UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number:
(Exact name of registrant as specified in its charter)
|
||
(State or other jurisdiction of incorporation or organization) |
|
(I.R.S. Employer Identification No.) |
|
|
|
|
||
(Address of principal executive offices) |
|
(Zip Code) |
(
(telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
|
|
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
☒ |
|
|
Accelerated filer |
☐ |
|
Non-accelerated filer |
☐ |
|
|
Smaller reporting company |
|
|
|
|
|
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of August 2, 2024, the registrant had
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Form 10-Q, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated products, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this Quarterly Report on Form 10-Q are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions described under the sections in this Quarterly Report on Form 10-Q entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report on Form 10-Q. These forward-looking statements are subject to numerous risks, including, without limitation, the following:
1
Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.
Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not occur or be achieved, and actual results could differ materially from those projected in the forward-looking statements. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
2
IDEAYA Biosciences, Inc.
Form 10-Q for Quarterly Period Ended June 30, 2024
Table of Contents
3
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements (UNAUDITED).
IDEAYA Biosciences, Inc.
Condensed Balance Sheets
(in thousands, except share and per share amounts)
(Unaudited)
|
|
June 30, |
|
December 31, |
|
||
|
|
2024 |
|
2023 |
|
||
Assets |
|
|
|
|
|
||
Current assets |
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
$ |
|
||
Short-term marketable securities |
|
|
|
|
|
||
Accounts receivable |
|
|
|
|
|
||
Prepaid expenses and other current assets |
|
|
|
|
|
||
Total current assets |
|
|
|
|
|
||
Restricted cash |
|
|
|
|
|
||
Long-term marketable securities |
|
|
|
|
|
||
Property and equipment, net |
|
|
|
|
|
||
Right-of-use assets |
|
|
|
|
|
||
Other non-current assets |
|
|
|
|
|
||
Total assets |
|
$ |
|
$ |
|
||
Liabilities and Stockholders’ Equity |
|
|
|
|
|
||
Current liabilities |
|
|
|
|
|
||
Accounts payable |
|
$ |
|
$ |
|
||
Accrued liabilities |
|
|
|
|
|
||
Operating lease liabilities, current |
|
|
|
|
|
||
Total current liabilities |
|
|
|
|
|
||
Long-term operating lease liabilities |
|
|
|
|
|
||
Total liabilities |
|
|
|
|
|
||
|
|
|
|
|
|||
Stockholders’ equity |
|
|
|
|
|
||
Preferred stock, $ |
|
|
|
|
|
||
Common stock, $ |
|
|
|
|
|
||
Additional paid-in capital |
|
|
|
|
|
||
Accumulated other comprehensive (loss) income |
|
|
( |
) |
|
|
|
Accumulated deficit |
|
|
( |
) |
|
( |
) |
Total stockholders’ equity |
|
|
|
|
|
||
Total liabilities and stockholders’ equity |
|
$ |
|
$ |
|
The accompanying notes are an integral part of these condensed financial statements.
4
IDEAYA Biosciences, Inc.
Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(Unaudited)
|
|
Three Months Ended |
|
Six Months Ended |
|
||||||||
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
||||
Collaboration revenue |
|
$ |
|
$ |
|
$ |
|
$ |
|
||||
Total revenue |
|
|
|
|
|
|
|
|
|
||||
Operating expenses |
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
||||
Total operating expenses |
|
|
|
|
|
|
|
|
|
||||
Loss from operations |
|
|
( |
) |
|
( |
) |
|
( |
) |
|
( |
) |
Other income |
|
|
|
|
|
|
|
|
|
||||
Interest income and other income, net |
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
Unrealized (losses) gains on marketable securities |
|
|
( |
) |
|
|
|
( |
) |
|
|
||
Comprehensive loss |
|
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
Net loss per common share, basic and diluted |
|
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed financial statements.
5
IDEAYA Biosciences, Inc.
