SynuSight Biotech, ABLi Therapeutics and XingImaging Announce Strategic Collaboration to Implement Alpha-Synuclein PET Imaging into Clinical Trials Evaluating Risvodetinib as a Disease-modifying Therapy for Parkinson’s Disease




SynuSight Biotech, ABLi Therapeutics and XingImaging Announce Strategic Collaboration to Implement Alpha-Synuclein PET Imaging into Clinical Trials Evaluating Risvodetinib as a Disease-modifying Therapy for Parkinson’s Disease

SynuSight Biotech has licensed ¹⁸F-FD4 to XingImaging and to ABLi Therapeutics to evaluate alpha-synuclein clearance from the brain in response to risvodetinib treatment

SHANGHAI and ATLANTA and NEW HAVEN, Conn., Jan. 05, 2026 (GLOBE NEWSWIRE) — SynuSight Biotech (“SynuSight”), a biotechnology company dedicated to the development of diagnostic solutions for neurodegenerative diseases and ABLi Therapeutics (“ABLi”), a biotechnology company developing disease-modifying therapeutics in Parkinson’s disease, have entered into non-exclusive clinical use license agreement that permits ABLi to utilize ¹⁸F-FD4 (“FD4”) in its trials to evaluate risvodetinib as a disease-modifying therapy for Parkinson’s disease (PD).

SynuSight pioneered the development of the alpha-synuclein aggregate-specific PET tracer FD4 to visualize alpha-synuclein pathology in human brain. As part of this licensing collaboration, SynuSight will receive an upfront payment and subsequent license-related fees from ABLi. As part of the collaboration, XingImaging will become the U.S.-based manufacturer of FD4 and marry it to the ultra-high resolution NeuroEXPLORER, a next generation dedicated brain PET imager housed at Xing’s newly established imaging facility in New Haven, CT.

ABLi will leverage the ability of FD4 to visualize alpha-synuclein pathology in the central nervous system to complement the novel blood-borne and tissue biomarkers developed by ABLi and its collaborators, establishing an integrated framework for comprehensive evaluation of the therapeutic effects of risvodetinib in PD. ABLi plans to implement FD4 in two clinical trials in 2026. The first, ABILITY-PD, plans to re-enroll the 120 participants in the Phase 2a 201 Trial completed in 4Q24 to measure the effect of risvodetinib treatment on biomarkers from brain, blood and tissue in a 12-month longitudinal biomarker study. ABILITY-PD will also collect motor, non-motor and dopamine transporter-specific functional data to evaluate how changes in biomarkers throughout the body correlate with functional outcomes in response to treatment. The second, the c-Abl inhibitor Modification of Parkinson’s Disease (CAMPD) trial, a Phase 2b/3 trial, will evaluate the efficacy of risvodetinib in a double-blind, placebo controlled trial in up to 500 participants with untreated Parkinson’s disease.

“This collaboration represents a key milestone in the global development of FD4. By integrating molecular imaging technologies with rigorously designed clinical trials and longitudinal follow-up, the partnership aims to directly interrogate the disease-modifying potential at the pathological level,” said SynuSight CEO Roger Fan.

“ABLi has been expanding its portfolio of disease-related biomarkers, with both blood-borne and tissue measures of alpha-synuclein pathology and is excited to add alpha-synuclein PET imaging to this panel to expand our understanding of the potential disease-modifying effect of risvodetinib in PD,” said Dr. Milton Werner, Chairman and Chief Executive of ABLi.

“This represents a pivotal opportunity to advance one of the most promising alpha-synuclein PET tracers in humans with the potential disease-modifying effect of risvodetinib in PD,” said Gilles Tamagnan, CEO of XingImaging.

About Risvodetinib (ABLi-148009)
Risvodetinib is a potent, selective small-molecule inhibitor of the non-receptor c-Abl kinases, designed for once-daily oral use that targets the underlying biological mechanisms driving Parkinson’s disease initiation and progression. Risvodetinib is believed to be a disease-modifying therapy that halts disease progression and reverses the functional loss arising from Parkinson’s disease inside and outside of the brain. All marketed therapeutic approaches to treat Parkinson’s help manage the symptoms of the disease, but there are currently no available treatments to slow or stop the disease’s relentless progression. Recently, risvodetinib was the first monotherapy shown to improve patient quality of life in a randomized, placebo-controlled clinical trial (NCT NCT05424276) and simultaneously reduced the underlying synuclein aggregate pathology in untreated Parkinson’s disease. Risvodetinib currently has intellectual property protection beyond 2036.

