PTN Palatin Technologies Inc.

0.56
+0.04  (+8%)
Previous Close 0.51
Open 0.47
52 Week Low 0.33
52 Week High 1.3
Market Cap $128,998,124
Shares 231,345,273
Float 227,107,876
Enterprise Value $66,745,634
Volume 41,870,356
Av. Daily Volume 3,275,288
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Upcoming Catalysts

Drug Stage Catalyst Date
PL-8177
Ulcerative colitis
Phase 2
Phase 2
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PL9643
Dry eye disease (DED)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
PL-8177
Non-infectious uveitis
Phase 2
Phase 2
Phase 2 trial planned for 2H 2021.
PL-3994
Heart failure
Phase 2a
Phase 2a
Phase 2 dosing commenced November 2020.

Latest News

  1. 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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  2. CRANBURY, N.J., Nov. 10, 2021 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN) will announce its first quarter, fiscal year 2022 operating results on Monday, November 15, 2021, before the open of the U.S. financial markets.

    Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on November 15, 2021, at 9:30 a.m. ET. The conference call will include a review of the company's operating results and an update on programs under development.

    Schedule for the Operating Results Press Release, Conference Call / Audio Webcast

    Q1 Fiscal Year 2022 Results Press Release                  

    11/15/2021 at 7:30 a.m. ET





    Q1 Fiscal Year 2022 Conference Call-Live              

    11/15/2021 at 9:30 a.m. ET

      US/Canada Dial-In Number:                                        

    1-877-614-0009

      International Dial-In Number:                                  

    1-856-344-9283

      Conference ID: 

    3594800





    Q1 Fiscal Year 2022 Conference Call-Replay                

    11/15/2021-11/22/2021

      US/Canada Dial-In Number:                                       

    1-888-203-1112

      International Dial-In Number:                                  

    1-719-457-0820

      Replay Passcode:

    3594800





    Audio Webcast Live and Replay Access  

    http://www.palatin.com

    The audio webcast and replay can be accessed by logging on to the "Investors-Webcasts" section of Palatin's website at http://www.palatin.com.

    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.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/palatin-to-report-first-quarter-fiscal-year-2022-results-teleconference-and-webcast-to-be-held-on-november-15-2021-301421631.html

    SOURCE Palatin Technologies, Inc.

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  3. CRANBURY, N.J., Oct. 22, 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 that its pre-clinical diabetic retinopathy poster demonstrating the positive effects of melanocortin agonists for retinal inflammation was awarded a Top 10 Posters designation at the  American Society of Retina Specialists (ASRS) 2021 Annual Meeting.

    "We appreciate this acknowledgement and recognition by the medical and scientific community of the extraordinary potential of melanocortin agonists to treat inflammatory diseases," said Carl Spana, PhD, CEO and President of Palatin.  "Our research team includes experts in melanocortin drug development that consistently produce robust and comprehensive data demonstrating the potential of Palatin's melanocortin agonists in treating inflammatory conditions of the eye, gut, kidney and other indications."

    The presentation highlighting the positive pre-clinical protective effects of melanocortin 1 receptor agonists PL8331 and PL9654 in mouse models of retinopathy, and the possible utility of melanocortins in the treatment of diabetic retinopathy and choroidal neovascularization, was made at the ASRS 2021 Annual Meeting, held October 8-12, 2021.

    "We are honored to have our poster recognized by ASRS as a Top 10 poster," said John Dodd, PhD, Senior Vice President of Preclinical Research at Palatin. "It speaks to the interest and enthusiasm in the scientific community about the potential of the melanocortin mechanism to treat inflammatory conditions. We are excited to share this retina and other inflammatory disease model data where we see melanocortin agonists work so well."

    A link to the ASRS conference website and short video presentation about the poster by John Dodd, PhD, can be found here: 2021 Top 10 Poster Award Winners - The American Society of Retina Specialists (asrs.org)

    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.

