Panbela Therapeutics, Inc. · OTC:PBLA
Panbela Therapeutics — Sun BioPharma — Investor Presentation (September 2020)
23 slides from Panbela Therapeutics's investor presentation, Sep 14, 2020
Slide 1: Company Overview September 2020
Company Overview September 2020 Jennifer K. Simpson, PhD President & CEO
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 inhibitor
Slide 4: Sun BioPharma Leadership Team and Board of Directors
Sun BioPharma Leadership Team and Board of Directors Collectively developed 10 FDA-approved therapies generating billions in sales Leadership Team Jennifer K. Simpson, PhD, MSN, CRNP President & CEO Michael T. Cullen, MD, MBA, ABIM Founder, Executive Chairman Susan Horvath, CPA (inactive), CMA VP of
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.) Lowest survival rate among major cancers 100% 98% 90% 80% 60% 65% 40% 21% 20% 10% 0% Prostate Breast Colorec
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 Ongoing P3 Approved P3 Discontinued P1 P3 Ongoing Immuno-Oncology Studies 70% 60% 50% 40% 30% 20% 10% 0% 54% +3
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 crea
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 production o
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, which is b
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 PDA (First Line Metastatic) PDA Neoadj
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) Days Post Tumor Implant Study in mice subcutaneously implanted with human pancreatic cell line PANC-1 SBP-101 found effective in reducing pancreatic tumor growth (1)
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 100 90 80 70 60 50 40 30 20 10 0 % Inhibition Gemcitabine + Nab-Paclitaxel SBP-101 Gemcitabine + Nab-Paclitaxel + SBP-101 A
Slide 13: SBP-101 Phase PDA Study Design Overview
SBP-101 Phase 1 PDA Study Design Overview Design Open-label P1A/1B study to assess safety, tolerability and PK when combined with Nab-Paclitaxel and Gemcitabine Identify P2 dose and schedule and assess preliminary efficacy of 3-drug treatment combination Primary Outcome Measure Safety, PK, Tolerabil
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 with
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 observed
Slide 16: Interim P1A CA 19-9 Positive Biomarker Data
Interim P1A CA 19-9 Positive Biomarker Data CA 19-9 tumor marker often released by pancreatic cancer cells Patients with CA 19-9 Decrease 88% 69% of subjects had a maximum CA 19-9 decrease greater than 75% 88% of subjects had a decrease in CA 19-9 levels 75% Decrease Maximum Percent Change from Base
Slide 17: SBP-101 Interim P1A Positive ORR Data
SBP-101 Interim P1A Positive ORR Data SBP-101 Well Tolerated in Combination with Gemcitabine and Nab-Paclitaxel Disease Control Rate(1) 100% (1) As measured by RECIST criteria (2) Cohorts 2 and 3 (interim results) 2.3x the response rate of Gemcitabine & Nab-Paclitaxel 2.0x the disease control rate o
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) Threshold for Progressive Disease (20% increase) Threshold for Partial Response (30% decrease)
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 neuropathy Grade 3
Slide 20: Capitalization
Capitalization Capitalization as of September 1, 2020 Common Shares Outstanding Stock Options @ $6.36 WAEP Warrants @ $5.31 WAEP Fully Diluted Shares Outstanding 9,649,427 2,170,459 6,564,326 18,384,212
Slide 21: Balance Sheet Summary and Use of Cash
Balance Sheet Summary and Use of Cash Balance Sheet Summary Cash at 6/30/2020 Term Loan(1) Unsecured Promissory Note(2) PPP Loan(3) Net Cash Balance at 6/30/2020(4) Estimated Net Proceeds on 9/1/2020 (5) Adjusted Net Cash Balance(4) Average Quarterly Cash used in Operations (6) $2,265,000 $68,000 $7
Slide 22: Milestones
Milestones 2020 Uplisted to Nasdaq (Q3'20) Completion of enrollment in the expansion cohort targeting (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)
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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