PTN Palatin Technologies Inc.

0.57
-0.02  -3%
Previous Close 0.59
Open 0.59
52 Week Low 0.355
52 Week High 1.133
Market Cap $131,250,434
Shares 229,258,400
Float 226,437,250
Enterprise Value $43,243,065
Volume 1,026,142
Av. Daily Volume 3,091,924
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Upcoming Catalysts

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

Drug Stage Notes
PL8177
COVID-19
Phase 2
Phase 2
Phase 2 trial to be initiated 4Q 2020.
PL-3994
Heart failure
Phase 2a
Phase 2a
Phase 2 trial to commence 2H 2020.
PL-8177
Non-infectious uveitis
Phase 2
Phase 2
Phase 2 trial to commence 2H 2021.
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
Approved
Approved
FDA approval announced June 21, 2019.

Latest News

  1. CRANBURY, N.J., July 27, 2020 /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 and natriuretic peptide receptor systems, today announced that it has mutually terminated the January 2017 license agreement which granted AMAG Pharmaceuticals ("AMAG") exclusive North American rights to market Vyleesi® (bremelanotide), the first and only on demand treatment for pre-menopausal women suffering from acquired, generalized, hypoactive sexual desire disorder (HSDD), a condition affecting one in ten premenopausal women.

    CRANBURY, N.J., July 27, 2020 /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 and natriuretic peptide receptor systems, today announced that it has mutually terminated the January 2017 license agreement which granted AMAG Pharmaceuticals ("AMAG") exclusive North American rights to market Vyleesi® (bremelanotide), the first and only on demand treatment for pre-menopausal women suffering from acquired, generalized, hypoactive sexual desire disorder (HSDD), a condition affecting one in ten premenopausal women.

    Under the terms of the termination agreement, Palatin will regain all North American development and commercialization rights for Vyleesi. AMAG will make a $12 million payment to Palatin at closing and a $4.3 million payment to Palatin on March 31, 2021. Palatin will assume all Vyleesi manufacturing agreements, and AMAG will transfer all information, data, and assets related exclusively to Vyleesi, including, but not limited to, existing inventory. AMAG will provide certain transitional services to Palatin for a period of time to ensure continued patient access to Vyleesi during the transition back to Palatin. Palatin will reimburse AMAG for the costs of the transition services.

    "We continue to believe that Vyleesi is an important treatment option for the millions of premenopausal women suffering from HSDD and are pleased that our termination and transfer agreement with AMAG ensures no disruption for patient access to Vyleesi," stated Carl Spana, Ph.D., President and CEO of Palatin. "Having full ownership of an FDA approved product provides us with the ability to capitalize on a broad range of strategic opportunities, including the re-licensing of Vyleesi to a partner that is committed to women's health."

    "As a clinician who treats women who suffer from HSDD, a medical condition which extends well beyond the bedroom and that can significantly impact self-esteem, body image, and intimate relationships, I am pleased that Palatin is dedicated to the continued affordable access and commercialization of Vyleesi, a treatment option that can be delivered on an as-needed basis," said Sheryl Kingsberg, Ph.D., Division Chief of Behavioral Medicine, University Hospitals Cleveland Medical Center." 

    Palatin is exploring strategic options with the goal of enhancing the commercialization of Vyleesi, including but not limited to, discussions with companies that currently market female healthcare products for potential collaborations. In the interim, the Company's go forward strategy is to implement an informed and highly targeted approach for marketing, utilizing telemedicine, social media, and digital advertising. The Company is committed to working with payers and healthcare professionals to ensure women with HSDD have continued and affordable access to Vyleesi. Vyleesi remains commercially available through specialty pharmacies, Avella and BioPlus, with patients also having the ability to connect with a physician through a telemedicine option. Patients and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com.

    Vyleesi is the first FDA-approved product for the as-needed treatment of premenopausal women who experience distress or interpersonal difficulty due to low sexual desire. This treatment is available as a subcutaneous self-injection in a prefilled disposable autoinjector pen for use in anticipation of a sexual encounter.