About ¹⁸F-FD4
¹⁸F-FD4 is a selective, high-affinity PET tracer developed by SynuSight to image pathogenic α-synuclein in Parkinson’s disease and related α-synucleinopathies. ¹⁸F-FD4 has demonstrated efficient blood-brain barrier penetration, a clear and stable imaging window with rapid washout, low off-target binding, and favorable safety in both preclinical studies and investigator-initiated trials at Huashan Hospital. In patients with PD and MSA, ¹⁸F-FD4 has consistently produced high-contrast signals in pathology-relevant brain regions and shown robust disease-differentiation performance (see image). In 2025, ¹⁸F‑FD4 received a $3.84 million research grant from the Michael J. Fox Foundation for Parkinson’s Research (MJFF)—the world’s largest nonprofit philanthropy of PD research—to support its U.S. clinical registration and development, underscoring the strong scientific rationale and clinical potential of this novel α-synuclein PET tracer. This funding award highlights the confidence of leading international research institutions in ¹⁸F-FD4 as a next-generation imaging biomarker, and clinical development is expected to begin in both the U.S. and China in the first quarter of 2026.

About ABLi Therapeutics
ABLi Therapeutics (“ABLi”) applies innovative medicinal chemistry and a deep understanding of disease biology to develop small molecule therapeutics that target the cause of diseases that arise from activation or dysfunction of the Abelson Tyrosine Kinases (c-Abl). Leveraging its expertise in drug design, ABLi utilizes clinically validated data of kinase inhibitors to design and develop novel product candidates with enhanced penetration into the brain, greater potency and target selectivity, and improved safety to treat diseases in which Abl kinase activation or dysfunction is implicated. The Company’s primary focus is on developing therapeutics for the treatment of neurodegenerative diseases like Parkinson’s disease and the Parkinson’s-related neurodegenerative diseases Multiple System Atrophy and Dementia with Lewy Body, that are all associated with Abl kinase activation or dysfunction. For more information visit www.ablitherapeutics.com or follow us on LinkedIn.

About XingImaging
XingImaging provides services across the pre-clinical and clinical spectrum including radioligand development and manufacturing, design and implementation of Phase 1 to Phase 4 clinical trials, and customized clinical imaging site coordination and management in multi-site imaging studies. Xing’s strong emphasis is on research using investigational radiotracers with quantitative imaging outcome measures as diagnostic tools and/or for assessing disease mechanism or progression. Xing focuses on developing radioligands as tools for human research aimed at advancing clinical neuroscience and nuclear medicine to understand the causes and develop more effective treatments for neurodegenerative disorders.

About SynuSight Biotech
SynuSight Biotech is committed to pioneering transformative diagnostic solutions for neurodegenerative diseases through cutting-edge scientific expertise and innovative technology platforms, ultimately benefiting millions of patients worldwide. SynuSight specializes in studying the misfolding and pathological aggregation of proteins such as alpha-synuclein, tau, and A-beta. By integrating cutting-edge technologies like Cryo-EM electron diffraction, helical filament imaging, and In-cell NMR spectroscopy, we have built unparalleled expertise in key neurodegenerative disease targets, unlocking new possibilities for innovative therapeutic solutions development.

Contacts:

For ABLi Therapeutics
info@ablitherapeutics.com

For XingImaging
info@xingimaging.com

For SynuSight Biotech
info@synusight.com

Investor/Media
Mike Moyer
Managing Director – LifeSci Advisors
mmoyer@lifesciadvisors.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0ebb1518-1452-44f1-9637-9e9f64f66132

The University of Notre Dame and Catalyst Pharmaceuticals Host Inaugural Catalyst Advocacy Scholars Summit (CASS)




The University of Notre Dame and Catalyst Pharmaceuticals Host Inaugural Catalyst Advocacy Scholars Summit (CASS)

Students from The University of Notre Dame Selected to Participate in a Week-long Biopharmaceutical Learning Intensive

CORAL GABLES, Fla., Jan. 05, 2026 (GLOBE NEWSWIRE) — The University of Notre Dame and Catalyst Pharmaceuticals, Inc. (“Catalyst” or “Company”) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced their inaugural Catalyst Advocacy Scholars Summit (CASS). This one-of-a-kind program was created with The University of Notre Dame’s Patient Advocacy Minor Department to provide participating students with an immersive learning experience exploring the opportunities and challenges of delivering medicine to people living with rare diseases. 

“We at Catalyst are excited about this unique program that we hope will help attract the best minds to the biopharmaceutical industry and increase patient focus across scientific degree programs,” said Rich Daly, President and CEO, Catalyst. “We look forward to welcoming 12 inspiring students selected by the university to spend time with Catalyst colleagues to get to know the people and functions that make our organization successful. In addition to the students learning about the incredible work involved in Patient Advocacy and navigating the biopharmaceutical industry, Catalyst will benefit from their fresh perspective on our current programs.”

The inaugural Catalyst Advocacy Scholars Summit will be held January 5 – 9, 2026, in Coral Gables, Fla.