Condensed Statements of Stockholders' Equity
(in thousands, except share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
||||||
|
|
|
|
|
|
Additional |
|
Other |
|
|
|
Total |
|
||||||
|
|
Common Stock |
|
Paid-In |
|
Comprehensive |
|
Accumulated |
|
Stockholders' |
|
||||||||
|
|
Shares |
|
Amount |
|
Capital |
|
Income (Loss) |
|
Deficit |
|
Equity |
|
||||||
Balances as of March 31, 2024 |
|
|
|
$ |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
||||
Issuance of common stock related to at-the-market offering program, net of issuance costs |
|
|
|
|
|
|
|
|
— |
|
|
— |
|
|
|
||||
Issuance of common stock upon exercise of stock options |
|
|
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
|||
Employee stock purchase plan (ESPP) purchase |
|
|
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
|||
Stock-based compensation |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
||
Other comprehensive loss |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
— |
|
|
( |
) |
Net loss |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
( |
) |
Balances as of June 30, 2024 |
|
|
|
$ |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Balances as of March 31, 2023 |
|
|
|
$ |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
||||
Issuance of common stock upon follow-on public offering, net of issuance costs |
|
|
|
$ |
|
$ |
|
|
— |
|
|
— |
|
$ |
|
||||
Issuance of common stock related to at-the-market offering program, net of issuance costs |
|
|
|
|
— |
|
|
( |
) |
|
— |
|
|
— |
|
|
( |
) |
|
Issuance of pre-funded warrants to purchase common stock |
|
|
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
|||
Issuance of common stock upon exercise of stock options |
|
|
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
|||
Employee stock purchase plan (ESPP) purchase |
|
|
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
|||
Stock-based compensation |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
||
Other comprehensive income |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
|
||
Net loss |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
( |
) |
Balances as of June 30, 2023 |
|
|
|
$ |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
The accompanying notes are an integral part of these condensed financial statements.
IDEAYA Biosciences, Inc.
6
Condensed Statements of Stockholders' Equity
(in thousands, except share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
||||||
|
|
|
|
|
|
Additional |
|
Other |
|
|
|
Total |
|
||||||
|
|
Common Stock |
|
Paid-In |
|
Comprehensive |
|
Accumulated |
|
Stockholders' |
|
||||||||
|
|
Shares |
|
Amount |
|
Capital |
|
Income (Loss) |
|
Deficit |
|
Equity |
|
||||||
Balances as of December 31, 2023 |
|
|
|
$ |
|
$ |
|
$ |
|
$ |
( |
) |
$ |
|
|||||
Issuance of common stock related to at-the-market offering program, net of issuance costs |
|
|
|
|
|
|
|
|
— |
|
|
— |
|
|
|
||||
Issuance of common stock upon exercise of stock options |
|
|
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
|||
Employee stock purchase plan (ESPP) purchase |
|
|
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
|||
Stock-based compensation |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
||
Other comprehensive loss |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
— |
|
|
( |
) |
Net loss |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
( |
) |
Balances as of June 30, 2024 |
|
|
|
$ |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Balances as of December 31, 2022 |
|
|
|
$ |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
||||
Issuance of common stock upon follow-on public offering, net of issuance costs |
|
|
|
$ |
|
$ |
|
|
— |
|
|
— |
|
$ |
|
||||
Issuance of common stock related to at-the-market offering program, net of issuance costs |
|
|
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
|||
Issuance of pre-funded warrants to purchase common stock |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
||
Issuance of common stock upon exercise of stock options |
|
|
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
|||
Employee stock purchase plan (ESPP) purchase |
|
|
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
|||
Stock-based compensation |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
|
||
Other comprehensive income |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
|
||
Net loss |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
( |
) |
Balances as of June 30, 2023 |
|
|
|
$ |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
The accompanying notes are an integral part of these condensed financial statements.
7
IDEAYA Biosciences, Inc.
