Processa Pharmaceuticals, Inc. · NASDAQ:PCSA
Processa Pharmaceuticals — Investor Presentation (December 2022)
39 slides from Processa Pharmaceuticals's investor presentation, Dec 22, 2022
Slide 1: Processa Pharmaceuticals, Inc.
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) December 2022 GA Processa Pharmaceuticals
Slide 2: Disclaimer: Forward Looking Statements
Disclaimer: Forward Looking Statements The following summary is provided for informational purposes only and does not constitute an offer or solicitation to acquire interests in the investment or any related or associated company. The information contained here is general in nature and is not intend
Slide 3: Our People Lead to Success
Our People Lead to Success > 30 years ago members of the Processa Development Team were involved with 2 FDA contracts where the concept of Regulatory Science was conceived > Development Team members further developed the Processa Regulatory Science Approach while obtaining > 30 FDA approvals for ind
Slide 4: Pipeline of Assets that Differentiates Processa
Pipeline of Assets that Differentiates Processa Potential De-Risk Devel. with Regulatory Evidence of Clinical Advantages in Efficacy & Prior Development Supporting Data Greater Probability of Unmet Medical Need + Efficacy Evidence + Regulatory Science + Capital Efficiency = FDA Approval & High ROI *
Slide 5: Differentiated Business Model
a eee Processa Pharmaceuticals, Inc (NASDAQ: PCSA) Differentiated Business Model > Processa has a capital-efficient approach based on very low overhead, disciplined licensing, and intelligent/efficient development, all leading to a potentially high ROI (6 C-suite to received < $600,000 total cash sa
Slide 6: Pipeline of Five Drugs Each with $1B Market Opportunity
Pipeline of Five Drugs Each with $1B Market Opportunity Drug Disease Target Market Next Generation Metastatic Colorectal Cancer U.S. Incidence of Metastatic Colorectal Cancer : > 60K Pts Capecitabine and Other Types of Cancer U.S. Max Ann. Sales mCRC: $500 M - $1.0B (PCS6422) Phase 1B U.S. Max Ann.
Slide 7: Pipeline with High Value 2022-2023 Milestones
a Pipeline with High Value 2022-2023 Milestones Prioritize Oncology Assets While Being Opportunistic with Non-Oncology Assets Conduct Clinical Trials and Interact with FDA to Expand Licensing/Partnering Opportu 1S Drug Disease Target Non- Phase | Phase | Phase Status Milestones clin 1 2 3 Next Gener
Slide 8: Next Generation Capecitabine (NGC)
@ Processa Pharmaceuticals Next Generation Capecitabine (NGC) (Combination Regimens of PCS6422 and Capecitabine) Metastatic Colorectal Cancer, Breast Cancer, Pancreatic Cancer, Other Cancers
Slide 9: 5-Fluorouracil Approved by FDA in 1962 & Capecitabine Approved in 1998
5-Fluorourcail Approved by FDA in 1962 & Capecitabine (Oral Form of 5-Fluorouracil) Approved by FDA in 1998 Capecitabine (Xeloda®) ~ 75% - 85% of 5-FU Metabolizes (Catabolites) ~ 10% - 20% of 5-FU Metabolizes (Anabolites) Anti-Tumor Response FBAL a DPD. Side Effects (Dihydropyrimidine (eg, HFS) Dehy
Slide 10: Next Generation Capecitabine (NGC): Improved Efficacy & Side Effect Profile
Next Generation Capecitabine (NGC): Improved Efficacy & Side Effect Profile PCS6422 Irreversibly Inhibits DPD (Dihydropyrimidine Dehydrogenase Enzyme) > By combining a regimen of PCS6422 Capecitabine with a capecitabine regimen, the 5-FU (Xeloda®) formed from capecitabine is only metabolized to anab
Slide 11: Why Does Processa Believe in NGC: Evidence of Clinical Benefit
Why Does Processa Believe in NGC: Evidence of Clinical Benefit > Safety Differentiation of NGC vs Existing Chemotherapy 7 Decrease Incidence of HFS + 50-70% of capecitabine patients have adverse events from =i» {Grade 96:4) FBAL Side Effects FBAL resulting in decreasing capecitabine dose or stopping
Slide 12: Moving Closer to NDA: Phase 1B Trial to Evaluate Safety
Moving Closer to NDA: Phase 1B Trial to Evaluate Safety PCS6422 PCS6422 PCS6422 Regimen A Regimen B (Exposure > Reg A) Regimen D (Exposure Similar to Reg A) Capecitabine 0 DLTs (1 Pt) Regimen 1 Capecitabine 0 DLTs (3 Pts) 2 DLTs (5 Pts) Discontinued DLTs TBD Regimen 2 (Exp > Reg 1) (neutropenia, muc
Slide 13: FDA Project Optimus
