Core Viewpoint - Processa Pharmaceuticals has entered into a binding term sheet with Intact Therapeutics for the exclusive option to license PCS12852, a 5-HT4 receptor agonist aimed at treating gastroparesis and other gastrointestinal motility disorders [1][3]. Financial Terms - Processa is set to receive a $2.5 million option exercise fee, up to $20 million in development and regulatory milestone payments, and over $432.5 million in commercial milestone payments based on net product sales [2][8]. - Intact will pay Processa a double-digit royalty on worldwide net sales of licensed products, excluding South Korea, and provide an equity stake of 3.5% in Intact upon closing [2][8]. Clinical Significance - PCS12852 has shown a favorable safety and efficacy profile in clinical studies, particularly in a Phase 2a trial for diabetic gastroparesis, a condition with limited treatment options [3][4]. - The drug is designed to restore normal gastric emptying without the cardiovascular and central nervous system side effects associated with older agents in this class [3]. Strategic Partnership - The partnership is expected to unlock the value of Processa's non-oncology assets while focusing on developing next-generation cancer therapies [3]. - Intact Therapeutics aims to address significant unmet clinical needs in gastrointestinal diseases, enhancing patient quality of life through innovative therapies [3][5]. Company Background - Intact Therapeutics is a clinical-stage biopharmaceutical company focused on next-generation therapies for gastrointestinal diseases, leveraging proprietary thermal hydrogel technology [5]. - Processa Pharmaceuticals specializes in developing next-generation cancer drugs with improved safety and efficacy, modifying existing FDA-approved oncology therapies [7].

Core Insights - Processa Pharmaceuticals, Inc. is participating in the 2025 BIO International Convention to showcase its Next Generation Cancer (NGC) therapies [1][4] - The company will provide updates on its strategic direction and clinical progress, particularly focusing on its lead asset NGC-Cap, which is in a Phase 2 trial for metastatic breast cancer [2][3] - The CEO emphasized the opportunity to engage with potential partners committed to developing safer and more effective cancer treatments [3] Company Overview - Processa Pharmaceuticals is a clinical-stage pharmaceutical company focused on developing NGC drugs that enhance safety and efficacy [5] - The NGC drugs are modifications of existing FDA-approved oncology therapies, aiming to alter metabolism and distribution while maintaining cancer cell-killing mechanisms [5] - The company's strategy combines a novel oncology pipeline with proven active molecules and a Regulatory Science Approach to improve therapy options for cancer patients [5]

Core Insights - Processa Pharmaceuticals, Inc. announced the acceptance of three abstracts for the 2025 ASCO Annual Meeting, showcasing its Next Generation Cancer (NGC) drug candidates, including PCS6422 and PCS11T [1][6] Abstract Summaries - The first abstract discusses the safety and efficacy of Eniluracil + Capecitabine (6422 + Cap) in a Phase 1b trial, highlighting its improved safety profile and anti-tumor activity compared to standard capecitabine [3][4] - The second abstract outlines a Project Optimus-aligned approach for the preclinical study of PCS11T, a tumor-targeted pro-drug of SN-38, aimed at increasing drug concentration in tumors while minimizing systemic toxicity [4][5] - The third abstract presents an overview of an ongoing Phase 2 adaptive design trial evaluating the safety and efficacy of PCS6422 combined with capecitabine in patients with advanced or metastatic breast cancer, focusing on optimal dosing regimens and personalized medicine [9]

