IDYA IDEAYA Biosciences Inc.

22.92
+0.24  (+1%)
Previous Close 22.68
Open 22.56
52 Week Low 12.01
52 Week High 28
Market Cap $880,191,511
Shares 38,402,771
Float 34,383,161
Enterprise Value $598,548,541
Volume 131,036
Av. Daily Volume 328,977
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Upcoming Catalysts

Drug Stage Catalyst Date
Darovasertib (IDE196) and MEKTOVI (​binimetinib)
Metastatic uveal melanoma (MUM)
Phase 1/2
Phase 1/2
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Darovasertib (IDE196) and XALKORI (crizotinib)
Metastatic uveal melanoma (MUM)
Phase 1
Phase 1
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IDE397
Solid tumors
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
Darovasertib (IDE196) - (basket)
Solid tumors
Phase 2
Phase 2
Observed tumor reduction in 80% (n=4) of 5 evaluable skin melanoma patients

Latest News

  1. SOUTH SAN FRANCISCO, Oct. 18, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced that Michael White, Ph.D., will join the company as its Chief Scientific Officer, effective November 1, 2021. 

    "We are thrilled to welcome Dr. White, and we believe his deep industry experience as CSO and Head of Tumor Biology at Pfizer, and extensive knowledge in cancer biology developed during a prolific academic career at UT Southwestern, will enable IDEAYA to extend its position as the industry leader in the emerging field of synthetic lethality.  Under Dr. White's leadership we will continue to enhance IDEAYA's synthetic lethality platform and advance our next generation synthetic lethality pipeline, including in biomarker populations beyond HRD, such as MTAP, as well as utilizing both small molecule inhibitor and protein degrader drug discovery approaches," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

    "I am excited to join IDEAYA to help advance the company's strategic vision to discover and develop potential first-in-class and best-in-class synthetic lethality-based precision therapies for oncology.  This emerging realm of precision medicine holds considerable potential to deliver new treatments for cancer patients with unmet need, particularly for those harboring disease that emerges from loss-of-function genetic alterations that are otherwise undruggable.  A prominent example is MTAP-deletion, where IDEAYA is well-positioned to be an industry leader with continued advancement of the potential best-in-class Phase 1 MAT2A inhibitor IDE397 and potential novel synthetic lethality combinations," said Dr. Michael White

    Dr. White formerly served as Chief Scientific Officer and Head of Tumor Biology at Pfizer, Inc., where he led cross-disciplinary groups to build an oncology small-molecule pipeline focused on first-in-class therapies, culminating in numerous INDs.  Prior to joining Pfizer, Dr. White had a prolific over twenty-year academic career at UT Southwestern where he was a Professor of Cell Biology and founding Director of the Cancer Intervention and Prevention Discovery Program.  In 2015, Dr. White received the inaugural Outstanding Investigator's Award from the National Cancer Institute (NCI), the U.S. Government's principal agency for cancer research, and has authored over 150 publications with over 22,000 citations.  Dr. White received his Ph.D. in Biology from the University of North Carolina at Chapel Hill and completed postdoctoral research at Cold Spring Harbor Laboratories in New York.

    Dr. White succeeds Dr. Michael Dillon, who joined IDEAYA in 2016.  Dr. Dillon served as Chief Scientific Officer since 2018, and announced his plans to transition in late 2019.  "We thank Dr. Dillon for his extensive contributions, and we wish him the best in his future endeavors," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

    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. 

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to (i) the anticipated starting date of Dr. White and (ii) the impact Dr. White will have on IDEAYA's programs. 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 August 10, 2021 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

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    SOURCE IDEAYA Biosciences, Inc.

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  2. SOUTH SAN FRANCISCO, Calif., Aug. 30, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in investor conferences in September 2021.