Condensed Statements of Cash Flows
(in thousands)
(Unaudited)
|
|
Six Months Ended June 30, |
|
||||
|
|
2024 |
|
2023 |
|
||
Cash flows from operating activities |
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
|
|
||
Depreciation and amortization |
|
|
|
|
|
||
Net amortization (accretion) of premiums (discounts) on marketable securities |
|
|
( |
) |
|
( |
) |
Stock-based compensation |
|
|
|
|
|
||
Amortization of right-of-use assets |
|
|
|
|
|
||
Changes in assets and liabilities |
|
|
|
|
|
||
Accounts receivable |
|
|
|
|
|
||
Prepaid expenses and other assets |
|
|
( |
) |
|
( |
) |
Accounts payable |
|
|
|
|
|
||
Accrued and other liabilities |
|
|
|
|
( |
) |
|
Contract liabilities |
|
|
|
|
( |
) |
|
Lease liabilities |
|
|
( |
) |
|
( |
) |
Net cash used in operating activities |
|
|
( |
) |
|
( |
) |
Cash flows from investing activities |
|
|
|
|
|
||
Purchases of property and equipment, net |
|
|
( |
) |
|
( |
) |
Purchases of marketable securities |
|
|
( |
) |
|
( |
) |
Maturities of marketable securities |
|
|
|
|
|
||
Net cash used in investing activities |
|
|
( |
) |
|
( |
) |
Cash flows from financing activities |
|
|
|
|
|
||
Proceeds from issuance of common stock upon public offering, net of issuance costs |
|
|
|
|
|
||
Proceeds from issuance of common stock related to at-the-market offering program, net of issuance costs |
|
|
|
|
|
||
Proceeds from issuance of pre-funded warrants to purchase common stock, net of issuance costs |
|
|
|
|
|
||
Proceeds from ESPP purchase |
|
|
|
|
|
||
Proceeds from exercise of common stock options |
|
|
|
|
|
||
Net cash provided by financing activities |
|
|
|
|
|
||
Net increase in cash, cash equivalents and restricted cash |
|
|
|
|
|
||
Cash, cash equivalents and restricted cash |
|
|
|
|
|
||
Cash, cash equivalents and restricted cash, at beginning of period |
|
|
|
|
|
||
Cash, cash equivalents and restricted cash, at end of period |
|
$ |
|
$ |
|
||
|
|
|
|
|
|
||
Reconciliation of cash, cash equivalents and restricted cash |
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
$ |
|
||
Restricted cash |
|
|
|
|
|
||
Cash, cash equivalents and restricted cash |
|
$ |
|
$ |
|
||
|
|
|
|
|
|
||
Supplemental disclosure of cash flow information: |
|
|
|
|
|
||
Cash paid for interest |
|
$ |
|
$ |
|
||
Supplemental non-cash investing and financing activities: |
|
|
— |
|
|
— |
|
Purchases of property and equipment in accounts payable and accrued liabilities |
|
$ |
|
$ |
|
||
Unpaid offering costs |
|
|
|
|
|
||
Unpaid at-the-market offering program costs |
|
$ |
|
$ |
|
The accompanying notes are an integral part of these condensed financial statements.
8
IDEAYA Biosciences, Inc.
Notes to Condensed Financial Statements (Unaudited)
1. Organization
Description of the Business
IDEAYA Biosciences, Inc. (the “Company”) is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. The Company is headquartered in South San Francisco, California and was incorporated in the State of Delaware in June 2015. To date, the Company has been primarily engaged in business planning, research, development, recruiting and raising capital.
Follow-On Offering
On April 27, 2023, the Company completed an underwritten public follow-on offering. The offering consisted of
On October 27, 2023, the Company completed an underwritten public follow-on offering. The offering consisted of
At-the-Market Offering
On January 19, 2024, the Company entered into a new Open Market Sales Agreement, or January 2024 Sales Agreement, with Jefferies relating to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of common stock having aggregate gross proceeds of up to $
During the three months ended June 30, 2024, pursuant to the January 2024 Sales Agreement, the Company sold an aggregate of
The Company may cancel its at-the-market program at any time upon written notice, pursuant to its terms.
