# EDGAR Filing Document

**Accession Number:** 0001422143
**File Stem:** 0001193125-25-133717
**Filing Date:** 2025-6
**Character Count:** 40894
**Document Hash:** 55f4fbb675ff7832046b8735b669aae5
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-133717.hdr.sgml**: 20250603

**ACCESSION NUMBER**: 0001193125-25-133717

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 43

**CONFORMED PERIOD OF REPORT**: 20250601

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250603

**DATE AS OF CHANGE**: 20250603

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Kura Oncology, Inc.
- **CENTRAL INDEX KEY:** 0001422143
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 611547851
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37620
- **FILM NUMBER:** 251017075

**BUSINESS ADDRESS:**
- **STREET 1:** 12730 HIGH BLUFF DRIVE, SUITE 400
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92130
- **BUSINESS PHONE:** (858) 500-8800

**MAIL ADDRESS:**
- **STREET 1:** 12730 HIGH BLUFF DRIVE, SUITE 400
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92130

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** ZETA ACQUISITION CORP III
- **DATE OF NAME CHANGE:** 20071227

?xml version='1.0' encoding='ASCII'? 8-K

### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### WASHINGTON, D.C. 20549

### FORM 8-K

#### CURRENT REPORT

#### Pursuant to Section 13 or 15(d)

#### of the Securities Exchange Act of 1934

#### Date of Report (Date of earliest event reported): June 1, 2025

## KURA ONCOLOGY, INC.

#### (Exact name of Registrant as Specified in Its Charter)

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| | | |
|:---|:---|:---|
| **Delaware** | **001-37620** | **61-1547851** |
| **(State or Other Jurisdiction**<br> **of Incorporation)** | **(Commission**<br> **File Number)** | **(IRS Employer**<br> **Identification No.)** |

---

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| | |
|:---|:---|
| **12730 High Bluff Drive, Suite 400, San Diego, CA** | **92130** |
| **(Address of Principal Executive Offices)** | **(Zip Code)** |

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#### Registrant's Telephone Number, Including Area Code: (858) 500-8800

#### N/A

#### (Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading<br>Symbol(s)** | **Name of each exchange<br>on which registered** |
| Common Stock, par value $0.0001 per share | KURA | The Nasdaq Global Select Market |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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|:---|:---|
| **Item 8.01** | **Other Events.**  |

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On June 1, 2025, Kura Oncology, Inc. (the "Company") and Kyowa Kirin Co., Ltd. ("Kyowa Kirin") announced that the U.S. Food and Drug Administration ("FDA") has accepted the Company's New Drug Application ("NDA") seeking full approval for ziftomenib as a treatment for adult patients with relapsed or refractory ("R/R") acute myeloid leukemia ("AML") with a nucleophosmin 1 ("NPM1") mutation. The application has been granted Priority Review and assigned a Prescription Drug User Fee Act target action date of November 30, 2025. The Company and its partners at Kyowa Kirin look forward to supporting FDA with its review of the ziftomenib NDA.

The NDA is based on results from the Phase 2 KOMET-001 registrational trial in R/R NPM1-mutant ("NPM1-m") AML (NCT #04067336). The KOMET-001 registration-directed trial is designed to assess evidence of clinical activity, safety and tolerability of ziftomenib, the only investigational therapy to receive Breakthrough Therapy Designation ("BTD") from the FDA for treatment of R/R NPM1-mutant AML. In addition to BTD, ziftomenib has received Fast Track and Orphan Drug Designations.

On June 2, 2025, the Company and Kyowa Kirin announced positive pivotal results from the KOMET-001 Phase 2 registration-directed trial of ziftomenib, a once-daily, oral investigational menin inhibitor, in patients with R/R NPM1-m AML.

The KOMET-001 Phase 2 population included 92 adult patients with R/R NPM1-m AML. The median age was 69 (range: 33 to 84). Patients were heavily pretreated, with 33% having received three or more prior lines of therapy (median prior lines: 2) and 59% having been previously treated with venetoclax.

