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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934
For the quarterly period ended
September 30,
2025
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:
001-38915
IDEAYA Biosciences, Inc.
(Exact name of registrant as specified in its charter)
Delaware
47-4268251
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
5000 Shoreline Court
,
Suite 300
South San Francisco
,
California
94080
(Address of principal executive offices)
(Zip Code)
(
650
)
443-6209
(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
Common Stock, $0.0001 par value per share
IDYA
Nasdaq Global Select Market
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.
Yes
☒ No ☐
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).
Yes
☒ No ☐
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.
Large accelerated filer
☒
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 October 31, 2025, the registrant had
87,666,408
shares of common stock, $0.0001 par value per share, outstanding.
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:
•
the scope, progress, results and costs of developing our product candidates or any other future product candidates, and conducting preclinical studies and clinical trials, including our darovasertib (PKC) Phase 2/3 clinical trials, IDE397 (MAT2A) Phase 1/2 clinical trials, IDE849 (DLL3) Phase 1 clinical trial, IDE161 (PARG) Phase 1/2 clinical trial, IDE275 / GSK959 (Werner Helicase) Phase 1 clinical trial, IDE705 / GSK101 (Pol Theta Helicase) Phase 1 clinical trial, IDE892 Phase 1 clinical trial, as well as the potential clinical utility and tolerability of our product candidates;
•
our clinical and regulatory development plans;
•
the scope, progress, results and costs related to the research and development of our precision medicine target and biomarker discovery platform, including costs related to the development of our proprietary libraries and database of tumor genetic information and specific cancer-target dependency networks;
•
our expectations about the impact of macroeconomic developments, such as health epidemics or pandemics, macro-economic uncertainties, social unrest, geopolitical hostilities, natural disasters or other catastrophic events, on our business, and operations, including clinical trials, manufacturing suppliers and collaborators, and on our results of operations and financial condition;
•
the availability of companion diagnostics for biomarkers associated with our product candidates and any future product candidates, or the cost of coordinating and/or collaborating with certain diagnostic companies for the manufacture and supply of companion diagnostics;
•
the timing of and costs involved in obtaining and maintaining regulatory approval (or certification in certain foreign jurisdictions) for any current or future product candidates and companion diagnostics, and any related restrictions, limitations, and/or warnings in the label of an approved product candidate;
•
our expectations regarding the potential market size and size of the potential patient populations for darovasertib, IDE397, IDE849, IDE161, IDE275 / GSK959, IDE705 / GSK101, IDE892, our other product candidates and any future product candidates, if approved for commercial use;
•
the timing and amount of any option exercised, milestone, royalty or other payments we may or may not receive pursuant to any current or future collaboration or license agreement, including under the Collaboration, Option and License Agreement with an affiliate of GSK plc, GLAXOSMITHKLINE INTELLECTUAL PROPERTY (NO. 4) LIMITED, or GSK and the License Agreement with Les Laboratoires Servier, or Servier;
1
•
our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including our Collaboration, Option and License Agreement with GSK, our Clinical Study Collaboration and Supply Agreement with Gilead Sciences, Inc., our Clinical Trial Collaboration and Supply Agreement with MSD International Business GmbH, our Clinical Trial Collaboration and Supply Agreements with Pfizer Inc., our Clinical Trial Collaboration and Supply Agreement with Amgen Inc., our License Agreement with Novartis, our Option and License Agreement with Cancer Research Technologies Ltd. and the University of Manchester, our Option and License Agreement with Biocytogen Pharmaceuticals (Beijing) Co., Ltd., our License Agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd., and our License Agreement with Servier;
•
the timing of commencement of future nonclinical studies and clinical trials and research and development programs;
•
our ability to acquire, discover, develop and advance product candidates into, and successfully complete, clinical trials;
•
our intentions and our ability to establish collaborations and/or partnerships;
•
the timing or likelihood of regulatory filings and approvals for our product candidates;
•
our commercialization, marketing and manufacturing capabilities and expectations;
•
our intentions with respect to the commercialization of our product candidates;
•
the pricing and reimbursement of our product candidates, if approved;
•
the implementation of our business model and strategic plans for our business, product candidates and technology platforms, including additional indications for which we may pursue;
•
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates, including the projected terms of patent protection;
•
our potential involvement in lawsuits in connection with enforcing our intellectual property rights;
•
our potential involvement in third party interference, opposition, derivation or similar proceedings with respect to our patent rights and other challenges to our patent rights and patent infringement claims;
•
estimates of our expenses, future revenue, capital requirements, our needs for additional financing and our ability to obtain additional capital;
•
our future financial performance; and
•
developments and projections relating to our competitors and our industry, including competing therapies and procedures, as well as the competitive position of our product candidates.
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 September 30, 2025
(
in thousands, except share and per share amounts
)
(
Unaudited
)
September 30,
December 31,
2025
2024
Assets
Current assets
Cash and cash equivalents
$
298,927
$
84,378
Short-term marketable securities
487,967
591,941
Prepaid expenses and other current assets
15,761
13,394
Total current assets
802,655
689,713
Restricted cash
805
805
Long-term marketable securities
349,960
405,832
Property and equipment, net
8,172
8,966
Right-of-use assets
23,544
18,775
Total assets
$
1,185,136
$
1,124,091
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable
$
18,433
$
15,421
Accrued liabilities
45,258
30,352
Contract liabilities, current
490
Operating lease liabilities, current
328
298
Total current liabilities
64,509
46,071
Long-term contract liabilities
1,676
—
Long-term operating lease liabilities
26,917
18,873
Total liabilities
93,102
64,944
Commitments and contingencies (Note 6)
Stockholders’ equity
Preferred stock, $
0.0001
par value,
10,000,000
shares authorized as of September 30, 2025 and December 31, 2024;
no
shares issued and outstanding as of September 30, 2025 and December 31, 2024
—
—
Common stock, $
0.0001
par value,
300,000,000
shares authorized as of September 30, 2025 and December 31, 2024;
87,666,408
and
86,503,509
shares issued and outstanding as of September 30, 2025 and December 31, 2024
9
9
Additional paid-in capital
1,743,239
1,681,167
Accumulated other comprehensive income
2,052
812
Accumulated deficit
(
653,266
)
(
622,841
)
Total stockholders’ equity
1,092,034
1,059,147
Total liabilities and stockholders’ equity
$
1,185,136
$
1,124,091
The accompanying notes are an integral part of these condensed financial statements.
4
IDEAYA Biosciences, Inc.
Condensed Statements of Operations and Comprehensive Income (Loss
)
(
in thousands, except share and per share amounts
)
(
Unaudited
)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
Collaboration revenue
$
207,834
$
—
$
207,834
$
—
Total revenue
207,834
—
207,834
—
Operating expenses
Research and development
82,993
57,152
228,105
154,490
General and administrative
16,389
9,741
44,472
28,347
Total operating expenses
99,382
66,893
272,577
182,837
Income (loss) from operations
108,452
(
66,893
)
(
64,743
)
(
182,837
)
Other income
Interest income and other income, net
10,792
15,072
34,318
38,672
Net income (loss)
$
119,244
$
(
51,821
)
$
(
30,425
)
$
(
144,165
)
Unrealized gains on marketable securities
531
5,252
1,240
3,274
Comprehensive income (loss)
$
119,775
$
(
46,569
)
$
(
29,185
)
$
(
140,891
)
Net income (loss) per common share, basic
$
1.35
$
(
0.60
)
$
(
0.34
)
$
(
1.81
)
Weighted-average common shares outstanding, basic
88,526,781
86,188,510
88,452,395
79,776,728
Net income (loss) per common share, diluted
$
1.33
$
(
0.60
)
$
(
0.34
)
$
(
1.81
)
Weighted-average common shares outstanding, diluted
89,690,878
86,188,510
88,452,395
79,776,728
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 June 30, 2025
87,641,776
$
9
$
1,730,633
$
1,521
$
(
772,510
)
$
959,653
Issuance of common stock upon exercise of stock options
24,632
—
473
—
—
473
Issuance of common stock related to at-the-market offering program, net of issuance costs
—
(
84
)
—
—
(
84
)
Stock-based compensation
—
—
12,217
—
—
12,217
Other comprehensive income
—
—
—
531
—
531
Net income
—
—
—
—
119,244
119,244
Balances as of September 30, 2025
87,666,408
$
9
$
1,743,239
$
2,052
$
(
653,266
)
$
1,092,034
Balances as of June 30, 2024
76,090,834
$
8
$
1,373,774
$
(
1,416
)
$
(
440,708
)
$
931,658
Issuance of common stock upon follow-on public offering, net of issuance costs
8,355,714
1
274,355
—
—
274,356
Issuance of pre-funded warrants to purchase common stock
—
—
9,400
—
—
9,400
Exercise of pre-funded warrants
1,749,993
—
—
—
—
-
Issuance of common stock related to at-the-market offering program, net of issuance costs
—
—
(
27
)
—
—
(
27
)
Issuance of common stock upon exercise of stock options
161,315
—
2,385
—
—
2,385
Stock-based compensation
—
—
9,215
—
—
9,215
Other comprehensive income
—
—
—
5,252
—
5,252
Net loss
—
—
—
—
(
51,821
)
(
51,821
)
Balances as of September 30, 2024
86,357,856
$
9
$
1,669,102
$
3,836
$
(
492,529
)
$
1,180,418
The accompanying notes are an integral part of these condensed financial statements.
6
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 December 31, 2024
86,503,509
$
9
$
1,681,167
$
812
$
(
622,841
)
$
1,059,147
Issuance of common stock related to at-the-market offering program, net of issuance costs
984,000
—
24,914
—
—
24,914
Issuance of common stock upon exercise of stock options
130,409
—
2,016
—
—
2,016
Employee stock purchase plan (ESPP) purchase
48,490
—
820
—
—
820
Stock-based compensation
—
—
34,322
—
—
34,322
Other comprehensive income
—
—
—
1,240
—
1,240
Net loss
—
—
—
—
(
30,425
)
(
30,425
)
Balances as of September 30, 2025
87,666,408
$
9
$
1,743,239
$
2,052
$
(
653,266
)
$
1,092,034
Balances as of December 31, 2023
65,039,369
$
7
$
968,885
$
562
$
(
348,364
)
$
621,090
Issuance of common stock upon follow-on public offering, net of issuance costs
8,355,714
1
274,355
—
—
274,356
Issuance of pre-funded warrants to purchase common stock
-
—
9,400
—
—
9,400
Exercise of pre-funded warrants
1,749,993
—
—
—
—
—
Issuance of common stock related to at-the-market offering program, net of issuance costs
10,182,382
1
379,927
—
—
379,928
Issuance of common stock upon exercise of stock options
1,001,355
—
10,493
—
—
10,493
Employee stock purchase plan (ESPP) purchase
29,043
—
781
—
—
781
Stock-based compensation
—
—
25,261
—
—
25,261
Other comprehensive income
—
—
-
3,274
—
3,274
Net loss
—
—
-
—
(
144,165
)
(
144,165
)
Balances as of September 30, 2024
86,357,856
$
9
$
1,669,102
$
3,836
$
(
492,529
)
$
1,180,418
The accompanying notes are an integral part of these condensed financial statements.