    Citi's 16th Annual BioPharma Virtual Conference

    Yujiro Hata, Chief Executive Officer, will participate in a panel discussion entitled "Aiming for the Bull's Eye – Latest Advances in Targeted Oncology" on Friday, September 10, 2021 at 9:45am ET.  The panel discussion will be hosted by Yigal Nochomovitz, Ph.D. Director, Equity Research.  The panelists include:

    Yujiro Hata, Chief Executive Officer, IDEAYA Biosciences

    Terry Rosen, Chief Executive Officer, Arcus Biosciences

    Jacob Chacko, Chief Executive Officer, ORIC Pharmaceuticals

    Avanish Vellanki, Chief Executive Officer, Rain Therapeutics

    Briggs Morrison, Chief Executive Officer, Syndax Pharmaceuticals

    H.C. Wainwright 23rd Annual Global Investment Conference

    Paul Stone, Chief Financial Officer, will present on Monday, September 13, 2021 at 7:00am ET

    R. W. Baird 2021 Virtual Global Healthcare Conference

    Fireside chat with Yujiro Hata, Chief Executive Officer hosted by Joel Beatty, M.D. C.F.A., Senior Research Analyst

    Wednesday, September 15, 2021 at 4:20pm ET

    2021 Cantor Virtual Global Healthcare Conference

    Paul Stone, Chief Financial Officer, will present on Thursday, September 30, 2021 at 11:20am ET

    A live audio webcast of each event 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.

    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. 

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to participation in and/or presentation at certain investor relations events. 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 August 10, 2021 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-to-participate-in-investor-conferences-in-september-2021-301364421.html

    SOURCE IDEAYA Biosciences, Inc.

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  3. SOUTH SAN FRANCISCO, Calif., Aug. 10, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, provided a business update and announced financial results for the second quarter ended June 30, 2021.

    "We reported clinical data across multiple programs in the second quarter of 2021, including early clinical pharmacodynamic data for IDE397 in MTAP-deletion patients, as well as overall survival data for darovasertib monotherapy and early clinical efficacy for the darovasertib / binimetinib and darovasertib / crizotinib combinations in metastatic uveal melanoma patients.  We also continued to advance our broad synthetic lethality pipeline and platform, with two potential development candidates anticipated in the fourth quarter of 2021 and multiple potential first-in-class preclinical targets and programs advancing against genetically defined patient populations.  These clinical data and our synthetic lethality pipeline demonstrate our clinical progress and commitment to deliver precision medicine oncology therapies to patients with high unmet medical needs," said Yujiro S. Hata, Chief Executive Officer and President of IDEAYA Biosciences.  

    Program Updates

    Key highlights for IDEAYA's pipeline programs include:

    IDE397 (MAT2A)

    IDEAYA is evaluating IDE397, a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A), in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion, a patient population estimated to represent approximately 15% of solid tumors.   IDEAYA is leading early clinical development of IDE397.  Subject to exercise of its option, GlaxoSmithKline (GSK) will lead later stage global clinical development.  Highlights:

    • Actively enrolling patients into the dose escalation and tumor biopsy cohorts of the Phase 1 clinical trial IDE397-001 (ClinicalTrials.gov Identifier: NCT04794699)
    • Patients are being identified by next generation sequencing (NGS) or by MTAP immunohistochemistry (IHC) assay with confirmatory NGS
    • Enrolled patients having multiple solid tumor types with MTAP-deletion, including non-small cell lung cancer, pancreatic cancer, thymic cancer and adenoid cystic carcinoma
    • IDE397 has been generally well tolerated, with observed drug-related adverse events as of June 25, 2021 of only grade 1 drug-related adverse events, including constipation, nausea and fatigue; there were no reported drug-related serious adverse events and no reported myelosuppression, or changes to bilirubin or to aminotransaminase (AST) or alanine aminotransferase (ALT) enzymes
    • Observed reduction of plasma S-adenosylmethionine, or SAM, a proximal pharmacodynamic marker, in each of the first two cohorts of the IDE397 Phase 1 dose escalation study, satisfying the clinical protocol threshold of approximately 60% or greater to initiate the tumor biopsy cohort of the IDE397 Phase 1 clinical trial
    • Targeting initiation of the tumor biopsy cohort in the third quarter of 2021 to evaluate tumor PD biomarkers, including tumor SAM as well as tumor symmetric dimethylarginine, or SDMA.
    • Targeting to obtain additional PD data, including plasma SAM, tumor SAM and tumor SDMA, in the fourth quarter of 2021
    • Subject to satisfactory completion of the dose escalation portion of the Phase 1 clinical trial, IDEAYA plans to enroll MTAP deletion patients into expansion arms in NSCLC and potentially in other solid tumor indications such as esophageal, gastric, bladder, head and neck, or pancreatic cancers
    • Demonstrated preclinical efficacy of monotherapy IDE397 in a study of over forty solid tumor patient derived xenograft (PDX) models with homozygous MTAP deletions across a range of solid tumor types, including NSCLC, esophageal, gastric, bladder, head and neck, and pancreatic cancers; study data was reported at AACR 2021
    • Observed preclinical in vivo efficacy of IDE397 in combination with a taxane, showing enhanced TGI in pancreatic cancer PDX models

