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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Palatin Technologies Inc New | AMEX:PTN | AMEX | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
-0.07 | -3.32% | 2.04 | 2.21 | 1.9717 | 2.12 | 375,390 | 00:26:40 |
CRANBURY, N.J., Nov. 14, 2022 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced financial results for its fiscal first quarter ended September 30, 2022.
"Topline results from our Phase 3 pivotal study of PL9643 is currently expected in the second quarter calendar of 2023, and the interim analysis from the Phase 2 study of oral PL8177 is currently expected in the first calendar quarter of 2023, with topline data expected in the third calendar quarter of 2023," stated Carl Spana, Ph.D., President and CEO of Palatin. "We closed on a $10 million equity offering earlier this month, which strengthened our balance sheet, providing us an operating cash runway through calendar year 2023."
Dr. Spana further commented, "Vyleesi brand value metrics continue to reflect significant growth. In fact, prescription refills, which is a top indicator of patient satisfaction, exceeds 50% of total prescriptions dispensed. Furthermore, net product revenue increased 13% and prescriptions dispensed increased 17% over the last quarter."
Financial Highlights for the Fiscal First Quarter Ended September 30, 2022
Business Highlights and Recent Updates
Fiscal First Quarter Ended September 30, 2022 Financial Results
All share and per share amounts are presented on a post-reverse-split basis, giving effect to the 1- for-25 reverse stock split.
Revenue
Total revenue consists of gross product sales of Vyleesi, net of allowances and accruals. Vyleesi gross product sales to pharmacy distributors for the quarter ended September 30, 2022, were $2.3 million, with net product revenue of $869,654, compared to gross product sales of $1.4 million, with net product revenue of $159,482, for the comparable quarter in 2021. Gross product sales increased 64% and net product revenue increased 445% over the comparable quarter in 2021.
Operating Expenses
Total operating expenses for the quarter ended September 30, 2022, were $9.6 million, compared to $7.4 million for the comparable quarter in 2021. The increase in operating expenses was the result of increased research and development expenses primarily related to our ongoing pivotal Phase 3 clinical trial of PL9643 and Phase 2 clinical trial of oral PL8177, offset by decreased commercial expenses related to Vyleesi.
Other Income / (Expenses)
Total other income, net, consist mainly of unrealized foreign currency transaction gains, of $418,376 for the quarter ended September 30, 2022, compared to $107,359 for the comparable quarter in 2021.
Cash Flows
Palatin's net cash used in operations for the quarter ended September 30, 2022, was $8.6 million, compared to net cash used in operations of $6.4 million for the same period in 2021. The difference in net cash used in operations is mainly due to increased operating expenses in the quarter ended September 30, 2022.
Net Loss
Palatin's net loss for the quarter ended September 30, 2022, was $8.3 million, or $(0.86) per basic and diluted common share, compared to a net loss of $7.1 million, or $(0.75) per basic and diluted common share for the same period in 2021.
The increase in net loss for the quarter ended September 30, 2022 over the quarter ended September 30, 2021, was mainly due to the increase in operating expenses offset by an increase in net product revenue of Vyleesi.
Cash Position
As of September 30, 2022, Palatin's cash and cash equivalents were $21.2 million with $2.0 million of accounts receivable, compared to cash and cash equivalents of $29.9 million with $1.8 million of accounts receivable as of June 30, 2022.
The $21.1 million of cash and cash equivalents as of September 30, 2022, does not include $9.1 million of net proceeds from the Registered Direct Offering, which closed in November 2022, and the $15 Million Private Placement of Redeemable Convertible Preferred Stock. This $15 million is being held in an escrow account, pending the investors' election to redeem the shares for cash or in notes, or convert the shares to common stock. Palatin currently expects an operating cash runway through calendar year 2023.
Conference Call / Webcast
Palatin will host a conference call and audio webcast on November 14, 2022, 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 1-866-580-3963 (US) or 1-786-697-3501 (International), conference ID 5980994#. The audio 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 audio webcast replay will be available one hour after the completion of the call. To access the telephone replay, dial 1-866-583-1035 (US) or +44 (0) 20 8196 1480 (International), passcode 5980994#. The webcast and telephone replay will be available through November 21, 2022.
About Melanocortin Receptor Agonists and Inflammation
The melanocortin receptor ("MCr") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1r through MC5r. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.
Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.
About Palatin
Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates 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 to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at www.Palatin.com and follow Palatin on Twitter at @PalatinTech.
