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.
Mpox Vaccine Clinical Supplies Expected To Be Ready Soon. GeoVax announced the completion of clinical supply testing of GEO-MVA, its modified vaccinia ankara (MVA) vaccine for Mpox/smallpox. The release of vaccine that can be used in clinical trials is expected in early April. This is an important milestone in preparation for the Phase 3 trial planned for late FY2026.
Preparation for Phase 3 Bridging Study and Commercialization. GeoVax is preparing for an immune bridging study to show GEO-MVA stimulates an immune response that is non-inferior to a commercial Mpox vaccine. The study was designed to meet requirements for the European Medicines Agency’s expedited development pathway for Marketing Authorization.
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Clinical Product Release Testing Completed in Support of Pivotal Phase 3 Trial
Atlanta, GA – March 25, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, today provided a development update on its GEO-MVA vaccine program for protection against mpox and smallpox, highlighting continued progress toward initiation of its planned pivotal Phase 3 clinical study.
GeoVax announced that GEO-MVA clinical supplies have completed the required release testing and final release of the product for clinical use is scheduled for early April. Upon final release, sufficient clinical material will be available to fully support the planned immune bridging study designed in accordance with guidance from the European Medicines Agency (EMA).
This impending availability of GEO-MVA vaccine clinical material further advances the program towards initiation of the immune bridging study, a critical step toward regulatory Marketing Authorization under the EMA’s expedited development pathway, scheduled to initiate in the second-half of this year.
Advancing Toward a Pivotal Inflection Point
“The availability of GEO-MVA cGMP clinical material marks a significant advancement for the GEO-MVA program,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “With final product release expected shortly, we are entering the final preparatory phase ahead of initiating our immune bridging study positioning GeoVax at a pivotal inflection point, moving toward potential regulatory approval and subsequent commercialization.”
The planned immune bridging study is designed to demonstrate comparability to an approved MVA vaccine using immunological endpoints, consistent with EMA guidance supporting a streamlined development pathway.
Parallel Progress Toward Commercial Readiness
As recently announced, we have initiated outreach discussions in support of potential procurement and preparedness contracting, positioning the Company for rapid GEO-MVA vaccine distribution upon regulatory and/or Emergency Use Licensing issuance. These discussions include organizations that influence or directly procure vaccines for national stockpiles, military preparedness programs, and international outbreak response initiatives.
“We are encouraged by the early engagement with global health and preparedness stakeholders,” Dodd added. “These discussions, alongside our clinical progress, underscore the increasing recognition of the critical need to expand global supply of MVA-based vaccines.”
Addressing a Critical Global Supply Gap
GEO-MVA is being developed to address a significant and well-recognized gap in global vaccine preparedness. Recent mpox outbreaks and evolving epidemiological patterns have reinforced the need for sustained preparedness, including expanded manufacturing capacity and diversified supply source. The current supply of MVA vaccine is concentrated in a single commercial manufacturer, limiting redundancy in a platform considered essential for protection against both mpox and smallpox. GeoVax believes GEO-MVA has the potential to serve as an important additional source of MVA vaccine supply supporting:
National stockpile programs
Global outbreak response efforts
Military and biodefense preparedness initiatives
About GEO-MVA
GEO-MVA is GeoVax’s candidate vaccine for protection against mpox and smallpox based on the Modified Vaccinia Ankara (MVA). The program is advancing under an expedited regulatory pathway supported by EMA scientific advice, which enables potential regulatory approval based on a single immune bridging study demonstrating non-inferiority to an approved MVA vaccine.
Following successful completion of the planned study, GEO-MVA is expected to advance toward regulatory submission and potential commercialization as an additional source of MVA vaccine supply for global preparedness and biodefense programs.
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’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. 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.
Merck (NYSE: MRK) announced Tuesday it has entered into a definitive agreement to acquire Terns Pharmaceuticals (Nasdaq: TERN), a clinical-stage oncology company, for $53.00 per share in cash — representing an approximate equity value of $6.7 billion, or roughly $5.7 billion net of acquired cash. The deal carries a 31% premium to Terns’ 60-day volume-weighted average price and a 42% premium to its 90-day VWAP as of March 24, 2026.
The acquisition is a textbook small-cap-to-acquisition story. Less than 18 months ago, Terns was trading below $2 per share with a market cap well under $200 million. By the end of 2025, the stock had surged more than 770% year-to-date on the back of compelling Phase 1 clinical data. As of Tuesday’s announcement, shareholders who held through the volatility are looking at a $53 payday — a return that underscores exactly why early-stage biotech remains one of the most asymmetric bets in the small and microcap universe.
