degeneration

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Research News and Market Data on OCGN

July 29, 2026

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  • RMAT designation is intended to help expedite development of new regenerative medicines that have potential to treat serious medical conditions with significant unmet need
  • The designation could accelerate OCU410’s regulatory path while further differentiating its one-time treatment for life approach from current therapies requiring chronic administration

MALVERN, Pa, July 29, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted RMAT designation to Ocugen’s investigational product OCU410 for the treatment of geographic atrophy (GA), secondary to dry age-related macular degeneration (dAMD).

“RMAT designation for OCU410 is a significant accomplishment that recognizes both the potential of our ‘one treatment for life’ novel gene therapy platform and the substantial unmet medical need for geographic atrophy,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “With an estimated 2 to 3 million people in the U.S. and Europe affected, a number expected to grow as the population ages, geographic atrophy is a leading cause of irreversible blindness in older adults, highlighting the urgent need for new treatment options. We look forward to continuing to work closely with the FDA to responsibly and efficiently advance the development program for patients suffering from this devastating disease.”

The RMAT designation for OCU410 was supported by Phase 2 clinical data demonstrating clinically meaningful efficacy and a favorable safety profile, with no reported serious adverse events related to drug. Based on these data, the FDA determined that OCU410 met the criteria for RMAT designation by providing preliminary clinical evidence that the therapy has the potential to address a serious condition with significant unmet medical need. This designation recognizes the promise of OCU410 as a regenerative medicine therapy and supports an expedited development pathway.

In early July 2026, Ocugen reached alignment with the FDA on the design of the OCU410 Phase 3 registrational trial, with study initiation expected in the third quarter of 2026, and a Biologics License Application (BLA) filing anticipated in 2028.

About Regenerative Medicine Advanced Therapy (RMAT) Designation
The FDA established the RMAT designation to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse, or cure serious or life-threatening diseases or conditions. RMAT designation is granted to investigational regenerative medicine therapies supported by preliminary clinical evidence indicating the potential to address unmet medical needs. Products receiving RMAT designation are eligible for all the benefits of the Fast Track and Breakthrough Therapy programs, including increased interactions with the FDA to support efficient development, eligibility for rolling BLA review, and the potential for accelerated approval and Priority Review, where appropriate.

About Dry Age-Related Macular Degeneration (dAMD) and Geographic Atrophy (GA)
Geographic atrophy is an advanced form of dAMD characterized by progressive degeneration of the macula, leading to irreversible central vision loss. Millions of patients worldwide are affected by GA, with a particularly high burden in aging populations in the United States and Europe. Despite recent approvals, treatment options remain limited and require chronic intravitreal injections, underscoring the need for innovative, durable therapies that address multiple disease mechanisms. dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula, the portion of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function, and central vision impairment. dAMD accounts for 85-90% of all AMD cases.

About OCU410
OCU410 is an investigational, subretinal injection, AAV5-based gene therapy that delivers RORA (retinoid-related orphan receptor alpha), a nuclear receptor that regulates key pathways involved in retinal homeostasis, including oxidative stress response, complement regulation, inflammation, and lipid metabolism. OCU410 is being developed as a one-time gene therapy for patients with GA secondary to dAMD. OCU410 received Advanced Therapy Medicinal Product (ATMP) classification from the European Medicines Agency.

About Ocugen, Inc.
Ocugen, Inc. is a pioneering biotechnology company developing gene therapies for blindness. The Company’s breakthrough modifier gene therapy platform has the potential to address significant unmet medical needs across large patient populations through a gene-agnostic approach. Unlike traditional gene therapies and gene-editing technologies that target a single gene mutation, Ocugen’s modifier gene therapies are designed to address the underlying disease biology by restoring balance across multiple gene networks. The Company is currently advancing programs for inherited retinal diseases and other causes of blindness that affect millions worldwide, including retinitis pigmentosa, Stargardt disease, and geographic atrophy, an advanced form of dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on LinkedIn and X.

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 strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, including the timing of enrollment and data readouts, the ability to initiate new clinical programs, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, statements regarding potential market size and commercial possibilities of Ocugen’s product candidates, 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 receipt of RMAT designation may not lead to faster development or regulatory review; 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 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 annual and quarterly 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.

Contacts

Investors:
Candice Masse
astr partners
[email protected]

Media:
Chris Clark
[email protected]

GeoVax Labs (GOVX) – GeoVax Reports 2Q26 With Clinical Study Plans Moving Forward

Posted on by [email protected]


Wednesday, July 29, 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.

GeoVax Reported 2Q26 With Updates For GEO-MVA and Oncology Programs. GeoVax reported a 2Q26 net loss of $4.4 million or $(0.97) per share, lower than our expected loss of $5.8 million. R&D expenses were lower than we projected due to strategic changes, with priority given to preparations for the upcoming Phase 3 trial of GEO-MVA in MPox and the Phase 2 trial of Gedeptin in oncology. Cash on June 30, 2026 was approximately $3.1 million.

Strategic Changes Lowered The 2Q26 Loss. As discussed in our Research Note on May 27, GeoVax will focus on GEO-MVA in infectious diseases and Gedeptin in oncology. These programs have established regulatory pathways, patient needs, and market potential.


