Biotechnology Archives

Release – Eledon Pharmaceuticals Reports First Quarter 2026 Financial Results and Recent Business Highlights

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

May 13, 2026

100% insulin independence achieved in 10 patients with type 1 diabetes treated with tegoprubart following islet transplantation in UChicago Medicine-led study

FDA Orphan Drug designation granted to tegoprubart for the prevention of allograft rejection in liver transplantation

Cash, cash equivalents and short-term investments totaled $111.1 million as of March 31, 2026

IRVINE, Calif., May 13, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its first quarter 2026 operating and financial results and provided recent business highlights.

“In the first quarter of 2026, we achieved significant milestones in our tegoprubart program, including important data updates in kidney and islet cell transplantation and FDA Orphan Drug designation for tegoprubart in liver transplantation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Looking ahead, we expect multiple catalysts in 2026, including regulatory engagements supporting the advancement of tegoprubart into Phase 3 development in kidney transplantation and discussions regarding a potential path to market in islet cell transplantation. We also plan to initiate several new clinical trials, including an investigator sponsored study in liver transplantation, and share new kidney transplant data from our Phase 2 BESTOW long-term extension study, building on encouraging 24-month Phase 1b results that demonstrated a durable safety profile and improved graft function.”

First Quarter 2026 Business Highlights

In March 2026, announced updated results from an ongoing investigator-led trial at the University of Chicago Medicine Transplant Institute evaluating tegoprubart in 12 adults with high-risk type 1 diabetes undergoing allogenic islet transplantation. All 10 patients who are more than four weeks post-transplant achieved 100% insulin independence. There were no signs of graft rejection or de novo donor-specific HLA antibodies and no evidence of nephrotoxicity, hypertension, or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, the current standard of care.
The U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to tegoprubart for the prevention of allograft rejection in liver transplantation.
Presented 24-month follow-up data from eight patients enrolled in the Phase 1b trial long-term extension trial evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium in January 2026. Results showed there were no episodes of biopsy-proven acute rejection, graft loss, death, new-onset diabetes mellitus, or de novo donor-specific antibody formation 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.

2026 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 1b and Phase 2 BESTOW studies evaluating tegoprubart in kidney transplantation.
Receive FDA regulatory guidance on the 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.

First Quarter 2026 Financial Results

Cash, cash equivalents and short-term investments totaled $111.1 million as of March 31, 2026, compared to $133.3 million as of December 31, 2025. The company expects current cash, cash equivalents and short-term investments to fund operations into 2Q 2027.

Research and development (R&D) expenses for the first quarter of 2026 were $17.2 million, including $1.1 million of non-cash stock-based compensation expense, compared to $13.5 million, including $1.0 million of non-cash stock-based compensation expense, for the comparable period in 2025.

General and administrative (G&A) expenses for the first quarter of 2026 were $4.0 million, including $1.1 million of non-cash stock-based compensation expense, compared to $4.4 million, including $1.8 million of non-cash stock-based compensation expense, for the comparable period in 2025.

Net loss for the first quarter of 2026 was $39.0 million, or $0.33 per basic common share, compared to a net loss of $6.5 million, or $0.08 per basic common share, for the comparable period in 2025. Net loss in the first quarter of 2026 included a non-cash loss of $19.0 million from changes in the fair value of warrant liabilities, while the 2025 net loss included a non-cash gain of $10.1 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 $20.1 million for the three months ended March 31, 2026, and $16.6 million for the three months ended March 31, 2025.

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; X

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.

Investor Contact:

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

Media Contact:

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

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Unicycive Therapeutics (UNCY) – 1Q26 Reported With OLC On Schedule For June 2026 Approval

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

Wednesday, May 13, 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.

First Quarter Operating Loss Was Lower Than Our Estimates. Unicycive reported a 1Q Loss From Operations of $8.0 million, compared with our estimate of $9.9 million. An increase of $8.3 million in the Fair Value of Warrant Liabilities resulted in a Net Comprehensive Loss attributable to common shareholders of $12.8 million, or $(0.54) per share. Importantly, the company confirmed that NDA approval for OLC is on track to meet the June 29 PDUFA date. Cash on March 31, 2026, was $57.1 million.

We Expect OLC Approval By The PDUFA Date. The NDA for OLC (oxylanthanum calcium) was submitted in December and accepted for review in January. We believe the preclinical and clinical sections have already passed FDA review, and previous manufacturing problems associated with a contract manufacturer have been corrected. We expect OLC to receive FDA approval on or before its June 29, 2026, approval date.

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

Release – Tonix Pharmaceuticals Reports First Quarter 2026 Financial Results and Operational Highlights

Posted on May 11, 2026May 12, 2026 by [email protected]

Research News and Market Data on TNXP

May 11, 2026 4:30pm EDT Download as PDF

In the first full quarter since launch, 2,145 healthcare providers prescribed TONMYA^®, 3,588 patients initiated treatment, and ~5,400 prescriptions were filled

Agreement signed in May with leading group purchasing organization (GPO) that provides access to TONMYA for approximately 35 million U.S. commercial lives

Expect to initiate adaptive Phase 2 field study for the prevention of Lyme disease in the U.S. in the first half of 2027 for TNX-4800, pending FDA agreement

Approximately $185.5 million in cash and cash equivalents as of March 31, 2026

BERKELEY HEIGHTS, N.J., May 11, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced financial results for the quarter ended March 31, 2026, and provided an overview of recent operational highlights.

“TONMYA is the first new fibromyalgia medicine in 15 years,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TONMYA is a non-opioid analgesic designed for bedtime administration and long-term use by adults. Since launch in November 2025, TONMYA has shown growth in prescriptions, new writers, refills, and patient access. Our first managed care partnership was announced in May, providing access to approximately 35 million U.S. commercial lives. We will continue engagement with commercial and government payers to expand patient access. Our focus remains on operational excellence across sales, marketing, medical affairs, and market access to educate and deliver on TONMYA’s differentiated potential.”

Dr. Lederman continued, “We also continue to meaningfully advance our mid-stage clinical programs and our earlier-stage pipeline. For TNX-4800, our investigational long-acting borreliacidal, human monoclonal antibody targeting OspA on Borrelia burgdorferi, which causes the majority of Lyme disease in the U.S., we announced positive Phase 1 data and plans for an adaptive Phase 2 field study in 2027, pending FDA agreement. We look forward to our scheduled Type C meeting with the FDA early in the third quarter of 2026 to discuss the study. We believe TNX-4800 offers several advantages over vaccines in development, including onset of protection within two days and a simpler two-dose regimen with a second booster dose two months after the first. We also expect to begin our Phase 2 study of TONMYA for the treatment of Major Depressive Disorder (MDD) mid-year. Our other programs across CNS, infectious disease, immunology, and rare disease remain well positioned for near-term milestones.”

