Zelluna Reaches Major Milestone and Submits Clinical Trial Application in the UK for First-in-Human Study of ZI-MA4-1 (ZIMA-101), the World’s First MAGE-A4-Targeting TCR-NK Cell Therapy for Solid Tumours




Zelluna Reaches Major Milestone and Submits Clinical Trial Application in the UK for First-in-Human Study of ZI-MA4-1 (ZIMA-101), the World’s First MAGE-A4-Targeting TCR-NK Cell Therapy for Solid Tumours

• On track for initial clinical data in mid-2026
• Marks a pivotal step toward scalable, accessible, off-the-shelf cell therapies for solid tumours

Oslo, Norway, 17 December 2025 – Zelluna (OSE: ZLNA), a company pioneering allogeneic off-the-shelf cell therapies for cancer, today announced the submission of its Clinical Trial Application (CTA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for ZI-MA4-1, the Company’s lead candidate.

The CTA submission marks Zelluna’s transition from preclinical to clinical development and represents the successful delivery of all key milestones communicated for 2025:

• Manufacturing process locked (April 2025)
• Preclinical data package completed and key data published (December 2025)
• GMP clinical batch produced and quality-tested (December 2025)
• Clinical Trial Application submitted to the UK MHRA (December 2025)

ZI-MA4-1 is a novel cell therapy that combines two powerful cancer fighting mechanisms: precise solid tumour targeting of T cell receptors (TCRs) with the potent and broad cancer killing ability of Natural Killer (NK) cells. ZI-MA4-1 targets MAGE-A4, a protein found in many solid cancers including lung, ovarian, head and neck and sarcomas.  

“Submitting our first CTA is a transformational moment for Zelluna,” said Namir Hassan, Chief Executive Officer of Zelluna. “ZI-MA4-1 will be the first MAGE-A4-targeting TCR-NK cell therapy to enter clinical testing globally and represents the culmination of rigorous scientific, non-clinical, CMC and regulatory work. Reaching this major milestone is a testament to the unwavering dedication and talent of the Zelluna team past and present, the guidance of our board, and the commitment of our investors. I am immensely proud of our team for delivering on the commitments we set out to achieve this year. We now enter the most important phase of our journey – demonstrating the potential of TCR-NK therapies for solid cancer patients.”

Zelluna’s CTA submission comes as off-the-shelf cell therapies are gaining significant traction across industry and investors, reflecting a broader shift toward scalable, accessible cell therapy solutions.  

The UK MHRA was selected for its strong track record in advanced therapy approvals and its collaborative early-phase regulatory pathways, providing an efficient and supportive environment for pioneering modalities such as TCR-NK therapies.

About the ZIMA-101 trial: 

The Phase I clinical trial will evaluate ZI-MA4-1 in patients with advanced solid tumours including ovarian cancer, head-and-neck cancer, squamous non-small-cell lung cancer, and synovial sarcoma. The study will assess safety, tolerability and early signs of efficacy with initial data expected mid-2026 (subject to regulatory approval).

The trial will be led by Prof. Fiona Thistlethwaite at The Christie NHS Foundation Trust (Manchester, UK) with participation from Dr. Andrew Furness at The Royal Marsden (London, UK), both world leading centres for oncology and early-phase cell therapy clinical research.

“This is an exciting moment, the submission of the CTA is a huge step towards bringing the ZIMA-101 study into the clinic, ” said Prof. Thistlethwaite, Medical Oncology Consultant within the Experimental Cancer Medicines Team, Clinical Lead for the Advanced Immunotherapy and Cell Therapy Team, The Christie, and Chief Investigator for the ZIMA-101 trial. “I am optimistic that combining the broad tumour-recognition and innate killing activity of NK cells with a tumour antigen directed TCR will provide us with the step-change that we need in the solid tumour setting to provide the required level of tumour potency whilst avoiding tumour escape.”

ZI-MA4-1 has broad intellectual property coverage, including a landmark granted patent providing dominant protection for Zelluna over the entire TCR-NK field.

About Zelluna ASA
Zelluna ASA (OSE: ZLNA) is a pioneering allogeneic ‘off-the-shelf’ T Cell Receptor-based Natural Killer (TCR-NK) cells for the treatment of solid cancers. The company’s platform combines the innate killing power of NK cells with precise  solid tumour targeting of TCRs, designed to address the limitations of current cell therapies in solid tumours. The company’s lead candidate, ZI-MA4-1, is the worlds-first MAGE-A4 targeting TCR-NK therapy expected to enter clinical trials in 2026. Zelluna is headquartered at the Oslo Cancer Cluster innovation Park in Oslo, Norway and is listed on the Oslo Stock Exchange under the ticker ZLNA.

For further information, please contact:

Namir Hassan, CEO, Zelluna ASA
Email: namir.hassan@zelluna.com
Phone: +44 7720 687608

Anders Tuv, Chairman, Zelluna ASA
Email: at@radforsk.no
Phone: +47 982 06 826

International media:
Frazer Hall/Mark Swallow – MEDiSTRAVA
Email: zelluna@medistrava.com

This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Securities Trading Act.

This stock exchange announcement was published by Geir Christian Melen, Finance Director of Zelluna ASA, on 17 December 2025 at 17.23 CET.

Peptinovo Biopharma in Collaboration with Chemelectiva Announces Breakthrough Manufacturing Innovation for Targeted Chemotherapy




Peptinovo Biopharma in Collaboration with Chemelectiva Announces Breakthrough Manufacturing Innovation for Targeted Chemotherapy

First-of-its-kind semi-synthetic vitamin E product enables scalable, FDA-compliant production of Peptinovo’s proprietary cancer prodrugs

ANN ARBOR, Mich., Dec. 17, 2025 (GLOBE NEWSWIRE) — Peptinovo Biopharma, an Ann Arbor–based biotechnology company pioneering targeted cancer therapies through its proprietary PALM™ nanotechnology, today announced a major manufacturing and intellectual property milestone achieved in collaboration with Chemelectiva S.r.l., an Italian specialty pharmaceutical chemistry company. The breakthrough significantly advances Peptinovo’s proprietary prodrug platform for targeted chemotherapy delivery.

Through the collaboration, Peptinovo and Chemelectiva developed and scaled a first-of-its-kind semi-synthetic vitamin E compound that is central to Peptinovo’s technology. The innovation enables FDA-compliant manufacturing at commercial scale, overcoming the limitations of naturally sourced materials and strengthening the platform’s path from clinical development to commercialization. Peptinovo is nearing clinical trials.

“This innovation began with a fundamental challenge,” said Steve Tokarz, CEO of Peptinovo Biopharma. “We needed a reliable, scalable way to manufacture a critical vitamin E–based linker at the heart of our prodrug platform. By creating this chemistry from the ground up with Chemelectiva, we unlocked a defensible, FDA-approvable process that meaningfully advances targeted chemotherapy delivery for patients.”

Placing Peptinovo in the Evolution of Targeted Chemotherapy

Over the past decade, antibody-drug conjugates (ADCs) have represented a major advance in cancer treatment by attaching potent chemotherapy agents to antibodies that recognize specific tumor markers. While ADCs have improved targeting for certain cancers, their complexity, manufacturing challenges, and dependence on specific antigens limit their applicability across tumor types.

Peptinovo’s approach builds on the same goal – delivering chemotherapy more precisely – while using a non-antibody, small-molecule prodrug strategy designed for broader applicability and scalable manufacturing.