7
IDEAYA Biosciences, Inc.
Condensed S
tatements of Cash Flows
(
in thousands
)
(
Unaudited
)
Nine Months Ended September 30,
2025
2024
Cash flows from operating activities
Net loss
$
(
30,425
)
$
(
144,165
)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities
Depreciation and amortization
1,979
1,815
Net accretion of discounts on marketable securities
(
8,452
)
(
18,317
)
Stock-based compensation
34,322
25,261
Amortization of right-of-use assets
1,417
1,376
Changes in assets and liabilities
Prepaid expenses and other assets
(
2,278
)
(
4,440
)
Accounts payable
3,555
5,304
Accrued and other liabilities
15,226
8,520
Contract liabilities
2,166
—
Lease liabilities
1,888
(
1,283
)
Net cash provided by (used in) operating activities
19,398
(
125,929
)
Cash flows from investing activities
Purchases of property and equipment, net
(
2,035
)
(
2,755
)
Purchases of marketable securities
(
371,751
)
(
854,268
)
Maturities of marketable securities
541,288
551,573
Net cash provided by (used in) investing activities
167,502
(
305,450
)
Cash flows from financing activities
Proceeds from issuance of common stock upon public offering, net of issuance costs
—
274,690
Proceeds from issuance of pre-funded warrants to purchase common stock, net of issuance costs
—
9,400
Proceeds from issuance of common stock related to at-the-market offering program, net of issuance costs
24,901
379,944
Proceeds from ESPP purchase
820
781
Proceeds from exercise of common stock options
1,928
9,983
Net cash provided by financing activities
27,649
674,798
Net increase in cash, cash equivalents and restricted cash
214,549
243,419
Cash, cash equivalents and restricted cash
Cash, cash equivalents and restricted cash, at beginning of period
85,183
157,775
Cash, cash equivalents and restricted cash, at end of period
$
299,732
$
401,194
Reconciliation of cash, cash equivalents and restricted cash
Cash and cash equivalents
$
298,927
$
400,283
Restricted cash
805
911
Cash, cash equivalents and restricted cash
$
299,732
$
401,194
Supplemental disclosure of cash flow information:
Cash paid for interest
$
—
$
25
Supplemental non-cash investing and financing activities:
Right-of-use asset obtained in exchange for a new operating lease liability
$
6,186
$
17,515
Purchases of property and equipment in accounts payable and accrued liabilities
629
1,278
Unpaid offering costs
—
334
Unpaid at-the-market offering program costs
$
—
$
16
The accompanying notes are an integral part of these condensed financial statements.
8
IDEAYA Biosciences, Inc.
Notes to Condensed Financi
al Statements (Unaudited)
1. Organization
Description of the Business
IDEAYA Biosciences, Inc. (the “Company”) is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies to address unmet medical needs in cancer. The Company is headquartered in South San Francisco, California and was incorporated in the State of Delaware in June 2015.
Follow-On Offering
On July 11, 2024, the Company completed an underwritten public follow-on offering. The offering consisted of
8,355,714
shares of the Company's common stock, par value $
0.0001
per share (“common stock”), at an offering price to the public of $
35.00
per share, including
1,127,142
shares of common stock upon the exercise in full of the overallotment option by the underwriters, as well as pre-funded warrants to purchase
285,715
shares of common stock at a public offering price of $
34.9999
per underlying share, in each case before underwriting discounts and commissions. Pursuant to the offering, the Company received aggregate gross proceeds of approximately $
302.4
million, before deducting underwriting discounts and commissions and other offering expenses, resulting in net proceeds of approximately $
283.8
million, after deducting underwriting discounts and commissions and other offering expenses.
At-the-Market Offering
On January 19, 2024, the Company entered into an Open Market Sales Agreement (the “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 $
350.0
million through Jefferies as sales agent.
During the nine months ended September 30, 2025, the Company
sold an aggregate of
984,000
shares of its common stock for aggregate net proceeds of $
25.0
million at a weighted average sales price of approximately $
26.00
per share under the at-the-market offering program pursuant to the January 2024 Sales Agreement with Jefferies as sales agent.
As of September 30, 2025
, approximately $
156.6
million of common stock remained available to be sold pursuant to the January 2024 Sales Agreement.
The Company may cancel its at-the-market offering program at any time upon written notice, pursuant to its terms.
Liquidity
The Company has primarily incurred significant losses and negative cash flows from operations in all periods since inception and had an accumulated deficit of $
653.3
million as of
September 30, 2025.
The Company has financed its operations primarily through the sale and issuance of common stock, the upfront payment and certain milestone payments received from GSK and the upfront payment received from Les Laboratoires Servier.
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.
9
As of September 30, 2025, the Company had cash, cash equivalents and marketable securities of approximately $
1.14
billion. Management believes that the Company’s current cash, cash equivalents and marketable securities will be sufficient to fund its planned operations for at least 12 months from the date of the issuance of these financial statements.
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, 2024 filed with the SEC on February 18, 2025
.
Unaudited Condensed Financial Statements
The accompanying financial information for the three and nine months ended September 30, 2025 and September 30, 2024 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 September 30, 2025 and December 31, 2024, its results of operations for the three and nine months ended September 30, 2025 and September 30, 2024 and cash flows for the nine months ended September 30, 2025 and September 30, 2024
. 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 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
10
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 18, 2025.
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 Adopted
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which improves reportable segment disclosure requirements through enhanced disclosures about significant segment expenses. These amendments enhance interim disclosure requirements, require disclosure of the title and position of the chief operating decision maker (“CODM”), require disclosure of significant segment expenses that are regularly provided to the CODM, clarify circumstances for disclosure of more than one segment profit or loss measure and require that a public entity that has a single reportable segment provide all disclosures required by ASC 280 and amendments. This ASU update is effective for fiscal years beginning after December 15, 2023 for the Company’s annual report, and interim periods within fiscal years beginning after December 15, 2024. The Company
adopted
this ASU for the annual report for the fiscal year beginning
January 1, 2024
and for the quarterly report for the period beginning January 1, 2025. The adoption of this ASU resulted in additional disclosures in Note 13. Segment Information.
11
New Accounting Pronouncements, Not yet Adopted
In 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 Codification and will not become effective for any entities. The Company is currently evaluating the effect of adopting this ASU.
In December 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. This ASU will likely result in additional disclosures.
In November 2024, the FASB issued ASU 2024-03 - Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. The ASU requires more detailed disclosures about the types of expenses in commonly presented expense captions such as cost of sales, selling, general and administrative expenses and research and development expenses. This includes separate footnote disclosure for expenses such as purchases of inventory, employee compensation, depreciation and intangible asset amortization. Public business entities are required to apply the guidance prospectively and may apply it retrospectively. The ASU's amendments are effective for public business entities for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Public business entities are required to apply the guidance prospectively and may apply it retrospectively. This ASU will likely result in additional disclosures.
In January 2025, the FASB issued ASU 2025-01 - Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date. The amendments in this ASU clarify that ASU 2024-03 is effective for public business entities for annual reporting periods beginning after December 15, 2026 and interim reporting periods within annual reporting periods beginning after December 15, 2027. This ASU will likely result in additional disclosures.
In July 2025, the FASB issued ASU 2025-05 - Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets. The amendments in this ASU simplify the estimation of credit losses on current accounts receivable and current contract assets arising from transactions accounted for under ASC 606. The ASU's amendments are effective for all entities for annual reporting periods beginning after 15 December 2025, and interim reporting periods within those annual reporting periods. The Company is currently evaluating the effect of adopting this ASU.
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.
12
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 consider counterparty credit risk in its assessment of fair value.
As of
September 30, 2025, financial assets measured and recognized at fair value are as follows (in thousands):
September 30, 2025
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Estimated
Fair Value
Assets
U.S. government securities
Level 2
$
487,555
$
1,146
$
(
52
)
$
488,649
Corporate bonds
Level 2
332,865
974
(
12
)
333,827
Commercial paper
Level 2
24,817
—
(
4
)
24,813
Subtotal
845,237
2,120
(
68
)
847,289
Money market funds
Level 1
276,957
—
—
276,957
Cash
12,608
—
—
12,608
Total fair value of assets
$
1,134,802
$
2,120
$
(
68
)
$
1,136,854
Included in cash and cash equivalents
(1)
298,928
—
(
1
)
298,927
Included in marketable securities, current
(2)
487,059
930
(
22
)
487,967
Included in marketable securities, non-current
(3)
348,815
1,190
(
45
)
349,960
Total fair value of assets
$
1,134,802
$
2,120
$
(
68
)
$
1,136,854
(1) $
9.4
million of commercial paper was included in cash and cash equivalents on the condensed balance sheet due to securities with
purchase dates within 90 days of maturity dates.
(2) The Company’s short-term marketable securities mature in one year or less.
(3) The Company’s long-term marketable securities mature between one and three years.
13
As of December 31, 2024, financial assets measured and recognized at fair value are as follows (in thousands):
December 31, 2024
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Estimated
Fair Value
Assets
U.S. government securities
Level 2
$
552,008
$
1,214
$
(
353
)
$
552,869
Corporate bonds
Level 2
363,197
357
(
419
)
363,135
Commercial paper
Level 2
89,109
21
(
8
)
89,122
Subtotal
1,004,314
1,592
(
780
)
1,005,126
Money market funds
Level 1
57,626
—
—
57,626
Cash
19,399
—
—
19,399
Total fair value of assets
$
1,081,339
$
1,592
$
(
780
)
$
1,082,151
Included in cash and cash equivalents
(1)
84,379
—
(
1
)
84,378
Included in marketable securities, current
(2)
591,089
928
(
76
)
591,941
Included in marketable securities, non-current
(3)
405,871
664
(
703
)
405,832
Total fair value of assets
$
1,081,339
$
1,592
$
(
780
)
$
1,082,151
(1) $
7.4
million of commercial paper was included in cash and cash equivalents on the condensed balance sheet due to securities with
purchase dates within 90 days of maturity dates.
(2) The Company’s short-term marketable securities mature in one year or less.
(3) The Company’s long-term marketable securities mature between one and three years.
14
As of September 30, 2025 and December 31, 2024, all marketable securities had a remaining maturity of less than
three
years
. There were
no
financial liabilities measured and recognized at fair value as of
September 30, 2025 and December 31, 2024.
As of September 30, 2025 and December 31, 2024, certain securities were held in an unrealized loss position. Based on review of the portfolio of marketable securities and the creditworthiness of the underlying issuer, the Company determined that the decline in fair value below cost did not result from credit-related factors. Additionally, the Company does not intend to sell these securities, nor will it be required to sell before recovery of the amortized cost basis at maturity.
As a result,
no
credit-related losses have been recognized for any of the periods presented.
