Palatin Reports Second Quarter Fiscal Year 2026 Financial Results and Provides Corporate Update
Advancing differentiated MC4R-based obesity programs into clinical development
-
Melanocortin-based obesity therapies targeting rare MC4R pathway disorders with a primary focus on hypothalamic obesity and Prader-Willi syndrome
- Oral small-molecule MC4R agonist PL7737 progressing through IND-enabling toxicology studies, with IND submission and clinical trial initiation planned for the first half of 2026
- Next-generation selective peptide MC4R agonists d esigned for once-weekly subcutaneous dosing, with IND submission and clinical trial initiation planned for the second half of 2026
-
Executed sublicensing of MC1R agonist PL9643 in
January 2026 , sharpening focus on core obesity portfolio while preserving upside-
Received
$3.8 million in upfront consideration - Eligible for future milestone payments and royalties
-
Received
-
Strengthened balance sheet through successful public financing
-
Completed an
$18.2 million public offering, including the full exercise of the over-allotment option, onNovember 12, 2025
-
Completed an
- Restored NYSE American listing compliance and trading, re-establishing market visibility and liquidity
-
Teleconference and webcast to be held on
February 17, 2026 at11:00 AM ET
"Palatin continues to advance its MC4R-based obesity pipeline, with our oral small-molecule MC4R agonist, PL7737, on track to enter clinical evaluation in the first half of this year, and a long-acting peptide MC4R agonist expected to initiate clinical development in the second half of the year," said
"We delivered meaningful execution across our core strategic priorities, highlighted by the successful completion of our
Obesity Program Update
The obesity program is focused on developing differentiated MC4R agonists designed to enhance patient tolerability, including the potential for reduced gastrointestinal side effects, while minimizing off-target effects such as hyperpigmentation.
Planned clinical studies are expected to enroll and evaluate patients with hypothalamic obesity and Prader-Willi syndrome, addressing populations with significant unmet medical need.
- PL7737 (oral MC4R agonist):
- Demonstrated meaningful weight loss, oral bioavailability across relevant preclinical models.
- IND-enabling toxicology studies are progressing as planned, with an IND submission and initiation of a Phase 1 single- and multiple-ascending dose (SAD/MAD) trial anticipated in the first half of 2026.
- Next-generation selective peptide MC4R agonists:
- Designed for once-weekly subcutaneous dosing, with an IND submission and initiation of a Phase 1 SAD/MAD trial targeted for the second half of 2026.
Out-Licensing Programs Update
- Retinal diseases (MCR agonists) – Collaboration with
Boehringer Ingelheim , providing near-term non-dilutive capital and substantial downstream value potential.- Received an upfront payment of €2.0 million (
$2.3 million ) inAugust 2025 . - Achieved €5.5 million (
$6.5 million ) research milestone inSeptember 2025 , reflecting continued program progress. - Eligible to receive up to €12.5 million (
$14.5 million ) in additional near-term research milestones and up to €260 million ($307.0 million ) in development, regulatory, and commercial milestones, in addition to tiered royalties on net sales.
- Received an upfront payment of €2.0 million (
- PL9643 (MC1R agonist) - Dry Eye Disease – Sublicensing agreement with
Altanispac Labs , providing near-term value, while preserving long-term participation.- Received
$3.8 million in upfront consideration inJanuary 2026 , strengthening the Company's balance sheet. - Eligible to receive additional future payments under the sublicensing agreement, including asset disposition and commercialization milestones, as well as royalties on net sales.
- Received
- PL8177 (MCR agonist) - Ulcerative Colitis, advancing toward strategic partnering following clinical validation.
- Delivered positive Phase 2 proof-of-concept results, supporting the therapeutic potential of the program.
- Active out-licensing discussions are underway, reflecting interest from potential partners in the asset's clinical profile and commercial potential.
- Diabetic nephropathy (MCR agonists) - Building on encouraging clinical data to advance partnering opportunities.
- Reported positive Phase 2 open-label results, supporting the therapeutic potential of the program.
- Ongoing out-licensing discussions continue to explore strategic pathways to maximize the value of the asset.
Corporate Update
Public Offering
On
Each Series J Warrant has an exercise price of
The gross proceeds from the Offering, before deducting the underwriting discounts and commissions and offering expenses, were approximately
The Company intends to use the net proceeds from the Offering to support the development of its obesity program and for working capital and general corporate purposes.
NYSE American
As a result of the closing of the Offering, the Company regained compliance with NYSE American continued listing standard of the NYSE American Company Guide and all applicable requirements for continued listing on NYSE American. Effective
Fiscal Second Quarter Ended
Revenue
For the second quarter ended
Operating Expenses
Total operating expenses were
Other Income / (Expense)
Total other income (expense), net was
Cash Flows
Palatin's net cash used in operations was
Net Loss
Palatin reported a net loss for the second quarter ended
Cash Position
As of
In
Conference Call / Webcast
Palatin will host a conference call and audio webcast on February 17, 2026, at 11:00 a.m. ET 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), Participant Access Code: 967781. 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 1-877-481-4010 (US) or 1-919-882-2331 (International), Replay Passcode 83633. The webcast and telephone replay will be available through
Melanocortin-4 Receptor Agonists Effect on Obesity
Hypothalamic neurons expressing the melanocortin-4 receptor (MC4R) play a central role in regulating stored energy, food intake, and body weight. Genetic mutations that inhibit signaling through the MC4R pathway lead to hyperphagia, decreased energy expenditure and early-onset obesity; such mutations have been identified as the cause of several rare genetic obesity disorders. MC4R agonism represents an attractive target for potential obesity treatments.