A prodrug is an inactive or less active compound that the body converts into its active drug form through metabolic processes. Peptinovo’s platform uses a vitamin E–based linker to temporarily deactivate standard chemotherapeutic agents, allowing them to circulate safely until they reach cancer cells, where the drug is reactivated once inside the cell. This approach preserves therapeutic efficacy while reducing or eliminating many of the side effects associated with conventional chemotherapy.

Unlike antibody-drug conjugates, Peptinovo’s linker chemistry is a simple chemical construct using a single carbon and a single oxygen bond which can be applied to more than 60% of known chemotherapeutic agents as well as new chemotherapies that were once too toxic for patient treatment – significantly expanding its potential across cancer types and indications.

The breakthrough was made possible by Chemelectiva’s development of a novel, patented synthetic route for the vitamin E compound, chemistry that did not previously exist at pharmaceutical manufacturing scale.

“No one had successfully developed a semi-synthetic version of this compound suitable for pharmaceutical production,” Chemelectiva Founder and CEO Graziano Castaldi said. “We designed and patented new synthesis pathways that allow Peptinovo to access this critical molecule at the quality, scale, and cost required for clinical and future commercial use.”

The collaboration, which began in 2021, resulted in patented manufacturing technologies that now form a core component of Peptinovo’s intellectual property portfolio and support both current clinical programs and future pipeline expansion.

“Innovation doesn’t stop at discovery,” Glenn Meyer, Peptinovo Head of Product Development, said. “Manufacturability, scalability, and intellectual property are essential to translating science into real-world impact. This milestone strengthens Peptinovo’s platform and accelerates our ability to deliver better cancer treatments to patients.”

About Peptinovo Biopharma

Peptinovo Biopharma is a privately held biotechnology company based in Ann Arbor, Michigan, developing next-generation targeted nanomedicines to enhance the treatment of cancer. Its proprietary PALM™ technology delivers proven chemotherapies directly to tumors while reducing toxicity to healthy tissues, aiming to improve outcomes and quality of life for patients. The company has raised $16.8M to date and is raising additional funds in its current Series A round to expand development of its platform. Peptinovo is reaching a significant inflection point at a very attractive valuation. For more information, go to the company’s Reg CF investor portal. For more information, visit www.peptinovo.com.

Peptinovo Investor Relations Contact
Steve Tokarz
steve.tokarz@peptinovo.com

Peptinovo Media Contact
Katie Merx
katiemerx@gmail.com
+1 313.510.5090

Tiziana Life Sciences to Ring the Closing Bell at Nasdaq




Tiziana Life Sciences to Ring the Closing Bell at Nasdaq

BOSTON, Dec. 17, 2025 (GLOBE NEWSWIRE) — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces that Executive Chairman and Founder, Gabriele Cerrone will ring the Closing Bell at the Nasdaq MarketSite in Times Square, New York today.

The ceremony, will be held from 3:45 PM to 4:15 PM ET, celebrates Tiziana’s ongoing advancements in innovative treatments, including its lead candidate intranasal foralumab, a fully human anti-CD3 monoclonal antibody. The company’s pioneering nasal delivery approach aims to provide improved efficacy, safety, and tolerability compared to traditional intravenous methods, targeting neurodegenerative and inflammatory diseases such as multiple sclerosis, Alzheimer’s disease, and ALS.

“This is a proud milestone for Tiziana Life Sciences and a testament to the dedication of our team, partners, and investors,” said Gabriele Cerrone, Executive Chairman and Founder of Tiziana Life Sciences. “Ringing the Nasdaq Closing Bell is a powerful celebration of the hard work and dedication of our exceptional team who are tirelessly working to transform patient outcomes through groundbreaking immunomodulation therapies. We are excited about the future as we advance our clinical programs and deliver on our mission to address unmet medical needs.”

Tiziana Life Sciences continues to progress its pipeline, with recent achievements including the dosing of the first patient in its Phase 2 Alzheimer’s trial and expansions in other key studies.

For more information about the event, visit: https://www.nasdaq.com/events/tiziana-life-sciences-rings-closing-bell

Ceremony Livestream Link: https://www.nasdaq.com/marketsite/bell-ringing-ceremony

About Foralumab

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).

Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.^[1],[2]

About Tiziana Life Sciences

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative intranasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.

For further inquiries:

Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com

[1] https://www.pnas.org/doi/10.1073/pnas.2220272120

[2] https://www.pnas.org/doi/10.1073/pnas.2309221120

SAB BIO Announces Positive Confirmatory Clinical Results from the Phase 1 Study of SAB-142 in Development for the Treatment of Stage 3 T1D




SAB BIO Announces Positive Confirmatory Clinical Results from the Phase 1 Study of SAB-142 in Development for the Treatment of Stage 3 T1D

• Phase 1 data confirms SAB-142 does not cause serum sickness and has low/no immunogenicity at any dose and in all cohorts, including redosed healthy volunteers
• Study results support the chronic dosing of SAB-142 in an outpatient setting for the treatment of stage 3 autoimmune type 1 diabetes
• Phase 2b SAFEGUARD trial underway and recruiting at multiple sites around the world

MIAMI, Dec. 17, 2025 (GLOBE NEWSWIRE) — SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company developing human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other autoimmune diseases, today announced positive, confirmatory data from a Phase 1 trial of SAB-142 in a single- and multiple-ascending dose among healthy volunteers (n=62), including a re-dosed cohort, and T1D patients (n=6). The study met its primary objectives to establish a safety profile and characterize pharmacodynamic activity enabling SAB-142 to advance to Phase 2b clinical development in the SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes (SAFEGUARD) clinical trial, now underway.

In the Phase 1 trial, nine (9) cohorts of healthy volunteers (HVs) and one (1) cohort of T1D patients were dosed with a single 0.03-4.5mg/kg dose or multiple doses of SAB-142.

SAB-142 was well-tolerated in both healthy volunteers and T1D patients. SAB-142 demonstrates a safety profile superior to rabbit anti-thymocyte immunoglobulin (rATG) as the data from the Phase 1 trial confirmed SAB-142 does not cause serum sickness (0%, N=0/68) and there were no adverse events (AEs) associated with anti-drug antibodies (ADAs; 0%, N=0/68) at any dose in any cohort, including in the redosed HVs.

In all treated participants, there were no drug-related serious adverse events (SAE). Most AEs were mild and associated with day 1-2 infusions, with only Grade 1 flu-like symptoms and transient infusion-site reactions including pruritus and tenderness. The most common AE was headache, which is consistent with typical AEs for T-cell modifying therapies.

Transient lymphopenia, an on-target marker of target engagement and pharmacodynamic activity, was observed after dosing and rapidly corrected to baseline within 1-3 days in all subjects (100%; N=68), including after the second administration in the redosed HV cohort (100%; n=8) and are comparable to placebo. Unlike other immunomodulatory drugs that deplete lymphocytes for up to two years, the lack of sustained lymphodepletion for SAB-142, as shown in Table 1 below, SAB-142 has the potential to be safely redosed. 

Table 1

“These promising Phase 1 data support our belief that SAB-142 is emerging as a potential best-in-class, redosable treatment for delaying progression of stage 3 T1D. All results have met or exceeded our expectations, allowing us to move swiftly into our registrational Phase 2b SAFGUARD study,” said Alexandra Kropotova, M.D., MBA, Chief Medical Officer, SAB BIO. “I would like to thank the clinical trial participants, their families, the clinicians, and our colleagues at collaborating institutions for their invaluable contributions to our clinical trials. We look forward to sharing updates from the SAFEGUARD trial over the next two years.”

