PTN Palatin Technologies Inc.

1.15
+0.14  (+14%)
Previous Close 1.01
Open 1.18
52 Week Low 0.355
52 Week High 1.09
Market Cap $264,386,503
Shares 229,901,307
Float 226,664,583
Enterprise Value $121,517,811
Volume 22,593,743
Av. Daily Volume 4,718,422
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Upcoming Catalysts

Drug Stage Catalyst Date
PL-8177
Ulcerative colitis
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
PL9643
Dry eye disease (DED)
Phase 2
Phase 2
Phase 2 trial met the primary endpoints in the moderate to severe patient population but not in the overall population including mild patients - December 15, 2020.
PL-8177
Non-infectious uveitis
Phase 2
Phase 2
Phase 2 IND filing due 2H 2021.
PL-3994
Heart failure
Phase 2a
Phase 2a
Phase 2 dosing commenced November 2020.
PL8177
COVID-19
Phase 2
Phase 2
Phase 2 trial to be initiated 1Q 2021.
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
Approved
Approved
FDA approval announced June 21, 2019.

Latest News

  1. CRANBURY, N.J., Dec. 15, 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 peptide receptor systems, today announced positive results in its Phase 2 study of PL9643 for the treatment of dry eye disease (DED). Statistically significant improvement in multiple signs and symptoms was achieved in the moderate to severe patient population after 2 weeks of dosing and at the 12-week visit. There were no safety signals identified and PL9643 had excellent ocular tolerability. However, statistical significance for the primary endpoints was not reached in the overall enrolled population that included mild…

    CRANBURY, N.J., Dec. 15, 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 peptide receptor systems, today announced positive results in its Phase 2 study of PL9643 for the treatment of dry eye disease (DED). Statistically significant improvement in multiple signs and symptoms was achieved in the moderate to severe patient population after 2 weeks of dosing and at the 12-week visit. There were no safety signals identified and PL9643 had excellent ocular tolerability. However, statistical significance for the primary endpoints was not reached in the overall enrolled population that included mild, moderate, and severe patients, as measured at the 12-week primary evaluation visit.

    "This was our first study evaluating a melanocortin agonist in an ocular disease and we are pleased that the key goals of this study were met, which was providing significant clinical evidence of efficacy, safety, and tolerability in a meaningful patient population - patients suffering from moderate to severe DED," stated Carl Spana, Ph.D., President and CEO of Palatin. "Importantly, we have a clear development and regulatory path forward. With approximately 20 million adults in the United States currently suffering from DED, the majority being moderate to severe patients, and up to 50% discontinuing treatment due to slow onset, lack of efficacy or intolerance, PL9643's potentially quick onset of efficacy and excellent tolerability profile are differentiating factors to current approved therapies."  

    In the sub-population of moderate to severe patients (N=61), PL9643 achieved statistical significance (P value <0.05 vs. vehicle) at week 2 and week 12 for multiple signs, including inferior (the primary sign endpoint), superior, and total corneal staining, temporal, nasal and total conjunctival staining, tear film break-up time, and multiple ocular symptoms, including ocular discomfort. Additionally, multiple sign and symptom measures trended towards significance (P value <0.1 vs. vehicle). Based on these positive trial results, Palatin plans to initiate a Phase 2/3 trial in the United States in mid calendar year 2021.

    "This work, utilizing the melanocortin pathway, is an excitingly novel departure from all other dry eye therapeutic strategies," said Kenneth Kenyon, M.D., Principal Investigator for the study, cornea specialist at New England Eye Center and Professor of Ophthalmology, Tufts University School of Medicine. "The demonstrated consistency of improved outcomes across multiple sign and symptom time points is most impressive. Significant improvement in both corneal and conjunctival staining is highly relevant, as it affects both vision and irritative symptoms, especially so in these more advanced dry eye patients. The emerging profile of PL9643, with its rapid therapeutic onset and excellent tolerability profile, is a potentially distinct advance in dry eye therapy."

