Item 1. Financial Statements
Item 1. Financial Statements
RIGEL PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEET S
(In thousands)
As of
September 30, 2025
December 31, 2024 (1)
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
48,534
$
56,746
Short-term investments
88,609
20,575
Accounts receivable, net
45,925
41,615
Inventories
13,303
6,002
Prepaid and other current assets
18,556
10,165
Total current assets
214,927
135,103
Property and equipment, net
54
92
Intangible assets, net
25,336
27,100
Operating lease right-of-use assets
1,050
246
Other assets
1,167
1,435
Total assets
$
242,534
$
163,976
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$
3,846
$
3,339
Accrued compensation
10,065
10,139
Accrued research and development
4,816
4,073
Acquisition-related liabilities
5,000
—
Revenue reserves and refund liability
30,020
26,440
Loans payable, net, current portion
29,761
7,272
Other accrued liabilities
8,943
10,396
Deferred revenue
1,355
1,355
Lease liabilities, current portion
594
285
Total current liabilities
94,400
63,299
Acquisition-related liabilities
—
5,000
Long-term portion of lease liabilities
556
—
Long-term portion of loans payable, net
29,969
52,408
Other long-term liabilities
—
39,981
Total liabilities
124,925
160,688
Commitments
Stockholders’ equity:
Common stock
18
18
Additional paid-in capital
1,408,601
1,393,325
Accumulated other comprehensive income
96
10
Accumulated deficit
( 1,291,106 )
( 1,390,065 )
Total stockholders’ equity
117,609
3,288
Total liabilities and stockholders’ equity
$
242,534
$
163,976
(1) The balance sheet as of December 31, 2024 has been derived from the audited financial statements included in Rigel’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) on March 4, 202 5.
See Accompanying Notes to Condensed Financial Statements
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RIGEL PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATION S
(In thousands, except per share amounts)
(unaudited)
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Revenues:
Product sales, net
$
64,067
$
38,927
$
166,565
$
98,380
Contract revenues from collaborations
5,395
16,380
57,915
23,302
Total revenues
69,462
55,307
224,480
121,682
Costs and expenses:
Cost of product sales
4,753
8,026
13,666
12,858
Research and development
7,353
6,182
22,610
17,748
Selling, general and administrative
28,936
27,043
85,908
83,539
Total costs and expenses
41,042
41,251
122,184
114,145
Income from operations
28,420
14,056
102,296
7,537
Interest income
1,094
425
2,438
1,570
Interest expense
( 1,894 )
( 2,060 )
( 5,621 )
( 5,963 )
Income before income taxes
27,620
12,421
99,113
3,144
(Benefit from) provision for income taxes
( 280 )
—
154
—
Net income
$
27,900
$
12,421
$
98,959
$
3,144
Net income per share
Basic
$
1.55
$
0.71
$
5.52
$
0.18
Diluted
$
1.46
$
0.70
$
5.38
$
0.18
Weighted average shares used in computing net income per share
Basic
18,038
17,600
17,912
17,556
Diluted
19,156
17,648
18,379
17,599
See Accompanying Notes to Condensed Financial Statements
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RIGEL PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF COMPREHENSIVE INCOME
(In thousands)
(unaudited)
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Net income
$
27,900
$
12,421
$
98,959
$
3,144
Other comprehensive income:
Net unrealized income on short-term investments
90
20
86
3
Comprehensive income
$
27,990
$
12,441
$
99,045
$
3,147
See Accompanying Notes to Condensed Financial Statements
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RIGEL PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF STOCK HOLDERS’ EQUITY (DEFICIT)
(In thousands, except share amounts)
(unaudited)
Additional
Accumulated Other
Total
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Capital
Income (Loss)
Deficit
Equity
Balance as of January 1, 2025
17,710,216
$
18
$
1,393,325
$
10
$
( 1,390,065 )
$
3,288
Net income
—
—
—
—
11,446
11,446
Net change in unrealized loss on short-term investments
—
—
—
( 12 )
—
( 12 )
Issuance of common stock upon exercise of options, net of shares withheld
30,892
—
484
—
—
484
Issuance of common stock upon vesting of restricted stock units (RSUs)
125,783
—
—
—
—
—
Stock-based compensation expense
—
—
3,361
—
—
3,361
Balance as of March 31, 2025
17,866,891
18
1,397,170
( 2 )
( 1,378,619 )
18,567
Net income
—
—
—
—
59,613
59,613
Net change in unrealized gain on short-term investments
—
—
—
8
—
8
Issuance of common stock upon exercise of options, net of shares withheld, and participation in Purchase Plan
52,295
—
418
—
—
418
Issuance of common stock upon vesting of RSUs
17,908
—
—
—
—
—
Stock-based compensation expense
—
—
3,328
—
—
3,328
Balance as of June 30, 2025
17,937,094
18
1,400,916
6
( 1,319,006 )
81,934
Net income
—
—
—
27,900
27,900
Net change in unrealized gain on short-term investments
—
—
—
90
—
90
Issuance of common stock upon exercise of options
206,890
—
4,271
—
—
4,271
Stock-based compensation expense
—
—
3,414
—
—
3,414
Balance as of September 30, 2025
18,143,984
$
18
$
1,408,601
$
96
$
( 1,291,106 )
$
117,609
Additional
Accumulated Other
Total
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Capital
Income (Loss)
Deficit
(Deficit)
Balance as of January 1, 2024
17,482,513
$
17
$
1,378,881
$
8
$
( 1,407,550 )
$
( 28,644 )
Net loss
—
—
—
—
( 8,247 )
( 8,247 )
Net change in unrealized loss on short-term investments
—
—
—
( 13 )
—
( 13 )
Issuance of common stock upon exercise of options
9,066
—
89
—
—
89
Issuance of common stock upon vesting of RSUs
48,658
—
—
—
—
—
Stock-based compensation expense
—
—
5,144
—
—
5,144
Balance as of March 31, 2024
17,540,237
17
1,384,114
( 5 )
( 1,415,797 )
( 31,671 )
Net loss
—
—
—
—
( 1,030 )
( 1,030 )
Net change in unrealized loss on short-term investments
—
—
—
( 4 )
—
( 4 )
Issuance of common stock upon exercise of options and participation in Purchase Plan
36,130
—
252
—
—
252
Issuance of common stock upon vesting of RSUs
17,750
—
—
—
—
—
Stock-based compensation expense
—
—
2,539
—
—
2,539
Balance as of June 30, 2024
17,594,117
17
1,386,905
( 9 )
( 1,416,827 )
( 29,914 )
Net income
—
—
—
—
12,421
12,421
Net change in unrealized gain on short-term investments
—
—
—
20
—
20
Issuance of common stock upon exercise of options
16,363
—
158
—
—
158
Issuance of common stock upon vesting of RSUs
2,500
—
—
—
—
—
Stock-based compensation expense
—
2,679
—
—
2,679
Balance as of September 30, 2024
17,612,980
$
17
$
1,389,742
$
11
$
( 1,404,406 )
$
( 14,636 )
See Accompanying Notes to Condensed Financial Statements
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RIGEL PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOW S
(In thousands)
(unaudited)
Nine Months Ended September 30,
2025
2024
Operating activities
Net income
$
98,959
$
3,144
Adjustments to reconcile net income to net cash provided by operating activities:
Stock-based compensation expense
9,963
10,306
Gain on sale and disposal of fixed assets
—
( 23 )
Depreciation and amortization
1,814
1,624
Release of cost share liability
( 39,981 )
—
Net amortization of discount on short-term investments and term loans
( 907 )
( 433 )
Changes in assets and liabilities:
Accounts receivable, net
( 4,310 )
( 25 )
Inventories
( 6,766 )
( 1,161 )
Prepaid and other current and non-current assets
( 8,461 )
( 3,484 )
Right-of-use assets
( 804 )
456
Accounts payable
507
( 3,327 )
Accrued compensation
( 74 )
( 752 )
Accrued research and development
743
80
Revenue reserves and refund liability
3,580
6,508
Other accrued liabilities
( 1,453 )
4,566
Lease liabilities
865
( 511 )
Net cash provided by operating activities
53,675
16,968
Investing activities
Maturities of short-term investments
47,580
32,950
Purchases of short-term investments
( 114,571 )
( 17,562 )
Capital expenditures
( 12 )
( 10 )
Payments for acquisition of intangible assets
—
( 360 )
Proceeds from sale of property and equipment
—
26
Net cash (used in) provided by investing activities
( 67,003 )
15,044
Financing activities
Net proceeds from issuance of common stock from equity plans
5,173
499
Closing purchase price payment related to asset acquisition
—
( 10,000 )
Cost share payments to a collaboration partner
—
( 3,605 )
Net cash provided by (used in) financing activities
5,173
( 13,106 )
Net (decrease) increase in cash, cash equivalents and restricted cash
( 8,155 )
18,906
Cash and cash equivalents at beginning of period
56,746
32,786
Cash, cash equivalents, and restricted cash at end of period
$
48,591
$
51,692
Supplemental disclosure of cash flow information
Interest paid
$
5,009
$
5,292
Increase in right-of-use assets and lease liabilities
$
1,220
$
—
Acquisition-related liabilities
$
5,000
$
5,000
See Accompanying Notes to Condensed Financial Statements
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Rigel Pharmaceuticals, In c.
