ONL Therapeutics to Present at the 2015 Ophthalmology Innovation Summit at the American Academy of Ophthalmology Annual Meeting

ANN ARBOR, MI – October 29, 2015

ONL Therapeutics, Inc., a biopharmaceutical company developing novel therapies for preserving sight in a range of retinal diseases, today announced that John Freshley, president and chief executive officer, will present a corporate update at the 2015 Ophthalmology Innovation Summit at the American Academy of Ophthalmology (OIS@AAO) annual meeting being held November 12, 2015. Mr. Freshley’s presentation will take place at 12:21 p.m. PT on Thursday, November 12 at the Planet Hollywood Las Vegas Resort and Casino in Las Vegas, Nevada.

ONL is one of just 13 companies selected to present as part of the BioPharma Company Showcase portion of the 2015 OIS@AAO. During his presentation, Mr. Freshley will highlight the latest developments for the company’s lead drug candidate, ONL1204, initially being developed for the treatment of retinal detachment. Additionally, he will discuss recent advances in ONL’s preclinical program in age-related macular degeneration (AMD).

“ONL is the first and only company focused on preventing the death of key retinal cells, including photoreceptors, which is the root cause of vision loss and leading cause of blindness. OIS is a unique and special event and we are excited to have the opportunity to update the ophthalmology community on the important advances that we have achieved with our novel retinal cell protection technology platform,” said Mr. Freshley. “In addition to our lead program in retinal detachment, we are making exciting progress in the area of atrophic dry AMD, a disease for which we think safe and effective retinal cell protection therapy can have a breakthrough impact on patient outcomes.”

About the Ophthalmology Innovation Summit

The Ophthalmology Innovation Summit (OIS) was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors, and industry executives who are driving ophthalmic innovation. OIS addresses key issues – both hurdles and opportunities while showcasing the most promising private ophthalmic companies.

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, including photoreceptors, against programmed cell death (apoptosis), ONL is pioneering an entirely new approach to preserving sight. The death of key retinal cells, including photoreceptors, is the root cause of vision loss and leading cause of blindness worldwide, and is implicated in a wide range of retinal diseases.

ONL is developing ONL1204, a novel, first-in-class, small molecule peptide for the protection of key retinal cells, including photoreceptors, and expects to advance the compound into clinical trials in retinal detachment in the first half of 2016. While initial development efforts are focused on retinal detachment, a condition for which the company has been granted orphan drug designation, preclinical in vivo data along with a growing body of literature support potential application in age related macular degeneration (AMD) and other chronic retinal diseases. 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 Announces Formation of Scientific Advisory Board

Renowned Retinal Disease Thought Leaders to Help Guide Development of Novel Vision Protection Technology in Age-Related Macular Degeneration (AMD) and Retinal Detachment

ANN ARBOR, MI – October 14, 2015

ONL Therapeutics, Inc., a biopharmaceutical company developing novel therapies for preserving sight in a range of retinal diseases, today announced the formation of a scientific advisory board (SAB) comprised of five of the world’s premier retinal disease thought leaders. The newly appointed SAB will provide ONL with scientific expertise and insight to help guide the optimal development of the company’s novel vision protection technology platform in key retinal diseases and conditions, including age-related macular degeneration (AMD) and retinal detachment. ONL’s unique approach to retinal disease treatment is focused on blocking the programmed cell death (apoptosis) of key retinal cells, including photoreceptors, which is the root cause of vision loss and leading cause of blindness.

Members of ONL’s newly formed SAB include:

Joan W. Miller, M.D., Chair, Department of Ophthalmology, Harvard Medical School and Chief of Ophthalmology, Massachusetts Eye and Ear and Mass General Hospital

Dr. Miller, an internationally recognized expert on retinal disorders, is co-credited with developing verteporfin (Visudyne®), the first AMD treatment approved in the U.S. and around the world.  She is also recognized for co-discovering the role of vascular endothelial growth factor (VEGF) in eye disease and demonstrating the therapeutic potential of VEGF inhibitors. Dr. Miller was a co-recipient of the 2014 Antonio Champalimaud Vision Award, which is the highest distinction in ophthalmology and visual science. Dr. Miller continues investigations to elucidate the molecular pathophysiology of vision loss and to develop improved therapies for retinal disease. Her current clinical and research interests focus on retinal disorders, including age-related macular degeneration (AMD) and diabetic retinopathy.

Allen C. Ho, M.D., Director, Clinical Retina Research Unit and Retinal Surgeon, Wills Eye Hospital; Professor of Ophthalmology at Thomas Jefferson University School of Medicine

Dr. Ho is an internationally recognized retina specialist and a leader in the development of new medical and surgical treatments for retinal disease. He currently serves as attending surgeon and director of retina research at Wills Eye Hospital, one of the most active retinal disease treatment facilities in the country.  Dr. Ho is the principal investigator at Wills Eye Hospital for several collaborative clinical trials evaluating new treatments for age-related macular degeneration and diabetic retinopathy. He is editor-in-chief at Current Opinion in Ophthalmology and chief medical editor of Retina Today, a global publication that features new treatments for retinal disease.

