Catalio-Backed Rhapsogen Names Renato Skerlj, Ph.D., Chief Executive Officer




Catalio-Backed Rhapsogen Names Renato Skerlj, Ph.D., Chief Executive Officer

Dr. Skerlj brings significant drug development experience to lead biotech startup in its mission to develop next-gen autoimmune treatments

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Rhapsogen, an immunology company redefining the treatment paradigm for autoimmune diseases, today announced the appointment of Renato Skerlj, Ph.D., as the company’s new Chief Executive Officer, effective immediately.

Rhapsogen was launched by Catalio Capital Management’s venture strategy earlier this year. The company was co-founded by Prof. Jeffrey Ravetch, M.D., Ph.D., of Rockefeller University, and Prof. Eric Sundberg, Ph.D. of Emory University, both of whom are leaders in the immunology field and have made fundamental contributions to the understanding of how the immune system interacts directly with antibodies to protect against infection or cause autoimmune disease. In addition to his primary appointment, Dr. Jeffery Ravetch is a Catalio Venture Partner.

Dr. Skerlj is a seasoned biotechnology executive with more than 30 years of experience in drug discovery and development. He has authored over 70 scientific publications, is an inventor on more than 60 patents, and has played key leadership roles in advancing multiple therapeutics from discovery through clinical development and regulatory approval. Most recently, Dr. Skerlj served as President and Chief Executive Officer of Expansion Therapeutics, where he led the advancement of a proprietary RNA-targeting platform and overseeing company growth and financing. Previously, he was Co-Founder and Chief Scientific Officer of X4 Pharmaceuticals and a co-inventor of mavorixafor, which received FDA approval in 2024 for the treatment of WHIM syndrome. Across his career, Dr. Skerlj has built and led high-performing R&D organizations, contributed to successful financings and strategic transactions, and helped translate scientific innovation into impactful medicines.

“I am very excited by what we are building at Rhapsogen and look forward to working with our world-class team of immunology experts to deliver the solutions that autoimmune patients need and deserve,” said Dr. Skerlj.

“Dr. Skerlj’s leadership experience coupled with his deep drug development expertise make him well suited to maximize the potential of Rhapsogen’s first-in-class approach in autoimmune disease. We are thrilled to continue supporting the company’s growth under Dr. Skerlj’s leadership,” said Matthew Hobson, Ph.D., Principal at Catalio Capital Management, who will be also joining Rhapsogen’s Board of Directors.

About Rhapsogen

Rhapsogen is a Cambridge, MA-based immunology company focused on redefining the autoimmune treatment paradigm by developing next generation therapies that rapidly neutralize pathogenic autoantibodies and prevent autoimmune inflammation and tissue damage while preserving the immune system’s ability to fight infection. The company was founded in 2025 by Dr. Jeffrey Ravetch (Rockefeller University) and Dr. Eric Sundberg (Emory University).

To learn more, please visit www.rhapsogen.com.

About Catalio Capital Management, LP:

Catalio Capital Management, LP, is a New York-based investment firm focused on the full lifecycle of innovative healthcare investing across private, public and credit markets. Catalio has exclusive partnerships with world-renowned serial scientist-entrepreneurs from around the globe who each have extensive academic and scientific achievements and who have also started multiple well-established companies based on their research. Catalio has offices in New York, London, and Washington, D.C. Learn more about Catalio Capital Management by visiting www.cataliocapital.com.

Contacts

Media
catalio@rubenstein.com

Lysoway Therapeutics Announces Phase I Readiness of Brain-Penetrant TRPML1 Agonist LW-1017 and Nomination of a TMEM175 Development Candidate




Lysoway Therapeutics Announces Phase I Readiness of Brain-Penetrant TRPML1 Agonist LW-1017 and Nomination of a TMEM175 Development Candidate

CAMBRIDGE, Mass.–(BUSINESS WIRE)–#CNSDrugDevelopment–Lysoway Therapeutics, Inc., a biotechnology company advancing structure-guided small-molecule modulators of lysosomal ion channels to treat age-related neurodegeneration, today announced that its lead TRPML1 agonist, LW-1017, is Phase I ready. A first-in-human (FIH) study is planned in Australia, with first patient first dose (FPFD) targeted for May 2026. The Company also announced the formal nomination of a development candidate for its TMEM175 agonist program, reflecting the reproducibility of its discovery platform.

All IND-enabling studies for LW-1017 have been completed with wide safety margins, supporting the initiation of human dosing. The planned Phase I study will assess safety, tolerability, and human pharmacokinetics to inform subsequent global development.

