Mdxhealth and University of Oxford to validate GPS test in largest randomized trial of treatment effectiveness in patients with localized prostate cancer




Mdxhealth and University of Oxford to validate GPS test in largest randomized trial of treatment effectiveness in patients with localized prostate cancer

Mdxhealth and University of Oxford to validate GPS test in largest randomized trial of treatment effectiveness in patients with localized prostate cancer

IRVINE, CA – January XX, 2026 (GlobeNewswire) – Mdxhealth SA (NASDAQ: MDXH) (the “Company” or “mdxhealth”), a leading precision diagnostics company, today announced the next major phase of its collaboration with the University of Oxford: the initiation of Genomic Prostate Score (GPS) testing in the landmark UK ProtecT trial (Prostate Testing for Cancer and Treatment). This study is designed to establish GPS as the first genomic classifier supported by randomized clinical trial evidence in an Active Surveillance cohort, further validating the clinical utility of GPS in predicting prostate cancer progression and long-term treatment outcomes.

Michael K. McGarrity, Chief Executive Officer of mdxhealth, commented: “This is a transformative moment for prostate cancer precision diagnostics – no other patient cohort combines this level of rigor, long-term follow-up, and potential impact on clinical practice guidelines, payer coverage and provider adoption for patients diagnosed with localized prostate cancer.”

The ProtecT Trial

The UK ProtecT (Prostate Testing for Cancer and Treatment) trial is widely regarded as the world’s largest randomized clinical trial of treatment effectiveness in localized prostate cancer. Following more than 1,500 men with localized disease for over two decades, the study provides unmatched long-term clinical outcome data across AS/AM, Radical Prostatectomy (RP), and Radiotherapy (RT).

Professor Hamdy, University of Oxford, commented: “The ProtecT trial has contributed to shaping international standards for prostate cancer management. By incorporating the Genomic Prostate Score (GPS) test, we are building on decades of outcomes data with genomic insights that could redefine how physicians evaluate risk and personalize care for patients worldwide.”

This study builds on the partnership announced in September 2023, in which mdxhealth and Oxford began evaluating the correlation between GPS and prostate cancer progression using samples from the well-annotated ProMPT cohort. With the ProMPT validation successfully completed, the initiation of the GPS-ProtecT study will now leverage one of the most definitive, long-term prostate cancer sample- and data-sets in the world to demonstrate the predictive power of GPS in the context of a mature prospective, randomized trial.

About Mdxhealth

Mdxhealth is a leading precision diagnostics company that provides actionable molecular information to personalize patient diagnosis and treatment. The Company’s tests are based on proprietary genomic, epigenetic (methylation), exosomal and other molecular technologies and assist physicians with the diagnosis and prognosis of prostate cancer and other urologic diseases. The Company’s U.S. headquarters and laboratory operations are in Irvine, California, with additional laboratory operations in Waltham, Massachusetts and Plano, Texas. European headquarters are in Herstal, Belgium. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.

Forward-Looking Statement: This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “potential,” “expect,” “will,” “goal,” “next,” “potential,” “aim,” “explore,” “forward,” “future,” and “believes” as well as similar expressions. Forward-looking statements contained in this release include, but are not limited to, statements regarding expected future product development and performance results; our strategies, positioning, resources, capabilities and expectations for future events or performance; and the anticipated timing and benefits of our acquisitions, including estimated synergies and other financial impacts. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company’s control, and may turn out to be materially different. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, product development efforts, our strategies, positioning, resources, capabilities and expectations for future events or performance. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully and profitably market our products; the acceptance of our products and services by healthcare providers; our ability to achieve and maintain adequate levels of coverage or reimbursement for our current and future solutions we commercialize or may seek to commercialize; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; our ability to obtain and maintain regulatory approvals and comply with applicable regulations; timing, progress and results of our research and development programs; the period over which we estimate our existing cash will be sufficient to fund our future operating expenses and capital expenditure requirements; our ability to remain in compliance with financial covenants made to and make scheduled payments to our creditors; the possibility that the anticipated benefits from our business acquisitions like our acquisition of the ExoDx business and GPS prostate cancer business will not be realized in full or at all or may take longer to realize than expected; and the amount and nature of competition for our products and services. Other important risks and uncertainties are described in the Risk Factors sections of our most recent Annual Report on Form 20-F and in our other reports filed with the Securities and Exchange Commission. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws.

NOTE: The mdxhealth logo, mdxhealth, Confirm mdx, Select mdx, Resolve mdx, Genomic Prostate Score, Exosome Diagnostics, ExosomeDx, ExoDx, ExoDx Prostate Intelliscore (EPI), and Monitor mdx are trademarks or registered trademarks of MDxHealth SA and its affiliates. The GPS test was formerly known as and is frequently referenced in guidelines, coverage policies, reimbursement decisions, manuscripts and other literature as Oncotype DX Prostate, Oncotype DX GPS, Oncotype DX Genomic Prostate Score, and Oncotype Dx Prostate Cancer Assay, among others.  The Oncotype DX trademark, the Bio-Techne trademark, and all other trademarks and service marks, are the property of their respective owners.

For more information: 
info@mdxhealth.com

LifeSci Advisors (IR & PR)
John Fraunces
Managing Director
Tel: +1 917 355 2395
Jfraunces@lifesciadvisors.com
ir@mdxhealth.com

Attachment

• mdx2026

Syncromune Continues to Strengthen Executive and Clinical Leadership with Appointment of Dr. Stephen P. Dale, M.D., as Chief Medical Officer




Syncromune Continues to Strengthen Executive and Clinical Leadership with Appointment of Dr. Stephen P. Dale, M.D., as Chief Medical Officer

FORT LAUDERDALE, Fla. and WEST DES MOINES, Iowa, Jan. 06, 2026 (GLOBE NEWSWIRE) — Syncromune^® Inc., a clinical-stage biopharmaceutical company dedicated to the development of SYNC-T™, an in situ platform combination immunotherapy optimized for solid tumor cancers, today announced the appointment of Stephen P. Dale, M.D., as Chief Medical Officer.

