ONL Therapeutics Closes 2nd Tranche of $46.9 Million Series B Financing Upon Achieving ONL1204 Development Milestones

– Lead candidate ONL1204 Ophthalmic Solution has advanced into chronic indications of open-angle glaucoma (OAG) and geographic atrophy (GA) associated with age-related macular degeneration (AMD) –

– Phase 1b studies in patients with OAG and GA will evaluate safety, pharmacokinetics and preliminary efficacy –

ANN ARBOR, Mich., Jan. 13, 2022 (GLOBE NEWSWIRE) — ONL Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced it has closed on its second tranche of the Company’s Series B financing. The total proceeds raised in the Series B was $46.9 million.

“We are excited to have reached our critical 2021 milestones, advancing ONL1204 into open-angle glaucoma and GA associated with dry AMD,” said David Esposito, Chief Executive Officer of ONL Therapeutics. “With the support of our investors, we are grateful for the opportunity to further expand our development program into two chronic indications, each with significant unmet medical needs, while also working to close out our Phase 1 study in retinal detachment.”

The financing included lead investor Bios Partners; additional new investors Johnson & Johnson Innovation – JJDC, Inc., Kaitai Capital, PSQ Capital, and Michigan Capital Network Venture Fund III; and continuing investors InFocus Capital Partners, 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.

“Based on the current data being generated across three indications, Bios Partners remains enthusiastic about the potential for ONL1204, with its novel mechanism of action, to play a critical role in meeting the large unmet clinical need in retinal degenerative and neurologic diseases,” said Stella Robertson, Ph.D., co-founder of Bios Partners and member of the board of directors of ONL Therapeutics.

In addition to completing the Phase 1 studies across three indications, the second tranche of financing also supports the Company’s regulatory plans to prepare for Phase 2 programs in the United States.

“The potential role of Fas inhibition to provide a novel therapeutic approach for patients with retinal diseases such as glaucoma and GA is at the core of our mission,” commented David Zacks, M.D., Ph.D., co-founder and Chief Scientific Officer of ONL Therapeutics. “We are taking important steps forward on our clinical development pathway and our ultimate goal of bringing new neuroprotection therapies to market.”

About ONL1204 Ophthalmic Solution
ONL1204 is a novel, first-in-class small molecule Fas inhibitor designed to protect key retinal cells, including photoreceptors, from cell death that occurs in 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 ONL1204 development program focused its first indication on the treatment of retinal detachment, 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) and a Phase 1b clinical trial in patients with progressing open-angle glaucoma. Preclinical work is ongoing to enable clinical trials in other disease indications, including inherited retinal degeneration (IRD; also known as retinitis pigmentosa). In addition, the Company continues to advance a novel gene therapy approach for Fas inhibition.

About ONL Therapeutics
ONL Therapeutics (ONL) is a clinical-stage biopharmaceutical company committed to protecting and improving the vision of patients with retinal disease. By advancing a breakthrough technology designed to protect key retinal cells from Fas-mediated cell death, ONL is pioneering a new approach to preserving vision. ONL is developing a platform of products for use in a wide range of blinding diseases, including retinal detachment, glaucoma, AMD and IRD.

For more information about ONL Therapeutics, please visit www.onltherapeutics.com.

Company Contact:
Linda Kemnitz
ONL Therapeutics, Inc.
lkemnitz@onltherapeutics.com