Palatin Reports First Quarter Fiscal Year 2025 Operating/Financial Results
Palatin Technologies (NYSE: PTN) reported Q1 FY2025 financial results and provided updates on its obesity programs. The company completed patient enrollment in October 2024 for its Phase 2 BMT-801 clinical study, combining MC4R agonist bremelanotide with GLP-1/GIP dual agonist tirzepatide, with topline results expected in Q1 2025. Net loss for Q1 was $7.8 million ($0.39 per share), compared to $5.2 million ($0.43 per share) in Q1 FY2024. Cash position as of September 30, 2024, was $2.4 million. The company has engaged an investment bank to explore strategic options for non-obesity programs, including its Phase 3 DED program and Phase 2 UC program.
Palatin Technologies (NYSE: PTN) ha riportato i risultati finanziari del Q1 FY2025 e fornito aggiornamenti sui suoi programmi contro l'obesità. L'azienda ha completato l'arruolamento dei pazienti nell'ottobre 2024 per il suo studio clinico di Fase 2 BMT-801, che combina l'agonista MC4R bremelanotide con l'agonista duale GLP-1/GIP tirzepatide, con risultati preliminari attesi per il Q1 2025. La perdita netta per il Q1 è stata di 7,8 milioni di dollari (0,39 dollari per azione), rispetto ai 5,2 milioni di dollari (0,43 dollari per azione) del Q1 FY2024. La posizione di cassa al 30 settembre 2024 era di 2,4 milioni di dollari. L'azienda ha ingaggiato una banca d'investimento per esplorare opzioni strategiche per programmi non legati all'obesità, inclusi il suo programma DED di Fase 3 e il programma UC di Fase 2.
Palatin Technologies (NYSE: PTN) informó los resultados financieros del Q1 FY2025 y ofreció actualizaciones sobre sus programas de obesidad. La compañía completó la inscripción de pacientes en octubre de 2024 para su estudio clínico de Fase 2 BMT-801, combinando el agonista MC4R bremelanotida con el agonista dual GLP-1/GIP tirzepatida, con resultados preliminares esperados para el Q1 2025. La pérdida neta del Q1 fue de 7,8 millones de dólares (0,39 dólares por acción), en comparación con 5,2 millones de dólares (0,43 dólares por acción) en el Q1 FY2024. La posición de efectivo a fecha del 30 de septiembre de 2024 era de 2,4 millones de dólares. La compañía ha contratado a un banco de inversión para explorar opciones estratégicas para programas no relacionados con la obesidad, incluidos su programa DED de Fase 3 y el programa UC de Fase 2.
팔라틴 테크놀로지스 (NYSE: PTN)는 FY2025 1분기 재무 결과를 발표하고 비만 프로그램에 대한 업데이트를 제공했습니다. 이 회사는 MC4R 효능제인 브레멜라노타이드와 GLP-1/GIP 이중 효능제인 티르제파타이드를 결합한 Phase 2 BMT-801 임상 연구의 환자 등록을 2024년 10월에 완료했으며, 주요 결과는 2025년 1분기에 예상됩니다. 1분기 순손실은 780만 달러 (주당 0.39달러)였으며, 이는 FY2024 1분기의 520만 달러 (주당 0.43달러)에 비해 증가한 수치입니다. 2024년 9월 30일 기준 현금 보유액은 240만 달러였습니다. 회사는 비만 관련 프로그램이 아닌 전략적 옵션을 탐색하기 위해 투자은행을 고용했습니다. 이에는 3상 DED 프로그램 및 2상 UC 프로그램이 포함됩니다.
Palatin Technologies (NYSE: PTN) a publié les résultats financiers du T1 FY2025 et fourni des mises à jour sur ses programmes contre l'obésité. La société a terminé le recrutement des patients en octobre 2024 pour son étude clinique de Phase 2 BMT-801, combinant l'agoniste MC4R bremelanotide avec l'agoniste dual GLP-1/GIP tirzepatide, avec des résultats préliminaires attendus pour le T1 2025. La perte nette pour le T1 s'élevait à 7,8 millions de dollars (0,39 dollar par action), contre 5,2 millions de dollars (0,43 dollar par action) au T1 FY2024. La position de trésorerie au 30 septembre 2024 était de 2,4 millions de dollars. La société a engagé une banque d'investissement pour explorer des options stratégiques pour ses programmes non liés à l'obésité, y compris son programme DED de Phase 3 et son programme UC de Phase 2.