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Release – Ocugen to Host Conference Call on Thursday, August 6 at 8:30 A.M. ET to Discuss Business Updates and Second Quarter 2026 Financial Results

Posted on by [email protected]

Research News and Market Data on OCGN

July 28, 2026

PDF Version

MALVERN, Pa., July 28, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it will host a conference call and live webcast to discuss the Company’s second quarter 2026 financial results and provide a business update at 8:30 a.m. ET on Thursday, August 6, 2026.

Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on the call using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 2222566
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available on the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a pioneering biotechnology company developing gene therapies for blindness. The Company’s breakthrough modifier gene therapy platform has the potential to address significant unmet medical needs across large patient populations through a gene-agnostic approach. Unlike traditional gene therapies and gene-editing technologies that target a single gene mutation, Ocugen’s modifier gene therapies are designed to address the underlying disease biology by restoring balance across multiple gene networks. The Company is currently advancing programs for inherited retinal diseases and other causes of blindness that affect millions worldwide, including retinitis pigmentosa, Stargardt disease, and geographic atrophy, an advanced form of dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on LinkedIn and X.

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, 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. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:

Investors:
Candice Masse
astr partners 
[email protected]

Media: 
Chris Clark 
[email protected]

Release – NanoViricides Awaits Approval from DR Congo Regulatory Agency for a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for Ebola, Financing Completed to Support the Trial

Posted on by [email protected]
NanoViricides Awaits Approval from DR Congo Regulatory Agency for a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for Ebola, Financing Completed to Support the Trial

Research News and Market Data on NNVC

Tuesday, 28 July 2026 08:30 AM

Topic: 

Company Update

SHELTON, CT / ACCESS Newswire / July 28, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”), a clinical stage leader developing antiviral drugs that viruses cannot escape, announces that it is eagerly awaiting regulatory approval to begin a Phase II Clinical Trial of NV-387 Oral Gummies, after having filed an application to the local regulatory agency ACOREP, as a Treatment for the Current Bundibugyo Ebolavirus in the Democratic Republic of Congo (DRC). The Company explains that it has already raised the financing to support this clinical trial.

“The financing we closed yesterday is sufficient to support the additional expenses from the anticipated Ebola clinical trial of NV-387 Oral Gummies,” said Anil R, Diwan, PhD, adding, “This rapidly growing Ebola outbreak requires a new orally acting drug to help patients and to control further spread from infected persons. Infusion drugs are simply not up to the task, as is well known.”

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, we believe an oral drug is a highly advantageous feature.

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

A clinical trial of Remdesivir infusion, an antibody cocktail MBP134 infusion, and MBP134 infusion plus Remdesivir infusion, has started according to the WHO, with first patient having received infusion of the antibody cocktail on July 2, 2026 1.

“Although this antiviral (Remdesivir) proved to be ineffective at targeting the Zaire Ebolavirus, there remains hope that it could have some benefit against the Bundibugyo virus, particularly if used in combination with MBP-134,” according to an article in Forbes explaining the “PARTNERS” clinical trial by the WHO organized collaboration 2. The article also notes that MBP134 contains two separate antibodies designed to, taken together, recognize multiple Ebola species.

Antibodies are highly specific to a particular strain of the virus and usually are not very effective against variants of the same virus that arise in the field.

The Company notes that 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 reasonably expected to extend to the current novel Bundibugyo ebolavirus strain.

The death toll has already risen above 1,300, with close to 3,000 confirmed cases, rising by more than 25% in just one week, and “(it) is spreading like a wildfire” 3. The largest previous West Africa Ebolavirus (Zaire) outbreak, in 2013-2016, killed more than 11,000 people out of at least 28,000 cases. The current outbreak, caused by a different, rare Bundibugyo strain of the ebolavirus, has already surpassed that outbreak in becoming the fastest growing Ebola outbreak to date, according to the WHO 4. This Ebola outbreak continues to increase in spread and is now present in five provinces in DRC. More concerning is the fact that over 80% of new cases are outside of known contact lists, leading to the projection that the extent of the outbreak is at least two times or more larger than the reported confirmed cases 5.

There is thus a tremendous urgency to validate a drug that works against this ebolavirus in short and decisive clinical trials for minimizing further spread by treating patients and for saving lives. NanoViricides CRO, in consultation with renowned scientists in DRC, has designed the Phase II clinical trial with this particular objective.

In contrast, the PARTNERS clinical trial will require over 1,000 patients to be treated and may not yield results for at least more than a year. A similar large collaborative clinical trial effort in the West Africa outbreak resulted in US FDA approval of two antibody drugs only specifically for EBOV Zaire, which are not deemed to be useful in the current outbreak without further clinical trials.

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. The rare Bundibugyo strain of Ebola virus causing the current outbreak appears to be its new variant, likely freshly introduced from some animal source 6, such as fruit bats.

A new clinical trial of an Oxford University designed Bundibugyo-specific vaccine has also started in DRC (ibid, #2).

NanoViricides has retained Om Sai Clinical Research Private Limited, India, as the CRO for this Phase II clinical trial for Ebola in DRC. Om Sai CRO has been instrumental in putting together a team with a renowned Principal Investigator and other renowned experts and with support from a well known University in the Ebola-affected region to lead and execute the clinical trial of NV-387 Oral Gummies as a Treatment for Ebolaviruses in DRC. The Principal Investigator has sent in the application for the clinical trial.