TRPML1 is a lysosomal calcium channel that coordinates autophagy–lysosomal responses to cellular stress by promoting autophagy–lysosomal flux, lysosomal exocytosis, and activation of the transcription factors TFEB and TFE3, thereby enhancing lysosomal biogenesis and cellular clearance. Genetic, cellular, and disease-model evidence implicates impaired TRPML1 signaling in age-associated neurodegenerative processes, positioning TRPML1 as an upstream regulator of neuronal homeostasis.

In preclinical studies, LW-1017 demonstrated robust pharmacodynamic activity consistent with restoration of age-impaired autophagy–lysosomal pathway function. Oral administration achieved sustained central nervous system exposure and modulation of lysosomal and autophagy biomarkers, supporting effective target engagement in aged systems. Therapeutic relevance was demonstrated across two mechanistically related aged models of neurodegeneration. In aged Parkinson’s disease models, LW-1017 reduced pathological alpha-synuclein, preserved nigrostriatal dopaminergic integrity, and improved motor performance. In aged Alzheimer’s disease models, LW-1017 reduced amyloid and phosphorylated tau pathology, preserved neuronal integrity, and improved cognitive performance. Efficacy was observed at low oral doses, consistent with efficient brain penetration.

In parallel, Lysoway has formally nominated a development candidate for its TMEM175 agonist program. TMEM175 is supported by human genetics linking the target to Parkinson’s disease risk and lysosomal dysfunction. Nomination of a TMEM175 development candidate underscores Lysoway’s ability to reproducibly translate genetically validated, technically challenging lysosomal ion-channel targets into development-ready, brain-penetrant small molecules.

For ubiquitously expressed lysosomal ion channels, high brain exposure is essential for both efficacy and safety. TRPML1 and TMEM175 are broadly expressed in peripheral tissues, creating a narrow therapeutic window for compounds lacking sufficient central nervous system penetration. Accordingly, high brain penetration is not an advantage but a necessity. Using its structure-guided approach, Lysoway engineered agonists with brain-to-plasma AUC ratios greater than 1.5 for LW-1017 and greater than 1.0 for TMEM175 agonists in preclinical studies, supporting robust central target engagement while preserving systemic safety margins.

“Age-related decline of the autophagy–lysosomal pathway is a convergent driver of neurodegeneration, leading to toxic protein accumulation, neuroinflammation, and neuronal dysfunction across multiple diseases,” said Yongchang Qiu, PhD, Founder and Chief Executive Officer of Lysoway Therapeutics. “Lysosomal ion channels sit at key regulatory nodes of this system yet have historically been extremely difficult drug targets, particularly for CNS indications. We are proud to have overcome these challenges through a structure-guided approach that enables highly brain-penetrant agonists. LW-1017’s Phase I readiness, together with the formal nomination of a TMEM175 development candidate, demonstrates both the clinical momentum of our lead program and the reproducibility of our platform in drugging lysosomal ion channels for CNS indications.”

About Lysoway Therapeutics

Lysoway Therapeutics is a biotechnology company pioneering therapeutics targeting lysosomal ion channels to counteract age-related neurodegeneration. Leveraging structure-based drug design, high-resolution cryo-EM, and proprietary insights into lysosomal biology, Lysoway is developing highly brain-penetrant small-molecule agonists of TRPML1 and TMEM175 to restore coordinated autophagy–lysosomal function and cellular homeostasis. For more information, visit www.lysoway.com.

Forward-Looking Statements

This press release contains forward-looking statements related to planned development activities and timelines, which are subject to risks and uncertainties.

Contacts

Media contact: Info@lysoway.com

Lysoway Therapeutics Announces Phase I Readiness of Brain-Penetrant TRPML1 Agonist LW-1017 and Nomination of a TMEM175 Development Candidate




Lysoway Therapeutics Announces Phase I Readiness of Brain-Penetrant TRPML1 Agonist LW-1017 and Nomination of a TMEM175 Development Candidate

CAMBRIDGE, Mass.–(BUSINESS WIRE)–#CNSDrugDevelopment–Lysoway Therapeutics, Inc., a biotechnology company advancing structure-guided small-molecule modulators of lysosomal ion channels to treat age-related neurodegeneration, today announced that its lead TRPML1 agonist, LW-1017, is Phase I ready. A first-in-human (FIH) study is planned in Australia, with first patient first dose (FPFD) targeted for May 2026. The Company also announced the formal nomination of a development candidate for its TMEM175 agonist program, reflecting the reproducibility of its discovery platform.

All IND-enabling studies for LW-1017 have been completed with wide safety margins, supporting the initiation of human dosing. The planned Phase I study will assess safety, tolerability, and human pharmacokinetics to inform subsequent global development.

TRPML1 is a lysosomal calcium channel that coordinates autophagy–lysosomal responses to cellular stress by promoting autophagy–lysosomal flux, lysosomal exocytosis, and activation of the transcription factors TFEB and TFE3, thereby enhancing lysosomal biogenesis and cellular clearance. Genetic, cellular, and disease-model evidence implicates impaired TRPML1 signaling in age-associated neurodegenerative processes, positioning TRPML1 as an upstream regulator of neuronal homeostasis.

In preclinical studies, LW-1017 demonstrated robust pharmacodynamic activity consistent with restoration of age-impaired autophagy–lysosomal pathway function. Oral administration achieved sustained central nervous system exposure and modulation of lysosomal and autophagy biomarkers, supporting effective target engagement in aged systems. Therapeutic relevance was demonstrated across two mechanistically related aged models of neurodegeneration. In aged Parkinson’s disease models, LW-1017 reduced pathological alpha-synuclein, preserved nigrostriatal dopaminergic integrity, and improved motor performance. In aged Alzheimer’s disease models, LW-1017 reduced amyloid and phosphorylated tau pathology, preserved neuronal integrity, and improved cognitive performance. Efficacy was observed at low oral doses, consistent with efficient brain penetration.

In parallel, Lysoway has formally nominated a development candidate for its TMEM175 agonist program. TMEM175 is supported by human genetics linking the target to Parkinson’s disease risk and lysosomal dysfunction. Nomination of a TMEM175 development candidate underscores Lysoway’s ability to reproducibly translate genetically validated, technically challenging lysosomal ion-channel targets into development-ready, brain-penetrant small molecules.

For ubiquitously expressed lysosomal ion channels, high brain exposure is essential for both efficacy and safety. TRPML1 and TMEM175 are broadly expressed in peripheral tissues, creating a narrow therapeutic window for compounds lacking sufficient central nervous system penetration. Accordingly, high brain penetration is not an advantage but a necessity. Using its structure-guided approach, Lysoway engineered agonists with brain-to-plasma AUC ratios greater than 1.5 for LW-1017 and greater than 1.0 for TMEM175 agonists in preclinical studies, supporting robust central target engagement while preserving systemic safety margins.

“Age-related decline of the autophagy–lysosomal pathway is a convergent driver of neurodegeneration, leading to toxic protein accumulation, neuroinflammation, and neuronal dysfunction across multiple diseases,” said Yongchang Qiu, PhD, Founder and Chief Executive Officer of Lysoway Therapeutics. “Lysosomal ion channels sit at key regulatory nodes of this system yet have historically been extremely difficult drug targets, particularly for CNS indications. We are proud to have overcome these challenges through a structure-guided approach that enables highly brain-penetrant agonists. LW-1017’s Phase I readiness, together with the formal nomination of a TMEM175 development candidate, demonstrates both the clinical momentum of our lead program and the reproducibility of our platform in drugging lysosomal ion channels for CNS indications.”

About Lysoway Therapeutics

Lysoway Therapeutics is a biotechnology company pioneering therapeutics targeting lysosomal ion channels to counteract age-related neurodegeneration. Leveraging structure-based drug design, high-resolution cryo-EM, and proprietary insights into lysosomal biology, Lysoway is developing highly brain-penetrant small-molecule agonists of TRPML1 and TMEM175 to restore coordinated autophagy–lysosomal function and cellular homeostasis. For more information, visit www.lysoway.com.

Forward-Looking Statements

This press release contains forward-looking statements related to planned development activities and timelines, which are subject to risks and uncertainties.

Contacts

Media contact: Info@lysoway.com

1910 Publishes PEGASUS™, a Multimodal AI Model that Engineers Novel Drug-Like Macrocyclic Peptides




1910 Publishes PEGASUS™, a Multimodal AI Model that Engineers Novel Drug-Like Macrocyclic Peptides

• PEGASUS™ is an industry-first in peptide design: It achieves AI-driven generative design of the first permeable macrocyclic peptide with more than two polar or ionizable fragments.
• Surrogate assays are a breakthrough for AI model training. 1910 developed a high throughput surrogate wet lab assay that replaces the industry standard low-throughput biological assay for training PEGASUS™.
• PEGASUS™ was published as a Featured Article in the Journal of Medicinal Chemistry based on its exceptional novelty and significant scientific merit, and was hailed as a breakthrough innovation in peptide design by practitioners who are typically skeptical of AI.

BOSTON–(BUSINESS WIRE)–1910, the only AI-native biotech pioneering small and large molecule therapeutics discovery, today announced the publication of PEGASUS™, a multimodal AI model that achieves state-of-the-art accuracy in predicting and designing cell-permeable macrocyclic peptides.

As featured in the Journal of Medicinal Chemistry, PEGASUS™ generated the first reported macrocyclic peptides containing more than two polar or charged fragments that demonstrate in vitro cell permeability, addressing a longstanding barrier in peptide drug design. The publication, titled “PEGASUS: Unlocking Polarity in Cell-Permeable Cyclic Peptides Using AI Models Built on Massively Parallel Biological Assays,” is available here.

