ONL Therapeutics Announces First Patient Treated in Phase I Study With ONL1204

ONL Therapeutics transformed into a clinical stage biopharmaceutical company with first-in-human study

ANN ARBOR, MI – October 23, 2019

ONL Therapeutics, Inc., a biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced that the first patient has been treated in the company’s First-in-Human trial with its lead drug candidate ONL1204. The study is being conducted in Australia at leading clinical research centers in Sydney and Melbourne. The study will assess four different doses of ONL1204 and is designed to demonstrate safety and tolerability of the investigational drug in patients with a macula-off rhegmatogenous retinal detachment (RRD).

“This is a transformational step for our company with the announcement of our first patient being treated with ONL1204,” commented David Esposito, CEO of ONL Therapeutics. “I want to thank our dedicated team, our investors, and retinal surgeons around the world who have been seeking a therapeutic intervention to support improving the outcome of the current standard of care surgery for macula-off RRD. We look forward to working with retinal specialists to utilize our Fas inhibition platform to protect the vision of patients with retinal disease.”

ONL1204 has been granted orphan drug designation for the treatment of retinal detachment by the United States Food and Drug Administration (FDA). The company is embarking on a Series B round of financing to continue funding its clinical development plans for ONL1204 and expand the development pipeline of its platform of Fas inhibitors for use in a range of retinal disease indications, including glaucoma, age-related macular degeneration (AMD), and inherited retinal degeneration (IRD; also known as retinitis pigmentosa).

The company raised a $3 million convertible note in August of this year to accelerate its clinical development plans. Current investors in the company include Invest Michigan, the University of Michigan’s Investment in New Technology Startups (MINTS) program, the Biosciences Research & Commercialization Center, Novartis, InFocus Capital Partners, ExSight Ventures, Hestia Investments, and the Capital Community Angels.

“We are excited to be the first clinical research site in the world to administer ONL1204, a first-in-class therapy designed to help patients with a macula-off rhegmatogenous retinal detachment,” said Matthew Simunovic, MB BChir PhD FRANZCO lead investigator at the Sydney Eye Hospital in Sydney, Australia.

The company anticipates the study will take about 12 months to complete. The scientific findings gathered throughout the study will help determine future development plans for the company’s portfolio of products addressing a wide range of retinal diseases.

About ONL1204
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 compoun has been granted orphan drug designation by the United States Food and Drug Administration (FDA). Clinical trial plans are focused first on the acute indication of retinal detachment, with continuing preclinical work occurring to enable clinical trials in other disease indications, including glaucoma, age-related macular degeneration (AMD), and inherited retinal degeneration (IRD; also known as retinitis pigmentosa).

About ONL Therapeutics
ONL Therapeutics (ONL) is a biopharmaceutical company committed to protecting and improving the vision of patients with retinal disease. By advancing a novel breakthrough technology designed to protect key retinal cells from Fas-mediated cell death, ONL is pioneering an entirely 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:
ONL Therapeutics, Inc.
Linda Kemnitz
lkemnitz@onltherapeutics.com

ONL Therapeutics Announces First-in-human Clinical Study With ONL1204

Lead candidate ONL1204 advances into Phase I clinical study in retinal detachment in Australia

ANN ARBOR, MI – October 8, 2019

ONL Therapeutics, Inc., a biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced the initiation of the company’s First-in-Human trial with its lead drug candidate ONL1204. The study is being conducted in Australia at leading clinical research centers in Sydney and Melbourne. The study will assess four different doses of ONL1204 and is designed to demonstrate safety and tolerability of the investigational drug in patients with a macula-off rhegmatogenous retinal detachment (RRD).

“Today marks a major milestone in the history of ONL Therapeutics as we transition into a clinical-stage pharmaceutical company,” commented David Zacks, MD, PhD, Founder and Chief Scientific Officer of ONL Therapeutics. “We see great potential in the role of Fas inhibition to protect the vision of patients with retinal cell disease, and our first-in-human study with ONL1204 helps build the foundation to make a meaningful difference in the lives of patients.”

