Firm has clinical-stage candidates for both indications and preclinical peptides for FSD.
Palatin Technologies completed a public offering that netted $21.1 million. It intends to use the proceeds for working capital and general corporate purposes including its clinical trial program with bremelanotide for female sexual dysfunction (FSD), its PL-3994 programs for asthma, and for the preclinical development of peptides to treat FSD.
“With $21.1 million from this financing and based on our current program and inside expense projections, we anticipate being able to fund our operations through December 31, 2012,” Palatin president and CEO Carl Spana told analysts. “This financing is truly transformational for Palatin, allowing us to concentrate on advancing our programs and not to be concerned with doing small capital raises several times per year.”
Shares of Palatin closed unchanged yesterday at 86 cents, after trading between 84 and 91 cents. Palatin’s public offering of 23 million units consisted of 23 million shares of its common stock, Series A warrants to purchase 2 million shares of its common stock, and Series B warrants to purchase 21 million shares of its common stock at $1 per unit.
Bremelanotide belongs to a class of therapies called melanocortin agonists. It was shown to be safe and well tolerated in a Phase I study in 32 premenopausal women. The company also obtained what it calls encouraging results from a Phase IIa study evaluating bremelanotide in premenopausal women diagnosed with FSD.
Bremelanotide has shown promise in effectively treating erectile dysfunction (ED) in males without the cardiovascular effects found in ED drugs currently available, according to Palatin. The firm conducted four Phase II studies, enrolling more than 1,300 men. Palatin has, however, delayed plans for Phase III studies pending review of FDA concerns about the acceptable benefit/risk ratio to support progression of that clinical trial program.
FSD is also the target of a new series of melanocortin receptor-specific peptides developed by Palatin, of which PL-6983 is the lead candidate. PL-6983 has demonstrated efficacy in inducing erections in animal models and in inducing sexual behavior in an animal model of FSD. In animal models at doses effective for a sexual response, PL-6983 resulted in significantly smaller increases in blood pressure compared to bremelanotide.
PL-3994, a natriuretic peptide receptor A agonist compound, was developed initially for the treatment of congestive heart failure (CHF). Phase I and Phase IIa trials in CHF were successfully completed. Palatin says it is exploring use of PL-3994, a synthetic molecule incorporating an amino acid mimetic, for treatment of acute severe asthma, particularly beta 2 agonist refractory asthma, since it is an area of high unmet medical need.