Over 230 patients enrolled in potential registration-enabling trial in 1L HLA-A2-negative MUM, and median PFS readout targeted by year-end 2025 95 patients enrolled in neoadjuvant UM trial and targeting clinical data and regulatory update(s) in H1 2025, including vision data in plaque brachytherapy patients Targeting median OS readout in ~40 1L MUM patients in 2025 Targeting expansion of study in Q1 2025 of IDE397 in combination with Trodelvy® (sacituzumab govitecan-hziy) in MTAP-deletion UC and clinical data update in 2025; expanded clinical study collaboration into NSCLC Targeting to enable wholly owned IDE397 and IDE892 (IDEAYA PRMT5) clinical combination in H2 2025; IDEAYA and Amgen mutually agree to wind down the IDE397 and AMG 193 clinical combination study Clinical expansion doses selected for DLL3 TOP1i ADC IDE849 by collaboration partner Hengrui, and targeting clinical data update and combo initiation with IDE161 in 2025 Ph1 initiated for Werner Helicase IDE275 (GSK959) and received $7 million milestone from GSK, and targeting medical conference update in H1 2025 Targeting IDE161 expansion with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, and combo(s) with TOP1i ADCs in solid tumors in 2025 Targeting 2025 INDs: IDE892 (PRMT5); IDE034 (B7H3/PTK7 ADC); IDE251 (KAT6/7) ~$1.1 billion of cash, cash equivalents and marketable securities as of December 31, 2024, anticipated to fund operations into at least 2028

SOUTH SAN FRANCISCO, Calif., Feb. 13, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced financial results for the quarter and full year ended December 31, 2024, and provided a business update.(PRNewsfoto/IDEAYA Biosciences, Inc.)

"We are excited to be targeting multiple clinical data readouts and program updates across our clinical pipeline in 2025, including the darovasertib neoadjuvant UM data update in the first half and median PFS readout in HLA-A2 negative 1L MUM by year-end, update on the Werner Helicase inhibitor program IDE275 at a major medical conference in the first half, clinical combination results from the IDE397 and Trodelvy combination in MTAP-deletion UC where the Gilead collaboration has expanded to evaluate both UC and NSCLC, among others.  Next, we are excited to target a clinical data update for potential first-in-class DLL3 TOP1 ADC IDE849 in SCLC in 2025, including potentially at a medical conference, and we believe the clinical profile observed supports a potential monotherapy regulatory path in SCLC," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

Story Continues

"We had multiple positive clinical updates across our pipeline throughout the past year that were presented at major medical conferences, including compelling results such as tumor shrinkage and eye preservation for neoadjuvant darovasertib which was presented as an oral presentation at ASCO 2024, and evidence for monotherapy activity with IDE397 which delivered a high disease control rate and multiple confirmed RECIST 1.1 responses in MTAP-deletion lung and urothelial cancer, which was presented as a late breaker oral presentation at ENA 2024.  Next, we believe we have generated important proof-of-concept preclinically and preliminary clinical data for the MAT2A and PRMT5 combination in the MTAP-deletion setting and are excited to advance IDEAYA's wholly-owned IDE397 and IDE892 combination that we are targeting to have in the clinic in the second half of 2025," commented Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences. "Additionally, in the last several quarters we made significant progress in enhancing our potential first-in-class clinical pipeline with the in-licensing of the Phase 1 DLL3 TOP1i ADC IDE849 and FDA clearance of the Phase 1 trial for the Werner Helicase inhibitor IDE275. We are also advancing three programs into IND-enabling studies: our PRMT5 inhibitor IDE892, the B7H3/PTK7 ADC IDE034 and a KAT6/7 inhibitor IDE251," said Michael White, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.

Recent Key Developments and Upcoming Milestones

Research and Clinical Development

Darovasertib, a potential first-in-class Phase 2/3 PKC inhibitor for the treatment of metastatic uveal melanoma (MUM) and neoadjuvant uveal melanoma (UM). IDE397, a potential first-in-class Phase 2 MAT2A Inhibitor for the treatment of MTAP-Deletion Solid Tumors. IDE849 (SHR-4849), a potential first-in-class Phase 1 DLL3 TOP1i antibody drug conjugate (ADC) targeting small cell lung cancer (SCLC) and neuroendocrine tumors (NETs). IDE275 (GSK959), a potential first-in-class and best-in-class Phase 1 Werner Helicase inhibitor for the treatment of high microsatellite instability (MSI-High) tumors. IDE161, a potential first-in-class Phase 1 PARG inhibitor for the treatment of solid tumors. IDE705 (GSK101), a potential first-in-class Phase 1 Pol Theta Helicase Inhibitor in combination with PARP inhibitor for the treatment of HRD solid tumors. Announced three development candidates for the treatment of solid tumors:

Corporate Development

Appointed Joshua Bleharski, Ph.D., as Chief Financial Officer. Dr. Bleharski to join IDEAYA from J.P. Morgan, serving most recently as Managing Director and Global Co-Head of Biopharma in the Healthcare Investment Banking group.  Josh spent nearly 17 years at J.P. Morgan advising clients in the biopharma sector on capital markets transactions, corporate strategy and other investment banking services representing more than $65 billion of value for biotechnology companies worldwide. Appointed Stu Dorman as Chief Commercial Officer. Mr. Dorman brings over 20 years of global commercialization experience in oncology with prominent biopharmaceutical companies such as Gilead Sciences and Bristol Myers Squibb, where he led multiple commercial launches for products including Trodelvy and Opdivo.