About Catalyst Pharmaceuticals, Inc. 

Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX), is a biopharmaceutical company committed to improving the lives of patients with rare diseases. With a proven track record of bringing life-changing treatments to the market, we focus on in-licensing, commercializing, and developing innovative therapies. Guided by our deep commitment to patient care, we prioritize accessibility, ensuring patients receive the care they need through a comprehensive suite of support services designed to provide seamless access and ongoing assistance. Catalyst maintains a well-established U.S. presence, which remains the cornerstone of our commercial strategy, while continuously evaluating strategic opportunities to expand our global footprint. Catalyst, headquartered in Coral Gables, Fla., was recognized on the Forbes 2025 list as one of America’s Most Successful Mid-Cap Companies and on the 2025 Deloitte Technology Fast 500™ list as one of North America’s Fastest-Growing Companies.

For more information, please visit Catalyst’s website at www.catalystpharma.com.

Source: Catalyst Pharmaceuticals, Inc.

CONTACT: Investor Contact
Melissa Kendis, Catalyst Pharmaceuticals, Inc.
(305) 420-3200
IR@catalystpharma.com

Media Contact
David Schull
(858) 717-2310
david.schull@russopartnersllc.com

Stryker to announce financial results for its fourth quarter and full year 2025




Stryker to announce financial results for its fourth quarter and full year 2025

Portage, Michigan, Jan. 05, 2026 (GLOBE NEWSWIRE) — Stryker (NYSE:SYK) announced that it will report financial results for its fourth quarter and full year 2025 on Thursday, January 29, 2026.  A press release will be issued at approximately 4:05 p.m. ET and available at Stryker – Press Releases that day. The press release will include summary financial information for the company’s fourth quarter and full year that ended December 31, 2025.

Stryker will host a webcast at 4:30 p.m. ET on Thursday, January 29, 2026, to discuss its fourth quarter and full year 2025 results.  The webcast can be accessed at Stryker – Events & Presentations.  An archive of the webcast will also be available on the company’s website two hours after the live call ends.

About Stryker

Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside our customers around the world, we impact more than 150 million patients annually. More information is available at www.stryker.com.

Contacts

For investor inquiries:
Jason Beach, Vice President, Finance and Investor Relations at 269-385-2600 or jason.beach@stryker.com 

For media inquiries:
Kim Montagnino, Vice President, Chief Communications Officer at 269-385-2600 or kim.montagnino@stryker.com

OraSure Submits CT/NG Molecular Self-Test and Colli-Pee™ Urine Collection Device for FDA Review




OraSure Submits CT/NG Molecular Self-Test and Colli-Pee™ Urine Collection Device for FDA Review

BETHLEHEM, Pa., Jan. 05, 2026 (GLOBE NEWSWIRE) — OraSure Technologies, Inc. (NASDAQ: OSUR) (“OraSure” and “OTI”), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced that it submitted two separate applications at the end of 2025 to the U.S. Food and Drug Administration (FDA) for clearance of its rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) as well as its Colli-Pee™ at-home urine collection device for sexually transmitted infections (STIs).

“These submission milestones reflect meaningful progress on our innovation roadmap and bring us closer to realizing our vision of decentralizing diagnostics and connecting people to care that is more accessible, convenient, private, and personalized,” said Carrie Eglinton Manner, President and CEO of OTI. “As we look ahead to 2026, we are continuing to execute on our strategy with purpose and momentum to create value for all our stakeholders.”

OTI’s rapid self-test for CT/NG is built on the Sherlock molecular diagnostics platform and is designed to provide results in approximately 30 minutes in a disposable, over-the-counter format. The test uses a self-collected swab, and results can be read directly on the hand-held testing device without the need for an electrical connection, enhancing flexibility and convenience. OTI estimates that testing for CT/NG represents a total addressable market of more than $1.5 billion. Today, the vast majority of CT/NG tests in the U.S. are processed in centralized laboratories, creating an opportunity for meaningful market expansion through the introduction of an affordable rapid self-test.

OTI also submitted the Colli-Pee™ device, which is designed for at-home urine collection and is aligned with patient preferences for private and convenient diagnostic testing. The submission covers multiple STI indications and is being pursued in collaboration with a leading diagnostics platform provider. Receipt of clearance for the Colli-Pee™ device for these indications would be in addition to the existing Research-use Only (RUO) product and is expected to expand access to testing and further strengthen OTI’s leadership position in novel collection devices and chemistries.

About OraSure Technologies, Inc. 
OraSure Technologies, Inc. (“OraSure” and “OTI”) transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are. OTI improves access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. Together with its wholly-owned subsidiaries, DNA Genotek Inc., Sherlock Biosciences, Inc., and BioMedomics, Inc., OTI is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. OTI’s portfolio of products is sold globally to clinical laboratories, hospitals, physicians’ offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct to consumers.  For more information, please visit www.orasure.com.