Commercial Updates

TONMYA (cyclobenzaprine HCl sublingual tablets): a centrally acting, non-opioid analgesic for the treatment of fibromyalgia in adults

On November 17, 2025, TONMYA became commercially available, following U.S. FDA approval in August 2025 for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. The approval was based on two double-blind, randomized, placebo-controlled Phase 3 clinical studies of nearly 1,000 patients that demonstrated durable and statistically significant reduction in daily pain scores compared to placebo. There are now approximately 100 TONMYA sales reps in the field.
In the first quarter of 2026, the first full quarter since launch, key metrics include:
- 2,145 unique healthcare providers prescribed TONMYA to patients.
- 3,588 unique patients initiated treatment with TONMYA.
- Approximately 5,400 prescriptions were filled. This includes bridge prescriptions that are facilitated through the Company’s specialty pharmacy channel. Bridge prescriptions represent initial patient fills provided while coverage determinations are pending and do not immediately generate net product revenue.
For the period beginning November 17, 2025, through April 24, 2026, cumulative key metrics include:
- More than 2,700 unique healthcare providers have prescribed TONMYA to patients.
- Approximately 5,618 unique patients have initiated treatment with TONMYA.
For the period beginning November 17, 2025, through May 1, 2026, cumulative key metrics include:
- Approximately 11,016 prescriptions were filled. This includes bridge prescriptions that are facilitated through the Company’s specialty pharmacy channel.
Repeat prescriber and patient refill trends are encouraging.
The Company is prioritizing engagement with commercial payers, Medicare, and Medicaid to increase access:
- In May 2026, Tonix secured commercial payer coverage with its first managed care partnership agreement with a leading GPO, which will provide access for approximately 35 million U.S. patients (20% of ~177 million commercial lives in the U.S.)
- To date, TONMYA is covered under Medicaid in 38 states, for approximately 55 million lives, representing 73% of the roughly 75 million Medicaid lives.
Tonix has a robust patient access program and support services in place, including a TONMYA savings card, copay assistance, and prior authorization support, intended to reduce access barriers during early commercialization.
To educate healthcare providers (HCPs), the Company held a multidisciplinary dialogue about TONMYA via a national webcast. Tonix also launched a national speaker training program with approximately 100 HCPs to maximize peer-to-peer speaker programs expected to occur across target specialties and regions this year.
As part of a commitment to continued clinical evidence generation and education, Tonix presented clinical data on TONMYA at the 8^th International Congress on Controversies in Fibromyalgia, 2026 American Academy of Pain Medicine (AAPM) PainConnect Annual Meeting, and 2026 Non-Opioid Pain Therapeutics Summit. The Company also published two articles in the peer-reviewed journal, Clinical Pharmacology in Drug Development.

Key Product Pipeline Candidates: Recent Highlights

Central Nervous System (CNS) Pipeline

TNX-102 SL (cyclobenzaprine HCl sublingual tablets): in Phase 2 development for MDD; remains on track to initiate mid-year 2026

In November 2025, the FDA cleared the IND for TNX-102 SL 5.6 mg for the treatment of MDD in adults. The IND clearance enables Tonix to proceed with the HORIZON study, a potentially pivotal Phase 2, 6-week, randomized, double-blind, placebo-controlled study of TNX-102 SL as a first-line monotherapy in adults with MDD. About 360 patients will be enrolled at approximately 30 U.S. sites, with the primary endpoint being the MADRS total score change from baseline at Week 6. Tonix plans to initiate enrollment in mid-2026.

TNX-102 SL in Phase 2 development for the treatment of acute stress disorder (ASD) and acute stress reaction (ASR)

The U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions (OASIS) study is being conducted by the University of North Carolina under an investigator-initiated IND. The OASIS study examines the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients in the emergency department after a motor vehicle collision. Topline data is expected to be reported in the second half of 2026.

TNX-1300 (double-mutant cocaine esterase) for cocaine intoxication; Phase 2-program has Breakthrough Therapy designation from the FDA, with no products on the market for this indication

The Company plans to meet with the FDA in 2026 to inform the clinical design of the next Phase 2 study (a Phase 2a study has been completed).

TNX-1900 (intranasal potentiated oxytocin): in development for several CNS disorders

TNX-1900 is currently being studied in four Phase 2 and one Phase 1 investigator-initiated studies. The Phase 2 investigator-initiated studies include binge-eating disorder (Massachusetts General Hospital, “MGH”), adolescent obesity (MGH), bone health in autism (MGH and University of Virgina), and arginine vasopressin deficiency (MGH).
In March 2026, Tonix announced the dosing of the first participant in a Phase 1 investigator-initiated pharmacodynamic study with Erasmus University of TNX-1900 in healthy female volunteers, using capsaicin and electrical stimulation to model trigeminal neurovascular reactivity.

Infectious Disease Pipeline

TNX-4800 (anti-OspA mAb): Phase 2-ready long-acting human monoclonal antibody in development for the seasonal prevention of Lyme disease in the U.S., which has no FDA-approved vaccines or prophylactics

In March 2026, Tonix presented Phase 1 data at the World Vaccine Congress Washington 2026 and announced plans to initiate an adaptive Phase 2 field study in the first half of 2027, pending FDA agreement. The Company also presented Phase 1 data in April 2026 at the 4^th Annual Ticks and Tickborne Diseases Symposium at Johns Hopkins University.
- TNX-4800 demonstrated encouraging safety, tolerability, pharmacokinetics, and immunogenicity, with serum TNX-4800 measurable at the earlier sampling time of 48 hours and no significant clinical or laboratory safety signals. The Phase 1 study was conducted by a team at UMass Chan Medical School led by Mark S. Klempner, MD, Professor of Medicine at UMass Chan and an inventor of TNX-4800.
In April 2026, the Company announced it expects to lead a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study to evaluate the efficacy of a two-dose regimen of TNX-4800 subcutaneous (SC) in preventing the first occurrence of confirmed Lyme disease during the primary efficacy surveillance period (Day 3 through Month 6 following administration). Each fixed dose is expected to provide exposures comparable to the 5 mg/kg dose evaluated in Phase 1. The first dose will be administered in the Spring and the second booster dose will be administered two months later. Participants will include adolescents and adults 16 years of age and older in Lyme-endemic areas in the U.S. The primary endpoint will be the prevention of Lyme disease for six months (comparison of TNX-4800 group and placebo group) following the initial dose.
In April 2026, the Company announced it has scheduled a Type C meeting with the FDA early in the third quarter of 2026 to discuss the planned adaptive Phase 2 field study design.
The Company expects to have GMP investigational product available for clinical testing in early 2027.

TNX-801 (recombinant horsepox virus): attenuated, pre-clinical live orthopoxvirus vaccine candidate for the prevention of smallpox and mpox

In March 2026, Tonix presented animal and in vitro data on TNX-801 at the World Vaccine Congress Washington 2026. TNX-801 is expected to enter a Phase 1 study in 2027 pending FDA clearance of the Investigational New Drug (IND) application.

