Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS
CONDENSED CONSOLIDA TED BALANCE SHEETS
(In thousands, except per share amounts)
(Unaudited)
March 31, 2026
December 31, 2025
Assets
Current assets:
Cash and cash equivalents
$
36,997
$
47,872
Short-term investments
50,240
41,106
Accounts receivable, net
5,040
216
Inventories
3,384
3,743
Prepaid expenses and other current assets
5,694
6,136
Total current assets
101,355
99,073
Long-term investments
8,026
20,160
Other assets
248
361
Total assets
$
109,629
$
119,594
Liabilities, redeemable non-controlling interests and deficit
Current liabilities:
Accounts payable
$
5,094
$
3,745
Accrued and other current liabilities
17,340
20,183
Deferred revenue
5,680
5,314
Total current liabilities
28,114
29,242
Product development obligations
19,249
19,560
Deferred revenue, net of current
4,075
255
Liability related to sale of future revenues, non-current
67,405
65,980
Other long-term liabilities
76
82
Total liabilities
118,919
115,119
Commitments and Contingencies (Note 10)
Redeemable non-controlling interests
21,480
21,480
Stockholders’ deficit:
Preferred stock, $ 0.01 par value; 125,000 shares authorized; no shares issued
and outstanding at March 31, 2026 and December 31, 2025
—
—
Common stock, $ 0.01 par value; 225,000 shares authorized at March 31, 2026 and December 31, 2025; 4,048 and 4,047 shares issued and outstanding at March 31, 2026 and December 31, 2025
40
1,012
Additional paid-in capital
1,679,295
1,677,179
Accumulated other comprehensive loss
( 1,893
)
( 2,182
)
Accumulated deficit
( 1,721,245
)
( 1,706,047
)
Total stockholders’ deficit attributable to Kyntra Bio
( 43,803
)
( 30,038
)
Nonredeemable non-controlling interests
13,033
13,033
Total deficit
( 30,770
)
( 17,005
)
Total liabilities, redeemable non-controlling interests and deficit
$
109,629
$
119,594
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
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KYNTRA BIO, INC.
CONDENSED CONSOLIDATED S TATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended March 31,
2026
2025
Revenue:
Development and other revenue
$
246
$
144
Drug product revenue, net
3,492
2,595
Total revenue
3,738
2,739
Operating costs and expenses:
Cost of goods sold
4,106
252
Research and development
7,566
9,175
Selling, general and administrative
5,862
8,106
Restructuring charge
22
126
Total operating costs and expenses
17,556
17,659
Loss from operations
( 13,818
)
( 14,920
)
Interest and other, net
Interest expense
( 2,427
)
( 2,257
)
Interest income and other income (expenses), net
1,113
413
Total interest and other, net
( 1,314
)
( 1,844
)
Loss from continuing operations before income taxes
( 15,132
)
( 16,764
)
Provision for income taxes
—
2
Loss from continuing operations
( 15,132
)
( 16,766
)
Income (loss) from discontinued operations, net of tax
( 66
)
21,405
Net income (loss)
$
( 15,198
)
$
4,639
Loss from continuing operations per share - basic and diluted
$
( 3.74
)
$
( 4.15
)
Income (loss) from discontinued operations per share - basic and diluted
( 0.02
)
5.30
Net income (loss) per share - basic and diluted
$
( 3.76
)
$
1.15
Weighted average number of common shares used to calculate
net income (loss) per share - basic and diluted
4,047
4,038
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
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KYNTRA BIO, INC.
CONDENSED CONSOLIDATED STATE MENTS OF COMPREHENSIVE INCOME (LOSS)
(In thousands)
(Unaudited)
Three Months Ended March 31,
2026
2025
Net income (loss)
$
( 15,198
)
$
4,639
Other comprehensive income (loss):
Foreign currency translation adjustments
395
1,299
Unrealized loss on investments, net of tax effect
( 106
)
( 1
)
Other comprehensive income, net of taxes
289
1,298
Comprehensive income (loss)
( 14,909
)
5,937
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
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KYNTRA BIO, INC.
