Kura Oncology Reports First Quarter 2026 Financial Results

On May 12, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for cancer, reported first quarter 2026 financial results and provided a corporate update.

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"In its first full quarter of commercial availability, KOMZIFTI generated $5.8 million in net revenue, with early launch dynamics indicating growing physician adoption and utilization patterns based on product profile. We believe these early signals support KOMZIFTI’s potential to become the leading therapy in relapsed/refractory NPM1-mutant AML," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Supported by a robust clinical development program designed to establish it as a broadly combinable backbone across the AML treatment continuum, and with multiple data readouts expected this year across frontline and combination settings, we are well positioned for the next phase of growth."

Recent Developments

KOMZIFTI Launch Performance (First Quarter 2026)

KOMZIFTI delivered a strong first full quarter of commercial performance, with early indicators supporting adoption and continued momentum:

$5.8 million in net product revenue in the first full quarter of commercial sales

85 new patient starts and 157 total prescriptions, reflective of both uptake and repeat use

> 93% payer coverage achieved, with favorable positioning across plans covering more than 12 million lives
Early market dynamics, including repeat prescribing, expanding use across treatment settings, initial combination use and instances of switching from other menin inhibitors, indicate growing physician adoption based on product profile.

Advancing Ziftomenib Across the Acute Myeloid Leukemia (AML) Treatment Continuum

Kura continues to execute on its strategy to establish ziftomenib as a broadly combinable backbone therapy across AML:

KOMET-017 (Phase 3 Frontline Program): Ongoing site activation and patient enrollment for both studies across global sites with strong early progress

KOMET-008 (FLT3 Relapsed/Refractory [R/R] Population): Ongoing enrollment evaluating ziftomenib combined with gilteritinib in patients with R/R AML harboring FLT3-ITD/NPM1 co-mutations

KOMET-007 (FLT3 Frontline Population): Ongoing enrollment evaluating ziftomenib combined with quizartinib plus cytarabine and daunorubicin (7+3) induction chemotherapy in patients with newly diagnosed AML harboring FLT3-ITD/NPM1 co-mutations

Japanese Registrational Trial: First patient dosed in Phase 2 trial (jRCT2031250550) for treatment of R/R NPM1-m AML, representing a significant step toward bringing a potential new treatment option to patients in Japan
Multiple clinical data readouts expected in 2026 across combination regimens and treatment settings, supporting ziftomenib’s potential use broadly across the AML landscape.

Solid Tumor Pipeline Progress

Kura continues to advance darlifarnib as a novel approach to overcoming resistance in targeted therapy:

Proof-of-mechanism data for darlifarnib in combination with cabozantinib: At the 2026 International Kidney Cancer Symposium: Europe (IKCS) conference, Kura presented proof-of-mechanism data for darlifarnib in combination with cabozantinib in patients with clear cell renal cell carcinoma previously treated with cabozantinib

The data support darlifarnib’s potential to overcome resistance and resensitize tumors to VEGF TKI therapy, with
44% objective response rate (ORR)
94% disease control rate (DCR)
Tumor shrinkage in 75% of patients
FIT-001 Phase 1b dose expansion: Enrollment is ongoing
2026 Commercial Priorities and Anticipated Development Milestones

Kura expects multiple value-driving catalysts in 2026 across commercial development and clinical development:

KOMZIFTI Commercial Execution

Drive clear differentiation within the menin inhibitor class
Deliver sustained quarter-over-quarter growth in revenue and adoption
Establish leading class share in R/R NPM1-m AML
Ziftomenib – Frontline AML

Present updated results for ziftomenib / 7+3 combination in frontline NPM1-m/KMT2A-r AML (KOMET-007) in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in June 2026
Ziftomenib – Relapsed/Refractory AML

Publish data for ziftomenib plus venetoclax + azacitidine in R/R NPM1-m AML (1H 2026)
Present preliminary KOMET-008 data for ziftomenib and gilteritinib combination in R/R NPM1-m/FLT3-m AML (2H 2026)
Ziftomenib and Menin Inhibition – Expansion Beyond AML

Continue enrollment of KOMET-015 evaluating ziftomenib + imatinib in gastrointestinal stromal tumors (GIST)
Progress preclinical development of next-generation menin inhibitor for use in other solid tumors
Darlifarnib

Present preliminary clinical data for darlifarnib plus adagrasib in KRASG12C-mutated solid tumors at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting in May 2026
Present updated Phase 1a data with the first report of long-term follow-up for darlifarnib plus cabozantinib in advanced RCC (2H 2026)
KO-7246 (Next-Generation Menin Inhibitor)

