Erasca, Inc. (ERAS) R&D Update Call and Q4 2023 Earnings Call Transcript

Access earnings results, analyst expectations, report, slides, earnings call, and transcript.

Overview

The earnings call highlights strong financial performance and promising clinical trial results, with significant improvements in PFS and OS for Naporafenib plus Trametinib. Regulatory alignment and supportive interactions with FDA and Novartis further boost confidence. Despite some management vagueness, the overall sentiment is positive, driven by advancements in treatment efficacy and financial health. The positive developments in product efficacy and financial runway extension outweigh any concerns, suggesting a positive stock price movement in the short term.

Key Q&A

Q:- Anupam Rama: In SEACRAFT-2, is there a hierarchy between the dual primary endpoints of PFS and OS, and do you have regulatory sign-off?

A: - Jonathan Lim mentions that there is no hierarchy in the dual primary endpoints, and they have regulatory alignment from health authorities in the US and Europe.

Q:- Jeffrey Hung: How should we be thinking about the ORR rate between the 201 versus the 400.5 regimens?

A: - Jonathan Lim discusses that while ORR is important, PFS is the main driver, and both regimens show similar DCR rates, indicating potential clinical benefit.

Q:- Michael Riad: What is driving the decision to go for Chemo versus a single agent MEK inhibitor in the post IO setting?

A: - Jonathan Lim explains that regional preferences may influence the choice, with more patients and physicians likely choosing the MEK inhibitor.

Q:- Alec Stranahan: Any updates from recent FDA or Novartis interactions around the Napo pivotal program, and thoughts on powering needed in the randomized Phase 3?

A: - Jonathan Lim mentions positive feedback from regulators, and the Phase 3 trial is well-powered for both OS and PFS. Shannon Morris highlights the importance of OS data for regulatory and reimbursement purposes.

Q:- Jonathan Miller: How effective is rash prophylaxis in reducing discontinuations and maintaining dose intensity?

A: - Jonathan Lim notes the importance of maintaining dose intensity and mentions the potential impact of rash prophylaxis based on other targeted agents' development. Shannon Morris emphasizes the hope for an optimal risk-benefit profile with rash prophylaxis.

Q:- Michael Schmidt: How do the OS data compare to internal expectations, and is it possible to derive hazard ratios from cross-trial comparisons?

A: - Jonathan Lim mentions assumptions made during power calculations and the anticipation of statistical and clinical benefit based on control arm performance. He refrains from commenting on specific hazard ratios in cross-trial comparisons.

Q:- Chris Shibutani: What are the gating factors for the time frame of the 1b data from SEACRAFT-1, and how does the recent private placement give confidence in supporting programs?

A: - Jonathan Lim discusses enrollment progress and patient demographics for SEACRAFT-1. David Chacko highlights the private placement extending the runway to H2 of 2026.

Q:- Graig Suvannavejh: Were there patient characteristics driving the OS results in the Napo trial, and are there any read-throughs for RAS Q61X mutated solid tumors based on the data?

A: - Shannon Morris mentions no specific subset driving OS results, suggesting a reflection of the overall population. Jonathan Lim notes a direct read-through for RAS Q61X melanoma but mentions upcoming data-driven analysis for other tumor types.

Q:- Andres Maldonado: How should we balance the synergistic contribution to OS between Napo and Trametinib?

A: - Jonathan Lim acknowledges the difficulty in determining individual contributions but emphasizes that Stage 1 data will provide insight into the contributions of each component to the synergy observed.

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ERAS Transcript

Erasca, Inc. (ERAS) R&D Update Call and Q4 2023 Earnings Call Transcript

Positive3-29

ERAS Report

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