Part I. Financial Information [Financial Statements](index=3&type=section&id=Item%201%3A%20Financial%20Statements) Unaudited Q1 2025 financial statements show a **$2.83 million** net loss and increased assets, raising going concern doubts Condensed Consolidated Balance Sheets (unaudited) | | March 31, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,897,072 | $1,191,325 | | Total Current Assets | $3,757,886 | $1,873,619 | | Total Assets | $4,809,574 | $3,229,289 | | **Liabilities and Stockholders' Equity** | | | | Total Current Liabilities | $1,282,966 | $1,532,631 | | Total Liabilities | $1,282,966 | $1,533,118 | | Total Stockholders' Equity | $3,526,608 | $1,696,171 | | Total Liabilities and Stockholders' Equity | $4,809,574 | $3,229,289 | Condensed Consolidated Statements of Operations (unaudited) | | Three months ended March 31, 2025 ($) | Three months ended March 31, 2024 ($) | | :--- | :--- | :--- | | Research and development expenses | $1,588,540 | $1,539,070 | | General and administrative expenses | $1,258,450 | $1,270,528 | | Operating Loss | ($2,846,990) | ($2,809,598) | | Net Loss | ($2,834,405) | ($2,726,381) | | Net Loss Per Common Share - Basic and Diluted | ($0.30) | ($1.11) | Condensed Consolidated Statements of Cash Flows (unaudited) | | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | ($2,729,848) | ($2,048,884) | | Net cash provided by financing activities | $4,435,595 | $6,263,050 | | Net Increase (Decrease) in Cash | $1,705,747 | $4,214,166 | | Cash and Cash Equivalents - End of Period | $2,897,072 | $8,920,363 | - The company has incurred losses since inception, with an accumulated deficit of **$90.1 million** as of March 31, 2025. Management has expressed substantial doubt about the company's ability to continue as a going concern for one year, as current cash of **$2.9 million** is only expected to fund operations into mid-2025[22](index=22&type=chunk)[24](index=24&type=chunk)[27](index=27&type=chunk) - In January 2025, the company raised net proceeds of **$4.4 million** from a public offering of common stock and various warrants[23](index=23&type=chunk)[36](index=36&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=13&type=section&id=Item%202%3A%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Q1 2025 saw a net loss of **$2.8 million** and increased R&D expenses, with current cash only funding operations into mid-2025, necessitating additional financing - The company's strategy is to develop Next Generation Cancer (NGC) therapies by modifying existing, well-understood cancer drugs to improve their therapeutic effect and reduce toxicity. The pipeline includes NGC-Cap, NGC-Gem, and NGC-Iri[58](index=58&type=chunk)[59](index=59&type=chunk) Comparison of Operations for the three months ended March 31, | | 2025 ($) | 2024 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Research and development expenses | $1,588,540 | $1,539,070 | $49,470 | | General and administrative expenses | $1,258,450 | $1,270,528 | ($12,078) | | Net Loss | ($2,834,405) | ($2,726,381) | ($108,024) | - R&D expenses increased slightly due to higher preclinical and clinical trial costs for NGC-Cap's Phase 1B and Phase 2 trials, partially offset by a decrease in salaries from employee departures[67](index=67&type=chunk) - G&A expenses decreased slightly, primarily due to lower professional fees, offset by salary increases for C-suite executives and higher stock-based compensation expense[71](index=71&type=chunk) - The company's cash and cash equivalents of **$2.9 million** as of March 31, 2025, are projected to fund operations only into mid-2025, raising substantial doubt about its ability to continue as a going concern without securing additional funding[80](index=80&type=chunk)[81](index=81&type=chunk) - Net cash used in operating activities increased by approximately **$681,000** in Q1 2025 compared to Q1 2024, primarily due to increased clinical trial costs and a paydown of accounts payable[76](index=76&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=19&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is not applicable as the company qualifies as a smaller reporting company - As a smaller reporting company, this item is not applicable and has been omitted[91](index=91&type=chunk) [Controls and Procedures](index=19&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[92](index=92&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, the company's internal control[93](index=93&type=chunk) Part II. Other Information [Legal Procedures](index=19&type=section&id=Item%201.%20Legal%20Procedures) The company is involved in two significant legal proceedings: a dispute with Elion Oncology, Inc. over a license agreement and a lawsuit alleging fraud from a 2021 private offering - The company is in a legal dispute with Elion Oncology, Inc. regarding the termination of a license agreement. The company believes Elion's claims are without merit and has filed a complaint seeking damages and injunctive relief[94](index=94&type=chunk) - A lawsuit was filed against the company by two investors from a February 2021 private offering, alleging fraud and negligent misrepresentation. The company has filed a motion to dismiss the complaint[96](index=96&type=chunk) [Risk Factors](index=20&type=section&id=Item%201A.%20Risk%20Factors) This section updates risk factors, highlighting potential FDA disruptions and Nasdaq delisting risk due to failing to maintain the minimum bid price - A new risk factor was added concerning potential disruptions at the FDA, such as funding cuts and staffing issues, which could hinder the timely approval of new products[99](index=99&type=chunk)[100](index=100&type=chunk) - On February 4, 2025, the company received a deficiency letter from Nasdaq for failing to maintain a minimum bid price of **$1.00** per share. The company has until August 4, 2025, to regain compliance[101](index=101&type=chunk) - Potential delisting from Nasdaq could lead to significant adverse consequences, including reduced liquidity, classification as a "penny stock," and a decreased ability to obtain future financing[101](index=101&type=chunk)[108](index=108&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=20&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) In Q1 2025, the company issued **6,252** shares of common stock to Berg Capital Markets, LLC as part of a consulting agreement, relying on registration exemptions - During the quarter ended March 31, 2025, the company issued **6,252** shares of common stock to Berg Capital Markets, LLC in connection with a consulting agreement[103](index=103&type=chunk) - The shares were issued as restricted securities, exempt from registration requirements in reliance on Section 4(a)(2) of the Securities Act[103](index=103&type=chunk) [Defaults Upon Senior Securities](index=20&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - None[104](index=104&type=chunk) [Mine Safety Disclosures](index=20&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[105](index=105&type=chunk) [Other Information](index=20&type=section&id=Item%205.%20Other%20Information) During Q1 2025, no directors or officers adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement - No directors or officers adopted or terminated a "Rule 10b5-1 trading arrangement" or a "non-Rule 10b5-1 trading arrangement" during the three months ended March 31, 2025[106](index=106&type=chunk) [Exhibits](index=20&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including warrants, agreements related to the January 2025 financing, and officer certifications - The report includes exhibits related to the January 2025 public offering, such as the forms for Series A and B Common Warrants, Pre-Funded Warrants, the Securities Purchase Agreement, and the Placement Agency Agreement[107](index=107&type=chunk)[109](index=109&type=chunk) - Certifications by the Principal Executive Officer and Principal Financial Officer are also filed as exhibits[109](index=109&type=chunk)

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].