At the center of this deal is TERN-701, an investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor (TKI) currently being evaluated in the Phase 1/2 CARDINAL trial for patients with Philadelphia chromosome-positive (Ph+) chronic phase chronic myeloid leukemia (CML). Specifically, the drug targets patients who have already received at least one prior TKI and experienced treatment failure, suboptimal response, or intolerance.
What separates TERN-701 from existing CML therapies is its mechanism and early efficacy signal. The drug is designed to bind to the ABL myristoyl pocket — a distinct binding site from most approved TKIs — giving it the potential to work in patients who have already failed other therapies, including those with difficult resistance mutations like T315I. In clinical data presented through the CARDINAL trial, 64% of efficacy-evaluable patients achieved major molecular response by 24 weeks, with 75% achieving MMR among those treated at doses above 320mg. The safety profile has also been notably clean, with low rates of severe adverse events, minimal blood pressure changes, and low lipase elevation — a meaningful differentiator given the side-effect profiles associated with several competing agents.
The FDA recognized the drug’s potential in March 2024, granting TERN-701 Orphan Drug Designation for the treatment of CML. Merck is now betting that designation translates into a commercially viable, potentially best-in-class therapy within its growing hematology portfolio — which already includes three Phase 3 candidates across leukemias, lymphomas, and myeloproliferative neoplasms.
Merck expects to account for the transaction as an asset acquisition, with the deal expected to close in the second quarter of 2026, pending a successful tender offer and Hart-Scott-Rodino antitrust clearance. The charge will be approximately $5.8 billion, or roughly $2.35 per share, reflected in both Q2 and full-year 2026 results.
For the small and microcap investor community, this deal is more than just a pharma headline. It’s a reminder that the path from sub-$2 clinical-stage company to a multi-billion-dollar buyout target is very much alive — and that the CARDINAL data milestones many overlooked in 2024 were the signals that mattered most.
CAMBRIDGE, Mass., March 24, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today provided an update on key regulatory and clinical milestones for its lead asset, PrimeC.
A pre-New Drug Submission (pre-NDS) meeting with Health Canada has been rescheduled to May 2026.
The decision was made to allow for the inclusion of additional emerging clinical, biomarker and survival data and analyses in the briefing package, which the Company believes will meaningfully strengthen the scientific and clinical foundation supporting PrimeC.
The Company remains focused on advancing PrimeC under the NOC/c pathway in Canada, which is designed to facilitate earlier access to promising therapies addressing serious unmet medical needs.
Alzheimer’s Disease Program Update
The Company expects to report clinical and biomarker results from its Alzheimer’s study in the coming weeks.
Continued Momentum Across Key Programs
NeuroSense continues to advance its clinical and regulatory strategy for PrimeC, supported by our previously disclosed:
Statistically significant survival benefit (65% reduction in risk of death)
FDA clearance to initiate the pivotal Phase 3 PARAGON trial in ALS
“As we generated additional valuable data, we believe it is strategic to incorporate these findings and analyses into our regulatory interactions,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “Our objective is to present the most comprehensive and robust dataset possible to Health Canada, thereby maximizing the likelihood of a constructive and efficient regulatory pathway. We believe this approach positions the Company ahead of several important value inflection points across its ALS and Alzheimer’s programs expected in 2026.”
About NeuroSense
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.
About PrimeC
PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.
About ALS
Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.
Forward-Looking Statements
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. 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 timing of regulatory filings, reporting of data, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding future development of 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 uncertainty regarding the timing of regulatory filings, meetings and regulatory decisions; outcomes and the timing of current and future clinical trials; the risk the PrimeC will not advance towards later-stage development, timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 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.
Optimal dose intended for Phase 3 demonstrates statistically significant reduction in lesion growth (31%) versus control at 12 months (p< 0.05)
Potential 2X treatment benefit compared to 15% and 22% reductions reported for currently approved therapies at 12 and 24 months, respectively
No serious adverse events and no adverse events of special interest related to OCU410 reported to date
MALVERN, Pa., March 24, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced positive 12-month data from the Phase 2 ArMaDa clinical trial evaluating OCU410 (AAV5-RORA), its novel modifier gene therapy for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD). The global prevalence of dAMD is 266 million worldwide, and GA affects approximately 2-3 million people in the United States (U.S.) and Europe. Importantly, this number is expected to increase significantly as populations age.
There are limited options for patients with dAMD in the U.S. and current therapies require 6–12 injections per year indefinitely, leading to substantial burden and significant dropout rates in real-world practice. Outside of the U.S., there are no approved products available.