Macrocyclic peptides are a promising therapeutic class with the potential for oral bioavailability and intracellular activity, yet efforts to design them have been constrained by the intrinsic difficulty of achieving cell permeability. And although AI could help overcome this barrier, progress has been limited by a lack of permeability data: existing datasets are scarce, sparse, and biased toward hydrophobic peptides, limiting the ability of AI models to generalize beyond a narrow chemical space.

PEGASUS™ overcomes these challenges by integrating three data modalities:

• Wet-lab proxy biological data generated through 1910’s high-throughput Permeability Proxy Assay (1910 PPA™), which fractionated 2.7 billion macrocyclic peptides by hydrophobicity;
• Computational simulation data from solvent-dependent quantum mechanical models; and
• Geometric and biological embeddings that learn structural features relevant to permeability.

These combined datasets enable PEGASUS™ to learn permeability-relevant features across the full landscape of macrocyclic peptide chemistry, including regions with high polarity and charge that have historically been inaccessible to rational design. Access to this space is critical: limiting designs to low-polarity, hydrophobic peptides both increases the risk of off-target binding and in vivo toxicity, and shrinks the number of allowable peptide sequences by 96.7%, excluding peptide structures that more closely resemble existing FDA-approved therapeutics.

“In drug discovery, AI has always been constrained by the lack of large, high-quality biological datasets,” said Jen Asher, Ph.D., Founder and CEO of 1910. “PEGASUS™ closes that gap. By generating billions of experimental data points and integrating them with physics-based simulations, we built a model that expands the therapeutic possibilities for macrocyclic peptides.”

In retrospective validation, the PEGASUS™ predictive framework improved hit rates by 13.1% when used as a pre-synthesis filter, outperforming existing deep learning approaches. The integrated generative component (CycPepVAE) produced 33 macrocyclic peptides that resemble FDA-approved therapeutics in polarity and charge; among those synthesized and tested, four achieved permeability consistent with in vivo oral bioavailability – a first for peptides in this chemical regime.

“Cell permeability is essential for oral drug delivery, yet there remains limited chemical overlap between macrocyclic peptides that are routinely designed to be permeable and those that have achieved clinical success,” said Cole Baker, AI Research Scientist II at 1910 and lead author of the publication. “Our work helps bridge this gap to enable the design of orally bioavailable macrocyclic peptide therapeutics.”

Developed within 1910’s ITO™ platform, PEGASUS™ functions both as a high-accuracy predictor of permeability for large, polar macrocyclic peptides and as a generative system that designs drug-like peptide candidates with improved solubility, polarity, and charge characteristics.

The publication establishes PEGASUS™ as the most comprehensive AI system for macrocyclic peptide permeability to date and provides a blueprint for using multimodal data integration to advance new therapeutic modalities.

About 1910

1910 is the only AI-native biotech pioneering small and large molecule therapeutics discovery by integrating massive multimodal data, frontier AI models, and high-throughput lab automation into an infrastructure for AI-enabled drug discovery.

Contacts

Media Contact:
media@1910.ai

Merck to Participate in the 44th Annual J.P. Morgan Healthcare Conference




Merck to Participate in the 44th Annual J.P. Morgan Healthcare Conference

RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Robert M. Davis, chairman and chief executive officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the 44th Annual J.P. Morgan Healthcare Conference on Monday, Jan. 12, 2026, at 4:30 p.m. PST / 7:30 p.m. EST.

Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

Media Contacts:

John Cummins

john.cummins2@merck.com

Michael Levey

michael.levey@merck.com

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Steven Graziano

(732) 594-1583

Orum Therapeutics Appoints Chad May as Chief Scientific Officer to Drive Degrader-Antibody Conjugate Innovation and Programs




Orum Therapeutics Appoints Chad May as Chief Scientific Officer to Drive Degrader-Antibody Conjugate Innovation and Programs

BOSTON & DAEJEON, South Korea–(BUSINESS WIRE)–#ADC—Orum Therapeutics (Orum or the Company) (KRX: 475830), a biotechnology company pioneering the field of degrader-antibody conjugates (DACs), today announced the appointment of Chad May, Ph.D., as Chief Scientific Officer (CSO). Dr. May brings more than 20 years of oncology and immunology research experience with a track record of advancing antibody drug conjugates (ADCs), T-cell engagers, and other next-generation therapeutic platforms from concept to clinical evaluation.

“Chad has repeatedly demonstrated an ability to take bold scientific concepts and advance them into clinical candidates across multiple therapeutic modalities,” said Sung Joo (SJ) Lee, Ph.D., Founder and CEO of Orum. “His leadership experience in ADCs, T-cell engagers, and structure-driven platform design aligns with Orum’s commitment to precision engineering the next generation of degrader-antibody conjugates. Chad’s expertise strengthens our position as a leader in DAC innovation and supports our progress toward meaningful clinical milestones.”

