ONL Therapeutics, Inc.

Funds will advance the development of ONL1204 Ophthalmic Solution with the initiation of a Phase 2 global study for the treatment of geographic atrophy (GA) associated with dry age-related macular degeneration (AMD)ANN ARBOR, Mich., Sept. 13, 2024 (GLOBE NEWSWIRE) -- ONL Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced that it has secured $65M in Series D financing. Johnson & Johnson Innovation – JJDC, Inc. led the round that was backed by a consortium of investors that included Bios Partners, Novartis Venture Fund, and Visionary Ventures, amongst others. “We are grateful to our new and returning investors who are making it possible for the company to achieve its vision of helping patients see the future,” commented David Esposito, chief executive officer of ONL Therapeutics. “This new round of funding provides an exciting opportunity for our company to advance the clinical development program for ONL1204.” ONL Therapeutics will continue to work alongside Johnson & Johnson’s Specialty Ophthalmology research and development team to provide a forum for sharing input to the company’s ongoing clinical development plans. ONL Therapeutics is the first and only clinical-stage company focused on the unique mechanism of action (MOA) preventing Fas-mediated death of retinal cells and inflammatory signaling pathways, the root causes of vision loss and blindness. In a Phase 1b clinical trial of ONL1204 Ophthalmic Solution in patients with GA associated with dry AMD, patients treated with ONL1204 showed reductions in the rate of growth of the GA lesion with either a single injection or two injections (90 days apart) after 6 months of treatment compared to sham patients. A consistent treatment effect was seen when comparing treated eyes versus fellow eyes. “This new round of funding builds on the University of Michigan’s support of ground-breaking biomedical research that will enable us to further advance our unique and differentiated clinical program in GA, a disease that is responsible for nearly one in five cases of blindness caused by macular degeneration,” said David Zacks, M.D., Ph.D., co-founder and chief scientific officer of ONL Therapeutics. “With the unique MOA of ONL1204 addressing neuroprotection and our compelling Phase 1 clinical data, we are excited for the potential to bring a new innovation to GA patients around the world.” About ONL1204 Ophthalmic SolutionONL1204 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 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 has also conducted 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. About ONL TherapeuticsONL Therapeutics (ONL) is a clinical-stage biopharmaceutical company committed to developing first-in-class therapeutics to protect and improve 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. For more information about ONL Therapeutics, please visit www.onltherapeutics.com.

Plus, news about ONL Therapeutics, Cidara Therapeutics, Emergent BioSolutions, Vico Therapeutics and Centessa: Valneva gets €61.2M private placement: Valneva said the funds will go toward supporting ongoing Phase 3 and Phase 4 studies of its chikungunya vaccine and commercialization of that shot. It will also use the money to help fund planned Phase 2 trials for its Shigella and Zika vaccine candidates. Immuneering’s small Phase 2a dataset: The company said two of five first-line pancreatic cancer patients responded to its experimental drug, called IMM-1-104, which is designed to inhibit the MAPK pathway and “achieve universal-RAS activity.” One patient had a complete response and another had an unconfirmed partial response. Its stock $IMRX was up about 55% on Friday morning. ONL Therapeutics closes $65M Series D: Johnson & Johnson Innovation led the round . The funds will be used to advance the company’s ONL1204 program, a small molecule Fas inhibitor that aims to protect retinal cells across different eye diseases like macula-off retinal detachment and geographic atrophy. Cidara Therapeutics restructures, lays off 30% of workforce: The biotech took the measures after J&J returned a flu drug earlier this year . Cidara raised $240 million in a PIPE financing in conjunction with the move in April. The reprioritization, announced Thursday, will see the company solely focus on the flu drug, called CD388, and seek partners for its oncology pipeline. Cidara had 69 employees as of April. Emergent BioSolutions gets BARDA award for Ebola, settles case: The company will get $41.9 million to scale up its commercial efforts for Ebanga, its Ebola drug. Separately, Emergent said Friday it had agreed to pay $40 million — mostly from its insurance — to settle a class action lawsuit brought in 2021. Emergent’s shares $EBS were up about 6% on Friday morning. Vico Therapeutics presents interim Phase 1/2a Huntington’s data: The private Dutch biotech said six patients saw a 28% decrease, on average, in CSF mutant huntingtin protein after 12 weeks. There was also no effect on neurofilament light chain. Vico raised a $60 million Series B in January. Centessa Pharmaceuticals upsized its offering to $225 million from $150 million.

ANN ARBOR, Mich., Sept. 10, 2024 (GLOBE NEWSWIRE) -- ONL Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced that the company plans to present clinical data at the upcoming 57th Annual Scientific Meeting of The Retina Society and EURETINA Innovation Spotlight (EIS). The Retina Society Meeting is scheduled for September 11-15, 2024, at the Four Seasons Hotel Ritz Lisbon in Lisbon, Portugal, while the EIS Meeting will take place September 18, 2024, at the International Barcelona Convention Center (CCIB) in Barcelona, Spain. Details of the Retina Society Meeting presentations are as follows: Title:Fas Inhibition with ONL1204 for the Treatment of Geographic Atrophy: Results from a Phase 1b StudyPresenter:Lejla Vajzovic, M.D.Associate Professor of OphthalmologyDuke University Eye CenterTime/Date:10:44 a.m. Western European Summer Time (WEST) on Saturday, September 14, 2024 Title:FAS Inhibition with Intravitreal ONL1204 for the Treatment of Macula-off Rhegmatogenous Retinal Detachment: Results from a Phase 2 StudyPresenter:Durga Borkar, M.D., MMCiAssociate Professor of OphthalmologyDuke University Eye CenterTime/Date:12:46 p.m. WEST on Saturday, September 14, 2024 Details of the EIS Meeting presentation are as follows: Title:Targeting Fas Pathway: ONL Therapeutics’ Approach to Dry AMD (as part of Session 1: Non-neovascular AMD and IRDs)Presenter:David N. Zacks, M.D., Ph.D.Professor, Ophthalmology and Visual Sciences, University of Michigan Chief Scientific Officer, ONL TherapeuticsTime/Date:1:05 – 1:40 p.m. Central European Summer Time (CEST) on Wednesday, September 18, 2024 About ONL1204 Ophthalmic SolutionONL1204 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 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 has also conducted 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. About ONL TherapeuticsONL Therapeutics (ONL) is a clinical-stage biopharmaceutical company committed to developing first-in-class therapeutics to protect and improve 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. For more information about ONL Therapeutics, please visit www.onltherapeutics.com.