FDA Project Optimus Cytotoxic Chemotherapy Toxicity 7 / Efficacy EffectResponse 080100 200-400 00 Dose/Drug Exposure Assumptions with MTD Approach Toxicity .§ Efficacy EffectResponse o- o° 80 100 20 400 800 ee POSe/Drug Exposure Assumptions with Project Optimus Gr Vv Vv Vv Historical Approach To Ide
Slide 14: Next Generation Capecitabine (NGC) in 2023
Next Generation Capecitabine (NGC) in 2023 Development and Regulatory Potential NGC regimens have been identified for a Phase 2B trial which will provide the regimen/exposure range required for FDA's Project Optimus Oncology Initiative to define a regimen that will provide an FDA-approvable benefit/
Slide 15: PCS12852
@ Processa Pharmaceuticals PCS12852 GI Motility Conditions (eg, Gastroparesis)
Slide 16: Gastroparesis
Gastroparesis Gastroparesis Symptoms Normal Gastric Emptying Gastroparesis Mild — Severe: > Heartburn, too much bloating, belching Moderate — Severe: ) loved dylerie —-_—Perlastattic thineter contractions > Feeling full soon after starting a meal or long after eating a meal > Nausea > Vomiting > Upp
Slide 17: Treatment of Gastroparesis (> $1.5B Market)
Treatment of Gastroparesis (> $1.5B Market) > Existing FDA approved drugs and off-labeled prescribed drugs are mainly used for the treatment of diabetic gastroparesis > All these drugs have a poor side effect profile limiting their use > Present market size for gastroparesis is estimated to be over
Slide 18: PCS12852: 5-HT4 Receptor Agonist - Wide Range of GI Motility Disorders
PCS12852: 5-HT4 Receptor Agonist - Wide Range of GI Motility Disorders Clinically Proven Mechanism of Action > Enhancement of both GI motility & secretion via increased Ach, 5-HT, Cl-and mucus release > Neural anti-inflammatory effects on post-operative ileus by inhibiting macrophage and neutrophil
Slide 19: PCS12852 Increase Gastric Emptying
PCS12852 Increase Gastric Emptying PCS12852 is a More Potent and More Selective 5HT4 Agonist than Previous 5HT4 Agonists Phased 2A Trial in Healthy Volunteers & Constipation Patients 7-8 patients per group Healthy Volunteers (< 3 Bowel Movements per Wk) or Functional Constipation Patients 80 60 20 G
Slide 20: PCS12852 Clinically Improves Gastroparesis Symptoms
PCS12852 Clinically Improves Gastroparesis Symptoms Percentage of Patients with a Clinically Meaningful (>0.5) response from Baseline to Day 28inTota >» A 0.5 mg PCS12852 daily dose over 28 days resulted in a GCSI Score clinically meaningful improvement in gastroparesis symptoms as defined by greate
Slide 21: PCS12852 in 2023
PCS12852 in 2023 Development and Regulatory Meet with the FDA the 1H2023 to define the next steps of the gastroparesis development program and to agree on the design of the Phase 2B trial Evaluate additional regulatory approaches to expedite the development program Evaluate current studies to determ
Slide 22: PCS499
G Processa Pharmaceuticals PCS499 Ulcerative Necrobiosis Lipoidica (uNL) and Other Indications
Slide 23: PCS499: Would be the First Drug Approved to Treat Ulcerative Necrobiosis Lipoidica
PCS499: Would be the First Drug Approved to Treat Ulcerative Necrobiosis Lipoidica (UNL) or Any Form of NL > Skin, tissue below the skin becomes necrotic forming open ulcers; Severe NL Mild NL can last from months to years with complications such as E infections, amputation, and cancer > Literature
Slide 24: Unmet Medical Need, Evidence of Clinical Efficacy
a Unmet Medical Need, Evidence of Clinical Efficacy > No FDA approved treatment for uNL or NL, no standard of care, all treatments are inadequate > Drugs have been used off-label with mixed success (e.g., pentoxifylline (PTX)); provide poor safety profile given their limited efficacy > PCS499 is the
Slide 25: PCS499 Phase 2A Trial Demonstrates Complete Ulcer Closure
PCS499 Phase 2A Trial Demonstrates Complete Ulcer Closure > 1.8 gm/d of 499 has a better safety profile than 1.2 gm of PTX in animal tox studies and Phase 1 healthy human volunteer studies > Determined 1.8 gm/d of 499 was safe in 12 NL patients and effective in closing the open ulcers of the 2 patie
Slide 26: PCS499 in 2023
