CRANBURY, N.J., Oct. 1, 2024 /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 fourth quarter and fiscal year ended June 30, 2024.
“This is a very exciting time for Palatin. We executed on multiple operational and clinical development fronts on all of our programs and are anticipating several key milestones over the coming quarters,” said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. “We are on track to complete enrollment this month in our Phase 2 clinical study of our MC4R agonist plus a GLP-1 agonist in obese patients, with topline data expected early in the first quarter of calendar year 2025. Data to date of GLP-1 agonist monotherapy to treat obesity has shown incredible results, however data also shows that more than two-thirds of patients discontinue use due to side effects and a plateau effect in the first year, and often quickly regain the loss weight. This clearly suggests that a longer-term approach is needed. Our internal research and research by academic groups indicate that combining an MC4R agonist with a GLP-1, like tirzepatide, may result in synergistic effects on weight loss, allowing for increased and/or sustained weight loss at lower and more tolerated doses.”
Dr. Spana, commenting on Palatin’s other clinical development programs, noted, “We have agreement with the FDA on the remaining PL9643 Phase 3 DED trial protocols and endpoints. The MELODY-2 and MELODY-3 studies of PL9643 are expected to begin patient enrollment in the first quarter of calendar year 2025. Lastly, we are actively engaging in collaboration and funding discussions with potential partners that have the financial and operational resources to advance PL9643 for DED through development, approval, and into commercialization.”
Program Updates and Anticipated Milestones
Obesity Program:
Ocular Programs (melanocortin receptor agonists):
Male Sexual Dysfunction Program:
Ulcerative Colitis Program (melanocortin receptor agonist):
Diabetic Nephropathy Program – The BREAKOUT Study (melanocortin receptor agonist):
Vyleesi® (bremelanotide injection) for Hypoactive Sexual Desire Disorder:
Other Corporate
Financings:
Fourth Quarter and Fiscal Year Ended June 30, 2024 Financial Results
Revenue
Total revenue consists of gross product sales of Vyleesi, net of expenses, allowances and accruals, and license and contract revenue.
Pursuant to the completion of the sale of Vyleesi’s worldwide rights for female sexual dysfunction to Cosette Pharmaceuticals for up to $171 million in December 2023, Palatin did not record any product sales to pharmacy distributors, for the fourth quarter ended June 30, 2024. For the fourth quarter ended June 30, 2023, gross product sales were $4.1 million and net product revenue was $1.8 million.
Vyleesi gross product sales to pharmacy distributors for the fiscal year ended June 30, 2024, were $8.9 million, with net product revenue of $4.5 million, compared to gross product sales of $12.5 million, with net product revenue of $4.9 million, for the prior fiscal year.
Operating Expenses
Total operating expenses were $8.7 million for the fourth quarter ended June 30, 2024, compared to $12.6 million for the comparable quarter last year. The decrease was mainly the result of lesser spending on our MCR programs and secondarily the elimination of selling expenses related to Vyleesi.
Total operating expenses for the fiscal year ended June 30, 2024, were $27.0 million, compared to $37.3 million for the prior fiscal year. The decrease was mainly due to the $7.8 million gain recognized on the sale of Vyleesi and secondarily the elimination of related selling expenses.
Other Income / (Expense)
Total other income / (expense), net, consists mainly of offering expenses and the change in fair value of warrant liabilities, which Palatin had recorded as a liability on the consolidated financial statements, including the revisions of certain prior period amounts to correct a misstatement with respect to classifying warrants as equity instead of a liability. The statement of operations was adjusted each quarter to reflect changes in the fair value of these warrants. For the quarter ended June 30, 2023, Palatin recorded a fair value adjustment gain of $0.9 million.
Warrant Liabilities
Palatin assessed the impact of improperly classifying the warrants related to the October 2022 financing within equity, rather than as a warrant liability that is adjusted through charges or credits to the statement of operations to reflect changes in the fair value of the warrants, and determined the impact was not material to any prior period impacted. Accordingly, the Company adjusted prior periods as those financial statements are presented for comparative purposes in future filings.
On January 24, 2024, the Company and warrant holders amended the terms of the warrants related to the October 2022 and October 2023 financings. As a result, the $1.9 million of warrant liabilities as of June 30, 2023, was reclassified to additional paid-in capital upon amendment.
