Core Viewpoint - Processa Pharmaceuticals is actively participating in the 44th Annual J.P. Morgan Healthcare Conference to discuss its clinical pipeline and engage with investors and potential partners [1][2]. Group 1: Company Overview - Processa Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing Next Generation Cancer (NGC) therapies with improved safety and efficacy [6]. - The company's NGC drugs are modifications of existing FDA-approved oncology therapies aimed at enhancing the metabolism and distribution of these drugs while preserving their cancer-killing mechanisms [6]. Group 2: Clinical Pipeline - The ongoing Phase 2 study is evaluating NGC-Cap in patients with advanced or metastatic breast cancer, with preliminary data indicating that NGC-Cap increases exposure to capecitabine's cancer-killing metabolites while maintaining a safety profile similar to standard capecitabine monotherapy [3][5]. - A formal interim analysis from the first 20 patients enrolled in the Phase 2 study is expected to be completed in early 2026 [3]. Group 3: Strategic Engagement - George Ng, CEO, and Patrick Lin, Chief Business & Strategy Officer, will be available for one-on-one meetings with investors during the conference to discuss the company's clinical pipeline [2][4].

Core Viewpoint - Processa Pharmaceuticals has completed the enrollment and dosing of 20 patients for an interim analysis in its Phase 2 clinical study evaluating NGC-Cap, a combination treatment for advanced or metastatic breast cancer, with results expected in Q1 2026 [2][3]. Study Design and Patient Characteristics - The Phase 2 study is randomized and FDA-recommended, comparing NGC-Cap (Arm A) with capecitabine monotherapy (Mono-Cap, Arm C) in patients who have undergone at least one prior cancer treatment, with a median of two to three prior regimens [4]. - NGC-Cap consists of PCS6422 administered one day prior to capecitabine, followed by capecitabine at 150 mg twice daily for seven days on and seven days off, while the Mono-Cap arm consists of capecitabine at 1,000 mg/m² twice daily for 14 days followed by seven days off [5]. Mechanism of Action - PCS6422 is designed to enhance the metabolism of capecitabine by increasing the formation of cancer-killing metabolites (anabolites) and decreasing the formation of side effect-associated metabolites (catabolites) [6]. Interim Analysis Objectives - The interim analysis aims to compare safety and preliminary efficacy outcomes between NGC-Cap and Mono-Cap, with key objectives including evaluating early clinical benefit signals and guiding potential dose optimization and study design adjustments [7][10]. About NGC-Cap - NGC-Cap is Processa's lead oncology asset, aimed at improving the therapeutic index of capecitabine-based therapy by increasing systemic exposure to active metabolites while reducing toxic metabolites [8]. Company Overview - Processa Pharmaceuticals is focused on developing Next Generation Cancer drugs that modify existing FDA-approved therapies to improve safety and efficacy, utilizing a Regulatory Science Approach to enhance tolerability for cancer patients [9].

Core Insights - Processa Pharmaceuticals' shares surged 122.3% following a positive clinical update on its mid-stage study of NGC-Cap for advanced or metastatic breast cancer [1][6] Clinical Study Overview - NGC-Cap, a combination of PCS6422 and Roche's Xeloda (capecitabine), is the lead asset in Processa Pharmaceuticals' pipeline, with 19 patients enrolled in the phase II study [2] - The preliminary analysis includes data from the first 16 patients, indicating a pharmacokinetic advantage of NGC-Cap over Xeloda monotherapy [3][4] Efficacy and Safety Profile - Preliminary phase II data show significantly higher exposure to active metabolites in patients treated with NGC-Cap, suggesting improved antitumor activity [4] - The pharmacologic profile indicates that NGC-Cap allows for greater delivery of effective components of Xeloda without worsening tolerability [5][6] - Early results suggest that increased exposure to active metabolites did not lead to more severe toxicity compared to Xeloda, with manageable tolerability despite higher pharmacologic activity [7] Side Effects and Tolerability - Patients on NGC-Cap experienced about ten times lower exposure to the toxic metabolite FBAL, associated with dose-limiting toxicities, leading to similar incidence of hand-foot syndrome (HFS) across treatment groups, but with milder symptoms in the NGC-Cap arm [8] - These findings support a differentiated safety profile for NGC-Cap, which could be appealing if sustained in later analyses [9] Future Expectations - Processa Pharmaceuticals aims to complete enrollment of the 20-patient cohort for the phase II interim analysis by the end of Q1 2026, with full results expected in early 2026 [9] - The company also has another investigational candidate in mid-stage development for rare kidney diseases [10]