PCS499 in 2023 Development and Regulatory Complete enrollment of the interim analysis group in 1H2023 and evaluate the likelihood of completing full enrollment Meet with FDA and submit an IND for a second indication for PCS499, an indication that requires the diverse pharmacology of PCS499 Evaluate
Slide 27: Financial Highlights and Capital Structure
Financial Highlights and Capital Structure > Our cash on hand on September 30, 2022 of $9.1 million provides a cash runway into the third quarter of 2023. > Overhead Only Cash Burn, including development team salaries, is expected to be less than $4.5 million in 2022. > Shares Outstanding on Septemb
Slide 28: Backup Slides
G Processa Pharmaceuticals BACKUP SLIDES Overview of Intellectual Property and Other Oncology Drugs to Treat Metastatic Pancreatic, Biliary, Small Cell Lung, and Other Cancers
Slide 29: Intellectual Property Overview
Intellectual Property Overview Program Description of IP Status Substituted xanthine derivatives and 2 Composition of Matter Issued PCS499 deuterium substituted Methods of treating hyperglycemia Preventing neurotoxicity and combination 2 Method patents Issued with 5FU and 5-FU prodrugs Additional pr
Slide 30: PCS3117
G Processa Pharmaceuticals PCS3117 Metastatic Pancreatic Cancer, Biliary Cancer, Other Cancers
Slide 31: 1H'22 - PCS3117 Biomarker Assay Development Completed
1H’22 - PCS3117 Biomarker Assay Development Completed NH NH NH) Sn Sn ae we [ N (e) N ie) HO Kw F HO. o. NW SO HO, fo) ; OH OH OH OF RX-3117 Gemcitabine (dFdC) OH SH Oral Administration IV Administration Cytidine (Cytosine + Ribose Analog) (Cytosine + F,F-Deoxyribose) (Cytosine + Ribose Ring) > Gemc
Slide 32: PCS3117 for Cancer Patients Resistant to Gemcitabine
PCS3117 for Cancer Patients Resistant to Gemcitabine > PCS3117 has a similar structure to gemcitabine but is activated through a different pathway and causes cancer cell apoptosis in more ways than gemcitabine > PCS3117 has been shown in gemcitabine resistant cancer patients and tumor animal models
Slide 33: PCS3117 Prior Evidence of Clinical Efficacy and Safety in Cancer Patients
a PCS3117 Prior Evidence of Clinical Efficacy and Safety in Cancer Patients > PCS3117 monotherapy Phase 2A trial as second or third-line therapy in patients with progressive metastatic pancreatic cancer after 1-5 previous therapies of chemotherapy (93% (40/43) refractory to gemcitabine) * 31% (14 pa
Slide 34: 2023 Milestones - PCS3117
2023 Milestones - PCS3117 Development and Regulatory > Complete the evaluation of potential biomarkers in pancreatic cancer patients to determine if biomarkers can identify potential responders to 3117 as 1* line therapy prior to treatment using a Precision Medicine approach > Although 3117 already
Slide 35: PCS11T
@ Processa Pharmaceuticals PCS11T Small Cell Lung, Pancreatic, Colorectal, Other Cancers
Slide 36: PCS11T: Lipophilic Prodrug of SN-38
PCS11T: Lipophilic Prodrug of SN-38 (lrinotecan Active Metabolite) Vv Pro-drug of SN-38 linking SN-38 to a molecular nano-motor (MNM), a proprietary compound, which interacts with cell membranes preferentially accumulating in the membrane of tumor cells and the tumor core more than normal cells Vv C
Slide 37: Higher and More Selective Tumor Exposure to SN38 with PCS11T
Higher and More Selective Tumor Exposure to SN38 with PCS11T (formerly ATT-11T) versus Irinotecan Tumor-bearing mice had 200x higher drug in tumor vs muscle compared to 15x with Irinotecan 20 120 Muscle | Muscle 100 Plasma 100 | oe Plasma Tumor =e Tumor 80 | so | 3 3 | Py = 60 Tumor/muscle = 200 < 6
Slide 38: Efficacy Maintained at Lower Doses of PCS11T When Compared to Irinotecan
a Efficacy Maintained at Lower Doses of PCS11T When Compared to Irinotecan in SW620 Colorectal Cancer Xenograft Model MTD Tumor volume, mm? =e Grp#: Control 2 GrpH2: CPT-11 100me/kg ip % MTD 1200 =e Grpi1: Control 4000 -| <*@e+ Grp#5: CPT-11 Some/kg, ip oe Grp: ATT-11T 75me/kg, ip 11 13 15 17 19 21
Slide 39: PCS11T in 2023
PCS11T in 2023 Development and Regulatory > Drug Substance manufacturing site has been selected and Drug Product manufacturing sites are being evaluated > Drug development “roadmaps” are being developed for lung, pancreatic, colorectal, and other potential cancers > Complete manufacturing of Drug Su
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