Cash Flows
Palatin’s net cash used in operations for the quarter ended June 30, 2024, was $6.5 million, compared to net cash used in operations of $9.6 million for the same period in 2023. The decrease in net cash used in operations is mainly due to the decrease in operating expenses and secondarily to working capital changes.
Palatin’s net cash used in operations for the fiscal year ended June 30, 2024, was $31.5 million, compared to net cash used in operations of $29.3 million, for the same period in 2023. The increase in net cash used in operations was a result of working capital changes, and increased payments made related to inventory purchase commitments.
Net Loss
Palatin’s net loss for the quarter and fiscal year ended June 30, 2024, was $8.6 million and $29.7 million, or $(0.51) and $(2.02) per basic and diluted common share, respectively, compared to a net loss of $9.8 million and $24.0 million, or $(0.84) and $(2.21) per basic and diluted common share, respectively, for the same periods in 2023.
The decrease in net loss for the quarter ended June 30, 2024, over the quarter ended June 30, 2023, was mainly due to the decrease in Vyleesi operating expenses, offset by the elimination of net product revenue of Vyleesi and the recognition of the change in fair value of warrant liabilities for the quarter ended June 30, 2023.
The increase in net loss for the fiscal year ended June 30, 2024, over the prior fiscal year, was mainly due to the recognition of an income tax benefit related to the sale of New Jersey Net Operating Losses, and the recognition of a gain on purchase commitments for the fiscal year ended June 30, 2023.
Cash Position
As of June 30, 2024, Palatin’s cash and cash equivalents were $9.5 million, compared to cash and cash equivalents of $10.0 million as of March 31, 2024, and $8.0 million with $3.0 million in marketable securities as of June 30, 2023.
The Company is actively engaged with multiple parties for potential funding sources for future operating cash needs.
Palatin’s audited financial statements for the year ended June 30, 2024, to be included in the Annual Report on Form 10-K include an audit report from its independent registered public accounting firm, KPMG LLP, that contains a going concern explanatory paragraph.
Conference Call / Webcast
Palatin will host a conference call and audio webcast on October 1, 2024, 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 1-888-506-0062 (US) or 1-973-528-0011 (International), conference ID 252326. 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 reply, dial 1-877-481-4010 (US) or 1-919-882-2331 (International), passcode 51290. The webcast and telephone replay will be available through October 15, 2024.
About Melanocortin Receptor Agonists
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 Palatin products in development, 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 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 events that occur after the date of this press release.
Palatin Technologies® is a registered trademark of Palatin Technologies, Inc.
(Financial Statement Data Follows)
|
PALATIN TECHNOLOGIES, INC. |
||||||||
|
and Subsidiary |
||||||||
|
Consolidated Statements of Operations |
||||||||
|
(unaudited) |
||||||||
|
Three Months Ended June 30, |
Year Ended June 30, |
|||||||
|
2024 |
2023 |
2024 |
2023 |
|||||
|
REVENUES |
||||||||
|
Product revenue, net |
$ – |
$ 1,758,933 |
$ 4,490,090 |
$ 4,850,678 |
||||
|
License and contract |
– |
3,000 |
– |
3,000 |
||||
|
Total revenues |
– |
1,761,933 |
4,490,090 |
4,853,678 |
||||
|
OPERATING EXPENSES |
||||||||
|
Cost of products sold |
– |
104,032 |
97,637 |
418,470 |
||||
|
Research and development |
