1. CRANBURY, N.J., Feb. 17, 2021 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, today announced results for its second quarter ended December 31, 2020.

    Second Quarter Ended December 31, 2020 Financial Highlights

    • Net loss for the quarter was $(10.0) million, or $(0.04) per share, compared to a net loss of $(5.2) million, or $(0.02) per share for the comparable quarter of 2019;
      • The increase in net loss was primarily attributable to commercial expenses related to Vyleesi and to PL9643's Phase 2 study for the treatment of dry eye disease.
    • As of December 31, 2020, the Company had $72.2 million in cash and cash equivalents and $4.7 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

    • Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi® (bremelanotide injection)
      • Vyleesi gross sales for the quarter ended December 31, 2020 amounted to $943,950. Vyleesi product revenue was $(163,971), net of allowances and accruals. Vyleesi gross sales for the period July 25 to September 30 amounted to $809,100. Vyleesi product revenue was $(288,560), net of allowances and accruals;
      • Restructured the distribution network and procedures improving the patient experience; expanded 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 a geo-targeting approach.
    • Anti-Inflammatory / Autoimmune Programs
      • Announced positive results in its Phase 2 study of PL9643 for the treatment of dry eye disease (DED);
        • Announced statistically significant improvements in multiple signs and symptoms 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.
        • 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.
      • A Phase 2/3 Clinical trial with PL9643 for the treatment of DED is currently planned for mid-calendar year 2021;
      • Filed an international patent application under the Patent Cooperation Treaty (PCT) directed to the composition of PL9643 and a related family of melanocortin agonist peptides; and
      • A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is targeted to start mid-calendar year 2021, with data readout potentially in mid-calendar year 2022.

    "Working through the melanocortin system, PL9643 is a novel approach to treating dry eye disease. The emerging profile of PL9643, with its rapid therapeutic onset and excellent tolerability profile, is a potentially distinct advance in dry eye therapy," stated Carl Spana, Ph.D., President and CEO of Palatin. "The positive PL9643 Phase 2 study results identify the most appropriate patient population, endpoints, and timepoints for the next study, which is a Phase 2/3 study targeted for mid-calendar year 2021, with data readout in the first half of calendar year 2022. Regarding Vyleesi, our measured plan and investment is showing positive trends and returns with a significant rise in payer reimbursement and double-digit increases to month over month prescription numbers continuing through January 2021."

    Conference Call / Webcast

    Palatin will host a conference call and audio webcast on February 17, 2021 at 11:00 a.m. Eastern Time to discuss the quarter ended December 31, 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 1-866-248-8441 (US/Canada) or 1-856-344-9206 (international), conference ID 2203098. 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 2203098. The webcast and telephone replay will be available through February 24, 2021.

    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 market potential of Palatin's products, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, Palatin's ability to manufacture and market Vyleesi, 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, 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 December  31,



    Six Months Ended December 31,





    2020



    2019



    2020



    2019





















    REVENUES

















    Product revenue, net

    $                  (163,971)



    $                              -



    $                  (452,531)



    $                              -



    License and contract

    -



    20,610



    -



    117,989





    (163,971)



    20,610



    (452,531)



    117,989



    OPERATING EXPENSES

















        Cost of products sold

    29,400



    -



    54,600



    -



    Research and development

    4,011,418



    3,257,624



    6,935,269



    6,385,113



    Selling, general and administrative

    5,044,913



    2,404,093



    7,376,519



    4,236,535



    Gain on license termination agreement

    -



    -



    (1,623,795)



    -



    Total operating expenses

    9,085,731



    5,661,717



    12,742,593



    10,621,648





















    Loss from operations

    (9,249,702)



    (5,641,107)



    (13,195,124)



    (10,503,659)





















    OTHER (EXPENSE) INCOME 

















    Investment income

    4,800



    399,982



    16,935



    770,636



    Foreign currency loss

    (745,002)



    -



    (745,002)



    -



    Interest expense

    (1,871)



    (2,502)



    (9,360)



    (11,553)



    Total other (expense) income, net

    (742,073)



    397,480



    (737,427)



    759,083



    NET LOSS

    $               (9,991,775)



    $               (5,243,627)



    $             (13,932,551)



    $               (9,744,576)







































    Basic and diluted net loss per common share

    $                        (0.04)



    $                        (0.02)



    $                        (0.06)



    $                        (0.04)



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

    236,405,065



    234,923,592



    236,375,463



    234,018,417























    PALATIN TECHNOLOGIES, INC.

    and Subsidiary

    Consolidated Balance Sheets

    (unaudited)











    December 31, 2020



    June 30, 2020

    ASSETS







    Current assets:







    Cash and cash equivalents

    $               72,156,110



    $      82,852,270

    Accounts receivable

    4,746,623



    -

    Inventories

    6,031,088



    -

    Prepaid expenses and other current assets

    2,556,911



    738,216

    Total current assets

    85,490,732



    83,590,486









    Property and equipment, net

    116,362



    140,216

    Right-of-use assets

    1,113,685



    1,266,132

    Other assets

    56,916



    56,916

    Total assets

    $               86,777,695



    $      85,053,750









    LIABILITIES AND STOCKHOLDERS' EQUITY 







    Current liabilities:







    Accounts payable 

    $                 1,174,493



    $           715,672

    Accrued expenses

    4,799,561



    2,899,097

    Short-term operating lease liabilities

    265,339



    312,784

    Other current liabilities

    1,010,250



    -

    Total current liabilities

    7,249,643



    3,927,553









    Long-term operating lease liabilities

    855,626



    953,348

    Other long-term liabilities

    10,837,300



    -

    Total liabilities

    18,942,569



    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 December 31, 2020 and June 30, 2020

    40



    40

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







    issued and outstanding 230,034,307 shares as of December 31, 2020 and 229,258,400 shares as of June 30, 2020 

    2,300,343



    2,292,584

    Additional paid-in capital

    397,666,196



    396,079,127

    Accumulated deficit 

    (332,131,453)



    (318,198,902)

    Total stockholders' equity 

    67,835,126



    80,172,849

    Total liabilities and stockholders' equity

    $               86,777,695



    $      85,053,750









     

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  2. CRANBURY, N.J., Feb. 12, 2021 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN) will announce its second quarter, fiscal year 2021 operating results on Wednesday, February 17, 2021 before the open of the U.S. financial markets.

    Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on February 17, 2021 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

    Q2 Fiscal Year 2021 Results Press Release                  

    2/17/2021 at 7:30 a.m. ET





    Q2 Fiscal Year 2021 Conference Call-Live                      

    2/17/2021 at 11:00 a.m. ET

    US/Canada Dial-In Number:                                            

    1-866-248-8441

    International Dial-In Number:                                  

    1-856-344-9206

    Conference ID:                                                              

    2203098





    Q2 Fiscal Year 2021 Conference Call-Replay             

    2/17/2021-2/24/2021

    US/Canada Dial-In Number:                                            

    1-888-203-1112

    International Dial-In Number:                                        

    1-719-457-0820

    Replay Passcode:                                                           

    2203098





    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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  3. CRANBURY, N.J., Feb. 10, 2021 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor systems, today announced the filing of an international patent application under the Patent Cooperation Treaty (PCT) directed to the composition of PL9643 and a related family of melanocortin agonist peptides. 

