1. 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.

    View Full Article Hide Full Article
  2. 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.

    View Full Article Hide Full Article
  3. 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.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-to-participate-in-panel-discussion-at-2021-wedbush-pacgrow-healthcare-virtual-conference-on-august-10-2021-301344774.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  4. 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.

    View Full Article Hide Full Article
  5. SOUTH SAN FRANCISCO, Calif., July 7, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA) today announced the pricing of an underwritten public offering of 4,637,681 shares of its common stock at a public offering price of $17.25 per share, before underwriting discounts and commissions. In addition, IDEAYA has granted the underwriters a 30-day option to purchase up to an additional 695,652 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by IDEAYA, are expected to be approximately $80.0 million, excluding any exercise of the underwriters' option to purchase additional…

    SOUTH SAN FRANCISCO, Calif., July 7, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA) today announced the pricing of an underwritten public offering of 4,637,681 shares of its common stock at a public offering price of $17.25 per share, before underwriting discounts and commissions. In addition, IDEAYA has granted the underwriters a 30-day option to purchase up to an additional 695,652 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by IDEAYA, are expected to be approximately $80.0 million, excluding any exercise of the underwriters' option to purchase additional shares. The offering is expected to close on or about July 12, 2021, subject to the satisfaction of customary closing conditions.

    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 are acting as joint book-running managers for the offering.  

    The securities described above are being offered 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 is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, copies of which may be obtained, when available, 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 closing of the public offering and 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 preliminary 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-pricing-of-public-offering-of-common-stock-301327523.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  6. SOUTH SAN FRANCISCO, Calif., July 6, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA) today announced that it intends to offer and sell up to $80 million of shares of its common stock in an underwritten public offering. In addition, IDEAYA intends to grant the underwriters a 30-day option to purchase up to $12 million of shares of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    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 the Company'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 are acting as joint book-running managers for the offering.

    The securities described above are being offered 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 (the "SEC"). The offering will be made only by means of a written prospectus and a prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's website. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities 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, or by email at prospectus@citi.com; 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 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 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 offer and sale of shares, the terms of the offering and expected use of proceeds 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, risks and uncertainties related to market conditions and the satisfaction of closing conditions related to the proposed public offering, 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 preliminary 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-proposed-public-offering-of-common-stock-301326301.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  7. SOUTH SAN FRANCISCO, Calif., June 28, 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 updates for its Phase 1 clinical trial evaluating IDE397 in patients having solid tumors with MTAP deletion and Phase 1/2 clinical trial evaluating darovasertib combination therapies in metastatic uveal melanoma (MUM).

    "The observation of a clinical pharmacodynamic signal in the initial cohorts of the IDE397 dose escalation study is significant.  Modulation of plasma SAM is evidence of target engagement and supports our preclinical observations that IDE397 is a highly potent and active MAT2A inhibitor," said Mark Lackner, Ph.D., Senior Vice President, Head of Biology and Translational Sciences of IDEAYA Biosciences.

    "We continue to be encouraged by the early clinical responses observed in the daraovasertib combination treatments in heavily pretreated patients and are excited to initiate our Phase 2 clinical trial to further evaluate the darovasertib and crizotinib combination in MUM patients," said Matthew Maurer, M.D., Vice President, Head of Clinical Oncology and Medical Affairs, IDEAYA Biosciences.

    IDE397 in MTAP Deletion Solid Tumors

    IDEAYA is evaluating IDE397, a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A), as monotherapy in the dose escalation portion of a Phase 1 clinical trial in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion, a patient population estimated to represent approximately 15% of solid tumors. 

    The company is currently enrolling patients in the third cohort of the dose escalation portion of the IDE397 clinical trial.  Four clinical trial sites are currently open for enrollment with an additional five sites targeted in the second half 2021.  IDEAYA has entered into a collaboration with Tempus Labs to identify additional patients for the open clinical sites.  The enrolled patients have tumors with MTAP deletion in non-small cell lung cancer (NSCLC), pancreatic cancer and thymic cancer.  As of June 25, 2021, IDE397 has been generally well tolerated with 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.

    IDEAYA has met the criteria to initiate a IDE397 tumor biopsy cohort arm in each of the first two cohorts of the dose escalation study, with observed clinical pharmacodynamic (PD) modulation of plasma S-adenosyl methionine (SAM) satisfying the clinical protocol threshold of approximately 60% or greater.  The PD data showed a maximal plasma SAM reduction from baseline of 68.9% and 88.0% for the first (n=2) and second (n=3) cohorts, respectively.  The clinical protocol threshold was established based on IDE397 preclinical in vivo efficacy data in MTAP-deletion xenograft models.  The company plans to obtain pre-treatment and post-treatment tumor biopsies from patients enrolled into this tumor biopsy cohort to evaluate tumor PD response, including measurement of tumor SAM and tumor symmetric dimethyl arginine (SDMA) biomarkers. 

    The PD data to be obtained from the IDE397 tumor biopsy cohort is expected to support an option data package for review by GlaxoSmithKline (GSK) in consideration of whether to exercise its exclusive option to develop and commercialize IDE397.  The GSK option is exercisable within a certain period after IDEAYA delivers a data package comprising preclinical data and clinical data from the IDE397 monotherapy dose escalation portion of the Phase 1 clinical trial, including safety and tolerability data, pharmacokinetic data, and pharmacodynamic modulation of SAM and tumor SDMA.  IDEAYA is leading early clinical development of IDE397.  If GSK exercises its option and pays an option exercise fee of fifty million dollars ($50,000,000), GSK will lead later stage global clinical development and costs will be shared with GSK responsible for 80% and IDEAYA responsible for 20%.  If GSK exercises the option, IDEAYA will be eligible to receive future development and regulatory milestones of up to $465 million, 50% of U.S. net profits, tiered royalties on global ex-U.S. net sales ranging from high single digit to sub-teen double digit percentages and certain commercial milestones of up to $475 million.

    Darovasertib Combinations in Metastatic Uveal Melanoma (MUM)

    IDEAYA is executing on its strategy to evaluate darovasertib combinations in MUM, including combinations of darovasertib and crizotinib, and independently, darovasertib and binimetinib, in each case under a clinical trial collaboration and supply agreement with Pfizer Inc.

    The company initiated Phase 2 of the clinical trial evaluating darovasertib and crizotinib combination in MUM based on observed early clinical activity of this combination.  In the first cohort of the dose escalation portion of the Phase 1 clinical trial, an earlier-reported unconfirmed partial response of 54.3% tumor reduction has subsequently confirmed with a 56.5% tumor reduction in a subsequent scan, which represents the deepest response observed to date in the Phase 1/2 clinical trial evaluating darovasertib as monotherapy or in combinations.

    Drug-related adverse events observed in the darovasertib and crizotinib combination arm in MUM as of June 22, 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 treated patients of nausea, diarrhea, vomiting, edema, decreased appetite, rash, hypotension and syncope. The observed syncope and hypotension were transient, often occurring in the first week of dosing, and are being managed / mitigated through a one week run-in dosing regimen and by limiting use of certain concurrent medications such as diuretics.

    In the darovasertib and binimetinib combination arm of the Phase 1 clinical trial, an earlier-reported unconfirmed partial response of 40.5% tumor reduction has been confirmed with a 51.7% tumor reduction in a subsequent scan.

    Drug-related adverse events observed in the darovasertib and binimetinib combination arm in MUM, as of June 22, 2021 data cutoff based on preliminary data and analysis from an unlocked database, primarily include: serious adverse events of liver toxicity, nausea and vomiting, syncope and fall; and adverse events that occurred in greater than 10% of patients of nausea, vomiting, diarrhea, rash, edema, fatigue, hypotension and creatine phosphokinase increase.

    As of June 22, 2021, IDEAYA has enrolled 30 MUM patients in the darovasertib and binimetinib combination arm, and 15 MUM patients in the darovasertib and crizotinib combination arm.  IDEAYA is targeting a further clinical data update for darovasertib combination(s) in the second half of 2021.  The company is planning to obtain FDA regulatory guidance on potential registration-enabling trial design for darovasertib monotherapy and/or darovasertib combination(s) in MUM in the second half of 2021 or the first half of 2022, respectively.

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

    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 timing of additional clinical trial sites in the IDE397 Phase 1 dose escalation study, (ii) the obtention of pre-treatment and post-treatment tumor biopsies from patients enrolled into the IDE397 tumor biopsy cohort to evaluate PD response, (iii) exercise of the GSK option, cost sharing, milestone payments, profit share and royalties related to IDE397, and (iv) the timing of a clinical data update for either of the darovasertib combination arms and FDA guidance for potential darovasertib registrational pathway.  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 risk that results of earlier studies and trials may not be predictive of future trial results, the risk that regulatory authorities, including the FDA may not agree with IDEAYA's interpretation of the data from clinical trials of IDEAYA's drug candidates, the risk that that IDEAYA may experience delays in the commencement, enrollment, completion or analysis of clinical testing for its drug candidates, or significant issues regarding the adequacy of IDEAYA's clinical trial designs or the execution of its clinical trials may arise, which could result in increased costs and delays, or limit IDEAYA's ability to obtain regulatory approval, unexpected adverse side effects or inadequate therapeutic efficacy of IDEAYA's drug candidates that could delay or prevent clinical results, regulatory approval or commercialization, 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 the Company's business of the worldwide COVID-19 pandemic and other matters. 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 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-announces-ide397-phase-1-clinical-pharmacodynamic-data-and-phase-2-initiation-of-darovasertib-and-crizotinib-combination-301320737.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  8. SOUTH SAN FRANCISCO, Calif., May 24, 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 at the 2021 Jefferies Virtual Healthcare Conference.

    2021 Jefferies Virtual Healthcare Conference

    Fireside Chat with Maury Raycroft

    Thursday, June 3, 2021 at 1:00 pm ET

    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.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-to-present-at-2021-jefferies-virtual-healthcare-conference-301297342.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  9. SOUTH SAN FRANCISCO, Calif., May 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, announced dose expansion of the ongoing Phase 1/2 study (ClinicalTrials.gov Identifier: NCT03947385) evaluating the combination of darovasertib and crizotinib in metastatic uveal melanoma (MUM).  IDEAYA is the sponsor of this combination study, which is being conducted pursuant to a clinical trial collaboration and supply agreement with Pfizer Inc. Darovasertib is IDEAYA's clinical stage protein kinase C, or PKC, inhibitor and crizotinib is a cMET inhibitor to which Pfizer has exclusive worldwide rights.

    SOUTH SAN FRANCISCO, Calif., May 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, announced dose expansion of the ongoing Phase 1/2 study (ClinicalTrials.gov Identifier: NCT03947385) evaluating the combination of darovasertib and crizotinib in metastatic uveal melanoma (MUM).  IDEAYA is the sponsor of this combination study, which is being conducted pursuant to a clinical trial collaboration and supply agreement with Pfizer Inc. Darovasertib is IDEAYA's clinical stage protein kinase C, or PKC, inhibitor and crizotinib is a cMET inhibitor to which Pfizer has exclusive worldwide rights.

    "We are encouraged to see the early deep partial response in the first cohort of the darovasertib and crizotinib combination. We look forward to the dose expansion phase and to continue dose exploration to clinically validate the preclinical combination hypothesis discovered by IDEAYA," said Dr. Marlana Orloff, M.D., Assistant Professor, Thomas Jefferson University Hospitals.

    IDEAYA presented translational data at AACR 2021 retrospectively evaluating cMET expression in clinical biopsies from MUM patients in a Darovasertib Phase 1 clinical trial, as well as preclinical data evaluating synergy between darovasertib and crizotinib in relevant cell models of a liver tumor microenvironment, a site of approximately 90% of uveal melanoma metastases. "We identified inhibition of the cMET signaling pathway in combination with PKC in the metastatic setting as a potential treatment regimen, and are excited to observe our first signal of clinical activity to validate this research finding," said Mick O'Quigley, Vice President, Head of Development Operations at IDEAYA Biosciences.

    Darovasertib / Crizotinib Combination Therapy

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

    • 6 MUM patients have enrolled in the darovasertib and crizotinib combination study and 2 of these patients were evaluable for response with at least one post-baseline scan  
    • Observed early clinical efficacy of the darovasertib and crizotinib combination in MUM.  As of data and analyses cutoff on May 5, 2021 based on preliminary data from an unlocked database, these data showed:
      • tumor reduction in 2 of 2 evaluable patients in a first cohort
      • one unconfirmed partial response in a 3rd-line patient, with a 54% tumor reduction, which is the deepest response reported in the darovasertib clinical trial to date; this patient is awaiting a confirmatory 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
    • Initiated dose expansion for a cohort of the Phase 1/2 darovasertib / crizotinib combination arm, with additional dose exploration ongoing
    • 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, as 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 co-targeting PKC and cMET signaling

    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 dose expansion in the darovasertib / crizotnib combination arm of the ongoing Phase 1/2 study.  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 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.  

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-announces-dose-expansion-in-phase-12-study-of-darovasertib-and-crizotinib-combination-based-on-early-clinical-efficacy-in-first-combination-cohort-301287055.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  10. SOUTH SAN FRANCISCO, Calif., May 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 first quarter ended March 31, 2021.

    "We are excited to advance IDE397, a potential best-in-class MAT2A inhibitor, in the Phase 1 dose escalation for evaluation in patients with MTAP deletion tumors, including in non-small cell lung cancer (NSCLC).  We are also continuing to invest in our preclinical synthetic lethality programs, including our PARG and Pol Theta programs for patients with HRD tumors, where we are targeting a development candidate for both programs in 2021," said Yujiro S. Hata, Chief Executive Officer and President of IDEAYA Biosciences.

    "We are excited by the preliminary darovasertib monotherapy overall survival data in MUM and look forward to receiving FDA regulatory guidance based on the data in the second half of 2021.  We are also executing on our darovasertib clinical combination strategy and are encouraged by the early partial responses observed in the combination arms, including now in the crizotinib combination. Importantly, the 54% tumor reduction by RECIST 1.1 observed in a patient treated with the darovasertib and crizotinib combination is the deepest partial response we have seen to date in the darovasertib Phase 1/2 clinical trial," said Matthew Maurer, M.D., Vice President, Head of Clinical Oncology and Medical Affairs, 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:

    • Initiated a Phase 1 clinical trial designated as IDE397-001 (ClinicalTrials.gov Identifier: NCT04794699) to evaluate IDE397 under an investigational new drug application
    • Completed enrollment into an initial dose escalation cohort of the Phase 1 clinical trial
    • Clinical development plans for IDE397 include a dose escalation portion of the Phase 1 clinical trial in which IDEAYA is enrolling patients having solid tumors with MTAP gene deletion.  Patients are being identified by next generation sequencing (NGS) or by MTAP immunohistochemistry (IHC) assay with confirmatory NGS
    • 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
    • Planning to obtain patient biopsies from the dose escalation and expansion portions of the clinical trial for translational research, including evaluation of certain pharmacodynamic, or PD, biomarkers, such as peripheral S-adenosyl methionine (SAM), tumor SAM and tumor symmetric dimethylarginine (SDMA)
    • Program objective is to obtain preliminary clinical PD data from the dose-escalation portion of the IDE397 monotherapy Phase 1 clinical trial in the second half of 2021
    • 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 and showed:
      • tumor regressions, with >100% tumor growth inhibition, or TGI, in multiple PDX models across multiple solid tumor types, including in NSCLC as well as in bladder and gastric cancer models
      • >75% TGI in approximately 50% of models and across major solid tumor types
      • >60% TGI in approximately 75% of models and across major solid tumor types
      • dose-dependent modulation of PD biomarkers, including SDMA and SAM
    • Observed single-agent IDE397 preclinical activity in NSCLC PDX models, demonstrating >60% TGI in 11 independent PDX models out of 13 models evaluated in the MTAP-deletion PDX panel study, including in 7 of 9 NSCLC adenocarcinoma PDX models, and in 4 of 4 NSCLC squamous carcinoma PDX models evaluated, and demonstrating tumor regressions in 2 of 4 NSCLC squamous PDX models, including one complete response
    • Showed correlation of in vivo efficacy with PD modulation of tumor SDMA and tumor SAM in a study evaluating IDE397 in an MTAP-deletion NSCLC CDX model
    • Reported preclinical analyses of genomic and metabolic effects of pharmacological inhibition of MAT2A in an isogenic cell pair and of proliferation effects in a panel of MTAP wild type and MTAP-deleted cell lines at AACR 2021
    • Observed in vivo efficacy of IDE397 in combination with a taxane, showing enhanced TGI in a pancreatic cancer PDX model, and separately in combination with a PRMT inhibitor, showing enhanced TGI in an HCT116 MTAP-null CDX model

    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
    • Reported preclinical data at AACR 2021, including pharmacological inhibition of PARG in a panel of homologous recombination deficient cell lines and in CDX and PDX models
    • Subject to further preclinical studies, IDEAYA is targeting to identify a PARG inhibitor development candidate in 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 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 in vivo efficacy and PD response in relevant MSI high 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 a proprietary biomarker or a gene signature.

    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 these combination arms of the Phase 1/2 clinical trial, and it targeting to provide a clinical data update for the darovasertib combination(s) in the second half of 2021. Based on preliminary monotherapy clinical data in MUM and its mechanism of action, we anticipate darovasertib clinical activity independent of Human Leukocyte Antigen (HLA) status in GNAQ/11-mutation cancers.

    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.  IDEAYA is targeting to receive FDA guidance in H2 2021 on potential regulatory path, based on the preliminary darovasertib monotherapy overall survival data in MUM. 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:

    • Reported interim clinical data from Phase 1/2 clinical trial arm evaluating monotherapy darovasertib in predominantly second and third line (2L/3L) and heavily pre-treated out to seventh or eighth line (7L/8L) MUM patients.  As of data and analyses cutoff on April 13, 2021 based on preliminary data from an unlocked database: 
      • Enrolled an aggregate of 81 darovasertib monotherapy BID MUM patients across the IDEAYA and Novartis Phase 1/2 clinical trials, with 81 patients evaluable for safety and 75 patients evaluable for efficacy pursuant to RECIST 1.1 guidelines
      • Observed 57% 1-year overall survival (OS) with 95% confidence interval (44%, 69%), in predominantly 2L/3L and heavily pretreated to 7L/8L patients
      • Observed 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
      • Historical 37% 1-year OS and median OS of ~7 months have been reported in similar 2L/3L+ MUM patient population (Rantala 2019)
      • Observed tumor reduction in 61% (n=46) of 75 evaluable MUM patients pursuant to RECIST 1.1 guidelines, including 15 patients (20%) with >30% target lesion reduction, and one confirmed complete response
    • Reported preliminary clinical data from Phase 1/2 clinical basket trial arm evaluating monotherapy darovasertib in skin melanoma patients. As of data and analyses cutoff of April 13, 2021 based on preliminary data from an unlocked database: 
      • Enrolled 7 darovasertib monotherapy BID skin melanoma patients in the IDEAYA Phase 1/2 clinical trial, with 7 patients evaluable for safety and 5 patients evaluable for efficacy pursuant to RECIST 1.1 guidelines
      • Observed tumor reduction in 80% (n=4) of 5 evaluable skin melanoma patients pursuant to RECIST1.1 guidelines, including one confirmed PR
    • 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:

    • Initiated dose expansion evaluating the darovasertib / binimetinib combination in MUM based on early clinical activity
    • Amended the clinical trial collaboration and supply agreement with Pfizer to support target enrollment of approximately 40 patients in the darovasertib and binimetinib clinical combination arm
    • Reported preliminary clinical data from Phase 1/2 clinical trial arm evaluating the darovasertib / binimetinib combination in MUM patients, predominantly as 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: 
      • 24 MUM patients have enrolled in the darovasertib and binimetinib combination study and 14 of these patients were evaluable, including eight patients dosed in the Phase 1/2 dose expansion cohort of the combination study
      • Observed 22% (n=2) partial responses (PR), including one confirmed PR and on unconfirmed PR awaiting a confirmatory scan, of nine evaluable MUM patients with at least two post-baseline scans pursuant to RECIST 1.1 guidelines
      • Observed tumor reduction in 79% (n=11) of 14 evaluable MUM patients with at least one post-baseline scan pursuant to RECIST1.1 guidelines 
    • 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:

    • 6 MUM patients have enrolled in the darovasertib and crizotinib combination study and 2 of these patients were evaluable for response with one post-baseline scan  
    • Observed early clinical efficacy of the darovasertib and crizotinib combination in MUM.  As of data and analyses cutoff on May 5, 2021 based on preliminary data from an unlocked database, these data showed:
      • tumor reduction in 2 of 2 evaluable patients in a first cohort
      • one unconfirmed partial response in a 3rd-line patient, with a 54% tumor reduction, which is the deepest response, as reflected by the largest percentage reduction in tumor size, reported in the darovasertib clinical trial to date; this patient is awaiting a confirmatory 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.
    • Initiated dose expansion for a cohort of the Phase 1/2 darovasertib / crizotinib combination arm, with additional dose exploration ongoing  
    • 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, as 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

    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 $9.0 million and $5.1 million for the three months ended March 31, 2021 and December 31, 2020, respectively. As of March 31, 2021, the company had an accumulated deficit of $136.0 million.

