Category: Health

Eledon Pharmaceuticals (ELDN) – Clinical Milestones For Tegoprubart Trials In 2H26 Reiterated

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Friday, September 04, 2026

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

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Eledon Reiterated Plans For Tegoprubart Trials In Kidney Transplantation and Diabetes. Eledon has confirmed plans to initiate its Phase 3 LEGACY trial, testing tegoprubart to prevent rejection after kidney transplants. The trial will have two arms, comparing an immuno- suppressive regimen with tegoprubart to a regimen with tacrolimus. Each arm has a target enrollment of about 300 patients at clinical sites worldwide. The primary endpoint will be a composite of BRAR, graft loss, and death. Secondary endpoints include measures of kidney function and side effects associated with tacrolimus.

IND For Islet Cell Transplantation In Diabetes Has Been Filed. The company has submitted an IND (Investigational New Drug) application to begin testing tegoprubart to prevent rejection of islet cell allograft transplants in type 1 diabetes (T1D). To date, 12 patients treated in the first trial have achieved cell engraftment and normalized blood glucose. Their recent HbA1c levels averaged 5.4%, comfortably below the standard 6.5% threshold for diabetes. The upcoming trial will be multicenter and intended to meet requirements for FDA approval.


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Release – Eledon Pharmaceuticals Announces Islet Cell Transplantation IND Submission, First Patients Enrolled in Multiple Transplant Programs, and Reaffirms Plan to Initiate Phase 3 Kidney Transplantation Trial in Fourth Quarter 2026

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eledon logo

Research News and Market Data on ELDN

September 3, 2026

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IND submitted to FDA for Eledon-sponsored, registrational study of tegoprubart in islet cell transplantation for patients with type 1 diabetes

First patients enrolled in new investigator-initiated study of tegoprubart in patients with renal dysfunction receiving an islet cell transplant

First patient dosed under compassionate use of tegoprubart for conversion from tacrolimus in islet cell transplant recipients with calcineurin inhibitor related kidney dysfunction

First patients dosed under compassionate use of tegoprubart in highly sensitized patients with pre-existing antibodies receiving a kidney transplant

Company on track to initiate global Phase 3 LEGACY trial of tegoprubart in kidney transplantation in Q4 2026

IRVINE, Calif., Sept. 03, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced significant progress across multiple tegoprubart development programs in kidney allotransplantation and islet cell transplantation. The Company also reaffirmed that it remains on track to initiate LEGACY, its global Phase 3 clinical trial evaluating its investigational novel immunosuppression therapy tegoprubart, an anti-CD40L antibody, in patients undergoing kidney transplantation, in the fourth quarter of 2026.

“The progress announced today reflects the growing breadth and momentum of tegoprubart’s clinical development across multiple transplant settings as we work to redefine transplant immunomodulation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We remain on track to initiate our global Phase 3 LEGACY trial in kidney transplantation in the fourth quarter of 2026, while the submission of an IND for our first Company-sponsored islet cell transplantation study represents an important regulatory milestone for the tegoprubart program. In parallel, investigator-initiated studies and compassionate-use experience are expanding the clinical evaluation of tegoprubart into transplant populations with significant unmet needs, including in patients experiencing calcineurin inhibitor-related toxicities and in highly sensitized kidney transplant recipients who face elevated immunologic risk. These new programs are expected to generate important clinical insights and data updates over the next 12 months.”

Islet Cell Transplantation

  • IND submitted for Eledon-sponsored islet cell transplantation study in type 1 diabetes. Eledon has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a planned Company-sponsored, registrational clinical trial evaluating tegoprubart for the prevention of allograft rejection in type 1 diabetes (T1D) patients undergoing pancreatic islet cell transplantation. The planned study would be Eledon’s first Company-sponsored clinical trial in islet cell transplantation and represents an important step in the Company’s registrational pathway for tegoprubart in this patient population.
  • First patients enrolled in a new investigator-initiated study involving islet cell transplant recipients with T1D and chronic kidney disease. The first patients have been enrolled in an investigator-initiated clinical trial evaluating tegoprubart for the prevention of allograft rejection in patients with T1D and renal dysfunction from chronic kidney disease receiving an islet cell transplant. The study, underway at the University of Chicago Medicine Transplant Institute, evaluates a calcineurin inhibitor–free, tegoprubart-based immunosuppression regimen in patients who are especially susceptible to tacrolimus toxicity, including kidney damage, which has long constrained the use of islet cell transplantation.
  • First islet cell transplant recipient dosed with tegoprubart following conversion from tacrolimus. The first islet cell transplant recipient has been dosed with tegoprubart under a compassionate-use protocol allowing them to switch from their previous tacrolimus-based immunosuppression therapy due to calcineurin inhibitor–related renal dysfunction. This compassionate use of tegoprubart may address an important unmet need among transplant recipients who require lifelong immunosuppression therapy to preserve graft function but experience renal complications often associated with calcineurin inhibitors such as tacrolimus, today’s standard of care.
  • Ongoing UChicago Medicine investigator-initiated study in participants with T1D undergoing islet cell transplantation expanded by three patients. UChicago Medicine is adding three additional patients in its ongoing investigator-initiated islet cell transplantation study evaluating tegoprubart as the core immunosuppressant, expanding the study beyond the 12 patients treated to date. This enrollment expansion builds on previously reported results in which all 12 patients with T1D achieved insulin independence, producing their own insulin and no longer requiring exogenous insulin therapy to manage their disease, and a hemoglobin A1c (HbA1c) level below 7.0% following islet cell transplantation and treatment with tegoprubart. Stable islet graft function was observed across all 12 study participants through a maximum reported follow-up of 22 months. Tegoprubart demonstrated a favorable tolerability profile, with no evidence of nephrotoxicity, hypertension, or neurotoxicity, which are side effects often associated with calcineurin inhibitors such as tacrolimus.

Kidney Transplantation

  • Phase 3 LEGACY clinical trial on track to initiate in Q4 2026. Following its successful End-of-Phase 2 meeting with the FDA, Eledon remains on track to initiate its global Phase 3 trial of tegoprubart in kidney transplantation (LEGACY) in the fourth quarter of 2026. The LEGACY trial is expected to enroll approximately 600 patients, with a primary endpoint of non-inferiority versus tacrolimus at 52 weeks based on a composite of biopsy-proven acute rejection (BPAR), graft loss, and death.
  • First highly sensitized kidney transplant patient dosed under compassionate use. The first highly sensitized kidney transplant patient has been dosed with tegoprubart under a compassionate-use protocol at Duke University Medical Center. Highly sensitized patients requiring a kidney transplant face a substantial unmet need because pre-existing antibodies can significantly limit access to compatible donor organs and increase the risk of antibody-mediated rejection and graft loss post-transplant. The compassionate use of tegoprubart in this setting will help expand our clinical insights and understanding of tegoprubart’s potential in a particularly challenging patient population.
  • Third patient treated in investigator-initiated kidney transplant tolerance study. A third patient has been treated in the investigator-initiated study evaluating tegoprubart for kidney transplant tolerance induction at Massachusetts General Hospital (MGH). Tolerance induction has the potential to eliminate the need for patients to require lifelong immunosuppression therapy.

About Eledon Pharmaceuticals and tegoprubart

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

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

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

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

Eli Lilly Pays Up to $2.9 Billion for a Biotech That Deletes the Antibodies Making People Sick

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Eli Lilly (NYSE: LLY) announced Monday it has agreed to acquire privately held Merida Biosciences in an all-cash deal worth up to $2.875 billion, adding a genuinely distinct approach to autoimmune and allergic disease treatment to its growing immunology pipeline. The transaction includes an upfront cash payment plus additional milestone payments tied to future development and regulatory progress, though Lilly has not disclosed the specific breakdown between the two. The deal is expected to close in the fourth quarter of 2026, subject to regulatory approval.