TNX-4200 (small molecule): broad spectrum anti-viral to protect against viral diseases

TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments.
The TNX-4200 program is supported by an up to $34 million contract over five years from the Department of Defense’s Defense Threat Reduction Agency (DTRA). In the first quarter of 2026, the Company received confirmation that the project was cleared to enter the next budgetary and developmental phase.

Immunology Pipeline

TNX-1500 (dimeric Fc modified anti-CD40L, humanized mAb): Phase 2-ready third generation anti-CD40L for prophylaxis of kidney transplant rejection and treatment of autoimmune disorders

In November 2025, Tonix announced a collaboration with MGH to advance a Phase 2, open-label, investigator-initiated clinical study of TNX-1500 in kidney transplant recipients, planned for initiation mid-year 2026, pending FDA clearance of the IND. The study is expected to enroll five adult kidney transplant recipients.

Rare Disease Pipeline

TNX-2900 (intranasal potentiated oxytocin): in development for Prader-Willi syndrome, with Orphan Drug designation as well as Rare Pediatric Disease designation that could make Tonix eligible for a Priority Review Voucher upon approval

In September 2025, Tonix announced plans to initiate a Phase 2, randomized, double-blind, placebo-controlled study in children and adolescents with Prader-Willi syndrome. The study is expected to initiate in the first quarter of 2027.

Immuno-oncology Pipeline

TNX-1700 (TFF2-albumin fusion protein): in preclinical development for gastric and colorectal cancer

In March 2026, Tonix presented preclinical data at the American Association for Cancer Research (AACR) Annual Meeting 2026. Data presented in an oral presentation showed how TNX-1700 reversed aging-associated gastric inflammation and significantly attenuated tumor progression in an aged gastric microenvironment in preclinical models. Data in a poster presentation demonstrated TNX-1700 exhibited dose-independent, linear pharmacokinetics in animals.

TNX-4700 (human anti-BTLA mAb): in preclinical development for immuno-oncology indications

In March 2026, Tonix presented preclinical data in a poster presentation at the AACR Annual Meeting 2026 demonstrating TNX-4700 demonstrated potent, high-affinity binding and functional antagonism. The mAb technology was licensed from Curia.

Financial: Recent Highlights

Tonix had approximately $185.5 million of cash and cash equivalents as of March 31, 2026, compared to approximately $207.6 million as of March 31, 2025. Net cash used in operations was approximately $42.3 million for the first quarter ended March 31, 2026, compared to $16.6 million for the same period in 2025.

Subsequent to quarter-end, the Company has raised $22.6 million proceeds using its at-the-market (ATM) facility.

The Company believes that its cash resources as of March 31, 2026, together with the net proceeds that it raised from equity offerings in the second quarter of 2026, will fund its planned operating and capital expenditure requirements into early second quarter of 2027.

As of May 8, 2026, the Company had 15,940,601 shares of common stock outstanding.

First Quarter 2026 Financial Results

Net product revenue for the first quarter 2026 was approximately $6.9 million, compared to $2.4 million for the same period in 2025, and consisted of combined net sales of TONMYA, Zembrace^® SymTouch^®, and Tosymra^®. Net revenue from sales of TONMYA for the first quarter was approximately $3.7 million. TONMYA was launched in November 2025. Net revenue from sales of TONMYA for the period from November 17, 2025, to December 31, 2025, was approximately $1.4 million. Net revenue from sales of Zembrace^® SymTouch^® and Tosymra^® for the was approximately $3.2 million compared to $2.4 million for the same quarter in 2025. Cost of sales for the first quarter 2026 was approximately $1.6 million, compared to $0.9 million for the same period in 2025.

Research and development expenses for the first quarter 2026 were approximately $18.2 million, compared to $7.4 million for the same period in 2025. This increase is predominately due to pipeline prioritization period over period, and increased headcount.

Selling, general, and administrative expenses for the first quarter 2026 were $28.6 million, compared to $10.1 million for the same period in 2025. The increase is predominately due to spending on sales and marketing related to TONMYA, as well as increased headcount.

Net loss available to common stockholders was $40.2 million, or $2.93 per basic and diluted share, for the first quarter 2026, compared to net loss available to common stockholders of $16.8 million, or $2.84 per basic and diluted share, for the same period in 2025. The basic and diluted weighted average common shares outstanding for the first quarter 2026 was 13,707,104 compared to 5,927,231 shares for the same period in 2025.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA^® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s recently approved flagship medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace^® SymTouch^® and Tosymra^®. Tonix is maximizing the science behind TONMYA in Phase 2 clinical studies to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 for Lyme disease prevention in the U.S. and TNX-801, a vaccine in development for the prevention of mpox and smallpox. Within immunology, Tonix is developing TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome. To learn more, visit www.tonixpharma.com.

*Tonix’s product development candidates 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.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals
(862) 799-8599
[email protected]

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

Media Contacts
Deborah Elson
Tonix Pharmaceuticals
[email protected]

Ray Jordan
Putnam Insights
[email protected]

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Release – GeoVax Initiates Phase 3 Execution Activities for GEO-MVA Under EMA-Aligned Immunobridging Pathway

Posted on May 6, 2026May 6, 2026 by [email protected]

Research News and Market Data on GOVX

Company Advances to Active Clinical Execution, Supporting Potential Accelerated Path Toward Regulatory Authorization

ATLANTA, GA – May 6, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies, today announced that it has initiated operational execution activities in support of its planned Phase 3 immunobridging clinical study for GEO-MVA, its Modified Vaccinia Ankara (MVA) vaccine candidate targeting mpox and smallpox.

This milestone marks GeoVax’s transition from strategic program positioning to active clinical-stage execution, following prior regulatory alignment with the European Medicines Agency (EMA) supporting an expedited development pathway.

Execution Activities Now Underway

GeoVax confirmed that multiple core execution workstreams are underway:

Clinical Operations: A global contract research organization (CRO) has been selected
Trial Infrastructure Activation: Clinical site identification and activation planning progressing in alignment with study requirements
Manufacturing Readiness: Clinical trial material manufactured and fill/finish product has been completed and released for clinical use
Regulatory Execution Alignment: Ongoing implementation of EMA-guided immunobridging strategy designed to support an efficient path to authorization

The planned Phase 3 immunobridging arm of the clinical trial is expected to enroll approximately 500 participants and evaluate neutralizing antibody responses relative to the approved MVA-based comparator vaccine. This study design intentionally provides rapid clinical validation, further de-risking the program in addition to the expedited development pathway.

From Defined Pathway to Active Execution

“We are now executing against a clearly defined clinical and regulatory pathway for GEO-MVA,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “Our focus has shifted decisively to operational execution of the Phase 3 program. The EMA’s guidance provides a structured and efficient pathway centered on immunobridging, and we are advancing accordingly.”

