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 

ONL Therapeutics Closes Series A Financing to Support Development of Novel Retinal Cell Protection Platform for Treatment of Ocular Diseases

Proceeds to Support Final Development of ONL1204 in Preparation for Retinal Detachment Clinical Trials

ANN ARBOR, MI – May 17, 2017

ONL Therapeutics, Inc., a biopharmaceutical company developing novel therapies for preserving sight in a range of retinal diseases, today announced that it has closed a $4.25 million Series A round of fundraising. Proceeds from the fundraising combined with the recently announced $1 million grant from the National Eye Institute, will primarily be used to finalize preclinical development of ONL1204, the company’s lead therapeutic candidate, in preparation for clinical trials as a potential treatment for retinal detachment. New funds will also support the broadening of the company’s research of ONL1204 into other retinal diseases with significant unmet needs. The financing, which also included conversion of ONL’s previously announced $1.0 million bridge loan, involved both existing and new investors including 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.

ONL1204 is a novel, first-in- class small molecule Fas inhibitor designed to protect the retina from cell death via both direct and inflammatory signalling in a range of retinal diseases. Retinal cell death is the root cause of vision loss from retinal disease and the leading cause of blindness. The company is initially developing ONL1204 for 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). While initial development efforts are focused on retinal detachment, preclinical in vivo data along with a growing body of literature support potential application in glaucoma, both wet and dry age related macular degeneration (AMD), and non-infectious uveitis, among others.

“This fundraising comes at a critical and exciting time for ONL as we are rapidly completing all preclinical development work for ONL1204, while also expanding our research efforts into other ocular indications,” said John Freshley, chief executive officer of ONL Therapeutics. “The support of our new and existing investors is gratifying and validates the important work that our
team has done in demonstrating the role of Fas signaling and the potential of Fas inhibition in a range of ocular diseases.”

As part of the financing, Rafael Castilla, director of investments and structuring at the University of Michigan Investment Office and a supervisor of the MINTS program, will join ONL’s board of directors. Current board member Loic F. Courard will transition to the role of board observer.

“I am excited and honored to join ONL’s board and work alongside the accomplished and talented individuals that comprise the company’s leadership team,” said Mr. Castilla. “This is a pivotal time as the company prepares its lead compound for first-in-human trials and MINTS is thrilled to have the opportunity to participate in this important financing milestone alongside a group of dedicated and strong investors, including Novartis, a recognized leader in ophthalmology.”

In his role at the University of Michigan, Mr. Castilla manages MINTS, the University’s direct investment program in early stage venture companies.  He has also lectured on investment management law at the University of Michigan Law School. A graduate of Yale Law School and Harvard College, he has spent his career in the securities industry and is a CFA charterholder.

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 sight. The death of key retinal cells is the root cause of vision loss and leading cause of blindness, and is implicated in a wide range of retinal diseases, including retinal detachment and both the wet and dry forms of age related macular degeneration (AMD).

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

Contacts:

ONL Therapeutics, Inc.
John Freshley, President and Chief Executive Officer
jfreshley@onltherapeutics.com
(734) 926-5530

Vida Strategic Partners (On behalf of ONL)

Stephanie Diaz (investors)
sdiaz@vidasp.com
(415) 675-7401

Tim Brons (media)
tbrons@vidasp.com
(415) 675-7402

ONL Therapeutics Strengthens Leadership with Addition to Board of Directors and Expansion of Operations Team