4. Balance Sheet Components
Property and Equipment, Net
Property and equipment, net consisted of the following (in thousands):
Useful Life
September 30,
December 31,
(In Years)
2025
2024
Laboratory equipment
5
$
14,637
$
13,513
Computer equipment
3
503
503
Software
3
267
231
Leasehold improvements
Shorter of useful life or lease term
4,938
4,913
Furniture and fixtures
5
1,517
1,517
Total property and equipment
21,862
20,677
Less: Accumulated depreciation and amortization
(
13,690
)
(
11,711
)
Property and equipment, net
$
8,172
$
8,966
Depreciation and amortization expense was $
0.7
million and $
0.6
million for the
three months ended September 30, 2025 and September 30, 2024, respectively. Depreciation and amortization expense was $
2.0
million and $
1.8
million for the nine months ended September 30, 2025 and September 30, 2024, respectively.
Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
September 30,
December 31,
2025
2024
Accrued research and development expenses
$
32,878
$
19,956
Accrued salaries and benefits
9,382
8,233
Legal and professional fees
2,370
1,213
Other
628
950
Accrued liabilities
$
45,258
$
30,352
15
5. Operating Leases
In June 2023, the Company entered into a lease agreement for approximately
44,000
square feet of laboratory and office facilities at 5000 Shoreline Court, South San Francisco, California.
The lease term is
120 months
, and
the Company has an option to
extend the lease term
for a total of two consecutive five-year periods.
This lease agreement commenced in August 2024.
In May 2024, the Company amended its 5000 Shoreline Court facility lease agreement to expand the size of the original premises by adding approximately
11,321
rentable square feet of additional space. The amendment to the lease term commenced in January 2025.
The Company's lease at 7000 Shoreline Court, South San Francisco, California, expired in September 2024.
In November 2023, the Company entered into a lease agreement for approximately
5,700
square feet of space at 11710 El Camino Real, San Diego, California for corporate office space.
The lease commenced in
December 2023
and expires in
March 2028
.
The Company has an option to
renew the lease
for
three years
.
Future minimum lease payments under operating leases included on the Company's condensed balance sheet are as follows:
As of September 30, 2025
Operating Leases
2025
$
97
2026
1,944
2027
5,379
2028
5,248
2029
5,323
Thereafter
28,464
Total future minimum lease payments
46,455
Less: imputed interest
(
19,210
)
Total operating lease liabilities
$
27,245
The following table summarizes other information about the Company’s operating leases:
As of
September 30, 2025
December 31, 2024
Remaining Lease Term
8.9
9.4
Discount Rate
11.5
%
12.6
%
16
Operating lease costs were $
1.2
million and $
0.7
million for the three months ended September 30, 2025 and September 30, 2024, respectively. Operating lease costs were $
3.7
million and $
1.7
million for the nine months ended September 30, 2025 and September 30, 2024, respectively.
Variable lease costs were $
0.5
million and $
0.4
million for the three months ended September 30, 2025 and September 30, 2024, respectively. Variable lease costs were $
1.8
million and $
1.1
million for the nine months ended September 30, 2025 and September 30, 2024, respectively. Variable lease costs represent additional costs incurred, related to administration, maintenance and property tax costs incurred, which are billed based on both usage and as a percentage of the Company’s share of total square footage.
During the nine months ended September 30, 2025 and September 30, 2024, cash paid for amounts included in the measurement of lease liabilities were $
0.3
million and $
1.6
million, respectively.
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 September 30, 2025, 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 September 30, 2025.
7. Inc
ome Taxes
The Company did
no
t record a federal or state income tax provision due to its net losses for the
nine months ended September 30, 2025 and September 30, 2024. In addition, the Company continues to maintain a full valuation allowance against its net deferred tax assets as the Company believes it is not more likely than not that the benefit will be realized.
In July 2025, Congress passed and the President signed into law H.R. 1, the One Big Beautiful Bill Act (“Tax Act”
) which addresses certain business tax provisions enacted as a part of the 2017 Tax Cuts and Jobs Act including restoration of
100
% bonus depreciation under Section 168(k) and Section 174 expensing for US-based research. The Tax Act did not result in a material impact to the Company’s income tax provision or effective tax rate.
8. Common Stock
As of September 30, 2025 and December 31, 2024
, the Company’s certificate of incorporation authorized the Company to issue
300,000,000
shares of common stock at a par value of $
0.0001
per share.
Each share of common stock is entitled to
one
vote.
The holders of common stock are also entitled to receive dividends whenever funds are legally available and when declared by the Company’s board of directors. As of
September 30, 2025 and December 31, 2024
,
no
dividends have been declared to date.
On July 11, 2024, the Company completed an underwritten public follow-on offering. The offering consisted of
8,355,714
shares of common stock at an offering price to the public of $
35.00
per share, including
1,127,142
shares
of common stock upon the exercise in full of the overallotment option by the underwriters, as well as pre-funded
17
warrants
to purchase
285,715
shares of common stock at a public offering price of $
34.9999
per underlying share, in each case before underwriting discounts and commissions. Pursuant to the offering, the Company received aggregate gross proceeds of approximately $
302.4
million, before deducting underwriting discounts and commissions and other offering expenses, resulting in net proceeds of approximately $
283.8
million, after deducting underwriting discounts and commissions and other offering expenses.
As of
September 30, 2025, 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
July 11, 2024
None
$
0.0001
285,715
October 27, 2023
None
$
0.0001
319,150
April 27, 2023
None
$
0.0001
270,270
(1)
(1)
In September 2024,
1,750,000
shares of common stock subject to outstanding pre-funded warrants were
cashless exercised and
1,749,993
shares of common stock were issued.
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.
The Company had reserved common stock for future issuance as follows:
September 30,
December 31,
2025
2024
Exercise of outstanding options under the 2015, 2019 and 2023 Plans
11,325,082
7,737,595
Shares available for grant under the 2019 Plan
2,819,958
1,910,589
Shares available for grant under the 2023 Inducement Plan
1,426,467
593,592
Shares available under the Employee Stock Purchase Plan
2,727,556
1,911,011
Pre-funded warrants issued and outstanding
875,135
875,135
Total
19,174,198
13,027,922
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
1,000,000
shares of its common stock to be used exclusively for grants of awards to individuals who were not previously employees or directors of the Company as an inducement material to the individual’s entry into employment with the Company within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. The 2023 Inducement Plan was approved by the Company’s board of directors without stockholder approval in accordance with such rule. Options granted under the 2023 Inducement Plan have a term of
10 years
and generally vest over a
4-year
period with
1-year
cliff vesting.
In June 2024, the Company amended the 2023 Employment Inducement Award Plan, increasing the number of shares available for issuance by
1,000,000
.
In May 2025, the Company further amended the 2023 Employment Inducement Award Plan, increasing the number of shares available for issuance by
2,000,000
.
As of September 30, 2025, the number of shares available for issuance under the 2023 Inducement Plan was
1,426,467
.
18
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 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
4
% of the shares outstanding on the last day of the immediately preceding fiscal year, and such smaller number of shares as determined by the Company’s board of directors.
Options granted under the 2019 Plan have a term of
10
years (or
five years
if granted to a 10% stockholder) and generally vest over a
4
-year period with
1
-year cliff vesting.
As of September 30, 2025, the number of shares available for issuance under the 2019 Plan was
2,819,958
.
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
15
% of eligible compensation. The offering period is determined by the Company in its discretion but may not exceed
27
months. The per-share purchase price on the applicable exercise date for an offering period is equal to the lesser of
85
% of the fair market value of the common stock at either the first business day or last business day of the offering period, provided that no more than
4,000
shares of common stock may be purchased by any one employee during each offering period.
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
195,000
shares of common stock were initially reserved for issuance under the ESPP, subject to an annual increase on January 1 of each year, beginning on January 1, 2020, equal to the lesser of
1
% of the shares outstanding on the last day of the immediately preceding fiscal year and such smaller number of shares as may be determined by the Company’s board of directors, provided, however, that no more than
2,500,000
shares may be issued under the ESPP.
As of September 30, 2025, the number of shares available for issuance under the ESPP was
2,727,556
. For the three months ended September 30, 2025 and September 30, 2024, the Company recorded $
0.2
million and $
0.1
million, respectively, of compensation expense related to employee participation in the ESPP. For the
nine months ended September 30, 2025 and September 30, 2024, the Company recorded $
0.6
million and $
0.4
million, respectively.
19
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 September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Research and development
$
7,178
$
5,957
$
20,330
$
15,640
General and administrative
5,039
3,258
13,992
9,621
Total stock-based compensation expense
$
12,217
$
9,215
$
34,322
$
25,261
Stock Options
Activity under the Company’s 2015 and 2019 Plans and 2023 Inducement Plan is set forth below:
Outstanding Options
Shares
Weighted-
Average
Exercise
Price
Weighted-
Average
Remaining
Contractual
Term (Years)
Aggregate Intrinsic Value (Millions)
Balance, January 1, 2025
7,737,595
$
26.06
7.89
$
43.01
Options granted
4,039,358
$
20.54
Options exercised
(
130,409
)
$
15.47
Options canceled
(
278,998
)
$
26.98
Options expired
(
42,464
)
$
31.94
Balance, September 30, 2025
11,325,082
$
24.17
7.85
$
78.83
Exercisable as of September 30, 2025
4,768,974
$
22.05
6.65
$
43.19
Vested and expected to vest as of
September 30, 2025
11,325,082
$
24.17
7.85
$
78.83
The weighted-average grant-date fair value of options granted during the nine months ended September 30, 2025 and September 30, 2024 was $
14.18
and $
31.05
per share, respectively. The aggregate intrinsic value of options exercised for the nine months ended September 30, 2025 and September 30, 2024 was $
0.9
million and $
30.4
million, respectively. Intrinsic values are calculated as the difference between the exercise price of the underlying options and the fair value of the common stock on the date of exercise.
As of September 30, 2025 and December 31, 2024, total unrecognized stock-based compensation expense for stock options was $
108.4
million and $
90.2
million, respectively, which is expected to be recognized over a weighted-average period of
2.74
years and
2.63
years, respectively.
Black-Scholes Assumptions
The fair values of options were calculated using the assumptions set forth below:
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Expected term
6.1
years
6.1
years
5.5
-
6.1
years
5.5
-
6.1
years
Expected volatility
75.0
% -
75.4
%
77.8
% -
78.7
%
72.7
% -
76.3
%
77.8
% -
81.3
%
Risk-free interest rate
3.8
% -
4.1
%
3.6
% -
4.2
%
3.8
% -
4.4
%
3.6
% -
4.7
%
Dividend yield
0
%
0
%
0
%
0
%
20
Expected term
. The expected term represents the weighted-average period the stock options are expected to remain outstanding and is based on the options’ vesting terms and contractual terms.
Expected Volatility
. The expected volatility is based on the Company’s historical stock price volatility. The historical stock price volatility is calculated based on a period of time commensurate with the expected term assumption for each grant.
Risk-Free Interest Rate
. The risk-free rate assumption is based on U.S. Treasury instruments whose term was consistent with the expected term of the Company’s stock options.
Expected Dividend Rate
. The Company has not paid and does not anticipate paying any dividends in the near future. Accordingly, the Company has estimated the dividend yield to be
zero
.
The Company accounts for forfeitures as they occur.
