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




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

CAMBRIDGE, Mass., Jan. 08, 2026 (GLOBE NEWSWIRE) — Korro Bio, Inc. (Korro) (Nasdaq: KRRO) today announced that Ram Aiyar, Ph.D., Chief Executive Officer and President, will present at the 44^th Annual J.P. Morgan Healthcare Conference on Thursday, January 15, 2026, at 10:30 a.m. PT (1:30 p.m. ET). Todd Chappell, Chief Operating Officer, and Loic Vincent, Ph.D., Chief Scientific Officer, will also be participating at the conference.

A live webcast of the presentation can be accessed on the “Events & Presentations” page in the Investor section of Korro’s website at www.korrobio.com. Following the presentation, a replay of the event will be available for 30 days.

About Korro

Korro is a biopharmaceutical company focused on developing a new class of genetic medicines based on editing RNA for both rare and highly prevalent diseases. Korro is generating a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process, enabling a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro is based in Cambridge, Massachusetts. For more information, visit korrobio.com.

Korro intends to use its Investor Relations website, LinkedIn, and X (Twitter) as means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor Korro’s Investor Relations website and follow @KorroBio on LinkedIn, and X (Twitter), in addition to following Korro’s press releases, SEC filings, public conference calls, presentations, and webcasts.

Korro Bio Contact Information   

Investor & Media Contact
IR@korrobio.com

Bone Biologics Highlights 2025 Key Operational, Scientific, and Corporate Milestones and Provides 2026 Outlook




Bone Biologics Highlights 2025 Key Operational, Scientific, and Corporate Milestones and Provides 2026 Outlook

Key accomplishments include expanded rhNELL-1 shelf life, advanced NB1 development, strengthened balance sheet, and maintained Nasdaq compliance

BURLINGTON, Mass., Jan. 08, 2026 (GLOBE NEWSWIRE) — Bone Biologics Corporation (“Bone Biologics” or the “Company”) (NASDAQ: BBLG, BBLGW), a developer of orthobiologic products for spine fusion markets, today summarized key corporate, scientific, and operational milestones achieved during 2025 and outlined its strategic outlook for 2026.

“We executed with discipline throughout 2025 as we focused on strengthening the foundation required to advance our clinical program,” stated Bone Biologics CEO Jeff Frelick. “During the year, we made meaningful progress across product readiness, intellectual property, and capital structure, including extending the validated shelf life of our rhNELL-1 protein and completing financings that position us to continue advancing NB1. As we enter 2026, our goal remains the thoughtful progression of our clinical development efforts while maintaining capital discipline and creating long-term value for all our stakeholders.”

2025 Highlights
The Company focused on executing against its strategic priorities across development, operations, and corporate governance. The milestones below reflect the Company’s efforts to support ongoing program, maintain organizational stability, and position the business for future advancement.

• Extended rhNELL-1 Product Shelf Life — In December 2025, the Company announced the successful extension of the validated shelf life of its lead rhNELL-1 protein product candidate to 24 months, advancing prior 12- and 18-month stability milestones. This improvement supports manufacturing efficiency, supply-chain flexibility, and clinical readiness
• Strengthened Capital Position — Bone Biologics completed a registered public offering for total gross proceeds of $5 million during the second quarter of 2025, providing funding to support ongoing clinical development activities, intellectual property initiatives, and general corporate purposes
• Expanded Intellectual Property Portfolio — The Company filed a U.S. patent application related to its bone regeneration technology based on recombinant human NELL-1, further strengthening its proprietary platform
• Maintained Nasdaq Listing Compliance — In June 2025, Bone Biologics regained compliance with Nasdaq’s minimum bid price requirement, reinforcing its continued access to the public capital markets
• Increased Investor Engagement — Management participated in the H.C. Wainwright 27th Annual Global Investment Conference and issued a detailed stockholder letter outlining progress across the Company’s clinical and operational initiatives

Outlook for 2026
As the Company enters 2026, it plans to remain focused on advancing its clinical-stage program and strengthening its operational foundation:

• Clinical Development Progression — Continuing advancement of NB1, the Company’s rhNELL-1-based bone graft product candidate, including the expected completion of patient enrollment in its first-in-human clinical trial and potential interim updates, as appropriate
• Operational and Manufacturing Execution — Ongoing efforts to support regulatory readiness and future commercialization planning
• Intellectual Property Strategy — Continuing pursuit of relevant patent protections to enhance long-term platform value
• Financial Discipline and Strategic Focus — Maintaining prudent capital management while supporting scientific progress and shareholder engagement

About Bone Biologics
Bone Biologics was founded to pursue regenerative medicine for bone. The Company is undertaking work with select strategic partners that builds on the preclinical research of the NELL-1 protein. Bone Biologics is focusing development efforts for its bone graft substitute product on bone regeneration in spinal fusion procedures, while additionally having rights to trauma and osteoporosis applications. For more information, please visit www.bonebiologics.com.

Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements regarding the Company’s strategic outlook and expected achievements for the year 2026, timing, implementation, and success of the Company’s pilot clinical study, the Company’s development of rhNELL-1 and achievement of operational milestones, the ability of the Company’s lead product candidate NB1 to provide rapid, specific and guided control over bone regeneration and show fusion success in humans, the ability of NB1 to compete in global markets, the Company’s performance as a public company, as well as statements containing the words “anticipate,” “may,” “believe,” “continue,” “goal,” “plan,” “expect,” “outlook,” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including, but not limited to, market and other conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” 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. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Contacts

CORE IR
(212) 655-0924
investors@bonebiologics.com

EnteroBiotix announces positive Phase 2 TrIuMPH results supporting EBX-102-02 as a potential first-in-class, oral, full-spectrum microbiome therapy for irritable bowel syndrome




EnteroBiotix announces positive Phase 2 TrIuMPH results supporting EBX-102-02 as a potential first-in-class, oral, full-spectrum microbiome therapy for irritable bowel syndrome

• Clinically meaningful improvements in global IBS symptom severity observed as early as Week 1 and sustained through Week 7, with EBX-102-02 outperforming placebo throughout the study (final assessment at Week 7)
• Durable improvements observed across abdominal pain, bowel habit parameters and IBS-specific quality of life, with benefit demonstrated in both constipation and diarrhoea-predominant IBS
• EBX-102-02 was well tolerated, with no serious drug-related adverse events reported

GLASGOW, Scotland, Jan. 08, 2026 (GLOBE NEWSWIRE) — EnteroBiotix Limited (“EnteroBiotix”), a clinical-stage biopharmaceutical company focused on developing best-in-class therapies for gut health, today announced positive final results from TrIuMPH, a Phase 2a clinical trial evaluating EBX-102-02, a next-generation oral full-spectrum microbiome therapeutic, in patients with irritable bowel syndrome with constipation (IBS-C) or diarrhoea (IBS-D).

In the TrIuMPH study of 122 UK patients, EBX-102-02 demonstrated clinically meaningful improvements in the IBS symptom severity score (IBS-SSS) versus placebo, with clear separation from placebo observed as early as week 1 and sustained throughout the six-week follow up period. Benefits were observed across key assessments, including abdominal pain, bowel habit parameters, and IBS-specific quality of life. Importantly, clinically meaningful improvements in IBS-SSS that were superior to placebo were observed at all measured time points in both IBS-C and IBS-D populations, supporting the potential of EBX-102-02 as a single therapeutic approach for two major disease subtypes.

These results build on the previously reported positive topline data from the IBS-C cohort reported in March 2025 as a late-breaking oral presentation at Digestive Disease Week in San Diego. The full dataset extends the evidence base for EBX-102-02 across both IBS-C and IBS-D subtypes, supporting its development as a potential first-in-class therapeutic. EnteroBiotix plans to submit the full TrIuMPH dataset for peer-reviewed scientific publication and to initiate an IBS-C Phase 2b study in 2026, aligned with recent FDA regulatory advice.

Dr James McIlroy, CEO of EnteroBiotix, said: “The final TrIuMPH data demonstrate that EBX-102-02 has the potential to be a first-in-class, orally delivered, full-spectrum microbiome therapeutic for IBS, delivering clinically meaningful and durable improvements across multiple symptom domains in both IBS-C and IBS-D. Combined with a favourable safety profile and clear evidence of microbiome ecosystem restoration, these results strongly support advancement into our planned Phase 2b clinical trial with the goal of delivering a transformative treatment for patients with IBS.”

Mr Paul Goldsmith MD, FRCS, Consultant General Surgeon at the University of Manchester NHS Trust and Chief Investigator of the TrIuMPH study, said: “IBS is a complex disease with a significant unmet medical need. The improvements in global symptom severity, abdominal pain, bowel habits and quality of life observed with EBX-102-02 in this study are clinically meaningful. Taken together, these data support continued development of EBX-102-02 across both IBS-C and IBS-D.”

