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8-K - CURRENT REPORT - PALATIN TECHNOLOGIES INC | ptn_8k.htm |
Exhibit 99.1
Palatin Technologies, Inc. Reports Third Quarter
Fiscal Year 2018 Results;
Teleconference and Webcast to be held on May 15, 2018
CRANBURY, NJ – May 15, 2018 – 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 announced results for its third quarter ended
March 31, 2018.
Recent Highlights
●
Bremelanotide
- Under development for Hypoactive
Sexual Desire Disorder (“HSDD”):
●
March
2018 – our exclusive North American licensee for
bremelanotide, AMAG Pharmaceuticals, Inc. (“AMAG”),
submitted a New Drug Application (“NDA”) to the U.S.
Food and Drug Administration (“FDA”) for bremelanotide
for the treatment of HSDD in premenopausal women.
●
If
approved, bremelanotide would become the first and only as desired
pharmacologic option in the U.S. indicated for the treatment of
HSDD in premenopausal women.
"The submission of this NDA represents a significant milestone for
the bremelanotide clinical program and our efforts to develop a
treatment for HSDD," said Carl Spana, Ph.D., CEO and President of
Palatin Technologies.
●
Melanocortin Receptor 1
Agonists (“MC1r”) – under development for inflammatory bowel
diseases and ocular indications:
●
May
2018 – Presented positive preclinical MC1r agonist data at
TIDES: Oligonucleotide and Peptide Therapeutics 2018
Meeting.
●
April
2018 – Presented preclinical oral formulation data on
PL-8177, an investigational MC1r agonist for Inflammatory Bowel
Diseases at the 2018 Keystone Symposia on “The Resolution of
Inflammation in Health and Disease.”
●
Phase
1 First-in-Human clinical study of PL-8177 is in progress and on
schedule for top line data in the third quarter of calendar year
2018.
Third Quarter Fiscal 2018 Financial Results
Palatin reported a net loss of $(0.7) million, or $(0.00) per basic
and diluted share, for the quarter ended March 31, 2018, compared
to a net loss of $(3.6) million, or $(0.02) per basic and diluted
share, for the same period in 2017.
The difference in financial results between the three months ended
March 31, 2018 and 2017 was mainly attributable to the decrease in
total operating expenses of $4.3 million that is offset by a
decrease of $1.8 million of recognized revenue during the 2018
period pursuant to our license agreement with AMAG.
-More-
Revenue
For the quarter ended March 31, 2018, Palatin recognized $9.0
million in license and contract revenue compared to $10.8 million
in the same period in 2017. For both periods, 100% of the revenue
Palatin recognized was related to our license agreement with AMAG.
As of March 31, 2018, and June 30, 2017, there was $0.6 million and
$35.1 million, respectively, of current deferred revenue on the
consolidated balance sheet related to this
transaction.
Operating Expenses
Total operating expenses for the quarter ended March 31, 2018 were
$9.5 million compared to $13.8 million for the same period in 2017.
The decrease in operating expenses was mainly attributable to
professional services rendered in connection with our license
agreement with AMAG, which closed in February 2017, and secondarily
to the decrease in development expenses of bremelanotide for HSDD
as we continue our progress with our bremelanotide
program.
Other Income/Expense
Total other income/expense, net was $0.2 million for the quarter
ended March 31, 2018 compared to $0.6 million for the same period
in 2017. Total other income/expense, net for both periods consisted
primarily of interest expense related to Palatin’s venture
debt.
Income Tax
Palatin
licensed bremelanotide to Shanghai Fosun Pharmaceutical Industrial
Development Co. Ltd. (“Fosun”) for the People’s
Republic of China, Taiwan, Hong Kong and Macau, and to Kwangdong
Pharmaceutical Co. Ltd. (“Kwangdong”) for the Republic
of Korea. Pursuant to the license agreements with Fosun and
Kwangdong, $500,000 and $82,500, respectively, was withheld in
accordance with tax withholding requirements in China and the
Republic of Korea, respectively, and will be recorded as an expense
during the fiscal year ending June 30, 2018. For the quarter ended
March 31, 2018, Palatin recorded an income tax benefit of $18,746
related to those withholding amounts utilizing an estimated
effective annual income tax rate applied to the loss for the
quarter and the remaining balance of $275,111 was included in
prepaid expenses and other current assets at March 31, 2018. Any
potential credit to be received by Palatin on its United States tax
returns is currently offset by Palatin’s valuation
allowance.
Cash Position
Palatin’s cash, and cash equivalents were $25.7 million as of
March 31, 2018, compared to cash, cash equivalents, accounts
receivable and investments of $55.6 million at June 30, 2017.
Current liabilities were $13.6 million, net of current deferred
revenue of $0.6 million, as of March 31, 2018, compared to $19.9
million, net of deferred revenue of $35.1 million, as of June 30,
2017.
-More-
In April 2018, Palatin entered into an equity distribution
agreement (“at-the-market program”) with Canaccord
Genuity LLC, pursuant to which Palatin may, from time to time, sell
shares of its common stock at market prices. Palatin has no
obligation to sell any shares under this agreement and may, at any
time, suspend solicitation and offers under this
agreement.
Palatin believes that existing capital resources, together with
proceeds from sales of common stock in its at-the-market program
(if any), will be sufficient to fund our planned operations through
at least June 30, 2019.
CONFERENCE CALL / WEBCAST
Palatin will host a conference call and webcast on May 15, 2018 at
11:00 a.m. Eastern Time to discuss the results of operations in
greater detail and provide an update on corporate developments.