Fair Value of Common Stock
The fair value of the Company’s common stock is determined based on the market price on the date of grant.
10. Significant Agreements
GSK Collaboration, Option and License Agreement
In June 2020, the Company entered into the Collaboration, Option and License Agreement (the “GSK Collaboration Agreement”), with an affiliate of GSK plc, GLAXOSMITHKLINE INTELLECTUAL PROPERTY (NO. 4) LIMITED (“GSK”), pursuant to which the Company and GSK have entered into a collaboration for its synthetic lethality programs targeting MAT2A, Pol Theta and Werner Helicase (“Werner” or “WRN”).
Pursuant to the GSK Collaboration Agreement, GSK paid the Company $
100.0
million on July 31, 2020. As of
September 30, 2025
, GSK has made aggregate payments in the amount of $
20.0
million for the achievement of certain development and regulatory milestones with respect to Pol Theta and WRN products.
GSK Collaboration - Pol Theta Program
Pursuant to the GSK Collaboration Agreement, GSK holds a global, exclusive license to develop and commercialize Pol Theta products arising out of the Pol Theta program. The Company and GSK collaborated on preclinical research for the Pol Theta program, and GSK is leading clinical development of IDE705 (GSK101) for the Pol Theta program. GSK is responsible for all research and development costs for the Pol Theta program.
In August 2023, the Company earned a $
7.0
million payment from GSK based on the acceptance of an IND for IDE705 (GSK101) by the FDA. An earlier $
3.0
million preclinical development milestone payment from GSK was earned in August 2022 in connection with ongoing IND-enabling studies to support the evaluation of IDE705 (GSK101).
The Company has the potential to achieve an additional $
10.0
million development milestone upon initiation of Phase 1 clinical dose expansion, as well as potential further aggregate late-stage development and regulatory milestones of up to $
465.0
million. Upon commercialization, the Company will be eligible to receive commercial milestones of up to $
475.0
million, and tiered royalties on global net sales of GSK101 – ranging from high single-digit to sub-teen double-digit percentages, subject to certain customary reductions.
GSK Collaboration - Werner Helicase Program
Pursuant to the GSK Collaboration Agreement, GSK holds a global, exclusive license to develop and commercialize WRN products arising out of the WRN program. The Company and GSK collaborated on preclinical research for the WRN program, and GSK is sponsoring and leading clinical development of IDE275 (GSK959) for the WRN program, with the Company responsible for
20
% and GSK responsible for
80
%
of such global research and
21
development
costs. The cost-sharing percentages will be adjusted based on the actual ratio of U.S. to global profits for WRN products, as measured three and six years after global commercial launch thereof.
In October 2024, the Company earned a $
7.0
million milestone payment from GSK based on the acceptance of an IND for IDE275 (GSK959) by the FDA. An earlier $
3.0
million preclinical development milestone payment from GSK was earned in October 2023 in connection with IND-enabling studies to support the evaluation of IDE275 (GSK959).
The Company has the potential to earn up to an additional $
10.0
million development milestone upon initiation of Phase 1 clinical dose expansion, as well as potential further aggregate late-stage development and regulatory milestones of up to $
465.0
million.
Upon commercialization, the Company will be eligible to receive commercial milestones of up to $
475.0
million,
50
% of U.S. net profits and tiered royalties on global non-U.S. net sales of the Werner Helicase Inhibitor DC – ranging from high single-digit to sub-teen double-digit percentages, subject to certain customary reductions.
Novartis License Agreement
In September 2018, the Company entered into a License Agreement with Novartis to develop and commercialize Novartis’ LXS196 (also known as IDE196), a Phase 1 protein kinase C (“PKC”) inhibitor, for the treatment of cancers having GNAQ and GNA11 mutations. The Company renamed Novartis’ LXS196 oncology as IDE196, and which has a non-proprietary name of darovasertib. Under the license agreement, Novartis granted to the Company a worldwide, exclusive, sublicensable license to research, develop, manufacture, and commercialize certain defined compounds and products, including IDE196 and certain other PKC inhibitors, as well as companion diagnostic products, collectively referred to as the licensed products, for any purpose. The Company paid Novartis an upfront payment of $
2.5
million and issued
263,615
shares of its Series B redeemable convertible preferred stock concurrently with the execution of the license agreement.
In March 2025, the FDA granted Breakthrough Therapy designation (“BTD”) for darovasertib, a potential first-in-class PKC inhibitor, for the neoadjuvant treatment of adult patients with primary uveal melanoma (“UM”) for whom enucleation has been recommended. Under the license agreement with Novartis, the Company paid Novartis a $
1.0
million milestone payment in April 2025.
Subject to completion of certain clinical and regulatory development milestones, the Company agreed to make additional milestone payments in the aggregate of up to $
8.0
million, and subject to achievement of certain commercial sales milestones, the Company agreed to make milestone payments in the aggregate of up to $
20.0
million. The Company also agreed to pay mid to high single-digit tiered royalty payments based on annual worldwide net sales of licensed products, payable on a licensed product-by-licensed product and country by country basis until the latest of the expiration of the last to expire exclusively licensed patent, the expiration of regulatory exclusivity, and the ten year anniversary of the first commercial sale of such product in such country. The royalty payments are subject to reductions for lack of patent coverage, loss of market exclusivity, and payment obligations for third-party licenses.
The Company owns or controls all commercial rights in its darovasertib program in UM, including in MUM and in primary UM, subject to certain economic obligations pursuant to its exclusive, worldwide license to darovasertib with Novartis.
Pfizer Clinical Trial Collaboration and Supply Agreements
In March 2020, the Company entered into a Clinical Trial Collaboration and Supply Agreement with Pfizer, Inc. (as amended in September 2020, April 2021, September 2021 and May 2023, the “Pfizer Agreement”). Pursuant to the Pfizer Agreement, Pfizer supplies the Company with their MEK inhibitor, binimetinib, and their cMET inhibitor, crizotinib, to evaluate combinations of darovasertib independently with each of the Pfizer compounds, in patients with tumors harboring activating GNAQ or GNA11 mutations. Under the Pfizer Agreement, the Company is the sponsor of the combination studies and will provide darovasertib and pay for the costs of the combination studies. Pfizer will provide binimetinib and crizotinib for use in the clinical trial at no cost to the Company. The Pfizer
22
Agreement provides that the Company and Pfizer will jointly own clinical data generated from the clinical trial and will also jointly own inventions, if any, relating to the combined use of darovasertib and binimetinib, or independently, to the combined use of darovasertib and crizotinib. The Company and Pfizer have formed a joint development committee responsible for coordinating all regulatory and other activities under the agreement.
In March 2022, the Company and Pfizer entered into a Second Clinical Trial Collaboration and Supply Agreement, as amended in May 2023 (the “Second Pfizer Agreement”), pursuant to which the Company is evaluating darovasertib and crizotinib as a combination therapy in MUM in a planned Phase 2/3 potential registration-enabling clinical trial. Pursuant to the Second Pfizer Agreement, the Company is the sponsor of the combination trial and the Company will provide darovasertib and pay for the costs of the combination trial, and Pfizer will provide crizotinib for the planned combination trial at no cost to the Company for up to an agreed-upon number of MUM patients. The Company and Pfizer will jointly own clinical data from the planned combination trial and all inventions relating to the combined use of darovasertib and crizotinib. The Company and Pfizer have formed a joint development committee responsible for coordinating all regulatory and other activities under the Second Pfizer Agreement.
Separately, in March 2022, the Company and Pfizer also entered into a Third Clinical Trial Collaboration and Supply Agreement (the “Third Pfizer Agreement”), pursuant to which the Company could, subject to preclinical validation and FDA feedback and guidance, evaluate darovasertib and crizotinib, as a combination therapy in cMET-driven tumors such as NSCLC and/or HCC in a Phase 1 clinical trial. Pursuant to the Third Pfizer Agreement, the Company was the sponsor of the planned combination trial, and the Company would provide darovasertib and pay for the costs of the combination trial. Pfizer would provide crizotinib for the planned combination trial at no cost to the Company. Pursuant to Amendment No. 1 to the Second Pfizer Agreement, as described below, the Company and Pfizer terminated the Third Pfizer Agreement.
In May 2023, the Company continued its relationship with Pfizer by entering into Amendment No. 4 to the Pfizer Agreement relating to the supply of crizotinib in support of this Phase 2 clinical trial, pursuant to which Pfizer will continue to provide the Company with an additional defined quantity of crizotinib at no cost.
Also, in May 2023, the Company expanded its relationship with Pfizer to support the Phase 2/3 registrational trial to evaluate darovasertib and crizotinib as a combination therapy in MUM by entering into Amendment No. 1 to the Second Pfizer Agreement. Under Amendment No. 1 to the Second Pfizer Agreement, Pfizer will provide the Company with a first defined quantity of crizotinib at no cost, as well as an additional second defined quantity of crizotinib at a lump-sum cost. The Third Pfizer Agreement was terminated by the Company and Pfizer under Amendment No. 1 to the Second Pfizer Agreement.
In December 2024, the Company entered into Amendment No. 5 to the Pfizer Agreement for the supply of crizotinib in the Phase 1/2 clinical trial for Pfizer to provide us a defined quantity of crizotinib at defined costs.
Cancer Research UK and University of Manchester Exclusive Option and License Agreement
The Company entered into an exclusive license under the Evaluation, Option and License Agreement with Cancer Research Technologies Ltd., also known as Cancer Research United Kingdom Ltd. (“CRT”), and the University of Manchester, pursuant to which the Company holds an exclusive worldwide license rights covering a broad class of PARG inhibitors.
In January 2022, the Company exercised its option for an exclusive worldwide license covering a broad class of poly (ADP-ribose) glycohydrolase (“PARG”), inhibitors from CRT, and the University of Manchester, and in connection therewith, paid a one-time option exercise fee of £
250,000
.
In April 2023, the Company incurred an obligation to pay milestone payments in an aggregate amount of £
750,000
to CRT based upon the achievement of certain milestones relating to first and second tumor histologies in connection with the Phase 1 portion of the IDE161-001 Phase 1/2 clinical trial in oncologic diseases.
The Company will be obligated to make additional payments to CRT aggregating up to £
18.75
million upon the achievement of specific development and regulatory approval events for development of a PARG inhibitor in oncologic diseases, including an aggregate of up to £
1.5
million and up to £
2.25
million
for the achievement of
23
certain
Phase 2 and Phase 3 development milestones, respectively, in each case as relating to first and second tumor histologies.
The Company will also pay low single-digit tiered royalties, and potentially also sales-based milestones, to CRT based on net sales of licensed products. In addition, in the event the Company sublicenses the intellectual property, it will also be obligated to pay CRT a specified percentage of any sublicense revenue.
Gilead Clinical Study Collaboration and Supply Agreement
In November 2023, the Company entered into a Clinical Study Collaboration and Supply Agreement with Gilead Sciences, Inc. (“Gilead”), (the “Gilead CSCSA”), to clinically evaluate IDE397 in combination with Trodelvy (sacituzumab govitecan-hziy), a Trop-2 directed antibody drug conjugate (“ADC”), in patients having MTAP-deletion urothelial cancer (“UC”), in a Phase 1 clinical trial.