Study design

TrIuMPH was a UK-based, multicentre, randomised, double-blind, placebo-controlled Phase 2a study enrolling 122 adults with moderate-to-severe IBS, including IBS-C (n=62) and IBS-D (n=60). The study is registered as ISRCTN65517362 (“Treating IBS with an Intestinal Microbiota Product for Health”). TrIuMPH was delivered with support from the Functional Gut Clinic (FGC).

Participants were randomised 2:1 to receive EBX-102-02 (8 capsules on Day 1 and Day 7) or matched placebo and were followed for six weeks after the first dose. Study outcomes included safety and tolerability, IBS-SSS, bowel habit diaries, validated patient-reported outcome measures, and changes in gut microbiome structure and function. Post-hoc analyses included responder assessments.

Efficacy results

IBS symptom severity (IBS-SSS)

EBX-102-02 demonstrated clinically meaningful improvements (≥50-point reduction) in the IBS symptom severity score in both IBS-C and IBS-D. Improvements were observed as early as Week 1 and were sustained through Week 7, with greater reductions versus placebo at all measured timepoints.

Responder analysis (post-hoc)

Using a ≥50-point IBS-SSS reduction threshold, 59% of patients treated with EBX-102-02 were responders at Week 7 compared with 44% on placebo across the overall IBS population. Using a more stringent ≥75-point reduction threshold, responder rates were 51% versus 33%, respectively.

Key symptom domains

Improvements were observed across abdominal pain, bowel habit parameters and IBS-specific quality of life in both IBS-C and IBS-D cohorts, consistent with a broad, multi-domain therapeutic effect.

Safety and tolerability

The primary endpoint of the TrIuMPH study was safety. EBX-102-02 was generally well tolerated. Adverse events were primarily mild-to-moderate, self-limiting and gastrointestinal in nature. No severe or serious drug-related adverse events were reported, and no safety signals of concern were identified in either cohort. The safety profile was consistent with that observed in the Company’s IMPuLCE Phase 1b study in liver cirrhosis.

Microbiome analysis

Preliminary shotgun metagenomic sequencing demonstrated that EBX-102-02 induced a broad and sustained shift in the gut microbiome towards the composition of the administered product. These changes were observed in both IBS-C and IBS-D and were maintained through follow-up.

About EnteroBiotix

EnteroBiotix is a clinical-stage biopharmaceutical company developing microbiome-based therapies for gastrointestinal and metabolic diseases. Using proprietary manufacturing and analytical technologies, the Company aims to create best-in-class orally delivered products that comprehensively restore microbial ecology and function. EnteroBiotix is headquartered in Glasgow, Scotland.

About EBX-102-02

EBX-102-02 is EnteroBiotix’s next-generation full-spectrum microbiome therapeutic, manufactured using proprietary processing technologies that enable safe, stable and orally delivered microbial ecosystem restoration. It is designed to deliver consistently high microbial diversity with a robust stability profile. It is not approved in any jurisdiction for clinical therapeutic use unless in a clinical trial or regulated programme.

About the Functional Gut Clinic

The Functional Gut Clinic (FGC) is the UK’s leading provider of Functional GI Diagnostic Testing with three UK clinic sites in London, Manchester and Cambridge. FGC provides both private and NHS services to 1000’s of patients around the UK and is the only independent GI physiology clinic to have Improving Quality in Physiological Services (IQIPS) / United Kingdom Accreditation Services (UKAS) and Care Quality Commission (CQC) accreditation. Established in 2013, FGC has an extensive R&D and Clinical trials portfolio helping to design and test future digestive health tests, treatments and devices.

Media contacts

EnteroBiotix 
Dr James McIlroy, CEO
info@enterobiotix.com

Rakovina Therapeutics and Variational AI Expand Collaboration to Advance Next-Generation ATR Inhibitors




Rakovina Therapeutics and Variational AI Expand Collaboration to Advance Next-Generation ATR Inhibitors

VANCOUVER, British Columbia, Jan. 08, 2026 (GLOBE NEWSWIRE) — Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO0) (“Rakovina”), a biopharmaceutical company advancing innovative cancer therapies through AI-powered drug discovery and Variational AI, a leader in generative artificial intelligence for small-molecule design, today announced the expansion of their collaboration focused on the continued optimization of Rakovina’s kt-5000 series of ATR inhibitors.

