Aprea Therapeutics, Inc. · NASDAQ:APRE
Aprea Therapeutics — Investor Presentation (September 2023)
27 slides from Aprea Therapeutics's investor presentation, Sep 11, 2023
Slide 1: Precision Oncology Through Synthetic Lethality
Precision Oncology Through Synthetic Lethality September 2023
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, regula
Slide 3: Precision Oncology via Synthetic Lethality in Defined Patient Populations
© 2023 Aprea Therapeutics, Inc. All Rights Reserved. 3 Precision Oncology via Synthetic Lethality in Defined Patient Populations ▪ Clinical stage precision medicine through developing novel synthetic lethality (SL) - based therapeutics ▪ All programs addressing significant unmet medical need ▪ ATR I
Slide 4: Precision Oncology via Synthetic Lethality in Defined Patient Populations
© 2023 Aprea Therapeutics, Inc. All Rights Reserved. 4 Precision Oncology via Synthetic Lethality in Defined Patient Populations ▪ WEE1 Inhibitor: ATRN-1051 ◊ IND enabling studies ◊ Anticipate submitting an IND by the end of 2023 ◊ Pre-clinical proof-of-principle ◊ Demonstrated anti-tumor activity ◊
Slide 5: Experienced Leadership
Experienced Leadership © 2023 Aprea Therapeutics, Inc. All Rights Reserved. 5 Management Board of Directors Richard Peters, M.D., Ph.D. Chairman of the Board Oren Gilad, Ph.D. President and CEO Jean-Pierre Bizzari, M.D. Director Marc Duey Director Michael Grissinger Director Gabriela Gruia, M.D. Dir
Slide 6: WEE1 Inhibitor: ATRN-1051
WEE1 Inhibitor : ATRN-1051 Pre-clinical proof-of-principle 6 © 2023 Aprea Therapeutics, Inc. All Rights Reserved.
Slide 7: Press Release announcing advancement of Lead WEE1 Inhibitor ATRN-1051
© 2023 Aprea Therapeutics, Inc. All Rights Reserved. 7 Aprea Press Release announcing the advancement of Lead WEE1 Inhibitor, ATRN-1051 September 11, 2023 Aprea Announces Preclinical Data Supporting Highly Differentiated WEE1 Inhibitor, ATRN-1051, Relative To Other WEE1 Inhibitors Demonstrating pote
Slide 8: WEE1 Inhibitor - ATRN-1051 Mechanism of Action
WEE1 Inhibitor - ATRN-1051 Mechanism of Action © 2023 Aprea Therapeutics, Inc. All Rights Reserved. 8 …and triggers mitotic catastrophe and cancer cell death ATRN-1051 binds to WEE1 …inhibits its biological activity… Mitotic catastrophe + cancer cell death WEE1 active ATRN-1051 WEE1 inactive CDK1 ac
Slide 9: ATRN-1051 Has Demonstrated Potentially Compelling Anti-tumor Activity
ATRN-1051 Has Demonstrated Potentially Compelling Anti-tumor Activity IND filing targeted by the end of 2023 © 2023 Aprea Therapeutics, Inc. All Rights Reserved. 9 Pre-clinical studies with ATRN-1051 N=7 mice per group, ATRN-1051, exploratory formulation - 30 mg/kg/day Data on file
Slide 10: Potential Differentiation WEE1 Inhibitor: ATRN-1051
Potential Differentiation © 2023 Aprea Therapeutics, Inc. All Rights Reserved. 10 WEE1 Inhibitor : ATRN-1051
Slide 11: ATRN-1051 is Potentially Differentiated from Other WEE1 Inhibitors
ATRN-1051 is Potentially Differentiated from Other WEE1 Inhibitors © 2023 Aprea Therapeutics, Inc. All Rights Reserved. 11 ATRN-1051 shows potential to be potent and structurally differentiated, with high selectivity to limit off-target toxicity Note: Head-to-head studies have not been conducted (1)
Slide 12: ATRN-1051 Preclinical Data Highlight Potentially Favorable PK Properties
© 2023 Aprea Therapeutics, Inc. All Rights Reserved. 12 ATRN-1051 Preclinical Data Highlight Potentially Favorable PK Properties Note: Head-to-head studies have not been conducted (1) Data from an exploratory formulation of ATRN-1051 administered to fasted Balb/c mice (2) Data from study in A-427 NS
Slide 13: ATRN-1051 2023-2025 Anticipated Preclinical and Clinical Milestones
ATRN-1051 2023-2025 Anticipated Preclinical and Clinical Milestones Milestone Timeline Pre-clinical proof-of-principle Additional differentiation data 4Q 2023 IND Submission Clearance 4Q 2023 1Q 2024 Phase 1/2a – Monotherapy Dose Escalation First Patient Enrolled 1H 2024 Last Patient Enrolled 2H 202
Slide 14: ATR Inhibitor: ATRN-119
ATR Inhibitor : ATRN-119 Pre-clinical proof-of-principle © 2023 Aprea Therapeutics, Inc. All Rights Reserved Confidential. 14