Key findings from Phase 2 include:
31% reduction in lesion growth in the optimal dose (medium) group compared to control (p< 0.05)
27% slower rate of ellipsoid zone (EZ) loss compared to control, indicating structural preservation of photoreceptors, which correlates with visual function
55% of treated patients demonstrated ≥30% lesion size reduction vs. control
Subgroup analysis (subjects with baseline GA lesions ≥5 mm2 and ≤17.5 mm2) showed 33% reduction in lesion growth compared to control in medium dose OCU410 with similar reductions in the high dose group
The Phase 2 clinical trial builds directly on the clean safety profile observed in Phase 1 with no OCU410-related serious adverse events observed and no cases of endophthalmitis, retinal detachment, vasculitis, choroidal neovascularization, or ischemic optic neuropathy reported to date.
GA is a multifactorial disease with a complex etiology that involves genetic and environmental factors. The current treatment options for GA in the U.S. are limited to those targeting a single mechanism—the complement pathway. By contrast, OCU410 is a first-in-class RORA-based gene therapy designed to support central retina and photoreceptor integrity through a multi-pathway mechanism—targeting drusen, inflammation, oxidative stress, and complement activation.
“We have confirmed robust treatment effect from a well-controlled Phase 2 trial of a genetic medicine for GA. Now we can move on to Phase 3 with a high degree of confidence,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “This moves us one step closer to bringing a transformative one-time treatment to GA patients globally who are desperately seeking rescue from vision loss.”
“Our Phase 2 data consistently demonstrates statistically significant reduction of GA lesion growth after treatment with OCU410 optimal dose, and we continue to benchmark these results against natural history data to contextualize the magnitude of effect,” said Huma Qamar, MD, MPH, CMI, Chief Medical Officer of Ocugen. “We are incorporating these learnings into an anticipated Phase 3 pivotal confirmatory trial with up to 300 subjects and an adaptive design powered at over 95%.”
“There remains a considerable unmet need in treating patients with GA and I am encouraged by the various analyses of the Phase 2 OCU410 data,” said Lejla Vajzovic, MD, FASRS, Director, Duke Surgical Vitreoretinal Fellowship Program, Associate Professor of Ophthalmology with Tenure, Adult and Pediatric Vitreoretinal Surgery and Disease, Duke University Eye Center, and Chair, Ocugen Retina Scientific Advisory Board. “In addition to the strong efficacy and safety data, OCU410 has the potential to eliminate the chronic treatment burden associated with monthly or every-other-month intravitreal injections and to reduce treatment attrition driven by patient fatigue.”
In the Phase 2 study, the safety and efficacy of OCU410 in patients with GA secondary to dAMD are being assessed. Fifty-one (51) patients aged 50 years and older with GA lesions within the foveal or non-foveal region were randomized 1:1:1 to receive a single subretinal administration of OCU410 at a medium dose of 1 × 1010 vector genomes per eye, a high dose of 3 × 1010 vector genomes per eye, or no treatment in the control group; each injection volume was 200 microliters. Of note, choroidal neovascularization in the fellow eye was not exclusionary, and patients with prior exposure to pegcetacoplan or avacincaptad pegol were eligible following a three-month washout.
The primary endpoint was change in GA lesion size at 12 months, measured in square millimeters by fundus autofluorescence, an FDA-accepted structural endpoint used in recent GA registration trials. Exploratory endpoints included EZ preservation on OCT a key biomarker for photoreceptor integrity, which correlates with visual function.
Ocugen plans to initiate the OCU410 Phase 3 registrational trial in the third quarter of 2026 in line with the Company’s goal of three BLA filings in three years.
About dAMD and Geographic Atrophy Geographic atrophy is an advanced form of dAMD characterized by progressive degeneration of the macula, leading to irreversible central vision loss. Millions of patients worldwide are affected by GA, with a particularly high burden in aging populations in the United States and Europe. Despite recent approvals, treatment options remain limited and require chronic intravitreal injections, underscoring the need for innovative, durable therapies that address multiple disease mechanisms. dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula, the portion of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function, and central vision impairment. dAMD accounts for 85-90% of all AMD cases.
About OCU410 OCU410 is an investigational, subretinal injection, AAV5-based gene therapy that delivers RORA (retinoid-related orphan receptor alpha), a nuclear receptor that regulates key pathways involved in retinal homeostasis, including oxidative stress response, complement regulation, inflammation, and lipid metabolism. OCU410 is being developed as a one-time gene therapy for patients with GA secondary to dry AMD. OCU410 has received Advanced Therapy Medicinal Product (ATMP) classification from the European Medicines Agency.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at www.ocugen.com and follow us on X and LinkedIn.
Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU410 to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Monday, March 30: Phase 1 data on TNX-4800 (long-acting anti-Borrelia OspA human monoclonal antibody) for the seasonal prevention of Lyme disease
Wednesday, April 1: Animal and in vitro studies on TNX-801 (horsepox, live virus vaccine) for the prevention of smallpox and mpox
Wednesday, April 1: Horsepox as a modular antigen-delivery system for broad and sustained immunity in novel vaccines to protect against other pathogens
BERKELEY HEIGHTS, N.J., March 23, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced an oral presentation of Phase 1 data on TNX-4800 (formerly known as mAb 2217LS)1,2, a long-acting human monoclonal antibody (mAb) that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the causative agent of Lyme disease in humans in the U.S., at the World Vaccine Congress Washington 2026 held in Washington, D.C., March 30-April 2, 2026.
The Company’s Farooq Nasar, PhD, Director, Virology will present data on TNX-801, the Company’s attenuated, live orthopoxvirus (horsepox) vaccine candidate with the potential capability to protect against smallpox and mpox. Finally, Christopher Cooper, PhD, Director, Immunology at Tonix will serve as moderator on a panel discussing modular antigen-delivery systems in novel pox-based vaccines.
TNX-4800 Presentation Details
Title: A Long-Acting Monoclonal Antibody for Seasonal Prevention of Lyme Disease Location: Room 202B Date and Time: March 30, 2026, 10:10 a.m. ET Session Category: Measuring Breadth & Emerging Targets Presenters: Mark S. Klempner, MD, Professor of Medicine at UMass Chan Medical School, inventor of TNX-4800, and Principal Investigator of the study
Other Session Details
Title: A Live Attenuated, Minimally Replicative MPOX Vaccine Location: Room 202A, Level 2 Date and Time: April 1, 2026, 10:10 am ET Session Category: Emerging & Re-Emerging Diseases Presenter: Farooq Nasar, PhD, Director, Virology, Research and Development Center (RDC), Tonix Pharmaceuticals
Title: Poxvirus as a Modular Antigen-Delivery System for Broad and Sustained Immunity Location: Room 20A, Level 2 Date and Time: April 1, 2026, 3:25 p.m. ET Session Category: Emerging & Re-Emerging Diseases Moderator: Christopher Cooper, PhD, Director, Immunology, RDC, Tonix Pharmaceuticals
About TNX-4800 TNX-4800 (formerly known as mAb 2217LS) is a human monoclonal antibody with an engineered extended half-life that targets the outer-surface protein A (OspA) on Lyme-causing Borrelia bacteria. When TNX-4800-containing blood is ingested by the tick, TNX-4800 kills and blocks the maturation of Borrelia burgdorferi in the mid-gut of infected deer ticks. The Company in-licensed TNX-4800 from UMass Chan Medical School in 2025. Published work in animals showed that TNX-4800 was 95% effective in preventing infection after a six-day challenge with ticks infected with Borrelia burgdorferi.1 TNX-4800 was derived from mAb 2217 by amino acid substitutions in its crystallizable fragment (Fc) domain which serve to prolong the serum half-life. A single administration in the Spring is designed to potentially provide immunity within two days and maintain protective antibody titers for the entire tick season, providing pre-exposure prophylaxis against Lyme disease without relying on the recipient’s immune system to generate antibodies. By delivering a well-characterized antibody directly, TNX-4800 has been shown to block transmission of Borrelia burgdorferi from ticks to animals. TNX-4800 also sidesteps the multidose schedules required for OspA vaccines in development3 and the FDA-approved vaccine that was withdrawn from the market.4 The Company expects to have GMP investigational product available for clinical testing in early 2027. Pending FDA clearances, a field study is expected to initiate enrollment in the first half of 2027, and a controlled human infection model (CHIM) study in 2028.
About the TNX-4800 Phase 1 Study TNX-4800 was studied in a randomized, double-blind, sequential dose-escalation study (NCT04863287) that evaluated safety, tolerability, pharmacokinetics (PK), and immunogenicity of TNX-4800 in healthy adults. 44 subjects were randomized, and 41 completed the study. Subjects received a single subcutaneous (SC) administration of placebo or TNX-4800 at 0.5, 1.5, 5, or 10 mg/kg. Safety was assessed via clinical and lab evaluations. Drug exposure increased by approximately 25 times for a 20 times increase in dose. Serum TNX-4800 was measurable at the earliest sampling time of 24 hours, indicating rapid systemic absorption. TNX-4800 concentrations remained quantifiable for >200 days in 80% of volunteers at the lowest dose and for up to 350 days in the majority of volunteers at higher doses (i.e., ≥ 1.5 mg/kg). Mean half-life ranged from 62-69 days across groups. Serum concentrations remained quantifiable for up to 12 months in most subjects. Mean exposure for the 10 mg/kg cohort was less than 20% of the highest exposures in a rat toxicology study. Anti-drug antibodies (ADA) were detected in <10% of treated subjects, with no impact on PK. Most adverse events were mild or moderate. TNX-4800 was determined to be generally safe and well tolerated.