Forward Looking Statements
This press release contains certain “forward-looking statements,” including with respect to products, product candidate development, regulatory submissions and authorizations and other matters. Forward-looking statements are based on current expectations of future events and are not guarantees of future performance or results. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from expectations and projections. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: uncertainty of commercial success; ability to manufacture or have manufactured products in accordance with applicable specifications, performance standards and quality requirements; uncertainty and timing of regulatory clearances or approvals; ability to comply with applicable regulatory requirements; uncertainty relating to patent protection and potential patent infringement claims; impact of competitors, competing products and technology changes and patents obtained by competitors; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; impact of negative economic conditions; changes in behavior and spending patterns of purchasers; and changes to applicable laws and regulations. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2024, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure undertakes no duty to update these statements.

Krystal Biotech to Present at 44th Annual J.P. Morgan Healthcare Conference




Krystal Biotech to Present at 44th Annual J.P. Morgan Healthcare Conference

PITTSBURGH, Jan. 05, 2026 (GLOBE NEWSWIRE) — Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that the Company will participate in the 44^th Annual J.P. Morgan Healthcare Conference on January 12, 2026, in San Francisco. Krish S. Krishnan, Chairman and Chief Executive Officer, is scheduled to give a presentation at 10:30 am ET / 7:30 am PT and host investor meetings throughout the day.

A webcast of the presentation will be available here beginning at 10:30 am ET / 7:30 am PT on Monday, January 12, 2026 and will be posted on the Investors section of the Company’s website.

About Krystal Biotech, Inc.

Krystal Biotech, Inc. (NASDAQ: KRYS) is a fully integrated, commercial-stage, global biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs. VYJUVEK^®, the Company’s first commercial product, is the first-ever redosable gene therapy and the first genetic medicine approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines in respiratory, oncology, dermatology, ophthalmology, and aesthetics. Krystal Biotech is headquartered in Pittsburgh, Pennsylvania. For more information, please visit http://www.krystalbio.com, and follow @KrystalBiotech on LinkedIn and X (formerly Twitter).

CONTACT
Investors and Media:                                                                                        
Stéphane Paquette
Krystal Biotech
spaquette@krystalbio.com                                                                                   

Hyperion DeFi Appoints Hyunsu Jung as Chief Executive Officer




Hyperion DeFi Appoints Hyunsu Jung as Chief Executive Officer

Board Confirms Leadership Team to Execute 2026 Strategic Priorities

Company Also Appoints Robert Rubenstein as General Counsel

LAGUNA HILLS, Calif., Jan. 05, 2026 (GLOBE NEWSWIRE) — Hyperion DeFi, Inc. (NASDAQ: HYPD) (“Hyperion DeFi” or the “Company”) today announced that its Board of Directors has appointed Hyunsu Jung as Chief Executive Officer, effective immediately.

Mr. Jung’s appointment marks an important milestone in the Company’s leadership evolution as it advances its strategic priorities for 2026. Mr. Jung joined Hyperion DeFi as Chief Investment Officer in June 2025, where he has focused on developing on-chain business lines, strengthening operational discipline, and expanding institutional relationships.

Prior to joining the Company, Mr. Jung designed and deployed differentiated digital asset strategies at DARMA Capital, a $1B+ asset manager registered with the CFTC and NFA. His work included optimizing on-chain utility across leading digital assets such as Ethereum and Filecoin, with a focus on scalable, revenue-generating strategies.

The Company also previously announced the appointment of David Knox, CFA, as Chief Financial Officer on September 29, 2025. Mr. Knox brings deep experience in capital markets and financial services, having held leadership roles at PayPal, SoFi, and Cantor Fitzgerald. As CFO, he is focused on strengthening Hyperion DeFi’s financial infrastructure and positioning the Company as a trusted bridge between traditional capital markets and decentralized finance.

“I am honored to step into the CEO role at Hyperion DeFi during this important phase for the digital asset industry,” said Mr. Jung. “Our focus is on building a leading Hyperliquid-native DeFi company that supports global adoption, monetizes growth through disciplined on-chain strategies, and provides shareholders with meaningful exposure to the expansion of the Hyperliquid ecosystem. As the market continues to prioritize fundamentals and sustainable revenue models, we believe Hyperion DeFi is well positioned to differentiate itself in 2026 and beyond.”

Rachel Jacobson, Independent Director, added:

“On behalf of the Board, we are very pleased to appoint Hyunsu Jung as CEO. He brings the right combination of leadership, strategic focus, and operational discipline to build a strong foundation for the company. The Board is fully supportive of this appointment, and together with the recent strengthening of the leadership team, we believe Hyperion DeFi is well positioned for its next phase of growth to execute its strategy and drive long-term shareholder value.”

