Panbela Therapeutics, Inc. · OTC:PBLA
Panbela Therapeutics — Investor Presentation (July 2023)
38 slides from Panbela Therapeutics's investor presentation, Jul 10, 2023
Slide 1: Investor Presentation July 2023
S Panbela. THERAPEUTICS Investor Presentation July 2023
Slide 2: Disclaimers
Disclaimers Certain statements in this presentation are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. Forward-looking statements are b
Slide 3: Company Presents A Unique Opportunity: Multi-Targeted Approach to Reset Dysregulated Biology
Company Presents A Unique Opportunity: Multi-Targeted Approach to Reset Dysregulated Biology Scientific focus on polyamines, key regulators of normal biology altered in many disease states Multiple near term inflection points CPP acquisition completed in 2022 to create complementary, multiproduct, m
Slide 4: Highly Experienced Management Team with Proven Track Record
Highly Experienced Management Team with Proven Track Record Proven orphan and oncology drug discovery, development and commercialization expertise Dr. Jennifer Simpson ‘Sue Horvath Rachel Bragg Chief Executive Officer Chief Financial Officer VP, Clinical Development 15+ Years 15+ Years 14+ Years Dr.
Slide 5: Dysregulation of the Polyamine Pathway Leads to Disease
; Dysregulation of the Polyamine Pathway Leads to Disease Cancer Pancreatic ductal adenocarcinoma Familial Adenomatous Polyposis (FAP) Colorectal Ovarian STK11 Mutant NSCLC Neuroblastoma Polyamine Dysregulation in Disease cology and autoimmune disease tumor growth, and modulatingthe immune system Au
Slide 6: Pipeline May Address Multiple Unmet Needs
Pipeline May Address Multiple Unmet Needs a PDA Neoadjuvant > Phase i Ready -Open 1H > Global Harmonization of Registration Protocol by 2 2023 > Futlity Analysis — 1H 2023 > Phase I NSCLC Open FPI — 142023 > Phase II NSCLC FPI 2H 2023 > Phase Il Enrolling > Indiana University / JDRF / Panbela Collab
Slide 7: Potential Market Opportunity for Lead Programs
Potential Market Opportunity for Lead Programs ana AL Metastatic Pancreatic Cancer ‘Target Population “32K in US ~133K in EU ~165K Approximately 70% patients are treated. Incidence of FAP ~30K In US 50K in EU ~80K 4 FAP Prevalencett/and ‘Target Population “15K in US ~20K in EU ~35K FAP Source: Burte
Slide 8: Complementary Pharmacotherapies Targeting Dysregulation
Complementary Pharmacotherapies Targeting Dysregulation Pipeline Objective Combined pipeline pharmacotherapies hit differenttargets in the polyamine pathway The objective of Panbela’s pipelineis the utilization of pharmacotherapiesto reduce/normalize increased disease- associated polyamines using co
Slide 9: Ivospemin (SBP-101)
lvospemin (SBP-101)
Slide 10: Preliminary Efficacy of ivospemin (SBP-101) + Gemcitabine/Nab-paclitaxel in First-Line Metastatic PDA
Preliminary Efficacy of ivospemin (SBP-101) + Gemcitabine/Nab-paclitaxel in First-Line Metastatic Pancreatic Ductal Adenocarcinoma BEST OVERALL RESPONSE Overall Disease PR ‘SD Response | Control Ivospemin (0.40 mg/kg) + G/A* (Ph la COHORT 2) 0 5 (71%) | 2 (29%) 0 5/7 (71%) | 5/7 (71%) n=7 ivospemin
Slide 11: Efficacy Comparison of ivospemin (SBP-101) + Gemcitabine/Nab-paclitaxel vs. Standard of Care
Efficacy Comparison of ivospemin (SBP-101) + Gemcitabine/Nab-paclitaxel vs. Standard of Care Treatment os PFS BP-101-03* 14.6 months | 6.5 months FOLFIRINOX? 1L.1months | 6.4months | 31.6% 70.2% 15.2% Modified FOLFIRINOX® 10.2months | 6.1months | 35.1% 86.5% 13.5% Pete ia Mt 12.6months | 9.2months 3
Slide 12: Ivospemin (SBP-101) + Gemcitabine/Nab-paclitaxel Overall Survival
Ivospemin (SBP-101) + Gemcitabine/Nab-paclitaxel Overall Survival* 100 canon ‘Cohort 4 + Phase 1b (0.40 mgikg) 90 ‘Survival Probability (%) Jat Risk 29 29 29 28 28 27 25 22 2 20 19 18 16 14 13:10 6 6 4 4 3 2 4 4 © 30 60 90 120 180 180 210 240 270 300 330 360 390 420 450 480 510 540 570 600 630 650 6
Slide 13: Ivospemin Demonstrated a Similar Safety Profile to Gemcitabine/Nab-paclitaxel