    "The Phase 2 study of PL9643 has provided guidance on the clinical and regulatory pathway forward for this program.  The results identify the most appropriate patient population, endpoints, and timepoints for the next study.  We look forward to working with Palatin to confirm the therapeutic potential of PL9643 in treating the signs and symptoms of dry eye" said George Ousler, Senior Vice President, Anterior Segment at Ora, Inc. 

    This Phase 2 study was a multi-center, randomized, double-masked and vehicle-controlled study evaluating the efficacy and safety of PL9643 ophthalmic solution (topical eye drops) compared to vehicle for the treatment of the signs and symptoms of dry eye. The study enrolled 160 participants randomized in a 1:1 ratio into two arms, PL9643 or vehicle, at four sites in the United States. Patients underwent 12 weeks of daily treatment. The intent to treat (ITT) population included all patients with mild-moderate-severe DED. The two prespecified primary endpoints were improvement in inferior corneal staining (sign) and ocular discomfort (symptom) as measured at the 12-week primary evaluation visit. There were multiple secondary sign and symptom outcome measures as well.

    Trial results demonstrated an excellent safety and tolerability profile. There were no serious adverse events associated with study treatment observed. Three patients on placebo and one patient on PL9643 (not deemed to be drug related) discontinued from the study. Importantly, there were no ocular, drug-related adverse events in the PL9643 subjects.

    Detailed study results are anticipated to be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting.

    Conference Call / Webcast

    Palatin will host a conference call and audio webcast on December 15, 2020 at 8:00 a.m. Eastern Time to discuss its Phase 2 study of PL9643 in greater detail.  Individuals interested in listening to the conference call live can dial 1-800-367-2403 (US/Canada) or 1-334-777-6978 (international), conference ID 2038353. 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 2038353. The webcast and telephone replay will be available through December 22, 2020.

    About Dry Eye Disease (DED)

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



    About Ora, Inc.

    Ora is the world's leading full-service ophthalmic CRO and product development firm with offices in the United States, the United Kingdom and Japan. Over the past 40 years, Ora has helped clients earn 45 product approvals. Ora supports a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora's pre-clinical and clinical models, unique methodologies and regulatory strategies have been refined and proven across thousands of projects. For more information about Ora, please go to www.oraclinical.com.

    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 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, 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, 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:http://www.prnewswire.com/news-releases/palatin-technologies-announces-positive-results-from-its-phase-2-study-of-pl9643-in-patients-with-dry-eye-disease-301192765.html

    SOURCE Palatin Technologies, Inc.

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  2. CRANBURY, N.J., Nov. 17, 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 first quarter ended September 30, 2020.

    First Quarter Ended September 30, 2020 Financial Highlights

    • Net loss for the quarter was $(3.9) million, or $(0.02) per share, compared to a net loss of $(4.5) million, or $(0.02) per share for the comparable quarter of 2019;
    • Vyleesi® gross sales for the period July 25 to September 30 amounted to $809,100. Recognized $(288,560) in Vyleesi product revenue, net of allowances and accruals;
    • Recognized no contract and license revenue for the quarter, compared to $97,379 for the comparable quarter of 2019;
    • Total operating expenses for the quarter were $3.7 million, including a $1.6 million gain on the license termination agreement, compared to $5.0 million for the comparable quarter of 2019;
    • As of September 30, 2020, the Company had $86.6 million in cash and cash equivalents and $5.0 million in accounts receivable, compared to $82.9 million in cash and cash equivalents and no accounts receivable as of June 30, 2020, with no outstanding debt.

    Business Highlights and Updates

    • In July 2020, regained exclusive North American rights to market Vyleesi® (bremelanotide injection), the first and only on demand treatment for premenopausal women suffering from acquired, generalized, hypoactive sexual desire disorder (HSDD), a condition affecting one in ten premenopausal women;
    • Vyleesi commercial activities: solidified the distribution network and procedures, improved contact with prescribers and healthcare providers through virtual meetings, increased insurance reimbursement coverage, and initiated a highly-selective  digital marketing and telemedicine campaign to rebuild awareness and demand among pre-menopausal women with initial geo-targeting to top prescriber and digital locations;
    • Completed enrollment of a Phase 2 clinical study with PL9643 for the treatment of dry eye disease (DED). Data readout expected December 2020;
    • A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is targeted to start in the first half of calendar year 2021.

