What guidance did Kura Oncology's management provide for the next earnings period?

Did Kura Oncology beat or miss consensus estimates last quarter?

What is Kura Oncology's latest dividend and current dividend yield?

What factors drove the changes in Kura Oncology's revenue and profit?

What does Kura Oncology do and what are its main business segments?

What were the key takeaways from Kura Oncology's earnings call?

What is the market's earnings forecast for Kura Oncology next quarter?

What is the revenue and EPS growth rate for Kura Oncology year over year?

- **Zifduminib Regulatory Momentum**: On track for November 30 FDA decision; COMET-001 data shows 70%+ CR/MRD negativity in relapsed AML.
- **Frontline Expansion**: COMET-017 trials enrolling 150+ sites, targeting 50% of AML cases with Zifduminib combinations.
- **Financial Strength**: $609M pro forma cash; $420M in near-term milestones from Kyowa Kirin partnership.
- **Commercial Readiness**: 100+ field reps trained; launch materials and limited distribution network ready post-approval.
- **FTI Growth Potential**: Darlefarinib combinations show 33-50% ORR in renal cancer; tebufarinib + alpelisib achieves 47% ORR in head/neck cancer.

**【CEO Summary Section】**
- **Zifduminib Regulatory Progress**: FDA review on track for November 30, 2025 PDUFA date. COMET-001 study data highlights differentiated benefit-risk profile, with high CR and MRD negativity rates in relapsed/refractory NPM1-mutated AML.
- **Frontline Expansion**: COMET-017 phase 3 trials evaluating Zifduminib in combination with 7+3 and venetoclax-azacitidine chemotherapy. Enrollment progressing across 150+ global sites, targeting 50% of incident AML cases.
- **Commercial Readiness**: Launch team (Kura + Kyowa Kirin) trained and ready for immediate execution post-approval. Payer engagement and limited distribution network fully aligned.
- **FTI Portfolio Update**: Darlefarinib combination trials with cabozantinib in renal cell carcinoma show 33-50% ORR; tebufarinib + alpelisib in head and neck cancer achieves 47% ORR. Potential to address >200,000 U.S. patients annually.

**【CFO Financial Commentary】**
- **Q3 2025 Financials**: Collaboration revenue $20.8M (vs. $0 in 2024). R&D expenses $67.9M (+63%), G&A $32.8M (+80%). Net loss $74.1M (vs. $54.4M). Pro forma cash $609.7M, supporting operations through 2027.
- **Milestone Progress**: Received $105M in 2025, including $30M for COMET-017 phase 3启动. Total near-term milestones: $420M from Kyowa Kirin partnership.

**【Q&A Highlights】**
- **Market Share Strategy**: Emphasize Zifduminib's safety (no QTc prolongation black box warning) and convenience (once-daily oral). Target 4,000+ hematologists, 70% in academic centers. NCCN guideline submission planned post-approval.
- **FDA Engagement**: Open and constructive interactions; no disruptions noted despite CDER changes. ASH 2025 presentations will feature updated data on Zifduminib combinations in frontline and relapsed settings.
- **Launch Execution**: Joint Kura-Kyowa Kirin field team of 100+ reps trained and ready. Pre-approval payer exchanges complete; limited distribution network operational.
- **Safety Profile**: Zifduminib's lack of QTc prolongation risk differentiates from competitors. ASH data will highlight durability and subgroup analyses in frontline settings.

Kura Oncology, Inc. (KURA) Q3 2025 Earnings Call Transcript

- **FDA Priority Review**: Ziftomenib NDA for relapsed/refractory NPM1-mutant AML granted with November 2025 PDUFA date.
- **Clinical Success**: 23% CR/CRh rate in KOMET-001 trial, 63% MRD-negative responders.
- **Frontline Expansion**: Phase III trials targeting 50% of AML patients now in start-up.
- **Commercial Strength**: $630M cash, Kyowa Kirin partnership, and 20+ year-experienced sales team.
- **Market Potential**: $7B+ annual U.S. opportunity in frontline AML.
- **FTI Innovation**: Three ESMO abstracts highlight KO-2806 in RCC, solid tumors, and head/neck cancer.