    Conference Call / Webcast

    Palatin will host a conference call and audio webcast on July 27, 2020 at 8:30 a.m. Eastern Time to discuss its Vyleesi program in greater detail.  Individuals interested in listening to the conference call live can dial 1-800-700-1722 (US/Canada) or 1-334-323-0509 (international), conference ID 9136500.  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 9136500  The webcast and telephone replay will be available through August 3, 2020.

    About Vyleesi® (bremelanotide injection)

    Vyleesi is approved for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The prefilled Vyleesi autoinjector pen is self-administered into a woman's abdomen or thigh at least 45 minutes before anticipated sexual activity and can be taken at any time of day. Vyleesi is thought to possess a novel mechanism of action. While the exact mechanism of action is unknown, Vyleesi is believed to bind to melanocortin receptors in the central nervous system that are thought to be associated with sexual function.

    The most common adverse events were nausea, flushing, injection site reactions and headache. The majority of events were reported to be transient and mild-to-moderate in intensity.

    About Hypoactive Sexual Desire Disorder (HSDD)

    HSDD is the most common type of female sexual dysfunction in the U.S. The condition is characterized by low sexual desire and marked distress which are not attributable to existing medical, pharmacologic, psychiatric, or relationship issues.i Approximately 6 million pre-menopausal women meet the diagnosis criteria for acquired, generalized HSDD.ii Patient awareness and understanding of the condition remains low, and few women currently seek or receive treatment. Industry-sponsored market research indicates that up to 95 percent of premenopausal women suffering from HSDD are unaware that it is a treatable medical condition.iii 

    About Palatin Technologies, Inc.

    Palatin Technologies, Inc. is a specialized 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 in order 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 commercial strategies and efforts, including regaining all North American development and commercialization rights for Vyleesi, estimates and beliefs regarding the market opportunities for Vyleesi, transitional services for Vyleesi to be provided by AMAG, 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 market and commercialize Vyleesi in the United States, 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.

    i Shifren et al, Sexual Problems and Distress in United States Women; Obstetrics & Gynecology, Vol. 112, No. 5, November 2008; 2014 U.S. Census data

    ii Patient & Economic Flow Study sponsored by Palatin Technologies, Inc. and conducted by Burke Institute, April 2016

    iii Patient & Economic Flow Study sponsored by Palatin Technologies, Inc. and conducted by Burke Institute, April 2016

     

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    SOURCE Palatin Technologies, Inc.

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  2. CRANBURY, N.J., July 8, 2020 /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 and natriuretic peptide receptor systems, today announced reinitiation of enrollment of its Phase 2 study with PL9643 for the treatment of dry eye disease (DED).

    Palatin_Technologies_Logo

     

    After pausing patient recruitment to ensure patient safety during the initial phases of the COVID-19 pandemic, Palatin has commenced patient recruitment in its PL9643 Phase 2 clinical study in subjects with dry eye disease.  Patient enrollment is currently expected to be complete within the next 30-45 days, with data readout targeted for the fourth quarter of…

    CRANBURY, N.J., July 8, 2020 /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 and natriuretic peptide receptor systems, today announced reinitiation of enrollment of its Phase 2 study with PL9643 for the treatment of dry eye disease (DED).

    Palatin_Technologies_Logo

     

    After pausing patient recruitment to ensure patient safety during the initial phases of the COVID-19 pandemic, Palatin has commenced patient recruitment in its PL9643 Phase 2 clinical study in subjects with dry eye disease.  Patient enrollment is currently expected to be complete within the next 30-45 days, with data readout targeted for the fourth quarter of calendar year 2020.

    "We are very happy to resume patient recruitment in this Phase 2 study of PL9643 exploring treatment of both the signs of eye damage and the physical symptoms experienced by patients with dry eye disease," commented Carl Spana, Ph.D., President and CEO of Palatin.