    As of March 31, 2021, IDEAYA had cash, cash equivalents and marketable securities of $310.4 million. IDEAYA supplemented its first-quarter-end cash, cash equivalents and marketable securities with an additional $14.6 million in aggregate gross proceeds received subsequent to quarter end from the sale and issuance of common stock at a weighted average sale price of $22.99 per share under an at-the-market offering pursuant to the January 2021 Sales Agreement with Jefferies as sales agent.

    IDEAYA believes that its cash, cash equivalents and marketable securities will be sufficient to fund our planned operations into 2024. 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 March 31, 2021, IDEAYA had cash, cash equivalents and short-term marketable securities totaling $310.4 million. This compared to cash, cash equivalents and short-term and long-term marketable securities of $283.6 million at December 31, 2020. The increase was primarily due to $41.8 million in net proceeds received through March 31, 2021 from issuance of common stock under at-the-market offerings pursuant to the August 2020 Sales Agreement and 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 March 31, 2021 totaled $7.2 million compared to $10.6M for the three months ended December 31, 2020. Collaboration revenue was recognized for the performance obligations satisfied through March 31, 2021 under the GSK Collaboration Agreement.

    Research and development (R&D) expenses for the three months ended March 31, 2021 totaled $11.6 million compared to $12.1 million for the three months ended December 31, 2020. The decrease was primarily due to a decrease in external clinical development expenses for IDE397 and darovasertib and a decrease in fees to CROs, CMOs and external consultants related to our lead product candidates, offset by an increase in R&D headcount costs.

    General and administrative (G&A) expenses for the three months ended March 31, 2021 totaled $4.8 million compared to $3.8 million for the three months ended December 31, 2020. The increase was primarily due to an increase in G&A headcount costs, an increase in legal patent expense, and an increase in costs related to the filing of our shelf registration statement on Form S-3 during the quarter.

    The net loss for the three months ended March 31, 2021 was $9.0 million compared to $5.1 million for the three months ended December 31, 2020. Total stock compensation expense for the three months ended March 31, 2021 was $1.9 million compared to $1.0 million for the three months ended December 31, 2020.

    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 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 obtaining FDA guidance for potential darovasertib registrational pathway, (ii) the enrollment into expansion arms of the IDE397 clinical trial, (iii) the timing of obtaining preliminary clinical PD data from the dose-escalation portion of the IDE397 monotherapy Phase 1 clinical trial (iv) the timing of identification of a development candidate for a PARG in inhibitor, (v) the timing of identification of a development candidate for a Pol Theta inhibitor, (vi) darovasertib clinical activity independent of HLA status, (vii) the impact of COVID-19, and (viii) 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 May 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







    March 31, 2021





    December 31, 2020



    Collaboration revenue



    $

    7,247





    $

    10,571



    Operating expenses

















         Research and development





    11,566







    12,051



         General and administrative





    4,816







    3,800



              Total operating expenses





    16,382







    15,851



    Loss from operations





    (9,135)







    (5,280)



         Interest income and other income (expense), net





    114







    145



    Net loss



    $

    (9,021)





    $

    (5,135)



         Change in unrealized gains (losses) on

             marketable securities





    (7)







    (28)



    Comprehensive loss



    $

    (9,028)





    $

    (5,163)



    Net loss per share attributable to common stockholders,

        basic and diluted



    $

    (0.28)





    $

    (0.18)



    Weighted average number of shares outstanding,

        basic and diluted





    31,761,207







    29,149,106



     

     

    IDEAYA Biosciences, Inc.

    Condensed Balance Sheet Data

    (in thousands)









    March 31,





    December 31,







    2021





    2020



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

       marketable securities



    $

    310,401





    $

    283,585



    Total assets





    326,097







    298,269



    Total liabilities





    92,971







    99,995



    Total liabilities and stockholders' equity





    326,097







    298,269



     

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-inc-reports-first-quarter-2021-financial-results-and-provides-business-update-301287056.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  11. SOUTH SAN FRANCISCO, Calif., May 6, 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 at the following upcoming investor relations event.

    Investor Relations Event

    • 2021 JP Morgan Conference Call Series

      Fireside Chat with Analyst Anupam Rama

      Monday, May 10, 2021 at 11:00 am ET

    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/news-events/investor-calendar.  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 recent Annual Report on Form 10-K filed on March 23, 2021 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-to-participate-in-upcoming-may-2021-investor-relations-event-301285326.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  12. SOUTH SAN FRANCISCO, Calif., April 19, 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 the agenda for its inaugural Synthetic Lethality Investor Day. The event will be held virtually on Tuesday, April 20, 2021, at 1:00 pm - 3:00 pm ET (10:00 am - 12:00 noon PT). The agenda will include scientific presentations from IDEAYA, GlaxoSmithKline (GSK) and several key opinion leaders.

    Presenters

    • Alan D'Andrea, M.D., Director, Center of DNA Damage and Repair, Dana Farber Cancer Institute of Harvard Medical School
    • William Sellers, M.D., Core Institute Member and Director of the Cancer Program of the Broad Institute of MIT and Harvard
    • Benjamin Schwartz, Ph.D., Vice President, Head of Oncology Synthetic Lethality Research Unit, GlaxoSmithKline (GSK)
    • Yujiro Hata, President and Chief Executive Officer, IDEAYA Biosciences
    • Michael Dillon, Ph.D., SVP and Chief Scientific Officer, IDEAYA Biosciences
    • Mark Lackner, Ph.D., SVP and Head of Biology and Translational Sciences, IDEAYA Biosciences
    • Matt Maurer, M.D., VP and Head of Clinical Oncology and Medical Affairs, IDEAYA Biosciences

    Program Agenda (ET)

    • 1:00 pm - Welcome and Introduction
      • Yujiro Hata
    • 1:10 pm - Synthetic Lethality: Emerging Area within Precision Medicine and GSK-IDEAYA Partnership
      • Ben Schwartz (GSK)
    • 1:20 pm - IDE397: Targeting MAT2A in MTAP-Deleted Tumors
      • Bill Sellers (Broad), Mark Lackner, Matt Maurer
    • 1:50 pm - Werner Helicase (Roundtable): Compelling Synthetic Lethality Target
      • Introduction: Ben Schwartz (GSK)
      • Panelists:Bill Sellers (Broad), Mike Dillon, Ben Schwartz
      • Moderator: Yujiro Hata
    • 2:10 pm - Pol Theta: Key Target in MMEJ DNA Damage Repair Pathway
      • Alan D'Andrea (Harvard), Mike Dillon, Ben Schwartz (GSK)
    • 2:30 pm - PARG: Novel Target in Clinically Validated Pathway
      • Mike Dillon, Mark Lackner
    • 2:45 pm - Analyst Q&A / Closing
      • Yujiro Hata
    • 3:00 pm - Adjourn

    Registration for the IDEAYA Synthetic Lethality Investor Day and additional information on the event is available on IDEAYA's website at https://ir.ideayabio.com/events.

    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 the timing, content and participants of the Synthetic Lethality Investor Day. 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 the IDEAYA Annual Report for the year ended December 31, 2020 on Form 10-K filed on March 23, 2021 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.   

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-announces-agenda-for-inaugural-synthetic-lethality-investor-day-on-tuesday-april-20-2021-301271007.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  13. SOUTH SAN FRANCISCO, Calif., April 16, 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 clinical data from the ongoing Phase 1/2 trial evaluating darovasertib (IDE196) monotherapy and binimetinib combination therapy in patients with solid tumors, including Metastatic Uveal Melanoma (MUM) and Skin Melanoma (ClinicalTrials.gov Identifier: NCT03947385).

    "The darovasertib single-agent one-year survival data in MUM is encouraging and compares favorably to historical survival rates in this indication, where a therapy has yet to be approved," said Meredith McKean, MD, MPH, Associate Director, Melanoma and Skin Cancer Research,  Sarah Cannon Research Institute at Tennessee Oncology, Nashville, TN. "The early partial responses observed in the darovasertib and binimetinib combination in MUM are exciting where historical response rates have been from zero to low to mid-single-digit percent, and we look forward to seeing the data set mature," said Richard Carvajal, MD, Co-Leader, Precision Oncology and Systems Biology Program, Director of Experimental Therapeutics and Director of the Melanoma Service, Columbia University Irving Medical Center.

    Darovasertib Monotherapy Clinical Efficacy in Solid Tumors

    There have been 81 darovasertib monotherapy BID MUM and 7 Skin Melanoma patients enrolled across the IDEAYA and Novartis Phase 1/2 clinical trials at the time of data and analyses cutoff on April 13th, 2021, with an aggregate of 88 patients evaluable for safety and 81 evaluable for efficacy based on RECIST 1.1.  Reported data is preliminary and based on an unlocked database.  Evaluation and follow-up of the monotherapy arm of the clinical trial continues. 

    Darovasertib Monotherapy Preliminary Results Summary

    • 57% 1-Year Overall Survival (OS) Rate was observed in predominantly second line, third line and heavily pre-treated (out to 7 and 8 lines of prior treatment) Metastatic Uveal Melanoma (MUM) patients with 95% CI (44%, 69%); Historical 1-Year OS Rate in similar MUM populations has been reported at 37% (Source: Rantala 2019, Immunocore March 2021 presentation, Synthetic Control Arm, 2+ L)
    • Median OS of 13.2 months was observed in predominanantly second line, third line and heavily pre-treated (out to 7 and 8 lines of prior treatment) MUM patients with 95% CI (10.7 months, Not Reached); Historical median OS in similar MUM populations has been reported at approximately 7 months (Source: Rantala 2019, Immunocore March 2021, Synthetic Control Arm, 2+ L)
    • 61% (n=46) of MUM patients out of 75 evaluable had tumor reduction per RECIST 1.1. evaluation, including 15 patients (20%) with >30% target lesion reduction and one confirmed complete response. In the Skin Melanoma cohort, 80% (n=4) of evaluable patients (n=5) had tumor reduction per RECIST 1.1. evaluation, including one confirmed partial response

    Darovasertib Monotherapy Clinical Safety

    Overall safety profile of darovasertib monotherapy is consistent with prior reports (Ref. 2019 AACR) and includes primarily common low grade but manageable GI toxicities and hypotension.

    Preliminary Darovasertib and Binimetinib Combination Clinical Efficacy in MUM

    The combination of darovasertib plus binimetinib is being evaluated pursuant to a clinical trial collaboration and drug supply agreement with Pfizer, which the companies have amended to support a target enrollment of approximately 40 patients in the darovasertib and binimetinib clinical combination arm in MUM.  At the time of the data and analyses cutoff on April 13th, 2021, twenty four MUM patients have enrolled in the darovasertib and binimetinib combination study, including 8 patients dosed in the Phase 1/2 dose expansion cohort of the combination study.  Reported data is preliminary and based on an unlocked database.  Enrollment in the darovasertib and binimetinib combination arm of the clinical trial is ongoing. 

    Darovasertib and Binimetinib Combination Therapy Preliminary Data Summary

    • 2 partial responses observed out of nine MUM patients with at least 2 post-baseline scans (22%) by RECIST 1.1 guidelines, including 1 confirmed partial response and 1 unconfirmed partial response (-40.5%) awaiting a confirmatory scan
    • 79% of evaluable MUM patients with at least 1 post-baseline scan show tumor reduction; follow-up for overall response is still immature
    • Combination doses for Phase 1/2 dose expansion have been selected based on anticipation of activity and overall tolerability in a larger treatment cohort
    • Treatment-related adverse events observed in the darovasertib and binimetinib combination arm in MUM primarily include: nausea, vomiting, diarrhea, rash, edema, AST/ALT increase and CK increase (>10%); and hypotension (<10%)

    IDEAYA's clinical development strategy in MUM is focused on darovasertib combinations, including with binimetinib, a MEK inhibitor, and in a separate clinical study with crizotinib, a cMET inhibitor, each pursuant to the  clinical trial collaboration and drug supply agreement with Pfizer.

    Darovasertib Investor Day Webcast

    IDEAYA will host an investor webcast with a  presentation at 8:00 a.m. ET today. A link to the webcast and a copy of the presentation is posted on the Investor Relations Events section of the Company's website at  https://ir.ideayabio.com/events.  The update may also be accessed by dialing 1-866-248-8441 (domestic) or 1-720-452-9102 (international) five minutes prior to the start of the call and providing the passcode 2793795. An archived replay of the webcast will be accessible for 90 days following the event.

    Meredith McKean, MD, MPH, Associate Director, Melanoma and Skin Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, Nashville, TN, and Richard Carvajal, MD, Co-Leader, Precision Oncology and Systems Biology Program, Director of Experimental Therapeutics and Director of the Melanoma Service, Columbia University Irving Medical Center, will participate in the webcast.

    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 the darovasertib (IDE196) clinical development strategy.  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 Annual Report on Form 10-Kfiled on March 23, 2021and any current and periodic reports filed with the U.S. Securities and Exchange Commission.  

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-reports-darovasertib-ide196-monotherapy-overall-survival-data-and-observes-early-partial-responses-in-binimetinib-combination-in-metastatic-uveal-melanoma-301270346.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  14. SOUTH SAN FRANCISCO, Calif., April 15, 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 the company plans to issue a pre-market press release and conduct a webcast on Friday, April 16, 2021, to discuss clinical data from the ongoing Phase 1/2 trial evaluating darovasertib (IDE196) as monotherapy and darovasertib and binimetinib combination in patients with metastatic uveal melanoma (MUM) (ClinicalTrials.gov Identifier: NCT03947385).

    IDEAYA will host a Darovasertib Investor Day, including a conference call and webcast with participation of leading clinical investigators, at 8:00 a.m. ET on Friday, April 16, 2021.  The link to the webcast of the conference call will be posted on the Investor Relations Events section of the Company's website at: https://ir.ideayabio.com/events.  The update may also be accessed by dialing 1-866-248-8441 (domestic) or 1-720-452-9102 (international) five minutes prior to the start of the call and providing the passcode 2793795. An archived replay will be accessible for 90 days following the event.

    IDEAYA also announced the International Nonproprietary Name (INN) for IDE196 is "darovasertib" as registered with the World Health Organization (WHO)'s Programme and Classification of Medical Products.

    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 the Darovasertib (IDE196) Investor Day.  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 Annual Report on Form 10-K filed on March 23, 2021 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.  

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-announces-investor-day-webcast-to-review-clinical-data-from-phase-12-trial-of-darovasertib-ide196-monotherapy-and-combination-with-binimetinib-in-metastatic-uveal-melanoma-301270102.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  15. SOUTH SAN FRANCISCO, Calif., April 15, 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 First-Patient-In (FPI) in the Phase 1 clinical trial evaluating IDE397 (ClinicalTrials.gov Identifier: NCT04794699).  IDE397 is a potential best-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor being evaluated in cancer patients harboring methylthioadenosine phosphorylase (MTAP) deletion. 

    "We are excited to dose the first patient in the evaluation of IDE397 targeting MAT2A in MTAP deletion patients.  IDE397 has the potential to be broadly impactful for cancer patients with MTAP deletion, which is prevalent in approximately 15% of solid tumors," said Anthony Tolcher, M.D., Director of Clinical Research, Founder and CEO at NEXT Oncology.

    IDE397 is an internally discovered potential best-in-class MAT2A inhibitor that received IND-clearance from the U.S. FDA to initiate Phase 1 in Q1 2021.  As reported at AACR 2021, IDE397 demonstrated significant single-agent anti-tumor activity in a 40-plus MTAP-deletion study, including tumor regressions, across major solid tumor types, such as NSCLC, gastric, esophageal, bladder, among others.  In addition to IDE397 monotherapy, IDEAYA is evaluating multiple potential combinations preclinically, including in the PRMT pathway and with taxanes, among others. Multiple clinical trial sites are being activated across the U.S. to evaluate IDE397 clinically, and MTAP-deletion patients will be identified for study enrollment through commercially available Next Generation Sequencing (NGS) platforms and with an MTAP-IHC assay which IDEAYA has developed in collaboration with Ventana.

    "We believe that IDE397 is a differentiated small molecule MAT2A inhibitor, with the potential for monotherapy clinical development in genetically defined MTAP deleted cancers," said Matthew Maurer, M.D., Vice President, Head of Clinical Oncology and Medical Affairs at IDEAYA Biosciences.  "Dosing our first patient for IDE397 in our Phase 1 MTAP-deletion solid tumor trial is a substantial company milestone. IDEAYA is targeting to advance our next two Synthetic Lethality programs in PARG and Pol Theta to development candidate stage in 2021 and advancing our internal pipeline in the MTAP-deletion synthetic lethality space to complement our Phase 1 MAT2A inhibitor IDE397," said Yujiro S. Hata, President and Chief Executive Officer, 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 activation of clinical trial sites, (ii) the utilization of NGS platforms and MTAP-IHC assay, (iii) the timing and content of IDE397 program update, (iv) the best-in class potential of IDE397, (v) the potential impact and single agent activity IDE397 and (vi) the timing for development candidate identification for PARG and Pol Theta programs.  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 Annual Report on Form 10-K filed on March 23, 2021 and any current and periodic reports filed with the U.S. Securities and Exchange Commission. 

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-announces-dosing-of-first-patient-of-mat2a-inhibitor-ide397-in-phase-1-clinical-trial-evaluating-mtap-deletion-solid-tumors-301269368.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  16. SOUTH SAN FRANCISCO, Calif., March 23, 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 fourth quarter ended December 31, 2020.

