FoRx Therapeutics Announces USD 50M Series A Financing, Enabling Clinical Data Readout for Potential Best-in-Class PARG Inhibitor




FoRx Therapeutics Announces USD 50M Series A Financing, Enabling Clinical Data Readout for Potential Best-in-Class PARG Inhibitor

• Funding to support Phase 1 clinical development of best-in-class PARG inhibitor candidate FORX-428
• FORX-428 is potential new treatment option for patients whose cancers are resistant to, or have become resistant to, PARP inhibitors
• Initial data expected in mid-2026 from open-label Phase 1 study in advanced solid tumors

Basel, Switzerland – December 18, 2025 – FoRx Therapeutics, a clinical-stage biotechnology company developing precision anti-cancer therapeutics, today announced the close of an insider-led USD 50 million (CHF 40 million) Series A financing. The funding will be used to advance Phase 1 clinical development of its lead drug candidate, FORX-428, a potential best-in-class PARG (poly (ADP-ribose) glycohydrolase) inhibitor designed to target and disrupt the DNA Damage Response (DDR) in advanced solid tumors.

Existing investors including EQT Life Sciences, Pfizer Ventures, Novartis Venture Fund and M Ventures participated in the financing including a first closing in June 2024, which provided funding through the Investigational New Drug (IND) application for FORX-428 and the initiation of the Phase 1 trial.

Tarig Bashir, CEO of FoRx Therapeutics, said: “The FoRx team is proud to have earned the continued trust and conviction of this sophisticated syndicate of leading strategic and specialist investors. The funds from this investment will allow us to achieve initial clinical readout in our ongoing Phase 1 trial of FORX-428, which has shown very strong anti-tumor efficacy in multiple preclinical in vitro and in vivo tumor models. We are looking forward to reinforcing its best-in-class PARG inhibitor characteristics and potential to make a significant difference to patients, with initial clinical data expected in mid-2026.”

The discovery that distinct genetic subsets of cancer are exceptionally vulnerable to drugs that interfere with the DNA Damage Response (DDR) led to the approval of PARP inhibitors more than 10 years ago, transforming cancer treatment. FoRx is pursuing a next-generation DDR target, PARG, which shows significant potential as a new treatment for patients whose cancers are resistant to, or have become resistant to, PARP inhibitors.

Vincent Brichard (EQT Life Sciences), Board member at FoRx Therapeutics, said: “Advances in PARG inhibition hold significant potential as a therapeutic strategy in Oncology. Our syndicate’s continued support of FoRx reflects our confidence in both, the lead candidate FORX-428, and the strong progress achieved by its experienced management team.”

FoRx’s ongoing first-in-human Phase 1study of FORX-428, a novel PARG inhibitor targeting the DDR in advanced solid tumors is progressing as planned, with initial data readout expected by mid-2026. The open-label study, which began recruitment in August 2025 in the United States, is evaluating safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors who have exhausted standard-of-care options.

FORX-428 is a proprietary, orally available small molecule inhibitor of poly (ADP-ribose) glycohydrolase (PARG). PARG is a DNA repair enzyme considered important for the survival of certain genetically defined cancers with specific DDR deficiencies or high replication stress. In preclinical studies, FORX-428 demonstrated robust anti-tumor activity across multiple solid tumor types underscoring the novel compound’s outstanding potential in both monotherapy and combination settings. FORX-428 was well tolerated, demonstrating drug-like pharmacology and a favorable safety profile.

About FoRx Therapeutics

FoRx Therapeutics is a privately held clinical-stage biotechnology company pioneering precision therapeutics targeting the DNA Damage Response in treatment-resistant cancers. Its lead product candidate FORX-428, an oral small molecule PARG inhibitor, is in Phase 1 testing to treat advanced solid tumors.

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• 20251218 FoRx Series A_Final

EssilorLuxottica and Burberry announce licensing partnership renewal




EssilorLuxottica and Burberry announce licensing partnership renewal

EssilorLuxottica and Burberry
announce licensing partnership renewal

Paris, France and London, United Kingdom (18 December 2025) – EssilorLuxottica and Burberry today announced the renewal of their licensing agreement for the development, production and global distribution of eyewear under the Burberry brand.

