Panbela Therapeutics, Inc. · OTC:PBLA
Panbela Therapeutics — Investor Presentation (December 2020)
23 slides from Panbela Therapeutics's investor presentation, December 2020
Slide 1: Company Overview
Company Overview December 2020
Slide 2: Forward Looking Statements
Forward Looking Statements 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 s
Slide 3: Company Highlights
Company Highlights New Therapeutic Class For Solid Tumors ― Developing small molecule polyamine metabolic inhibitors with tumor and organ-specific preferential uptake ― Multiple cancer types with known elevated polyamine levels represent potential targets ― Novel Trojan Horse polyamine metabolic inh
Slide 4: Panbela Leadership Team and Board of Directors
Panbela Leadership Team and Board of Directors Collectively developed 10 FDA-approved therapies generating billions in sales Leadership Team Board of Directors Jennifer K. Simpson, PhD, MSN, CRNP Michael T. Cullen, MD, MBA, ABIM President & CEO Jennifer K. Simpson, PhD, MSN, CRNP Michael T. Cullen
Slide 5: Pancreatic Cancer: a Major Unmet Medical Need
Pancreatic Cancer: a Major Unmet Medical Need Globally, the number of deaths caused by, and incidence of, pancreatic cancer has more than doubled from 1990 to 2017 5-Year Survival Rate (U.S.) Deaths in the U.S. (Thousands) 100% 98% 160 90% Lowest survival rate 136 3rd leading cause 140 among major
Slide 6: Objective Response Rate Comparison Among Prior PDAC Trials
Objective Response Rate Comparison Among Prior PDAC Trials In addition to strong ORR results, 69% of SBP-101 patients presented CA 19-9 biomarker reductions of greater than 75% P1A Interim P3 P3 Ongoing Approved Discontinued 70% 70% 70% 60% 54% +31% 60% +16% 60% +7% 50% 50% 50% 40% 40% 40% 34% 23%
Slide 7: Increased Polyamine Levels Can Enhance the Malignant Potential of Cancer Cells
Increased Polyamine Levels Can Enhance the Malignant Potential of Cancer Cells and May Decrease Anti-Tumor Immunity Many tumors maintain greatly elevated levels of polyamines to support their rapid growth and survival ‒ Of all human tissues, the pancreas has the highest level of native spermidine
Slide 8: SBP-101 MOA (Trojan Horse): Synthetic Polyamine Analogue
SBP-101 MOA (Trojan Horse): Synthetic Polyamine Analogue SBP-101 is a synthetic analogue of spermine being designed to exploit the self-regulating nature of polyamine metabolism SBP-101 preferentially accumulates in tumor cells and downregulates the polyamine metabolic pathway, lowering producti
Slide 9: Area of Future Exploration: SBP-101 Combined with IOs
Area of Future Exploration: SBP-101 Combined with IOs Historical clinical trials using IO agents have been unsuccessful A potential hypothesis is that excess polyamines, especially spermine, insulate the tumor microenvironment from immune cells SBP-101 is a synthetic analogue of spermine, whic
Slide 10: Significant SBP-101 Polyamine Metabolic Inhibitor Pipeline Expansion Opportunity
Significant SBP-101 Polyamine Metabolic Inhibitor Pipeline Expansion Opportunity Upregulated polyamine metabolism is also a phenotypic change caused by certain oncogenic mutations, creating potential for future patient stratification strategies in other cancers Discovery Preclinical IND Ready Phase
Slide 11: SBP-101: Human Tumor Inhibition in Pre-Clinical Studies
SBP-101: Human Tumor Inhibition in Pre-Clinical Studies Near Complete Tumor Inhibition in Mice(1) Reduction of Tumor Volume in Mice(2) 1400 8,000 Untreated Control 7,199 1200 7,000 SBP-101 reduction in tumor volume vs. control SBP-101 15 mg/kg 6,000 and vs. Gemcitabine alone 1000 Mean Tumor Burden (
Slide 12: SBP-101 Shows Greater Inhibition of Human PDA Growth Than Standard of Care