A complete remission ("CR") plus CR with partial hematological recovery ("CRh") rate of 23% (21/92) was observed among patients with R/R NPM1-m AML in the Phase 2 portion of the KOMET-001 trial. Among those 21 patients who achieved CR/CRh, 13 had a CR and eight had a CRh. The median duration of CR/CRh responses was 3.7 months (95% confidence interval ("CI"): 1.9, not estimable) and the restricted mean duration of response was 4.3 months (95% CI: 3.1, 5.6) at the time of the data cutoff. Minimal residual disease ("MRD") status was assessed in 19 of 21 patients who achieved CR/CRh, and 63% (12/19) of these patients were MRD-negative.

Comparable CR/CRh rates were observed across pre-specified subgroups, regardless of prior hematopoietic stem cell transplantation, prior venetoclax or FLT3/IDH co-mutations. Additional patient benefit beyond CR/CRh was observed with a rate of transfusion conversion of 21% (17/82; 95% CI: 13-31) and a rate of maintenance of transfusion independence of 20% (2/10; 95% CI: 3-56). A median overall survival ("OS") of 16.4 months (95% CI, 9.6–20.4) was observed for responders (patients who achieved CR, CRh, CRi/CRp, morphologic leukemia-free state or partial response) and a median OS of 3.5 months (95% CI, 2.5–4.0) was observed among non-responders.

The safety population included 112 adult patients with R/R NPM1-m AML from the pooled Phase 1b and Phase 2 portions of the KOMET-001 trial. The safety profile observed with ziftomenib in this population was consistent with previously reported data. Treatment-related adverse events ("TRAEs") led to treatment discontinuations in 3% of patients. TRAEs of Grade ≥3 which occurred in more than 10% of patients were limited to differentiation syndrome ("DS," 13%) , which was well managed by protocol-specified mitigation strategies and no Grade 4/5 treatment-related DS was observed. Although QTc prolongation (1 Gr2; 2 Gr3) was reported in three patients per investigator assessment, all three patients were on concomitant medications associated with QTc prolongation, two had electrolyte abnormalities and one had a prior diagnosis of atrial fibrillation.

On June 2, 2025, the Company hosted a virtual investor event and presented certain materials related to the Company (the "Presentation"). A copy of the Presentation is attached hereto as Exhibit 99.1 and incorporated herein by reference.

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#### Forward-Looking Statements
Statements contained in this Current Report on Form 8-K regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding, among other things, the efficacy, safety and therapeutic potential of ziftomenib; interactions with the FDA relating to the Company's NDA for ziftomenib; the anticipated timing of FDA approval of the Company's NDA and the potential to benefit patients with R/R NPM1-m AML.

Any forward-looking statements in this Current Report on Form 8-K are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that the Company may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, the risk that the collaboration with Kyowa Kirin is unsuccessful and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs, as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025 filed with the Securities and Exchange Commission ("SEC") on May 1, 2025, as well as discussions of potential risks, uncertainties and other important factors in the Company's other filings and reports with the SEC. All forward-looking statements contained in this Current Report on Form 8-K speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.**  |

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(d) <u>Exhibits</u>.

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| | |
|:---|:---|
| **Exhibit**<br> **Number** | **Description** |
| 99.1 | [Presentation Materials of Kura Oncology, Inc.](d917067dex991.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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#### SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

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| | | |
|:---|:---|:---|
|  | **KURA ONCOLOGY, INC.** | **KURA ONCOLOGY, INC.** |
| Date: June 3, 2025 | By: | /s/ Teresa Bair |
|  |  | **Teresa Bair** |
|  |  | **Chief Legal Officer** |

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## Exhibit 99.1

![Slide 1](g917067ex99_1s1g1.jpg)

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

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![Slide 2](g917067ex99_1s2g1.jpg)