The existing agreement, expiring on December 31, 2025, has been extended through December 31, 2035.

Building on a shared legacy of creativity, craftsmanship and innovation, the renewal reinforces a long-standing partnership between the two companies that has flourished since 2006.

“We are delighted to extend our two-decade partnership with Burberry, a creative journey that has brought to life collections infused with Burberry’s timeless sophistication and uniquely British allure. As we look ahead to the next chapter of crafting Burberry-branded eyewear, EssilorLuxottica is thrilled to deepen its collaboration with one of the world’s most admired luxury houses”, commented Francesco Milleri, Chairman and CEO of EssilorLuxottica.

Joshua Schulman, CEO of Burberry, added “We are thrilled to continue our longstanding partnership with EssilorLuxottica, building on a relationship grounded in craftsmanship, design and innovation. Together, we will capture the spirit of our timeless British luxury brand expression as we bring more iconic Burberry eyewear collections to customers around the world.”

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• DOWNLOAD THE PRESS RELEASE

DXS International plc (AQSE:DXSP) Notice of Cyber Security Incident




DXS International plc (AQSE:DXSP) Notice of Cyber Security Incident

18 December 2025

DXS INTERNATIONAL PLC (AQSE: DXSP)

Notice of Cyber Security Incident

The Board of DXS International plc (“the Company” or “DXSP”), the AQSE Growth Market quoted healthcare information and digital clinical decision support systems provider, reports that it has suffered a security incident affecting its office servers, which was discovered in the early hours of Sunday morning, the 14^th December.

Once discovered, the data security breach was immediately contained by means of a joint effort by DXS’s internal IT security teams in close cooperation with NHS England. The Board has appointed an external cyber security specialist agency whose thorough investigations are underway to establish the nature and extent of the incident.

The Company has notified the relevant regulators, authorities, and law enforcement agencies, including the Information Commissioner’s Office, and various NHS bodies and is fully cooperating with their investigations.  

There was minimal impact on the Company’s services and the Company’s front-line clinical services remain unaffected and operational.

The Company does not currently anticipate that this incident will have a material adverse impact on its financial position or on the market forecasts for its financials for FY 30 April 2026.

The Company will inform the market if there are any notifiable changes to the situation.

The Directors of DXS International plc accept responsibility for this announcement.

This announcement contains inside information for the purposes of Article 7 of the UK version of Regulation (EU) No 596/2014 which is part of UK law by virtue of the European Union (Withdrawal) Act 2018, as amended (“MAR”). Upon the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

Contacts :

Notes to Editors

About DXS:

DXS International presents up to date treatment guidelines and recommendations, from Clinical Commissioning Groups and other trusted NHS sources, to doctors, nurses and pharmacists in their workflow and during the patient consultation. This effective clinical decision support ultimately translates to improved healthcare outcomes delivered more cost effectively and which should significantly contribute towards the NHS achieving its projected efficiency savings.

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• DXS 18 12 2025_Notice of Cyber Security Incident_ final

GlucoModicum unveils Sofio™, the world’s first needle-free glucose monitor based on magneto-hydrodynamics (MHD)




GlucoModicum unveils Sofio™, the world’s first needle-free glucose monitor based on magneto-hydrodynamics (MHD)

PRESS RELEASE — FOR IMMEDIATE RELEASE

GlucoModicum unveils Sofio™, the world’s first needle-free glucose monitor based on magneto-hydrodynamics (MHD)

• MHD technology draws micro-sample through skin; glucose is measured using established electrochemical sensor technology
• Single-day sensor system offers periodic and personalized monitoring alternative to continuous glucose monitoring devices
• Extensive multi-year clinical studies (N>2,000) have demonstrated accuracy, supporting a clear pathway toward CE marking

Helsinki, Finland, 18 December – GlucoModicum today introduces Sofio™, a new glucose monitoring device that measures glucose through skin without using needles, supported by extensive multi-year clinical studies.

