|Over a week ago|
Palatin: Phase 2 PL9643 study data expected in calendar Q4 07:3309/2809/28/20
Palatin reports Q4 EPS (3c), consensus (2c) » 07:3209/2809/28/20
Palatin recognized no…
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 its license agreement with AMAG. Palatin's cash and cash equivalents were $82.9M with no accounts receivable as of June 30, 2020, compared to cash and cash equivalents of $43.5M with accounts receivable of $60.3M 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.
|Over a month ago|
Palatin completes enrollment in Phase 2 Study with PL9643 » 07:3608/0508/05/20
Palatin Technologies announced completion of enrollment of its Phase 2 study with PL9643 for the treatment of dry eye disease. 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.
Agreement termination 'optimal' for Vyleesi future, says H.C. Wainwright » 10:1607/2707/27/20
PTN, AMAG, PFE, ABBV, MRK
H.C. Wainwright analyst…
H.C. Wainwright analyst Joseph Pantginis notes that Palatin (PTN) and Amag Pharmaceuticals (AMAG) announced the mutual termination of the license agreement for Vyleesi in North America, with Palatin retaining all North American and development and commercialization rights. The analyst believes that a major point for investors to focus on is that Amag's launch of the drug was essentially aborted because of its change of strategy before a market for Vyleesi could be established. The launch was still in the early stages of broad sampling. Instead of Amag licensing Vyleesi to someone else, Pantginis believes this is the optimal next step for the drug's future, as it gives Palatin important freedom to operate now, including finding the best potential partnership possible. Management indicated that all options are now on the table, which could range from North America again to broader geographic deals, he adds. Pantginis believes that Pfizer (PFE), AbbVie (ABBV), and Merck (MRK) could be relevant targets for partnering. Further, it would be surprising to him if Palatin had not already begun discussions with these companies prior to partnering with Amag. He has a Buy rating and a price target of $2 on Palatin's shares.
Palatin and AMAG terminate license agreement for Vyleesi » 07:0207/2707/27/20
Palatin Technologies announced that it has mutually terminated the January 2017 license agreement which granted AMAG Pharmaceuticals exclusive North American rights to market Vyleesi, 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 $12M payment to Palatin at closing and a $4.3M 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.
|Over a quarter ago|
Palatin reinitiates enrollment of Phase 2 study with PL9643 for dry eye disease » 07:3207/0807/08/20
Palatin Technologies reinitiated enrollment of its Phase 2 study with PL9643 for the treatment of dry eye disease, or DED. After pausing patient recruitment 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 Q4. This Phase 2 study is a multi-center, randomized double-masked, placebo-controlled study evaluating the safety and efficacy of PL9643 ophthalmic solution 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.
Palatin to develop PL8177 as a treatment for COVID-19 patients » 07:3306/2306/23/20
Palatin Technologies 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. 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 on this program, received technical and strategic advice, and submitted a pre-Investigational New Drug package to the Division of Pulmonary, Allergy, and Critical Care of the U.S. 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.
Palatin reports Q3 EPS (2c), consensus (2c) » 07:3205/1205/12/20
Reports Q3 revenue $0,…
Reports Q3 revenue $0, consensus $50,000. Reports cash and cash equivalents $88.9M as of March 31 compared to $91.5M at December 31, 2019, and cash, cash equivalents and accounts receivable of $103.8M at June 30, 2019. "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. "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."
Palatin provides operational update » 07:3704/3004/30/20
Palatin provided an…
Palatin provided an update on business operations as a result of the global COVID-19 pandemic. Assuming partial opening of economic activities by mid-2020, senior management believes there will be limited impact of the pandemic on operations. A Phase 2 clinical study with PL9643 for dry eye disease started in January. Palatin anticipates restarting enrollment in June. Data readout remains on track for Q4, no delay 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, a two quarter delay. 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. Anticipates filing an IND and commencing clinical trials with PL8177 for non-infectious uveitis in the second-half of calendar year 2021, a one quarter delay. 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. PL3994, an NPR-A agonist, will be evaluated in a Phase 2a clinical study in heart failure patients with preserved ejection fraction. The study is now anticipated to start patient enrollment in the second half of calendar year 2020, a one quarter delay. Palatin's cash and cash equivalents of $88.9M as of March 31 represents cash runway of at least two years based on projected operations.
Palatin enrolls first patient in dry eye disease Phase 2 clinical trial » 07:3202/1902/19/20
Palatin has enrolled the…
Palatin has enrolled the first patient in a Phase 2 clinical trial of topical PL9643, a melanocortin 1/5 receptor agonist, for the treatment of dry eye disease. The company expects to report data from this study in Q4. The Phase 2 study is a multi-center, randomized double-masked and placebo-controlled study evaluating the efficacy and safety of PL9643 ophthalmic solution 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. The two primary endpoints are inferior corneal fluorescein staining and ocular discomfort. There are several secondary and exploratory outcome measures as well.