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 regarding the relative benefits of our product candidates versus competitive therapies, expectations regarding the therapeutic and commercial potential of our product candidates, and expectations regarding our collaboration with Kyowa Kirin. The words "believe," "may," "should," "will," "estimate," "promise," "plan", "continue," "anticipate," "intend," "expect," "potential" and similar expressions (including the negative thereof) are intended to identify forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: our preclinical studies and clinical trials may not be successful; the U.S. Food and Drug Administration (FDA) may not agree with our interpretation of the data from clinical trials of our product candidates; we may decide, or the FDA may require us, to conduct additional clinical trials or to modify our ongoing clinical trials; we may experience delays in the commencement, enrollment, completion or analysis of clinical testing for our product candidates, or in the reporting of data from such clinical testing, or significant issues regarding the adequacy of our clinical trial designs or the execution of our clinical trials may arise, which could result in increased costs and delays, or limit our ability to obtain regulatory approval; our product candidates may not receive regulatory approval or be successfully commercialized; unexpected adverse side effects or inadequate therapeutic efficacy of our product candidates could delay or prevent regulatory approval or commercialization; we may not be able to obtain additional financing; and our collaboration with Kyowa Kirin may not be successful. Additional risks and uncertainties may emerge from time to time, and it is not possible for Kura's management to predict all risk factors and uncertainties. All forward-looking statements contained in this presentation speak only as of the date on which they were made. Other risks and uncertainties affecting us are described more fully in our filings with the Securities and Exchange Commission. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. This presentation may also contain statistical, preclinical and clinical data obtained from and prepared by third parties. The recipient is cautioned not to give undue weight to such disclosures. Neither the Company nor any other person makes any representation as to the accuracy or completeness of such data or undertakes any obligation to update such data after the date of this presentation.

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![Slide 3](g917067ex99_1s3g1.jpg)

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 inhibitor therapy2-7 American Cancer Society. Accessed May 25, 2025. https://www.cancer.org/cancer/types/acute-myeloid-leukemia/about/key-statistics.html National Cancer Institute. Accessed May 25, 2025. https://seer.cancer.gov/statfacts/html/amyl.html Issa GC et al. Leukemia. 2021;35(9):2482-2495. doi:10.1038/s41375- 021-01309-y Candoni A, Coppola G. Hematol Rep. 2024;16(2):244-254. doi:10.3390/hematolrep16020024 Bertrums EJM et al. Haematologica. 2023;108(8):2044-2058. doi:10.3324/haematol.2022.281653 National Cancer Institute. Accessed October 16, 2024. https://seer.cancer.gov/seertools/hemelymph/ 51f6cf59e3e27c3994bd547d/ National Cancer Institute. Accessed October 16, 2024. https://seer.cancer.gov/seertools/hemelymph/5a7e288d1ef557f9c8636d31/

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![Slide 4](g917067ex99_1s4g1.jpg)

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, 2025 Kyowa Kirin partnership funds expansive AML development program through 1L U.S. commercialization

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![Slide 5](g917067ex99_1s5g1.jpg)

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

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![Slide 6](g917067ex99_1s6g1.jpg)

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 Early Therapeutics Research, Yale Cancer Center Professor of Medicine (Hematology), Yale University

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![Slide 7](g917067ex99_1s7g1.jpg)

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 Heiblig8, Florian Heidel9, Jessica K. Altman10, Maria R. Baer11, Lionel Ades12, Kristen Pettit13, Pierre Peterlin14, Cristina Papayannidis15, Zijing Zhang16, Marcie Riches16, Daniel Corum16, Mollie Leoni16, and Amir T. Fathi17 1Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA; 2Hospital Universitari i Politècnic La Fe, Valencia, Spain; 3The University of Texas MD Anderson Cancer Center, Houston, TX, USA; 4Mayo Clinic Comprehensive Cancer Center, Mayo Clinic, Jacksonville, FL, USA; 5Duke Cancer Institute, Durham, NC, USA; 6Hospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla (IBiS/CSIC), University of Seville, Seville, Spain; 7Vanderbilt-Ingram Cancer Center, Nashville, TN, USA; 8Centre Hospitalier Lyon Sud, Lyon, France; 9Hannover Medical School, Hannover, Germany; 10Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA; 11University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, MD, USA; 12Hôpital Saint-Louis, Paris, France; 13University of Michigan, Ann Arbor, MI, USA; 14CHU de Nantes-Hôtel-Dieu, Nantes, France; 15IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", Bologna, Italy; 16Kura Oncology, Inc., San Diego, CA, USA; 17Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA Eunice S. Wang, M.D., Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA #6506

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![Slide 8](g917067ex99_1s8g1.jpg)

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 • Safety and tolerability • Pharmacokinetics • Clinical activity Continue enrollment of Phase 1b validation cohort(s) consistent with FDA's Project Optimus • Safety and tolerability • Pharmacokinetics • Clinical activity Completed Expansion of 600 mg QD Phase 2 Registration-Enabling • Primary endpoint: CR/CRh • Key secondary endpoints: Duration of CR/CRh CR/CRh MRD negativity Transfusion independence Adverse events NDA Submitted – Q1 2025 Completed 600 mg QD OBJECTIVES NPM1-m, KMT2A-r, Other NPM1-m or KMT2A-r NPM1-m NPM1-m Completed CR/CRh, complete remission with full or partial hematologic recovery; KMT2A-r, KMT2A-rearranged; MRD, measurable residual disease; NPM1-m, NPM1-mutated; QD, once daily.