In addition to the CEO and CFO appointments, Robert Rubenstein will be joining as General Counsel, effective January 12, 2026. Mr. Rubenstein is a seasoned legal executive with nearly three decades of experience leading legal, compliance, and business development functions for multinational public and private companies. Over his career, he has managed more than $20 billion in complex corporate transactions, overseen global regulatory compliance programs, and directed significant litigation matters in both U.S. and international jurisdictions.

About the Hyperliquid Platform and the HYPE Token

Hyperliquid is a next-generation layer one blockchain optimized for high frequency, transparent trading. The blockchain includes fully on-chain perpetual futures and spot order books, with every order, cancel, trade, and liquidation occurring within 70 millisecond block times. It also hosts the HyperEVM, a general-purpose smart contract platform that supports permissionless decentralized financial applications akin to Ethereum.

HYPE is the native token of Hyperliquid. Staked HYPE provides utility for users via reduced trading fees and increased referral bonuses. As of January 2026, more than 37 million HYPE have been autonomously purchased and sequestered by the blockchain with the trading fees generated on the network’s central limit order books.

About Hyperion DeFi, Inc.

Hyperion DeFi, Inc. is the first U.S. publicly listed company building a long-term strategic treasury of HYPE. The Company provides investors with streamlined access to the Hyperliquid ecosystem, one of the fastest growing, highest revenue-generating blockchains in the world. Shareholders benefit from compounding exposure to HYPE, both from its native staking yield and additional revenues generated from its unique on-chain utility.

Hyperion DeFi is also developing its proprietary Optejet User Filled Device that is designed to work with a variety of topical ophthalmic liquids, including artificial tears and lens rewetting products. The Optejet is especially useful in chronic front-of-the-eye diseases due to its ease of use, enhanced safety and tolerability, and potential for superior compliance versus standard eye drops. Together, these benefits may result in higher treatment compliance and better outcomes for patients and providers.

For more information, please visit Hyperiondefi.com or follow @hyperiondefi on X.

Forward Looking Statements

Except for historical information, all the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements, our future activities or other future events or conditions, including the viability of, and risks associated with, our cryptocurrency treasury strategy, the growth and revenue potential of the Hyperliquid ecosystem and the growth prospects of the Company. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission.

Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Hyperion DeFi does not undertake any obligation to update any forward-looking statements.

Certain information contained in this press release relates to or is based on studies, publications, surveys and other data obtained from third-party sources and Hyperion DeFi’s own internal estimates and research. While Hyperion DeFi believes these third-party studies, publications, surveys and other data to be reliable as of the date of this press release, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent source has evaluated the reasonableness or accuracy of Hyperion DeFi’s internal estimates or research and no reliance should be made on any information or statements made in this press release relating to or based on such internal estimates and research. You should conduct your own investigation and analysis of Hyperion DeFi, its business, prospects, results of operations and financial condition. In furnishing this information, Hyperion DeFi does not undertake any obligation to provide you with access to any additional information (including forward-looking information and any projections contained herein) or to update or correct the information.

Hyperion DeFi, Inc. Investor Contact:
Jason Assad
Hyperion DeFi, Inc.
IR@hyperiondefi.com
(678) 570-6791

TME Pharma provides update on its activities




TME Pharma provides update on its activities

TME Pharma provides update on its activities

Berlin, Germany, January 5, 2025, 08.00 CET – TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases, announced today updates on its research and development activities and its potential investment strategies.

NOX-E36 developments
TME Pharma announces the initiation of a subsequent study for NOX-E36 and the simultaneous termination of its collaboration with the Singapore Eye Research Institute (SERI) for the development of NOX-E36 for glaucoma filtration surgery, as previously announced on June 18, 2025. The end of this partnership is unrelated to the quality and potential of NOX-E36. TME Pharma is pleased to confirm its commitment to this program with the launch in January 2026 of studies to validate detection of NOX-E36 in a toxicologically relevant animal, which are the first of the studies necessary to enable local administration of NOX-E36 to patients undergoing glaucoma filtration surgery to continue advancing this promising program.

The costs of this initial study are limited, and by starting the study as planned, no further delays are necessary for follow-up studies. TME Pharma believes strongly in the potential of NOX-E36 and by starting this new program it will become easier to find a new partner to help further the research and development of this program either in collaboration with TME Pharma or through a carveout, sale, or joint venture for NOX-E36.

Fibrosis is a major contributor to glaucoma filtration surgery treatment failure and increased severity in several clinically important eye diseases with significant unmet needs, such as proliferative diabetic retinopathy and age-related macular degeneration. Collectively, these conditions affect approximately 30 million people in the US alone, with millions at risk of vision-threatening complications. This underscores the substantial market potential for innovative anti-fibrotic therapies like NOX-E36 and the interest in a future partnership for this program.