ONL1204 has been granted orphan drug designation for the treatment of retinal detachment by the United States Food and Drug Administration (FDA). The Company is embarking on a Series B round of financing to continue funding its clinical development plans for ONL1204 and expand the development pipeline of its platform of Fas inhibitors for use in a range of retinal disease indications, including glaucoma, age-related macular degeneration (AMD), and inherited retinal degeneration (IRD; also known as retinitis pigmentosa).

The company raised a $3 million convertible note in August of this year to accelerate its clinical development plans. Current investors in the company include Invest Michigan, the University of Michigan’s Investment in New Technology Startups (MINTS) program, the Biosciences Research & Commercialization Center, Novartis, InFocus Capital Partners, ExSight Ventures, Hestia Investments and the Capital Community Angels.

“We are excited to be working with Novotech, the leading contract research organization throughout Asia, as we embark on our clinical development program with major clinical research centers in Australia,” said Jana van de Goor, PhD, Vice President of Development of ONL Therapeutics. “We recently conducted our site initiation visits with our research partners, and the teams are excited to begin enrolling patients in our study.”

The company anticipates the study will take approximately 12 months to complete. The scientific findings gathered throughout the study will help determine future development plans for the company’s portfolio of products addressing a wide range of retinal diseases.

About ONL1204
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). Clinical trial plans are focused first on the acute indication of retinal detachment, with continuing preclinical work occurring to enable clinical trials in other disease indications, including glaucoma, age-related macular degeneration (AMD), and inherited retinal degeneration (IRD; also known as retinitis pigmentosa).

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 novel breakthrough technology designed to protect key retinal cells from Fas-mediated cell death, ONL is pioneering an entirely 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:
ONL Therapeutics, Inc.
Linda Kemnitz
lkemnitz@onltherapeutics.com

ONL Therapeutics Raises $3 Million in a Convertible Note to Advance ONL1204 Into First-in-Human Clinical Study

Lead candidate ONL1204 will advance to Phase I clinical study in retinal detachment in late 2019

ANN ARBOR, MI – August 22, 2019

ONL Therapeutics, Inc., a biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced it recently raised $3 million in a convertible note financing. Participation in the financing was a balance of current investors, ONL management, and new investors. Current investors included Invest Michigan, the University of Michigan’s Michigan Investment in New Technology Startups (MINTS) program, the Biosciences Research & Commercialization Center, and the Capital Community Angels. The largest new investor in the company is InFocus Capital Partners, a venture capital firm focused on unique investments in the ophthalmology market.

“ONL Therapeutics is developing first-in-class therapeutics to protect the vision of patients with retinal disease,” commented David Esposito, CEO of ONL Therapeutics. “We are grateful to our new and existing investors, who recognize the opportunity we have to make a meaningful difference in the lives of patients. The addition of InFocus Capital Partners to our list of investors will help us advance our efforts in the clinic and accelerate the raising of additional capital to accomplish our goals.”

ONL Therapeutics is currently preparing its lead compound ONL1204 for a Phase I study in retinal detachment to be conducted in Australia later this year. The company is embarking on a Series B round of financing to continue funding its clinical development plans for ONL1204 and expand the development pipeline of its platform of Fas inhibitors for use in a range of retinal disease indications.

“We are excited about the potential of ONL’s Fas inhibition platform to address some major unmet medical needs in retinal disease,” said Ron Weiss, Managing Partner of InFocus Capital Partners. “With its strong scientific foundation, compelling preclinical data, and leadership team’s depth of experience, ONL Therapeutics is well-positioned to bring these therapies to market. We are pleased to support ONL at this pivotal time.”

About ONL1204
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 compoun has been granted orphan drug designation by the United States Food and Drug Administration (FDA). Clinical trial plans are focused first on the acute indication of retinal detachment, with continuing preclinical work occurring to enable clinical trials in other disease indications, including glaucoma, age-related macular degeneration (AMD), and inherited retinal degeneration (IRD; also known as retinitis pigmentosa).