In February 2025, the Company expanded its clinical study collaboration and entered into an additional Clinical Study Collaboration and Supply Agreement with Gilead (the “Second Gilead CSCSA”), to evaluate the IDE397 and Trodelvy combination in MTAP-deletion NSCLC.
The Company is the study sponsor and Gilead will provide the supply of Trodelvy. Gilead will bear internal or external costs incurred in connection with its supply of Trodelvy. The Company will bear all internal and external costs and expenses associated with the conduct of the combination study. The Company and Gilead each retain commercial rights to its respective compounds, including with respect to use as a monotherapy agent or combination agent.
Biocytogen Option and License Agreement
In July 2024, the Company entered into an Option and License Agreement (the “Biocytogen Option and License Agreement”), pursuant to which Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”), granted us an option for an exclusive worldwide license from Biocytogen to develop and commercialize products in connection with a potential first-in-class B7H3/PTK7 topoisomerase-I-inhibitor-payload BsADC program (the “Option”). Under the terms of the Biocytogen Option and License Agreement, the Company paid Biocytogen an upfront fee and an exercise fee totaling $
6.5
million upon exercise of the option. The Company is targeting an IND submission to the FDA in the second half of 2025 for IDE034, subject to satisfactory completion of ongoing preclinical and IND-enabling studies.
Biocytogen is eligible to receive additional development and regulatory milestone payments and commercial milestone payments, as well as low to mid single-digit royalties on net sales. Total potential milestone payments equal an aggregate of $
400.0
million, including development and regulatory milestone payments of up to $
100.0
million. The Company's royalty obligations continue with respect to each country and each product until the later of (i) the date on which such product is no longer covered by certain intellectual property rights in such country and (ii) the 10th anniversary of the first commercial sale of such product in such country.
Hengrui Pharma License Agreement
In December 2024, the Company entered into an exclusive License Agreement (the “Hengrui Pharma License Agreement”) with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui Pharma”), pursuant to which Hengrui Pharma granted the Company an exclusive worldwide license outside of Greater China, for IDE849 (SHR-4849), a potential first-in-class Phase 1 DLL3 TOP1i ADC. In April 2025, the Company received U.S. IND clearance for the initiation of a Phase 1 clinical trial to evaluate IDE849 in solid tumors.
Under the terms of the Hengrui Pharma License Agreement, Hengrui Pharma is eligible to receive upfront and milestone payments totaling $
1.045
billion, including a $
75.0
million upfront fee, up to $
200.0
million in development and regulatory milestone payments, plus commercial success-based milestones. Hengrui Pharma is also eligible to receive mid-single to low-double digit royalties on net sales outside of Greater China. The Company owns or controls all commercial rights outside of greater China for IDE849.
24
Servier License Agreement
In August 2025, the Company entered into an exclusive License Agreement (the “Servier License Agreement”) with Les Laboratoires Servier (“Servier”) pursuant to which the Company granted to Servier an exclusive license under certain intellectual property rights controlled by the Company relating to darovasertib to develop and commercialize products in all countries worldwide except for the United States for all diagnostic, prophylactic and therapeutic uses in humans.
Under the terms of the Servier License Agreement, Servier has paid an upfront payment of $
210.0
million to the Company, and the Company is eligible to receive development and regulatory milestone payments of up to an aggregate of $
100.0
million, commercial milestone payments of up to an aggregate of $
220.0
million, clinical trial cost sharing and clinical trial cost reimbursement, and double-digit royalties on net sales in all territories outside of the United States.
11. Revenue Recognition
The Company recognizes revenue in accordance with ASC 606 for the Servier License Agreement and the GSK Collaboration Agreement (see Note 10. Significant Agreements).
Servier License Agreement
:
In connection with the Servier License Agreement entered into in August 2025 (see Note. 10 Significant Agreements), the Company recognized $
207.8
million in collaboration revenue for the three and nine months ended September 30, 2025.
The Company identified the following performance obligations associated with the Servier License Agreement:
•
Development and commercialization license (the “D&C license”) for regulatory and commercial rights to darovasertib outside the US
•
Two research and development services for the development of the darovasertib program
The Company has determined the above performance obligations to be distinct due to the advanced clinical stage of darovasertib and availability of clinical data from multiple clinical trials.
The Company recognized revenue related to the D&C license performance obligation at a point in time during the three months ended September 30, 2025 upon execution of the contract. The Company recognizes revenue related to amounts allocated to research and development services over time, as the underlying services are performed over the period through the completion of program development activities. The timing of revenue recognition, billings, and cash collections results in accounts receivable, contract assets, and contract liabilities on the balance sheets.
Contract Balances
The following table presents the changes in the balance of contract liabilities during the three months ended
September 30, 2025 (in thousands):
Contract liabilities
Balance as of June 30, 2025
$
—
Cash received from upfront license payment
210,000
Reclassification to revenue, as the result of performance obligations satisfied
(
207,834
)
Balance as of September 30, 2025
$
2,166
Short-term contract liability
490
Long-term contract liability
1,676
Balance as of September 30, 2025
$
2,166
25
Transaction price allocated to the remaining performance obligations
At inception of the Servier License Agreement, the Company determined that the transaction price was $
351.0
million, including the upfront payment and the estimated reimbursable program costs. The remaining aggregated performance obligation as of September 30, 2025 was $
143.1
million, $
32.4
million of which is expected to be satisfied over the next
12 months
.
The following table presents the transaction price allocated to the remaining performance obligations as of September 30, 2025 (in thousands):
Remaining Performance Obligations
Allocation of Transaction Price
Research and Development Services
$
143,128
Total transaction price allocated to the remaining performance obligations
$
143,128
The Company will also recognize revenue from development and regulatory milestones as they are achieved.
The Company applies the sales-based royalty exception to the commercial milestones and tiered royalties for all programs. The Company will be entitled to receive the commercial milestones when the predefined net sales in a calendar year are achieved, upon which the variability will be resolved. Also, the Company will be entitled to receive the tiered royalties during a calendar year when global net sales of each product occur, upon which the variability will be resolved.
Significant Judgments
In applying ASC 606 to the Servier License Agreement, the Company made the following judgments that significantly affect the timing and amount of revenue recognition:
(i) Determination of the transaction price, including whether any variable consideration is included at inception of the contract
The transaction price is the amount of consideration that the Company expects to be entitled to in exchange for transferring promised goods or services to the customer. The transaction price is determined at inception of the contract and may include amounts of variable consideration. However, there is a constraint on inclusion of variable consideration in the transaction price if there is uncertainty at inception of the contract as to whether such consideration will be recognized in the future.
The decision as to whether or not it is probable that a significant reversal of revenue will occur in the future depends on the likelihood and magnitude of the reversal and is highly susceptible to factors outside the Company’s influence (for example, the Company cannot determine the outcome of clinical trials; the Company cannot determine if or when the counterparty will initiate or complete clinical trials; and the Company cannot determine if or when a regulatory agency provides any approval). In addition, the uncertainty is not expected to be resolved for a long period and the Company has limited experience in the field. Therefore, upon inception of the Servier License Agreement, development, regulatory and commercial milestones were fully constrained and were not included in the transaction price based on the factors noted above.
(ii) Determination of the standalone selling price of performance obligations
The Company allocates the transaction price to the performance obligations based upon their standalone selling prices. The standalone selling price is allocated to each performance obligation by the amount that the entity expects to receive for transferring the goods or services. Since evidence based on observable prices is not available for the performance obligations, the Company considered internally developed estimates, including those contemplated in negotiating the agreements, market conditions and entity-specific factors, in determining the standalone selling price using a discounted cash flow model adjusted for the probability of technical success where appropriate.
26
(iii) Determination of the method of allocation of the transaction price to the distinct performance obligations
The Company allocates the transaction price among performance obligations based on their relative selling prices, which are determined via the methodology described above.
(iv) Determination of the timing of satisfaction of performance obligations
The Company recognized revenue related to the D&C License performance obligation at the point in time when the license was delivered to Servier upon execution of the Servier License Agreement. The Company recognizes revenue from the research and development services for the development of the darovasertib program over time, as Servier simultaneously receives and consumes the benefits provided by the Company's performance. The Company measures its progress towards satisfaction of the research and development services based on the costs incurred as a percentage of the estimated total costs to be incurred to complete the performance obligations.
As the Company performs, it shares the results of its research and development studies with Servier through the joint development committee. Accordingly, the cost incurred method depicts the Company’s performance of the research and development services for the darovasertib program.
GSK Collaboration Agreement
:
Disaggregation of Revenue
The Company recognized
no
revenue related to the GSK Collaboration Agreement for the
three months ended September 30, 2025 and September 30, 2024
and
no
revenue for the
nine months ended September 30, 2025 and September 30, 2024.
The Company identified the following performance obligations associated with the GSK Collaboration Agreement:
(i) Preclinical and Phase 1 Monotherapy clinical research and development services under the MAT2A program (“MAT2A R&D Services”)
(ii) Preclinical research services and the related license to IDEAYA-owned technology under the Pol Theta program (“Pol Theta R&D Services”)
(iii) Preclinical research services and the related license to IDEAYA-owned technology under the WRN program (“WRN R&D Services”)
(iv) Material right associated with the option to license IDEAYA-owned technology under the MAT2A program (“Option”)
(v) Material right associated with the option to license to IDEAYA-owned technology under the MAT2A program to the extent necessary for preclinical activities in preparation for the MAT2A Combination Trial (“Preclinical MAT2A License”)
(vi) Material right associated with the supply of MAT2A product for the MAT2A Combination Trial (“MAT2A Supply”)
The Company completed all performance obligations related to the upfront payment under the GSK Collaboration Agreement as of December 31, 2023. Since December 31, 2023, the Company has no accounts receivable and no contract liabilities related to the GSK Collaboration Agreement. Because the Company completed all performance obligations, future collaboration revenue recognized under the GSK Collaboration Agreement is only related to milestone payments as they are earned.
In August 2023, the Company earned a $
7.0
million payment from GSK based on the acceptance of an IND for IDE705 (GSK101) by the FDA. An earlier $
3.0
million preclinical development milestone payment from GSK was earned in August 2022 in connection with ongoing IND-enabling studies to support the evaluation of IDE705 (GSK101). The Company has the potential to achieve an additional $
10.0
million
development milestone upon
27
initiation
of Phase 1 clinical dose expansion, as well as potential further aggregate late-stage development and regulatory milestones of up to $
465.0
million.
In October 2024, the Company earned a $
7.0
million milestone payment from GSK based on the acceptance of an IND for IDE275 (GSK959) by the FDA. An earlier $
3.0
million preclinical development milestone payment from GSK was earned in October 2023 in connection with IND-enabling studies to support the evaluation of IDE275 (GSK959). The Company has the potential to earn up to an additional $
10.0
million development milestone upon initiation of Phase 1 clinical dose expansion, as well as potential further aggregate late-stage development and regulatory milestones of up to $
465.0
million.