    Palatin recently reported positive results in its Phase 2 study of PL9643 for the treatment of Dry Eye Disease (DED). Detailed study results will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting. A Phase 2/3 clinical trial with PL9643 for the treatment of DED is currently planned for mid-2021.

    The PCT application for PL9643 establishes the base for the presumptive patent term, and if a patent is granted which claims priority to this application, could provide patent protection for PL9643, and any product in which PL9643 is the active pharmaceutical ingredient, out to 2041, excluding any additional term for patent adjustment or patent term extension. 

    Palatin believes that the structure of PL9643 is novel and inventive. The International Search Authority will conduct a search and issue its Written Opinion on PL9643 and the related family of melanocortin agonist peptides, which will provide additional information on patentability of PL9643 and the related family.  We anticipate filing patent applications in the United States, Europe and a number of additional regions and countries throughout the world.

    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 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 patentability of PL9643 and the related family of melanocortin agonist peptides, 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, actions by patent offices in the United States and other countries, results of clinical trials, regulatory actions by  the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release.

     

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  4. CRANBURY, N.J., 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.

     

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  5. 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.

    View Full Article Hide Full Article
  6. 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.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/palatin-technologies-inc-to-report-first-quarter-fiscal-year-2021-results-teleconference-and-webcast-to-be-held-on-november-17-2020-301171701.html

    SOURCE Palatin Technologies, Inc.

    View Full Article Hide Full Article
  7. 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.

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  8. 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.

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  9. CRANBURY, N.J., Sept. 10, 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, announced today that it will be presenting at the H.C. Wainwright & Co., 22nd Annual Global Investment Conference on Monday, September 14, 2020 at 4:00 p.m. EDT.  The conference will be held virtually.

    Carl Spana, Ph.D., President and Chief Executive Officer of Palatin Technologies, will provide an update on Palatin's corporate and development programs.

    The presentation will be webcast and can be accessed by logging on to the "Investor/Webcasts" section of Palatin's website at http://www.palatin.com or by clicking the following link:  https://wsw.com/webcast/hcw7/ptn/1491682.  The webcast will be available for 90 days.

    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.

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  10. CRANBURY, N.J., Aug. 13, 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, announced that it participated in Canaccord Genuity's 40th Annual Growth Conference in a Fireside Chat today at 10:30 am ET.  The conference was held virtually.

    Carl Spana, Ph.D., President and Chief Executive Officer and Stephen T. Wills, Chief Financial Officer and Chief Operating Officer of Palatin Technologies, participated in the Fireside Chat hosted by John Newman of Canaccord Genuity.

    The Fireside Chat was webcast.  The webcast replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin's website at http://www.palatin.com or by clicking the following link:  https://wsw.com/webcast/canaccord42/ptn/.  The webcast will be available for 90 days.

    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.

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  11. CRANBURY, N.J., Aug. 5, 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 completion of enrollment of its Phase 2 study with PL9643 for the treatment of dry eye disease (DED).

    After delaying enrollment of new patient groups due to the COVID-19 pandemic, Palatin reinitiated enrollment in its PL9643 Phase 2 clinical study in subjects with dry eye disease last month.  With enrollment completed, data readout is targeted for the fourth quarter of calendar year 2020.

    "We are pleased to complete enrollment in this Phase 2 study. We believe that, if approved,  PL9643's potentially quick onset to efficacy and favorable tolerability and safety profile may provide a viable treatment option to the significant percentage of patients not refilling their prescriptions for some DED drugs after their initial use," commented Carl Spana, Ph.D., President and CEO of Palatin.

    The Phase 2 study is a multi-center, randomized double-masked and placebo-controlled study evaluating the efficacy and safety of PL9643 ophthalmic solution (topical eye drops) compared to placebo for the treatment of the signs and symptoms of dry eye. The study is designed to enroll up to 150 participants at three sites in the US. Patients were randomized in a 1:1 ratio into two arms, PL9643 or placebo, and undergo 12-weeks of treatment. The two primary endpoints are inferior corneal fluorescein staining and ocular discomfort. There are several secondary and exploratory outcome measures as well. For more information about the study, including inclusion/exclusion criteria, a clinical trial synopsis can be found on clinicaltrials.gov (NCT04268069).

    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, market potential for product candidates, Palatin's ability to market and commercialize Vyleesi® (bremelanotide injection) in the United States, 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, 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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  12. 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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  13. 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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  14. 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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  15. 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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  16. 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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  17. CRANBURY, N.J., May 7, 2020 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN) will announce its third quarter fiscal year 2020 operating results on Tuesday, May 12, 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 May 12, 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

    Q3 Fiscal Year 2020 Financial Results Press Release     

    5/12/2020 at 7:30 a.m. ET



    Q3 Fiscal Year 2020 Conference Call-Live

    5/12/2020 at 11:00 a.m. ET

    US/Canada Dial-In Number:

    1-888-204-4368

    International Dial-In Number:

    1-323-994-2082

    Conference ID:

    8845359



    Q3 Fiscal Year 2020 Conference Call-Replay 

    5/12/2020-5/19/2020

    US/Canada Dial-In Number:

    1-888-203-1112

    International Dial-In Number:

    1-719-457-0820

    Replay Passcode:

    8845359



    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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  18. CRANBURY, N.J., April 30, 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 provided an update on business operations as a result of the global COVID-19 pandemic.

    The Company has taken steps to ensure the safety and well-being of its employees and clinical trial patients to comply with guidance from federal, state and local authorities, while working to ensure the sustainability of its business operations as this unprecedented situation continues to evolve.

    In mid-March, the Company transitioned to a company-wide work from home policy. Business-critical activities continue to be subject to heightened precautions to ensure safety of employees. The Company continues to assess its policies, business continuity plans and employee support.

    The Company continues to evaluate the impact of COVID-19 on the healthcare system and work with contract research organizations supporting its clinical, research, and development programs to mitigate risk to patients and its business and community partners, taking into account regulatory, institutional, and government guidance and policies.

    Impact of COVID-19 Pandemic Related to Ongoing Programs and Development

    Management Statement on COVID-19 Pandemic Impact on Operations
    During this pandemic, the safety of Palatin's employees, clinical trial patients and healthcare partners has been the Company's number one priority. Assuming partial opening of economic activities by mid-2020, senior management believes there will be limited impact of the pandemic on operations.  However, senior management understands there can be further disruptions to business activity based on resurgence of the virus and will take steps to be as prepared as possible for this potential outcome.

    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 remains on track for the fourth quarter of calendar year 2020 (no delay on anticipated data readout due to COVID-19).

    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 (two quarter delay due to COVID-19).

    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 (no delay due to COVID-19). 

    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 (one quarter delay due to COVID-19).

    Hypoactive Sexual Desire Disorder ("HSDD") / Vyleesi® (bremelanotide injection)
    In January 2020 AMAG Pharmaceuticals, Inc. announced that, as a result of a strategic review, it will divest Vyleesi, which it exclusively licensed from Palatin for North America.

    Palatin will provide an update on May 12, 2020, when it reports its financial results for the first quarter of calendar 2020, regarding its rights under the license agreement, the status of AMAG's divestiture process as it relates to Palatin, and specificity around the impact of the COVID-19 pandemic on Vyleesi sales and marketing.