About Lyme Disease In the United States, Lyme disease is caused by the bacterium Borrelia burgdorferi. Lyme disease remains the most common vector-borne infection in the United States, and its incidence is climbing each year, due in part to global changes in climate expanding the habitat range for ticks.5 It occurs most commonly in the Northeast, mid-Atlantic, and upper-Midwest regions. Lyme disease bacteria are transmitted through the bite of infected Ixodes ticks. Typical symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, heart, and nervous system. Laboratory testing is helpful if used correctly and performed with FDA-cleared tests. Although many cases of Lyme disease can be treated successfully with antibiotics, diagnosis and treatment are often delayed or missed. Chronic Lyme is considered an Infection Associated Chronic Illness (IACI), and is a chronic, debilitating disease state characterized by joint and muscle pain, fatigue, and other symptoms.6
About TNX-801 TNX-801 (recombinant horsepox virus) is an attenuated, minimally replicative, live virus vaccine based on horsepox in pre-clinical development to prevent mpox and smallpox. TNX-801 is expected to enter a Phase 1 study in 2027 pending FDA clearance. TNX-801 is in the pre-IND stages of development.
Citations 1Schiller ZA, et al. J Clin Invest. 2021 131(11):e144843. 2Wang Y, et al. J Infect Dis. 2016. 214(2):205-11. 3Comstedt P, et al. Vaccine. 2015 33(44):5982-8. 4Connaught’s (ImuLyme™) and SmithKline Beecham’s (LYMErix™) Lyme disease vaccines were withdrawn. Nigrovic LE, et al. Epidemiol Infect. 2007 135(1):1-8. doi: 10.1017/S0950268806007096. Epub 2006 Aug 8. PMID: 16893489; PMCID: PMC2870557. 5Gomes-Solecki M, et. al. Clin Infect Dis. 2020 70(8):1768-1773. doi: 10.1093/cid/ciz872. PMID: 31620776; PMCID: PMC7155782. 6National Academies of Sciences, Engineering, and Medicine. 2025. Charting a Path Toward New Treatments for Lyme Infection-Associated Chronic Illnesses. Washington, DC: The National Academies Press. https://doi.org/10.17226/28578.
Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals* is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg), is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. In addition, the Company’s CNS portfolio includes TNX-2900 (intranasal oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including long-acting human monoclonal antibody TNX-4800 for Lyme disease prophylaxis, and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.
*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially as a result of a number of factors, including the ability of the Company to satisfy the conditions to the closing of the offering and the timing thereof, as well as those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
MALVERN, Pa., March 23, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it will host a conference call and live webcast with key opinion leaders (KOLs) and Ocugen executive leadership to discuss the full data set from the Phase 2 ArMaDa clinical trial evaluating OCU410 for geographic atrophy (GA), late-stage dry age-related macular degeneration (dAMD) at 8 a.m. EDT on Tuesday, March 24, 2026.
KOLs leading the webcast include:
Lejla Vajzovic, MD, FASRS, Professor of Ophthalmology, Director of CME-Ophthalmology, Duke University School of Medicine & Chairman, Ocugen Scientific Advisory Board
Jay Chhablani, MD, Professor, University of Pittsburgh and UPMC Vision Institute, and President of NetraMind
Victor H. Gonzalez, MD, Retinal Surgeon, Valley Retina Institute, McAllen, Texas, Faculty at University of Texas Rio Grande Valley; and Syed M. Shah, MD, Vice Chair for Research and Digital Medicine, Director of Retina Service, Department of Ophthalmology at Emplfiy Health, La Crosse, WI, Ibn al-Haytham Professor, Department of Ophthalmology, Aga Khan University will join to answer questions.
Attendees are invited to participate on the call using the following details:
Dial-inNumbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers ConferenceID: 4629682 Webcast: Available on the events section of the Ocugen investorsite
A replay of the call and archived webcast will be available following the event on the Ocugen investorsite.
AboutOcugen,Inc. Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X and LinkedIn.
CautionaryNoteonForward-LookingStatements Thispressreleasecontainsforward-lookingstatementswithinthemeaningofThePrivateSecuritiesLitigationReformActof1995,whicharesubject to risks and uncertainties. We may,insomecases,usetermssuchas“predicts,”“believes,”“potential,”“proposed,”“continue,”“estimates,” “anticipates,”“expects,”“plans,”“intends,”“may,”“could,”“might,”“will,”“should,”orotherwordsthatconveyuncertaintyoffutureeventsoroutcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actualeventsorresultstodiffermateriallyfromourcurrentexpectations.Theseandotherrisksanduncertaintiesaremorefullydescribedinour periodicfilingswiththeSecuritiesandExchangeCommission(SEC),includingtheriskfactorsdescribedinthesectionentitled“RiskFactors”inthe quarterlyandannualreportsthatwefilewiththeSEC.Anyforward-lookingstatementsthatwemakeinthispressreleasespeakonlyasofthedateof thispressrelease.Exceptasrequiredbylaw,weassumenoobligationtoupdateforward-lookingstatementscontainedinthispressreleasewhether as a result of new information, future events, or otherwise, after the date of this press release.