Notes to Condensed Financial Statements
(unaudited)
In this report, “Rigel,” “we,” “us” and “our” refer to Rigel Pharmaceuticals, Inc.
1.
Organization and Summary of Significant Accounting Policies
Description of Business
We are a biotechnology company dedicated to developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. We focus on products that address signaling pathways that are critical to disease mechanisms.
TAVALISSE ® (fostamatinib disodium hexahydrate) is our first product approved by the US Food and Drug Administration (FDA). TAVALISSE is the only approved oral spleen tyrosine kinase (SYK) inhibitor for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The product is also commercially available in Europe and the United Kingdom (UK) (as TAVLESSE), and in Canada, Israel, Japan and the Republic of Korea (Korea) (as TAVALISSE) for the treatment of chronic ITP in adult patients.
REZLIDHIA ® (olutasidenib) is o ur second FDA-approved product. REZLIDHIA capsules are indicated for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. W e in-licensed REZLIDHIA from Forma Therapeutics, Inc., now Novo Nordisk (Forma), with exclusive, worldwide rights for its development, manufacturing and commercialization.
GAVRETO ® (pralsetinib) is our third FDA-approved product which we began commercializing in June 2024. GAVRETO is a once daily, small molecule, oral, kinase inhibitor of wild-type rearranged during transfection (RET) and oncogenic RET fusions. GAVRETO is approved by the FDA for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. GAVRETO is also approved under accelerated approval based on overall response rate and duration response rate, for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). We acquired the rights to research, develop, manufacture and commercialize GAVRETO in the US from Blueprint Medicines Corporation, now a Sanofi SA company (Blueprint), pursuant to an Asset Purchase Agreement entered in February 2024.
We continue to advance the development of R289, our dual interleukin receptor-associated kinases 1 and 4 (IRAK1/4) inhibitor program, in an open-label, Phase 1b study to determine the safety, tolerability and preliminary efficacy of the drug in patients with lower-risk myelodysplastic syndrome (MDS) who are relapsed, refractory or resistant to prior therapies.
We have strategic development collaborations with The University of Texas MD Anderson Cancer Center (MDACC) to expand our evaluation of olutasidenib in AML and other hematologic cancers with IDH1 mutations, and with Collaborative Network for Neuro-Oncology Clinical Trials (CONNECT) to conduct a Phase 2 clinical trial to evaluate olutasidenib in combination with temozolomide in patients with high-grade glioma (HGG) harboring an IDH1 mutation. We also have a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor program in clinical development with our partner Eli Lilly and Company (Lilly).
Basis of Presentation
Our accompanying unaudited condensed financial statements have been prepared in accordance with United States generally accepted accounting principles (US GAAP), for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities Act of 1933, as amended (Securities Act). Accordingly, they do not include all the information and notes required by US GAAP for complete financial statements.
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These unaudited condensed financial statements include only normal and recurring adjustments that we believe are necessary to fairly state our financial position and the results of our operations and cash flows. Interim-period results are not necessarily indicative of results of operations or cash flows for a full-year or any subsequent interim period. The balance sheet as of December 31, 2024 has been derived from audited financial statements at that date but does not include all disclosures required by US GAAP for complete financial statements. Because certain disclosures required by US GAAP for complete financial statements are not included herein, these interim unaudited condensed financial statements and the notes accompanying them should be read in conjunction with our audited financial statements and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2024.
Use of Estimates
The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Actual results could differ from these estimates.
Significant Accounting Policies
Our significant accounting policies are described in “Note 1 – Description of Business and Summary of Significant Accounting Policies” to our “Notes to Financial Statements” contained in Part II, Item 8, “Financial Statements and Supplementary Data” of our Annual Report on Form 10-K for the year ended December 31, 2024.
Liquidity
As of September 30, 2025, we had approximately $ 137.1 million in cash, cash equivalents and short-term investments. We finance our operations primarily through sales of our products, and contract payments under our collaboration agreements, as well as through equity securities and debt financing.
Based on our current operating plan, we believe that our existing cash, cash equivalents, and short-term investments will be sufficient to fund our expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of this Form 10-Q.
Recently Issued Accounting Standards
In December 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-09, Improvements to Income Tax Disclosures , which enhance the annual disclosure requirements regarding the tax rate reconciliation and income taxes paid information. This update is effective for our fiscal year ending December 31, 2025, and maybe adopted on a prospective or retrospective basis. Early adoption is permitted. We are currently evaluating the impact that the adoption of this guidance may have on our annual income tax disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures. This new guidance improves the disclosures about a public business entity’s expenses by requiring more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation and amortization) included within income statement expense captions. This guidance is effective for our annual reporting for the fiscal year ending December 31, 2027, and interim reporting periods beginning for the fiscal year ending December 31, 2028, early adoption is permitted. Upon adoption, this guidance may be applied prospectively to reporting periods after the effective date or retrospectively to all periods presented in the financial statements. We are currently evaluating this guidance and assessing the potential impact on our financial statements and disclosures.
In July 2025, FASB issued ASU 2025-05, Measurement of Credit Losses for Accounts Receivable and Contract Assets , which provides a practical expedient to measure credit losses on accounts receivable and contract assets. The ASU is effective for annual periods beginning after December 15, 2025, and interim periods within those annual reporting periods. Early adoption is permitted. We are currently evaluating the timing of the adoption and the impact of this guidance but do not expect it to have a significant impact to our financial statements and disclosures.
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Other recently issued accounting guidance not discussed in this Quarterly Report on Form 10-Q are either not applicable or did not have, or are not expected to have, a material impact on us.
2.
Net Income Per Share
The following table sets forth the computation of basic and diluted earnings per share (in thousands except per share amounts):
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
EPS Numerator:
Net income
$
27,900
$
12,421
$
98,959
$
3,144
EPS Denominator—Basic:
Weighted-average common shares outstanding
18,038
17,600
17,912
17,556
EPS Denominator—Diluted:
Weighted-average common shares outstanding
18,038
17,600
17,912
17,556
Dilutive effect of stock options, RSUs and shares under Purchase Plan
1,118
48
467
43
Weighted-average shares outstanding and common stock equivalents
19,156
17,648
18,379
17,599
Net income per share
Basic
$
1.55
$
0.71
$
5.52
$
0.18
Diluted
$
1.46
$
0.70
$
5.38
$
0.18
The potential shares of common stock that were excluded from the computation of diluted net income per share for the periods presented because including them would have been antidilutive are as follows (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Stock options
1,166
3,667
2,223
3,668
RSUs
—
107
174
110
Shares under Purchase Plan
—
22
—
22
Total
1,166
3,796
2,397
3,800
3.
