Kura Oncology, Inc. · NASDAQ:KURA
Kura Oncology — Investor Day (June 2025)
33 slides from Kura Oncology's investor day presentation, Jun 18, 2025
Slide 1: 2025 EHA Analyst and Investor Event
June 18, 2025 2025 EHA 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: Ziftomenib
ZIFTOMENIB Targeted investigational menin inhibitor for relapsed/refractory and newly diagnosed acute myeloid leukemia (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 ac
Slide 4: Agenda
AGENDA Ziftomenib Combined with Intensive Induction Chemotherapy (7+3) in Newly Diagnosed NPM1-m or KMT2A-r AML: Updated Phase 1a/b Results from KOMET-007 Unmet Need in Newly Diagnosed AML Ziftomenib Global Development Plan and KOMET-017 Phase 3 Clinical Trials Ziftomenib Market Opportunity in Newly
Slide 5: Key Opinion Leaders and Invited Participants
KEY OPINION LEADERS AND INVITED PARTICIPANTS Harry Erba, M.D., Ph.D. Director of Leukemia Program at the Duke Cancer Institute Ghayas C. Issa, M.D. Associate Professor of Leukemia at The University of Texas MD Anderson Cancer Center
Slide 6: Unmet Need in Newly Diagnosed AML
UNMET NEED IN NEWLY DIAGNOSED AML Ghayas C. Issa, M.D.
Slide 7: Significant Unmet Need Remains for AML Patients
SIGNIFICANT UNMET NEED REMAINS FOR AML PATIENTS AML, acute myeloid leukemia; CR, complete response. 1. National Cancer Institute. Accessed May 25, 2025. https://seer.cancer.gov/statfacts/html/amyl.html 2. Kumar CC. Genes Cancer. 2011;2(2):95-107. doi:10.1177/1947601911408076. ~ 70% Up to 70% of pati
Slide 8: Prevalence of Ziftomenib-Eligible Patients
PREVALENCE OF ZIFTOMENIB-ELIGIBLE PATIENTS UP TO 50% OF AML PATIENTS MAY BENEFIT FROM MENIN INHIBITOR THERAPY AML, acute myeloid leukemia; KMT2Ar, lysine methyltransferase 2A rearrangement; NPM1-m, mutated nucleophosmin 1; NPM1m, nucleophosmin 1 mutation; FLT3m, FMS‐like tyrosine kinase 3 mutation;
Slide 9: Ziftomenib Targets the Menin Pathway, a Foundational Target in AML
ZIFTOMENIB TARGETS THE MENIN PATHWAY, A FOUNDATIONAL TARGET IN AML Inhibiting the menin-KMT2A complex downregulates HOXA9/MEIS1, leading to differentiation of leukemic blasts5 KMT2A (MLL) and NPM1 sit upstream from major AML targets (i.e., FLT3, BCL2 and IDH1/2)4 In ~35–40% of AML, leukemogenesis is
Slide 10: Ziftomenib Combined with Intensive Induction Chemotherapy (7+3)
S136 1Duke Cancer Institute, Durham, NC, USA; 2Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA; 3Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; 4Weill Cornell Medicine and The New York Presbyterian Hospital, New York, NY, USA; 5University of Texas Southwestern Me
Slide 11: KOMET-007: Ongoing Combination Trial in Newly Diagnosed AML
KOMET-007: ONGOING COMBINATION TRIAL OF ZIFTOMENIB IN NEWLY DIAGNOSED AML Ziftomenib started on Cycle 1 Day 8 and administered continuously thereafter. Cytarabine administered on Cycle 1 Days 1–7; daunorubicin on Cycle 1 Days 1–3; re-induction cycles allowed based on bone marrow biopsy results Here
Slide 12: KOMET-007 in 1L AML: Safety and Efficacy Populations
KOMET-007 in 1L AML: SAFETY AND EFFICACY POPULATIONS 82 Enrolled and treated with Ziftomenib 600 mg / 7+3 combination 49 NPM1-m 44 NPM1-m 30 On-treatmentb 2 Received HSCT 14 Discontinued 3 Relapsed/Refractory 1 Withdrew 2 Deathc 8 Otherd 33 KMT2A-r 27 KMT2A-r 19 On-treatmentb 6 Received HSCT, with 1
Slide 13: Baseline Characteristics and Disposition: 1L AML
BASELINE CHARACTERISTICS AND DISPOSITION: 1L AML (N=82) Data cutoff: Mar 21, 2025. ECOG PS, Eastern Cooperative Oncology Group performance status; ITD, internal tandem duplication. NPM1-m KMT2A-r All Patients 600 mg (n=49) 600 mg (n=33) 600 mg (N=82) Median age, years (range) 60 (30–71) 43 (18–70) 5
Slide 14: Safety and Tolerability of Ziftomenib with 7+3: TEAEs
SAFETY AND TOLERABILITY OF ZIFTOMENIB IN COMBINATION WITH 7+3 in 1L AML (N=82) TEAEs in ≥25% of All Patients Data cutoff: Mar 21, 2025. 1. Lin et al. Blood Adv. 2021;5(6):1719-28. TEAE, treatment-emergent adverse event. Ziftomenib safety profile in combination with intensive chemotherapy was similar
Slide 15: Safety and Tolerability: Grade ≥3 TEAEs
SAFETY AND TOLERABILITY OF ZIFTOMENIB IN COMBINATION WITH 7+3 in 1L AML (N=82) Grade ≥3 TEAEs in ≥10% of All Patients n (%) NPM1-m KMT2A-r All Patients 600 mg (n=49) 600 mg (n=33) 600 mg (N=82) Grade ≥3 42 (86) 29 (88) 71 (87) Febrile neutropenia 25 (51) 20 (61) 45 (55) Platelet count decreased 23 (
Slide 16: Clinical Activity in Response-Evaluable 1L Patients