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![Slide 9](g917067ex99_1s9g1.jpg)

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 (%) Ziftomenib RP2D 600 mg QD Phase 2 (N=92) Pooled Phase 1b/2 (N=112) Median age, yrs (range) 69 (33–84) 69 (22–86) 18–64 yrs 33 (36) 42 (38) ≥65 yrs 59 (64) 70 (63) Female 49 (53) 63 (56) Race White 75 (82) 88 (79) Non-White 17 (18) 24 (21) Region United States/Canada 45 (49) 57 (51) Europe 47 (51) 55 (49) ECOG PS 0 27 (29) 30 (27) 1 49 (53) 63 (56) 2 16 (17) 19 (17) Bone marrow aspirate blasts %, median (range) 39.5 (0.5–98) 44.0 (0.5–98) n (%) Ziftomenib RP2D 600 mg QD Phase 2 (N=92) Pooled Phase 1b/2 (N=112) Co-mutations, n/Na&nbsp;&nbsp;&nbsp;&nbsp; FLT3-ITD 38/84 (45) 43/102 (42) FLT3-TKD 9/84 (11) 11/102 (11) IDH1-m 10/80 (13) 13/97 (13) IDH2-m 16/18 (20) 22/96 (23) Median prior therapies (range) 2 (1–7) 2 (1–7) 1 32 (35) 37 (33) 2 30 (33) 37 (33) ≥3 30 (33) 38 (34) Prior HSCT 22 (24) 26 (23) Prior venetoclax 54 (59) 67 (60) Prior menin inhibitor 1 (1) 1 (1) Baseline characteristics were similar between the phase 2 and pooled phase 1b/2 populations aAmong patients with available co-mutation data at baseline.

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![Slide 10](g917067ex99_1s10g1.jpg)

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 (25) Overall Response CR CRh CRi/CRp MLFS PR Othera 30 (33) 13 (14) 8 (9) 3 (3) 5 (5) 1 (1) 62 (67) 39 (35) 20 (18) 8 (7) 4 (4) 6 (5) 1 (1) 73 (65) Median Duration of Response, months (95% CI) CR/CRh CRc ORR 3.7 (1.9–NE) 4.6 (2.8–11.4) 4.6 (2.8–11.4) 3.7 (1.9–7.7) 5.1 (2.8–8.1) 4.6 (3.6–7.7) Restricted Mean Duration of Responseb, months (95% CI) CR/CRh CRc ORR 4.3 (3.1–5.6) 5.9 (4.0–7.7) 5.9 (4.4–7.5) 5.2 (3.6–6.7) 6.4 (4.6–8.1) 6.5 (4.9–8.1) MRD negativity, n/Nc (%) 12/19 (63) 17/26 (65) Median time to CR/CRh: 2.8 months (range, 1.0 – 15.0) Median time to ORR: 1.9 months (range, 0.8 – 3.7) Data cutoff: Dec 20, 2024. 1. Smith CC et al. Blood Adv. 2022;6(7):2144-55. CR, complete remission; CRc, composite complete remission; CRh, complete remission with partial hematologic recovery; CRi, CR with incomplete hematologic recovery; CRp, CR with incomplete platelet recovery; MLFS, morphologic leukemia free state; MRD, measurable residual disease; ORR, overall response rate; PR, partial response; QD, once daily; RP2D, recommended phase 2 dose. aStable disease/no response/clinical benefit/progressive disease/not evaluable. bDefined as the expected duration of response (area under the Kaplan-Meier curve, up to the time point when ≥10% of patients remain at risk). cAmong CR/CRh responders evaluated for MRD (centrally tested). \*Based on primary analysis data cut (Oct 28, 2024).