Om Sai is also the CRO leading the Company’s Phase II clinical trial of NV-387 Oral Gummies as a Treatment for Mpox in DRC.

“We believe NanoViricides is well positioned to provide an Oral Ebola treatment to save lives with our NV-387 Oral Gummies drug product that is already in place in DRC,” said Anil R. Diwan, PhD, President of the Company, adding, “This unique and revolutionary oral broad-spectrum antiviral drug deserves to be tested in a clinical trial more than any antibodies or other infusion drugs.” He further commented, “Viruses readily escape antibodies after exposure to them as we know from COVID-19. Infusions are not scalable to combat an outbreak of the size that is seen in DRC.”

Sufficient quantity of NV-387 Oral Gummies Drug Product for starting the clinical trial against Ebola is already available in DRC. This drug product was shipped to DRC for the ensuing Phase II clinical trial of NV-387 for the Treatment of Mpox and also to support a Phase II clinical trial for the Treatment of Ebola if approved by the regulatory agency.

“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 that are infusions. Thus evaluating if NV-387 treatment works is of paramount importance to combat this and future Ebola and Marburg outbreaks.”

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 host-side 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.

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 within just three months, rivaling the largest outbreak to date in 2014-2016 7. Unfortunately, the outbreak appears to be on track to realize these dire predictions.

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 8.

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 and possibly all filoviruses; that would be a game changer for pandemic preparedness.

All previous anti-Ebola efforts have been focused on vaccines and antibodies 9. This has led to approval of therapies that are specific to the Ebolavirus 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 US. To this end, travel from DRC has been restricted, with pre-travel quarantine requirements imposed, and suspect travelers are directed to screening at specific airports and may be further quarantined.

The case fatality rate of ebolaviruses has generally been approximately 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 15% (in Uganda, 2026), to almost 40% (in DRC, based on current confirmed cases and fatalities numbers, as of July 18, 2026). Therefore, BDBV is of great 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. In addition, within DRC and internationally, certain protective quarantine measures for travel from the outbreak areas have been implemented. Therefore, 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]

Source: NanoViricides, Inc.

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

2 https://www.forbes.com/sites/omerawan/2026/07/07/new-clinical-trials-offer-hope-in-the-fight-against-ebola-in-the-democratic-republic-of-congo/

3 https://www.aljazeera.com/news/2026/7/25/ebola-deaths-in-drc-surge-past-1300-as-virus-spreading-like-a-wildfire

4 https://www.aljazeera.com/news/2026/7/20/ebola-death-toll-in-drc-surges-to-at-least-930-as-outbreak-gathers-pace

https://www.aljazeera.com/news/2026/7/16/ebola-spreading-more-quickly-in-drc-while-uganda-is-close-to-being-virus-free

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

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

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

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

9 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

argenx Pays an 86% Premium for Forte Biosciences. What Made a Clinical-Stage Biotech Worth $2.2 Billion

Posted on by [email protected]

argenx (Euronext & Nasdaq: ARGX) announced Monday it has entered into a definitive agreement to acquire Forte Biosciences (Nasdaq: FBRX) for $77 per share in cash, a total equity value of approximately $2.2 billion. The price represents an 86% premium to Forte’s volume-weighted average trading price since July 9, when the company reported positive Phase 1b data in vitiligo. That is an unusually large premium even by the standards of this year’s active biotech M&A market, and it reflects just how quickly clinical data can transform a small cap company’s valuation.

The transaction is structured as a cash tender offer funded entirely from argenx’s existing cash on hand, with no financing condition attached. Closing is expected in the third quarter of 2026, subject to a majority of Forte shares being tendered and clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

From Strategic Investor to Full Acquirer

This deal did not appear out of nowhere. argenx had already made a strategic investment in Forte Biosciences prior to this announcement, giving it an early window into the company’s clinical progress before committing to a full buyout. That structure, investing first and acquiring later once the data supports it, reflects a disciplined approach that reduces risk for the acquirer while still preserving the option to move quickly once a program proves itself out.

The proof came fast. Forte’s lead asset, FB102, is a first-in-class anti-CD122 antibody that recently delivered statistically significant Phase 1b results in vitiligo, following earlier positive Phase 1b data in celiac disease reported last year, with Phase 2 celiac data expected in the second half of 2026. Those clinical readouts were the direct trigger for argenx’s decision to convert its strategic stake into a full acquisition.

Why CD122 Biology Matters

FB102’s mechanism targets pathogenic T-cell and NK-cell activity through CD122 biology, a distinct approach from the antibody mechanisms already in argenx’s portfolio, which includes efgartigimod, empasiprubart, adimanebart, and ARGX-121. Rather than duplicating existing capability, the acquisition broadens argenx’s ability to address autoimmune disease through an entirely different dimension of immune system dysfunction.

The commercial upside extends well beyond vitiligo and celiac disease. Management described FB102 as having pipeline-in-a-product potential, meaning the same molecule could eventually address multiple autoimmune conditions including alopecia areata, each representing a separate commercial opportunity from a single clinical asset. That kind of multi-indication potential is precisely what allows a clinical-stage company with no approved products to command a multibillion-dollar acquisition price.

