– Dry Eye Disease Phase 2 Study Remains on Track – Data Anticipated in 4Q20
– $89 Million in Cash at March 31, 2020
CRANBURY, N.J., April 30, 2020 /PRNewswire/ — Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, today provided an update on business operations as a result of the global COVID-19 pandemic.
The Company has taken steps to ensure the safety and well-being of its employees and clinical trial patients to comply with guidance from federal, state and local authorities, while working to ensure the sustainability of its business operations as this unprecedented situation continues to evolve.
In mid-March, the Company transitioned to a company-wide work from home policy. Business-critical activities continue to be subject to heightened precautions to ensure safety of employees. The Company continues to assess its policies, business continuity plans and employee support.
The Company continues to evaluate the impact of COVID-19 on the healthcare system and work with contract research organizations supporting its clinical, research, and development programs to mitigate risk to patients and its business and community partners, taking into account regulatory, institutional, and government guidance and policies.
Impact of COVID-19 Pandemic Related to Ongoing Programs and Development
Management Statement on COVID-19 Pandemic Impact on Operations
During this pandemic, the safety of Palatin’s employees, clinical trial patients and healthcare partners has been the Company’s number one priority. Assuming partial opening of economic activities by mid-2020, senior management believes there will be limited impact of the pandemic on operations. However, senior management understands there can be further disruptions to business activity based on resurgence of the virus and will take steps to be as prepared as possible for this potential outcome.
Anti-Inflammatory / Autoimmune Programs
A Phase 2 clinical study with PL9643 for dry eye disease started in January 2020, and active patients continue treatment and monthly clinic visits. Enrollment of additional cohorts has been delayed, but we anticipate restarting enrollment in June 2020. Data readout remains on track for the fourth quarter of calendar year 2020 (no delay on anticipated data readout due to COVID-19).
A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is now targeted to start in the first-half of calendar year 2021, with data readout in the first-half of calendar year 2022 (two quarter delay due to COVID-19).
The Company continues its assessment and development work related to the treatment of patients with diabetic retinopathy, with an IND targeted for mid-calendar year 2021 (no delay due to COVID-19).
The Company currently anticipates filing an IND and commencing clinical trials with PL8177 for non-infectious uveitis, for which FDA granted orphan drug designation, in the second-half of calendar year 2021 (one quarter delay due to COVID-19).
Hypoactive Sexual Desire Disorder (“HSDD”) / Vyleesi® (bremelanotide injection)
In January 2020 AMAG Pharmaceuticals, Inc. announced that, as a result of a strategic review, it will divest Vyleesi, which it exclusively licensed from Palatin for North America.
Palatin will provide an update on May 12, 2020, when it reports its financial results for the first quarter of calendar 2020, regarding its rights under the license agreement, the status of AMAG’s divestiture process as it relates to Palatin, and specificity around the impact of the COVID-19 pandemic on Vyleesi sales and marketing.
Palatin continues discussions on Vyleesi collaborations for territories outside the currently licensed territories of North America, China, and Korea, and anticipates executing multiple agreements during the second-half of calendar year 2020 and calendar year 2021 (limited to no delay due to COVID-19).
Natriuretic Peptide Receptor (“NPR”) System Program
PL3994, an NPR-A agonist, will be evaluated in a Phase 2a clinical study in heart failure patients with preserved ejection fraction. The proposed study is a collaboration with two major academic medical centers and is supported by an American Heart Association grant. The study is now anticipated to start patient enrollment in the second half of calendar year 2020 (one quarter delay due to COVID-19).
Palatin’s cash and cash equivalents of $88.9 million as of March 31, 2020, represents cash runway of at least two years based on projected operations.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin’s strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin’s website at www.Palatin.com.
Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, AMAG’s plans to divest Vyleesi, Palatin’s ongoing relationship with AMAG and ability to protect its rights as the Vyleesi licensor, market potential for product candidates, and potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin’s actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin’s actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, transfer of marketing and sale of Vyleesi in North America to another pharmaceutical company, sales of Vyleesi in the United States and elsewhere in the world, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin’s ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin’s products, and other factors discussed in Palatin’s periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release.
Vyleesi® is a registered trademark of AMAG Pharmaceuticals, Inc. in North America and of Palatin Technologies, Inc. elsewhere in the world.
SOURCE Palatin Technologies, Inc.