Executive Summary

Kura reported first-time collaboration revenue of $53.883M in Q4 2024, driving a materially narrower net loss of $(19.217)M and $(0.22) EPS vs $(42.786)M and $(0.55) EPS in Q4 2023 as Kyowa Kirin payments began to flow .
Strategic inflection: ziftomenib’s registrational KOMET-001 achieved its primary endpoint; management plans to submit the NDA for R/R NPM1-mutant AML in Q2 2025 and present topline data in Q2 2025 .
Frontline pathway de-risked: FDA and EMA aligned on using MRD-negative CR (IC) and CR (non-IC) as primary endpoints to enable potential U.S. accelerated approvals in Phase 3 KOMET-017; topline MRD-negative CR readout from KOMET-017-IC anticipated in 2028 .
Balance sheet strengthened to fund execution: cash and investments rose to $727.395M, including the $330M Kyowa Kirin upfront; runway into 2027, and collaboration funding expected to support ziftomenib through U.S. commercialization in frontline combinations .

What Went Well and What Went Wrong

What Went Well

KOMET-001 hit its primary endpoint in R/R NPM1-mutant AML; NDA submission planned for Q2 2025, with topline data also expected in Q2 2025 .
Global regulatory alignment achieved for Phase 3 frontline program (KOMET-017); FDA/EMA alignment on MRD-negative CR (IC) and CR (non-IC) as primary endpoints for potential U.S. accelerated approvals .
Combination data momentum: in 1L adverse-risk AML (7+3), 91% CR overall (100% NPM1-m, 83% KMT2A-r); high MRD-negativity rates and tolerability supported 600 mg expansion dosing; ven/aza cohorts showed activity even in venetoclax-experienced patients .

Management quote: “We’re poised to submit our first NDA for ziftomenib... We’ve reached alignment with FDA and EMA... allowing MRD-negative CR and CR as primary endpoints respectively” .

What Went Wrong

Phase 3 start timing appeared to drift: KOMET-017 initiation moved from “mid-2025” (ASH update) to “second half of 2025” in the Q4 update, indicating modest timing risk in getting studies live globally .
No traditional product revenue; Q4 top-line was collaboration-driven. While positive for cash, it doesn’t yet validate commercial demand—execution risk remains until NDA approval and launch .
OpEx rose as the company scaled for registrational and commercial readiness: Q4 R&D up to $52.267M (vs $32.533M y/y) and G&A to $24.071M (vs $14.229M y/y), potentially elevating burn if milestones/royalties slip .

Financial Results

Income statement and balance sheet summary (oldest → newest)

Metric	Q4 2023	Q2 2024	Q3 2024	Q4 2024
Collaboration Revenue ($USD Millions)	$0.000	N/A	N/A	$53.883
Research & Development Expense ($USD Millions)	$32.533	$39.727	$41.705	$52.267
General & Administrative Expense ($USD Millions)	$14.229	$16.677	$18.179	$24.071
Total Operating Expenses ($USD Millions)	$46.762	$56.404	$59.884	$76.338
Other Income, net ($USD Millions)	$3.976	$5.567	$5.480	$5.256
Income Tax Expense ($USD Millions)	$0.000	N/A	N/A	$(2.018)
Net Loss ($USD Millions)	$(42.786)	$(50.837)	$(54.404)	$(19.217)
Net Loss per Share, basic & diluted ($)	$(0.55)	$(0.59)	$(0.63)	$(0.22)
Weighted Avg Shares (Millions)	77.337	86.635	86.950	87.136
Cash, Cash Equivalents & ST Investments ($USD Millions)	$423.957	$491.519	$455.297	$727.395

Notes:

Collaboration revenue inception in Q4 2024 reflects the Kyowa Kirin agreement; Q4 2024 revenue is $53.883M vs $0.0M in Q4 2023 .
CFO reiterated the same Q4 figures on the call and cash runway into 2027 .

Segment breakdown: Not applicable (no commercial segments; revenue from collaboration) .

KPIs:

Cash runway: into 2027; with anticipated collaboration funding expected to support ziftomenib AML program through U.S. commercialization in frontline combination setting .
Cash balance: $727.395M at 12/31/24, including $330M upfront from Kyowa Kirin .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
KOMET-001 topline (R/R NPM1-m)	Timing	“Early 2025”	“Q2 2025”	Narrowed timing window
NDA submission (R/R NPM1-m)	Timing	Submit “within a few months” post-topline; aiming for H2 2025 approval window	Submit NDA in Q2 2025	Clarified/anchored submission date
KOMET-017 Phase 3 start (frontline IC & NIC)	Start	“Mid-2025” (ASH update)	“Second half of 2025”	Pushed later
KOMET-015 GIST PoC start	Start	1H 2025	1H 2025	Maintained
Cash runway	Horizon	Into 2027	Into 2027; plus collaboration support through 1L commercialization	Maintained; strengthened via collaboration
KO-2806 program milestones	Timing	MTD by end-2024; RCC expansion 1H 2025	RCC expansion 1H 2025; multiple 2H 2025 data readouts	Maintained expansion; specified 2H data timing