    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 (limited to no delay due to COVID-19).

    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 (one quarter delay due to COVID-19).

    Cash Position
    Palatin's cash and cash equivalents of $88.9 million as of March 31, 2020, represents cash runway of at least two years based on projected operations.

    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.

    Vyleesi® is a registered trademark of AMAG Pharmaceuticals, Inc. in North America and of Palatin Technologies, Inc. elsewhere in the world.

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  19. CRANBURY, N.J., Feb. 19, 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 enrolled the first patient in a Phase 2 clinical trial of topical PL9643, a melanocortin 1/5 receptor (MC1/5r) agonist, for the treatment of dry eye disease (DED).

    Palatin Technologies, Inc.

    "We are pleased to initiate 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. "Millions of people suffer from DED and the market…

    CRANBURY, N.J., Feb. 19, 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 enrolled the first patient in a Phase 2 clinical trial of topical PL9643, a melanocortin 1/5 receptor (MC1/5r) agonist, for the treatment of dry eye disease (DED).

    Palatin Technologies, Inc.

    "We are pleased to initiate 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. "Millions of people suffer from DED and the market is underserved, with a significant percentage of patients not refilling their prescriptions for some DED drugs after their initial use. We believe that PL9643's potentially quick onset to efficacy and more favorable tolerability and safety profile compared to existing treatments may allow for substantial penetration of the dry eye market. We expect to report data from this study in the fourth quarter of this calendar year."  

    The Phase 2 study is a multi-center, randomized double-masked and placebo-controlled study evaluating the efficacy and safety of PL9643 ophthalmic solution (topical eye drops) compared to placebo for the treatment of the signs and symptoms of dry eye. 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. The two primary endpoints are inferior corneal fluorescein staining and ocular discomfort. There are several secondary and exploratory outcome measures as well. For more information about the study, including inclusion/exclusion criteria, a clinical trial synopsis can be found on clinicaltrials.gov (NCT04268069).

    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, and market potential for product candidates, 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-inc-announces-first-patient-enrolled-in-dry-eye-disease-phase-2-clinical-trial-with-pl9643-301007187.html

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  20. CRANBURY, N.J., Feb. 11, 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, whose product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced results for its second quarter ended December 31, 2019.

    Palatin Technologies, Inc.

    "The June 2019 FDA approval of Vyleesi® was meaningful on two fronts," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "For premenopausal women, it provides a safe and effective, as-needed treatment option for those with…

    CRANBURY, N.J., Feb. 11, 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, whose product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced results for its second quarter ended December 31, 2019.

    Palatin Technologies, Inc.

    "The June 2019 FDA approval of Vyleesi® was meaningful on two fronts," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "For premenopausal women, it provides a safe and effective, as-needed treatment option for those with HSDD. For Palatin, we now have an enhanced cash position of $92 million at December 31, 2019, which puts us in an excellent position to advance our pipeline programs. We have two Phase 2 clinical studies starting in the first half of calendar year 2020: a dry eye disease study with data expected in the fourth quarter of calendar year 2020 and an ulcerative colitis trial with data expected in mid-calendar year 2021."

    "AMAG's planned divestiture of Vyleesi is based on its change in strategy, and is not a result of the Vyleesi launch performance to date," continued Spana. "As the licensor, we maintain certain rights and will take appropriate steps to ensure that the value of Vyleesi remains intact and continues to grow. We will also continue to be opportunistic and flexible as the divestiture process advances, with the objective that the ultimate licensee of the North American rights to Vylessi is committed to the robust commercialization of the product."

    Recent Business Highlights

    Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi® (bremelanotide injection)
    On January 9, 2020 AMAG Pharmaceuticals, Inc. ("AMAG") announced that, as a result of a strategic review, it will divest Vyleesi, which it exclusively licensed from Palatin for North America, and another female healthcare product, Intrarosa®. AMAG stated that it has received preliminary expressions of interest in these assets.

    Under the Vyleesi license agreement, AMAG has a contractual obligation to use commercially reasonable efforts to commercialize Vyleesi. If AMAG materially breaches this obligation and fails to cure such breach, Palatin could potentially have the right to terminate the license agreement and have Vyleesi returned to Palatin. In the event AMAG assigns its Vyleesi license, the assignee must expressly agree to be bound by the Vyleesi license agreement between AMAG and Palatin.

    Palatin is advancing discussions on Vyleesi collaborations for territories outside the currently licensed territories of North America, China, and Korea, and anticipates executing multiple agreements during calendar year 2020. Vyleesi is licensed to Fosun Pharma in China and Kwangdong Pharmaceuticals in South Korea. Both companies are advancing Vyleesi through the regulatory process in their respective territories, which includes the conduct of certain clinical studies in those territories prior to filing for market approval.

    Vyleesi is the first as-needed treatment approved for premenopausal women with acquired, generalized HSDD. AMAG Pharmaceuticals, Palatin's North American licensee, launched Vyleesi nationally in September 2019 through select specialty pharmacies with its established women's health sales force of approximately 125 sales representatives. While AMAG has not yet released prescription numbers for the quarter ended December 31, 2019, AMAG has stated publicly that the "Vyleesi launch is off to a strong start."

    Anti-Inflammatory / Autoimmune Programs
    Melanocortin agonist products are under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases (ulcerative colitis).

    An investigational new drug application (IND) for PL9643 in dry eye disease was filed with the US Food and Drug Administration (FDA) in December 2019. A Phase 2 clinical study is expected to commence in the first quarter of calendar year 2020, with data readout anticipated in 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 anticipated to start mid-calendar year 2020, with data readout mid-calendar year 2021.

    Palatin continues its assessment and development work related to the treatment of patients with diabetic retinopathy and non-infectious uveitis (NIU), an indication which FDA granted orphan drug designation, with the objective of commencing clinical trials in calendar year 2021.

    Natriuretic Peptide Receptor (NPR) System Program
    Palatin has designed and is developing potential drug candidates that are selective agonists for one or more different natriuretic peptide receptors, including natriuretic peptide receptor-A (NPR-A), natriuretic peptide receptor B (NPR-B), and natriuretic peptide receptor C (NPR-C).

    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 anticipated to start patient enrollment in 2020.

    PL3994 has potential utility in the treatment of a number of cardiovascular diseases, including genetic and orphan diseases resulting from a deficiency of endogenous active NPR-A. PL5028, a dual NPR-A and NPR-C agonist in development for cardiovascular diseases, has potential for reducing cardiac hypertrophy and fibrosis, among other indications.

    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.

    Second Quarter Fiscal Year 2020 Financial Results

    Revenue
    For the quarter ended December 31, 2019, Palatin recognized as revenue $20,610 in reimbursement of shared Vyleesi costs related to our license agreement with AMAG. There were no revenues recorded in the quarter ended December 31, 2018.

    Operating Expenses
    Total operating expenses for the quarter ended December 31, 2019 were $5.7 million compared to $5.1 million for the comparable quarter of 2018. The increase in operating expenses was mainly due to the final payment of $625,000 made in connection with the mutually agreed upon termination of our engagement agreement on Vyleesi with Greenhill & Co.