Palatin Technologies (NYSE: PTN) hat die finanziellen Ergebnisse des Q1 FY2025 veröffentlicht und Updates zu seinen Programmen gegen Fettleibigkeit bereitgestellt. Das Unternehmen hat im Oktober 2024 die Patientenaufnahme für seine klinische Studie der Phase 2 BMT-801 abgeschlossen, die den MC4R-Agonisten Bremelanotid mit dem GLP-1/GIP-Dualagonisten Tirzepatid kombiniert. Die ersten Ergebnisse werden im Q1 2025 erwartet. Der Nettoverlust für das Q1 betrug 7,8 Millionen USD (0,39 USD pro Aktie), verglichen mit 5,2 Millionen USD (0,43 USD pro Aktie) im Q1 FY2024. Die Liquiditätsposition zum 30. September 2024 betrug 2,4 Millionen USD. Das Unternehmen hat eine Investmentbank beauftragt, strategische Optionen für Programme, die nicht mit Fettleibigkeit zu tun haben, zu prüfen, einschließlich seines Phase-3-DED-Programms und des Phase-2-UC-Programms.
- Completed patient enrollment for Phase 2 BMT-801 obesity study with approximately double the target patient number
- Received $2.5 million deferred upfront payment in November 2024 from Vyleesi sale
- Potential milestone payments of up to $159 million from Vyleesi sale based on future sales performance
- Net loss increased to $7.8 million in Q1 FY2025 from $5.2 million in Q1 FY2024
- Cash position decreased to $2.4 million from $9.5 million in June 2024
- No product revenue recorded in Q1 FY2025 compared to $2.1 million net product revenue in Q1 FY2024
- Increased cash burn with net cash used in operations rising to $7.0 million from $5.9 million year-over-year
Insights
Q1 FY2025 shows concerning financial metrics with
Key developments include completed enrollment in the BMT-801 obesity study with results expected Q1 2025 and potential milestone payments up to
The obesity program strategy shows promise, particularly the BMT-801 study combining MC4R agonist with tirzepatide. The doubled enrollment indicates strong patient interest and could provide robust data. The MC4R pathway approach differentiates from current GLP-1 treatments, potentially addressing the
The development of both long-acting peptides and oral small molecules provides multiple shots on goal. However, with multiple clinical trials planned for 2025, significant capital will be required. While the scientific approach is sound, particularly in targeting treatment-resistant obesity and rare diseases, the company's cash position may impact execution of this ambitious development timeline.
- Obesity programs:
- Core focus on obesity includes exploratory co-administration BMT-801 study and two novel development drug candidates
- Phase 2 BMT-801 clinical study with MC4R agonist bremelanotide plus GLP-1/GIP dual agonist tirzepatide
- Patient enrollment completed October 2024
- Topline results expected 1Q calendar year 2025
- Multiple clinical trials targeted in calendar year 2025 with long-acting MC4R peptide and oral small molecule compounds
- General obesity, weight loss management, and rare MC4R pathway diseases like hypothalamic obesity
- Dry eye disease (DED) and other ocular programs, ulcerative colitis (UC), male sexual dysfunction, and diabetic nephropathy programs:
- Investment bank engaged as a financial advisor to explore strategic options for non-obesity programs
- Teleconference and Webcast to be held on November 14, 2024, at 11:00 AM ET
"With the establishment of pharmacotherapy as the primary treatment for the millions of obese patients and the high discontinuation rate (
Dr. Spana noted, "We believe focusing on our core and most valuable programs in obesity is the right course of action for the long-term success of Palatin. We have retained an investment bank to conduct, explore, and evaluate strategic options for our non-obesity programs. At this stage, there has been significant interest in and ongoing discussions for our Phase 3 DED program, early-stage glaucoma and retina development programs, and our Phase 2 UC program from multiple parties."
The MC4R pathway plays a key role in the regulation of energy storage and food intake. The novel MC4R selective agonists being developed by Palatin could potentially play a vital role in treating obesity as monotherapy and/or combination therapy.