Revenues
Revenues disaggregated by category were as follows (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Product sales:
Gross product sales
$
85,624
$
56,322
$
225,508
$
143,728
Discounts and allowances
( 21,557 )
( 17,395 )
( 58,943 )
( 45,348 )
Total product sales, net
64,067
38,927
166,565
98,380
Revenues from collaborations:
Release of cost share liability
—
—
39,981
—
License revenue
—
10,000
—
10,000
Milestone revenue
—
—
3,000
—
Delivery of drug supplies, royalty and others
5,395
6,380
14,934
13,302
Total revenues from collaborations
5,395
16,380
57,915
23,302
Total revenues
$
69,462
$
55,307
$
224,480
$
121,682
Revenue from product sales is related to sales of our commercial products to our customers. For detailed discussions of our revenues from collaborations, see “Note 4 – Sponsored Research and License Agreements.”
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Our net product sales include gross product sales, net of chargebacks, discounts and fees, government and other rebates and returns. Of the total discounts and allowances from gross product sales for the nine months ended September 30, 2025 and 2024, $ 53.6 million and $ 44.6 million, respectively, was accounted for as additions to revenue reserves and refund liability, and $ 5.3 million and $ 0.7 million, respectively, as reductions in accounts receivable (as it relates to allowance for prompt pay discount) and prepaid and other current assets (as it relates to certain chargebacks and other fees that were prepaid) in the condensed balance sheet.
The following tables summarize the activities in chargebacks, discounts and fees, government and other rebates and returns that were accounted for within revenue reserves and refund liability, for each of the periods presented (in thousands):
Chargebacks,
Government
Discounts and
and Other
Fees
Rebates
Returns
Total
Balance as of January 1, 2025
$
13,374
$
8,343
$
4,723
$
26,440
Provision related to current period sales
40,399
14,261
1,921
56,581
Adjustment related to prior period sales
( 307 )
( 1,287 )
( 1,357 )
( 2,951 )
Credit or payments made during the period
( 40,673 )
( 8,950 )
( 427 )
( 50,050 )
Balance as of September 30, 2025
$
12,793
$
12,367
$
4,860
$
30,020
Chargebacks,
Government
Discounts and
and Other
Fees
Rebates
Returns
Total
Balance as of January 1, 2024
$
8,236
$
3,517
$
3,931
$
15,684
Provision related to current period sales
34,565
9,167
884
44,616
Credit or payments made during the period
( 31,363 )
( 6,441 )
( 304 )
( 38,108 )
Balance as of September 30, 2024
$
11,438
$
6,243
$
4,511
$
22,192
Adjustment related to prior period sales reflect updates to estimates of variable consideration, including chargebacks, rebates, and returns, resulting from actual claims and other information obtained in the current reporting period.
The following table summarizes the percentages of revenues from each of our customers who individually accounted for 10% or more of the total net product sales and revenues from collaborations:
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
McKesson Corporation
48 %
43 %
39 %
44 %
Cencora, Inc.
23 %
19 %
17 %
20 %
Optime Care, Inc.
11 %
*
*
*
Cardinal Health, Inc.
10 %
*
*
15 %
Lilly
—
—
18 %
—
Kissei
*
23 %
*
14 %
* Denotes less than 10%
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4.
Sponsored Research and License Agreements
Sponsored Research and License Agreements
We conduct research and development programs independently and in connection with our corporate collaborators. We are a party to collaboration agreements with Lilly to develop and commercialize ocadusertib (previously R552), a RIPK1 inhibitor; with Grifols S.A. (Grifols) to commercialize fostamatinib for human diseases in all indications in Grifols territory which includes Europe, the UK, Turkey, the Middle East, North Africa and Russia (including Commonwealth of Independent States (CIS)); with Kissei Pharmaceutical Co., Ltd. (Kissei) to develop and commercialize fostamatinib in Japan, China, Taiwan and Korea, and olutasidenib in Japan, Korea and Taiwan; with Medison Pharma Trading AG (Medison Canada) and Medison Pharma Ltd. (Medison Israel and, together with Medison Canada, Medison) to commercialize fostamatinib in all indications, in Medison territory which includes Canada and Israel; with Knight Therapeutics International SA (Knight) to commercialize fostamatinib in all indications, in Knight territory which includes Latin America, consisting of Mexico, Central and South America, and the Caribbean; and with Dr. Reddy’s Laboratories (Dr. Reddy’s) to commercialize olutasidenib in Dr. Reddy’s territory which includes Latin America, South Africa, India, Australia, New Zealand, and certain countries in the CIS, Southeast Asia region and North Africa.
Further, we are also a party to collaboration agreements, but do not have ongoing performance obligations with BerGenBio ASA, now Oncoinvent ASA (BerGenBio) for the development and commercialization of AXL receptor tyrosine kinase i nhibitor, R428 (now referred to as bemcentinib (BGB324)), and with Daiichi Sankyo (Daiichi) to pursue research related to murine double minute 2 ( MDM2) inhibitor, DS-3032 (now referred as milademetan).
Under the above existing agreements that we entered into in the ordinary course of business, we received or may be entitled to receive upfront cash payments, payments contingent upon specified events achieved by such partners and royalties on any net sales of products sold by such partners under the agreements. The total potential future contingent payments due to us under all existing collaboration agreements are approximately $ 1.1 billion, which amount reflects the impact of Lilly’s notice of intent to terminate the central nervous system (CNS) disease program in October 2025, as discussed in more detail below, and assumes that all potential product candidates achieve every payment-triggering milestone under our current agreements. Of this amount, $ 179.5 million relates to the achievement of development events, $ 270.6 million relates to the achievement of regulatory events and $ 637.0 million relates to the achievement of certain commercial events. This estimated future contingent amount does not include any estimated royalties that could be due to us if the partners successfully commercialize any of the licensed products. Future events that may trigger payments to us under the agreements are based solely on our partners’ future efforts and achievements of specified development, regulatory and/or commercial events.
We account for the milestone payments when such milestones are considered probable of being achieved, and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our or the licensee’s control, such as regulatory approvals, are not considered probable of being achieved until uncertainty associated with the approvals has been resolved. The transaction price is then allocated to each performance obligation, on a relative standalone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, we re-evaluate the probability of achieving such milestones and any related constraint, and if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, and recorded as part of contract revenues from collaborations during the period of adjustment.
Global Exclusive License Agreement with Lilly
We have a global exclusive license agreement and strategic collaboration with Lilly entered in February 2021, which became effective in March 2021 upon clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and was amended in September 2023 (first amendment), March 2024 (second amendment), and in August 2025 (third amendment) (collectively, Lilly Agreement). The collaboration is to develop and commercialize ocadusertib (previously R552) for the treatment of non-central nervous system (non-CNS) diseases, and additional RIPK1 inhibitors for the treatment of CNS diseases. Pursuant to the terms of the Lilly Agreement, we granted Lilly the exclusive rights to develop and commercialize ocadusertib and related RIPK1 inhibitors in all indications worldwide. The parties’
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collaboration is governed through a joint governance committee and appropriate subcommittees.
