KURA
Published on 05/12/2026 at 04:27 pm EDT
Leading the Next Era of
Precision Medicine
May 12, 2026 1
Commercial-stage precision oncology company
KOMZIFTI (ziftomenib) approved for treatment of
adult patients with R/R NPM1-m AML
Comprehensive ziftomenib clinical development strategy designed to address up to 50% of AML patients, representing a ~$7 billion U.S. total addressable market
Cancer is best treated via combinations1: our novel agents integrate with and enhance existing therapies to overcome treatment gaps and improve patient outcomes
Deep pipeline of potentially transformative therapies, positioning company for long-term, sustainable growth
NASDAQ: KURA
Gilad Y, Gellerman G, Lonard DM, O'Malley BW. Drug Combination in Cancer Treatment-From Cocktails to 3
Conjugated Combinations. Cancers (Basel). 2021 Feb 7;13(4):669.
ADVANCING A DIVERSIFIED PIPELINE
Program
Clinical Trial
Development Approach
KOMZIFTI (ziftomenib)* monotherapy
Research
R/R NPM1-m AML
Phase 1 Dose Escalation
Phase 1 Dose Optimization
Registrational
U.S. FDA Approved
Ziftomenib Menin Inhibitor
Darlifarnib Farnesyl Transferase
Inhibitor (FTI)
KO-7246
Next-Gen Menin Inhibitor
Combination with 7+3 (IC) Combination with
venetoclax/azacitidine (NIC)
Combination with
venetoclax/azacitidine
Combination with 7+3 and quizartinib
Combination with 7+3 or venetoclax/azacitidine
Combination with gilteritinib Combinations with FLAG-IDA,
LDAC
Monotherapy
Combination with imatinib
Combination with cabozantinib Combination with adagrasib
Frontline NPM1-m or KMT2A-r AML Frontline NPM1-m AML
R/R NPM1-m or KMT2A-r AML
Frontline NPM1-m / FLT3-m AML Frontline NPM1-m or KMT2A-r AML
R/R NPM1-m / FLT3-m AML R/R NPM1-m or KMT2A-r AML
R/R Non-NPM1-m / Non-KMT2A-r AML R/R KMT2A-r ALL
GIST
RCC
NSCLC, CRC, and PDAC
Diabetes and cardiometabolic disease
* KOMZIFTI (ziftomenib) was approved by the U.S. Food and Drug Administration for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options.
The investigational agents and investigational uses of marketed products identified above have not been approved by the U.S. Food and Drug Administration (FDA). Safety and efficacy have not been established.
Progress bars indicate the stage of development based on ongoing or completed activities. A partial bar indicates a phase in progress; a full bar indicates completion of a phase. Bars do not represent scale, duration, or likelihood of success.
2026 PRIORITIES
Execute KOMZIFTI launch to establish market leadership in
R/R NPM1-m AML
Drive comprehensive data generation strategy in combination and 1L AML Ph 3 study execution
Confirm POC of darlifarnib (TORC1 inhibition) combination in RCC, CRC, NSCLC, PDAC, and other solid tumors
Advance additional preclinical assets to expand portfolio
2030+ VISION
Establish KOMZIFTI as standard of care in menin-driven AML
Achieve multiple product approvals in
major disease areas
Expand commercial franchise beyond AML
Darlifarnib in RCC, NET, and RAS- and PI3K-driven solid tumors
Ziftomenib + imatinib in GIST
Realize multi-billion-dollar revenue
potential; retain key strategic rights
5
2026 ZIFTOMENIB PRIORITIES
ESTABLISH >> Commercial Leadership
Deliver strong quarter-over-quarter growth in revenue and adoption
Achieve leading class share in R/R NPM1-m AML setting
EXECUTE >> Frontline Franchise
Drive toward first-to-market in 1L AML through enrollment of KOMET-017 trials
Present updated data on ziftomenib / 7+3 combo in 1L NPM1-m/KMT2A-r AML
Advance enrollment of KOMET-007 cohort evaluating combination of ziftomenib, 7+3 and quizartinib in 1L NPM1-m/FLT3-m AML (quad)
EXPAND >> Broaden Addressable Market
Publish practice-informing data of ziftomenib in combination with ven/aza in R/R AML