    Other Income/Expense, net
    Total other income was $397,480 for the quarter ended December 31, 2019 compared to total other income $7,871 for the quarter ended December 31, 2018. The difference is related primarily to the increase in investment income.

    Net Loss
    Palatin reported a net loss of $(5.2) million, or $(0.02) per basic and diluted share, for the quarter ended December 31, 2019, compared to a net loss of $(5.0) million, or $(0.02) per basic and diluted share, for the same period in 2018.

    The difference in financial results between the three months ended December 31, 2019 and 2018 was attributable to the increase in operating expenses of $0.6 million offset by the increase of $0.4 million in other income.

    Cash Position
    Palatin's cash, cash equivalents, and accounts receivable total $91.6 million as of December 31, 2019, compared to cash, cash equivalents, and accounts receivable of $103.8 million at June 30, 2019. Current liabilities were $1.4 million as of December 31, 2019, compared to $4.2 million as of June 30, 2019.

    Conference Call / Webcast
    Palatin will host a conference call and audio webcast on February 11, 2020 at 11:00 a.m. Eastern Time to discuss the results of operations for the quarter ended December 31, 2019 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 7551093. 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 7551093. The webcast and telephone replay will be available through February 18, 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, and market potential for product candidates, 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.

    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 December 31,


    Six Months Ended December 31,


    2019


    2018


    2019


    2018









    REVENUES








    License and contract

    $          20,610


    $                  -


    $        117,989


    $          34,505









    OPERATING EXPENSES








    Research and development

    3,257,624


    2,961,656


    6,385,113


    6,584,347

    General and administrative

    2,404,093


    2,088,565


    4,236,535


    4,129,147

    Total operating expenses

    5,661,717


    5,050,221


    10,621,648


    10,713,494









    Loss from operations

    (5,641,107)


    (5,050,221)


    (10,503,659)


    (10,678,989)









    OTHER INCOME (EXPENSE)








    Investment income

    399,982


    100,169


    770,636


    253,752

    Interest expense

    (2,502)


    (92,298)


    (11,553)


    (299,169)

    Total other income (expense), net

    397,480


    7,871


    759,083


    (45,417)









    NET LOSS

    $    (5,243,627)


    $    (5,042,350)


    $    (9,744,576)


    $  (10,724,406)









    Basic and diluted  net loss per common share

    $             (0.02)


    $             (0.02)


    $             (0.04)


    $             (0.05)









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

    234,923,592


    206,487,984


    234,018,417


    205,724,321









     

    PALATIN TECHNOLOGIES, INC.

    and Subsidiary

    Consolidated Balance Sheets

    (unaudited)






    December 31, 2019


    June 30, 2019

    ASSETS




    Current assets:




    Cash and cash equivalents

    $              91,459,480


    $      43,510,422

    Accounts receivable

    117,989


    60,265,970

    Prepaid expenses and other current assets

    656,599


    637,289

    Total current assets

    92,234,068


    104,413,681





    Property and equipment, net

    167,913


    141,539

    Right-of-use assets

    173,666


    -

    Other assets

    179,916


    179,916

    Total assets

    $              92,755,563


    $    104,735,136





    LIABILITIES AND STOCKHOLDERS' EQUITY 




    Current liabilities:




    Accounts payable 

    $                   135,171


    $           504,787

    Accrued expenses

    1,079,591


    2,848,692

    Notes payable, net of discount

    -


    332,896

    Other current liabilities

    160,178


    499,517

    Total current liabilities

    1,374,940


    4,185,892





    Other liabilities

    13,488


    -

    Total liabilities

    1,388,428


    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 December 31, 2019 and June 30, 2019

    40


    40

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




    issued and outstanding 229,174,754 shares as of December 31, 2019 and
    226,815,363 shares as of June 30, 2019 

    2,291,748


    2,268,154

    Additional paid-in capital

    394,592,802


    394,053,929

    Accumulated deficit 

    (305,517,455)


    (295,772,879)

    Total stockholders' equity 

    91,367,135


    100,549,244

    Total liabilities and stockholders' equity

    $              92,755,563


    $    104,735,136

     

     

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  21. CRANBURY, N.J., Feb. 6, 2020 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN) will announce its second quarter fiscal year 2020 operating results on Tuesday, February 11, 2020 before the open of the U.S. financial markets.

    Palatin Technologies, Inc.

    Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on February 11, 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.

     

    CRANBURY, N.J., Feb. 6, 2020 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN) will announce its second quarter fiscal year 2020 operating results on Tuesday, February 11, 2020 before the open of the U.S. financial markets.

    Palatin Technologies, Inc.

    Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on February 11, 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


    Q2 Fiscal Year 2020 Financial Results Press Release                     

    2/11/2020 at 7:30 a.m. ET



    Q2 Fiscal Year 2020 Conference Call-Live                                     

    2/11/2020 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:                                                                                

    7551093



    Q2 Fiscal Year 2020 Conference Call-Replay                                 

    2/11/2020-2/18/2020

    US/Canada Dial-In Number:                                                           

    1-888-203-1112

    International Dial-In Number:                                                        

    1-719-457-0820

    Replay Passcode:                                                                            

    7551093



    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-second-quarter-fiscal-year-2020-results-teleconference-and-webcast-to-be-held-on-february-11-2020-300999918.html

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  22. CRANBURY, N.J., Jan. 21, 2020 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN), a biopharmaceutical company developing targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today provided a corporate update and outlook for calendar year 2020. 

    Palatin Technologies, Inc.

    "2019 was pivotal for Palatin - we had a major achievement with the FDA approval of Vyleesi® for the treatment of HSDD in premenopausal women, which resulted in the receipt of a $60 million milestone payment," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "The FDA approval was also significant for premenopausal women, as they now have a safe and effective as-needed treatment option available…

    CRANBURY, N.J., Jan. 21, 2020 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN), a biopharmaceutical company developing targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today provided a corporate update and outlook for calendar year 2020. 

    Palatin Technologies, Inc.

    "2019 was pivotal for Palatin - we had a major achievement with the FDA approval of Vyleesi® for the treatment of HSDD in premenopausal women, which resulted in the receipt of a $60 million milestone payment," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "The FDA approval was also significant for premenopausal women, as they now have a safe and effective as-needed treatment option available to them. Our enhanced cash position, which was $92 million at December 31, 2019, puts us in an excellent position to advance our pipeline programs. We have two Phase 2 clinical studies starting in the first half of calendar year 2020: a dry eye disease study with data expected in the fourth quarter of calendar year 2020 and an ulcerative colitis trial with data expected in mid-calendar year 2021."

    On January 9, 2020 AMAG Pharmaceuticals, Inc. ("AMAG") announced that, as a result of a strategic review, it will divest Vyleesi, which it exclusively licensed from Palatin for North America, and another female healthcare product, Intrarosa®. AMAG stated that it has received preliminary expressions of interest in these assets.

    Under the Vyleesi license agreement, AMAG has a contractual obligation to use commercially reasonable efforts to commercialize Vyleesi. If AMAG materially breaches this obligation and fails to cure such breach, Palatin could potentially have the right to terminate the license agreement and require AMAG to assign and transfer its Vyleesi rights to Palatin. In the event AMAG assigns its Vyleesi license, the assignee must expressly agree to be bound by the Vyleesi license agreement between AMAG and Palatin.