    This Phase 2 study is a multi-center, randomized double-masked, placebo-controlled study evaluating the safety and efficacy of PL9643 ophthalmic solution (topical eye drops) compared to placebo for the treatment of the signs and symptoms of dry eye disease. The study is designed to enroll up to 150 participants at three sites in the US. Patients will be randomized in a 1:1 ratio into two arms, PL9643 or placebo, and will undergo 12-weeks of treatment. For more information about the study, including inclusion/exclusion criteria, a clinical trial synopsis can be found on clinicaltrials.gov 

    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 30 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 weeks or months to demonstrate activity.

    About Palatin Technologies, Inc.

    Palatin Technologies, Inc. is a specialized 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 in order 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 clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, AMAG's plans to divest Vyleesi, Palatin's ongoing relationship with AMAG and ability to protect its rights as the Vyleesi licensor, 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, transfer of marketing and sale of Vyleesi in North America to another pharmaceutical company, 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.

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    SOURCE Palatin Technologies, Inc.

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  3. CRANBURY, N.J., June 29, 2020 /PRNewswire/ -- Palatin Technologies, Inc. ("Palatin") (NYSE:PTN) announced that its 2020 Annual Meeting of Stockholders that convened on June 25, 2020 has been adjourned until July 23, 2020 at 9:00 a.m. Eastern Daylight Time to solicit additional proxies for Proposal 4, approval of an amendment to our Certificate of Incorporation to effect an increase in authorized common stock from 300,000,000 shares to 500,000,000 shares. The adjourned meeting will be a completely "virtual" meeting of stockholders, and stockholders will be able to listen and participate in the virtual annual meeting as well as vote and submit your questions during the live webcast of the meeting by visiting http://www.virtualshareholdermeeting.com/PTN2020

    CRANBURY, N.J., June 29, 2020 /PRNewswire/ -- Palatin Technologies, Inc. ("Palatin") (NYSE:PTN) announced that its 2020 Annual Meeting of Stockholders that convened on June 25, 2020 has been adjourned until July 23, 2020 at 9:00 a.m. Eastern Daylight Time to solicit additional proxies for Proposal 4, approval of an amendment to our Certificate of Incorporation to effect an increase in authorized common stock from 300,000,000 shares to 500,000,000 shares. The adjourned meeting will be a completely "virtual" meeting of stockholders, and stockholders will be able to listen and participate in the virtual annual meeting as well as vote and submit your questions during the live webcast of the meeting by visiting http://www.virtualshareholdermeeting.com/PTN2020 and entering the 16–digit control number included in your Notice Regarding the Availability of Proxy Materials, on your proxy card or in the instructions that accompanied your proxy materials.

    The Board of Directors believes approval of Proposal 4 is in the best interests of Palatin and its stockholders because even though Palatin has sufficient operating cash for at least two years and does not have any current plans to offer any additional stock in the foreseeable future, an increase provides future flexibility and the necessary resources Palatin requires to take advantage of any strategic opportunities that could result in an increase in stockholder value.  Proposal 4 is described in more detail in Palatin's proxy statement dated May 11, 2020, furnished to stockholders in connection with the 2020 Annual Meeting.

    We have seen significant stockholder support for Proposal 4.  At the time of the meeting, approximately 58% of the shares that had been voted on Proposal 4 were voted in its favor.  However, the favorable votes were less than the absolute majority of all outstanding shares, which is required for approval of this proposal.  Proposals 1, 2, 3 and 5 were approved at the Annual Meeting.

    Palatin encourages any stockholder that has not yet voted its shares on Proposal 4 or is uncertain if their shares have been voted on Proposal 4 to contact their broker or bank. The Board of Directors and management respectfully requests stockholders as of the record date, April 29, 2020, to please vote their proxies as soon as possible, but no later than July 22, 2020 at 11:59 p.m. (Eastern Time). Stockholders who have previously submitted their proxy or otherwise voted for the annual meeting and who do not want to change their vote need not take any action. For questions relating to the voting of shares or to request additional or misplaced proxy voting materials, please contact Palatin's proxy advisory group at .