NOX-A12
TME Pharma continues its active discussions with potential partners for the NOX-A12 program. TME Pharma has kept the clinical trial for glioblastoma open so that it can be resumed as soon as a suitable partner is found. TME Pharma expects to be able to present a clear update and strategy to the market in the coming weeks.

Investment in Cryptocurrencies
On June 30, 2025, TME Pharma announced a new treasury policy to allow investment in higher-risk assets such as crypto-currency related investments. To date, no attractive opportunity has presented itself, and the Company has not invested in the crypto markets. TME Pharma has closed the year with approximately €2.0 million in cash-on-hand (as compared to €2.06 million as at June 30, 2025), reflecting a responsible treasury policy and strict cost control.

Investment in ‘GRDC’
On November 5, 2025, TME Pharma announced it had signed a non-binding LOI with a ‘German Resource Development Company’ (‘GRDC’). Discussions with this partner are still ongoing, and due diligence is underway. Only in the event that the discussions and due diligence are positive and the Company believes the transaction will create significant value, TME Pharma will submit it to the shareholders for approval.

“We have high expectations for NOX-36 and NOX-E12 and are currently considering all options. We would have liked to continue the collaboration with SERI, but we also see opportunities to develop the program with other partners. TME is pursuing alternatives and will inform the market as soon as there is concrete news about ongoing discussions about NOX-E36 and NOX-E12.” said Diede van den Ouden, CEO. “Moreover, as previously announced, I’m enthusiastic about the additional activities we are considering. Our status of being a listed company, which is structured as an holding company, is still opening up new interesting opportunities. I emphasize again that we will only present potential partnerships to shareholders that we believe could create significant shareholder value. We will act responsibly and proposals will be presented to our shareholders for approval when necessary.”

For more information, please contact:

TME Pharma N.V.
Diede van den Ouden, CEO
ir@tmepharma.com

About TME Pharma

TME Pharma is a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases. The Company’s lead compounds have been designed to act on the tumor microenvironment (TME) and the cancer immunity cycle by breaking tumor protection barriers against the immune system and blocking tumor repair. The Company’s two lead assets are:

• NOX-A12 (olaptesed pegol, an anti-CXCL12 L-RNA aptamer), which is being studied (GLORIA Phase 1/2 clinical trial) in newly-diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. The US FDA and the German BfArM have approved the design of a randomized Phase 2 trial in glioblastoma, and TME Pharma was awarded Fast Track Designation by the FDA for NOX-A12 in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer, glioblastoma. NOX-A12 in combination with radiotherapy had also previously received orphan drug designation (ODD) for glioblastoma in the United States and glioma in Europe.
• NOX-E36 (emapticap pegol, L-RNA aptamer inhibiting CCL2 and related chemokines), which is being evaluated in ophthalmic diseases with a high need for well-tolerated therapies with anti-fibrotic effect.

The Company, under the leadership of its new CEO, Diede van den Ouden, who joined in the June 2025, is currently undertaking a strategic restructuring with the goal of providing the financial resources to unlock the value of NOX-A12 and NOX-E36. These steps include:

• Raising funds from alternative sources (€1.7 million raised in May 2025, including €500,000 from the new CEO)
• Pursuing stable, cash-generating business opportunities to achieve positive operational cash flow for the Company
• Leveraging tax loss carry forwards
• Potential to gain exposure to digital assets via newly established crypto brokerage account

Further information can be found at: www.tmepharma.com.

About the GLORIA Study

GLORIA (NCT04121455) is TME Pharma’s multi-part dose-escalation, Phase 1/2 and Phase 2 study of NOX-A12 in combination with radiotherapy +/- bevacizumab (anti-VEGF) in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy).

About the OPTIMUS Study

OPTIMUS (NCT04901741) is TME Pharma’s envisaged open-label two-arm Phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients.

Disclaimer

Translations of any press release into languages other than English are intended solely as a convenience to the non-English-reading audience. The Company has attempted to provide an accurate translation of the original text in English, but due to the nuances in translating into another language, slight differences may exist. This press release includes certain disclosures that contain “forward-looking statements.” Forward-looking statements are based on TME Pharma’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in oncology drug development, including clinical trials and the timing of and TME Pharma’s ability to obtain regulatory approvals for NOX-A12 as well as any other drug candidates. Forward-looking statements contained in this announcement are made as of this date, and TME Pharma undertakes no duty to update such information except as required under applicable law.

In parallel to its core biotechnology activities, the Company is exploring potential acquisitions and partnerships in stable, profitable businesses. These efforts are aimed at creating a fundamentally profitable corporate structure in which revenues from non-core activities will support and strengthen the further development of its patented drug candidates, which remain the company’s flagship products, NOX-A12 and NOX-E36.