    Dr. Spana further commented, "AMAG's planned divestiture of Vyleesi is based on its change in strategy and the early commercial stage of Vyleesi and is not a result of the launch performance to date. We have a good relationship with AMAG and understand its decision in the context of its overall strategy. That said, we will diligently protect our rights as the Vyleesi licensor and take appropriate steps to safeguard that the significant value of Vyleesi remains intact and continues to grow. We will also be opportunistic and flexible as the divestiture process advances, with the objective that the next owner of the North American rights to Vylessi is committed to the robust commercialization of the product."

    Overview of Programs and Calendar Year 2020 Outlook
    Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi® (bremelanotide injection)
    Vyleesi is the first as needed treatment approved for premenopausal women with acquired, generalized HSDD. AMAG Pharmaceuticals, Palatin's North American licensee, launched Vyleesi nationally in September through select specialty pharmacies with its established women's health sales force of approximately 125 sales representatives. While AMAG has not yet released prescription numbers for the quarter ended December 31, 2019, AMAG has stated publicly that the "Vyleesi launch is off to a strong start."

    Palatin is advancing discussions on Vyleesi collaborations for territories outside the currently licensed territories of North America, China, and Korea, and anticipates executing multiple agreements during calendar year 2020. Vyleesi is licensed to Fosun Pharma in China and Kwangdong Pharmaceuticals in South Korea. Both companies are advancing Vyleesi through the regulatory process in their respective territories, which includes the conduct of certain clinical studies in those territories prior to filing for market approval.

    Anti-Inflammatory / Autoimmune Programs
    Melanocortin agonist products are under development for the treatment of inflammatory and autoimmune diseases such as dry eye disease, uveitis, diabetic retinopathy and inflammatory bowel diseases (ulcerative colitis).

    An investigational new drug application (IND) for PL9643 in dry eye disease (DED) was filed with the US Food and Drug Administration (FDA) in December 2019. A Phase 2 clinical study is expected to commence in the first quarter of calendar year 2020, with data readout anticipated in 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 anticipated to commence mid-calendar year 2020, with data readout mid-calendar year 2021.

    Palatin continues its assessment and development work related to the treatment of patients with diabetic retinopathy and non-infectious uveitis (NIU) (FDA granted orphan drug designation for PL8177 in NIU), with the objective of commencing clinical trials in calendar year 2021.

    Natriuretic Peptide Receptor ("NPR") System Program
    Palatin has designed and is developing potential drug candidates that are selective agonists for one or more different natriuretic peptide receptors, including natriuretic peptide receptor-A ("NPR-A"), natriuretic peptide receptor B ("NPR-B"), and natriuretic peptide receptor C ("NPR-C").

    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 part of a collaboration with two major academic medical centers and is supported by an American Heart Association grant. The study is anticipated to start patient enrollment in 2020.

    PL3994 has potential utility in the treatment of a number of cardiovascular diseases, including genetic and orphan diseases resulting from a deficiency of endogenous active NPR-A, and PL5028, a dual NPR-A and NPR-C agonist in development for cardiovascular diseases, has potential for reducing cardiac hypertrophy and fibrosis, among other indications.

    Genetic Obesity Program
    The Company'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 designation, potential development and licensing.

    Corporate
    Cash and cash equivalents at December 31, 2019 amounted to $92 million. The Company has no outstanding debt.

    About Palatin Technologies
    Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific therapeutics for the treatment of diseases and conditions 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 and Intrarosa, Palatin's ongoing relationship with AMAG and ability to protect its rights as the Vyleesi licensor, and market potential for product candidates, 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.

    Vyleesi® is a registered trademark of AMAG Pharmaceuticals, Inc. in North America and of Palatin Technologies, Inc. elsewhere in the world.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/palatin-provides-corporate-update-and-2020-calendar-outlook-300989962.html

    SOURCE Palatin Technologies, Inc.

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  23. CRANBURY, N.J., Nov. 13, 2019 /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, whose product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced results for its first quarter ended September 30, 2019.

    Palatin Technologies, Inc.

    Quarter End and Recent Highlights

    Hypoactive Sexual Desire Disorder / Vyleesi™ (bremelanotide injection)
    Vyleesi is the first as needed treatment for premenopausal women with acquired, generalized HSDD.

    AMAG Pharmaceuticals, Palatin's North American…

    CRANBURY, N.J., Nov. 13, 2019 /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, whose product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced results for its first quarter ended September 30, 2019.

    Palatin Technologies, Inc.

    Quarter End and Recent Highlights

    Hypoactive Sexual Desire Disorder / Vyleesi™ (bremelanotide injection)
    Vyleesi is the first as needed treatment for premenopausal women with acquired, generalized HSDD.

    AMAG Pharmaceuticals, Palatin's North American licensee, launched Vyleesi nationally in September with its established women's health sales force of approximately 125 sales representatives. In the four weeks since the national launch, more than 1,300 healthcare providers have prescribed Vyleesi, which has resulted in more than 3,000 prescriptions received by AMAG's specialty pharmacy partners.

    Anti-Inflammatory / Autoimmune Programs
    Melanocortin agonist products are under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases (ulcerative colitis). We announced positive results of a micro-dose study of radiolabeled PL8177, a selective melanocortin receptor 1 ("MC1r") peptide agonist, using an oral, delayed-release, polymer formulation. The study met all primary and secondary endpoints. PL8177 has potential application in treatment of ulcerative colitis and other inflammatory bowel diseases. The FDA has granted orphan drug designation for PL8177 for the treatment of non-infectious intermediate, posterior, pan and chronic anterior uveitis. Non-infectious uveitis (NIU) is a group of inflammatory diseases that produces swelling and destroys eye tissue and can result in vision loss. A Phase 2 proof-of-concept clinical study with a systemic formulation in NIU patients is anticipated to commence in the first quarter of calendar year 2020. A Phase 2 proof-of-concept clinical study with an oral formulation in ulcerative colitis patients is anticipated to commence in the second quarter of calendar year 2020.

    An IND application for PL9643, a melanocortin peptide agonist, and commencement of a Phase 2 clinical study in dry eye disease, are currently anticipated in the first quarter of calendar year 2020.

    Natriuretic Peptide Receptor ("NPR") System Program
    The Company has designed and is developing potential drug candidates that are selective agonist for one or more different natriuretic peptide receptors, including natriuretic peptide receptor-A ("NPR-A"), natriuretic peptide receptor B ("NPR-B"), and natriuretic peptide receptor C ("NPR-C"). Active collaborations with several institutions are ongoing for PL3994, an NPR-A agonist that has potential utility in the treatment of a number of cardiovascular diseases, including genetic and orphan diseases resulting from a deficiency of endogenous active NPR-A, and PL5028, a dual NPR-A and NPR-C agonist in development for cardiovascular diseases, including reducing cardiac hypertrophy and fibrosis. A Phase 2A clinical trial evaluating PL3994 in heart failure patients with preserved left ventricular ejection fraction will begin enrollment in the latter half of calendar year 2019. This trial is supported by a grant from the American Heart Association. 

    Genetic Obesity Program
    The Company'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 designation and potential development.