As CSO, Dr. May will provide scientific vision and R&D leadership, guiding the strategic direction, discovery, and advancement of Orum’s pipeline, including the continued evolution of the Company’s proprietary DAC platforms and programs. He will oversee scientific strategy across discovery, translational research, and preclinical development and will play a central role in shaping the next stage of Orum’s technology innovation and pipeline growth.

“The opportunity to join Orum at this stage of growth is incredibly compelling,” said Dr. May. “The Company’s Dual-Precision Targeted Protein Degradation approach provides a powerful foundation for creating new classes of degraders guided by antibody specificity. I am excited to work closely with the talented scientific and leadership teams to advance Orum’s DAC platforms, expand therapeutic applications across cancer and other serious diseases, and drive the next wave of innovation in degrader-antibody conjugates.”

Dr. May joins Orum from Serotiny, where he served as CSO and oversaw the advancement of a novel gene and cell therapy platform through the company’s post-acquisition integration into Johnson & Johnson. Previously, he served as Senior Vice President of Research and Development at Maverick Therapeutics, where he co-founded and built the R&D organization, advanced multiple conditionally active T-cell engager programs into clinical trials, and led the company’s build-to-buy collaboration with Takeda. Earlier in his career, Dr. May held scientific leadership roles at Pfizer, where he led teams developing T-cell engagers and ADCs and advanced several programs into IND-enabling studies and clinical development. His prior work at ImClone Systems involved the design, conjugation, and evaluation of antibody-based therapeutics. Over his career, Dr. May has built and led high-performing scientific teams, contributed to numerous first-in-class program nominations, and authored more than 30 publications and patents.

About Orum’s TPD²® Approach

Orum’s unique Dual-Precision Targeted Protein Degradation (TPD²®) approach builds novel targeted protein degraders combined with the precise cell delivery mechanisms of antibodies to generate innovative, first-in-class, cell-selective TPDs for the treatment of cancer and other serious diseases. Orum has developed new targeted protein degrader payloads to specifically degrade an intracellular target protein within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, the payloads are designed to be delivered specifically to target cells and precisely degrade the intracellular target protein of interest.

About Orum Therapeutics

Orum Therapeutics is a public biotech pioneering the development of cell-specific, targeted protein degraders (TPD²®) with the precision of antibody targeting to develop the next generation of degrader antibody conjugates (DACs) for oncology and beyond. The company is advancing its GSPT1-directed TPD² programs and developing novel degrader payloads to expand the potential of targeted protein degradation. Orum’s novel targeted protein degrader payloads are designed to selectively degrade key intracellular proteins, offering a highly targeted approach to treating difficult-to-treat diseases. Orum is located in Lexington, MA, US, and Daejeon, South Korea. For more info, visit www.orumrx.com.

Orum Therapeutics Forward-Looking Statements

This press release contains forward-looking statements that are based on the current expectations and beliefs of Orum Therapeutics, Inc. (“Orum”). Statements in this release regarding matters that are not historical facts, including, but not limited to, statements relating to the development of new classes of degraders; the development of a next generation of degrader-antibody conjugates; the advancement of Orum’s pipeline, including DAC platforms and programs; the expansion of therapeutic applications; the advancement of programs to the clinical stage; and the achievement of clinical milestones are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the uncertainty of success in research and development activities; competition from alternative therapies; and risks related to the recruitment and retention of key employees, fluctuating markets and economic conditions, and future fundraising. The forward-looking statements in this presentation speak only as of the date of this release, and Orum undertakes no obligation to update or revise any of the statements. Orum cautions investors not to place considerable reliance on the forward-looking statements contained in this release.

Contacts

Corporate: IR/PR, Orum Therapeutics, media@orumrx.com
Media: Jessica Yingling, Ph.D., President, Little Dog Communications Inc., jessica@litldog.com

SINOVAC Provides Update on Antigua High Court Order and Auditor Engagement




SINOVAC Provides Update on Antigua High Court Order and Auditor Engagement

BEIJING–(BUSINESS WIRE)–Sinovac Biotech Ltd. (NASDAQ: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China, today provided an update on the Antigua High Court’s interlocutory order governing the Company’s board composition and corporate actions pending trial, and announced the engagement of Zhonghua Certified Public Accountants LLP (“Zhonghua”), an affiliate of the global accounting network UHY International, as the Company’s independent auditor and registered public accounting firm.