Building on their existing collaboration, the companies have signed a new agreement to focus on lead optimization of drug candidates identified by Variational AI’s Enki™ generative AI platform and selected by Rakovina for further evaluation in the kt-5000 ATR inhibitor program. Under the expanded scope of work, Variational AI will apply its generative AI platform to iteratively optimize the initial leads with the goal of identifying a clinical candidate in months versus the industry standard of years.

Variational AI will generate and prioritize multiple optimized compound designs, while Rakovina will retain full control over which candidates to advance into laboratory testing and further development. The expanded collaboration is intended to accelerate the identification of high-quality development candidates while reducing the time and cost typically required in early-stage drug discovery.

Rakovina’s kt-5000 program comprises a series of small-molecule inhibitors targeting ATR (ataxia telangiectasia and Rad3-related), a central regulator of the DNA damage response that enables cancer cells to survive replication stress and DNA damage. ATR inhibition has emerged among big pharma companies as a promising therapeutic strategy in solid tumors, including cancers with DNA repair deficiencies such as ovarian, breast, and prostate cancer.

Rakovina recently reported results from the kt-5000 series, including compounds with dual ATR/mTOR activity and designed to achieve central nervous system (CNS) penetration at the Society for NeuroOncology annual meeting. These preclinical findings highlight efforts to address known limitations of existing ATR inhibitors and support continued optimization of the compounds.

“ATR is a proven oncology target, but real differentiation comes from optimizing the drug itself,” said Jeffrey Bacha, executive chairman of Rakovina Therapeutics. “This expanded collaboration with Variational AI enables a highly focused, AI-driven refinement of kt-5000 compounds identified for further evaluation, with particular attention to potency, selectivity, and CNS penetration. The result is a more efficient path to identifying high-quality candidates while maintaining strategic flexibility for development and partnering.”

“Our Enki™ generative AI platform efficiently explores novel chemical space and has already generated promising leads for Rakovina,” said Handol Kim, Co-Founder and CEO of Variational AI. “With this expanded collaboration, we are now applying Enki™ to exploit these novel leads through local chemical search to efficiently perform lead optimization and enable Rakovina to get to human trials faster.”

About Variational AI
Variational AI is a generative AI drug discovery company redefining the unit economics of small-molecule drug discovery and development. Based in Vancouver, Canada, Variational AI has developed Enki™, a proprietary generative AI foundation model that designs novel, optimized small-molecule drug candidates with improved potency, selectivity, and synthesizability to help partners accelerate early discovery and lead optimization. The company’s multidisciplinary team of machine learning and drug discovery experts aims to transform how transformative therapeutics are discovered by leveraging state-of-the-art generative AI. For more information, please visit www.variational.ai

About Rakovina Therapeutics Inc.
Rakovina Therapeutics is a biopharmaceutical research company focused on the development of innovative cancer treatments. Our work is based on unique technologies for targeting the DNA-damage response powered by Artificial Intelligence (AI) using the proprietary Deep-Docking™ and Enki™ platforms. By using AI, we can review and optimize drug candidates at a much greater pace than ever before.

The Company has established a pipeline of distinctive DNA-damage response inhibitors with the goal of advancing one or more drug candidates into human clinical trials in collaboration with pharmaceutical partners. Further information may be found at www.rakovinatherapeutics.com.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

Notice Regarding Rakovina Therapeutics Forward-Looking Statements:
This release includes forward-looking statements regarding the company and its respective business, which may include, but is not limited to, statements with respect to the proposed business plan of the company and other statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans,” “is expected,” “expects,” “scheduled,” “intends,” “contemplates,” “anticipates,” “believes,” “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events, or results “may,” “could,” “would,” “might,” or “will” be taken, occur, or be achieved. Such statements are based on the current expectations of the management of the company. The forward-looking events and circumstances discussed in this release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including risks regarding the biopharmaceutical industry, economic factors, regulatory factors, the equity markets generally, and risks associated with growth and competition.

Although the company has attempted to identify important factors that could cause actual actions, events, or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events, or results to differ from those anticipated, estimated, or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made, and the company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. The reader is referred to the company’s most recent filings on SEDAR+ for a more complete discussion of all applicable risk factors and their potential effects, copies of which may be accessed through the company’s profile page at www.sedar.com.