    Corporate
    Cash, cash equivalents and accounts receivable balances at September 30, 2019 total $96.8 million.

    Debt and related liabilities were fully paid off in July 2019.

    In September 2019, the Company's Board of Directors approved a plan to offer to purchase and terminate certain outstanding common stock purchase warrants through privately negotiated transactions. The purchase and termination program has no time limit and may be suspended for periods or discontinued at any time.

    To date, the Company entered into several warrant termination agreements to repurchase and cancel previously issued warrants.   The Company repurchased and cancelled in the aggregate 6.5 million warrants at an aggregate buyback price of $2.5 million.

    First Quarter Fiscal 2020 Financial Results
    Palatin reported a net loss of $(4.5) million, or $(0.02) per basic and diluted share, for the quarter ended September 30, 2019, compared to a net loss of $(5.7) million, or $(0.03) per basic and diluted share, for the same period in 2018.

    The difference in financial results between the three months ended September 30, 2019 and 2018 was due to reductions in operating and interest expenses combined with increases in reported license and contract revenue and investment income.

    Revenue
    For the quarter ended September 30, 2019, Palatin recognized as revenue $97,379 in reimbursement of shared Vyleesi costs compared to $34,505 for the quarter ended September 30, 2018.

    Operating Expenses
    Total operating expenses for the quarter ended September 30, 2019 were $5.0 million compared to $5.7 million for the comparable quarter of 2018. The decrease in operating expenses was mainly attributable to decreases in salaries and other employee related expenses.

    Other Income/Expense
    Total other income, net was $361,603 for the quarter ended September 30, 2019 compared to total other expense, net of $(53,288) for the quarter ended September 30, 2018. The difference is primarily related to an increase in investment income and secondarily to a decrease in interest expense.

    Cash Position
    Palatin's cash, cash equivalents, and accounts receivable total $96.8 million as of September 30, 2019, compared to cash, cash equivalents and accounts receivable of $103.8 million at June 30, 2019. Current liabilities were $1.9 million as of September 30, 2019, compared to $4.2 million as of June 30, 2019.

    Palatin Drug Discovery and Development Programs
    During the conference call and webcast, management will update and discuss next steps in Palatin's portfolio of drug development programs. These include Palatin's melanocortin receptor agonist peptides for treatment of inflammatory indications and natriuretic peptide receptor agonist compounds for treatment of cardiovascular and fibrotic diseases.

    Conference Call / Webcast
    Palatin will host a conference call and audio webcast on November 13, 2019 at 11:00 a.m. Eastern Time to discuss the quarter ended September 30, 2019 results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-888-599-8686 (US/Canada) or 1-323-794-2575 (international), conference ID 1609183. 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 1609183. The webcast and telephone replay will be available through November 20, 2019.

    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 and market potential for product candidates, 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.

    Vyleesi™ is a 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 September 30



    2019


    2018







    REVENUES





    License and contract

    $             97,379


    $                    34,505







    OPERATING EXPENSES





    Research and development

    3,127,489


    3,622,691


    General and administrative

    1,832,442


    2,040,582


    Total operating expenses

    4,959,931


    5,663,273







    Loss from operations

    (4,862,552)


    (5,628,768)







    OTHER INCOME (EXPENSE)





    Investment income

    370,654


    153,583


    Interest expense

    (9,051)


    (206,871)


    Total other income (expense), net

    361,603


    (53,288)







    NET LOSS

    $       (4,500,949)


    $             (5,682,056)







    Basic  net loss per common share

    $                (0.02)


    $                      (0.03)







    Diluted net loss per common share

    $                (0.02)


    $                      (0.03)







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

    233,113,241


    205,009,278







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

    233,113,241


    205,009,278







     

     

    PALATIN TECHNOLOGIES, INC.

    and Subsidiary

    Consolidated Balance Sheets

    (unaudited)






    September 30, 2019


    June 30, 2019

    ASSETS




    Current assets:




    Cash and cash equivalents

    $                 96,698,232


    $      43,510,422

    Accounts receivable

    97,379


    60,265,970

    Prepaid expenses and other current assets

    597,853


    637,289

    Total current assets

    97,393,464


    104,413,681





    Property and equipment, net

    186,166


    141,539

    Right-of-use assets

    213,065


    -

    Other assets

    179,916


    179,916

    Total assets

    $                 97,972,611


    $    104,735,136





    LIABILITIES AND STOCKHOLDERS' EQUITY 




    Current liabilities:




    Accounts payable 

    $                        57,823


    $           504,787

    Accrued expenses

    1,579,460


    2,848,692

    Notes payable, net of discount

    -


    332,896

    Other current liabilities

    213,065


    499,517

    Total liabilities

    1,850,348


    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 September 30, 2019 and June 30, 2019

    40


    40

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




    issued and outstanding 227,697,257 shares as of September 30, 2019 and
    226,815,363 shares as of June 30, 2019 

    2,276,973


    2,268,154

    Additional paid-in capital

    394,119,078


    394,053,929

    Accumulated deficit 

    (300,273,828)


    (295,772,879)

    Total stockholders' equity 

    96,122,263


    100,549,244

    Total liabilities and stockholders' equity

    $                 97,972,611


    $    104,735,136





     

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/palatin-technologies-inc-reports-first-quarter-fiscal-year-2020-results-and-provides-corporate-update-300957000.html

    SOURCE Palatin Technologies, Inc.

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  24. CRANBURY, N.J., Nov. 7, 2019 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN) will announce its first quarter fiscal year 2020 operating results on Wednesday, November 13, 2019 before the open of the U.S. financial markets.

    Palatin Technologies, Inc.

    Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on November 13, 2019 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

    CRANBURY, N.J., Nov. 7, 2019 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN) will announce its first quarter fiscal year 2020 operating results on Wednesday, November 13, 2019 before the open of the U.S. financial markets.

    Palatin Technologies, Inc.

    Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on November 13, 2019 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 2020 Financial Results Press Release            

    11/13/2019 at 7:30 a.m. ET



    Q1 Fiscal Year 2020 Conference Call-Live                           

    11/13/2019 at 11:00 a.m. ET

    US/Canada Dial-In Number:                                         

    1-888-599-8686

    International Dial-In Number:                                        

    1-323-794-2575

    Conference ID:                                                               

    1609183



    Q1 Fiscal Year 2020 Conference Call-Replay                       

    11/13/2019-11/20/2019

    US/Canada Dial-In Number:                                                

    1-888-203-1112

    International Dial-In Number:                                           

    1-719-457-0820

    Replay Passcode:                                                               

    1609183



    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-first-quarter-fiscal-year-2020-results-teleconference-and-webcast-to-be-held-on-november-13-2019-300953467.html

    SOURCE Palatin Technologies, Inc.

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  25. NEW YORK, Sept. 12, 2019 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for CGC, MU, PTN, SINT, and TLRY.

    To see how InvestorsObserver's proprietary scoring system rates these stocks, view the InvestorsObserver's PriceWatch Alert by selecting the corresponding link.

    (Note: You may have…

    NEW YORK, Sept. 12, 2019 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for CGC, MU, PTN, SINT, and TLRY.

