EX-99.1 2 ptn_ex991.htm PRESS RELEASE Blueprint
 
Exhibit 99.1
 
Palatin Technologies, Inc. Reports Third Quarter
Fiscal Year 2019 Results;
Teleconference and Webcast to be held on May 9, 2019
 
CRANBURY, NJ – May 9, 2019 – 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, 2019.
 
Recent Highlights and Program Updates
 
Female Sexual Dysfunction / Vyleesi™(bremelanotide)
 
Vyleesi, the trade name for bremelanotide - Under development for Hypoactive Sexual Desire Disorder (“HSDD”):
 
The Prescription Drug User Fee Act (“PDUFA”) date for completion of FDA review of the Vyleesi New Drug Application (“NDA”) is June 23, 2019
 
The U.S. Food and Drug Administration (“FDA”) requested a Phase 1 study in premenopausal volunteers assessing short term daily use of Vyleesi. This study, conducted by Palatin and our exclusive licensee for North America, AMAG Pharmaceuticals, was completed and data has been submitted to the FDA
 
Palatin is in discussions with potential collaboration partners for certain regions outside of the licensed territories of North America, China and South Korea
 
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:
 
PL-8177, a selective MC1r peptide agonist:
 
Announced positive top line results of an oral clinical study for ulcerative colitis and other inflammatory bowel diseases
 
Phase 2 proof-of-concept clinical study with the oral formulation in ulcerative colitis patients anticipated to commence in the fourth quarter of calendar year 2019
 
Phase 2 proof-of-concept clinical study with a systemic formulation in non-infectious uveitis (NIU) patients anticipated to commence in the fourth quarter of calendar year 2019
 
Continuing investigation of other possible indications for systemic administration
 
Program is under internal evaluation for orphan designations
 
 
1
 
 
PL-9643, a melanocortin peptide agonist:
 
Continuing with preclinical Investigational New Drug (“IND”) enabling activities for ocular diseases
 
Program is under internal evaluation for orphan designations
 
 Natriuretic Peptide Receptor (“NPR”) System Program
 
We have designed and are developing potential NPR candidate drugs that are selective 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”):
 
PL-3994, an NPR-A agonist that has potential utility in treatment of a number of cardiovascular diseases, including genetic and orphan diseases resulting from a deficiency of endogenous active NPR-A:
 
 Active collaborations with several institutions ongoing
 
PL-5028, a dual NPR-A and NPR-C agonist in development for cardiovascular diseases, including reducing cardiac hypertrophy and fibrosis:
 
 Active collaborations with several institutions ongoing
 
Genetic Obesity Program
 
Melanocortin receptor 4 (“MC4r”) peptide PL-8905 and orally-active small molecule PL-9610 under investigation for the treatment of rare genetic metabolic and obesity disorders:
 
Program is under internal evaluation for orphan designation
 
Corporate
 
Decreased debt and related liabilities from $7.2 million at June 30, 2018 to $1.8 million at March 31, 2019.
 
 
Third Quarter Fiscal 2019 Financial Results
Palatin reported a net loss of $(5.7) million, or $(0.03) per basic and diluted share, for the quarter ended March 31, 2019, compared to a net loss of $(0.7) million, or $(0.00) per basic and diluted share, for the same period in 2018.
 
The difference in financial results between the three months ended March 31, 2019 and 2018 was mainly attributable to the recognition of $9.0 million in license and contract revenue during the 2018 period pursuant to our license agreement with AMAG.
 
Revenue
There were no revenues recorded in the quarter ended March 31, 2019.
 
For the quarter ended March 31, 2018, all the revenue Palatin recognized was related to our license agreement with AMAG.
 
 
2
 
 
Operating Expenses
Total operating expenses for the quarter ended March 31, 2019 were $5.8 million compared to $9.5 million for the comparable quarter in 2018. The decrease in operating expenses was mainly attributable to the completion of the Vyleesi Phase 3 clinical trial program and ancillary studies necessary to file the NDA for Vyleesi in March 2018.
 
Other Income/Expense
Total other income, net was $35,648 for the quarter ended March 31, 2019 compared to total other expense, net of $(0.2) million for the same period in 2018. The difference consisted primarily of the decrease in interest expense related to Palatin’s venture debt.
 
Income Tax
There was no income tax expense, or benefit, recorded in the quarter ended March 31, 2019.
 
Pursuant to the license agreements with our Chinese and South Korean licensees, $500,000 and $82,500, respectively, was withheld in accordance with tax withholding requirements in China and the Republic of Korea, respectively, and was recorded as an expense during the fiscal year ended 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 as of March 31, 2018 of $275,111 was included in prepaid expenses and other current assets. 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 $19.8 million as of March 31, 2019, compared to cash and cash equivalents of $38.0 million at June 30, 2018. Current liabilities were $4.9 million as of March 31, 2019, compared to $10.8 million as of June 30, 2018.
 
Palatin believes that existing capital resources will be sufficient to fund our planned operations through at least May 31, 2020.
 
