Release Date: August 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Kymera Therapeutics Inc (KYMR, Financial) has made significant progress in its novel approach to drug development, emphasizing innovative molecular design and data-driven strategies.
- The company's STAT6, MDM2, and STAT3 programs have been featured at major medical congresses, highlighting their differentiated profiles.
- The IRAK4 program, partnered with Sanofi, has shown promising results in Phase 1 studies, leading to an expansion of Phase 2 trials.
- Kymera Therapeutics Inc (KYMR) has completed all IND-enabling studies for KT-621 with no safety findings, paving the way for Phase 1 trials.
- The company has a strong financial position with a cash balance of $702 million, providing a runway into the first half of 2027.
Negative Points
- The expansion of the IRAK4 Phase 2 trials will delay the Phase 2 results beyond the initially guided first half of 2025.
- R&D and G&A expenses have increased significantly, reflecting the extensive work and growth in the organization.
- The company faces competition in the STAT6 degrader space, particularly from Sanofi, which has licensed other STAT6 agents.
- The clinical data for KT-253 and KT-333 are still in early stages, with dose escalation ongoing and final data yet to be shared.
- The company's ambitious goal to develop oral drugs with biologics-like efficacy may face challenges in proving superior or equal efficacy in clinical settings.
Q & A Highlights
Kymera Therapeutics Inc (KYMR) Q2 2024 Earnings Call Highlights
Q: Just wondering if you could elaborate a little bit further on the type of data you and Sanofi were able to review as part of their decision to expand the Phase 2 program. Was it based on safety or efficacy? And when might we see data from the expanded Phase 2 trial?
A: There was an interim analysis of both safety and efficacy. Both Sanofi and Kymera had access to the blinded data, while the IDMC had access to both blinded and unblinded data. The review was supportive of further investment into the program. We expect an update on clinicaltrials.gov in the upcoming months, which will include expected completion dates. The Phase 2 results will be beyond the first half of 2025.
Q: On the R&D and G&A trends, how should we think about the trends there? And how should we think about the jump in collaboration revenues from Sanofi moving forward?
A: The growth in R&D and G&A expenses is as expected, with more back-end loaded spending this year. The jump in collaboration revenue from Sanofi was due to a catch-up in revenue related to the alliance. Future revenue levels will be more consistent with the deferred revenue balances on our balance sheet.
Q: Could you comment on the specific plans for the Phase 1 STAT6 program? Will it be a single indication or multiple indications?
A: The Phase 1 study will be in healthy volunteers, consisting of single-ascending dose and multiple-ascending dose phases. We will look at pharmacodynamic measures, including STAT6 degradation in blood and skin, and TH2 biomarkers in circulation. The goal is to confirm preclinical findings in humans.
Q: For the TYK2 program, how broad do you think the development program could be? What will you be looking for in the initial Phase 1 data to help make those decisions?
A: The TYK2 degrader aims to provide an oral molecule with a biologics-like profile. We expect it to be relevant in diseases like psoriasis, psoriatic arthritis, IBD, and lupus. The Phase 1 study will demonstrate full blockade of the pathway, and we plan to do a proof-of-concept in an indication that will demonstrate the differentiated profile.
Q: Can you discuss the confidence of TYK2 as a tractable target for IBD?
A: TYK2 small molecule inhibitors have had challenges in IBD due to off-target effects. Our TYK2 degrader can maximally block key inflammatory pathways while sparing IL-10 signaling, which is crucial for mucosal healing in IBD. We believe this will be a distinct advantage for our approach.
Q: Can you clarify the data presentation for KT-253 this year? Will it include the full clinical update or just the biomarker approach?
A: We plan to share our biomarker-based patient selection strategy for KT-253 later this year. The full clinical update will depend on when we complete dose escalation, which we expect by the end of the year.
Q: Can you talk about how we should interpret early biomarker data from the STAT6 healthy volunteer study next year?
A: The goal is to confirm preclinical findings in humans, including dose-dependent and robust degradation in blood and skin. We will look at biomarkers like TARC and IGE to confirm target engagement. This data will not be used for indication prioritization but to establish proof of mechanism.
Q: Can you discuss the challenges in creating the STAT6 degrader and how difficult it would be for another company to develop a similar molecule?
A: STAT6 has been a high-priority target for years. We have spent extensive effort on this program, and it is one of the best molecules we've made. Competing with Kymera in terms of timing and quality will be difficult for other companies.
Q: How might Sanofi's collaboration on a STAT6 degrader impact your collaboration for the IRAK4 degrader?
A: Kymera and Sanofi have different goals and strategies. Our collaboration on IRAK4 is independent of Sanofi's other efforts. We do not expect any impact on our IRAK4 collaboration from Sanofi's work on STAT6.
Q: Can you clarify the decision to expand the IRAK4 trials to include additional doses?
A: The expansion is to accelerate entry into a registrational Phase 3 study. The additional doses are necessary to establish the relationship between efficacy and safety. The doses will be within the 50 to 200 mg daily range.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