Ivospemin (SBP-101) + Gemcitabine/Nab-paclitaxel Demonstrated a Similar Safety Profile to Gemcitabine/Nab-paclitaxel in First-Line Metastatic Pancreatic Ductal Adenocarcinoma Safety Results Grade 23 AEs of Special Interest Paes Grade 23 adverse events attributable to any study medication, N=50. Hema
Slide 14: Phase III Pancreatic Cancer Trial in Subjects Previously Untreated for Metastatic PDA
Phase III Pancreatic Cancer Trial in Subjects Previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma ‘A Randomized, Double-Blind, Placebo Controlled Study of Nab-Paclitaxel and Gemcitabine with or Without ivospemin (SBP-101) Confirm eligibility enteria are met oT = Nab-paclitaxe! and G
Slide 15: Flynpovi: A Combination of CPP-1X and Sulindac
FLYNPOVI: A Combination of CPP-1X and Sulindac
Slide 16: Lead Product Opportunity — CPP-1X and Sulindac (Flynpovi)
Lead Product Opportunity — CPP-1X and Sulindac (Flynpovi) Familial Adenomatous Key Information: Polyposis (FAP) = No approved FAP drugs on the market = Agenetic disease = Target Physicians: Gastroenterologists caused by APC = US-only potential revenue at market share of 35%-60% mutations where colon
Slide 17: FAP-310 Trial: Time to Delay FAP-related Event Endpoint
FAP-310 Trial: “Time to Delay FAP-related Event” Endpoint CPP FAP 310 global study 150 Patients Required (171 Patients Enrolled) Randomization Two Years of Daily Treatment Time to delay FAP-related events ‘Composite Endpoint including surgeries, polyp removal, and upper Gl scoring system (“Spigelman
Slide 18: No Lower GI Surgeries for Flynpovi Combination
No Lower Gl Surgeries for Flynpovi Combination Event Rate Distribution of FAP-Related Surgery Events in Lower GI Sulindac Eflornithine ES Combo (N=56) Surgery Events (N=58) Need colectomy 3 4 Need proctectomy 1 1 Need pouch resection 4 1 Total Surgical Events 8 6 Event Rate 0/56 (0%) 8/57 (14%) 6/58
Slide 19: Flynpovi Combination Delays Need for Lower GI Surgery
Flynpovi Combination Delays Need for Lower GI Surgery ‘ett enn ome 0 = 2 I ER IM F a = Etlomithine Se a "i Wom Rann Oe FAP eae er (Moh ne oe oe oe oe oe oe oe El 2 s 4 8s 6 a E noo 4 6 6 nun 4 2 © Hazard Ratio (95% Ci) for having an Event Nominal P-Value &S ve Sulindac 0.000 (0.000, 483) tS vs Sulin
Slide 20: Rationale for Efficacy of Flynpovi in the Lower Gastrointestinal Tract of FAP Patients
Rationale for Efficacy of Flynpovi in the Lower Gastrointestinal Tract of FAP Patients Growth/Tissue Repair/Neoplasia —_ pita werss * Polyamines drive uncontrolled growth, polyposis, and cancer. * Polyaminescan by synthesized but also derived from the diet and microbiome. * The mechanism of disease
Slide 21: High Concentrations of the Microbiota Contribute to the Impact of Polyamines in the LGI
High Concentrations of the Microbiota Contribute to the Impact of Polyamines in The LGI » The microbiota increases steadily along the gastrointestinal A prextmat tract. ie beciand Small numbers in the stomach but very high # Stomach 10! itn ® concentrations in the colon. ie - Areas of the LGI contai
Slide 22: Adverse Events of Special Interest
| Adverse Events of Special Interest Flynpovi (Eflornithine + Sulindac Sulindac Eflornithine Adverse Events of Special Interest Combination) N=57 N=56 N=56 Subjects (%) Subjects (%) Subjects (%) 1 (1.8) 5 (8.8) 2 (3.6) 0 1 (1.8) 0 0 3 (5.3) 1 (1.8) | 1(1.8) 1 (1.8) 1 (1.8) 5 (8.9) 8 (14.0) 2 (3.6) 3
Slide 23: Basis for FDA Complete Response Letter
Basis for FDA Complete Response Letter = Clinical > Single pivotal study efficacy was based on exploratory post-hoc analysis using a modified primary endpoint in a subgroup of the intent-to treat population Asked to perform a new study focused on FAP patients with an intact lower- Gl tract which sho
Slide 24: Summary of Approach to Approval
| Summary of Approach to Approval Strong Results in the Lower GI v Focus on Lower GI: statistically significant p-values and hazard ratios for clinically meaningful surgical endpoints—emphasized by regulators—in Phase III pivotal trial Expected safety profile over 2-4 years of daily dosing in Phase
Slide 25: Polyamines & Immune Dysregulation
