Financial Data and Key Metrics Changes - Revenue for the second quarter was $116,000, compared to $0 in the same period last year, primarily from cost reimbursements under a collaboration agreement with Boehringer Ingelheim [6] - Total operating expenses increased to $7.4 million from $2.6 million in the prior year, driven by higher investments in obesity development programs and increased compensation costs [6][7] - Net loss for the quarter was $7.3 million, or $2.86 per share, compared to a net loss of $2.4 million, or $5.92 per share in the comparable period last year [8] - Cash and cash equivalents as of December 31, 2025, were $14.5 million, up from $1.3 million at September 30, 2025 [9] Business Line Data and Key Metrics Changes - The company is advancing its melanocortin-4 receptor-based obesity pipeline, focusing on rare syndromic and genetic obesity disorders [10] - The lead oral small molecule MC4R agonist, PL7737, is progressing through IND-enabling toxicology studies, with an IND submission planned for the first half of 2026 [11] - Next-generation selective melanocortin-4 receptor peptide agonists are also being developed, with an IND submission planned for the second half of 2026 [11] Market Data and Key Metrics Changes - The company regained compliance with NYSE American listing standards, and its common stock resumed trading under the symbol PTN [5][13] - The focus remains on rare neuroendocrine obesity disorders, including hypothalamic obesity and Prader-Willi syndrome, which represent significant unmet medical needs [10][12] Company Strategy and Development Direction - The company aims to deliver differentiated product profiles with a focus on enhancing patient tolerability and minimizing off-target effects [11] - A sub-licensing transaction for PL9643 provided approximately $3.8 million in upfront consideration, allowing the company to sharpen its focus on core obesity programs [12][13] - The company is positioned to pursue substantial long-term value creation through multiple partnerships and near-term milestones [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the differentiation of their products, particularly regarding tolerability and safety profiles compared to existing treatments [17][34] - The company anticipates moving forward into phase II studies for both oral small molecules and long-acting peptides targeting hypothalamic obesity and Prader-Willi syndrome patients by mid-2027 [43] Other Important Information - The company completed an $18.2 million public offering, which significantly strengthened its balance sheet and provided capital for advancing its obesity pipeline [5][10] - The company expects its cash runway to extend beyond the quarter ending March 31, 2027 [9] Q&A Session Summary Question: What preclinical or translational signals give confidence in differentiation for PL7737? - Management highlighted the design of the compound to be more selective for the melanocortin-4 receptor, which should reduce hyperpigmentation and control GI side effects [17] Question: How will patient selection and endpoints be approached in the phase one study? - The focus will be on safety and confirming oral absorption, with weight reduction and control of hyperphagia as key parameters in the multiple-ascending dose study [19][20] Question: Is there an increased emphasis on Prader-Willi syndrome? - Management confirmed that while Prader-Willi has always been in the background, they are focusing on indications with substantial patient populations [21][22] Question: How will the oral small molecule and weekly injection be positioned? - Both products are seen as complementary, with each suited for different patient populations [24][25] Question: What is the anticipated cash flow and resource allocation for PWS studies? - Management indicated sufficient cash to move forward with both oral and peptide studies, with plans to initiate studies in PWS patients by mid-2027 [43] Question: How will GLP-1 therapies be integrated into product development? - Management anticipates that combination therapies will be necessary for optimizing treatment, particularly for patients with severe hyperphagia [48]

Financial Data and Key Metrics Changes - Revenue for the second quarter was $116,000, compared to $0 in the same period last year, primarily from cost reimbursements under a collaboration agreement with Boehringer Ingelheim [6] - Total operating expenses increased to $7.4 million from $2.6 million in the prior year, driven by higher investments in obesity development programs and increased compensation costs [6][7] - Net loss for the quarter was $7.3 million, or $2.86 per share, compared to a net loss of $2.4 million, or $5.92 per share in the comparable period last year [8] - Cash and cash equivalents as of December 31, 2025, were $14.5 million, up from $1.3 million at September 30, 2025 [9] Business Line Data and Key Metrics Changes - The company is advancing its melanocortin-4 receptor-based obesity pipeline, focusing on rare syndromic and genetic obesity disorders [10] - The lead oral small molecule MC4R agonist, PL7737, is progressing through IND-enabling toxicology studies, with an IND submission planned for the first half of 2026 [11] - The next generation selective melanocortin-4 receptor peptide agonists are also being developed, with an IND submission planned for the second half of 2026 [11] Market Data and Key Metrics Changes - The company has regained compliance with NYSE American listing standards, and its common stock resumed trading under the symbol PTN [5][13] - The focus remains on rare neuroendocrine obesity disorders, including hypothalamic obesity and Prader-Willi syndrome, which represent significant unmet medical needs [10][12] Company Strategy and Development Direction - The company aims to deliver differentiated product profiles with a focus on enhancing patient tolerability and minimizing off-target effects [11] - A strategic shift was made by sub-licensing the dry eye disease clinical candidate, PL9643, to focus more on core obesity programs [12][13] - The company is positioned to pursue long-term value creation through multiple partnerships and a focused pipeline [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the differentiation of their products, particularly regarding tolerability and safety profiles compared to current treatments [17][34] - The company anticipates moving into phase II studies for Prader-Willi syndrome and hypothalamic obesity patients by mid-2027 [43] - Management highlighted the importance of combination therapies with GLP-1 based treatments as the market evolves [48] Other Important Information - The company completed a public offering of $18.2 million, strengthening its balance sheet and providing capital for advancing obesity programs [5][10] - The company expects its cash runway to extend beyond March 31, 2027, based on current operating plans [9] Q&A Session Summary Question: What preclinical signals give confidence in differentiation for PL7737? - Management highlighted the design of the compound to be more selective for the melanocortin-4 receptor, which should reduce hyperpigmentation and control GI side effects [17] Question: How will patient selection and endpoints be defined for phase one studies? - The focus will be on safety and confirming oral absorption, with weight reduction and control of hyperphagia as key metrics in the multiple-ascending dose study [19][20] Question: Is there an increased emphasis on Prader-Willi syndrome? - Management confirmed that while it has always been in the background, there is a focus on larger indications like hypothalamic obesity and Prader-Willi syndrome due to the number of patients [22] Question: How will the oral small molecule and weekly injection be positioned? - Both products are seen as complementary, with each suited for different patient populations [24][25] Question: What is the anticipated cash flow for the next quarters? - Management indicated that there were one-time extraordinary expenses in the previous quarter, and they expect operating expenses to decrease in the upcoming quarters [27][28]