CONFERENCE CALL / WEBCAST
Palatin will host a conference call and webcast on May 9, 2019 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 1-800-667-5617 (domestic) or 1-334-323-0509 (international), conference ID 7024541. 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 7024541. The webcast and telephone replay will be available through May 16, 2019.
 
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.
 
 
3
 
  
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 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:
 Media Inquiries:
 Stephen T. Wills, CPA, MST
 Paul Arndt, MBA, LifeSci Advisors
 CFO/COO (609) 495-2200
 Managing Director (646) 597-6992
 Info@Palatin.com
 Paul@LifeSciAdvisors.com
 
 
 
 
 
 
4
 
 
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Statements of Operations
(unaudited)
 
 
 
Three Months Ended March 31,
 
 
Nine Months Ended March 31,
 
 
 
2019
 
 
2018
 
 
2019
 
 
2018
 
 
 
 
 
 
 
 
 
 
 
 
 
 
REVENUES:
 
 
 
 
 
 
 
 
 
 
 
 
License and contract
 $- 
 $8,962,709 
 $34,505 
 $46,516,370 
 
    
    
    
    
OPERATING EXPENSES:
    
    
    
    
Research and development
  3,943,982 
  7,068,849 
  10,528,329 
  27,277,830 
General and administrative
  1,818,796 
  2,411,302 
  5,947,943 
  5,581,066 
Total operating expenses
  5,762,778 
  9,480,151 
  16,476,272 
  32,858,896 
 
    
    
    
    
(Loss) income from operations
  (5,762,778)
  (517,442)
  (16,441,767)
  13,657,474 
 
    
    
    
    
OTHER INCOME (EXPENSE):
    
    
    
    
Investment income
  107,460 
  86,496 
  361,212 
  219,578 
Interest expense
  (71,812)
  (326,983)
  (370,981)
  (1,175,023)
Total other income (expense), net
  35,648 
  (240,487)
  (9,769)
  (955,445)
 
    
    
    
    
(Loss) income before income taxes
  (5,727,130)
  (757,929)
  (16,451,536)
  12,702,029 
Income tax benefit
  - 
  18,746 
  - 
  192,611 
 
    
    
    
    
NET (LOSS) INCOME
 $(5,727,130)
 $(739,183)
 $(16,451,536)
 $12,894,640 
 
    
    
    
    
Basic net (loss) income per common share
 $(0.03)
 $(0.00)
 $(0.08)
 $0.07 
 
    
    
    
    
Diluted net (loss) income per common share
 $(0.03)
 $(0.00)
 $(0.08)
 $0.06 
 
    
    
    
    
Weighted average number of common shares outstanding used in computing basic net (loss) income per common share
  207,016,304 
  197,485,758 
  206,148,695 
  197,277,286 
 
    
    
    
    
Weighted average number of common shares outstanding used in computing diluted net (loss) income per common share
  207,016,304 
  197,485,758 
  206,148,695 
  202,712,963 
 
 
5
 
 
PALATIN TECHNOLOGIES, INC.
and Subsidiary
Consolidated Balance Sheets
(unaudited)
 
 
 
March 31,
2019
 
 
June 30,
2018
 
ASSETS
 
 
 
 
 
 
Current assets:
 
 
 
 
 
 
Cash and cash equivalents
 $19,813,349 
 $38,000,171 
Prepaid expenses and other current assets
  697,178 
  513,688 
Total current assets
  20,510,527 
  38,513,859 
 
    
    
Property and equipment, net
  156,648 
  164,035 
Other assets
  338,916 
  338,916 
Total assets
 $21,006,091 
 $39,016,810 
 
    
    
LIABILITIES AND STOCKHOLDERS’ EQUITY
    
    
Current liabilities:
    
    
Accounts payable
 $474,773 
 $2,223,693 
Accrued expenses
  2,640,208 
  2,103,021 
Notes payable, net of discount
  1,328,973 
  5,948,763 
Other current liabilities
  495,169 
  487,488 
Total current liabilities
  4,939,123 
  10,762,965 
 
    
    
Notes payable, net of discount
  - 
  332,898 
Deferred revenue
  - 
  500,000 
Other non-current liabilities
  - 
  456,038 
Total liabilities
  4,939,123 
  12,051,901 
 
    
    
Stockholders’ equity:
    
    
Preferred stock of $0.01 par value – authorized 10,000,000 shares:
    
    
Series A Convertible: issued and outstanding 4,030 shares as of March 31, 2019 and June 30, 2018
  40 
  40 
Common stock of $0.01 par value – authorized 300,000,000 shares:
    
    
issued and outstanding 203,063,429 shares as of March 31, 2019 and 200,554,205 shares as of June 30, 2018
  2,030,634 
  2,005,542 
Additional paid-in capital
  362,033,736 
  357,005,233 
Accumulated deficit
  (347,997,442)
  (332,045,906)
Total stockholders’ equity
  16,066,968 
  26,964,909 
Total liabilities and stockholders’ equity
 $21,006,091 
 $39,016,810 
 
 
 
6