Under the terms of the Lilly Agreement, we were entitled to receive a non-refundable and non-creditable upfront cash payment amounting to $ 125.0 million, which we received in April 2021. We are also entitled to additional milestone payments for non-CNS disease products consisting of up to $ 330.0 million in milestone payments upon the achievement of specified development, regulatory and commercial milestones, and up to $ 100.0 million in sales milestone payments on a product-by-product basis. In addition, depending on the extent of our co-funding of ocadusertib development activities, we would be entitled to receive tiered royalty payments on net sales of non-CNS disease products at percentages ranging from the mid-single digits to high-teens, subject to certain standard reductions and offsets. Under the terms of the Lilly Agreement, we were also eligible to receive milestone payments for CNS disease products consisting of up to $ 256.0 million in milestone payments upon the achievement of specified development, regulatory and commercial milestones, up to $ 150.0 million in sales milestone payments on a product-by-product basis, and tiered royalty payments on net sales of CNS disease products up to low-double digits, subject to certain standard reductions and offsets. On October 1, 2025, we received a notice from Lilly of its intent to terminate the CNS disease program under the Lilly Agreement, which will become effective sixty ( 60 ) days following notification. Following the termination of the CNS disease program, we do not believe we will be entitled to receive any future milestone and royalty payments associated with this program.
Under the Lilly Agreement, we were responsible for performing and funding initial discovery and identification of CNS disease development candidates. Following candidate selection, Lilly is responsible for performing and funding all future development and commercialization of the CNS disease development candidates. Under the Lilly Agreement, we are responsible for 20 % of the development costs for ocadusertib in the US, Europe, and Japan, up to a specified cap, and Lilly is responsible for funding the remainder of all development activities for ocadusertib and other non-CNS disease development candidates. Pursuant to the terms of the Lilly Agreement, we have the right to opt-out of co-funding the ocadusertib development activities in the US, Europe and Japan at two different specified times and as a result receive lesser royalties from sales. Under the Lilly Agreement, the first opt-out right was exercised prior to September 30, 2023, and we were therefore required to fund our share of the ocadusertib development activities up to a maximum funding commitment of $ 65.0 million through April 1, 2024.
We accounted for this agreement under ASC 606. At the inception of the Lilly Agreement, given our rights to opt-out from the development of ocadusertib, we believed at the minimum, we had a commitment to fund the development costs up to $ 65.0 million as discussed above. We considered this commitment to fund the development costs as a significant financing component of the contract, which we accounted for as a reduction of the upfront fee to derive the transaction price. This financing component was recorded as a liability at its net present value of approximately $ 57.9 million using a 6.4 % discount rate and interest was accreted on such liability over the expected commitment period, adjusted for timing of expected cost share payments. We allocated the net transaction price of $ 67.1 million to each performance obligation based on our best estimate of its relative standalone selling price using the adjusted market assessment approach. The transaction price allocated to the non-CNS penetrant IP of $ 60.4 million was recognized as revenue upon delivery of the non-CNS penetrant IP to Lilly during the first quarter of 2021. The transaction price allocated to the CNS penetrant IP of $ 6.7 million was recognized as revenue from the effective date of the Lilly Agreement through the eventual acceptance by Lilly in June 2022 using the input method. There was no outstanding deferred revenue related to Lilly Agreement as of September 30, 2025 and December 31, 2024.
In September 2023, we provided our first-opt out notice to Lilly, and concurrently entered into an amendment to the Lilly Agreement. The amended Lilly Agreement provided, among others that if we exercise our first opt-out right, we have the right to opt-in to the co-funding of ocadusertib development, upon us providing notice to Lilly within 30 days of certain events as specified in the Lilly Agreement, and as a result receive greater royalties from sales. If we exercised our opt-in right, we would be required to continue to share in global development costs, capped at a specified amount and for a specified period if the second opt-out right was exercised.
As discussed above, following us providing the first opt-out notice to Lilly, our cost share obligation for ocadusertib development ended on April 1, 2024. We paid Lilly a total of $ 21.4 million for our share of development costs incurred through April 1, 2024. As of December 31, 2024, the outstanding liability to Lilly reported within other long-term liabilities in the condensed balance sheets amounted to $ 40.0 million. Although our cost share obligation for the ocadusertib development ended on April 1, 2024, the remaining cost share liability was not released in the periods
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prior to us providing the notice to Lilly not to exercise our opt-in right because we were not able to conclude that it was probable that a significant reversal of the amount of revenue, if recognized, would not occur until the likelihood of us exercising our opt-in right became remote, or when the opt-in right period lapsed.
On April 30, 2025, we provided notice to Lilly of our decision not to exercise our opt-in right following our evaluation of certain events specified in the Lilly Agreement. Following this notification, we are no longer obligated to share in any future global development costs. As such, we released the $ 40.0 million remaining cost share liability and recognized the amount as contract revenues from collaboration in the second quarter of 2025.
Grifols License Agreement
We have an exclusive commercialization license agreement with Grifols entered in January 2019 with exclusive rights to commercialize fostamatinib for human diseases, and non-exclusive rights to develop fostamatinib in Grifols territory. Under the agreement, we received an upfront payment of $ 30.0 million, with the potential for $ 297.5 million in total regulatory and commercial milestones. We are also entitled to receive stepped double-digit royalty payments based on tiered net sales which may reach 30 % of net sales. In January 2020, the European Commission (EC) granted a centralized Marketing Authorization (MA) for fostamatinib valid throughout the European Union (EU) and in the UK after the departure of the UK from the EU for the treatment of chronic ITP in adult patients who are refractory to other treatments. With this approval, in February 2020, we received $ 20.0 million non-refundable payment, composed of a $ 17.5 million payment due upon Marketing Authorization Application (MAA) approval by the European Medicines Agency (EMA) of fostamatinib for the first indication and a $ 2.5 million creditable advance royalty payment, based on the terms of our collaboration agreement with Grifols. We accounted for this agreement under ASC 606, and recognized the corresponding revenue in the period we satisfied the performance obligations. There was no outstanding deferred revenue related to the Grifols license agreement as of September 30, 2025 and December 31, 2024.
We have a commercial supply agreement with Grifols entered in October 2020 to supply and sell our drug product priced at a certain markup specified in the agreement, in quantities Grifols orders from us pursuant to and in accordance with the agreement. Revenue recognized related to the delivery of drug supply to Grifols for the three months ended September 30, 2025 and 2024 was $ 1.2 million and $ 2.0 million, respectively, and for the nine months ended September 30, 2025 and 2024 was $ 4.9 million and $ 2.0 million, respectively.
We recognize royalty revenue from Grifols included within contract revenues from collaboration. Royalty revenue recognized for the three months ended September 30, 2025 and 2024 was $ 1.9 million and $ 1.3 million, respectively, and for the nine months ended September 30, 2025 and 2024 was $ 5.0 million and $ 3.5 million, respectively.
Kissei License Agreements
We have a collaboration and license agreement with Kissei entered in September 2024 to grant exclusive rights to Kissei to develop and commercialize olutasidenib in all human diseases in Japan, Korea and Taiwan. Kissei is responsible for performing and funding the development activities for olutasidenib in the Kissei territory and we retained the co-exclusive right to conduct development activities in the Kissei territory solely for the purpose of supporting and obtaining regulatory approval of and commercializing olutasidenib in the world outside the Kissei territory. Under the terms of the agreement, we received a one-time, non-refundable, and non-creditable upfront cash payment of $ 10.0 million, with the potential for up to an additional $ 152.5 million in development, regulatory and commercial milestone payments, and will receive mid twenty to lower thirty percent, tiered, escalated net sales-based payments for the supply of olutasidenib, subject to certain standard reductions and offsets . Pursuant to the agreement, Kissei is responsible for companion diagnostic development in Japan, for which we will share 50 % of the costs incurred by Kissei, up to $ 3.0 million, which are creditable against future milestones and transfer price payments owed to us . We remain responsible for the manufacture and supply of olutasidenib for all development and commercialization activities under the agreement. Pursuant to the concurrently executed supply agreement, we will supply Kissei with bulk drug product for use under the collaboration and license agreement. We accounted for this agreement following ASC 606 and concluded at the inception of the agreement, the upfront cash payment of $ 10.0 million was the consideration for granting the license right to Kissei, and there are no other material deliverables associated with the upfront payment. Accordingly, we recognized the upfront payment as revenue during the third quarter of 2024.