Dodd added, “Our objective is to move efficiently through study initiation and execution, positioning GEO-MVA to support global preparedness needs while advancing toward potential regulatory authorization. Our study plan is structured to provide the immunobridging study results within 8-12 weeks following trial initiation.”

Positioned for Efficient Clinical Advancement

The EMA-supported immunobridging approach is designed to:

Leverage established MVA platform experience
Focus on quantitative neutralizing antibody endpoints
Enable a streamlined development pathway relative to traditional efficacy trials

GeoVax believes this approach supports a clear and actionable pathway from development toward potential commercialization.

Addressing a Critical Global Need

GEO-MVA is being advanced as a potential second-source MVA-based vaccine, addressing ongoing global demand for orthopoxvirus vaccines and reducing reliance on a single supplier.

Public health agencies and governments continue to emphasize the importance of resilient and diversified vaccine supply, particularly in the context of evolving mpox dynamics and preparedness requirements.

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.

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected]

Release – Cocrystal Pharma Presentation at ICAR 2026 Highlights Mechanism of Action and Clinical Advancement of CDI-988 for the Prevention and Treatment of Norovirus Infection

Posted on April 30, 2026May 1, 2026 by [email protected]

Research News and Market Data on COCP

April 30, 2026

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Ongoing Phase 1b human challenge study with oral, direct-acting protease inhibitor is designed to demonstrate proof-of-concept as a preventive and a treatment
Fully enrolled first cohort is assessing the infectivity of the human challenge inoculum
There are no approved treatments or vaccines for norovirus, the leading cause of acute gastroenteritis across all age groups and geographies with a $60 billion annual economic burden
FDA Fast Track designation granted for CDI-988 underscores the lack of approved therapies and seriousness of norovirus infection

BOTHELL, Wash., April 30, 2026 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that the mechanism of action and clinical advancement of its first oral protease inhibitor CDI-988 were featured today in an oral presentation at the 39^th International Conference on Antiviral Research (ICAR 2026) in Prague, Czech Republic. The presentation, titled “First Oral Direct-Acting Antiviral CDI-988 for Norovirus Infection Prevention and Treatment: Novel Mechanism of Action and Phase 1 Study Results,” was delivered by Sam Lee, Ph.D., President and co-CEO of Cocrystal. Presentation slides are available on the Company’s website here.

“It was an honor to share our progress with CDI-988 with the global antiviral research community attending ICAR 2026,” said Dr. Lee. “Following favorable Phase 1 data, we have advanced CDI-988 into a Phase 1b study under a human challenge model that provides an efficient framework to rapidly demonstrate proof of concept as a preventive and as a treatment for norovirus infection. We have now completed enrollment of the stage 1 study cohort, which will establish the infectivity rate of the GII.2 (Snow Mountain Virus) challenge inoculum. This is a critical step in validating infectivity in the study cohorts.

“Multiple norovirus vaccine clinical studies have been initiated over the past decade, yet none have led to an approval in part due to the virus’s extensive genetic variation and drift, spanning 10 genogroups and 49 genotypes,” Dr. Lee added. “CDI-988 is designed to target the highly conserved region of the 3CL protease across all known norovirus strains, including GII.4 and the re-emerging GII.17 variants, as well as all coronaviruses. We believe this compound could offer a much‑needed option for prevention and treatment in a convenient oral formulation that can be readily stockpiled in advance of norovirus outbreaks.”

CDI-988 is a first, oral direct-acting antiviral and was developed using Cocrystal’s proprietary structure-based drug discovery platform technology. As presented by Dr. Lee, in preclinical studies CDI-988 showed favorable gastrointestinal-targeted pharmacokinetics at the site of norovirus infection and also demonstrated potent antiviral activity in GII.4-infected human enteronoid model systems.

In a completed randomized, double‑blind, placebo‑controlled single‑ and multiple‑ascending dose Phase 1 study in healthy adults, CDI‑988 was generally safe and well tolerated across doses up to 1,200 mg, with headache as the most common treatment‑emergent adverse event and no serious adverse events reported. These results, together with a no-observed adverse effect of 1,000 mg/kg in GLP toxicology studies, support CDI-988’s further clinical development in norovirus.

The ongoing Phase 1b randomized, double‑blind, placebo‑controlled challenge study (NCT07198139) is being conducted at Emory University School of Medicine in collaboration with the University of North Carolina. The study is designed to enroll up to 40 healthy adults, ages 18 to 49, in staged cohorts. The stage 1 infectivity cohort, now fully enrolled, will be followed by prevention and treatment cohorts in which CDI‑988 is administered at 1,200 mg twice daily for five days. The primary efficacy endpoint is reduction in the incidence of clinical symptoms, with secondary endpoints including reduction in viral shedding, disease severity, safety and pharmacokinetics.

CDI‑988 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment and prophylaxis of norovirus infection, underscoring the serious nature of norovirus disease and the lack of approved therapies. Fast Track status is intended to facilitate development and expedite the review of drugs that address unmet medical needs, providing opportunities for more frequent FDA interactions, rolling review of a potential New Drug Application and potential eligibility for Priority Review.

About Norovirus

Norovirus is the leading cause of acute gastroenteritis among all age groups and all geographic regions. It is highly contagious and causes symptoms including nausea, vomiting, stomach pain, diarrhea, fatigue, fever and dehydration. It is notorious for outbreaks in semi-closed environments such as hospitals, nursing homes, cruise ships, schools and military facilities. Norovirus is responsible for an estimated 685 million cases and an estimated 200,000 deaths globally each year, with an approximate $60 billion in worldwide economic impact. In the United States alone, the virus is associated with 21 million infections annually, resulting in around 109,000 hospitalizations, 465,000 emergency department visits and 900 deaths. The estimated annual economic burden in the U.S. exceeds $10.6 billion. In developing nations, norovirus contributes up to 1.1 million hospitalizations and 218,000 pediatric deaths each year.

About ICAR

Hosted by the International Society for Antiviral Research (ISAR), the International Conference on Antiviral Research (ICAR) brings together leading scientists, researchers and industry professionals from around the world to discuss the latest advancements and breakthroughs in antiviral research. ICAR provides a variety of networking opportunities allowing members to connect with colleagues and establish new scientific relationships and collaborations with leaders in the antiviral field.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2), and rhinoviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create viable antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding any implications that CDI-988 is able to prevent and/or treat norovirus infections. The words “believe,” “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. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations, the progress and results of the studies including any adverse findings or delays, the ability of us and our CROs to recruit volunteers for, and to otherwise proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes and any adverse developments which may arise therefrom, and general economic adverse effects from the ongoing conflict with Iran. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025. 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.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
[email protected]

# # #

Source: Cocrystal Pharma, Inc.