    As described in the proxy statement, a stockholder may use one of the following simple methods to vote before the July 23, 2020 adjourned meeting with respect to Proposal 4:

    • By Internet – www.proxyvote.com. If you have Internet access, you may transmit your voting instructions up until 11:59 p.m., Eastern Daylight Time, the day before the adjourned meeting date, that is, July 22, 2020. Go to www.proxyvote.com. You must have your proxy card or Notice in hand when you access the web site and follow the instructions to obtain your records and to create an electronic voting instruction form.
    • By telephone – 1-800-690-6903. You may vote using any touch-tone telephone to transmit your voting instructions up until 11:59 p.m., Eastern Daylight Time, the day before the meeting date, that is, July 22, 2020. Call 1-800-690-6903 toll free. You must have your proxy card or Notice in hand when you call this number and then follow the instructions.
    • By mail – Mark, sign and date your proxy card and return it in the postage-paid envelope we have provided. If you did not receive a proxy copy, you may request proxy materials, including a proxy card, by following the instructions in the Notice.

    Votes must be received by 11:59 P.M. Eastern Daylight Time on July 22, 2020 to be counted. After this time, the only way to cast a vote is at the adjourned Annual Meeting on July 23, 2020, 9:00 a.m. Eastern Daylight Time at http://www.virtualshareholdermeeting.com/PTN2020.

    About Palatin Technologies, Inc.

    Palatin Technologies, Inc. is a specialized 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 in order 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 the need to for stockholders to approve Proposal 4, 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, 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.

    Important Information

    In connection with the solicitation of proxies, on May 11, 2020, Palatin filed a definitive proxy statement with the Securities and Exchange Commission ("SEC") in connection with Palatin's 2020 Annual Meeting. STOCKHOLDERS ARE STRONGLY ADVISED TO READ THE DEFINITIVE PROXY MATERIALS AND ANY OTHER RELEVANT SOLICITATION MATERIALS FILED BY PALATIN TECHNOLOGIES, INC. WITH THE SEC BEFORE MAKING ANY VOTING OR INVESTMENT DECISION BECAUSE THESE DOCUMENTS CONTAIN IMPORTANT INFORMATION. Palatin's proxy statement and any other materials filed by Palatin with the SEC can be obtained free of charge at the SEC's web site at www.sec.gov. Palatin's proxy statement, notice of annual meeting, and annual report to shareholders are available free of charge on Palatin's website at www.palatin.com. The contents of the websites referenced above are not deemed to be incorporated by reference into the proxy statement.

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    SOURCE Palatin Technologies, Inc.

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  4. CRANBURY, N.J., June 23, 2020 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, today announced it is developing PL8177 as a treatment for patients with COVID-19, the disease caused by infection with the SARS-CoV-2 virus, and having hypoxemic respiratory failure with or without acute respiratory distress syndrome (ARDS). This decision was based on positive results in preclinical multiple inflammatory disease models and a lung injury model, which showed the ability of PL8177 to reduce inflammation, protect lung tissue and reduce lung fibrosis.

    CRANBURY, N.J., June 23, 2020 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, today announced it is developing PL8177 as a treatment for patients with COVID-19, the disease caused by infection with the SARS-CoV-2 virus, and having hypoxemic respiratory failure with or without acute respiratory distress syndrome (ARDS). This decision was based on positive results in preclinical multiple inflammatory disease models and a lung injury model, which showed the ability of PL8177 to reduce inflammation, protect lung tissue and reduce lung fibrosis.

    Palatin submitted a preliminary proposal to the Biomedical Advanced Research and Development Authority (BARDA) on this program, received technical and strategic advice, and submitted a pre-Investigational New Drug (pre-IND) package to the Division of Pulmonary, Allergy, and Critical Care (DPACC) of the U.S. Food and Drug Administration (FDA). Based on advice from DPACC the Company is planning to submit an IND in the third quarter of calendar year 2020 and planning a Phase 2 clinical trial initiation in the fourth quarter of calendar year 2020. Required preclinical and Phase 1 safety studies are complete and support the safe use of PL8177 in a Phase 2 clinical study. In addition, Palatin is pursuing multiple sources for research and development grants to support PL8177 clinical development.