    "In the last quarter, we have made important progress towards our goal to build a preeminent synthetic lethality-focused precision medicine oncology company, including advancing IDE397 into Phase 1 as a potential best-in-class MAT2A inhibitor to treat patients with MTAP-deletion, which represents approximately 15% of all solid tumors. We are also poised to expand our synthetic lethality pipeline, targeting Development Candidate nominations in 2021 for each of our potential first-in-class PARG and Pol Theta programs. Lastly, IDE196 has reached a key inflection point as we initiated dose expansion in our Phase 1/2 study evaluating the IDE196 / binimetinib combination in the GNAQ/11 mutation-driven cancer of metastatic uveal melanoma," 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 developing IDE397, a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A), for solid tumors with methylthioadenosine phosphorylase (MTAP) deletions, a patient population estimated to represent approximately 15% of solid tumors.   IDEAYA continues to lead research and development on the MAT2A program through early clinical development.  Subject to exercise of its option, GSK will lead later stage global clinical development.  Highlights:

    • IDE397 investigational new drug application (IND) is effective for Phase 1 clinical trial evaluation of IDE397; targeting monotherapy First-Patient-In in first quarter of 2021;
    • Clinical development plans for IDE397 include a dose escalation portion of the Phase 1 clinical trial in which IDEAYA plans to enroll patients having solid tumors with MTAP gene deletion. Patients will be identified by next generation sequencing (NGS) or by MTAP immunohistochemistry (IHC) assay with confirmatory NGS;
    • Subject to satisfactory completion of the dose escalation portion of the Phase 1 clinical trial, IDEAYA plans to enroll MTAP deletion patients into one or more expansion arms in solid tumor indications selected based on preclinical data from a 40+ model PDX study and well as clinical development and commercial considerations;
    • Planning to obtain patient biopsies from the dose escalation and expansion portions of the clinical trial for translational research, including evaluation of certain pharmacodynamic, or PD, biomarkers, such as peripheral S-adenosyl methionine (SAM), tumor SAM and tumor symmetric dimethylarginine (SDMA);
    • Program objective to obtain preliminary clinical PD data from the dose-escalation portion of the IDE397 monotherapy Phase 1 clinical trial in the second half of 2021;
    • Evaluating the preclinical efficacy of monotherapy IDE397 in over forty solid tumor patient derived xenograft (PDX) models with homozygous MTAP deletions across a range of solid tumor types. Preliminary results of this study show in vivo efficacy in multiple MTAP-null xenograft models when MAT2A is pharmacologically inhibited with IDE397 as monotherapy: we observed (a) tumor regressions, with >100% tumor growth inhibition, or TGI, in multiple PDX models across multiple solid tumor types, and (b) >75% TGI in approximately 50% of models and across major solid tumor types;
    • Planning to present data summarizing the results of the IDE397 MTAP-deletion preclinical PDX panel study at the 2021 Annual Meeting of the American Association for Cancer Research (AACR) in April 2021;
    • Planning to present preclinical data at AACR in April 2021 evaluating the effects of pharmacological inhibition of MAT2A, including analyses of genomic and metabolic effects in an isogenic cell pair and of proliferation effects in a panel of MTAP wild type and MTAP-deleted cell lines; and
    • Preclinical combination tolerability and efficacy studies are ongoing to evaluate IDE397 in combination with GSK oncology assets as well as other potential oncology agents, such as taxanes, in preclinical studies.

    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.   Highlights:

    • Demonstrated dose-dependent in vivo efficacy as monotherapy with tumor regression or stasis in multiple PDX models and in multiple cell-derived xenograft, or CDX, models. Observed tumor regressions (> 100% TGI) in multiple breast cancer PDX models with defined genetic and subtyping profiles. Observed tumor regressions and enhanced TGI relative to niraparib in multiple CDX models, including in vivo efficacy in a niraparib-resistant resistant CDX model;
    • Planning to present data at AACR in April 2021 summarizing the results of preclinical studies evaluating the effects of pharmacological inhibition of PARG in a panel of homologous recombination deficient cell lines, and in CDX and PDX models; and
    • Subject to further preclinical studies, IDEAYA is targeting to identify a PARG inhibitor development candidate in 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 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.  

    DNA Damage Targets

    IDEAYA has initiated multiple preclinical synthetic lethality research programs, designated as DDT1 and DDT2, to identify small molecule inhibitors for DNA Damage Targets (DDT's) for patients with solid tumors characterized by a proprietary biomarker or gene signature. 

    IDEAYA Synthetic Lethality Investor Day

    IDEAYA is hosting an inaugural IDEAYA Synthetic Lethality Investor Day on April 20, 2020 at 1:00-3:00 pm ET with presentations from IDEAYA and GSK scientists, as well as renowned key opinion leaders. This event will be held in a virtual format; for additional information and registration see IDEAYA's website at: https://ir.ideayabio.com/events. Highlights:

    • Scientific presenters include scientists from IDEAYA and GSK, and key opinion leaders Alan D'Andrea (Dana Farber Cancer Institute of Harvard Medical School) and Bill Sellers (Broad Institute of MIT and Harvard); and
    • Topics will include an overview of Synthetic Lethality – an emerging area of precision medicine oncology, the GSK-IDEAYA strategic partnership, and IDEAYA's pipeline programs, including IDE397 clinical-stage program targeting MAT2A in MTAP-deleted tumors, Werner Helicase, a biologically-compelling synthetic lethality target, Pol Theta, a key target in MMEJ DNA Damage Repair pathway, and PARG, a novel target in a clinically validated pathway.

    IDE196 (PKC)

    IDEAYA continues to execute on its clinical trial strategy to evaluate IDE196 combination therapies in Metastatic Uveal Melanoma (MUM), including IDE196 / binimetinib and independently, IDE196 / crizotinib.  The company is also evaluating IDE196 as monotherapy, with a focus in GNAQ/11-mutation skin melanoma.  Based on preliminary IDE196 monotherapy clinical data and its mechanism of action, we anticipate IDE196 clinical activity independent of Human Leukocyte Antigen (HLA) status in GNAQ/11-mutation cancers. 

    IDE196 / Binimetinib Combination Therapy

    IDEAYA is continuing patient enrollment into the IDE196 / binimetinib combination arm under the clinical trial collaboration and supply agreement with Pfizer.  Highlights:

    • Initiated dose expansion in the Phase 1/2 study evaluating the IDE196 / binimetinib combination in MUM based on early clinical activity, including percentage of patients with tumor reduction; targeting to enroll a total of approximately 40 patients in the IDE196 / binimetinib combination arm in MUM; and
    • IDEAYA is anticipating interim data from the IDE196 / binimetinib combination therapy Phase 1/2 portion of the clinical trial in MUM patients in 2021, including tolerability and clinical efficacy.

    IDE196 / Crizotinib Combination Therapy

    IDEAYA is continuing patient enrollment into the IDE196 / crizotinib combination arm under the clinical trial collaboration and supply agreement with Pfizer.   Highlights:

    • Identified cMET as a potential biomarker and a cMET inhibitor as potential combination agent though translational research studies, including a retrospective analysis of human clinical samples from an IDE196 Phase 1 clinical trial, which supported cMET expression / activation as a potential biomarker / combination agent, and preclinical synergies between IDE196 and crizotinib in relevant cell models of a liver tumor; and microenvironment, a site of approximately 90% of uveal melanoma metastases; and
    • Planning to present data summarizing the results of IDE196 cMET translational studies at AACR in April 2021.

    IDE196 Monotherapy

    IDEAYA is continuing enrollment into its ongoing Phase 1/2 basket trial evaluating IDE196 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:

    • Preliminary clinical data from IDE196 monotherapy arm shows that IDE196 activity is independent of HLA status; and
    • IDEAYA anticipates disclosing interim data from the monotherapy arm of its ongoing Phase 1/2 basket trial in 2021, including in MUM and in GNAQ/11-mutation skin melanoma, including tolerability, clinical efficacy, and survival data.

    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 IDE196; the specific impacts are currently uncertain.

    IDEAYA continues to enhance its leadership team with the addition of Matthew Maurer, M.D. as Vice President, Head of Clinical Oncology and Medical Affairs in January 2021.  Dr. Maurer was previously with Bristol Myers Squibb, and was earlier an oncologist and Assistant Professor of Medicine at Columbia University College of Physicians and Surgeons.

    Corporate Updates

    IDEAYA's net losses were $34.5 million and $42.0 million for the years ended December 31, 2020 and December 31, 2019, respectively. As of December 31, 2020, the company had an accumulated deficit of $127.0 million.

    As of December 31, 2020, IDEAYA had cash, cash equivalents and marketable securities of $283.6 million. IDEAYA supplemented its year-end cash, cash equivalents and marketable securities with an additional $43.3 million in aggregate gross proceeds received subsequent to year end from the sale and issuance of common stock under an at-the-market offering pursuant to the August 2020 Sales Agreement or the January 2021 Sales Agreement with Jefferies as sales agent (ATM Program).

    IDEAYA believes that its cash, cash equivalents and marketable securities will be sufficient to fund our planned operations into 2024. 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 December 31, 2020, IDEAYA had cash, cash equivalents and short-term marketable securities totaling $283.6 million. This compared to cash, cash equivalents and short-term and long-term marketable securities of $100.5 million at December 31, 2019. The increase was primarily due to $100.7 million in net proceeds from IDEAYA's follow-on public offering, $100.0 million from the upfront payment received from GSK, $20.0 million in net proceeds from the private placement with GSK, and $6.6 million in net proceeds under the ATM Program received through December 31, 2020.

    Collaboration revenue for the three months ended December 31, 2020 totaled $10.6 million compared to zero for the same period in 2019. Collaboration revenue was recognized for the performance obligations satisfied through December 31, 2020 under the GSK Collaboration Agreement.

    Research and development (R&D) expenses for the three months ended December 31, 2020 totaled $12.1 million compared to $8.5 million for the same period in 2019. The increase was primarily due to manufacturing and clinical startup costs for IDE397, an increase related to our Phase 1/2 clinical trial to evaluate IDE196 in solid tumors, an increase in fees to CROs, CMOs and external consultants related to the advancement of our lead product candidates through preclinical studies and increase in R&D headcount costs.

    General and administrative (G&A) expenses for the three months ended December 31, 2020 totaled $3.8 million compared to $2.8 million for the same period in 2019. The increase was primarily due to an increase in G&A headcount costs, an increase in legal patent expense, and an increase in directors' and officers' liability insurance premiums.

    The net loss for the three months ended December 31, 2020 was $5.1 million compared to $10.8 million for the same period in 2019. Total stock compensation expense for the three months ended December 31, 2020 was $1.0 million compared to $0.7 million for the same period in 2019.

    The net loss for the year ended December 31, 2020 was $34.5 million compared to $42.0 million for the same period in 2019. Total stock compensation expense for the year ended December 31, 2020 was $3.6 million compared to $2.2 million for the same period in 2019.

    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 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 First-Patient-In and other development plans and timing for the Phase 1 clinical trial for IDE397, (ii) the various presentations at the 2021 Annual Meeting of AACR, (iii) the timing of identification of a development candidate for a PARG in inhibitor, (iv) the timing of identification of a development candidate for a Pol Theta inhibitor, (v) the timing and content of release of interim data for the IDE196/binimetinib combination arm of the Phase 1/2 GNAQ/11 basket trial, (vi) the timing and content of release of interim data for the IDE196 monotherapy arm of the Phase 1/2 GNAQ/11 basket trial, (vii) the impact of Copvid-19, and (viii) 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 Annual Report on Form 10-K filed on March 23, 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

    December 31,





    Year Ended

    December 31,





    2020





    2019





    2020





    2019



    Collaboration revenue

    $

    10,571





    $





    $

    19,538





    $



    Total revenue



    10,571













    19,538









    Operating expenses































    Research and development



    12,051







    8,541







    39,698







    34,319



    General and administrative



    3,800







    2,778







    15,184







    9,952



    Total operating expenses



    15,851







    11,319







    54,882







    44,271



    Loss from operations



    (5,280)







    (11,319)







    (35,344)







    (44,271)



    Interest income and other income (expense), net



    145







    538







    849







    2,296



    Net loss

    $

    (5,135)





    $

    (10,781)





    $

    (34,495)





    $

    (41,975)



    Change in unrealized gains (losses) on marketable securities



    (28)







    (13)







    (58)







    96



    Comprehensive loss

    $

    (5,163)





    $

    (10,794)





    $

    (34,553)





    $

    (41,879)



    Net loss per share attributable to common stockholders, basic and diluted

    $

    (0.18)





    $

    (0.53)





    $

    (1.40)





    $

    (3.36)



    Weighted average number of shares outstanding, basic and diluted



    29,149,106







    20,216,275







    24,721,775







    12,496,957



     

    IDEAYA Biosciences, Inc.

    Condensed Balance Sheet Data

    (in thousands)







    December 31,





    December 31,







    2020





    2019



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



    $

    283,585





    $

    100,482



    Total assets





    298,269







    113,001



    Total liabilities





    99,995







    12,601



    Total liabilities and stockholders' equity





    298,269







    113,001



     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-inc-reports-fourth-quarter-2020-financial-results-and-provides-business-update-301253393.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  17. SOUTH SAN FRANCISCO, Calif., March 23, 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 dose expansion of the ongoing Phase 1/2 study (ClinicalTrials.gov Identifier: NCT03947385) evaluating the combination of IDE196 and binimetinib in metastatic uveal melanoma (MUM).  IDEAYA is the sponsor of this combination study, which is being conducted pursuant to a clinical trial collaboration and drug supply agreement with Pfizer. IDE196 is IDEAYA's clinical stage protein kinase C, or PKC, inhibitor and binimetinib is a MEK inhibitor to which Pfizer has exclusive rights in the U.S. and Canada.

    SOUTH SAN FRANCISCO, Calif., March 23, 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 dose expansion of the ongoing Phase 1/2 study (ClinicalTrials.gov Identifier: NCT03947385) evaluating the combination of IDE196 and binimetinib in metastatic uveal melanoma (MUM).  IDEAYA is the sponsor of this combination study, which is being conducted pursuant to a clinical trial collaboration and drug supply agreement with Pfizer. IDE196 is IDEAYA's clinical stage protein kinase C, or PKC, inhibitor and binimetinib is a MEK inhibitor to which Pfizer has exclusive rights in the U.S. and Canada.

    "Metastatic Uveal Melanoma is a high unmet medical need with no FDA approved therapies, and we are encouraged by the early clinical activity observed from the IDE196 and binimetinib combination," said Dr. Richard Carjaval, M.D., Director of Experimental Therapeutics and Director of the Melanoma Service, Columbia University Medical Center. "The Phase 1/2 dose expansion of the IDE196 and binimetinib combination study and the notice of allowance for the U.S. patent application directed to IDE196 and MEK combination therapy are important company milestones, and we look forward to further evaluating the clinical potential of this combination," said Yujiro S. Hata, Chief Executive Officer and President, IDEAYA Biosciences.

    The IDE196 and binimetinib combination initiated dose expansion based on early clinical activity, including percentage of patients with tumor reduction.  The IDE196 and binimetinib combination arm will target to enroll approximately 40 patients in the Phase 1/2 study in MUM.  IDEAYA received a Notice of Allowance of U.S. Patent Application No. 16/666,108 covering methods of treating certain cancer types, including metastatic uveal melanoma, uveal melanoma and melanoma using a combination of IDE196 and a MEK inhibitor.  Based on the preliminary IDE196 monotherapy clinical data and its mechanism of action, IDEAYA anticipates clinical activity independent of Human Leukocyte Antigen (HLA) status in GNAQ/11-mutation cancers.

    IDEAYA is targeting interim data from the IDE196 and binimetinib clinical combination arm in MUM and from the IDE196 monotherapy arm of the Phase 1/2 basket trial in MUM and GNAQ/11-mutation skin melanoma in 2021. As part of the IDE196 monotherapy clinical data update in 2021, IDEAYA is targeting to report tolerability and clinical efficacy, including survival data in MUM.

    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) targeted enrollment in the combination study, (ii) IDE196 activity with respect to HLA status, (iii) the timing and content of release of interim data for the IDE196/binimetinib combination arm of the clinical trial, and (iv) the timing and content of release of interim data for the IDE196 monotherapy arm of the Phase 1/2 GNAQ/11 basket trial.  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 Annual Report on Form 10-K filed on March 23, 2021 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.  

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-announces-dose-expansion-in-phase-12-study-of-ide196-and-binimetinib-combination-in-metastatic-uveal-melanoma-based-on-early-clinical-activity-301253392.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  18. SOUTH SAN FRANCISCO, Calif., March 11, 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 publication of abstracts at the 2021 Annual Meeting of the American Association for Cancer Research (AACR).  IDEAYA will present data for its potential first-in-class synthetic lethality programs IDE397, a Phase 1 methionine adenosyltransferase 2a (MAT2A) inhibitor, poly (ADP-ribose) glycohydrolase (PARG) for which a development candidate is targeted in 2021, and IDE196, a Phase 1/2 protein kinase C (PKC) inhibitor targeting GNAQ/11-mutation cancers.

    SOUTH SAN FRANCISCO, Calif., March 11, 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 publication of abstracts at the 2021 Annual Meeting of the American Association for Cancer Research (AACR).  IDEAYA will present data for its potential first-in-class synthetic lethality programs IDE397, a Phase 1 methionine adenosyltransferase 2a (MAT2A) inhibitor, poly (ADP-ribose) glycohydrolase (PARG) for which a development candidate is targeted in 2021, and IDE196, a Phase 1/2 protein kinase C (PKC) inhibitor targeting GNAQ/11-mutation cancers.

    The IDEAYA abstracts were posted online by AACR (http://www.aacr.org) in advance of the 2021 Annual Meeting of AACR, which will be held April 10-15, 2021:

    • "MAT2A inhibitor, IDE397, displays broad anti-tumor activity across a panel of MTAP-deleted patient-derived xenografts" (Marcus Fischer et al.)
    • "Genomic and metabolomic analysis of MAT2A inhibition reveals increased RNA splicing, lipid metabolism and cell cycle arrest in MTAP deleted tumor models" (Neil Bhola et al.)
    • "Synthetic lethality of PARG inhibition in tumors with homologous recombination deficiencies" (Monah Abed et al.)
    • "Preclinical evaluation of a PKC and MET inhibitor combination in metastatic uveal melanoma" (Marie-Claire Wagle et al.)

    IDEAYA is evaluating IDE397, a potential first-in-class small molecule inhibitor targeting MAT2A, in a Phase 1 clinical trial for patients having tumors harboring MTAP deletion.  IDEAYA plans to present preclinical data evaluating the efficacy of monotherapy IDE397 in over forty patient-derived xenograft (PDX) models with homozygous MTAP deletions across a range of solid tumor types.  IDEAYA will also present preclinical data evaluating the genomic and metabolic effects of pharmacological inhibition of MAT2A in an isogenic cell pair and of proliferation effects in MTAP deleted and MTAP wild type cell lines. 

    IDEAYA is advancing its wholly-owned PARG synthetic lethality program for patients having tumors with a defined biomarker based on genetic mutations and/or molecular signatures.   IDEAYA plans to present preclinical data evaluating the effects of pharmacological inhibition of PARG in a panel of HR-deficient cell lines and cell line derived xenografts (CDX). 

    "We have established a broad and potential first-in-class clinical stage pipeline in synthetic lethality – an emerging area of precision medicine oncology, and are excited to present our program data at AACR 2021," said Dr. Michael Dillon, Ph.D., Senior Vice President, Chief Scientific Officer and Head of Research at IDEAYA Biosciences.

    IDEAYA is evaluating IDE196, a potential first-in-class PKC inhibitor, in a Phase 1/2 clinical trial for the treatment of metastatic uveal melanoma (MUM) and GNAQ/11-mutation skin melanoma. In MUM, the IDE196 clinical program is focused on clinical combinations, including with binimetinib, a MEK inhibitor, and independently with crizotinib, a cMET inhibitor, pursuant to a clinical trial and supply agreement with Pfizer.

    IDEAYA plans to present translational data at AACR retrospectively evaluating cMET expression in clinical biopsies from MUM patients in an IDE196 Phase 1 clinical trial, as well as preclinical data evaluating synergy between IDE196 and crizotinib in relevant cell models of a liver tumor microenvironment, a site of approximately 90% of uveal melanoma metastases.

    "We identified a cMET inhibitor as a potential combination agent through our translational research, and we believe these preclinical data provide a compelling biological rationale for the IDE196 and crizotinib combination to treat patients with metastatic uveal melanoma," said Matthew Maurer, M.D., Vice President, Head of Clinical Oncology and Medical Affairs at 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 the various presentations at the 2021 Annual Meeting of AACR .  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 November 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.   

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-announces-presentations-at-aacr-annual-meeting-2021-for-synthetic-lethality-programs-ide397-and-parg-and-kinase-inhibitor-ide196-301245261.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  19. SOUTH SAN FRANCISCO, Calif., March 1, 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 at the following upcoming investor relations events.