Liquidity
The Company has incurred significant losses and negative cash flows from operations in all periods since inception and had an accumulated deficit of $
The Company has financed its operations primarily through the sale and issuance of common stock and the upfront payment and certain milestone payments received from GSK.
9
To date, none of the Company’s product candidates have been approved for sale, and the Company has not generated any revenue from commercial products since inception. Management expects operating losses to continue and increase for the foreseeable future, as the Company progresses clinical development activities for its lead product candidates. The Company’s prospects are subject to risks, expenses and uncertainties frequently encountered by companies in the biotechnology industry as discussed under Risks and Uncertainties in Note 2. While the Company has been able to raise multiple rounds of financing, there can be no assurance that in the event the Company requires additional financing, such financing will be available on terms which are favorable or at all. Failure to generate sufficient cash flows from operations, raise additional capital or reduce certain discretionary spending would have a material adverse effect on the Company’s ability to achieve its intended business objectives.
As of June 30, 2024, the Company had cash, cash equivalents and marketable securities of $
2. Summary of Significant Accounting Policies
Basis of Presentation
These condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules and regulations of the United States Securities and Exchange Commission (“SEC”) for interim reporting.
Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted. Accordingly, the unaudited condensed financial statements should be read in conjunction with the audited financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 20, 2024.
Unaudited Condensed Financial Statements
The accompanying financial information for the three and six months ended June 30, 2024 and June 30, 2023 are unaudited. The unaudited condensed financial statements have been prepared on the same basis as the annual audited financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s financial position as of June 30, 2024 and its results of operations for the three and six months ended June 30, 2024 and June 30, 2023 and cash flows for the six months ended June 30, 2024 and June 30, 2023. The results for interim periods are not necessarily indicative of the results expected for the full fiscal year or any other periods.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Such estimates include useful lives of property and equipment, determination of the discount rate for operating leases, accruals for research and development activities, revenue recognition, stock-based compensation, and income taxes. On an ongoing basis, management reviews these estimates and assumptions. Changes in facts and circumstances may alter such estimates and actual results could differ from those estimates.
Risks and Uncertainties
The Company operates in a dynamic and highly competitive industry and is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, contract manufacturers, contract research organizations and collaboration partners, compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical studies and clinical trials and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting. The Company believes that changes in any of the following areas could have a material adverse effect on the Company’s future financial position, results of operations, or cash flows: ability to obtain future financing; advances and trends
10
in new technologies and industry standards; results of clinical trials and collaboration activities; regulatory approval and market acceptance of the Company’s products; development of sales channels; certain strategic relationships; litigation or claims against the Company based on intellectual property, patent, product, regulatory, or other factors; and the Company’s ability to attract and retain employees necessary to support its growth.
Products developed by the Company require approvals from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained or maintained, that the products will receive the necessary approvals, or that any approved products will be commercially viable. If the Company was denied approval, approval was delayed or the Company was unable to maintain approval, it could have a materially adverse impact on the Company. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from other pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees, consultants and other third parties.
The Company has expended and will continue to expend substantial funds to complete the research, development and clinical testing of product candidates. The Company also will be required to expend additional funds to establish commercial-scale manufacturing arrangements and to provide for the marketing and distribution of products that receive regulatory approval. The Company may require additional funds to commercialize its products. The Company is unable to entirely fund these efforts with its current financial resources. If adequate funds are unavailable on a timely basis from operations or additional sources of financing, the Company may have to delay, reduce the scope of or eliminate one or more of its research or development programs which would materially and adversely affect its business, financial condition and operations.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents and marketable securities. Substantially all the Company’s cash, cash equivalents and marketable securities are held by three financial institutions that management believes are of high credit quality. Such deposits may, at times, exceed federally insured limits.