    "We are excited about PL8177's potential to be part of the solution to this unprecedented global public health crisis," said Carl Spana Ph.D., President and CEO of Palatin. "What is differentiating about PL8177 is its potential to reduce the inflammation associated with progressive COVID-19 disease and to reduce lung fibrosis, which can compromise patient lung function after recovering from the viral infection."

    Dr. Spana further commented, "The adaptive design of the Phase 2 clinical study will provide early and multiple looks at the results, allowing us to assess the effectiveness of PL8177 and possible study modifications for patient benefit."

    PL8177, a potent and selective melanocortin 1 receptor (MC1r) agonist, has demonstrated efficacy in multiple preclinical models of inflammatory disease and reduced lung tissue damage and fibrosis in a preclinical model of lung fibrosis.

    The primary objective of the phase 2 randomized controlled study will be to determine if the proportion of patients with moderate or severe illness that improve on the World Health Organization scale is significantly greater in the active arm compared to the placebo arm. PL8177 will be delivered as a sterile subcutaneous injection. The study will randomize patients (1:1) to a placebo plus standard of care control group or PL8177 plus standard of care treatment group. The study population will be hospitalized adult COVID-19 subjects with hypoxemic respiratory failure, with or without mild ARDS. The study will use an adaptive design with an independent Data Monitoring Committee examining the results when 25%, 50%, 75%, and 100% of the maximum sample size (176 patients, 88 per arm) has been enrolled and either completed the study or withdrawn prematurely.

    About Palatin Technologies, Inc.

    Palatin Technologies, Inc. is a specialized 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 in order 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 potential utility of candidate products in treatment of COVID-19, 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 are 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, 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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    SOURCE Palatin Technologies, Inc.

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  5. CRANBURY, N.J., May 12, 2020 /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 and natriuretic peptide receptor systems, today announced results for its third quarter ended March 31, 2020.

    Third Quarter Fiscal Year 2020 Financial Highlights

    • Net loss of $(5.4) million, compared to $(5.7) million for the comparable quarter of 2019;
    • Operating expenses of $5.7 million, compared to $5.8 million for the comparable quarter of 2019;
    • Other income was $331,007, compared to $35,648 for the comparable quarter of 2019; and
    • As of March 31, 2020, the Company had $88.9 million in cash and cash equivalents, compared to $91.5 million as of December 31, 2019, and no debt.

    Recent Business Highlights and Updates

    • Implemented multiple measures in response to the COVID-19 pandemic to safeguard the health and well-being of employees, their families, business partners and healthcare providers, while continuing to advance the Company's programs;
    • A Phase 2 clinical study with PL9643 for dry eye disease started in January 2020. Data readout is targeted for the fourth quarter of calendar year 2020;
    • A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is delayed due to the pandemic and is now targeted to start in the first half of calendar year 2021; and
    • AMAG has stated that they anticipate finalizing the divestiture of Vyleesi within the next several months.

    "The entire Palatin team thanks healthcare workers across the nation for their selfless efforts in the treatment and care of COVID-19 patients, and I would also like to thank all of our employees for their dedication and commitment to ensure the advancement of our development programs and clinical trial patient support," said Carl Spana Ph.D., President and CEO of Palatin. "Although Palatin has experienced limited adverse impact on operations from the pandemic, we are cognizant there may be further disruptions to business activity based on a resurgence of the virus and have taken steps to be as prepared as possible for this potential outcome."

    Dr. Spana further commented, "We continue to review AMAG's process related to the divestiture of Vyleesi and their obligations under our license agreement and are prepared to take appropriate steps to protect our rights and Vyleesi's significant value."

    Programs Overview

    Anti-Inflammatory / Autoimmune Programs

    A Phase 2 clinical study with PL9643 for dry eye disease started in January 2020, and active patients continue treatment and monthly clinic visits. Enrollment of additional cohorts has been delayed, but we anticipate restarting enrollment in June 2020. Data readout is targeted for the fourth quarter of calendar year 2020.

