Viromed AG: Strategic Update on Operational Focus and Value Creation

Viromed Medical AG

/ Key word(s): Miscellaneous

Viromed AG: Strategic Update on Operational Focus and Value Creation

07.01.2026 / 14:15 CET/CEST

The issuer is solely responsible for the content of this announcement.


PRESS RELEASE

Viromed AG: Strategic Update on Operational Focus and Value Creation

Rellingen, January 7, 2026 – Viromed Medical AG (“Viromed”; ISIN: DE000A3MQR65), a medical technology company and pioneer in cold plasma technology, today provides a strategic update on its operational orientation. The focus of the Company’s entrepreneurial activities remains unchanged and is centered on sustainable, technology-driven growth in the international MedTech market. In this context, Viromed concentrates on the development of innovative medical devices as well as on translational research in the field of severe respiratory diseases — in particular ventilator-associated pneumonia (VAP).

Over the past two years, Viromed has developed two novel cold plasma medical devices:

  • ViroCAP® — an innovative cold plasma device for medical wound healing
  • PulmoPlas® — a globally unique cold plasma system for applications in pneumology and respiratory tract infections

Particular importance is attributed to the next-generation technological platform — PulmoPlas®. This unique cold plasma system forms the basis for future scaling potential across multiple medical indication areas.

In the research domain, Viromed has established a high-performance scientific consortium consisting of Hannover Medical School (MHH), the Helmholtz Centre for Infection Research (HZI) in Braunschweig, and the Leibniz Institute in Jena. This network brings together international top-level expertise in infectiology, pneumology, and translational research and enables the development of novel therapeutic approaches for diseases of the upper and lower respiratory tract.

The comprehensive publication of the results by MHH and HZI is expected at the end of January 2026.

For further technological development, Viromed works closely with Relyon Plasma, a subsidiary of TDK. In addition, international partnerships in Europe, Korea, and Turkey have been established, supporting future market entry and underscoring the global relevance of the technology.

As a result of the strategic focus on research, development, and the establishment of international market structures, longer innovation cycles naturally arise. Viromed therefore deliberately refrains from communicating short-term operational interim updates. Communication with various stakeholders follows the principle of reporting substantial and relevant milestones — in the interest of long-term, sustainable corporate development.

Viromed Medical AG’s corporate strategy is geared toward long-term value generation. Against this backdrop, the Company’s research and development programs are consistently aligned with medical benefit, clinical relevance, and sustainable market potential.

Viromed is recognized as a pioneer in pneumological research and plasma technology. The innovation work of the Company’s scientific network has the potential to significantly shape future therapeutic approaches for severe respiratory infections. According to its own assessment, Viromed will play a significant role in the global fight against pathogenic germs in the coming years — particularly with PulmoPlas®.

In addition, Viromed has successfully overcome the new, stringent regulatory hurdles for the approval of ViroCAP® over the past 18 months. Market acceptance and demand for ViroCAP® are already very high.

About Viromed Medical AG

Viromed Medical AG specializes in the development, manufacture and distribution of medical products. The operating business of the company, which has been listed on the stock exchange since October 2022, focuses on the distribution of innovative cold plasma technology for medical applications via its wholly owned subsidiary Viromed Medical GmbH. Viromed can draw on a broad customer base in the DACH region and beyond. Viromed is pursuing the goal of further advancing the use of cold plasma technology in medicine in the coming years and realizing the corresponding growth potential.

www.viromed-medical-ag.de

Contact Viromed

E-Mail: kontakt@viromed-medical.de
 

Press contact

E-mail: viromed@kirchhoff.de


07.01.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

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Language: English
Company: Viromed Medical AG
Hauptstraße 105
25462 Rellingen
Germany
E-mail: kontakt@viromed-medical.de
Internet: https://www.viromed-medical-ag.de/
ISIN: DE000A3MQR65
WKN: A3MQR6
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt, Hamburg, Tradegate Exchange
EQS News ID: 2256300

 
End of News EQS News Service

2256300  07.01.2026 CET/CEST

Immunic Highlights 2025 Accomplishments and Upcoming Milestones

Issuer: Immunic AG

/ Key word(s): Miscellaneous/Conference

Immunic Highlights 2025 Accomplishments and Upcoming Milestones

07.01.2026 / 12:30 CET/CEST

The issuer is solely responsible for the content of this announcement.


Immunic Highlights 2025 Accomplishments and Upcoming Milestones

– Completed Enrollment for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Top-Line Data Expected by End of 2026 –

– Phase 2 CALLIPER Data Showed Vidofludimus Calcium Reduced 24-Week Confirmed Disability Worsening and Increased 24-Week Confirmed Disability Improvement Across Progressive Multiple Sclerosis and Its Subtypes, Reinforcing the Drug’s Direct Neuroprotective Mechanism of Action –

 – Long-Term Open-Label Data from Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis Showed Low Rates of Confirmed Disability Worsening Events and Favorable Long-Term Safety and Tolerability –

 – U.S. Patent Allowed for Dose Strengths of Vidofludimus Calcium in Progressive Multiple Sclerosis, Strengthening Intellectual Property Protection Into 2041 –

NEW YORK, January 7, 2026 – Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today highlighted its 2025 accomplishments and upcoming milestones.

“The past year has been transformational for our lead asset vidofludimus calcium (IMU-838),” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “We are pleased to have completed enrollment in our twin phase 3 ENSURE-1 and ENSURE-2 trials of vidofludimus calcium in relapsing multiple sclerosis (RMS) and are deeply grateful to the Immunic team, our clinical investigators, site teams, and especially the participants for making this milestone possible. We now eagerly anticipate the synchronized top-line data readout by the end of 2026. The scale, quality, and geographic breadth of the ENSURE trials give us exceptional confidence that the results will provide a clear and comprehensive picture of vidofludimus calcium’s potential to reshape the RMS treatment paradigm. Additionally, long-term open-label extension (OLE) data from the phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis (RRMS) showed that a substantial majority of patients remained free of confirmed disability worsening (CDW) over extended follow-ups, underscoring vidofludimus calcium’s potential to meaningfully slow disease progression, giving patients greater independence and a lower burden in managing symptoms over the long term.”

Jason Tardio, President and Chief Operating Officer of Immunic, added, “The ENSURE program represents more than a pivotal clinical milestone—it reflects an opportunity to advance how disease modification in RMS is approached. Today’s oral RMS treatment landscape is largely defined by therapies with complex risk-benefit profiles that primarily target inflammation and relapses, while often falling short of adequately addressing the neurodegeneration that drives long-term disability. With a dual mechanism of action, vidofludimus calcium is designed to provide direct neuroprotection by enhancing neuronal survival and function through Nurr1 activation, as well as limiting new inflammatory injury through selective DHODH inhibition. Together with its favorable safety and tolerability profile to date, we believe vidofludimus calcium has the potential to offer the most compelling benefit-risk profile among oral disease-modifying therapies for RMS.”