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.
Tegoprubart Trials To Advance In FY2026. Eledon reported a 4Q loss of $10.4 million or $(0.11) per share and a FY2025 loss of $45.6 million or $(0.52) per share. The FY Total Operating Expenses were $83.3 million, with non-cash items (including changes in the fair value of warrant liabilities) of $33.4 million. Net Loss excluding these items would have been $79.1 million for full year. Updates for tegoprubart clinical development were also confirmed with the announcement. Cash on December 31, 2025 was $45.6 million.
Clinical Trials In Transplantation Have Several Milestones Ahead.Eledon expects to meet with the FDA to discuss plans for a Phase 3 tegoprubart trial for prevention of kidney transplant rejection. We expect the guidance to clarify required endpoints and could lead to the start of Phase 3 by year-end. Guidance is also expected for Islet cell transplantation in diabetes and xenotransplantation.
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SAN DIEGO, March 20, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that the Company will host a key opinion leader (KOL) webinar to discuss the emergent treatment landscape in first-line RAS-mutated metastatic colorectal cancer (mCRC). The webinar will take place on Wednesday, March 25th, 2026, at 4:30 p.m. ET.
The webinar will feature KOLs Scott Kopetz, M.D., Ph.D., FACP and Heinz-Josef Lenz, M.D., who will join Mani Mohindru, PhD, interim Chief Executive Officer, to discuss onvansertib’s existing clinical data and its potential as a novel therapeutic approach in the management of mCRC.
About the KOLs
Scott Kopetz, M.D., Ph.D., FACP, is a Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center and an internationally recognized leader in colorectal cancer research and translational oncology. Dr. Kopetz’s work has helped establish new treatment approaches for molecularly defined colorectal cancers, including therapies targeting BRAF-mutated metastatic disease. He serves in multiple national leadership roles supporting gastrointestinal cancer research and clinical trial development and has led numerous Phase I–III clinical studies focused on improving outcomes for patients with GI malignancies. His research integrates molecular profiling and translational science to advance precision medicine strategies and overcome treatment resistance in colorectal cancer.
Heinz Josef-Lenz, M.D., is a University Professor of Medicine, Population and Public Health Sciences and Cancer Biology; Professor of Medicine and Preventive Medicine of USC. He serves as Co-Leader of the Gastrointestinal Cancers Program and Co-Director of the USC Center for Cancer Drug Development. Dr. Lenz’s research focuses on molecular mechanisms of cancer development, drug resistance, and biomarker-driven treatment approaches in gastrointestinal cancers, including colorectal cancer. He has authored numerous peer-reviewed publications and holds leadership roles across national oncology research initiatives, including service on National Cancer Institute committees and cooperative clinical trial groups guiding translational and clinical research in GI oncology.
KOL Webinar Information
Interested parties can register for and access the live webcast by visiting the “Events” section of the Cardiff Oncology website. The webcast replay will be available after the conclusion of the discussion.
About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (“mCRC”), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.
Reported updated results from 12 patients with type 1 diabetes treated with tegoprubart following islet transplantation in UChicago Medicine-led study
Presented 24-month follow-up data from Phase 1b long-term extension study which continues to support the favorable safety and tolerability profile of tegoprubart
Tegoprubart granted Orphan Drug designation by the FDA for the prevention of allograft rejection in liver transplantation
IRVINE, Calif., March 19, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2025 operating and financial results and reviewed recent business highlights.
“Over the past year, Eledon has made significant progress advancing tegoprubart, our anti-CD40L antibody, as a potential next-generation immunosuppressive therapy across multiple transplantation settings,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The over 100 patients treated across our transplantation programs to date provide a growing body of evidence that reinforces our conviction that tegoprubart can address key safety and efficacy issues with current standard-of-care transplant immunosuppression. Looking ahead, we anticipate multiple important milestones this year, including regulatory engagement to support advancement into Phase 3 development in kidney transplantation, initiation of an additional islet transplantation trial in type 1 diabetes, and the start of a clinical trial in liver transplantation.”
