Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Investor Presentation (February 2025)
25 slides from Processa Pharmaceuticals's investor presentation, Feb 11, 2025
Slide 1: Nasdaq: PCSA
Nasdaq: PCSA
Slide 2: Forward-Looking Statement and Disclosures
Forward-Looking Statement and Disclosures @ Process Pharmaceuticals This presentation includes forward-looking statements based upon our current expectations. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predic
Slide 3: About Processa Pharmaceuticals
Processa Pharmaceuticals About Processa Pharmaceuticals De-Risked Strategy for New Cancer Therapy * Improving the distribution and/or metabolism of existing, proven anti-cancer agents as NCEs - Reducing side effects - Increasing efficacy - Improving potency * Three anti-cancer NCEs with multiple nea
Slide 4: Large Market Opportunity in Oncology
Large Market Opportunity in Oncology Cancer is the Second Leading Cause of Death in the U.S. Two million new cancer cases expected in 2024 and approximately 611,720 deaths Select Cancer Indications 2024 Estimates in U.S. New Cases Deaths 8 ee — iif “se arc Cane Sony 208 (Glorecum nudes appandc Malae
Slide 5: Our Approach to Next Generation Cancer Therapy (NGC)
Our Approach to Next Generation Cancer Therapy (NGC) @ recs Pharmaceuicas Excellent Risk-Reward: Improving drugs that we know already work Industry’s approach - Search for novel or different ways to treat cancer - exciting, novel technology (gets headlines) - High failure rate in clinic and market (
Slide 6: Pipeline
Pipeline GP Processa Pharmaceuticals Improving Safety and Efficacy Stage of Development Breast, Colorectal, NGC-Cap Hepatocellular, (Pcs6422) Pancreatic, Gastric, & Other Solid Tumor 2H25: Interim analysis of Phase 2 trial in advanced or metastatic breast cancer Capecitabine Cancers qecoeeth non-sma
Slide 7: NGC-Cap: What Is Capecitabine?
NGC-Cap: What Is Capecitabine? Commonly Used Anti-cancer Drug with Significant Side Effects * Capecitabine - Oral prodrug of 5-fluorouracil (5-FU) - Capecitabine and 5-FU are among the most widely used cancer chemotherapy agents in the treatment of solid tumors such as breast and GI cancer * Only 20
Slide 8: NGC-Cap: How We Improve Capecitabine Therapy
NGC-Cap: How We Improve Capecitabine Therapy Processa Pharmaceuticals Increased cancer-killing anabolites in tumor; Reduced catabolites (side effects) outside tumor Capecitabine (Xeloda’) ~ 75% - 85% to FBAL catabolites Side Effects (e.g, HFS) & No Anti-Tumor Properties ~ 80% - 90% to anabolites Can
Slide 9: NGC-Cap: Study Results To Date
NGC-Cap: Study Results To Date @ Process Pharmaceuticals Better Tolerated than Capecitabine with Preliminary Positive Efficacy Phase 1b Design Results * Capecitabine dose escalating 3+3 design ° 5-10x greater exposure to its 5-FU cancer treatment with PCS6422 in patients with advanced, metabolite th
Slide 10: NGC-Cap: Phase 2 Study Design
NGC-Cap: Phase 2 Study Design Based on Discussions with and Recommendations from the FDA Ongoing Phase 2 clinical trial * Global multicenter, open-label, adaptive designed trial = 60 to 90 patients with advanced or metastatic breast cancer - Up to 30 global trial sites * Evaluating safety-efficacy p
Slide 11: NGC-Cap summary: efficacy, side effects, IP, clinical development
GP Processa Pharmaceuticals Efficacy ont + Alters metabolism to increase formation and distribution of 5-FU and cancer-killing molecules to cancer cells while reducing the metabolites that only cause side effects + Active molecule same as Capecitabine but provides improved treatment 2 Side Effects +
Slide 12: NGC-Gem: What is Gemcitabine?