4,671,856 |
7,405,681 |
22,400,372 |
22,630,577 |
||||
|
Selling, general and administrative |
4,003,779 |
5,070,318 |
12,270,046 |
15,290,836 |
||||
|
Gain on sale of Vyleesi |
16,436 |
– |
(7,781,844) |
– |
||||
|
Gain on purchase commiment |
– |
– |
– |
(1,027,322) |
||||
|
Total operating expenses |
8,692,071 |
12,580,031 |
26,986,211 |
37,312,561 |
||||
|
Loss from operations |
(8,692,071) |
(10,818,098) |
(22,496,121) |
(32,458,883) |
||||
|
OTHER INCOME (EXPENSE) |
||||||||
|
Investment income |
103,914 |
182,975 |
376,843 |
691,981 |
||||
|
Foreign currency (loss) gain |
(8,900) |
(77,850) |
59,753 |
(429,971) |
||||
|
Interest expense |
(3,373) |
(1,490) |
(17,114) |
(20,013) |
||||
|
Offering expenses |
– |
– |
(696,912) |
(1,115,765) |
||||
|
Change in fair value of warrant liabilities |
– |
895,016 |
(6,962,562) |
4,620,911 |
||||
|
Total other income (expense), net |
91,641 |
998,651 |
(7,239,992) |
3,747,143 |
||||
|
Loss before income taxes |
(8,600,430) |
(9,819,447) |
(29,736,113) |
(28,711,740) |
||||
|
Income tax benefit |
– |
– |
– |
4,674,999 |
||||
|
NET LOSS |
$ (8,600,430) |
$ (9,819,447) |
$ (29,736,113) |
$ (24,036,741) |
||||
|
Basic and diluted net loss per common share |
$ (0.51) |
$ (0.84) |
$ (2.02) |
$ (2.21) |
||||
|
Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share |
16,761,856 |
11,727,401 |
14,697,096 |
10,890,159 |
||||
|
PALATIN TECHNOLOGIES, INC. |
|||
|
and Subsidiary |
|||
|
Consolidated Balance Sheets |
|||
|
(unaudited) |
|||
|
June 30, 2024 |
June 30, 2023 |
||
|
ASSETS |
|||
|
Current assets: |
|||
|
Cash and cash equivalents |
$ 9,527,396 |
$ 7,989,582 |
|
|
Marketable securities |
– |
2,992,890 |
|
|
Accounts receivable |
– |
2,915,760 |
|
|
Inventories |
– |
526,000 |
|
|
Prepaid expenses and other current assets |
242,272 |
1,897,281 |
|
|
Total current assets |
9,769,668 |
16,321,513 |
|
|
Property and equipment, net |
388,361 |
684,910 |
|
|
Right-of-use assets – operating leases |
527,321 |
876,101 |
|
|
Other assets |
56,916 |
56,916 |
|
|
Total assets |
$ 10,742,266 |
$ 17,939,440 |
|
|
LIABILITIES AND STOCKHOLDERS’ DEFICIENCY |
|||
|
Current liabilities: |
|||
|
Accounts payable |
$ 4,101,929 |
$ 4,303,527 |
|
|
Accrued expenses |
4,185,046 |
6,511,059 |
|
|
Short-term operating lease liabilities |
380,542 |
354,052 |
|
|
Short-term finance lease liabilities |
46,014 |
106,392 |
|
|
Other current liabilities |
944,150 |
3,856,800 |
|
|
Total current liabilities |
9,657,681 |
15,131,830 |
|
|
Long-term operating lease liabilities |
163,782 |
544,323 |
|
|
Long-term finance lease liabilities |
– |
46,014 |
|
|
Other long-term liabilities |
1,032,300 |
2,083,200 |
|
|
Warrant liabilities |
– |
1,850,544 |
|
|
Total liabilities |
10,853,763 |
19,655,911 |
|
|
Contingently redeemable warrants |
– |
263,400 |
|
|
Stockholders’ deficiency: |
|||
|
Preferred stock of $0.01 par value – authorized 10,000,000 shares: shares issued and |
|||
|
outstanding designated as follows: |
|||
|
Series A Convertible: authorized 4,030 shares as of June 30, 2024: issued and outstanding |
|||
|
4,030 shares as of June 30, 2024 and June 30, 2023 |
40 |
40 |
|
|
Common stock of $0.01 par value – authorized 300,000,000 shares: |
|||
|
issued and outstanding 17,926,640 shares as of June 30, 2024 and 11,656,714 shares |
|||
|
as of June 30, 2023 |
179,266 |
116,567 |
|
|
Additional paid-in capital |
441,475,747 |
409,933,959 |
|
|
Accumulated deficit |
(441,766,550) |
(412,030,437) |
|
|
Total stockholders’ deficiency |
(111,497) |
(1,979,871) |
|
|
Total liabilities and stockholders’ deficiency |
$ 10,742,266 |
$ 17,939,440 |
|
SOURCE Palatin Technologies, Inc.
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