1. CRANBURY, N.J., Jan. 21, 2022 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor system, announced a presentation of the positive effects of PL8177 on treating ulcerative colitis in an animal disease model, including genomic data characterizing the anti-inflammatory effects of melanocortin agonists. The poster presentation of the efficacy and cellular and molecular effects of the melanocortin 1 receptor agonist PL8177 in a rat model of ulcerative colitis will be presented at the Crohn's and Colitis Congress, being held virtually, on January 21, 2022. 

    CRANBURY, N.J., Jan. 21, 2022 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor system, announced a presentation of the positive effects of PL8177 on treating ulcerative colitis in an animal disease model, including genomic data characterizing the anti-inflammatory effects of melanocortin agonists. The poster presentation of the efficacy and cellular and molecular effects of the melanocortin 1 receptor agonist PL8177 in a rat model of ulcerative colitis will be presented at the Crohn's and Colitis Congress, being held virtually, on January 21, 2022. 

    The data presented showed that orally administered PL8177 improved markers of colitis compared to the vehicle group. Also, data from colon samples from the DSS rat model showed significantly lower expression of a gene involved in regulating immune response in the bowel. These results support the aim of ultimately treating inflammatory bowel disease in humans. Palatin is planning to conduct a phase 2 clinical study evaluating PL8177 administered orally as a treatment for ulcerative colitis later this year.

    "The results of this ulcerative colitis study, including data from cutting edge genomic and proteomic platforms, are a demonstration of the excellent science our research team is doing, not only supporting Palatin's development programs, but also expanding knowledge about how melanocortins regulate inflammation," said Carl Spana, Ph.D., CEO and President of Palatin.

    Poster session details

    Session Title: Animal Models: Pre-Clinical Treatment of Intestinal Inflammation

    Session Date: Friday, January 21, 2022

    Session Time: 12–1 p.m. EASTERN STANDARD TIME (UTC -5)

    Presentation Title: CELLULAR AND MOLECULAR IMPACT OF THE MELANOCORTIN RECEPTOR AGONIST PL8177 IN DEXTRAN SODIUM SULFATE (DSS)-INDUCED COLITIS IN RATS

    Presentation Time: 12–1 p.m. EASTERN STANDARD TIME (UTC -5)

    The poster is available on Palatin's website at: www.palatin.com.

    About PL8177

    PL8177 is a synthetic cyclic heptapeptide with demonstrated efficacy in animal inflammatory bowel disease models. PL8177 is a potent agonist at the human melanocortin receptor-1 (MC1r), with sub-nanomolar affinity binding and EC50 functional values. Palatin data demonstrates that the oral formulation of PL8177 was protected from degradation in the stomach and small intestine and delivered to the large intestine and 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. Over 700,000 individuals in the United States are affected by ulcerative colitis, with over 350,000 diagnosed with moderate-to-severe disease. Existing treatments are not effective in a large portion of patients with moderate-to-severe ulcerative colitis, with some severe cases resulting in surgical removal of the colon.

    About Melanocortin Receptor Agonists and Inflammation

    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 and natriuretic peptide 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, such as statements about clinical trial plans and potential results for clinical or pre-clinical programs, 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 for events that occur after the date of this press release.

     

     

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  2. CRANBURY, N.J., Jan. 7, 2022 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor system, announced that the Company will present and host one-on-one meetings at the H.C. Wainwright BioConnect Virtual Conference being held January 10–13, 2022.

    Carl Spana, PhD, President and Chief Executive Officer will provide an update on the Company's pipeline, including the ongoing pivotal Phase 3 MELODY-1 study of PL9643 in patients suffering from dry eye disease.

    The Company's presentation will be available for on demand listening beginning at 7:00 a.m. ET on Monday, January 10, 2022, through the H.C. Wainwright BioConnect conference portal.

    To request a one-on-one meeting with Palatin during the conference, please contact your H.C. Wainwright representative or email .

    About Palatin

    Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide 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, such as statements about clinical trial plans and potential results for clinical or pre-clinical programs, 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 for events that occur after the date of this press release.

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  3. CRANBURY, N.J., Dec. 28, 2021 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor system, announced the initiation of the pivotal Phase 3 MELODY-1 clinical study of PL9643 in patients with dry eye disease. The study is designed to enroll up to 400 patients at multiple U.S. sites, and top-line results are currently expected second half calendar 2022.