    PARG

    IDEAYA is advancing preclinical research for an inhibitor of poly (ADP-ribose) glycohydrolase (PARG) in patients having tumors with a defined biomarker based on genetic mutations and/or molecular signature.   PARG is a novel target in the same clinically validated biological pathway as poly (ADP-ribose) polymerase (PARP).  IDEAYA owns or controls all commercial rights in its PARG program.  Highlights:

    • Identified a novel and proprietary HRD biomarker to guide patient selection, with validation in vitro and in vivo in CDX models across multiple solid tumor indications
    • Demonstrated PARGi dose-dependent in vivo efficacy as monotherapy with tumor regression or stasis in ovarian, gastric and breast cancer CDX models
    • Observed in vivo efficacy with enhanced TGI or tumor regressions relative to niraparib, a PARPi, in multiple CDX models, including in a niraparib-resistant CDX model
    • Showed tumor regressions in multiple breast cancer PDX models with defined genetic and subtyping profiles, including in niraparib resistant PDX models
    • Showed pharmacological inhibition of PARG in a panel of homologous recombination deficient cell lines and in CDX and PDX models; study data reported at AACR 2021
    • Subject to further preclinical studies, IDEAYA is targeting to identify a PARG inhibitor development candidate in the fourth quarter of 2021

    Pol Theta

    IDEAYA's DNA Polymerase Theta, (Pol Theta) program targets tumors with BRCA or other homologous recombination deficiency, or HRD, mutations.  IDEAYA and GSK are collaborating on ongoing preclinical research, including small molecules and protein degraders, and GSK will lead clinical development for the Pol Theta program.   Highlights:

    • Demonstrated in vivo efficacy with tumor regression in BRCA2 -/- xenograft model with IDEAYA Pol Theta inhibitor in combination with niraparib, a GSK PARP inhibitor; and
    • Subject to further preclinical studies, IDEAYA is targeting selection of a Pol Theta inhibitor development candidate in the fourth quarter of 2021

    Werner Helicase

    IDEAYA is advancing preclinical research for an inhibitor targeting Werner Helicase for tumors with high microsatellite instability (MSI). IDEAYA and GSK are collaborating on ongoing preclinical research, and GSK will lead clinical development for the Werner Helicase program.   Highlights:

    • observed dose-dependent cellular viability effect and dose-dependent cellular PD response in multiple endogenous MSI high cell lines
    • Demonstrated efficacy and PD response in relevant MSI high in vivo models

    Other Synthetic Lethality Pipeline Programs

    IDEAYA is advancing additional preclinical research programs to identify small molecule inhibitors for an MTAP-synthetic lethality target, as well as for multiple distinct DNA Damage Targets for patients with solid tumors characterized by proprietary biomarkers or gene signatures.

    Darovasertib (IDE196)

    IDEAYA continues to execute on its clinical trial strategy to evaluate darovasertib (IDE196), a potent and selective PKC inhibitor. 

    IDEAYA is evaluating darovasertib in metastatic uveal melanoma (MUM) as monotherapy and in combination therapies, including combinations of darovasertib / binimetinib and independently, darovasertib / crizotinib.  The company is continuing to enroll MUM patients into each of the combination arms of the Phase 1/2 clinical trial and is targeting to provide a clinical data update for the darovasertib combination(s) in the fourth quarter of 2021.

    IDEAYA is planning to seek FDA regulatory guidance for darovasertib monotherapy based on observed overall survival data in MUM in the second half of 2021, and/or for darovasertib combination(s) on potential registration-enabling trial design in MUM in the first half of 2022. 