    "We have made significant progress and improvement on Vyleesi commercial activities, specifically around insurance reimbursement and expanded coverage. This put us in the proper position as we initiated a targeted marketing digital campaign to raise condition and treatment awareness with premenopausal women," stated Carl Spana, Ph.D., President and CEO of Palatin.

    "Despite the challenges posed by the ongoing viral pandemic, we are on track for data readout next month on our PL9643 Phase 2 clinical study in subjects with dry eye disease. Most people living with dry eye disease suffer from episodic flare-ups. These flares can be caused by a multitude of triggers and frequently are not sufficiently addressed by current therapies."

    Programs Overview

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

    In July 2020, Palatin announced the mutual termination of its License Agreement with AMAG Pharmaceutical, Inc, for Vyleesi. Under the termination agreement, Palatin regained all North American development and commercialization rights for Vyleesi. AMAG made a $12.0 million payment to Palatin at closing and will make a $4.3 million payment to Palatin on March 31, 2021. Palatin assumed all Vyleesi manufacturing agreements, and AMAG transferred information, data, and assets related exclusively to Vyleesi, including existing inventory. AMAG is providing certain transitional services to Palatin for a period to ensure continued patient access to Vyleesi and regulatory compliance during the transition back to Palatin. Palatin is reimbursing AMAG for the agreed upon costs of the transition services.

    Palatin is exploring its options to enhance the commercialization of Vyleesi, including discussions with potential collaboration partners that currently market female healthcare products. Palatin continues collaboration discussions for territories outside the currently licensed territories of China and Korea and anticipates executing multiple agreements through calendar year 2021.

    The Company's strategy implements an informed and highly targeted approach to marketing, focusing on 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. Patients also can connect with a healthcare provider through telemedicine. 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 for 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.

    Anti-Inflammatory / Autoimmune Programs

    Enrollment in a Phase 2 clinical study with PL9643 for the treatment of dry eye disease was completed in August 2020. Data readout is targeted for December of 2020. If results from the Phase 2 study support advancing to Phase 3, the Company will initiate a Phase 3 efficacy study as early as mid-calendar year 2021.

    A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is targeted to start in the first half of calendar year 2021, with data readout potentially 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 investigational new drug (IND) filing 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 the FDA granted orphan drug designation, in the second half of calendar year 2021.

    Palatin is advancing its COVID-19 development plan and is conducting all the required activities needed to file an IND and begin clinical studies with PL8177 as a treatment in COVID-19 patients. These activities will be completed in the fourth calendar quarter of 2020, allowing the Company to potentially file an IND with the FDA and initiate a clinical study of PL8177 for the treatment of COVID-19 patients early in the first calendar quarter of 2021.

    The landscape for treating and conducting clinical studies in COVID-19 patients is rapidly evolving. This impacts the design, risk, and ability to conduct clinical studies in COVID-19 patients.  Considering the risk and uncertainty of conducting COVID-19 clinical studies, the start of a PL8177 clinical study is subject to receiving external funding and operational support. The Company is in the process of applying to government programs that provide such support.

    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. Patient enrollment in the study has commenced and the first patient was dosed in November 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.

    Conference Call / Webcast

    Palatin will host a conference call and audio webcast on November 17, 2020 at 11:00 a.m. Eastern Time to discuss the quarter ended September 30, 2020 results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-800-353-6461 (US/Canada) or 1-334-323-0501 (international), conference ID 3383273. 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 3383273. The webcast and telephone replay will be available through November 24, 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, Palatin's ongoing relationship with AMAG, 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® and Vyleesi® are registered trademarks of Palatin Technologies, Inc.

