On November 10, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for cancer, reported third quarter 2026 financial results and provided a corporate update.

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"KOMZIFTI delivered strong commercial performance this quarter, with 53% sequential revenue growth, a 30% increase in new patients starts, and continued majority share of new patient starts," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We believe these results demonstrate the growing commercial potential of KOMZIFTI and provide a strong foundation as we advance ziftomenib into the substantially larger frontline AML opportunity. We have also reached FDA alignment on our planned registrational study of darlifarnib in HRAS-mutant salivary gland cancer, providing a potential path to our second product approval as we continue to pursue broader opportunities with combinations in solid tumors. With a strengthened financial position, we believe we are well positioned to execute on these priorities and build two differentiated precision oncology franchises."

KOMZIFTI 3Q 2026 Commercial Performance

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$13.9 million in net product revenue, a 53% increase from 2Q 2026
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Approximately 150 new patient starts (NPS), a 30% increase from 2Q 2026
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More than 420 total prescriptions (TRx), including repeat prescriptions, a 65% increase from 2Q 2026
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KOMZIFTI maintained a majority share of NPS in the relapsed or refractory (R/R) NPM1-m AML menin inhibitor class

Advancing Two Precision Oncology Franchises

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Advancing the Phase 3 KOMET-017 frontline registrational program with ziftomenib-based combinations in newly diagnosed AML; site activation and patient enrollment continue across studies for patients eligible for intensive and non-intensive chemotherapy.
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Alignment reached with the U.S. Food and Drug Administration (FDA) on the design of a planned darlifarnib single-arm monotherapy registrational study in patients with HRAS-mutant salivary gland cancer (SGC) to support potential approval.
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An August publication in Blood described the discovery and preclinical characterization of ziftomenib, including its potency, selectivity, menin binding properties, and activity against certain resistance-associated mutations. These findings provide a preclinical rationale for continued evaluation of ziftomenib across genetically defined acute leukemias.

Strategic Financing

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Entered into a strategic financing agreement with affiliates of Oberland Capital providing up to $300 million in potential funding, including up to $275 million in debt financing and $25 million in equity investments, subject to applicable conditions. The financing is expected to support continued investment in KOMZIFTI, ziftomenib development, and darlifarnib monotherapy registrational and combination studies.
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Received $55 million at closing, comprised of $50 million in debt funding, before fees, and a $5 million equity investment. Additional funding is available through company-option and milestone-based tranches, and an additional tranche of funding is available upon mutual agreement.
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The debt financing agreement has a seven-year term. Each term loan advanced under the agreement will bear interest at a rate between 6.95% and 8.95%, with 50% of interest capitalized during the first three years following the applicable advance date. The financing also provides for a single-digit royalty tied to U.S. KOMZIFTI net sales, capped at 20% of the aggregate principal amount of term loans advanced under the agreement.

Other Corporate Highlights

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Jennifer Fulk joined Kura in September 2026 as Chief Financial Officer. Ms. Fulk brings more than 20 years of financial and operating leadership experience spanning biopharmaceuticals, public companies, and high-growth businesses. After more than 15 years at Eli Lilly and Company, she served in a series of senior finance and operating leadership roles at Talkspace, 120Water, and, most recently, Soleno Therapeutics.
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Launched Caspian Therapeutics, Inc., a separately financed company established to advance menin inhibitors for diabetes and cardiometabolic diseases. Caspian completed a $50 million financing led by BVF Partners with participation from T1D Fund, Invus, Montanova, Eli Lilly and Company, Kura Oncology, and other investors.

Upcoming Milestones and Priorities

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KOMZIFTI Commercial Priorities
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Expand the number of prescribing accounts.
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Increase repeat prescribing within existing accounts.
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Drive consistent quarter-over-quarter growth.
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Strengthen leadership in the R/R NPM1-mutated AML menin inhibitor market.

