Full Press Release Details
Palatin Technologies, Inc. Reports Fourth Quarter
And Fiscal Year 2016 Results
CRANBURY, NJ September 20, 2016 Palatin
Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company
developing targeted, receptor-specific peptide therapeutics for the
treatment of diseases with significant unmet medical need and
commercial potential, today announced financial results for its
fourth quarter and fiscal year ended June 30, 2016.
Significant Highlights
- Under development for Hypoactive
Sexual Desire Disorder (HSDD):
two Phase 3 clinical trials for the treatment of HSDD randomized a
total of approximately 1,250 women to evaluate efficacy and safety
of subcutaneous bremelanotide in premenopausal women with HSDD as
an on-demand, as-needed treatment.
enrollment was completed in the fourth quarter of calendar year
patient visits for the efficacy portion of the trials were
completed in the third quarter of calendar year 2016.
results are projected to be released early fourth quarter calendar
a key U.S. Patent on May 31, 2016 for methods of treating female
sexual dysfunction using the dose and formulation utilized in the
Phase 3 trials. The patent expires no earlier than November
2016, Palatin closed on an underwritten offering of units with
gross proceeds of $9.25 million, with net proceeds, after deducting
offering expenses, of approximately $8.5 million. Palatin
shares of common stock and ten-year prefunded Series I warrants to
purchase 2,218,045 shares of common stock at an exercise price of
H warrants to purchase 10,274,646 shares of common stock at an
exercise price of $0.70 per share
2015, Palatin closed on a debt and equity financing with gross
proceeds of $30 million, with net proceeds, after deducting
offering expenses, of $29.7 million, consisting of:
million venture loan, which includes an interest-only payment
period for the first eighteen months of a four year secured term
loan, and Series G warrants to purchase 549,450 shares of common
stock at an exercise price of $0.91 per share
million private placement of Series E warrants to purchase
21,917,808 shares of common stock at an exercise price of $0.01 per
share and Series F warrants to purchase 2,191,781 shares of common
stock at an exercise price of $0.91 per share
Notification for U.S. Patent to issue October 4, 2016, with
composition of matter claims for a broad group of melanocortin
Patent issued September 20, 2016 with composition of matter claims
for a broad family of melanocortin receptor-1 peptides with
potential application in inflammatory disease-related and
autoimmune indications.
Fourth Quarter and Fiscal Year Ended 2016 Financial
Palatin reported a net loss of $(13.4) million, or $(0.09) per
basic and diluted share, for the quarter ended June 30, 2016,
compared to a net loss of $(12.1) million, or $(0.09) per basic and
diluted share, for the same period in 2015. The difference between
the three months ended June 30, 2016 and 2015 was primarily
attributable to the increase in expenses relating to the Phase 3
clinical trial and development program with bremelanotide for HSDD
in the quarter ended June 30, 2016.
For the year ended June 30, 2016, Palatin reported a net loss of
$(51.7) million, or $(0.33) per basic and diluted share compared to
a net loss of $(17.7) million, or $(0.15) per basic and diluted
share for the year ended June 30, 2015. The increase in net loss
for the year ended June 30, 2016, compared to the net loss for the
year ended June 30, 2015 was primarily attributable to the increase
in development costs for the progression of the Phase 3 clinical
trials and development of bremelanotide for HSDD and secondarily
related to the license and contract revenue recognized in the year
ended June 30, 2015.
There were no revenues recorded in the quarter or year ended June
30, 2016 or in the quarter ended June 30, 2015. For the year ended
June 30, 2015, Palatin recognized $12.9 million of license and
contract revenue under the agreement with Gedeon
Operating expenses for the quarter ended June 30, 2016 were $12.7
million, compared to $11.8 million for the comparable quarter of
2015. For the year ended June 30, 2016, Palatin incurred $49.3
million of operating expenses, compared to $30.2 million for the
year ended June 30, 2015. The increase in operating expenses for
the quarter and the year ended June 30, 2016 was the result of an
increase in expenses primarily relating to the Phase 3 clinical
trial and development program with bremelanotide for
Other Income/Expense
Total other income (expense), net, was $(0.6) million for the
quarter ended June 30, 2016, compared to $(0.3) million for the
quarter ended June 30, 2015. For the year ended June 30, 2016,
total other income (expense), net, was $(2.5) million, compared to
$(0.9) million for the year ended June 30, 2015. Total other income
(expense) for both fiscal years ended June 30, 2016 and June 30,
2015 primarily consists of interest expense related to the venture
debt. The increase in total other income (expense), net, for the
year ended June 30, 2016 is due to the additional July 2015 venture
Palatin's cash, cash equivalents and investments were $9.4
million as of June 30, 2016, compared to cash and cash equivalents
of $27.3 million at June 30, 2015. Current liabilities were $14.0
million as of June 30, 2016, compared to $7.4 million as of June
Palatin believes that existing capital resources, together with
approximately $8.5 million received from the August 2016 financing,
will be adequate to fund our planned operations through the quarter
ending December 31, 2016. Assuming the double blind efficacy
portion of the Phase 3 clinical trial of bremelanotide for HSDD is
successful, as to which there can be no assurance, we will need
additional funding to complete required ancillary studies and
clinical trials, prepare and submit regulatory filings for product
approval, and establish commercial scale manufacturing