Generate and present data in NPM1-m/FLT3-m AML (25-30% of incident cases)
Expand beyond AML - ziftomenib + imatinib in GIST
6
2026 DARLIFARNIB PRIORITIES
ESTABLISH >> Combination Backbone
Generate data to position darlifarnib as a preferred combination partner for targeted therapies in solid tumors
EXECUTE >> Clinical Validation and Potential Registration
Advance RCC development
Enroll Phase 1b trial of darlifarnib + cabozantinib in 2L+ RCC
Present updated data from Phase 1a trial of darlifarnib + cabozantinib in advanced RCC
Outline registrational path
EXPAND >> Combination Potential
Present preliminary Phase 1a data for darlifarnib + adagrasib (NSCLC, CRC, PDAC)
Identify additional indications and partner darlifarnib with novel PI3Ka and RAS inhibitors
7
2026 MENIN PIPELINE PRIORITIES
IDENTIFY >> New Opportunities
Identify additional opportunities for menin inhibition in solid tumors and other diseases
ADVANCE >> Next-Generation Assets
Advance KO-7246, a next-gen menin inhibitor, for diabetes and cardiometabolic diseases
Present preclinical data highlighting transformational potential of menin inhibitors in diabetes
EXPAND >> Portfolio Breadth
Nominate a next-gen menin development candidate for combinations in solid tumors
Evaluate opportunity in ER+ driven tumors
8
Kura retains leadership and key strategic rights to ziftomenib in the U.S. to preserve strategic flexibility
50/50 U.S. co-development/co-promote with Kura booking 100% U.S. sales and leading commercial strategy and global development
Enables broad development and commercialization, including 1L fit/unfit, combos with targeted therapies, and maintenance setting
9
FINANCIAL HIGHLIGHTS AND OUTLOOK
Well-capitalized to support KOMZIFTI commercial launch and pipeline advancement
$5.8 million of KOMZIFTI net product revenue in 1Q 2026, the first full quarter of commercialization
$580.8 million in cash, cash equivalents and short-term investments as of March 31, 2026
Cash, cash equivalents and short-term investments as of March 31, 2026, together with anticipated collaboration payments under the agreement with Kyowa Kirin, are expected to fund the ziftomenib AML program through the topline results from the first pivotal Phase 3 KOMET-017 frontline trial, anticipated in 2028
10
FDA APPROVED
Please see additional Important Safety Information and full 11
Prescribing Information, including Boxed Warning.
KOMZIFTI LAUNCH OFF TO STRONG START
85 new patients starts
157 total prescriptions
1Q 2026:
First Full Quarter of Commercial Launch
$5.8 M
net product revenue
In a
PREFERRED POSITION
with many payers
First and only once-daily targeted therapy for adults with R/R NPM1-m AML
Please see additional Important Safety Information and full
Prescribing Information, including Boxed Warning. 12
UP TO 50% OF AML PATIENTS MAY BENEFIT FROM MENIN INHIBITOR THERAPY
22,010 new cases of AML diagnosed in the
U.S. each year1
AML is characterized by significant genetic heterogeneity due to driver mutations, including NPM1-m, FLT3-m, IDH1/2-m and KMT2A-r2,3
NPM1 mutations are observed in 30% to 35% of cases and are an important upstream driver mutation that uses the menin pathway4,5
1. American Cancer Society. Updated December 27, 2025. https://www.cancer.org/cancer/types/acute-myeloid-leukemia/about/key-statistics.html 2. Papaemmanuil E et al. N Engl J Med. 2016;374(23):2209-2221. doi:10.1056/NEJMoa1516192 3. The Cancer Genome Atlas Research Network. N Engl J Med. 2013;368(22):2059-2074. doi:10.1056/NEJMoa1301689 4. Burrows F et al. Poster
presented at: AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics: Discovery, Biology, and 13
Clinical Applications; October 26-30, 2017; Philadelphia, PA. 5. Falini B, Dillon R. Blood Cancer Discov. 2024;5(1):8-20.