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We also have an exclusive license and supply agreement with Kissei entered in October 2018, amended in November 2022, October 2023, August 2024, September 2024 and October 2024, to develop and commercialize fostamatinib in all current and potential indications in Japan, China, Taiwan and Korea. Kissei is responsible for performing and funding all development activities for fostamatinib in the above-mentioned territories. At the inception of the agreement, we received an upfront cash payment of $ 33.0 million. Further, the agreement provides for up to $ 115.0 million in potential development, regulatory and commercial milestone payments, and mid- to upper twenty percent, tiered, escalated net sales-based payments for the supply of fostamatinib. Under the agreement, we granted Kissei the license rights to fostamatinib in Kissei’s territory and are obligated to supply Kissei with drug product for use in clinical trials and pre-commercialization activities. We are also responsible for the manufacture and supply of fostamatinib for all future development and commercialization activities. We accounted for this agreement under ASC 606, and recognized the corresponding revenue in the period we satisfied the performance obligations. As of September 30, 2025 and December 31, 2024, the remaining deferred revenue was related to the material right associated with discounted fostamatinib supply which amounted to $ 1.4 million . No revenue was recognized during the three and nine months ended September 30, 2025 and 2024 associated with the remaining performance obligation.
In April 2022, Kissei announced that an NDA for fostamatinib in chronic ITP was submitted to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and in December 2022, Kissei announced that Japan’s PMDA approved the NDA. Following such milestones, we were entitled to receive a total of $ 25.0 million non-refundable and non-creditable milestone payments that we recognized as revenue in 2022. In January 2025, Kissei announced the Korean Ministry of Food and Drug Safety approved fostamatinib for the treatment of chronic ITP, which entitled us to receive a $ 3.0 million non-refundable and non-creditable milestone payment that we recognized as revenue in the first quarter of 2025.
Revenue recognized related to the delivery of drug supply to Kissei for the three months ended September 30, 2025 and 2024 was $ 1.8 million and $ 3.0 million, respectively, and for the nine months ended September 30, 2025 and 2024 was $ 3.9 million and $ 7.5 million, respectively.
Medison Commercial and License Agreements
We have exclusive commercial and license agreements with Medison entered in October 2019 for the commercialization of fostamatinib for chronic ITP in Medison territory, pursuant to which, we received a $ 5.0 million upfront payment with respect to the agreement in Canada. We accounted for this agreement under ASC 606, and recognized the revenue in the period we satisfied the performance obligation . There was no outstanding deferred revenue related to Medison commercial and license agreement as of September 30, 2025 and December 31, 2024.
Revenue recognized from Medison related to delivery of drug supply and earned royalties for the three months ended September 30, 2025 and 2024 was $ 0.2 million and $ 0.1 million, respectively, and for the nine months ended September 30, 2025 and 2024 was $ 0.8 million and $ 0.2 million, respectively.
Knight Commercial License and Supply Agreement
We have commercial license and supply agreements with Knight entered in May 2022 for the commercialization of fostamatinib for approved indications in Knight territory. Pursuant to such commercial license agreement, we received a $ 2.0 million one-time, non-refundable, and non-creditable upfront payment, with potential for up to an additional $ 20.0 million in regulatory and sales-based commercial milestone payments, and will receive twenty- to mid-thirty percent, tiered, escalated net-sales based royalty payments for products sold in the Knight territory. We accounted for this agreement under ASC 606, and recognized the revenue in the period we satisfied the performance obligation. There was no outstanding deferred revenue related to Knight commercial and license agreement as of September 30, 2025 and December 31, 2024. We are also responsible for the exclusive manufacture and supply of fostamatinib for all future development and commercialization activities under the agreement. No revenue was recognized during the three and nine months ended September 30, 2025 and 2024 from Knight.
Dr. Reddy’s Commercial License Agreement
We have a commercial license agreement with Dr. Reddy’s entered in November 2024, pursuant to which, we granted Dr. Reddy’s an exclusive license to develop and commercialize olutasidenib in Dr. Reddy’s territory. Pursuant to
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the commercial license agreement, we were entitled to receive a $ 4.0 million one-time, non-refundable and non-creditable upfront payment , which amount, net of applicable foreign withholding taxes was received in February 2025. In addition, we are entitled to a potential for up to an additional $ 36.0 million in regulatory and sales-based commercial milestone payments, and will receive high teens- to thirty percent, tiered, escalated net-sales based royalty payments for products sold in Dr. Reddy’s territory, subject to certain standard reductions and offsets. Dr. Reddy’s is responsible for performing and funding all development activities necessary to obtain regulatory approval and commercialize olutasidenib in the Dr. Reddy’s territory. We are responsible for the exclusive manufacture and supply of olutasidenib for all future development and commercialization activities under the agreement. We accounted for this agreement following ASC 606 and concluded at the inception of the agreement, the upfront cash payment of $ 4.0 million was the consideration for granting the license right to Dr. Reddy’s, which revenue was recognized during the fourth quarter of 2024. In August 2025, we entered into a supply agreement with Dr. Reddy’s. During the three and nine months ended September 30, 2025, we recognized $ 0.1 million of revenue related to delivery of drug supply to Dr. Reddy’s.
Strategic Development Collaborations with MDACC and CONNECT
We have a Strategic Collaboration Agreement with MDACC, a comprehensive cancer research, treatment, and prevention center, entered in December 2023. The collaboration will expand our evaluation of olutasidenib in AML and other hematologic cancers. Under the collaboration, we will provide MDACC the study materials and $ 15.0 million in time-based milestone payments as compensation for services to be provided for the studies, over the five-year collaboration term, unless terminated earlier as provided for in the agreement. Through September 30, 2025, we provided $ 5.3 million funding to MDACC.
In January 2024, we announced our collaboration with CONNECT, an international collaborative network of pediatric cancer centers, to conduct a Phase 2 clinical trial to evaluate olutasidenib in glioma. Under the collaboration, we will provide funding up to $ 3.0 million and study material over the four-year collaboration.
We account for the funding we provide under the above research collaboration agreements as prepaid research and development in the condensed balance sheet to the extent the payment is made in advance of services being rendered, and recognize such amount as research and development expense within the statements of operations as the collaborative partners render the services under the respective agreement.
5.
In-licensing and Acquisition
Asset Purchase Agreement with Blueprint
We acquired the US rights to research, develop, manufacture and commercialize GAVRETO from Blueprint pursuant to an Asset Purchase Agreement entered in February 2024. The acquired assets from Blueprint include, among other things, applicable intellectual property related to pralsetinib in the US, including patents, copyrights and trademarks, as well as clinical regulatory and commercial data and records. Pursuant to the Asset Purchase Agreement, we agreed to pay a purchase price of $ 15.0 million, of which, $ 10.0 million was payable upon our first commercial sale of GAVRETO and an additional $ 5.0 million is payable on the first anniversary of the closing date of the agreement, subject to certain conditions. Blueprint is also eligible to receive up to $ 97.5 million in future commercial milestone payments and up to $ 5.0 million in future regulatory milestone payments. The potential regulatory milestones include full regulatory approval of pralsetinib (or related compounds) for the treatment of adult RET-fusion positive thyroid cancer, and maintenance of the current regulatory approval of pralsetinib for the treatment of adult RET-fusion positive thyroid cancer during the period beginning on February 22, 2024 and ending on the third anniversary of the first commercial sale of pralsetinib subject to certain conditions. Subject to the terms and conditions of the Asset Purchase Agreement, Blueprint would be entitled to tiered royalty payments on net sales of products containing pralsetinib (or related compounds) ranging from 10 % to 30 %, subject to certain reductions and offsets.