What makes Merida’s science genuinely interesting is the mechanism itself. Most existing treatments for autoimmune conditions work by broadly suppressing the immune system, which can control symptoms but often leaves patients more vulnerable to infection and other side effects. Merida is developing biologics engineered to do something more precise, selectively identifying and eliminating the specific malfunctioning antibodies, known as autoantibodies, that are actually causing a given disease, while leaving the rest of the immune system intact.

That broader shift toward precision, antibody-targeted immunology is playing out across the sector, not just at Lilly. Smaller clinical-stage companies like Eledon Pharmaceuticals are pursuing a related but distinct approach, targeting the CD40L signaling pathway that drives the immune system’s production of pathogenic antibodies in the first place, rather than eliminating those antibodies after they’ve formed. Eledon’s lead candidate is currently in development for organ transplant rejection and other immune-mediated conditions, illustrating how the industry is converging on more targeted immune intervention from multiple different angles simultaneously.

The company’s lead program, MER511, is currently in Phase 1 development for Graves’ disease and thyroid eye disease, two related conditions caused by autoantibodies that overactivate the thyroid-stimulating hormone receptor. Graves’ disease affects an estimated 3 million people in the United States alone, causing an overactive thyroid, while thyroid eye disease can lead to inflammation, eye bulging, double vision, and in severe cases, permanent vision impairment. Early data has reportedly shown the drug substantially lowering the specific antibodies driving both conditions, alongside a favorable initial safety profile.

Beyond its lead asset, Merida’s pipeline includes MER769, an earlier-stage program targeting the antibody responsible for food allergy, asthma, and chronic spontaneous urticaria, along with additional early research in kidney conditions such as membranous nephropathy. That breadth is part of the appeal for Lilly, since a single validated approach to eliminating disease-causing antibodies could theoretically be applied across a range of otherwise unrelated conditions, giving the acquisition multiple potential paths to commercial value rather than resting on one single drug candidate.

This acquisition continues a pattern that has defined Lilly’s strategy through much of 2026. Flush with cash from the success of its weight-loss and diabetes franchise, the company has been unusually active on the acquisition front this year, using that financial strength to diversify its pipeline well beyond obesity and metabolic disease and into other high-value therapeutic categories, immunology chief among them.

For investors tracking the small and microcap biotech space, this deal reinforces a theme that has run through nearly every major pharma acquisition this year. Large, well-capitalized companies continue to pay significant premiums for clinical-stage biotechs with a genuinely differentiated mechanism of action, even when that science is still in early-stage trials with no approved product or meaningful revenue yet. What matters most to these acquirers is a validated, novel approach to a disease category with real unmet need, precisely what Merida’s precision antibody-elimination platform represents here. That pattern is worth watching closely, since it continues to set the valuation benchmark for smaller, independent biotechs pursuing similarly differentiated science across immunology and beyond.

Release – Ocugen Announces First Patient Dosed in Phase 3 Registrational Trial of OCU410 Modifier Gene Therapy for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

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Research News and Market Data on OCGN

September 1, 2026

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  • The single global Phase 3 trial, ArMaDa3 (NCT07770828), is the first pivotal gene therapy trial in geographic atrophy (GA)
  • U.S. Food and Drug Administration (FDA) granted OCU410 Regenerative Medicine Advanced Therapy (RMAT) designation, providing enhanced agency engagement throughout development and eligibility for accelerated approval and priority review
  • Phase 3 design fully aligned with FDA; Biologics License Application (BLA) filing anticipated in 2028
  • OCU410 is designed as a one-time subretinal gene therapy that addresses multiple disease pathways, offering a differentiated approach from approved complement inhibitors in the U.S. which address individual disease pathways and require ongoing intravitreal injections

MALVERN, Pa., Sept. 01, 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 first patient was dosed in the global Phase 3 registrational trial of OCU410 (AAV5-hRORA), its first-in-class modifier gene therapy candidate for GA secondary to dry age-related macular degeneration (dAMD). The Company also highlighted the recent FDA RMAT designation for OCU410, which supports a potential accelerated development and review pathway for the program.

“Dosing the first patient in our global Phase 3 trial, just weeks after receiving RMAT designation, marks a defining moment for the OCU410 program – and for the millions of people living with geographic atrophy. Outside the U.S., there are currently no approved treatments for GA, while in the U.S., available treatment options address only one of the four disease pathways and require ongoing, repeated eye injections,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “This is our third modifier gene therapy program to advance into late-stage development, demonstrating the strength of our platform and our vision for potentially delivering a one-time treatment for life.”

The initiation of dosing follows the successful completion of a Type B End-of-Phase 2 (EOP2) meeting with FDA’s Center for Biologics Evaluation and Research (CBER) in July 2026, resulting in alignment on all critical Phase 3 design elements, including primary and secondary endpoints, dose, adaptive design, and a single pivotal trial pathway to support a BLA.

“We are entering a global single Phase 3 with a well-defined program: a dose validated in a randomized, controlled Phase 2 study; an FDA-endorsed primary endpoint measuring the rate of lesion growth; and a secondary endpoint assessing functional vision,” said Mohamed Genead, MD, Chief Medical Officer of Ocugen. “The Phase 3 program builds on compelling 12-month Phase 2 data, which demonstrated a statistically significant 31% reduction in lesion growth with the optimal dose compared with control following a single subretinal injection, along with concordant preservation of the ellipsoid zone and no drug-related serious adverse events (SAEs) or adverse events of special interest (AESIs).”

OCU410 delivers the human retinoid-related orphan receptor alpha (RORA) modifier gene via a single subretinal injection of an AAV5 vector. Unlike therapies targeting a single pathway, OCU410 is designed to simultaneously address multiple pathophysiological drivers of GA-complement overactivation, chronic inflammation, oxidative stress, and lipid dysregulation. GA affects approximately 2–3 million people in the U.S. and Europe and is a leading cause of irreversible central vision loss in older adults, with prevalence expected to rise as the population ages.

According to study investigator Victor Gonzalez, MD, “Patients with geographic atrophy continue to face irreversible structural and functional loss of the retina, along with limited treatment options. The OCU410 Phase 3 study provides an important opportunity to evaluate a novel, potential one-time gene therapy approach that could lessen the burden of current treatments in the U.S., which require patients to undergo multiple injections every year.”

Global Phase 3 Registrational Trial Design
The Phase 3 trial is a global, multicenter, randomized, controlled study enrolling 237 subjects with GA secondary to dAMD, randomized 2:1 to a single 200 µL subretinal injection of OCU410 (5×1010 vg/mL) or an untreated control arm, with sites in the United States, Canada, Europe, and Latin America.

  • Primary endpoint: Rate of change of square root-transformed GA lesion area (√mm²/year) by fundus autofluorescence (FAF) at baseline, Month 4, Month 8, and Month 12, analyzed by MMRM.
  • Secondary endpoints: Proportion of subjects with Low-Luminance Visual Acuity (LLVA) loss ≥15 ETDRS letters at two consecutive visits through Month 12, providing a functional vision anchor to the primary anatomic endpoint; and rate of change of ellipsoid zone (EZ) area loss by SD-OCT.
  • Regulatory path: A single, adequate and well-controlled Phase 3 trial, aligned with FDA feedback, is intended to support a BLA filing anticipated in 2028. Discussions are ongoing with the European Medicines Agency (EMA) regarding alignment to potentially support a marketing authorization application (MAA) in Europe with this single Phase 3 trial.

RMAT Designation: Regulatory and Strategic Significance
On July 29, 2026, FDA granted RMAT designation to OCU410 based on Phase 2 clinical data demonstrating clinically meaningful efficacy and a favorable safety profile, with no serious adverse events related to OCU410 reported. RMAT designation is granted to regenerative medicine therapies intended to treat serious or life-threatening conditions where preliminary clinical evidence indicates the potential to address an unmet medical need.