Advance KO-7246 into IND-enabling studies for diabetes and cardiometabolic disease
Present additional preclinical data for menin inhibitors in diabetes
First Quarter 2026 Financial Results

Net product revenue: $5.8 million, compared to none for Q1 2025
Collaboration revenue: $12.5 million, compared to $14.1 million for Q1 2025
R&D expenses: $65.3 million, compared to $56.0 million for Q1 2025, primarily driven by advancement of ziftomenib combination trials, including KOMET-017
SG&A expenses: $31.6 million, compared to $22.8 million for Q1 2025, reflecting commercialization-related investments
Net loss: $73.3 million, compared to $57.4 million for Q1 2025. Net loss includes $8.4 million in non-cash, share-based compensation expense compared to $7.8 million for the same period in 2025.
As of March 31, 2026, Kura had $580.8 million in cash, cash equivalents and short-term investments, compared to $667.2 million as of December 31, 2025.

The Company believes its cash, cash equivalents and short-term investments as of March 31, 2026, when combined with $180 million in anticipated payments under the collaboration agreement with Kyowa Kirin, will be sufficient to fund the ziftomenib AML program through the topline results from the first pivotal Phase 3 KOMET-017 frontline trial, anticipated in 2028.

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, May 12, 2026, to discuss financial results and to provide a corporate update. A live webcast and archived replay of the event will be available here or from the Investors section of the Company’s website at www.kuraoncology.com.

(Press release, Kura Oncology, MAY 12, 2026, View Source [SID1234665544])

Kura Oncology and Kyowa Kirin to Present Updated Frontline Ziftomenib / 7+3 Combination Data at EHA 2026 Congress

On May 12, 2026 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported that updated results from the frontline arm of the Phase 1 KOMET-007 (NCT05735184) clinical trial evaluating ziftomenib in combination with cytarabine plus daunorubicin (7+3) in patients with newly diagnosed NPM1-mutant (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML) have been accepted for an oral presentation on Sunday, June 14, 2026, at the upcoming 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Stockholm, Sweden.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The oral presentation will highlight updated results in 99 patients with newly diagnosed NPM1-m or KMT2A-r AML treated with ziftomenib 600 mg once daily in combination with 7+3. These results represent one of the largest datasets reported to date for the evaluation of a menin inhibitor in combination with intensive chemotherapy in frontline AML.

As of the abstract data cut-off on January 16, 2026:

High response rates across both molecular subtypes
Composite complete response (CRc) rates of 96% (47/49) for NPM1-m and 90% (45/50) for KMT2A-r AML
Deep molecular responses
Measurable residual disease (MRD)-negativity rates among CRc responders of 83% (39/47) for NPM1-m and 82% (32/39) for KMT2A-r AML
Encouraging durability with extended follow-up
Median follow-up of 14.9 months (NPM1-m) and 9.3 months (KMT2A-r)
Median duration of CRc not reached (NPM1-m) and 11.2 months (KMT2A-r)
Consistent and manageable safety profile
Safety profile consistent across the NPM1-m and KMT2A-r groups with no new safety signals observed with long-term treatment
Updated analyses with longer median follow-up, central MRD assessment, durability outcomes, and deeper characterization of safety and hematologic recovery will be included at the time of the oral presentation

"With nearly 100 patients treated as well as extended follow-up, ziftomenib in combination with 7+3 continues to demonstrate consistently high response rates, deep MRD negativity, and encouraging durability across genetically defined AML subsets," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "These data support our belief ziftomenib has potential to serve as a foundational backbone for frontline AML therapy, and we are advancing this regimen in our ongoing Phase 3 registrational program."

In addition to the oral presentation, abstracts for the KOMET-007 and KOMET-017 trials have been accepted for a poster presentation and online publication, respectively. Details are provided below and are available on the EHA (Free EHA Whitepaper)web.org website.

EHA 2026 Presentation Details

Title: Ziftomenib combined with intensive induction (7+3) for newly diagnosed NPM1-m or KMT2A-r acute myeloid leukemia (AML): Long-term results from the KOMET-007 trial
Session: s446 Novel treatments in AML
Date and Time: Sunday, June 14; 11:00-12:15 CEST
Location: Nobel Hall
Publication Number: S130

Title: Exposure-response analysis of ziftomenib combined with venetoclax/azacitidine or cytarabine/daunorubicin in newly diagnosed and relapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia
Session: Poster Session 1
Date and Time: Friday, June 12; 18:45-19:45 CEST
Location: Poster Hall
Publication Number: PF537

Title: Registrational Phase 3 studies of ziftomenib in combination with nonintensive or intensive chemotherapy for newly diagnosed NPM1-m or KMT2A-r acute myeloid leukemia (AML): The KOMET-017 trial
Location: Online Publication
Date and Time: Tuesday, May 12; 9:30 AM ET/15:30 CEST
Publication Number: PB2766

Copies of the presentations will be available on Kura’s website at www.kuraoncology.com/pipeline/publications following presentation at the meeting.