“Our priority at Syncromune is to develop therapies that meaningfully improve the lives of patients facing some of the most challenging cancers,” said Chuck Link, M.D., Adjunct Professor at the Lankenau Institute for Medical Research (LIMR) and Co-Founder and Executive Chairman at Syncromune. “By combining Dr. Dale’s physician perspective and patient-focused approach to clinical development, we will ensure our programs prioritize safety and impact as we advance our clinical objectives.”

Dr. Dale brings more than 20 years of global oncology research and development (R&D) leadership to Syncromune, with deep experience across both biotechnology and large pharmaceutical organizations. He has led early- and late-stage clinical development and translational strategy efforts, contributing to multiple regulatory approvals. His expertise includes guiding programs through pivotal trial design, first-in-class dose optimization, and IND-enabling studies in alignment with evolving FDA and EMA guidance.

Prior to joining Syncromune, Dr. Dale served as Head of R&D and Chief Medical Officer at Kura Oncology. He previously held senior oncology R&D and clinical leadership roles at Kyowa Kirin and AstraZeneca, where he led global development programs across solid and hematological tumors, immuno-oncology, precision oncology, and rare diseases. He obtained his Doctor of Medicine and MBChB degrees from the University of Manchester Medical School.

As Chief Medical Officer of Syncromune, Dr. Dale will lead the clinical development of SYNC-T, provide strategic and medical oversight for the company’s expanding pipeline, and play a central role in shaping Syncromune’s clinical, regulatory, and translational roadmap moving forward.

Eamonn Hobbs, Co-Founder, President, and Chief Executive Officer of Syncromune added, “Dr. Dale’s oncology experience and proven leadership in advancing innovative therapies through clinical development make him an exceptional addition to our team. His expertise will be invaluable as we progress SYNC-T Therapy SV-102 through Phase 2 and broaden the platform’s potential across solid tumors. We are thrilled to welcome him at this important stage of Syncromune’s growth.”

“I’m honored to join Syncromune at this pivotal juncture in its evolution,” said Dr. Dale. “Syncromune’s vision to deliver multi-target immunotherapies that activate the immune system locally while minimizing systemic exposure and toxicity reflects the patient-centered innovation that has guided my career. I’m eager to partner with the team to accelerate therapies that offer new possibilities for patients with few or no effective treatment options.”  

About Syncromune^® and SYNC-T™ Therapy

Syncromune is a privately held, clinical-stage biopharmaceutical company dedicated to the development of SYNC-T, a potentially first-in-class platform immunotherapy designed to address major unmet medical needs and treatment challenges of metastatic solid tumor cancers. SYNC-T is an in situ personalized cancer therapy engineered to synchronize the location of three components critical to T cell activation and an anti-tumor immune response. SYNC-T features a novel proprietary needle-like device delivery system that is optimized for combination drug/device immunotherapy. First, the system lyses a portion of a target tumor via a proprietary freeze/thaw method to rupture tumor cells and release patient-specific tumor antigens into the tumor microenvironment (TME) that helps to activate the immune system. Next, the delivery system facilitates the infusion of our proprietary multi-target biologic drug directly into the lysed area of the tumor. This approach of location synchronization is designed to unite the three critical components of patient-specific tumor antigens, immune cells, and our multi-target biologic drug together in the draining lymphatics where the immune system optimally functions. The combination therapy targets numerous mechanisms of cancer, promoting in situ immune activation while also battling immune suppression and minimizing systemic drug exposure. The goal is to educate the immune system and activate T cells that can recognize and attack cancer throughout the body and defend with immune memory. Our lead candidate, SYNC-T Therapy SV-102 for metastatic castration-resistant prostate cancer (mCRPC), is being evaluated in the LEGION-100 U.S., multicenter, Phase 2 trial. For more information, please visit www.legion100trial.com.

This press release includes forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements contained in this press release or expressed orally in connection herewith that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, forward-looking statements can be identified by phrases such as “plans,” “intends,” “believes,” “expects,” “anticipates,” “foresees,” “forecasts,” “estimates” or other words or phrases of similar import. Similarly, statements herein that describe our business strategy, outlook, objectives, plans, intentions or goals also are forward-looking statements. All such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Accordingly, you should not place undue reliance on our forward-looking statements. The forward-looking statements contained in this press release or expressed orally in connection herewith are made only as of the date of this press release and we undertake no obligation to update the forward-looking statements to reflect subsequent events or circumstances, except as required by applicable law. None of Syncromune, Inc., its affiliates or their respective directors, officers, employees or agents gives any representation or warranty, express or implied, as to: (i) the achievement or reasonableness of future projections, management targets, estimates or prospects contained in this press release; or (ii) the accuracy or completeness of any information contained in this press release, any other written information or oral information provided in connection herewith or any data that any of them generates. This press release was prepared by us for informational purposes only and does not constitute an offer, or solicitation of an offer, to sell any securities at any time. None of Syncromune’s securities have been registered under the Securities Act of 1933, as amended, or any state securities law. Such securities have not been approved or disapproved by the Securities and Exchange Commission or by any state securities regulatory authority, nor has the Securities and Exchange Commission or any such state authority passed on the accuracy or adequacy of this press release. Any representation to the contrary is a criminal offense. Some of the information contained in this press release may be derived from information provided by industry sources. We believe that such information is accurate and that the sources from which it has been obtained are reliable; however, we cannot guarantee the accuracy of such information and have not independently verified such information.

Contact

Maggie Whitney
LifeSci Communications
mwhitney@lifescicomms.com

Danielle Hobbs
Syncromune, Inc.
EVP, Marketing & Commercial Strategy
media@syncromune.com

CG Oncology to Present at the 44th Annual J.P. Morgan Healthcare Conference




CG Oncology to Present at the 44th Annual J.P. Morgan Healthcare Conference

IRVINE, Calif., Jan. 06, 2026 (GLOBE NEWSWIRE) — CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced that Arthur Kuan, Chairman & Chief Executive Officer, and Ambaw Bellete, President & Chief Operating Officer, will present at the 44th Annual J.P. Morgan Healthcare Conference on January 15, 2026, at 8:15 am PT / 11:15 am ET. The conference is taking place at the Westin St. Francis San Francisco, California.