For the OCU410 program, RMAT designation provides:

  • Eligibility for accelerated approval and priority review, which may compress the time from BLA submission to potential market entry.
  • All benefits of Breakthrough Therapy designation, including intensive FDA guidance on efficient development and organizational commitment involving senior FDA leadership.
  • Early and frequent FDA interactions on the use of surrogate and intermediate clinical endpoints reasonably likely to predict long-term clinical benefit-directly relevant to OCU410’s FAF-based anatomic primary endpoint.
  • Potential flexibility in satisfying post-approval requirements, including through expanded patient registries or real-world evidence.

Taken together with FDA alignment on the Phase 3 design and the initiation of dosing, RMAT designation further de-risks the regulatory pathway for OCU410 and reinforces the differentiation of a one-time, multi-pathway gene therapy in a GA market currently served only by chronically administered intravitreal complement inhibitors.

Supporting Phase 2 ArMaDa Data
The Phase 3 trial and the RMAT designation are supported by 12-month data from the Phase 2 ArMaDa trial (NCT06018558), a multicenter, randomized, controlled study of 51 subjects with GA secondary to dAMD.

  • Lesion growth (FAF): 31% reduction in GA lesion area growth rate in the medium dose group versus control at 12 months (p < 0.05) in the pivotal phase 3 population (lesion size of ≥2.5 mm2 and ≤17.5 mm2), a potential 2× treatment benefit relative to the 15% and 22% reductions reported for currently approved therapies in the U.S. at 12 and 24 months, respectively.
  • EZ preservation (SD-OCT): 27% reduction in ellipsoid zone area loss in the medium dose group versus control, a structural correlate of visual function.
  • Responder analysis: In the medium dose group, approximately 20% of treated subjects showed no disease progression; 75% demonstrated >30% reduction in lesion growth at 12 months.
  • Safety: No OCU410-related serious adverse events (SAEs) or adverse events of special interest (AESIs) reported to date.

About OCU410
OCU410 (AAV5-hRORA) is Ocugen’s investigational first-in-class modifier gene therapy, delivering the RORA gene via a single unilateral subretinal injection to regulate complement activation, neuroinflammation, oxidative stress, and lipid metabolism – multiple pathways implicated in the pathogenesis of GA. OCU410 has received RMAT designation from the FDA and Advanced Therapy Medicinal Product classification from the European Medicines Agency’s Committee for Advanced Therapies.

About Ocugen, Inc.
Ocugen, Inc. is a pioneering biotechnology company developing gene therapies for blindness diseases. 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 accelerated regulatory review or approval; 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]

Cadrenal Therapeutics (CVKD) – Alignment Reached With FDA On Phase 3 Design For CAD-1005 in HIT

Posted on by [email protected]


Tuesday, September 01, 2026

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

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

Phase 3 Design Can Move Forward With Expected Endpoints. Cadrenal announced that it held a Type D meeting with the FDA and has reached agreement on the design of the Phase 3 trial to test CAD-1005 in HIT (heparin-induced thrombocytopenia). This includes the primary endpoint, the protocol, and the statistical analysis plan (SAP). We see this as a significant step for the product and for the company’s plan to pursue collaboration to develop CAD-1005.

Primary and Secondary Endpoints Have Been Defined. The primary endpoint will be worsening HIT, defined as progression of thrombotic events through treatment day 14 or hospital discharge. A composite score composed of several aspects of thrombotic events will be used to measure progression. These include extension of an existing thrombus and the proportion of Serotonin Release Assay-positive (SRA+) patients with worsening composite thromboembolic events (CTEs) through Day 14 or hospital discharge.


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Release – NeuroSense Unveils Accelerated, Capital-Efficient Strategy to Advance PrimeC Toward Potential Approval in ALS

Posted on by [email protected]

Research News and Market Data on NRSN

Three-part program – AI-enabled characterization of PrimeC’s formulation advantage, an active-comparator trial against edaravone, and a streamlined pivotal pathway – is designed to strengthen PrimeC’s differentiation, shorten the time to potential commercialization, and significantly reduce overall development costs, complemented by a parallel regulatory pathway in Canada.

CAMBRIDGE, Mass., Aug. 31, 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 a redesigned development plan for PrimeC in amyotrophic lateral sclerosis, structured to reach a potential path for regulatory submission and approval faster and at materially lower cost than the Company’s previously planned development path.

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ALS drug development has been shaped by a single model: large, long, expensive confirmatory trials that few companies can fund and that people with ALS wait years to read out. NeuroSense’s plan replaces that single large commitment with three shorter, focused studies, each designed to answer a specific question that regulators, physicians, partners or payers routinely ask.

The redesigned strategy builds on the totality of evidence generated in NeuroSense’s Phase 2b PARADIGM study, including clinically meaningful effects on functional decline, statistically significant modulation of extracellular vesicle-associated TDP-43, consistent findings across multiple disease-related biomarkers, and encouraging long-term survival results. NeuroSense has already received FDA clearance to initiate its pivotal Phase 3 PARAGON trial. Together, these clinical, biomarker and regulatory advances provide the foundation for a more focused and capital-efficient development pathway.

AI-enabled characterization of PrimeC’s formulation advantage. PrimeC is an extended-release fixed-dose combination engineered to synchronize the pharmacokinetic profiles of its two active components. In a completed clinical pharmacokinetic study, PrimeC produced a synchronized exposure profile that was not reproduced when the individual components were administered together. NeuroSense is now applying AI-enabled modeling to these clinical data to quantify the magnitude of that difference, assess its consistency across individual patients and further characterize the contribution of PrimeC’s proprietary formulation. This work builds upon PrimeC’s established intellectual property position and is intended to support potential additional patent protection while providing clinicians, payers and prospective partners with an objective basis for distinguishing PrimeC from any co-administration of its individual components.

A direct comparative study against edaravone. NeuroSense plans to conduct an active-comparator clinical study designed to evaluate PrimeC directly against edaravone, an established ALS therapy. Head-to-head trials are not common in ALS, and differentiated results could provide people with ALS, clinicians, payers and prospective partners with compelling evidence of PrimeC’s relative clinical value and commercial potential.

A streamlined pivotal pathway. NeuroSense is evaluating an optimized design for its planned Phase 3 study (PARAGON) that would be substantially smaller and shorter in duration than previously planned, enriched for participants earlier in their disease course and intended to support an earlier regulatory submission. Any such pivotal design remains subject to alignment with FDA. The Company plans to discuss with the FDA whether its existing data may support full approval or, alternatively, an Accelerated Approval pathway, with an additional study conducted post-approval as required.

A parallel path to earlier access in Canada. NeuroSense has completed the pre-New Drug Submission process with Health Canada and is preparing a New Drug Submission for PrimeC, which the Company continues to target for December 2026. If accepted and ultimately approved, this pathway has the potential to make PrimeC available to Canadian patients on the strength of data already generated.

“One of the hardest constraints in ALS is not scientific – it is that the standard development path takes longer than patients have,” said Alon Ben-Noon, Co-Founder and Chief Executive Officer of NeuroSense. “We have asked a straightforward question: what is the shortest reasonable route from the data we already hold to a therapy people can actually receive? This plan is our answer. It is faster, it costs less, and it produces a stronger package – pharmacology, comparative clinical context, and a pivotal dataset – than the single-trial approach would have.”

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, with results published in JAMA Neurology showing slowing of functional decline relative to placebo. The Company also reported changes across multiple biomarkers associated with ALS, including microRNAs, consistent with PrimeC’s multi-target mechanism of action.

NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate its pivotal Phase 3 clinical trial (PARAGON) in ALS, to be conducted primarily in the United States. As described above, the Company is working with FDA on an optimized design for the study.

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 target several key mechanisms that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation, with the potential to inhibit disease progression.

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 3 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the potential benefits of the Company’s redesigned development strategy for PrimeC. Further, certain forward-looking statements, including statements regarding the potential regulatory pathways for PrimeC, are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. These risks include the potential for delay in the timing of the Phase 3 clinical trial (PARAGON) in ALS; potential delay in the Canadian New Drug Submission; the risk that the Company will not be able to obtain financing on acceptable terms, or at all; the risk that the Company will not regain and maintain compliance with the Nasdaq listing requirements; the risk that the strategic opportunities described will not materialize or result in the anticipated benefits to the Company; 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; 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.

