Palatin Technologies Inc. (NYSE MKT:PTN) Q4 2020 Earnings Conference Call - Final Transcript
Sep 28, 2020 • 11:00 am ET
This represents an approximately two quarter delay, which is due to the impact of the COVID-19 pandemic. We are using this additional time to expand our clinical and scientific understanding of melanocortin system and ocular inflammatory disease.
Updating our oral colon release formulation for PL-8177 as a treatment for ulcerative colitis and other inflammatory bowel diseases. We are conducting all required preclinical activities and drug product manufacturing to begin a Phase II proof of mechanism study, which is targeted to start patient enrollment in the first half of calendar 2021.
Now finally, based on our research work on the natriuretic peptide system, our drug candidate PL-3994 and natriuretic peptide receptor A agonist will be evaluated in a Phase IIa clinical study in heart failure patients with preserved ejection fraction. The clinical study is a collaboration with two major academic medical centers and is being supported by an American Heart Association grant. All required approvals are in place and drug has been provided to the clinical trial site. And we expect the first patient in the study in the fourth quarter of calendar 2020.
You can find additional information on our programs on our website, www.palatin.com. Past year has certainly had its challenges with multiple external events impacting our operations. In response, our executive management, employees and Board of Directors acted quickly to adjust our business operations, we have been able to continue to advance our programs.
In addressing the COVID-19 pandemic, we took immediate actions to ensure the safety of our employees, patients, and healthcare partners. We put in place operational processes that have allowed our employees to remain highly productive.
Our ability to continue to advance our development programs and our healthy cash position will allow Palatin to emerge in this pandemic in a strong position. However, we will also remain diligent putting plans in place should the virus make a resurgence. A major development was our reacquisition of the North American rights for Vyleesi from AMAG Pharmaceuticals. We believe in the potential of Vyleesi as a treatment for premenopausal women with HSDD and view this as an opportunity to increase the value of our company.
Under Steve Wills direction, we have put in place an excellent commercial team, and they plan to demonstrate the commercial value of Vyleesi to support our objective of licensing Vyleesi to a commit -- partner committed to realizing its value. Our Chinese and Korean partners with our support are now advancing Vyleesi into clinical studies to support their regulatory submissions for ultimate approval and sale of Vyleesi in those territories.
For our dry eye disease program, we initiated and completed enrollment in a Phase II clinical study, and we are on track for data by year-end calendar 2020. If the study is positive, we are positioned to move into Phase III pivotal studies in the first half of calendar 2021.
As we look forward to 2021, we will continue to deal with the operational challenges posed by the COVID-19 pandemic. We have a