Sofio uses patented magnetohydrodynamics (MHD) to draw a micro-sample of interstitial fluid through skin, where glucose is measured using established glucose oxidase enzyme chemistry, the same method used in medical-grade glucose meters and CGMs.

“Needle-free glucose monitoring has been one of the most elusive goals in diabetes management for over thirty years,” said Jokke Mäki, CEO of GlucoModicum. “Our MHD-based approach takes a different route, enabling accurate glucose measurement without needles while relying on the established biosensing chemistry used in clinical devices.”

Designed for people who don’t need 24/7 monitoring

Sofio has been developed with the understanding that Type 2 diabetes is not static. Glucose patterns shift with lifestyle, medication, genetics and age. Most people with Type 2 diabetes don’t need a sensor attached to them for weeks. Sofio enables single-day glucose monitoring sessions whenever deeper insights are needed – during dietary or lifestyle changes, medication adjustments, or periodic checkups.

The system includes a durable, rechargeable transmitter (lasting up to two years) and a gentle, replaceable single-day sensor, offering an accessible and flexible alternative for people who want clarity without continuous wear.

Clinically demonstrated and ready for scale

GlucoModicum has conducted extensive clinical studies (N>2000), showing accuracy in line with regulatory expectations for interstitial glucose monitoring. The core sampling and detection principles have also undergone independent peer review, supporting the scientific foundation of the device.

Sofio is engineered for mass manufacturability, with production partnerships established with leading global medical device contract manufacturers. The company is progressing through European regulatory pathways, with additional regulatory and commercial updates expected in 2026. GlucoModicum is also advancing its U.S. go-to-market and FDA pathway, with further details to be communicated in 2026.                  

Learn more: www.sofio.health.

About GlucoModicum

GlucoModicum is a Finnish medical technology company developing needle-free biosensing solutions powered by magnetohydrodynamic fluid sampling. The company’s mission is to make high-quality metabolic insights accessible to millions of people through clinically validated science and user-centered design. Sofio™ is the first commercial application of this technology.

Media Contact:
ICR Healthcare, Chris Welsh / Evi Useh
glucomodicum@icrhealthcare.com
www.sofio.health
www.glucomodicum.com

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• Sofio by GlucoModicum

InnoCare Announces Approval of Phase II/III Clinical Trial of Novel TYK2 Inhibitor Soficitinib for Chronic Spontaneous Urticaria in China




InnoCare Announces Approval of Phase II/III Clinical Trial of Novel TYK2 Inhibitor Soficitinib for Chronic Spontaneous Urticaria in China

BEIJING, Dec. 17, 2025 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today the approval of the Investigational New Drug (IND) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct a Phase II/III clinical trial of novel TYK2 inhibitor soficitinib (ICP-332) for the treatment of chronic spontaneous urticaria (CSU).

Soficitinib is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders. The current indications under development are strategically positioned within the vast dermatology market, including atopic dermatitis, vitiligo, prurigo nodularis, CSU, and more. TYK2 plays a key role in the JAK-STAT signaling pathway and is critical in the pathogenesis of inflammatory diseases.

Soficitinib blocks signaling pathways such as lL-4, IL-13, IL-31, and other cytokines that drive mast cell activation and inflammation, reducing itch and wheals in CSU.

CSU is characterized by recurrent wheals and itch, with a disease course typically lasting two to five years, and in some patients, even exceeding five years. China has a large population of CSU patients, a condition that is prone to recurrent episodes. The intense nighttime itching severely disrupts daily life. Long-term, systematic, and standardized treatment is therefore essential for disease control.

There are approximately 50 million CSU patients worldwide¹, and the global CSU treatment market is expected to reach $3 billion in 2029².

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, “InnoCare’s pipeline under development covers ten major autoimmune diseases, with our TYK2 inhibitors deeply positioned in the field of dermatology. We are accelerating the clinical development of soficitinib to address huge unmet medical needs. We hope this innovative drug will benefit more autoimmune disease patients as early as possible.”