Company Names New Board Member, Continues to Build Out Operations Team Through Appointment and Promotions ANN ARBOR, MI – March 28, 2017 ONL Therapeutics, Inc., a biopharmaceutical company developing novel therapies for preserving sight in a range of retinal diseases, today announced new appointments and promotions involving the company’s board of directors and management team. The company has appointed Christine (Chris) Gibbons as a new, independent member of its board of directors, replacing departing board member, William F. Brinkerhoff. Additionally, ONL has strengthened its operational team, appointing Jana van de Goor, Ph.D., as vice president of project operations, while promoting Linda Johnson to senior vice president of operational excellence and Andrew Kocab, Ph.D., to manager of research operations. Collectively, these changes are designed to further supplement ONL’s leadership as it continues to advance its innovative retinal cell protection technology.“Chris is a valuable addition to our board based on her extensive experience in supporting early-stage medical and technology companies in areas ranging from fundraising to operations. While we look forward to her guidance as we continue to grow and mature as a company, we also want to thank Bill Brinkerhoff for his years of service as a member of our board and wish him well in his future endeavors,” said John Freshley, chief executive officer of ONL Therapeutics. “The expansion of our internal operations team with the addition of Jana and promotions of Linda and Andrew will serve to support our near-term efforts aimed at ramping up our development of ONL1204. Following recent developments including receipt of an NEI grant and closing of a round of interim financing, this strategic expansion of our leadership team further signals the progress we are making in our efforts to develop products that can change the lives of patients with ocular diseases.”Ms. Gibbons has more than thirty years of financial management, fundraising and operating experience. For the past twenty years, she has been deeply involved with early-stage emerging technology companies, both as an investor and a member of entrepreneurial management teams. Together with other founders, she has raised over $80 million in start-up capital to launch and support fourteen new ventures. Ms. Gibbons currently serves as co-founder and chief operating officer of HistoSonics, Inc., a medical device company developing a non-invasive, image- guided, highly precise tissue ablation technology for cost effective treatments of significant cancers and diseases.Prior to HistoSonics, she has held various leadership roles in entrepreneurial ventures including Executive in Residence (EIR) for Venture Investors, LLC, chief financial officer for Sensicore, a company with lab-on-a-chip sensor products (acquired by a division of GE), vice president of finance for Ardesta, an investor in “small-tech” opportunities and partner and chief financial officer of Seaflower Ventures, a venture capital firm focused on early-stage biomedical opportunities. Ms. Gibbons also serves as an advisor to Apjohn Ventures Fund LP, is a member of the University of Michigan’s Venture Center Council and is an advisory board member of Michigan State University’s Center for Venture Capital, Private Equity and Entrepreneurial Finance.Dr. van de Goor joins ONL following more than 15 years at Genentech, where she held a range of research and development positions of increasing responsibility. Most recently, she served as a global project team leader for KADCYLA ® , a first-in- class antibody drug conjugate for the treatment of HER2-positive metastatic breast cancer, and several other oncology clinical candidates. As a leader of these cross-functional teams, she was responsible for the development of clinical candidates from pre-IND phase through clinical development and launch. Earlier in her career with Genentech, Dr. van de Goor led research efforts into the molecular mechanism of cell death and contributed to the development of novel cell lines expressing apoptosis inhibitors to prolong cell viability. She will leverage her expertise on cell death in her new role with ONL, where she will be responsible for leading the company’s ongoing development efforts for ONL1204. Dr. van de Goor has served as a consultant to ONL since 2014.Ms. Johnson, who joined ONL in late 2014 as senior vice president of operations, will now serve as the company’s senior vice president of operational excellence. In this new role, she will be responsible for overseeing efforts to scale the company’s operational processes and entrepreneurial culture to align with the ongoing advancement of the ONL1204 program. Ms. Johnson has over 20 years of pharmaceutical industry experience with responsibilities ranging from principal research scientist through development team leader. Prior to joining ONL, she served as an executive director for Pfizer Worldwide Development. In that role, she led global, multi-disciplinary teams in the development of more than 30 clinical candidates across a wide range of therapeutic areas and through all phases of drug development. During her final two years with Pfizer, Linda served as a global leader, overseeing the development and clinical activities for a therapeutic portfolio of 10 – 15 candidates.Since joining ONL in 2015, Dr. Kocab has played a key role supporting senior leadership in a range of efforts spanning both corporate and research activities. Importantly, he recently spearheaded the development and submission of grant applications to the National Institutes of Health and Orphan Drug applications to the United States Food and Drug Administration. Dr. Kocab’s research background involves cell signaling pathways related to cell death and inflammation. Specifically, he has undertaken research into the signaling from receptors closely related to Fas, as well as the effector proteins involved in regulating these processes. This expertise will be particularly relevant in his new role as he continues to build ONL’s fundamental understanding of how Fas inhibitors may protect key retinal cells, including photoreceptors, from cell death that occurs in a range of retinal diseases and conditions.About ONL1204ONL1204 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 is initially developing ONL1204 for 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). While initial development efforts are focused on retinal detachment, preclinical in vivo data along with a growing body of literature support potential application in several additional ocular diseases including age related macular degeneration (AMD).About ONL TherapeuticsONL 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 sight. The death of key retinal cells is the root cause of vision loss and leading cause of blindness, and is implicated in a wide range of retinal diseases, including retinal detachment and both the wet and dry forms of age related macular degeneration (AMD). For more information about ONL Therapeutics, please visit www.onltherapeutics.com.Contacts:ONL Therapeutics, Inc. John Freshley, President and Chief Executive Officer jfreshley@onltherapeutics.com (734) 926-5530Vida Strategic Partners (On behalf of ONL)Stephanie Diaz (investors) sdiaz@vidasp.com (415) 675-7401Tim Brons (media) tbrons@vidasp.com (415) 675-7402