What It Signals for Small Cap Biotech Investors

For investors tracking clinical-stage companies in the small and microcap immunology and autoimmune disease space, the Forte transaction reinforces a pattern that has defined biotech M&A throughout 2026. Large, well-capitalized immunology and oncology platforms are increasingly using strategic minority investments as a low-risk way to monitor promising early-stage science, then moving decisively to full acquisitions once clinical data de-risks the program. Statistically significant Phase 1b results, even well ahead of any approval pathway, are proving sufficient to justify premiums approaching 90% over recent trading prices.

That dynamic matters for the broader small cap biotech landscape. Companies advancing differentiated mechanisms in autoimmune disease, a therapeutic area with persistent unmet need and limited recent innovation, are demonstrating that credible early clinical validation can translate into outsized valuation outcomes well before a drug ever reaches the market. The Forte deal is the latest evidence that the current biotech M&A cycle rewards genuine scientific differentiation over scale.

Release – NanoViricides Announces Pricing of ~$3.8 Million Registered Direct Offering

Posted on by [email protected]
NanoViricides Announces Pricing of ~$3.8 Million Registered Direct Offering

Research News and Market Data on NNVC

Friday, 24 July 2026 08:00 AM

SHELTON, CT / ACCESS Newswire / July 24, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (“NanoViricides” or the “Company”), a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses and their variants cannot escape, today announced it has entered into a securities purchase agreement with a single fundamental institutional investor for the purchase and sale of 2,516,339 shares of common stock (or pre-funded warrants in lieu thereof), together with accompanying warrants to purchase 2,516,339 shares of common stock for gross proceeds of approximately US$3.8 million in a registered direct offering (the “Offering”). The common shares are being sold in combination with an accompanying full warrant (with each whole warrant being exercisable into one common share of the Company). Each whole warrant has an exercise price of US$1.75 per share and will expire five and half years from the date of issuance.

D. Boral Capital LLC is acting as the exclusive placement agent for the Offering.

The closing of the Offering is expected to occur on or about July 27, 2026, subject to the satisfaction of customary closing conditions. The Company expects to receive aggregate gross proceeds of ~$3.8 million from the Offering, before deducting placement agent fees and other related expenses.

The ordinary shares (or pre-funded warrants in lieu thereof) are being offered by the Company pursuant to an effective shelf registration statement on Form S-3 (Registration No. 333-296790), which was declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on June 15, 2026.

A prospectus supplement describing the terms of the proposed registered direct offering will be filed with the SEC. Once filed, it will be available on the SEC’s website at http://www.sec.gov and on the Company’s website at https://www.nanoviricides.com/. A copy of the prospectus supplement and accompanying base prospectus relating to the offering may be obtained, when available, from D. Boral Capital LLC, 590 Madison Avenue, 39th Floor, New York, NY 10022, or by telephone at (212) 404-7002, or by email at [email protected].

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

About NanoViricides

NanoViricides, Inc., is a publicly traded company (NYSE American:NNVC) (the “Company”), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses and their variants cannot escape. Its clinical stage, broad-spectrum, antiviral drug NV-387 has been granted an “Orphan Drug Designation” (ODD) by the US FDA Office of Orphan Products Development (OOPD). This could provide 7 years market exclusivity, tax credits for clinical trial costs, and fee exemptions upon approval. NV-387 is a revolutionary antiviral that we believe will be the drug offered at “first visit” when the patient presents to a doctor with any respiratory viral illness. NV-387 was also found to be highly effective in lethal animal infection models of Influenza, RSV, Coronaviruses, Monkeypox, Smallpox, and Measles.

Forward-Looking Statements

Statements made in this press release include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by the use of words such as “may,” “will,” “plan,” “should,” “expect,” “anticipate,” “estimate,” “continue,” or comparable terminology. Such forward-looking statements are inherently subject to certain risks, trends, and uncertainties, many of which the Company cannot predict with accuracy and some of which the Company might not even anticipate and involve factors that may cause actual results to differ materially from those projected or suggested. These risks include, but are not limited to, the ability to complete the offering on the terms described or at all, the ability to satisfy customary closing conditions, market conditions, regulatory developments affecting the digital asset and stablecoin industries, and other risks described in the Company’s filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements and are advised to consider the factors listed above together with the additional factors under the heading “Risk Factors” in the Company’s Annual Reports on Form 20-F, as may be supplemented or amended by the Company’s Reports of a Foreign Private Issuer on Form 6-K. The Company assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information, or otherwise.

Contacts:

For Inquiries, Contact:
NanoViricides, Inc.
[email protected]

Public Relations Contact:
[email protected]

SOURCE: NanoViricides

Cadrenal Therapeutics (CVKD) – Strategic Changes Create A New Cardiac Acute Critical Care Franchise

Posted on by [email protected]


Thursday, July 23, 2026

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

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

Advancing Products Through Partnerships. Cadrenal announced that it has modified its development strategy and product pipeline to focus on therapies for cardiac surgical care and orphan cardiac conditions. It now plans to advance the products through development partnerships, licensing, and commercialization agreements to minimize capital expenditures. This announcement formalizes the transition we have seen over the past several months.

Building A “Cardiac Acute Critical Care Franchise”. Cadrenal has refined its clinical focus to late-stage critical-care cardiovascular products for conditions with no effective treatments. It now plans to form partnerships for CAD-1005, frunexian, and tecarfarin, avoiding the large capital raises needed to fund further clinical trials.