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/palatin-awarded-top-10-poster-designation-at-the-american-society-of-retina-specialists-asrs-2021-annual-meeting-301406509.html

    SOURCE Palatin Technologies, Inc.

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  4. CRANBURY, N.J., Sept. 29, 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 fourth quarter and fiscal year ended June 30, 2021.

    "During the past year, we worked diligently advancing our lead investigational compound PL9643 through a successful Phase 2 clinical trial, towards a pivotal Phase 3 clinical trial for the treatment of dry eye disease, currently one of the largest markets in ophthalmology," stated Carl Spana, Ph.D., President and CEO of Palatin. "We believe that, if approved, PL9643's quick onset of efficacy, favorable tolerability, and safety profile has the potential to be a first-line therapy for the millions of individuals suffering from DED."

    Dr. Spana further commented, "Our strong cash position of $60.1 million at June 30, 2021, provides us with a sufficient operating cash runway through calendar year 2022, allowing us to advance our novel melanocortin-based programs, including top-line data readouts for our Phase 3 DED clinical trial and our PL8177 Phase 2 clinical trial for ulcerative colitis in the second half of calendar year 2022."

    Recent Highlights and Upcoming Events

    • Anti-Inflammatory / Autoimmune Programs
      • PL9643 melanocortin agonist for the treatment of dry eye disease (DED):
        • Announced the completion of its End-of-Phase 2 (EOP2) meeting with the Food and Drug Administration (FDA). The EOP2 meeting included all aspects of PL9643's development plan, with the FDA and Palatin reaching agreement on all key elements of a pivotal Phase 3 clinical program, including study design, endpoints, interim assessment, and patient population. In addition, a potential second Phase 3 study and long-term safety study were discussed to support a New Drug Application (NDA).
        • Palatin remains on track to initiate the Phase 3 program in DED patients during the fourth quarter of calendar year 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 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 the fourth quarter of calendar year 2021, with data readout expected in the second half of calendar year 2022.
      • Two featured speaker presentations 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.
      • Presenting the protective effects of PL8331 and PL9654 in mouse models of retinopathy, scheduled at the 2021 Annual Meeting of the American Society of Retina Specialists (ASRS), being held October 8-12, 2021.
    • Senior Leadership Additions – Appointed Michael B. Raizman, M.D. as Chief Medical Officer; James E. Hattersley as Senior Vice President of Business Development; and, J. Don Wang, Ph.D. as Vice President of Product Development.
    • Vyleesi® (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD). Palatin's goal with the Vyleesi program is to demonstrate value in the marketplace by increasing HCP awareness, patient engagement, and market access, with an objective of re-licensing the U.S. rights to a committed women's healthcare company.
      • For the quarter ended June 30, 2021:
        • Gross product sales increased 28%, net revenue increased 149%, and total prescriptions increased 17%, over the quarter ended December 31, 2020 (Palatin's first full quarter of Vyleesi operations).
        • Gross product sales decreased 32%, net revenue decreased 9%, and total prescriptions decreased 5%, over the prior quarter ended March 31, 2021.
        • Refill rates increased over the quarters ended December 31, 2020, and March 31, 2021.
        • Market access and reimbursement coverage increased over the quarters ended December 31, 2020, and March 31, 2021.
      • Patients and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com.

    Fourth Quarter and Fiscal Year Ended 2021 Financial Results

    Revenue

    Total net revenues consist of net product revenues of Vyleesi and license and contract revenue.

    Vyleesi gross sales for the quarter and year ended June 30, 2021, amounted to $1.2 million and $4.7 million, respectively, with net product revenue, net of allowances and accruals, of $80,504 and ($283,286), respectively. Palatin recognized no product revenues for the quarter and year ended June 30, 2020.

    Palatin recognized $94,689 in the license and contract revenue for the quarter and year ended June 30, 2021, related to our license agreement with Kwangdong, compared to $117,989 for the year ended June 30, 2020, related to our license agreement with AMAG Pharmaceuticals.