    The company is also evaluating darovasertib as monotherapy outside of MUM, with a focus in GNAQ/11-mutation skin melanoma.    

    Darovasertib Monotherapy

    IDEAYA has completed enrollment into its ongoing Phase 1/2 clinical trial evaluating darovasertib as monotherapy in MUM patients.  The company is continuing enrollment into its ongoing basket trial evaluating darovasertib as monotherapy in patients having non-MUM tumors harboring GNAQ or GNA11 activating mutations.  The company's development strategy in the monotherapy non-MUM GNAQ/11 arm of the clinical trial is focused on skin melanoma. Highlights:

    • Clinical data from Phase 1/2 clinical trial arm evaluating monotherapy darovasertib in MUM patients showed 57% 1-year overall survival (OS) with 95% confidence interval (44%, 69%) and median OS of 13.2 months with 95% confidence interval (10.7 months, not reached), in predominantly 2L/3L and heavily pretreated to 7L/8L patients, as of data and analyses cutoff on April 13, 2021 based on preliminary data from an unlocked database (n=81 patients evaluable for safety and n=75 patients evaluable for efficacy pursuant to RECIST 1.1 guidelines)
    • Historical 37% 1-year OS and median OS of ~7 months have been reported in similar 2L/3L+ MUM patient population (Rantala 2019)
    • Clinical data from Phase 1/2 clinical basket trial arm evaluating monotherapy darovasertib in skin melanoma patients showed tumor reduction in 80% (n=4) of 5 evaluable skin melanoma patients pursuant to RECIST1.1 guidelines, including one confirmed PR, as of data and analyses cutoff of April 13, 2021 based on preliminary data from an unlocked database (n=7 patients evaluable for safety and n=5 patients evaluable for efficacy pursuant to RECIST 1.1 guidelines)
    • An aggregate of 88 patients were evaluable for safety across Phase 1/2 arms evaluating darovasertib in MUM and skin melanoma patients. As of the April 13, 2021 data and analyses cutoff, and based on preliminary data from an unlocked database, the overall safety profile of darovasertib monotherapy is consistent with prior experience and includes primarily common low grade but manageable GI and skin toxicities
    • Preliminary clinical data from darovsertib monotherapy arm shows that darovasertib activity is independent of HLA status

    Darovasertib / Binimetinib Combination Therapy

    IDEAYA is continuing patient enrollment into the darovasertib / binimetinib combination arm of the Phase 1/2 clinical trial under the clinical trial collaboration and supply agreement with Pfizer.  Highlights:

    • Clinical data from Phase 1/2 clinical trial arm evaluating the darovasertib / binimetinib combination in MUM patients showed 22% (n=2) partial responses (PR), including one confirmed PR and one unconfirmed PR who confirmed with a 51.7% tumor reduction in a subsequent scan, out of nine evaluable MUM patients with at least two post-baseline scans pursuant to RECIST 1.1 guidelines, in predominantly second line, third line (2L / 3L) or later lines of treatment, as of data and analyses cutoff of April 13, 2021 based on preliminary data from an unlocked database (n=24 patients evaluable for safety and n=14 patients evaluable for efficacy)
    • Drug-related adverse events observed in the darovasertib and binimetinib combination arm in MUM, as of April 13, 2021 data and analyses cutoff based on preliminary data from an unlocked database, primarily include: serious adverse events of liver toxicity, nausea and vomiting, and syncope; and adverse events that occurred in greater than 10% of patients of nausea, vomiting, diarrhea, rash, edema, aminotransaminase, or AST increase, alanine aminotransferase, or ALT, increase and creatine phosphokinase increase

    Darovasertib / Crizotinib Combination Therapy

    IDEAYA is continuing patient enrollment into the darovasertib / crizotinib combination arm of the Phase 1/2 clinical trial under the clinical trial collaboration and supply agreement with Pfizer.   Highlights:

    • Initiated dose expansion for a cohort of the Phase 1/2 darovasertib / crizotinib combination arm in MUM, with additional dose exploration ongoing
    • Clinical data from the darovasertib and crizotinib combination in MUM patients showed one unconfirmed PR in a third-line patient, who confirmed with a 56.5% tumor reduction in a subsequent scan, as of data and analyses cutoff on May 5, 2021 based on preliminary data from an unlocked database (n=6 patients evaluable for safety and n=2 patients evaluable for response with at least one post-baseline scan)
    • Drug-related adverse events observed in the darovasertib and crizotinib combination arm in MUM as of May 5, 2021, based on preliminary data from an unlocked database, primarily include: serious adverse events of syncope and hypotension, each of which resolved with patients continuing dosing; and adverse events that occurred in at least two of the six treated patients of nausea, diarrhea, vomiting, edema, decreased appetite, and syncope
    • Amended Pfizer clinical trial collaboration and supply agreement to enable expansion for 40 additional patients on darovasertib / crizotinib combination
    • Observed preclinical synergies between darovasertib and crizotinib in relevant cellular models under conditions simulating a tumor microenvironment in the liver, the site of approximately 90% of uveal melanoma metastases; study data reported at AACR 2021
    • Correlated cMET expression and activation to observed clinical response based on a retrospective analysis of human clinical biopsies from the Novartis darovasertib Phase 1 clinical trial, supporting cMET expression / activation as potential combination agent

    Darovasertib – Other Potential Indications

    IDEAYA is evaluating the potential for darovasertib in GNAQ mutation-mediated rare diseases, including Sturge-Weber Syndrome (SWS) and Port Wine Stains (PWS), neurocutaneous disorders characterized by capillary malformations and associated with mutations in GNAQ.  The US/EU5 prevalence of SWS patients who may potentially benefit from chronic treatment is approximately 13,000 to 33,000 patients.  PWS is a potential related indication with an estimated US/EU5 prevalence of patients with extensive involvement – who have port-wine-stain over the trunk and extremities as well as the head and neck, of approximately 235,000 patients.  Highlights:

    • Targeting FDA clearance in the first half of 2022 to initiate a Phase 1 clinical trial to evaluate darovasertib in SWS and extensive involvement of PWS populations

    General

    IDEAYA continues to monitor Covid-19 and its potential impact on clinical trials and timing of clinical data results.  Initiation of clinical trial sites, patient enrollment and ongoing monitoring of enrolled patients, including obtaining patient computed tomography (CT) scans, may be impacted for IDEAYA clinical trials evaluating IDE397 and darovasertib; the specific impacts are currently uncertain.

    Corporate Updates

    IDEAYA's net losses were $10.9 million and $9.0 million for the three months ended June 30, 2021 and March 31, 2021, respectively. As of June 30, 2021, the company had an accumulated deficit of $147.0 million.

    As of June 30, 2021, IDEAYA had cash, cash equivalents and marketable securities of $312.4 million. IDEAYA supplemented its second-quarter-end cash, cash equivalents and marketable securities with an additional $86.5 million in aggregate net proceeds, after deducting underwriting discounts and commissions but before deducting other offering expenses, received subsequent to quarter end from the sale and issuance of 5,333,333 shares of common stock at an offering price of $17.25 per share pursuant to an underwritten public offering, including 695,652 shares of common stock upon the exercise in full of the overallotment option by the underwriters.

    IDEAYA believes that its cash, cash equivalents and marketable securities will be sufficient to fund our planned operations into 2025. These funds will support the company's efforts through potential achievement of multiple preclinical and clinical milestones across multiple programs.

    Our updated corporate presentation is available on our website, at our Investor Relations page: https://ir.ideayabio.com/.

    Financial Results

    As of June 30, 2021, IDEAYA had cash, cash equivalents and short-term marketable securities totaling $312.4 million. This compared to cash, cash equivalents and short-term and long-term marketable securities of $310.4 million at March 31, 2021. The increase was primarily due to $15.4 million in net proceeds received during the three months ended June 30, 2021 from issuance of common stock under at-the-market offerings pursuant to the January 2021 Sales Agreement with Jefferies as sales agent, offset by cash used in operations and purchases of property and equipment.

    Collaboration revenue for the three months ended June 30, 2021 totaled $8.8 million compared to $7.2 million for the three months ended March 31, 2021. Collaboration revenue was recognized for the performance obligations satisfied through June 30, 2021 under the GSK Collaboration Agreement.

