株探米国株
英語
エドガーで原本を確認する

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act Of 1934

 

Date of Report (Date of earliest event reported): March 28, 2025

 

PALATIN TECHNOLOGIES, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-15543

 

95-4078884

(State or other jurisdiction

 

(Commission

 

(IRS employer

of incorporation)

 

File Number)

 

identification number)

 

4B Cedar Brook Drive, Cranbury, NJ

 

08512

(Address of principal executive offices)

 

(Zip Code)

 

Registrant's telephone number, including area code: (609) 495-2200

 

Not Applicable

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class

 

Trading

Symbol

 

Name of Each Exchange

on Which Registered

Common Stock, par value $0.01 per share

 

PTN

 

NYSE American

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 






 

Item 8.01 Other Events.

 

On March 28, 2025, Palatin Technologies, Inc. (the “Company”) issued a press release announcing positive topline results from Phase 2 ulcerative colitis study of oral melanocortin-1 receptor agonist PL8177. On March 31, 2025, the Company issued a press release announcing MC4R agonist bremelanotide co-administered with GLP-1/GIP tirzepatide met its primary endpoint in a Phase 2 obesity study. Copies of the press releases are attached as Exhibits 99.1 and 99.2, and are incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits:

 

99.1

 

Press Release, dated March 28, 2025.

 

 

 

99.2

 

Press Release, dated March 31, 2025.

 

 

 

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 
2

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

PALATIN TECHNOLOGIES, INC.

 

 

Date: March 31, 2025

By:

/s/ Stephen T. Wills

 

Stephen T. Wills, CPA, MST

 

Executive Vice President, Chief Financial Officer and Chief Operating Officer

 

 

 
3

 

EX-99.1 2 ptn_ex991.htm PRESS RELEASE ptn_ex991.htm

EXHIBIT 99.1

 

Palatin Announces Positive Topline Results from Phase 2 Ulcerative Colitis

(UC) Study of Oral Melanocortin-1 Receptor Agonist PL8177

 

 

·

Clinical Remission: Achieved in 33% of PL8177-treated patients versus 0% on placebo after eight weeks of treatment.

 

 

 

 

·

Clinical Response (statistically significant): Demonstrated in 78% of PL8177-treated patients versus 33% on placebo after eight weeks of treatment (p<0.005).

 

 

 

 

·

Symptomatic Remission: Achieved in 56% of PL8177-treated patients versus 33% on placebo after eight weeks of treatment.

 

 

 

 

·

Safety and Tolerability: Excellent, with no adverse events.

 

 

 

 

·

Licensing: Discussions advancing with multiple big pharma companies.

 

CRANBURY, NJ – March 28, 2025/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, announced positive topline results from its Phase 2 study of PL8177, a selective melanocortin-1 receptor (MC1R) agonist, in patients with active ulcerative colitis (UC). This study was designed to assess the safety, tolerability, and effectiveness of PL8177 when taken orally by adults with active UC.

 

“We are thrilled with the positive results in this study, especially the meaningful and high rates of achievement for clinical remission and clinical response. These endpoints align with the FDA's recommended primary and key secondary endpoints for evaluating efficacy in UC clinical trials,” stated Carl Spana, Ph.D., President and CEO of Palatin. “Most patients showed significant symptom and endoscopic score improvements after just eight weeks of treatment. This study evaluated a novel mechanism of action, MC1R agonism, as a potential treatment for UC. Given these positive results, once-daily oral PL8177 could be a safe and effective alternative to immunosuppressive and steroid therapies, which have significant safety and tolerability concerns.”

 

The Phase 2 randomized, placebo-controlled study evaluated twelve patients (nine in the PL8177 arm and three in the placebo arm) with active ulcerative colitis, (defined as having a Mayo Endoscopic Total Score of at least two), for eight weeks of treatment. Treatment with oral PL8177 was well tolerated and no treatment-related side effects were reported. Key findings after eight weeks of treatment are summarized below:

 

 

·

Clinical remission was achieved in 33% (3 of 9) of PL8177-treated patients versus 0% (0 of 3) on placebo.

 

o

Clinical remission is defined per FDA Guidance (April 2022) as a modified Mayo Score (mMS) of 0 to 2, including the following three components: rectal bleeding subscore = 0, stool frequency subscore = 0 or 1, and endoscopy subscore = 0 or 1.

 

· 

Clinical response (statistically significant) was demonstrated in 78% (7 of 9) of PL8177-treated patients versus 33% (1 of 3) on placebo (p<0.005).

