Processa Pharmaceuticals

Processa Pharmaceuticals, Inc. engages in the discovery, development, and commercialization of drug products for the treatment of serious medical conditions. Its main product candidate is PCS499, which is intended for the treatment of Necrobiosis Lipoidica. The company was founded by David Young, Patrick Lin, Sian E. Bigora, Wendy Guy, and Chang Rung Chen on March 29, 2011 and is headquartered in Hanover, MD.

Earnings data Q1 2021

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Earnings data Q2 2022

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Earnings data Q2 2023

Earnings data Q3 2023

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Earnings data Q2 2024

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Next Generation Capecitabine (NGC) D osage R egimens H ave B een I dentified I n T he O ngoing Phase 1B T rial W ith P otentially B etter S afety A nd E fficacy P rofiles T han E xisting C hemotherapy

Processa Successfully Identifies Next Generation Capecitabine Dosage Regimens for Phase 2B Trial

HANOVER, MD, Sept. 15, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), (“Processa” or “Company”), a clinical stage biopharmaceutical company focused on developing products to improve survival and/or quality of life for patients who have an unmet medical need condition for which there are few or no therapeutic options, today provided an update on enrollment across all its clinical programs.

Processa Pharmaceuticals Provides Update on Enrollment Across all Clinical Programs

HANOVER, MD, Sept. 07, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have an unmet medical need condition today announced that Dr. Dr. David Young, Chief Executive Officer, will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Wednesday, September 14, 2022.

Processa Pharmaceuticals to Present at H.C. Wainwright 22nd Annual Global Investment Conference on September 12-14, 2022

Board A ppointments Designed to Position Company for Anticipated Milestones While Ensuring Adherence to the Highest Governance Standards

Processa Pharmaceuticals Appoints Khoso Baluch and James Neal to its Board of Directors and Justin Yorke to Chairman of the Board

Processa Pharmaceuticals, Inc. (NASDAQ:PCSA ) Q2 2022 Earnings Conference Call August 11, 2022 4:30 PM ET Company Participants James Stanker - Chief Financial Officer David Young - President and Chief Executive Officer Conference Call Participants François Brisebois - Oppenheimer & Co. Inc. Naz Rahman - Maxim Group LLC Operator Good afternoon, ladies and gentlemen, and welcome to the Processa Pharmaceuticals Second Quarter 2022 Earnings Call. At this time, all participants have been placed on a listen-only mode, and we will open the floor for your questions and comments after the presentation.

Processa Pharmaceuticals, Inc. (PCSA) CEO David Young on Q2 2022 Results - Earnings Call Transcript

HANOVER, Md., Aug. 12, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a clinical stage company developing drugs for patients who have unmet medical conditions and/or require better treatment options to improve a patient's survival and/or quality of life, today announced financial results for the quarter ended June 30, 2022, and provided an update on its clinical programs.

Processa Pharmaceuticals Announces Second Quarter 2022 Financial Results and Provides Corporate Update

HANOVER, MD, Aug. 05, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have an unmet medical need condition announces today it will host a conference call and live webcast on August 11, 2022, at 4:30 p.m. EST to discuss its second quarter 2022 results and provide an update on its clinical pipeline.

Processa Pharmaceuticals to Host Conference Call to Discuss Its Second Quarter 2022 Results and Provide 2nd Half Clinical Pipeline Update on August 11, 2022, at 4:30 p.m. EST

HANOVER, MD, Aug. 04, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), (“Processa” or the “Company”), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have unmet medical need conditions, announces today that it has launched a new website Necrobiosislipoidicastudy.com. The website is designed to increase awareness of ulcerative Necrobiosis Lipoidica (“uNL”), an extremely rare condition, and to inform patients about the ongoing Phase 2 study that is investigating the use of PCS499 for the treatment of this rare condition.

Processa Pharmaceuticals Announces Launch of Website to Increase Awareness of Ulcerative Necrobiosis Lipoidica and to Inform Patients of the ongoing Phase 2B Study of PCS499

HANOVER, MD, Aug. 03, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), (“Processa” or the “Company”), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have unmet medical need conditions, announces today that it has launched a new website Necrobiosislipoidicastudy.com. The website is designed to increase awareness of ulcerative Necrobiosis Lipoidica (“uNL”), an extremely rare condition, and to inform patients about the ongoing Phase 2 study that is investigating the use of PCS499 for the treatment of this rare condition.

Processa Pharmaceuticals Announces Launch of Website (www.Necrobiosislipoidicastudy.com) to Increase Awareness of Ulcerative Necrobiosis Lipoidica and to Inform Patients of the ongoing Phase 2B Study of PCS499

HANOVER, MD., July 12, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a clinical stage biopharmaceutical company developing drugs to improve the survival and/or quality of life for patients who have unmet medical conditions announced today that Dr. David Young, it's Chief Executive Officer, will present “Thinking Regulatory First - Considerations for the Effective Development of Rare Disease Therapies” at the World Orphan Drug Congress USA 2022 Conference on Wednesday, July 13, 2022 at 3:25 pm EDT.