Attachment

• ENG_TME Pharma provides update on its activities

Nicox Announces Complete Repayment of Kreos Capital Debt and Extends Cash Runway Beyond 2027 with New Additional Financing




Nicox Announces Complete Repayment of Kreos Capital Debt and Extends Cash Runway Beyond 2027 with New Additional Financing

Press Release

Nicox Announces Complete Repayment of Kreos Capital Debt and Extends Cash Runway Beyond 2027 with New Additional Financing

• Company’s position strengthened, enabling flexibility in strategic discussions
• All Kreos Capital secured debt repaid using cash on hand
• Unsecured bond financing of up to €4 million concluded with partner and shareholder, Vester Finance
• Cash runway extended beyond 2027

January 5, 2026 – release at 7:30 am CET
Sophia Antipolis, France

Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced repayment of all secured debt and extension of its cash runway beyond 2027 with an additional unsecured financing.

“The full repayment of our debt to funds and accounts managed by Kreos Capital announced today removes a number of obligations on the Company as a result of the security interests granted over Nicox’s assets. In the last 24 months, we have demonstrated our ability to meet our timelines and fulfil our obligations, and we appreciate the support that our long-term debtholders have given us,” said Gavin Spencer, Chief Executive Officer of Nicox. “To reinforce our cash position and better manage our resources, we have taken the opportunity to continue our successful collaboration with our financing partner and shareholder, Vester Finance. Based on our current cash on hand and the current timelines, this additional financing of up to €4 million extends our cash runway beyond the end of 2027. We are now in a healthier and significantly stronger position to navigate the future, including in our strategic discussions.”

Nicox has fully repaid all outstanding debt with funds and accounts managed by Kreos Capital¹ using existing cash at 31 December 2025, thereby releasing all security guarantees over Nicox assets and terminating the right for Kreos Capital to appoint an Observer to the Board of Directors. This transaction coincides with raising new financing through the issuance of bonds to European investors, including Vester Finance, a current financing partner and established institutional investor. This financing consists of an issue of €3 million of convertible bonds and €1 million of ordinary bonds (subject to certain conditions precedent) and extends the Company’s cash runway beyond the end of 2027. This financing does not have any guarantee or security interest associated with it.

Nicox is continuing to evaluate future strategic growth opportunities, including collaborations or business combinations.

Key Future Milestones

• NCX 470 NDA submission in the United States: expected in summer 2026, based on a pre-NDA meeting, which is scheduled in Q1 2026
• NCX 470 NDA submission in China: expected shortly after submission in the U.S.
• NCX 470 Phase 3 clinical program in Japan: initiated in summer 2025. Managed and financed by Kowa.

Cash Runway

Based on the expected upcoming milestones, including the submission of an NCX 470 New Drug Application in the U.S. and a standard review period of 12 months, the financing announced today and the repayment of the Kreos Capital debt, the Company believes that its current activities are financed to beyond the end of 2027. The Company remains committed to cost control and optimizing resource allocation while maintaining the capabilities required to support our strategic objectives. If any of the assumptions around estimated income or costs change, this may impact the cash runway.

Potential proceeds from existing warrants and the €1 million additional bond financing, subject to certain conditions precedent, are not included in the above cash runway calculation.

Full Repayment of the Kreos Capital Debt

Nicox originally subscribed to a secured long-term debt with funds and accounts managed by Kreos Capital totalling €20 million in 2019. Today’s payment reimburses the remaining outstanding balance of that debt in totality. In accordance with the amendment announced on 14 October 2024, Kreos Capital retains 17 warrants giving the right to acquire 400,000 shares per warrant in Nicox at €0.25, which can be exercised until 14 October 2036.

As of 31 December 2025, Nicox’s remaining debt amounted to €0.3 million, consisting entirely of the outstanding balance of a COVID loan, which will be repaid from cash in hand by the end of August 2026.

New Bond Financing from Institutional Investors

The issuance of the convertible bonds was carried out based on the delegation granted by the Company’s shareholders during the General Meeting held on June 27, 2025, under the 13th resolution².

The convertible bonds, with a nominal unit value of €10, were subscribed at 92% of their nominal value for a total subscription price of €3,000,028.00, paid in full on the day of subscription. The bonds bear no interest and are unsecured. The bonds are convertible at any time, at a conversion price determined based on the stock market price³ at the time, in accordance with pricing rules and the ceiling set by the shareholders’ meeting.

The ordinary bonds with a nominal unit value of €9.20, have been subscribed by the same investors at 100% of their nominal value, for a total subscription price of €1,000,003.20. They do not bear any interest nor guarantees and have the same term as the convertible bonds. Their subscription price will be made as one payment, at the moment when certain conditions have been met, at the latest at the start of September 2026.

At a term of 24 months following the issuance of the debt, the bonds will be redeemed at maturity at 100% of their nominal value if they have not been converted at that date.