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

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

SOURCE NeuroSense

For further information: Investor Relations: Or Eisenberg, Email: [email protected], Tel: +1315517554134

Release – Cadrenal Therapeutics Announces Positive Outcome from FDA Type D Meeting for Phase 3 Registration Study of CAD-1005 in Heparin-Induced Thrombocytopenia

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Primary Logo

Research News and Market Data on CVKD

FDA Alignment on Primary Endpoint and Path Forward for Phase 3 Registration Study

CAD-1005 Targets a Significant Unmet Need, with Approximately 50,000 Confirmed Acute HIT Diagnoses Annually in the U.S. and an Estimated $2 Billion in Peak Annual Revenue Opportunity

PONTE VEDRA, Fla., Aug. 31, 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 positive feedback from a Type D Meeting with the U.S. Food and Drug Administration (FDA) held on July 28, 2026. During the meeting, Cadrenal and the FDA aligned on key aspects of the protocol and Statistical Analysis Plan (SAP) for the Phase 3 registrational study of CAD-1005, the Company’s first-in-class 12-lipoxygenase (12-LOX) inhibitor in development to treat heparin-induced thrombocytopenia (HIT). HIT is a potentially life-threatening immune reaction to heparin, a widely used blood thinner, and can lead to dangerous blood clots.

In the U.S., heparin-induced thrombocytopenia (HIT) is a high-stakes emergency that affects approximately 50,000 patients with acute HIT each year. Current therapeutic options rely on standard anticoagulants to reduce thrombotic risk; however, they do not target the underlying immune mechanisms that drive this destructive cardiovascular cascade. CAD-1005 is a novel 12-LOX inhibitor designed to halt the core immune signaling pathway that drives platelet activation and vascular thrombosis. Developed as an essential add-on to standard anticoagulation, CAD-1005 targets a critical population and is projected to generate $2 billion in peak annual revenue.

During the Type D meeting, the FDA agreed on an optimized definition of worsening HIT for the primary endpoint, based on progression of thrombotic events through Day 14 of treatment or hospital discharge. To ensure high-quality, reliable endpoint evaluation across clinical sites, the worsening component of the primary endpoint will also include extension of an existing thrombus into a new vascular segment or bed, avoiding potential site-to-site variability from manual size measurements. The updated composite primary endpoint will measure the proportion of Serotonin Release Assay-positive (SRA+) participants with adjudicated new or worsening composite thromboembolic events (CTEs) through Day 14 or hospital discharge. Additionally, the FDA agreed to use placebo control in the Phase 3 trial, with standard anticoagulation therapeutics for both the CAD-1005 and placebo control arms.

“We are very pleased with the collaborative, constructive feedback from the FDA during this Type D meeting,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “Securing agreement on the primary endpoint definition and the blinding protocols for our saline control provides greater clarity on the regulatory path forward for CAD-1005. We have incorporated the Agency’s recommendations into our Phase 3 protocol and Statistical Analysis Plan, strengthening the design of a registration study intended to evaluate whether CAD-1005 can reduce dangerous thrombotic events that persist in patients with HIT despite current anticoagulant therapies.”

The Phase 3 trial design will also assess bleeding as a major safety endpoint using standard International Society on Thrombosis and Haemostasis (ISTH) criteria. All safety analyses will be conducted in the safety population of patients who receive at least one dose of the study drug.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions. The Company’s pipeline includes CAD-1005, tecarfarin, and frunexian. CAD-1005 is a novel investigational therapeutic in development for the treatment of heparin-induced thrombocytopenia (HIT) and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). 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 an Orphan Drug Designation (“ODD”) from the U.S. Food and Drug Administration (“FDA”) for prophylaxis of thrombosis in patients with HIT, FDA Fast Track designation for the treatment and prevention of HIT, and an orphan designation from the European Medicines Agency for the treatment of platelet-activating factor 4 disorders. Second-generation 12-LOX oral therapeutics (CAD-2000) are also in development for chronic indications.

The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and atrial fibrillation, 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. The Company recently submitted a request to the FDA for Rare Pediatric Disease Designation (RPDD) for tecarfarin for “Prevention of the Formation of Life-Threatening Blood Clots Inside Coronary Artery Aneurysms in Children with Kawasaki Disease”. Tecarfarin has also received Orphan Drug and Fast Track designations from the FDA.

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

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include, without limitation, statements regarding the planned Phase 3 registration study of CAD-1005, the development of CAD-1005 to treat HIT; CAD-1005 potentially halting the core immune signaling pathway that drives platelet activation and vascular thrombosis; CAD-1005 being an essential add-on to standard anticoagulation; CAD-1005 unlocking a projected $2 billion in peak annual revenue; the worsening component of the primary endpoint of optimized definition of worsening HIT assessing extension of an existing thrombus into a new vascular segment or bed, avoiding potential site-to-site variability from manual size measurements; the updated composite primary endpoint measuring the proportion of Serotonin Release Assay-positive (SRA+) participants with adjudicated new or worsening composite thromboembolic events (CTEs) through Day 14 or hospital discharge; the regulatory path forward for CAD-1005; the registration study evaluating whether CAD-1005 can reduce dangerous thrombotic events that continue to occur in patients with HIT despite current anticoagulant therapies; the Phase 3 trial design evaluating bleeding as a major safety endpoint using standard International Society on Thrombosis and Haemostasis (ISTH) criteria; all safety analyses in the Phase 3 trial being conducted in the true safety population of patients who receive at least one dose of the study drug; the Company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions; CAD-1005 being successfully developed to treat HIT and CSA-AKI; CAD-1005 selectively inhibiting 12-LOX, an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT; CAD-1005 being intended to be used alongside existing standards of care and being developed to address the underlying biological mechanisms that drive disease progression; second-generation 12-LOX oral therapeutics (CAD-2000) being developed for chronic indications; tecarfarin, a late-stage oral vitamin K antagonist, potentially preventing heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and atrial fibrillation, those with left ventricular assist devices, and potentially those with Kawasaki disease; and the FDA’s ultimate decision regarding the Company’s request for RPDD for tecarfarin for the prevention of life-threatening blood clots inside coronary artery aneurysms in children with Kawasaki Disease; Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to advance its programs to clinical trial readiness; the Company’s ability to enter into development, licensing, and commercialization transactions for CAD-1005, frunexian, and tecarfarin; the Company’s ability to secure nondilutive grants to advance its programs; 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, please contact:

Lytham Partners, LLC

Robert Blum, Managing Partner

602-889-9700

[email protected]

Release – While Measles Cases Continue to Increase in The USA and Globally, NanoViricides is Getting Ready for Clinical Trials of Its Revolutionary Broad-spectrum Drug Candidate NV-387 as A Treatment for Measles

Posted on by [email protected]

Research News and Market Data on NNVC

Monday, 31 August 2026 08:30 AM

SHELTON, CT / ACCESS Newswire / August 31, 2026 / NanoViricides, Inc., 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 cannot escape, provides an update on its Measles Drug Treatment Program.

While CDC is reviewing the two recent measles-related fatalities in Pennsylvania, the total number of confirmed measles cases in the USA has reached 2,903 as of August 27, 2026, in comparison to 2,289 confirmed cases in the whole year of 2025, indicating continuing expansion of measles1. Cases of Measles have been rising globally for different reasons. The measles outbreak in Bangladesh has continued to proliferate, claiming 19,218 confirmed cases with 99 fatalities in confirmed cases from 15 March to 30 August, 2026. During this period, a total of 1,37,347 patients with suspected measles were admitted to hospitals and 868 children have died of suspected measles, whereas 1,151 suspected measles cases with 4 deaths were reported in just the last 24 hours in Bangladesh2. The measles outbreak in Bangladesh has continued despite aggressive vaccination campaign that was undertaken since April-May 2026.