Significant Judgments
In applying ASC 606 to the GSK Collaboration Agreement, the Company made the following judgment that significantly affect the timing and amount of revenue recognition:
(i) Determination of the transaction price, including whether any variable consideration is included at inception of the contract
The transaction price is the amount of consideration that the Company expects to be entitled to in exchange for transferring promised goods or services to the customer. The transaction price must be determined at inception of a contract and may include amounts of variable consideration. However, there is a constraint on inclusion of variable consideration in the transaction price if there is uncertainty at inception of the contract as to whether such consideration will be recognized in the future.
The decision as to whether or not it is probable that a significant reversal of revenue will occur in the future, depends on the likelihood and magnitude of the reversal and is highly susceptible to factors outside the Company’s influence (for example, the Company cannot determine the outcome of clinical trials; the Company cannot determine if or when the counterparty will initiate or complete clinical trials; and the Company cannot determine if or when an regulatory agency provides any approval). In addition, the uncertainty is not expected to be resolved for a long period and finally, the Company has limited experience in the field. Therefore, at inception of the GSK Collaboration Agreement, development, regulatory and commercial milestones were fully constrained and were not included in the transaction price based on the factors noted above.
The Company constrains estimates of other variable consideration, such as reimbursable program costs, to amounts that are not expected to result in a significant revenue reversal in the future. The Company re-evaluates the transaction price, including the estimated variable consideration included in the transaction price and all constrained amounts, in each reporting period and as uncertain events are resolved or other changes in circumstances occur.
28
12. Net Income (Loss) Per Share Attributable to Common Stockholders
The following table sets forth the computation of basic and diluted net income (loss) per share attributable to common stockholders (in thousands, except share and per share data):
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
Numerator:
Net income (loss) attributable to common stockholders
$
119,244
$
(
51,821
)
$
(
30,425
)
$
(
144,165
)
Denominator:
Weighted-average common shares outstanding, basic
(1)
88,526,781
86,188,510
88,452,395
79,776,728
Effect of dilutive shares
1,164,097
—
—
—
Weighted-average shares used in computing net income (loss)
per share attributable to common stock, diluted
89,690,878
86,188,510
88,452,395
79,776,728
Net income (loss) per share attributable to common stockholders, basic
1.35
(
0.60
)
(
0.34
)
(
1.81
)
Net income (loss) per share attributable to common stockholders, diluted
$
1.33
$
(
0.60
)
$
(
0.34
)
$
(
1.81
)
(1) The shares underlying the pre-funded warrants to purchase shares of the Company’s common stock have been included in the
calculation of the weighted-average number of shares outstanding, basic and diluted, for the three and nine months ended September 30, 2025.
The following table summarizes potential shares of common stock that were excluded from the computation of diluted net income (loss) per share due to their anti-dilutive effect on those periods:
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
Options to purchase common stock
7,272,309
7,686,468
11,325,082
7,686,468
13. Segment Information
The Company operates and manages its business as
one
operating and reportable segment, which is the business of research and development for oncology-focused precision medicine. The Company’s chief operating decision maker (“CODM”) is its
President and CEO. The Company’s measure of segment profit or loss is net income. For purposes of evaluating performance and allocating resources, the CODM reviews the financial information and evaluates net income against comparable prior periods and the Company’s forecast. All of the Company's long-lived assets are located in the United States
.
In addition to the significant expense categories included within net income presented on the Company's condensed statements of operations and comprehensive loss, see below for disaggregated research and development expenses:
29
Three Months Ended
September 30, 2025
September 30, 2024
External clinical development expenses
(1)
:
Darovasertib
$
26,881
$
13,216
IDE397
(2)
3,699
5,062
IDE161
1,791
2,434
Personnel related and stock-based compensation
17,189
14,350
Other research and development expenses
(3)
33,433
22,090
Total research and development expenses
$
82,993
$
57,152
Nine Months Ended
September 30, 2025
September 30, 2024
External clinical development expenses
(1)
:
Darovasertib
$
74,989
$
28,112
IDE397
(2)
11,230
9,126
IDE161
5,807
4,493
Personnel related and stock-based compensation
50,205
41,138
Other research and development expenses
(3)
85,874
71,621
Total research and development expenses
$
228,105
$
154,490
(1) External clinical development expenses include manufacturing and clinical trial costs. These expenses are primarily for services
provided by external consultants, CMOs (“Contract Manufacturing Organizations”) and CROs (“Contract Research
Organizations”).
(2) IDE397 includes costs from the Amgen CTCSA.
(3) Other research and development expenses include manufacturing and clinical trial costs for preclinical and earlier clinical stage
programs. These expenses are primarily for services provided by external consultants, CMOs and CROs.
14. Subsequent Events
In October 2025, the Company triggered the first development milestone under the Hengrui Pharma License Agreement for IDE849 (DLL3 TOP1i ADC), which resulted in a $
2.0
million milestone payment to Hengrui Pharma.
30
Item 2. Management’s Discussion and Analysis o
f Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described, in or implied, by these forward-looking statements. Please also see the section of this Quarterly Report on Form 10-Q titled “Note Regarding Forward-Looking Statements.”
Overview
We are a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our clinical development strategy is to evaluate our product candidates in rational combinations, where appropriate, and earlier in the course of disease in the adjuvant and neoadjuvant settings which we believe has the potential to maximize their impact. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.
Our clinical pipeline currently consists of seven potential first-in-class product candidates, as follows:
•
Darovasertib
, an oral, small molecule inhibitor of protein kinase C is our most advanced program in development for uveal melanoma, or UM, an aggressive form of ocular cancer. We are evaluating darovasertib in combination with crizotinib, Pfizer’s oral c-MET inhibitor, for patients with metastatic UM. In October 2025 at the Society for Melanoma Research Congress in Amsterdam, Netherlands, we reported data from our single-arm Phase 2 trial (OptimUM-01) in patients with first-line, or 1L, metastatic UM, which included the first median overall survival data presented with the combination. We also expect to report topline data, including median progression free survival data, from our ongoing, potentially registration-enabling, Phase 2/3 trial (OptimUM-02) evaluating the combination of darovasertib and crizotinib in human leukocyte antigen-A*02:01 negative, or HLA-A2(-), patients with 1L metastatic UM by year-end 2025 to first quarter 2026. Based on our discussions with the U.S. Food and Drug Administration, or FDA, the data from OptimUM-02 may enable an accelerated approval filing.
We are also evaluating darovasertib as a single-agent in the neoadjuvant setting of primary UM, where the goal of treatment is to prevent enucleation (surgical eye removal), preserve vision prior to and post-plaque brachytherapy and potentially delay or prevent progression to metastatic disease. In October 2025 at the European Society for Medical Oncology Conference in Berlin, Germany, we presented updated data from more than 90 enucleation-eligible and plaque brachytherapy-eligible patients in our ongoing Phase 2 trial (OptimUM-09). We are currently conducting a randomized Phase 3 trial of darovasertib in the neoadjuvant setting of primary UM (OptimUM-10), which will enroll approximately 450 patients across two cohorts of plaque brachytherapy-eligible and enucleation-eligible patients. Target enrollment in this trial was revised downward from the prior estimate of 520 patients based on additional FDA feedback on the statistical plan (alpha usage) across the two cohorts.
In August 2025, we entered into an exclusive licensing agreement with Les Laboratoires Servier, or Servier, for the regulatory and commercial rights to darovasertib outside of the United States. We received an upfront payment of $210.0 million and are eligible for up to $320.0 million in development, regulatory and commercial-based milestone payments, as well as double-digit royalties on net sales in all territories outside of the United States. Servier will be responsible for the regulatory and commercial activities for darovasertib outside the United States. We and Servier will collaborate on the development of darovasertib and share the associated costs. We retain all rights to darovasertib in the United States.
31
•
IDE397
, a small molecule inhibitor of methionine adenosyltransferase 2a, or MAT2A, which we are developing for patients with solid tumors with methylthioadenosine phosphorylase, or MTAP, gene deletion. We are conducting a Phase 1/2 clinical trial pursuant to a Clinical Study Collaboration and Supply Agreement, or CSCSA, with Gilead to evaluate IDE397 in combination with Trodelvy (sacituzumab govitecan-hziy), Gilead’s Trop-2 directed antibody drug conjugate, or ADC, in patients with MTAP-deletion urothelial cancer, or UC, and non-small cell lung cancer, or NSCLC. We presented initial data from the combination in MTAP-deletion UC patients at our R&D Day on September 8, 2025 and are targeting to provide the next clinical data update at a medical conference in the first half of 2026.
•
IDE849
, a potential first-in-class DLL3 TOP1i ADC, is being evaluated by our partner, Hengrui Pharma, in a multi-site, open label Phase 1 clinical trial in China in small-cell lung cancer, or SCLC, patients. Clinical efficacy and safety data from over 70 patients was presented by Hengrui at the International Association for the Study of Lung Cancer (IASLC) 2025 World Conference on Lung Cancer taking place from September 6 to September 9, 2025 in Barcelona, Spain. In May 2025 we initiated a global Phase 1 trial of IDE849 and have achieved first-patient-in (FPI) in the United States. We continue to enroll patients with SCLC and plan to expand into patients with neuroendocrine tumors (NETs) and other DLL3-expressing tumors by the end of 2025.
•
IDE161
, a potential first-in-class small molecule poly-(ADP-ribose) glycohydrolase, or PARG, inhibitor is continuing with Phase 1 dose optimization to inform future combination studies with IDE849 and other TOP1i-based ADCs where PARG inhibition may synergize with the payload to deepen responses. We plan to initiate a Phase 1 combination trial of IDE849 and IDE161 by the end of 2025.
•
IDE275/GSK959
, a potential first-in-class small molecule inhibitor of Werner Helicase, is being developed in collaboration with GlaxoSmithKline, or GSK. A Phase 1 clinical trial in patients with MSI-High solid tumors is ongoing.
•
IDE705/GSK101
, a potential first-in-class small molecule inhibitor of DNA Polymerase Theta Helicase, or Pol Theta, is being developed in collaboration with GSK. A Phase 1 clinical trial in combination with niraparib, GSK’s small molecule inhibitor of PARP, is ongoing in patients with BRCA+ or other HRD-positive tumors. We are targeting Phase 2 expansion in HRD-positive solid tumors, which would trigger a $10 million milestone payment from GSK.
•
IDE892,
a potential best-in-class MTA-cooperative inhibitor of PRMT5, is being developed for patients with MTAP-deleted lung cancer and other high priority MTAP-deleted solid tumor indications. We received an investigational new drug, or IND, clearance from the FDA in the third quarter and expect to begin a Phase 1 dose escalation trial by the end of the year with the goal of advancing into combination trials with IDE397 in the first half of 2026.
In addition to our clinical stage pipeline, we are advancing two pre-clinical development programs:
•
IDE034
, a potential first-in-class B7H3/PTK7 bispecific TOP1i ADC, for which an investigational new drug application (IND) was submitted in the fourth quarter; and
•
IDE574
, a potential first-in-class KAT6/7 dual inhibitor, which is on track for IND submission by the end of the year.
