Slide 1: Processa Pharmaceuticals: Next Generation Chemotherapy
GB Processa Pharmaceuticals Next Generation Chemotherapy David Young, PharmD, PhD President and CEO Biotech Showcase
Slide 2: Disclaimer: Forward Looking Statements
Disclaimer: Forward Looking Statements The following summary is provided for informational Forward-looking statements, by their very nature, purposes only and does not constitute an offer or are subject to uncertainties and contingencies and solicitation to acquire interests in the investment or ass
Slide 3: Investment Opportunity with De-Risked Next Generation Chemotherapy
Investment Opportunity with De-Risked Next Generation Chemotherapy Successful, Experienced Team Processa Regulatory Science Approach Capitalizing on yA Project Optimus / Oncology Initiative / Next Generation Chemotherapy Substantial Market Opportunities Capital Efficient strategy Significant inflect
Slide 4: Management Team Involved With Billion-Dollar Exits
Management Team Involved With Billion-Dollar Exits (Questcor - $5.7 B & Gentium - $1.0 B) & Two FDA Contracts Where Regulatory Science Was Conceived 3 David Young, Pharm.D, Ph.D. i) Sian Bigora, Pharm.D. a] Michael Floyd 4 President & CEO Chief Development Officer Chief Operating Officer Former Role
Slide 5: Three Next Generation Chemotherapy Drugs with Routes to Approval
Three Next Generation Chemotherapy Drugs with Routes to Approval Next Regulatory Generation Science \ Drugs Approach ~ Consistent with FDA Project Optimus Initiative High Probability of Approval &
Slide 6: FDA Project Optimus: Evaluate Safety & Efficacy as a Function of Drug Exposure
FDA Project Optimus: Evaluate Safety & Efficacy as a Function of Drug Exposure >» Maximum Tolerated Dose (MTD): Historically, Used to ‘Assumption determine efficacious dose while assuming toxicity & efficacy with MTD follow a parallel path. Approach > FDA Project Optimus Oncology Initiative: Evaluat
Slide 7: Regulatory Science Approach
Regulatory Science Approach Conceived from 2 FDA Contracts with the Approach Resulting In > 30 FDA Approvals For Indications Across FDA Risk And Benefit Are More Than Adverse Event And Efficacy Response Present Treatment Options What Influences the Risk/Benefit |~Benefit” Existing Therapy (On-Label
Slide 8: Processa Pipeline of Drugs, Each with > $1B Market
a Processa Pipeline of Drugs, Each with > $1B Market Next Generation Chemotherapy Improving Safety and Efficacy 2H 2022 1H 2023 : 2H 2023 1H 2024 | 2H 2024+ Next Generation Capecitabine Define Exp./Re: Complete Ph 1B & initia Colorectal, Breast, Gastric, Pancreatic, Proj ie 9: Phase 2B design; Proj.
Slide 9: Next Generation Capecitabine (NGC)
fy Processa Pharmaceuticals Next Generation Capecitabine (NGC) (Combination Regimens of PCS6422 and Capecitabine) Colorectal Cancer, Gastric, Breast Cancer,
Slide 10: 5-FU & Capecitabine - Most Widely Used Cancer Chemotherapy Agents
5-FU & Capecitabine - Most Widely Used Cancer Chemotherapy Agents + 50% - 70% of Patients on Capecitabine Have Dose- Limiting Side Effects Requiring Change in Therapy; + Approximately 60% Of Patients Do Not Respond Or Are Partial Responders Capecitabine (Xeloda®) ~ 10% - 20% of 5-FU ~ 75% - 85% of 5
Slide 11: Why Believe in NGC (PCS6422+Capecitabine): Evidence of Clinical Benefit
Why Believe in NGC (PCS6422+Capecitabine): Evidence of Clinical Benefit > PCS6422 + 5-FU Safety is Better than Existing Chemotherapy * APS (Grade a8) FAL Side Effects + 50-70% of Capecitabine patients have adverse events from FBAL resulting in decreasing Capecitabine dose or stopping - % pationts 10
Slide 12: NGC Project Optimus: Evaluate Safety as a Function of Drug Exposure
NGC Project Optimus: Evaluate Safety as a Function of Drug Exposure and 6422 Regimens in Phase 1B Trial Evaluate Safety vs Exposure As Project Optimus Requires Toxicity 5-FU Exposure Level 1 0/1 0/1 1004 Toxicity Efficacy (NGC Regimen A) a 5-FU Exposure Level 2 0/5 0/5 (NGC Regimen B) 5-FU Exposure
Slide 13: NGC Project Optimus Objectives in 2023
NGC Project Optimus Objectives in 2023 Need To Evaluate Safety And Efficacy As A Function Of Drug Exposure & NGC Regimens In Phase 2B Trial > 5-FU exposure and NGC regimens have been identified for a Phase 2B trial which will provide the exposure range required for FDA's Project Optimus Oncology Ini
Slide 14: PCS3117
Ly Processa Pharmaceuticals PCS3117 Pancreatic Cancer, Adjuvant Therapy for Pancreatic Cancer, Biliary Cancer, Non-Small Cell Lung, and
Slide 15: PCS3117: Next Generation Gemcitabine
PCS3117: Next Generation Gemcitabine OH OH OH F PCS3117 Gemcitabine (dFdC) Oral Administration IV Administration (Cytosine + Ribose Analog) (Cytosine + F,F-Deoxyribose) > PCS3117 is the "Next Generation" of FDA-approved Gemcitabine. * PCS3117 is more efficacious than Gemcitabine with a similar safet
Slide 16: PCS3117 Opportunity
PCS3117 Opportunity > Gemcitabine is the most widely used chemotherapeutic agent used to treat pancreatic, non-small cell lung, and biliary cancer. PCS3117 Segment ~ Currently $1 B U.S. > U.S. pancreatic cancer Gemcitabine sales: ~ $1 B; U.S. market for all Gross Sales cancer/indications is > $1.5B.