Earnings Call Themes & Trends

Topic	Q2 2024 (Prev-2)	Q3 2024 (Prev-1)	Q4 2024 (Current)	Trend
Regulatory path (frontline) & MRD	MRD-negative CR discussed as potential “upside”; base case survival endpoints; planning health authority discussions	Similar framing; base case survival, MRD-negativity as upside; preparing for endpoints dialogue	Alignment reached with FDA/EMA; MRD-negative CR (IC) and CR (non-IC) accepted as primary endpoints for U.S. accelerated approval; IC topline 2028	Clear de-risking; pathway defined
Commercial duration & market	—	Frontline “on-therapy” durability emerging; high on-study continuation in 7+3 cohorts	Management expects 18–24 months duration potential; sees $7B U.S. market for frontline menin inhibitors	Bullish duration narrative building
Kyowa Kirin collaboration	—	—	$330M upfront; up to ~$1.2B milestones; 50/50 U.S. profit share; ex-U.S. rights to Kyowa Kirin; funding plan to commercialization	Funding partner secured
GIST expansion	IND cleared; PoC study expected 1H 2025	Strong preclinical synergy with imatinib; PoC 1H 2025	On track to initiate KOMET-015 in 1H 2025; mgmt sees ~$1B potential	Execution on schedule
FTIs (KO-2806/tipifarnib)	Initiated combinations; adagrasib, cabozantinib; KURRENT-HN enrolling	Safety improves with higher ziftomenib dose; continued FTI combo development	First KO-2806 data and KURRENT-HN data expected 2H 2025; mgmt outlines combo rationale and tolerability focus	Toward human efficacy signals
Diabetes menin inhibitor	Preclinical data at ADA; plan to nominate next-gen candidate early 2025	Next-gen program continues; nomination 1H 2025	Candidate nomination mid-2025; exploring partnering structures for non-oncology	Strategic option, not near-term focus

Management Commentary

Prepared remarks: “We’re preparing to commercialize ziftomenib as a potentially best-in-class menin inhibitor… We’ve reached alignment with FDA on potential pathways for accelerated approval in the U.S. in both the intensive and non-intensive frontline settings” (Troy Wilson) .
On timing: “We feel comfortable… we think we can have top-line results for that accelerated approval endpoint in 2028” (frontline IC) .
On frontline durability: “We are seeing good prolonged use… more significant than what we initially thought” (Mollie Leoni); menin inhibitors could support 18–24 months treatment duration, underpinning market opportunity (Brian Powl) .
Press release highlight: “KOMET-001 registrational trial… achieved its primary endpoint… anticipate submitting an NDA in the second quarter of 2025” (Troy Wilson) .

Q&A Highlights

Frontline Phase 3 timing: Management guided to topline MRD-negative CR in 2028 for KOMET-017-IC, with details on size/power to come as studies go live; accelerated vs survival endpoints clarified by region (FDA vs EMA) .
NDA readiness: Pre-NDA meeting completed; alignment achieved; submission targeted for Q2 2025 with no notable outstanding issues beyond final clinical dataset .
Treatment duration/usage: Early data suggest prolonged on-therapy duration in frontline (both IC and NIC), bolstering commercial thesis; management frames 18–24 months as credible .
Trial design (transplant imbalance): Multiple sensitivity analyses incorporated; trial sized and powered anticipating transplant dynamics across arms .
Competitive differentiation: Emphasis on combinability, once-daily dosing, lack of QT prolongation, no myelosuppression, and ease of use vs peers; physicians aim to treat early/in combination and keep patients on therapy .
FTI strategy: Safety/tolerability is gating factor for combos; seeking unexpected activity in early-phase signals with KO-2806 and tipifarnib combinations across KRAS, TKIs, PI3K pathways .

Estimates Context

Wall Street consensus (S&P Global) for Q4 2024 EPS and revenue could not be retrieved due to data-access limits in this session; as a result, we cannot quantify an EPS or revenue beat/miss vs consensus at this time. If needed, we can refresh and reconcile against S&P consensus in a follow-up once access is restored.
Notably, Q4 revenue was collaboration-driven ($53.883M), with no product revenue; net loss per share improved to $(0.22) from $(0.63) in Q3 and $(0.55) in Q4 2023 .

Key Takeaways for Investors

Regulatory de-risking is meaningful: FDA/EMA alignment on MRD-based endpoints in frontline provides a credible accelerated pathway; IC topline MRD readout guided for 2028—keep focus on study initiation/activation in 2H 2025 .
Near-term catalyst path: KOMET-001 topline and NDA submission in Q2 2025; watch ASCO for data alignment with the NDA package and any commentary on label-enabling durability/safety .
Funding and strategic partner in place: $727M cash plus Kyowa Kirin economics (50/50 U.S. profit share; ex-U.S. royalties) support the commercialization build; runway into 2027 reduces financing overhang through key milestones .
Frontline commercial thesis: Management sees 18–24 months on-therapy potential and a multi-billion U.S. market for menin inhibitors; durability signals from 7+3 and ven/aza cohorts are strategically important .
Watch for execution on starts: KOMET-017 moved to 2H 2025 initiation; site readiness and global activation pace are the next gating factors for bringing forward the 2028 MRD topline .
Pipeline optionality: GIST PoC in 1H 2025 could open a novel solid tumor beachhead; FTI readouts in 2H 2025 provide additional value levers; diabetes remains a medium-term strategic option .
Stock drivers: 2025 data cadence (KOMET-001 topline, NDA filing, KOMET-007 updates), clarity on Phase 3 starts, and any early signs of regulatory momentum or commercial readiness are likely to dictate near-term trading.

Kura Oncology, Inc. (KURA)·Q4 2024 Earnings Summary