ONL Therapeutics Announces Management Team Additions

Company Strengthens Leadership by Naming Chief Science Officer, Chief Medical Officer and SVP of Operations

ANN ARBOR, MI – December 3, 2014

ONL Therapeutics, Inc., a biopharmaceutical company developing novel therapies for preserving sight in a range of retinal diseases, today announced several management team appointments designed to strengthen the company’s leadership as it continues advancement of its novel photoreceptor protection technology. The company has appointed David Kleinman, M.D. as chief medical officer and Linda Johnson as senior vice president of operations, bringing significant industry experience to ONL in the area of ocular drug development. Additionally, David Zacks, M.D., Ph.D., one of the company’s founders, will transition from president and chief medical officer to become the company’s chief science officer and John Freshley will assume an expanded role as president and chief executive officer.

“As we continue to make progress with our development activities in support of our foundational photoreceptor protection technology, as well as ONL101, our lead product candidate for retinal detachment, it is critical that we have an executive team with the experience and skills required for success,” said John Freshley, president and chief executive officer of ONL Therapeutics. “By naming David Zacks as CSO and adding both David Kleinman and Linda Johnson to our core management team, we have more advantageously positioned ONL to maximize the therapeutic potential of our novel technology platform and translate that technology into therapeutic products that can preserve the vision of retinal disease patients.”

Dr. Zacks is a co-founder of ONL and previously served as the company’s president and chief medical officer. In addition to his role with the company, he is an associate professor of ophthalmology, a retinal specialist, and a clinician-scientist at the University of Michigan, Kellogg Eye Center. For over the past 15 years his research has focused on the molecular regulatory mechanisms controlling photoreceptor death or survival in retinal disease. Dr. Zacks is a pioneer and recognized thought leader in the field of retinal neuroprotection and photoreceptor cells physiology. He has demonstrated that the Fas pathway is largely responsible for photoreceptor cell death in retinal detachment and has discovered unique molecules that block the Fas receptor and preserve photoreceptors. Dr. Zacks’ research serves as the scientific foundation for ONL’s technology platform and product pipeline.

Dr. Kleinman is also a retina specialist and has spent over ten years in venture creation and ophthalmic drug and device development. He currently serves as part-time associate professor of ophthalmology on the retina service at the Flaum Eye Institute at the University of Rochester. Previously, Dr. Kleinman helped found MacuSight, a venture capital backed retinal drug development company, where he served as consulting medical director. In his role with MacuSight David assisted in guiding the company through Series A financing, pre-clinical studies, investigational new drug (IND) submission, and Phase I/II clinical development. David has extensive experience consulting for both small and large ophthalmic companies in clinical trial design and execution, regulatory interaction, drug safety monitoring, and the evaluation and advancement of novel ophthalmic technology.

Ms. Johnson has nearly 20 years of pharmaceutical industry experience with responsibilities ranging from principal research scientist through development team leader. She most recently 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 development leader, overseeing all clinical activities for a therapeutic portfolio of 10 – 15 candidates.

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

ONL Therapeutics Receives Phase II SBIR Grant from National Eye Institute for Development of Novel Retinal Disease Treatment

ANN ARBOR, MI – November 12, 2014

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 $1.37 million Small Business Innovation Research (SBIR) Phase II contract from the National Eye Institute (NEI) to advance development of ONL101, 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. This grant will be used to support the remaining ONL101 preclinical development activities required for submission of an investigational new drug (IND) application.

ONL received this funding following the successful completion of a Phase I SBIR project which focused on demonstrating the feasibility of the company’s approach to blocking photoreceptor apoptosis in retinal detachment animal models. This NEI-funded research showed that ONL could deliver the target molecule intravitreally and achieve sufficient retinal concentrations to block apoptosis.

“Receipt of this second SBIR grant from the National Eye Institute provides further validation for our foundational photoreceptor protection technology, as well as our ONL101 product,” said John Freshley, chief executive officer of ONL Therapeutics. “This funding will allow for continued evaluation of ONL101’s ability to protect photoreceptors in cases of retinal detachment and, ultimately, preserve vision. Illustrating this mechanism of photoreceptor protection not only helps advance ONL101 as a treatment for retinal detachment but also provides rationale for the technology’s application to other important retinal diseases such as wet and dry age-related macular degeneration.”

In addition to the SBIR grant, ONL has also raised $1.0 million through a convertible bridge loan from a syndicate led by the Capital Community Angels of Lansing, Michigan. Additional investors included Biosciences Research & Commercialization Center (with funds from the Michigan Economic Development Corporation), ONL management and other unnamed investors. The bridge loan will convert to Series A Preferred shares concurrent with the closing of a Series A financing. Combined, the SBIR grant and bridge loan provide ONL with sufficient capital to complete IND-enabling studies for 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.

ONL is currently preparing for IND-enabling preclinical activities for ONL101 with the expectation of submitting an IND application in late 2015 to support the initiation of a Phase 1 clinical trial in retinal detachment. The company has already completed a pre-IND meeting with the United States Food and Drug Administration (FDA) and the agency has deemed the company’s clinical development plan for ONL101 as acceptable.