In the USA, since COVID-19 days, the MMR vaccination rate has fallen from 95.2% in 2019-2020 to an average of 92.4% in 2025-26, which can be clearly ascribed to the general public vaccine hesitancy that has resulted from the aggressive COVID vaccination policies. The current MMR vaccination rate is well below the 95% putative threshold that is generally agreed as necessary to block spread of measles, with approximately 280,000 unvaccinated kindergartners at risk of measles, according to CDC (ibid #1). The rate of “breakthrough” measles cases in the USA has remained steady at about 6% (~3% in single dose and ~3% in full 2-dose vaccinated individuals) (CDC data).

There is currently no approved drug for measles. Vaccine does not help a patient already infected with the measles virus. Vaccinating already measles-exposed persons to avoid disease spread is attempted yet measles has continued to spread in the USA.

Thus an effective treatment for Measles is an unmet medical need. NV-387 is the only drug candidate to our knowledge that has demonstrated strong in vivo activity against lethal infection with the Measles virus in a humanized animal model study.

NanoViricides is currently developing a Phase II clinical trial protocol for evaluating NV-387 as a treatment for measles. A draft is being circulated. The Company intends to bring this protocol under the purview of the US FDA in an IND process. Therefore, this work is expected to take some time.

NV-387 has been granted a “Rare Pediatric Disease Drug” (RPDD) Designation by the US FDA Office of Orphan Products Development (OOPD).

This RPDD designation enables that a Priority Review Voucher (PRV) can be issued to the Company upon a successful Marketing Application (i.e. New Drug Application) for the use of NV-387 as a treatment for Measles, provided all of the required conditions are met.

The Company can use the PRV, if granted, to reduce review times on another of its drug applications. Importantly, a PRV can be sold to another Pharma Company for accelerating their drug program as well, which provides a high value to the purchaser. Recently, a PRV has been sold for $195 Million3.

Sale of a PRV can bring cash to the Company even prior to revenues from commercialization of a drug product.

“The Rare Pediatric Disease Drug Designation and associated Priority Review Voucher that can be issued make a strong business case for development of NV-387 as a drug for the treatment of Measles,” said Anil R. Diwan, PhD., adding, “NV-387, as an effective drug would be an important tool to fight Measles resurgence in the USA and worldwide, when approved.”

FDA has granted both ODD and RPDD for NV-387 as a Treatment of Measles.

In addition to the PRV eligibility provided by the RPDD for NV-387 as a treatment of Measles, the Orphan Drug Designation qualifies NanoViricides for incentives including:

  • Tax credits for qualified clinical trials;
  • Exemption from certain user fees;
  • Potential seven years of market exclusivity after approval;

according to the US FDA4.

Measles continues to be a rare disease in the USA, with annual incidence rates well below 200,000 cases. Measles primarily affects children. These facts have qualified NV-387 for Measles Treatment for an Orphan Drug Designation, and also for a Rare Pediatric Disease Drug Designation. In a rare disease scenario, commercial revenue from the drug may be slow and small. The PRV is designed to incentivize drug development for rare pediatric diseases by providing additional business value.

Measles cases are rising across the Western world including several European countries and the UK, as well as the USA and Canada. Additionally Mexico and several other Central and South American countries have also been suffering from rising Measles outbreaks.

Measles is endemic globally; many countries that had achieved an elimination status for Measles have by now lost this status, due to severe outbreaks over the last three years5.

Measles is a highly contagious disease, and spreads via virus particles in bodily fluids upon close contact. A population vaccination rate of at least 95% is required to provide “herd immunity” and block community spread. Such a high rate is difficult to maintain for several reasons. Firstly, vaccine hesitancy is rising globally. Secondly, persons with co-morbidities such as immune-compromise status, diabetes, obesity, etc. do not respond fully to any vaccination. Even if vaccinated, such a person can still get Measles, suffering from possibly a mild disease, but will still be contagious and spread Measles. Additionally, the Measles virus continues to change, with the B and D genotypes in circulation currently, while the vaccines in use are still the ones developed for the A genotype in the 1960’s.

Further, very high rates of infections in vaccinated subjects (called “breakthrough cases”), from 14% to 57%, have occurred in some outbreaks6 suggesting that resistant virus strains may have been involved.

Therefore, an effective treatment for Measles is an unmet medical need, that is expected to become even more important in the near future than it is today. Only an effective treatment can help the patient and can avoid the potential severe disease scenarios such as encephalitis, neurological disabilities, and potential fatalities as well as immune amnesia that can result from severe disease.

Quicker recovery of a patient means less chances for spread and thus better ability to control an outbreak. This would require an effective treatment.

NV-387 is an extremely broad-spectrum antiviral drug that has demonstrated strong effectiveness in relevant animal models of multiple human viral infections. These include RSV, COVID, Influenza, Mpox, Smallpox, and Measles.

ABOUT NANOVIRICIDES

NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) 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.

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

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

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

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

Contact:
NanoViricides, Inc.
[email protected]

Public Relations Contact:
[email protected]

1 https://www.cdc.gov/measles/data-research/index.html

2 https://www.tbsnews.net/bangladesh/health/measles-death-toll-rises-967-4-more-die-24hrs-1528786

3 https://prvwatch.com/

4 https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products

5 https://www.cfr.org/articles/many-countries-eliminated-measles-why-is-it-coming-back-in-the-u-s-and-globally

6 Fappani,et al. Breakthrough Infections: A Challenge towards Measles Elimination?. Microorganisms 2022, 10, 1567. https://doi.org/10.3390/microorganisms10081567

SOURCE: NanoViricides

Release – GeoVax Advances GEO-MVA Toward Pivotal Phase 3 Study Implementation

Posted on by [email protected]
GeoVax, Inc.

Research News and Market Data on GOVX

Selections of CRO and European Clinical Sites Represent Significant Milestones Toward Initiation of the GEO-MVA Immunobridging Study

ATLANTA, GA – August 25, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and solid tumor cancers, today announced that it has selected the contract research organization (CRO) and European clinical trial sites planned to support the critical immunobridging portion of GEO-MVA-301, the Company’s pivotal Phase 3 clinical program evaluating GEO-MVA as a vaccine against mpox and smallpox.

The selections represent another important operational readiness milestone as GeoVax advances preparations for the European immunobridging study. The randomized, double-blind study is designed to compare the immunogenicity and safety of GEO-MVA with the licensed MVA vaccine in healthy adults.

The selected European clinical sites have extensive experience conducting late-stage vaccine studies and were evaluated for their ability to support timely recruitment across the study’s required adult age groups, intensive immunogenicity sampling, participant retention and high-quality clinical execution. GeoVax has also established contingency site capacity intended to provide additional recruitment flexibility if required.  The immunobridging study is designed to be completed within 8-12 weeks, initiated in Q4 2026, with results announced by mid-2027.

“Selection of our CRO and European clinical sites moves GEO-MVA another important step from development planning toward clinical execution,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “We now have critical components of the pivotal study infrastructure identified and aligned, and the program is increasingly taking shape as an execution-ready clinical program.”

Dodd continued, “These milestones are particularly important because they reflect progress across multiple workstreams – not simply clinical-site selection. Manufacturing readiness, regulatory planning, clinical operations, comparator strategy and site preparation are being brought together around a defined pivotal development pathway. We believe these activities position us to move efficiently toward study initiation as the remaining requirements are completed.”

A Focused Pivotal Development Strategy

The immunobridging study is planned to enroll 500 healthy adult participants at European clinical sites and evaluate whether immune responses generated by GEO-MVA are non-inferior to those generated by the licensed MVA comparator vaccine.  GeoVax expects meeting the non-inferiority criteria will form the basis for approval by the European Medicines Agency (EMA), providing eligibility for GEO-MVA procurement.

The study will evaluate neutralizing antibody responses and seroconversion against vaccinia and mpox viruses, together with additional immunogenicity and safety measures. Enrollment is planned across multiple adult age groups to support a representative clinical dataset.