For Further Information Contact:

Oculis to Showcase Transformative Late-stage Pipeline in Neuro-ophthalmology and Ophthalmology at the 2026 J.P. Morgan Healthcare Conference




Oculis to Showcase Transformative Late-stage Pipeline in Neuro-ophthalmology and Ophthalmology at the 2026 J.P. Morgan Healthcare Conference

ZUG, Switzerland, Jan. 08, 2026 (GLOBE NEWSWIRE) —

• Breakthrough therapy designation granted as Company advances the PIONEER registrational program in optic neuropathies to create a potential market of $7B+ in the U.S. alone
• Multiple milestones anticipated from late-stage portfolio including topline results from DIAMOND Phase 3 trials with OCS-01 eye drops in diabetic macular edema (DME) expected in Q2 2026
• Riad Sherif, M.D., Chief Executive Officer, will present at the J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 1.30pm PST
  

Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in ophthalmology and neuro-ophthalmology, today announced that the transformative potential of its late-stage pipeline, including breakthrough therapy Privosegtor, the novel neuroprotective candidate in development for optic neuropathies, and novel eye drop candidate, OCS-01, for diabetic macular edema, will be highlighted in its company presentation at the upcoming 44^th Annual J.P. Morgan Healthcare Conference in San Francisco, California.

Oculis recently announced that Privosegtor, a neuroprotective candidate, has been granted breakthrough therapy designation by the U.S. FDA for the treatment of optic neuritis based on the successful ACUITY Phase 2 trial results. Privosegtor is a novel peptoid small molecule designed to cross both the blood–brain and retinal barriers and has the potential to become the first neuroprotective therapy for optic neuropathies. These serious conditions carry a significant unmet need as they can lead to permanent vision loss from nerve cell damage or death.

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

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

Oculis’s most advanced product candidate, OCS-01, is currently in Phase 3 development and aims to be the first eye drop for diabetic macular edema (DME). In the U.S. alone, the diagnosed DME population is estimated to be around 1.8 million¹ and currently represents a ~$3 billion market opportunity¹ with high unmet medical needs for early intervention and for patients with inadequate response to standard of care, which could be addressed with OCS-01 eye drops, if approved. Topline results from both DIAMOND Phase 3 trials are expected in Q2 2026 with NDA submission to the FDA planned for Q4 2026.

Riad Sherif, M.D., Chief Executive Officer of Oculis, stated “With Privosegtor advancing as a neuroprotective platform, starting with optic neuropathies as the initial focus, Oculis is uniquely positioned to transform the treatment landscape in areas with substantial unmet needs in neuro-axonal diseases, potentially creating a market exceeding $30 billion. 2026 is set to be a milestone-rich year across Oculis’ late-stage portfolio, including the much-anticipated OCS-01 DIAMOND Phase 3 trials readout in diabetic macular edema, which we look forward to in Q2 2026.”

Riad Sherif, M.D., Chief Executive Officer of Oculis, will present at the 44^th Annual J.P. Morgan Healthcare Conference as below:

Date: Wednesday, January 14, 2026
Time: 1:30pm (PST)
Venue: Westin St. Francis Hotel, 335 Powell Street, San Francisco, CA94102 (USA)

An audio webcast and replay of the presentation will be available on the J.P. Morgan website. The presentation will also be posted to the Oculis website on the Events & Presentation page under the Investors & Media section.

-ENDS-

About Privosegtor
Privosegtor, a novel peptoid small-molecule candidate that penetrates the blood-brain and retinal barriers, has the potential to become the first neuroprotective therapy for optic neuritis (ON) and other neuro-ophthalmic diseases. Positive results from the ACUITY Phase 2 trial demonstrated Privosegtor’s neuroprotective potential through anatomical preservation of the retina and improvements in visual function after an acute episode of optic neuritis. Consistent results were observed in animal models of neuroinflammation and neurodegeneration, where Privosegtor preserved retinal ganglion cell damage and was associated with improvements in mobility (clinical function disability). Privosegtor has received Breakthrough Therapy designation from the FDA and Orphan Drug designation from both the FDA and the EMA for ON and is now entering registrational trials for this indication, as well as a registrational trial in non-arteritic anterior ischemic optic neuropathy (NAION), as part of Oculis’ PIONEER (Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research) program. In addition to its potential neuroprotective effect on the optic nerve, Privosegtor could also have wide applicability in treating other neuro-ophthalmic and neurological indications.