ONL Therapeutics Receives Nearly $1.0 Million Grant from National Eye Institute for Continued Advancement of ONL1204 Program

Grant Funding Combined with Recent Financing Will Support Final IND-Enabling Studies for Novel Retinal Disease Drug Candidate

ANN ARBOR, MI – March 21, 2017

ONL Therapeutics, Inc., a biopharmaceutical company developing novel therapies for preserving sight in a range of retinal diseases, today announced that the company has been awarded a Commercialization Readiness Pilot (CRP) grant of approximately $1.0 million from the National Eye Institute (NEI) to continue advancement of ONL1204, the company’s lead therapeutic candidate. 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.

ONL intends to use the funding from this CRP grant to support the remaining ONL1204 preclinical development activities required for submission of an investigational new drug (IND) application. The company is initially developing ONL1204 for 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). While initial development efforts are focused on retinal detachment, preclinical in vivo data along with a growing body of literature support potential application in several additional ocular diseases including age related macular degeneration (AMD).

ONL has previously received Phase I and Phase II Small Business Innovation Research (SBIR) research grants from the NEI that have helped support the company’s preclinical development work to date. This includes establishment of proof-of- concept for Fas inhibition in rodent models of retinal detachment, the identification and formulation of ONL1204, and initial pharmacokinetic and toxicology research for the compound. The CRP program which has awarded the latest grant is designed to provide additional financial resources to assist companies in transitioning previously funded SBIR Phase II projects to the commercialization stage.

“We are excited and grateful for this additional NEI grant funding as it allows ONL to build upon the promising preclinical work that we have conducted to date. The area of retinal cell protection represents a critical unmet medical need that we believe can have an important impact on the preservation of vision for patients with a range of ocular diseases and conditions,” said John Freshley, chief executive officer of ONL Therapeutics. “By providing the funds that will help us advance ONL1204 to the point of IND filing, the NEI is playing a key role in research that may one day make a difference in the lives of ocular disease patients. We appreciate their support and look forward to completing the important work that this grant is making possible.”

In addition to the CRP grant, ONL has also recently raised more than $1.0 million through an interim financing involving both existing and new investors, including Novartis and Invest Michigan. Dr. Cynthia Grosskreutz, Global Translational Medicine Head for Ophthalmology at Novartis joins the ONL Board of Directors as an observer. These funds will also be used to complete IND-enabling activities and advance ONL1204 toward human clinical trials. “The CRP grant, renewed commitment from our existing investors, and new commitment from investors such as Novartis validates the clinical and commercial potential of our technology and provides ONL access to unique ocular drug development expertise,” stated Mr. Freshley. “The combined funding will accelerate our development efforts aimed at moving ONL1204 into the clinic.”

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 sight. The death of key retinal cells is the root cause of vision loss and leading cause of blindness, and is implicated in a wide range of retinal diseases, including retinal detachment and both the wet and dry forms of age related macular degeneration (AMD).

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

Contacts:

ONL Therapeutics, Inc.
John Freshley, President and Chief Executive Officer
jfreshley@onltherapeutics.com
(734) 926-5530

Vida Strategic Partners (On behalf of ONL)

Stephanie Diaz (investors)
sdiaz@vidasp.com
(415) 675-7401

Tim Brons (media)
tbrons@vidasp.com
(415) 675-7402