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IDEAYA Biosciences, Inc. Reports Third Quarter 2019 Financial Results and Provides Business Update


SOUTH SAN FRANCISCO, Calif., Nov. 13, 2019 /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 third quarter ended September 30, 2019.

(PRNewsfoto/IDEAYA Biosciences, Inc.)

"We have made significant progress on our Phase 1/2 tissue-agnostic basket trial evaluating IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations, including metastatic uveal melanoma (MUM), cutaneous melanoma and colorectal cancer.  This clinical trial progress, considered together with recent FDA feedback providing guidance on the regulatory pathway for IDE196 for treatment of MUM, are important enabling steps to advance this clinical-stage program," said Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences.

IDEAYA continues to advance its MAT2A synthetic lethality program to treat patients having tumors with MTAP deletion.  The Company remains committed to the research and development of a differentiated MAT2A inhibitor that could meaningfully enhance patient outcomes across a broad range of indications.  IDEAYA also continues to progress its broad pipeline of synthetic lethality programs, including Pol theta for patients having tumors with BRCA or other homologous recombination deficiency (HRD) mutations, and Werner (WRN) for patients having tumors with high microsatellite instability (MSI). 

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

Clinical Program IDE196

IDE196

Synthetic Lethality Preclinical Pipeline

MAT2A

"We continue to aggressively progress our programs, expand our capabilities and enhance our team.  IDEAYA remains committed to its vision of improving lives through transformative precision medicines, and believes that the IDE196 tissue-type agnostic basket trial and our pipeline of synthetic lethality programs are key elements of this goal," said Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences. 

Corporate Updates

IDEAYA anticipates that existing cash, cash equivalents and short-term marketable securities of $109.4 million (as of September 30, 2019) will be sufficient to fund planned operations into the third quarter of 2021. 

Financial Results

As of September 30, 2019, IDEAYA had cash, cash equivalents and short-term marketable securities totaling $109.4 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 September 30, 2019 totaled $8.9 million compared to $12.5 million for the same period in 2018. The decrease was primarily due to license fees for our IDE196 license agreement with Novartis during the three months ended September 30, 2018, offset by an increase in costs in connection with IDEAYA's Phase 1/2 clinical trial to evaluate IDE196 in solid tumors, and costs for personnel, consulting, and laboratory supplies in support of our research programs during the three months ended September 30, 2019.

General and administrative expenses for the three months ended September 30, 2019 totaled $2.7 million compared to $1.1 million for the same period in 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 as well as external legal patent expenses for our product candidates.

The net loss for the three months ended September 30, 2019 was $11.0 million compared to $13.0 million for the same period in 2018. Total stock compensation expense for the three months ended September 30, 2019 was $0.5 million compared to $0.3 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) expected timing for dose selection for and initiation of the Phase 2 portion of the IDE196 Phase 1/2 basket trial, introduction of a tablet formulation of IDE196, release of interim data for the IDE196 Phase 1/2 basket trial, initiation of the 13-week GLP-compliant toxicology studies for IDE196, submission of an NDA to the FDA for IDE196 in MUM, selection of a MAT2A inhibitor development candidate and filing of an IND for a MAT2A inhibitor development candidate and (ii) the extent to which IDEAYA's existing cash, cash equivalents and short-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 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 13, 2019 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)

(Unaudited)




Three Months Ended
September 30,



Nine Months Ended
September 30,




2019



2018



2019



2018


Operating expenses

















Research and development


$

8,923



$

12,538



$

25,778



$

24,172


General and administrative



2,700




1,088




7,174




3,112


Total operating expenses



11,623




13,626




32,952




27,284


Loss from operations



(11,623)




(13,626)




(32,952)




(27,284)


Interest income



654




573




1,752




1,423


Other income (expense), net



?




1




6




77


Net loss


$

(10,969)



$

(13,052)



$

(31,194)



$

(25,784)


Change in unrealized gains (losses) on marketable securities



41




16




109




(16)


Comprehensive loss


$

(10,928)



$

(13,036)



$

(31,085)



$

(25,800)


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


$

(0.54)



$

(13.06)



$

(3.15)



$

(27.94)


Weighted average number of shares outstanding, basic and diluted



20,158,223




999,369




9,895,574




922,664



















 

IDEAYA Biosciences, Inc.

Condensed Balance Sheet Data

(in thousands, except share and per share amounts)

 (Unaudited)




September 30,



December 31,




2019



2018 (1)


Cash and cash equivalents and short-term marketable securities


$

109,356



$

89,961


Total assets



122,331




96,541


Total liabilities



11,925




7,098


Total liabilities, redeemable convertible preferred stock and

    stockholders' equity



122,331




96,541




(1)

Derived from the audited financial statements for the year ended December 31, 2018, included in the Company's Prospectus filed pursuant to Rule 424(b)(4) under the Securities Act with the U.S. Securities and Exchange Commission on May 24, 2019.

 

 

SOURCE IDEAYA Biosciences, Inc.


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News published on 13 november 2019 at 06:00 and distributed by: