Panbela Therapeutics, Inc. · OTC:PBLA
Panbela Therapeutics — Merger or Acquisition (June 2022)
35 slides from Panbela Therapeutics's merger presentation, Jun 22, 2022
Slide 1: CombinedCo Investor Presentation June 2022
CombinedCo Investor Presentation June 2022 Lastmodified on 6/22/22 Panel Therapeties
Slide 2: Disclaimers
Disclaimers Certain statements inthis 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 ba
Slide 3: Combined Company Presents A Unique Opportunity: Multi-Targeted Approach to Reset Dysregulated Biology
Combined 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 e "Our drug targeting strategies may allow for product opportunities in therapeutic areas of high unme
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 5 Dr. Jennifer Simpson Sue Horvath Dr. Thomas Neenan Rachel Bragg Chief Executive Oficer Chief Financial Officer Chief Scientific Officer VF dinical Deve
Slide 5: Dysregulation of the Polyamine Pathway Leads to Disease
| Dysregulation of the Polyamine Pathway Leads to Disease Polyamine Dysregulation in Disease Cancer " r Pancreatic Autoimmune Diseases Familial Adenomatous Polyposis (FAP) Recent Onset Type 1 Diabetes Colorectal Ovarian ‘STK11 Mutant NSCLC Neuroblastoma Initial focus on oni nhancing anti-tumor a tum
Slide 6: Combined Pipeline May Address Unmet Needs
Combined Pipeline May Address Unmet Needs > ally funded by fcensing partner > F134 2023 > utity Analysis End of 202 PDA (First Line Metastatic) > ime ngage ‘Analysis 1 2024 PDA Neoadjuvant > Phase Ready - Open 2H 2022 Ovarian > Phase 1 Ready - Open Mid 2022 > Phase Ready FP1~2H 2022 > Phase 1 FP1—2H
Slide 7: Potential Market Opportunity for Lead Programs
| Potential Market Opportunity for Lead Programs | = | ] _rentecner | Sneed Incidence of Incidence of Incidence of Incidence of FAP AL Metastatic Pancreatic Cancer Colorectalancer ‘Ovarian cancer 20K inus. s7kinus 150K in US “2K inus. “Sox ingU 190K In EU 240K In EU “79K in€U. ~80K* ~247K ~A90K ~101
Slide 8: Complementary Pharmacotherapies Targeting Dysregulation
| Complementary Pharmacotherapies Targeting Dysregulation Pipeline Objective The objective of Panbela’s pipelineis the utilization of pharmacotherapiesto reduce/normalize increased disease- associated polyamines using complementary pharmacotherapies Spemisreiperre sceiomnseme Ponte Combined pipeline
Slide 9: FLYNPOVI: A combination of CPP-1X and Sulindac
FLYNPOVI: A combination of CPP-1X and Sulindac
Slide 10: Lead Product Opportunity — CPP-1X and Sulindac (Flynpovi)
Lead Product Opportunity — CPP-1X and Sulindac (Flynpovi) 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 (approximately 11,300-18,4
Slide 11: 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) 2:1:1 Randomization ‘Two Years of Daily Treatment Time to delay FAP-related events Composite Endpoint including surg yp removal, and ‘upper GI scoring system ("Spigel sed
Slide 12: 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 Surgery Events ES Combo Eflornithine | sulindac Overall (N=56) (N=57) (N=58) (N=171) Need colectomy 0) 3) 4 7 Need proctectomy CY) 1 1 2 Need pouch resection 0) 4 1 5 Total Surgical Event
Slide 13: Flynpovi Combination Delays Need for Lower GI Surgery
| Flynpovi Combination Delays Need for Lower GI Surgery seine * Etiornithine 2 o6 @ = 2 ow @ rinetomfanmantonduto FAP os : iH s 4 os mm ms 3 un 6 i Peja pots emer farsa been fs Hazard atio(25% G) for havingan Event NominalP-Vale Svs Sulindat=0.00 (0.000, 0483) ES vs sulindae=0.0088 £S vtElomthine=0.