    Research and development (R&D) expenses for the three months ended June 30, 2021 totaled $15.0 million compared to $11.6 million for the three months ended March 31, 2021. The increase was primarily due to an increase in fees to CROs, CMOs and external consultants related to our lead product candidates, an increase in R&D headcount costs, an increase in external clinical development expenses for darovasertib and an increase in costs for laboratory supplies used in support of our research programs, offset by a decrease in external clinical development expenses for IDE397.

    General and administrative (G&A) expenses for the three months ended June 30, 2021 totaled $4.8 million compared to $4.8 million for the three months ended March 31, 2021. An increase due to G&A headcount costs was offset by a decrease in costs associated with audit fees for the comparative periods.

    The net loss for the three months ended June 30, 2021 was $10.9 million compared to $9.0 million for the three months ended March 31, 2021. Total stock compensation expense for the three months ended June 30, 2021 was $2.1 million compared to $1.9 million for the three months ended March 31, 2021.

    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.  IDEAYAs 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.   

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to (i) the timing of initiating the tumor biopsy cohort to evaluate tumor PD biomarkers and obtaining clinical PD data in the IDE397 monotherapy Phase 1 clinical trial, (ii) the timing of identification of a development candidate for a PARG in inhibitor, (iii) the timing of identification of a development candidate for a Pol Theta inhibitor, (iv) the timing of a clinical data update for darovasertib combination(s), (v) the timing for obtaining FDA clearance to initiate a Phase 1 clinical trial to evaluate darovasertib in GNAQ mutation-mediated rare diseases, (vi) the enrollment of patients with certain tumor types in the IDE397 monotherapy Phase 1 clinical trial, (vii) the timing of obtaining FDA guidance for potential darovasertib registrational pathway, (viii) the impact of COVID-19, and (ix) 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, the effects on IDEAYA's business of the worldwide COVID-19 pandemic, 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 recent Quarterly Report on Form 10-Q filed on August 10, 2021 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    IDEAYA Biosciences, Inc.

    Condensed Statements of Operations and Comprehensive Loss

    (in thousands, except share and per share amounts)







    Three Months Ended





    Six Months Ended







    June 30,

    2021





    March 31,

    2021





    June 30,

    2021





    June 30,

    2020



    Collaboration revenue



    $

    8,756





    $

    7,247





    $

    16,003





    $



    Operating expenses

































    Research and development





    14,979







    11,566







    26,546







    17,622



    General and administrative





    4,828







    4,816







    9,643







    7,446



    Total operating expenses





    19,807







    16,382







    36,189







    25,068



    Loss from operations





    (11,051)







    (9,135)







    (20,186)







    (25,068)



    Interest income and other income (expense),

        net





    104







    114







    218







    634



    Net loss



    $

    (10,947)





    $

    (9,021)





    $

    (19,968)





    $

    (24,434)



    Change in unrealized gains (losses) on

        marketable securities





    (4)







    (7)







    (11)







    (8)



    Comprehensive loss



    $

    (10,951)





    $

    (9,028)





    $

    (19,979)





    $

    (24,442)



    Net loss per share attributable to common

        stockholders, basic and diluted



    $

    (0.33)





    $

    (0.28)





    $

    (0.62)





    $

    (1.18)



    Weighted average number of shares

        outstanding, basic and diluted





    32,854,926







    31,761,207







    32,321,481







    20,626,139



     

    IDEAYA Biosciences, Inc.

    Condensed Balance Sheet Data

    (in thousands)







    June 30,





    December 31,







    2021





    2020



    Cash and cash equivalents and short-term and long-term

         marketable securities



    $

    312,430





    $

    283,585



    Total assets





    328,401







    298,269



    Total liabilities





    88,141







    99,995



    Total liabilities and stockholders' equity





    328,401







    298,269



     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-inc-reports-second-quarter-2021-financial-results-and-provides-business-update-301351733.html

    SOURCE IDEAYA Biosciences, Inc.

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  4. SOUTH SAN FRANCISCO, Calif., Aug. 2, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in a panel discussion at the 2021 Wedbush PacGrow Healthcare Virtual Conference on August 10, 2021.