We accounted for this transaction as an asset acquisition in accordance with ASC 805 Business Combinations (ASC 805) because substantially all of the fair value of the gross assets acquired is concentrated in a single asset, which is the GAVRETO product rights. The GAVRETO product rights comprised developed technology, customers, trademarks and trade name, and are considered a single asset as they are inextricably linked.
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The total purchase price consideration amounted to $ 15.4 million, comprised the closing purchase price of $ 15.0 million and transaction costs of $ 0.4 million. Of the total closing purchase price, $ 10.0 million was paid in July 2024. The remaining $ 5.0 million was outstanding and presented as acquisition-related liabilities in the condensed balance sheet as of September 30, 2025 and December 31, 2024. We classify the outstanding acquisition-related liabilities as current or non-current liabilities based on the period the amount is expected to be due as of the balance sheet date. In accordance with the guidance, we classify payments of the closing purchase price under financing activity in the condensed statements of cash flows, considering that the payments are not made soon after the acquisition date.
Since we acquired a single asset, the total purchase consideration was recorded as intangible assets at acquisition date. The related intangible assets are being amortized on a straight-line basis over the estimated useful life of 12 years , and the related amortization is recorded within cost of product sales. The contingent considerations relating to future commercial and regulatory milestones were not included in the total purchase price consideration, and will be accounted for when the contingency is resolved and the consideration becomes payable. Royalties are recognized within cost of product sales, as revenue from GAVRETO product sales is recognized.
License and Transition Services Agreement with Forma
We have a license and transition services agreement with Forma entered in July 2022, for an exclusive license to develop, manufacture and commercialize olutasidenib, a proprietary inhibitor of mutated IDH1 (mIDH1), for any uses worldwide, including for the treatment of AML and other malignancies. Pursuant to the terms of the license and transition services agreement, we paid an upfront fee of $ 2.0 million, with the potential to pay up to $ 67.5 million of additional payments upon achievement of specified development and regulatory milestones and up to $ 165.5 million of additional payments upon achievement of certain commercial milestones. In addition, subject to the terms and conditions of the license and transition services agreement, Forma would be entitled to tiered royalty payments on net sales of licensed products at percentages ranging from low-teens to mid-thirties, as well as certain portion of our sublicensing revenue, subject to certain standard reductions and offsets.
The transaction was accounted for as an acquisition of asset under ASC 730, Research and Development . In accordance with the guidance, in a transaction accounted for as an asset acquisition, any acquired in-process research and development (IPR&D) that does not have alternative future use is charged to expense at the acquisition date. At the acquisition date, the acquired license asset was accounted for as IPR&D, and we anticipated no other economic benefit to be derived from such acquired licensed asset other than the primary indications. As such, we accounted for the upfront fee of $ 2.0 million as IPR&D and recorded such cost within research and development expense in the statements of operations in 2022.
Under the accounting guidance, we account for contingent payments when a contingency is resolved, and the consideration becomes payable. We account for m ilestone payment obligations incurred at development stage and prior to a regulatory approval of an indication associated with the acquired licensed asset as research and development expense when the event requiring payment of the milestone occurs. Milestone payment obligations incurred upon and after a regulatory approval of an indication associated with the acquired licensed asset, and at the commercial stage, are recorded as intangible assets when the event requiring payment of the milestones occurs. Prior to the FDA approval of REZLIDHIA in December 2022, a certain regulatory milestone was met which entitled Forma to receive a $ 2.5 million milestone payment. Because such milestone payment obligation was incurred prior to a regulatory approval of an indication associated with the acquired licensed asset, we recorded such amount as research and development expense in the fourth quarter of 2022. On December 1, 2022, the FDA approved REZLIDHIA capsules for the treatment of adult patients with R/R AML with susceptible IDH1 mutations as detected by an FDA-approved test. Following the FDA approval, we launched REZLIDHIA and made first shipments of the product to our customers in December 2022. With this FDA approval and first commercial sale of the product, Forma was entitled to receive a total of $ 15.0 million milestone payments. Since such milestone payment obligations were incurred upon and after regulatory approval of the product, we recorded such amount as intangible assets on our condensed balance sheet in the fourth quarter of 2022.
The amount recorded as intangible asset is being amortized on a straight-line basis over the estimated useful life of 14 years , and the related amortization is recorded within cost of product sales . Royalties are recognized within cost of product sales, as revenue from REZLIDHIA product sales is recognized.
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6.
Stock-Based Compensation
Stock-based compensation for the periods presented was as follows (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Selling, general and administrative
$
2,961
$
2,360
$
8,172
$
9,067
Research and development
402
284
1,791
1,239
Total stock-based compensation expense
$
3,363
$
2,644
$
9,963
$
10,306
During the nine months ended September 30, 2025, we granted stock options to purchase 633,417 shares of common stock with weighted-average grant-date fair value of $ 16.89 per share, and the grants generally vest over 3 years . During the nine months ended September 30, 2025, 347,016 stock options were exercised. As of September 30, 2025, there were 3,640,274 stock options outstanding, of which, 168,564 are outstanding performance-based stock options wherein the achievement of the corresponding corporate-based milestones were assessed not probable as of September 30, 2025. Accordingly, none of the $ 3.2 million grant date fair value for these awards has been recognized as stock-based compensation expense as of September 30, 2025.
The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model. The following table summarizes the weighted-average assumptions relating to options granted pursuant to our 2018 Equity Incentive Plan (2018 Plan) and our Inducement Plan, as amended (Inducement Plan, and together with 2018 Plan, the Equity Incentive Plans) for the periods presented:
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Risk-free interest rate
3.9
%
3.8
%
4.3
%
4.1
%
Expected term (in years)
6.0
6.0
6.5
6.1
Dividend yield
0.0
%
0.0
%
0.0
%
0.0
%
Expected volatility
91.0
%
88.7
%
88.6
%
87.6
%
During the nine months ended September 30, 2025, we granted 350,047 RSUs with a grant-date weighted-average fair value of $ 19.27 per share, and the grants generally vest over 3 years . During the nine months ended September 30, 2025, 143,691 RSUs were released. As of September 30, 2025, there were 569,106 RSUs outstanding.
As of September 30, 2025, there was approximately $ 17.3 million of unrecognized stock-based compensation cost which is expected to be recognized over a remaining weighted-average period of 2.04 years, related to time-based stock options, performance-based stock options wherein achievement of the corresponding corporate-based milestones was considered as probable, and RSUs.
During the nine months ended September 30, 2025, our Board of Directors approved an additional 42,925 shares of common stock reserved for issuance under our Inducement Plan. In May 2025, our stockholders approved an amendment to our 2018 Plan to, among other items, add an additional 700,000 shares to the number of shares of common stock authorized for issuance under our 2018 Plan. As of September 30, 2025, there were 1,407,956 shares of common stock available for future grant under our Equity Incentive Plans.
Employee Stock Purchase Plan
Our Purchase Plan provides for a 24 -month offering period comprises four six-month purchase periods with a look-back option. A look-back option is a provision in our Purchase Plan under which eligible employees can purchase shares of our common stock at a price per share equal to the lesser of 85 % of the fair market value on the first day of the offering period or 85 % of the fair market value on the purchase date. Our Purchase Plan also includes a feature that provides for a new offering period to begin when the fair market value of our common stock on any purchase date during an offering period falls below the fair market value of our common stock on the first day of such offering period. This feature is called a “reset.” Participants are automatically enrolled in the new offering period.