    "We are excited to initiate the MELODY-1 study of PL9643 in patients suffering from dry eye disease," said Carl Spana, Ph.D., CEO and President of Palatin. "This is the second melanocortin peptide Palatin has advanced into Phase 3, demonstrating Palatin's expertise and efficiency in melanocortin peptide development for indications with unmet medical need."

    The pivotal Phase 3 MELODY-1 clinical study is a multi-center, randomized, double–masked and vehicle–controlled study evaluating the safety and efficacy of the melanocortin agonist, PL9643 ophthalmic solution, compared to vehicle in subjects with dry eye disease (DED). The study design is based on positive Phase 2 results of PL9643 for the treatment of dry eye disease, and an end-of-phase 2 (EOP2) meeting with the with the U.S. Food and Drug Administration (FDA), reaching agreement on all key elements of a pivotal Phase 3 clinical program, including study design, endpoints, interim assessment, and patient population. In addition, to support a New Drug Application (NDA) filing, a second phase 3 study (MELODY-2) and long-term safety study (MELODY-3) will be required. If the program progresses as planned, top-line results from MELODY-1 would be available second half calendar 2022, MELODY-2 data read out second half calendar 2023, with a potential NDA submission first half calendar 2024.

    "Progressing PL9643 into Phase 3 is a significant milestone for the Company and patients with DED," said Michael Raizman, MD, Chief Medical Officer of Palatin. "PL9643, with its differentiating factors, could provide a more tolerable and effective treatment option for patients suffering from dry eye disease."

    About Dry Eye Disease (DED)

    Dry eye disease is a common inflammatory disease that, left untreated, can become extremely painful and lead to permanent damage to the cornea and vision. Dry eye disease affects the cornea and conjunctiva of the eye resulting in irritation, redness, pain, and blurred vision. It is estimated to affect over 20 million people in the United States. The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Existing therapy for dry eye disease is generally regarded as inadequate by many physicians and patients, and often requires week or months to demonstrate activity.

    About Melanocortin Receptor Agonists and Inflammation

    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 and natriuretic peptide 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, such as statements about clinical trial plans and potential results for clinical or pre-clinical programs, 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 for events that occur after the date of this press release.

     

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  4. CRANBURY, N.J., Nov. 30, 2021 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor system, today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for application No.: 16/927,347. The allowed claims relate to the use of melanocortin peptides to decrease pro-inflammatory cytokine production and expression associated with cytokine storm, a dysregulation of the immune system characterized by undesired cytokine expression.

    Carl Spana, Ph.D., President and CEO of Palatin, stated, "We continue to strengthen our intellectual property surrounding our melanocortin receptor-1 peptide portfolio, particularly when early data suggest they can help resolve the over production and expression of pro-inflammatory cytokines associated with many diseases, including acute viral infections such as COVID-19. We continue to develop this technology as part of our diversified platform."

    This patent is in a family of patents relating to melanocortin receptor-1 peptides and covers additional intellectual property relating to use of high potency melanocortin receptor-1 peptides.

    About Melanocortins and Inflammation

    The melanocortin receptor ("MCr") system has effects on food intake, metabolism, sexual function, inflammation, and immune system responses. There are five melanocortin receptors, MC1r through MC5r. Modulation of these receptors, through receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have significant pharmacological effects.

    Many tissues and immune cells located in various organs such as the eye. gut, and kidney express melanocortin receptors, providing the 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 and natriuretic peptide 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.

    Forward-looking Statements

    Statements in this press release that are not historical facts, including statements about future expectations of Palatin, such as statements about clinical trial plans and potential results for clinical or pre-clinical programs, 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 for events that occur after the date of this press release.

     

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  5. CRANBURY, N.J., Nov. 15, 2021 /PRNewswire/ -- Palatin Technologies, Inc., (NYSE:PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor systems, today announced results for its first fiscal quarter ended September 30, 2021.

    "I am excited with the significant advancement of our melanocortin agonist programs and their differentiating product profiles, which include the expected initiation of a Phase 3 pivotal study of PL9643 in patients with dry eye disease next month, and a Phase 2 clinical trial of PL8177 for ulcerative colitis in the first half of calendar year 2022," stated Carl Spana, Ph.D., President and CEO of Palatin.

