Kymera Therapeutics (KYMR) Q2 FY26 earnings call: guidance and Q&A

Asked about baseline patient characteristics in BROADEN-2 compared to prior studies and specific efficacy/safety expectations for KT-621 relative to Dupixent.

Nello stated that the goal was to ensure patients with the right severity were enrolled, aiming for characteristics similar to recent studies, though not necessarily replicating the higher severity of very early Dupixent trials. For success, the company aims to deliver an effective, safe, well-tolerated oral option, expecting efficacy data in the "ballpark" of Dupixent's week 16 results, acknowledging study differences.

“our, let's say, data expectation is we will continue to be in this study to be in that ballpark of what dupilumab has shown at week 16 in the previous AD studies, understanding that, obviously, different studies, different populations.”

asked by Thomas Smith · answered by Nello Mainolfi

Asked what Kymera hopes to learn from the Q4 2026 healthy volunteer data for KT-579, especially since lupus has already been selected for Phase 1b.

Nello explained that the Phase I study aims to demonstrate robust and safe IRF5 degradation (at least 90%) and then show modulation of three key pathways (B-cell autoantibodies, inflammatory cytokines, type 1 interferon) using ex vivo stimulation assays. This data will provide confidence to advance into lupus and potentially other indications.

“we expect that while this is not a patient study, the fact that even in healthy volunteer, we can interrogate the relevance of these 3 pathways by blocking IRF5 signaling, I think, should give us the confidence to move into, as you say, lupus, but actually we're planning and discussing internally what other indications we could start as well in the relatively immediate future.”

asked by Tazeen Ahmad · answered by Nello Mainolfi

Asked about assumptions for placebo response and effect size when powering the BROADEN-2 study, given high placebo rates in some AD studies, and if enrollment dynamics changed confidence.

Nello stated they powered the study within a range of expectations for STAT6 biology and accounted for increased placebo rates seen in recent studies. He noted that while some studies had "crazy high" placebo rates (70s), their powering considered more typical increases. Enrollment speed did not change their power assumptions.

“We obviously know that the placebo rates have increased and we've accounted for that. Obviously, there has been a couple of cases where at least one where we had some crazy high placebo rate in the 70s. Obviously, no study can plan around such a high placebo rate.”

asked by Xiaochuan Dai · answered by Nello Mainolfi

Inquired about enrollment progress in the asthma trial, potential for similar acceleration as AD, and factors contributing to timeline differences.

Nello explained that both studies benefit from excitement around the mechanism and the need for an oral option. However, the asthma study has a smaller denominator due to specific FeNO and eosinophilia entry criteria, leading to a higher screen failure rate. While enrollment is good, it's unlikely to match the speed of the AD study. Timelines will only be updated upon enrollment completion.

“For the asthma study, if you recall, we had some specific criteria with regards to FeNO and eosinophilia at baseline, which is looking at a subset of asthma patients... So naturally, the denominator is smaller in this case. And because we have this, again, very specific entry criteria, generally, we would see a higher screen failure rate.”

asked by Unknown Analyst · answered by Nello Mainolfi

Asked about Kymera's latest thoughts on the competitive landscape, including other STAT6 programs (Pfizer, Nurix/Sanofi) and novel mechanisms like bispecifics/trispecifics.

Nello stated Kymera's focus is on execution to maintain its timeline advantage. He noted Pfizer's STAT6 program seems to have a long timeline (completing study in early '28) and expressed skepticism about small molecule inhibitors competing with degraders. He views KT-621 as a potential first-in-line drug for AD, with bispecifics/trispecifics potentially serving later lines or specific patient subsets. Kymera is interested in novel mechanisms and potential combinations.

“I think they're reporting to complete the study in early '28, which seems like a very long time.”

asked by Faisal Khurshid · answered by Nello Mainolfi

Asked how Kymera is positioning itself to extend KT-621's benefit to pediatric AD patients and if they are doing anything to accelerate development beyond adults and adolescents.

Nello confirmed a heavy focus on accelerating pediatric development, noting that adolescents (12 and up) are already included in their study. He stated that going to younger ages requires regulatory discussions and that the Phase 2b data will be crucial for initiating those discussions. Kymera will be ready to proceed as soon as allowed.

“I mean the one thing that we've done, as you know, is incorporating adolescents in our study, right? We have 12 and up, which actually are pediatric patients.”

asked by Bradley Canino · answered by Nello Mainolfi

Asked if the accelerated timelines for KT-621 impact the cash runway guidance into 2029 or require changes to spend trajectory.

Bruce Jacobs confirmed the cash runway into 2029 remains intact, stating that the acceleration is not enough to pull the runway in. He mentioned there was some cushion and that the runway supports the completion of current Phase 2b trials, KT-579 PoC, and the beginning stages of both AD and asthma Phase III studies.

“Even with the acceleration of timing, it's not enough to pull the runway in closer. So we're still into 2029 with that. So you can assume there has been a bit of cushion there as well.”

asked by Judah Frommer · answered by Bruce Jacobs

Asked to what extent the launch of oral IL-23 (Icotyde) in psoriasis could serve as an analog for KT-621 commercialization in AD, and what lessons could be learned.

Nello noted similarities in Icotyde being a novel oral drug for a validated mechanism with good efficacy/safety. The key difference is the market: psoriasis is mature, while AD is immature with low penetration and a significant unmet need for oral options. He believes KT-621 could see superior success in AD due to this unmet need, assuming a good profile. Terence Rooney, who was involved with Icotyde, acknowledged the challenges of lupus drug development and emphasized patient/site selection and trial design.

“I think in the first quarter, there are more than 100,000 patients on the drug, if I'm not wrong.”

asked by David Hoang · answered by Nello Mainolfi