Core Insights - Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) stock surged by 130.95% to $6.94 following a clinical update on its Phase 2 study of NGC-Cap, a combination treatment for advanced or metastatic breast cancer [7]. Clinical Study Findings - The first 16 of 19 patients in the Phase 2 study showed that NGC-Cap significantly increases exposure to capecitabine metabolites without increasing side effects compared to standard Mono-Cap therapy [2]. - Patients were randomized to receive either NGC-Cap (150 mg twice daily) or standard-dose Mono-Cap (1,000 mg/m² twice daily), with preliminary findings suggesting NGC-Cap allows for greater exposure to effective cancer-killing components while avoiding increased severity of side effects [3]. Safety and Side Effects - Although patients receiving NGC-Cap experienced a higher total number of side effects related to capecitabine metabolites, the severity of these side effects was similar between the two treatment groups, indicating that increased activity did not lead to more severe toxicity [4]. - Patients on NGC-Cap had substantially lower exposure to FBAL, a catabolite metabolite associated with side effects like hand-foot syndrome (HFS), with exposure being up to ten times less than that of Mono-Cap [5]. - The incidence of HFS was similar between treatment groups, but symptoms in the NGC-Cap group were mild (Grade 1), while those on Mono-Cap experienced more severe symptoms (up to Grade 2) [6]. Future Plans - Processa anticipates completing enrollment for the final patient in the 20-patient interim analysis of the Phase 2 safety and efficacy study by the end of Q1 2026 [7].

Preliminary Phase 2 data demonstrate PCS6422+Capecitabine increased cancer-killing metabolite exposure while maintaining comparable safety to monotherapy capecitabine Company on track to conduct formal interim analysis in early 2026 VERO BEACH, Fla., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies, today provided a clinical update on its ongoing Phase 2 study of NGC-Cap, the combinat ...

Core Insights - Biotech and healthcare stocks experienced significant movements in after-hours trading, driven by corporate updates and investor anticipation [1] Company Updates - Butterfly Network, Inc. (BFLY) shares increased by 6.04% to $2.81 after a 14.22% rise to $2.65 at market close, following the announcement of CEO Joseph DeVivo and Interim CFO Megan Carlson's participation in the 8th Annual Evercore Healthcare Conference [2] - Citius Pharmaceuticals Inc. (CTXR) saw a 7.90% increase to $1.23 after a 15.15% rally to $1.14, attributed to a deeper collaboration with Verix for the commercialization of LYMPHIR, an FDA-approved immunotherapy expected to launch in Q4 2025 [3] - ProQR Therapeutics N.V. (PRQR) rose 6.80% to $2.20 after a flat close at $2.06, with no specific news indicating that the movement may be due to investor sentiment [4] - Perrigo Company plc (PRGO) advanced 3.97% to $13.14, building on a 3.10% gain at the close, reflecting steady investor interest despite no new announcements [4] - Tempest Therapeutics, Inc. (TPST) added 4.86% to $3.67 after reversing a decline, following the announcement of plans to acquire CAR-T programs from Factor Bioscience, expected to close in early 2026 [5] - Iterum Therapeutics plc (ITRM) rose 2.77% to $0.3969 after a 4.38% gain at the close, with no new updates released [6] - Processa Pharmaceuticals, Inc. (PCSA) edged up 1.86% to $0.26 despite a steep decline at the close, with no news issued [6]