    Operating Expenses

    Total operating expenses for the quarter and year ended June 30, 2021, were $13.9 million and $33.2 million, respectively, compared to $7.4 million and $23.7 million, respectively, for the same periods of 2020. 

    The increase in operating expenses for 2021 was primarily due to the recognition of non-cash expenses on the Vyleesi license termination agreement and the increase in selling, general and administrative expenses, offset by a decrease in research and development expenses.

    Other Income/Expense, net

    Total other expense, net, for the quarter and year ended June 30, 2021, was $231,551 and $212,394, respectively, compared to total other income, net of $90,667 and $1.2 million, respectively, for the same periods in 2020. 

    The differences are related primarily to the decrease in investment income and secondarily to the recognition of foreign currency losses.

    Cash Flows

    Palatin's net cash used in operations for the quarter and year ended June 30, 2021, was $8.5 million and $22.6 million, respectively, compared to net cash used in operations of $6.1 million and net cash provided by operations of $41.3 million, respectively, for the same periods in 2020.

    Net Loss

    Palatin's net loss for the quarter and year ended June 30, 2021, was $13.9 million and $33.6 million, or $0.06 and $0.14 per basic and diluted common share, respectively, compared to a net loss of $7.3 million and $22.4 million, or $0.03 and $0.10 per basic and diluted common share, respectively, for the same periods in 2020.

    The difference between the quarter and year ended June 30, 2021, and 2020, was primarily due to an increase in selling, general and administrative expenses pursuant to Palatin's reacquisition of all development and commercialization rights to Vyleesi in North America in July 2020, and secondarily, related to the recognition of a non-cash loss on the Vyleesi license termination agreement.

    Cash Position

    As of June 30, 2021, Palatin's cash and cash equivalents were $60.1 million with $1.6 million of accounts receivable, compared to cash and cash equivalents of $82.9 million with no accounts receivable, as of June 30, 2020. Based on its current operating plan, Palatin believes that existing cash and cash equivalents will be sufficient to fund currently anticipated operating expenses through the end of calendar year 2022.

    Conference Call / Webcast

    Palatin will host a conference call and audio webcast on September 29, 2021, 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 1-800-437-2398 (US/Canada) or 1-856-344-9206 (international), conference ID 3395813. 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 approximately 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 3395813. The webcast and telephone replay will be available through October 6, 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, like 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.

    Vyleesi® is a registered trademark of Palatin.

     

    PALATIN TECHNOLOGIES, INC.

    and Subsidiary

    Consolidated Statements of Operations

    (unaudited)



















    Three Months Ended June 30,



    Year Ended June 30,



    2021



    2020



    2021



    2020

















    REVENUES















    Product revenue, net

    $          80,504



    $                -



    $      (283,286)



    $                -

    License and contract

    94,689



    -



    94,689



    117,989



    175,193



    -



    (188,597)



    117,989

















    OPERATING EXPENSES















    Cost of products sold

    37,800



    -



    147,840



    -

    Research and development

    3,481,800



    3,933,034



    12,926,559



    13,959,397

    Selling, general and administrative

    5,950,339



    3,456,805



    17,336,913



    9,765,372

    Loss on license termination agreement

    4,407,987



    -



    2,784,192



    -

    Total operating expenses

    13,877,926



    7,389,839



    33,195,504



    23,724,769

















    Loss from operations

    (13,702,733)



    (7,389,839)



    (33,384,101)



    (23,606,780)

















    OTHER (EXPENSE) INCOME















    Investment income

    3,803



    98,977



    23,572



    1,200,898

    Foreign currency loss

    (221,274)



    -



    (212,526)



    -

    Interest expense

    (14,080)



    (8,310)



    (23,440)



    (20,141)

    Total other (expense) income, net

    (231,551)



    90,667



    (212,394)



    1,180,757

















    NET LOSS

    $  (13,934,284)