Financial Results

As of December 31, 2024, IDEAYA had cash, cash equivalents and marketable securities of approximately $1.1 billion, compared to $632.6 million as of December 31, 2023. The increase was primarily driven from $379.9 million in net proceeds from the sale of common stock shares through at-the-market financings during the year, $283.8 million from an underwritten public offering of common stock and pre-funded warrants to purchase common stock completed in July 2024, partially offset by net cash used in operations. IDEAYA believes that these funds will be sufficient to fund its planned operations into at least 2028.

Subsequent to the reporting period for the year ended December 31, 2024, the Company generated net proceeds of approximately $25.1 million from the sale of shares of its common stock through at-the-market (ATM) offerings in January 2025.

Collaboration revenue for the three months ended December 31, 2024 totaled $7.0 million compared to $3.9 million for the three months ended December 31, 2023. Collaboration revenue was recognized for a $7.0 million milestone payment from GSK that was earned for the IND clearance of IDE275 (GSK959) in October 2024.

Research and development (R&D) expenses for the three months ended December 31, 2024, totaled $140.2 million compared to $38.8 million for the three months ended December 31, 2023. The increase was primarily due to a $75.0 million upfront payment under the license agreement for IDE849 with Hengrui Pharma, higher clinical trial expenses to support the portfolio growth and personnel-related expenses.

General and administrative (G&A) expenses for the three months ended December 31, 2024 totaled $11.0 million compared to $7.1 million for the three months ended December 31, 2023. The increase was primarily due to higher personnel-related expenses, higher consulting and legal fees.

The net loss for the three months ended December 31, 2024, was $130.3 million compared to the net loss of $34.0 million for the three months ended December 31, 2023. Total stock compensation expense for the three months ended December 31, 2024, was $9.5 million compared to $4.8 million for the same period in 2023.

The net loss for the year ended December 31, 2024 was $274.5 million compared to $113.0 million for the same period in 2023. Total stock compensation expense for the year ended December 31, 2024, was $34.7 million compared to $18.5 million for the same period in 2023.

About IDEAYA Biosciences

IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets.

IDEAYA's updated corporate presentation is available on its website, at its Investor Relations page: https://ir.ideayabio.com/.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to (i) the timing and content of clinical program updates, regulatory updates and clinical trial data readouts; (ii) the potential therapeutic benefits of IDEAYA therapeutics; (iii) the translation of preliminary clinical trial results into future clinical trial results and/or regulatory approval; (iv) timing of development and regulatory milestones; (v) the timing and potential of registration-enabling trial and readouts for darovasertib in 1L HLA-A2 negative MUM; (vi) the timing of the initiation of Phase 3 trial for darovasertib; (vii) the timing and potential for accelerated FDA approval of darovasertib in MUM; (viii) the timing of expansion in IDE397 and Trodelvy combination trial in MTAP-deletion UC and indication in NSCLC; (ix) the timing of combination trial of IDE397 and IDE892 in patients with MTAP-deletion NSCLC; (x) the potential of a Phase 2 expansion monotherapy dose for IDE161; (xi) the timing of initiating IDE161 and DLL3 TOP1i ADC combination trial; (xii) the timing of IDE161 expansion with KEYTRUDA and combinations with TOP1i ADCs in solid tumors; (xiii) timing of INDs for IDE892, IDE034, IDE251, and IDE849; (xiv) timing of data presentation for IDE275 at medical conference; and (xv) the extent to which IDEAYA's existing cash, cash equivalents, and marketable securities will fund its planned operations. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's Annual Report on Form 10-K dated February 20, 2024 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

Investor and Media Contact

IDEAYA Biosciences
Andres Ruiz Briseno
SVP, Head of Finance and Investor Relations 
[email protected]

IDEAYA Biosciences, Inc. Condensed Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts)  Three Months Ended   Year Ended  December 31,   December 31,  2024   2023   2024   2023  (Unaudited)   (Unaudited)  Collaboration revenue  $ 7,000   $ 3,923   $ 7,000   $ 23,385  Operating expenses:  Research and development   140,183    38,770    294,673    129,508  General and administrative   10,955    7,068    39,302    28,306  Total operating expenses   151,138    45,838    333,975    157,814  Loss from operations   (144,138)    (41,915)    (326,975)    (134,429)  Interest income and other income, net   13,826    7,960    52,498    21,468  Net loss   (130,312)    (33,955)    (274,477)    (112,961)  Unrealized gains (losses) on 
 marketable securities   (3,024)    1,312    250    3,433  Comprehensive loss  $ (133,336)   $ (32,643)   $ (274,227)   $ (109,528)  Net loss per share 
 attributable to common
 stockholders, basic and diluted  $ (1.49)   $ (0.52)   $ (3.36)   $ (1.96)  Weighted-average number of shares
 outstanding, basic and diluted   87,340,758    65,246,361    81,678,069    57,519,929

IDEAYA Biosciences, Inc. Condensed Balance Sheet Data (in thousands)  December 31,   December 31,  2024   2023  (Unaudited)  Cash and cash equivalents and short-term and 
 long-term marketable securities  $ 1,082,151   $ 632,606  Total assets   1,124,091    649,316  Total liabilities   64,944    28,226  Total liabilities and stockholders' equity   1,124,091    649,316 Cision

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