This transaction was advised by Vester Finance, which is also a subscriber to these bonds.

For illustrative purposes, if all convertible bonds were converted based on the Nicox share closing price on December 31, 2025, a shareholder holding 1% of the capital (calculated on the basis of the number of outstanding shares as of December 31, 2025) prior to the issuance and conversion would hold 0.876% of the capital on a non-diluted basis and 0.650% on a fully diluted basis. The new shares issued from conversion will be subject to all the provisions of the Company’s bylaws. They will be fully fungible with existing ordinary shares and will carry the same rights.

Risk Factors

Risk factors affecting the Company are detailed in section 3 of the “Rapport Annuel 2024” and in section 4 of the “Rapport semestriel 2025” which are available on Nicox’s website (www.nicox.com).

Since the conversion price of the bonds set out above is linked to the Company’s share price, the exact number of shares to be issued upon conversion cannot be determined at the time of issuance, and such conversion may significantly dilute existing shareholders.

Impact on the shareholder’s situation and on the distribution of share capital

The following table, provided for illustrative purposes only, outlines various scenarios regarding the impact of the issuance of new shares resulting from the conversion of convertible bonds on the shareholder’s situation, depending on the evolution of the share price.

*Closing price at 31 December 2025, i.e. €0.2980
**Calculated on the basis of 88,441,773 Nicox shares as of December 31, 2025

The table below presents the Company’s share capital structure before and after the conversion of the convertible bonds, based on information available to the Company, and on the assumption that all the bonds are converted at a conversion price corresponding to the closing share price as at 31 December 2025:

Prospectus – Admission to trading

The bonds will not be subject to any application for admission to trading on Euronext Growth. This issue does not give rise to the preparation of a prospectus subject to the approval of the Autorité des marchés financiers (AMF).

Termination of the PACEO⁴ Equity Financing Line

The PACEO Equity Line with Vester Finance announced on 6 March 2025 and extended on 8 August 2025 is now finished. It has permitted Nicox to raise €3.9 million, through the issuance of 15,000,000 new shares.  

About Nicox

Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health.  Nicox’s lead late-stage development program is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa in the rest of the world.  Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos.  Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories.  Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets.

Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX).

For more information www.nicox.com

Analyst coverage

H.C. Wainwright & Co Yi Chen New York, U.S.

The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.
Contacts

Nicox
Gavin Spencer
Chief Executive Officer
T +33 (0)4 97 24 53 00
communications@nicox.com

Disclaimer

The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.

Risk factors which are likely to have a material effect on Nicox’s business are presented in section 3 of the “Rapport Annuel 2024” and in section 4 of the “Rapport semestriel 2025” which are available on Nicox’s website (www.nicox.com).

Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.

Nicox S.A.
Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, France
T +33 (0)4 97 24 53 00

1 BlackRock Inc. announced the completion of its acquisition of Kreos Capital, a leading provider of growth and venture debt financing to companies in the technology and healthcare industries, on 2 August 2023.
2 Delegation of competence to the Board of Directors to increase the share capital for the benefit of a category of investors (physical or moral persons, trusts, investment funds or other financial placement vehicles; strategic partners of the Company; or all other creditors) without preferential right of subscription of the shareholders
3 At least equal to the lower of (i) €0.35 and (ii) 93.5% of the lowest of the volume-weighted average daily prices over a 2-day period preceding each conversion request
4 Capital increase program through exercise of warrants (Programme d’Augmentation de Capital par Exercice d’Options)

Attachment

• EN_NicoxDebt RepaymentJanuary2026_FINAL

Burning Rock Announces Founder’s Purchase of Its ADSs




Burning Rock Announces Founder’s Purchase of Its ADSs

GUANGZHOU, China, Jan. 05, 2026 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), a company focusing on the application of next generation sequencing (NGS) technology in the field of precision oncology, today announced that as of the date of this press release, its founder, chairman of the board of directors and chief executive officer, Mr. Yusheng Han, has purchased US$811,721.28 of the Company’s ADSs from the open market, which was conducted in compliance with the applicable rules and regulations and the Company’s insider trading policy. Mr. Han’s purchase of the Company’s ADSs indicates his confidence in the Company’s business and prospect.

Mr. Han may continue to purchase the Company’s ADSs through open-market transactions, privately negotiated transactions or block trades, or other legally permissible means, depending on market conditions and in accordance with the applicable rules and regulations. The timing and conditions of Mr. Han’s purchase will be subject to various factors, including the requirements under Rule 10b-18 and Rule 10b5-1 of the Securities Exchange Act of 1934, as well as the Company’s insider trading policy.

About Burning Rock

Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, and ii) cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.

For more information about Burning Rock, please visit: ir.brbiotech.com.

Contact: IR@brbiotech.com