Kura Oncology, Inc. · NASDAQ:KURA
Kura Oncology — Corporate Update (February 2025)
20 slides from Kura Oncology's corporate update, Feb 5, 2025
Slide 1: Ziftomenib Program Updates
February 5, 2025 ZIFTOMENIB PROGRAM UPDATES 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, plans regarding
Slide 3: 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 4: Agenda
AGENDA Positive FDA Feedback for Upcoming Frontline Combination Trial Designs Positive KOMET-001 Ziftomenib Monotherapy Trial in R/R NPM1-m AML 2025 Anticipated Milestones for Ziftomenib and Pipeline Programs
Slide 5: 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 6: Agenda
AGENDA Positive FDA Feedback for Upcoming Frontline Combination Trial Designs Positive KOMET-001 Ziftomenib Monotherapy Trial in R/R NPM1-m AML 2025 Anticipated Milestones for Ziftomenib and Pipeline Programs
Slide 7: Positive Topline Results from KOMET-001 Registrational Trial in R/R AML
Phase 2 registrational trial in relapsed/refractory NPM1-m AML achieved its primary CR/CRh endpoint, and the primary endpoint was statistically significant The benefit-risk profile for ziftomenib is highly encouraging, and safety and tolerability were consistent with previous reports Topline data su
Slide 8: Ziftomenib Market Potential in R/R AML
ZIFTOMENIB MARKET POTENTIAL IN R/R AML R/R AML MENIN High Unmet Need in R/R NPM1-m AML Potential for Sustained Treatment Attractive 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 years
Slide 9: Agenda
AGENDA Positive FDA Feedback for Upcoming Frontline Combination Trial Designs Positive KOMET-001 Ziftomenib Monotherapy Trial in R/R NPM1-m AML 2025 Anticipated Milestones for Ziftomenib and Pipeline Programs
Slide 10: Positive FDA Feedback on KOMET-017 Registrational Trials in Frontline AML
Single protocol encompassing two independent, randomized, placebo-controlled Phase 3 trials Single protocol designed to facilitate study start-up and execution Single protocol is attractive to sites as it provides treatment options to the broadest potential patient pool FDA aligned on endpoints, pro
Slide 11: KOMET-017: Two Phase 3 Trials Under a Single Protocol
KOMET-017: TWO PHASE 3 TRIALS UNDER A SINGLE PROTOCOL Provides Treatment Options to the Broadest Frontline AML Patient Pool Ziftomenib Venetoclax + Azacitidine Placebo Venetoclax + Azacitidine Randomized Non-Intensive Therapy Trial NPM1-m CR OS KOMET-017-NIC (Non-Intensive Combination) 7+3 Induction
Slide 12: Non-Intensive Chemotherapy (NIC) Trial
Patient Population: AML with NPM1 mutation Age 75+ or < 75 with medical comorbidities NON-INTENSIVE CHEMOTHERAPY (NIC) TRIAL Randomized, Double-Blind, Placebo-Controlled Study: Venetoclax + Azacitidine + Ziftomenib or Placebo FRONTLINE AML MENIN Dual Primary Endpoints: Complete Response Overall Surv
Slide 13: FDA Aligned Around Modified Venetoclax Dosing Regimen
Known myelosuppression with venetoclax + azacitidine from indicated dose and schedule has evolved current clinical practice Standard practice has moved towards minimizing venetoclax exposure upon response Proposed dose modifications for use of venetoclax are based on long-term follow-up exposure dat
Slide 14: Intensive Chemotherapy Trial: Proposed 3-Arm Design
Proposed 3-Arm Design to Capture Maintenance Indication in the Label for Newly Diagnosed AML INTENSIVE CHEMOTHERAPY (IC) TRIAL Randomized, Double-Blind, Placebo-Controlled Study: 7+3/Consolidation + Ziftomenib or Placebo FRONTLINE AML MENIN Primary Endpoints: CRMRD- and EFS 7+3 Induction Randomized
Slide 15: Importance of the CRMRD- Endpoint
INTENSIVE CHEMOTHERAPY (IC) TRIAL Importance of the CRMRD- Endpoint FRONTLINE AML MENIN 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
Slide 16: Ziftomenib Market Potential in Newly Diagnosed AML
Expansive Market Opportunity ZIFTOMENIB MARKET POTENTIAL IN NEWLY DIAGNOSED AML AML, acute myeloid leukemia; CR, complete response. 1. American Cancer Society. Updated June 5, 2024. Accessed August 27, 2024. https://www.cancer.org/cancer/types/acute-myeloid-leukemia/about/key-statistics.html 2. Kuma
Slide 17: Agenda
AGENDA Positive FDA Feedback for Upcoming Frontline Combination Trial Designs Positive KOMET-001 Ziftomenib Monotherapy Trial in R/R NPM1-m AML 2025 Anticipated Milestones for Ziftomenib and Pipeline Programs
Slide 18: Anticipated Upcoming Milestones
Ziftomenib ANTICIPATED UPCOMING MILESTONES: SEVERAL EXPECTED 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-
Slide 19: Financial Highlights
FINANCIAL HIGHLIGHTS (NASDAQ: KURA) Cash, Cash Equivalents and Marketable Securities Anticipated Significant Near-Term Milestones Shares Outstanding in pro forma cash as of September 30, 2024* Kura anticipates collaboration plus cash balance as of September 30, 2024 to fund ziftomenib AML program to
Slide 20: Ziftomenib Program Updates
February 2025 ZIFTOMENIB PROGRAM UPDATES Our goal is to develop transformative therapies to extend and improve the lives of patients with cancer