**【CEO Summary Section】**
- FDA accepted the NDA for ziftomenib in relapsed/refractory NPM1-mutant AML with a PDUFA date of November 30, 2025, under priority review.
- Positive monotherapy data from KOMET-001 trial showed a CR/CRh rate of 23% in relapsed/refractory NPM1-mutant AML, with 63% of responders MRD-negative.
- Frontline development acceleration: Phase III trials (KOMET-017-IC and KOMET-017-NIC) are in study start-up, targeting up to 50% of AML patients.
- Commercial readiness: Building sales force, manufacturing capacity, and launch planning with Kyowa Kirin.
- Cash position of $630.7 million as of Q2 2025, with potential $375 million in near-term milestones from Kyowa Kirin collaboration.

**【CFO Financial Commentary】**
- Q2 2025 revenue: $15.3 million from Kyowa Kirin collaboration (vs. $0 in Q2 2024).
- R&D expenses: $62.8 million (up 58% YoY) due to ziftomenib combination trials.
- G&A expenses: $25.2 million (up 51% YoY) driven by pre-commercial activities.
- Net loss: $66.1 million (vs. $50.8 million in Q2 2024), with cash runway into 2027.

**【Commercial Readiness Section】**
- Sales force recruitment complete: 20+ years average hem/onc experience, working alongside Kyowa Kirin's U.S. field team.
- Estimated addressable market for relapsed/refractory NPM1-mutant AML: $350-400 million annually.
- Frontline AML potential: 50% of newly diagnosed AML patients (22,000/year) could benefit, with $7 billion+ annual U.S. market opportunity.
- Patient support programs and distribution network being finalized for rapid launch.

**【Q&A Highlights】**
- Regulatory interactions: Constructive and aligned with PDUFA timeline; no major issues identified.
- Menin inhibitor competition: Ziftomenib's safety, efficacy, and convenience position it as best-in-class; early KOL feedback positive.
- Phase III trial confidence: Single-protocol design for KOMET-017 reduces site burden, with strong enrollment expectations.
- FTI program expansion: Three ESMO abstracts highlight KO-2806 in RCC, RAS-mutant solid tumors, and head/neck cancer; virtual data event planned for October.
- Janssen's bleximenib: Kura's head start in Phase III trials and enrollment momentum expected to maintain competitive advantage.


Kura Oncology, Inc. (KURA) Q2 2025 Earnings Call Transcript

- **NDA Milestone Achieved**: Ziftomenib NDA submitted with $45M Kyowa Kirin payment, solidifying $703M cash position.
- **Pipeline Momentum**: ASCO oral presentation of Phase 2 AML data; GIST combination trial dosing begins.
- **Financial Stability**: Q1 2025 revenue $14.1M; $375M Kyowa Kirin milestones secure frontline development.
- **Competitive Edge**: Ziftomenib's safety profile and Kyowa Kirin partnership position for NPM1-mutant AML leadership.

**【CEO Opening Remarks】**
- **NDA Submission Milestone**: Ziftomenib NDA submitted for relapsed/refractory NPM1-mutant AML, with $45 million milestone payment from Kyowa Kirin.
- **Cash Position**: Pro forma cash of $703.2 million (including Kyowa Kirin milestone) supports frontline AML development and pipeline advancement.
- **Pipeline Progress**: Ziftomenib Phase 2 data accepted for ASCO oral presentation; GIST combination trial dosing initiated.

**【CFO Financial Highlights】**
- **Revenue**: Q1 2025 collaboration revenue $14.1 million (vs. $0 in Q1 2024).
- **Expenses**: R&D $56 million (vs. $36.3M), G&A $22.8M (vs. $18.2M), driven by clinical trial expansion.
- **Net Loss**: $57.4 million (vs. $49.5M), with $7.8M non-cash share-based compensation.
- **Cash**: $658.2 million as of March 31, 2025; Kyowa Kirin collaboration provides $375 million in near-term milestones.

**【Q&A Key Takeaways】**
- **Market Competition**: CEO emphasizes ziftomenib's safety/tolerability profile and Kyowa Kirin's commercial resources to compete in NPM1-mutant AML.
- **Clinical Trials**: Phase 3 frontline AML trials (KOMET-017) expected to initiate H2 2025; GIST combination trial shows potential to prevent imatinib resistance.
- **FTI Program**: KO-2806 combination data with cabozantinib in RCC anticipated H2 2025; monotherapy RAS mutation data also planned.
- **Regulatory Outlook**: FDA collaboration continues; priority review requested for ziftomenib NDA, with PDUFA date expected Q2 2025.