The Company’s investment policy addresses credit ratings, diversification, and maturity dates.
The Company invests its cash equivalents and marketable securities in money market funds, U.S. government securities, commercial paper, and corporate bonds. The Company limits its credit risk associated with cash equivalents and marketable securities by placing them with banks and institutions it believes are creditworthy and in highly rated investments and, by policy, limits the amount of credit exposure with any one commercial issuer. The Company has not experienced any credit losses on its deposits of cash, cash equivalents or marketable securities.
Summary of Significant Accounting Policies
There have been no material changes in the accounting policies from those disclosed in the financial statements and the related notes included in the Company's Annual Report on Form 10-K, filed with the SEC on February 20, 2024.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) under its accounting standard codifications (“ASC”) or other standard setting bodies and adopted by the Company as of the specified effective date, unless otherwise discussed below.
New Accounting Pronouncements, Not yet Adopted
On October 2023, the FASB issued ASU 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC's Disclosure Update and Simplification Initiative, which modifies the disclosure or presentation requirements related to variety of FASB Accounting Standard Codification topics. The effective date for each amendment will be the date on which the SEC's removal of that related disclosure from Regulation S-X or Regulation S-K is effective. If by June 30, 2027, the SEC has not removed the applicable requirement from Regulation S-X or Regulation S-K, the pending content of the associated amendment will be removed from the
11
Codification and will not become effective for any entities. The Company is currently evaluating the effect of adopting this ASU.
On December 14, 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which amends the guidance in ASC 740, Income Taxes. The ASU is intended to improve the transparency of income tax disclosures by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. The ASU’s amendments are effective for public business entities for annual periods beginning after December 15, 2024. Entities are permitted to early adopt the standard “for annual financial statements that have not yet been issued or made available for issuance.” Adoption is either prospectively or retrospectively; the Company will adopt this ASU on a prospective basis. The Company is currently evaluating the impact of the ASU but does not expect any material impacts upon adoption.
3. Fair Value Measurement and Marketable Securities
The Company applies fair value accounting for all financial assets and liabilities and non-financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:
Level 1—Observable inputs, such as quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2—Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3—Unobservable inputs which reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.
As of June 30, 2024, financial assets measured and recognized at fair value are as follows (in thousands):
|
|
|
|
June 30, 2024 |
|
||||||||||
|
|
|
|
Amortized |
|
Gross |
|
Gross |
|
Estimated |
|
||||
Assets |
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. government securities |
|
Level 2 |
|
$ |
|
$ |
|
$ |
( |
) |
$ |
|
|||
Corporate bonds |
|
Level 2 |
|
|
|
|
|
|
( |
) |
|
|
|||
Commercial paper(1) |
|
Level 2 |
|
|
|
|
|
|
( |
) |
|
|
|||
Marketable securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|||
Money market funds(2) |
|
Level 1 |
|
|
|
|
— |
|
|
— |
|
|
|
||
Total fair value of assets |
|
|
|
$ |
|
$ |
|
$ |
( |
) |
$ |
|
12
As of December 31, 2023, financial assets measured and recognized at fair value are as follows (in thousands):
|
|
|
|
December 31, 2023 |
|
||||||||||
|
|
|
|
Amortized |
|
Gross |
|
Gross |
|
Estimated |
|
||||
Assets |
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. government securities(1) |
|
Level 2 |
|
$ |
|
$ |
|
$ |
( |
) |
$ |
|
|||
Corporate bonds |
|
Level 2 |
|
|
|
|
|
|
( |
) |
|
|
|||
Commercial paper(2) |
|
Level 2 |
|
|
|
|
|
( |
) |
|
|
||||
Marketable securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|||
Money market funds(3) |
|
Level 1 |
|
|
|
|
— |
|
|
— |
|
|
|
||
Total fair value of assets |
|
|
|
$ |
|
$ |
|
$ |
( |
) |
$ |
|
As of June 30, 2024 and December 31, 2023, all marketable securities had a remaining maturity of less than
The Company considers available evidence in evaluating potential other-than-temporary impairments of its marketable securities, including the duration and extent to which fair value is less than cost, and the Company’s ability and intent to hold the investment. As of June 30, 2024 and December 31, 2023, the Company held certain securities in an unrealized loss position. These unrealized losses were considered to be temporary as the Company expects to recover the entire amortized cost basis on the securities in unrealized loss positions based on the creditworthiness of the underlying issuer, and the Company neither intends to sell these securities nor considers it more likely than not that the Company would be required to sell any such security before its anticipated recovery. As a result, the Company did not consider any of these investments to be other-than-temporarily impaired at June 30, 2024 and December 31, 2023.