“Equally important are the strong signals we continue to see in progressive multiple sclerosis (PMS) from our phase 2 CALLIPER trial,” continued Dr. Vitt. “In particular, the data has demonstrated clinically meaningful reductions in 24-week CDW (24wCDW) across the overall PMS population, supported by consistent trends across PMS subtypes and subpopulations. Notably, there was no dependency of the 24wCDW effect size on the presence of markers of inflammatory disease at baseline, such as gadolinium-enhancing lesions, supporting our hypothesis of clinical neuroprotective effects independent of anti-inflammatory effects. The positive 24-week confirmed disability improvement (24wCDI) results were statistically significant in the overall PMS population, with consistent trends across subtypes. The findings from our CALLIPER trial reinforce vidofludimus calcium’s unique mechanism of action targeting neurodegeneration and help de-risk potential late-stage development in PMS.”

Dr. Vitt concluded, “As we execute our MS strategy with vidofludimus calcium, we also remain committed to advancing IMU-856, our orally available and systemically acting small molecule modulator that targets Sirtuin 6 (SIRT6), as our next pipeline innovation. IMU-856’s potential ability to restore intestinal barrier function and regenerate bowel epithelium has generated compelling early clinical signals in celiac disease patients, supporting potential development in various gastrointestinal disorders. Additionally, we have seen encouraging preclinical and early clinical effects that may indicate the potential for IMU-856 as an oral treatment option for weight management.”

Vidofludimus Calcium 2025 Highlights and Upcoming Milestones

  • Completed enrollment for both phase 3 ENSURE trials of vidofludimus calcium in patients with RMS. In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 were randomized at more than 100 sites in 15 countries. Top-line data is expected by the end of 2026.
  • Announced positive phase 2 CALLIPER data in PMS, highlighting vidofludimus calcium’s neuroprotective potential across PMS as well as PMS subpopulations and subtypes. The data, showing consistent 24wCDW results across patient groups, including those without evidence of baseline inflammatory gadolinium-enhancing (Gd+) lesions, were seen in the overall population and in the key primary progressive multiple sclerosis (PPMS) and non-active secondary progressive multiple sclerosis (naSPMS) subgroups. 24wCDI data demonstrated more than a two-fold probability of clinical improvement versus placebo, achieving statistical significance in the overall PMS population with consistent trends across subtypes. Vidofludimus calcium also lowered thalamic atrophy and new or enlarging T2 lesion volume versus placebo. No new safety signals were observed and vidofludimus calcium continued to show a favorable safety and tolerability profile. Given that 24wCDW is an accepted regulatory endpoint in PMS, these results strengthen the evidence of clinical activity and should help to de-risk a potential phase 3 program.
  • Reported new, positive long-term OLE data from the phase 2 EMPhASIS trial of vidofludimus calcium in patients with RRMS. At week 144, 92.3% of patients remained free of 12wCDW with 92.7% remaining free of 24wCDW. Vidofludimus calcium continued to demonstrate a favorable safety and tolerability profile with long-term data available up to 5.5 years.
  • Received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent covering dose strengths of vidofludimus calcium for the treatment of PMS, including PPMS and SPMS. The company’s multilayered intellectual property strategy now provides protection into 2041 in the United States, unless extended further.
  • Presented key data highlighting vidofludimus calcium’s therapeutic potential in MS at various scientific and medical conferences, including the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), the 17th International Congress of the International Society of Neuroimmunology (ISNI), the 11th Congress of the European Academy of Neurology (EAN) – Helsinki 2025, the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting 2025, the American Academy of Neurology (AAN) 2025 Annual Meeting and the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025. The results from the phase 2 CALLIPER trial in PMS were also selected for the Best of ECTRIMS 2025 slide deck.

IMU-856 2025 Highlights and Upcoming Milestones

  • Announced that IMU-856 demonstrated a dose-dependent increase of endogenous glucagon-like peptide-1 (GLP-1) levels in a post hoc analysis of patients from the phase 1b clinical trial in celiac disease. IMU-856 also showed a dose-dependent reduction of body weight gain and food consumption in preclinical in vivo testing. These effects may indicate the potential for IMU-856 as an oral treatment option for weight management.
  • Presented further analyses from the phase 1/1b clinical trial of IMU-856 in healthy subjects and celiac disease patients at several key gastroenterology conferences, including at UEGW 2025 – United European Gastroenterology Week, Digestive Disease Week (DDW) and the 19th Congress of ECCO (European Crohn’s and Colitis Organisation).
  • The company continues preparing for further clinical testing of IMU-856, contingent on financing, licensing or partnering.

2025 Corporate Highlights

  • Closed a $5.1 million registered direct offering led by Aberdeen Investments.
  • Closed an oversubscribed $65 million underwritten public offering, co-led by BVF Partners and Coastlands Capital, and including participation from Aberdeen Investments, Adage Capital Partners LP, Janus Henderson Investors, and other institutional investors.

Immunic’s management, business development and investor relations teams will be hosting one-on-one meetings in connection with the 44th Annual J.P. Morgan Healthcare Conference taking place January 12-15, 2026, in San Francisco. To schedule a meeting, please contact Jessica Breu at: jessica.breu@imux.com.

About Immunic, Inc.

Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. The company’s lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic’s development programs and the targeted diseases; the potential for Immunic’s development programs to safely and effectively target diseases; preclinical and clinical data for Immunic’s development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; the executive and board structure of the company; and the company’s expected cash runway. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company’s products or product candidates, the protection and market exclusivity provided by Immunic’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned “Risk Factors,” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025, and in the company’s subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.

Contact Information 

Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com

US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com 

US Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com


Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Vaxxas Appoints Former Merck Global Vaccines President David Peacock as CEO

Vaxxas Appoints Former Merck Global Vaccines President David Peacock as CEO




Vaxxas Appoints Former Merck Global Vaccines President David Peacock as CEO

BRISBANE, Australia and CAMBRIDGE, Mass., Jan. 07, 2026 (GLOBE NEWSWIRE) — Vaxxas Pty Ltd today announced the appointment of global biopharmaceutical executive Mr David Peacock as Chief Executive Officer to lead the commercialisation of the Company’s proprietary high‑density microarray patch (HD‑MAP) vaccination technology.

Mr Peacock brings more than 25 years of global vaccine and pharmaceutical leadership, most recently in roles as President of Merck Global Vaccines, and President of MSD Asia Pacific.

His career spans senior commercial, operational, and financial positions across Japan, the United States, Europe, and Asia, and includes service on boards and industry bodies such as the US‑ASEAN Business Council, the Association of the British Pharmaceutical Industry, and Gavi, the Vaccine Alliance.