Peter K Kaiser, M.D., Chaney Family Endowed Chair in Ophthalmology Research and Professor of Ophthalmology, Cleveland Clinic Lerner College of Medicine

In his roles as professor of ophthalmology at the Cleveland Clinic Lerner College of Medicine and staff surgeon in the vitreoretinal department at the Cole Eye Institute, Dr. Kaiser is sought after for his expertise in retinal diseases and disorders. Actively involved in retinal clinical research, Dr. Kaiser is study chairman of numerous major, multi-center, international clinical trials and is a principal investigator in many other trials. He is editor-in-chief of Retinal Physician and serves on the editorial boards of the American Journal of Ophthalmology, Retina, Retina Today, and Ocular Surgery News. Highly-regarded for his expertise, Dr. Kaiser is also the team ophthalmologist for the Cleveland Cavaliers.

Naresh Mandava, M.D., Sue Anschutz-Rodgers Chair in Retinal Diseases and Chair, Department of Ophthalmology, University of Colorado
One of the foremost experts in the medical and surgical management of retinal diseases such as macular degeneration, diabetic retinopathy and retinal detachment, Dr. Mandava has spent years spearheading research into cutting edge treatments in these areas.  An active author, he has written more than 200 peer-reviewed publications, book chapters and reviews, research presentations, and scientific abstracts and posters spanning a broad area of retinal research.  Dr. Mandava holds five issued patents, which have all been licensed by industry, and has developed four technologies currently in human clinical trials.  In addition, he is a co-founder of several medical and device companies in the field of ophthalmology.  As chair of ophthalmology for the past decade, he has grown the faculty to 65 members and has led the expansion of the University of Colorado Health Eye Center to one of the premier and largest eye centers in the country.

Charles C. Wykoff, M.D., Ph.D., Director of the Greater Houston Retina Research Foundation with Retina Consultants of Houston

A highly-regarded thought leader in retinal diseases and disorders, Dr. Wykoff is director of one of the country’s highest volume retina practices and research foundations. After graduating from MIT and Harvard Medical School, he completed ophthalmology residency and vitreoretinal fellowship at Bascom Palmer Eye Institute where he was awarded the Heed and Ronald Michels Awards. He previously earned a Ph.D. from Oxford University while on the prestigious Marshall Scholarship. He is an expert in clinical trial design and coordination with research interests pertaining to AMD, retinal vascular disorders, and surgical retinal pathologies. He has received the AAO Achievement Award, is active in all of the major US retinal societies and is the Vit-Buckle Society Academic Program Director.

“We are gratified that such an impressive collection of the country’s top retinal disease thought leaders is interested in supporting our research and development of novel, first-in-class vision protective agents. We believe that this speaks directly to the potential impact that the inhibition of apoptosis within the retina can have in preserving sight in a range of retinal diseases and conditions,” said David Zacks, M.D., Ph.D., co-founder and chief science officer of ONL Therapeutics. “We expect that the collective expertise of these individuals will play a vital role in our development strategy for ONL1204 in both retinal detachment and age-related macular degeneration. We thank them for their membership on our scientific advisory board and look forward to the important contributions that each will make.”

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, including photoreceptors, against programmed cell death (apoptosis), ONL is pioneering an entirely new approach to preserving sight. The death of key retinal cells, including photoreceptors, is the root cause of vision loss and leading cause of blindness worldwide, and is implicated in a wide range of retinal diseases.

ONL is developing ONL1204, a novel, first-in-class, small molecule peptide for the protection of key retinal cells, including photoreceptors, and expects to advance the compound into clinical trials in retinal detachment in the first half of 2016. While initial development efforts are focused on retinal detachment, a condition for which the company has been granted orphan drug designation, preclinical in vivo data along with a growing body of literature support potential application in age related macular degeneration (AMD) and other chronic retinal diseases. 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
(646) 319-8981

ONL Therapeutics Provides Update on Novel Photoreceptor Protection Platform for Retinal Diseases

Company Promotes Lead Development Compound and Expands Clinical Program to Include Dry and Wet Age-Related Macular Degeneration (AMD)

ANN ARBOR, MI – June 15, 2015

ONL Therapeutics, Inc., a biopharmaceutical company developing novel therapies for preserving sight in a range of retinal diseases, today provided an update on the company’s ongoing drug development program to block the programmed cell death (apoptosis) of photoreceptors. Death of photoreceptors, which occurs in a range of retinal diseases, is the root cause of vision loss and leading cause of blindness. The company’s recent research and development efforts have led to a number of key milestones, including the promotion of a new lead development candidate and the expansion of its planned clinical program to include both dry and wet forms of age-related macular degeneration (AMD) based on promising preclinical in vivo data.

As a result of ongoing research, ONL has recently identified and patented a novel, first-in-class small molecule peptide, ONL1204, with an attractive profile for inhibiting the Fas pathway, a primary mediator of photoreceptor apoptosis. Researchers have successfully demonstrated the link between Fas pathway activation and a number of retinal diseases and conditions, including retinal detachment and both wet and dry AMD. ONL1204 is an analog of Met12, ONL’s first generation Fas inhibitor, and has demonstrated dramatically enhanced potency both in vitro and in vivo as compared to Met12, while also displaying improved pharmaceutical properties. Based on these significant attributes, ONL has promoted ONL1204 to its lead development candidate and intends to advance the compound into clinical trials in retinal detachment in the first half of 2016.

