Oyster Point Pharma Announces Collaboration with Adaptive Phage Therapeutics (APT) to Target Ophthalmic Diseases

PRINCETON, NJ — June 10, 2021 (GLOBE NEWSWIRE) — Oyster Point Pharma, Inc. (Nasdaq: OYST), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies to treat ocular surface diseases, today announced a newly formed research collaboration with Adaptive Phage Therapeutics (APT) to leverage APT’s PhageBankTM technology for the development of potential treatments for multiple ophthalmic diseases.

APT’s PhageBankTM technology is engineered as an ever-expanding library of bactericidal agents, called bacteriophages(“phages”), to provide broad-spectrum coverage. Phages are viruses found in the natural environment that infect and replicate specifically in bacteria. Once a bacteriophage attaches to a susceptible bacterium it causes the host cell to die, releasing new bacteriophage to infect other bacteria. APT’s approach provides expanded bacterial coverage where prior, traditional, antibiotic approaches have diminished coverage or have become obsolete due to emerging antimicrobial resistance (AMR).

Under the terms of the collaboration agreement, Oyster Point Pharma has the option and certain rights to obtain an exclusive license to develop and commercialize APT’s PhageBank™ technology for ophthalmic diseases or disorders. Under the license terms, if such option is exercised, Oyster Point Pharma has agreed to pay APT potential development and regulatory milestones, as well as the potential for sales-related milestones and tiered royalties of net sales, if a licensed phage therapy is approved by the U.S. Food and Drug Administration (FDA). APT retains production rights to PhageBank™ and will supply Oyster Point Pharma product at an agreed-upon cost-plus model.

“We are excited to be partnering with Oyster Point Pharma, an innovation leader in developing therapeutics for the treatment of ocular surface disease and working together to potentially bring new much-needed therapies to a variety of unmet medical needs in the ophthalmic field,” said Greg Merril, APT’s CEO and co-founder. “The plan is to design these ophthalmic therapies as the first evergreen antimicrobials to potentially enter the ophthalmic market. As the targeted bacterial pathogens develop resistance, APT plans to dynamically optimize the formulation with its PhageBankTM technology to avoid product obsolescence that has previously plagued antibiotics.”

“Antibiotic resistance of bacterial pathogens and the formation of antibiotic-resistant biofilm in the eye are a serious and growing problem, made more acute by the possibility of blindness where patient infections cannot be effectively treated using conventional approaches,” said Jeffrey Nau, Ph.D. M.M.S., president and chief executive officer of Oyster Point Pharma. “By partnering with APT, we plan to utilize the company’s innovative PhageBankTM technology to potentially develop treatments for ophthalmic indications. Effective treatments are needed for ophthalmic bacterial infections today as well as antibiotic resistant eye disease that may develop in the future.”

Oyster Point Pharma plans to discuss additional details at the upcoming Analyst Day, planned for July 15, 2021. Please use the following link to register for the Analyst Day (https://media.rampard.com/20210715/).

Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies to treat ophthalmic diseases. Oyster Point’s lead clinical program is focused on the development of OC-01 (varenicline) nasal spray, a highly selective cholinergic agonist being developed as a multidose preservative-free nasalspraytotreatthesignsandsymptomsofdryeyediseaseandneurotrophickeratopathy. In December 2020, Oyster Point submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease. The Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021, with a planned U.S. launch of OC-01 (varenicline) nasal spray in the fourth quarter of 2021, if approved by the FDA. OC-01 (varenicline) nasal spray is an investigational new drug and has not been approved for any use in any country. The safety and efficacy of OC- 01 (varenicline) nasal spray have not been established. In addition, Oyster Point is developing its proprietary Enriched Tear Film (ETFTM) Gene Therapy. ETFTM Is an adeno-associated virus (AAV)- based gene therapy approach where a target gene is delivered to human lacrimal gland cells via intralacrimal gland injection for the potential treatment of select ocular surface diseases. Rather than replacing a gene that is defective or missing, a new target gene is delivered that potentially may produce a selected naturally occurring protein, enzyme, or other therapeutic gene product. The goal for this target gene is to produce a selected gene product to change cell behavior and function on the ocular surface.

Adaptive Phage Therapeutics is a clinical-stage company advancing therapies to treat antimicrobial resistant (AMR) infections. Prior antimicrobial therapeutic formulations have failed to adapt to evolving resistance, causing those drug products to become rapidly less effective in commercial use. APT’s PhageBankTM technology is engineered as an ever-expanding library of bactericidal agents, called bacteriophages (“phages”), to provide broad spectrum of coverage. PhageBankTM phages are matched through a proprietary phage susceptibility assay that APT has teamed with Mayo Clinic Laboratories to commercialize on a global scale. APT’s technology was originally developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under FDA emergency Investigational New Drug allowance, APT has provided investigational PhageBankTM therapy to treat more than 40 critically ill patients in which standard-of-care antibiotics had failed. For more information, visit http://www.aphage.com.

Bacteriophages, also known as phages, are viruses that are found in the natural environment that infect and replicate specifically in bacteria. Once a bacteriophage attaches to a susceptible bacterium it causes the host cell to die, releasing new bacteriophage to infect other bacteria.

Phages can have activity against both treatable and antibiotic-resistant bacteria. Bacteriophage have been used as antibacterial therapy since shortly after they were discovered in the early 20th century and have been previously used to treat diseases of the ocular surface in humans1.

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that reflect the current beliefs, expectations, and assumptions of the Company regarding the future of the Company’s business, our future plans and strategies, regulatory approvals, clinical results, future financial condition, and other future conditions. All statements other than statements of historical facts contained in this press release, including express or implied statements regarding product candidates, regulatory approvals, planned pre-clinical studies and clinical trials, expected results of pre-clinical studies or clinical trials, and their timing and likelihood of success, expected research and development costs, as well as plans and objectives of management for future operations, are forward-looking statements. The words “if approved,” “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including, among other things:

the likelihood of our pre-clinical studies and clinical trials demonstrating the safety and efficacy of our product candidates, and other positive results; the timing of initiation of our future clinical trials, and the reporting of data from our current and future trials; the timing or likelihood of regulatory filings and approvals for our product candidates; our ability to obtain and maintain regulatory approvals of our product candidates; our plans relating to commercializing our product candidates, if approved; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our plans relating to the further pre-clinical and clinical development and manufacturing of our product candidates, including additional indications which we may pursue; the prevalence of ophthalmic diseases and the size of the market opportunity for our product candidates; the expected potential benefits of strategic collaborations with third parties and our ability to attract collaborators with development, regulatory and commercialization expertise; our ability to recruit and retain key personnel needed to develop and commercialize our product candidates, if approved, and to grow our company; existing regulations and regulatory developments in the United States and other jurisdictions; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available; our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for pre-clinical studies and clinical trials; the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; our financial performance; market conditions; the sufficiency of our existing capital resources to fund our future operating expenses and capital expenditure requirements; and other risks described in the “Risk Factors” section included in our public filings that we have made and will make with the Securities and Exchange Commission. The Company is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events, or otherwise.