Interested parties may access the live audio webcast for this conference from the Investor Relations section of the company’s website at www.cgoncology.com. The webcast replay will be available shortly after the conclusion of the live presentation and archived for approximately 90 days.

About CG Oncology
CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com.

Contacts
Media
Sarah Connors
Vice President, Communications and Patient Advocacy, CG Oncology
sarah.connors@cgoncology.com

Investor Relations
Megan Knight
Vice President, Investor Relations, CG Oncology
megan.knight@cgoncology.com

Cogent Biosciences Announces Presentation at the 44th Annual J.P. Morgan Healthcare Conference




Cogent Biosciences Announces Presentation at the 44th Annual J.P. Morgan Healthcare Conference

WALTHAM, Mass. and BOULDER, Colo., Jan. 06, 2026 (GLOBE NEWSWIRE) — Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that Andrew Robbins, President and Chief Executive Officer, will present at the 44^th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, 2026 at 8:15 a.m. PT/11:15 a.m. ET.

A live webcast will be available on the Investors & Media page of Cogent’s website at investors.cogentbio.com. A replay of the webcast will be available approximately two hours after the completion of the event and will be archived for up to 30 days.

About Cogent Biosciences, Inc.
Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2/3 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα, KRAS and JAK2. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X.

Contact:
Christi Waarich
Senior Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653

Oculis Announces U.S. FDA Breakthrough Therapy Designation Granted to Privosegtor for Treatment of Optic Neuritis




Oculis Announces U.S. FDA Breakthrough Therapy Designation Granted to Privosegtor for Treatment of Optic Neuritis

ZUG, Switzerland, Jan. 06, 2026 (GLOBE NEWSWIRE) —

• Breakthrough Therapy Designation granted to Privosegtor, a neuroprotective candidate, for the treatment of optic neuritis

• Privosegtor is advancing in the registrational PIONEER program across 2 key optic neuropathies, representing an unaddressed potential market of $7 billion in the U.S.

• Privosegtor achieved an average gain in Low Contrast Visual Acuity (LCVA) of 18 letters compared to IV steroid alone at month 3 in the ACUITY trial
  

Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology, today announced that its neuroprotective candidate Privosegtor was granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for treatment of optic neuritis (ON).

Privosegtor, a novel peptoid small molecule designed to cross both the blood–brain and retinal barriers, has the potential to become the first neuroprotective therapy for optic neuropathies. These serious conditions carry a significant unmet need, because they can lead to permanent vision loss from nerve cell damage or death. There are no neuroprotective treatments currently available and together, they represent a potential market of $7 billion in the U.S. alone.

The FDA’s Breakthrough Therapy Designation for Privosegtor is supported by visual‑function results from the Phase 2 ACUITY trial in optic neuritis (ON), a rare, sight‑threatening neuro‑ophthalmic condition that is often the first clinical manifestation of multiple sclerosis. In the trial, Privosegtor delivered substantial improvement in LCVA along with consistent anatomical and biological benefits compared with placebo, reinforcing its potential as a neuroprotective treatment across both neuro‑ophthalmic and neurological diseases.

In the ACUITY trial, Privosegtor produced substantial vision improvements on the 2.5% ETDRS Low Contrast Letter Acuity chart. Patients receiving Privosegtor 3 mg/kg/day plus IV methylprednisolone gained an average of 18 letters at three months compared with placebo plus IV methylprednisolone. For context, a 15‑letter (three‑line) gain represents roughly a two‑fold improvement in visual resolution and is considered clinically meaningful for daily visual functioning.  Privosegtor also showed anatomical preservation of retinal and optic nerve structure, which are typically damaged during acute optic neuritis. Additional analyses showed reduced neurofilament release, a biomarker of decreased neuroaxonal injury seen in conditions such as multiple sclerosis. The most common drug‑related adverse events (AEs) were headache and acne (each in two participants; 10.5%). No drug‑related serious AEs or AEs leading to treatment or study discontinuations occurred.

Following a successful meeting with the FDA in 2025, Oculis launched the PIONEER program, which includes three pivotal trials to support registration plans for Privosegtor in ON and a second rare neuro-ophthalmic disease, NAION. These two optic neuropathies represent a potential market opportunity of potentially exceeding $7 billion in the U.S. alone, given the significant unmet medical need. The first trial in the program, PIONEER‑1 in ON, was initiated in Q4 last year. This global study spans three continents. Sites activation is underway, and enrollment is expected to begin shortly.

Riad Sherif, M.D., Chief Executive Officer of Oculis, stated, “Today’s Breakthrough Therapy Designation underscores Privosegtor’s significant potential as a first‑of‑its‑kind neuroprotective therapy for people living with optic neuritis, and highlights our commitment to redefining what’s possible for patients suffering from neuroaxonal loss. With the ACUITY results and Privosegtor now progressing as a neuroprotective platform across key neuro‑ophthalmic diseases, Oculis is uniquely positioned to reshape the treatment landscape in areas with substantial unmet needs, and 2026 is shaping up to be a milestone‑rich year across our late‑stage portfolio.”

Mark Kupersmith, M.D., Chief Medical Advisor, Neuro-Ophthalmology, added: “The ACUITY trial delivered truly groundbreaking results, demonstrating for the first time in a single study that a drug candidate consistently improves visual function alongside anatomical and biological evidence of neuroprotective benefit. Significant unmet medical needs remain, as patients with optic neuritis—more often young women and frequently experiencing the first sign of multiple sclerosis—are still at high risk of permanent visual loss.”