Program Updates and Anticipated Milestones
Obesity Programs:
- Phase 2 BMT-801 clinical study for the co-administration of melanocortin agonist bremelanotide (MC4R) with tirzepatide (GLP-1/GIP dual agonist) in obese patients:
- Patient enrollment completed October 2024
- The study enrolled approximately twice the target of 60 patients at four sites in the
U.S , primarily due to strong patient demand and efficiency of the clinical trial sites- Primary endpoint: Demonstrate the safety and increased efficacy of co-administration of bremelanotide with tirzepatide on reducing body weight
- Patients will be treated with tirzepatide-only for four weeks, have eligibility confirmed, then randomized to one of four treatment arms
- Patients will undergo multiple assessments of safety and efficacy to help profile the effectiveness of bremelanotide in treating general obesity as a stand-alone treatment or in conjunction with GLP-1 therapy
- Topline results expected in 1Q calendar year 2025
- Additional trial information, including inclusion and exclusion criteria, can be found at https://clinicaltrials.gov via the identifier NCT06565611
- Presented a poster titled "Structural Modification Allows the Removal of Melanocortin Receptor 1 Agonism From Melanocortin Receptor 4 Agonists," at the 19th Annual Peptide Therapeutics Symposium in October 2024:
- MC4R selectivity significantly reduces potential for skin pigmentation
- Presented data on novel melanocortin-4 receptor selective oral small molecule PL7737 obesity program at ObesityWeek® 2024 in November 2024:
- Oral PL7737 significantly decreased food intake and body weight
- Novel MC4R selective long-acting peptide and oral small molecule agonists:
- Potential for monotherapy or combination (with a GLP-1 agonist) therapy
- Initiation of investigational new drug (IND) enabling activities expected to commence 1Q calendar year 2025
- Filing of INDs anticipated 2H of calendar year 2025
- Commencement of Phase 1 clinical studies targeted for 4Q of calendar year 2025
Ocular Programs (melanocortin receptor agonists):
- Phase 3 PL9643 clinical program for the treatment of dry eye disease (DED):
- MELODY-1 pivotal study successfully completed
- Statistical significance (p<0.025) met for co-primary symptom endpoint of pain
- Statistical significance (p<0.05) met for 7 of 11 secondary symptom endpoints at the 12-week treatment period
- Rapid onset of efficacy in multiple symptom endpoints at 2 weeks and continued improvement to 12 weeks with statistical significance (p<0.05) met
- Statistical significance (p<0.05) met for multiple sign endpoints, including 4 fluorescein staining endpoints at the 2-week treatment period
- Corneal fluorescein staining is used to measure corneal epithelial damage and reductions in corneal fluorescein staining with treatments like PL9643, indicating improvement in corneal health
- Excellent safety and tolerability profile
- MELODY-2 & MELODY-3 clinical studies
- Concluded positive Type C meeting with the FDA and reached agreement on sign and symptom endpoints for remaining two Phase 3 pivotal trial protocols
- Subject to funding, patient enrollment ready to begin 1Q calendar year 2025
- Potential collaboration and funding discussions ongoing
- Glaucoma (PL9588) and retina (PL9654) development programs
- Development candidates ready for IND-enabling toxicology studies
- Glaucoma drug candidate shows lack of adverse events and potential for neuroprotection as differentiating factors
- Retina drug candidate provides potential differentiating factors
- MELODY-1 pivotal study successfully completed
Male Sexual Dysfunction Program:
- Historical data show that approximately
35% of men with ED have an inadequate response to PDE5i treatments, which represents a large underserved market - Palatin previously conducted clinical trials showing the synergistic effects of combining bremelanotide with a PDE5i as a treatment for ED
- Palatin initiated a clinical development program for the evaluation of bremelanotide co-formulated with a PDE5 inhibitor (PDE5i) for the treatment of ED in patients that do not respond to PDE5i monotherapy:
- Subject to funding, pharmacokinetics (PK) study ready to start 1Q of calendar year 2025
- Patient recruitment in Phase 2/3 clinical study could start 2H calendar year 2025
- Subject to funding, pharmacokinetics (PK) study ready to start 1Q of calendar year 2025
Ulcerative Colitis Program (melanocortin receptor agonist):
- Phase 2 PL8177 oral formulation for the treatment of ulcerative colitis (UC):
- Enrollment near complete / interim analysis expected 1Q calendar year 2025
- Additional trial information, including inclusion and exclusion criteria, can be found at https://clinicaltrials.gov via the identifier NCT05466890
- Potential collaboration and funding discussions ongoing
Diabetic Nephropathy Program – The BREAKOUT Study (melanocortin receptor agonist):
- Phase 2 BREAKOUT study of bremelanotide (BMT 701) study in patients with diabetic kidney disease:
- Topline results expected 4Q calendar year 2024
- Additional trial information, including inclusion and exclusion criteria, can be found at https://clinicaltrials.gov via the identifier NCT05709444
Vyleesi® (bremelanotide injection) for Hypoactive Sexual Desire Disorder:
- Asset sale to Cosette Pharmaceuticals for up to
$171 million - Potential milestones of up to
$159 $15 million $200 million - Palatin retains rights to and use of bremelanotide for obesity and male ED
- Received
$2.5 million
- Potential milestones of up to
Fiscal First Quarter Ended September 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
Operating Expenses
Total operating expenses were
Other (Expense) / Income
Total other (expense) / income, net, consists mainly of foreign currency transaction (loss) and gains 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 through fiscal year ended June 30, 2024 to reflect changes in the fair value of these warrants. For the quarter ended September 30, 2023, Palatin recorded a fair value adjustment gain of
Cash Flows
Palatin's net cash used in operations for the quarter ended September 30, 2024, was
Net Loss
Palatin's net loss for the quarter ended September 30, 2024, was
The increase in net loss for the quarter ended September 30, 2024, over the quarter ended September 30, 2023, was mainly due to the elimination of Vyleesi net product revenue, offset by the elimination of Vyleesi selling expenses and the recognition of the change in fair value of warrant liabilities for the quarter ended September 30, 2023.