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Release – NeuroSense Advances PrimeC Toward New Drug Submission to Health Canada for ALS

Posted on by [email protected]

Research News and Market Data on NRSN

The planned submission follows alignment with Health Canada on the NDS pathway and is supported by additional PARADIGM data, including a survival benefit and consistent effects across PrimeC’s multi-pathway biomarker program

CAMBRIDGE, Mass., July 22, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced it intends to proceed with the filing of a New Drug Submission (NDS) to Health Canada (the “Agency”) for PrimeC for the treatment of amyotrophic lateral sclerosis (ALS), following a constructive Pre-New Drug Submission (“Pre-NDS”) meeting with the Agency. NeuroSense expects to complete and file the submission in the coming months.

    The recent Pre-NDS meeting was held following the generation of substantial additional evidence from the Phase 2b PARADIGM clinical program. NeuroSense presented Health Canada with a comprehensive update to its proposed NDS package, including achievement of the study’s prespecified primary TDP-43 biomarker endpoint (p=0.0421), long-term survival (14.9-month median survival benefit, HR 0.35 and p=0.0037), external natural history analyses, and additional mechanistic and translational data generated since the Company’s initial regulatory interaction. The meeting also included an expert clinical perspective from a leading Canadian ALS specialist, as well as additional supportive analyses that will form part of the planned NDS package, further strengthening the growing body of evidence supporting PrimeC’s potential in ALS.

    “This marks an important milestone in our regulatory strategy for PrimeC,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “The additional evidence generated through the PARADIGM program – from achievement of the primary TDP-43 biomarker endpoint to the meaningful long-term survival outcome – has significantly strengthened our planned submission package and reinforces our confidence in PrimeC’s potential to address the substantial unmet need faced by people living with ALS. We appreciate Health Canada’s constructive engagement throughout the Pre-NDS process and look forward to completing our submission.”

    NeuroSense plans to continue to work with Health Canada as it prepares the NDS filing, and looks forward to providing further updates as the submission advances.

    About NeuroSense

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

    NeuroSense has recently completed analysis of long-term follow-up data from its Phase 2b PARADIGM study in ALS, supporting meaningful slowing of disease progression. The Company also reported significant biological activity across multiple biomarkers associated with ALS, including microRNAs, supporting PrimeC’s multi-target mechanism of action. and representing a potentially important advance in the treatment of ALS.

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

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

    About PrimeC

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

    About ALS

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

    Forward-Looking Statements

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

    Logo: https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg

    SOURCE NeuroSense

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

    Release – Greenwich LifeSciences Announces Approval to Expand FLAMINGO-01 into the United Kingdom

    Posted on by [email protected]
    Greenwich LifeSciences

    Research News and Market Data on GLSI

     Download as PDF

    July 22, 2026 6:00am EDT

    STAFFORD, Texas, July 22, 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 announced the regulatory approval to expand FLAMINGO-01 into the United Kingdom.

    The Company’s application to expand FLAMINGO-01 into the UK has been formally approved by UK regulators, thus adding potentially 5-10 geographically distributed UK sites to the approximately 170-180 approved sites in the US and Europe.

    The Company is collaborating with The Royal Marsden, a leading cancer research institute. Working with The Royal Marsden, we have been in discussions with many academic sites located in the following cities: London (multiple sites), Cambridge, Edinburgh, Oxford, Manchester, Southhampton, Cardiff, and potentially other cities. With regulatory approval, these start-up discussions will now move forward. The principal investigator at Royal Marsden, who will be serving as the UK national principal investigator, also plans to join the Steering Committee.

    CEO Snehal Patel commented, “We are very excited to be adding these UK sites from prominent research institutions. The initial introduction was driven by patient interest in the UK. Our hard work with The Royal Marsden in submitting our regulatory application has now paid off with our regulatory approval. The UK population of 70 million is one of the largest populations in Europe and we look forward to offering participation in FLAMINGO-01 to these patients.”

    The Royal Marsden opened in 1851 as the world’s first hospital dedicated to cancer diagnosis, treatment, research and education. Today it operates as a specialist cancer centre. Together with its principal academic partner, The Institute of Cancer Research, London, The Royal Marsden is designated as the UK’s only National Institute for Health and Care Research (NIHR) Biomedical Research Centre (BRC) dedicated solely to cancer. The Royal Marsden and The Institute of Cancer Research (ICR) are recognised as one of the top four comprehensive cancer centres in the world for the impact of their research, influencing cancer treatment and care for all cancer patients. As a centre of excellence, they pioneer the very latest in cancer treatments and technologies, as well as leading the way in innovative cancer diagnosis and education.

    Based on 2019 and 2021-2022 data from Cancer Research UK, there are approximately 59,400 new breast cancer cases in the UK every year. Breast cancer is the most common cancer in females, which is 30% of all new female cancer cases.

    About FLAMINGO-01 Open Label Phase III Data

    More than 1,500 patients have been screened at a screen rate of approximately 600-800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

    • In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
    • The non-HLA-A*02 arm is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
    • The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study. 
      • The AACR Meeting 2026 delayed-type-hypersensitivity (DTH) poster and the ASCO Meeting 2026 injection site reaction (ISR) poster can be seen and downloaded at the bottom of the Phase III clinical trial tab on the Company’s website here.
      • As shown in both posters the frequency of DTH and ISR reactions increased statistically significantly over time.
      • As reported in Table 1 of each poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline.
      • Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated.