-ENDS-

About Privosegtor
Privosegtor, a novel peptoid small-molecule candidate that penetrates the blood-brain and retinal barriers, has the potential to become the first neuroprotective therapy for optic neuritis (ON) and other neuro-ophthalmic diseases. Positive results from the ACUITY Phase 2 trial demonstrated Privosegtor’s neuroprotective potential through anatomical preservation of the retina and improvements in visual function after an acute episode of optic neuritis. Consistent results were observed in animal models of neuroinflammation and neurodegeneration, where Privosegtor preserved retinal ganglion cell damage and was associated with improvements in mobility (clinical function disability). Privosegtor has received Breakthrough Therapy designation from the FDA and Orphan Drug designation from both the FDA and the EMA for ON and is now entering registrational trials for this indication, as well as a registrational trial in non-arteritic anterior ischemic optic neuropathy (NAION), as part of Oculis’ PIONEER (Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research) program. In addition to its potential neuroprotective effect on the optic nerve, Privosegtor could also have wide applicability in treating other neuro-ophthalmic and neurological indications.
Privosegtor is an investigational drug and has not received regulatory approval for commercial use in any country.

About Optic Neuritis
Optic Neuritis (ON) is a rare condition characterized by an acute inflammation of the optic nerve that can lead to permanent visual impairment. It affects up to 8 in 100,000 people worldwide with a U.S. incidence estimated to be >30,000 and often represents the first sign of multiple sclerosis¹. It mainly occurs in adults between the age of 20 and 40 years and is more frequent in women (2:1)². ON is a type of neuropathy (nerve disease) that happens when acute inflammation of the optic nerve affects the signals traveling from the eyes through the brain, causing pain, vision loss and other symptoms. The cells that make up the optic nerve have a lipid protective coating called a myelin sheath, which is preferentially damaged in ON. Without myelin, the optic nerve cells can’t send signals properly and axons can be irreversibly lost. To date there is no specific therapy approved for acute optic neuritis and the unmet needs remain for therapies that can prevent vision loss after an acute episode by reducing nerve cell permanent damage or death.

About Non-arteritic Anterior Ischemic Optic Neuropathy
Non-arteritic anterior ischemic optic neuropathy (NAION) is an acute optic nerve disorder that causes permanent visual impairment in >60% of affected patients³. It is the most common cause of acute optic nerve injury in individuals over 50 years old⁴ and affects up to 10.2 per 100,000 people worldwide⁵ with a U.S. incidence estimated to be >30,000^4,6,7. In NAION, the optic nerve head region swells and there is painless sudden vision loss. The swelling eventually resolves, but the optic nerve axons and neuronal cell bodies (in the retina) are permanently lost, leading to significant irreversible visual impairment or even blindness⁸. There are no approved therapies for NAION and the unmet medical need is for therapies that preserve vision and provide neuroprotection for patients suffering from NAION.

About the ACUITY Trial Supporting Breakthrough Therapy Designation
The Phase 2 ACUITY (Acute OptiC NeUrITis of DemYelinating Origin) trial was a randomized, double-blind, placebo-controlled, multi-center trial, designed to evaluate a once-daily intravenous infusion of Privosegtor over five days compared with placebo, in patients with acute optic neuritis receiving steroids. In addition to safety, other secondary efficacy endpoints were measured to evaluate the potential of Privosegtor on neuroprotection and visual function improvement in acute optic neuritis patients. The study randomized 36 eligible patients aged between 18 to 60, with recent onset (visual loss symptoms) of unilateral acute optic neuritis with a demyelinating origin, of which 33 patients received Privosegtor 2mg or 3 mg/kg/day plus IV methylprednisolone, or placebo plus IV methylprednisolone for five days.

About Breakthrough Therapy Designation⁹
Breakthrough therapy designation is intended to expedite the review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. Approaches to demonstrating substantial improvement include the following:

• Direct comparison of the new drug to available therapy shows a much greater or more important response
• If there is no available therapy, the new drug shows a substantial and clinically meaningful effect on an important outcome when compared with a placebo or a well-documented historical control.
• The new drug added to available therapy results in a much greater or more important response compared to available therapy in a controlled study or to a well-documented historical control.
• The new drug has a substantial and clinically meaningful effect on the underlying cause of the disease, in contrast to available therapies that treat only symptoms of the disease, and preliminary clinical evidence indicates that the drug is likely to have a disease modifying effect in the long term (e.g., a sustained clinical benefit compared with a temporary clinical benefit provided by available therapies).
• The new drug reverses or inhibits disease progression, in contrast to available therapies that only provide symptomatic improvement.
• The new drug has an important safety advantage that relates to serious adverse reactions (e.g., those that may result in treatment interruption) compared with available therapies and has similar efficacy.

A breakthrough therapy designation conveys more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review. FDA will review the full data submitted to support approval of drugs designated as breakthrough therapies to determine whether the drugs are safe and effective for their intended use before they are approved for marketing.

About Oculis

Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology. Oculis’ highly differentiated late-stage clinical pipeline includes three core product candidates: Privosegtor, a breakthrough neuroprotective candidate in the PIONEER program which consists of studies intended to support registration plans for treatment in optic neuropathies like optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION), with potentially broad clinical applications in various other neuro-ophthalmic and neurological diseases; OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (DME); and Licaminlimab, a novel, topical anti-TNFα in Phase 2, which is being developed with a genotype-based approach to drive precision medicine in dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.

For more information, please visit: www.oculis.com

Oculis Contact
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com

Investor Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com

Media Relations
ICR Healthcare
Amber Fennell / David Daley / Sean Leous
oculis@icrhealthcare.com

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, the initiation, timing, progress and results of current and future clinical trials, Oculis’ research and development programs, regulatory and business strategy, including planned interactions with the FDA and potential benefits of breakthrough therapy designation; Oculis’ future development plans; the timing or likelihood of regulatory filings and approvals; statements about market opportunity, and the Company’s expected financial position and cash runway, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the U.S. Securities and Exchange Commission (SEC). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

References:

1. Martínez-Lapiscina EH, et al. (2014): Is the incidence of optic neuritis rising? Evidence from an epidemiological study in Barcelona (Spain) 2008-2012. J Neurol. 2014 Apr; 261(4): 759-767.
2. Pérez-Cambrodí RJ, Gómez-Hurtado Cubillana A, Merino-Suárez ML, Piñero-Llorens DP, Laria-Ochaita C. Optic neuritis in pediatric population: a review in current tendencies of diagnosis and management. J Optom. 2014 Jul-Sep;7(3):125-30.
3. Sing Hayreh S. (2008): Nonarteritic anterior ischemic optic neuropathy: natural history of visual outcome. Ophthalmology. 2088 Feb;115(2):298-305.
4. https://www.aao.org/eyenet/article/naion-diagnosis-and-management
5. Kupersmith, MJ et al. (2024): Ophthalmic and Systemic Factors of Acute Nonarteritic Anterior Ischemic Optic Neuropathy in the Quark207 Treatment Trial. 2024 July;131(7):790-802.
6. Hattenhauer M G et al. (1997): Incidence of nonarteritic anterior ischemic optic neuropathy. American Journal of Ophthalmology. 1997 Jan;123(1):103-7.
7. Lee M S et al. (2011): Incidence of nonarteritic anterior ischemic optic neuropathy: increased risk among diabetic patients. Ophthalmology 2011 Mar 24;118(5):959-963
8. North American Neuro-Ophthalmology Society website: https://www.nanosweb.org
9. U.S. Food and Drug Administration. “Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics, 2014”. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics

Oculis Announces U.S. FDA Breakthrough Therapy Designation Granted to Privosegtor for Treatment of Optic Neuritis




Oculis Announces U.S. FDA Breakthrough Therapy Designation Granted to Privosegtor for Treatment of Optic Neuritis

ZUG, Switzerland, Jan. 06, 2026 (GLOBE NEWSWIRE) —

• Breakthrough Therapy Designation granted to Privosegtor, a neuroprotective candidate, for the treatment of optic neuritis
• Privosegtor is advancing in the registrational PIONEER program across 2 key optic neuropathies, representing an unaddressed potential market of $7 billion in the U.S.
• Privosegtor achieved an average gain in Low Contrast Visual Acuity (LCVA) of 18 letters compared to IV steroid alone at month 3 in the ACUITY trial

ZUG, Switzerland, January 6, 2026 — Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology, today announced that its neuroprotective candidate Privosegtor was granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for treatment of optic neuritis (ON).

Privosegtor, a novel peptoid small molecule designed to cross both the blood–brain and retinal barriers, has the potential to become the first neuroprotective therapy for optic neuropathies. These serious conditions carry a significant unmet need, because they can lead to permanent vision loss from nerve cell damage or death. There are no neuroprotective treatments currently available and together, they represent a potential market of $7 billion in the U.S. alone.

The FDA’s Breakthrough Therapy Designation for Privosegtor is supported by visual‑function results from the Phase 2 ACUITY trial in optic neuritis (ON), a rare, sight‑threatening neuro‑ophthalmic condition that is often the first clinical manifestation of multiple sclerosis. In the trial, Privosegtor delivered substantial improvement in LCVA along with consistent anatomical and biological benefits compared with placebo, reinforcing its potential as a neuroprotective treatment across both neuro‑ophthalmic and neurological diseases.

In the ACUITY trial, Privosegtor produced substantial vision improvements on the 2.5% ETDRS Low Contrast Letter Acuity chart. Patients receiving Privosegtor 3 mg/kg/day plus IV methylprednisolone gained an average of 18 letters at three months compared with placebo plus IV methylprednisolone. For context, a 15‑letter (three‑line) gain represents roughly a two‑fold improvement in visual resolution and is considered clinically meaningful for daily visual functioning. Privosegtor also showed anatomical preservation of retinal and optic nerve structure, which are typically damaged during acute optic neuritis. Additional analyses showed reduced neurofilament release, a biomarker of decreased neuroaxonal injury seen in conditions such as multiple sclerosis. The most common drug‑related adverse events (AEs) were headache and acne (each in two participants; 10.5%). No drug‑related serious AEs or AEs leading to treatment or study discontinuations occurred.

Following a successful meeting with the FDA in 2025, Oculis launched the PIONEER program, which includes three pivotal trials to support registration plans for Privosegtor in ON and a second rare neuro-ophthalmic disease, NAION. These two optic neuropathies represent a potential market opportunity of potentially exceeding $7 billion in the U.S. alone, given the significant unmet medical need. The first trial in the program, PIONEER‑1 in ON, was initiated in Q4 last year. This global study spans three continents. Sites activation is underway, and enrollment is expected to begin shortly.

Riad Sherif, M.D., Chief Executive Officer of Oculis, stated, “Today’s Breakthrough Therapy Designation underscores Privosegtor’s significant potential as a first‑of‑its‑kind neuroprotective therapy for people living with optic neuritis, and highlights our commitment to redefining what’s possible for patients suffering from neuroaxonal loss. With the ACUITY results and Privosegtor now progressing as a neuroprotective platform across key neuro‑ophthalmic diseases, Oculis is uniquely positioned to reshape the treatment landscape in areas with substantial unmet needs, and 2026 is shaping up to be a milestone‑rich year across our late‑stage portfolio.”

Mark Kupersmith, M.D., Chief Medical Advisor, Neuro-Ophthalmology, added: “The ACUITY trial delivered truly groundbreaking results, demonstrating for the first time in a single study that a drug candidate consistently improves visual function alongside anatomical and biological evidence of neuroprotective benefit. Significant unmet medical needs remain, as patients with optic neuritis—more often young women and frequently experiencing the first sign of multiple sclerosis—are still at high risk of permanent visual loss.”

-ENDS-

About Privosegtor
Privosegtor, a novel peptoid small-molecule candidate that penetrates the blood-brain and retinal barriers, has the potential to become the first neuroprotective therapy for optic neuritis (ON) and other neuro-ophthalmic diseases. Positive results from the ACUITY Phase 2 trial demonstrated Privosegtor’s neuroprotective potential through anatomical preservation of the retina and improvements in visual function after an acute episode of optic neuritis. Consistent results were observed in animal models of neuroinflammation and neurodegeneration, where Privosegtor preserved retinal ganglion cell damage and was associated with improvements in mobility (clinical function disability). Privosegtor has received Breakthrough Therapy designation from the FDA and Orphan Drug designation from both the FDA and the EMA for ON and is now entering registrational trials for this indication, as well as a registrational trial in non-arteritic anterior ischemic optic neuropathy (NAION), as part of Oculis’ PIONEER (Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research) program. In addition to its potential neuroprotective effect on the optic nerve, Privosegtor could also have wide applicability in treating other neuro-ophthalmic and neurological indications.
Privosegtor is an investigational drug and has not received regulatory approval for commercial use in any country.