    To see how InvestorsObserver's proprietary scoring system rates these stocks, view the InvestorsObserver's PriceWatch Alert by selecting the corresponding link.

    (Note: You may have to copy this link into your browser then press the [ENTER] key.)

    InvestorsObserver's PriceWatch Alerts are based on our proprietary scoring methodology. Each stock is evaluated based on short-term technical, long-term technical and fundamental factors. Each of those scores is then combined into an overall score that determines a stock's overall suitability for investment.

     

    Cision View original content:http://www.prnewswire.com/news-releases/thinking-about-buying-stock-in-canopy-growth-micron-technology-palatin-technologies-sintx-technologies-or-tilray-300917017.html

    SOURCE InvestorsObserver

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  26. CRANBURY, N.J., Sept. 12, 2019 /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, whose product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced results for its fourth quarter and fiscal year ended June 30, 2019.

    Palatin Technologies, Inc.

    "The last year was a landmark one for Palatin. We are proud of the recent FDA approval of Vyleesi and the continued advancement of our pipeline programs," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "The…

    CRANBURY, N.J., Sept. 12, 2019 /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, whose product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced results for its fourth quarter and fiscal year ended June 30, 2019.

    Palatin Technologies, Inc.

    "The last year was a landmark one for Palatin. We are proud of the recent FDA approval of Vyleesi and the continued advancement of our pipeline programs," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "The FDA approval is an incredible achievement and milestone, and we are excited that premenopausal women now have a safe and effective, as-needed option available to them for the treatment of acquired, generalized HSDD. Our cash and accounts receivable balances at June 30, 2019 of $102 million is sufficient to cover planned operations through at least calendar year 2021. We remain focused on advancing discussions on Vyleesi collaborations for territories outside the currently licensed territories of North America, China, and Korea, and initiating multiple clinical trials for our pipeline programs over the next several quarters for the treatment of dry eye disease, non-infectious uveitis and ulcerative colitis."

    2019 Fiscal Year Highlights and Recent Events

    Hypoactive Sexual Desire Disorder / Vyleesi™ (bremelanotide injection)
    The U.S. Food and Drug Administration (FDA) granted marketing approval of AMAG Pharmaceuticals, Inc.'s New Drug Application (NDA) for Vyleesi™ (bremelanotide injection), a melanocortin receptor agonist developed by Palatin, indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The FDA's approval of the NDA on June 21, 2019 triggered a $60 million milestone payment to Palatin under its North American license agreement with AMAG that was received in July. Additionally, Palatin is entitled to receive tiered royalties on net sales ranging from high single-digit to low double-digit percentages, and sales milestones based on escalating annual net sales thresholds, the first of which is $25 million, triggered at annual net sales of $250 million.

    Vyleesi is the first as needed treatment for premenopausal women with acquired, generalized HSDD. Vyleesi is currently available through specialty pharmacies, Avella and BioPlus, and AMAG will launch Vyleesi nationally with its full sales force in mid-September.

    Anti-Inflammatory / Autoimmune Programs
    Melanocortin agonist products are under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases (ulcerative colitis).

    We announced positive results of a micro-dose study of radiolabeled PL8177, a selective melanocortin receptor 1 ("MC1r") peptide agonist, using an oral, delayed-release, polymer formulation. The study met all primary and secondary endpoints.  PL8177 has potential application in treatment of ulcerative colitis and other inflammatory bowel diseases. The FDA has granted orphan drug designation for PL8177 for the treatment of non-infectious intermediate, posterior, pan and chronic anterior uveitis. Non-infectious uveitis (NIU) is a group of inflammatory diseases that produces swelling and destroys eye tissue and can result in vision loss.  A Phase 2 proof-of-concept clinical study with a systemic formulation in NIU patients is anticipated to commence in the fourth quarter of calendar year 2019.  A Phase 2 proof-of-concept clinical study with an oral formulation in ulcerative colitis patients is anticipated to commence in the first quarter of calendar year 2020.

    An IND application for PL9643, a melanocortin peptide agonist, and commencement of a Phase 2 clinical study in dry eye disease, are currently anticipated in the first quarter of calendar year 2020.

    Natriuretic Peptide Receptor ("NPR") System Program
    The Company has designed and is developing potential drug candidates that are selective agonist for one or more different natriuretic peptide receptors, including natriuretic peptide receptor-A ("NPR-A"), natriuretic peptide receptor B ("NPR-B"), and natriuretic peptide receptor C ("NPR-C").  Active collaborations with several institutions are ongoing for PL3994, an NPR-A agonist that has potential utility in the treatment of a number of cardiovascular diseases, including genetic and orphan diseases resulting from a deficiency of endogenous active NPR-A, and PL5028, a dual NPR-A and NPR-C agonist in development for cardiovascular diseases, including reducing cardiac hypertrophy and fibrosis.  A Phase 2A clinical trial evaluating PL3994 in heart failure patients with preserved left ventricular ejection fraction will begin enrollment in the latter half of calendar year 2019. This trial is supported by a grant from the American Heart Association.

    Genetic Obesity Program
    The Company'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 designation and potential development.

    Corporate
    Cash and accounts receivable balances at June 30, 2019 of $102 million is sufficient to cover planned operations through at least calendar year 2021. Included in the accounts receivable balance is a $60 million milestone payment due from AMAG for the Vyleesi FDA approval, which was received in July 2019.

    Debt and related liabilities decreased from $7.2 million at June 30, 2018 to $0.8 million at June 30, 2019, with a final payment remitted in July 2019.

    Fourth Quarter and Fiscal 2019 Financial Results
    Palatin reported net income of $52.2 million, or $0.25 per basic and $0.23 per diluted share, for the fourth quarter ended June 30, 2019, compared to net income of $11.8 million, or $0.06 per basic and diluted share, for the same period in 2018.

    The difference between the three months ended June 30, 2019 and 2018 was attributable to the recognition of license and contract revenue pursuant to our license agreement with AMAG of $60.3 million for the quarter ended June 30, 2019 compared to $20.6 million in 2018.

    For the year ended June 30, 2019, Palatin reported net income of $35.8 million, or $0.17 per basic and $0.16 per diluted share, compared to net income of $24.7 million, or $0.12 per basic and diluted share for the year ended June 30, 2018.

    The difference in net income for the years ended June 30, 2019 and 2018, was primarily the result of a $16.6 million decrease in operating expenses to $24.6 million for the year ended June 30, 2019, compared to $41.2 million for the year ended June 30, 2018, partially offset by the recognition of license and contract revenue of $60.3 million for the year ended June 30, 2019, compared to $67.1 million of license and contract revenue for the year ended June 30, 2018.

    Revenue
    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.

    For the quarter and year ended June 30, 2018, Palatin recognized $20.6 million and $62.1 million, respectively, in license and contract revenue related to our license agreement with AMAG and an additional $5 million in license revenue for the year ended June 30, 2018 related to our license agreement with Fosun.

    Operating Expenses
    Total operating expenses for the quarter ended June 30, 2019 were $8.1 million, compared to $8.3 million for the comparable quarter of 2018.  For the year ended June 30, 2019, Palatin incurred $24.6 million of operating expenses, compared to $41.2 million for the year ended June 30, 2018.