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Our 24 -month offering period under our Purchase Plan ended on June 30, 2024, and a new 24 -month offering period started on July 1, 2024. The fair value of awards under our Purchase Plan is estimated on the date of our new offering period using the Black-Scholes option pricing model, which is being amortized over the requisite service periods. As of September 30, 2025, there was approximately $ 0.2 million of unrecognized stock-based compensation cost which is expected to be recognized over a remaining weighted-average period of 0.59 years, related to our Purchase Plan.
During the nine months ended September 30, 2025, there were 39,801 shares purchased under the Purchase Plan. As of September 30, 2025, there were 144,373 shares reserved for future issuance under the Purchase Plan.
7.
Other Balance Sheet Components
Inventories
Inventories for the periods presented consist of the following (in thousands):
As of
September 30, 2025
December 31, 2024
Raw materials
$
6,950
$
1,077
Work in process
5,487
1,226
Finished goods
1,786
5,014
Total
$
14,223
$
7,317
Reported as:
Inventories
$
13,303
$
6,002
Other assets
920
1,315
Total
$
14,223
$
7,317
Non-current i nventories included within other assets in the condensed balance sheet consist of active pharmaceutical ingredient (API) classified as raw materials which have multi-year shelf life, as well as certain work in process and finished goods inventories that are not expected to be consumed beyond our normal operating cycle.
Advance payments to our contract manufacturers to manufacture APIs as well as APIs pending final release for commercial usage are classified as prepaid inventory and included within prepaid and other current assets in the condensed balance sheet . See prepaid and other current assets below for related details.
Prepaid and other current assets
Prepaid and other current assets for the periods presented consist of the following (in thousands):
As of
September 30, 2025
December 31, 2024
Prepaid inventory
$
7,308
$
3,757
Prepaid research and development costs
5,385
1,885
Others
5,863
4,523
Total prepaid and other current assets
$
18,556
$
10,165
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Intangible assets
Intangible assets consist of the following (in thousands):
As of
September 30, 2025
December 31, 2024
Intangible assets cost
$
30,360
$
30,360
Accumulated amortization
( 5,024 )
( 3,260 )
Intangible assets, net
$
25,336
$
27,100
Amortization expense recorded within cost of product sales in the condensed statements of operations for the three months ended September 30, 2025 and 2024 was $ 0.6 million and $ 0.6 million, respectively, and for the nine months ended September 30, 2025 and 2024 was $ 1.8 million and $ 1.6 million, respectively.
The following table presents the estimated future amortization expense of intangible assets as of September 30, 2025 (in thousands):
Remainder of 2025
$
587
2026
2,351
2027
2,351
2028
2,351
2029
2,351
Thereafter
15,345
$
25,336
8. Cash, Cash Equivalents, Restricted Cash, and Short-Term Investments
Cash, cash equivalents, restricted cash, and short-term investments for the periods presented consist of the following (in thousands):
As of
September 30, 2025
December 31, 2024
Cash
$
11,109
$
20,135
Restricted cash
57
—
Money market funds
16,989
16,386
US treasury bills
41,666
7,263
Government-sponsored enterprise securities
18,651
23,177
Corporate bonds and commercial paper
48,728
10,360
$
137,200
$
77,321
Reported as:
Cash and cash equivalents
$
48,534
$
56,746
Short-term investments
88,609
20,575
Restricted cash reported within other assets
57
—
$
137,200
$
77,321
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Cash equivalents and short-term investments include the following securities with gross unrealized gains and losses (in thousands):
Gross
Gross
Amortized
Unrealized
Unrealized
As of September 30, 2025
Cost
Gains
Losses
Fair Value
US treasury bills
$
41,607
$
61
$
( 2 )
$
41,666
Government-sponsored enterprise securities
18,626
26
( 1 )
18,651
Corporate bonds and commercial paper
48,716
20
( 8 )
48,728
Total
$
108,949
$
107
$
( 11 )
$
109,045
Gross
Gross
Amortized
Unrealized
Unrealized
As of December 31, 2024
Cost
Gains
Losses
Fair Value
US treasury bills
$
7,260
$
3
$
—
$
7,263
Government-sponsored enterprise securities
23,174
3
—
23,177
Corporate bonds and commercial paper
10,356
4
—
10,360
Total
$
40,790
$
10
$
—
$
40,800
As of September 30, 2025 and December 31, 2024, our cash equivalents and short-term investments had a weighted-average time to maturity of approximately 259 days and 69 days , respectively. Our short-term investments are classified as available-for-sale securities. Accordingly, we have classified these securities as short-term investments on our condensed balance sheets as they are available for use in the current operations. As of September 30, 2025, a total of 26 individual securities had been in an unrealized loss position for 12 months or less, and the losses were determined to be temporary. We regularly review the securities in an unrealized loss position and evaluate the current expected credit loss by considering factors such as historical experience, market data, issuer-specific factors, and current economic conditions. We have no t recognized any credit losses as of September 30, 2025 and December 31, 2024.
The following table shows the fair value and gross unrealized losses of our investments in individual securities that are in an unrealized loss position, aggregated by investment category (in thousands):
As of September 30, 2025
Fair Value
Gross Unrealized Losses
US treasury bills
$
5,530
$
( 2 )
Government-sponsored enterprise securities
4,228
( 1 )
Corporate bonds and commercial paper
26,655
( 8 )
Total
$
36,413
$
( 11 )
9.
Fair Value
The table below summarizes the fair value of our cash equivalents and short-term investments measured at fair value on a recurring basis, and are categorized based upon the lowest level of significant input to the valuations (in thousands):
Assets at Fair Value as of September 30, 2025
Level 1
Level 2
Level 3
Total
Money market funds
$
16,989
$
—
$
—
$
16,989
US treasury bills
—
41,666
—
41,666
Government-sponsored enterprise securities
—
18,651
—
18,651
Corporate bonds and commercial paper
—
48,728
—
48,728
Total
$
16,989
$
109,045
$
—
$
126,034
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Assets at Fair Value as of December 31, 2024
Level 1
Level 2
Level 3
Total
Money market funds
$
16,386
$
—
$
—
$
16,386
US treasury bills
—
7,263
—
7,263
Government-sponsored enterprise securities
—
23,177
—
23,177
Corporate bonds and commercial paper
—
10,360
—
10,360
Total
$
16,386
$
40,800
$
—
$
57,186
10. Debt
The following table summarizes loans payable, net (in thousands):
As of
September 30, 2025
December 31, 2024
Principal outstanding
$
60,000
$
60,000
Unamortized debt issuance costs
( 270 )
( 320 )
Principal outstanding, net of unamortized debt issuance costs
$
59,730
$
59,680
Reported as:
Loans payable, net, current portion
$
29,761
$
7,272
Long-term portion of loans payable, net
29,969
52,408
$
59,730
$
59,680
The outstanding loans payable as of the periods presented was related to our Credit and Security Agreement (Credit Agreement) with MidCap Financial Trust (MidCap) entered into on September 27, 2019 (Closing Date) and amended on March 29, 2021 (First Amendment), February 11, 2022 (Second Amendment), July 27, 2022 (Third Amendment), and on April 11, 2024 (Fourth Amendment). The Credit Agreement provides for a $ 60.0 million term loan credit facility, which was fully funded as of September 30, 2025 and December 31, 2024.
Under the Credit Agreement, as amended, the term loans mature on September 1, 2027, and the interest-only period is through October 1, 2025. The term loans bear interest equal to the sum of one-month Secured Overnight Financing Rate (SOFR) plus an adjustment of 0.11448% , subject to a 4.00 % applicable floor, plus applicable margin of 6.50 % . A final payment fee of 4.25 % of principal is due at maturity date.