Slide 14: 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 rT. cron roth aus + Polyamines drive uncontrolled growth, polyposis, and cancer. + Polyaminescan by synthesized but also derived from the diet and microbiome. + The mechanism of disease driven by polyamines which
Slide 15: 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 print tract. on ‘Small numbers in the stomach but very high ae concentrationsin the colon. iy ° Areas of the LGI contain up to nine orders of magni
Slide 16: Adverse Events of Special Interest
| Adverse Events of Special Interest Flynpovi (Eflornithine + Sulindac Sulindac Eflornithine Adverse Events of Special Interest Combination) N=57 6 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) 33 (
Slide 17: 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 o Asked to perform a new study focused on FAP patients with an intact lower- Gl tract which s
Slide 18: Moving Ahead: New Phase III Trial
| Moving Ahead: New Phase III Trial Moving Ahead 2022 = North America Licensee funding next trial = FDA and EMA focus on new Phase Ill trial : > Lower Gl focus (LGI), informed by positive data from FAP-310 and regulatory feedback > Reaffirm current clarity & acceptable aspects of CMC, clin pharm, an
Slide 19: Summary of Approach to Approval
| Summary of Approach to Approval Strong Results in the Lower GI v Focus on Lower Gl: 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 20: SBP-101
SBP-101
Slide 21: Preliminary Efficacy of SBP-101 + Gemcitabine/Nab-paclitaxel in First-Line Metastatic PDAC
Preliminary Efficacy of SBP-101 + Gemcitabine/Nab-paclitaxel in First-Line Metastatic Pancreatic Ductal Adenocarcinoma BEST OVERALL RESPONSE n=431, Overall Disease CR PR SD PD Response | Control ‘SBP-101 (0.40 mg/kg) + G/A* (Phia COHORT 2) i) 5 (71%) 2 (29%) i) 5/7 (71%) | 5/7 (71%) n=7 ‘SBP-101 (0.
Slide 22: Efficacy Comparison
Efficacy Comparison n te P ORR D PD CL-SBP-101-03! 14.6 months | 6.5months | 48.3% 82.8% 4.8% FOLFIRINOX? 11.1 months | 64months | 31.6% 70.2% 15.2% Modified FOLFIRINOX® 10.2 months | 6.1months | 35.1% 86.5% 13.5% Gemeitabine +Abraxane | 12 months | 7.9 months 48% 68% 16% Phase 1/2 ‘Gemcitabine +Abr
Slide 23: SBP-101 + Gemcitabine/Nab-paclitaxel Overall Survival
| SBP-101 + Gemcitabine/Nab-paclitaxel Overall Survival* 7 Cohort 2 N=7: 2 patients with long term survival. + One still alive at 33.1 months + One deceased at 30.3 months Cohort 4+1b = 6 patients still alive * ona metosnces
Slide 24: SBP-101 + Gemcitabine/Nab-paclitaxel Demonstrated a Similar Safety Profile
SBP-101 + Gemcitabine/Nab-paclitaxel Demonstrated a Similar Safety Profile to Gemcitabine/Nab-paclitaxel in First-Line Metastatic Pancreatic Ductal Adenocarcinoma Safety Results Grade23 AEs of Special interest N cor Grade 23 adverse events attributable to any study medication, N=50. Hematologic Even
Slide 25: Phase II/III Pancreatic Cancer Trial Initiated 1Q 2022
Phase II/IIl Pancreatic Cancer Trial Initiated 1Q 2022 in Subjects Previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma ARandomized, Double-Blind, Placebo Controlled Study of Nab-Paclitaxel and Gemcitabine with or Without SBP-101 (sem Tipe Arm Conta Ar ‘Sor-iors Presto Nab paca and G
Slide 26: Polyamines & Immune Dysregulation
Polyamines & Immune Dysregulation
Slide 27: Role of Polyamines in Immune Dysregulation
| Role of Polyamines in Immune Dysregulation = Immune systems require multiple soluble and cellular components, including polyamines, for a normal immune function * High levels of polyaminesare present in tumor cells and in autoreactive B- and T-cells in autoimmune diseases = Dysregulation of polyam
Slide 28: Rationale for Eflornithine/anti-PD-1 Combination
| Rationale for Eflornithine/anti-PD-1 Combination MeaiieatemTarsaltale20¢aneta ornithine/antt-90-1 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 Suppress
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 p Esc
Slide 32: Business Overview
Business Overview
Slide 33: Summary of Upcoming Milestones
| Summary of Upcoming Milestones a 2022 ASCO Gl Poster Presentation ~ Interim Phase | 1L mPC = Close Transaction = FPI—Randomized Phase II/Ill 1L Metastatic Pancreatic Cancer Trial (mPC) = Final Data— Phase | 1L mPC = Initiation of Ovarian Cancer Clinical Program = FAP Global Registration Trial (spo
Slide 34: Proforma Financial Position and Capital
Proforma Financial Position and Capital UNAUDITED Cash at 3/31/22 7,386,000, Common Stock at 3/31/22 13,449,117 Shares reserved for Options (WAE = $5.76) 2,449,531 Shares reserved for Warrants (WAE = 4.59) 5,109,501 Total Outstanding and Reserved 21,008,149 Cash at 3/31/22 215,000 Proforma Combined
Slide 35: Summary: Combination of PBLA and CPP
Summary: Combination of PBLA and CPP Unique Scientific Approach: Resetting dysregulation via polyamine pathway Multiple targets and products in the pipeline Broad, late-stage pipeline opportunities Multiple data readouts expected Experienced management team Significant market potential
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