IDEAYA Biosciences Announces Corporate and Portfolio Update for J.P. Morgan 40th Annual Healthcare Conference

Rhea-AI Summary

IDEAYA Biosciences, Inc. (NASDAQ: IDYA) announced key corporate updates ahead of the J.P. Morgan 40th Annual Healthcare Conference on January 11, 2022. The company reported a robust balance sheet with approximately $386 million in cash and equivalents, expected to fund operations into 2025. They completed enrollment in the Phase 1 trial for IDE397, targeting FDA amendment in Q1 2022. Additionally, IDEAYA aims to submit IND for a PARG inhibitor by Q4 2022 and expand indications for darovasertib. GSK milestone payments of $70 million could be triggered through upcoming developments.

Positive

• Strong balance sheet with ~$386 million cash to fund operations into 2025.
• Completed enrollment in Phase 1 trial for IDE397, indicating progress in clinical development.
• Targets FDA protocol amendment for IDE397 in Q1 2022, enabling further trials.
• Potential GSK opt-in decision could bring in $50 million.
• Plans to initiate IND submission for PARG inhibitor by Q4 2022.
• Potential GSK milestone payments totaling $20 million for Pol Theta Helicase program.

Negative

• Dependence on upcoming clinical trial results for continued funding and success.
• Potential risks associated with FDA approval processes for clinical trials.

SOUTH SAN FRANCISCO, Calif., Jan. 10, 2022 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced corporate and portfolio updates in connection with its participation in the J.P. Morgan Annual Healthcare Conference.

Yujiro Hata, President and Chief Executive Officer of IDEAYA, will present at the J.P. Morgan 40^th Annual Healthcare Conference on Tuesday, January 11, 2022 at 9:45 am ET.  The presentation will be followed by an analyst-hosted Q&A session with Anupam Rama, Managing Director, US SMID Biotechnology Equity Research, J.P. Morgan. 

Key corporate and portfolio updates, which the company is planning to discuss in its J.P. Morgan presentation, include:

• Strong balance sheet of ~$386 million cash, cash equivalents and marketable securities as of September 30, 2021, is anticipated to fund planned operations into 2025
• Completed enrollment into dose escalation Cohort 5 of the Phase 1 clinical trial evaluating IDE397, a potential best-in-class MAT2A inhibitor, in patients with MTAP-deletion tumors; Cohort 5 is an estimated clinically active dose based on the preclinical PDx data
• Targeting IDE397 protocol amendment to FDA in Q1 2022 to enable monotherapy cohort expansions, and combination initiation in first half of 2022
• Targeting delivery of GSK option data package for IDE397 in first half of 2022 to trigger a review period for potential $50 million opt-in decision
• Demonstrated preclinical in vivo efficacy of IDE397 plus standard-of-care combination agents, including with paclitaxel in head and neck cancer
• Targeting PARG inhibitor IND submission in fourth quarter of 2022, subject to satisfactory completion of ongoing preclinical and IND-enabling studies
• Targeting initiation of IND-enabling studies for Pol Theta Helicase program in first half of 2022; potential $20 million aggregate GSK milestone payments for preclinical to early Phase 1
• Observed Werner Helicase inhibitor in vivo efficacy with approximately 100% tumor growth inhibition; targeting Werner Helicase development candidate nomination in 2023
• Enrolling into Phase 2 clinical trial evaluating darovasertib and crizotinib clinical combination in Metastatic Uveal Melanoma; targeting update of clinical data and regulatory guidance on potential registrational clinical trial in first half 2022
• Evaluating potential indication expansion for darovasertib into additional MET-driven tumors, such as hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC)

A live audio webcast of IDEAYA's J.P. Morgan presentation will be available, as permitted by conference host, at the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at https://ir.ideayabio.com/events.  A replay of available webcasts will be accessible for 30 days following the live event.

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

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About IDEAYA Biosciences

IDEAYA is a synthetic lethality-focused 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 early research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets. 

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Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to (i) participation in and/or presentation at certain investor relations events, (ii) the extent to which IDEAYA's existing cash, cash equivalents, and marketable securities will fund its planned operations, (iii) the timing of submission of a clinical protocol amendment for the IDE397 Phase 1 clinical trial, (iv) the timing of the delivery of the GSK option data package, (v)  the timing of IND submission for the PARG inhibitor, (vi) the timing of IND-enabling studies for Pol Theta Helicase program and GSK milestone payments, (vii) the timing of development candidate nomination for Werner Helicase, and (viii) the timing of a clinical data and regulatory guidance update for the darovasertib and crizotinib combination. 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 Quarterly Report on Form 10-Q filed on November 15, 2021 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

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SOURCE IDEAYA Biosciences, Inc.

FAQ

What updates did IDEAYA Biosciences announce on January 10, 2022?

IDEAYA announced a strong balance sheet, completion of enrollment in the IDE397 Phase 1 trial, and plans to submit a clinical protocol amendment and IND applications in 2022.

What is the significance of the IDE397 trial for IDEAYA?

The IDE397 trial is crucial as it positions IDEAYA to seek FDA protocol amendments and expand its clinical development, potentially impacting its revenue and market position.

How much cash does IDEAYA have as of September 30, 2021?

IDEAYA reported approximately $386 million in cash, cash equivalents, and marketable securities.

What financial opportunities are tied to GSK for IDEAYA?

IDEAYA could receive a $50 million opt-in decision from GSK and an additional $20 million in milestone payments related to the Pol Theta Helicase program.

When will IDEAYA present at the J.P. Morgan Healthcare Conference?

IDEAYA will present on January 11, 2022, at 9:45 am ET.