Throughout his career Mr Peacock has demonstrated strong entrepreneurial and innovation success through start-ups, digital commercial innovation and funding access initiatives.

Vaxxas Chair, Ms Sarah Meibusch said Mr Peacock’s appointment aligns with the company’s near‑term pathway to market and growth strategy.

“David’s appointment marks a clear inflection point for Vaxxas as we move from clinical validation towards commercial execution. He brings unmatched global vaccine commercialisation experience at precisely the moment the HD-MAP technology is transitioning from proof-of-concept to a scalable delivery platform with the potential to materially improve how vaccines are manufactured, distributed and administered worldwide.

“For global pharmaceutical partners, the HD-MAP offers a differentiated self-delivery administration option to enhance existing vaccine franchises, extend lifecycle value and address persistent challenges around cold-chain, dose efficiency and access. David’s leadership positions Vaxxas to engage at scale with governments and multinational vaccine companies as a long-term strategic partner,” said Ms Meibusch.

Mr Peacock said he is energised by the potential of Vaxxas’ HD‑MAP technology to reshape vaccine delivery and access.

“Over the course of my career, I have seen first-hand the limitations of conventional vaccine delivery technologies in both developed, and developing, healthcare systems. I believe Vaxxas’ HD-MAP technology has the potential to fundamentally reshape vaccine access, distribution, and administration.

“Vaxxas is now at a pivotal stage, with clinical validation, licensed manufacturing capability and a platform that can integrate with existing and future vaccine programs. I am excited to lead the company as we partner with pharmaceutical companies, research organisations and governments to translate this technology for global public-health and commercial impact,” said Mr Peacock.

Mr Peacock will also be appointed as Executive Director to the Vaxxas board.

Building Momentum Toward Market

Vaxxas recently secured a manufacturing licence from the Therapeutic Goods Administration (TGA), for HD‑MAP vaccine products at the company’s Brisbane biomedical facility, a significant regulatory milestone that materially de-risks the path to commercial supply. The licence follows the installation of Vaxxas’ first robotic lines for aseptic (sterile) manufacture, enabling scalable, GMP-compliant production to support clinical and future commercial programs.

Mr Peacock’s appointment also follows recent board and leadership additions, most notably global vaccine industry veteran Brent MacGregor, CEO of Medical Developments International (ASX: MVP), who has more than 30 years of senior commercial leadership across the global vaccines sector. Mr MacGregor has held leadership roles at CSL Seqirus, Novartis Vaccines and Sanofi Pasteur across North America, Europe and Asia, and brings deep experience in vaccine commercialisation and scale. He is complemented by Michael Shleifer, Co-Founder and Managing Partner of SPRIM Global Investments, which anchored Vaxxas’ approximately $90 million financing this year, joining as Board Observer.

“Together, these appointments provide Vaxxas significant depth in global vaccine commercialisation, manufacturing and partnership expertise. This strengthens Vaxxas’ ability to work credibly with multinational pharmaceutical companies and governments as the HD-MAP technology advances toward scaled manufacture and broader deployment,” Ms Meibusch added.

About Vaxxas
Vaxxas is a biotechnology company pioneering HD-MAP technology for future self-administered vaccine delivery. The HD-MAP has been administered to more than 750 participants across clinical trials, demonstrating strong safety, tolerability, and robust immune responses. Preclinical and clinical data indicate the technology has the potential to deliver all major vaccine types positioning HD-MAP as a universal delivery solution. By targeting immune cells just beneath the skin, the HD-MAP has the potential to achieve stronger protection with smaller doses, while reducing cold-chain requirements and enabling self-administration.

Vaxxas’ programs are advancing toward commercialisation with support from global partners including SK bioscience, the US Government, the Wellcome Trust, and the Gates Foundation, assessing the potential of HD‑MAP to vaccinate against COVID‑19, seasonal and pre‑pandemic influenza, and measles and rubella. The company recently installed robotic lines for aseptic (sterile) manufacture at its state‑of‑the‑art Brisbane biomedical facility supporting scalable, GMP-compliant production for clinical and future commercial supply.

Investigational Use Notice
HD‑MAP‑delivered vaccines are under investigation and are not approved for sale or purchase anywhere in the world. Vaxxas makes no claims regarding reliability, durability, dependability, safety, efficacy, or superiority to any other vaccine or vaccine delivery technology.

A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/6b1ec1d5-e7a0-42cd-a707-66acc4905ff5
https://www.globenewswire.com/NewsRoom/AttachmentNg/1b38e870-00e0-4868-bc1b-05f0f5f868c8
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CONTACT: Media Contact
Helen Wallace
We. Communications
+61 310 710 305
hwallace@wecommunications.com

Verrica Pharmaceuticals Announces First Patient Dosed in Phase 3 Program Evaluating YCANTH® (VP-102) for the Treatment of Common Warts

Verrica Pharmaceuticals Announces First Patient Dosed in Phase 3 Program Evaluating YCANTH® (VP-102) for the Treatment of Common Warts




Verrica Pharmaceuticals Announces First Patient Dosed in Phase 3 Program Evaluating YCANTH® (VP-102) for the Treatment of Common Warts

– Common warts affects approximately 22 million patients in the United States alone, and there are no FDA approved prescription therapies for what is believed to be a multibillion-dollar market opportunity–

– Verrica has global rights to YCANTH for all indications in all territories outside of Japan –

WEST CHESTER, Pa., Jan. 07, 2026 (GLOBE NEWSWIRE) — Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing and selling medications for skin diseases requiring medical interventions, today announced that the first patient was dosed in December 2025 in the global Phase 3 program evaluating YCANTH (VP-102) for the treatment of common warts.

“The dosing of the first patient in the global Phase 3 program in common warts represents an important clinical milestone for our label expansion strategy of YCANTH,” said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. “The clinically meaningful activity observed for the primary endpoint of complete clearance in the Phase 2 COVE-1 study provides strong evidence that YCANTH has the potential to become the first therapy ever approved in both the United States and Japan for the treatment of common warts – a condition that impacts over 22 million people in the U.S. alone. Having retained full commercial rights for all potential YCANTH indications outside of Japan, common warts represents a substantial commercial and licensing opportunity for our company. Coupled with our recently completed $50 million financing and repayment of our debt facility with OrbiMed, this significant clinical milestone is another key step towards the expansion of the YCANTH franchise and the future growth of Verrica.”