About InnoCare
InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

¹ DOI: 10.1007/s12325-025-03172-0
² The Business Research Company

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Sapu BioScience Highlights TGFB2-Guided Strategy to Enhance Taxane Therapies, Reinforcing the Rationale for Sapu-001




Sapu BioScience Highlights TGFB2-Guided Strategy to Enhance Taxane Therapies, Reinforcing the Rationale for Sapu-001

San Diego, CA, Dec. 17, 2025 (GLOBE NEWSWIRE) — Sapu BioScience today announced the publication of a new peer-reviewed study in the International Journal of Molecular Sciences that strengthens the scientific foundation for biomarker-guided taxane therapy and underscores the company’s long-standing leadership in transforming growth factor-beta 2 (TGFB2) biology.

Bioinformatic Approach to Identify Positive Prognostic TGFB2-Dependent and Negative Prognostic TGFB2-Independent Biomarkers for Breast Cancers. Qazi S, Richardson S, Potts M, Myers S, Trieu V. Int J Mol Sci. 2025 Nov 29;26(23):11580. doi: 10.3390/ijms262311580. PMID: 41373732; PMCID: PMC12692321.

The publication demonstrates that TGFB2 is not merely a prognostic marker, but a biological context-setter that determines whether patients derive benefit from standard chemotherapy such as taxanes. This insight has direct relevance for Sapu’s taxane program Sapu-001, which is designed to improve the effectiveness and tolerability of taxane treatment through precision patient selection and optimized delivery.

Sapu BioScience has been developing TGFB2-targeted antisense therapeutics, establishing one of the deepest proprietary knowledge bases around this pathway in oncology. That work has generated a broad intellectual-property position covering TGFB2 modulation across multiple tumor types and therapeutic settings.

“Taxanes remain a backbone of breast cancer treatment, but many patients experience limited benefit or unnecessary toxicity. The study shows that TGFB2-defined tumor biology strongly influences chemotherapy response, creating a clear opportunity to improve outcomes through smarter patient selection.” said Dr. Vuong Trieu, CEO of Sapu BioScience. “Together, TGFB2 antisense know-how and Sapu-001 form a coherent, precision-oncology strategy—one that combines pathway-level biology with optimized chemotherapy delivery.”

About Sapu-001

The Sapu-001 (Paclitaxel Deciparticles for Injection) is led by a team with a proven track record in taxane development. Members of the Sapu BioScience leadership team were instrumental in the development and commercialization of Abraxane^®, the first albumin-bound nanoparticle formulation of paclitaxel, as well as Cynviloq™, a polymeric micelle-based paclitaxel designed to eliminate solvent-related toxicities. Sapu-001 builds directly on this legacy, combining deciparticle formulation expertise with TGFB2-driven biological insight.

Investor & Media Contact
Sapu Nano (US) LLC
Investor Relations
ir@sapubio.com

Sapu BioScience Highlights TGFB2-Guided Strategy to Enhance Taxane Therapies, Reinforcing the Rationale for Sapu-001




Sapu BioScience Highlights TGFB2-Guided Strategy to Enhance Taxane Therapies, Reinforcing the Rationale for Sapu-001

San Diego, CA, Dec. 17, 2025 (GLOBE NEWSWIRE) — Sapu BioScience today announced the publication of a new peer-reviewed study in the International Journal of Molecular Sciences that strengthens the scientific foundation for biomarker-guided taxane therapy and underscores the company’s long-standing leadership in transforming growth factor-beta 2 (TGFB2) biology.

Bioinformatic Approach to Identify Positive Prognostic TGFB2-Dependent and Negative Prognostic TGFB2-Independent Biomarkers for Breast Cancers. Qazi S, Richardson S, Potts M, Myers S, Trieu V. Int J Mol Sci. 2025 Nov 29;26(23):11580. doi: 10.3390/ijms262311580. PMID: 41373732; PMCID: PMC12692321.

The publication demonstrates that TGFB2 is not merely a prognostic marker, but a biological context-setter that determines whether patients derive benefit from standard chemotherapy such as taxanes. This insight has direct relevance for Sapu’s taxane program Sapu-001, which is designed to improve the effectiveness and tolerability of taxane treatment through precision patient selection and optimized delivery.