Slide 17: PCS3117 - UCK2 Level as a Predictive Biomarker
PCS3117 - UCK2 Level as a Predictive Biomarker Higher UCK2 Expressions In Human Pancreatic Tumors Compared To Normal Tissue UCK2 Expression dCK Expression (Enzyme Activating PCS3117) (Enzyme Activating Gemcitabine) N=! log10(FPKM) 12 log1 0(FPKM) 0.0 L y Pa_P : Pancreatic Tumor, N=134 Pa_R : Normal
Slide 18: PCS3117 Prior Evidence of Clinical Safety and Efficacy in Pancreatic Cancer Patients
PCS3117 Prior Evidence of Clinical Safety and Efficacy in Pancreatic Cancer Patients Days on Study Ee > 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
Slide 19: PCS3117 Milestones in 2023
PCS3117 Milestones in 2023 > Complete the evaluation of potential biomarkers in pancreatic cancer patients to identify potential responders to PCS3117 as 1st line therapy prior to treatment using a Precision Medicine approach in 1H2023. > Complete the evaluation of potential biomarkers in pancreatic
Slide 20: PCS11T
Zy Processa Pharmaceuticals — PCS11T Colorectal, Lung, Pancreatic, Cervical and
Slide 21: PCS11T (Next Generation Irinotecan): Lipophilic Prodrug of SN-38
ee PCS11T (Next Generation Irinotecan): Lipophilic Prodrug of SN-38 (Irinotecan Active Metabolite) > 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 c
Slide 22: Importance of Regulatory Science and Project Optimus for PCS11T
Importance of Regulatory Science and Project Optimus for PCS11T, Next Generation Irinotecan Tumor-Bearing Mice Had 200x Higher Drug In Tumor vs Muscle Compared To 15x With Efficacy Maintained at Lower Doses of PCS11T When Compared to Irinotecan in SW620 Colorectal Irinotecan Cancer Xenograft Model M
Slide 23: PCS11T Milestones in 2023
Neen ee ee PCS11T Milestones in 2023 > 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 Subst
Slide 24: 2022 Key Accomplishments and 2023 Anticipated Key Events
2022 Key Accomplishments and 2023 Anticipated Key Events Next Generation Treatment 2022 Key Accomplishments 2023 Anticipated Key Events A v Identified DPD inhibition and de novo formation Next Generation ran timeline. ari v ldentified safe and dose limiting 5-FU exposure levels and NGC dosage regime
Slide 25: Intellectual Property and Market Exclusivity
a Intellectual Property and Market Exclusivity Program Description of IP Overview of Patent Expiration Dates and Market Exclusivity Existing Patents, Provisional Patents 2042 To Be Submitted Patents 2043 PCS6422 Potential FDA Market Exclusivity 7 Years after approval Existing Patents, Provisional Pa
Slide 26: Financial Highlights and Capital Structure
Financial Highlights and Capital Structure > Cash on September 30, 2022, of $9.1 million provides a cash runway into the third quarter of 2023. > Overhead only cash burn, including salaries, is expected to be less than $4.5 million in 2022. > Shares Outstanding on September 30 , 2022 was 15,895,087,
Slide 27: Investment Opportunity with De-Risked Next Generation Chemotherapy
Investment Opportunity with De-Risked Next Generation Chemotherapy Successful, Experienced Team Processa Regulatory Science Approach Capitalizing on yA Project Optimus / Oncology Initiative / Next Generation Chemotherapy Substantial Market Opportunities Capital Efficient strategy Significant inflect
Slide 28: Backup Slides
Ze Processa Pharmaceuticals Backup Slides
Slide 29: PCS12852 Gastroparesis
i Processa Pharmaceuticals — PCS12852 Gastroparesis
Slide 30: Gastroparesis
Gastroparesis Gastroparesis Symptoms Normal Gastric Emptying Gastroparesis Mild — Severe: > Heartburn, too much bloating, belching Moderate — Severe: > Feeling full soon after starting a meal or long after eating a meal > Nausea > Vomiting > Upper abdominal pain > Early satiety > Target Indication:
Slide 31: 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 32: 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 33: 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 & U.S. Phase 2A Proof-of-Concept Trial in Constipation Patients Gastroparesis Patients 7 —8 patients per group Healthy Volunteers (< 3 Bowel
Slide 34: PCS12852 Clinically Improves Gastroparesis Symptoms
Percent of Patients PCS12852 Clinically Improves Gastroparesis Symptoms rr) & 2 Percentage of Patients with a Clinically Meaningful (>0.5) response from Baseline to Day 28 in Total > GCSI Score 1000 > 83 > om 500 m5 i ; . 167 >05 change in total score from baseline to Day 28 Onl including patients t
Slide 35: PCS12852 Milestones in 2023
Neen ee PCS12852 Milestones in 2023 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 determine th
Slide 36: PCS499
& Processa Pharmaceuticals PCS499 Ulcerative Necrobiosis Lipoidica (uNL),
Slide 37: PCS499: Would be the First Drug Approved to Treat uNL
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; can Severe NL last from months to years with complications such as infections, r e amputation, and cancer. Literature reports
Slide 38: 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 39: 1.8 gm/d of 499 has a better safety profile than 1.2 gm of PTX
> 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 patients with uNL in an open-labeled Phase 2A trial. Baseline
Slide 40: PCS499 Milestones in 2023
a PCS499 Milestones in 2023 > 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 Venous Ulcers, a second indication that requires the diverse pharmacology of PCS499. > Evaluate additional regula