Virtual Investor Event
Kura will host a webcast and conference call on June 12, 2026, at 8:00 am ET / 5:00 am PT, featuring management and a clinical investigator from the KOMET-007 study. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.

(Press release, Kura Oncology, MAY 12, 2026, View Source [SID1234665543])

Kura Oncology and Kyowa Kirin to Present Updated Frontline Ziftomenib / 7+3 Combination Data at EHA 2026 Congress

On May 12, 2026 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported that updated results from the frontline arm of the Phase 1 KOMET-007 (NCT05735184) clinical trial evaluating ziftomenib in combination with cytarabine plus daunorubicin (7+3) in patients with newly diagnosed NPM1-mutant (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML) have been accepted for an oral presentation on Sunday, June 14, 2026, at the upcoming 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Stockholm, Sweden.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The oral presentation will highlight updated results in 99 patients with newly diagnosed NPM1-m or KMT2A-r AML treated with ziftomenib 600 mg once daily in combination with 7+3. These results represent one of the largest datasets reported to date for the evaluation of a menin inhibitor in combination with intensive chemotherapy in frontline AML.

As of the abstract data cut-off on January 16, 2026:

High response rates across both molecular subtypes
Composite complete response (CRc) rates of 96% (47/49) for NPM1-m and 90% (45/50) for KMT2A-r AML
Deep molecular responses
Measurable residual disease (MRD)-negativity rates among CRc responders of 83% (39/47) for NPM1-m and 82% (32/39) for KMT2A-r AML
Encouraging durability with extended follow-up
Median follow-up of 14.9 months (NPM1-m) and 9.3 months (KMT2A-r)
Median duration of CRc not reached (NPM1-m) and 11.2 months (KMT2A-r)
Consistent and manageable safety profile
Safety profile consistent across the NPM1-m and KMT2A-r groups with no new safety signals observed with long-term treatment
Updated analyses with longer median follow-up, central MRD assessment, durability outcomes, and deeper characterization of safety and hematologic recovery will be included at the time of the oral presentation

"With nearly 100 patients treated as well as extended follow-up, ziftomenib in combination with 7+3 continues to demonstrate consistently high response rates, deep MRD negativity, and encouraging durability across genetically defined AML subsets," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "These data support our belief ziftomenib has potential to serve as a foundational backbone for frontline AML therapy, and we are advancing this regimen in our ongoing Phase 3 registrational program."

In addition to the oral presentation, abstracts for the KOMET-007 and KOMET-017 trials have been accepted for a poster presentation and online publication, respectively. Details are provided below and are available on the EHA (Free EHA Whitepaper)web.org website.

EHA 2026 Presentation Details

Title: Ziftomenib combined with intensive induction (7+3) for newly diagnosed NPM1-m or KMT2A-r acute myeloid leukemia (AML): Long-term results from the KOMET-007 trial
Session: s446 Novel treatments in AML
Date and Time: Sunday, June 14; 11:00-12:15 CEST
Location: Nobel Hall
Publication Number: S130

Title: Exposure-response analysis of ziftomenib combined with venetoclax/azacitidine or cytarabine/daunorubicin in newly diagnosed and relapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia
Session: Poster Session 1
Date and Time: Friday, June 12; 18:45-19:45 CEST
Location: Poster Hall
Publication Number: PF537

Title: Registrational Phase 3 studies of ziftomenib in combination with nonintensive or intensive chemotherapy for newly diagnosed NPM1-m or KMT2A-r acute myeloid leukemia (AML): The KOMET-017 trial
Location: Online Publication
Date and Time: Tuesday, May 12; 9:30 AM ET/15:30 CEST
Publication Number: PB2766

Copies of the presentations will be available on Kura’s website at www.kuraoncology.com/pipeline/publications following presentation at the meeting.

Virtual Investor Event
Kura will host a webcast and conference call on June 12, 2026, at 8:00 am ET / 5:00 am PT, featuring management and a clinical investigator from the KOMET-007 study. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.