    $    (7,299,172)



    $ (33,596,495)



    $  (22,426,023)

































    Basic and diluted net loss per common share

    $            (0.06)



    $            (0.03)



    $           (0.14)



    $            (0.10)

















    Weighted average number of common shares

    outstanding used in computing basic and diluted net

    loss per common share

    237,025,231



    235,394,831



    236,650,101



    234,684,776

     

    PALATIN TECHNOLOGIES, INC.

    and Subsidiary

    Consolidated Balance Sheets

    (unaudited)











    June 30, 2021



    June 30, 2020

    ASSETS







    Current assets:







    Cash and cash equivalents

    $      60,104,919



    $      82,852,270

    Accounts receivable

    1,580,443



    -

    Inventories

    1,162,000



    -

    Prepaid expenses and other current assets

    3,059,679



    738,216

    Total current assets

    65,907,041



    83,590,486









    Property and equipment, net

    94,817



    140,216

    Right-of-use assets

    1,237,813



    1,266,132

    Other assets

    56,916



    56,916

    Total assets

    $      67,296,587



    $      85,053,750









    LIABILITIES AND STOCKHOLDERS' EQUITY 







    Current liabilities:







    Accounts payable 

    $           640,650



    $           715,672

    Accrued expenses

    5,797,378



    2,899,097

    Short-term operating lease liabilities 

    351,853



    312,784

    Other current liabilities

    3,721,907



    -

    Total current liabilities

    10,511,788



    3,927,553









    Long-term operating lease liabilities 

    900,520



    953,348

    Other long-term liabilities

    6,232,907



    -

    Total liabilities

    17,645,215



    4,880,901

















    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 June 30, 2021 and June 30, 2020

    40



    40

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







    issued and outstanding 230,049,691 shares as of June 30, 2021 and

    229,258,400 shares as of June 30, 2020 

    2,300,497



    2,292,584

    Additional paid-in capital

    399,146,232



    396,079,127

    Accumulated deficit 

    (351,795,397)



    (318,198,902)

    Total stockholders' equity 

    49,651,372



    80,172,849

    Total liabilities and stockholders' equity

    $      67,296,587



    $      85,053,750

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/palatin-reports-fourth-quarter-and-full-year-fiscal-year-2021-financial-results-and-provides-corporate-update-301387386.html

    SOURCE Palatin Technologies, Inc.

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  5. CRANBURY, N.J., Sept. 27, 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 presentation of the protective effects of melanocortin 1 receptor agonists PL8331 and PL9654 in mouse models of retinopathy, at the 2021 Annual Meeting of the American Society of Retina Specialists (ASRS), being held virtually October 8-12, 2021.

    The presentation highlights the positive pre-clinical data in mouse models of retinopathy, and the possible utility of melanocortin receptor agonists in the treatment of diabetic retinopathy and choroidal neovascularization.

    "The research and development team at Palatin continues to produce positive data in inflammatory disease models, including front of the eye, the gastrointestinal system, and now back of the eye," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin.  "Our preclinical and clinical research continues to build support for the melanocortin system as a target for treating a wide range of inflammatory diseases. The preclinical retina inflammation data is exciting and provides support for moving compounds in our robust melanocortin agonist platform towards human clinical studies." 

    Presentation details

    Date:   

    October 9, 2021

    Time:  

    5:35 pm to 6:35 pm Central Time

    Format: 

    Poster Presentation

    Presenter: 

    John Dodd, Ph.D., Palatin Preclinical Development

    Title: 

    "Protective Effects of Two Melanocortin Agonists Delivered by Intravitreal

    Injection in Mouse Models of Retinopathy"

    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, like 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, 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.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/palatin-announces-presentation-of-positive-protective-effects-of-pl8331-and-pl9654-on-retinal-inflammation-at-the-2021-american-society-of-retina-specialists-asrs-annual-meeting-301385088.html

    SOURCE Palatin Technologies, Inc.

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