    Investor Relations Events

    • H.C. Wainwright Global Life Sciences Conference 2021 (Virtual)

      Corporate Presentation

      Tuesday, March 9th, 2021 at 7:00 am ET
    • Citi's 2021 Winter West Coast Biotech Virtual Bus Tour (Virtual)

      Fireside Chat with Analyst Mohit Bansal

      Tuesday, March 16th, 2021 at 3:00 pm ET
    • Oppenheimer's 31st Annual Healthcare Conference (Virtual)

      Company Presentation

      Wednesday, March 17th, 2021 at 2:30 pm ET
    • Roth 33rd Annual Conference (Virtual)

      Company Panel hosted by Analyst Zegbeh Jallah: "Highly Attractive Small Molecule

      Oncology Platforms" with Arvinas, IDEAYA Biosciences and Turning Point Therapeutics

      Wednesday, March 17th, 2021 at 5:00 pm ET

    A live audio webcast of selected events will be available by visiting the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at https://ir.ideayabio.com/news-events/investor-calendar.  A replay of selected webcasts 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 recent Quarterly Report on Form 10-Q filed on November 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-to-participate-in-upcoming-march-2021-investor-relations-events-301236947.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  20. SOUTH SAN FRANCISCO, Calif., Feb. 22, 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 IDEAYA's inaugural Synthetic Lethality Investor Day, with scientific presentations from IDEAYA, GlaxoSmithKline (GSK) and several Key Opinion Leaders, will be held virtually on Tuesday, April 20, 2021, at 1:00 pm - 3:00 pm ET / 10:00 am - 12:00 pm PT.

    Scientific Presenters / Participants will include:

    IDEAYA Biosciences:

    Michael Dillon, Ph.D., Senior Vice President, Chief Scientific Officer

    Mark Lackner, Ph.D., Senior Vice President, Head of Biology and Translational Sciences

    Matt Maurer, M.D., Vice President, Head of Clinical Oncology and Medical Affairs

    GlaxoSmithKline:

    Benjamin Schwartz, Ph.D., Vice President, Head of Oncology Synthetic Lethality Research Unit

    Key Opinion Leaders / IDEAYA Scientific Advisors:

    -  Alan D'Andrea, M.D., Director, Center of DNA Damage and Repair, Dana Farber Cancer Institute of Harvard Medical School

    William Sellers, M.D., Core Institute Member and Director of the Cancer Program of the Broad Institute of MIT and Harvard

    The agenda will focus on IDEAYA/GSK partnered and IDEAYA wholly-owned Synthetic Lethality programs, including IDE397, a potential best-in-class methionine adenosyltransferase 2A (MAT2A) inhibitor being evaluated in a Phase 1 clinical trial targeting methylthioadenosine phosphorylase (MTAP) deletion, which is prevalent in approximately 15% of all solid tumors. Agenda topics will also include poly(ADP-ribose) gylcohydrolase (PARG), a potential first-in-class wholly-owned program, and the IDEAYA / GSK partnered Polymerase Theta (Pol Theta) program. A Development Candidate is targeted for each of the PARG and PolTheta programs in 2021.  

    Agenda Topics:

    -  Synthetic Lethality: An Emerging Area within Precision Medicine and GSK-IDEAYA Partnership

    -  IDE397 Phase 1 Program: Targeting MAT2A in MTAP-Deleted Tumors

    -  Werner Helicase: Compelling Synthetic Lethality Target

    -  Pol Theta: Key Target in MMEJ DNA Damage Repair Pathway

    -  PARG: Novel Target in Clinically Validated Pathway

    "We believe IDEAYA's inaugural Synthetic Lethality Investor Day with presenters from IDEAYA, GSK and several academic luminaries in the field will be an exciting forum for the scientific, analyst, and investor communities. We will discuss key biological insights for several potential first-in-class targets, including PARG, Pol Theta, and Werner Helicase, as well as the competitive differentiation and clinical development plan of IDE397, a Phase 1 MAT2A inhibitor pursuing the MTAP-deletion patient population," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.  

    Additional information on the IDEAYA Synthetic Lethality Investor Day and registration for the event is available on IDEAYA's website at https://ir.ideayabio.com/events.

    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) potential first-in-class and best-in-class status, (ii) the timing, content and participants of  the Synthetic Lethality Investor Day, and (iii) the competitive differentiation of IDE397. 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 November 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.   

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-announces-inaugural-synthetic-lethality-investor-day-301231992.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  21. SOUTH SAN FRANCISCO, Calif., Feb. 17, 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 the appointment of Susan Kelley, M.D., to its Board of Directors.  

    Dr. Kelley brings over 25 years of experience in oncology drug research and development to IDEAYA. Most recently she served as Chief Medical Officer of the Multiple Myeloma Research Consortium (MMRC) where she led the strategic design and management of clinical trials in North America. Prior to the MMRC, she held positions of increasing responsibility at Bayer Healthcare Pharmaceuticals and Bayer-Schering Pharma, including Vice President, Global Clinical Development and Therapeutic Area Head – Oncology, where she led the team responsible for the development and worldwide regulatory approval of Nexavar® (sorafenib). Prior to joining Bayer, Dr. Kelley worked at Bristol-Myers Squibb in Oncology and Immunology drug development, ultimately serving as Executive Director, Oncology Clinical Research, at the Bristol-Myers Squibb Pharmaceutical Research Institute. She serves or has served as a member of the Board of Directors at multiple publicly traded companies including Deciphera Pharmaceuticals, Daré Bioscience, VBL Therapeutics Ltd, ArQule and Immune Design. Dr. Kelley received her M.D. from Duke University School of Medicine. She was a Fellow in Medical Oncology and Clinical Fellow in Medicine at Dana-Farber Cancer Institute, Harvard Medical School, and a Fellow in Medical Oncology and Pharmacology at Yale University School of Medicine, where she also served as a Clinical Assistant Professor of Medicine.

    "Susan's expertise in clinical oncology will be invaluable as we advance the Phase 1 IDE397 program in MTAP-deletion, evaluate potential Phase 2 expansion for the IDE196 / binimetinib combination, and target to select a Development Candidate for the potential first-in-class PARG Synthetic Lethality program this year," said Yujiro S. Hata, President and Chief Executive Officer, at IDEAYA Biosciences. 

    "I am excited to join IDEAYA as the company advances a broad preclinical and clinical stage precision medicine oncology pipeline, including several potential first-in-class Synthetic Lethality programs with compelling biomarker hypotheses, and the kinase inhibitor IDE196, an area in which I gained clinical experience through the development of various kinase inhibitors, including Nexavar®," said Dr. Kelley.   

    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 advancement of IDE397, (ii) the timing for selection of a development candidate for PARG, and (iii) the potential first-in-class and best-in-class status of programs.  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 November 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission. 

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-appoints-susan-l-kelley-md-an-industry-veteran-in-medical-oncology-and-clinical-development-to-its-board-of-directors-301229557.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  22. SOUTH SAN FRANCISCO, Calif., Feb. 8, 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 the effectiveness of the Investigational New Drug (IND) application for a Phase 1 clinical trial to evaluate IDE397, a potential best-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor. 

    IDE397 is IDEAYA's most advanced synthetic lethality program, and being developed in the clinic for cancer patients harboring methylthioadenosine phosphorylase (MTAP) deletion, which is prevalent in approximately 15% of all solid tumors.  IDEAYA is targeting a Q1 2021 First-Patient-In for the Phase 1 clinical trial of IDE397 in patients having solid tumors harboring MTAP deletion.

    IDEAYA also announced that Matthew Maurer, M.D., has joined the company as Vice President, Head of Clinical Oncology and Medical Affairs.  "Matt brings extensive clinical development and oncology experience in both the pharmaceutical industry and academia. His background in clinical oncology will be invaluable as we advance IDE397 clinically in MTAP-deletion and target to select the Development Candidate for our wholly-owned PARG program in 2021," said Yujiro S. Hata, President and Chief Executive Officer at IDEAYA Biosciences.

    Dr. Maurer has over 15 years of experience in oncology and previously worked at Bristol Myers Squibb (BMS) where he most recently led the clinical development of nivolumab and ipilimumab late phase studies in renal cell carcinoma and prostate cancer.  Prior to BMS, Dr. Maurer was a physician investigator and Assistant Professor of Medicine at Columbia University College of Physicians and Surgeons, where he served as a breast cancer specialist.  Dr. Maurer obtained his undergraduate degree from Princeton University and his medical degree from Mount Sinai School of Medicine, and then completed his residency at Columbia University Medical Center. 

    "I am thrilled to join the IDEAYA team and look forward to advancing the IDE397 clinical program and the broader Synthetic Lethality pipeline, including the PARG program, which has a potential application in breast cancer, an indication in which I have clinical experience as an oncologist," said Matthew Maurer, M.D., Vice President, Head of Clinical Oncology and Medical Affairs at IDEAYA Biosciences.

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

    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 timing of the First-Patient-In for IDE397 Phase 1 study and (ii) potential applications of the PARG program.  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 November 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.   

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-announces-ide397-ind-clearance-by-us-fda-to-initiate-phase-1-and-appointment-of-matthew-maurer-md-as-vice-president-head-of-clinical-oncology-and-medical-affairs-301223379.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  23. SOUTH SAN FRANCISCO, Calif., Feb. 1, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, announced its participation at the following upcoming investor relations events.

    Investor Relations Events

    • Guggenheim Healthcare Talks 2021 Oncology Day (Virtual)

      Fireside Chat with Analyst Michael Schmidt

      Friday, February 12th, 2021 at 12:00 pm ET

       
    • LifeSci Partners Precision Oncology Event (Virtual)

      Company Presentation

      Wednesday, February 17th, 2021, at 2:00pm ET

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

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including 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 recent Quarterly Report on Form 10-Q filed on November 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-to-participate-in-upcoming-february-2021-investor-relations-events-301218475.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  24. ATLANTA, Ga. and SOUTH SAN FRANCISCO, Calif., Jan. 19, 2021 /PRNewswire/ -- Spelman College and IDEAYA Biosciences, Inc. (NASDAQ:IDYA) announce partnership for professional development of the next generation of female African American leaders in the biotechnology industry through the Spelman College and IDEAYA Biosciences Health Science and Biotechnology Program.

    The Spelman IDEAYA partnership is a unique academic and industry collaboration that will provide Spelman students a learning platform for pursuing a career in the biotechnology industry, through the guiding principles of mentorship and education.

    The Spelman IDEAYA Health Science and Biotechnology Program will provide a professional internship and development program and scholarship for selected Spelman students who have interest in biotechnology as a potential future career path. IDEAYA's goal is to provide financial support and a unique and highly specialized experience for Spelman students with a longer-term objective to identify and develop the next generation of leaders in the biotechnology industry.

    The selected students from Spelman will be sponsored by IDEAYA and be provided a summer internship at the end of the students' sophomore year. Support of the interns will continue through the students' junior and senior years through tuition scholarships, biotechnology specific educational opportunities provided by IDEAYA and biotechnology industry focused career and graduate school advice provided through an IDEAYA mentor. IDEAYA will also provide programmatic support to the Spelman Environmental and Health Sciences Department.

    There will be an R&D and Business / Entrepreneurship track provided under the Spelman IDEAYA Health Science and Biotechnology Program.

    "IDEAYA Biosciences mission and strategic plan closely aligns with that of Spelman College," said Rosalind Gregory-Bass, M.D., associate professor of environmental and health sciences and director of Spelman's Health Careers Program. "Cancer health disparities among people of African descent are highly significant. The desire to be at the forefront of oncology-focused precision medicine is of extreme importance to the population we serve.   One key strategy to overcome these disparities is through Precision Medicine Technology.  It is important to the way we as a country revolutionize medicine in the pursuit of better healthcare outcomes."

    "As an institution with one of the nation's highest number of medical school applications from Black Americans, we are passionate about not only the discovery on new therapeutic options, but the delivery of the treatments as well," said Dr. Bass. "The technology being developed at IDEAYA will be pivotal to that end.  Spelman students and faculty can significantly contribute to these efforts and positively impact the company, overall."

    "We are ecstatic to partner with Spelman College in this scholarship program which we believe has the opportunity to identify and develop the next generation of female African American CEOs, entrepreneurs, and R&D executives and scientists in the biotechnology industry," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

    About Spelman College

    Founded in 1881, Spelman College is a leading liberal arts college widely recognized as the global leader in the education of women of African descent. Located in Atlanta, the College's picturesque campus is home to 2,100 students. Spelman is the country's leading producer of Black women who complete Ph.D.s in science, technology, engineering and math (STEM). The College's status is confirmed by U.S. News & World Report, which ranked Spelman No. 54 among all liberal arts colleges, No. 19 for undergraduate teaching, No. 4 for social mobility among liberal arts colleges, and No. 1 for the 14th year among historically Black colleges and universities. The Wall Street Journal ranked the College No. 3, nationally, in terms of student satisfaction. Recent initiatives include a designation by the Department of Defense as a Center of Excellence for Minority Women in STEM, a Gender and Sexuality Studies Institute, the first endowed queer studies chair at an HBCU, and a program to increase the number of Black women Ph.D.s in economics. New majors have been added, including documentary filmmaking and photography, and partnerships have been established with MIT's Media Lab, the Broad Institute and the Army Research Lab for artificial intelligence and machine learning. Outstanding alumnae include Children's Defense Fund founder Marian Wright Edelman, Starbucks Group President and COO Rosalind Brewer, political leader Stacey Abrams, former Acting Surgeon General and Spelman's first alumna president Audrey Forbes Manley, actress and producer Latanya Richardson Jackson, global bioinformatics geneticist Janina Jeff and authors Pearl Cleage and Tayari Jones. For more information, visit www.spelman.edu.

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 the effects of the Spelman IDEAYA Health Science and Biotechnology Program. 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 November 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/spelman-college-and-ideaya-biosciences-announce-partnership-for-professional-development-of-the-next-generation-of-female-african-american-leaders-in-the-biotechnology-industry-301209801.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  25. SOUTH SAN FRANCISCO, Calif., Jan. 11, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, today announced it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE397, a small molecule methionine adenosyltransferase 2a (MAT2A) inhibitor, for the treatment of patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion.

    "The IDE397 IND submission is an important milestone for IDEAYA as we advance our broader synthetic lethality pipeline of potential first-in-class therapies. IDE397 was discovered through our efforts to develop a potential best-in-class MAT2A inhibitor, and we have achieved our target product profile," said Michael Dillon, Ph.D., Chief Scientific Officer, IDEAYA Biosciences. "IDE397 is highly selective and active in the MTAP-deletion setting, which represents approximately 15% of all solid tumors, and we are excited about the potential impact IDE397 can make for these patients," said Yujiro S. Hata, Chief Executive Officer, IDEAYA Biosciences.

    IDEAYA Biosciences will present a program update on IDE397 and its broader synthetic lethality pipeline at the 39th Annual J.P. Morgan Healthcare Conference.  The presentation will include preclinical data demonstrating IDE397 monotherapy tumor regressions in PDX models with MTAP-deletion across several solid tumor types.  IDEAYA will also present its proposed IDE397 Phase 1 clinical plan in MTAP-deleted solid tumors, including monotherapy and combination strategies, and discuss the combination rationale for IDE397 and GSK's Type I PRMT inhibitor GSK3368715.  

    IDEAYA's presentation for the 39th Annual J.P. Morgan Healthcare Conference is available at https://ir.ideayabio.com/.

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 the potential impact of IDE397.  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 November 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-announces-submission-of-ind-application-for-mat2a-development-candidate-ide397-with-the-us-fda-301204730.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  26. SOUTH SAN FRANCISCO, Calif., Jan. 5, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, announced First-Patient-In (FPI) in the Phase 1 combination study of IDE196 and crizotinib, a cMET inhibitor, in metastatic uveal melanoma (MUM). The clinical combination of IDE196 and crizotinib is being evaluated by IDEAYA in collaboration with Pfizer pursuant to a clinical trial collaboration and supply agreement.

    "IDEAYA is executing on its clinical trial strategy to evaluate IDE196 combination therapies in Metastatic Uveal Melanoma (MUM). We identified cMET as a potential combination agent through our translational research, including evaluation of cMET expression in MUM patient clinical samples from an IDE196 Phase 1 clinical trial and preclinical demonstration of synergy between IDE196 and crizotinib, going from bench to bedside in approximately one year," said Mick O'Quigley, Vice President, Head of Development Operations. IDEAYA plans to present preclinical translational data supporting the IDE196/crizotinib combination therapy in H1 2021.

    "IDEAYA's clinical trials evaluating IDE196 plus either crizotinib or binimetinib as combination therapies are each based on compelling biological rationale for treating patients with metastatic uveal melanoma – a solid tumor for which there is a high unmet medical need and currently no approved therapies," said Meredith McKean, MD, MPH, Associate Director, Melanoma and Skin Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology.

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 the timing of presentation of preclinical translational data supporting the IDE196 / crizotinib combination therapy.  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 November 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-doses-first-patient-in-a-phase-1-combination-study-of-ide196-and-crizotinib-a-cmet-inhibitor-301199950.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  27. SOUTH SAN FRANCISCO, Calif., Jan. 4, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, announced its participation at the following upcoming investor relations events and scientific conferences.

    Investor Relations Events

    • JP Morgan 39th Annual Healthcare Conference 2021 (Virtual)

      Company Presentation

      Wednesday, January 13th, 2021 at 5:20 pm ET
    • HC Wainwright Bioconnect (Virtual)

      Company Presentation

      Thursday, January 14th, 2021, at 6:00 am ET

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

    Scientific Conferences

    • PARP & DDR Inhibitors Summit 2021 (Digital)

      Presentation Session – Next Generation Synthetic Lethal Interactions

      "Pharmacological inhibition of DNA polymerase theta (Polq) activity shows promise as novel treatment for homologous recombination deficient tumors"

      Thursday, January 28th, 2021 at 2:15 pm ET

    The PARP & DDR Inhibitors Summit will be held January 26th-28th, 2021. See http://parp-ddr-inhibitors-summit.com/about/the-summit/.

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing. IDEAYA is applying these capabilities across multiple classes of precision medicine, including 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 and scientific conferences. 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 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-to-participate-in-upcoming-january-2021-investor-relations-events-and-scientific-conferences-301199949.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  28. SOUTH SAN FRANCISCO, Calif., Dec. 14, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, announced today that it has been selected for addition to the NASDAQ Biotechnology Index. The addition to the NASDAQ Biotechnology Index will become effective prior to market open on Monday, December 21, 2020.

    The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on the NASDAQ Stock Market® (NASDAQ®) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB). The NASDAQ Biotechnology Index is re-ranked annually and all securities in the index are listed on the NASDAQ Global Market or the NASDAQ Global Select Market, and meet minimum market value and share volume requirements among other criteria.

    The NASDAQ Biotechnology Index is the basis for the iShares NASDAQ Biotechnology IndexSM Fund. In addition, options based on the iShares NASDAQ Biotechnology Index Fund trade on various exchanges. For more information about the NASDAQ Biotechnology Index visit www.nasdaq.com.

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 inclusion in the Nasdaq Biotechnology Index (NBI). 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 November 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-announces-addition-to-nasdaq-biotechnology-index-301191570.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  29. SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, provided a business update and announced financial results for the third quarter ended September 30, 2020.

