PTN Palatin Technologies Inc.

0.66
+0.01  (+1%)
Previous Close 0.65
Open 0.65
52 Week Low 0.375
52 Week High 1.3
Market Cap $151,132,540
Shares 230,034,307
Float 226,797,583
Enterprise Value $78,556,204
Volume 1,050,551
Av. Daily Volume 5,244,236
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Upcoming Catalysts

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

Drug Stage Notes
PL-8177
Non-infectious uveitis
Phase 2
Phase 2
Phase 2 trial planned for 2H 2021.
PL9643
Dry eye disease (DED)
Phase 2/3
Phase 2/3
Phase 2/3 trial planned of mid-2021.
PL-3994
Heart failure
Phase 2a
Phase 2a
Phase 2 dosing commenced November 2020.
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
Approved
Approved
FDA approval announced June 21, 2019.

Latest News

  1. CRANBURY, N.J., March 5, 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 that Carl Spana, Ph.D., President and Chief Executive Officer, will participate in the H.C. Wainwright Global Life Sciences Virtual Conference on March 9-10, 2021. The company's presentation will be available for on-demand viewing beginning on Tuesday, March 9, 2021 at 7:00 a.m. ET and will remain available on the Investors page under Webcasts of Palatin's website: www.Palatin.com for approximately 30 days following the presentation.

    CRANBURY, N.J., March 5, 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 that Carl Spana, Ph.D., President and Chief Executive Officer, will participate in the H.C. Wainwright Global Life Sciences Virtual Conference on March 9-10, 2021. The company's presentation will be available for on-demand viewing beginning on Tuesday, March 9, 2021 at 7:00 a.m. ET and will remain available on the Investors page under Webcasts of Palatin's website: www.Palatin.com for approximately 30 days following the presentation.

    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, 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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  2. 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









     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/palatin-technologies-inc-reports-second-quarter-fiscal-year-2021-financial-results-and-recent-business-highlights-301229666.html

    SOURCE Palatin Technologies, Inc.

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  3. 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.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/palatin-technologies-inc-to-report-second-quarter-fiscal-year-2021-results-teleconference-and-webcast-to-be-held-on-february-17-2021-301227418.html

    SOURCE Palatin Technologies, Inc.

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  4. 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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  5. 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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    SOURCE Palatin Technologies, Inc.

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