Sapu BioScience has been developing TGFB2-targeted antisense therapeutics, establishing one of the deepest proprietary knowledge bases around this pathway in oncology. That work has generated a broad intellectual-property position covering TGFB2 modulation across multiple tumor types and therapeutic settings.

“Taxanes remain a backbone of breast cancer treatment, but many patients experience limited benefit or unnecessary toxicity. The study shows that TGFB2-defined tumor biology strongly influences chemotherapy response, creating a clear opportunity to improve outcomes through smarter patient selection.” said Dr. Vuong Trieu, CEO of Sapu BioScience. “Together, TGFB2 antisense know-how and Sapu-001 form a coherent, precision-oncology strategy—one that combines pathway-level biology with optimized chemotherapy delivery.”

About Sapu-001

The Sapu-001 (Paclitaxel Deciparticles for Injection) is led by a team with a proven track record in taxane development. Members of the Sapu BioScience leadership team were instrumental in the development and commercialization of Abraxane^®, the first albumin-bound nanoparticle formulation of paclitaxel, as well as Cynviloq™, a polymeric micelle-based paclitaxel designed to eliminate solvent-related toxicities. Sapu-001 builds directly on this legacy, combining deciparticle formulation expertise with TGFB2-driven biological insight.

Investor & Media Contact
Sapu Nano (US) LLC
Investor Relations
ir@sapubio.com

Aveanna to Participate at the 44th Annual J.P. Morgan Healthcare Conference




Aveanna to Participate at the 44th Annual J.P. Morgan Healthcare Conference

ATLANTA, Dec. 17, 2025 (GLOBE NEWSWIRE) — Aveanna Healthcare Holdings Inc. (“Aveanna”) (NASDAQ: AVAH) today announced that its management team will attend the 44^th Annual J.P. Morgan Healthcare Conference in San Francisco on January 14, 2026.

Management will present at 9:45 a.m. PST followed by 1×1 investor meetings on the same day, January 14, 2026. Interested investors and other parties may also listen to a simultaneous webcast of the presentation by logging onto the Investor Relations section of the Company’s website at https://ir.aveanna.com/. The online replay will be available for a limited time shortly following the call.

About Aveanna Healthcare

Aveanna Healthcare is headquartered in Atlanta, Georgia and has locations in 38 states providing a broad range of pediatric and adult healthcare services including nursing, rehabilitation services, occupational nursing in schools, therapy services, day treatment centers for medically fragile and chronically ill children and adults, home health and hospice services, as well as delivery of enteral nutrition and other products to patients. The Company also provides case management services in order to assist families and patients by coordinating the provision of services between insurers or other payers, physicians, hospitals, and other healthcare providers. In addition, the Company provides respite healthcare services, which are temporary care provider services provided in relief of the patient’s normal caregiver. The Company’s services are designed to provide a high quality, lower cost alternative to prolonged hospitalization. For more information, please visit www.aveanna.com.

CONTACT: Investor Contact

Matt Buckhalter
Chief Financial Officer ir@aveanna.com

Hong Kong Pharma Digital Announced Results of 2025 Annual Meeting of Stockholders




Hong Kong Pharma Digital Announced Results of 2025 Annual Meeting of Stockholders

HONG KONG, Dec. 17, 2025 (GLOBE NEWSWIRE) — Hong Kong Pharma Digital Technology Holdings Limited (NASDAQ: HKPD) (“HKPD” or the “Company”), a leading provider of over the counter (“OTC”) pharmaceutical cross-border e-commerce supply chain services in Hong Kong, today announced that all proposals at the Company’s 2025 annual meeting of stockholders held on December 12, 2025 local time were duly passed. The shareholders of the Company passed and approved the following proposals:

Proposal No. 1: The re-election of five directors, Chenyu Liang, Lap Sun Wong, Mike Yao Zhou, Jingyan Wu, Dr. Kam Leung Chan, each to serve until the 2026 Annual Meeting of Stockholders;

Proposal No. 2: The ratification of the appointment of Onestop Assurance PAC as the Company’s independent registered public accounting firm for the fiscal year ending March 31, 2026;

Proposal No. 3: The increase of the authorized share capital of the Company from US$100,000 divided into 100,000,000 ordinary shares of par value of $0.001 each, to US$1,000,000 divided into 1,000,000,000 ordinary shares of par value of US$0.001.