     



    PALATIN TECHNOLOGIES, INC.

    and Subsidiary

    Consolidated Statements of Operations

    (unaudited)













    Three Months Ended September 30,





    2020



    2019













    REVENUES









    Product revenue, net

    $                    (288,560)



    $                              -



    License and contract

    -



    97,379





    (288,560)



    97,379



    OPERATING EXPENSES









        Cost of products sold

    25,200



    -



    Research and development

    2,923,851



    3,127,489



    Selling, general and administrative

    2,331,606



    1,832,442



    Gain on license termination agreement

    (1,623,795)



    -



    Total operating expenses

    3,656,862



    4,959,931













    Loss from operations

    (3,945,422)



    (4,862,552)













    OTHER INCOME (EXPENSE)









    Investment income

    12,135



    370,654



    Interest expense

    (7,489)



    (9,051)



    Total other income, net

    4,646



    361,603



    NET LOSS

    $                 (3,940,776)



    $                (4,500,949)























    Basic and diluted net loss per common share

    $                          (0.02)



    $                         (0.02)



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

    236,345,862



    233,113,241



     

    PALATIN TECHNOLOGIES, INC.

    and Subsidiary

    Consolidated Balance Sheets

    (unaudited)











    September 30, 2020



    June 30, 2020

    ASSETS







    Current assets:







    Cash and cash equivalents

    $                  86,587,455



    $      82,852,270

    Accounts receivable

    5,044,372



    -

    Inventories

    5,792,595



    -

    Prepaid expenses and other current assets

    2,360,001



    738,216

    Total current assets

    99,784,423



    83,590,486









    Property and equipment, net

    126,772



    140,216

    Right-of-use assets

    1,190,410



    1,266,132

    Other assets

    56,916



    56,916

    Total assets

    $                101,158,521



    $      85,053,750









    LIABILITIES AND STOCKHOLDERS' EQUITY 







    Current liabilities:







    Accounts payable 

    $                       971,308



    $           715,672

    Accrued expenses

    3,823,682



    2,899,097

    Short-term operating lease liabilities

    282,275



    312,784

    Other current liabilities

    7,575,000



    -

    Total current liabilities

    12,652,265



    3,927,553









    Long-term operating lease liabilities

    911,775



    953,348

    Other long-term liabilities

    10,619,000



    -

    Total liabilities

    24,183,040



    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 September 30, 2020 and June 30, 2020

    40



    40

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







    issued and outstanding 229,855,417 shares as of September 30, 2020 and 229,258,400 shares as of June 30, 2020 

    2,298,554



    2,292,584

    Additional paid-in capital

    396,816,565



    396,079,127

    Accumulated deficit 

    (322,139,678)



    (318,198,902)

    Total stockholders' equity 

    76,975,481



    80,172,849

    Total liabilities and stockholders' equity

    $                101,158,521



    $      85,053,750









                            

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/palatin-technologies-inc-reports-first-quarter-fiscal-year-2021-results-and-provides-business-update-301174169.html

    SOURCE Palatin Technologies, Inc.

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  3. CRANBURY, N.J., Nov. 12, 2020 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN) will announce its first quarter, fiscal year 2021 operating results on Tuesday, November 17, 2020 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 17, 2020 at 11:00 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 2021 Results Press Release                         

    11/17/2020 at 7:30 a.m. ET





    Q1 Fiscal Year 2021 Conference Call-Live                           

    11/17/2020 at 11:00 a.m. ET

    US/Canada Dial-In Number:                                                 

    1-800-353-6461

    International Dial-In Number:                                               

    1-334-323-0501

    Conference ID:                                                                    

    3383273





    Q1 Fiscal Year 2021 Conference Call-Replay                   

    11/17/2020-11/24/2020

    US/Canada Dial-In Number:                                             

    1-888-203-1112

    International Dial-In Number:                                           

    1-719-457-0820

    Replay Passcode:                                                           

    3383273





    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 Technologies, Inc.

    Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics 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, please visit http://www.palatin.com.

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    SOURCE Palatin Technologies, Inc.

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  4. CRANBURY, N.J., Sept. 28, 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 financial results for its fourth quarter and fiscal year ended June 30, 2020.