CONDENSED CONSOLIDATED STATEMENT S OF CHANGES IN REDEEMABLE NON-CONTROLLING
INTERESTS AND STOCKHOLDERS’ DEFICIT
(In thousands, except share data)
(Unaudited)
For The Three Month Period
Common Stock
Additional
Paid-in
Accumulated
Other
Comprehensive
Accumulated
Nonredeemable
Non-Controlling
Total
Redeemable
Non-Controlling
Shares
Amount
Capital
Loss
Deficit
Interests
Deficit
Interests
Balance at
December 31, 2025
4,046,827
$
1,012
$
1,677,179
$
( 2,182
)
$
( 1,706,047
)
$
13,033
$
( 17,005
)
$
21,480
Net loss
—
—
—
—
( 15,198
)
—
( 15,198
)
Change in unrealized
gain or loss on
investments
—
—
—
( 106
)
—
—
( 106
)
—
Foreign currency
translation
adjustments
—
—
—
395
—
—
395
—
Shares issued from stock
plans, net of payroll
taxes paid
1,285
—
( 7
)
—
—
—
( 7
)
—
Stock-based
compensation
—
—
1,151
—
—
—
1,151
—
Other
—
( 972
)
972
—
—
—
—
—
Balance at
March 31, 2026
4,048,112
$
40
$
1,679,295
$
( 1,893
)
$
( 1,721,245
)
$
13,033
$
( 30,770
)
$
21,480
Balance at
December 31, 2024
4,036,678
$
1,009
$
1,668,620
$
( 5,732
)
$
( 1,889,499
)
$
20,487
$
( 205,115
)
$
21,480
Net income
—
—
—
—
4,639
—
4,639
—
Change in unrealized
gain or loss on
investments
—
—
—
( 1
)
—
—
( 1
)
—
Foreign currency
translation
adjustments
—
—
—
1,299
—
—
1,299
—
Shares issued from stock
plans, net of payroll
taxes paid
5,080
1
( 38
)
—
—
—
( 37
)
—
Issuance cost under
ATM Program
—
—
( 46
)
—
—
—
( 46
)
—
Stock-based
compensation
—
—
2,852
—
—
—
2,852
—
Balance at
March 31, 2025
4,041,758
$
1,010
$
1,671,388
$
( 4,434
)
$
( 1,884,860
)
$
20,487
$
( 196,409
)
$
21,480
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
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KYNTRA BIO, INC.
CONDENSED CONSOLIDATED S TATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
Three Months Ended March 31,
2026
2025
Operating activities
Net income (loss)
$
( 15,198
)
$
4,639
Adjustments to reconcile net income (loss) to net cash provided by (used in)
operating activities:
Depreciation
—
318
Amortization of finance lease right-of-use assets
7
9
Net accretion of premium and discount on investments
( 183
)
( 1
)
Investment loss in unconsolidated variable interest entity
—
554
Loss on divestiture
66
—
Stock-based compensation
1,151
2,852
Changes in operating assets and liabilities:
Accounts receivable, net
( 4,824
)
( 3,160
)
Inventories
359
2,859
Prepaid expenses and other current assets
443
52,584
Operating lease right-of-use assets
—
306
Other assets
106
648
Accounts payable
1,349
( 24,766
)
Accrued and other liabilities
( 2,453
)
( 31,706
)
Operating lease liabilities, current
—
( 220
)
Deferred revenues
4,186
( 4,142
)
Accrued interest expense related to sale of future revenues
1,028
1,702
Accrued interest for finance lease liabilities
( 7
)
( 6
)
Operating lease liabilities, non-current
—
( 169
)
Other long-term liabilities
83
418
Net cash provided by (used in) operating activities
( 13,887
)
2,719
Investing activities
Purchases of property and equipment
—
( 16
)
Cash paid related to divestiture
( 60
)
—
Purchases of available-for-sale securities
( 11,055
)
—
Proceeds from maturities of investments
14,133
—
Net cash provided by (used in) investing activities
3,018
( 16
)
Financing activities
Repayments of finance lease liabilities
—
( 5
)
Cash paid for payroll taxes on restricted stock unit releases
( 7
)
( 37
)
Payment of issuance cost under ATM Program
—
( 46
)
Net cash used in financing activities
( 7
)
( 88
)
Effect of exchange rate change on cash and cash equivalents
1
1,407
Net increase (decrease) in cash and cash equivalents
( 10,875
)
4,022
Total cash and cash equivalents at beginning of period
47,872
102,178
Total cash and cash equivalents at end of period
$
36,997
$
106,200
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
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KYNTRA BIO, INC.