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 market potential of Vyleesi and other Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, market potential for product candidates, and potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, 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, Palatin's ability to establish and maintain the capability for manufacturing, marketing and distribution of Vyleesi, sales of Vyleesi in the United States and elsewhere in the world, results of clinical trials, regulatory actions by the FDA and other regulatory 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.
Palatin Technologies® and Vyleesi® are registered trademarks of Palatin Technologies, Inc.
PALATIN TECHNOLOGIES, INC. | |||||
and Subsidiary | |||||
Consolidated Statements of Operations | |||||
(unaudited) | |||||
Three Months Ended September 30, | |||||
2022 | 2021 | ||||
REVENUES | |||||
Product revenue, net | $ 869,654 | $ 159,482 | |||
OPERATING EXPENSES | |||||
Cost of products sold | 86,496 | 53,933 | |||
Research and development | 6,027,031 | 3,484,764 | |||
Selling, general and administrative | 3,508,798 | 3,836,542 | |||
Total operating expenses | 9,622,325 | 7,375,239 | |||
Loss from operations | (8,752,671) | (7,215,757) | |||
OTHER INCOME (EXPENSE) | |||||
Investment income | 88,489 | 1,410 | |||
Foreign currency gain | 418,376 | 107,359 | |||
Interest expense | (9,602) | (5,631) | |||
Total other income (expense), net | 497,263 | 103,138 | |||
NET LOSS | $ (8,255,408) | $ (7,112,619) | |||
Basic and diluted net loss per common share | $ (0.86) | $ (0.75) | |||
Weighted average number of common shares outstanding | 9,634,684 | 9,529,322 |
PALATIN TECHNOLOGIES, INC. | |||
and Subsidiary | |||
Consolidated Balance Sheets | |||
(unaudited) | |||
September 30, 2022 | June 30, 2022 | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 21,191,875 | $ 29,939,154 | |
Accounts receivable | 2,022,750 | 1,780,020 | |
Inventories | 857,975 | 944,471 | |
Prepaid expenses and other current assets | 2,104,855 | 1,932,454 | |
Total current assets | 26,177,455 | 34,596,099 | |
Property and equipment, net | 620,917 | 539,314 | |
Right-of-use assets - operating leases | 786,731 | 878,465 | |
Other assets | 56,916 | 56,916 | |
Total assets | $ 27,642,019 | $ 36,070,794 | |
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable | $ 3,774,399 | $ 3,157,617 | |
Accrued expenses | 6,116,841 | 6,875,216 | |
Short-term operating lease liabilities | 343,749 | 371,124 | |
Short-term finance lease liabilities | 102,264 | 100,921 | |
Other current liabilities | 5,523,748 | 5,754,986 | |
Total current liabilities | 15,861,001 | 16,259,864 | |
Long-term operating lease liabilities | 465,091 | 529,398 | |
Long-term finance lease liabilities | 126,333 | 152,407 | |
Other long-term liabilities | 2,740,250 | 2,861,250 | |
Total liabilities | 19,192,675 | 19,802,919 | |
Series B and Series C Redeemable Convertible Preferred Stock of $0.01 par value: authorized, issued, and outstanding 9,000,000 shares as of September 30, 2022 and June 30, 2022, with a liquidiation preference of $15,000,000 | 15,000,000 | 15,000,000 | |
Escrowed proceeds | (15,000,000) | (15,000,000) | |
Stockholders' equity: | |||
Preferred stock of $0.01 par value – authorized 10,000,000 shares (including amounts authorized for | |||
Series B and Series C Redeemable Convertible Preferred Stock): shares issued and outstanding | |||
designated as follows: | |||
Series A Convertible: authorized 4,030 shares as of September 30, 2022: issued and outstanding 4,030 shares | |||
as of September 30, 2022 and June 30, 2022 | 40 | 40 | |
Common stock of $0.01 par value – authorized 300,000,000 shares: | |||
issued and outstanding 9,290,504 shares as of September 30, 2022 and 9,270,947 shares as of June 30, 2022 | 92,905 | 92,709 | |
Additional paid-in capital | 404,605,503 | 404,168,822 | |
Accumulated deficit | (396,249,104) | (387,993,696) | |
Total stockholders' equity | 8,449,344 | 16,267,875 | |
Total liabilities, redeemable convertible preferred stock, and stockholders' equity | $ 27,642,019 | $ 36,070,794 |
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SOURCE Palatin Technologies, Inc.
Copyright 2022 PR Newswire
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