4. Balance Sheet Components
Property and Equipment, Net
Property and equipment, net consisted of the following (in thousands):
|
Useful Life |
|
June 30, |
|
December 31, |
|
||
|
(In Years) |
|
2024 |
|
2023 |
|
||
Laboratory equipment |
|
$ |
|
$ |
|
|||
Computer equipment |
|
|
|
|
|
|||
Software |
|
|
|
|
|
|||
Leasehold improvements |
|
|
|
|
|
|||
Furniture and fixtures |
|
|
|
|
|
|||
Total property and equipment |
|
|
|
|
|
|
||
Less: Accumulated depreciation and amortization |
|
|
|
( |
) |
|
( |
) |
Property and equipment, net |
|
|
$ |
|
$ |
|
13
Depreciation and amortization expense was $
Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
|
|
June 30, |
|
December 31, |
|
||
|
|
2024 |
|
2023 |
|
||
Accrued research and development expenses |
|
$ |
|
$ |
|
||
Accrued salaries and benefits |
|
|
|
|
|
||
Legal and professional fees |
|
|
|
|
|
||
Other |
|
|
|
|
|
||
Accrued liabilities |
|
$ |
|
$ |
|
5. Operating Leases
The Company leases its laboratory and office facilities at 7000 Shoreline Court, South San Francisco for approximately
In November 2023, the Company entered into a lease agreement for approximately
In June 2023, the Company entered into a lease agreement for approximately
Future minimum lease payments under operating leases included on the Company's condensed balance sheet are as follows:
As of June 30, 2024 |
|
Operating Leases |
|
|
2024 |
|
$ |
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
Total future minimum lease payments |
|
|
|
|
Less: imputed interest |
|
|
( |
) |
Total operating lease liabilities |
|
$ |
|
The following table summarizes other information about the Company's operating leases:
|
|
As of |
|
|||||
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
||
Remaining Lease Term |
|
|
|
|
|
|
||
Discount Rate |
|
|
% |
|
|
% |
14
Operating lease costs were $
Variable lease costs were $
During the six months ended June 30, 2024 and June 30, 2023, cash paid for amounts included in the measurement of lease liabilities was $
6. Commitments and Contingencies
Contingencies
From time to time, the Company may be involved in litigation related to claims that arise in the ordinary course of its business activities. The Company accrues for these matters when it is probable that future expenditures will be made and these expenditures can be reasonably estimated. As of June 30, 2024, the Company does not believe that any such matters, individually or in the aggregate, will have a material adverse effect on the Company’s financial position, results of operations or cash flows.
Indemnification
The Company enters into standard indemnification arrangements in the ordinary course of business with vendors, clinical trial sites and other parties. Pursuant to these arrangements, the Company indemnifies, holds harmless and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party. The term of these indemnification agreements is generally perpetual any time after the execution of the agreement. The maximum potential amount of future payments the Company could be required to make under these arrangements is not determinable. The Company has never incurred costs to defend lawsuits or settle claims related to these indemnification agreements. Accordingly, the Company has not recorded a liability related to such indemnification agreements as of June 30, 2024.
7. Income Taxes
For the three and six months ended June 30, 2024 and June 30, 2023, the Company did
The Company is under audit in California for tax years 2020-2021.