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![Slide 11](g917067ex99_1s11g1.jpg)

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 duplication; TKD, tyrosine kinase domain. Comparable CR/CRh rates across pre-specified subgroups, regardless of prior HSCT, venetoclax, or FLT3/IDH co-mutations

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![Slide 12](g917067ex99_1s12g1.jpg)

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 (%) 2/10 (20) 95% CIb 3–56 Post-baseline transfusion of red blood cells Transfusion conversion (TD to TI) ratea, n/N (%) 18/75 (24) 95% CIb 15–35 Maintenance of transfusion independence (TI to TI) ratec, n/N (%) 2/17 (12) 95% CIb 2–36 Post-baseline transfusion of platelets Transfusion conversion (TD to TI) ratea, n/N (%) 12/71 (17) 95% CIb 9–28 Maintenance of transfusion independence (TI to TI) ratec, n/N (%) 8/21 (38) 95% CIb 18–62 aTransfusion conversion rate was defined as the number of patients who were TD at baseline but became TI post-baseline (ie, n) divided by the total number of patients who were TD at baseline. bCI was calculated using the exact method based on binomial distribution. CTransfusion maintenance rate was defined as the number of patients who were TI at baseline and remained TI post-baseline (ie, n) divided by the total number of patients who were TI at baseline. Post-baseline transfusion period was defined as the 29 days post-first dose of ziftomenib until last dose prior to any new anti-cancer treatment (HSCT). Data cutoff: Dec 20, 2024. HSCT, hematopoietic stem cell transplantation; QD, once daily; RP2D, recommended phase 2 dose; TD, transfusion dependent; TI, transfusion independent.

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![Slide 13](g917067ex99_1s13g1.jpg)

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 months (95% CI, 3.8–8.4) Note: 24 patients remain alive on-study, with 9 patients on-treatment

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![Slide 14](g917067ex99_1s14g1.jpg)

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. Ziftomenib was well tolerated, with a safety profile consistent with previous studies,1,2 including: Low rates of ziftomenib-related myelosuppression No clinically significant QTc prolongation: 3 (3%)\* patients: 1 Gr2, 2 Gr3 (all investigator-assessed) Differentiation syndrome: 15 (13%) Gr3; no Gr4–5 events Treatment-Emergent AEs in ≥20% of All Patients Event, n (%) Ziftomenib RP2D 600 mg QD Phase 2 (N=92) Pooled Phase 1b/2 (N=112) Any Grade Grade ≥3 Any Grade Grade ≥3 Any AE 92 (100) 86 (93) 112 (100) 105 (94) Hematologic AEs Anemia 20 (22) 18 (20) 25 (22) 23 (21) Febrile neutropenia 24 (26) 24 (26) 25 (22) 25 (22) Thrombocytopenia 18 (20) 18 (20) 22 (20) 22 (20) Nonhematologic AEs Diarrhea 27 (29) 1 (1) 36 (32) 5 (4) Nausea 23 (25) 1 (1) 31 (28) 1 (1) Hypokalemia 22 (24) 12 (13) 29 (26) 13 (12) Differentiation syndrome 23 (25) 14 (15)a 27 (24) 15 (13)a Pruritus 21 (23) 0 26 (23) 0 Peripheral edema 23 (25) 0 25 (22) 0 Pneumonia 19 (21) 13 (14) 24 (21) 17 (15) aNo patients had Grade 4–5 differentiation syndrome. \*All 3 patients were on additional medications associated with QTc prolongation: 2 patients had electrolyte abnormalities and 1 patient had prior diagnosis of atrial fibrillation.