“This investigational therapy has been well-tolerated throughout the Phase 1 study, and we look forward to evaluating its effectiveness in new onset T1D. Novel treatment options that can meaningfully alter the course of disease are urgently needed,” said Michael J. Haller, M.D., Professor and Chief of Pediatric Endocrinology, University of Florida. “I am excited about the prospect for benefit with SAB-142 in patients with T1D, and I look forward to leading the SAFEGUARD Phase 2b trial.”

Based on these data, SAB BIO has advanced SAB-142 into a registrational Phase 2b trial SAFEGUARD to evaluate SAB-142 in adult and pediatric patients with new-onset, stage 3 T1D. The SAFEGUARD trial is enrolling at multiple sites around the world, and the Company is on track to dose the first patient by the end of the year.

About the Phase 1 Trial of SAB-142
The Phase 1 trial of SAB-142 is a randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study among healthy volunteers and one cohort of participants with T1D. The study objectives include establishing safety, tolerability, pharmacokinetic (PK), immunogenicity, and pharmacodynamic (PD) profile for SAB-142 with a single 0.03-4.5mg/kg dose plus one cohort with an additional 1.5mg/kg dose.

About SAB-142
SAB-142 is a potentially disease-modifying, redosable immunotherapy in clinical development for the treatment of autoimmune type 1 diabetes (T1D). SAB-142 is a multi-specific, fully human anti-thymocyte globulin (hATG) with a mechanism of action analogous to that of rabbit ATG (rATG). rATG has demonstrated in multiple clinical trials the ability to slow disease progression in patients with new- or recent-onset of Stage 3 T1D. SAB-142, like rATG, directly targets multiple immune cells involved in destroying pancreatic beta cells, including modulation of “bad acting” T-lymphocytes like cytotoxic T-cells. By stopping immune cells from attacking beta cells, this treatment has the potential to preserve insulin-producing beta cells.

About SAB BIO
SAB BIO is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency, human immunoglobulin G (hIgG) to treat and prevent immune and autoimmune disorders. The Company’s lead candidate, SAB-142, targets autoimmune T1D with a disease-modifying therapeutic approach that aims to change the T1D treatment paradigm by delaying onset and potentially preventing disease progression of Stage 3 T1D patients. Using advanced genetic engineering and antibody science, SAB BIO developed a proprietary technology which holds the potential to generate additional novel therapeutic candidates utilizing the human immune response, without the need for human donors or convalescent plasma. SAB BIO has optimized genetic engineering in the development of transchromosomic cattle, or Tc-Bovine™, to produce hIgG. SAB BIO’s drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, hIgGs that can address a wide range of serious unmet needs in human diseases. For more information, visit www.sab.bio.

Forward-Looking Statements
Certain statements made in this current report that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “to be,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, including statements about the development and clinical trial results of the Company’s T1D program and other discovery programs.

These statements are based on the current expectations of SAB BIO and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry’s results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned “Risk Factors” in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, as may be amended or supplemented from time to time, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at https://www.sec.gov/. Except as otherwise required by law, SAB BIO disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise.

CONTACTS

Investor Relations:
Cristi Barnett
ir@sab.bio

Media:
Sheila Carlson
media@sab.bio

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/56c69165-5952-46ec-adb4-af37827914a8

SAB BIO Announces Positive Confirmatory Clinical Results from the Phase 1 Study of SAB-142 in Development for the Treatment of Stage 3 T1D




SAB BIO Announces Positive Confirmatory Clinical Results from the Phase 1 Study of SAB-142 in Development for the Treatment of Stage 3 T1D

• Phase 1 data confirms SAB-142 does not cause serum sickness and has low/no immunogenicity at any dose and in all cohorts, including redosed healthy volunteers
• Study results support the chronic dosing of SAB-142 in an outpatient setting for the treatment of stage 3 autoimmune type 1 diabetes
• Phase 2b SAFEGUARD trial underway and recruiting at multiple sites around the world

MIAMI, Dec. 17, 2025 (GLOBE NEWSWIRE) — SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company developing human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other autoimmune diseases, today announced positive, confirmatory data from a Phase 1 trial of SAB-142 in a single- and multiple-ascending dose among healthy volunteers (n=62), including a re-dosed cohort, and T1D patients (n=6). The study met its primary objectives to establish a safety profile and characterize pharmacodynamic activity enabling SAB-142 to advance to Phase 2b clinical development in the SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes (SAFEGUARD) clinical trial, now underway.

In the Phase 1 trial, nine (9) cohorts of healthy volunteers (HVs) and one (1) cohort of T1D patients were dosed with a single 0.03-4.5mg/kg dose or multiple doses of SAB-142.

SAB-142 was well-tolerated in both healthy volunteers and T1D patients. SAB-142 demonstrates a safety profile superior to rabbit anti-thymocyte immunoglobulin (rATG) as the data from the Phase 1 trial confirmed SAB-142 does not cause serum sickness (0%, N=0/68) and there were no adverse events (AEs) associated with anti-drug antibodies (ADAs; 0%, N=0/68) at any dose in any cohort, including in the redosed HVs.

In all treated participants, there were no drug-related serious adverse events (SAE). Most AEs were mild and associated with day 1-2 infusions, with only Grade 1 flu-like symptoms and transient infusion-site reactions including pruritus and tenderness. The most common AE was headache, which is consistent with typical AEs for T-cell modifying therapies.

Transient lymphopenia, an on-target marker of target engagement and pharmacodynamic activity, was observed after dosing and rapidly corrected to baseline within 1-3 days in all subjects (100%; N=68), including after the second administration in the redosed HV cohort (100%; n=8) and are comparable to placebo. Unlike other immunomodulatory drugs that deplete lymphocytes for up to two years, the lack of sustained lymphodepletion for SAB-142, as shown in Table 1 below, SAB-142 has the potential to be safely redosed. 

Table 1

“These promising Phase 1 data support our belief that SAB-142 is emerging as a potential best-in-class, redosable treatment for delaying progression of stage 3 T1D. All results have met or exceeded our expectations, allowing us to move swiftly into our registrational Phase 2b SAFGUARD study,” said Alexandra Kropotova, M.D., MBA, Chief Medical Officer, SAB BIO. “I would like to thank the clinical trial participants, their families, the clinicians, and our colleagues at collaborating institutions for their invaluable contributions to our clinical trials. We look forward to sharing updates from the SAFEGUARD trial over the next two years.”

“This investigational therapy has been well-tolerated throughout the Phase 1 study, and we look forward to evaluating its effectiveness in new onset T1D. Novel treatment options that can meaningfully alter the course of disease are urgently needed,” said Michael J. Haller, M.D., Professor and Chief of Pediatric Endocrinology, University of Florida. “I am excited about the prospect for benefit with SAB-142 in patients with T1D, and I look forward to leading the SAFEGUARD Phase 2b trial.”

Based on these data, SAB BIO has advanced SAB-142 into a registrational Phase 2b trial SAFEGUARD to evaluate SAB-142 in adult and pediatric patients with new-onset, stage 3 T1D. The SAFEGUARD trial is enrolling at multiple sites around the world, and the Company is on track to dose the first patient by the end of the year.

