Aprea Therapeutics, Inc. · NASDAQ:APRE
Aprea Therapeutics — J.P. Morgan 40th Annual Healthcare Conference January 2022
23 slides from Aprea Therapeutics's conference presentation, Jan 13, 2022
Slide 1: J.P. Morgan 40th Annual Healthcare Conference January 2022
J.P. Morgan 40 th Annual Healthcare Conference January 2022
Slide 2: Forward-Looking Statements
Forward - Looking Statements Certain information contained in this presentation includes “forward - looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, related to our clinical trials, re
Slide 3: Presentation Overview
Presentation Overview ▪ 2021 Year in Review ◊ MDS Phase 3 study v. Phase 2 ◊ Undertreatment in experimental arm negatively impacted efficacy in the Phase 3 study ◊ Phase 3 study design complicated results ◊ FDA interaction ▪ FDA Clinical Holds ◊ Lymphoid malignancies full clinical hold lifted ◊ Myel
Slide 4: Multiple Pathways to Induce Antitumor Activity
Multiple Pathways to Induce Antitumor Activity © 2022 Aprea Therapeutics. All Rights Reserved. 4 Eprenetapopt and APR - "next gen" p53 Reactivation Oxidative stress & Ferroptosis Antitumor Activity Immune Modulation
Slide 5: 2021 Review
2021 Review © 2022 Aprea Therapeutics. All Rights Reserved. 5
Slide 6: Efficacy Results from Phase 3 vs Phase 2 Trials
Efficacy Results from Phase 3 vs Phase 2 Trials Top - line Phase 3 data released December 2020 ▪ Phase 3 trial failed to meet CR primary endpoint in ITT population at LPI + 6 data cutoff ◊ 53% more patients achieved CR in eprenetapopt + AZA arm ◊ Primary CR endpoint missed p - value < 0.05 by a tota
Slide 7: Observations between Phase 3 vs Phase 2 Clinical Studies
Observations between Phase 3 vs Phase 2 Clinical Studies ▪ Study Demography: Phase 3 vs. Phase 2 ◊ Similar baseline disease characteristics (though higher proportion of higher risk patients in Phase 3 experimental arm) ◊ Similar patient profile of TP53 and non - TP53 mutations ▪ Clinical Observation
Slide 8: Conclusions and Next Steps
Conclusions and Next Steps ▪ Phase 3 Clinical Study Review ◊ Response rate data encouraging despite topline miss ◊ Study results impacted by study design and execution ◊ Near miss on end - point: larger study? ◊ Un - blinded study design may have resulted in treatment and selection bias ◊ How much d
Slide 9: Clinical Hold Update
Clinical Hold Update 9 © 2022 Aprea Therapeutics. All Rights Reserved.
Slide 10: Myeloid Malignancies Clinical Hold
Myeloid Malignancies Phase 3 Frontline MDS, Phase 2 AML, Phase 2 Post - Transplant MDS/AML ▪ FDA Partial Clinical Hold – Summary information requests ◊ Review and analyze safety database for infections, by dose levels ◊ Provide SAE listings and patient narratives, by dose levels ◊ Develop strategy f
Slide 11: Lymphoid Malignancies Clinical Hold
Lymphoid Malignancies Phase 1 Relapsed/Refractory CLL/MCL ▪ FDA Clinical Hold – Summary information requests ◊ Explore optimal dose in dose - escalation design ▪ Phase 1 study had enrolled 1 patient ◊ Patient achieved CR ▪ FDA interaction October 2021 ◊ Submission included proposed amendments for cl
Slide 12: 2022 Development Strategy
2022 Development Strategy © 2022 Aprea Therapeutics. All Rights Reserved. 12
Slide 13: ASH 2021 Oral Presentation: Post-HCT Maintenance Phase II Trial