We may make voluntary prepayments, in whole or in part, subject to certain prepayment premiums and additional interest payments. The Credit Agreement also contains certain provisions, such as event of default and change in control provisions, which, if triggered, would require us to make mandatory prepayments on the term loan, which are subject to certain prepayment premiums and additional interest payments. The obligations under the amended Credit Agreement are secured by a perfected security interest in all of our assets including our intellectual property.
Interest expense, including amortization of the debt discount and accretion of the final fees related to the Credit Agreement for the three months ended September 30, 2025 and 2024 was $ 1.9 million and $ 2.1 million, respectively, and for the nine months ended September 30, 2025 and 2024 was $ 5.6 million and $ 6.0 million, respectively. Accrued interest of $ 2.6 million was included within other accrued liabilities in the condensed balance sheet as of September 30, 2025.
The following table presents the future minimum principal payments of the outstanding loan as of September 30, 2025 (in thousands):
Remainder of 2025
$
7,500
2026
30,000
2027
22,500
Principal amount (Tranches 1, 2, 3 and 4)
$
60,000
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The amended Credit Agreement contains certain covenants which, among others, require us to deliver financial reports at designated times of the year and maintain minimum unrestricted cash and trailing net revenues. As of September 30, 2025, we were not in violation of any covenants.
11. Commitments and Contingencies
Operating Leases
Our current headquarters located in South San Francisco, California was previously subleased from Atara Biotherapeutics, Inc. (Atara) pursuant to a sublease agreement entered in October 2022, which lease term commenced in November 2022 and expired in May 2025. In February 2025, we entered into a lease agreement with 611 Gateway Center LP (611 Gateway) to lease the same office space, which lease term commenced following the expiration of the sublease with Atara and will expire in July 2027. Following our lease agreement with 611 Gateway, i n accordance with ASC 842, Leases , at lease measurement date, we recognized operating lease right-of-use asset and lease liabilities of approximately $ 1.2 million, which amount represents the present value of the future minimum lease payments over the term of the lease measured using our incremental borrowing rate.
The components of our operating lease expense were as follows (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Fixed operating lease expense
$
160
$
166
$
475
$
498
Variable operating lease expense
14
28
49
84
Total operating lease expense
$
174
$
194
$
524
$
582
Cash payments included in the measurement of operating lease liabilities for the three months ended September 30, 2025 and 2024 was $ 0.1 million and $ 0.2 million, respectively, and for the nine months ended September 30, 2025 and 2024 was $ 0.4 million and $ 0.6 million, respectively.
The weighted average remaining term of our leases as of September 30, 2025 was 1.83 years. The following table presents the future lease payments as of September 30, 2025 (in thousands):
Remainder of 2025
$
170
2026
692
2027
409
Total minimum payments required
$
1,271
Purchase Commitments and Obligations
In the ordinary course of business, we enter into agreements with contract manufacturers to manufacture our inventory products. Although the agreements generally provide a termination clause with or without cause, we may still be subjected to payment of cancellation fees. The level of cancellation fees is generally dependent on the timing of the written notice in relation to the commencement of work, with the maximum cancellation fees equal to the full price of the work order. In October 2024, we entered into an agreement with a third-party contract manufacturer to manufacture TAVALISSE that is expected to be delivered starting in 2026 through 2029. As of September 30, 2025, the contractual obligation not included in our financial statements related to an agreement that may potentially be subjected to cancellation fees of approximately $ 22.6 million, of which, $ 3.0 million is expected to be due in the remainder of 2025, and $ 10.5 million is expected to be due in 2026 and 2027. As of September 30, 2025, we have no t incurred any cancellation fees under our agreements with contract manufacturers.
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Legal Contingencies
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not presently a party to any material legal proceedings that, if determined adversely us, would have a material adverse effect on us.
In March 2025, we entered into a settlement agreement with Annora Pharma Private Ltd., Hetero Labs Ltd., and Hetero USA, Inc. (collectively, Annora), resolving patent litigation related to our product TAVALISSE (fostamatinib). The litigation resulted from submission by Annora of an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of TAVALISSE in the US. Under the terms of the settlement agreement, Annora will have a license to sell its generic product in the second quarter of 2032 or earlier under certain circumstances. In accordance with the settlement agreement, the parties terminated all ongoing litigation between us and Annora regarding TAVALISSE patents pending in New Jersey. For more information, see “ Part II, Item 1, Legal Proceedings” of this Quarterly Report on Form 10-Q.
12. Income Taxes
The quarterly provision for or benefit from income taxes is based on applying the estimated annual effective tax rate to the year-to-date pre-tax income, adjusted for any discrete items. We update our estimate of our annual effective tax rate at the end of each quarterly period.
The benefit from or provision for income taxes for the three and nine months ended September 30, 2025 was primarily related to estimated state income taxes. We do not expect to owe federal income tax due to sufficient net operating loss carryforwards, as well as significant research and development credit carryforwards. For the three and nine months ended September 30, 2024, we did no t record a provision for income taxes based on the forecasted pre-tax book loss.
In July 2025, the One Big Beautiful Bill Act (OBBBA), formally titled “An Act to provide for reconciliation pursuant to title II of H. Con. Res. 14.” was signed into law. The OBBBA introduces a wide range of provisions affecting business entities, including the establishment of certain permanent business tax measures. Key provisions include a permanent and immediate deduction for domestic research and development expenditures, the restoration and permanent extension of 100% expensing for qualified equipment purchases, and restores the ability to add back depreciation and amortization expense when determining the limitation on interest deductions. In accordance with ASC 740, Income Taxes , the effects of changes in tax laws are recognized in the period of enactment. Accordingly, we accounted for the estimated impact of the OBBBA in our current period tax provision. The enactment of the OBBBA did not have a material impact on our condensed financial statements for the three and nine months ended September 30, 2025.
As of September 30, 2025, we continue to record a full valuation allowance on our deferred tax assets. The realization of deferred tax assets is dependent upon demonstrating sufficient positive evidence to conclude that it is more-likely-than-not that our deferred tax assets will be realized. This assessment requires significant judgment. In making this determination, all available evidence, both positive and negative, is considered to determine whether, based on the weight of that evidence, a valuation allowance for deferred tax assets is needed. If sufficient positive evidence becomes available to allow us to reach a conclusion that a portion of the valuation allowance against the deferred tax assets may be reversed, the reversal would result in an income tax benefit for the quarterly and annual fiscal period in which we determine to release such valuation allowance.
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13. Segment Information
We view our operations and manage our business as one operating segment, and our chief operating decision maker (CODM) is our chief executive officer. The following table presents segment information for the periods presented:
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
(in thousands)
(in thousands)
Total Revenues
$
69,462
$
55,307
$
224,480
$
121,682
Less:
Employee related expenses
18,547
16,104
56,666
52,552
Commercial related expenses
6,303
6,768
18,915
19,002
Outside clinical trial related expenses
3,759
3,303
11,362
8,183
Cost of product sales
4,753
8,026
13,666
12,859
Consultants and third-party services
4,133
3,476
10,751
11,851
Other segment items
3,547
3,574
10,824
9,698
Interest expense, net
800
1,635
3,183
4,393
(Benefit from) provision for income taxes
( 280 )
—
154
—
Segment income
$
27,900
$
12,421
$
98,959
$
3,144
There is no reconciling items or adjustments between segment income presented above and net income as presented in our statements of operations. The CODM does not review assets in evaluating the segment results and therefore such information is not presented.
For details of revenues disaggregated by category, see “Note 3 – Revenues.”
Employee related expenses primarily comprised salaries, employee benefits, other employee related expenses and stock-based compensation expense. For details of stock-based compensation expense, see “Note 6 – Stock-Based Compensation.” Other segment items for the periods presented primarily comprised travel related expenses, business insurance, taxes and licenses, and facility related expenses.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.