Released April 30, 2026

Release – GeoVax Advances Gedeptin® Toward Phase 2 Initiation and Strategic Partnership Opportunities

Posted on April 29, 2026April 29, 2026 by [email protected]

Research News and Market Data on GOVX

Near-Term Clinical Milestones and Combination Strategy Position Program for Next Stage of Value Creation

ATLANTA, GA – April 29, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today outlined near-term development milestones and strategic priorities for its oncology program, Gedeptin^®, as the Company advances toward Phase 2 clinical initiation and potential partnership opportunities.

With oncology treatment increasingly defined by combination regimens, the ability to integrate into established therapeutic backbones is becoming a key factor in clinical and commercial success. GeoVax believes the convergence of upcoming clinical milestones and increasing industry focus on combination approaches creates a timely opportunity to advance Gedeptin’s development and strategic positioning.

Advancing Toward Phase 2 Clinical Execution

GeoVax is advancing Gedeptin with a focus on integration into combination treatment regimens, particularly alongside immune checkpoint inhibitors (ICIs) and other established oncology backbones. The Company believes this approach aligns with the evolving treatment landscape and may support broader applicability across multiple tumor types. GeoVax is preparing to initiate a Phase 2 clinical trial evaluating Gedeptin, in combination with an ICI, as a first-line neoadjuvant treatment in patients with resectable locally advanced head and neck cancer, with trial initiation targeted for 2027.

The study is designed to evaluate:

Tumor response in the neoadjuvant setting
Biomarker-driven immune activation
Event-free survival outcomes

This trial is expected to represent a key step in establishing clinical validation for Gedeptin in combination immuno-oncology strategies.

Expanding Development Across Additional Solid Tumors

In parallel with its lead clinical program, GeoVax is planning to advance preclinical and translational work evaluating Gedeptin across additional solid tumor indications. These efforts are intended to (a) identify tumor settings where combination approaches may provide the greatest clinical benefit, (b) support expansion beyond head and neck cancer and, (c) inform future clinical development strategies.

Positioned for Strategic Collaboration

GeoVax is actively pursuing opportunities to advance Gedeptin through clinical development partnerships, combination-focused collaborations and potential licensing or co-development arrangements.

“We are entering an important phase of development for Gedeptin, with a focus on clinical execution and advancing discussions around potential partnerships,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “As combination therapy becomes more common across oncology, we believe Gedeptin is well positioned to be integrated into these regimens and contribute to improved treatment outcomes.”

Supported by an Established Clinical and Scientific Foundation

GeoVax has established a clinical and scientific foundation to support Gedeptin’s advancement into its next stage of development, including:

Completed Phase 1/2 clinical experience in advanced head and neck cancer
Engagement of an Oncology Advisory Board with deep immuno-oncology expertise
Expanded intellectual property supporting combination use with checkpoint inhibitors

This foundation is intended to support both continued clinical progression and engagement with potential partners.

About Gedeptin^®

Gedeptin^® is a gene-directed enzyme prodrug therapy (GDEPT) delivered intratumorally using a non-replicating viral vector encoding purine nucleoside phosphorylase (PNP). Following administration of a systemically delivered prodrug, the encoded enzyme converts the prodrug into a cytotoxic agent directly within the tumor microenvironment.

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

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected]

Release – Ocugen to Host Conference Call on Tuesday, May 5 at 8:30 A.M. ET to Discuss Business Updates and First Quarter 2026 Financial Results

Posted on April 29, 2026April 29, 2026 by [email protected]

Research News and Market Data on OCGN

April 29, 2026

PDF Version

MALVERN, Pa., April 29, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it will host a conference call and live webcast to discuss the Company’s first quarter 2026 financial results and provide a business update at 8:30 a.m. ET on Tuesday, May 5, 2026.

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

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 4973685
Webcast: Available on the events section of the Ocugen investor site

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

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

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
[email protected]

Release – Tonix Pharmaceuticals Announces Presentation of Phase 1 Data and Plans for an Adaptive Phase 2 Field Study of TNX-4800 (anti-Borrelia OspA monoclonal antibody) for the Prevention of Lyme Disease at the 4th Annual Ticks and Tickborne Diseases Symposium at Johns Hopkins University

Posted on April 29, 2026April 29, 2026 by [email protected]

Research News and Market Data on TNXP

April 29, 2026 7:00am EDT Download as PDF

Company on track to initiate a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study in the first half of 2027, pending FDA agreement

Phase 2 field study expected to test a two-dose regimen of TNX-4800 subcutaneous with an initial Spring dose followed by a Summer booster two months later; the primary endpoint is Lyme disease prevention for six months

TNX-4800 is expected to provide protection against Lyme disease within two days of the first dose for the peak of the U.S. Lyme season

BERKELEY HEIGHTS, N.J., April 29, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced presentation of Phase 1 data and plans for an adaptive Phase 2 field study of TNX-4800 (formerly known as mAb 2217LS)^1,2 for the prevention of Lyme disease in the U.S., at the 4^th Annual Ticks and Tickborne Diseases Symposium. The Phase 2 study is expected to initiate in the first half of 2027, pending FDA agreement.

The Phase 1 study was conducted by a team at UMass Chan Medical School led by Mark S. Klempner, MD, Professor of Medicine at UMass Chan and an inventor of TNX-4800. The adaptive Phase 2 field study is being planned by Tonix, which licensed TNX-4800 from UMass Chan Medical School in 2025.

TNX-4800 is a long-acting bactericidal (or borreliacidal), human monoclonal antibody (mAb) that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the spirochete bacteria that causes 99.9% of Lyme disease cases in the U.S.^3,4 TNX-4800 was engineered to include a crystallizable fragment (Fc) domain that provides an extended half-life. Tonix is developing TNX-4800 for the prevention of Lyme disease during the U.S. tick season. There are currently no marketed U.S. Food and Drug Administration (FDA)-approved vaccines or prophylactics to protect against Lyme disease.

“We plan to initiate an adaptive Phase 2 field study in the first half of 2027 pending FDA agreement,” said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals. “We intend to test a two-dose regimen of TNX-4800, with the first dose administered in the Spring and a second dose administered two months later, for protection against Lyme disease for six months following the initial dose as the primary endpoint. We believe the Phase 1 pharmacokinetic (PK) data support this study design. Each fixed subcutaneous (SC) dose is expected to provide exposures comparable to the 5 mg/kg SC dose evaluated in Phase 1. We have scheduled a meeting with the FDA early in the third quarter of 2026. We look forward to advancing the clinical investigation of TNX-4800 as we strive to overcome the major public health challenges posed by Lyme disease.”

Dr. Lederman continued, “As a long-acting monoclonal antibody that offers passive immunity against the Lyme-causing bacteria within two days, we believe TNX-4800 offers significant advantages over the alum-based combination multi-OspA subunit vaccine in late-stage clinical development. Lyme disease vaccines that elicit antibodies to OspA take more than six months to offer protection and require complex immunization schedules which are obstacles to adherence. A previously approved alum-based OspA subunit vaccine was withdrawn due to poor uptake,⁶ potentially relating to its complex immunization schedule. We believe TNX-4800’s differentiating characteristics could offer meaningful improvements for people seeking protection from Lyme disease.”

