ONL Therapeutics Names Connie Chang as Chief Operating Officer

Company expands leadership team as it advances lead candidate ONL1204 beyond retinal detachment into the chronic conditions of glaucoma and dry age-related macular degeneration

ANN ARBOR, MI – January 19, 2021

ONL Therapeutics, Inc., a biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced the appointment of Connie Chang to the newly created position of chief operating officer (COO). As COO, Ms. Chang will lead key operational workstreams, build and integrate internal capabilities, engage with external stakeholders and develop the company’s global strategic plans, working closely with CEO David Esposito.

“Connie’s broad experience and leadership skills are well aligned with our immediate plans to accelerate the development of our pipeline, enabled by our recent Series B financing,” commented Mr. Esposito. “With our 2021 plans to complete the Phase 1 study of our lead asset in retinal detachment and to further advance programs for ONL1204 in two additional chronic indications, we welcome Connie to the leadership team as we embark on the critical next stage of ONL’s growth.”

Last month, ONL announced the closing of a $46.9 million Series B Preferred Stock financing round, led by Fort Worth, TX-based Bios Partners. The Series B funding supports the ongoing Phase 1 clinical study of ONL1204 in retinal detachment, as well as the advancement of the asset into the chronic conditions of glaucoma and dry age-related macular degeneration.  

“I am thrilled to join ONL Therapeutics at this critical inflection point for the company,” said Ms. Chang. “The potential for ONL’s Fas inhibition platform to bring first-in-class neuroprotection therapies to market and ultimately to help patients suffering from retinal diseases is impressive and compelling, and I look forward to contributing to the company’s mission.”

Ms. Chang brings to ONL a diverse 25-year career spanning large and small biopharma, early-stage technology commercialization and management consulting. She was most recently vice president of corporate affairs at Millendo Therapeutics where she was responsible for building critical infrastructure as the company became publicly traded, including investor and public relations, facilities and operations, information technology and corporate communications. Previously, she was managing director of Fast Forward Medical Innovation at the University of Michigan Medical School, accelerating university-based biomedical technologies through funding, industry collaboration and entrepreneurial support. Prior to that, Ms. Chang was with Sunovion and Pfizer, leading business teams and commercial strategies across multiple categories such as sleep medicine, allergy/respiratory, and cardiovascular. She received her bachelor of arts degree in psychobiology from Harvard University and an MBA from Harvard Business School.

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 were 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 Closes $46.9 Million in Series B Financing to Advance ONL1204 into Three Retinal Disease Indications

Beyond retinal detachment, lead candidate ONL1204 will also advance into the chronic conditions of glaucoma and dry age-related macular degeneration over the next 24 months

ANN ARBOR, MI – December 22, 2020

ONL Therapeutics, Inc., a biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced it closed on $46.9 million in a Series B Preferred Stock financing round. The financing included new investors Bios Partners, which led the round, Johnson & Johnson Innovation – JJDC, Inc., Kaitai Capital, PSQ Capital, and Michigan Capital Network Venture Fund III. Existing investors that participated in the round include ONL Therapeutics management, 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.

Stella M. Robertson, Ph.D., co-founder of Bios Partners and a former vice president in research & development at Alcon Laboratories, and Bill Burns, former CEO of Encore Vision, will join the board of directors of ONL Therapeutics.

“We are excited about the potential of ONL’s Fas inhibition platform to address major unmet medical needs in retinal disease,” said Dr. Robertson. “With its deep scientific foundation, compelling Phase 1 data in retinal detachment, and experienced leadership team, ONL Therapeutics is advancing towards providing neuroprotection for these patients and bringing new therapies to market.”

This funding supports the completion of a Phase 1 study in retinal detachment with ONL’s lead compound ONL1204. In addition, the funding will advance ONL1204 in two chronic indications, glaucoma and dry age-related macular degeneration. ONL1204 will be used in a Phase 1b study for open angle glaucoma, a Phase 1b study in dry age-related macular degeneration and a repeat dose toxicology study to support an accelerated plan for chronic dosing in several retinal diseases.

“ONL Therapeutics is developing first-in-class therapeutics to protect the vision of patients with retinal disease,” commented David Esposito, chief executive officer 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. Bios Partners has been instrumental in working with our team to build the syndicate and strengthen our plans. We look forward to advancing our efforts in the clinic and helping patients in the years to come.”

ONL Therapeutics closed its Series A financing in 2017 to accelerate pre-clinical development of its lead compound ONL1204, a peptide delivered via intravitreal injection, in addition to advancing its gene therapy program. The University of Michigan’s Michigan Investment in New Technology Startups (MINTS) program led the financing and the Novartis Institutes for BioMedical Research participated in the Series A financing.

“Today marks a major milestone in the history of ONL Therapeutics as we secure the financing with industry leading partners to advance our pipeline,” commented David Zacks, M.D., Ph.D., co-founder and chief scientific officer of ONL Therapeutics. “We see great potential in the role of Fas inhibition to provide neuroprotection in patients with retinal cell disease, and we look forward to accelerating our efforts in the clinic.”

About ONL1204
ONL1204 is a novel, 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 were 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 Bios Partners
Bios Partners is a venture capital firm focused on investing in early-stage biopharmaceutical and medical device companies. Founded in 2014 and based in Fort Worth, TX, the firm utilizes an experienced team of industry professionals to actively collaborate with its investment portfolio companies and enhance stakeholder value.

For more information, please visit www.biospartners.com.

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

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