Slide 15: ATR Inhibitor - ATRN-119 Mechanism of Action
ATR Inhibitor - ATRN-119 Mechanism of Action © 2023 Aprea Therapeutics, Inc. All Rights Reserved. 15 …and triggers replication fork collapse and Double Strand Breaks ATRN-119 binds to ATR …inhibits its biological activity… Replication fork collapse + Double Strand Breaks NT NT 125 62 32 16 8 4 2 1 p
Slide 16: ATRN-119 Preclinical Profile
▪ Nanomolar potency in vitro across a broad spectrum of cancer cell lines ▪ Based on pre-clinical studies, strong tumor control observed in vivo, including in challenging genetic backgrounds © 2023 Aprea Therapeutics, Inc. All Rights Reserved. 16 Pre-clinical studies with ATRN-119 and ATRN-157 ATRN-
Slide 17: ATRN-119 + Olaparib: Regression of BRCA2-Deficient Ovarian Tumors
ATRN-119 + Olaparib: Regression of BRCA2-Deficient Ovarian (HGSOC) Tumors 17 ATRN-119 + Olaparib Inhibits Ovarian Tumor Growth Over Time ATRN-119 + Olaparib Shows Negligible Weight Loss Over Time © 2023 Aprea Therapeutics, Inc. All Rights Reserved. Pre-clinical studies with ATRN-119 N=6-8 mice per g
Slide 18: Potential Differentiation ATR Inhibitor: ATRN-119
Potential Differentiation © 2023 Aprea Therapeutics, Inc. All Rights Reserved. 18 ATR Inhibitor : ATRN-119
Slide 19: Comparison of ATR inhibitors
19 Parameter AstraZeneca AZD6738 (1)(2) Bayer BAY1895344 (3) Repare / Roche(4) RP-3500 (5) Route Of Administration Oral Oral Oral Clinical Studies Chosen (MTD/RP2D), Dose Schedule 160mg BID, 2-weeks-on, 2-weeks-off, or: Continuous dosing (1) 40mg BID, 3-days-on/4-days-off 160mg QD, 3-days-on/4-days-
Slide 20: ATRN-119 Daily Dosing Is Desirable
ATRN-119 Daily Dosing Is Desirable Lack of daily dosing may contribute to formation of resistance © 2023 Aprea Therapeutics, Inc. All Rights Reserved. 20 Tumor reduction and regrowth Drug “On” Drug “Off” Drug “On” Continuous tumor reduction
Slide 21: ATRN-119 dosing and tolerability profile
21 Parameter ATRN-119 (1) Route Of Administration Oral Clinical Studies Chosen (MTD/RP2D), Dose Schedule continuous once-daily dosing (dose TBD in Phase 1) (1) Hematological toxicities in preclinical studies Pre-Clinical, Toxicology Studies: • In 28-day GLP tox study in dogs, hematological changes w
Slide 22: Phase 1/2a - AR-276-01 - Study Overview
© 2023 Aprea Therapeutics, Inc. All Rights Reserved. 22 Phase 1/2a - AR-276-01 - Study Overview AR-276-01: A PHASE 1/2a, OPEN-LABEL, SAFETY, PHARMACOKINETIC, AND PRELIMINARY EFFICACY STUDY OF ORAL ATRN-119 IN PATIENTS WITH ADVANCED SOLID TUMORS Sites: 4 US sites for dose escalation ❖ University of P
Slide 23: Phase 1/2a - AR-276-01 - Study Overview (continued)
© 2023 Aprea Therapeutics, Inc. All Rights Reserved. 23 Phase 1/2a - AR-276-01 - Study Overview (continued) Part 1 (up to 18 patients) Dose escalation (6 dose levels) 3+3 design Part 2 (up to 30 patients) Dose expansion, after MTD/ RP2D established Primary objectives: • Safety, MTD, RP2D • Pharmacok
Slide 24: ATRN-119 2023-2025 Anticipated Clinical Milestones
ATRN-119 2023-2025 Anticipated Clinical Milestones Milestone Timeline Phase 1/2a – Monotherapy Dose Escalation Preliminary clinical data 4Q 2023 Last Patient Enrolled 1Q 2024 Phase 1/2a – Monotherapy Dose Expansion First Patient Enrolled 2Q 2023 Last Patient Enrolled 2Q 2024 Phase 1/2a – Combination
Slide 25: Financial Summary & Capitalization
▪ Cash & Equivalents of $27.7 million as of June 30, 2023 ▪ Closed $4.9M (net) public offering in February 2023 ▪ Obtained $2.0 million non-dilutive funding via research grant from National Cancer Institute (NCI) © 2023 Aprea Therapeutics, Inc. All Rights Reserved. 25 Aprea Therapeutics (NASDAQ: APR
Slide 26: Summary
Summary © 2023 Aprea Therapeutics, Inc. All Rights Reserved. 26
Slide 27: Summary
© 2023 Aprea Therapeutics, Inc. All Rights Reserved. 27 Summary ▪ Diversified portfolio with de-risked clinical and pre-clinical plans underway ▪ Opportunities in ovarian, CRC, prostate and breast cancers ◊ Single agent and combination therapies ▪ Supportive follow-on strategy ◊ IND submission by en
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