About the Phase 1 Trial of SAB-142
The Phase 1 trial of SAB-142 is a randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study among healthy volunteers and one cohort of participants with T1D. The study objectives include establishing safety, tolerability, pharmacokinetic (PK), immunogenicity, and pharmacodynamic (PD) profile for SAB-142 with a single 0.03-4.5mg/kg dose plus one cohort with an additional 1.5mg/kg dose.

About SAB-142
SAB-142 is a potentially disease-modifying, redosable immunotherapy in clinical development for the treatment of autoimmune type 1 diabetes (T1D). SAB-142 is a multi-specific, fully human anti-thymocyte globulin (hATG) with a mechanism of action analogous to that of rabbit ATG (rATG). rATG has demonstrated in multiple clinical trials the ability to slow disease progression in patients with new- or recent-onset of Stage 3 T1D. SAB-142, like rATG, directly targets multiple immune cells involved in destroying pancreatic beta cells, including modulation of “bad acting” T-lymphocytes like cytotoxic T-cells. By stopping immune cells from attacking beta cells, this treatment has the potential to preserve insulin-producing beta cells.

About SAB BIO
SAB BIO is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency, human immunoglobulin G (hIgG) to treat and prevent immune and autoimmune disorders. The Company’s lead candidate, SAB-142, targets autoimmune T1D with a disease-modifying therapeutic approach that aims to change the T1D treatment paradigm by delaying onset and potentially preventing disease progression of Stage 3 T1D patients. Using advanced genetic engineering and antibody science, SAB BIO developed a proprietary technology which holds the potential to generate additional novel therapeutic candidates utilizing the human immune response, without the need for human donors or convalescent plasma. SAB BIO has optimized genetic engineering in the development of transchromosomic cattle, or Tc-Bovine™, to produce hIgG. SAB BIO’s drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, hIgGs that can address a wide range of serious unmet needs in human diseases. For more information, visit www.sab.bio.

Forward-Looking Statements
Certain statements made in this current report that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “to be,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, including statements about the development and clinical trial results of the Company’s T1D program and other discovery programs.

These statements are based on the current expectations of SAB BIO and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry’s results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned “Risk Factors” in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, as may be amended or supplemented from time to time, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at https://www.sec.gov/. Except as otherwise required by law, SAB BIO disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise.

CONTACTS

Investor Relations:
Cristi Barnett
ir@sab.bio

Media:
Sheila Carlson
media@sab.bio

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/56c69165-5952-46ec-adb4-af37827914a8

TadHealth Awarded San Diego County Office of Education Contract; School Districts to Begin CYBHI Billing in January 2026




TadHealth Awarded San Diego County Office of Education Contract; School Districts to Begin CYBHI Billing in January 2026

COSTA MESA, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) — TadHealth, a leading provider of school-based mental health technology, has been selected by the San Diego County Office of Education (SDCOE) to deliver a county-wide Student Electronic Health Record (EHR) system in support of California’s Children and Youth Behavioral Health Initiative (CYBHI). The contract ensures that all participating school districts across San Diego County will be able to begin billing for eligible CYBHI services starting January 2026.

This award follows a competitive Request for Proposal (RFP) process and marks a major milestone in scaling accessible, coordinated mental health care for students. The CYBHI, a multi-billion-dollar statewide initiative, aims to build a more integrated and equitable behavioral health system for youth. Through this partnership, Local Education Agencies (LEAs) in the county will gain access to a purpose-built platform that supports CYBHI reimbursements while also streamlining referrals, documentation, and data tracking for school-based mental health professionals.

“This is more than a technology implementation, it’s a step toward reimagining school mental health across California,” said Ben Greiner, CEO of TadHealth. “We are honored to partner with SDCOE, a truly forward-thinking county office that understands the opportunity CYBHI brings for students and families. Together, we’re bringing this vision to life, ensuring every student has better access to care and schools have the tools they need to support them.”

“Our partnership with TadHealth, made possible by funding through the CYBHI School-Linked Partnership and Capacity Grant, is an essential part of our commitment to supporting the behavioral health needs of students across our county. Our efforts will create more resources for a connected and coordinated approach to student well-being. This partnership allows us to meet students where they are, ensures timely support, and builds healthier school communities across San Diego County,” said Mara Madrigal-Weiss, Executive Director of Student Wellness & School Culture, San Diego County Office of Education.

CYBHI is part of the Master Plan for Kids’ Mental Health, a historic investment by the State of California that takes a “whole child” approach to address the factors that contribute to the mental health and well-being of the state’s children and youth. CYBHI is a game-changer for California schools, and TadHealth empowers schools to focus on students, not paperwork.

Supporting 1,000+ providers and over 300,000 students across California, TadHealth is allowing schools to get reimbursed for the first time in history, thus unlocking funds for schools to sustain and scale their mental health programs through CYBHI. TadHealth recently announced that Anaheim Elementary School District has received over $800K in funds, demonstrating the power and impact of the platform.

With soaring mental health needs and tight budgets, schools can tap managed care funds to sustain programs and jobs. TadHealth’s secure, compliant platform ensures full reimbursement within 45 days, with the majority of CYBHI claims statewide filed through the platform.

With this San Diego contract, TadHealth becomes the student EHR solution of record for one of the largest and most innovative counties in California, serving more than 500,000 students across 42 school districts.

About TadHealth
TadHealth is a purpose-built, advanced electronic health record platform designed specifically for K-12 schools. Created in collaboration with educators and mental health experts, TadHealth is powering the future of student mental health by helping over 300,000 students get the support they need—when they need it.

Media Contact

Glenn Mandel
Firecracker PR
760-798-1563
glenn@firecrackerpr.com

TadHealth Awarded San Diego County Office of Education Contract; School Districts to Begin CYBHI Billing in January 2026




TadHealth Awarded San Diego County Office of Education Contract; School Districts to Begin CYBHI Billing in January 2026

COSTA MESA, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) — TadHealth, a leading provider of school-based mental health technology, has been selected by the San Diego County Office of Education (SDCOE) to deliver a county-wide Student Electronic Health Record (EHR) system in support of California’s Children and Youth Behavioral Health Initiative (CYBHI). The contract ensures that all participating school districts across San Diego County will be able to begin billing for eligible CYBHI services starting January 2026.

This award follows a competitive Request for Proposal (RFP) process and marks a major milestone in scaling accessible, coordinated mental health care for students. The CYBHI, a multi-billion-dollar statewide initiative, aims to build a more integrated and equitable behavioral health system for youth. Through this partnership, Local Education Agencies (LEAs) in the county will gain access to a purpose-built platform that supports CYBHI reimbursements while also streamlining referrals, documentation, and data tracking for school-based mental health professionals.

“This is more than a technology implementation, it’s a step toward reimagining school mental health across California,” said Ben Greiner, CEO of TadHealth. “We are honored to partner with SDCOE, a truly forward-thinking county office that understands the opportunity CYBHI brings for students and families. Together, we’re bringing this vision to life, ensuring every student has better access to care and schools have the tools they need to support them.”

“Our partnership with TadHealth, made possible by funding through the CYBHI School-Linked Partnership and Capacity Grant, is an essential part of our commitment to supporting the behavioral health needs of students across our county. Our efforts will create more resources for a connected and coordinated approach to student well-being. This partnership allows us to meet students where they are, ensures timely support, and builds healthier school communities across San Diego County,” said Mara Madrigal-Weiss, Executive Director of Student Wellness & School Culture, San Diego County Office of Education.