    "We are advancing a broad pipeline of potential first-in-class synthetic lethality programs and executing on our IDE196 clinical strategy, including MEK and cMET combinations in MUM, and monotherapy development in skin melanoma and additional non-MUM GNAQ/11 solid tumors. Our synthetic lethality pipeline includes three programs recently partnered with GSK targeting MAT2A, Pol Theta and Werner Helicase, as well as three wholly-owned or controlled programs targeting PARG, DNA Damage Target 1 (DDT1) and DNA Damage Target 2 (DDT2).  We are continuing to invest in our synthetic lethality platform, including through our strategic partnerships with the Broad Institute and UCSD, and enhancing our internal research capabilities to extend our leadership in synthetic lethality," 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 developing IDE397, a potent and selective small molecule inhibitor targeting MAT2A, for solid tumors with MTAP deletions, a patient population estimated to represent approximately 15% of solid tumors.   IDEAYA continues to lead research and development on the MAT2A program through early clinical development.  Subject to exercise of its option, GSK will lead later stage global clinical development.  Highlights:

    • Evaluating efficacy of monotherapy IDE397 in over forty patient-derived xenograft (PDX) models with homozygous MTAP deletions in solid tumors;
    • Completed in-life phase of good laboratory practice (GLP)-compliant toxicology studies with IDE397 in two species;
    • Targeting IND submission for IDE397 in December 2020, subject to satisfactory completion of GLP toxicology studies and completion of chemistry, manufacturing and control, or CMC, certification requirements;
    • Plan to initiate a Phase 1 clinical trial for clinical evaluation of IDE397 as monotherapy in the first half of 2021, subject to effectiveness of the IND; and
    • IDEAYA and GSK are evaluating a potential phase 1 combination clinical trial for IDE397 and GSK's Type I PRMT inhibitor, GSK3368715.

    PARG

    IDEAYA is advancing preclinical research for an inhibitor of PARG.  PARG inhibitors have shown synthetic lethality with tumors harboring homologous recombination deficiency (HRD) mutations and potentially other genetic and/or molecular signatures.   Highlights:

    • Demonstrated monotherapy PARG inhibitor in vivo efficacy in multiple PDX models
    • Entered into a strategic collaboration with the Broad Institute of MIT and Harvard, pursuant to which in a PARG program initiative, IDEAYA and Broad Institute will evaluate paralog CRISPR knockdown in selected cell lines in conjunction with pharmacological inhibition of PARG to inform patient selection and combination strategies in ovarian and breast cancer; and
    • Targeting to identify a PARG inhibitor development candidate in 2021.

    Pol Theta

    IDEAYA's Pol Theta program targets tumors with BRCA or other 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
    • Targeting selection of a Pol Theta inhibitor development candidate in 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.  

    DNA Damage Targets

    IDEAYA has initiated multiple preclinical synthetic lethality research programs, designated as DDT1 and DDT2, to identify small molecule inhibitors for DNA Damage Targets (DDT's) for patients with solid tumors characterized by a proprietary biomarker or gene signature. 

    Synthetic Lethality Platform

    IDEAYA continues to build its synthetic lethality platform, investing in target identification, biomarker discovery and drug discovery, including small molecules and protein degraders, to create and sustain an industry leading synthetic lethality pipeline. Highlights:

    • Synthetic lethality research platform integrates computational and functional capabilities to identify synthetic lethal pairs in defined patient populations; the platform includes parallel data sets with orthogonal content based on screens of curated, genetically defined model cells, including IDEAYA-proprietary libraries and data sets such as PAGEO™ and DECIPHER™, partnership data sets such as DepMap and Foundation Insights™, and multiple public databases.
    • PAGEO™ Paralogous Gene Evaluation in Ovarian Cancer – Broad Institute
      • Entered into a strategic collaboration with the Broad Institute of MIT and Harvard focused on synthetic lethality target and biomarker discovery
      • Collaboration will use large-scale CRISPR paralog screening platform developed at the laboratory of William R. Sellers, M.D., Core Institute Member, Broad Institute, to evaluate functionally redundant paralogous genes across ovarian cancer subtypes and to generate novel target and biomarker hypotheses
      • Dr. Sellers, who also serves on IDEAYA Scientific Advisory Board, is the principal investigator for the strategic collaboration
    • DECIPHER™ Dual CRISPER Synthetic Lethality Library – UCSD
      • Constructed DECIPHER Dual CRISPR library for synthetic lethality target and biomarker discovery in collaboration with the University of California, San Diego
      • Bioinformatics analysis and validation ongoing for DECIPHER 1.0 library, focused on DNA Damage Repair targets across various tumor suppressor genes and oncogenes selected based on their known prevalence and role in solid tumors
    • DepMap (Cancer Dependency Map) – Broad Institute
      • Joined the DepMap (Cancer Dependency Map) consortium led by the Broad Institute, through which we have access to a comprehensive data set of genome-wide cell-based synthetic lethality screens conducted by the Broad and other contributing institutes, including pre-publication access to new data releases

    IDE196 (PKC)

    IDEAYA continues to execute on its clinical trial strategy to evaluate IDE196 combination therapies in Metastatic Uveal Melanoma (MUM) and to evaluate IDE196 monotherapy in Non-MUM solid tumors harboring activating GNAQ/11 mutations.  Interim data for each of the IDE196 / binimetinib combination arm for MUM and the IDE196 monotherapy arm of the Phase 1/2 basket trial is anticipated in 2021.

    Combination Therapies

    IDEAYA expanded the scope of its clinical trial and supply agreement with Pfizer to evaluate IDE196 and crizotinib, a cMET inhibitor, as a combination therapy in patients having tumors harboring activating GNAQ or GNA11 hotspot mutations.  This extends the prior relationship to evaluate IDE196 and binimetinib, a MEK inhibitor, as a combination therapy in such patients.  Highlights:

    • Pfizer will supply IDEAYA with their cMET inhibitor, crizotinib, in addition to their MEK inhibitor, binimetinib, to support the IDEAYA-sponsored clinical combination trials
    • Targeting initiation of the IDE196/crizotinib study in late 2020 to early 2021
    • Continuing enrollment into the IDE196 / binimetinib combination arm under the clinical trial collaboration and supply agreement with Pfizer and targeting combination expansion in Q1 2021;

    Monotherapy

    IDEAYA is actively enrolling patients into the IDE196 monotherapy Phase 2 tissue-type agnostic basket arm in Non-MUM solid tumors having GNAQ or GNA11 hotspot mutations, including skin melanoma and other tumor types. Highlights:

    • As of November 1, 2020, enrolled a total of 7 patients with GNAQ/11-mutated non-MUM solid tumors into the Phase 2 monotherapy arm, including 6 patients with skin melanoma; and
    • Ongoing enrollment for Phase 2 cohort expansion in skin melanoma.

    General

    IDEAYA completed 13-week GLP-compliant toxicology studies for IDE196 in two species.

    IDEAYA continues to monitor Covid-19 and its potential impact on clinical trials and timing of clinical data results.  Ongoing monitoring of enrolled patients, including obtaining patient computed tomography (CT) scans, may be impacted, and new patient enrollment into the Phase 2 expansion arm for IDE196 as a monotherapy in non-MUM solid tumors having GNAQ or GNA11 hotspot mutations may be delayed; the specific impacts are currently uncertain.

    Corporate Updates

    IDEAYA anticipates that existing cash, cash equivalents, and short-term and long-term marketable securities of $288.8 million as of September 30, 2020 will be sufficient to fund planned operations into 2024, and through potential achievement of multiple preclinical and clinical milestones across multiple programs.   

    Our updated corporate presentation is available on our website, in the Presentations section of our Investor Relations page. See: https://ir.ideayabio.com/news-events/presentations

    Financial Results

    As of September 30, 2020, IDEAYA had cash, cash equivalents, and short-term and long-term marketable securities totaling $288.8 million. This compared to cash, cash equivalents and short-term marketable securities of $100.5 million at December 31, 2019.  The increase was primarily due to $100.7 million in net proceeds from IDEAYA's follow-on public offering, $100.0 million from the upfront payment received from GSK, and $20.0 million in net proceeds from the private placement with GSK received through September 30, 2020.

    Collaboration revenue for the three months ended September 30, 2020 totaled $9.0 million compared to zero for the same period in 2019. Collaboration revenue was recognized for the performance obligations satisfied through September 30, 2020 under the GSK Collaboration Agreement.

    Research and development (R&D) expenses for the three months ended September 30, 2020 totaled $10.0 million compared to $8.9 million for the same period in 2019. The increase was primarily due to the Phase 1/2 clinical trial to evaluate IDE196 in solid tumors, and the advancement of our lead product candidates through preclinical studies and regulatory support activity, offset by a decrease in laboratory supplies and payroll expense.

    General and administrative (G&A) expenses for the three months ended September 30, 2020 totaled $3.9 million compared to $2.7 million for the same period in 2019. The increase was primarily due to an increase in G&A headcount costs and an increase in consulting expenses.

    The net loss for the three months ended September 30, 2020 was $4.9 million compared to $11.0 million for the same period in 2019. Total stock compensation expense for the three months ended September 30, 2020 was $1.0 million compared to $0.5 million for the same period in 2019.

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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.   

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to (i) the timing of filing of an IND and initiation of a Phase 1 clinical trial for IDE397, (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 release of interim data for the IDE196/binimetinib combination arm of the Phase 1/2 GNAQ/11 basket trial, (v) the timing of release of interim data for the IDE196 monotherapy arm of the Phase 1/2 GNAQ/11 basket trial, (vi) the extent to which IDEAYA's existing cash, cash equivalents, and marketable securities will fund its planned operations, and (vii) the timing of initiation of the IDE196/crizotinib study. 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 November 12, 2020 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

    September 30,





    Nine Months Ended

    September 30,







    2020





    2019





    2020





    2019



    Collaboration revenue



    $

    8,967





    $





    $

    8,967





    $



    Total revenue





    8,967













    8,967









    Operating expenses

































    Research and development





    10,024







    8,923







    27,647







    25,778



    General and administrative





    3,939







    2,700







    11,384







    7,174



    Total operating expenses





    13,963







    11,623







    39,031







    32,952



    Loss from operations





    (4,996)







    (11,623)







    (30,064)







    (32,952)



    Interest income and other income (expense),

         
    net





    70







    654







    704







    1,758



    Net loss



    $

    (4,926)





    $

    (10,969)





    $

    (29,360)





    $

    (31,194)



    Change in unrealized gains (losses) on

         
    marketable securities





    (22)







    41







    (30)







    109



    Comprehensive loss



    $

    (4,948)





    $

    (10,928)





    $

    (29,390)





    $

    (31,085)



    Net loss per share attributable to common

        stockholders, basic and diluted



    $

    (0.17)





    $

    (0.54)





    $

    (1.26)





    $

    (3.15)



    Weighted average number of shares outstanding,

        basic and diluted





    28,396,670







    20,158,223







    23,235,218







    9,895,574



     

    _____________

     

     IDEAYA Biosciences, Inc.

    Condensed Balance Sheet Data

    (in thousands)







    September 30,





    December 31,







    2020





    2019



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

         
    marketable securities



    $

    288,841





    $

    100,482



    Total assets





    301,384







    113,001



    Total liabilities





    105,955







    12,601



    Total liabilities and stockholders' equity





    301,384







    113,001



     

    ______________

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-inc-reports-third-quarter-2020-financial-results-and-provides-business-update-301171396.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  30. SOUTH SAN FRANCISCO, Calif., Nov. 2, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, announced that management will present at the following upcoming investor relations events.

    • Stifel 2020 Healthcare Conference (Virtual)

      Company Presentation

      Monday, November 16th, 2020, at 1:00 pm PT / 4:00 pm ET
    • Jefferies London Healthcare Conference (Virtual)

      Fireside Chat hosted by Analyst Maury Raycroft

      Wednesday, November 18th, 2020 at 9:35 am PT / 12:35 pm ET / 5:35 pm GMT

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

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including 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 recent Quarterly Report on Form 10-Q filed on August 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-to-participate-in-upcoming-november-2020-investor-relations-events-301164414.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  31. SOUTH SAN FRANCISCO, Calif., Oct. 22, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, announced today that it has entered into a target and biomarker discovery partnership with the Sellers Laboratory at the Broad Institute of MIT and Harvard.

    The IDEAYA partnership with the laboratory of William R. Sellers, M.D., Core Institute Member, Broad Institute, will utilize the CRISPR paralog screening platform developed at the Broad Institute to evaluate functionally redundant paralogous genes across ovarian cancer subtypes and to generate novel Synthetic Lethality (SL) based target and biomarker discoveries. In addition, the IDEAYA and Broad collaboration will evaluate paralog CRISPR knockdown in selected cell lines in conjunction with pharmacological inhibition of PARG to inform patient selection and combination strategies in both ovarian and breast cancer.  IDEAYA has also become a member of the DepMap (Cancer Dependency Map) consortium led by Broad Institute to further enhance IDEAYA's efforts in bioinformatics and cell-based screening for SL target and biomarker discovery and validation.

    "Our lab has developed large-scale screening approaches to identify and validate novel Synthetic Lethal interactions, and we look forward to collaborating with IDEAYA to translate this research for the discovery of potential patient-selection biomarkers and cancer therapeutics," said Sellers, who also serves on the IDEAYA scientific advisory board.  "We are delighted to collaborate with the Sellers Lab at the Broad Institute and leverage their molecular biology expertise and paralog CRISPR screening approach to enhance our Synthetic Lethality target and biomarker discovery efforts," said Michael P. Dillon, Ph.D., Chief Scientific Officer, IDEAYA Biosciences. 

    Update on IDEAYA SL Platform and Programs:

    IDEAYA has constructed its DECIPHER Dual CRISPR Synthetic Lethality platform for SL target and biomarker discovery in collaboration with the University of California, San Diego, and bioinformatics analysis and preclinical validation are ongoing.  The DECIPHER 1.0 library is focused on DNA Damage Repair targets across various tumor suppressor genes and oncogenes of interest that were selected based on their known prevalence and role in solid tumors, enabling evaluation of approximately 50,000 independent gene knockout combinations of DDR pathway related drug targets across known tumor suppressor genes.

    In addition to its three GSK-partnered Synthetic Lethality programs in MAT2A, Pol Theta and Werner Helicase, IDEAYA has several wholly owned SL and DNA Damage Target (DDT) programs, including PARG and multiple additional SL / DDT preclinical programs. 

    The PARG program is targeting Development Candidate nomination in 2021.  Patient selection biomarker validation is ongoing for PARG, including a panel of PDX models in select tumor types and in defined genetic settings.  IDEAYA is also advancing additional preclinical SL / DDT programs that are potential first-in-class programs.

    "We are executing on our strategy to build the industry leading Synthetic Lethality focused biotechnology company, including through strategic partnerships.  The Broad and earlier announced GSK partnership advances our efforts to extend our research leadership in Synthetic Lethality and to build a diverse pipeline of potential first-in-class Synthetic Lethality programs," said Yujiro S. Hata, President and CEO, IDEAYA Biosciences.

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and 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 generation of novel SL based target and biomarker discoveries and (ii) the timing of nomination of a PARG development candidate.  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 recent Quarterly Report on Form 10-Q filed on August 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-announces-partnership-with-the-broad-institute-and-advancement-of-synthetic-lethality-programs-and-platform-301157599.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  32. SOUTH SAN FRANCISCO, Calif., Sept. 24, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, today announced that it has expanded its clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE:PFE) for an IDEAYA sponsored clinical combination study of IDE196, a Protein Kinase C (PKC) inhibitor, and crizotinib, a cMET inhibitor to which Pfizer has exclusive worldwide rights. The study will evaluate IDE196 and crizotinib combination therapy in patients with solid tumors having GNAQ or GNA11 mutations (GNAQ/11), including metastatic uveal melanoma (MUM), skin melanoma, lung cancer and colorectal…

    SOUTH SAN FRANCISCO, Calif., Sept. 24, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, today announced that it has expanded its clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE:PFE) for an IDEAYA sponsored clinical combination study of IDE196, a Protein Kinase C (PKC) inhibitor, and crizotinib, a cMET inhibitor to which Pfizer has exclusive worldwide rights. The study will evaluate IDE196 and crizotinib combination therapy in patients with solid tumors having GNAQ or GNA11 mutations (GNAQ/11), including metastatic uveal melanoma (MUM), skin melanoma, lung cancer and colorectal cancer.

    Evaluating MUM patient clinical samples, IDEAYA identified cMET expression or activation as a potentially valuable biomarker that may guide IDE196 clinical treatment in this indication. IDEAYA also demonstrated preclinical synergy in MUM with the combination of IDE196 and crizotinib, which further supports the potential biomarker on cMET expression.

    "We are excited to expand our agreement with Pfizer to evaluate the clinical combination of IDE196 and crizotinib in MUM and other solid tumors with GNAQ or GNA11 mutations," said Mick O'Quigley, Vice President, Head of Development Operations, IDEAYA Biosciences. "Through our translational research we have identified cMET expression as a potential biomarker, and we are excited to explore this rational combination between IDE196 and crizotinib clinically," said Mark Lackner, Ph.D., Senior Vice President, Head of Biology and Translational Sciences.

    IDEAYA's clinical development plan in MUM for IDE196 is based on combination therapies, including with binimetinib, a MEK inhibitor, and crizotinib, a cMET inhibitor, enabled through our clinical trial collaboration and drug supply agreement with Pfizer. The company announced First-Patient-In (FPI) for the IDE196 and binimetinib clinical combination in June 2020 and is targeting FPI for the crizotinib clinical trial combination in late 2020 to early 2021. IDEAYA is also evaluating IDE196 as monotherapy in an ongoing GNAQ/11 non-MUM basket trial in additional solid tumor types, including in skin melanoma, where the company announced Phase 2 expansion.

    IDEAYA and Pfizer have established a Joint Development Committee (JDC), and there will be joint decision making and data sharing of the clinical trial results between the parties. IDEAYA will sponsor the study and Pfizer will provide the crizotinib drug supply. If there is clinical data from the collaboration studies that could be used to obtain regulatory approvals or label changes, IDEAYA and Pfizer will enter into good faith negotiations to determine a regulatory submission strategy.

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing. IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and 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 clinical potential of crizotinib in combination with IDE196, including whether the combination will enhance the response rate, and the depth and durability of clinical benefit and (ii) the timing of initiation of the combination clinical trial of IDE196 plus crizotinib in late 2021 to early 2022. 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 recent Quarterly Report on Form 10-Q filed on August 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-and-pfizer-expand-clinical-trial-collaboration-and-supply-agreement-to-evaluate-clinical-combination-of-ide196-and-crizotinib-in-solid-tumors-harboring-gnaq-or-gna11-mutations-301137168.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  33. SOUTH SAN FRANCISCO, Calif., Aug. 31, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, announced that management will present at the following upcoming investor relations events.

    • JP Morgan CEO Series

      Fireside Chat hosted by Analyst Anupam Rama

      Tuesday, September 8, 2020 at 12:00pm ET
    • Citi 15th Annual BioPharma Conference

      Company Panel: Precision Targeted Drugs in Oncology hosted by Analyst Mohit Bansal

      Wednesday, September 9th at 11:40am ET
    • RW Baird Global Health Care Conference

      Fireside Chat hosted by Analyst Madhu Kumar

      Thursday, September 10th at 3:45pm ET
    • H.C. Wainwright 22nd Annual Global Investment Conference

      Company Presentation

      Monday, September 14th at 11:30am ET
    • Cantor Fitzgerald Global Healthcare Conference

      Company Presentation

      Thursday, September 17th at 4:40pm ET

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

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including 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 recent Quarterly Report on Form 10-Q filed on August 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-to-participate-in-upcoming-september-2020-investor-relations-events-301120557.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  34. SOUTH SAN FRANCISCO, Calif., Aug. 12, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine 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, 2020.

    "This quarter was transformational for IDEAYA.  We have cash runway into 2024, with quarter-end cash, cash equivalents and marketable securities of $172.0 million supplemented by $127.5 million aggregate gross proceeds received subsequently, including $100 million non-dilutive upfront cash and $20 million private placement equity investment from GSK.  In addition, through our GSK strategic partnership and our Pfizer collaboration and supply agreement, we have established an attractive cost structure and retained significant future upside across our pipeline, while also creating opportunities for non-dilutive cash milestones of approximately $3 billion across three programs with GSK.  We also nominated MAT2A development candidate IDE397, initiated the IDE196 and binimetinib Phase 1 combination, and met the criteria for IDE196 Phase 2 expansion in skin melanoma.  As we celebrate our five-year anniversary, we have built a strong foundation to create the industry leading Synthetic Lethality-focused precision medicine oncology company," said Yujiro S. Hata, Chief Executive Officer and President of IDEAYA Biosciences.