COVE-1 Phase 2 Data and Phase 3 Program in Common Warts

The initiation of the global Phase 3 program in common warts is based upon positive results from the Phase 2 COVE-1 clinical trial that evaluated YCANTH (VP-102) for the treatment of common warts. COVE-1 was an open label clinical trial that evaluated the safety and efficacy of VP-102 in two cohorts of subjects with up to six warts. The primary efficacy analysis was conducted at Day 84 with an additional period of follow-up through Day 147. Topline analysis included data from the assessment of warts at study visits over 12 weeks. Results showed that 51% of subjects (18 of 35) treated with VP-102 in Cohort 2 achieved complete clearance of all treatable warts at Day 84. Adverse events were primarily expected local cutaneous reactions with no SAEs observed. Torii will split the costs of the global Phase 3 program with Verrica on a 50/50 basis and will fund the first $40 million of trial costs, representing approximately 90% of the current trial budget, with Verrica’s portion expected to be paid out of future milestones/royalties for YCANTH in Japan.

Market Opportunity in Common Warts

With a prevalence of approximately 22 million patients in the U.S. alone and no FDA approved therapies, common warts represent one of the largest unmet needs in all of dermatology, which Verrica believes could represent a multibillion-dollar commercial opportunity. In the United States, approximately 50% of the patients who seek treatment for common warts are children. If YCANTH is successfully developed, approved and commercialized for the treatment of common warts, Verrica anticipates a high degree of call point overlap and marketing synergies with its promotion of YCANTH for the treatment of molluscum. Verrica further believes that the common wart patient opportunity in the European Union is comparable to that in the United States.

About YCANTH® (VP-102)
YCANTH® is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical dosing and targeted administration for the treatment of molluscum. YCANTH is the first and only healthcare professional-administered product approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. Approval of YCANTH was based upon the positive results from two Phase 3 clinical trials in approximately 500 patients which demonstrated that YCANTH was a safe and effective therapeutic for the treatment of molluscum. Approximately 250 million lives are eligible to receive YCANTH covered by insurance. Commercially insured patients pay just $25 per YCANTH treatment visit, for up to two applicators. Other uninsured patients may be eligible to receive YCANTH at a reduced cost if certain eligibility requirements are met for patient assistance. Please visit YCANTHPro.com for additional information.

About Verrica Pharmaceuticals Inc.
Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s product YCANTH® (VP-102) (cantharidin), is the first and only healthcare professional-administered treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH® (VP-102) is also in development to treat common warts, the largest remaining unmet need in medical dermatology. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 (ruxotemitide, formerly known as LTX-315 and VP-LTX-315) for non-melanoma skin cancers including basal cell carcinoma and squamous cell carcinoma.

Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include statements about the commercialization of YCANTH, clinical development, clinical timelines and potential benefits of YCANTH for the treatment of common warts, These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include risks and uncertainties related to market conditions, satisfaction of customary closing conditions related to the proposed public offering and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2024, Verrica’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 and other filings Verrica makes with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

FOR MORE INFORMATION, PLEASE CONTACT:

Investors:

John Kirby
Interim Chief Financial Officer
jkirby@verrica.com

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

SAB BIO Strengthens Board of Directors with Appointment of New Chair and New Director

SAB BIO Strengthens Board of Directors with Appointment of New Chair and New Director




SAB BIO Strengthens Board of Directors with Appointment of New Chair and New Director

David Zaccardelli, Pharm.D. joins Board as Chair

Rita Jain, M.D., joins Board as an Independent Director

MIAMI, Jan. 07, 2026 (GLOBE NEWSWIRE) — SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company developing a fully human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other autoimmune diseases, today announced the appointment of David Zaccardelli, Pharm.D. to its Board of Directors as Chair of the Board and the appointment of Rita Jain, M.D., as an independent director, both effective immediately.

“We are excited to welcome Dr. David Zaccardelli and Dr. Rita Jain to our Board of Directors. I, along with the rest of our Board, am confident that David and Rita will make a significant impact on SAB BIO,” said Samuel J. Reich, CEO, SAB BIO.

Mr. Reich continued, “David is an esteemed biotech executive with a proven track record of growing companies and creating shareholder value, including leading the recent launch of Ohtuvayre®, which ranks among one of the most successful biotech product launches in the last decade. His appointment as Chair of the Board underscores SAB’s growth trajectory, validates our strategic direction, and reinforces confidence in our near- and long-term potential. Rita is a recognized expert in autoimmune and inflammatory disease drug development with deep experience in advancing innovative drugs through clinical development. Collectively, David and Rita bring highly complementary expertise that will be invaluable as we continue to execute clinically and advance a potentially transformative, disease-modifying therapy for patients with autoimmune T1D.”

Dr. David Zaccardelli is an accomplished biopharmaceutical executive with more than 20 years of experience leading companies through transformational growth, including leading organizations from clinical stage to commercialization.

“I am pleased to join SAB BIO as Chair of the Board at this pivotal time for the Company. SAB-142 is a potential game changer for people living with T1D and an extraordinary opportunity to fundamentally change the treatment paradigm for T1D. I look forward to partnering with the Board and management to help guide the Company at this important juncture through clinical development and preparation for potential commercialization,” said Dr. Zaccardelli.

Dr. Rita Jain is a rheumatologist who brings more than two decades of leadership experience in biopharmaceutical development, clinical strategy, and regulatory affairs across multiple therapeutic areas, including immunology, inflammation, nephrology, and rare diseases.

“SAB BIO is at the forefront of developing a therapy that may dramatically transform the treatment of Type 1 Diabetes, and, in the future, the lives of people living with other autoimmune diseases. I am excited to join the Board of Directors and partner with the Company as they advance SAB-142 through a registrational clinical trial,” said Dr. Jain.

About David Zaccardelli, Pharm.D.
Dr. David Zaccardelli is an accomplished biopharmaceutical executive with more than 20 years of experience leading companies through transformational growth, including leading companies from clinical to commercial stage. He most recently served as President and Chief Executive Officer of Verona Pharma until its acquisition by Merck & Co., Inc. Under his leadership, the Company successfully completed two Phase 3 trials, received its first FDA approval, and launched Ohtuvayre® (ensifentrine). During his tenure, Dr. Zaccardelli was recognized as Executive of the Year at Scrip’s 2023 Awards. Prior to Verona Pharma, Dr. Zaccardelli served as President and CEO of Dova Pharmaceuticals, a U.S. company developing therapeutics for rare diseases, from December 2018 until its acquisition by Swedish Orphan Biovitrum in November 2019. Previously, he was Acting CEO of Cempra, from 2016 until the company’s merger with Melinta Therapeutics in 2017. From 2004 until 2016, Dr. Zaccardelli served in several senior management roles at United Therapeutics Corporation, including Chief Operating Officer, Chief Manufacturing Officer, and Executive Vice President, Pharmaceutical Development and Operations. Prior to United Therapeutics, he founded and led a start-up company focused on contract research and held a variety of clinical research positions at Burroughs Wellcome & Co, Glaxo Wellcome, and Bausch & Lomb Pharmaceutical. Dr. Zaccardelli received a Pharm.D. from the University of Michigan and completed a fellowship in clinical research and drug development at the University of North Carolina.