CYBHI is part of the Master Plan for Kids’ Mental Health, a historic investment by the State of California that takes a “whole child” approach to address the factors that contribute to the mental health and well-being of the state’s children and youth. CYBHI is a game-changer for California schools, and TadHealth empowers schools to focus on students, not paperwork.

Supporting 1,000+ providers and over 300,000 students across California, TadHealth is allowing schools to get reimbursed for the first time in history, thus unlocking funds for schools to sustain and scale their mental health programs through CYBHI. TadHealth recently announced that Anaheim Elementary School District has received over $800K in funds, demonstrating the power and impact of the platform.

With soaring mental health needs and tight budgets, schools can tap managed care funds to sustain programs and jobs. TadHealth’s secure, compliant platform ensures full reimbursement within 45 days, with the majority of CYBHI claims statewide filed through the platform.

With this San Diego contract, TadHealth becomes the student EHR solution of record for one of the largest and most innovative counties in California, serving more than 500,000 students across 42 school districts.

About TadHealth
TadHealth is a purpose-built, advanced electronic health record platform designed specifically for K-12 schools. Created in collaboration with educators and mental health experts, TadHealth is powering the future of student mental health by helping over 300,000 students get the support they need—when they need it.

Media Contact

Glenn Mandel
Firecracker PR
760-798-1563
glenn@firecrackerpr.com

VYNE Therapeutics and Yarrow Bioscience Announce Merger Agreement 




VYNE Therapeutics and Yarrow Bioscience Announce Merger Agreement 

• Following closing, combined company plans to progress Yarrow’s lead program, YB-101, a potentially first-in-class anti-thyroid-stimulating hormone receptor (“TSHR”) antibody for Graves’ disease (“GD”) and thyroid eye disease (“TED”)
• Yarrow Bioscience is the seventh biotechnology company founded by RTW Investments and plans to advance in-licensed asset YB-101 (also known as GS-098) into a U.S.-based Phase 1b/2b trial in patients with GD in the first half of 2026; a Phase 1 trial in TED is being conducted in China by partner Changchun GeneScience Pharmaceutical Co., Ltd (“GenSci”)
• Pre-closing private financings totaling approximately $200 million expected to fund operations into 2028
• Companies to hold conference call on December 17, 2025 at 8:30AM EDT

NEW YORK, Dec. 17, 2025 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE”) and Yarrow Bioscience, Inc. (“Yarrow”) today announced that they have entered into a definitive merger agreement pursuant to which the companies will combine in an all-stock transaction (the “Merger”). Upon completion of the Merger, the combined company expects to operate as Yarrow Bioscience, Inc. and trade on Nasdaq under the ticker symbol “YARW”. Following completion of the Merger, the combined company plans to focus on advancing YB-101 (also known as GS-098), a clinical-stage, potentially first-in-class TSHR antibody for the treatment of GD and TED.

In support of the Merger, a syndicate of industry-leading healthcare investors led by RTW Investments, with participation from OrbiMed, Janus Henderson Investors, venBio Partners, Logos Capital, LifeSci Venture Partners and Perceptive Advisors, has committed to pre-closing financings in Yarrow totaling approximately $200.0 million in cash proceeds.

The combined company’s cash balance at closing is expected to fund operations into 2028, including the advancement of the combined company’s lead program YB-101, into a Phase 1b/2b trial in patients with GD, which is expected to be conducted in the United States and other territories. Phase 1b data is expected in the second half of 2027. In parallel, a Phase 1 trial, which is being conducted by licensing partner GenSci, is evaluating the safety and efficacy of YB-101 in patients with TED in China.

Prior to closing, VYNE expects to declare a cash dividend to pre-Merger VYNE stockholders to distribute excess net cash, which is expected to be approximately $14.5 to $16.5 million.

“We are excited about this merger, which establishes Yarrow on a strong foundation to advance YB-101 for patients living with Graves’ disease and thyroid eye disease,” said Rebecca Frey, Pharm.D., President and Chief Executive Officer of Yarrow. “Autoimmune thyroid disorders represent areas of significant unmet need, and we believe YB-101 has the potential to deliver meaningful clinical benefit through its highly targeted TSHR-directed mechanism of action. Together with an exceptional leadership team and the support of a premier group of life sciences investors, Yarrow is well positioned to deliver on our mission to transform treatment options in this field.”

“Over the last several months, VYNE has evaluated a wide range of options to maximize stockholder value, including an assessment of our internal pipeline, financing opportunities and strategic alternatives,” said David Domzalski, President and Chief Executive Officer of VYNE. “We believe this merger provides our stockholders a compelling opportunity to realize both short- and long-term value creation through a cash dividend and the continued advancement of Yarrow’s potential breakthrough therapies for the treatment of thyroid autoimmune diseases.”

About YB-101

YB-101 (also known as GS-098) is a clinical-stage, humanized monoclonal antibody targeting the thyroid-stimulating hormone receptor (TSHR). The antibody is designed to rapidly and efficiently block the pathogenic activity of thyroid-stimulating autoantibodies that drive disease progression in Graves’ disease (GD) and thyroid eye disease (TED). By binding selectively to the TSH receptor and blocking autoantibody-induced receptor activation, YB-101 directly inhibits the biological pathway responsible for hyperthyroidism and orbitopathy. This novel and targeted approach represents a potential breakthrough for patients who are inadequately controlled with first-line therapies and remain at high risk for complications of GD and TED. While existing IGF-1R–directed therapies have demonstrated clinical benefit in TED, their broad receptor expression has been associated with treatment-limiting adverse events in certain patients. YB-101 targets the thyroid-stimulating hormone receptor, a key disease-driving pathway with more restricted tissue expression, and is designed to directly inhibit pathogenic autoantibody activity. This targeted approach has the potential to address an important unmet need for therapies with differentiated risk-benefit profiles. Earlier this week, Yarrow executed an exclusive license agreement with Shanghai Scizeng Medical Technology Co., Ltd, an affiliate of GenSci, to obtain global ex-China rights to develop GS-098 in GD and TED.

About the Proposed Transactions

Under the terms of the merger agreement, the pre-Merger VYNE stockholders are expected to own approximately 3% of the combined company, and the pre-Merger Yarrow stockholders (inclusive of those investors participating in the financings described above) are expected to own approximately 97% of the combined company, which is subject to adjustment in accordance with the definitive merger agreement.

The Merger has received unanimous approval by the boards of directors of both companies and is expected to close in the second quarter of 2026, subject to certain closing conditions, including, among other things, approval by the stockholders of each company, the effectiveness of a registration statement on Form S-4 to be filed with the U.S. Securities and Exchange Commission (the “SEC”) to register the securities to be issued in connection with the Merger and the satisfaction of other customary closing conditions.

The combined company will be named “Yarrow Bioscience, Inc.” and be led by Rebecca Frey, Yarrow’s Chief Executive Officer and a member of Yarrow’s board of directors. In addition, Lori Payton, Ph.D. is joining Yarrow’s management team as Chief Development Officer.

Advisory and Legal Counsel

Gibson, Dunn & Crutcher LLP is serving as legal counsel to Yarrow, while Wedbush Securities Inc. is serving as exclusive strategic financial advisor. Cooley LLP is serving as legal counsel to VYNE and LifeSci Capital is serving as exclusive financial advisor.

