Aprea Therapeutics, Inc. · NASDAQ:APRE
Aprea Therapeutics — J.P. Morgan 39th Annual Healthcare Conference 2021
20 slides from Aprea Therapeutics's conference presentation, Jan 12, 2021
Slide 1: J.P. Morgan 39th Annual Healthcare Conference January 2021
J.P. Morgan 39 th Annual Healthcare Conference January 2021
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 and
Slide 3: Aprea Therapeutics and Presentation Agenda
Aprea Therapeutics ▪ The global leader in p53 - targeted therapies for the treatment of cancer ◊ Proof - of - concept and proof - of - principle demonstration of mutant p53 reactivation Presentation Agenda ▪ Update on Phase 3 MDS Clinical Study ▪ Development Pipeline ◊ 1L AML ◊ Post - transplant mai
Slide 4: p53: The Guardian of the Genome
p53: The “Guardian of the Genome” © 2021 Aprea Therapeutics. All Rights Reserved 4 p 53 tumor suppressor The nexus and regulator of key anti - cancer network of signals • Triggers cell cycle arrest and apoptosis in response to DNA damage and other cellular stresses The most frequently mutated gene i
Slide 5: Reactivation of Mutant p53 Across Mutation Types
Reactivation of Mutant p53 Across Mutation Types ▪ p53 protein destabilization is a general and direct consequence of mutation ▪ Eprenetapopt MoA is agnostic to specific p53 mutation, capitalizes on principles of protein folding & stability ◊ Activity observed in nearly 100 different p53 mutations i
Slide 6: Clinical Development
Clinical Development © 2021 Aprea Therapeutics. All Rights Reserved 6
Slide 7: Execution on Clinical Development
Molecule Indication Preclinical Phase 1 Phase 2 Phase 3 Eprenetapopt (APR - 246) 1L TP53 Mutant MDS 1 1L TP53 Mutant MDS and AML (U.S. study) 2 1L TP53 Mutant MDS and AML (French study) 2 TP53 Mutant MDS and AML Post - Transplant Maintenance 1L and R/R TP53 Mutant AML R/R TP53 Mutant CLL and MCL Adv
Slide 8: Phase 3 MDS Review
Phase 3 MDS Review © 2021 Aprea Therapeutics. All Rights Reserved 8
Slide 9: Randomized Phase 3 Trial in 1L TP53 Mutant MDS
Randomized Phase 3 Trial in 1L TP53 Mutant MDS Trial design © 2021 Aprea Therapeutics. All Rights Reserved 9 1:1 Randomization Eprenetapopt + AZA AZA Patients • N = 154 • At least one TP53 mutation • Int/High/Very High IPSS - R • ECOG performance status of 0, 1 or 2 • De novo and secondary MDS eligi
Slide 10: Recap of Results from Phase 3 Trial in TP53 Mutant MDS
Recap of Results from Phase 3 Trial in TP53 Mutant MDS ▪ Primary data cut (LPI + 6 months) ◊ Failed to meet CR primary endpoint in ITT population ◊ 33.3% in eprenetapopt + AZA arm vs. 22.4% in AZA alone arm (P = 0.13) ◊ Primary endpoint did not reach statistical significance ◊ CR rate was 53% higher
Slide 11: Pipeline
Pipeline © 2021 Aprea Therapeutics. All Rights Reserved 11
Slide 12: TP53 Mutant AML is a Major Unmet Medical Need
TP53 Mutant AML is a Major Unmet Medical Need with Limited Treatment Options © 2021 Aprea Therapeutics. All Rights Reserved 12 Global Data, “Acute Myeloid Leukemia Forecast to 2029” 20 - 30% TP53 mutant 45,000 in 2019 in US/EU5/JP 0 - 20% complete remission (CR) ~6 months overall survival (OS) Incid
Slide 13: 1L TP53 Mutant AML Trial
1L TP53 Mutant AML Trial ▪ Current Eprenetapopt Data and Therapeutic Benchmark ▪ Phase 1/2 AML Trial Plan © 2021 Aprea Therapeutics. All Rights Reserved 13 1 Phase 1/2 AML Trial as of December 31, 2020; 2 Dinardo et al, EHA 2020; Dinardo et al, N Engl J Med 2020; 383:617 - 629; 3 Patients who have u
Slide 14: Post-Transplant Maintenance Therapy in TP53 Mutant MDS and AML
Post - Transplant Maintenance Therapy in TP53 Mutant MDS and AML Unmet Need ▪ Allo - HCT is currently the only potentially curative option for TP53 mutant MDS/AML, however only 5 - 10% of patients are able to undergo transplantation ▪ Prognosis remains poor even in patients who undergo transplantati
Slide 15: Eprenetapopt Combination in R/R Lymphoid Malignancies
Eprenetapopt Combination in R/R Lymphoid Malignancies Unmet Need ▪ There is a lack of effective treatments for R/R TP53 mutant CLL and MCL Rationale ▪ Preclinical data demonstrating synergistic activity of eprenetapopt + venetoclax, eprenetapopt + ibrutinib ▪ Encouraging clinical data in CLL from fi
Slide 16: Eprenetapopt Combination in Advanced Solid Tumors
Eprenetapopt Combination in Advanced Solid Tumors Unmet Need Rationale ◊ APR - 246 enhances effects of PD - 1 blockade in murine melanoma and colorectal carcinoma models ◊ APR - 246 induces pro - inflammatory tumor microenvironment and activity driven by tumor associated macrophages Development Stat
Slide 17: APR-548: Next-Generation Oral p53 Reactivator
APR - 548: Next - Generation Oral p53 Reactivator ▪ APR - 548 is converted to MQ, shares a similar mechanism of action to eprenetapopt ◊ High oral bioavailability supportive of oral administration ◊ Greater potency than eprenetapopt in preclinical studies ◊ Faster conversion to MQ may provide for hi
Slide 18: First-in-Human Clinical Trial of APR-548 in TP53 Mutant MDS
First - in - Human Clinical Trial of APR - 548 in TP53 Mutant MDS IND and protocol have been accepted by FDA ▪ Overview of FIH Trial ◊ Provides opportunity to collect blood and bone marrow samples to study pharmacodynamics ▪ Status ◊ FPI anticipated Q1 2021 ▪ Following completion of FIH Phase 1, pos
Slide 19: Financial and Operational Highlights
Financial and Operational Highlights ▪ Financial ◊ $89.0 million of cash and cash equivalents (unaudited) at December 31, 2020 ◊ No outstanding debt ◊ Anticipated cash burn for 2021: $30 – 35 million ◊ Existing cash should fund operations into 2023 ◊ Consider strategic alternatives ▪ Operational ◊ 1
Slide 20: 2021 Anticipated Milestones
2021 Anticipated Milestones Milestones Timeline Phase 2 MDS / AML post - transplant maintenance Primary endpoint readout 2Q 2021 Phase 1/2 AML Trial Tolerability and efficacy data from cohort expansion 2Q 2021 Phase 1 NHL Trial Preliminary tolerability and efficacy data 2H 2021 Phase 1/2 Solid Tumor
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