About Rita Jain, M.D.
Dr. Rita Jain is a rheumatologist who brings more than two decades of leadership experience in biopharmaceutical development, clinical strategy, and regulatory affairs across multiple therapeutic areas, including immunology, inflammation, nephrology, and rare diseases. She most recently served as Executive Vice President and Chief Medical Officer at ChemoCentryx, where she advanced development and supported commercialization of Tavneos® (avacopan), a first-in-class treatment for ANCA-associated vasculitis, and supported the company’s acquisition by Amgen in 2022. Prior to that, she was Senior Vice President and Chief Medical Officer at Akebia Therapeutics. Additionally, Dr. Jain held key leadership positions at AbbVie, Abbott Laboratories, Pfizer, and Immunovant, overseeing global development programs, regulatory interactions, and clinical operations for multiple therapeutic candidates. She also serves on the boards of Celldex Therapeutics, AnaptysBio, and Avalo Therapeutics. She previously served on the board of directors of Provention Bio, Inc., until its acquisition by Sanofi; ChemoCentryx, Inc., until its acquisition by Amgen; and AM Pharma. Dr. Jain received her M.D. from the State University of New York at Stony Brook School of Medicine and completed her residency in internal medicine at Staten Island University Hospital, followed by a fellowship in rheumatology at North Shore University Hospital and a Clinical Research Fellowship at the University of Texas Southwestern Medical Center, Dallas.

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

4DMT Provides Company Update and Anticipated Development Milestones for 2026

4DMT Provides Company Update and Anticipated Development Milestones for 2026




4DMT Provides Company Update and Anticipated Development Milestones for 2026

  • Enrollment in 4D-150 Phase 3 wet AMD clinical trials exceeding expectations; 4FRONT-1 trial remains on track to complete enrollment in Q1 2026, with 381 patients randomized or approved to randomize as of January 6, 2026
  • 4D-150 PRISM wet AMD 2-year Phase 2b data expected mid-2026
  • 4D-150 DME global Phase 3 trial initiation expected Q3 2026; 2-year SPECTRA Phase 1/2 data expected H2 2026
  • Appointed Glenn Sblendorio to Board of Directors, adding deep commercial and operating experience, including in retina therapeutics
  • Company to present strategic outlook at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, at 7:30am PT

EMERYVILLE, Calif., Jan. 07, 2026 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today provided a corporate update and outlook for 2026.

Expected Milestones for 4D-150 in Retinal Vascular Disease

  • 4D-150 for Wet Age-related Macular Degeneration:  
    • 4FRONT Global Phase 3 Program:
      • To further the potential for global regulatory success, target enrollment was increased from 400 to 480 patients per trial
        • Provides approximately 90% power with a noninferiority margin of 4 letters as aligned with the Japan Pharmaceuticals and Medical Devices Agency and European Medicines Agency
      • 4FRONT-1, North American Clinical Trial: 
        • 381 patients randomized or approved to randomize as of January 6, 2026; enrollment remains on track to be completed in Q1 2026, with topline data expected in H1 2027 
      • 4FRONT-2, Global Clinical Trial:
        • Ex-U.S. site activation and patient screening accelerating across Europe and Asia-Pacific; enrollment remains on track to be completed in H2 2026, with topline data expected in H2 2027
    • PRISM Phase 1/2 Clinical Trial:
        • 2-year Phase 2b data in a broad patient population, including the recently diagnosed subgroup population most comparable to the 4FRONT Phase 3 population, expected to be presented at a scientific conference in mid-2026
  • 4D-150 for Diabetic Macular Edema:  
    • 2-year SPECTRA Phase 1/2 clinical trial data expected H2 2026
    • Phase 3 trial design expected mid-2026
    • Global Phase 3 trial initiation expected in H2 2026

Leadership Evolution to Support Late-Stage Execution and Commercial Readiness

  • Glenn P. Sblendorio joined the 4DMT Board of Directors and will serve on the Compensation and Science & Technology committees. Mr. Sblendorio most recently served as President and Chief Executive Officer of IVERIC Bio through its acquisition by Astellas Pharma in July 2023. Prior to IVERIC Bio, Mr. Sblendorio was President and Chief Financial Officer of The Medicines Company, and previously held senior executive roles at Eyetech Pharmaceuticals. Mr. Sblendorio currently serves as a member of the Board of Directors of Amicus Therapeutics (to be acquired by BioMarin), as Chair of the Board of Directors of Mineralys Therapeutics, and previously served as a member of the Board of Directors of Intercept Pharmaceuticals.
  • Katy Barglow, Ph.D., was promoted to Chief Technical Officer. Since joining 4DMT in 2017, Dr. Barglow has built and scaled the company’s AAV manufacturing and analytical capabilities, including in her previous role as Senior Vice President. As CTO, Dr. Barglow will continue to oversee 4DMT’s transition to commercial manufacturing, with responsibility for CMC quality, supply chain, and technical operations.
  • Kim Maplestone was promoted to Chief Clinical Operations Officer. Since joining 4DMT in 2019, Ms. Maplestone has played a central role in advancing the Company’s clinical programs. In her new role, Ms. Maplestone will continue to oversee global clinical operations across the Company’s portfolio, with responsibility for delivering inspection-ready, high-quality data to support regulatory submissions.
  • Chris Simms’ role expanded to Chief Commercial & Business Officer. Mr. Simms’ responsibilities have expanded to include oversight and management of business development, in addition to his existing commercial leadership.
  • Fred Kamal, Ph.D., has transitioned from his role as President and Chief Operating Officer to Chief Technical Advisor as a part-time employee, effective January 1, 2026, supporting CMC and regulatory strategy for 4D-150. With this transition, David Kirn, M.D., has assumed the role of President in addition to Chief Executive Officer.

“We look forward to continuing our disciplined execution and organizational readiness to potentially commercialize 4D-150 for retinal vascular diseases,” said David Kirn, M.D., Co-founder, President and Chief Executive Officer of 4DMT. “The continued progress in our late-stage development of 4D-150, the evolution of our leadership team and the addition of Glenn Sblendorio to our Board reflects our focus on transitioning to becoming a commercial large market retina therapeutics company. With a strong leadership team and the support of our Asia-Pacific partner Otsuka, we believe 4DMT is well positioned to transform the treatment of retinal vascular diseases, including wet AMD and DME, with 4D-150 globally.”

