1Q: ASCO MUT Dataset Plus WT PDUFA Anchor The Near-Term Setup

研报英文原文证据摘录

1Q: ASCO MUT Dataset Plus WT PDUFA Anchor The Near-Term Setup

ensitive study to VIKTORIA-2

w/ topline data by 2030 -- results from endocrine-resistant population are expected by end of

2028. We believe expanding to the ET-sensitive population can significantly expand the mkt oppty

and view it as somewhat de-risked, given the known safety profile from the V-1 ph.III along w/ ph.Ib

49mo mPFS shown in the sensitive population.

V-2 now includes 2 separate ph.IIIs w/ independent SAPs and ITT primary analyses, w/ Study 1

enrolling ~440 endocrine-resistant pts and Study 2 enrolling ~740 endocrine-sensitive 1L pts;

primary endpt is PFS by BICR, and mgmt noted they aligned the amended design via a Type B

FDA mtg.

CELC has now hired/onboarded the oncology sales specialists; payer plus strategic-account

outreach has been ongoing for ~1 yr w/ mgmt noting formal payer review begins post-approval,

but early feedback has been encouraging. On go-to-mkt, mgmt plans for broad outreach across

community+academic centers, w/ efficacy consistently coming through as the #1 driver in doc mkt

research, and wkly IV admin showing up as a (-)ve in a minority of responses (<10%).

Finally, co formally started subq development as a lifecycle mgmt program (1st patent app filed

in 4Q25). Mgmt framed the roadmap as formulation optimization → scale/stability → PK work to

map equivalence to IV → likely a clinical equivalence study, w/ the longer-term goal of having subq

available on a timeline that supports future multi-yr treatment settings.

Maury Raycroft, Ph.D. * | Equity Analyst

Financials: Adding 1L endocrine-sensitive to our revenue build w/ peak sales of $1.4B. PT to $160 (212) 323-3990 | mraycroft@jefferies.com

(vs prior $138). Cash $387M w/ runway through 2027; OPEX $50.5M (vs our est $53.1M).