– Vyleesi™ Approved by FDA for Premenopausal Women with Hypoactive Sexual Desire Disorder (HSDD)
– Approximately $102 Million in Pro Forma Cash and Equivalents at June 30, 2019
CRANBURY, N.J., July 1, 2019 /PRNewswire/ — Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today provided a mid-calendar year update on its corporate and clinical development programs.
“We accomplished our primary objectives of procuring FDA approval of Vyleesi and advancing our pipeline programs,” said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. “The FDA approval is an incredible achievement for Palatin, and we are excited that premenopausal women now have a safe and effective, as-needed treatment option available to them for the treatment of HSDD. Our estimated pro forma cash at June 30, 2019 of $102 million is sufficient to cover planned operations through at least calendar year 2021. We are focused on executing Vyleesi collaborations for territories outside the currently licensed territories of North America, China, and Korea, and initiating multiple Phase 2 trials over the next several quarters for the treatment of non-infectious uveitis, ulcerative colitis and dry eye disease.”
Program and Operational Updates for the Six Months Ended June 30, 2019
Female Sexual Dysfunction / Vyleesi™(bremelanotide)
The U.S. Food and Drug Administration (FDA) granted marketing approval of AMAG Pharmaceuticals, Inc’s New Drug Application (NDA) for Vyleesi™ (bremelanotide injection), a melanocortin receptor agonist developed by Palatin, indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The FDA’s approval of the NDA on June 21, 2019 triggered a $60 million milestone payment to Palatin under its North American license agreement with AMAG. This new treatment will be available as a subcutaneous self-injection in a prefilled disposable autoinjector pen for use in anticipation of a sexual encounter. AMAG is expected to make Vyleesi commercially available in September 2019 through select specialty pharmacies.
Anti-Inflammatory / Autoimmune Programs
Melanocortin Agonists under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases (ulcerative colitis).
PL-8177, a selective MC1r peptide agonist announced positive results of a micro-dose study of radiolabeled PL-8177 using an oral, delayed-release, polymer formulation. The study met all primary and secondary endpoints. PL-8177 is a patented melanocortin receptor 1 agonist with potential application in treatment of ulcerative colitis and other inflammatory bowel diseases. The FDA granted orphan drug designation for PL-8177 for the treatment of non-infectious intermediate, posterior, pan and chronic anterior uveitis. Non-infectious uveitis (NIU) is a group of inflammatory diseases that produces swelling and destroys eye tissue and can result in vision loss. A phase 2 proof-of-concept clinical study with a systemic formulation in NIU patients is anticipated to commence in the fourth quarter of calendar year 2019. A phase 2 proof-of-concept clinical study with an oral formulation in ulcerative colitis patients is anticipated to commence in the first quarter of calendar year 2020.
An IND application for PL-9643, a melanocortin peptide agonist, and a Phase 2 clinical study in dry eye disease is currently anticipated to commence in the first half of calendar year 2020.
Natriuretic Peptide Receptor (“NPR”) System Program
The Company has designed and is developing potential drug candidates that are selective agonist for one or more different natriuretic peptide receptors, including natriuretic peptide receptor-A (“NPR-A”), natriuretic peptide receptor B (“NPR-B”), and natriuretic peptide receptor C (“NPR-C”). Active collaborations with several institutions are ongoing for PL-3994, an NPR-A agonist that has potential utility in the treatment of a number of cardiovascular diseases, including genetic and orphan diseases resulting from a deficiency of endogenous active NPR-A, and PL-5028, a dual NPR-A and NPR-C agonist in development for cardiovascular diseases, including reducing cardiac hypertrophy and fibrosis. A phase 2A clinical trial evaluating PL-3994 in heart failure patients with preserved left ventricular ejection fraction will begin enrollment in the second half of calendar year 2019. This trial is supported by a grant from the American Heart Association.
Genetic Obesity Program
A program for the Company’s Melanocortin receptor 4 (“MC4r”) peptide PL-8905, and orally-active small molecule PL-9610, are currently under investigation for the treatment of rare genetic metabolic and obesity disorders. These programs are under internal evaluation for orphan designation, and an IND filing and the initiation of a Phase 1 study are targeted for the first half of 2020.
Debt and related liabilities decreased from $7.2 million at June 30, 2018 to $0.8 million at June 30, 2019, with final payment due July 2019.
The Company has a $40 million at-the-market offering available for financing flexibility, and it may from time to time, opportunistically, sell shares at prices it believes are advantageous to the Company and its shareholders. The Company has, to date, sold $10.6 million of the available $40 million at-the-market offering.
Cash and cash equivalents at June 30, 2019, on a pro forma basis, which includes the $60 million milestone payment payable by exclusive North American licensee, AMAG Pharmaceuticals, Inc., within 30 days of FDA approval of Vyleesi, is estimated to be $102 million dollars. The Company believes the $102 million is sufficient to fund planned operations through at least calendar year 2021, including the initiation of Phase 2 clinical trials for its ocular program for non-infectious uveitis and its ulcerative colitis program by calendar year end 2019. The Company also intends to complete preclinical development activities and file an IND application for ocular inflammation indications, including dry eye, and commence clinical trials in the first half of calendar year 2020.
About Palatin Technologies
Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases and conditions 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 potential actions by regulatory agencies relating to bremelanotide, labels and indications for bremelanotide, whether AMAG will be successful in marketing bremelanotide in the United States and potential for licensing of bremelanotide in additional territories 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, results of nonclinical, preclinical and toxicology studies, result of clinical trials, regulatory actions by the FDA 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.
VyleesiTM is a trademark of AMAG Pharmaceuticals, Inc.
SOURCE Palatin Technologies, Inc.