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The call conveyed strong clinical momentum (notably KT-621 and KT-579), significant balance sheet strength (raised ~ $1B; $1.6B year-end cash) and multiple high-value collaborations, all supporting an ambitious development plan. Headwinds include elevated R&D spend (adjusted cash R&D +16% QoQ), limited current revenue, translational/measurement complexity for IRF5, and multi-year timelines to pivotal readouts and potential approvals. Overall, the positives—compelling early clinical data, IND/Phase I starts, partner validation and a multi-year cash runway—outweigh the noted operational and timing risks.
The company guided to an active 2026 development cadence: complete enrollment in the KT‑621 Phase IIb atopic dermatitis BROADEN2 trial (≈200 adults/adolescents; primary endpoint: % change in EASI at 16 weeks) this year with top‑line data by mid‑2027, and continue the BREADTH Phase IIb asthma trial (≈264 adults; primary endpoint: change in pre‑bronchodilator FEV1 at 12 weeks) after dosing the first patient in Feb 2026 and sharing data in late‑2027 — collectively generating data in roughly 500 patients next year and rolling AD patients into a 52‑week OLE; KT‑579 (IRF5 degrader) has initiated a SAD/MAD Phase I in healthy volunteers with data expected H2 2026 (target ~90% IRF5 knockdown and ~50–80% reductions in ex‑vivo TLR7/8/9 biomarkers) and a rapid move to lupus POC planned thereafter; partnered programs include Gilead (received $40M upfront; up to $750M milestones, including $45M on option) and Sanofi (KT‑485 HV Phase I expected this year; up to ~ $1B in milestones), while financials support these plans — 2025 fundraising near $1B, year‑end cash $1.6B (runway into 2029), Q4 collaboration revenue $2.9M, Q4 R&D $83.8M (noncash SBC $7.6M; adjusted cash R&D $76.2M, +16% vs prior quarter), and Q4 G&A $16.9M (noncash SBC $6.9M; adjusted cash G&A $10M, +1% vs prior quarter) — and the company expects to name at least one new program in H2 2026.
Phase I healthy volunteer and Phase Ib BroADen data showed robust STAT6 degradation, favorable safety/tolerability and meaningful reductions in Type 2 biomarkers (TARC, Eotaxin-3) and lung FeNO; clinical endpoints (EASI, Pruritus NRS, IGA, SCORAD, PROs) were in line with or numerically exceeded published dupilumab data at 4 weeks.
Two parallel Phase IIb dose-ranging, placebo-controlled trials launched: BROADEN2 (AD, ~200 adults/adolescents, primary endpoint % change in EASI at 16 weeks; enrollment expected complete by end-2026; topline mid-2027) and BREADTH (asthma, ~264 adults with eosinophilic asthma, primary endpoint change in pre-bronchodilator FEV1 at 12 weeks; data expected late-2027). Combined expectation: ~500 patients generating data next year.
Completed 6–9 month GLP toxicology studies in rats and nonhuman primates for KT-621 with no adverse findings reported; long-term treatment data being collected via a 52-week open-label extension for AD patients.
KT-579 IND cleared and dosing initiated in a Phase I single/multiple ascending dose healthy volunteer study; primary translational objective is ~90% IRF5 reduction in blood and ex vivo assays expect 50%–80% reductions in TLR7/8/9-driven biomarkers; first-in-human data anticipated in H2 2026 and patient POC (lupus) planned thereafter.
Gilead collaboration included a $40M upfront payment and up to $750M in milestones (including a $45M option payment); Sanofi partnership for KT-485 (IRAK4 degrader) can realize ~"nearly $1 billion" in milestones; Q4 2025 collaboration revenue was $2.9M attributable to Gilead.
Raised almost $1.0 billion in 2025; year-end cash balance $1.6 billion, which management states provides runway into 2029 and funds completion of both KT-621 Phase IIb trials and a large part of first Phase III.
Hired Neil Graham as Chief Development Officer (30+ years in drug development, including dupilumab leadership); continued internal pipeline advancement with plan to announce at least one new program annually and target a new development candidate in H2 2026.
Clear regulatory and development strategy: use AD Phase IIb to support other dermatologic indications and asthma Phase IIb to support other respiratory indications; intent to move to registrational/Phase III studies after Phase II completion and FDA discussion.
Good day, everyone. My name is Kahai Illani, and I will be your conference operator today. At this time, I would like to welcome you to the Kymera Therapeutics Fourth Quarter 2025 Results Call. [Operator Instructions] At this time, I would like to turn the call over to Justine Koenigsberg, Vice President, Investor Relations.
Good morning, and welcome to Kymera Therapeutics Quarterly Update Conference Call. Joining me today are Nello Mainolfi, our Founder, President and Chief Executive Officer; Jared Gollob, our Chief Medical Officer; and Bruce Jacobs, our Chief Financial Officer. Following our prepared remarks, we will open the call for questions from our publishing analysts. [Operator Instructions] Before we begin, I would like to remind you that today's discussion will include forward-looking statements subject to risks and uncertainties described in our most recent Form 10-K filed with the SEC. Please note that any forward-looking statements speak only as of today's date. And with that, I will now turn the call over to Nello.
Thank you, Justine, and thank you, everybody, for joining us this morning. As this is our year-end 2025 call, I wanted to spend a few minutes recapping what was an incredible year for Kymera. Those of you that know us well appreciate the fact that we're always forward-looking, highly focused on what's in front of us. And the bulk of the call would feature just that. But given how important our 2025 accomplishments were, I'm hoping that a quick reflection on the year will provide some context for the foundation we have set for 2026 and beyond. Before ...