A copy of the poster is available under the Scientific Presentations tab on the Tonix website at www.tonixpharma.com.

Adaptive Phase 2 Field Study Plans
Pending FDA agreement, the Company plans to initiate an adaptive field study in the first half of 2027. The Company plans to study TNX-4800 in a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study to evaluate the efficacy of a two-dose regimen of TNX-4800 SC, in preventing the first occurrence of confirmed Lyme disease during the primary efficacy surveillance period (Day 3 through Month 6 following administration). The two-dose regimen of TNX-4800 was selected for the Phase 2 field study based on the pharmacokinetic results of the Phase 1 study. Each fixed dose is expected to provide exposures comparable to the 5 mg/kg dose evaluated in Phase 1. The first dose will be administered in the Spring and the second booster dose will be administered two months later. Participants will include adolescents and adults 16 years of age and older in Lyme-endemic areas in the U.S. The primary endpoint will be the prevention of Lyme disease for six months (comparison of TNX-4800 group and placebo group) following the initial dose. The Company has scheduled a Type C meeting with the FDA early in the third quarter of 2026 to discuss the planned adaptive Phase 2 field study design.

The Company expects to have Good Manufacturing Practice (GMP) investigational product available for clinical testing in early 2027.

About TNX-4800
TNX-4800 (formerly known as mAb 2217LS) is a long-acting bactericidal, 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 either kills or 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 serum levels of at least 21 μg/ml, were approximately 95% effective at preventing infection of non-human primates after six days of exposure to ticks infected with Borrelia burgdorferi.¹^,2 TNX-4800 was derived from mAb 2217 by amino acid substitutions in its Fc domain, which serve to prolong the serum half-life. As a monoclonal antibody, TNX-4800 is designed to provide passive immunity against Lyme disease within two days without relying on the recipient’s immune system to generate antibodies. TNX-4800 also avoids the complex immunization schedules required for an alum-based combination multi-OspA subunit vaccine in development⁷ and the FDA-approved alum-based OspA subunit vaccine that was withdrawn from the market.⁸ TNX-4800 is protected by Issued US Patent US 10,457,721, which is licensed from UMass Chan with expiry in January 2036, excluding any possible Patent Term Extension based on the duration of the clinical trials and the FDA approval process.

TNX-4800 Phase 1 Study Results
TNX-4800 was studied in a randomized, double-blind, sequential dose-escalation study (NCT04863287) that evaluated safety, tolerability, PK, and immunogenicity of TNX-4800 in healthy adults. 44 subjects were randomized, and 41 completed the study. Subjects received a single SC dose of placebo or TNX-4800 at 0.5, 1.5, 5, or 10 mg/kg. Safety was assessed via clinical and lab evaluations. Results showed no significant clinical or laboratory safety signals. All drug-related adverse events were mild or moderate, except for a single severe adverse event that was deemed not drug-related. 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 two days, indicating rapid systemic absorption. TNX-4800 concentrations remained quantifiable up to 12 months in the majority of participants. At the highest dose of TNX-4800 tested in rats with 1.5-fold higher exposure compared to 10 mg/kg cohort, no adverse toxicity was observed, thus the highest dose tested was considered No Observed Adverse Effect Level (NOAEL). Confirmed anti-drug antibodies (ADSs) were observed transiently in <10% of treated participants, with no impact on PK. TNX-4800 was determined to be generally safe and well tolerated.

About Lyme Disease
In the U.S., Lyme disease is caused by the spirochete bacteria Borrelia burgdorferi. Lyme disease remains the most common vector-borne infection in the United States, and its incidence is climbing each year, due to the expanding the habitat range for ticks.⁸Approximately 87 million people in the United States live, work, or vacation in a tick-endemic area placing them at risk of contracting the disease.⁹ 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.¹⁰

Citations
¹Schiller ZA, et al. J Clin Invest. 2021 131(11):e144843.
²Wang Y, et al. J Infect Dis. 2016. 214(2):205-11.
³Marques AR, et al. Emerg Infect Dis. 2021. 27(8):2017-2024.
⁴Pritt BS, et al. Lancet Infect Dis. 2016. 6(5):556-564.
⁵Nigrovic LE, et al. Epidemiol Infect. 2006. Aug 8;135(1):1-8.
⁶Comstedt P, et al. Vaccine. 2015 33(44):5982-8.
⁷Connaught’s (ImuLyme™) and SmithKline Beecham’s (LYMErix™) Lyme disease vaccines were withdrawn. Nigrovic LE, et al. Epidemiol Infect. 2007 135(1):1-8.
⁸Gomes-Solecki M, et. al. Clin Infect Dis. 2020 70(8):1768-1773.
⁹Kugeler KJ, et al. Emerg Infect Dis. 2021. 27(2):616-619.
¹⁰National 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. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD154/CD40 ligand (CD40L) inhibitor for the prevention of kidney transplant rejection. In addition, Tonix is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. To learn more, visit www.tonixpharma.com.

*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. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA^® and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals
[email protected]
(862) 799-8599

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

Media Contacts
Deborah Elson
Tonix Pharmaceuticals
[email protected]

Ray Jordan
Putnam Insights
[email protected]

Source: Tonix Pharmaceuticals Holding Corp.

Released April 29, 2026

Release – Cardiff Oncology Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Posted on April 28, 2026April 30, 2026 by [email protected]

Research News and Market Data on CRDF

April 28, 2026

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SAN DIEGO, Calif., April 28, 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, announced that in connection with Dr. Aggarwal joining Cardiff Oncology as Chief Operating Officer, the Company’s Compensation Committee approved the grant of non-qualified stock options to purchase 400,000 shares of Cardiff Oncology common stock outside of the Cardiff Oncology 2021 Omnibus Equity Incentive Plan. The stock option was granted as an inducement material to Dr. Aggarwal becoming an employee of Cardiff Oncology in accordance with Nasdaq Listing Rule 5635(c)(4). The option was granted as of April 27, 2026, and has an exercise price of $1.72 per share, the closing price on the grant date. The option vests over four years with 25% vesting after 12 months and the remaining shares vesting monthly over the following 36 months, subject to Dr. Aggarwal’s continued employment with Cardiff Oncology on such vesting dates.

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

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

Investor Contact:
Candice Masse
astr partners
[email protected]

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

Release – NeuroSense Announces Pricing of Insider-Led PIPE Financing

Posted on April 28, 2026April 30, 2026 by [email protected]

Research News and Market Data on NRSN

Financing led by CEO Alon Ben-Noon and CFO Or Eisenberg, alongside participation from an existing significant shareholder

CAMBRIDGE, Mass., April 28, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced the entry into a definitive agreement with certain investors to purchase $600,000 of ordinary shares in a private placement. In connection with the offering, NeuroSense agreed to sell an aggregate of 750,000 ordinary shares at a price of $0.80 per share, representing a purchase price of 6.7% above the closing pricing of NeuroSense’s ordinary shares on April 27, 2026.

