On February 17, 2021 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, reported results for its second quarter ended December 31, 2020 (Press release, Palatin Technologies, FEB 17, 2021, View Source [SID1234575181]).
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Second Quarter Ended December 31, 2020 Financial Highlights
Net loss for the quarter was $(10.0) million, or $(0.04) per share, compared to a net loss of $(5.2) million, or $(0.02) per share for the comparable quarter of 2019;
The increase in net loss was primarily attributable to commercial expenses related to Vyleesi and to PL9643’s Phase 2 study for the treatment of dry eye disease.
As of December 31, 2020, the Company had $72.2 million in cash and cash equivalents and $4.7 million in accounts receivable, compared to $82.9 million in cash and cash equivalents and no accounts receivable as of June 30, 2020, with no outstanding debt.
Business Highlights and Updates
Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi (bremelanotide injection)
Vyleesi gross sales for the quarter ended December 31, 2020 amounted to $943,950. Vyleesi product revenue was $(163,971), net of allowances and accruals. Vyleesi gross sales for the period July 25 to September 30 amounted to $809,100. Vyleesi product revenue was $(288,560), net of allowances and accruals;
Restructured the distribution network and procedures improving the patient experience; expanded contact with prescribers and healthcare providers through virtual meetings; increased insurance reimbursement coverage; and initiated a highly selective digital marketing and telemedicine campaign to rebuild awareness and demand among pre-menopausal women with a geo-targeting approach.
Anti-Inflammatory / Autoimmune Programs
Announced positive results in its Phase 2 study of PL9643 for the treatment of dry eye disease (DED);
Announced statistically significant improvements in multiple signs and symptoms in the moderate to severe patient population after 2 weeks of dosing and at the 12-week visit.
There were no safety signals identified and PL9643 had excellent ocular tolerability.
Statistical significance for the primary endpoints was not reached in the overall enrolled population that included mild, moderate, and severe patients, as measured at the 12-week primary evaluation visit.
A Phase 2/3 Clinical trial with PL9643 for the treatment of DED is currently planned for mid-calendar year 2021;
Filed an international patent application under the Patent Cooperation Treaty (PCT) directed to the composition of PL9643 and a related family of melanocortin agonist peptides; and
A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is targeted to start mid-calendar year 2021, with data readout potentially in mid-calendar year 2022.
"Working through the melanocortin system, PL9643 is a novel approach to treating dry eye disease. The emerging profile of PL9643, with its rapid therapeutic onset and excellent tolerability profile, is a potentially distinct advance in dry eye therapy," stated Carl Spana, Ph.D., President and CEO of Palatin. "The positive PL9643 Phase 2 study results identify the most appropriate patient population, endpoints, and timepoints for the next study, which is a Phase 2/3 study targeted for mid-calendar year 2021, with data readout in the first half of calendar year 2022. Regarding Vyleesi, our measured plan and investment is showing positive trends and returns with a significant rise in payer reimbursement and double-digit increases to month over month prescription numbers continuing through January 2021."
Conference Call / Webcast
Palatin will host a conference call and audio webcast on February 17, 2021 at 11:00 a.m. Eastern Time to discuss the quarter ended December 31, 2020 results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-866-248-8441 (US/Canada) or 1-856-344-9206 (international), conference ID 2203098. The audio webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and audio webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (US/Canada) or 1-719-457-0820 (international), passcode 2203098. The webcast and telephone replay will be available through February 24, 2021.