While initial development efforts are focused on retinal detachment, ONL has also recently generated preliminary data in two distinct dry AMD in vivo models demonstrating that its novel Fas inhibition platform protects both photoreceptors and the underlying retinal pigment epithelium (RPE). This is consistent with a growing consensus in the scientific literature about the role of the Fas pathway in dry AMD. Research is increasingly demonstrating that in dry AMD, Fas not only plays a role in photoreceptor death, but also in the death of the RPE that causes Geographic Atrophy (GA).

Based on the company’s new data in AMD, ONL is expanding its preclinical and clinical development planning to validate its findings and support initiation of clinical studies in both dry and wet AMD. This work will be conducted concurrently with ONL’s clinical development in retinal detachment. Combined, the estimated market for these initial indications that ONL plans to target is greater than $12 billion globally.

“We are excited about the important recent advances we have made in connection with our novel photoreceptor protection technology program. ONL1204 is a potent molecule that displays an excellent profile as a therapeutically relevant Fas inhibitor with applications to address key unmet needs of retinal disease patients,” said John Freshley, ONL’s president and chief executive officer. “Our new data in models of dry AMD is particularly exciting as this disease has such extreme unmet needs and protection of RPE would represent a true therapeutic breakthrough.”

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 photoreceptors against programmed cell death (apoptosis), ONL is pioneering an entirely new approach to preserving sight. The death of photoreceptors, which is the root cause of vision loss and leading cause of blindness worldwide, is implicated in a wide range of retinal diseases.

ONL is advancing a novel, first-in-class, small molecule peptide for the protection of photoreceptors. While initial development efforts are focused on retinal detachment, a condition for which the company has been granted orphan drug designation, preclinical in vivo data along with a growing body of literature support potential application in age related macular degeneration (AMD) and other chronic retinal diseases. For more information about ONL Therapeutics, please visit www.onltherapeutics.com.

Contacts:

ONL Therapeutics, Inc.
John Freshley, 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
(646) 319-8981

ONL Therapeutics to Present at Upcoming Investor and Scientific Conferences

ANN ARBOR, MI – March 12, 2015

ONL Therapeutics, Inc., a biopharmaceutical company developing novel therapies for preserving sight in a range of retinal diseases, today announced that members of the company’s senior management team will be presenting at multiple upcoming investor and scientific conferences. John Freshley, president and chief executive officer, will present a corporate update at the 22nd Annual Future Leaders in the Biotech Industry conference being held March 20, 2015 in New York City.

David Zacks, M.D., Ph.D., chief science officer, will participate on a scientific panel at the upcoming meeting of the Vit-Buckle Society being held in Miami, FL. The panel, entitled “Bench to Bedside,” will include several of the world’s top thought leaders in retinal disease treatment and address some of the most promising new drug candidates in the ophthalmic space.

Details of Mr. Freshley’s Future Leaders presentation are as follows:

Date:                                Friday, March 20, 2015
Time:                               2:30 – 2:40 p.m. (Eastern) followed by a breakout session
Room/Location:         Millennium Broadway Hotel, Presentation Room 508

Details of Dr. Zacks’ Vit-Buckle Society panel are as follows:

Title:                                Scientific Session 3: Bench to Bedside
Moderator:                   Derek Kunimoto, M.D., J.D.
Participants:                Steve Charles, M.D., Samir Patel, M.D., Carmen A. Puliafito, M.D., MBA and David Zacks, M.D., Ph.D.
Date:                                Friday, March 20, 2015
Time:                               3:15 – 4:00 p.m. (Eastern)
Room/Location:         Fontainebleau Miami Beach Hotel, Fleur De Lis Ballroom

About ONL101
ONL101 is a first-in-class therapeutic that works by protecting photoreceptors against the programmed cell death (apoptosis) that occurs during the course of a broad range of retinal diseases and conditions. It is this death of photoreceptors that is the root cause of vision loss and the leading cause of blindness. Preclinical data to date for the product demonstrates its ability to protect photoreceptors against the apoptosis process triggered by retinal detachment. In in vivo retinal detachment models, up to 80 percent of the photoreceptor cells that would normally die without treatment were kept alive following administration of ONL101.

About ONL Therapeutics
ONL Therapeutics (ONL) is a biopharmaceutical company committed to protecting and improving the vision of patients with a range of retinal diseases and conditions. By advancing a novel breakthrough technology designed to protect photoreceptors against programmed cell death (apoptosis), ONL is pioneering an entirely new approach to preserving sight. The company’s lead therapeutic candidate, ONL101, is a first-in-class small molecule peptide initially being developed for the protection of photoreceptors in retinal detachment, a condition for which the product has been granted orphan disease designation. For more information about ONL Therapeutics, please visit www.onltherapeutics.com

Contacts:

ONL Therapeutics, Inc.
John Freshley, 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
(646) 319-8981