The study design incorporates an initial safety lead-in cohort, followed by enrollment of the remaining immunobridging study participants. The CRO and site-selection process emphasized capabilities considered important for efficient execution of the pivotal program, including:

  • Experience conducting Phase 2 and Phase 3 vaccine trials;
  • Demonstrated ability to timely recruit healthy adult volunteers; Experience managing registration-enabling clinical programs;
  • Established clinical and regulatory infrastructure in Europe;
  • Ability to support intensive immunogenicity sampling and rigorous safety oversight; and
  • Recruitment capacity and contingency planning designed to protect program timelines.

“Our objective has been to systematically remove the operational dependencies between GEO-MVA and initiation of the pivotal study,” Dodd said. “With each readiness milestone, the program becomes more tangible: the clinical pathway is defined, the vaccine has been manufactured, and we are now putting the clinical execution infrastructure in place. There is still work ahead, including regulatory and financing requirements, but the pieces necessary to execute the program are increasingly coming together.”

About GEO-MVA

GEO-MVA is GeoVax’s MVA-based vaccine candidate being developed for prevention of mpox and smallpox. GEO-MVA is a highly attenuated, replication-deficient poxvirus vaccine derived from the same original MVA lineage as currently licensed MVA vaccines. The planned GEO-MVA-301 pivotal program is designed to evaluate the immunogenicity and safety of GEO-MVA relative to an approved MVA comparator vaccine and, if successful, support regulatory submissions seeking marketing authorization.

About GeoVax

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

Forward-Looking Statements

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

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

Company Contact:
[email protected]
678-384-7220

Media Contact:
Jessica Starman
[email protected]

Release – GeoVax Initiates Global Health Outreach to WHO, Africa CDC and Other Agencies Regarding Ebola Vaccine Portfolio Amid Expanding Outbreak

Posted on by [email protected]
GeoVax, Inc.

Research News and Market Data on GOVX

Emerging Evidence of Potential Protection From Authorized Ebola Zaire Vaccine Against Bundibugyo Virus Provides Rationale for Evaluating GeoVax’s MVA-Based Ebola Vaccine Candidates

ATLANTA, GA – August 24, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancers, today announced that it has expanded outreach to global and regional public health organizations regarding the potential relevance of its Modified Vaccinia Ankara (MVA)-based hemorrhagic fever vaccine portfolio amid the expanding Ebola disease outbreak caused by Bundibugyo virus (BDBV) in various regions of Africa.

The outreach follows GeoVax’s recent announcement highlighting its willingness to contribute vaccine candidates, materials and scientific expertise to the global response. GeoVax is seeking to determine whether its existing hemorrhagic fever vaccine candidates and MVA platform capabilities may warrant evaluation or could support broader Ebola preparedness and response efforts.

Of particular interest is GeoVax’s Zaire Ebola vaccine candidate, GEO-EM01, which previously demonstrated 100% protection following a single intramuscular dose in a non-human primate lethal-challenge study. All vaccinated rhesus macaques survived lethal Zaire Ebola virus challenge, with no live virus detected in tissues from vaccinated animals. The research, conducted in collaboration with scientists at the National Institute of Allergy and Infectious Diseases’ Rocky Mountain Laboratories, was originally published in Scientific Reports.

Recent scientific evidence has increased interest in whether vaccines developed against Zaire ebolavirus may also provide some degree of cross-protection against Bundibugyo virus. WHO’s Technical Advisory Group on Candidate Vaccine Prioritization recently recommended that the licensed Ebola Zaire vaccine Ervebo® be prioritized for inclusion in a Phase 3 study during the current Bundibugyo outbreak, based on an evolving body of animal, laboratory and human immune-response data suggesting potential cross-protection. Importantly, the extent of such protection remains uncertain and must be established through controlled clinical evaluation.

“The evolving science raises an important question that we believe warrants evaluation,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “Our Ebola Zaire vaccine demonstrated compelling protection in a stringent non-human primate challenge model, including 100% survival following a single dose. We do not know whether that protection extends to Bundibugyo virus. However, emerging evidence that a Zaire-directed Ebola vaccine may provide some degree of protection against BDBV provides a scientific rationale for asking that question. We are reaching out to the appropriate global health organizations to determine whether our vaccine candidate, materials and MVA platform expertise warrant further evaluation.”

Seeking Various Paths for Evaluation and Development

GeoVax’s outreach is focused on organizations involved in global health security, epidemic preparedness, vaccine evaluation and outbreak response. The Company is exploring potential opportunities that could include independent evaluation of existing vaccine materials, scientific collaboration, public-private partnerships, licensing arrangements or other externally supported development pathways.

GeoVax believes this approach could provide a mechanism for assessing and potentially advancing its hemorrhagic fever vaccine portfolio while preserving the Company’s operational and capital focus on GEO-MVA, its lead infectious disease program targeting mpox and smallpox.

“We believe these assets represent strategic optionality for GeoVax, but our intention is not to divert resources from GEO-MVA,” Dodd continued. “The appropriate path is to determine whether public health organizations, development partners or other third parties see sufficient scientific and strategic value to support further evaluation. If so, we are prepared to explore collaborative structures capable of advancing these assets responsibly.”

GEO-MVA on Schedule for Pivotal Phase 3 Immunobridging Study Initiation in Q4 2026

GeoVax’s primary infectious disease development priority remains GEO-MVA, its MVA-based vaccine candidate for the prevention of mpox and smallpox. The Company is advancing toward a pivotal Phase 3 immunobridging clinical program designed to compare immune responses generated by GEO-MVA with those generated by an established MVA vaccine.

As part of its GEO-MVA activities, GeoVax is developing relationships with healthcare, research and public health organizations in regions confronting significant infectious disease challenges. The Company believes these relationships, together with its broader MVA expertise, provide a foundation for exploring collaborative opportunities involving other high-consequence infectious diseases.

“Our priority remains execution of the GEO-MVA program,” Dodd concluded. “At the same time, the current Ebola outbreak demonstrates why maintaining a portfolio of technologies addressing high-consequence pathogens can have strategic value. Where an opportunity exists to leverage external expertise and resources to evaluate those assets without distracting from our lead program, we believe it is appropriate – and potentially important – to pursue it.”

About GeoVax’s Hemorrhagic Fever Vaccine Portfolio

GeoVax has developed MVA-based vaccine candidates targeting Zaire ebolavirus, Sudan ebolavirus and Marburg virus. The programs have undergone preclinical evaluation, including lethal-challenge studies in non-human primates, and have demonstrated encouraging protective efficacy.

GeoVax’s Zaire Ebola vaccine candidate, GEO-EM01, utilizes the Company’s MVA-VLP technology and previously demonstrated 100% survival in a small rhesus macaque lethal-challenge study following either a single-dose or two-dose vaccination regimen. The single-dose study represented the first reported demonstration that a replication-deficient MVA vector could provide complete protection against lethal Zaire Ebola virus challenge following a single vaccination in rhesus macaques.

GeoVax is evaluating opportunities for collaboration, licensing, public-private partnerships and other externally supported structures that could enable further evaluation and development of these assets while maintaining the Company’s primary operational and capital focus on GEO-MVA.

About GeoVax

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

Forward-Looking Statements

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

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

Company Contact:
[email protected]
678-384-7220

Media Contact:
Jessica Starman
[email protected]

Release – GeoVax Chairman and CEO David Dodd to Participate in 2026 Georgia Life Sciences Summit

Posted on by [email protected]
GeoVax

Research News and Market Data on GOVX

Former Georgia Life Sciences Chair Selected for CEO Spotlight and Private Global Health Policy Roundtable With U.S. Rep. Rich McCormick

ATLANTA, Ga., August 20, 2026 — GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today announced that Chairman, President and Chief Executive Officer David Dodd will participate in two leadership and policy events associated with the 2026 Georgia Life Sciences Summit, August 25–26, at the Performing Arts Center in Sandy Springs, Georgia.