Financial Data and Key Metrics Changes - Revenue for Q2 2026 was $116,000, compared to $0 in the same period last year, attributed to cost reimbursements from a collaboration with Boehringer Ingelheim [7] - Total operating expenses increased to $7.4 million from $2.6 million in the prior year, primarily due to higher investments in obesity development programs and increased compensation costs [7] - Net loss for the quarter was $7.3 million, or $2.86 per share, compared to a net loss of $2.4 million, or $5.92 per share in the prior year [8] - Cash and cash equivalents as of December 31, 2025, were $14.5 million, up from $1.3 million at September 30, 2025 [10] Business Line Data and Key Metrics Changes - The company is advancing its melanocortin-4 receptor-based obesity pipeline, focusing on rare syndromic and genetic obesity disorders [11] - The lead oral small molecule MC4R agonist, PL7737, is progressing through IND-enabling toxicology studies, with plans to submit an IND in the first half of 2026 [12] - A next-generation selective melanocortin-4 receptor peptide agonist is also in development, with an IND submission planned for the second half of 2026 [12] Market Data and Key Metrics Changes - The company regained compliance with NYSE American listing standards, allowing its common stock to resume trading under the symbol PTN [6][14] - The focus remains on rare neuroendocrine obesity disorders, including hypothalamic obesity and Prader-Willi syndrome, which represent significant unmet medical needs [12] Company Strategy and Development Direction - The company aims to deliver differentiated product profiles with a focus on enhancing patient tolerability and minimizing side effects [12] - A strategic sub-licensing of PL9643 for dry eye disease has allowed the company to sharpen its focus on core obesity programs while retaining potential future financial participation [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position and pipeline, indicating that the successful public offering has provided the necessary capital to advance obesity programs [11][14] - The company anticipates a cash runway extending beyond March 31, 2027, based on current operating plans [10] Other Important Information - The company received approximately $3.8 million in upfront consideration from the sublicensing transaction, which will be recognized as licensed revenue in the quarter ending March 31, 2026 [10] Q&A Session Summary Question: What preclinical or translational signals give confidence in differentiation for PL7737? - The compound is designed to be more selective for the melanocortin-4 receptor, which should reduce hyperpigmentation and control GI side effects through its administration [17][18] Question: How will patient selection and endpoints be approached in the phase one study? - The phase one studies will primarily focus on safety, with the multiple-ascending dose study looking for reductions in body weight and control of hyperphagia [19][20] Question: Is there an increased emphasis on Prader-Willi syndrome? - Prader-Willi syndrome has always been in the background, but the company is focusing on larger indications with substantial patient populations [22] Question: How will the oral small molecule and weekly injection be positioned? - Both products are seen as complementary, with each suited for different patient populations [24][26] Question: What is the anticipated impact of GLP-1 therapies on product development? - The company is exploring combination therapies with GLP-1s to optimize treatment for patients with severe hyperphagia [49]

S-1/A 1 ptn_s1a.htm FORM S-1/A As filed with the Securities and Exchange Commission on October 17, 2025. Registration No. 333-290641 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Palatin Technologies, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 95-4078 ...

S-1 1 ptn_s1.htm FORM S-1 As filed with the Securities and Exchange Commission on September 30, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Palatin Technologies, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 95-4078884 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identif ...