Proposal No. 4: The re-designation and re-classification from ordinary shares of a single class to Class A ordinary shares and Class B ordinary shares.

Proposal No. 5: The approval and implementation of the Reverse Share Split and Share Consolidation of the Company’s issued and outstanding Ordinary Shares.

Proposal No. 6: The Company’s name be changed from “Hong Kong Pharma Digital Technology Holdings Limited” to “Cellyan Biotechnology Co., Ltd” and the Company’s foreign name be changed from “港药数字科技控股有限公司” to “生研生物公司”.

Proposal No. 7: The fourth amended and restated memorandum and articles of association of the Company be adopted.

Proposal No. 8: The repurchase by the Company of 7,150,000 Class A Ordinary Shares registered in the name of TUTU Business Services Limited and issue of Class B Ordinary Shares;

Proposal No. 9: The adoption and approval of the Hong Kong Pharma Digital Technology Holdings Limited 2025 Equity Incentive Plan;

For the full text of the above proposals passed and approved at the 2025 AGM, refer to the Form 6-K furnished to the SEC on December 17, 2025.

About Hong Kong Pharma Digital Technology Holdings Limited

Hong Kong Pharma Digital Technology Holdings Limited offers two main categories of services: (i) OTC pharmaceutical cross-border e-commerce supply chain services through its Hong Kong subsidiary, Joint Cross Border Logistics Company Limited (“Joint Cross Border”), and (ii) OTC pharmaceutical cross-border procurement and distribution through its Hong Kong subsidiary, V-Alliance Technology Supplies Limited.

Through its engagement with OTC pharmaceutical suppliers, logistics companies, and merchants on Chinese e-commerce platforms, Joint Cross Border provides a convenient one-stop solution for Mainland Chinese customers seeking access to OTC pharmaceutical products outside Mainland China.

Joint Cross Border’s comprehensive service offerings include pre-consultation, product information review, procuring overseas OTC pharmaceutical products, enlisting products with the Hong Kong Department of Health, obtaining import and export permits, storing products, packaging, and arranging logistics and end-to-end delivery services for customers.

For more information, please visit the Company’s website: www.9zt.hk.

Forward-Looking Statements

All forward-looking statements, expressed or implied, in this release are based only on information currently available to us and speak only as of the date on which they are made. Investors can find many (but not all) of these statements by the use of words such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may” or other similar expressions in this release. Except as otherwise required by applicable law, we disclaim any duty to publicly update any forward-looking statement to reflect events or circumstances after the date of this release. These statements are subject to uncertainties and risks, including, but not limited to, the uncertainties related to market conditions, and other factors discussed in our filings with the SEC. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the Company’s filings with the SEC. Additional factors are discussed in the Company’s filings with the SEC, which are available for review at www.sec.gov.

For investor and media inquiries please contact:

Hong Kong Pharma Digital Technology Holdings Limited

Media Contact: andy@cell-yan.com 

Investor Relations: stella @cell-yan.com

Immuneering Advances Towards Dosing First Patient in Phase 3 Atebimetinib Trial for First-Line Metastatic Pancreatic Cancer Patients, Securing Alignment with FDA and EMA




Immuneering Advances Towards Dosing First Patient in Phase 3 Atebimetinib Trial for First-Line Metastatic Pancreatic Cancer Patients, Securing Alignment with FDA and EMA

– End-of-Phase 2 interactions with FDA complete; scientific advice received from EMA –

– Company expects to dose first patient in global Phase 3 registrational trial, MAPKeeper 301, in mid-2026 –

– Overall survival update for Phase 2a trial of atebimetinib + mGnP in first-line pancreatic cancer patients planned in coming weeks –

NEW YORK, Dec. 17, 2025 (GLOBE NEWSWIRE) — Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, today announced that it is on track to dose the first patient in its planned global Phase 3 registrational trial in first line pancreatic cancer patients in mid-2026, evaluating atebimetinib (320 mg QD) in combination with modified gemcitabine and nab-paclitaxel (mGnP), compared with gemcitabine and nab-paclitaxel (GnP) alone.