    Fourth Quarter and Fiscal Year 2020 Financial Highlights

    • Net loss for the fourth quarter ended June 30, 2020 was $(7.3) million, or $(0.03) per basic and diluted share, compared to net income of $52.2 million, or $0.25 per basic and $0.23 per diluted share for the comparable quarter of 2019;
    • Net loss for the year ended June 30, 2020 was $(22.4) million, or $(0.10) per basic and diluted share, compared to net income of $35.8 million, or $0.17 per basic and $0.16 per diluted share for the year ended June 30, 2019;
    • The difference between the quarter and year ended June 30, 2020 compared to the quarter and year ended June 30, 2019 was due to the recognition of license and contract revenue pursuant to our license agreement with AMAG of $60.3 million for the quarter and year ended June 30, 2019;
    • As of June 30, 2020, the Company had $82.9 million in cash and cash equivalents, compared to $43.5 million as of June 30, 2019, and no debt.

    Recent Business Highlights and Updates

    • In July 2020 mutually terminated the January 2017 license agreement granting AMAG Pharmaceuticals ("AMAG") exclusive North American rights to market Vyleesi® (bremelanotide), the first and only on demand treatment for premenopausal women suffering from acquired, generalized, hypoactive sexual desire disorder (HSDD), a condition affecting one in ten premenopausal women;
    • Completed enrollment of a Phase 2 clinical study with PL9643 for the treatment of dry eye disease (DED). Final patient and topline data readout is targeted for the fourth calendar quarter of 2020;
    • A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is targeted to start in the first half of calendar year 2021.

    "We are pleased to have completed enrollment last month in our PL9643 Phase 2 clinical study in subjects with dry eye disease. Data readout is targeted for the fourth calendar quarter of 2020. We believe that, if approved, PL9643's potentially quick onset to efficacy and favorable tolerability and safety profile may provide a treatment option to the millions of individuals suffering from DED," stated Carl Spana, Ph.D., President and CEO of Palatin.

    "We believe that Vyleesi is an important treatment for the millions of premenopausal women suffering from HSDD. Our goal with the Vyleesi program is to demonstrate value in the marketplace by increasing patient demand and access. Our objective is to re-license the U.S. rights to a committed women's healthcare company. Having taken steps to ensure no disruption for patient access to Vyleesi, we are working to expand awareness of the condition and treatment in a highly-targeted and informed manner, enhance and stream-line patient access, and increase insurance coverage."

    Dr. Spana further commented, "Our strong cash position of $83 million at June 30, 2020 and no debt, coupled with the $12 million received in July 2020 from AMAG, plus an additional $4.3 million due from AMAG March 31, 2021, provides us the financial resources to significantly advance our Anti-Inflammatory and Autoimmune programs, and make complimentary targeted investments to our Vyleesi program."

    "The entire Palatin team thanks healthcare workers across the nation for their selfless efforts in the treatment and care of COVID-19 patients.  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," continued Spana. "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."

    Programs Overview

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

    In July 2020, Palatin announced the mutual termination of its License Agreement with AMAG for Vyleesi. Under the terms of the termination agreement, Palatin regained all North American development and commercialization rights for Vyleesi. AMAG made a $12.0 million payment to Palatin at closing and will make a $4.3 million payment to Palatin on March 31, 2021. Palatin assumed 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 and regulatory compliance during the transition back to Palatin. Palatin will reimburse AMAG for the agreed upon costs of the transition services.

    Palatin is exploring its options pertaining to enhancing the commercialization of Vyleesi, including but not limited to, discussions with potential collaboration partners that currently market female healthcare products. Palatin continues collaboration discussions for territories outside the currently licensed territories of China and Korea and anticipates executing multiple agreements through calendar year 2021.

    In the interim, the Company's strategy implements an informed and highly targeted approach to marketing, focusing on 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. Patients also have the ability to connect with a healthcare provider through telemedicine. 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 for 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.