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

    About GLSI-100 Phase IIb Study

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

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

    About FLAMINGO-01 and GLSI-100

    FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 170-180 sites globally.

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

    About Breast Cancer and HER2/neu Positivity

    One in eight U.S. women will develop invasive breast cancer over her lifetime. In the US and Europe, there are approximately 700,000 new breast cancer patients per year and 9.5 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

    About Greenwich LifeSciences, Inc.

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

    Forward-Looking Statement Disclaimer

    Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.

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

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

    Primary Logo

    Source: Greenwich LifeSciences, Inc.

    Released July 22, 2026

    Repligen Pays $1.5 Billion for BioLife Solutions to Lock In Recurring Revenue in the Cell Therapy Boom

    Posted on by [email protected]

    The life sciences tools sector produced another significant consolidation this week. Repligen Corporation (Nasdaq: RGEN), a bioprocessing technology company, announced Wednesday it has entered into a definitive agreement to acquire BioLife Solutions (Nasdaq: BLFS), a leading supplier of cell processing tools for the cell and gene therapy market, in a deal valued at approximately $1.5 billion in total enterprise value. The boards of both companies unanimously approved the transaction.

    Under the terms of the agreement, BioLife stockholders will receive $11.25 per share in cash and 0.1442 shares of Repligen common stock, together valued at $31.00 per share. The consideration mix is roughly 64% stock and 36% cash, representing a 24% premium to BioLife’s 90-day volume-weighted average price. The deal is expected to close in the fourth quarter of 2026, pending regulatory approvals and BioLife shareholder approval.

    What Makes BioLife Valuable

    BioLife’s core franchise is biopreservation media, the specialized solutions used to protect the health and function of biologic materials during collection, processing, storage, and distribution. Its lead product line, CryoStor, currently supports 18 commercially approved cell and gene therapies and is used in the majority of U.S. commercially sponsored cell-based therapy clinical trials. That kind of deep embedding in active clinical and commercial workflows is precisely what makes the business attractive to a strategic acquirer.

    The revenue profile reinforces the thesis. BioLife reported preliminary second quarter revenue of $28.5 million, up 21% year over year, a growth rate well above what most established life sciences tools companies are currently posting. Repligen, for its part, reported preliminary second quarter revenue growth of approximately 12% as reported and 13% on an organic basis, giving the combined company a meaningfully accelerated top-line growth profile once the two businesses are integrated.

    The Financial Case for the Deal

    Repligen expects the acquisition to be accretive to top-line growth, adjusted margins, and adjusted earnings per share by at least 5 cents in year one and at least 25 cents in year two. Management is targeting at least $20 million in synergies in the first year and at least $30 million in the second, driven by the elimination of public company costs, general and administrative efficiencies, and manufacturing and supply chain optimization. Notably, those projections assume only modest revenue synergies from cross-selling, leaving room for additional upside if the combined commercial teams execute well.

    The deal is structured conservatively from a balance sheet perspective. Repligen expects to fund the cash portion entirely from cash on hand and still maintain more than $300 million in pro forma cash and cash equivalents after closing, preserving flexibility for future acquisitions or other investments.

    Why Cell Therapy Consolidation Is Accelerating

    Cell therapy represents one of the fastest-growing segments of the global pharmaceutical pipeline, with commercial revenues in the space projected to grow more than 20% annually through the end of the decade. That growth rate has made the tools and consumables companies supporting cell therapy manufacturing, storage, and logistics increasingly attractive acquisition targets for larger life sciences platforms looking to embed themselves deeper into high-growth, high-margin recurring revenue streams.

    For investors tracking the life sciences tools and diagnostics space in the small and microcap range, the Repligen-BioLife transaction reinforces a consolidation pattern playing out across the sector. Companies with differentiated, deeply embedded consumables businesses tied to active clinical pipelines are commanding premium valuations, particularly when that embedding creates durable, recurring revenue rather than one-time equipment sales. The growth of the underlying cell and gene therapy market itself is worth watching closely, with companies like Ocugen advancing gene therapy programs that depend on exactly the kind of specialized processing and preservation infrastructure BioLife provides. As the cell and gene therapy pipeline continues to mature toward commercial approval, the tools companies positioned earliest in that workflow are likely to remain prime targets for strategic buyers with the balance sheet capacity to act.

    Release – GeoVax Highlights Strategic Alignment of GEO-MVA with HHS/ASPR’s Five-Year Medical Countermeasure Preparedness Strategy

    Posted on by [email protected]

    Research News and Market Data on GOVX

    ASPR Report Reinforces National Priorities for Domestic Manufacturing, Platform Technologies, Strategic National Stockpile Modernization, and Pandemic Preparedness

    ATLANTA, GA – July 21, 2026  – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing next-generation vaccines and immunotherapies, today highlighted the strong alignment between its GEO-MVA vaccine platform strategy and the priorities outlined in the U.S. Department of Health and Human Services Administration for Strategic Preparedness and Response’s (ASPR) newly released Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Multiyear Budget: Fiscal Years 2025–2029.

    The report provides the federal government’s five-year roadmap for investments in medical countermeasures, advanced manufacturing, Strategic National Stockpile (SNS) modernization, and preparedness against emerging infectious disease and biological threats.

