SOUTH SAN FRANCISCO, Calif. - IDEAYA Biosciences, Inc. (NASDAQ: NASDAQ:IDYA), a precision medicine oncology company, has outlined its corporate guidance for 2024, including financial projections and updates on its clinical programs.
The company reported a strong financial position, with a balance sheet showing $511.1 million in cash, cash equivalents, and marketable securities as of September 30, 2023. Additionally, estimated net proceeds of $134.7 million from recent financing activities and a $10 million receivable from GSK are expected to fund operations into 2028.
In its clinical program, IDEAYA has achieved international site activation and significant patient enrollment in a potential registration-enabling Phase 2/3 clinical trial of darovasertib and crizotinib combination for the treatment of first-line HLA-A2(-) metastatic uveal melanoma (MUM). The company anticipates providing a clinical efficacy update from its Phase 2 neoadjuvant uveal melanoma study in mid-2024, along with regulatory guidance updates.
Other 2024 targets include ongoing enrollment and a joint publication strategy for the IDE397 and AMG 193 Phase 1 combination study in MTAP-deletion solid tumors. IDEAYA also expects the first patient in a Phase 1 IDE397 and Trodelvy® clinical combination study in MTAP-deletion bladder cancer by mid-year. Preliminary clinical efficacy for IDE397 has been observed, including a complete response in a bladder cancer patient and tumor shrinkage in a non-small cell lung cancer (NSCLC) patient.
Updates on IDE161, a treatment for HRD solid tumors, are also planned for 2024. Preliminary efficacy results have shown partial responses in certain solid tumor types and a significant PSA reduction in a prostate cancer patient. The company is aiming to continue enrollment for the IDE161 Phase 1 expansion in priority HRD solid tumor types.
Furthermore, IDEAYA is advancing its Phase 1 dose escalation for GSK101 and targeting an IND submission for a Werner Helicase Inhibitor Development Candidate, with a potential $7.0 million milestone upon IND clearance under its collaboration with GSK.
The company is also planning to nominate multiple wholly-owned next-generation development candidates in 2024, building on its strategy in MTAP-deletion and its AI/ML and structurally-enabled drug discovery platform.
The updated corporate presentation reflecting IDEAYA's 2024 guidance is available on the Investor Relations page of the company's website. This article is based on a press release statement from IDEAYA Biosciences.
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