Since our inception, we have invested significantly in capabilities for identifying and validating new precision medicine targets and biomarkers for patient selection and have established multiple research collaborations to support our internal discovery and development efforts. We have also partnered with leading pharmaceutical companies, including GSK, Pfizer and Gilead to support clinical development activities for our pipeline programs.
Corporate Update
We do not have any products approved for sale and have not generated any product revenue since inception. We have funded our operations primarily through the sale and issuance of common stock and the upfront payment and certain milestone payments received from GSK and Servier. As of September 30, 2025, we had cash, cash equivalents and marketable securities of approximately $1.14 billion, consisting primarily of money market funds, U.S. government securities, commercial paper and corporate bonds.
Since our inception in June 2015, we have devoted substantially all of our resources to discovering and developing our product candidates. We have incurred significant operating losses to date and expect that our operating expenses
32
will increase significantly as we advance our product candidates through preclinical and clinical development; seek regulatory approval, and prepare for, and, if approved, proceed to commercialization; acquire, discover, validate and develop additional product candidates; obtain, maintain, protect and enforce our intellectual property portfolio; and hire additional personnel. For information about our specific program costs and expenses, see Note 10. Significant Agreements.
Our net losses were $30.4 million and $144.2 million for the nine months ended September 30, 2025 and September 30, 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $653.3 million.
Our ability to generate product revenue will depend on the successful development, regulatory approval and eventual commercialization of one or more of our product candidates, ourselves, or for some programs, in collaboration with our strategic partners.
Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of our product candidates.
As of September 30, 2025, we had cash, cash equivalents and short-term and long-term marketable securities of approximately $1.14 billion.
We believe that our cash, cash equivalents, and short-term and long-term marketable securities will be sufficient to fund our planned operations for at least twelve months from the date of the issuance of our Quarterly Report on Form 10-Q filed on November 4, 2025.
These funds will support our efforts through potential achievement of multiple preclinical and clinical milestones across multiple programs.
Components of Operating Results
Collaboration Revenues
To date, we have not generated any revenue from product sales, and we do not expect to generate any revenue from product sales unless and until we are able to initiate a registrational clinical trial, obtain regulatory approval and commercialize one of our product candidates in the future. Our revenue consists exclusively of collaboration revenue under the GSK Collaboration Agreement and Servier License Agreement, including amounts that are recognized related to previously received upfront payments, development milestone payments and amounts due and payable to us for research and development services.
The amount of revenue recognized related to the GSK Collaboration Agreement, including as related to the previously received upfront payment or to certain development milestone payments, may vary considerably by period and certain components thereof may generally decrease year-over-year as we satisfy remaining performance obligations, for example, relating to the Pol Theta and WRN R&D Services. Since December 31, 2023, we have fully recognized the contract liabilities related to the upfront payment and reimbursements for the research and development performance obligations under the GSK Collaboration Agreement. There are no remaining contract liabilities as of September 30, 2025 as we concluded all the research and development performance obligations under the GSK Collaboration Agreement. The future revenue recognition is contingent on additional milestones earned, profit sharing and royalties on any net product sales under our collaborations. We expect that any revenue we recognize or generate under the GSK Collaboration Agreement will fluctuate from period to period due to period to period variability in milestone payments and other payments.
In August 2025, the Company entered into the Servier License Agreement for development and commercial rights to darovasertib in all countries worldwide except for the United States. The Company recognized revenue related to the D&C license performance obligation at a point in time during the three months ended September 30, 2025 upon execution of the contract. The Company recognizes revenue related to amounts allocated to research and development services over time, as the underlying services are performed over the period through the completion of program development activities. The timing of revenue recognition, billings, and cash collections results in accounts receivable, contract assets, and contract liabilities on the balance sheets.
33
The Company will also recognize revenue from development and regulatory milestones as they are achieved. Future net product sales may also result in royalty payments.
When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract asset or contract liability is recorded. Contract liabilities are derecognized as revenue after control of the products or services is transferred to the customer and all revenue recognition criteria have been met.
Operating Expenses
Research and Development Expenses
Substantially all of our research and development expenses consist of expenses incurred in connection with the discovery and development of our product candidates. These expenses include certain payroll and personnel-related expenses, including salaries, employee benefit costs and stock-based compensation expenses for our research and product development employees, fees to third parties to conduct certain research and development activities on our behalf including fees to CMOs and CROs in support of manufacturing and clinical activity for darovasertib, IDE397, IDE849, IDE161, IDE275 / GSK959, IDE705 / GSK 101 and IDE892, and consulting costs, costs for laboratory supplies, costs for product licenses and allocated overhead, including rent, equipment, depreciation, information technology costs and utilities. We expense both internal and external research and development expenses as they are incurred.
We have entered into various agreements with CMOs and CROs. Our research and development accruals are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs. The estimated costs of research and development provided, but not yet invoiced, are included in accrued liabilities on the condensed balance sheet. If the actual timing of the performance of services or the level of effort varies from the original estimates, we will adjust the accrual accordingly. Payments made to CMOs and CROs under these arrangements in advance of the performance of the related services are recorded as prepaid expenses and other current assets until the services are rendered.
Costs of certain activities, such as preclinical studies, are generally recognized based on an evaluation of the progress to completion of specific tasks. Nonrefundable payments made prior to the receipt of goods or services that will be used or rendered for future research and development activities are deferred and capitalized as prepaid expenses and other current assets on our condensed balance sheet. The capitalized amounts are recognized as expense as the goods are delivered or the related services are performed.
We do not allocate our internal costs by product candidate, including internal costs, such as payroll and other personnel expenses, laboratory supplies and allocated overhead. With respect to internal costs, several of our departments support multiple product candidate research and development programs, and therefore the costs cannot be allocated to a particular product candidate or development program. The following table summarizes our external clinical development expenses by program:
Three Months Ended
September 30, 2025
June 30, 2025
External clinical development expenses
(1)
:
Darovasertib
$
26,881
$
25,091
IDE397
(2)
3,699
3,790
IDE161
1,791
1,568
Personnel related and stock-based compensation
17,189
17,201
Other research and development expenses
(3)
33,433
26,576
Total research and development expenses
$
82,993
$
74,226
34
Nine Months Ended
September 30, 2025
September 30, 2024
External clinical development expenses
(1)
:
Darovasertib
$
74,989
$
28,112
IDE397
(2)
11,230
9,126
IDE161
5,807
4,493
Personnel related and stock-based compensation
50,205
41,138
Other research and development expenses
(3)
85,874
71,621
Total research and development expenses
$
228,105
$
154,490
(1)
External clinical development expenses include manufacturing and clinical trial costs. These expenses are primarily for services provided by external consultants, CMOs and CROs.
(2)
IDE397 includes costs from Amgen CTCSA.
(3)
Other research and development expenses include manufacturing and clinical trial costs for preclinical and earlier clinical stage programs. These expenses are primarily for services provided by external consultants, CMOs and CROs.
We are focusing substantially all of our resources on the development of our product candidates. We expect our research and development expenses to increase substantially during the next few years, as we seek to initiate and/or advance clinical trials for our product candidates, complete our clinical program, pursue regulatory approval of our product candidates and prepare for a possible commercial launch. Predicting the timing or the cost to complete our clinical program or validation of our commercial manufacturing and supply processes is difficult and delays may occur because of many factors, including factors outside of our control. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development. Furthermore, we are unable to predict when or if our product candidates will receive regulatory approval with any certainty.
General and Administrative Expenses
General and administrative expenses consist primarily of payroll and personnel-related expenses, including salaries, employee benefit costs and stock-based compensation expense, professional fees for legal, patent, consulting, accounting and tax services, allocated overhead, including rent, equipment, depreciation, information technology costs and utilities, and other general operating expenses not otherwise classified as research and development expenses.
We anticipate that our general and administrative expenses will increase, as a result of increased personnel costs, including salaries, benefits and stock-based compensation expense, patent costs for our product candidates, expanded infrastructure and higher consulting, legal and accounting services associated with maintaining compliance with our Nasdaq stock exchange listing and requirements of the Securities and Exchange Commission, or the SEC, investor relations costs and director and officer insurance policy premiums associated with being a public company.
Other Income
Interest Income and Other Income, Net
Interest income and other income, net consists primarily of interest income earned on our cash, cash equivalents and marketable securities.
Results of Operations
A discussion regarding our financial condition and results of operations for the three months ended September 30, 2025 compared to the three months ended June 30, 2025 and the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 is presented below.
35
Comparison of Three Months Ended September 30, 2025 and June 30, 2025
The following table summarizes our results of operations for the periods indicated (in thousands):
Three Months Ended
September 30, 2025
June 30, 2025
Change
% Change
Revenue:
Collaboration revenue
$
207,834
—
$
207,834
100
%
Operating expenses:
Research and development
82,993
74,226
8,767
12
%
General and administrative
16,389
14,580
1,809
12
%
Income (loss) from operations
108,452
(88,806
)
197,258
222
%
Interest income and other income, net
10,792
11,315
(523
)
(5
%)
Net income (loss)
$
119,244
$
(77,491
)
$
196,735
254
%
Collaboration Revenue
Collaboration Revenue was $207.8 million for the three months ended September 30, 2025 as a result of revenue recognized from the Servier License Agreement. See Note 11. Revenue Recognition.
Research and Development Expenses
Research and development expenses increased by $8.8 million, or 12%, during the three months ended September 30, 2025 compared to the three months ended June 30, 2025 primarily due to $8.8 million in fees paid to CROs, CMOs, and consultants related to the advancement of our lead product candidates through preclinical and clinical studies.
General and Administrative Expenses
General and administrative expenses increased by $1.8 million, or 12%, during the three months ended September 30, 2025 compared to the three months ended June 30, 2025. The increase in general and administrative expense was primarily due to $1.8 million in consulting and legal patent expenses to support our growth.
Interest Income and Other Income, Net
Interest income decreased by $0.5 million, or 5%, during the three months ended September 30, 2025 compared to the three months ended June 30, 2025 primarily due to lower interest rates.
36
Comparison of Nine Months Ended September 30, 2025 and September 30, 2024
The following table summarizes our results of operations for the periods indicated (in thousands):
Nine Months Ended
September 30, 2025
September 30, 2024
Change
% Change
Revenue:
Collaboration revenue
$
207,834
—
$
207,834
100
%
Operating expenses:
Research and development
228,105
154,490
73,615
48
%
General and administrative
44,472
28,347
16,125
57
%
Loss from operations
(64,743
)
(182,837
)
118,094
65
%
Interest income and other income, net
34,318
38,672
(4,354
)
(11
%)
Net loss
$
(30,425
)
$
(144,165
)
$
113,740
79
%
Collaboration Revenue
Collaboration Revenue was $207.8 million for the nine months ended September 30, 2025 as a result of revenue recognized from the Servier License Agreement. See Note 11. Revenue Recognition.
Research and Development Expenses
Research and development expenses increased by $73.6 million, or 48%, during the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 primarily due to $59.4 million in fees paid to CROs, CMOs, and consultants related to the advancement of our lead product candidates through preclinical and clinical studies, $9.0 million in personnel-related expenses and $5.2 million in costs for laboratory supplies, facilities and software license costs to support our research and development programs.