 

 

o

Clinical response is defined per FDA Guidance (April 2022) as a decrease from baseline in the mMS of greater than or equal to 2 points and at least a 30% from baseline, and a decrease in rectal bleeding subscore of greater than or equal to 1 or an absolute rectal bleeding subscore of 0 or 1.

 

 

-More-

 

 

 

·

Symptomatic remission was achieved in 56% (5 of 9) of PL8177-treated patients versus 33% (1 of 3) on placebo.

 

o

Symptomatic remission is defined as Mayo stool frequency subscore (SFS) of 0 or 1 without worsening, and Mayo rectal bleeding subscore (RBS) of 0.

 

· 

Results for a subset of patients with more moderate diseaseat baseline, defined by the presence of inflammation in all three colon segments (segment endoscopic score of greater than or equal to 1 in the rectum, descending colon, and sigmoid colon segments) at baseline were:

 

 

o

Three of five (60%) PL8177-treated patients showed improvement in all three segments.

 

 

o

Four of five (80%) PL8177-treated patients showed improvement in two of the three segments.

 

 

o

Zero of one (0%) placebo patients showed improvement in two or more segments.

 

“Despite the advances in therapy for UC, I frequently see patients who struggle with this condition and their symptoms. This is why there remains a strong need for new treatment options that work in different ways,” said Dana J. Lukin MD, PhD, Clinical Director of the Jill Roberts Center for Inflammatory Bowel Disease at Weill Cornell Medicine-New York Presbyterian Hospital. “Seeing a good percentage of patients treated with PL8177 achieve strong results for clinical remission and clinical response in this short study on UC patients is a compelling indicator that melanocortin-1 receptor agonists could be a promising treatment option for UC.”

 

Continued Dr. Spana, “The strong data from this Phase 2 study, along with the positive Phase 1 findings and robust preclinical data, provides meaningful evidence to support the advancement of a melanocortin-1 receptor agonist as a potential treatment for ulcerative colitis. Several major pharmaceutical companies have shown strong interest in our UC program, and we believe these positive Phase 2 results in PL8177 treated patients, for the critical efficacy endpoints of both clinical remission and clinical response, could help solidify a potential licensing deal.”

 

The Phase 2 PL8177 study was a multi-center, randomized, double-blind, placebo-controlled, adaptive design, parallel group of PL8177, with once daily oral dosing in adult UC subjects for 8 weeks. The study originally planned to enroll up to 28 patients, with an interim analysis after 12-16 participants. Due to a shift in strategic focus, Palatin stopped enrollment at 12 patients to accelerate out-licensing discussions and also to redirect resources to development of its melanocortin obesity assets. As a result of lower patient numbers, the study was not powered to show statistical significance.

 

Details about the trial can be found at clinicaltrials.gov under the identifier NCT05466890. Additional findings are expected to be shared at an upcoming scientific conference.

 

Ulcerative colitis is a form of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining.1 Patients often experience a range of unpredictable symptoms that impact their daily lives, such as abdominal pain, bloody stool and urgency to use the bathroom.2,3 The disease course varies between patients, and in some cases can lead to surgery or complications, including cancer or death.3,4

 

Orally administered PL8177 is designed to target melanocortin-1 receptors on the surface of cells lining the colon. In a Phase 1 clinical trial, the oral version of PL8177 was shown to effectively reach the colon and remain without spreading throughout the rest of the body.

 

 

-More-

 

 

The Company’s Phase 2 trial for ulcerative colitis builds on previous research with oral PL8177. Earlier studies showed that the drug helps improve colon health by increasing the number of important colon cells. The treatment also helped reduce harmful inflammation by changing certain immune cells from promoting inflammation to helping resolve it.

 

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 PL8177

PL8177 is a synthetic cyclic heptapeptide with demonstrated efficacy in multiple animal inflammatory bowel disease models. PL8177 is a potent, selective agonist at the human melanocortin-1 receptor (MC1R), with sub-nanomolar affinity binding and EC50 functional values. Palatin data demonstrates that their oral formulation of PL8177 was protected from degradation in the stomach and small intestine of humans and delivered to the colon over an extended period. In addition, orally administered PL8177 had a significant effect on resolving inflammation in a rat bowel inflammation model.

 

PL8177 in oral formulations has demonstrated repeated, robust efficacy in ulcerative colitis disease models. MC1R is found on epithelial cells and resident macrophages of the colon which are accessible from the lumen of the colon. Orally administered PL8177 is not systemically absorbed. PL8177 has the potential for excellent efficacy without safety concerns.

 

About Ulcerative Colitis

Ulcerative colitis is a chronic disease of the large intestine (colon), with inflammation and ulcerations that can cause significant abdominal pain, persistent diarrhea, loss of appetite and other symptoms. An estimated 1.25 million individuals in the United States are affected by ulcerative colitis, with over 350,000 diagnosed with moderate-to-severe disease.¹ Existing treatments are not effective in a substantial portion of patients with moderate-to-severe ulcerative colitis, with certain severe cases resulting in surgical removal of the colon.

 

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.

 

 

-More-

 

 

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.

 

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

Palatin Technologies® is a registered trademark of Palatin Technologies, Inc.

 

1 Lewis JD, Parlett LE, Jonsson Funk ML, et al. Incidence, prevalence, and racial and ethnic distribution of inflammatory bowel disease in the United States. Gastroenterology. 2023;165(5). doi:10.1053/j.gastro.2023.07.003.

2 The Facts about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation of America. 2014. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf. Accessed June 2024.

3 Ulcerative colitis. Mayo Clinic. 2022. Available at: https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326. Accessed June 2024.

4 Monstad, I, Hovde O, Solberg IC, A Moum B. Clinical course and prognosis in ulcerative colitis: results from population-based and observational studies. Ann Gastroenterol. 2014;27(2):95-104.

 

 

###

 

EX-99.2 3 ptn_ex992.htm PRESS RELEASE ptn_ex992.htm

EXHIBIT 99.2

 

Palatin AnnouncesMC4R Agonist Bremelanotide Co-Administered with

GLP-1/GIP Tirzepatide Meets Primary Endpoint in Phase 2 Obesity Study

 

 

·

Primary endpoint met in the 8-week treatment study (highly statistically significant).

 

 

o

Co-administered group had a 4.4% reduction in weight compared to 1.6% for the placebo group (p<0.0001).

 

·

Primary analysis for the co-administered group in the 8-week treatment study showed:

 

 

o

40% of patients achieved 5% reduction in weight (p<0.05).

 

 

o

27% achieved 6% reduction in weight (p<0.05).

 

 

o

19% achieved 7% reduction in weight (p<0.1).

 

·

Low dose bremelanotide arm stopped weight regain seen post tirzepatide treatment.

 

·

Novel next-generation MC4R long-acting peptides and oral small molecules:

 

 

o

IND applications planned for 4Q25; clinical data expected 1H26.

 

 

 

Phase 1 SAD/MAD studies to include hypothalamic obesity patients.

 

CRANBURY, NJ – March 31, 2025 /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 that its BMT-801 Phase 2 obesity co-administration study met its primary endpoint and was highly statistically significant. The Company reported positive topline data with co-administered melanocortin-4 receptor (MC4R) agonist bremelanotide plus glucagon like peptide-1/gastric inhibitory polypeptide (GLP-1/GIP) tirzepatide and highlighted next steps in its obesity program for its novel next-generation MC4R long-acting peptides and oral small molecules.

 

“Although the study was not designed to optimize weight loss, this 8-week study utilizing low doses of both bremelanotide and tirzepatide, met the primary endpoint and was highly statistically significant,” said Carl Spana, Ph.D., President & Chief Executive Officer of Palatin. “The positive results of this signal-generating study exceeded expectations. The data demonstrated that co-administration was additive and synergistic, resulting in increased weight loss, and that co-administration did not result in increased tolerability or safety issues for patients. The data also showed that low dose MC4R agonist bremelanotide stopped the rapid weight regain seen after ending GLP-1/GIP tirzepatide treatment.”

 

Topline data results from the study were highly statistically significant for the study’s primary endpoint, which was percent weight loss in patients for the co-administration of MC4R agonist bremelanotide plus GLP-1/GLP tirzepatide compared to placebo, over the 8-week treatment period.

 

 

·

The co-administered group had a 4.4% reduction in weight compared to 1.6% for the placebo group (p<0.0001).

 

The primary analysis for additive effect demonstrated that:

 

 

·

40% of patients in the co-administered group achieved a 5% reduction in their body weight, compared to 27% for the tirzepatide alone group (p<0.05).

 

·

27% of patients in the co-administered group achieved a 6% reduction in their body weight, compared to 13% for the tirzepatide alone group (p<0.05).

 

·

19% of patients in the co-administered group achieved a 7% reduction in their body weight, compared to 0% for the tirzepatide alone group (p<0.1).