    A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is now targeted to start in the first half of calendar year 2021, with data readout in the first half of calendar year 2022.

    The Company continues its assessment and development work related to the treatment of patients with diabetic retinopathy, with an IND targeted for mid-calendar year 2021. 

    The Company currently anticipates filing an IND and commencing clinical trials with PL8177 for non-infectious uveitis, for which FDA granted orphan drug designation, in the second half of calendar year 2021.

    Hypoactive Sexual Desire Disorder ("HSDD") / Vyleesi® (bremelanotide injection)

    Due to the early commercial stage of Vyleesi and the sales and marketing strategy of our North American licensee AMAG Pharmaceuticals, Inc., including no charge for the first Vyleesi prescription, AMAG has not generated positive net sales through March 31, 2020. This has resulted in no royalties to Palatin during this period.

    Vyleesi is the first as-needed treatment approved for premenopausal women with acquired, generalized HSDD. AMAG launched Vyleesi nationally in September 2019 through select specialty pharmacies with its established women's health sales force.

    In January 2020 AMAG announced that, as a result of a strategic review, it will divest Vyleesi, which it exclusively licensed from Palatin for North America. In May 2020 AMAG stated that it is in negotiations regarding the divestiture of Vyleesi and will provide an update within the next few months.

    Palatin continues to closely monitor AMAG's process related to the divestiture of Vyleesi and AMAG's obligations under the Vyleesi license agreement. Though sales of Vyleesi have been adversely affected by the COVID-19 pandemic, the Company believes that AMAG's divestiture process has also adversely impacted Vyleesi sales. Palatin is prepared to take appropriate steps to protect its rights as the Vyleesi licensor and the significant value of the Vyleesi program.

    Palatin continues discussions on Vyleesi collaborations for territories outside the currently licensed territories of North America, China, and Korea, and anticipates executing multiple agreements during the second half of calendar year 2020 and calendar year 2021.

    Natriuretic Peptide Receptor ("NPR") System Program

    PL3994, an NPR-A agonist, will be evaluated in a Phase 2a clinical study in heart failure patients with preserved ejection fraction. The proposed study is a collaboration with two major academic medical centers and is supported by an American Heart Association grant. The study is now anticipated to start patient enrollment in the second half of calendar year 2020.

    Genetic Obesity Program

    Palatin's melanocortin receptor 4 (MC4r) peptide PL8905 and orally active small molecule PL9610 are currently under investigation for the treatment of rare genetic metabolic and obesity disorders. These programs are under internal evaluation for orphan designations, potential development, and licensing.

    Third Quarter Fiscal Year 2020 Financial Results

    Revenue

    For the quarters ended March 31, 2020 and 2019, there were no revenues recorded.

    Operating Expenses

    Total operating expenses for the quarter ended March 31, 2020 were $5.7 million compared to $5.8 million for the comparable quarter of 2019.  The decrease in operating expenses was mainly due to the overall reduction in research and development expenses offset by an increase in general and administrative expenses.

    Other Income/Expense, net

    Total other income, net, was $331,007 for the quarter ended March 31, 2020, compared to total other income, net, of $35,648 for the quarter ended March 31, 2019.  The difference is related primarily to the increase in investment income.

    Net Loss

    Palatin reported a net loss of $(5.4) million, or $(0.02) per basic and diluted share, for the quarter ended March 31, 2020, compared to a net loss of $(5.7) million, or $(0.03) per basic and diluted share, for the same period in 2019.    

    The difference in financial results between the three months ended March 31, 2020 and 2019 was mainly attributable to the increase in other income, net.

    Cash Position

    Palatin's cash and cash equivalents were $88.9 million as of March 31, 2020, compared to $91.5 million at December 31, 2019, and cash, cash equivalents and accounts receivable of $103.8 million at June 30, 2019. 

    Management believes that existing capital resources will be adequate to fund the Company's planned operations through at least March 31, 2022.