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Ziftomenib Development Milestones
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Initial topline results from the frontline KOMET-017 registrational program are anticipated in 2028, representing a key milestone in evaluating the potential to expand ziftomenib into newly diagnosed AML.
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Eight ziftomenib abstracts will be presented at the 2026 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, including:
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FLT3 inhibitor combinations: Two oral presentations will report encouraging preliminary results for ziftomenib plus quizartinib and 7+3 intensive chemotherapy in newly diagnosed NPM1-m/FLT3-ITD+ AML (KOMET-007) and ziftomenib plus gilteritinib in R/R NPM1/FLT3 co-mutated AML (KOMET-008).

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Longer-term frontline outcomes: A KOMET-007 poster will report updated durability, survival, and MRD outcomes with ziftomenib plus venetoclax and azacitidine, supporting continued evaluation of the ziftomenib-based low-intensity combination in the global randomized phase 3 study in newly diagnosed NPM1-m AML.

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Additional molecular subtypes: A KOMET-001 poster will provide data supporting prospective evaluation of ziftomenib-based therapy in molecularly defined AML populations most likely to benefit from menin inhibitor therapy beyond the current US FDA-approved indication. A separate oral presentation will demonstrate findings supporting further investigation of ziftomenib in additional molecularly defined AML populations.

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Pediatric development: An oral presentation from Blood Cancer United and Princess Maxima Center’s Phase 1 PedAL trial with ziftomenib plus fludarabine and cytarabine in pediatric patients with R/R acute leukemias will describe early efficacy signals in a heavily pre-treated population, including patients with previous revumenib exposure.

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Darlifarnib Registration and Combination Milestones
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Initiate the planned single-arm monotherapy registrational study of darlifarnib in approximately 40 HRAS-mutant SGC patients in 1H 2027.
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Complete enrollment in the randomized Phase 1b portion of FIT-001 in evaluating darlifarnib plus cabozantinib in cabozantinib-naïve clear cell renal carcinoma in 1H 2027 and report initial clinical data in 2H 2027.
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Initiate a Phase 1 study of darlifarnib plus daraxonrasib in second-line or later KRAS-mutated pancreatic ductal adenocarcinoma in 1H 2027, with a goal to provide preliminary data in 2H 2027.

Third Quarter 2026 Financial Results

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Net product revenue: $13.9 million, compared to none for 3Q 2025
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Collaboration revenue: $8.9 million, compared to $20.8 million for 3Q 2025
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R&D expenses: $66.9 million, compared to $67.9 million for 3Q 2025
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SG&A expenses: $30.2 million, compared to $32.8 million for 3Q 2025
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Net loss: $70.2 million, compared to $74.1 million for 3Q 2025. Net loss includes $8.2 million in non-cash, share-based compensation expense compared to $11.0 million for the same period in 2025.

As of September 30, 2026, Kura had $492.1 million in cash, cash equivalents and short-term investments, compared with $667.2 million as of December 31, 2025.

Kura’s financial position, supported by anticipated collaboration milestone payments from Kyowa Kirin totaling $180 million and additional conditional financing capacity under its agreement with Oberland Capital, is expected to enable continued investment in the KOMZIFTI commercial launch, the Phase 3 KOMET-017 frontline AML program and the advancement of darlifarnib toward first potential registration and broader development in solid tumors. Based on its current operating plan, Kura expects its financial resources to support operations beyond anticipated initial topline results from the pivotal Phase 3 KOMET-017 study in 2028.

Kura has updated its 2026 collaboration revenue guidance to $40 million to $45 million for 2026 and is maintaining guidance of $90 million to $110 million in each of 2027 and 2028. This guidance reflects non-cash accounting recognition as Kura fulfills performance obligations under its agreement with Kyowa Kirin and does not reflect the timing of cash receipts.

Conference Call and Webcast

Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, November 10, 2026, to discuss financial results and to provide a corporate update. A live webcast and archived replay of the event will be available on the Investors section of the Company’s website at www.kuraoncology.com.

(Press release, Kura Oncology, NOV 10, 2026, View Source [SID1234674562])