IDEAYA Biosciences Announces Q2 2024 Financial Results and Business Update

IDEAYA Biosciences, a precision medicine oncology company, provided a business update and announced financial results for the second quarter ending June 30, 2024. The company reported significant advancements in its clinical programs and solid financial standing to support ongoing and future projects.

During the second quarter, IDEAYA made notable progress in advancing four precision medicine oncology clinical programs and aims to introduce its fifth program targeting Werner Helicase by the end of the year. Preliminary clinical data for IDE397 monotherapy in MTAP-deletion urothelial and lung cancer demonstrated confirmed RECIST responses with a favorable adverse event (AE) profile. Combination therapy trials for IDE397 in MTAP-deletion solid tumors are ongoing, with the initiation of a Phase 1 trial evaluating IDE397 with Gilead's Trodelvy, and continued dose escalation in the AMG 193 clinical combination with Amgen.

IDEAYA shared interim clinical data from Phase 2 trials of darovasertib in neoadjuvant uveal melanoma (UM) at the ASCO 2024 meeting. The company has scheduled a Type C meeting with the FDA to discuss a potential registrational trial for darovasertib in the neoadjuvant UM setting in the third quarter of 2024.

Key developments in clinical programs include:
1. Darovasertib in Neoadjuvant Uveal Melanoma (UM):
- Interim data from the Phase 2 trial were presented at ASCO 2024.
- Over 50 patients have been enrolled globally, with a clinical update expected in the second half of 2024.
- A Type C meeting with the FDA is scheduled for Q3 2024 to discuss a registrational trial for darovasertib in the neoadjuvant UM setting.

2. IDE397 in MTAP-Deletion Solid Tumors:
- Selected 30 mg as the move-forward Phase 2 expansion dose in urothelial cancer and squamous non-small cell lung cancer (NSCLC).
- Reported positive interim data from 18 evaluable patients.
- First patient dosed in the Phase 1 trial evaluating IDE397 in combination with Gilead's Trodelvy in MTAP-deletion urothelial cancer.
- Ongoing dose escalation in the IDE397 / AMG 193 clinical combination, with financial support from Amgen for NSCLC expansion.

3. IDE161 Program in Tumors with Homologous Recombination Deficiency (HRD):
- IDE161 is a potential first-in-class inhibitor of poly(ADP-ribose) glycohydrolase (PARG).
- Phase 1/2 monotherapy expansion in HRD solid tumors is on track for the second half of 2024.
- Plans to evaluate IDE161 in combination with Merck's KEYTRUDA® in endometrial cancer, with the first patient-in targeted for the second half of 2024.

IDEAYA's corporate development highlights include raising approximately $302.4 million through a public offering in July 2024, enabling the company to fund its operations into at least 2028. The company also appointed Daniel A. Simon as Chief Business Officer.

Financial results:
- As of June 30, 2024, IDEAYA had $952.7 million in cash, cash equivalents, and marketable securities.
- The company's R&D expenses for the second quarter totaled $54.5 million, an increase from $42.8 million in the first quarter, driven by higher stock-based compensation, clinical trial expenses, and consulting fees.
- G&A expenses increased to $10.4 million from $8.2 million in the previous quarter.
- The net loss for the second quarter was $52.8 million, compared to $39.6 million in the first quarter.

IDEAYA is committed to advancing its precision medicine oncology pipeline, with multiple development candidates expected by the end of the year. The company is focused on delivering innovative targeted therapeutics for patient populations selected using molecular diagnostics.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!