    GlaxoSmithKline Strategic Partnership

    IDEAYA and GSK entered into a strategic partnership in Synthetic Lethality focused on IDEAYA's MAT2A, Pol Theta, and Werner Helicase programs – each of which has a strong rationale for collaborating, including potential clinical combinations with GSK precision medicine therapeutics.  The strategic partnership includes small molecule and protein degrader modalities.    

    IDEAYA retains all rights and interests in its other pipeline assets, including preclinical programs targeting PARG and a proprietary DNA Damage Target, as well as its clinical candidate IDE196 for patients having tumors harboring GNAQ or GNA11 hotspot mutations.

    Program Updates

    Key highlights for IDEAYA's pipeline programs include:

    MAT2A

    IDEAYA's lead synthetic lethality research program targets MAT2A for solid tumors with MTAP deletions, a patient population estimated to represent approximately 15% of solid tumors.   IDEAYA continues to lead research and development on the MAT2A program through early clinical development.  Subject to exercise of its option, GSK will lead later stage global clinical development.  Highlights:

    • Designated MAT2A inhibitor IDE397 as a development candidate;
    • Demonstrated IDE397 in vivo dose-dependent efficacy and tumor regression (with >100% TGI, or tumor growth inhibition) as monotherapy in an endogenous non-small cell lung cancer MTAP-null PDX model;
    • Initiated good laboratory practice (GLP)-compliant toxicology studies with IDE397 in two species;
    • On track for IND submission to the FDA for IDE397 in the fourth quarter of 2020, subject to satisfactory completion of GLP toxicology studies;
    • Plan to initiate a Phase 1 clinical trial for clinical evaluation of IDE397 as monotherapy in the first half of 2021, subject to effectiveness of the IND; and
    • IDEAYA and GSK are evaluating a potential phase 1 combination clinical trial for IDEAYA's MAT2A inhibitor (IDE397) and GSK's Type I PRMT inhibitor (GSK3368715).

    PARG

    IDEAYA is advancing preclinical research for an inhibitor of poly (ADP-ribose) glycohydrolase, or PARG.  PARG inhibitors have shown synthetic lethality with tumors harboring BRCA2 mutations, impaired base excision repair, or BER, and potentially other genetic and/or molecular signatures.   Highlights:

    • Demonstrated in vivo proof of concept in a relevant animal model having a replication stress genetic signature;
    • Validating a potential synthetic lethality biomarker for identifying tumor cells having sensitivity to a PARG inhibitor;
    • Observed monotherapy PARG inhibitor in vivo efficacy in multiple PDX models, including tumor regression; and
    • Targeting to identify a PARG inhibitor development candidate in 2021

    Pol Theta

    IDEAYA's Pol Theta program targets tumors with BRCA or other homologous recombination deficiency (HRD) mutations.  IDEAYA and GSK will collaborate on ongoing preclinical research, including small molecules and protein degraders, and GSK will lead clinical development for the Pol Theta program.   Subject to such preclinical studies, we are targeting to file an IND for a Pol Theta inhibitor in 2021.  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

    Werner Helicase

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

    Expanding Synthetic Lethality Pipeline and Synthetic Lethality Platform

    IDEAYA has initiated additional preclinical synthetic lethality research programs, including for a DNA Damage Target (DDT), for patients with solid tumors characterized by a proprietary biomarker or gene signature. 

    IDEAYA continues to build its Synthetic Lethality platform, investing in target identification, biomarker discovery and drug discovery, including small molecules and protein degraders, to create the industry leading Synthetic Lethality and DNA Damage based pipeline.

    IDE196

    IDEAYA continued to execute on its clinical trial, initiated in June 2019, to evaluate IDE196 in Metastatic Uveal Melanoma (MUM) and Non-MUM solid tumors harboring activating GNAQ/11 mutations.  The clinical development strategy for IDE196 is focused on evaluating IDE196 combination therapy for the MUM indication, and evaluating IDE196 monotherapy in non-MUM GNAQ/11 hotspot mutation solid tumors, such as skin melanoma.

    Combination Therapy

    IDEAYA is enrolling MUM patients into a combination arm of the IDE196 Phase 1/2 clinical trial to evaluate safety and efficacy of IDE196 in combination with binimetinib, a MEK inhibitor.  We may also evaluate IDE196 / binimetinib combination therapy in patients having other solid tumors with activating GNAQ/11 hotspot mutations, such as skin melanoma.  The combination arm is being conducted under a clinical trial collaboration and supply agreement with Pfizer Inc., pursuant to which Pfizer supplies us with their MEK inhibitor, binimetinib; the companies established a Joint Development Committee with Pfizer to facilitate combination arm drug supply, trial initiation and ongoing development. Highlights:   

    • First-Patient-In (FPI) of a MUM patient for IDE196 / binimetinib combination arm of the IDE196 clinical trial in June 2020;
    • Initiated dosing into a first cohort of the IDE196 / binimetinib dose escalation portion of combination arm; and
    • Interim data from evaluation of IDE196 / binimetinib combination therapy anticipated in late 2021 to early 2022.

    Monotherapy

    IDEAYA is actively enrolling into the IDE196 monotherapy Phase 2 tissue-type agnostic basket arm in Non-MUM solid tumors having GNAQ or GNA11 hotspot mutations, including skin melanoma. Highlights:

    • Clinical protocol criteria met for cohort expansion in cutaneous melanoma, or skin melanoma. Of 4 evaluable skin melanoma patients harboring GNAQ/11 hotspot mutations (out of 5 total enrolled; excluding 1 non-evaluable), a 100% Disease Control Rate was observed, and one confirmed partial response (cPR) was determined by RECIST 1.1 guidelines;
    • The skin melanoma patient with cPR observed an initial partial response (-31.1%) at 8 weeks, which was sustained at 20 weeks (-37%) with reduction in target liver lesion and inguinal lymph node. Treatment with IDE196 is ongoing as of August 1, 2020;
    • Dosed first leiomyosarcoma patient in the Phase 2 GNAQ/11 basket arm, expanding the tissue-agnostic approach to additional solid tumors;
    • Established a relationship with CARIS through which we are accessing their network of clinical trial sites into which we can enroll qualifying patients having tumors harboring GNAQ/11 hotspot mutations; and
    • Interim data from the monotherapy arm of the Phase 2 basket trial anticipated in first half of 2021.

    General

    IDEAYA completed IDE196 tablet formulation and successfully introduced the tablet in the ongoing clinical trial, including the IDE196 / binimetinib combination arm and the GNAQ/11 basket arm.

    IDEAYA completed 13-week GLP-compliant toxicology studies in two species, with receipt of submission-ready audited draft reports.

    IDEAYA continues to monitor Covid-19 and its potential impact on clinical trials and timing of clinical data results.  Covid-19 infection rates have increased recently in several states in which our clinical trial sites are located. As such, ongoing monitoring of enrolled patients, including obtaining patient computed tomography (CT) scans, may be impacted, and new patient enrollment into the Phase 2 expansion arm for IDE196 as a monotherapy in non-MUM solid tumors having GNAQ or GNA11 hotspot mutations may be delayed; the specific impacts are currently uncertain.

    Corporate Updates

    IDEAYA anticipates that existing cash, cash equivalents, and short-term and long-term marketable securities of $172.0 million as of June 30, 2020, together with the additional aggregate gross proceeds of $127.5 million received from GSK as up-front cash payment and from equity investments subsequent to June 30, 2020, will be sufficient to fund planned operations into 2024, and through potential achievement of multiple preclinical and clinical milestones across multiple programs.   

    Our updated corporate presentation is available on our website, in the Presentations section of our Investor Relations page. See: https://ir.ideayabio.com/news-events/presentations .

    Financial Results

    As of June 30, 2020, IDEAYA had cash, cash equivalents, and short-term and long-term marketable securities totaling $172.0 million. This compared to cash, cash equivalents and short-term marketable securities of $100.5 million at December 31, 2019.  The increase was primarily due to $93.6 million in net proceeds from IDEAYA's follow-on public offering through June 30, 2020.

    Research and development (R&D) expenses for the three months ended June 30, 2020 totaled $8.6 million compared to $8.9 million for the same period in 2019. The decrease was primarily due to a decrease in R&D headcount and laboratory supply costs, offset by an increase in costs related to our IDE196 clinical trial and the advancement of IDE397 through preclinical studies.

    General and administrative (G&A) expenses for the three months ended June 30, 2020 totaled $4.0 million compared to $2.4 million for the same period in 2019. The increase was primarily due to an increase in G&A headcount costs, director and officer insurance policy premiums, costs related to our shelf registration statement filing on Form S-3, and an increase in legal expenses.

    The net loss for the three months ended June 30, 2020 was $12.4 million compared to $10.7 million for the same period in 2019. Total stock compensation expense for the three months ended June 30, 2020 was $0.8 million compared to $0.5 million for the same period in 2019.

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and 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 extent to which IDEAYA's existing cash, cash equivalents, and marketable securities will fund its planned operations, (ii) the potential to receive cash payments under the GSK collaboration, (iii) the timing of filing of an IND and initiation of a Phase 1 clinical trial for IDE397, (iv) the timing of identification of a development candidate for a PARG inhibitor, (v) the timing of filing of an IND for a Pol Theta inhibitor, (vi) the potential to evaluate IDE196 / binimetinib combination in other solid tumor types, (vii) the timing of release of interim data for the IDE196 / binimetinib combination, and (viii) the timing of release of interim monotherapy data for the IDE196 Phase 1/2 basket trial. 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 12, 2020 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

    June 30,





    Six Months Ended

    June 30,







    2020





    2019





    2020





    2019



    Operating expenses

































    Research and development



    $

    8,596





    $

    8,859





    $

    17,622





    $

    16,855



    General and administrative





    3,994







    2,376







    7,446







    4,474



    Total operating expenses





    12,590







    11,235







    25,068







    21,329



    Loss from operations





    (12,590)







    (11,235)







    (25,068)







    (21,329)



    Interest income and other income (expense), net





    199







    579







    634







    1,104



    Net loss



    $

    (12,391)





    $

    (10,656)





    $

    (24,434)





    $

    (20,225)



    Change in unrealized gains (losses) on marketable securities





    57







    29







    (8)







    68



    Comprehensive loss



    $

    (12,334)





    $

    (10,627)





    $

    (24,442)





    $

    (20,157)



    Net loss per share attributable to common stockholders, basic and diluted



    $

    (0.59)





    $

    (1.30)





    $

    (1.18)





    $

    (4.32)



    Weighted average number of shares outstanding, basic and diluted





    21,001,730







    8,218,010







    20,626,139







    4,679,206



     

     

    IDEAYA Biosciences, Inc.

    Condensed Balance Sheet Data

    (in thousands)







    June 30,





    December 31,







    2020





    2019



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

         marketable securities



    $

    171,959





    $

    100,482



    Total assets





    184,510







    113,001



    Total liabilities





    12,452







    12,601



    Total liabilities and stockholders' equity





    184,510







    113,001



     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-inc-reports-second-quarter-2020-financial-results-and-provides-business-update-301110525.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  35. SOUTH SAN FRANCISCO, Calif., Aug. 4, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, announced the effectiveness of the Collaboration, Option and License Agreement between IDEAYA and GlaxoSmithKline Intellectual Property (No. 4) Limited (GSK) following clearance under the Hart-Scott-Rodino Antitrust Improvements Act (HSR). Pursuant to the Collaboration, Option and License Agreement, IDEAYA received an upfront cash payment of $100 million from GSK. The strategic partnership in Synthetic Lethality includes IDEAYA's MAT2A, Pol Theta, and Werner Helicase programs.

    SOUTH SAN FRANCISCO, Calif., Aug. 4, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, announced the effectiveness of the Collaboration, Option and License Agreement between IDEAYA and GlaxoSmithKline Intellectual Property (No. 4) Limited (GSK) following clearance under the Hart-Scott-Rodino Antitrust Improvements Act (HSR). Pursuant to the Collaboration, Option and License Agreement, IDEAYA received an upfront cash payment of $100 million from GSK. The strategic partnership in Synthetic Lethality includes IDEAYA's MAT2A, Pol Theta, and Werner Helicase programs.

    IDEAYA also announced closing of a direct private placement equity financing pursuant to a Stock Purchase Agreement between IDEAYA and Glaxo Group Limited (Glaxo Group). Glaxo Group purchased 1,333,333 shares of IDEAYA's common stock at a price per share of $15.00. IDEAYA received proceeds from Glaxo Group of approximately $20 million.

    IDEAYA expects current cash, cash equivalents and marketable securities to support planned operations into 2024.

    "The GSK partnership and our enhanced balance sheet enables IDEAYA to fund its operations through multiple key preclinical and clinical milestones for our Synthetic Lethality pipeline and IDE196," said Paul A. Stone, Chief Financial Officer, IDEAYA Biosciences.

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing. IDEAYA is applying these capabilities across multiple classes of precision medicine, including synthetic lethality – 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 length of operational and preclinical and clinical milestone support from IDEAYA's current cash, cash equivalents, and marketable securities, 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 12, 2020, the prospectus supplement related to the public offering and subsequent filings with the SEC.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-announces-hsr-clearance-of-gsk-strategic-partnership-in-synthetic-lethality-and-closing-of-glaxo-group-equity-investment-301105271.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  36. SOUTH SAN FRANCISCO, Calif., July 16, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, announced that it has met the clinical protocol criteria for cohort expansion in the cutaneous (skin) melanoma cohort of its Phase 2 basket arm evaluating IDE196 monotherapy in solid tumors harboring GNAQ or GNA11 hotspot mutations (GNAQ/11). 

    IDEAYA has enrolled 4 evaluable and 1 non-evaluable skin melanoma patients harboring GNAQ/11 mutations in an initial Stage 1 cohort of the study design.  Pursuant to the protocol, if no RECIST (Response Evaluation Criteria in Solid Tumors) responses are observed in the targeted 9 patients of Stage 1 cohort, no additional expansion patients are to be enrolled in that cohort; otherwise, a second Stage 2 of enrollment comprising of 15 additional patients may be enrolled for a total of 24 patients.  The 1 confirmed partial response in a GNAQ/11 mutation skin melanoma patient was determined by RECIST guidelines (version 1.1).    

    "I am pleased IDE196 has met the criteria for Stage 2 expansion in skin melanoma, as these patients with GNAQ/11 mutations may not have actionable BRAF driver mutations and may also have a low tumor mutational burden, and thus be less responsive to existing treatment options," said Marlana Orloff, M.D., Assistant Professor at Thomas Jefferson University Hospital in Philadelphia, who is a Principal Investigator on the IDEAYA clinical trial.

    IDEAYA continues to monitor Covid-19 and its potential impact on clinical trials and timing of clinical data results. Covid-19 infection rates have increased over the last weeks in several states in which our enrollment sites are located.

    Based on the increased target enrollment and potential impact of the Covid-19 pandemic, further IDE196 monotherapy interim data is anticipated to be in the first half of 2021.

    "IDE196 expansion in skin melanoma enables IDEAYA to build a larger data set and to explore potential combinations in this tumor type, and further validates our GNAQ/11 tissue-agnostic approach," said Mick O'Quigley, Vice President, Head of Development Operations at IDEAYA Biosciences. 

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and 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) enrollment of additional patients in Stage 2 of cohort expansion in Phase 2 GNAQ/11 basket trial, (ii) potential impact of Covid-19 on clinical trials and timing of clinical data results, and (iii) timing of IDE196 monotherapy interim data.   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 our 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 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-announces-ide196-program-update-and-clinical-protocol-criteria-met-for-cohort-expansion-in-skin-melanoma-for-phase-2-gnaq11-basket-trial-301094514.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  37. SOUTH SAN FRANCISCO, Calif., July 14, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, announced the Company will participate in the following upcoming investor conferences:

    • BTIG Virtual Biotechnology Conference on Tuesday, August 11, 2020 at 1:00 pm EST. Yujiro S. Hata, Chief Executive Officer and President, IDEAYA Biosciences, will participate in a fireside chat with Thomas Shrader, Ph.D., CFA, Equity Research Analyst, BTIG
    • Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 12, 2020 at 8:00 am EST. Yujiro S. Hata, Chief Executive Officer and President, IDEAYA Biosciences, will participate in a fireside chat with Robert Driscoll, Ph.D., Equity Research Analyst, Wedbush, including to discuss his recent industry report entitled "Exploiting Addiction: A Review of Synthetic Lethality in Cancer"

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

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including 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 recent Quarterly Report on Form 10-Q filed on May 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-to-participate-in-fireside-chat-at-btig-biotechnology-conference-and-wedbush-pacgrow-healthcare-conference-on-august-11-and-12-2020-301092618.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  38. SOUTH SAN FRANCISCO, Calif., July 9, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, announced First-Patient-In (FPI) in the Phase 1 combination study of IDE196 and binimetinib, a MEK inhibitor, in metastatic uveal melanoma (MUM).  The clinical combination of IDE196 and binimetinib is being evaluated by IDEAYA with binimetinib being supplied by Pfizer pursuant to a clinical trial collaboration and supply agreement.

    In the MUM setting, IDEAYA's clinical development strategy focuses on rational combinations, including MEK, and supporting studies through collaborations, such as the Pfizer clinical trial collaboration and supply agreement.  IDEAYA's strategic objective is to enhance the clinical activity of IDE196 through potential synergistic combinations.  In the non-MUM GNAQ/11 hotspot mutation basket trial, including skin melanoma, IDEAYA will continue to evaluate IDE196 monotherapy and potential combinations, such as with binimetinib.

    At the AACR Virtual Annual Meeting II held on June 22-24, 2020, IDEAYA presented an abstract on the preclinical evaluation of IDE196 plus MEK combination, entitled "Analysis of drug combinations with the PKC inhibitor IDE196 support dual MEK and PKC inhibition as a rational combination in metastatic uveal melanoma."

    "Our preclinical studies with IDE196 and MEK presented at AACR support our clinical development strategy to focus on combinations as the most promising approach for the MUM indication," said Mick O'Quigley, Vice President, Head of Development Operations. "In addition, we continue to evaluate IDE196 monotherapy and potentially also combinations in the GNAQ/11 hotspot mutation basket trial, in non-MUM indications such as skin melanoma."

    IDEAYA anticipates interim data from the MEK combination study in late 2021 to early 2022, at which time the company will evaluate a potential registrational path for MUM and a potential partnership. 

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine company committed to the discovery and development of Synthetic Lethality-based therapeutics for patient populations selected using molecular diagnostics.  IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including 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 results of combinations of IDE196 and other agents in both the MUM indication and non-MUM indications and (ii) the timing of interim data from the MEK combination study. 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 recent Quarterly Report on Form 10-Q filed on May 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-doses-first-patient-in-a-phase-1-combination-study-of-ide196-and-binimetinib-a-mek-inhibitor-301090539.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  39. SOUTH SAN FRANCISCO, Calif., June 30, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics based on Synthetic Lethality, announced the appointment of Garret Hampton, Ph.D., to its Board of Directors.  

    Dr. Hampton brings over 25 years of industry experience and currently serves as President, Clinical Sequencing and Oncology at Thermo Fisher Scientific.  He previously served as Senior Vice President, Clinical Genomics at Illumina.  Prior to Ilumina, Dr. Hampton was the Global Head of Oncology Biomarker Development and Companion Diagnostics at Genentech / Roche and chair of the Roche / Foundation Medicine Joint R&D Committee. Through these roles, Dr. Hampton has become a thought leader in the area of precision medicine oncology, including next generation sequencing, cancer genomics, and companion diagnostics. 