Financial Data and Key Metrics Changes - For the fiscal third quarter ended March 31, 2025, Palatin reported total operating expenses of $4.8 million, a decrease from $9.2 million in the same quarter last year, primarily due to reduced spending on MCR programs [6][7] - The net loss for the quarter was $4.8 million, down from $8.4 million for the same period in 2024, driven by decreased operating expenses [7] - Cash and cash equivalents as of March 31, 2025, were $2.5 million, down from $9.5 million as of June 30, 2024 [8] Business Line Data and Key Metrics Changes - Palatin did not record any product sales for the quarter due to the completion of the sale of Vyleesi's worldwide rights for up to $171 million in December 2023 [6] - Positive top-line data was reported for the Phase II study of the melanocortin-four receptor obesity program, showing a weight reduction of 4.4% for the combined treatment compared to 1.6% for the placebo [10] - The Phase II study of PL-8177 for ulcerative colitis showed clinical remission in 33% of treated patients versus 0% for placebo, indicating significant efficacy [12] Market Data and Key Metrics Changes - The company is actively engaged in business development discussions for its obesity and ulcerative colitis programs, which aligns with its strategy to out-license these programs [12][13] - The pharmacological treatment of obesity is expected to enter a multi-year cycle of innovation, with a market value projected to exceed $100 billion annually [15] Company Strategy and Development Direction - The company is focusing its R&D efforts on melanocortin-four receptor obesity assets, believing they will play a critical role in future obesity treatment [15] - The next-generation melanocortin-four receptor compounds aim to eliminate skin darkening side effects and improve dosing convenience, with a goal of once-weekly or once-daily administration [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment over the NYSE's decision to suspend trading and delist the company's stock, indicating they are assessing all available options [5] - The management believes the recent positive clinical data will enhance business development opportunities and is optimistic about future partnerships [12][14] Other Important Information - The company is actively seeking multiple funding sources to address future operating cash requirements [8] - The FDA granted orphan drug status to PL-7737 for treating obesity due to leptin receptor deficiency, which is expected to support its development [11] Q&A Session Summary Question: Will a higher dose of remelanotide increase weight loss? - Management indicated that higher doses of bremelanotide have been studied and can achieve weight loss comparable to single-agent treatments like Wegovy [17] Question: Will weight maintenance become a focus in future generations of treatments? - Management confirmed that newer compounds will be evaluated for long-term weight maintenance, addressing the rebound weight regain issue [19][20] Question: What benefits will the next generation of MC4Rs have over the first generation? - Management highlighted that the next generation aims to eliminate pigmentation issues and improve dosing frequency, making them more competitive in the market [21][22]

Financial Data and Key Metrics Changes - For Q2 2025, Palatin did not record any product sales due to the sale of Vyleesi's rights, compared to gross product sales of $4.3 million and net product revenue of $2 million in Q2 2024 [4] - Total operating expenses for Q2 2025 were $2.6 million, net of a $2.5 million gain, compared to $900,000 net of a $7.8 million gain in Q2 2024 [4] - Net loss for Q2 2025 was $2.4 million, a decrease from a net loss of $7.8 million in Q2 2024, primarily due to changes in fair values of warrant liabilities and the elimination of leasing net product revenue [5] - Cash and cash equivalents as of December 31, 2024, were $3.4 million, an increase from $2.4 million at September 30, 2024, but down from $9.5 million at June 30, 2024 [5][6] Business Line Data and Key Metrics Changes - The Phase two study BMP-801 evaluating the co-administration of bremelanotide with drocepatide has been completed, with top-line data expected later this month [7][8] - The obesity and weight loss management portfolio includes long-acting and orally active melanocortin four receptor compounds, with plans to move both into IND enabling activities and clinical studies in 2025 [9] - A Phase two study for OP08177 for ulcerative colitis remains on track for top-line data release in Q1 2025, with increased business development discussions anticipated [10] Market Data and Key Metrics Changes - The pharmacological treatment of obesity is projected to have a market value exceeding $100 billion annually, with a focus on melanocortin four receptor agonists as a key treatment option [12] - The company is exploring opportunities in rare and orphan syndromic diseases, which may present significant market potential [22][23] Company Strategy and Development Direction - The company is concentrating its R&D efforts on melanocortin four receptor obesity assets, believing it will play a crucial role in future obesity treatment [12] - Palatin is actively engaged in discussions for out-licensing programs and seeking funding for further development [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming quarter and 2025, highlighting the excitement surrounding their ongoing projects and potential market opportunities [28] Other Important Information - The detailed results of the Phase two breakout study for Bremelanotide in diabetic kidney disease have been accepted for presentation at a medical meeting, indicating the program's potential [10][11] Q&A Session Summary Question: Focus on upcoming obesity data and benchmarks - Management clarified that they are looking for a clear signal in the study rather than a specific percentage weight loss benchmark, emphasizing the importance of clinical meaningfulness [15][16][17] Question: Consideration of additional indications beyond weight loss - Management acknowledged the potential for melanocortin four receptor agonists in rare and orphan syndromic diseases, indicating a strategic focus on this area [21][22][24]