Privosegtor is an investigational drug and has not received regulatory approval for commercial use in any country.

About Optic Neuritis
Optic Neuritis (ON) is a rare condition characterized by an acute inflammation of the optic nerve that can lead to permanent visual impairment. It affects up to 8 in 100,000 people worldwide with a U.S. incidence estimated to be >30,000 and often represents the first sign of multiple sclerosis². It mainly occurs in adults between the age of 20 and 40 years and is more frequent in women (2:1)³. ON is a type of neuropathy (nerve disease) that happens when acute inflammation of the optic nerve affects the signals traveling from the eyes through the brain, causing pain, vision loss and other symptoms. The cells that make up the optic nerve have a lipid protective coating called a myelin sheath, which is preferentially damaged in ON. Without myelin, the optic nerve cells can’t send signals properly and axons can be irreversibly lost. To date there is no specific therapy approved for acute optic neuritis and the unmet needs remain for therapies that can prevent vision loss after an acute episode by reducing nerve cell permanent damage or death.

About Non-arteritic Anterior Ischemic Optic Neuropathy
Non-arteritic anterior ischemic optic neuropathy (NAION) is an acute optic nerve disorder that causes permanent visual impairment in >60% of affected patients⁴. It is the most common cause of acute optic nerve injury in individuals over 50 years old⁵ and affects up to 10.2 per 100,000 people worldwide⁵ with a U.S. incidence estimated to be >30,000^5,7,8. In NAION, the optic nerve head region swells and there is painless sudden vision loss. The swelling eventually resolves, but the optic nerve axons and neuronal cell bodies (in the retina) are permanently lost, leading to significant irreversible visual impairment or even blindness⁹. There are no approved therapies for NAION and the unmet medical need is for therapies that preserve vision and provide neuroprotection for patients suffering from NAION.

About OCS-01 eye drops and the OPTIREACH® technology
Leveraging Oculis’ proprietary technology, OCS-01 is an OPTIREACH^® formulation of high concentration dexamethasone eye drop. It is being developed as an eye drop to treat the retina to offer a non-invasive treatment alternative for diabetic macular edema (DME). This route of administration enables easy access to treatment in the early stages of the disease and can be used in combination with other therapies in later stages. In contrast, all currently available treatments require invasive delivery methods, such as intravitreal injections or ocular implants, to reach the retina. The OPTIREACH^® solubilizing formulation technology addresses the main limitations of conventional eye drops by improving the solubility of lipophilic drugs, increasing the residence time on the eye surface and thereby, enabling the drug passage from the eye surface to the posterior segment of the eye.  Oculis’ OCS-01 is being developed with the aim to transform the current treatment paradigm in DME as a non-invasive topical treatment option.

OCS-01 is an investigational drug in Phase 3 that has not received regulatory approval for commercial use in any country.

About Diabetic Macular Edema
Diabetic Macular Edema (DME) is the leading cause of visual loss and legal blindness in patients with diabetes. Currently, it is estimated to affect around 37 million people worldwide and, with the rise of diabetes, the prevalence is expected to increase to 53 million by 2040^10,11. DME is an irreversible and progressive complication of diabetic retinopathy and is related to consistently having high blood sugar levels that damage nerves and blood vessels in the macula, the area of the retina responsible for sharp vision. DME occurs when blood vessels in the retina swell, and then leak, leading to a fluid build-up (edema) into the retina. There remains a significant need for safe, efficacious, and less burdensome treatments for DME patients.

About Oculis

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

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

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

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

Cautionary Statement Regarding Forward Looking Statements

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

References:

1. Decision Resources Group: DME – DR Landscape Forecast – Disease Landscape Forecast 2020
2. Martínez-Lapiscina EH, et al. (2014): Is the incidence of optic neuritis rising? Evidence from an epidemiological study in Barcelona (Spain) 2008-2012. J Neurol. 2014 Apr; 261(4): 759-767.
3. Pérez-Cambrodí RJ, Gómez-Hurtado Cubillana A, Merino-Suárez ML, Piñero-Llorens DP, Laria-Ochaita C. Optic neuritis in pediatric population: a review in current tendencies of diagnosis and management. J Optom. 2014 Jul-Sep;7(3):125-30.
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NRG Therapeutics Announces First Participants Dosed in its First-in-Human Phase 1 Clinical Trial of NRG5051 Which is Being Developed as a Disease-modifying Treatment for ALS/MND and Parkinson’s