    "Regarding Vyleesi, our measured plan is showing positive trends for our targeted value metrics with net revenue up 98% and net revenue per prescription up 45% over the prior quarter ended June 30, 2021," concluded Dr. Spana.

    Recent Highlights and Upcoming Events

    • Anti-Inflammatory / Autoimmune Programs
      • PL9643 melanocortin agonist for the treatment of dry eye disease (DED):
        • Palatin remains on track to initiate its pivotal Phase 3 clinical program in DED patients in December 2021, with data readout expected in the second half of calendar year 2022.
        • Presented Phase 2 clinical trial results for PL9643 in DED at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting.
        • Presented Phase 2 clinical trial results for PL9643 in DED and preclinical data in retinal disease, at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting.
      • PL8177 melanocortin agonist for the treatment of ulcerative colitis:
        • A Phase 2 oral formulation study of PL8177 in ulcerative colitis is currently scheduled to start in the first half of calendar year 2022, with data readout expected in the second half of calendar year 2022.
      • Conducted a Featured Speaker presentation on Vyleesi and two poster presentations of PL9643 and PL8177 at the TIDES USA hybrid conference.
      • Hosted a Key Opinion Leader webinar on melanocortin agonists for treating ocular indications, with a primary focus on PL9643 and data from the Company's recently completed Phase 2 clinical trial for dry eye disease. Introduced the Company's growing portfolio of melanocortin agonists to treat the harmful effects of inflammation in the eye.
      • Presented the protective effects of PL8331 and PL9654 in mouse models of retinopathy, at the 2021 Annual Meeting of the American Society of Retina Specialists (ASRS). Awarded "Top Ten Poster" Designation.
    • Research and Development Infrastructure: Strengthened R&D department with key appointments who have demonstrated a high-level of expertise in their fields to support the advancement of our development programs.
    • Vyleesi® (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD): Goal of the Vyleesi program is to demonstrate product value in the marketplace with an objective of re-licensing the U.S. rights to a committed women's healthcare company.
      • For the quarter ended September 30, 2021:
        • Gross product sales increased 18%, net revenue increased 98%, net revenue per prescription dispensed increased 45%, despite a 13% decrease in total prescriptions dispensed, over the prior quarter ended June 30, 2021.
        • Market access, reimbursement coverage, and refill rates increased over the prior quarter ended June 30, 2021.
      • Patients and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com and www.vyleesipro.com

    First Quarter Ended Fiscal Year 2022 Financial Results

    Revenue

    Total net revenues consist of gross product sales of Vyleesi, net of allowances and accruals.

    Vyleesi gross product sales for the quarter ended September 30, 2021, amounted to $1.4 million, with net product revenue of $159,482, compared to gross product sales for the period July 25 (the date Palatin regained North American rights to Vyleesi) to September 30, 2020, of $809,100, with negative net product revenue of $(288,560).

    Operating Expenses

    Total operating expenses for the quarter ended September 30, 2021, were $7.4 million, compared to $3.7 million for the comparable quarter of 2020.

    The increase in operating expenses was primarily due to the gain of $1.6 million (which reduced expenses) recorded during the quarter ended September 30, 2020, as a result of the Vyleesi Termination Agreement with AMAG Pharmaceuticals, and secondarily to increased commercial expenses related to Vyleesi.

    Cash Flows

    Palatin's net cash used in operations for the quarter ended September 30, 2021, was $6.4 million, compared to net cash provided by operations of $3.8 million for the same period in 2020. The difference is due to the cash received in excess of the gain on termination of the Vyleesi agreement with AMAG.

    Net Loss

    Palatin's net loss for the quarter ended September 30, 2021, was $7.1 million, or $0.03 per basic and diluted common share compared to a net loss of $3.9 million or $0.02 per basic and diluted common share for the same period in 2020.

    The difference between the quarter ended September 30, 2021, and the quarter ended September 30, 2020, was primarily due to the gain of $1.6 million recorded during the quarter ended September 30, 2020, as a result of the Vyleesi Termination Agreement with AMAG Pharmaceuticals and secondarily to increased commercial expenses related to Vyleesi.

    Cash Position

    As of September 30, 2021, Palatin's cash and cash equivalents were $53.4 million with $0.9 million of accounts receivable, compared to cash and cash equivalents of $60.1 million with $1.6 million of accounts receivable, as of June 30, 2021.

    Based on its current operating plan, Palatin believes that existing cash and cash equivalents will be sufficient to fund currently anticipated operating expenses through calendar year 2022.