Financial Performance - Processa Pharmaceuticals reported a net loss of $3,436,573 for the three months ended September 30, 2025, compared to a net loss of $3,384,703 for the same period in 2024, reflecting an increase of $51,870[78]. - Operating loss for the nine months ended September 30, 2025, was $10,286,616, compared to $9,316,475 for the same period in 2024[78]. - The company generated a net loss of $10.2 million during the nine months ended September 30, 2025, with an accumulated deficit of $97.4 million[98]. - Other income for the three months ended September 30, 2025 was approximately $52,000, compared to $40,000 for the same period in 2024, and for the nine months ended September 30, 2025, it was approximately $74,000 versus $195,000 in 2024[88]. - Net cash used in operating activities for the nine months ended September 30, 2025 was $8,484,617, a decrease from $8,997,321 in 2024, attributed to timing of prepaid asset payments[92]. - The company has incurred losses since inception and does not expect positive cash flow from operations in the foreseeable future[98]. Research and Development - Research and development expenses for the three months ended September 30, 2025, were $1,661,646, a decrease of $625,879 from $2,287,525 in the same period in 2024[78]. - The NGC-Cap Phase 2 trial for advanced or metastatic breast cancer is actively enrolling patients, with preliminary safety-efficacy data expected to inform protocol modifications[69]. - PCS12852, a drug for gastroparesis, is Phase 2B ready, with a binding term sheet signed with Intact Therapeutics for potential licensing, including a $2.5 million payment upon execution[73]. - The company is evaluating the clinical safety and efficacy of PCS499 for primary glomerular diseases, with plans to meet with the FDA in Q4 2025 to discuss the Phase 3 study design[70]. - The company has a pipeline of Next Generation Cancer therapies, with NGC-Cap currently in Phase 2 and NGC-Iri in preclinical development[65]. Expenses and Cash Management - General and administrative expenses for the three months ended September 30, 2025 increased by approximately $681,000 to $1.8 million from $1.1 million for the same period in 2024, primarily due to salary increases and professional fees[86]. - For the nine months ended September 30, 2025, general and administrative expenses rose by approximately $831,000 to $4.6 million from $3.8 million in 2024, driven by salary increases and stock-based compensation[87]. - As of September 30, 2025, the company had cash and cash equivalents totaling $6.3 million, which, along with subsequent proceeds of $945,000, is expected to satisfy capital needs into the first quarter of 2026[97]. Capital Raising and Financing - The company raised net proceeds of $10.6 million through public offerings during the nine months ended September 30, 2025, selling 15,340,972 shares of common stock[71]. - During the nine months ended September 30, 2025, the company raised net proceeds of $12.9 million from selling shares and warrants in various offerings[95]. - The company plans to raise additional funds through equity offerings, debt financings, and strategic alliances, but may face challenges if adequate financing is not obtained[100]. - As of September 30, 2025, the company did not have any off-balance sheet arrangements[103]. Strategic Initiatives - Processa Pharmaceuticals is exploring options for its non-oncology drugs, which may include out-licensing or partnership opportunities[66]. - As of November 3, 2025, Processa Pharmaceuticals owned $850,000 in Digital Assets and plans to engage in capital raising transactions to purchase more Digital Assets[68].

Core Viewpoint - Processa Pharmaceuticals, Inc. announced the acceptance of its abstract for PCS499, aimed at treating Focal Segmental Glomerulosclerosis (FSGS), for presentation at the ASN Kidney Week 2025, highlighting the urgency for new therapies in this area [1][4]. Group 1: Presentation Details - The poster for PCS499 will be presented on November 7, 2025, during the session "Glomerular Clinical Trials: From Data to Impact" [2]. - The specific poster board number for the presentation is FR-PO0829 [2]. Group 2: Product Information - PCS499 is an analog of a metabolite of pentoxifylline (PTX), which has shown efficacy in reducing proteinuria but is limited by dose-related side effects [3]. - PCS499 has a favorable safety profile compared to PTX, allowing for higher dosing and potentially greater therapeutic benefits for rare kidney diseases like FSGS [3]. Group 3: Company Overview - Processa Pharmaceuticals focuses on developing Next Generation Cancer (NGC) therapies and innovative treatments for rare diseases, aiming to improve safety and efficacy [6]. - The company modifies existing FDA-approved oncology therapies to enhance their metabolism and distribution while maintaining their cancer-killing mechanisms [6].