The private placement is subject to customary closing conditions and is expected to close during the week of May 3, 2026.

The private placement included participation from Company insiders and a leading existing shareholder. Chief Executive Officer Alon Ben-Noon, Chief Financial Officer Or Eisenberg, and a significant existing investor each committed $200,000 in the offering.

The Company intends to use the proceeds for general corporate purposes ahead of upcoming clinical and regulatory milestones.

The offering is being made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act and/or Regulation D thereunder. Accordingly, the securities issued in the offering may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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

About 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.

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, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding the offering, including as to the consummation of the offering described above, the expected gross proceeds from the offering, the intended use of proceeds and the timing of the receipt of proceeds of the offering, 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 outcomes and the timing of current and future clinical trials; 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.

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

SOURCE NeuroSense

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

Release – GeoVax Highlights Gedeptin® as a Potential Immune-Sensitizing Platform Amid Rising Industry Investment in In Vivo Cancer Therapies

Posted on April 27, 2026April 27, 2026 by [email protected]

Research News and Market Data on GOVX

Positioned to Enhance Efficacy of Checkpoint Inhibitors and Next-Generation Oncology Modalities Across Solid Tumors

ATLANTA, GA – April 27, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today highlighted the strategic positioning of its oncology asset, Gedeptin® (Ad/PNP), in the context of accelerating industry investment in next-generation in vivo cancer therapies.

Recent high-profile transactions and investments across the biopharmaceutical sector underscore a growing focus on therapies designed to simplify delivery, improve scalability, and expanding therapeutic reach. As these approaches advance, a central challenge remains: many tumors are immunologically “cold,” limiting the effectiveness of even the most advanced therapeutic modalities. GeoVax believes Gedeptin is uniquely positioned to address this challenge.

“While the industry is investing heavily in next-generation cell and gene therapies, the ability to positively modify the local tumor environment is believed to be one of the critical determinants of clinical success,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “Gedeptin is designed to directly destroy both proliferating and non-proliferating tumors, while also demonstrating high bystander activity due to the ability of the in situ generated cytotoxic agent ability to diffuse into neighboring tumor cells.”

Gedeptin is a gene-directed enzyme prodrug therapy (GDEPT), delivered intratumorally, designed to generate PNP, selectively destroy both proliferating and non-proliferating tumor cells within the treated tumor. In vivo preclinical experiments have shown PNP treatment to be additive or synergistic with checkpoint blockade–type agents. For example, studies in preclinical in vivo tumor models of metastasis, have demonstrated treatment of a single lesion can robustly sensitize tumors to checkpoint blockade inhibitors, presumably by destroying tumor tissue (including the tumor microenvironment), exposing neoantigens, and enhancing immune response and activity of immune check point inhibitors (ICIs) at distant PNP-untreated lesions This dual mechanism – localized cytotoxicity combined with enhancing the immune response and activity of immune check point inhibitors against both Gedeptin treated and untreated tumors – has the potential to offer an improved therapeutic approach to addressing solid tumor metastatic disease.

GeoVax has generated preclinical, clinical and translational data supporting Gedeptin’s ability to:

Induce localized tumor cell death against both proliferating and non-proliferating tumors, while minimizing systemic toxicity
Potentially improve response rates when combined with immune checkpoint inhibitors

Aligned with the Next Phase of Immuno-Oncology Innovation

As checkpoint inhibitors continue to move earlier in treatment paradigms, including neoadjuvant and first-line settings, the need for complementary approaches that enhance response rates is becoming increasingly evident.

GeoVax is advancing Gedeptin in combination with checkpoint inhibition in a planned Phase 2 clinical trial in first-line head and neck cancer therapy, with additional solid tumor indications under evaluation.

“Checkpoint inhibitors have transformed cancer care, but many patients still do not achieve durable responses,” said Kelly T. McKee, M.D., Chief Medical Officer of GeoVax. “We believe Gedeptin is well positioned as a combination-enabling platform designed to enhance therapeutic response across checkpoint inhibitors and other emerging oncology modalities.”

About Gedeptin®

Gedeptin® is a gene-directed enzyme prodrug therapy (GDEPT) delivered intratumorally using a non-replicating viral vector encoding purine nucleoside phosphorylase (PNP). Following administration of a systemically delivered prodrug, the encoded enzyme converts the prodrug into a cytotoxic agent directly within the tumor microenvironment. This localized approach is designed to selectively destroy tumor cells while promoting immune recognition and minimizing systemic toxicity. Gedeptin has received Orphan Drug Designation for oral and pharyngeal cancers.

The Company continues to evaluate strategic partnerships and collaborations to advance the clinical development and potential commercialization of Gedeptin-based combination therapies.

About GeoVax

Forward-Looking Statements

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected]

Release – Cardiff Oncology to Host Key Opinion Leader Discussion on Onvansertib’s Promising Single-Agent Activity

Posted on April 27, 2026April 27, 2026 by [email protected]

Research News and Market Data on CRDF

April 27, 2026

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SAN DIEGO, April 27, 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 data from an investigator-initiated trial on onvansertib’s single-agent clinical activity in chronic myelomonocytic leukemia (CMML). The webinar will take place on Thursday, April 30th, 2026, at 11:00 a.m. ET.

The webinar will feature KOL Mrinal Patnaik, MBBS, a physician scientist with the Division of Hematology, Department of Internal Medicine at Mayo Clinic, Minnesota. He is the Chair of the Acute Leukemia and Myeloid Neoplasms group at Mayo Clinic, Rochester and is also the Scientific Director of the Epigenetics Developmental Laboratory and the Epigenomics Program. His main clinical and research interests lie in precision genomics and epigenetics and the application of the same to myeloid neoplasms and bone marrow failure syndromes. He directs the Mayo Clinic Clonal hematopoiesis Clinic (CHIP), bone marrow failure syndrome clinic and the short telomere clinic.

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.

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

Investor Contact:
Candice Masse
Astr Partners
[email protected]

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

Release – Tonix Pharmaceuticals Presents Updates on Preclinical Immuno-Oncology Programs at the American Association for Cancer Research (AACR) Annual Meeting 2026

Posted on April 23, 2026April 23, 2026 by [email protected]

Research News and Market Data on TNXP

April 23, 2026 7:00am EDTDownload as PDF

TNX-1700 (TFF2-albumin fusion protein) reversed aging-associated gastric inflammation and significantly attenuated tumor progression in aged gastric microenvironment in preclinical models

TNX-1700 exhibited dose-independent, linear pharmacokinetics in animals

TNX-4700 (human anti-BTLA monoclonal antibody) demonstrated potent, high-affinity binding and functional antagonism

BERKELEY HEIGHTS, N.J., April 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 and two poster presentations on its preclinical immuno-oncology portfolio at the American Association for Cancer Research (AACR) Annual Meeting 2026, held April 17-22, 2026, in San Diego, California.