Cash Position
As of September 30, 2024, Palatin's cash and cash equivalents were
Palatin received a scheduled
The Company is actively engaged with multiple potential funding sources for future operating cash needs.
Conference Call / Webcast
Palatin will host a conference call and audio webcast on November 14, 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 176159. 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 51641. The webcast and telephone replay will be available through November 28, 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 September 30, | ||||
2024 | 2023 | |||
REVENUES | ||||
Product revenue, net | $ - | $ 2,105,977 | ||
OPERATING EXPENSES | ||||
Research and development | 5,743,754 | 5,014,630 | ||
Selling, general and administrative | 2,020,931 | 3,200,244 | ||
Total operating expenses | 7,764,685 | 8,214,874 | ||
Loss from operations | (7,764,685) | (6,108,897) | ||
OTHER (EXPENSE) INCOME | ||||
Investment income | 78,576 | 71,630 | ||
Foreign currency (loss) gain | (131,600) | 159,750 | ||
Interest expense | (5,940) | (10,882) | ||
Change in fair value of warrant liabilities | - | 682,400 | ||
Total other (expense) income, net | (58,964) | 902,898 | ||
NET LOSS | $ (7,823,649) | $ (5,205,999) | ||
Basic and diluted net loss per common share | $ (0.39) | $ (0.43) | ||
Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share | 19,845,106 | 12,170,699 | ||
PALATIN TECHNOLOGIES, INC. | |||
and Subsidiary | |||
Consolidated Balance Sheets | |||
(unaudited) | |||
September 30, 2024 | June 30, 2024 | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 2,384,214 | $ 9,527,396 | |
Prepaid expenses and other current assets | 228,435 | 242,272 | |
Total current assets | 2,612,649 | 9,769,668 | |
Property and equipment, net | 307,571 | 388,361 | |
Right-of-use assets - operating leases | 438,123 | 527,321 | |
Other assets | 56,916 | 56,916 | |
Total assets | $ 3,415,259 | $ 10,742,266 | |
LIABILITIES AND STOCKHOLDERS' (DEFICIENCY) EQUITY | |||
Current liabilities: | |||
Accounts payable | $ 3,949,028 | $ 4,101,929 | |
Accrued expenses | 4,573,292 | 4,185,046 | |
Short-term operating lease liabilities | 319,520 | 380,542 | |
Short-term finance lease liabilities | 18,527 | 46,014 | |
Other current liabilities | 1,001,350 | 944,150 | |
Total current liabilities | 9,861,717 | 9,657,681 | |
Long-term operating lease liabilities | 132,447 | 163,782 | |
Other long-term liabilities | 1,106,700 | 1,032,300 | |
Total liabilities | 11,100,864 | 10,853,763 | |
Stockholders' deficiency: | |||
Preferred stock of | |||
issued and outstanding designated as follows: | |||
Series A Convertible: authorized 4,030 shares as of September 30, 2024: | |||
issued and outstanding 4,030 shares as of September 30, 2024 and June 30, 2024 | 40 | 40 | |
Common stock of | |||
issued and outstanding 19,548,167 shares as of September 30, 2024 and 17,926,640 shares as of June 30, 2024 | 195,481 | 179,266 | |
Additional paid-in capital | 441,709,073 | 441,475,747 | |
Accumulated deficit | (449,590,199) | (441,766,550) | |
Total stockholders' deficiency | (7,685,605) | (111,497) | |
Total liabilities and stockholders' deficiency | $ 3,415,259 | $ 10,742,266 | |
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SOURCE Palatin Technologies, Inc.
FAQ
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