    Anti-Inflammatory / Autoimmune Programs

    Enrollment in a Phase 2 clinical study with PL9643 was completed in August 2020. Data readout is targeted for the fourth calendar quarter of 2020. If results from the Phase 2 study support advancing to Phase 3, the Company will initiate a Phase 3 efficacy study as early as mid-calendar year 2021.

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

    Palatin is advancing its COVID-19 development plan and is conducting all the required activities needed to file an IND and begin clinical studies with PL8177 in COVID-19 patients. These activities will be completed in the fourth calendar quarter of 2020, allowing the Company to potentially file an IND with the FDA and initiate a clinical study of PL8177 for the treatment of COVID-19 patients early in the first calendar quarter of 2021.

    The landscape for treating and conducting clinical studies in COVID-19 patients is rapidly evolving. This impacts the design, risk, and ability to conduct clinical studies in COVID-19 patients.  Considering the risk and uncertainty of conducting COVID-19 clinical studies, the start of a PL8177 clinical study is subject to receiving external funding and operational support. The Company is in the process of applying to government programs that provide such support.

    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 fourth calendar quarter of 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.

    Fourth Quarter and Fiscal Year 2020 Financial Results

    Revenue

    Palatin recognized no revenues for the quarter ended June 30, 2020 and $117,989 in license and contract revenue for the year ended June 30, 2020 related to our license agreement with AMAG.

    For the quarter and year ended June 30, 2019, Palatin recognized $60.3 million in license and contract revenue related to our license agreement with AMAG.

    Operating Expenses

    Total operating expenses for the quarter ended June 30, 2020 were $7.4 million compared to $8.1 million for the comparable quarter of 2019.  The decrease in operating expenses was due to the overall reduction in research and development expenses and a decrease in general and administrative expenses.

    For the year ended June 30, 2020, Palatin incurred $23.7 million of operating expenses, compared to $24.6 million for the year ended June 30, 2019. The decrease in operating expenses was 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, for the quarter and year ended June 30, 2020 was $90,667 and $1.2 million, respectively.

    Total other income, net, for the quarter and year ended June 30, 2019 was $38,476 and $28,707, respectively. 

    The difference is related primarily to the increase in investment income and secondarily to the decrease in interest expense related to venture debt.

    Cash Position

    Palatin's cash and cash equivalents were $82.9 million with no accounts receivable as of June 30, 2020, compared to cash and cash equivalents of $43.5 with accounts receivable of $60.3 million at June 30, 2019. 

    Management believes that its existing capital resources will be sufficient to fund the Company's planned operations through at least September 30, 2021.

    Conference Call / Webcast

    Palatin will host a conference call and audio webcast on September 28, 2020 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 1-800-353-6461 (US/Canada) or 1-334-323-0501 (international), conference ID 6978729. 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 6978729. The webcast and telephone replay will be available through October 5, 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, Palatin's ongoing relationship with AMAG, 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 Palatin Technologies, Inc.

    PALATIN TECHNOLOGIES, INC.

    and Subsidiary

    Consolidated Statements of Operations

    (unaudited)



















    Three Months Ended June 30,



    Year Ended June 30,



    2020



    2019



    2020



    2019

















    REVENUES















    License and contract

    $                 -



    $   60,265,971



    $       117,989



    $   60,300,476

















    OPERATING EXPENSES















    Research and development

    3,933,034



    4,328,766



    13,959,397



    14,857,095

    General and administrative

    3,456,805



    3,751,118



    9,765,372



    9,699,061

    Total operating expenses

    7,389,839



    8,079,884



    23,724,769



    24,556,156

















    (Loss) income from operations

    (7,389,839)



    52,186,087



    (23,606,780)



    35,744,320

















    OTHER INCOME (EXPENSE)















    Investment income

    98,977



    85,056



    1,200,898



    446,268

    Interest expense

    (8,310)



    (46,580)



    (20,141)



    (417,561)

    Total other income (expense), net

    90,667



    38,476



    1,180,757



    28,707

















    (Loss) income before income taxes

    (7,299,172)



    52,224,563



    (22,426,023)



    35,773,027

    Income tax expense

    -



    -



    -



    -

    NET (LOSS) INCOME

    $   (7,299,172)



