• Revenue: $7.4 million, all from Sanofi collaboration.
• R&D Expenses: $71.8 million, including $6.8 million in non-cash stock-based compensation.
• Adjusted Cash R&D Spend: $65 million, a 23% increase from the previous quarter.
• G&A Expenses: $16.3 million, including $7 million in non-cash stock-based compensation.
• Adjusted Cash G&A Spend: $9.3 million, a 13% increase from the previous quarter.
• Cash Balance: $851 million, providing a runway into mid-2027.

• Warning! GuruFocus has detected 3 Warning Signs with KYMR.

Release Date: February 27, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Kymera Therapeutics Inc (NASDAQ:KYMR) successfully delivered on all key priorities for 2024, including the completion of IND-enabling studies for STAT6 and TYK2 programs.
• The company has a strong cash position with $851 million, providing a runway into mid-2027, enabling execution on multiple data readouts.
• Kymera Therapeutics Inc (NASDAQ:KYMR) is on track to report significant clinical data in 2025, including Phase I data for KT-621 and advancing KT-295 into the clinic.
• The company has a strategic collaboration with Sanofi, which is progressing with two ongoing Phase IIb studies in hidradenitis suppurativa (HS) and atopic dermatitis (AD).
• Kymera Therapeutics Inc (NASDAQ:KYMR) is committed to developing an industry-leading immunology pipeline featuring innovative oral small molecule therapies, aiming to provide biologics-like efficacy with the convenience of an oral pill.

Negative Points

• The company faces risks and uncertainties that may cause actual results to differ materially from projections, as highlighted in their forward-looking statements.
• Kymera Therapeutics Inc (NASDAQ:KYMR) has high R&D expenses, with a 23% sequential increase in adjusted cash R&D spend from the third quarter.
• The Phase 1b trial for KT-621 in atopic dermatitis is a small single-arm open-label trial, which may limit the ability to assess dose response and efficacy comprehensively.
• The company is transitioning to a video format for earnings calls, which may not be well-received by all stakeholders.
• There is uncertainty regarding the translation of preclinical data to clinical outcomes, particularly in novel targets like STAT6 and TYK2.

Q & A Highlights

Q: What supports your view that the 28-day dosing in the atopic dermatitis Phase Ib is enough time to show robust biomarker activity? How have you considered the inclusion/exclusion criteria for that Phase Ib? A: Jared Gollob, Chief Medical Officer, explained that prior dupilumab trials showed clear impacts on Th2 biomarkers and clinical endpoints like EASI and pruritus NRS within four weeks. The 28-day treatment should allow for a clear impact on Th2 biomarkers. The inclusion criteria ensure patients definitely have moderate to severe AD, minimizing placebo effects through rigorous site selection and monitoring.

Q: Why is the Phase 1b designed as a single-arm study without a placebo, especially given the placebo effects seen in other atopic dermatitis studies? A: Nello Mainolfi, CEO, stated that the study aims to demonstrate a robust biomarker profile comparable to dupilumab's four-week data. Biomarkers typically do not move substantially in placebo arms, and a placebo-controlled study would require a larger, longer trial. The focus is on moving quickly to Phase 2b.

Q: How do you plan to assess the bioavailability of KT-621 in tissues of interest, such as skin versus lung tissue? A: Nello Mainolfi, CEO, noted that preclinical data showed KT-621 is highly active at low oral doses and distributes evenly across tissues like blood, skin, spleen, and lungs. The expectation is that this profile will translate to humans, with blood and skin serving as surrogate tissues for measuring degradation.

Q: How will the Phase 1b study help shape the view of KT-621's profile potential, given its short duration and small size? A: Nello Mainolfi, CEO, emphasized that the Phase 1b study aims to demonstrate that STAT6 degradation has a dupilumab-like effect on biomarkers, which is crucial for convincing investigators and patients of the drug's potential. The study is designed to show that the drug is safe, well-tolerated, and effective in reducing biomarkers, setting the stage for Phase 2b studies.

Q: How do you plan to prioritize indications for KT-621 in the Phase 3 development program, given its broad potential? A: Nello Mainolfi, CEO, stated that the focus will be on a path to registration and breadth of opportunities. The initial Phase 3 campaigns will likely prioritize indications like asthma, AD, and potentially COPD, which are significant revenue drivers for similar drugs like dupilumab.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.