Individuals interested in listening to the conference call live can
dial 1-800-263-0877 (domestic) or 1-323-794-2094 (international),
conference ID 1551025. The webcast and replay can be accessed by
logging on to the “Investor/Webcasts” section of
Palatin’s website at http://www.palatin.com. A telephone and
webcast replay will be available approximately one hour after the
completion of the call. To access the telephone replay, dial
1-888-203-1112 (domestic) or 1-719-457-0820 (international),
passcode 1551025. The webcast and telephone replay will be
available through May 22, 2018.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company
developing targeted, receptor-specific peptide therapeutics for the
treatment of diseases 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.
Forward-looking Statements
Statements in this press release that are not historical facts,
including statements about future expectations of Palatin
Technologies, Inc., such as statements about clinical trial
results, potential actions by regulatory agencies including the
FDA, regulatory plans, development programs, proposed indications
for product candidates and market potential for product candidates,
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
clinical trials, regulatory actions by the FDA and the need for
regulatory
-More-
approvals, Palatin’s ability to fund development of its
technology and establish and successfully obtain regulatory
approvals, 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.
Investor Inquiries:
Stephen T. Wills, CPA, MST
CFO/COO (609) 495-2200
Info@Palatin.com
Media Inquiries:
Paul Arndt, MBA, LifeSci Advisors
Managing Director (646) 597-6992
Paul@LifeSciAdvisors.com
###
(Financial Statement Data Follows)
PALATIN
TECHNOLOGIES, INC.
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and
Subsidiary
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Consolidated
Statements of Operations
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(unaudited)
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Three Months
Ended March 31,
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Nine Months
Ended March 31,
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2018
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2017
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2018
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2017
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REVENUES:
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License and
contract revenue
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$8,962,709
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$10,823,748
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$46,516,370
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$10,823,748
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OPERATING
EXPENSES:
|
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Research and
development
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7,068,849
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9,062,316
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27,277,830
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28,422,975
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General and
administrative
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2,411,302
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4,773,696
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5,581,066
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7,289,342
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Total operating
expenses
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9,480,151
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13,836,012
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32,858,896
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35,712,317
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(Loss) Income from
operations
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(517,442)
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(3,012,264)
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13,657,474
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(24,888,569)
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OTHER INCOME
(EXPENSE):
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Interest
income
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86,496
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6,304
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219,578
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18,940
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Interest
expense
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(326,983)
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(558,702)
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(1,175,023)
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(1,777,222)
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Total other
expense, net
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(240,487)
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(552,398)
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(955,445)
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(1,758,282)
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(Loss) Income
before income taxes
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(757,929)
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(3,564,662)
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12,702,029
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(26,646,851)
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Income tax benefit,
net
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18,746
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-
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192,611
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-
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NET (LOSS)
INCOME
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$(739,183)
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$(3,564,662)
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$12,894,640
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$(26,646,851)
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Basic net (loss)
income per common share
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$(0.00)
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$(0.02)
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$0.07
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$(0.15)
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Diluted net (loss)
income per common share
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$(0.00)
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$(0.02)
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$0.06
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$(0.15)
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Weighted average
number of common shares outstanding used in computing basic net
(loss) income per common share
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197,485,758
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196,580,519
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197,277,286
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179,841,133
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Weighted average
number of common shares outstanding used in computing diluted net
(loss) income per common share
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197,485,758
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196,580,519
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202,712,963
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179,841,133
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PALATIN
TECHNOLOGIES, INC.
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and
Subsidiary
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Consolidated
Balance Sheets
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(unaudited)
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March 31,
2018
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June 30,
2017
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ASSETS
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Current
assets:
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Cash and cash
equivalents
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$25,736,158
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$40,200,324
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Available-for-sale
investments
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-
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249,837
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Accounts
receivable
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-
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15,116,822
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Prepaid expenses
and other current assets
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701,456
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1,011,221
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Total current
assets
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26,437,614
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56,578,204
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Property and
equipment, net
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165,080
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198,153
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Other
assets
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556,915
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56,916
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Total
assets
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$27,159,609
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$56,833,273
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LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIENCY)
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Current
liabilities:
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Accounts
payable
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$793,642
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$1,551,367
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Accrued
expenses
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5,894,877
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10,521,098
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Notes payable, net
of discount and debt issuance costs
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6,921,032
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7,824,935
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Capital lease
obligations
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-
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14,324
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Deferred
revenue
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585,519
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35,050,572
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Total current
liabilities
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14,195,070
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54,962,296
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Notes payable, net
of discount and debt issuance costs
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1,328,973
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6,281,660
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Deferred
revenue
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500,000
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-
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Other non-current
liabilities
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909,179
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753,961
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Total
liabilities
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16,933,222
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61,997,917
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Stockholders’
equity (deficiency):
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Preferred stock of
$0.01 par value – authorized 10,000,000 shares:
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Series A
Convertible: issued and outstanding 4,030 shares as of March 31,
2018 and June 30, 2017
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40
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40
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Common stock of
$0.01 par value – authorized 300,000,000 shares:
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issued and
outstanding 195,477,332 shares as of March 31, 2018 and 160,515,361
shares as of June 30, 2017, respectively
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1,954,773
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1,605,153
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Additional paid-in
capital
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352,125,554
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349,979,373
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Accumulated other
comprehensive loss
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-
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(590)
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Accumulated
deficit
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(343,853,980)
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(356,748,620)
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Total
stockholders’ equity (deficiency)
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10,226,387
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(5,164,644)
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Total liabilities
and stockholders’ equity (deficiency)
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$27,159,609
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$56,833,273
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