CLINICAL ACTIVITY IN ALL RESPONSE-EVALUABLEa 1L PATIENTS (N=71) a Patients who had ≥1 response assessment or who had died. b Among evaluable responders tested for MRD per local assay (NGS, RT-qPCR, FISH, flow cytometry). Preliminary central testing also shows concordance with local MRD-negative rate
Slide 17: Duration of Treatment and Outcomes in NPM1-m 1L AML
DURATION OF TREATMENT & PRELIMINARY CLINICAL OUTCOMES IN NPM1-m 1L AML Data cutoff: Mar 21, 2025. aAmong response-evaluable patients. bPatients on-treatment or in long-term follow-up. CR / CRh / CRi, complete remission with full / partial / incomplete hematologic recovery; HSCT, hematopoietic stem c
Slide 18: Duration of Treatment and Outcomes in KMT2A-r 1L AML
DURATION OF TREATMENT & PRELIMINARY CLINICAL OUTCOMES IN KMT2A-r 1L AML Duration of Treatment (weeks) For KMT2A-r, after a median follow-up of 15.7 weeks (range 1.1–40.3): Median duration of CR: 25.6 weeks (95% CI 8.3–not estimable)a and follow-up continues Median OS was not reacheda 6 KMT2A-r patie
Slide 19: Neutrophil and Platelet Recovery in CRc Responders
NEUTROPHIL AND PLATELET RECOVERY IN CRc RESPONDERS: 1L AML Data cutoff: Mar 21, 2025. 1. Lancet JE et al. J Clin Oncol. 2018; 36(26):2684-92; 2. Erba HP et al. Lancet. 2023; 401(10388):1571-83. ANC, absolute neutrophil count; CRc, composite complete remission. Median days (range), Cycle 1 NPM1-m KM
Slide 20: Conclusions
CONCLUSIONS In the ongoing KOMET-007 study, ziftomenib 600 mg QD combined with 7+3 was well tolerated, with a safety profile consistent with previous reports Low rates of ziftomenib-related cytopenia and no additional myelosuppression observed with the combination Ziftomenib 600 mg QD did not delay
Slide 21: Ziftomenib Global Development Plan and KOMET-017 Phase 3 Clinical Trials
ZIFTOMENIB GLOBAL DEVELOPMENT PLAN AND KOMET-017 PHASE 3 CLINICAL TRIALS Mollie Leoni, M.D. – Chief Medical Officer, Kura Oncology Ghayas C. Issa, M.D.
Slide 22: Kura and Kyowa Kirin Investigating Ziftomenib Across the AML Continuum
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-001 R/R NPM1-m AML KOMET-007 R/R Zifto + Ven/Aza R/R Zifto + Ven Investigator-/Company-Sponsored Studi
Slide 23: KOMET-017 Phase 3 Trial Designs
Expected to start in 2H 2025 (see Zeidan AM et al. EHA 2025 Abstract #PB2573) KOMET-017-NIC: Non-intensive therapy – Ziftomenib + ven/aza combo Patients NPM1-m AML Age ≥75 yrs, or 18 to <75 yrs with comorbidities Arm B Arm A Primary endpoints CR OS Ziftomenib Venetoclax + Azacitidine Placebo Venetoc
Slide 24: Importance of the CR MRD-negative Endpoint
Importance of the CRMRD- Endpoint Published data suggest CR MRD- may correlate better with long-term survival than morphologic CR alone Literature highlights significant impact of NPM1-m MRD negativity on long-term survival and the implication on consolidation therapy choices Higher rates of CR MRD
Slide 25: Ziftomenib Market Opportunity in Newly Diagnosed NPM1-m and KMT2A-r AML
ZIFTOMENIB MARKET OPPORTUNITY IN NEWLY DIAGNOSED NPM1-m AND KMT2A-r AML Brian Powl – Chief Commercial Officer, Kura Oncology
Slide 26: Hematologist/Oncologist Views on KOMET-007-IC Data
HEMATOLOGIST / ONCOLOGIST VIEWS ON KOMET-007-IC PRELIMINARY CLINICAL DATA PRESENTED AT EHA 2025 “The 007 data looked good, especially the CR rate holding up for the KMT2Ar cohort” “We are embarking on a new era of menin inhibitors in combination with frontline therapy in newly diagnosed AML w/ NPM1m
Slide 27: Expansive Market Opportunity in Newly Diagnosed AML
Expansive Market Opportunity ZIFTOMENIB MARKET POTENTIAL IN NEWLY DIAGNOSED AML AML, acute myeloid leukemia; CR, complete response. 1. Kumar CC. Genes Cancer. 2011;2(2):95-107. doi:10.1177/1947601911408076 2. National Cancer Institute. Accessed May 25, 2025. https://seer.cancer.gov/statfacts/html/am
Slide 28: Corporate Overview
CORPORATE OVERVIEW Troy Wilson, Ph.D., J.D. – Chief Executive Officer, Kura Oncology
Slide 29: 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 Total market opportunity in AML could exceed $7B per year in the U.S. Positive topline results from KOMET-001 study in R/R NPM1-m AML; Priority review and PDUFA action
Slide 30: 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 31: Financial Highlights
FINANCIAL HIGHLIGHTS (NASDAQ: KURA) Cash, Cash Equivalents and Short-term Investments Anticipated Significant Near-Term Milestones 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 ziftomenib AML prog
Slide 32: Questions & Answers
QUESTIONS & ANSWERS a
Slide 33: Thank You
THANK YOU Our goal is to develop transformative therapies to extend and improve the lives of patients with cancer