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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. Ziftomenib-related AEs in ≥5% of All Patients Event, n (%) Ziftomenib RP2D 600 mg QD Phase 2 (N=92) Pooled Phase 1b/2 (N=112) Any Grade Grade ≥3 Any Grade Grade ≥3 Any ziftomenib-related AE 64 (70) 37 (40) 77 (69) 45 (40) Hematologic AEs Anemia 5 (5) 5 (5) 6 (5) 6 (5) Neutropenia 6 (7) 6 (7) 6 (5) 6 (5) Nonhematologic AEs Differentiation syndrome 22 (24) 14 (15)a 26 (23) 15 (13)a Pruritus 15 (16) 0 16 (14) 0 Nausea 8 (9) 0 13 (12) 0 Diarrhea 8 (9) 0 10 (9) 2 (2) Alanine aminotransferase increased 6 (7) 2 (2) 7 (6) 2 (2) Decreased appetite 5 (5) 0 6 (5) 0 Ziftomenib was well tolerated, with a safety profile consistent with previous studies,1,2 including: Low rates of ziftomenib-related myelosuppression No clinically significant QTc prolongation: 3 (3%)\* patients: 1 Gr2, 2 Gr3 (all investigator-assessed) Differentiation syndrome: 15 (13%) Gr3; no Gr4–5 events 3% discontinuations due ziftomenib-related AEs aNo patients had Grade 4–5 differentiation syndrome. \*All 3 patients were on additional medications associated with QTc prolongation: 2 patients had electrolyte abnormalities and 1 patient had prior diagnosis of atrial fibrillation.

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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 Ziftomenib monotherapy was well tolerated with a safety profile consistent with previous studies Low rates of ziftomenib-related myelosuppression 3% ziftomenib-related discontinuations No clinically significant QTc prolongation Differentiation syndrome was managed with protocol-specified mitigation strategies; no Grade 4–5 DS events NDA submitted for ziftomenib monotherapy as a new potential treatment option for adult patients with R/R NPM1-m AML Ziftomenib combination studies are currently ongoing in both newly diagnosed and R/R AML (KOMET-007, KOMET-008)

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ZIFTOMENIB GLOBAL DEVELOPMENT PLAN Mollie Leoni, M.D. – Chief Medical Officer, Kura Oncology

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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-001 R/R NPM1-m AML KOMET-007 R/R Zifto + Ven/Aza R/R Zifto + Ven KOMET-007 1L Zifto + Ven / Aza 1L Zifto + 7+3 Investigator-/Company-Sponsored Studies Combinations, Pediatric studies and Post-HSCT Maintenance KOMET-017-IC 1L Zifto + 7+3 1L Placebo + 7+3 KOMET-017-NIC 1L Zifto + Ven / Aza 1L Placebo + Ven/Aza RELAPSED / REFRACTORY KOMET-008 R/R Zifto + FLAG-IDA R/R Zifto + LDAC R/R Zifto + gilteritinib Intensive (IC) or Non-Intensive (NIC) Tx Transplant/ No Transplant Post-Transplant Maintenance KOMET-007 1L Zifto + Ven/Aza 1L Zifto + 7+3 KOMET-017-IC 1L Zifto + 7+3 1L Placebo + 7+3 KOMET-017-NIC 1L Zifto + Ven/Aza 1L Placebo + Ven/Aza \*FIT IC = patients eligible for induction chemotherapy; UNFIT NIC = patients eligible for non-intensive chemotherapy

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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 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 Nadminiti21, 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 EHA2025 Congress June 12–15 \| Milan, Italy 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 S136

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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 Primary endpoints CR OS Ziftomenib Venetoclax + Azacitidine Placebo Venetoclax + Azacitidine R 1:1 KOMET-017-IC: Intensive therapy – Ziftomenib and 7+3 chemotherapy Patients NPM1-m or KMT2A-r AMLa FLT3 wildtype or ITD ratio of <0.05b Age ≥18 yrs ECOG PS 0–2 Primary endpoints CR MRD-negativity (NPM1-m only) EFS Arm C Arm A Arm B Ziftomenib 7+3 Induction(s) Consolidation Placebo 7+3 Induction(s) Consolidation Ziftomenib 7+3 Induction(s) Consolidation Placebo R 1:1:1 aExcluding partial tandem duplication. bUnless ineligible for FLT3-targeted therapy. Expected to start in 2H 2025 (see EHA 2025 Trial-in-Progress abstract) CR, complete remission; ECOG PS, Eastern Cooperative Oncology Group performance status; EFS, event-free survival; MRD, measurable residual disease; OS, overall survival

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ZIFTOMENIB MARKET OPPORTUNITY IN R/R NPM1-m AML Brian Powl – Chief Commercial Officer, Kura Oncology