Update on Antigua High Court Order

Further to the order issued by the Antigua High Court (the “Court”) previously disclosed by the Company in a press release dated December 17, 2025, the Court has updated its order to provide that directors Mr. Simon Anderson, Mr. Shan Fu, Mr. Shuge Jiao, Dr. Chiang Li, Mr. Yuk Lam Lo, Mr. Yumin Qiu, Mr. Yu Wang, Ms. Rui-Ping Xiao, Mr. Andrew Y. Yan and Mr. Weidong Yin (collectively, the “Board”), will comprise the Board of the Company until the trial listed in late April/early May 2026. Ms. Rui-Ping Xiao has resigned from the Board due to personal reasons. Seven of nine of the Board members are independent and 100% of the members of the Company’s Audit, Compensation and Nominating & Corporate Governance Committees are independent.

Update on Auditor Engagement

The Company further announced that the Audit Committee of the Board approved the engagement of Zhonghua as the Company’s independent auditor effective December 31, 2025. The change was not made due to any disagreements with UHY LLP. Zhonghua is a public accounting firm registered in the People’s Republic of China and is also registered with the Public Company Accounting Oversight Board (PCAOB) in the United States. Zhonghua is a member of UHY International, one of the world’s leading accounting networks; its engagement supersedes that of UHY LLP, which is part of the same global network.

This development follows the Company’s previously announced update regarding auditor engagement and will support SINOVAC’s continued focus on its financial reporting and audit workstreams. The Company remains committed to completing the requisite audit procedures and regulatory filings as expeditiously as practicable and seeks to maintain compliance with applicable U.S. SEC and Nasdaq requirements.

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. Such statements are based upon current expectations and current market and operating conditions and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond the Company’s or Board’s control, which may cause actual results, performance or achievements to differ materially from those in the forward-looking statements. Further information regarding these and other risks, uncertainties or factors is included in the Company’s filings with the U.S. Securities and Exchange Commission. The Company and Board do not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under law.

About SINOVAC

Sinovac Biotech Ltd. (SINOVAC) is a China-based global biopharmaceutical company, with a mission of “supply vaccines to eliminate human diseases”, the company specializes in the research, development, manufacturing and commercialization of vaccines and related biological products that protect against human infectious diseases.

The company’s diversified portfolio includes vaccines for influenza, viral hepatitis, varicella, Hand-Foot-Mouth disease (HFMD), poliomyelitis, pneumococcal disease, etc., of which 3 vaccines have been prequalified by WHO, including inactivated hepatitis A vaccine Healive^®, Sabin-strain inactivated polio vaccine (sIPV), and varicella vaccine.

SINOVAC has a leading edge in developing vaccines to combat infectious disease outbreaks and was among the first to initiate R&D during major public health emergencies, including SARS, H5N1, H1N1, and COVID-19. The company developed the world’s first inactivated SARS vaccine (Phase I completed), China’s first H5N1 influenza vaccine (Panflu^®), the world’s first H1N1 influenza vaccine (Panflu.1^®), and CoronaVac^®, the most widely used inactivated COVID-19 vaccine globally.

Beyond its marketed portfolio, the company is advancing a robust pipeline that includes combination vaccines, recombinant protein vaccines and next-generation platforms such as mRNA technologies and antibodies.

With a long-standing commitment to innovation and global health, SINOVAC is expanding its global footprint by strengthening partnerships with research institutions, international organizations, and local partners. Through broader market presence, technological cooperation, and localized production, the company aims to accelerate vaccine development and supply, enhance regional access to high-quality products, and better address unmet medical needs while improving preparedness for future pandemics.

For more information, please see the Company’s website at www.sinovac.com.

Contacts

Investor and Media Contact

Sinovac Biotech Ltd.

Email: ir@sinovac.com

Sinovac Receives Nasdaq Notification Regarding Late Filing of 2025 Half-Year Report




Sinovac Receives Nasdaq Notification Regarding Late Filing of 2025 Half-Year Report

BEIJING–(BUSINESS WIRE)–Sinovac Biotech Ltd. (NASDAQ: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that it has received a notification letter dated January 2, 2026 (the “Notification Letter”) from Nasdaq Listing Qualifications (“Nasdaq”), stating that the Company was not in compliance with Nasdaq’s Listing Rule 5250(c)(2) since the Company did not timely file a Form 6-K containing an interim balance sheet and income statement as of the end of its second quarter of year 2025.

As previously disclosed, the Company received a delisting determination letter (the “Staff Determination”) from Nasdaq in November 2025. The Company requested a hearing before the Nasdaq Hearings Panel to appeal the Staff Determination on November 19, 2025. Nasdaq has informed the Company that the Nasdaq Hearings Panel will also consider the matter addressed in the Notification Letter at a hearing scheduled for January 8, 2026 at which the Company has been invited to present its views regarding this matter.

The Company is evaluating the Notification Letter and intends to present its plan and views to the Nasdaq Hearings Panel at the scheduled hearing with the objective of maintaining its Nasdaq listing.