Dodd, a former Chair of Georgia Life Sciences, has been selected as one of four biotechnology CEOs participating in “CEO Spotlights: Decisions That Define a Company,” presented by BioSpark Labs, on August 26. The CEO Spotlights feature 10-minute, TED-style presentations focused on pivotal decisions, challenges and inflection points that have shaped the trajectory of each participating company.

Dodd will draw upon GeoVax’s evolution to discuss the leadership and strategic decisions involved in building and advancing a biotechnology company through changing scientific, financial, regulatory and public-health environments. The presentation will offer a candid perspective on navigating uncertainty, allocating resources, advancing innovative technologies and maintaining a long-term strategic vision while confronting the realities inherent in building a clinical-stage biotechnology company.

GeoVax today is advancing a diversified portfolio built around its Modified Vaccinia Ankara (MVA) vaccine platform and novel oncology technologies. Its programs include GEO-MVA, the Company’s vaccine candidate for mpox and smallpox; MVA-based vaccine candidates targeting Ebola, Sudan Ebola and Marburg viruses; and Gedeptin®, a novel gene-directed therapy for solid tumors.

“Building a biotechnology company is rarely a straight line,” said Dodd. “It requires making consequential decisions with incomplete information, adapting to changing circumstances and remaining focused on the scientific and strategic opportunities that can ultimately create meaningful value. I look forward to sharing some of the decisions and lessons that have shaped GeoVax’s journey with Georgia’s life sciences community.”

Dodd will be joined in the CEO Spotlight program by Samir Patel, President and CEO of Moonlight Therapeutics; Dr. Nikhil L. Shah, CEO and Co-Founder of Nephrodite; and Gareth Sheridan, Founder and CEO of Nutriband.

Private Roundtable with Congressman Rich McCormick

On August 25, Dodd will also participate in a private roundtable discussion with U.S. Representative Rich McCormick (GA-07), convened by Georgia Life Sciences, the Global Health Technologies Coalition and The Kyle House Group.

The roundtable will bring together leaders from Georgia’s global health, biotechnology, nonprofit and private sectors to discuss the state’s leadership in advancing global health and development through innovation, research and public-private partnerships. Participants will also have the opportunity to discuss key policy priorities and issues before Congress directly with Congressman McCormick.

For GeoVax, the discussion provides an opportunity to contribute perspectives informed by the Company’s work in infectious disease vaccines, medical countermeasures and global health preparedness, as well as the challenges faced by emerging biotechnology companies working to translate scientific innovation into products addressing significant public-health needs.

“Georgia has developed an increasingly important life sciences and global health ecosystem that brings together scientific innovation, entrepreneurship, academic expertise, public policy and investment,” Dodd said. “Having previously served as Chair of Georgia Life Sciences, I am especially pleased to participate in this year’s Summit and to engage with Congressman McCormick and other leaders on how we can further strengthen Georgia’s – and America’s – capacity for biotechnology innovation, health security and global health leadership.”

The Georgia Life Sciences Summit is the organization’s flagship annual gathering, bringing together leaders from industry, academia, government and the investment community to address major issues affecting scientific research, product development, financing, business development and public policy while showcasing innovation across Georgia’s life sciences sector.

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] 

Moderna Doubled Today on a Cancer Vaccine Breakthrough

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Moderna (Nasdaq: MRNA) shares more than doubled Wednesday after the company and Merck (NYSE: MRK) announced their personalized mRNA cancer vaccine met its primary and key secondary endpoints in a pivotal Phase 3 trial, the first positive late-stage result ever recorded for an individualized neoantigen cancer therapy and for any mRNA-based cancer treatment. The rally lifted biotech stocks broadly, with investors treating the result as validation for an entirely new category of oncology treatment that has been in development for more than a decade.

The trial, called INTerpath-001, enrolled 1,137 patients with completely resected stage IIB-IV melanoma, the deadliest form of skin cancer. Patients received either the vaccine, known as intismeran autogene, alongside Merck’s Keytruda, or Keytruda alone. The combination produced statistically significant and clinically meaningful improvements in recurrence-free survival, the trial’s primary endpoint, along with a secondary measure of how long patients went without their cancer spreading to distant parts of the body. No new safety signals emerged.

How the Vaccine Actually Works

What makes intismeran genuinely novel is that it is not a single, mass-produced product. Each dose is manufactured individually based on the specific mutational fingerprint of a patient’s own tumor, sequenced from surgically removed tissue, and designed to train the immune system to recognize as many as 34 distinct targets unique to that patient’s cancer. Neoantigen vaccines built on this personalized model have been discussed as a theoretical possibility in oncology for years. This is the first randomized Phase 3 trial to actually prove the concept works in a large patient population, which is precisely why the result is being described across the biotech industry as a landmark moment rather than an incremental clinical update. Notably, the trial was stopped at its first interim analysis, meaning the question of whether the vaccine ultimately extends overall survival, not just delays recurrence, remains open and could take years to fully answer. The companies have indicated they intend to pursue regulatory filings quickly, describing a timeline measured in months rather than years.

What It Means for Smaller Biotech Companies

For investors tracking small and microcap biotech, a validation event of this scale rarely stays contained to the two companies involved. Proof that personalized, sequencing-based cancer vaccines can succeed in a randomized Phase 3 trial provides real clinical and regulatory validation for an entire mechanism, and that validation tends to lift sentiment and capital allocation across every smaller company pursuing related or adjacent immuno-oncology approaches, not just the two large caps that generated today’s headline. Smaller oncology-focused biotechs, including companies like MAIA Biotechnology, both advancing their own differentiated approaches to hard-to-treat cancers, operate in exactly the kind of therapeutic environment where a breakthrough of this magnitude tends to draw renewed institutional attention to the broader category, even when their own mechanisms differ meaningfully from Moderna and Merck’s personalized vaccine platform.

This pattern is consistent with what we detailed in our recent look at the current biotech catalyst environment, where clinical breakthroughs at any point in the sector, whether at a large pharma partnership or a clinical-stage microcap, tend to reprice risk and opportunity across the entire space rather than staying isolated to a single company’s stock.

Release – The Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for Ebola in DR Congo to Fight the Current Largest Ever and Expanding Ebola Outbreak to Begin Soon

Posted on by [email protected]

Research News and Market Data on NNVC

Shelton, Connecticut – Tuesday, August 18, 2026.

NanoViricides, Inc. (NYSE American: NNVC) (the “Company”), a clinical stage leader developing antiviral drugs that viruses cannot escape, announces that the Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for the Current Bundibugyo Ebolavirus and other Ebola viruses is expected to begin soon in the Democratic Republic of Congo (“DRC”).

Professor Patrick Katoto has been appointed as the principal investigator to lead this clinical trial. Dr. Katoto 1 is Co-Director and Co-Founder of the Centre for Tropical Diseases and Global Health (“CTDGH”), and Associate Professor of Medicine, Epidemiology and Global Health at the Catholic University of Bukavu, Bukavu, DRC. He has more than ten years of working experience as a clinician, academic, and advisor for multiple public and private health agencies. He works on various projects of global health concern to produce evidence to inform decision-making to address Ebola, COVID-19, HIV, tuberculosis, vaccine-preventable diseases, non-communicable diseases, as well as air pollution in resource-limited settings. He has published over fifty papers in renowned journals such as Lancet and JACC. He has co-authored a paper entitled “How to prepare for the next inevitable Ebola outbreak: lessons from West Africa [2014-2016]” in 2024 in Nature Medicine 2.

Patrick is a Fogarty Fellow (HIV-comorbidity research training program in Low and Medium Income Countries (“LMIC”s), a Fellow of the Central & West Africa Implementation Science Alliance for the establishment of a network in implementation research (known as “CAWISA”, in collaboration with the University of Maryland Baltimore, Institute of Human Virology Nigeria, Yale University and other organizations) to accelerate the scaling up of novel diagnostic tools and clinical guidelines to improve children’s health, a fellow of the Pan-African Scientific Research Council and a member of the Institute for Health Metrics’ Global Burden of Diseases project (University of Washington).