About Optic Neuritis
Optic Neuritis (ON) is a rare condition characterized by an acute inflammation of the optic nerve that can lead to permanent visual impairment. It affects up to 8 in 100,000 people worldwide with a U.S. incidence estimated to be >30,000 and often represents the first sign of multiple sclerosis¹. It mainly occurs in adults between the age of 20 and 40 years and is more frequent in women (2:1)². ON is a type of neuropathy (nerve disease) that happens when acute inflammation of the optic nerve affects the signals traveling from the eyes through the brain, causing pain, vision loss and other symptoms. The cells that make up the optic nerve have a lipid protective coating called a myelin sheath, which is preferentially damaged in ON. Without myelin, the optic nerve cells can’t send signals properly and axons can be irreversibly lost. To date there is no specific therapy approved for acute optic neuritis and the unmet needs remain for therapies that can prevent vision loss after an acute episode by reducing nerve cell permanent damage or death.

About Non-arteritic Anterior Ischemic Optic Neuropathy
Non-arteritic anterior ischemic optic neuropathy (NAION) is an acute optic nerve disorder that causes permanent visual impairment in >60% of affected patients³. It is the most common cause of acute optic nerve injury in individuals over 50 years old⁴ and affects up to 10.2 per 100,000 people worldwide⁵ with a U.S. incidence estimated to be >30,000^4,6,7. In NAION, the optic nerve head region swells and there is painless sudden vision loss. The swelling eventually resolves, but the optic nerve axons and neuronal cell bodies (in the retina) are permanently lost, leading to significant irreversible visual impairment or even blindness⁸. There are no approved therapies for NAION and the unmet medical need is for therapies that preserve vision and provide neuroprotection for patients suffering from NAION.

About the ACUITY Trial Supporting Breakthrough Therapy Designation
The Phase 2 ACUITY (Acute OptiC NeUrITis of DemYelinating Origin) trial was a randomized, double-blind, placebo-controlled, multi-center trial, designed to evaluate a once-daily intravenous infusion of Privosegtor over five days compared with placebo, in patients with acute optic neuritis receiving steroids. In addition to safety, other secondary efficacy endpoints were measured to evaluate the potential of Privosegtor on neuroprotection and visual function improvement in acute optic neuritis patients. The study randomized 36 eligible patients aged between 18 to 60, with recent onset (visual loss symptoms) of unilateral acute optic neuritis with a demyelinating origin, of which 33 patients received Privosegtor 2mg or 3 mg/kg/day plus IV methylprednisolone, or placebo plus IV methylprednisolone for five days.

About Breakthrough Therapy Designation⁹
Breakthrough therapy designation is intended to expedite the review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. Approaches to demonstrating substantial improvement include the following:

• Direct comparison of the new drug to available therapy shows a much greater or more important response
• If there is no available therapy, the new drug shows a substantial and clinically meaningful effect on an important outcome when compared with a placebo or a well-documented historical control.
• The new drug added to available therapy results in a much greater or more important response compared to available therapy in a controlled study or to a well-documented historical control.
• The new drug has a substantial and clinically meaningful effect on the underlying cause of the disease, in contrast to available therapies that treat only symptoms of the disease, and preliminary clinical evidence indicates that the drug is likely to have a disease modifying effect in the long term (e.g., a sustained clinical benefit compared with a temporary clinical benefit provided by available therapies).
• The new drug reverses or inhibits disease progression, in contrast to available therapies that only provide symptomatic improvement.
• The new drug has an important safety advantage that relates to serious adverse reactions (e.g., those that may result in treatment interruption) compared with available therapies and has similar efficacy.

A breakthrough therapy designation conveys more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review. FDA will review the full data submitted to support approval of drugs designated as breakthrough therapies to determine whether the drugs are safe and effective for their intended use before they are approved for marketing.

About Oculis

Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology. Oculis’ highly differentiated late-stage clinical pipeline includes three core product candidates: Privosegtor, a breakthrough neuroprotective candidate in the PIONEER program which consists of studies intended to support registration plans for treatment in optic neuropathies like optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION), with potentially broad clinical applications in various other neuro-ophthalmic and neurological diseases; OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (DME); and Licaminlimab, a novel, topical anti-TNFα in Phase 2, which is being developed with a genotype-based approach to drive precision medicine in dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.

For more information, please visit: www.oculis.com

Oculis Contact
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com

Investor Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com

Media Relations
ICR Healthcare
Amber Fennell / David Daley / Sean Leous
oculis@icrhealthcare.com

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, the initiation, timing, progress and results of current and future clinical trials, Oculis’ research and development programs, regulatory and business strategy, including planned interactions with the FDA and potential benefits of breakthrough therapy designation; Oculis’ future development plans; the timing or likelihood of regulatory filings and approvals; statements about market opportunity, and the Company’s expected financial position and cash runway, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the U.S. Securities and Exchange Commission (SEC). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

References:

1. Martínez-Lapiscina EH, et al. (2014): Is the incidence of optic neuritis rising? Evidence from an epidemiological study in Barcelona (Spain) 2008-2012. J Neurol. 2014 Apr; 261(4): 759-767.
2. Pérez-Cambrodí RJ, Gómez-Hurtado Cubillana A, Merino-Suárez ML, Piñero-Llorens DP, Laria-Ochaita C. Optic neuritis in pediatric population: a review in current tendencies of diagnosis and management. J Optom. 2014 Jul-Sep;7(3):125-30.
3. Sing Hayreh S. (2008): Nonarteritic anterior ischemic optic neuropathy: natural history of visual outcome. Ophthalmology. 2088 Feb;115(2):298-305.
4. https://www.aao.org/eyenet/article/naion-diagnosis-and-management
5. Kupersmith, MJ et al. (2024): Ophthalmic and Systemic Factors of Acute Nonarteritic Anterior Ischemic Optic Neuropathy in the Quark207 Treatment Trial. 2024 July;131(7):790-802.
6. Hattenhauer M G et al. (1997): Incidence of nonarteritic anterior ischemic optic neuropathy. American Journal of Ophthalmology. 1997 Jan;123(1):103-7.
7. Lee M S et al. (2011): Incidence of nonarteritic anterior ischemic optic neuropathy: increased risk among diabetic patients. Ophthalmology 2011 Mar 24;118(5):959-963
8. North American Neuro-Ophthalmology Society website: https://www.nanosweb.org
9. U.S. Food and Drug Administration. “Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics, 2014”. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics

Hummingbird Bioscience Announces First Patient Dosed in Phase I Clinical Trial of HMBD-501 in Advanced HER3-Expressing Solid Malignancies




Hummingbird Bioscience Announces First Patient Dosed in Phase I Clinical Trial of HMBD-501 in Advanced HER3-Expressing Solid Malignancies

• HMBD-501 is a HER3-targeted ADC with a differentiated mechanism of action, engineered by Hummingbird Bioscience for optimal safety and efficacy 

SINGAPORE, Jan. 06, 2026 (GLOBE NEWSWIRE) — Hummingbird Bioscience, a biotherapeutics company discovering and developing transformative medicines for diseases with significant unmet need, today announced that the first patient has been dosed in a Phase I clinical trial of HMBD-501 for the treatment of patients with advanced HER3-expressing solid malignancies (NCT06956690).

HMBD-501 is a next-generation HER3-targeted antibody-drug conjugate (ADC) with an exatecan payload that has been optimized for safety and efficacy. The Phase I clinical trial led by Hummingbird Bioscience is underway at multiple sites in the U.S.

“Dosing the first patient in this trial is a significant milestone for the HMBD-501 program and reflects years of research and development on HER3 by the Hummingbird Bio team. We now look forward to generating high-quality clinical data that will guide the next phases of development,” said Jerome Boyd-Kirkup, PhD, Chief Scientific Officer, Hummingbird Bioscience.

“First-patient dosing marks a meaningful step forward as we begin evaluating our investigational therapy in cancer patients. This is an important step in translating our science into a potential new therapy to treat cancer,” said Kevin N. Heller, MD, Chief Medical Officer, Hummingbird Bioscience. “We recognize the significance of this moment for patients and their families, and we look forward to working closely with investigators as the study progresses.”

Initial data from the Phase I dose escalation is expected in the second half of 2026.

About HMBD-501
Multiple HER3-positive tumor settings have demonstrated response to HER3-ADC therapeutic approaches. HMBD-501 has been generated by combining Hummingbird Bioscience’s antibody discovery and engineering platform and state-of-the-art ADC technologies to enable a potentially enhanced efficacy and safety profile compared to previous generation ADCs. With key proprietary technologies enabling a differentiated molecule, HMBD-501 is poised to become a best-in-class HER3-targeted ADC.

About Hummingbird Bioscience

Hummingbird Bioscience is a biotherapeutics company working at the interface of artificial intelligence and human innovation to discover and develop transformative medicines for hard-to-treat diseases. Hummingbird Bioscience’s computational and systems biology technologies have generated a pipeline of innovative clinical-stage monoclonal antibodies and antibody-drug conjugates in oncology and autoimmunity. At Hummingbird Bioscience, the commitment to rigorous science, teamwork, and intellectual integrity underpins our passion to accelerate the journey of new drugs from concept to clinic. For more information, please visit www.hummingbirdbioscience.com, and follow Hummingbird Bioscience on LinkedIn, X (formerly Twitter), and YouTube.

Hummingbird Bioscience Media Contact:

Crystal Ho
c.ho@hummingbirdbio.com
media@hummingbirdbio.com
+65 6979 5580

Hummingbird Bioscience Investor Contact:

investors@hummingbirdbio.com

SurgiBox Inc. Appoints Kelly Laurel as Chief Executive Officer




SurgiBox Inc. Appoints Kelly Laurel as Chief Executive Officer

Current COO to Lead First-of-its-Kind Medical Device Company into Next Phase of Global Growth and Expansion

CAMBRIDGE, Mass., Jan. 06, 2026 (GLOBE NEWSWIRE) — SurgiBox Inc., the medical technology company transforming surgical care with its award-winning SurgiField™ portable surgical environment system, announces the appointment of Kelly Laurel as President and Chief Executive Officer, effective January 1, 2026. Laurel, who has served as the company’s Chief Operating Officer for the past year, will succeed co-founder Dr Mike Teodorescu, DBA who is stepping down as CEO to focus on his academic work and additional research endeavors while continuing to advise SurgiBox as a Board Member.

Laurel brings over 35 years of leadership experience including over 24 years of military service, and 12 years of healthcare innovation, and business development. She holds a Bachelor of Science in Microbiology and Chemistry, an MBA, and has completed postgraduate studies in Healthcare Policy and Management.

As a retired U.S. Army Lieutenant Colonel and former Senior Advisor to the U.S. Secretary of the Army, she has deep expertise in healthcare operations, business strategy, federal procurement, and innovative technology deployment. Her distinguished military career includes serving as a strategist on the Secretary of the Army’s personal staff, Senior Congressional Appropriations Liaison, Health Financial Policy Advisor to the Army Surgeon General, and as a Military Hospital CFO in Europe.

After retiring from the U.S. Army, Laurel joined Siemens as the Director for Federal Healthcare responsible for establishing new go-to-market strategies that achieved unprecedented market growth year over year. She later transferred to the Siemens Energy and Infrastructure Division to revitalize partnerships, address unique governmental energy and infrastructure issues, and deliver creative new solutions that yielded the highest company sales on a contract in history. After leaving Siemens, Laurel consulted for a pharmaceutical company and two energy companies charged with developing their strategic planning, capital raising, and creating key partnerships.

Laurel joined SurgiBox as its Business Development Director in 2021 and was promoted to COO in 2024. She has been instrumental in establishing the company’s global commercial infrastructure, building distributor partnerships across 20 countries and securing initial sales in 16 countries, including recent sales to the public sector in Malaysia and a private hospital in Japan. Her strategic vision has positioned the company for significant revenue growth in global markets in 2026.