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. Such statements are based upon current expectations and current market and operating conditions and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond the Company’s or Board’s control, which may cause actual results, performance or achievements to differ materially from those in the forward-looking statements. Further information regarding these and other risks, uncertainties or factors is included in the Company’s filings with the U.S. Securities and Exchange Commission. The Company and Board do not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under law.

About SINOVAC

Sinovac Biotech Ltd. (SINOVAC) is a China-based global biopharmaceutical company, with a mission of “supply vaccines to eliminate human diseases”, the company specializes in the research, development, manufacturing and commercialization of vaccines and related biological products that protect against human infectious diseases.

The company’s diversified portfolio includes vaccines for influenza, viral hepatitis, varicella, Hand-Foot-Mouth disease (HFMD), poliomyelitis, pneumococcal disease, etc., of which 3 vaccines have been prequalified by WHO, including inactivated hepatitis A vaccine Healive^®, Sabin-strain inactivated polio vaccine (sIPV), and varicella vaccine.

SINOVAC has a leading edge in developing vaccines to combat infectious disease outbreaks and was among the first to initiate R&D during major public health emergencies, including SARS, H5N1, H1N1, and COVID-19. The company developed the world’s first inactivated SARS vaccine (Phase I completed), China’s first H5N1 influenza vaccine (Panflu^®), the world’s first H1N1 influenza vaccine (Panflu.1^®), and CoronaVac^®, the most widely used inactivated COVID-19 vaccine globally.

Beyond its marketed portfolio, the company is advancing a robust pipeline that includes combination vaccines, recombinant protein vaccines and next-generation platforms such as mRNA technologies and antibodies.

With a long-standing commitment to innovation and global health, SINOVAC is expanding its global footprint by strengthening partnerships with research institutions, international organizations, and local partners. Through broader market presence, technological cooperation, and localized production, the company aims to accelerate vaccine development and supply, enhance regional access to high-quality products, and better address unmet medical needs while improving preparedness for future pandemics.

For more information, please see the Company’s website at www.sinovac.com.

Contacts

Investor and Media Contact

Sinovac Biotech Ltd.

Email: ir@sinovac.com

Nia Therapeutics Publishes Peer-Reviewed Validation of a 60-Channel Brain Implant for Closed-Loop Neurostimulation




Nia Therapeutics Publishes Peer-Reviewed Validation of a 60-Channel Brain Implant for Closed-Loop Neurostimulation

Wireless Smart Neurostimulation System records from 10× more brain sites than current adaptive implants; a large-animal study demonstrates chronic sensing, neural-state decoding, and programmable stimulation

ALLSTON, Mass.–(BUSINESS WIRE)–Nia Therapeutics announced publication in Brain Stimulation of the first in vivo validation of its Smart Neurostimulation System (SNS), a wireless, implantable brain-computer interface designed for closed-loop treatment of memory disorders.

The SNS records neural activity from 60 channels across four brain regions—an order-of-magnitude increase over commercially available devices. The NeuroPace RNS system, FDA-cleared for epilepsy, records from up to six channels; Medtronic’s Percept adaptive DBS system records from up to four.

This expanded sensing capacity reflects the distributed nature of memory, which arises from coordinated dynamics across widespread neural networks rather than from a single focal site.

“Most brain implants were developed for conditions in which a localized abnormal signal drives symptoms,” said Michael J. Kahana, PhD, co-founder and CEO of Nia Therapeutics and a professor at the University of Pennsylvania. “Decades of research show that memory depends on coordinated activity across distributed networks. The SNS was engineered to detect these patterns and respond with personalized stimulation.”

Preclinical Validation in Freely Moving Large Animals

In a chronic study of three sheep, the SNS demonstrated stable performance across core functions:

• Neural-state decoding. Machine-learning classifiers distinguished movement from stillness with high accuracy (AUC 0.92–0.98), with performance stable throughout implantation.
• Programmable neuromodulation. Systematic variation of stimulation parameters produced dose-dependent changes in alpha-band (8–12 Hz) and gamma-band (78–82 Hz) neural activity, confirming that stimulation reliably modulates physiological signals.
• Biocompatibility. Histological analyses showed no adverse tissue response, with findings comparable to a commercially available control lead.

These results demonstrate that the SNS can chronically record distributed neural activity, decode behaviorally relevant brain states, and deliver stimulation with predictable effects—key prerequisites for future closed-loop neurostimulation therapies.

Building on a Decade of Human Memory Research

The SNS builds on federally funded research supported by DARPA and NIH. In prior human studies using externalized research systems, Kahana and colleagues recorded intracranial brain activity from hundreds of epilepsy patients performing memory tasks and showed that machine-learning models could predict, moment by moment, whether newly learned information would be remembered.