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. ONL plans to submit an investigational new drug (IND) application for ONL101 in late 2015 to support the initiation of a Phase 1 clinical trial in retinal detachment. 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 ANNOUNCES LEADERSHIP CHANGES

ONL ANNOUNCES LEADERSHIP CHANGES
October 29, 2013

Ann Arbor, Mich. (October 29, 2013) — ONL Therapeutics today announced the appointments of John Freshley as Chief Executive Officer and Anna Schwendeman as Vice President of Preclinical Development. These appointments follow the sad loss of Co-Founder and former CEO Raili Kerppola to adrenal cancer on June 19, 2013.

Mr. Freshley has spent nearly two decades in leadership roles of various start-up companies within both the software and life science fields. Most recently, John was Chief Business Officer of Compendia Bioscience, a cancer genomics company that was acquired by Life Technologies in 2012. John started the company in 2006 with co-founders from the University of Michigan and served as its first CEO, assembling the management team, securing initial funding and acquiring the company’s first 10 customers. Previously, John had been President and CEO of Genetics Squared, an Ann Arbor start-up focused on developing personalized oncology drugs and diagnostics.

On his new appointment Mr. Freshley said, “I was honored when Raili Kerppola reached out to me early this year to help her lead ONL and transition leadership responsibilities to me. She was a good friend for many years and an inspirational leader in our community as she launched multiple biotech companies while fighting a difficult and tenacious disease.”

“I am excited by this new challenge and look forward to working with our team to advance our important lead compound, ONL-101, into the clinic to benefit patients fighting blindness,” Mr. Freshley concluded.

ONL-101 is the first FAS inhibitor in development for the prevention of blindness in retinal diseases. The company has chosen retinal detachment as its lead indication, for which it has received orphan drug designation from the FDA.

Along with the appointment of Mr. Freshley, the company also announced the appointment of Anna Schwendeman, Ph.D., to lead the company’s preclinical development programs. Dr. Schwendeman has deep expertise in peptide drug manufacturing and regulatory affairs from her time at both Cerenis Therapeutics and Esperion Therapeutics . She has managed all aspects of preclinical product development, clinical trial material production, and has submitted multiple INDs to the FDA and global regulatory agencies. Dr. Schwendeman earned her Ph.D. in Pharmaceutical Chemistry.

“We are thrilled to welcome both Anna and John to the ONL team,” said Co-Founder, President and Chief Medical Officer David Zacks. “They bring a wealth of experience, both scientific and business, that will really drive our company and development programs forward. We are fortunate that Raili identified both John and Anna in the past year to help with the company’s next phase of development. I will be ever thankful for Raili’s effort and dedication. She was a good friend and will be missed by me and many, many others.”

About ONL Therapeutics, LLC.
ONL Therapeutics is dedicated to preventing blindness and improving visual outcomes. Our novel drug programs targeting the FAS apoptotic pathway provide protection for photoreceptors while the underlying disease can be addressed with surgery or concurrent therapies. Photoreceptor cell death is the primary cause of blindness and therapies to protect these cells are crucial if visual outcomes are to improve.

ONL RECEIVES ORPHAN DRUG DESIGNATION FOR ONL-101 IN RETINAL DETACHMENT

ONL RECEIVES ORPHAN DRUG DESIGNATION FOR ONL-101 IN RETINAL DETACHMENT
March 19, 2013

Ann Arbor, Mich. (March 19, 2013) — ONL Therapeutics today announced that it has received an orphan drug designation form the FDA for ONL-101 in its lead indication of retinal detachment. Orphan drug designation provides drug developers multiple benefits including qualification for certain tax incentives related to clinical development and seven years of market exclusivity in the orphan disease, in this case retinal detachment, should the drug be approved as safe and effective.

ONL-101 is small peptide currently in pre-clinical development that protects photoreceptors by blocking the FAS apoptosis pathway that is activated in many retinal diseases, including retinal detachment, age-related macular degeneration, diabetic retinopathy and retinopathy of prematurity. Retinal detachment is the lead indication for ONL-101, but the company plans to pursue additional indications once it has achieved clinical proof-of-concept in retinal detachment.

“We are pleased that our application was accepted,” said ONL Co-Founder and Chief Medical Officer David Zacks. “Retinal detachment is a condition that affects more than 100,000 Americans each year.”

“I have been frustrated as a retinal surgeoun that while surgery has a 90% anatomical success rate, more than 40% of patients with detachments involving the macula (their central vision) do not have driving vision post-surgery in the affected eye,” Zacks continued. “There is a significant and growing need for drugs to protect photoreceptors between the detachment event and the surgery I can perform. I believe our drug will fulfill that need.”

About ONL Therapeutics, LLC.
ONL Therapeutics is dedicated to preventing blindness and improving visual outcomes. Our novel drug programs targeting the FAS apoptotic pathway provide protection for photoreceptors while the underlying disease can be addressed with surgery or concurrent therapies. Photoreceptor cell death is the primary cause of blindness and therapies to protect these cells are crucial if visual outcomes are to improve.