Kura Oncology, Inc. · NASDAQ:KURA
Kura Oncology — 2025 ASCO Analyst and Investor Event
30 slides from Kura Oncology's conference presentation, Jun 3, 2025
Slide 1: 2025 ASCO Analyst and Investor Event
June 2, 2025 2025 ASCO ANALYST AND INVESTOR EVENT Our goal is to develop transformative therapies to extend and improve the lives of patients with cancer Exhibit 99.1
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements. Such statements include, but are not limited to, statements regarding our research, preclinical and clinical development activities, plans and projected timelines for ziftomenib, KO-2806 and tipifarnib, expectations re
Slide 3: Acute Myeloid Leukemia (AML)
ACUTE MYELOID LEUKEMIA (AML) Approximately 22,010 people are diagnosed with AML each year in the United States1 5-year survival rate for AML is 33% and as low as 8.6% for patients aged ≥ 65 years2 Significant unmet need remains for AML patients Up to 50% of AML patients may benefit from menin inhibi
Slide 4: Ziftomenib
ZIFTOMENIB Targeted investigational menin inhibitor for relapsed/refractory and newly-diagnosed AML New Drug Application (NDA) based on positive results from the Phase 2 KOMET-001 trial NDA granted Priority Review and assigned Prescription Drug User Fee Act (PDUFA) target action date of November 30,
Slide 5: Agenda
AGENDA Ziftomenib Global Development Plan Ziftomenib in R/R NPM1-m AML: Phase 1b/2 Clinical Activity and Safety Results from the Pivotal KOMET-001 Study Ziftomenib Market Opportunity in R/R NPM1-m AML
Slide 6: Key Opinion Leaders and Invited Participants
KEY OPINION LEADERS AND INVITED PARTICIPANTS Eunice Wang, M.D. Chief of Leukemia Service, Roswell Park Comprehensive Cancer Center, Buffalo, NY Professor of Oncology in the Department of Medicine at Roswell Park Amer Zeidan, MBBS Chief, Division of Hematologic Malignancies, Director of Hematology Ea
Slide 7: Ziftomenib in R/R NPM1-mutant AML: Phase 1b/2 Results from KOMET-001
Ziftomenib in Relapsed / Refractory (R/R) NPM1-mutant Acute Myeloid Leukemia (AML): Phase 1b/2 Clinical Activity and Safety Results from the Pivotal KOMET-001 Study Eunice S. Wang1, Pau Montesinos2, Ghayas C. Issa3, James Foran4, Harry Erba5, Eduardo Rodríguez-Arbolí6, Kateryna Fedorov7, Maël Heibli
Slide 8: KOMET-001: Pivotal Trial of Ziftomenib Monotherapy
KOMET-001: PIVOTAL TRIAL OF ZIFTOMENIB MONOTHERAPY IN R/R NPM1-m AML Phase 1a Dose Escalation Phase 1b Validation Cohorts Phase 1b Expansion 50 mg QD ~ ~ 100 mg QD 1000 mg QD Cohort 1: 200 mg QD Cohort 2: 600 mg QD • Safety and tolerability • Pharmacokinetics • Early evidence of antitumor activity •
Slide 9: Baseline Characteristics
BASELINE CHARACTERISTICS: R/R NPM1-m AML Data cutoff: Dec 20, 2024. ECOG PS, Eastern Cooperative Oncology Group performance status; HSCT, hematopoietic stem cell transplantation; ITD, internal tandem duplication; QD, once daily; RP2D, recommended phase 2 dose; TKD, tyrosine kinase domain. n (%) Zift
Slide 10: Response & Duration of Response
RESPONSE & DURATION OF RESPONSE: R/R NPM1-m AML Primary Phase 2 endpoint met (P-value=0.0058)* vs. 12% historical control rate1 For Phase 2 patients, after a median follow-up of 4.1 months (range, 0.1–19.7): n (%) Ziftomenib RP2D 600 mg QD Phase 2 (N=92) Pooled Phase 1b/2 (N=112) CR/CRh 21 (23) 28 (
Slide 11: Comparable CR/CRh Across Pre-specified Subgroups
COMPARABLE CR/CRh ACROSS PRE-SPECIFIED SUBGROUPS: R/R NPM1-m AML Data cutoff: Dec 20, 2024. CR, complete response; CRh, complete response with partial hematologic recovery; ECOG PS, Eastern Cooperative Oncology Group performance status; HSCT, hematopoietic stem cell transplant; ITD, internal tandem
Slide 12: Transfusion Independence
a TRANSFUSION INDEPENDENCE: R/R NPM1-m AML Additional benefit beyond CR/CRh Ziftomenib RP2D 600 mg QD Phase 2 (N=92) Total post-baseline transfusion independence Transfusion conversion (TD to TI) ratea, n/N (%) 17/82 (21) 95% CIb 13–31 Maintenance of transfusion independence (TI to TI) ratec, n/N (%
Slide 13: Overall Survival
OVERALL SURVIVAL: R/R NPM1-m AML All Patients (Pooled Phase 1b/2) Responders* vs. Non-Responders *Responders included CRc, MLFS, and PR. Data cutoff: Dec 20, 2024. CRc, composite complete remission; MLFS, morphologic leukemia free state; OS, overall survival; PR, partial response. Median OS: 6.1 mon
Slide 14: Safety & Tolerability of Ziftomenib
SAFETY & TOLERABILITY OF ZIFTOMENIB IN R/R NPM1-m AML (SAFETY POPULATION) Data cutoff: Dec 20, 2024. 1. Wang ES et al. Lancet Oncol 2024; 25(10):1310-24. 2. Fathi AT et al. Blood. 2024;144(Suppl_1):2880. AE, adverse event; QD, once daily; QTc, corrected QT interval; RP2D, recommended phase 2 dose. Z
Slide 15: Safety & Tolerability of Ziftomenib
SAFETY & TOLERABILITY OF ZIFTOMENIB IN R/R NPM1-m AML (SAFETY POPULATION) Data cutoff: Dec 20, 2024. 1. Wang ES et al. Lancet Oncol. 2024; 25(10):1310-24. 2. Fathi AT et al. Blood. 2024;144(Suppl_1):2880. AE, adverse event; QD, once daily; QTc, corrected QT interval; RP2D, recommended phase 2 dose.