    Conference Call / Webcast

    Palatin will host a conference call and audio webcast on May 12, 2020 at 11:00 a.m. Eastern Time to discuss the results of operations for the quarter ended March 31, 2020 in greater detail and provide an update on corporate developments.  Individuals interested in listening to the conference call live can dial 1-888-204-4368 (US/Canada) or 1-323-994-2082 (international), conference ID 8845359.  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 8845359.  The webcast and telephone replay will be available through May 19, 2020.

    About Palatin Technologies, Inc.

    Palatin Technologies, Inc. is a specialized 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 in order 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 clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, AMAG's plans to divest Vyleesi, Palatin's ongoing relationship with AMAG and ability to protect its rights as the Vyleesi licensor, 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 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, transfer of marketing and sale of Vyleesi in North America to another pharmaceutical company, 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 AMAG Pharmaceuticals, Inc. in North America and of Palatin Technologies, Inc. elsewhere in the world.

    (Financial Statement Data Follows)

     

    PALATIN TECHNOLOGIES, INC.

    and Subsidiary

    Consolidated Statements of Operations

    (unaudited)










    Three Months Ended March 31,


    Nine Months Ended March 31,


    2020


    2019


    2020


    2019









    REVENUES








    License and contract

    $                 -


    $                 -


    $       117,989


    $          34,505









    OPERATING EXPENSES








    Research and development

    3,641,250


    3,943,982


    10,026,363


    10,528,329

    General and administrative

    2,072,032


    1,818,796


    6,308,567


    5,947,943

    Total operating expenses

    5,713,282


    5,762,778


    16,334,930


    16,476,272









    Loss from operations

    (5,713,282)


    (5,762,778)


    (16,216,941)


    (16,441,767)









    OTHER INCOME (EXPENSE)








    Investment income

    331,285


    107,460


    1,101,921


    361,212

    Interest expense

    (278)


    (71,812)


    (11,831)


    (370,981)

    Total other income (expense), net

    331,007


    35,648


    1,090,090


    (9,769)









    NET LOSS

    $   (5,382,275)


    $   (5,727,130)


    $ (15,126,851)


    $ (16,451,536)









    Basic and diluted  net loss per common share

    $            (0.02)


    $            (0.03)


    $            (0.06)


    $            (0.08)









    Weighted average number of common shares outstanding used in computing basic and diluted net loss  per common share

    235,322,087


    207,016,304


    234,449,813


    206,148,695

     

    PALATIN TECHNOLOGIES, INC.

    and Subsidiary

    Consolidated Balance Sheets

    (unaudited)






    March 31, 2020


    June 30, 2019

    ASSETS




    Current assets:




    Cash and cash equivalents

    $              88,947,368


    $      43,510,422

    Accounts receivable

    -


    60,265,970

    Prepaid expenses and other current assets

    675,443


    637,289

    Total current assets

    89,622,811


    104,413,681





    Property and equipment, net

    153,660


    141,539

    Right-of-use assets

    98,491


    -

    Other assets

    179,916


    179,916

    Total assets

    $              90,054,878


    $    104,735,136





    LIABILITIES AND STOCKHOLDERS' EQUITY 




    Current liabilities:




    Accounts payable 

    $                1,612,164


    $           504,787

    Accrued expenses

    1,657,237


    2,848,692

    Notes payable, net of discount

    -


    332,896

    Other current liabilities

    89,429


    499,517

    Total current liabilities

    3,358,830


    4,185,892





    Other liabilities

    9,062


    -

    Total liabilities

    3,367,892


    4,185,892





    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 March 31, 2020 and June 30, 2019

    40


    40

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




    issued and outstanding 229,240,596 shares as of March 31, 2020 and 226,815,363 shares as of June 30, 2019 

    2,292,406


    2,268,154

    Additional paid-in capital

    395,294,270


    394,053,929

    Accumulated deficit 

    (310,899,730)


    (295,772,879)

    Total stockholders' equity 

    86,686,986


    100,549,244

    Total liabilities and stockholders' equity

    $              90,054,878


    $    104,735,136





     

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