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IDEAYA Biosciences, Inc. (NASDAQ: IDYA) is an innovative biotechnology firm concentrated on oncology. Established in 2015 and headquartered in South San Francisco and La Jolla, California, the company is dedicated to the discovery and development of precision medicine therapies for genetically defined patient groups. Their focus areas include synthetic lethality and immuno-oncology, targeting DNA damage repair mechanisms and the tumor microenvironment, respectively.
IDEAYA's pioneering approach leverages molecular diagnostics to identify and develop targeted therapeutics. The company's leading product candidate, IDE196, is a potent inhibitor of protein kinase C (PKC), aimed at treating cancers with GNAQ or GNA11 mutations. In addition, IDEAYA is advancing several clinical programs, such as the darovasertib program, which is currently in Phase 2 trials for uveal melanoma (UM) and has shown promising results in tumor shrinkage and eye preservation.
In synthetic lethality, IDEAYA's IDE397 targets methionine adenosyltransferase 2 alpha (MAT2A) in solid tumors with MTAP deletion, a condition prevalent in 15% of solid tumors. The IDE397 program includes both monotherapy and combination trials with other investigational drugs.
Financially, IDEAYA is robust with cash reserves exceeding $941.4 million as of Q1 2024, ensuring operational funding through 2028. Key investors include 5AM Ventures, Canaan Partners, and Celgene. The company has formed strategic collaborations with major pharmaceutical players like Pfizer, Amgen, Gilead Sciences, GSK, and Merck to amplify its research and clinical capabilities.
IDEAYA's scientific advisory board is composed of esteemed researchers, including a Nobel laureate and members of the National Academy of Sciences, underscoring the company's commitment to groundbreaking research.
Recent developments are promising: IDEAYA reported favorable Phase 2 trial results for IDE196 in UM, with significant tumor reduction and eye preservation rates. Additionally, a collaboration with Merck for the IDE161 program aims to tackle endometrial cancer using advanced immunotherapy combinations.
For more detailed updates and financial information, visit IDEAYA's Investor Relations page.
On April 24, 2023, IDEAYA Biosciences (Nasdaq: IDYA) announced a public offering of common stock, pricing 7,439,201 shares at $18.50 each, alongside pre-funded warrants for an additional 2,020,270 shares at $18.4999 each. The total expected gross proceeds from the offering are approximately $175 million before deductions. Underwriters J.P. Morgan, Jefferies, and Citigroup are overseeing the offering, which is anticipated to close around April 27, 2023, pending customary conditions. Additionally, the company has granted underwriters a 30-day option to purchase up to 1,418,920 more shares at the offering price. This public offering is conducted under a previously filed shelf registration statement with the SEC.
IDEAYA Biosciences (NASDAQ: IDYA) has announced its intention to conduct an underwritten public offering of common stock, aiming to raise up to $150 million. The offering will also include a 30-day option for underwriters to purchase an additional $22.5 million in shares. The offering's completion is subject to market conditions, and no assurance is provided regarding its final terms. Leading the offering are J.P. Morgan, Jefferies, and Citigroup as joint book-running managers. The securities will be offered under a previously filed shelf registration statement, and a prospectus supplement will be available on the SEC's website. This press release serves as a preliminary notice and does not constitute a sale offer.
IDEAYA Biosciences announced promising interim results from its Phase 2 clinical trial of darovasertib and crizotinib in metastatic uveal melanoma (MUM) patients, presenting a confirmed overall response rate (ORR) of 45% and a median progression-free survival (PFS) of approximately 7 months in 20 evaluable first-line patients. The disease control rate (DCR) stood at 90%. The FDA provided positive guidance for a Phase 2/3 registrational trial aimed at HLA-A2 negative MUM patients, potentially leading to accelerated approval. Notably, the trial showed 35% ORR in hepatic-only MUM patients and a DCR of 100%. The treatment was well tolerated, with a manageable adverse event profile. IDEAYA has $373 million in cash, sufficient to fund operations into 2026.
IDEAYA Biosciences has initiated a Phase 1 clinical trial evaluating IDE161, a selective PARG inhibitor, in patients with homologous recombination deficiency (HRD) solid tumors, particularly focusing on ER+ / Her2- breast cancer.
This trial, marked by the dosing of the first patient, aims to assess the drug's safety, tolerability, and preliminary efficacy as a monotherapy. IDE161 holds potential as a treatment for approximately 10% to 14% of breast cancer patients with HRD, who currently have limited treatment options.
Presented at AACR 2023, this research outlines IDE161's promise and the company's plans for expansion into various HRD tumor cohorts, emphasizing its strategic focus on precision medicine in oncology.
IDEAYA Biosciences, Inc. (NASDAQ: IDYA) announced its participation in investor relations events, including a fireside chat at Cantor's The Future of Oncology Virtual Symposium on April 4, 2023, at 2:15 PM ET. The discussion features CEO Yujiro Hata and is hosted by Li Watsek. Interested parties can access a live audio webcast through the IDEAYA website. The company focuses on precision medicine and synthetic lethality, aiming to develop targeted therapeutics using molecular diagnostics. IDEAYA emphasizes the importance of identifying patient populations most likely to benefit from its therapies.
On March 30, 2023, IDEAYA Biosciences (NASDAQ: IDYA) granted stock options for 79,700 shares to two newly hired employees under the 2023 Employment Inducement Incentive Award Plan. This action complies with Nasdaq Listing Rule 5635(c)(4), which allows the use of this plan for non-former employees. The stock options have an exercise price of $13.49 per share, equal to the closing price on the grant date, and feature a 10-year term with four-year vesting. This development reinforces IDEAYA's commitment to its workforce as it advances its targeted therapeutics in precision medicine oncology.
IDEAYA Biosciences (NASDAQ: IDYA) announced the publication of abstracts for its synthetic lethality programs at the 2023 AACR Annual Meeting. The company will present data on IDE397, a MAT2A inhibitor, and IDE161, a PARG inhibitor, both in Phase 1/2 trials, along with a preclinical Werner Helicase program. Notable presentations include dual inhibition of MAT2A and PRMT5, and targeting HRD breast and ovarian tumors. IDEAYA is collaborating with Amgen and GSK for these programs. The company aims for further clinical developments and eligibility for up to $10 million in milestone payments in connection with its Werner Helicase program.
IDEAYA Biosciences reported a strong cash position of approximately $373.1 million as of December 31, 2022, sufficient to fund operations into 2026. The company is advancing its lead program, darovasertib, targeting ocular melanoma, with regulatory updates anticipated after a Q1 2023 FDA meeting. Clinical updates for darovasertib are expected mid-year 2023, aiming for an overall response rate >20% and a median progression-free survival >5 months. IDEAYA also plans IND submissions for IDE161 and Pol Theta Helicase candidates in 2023, alongside collaborations with GSK and Amgen to expand its pipeline.
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