ASH 2021 Oral Presentation © 2022 Aprea Therapeutics. All Rights Reserved. 13 Phase II Trial of Eprenetapopt (APR - 246) in Combination with Azacitidine (AZA) As Maintenance Therapy for TP53 Mutated AML or MDS Following Allogeneic Hematopoietic Stem Cell Transplantation (HCT) 1 Department of Blood a
Slide 14: Outcomes from Post-HCT Maintenance Study Compare Favorably to Historical Data
Outcomes from Post - HCT Maintenance Study of Eprenetapopt with Aza Compare Favorably to Historical Data ▪ Data suggest Post - HCT maintenance therapy with eprenetapopt and AZA was safe and tolerable ◊ Majority of AEs comprised known complications in the post - HCT period ◊ 13 participants (42%) com
Slide 15: Eprenetapopt + AZA vs Control in Post-HCT Maintenance
Eprenetapopt + AZA vs Control in TP53 Mutant MDS/AML Post - HCT Maintenance © 2022 Aprea Therapeutics. All Rights Reserved. 15 ▪ Encouraging 1 - yr RFS, 1 - yr OS, median RFS, and median OS observed in patients with TP53 mutant MDS/AML who received post - HCT maintenance with eprenetapopt + AZA comp
Slide 16: Clinical Development Plan in TP53 Mutant Myeloid Malignancies
Clinical Development Plan in TP53 Mutant Myeloid Malignancies Pending Final FDA approval ▪ Overview of Phase 1 Trial in R/R TP53 mutant MDS/AML to assess 3 dose levels to determine optimal dose of eprenetapopt (N=up to 30) ▪ Status ◊ Plan first patient enrolled Q2 2022 ◊ Preliminary tolerability and
Slide 17: Phase 1 Trial in R/R TP53 Mutant Richter's Transformed NHL
Phase 1 Trial of Eprenetapopt Combination Therapy in R/R TP53 Mutant Richter’s Transformed NHL ▪ In large cancer cell databases, lymphoid cancer cell lines appear to be among the most sensitive to eprenetapopt 1 . ▪ Overview of Phase 1 Trial in R/R Richter’s Transformed NHL (N=up to 30) ▪ Introduce
Slide 18: Phase 1/2 Eprenetapopt + Pembrolizumab in Advanced Solid Tumors
Phase 1/2 Trial of Eprenetapopt + Pembrolizumab Combination in Advanced Solid Tumors ▪ Overview of Phase 1/2 Solid Tumor Trial ▪ Program update ◊ No dose limiting toxicities in lead - in phase (N=6) ◊ Enrollment completed, with 6 patients enrolled to gastric, 5 to bladder arm and 20 to NSCLC ◊ Prese
Slide 19: New Generation APR Molecules
New Generation APR molecules APR - 548 & APR - 3rd generation ▪ Overview of APR - 548 FIH Trial ▪ APR - 548: Status ◊ 3 patients enrolled ◊ Expect to stop enrollment up to ~10 patients ◊ Provides opportunity to collect blood and bone marrow samples to study pharmacodynamics ▪ APR – 3 rd Generation ◊
Slide 20: 2022 Corporate Strategy
2022 Corporate Strategy © 2022 Aprea Therapeutics. All Rights Reserved. 20
Slide 21: Identify New Assets & Opportunities
Identify New Assets & Opportunities ▪ Capitalize on Scientific and Development Expertise ◊ Knowledge of disease processes and therapeutic targets/pathways, including ◊ DNA damage ◊ Cell cycle control ◊ Oxidative stress ◊ Apoptosis and Ferroptosis ◊ Clinical Development ◊ Clinical operations ◊ Clinic
Slide 22: 2022 Financial and Planned Clinical Milestones
2022 Financial and Planned Clinical Milestones ▪ Financial ◊ $50 - 55 million of cash and cash equivalents (unaudited) expected at December 31, 2021 ◊ Anticipated cash burn for 2022: $25 – 30 million ◊ Existing cash should fund operations into 2023 ◊ Exploring new assets and opportunities ▪ 2022 Pla
Slide 23: J.P. Morgan 40th Annual Healthcare Conference January 2022
J.P. Morgan 40 th Annual Healthcare Conference January 2022
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