Fourth Quarter 2025 and Recent Corporate Developments
Announced that tegoprubart has been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) for the prevention of allograft rejection in liver transplantation. Tegoprubart previously received Orphan Drug designation from the FDA for the prevention of allograft rejection in pancreatic islet cell transplantation and for the treatment of amyotrophic lateral sclerosis (ALS).
Presented 24-month follow-up data from eight patients enrolled in the Phase 1b long-term extension trial evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium. The data continue to support the favorable safety and tolerability profile of tegoprubart with no episodes of biopsy-proven acute rejection, graft loss, death, new-onset diabetes mellitus, or de novo donor-specific antibody formation reported during the study period. Mean estimated glomerular filtration rate (eGFR) increased over the measurement period, from 67.0 mL/min/1.73 m² at 12 months to 74.2 mL/min/1.73 m² at 24 months.
Reported updated results from 12 patients with type 1 diabetes treated with tegoprubart as the core immunosuppressant following islet transplantation in an investigator-initiated trial conducted at the University of Chicago Medicine Transplant Institute. All 10 patients who were more than four weeks post-transplant achieved 100% insulin independence and a most recent hemoglobin A1C (HbA1c) below 6.0%, with a mean most recent HbA1c across the 10 patients of approximately 5.35%. Tegoprubart-based immunosuppression was generally well tolerated with reported post-transplant immunosuppression-related adverse events successfully treated by lowering the mycophenolic acid dose, if necessary. There were no rejection episodes, and no patients developed de novo donor-specific HLA antibodies. Additionally, no evidence of nephrotoxicity, hypertension or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, was observed. The study continues to generate significant patient demand with inquiries received from several hundred T1D patients.
Anticipated Upcoming Milestones
Receive FDA guidance on the Phase 3 trial design assessing tegoprubart in kidney transplantation, followed by initiation of the Phase 3 trial pending regulatory alignment.
Report long-term data from Phase 1 and Phase 2 BESTOW studies evaluating tegoprubart in kidney transplantation.
Receive FDA regulatory guidance on path to market for tegoprubart in islet cell transplantation and xenotransplantation.
Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients with renal dysfunction receiving an islet cell transplant.
Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo liver transplant.
Initiate an investigator-led study evaluating tegoprubart for kidney transplant tolerance induction.
Full Year 2025 Financial Results
Research and development (R&D) expenses for the year ended December 31, 2025 were $66.3 million, including $4.2 million of non-cash stock-based compensation expense, compared to $52.0 million, including $4.3 million of non-cash stock-based compensation expense, for the comparable period in 2024. The increase was primarily driven by continued advancement of the tegoprubart clinical development programs, including expanded clinical trial activity and manufacturing scale-up, as well as increased personnel to support these efforts.
General and administrative expenses for the year ended December 31, 2025 were $17.0 million, including $6.2 million of non-cash stock-based compensation expense, compared to $18.6 million, including $8.8 million of non-cash stock-based compensation expense, for the comparable period in 2024. The decrease was primarily driven by lower stock-based compensation expense, partially offset by higher professional services and personnel-related costs.
Net loss for the year ended December 31, 2025 was $45.6 million, or $0.52 per basic share of common stock, compared to a net loss of $36.2 million, or $0.66 per basic share of common stock, for the comparable period in 2024. The 2025 net loss included a non-cash gain of $33.4 million from changes in the fair value of warrant liabilities, while the 2024 net loss included a non-cash gain of $30.9 million from such changes. Excluding the non-cash items related to changes in the fair value of warrant liabilities, Eledon would have recorded a net loss of $79.1 million for the year ended December 31, 2025 and $67.1 million for the year ended December 31, 2024.
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-CD40 Ligand 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. 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 in 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 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 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.
STAFFORD, Texas, March 19, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the initiation of new clinical sites in the US.
The Phase III clinical trial has recently been activated at City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States – specifically at its network sites in Los Angeles and Orange counties, Arizona, Atlanta, and Illinois. Principal investigator at City of Hope, Hope S. Rugo, M.D., continues her participation on the Steering Committee. Her prior site at University of California San Francisco, where she is Professor Emeritus, is still participating in the study.
Dr. Rugo is division chief of breast medical oncology and a professor in the Department of Medical Oncology & Therapeutics Research at City of Hope. She also serves as director of the Women’s Cancers Program for City of Hope’s national network of cancer centers. A world-renowned expert in breast cancer and clinical trial design and execution, Dr. Rugo oversees women’s cancer research initiatives and clinical care at City of Hope. She is focused on expanding breast cancer clinical trials, advancing translational research, and standardizing care to improve patient outcomes. She is deeply committed to improving access to innovative new therapies for breast cancer patients everywhere and takes a compassionate, collaborative approach in her work.