 

·

Increase in the percent of subjects on co-administration achieving 5%, 6% and 7% weight loss over tirzepatide alone, indicates that co-administration had a synergistic effect.

 

 

-More-

 

 

“This study provides compelling evidence that combining an MC4R agonist with a GLP-1/GIP compound creates a synergistic effect on weight loss,” said Jesse Richards, DO, of Oklahoma State University College of Osteopathic Medicine. “These findings align with what we observe in our clinic, where we treat patients with severe genetic obesity using both mechanisms. With a critical need for diverse weight loss solutions, this approach offers a promising improvement to GLP-1/GIP monotherapy, particularly for those who struggle with tolerability at high doses.”

 

In the study, patients first received a four-week treatment with tirzepatide alone (2.5 mg weekly) to confirm eligibility. They were then randomly assigned to one of four treatment groups for an additional four weeks: co-administration of MC4R bremelanotide (1.25 mg daily) and GLP-1/GIP tirzepatide (2.5 mg weekly), tirzepatide alone (2.5 mg weekly), bremelanotide alone (1.25 mg daily), or a placebo. A total of 113 patients were enrolled, with 96 randomized in a 3:1 ratio. Specifically, 46 patients were assigned to the MC4R plus GLP-1/GIP co-administration group, while the remaining arms had 15 to 16 patients each.

 

More than 50% of the lost weight was regained within two weeks after treatment cessation in both the co-administration group and the tirzepatide-only group, a common occurrence following the discontinuation of GLP-1/GIP therapy. Importantly, the data indicated that weight regain was effectively halted in the MC4R agonist bremelanotide group. Additionally, co-administration of the MC4R agonist with the GLP-1/GIP therapy showed no increase in safety or tolerability concerns among patients.

 

Further data analysis is ongoing, including exploratory endpoints such as body composition and body mass index (BMI). The complete study results will be presented at an upcoming medical conference. Additional trial details can be accessed at https://clinicaltrials.gov using the identifier NCT06565611.

 

Palatin is advancing the development of its next-generation MC4R long-acting peptide and oral small molecule compounds for the treatment of general obesity, weight loss management, acquired and congenital hypothalamic obesity, and potentially, rare/orphan genetically caused MC4R pathway diseases. These therapies are being explored as stand-alone treatments, as well as in combination with GLP-1/GIP (incretin therapy), and as monotherapy for multiple genetic obesity disorders. Investigational New Drug (IND) applications are expected to be submitted in the fourth quarter of calendar 2025, with clinical data expected in the first half of calendar year 2026.

 

“We see hypothalamic obesity as a game-changing opportunity for Palatin, addressing a massive unmet medical need in a multi-billion-dollar market with no approved treatments,” continued Dr. Spana. “Importantly, we are one of only two companies pioneering therapies that specifically target the MC4R pathway. Our highly selective, long-acting compounds—MC4R agonist peptides and the oral small molecule agonist PL7737—are designed to redefine treatment standards. Leveraging our deep expertise in MC4R agonist interactions, we have engineered these compounds to overcome critical challenges, including hyperpigmentation, hypertensive effects, the need for daily injections, and gastrointestinal side effects.”

 

While GLP-1 receptor agonists are widely used to treat obesity, alternative treatments are necessary due to several drawbacks — 67% of patients discontinue treatment because of side effects and a plateau effect in the first year. These medications can cause adverse side effects, be cost-prohibitive, lead to long-term reliance, and frequently result in weight regain upon discontinuation. MC4R agonists represent a validated pathway and promising therapeutic option for addressing obesity and promoting sustained weight management.

 

 

-More-

 

 

About Melanocortin-4 Receptor Agonists Effect on Obesity

Genetic analysis has identified the melanocortin-4 receptor (MC4R) of the paraventricular nucleus of the hypothalamus as playing a central role in appetite regulation. Genetic mutations that inhibit signaling in 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. Agouti-related peptide is an endogenous antagonist of the MC4R that works with neuropeptide Y to stimulate appetite, whereas MC4R agonists such as α- and β-melanocyte-stimulating hormone promote satiety. MC4R agonism represents an attractive target for potential obesity treatments.

 

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 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, 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.

 

Investor Inquiries:

Media Inquiries:

Stephen T. Wills, CPA, MST

Paul Arndt, MBA, LifeSci Advisors, LLC

Chief Financial Officer / Chief Operating Officer

Managing Director

Tel: (609) 495-2200

Tel: (646) 597-6992

Info@Palatin.com

Paul@LifeSciAdvisors.com

 

 

###