Other Pipeline Programs

  • 4D-175 in Geographic Atrophy: Additional clinical development pending financing, including potential partnerships
  • 4D-710 in Cystic Fibrosis Lung Disease: Phase 2 ongoing, fully funded by the Cystic Fibrosis Foundation, with program update expected in H2 2026
  • 4D-725 in A1AT Lung Disease: Preclinical development ongoing, fully funded by the California Institute for Regenerative Medicine

Financial Position

As of December 31, 2025, Company had $514 million in cash, cash equivalents and marketable securities (unaudited), which is expected to fund currently planned operations into the second half of 2028.

44th Annual J.P. Morgan Healthcare Conference

Presentation Date: Wednesday, Jan. 14, 2026
Presentation Time: 7:30 a.m. PT
Webcast Link: Webcast
   

An archived copy of the webcast will be available for up to one year on the “Investors” section of the 4DMT website at https://ir.4dmoleculartherapeutics.com/events.

About 4DMT  

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients with retina diseases. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and the second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT.  

All of the Company’s product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of the Company’s product candidates for the therapeutic uses for which they are being studied. 

Learn more at www.4DMT.com and follow us on LinkedIn

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential and clinical benefits of, as well as the plans, announcements and related timing for the clinical development of, our product candidates, our financial performance, results of operations and anticipated cash runway, expectations regarding the performance and success of our leadership team and recent leadership transitions, and our ongoing collaboration with Cystic Fibrosis Foundation. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target,” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including: (i) risks that clinical trial results may not support regulatory approval or demonstrate sustained therapeutic benefit; (ii) risks that our product candidates may not demonstrate sufficient safety or efficacy; (iii) risks related to regulatory approval processes and evolving standards for gene therapies; (iv) risks that 4D Molecular Therapeutics may not receive necessary funding or may require additional capital for its operations and anticipated commercialization; (v) risks related to manufacturing complexity and supply chain for gene therapies; and (vi) risks of competition and rapidly evolving treatment landscape; as well as other risks and uncertainties that are described in greater detail in the section entitled “Risk Factors” in 4D Molecular Therapeutics’ most recent Quarterly Report on Form 10-Q filed on November 10, 2025, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statement represents 4D Molecular Therapeutics’ views only as of today and should not be relied upon as representing its views as of any subsequent date. 4D Molecular Therapeutics undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release, except as may be required by law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. 

Contacts:

Media:
Jenn Gordon
dna Communications
Media@4DMT.com

Investors:
Julian Pei
Head of Investor Relations and Strategic Finance
Investor.Relations@4DMT.com

Egle Therapeutics Appoints John Celebi as Chief Executive Officer

Egle Therapeutics Appoints John Celebi as Chief Executive Officer




Egle Therapeutics Appoints John Celebi as Chief Executive Officer

PARIS, Jan. 07, 2026 (GLOBE NEWSWIRE) — Egle Therapeutics SAS (Egle), a clinical-stage biotechnology company pioneering precision medicines that modulate regulatory T cells (Tregs) to rebalance immune function in patients with autoimmune diseases and cancer, today announced the appointment of John Celebi, M.B.A., as chief executive officer. Mr. Celebi is a seasoned biotechnology executive with over 30 years of experience building and scaling innovative life sciences companies and has been a member of the Egle board of directors since 2024.

Mr. Celebi’s appointment comes as Egle enhances its clinical development focus on autoimmune diseases, where recent validation of the IL-2 mechanism has created a significant opportunity for differentiated therapies in major indications. The company’s lead programs are novel IL-2 receptor alpha-biased muteins designed with best-in-class selectivity for regulatory T cells, offering the potential for deeper efficacy, improved safety, and sustained immune rebalancing without Treg exhaustion.

“As Egle deepens its focus on autoimmune diseases, the appointment of John represents a strategic and thoughtful evolution of our leadership team,” said Michel Detheux, Ph.D., Chair of the Board of Egle Therapeutics. “John is an accomplished leader whose service on Egle’s board brings valuable continuity to our vision and disciplined execution. His proven track record in building biotechnology companies from early stages through successful public market offerings, combined with his expertise in strategic partnerships and therapeutics development, positions Egle to capitalize on the significant opportunity in Treg biology. We are confident his leadership will accelerate our mission to deliver transformative therapies for patients.”

John Celebi brings extensive senior operating and business leadership experience, spanning corporate strategy, business development and therapeutic R&D. He joins Egle from Sensei Bio (NASDAQ: SNSE) where he served as chief executive officer during key stages of growth, including closing a successful $152 million initial public offering, raising over $220 million in total equity capital and establishing a clinical-stage pipeline. Prior to that, he led business development at ArQule, where he negotiated over $1.5 billion in strategic alliances with global pharmaceutical partners including Roche, Daiichi-Sankyo, and Kyowa Hakko Kirin, and served as chief business officer at Igenica Biotherapeutics, where he closed a Series C financing and established a strategic collaboration with AstraZeneca. Mr. Celebi holds an M.B.A. from Carnegie Mellon University and a B.S. in Biophysics from the University of California, San Diego.

“I am honored to expand my role at Egle as chief executive officer and build on the strong foundation already in place,” said Mr. Celebi. “The recent clinical validation of IL-2-based therapies in autoimmune diseases, combined with the differentiated profiles of Egle’s best-in-class Treg modulators, creates a compelling opportunity to bring meaningful therapies to patients. With our healthy volunteer single ascending dose data anticipated in the first half of 2026, I am excited to leverage my experience in drug development and strategic partnerships to advance Egle’s innovative science toward patients living with autoimmune diseases. I look forward to working with the board and the entire team to translate Egle’s opportunity into significant value for patients and our key stakeholders.”

About Egle Therapeutics
Egle Therapeutics is a clinical-stage biotechnology company pioneering precision medicines that modulate regulatory T cells (Tregs) to rebalance immune function in patients with autoimmune diseases and cancer. The company’s proprietary technology platform enables the engineering of highly selective IL-2 variant immuno-conjugates which are designed to overcome the efficacy and safety limitations of previous Treg-focused therapies. Its autoimmunity portfolio is led by EGL-003, an IL-2 agonist Treg engager currently being explored as a potential treatment for atopic dermatitis and other autoimmune diseases. Egle’s immuno-oncology portfolio includes EGL-001, an anti-CTLA-4-IL-2m fusion which has implemented its first-in-human dosing, and EGL-002, an anti-CCR8 x anti-CD25 bispecific. For more information, visit www.egle-tx.com and follow us on LinkedIn.

Contacts
contact@egle-tx.com / 0033 (0)1 86 64 08 57
investor.relations@egle-tx.com / 0033 (0)1 86 64 08

Stallergenes Greer Expands Venom Immunotherapy Production Capacity With Acquisition of Entomon s.r.l.

Stallergenes Greer Expands Venom Immunotherapy Production Capacity With Acquisition of Entomon s.r.l.




