Breye Therapeutics raises €67.5 million in over-subscribed Series A financing

• Co-led by new investor Mission BioCapital and existing investor Novo Holdings, with additional investment from existing syndicate member Sound Bioventures, and new investors the Ljungström family office, Innovestor Life Science, EIFO, Catalyze Capital, Modi Ventures, and Pappas Capital
• Company will now advance danegaptide, a pioneering, first-in-class oral treatment for Non-Proliferative Diabetic Retinopathy (NPDR), into a Phase II clinical trial
  Funding will also be used to mature Breye’s wider pipeline of assets for retinal diseases, including its P2X7 receptor antagonist for intermediate age-related macular degeneration (iAMD)

COPENHAGEN, Denmark, Sept. 29, 2026 (GLOBE NEWSWIRE) -- Breye Therapeutics ApS (Breye), a clinical-stage biopharmaceutical company developing oral therapeutics for the early treatment of retinal diseases, today announced the successful close of an over-subscribed €67.5 million Series A financing round. The round was co-led by new investor Mission BioCapital and existing investor Novo Holdings, with participation from existing investor Sound Bioventures and additional new investors including the Ljungström family office, Innovestor Life Science, EIFO, Catalyze Capital, Modi Ventures and Pappas Capital.

The proceeds of the financing will be used to advance Breye’s lead asset danegaptide into a randomized Phase 2 clinical trial in patients with NPDR. The study, which will aim to demonstrate clinical proof-of-concept, is due to start in 2027. In conjunction with the financing, Robert Blazej, Partner at Mission BioCapital, and Lukas Ljungström from the Ljungström family office will join Breye’s board.

The financing comes shortly after Breye had an academic paper analyzing the pre-clinical and early clinical stage evidence for danegaptide published in the prestigious journal Science Translational Medicine.

Ulrik Mouritzen, Chief Executive Officer, Breye Therapeutics, said: “This €67.5m Series A financing, which includes significant support from both new and existing investors, reflects the strong confidence in Breye's vision, strategy, and pipeline. It marks a major milestone for the Company and validates the enormous progress we have made to date. Importantly, it enables us to advance danegaptide, our pioneering, first-in-class oral treatment for diabetic retinopathy, to the next stage of clinical development – bringing a much-needed patient-friendly treatment option closer to those living with this debilitating eye disease.”

Robert Blazej, Partner, Mission BioCapital, said: “Breye is emerging as a leader in the development of innovative retinal disease therapies, as demonstrated by the promising results from its recent Phase Ib study of danegaptide, and we are excited to support the Company at this pivotal stage of growth. With its highly differentiated approach, clear development strategy and experienced team, we believe Breye is uniquely positioned to address a significant unmet need in diabetic retinopathy.”

Jørgen Søberg Petersen, Senior Partner, Novo Holdings, said: “Danegaptide has the potential to address a major unmet need in diabetic retinopathy, by offering what we believe will be a highly effective, non-invasive treatment solution. Our continued investment in Breye Therapeutics reflects the strong progress the Company has made and our confidence in the team. Breye is purposefully advancing its mission of delivering innovative therapies for patients with retinal eye diseases, who have very limited treatment options, and we are very proud to continue to support the team.”

Danegaptide is a first-in-class oral small molecule with a novel mode of action that stabilizes the retinal vasculature, thus protecting against retinal capillary breakdown and vascular leakage caused by chronically high glucose levels (hyperglycemia). The financing follows the successful completion of a Phase 1b trial in patients with NPDR last year, which showed danegaptide was well tolerated across all dose levels and exhibited early signs of clinical activity, including retinal imaging data consistent with reductions in vascular leakage, one of the core pathologies of NPDR.

Diabetic retinopathy is a leading cause of vision loss among working-age adults, today affecting about 130 million people worldwide. The current market value of diabetic retinopathy therapeutics is already approaching $10 billion, a figure that is forecast to nearly double over the next decade, with a predicted CAGR of 6.5%.

While currently available intravitreal (IVT) treatments can help preserve vision in patients with late-stage disease, their invasive nature – being injected directly into the eye – means they are often poorly tolerated and associated with low continued adherence. In addition, treatment options for patients with early or moderate stage NPDR remain very limited. This significant unmet medical need, combined with a large and growing patient population, highlights the substantial market opportunity for danegaptide. An oral, non-invasive treatment solution would be complementary to existing therapies, enabling more patients to be helped around the world.

The funding will also be used to progress Breye’s broader pipeline of oral small molecules, which includes a P2X7 receptor antagonist for iAMD which is intended to reduce nerve damage and inflammation, and additional candidates in glaucoma with neuroprotective effects. These are advancing towards IND-enabling studies.

For further information:
Optimum Strategic Communications
Mary Clark, Stephen Adams, Aoife Minihan
Tel: +44 20 3821 6420
Email: [email protected]

About Breye Therapeutics
Breye Therapeutics is a clinical-stage ophthalmology focused biopharmaceutical company developing oral therapeutics for the early treatment of retinal eye diseases. Breye is developing a pipeline of oral therapies for diseases of the eye, such as intermediate age-related macular degeneration and glaucoma, so more patients can maintain their sight, autonomy, and quality of life. Its lead candidate, danegaptide, is the first oral drug designed to treat diabetic retinopathy in its earlier stages and has a novel mechanism of action designed to stop and reverse disease progression. It is currently progressing through clinical development, with Phase 1b successfully completed and a Phase 2 trial planned to demonstrate clinical proof-of-concept.

Breye is backed by Novo Holdings, Mission BioCapital, Sound BioVentures, the Ljungström family office, Innovestor Life Science, EIFO, Catalyze Capital, Modi Ventures and Pappas Capital. It has also received financial support from the BioInnovation Institute, and the Danish Innovation Foundation (Innovationsfonden).

For more information, please visit: https://breye.com

Source: Breye Therapeutics

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