HANOVER, Md., June 13, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage pharmaceutical company developing Next Generation Cancer (NGC) therapies, today announced that members of its executive leadership team will attend and participate in the 2025 BIO International Convention, taking place June 16-19, 2025, in Boston, Massachusetts. During the conference, Processa’s CEO, Georg Ng and Dr. David Young, President R&D will conduct one-on-one meetings with potential partne ...

HANOVER, Md., May 30, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage pharmaceutical company focused on developing the next generation cancer therapies with improved efficacy and safety, today announced the acceptance of three abstracts for the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 to June 3, 2025, at McCormick Place in Chicago, Illinois. The abstracts highlight Processa’s pipeline of Next Generation Cancer (NGC) drug c ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number 001-39531 Processa Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 45-1539785 (State ...

About Processa Pharmaceuticals, Inc. Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa's NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its ...

Core Insights - Processa Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing next-generation cancer therapies with enhanced efficacy and safety [1][5] - Dr. David Young, the Founder and President of Research & Development, will present at the World Orphan Drug Congress USA 2025, discussing FDA's Project Optimus principles [2][3] Company Overview - Processa's strategy involves modifying existing FDA-approved oncology therapies to improve their metabolism and distribution while retaining their cancer-killing mechanisms [5] - The company aims to develop more effective therapy options with better tolerability for cancer patients through an efficient regulatory path [5] Presentation Details - Dr. Young's presentation is titled "Applying Principles of FDA's Project Optimus to Oncology and Non-Oncology Rare Diseases" and is scheduled for April 24, 2025 [2][3] - The presentation will focus on optimizing drug dosing to enhance the balance of efficacy and safety for rare oncology and non-oncology diseases [3]

Financial Performance - The company reported an operating loss of $12.1 million for the year ended December 31, 2024, compared to an operating loss of $11.5 million in 2023, reflecting an increase in research and development costs [343]. - The company had no revenue during the years ended December 31, 2024 and 2023, with no immediate sales prospects [344]. - The company has an accumulated deficit of approximately $87.2 million as of December 31, 2024, with a net loss of approximately $11.9 million for the year [355]. Research and Development - Research and development expenses increased by approximately $1.5 million to $7.3 million in 2024, primarily due to ongoing testing and related expenses for the Phase 1B trial for NGC-Cap [346]. - The company is focused on developing drugs that improve patient survival and quality of life while providing a more efficient path to FDA approval [335]. - The company is exploring options for PCS12852, a potential treatment for diabetic gastroparesis, which has a global prevalence of over 30 million [338]. - The company has recorded $1.3 million in prepaid expenses for advanced payments made to CROs and other vendors for the NGC-Cap Phase 2 clinical trial [350]. Cash Flow and Financing - Net cash used in operating activities increased to $11,245,042 in 2024 from $8,063,346 in 2023, primarily due to higher costs associated with clinical trials and payroll expenses [361]. - Net cash provided by financing activities amounted to $7,733,414 in 2024, up from $6,268,724 in 2023, driven by the sale of common stock and warrants [359]. - The company raised gross proceeds of $5.0 million from a public offering on January 27, 2025, with net proceeds of $4.5 million intended for research and development and general corporate purposes [340]. - The company raised net proceeds of $6.3 million from a public offering in 2024, selling 476,000 shares of common stock [364]. - The company plans to continue pursuing financing alternatives to support its clinical trials and operational plans, with no assurance of obtaining necessary funding in the future [355]. - The company has an effective shelf registration statement on file with the SEC, allowing for potential future capital raises [358]. Expenses and Obligations - General and administrative expenses decreased by approximately $875,000 to $4.8 million in 2024, mainly due to a reduction in professional fees [351]. - Total contractual obligations at December 31, 2024, were $77,432, primarily related to operating lease obligations [365]. - As of December 31, 2024, the company had prepaid expenses of approximately $1.8 million related to advanced payments for clinical trials [362]. Future Outlook - The company anticipates ongoing negative cash flows from operating activities as it continues its Phase 2 trial for NGC-Cap and evaluates other drugs in its portfolio [361]. - The increase in cash used in operating activities was attributed to costs related to closing Phase 1B and commencing Phase 2 trials for NGC-Cap [361]. - The company has not recorded any unrecognized tax benefits as of December 31, 2024, and does not expect significant changes in the next twelve months [379].

Core Viewpoint - Processa Pharmaceuticals, Inc. is participating in the MedInvest Biotech and Pharma Investor Conference, highlighting its focus on developing next-generation cancer therapies with improved efficacy and safety [1][2]. Company Overview - Processa is a clinical-stage pharmaceutical company dedicated to developing Next Generation Cancer (NGC) drugs that modify existing FDA-approved oncology therapies to enhance their metabolism and distribution while preserving their cancer-killing mechanisms [3]. - The company's strategy combines a novel oncology pipeline with proven active molecules and a Regulatory Science Approach to create more effective and tolerable therapy options for cancer patients [3]. Conference Participation - Management will present a corporate overview on March 28, 2025, at 9:40 a.m. Eastern time, and will engage in one-on-one meetings with registered investors throughout the conference [2]. - The presentation will be accessible on Processa's website, indicating a commitment to transparency and investor engagement [2].

Core Points - Processa Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing next-generation cancer therapies with improved efficacy and safety [1][3] - The company will participate in the 2025 BIO CEO & Investor Conference on February 10-11, 2025, at the New York Marriott Marquis [1] - Management will present a corporate overview on February 11 at 10:00 a.m. Eastern time and will hold one-on-one meetings with registered investors throughout the conference [2] Company Overview - Processa's strategy involves modifying existing FDA-approved oncology therapies to enhance their metabolism and distribution while maintaining their cancer-killing mechanisms [3] - The company aims to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path [3]

Core Viewpoint - Processa Pharmaceuticals, Inc. is participating in the 2025 BIO CEO & Investor Conference, highlighting its focus on developing next-generation cancer therapies with improved efficacy and safety [1][2]. Company Overview - Processa is a clinical-stage pharmaceutical company dedicated to developing Next Generation Cancer (NGC) drugs that modify existing FDA-approved oncology therapies to enhance their metabolism and distribution while preserving their cancer-killing mechanisms [3]. - The company's strategy combines a novel oncology pipeline with proven active molecules and a Regulatory Science Approach to create more effective and tolerable therapy options for cancer patients [3]. Conference Participation - Management will present a corporate overview on February 11, 2025, at 10:00 a.m. Eastern time and will engage in one-on-one meetings with registered investors throughout the conference [2].

Core Viewpoint - Processa Pharmaceuticals, Inc. has successfully closed a public offering, raising $5 million to support its development of next-generation chemotherapeutic drugs with enhanced efficacy and safety [1][2]. Group 1: Offering Details - The public offering consisted of 8,050,672 shares of common stock and accompanying Series A and Series B warrants, with a combined purchase price of $0.615 for institutional investors and $0.7975 for the CEO and certain board members [1]. - The gross proceeds from the offering, before deducting fees and expenses, were $5 million, excluding potential proceeds from the exercise of the warrants [2]. Group 2: Regulatory Information - A registration statement on Form S-1 was declared effective by the SEC on January 27, 2025, and the offering was made only by means of a prospectus [3]. Group 3: Company Overview - Processa Pharmaceuticals is focused on developing Next Generation Chemotherapy (NGC) drugs that modify existing FDA-approved oncology therapies to improve safety and efficacy while maintaining their cancer-killing mechanisms [5].