Processa Pharmaceuticals to Present at the World Orphan Drug Congress USA, July 11-13, 2022

Processa Pharmaceuticals, Inc. (NASDAQ:PCSA ) Q1 2022 Earnings Conference Call May 12, 2022 4:30 PM ET Company Participants Jim Stanker – Chief Financial Officer David Young – Chief Executive Officer Conference Call Participants Robin Garner – Craig-Hallum Naz Rahman – Maxim Group Operator Greetings, and welcome to Processa Pharmaceuticals First Quarter 2022 Earnings Conference Call and Corporate Update. At this time, all participants are in a listen-only mode.

Processa Pharmaceuticals' (PCSA) CEO David Young on Q1 2022 Results - Earnings Call Transcript

HANOVER, Md., May 12, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a clinical stage company developing drugs for patients who have unmet medical conditions that require better treatment options to improve a patient's survival and/or quality of life, today announced financial results for the quarter ended March 31, 2022, and provided an update on its clinical programs.

Processa Pharmaceuticals Announces First Quarter 2022 Financial Results and Provides Corporate Update

Processa f ocuse s on i dentify ing the PCS6422 regimens to i ncrease c apecitabine potency while identifying the MTD of Next Generation Capecitabine

Processa Pharmaceuticals Doses First Patient in Amended Phase 1B Protocol for PCS6422 Combined with Capecitabine (Next Generation Capecitabine)

HANOVER, MD, April 05, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), (“Processa” or the “Company”), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have an unmet medical need, announced today that it has enrolled its first patient in the Phase 2A clinical trial of PCS12852 in patients with moderate to severe gastroparesis. Gastroparesis is a chronic gastric motility disorder in which the stomach does not empty food as quickly as it should, resulting in potentially serious forms of heartburn, nausea, vomiting, and bloating for millions of patients in the U.S. As such gastroparesis is recognized to be a serious unmet medical need condition for which patients need alternative treatment options.

Processa Pharmaceuticals Announces First Patient Enrolled in the PCS12852 Phase 2A Trial for the Treatment of Gastroparesis

Processa Pharmaceuticals' (PCSA) CEO David Young on Q4 2021 Results - Earnings Call Transcript

Processa Pharmaceuticals Announces Year-End 2021 Results and Provides Corporate Update

HANOVER, MD, March 23, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have an unmet medical need condition announces today it will host a conference call and live webcast on March 30, 2022, at 4:30 p.m. EST to discuss its fourth quarter 2021 results and provide an update on its clinical pipeline.

Processa Pharmaceuticals To Host Conference Call to Discuss Fourth Quarter 2021 Results and Provide Drug Development Update on March 30 at 4:30 p.m. EST

HANOVER, MD, March 10, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), (“Processa” or the “Company”), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have unmet medical need conditions, announced today that the Company's CEO Dr. David Young, will present at the Oppenheimer 32nd Annual Healthcare Conference on March 17th, 2022 at 10:00 AM Eastern.

Processa Pharmaceuticals CEO Dr. David Young To Present at the Oppenheimer 32nd Annual Healthcare Conference

HANOVER, MD., Jan. 26, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical stage company developing drugs for patients who have unmet medical conditions that require better treatment options to improve a patient's survival and/or quality of life, today released the following letter to shareholders from its Chief Executive Officer Dr. David Young.

Processa Pharmaceuticals CEO Dr. David Young Issues Letter to Shareholders Providing Outlook for 2022

Processa Pharmaceuticals' (PCSA) CEO David Young on Q3 2021 Results - Earnings Call Transcript

Clinical D rug P ipeline is F unded and T argeting M ajor M ilestones mid-2022

Processa Pharmaceuticals Announces Third Quarter 2021 Results and Provides Corporate Update

HANOVER, MD, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), (“Processa” or the “Company”), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have unmet medical need conditions, announced today that the Company's Next Generation Capecitabine dosage regimen (a combination of PCS6422 administered with capecitabine) successfully inhibited dihydropyrimidine dehydrogenase (DPD), altering the metabolism of 5-fluoruracil (5-FU) at least during the first 24-48 hours after PCS6422 administration but not throughout the 7 days of capecitabine dosing. If Next Generation Capecitabine inhibits the metabolism of 5-FU throughout capecitabine dosing, the combination product could be a more potent and safer cancer treatment than current chemotherapy drugs including FDA approved capecitabine, opening a multi-billion-dollar cancer chemotherapy market across multiple types of cancer.

Processa Pharmaceuticals Announces Next Generation Capecitabine (Combination of PCS6422 and Capecitabine) Inhibits DPD in Phase 1b Interim Analysis

HANOVER, MD, Oct. 26, 2021 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), (“Processa” or the “Company”), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have unmet medical needs, today announced that the Company will report financial results for the quarter ended September 30, 2021 on Thursday November 11, 2021.

Processa Pharmaceuticals Schedules Conference Call to Discuss Third Quarter Results and Provide Drug Development Update on November 11 at 5:30 p.m. EST

HANOVER, MD, Oct. 12, 2021 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), (“Processa” or the “Company”), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have unmet medical needs, announced today that they have been cleared by the U.S. Food and Drug Administration (FDA) to proceed with a Phase 2a clinical trial of PCS12852 in patients with moderate to severe gastroparesis, an unmet medical need condition for which patients need alternative, safer treatment options.

Processa Pharmaceuticals Cleared by FDA to Proceed with Phase 2a Trial for the Treatment of Gastroparesis

HANOVER, MD, Sept. 16, 2021 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), (“Processa” or the “Company”), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have unmet medical needs, announced today that management will participate in upcoming investor conferences:

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