Polyamines & Immune Dysregulation
Slide 26: Role of Polyamines in Immune Dysregulation
Role of Polyamines in Immune Dysregulation = Immune systems require multiple soluble and cellular components, including polyamines, for anormal immune function = High levels of polyaminesare present in tumor cells and in autoreactive B- and T-cells in autoimmune diseases = Dysregulation of polyamine
Slide 27: Potential Role of Polyamines in Diffuse Large B Cell Lymphoma (DLBCL) CAR-T Therapy
Potential Role of Polyamines in Diffuse Large B Cell Lymphoma (DLBCL) CAR-T Therapy = Polyamine metabolism upregulation through oncogenic MYC is a common metabolic irregularity in aggressive cancers, including lymphomas. = MYC overexpression in relapsed/refractory DLBCL prior to CAR-T cell therapy n
Slide 28: Rationale for Eflornithine/anti-PD-1 Combination
Rationale for Eflornithine/anti-PD-1 Combination "= Targeting Ornithine decarboxylase (ODC) using eflornithine unmasks antitumor T cell immune response by weakening of tumor-induced immune suppression that is mediated by Myeloid- Derived Tumor Suppressor Cells (MDSCs). = The addition of anti-PD-1 pr
Slide 29: CPP-1X-S
CPP-1X-S
Slide 30: Rationale for CPP-1X-S (Eflornithine Sachets) in STK11 Mutant NSCLC
| Rationale for CPP-1X-S (Eflornithine Sachets) in STK11 Mutant NSCLC = In preclinical tumor models, eflornithine treatment improves anti-PD-1 efficacy by: > Increasing tumor-specific cytotoxic T-cell populations > Increasing expression of PD-1 on tumor-associated CD8+T cells = ~10% of NSCLC cancers
Slide 31: STK11 Mutant NSCLC Investigator-Initiated Trial
STK11 Mutant NSCLC Investigator-Initiated Trial Collaborating with investigators at Moffitt Cancer Center on Phase |/Il trial: “Targeting Ornithine Decarboxylase as an Immunotherapeutic Target in STK11 (LKB1) Pathway-Deficient Non-Small Cell Lung Cancer” Phase | Standard Pembro + CPP-1X-S Dose Escal
Slide 32: Business Overview
Business Overview
Slide 33: Barriers to Entry — Flynpovi/CPP-1X
Barriers to Entry — Flynpovi/CPP-1X » Orphan status (7 years exclusivity US; 10 years exclusivity EU) for CPP-1X Granted in US and EU for FAP Granted in US and EU for Neuroblastoma Granted in US for Gastric cancer and Pancreatic cancer » Pharmaceutical Composition Patent Fixed dose combination eflor
Slide 34: Barriers to Entry — ivospemin (SBP-101)
Barriers to Entry — ivospemin (SBP-101) » Orphan status (7 for years exclusivity US; 10 years exclusivity EU) for SPB-101 Granted in US and EU for pancreaticcancer » METHODS FOR PRODUCING (6S,15S)-3,8,13,18-TETRAAZAICOSANE-6,15-DIOL PCT application filed January 29, 2019 Granted in United States, In
Slide 35: Summary of Milestones
Summary of Milestones 1H 2023 Y Open. Phase | NSCLC Trial " Open- Neoadjuvant Pancreatic Cancer Trial ¥ Open ~ Phase ll Type | onset Diabetes Trial Futility Analysis Phase Ill Colon Cancer Risk Reduction Trial (PACES) tion of Phase | Type | early onset Diabetes Data + Publication of Final Phase | Me
Slide 36: Financial Position - Cash and Debt (unaudited)
| Financial Position - Cash and Debt (unaudited) Cash and Debt Cash at 3/31/2023 5,235,000 Estimated net proceeds from public offer closed on 6/21/23 7,600,000 Proforma cash balance 12,835,000 Debt at 3/31/2023 Current (due 1/31/2024) 1,000,000 Non-current 4,194,000 Total 5,194,000 (Proforma Cash co
Slide 37: Capital Stock (unaudited)
| Capital Stock (unaudited) Common Stock at 3/31/2023 535,507 Shares issued in exchange for warrants through 5/4/2023 23,250 Shares issued at closing of public offer on 6/21/2023 586,000 Shares to be issued at exercise of Prefunded warrants from 6/21/23 offer 1,684,000 Total Proforma Common stock ou
Slide 38: Summary
Summary: Unique Scientific Approach: Resetting dysregulation via polyamine pathway Broad, late-stage de-risked pipeline opportunities Multiple partnerships supporting development programs Significant market potential Multiple data readouts expected Experienced management team
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