    "Garret brings deep industry experience from translational research, biomarker discovery and validation to approved companion diagnostics, and this wealth of knowledge will be invaluable to IDEAYA as it advances its broad pipeline of Synthetic Lethality programs into the clinic, each with a molecularly-defined biomarker hypothesis," said Tim Shannon, M.D., Chairman of IDEAYA's Board of Directors. 

    IDEAYA believes global access to molecular diagnostics for oncology patients, particularly in Asia, is key to the development of targeted oncology medicines.  The company continues to advance its Genomics Profiling Initiative (GPI) – leveraging various molecular platforms to identify patients that are most likely to benefit from the company's Synthetic Lethality programs, including MTAP-deletion which is present in approximately 15% of all solid tumors. 

    "Garret's expertise in the area of biomarker discovery and development will be instrumental as we advance our MAT2A Synthetic Lethality program into the clinic targeting the MTAP-deletion patient population, as well as pursue our broader global strategy to identify novel Synthetic Lethal targets and patient biomarkers," said Yujiro S. Hata, President and Chief Executive Officer, at IDEAYA. 

    "IDEAYA is a leader in Synthetic Lethality, an emerging field of precision medicine oncology.  Synthetic Lethality includes exciting new opportunities in translational research and biomarker discovery, all areas that are anticipated to flourish with the enhanced global access to next generation sequencing.  I'm delighted to join IDEAYA's Board of Directors as the company advances its broad pipeline of Synthetic Lethality based therapies, and pursues its mission to deliver transformative precision medicines to cancer patients," said Dr. Hampton.

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine company committed to the discovery and development of Synthetic Lethality-based therapeutics for patient populations selected using molecular diagnostics.  IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including 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 role of molecular diagnostics in the development of targeted oncology medicines and (ii) the effect of Dr. Hampton's expertise on IDEAYA's programs. 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 recent Quarterly Report on Form 10-Q filed on May 12, 2020, and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-appoints-garret-hampton-phd-to-the-board-of-directors-an-industry-leader-in-precision-medicine-oncology-and-diagnostics-301085509.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  40. SOUTH SAN FRANCISCO, Calif., June 17, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA) today announced the pricing of an underwritten public offering of 6,666,667 shares of its common stock at a public offering price of $15.00 per share, before underwriting discounts and commissions. In addition, IDEAYA has granted the underwriters a 30-day option to purchase up to an additional 1,000,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by IDEAYA, are expected to be $100.0 million excluding any exercise of the underwriters' option to purchase additional shares…

    SOUTH SAN FRANCISCO, Calif., June 17, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA) today announced the pricing of an underwritten public offering of 6,666,667 shares of its common stock at a public offering price of $15.00 per share, before underwriting discounts and commissions. In addition, IDEAYA has granted the underwriters a 30-day option to purchase up to an additional 1,000,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by IDEAYA, are expected to be $100.0 million excluding any exercise of the underwriters' option to purchase additional shares. The offering is expected to close on or about June 22, 2020, subject to the satisfaction of customary closing conditions.

    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) preclinical and clinical development of IDE397, its MAT2A inhibitor development candidate, and other product candidates in its research pipeline targeting poly (ADP-ribose) glycohydrolase, or PARG, and a DNA Damage Target, or DDT, as well as its share of costs for targeting WRN under the previously announced Collaboration, Option and License Agreement with GSK, (ii) ongoing early clinical development of IDE196, its PKC inhibitor, and binimetinib, a MEK inhibitor to which Pfizer has exclusive rights in the U.S. and Canada, as combination therapy in metastatic uveal melanoma, or MUM and other solid tumors having GNAQ/11 hotspot mutations, as well as ongoing clinical trials evaluating IDE196 as monotherapy in such indications, (iii) biomarker research and development activities and (iv) working capital and other general corporate purposes.

    J.P. Morgan, Citigroup and Jefferies are acting as joint book-running managers for the offering.  

    The securities described above are being offered 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 (the "SEC"). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, copies of which may be obtained, when available, 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; or 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.

    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 an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and 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 closing of the public offering and 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 12, 2020, the preliminary prospectus supplement related to the proposed public offering and subsequent filings with the SEC.

     

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-announces-pricing-of-public-offering-of-common-stock-301079211.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  41. SOUTH SAN FRANCISCO, Calif. and LONDON, June 16, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA) and GlaxoSmithKline plc (GSK) announce a strategic partnership in Synthetic Lethality, an emerging field in Oncology. 

    The strategic partnership includes IDEAYA's Synthetic Lethality programs MAT2A, Pol Theta, and Werner Helicase programs, which are projected to reach clinical trials within the next three years.  IDEAYA has solved the crystal structures for each of its MAT2A, Pol Theta and Werner Helicase programs, enabling structure-based drug design, and has demonstrated in vivo proof of concept in relevant animal models for its MAT2A and Pol Theta programs.  

    Synthetic Lethality is one of four core research focus areas for GSK in oncology. In synthetic lethality, cells tolerate the loss of single genes in isolation but not together in combination. When tumor suppressor genes are functionally lost in cancer, this mode of action can be used to exploit tumor-specific vulnerabilities through new medicines for patients with cancer.

    "GSK is the ideal strategic partner for IDEAYA, as this partnership enables compelling potential combinations and the opportunity to build the industry leading Synthetic Lethality pipeline that targets molecularly defined populations in several major solid tumors, including potentially lung, prostate, breast, colorectal, and ovarian cancer," said Yujiro S. Hata, Chief Executive Officer and President, IDEAYA Biosciences.

    IDEAYA will lead the MAT2A program through early clinical development.  IDEAYA is responsible for all costs of the MAT2A program prior to the GSK option exercise.  Thereafter, IDEAYA is responsible for 20% of global development costs.

    IDEAYA will receive a 50% US profit share and ex-US royalties for the MAT2A and Werner Helicase programs and is responsible for 20% of global development costs for licensed products being developed with GSK.  IDEAYA will receive global royalties for the Pol Theta program, and GSK will cover all research, development, and commercialization costs. GSK will be responsible for all commercialization activities and costs globally for licensed products. The collaboration agreement is conditional upon customary conditions including regulatory review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.

    "GSK and IDEAYA have a vision to bring the next generation of innovative precision medicine therapies to patients utilizing the approach of Synthetic Lethality, and a highly complementary pipeline that has the potential to deliver transformative benefit for patients," said Michael Dillon, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.

    IDEAYA Conference Call

    At 5:00 a.m. Pacific Time / 8:00 a.m. Eastern Time today, IDEAYA's management will host a conference call and a simultaneous webcast presentation to discuss the transaction.  The webcast presentation call can be accessed during the call by visiting the "Investors / News and Events / Presentation" section of IDEAYA's website at www.ideayabio.com. Please connect to the website prior to the start of the call to allow adequate time for any software download that may be required. A replay of the webcast will be available through approximately fourteen days following the live presentation webcast.

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and synthetic lethality – which represents an emerging class of precision medicine targets. 

    About GSK in Oncology

    GSK is focused on maximising patient survival through transformational medicines. GSK's pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

    About GSK

    GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to (i) the potential for cash payments related to MAT2A program option exercise and preclinical, clinical and sales milestones, (ii) the potential clinical combination of IDEAYA and GSK programs, (iii) the timing of IDEAYA's Synthetic Lethality programs reaching clinical trials, (iv) the potential for an industry leading pipeline and potential solid tumor types to be addressed, and (v) the ability to deliver transformative value to patients. 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 including Hart Scott Rodino Antitrust Improvements Act clearance, 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 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    Cautionary statement regarding forward-looking statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and any impacts of the COVID-19 pandemic.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS

    Investor and Media Contact

    IDEAYA Biosciences

    Paul Stone

    Chief Financial Officer

    investor@ideayabio.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-and-gsk-announce-a-broad-partnership-in-synthetic-lethality-an-emerging-field-in-precision-medicine-oncology-301077366.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  42. SOUTH SAN FRANCISCO, Calif., June 11, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA) is an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics.  The Company announced that it has been selected to join the broad-market Russell 3000® Index, according to preliminary list of additions posted by FTSE Russell on June 5, 2020.  IDEAYA's inclusion in the Russell 3000® Index is anticipated to be effective at the conclusion of the 2020 Russell indexes annual reconstitution, effective after US market opening on June 29, 2020.

    "We are pleased to be included in the Russel 3000® Index, signifying our growth as a public company.  IDEAYA is committed to discovering and developing innovative precision medicines based on synthetic lethality, an emerging field of precision oncology," said Paul Stone, J.D., Chief Financial Officer of IDEAYA.

    Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies.  Annual Russell indexes reconstitution captures the 4,000 largest US stocks as of May 8, 2020, ranking them by total market capitalization. Membership in the US all-cap Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000Ò Index or small-cap Russell 2000Ò Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.  For more information on the Russell 3000® Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and 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 the anticipated timing of inclusion in the Russell 3000® Index. 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 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-selected-to-join-russell-3000-index-301074086.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  43. SOUTH SAN FRANCISCO, Calif., June 8, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics, announced that it has selected development candidate, IDE397, for its Methionine adenosyltransferase 2a (MAT2A) Synthetic Lethality program.  The MAT2A program targets patients with tumors having methylthioadenosine phosphorylase (MTAP) deletions. With the nomination of IDE397 as a development candidate for the MAT2A program, IDEAYA has initiated IND-enabling studies and is targeting filing the Investigational New Drug (IND) application in the fourth quarter 2020.

    SOUTH SAN FRANCISCO, Calif., June 8, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics, announced that it has selected development candidate, IDE397, for its Methionine adenosyltransferase 2a (MAT2A) Synthetic Lethality program.  The MAT2A program targets patients with tumors having methylthioadenosine phosphorylase (MTAP) deletions. With the nomination of IDE397 as a development candidate for the MAT2A program, IDEAYA has initiated IND-enabling studies and is targeting filing the Investigational New Drug (IND) application in the fourth quarter 2020.

    "With IDE397, we have achieved our preclinical target product profile of a differentiated compound, including potency, safety assessment, and physicochemical property characteristics.  Based on the preclinical in vivo efficacy data we have generated, we believe IDE397 has the potential for evaluation in both monotherapy and combination studies in select solid tumor types with the genetic alteration of MTAP-deletion," said Michael Dillon, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.

    IDE397 Product Profile and MAT2A Program Summary:

    • Monotherapy activity with robust tumor growth inhibition and pharmacodynamic (PD) modulation in multiple endogenous MTAP-/- in vivo models
    • Monotherapy activity and tumor regression in HCT116 MTAP-/- xenograft model
    • No changes in liver enzymes or increased unconjugated bilirubin levels observed in preclinical studies
    • Favorable physicochemical properties and pharmacokinetics observed across multiple species
    • MAT2A program enabled by structure-based drug design; over 17 high resolution co-crystal structures have been resolved to enable lead optimization

    About MAT2A and MTAP-Deletion:

    MTAP-null cells lack the ability to metabolize 5-methylthioadenosine, or MTA, which is an essential step in a biochemical pathway involved in salvaging metabolite S-adenosyl methionine, or SAM. Increased levels of MTA partially inhibit the methyltransferase PRMT5 for which SAM is the substrate. This partial inhibition renders MTAP-null cells more dependent on the activity of methionine adenosyltransferase II alpha or MAT2A, an enzyme that is responsible for the synthesis of SAM. Because of this dependence, loss of MTAP results in synthetic lethality when MAT2A is pharmacologically inhibited.

    MTAP deletions are prevalent in approximately 15% of all human tumors across various tumor types. Genetic profiling tests for the deletion of MTAP or for the commonly co-deleted gene CDKN2A are commercially available.

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and 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) timing of filing of an IND for IDE397 and (ii) the potential for evaluation in both monotherapy and combination studies. 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 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-announces-nomination-of-development-candidate-ide397-for-mat2a-synthetic-lethality-program-targeting-mtap-deletion-patient-population-301071598.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  44. SOUTH SAN FRANCISCO, Calif., May 19, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics, announced that Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences, is scheduled to participate in a fireside chat discussion hosted by Maury Raycroft, Ph.D.,  Equity Analyst, at the Jefferies Virtual Healthcare Conference on Tues, June 2, 2020 at 11:00 a.m. ET (8:00 am PT). 

    ___________________

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and 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 recent Quarterly Report on Form 10-Q filed on May 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    ___________________

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-to-participate-in-jefferies-virtual-healthcare-conference-on-tuesday-june-2-2020-301061319.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  45. SOUTH SAN FRANCISCO, Calif., May 15, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA) is an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics.  The company announced publication today of abstracts at the 2020 Annual Meeting of the American Association for Cancer Research (AACR).

    The IDEAYA abstracts were posted online by AACR (http://www.aacr.org) in advance of the AACR Virtual Annual Meeting II, which will be held on June 22-24, 2020:

    • Title: "Analysis of drug combinations with the PKC inhibitor IDE196 support dual MEK and PKC inhibition as a rational combination in metastatic uveal melanoma" (Author: Christian Frey)
    • Title: "MAT2A Inhibitors decrease growth, increase senescence and p53 stability in MTAP-deleted cancer cells" (Author: Neil Bhola)
    • Title: "In vitro and in vivo characterization of novel MAT2A allosteric inhibitors" (Author: Zhonghua Pei)

    IDE196 is a potent and selective protein kinase C (PKC) inhibitor being evaluated in an ongoing Phase 1/2 tumor-agnostic clinical trial in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) hotspot mutations.  IDEAYA is currently enrolling into a Phase 2 monotherapy expansion arm for patients with such GNAQ/11 mutant tumors, including Cutaneous Melanoma, and recently completed enrollment into a Phase 1 monotherapy arm for patients with Metastatic Uveal Melanoma.  IDEAYA is preparing to evaluate the clinical combination of IDE196 and binimetinib, a MEK inhibitor, in a combination arm initiating in mid-2020 for patients with such GNAQ/11 hotspot mutations.

    "We believe that IDE196 presents multiple opportunities for being impactful for patients and creating value.  The preclinical combination data with IDE196 and MEK inhibitor being presented at AACR helps guide our clinical development strategy, and demonstrates our commitment to validating these opportunities," said Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences.   

    IDEAYA's most advanced synthetic lethality program is targeting methionine adenosyltransferase II alpha (MAT2A). IDEAYA plans to develop a MAT2A inhibitor for patients having solid tumors with methylthioadenosine phosphorylase (MTAP) gene deletion, which occurs in approximately 15% of all solid tumors.  MTAP-null tumor cells have been shown to be more dependent on the activity of MAT2A, resulting in synthetic lethality when MAT2A is pharmacologically inhibited.

    "We are building a leading company in synthetic lethality – an emerging area of precision medicine oncology, with active ongoing research across multiple targets, including MAT2A, Pol theta, Werner helicase and PARG.  Our MAT2A program presents a potential opportunity to be best in class in the molecularly-defined patient population of MTAP-deletion.  We recently selected a differentiated MAT2A inhibitor lead compound and are on track for an IND submission to the FDA in the fourth quarter of 2020.  We look forward to sharing additional data on this molecule as we advance this program," said Dr. Michael Dillon, Ph.D., Senior Vice President, Chief Scientific Officer and Head of Research at IDEAYA Biosciences.

    About IDEAYA Biosciences
    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and 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 the initiation of a combination clinical trial of IDE196 and binimetinib, (ii) our ability to develop a successful MAT2A inhibitor, (iii) our ability to build a leading company in synthetic lethality, and (iv) timing of filing of an IND for a MAT2A inhibitor. 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 our 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 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-announces-aacr-abstracts-for-ide196-targeting-gnaq11-tumors-and-preclinical-mat2a-synthetic-lethality-program-301059878.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  46. SOUTH SAN FRANCISCO, Calif., May 12, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics, provided a business update and announced financial results for the first quarter ended March 31, 2020.

    "IDEAYA continues to advance development of IDE196 in our Phase 1/2 tissue-agnostic basket trial in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11).  We are generally not experiencing substantial impact from the COVID-19 pandemic on our IDE196 clinical program.  We have completed enrollment of patients in the metastatic uveal melanoma (MUM) Phase 1 portion of the clinical trial and are continuing enrollment of GNAQ/11 patients with other solid tumors, such as cutaneous melanoma and colorectal cancer, in an ongoing Phase 2 portion of the clinical trial.  We also remain on track for initiating a new cohort in this clinical trial to evaluate IDE196 in combination with binimetinib under a clinical trial collaboration and supply agreement with Pfizer," said Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences.

    IDEAYA is also advancing its MAT2A program for patients having tumors with MTAP deletion.  The company has selected a lead compound MAT2A inhibitor, and remains on track to file an IND for a differentiated and potential best-in-class MAT2A inhibitor development candidate in the fourth quarter of 2020. 

    IDEAYA's broad pipeline of synthetic lethality programs also includes Pol theta for tumors with BRCA or other homologous recombination deficiency (HRD) mutations, Werner helicase (WRN) for tumors with high microsatellite instability (MSI), and PARG for tumors with BRCA2 mutations, impaired base excision repair, or replication stress signature.  The company is also advancing early discovery efforts on multiple undisclosed synthetic lethality targets.

    Key highlights for IDEAYA's research and development programs include:

    Clinical IDE196 Program

    IDE196

    Continued to execute on IDEAYA's Phase 1/2 tissue-type agnostic basket trial, initiated in June 2019, to evaluate IDE196 in solid tumors harboring activating GNAQ/11 mutations, entitled "A phase 1/2 study of IDE196 in patients with solid tumors harboring GNAQ/11 mutations or PRKC fusions" (ClinicalTrials.gov Identifier: NCT03947385). As of May 1, 2020, unless otherwise noted:

    • Enrolled 56 patients in IDE196 monotherapy arm of Phase 1/2 clinical trial
      • Completed enrollment and ongoing evaluation of IDE196 in the MUM monotherapy arm, with aggregate enrollment of 51 patients in the Phase 1 dose escalation and tablet formulation studies
      • Ongoing enrollment into the Phase 2 expansion arm for IDE196 as a monotherapy in solid tumors other than MUM having GNAQ or GNA11 hotspot mutations, with aggregate Phase 1/2 enrollment of 5 cutaneous melanoma patients
      • Completed evaluation of the tablet formulation of IDE196 in MUM patients in a Phase 1 sub-study, with the pharmacokinetic profile of the tablet formulation comparable to the powder-in-capsule form of IDE196
      • Completed in-life portion of the ongoing 13-week GLP-compliant toxicology studies in two species, initiated in November 2019
      • Interim data from the monotherapy arm of the Phase 1/2 basket trial on track for fourth quarter of 2020
    • COVID-19 pandemic is not currently having a substantial impact, generally, on the ongoing IDE196 clinical program
      • GNAQ/11 patients enrolled in the ongoing Phase 1/2 clinical trial and sites affected by COVID-19 restrictions are adapting to logistical constraints on activities, such as travel and site visits
      • Patients are continuing on IDE196 therapy, which is an oral drug and is being shipped to and self-administered by patients at home
      • Patients are being monitored through a combination of telemedicine visits and local visits
      • Enrollment into the Phase 2 expansion arm for IDE196 as a monotherapy in non-MUM solid tumors having GNAQ or GNA11 hotspot mutations may be delayed by circumstances resulting from the COVID-19 pandemic. The specific impact is currently uncertain; two of four active sites for this arm of the clinical trial are continuing enrollment activities; the other two sites have suspended enrollment due to COVID-19.
    • Preparing and on track for initiation of combination arm of the IDE196 Phase 1/2 clinical trial in mid-2020 to evaluate safety and efficacy of IDE196 in combination with binimetinib, a MEK inhibitor, in patients having tumors with activating GNAQ or GNA11 hotspot mutations, including in metastatic uveal melanoma and other solid tumors
      • Established Joint Development Committee with Pfizer to facilitate collaboration for combination arm drug supply, trial initiation and ongoing development
      • Coordinating with clinical trial sites to prepare for combination arm initiation
      • Preparation for combination arm of the clinical trial not currently substantially impacted by COVID-19

    Preclinical Synthetic Lethality Programs

    MAT2A

    • Continuing preclinical development efforts of selected lead compound believed to favorably differentiate in vivo activity, physical properties and tolerability profile relative to published Agios compounds
    • On track to select a development candidate in the second quarter of 2020
    • Anticipate filing an IND for MAT2A inhibitor development candidate in fourth quarter of 2020

    Pol Theta

    • Targeting designation of Pol-theta inhibitor development candidate in second half of 2020

    PARG

    • Demonstrated in vivo proof of concept in a relevant animal model having a replication stress genetic signature

    WRN

    • Targeting to demonstrate in vivo proof of concept in relevant animal models in 2020

    Corporate Updates

    IDEAYA anticipates that existing cash, cash equivalents, and short-term and long-term marketable securities of $90.9 million (as of March 31, 2020) will be sufficient to fund planned operations into the end of 2021 to early 2022. 