Conference Call Details

Yarrow and VYNE plan to hold a joint conference call on December 17, 2025 at 8:30 AM EDT to discuss the Merger in more detail. To join the webcast, please register here. A replay of the webcast can be accessed following the call by visiting www.vynetherapeutics.com.

About Yarrow Bioscience, Inc.

Yarrow Bioscience is a clinical-stage biotechnology company focused on developing transformative therapies for autoimmune thyroid diseases. The company’s lead candidate, YB-101, is a humanized monoclonal antibody targeting the thyroid-stimulating hormone receptor (TSHR) for the treatment of Graves’ disease and thyroid eye disease. Yarrow is headquartered in New York, NY, and is backed by leading healthcare investors, including RTW Investments.

For more information, please visit www.yarrowbioscience.com.

About VYNE Therapeutics Inc.

VYNE is a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat inflammatory and immune-mediated conditions with high unmet need. VYNE’s unique and proprietary BET inhibitors, which comprise its InhiBET™ platform, are designed to overcome limitations of early generation BET inhibitors by leveraging alternative routes of administration and enhanced selectivity.

For more information, please visit www.vynetherapeutics.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the structure, timing and completion of the proposed Merger; the combined companies’ cash position after closing of the proposed Merger and cash runway of the combined company; the combined company’s listing on Nasdaq after closing of the proposed Merger; expectations regarding the ownership structure of the combined company; the anticipated timing of closing; the expected executive officers of the combined company; the future operations of the combined company; the nature, strategy and focus of the combined company; the development and commercial potential and potential benefits of any product candidates of the combined company; anticipated clinical drug development activities and related timelines, including the expected timing for trial initiation, data and other clinical results; and other statements that are not historical fact. Any forward-looking statements in this release are based on management’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. There can be no assurance that future developments affecting the combined company will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the combined company’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the conditions to the closing of the Merger are not satisfied, including the failure to timely obtain shareholder approval for the transaction, if at all; uncertainties as to the timing of the consummation of the Merger and the ability of each of VYNE and Yarrow to consummate the Merger; risks related to VYNE’s ability to manage its operating expenses and its expenses associated with the Merger pending closing; risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the Merger; the risk that as a result of adjustments to the exchange ratio, VYNE shareholders and Yarrow stockholders could own more or less of the combined company than is currently anticipated; risks related to the market price of VYNE’s common stock relative to the value suggested by the exchange ratio; unexpected costs, charges or expenses resulting from the transaction; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Merger; the uncertainties associated with Yarrow’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks associated with the possible failure to realize certain anticipated benefits of the Merger, including with respect to future financial and operating results; the risk that the related financing is not consummated; and the risk that VYNE’s shareholders receive more or less of the cash dividend than is currently anticipated; and those uncertainties and factors described under the heading “Risk Factors” in VYNE’s Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, and VYNE’s other filings from time to time with the SEC. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. The combined company does not undertake or accept any duty to make any updates or revisions to any forward-looking statements.

NO OFFER OR SOLICITATION

This communication is not intended to and do not constitute (i) a solicitation of a proxy, consent or approval with respect to any securities or in respect of the proposed transaction or (ii) an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended, or an exemption therefrom. Subject to certain exceptions to be approved by the relevant regulators or certain facts to be ascertained, the public offer will not be made directly or indirectly, in or into any jurisdiction where to do so would constitute a violation of the laws of such jurisdiction, or by use of the mails or by any means or instrumentality (including without limitation, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or any facility of a national securities exchange, of any such jurisdiction.

NEITHER THE SEC NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THE SECURITIES OR DETERMINED IF THIS COMMUNICATION IS TRUTHFUL OR COMPLETE

IMPORTANT ADDITIONAL INFORMATION ABOUT THE PROPOSED TRANSACTION WILL BE FILED WITH THE SEC

This communication is not a substitute for any other document that VYNE may file with the SEC in connection with the proposed transaction, including the registration statement on Form S-4 (the “Form S-4”) that will contain a proxy statement and prospectus. In connection with the proposed transaction between VYNE, Yarrow and Merger Sub, VYNE intends to file relevant materials with the SEC, including the Form S-4. VYNE URGES INVESTORS AND STOCKHOLDERS TO READ THE REGISTRATION STATEMENT, INCLUDING THE PROXY STATEMENT/PROSPECTUS CONTAINED THEREIN, AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT VYNE, YARROW, MERGER SUB, THE PROPOSED TRANSACTION AND RELATED MATTERS. Investors and stockholders will be able to obtain free copies of the Form S-4 and other documents filed by VYNE with the SEC (when they become available) through the website maintained by the SEC at www.sec.gov. In addition, investors and stockholders should note that VYNE communicates with investors and the public using its website (www.vynetherapeutics.com) and the investor media website (https://vynetherapeutics.com/investors-media) where anyone will be able to obtain free copies of the Form S-4 and included proxy statement/prospectus and other documents filed by VYNE with the SEC and stockholders are urged to read the Form S-4 and included proxy statement/prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction.

PARTICIPANTS IN THE SOLICITATION

VYNE, Yarrow and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from stockholders in connection with the proposed transaction. Information about VYNE’s directors and executive officers, including a description of their interests in VYNE, is included in VYNE’s most recent definitive proxy statement, as filed with the SEC on November 12, 2025. Additional information regarding these persons and their interests in the proposed transaction will be included in the proxy statement/prospectus relating to the proposed transaction when it is filed with the SEC. These documents can be obtained free of charge from the sources indicated above.

Third-party products and company names mentioned herein may be the trademarks of their respective owners.

Yarrow Media Contact:
Ten Bridge Communications
TBCYarrow@tenbridgecommunications.com

VYNE Investor Relations:
John Fraunces
LifeSci Advisors, LLC
jfraunces@lifesciadvisors.com

Processa Pharmaceuticals Provides Clinical Update on Phase 2 Study in Metastatic Breast Cancer




Processa Pharmaceuticals Provides Clinical Update on Phase 2 Study in Metastatic Breast Cancer

Preliminary Phase 2 data demonstrate PCS6422+Capecitabine increased cancer-killing metabolite exposure while maintaining comparable safety to monotherapy capecitabine

Company on track to conduct formal interim analysis in early 2026

VERO BEACH, Fla., Dec. 17, 2025 (GLOBE NEWSWIRE) — Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies, today provided a clinical update on its ongoing Phase 2 study of NGC-Cap, the combination treatment of PCS6422 and capecitabine, in patients with advanced or metastatic breast cancer.

Data from the first 16 of 19 patients enrolled indicate that NGC-Cap significantly increases exposure to capecitabine cancer-killing drug metabolites without increasing the severity of side effects compared to standard monotherapy capecitabine therapy (Mono-Cap). This profile suggests the potential for improved clinical efficacy while maintaining manageable safety, a key objective of Processa’s NGC platform.

The full interim analysis from the first 20 patients enrolled in the study, which will include efficacy and safety data, is expected in early 2026.

“These emerging data continue to validate the central premise of our Next Generation Cancer strategy,” said Dr. David Young, President of Research and Development at Processa. “NGC-Cap (capecitabine combined with PCS6422) appears to meaningfully increase exposure to the capecitabine metabolites responsible for killing cancer cells, while reducing exposure to the catabolite metabolites associated with dose-limiting toxicity such as hand-foot-syndrome (HFS), a profile that is difficult to achieve with conventional Mono-Cap dosing.”