    $   52,224,563



    $ (22,426,023)



    $   35,773,027

































    Basic net (loss) income per common share

    $           (0.03)



    $              0.25



    $            (0.10)



    $              0.17

















    Diluted net (loss) income per common share

    $            (0.03)



    $              0.23



    $            (0.10)



    $              0.16

















    Weighted average number of common shares outstanding used in computing basic net (loss) income per common share

    235,394,831



    212,253,194



    234,684,776



    207,670,607

















    Weighted average number of common shares outstanding used in computing diluted net (loss) income per common share

    235,394,831



    228,526,106



    234,684,776



    217,133,374

     

    PALATIN TECHNOLOGIES, INC.

    and Subsidiary

    Consolidated Balance Sheets

    (unaudited)











    June 30, 2020



    June 30, 2019

    ASSETS







    Current assets:







    Cash and cash equivalents

    $               82,852,270



    $      43,510,422

    Accounts receivable

    -



    60,265,970

    Prepaid expenses and other current assets

    738,216



    637,289

    Total current assets

    83,590,486



    104,413,681









    Property and equipment, net

    140,216



    141,539

    Right-of-use assets *

    1,266,132



    -

    Other assets

    56,916



    179,916

    Total assets

    $               85,053,750



    $    104,735,136









    LIABILITIES AND STOCKHOLDERS' EQUITY 







    Current liabilities:







    Accounts payable 

    $                    715,672



    $           504,787

    Accrued expenses

    2,899,097



    2,848,692

    Notes payable, net of discount

    -



    332,896

    Short-term operating lease liabilities *

    312,784



    -

    Other current liabilities

    -



    499,517

    Total current liabilities

    3,927,553



    4,185,892









    Long-term operating lease liabilities *

    953,348



    -

    Total liabilities

    4,880,901



    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 June 30, 2020 and June 30, 2019

    40



    40

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







    issued and outstanding 229,258,400 shares as of June 30, 2020 and 226,815,363 shares as of June 30, 2019 

    2,292,584



    2,268,154

    Additional paid-in capital

    396,079,127



    394,053,929

    Accumulated deficit 

    (318,198,902)



    (295,772,879)

    Total stockholders' equity 

    80,172,849



    100,549,244

    Total liabilities and stockholders' equity

    $               85,053,750



    $    104,735,136









    * In the first quarter of fiscal 2020, the Company adopted Accounting Standards Update No. 2016-02,Leases. Under the new standard, lessees are required to recognize right-of-use assets and lease liabilities on the balance sheet for all leases. The Company adopted this standard using a modified retrospective transition method and elected the option to not restate comparative periods.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/palatin-technologies-inc-announces-fourth-quarter-and-fiscal-year-2020-financial-results-and-provides-a-business-update-301138704.html

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  5. CRANBURY, N.J., Sept. 24, 2020 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN) will announce its fourth quarter and fiscal year end 2020 operating results on Monday, September 28, 2020 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 September 28, 2020 at 11:00 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

    Q4 and Fiscal Year End 2020 Financial Results Press Release       

    9/28/2020 at 7:30 a.m. ET





    Q4 and Fiscal Year End 2020 Conference Call-Live                       

    9/28/2020 at 11:00 a.m. ET

    US/Canada Dial-In Number:                                                           

    1-800-353-6461

    International Dial-In Number:                                                        

    1-334-323-0501

    Conference ID:                                                                                

    6978729





    Q4 and Fiscal Year End 2020 Conference Call-Replay                   

    9/28/2020-10/05/2020

    US/Canada Dial-In Number:                                                           

    1-888-203-1112

    International Dial-In Number:                                                        

    1-719-457-0820

    Replay Passcode:                                                                            

    6978729





    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 Technologies, Inc.

    Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics 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, please visit http://www.palatin.com.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/palatin-technologies-inc-to-report-fourth-quarter-and-fiscal-year-end-2020-results-teleconference-and-webcast-to-be-held-on-september-28-2020-301137862.html

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