    According to the report, approximately 65% of future medical countermeasure investment is expected to focus on threat-agnostic and multi-threat technologies, while emphasizing domestic manufacturing capability, scalable vaccine platforms, and sustained preparedness infrastructure. The report also projects a total five-year medical countermeasure investment need of approximately $66.9 billion, underscoring the growing strategic importance of resilient domestic biodefense capabilities.

    “The release of ASPR’s five-year preparedness strategy reinforces many of the strategic priorities that have guided our GEO-MVA program,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “The report recognizes that future preparedness requires more than individual vaccines – it requires flexible platform technologies, domestic manufacturing capability, resilient supply chains, and sustainable medical countermeasure infrastructure. GEO-MVA has been developed with these national priorities in mind.”

    ASPR Priorities Closely Align with the GEO-MVA Strategy

    GeoVax believes several priorities identified in the ASPR strategy directly support the long-term strategic rationale underlying the GEO-MVA program.

    Domestic Manufacturing

    The ASPR report identifies sustaining and expanding domestic commercial manufacturing capability as one of the nation’s principal preparedness challenges.

    GeoVax’s GEO-MVA program is designed to establish a U.S.-based source of Modified Vaccinia Ankara (MVA) vaccine manufacturing, supporting domestic supply-chain resilience while reducing dependence on limited global manufacturing capacity.

    Platform Technologies

    The report emphasizes investments in threat-agnostic and multi-threat technologies capable of responding rapidly to future public health emergencies.

    The MVA vector represents a well-established vaccine platform with demonstrated applicability across multiple infectious disease targets, providing flexibility beyond any single indication.

    Strategic National Stockpile

    The ASPR strategy calls for continued modernization of the Strategic National Stockpile while addressing lifecycle management, replenishment, and transition of new medical countermeasures into long-term preparedness programs.

    GeoVax believes the GEO-MVA program aligns with these objectives by supporting future U.S. preparedness capacity for orthopoxvirus threats.

    Emerging Infectious Diseases

    The report identifies emerging infectious diseases as among the nation’s highest preparedness priorities while emphasizing investments that enable rapid response to evolving threats.

    GeoVax’s clinical development strategy for GEO-MVA is intended to support preparedness against mpox and smallpox while leveraging the broader capabilities of the MVA platform.

    Independent Validation of Long-Term Preparedness Trends

    The ASPR report reflects a continuing evolution in federal preparedness strategy – from investing primarily in individual products toward investing in strategic capabilities, including manufacturing infrastructure, platform technologies, and sustainable preparedness systems.

    GeoVax believes these evolving priorities reinforce the long-term strategic value of domestic vaccine manufacturing capabilities that can support future public health emergency response.

    “Preparedness is increasingly being viewed as a strategic national capability rather than simply a collection of products,” added Mr. Dodd. “We believe this evolution supports the importance of maintaining flexible vaccine platforms and domestic manufacturing infrastructure capable of responding to future biological threats.”

    About GEO-MVA

    GEO-MVA is GeoVax’s Modified Vaccinia Ankara (MVA) vaccine candidate being developed to support protection against mpox and smallpox. The program is advancing through an immunobridging regulatory strategy following positive Scientific Advice from the European Medicines Agency (EMA) and is intended to provide an additional source of MVA vaccine manufacturing capacity supporting future public health preparedness initiatives.

    About GeoVax

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

    Forward-Looking Statements

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

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

    Company Contact:

    [email protected]

    678-384-7220

    Media Contact:

    Jessica Starman

    [email protected] 

    Cadrenal Therapeutics Launches Partnering Process as Its Cardiac Acute Critical Care Assets Advance to Transaction Readiness Following Landmark ISTH Data Presentation

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

    • Capital-efficient strategy focuses on differentiated therapies for cardiac pre- and post-operative critical care and orphan cardiovascular conditions
    • Company is exploring development, licensing, and commercialization partnerships for CAD-1005, frunexian, and tecarfarin
    • Recently presented Phase 2 CAD-1005 data demonstrated a >25% absolute reduction in thrombotic events in patients with heparin-induced thrombocytopenia

    PONTE VEDRA, Fla., July 21, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions, today announced a comprehensive alignment of its clinical portfolio into a Cardiac Acute Critical Care Franchise. Concurrently, the Company has initiated a structured process to secure strategic out-licensing, portfolio monetization, or commercial co-development partnerships for its late-stage assets.

    Cadrenal has assembled multiple late-stage critical care cardiovascular assets designed to address serious conditions for which existing treatment options remain inadequate. This capital-efficient operational model addresses a large, unserved therapeutic whitespace, unlocking substantial cumulative platform potential. The strategy positions Cadrenal’s assets as high-value additions which may be capable of delivering immediate value to the pipelines of global companies across rare disease therapies, critical care cardiology, and cardiac intensive care unit (CICU) medical products.

    The strategic alignment of the Cardiac Acute Critical Care Franchise organizes Cadrenal’s portfolio into three high-value commercial pillars:

    • Pillar 1: Pre-Operative Safety (Frunexian IV): An IV Factor XIa inhibitor for heparin-induced thrombocytopenia (HIT)-susceptible patients undergoing coronary artery bypass graft (CABG) surgery, designed to replace unpredictable alternative protocols. Phase 2-ready.
    • Pillar 2: Orphan Regulatory Acceleration (including Tecarfarin for Kawasaki Disease): Leveraging substantial commercial tailwinds, fee waivers, and potential seven-year market exclusivity associated with the potential Orphan Drug Designation (ODD) pathways for cardiac surgery patients. Phase 3-ready.
    • Pillar 3: Post-Operative Shield (CAD-1005): A Phase 3-ready IV 12-LOX inhibitor designed to target platelet hyperactivation and thrombotic risk in patients with post-operative Heparin-Induced Thrombocytopenia (HIT). Secondary benefits may include blocking the inflammatory 12-HETE cascade to reduce cardiac surgery-associated acute kidney injury (CSA-AKI).