7a NGC-Gem: What is Gemcitabine? oz @ Procesa Pharmaceuticals Standard of care drug with known resistance * Gemcitabine is widely used in pancreatic, gall bladder, lung, and other solid tumor cancers * Approximately 20% - 40% of patients respond to Gemcitabine across solid tumor cancers * Resistance
Slide 13: NGC-Gem: Improves Metabolism of Gemcitabine
NGC-Gem: Improves Metabolism of Gemcitabine @ Provessa Pharmaceuticals dck 16 tee ‘ou In some cancers CL os wo dCK Expression < UCK2 Expression . = resulting in metabolism to more A) 2 cancer-killing molecules e 7 af > Gemcitabine (dFdC) for NGC-Gernthan:Gem NGC-Gem IV Administration ral —=__| Admin
Slide 14: NGC-Gem: Phase 2a Safety and Efficacy in Pancreatic Cancer
NGC-Gem: Phase 2 Safety and Efficacy in Pancreatic Cancer @ Process Pharmaceuticals 31% (14 patients) had progression-free survival for 8 weeks or more 12% (5 patients) had stable disease for more than 4 months One patient had a tumor reduction of 40% after 28 days of treatment Mild to moderate adve
Slide 15: NGC-Gem summary: efficacy, side effects, IP, clinical development
@ Processa Pharmaceuticals Efficacy * Positive results demonstrated in Phase 2a trial in pancreatic cancer patients gp + Cancer cells exposed to more NGC-Gem cancer-killing molecules due to improved activating enzyme 2 Side Effects + Side-effect profile similar to Gemcitabine ef Intellectual Propert
Slide 16: NGC-Iri: What is Irinotecan?
Processa Pharmaceut NGC-Iri: What is Irinotecan? Effective Chemotherapy for Solid Tumors With Black Box Warning * lrinotecan is widely used in lung, pancreatic, ovarian, cervical & other solid tumor cancers * Onivyde® is irinotecan in a liposomal formulation + Approximately 15-35% of patients respon
Slide 17: NGC-Iri: What is NGC-Iri?
NGC-Iri: What is NGC-Iri? Q rrneas Pucca Safer and More Effective Cancer Therapy Without Black Box Warning * NGC-Iri is a prodrug of SN-38, the active metabolite of irinotecan and Onivyde® * NGC-lIri preferentially accumulates in the membrane of tumor cells over the membrane of normal cells releasin
Slide 18: NGC-Iri: Higher Amounts & Lower Required Dose
NGC-Iri: Higher Amounts & Lower Required Dose Processa Pharmaceuticals Tumor-Bearing Mice had 200x Higher Drug in Tumor Versus Muscle Compared to 15x with Irinotecan NGC-Iri SN-38, ng/g 320 @ Tumor @ Plasma © Muscle Irinotecan a © Tumor @ Plasma 200 SN-38, ng/g g NGCAri stecan Tissue Tumor/Tissue Ra
Slide 19: NGC-Iri: Higher Amounts & Lower Required Dose
Processa Pharmaceuticals NGC-Iri: Higher Amounts & Lower Required Dose Efficacy Maintained at Lower Doses of NGC-iri When Compared to Irinotecan in $W620 Colorectal Cancer Xenograft Model NGC-lri lrinotecan Lower Dose MTD Efficacy Effect or Response Effect or Response Dose or Drug Exposure NGC-Irin
Slide 20: NGC-Iri: Comparing NGC-Iri with Irinotecan and Onivyde
NGC-Iri: Comparing NGC-Iri with Irinotecan and Onivyde® — @ Process Pharmaceuticals Supports Potential for a Better Safety Profile with NGC-Iri « Accumulation of SN-38 in the tumor compared with other tissues was greater after NGC-Iri administration than after irinotecan or Onivyde® administration =
Slide 21: NGC-Iri summary: efficacy, side effects, IP, clinical development
GP Processa Pharmaceuticals Efficacy ont + Active molecule SN-38 is same active molecule in Irinotecan + Distributes SN-38 differently, entering the cell membrane of cancer cells preferentially over normal cells, improving cancer-killing effect 2 Side Effects + Given the specificity of NGC-Iri for c
Slide 22: Product Partnering Opportunities
Product Partnering Opportunities PCS12852 to treat gastroparesis + Best-in-class 5-HT4 receptor agonist for disease with high unmet medical need + Completed P2a with positive results showing excellent safety and efficacy profile + Outstanding safety profile and selectivity combine to provide first m
Slide 23: Processa Senior Management
Processa Senior Management GP Processa Pharmaceuticals George Ng David Young, Pharm.D., Ph.D. Sian Bigora, Pharm.D. Chief Executive Officer President, Research and Development ]_ St evelopment Off Officer CALD == @QueEsrcor agi (&Questcor “eaursreon a @srecrrum = DSCILEX Cy) geunz ©) » Patrick Lin R
Slide 24: Company Summary
Processa Pharmaceuticals Company Summary Track record of drug development through regulatory approval using proprietary Regulatory Science Approach De-risked strategy to develop more effective cancer therapy options with improved tolerability for cancer patients through an efficient regulatory path
Slide 25: Investor Relations contact
@ Processa Pharma Alliance Advisors Investor Relation Yvonne Briggs ybriggs@allianceadvisors.com Nasdaq: PCSA
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