COMPREHENSIVE DEVELOPMENT STRATEGY ADDRESSES POTENTIAL BLOCKBUSTER MARKET OPPORTUNITY
SOC in 1L;
Additional FLT3i Combinations
Significant
U.S. TAM
~$7B
Diversify Combinations in 1L and R/R
1L 7+3/Ven-Aza Topline Results
FDA Approval
R/R NPM1-m AML
~$350 -400M
Ven-Aza
Initial U.S. TAM
FLAG-IDA
7+3
FLT3i
LDAC
2028/2029
2029/2030
2030+
2026/2027
Nov 2025
14
Not for promotional use.
KOMZIFTI'S DIFFERENTIATED PROFILE
KOMZIFTI is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.
Please see additional Important Safety Information and full
Prescribing Information, including Boxed Warning. 15
IC or NIC Therapy or Tolerable Therapy
Transplant/ No Transplant
RELAPSED / REFRACTORY
1L TREATABLE
Targeted Therapy in FLT3-m,
IDH1/2-m and/or
NPM1-m
Non-Intensive Therapy/ Palliative Care
IC or NIC Therapy
Transplant/ No Transplant
Post-Transplant/ Consolidation Maintenance
KOMET-001
NPM1-m AML
KMT2A-r ALL
Non-NPM1-m / Non-KMT2A-r AML
KOMET-007
Zifto + Ven/Aza Zifto + Ven Only
KOMET-008
Zifto + FLAG-IDA
Zifto + LDAC Zifto + gilt
KOMET-007
Zifto + Ven/Aza Zifto + 7+3
Zifto + 7+3 + quiz
KOMET-017-IC
Zifto + 7+3
Placebo + 7+3
KOMET-017-NIC
Zifto + Ven/Aza Placebo + Ven/Aza
Investigator/Company-Sponsored Studies Across Adult and Pediatric Hematologic Malignancies
16
KOMET-017-NIC
(NON-INTENSIVE CHEMOTHERAPY)
N = 1,300
KOMET-017-IC
(INTENSIVE CHEMOTHERAPY)
Ziftomenib
Venetoclax + Azacitidine
ARM A
7+3
Induction
Ziftomenib
Consolidation
Randomized
NPM1-m
Randomized
NPM1-m
or KMT2A-r
ARM B
7+3
Ziftomenib
Consolidation
Placebo
KEY
Backbone
Ziftomenib SOC
Placebo
Venetoclax + Azacitidine
CR*
Placebo
OS
Endpoints
ARM C
Induction
7+3
Induction
Consolidation
CR*MRD-
Placebo
EFS
* Dual primary endpoint with potential for U.S. accelerated approval. 17
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 T. Fathi3, Gail J. Roboz4, Yazan F. Madanat5, Stephen A. Strickland6, Suresh Balasubramanian7, James K. Mangan8, Keith Pratz9, Anjali Advani10, Ivana Gojo11, Jessica K. Altman12, Marcello Rotta13, Kiran Naqvi14, Jorge Cortes15, Mark Juckett16, Leonard C. Alsfeld17, James S. Blachly18, Marina Kremyanskaya19, Neil Palmisiano20, Kalyan V. Nadiminti21, Gary Schiller22, Tara L. Lin23,
Mohamad Khawandanah24, Michael W. Schuster25, Talha Badar26, Julie Mackey Ahsan27, Tianle Chen27, Marcie Riches27, Daniel Corum27, Mollie Leoni27, and Amer M. Zeidan28
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 Medical Center, Dallas, TX, USA; 6SCRI at TriStar Centennial, Nashville, TN, USA; 7Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA; 8Moores Cancer Center, University of California, San Diego, La Jolla, CA, USA; 9Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA; 10Cleveland Clinic, Cleveland, OH, USA; 11Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 12Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA; 13Colorado Blood Cancer Institute, Denver, CO, USA; 14Chao Family Comprehensive Cancer Center, University of California Irvine Health, Orange, CA, USA; 15Georgia Cancer Center, Augusta, GA, USA; 16Department of Hematology, University of Minnesota, Minneapolis, MN, USA; 17Ochsner MD Anderson Cancer Center, New Orleans, LA, USA; 18The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA; 19Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA; 20Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA; 21Carbone Cancer Center, University of Wisconsin-Madison, Madison, WI, USA; 22David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; 23The University of Kansas Cancer Center, Kansas City, KS, USA; 24University of Oklahoma Health Sciences Center, Stephenson Cancer Center, Oklahoma, OK, USA; 25Stony Brook University Hospital Cancer Center, Stony Brook, NY, USA; 26Mayo Clinic, Jacksonville, FL, USA; 27Kura Oncology, Inc., San Diego, CA, USA; 28Yale University and Yale Cancer Center,
New Haven, CT, USA 1
8
After a median follow-up of 24.9 weeks (range 4.3-47.1):
Median duration of CR not reacheda
Median OS not reacheda
2 NPM1-m patients received HSCT
3 discontinuations due to relapse
96% (47/49) of patients remained alive and continued on-studyb
Data cutoff: Mar 21, 2025.
a Among response-evaluable patients.
b Patients on-treatment or in long-term follow-up.
19
Duration of treatment (weeks)
Ziftomenib in Combination with Venetoclax and Azacitidine in Newly Diagnosed
NPM1-m Acute Myeloid Leukemia: Phase 1b Results from KOMET-007
Gail J. Roboz, MD1, Eunice S. Wang, MD2, Amir T. Fathi, MD3, Harry Erba, MD, PhD4, Keith W. Pratz, MD5, Guru Subramanian Guru Murthy, MD, MS6, Leonard C. Alsfeld, MD7, James S. Blachly, MD8, Kiran Naqvi, MD9, Ghayas C. Issa, MD10, Ayman Qasrawi, MD11, Stephen A. Strickland, MD12, Neil D. Palmisiano, MDMS13, Jessica K. Altman, MD14, Cecilia Arana Yi, MD15, Grerk Sutamtewagul, MD16, Yazan F. Madanat, MD17, Suresh Kumar Balasubramanian, MD18, Christine M. McMahon, MD19, Hongling Zhang, MS20, Tianle Chen, PhD20, Marcie Riches, MD20, Daniel Corum, PhD20, Mollie Leoni, MD20, Amer M. Zeidan, MBBS, MHS21
1Weill Cornell Medicine and The New York Presbyterian Hospital, New York, NY; 2Roswell Park Comprehensive Cancer Center, Buffalo, NY; 3Massachusetts General Hospital, Harvard Medical School, Boston, MA; 4Duke Cancer Institute, Durham, NC; 5Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; 6Froedtert & Medical College of Wisconsin, Milwaukee, WI; 7Ochsner MD Anderson Cancer Center, New Orleans, LA; 8The Ohio State University Comprehensive Cancer Center, Columbus, OH; 9Chao Family Comprehensive Cancer Center, University of California Irvine Health, Orange, CA; 10Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX; 11Department of Internal Medicine, University of Kentucky, Lexington, KY; 12SCRI at TriStar Centennial, Nashville, TN; 13Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; 14Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; 15Division of Hematology and Oncology, Mayo Clinic, Phoenix, AZ; 16University of Iowa Health Care, Holden Comprehensive Cancer Center, Iowa City, IA; 17The University of Texas Southwestern Medical Center, Dallas, TX; 18Karmanos Cancer Institute, Wayne State University, Detroit, MI; 19Anschutz Medical Campus, Division of Hematology, University of Colorado School of Medicine, Aurora, CO; 20Kura Oncology, Inc., San Diego, CA; 21Yale University and Yale Comprehensive Cancer Center, New Haven, CT
20
Presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition on December 6-9, 2024 in Orlando, FL. Presentation ID 766.
202
Disclaimer
Kura Oncology Inc. published this content on May 12, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 12, 2026 at 20:24 UTC.