    The decrease in operating expenses reflects the completion of the Vyleesi Phase 3 clinical trial program and ancillary studies necessary to file the NDA with the FDA in March 2018.

    Other Income/Expense
    Total other income, net, for the quarter and year ended June 30, 2019 was approximately $38,000 and $29,000, respectively.

    Total other expense, net, for the quarter and year ended June 30, 2018 was $0.2 million and $1.1 million, respectively.

    Total other income (expense), net consisted of investment income offset by interest expense related to venture debt.

    Income Tax
    Palatin recorded no income tax expense for the quarter and year ended June 30, 2019 as a result of the utilization of net operating losses.

    Income tax expense was $0.3 and $0.1 million, respectively, for the quarter and year ended June 30, 2018. Income tax expense for the year ended June 30, 2018 related to $0.6 million in tax withholding requirements related to our Fosun and Kwangdong license agreements that was recorded as an expense during the fiscal year ended June 30, 2018 offset by a tax benefit of $0.5 million related to the release of a valuation allowance against Palatin's federal alternative minimum tax credit as a result of the Tax Cuts and Jobs Act. 

    Cash Position
    Palatin's cash and cash equivalents were $43.5 million with accounts receivable of $60.3 million at June 30, 2019, compared to cash and cash equivalents and no accounts receivable of $38.0 million at June 30, 2018. Included in the accounts receivable balance at June 30, 2019 is a $60 million milestone payment due from AMAG for the Vyleesi FDA approval, which was received in July 2019. Current liabilities were $4.2 million as of June 30, 2019, compared to $10.8 million at June 30, 2018.

    Palatin Drug Discovery Programs
    During the conference call and webcast, management will update and discuss next steps in Palatin's portfolio of drug development programs.  These include Palatin's melanocortin MC1r agonist peptides for treatment of inflammatory indications and natriuretic peptide receptor agonist compounds for treatment of cardiovascular and fibrotic diseases.

    Conference Call / Webcast
    Palatin will host a conference call and audio webcast on September 12, 2019 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 1-888-254-3590 (U.S./Canada) or 1-323-994-2093 (international), conference ID 1394071.  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 webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (U.S./Canada) or 1-719-457-0820 (international), passcode 1394071.  The webcast and telephone replay will be available through September 19, 2019.

    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 and market potential for product candidates, 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.

    Vyleesi™ is a 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)








    Year Ended June 30,


    2019


    2018


    2017







    REVENUES






    License and contract

    $     60,300,476


    $       67,134,758


    $      44,723,827







    OPERATING EXPENSES






    Research and development

    14,857,095


    32,566,217


    45,683,174

    General and administrative

    9,699,061


    8,641,976


    9,610,147

    Total operating expenses

    24,556,156


    41,208,193


    55,293,321







    Income (loss) from operations

    35,744,320


    25,926,565


    (10,569,494)







    OTHER INCOME (EXPENSE)






    Investment income

    446,268


    310,663


    26,270

    Interest expense

    (417,561)


    (1,452,014)


    (2,288,309)

    Total other income (expense), net

    28,707


    (1,141,351)


    (2,262,039)







    Income (loss) before income taxes

    35,773,027


    24,785,214


    (12,831,533)

    Income tax expense

    -


    (82,500)


    (500,000)







    NET INCOME (LOSS)

    $     35,773,027


    $       24,702,714


    $     (13,331,533)







    Basic net income (loss) per common share

    $                0.17


    $                  0.12


    $                (0.07)







    Diluted net income (loss) income per common share

    $                0.16


    $                  0.12


    $                (0.07)







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

    207,670,607


    198,101,060


    184,087,719







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

    217,133,374


    207,007,558


    184,087,719







     

    PALATIN TECHNOLOGIES, INC.

    and Subsidiary

    Consolidated Balance Sheets

    (unaudited)






    June 30, 2019


    June 30, 2018

    ASSETS




    Current assets:




    Cash and cash equivalents

    $    43,510,422


    $    38,000,171

    Accounts receivable

    60,265,970


    -

    Prepaid expenses and other current assets

    637,289


    513,688

    Total current assets

    104,413,681


    38,513,859





    Property and equipment, net

    141,539


    164,035

    Other assets

    179,916


    338,916

    Total assets

    $  104,735,136


    $    39,016,810





    LIABILITIES AND STOCKHOLDERS' EQUITY 




    Current liabilities:




    Accounts payable 

    $         504,787


    $      2,223,693

    Accrued expenses

    2,848,692


    2,103,021

    Notes payable, net of discount

    332,896


    5,948,763

    Other current liabilities

    499,517


    487,488

    Total current liabilities

    4,185,892


    10,762,965





    Notes payable, net of discount

    -


    332,898

    Deferred revenue

    -


    500,000

    Other non-current liabilities

    -


    456,038

    Total liabilities

    4,185,892


    12,051,901





    Stockholders' equity:




    Preferred stock of $0.01 par value – authorized 10,000,000 shares; shares
    issued and outstanding designated as follows:




    Series A Convertible: authorized 264,000 shares: issued and outstanding
    4,030 shares as of June 30, 2019 and June 30, 2018

    40


    40

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




    issued and outstanding 226,815,363 shares as of June 30, 2019 and
    200,554,205 shares as of June 30, 2018

    2,268,154


    2,005,542

    Additional paid-in capital

    394,053,929


    357,005,233

    Accumulated deficit 

    (295,772,879)


    (332,045,906)

    Total stockholders' equity 

    100,549,244


    26,964,909

    Total liabilities and stockholders' equity

    $  104,735,136


    $    39,016,810





               

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/palatin-technologies-inc-reports-fourth-quarter-and-fiscal-year-2019-results-300916587.html

    SOURCE Palatin Technologies, Inc.

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  27. CRANBURY, N.J., Sept. 11, 2019 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN) will announce its fourth quarter and fiscal year end 2019 operating results on Thursday, September 12, 2019 before the open of the U.S. financial markets.

    Palatin Technologies, Inc.

    Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on September 12, 2019 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 2019 Financial Results Press Release       

    9/12/2019 at 7:30 a.m. ET



    Q4 and Fiscal Year End 2019 Conference Call-Live                 

    CRANBURY, N.J., Sept. 11, 2019 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE:PTN) will announce its fourth quarter and fiscal year end 2019 operating results on Thursday, September 12, 2019 before the open of the U.S. financial markets.

    Palatin Technologies, Inc.

    Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on September 12, 2019 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 2019 Financial Results Press Release       

    9/12/2019 at 7:30 a.m. ET



    Q4 and Fiscal Year End 2019 Conference Call-Live                       

    9/12/2019 at 11:00 a.m. ET

    US/Canada Dial-In Number:                                                           

    1-888-254-3590

    International Dial-In Number:                                                        

    1-323-994-2093

    Conference ID:                                                                                

    1394071



    Q4 and Fiscal Year End 2019 Conference Call-Replay                   

    9/12/2019-9/19/2019

    US/Canada Dial-In Number:                                                           

    1-888-203-1112

    International Dial-In Number:                                                        

    1-719-457-0820

    Replay Passcode:                                                                            

    1394071



    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--fiscal-year-end-2019-results-teleconference-and-webcast-to-be-held-on-september-12-2019-300916275.html

    SOURCE Palatin Technologies, Inc.

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