SBP-101 Shows Greater Inhibition of Human PDA Growth Than Current Standard of Care (Gem + Nab) in an in vitro Study SBP-101 Demonstrates Superior and Additive Efficacy in vitro Gemcitabine + Nab-Paclitaxel SBP-101 Gemcitabine + Nab-Paclitaxel + SBP-101 100 90 80 70 60 % Inhibition 50 40 30 20 10 0 A
Slide 13: SBP-101 Phase 1 PDA Study Design
SBP-101 Phase 1 PDA Study Design Overview Design Open-label P1A/1B study to assess safety, tolerability and PK Dose Enrolled Dosing Schedule when combined with Nab-Paclitaxel and Gemcitabine Cohort 1 (n = 4) 0.2 mg/kg only Identify P2 dose and schedule and assess preliminary efficacy of 3-drug t
Slide 14: Clinical Importance of CA 19-9 Biomarker
Clinical Importance of CA 19-9 Biomarker Carbohydrate antigen (CA) 19-9 is a type of antigen found in the blood that is often elevated in pancreatic disease Studies have suggested that decreases in CA 19-9 levels are correlated with improved prognosis; ≥75% declines in CA 19-9 levels correlated
Slide 15: CA 19-9 Biomarker and Survival Benefit Correlation
CA 19-9 Biomarker and Survival Benefit Correlation Patients in the MPACT study (Phase III Gem+Nab) whose CA 19-9 levels decreased saw an approximate 5-month incremental median survival benefit (P=.001) compared to patients with unchanged or increased CA 19-9 levels Greatest survival benefit obse
Slide 16: Interim P1A CA 19-9 Positive Biomarker Data
Interim P1A CA 19-9 Positive Biomarker Data 69% of subjects had a maximum CA 19-9 decrease greater than 75% CA 19-9 tumor marker 88% of subjects had a decrease in CA 19-9 levels often released by 100% pancreatic cancer cells 80% 60% Maximum Percent Change from Baseline in CA19-9 Patients with 40
Slide 17: SBP-101 Interim P1A Positive ORR Data
SBP-101 Interim P1A Positive ORR Data 2.3x the response rate of Gemcitabine & Nab-Paclitaxel SBP-101 Well 2.0x the disease control rate of Gemcitabine & Nab-Paclitaxel Tolerated in Combination with 60% Gemcitabine and 54%(2) Nab-Paclitaxel 50% 2.3x Disease Control Rate(1) 40% Standard of Care 30
Slide 18: P1A Interim Response Rate by Patient
P1A Interim Response Rate by Patient N = 13 across Cohort 2 (0.4 mg/kg) and Cohort 3 (0.6 mg/kg) 54% partial response (7 of 13) 46% stable disease (6 of 13) Cohorts 2 and 3 – 54% Objective Response Rate(1) 20% Threshold for Progressive Disease (20% increase) % Change in Sum of RECIST Measureme
Slide 19: Interim P1A Results
Interim P1A Results Gemcitabine (G, Gemzar, Eli Lilly) & Nab-Paclitaxel (A, Abraxane, Celgene): Standard pancreatic cancer Rx combination Grade 3-4 neutropenia 38% Grade 3-4 thrombocytopenia 13% Grade 3-4 peripheral neuropathy 17% SBP-101 No added neutropenia, thrombocytopenia, or neur
Slide 20: Capitalization
Capitalization Capitalization Table Common Shares Outstanding 9,649,427 Stock Options @ $6.71 WAEP 2,170,459 Warrants @ $5.31 WAEP 6,571,468 Fully Diluted Shares Outstanding 18,391,354 Panbela Therapeutics 20
Slide 21: Balance Sheet Summary and Use of Cash
Balance Sheet Summary and Use of Cash Balance Sheet Cash at 9/30/2020 $10,870,000 Term Loan(1) $39,000 Promissory Note(2) $742,000 PPP Loan(3) $103,000 Net Cash at 9/30/2020 $9,986,000 Average Quarterly Cash Used in Operations(4) $1,000,000 (1) Annual interest 4.125%, matures 12/31/2020, recurring m
Slide 22: Milestones
Milestones 2020 ► Uplisted to Nasdaq (Q3'20) ► Completed enrollment in the expansion cohort (Q4'20) 2021 ► Data from phase 1 trial (1H'21) ► Conference presentation (1H'21 or 2H'21) ► Initiation of randomized phase 2 study (1H'21) Panbela Therapeutics 22
Slide 23: SBP-101 Summary
SBP-101 Summary Unique dual-attack MOA is synergistic with other agents, potentially enhancing anti-tumor response Favorable safety & tolerability profile and subcutaneous administration in clinical studies to date supports potential ease of use Encouraging interim efficacy and tumor marker signals
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