    This franchise framework is strongly supported by the impressive clinical data presented earlier this month at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris. The late-breaking Phase 2 data for CAD-1005 demonstrated a compelling medical profile, with a greater than 25% absolute reduction in thrombotic events and a favorable safety and renal-protective baseline.

    “Our landmark clinical data presentation at ISTH 2026 has validated the mechanisms and the immense medical value of our Cardiac Acute Critical Care Franchise,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “By organizing our pipeline into three distinct commercial pillars, we are positioning Cadrenal to maximize asset value. Transitioning to a partnership-driven business model enables us to map a direct, efficient path to commercialization alongside global industry leaders.”

    In tandem with this strategic focus, the Company is advancing updates to its clinical pipeline for tecarfarin, highlighting its distinct carboxylesterase-1 (CES-1)-mediated metabolism, which helps avoid dangerous drug-drug interactions. This includes expanding clinical protocols to rare pediatric disease indications, such as giant coronary artery aneurysms (CAAs) caused by Kawasaki Disease-potentially qualifying the asset for a high-value, open-market Priority Review Voucher (PRV)-while continuing to support established indications in End-Stage Kidney Disease (ESKD) and Left Ventricular Assist Devices (LVADs).

    Standalone Platform Expansion: Oral 12-LOX (CAD-2000)

    Beyond the Cardiac Acute Critical Care Franchise, Cadrenal is advancing its preclinical platform asset, CAD-2000, a highly selective, orally bioavailable 12-lipoxygenase (12-LOX) inhibitor designed to treat chronic cardiorenal inflammatory and thrombotic indications. CAD-2000 serves as a potent oral follow-on companion to the Company’s IV acute care platform, potentially enabling prospective partners to capture extended market share across both acute inpatient settings and chronic outpatient follow-up care.

    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. 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. To view how CAD-1005 is intended to work in patients with 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 specialized therapies for critical care cardiology and orphan cardiovascular 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. The Company’s Cardiac Acute Critical Care Franchise also includes frunexian, an investigational intravenous Factor XIa inhibitor designed to provide anticoagulation for patients undergoing major cardiac surgery.

    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 under 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 Cadrenal launching a partnering process; advancing its Cardiac Acute Critical Care Assets to transaction readiness following landmark ISTH data presentation; the Company’s capital-efficient strategy focusing on differentiated therapies for cardiac pre- and post-operative critical care and orphan cardiovascular conditions; the Company exploring development, licensing, and commercialization partnerships for CAD-1005, frunexian, and tecarfarin; the Company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions; the Company securing strategic out-licensing, portfolio monetization, or commercial co-development partnerships for its late-stage assets; Cadrenal’s multiple late-stage critical care cardiovascular assets addressing serious conditions for which existing treatment options remain inadequate; the capital-efficient operational model addressing a large, unserved therapeutic whitespace, unlocking substantial cumulative platform potential; Cadrenal’s assets delivering immediate value to the pipelines of global companies across rare disease therapies, critical care cardiology, and cardiac intensive care unit (CICU) medical products; frunexian IV successfully replacing unpredictable alternative protocols; the potential of CAD-1005 to block the inflammatory 12-HETE cascade to reduce cardiac surgery-associated acute kidney injury; positioning Cadrenal to maximize asset value; transitioning to a partnership-driven business model enabling the Company to map a direct, efficient path to commercialization alongside global industry leaders; the Company advancing updates to its clinical pipeline for tecarfarin, highlighting its distinct carboxylesterase-1 (CES-1)-mediated metabolism, which helps avoid dangerous drug-drug interactions; expanding clinical protocols to rare pediatric disease indications, such as giant coronary artery aneurysms (CAAs) caused by Kawasaki Disease-potentially qualifying the asset for a high-value, open-market Priority Review Voucher (PRV)-while continuing to support established indications in End-Stage Kidney Disease (ESKD) and Left Ventricular Assist Devices (LVADs); Cadrenal advancing its preclinical platform asset, CAD-2000, a highly selective, orally bioavailable 12-lipoxygenase (12-LOX) inhibitor designed to treat chronic cardiorenal inflammatory and thrombotic indications. CAD-2000 serves as a potent oral follow-on companion to the Company’s IV acute care platform, potentially enabling prospective partners to capture extended market share across both acute inpatient settings and chronic outpatient follow-up care; tecarfarin potentially treating patients with Kawasaki disease (KD). 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, development, licensing and commercialization for CAD-1005 frunexian, and tecarfarin; the ability of Cadrenal’s assets to be additions to the pipelines of global companies across rare disease therapies, critical care cardiology, and cardiac intensive care unit medical products; the ability to benefit from the commercial potential of the Cadrenal’s product candidates; the ability to raise sufficient capital to continue the clinical development of its product candidates; 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]