ONL Therapeutics secures financing to advance lead compound into Phase 2 clinical trial

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ONL Therapeutics Inc. this week announced it has closed on the first tranche of a $15 million Series C Preferred Stock financing round.

The company noted in a news release that proceeds from the financing will primarily support the advancement of ONL1204 Ophthalmic Solution into a Phase 2 clinical trial in patients with macula-off rhegmatogenous retinal detachment (RRD).

David Esposito, CEO of ONL Therapeutics, noted that with the support of current and new investors, coupled with the opening of the company’s IND for ONL1204 last month, officials are excited about the opportunity to advance the lead asset into a later stage Phase 2 clinical study.

“We expect to initiate this new U.S.-based Phase 2 study in acute retinal detachment next quarter and to continue to generate data throughout the year from our two ongoing chronic Phase 1b studies in geographic atrophy (GA) associated with age-related macular degeneration and progressing open-angle glaucoma (OAG) that are being conducted in Australia and New Zealand,” he said in a statement.

According to the company, the financing was led by Bios Partners and included new investors Visionary Ventures, Alpine Visionary Ventures and Mayewell Capital, as well as existing investors Johnson & Johnson Innovation – JJDC, Inc., Kaitai Capital, PSQ Capital, Michigan Capital Network Venture Fund III, ExSight Ventures, the University of Michigan’s Michigan Investment in New Technology Startups (MINTS) program, Western Michigan University’s Biosciences Research & Commercialization Center, and the Capital Community Angels.

In addition to the Phase 2 study in RRD, the company noted the first tranche of Series C financing will also support the Company’s regulatory preparations for Phase 2 programs in GA and OAG.

“There is excitement across the ophthalmology community for ONL1204’s unique and differentiated mechanism of action, a novel therapeutic approach for patients suffering from serious, vision threatening diseases,” said David Zacks, MD, PhD, co-founder and chief scientific officer of ONL Therapeutics. “Core to our mission is to continue to move forward on our clinical development pathway with the ultimate goal of bringing new neuroprotection therapies to market to address significant unmet medical needs.”

ONL1204 is a novel, first-in-class small molecule Fas inhibitor designed to protect key retinal cells, including photoreceptors, from cell death that occurs across a range of retinal diseases and conditions.

Death of these retinal cells, through both direct and inflammatory signaling pathways, is the root cause of vision loss and the leading cause of blindness. The company’s later-stage clinical development program for ONL1204 currently includes a Phase 2 study in the U.S. for the treatment of macula-off retinal detachment (NCT05730218), a condition for which the compound has been granted orphan drug designation by the United States Food and Drug Administration (FDA).

The company is also conducting a Phase 1b clinical trial in patients with geographic atrophy (GA) associated with age-related macular degeneration (AMD) (NCT04744662) and a Phase 1b clinical trial in patients with progressing open-angle glaucoma (NCT05160805) at sites in Australia and New Zealand. Preclinical work is ongoing to enable clinical trials in other disease indications, including inherited retinal degeneration (IRD; also known as retinitis pigmentosa).