ONL Therapeutics Secures $65M in Oversubscribed Series D Funding

ONL Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing innovative therapies to protect the vision of patients with retinal diseases, has announced the successful acquisition of $65 million through Series D financing. This funding round was led by Johnson & Johnson Innovation – JJDC, Inc., and included support from several other investors such as Bios Partners, Novartis Venture Fund, and Visionary Ventures.

David Esposito, the CEO of ONL Therapeutics, expressed gratitude towards both new and existing investors for enabling the company to progress towards its goal of enhancing patients' vision. The newly secured funds will allow ONL Therapeutics to advance the clinical development of their ONL1204 Ophthalmic Solution, specifically targeting geographic atrophy (GA) associated with dry age-related macular degeneration (AMD). The company plans to initiate a Phase 2 global study for this purpose.

The collaboration between ONL Therapeutics and Johnson & Johnson’s Specialty Ophthalmology research and development team continues, providing a platform for sharing insights and refining the company’s clinical development strategies.

ONL Therapeutics stands out as the sole clinical-stage company focusing on a unique mechanism of action that prevents the Fas-mediated death of retinal cells and reduces inflammatory signaling pathways. These pathways are primary contributors to vision loss and blindness. Results from a Phase 1b clinical trial of ONL1204 Ophthalmic Solution in patients with GA associated with dry AMD have shown promising outcomes. Patients treated with ONL1204 exhibited a slower progression in the growth of GA lesions when compared to untreated (sham) patients. This treatment effect was consistent regardless of whether patients received a single injection or two injections spaced 90 days apart, over a six-month period.

Co-founder and Chief Scientific Officer of ONL Therapeutics, Dr. David Zacks, highlighted the significance of this funding in continuing the groundbreaking biomedical research essential for advancing their unique clinical program targeting GA. With the novel mechanism of action of ONL1204 addressing neuroprotection, and the compelling data from their Phase 1 clinical trials, ONL Therapeutics is optimistic about introducing a new therapeutic option for GA patients globally.

The ONL1204 Ophthalmic Solution is a first-in-class small molecule inhibitor of Fas designed to protect critical retinal cells such as photoreceptors from cell death, which occurs across various retinal diseases. The root cause of vision loss and a leading cause of blindness is the death of these retinal cells through both direct and inflammatory signaling pathways. In addition to the ongoing Phase 2 study in the U.S. for treating macula-off retinal detachment—a condition for which ONL1204 has received orphan drug designation from the FDA—the company has also conducted Phase 1b clinical trials in patients with GA associated with AMD and progressing open-angle glaucoma in locations like Australia and New Zealand.

ONL Therapeutics is dedicated to developing first-in-class therapeutics aimed at protecting and enhancing the vision of patients suffering from retinal diseases. Through their pioneering technology designed to prevent Fas-mediated retinal cell death, ONL Therapeutics is at the forefront of a novel approach to vision preservation.