Kura（KURA）：ASCO25 Menin抑制剂在复发难治性NPM1突变急性髓系白血病关键数据细节令人印象深刻

2024A2025E0.053.9438.6NMNM11.9x1.5x(1.73)0.73 2026E185.7NM3.5x(1.81) Roger Song, MD, CFA * | Equity Analyst(617) 342-7955 | rsong@jefferies.comLiang Cheng, Ph.D. * | Equity Associate+1 (617) 342-7896 | lcheng1@jefferies.comFiona Jia, Ph.D. * | Equity Associate+1 (617) 342-7942 | fjia@jefferies.comCha Cha Yang, MS, MBA * | Equity Associate+1 (857) 330-5772 | cyang2@jefferies.com Chart 1 - Baselines.Source: Company ReportsChart 2 - Efficacy: Topline.Source: Company ReportsChart 3 - Efficacy: Overall Survival.Source: Company ReportsChart 4 - Efficacy: sub-group analysis.Source: Company ReportsPlease see important disclosure information on pages 8 - 13 of this report.This report is intended for Jefferies clients only. Unauthorized distribution is prohibited. Chart 5 - Efficacy: Transfusion Benefit.Source: Company ReportsChart 6 - Safety.Source: Company ReportsPlease see important disclosure information on pages 8 - 13 of this report.This report is intended for Jefferies clients only. Unauthorized distribution is prohibited. The Long View: KuraInvestment Thesis / Where We DifferKura is a clinical-stage biotech focusing on precision medicine for cancertreatment. Lead ziftomenib has shown very promising Ph1 monotx data inr/r AML and combo data in 1L and r/r AML, supported by differentiatedpharmacological properties, potentially generating a multi-$B opportunity.Base Case,$28, +344%•Ziftomenib in AML US peak-adjusted sales ~$2.7B (65-85% POS)•Additional pipeline value of $350M•No credit to ex-US sales•DCF-based PT: $28Sustainability MattersTop Material Issue(s): 1) Employee Engagement, Diversity, & Inclusion.To create products, carry outclinical trials in a diverse patient population, comply with regulations, and market new items, companies inthe sector need highly qualified workers. If KURA can recruit and retain skilled personnel, it may be betterpositioned to safeguard and grow shareholder value.2)Product Quality & Safety.Upon completion ofcontrolled clinical studies and receipt of regulatory approval, information on product safety might becomeavailable that requires subject companies such as KURA to react to the financial effects of recalls andother challenges.Company Target(s): 1)Aspires to maintain the highest ethical standards.2)Pledged to provideemployees with opportunities for equity ownership and developmental programs and committed tobuilding a racially and ethnically diverse workforce.Qs to Mgmt:How is Kura Oncology planning to improve human capital development efforts to supportemployee engagement, diversity and Inclusion?2)How will Kura Oncology improve the ability ofshareholders to influence board composition?Please see important disclosure information on pages 8 - 13 of this report.This report is intended for Jefferies clients only. Unauthorized distribution is prohibited. Upside Scenario,$34, +440%•Ziftomenib in AML US peak-adjusted sales ~$3.5B (85-100% POS)•Additional pipeline value of $350M•No credit to ex-US sales•DCF-based PT: $34 Downside Scenario,$2, -68%•Ziftomenib failed in AML•No additional pipeline value•No credit to ex-US sales•Cash-based PT: $2 (25% of pro forma cash)Catalysts•EHA25: KOMET-001 detailed results in NPM1mR/R AML•Mid'25:candidate nomination for menininhibitor in diabetes•EHA25/ ASH25: KOMET-007 Ph1b data updateat 600mg at a Medical Meeting•2H25:Zifto+SoC combo pivotal start infrontline AML pts (KOMET-017)•2H25: KO-2806 monotx and combo initial data•2H25: KURRENT-HN Ph1b data•~'26: KOMET-008 Ph1 data•~'26: Zifto+Imatinib in GIST Solid Tumors PoCStudy initial data 4 Commercial Opportunity:. r/r NPM1m AML market is estimated at ~$350–400M, w/ ~20% ofpatients primary refractory and ~50% relapsing after CR. <10% of r/r AML patients alive at 5yrs,underscoring the unmet need. Zifto’s profile (oral QD, no cardiac monitoring, low myelosuppression)positionsit well for community adoption,especially in real world older patients often w/comorbidities (cardiac medications that may not mix well w/ other menin comps). Launch isexpected in 4Q25, upon approval. KURA is closely tracking competitor experience and is well-capitalized with $703M pro forma cash and up to $375M in near-term milestones to support launch,expected 4Q25.Pipeline Next Steps:Pivotal Ph3 1L combo trial KOMET-017 to initiate 2H25 w/ two arms: zifto +ven/aza in "Unfit" pts and zifto + 7+3 in "Fit" pts. KOMET-007 Ph1b update at EHA will provide moremature data on zifto + 7+3 (600mg), with some pts on therapy >47wks. Mgmt reiterated that bestvalue for zifto lies in 1L, where early intervention can suppress clonal evolution and minimize meninresistance. Co also initiating KOMET-008 arm for r/r FLT3+ AML to explore earlier intervention withzifto combos.More tidbits from ASCO:•MRD(-) status correlated w/ improved OS (MRD–: >12 mo vs MRD+: ~9 mo) and supports MRDas endpoint•UK OPTIMISE study cited as precedent showing that NPM1m patients achieving MRD(-) after2 cycles of chemo may not require allo-HSCT—supporting zifto