“I am honored to lead SurgiBox as we enter this pivotal phase of growth,” said Kelly Laurel. “Our mission to make safe surgery accessible any time, any place has never been more important. In 2026, we will focus on delivering proven clinical outcomes, securing anchor sales across our international distributor network, and raising capital to scale our operations. The SurgiField System addresses a critical global need, and I’m excited to work with our exceptional and dedicated team to bring this life-saving technology to the patients and providers who need it most.”

Dr. Sam Goldberger, Board Member and Managing Partner of Ambit Health Ventures, praised Laurel’s appointment: “Kelly has been the driving force behind SurgiBox’s commercial strategy and international expansion. Her proven ability to build distributor relationships, oversee the company’s finances with careful precision and execute on strategic priorities makes her the ideal leader for this next chapter. Combined with her military leadership experience and deep understanding of both government and commercial healthcare markets, Kelly brings a unique skill set that will accelerate our mission to democratize access to safe surgery worldwide.”

Founded by Harvard Medical School-educated clinicians and incubated at MIT D-Lab, SurgiBox Inc. is committed to addressing the global crisis of surgical access, which affects an estimated 5 billion people worldwide. Its flagship SurgiField™ system is an ultra-portable, battery-powered solution that creates operating room-quality clean surgical environments in any setting.

The System has received numerous accolades, including recognition as a TIME Best Invention of 2023, and holds CE Mark certification under EU MDR, ISO 13485 compliance, and regulatory approvals in Japan and Türkiye, with pending approvals in Taiwan, UAE, and Saudi Arabia. Recent use cases include trauma surgeries in active war zones, an elective procedure in a hotel, and a medically-necessary procedure in a remote tent where the patient could not reach a hospital.

About SurgiBox Inc.

SurgiBox Inc. is a Cambridge, Massachusetts-based medical technology company dedicated to making safe surgery accessible any time, any place. The company’s flagship SurgiField™ system is an ultra-portable, battery-powered solution that enables safe, clean surgical conditions in diverse settings, from private clinics to the most austere disaster and conflict zones. Built on years of research and collaboration with leading clinicians, SurgiField integrates seamlessly into existing surgical workflows and meets the highest regulatory standards. For more information, visit www.surgibox.com.

Media Contact:
press@surgibox.com

MindRank Initiates Phase III “MOBILE” Trial for MDR-001: an Oral GLP-1RA Small Molecule Engineered with AI




MindRank Initiates Phase III “MOBILE” Trial for MDR-001: an Oral GLP-1RA Small Molecule Engineered with AI

• MDR-001 progressed from program discovery to Phase III in just 4.5 years, much faster than traditional development cycles.
• Phase IIb data demonstrated 10.3% mean weight reduction at Week 24 with a best-in-class safety potential (0.8% TEAE-related discontinuation rate).
• MDR-001’s unique biased-selective mechanism and metabolic benefits beyond weight loss.

HANGZHOU, China, Jan. 06, 2026 (GLOBE NEWSWIRE) — MindRank, a clinical-stage artificial intelligence (AI)-empowered drug discovery company, today announced the initiation of “MOBILE,” a pivotal Phase III clinical trial evaluating its lead candidate, MDR-001. MDR-001 is a proprietary, orally available GLP-1 receptor agonist (GLP-1RA) for chronic weight management, developed using the company’s Molecule Pro™ AI platform.

This milestone marks a paradigm shift in pharmaceutical development: MDR-001 is one of the first AI-designed molecules to reach Phase III, achieving this stage in just 4.5 years—validating the efficiency of MindRank’s proprietary discovery engine.

The Phase III MOBILE trial is led by Professor Linong Ji, Director of Endocrinology and Metabolism department at Peking University People’s Hospital and the Leading Principal Investigator for the MDR-001 clinical program.

“As a biased-selective GLP-1 receptor agonist, MDR-001 not only promotes cAMP messenger release when acting on the GLP-1 receptor but also selectively recruits beta-arrestin 2,” remarked Professor Linong Ji. “In the 24-week study, it demonstrated excellent weight loss efficacy while providing additional benefits in uric acid reduction and hepatic function measures improvement. The MDR-001 group showed a mean uric acid reduction of 57.7 µmol/L, and hepatic function measures improved substantially across the non-placebo population. With no heart rate increased was reported throughout the trial, we look forward to further confirming these differentiated advantages in Phase III clinical study.”

“Entering Phase III with MDR-001 is a validation of the AI-first approach to drug discovery,” said Zhangming Niu, Founder and CEO of MindRank. “By leveraging our AI computing engine, our team identified a molecule with unique biology and a safety profile faster than traditional methods allow. We are now focused on executing this pivotal trial to bring a convenient, oral weight-loss option to patients globally.”

Phase III MOBILE Trial Design
The MOBILE study serves as a pivotal study following positive Phase IIb data. It aims to enroll approximately 750 participants with overweight or obesity in China to evaluate 52-week efficacy and safety of MDR-00.

Summary of Phase IIb Results (n=317):

• Significant Efficacy: Participants achieved a mean weight reduction of 10.3% after 24 weeks of treatment.
• Favorable Safety Profile: Utilizing an 8-week rapid titration strategy, no drug-related serious adverse events (SAEs) occurred.
• Low Discontinuation: The discontinuation rate due to treatment-emergent adverse events (TEAEs) was only 0.8%.
• Cardiometabolic Improvements: Improvements were observed in hepatic function measures, waist circumference, blood pressure, lipid profiles, FPG and HbA1c, with a significant reduction in uric acid reduction.

About MindRank
MindRank is a clinical-stage AI drug discovery company that utilizes its proprietary platforms to accelerate the development of innovative small molecule drugs. The company focuses on high-impact targets in metabolic diseases and oncology.

Forward-Looking Statements
This press release contains forward-looking statements regarding the development of MDR-001. Actual results may differ based on clinical outcomes and regulatory requirements. MindRank undertakes no obligation to update these statements except as required by law.

Media Contact:

MindRank
Email: info@mindrank.ai, bd@mindrank.ai

Website: www.mindrank.ai