General and Administrative Expenses
General and administrative expenses increased by $16.1 million, or 57%, during the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 primarily due to increases in $8.4 million in personnel-related expenses and $7.7 million in consulting services and legal patent expenses to support our growth.
Interest Income and Other Income, Net
Interest income decreased by $4.4 million, or 11%, during the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 primarily due to lower interest rates.
Liquidity and Capital Resources; Plan of Operations
Sources of Liquidity
We have funded our operations primarily through the sale and issuance of common stock and the upfront payment and certain milestone payments received from GSK and Servier. As of September 30, 2025, we had cash, cash equivalents and marketable securities of approximately $1.14 billion, consisting primarily of money market funds, U.S. government securities, commercial paper, and corporate bonds.
On January 19, 2024, we entered into a new Open Market Sales Agreement, or the January 2024 Sales Agreement, with Jefferies LLC, or Jefferies, relating to an at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of common stock, par value $0.0001 per share, or common stock, having aggregate gross proceeds of up to $350.0 million through Jefferies as sales agent.
37
During the nine months ended September 30, 2025, we sold an aggregate of 984,000 shares of our common stock for an aggregate net proceeds of $25.0 million at a weighted average sales price of approximately $26.00 per share under the at-the-market offering pursuant to the January 2024 Sales Agreement with Jefferies as sales agent. As of September 30, 2025, approximately $156.6 million of common stock remained available to be sold pursuant to the January 2024 Sales Agreement.
The Company may cancel its at-the-market program at any time upon written notice, pursuant to its terms.
Material Cash Requirements
We have primarily incurred net losses since our inception. For the nine months ended September 30, 2025 and September 30, 2024, we had net losses of $30.4 million and $144.2 million, respectively, and we expect to incur substantial additional losses in future periods. As of September 30, 2025, we had an accumulated deficit of $653.3 million. Based on our current business plan, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operations for at least the next 12 months from the issuance date of this Quarterly Report on Form 10-Q.
To date, we have not generated any product revenue. We do not expect to generate any meaningful product revenue unless and until we obtain regulatory approval of and commercialize any of our product candidates, and we do not know when, or if, it will occur. We expect to continue to incur significant losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for our product candidates, and begin to commercialize any approved products. We are subject to all of the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. Moreover, we expect to incur additional costs associated with operating as a public company.
We will continue to require additional capital to develop our product candidates and fund operations for the foreseeable future. We may seek to raise capital through private or public equity or debt financings, collaboration or other arrangements with corporate sources, or through other sources of financing. Adequate additional funding may not be available to us on acceptable terms or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategies. We anticipate that we will need to raise substantial additional capital, the requirements for which will depend on many factors, including:
•
the scope, timing, rate of progress and costs of our drug discovery, preclinical development activities, laboratory testing and clinical trials for our product candidates;
•
the number and scope of clinical programs we decide to pursue;
•
the scope and costs of manufacturing development and commercial manufacturing activities;
•
the extent to which we acquire or in-license other product candidates and technologies;
•
the cost, timing and outcome of regulatory review of our product candidates;
•
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
•
our ability to establish and maintain collaborations on favorable terms, if at all;
•
our efforts to enhance operational systems and our ability to attract, hire and retain qualified personnel, including personnel to support the development of our product candidates;
•
the costs associated with being a public company; and
•
the cost and timing associated with commercializing our product candidates if they receive marketing approval.
A change in the outcome of any of these or other variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, our operating plans may change in the future, and we will continue to require additional capital to meet operational needs and capital requirements associated with such operating plans. If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing
38
into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments or engage in certain merger, consolidation or asset sale transactions.
Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. If we are unable to raise additional funds when needed, we may be required to delay, reduce, or terminate some or all of our development programs and clinical trials. We may also be required to sell or license to others rights to our product candidates in certain territories or indications that we would prefer to develop and commercialize ourselves.
We enter into contracts in the normal course of business with third-party contract organizations for preclinical and clinical studies and testing, manufacture and supply of our preclinical and clinical materials and providing other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice, and therefore, we believe that our non-cancellable obligations under these agreements are not material.
For more information see Notes 5. Operating Leases, 6. Commitments and Contingencies, 7. Income Taxes and 10. Significant Agreements, each in the unaudited interim condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
Adequate additional funding may not be available to us on acceptable terms or at all.
See the section of this Quarterly Report on Form 10-Q titled “Part I, Item 1A. – Risk Factors” for additional risks associated with our substantial capital requirements.
Off-Balance Sheet Arrangements
We have not entered into any off-balance sheet arrangements as defined in the rules and regulations of the SEC.
Summary Statement of Cash Flows
The following table sets forth the primary sources and uses of cash, cash equivalents, and restricted cash for each of the periods presented below (in thousands):
Nine Months Ended September 30,
2025
2024
Net cash provided by (used in):
Operating activities
$
19,398
$
(125,929
)
Investing activities
167,502
(305,450
)
Financing activities
27,649
674,798
Net increase in cash, cash equivalents and restricted cash
$
214,549
$
243,419
Cash Flows from Operating Activities
Net cash provided by operating activities was $19.4 million for the nine months ended September 30, 2025. Cash provided by operating activities was primarily due to the use of funds in our operations to develop our product candidates, partially offset by the upfront payment from Servier License Agreement resulting in a net loss of $30.4 million, adjusted for net non-cash charges of $29.3 million and changes in net operating assets and liabilities of $20.6 million. Our non-cash charges consisted of $34.3 million in stock-based compensation, $2.0 million in depreciation and $1.4 million of the amortization of right of use assets, partially offset by $8.5 million accretion of discounts on marketable securities. The net change in our operating assets and liabilities consisted primarily due to cash inflows from $3.6 million in accounts payable, $15.2 million accrued and other liabilities in support of the advancement of our lead product candidates, $2.2 million in contract liabilities related to the Servier License Agreement, $1.9 million in lease liabilities, partially offset by outflows of $2.3 million in prepaid and other assets.
Net cash used in operating activities was $125.9 million for the nine months ended September 30, 2024. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $144.2 million, adjusted for net non-cash charges of $10.1 million and changes in net
39
operating assets and liabilities of $8.1 million. Our non-cash charges consisted of $25.3 million in stock-based compensation, $1.8 million in depreciation and $1.4 million of the amortization of right of use assets, partially offset by $18.3 million accretion of discounts on marketable securities. The net change in our operating assets and liabilities consisted primarily due to cash inflows from $5.3 million in accounts payable and $8.5 million accrued and other liabilities due to CRO fees in support of research and manufacturing activities, partially offset by outflows of $4.4 million in prepaid and other assets and $1.3 million in lease liabilities.
Cash Flows from Investing Activities
Net cash provided by investing activities was $167.5 million for the nine months ended September 30, 2025, which consisted primarily of $371.8 million used to purchase marketable securities and $2.0 million used to purchase property and equipment, offset by $541.3 million provided by maturities of marketable securities.
Net cash used in investing activities was $305.5 million for the nine months ended September 30, 2024, which consisted primarily of $854.3 million used to purchase marketable securities and $2.8 million used to purchase property and equipment, partially offset by $551.6 million provided by maturities of marketable securities.
Cash Flows from Financing Activities
Net cash provided by financing activities was $27.6 million for the nine months ended September 30, 2025, which consisted primarily of $24.9 million in net proceeds from at-the-market offerings, $1.9 million in proceeds from exercise of common stock options and $0.8 million in proceeds from ESPP purchases.
Net cash provided by financing activities was $674.8 million for the nine months ended September 30, 2024, which consisted primarily of $379.9 million of net proceeds from at-the-market offerings, $274.7 million of proceeds from issuance of common stock upon public offering, $9.4 million of proceeds from issuance of pre-funded warrants, $10.0 million of proceeds from exercise of common stock options and $0.8 million of proceeds from ESPP purchases.
Critical Accounting Policies
Our financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported revenue recognized and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
For more detail on our critical accounting policies, refer to Note 2 in the unaudited interim condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, and the notes to the financial statements appearing elsewhere in our Annual Report on Form 10-K filed with the SEC on February 18, 2025. For the nine months ended September 30, 2025, there were no material changes to our critical accounting policies from those disclosed in our Annual Report on Form 10-K filed with the SEC on February 18, 2025.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Interest Rate Sensitivity
The market risk inherent in our financial instruments and in our financial position represents the potential loss arising from adverse changes in interest rates or exchange rates. As of September 30, 2025, we had cash, cash equivalents and marketable securities of approximately $1.14 billion, consisting of bank deposits, interest-bearing money market funds, investments in U.S. government securities, commercial paper and corporate bonds, for which the fair value would be affected by changes in the general level of U.S. interest rates. Even if the fair value of certain government securities, commercial paper, and corporate bonds is affected by changes in U.S. interest rates, the principal of such instruments will be due to us upon maturity.
The primary objective of our investment activities is to preserve capital to fund our operations. We also seek to maximize income from our investments without assuming significant risk. Because our investments are primarily short-term in duration and our holdings in U.S. government treasury bonds mature prior to our expected need for liquidity, we believe that our exposure to interest rate risk is not significant.
While we have seen higher inflation in the past few years, we do not believe that inflation, or exchange rate fluctuations have had a significant impact on our results of operations for any periods presented herein.
Item 4. Controls
and Procedures.
Limitations on Effectiveness of Controls and Procedures
In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Principal Executive Officer and Principal Financial Officer, evaluated, as of the end of the period covered by this Quarterly Report on Form 10-Q, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based on that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of September 30, 2025.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(e) and 15d-15(e) of the Exchange Act that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II—OTHER
INFORMATION
Item 1. Legal Proceedings.
From time to time, we may become involved in litigation or other legal proceedings. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors.
In addition to other information contained elsewhere in this Quarterly Report on Form 10-Q, you should carefully consider the risk factors discussed in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K filed with the SEC on February 18, 2025, or our Annual Report, which could materially affect our business, financial condition, or future results. As of the date of this Quarterly Report on Form 10-Q, there have been no material changes to the risk factors disclosed in our Annual Report.
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Item 2. Unregistered Sales of Equi
ty Securities and Use of Proceeds.
Unregistered Sales of Equity Securities
None.
Use of Proceeds from the Sale of Registered Securities
Not applicable.
Issuer Purchases of Equity Securities
None.
Item 3. Defaults Upo
n Senior Securities.
Not applicable.
Item 4. Mine Saf
ety Disclosures.
Not applicable.
Item 5. Other information.
Trading Plans
During the three months ended September 30, 2025
, no Section 16 officers or directors
adopted
or
terminated
contracts, instructions or written plans for the purchase or sale of our securities.
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† Certain information in this exhibit has been excluded pursuant to Regulation S-K, Item 601(b)(10).
* The certification attached as Exhibit 32.1 that accompanies this Quarterly Report on Form 10-Q is not deemed filed with the SEC and is not to be incorporated by reference into any filing of IDEAYA Biosciences, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-Q, irrespective of any general incorporation language contained in such filing.
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SIGNA
TURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereto duly authorized.
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