8. Common Stock
As of June 30, 2024 and December 31, 2023, the Company’s certificate of incorporation authorized the Company to issue
On April 27, 2023, the Company completed an underwritten public follow-on offering. The offering consisted of
15
On October 27, 2023, the Company completed an underwritten public follow-on offering. The offering consisted of
As of June 30, 2024, the following aggregate warrants to purchase shares of the Company’s common stock were issued and outstanding:
Issue Date |
|
Expiration Date |
|
Exercise Price per Share |
|
Number of Shares subject to Outstanding Warrants |
|
None |
|
$ |
|
||
|
None |
|
$ |
|
The warrants are classified as a component of Stockholders’ Equity within Additional Paid-in-Capital. The warrants are classified as equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, are indexed to the Company’s common stock and meet the equity classification criteria. The warrants will not expire until they are fully exercised. As of June 30, 2024, no shares underlying the warrants had been exercised.
The Company had reserved common stock for future issuance as follows:
|
|
June 30, |
|
December 31, |
|
|
2024 |
|
2023 |
Outstanding options under the 2015, 2019 and 2023 Plans |
|
|
||
Shares available for grant under the 2019 Plan |
|
|
||
Shares available for grant under the 2023 Inducement Plan |
|
|
||
Shares available under the Employee Stock Purchase Plan |
|
|
||
Pre-funded warrants issued and outstanding |
|
|
||
Total |
|
|
9. Stock-Based Compensation
2023 Inducement Plan
On February 24, 2023, the Company adopted the IDEAYA Biosciences, Inc. 2023 Employment Inducement Award Plan (the “2023 Inducement Plan”), pursuant to which the Company reserved
On June 25, 2024, the Company amended the 2023 Employment Inducement Award Plan, increasing the number of shares available for issuance by
As of June 30, 2024, the number of shares available for issuance under the 2023 Inducement Plan was
2019 Incentive Award Plan
In May 2019, the Company’s board of directors adopted and the Company’s stockholders approved the 2019 Incentive Award Plan (the “2019 Plan”), under which the Company may grant cash and equity-based incentive awards to the Company’s employees, consultants and directors. Following the effectiveness of the 2019 Plan, the Company will not make any further grants under the 2015 Equity Incentive Plan (the “2015 Plan”). However, the
16
2015 Plan continues to govern the terms and conditions of the outstanding awards granted under it. Shares of common stock subject to awards granted under the 2015 Plan that are forfeited or lapse unexercised and which following the effective date of the 2019 Plan are not issued under the 2015 Plan will be available for issuance under the 2019 Plan.
Options granted under the 2019 Plan may be either incentive stock options (“ISOs”) or nonqualified stock options (“NSOs”). ISOs may be granted only to Company employees (including officers and directors who are also employees). NSOs may be granted to Company employees, directors and consultants.
The 2019 Plan is subject to an annual increase on the first day of each year beginning in 2020 and ending in 2029, equal to the lesser of
As of June 30, 2024, the number of shares available for issuance under the 2019 Plan was
2015 Equity Incentive Plan
In 2015, the Company established its 2015 Plan which provides for the granting of stock options to employees, directors and consultants of the Company. Options granted under the 2015 Plan may be either ISOs or NSOs.
2019 Employee Stock Purchase Plan
In May 2019, the Company’s board of directors adopted and the Company’s stockholders approved the 2019 Employee Stock Purchase Plan (the “ESPP”). The ESPP provides eligible employees with the opportunity to acquire an ownership interest in the Company through periodic payroll deductions up to
The ESPP is intended to constitute an “employee stock purchase plan” under Section 423(b) of the Internal Revenue Code of 1986, as amended. A total of
As of June 30, 2024, the number of shares available for issuance under the ESPP was
Stock-Based Compensation Expense
Total stock-based compensation expense recorded related to awards granted to employees and non-employees was as follows (in thousands):
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
||||||||
|
|
2024 |
|
2023 |