(Press release, Kura Oncology, MAY 12, 2026, View Source [SID1234665543])

Kura Oncology and Kyowa Kirin to Present Updated Frontline Ziftomenib / 7+3 Combination Data at EHA 2026 Congress

On May 12, 2026 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported that updated results from the frontline arm of the Phase 1 KOMET-007 (NCT05735184) clinical trial evaluating ziftomenib in combination with cytarabine plus daunorubicin (7+3) in patients with newly diagnosed NPM1-mutant (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML) have been accepted for an oral presentation on Sunday, June 14, 2026, at the upcoming 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Stockholm, Sweden.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The oral presentation will highlight updated results in 99 patients with newly diagnosed NPM1-m or KMT2A-r AML treated with ziftomenib 600 mg once daily in combination with 7+3. These results represent one of the largest datasets reported to date for the evaluation of a menin inhibitor in combination with intensive chemotherapy in frontline AML.

As of the abstract data cut-off on January 16, 2026:

High response rates across both molecular subtypes
Composite complete response (CRc) rates of 96% (47/49) for NPM1-m and 90% (45/50) for KMT2A-r AML
Deep molecular responses
Measurable residual disease (MRD)-negativity rates among CRc responders of 83% (39/47) for NPM1-m and 82% (32/39) for KMT2A-r AML
Encouraging durability with extended follow-up
Median follow-up of 14.9 months (NPM1-m) and 9.3 months (KMT2A-r)
Median duration of CRc not reached (NPM1-m) and 11.2 months (KMT2A-r)
Consistent and manageable safety profile
Safety profile consistent across the NPM1-m and KMT2A-r groups with no new safety signals observed with long-term treatment
Updated analyses with longer median follow-up, central MRD assessment, durability outcomes, and deeper characterization of safety and hematologic recovery will be included at the time of the oral presentation

"With nearly 100 patients treated as well as extended follow-up, ziftomenib in combination with 7+3 continues to demonstrate consistently high response rates, deep MRD negativity, and encouraging durability across genetically defined AML subsets," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "These data support our belief ziftomenib has potential to serve as a foundational backbone for frontline AML therapy, and we are advancing this regimen in our ongoing Phase 3 registrational program."

In addition to the oral presentation, abstracts for the KOMET-007 and KOMET-017 trials have been accepted for a poster presentation and online publication, respectively. Details are provided below and are available on the EHA (Free EHA Whitepaper)web.org website.

EHA 2026 Presentation Details

Title: Ziftomenib combined with intensive induction (7+3) for newly diagnosed NPM1-m or KMT2A-r acute myeloid leukemia (AML): Long-term results from the KOMET-007 trial
Session: s446 Novel treatments in AML
Date and Time: Sunday, June 14; 11:00-12:15 CEST
Location: Nobel Hall
Publication Number: S130

Title: Exposure-response analysis of ziftomenib combined with venetoclax/azacitidine or cytarabine/daunorubicin in newly diagnosed and relapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia
Session: Poster Session 1
Date and Time: Friday, June 12; 18:45-19:45 CEST
Location: Poster Hall
Publication Number: PF537

Title: Registrational Phase 3 studies of ziftomenib in combination with nonintensive or intensive chemotherapy for newly diagnosed NPM1-m or KMT2A-r acute myeloid leukemia (AML): The KOMET-017 trial
Location: Online Publication
Date and Time: Tuesday, May 12; 9:30 AM ET/15:30 CEST
Publication Number: PB2766

Copies of the presentations will be available on Kura’s website at www.kuraoncology.com/pipeline/publications following presentation at the meeting.

Virtual Investor Event
Kura will host a webcast and conference call on June 12, 2026, at 8:00 am ET / 5:00 am PT, featuring management and a clinical investigator from the KOMET-007 study. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.

(Press release, Kura Oncology, MAY 12, 2026, View Source [SID1234665543])

Karyopharm to Participate at Upcoming Investor Conferences

On May 12, 2026 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company’s senior management team will participate in the following investor conferences in May:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

H.C. Wainwright 4th Annual BioConnect Investor Conference
Format: Fireside chat
Date: Tuesday, May 19, 2026
Time: 9:00 a.m. ET

RBC 2026 Global Healthcare Conference
Format: Fireside chat
Date: Tuesday, May 19, 2026
Time: 3:35 p.m. ET

A live webcast of the fireside chats can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source, and will be available for replay following the event.

(Press release, Karyopharm, MAY 12, 2026, View Source [SID1234665542])