California Biotech's Trial Shows Encouraging Results
Research Report

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Disclosures for H.C. Wainwright & Co., Kura Oncology Inc., June 20, 2025

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H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Joseph Pantginis, Ph.D., Lander Egaña Gorroño, Ph.D., Joshua Korsen, Ph.D., Matthew Keller, Ph.D. and Sara Nik, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Kura Oncology, Inc. and Syndax Pharmaceuticals, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of May 31, 2025 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Kura Oncology, Inc. and Syndax Pharmaceuticals, Inc.. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report. The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The Firm or its affiliates did not receive compensation from Kura Oncology, Inc. and Syndax Pharmaceuticals, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in Kura Oncology, Inc. and Syndax Pharmaceuticals, Inc. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report. H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

On June 20, 2025, H.C. Wainwright analysts Dr. Joseph Pantginis, Dr. Joshua Korsen, Dr. Lander Egaña Gorroño, Dr. Matthew Keller, and Dr. Sara Nik reiterated a Buy rating on Kura Oncology Inc. (KURA:NASDAQ) with a US$40.00 price target, representing 560% upside from the share price at the time of the report of US$6.06.

The analysts cited encouraging KOMET-007 trial results supporting ziftomenib's benefit-risk profile for first-line acute myeloid leukemia and upcoming Phase 3 trial initiation in the second half of 2025.

Recent Clinical Developments and Trial Results

Kura Oncology, Inc. presented updated results from the Phase 1a/b KOMET-007 clinical trial at the European Hematology Association conference, evaluating ziftomenib in combination with cytarabine/daunorubicin (7+3) in newly diagnosed NPM1-mutant and KMT2A-rearranged AML patients. Among the efficacy-evaluable population of 71 patients, 92% achieved composite complete remission, with 93% for NPM1-mutant patients and 89% for KMT2A-rearranged patients. Complete remission was achieved by 80% of patients overall, with 84% for NPM1-mutant and 74% for KMT2A-rearranged patients.

The safety profile remained favorable, with treatment-related adverse events of Grade 3 or higher occurring in 10% or more of patients limited to febrile neutropenia, decreased platelet count, anemia, and decreased neutrophil count. The analysts noted these were "similar to AEs reported for newly diagnosed AML patients treated with 7+3 alone," suggesting no additive toxicity attributable to ziftomenib. One case of differentiation syndrome in a KMT2A-rearranged patient was successfully managed, and no dose-limiting toxicities were observed.

Regulatory Progress and Commercial Timeline

The FDA accepted Kura's New Drug Application for ziftomenib with Priority Review for relapsed or refractory NPM1-mutant AML, setting a PDUFA target action date of November 30, 2025. The NDA submission is based on results from the registration-enabling Phase 2 KOMET-001 trial, which demonstrated a complete remission plus complete remission with partial hematologic recovery rate of 23% among 92 relapsed or refractory NPM1-mutant AML patients, meeting the primary endpoint versus a 12% historical control rate.

The analysts emphasized that ziftomenib "has the potential to become the first FDA-approved menin inhibitor specifically for adult patients with R/R AML harboring an NPM1 mutation, a genetically defined subset with limited treatment options and historically poor outcomes."

Strategic Pipeline Development

Kura has received regulatory approval to initiate Phase 3 KOMET-017 trials in the second half of 2025, encompassing two independent studies: KOMET-017-NIC evaluating ziftomenib with venetoclax plus azacytidine in newly diagnosed NPM1-mutant patients unfit for intensive chemotherapy, and KOMET-017-IC assessing ziftomenib with induction chemotherapy in newly diagnosed NPM1-mutant and KMT2A-rearranged AML patients.

Beyond AML, the company continues advancing KO-2806, a next-generation farnesyl transferase inhibitor in RAS-mutated solid tumors, and tipifarnib in combination studies for head and neck squamous cell carcinoma. The company is also developing a novel menin inhibitor candidate for diabetes applications.

Financial Position and Valuation

Kura maintains a strong financial position with US$703.2 million in pro forma cash following the second quarter 2025 NDA submission milestone payment, providing runway for continued development activities. The company reported total debt of US$9.2 million and cash per share of US$8.12 based on 86.6 million shares outstanding.

The analysts' valuation model assigns 79% contribution to ziftomenib for the AML opportunity, 5% to KO-2806 for solid tumors, and 16% to tipifarnib/alpelisib for head and neck cancer. Potential upside exists from diabetes applications for ziftomenib, broader AML use cases, and future business development opportunities.

Risk Factors and Investment Outlook

Key risks include potential failed or inconclusive clinical trials and the company's ability to secure adequate funding for continued development. However, the analysts remain optimistic about the upcoming catalysts, including Phase 3 trial initiations in the second half of 2025, preliminary combination data, and potential approval in the fourth quarter of 2025.

With a current enterprise value of negative US$169 million due to the substantial cash position and market capitalization of US$525 million, Kura represents a well-funded clinical-stage opportunity with multiple value inflection points approaching across its pipeline programs.