Slide 1: 2022 Earnings Conference Call
@ Processa Pharmaceuticals 2022 Earnings Conference Call Development of Next Generation Chemotherapy Using Regulatory Science and Project Optimus David Young, PharmD, PhD President and CEO March 30, 2023
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: Processa Mission - Next Generation Chemotherapy
Processa Mission - Next Generation Chemotherapy Mission Statement When Company Formed To Develop Products to Improve the Survival and/or Quality of Life for Patients Who Have an Unmet Medical Need Condition Mission Statement in 2023 and Beyond To Develop the Next Generation Chemotherapies to Improve
Slide 4: Chemotherapy Remains the Backbone of Cancer Treatment
Chemotherapy Remains the Backbone of Cancer Treatment Next Generation Chemotherapy (NGC): Alter How the Existing Chemotherapy Drugs are Metabolized and/or Distributed in the Body (Capecitabine, Gemcitabine, lrinotecan) Q Capecitabine, Gemcitabine, and Irinotecan used in all types of cancers 30%-70%
Slide 5: Next Generation Chemotherapies (NGCs) - Modifications of Most Widely Used Existing Cancer Drugs
Next Generation Chemotherapies (NGCs) - Modifications of Most Widely Used Existing Cancer Drugs Most Oncology Companies Specialize in QO New oncology targets or Q Drug delivery (altering the administration of a drug) Absorption Drug Gets into the Body and Blood \ Processa Approach is Different aug M
Slide 6: Advantages of (NGC) Drugs
Advantages of Next Generation Chemotherapy (NGC) Drugs Q Fewer patients may have side effects that lead to discontinuation of NGCs or a decrease in the dose of NGCs. Q Cancer response to NGCs for an individual patient may be more significant with more patients likely responding to NGCs. Q Potential
Slide 7: Processa Different than Other Biotech and Pharma Companies
Processa Different than Other Biotech and Pharma Companies Efficiently Develop NGCs = Processa FDA-Approved Drugs Modified Regulatory j to Alter Metabolism and/or Distribution Drugs QO To obtain FDA-approval oncology drugs must now justify dosage regimen using principles of Project Optimus and Regul
Slide 8: Capecitabine (NGC-Cap)
@ Processa Pharmaceuticals Next Generation Chemotherapy Capecitabine (NGC-Cap) QO) Capecitabine - oral pro-drug of 5-FU widely used in many types of cancer including Colorectal, Gastric, Breast, Pancreatic, and Other Cancers (Incidence > 200,000) QO) NGC-Cap - combination treatment of PCS6422 (which
Slide 9: NGC-Capecitabine: Results Show Metabolism and Distribution of Key Metabolites Positively Altered
NGC-Capecitabine: Results Show Metabolism and Distribution of Key Metabolites of Capecitabine Positively Altered for Safer NGC-Cap Q Metabolism and distribution of Capecitabine has been 5-FU Exposure Level A 0/1 0/1 altered in NGC-Cap. (NGC Regimen A) Q NGC-Cap eliminates dose- li ing side effects (
Slide 10: Irinotecan (PCS11T)
ZF Processa Pharmaceuticals Next Generation Chemotherapy Irinotecan (PCS11T) QO) Irinotecan - Use in many types of cancer including Colorectal, Lung, Pancreatic, Cervical, and Other Cancers (Incidence > 200,000) 10
Slide 11: NGC-Irinotecan: Results Show NGC-Irin Positively Alters Distribution
a eee NGC-Irinotecan: Results Show NGC-Irin Positively Alters Distribution In our Project Optimus analysis, the efficacy of NGC-Irinotecan was maintained across a wide dose range (left Figure) while for FDA-approved Irinotecan (right Figure) efficacy across the dose range decreased as the dose decre
Slide 12: Milestones in 2022
Milestones in 2022 >» Next Generation Chemotherapy Milestones Provide Further Rationale for Implementing Project Optimus + Demonstrated NGCs altered the metabolism and/or distribution of the cancer drug or active metabolite compared to their FDA-approved counterparts. + Determined NGC-Cap drug expos
Slide 13: Milestones Goals in 2023
Milestones Goals in 2023 >» NGC-Capecitabine + Meet FDA mid-April to discuss Phase 2B safety-efficacy trial with interim analysis & next development steps. + Complete the Phase 1B trial to refine our understanding of the adverse event-exposure relationship. + Hope to initiate Phase 2B in 2H2023 with
Slide 14: ion Gemcitabine)
ion Gemcitabine) Non-Small Cell Lung, Ovarian, Breast & Other Cancers (Incidence > 275,000) atiol ecan) Colorectal, Pancreatic, Gastric, Li Ovarian, Cervical, & Other Cancers (Incidence > 200,000) jext Ger Candidates for Out-Licensing, Partnering, Spin-Off Ph2A PCS12852 Completed Moderate/Severe Gas