NOTES TO THE CONDENSED CONSOL IDATED FINANCIAL STATEMENTS
(Unaudited)
1. Significant Accounting Policies
Description of Operations
Kyntra Bio, Inc. (“Kyntra Bio” or the “Company”) is a biopharmaceutical company focused on development of novel therapies in oncology and rare disease.
In January 2026, the Company announced its rebranding from “FibroGen, Inc.” to “Kyntra Bio, Inc.,” representing the next step of its transformation to focus on oncology and rare disease assets. On January 8, 2026, the Company’s common stock began trading under the new Nasdaq symbol “KYNB.”
The Company is developing FG-3246, a potential first-in-class antibody-drug conjugate (“ADC”) targeting CD46, for the treatment of metastatic castration-resistant prostate cancer (“mCRPC”) and potentially other cancers. This program also includes the development of FG-3180, an associated CD46-targeted positron emission tomography (“PET”) biomarker and imaging agent. The Company initiated a Phase 2 monotherapy dose optimization study of FG-3246 for the treatment of mCRPC, along with the exploratory sub-study of FG-3180, in the third quarter of 2025.
The Company and its collaboration partners developed roxadustat (爱瑞卓 ® , EVRENZO TM ), which is currently approved in Europe, Japan, the People’s Republic of China (“China”), and numerous other countries for the treatment of anemia in chronic kidney disease (“CKD”) patients on dialysis and not on dialysis.
On August 29, 2025, the Company closed the sale of its China operations through FibroGen International (Hong Kong) Ltd. (“FibroGen International”) to AstraZeneca Treasury Limited pursuant to the share purchase agreement entered into by the Company and AstraZeneca Treasury Limited on February 20, 2025, as amended (the “Share Purchase Agreement”) for a total consideration of $ 220.4 million comprised of $ 85.0 million in enterprise value and $ 135.4 million in net cash held in China. AstraZeneca AB (“AstraZeneca”) was the Company’s long-time commercialization partner for roxadustat in greater China. This sale included all of its roxadustat assets in China, including FibroGen International’s subsidiary FibroGen (China) Medical Technology Development Co., Ltd (“FibroGen Beijing”) and its 51.1 % interest in Beijing Falikang Pharmaceutical Co. Ltd. (“Falikang”). For additional details, refer to Note 2, Discontinued Operations and Divestiture.
The Company has retained the rights to roxadustat in the United States of America (“U.S.”), Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas Pharma Inc. (“Astellas”). Astellas is commercializing roxadustat (EVRENZO TM ) in Europe and Japan to treat anemia under two development and commercialization license agreements: one for Japan, and one for Europe, the Commonwealth of Independent States, the Middle East and South Africa.
The Company continues to advance its development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndromes (“MDS”), a high-value indication with significant unmet medical need. The Company is now finalizing the Phase 3 trial protocol for roxadustat for the treatment of anemia in patients with lower-risk MDS and high transfusion burden after receiving further comments from the FDA.
The FDA granted roxadustat Orphan Drug Designation for the treatment of MDS in December 2025.