“We are pleased to report encouraging preclinical data on our TFF2-albumin fusion protein (TNX-1700) and our anti-BTLA monoclonal antibody (mAb) (TNX-4700) at AACR,” said Bruce Daugherty, PhD, MBA, Executive Vice President of Research at Tonix Pharmaceuticals. “TNX-1700 and TNX-4700 are investigational immuno-oncology candidates in pre-clinical development. TNX-1700 is in development for the treatment of gastric and colorectal cancer in combination with PD-1 inhibitors. TNX-4700 is in development for the treatment of potentially several cancers since its ligand HVEM is expressed and/or upregulated in the tumor microenvironment and generally correlates with reduced overall survival.”

Abstract #: 6822 Oral Presentation: “TFF2 Deficiency Amplifies IL-1β–Driven Inflammation and Promotes Aging-Associated Gastric Tumor Progression”

Presenting author: Shuang Li, MD, PhD, Postdoctoral Research Scientist in the Timothy C. Wang, MD, Laboratory at the Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center

Aging is a major risk factor for gastric cancer, but the underlying mechanisms remain poorly defined. The stomach undergoes profound epithelial and immune remodeling during aging. TFF2 is a mucosal protective factor implicated in epithelial repair and immune regulation. However, whether TFF2 regulates age-associated inflammation and tumor progression remains unknown.

TFF2-expressing epithelial cells were reduced in the stomachs of aged mice compared to young mice, with corresponding reductions in tissue and circulating TFF2 levels. Decline of TFF2 led to elevated IL-1β and promoted gastric inflammaging. The murine version of TNX-1700 (mTNX-1700 or TFF2-MSA) treatment reversed aging-associated inflammation. The aged stomach exhibited increased susceptibility to tumor progression. Myeloid-derived stem cells (MDSCs) accumulated and overexpressed IL-1β, interacting with IL-1R1⁺ cancer associated fibroblasts (CAFs). mTNX-1700 attenuated tumor progression in the aged gastric microenvironment.

Poster Presentation #7940: “Pharmacokinetics of TNX-1700 in Non-Human Primates and Human FcRn/Serum Albumin Transgenic Mice”

Presenting author: Bruce Daugherty, PhD, MBA, Executive Vice President of Research, Tonix

TNX-1700 was evaluated in double-transgenic mice expressing human FcRn and human serum albumin (HSA) and in non-human primates. All animals survived without clinical signs or greater than 10% body-weight loss. TNX-1700 exhibited dose-independent, linear pharmacokinetics, with comparable pharmacokinetic profiles and exposure observed across species and doses. TNX-1700 substantially extends the half-life of TFF2 and achieves durable systemic exposure, supporting its potential as a therapeutic candidate for gastric cancer.

Poster Presentation #6550: In Vitro Characterization of Fully Human Antagonistic Anti-BTLA Monoclonal Antibodies

Presenting author: Bruce Daugherty, PhD, MBA, Executive Vice President of Research, Tonix

B and T Lymphocyte Attenuator (BTLA) is a promising target in immuno-oncology since its ligand HVEM (herpesvirus entry mediator) is expressed in and upregulated in the tumor microenvironment of many cancers and generally correlates with reduced overall survival. Targeting BTLA offers opportunities for cancer immunotherapy and may demonstrate additive or synergistic activity when combined with other checkpoint antagonists, potentially overcoming resistance mechanisms and improving clinical outcomes.

Tonix studied several anti-BTLA mAbs, which demonstrated potent, high-affinity binding and functional antagonism of BTLA in vitro. Antagonists with reduced FcgRI binding and no binding to FcgRIIB may improve pharmacokinetics and confer a reduced risk of FcR-dependent adverse events, such as cytokine release syndrome or other immune-mediated toxicities.

Copies of the two poster presentations are available under the Scientific Presentations tab on the Tonix website at www.tonixpharma.com.

About Trefoil Factor Family Member 2 (TFF2)
Human TFF2 is a secreted protein expressed in gastrointestinal mucosa where it functions to protect and repair the mucosal lining. In gastric cancer, TFF2 is epigenetically silenced, and TFF2 is suggested to be protective against cancer development through several mechanisms, including its activity as a partial agonist of CXCR4 that modulates myeloid cell trafficking to reduce accumulation of immunosuppressive neutrophils.

About TNX-1700
TNX-1700, a fusion protein of TFF2 and albumin, is in preclinical and pre-Investigational New Drug (IND) stage of development as a treatment of gastric and colorectal cancer in combination with PD-1 blockade.¹ The Company in-licensed TFF2 technology from Columbia University. TNX-1700 is an immunotherapy being developed to treat gastric and colorectal cancers in combination with PD-1 blockers. Results of preclinical testing demonstrated that a mouse version of TNX-1700 was able to evoke an increase in anti-tumor immunity in combination with anti-PD-1 in several mouse models of gastric cancer by reducing immunosuppressive neutrophils and activating anti-tumoral CD8+ T cell responses. TNX-1700 administered as both monotherapy and in combination with anti-PD-1 dramatically reduced metastasis and increased survival in these models; these findings were recently published.¹ TNX-1700 addresses a central mechanism of therapeutic resistance to anti-PD-1 therapy in gastric cancer by targeting the CXCR4-driven myeloid axis to normalize cancer-induced myelopoiesis and reprogram the tumor microenvironment.

About BTLA
BTLA (B and T lymphocyte attenuator) is a protein on the surface of tumor infiltrating lymphocytes. Targeting BTLA is a promising target in immuno-oncology since its ligand HVEM is expressed and/or upregulated in the tumor microenvironment of many cancers including melanoma, non-small cell lung cancer, colorectal cancer, gastric cancer, glioblastoma, and prostate cancer and generally correlates with reduced overall survival. Targeting BTLA offers opportunities for cancer immunotherapy and may demonstrate additive or synergistic effects when combined with other checkpoint antagonists, potentially overcoming resistance mechanisms and improving clinical outcomes.

About TNX-4700
Tonix is developing TNX-4700 (anti-BTLA) mAb for immuno-oncology indications. The mAb technology was licensed from Curia.

Citations:

Qian J, et al. Cancer Cell. 2025. 43(8):1512-1529.e11.

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. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. In addition, the Company is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. 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. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA® and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. 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.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals
[email protected]
(862) 799-8599

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

Media Contacts
Deborah Elson
Tonix Pharmaceuticals
[email protected]

Ray Jordan
Putnam Insights
[email protected]

Source: Tonix Pharmaceuticals Holding Corp.

Released April 23, 2026