Core Insights - Processa Pharmaceuticals Inc. (NASDAQ:PCSA) shares experienced a significant increase of 37.5% to $0.50 in after-hours trading, following a 29.03% gain during the regular session, closing at $0.36 [1] - Despite the recent surge, the company has faced challenges, with shares down 71.43% over the past year and 59.09% year to date, although there has been a 50% gain over the last six months [2] Clinical Development - Processa Pharmaceuticals is conducting a Phase 2 clinical trial for next-generation capecitabine (NGC-Cap) as a treatment for advanced or metastatic breast cancer, with the first patient treated in October 2024 [3] - The trial is a global, multicenter study comparing two doses of NGC-Cap with the FDA-approved drug capecitabine, involving 60 to 90 patients [3] - Interim analysis results are expected to be announced in mid-2025, as stated by David Young, President of Research and Development [4] Market Context - Breast cancer represents a significant market opportunity, with over 2 million cases diagnosed globally in 2022 and a five-year survival rate of approximately 30% for metastatic cases [6] - For the second quarter, Processa reported a loss of $0.25 per share, which was wider than the expected loss of $0.23, and the company generated no revenue during that quarter [6] - The third-quarter earnings report is scheduled for October 29 [6] Stock Performance - Over the past year, PCSA shares have traded between $0.15 and $1.50, with an average daily trading volume of 3.95 million shares and a market capitalization of $18.06 million [7] - Current trends indicate that PCSA is experiencing long-term consolidation according to Benzinga's Edge Stock Rankings [7]

Group 1: Telomir Pharmaceuticals Inc. (TELO) - Shares surged 43% in after-hours trading, climbing from $1.42 to $2.03 on light volume of 213,569 shares, below the average daily volume of 4.67 million [2] - The spike reflects renewed interest in recent in vitro data showing Telomir-1's ability to target additional histone demethylase families, indicating a unique epigenetic profile [3] Group 2: Processa Pharmaceuticals Inc. (PCSA) - Shares rose 32.6% in after-hours trading to $0.37, following a 30.9% gain during the regular session, with a closing price of $0.2790 on volume exceeding 31.9 million shares [4] - The price movement occurred without any official news or updates from the company, suggesting speculative momentum or technical positioning [5] Group 3: Reviva Pharmaceuticals Holdings Inc. (RVPH) - Shares increased 33.7% in after-hours trading to $0.8950 after a regular session gain of 22.8%, closing at $0.6693 with significant trading volume of 34.2 million shares [6] - The rally happened despite no recent official news, with the last update being four days prior regarding a healthcare conference [7] Group 4: NeuroOne Medical Technologies Corp. (NMTC) - Shares rose 9.5% in after-hours trading to $1.09, extending a 7.1% gain during the regular session, with a closing price of $0.9956 and trading volume of 1.21 million shares [8] - The increase followed the announcement of preliminary unaudited product revenue of $9.1 million for fiscal year 2025, up 163% from the prior year, and an upcoming virtual webinar [9] Group 5: BioRestorative Therapies Inc. (BRTX) - Shares edged 4.6% higher in after-hours trading to $1.60, following a modest 2% gain during the regular session, with a closing price of $1.53 and trading volume of 415,798 shares [10] - The increase followed the announcement of a $1.085 million registered direct offering priced at $1.60 per share, with proceeds aimed at advancing clinical trials and other corporate purposes [11]