Notably, the company completed its End-of-Phase 2 (EOP2) interactions with the U.S. Food and Drug Administration (FDA) and received scientific advice from the European Medicines Agency (EMA). Immuneering achieved alignment with both agencies on the key elements of the company’s proposed Phase 3 trial.

“We are very pleased with our interactions with both the FDA and EMA, which we believe speaks to the compelling data we have generated to date in first-line pancreatic cancer, as well as the strength and simplicity of our proposed Phase 3 trial for atebimetinib,” said Ben Zeskind, Ph.D., Co-Founder and Chief Executive Officer of Immuneering. “Importantly, the regulators’ feedback supports our trial design and key primary endpoint of overall survival, and we are confident that our team is well-positioned to begin dosing patients in this global registrational trial in mid-2026. We are also thrilled to expand the planned trial to 510 patients, which gives more first-line pancreatic cancer patients the opportunity to participate, and further increases statistical robustness. In addition, we are excited to provide an update on overall survival in the Phase 2a trial in the coming weeks.”

MAPKeeper 301 is designed as a global Phase 3 trial that will evaluate atebimetinib (320 mg QD) in combination with mGnP, compared to standard of care GnP alone, in first-line metastatic pancreatic ductal adenocarcinoma. The primary endpoint of the trial is overall survival, and secondary endpoints include progression-free survival, overall response rate, disease control rate, and quality of life measurements. Immuneering plans to enroll a total of approximately 510 patients in the Phase 3 trial.

The company expects to dose the first patient in mid-2026 and share topline results from the trial in mid-2028. Immuneering also reiterated management’s belief that the company’s current cash and cash equivalents, based on current operating plans, are sufficient to fund operations into 2029.

“The constructive guidance from both agencies validates our scientific approach and our understanding of the unmet need in first-line metastatic pancreatic cancer,” said Igor Matushansky, M.D., Ph.D., Chief Medical Officer of Immuneering. “We look forward to advancing atebimetinib into Phase 3 and working with investigators worldwide to bring this potentially transformative therapy to patients as expeditiously as possible.”

“New therapies for pancreatic cancer are urgently needed,” said Eileen M. O’Reilly, MD, FASCO, Winthrop Rockefeller Endowed Chair in Medical Oncology at Memorial Sloan Kettering Cancer Center. “The phase IIa data of atebimetinib and chemotherapy shows a promising signal. I am excited to see this combination move forward to a randomized phase III evaluation.”

About Immuneering Corporation

Immuneering is a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive. The Company is developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors. Immuneering’s lead product candidate, atebimetinib, is an oral, once-daily Deep Cyclic Inhibitor of MEK, designed to improve durability and tolerability across many cancer indications, including MAPK pathway-driven tumors such as pancreatic cancer. Atebimetinib is currently planned to be evaluated in a Phase 3 trial in first-line pancreatic cancer, which is expected to begin dosing in mid-2026. The Company’s development pipeline also includes early-stage programs. For more information, please visit www.immuneering.com.

Forward-Looking Statements

This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: our plans to develop, manufacture and commercialize our product candidates; the treatment potential of atebimetinib, alone or in combination with other agents to treat cancer, including modified Gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer; the timing of future data updates; the regulatory feedback supporting our Phase 3 trial design and initiation of the trial, including the key primary endpoint of overall survival and validating our scientific approach, expectations regarding our cash runway; the timing of dosing the first patient and topline readout in our planned phase 3 trial; and our belief that our regulatory interactions speak to the compelling data we have generated to date in first-line pancreatic cancer, as well as the strength and simplicity of our proposed Phase 3 trial for atebimetinib.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in oncology drug research and development, including target discovery, target validation, lead compound identification, and lead compound optimization; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway; our need for additional funding; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports.

These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended September 30, 2025, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Media Contact:
Carson Creehan
202-878-8330
Carson.creehan@padillaco.com

Investor Contact:
Laurence Watts
619-916-7620
laurence@newstreetir.com