Dr. Rugo has been directly involved in numerous projects that have established new standards of care for breast cancer. She has served on the steering committees of multiple clinical trials that led to the approval of agents such as PARP inhibitors, CDK4/6 inhibitors, PI3K inhibitors, checkpoint inhibitors, and antibody-drug conjugates, among others. Additionally, Dr. Rugo has led several studies aimed at minimizing therapy-related toxicity. She also served as co-chair of the Triple Negative Working Group of the Translational Breast Cancer Research Consortium, where she spearheaded groundbreaking multicenter clinical trials in collaboration with researchers, pharmaceutical companies, and clinical providers. As a physician-scholar with more than 500 peer-reviewed publications, Dr. Rugo served on the editorial board of the American Society of Clinical Oncology’s Education Committee, which included co-chairing the creation of new guidelines for the hormonal treatment of metastatic breast cancer.
Dr. Rugo commented, “I am excited to open this important trial across our City of Hope sites, expanding treatment opportunities for our patients with high-risk early stage HER2 positive breast cancer. It is truly an honor to now represent City of Hope on the Steering Committee. This study aligns with City of Hope’s interest in and the importance of harnessing the host immune system to reduce the risk of breast cancer recurrence.”
Last year City of Hope launched a national clinical trials model that includes clinical sites across the United States in order to accelerate cancer research.
Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, “We are honored to have Dr. Rugo, a globally recognized leader in breast cancer, now participating in FLAMINGO-01 through her leadership at City of Hope. Her site’s expertise and commitment to advancing patient care, which I personally experienced when training these sites, is invaluable as we continue to study GLSI-100. The four City of Hope locations also strengthen our study footprint in some regions of the US where we were not previously covered, providing the study with access to additional population centers.”
CEO Snehal Patel commented, “We started working with Dr. Rugo when she was the breast cancer leader at UCSF and joined our Phase III study and Steering Committee. We quickly benefited from her recommendations as the study was starting up and expanding into Europe. Her extensive experience in developing novel therapies, while minimizing toxicities, will guide us through the development of GLSI-100 as an effective and safe vaccine to prevent metastatic breast cancer in high-risk breast cancer survivors. With the addition of these new sites at City of Hope, planned expansion of US Oncology/Sarah Cannon sites, addition of sites in new countries, including potentially the United Kingdom and Canada, the total sites participating in FLAMINGO-01 could increase from the current 160 sites to up to 190-200 sites.”
About FLAMINGO-01 Open Label Phase III Data
More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.
In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.
About GLSI-100 Phase IIb Study
In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:
80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
Investor & Public Relations Contact for Greenwich LifeSciences Dave Gentry RedChip Companies Inc. Office: 1-800-RED CHIP (733 2447) Email: dave@redchip.com
Preclinical results in therapy-resistant HER2-low breast cancer models demonstrate enhanced antitumor activity and reversal of resistance with PLK1 inhibition
SAN DIEGO, March 19, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that new preclinical data highlighting the potential of its highly specific oral PLK1 inhibitor, onvansertib, in combination with trastuzumab deruxtecan (T-DXd) will be presented at the American Association for Cancer Research Annual Meeting 2026, taking place April 17-22, 2026 in San Diego, California.
The poster presentation will showcase findings demonstrating that onvansertib enhanced the antitumor activity of T-DXd and reversed resistance in therapy-resistant HER2-low breast cancer models.
Poster Presentation Details:
Title:PLK1 inhibitor onvansertib potentiates the antitumor efficacy of trastuzumab deruxtecan (T-DXd) and reverses its resistance in therapy-resistant HER2-low breast cancer models
Date & Time: April 19, 2026 | 2:00 PM – 5:00 PM PT
Abstract Number: 329
The poster will be made available on the Scientific Publications page of the Company’s website following the presentation.
About Onvansertib Onvansertib is a highly specific, oral PLK1 inhibitor currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer. It is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).
About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (“mCRC”), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.
The Company recently announced an exclusive distribution agreement with Innomedica CCB S.A. for its Kinesiology Line, AVERSA products and Mosquito repellent patches
ORLANDO, Fla., March 18, 2026 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ: NTRB) (NASDAQ: NTRBW) today announced that The Costa Rica Ministry of Health has approved the Company’s line of Kinesiology Tapes for import and Sale. Innomedica CCB, the company’s exclusive distribution partner for Costa Rica oversaw and financed the regulatory approval process.
The Company, partnering with Innomedica plans to begin ramping up marketing efforts for these products and its mosquito repellant patch line following this latest approval.
About AVERSA™ Abuse-Deterrent Transdermal Technology
Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, including opioids and stimulant drugs, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
About Nutriband Inc.
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s periodic and current reports on Form 10-K, Forms 10-Q and 8-K and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