    2021 Wedbush PacGrow Healthcare Virtual Conference

    "Synthetic Lethal (Weapon)" panel discussion Tuesday, August 10, 2021 at 11:30 am ET

    Panelists include:

    • Michael Dillon, Senior Vice President and Chief Scientific Officer, Head of Research, IDEAYA Biosciences
    • Markus Renschler, President and CEO, Cyteir Therapeutics
    • Vatnak Vat-Ho, CBO, Ryvu Therapeutics
    • Barbara Weber, Chief Executive Officer, Tango Therapeutics

    A live audio webcast of the event will be available by visiting the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at https://ir.ideayabio.com/events.  A replay of the webcast will be available for 30 days following the live event.

    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. 

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to participation in and/or presentation at certain investor relations events. 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 May 10, 2021 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

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    SOURCE IDEAYA Biosciences, Inc.

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  5. SOUTH SAN FRANCISCO, Calif., July 12, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA) today announced the closing of its underwritten public offering of 5,333,333 shares of its common stock at a public offering price of $17.25 per share, before underwriting discounts and commissions, including the exercise in full by the underwriters of their option to purchase up to an additional 695,652 shares of common stock in the offering. The net proceeds from the offering were approximately $86.1 million, after deducting the underwriting discount and commissions and estimated offering expenses payable by IDEAYA.  All shares in the offering were offered by IDEAYA.

    SOUTH SAN FRANCISCO, Calif., July 12, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA) today announced the closing of its underwritten public offering of 5,333,333 shares of its common stock at a public offering price of $17.25 per share, before underwriting discounts and commissions, including the exercise in full by the underwriters of their option to purchase up to an additional 695,652 shares of common stock in the offering. The net proceeds from the offering were approximately $86.1 million, after deducting the underwriting discount and commissions and estimated offering expenses payable by IDEAYA.  All shares in the offering were offered by IDEAYA.

    IDEAYA intends to use the net proceeds of the offering, along with its existing cash, cash equivalents and short-term and long-term marketable securities to fund (i) clinical development of IDE397, its MAT2A inhibitor development candidate, (ii) preclinical and clinical development of other product candidates in its research pipeline targeting poly (ADP-ribose) glycohydrolase, or PARG, a MTAP synthetic lethality target (other than MAT2A), and DNA damage targets, as well as its share of costs for targeting WRN under IDEAYA's Collaboration, Option and License Agreement with GSK, (iii) ongoing early clinical development of darovasertib (IDE196), its PKC inhibitor, in metastatic uveal melanoma, or MUM, and other solid tumors having GNAQ/11 hotspot mutations, including as monotherapy and as combination therapies with binimetinib, a MEK inhibitor, and independently with crizotinib, in each case pursuant to a clinical trial and drug supply agreement with Pfizer, (iv) synthetic lethality target and biomarker research and development activities and (v) working capital and other general corporate purposes.

    J.P. Morgan, Citigroup, Jefferies and Guggenheim Securities acted as joint book-running managers for the offering.  

    The public offering was made by IDEAYA pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the U.S. Securities and Exchange Commission, or the SEC. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC's website at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by request from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or by email at prospectus-eq_fi@jpmorganchase.com; Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at Prospectus_Department@Jefferies.com; or Guggenheim Securities, by mail at Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, or by telephone at (212) 518-5548 or by email at gsequityprospectusdelivery@guggenheimpartners.com.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    ___________________

    About IDEAYA Biosciences

    IDEAYA is 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 small molecule drug discovery with extensive capabilities in identifying and validating translational biomarkers to develop targeted therapies for select patient populations most likely to benefit. IDEAYA is applying these capabilities to develop a robust pipeline in precision medicine oncology, with a research focus in synthetic lethality—which represents an emerging class of precision medicine targets.

    ___________________

    Legal Notice Regarding Forward-Looking Statements

    This press release contains forward-looking statements. All statements other than statements of historical facts contained herein, including without limitation statements regarding the expected use of proceeds from the public offering, are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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, the effects on IDEAYA's business of the worldwide COVID-19 pandemic, 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 recent Quarterly Report on Form 10-Q filed on May 10, 2021, the final prospectus supplement related to the proposed public offering and subsequent filings with the SEC.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-announces-closing-of-public-offering-of-common-stock-and-full-exercise-of-underwriters-option-to-purchase-additional-shares-301331875.html

    SOURCE IDEAYA Biosciences, Inc.

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