In sham-controlled clinical experiments, brief bursts of electrical stimulation delivered during classifier-identified poor-encoding states improved delayed recall by approximately 20%; stimulation delivered at random times produced no benefit. Those studies established the therapeutic principle underlying Nia’s approach but relied on devices unsuitable for chronic use.

“This publication shows that the core capabilities required for memory-guided stimulation—high-density sensing, real-time decoding, and programmable neuromodulation—can be delivered in a fully implantable, wireless system,” said Daniel S. Rizzuto, PhD, co-founder and President of Nia Therapeutics.

Addressing an Unmet Clinical Need

Memory impairment is among the most common and disabling consequences of traumatic brain injury and age-related cognitive decline. Although recent disease-modifying drugs for early Alzheimer’s can slow progression, they do not restore lost function. Nia’s approach aims to complement such treatments by directly improving memory through targeted neuromodulation.

Nia Therapeutics is preparing for first-in-human studies, with regulatory submissions planned for 2026. The initial study will focus on patients with memory loss resulting from moderate-to-severe traumatic brain injury.

About Nia Therapeutics

Nia Therapeutics develops implantable brain-computer interfaces for memory disorders. Founded in 2018, the company’s SNS device supports closed-loop neuromodulation by detecting brain states linked to impaired memory encoding and delivering targeted stimulation. Visit www.niatx.com.

Publication Reference

Rizzuto DS, Herrema HG, Hu Z, Utin D, Kahn J, Ho C, Smiles A, Gross RE, Lega BC, Das SR, Kahana MJ. A wireless, 60-channel, AI-enabled neurostimulation platform. Brain Stimulation (2025). DOI: https://doi.org/10.1016/j.brs.2025.103013

Contacts

Media Contact
Michael Kahana, PhD, CEO, Nia Therapeutics, mike@niatx.com

Bausch + Lomb Completes Refinancing of Outstanding Term B Loans




Bausch + Lomb Completes Refinancing of Outstanding Term B Loans

VAUGHAN, Ontario–(BUSINESS WIRE)–Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb” or the “company”), a leading global eye health company dedicated to helping people see better to live better, today announced that it closed the previously announced credit agreement refinancing. In connection with the closing, Bausch + Lomb has entered into a fourth amendment (the “Fourth Amendment”) to its existing credit agreement providing for a $2,802,125,000 tranche (the “Replacement Term Loans”) of new term B loans, the proceeds of which were used to refinance all of its outstanding term B loans due 2031 (the “Third Amendment Term Loans”) and its outstanding term B loans due 2028 (the “First Incremental Term Loans”).

The amortization rate for the Replacement Term Loans is 1.00% per annum and the first installment shall be payable on June 30, 2026. Pursuant to the Fourth Amendment, the applicable margin is (i) 3.75% per annum for Replacement Term Loans with an interest rate determined by reference to term SOFR and (ii) 2.75% per annum for Replacement Term Loans with an interest rate determined by reference to the alternate base rate. The margin applicable to the Replacement Term Loans represents a 0.50% per annum reduction from the applicable margin that applied to the Third Amendment Term Loans and a 0.25% per annum reduction from the applicable margin that applied to the First Incremental Term Loans. The Replacement Term Loans will mature on January 15, 2031, which is the same maturity date that applied to the Third Amendment Term Loans and which represents an effective maturity extension of the First Incremental Term Loans from September 29, 2028.

About Bausch + Lomb

Our mission is simple – we help people see better to live better, all over the world. For nearly two centuries we’ve evolved with the changing needs of patients and customers, and our commitment to innovation and improving the standard of care in eye health has never been stronger. From contact lenses to prescription products, over-the-counter options, surgical devices and more, we’re turning bold ideas into better outcomes through passion, perseverance and purpose. Learn more at www.bausch.com and connect with us on Facebook, Instagram, LinkedIn, X and YouTube.

Forward-looking Statements

This news release may contain forward-looking information and statements within the meaning of applicable securities laws (collectively, “forward-looking statements”). Forward-looking statements may generally be identified by the use of the words “anticipates,” “seeks,” “expects,” “plans,” “should,” “could,” “would,” “may,” “will,” “believes,” “potential,” “pending” or “proposed” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb’s filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators (including the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2024 and its most recent quarterly filings). In addition, certain material factors and assumptions have been applied in making these forward-looking statements, including the assumption that the risks and uncertainties discussed in such filings will not cause actual results or events to differ materially from those described in these forward-looking statements. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

© 2026 Bausch + Lomb.

Contacts

Media Contact:

Chris Clark

chris.clark@bausch.com
(848) 360-1100

Investor Contact:

George Gadkowski

george.gadkowski@bausch.com
(877) 354-3705 (toll free)

(908) 927-0735