    Our updated corporate presentation is available on our website, in the Presentations section of our Investor Relations page. See: https://ir.ideayabio.com/news-events/presentations.

    Financial Results

    As of March 31, 2020, IDEAYA had cash, cash equivalents, and short-term and long-term marketable securities totaling $90.9 million. This compared to cash, cash equivalents and short-term marketable securities of $100.5 million at December 31, 2019. The decrease was primarily due to cash used in operations. 

    Research and development expenses for the three months ended March 31, 2020 totaled $9.0 million compared to $8.0 million for the same period in 2019. The increase was primarily due to an increase in fees to CROs and CMOs as well as fees to contractors related to support costs for our Phase 1/2 clinical trial to evaluate IDE196 in solid tumors and the advancement of our lead product candidates through preclinical studies.

    General and administrative expenses for the three months ended March 31, 2020 totaled $3.5 million compared to $2.1 million for the same period in 2019. The increase was primarily due to an increase in payroll expenses, including salaries, benefits and stock-based compensation expense related to increased general and administrative headcount to support our growth as a public company, and an increase in director and officer insurance policy premiums as a public company.

    The net loss for the three months ended March 31, 2020 was $12.0 million compared to $9.6 million for the same period in 2019. Total stock compensation expense for the three months ended March 31, 2020 was $0.8 million compared to $0.4 million for the same period in 2019.

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and 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) timing of release of interim monotherapy data for the IDE196 Phase 1/2 basket trial, (ii) timing of the initiation of a combination clinical trial of IDE196 and binimetinib, (iii) timing of selection of a development candidate and filing of an IND for a MAT2A inhibitor, (iv) timing of selection of a Pol-theta inhibitor development candidate, (v) timing for WRN demonstration of in vivo proof of concept in relevant animal models, and (vi) the extent to which IDEAYA's existing cash, cash equivalents, and short-term and long-term 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 May 12, 2020 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

    Mar 31,




    2020



    2019


    Operating expenses









    Research and development


    $

    9,026



    $

    7,996


    General and administrative



    3,452




    2,098


    Total operating expenses



    12,478




    10,094


    Loss from operations



    (12,478)




    (10,094)


    Interest income and other income (expense), net



    435




    525


    Net loss


    $

    (12,043)



    $

    (9,569)


    Change in unrealized gains (losses) on marketable securities



    (65)




    39


    Comprehensive loss


    $

    (12,108)



    $

    (9,530)


    Net loss per share attributable to common stockholders, basic and diluted


    $

    (0.59)



    $

    (8.69)


    Weighted average number of shares outstanding, basic and diluted



    20,250,549




    1,101,107


     

    IDEAYA Biosciences, Inc.

    Condensed Balance Sheet Data

    (in thousands, except share and per share amounts)




    March 31,



    December 31,




    2020



    2019


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


    $

    90,903



    $

    100,482


    Total assets



    101,791




    113,001


    Total liabilities



    12,688




    12,601


    Total liabilities and stockholders' equity



    101,791




    113,001


     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-inc-reports-first-quarter-2020-financial-results-and-provides-business-update-301057256.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  47. SOUTH SAN FRANCISCO, Calif., April 21, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics, announced that Julie Patel has joined the company as Vice President, Human Resources.  Ms. Patel will join the IDEAYA leadership team and will have broad functional responsibilities for human resources within the company.    

    "We are thrilled to have Julie join our leadership team at IDEAYA.  Julie has extensive experience as a human resources professional at world-class biopharmaceutical companies.  Her leadership will guide our efforts to enhance our team as we continue to expand our capabilities and advance our programs – toward our goal of building a leading synthetic lethality biopharmaceutical company," said Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences.

    Ms. Patel previously served as a human resources leader in various life science companies.  Most recently at Jazz Pharmaceuticals, she was Senior Director, HR Business Partners for US Commercial, Legal and Compliance, and held several earlier roles, including as Director, Global Leadership and Development.  Prior to Jazz, Ms. Patel was Senior Director, Strategic HR, Global Development at Elan Pharmaceuticals.  Ms. Patel also worked earlier in her career at Johnson & Johnson companies, Scios and ALZA, and at an Eli Lilly company, IVAC.

    "I am ecstatic to join the IDEAYA team, and to support its efforts to build a leading precision medicine oncology company.  The company's programs enable a unique opportunity to pursue its vision of improving patients' lives through transformative precision medicines," said Ms. Patel.

    About IDEAYA Biosciences
    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and 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 enhancement of our team, advancement of our programs, and ability to build a leading synthetic lethality biopharmaceutical company. 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 our 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 Annual Report on Form 10-K filed on March 24, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-announces-addition-of-julie-patel-as-vice-president-human-resources-enhancing-its-leadership-team-301043781.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  48. SOUTH SAN FRANCISCO, Calif., March 24, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics, provided a business update and announced financial results for the fourth quarter ended December 31, 2019.

    "IDEAYA is building a leading synthetic lethality biopharmaceutical company, advancing a broad pipeline of synthetic lethality programs, including our MAT2A program for which we have selected a lead compound MAT2A inhibitor.   We also continue to advance development of IDE196 in our Phase 1/2 tissue-agnostic basket trial in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations such as metastatic uveal melanoma (MUM), cutaneous melanoma and colorectal cancer, including evaluation of IDE196 in combination with binimetinib under a clinical trial collaboration and supply agreement with Pfizer," said Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences.

    We continue to progress our MAT2A synthetic lethality program for tumors with MTAP deletion.  We have selected a lead compound which we believe has favorably differentiated activity, physical properties and tolerability, and have scaled this lead compound for non-GLP toxicology studies in two species to support selection of a development candidate in the second quarter of 2020. 

    We also continue to progress our broad pipeline of synthetic lethality programs, including Pol theta for tumors with BRCA or other homologous recombination deficiency (HRD) mutations, Werner (WRN) for tumors with high microsatellite instability (MSI), and PARG for  tumors with BRCA2 mutations, impaired base excision repair, or replication stress signature.  We are applying our fully integrated research and translational capabilities to these programs.  We have solved the crystal structures for each of these research programs, and we are conducting preclinical in vivo efficacy studies in three of our synthetic lethality programs.

    Key highlights for IDEAYA's research and development programs include:

    Clinical Program IDE196

    IDE196

    • Advanced IDEAYA's Phase 1/2 tissue-type agnostic basket trial, initiated in June 2019, to evaluate IDE196 in solid tumors harboring activating GNAQ/11 mutations, entitled "A phase 1/2 study of IDE196 in patients with solid tumors harboring GNAQ/11 mutations or PRKC fusions" (ClinicalTrials.gov Identifier: NCT03947385). As of March 15, 2020:
      • Enrolled 53 patients in IDE196 monotherapy arm of Phase 1/2 clinical trial
      • Ongoing evaluation of IDE196 monotherapy arm in MUM, with aggregate enrollment of 49 patients in the Phase 1 dose escalation and tablet formulation studies
      • Initiated the Phase 2 expansion for IDE196 as a monotherapy in solid tumors other than MUM having GNAQ or GNA11 hotspot mutations, with aggregate Phase 1/2 enrollment of 4 cutaneous melanoma patients
      • Selected 400mg BID (with one week 200 mg BID run-in) as Phase 2 monotherapy dose; observed higher average steady state exposure of free IDE196 (AUCfree, increase of approximately 44%) and higher trough concentration of IDE196 (Cmin, increase of approximately 40%) at 400 mg BID relative to 300 mg BID dose
      • Evaluating tablet formulation of IDE196 in MUM patients in a Phase 1 sub-study, with the pharmacokinetic profile of the tablet formulation comparable to the powder-in-capsule form of IDE196
      • Completed in-life portion of the ongoing 13-week GLP-compliant toxicology studies in two species, initiated in November 2019
      • Interim data from the monotherapy arm of the Phase 1/2 basket trial targeted for second half 2020
      • Entered into a clinical trial collaboration and supply agreement with Pfizer; targeting to initiate combination arm of Phase 1/2 clinical trial in mid-2020 to evaluate safety and efficacy of IDE196 in combination with binimetinib, a MEK inhibitor, in patients having tumors with activating GNAQ or GNA11 hotspot mutations, including in metastatic uveal melanoma and other solid tumors
      • Design and initiation of potential registration-enabling study in MUM will be evaluated based on results of ongoing IDE196 monotherapy arm and planned IDE196 / binimetinib combination arm of the Phase 1/2 clinical trial

    Preclinical Synthetic Lethality Programs

    MAT2A

    • Observed single agent in vivo efficacy of our MAT2A inhibitors, including tumor growth inhibition or tumor regression in multiple MTAP -/- endogenous models
    • Selected a lead compound which we believe has favorably differentiated in vivo activity, physical properties and tolerability profile relative to published Agios compounds
    • Scaled the MAT2A lead compound for non-GLP toxicology studies in two species to support selection of a development candidate in the second quarter of 2020
    • Expect to file an IND for MAT2A inhibitor development candidate in fourth quarter of 2020

    Pol Theta

    • Observed monotherapy activity, showing cell viability activity and in vivo tumor growth inhibition in a DLD1 BRCA2 -/- engineered model
    • Observed combination activity with a PARPi, Olaparib, as well as synergistic cell viability activity and synergistic in vivo tumor growth inhibition in the DLD1 BRCA2 -/- engineered model, with a weak drug-drug interaction signal
    • Targeting designation of Pol-theta inhibitor development candidate in second half of 2020

    Werner (WRN)

    • Observed dose-dependent cellular viability effect in multiple endogenous MSI high cell lines, with an expected lack of activity in microsatellite stable, or MSS, cell lines
    • Observed dose-dependent cellular pharmacodynamic (PD) response in multiple endogenous MSI high cell lines
    • Solved crystal structure of WRN helicase domain
    • Targeting to demonstrate in vivo proof of concept in relevant animal models in 2020

    PARG

    • Observed dose-dependent cellular pharmacodynamic response and cellular viability effect in a HCC1806 XRCC1 -/- cell line
    • Expanded research collaboration with Cancer Research UK (CRUK) and the University of Manchester, UK, to evaluate IDEAYA's potent selective PARG inhibitors in vitro and in vivo in multiple ovarian cancer cell lines and xenograft models, respectively, and to evaluate replication stress signature as a potential patient selection biomarker

    "We continue to advance our programs, expand our capabilities and enhance our team.  We believe that the IDE196 clinical program and our preclinical pipeline of synthetic lethality programs are maturing, moving forward toward our goal of improving lives through transformative precision medicines," said Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences. 

    Corporate Updates

    IDEAYA anticipates that existing cash, cash equivalents, and short-term and long-term marketable securities of $100.5 million (as of December 31, 2019) will be sufficient to fund planned operations into the end of 2021 to early 2022. 

    Our updated corporate presentation is available on our website, in the Presentations section of our Investor Relations page. See: https://ir.ideayabio.com/news-events/presentations.

    Financial Results

    As of December 31, 2019, IDEAYA had cash, cash equivalents, and short-term and long-term marketable securities totaling $100.5 million. This compared to cash, cash equivalents and short-term marketable securities of $90.0 million at December 31, 2018. The increase was primarily due to the receipt of $50.2 million in net proceeds from IDEAYA's initial public offering, which was completed in May 2019, offset by cash used in operations.

    Research and development expenses for the three months ended December 31, 2019 totaled $8.5 million compared to $7.6 million for the same period in 2018. The increase was primarily due to costs in connection with IDEAYA's Phase 1/2 clinical trial to evaluate IDE196 in solid tumors, and costs for personnel and consulting in support of our research programs during the three months ended December 31, 2019.

    General and administrative expenses for the three months ended December 31, 2019 totaled $2.8 million compared to $1.6 million for the same period in 2018. The increase was primarily due to an increase in costs for personnel and directors' and officers' liability insurance premiums in connection with becoming a publicly traded company.

    Research and development expenses for the year ended December 31, 2019 totaled $34.3 million compared to $31.7 million for 2018. The increase was primarily due to an increase in costs in connection with IDEAYA's Phase 1/2 clinical trial to evaluate IDE196 in solid tumors, and costs for personnel and consulting in support of our research programs during the year ended December 31, 2019, offset by a decrease in license fees for our IDE196 license agreement with Novartis during the year ended December 31, 2018.

    General and administrative expenses for the year ended December 31, 2019 totaled $10.0 million compared to $4.7 million for 2018. The increase was primarily due to an increase in costs for personnel, directors' and officers' liability insurance premiums, and professional fees in connection with becoming a publicly traded company.

    The net loss for the three months ended December 31, 2019 was $10.8 million compared to $8.6 million for the same period in 2018. Total stock compensation expense for the three months ended December 31, 2019 was $0.7 million compared to $0.3 million for the same period in 2018.

    The net loss for the year ended December 31, 2019 was $42.0 million compared to $34.3 million for the same period in 2018. Total stock compensation expense for the year ended December 31, 2019 was $2.2 million compared to $1.0 million for the same period in 2018.

    About IDEAYA Biosciences

    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and 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) timing of release of interim monotherapy data for the IDE196 Phase 1/2 basket trial, (ii) timing of the initiation of a combination clinical trial of IDE196 and binimetinib, (iii) timing of evaluation of initiation and design of potential registration-enabling study in MUM, (iv) timing of selection of a development candidate and filing of an IND for a MAT2A inhibitor, (v) timing of selection of a Pol-theta inhibitor development candidate, (vi) timing for WRN demonstration of in vivo proof of concept in relevant animal models, and (vii) the extent to which IDEAYA's existing cash, cash equivalents, and short-term and long-term 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 our 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 Annual Report on Form 10-K filed on March 24, 2020 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

    December 31,



    Year Ended

    December 31,



    2019



    2018



    2019



    2018


    Operating expenses
















    Research and development

    $

    8,541



    $

    7,577



    $

    34,319



    $

    31,749


    General and administrative


    2,778




    1,556




    9,952




    4,668


    Total operating expenses


    11,319




    9,133




    44,271




    36,417


    Loss from operations


    (11,319)




    (9,133)




    (44,271)




    (36,417)


    Interest income


    536




    571




    2,288




    1,994


    Other income (expense), net


    2







    8




    77


    Net loss

    $

    (10,781)



    $

    (8,562)



    $

    (41,975)



    $

    (34,346)


    Change in unrealized gains (losses) on marketable securities


    (13)




    (14)




    96




    (30)


    Comprehensive loss

    $

    (10,794)



    $

    (8,576)



    $

    (41,879)



    $

    (34,376)


    Net loss per share attributable to common stockholders, basic and diluted

    $

    (0.53)



    $

    (8.11)



    $

    (3.36)



    $

    (35.92)


    Weighted average number of shares outstanding, basic and diluted


    20,216,275




    1,055,131




    12,496,957




    956,252


     

    IDEAYA Biosciences, Inc.

    Condensed Balance Sheet Data

    (in thousands, except share and per share amounts)




    December 31,



    December 31,




    2019



    2018


    Cash and cash equivalents and marketable securities


    $

    100,482



    $

    89,961


    Total assets



    113,001




    96,541


    Total liabilities



    12,601




    7,098


    Total liabilities, redeemable convertible preferred stock and stockholders' equity



    113,001




    96,541


     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ideaya-biosciences-inc-reports-fourth-quarter-2019-financial-results-and-provides-business-update-301028643.html

    SOURCE IDEAYA Biosciences, Inc.

    View Full Article Hide Full Article
  49. SOUTH SAN FRANCISCO, Calif., March 18, 2020 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, announces an update for IDE196, a Protein Kinase C (PKC) inhibitor, in its ongoing Phase 1/2 clinical trial entitled "A Phase 1/2 Study in Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions" (ClinicalTrials.gov Identifier: NCT03947385). 

    IDEAYA is pursuing both a monotherapy and combination approach for IDE196 in Metastatic Uveal Melanoma and GNAQ/GNA11 hotspot mutation solid tumors, including Cutaneous Melanoma and Colorectal Cancer.  The company selected a Phase 2 monotherapy dose of 400mg BID (with one-week 200mg BID run-in) and achieved first-patient-in (FPI) for the GNAQ/GNA11 non-MUM basket trial.  IDEAYA also announced plans to evaluate the clinical combination of IDE196 and binimetinib, a MEK inhibitor.  IDEAYA anticipates initiating this clinical combination in mid-2020 as part of its ongoing Phase 1/2 clinical trial. 

    Key IDE196 program updates as of March 15, 2020 include:

    • 53 patients enrolled in Phase 1/2 monotherapy study, including 49 in MUM and 4 in Cutaneous Melanoma, from earlier-reported 40 patients in December 2019
    • Selected 400mg BID (with one-week 200 mg BID run-in) as Phase 2 monotherapy dose; observed approximately 44% higher average steady state exposure of free IDE196 (AUCfree) and approximately 40% higher trough concentration of IDE196 (Cmin) at the higher 400 mg BID run-in dose relative to the 300 mg BID dose
    • Initiated Phase 2 monotherapy expansion for GNAQ/GNA11 non-MUM basket trial
    • Phase 1 sub-study evaluation of pharmacokinetic profile for tablet formulation demonstrates targeted equivalence of pharmacokinetic properties with powder-in-capsule (PIC) formulation; 11 MUM patients dosed with the tablet formulation
    • Targeting initiation of IDE196 and binimetinib combination clinical trial in mid-2020
    • Interim data from IDE196 monotherapy Phase 1/2 clinical study targeted for second half of 2020
    • Design and initiation of potential registration-enabling study in MUM will be evaluated based on results of the ongoing Phase 1/2 monotherapy arm and the IDE196 and binimetinib combination arm of the clinical trial, at which time we will provide guidance on potential NDA timing
    • Cash currently anticipated to be sufficient to fund planned operations into end of 2021 to early 2022, which is an extension from the earlier guided third quarter 2021

    "We continue to see robust enrollment of MUM patients in our Phase 1/2 monotherapy study and look forward to providing the interim data update in the second half of 2020," said Julie Hambleton, M.D., Chief Medical Officer and Senior Vice President at IDEAYA Biosciences.  "We have made significant progress in the IDE196 clinical program, including selecting the Phase 2 monotherapy dose, initiating Phase 2 monotherapy expansion for the basket trial for non-MUM patients, and introducing the tablet formulation.  In addition, we plan to evaluate a combination strategy targeting multiple nodes of the MAP-Kinase pathway, which we believe may inform the optimal registrational path for MUM." 

    About IDEAYA Biosciences
    IDEAYA is an oncology-focused precision medicine 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 small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.  IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and 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) initiation of a combination clinical trial of IDE196 plus a MEK inhibitor in mid-2020, (ii) timing of release of interim monotherapy data for the IDE196 Phase 1/2 basket trial, (iii) timing of evaluation of initiation and design of potential registration-enabling study in MUM, and (iv) sufficiency of cash to fund planned operations into the end of 2021 or early 2022.  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