“As we approach our planned interim analysis, we believe NGC-Cap continues to demonstrate a differentiated pharmacologic profile that could meaningfully improve the therapeutic index of capecitabine-based therapy,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals. “We view this program as a key value driver for the Company and an important opportunity for patients with advanced or metastatic breast cancer.”

Preliminary Phase 2 study findings suggest that NGC-Cap may allow patients to receive greater exposure to the most effective cancer-killing components of therapy while avoiding increased severity of side effects commonly associated with standard treatment. The Company believes this balance between potential efficacy and tolerability is central to improving outcomes in patients with advanced breast cancer.

Key Safety and Pharmacokinetic Observations

19 patients have been randomized to receive either NGC-Cap (150 mg twice daily) or a standard-dose Mono-Cap (1,000 mg/m² twice daily). The evaluation of safety data from the first 16 patients provides preliminary findings consistent with higher exposure to active cancer-killing metabolites in the NGC-Cap arm. The data from all 19 patients were not available for this preliminary analysis.

As expected with increased exposure to active metabolites, a greater proportion of patients receiving NGC-Cap experienced side effects related to these capecitabine cancer-killing metabolites, and the total number of such side effects per patient was higher compared to patients receiving capecitabine alone. Importantly, the severity of these side effects was similar between treatment arms, indicating that the increased activity did not translate into more severe toxicity.

In addition to forming active metabolites, capecitabine is also broken down into catabolite metabolites, including FBAL, which are associated with certain side effects such as HFS. Patients receiving NGC-Cap demonstrated substantially lower exposure to FBAL — up to ten times less than with Mono-Cap.

Consistent with this reduced exposure, the number of patients reporting HFS was similar between treatment groups, but patients in the NGC-Cap arm experienced only mild (Grade 1) symptoms, while patients receiving capecitabine monotherapy experienced symptoms of greater severity (up to Grade 2).

“What we are seeing in patients aligns closely with our pharmacologic expectations,” added Dr. Young. “The distribution and severity of observed side effects are consistent with enhanced exposure to active cancer-killing metabolites and reduced formation of catabolites, including FBAL.”

Upcoming Clinical Milestone

Processa anticipates completing enrollment of the final patient in the formal 20-patient interim analysis of Phase 2 safety and efficacy study by the end of the first quarter of 2026, in accordance with the trial protocol.

About PCS6422+Cap (NGC-Cap)

NGC-Cap is Processa’s lead oncology asset and a key component of its Next Generation Cancer (NGC) platform. When administered, NGC-Cap is designed to increase systemic exposure to active cancer-killing anabolite metabolites while reducing formation of toxic catabolite metabolites, potentially improving the therapeutic index of Capecitabine-based therapy.

About Processa Pharmaceuticals, Inc.

Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. In addition to its core oncology programs, Processa is actively pursuing strategic partnerships for non-oncology assets to unlock additional value.

For more information, visit our website at www.processapharma.com.

Forward-Looking Statements

This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements.

Company Contact:
Patrick Lin
(925) 683-3218
plin@processapharma.com

Investor Relations:
Dave Gentry
RedChip Companies, Inc.
1-407-644-4256
PCSA@redchip.com

VYNE Therapeutics and Yarrow Bioscience Announce Merger Agreement 




VYNE Therapeutics and Yarrow Bioscience Announce Merger Agreement 

• Following closing, combined company plans to progress Yarrow’s lead program, YB-101, a potentially first-in-class anti-thyroid-stimulating hormone receptor (“TSHR”) antibody for Graves’ disease (“GD”) and thyroid eye disease (“TED”)
• Yarrow Bioscience is the seventh biotechnology company founded by RTW Investments and plans to advance in-licensed asset YB-101 (also known as GS-098) into a U.S.-based Phase 1b/2b trial in patients with GD in the first half of 2026; a Phase 1 trial in TED is being conducted in China by partner Changchun GeneScience Pharmaceutical Co., Ltd (“GenSci”)
• Pre-closing private financings totaling approximately $200 million expected to fund operations into 2028
• Companies to hold conference call on December 17, 2025 at 8:30AM EDT

NEW YORK, Dec. 17, 2025 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE”) and Yarrow Bioscience, Inc. (“Yarrow”) today announced that they have entered into a definitive merger agreement pursuant to which the companies will combine in an all-stock transaction (the “Merger”). Upon completion of the Merger, the combined company expects to operate as Yarrow Bioscience, Inc. and trade on Nasdaq under the ticker symbol “YARW”. Following completion of the Merger, the combined company plans to focus on advancing YB-101 (also known as GS-098), a clinical-stage, potentially first-in-class TSHR antibody for the treatment of GD and TED.

In support of the Merger, a syndicate of industry-leading healthcare investors led by RTW Investments, with participation from OrbiMed, Janus Henderson Investors, venBio Partners, Logos Capital, LifeSci Venture Partners and Perceptive Advisors, has committed to pre-closing financings in Yarrow totaling approximately $200.0 million in cash proceeds.

The combined company’s cash balance at closing is expected to fund operations into 2028, including the advancement of the combined company’s lead program YB-101, into a Phase 1b/2b trial in patients with GD, which is expected to be conducted in the United States and other territories. Phase 1b data is expected in the second half of 2027. In parallel, a Phase 1 trial, which is being conducted by licensing partner GenSci, is evaluating the safety and efficacy of YB-101 in patients with TED in China.

Prior to closing, VYNE expects to declare a cash dividend to pre-Merger VYNE stockholders to distribute excess net cash, which is expected to be approximately $14.5 to $16.5 million.

“We are excited about this merger, which establishes Yarrow on a strong foundation to advance YB-101 for patients living with Graves’ disease and thyroid eye disease,” said Rebecca Frey, Pharm.D., President and Chief Executive Officer of Yarrow. “Autoimmune thyroid disorders represent areas of significant unmet need, and we believe YB-101 has the potential to deliver meaningful clinical benefit through its highly targeted TSHR-directed mechanism of action. Together with an exceptional leadership team and the support of a premier group of life sciences investors, Yarrow is well positioned to deliver on our mission to transform treatment options in this field.”

“Over the last several months, VYNE has evaluated a wide range of options to maximize stockholder value, including an assessment of our internal pipeline, financing opportunities and strategic alternatives,” said David Domzalski, President and Chief Executive Officer of VYNE. “We believe this merger provides our stockholders a compelling opportunity to realize both short- and long-term value creation through a cash dividend and the continued advancement of Yarrow’s potential breakthrough therapies for the treatment of thyroid autoimmune diseases.”

About YB-101

YB-101 (also known as GS-098) is a clinical-stage, humanized monoclonal antibody targeting the thyroid-stimulating hormone receptor (TSHR). The antibody is designed to rapidly and efficiently block the pathogenic activity of thyroid-stimulating autoantibodies that drive disease progression in Graves’ disease (GD) and thyroid eye disease (TED). By binding selectively to the TSH receptor and blocking autoantibody-induced receptor activation, YB-101 directly inhibits the biological pathway responsible for hyperthyroidism and orbitopathy. This novel and targeted approach represents a potential breakthrough for patients who are inadequately controlled with first-line therapies and remain at high risk for complications of GD and TED. While existing IGF-1R–directed therapies have demonstrated clinical benefit in TED, their broad receptor expression has been associated with treatment-limiting adverse events in certain patients. YB-101 targets the thyroid-stimulating hormone receptor, a key disease-driving pathway with more restricted tissue expression, and is designed to directly inhibit pathogenic autoantibody activity. This targeted approach has the potential to address an important unmet need for therapies with differentiated risk-benefit profiles. Earlier this week, Yarrow executed an exclusive license agreement with Shanghai Scizeng Medical Technology Co., Ltd, an affiliate of GenSci, to obtain global ex-China rights to develop GS-098 in GD and TED.

