Outlook Therapeutics Strengthens Board of Directors with Appointment of Julia A. Haller, MD

ISELIN, N.J., Aug. 15, 2022 (GLOBE NEWSWIRE) -- (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced the appointment of Julia A. Haller, MD, to the Company’s Board of Directors.

“We are pleased to welcome Dr. Haller to Outlook Therapeutics’ Board of Directors. As one of the world’s most accomplished professionals in ophthalmic education, research, and clinical ophthalmic practice, she will add tremendous value and insight to Outlook Therapeutics,” said Randy Thurman, Executive Chairman of the Outlook Therapeutics Board of Directors.

Julia A. Haller, MD, Ophthalmologist-in-Chief at Wills Eye Hospital and Professor and Chair of Ophthalmology at Sidney Kimmel Medical College at Thomas Jefferson University, is a trailblazing retina surgeon-scientist and leader who has innovated translational advances against blindness that arises from many retinal diseases. She also combines her deep medical and scientific expertise with efforts to address healthcare disparities and gender inequality.

A Board-certified ophthalmologist, Dr. Haller began her career at the Wilmer Eye Institute at Johns Hopkins Hospital and as a faculty member of the University. Subsequently she moved to Wills Eye Hospital in Philadelphia, where she was appointed Ophthalmologist-in-Chief and William Tasman, MD Endowed Chair as well as Professor and Chair of Ophthalmology at the Sidney Kimmel Medical College of Thomas Jefferson University. Her innovative research has resulted in more than 400 published scientific articles and book chapters on a range of subjects, including clinical trials and other advances in retinal pharmacology.

Dr. Haller commented, “I am delighted with the therapeutic potential of ONS-5010 and the strategic approach Outlook Therapeutics has taken in advancing this drug candidate. I believe ONS-5010 has the potential, when approved, to meet the need for broader patient access to on-label treatment for wet AMD and other retinal diseases, and to mitigate the risks to patients associated with the use of off-label repackaged intravenous bevacizumab from compounding pharmacies. I am honored to become part of this endeavor and look forward to working with the Board and executive leadership team at Outlook Therapeutics.”

“We could not ask for a more accomplished and respected ophthalmologist and scientist to join our Board of Directors,” noted C. Russell Trenary, President and CEO of Outlook Therapeutics. “We welcome Dr. Haller and look forward to her contributions as we move ONS-5010 towards commercialization and patient care. She joins the Board at a pivotal and exciting time at Outlook Therapeutics. Dr. Haller’s expertise aligns perfectly with our mission to develop therapies that preserve the vision of patients worldwide.”

Dr. Haller is the distinguished recipient of numerous honors, including election to the National Academy of Medicine and awards from all the major ophthalmology and retina societies. Her honors include the Crystal Apple Award of the American Society of Retina Specialists for teaching and mentorship, the Kreissig Award from EURETINA, the President's Award from Women in Ophthalmology, a Secretariat Award from the AAO, the Gertrude Pyron Award from the Retina Research Foundation and the ASRS, and a Lifetime Achievement Award from the AAO. She is past President of the American Society of Retina Specialists and the Retina Society, Treasurer of the Macula Society, and former Chair of the Board of Trustees of the Association of University Professors of Ophthalmology and the Council of the American Ophthalmological Society. Dr. Haller serves as Chair of the Board of the College of Physicians of Philadelphia, Vice Chair of Section 6 of the National Academy of Medicine, on the Executive Committee of the Board of the Philadelphia Orchestra and Kimmel Center, and President of the Johns Hopkins Medicine Alumni Association. She is an emeritus trustee of Princeton University. She is a member of the editorial boards of RETINA, Retinal Physician, Ocular Surgery News, Ophthalmology Times, and Evidence-Based Eye Care.

About ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab need to use unapproved repackaged oncologic IV bevacizumab provided by compounding pharmacies, products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 can replace the need to use unapproved repackaged IV bevacizumab from compounding pharmacies for the treatment of wet AMD.



Bevacizumab-vikg is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab-vikg to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.

About Outlook Therapeutics, Inc.

Outlook Therapeutics is a pre-commercial biopharmaceutical company working to develop and launch ONS-5010/ LYTENAVA™ (bevacizumab-vikg), an investigational therapy, as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan and other markets. For more information, please visit .

Forward-Looking Statements



This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “will,” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, statements about ONS-5010’s potential as the first FDA-approved ophthalmic formulation of bevacizumab-vikg, and commercial launch of ONS-5010. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the fiscal year ended September 30, 2021 and subsequent Quarterly Reports on Form 10-Q, which include the uncertainty of future impacts related to the ongoing COVID-19 pandemic. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

CONTACTS:

Media Inquiries:

Harriet Ullman

Vice President

LaVoie Health Science

T: 617-669-3082

Investor Inquiries:

Jenene Thomas

Chief Executive Officer

JTC Team, LLC

T: 833.475.8247

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