Kura Oncology (KURA)-1 May 25-2025 Q1 Earnings call transcript

- **Revenue Growth Accelerates**: 12% YoY to $12.5B, driven by cloud and AI solutions.
- **AI Investment Pivot**: $2B+ into generative AI for 20%+ CAGR.
- **Profitability Boost**: Operating margin up to 22.5%, free cash flow +15% YoY.
- **Q4 Outlook Strong**: 10-12% growth, EPS $2.20-2.30.

**【CEO Opening Remarks】**
- Q3 revenue reached $12.5B, up 12% YoY, driven by cloud services and enterprise software solutions.
- Announced $2B investment in generative AI over next 3 years, targeting 20%+ CAGR in AI-related products.
- Highlighted North America market recovery (+18% YoY) offsetting EMEA slowdown (-2% YoY).

**【CFO Financial Highlights】**
- GAAP net income: $1.8B (14% YoY growth)
- Non-GAAP EPS: $2.15 (vs. $2.05 consensus)
- Operating margin improved to 22.5% (from 20.3% YoY) due to cost optimization.
- Free cash flow: $3.2B, up 15% YoY.

**【Q&A Key Takeaways】**
1. **AI Product Pipeline**: 5 new generative AI tools launching Q4, targeting enterprise customers.
2. **China Market Strategy**: Seeking partnerships with local firms to comply with data regulations.
3. **Competitive Response**: Allocating 30% of R&D budget to counter OpenAI's advancements.
4. **Guidance for Q4**: Revenue $13.2-13.6B (10-12% YoY), EPS $2.20-2.30

Kura Oncology (KURA)-26 Feb 25-2024 Q4 Earnings call transcript

Kura Oncology (KURA)-7 Nov 24-2024 Q3 Earnings call transcript

Kura Oncology (KURA)-8 Aug 24-2024 Q2 Earnings call transcript

Kura Oncology (KURA)-2 May 24-2024 Q1 Earnings call transcript

Kura Oncology, Inc. (KURA) Q4 2023 Earnings Call Transcript

Kura Oncology (KURA)-3 Aug 23-2023 Q2 Earnings call transcript

Kura Oncology (KURA)-10 May 23-2023 Q1 Earnings call transcript

Kura Oncology (KURA)-23 Feb 23-2022 Q4 Earnings call transcript

Kura Oncology (KURA)-3 Nov 22-2022 Q3 Earnings call transcript

Kura Oncology (KURA)-3 Aug 22-2022 Q2 Earnings call transcript

Kura Oncology (KURA)-5 May 22-2022 Q1 Earnings call transcript

Kura Oncology (KURA)-25 Feb 22-2021 Q4 Earnings call transcript

Kura Oncology (KURA)-7 Nov 21-2021 Q3 Earnings call transcript

Kura Oncology (KURA)-7 Aug 21-2021 Q2 Earnings call transcript

Kura Oncology (KURA)-9 May 21-2021 Q1 Earnings call transcript

Kura Oncology (KURA)-24 Feb 21-2020 Q4 Earnings call transcript

Kura Oncology (KURA)-7 Nov 20-2020 Q3 Earnings call transcript

Kura Oncology (KURA)-9 Aug 20-2020 Q2 Earnings call transcript

Kura Oncology (KURA)-4 May 20-2020 Q1 Earnings call transcript

Kura Oncology (KURA)-25 Feb 20-2019 Q4 Earnings call transcript

Kura Oncology (KURA)-9 Nov 19-2019 Q3 Earnings call transcript

Kura Oncology (KURA)-2 Aug 19-2019 Q2 Earnings call transcript

Kura Oncology (KURA)-7 May 19-2019 Q1 Earnings call transcript

Kura Oncology (KURA)-5 Mar 19-2018 Q4 Earnings call transcript

Kura Oncology (KURA)-5 Nov 18-2018 Q3 Earnings call transcript

Kura Oncology (KURA)-6 Aug 18-2018 Q2 Earnings call transcript

Kura Oncology (KURA)-14 May 18-2018 Q1 Earnings call transcript

Kura Oncology (KURA)-12 Mar 18-2017 Q4 Earnings call transcript

Kura Oncology (KURA)-12 Nov 17-2017 Q3 Earnings call transcript

KURA

KURA fundamentals

Earnings Call

You can ask Aime