About the Proposed Transactions

Under the terms of the merger agreement, the pre-Merger VYNE stockholders are expected to own approximately 3% of the combined company, and the pre-Merger Yarrow stockholders (inclusive of those investors participating in the financings described above) are expected to own approximately 97% of the combined company, which is subject to adjustment in accordance with the definitive merger agreement.

The Merger has received unanimous approval by the boards of directors of both companies and is expected to close in the second quarter of 2026, subject to certain closing conditions, including, among other things, approval by the stockholders of each company, the effectiveness of a registration statement on Form S-4 to be filed with the U.S. Securities and Exchange Commission (the “SEC”) to register the securities to be issued in connection with the Merger and the satisfaction of other customary closing conditions.

The combined company will be named “Yarrow Bioscience, Inc.” and be led by Rebecca Frey, Yarrow’s Chief Executive Officer and a member of Yarrow’s board of directors. In addition, Lori Payton, Ph.D. is joining Yarrow’s management team as Chief Development Officer.

Advisory and Legal Counsel

Gibson, Dunn & Crutcher LLP is serving as legal counsel to Yarrow, while Wedbush Securities Inc. is serving as exclusive strategic financial advisor. Cooley LLP is serving as legal counsel to VYNE and LifeSci Capital is serving as exclusive financial advisor.

Conference Call Details

Yarrow and VYNE plan to hold a joint conference call on December 17, 2025 at 8:30 AM EDT to discuss the Merger in more detail. To join the webcast, please register here. A replay of the webcast can be accessed following the call by visiting www.vynetherapeutics.com.

About Yarrow Bioscience, Inc.

Yarrow Bioscience is a clinical-stage biotechnology company focused on developing transformative therapies for autoimmune thyroid diseases. The company’s lead candidate, YB-101, is a humanized monoclonal antibody targeting the thyroid-stimulating hormone receptor (TSHR) for the treatment of Graves’ disease and thyroid eye disease. Yarrow is headquartered in New York, NY, and is backed by leading healthcare investors, including RTW Investments.

For more information, please visit www.yarrowbioscience.com.

About VYNE Therapeutics Inc.

VYNE is a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat inflammatory and immune-mediated conditions with high unmet need. VYNE’s unique and proprietary BET inhibitors, which comprise its InhiBET™ platform, are designed to overcome limitations of early generation BET inhibitors by leveraging alternative routes of administration and enhanced selectivity.

For more information, please visit www.vynetherapeutics.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the structure, timing and completion of the proposed Merger; the combined companies’ cash position after closing of the proposed Merger and cash runway of the combined company; the combined company’s listing on Nasdaq after closing of the proposed Merger; expectations regarding the ownership structure of the combined company; the anticipated timing of closing; the expected executive officers of the combined company; the future operations of the combined company; the nature, strategy and focus of the combined company; the development and commercial potential and potential benefits of any product candidates of the combined company; anticipated clinical drug development activities and related timelines, including the expected timing for trial initiation, data and other clinical results; and other statements that are not historical fact. Any forward-looking statements in this release are based on management’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. There can be no assurance that future developments affecting the combined company will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the combined company’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the conditions to the closing of the Merger are not satisfied, including the failure to timely obtain shareholder approval for the transaction, if at all; uncertainties as to the timing of the consummation of the Merger and the ability of each of VYNE and Yarrow to consummate the Merger; risks related to VYNE’s ability to manage its operating expenses and its expenses associated with the Merger pending closing; risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the Merger; the risk that as a result of adjustments to the exchange ratio, VYNE shareholders and Yarrow stockholders could own more or less of the combined company than is currently anticipated; risks related to the market price of VYNE’s common stock relative to the value suggested by the exchange ratio; unexpected costs, charges or expenses resulting from the transaction; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Merger; the uncertainties associated with Yarrow’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks associated with the possible failure to realize certain anticipated benefits of the Merger, including with respect to future financial and operating results; the risk that the related financing is not consummated; and the risk that VYNE’s shareholders receive more or less of the cash dividend than is currently anticipated; and those uncertainties and factors described under the heading “Risk Factors” in VYNE’s Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, and VYNE’s other filings from time to time with the SEC. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. The combined company does not undertake or accept any duty to make any updates or revisions to any forward-looking statements.

NO OFFER OR SOLICITATION

This communication is not intended to and do not constitute (i) a solicitation of a proxy, consent or approval with respect to any securities or in respect of the proposed transaction or (ii) an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended, or an exemption therefrom. Subject to certain exceptions to be approved by the relevant regulators or certain facts to be ascertained, the public offer will not be made directly or indirectly, in or into any jurisdiction where to do so would constitute a violation of the laws of such jurisdiction, or by use of the mails or by any means or instrumentality (including without limitation, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or any facility of a national securities exchange, of any such jurisdiction.

NEITHER THE SEC NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THE SECURITIES OR DETERMINED IF THIS COMMUNICATION IS TRUTHFUL OR COMPLETE

IMPORTANT ADDITIONAL INFORMATION ABOUT THE PROPOSED TRANSACTION WILL BE FILED WITH THE SEC

This communication is not a substitute for any other document that VYNE may file with the SEC in connection with the proposed transaction, including the registration statement on Form S-4 (the “Form S-4”) that will contain a proxy statement and prospectus. In connection with the proposed transaction between VYNE, Yarrow and Merger Sub, VYNE intends to file relevant materials with the SEC, including the Form S-4. VYNE URGES INVESTORS AND STOCKHOLDERS TO READ THE REGISTRATION STATEMENT, INCLUDING THE PROXY STATEMENT/PROSPECTUS CONTAINED THEREIN, AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT VYNE, YARROW, MERGER SUB, THE PROPOSED TRANSACTION AND RELATED MATTERS. Investors and stockholders will be able to obtain free copies of the Form S-4 and other documents filed by VYNE with the SEC (when they become available) through the website maintained by the SEC at www.sec.gov. In addition, investors and stockholders should note that VYNE communicates with investors and the public using its website (www.vynetherapeutics.com) and the investor media website (https://vynetherapeutics.com/investors-media) where anyone will be able to obtain free copies of the Form S-4 and included proxy statement/prospectus and other documents filed by VYNE with the SEC and stockholders are urged to read the Form S-4 and included proxy statement/prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction.

PARTICIPANTS IN THE SOLICITATION

VYNE, Yarrow and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from stockholders in connection with the proposed transaction. Information about VYNE’s directors and executive officers, including a description of their interests in VYNE, is included in VYNE’s most recent definitive proxy statement, as filed with the SEC on November 12, 2025. Additional information regarding these persons and their interests in the proposed transaction will be included in the proxy statement/prospectus relating to the proposed transaction when it is filed with the SEC. These documents can be obtained free of charge from the sources indicated above.

Third-party products and company names mentioned herein may be the trademarks of their respective owners.

Yarrow Media Contact:
Ten Bridge Communications
TBCYarrow@tenbridgecommunications.com

VYNE Investor Relations:
John Fraunces
LifeSci Advisors, LLC
jfraunces@lifesciadvisors.com