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 [1][2] - The presentation will discuss the application of FDA's Project Optimus principles to improve drug approval processes for rare oncology and non-oncology diseases [3] Company Overview - Processa's strategy involves modifying existing FDA-approved oncology therapies to enhance their metabolism and distribution while preserving their cancer-killing mechanisms [5] - The company aims to develop more effective therapy options with improved tolerability for cancer patients through a regulatory science approach [5] Event Details - Dr. Young's presentation is scheduled for April 24, 2025, at 2:00 p.m. Eastern Time at the Boston Convention & Exhibition Center [2] - The focus of the presentation will be on optimizing dose determination to balance efficacy and safety in drug development [3]

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].

Core Viewpoint - Processa Pharmaceuticals, Inc. has announced a public offering aimed at raising funds to support its development of next-generation chemotherapeutic drugs with enhanced efficacy and safety [1][8]. Group 1: Offering Details - The public offering consists 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 are expected to be $5 million, excluding any proceeds from the exercise of the Series A and Series B warrants [3]. - The offering is anticipated to close on or about January 29, 2025, pending customary closing conditions [3]. Group 2: Warrants Information - Series A warrants will have an exercise price of $0.65 per share, exercisable upon stockholder approval and expiring five years from that date [2]. - Series B warrants will also have an exercise price of $0.65 per share, exercisable upon stockholder approval and expiring eighteen months from that date [2]. - The company plans to seek stockholder approval for the issuance of shares upon the exercise of these warrants within 90 days after the offering [4]. 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 [8]. - The company's strategy involves combining its oncology pipeline with proven cancer-killing molecules to create more effective therapy options for cancer patients [8].

Core Insights - Processa Pharmaceuticals, Inc. is actively participating in multiple investor and industry conferences in September 2024, including the H.C. Wainwright 26th Annual Global Investment Conference and the European Society for Medical Oncology (ESMO) Congress 2024 [1][2] Group 1: Conference Participation - Management will hold one-on-one meetings with investors and deliver a company presentation at the H.C. Wainwright conference from September 9-11, 2024 [1] - A recorded presentation will be available on demand starting September 9th at 7:00 am Eastern time on the company's website [1] - At the ESMO Congress from September 13-17, 2024, management will engage with clinicians, researchers, industry key opinion leaders, and potential partners [1] Group 2: Company Overview - Processa is a clinical-stage pharmaceutical company focused on developing Next Generation Chemotherapy (NGC) drugs that offer improved safety and efficacy [2] - The NGC drugs are modifications of existing FDA-approved oncology therapies, altering their metabolism and/or distribution while preserving their cancer-killing mechanisms [2] - The company's strategy combines a novel oncology pipeline with proven active molecules and a Regulatory Science Approach to create more effective therapy options with better tolerability for cancer patients [2]

Financial Performance - For the three months ended June 30, 2024, the company reported a net loss of $3,010,326, compared to a net loss of $2,612,565 in the same period of 2023[67]. - Research and development expenses for the six months ended June 30, 2024, totaled $3,269,555, a decrease of $72,954 from $3,342,509 in 2023[67]. - General and administrative expenses decreased by approximately $855,000 to $2.6 million for the six months ended June 30, 2024, compared to $3.5 million in 2023[75]. - The company used net cash of $5,394,713 in operating activities during the six months ended June 30, 2024, up from $4,178,539 in 2023[76]. - The company had cash and cash equivalents of $5.6 million as of June 30, 2024, which is expected to meet operating needs into late 2024[81]. - The accumulated deficit reached $81.1 million as of June 30, 2024, with no product revenue generated to date[82]. - The company raised net proceeds of $6.3 million from the sale of common stock and warrants during the six months ended June 30, 2024[83]. Stock and Financing Activities - The company raised gross proceeds of $7.0 million (net proceeds of $6.3 million) from the sale of 476,000 shares in a public offering on January 30, 2024[64]. - The company filed a registration statement for an ATM offering of up to $50 million, with an initial offering price of $2.4 million[65]. - The company filed a registration statement with the SEC for an offering of up to $50 million in securities, including an "at the market offering" of common stock with an aggregate offering price of up to $2.4 million[84]. - Future funding plans include public or private equity offerings, debt financings, and strategic alliances, but the company may delay or suspend clinical trials if adequate financing is not obtained[85]. Corporate Governance - Russell Skibsted was appointed as CFO with an annual salary of $400,000 and a potential bonus of 35% of his base compensation[66]. Clinical Development - The company is advancing its pipeline of Next Generation Chemotherapy (NGC) drugs, including NGC-Cap, NGC-Gem, and NGC-Iri, which aim to improve safety and efficacy profiles compared to existing therapies[50]. - NGC-Cap has demonstrated up to 50 times greater potency than capecitabine alone in a Phase 1B trial, indicating a potentially improved safety-efficacy profile[54]. - The Phase 2 trial for NGC-Cap is set to initiate, comparing its safety-efficacy profile against FDA-approved capecitabine in approximately 60 to 90 patients with advanced or metastatic breast cancer[57]. - The company plans to meet with the FDA to discuss trial designs for NGC-Gem, which is expected to offer benefits for patients resistant to gemcitabine[58]. - The company terminated the Phase 2 trial for PCS499 due to challenges in patient enrollment but completed a Phase 2A trial for PCS12852 with positive results[63]. - The company is committed to meeting specific diligence milestones for its licensing agreements, including dosing the first patient in a Phase 2 or 3 clinical trial for NGC-Cap by October 2, 2024[57]. - The company anticipates increased research and development costs as it begins its Phase 2 clinical trial for NGC-Cap in breast cancer[77]. Strategic Focus - The company is exploring options to monetize non-core drug assets, including out-licensing or partnering opportunities[63]. - The company’s strategic focus is on utilizing its Regulatory Science Approach to enhance the development of oncology drugs, aiming for greater efficiencies and improved chances of FDA approval[49]. Accounting and Reporting - The company’s financial statements are prepared in accordance with U.S. GAAP, requiring estimates and judgments that may affect reported amounts of assets and liabilities[87]. - There have been no changes in critical accounting policies from the most recent Annual Report on Form 10-K, and actual results may differ from estimates used[88]. - Recently issued accounting pronouncements have been evaluated, showing no material impact on the company's financial position or results of operations[89]. - As of June 30, 2024, there were no off-balance sheet arrangements reported by the company[86].