    Conference Call / Webcast

    Palatin will host a conference call and audio webcast on November 15, 2021, at 9:30 a.m. Eastern Time to discuss the quarter ended September 30, 2021, results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-877-614-0009 (US/Canada) or 1-856-344-9283 (international), conference ID 3594800. 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 1-888-203-1112 (US/Canada) or 1-719-457-0820 (international), passcode 3594800. The webcast and telephone replay will be available through November 22, 2021.

    About Melanocortin Receptor Agonists and Inflammation

    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 and natriuretic peptide 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.

    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 market potential of Vyleesi and other Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, market potential for product candidates, and potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, 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, Palatin's ability to establish and maintain the capability for manufacturing, marketing and distribution of Vyleesi, sales of Vyleesi in the United States and elsewhere in the world, 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 for events that occur after the date of this press release.

     

    PALATIN TECHNOLOGIES, INC.

    and Subsidiary

    Consolidated Statements of Operations

    (unaudited)













    Three Months Ended September 30,





    2021



    2020













    REVENUES









    Product revenue, net

    $                      159,482



    $                   (288,560)





    159,482



    (288,560)



    OPERATING EXPENSES









        Cost of products sold

    53,933



    25,200



    Research and development

    3,484,764



    2,923,851



    Selling, general and administrative

    3,836,542



    2,331,606



    Gain on license termination agreement

    -



    (1,623,795)



    Total operating expenses

    7,375,239



    3,656,862













    Loss from operations

    (7,215,757)



    (3,945,422)













    OTHER INCOME (EXPENSE)









    Investment income

    1,410



    12,135



    Foreign currency gain

    107,359



    -



    Interest expense

    (5,631)



    (7,489)



    Total other income, net

    103,138



    4,646













    NET LOSS

    $                 (7,112,619)



    $                (3,940,776)























    Basic and diluted net loss per common share

    $                          (0.03)



    $                         (0.02)



    Weighted average number of common shares

    outstanding used in computing basic and diluted net

    loss per common share

    238,233,063



    236,345,862













     

    PALATIN TECHNOLOGIES, INC.

    and Subsidiary

    Consolidated Balance Sheets

    (unaudited)











    September 30, 2021



    June 30, 2021

    ASSETS







    Current assets:







    Cash and cash equivalents

    $               53,421,179



    $      60,104,919

    Accounts receivable

    914,015



    1,580,443

    Inventories

    1,108,067



    1,162,000

    Prepaid expenses and other current assets

    2,946,797



    3,059,679

    Total current assets

    58,390,058



    65,907,041









    Property and equipment, net

    140,022



    94,817

    Right-of-use assets

    1,146,332



    1,237,813

    Other assets

    56,916



    56,916

    Total assets

    $               59,733,328



    $      67,296,587









    LIABILITIES AND STOCKHOLDERS' EQUITY 







    Current liabilities:







    Accounts payable 

    $                    762,817



    $           640,650

    Accrued expenses

    4,991,164



    5,797,378

    Short-term operating lease liabilities

    353,925



    351,853

    Other current liabilities

    3,679,852



    3,721,907

    Total current liabilities

    9,787,758



    10,511,788









    Long-term operating lease liabilities

    808,840



    900,520

    Other long-term liabilities

    6,167,603



    6,232,907

    Total liabilities

    16,764,201



    17,645,215









    Stockholders' equity:







    Preferred stock of $0.01 par value – authorized 10,000,000 shares; shares

    issued and outstanding designated as follows:







    Series A Convertible: authorized 264,000 shares: issued and outstanding

    4,030 shares as of September 30, 2021 and June 30, 2021

    40



    40

    Common stock of $0.01 par value – authorized 300,000,000 shares:







    issued and outstanding 231,301,673 shares as of September 30, 2021 and

    230,049,691 shares as of June 30, 2021 

    2,313,017



    2,300,497

    Additional paid-in capital

    399,564,086



    399,146,232

    Accumulated deficit 

    (358,908,016)



    (351,795,397)

    Total stockholders' equity 

    42,969,127



    49,651,372

    Total liabilities and stockholders' equity

    $               59,733,328



    $      67,296,587









     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/palatin-reports-first-quarter-fiscal-year-2022-results-and-provides-corporate-update-301423576.html

    SOURCE Palatin Technologies, Inc.

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