About Hypothalamic Obesity
Hypothalamic obesity is a rare and severe form of obesity caused by dysfunction or damage to the hypothalamus, the region of the brain that regulates appetite, satiety, and energy balance. Hypothalamic obesity can occur as an acquired condition, most commonly after surgery or radiation therapy for brain tumors such as craniopharyngioma, or as a congenital disorder associated with genetic syndromes and developmental abnormalities affecting hypothalamic function. Individuals with hypothalamic obesity typically experience rapid, excessive weight gain, uncontrollable hunger, and profound metabolic disturbances that are resistant to conventional diet, exercise, and behavioral interventions. There are currently no approved pharmacologic treatments specifically indicated for hypothalamic obesity, representing a significant unmet medical need.
About Prader-Willi Syndrome
Prader-Willi syndrome (PWS) is a rare, complex genetic neurodevelopmental disorder caused by the loss of function of specific genes on chromosome 15. The condition is characterized by hyperphagia, impaired satiety, developmental delays, reduced muscle tone, endocrine abnormalities, and behavioral challenges. Individuals with PWS typically develop an intense and persistent drive to eat, beginning in early childhood, which can lead to severe obesity and related metabolic complications if not strictly managed. Current treatment approaches focus primarily on symptom management, including nutritional supervision, behavioral interventions, and growth hormone therapy, but there are no approved pharmacologic therapies that directly address hyperphagia or the underlying hypothalamic dysfunction associated with PWS. As a result, PWS represents a significant unmet medical need.
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.
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 more information, visit the company's website at www.palatin.com and follow us on X (formally Twitter) @PalatinTech.
Forward-looking Statements
Statements in this press release that are not historical facts, including statements about future expectations of
|
|
|||||||
|
and Subsidiary |
|||||||
|
Consolidated Statements of Operations |
|||||||
|
(unaudited) |
|||||||
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
||||
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
|
|
|
|
|
|
|
|
|
REVENUES |
|
|
|
|
|
|
|
|
Collaboration and license |
$ 116,036 |
|
$ - |
|
$ 8,963,586 |
|
$ - |
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
Research and development |
4,319,767 |
|
3,429,479 |
|
6,845,533 |
|
9,173,233 |
|
General and administrative |
3,124,817 |
|
1,681,844 |
|
4,785,548 |
|
3,702,775 |
|
Gain on sale of Vyleesi |
- |
|
(2,500,000) |
|
- |
|
(2,500,000) |
|
Total operating expenses |
7,444,584 |
|
2,611,323 |
|
11,631,081 |
|
10,376,008 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
(7,328,548) |
|
(2,611,323) |
|
(2,667,495) |
|
(10,376,008) |
|
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSE) |
|
|
|
|
|
|
|
|
Investment income |
65,185 |
|
29,044 |
|
83,668 |
|
107,620 |
|
Foreign currency transaction gain |
- |
|
143,600 |
|
- |
|
12,000 |
|
Interest expense |
(498) |
|
(3,803) |
|
(2,500) |
|
(9,743) |
|
Total other income (expense), net |
64,687 |
|
168,841 |
|
81,168 |
|
109,877 |
|
NET LOSS |
$ (7,263,861) |
|
$ (2,442,482) |
|
$ (2,586,327) |
|
$ (10,266,131) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
$ (2.86) |
|
$ (5.92) |
|
$ (1.47) |
|
$ (25.36) |
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares |
2,539,632 |
|
412,697 |
|
1,755,641 |
|
404,799 |
|
|
|||
|
and Subsidiary |
|||
|
Consolidated Balance Sheets |
|||
|
(unaudited) |
|||
|
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ 14,476,162 |
|
$ 2,564,265 |
|
Accounts Receivable |
1,636,325 |
|
- |
|
Other receivables |
- |
|
29,468 |
|
Prepaid expenses and other current assets |
1,354,992 |
|
325,695 |
|
Total current assets |
17,467,479 |
|
2,919,428 |
|
|
|
|
|
|
Property and equipment, net |
113,485 |
|
129,444 |
|
Right-of-use assets - operating leases |
346,764 |
|
161,166 |
|
Other assets |
- |
|
56,916 |
|
Total assets |
$ 17,927,728 |
|
$ 3,266,954 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' DEFICIENCY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
$ 5,453,080 |
|
$ 6,998,806 |
|
Accrued expenses |
659,841 |
|
881,412 |
|
Short-term operating lease liabilities |
219,727 |
|
129,812 |
|
Total current liabilities |
6,332,648 |
|
8,010,030 |
|
|
|
|
|
|
Long-term operating lease liabilities |
129,061 |
|
33,969 |
|
Total liabilities |
6,461,709 |
|
8,043,999 |
|
|
|
|
|
|
Stockholders' equity (deficiency): |
|
|
|
|
Preferred stock of |
|
|
|
|
and outstanding designated as follows: |
|
|
|
|
Series A Convertible: authorized 4,030 shares as of |
|
|
|
|
and outstanding 4,030 shares as of |
40 |
|
40 |
|
Series D Convertible: authorized 3,400 shares as of |
|
|
|
|
and outstanding 3,400 shares as of |
34 |
|
34 |
|
Common stock of |
|
|
|
|
issued and outstanding 1,757,199 shares as of |
17,572 |
|
9,296 |
|
Additional paid-in capital |
473,108,599 |
|
454,287,484 |
|
Accumulated deficit |
(461,660,226) |
|
(459,073,899) |
|
Total stockholders' equity (deficiency) |
11,466,019 |
|
(4,777,045) |
|
Total liabilities and stockholders' equity (deficiency) |
$ 17,927,728 |
|
$ 3,266,954 |
View original content to download multimedia:https://www.prnewswire.com/news-releases/palatin-reports-second-quarter-fiscal-year-2026-financial-results-and-provides-corporate-update-302688156.html
SOURCE