Under the leadership of Professor Katoto, NanoViricides, as the drug sponsor of NV-387 Oral Gummies, has received regulatory approval to begin a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for the Current Bundibugyo Ebolavirus and other Ebola viruses, from the local regulatory agency ACOREP in the Democratic Republic of Congo (DRC).

Professor Katoto and his team have already actively started the preparatory work including staff training, to accelerate time to first patient dosing, even without waiting for the regulatory approval. This has a given a head start to our efforts.

Additionally, the drug product for the clinical trial is already available in DRC, because of the impending Phase II clinical trial of NV-387 Oral Gummies as a Treatment for Mpox.

Therefore, it is anticipated that the first Ebola patient dosing with NV-387 oral gummies under this clinical trial can be expected to occur within a few weeks, barring impediments caused by the very ebola disease outbreak that the trial is designed to respond to.

“We now eagerly await the first dosing of Ebola patients 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, “We, our colleagues, and our partners are hoping that this orally available, unique and revolutionary broad-spectrum antiviral drug succeeds in combatting the Bundibugyo virus for which there is no known treatment or vaccine.”

1 https://ctdgh.org/researchers/prof-dr-katoto-pdm , also see-https://cawisa-afr.org/team-member/patrick-dmc-katoto/

2 http://europepmc.org/abstract/med/39420216
As the Ebola outbreak continues to expand, several limitations on travel are being instated. There are also limitations on availability of resources such as PPE and diagnostic kits, which are compounded by the travel and other restrictions. These on-ground situations have caused delays in our efforts, and we anticipate such delays to continue due to the tenuous outbreak situation.

The current Ebola Virus Disease (EVD) caused by the Bundibogyo ebolavirus (BDBV) is now the largest ever ebola outbreak, as well as the fastest growing ebola outbreak in DRC. As of August 14, 2026, there have been 4945 confirmed cases, and 2325 deaths, with 101 new cases being confirmed in the previous 24 hrs 3. In comparison, as of August 6, 2026, there were reported 4,141 confirmed cases and 1,889 confirmed deaths due to this virus. Only 829 confirmed cases were then reported to have recovered from the disease. The crude fatality rate (crude CFR) is 46%, according to the WHO 4.

This is an increase of 20% in cases as well as deaths over the prior week. At this rate, the current deadly outbreak is on track to exceed the worst ever ebola zaire outbreak in West Africa in 2014-2016. In that outbreak, 28,616 cases and 11,310 deaths were recorded across Guinea, Liberia and Sierra Leone, according to the World Health Organization (ibid, #3).

An oral drug to treat patients, to prevent contacts from contracting the disease, and to keep healthcare workers safe, is sorely needed to combat this outbreak. There is 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. Om Sai 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 (see below) 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 2014-2016 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.

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.

An oral drug called obeldesivir, which is related to the known drug remdesivir that previously failed in clinical trials against Ebola Zaire, is being tried in a clinical trial, but only as a preventative measure, and not as a treatment of active infection.

NanoViricides has retained Om Sai Clinical Research Private Limited, India, (Om Sai CRO) as the CRO for this Phase II clinical trial for Ebola in DRC. Om Sai CRO has been instrumental in putting together the team with Prof. Katoto and other renowned experts and with support from the University ofukavu and in the Ebola-affected region to lead and execute the clinical trial of NV-387 Oral Gummies as a Treatment for Ebola viruses in DRC.

This Ebola outbreak continues to increase in spread and is now present in at least six provinces in

3  https://www.cbc.ca/news/world/drc-ebola-outbreak-deadliest-in-history-9.7309296

4 https://www.who.int/emergencies/alert-and-response . The crude CFR is estimated as number of

deaths (1,889) divided by number of reported confirmed cases (4,141) since May 16, the declaration of the epidemic. Most of the remaining 1,423 cases are likely to be continuing as disease-stricken. The crude CFR does not take into account the delay period between case confirmation to case fatality (i.e. the disease duration), and results in an underestimate of the case fatality rate while the epidemic is still increasing, as is the case at present in DRC.

The largest ever Ebola outbreak was the West Africa Ebolavirus (Zaire) outbreak, in 2013-2016, that 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.

DRC and threatening South Sudan 5. 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 6. Additionally, Ebola is now found to have spread into displacement camps that host over 4.4 million displaced persons due to internal warfare, adding another high risk population pool with poor drinking water, sanitation and medical resources to further fuel this outbreak, according to the UN New Service 7.

Treatments under consideration except for NV-387 which is orally available, 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, called the “PARTNERS” clinical trial, evaluating Remdesivir infusion, an antibody cocktail MBP134 infusion, and MBP134 infusion plus Remdesivir infusion, has started according to WHO with first patient having received infusion of the antibody cocktail on July 2, 2026 8.

“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 9. 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. Viruses also escape antibodies readily by mutations 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.

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 DRC. The rare Bundibugyo strain of Ebola virus causing the current outbreak appears to be its new variant, likely freshly introduced from some animal source 10, such as fruit bats.

A new clinical trial of an Oxford University designed Bundibugyo-specific vaccine has also started in DRC, in addition to the treatment trials of antibody and remdesivir infusions (ibid, #8). Further, Ervebo, a vaccine approved for Ebolavirus Zaire, may also enter clinical trials for the protection of uninfected persons from the distinctly different Bundibugyo ebolavirus due to the enormity of the

5 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

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

7 https://www.msn.com/en-xl/africa/top-stories/ebola-virus-reaches-displacement-camps-in-dr-congo/ar-AA29A5ts?ocid=BingNewsSerp

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

9 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/

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

emergency posed by the current outbreak despite reservations regarding a potentially imperfect vaccine 11. Om Sai is the CRO leading the Company’s Phase II clinical trial of NV-387 Oral Gummies as a

Treatment for Mpox in DRC, and the same CRO is also leading the newly approved Ebola clinical trial.

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 the Phase II clinical trial for the Treatment of Ebola only upon approval by the regulatory agency, which has now been approved.

“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 others 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.

“Only safe and effective broad-spectrum antiviral drugs like NV-387 that can effectively tackle 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, “Today, NV-387 is the only drug in clinical development with such broad-spectrum potential that promises to combat diverse epidemics like Mpox and Ebola, to the best of our knowledge.”

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 12. Unfortunately, the outbreak appears to be even more aggressive than the CDC model, with over 2,000 deaths in less than three months, over 4,000 confirmed cases, and over 10,000 estimated total cases 13.

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 14.

NV-387 is a broad-spectrum antiviral that mimics the host-side feature called heparan sulfate

11 https://www.msn.com/en-us/health/general/ebola-cases-top-4-000-in-drc-as-who-urges-ervebo-vaccine-trial/ar-AA29CX9f?ocid=BingNewsSerp .

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

13 The WHO and Africa CDC have estimated that the confirmed case number substantially under-represents actual case numbers which could be at least double or even more than confirmed cases. See #5.

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

proteoglycan (HSPG) 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 prior to gaining entry into the cell. Thereafter, followed by entry into the cell inside endosomes, the ebolavirus surface glycoprotein is substantially degraded, opening up its site for binding to its cognate receptor called NPC1, thereby entering into 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.

All previous anti-Ebola efforts have been focused on vaccines and antibodies 15. 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.

In contrast, 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.

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.

At present, BDBV has been consistently demonstrating crude CFR exceeding 46% in DRC. 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 rather 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.

An irony is that because of the high case fatality rate (CFR) approaching 50%, the spread of ebolaviruses 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.

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.

The US Government is active in ensuring that suspected or confirmed ebolavirus cases do not

15 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.

enter the general population in the USA. 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.

Travelers going to and from Central Africa need to constantly check travel restrictions as well as travel limitations in light of these changing outbreak conditions.

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.
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Source: NanoViricides, Inc.