Slide 16: Conclusions
CONCLUSIONS In the pivotal KOMET-001 phase 2 study, the primary endpoint was met Ziftomenib achieved clinically meaningful, MRD-negative responses in this heavily pretreated R/R NPM1-m AML population Similar response rates were seen, regardless of prior therapies, including HSCT and venetoclax Zifto
Slide 17: Ziftomenib Global Development Plan
ZIFTOMENIB GLOBAL DEVELOPMENT PLAN Mollie Leoni, M.D. – Chief Medical Officer, Kura Oncology
Slide 18: Kura and Kyowa Kirin Investigating Ziftomenib Across the AML Continuum
KURA AND KYOWA KIRIN ARE INVESTIGATING ZIFTOMENIB ACROSS THE AML CONTINUUM IN UP TO 50% OF PATIENTS for Whom Menin-KMT2A Pathway is a Disease Driver FRONTLINE IC or NIC Tx or tolerable therapy Transplant/ No Transplant Targeted Tx if FLT3m and/or NPM1m Non-Intensive therapy/ Palliative Care KOMET-00
Slide 19: Ziftomenib with Intensive Induction Chemotherapy: Updated KOMET-007 Results
Ziftomenib combined with intensive induction chemotherapy (7+3) in newly diagnosed NPM1-m or KMT2A-r acute myeloid leukemia: Updated phase 1a/b results from KOMET-007 Harry Erba1, Eunice S. Wang2, Amir Fathi3, Gail J. Roboz4, Yazan F. Madanat5, Stephen A. Strickland6, Suresh Balasubramanian7, James
Slide 20: KOMET-017: Phase 3 Pivotal 1L Combination Studies
KOMET-017: PHASE 3 ZIFTOMENIB PIVOTAL 1L COMBINATION STUDIES Provides Potential Treatment Options to the Broadest Frontline AML Patient Pool KOMET-017-NIC: Non-intensive therapy – Ziftomenib + ven/aza chemotherapy Patients NPM1-m AML Age ≥75 yrs, or 18 to <75 yrs with comorbidities Arm B Arm A Prima
Slide 21: Ziftomenib Market Opportunity
ZIFTOMENIB MARKET OPPORTUNITY IN R/R NPM1-m AML Brian Powl – Chief Commercial Officer, Kura Oncology
Slide 22: Hematologist/Oncologists Acknowledge Potential Advantages of Ziftomenib
HEMATOLOGIST / ONCOLOGISTS ACKNOWLEDGE POTENTIAL ADVANTAGES OF ZIFTOMENIB “You don’t have to think about dose based on being on an azole. You can take it once a day instead of twice a day, and you don’t have to come for weekly EKGs. That ends up being quite a bit more convenient” “the [lack of] myel
Slide 23: KOMET-001 Clinical Data Highlight Key Differences Favoring Ziftomenib
KOMET-001 CLINICAL DATA HIGHLIGHT KEY DIFFERENCES FAVORING ZIFTOMENIB Low myelosuppressive effect Does not have a clinically significant effect on QTc prolongation; does not require frequent monitoring for QTc prolongation SAFETY CONVENIENCE Patient-friendly, once-daily dosing Does not require dose
Slide 24: Ziftomenib Market Potential in R/R AML
ZIFTOMENIB MARKET POTENTIAL IN R/R AML High Unmet Need in R/R NPM1-m AML Potential for Sustained Treatment Attractive Total U.S. Market Opportunity 20% are primary refractory; ~50% will relapse who achieved an initial CR1-5 20% ~50% Fewer than 10% of all patients with R/R AML are alive at 5 years6 <
Slide 25: Corporate Overview
CORPORATE OVERVIEW Troy Wilson, Ph.D., J.D. – Chief Executive Officer, Kura Oncology
Slide 26: Kura Is Advancing a Robust Pipeline of Therapeutic Product Candidates
KURA IS ADVANCING A ROBUST PIPELINE OF THERAPEUTIC PRODUCT CANDIDATES Ziftomenib: Potentially Best-in-Class Menin Inhibitor for AML Relapsed/refractory (R/R) and frontline acute myeloid leukemia (AML) market opportunity could exceed $7B per year in the U.S. Positive topline results from KOMET-001 st
Slide 27: Anticipated Upcoming Milestones
Ziftomenib ANTICIPATED UPCOMING MILESTONES: ADDITIONAL 2025 DATA READ-OUTS ACROSS MULTIPLE PROGRAMS Report topline results from KOMET-001 Phase 2 registration-directed trial in R/R NPM1-m AML ü FDA feedback on KOMET-017 registration-enabling protocol in 1L NPM1-m and KMT2A-r intensive and non-intens
Slide 28: Financial Highlights
FINANCIAL HIGHLIGHTS (NASDAQ: KURA) Cash, Cash Equivalents and Marketable Securities Anticipated Significant Near-Term Milestones in pro forma cash, cash equivalents and short-term investments as of March 31, 2025* Kura anticipates collaboration plus cash balance as of March 31, 2025 to fund ziftome
Slide 29: Questions & Answers
QUESTIONS & ANSWERS a
Slide 30: Thank You
THANK YOU Our goal is to develop transformative therapies to extend and improve the lives of patients with cancer