IDEAYA Biosciences Announces Q1 2024 Financial Results and Business Update

IDEAYA Biosciences, Inc., a precision medicine oncology firm, has provided an update on its business and financial results for the first quarter ending March 31, 2024. The company highlighted significant advancements in its clinical programs, focusing on targeted therapeutics for selected patient populations based on molecular diagnostics.

Key developments include the acceptance of interim data from a Phase 2 trial of darovasertib in neoadjuvant uveal melanoma (UM) for an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Additionally, IDEAYA plans to provide updates from its company-sponsored Phase 2 trial for neoadjuvant UM and seek FDA regulatory guidance in the latter half of 2024.

The company has selected a Phase 2 dose for IDE397 in MTAP-deletion squamous non-small cell lung cancer (NSCLC), following positive preliminary clinical efficacy results. Multiple partial responses have also been observed in MTAP-deletion bladder cancer with IDE397 monotherapy. Enrollment is ongoing for the Phase 1 dose escalation of IDE397 in combination with AMG 193, with a joint publication strategy planned for 2024. IDEAYA is also targeting the initiation of a Phase 1 trial of IDE397 in combination with Gilead’s Trodelvy® for MTAP-deletion bladder cancer by mid-2024.

Another focus is IDE161, a poly(ADP-ribose) glycohydrolase (PARG) inhibitor targeting homologous recombination deficiency (HRD) solid tumors. IDE161 has received two FDA Fast Track designations and is currently in a Phase 1/2 trial. The company aims to select a Phase 2 monotherapy expansion dose in HRD solid tumors by the second half of 2024. Moreover, IDEAYA plans to start a Phase 1 trial of IDE161 with Merck’s KEYTRUDA® in endometrial cancer in the latter half of 2024.

The Werner Helicase inhibitor program, in collaboration with GSK, is on track for an IND filing later in 2024. GLP toxicology studies have been completed, paving the way for potential clinical trials. IDEAYA is also targeting the nomination of multiple development candidates, including for MTAP-deletion solid tumors, by the second half of 2024.

Financially, IDEAYA reported cash, cash equivalents, and marketable securities totaling $941.4 million as of March 31, 2024, compared to $632.6 million at the end of 2023. The increase was primarily due to net proceeds from the sale of shares through ATM offerings. R&D expenses rose to $42.8 million for the first quarter of 2024, up from $38.8 million in the previous quarter, mainly due to increased clinical trial and personnel-related costs. G&A expenses also increased to $8.2 million from $7.1 million in the same period. The net loss for the first quarter of 2024 was $39.6 million, compared to $34.0 million in the previous quarter.

IDEAYA continues to push forward with its clinical programs and partnerships. The company is dedicated to advancing its pipeline of targeted therapeutics, leveraging collaborations with major pharmaceutical companies like Gilead, Amgen, Merck, and GSK. With a strong balance sheet and a focus on precision medicine, IDEAYA aims to bring innovative treatments to patients with specific genetic profiles.

As the company looks to the future, it remains committed to its strategic vision of becoming a leader in precision medicine oncology. The upcoming milestones in 2024, including clinical trials and regulatory submissions, are expected to further solidify IDEAYA’s position in the market.