IDEAYA Biosciences Announces Participation at the 42nd Annual J.P. Morgan Healthcare Conference and 2024 Corporate Guidance
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Insights
The financial health of IDEAYA Biosciences, Inc. is underscored by a robust balance sheet, reporting $511.1 million in cash, cash equivalents and marketable securities as of September 30, 2023. The estimated net proceeds of $134.7 million from subsequent financing and a $10 million receivable from GSK suggest a strong cash runway, with funding anticipated to extend operations into 2028. This financial stability is critical for investors as it reduces the immediate risk of dilution and provides the company with a buffer to advance its clinical programs without the pressure of short-term financing.
Furthermore, the strategic collaboration with GSK, indicated by the receivable, may offer additional validation of IDEAYA's scientific pursuits and could be a positive signal for the stock's potential. From an investment perspective, the extended cash runway combined with a diversified clinical pipeline, including the darovasertib and crizotinib combination, may position IDEAYA as an attractive opportunity in the precision medicine oncology sector.
IDEAYA Biosciences' focus on targeted therapeutics in oncology is highlighted by the Phase 2/3 clinical trial of darovasertib and crizotinib in metastatic uveal melanoma (MUM), a cancer with limited treatment options. Achieving international site activation and double-digit patient enrollment are significant milestones that suggest the trial is progressing as planned. The potential for this combination therapy to become a first-line treatment for HLA-A2(-) MUM patients could have a substantial impact on the standard of care in this indication.
The preliminary clinical efficacy observed in MTAP deletion solid tumors, including a complete response in bladder cancer and 33% tumor shrinkage in non-small cell lung cancer (NSCLC), is particularly noteworthy. These results, though early, could indicate a significant therapeutic benefit and position IDEAYA to capitalize on an area of high unmet medical need. The ongoing enrollment of IDE397 and AMG 193 in Phase 1 studies and the anticipated Phase 1 IDE397 and Trodelvy® combination study further underscore the company's commitment to exploring novel therapeutic approaches.
IDEAYA Biosciences' strategic focus on a multi-pronged strategy in MTAP-deletion and leveraging artificial intelligence/machine learning (AI/ML) for drug discovery could set the company apart in a competitive oncology market. The company's intention to nominate multiple next-generation development candidates in 2024 reflects a proactive approach to pipeline expansion and innovation. The advancements in their AI/ML platform could enhance drug discovery efficiency and lead to a more robust pipeline, potentially increasing the company's market value and investor confidence.
Additionally, the company's collaboration with GSK, particularly the Phase 1 dose escalation for GSK101 and the upcoming IND submission for a Werner Helicase Inhibitor, could provide strategic advantages in the form of milestone payments and shared development risks. The potential $7.0 million milestone upon IND clearance for the Werner Helicase Inhibitor suggests a forthcoming influx of non-dilutive capital that could support further research and development activities.
42nd Annual J.P. Morgan Healthcare Conference
Tuesday, January 9th, 2024 at 8:15 AM PT (11:15 AM ET)
- Presentation by Yujiro S. Hata, Chief Executive Officer followed by analyst-hosted Q&A with Anupam Rama, Managing Director, US SMID Biotechnology Equity Research, J.P. Morgan
IDEAYA's 2024 corporate guidance and program updates include:
- Balance sheet of
$511.1 million $134.7 million $10 million
- International site activation and double-digit patient enrollment achieved in potential registration-enabling Phase 2/3 clinical trial of darovasertib and crizotinib combination in first-line HLA-A2(-) metastatic uveal melanoma (MUM)
- Clinical program update(s) in 2024 for potential registration-enabling Phase 2/3 clinical trial of darovasertib and crizotinib combination in first-line HLA-A2(-) MUM
- Targeting clinical efficacy update from Phase 2 company sponsored neoadjuvant uveal melanoma (UM) study in mid-year 2024 and regulatory guidance update in 2024
- Targeting ongoing enrollment of IDE397 and AMG 193 Phase 1 combination study in MTAP-deletion solid tumors and development of joint publication strategy in 2024
- Anticipate First-Patient-In of Phase 1 IDE397 and Trodelvy® clinical combination study in MTAP-deletion bladder cancer in mid-year 2024
- Preliminary IDE397 clinical efficacy observed in MTAP deletion solid tumors, including RECIST 1.1 complete response in bladder cancer patient,
33% tumor shrinkage in NSCLC patient by CT/PET, and multiple ctDNA molecular responses in NSCLC and bladder cancer
- Targeting IDE161 clinical program update(s) and enabling of clinical combination(s) in 2024
- Preliminary IDE161 clinical efficacy observed in HRD solid tumors, including RECIST 1.1 partial responses in priority solid tumor types and >
50% PSA reduction in a prostate cancer patient
- Targeting ongoing enrollment of IDE161 Phase 1 expansion in HRD solid tumor priority types, including endometrial, colorectal, prostate, and ER+ HER2- breast cancers
- Advancing Phase 1 dose escalation for GSK101 (IDE705) Pol Theta Helicase inhibitor, and targeting IND submission in 2024 for Werner Helicase Inhibitor Development Candidate (
$7.0 million
- Targeting multiple wholly-owned next generation development candidate nominations in 2024, including in MTAP-deletion, further advancing IDEAYA's multi-pronged strategy in MTAP-deletion and AI/ML and structurally-enabled drug discovery platform
IDEAYA's updated corporate presentation reflecting its 2024 corporate guidance is available on its website, at the Investor Relations page: https://ir.ideayabio.com/.
A live audio webcast of the event, as permitted by conference host, will be available 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.
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 early research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets.
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 and (ii) 2024 corporate guidance. 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 recent Quarterly Report on Form 10-Q filed on November 7, 2023 and any current and periodic reports filed with the
Investor and Media Contact
IDEAYA Biosciences
Andres Ruiz Briseno
Senior Vice President, Head of Finance and Investor Relations
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.
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