NRG Therapeutics Announces First Participants Dosed in its First-in-Human Phase 1 Clinical Trial of NRG5051 Which is Being Developed as a Disease-modifying Treatment for ALS/MND and Parkinson’s

STEVENAGE, United Kingdom, Jan. 08, 2026 (GLOBE NEWSWIRE) — NRG Therapeutics Ltd. (“NRG”), a clinical stage neuroscience company targeting a novel mechanism to rectify mitochondrial dysfunction in neurodegenerative diseases, is pleased to announce that the first participants have been dosed in its first-in-human Phase 1 clinical trial of its lead candidate NRG5051 which is being developed as a treatment for amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND) and Parkinson’s.

NRG5051 is a first-in-class, orally bioavailable and CNS-penetrant next-generation inhibitor of the mitochondrial permeability transition pore (mPTP), acting through a novel undisclosed mitochondrially-localized protein regulator.

This Phase 1 randomized, double-blind trial is a combined single and multiple ascending dose trial of NRG5051 designed to assess safety, tolerability and pharmacokinetic parameters in healthy volunteers. It is being conducted at the Centre for Human Drug Research (CHDR) in Leiden, The Netherlands¹. The clinical trial is expected to readout by the end of 2026 and will inform dose selection in future studies in ALS/MND and Parkinson’s patients.

The mPTP is a well-established driver of mitochondrial dysfunction, inflammation, and neuronal death in neurodegenerative disorders. Mitochondria are crucial for energy production, especially in substantia nigra neurons (Parkinson’s) and motor neurons (ALS/MND) which have high energy demands and consequently are particularly sensitive to mitochondrial health. The pathological proteins in ALS/MND (TDP-43) and Parkinson’s (a-synuclein) are toxic to mitochondria, driving mitochondrial dysfunction which is a common underlying pathology in these diseases. NRG5051 has been shown to be neuroprotective and anti-inflammatory in in vivo preclinical models of ALS/MND and Parkinson’s.

NRG Therapeutics’ co-founder and CEO Neil Miller said, “The start of our first clinical trial marks a proud moment for NRG as we transition into a clinical stage company. Our ultimate objective is to establish the therapeutic efficacy of our novel mPTP inhibitors as disease-modifying medicines that are designed to slow or prevent the progression of neurodegenerative diseases, and this first-in-human trial is a significant step toward that goal.”

ALS/MND is a rare, rapidly progressing neurodegenerative disease with high unmet medical need. In 2023 the FDA approved Qalsody (tofersen) as a disease-modifying treatment for a rare genetic form of ALS/MND based on a biomarker (reduction in neurofilament light chain) and clinical data. However, patients with sporadic disease remain poorly treated by existing medicines. Parkinson’s is one of the fastest growing neurodegenerative conditions with a global prevalence predicted to double by 2050. There is currently no treatment available to slow or halt progression of Parkinson’s, with existing medicines providing temporary symptomatic relief only.

1. NRG5051-101 – Research into the safety of a new agent (NRG5051) in healthy adults and patients with Parkinson’s disease or ALS, EUCT number: 2025-523872-22-00, https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2025-523872-22-00]

Media enquiries (for NRG Therapeutics)
Sue Charles, Charles Consultants – +44 7968 726585 sue@charles-consultants.com

About NRG Therapeutics – https://www.nrgtherapeutics.com

NRG Therapeutics is a clinical stage neuroscience company building a pipeline of disease-modifying mitochondrial therapeutics to slow or halt the progression of neurodegenerative disorders such as amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND), and Parkinson’s.

The Company’s pipeline of small molecule assets is based on inhibiting the mitochondrial permeability transition pore (mPTP) through a novel mechanism of action. Inhibition of the mPTP has been shown to protect neurons, reduce neuroinflammation and improve motor function in pre-clinical disease models. Its lead candidate, NRG5051, is currently in a Phase 1 clinical trial.

Based at the Stevenage Bioscience Catalyst (SBC), UK, NRG Therapeutics is a private company with equity investment from Brandon Capital, British Business Bank, Criteria Bio Ventures, Dementia Discovery Fund, M Ventures, Novartis Venture Fund, Omega Funds and Parkinson’s UK. The company has also received awards from Innovate UK (Biomedical Catalyst Award), The Michael J. Fox Foundation, Target ALS and The ALS Association to support its innovative R&D programmes.

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