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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] myelosuppression is definitely a high advantage" "[S]o the minute that this drug hits the market, everyone's going to want to know about using it in triplet" "The thing that makes me excited about it is that of those responders, the majority are MRD-negative . . . " "once a day, safer, you don't have to worry about QT prolongation" Ziftomenib is differentiated on safety and tolerability, efficacy in ven exposed, combinability, and convenience Kura Oncology Ziftomenib Advisory Board – May 9, 2025; data on file "a 16.4-month median survival for the people [in the R/R setting] who respond, that is actually really good and longer than I would have expected…"

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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 modifications when combined with CYP3A4i EFFICACY 23% CR/CRh rate in salvage patients with / without prior ven Median OS of 16.4 months among responders in the R/R NPM1-m setting Achievement of transfusion independence Kura Oncology Ziftomenib Advisory Board – May 9, 2025; data on file Ziftomenib is differentiated on safety and tolerability, efficacy in ven exposed, combinability, and convenience

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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 <10% Combination of encouraging clinical activity and safety in a once-daily oral medication supports an attractive R/R opportunity AML, acute myeloid leukemia; CR, complete response. 1. Issa GC, et al. Blood Cancer J. 2021;11(9):162. 2. Bertoli S, et al. Blood. 2018;132(suppl 1):2802. 3. Hubmann M, et al. Haematologica. 2014;99(8):1317-1325. 4. SEER Cancer Stat Facts: Acute Myeloid Leukemia. National Cancer Institute. Bethesda, MD. Accessed March 14, 2023. https://seer.cancer.gov/statfacts/html/amyl.html. 5 Issa G, et al. Blood Adv. 2023;7(6):933-942. 6. DeWolf et. al, Blood 2020; 136 (9) 1023-1032. $36-40k /month Analog pricing, including for recently approved product $350-400M/yr U.S. market opportunity in R/R NPM1-m AML Potential for safe and well-tolerated targeted Tx to support sustained treatment ~6 mo Duration of Treatment

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CORPORATE OVERVIEW Troy Wilson, Ph.D., J.D. – Chief Executive Officer, Kura Oncology

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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 study in R/R NPM1-m AML; Priority review and PDUFA action date November 30, 2025 Kyowa Kirin collaboration funds expansive AML development program through 1L U.S. commercialization Target indications include HNSCC, lung, colorectal, pancreatic and renal cell carcinomas Farnesyl Transferase Inhibitors (FTIs) in Large Solid Tumor Indications FTIs may overcome innate and adaptive resistance to PI3Ka inhibitors, KRAS inhibitors and tyrosine kinase inhibitors (TKIs) in certain indications Clinical data for KO-2806 and tipifarnib in combination expected in 2H 2025 Additional Therapeutic Opportunities for Menin Inhibitors Encouraging preclinical data for menin inhibitors in type 2 diabetes; development candidate nomination anticipated mid-2025 Phase 1 study of ziftomenib + imatinib in gastrointestinal stromal tumors (GIST) underway; additional potential $1B opportunity

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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-intensive AML ü NDA submission for ziftomenib in R/R NPM1-m AML ü Present topline data from KOMET-001 Phase 2 registration-directed trial in R/R NPM1-m AML ü Initiate KOMET-015 Phase 1 trial of ziftomenib in combination with imatinib in patients with advanced GIST ü Present preliminary clinical data from KOMET-007 Phase 1b trial in 1L intensive AML 2Q 2025 Initiate KOMET-017 Phase 3 registration-enabling trials in 1L NPM1-m and KMT2A-r intensive and non-intensive AML 2H 2025 Present preliminary clinical data from Phase 1b expansion of KOMET-007 in 1L non-intensive AML 2H 2025 KO-2806 / tipifarnib Initiate one or more expansion cohorts in combination with cabozantinib in RCC 2H 2025 Present preliminary clinical data from FIT-001 trial for KO-2806 as monotherapy and combo with cabozantinib in RCC 2H 2025 Present clinical data from the KURRENT-HN trial of tipifarnib in combo with alpelisib in PIK3CA-dependent HNSCC 2H 2025 Next-gen Menin Nominate a development candidate for next-generation menin inhibitor program for diabetes Mid-2025

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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 ziftomenib AML program to potential commercialization in frontline combinations in potential near-term milestones, including launch of ziftomenib in the monotherapy R/R setting $703.2M $375M

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QUESTIONS & ANSWERS

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THANK YOU Our goal is to develop transformative therapies to extend and improve the lives of patients with cancer