Stallergenes Greer Expands Venom Immunotherapy Production Capacity With Acquisition of Entomon s.r.l.

BAAR, Switzerland–(BUSINESS WIRE)–Stallergenes Greer, a global leader in allergy therapeutics, today announced that it has entered into an agreement to acquire Entomon s.r.l., an Italian company specialising in the production of certified stinging-insect venom extracts, notably of the Hymenoptera order, used for the manufacture of diagnostic preparations and Venom Immunotherapy (VIT). The transaction is expected to close by the end of January.


Entomon, currently recognised as the only company in Europe capable of extracting pure venom from Hymenoptera insects, produces pharmaceutical-grade insect venom using proprietary techniques (Entomon Capillary Extracted Venom®) for medical use.

Through this acquisition, Stallergenes Greer bolsters its venom manufacturing capabilities and supply of raw materials for life-saving VIT treatments, whilst safeguarding patient care continuity.

Hymenoptera venom allergy is the most common trigger of severe anaphylaxis in adults1. According to the EAACI guidelines on venom immunotherapy, VIT is the only treatment that can prevent systemic inflammatory reactions to bee or wasp stings and significantly improve quality of life, even for people with less severe allergic reactions.2

Entomon’s activities complement Stallergenes Greer’s portfolio and strengthen our control of critical allergen extracts, notably Hymenoptera venoms used in allergen immunotherapy” stated Dr. Andreas Amrein, Chairman and CEO of Stallergenes Greer. “This acquisition secures long-term access to high-quality venom extracts in a market constrained by limited global capacity. It also builds on our existing partnerships and supports a diversified model for venom immunotherapy components. By reinforcing supply chain diversification and building on our well-established position in venom immunotherapy with Albey®, we strengthen our ability to support patients and healthcare professionals worldwide and deliver on our long-term commitment to high-standard, reliable allergy care. We are delighted to welcome Entomon to the Stallergenes Greer Group.”

Becoming part of Stallergenes Greer marks a transformative moment for Entomon. It is a testament to our expertise in the extraction of pure Hymenoptera venom and our ability to deliver high-quality raw materials which are essential for life-saving allergen immunotherapies. We are excited to embark on this new chapter,” declared Dr. Elisabetta Francescato, CEO and founder of Entomon s.r.l.

About hymenoptera venom allergies

Stinging-insect venom sensitisation is common in the general population (between 9.3% and 28.7%), and more than half of the population will be stung by an insect at least once in their lifetime depending on the living environment and type of activity.3 4

Venom allergy is an IgE-mediated hypersensitivity reaction triggered by stings from insects such as bees, wasps, hornets, or other Hymenoptera species. While local reactions are common and usually mild, venom-allergic individuals can experience systemic responses ranging from widespread hives to severe anaphylaxis. Hymenoptera venom allergy is the primary cause of anaphylaxis in adults in Europe, being responsible for 48.2% of cases and 20.2% in children worldwide5. Based on national mortality surveillance, fatal anaphylaxis due to Hymenoptera stings accounts for approximately 72 deaths per year in the United States6, while European data indicate a comparable burden of about 73 deaths annually across 32 countries7.

Diagnosis relies on a combination of clinical history, skin testing, and specific IgE measurement to identify the responsible insect. Venom immunotherapy is the only treatment proven to modify the natural course of venom allergy. It provides long-term protection by inducing immune tolerance8, markedly reducing the risk of systemic reactions to future stings and improving patients’ quality of life.

Because Hymenoptera venoms differ by species, the availability and quality of venom extracts are essential to enable accurate diagnosis and effective immunotherapy, ensuring patients receive targeted and reliable treatment.

About Albey® Venoms

Albey® Venoms are standardised purified extracts derived from hymenoptera species, including honeybee (Apis mellifera), yellow jacket (Vespula spp.), and paper wasp (Polistes spp.). These extracts are specifically designed for Venom Immunotherapy (VIT), the only proven treatment to prevent severe systemic allergic reactions.

Albey® holds marketing authorisations in France, Italy, Australia and New Zealand. It is also available in Italy under ope legis status.

About Entomon

Based in Florence (Italy), Entomon s.r.l. is a privately held company established by leading biologists and naturalists with deep expertise in the study of insects and their impact on human health and activity. The company specialises in the extraction of pure insect venom extracts for diagnostic reagents and venom immunotherapy for individuals with insect sting allergies. Entomon is the sole producer in Europe of insect of pure, certified Hymenoptera venom extracts. For more information, please visit: www.entomon.it

About Stallergenes Greer

Headquartered in Baar (Switzerland), Stallergenes Greer is a global healthcare company specialising in the diagnosis and treatment of allergies through the development and commercialisation of allergen immunotherapy products and services. Supported by more than 100 years of expertise and innovation, our products are available for patients in over 40 countries. For more information, please visit www.stallergenesgreer.com.

1 Hymenoptera (bee and wasp) Stevens et al. Recent insights into the mechanisms of anaphylaxis. Curr Opin Immunol. 2023 Apr;81

2 EAACI guidelines on allergen immunotherapy: Hymenoptera venom allergy (Allergy. 2018 Apr;73(4):744-764)

3 Bilò, M. B., Pravettoni, V., Bignardi, D., Bonadonna, P., Mauro, M., Novembre, E., … & Pastorello, E. A. (2019). Hymenoptera venom allergy: management of children and adults in clinical practice. Journal of investigational allergology & clinical immunology, 29(3), 180-205.

4 Golden, D. B., Demain, J., Freeman, T., Graft, D., Tankersley, M., Tracy, J., … & Wallace, D. (2017). Stinging insect hypersensitivity: a practice parameter update 2016. Annals of Allergy, Asthma & Immunology, 118(1), 28-5

5 Rueff et al., (2023) Diagnosis and treatment of Hymenoptera venom allergy

6 QuickStats: Number of Deaths from Hornet, Wasp, and Bee Stings Among Males and Females — National Vital Statistics System, United States, 2011–2021. MMWR Morb Mortal Wkly Rep 2023;72:756.

7 Feás, X.; Vidal, C.; Remesar, S. What We Know about Sting-Related Deaths? Human Fatalities Caused by Hornet, Wasp and Bee Stings in Europe (1994–2016). Biology 2022, 11, 282. https://doi.org/10.3390/biology11020282
8 Golden et al. J Allergy Clin Immunol. 2011 Apr ;127(4):852-4.e1-23

Contacts

Stallergenes Greer
Communications

Catherine Kress

Tel: +33 (0)1 55 50 26 05

Email: catherine.kress@stallergenesgreer.com

World-renowned Immunologist and Distinguished Scientist Joins CancerVax as Senior Scientific Advisor

World-renowned Immunologist and Distinguished Scientist Joins CancerVax as Senior Scientific Advisor




World-renowned Immunologist and Distinguished Scientist Joins CancerVax as Senior Scientific Advisor

Dr. Mark Davis, discoverer of the first T-cell receptor genes and Stanford Professor, to advise the Company on immunological strategies for its novel cancer treatment platform

Lehi Utah, Jan. 07, 2026 (GLOBE NEWSWIRE) — Lehi, Utah, January 7, 2026 – CancerVax, Inc., the developer of a breakthrough universal cancer treatment platform that uses the body’s immune system to treat cancer, today announced that Mark M. Davis, PhD will serve as the Company’s Senior Scientific Advisor.