About ONL Therapeutics
ONL Therapeutics (ONL) is a biopharmaceutical company committed to protecting and improving the vision of patients with retinal disease. By advancing a novel breakthrough technology designed to protect key retinal cells from Fas-mediated cell death, ONL is pioneering an entirely 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.

About InFocus Capital Partners
InFocus Capital Partners is a venture capital firm focused on investing in innovative technologies in the ophthalmology market. The investment managers are uniquely positioned to source, understand, and evaluate ophthalmic investments due to their medical expertise, professional business development, and investment experience. InFocus founders are practicing physicians with deep venture experience, knowledge, and professional access.

For more information about InFocus Capital Partners, please visit www.infocuscapitalpartners.com

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

ONL Therapeutics Names Industry Veteran as CEO as Company Prepares for First In Human Clinical Trials

David A. Esposito Appointed President and Chief Executive Officer as Company Accelerates Preparation of ONL1204 for Retinal Detachment Clinical Trial

ANN ARBOR, MI – June 18, 2019

ONL Therapeutics, Inc., a biopharmaceutical company developing novel therapies for preserving vision in a range of retinal diseases, today announced a key leadership appointment as part of its evolution into a clinical-stage pharmaceutical company. David A. Esposito has been appointed chief executive officer and a member of the board of directors, bringing with him a wealth of leadership experience in building life science companies. The appointment of a new CEO is designed to further supplement ONL’s leadership as it continues to advance its innovative retinal neuroprotection technology.

“David is an experienced healthcare executive and combat veteran with a proven track record of building successful life science companies,” said Mark Hooper, Chairman of the Board of ONL Therapeutics. “As ONL continues to prepare for first-in-human clinical trials, David will help accelerate the operating plan for the company. We also want to thank Dr. David Zacks for his leadership as interim CEO during this transition.”

Mr. Esposito has more than twenty-five years of healthcare leadership experience. Most recently, he was the CEO of Armune BioScience, Inc. (cancer diagnostics). In December of 2017, Armune BioScience sold a portfolio of protein biomarkers to Exact Sciences, Inc. (EXAS). Mr. Esposito started his healthcare career with Merck & Co. Inc. as a sales representative calling on ophthalmologists and rose through the ranks of sales, marketing, and commercial strategy for the company. He was the President of Phadia US Inc. (allergy and autoimmune diagnostics) which was sold to Thermo Fisher Scientific (TMO) in September of 2011. Mr. Esposito currently serves on the board of directors of AllerGenis, Shield Diagnostics, and Hemotek. He received a BS in Civil Engineering from the United States Military Academy at West Point and an MBA from Syracuse University.

“I am thrilled to be joining the talented team at ONL Therapeutics as we prepare to enter human clinical trials for ONL1204,” stated Mr. Esposito. “Our novel Fas inhibition platform has the potential to protect vision in patients with a wide range of retinal diseases. I believe strongly in our ability to execute our plans to transition into a clinical-stage biopharmaceutical company and make a meaningful difference in protecting the vision of potentially millions of patients.”
ONL Therapeutics is currently embarking on a Series B round of financing to take its lead compound ONL1204 into clinic and expand the development pipeline of its platform of Fas inhibitors for use in a range of retinal disease indications. Current investors in the company include Novartis, the University of Michigan’s Michigan Investment in New Technology Startups (MINTS) program, Capital Community Angels, Invest Michigan, Biosciences Research & Commercialization Center, and Hestia Investments.

About ONL1204
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, both direct and via inflammatory signaling, 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). Clinical trial plans are focused first on the acute indication of retinal detachment, with continuing preclinical work occurring to enable clinical trials in other disease indications, including glaucoma, age-related macular degeneration (AMD), and inherited retinal degeneration (IRD; also known as retinitis pigmentosa).

About ONL Therapeutics
ONL Therapeutics (ONL) is a biopharmaceutical company committed to protecting and improving the vision of patients with retinal disease. By advancing a novel breakthrough technology designed to protect key retinal cells from Fas-mediated cell death, ONL is pioneering an entirely 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.

Contacts:
ONL Therapeutics, Inc.
David Esposito, President and Chief Executive Officer
desposito@onltherapeutics.com