Dr. Davis was the founding Director of the Stanford Institute for Immunity, Transplantation and Infection (ITI), and turned it into an international leader in the development of transformative technologies and approaches to better understand the human immune system and its responses to infectious diseases and autoimmunity. He is currently a Professor of Microbiology and Immunology and the Director of the Center for Human Systems Immunology and co-Director of the Parker Center for the Immunotherapy of Cancer at Stanford.

Dr. Davis is well known for identifying the first T-cell receptor genes, which are responsible for T lymphocytes’ ability to “see” foreign pathogens such as viruses, solving a major mystery in immunology at that time. He and his research group have made many subsequent discoveries about this type of molecule, demonstrating that T-cells are able to detect and respond to even a single molecule of their ligand-fragments of antigens bound to Major Histocompatibility Complex cell surface molecules. He also developed a novel way of labeling specific T lymphocytes according to the molecules that they recognize, and this procedure is now an important method in many clinical and basic studies of T-cell activity, as are other technologies developed by his group.

CancerVax was founded on the idea that disguising cancer cells to resemble foreign pathogens, such as the measles virus, can effectively “trick” the immune system into recognizing and aggressively attacking them. The disguise is done by precisely detecting cancer cells at the genetic level, then forcing them to express harmless protein fragments associated with viruses. This then activates T-cell killing of cancer cells through the mechanisms that Dr. Davis discovered and continues to research. Recent in-vitro lab experiments have proven that this is possible with the CancerVax technology – a major milestone for the Company.

Dr. Davis, commented, “I’ve observed many novel cancer immunotherapies over the years. I find the CancerVax approach quite clever and interesting. Instead of teaching immune cells to recognize cancer through a new learned immunity, disguising cancer cells with viral antigens to activate strong existing immunity is a very exciting idea. I look forward to helping anyway I can.”

“Mark’s groundbreaking work and foundational discoveries revealed how T cells ‘see’ foreign antigens and transformed the world’s understanding of adaptive immunity. It is one of the most important advances in modern immunology,” said Dr. George Katibah, Chief Scientific Officer of CancerVax. “Dr. Davis has pioneered transformative technologies such as peptide-MHC tetramers and advanced systems-level approaches to human immunology, and his research continues to fuel translational innovations from vaccines to cancer therapies. His extraordinary scientific leadership and deep expertise align powerfully with CancerVax’s novel approach to treating cancer. It is a privilege for all of us at CancerVax to work with Dr. Davis.”

According to research.com, Dr. Davis has authored over 500 publications with over 125,000 citations. He has received numerous awards and honors for his work, including memberships in the National Academy of Sciences, The National Academy of Medicine and the Royal Society.

To learn more about the CancerVax platform, please watch the Short Explainer Video at https://cancervax.com/explainer

About CancerVax

CancerVax is a pre-clinical biotech company developing a novel Universal Cancer Treatment platform that will be customizable, as an injection, to treat many types of cancer. Our innovative approach DETECTS, MARKS, and KILLS only cancer cells. By making cancer cells look like well-immunized common diseases, such as measles or chickenpox, we intend to use the body’s natural immune system to easily kill the cancer cells. We look forward to the day when treating cancer will be as simple as getting a shot — a better way to fight cancer. To learn more, please visit www.CancerVax.com

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict, many of which are outside our control. Our actual results and financial condition may differ materially from those in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Any forward-looking statement made by us in this release is based only on information currently available to us and speaks only as of the date it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments, or otherwise.

Press Contact:
CancerVax, Inc.
Tel: (805) 356-1810
communications@CancerVax.com

Relation Announces Strategic Collaboration with Deerfield Management to Advance Novel Therapeutics

Relation Announces Strategic Collaboration with Deerfield Management to Advance Novel Therapeutics




Relation Announces Strategic Collaboration with Deerfield Management to Advance Novel Therapeutics

LONDON, Jan. 07, 2026 (GLOBE NEWSWIRE) — Relation and healthcare investment firm Deerfield Management, a current investor, today announced the establishment of a new research collaboration to advance therapeutic discovery projects for diseases of high unmet need.

“The opportunity to combine Relation’s and Deerfield’s capabilities across AI, biology, discovery and development is a compelling proposition,” said David Roblin, MD, CEO of Relation. “We believe that this partnership will enable us to expand our R&D efforts and portfolio and ultimately help patients in need.”

Relation is founded on the premise that better success in drug development requires confidence in the biology driving disease. To deliver this confidence in biology, Relation’s “Lab-in-the-Loop” platform aims to integrate state-of-the-art AI with patient-derived multi-omic data and proprietary experimental systems to uncover causal genes and refine target hypotheses. Relation develops medicines to clinical value inflection points across a range of therapy areas, all under the central theme of capitalising on better biological understanding. The company’s portfolio spans immunology, metabolic disease, and bone disease.

Under the terms of the agreement, Relation may nominate targets discovered using its platform for downstream development via a NewCo, jointly owned by the Parties. The parties will work collaboratively to develop target product profiles, and Deerfield will provide due diligence support and drug development plans for projects that the parties mutually decide to advance. Both Relation and Deerfield are entitled to royalties of the net sales of any future products.

“We are inspired by what the Relation team is working to achieve and look forward to collaborating as we strive to better understand target biology,” said Matt Nelson, PhD, VP, Genetics and Genomics at Deerfield Discovery and Development (3DC), Deerfield’s internal drug discovery and development engine. “In combining forces, we hope to expand the boundaries of what we know and leverage therapeutically relevant insights to make a difference for patients.”

About Relation

Relation is a technology-enabled biopharmaceutical company developing medicines across immunology, metabolic and bone diseases. The company builds AI and experimental systems, across the drug development cycle, all under the central theme of capitalising on better biological understanding.

About Deerfield Management

Deerfield is an investment management firm committed to advancing healthcare through investment, intelligence, and philanthropy. The Firm works across the healthcare ecosystem to connect people, capital, ideas, and technology in bold, collaborative, and inclusive ways. For more information, please visit www.deerfield.com.

Media contact:

press@relationrx.com

kimberly.ha@kkhadvisors.com