Basis of Presentation and Principles of Consolidation
The unaudited condensed consolidated financial statements and related disclosures have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) applicable to interim financial reporting and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U.S. Securities and Exchange Commission (“SEC”) and, therefore, do not include all information and footnote disclosures normally included in the annual consolidated financial statements. The financial information included herein should be read in conjunction with the consolidated financial statements and related notes in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed on March 16, 2026.
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The condensed consolidated financial statements include the accounts of the Company, its wholly-owned subsidiaries and its majority-owned subsidiaries, as well as any variable interest entity (“VIE”) for which Kyntra Bio is the primary beneficiary. All inter-company transactions and balances have been eliminated in consolidation.
The Company operates as one reportable segment — the development and commercialization of novel therapeutics to treat serious unmet medical needs.
Discontinued Operations
On February 20, 2025, the Company entered into the Share Purchase Agreement with AstraZeneca Treasury Limited pursuant to which the Company and its subsidiary FibroGen China Anemia Holdings, Ltd. agreed to sell all of the issued and outstanding equity interests of FibroGen International to AstraZeneca Treasury Limited (the “Transaction”). This sale included all of the Company’s roxadustat assets in China, including FibroGen International’s subsidiary FibroGen Beijing and its 51.1 % interest in Falikang. The Transaction was closed on August 29, 2025 for a total consideration of $ 220.4 million, subject to certain customary adjustments as set forth in the purchase agreement, comprised of $ 85.0 million in enterprise value and $ 135.4 million in net cash held in China .
The Company analyzed the quantitative and qualitative factors and concluded that the sale of FibroGen International represents a strategic shift in the Company’s business and qualified as a discontinued operation since December 31, 2024. As a result, the Company determined that FibroGen International met the “discontinued operations” criteria in accordance with Financial Accounting Standard Board (“FASB”) Accounting Standards Codification (“ASC”) 205, Presentation of Financial Statements. Accordingly, the operating results related to FibroGen International and the gain (loss) related to the Transaction are classified as discontinued operations, and have been reflected as discontinued operations in the condensed consolidated statements of operations for all periods presented. See Note 2, Discontinued Operations and Divestiture , for related disclosures. Unless otherwise noted, discussion in the notes to the condensed consolidated financial statements, relates to solely to the Company’s continuing operations.
Reverse Stock Split
On June 16, 2025, the Company effected a 1-for-25 reverse stock split (the “Reverse Stock Split”). The Reverse Stock Split reduced the number of issued and outstanding shares of common stock from approximately 101.1 million shares to approximately 4.0 million shares. Proportionate adjustments have been made to the number of shares available for issuance under the Company’s equity incentive plans as well as outstanding equity awards, in accordance with their respective terms. All share amounts have been retroactively adjusted in the condensed consolidated financial statements and the notes to the condensed consolidated financial statements, where applicable, to reflect the Reverse Stock Split.
Liquidity and Going Concern
The unaudited condensed consolidated financial statements are prepared in accordance with the U.S. GAAP applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Based on its current operating plan, the Company believes that its existing cash and cash equivalents will be sufficient to fund the Company’s planned operating requirements for at least the 12 months following the issuance of the financial statements for March 31, 2026.
Use of Estimates
The preparation of the condensed consolidated 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 at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The more significant areas requiring the use of management estimates and assumptions include valuation and recognition of revenue and deferred revenue, specifically, estimates in variable consideration for drug product sales. 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. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements include all normal recurring adjustments necessary for a fair statement of its financial position, results of operations and cash flows for the interim periods presented.
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Significant Accounting Policies
The accounting policies used by the Company in its presentation of interim financial results are consistent with those presented in Note 2 to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed on March 16, 2026.
Net Income (Loss) per Share
Potential common shares that would have the effect of increasing diluted earnings per share are considered to be anti-dilutive and as such, these shares are not included in the calculation of diluted earnings per share. The Company reported a loss from continuing operations for each of the three months ended March 31, 2026 and 2025. Therefore, dilutive common shares are not assumed to have been issued since their effect is anti-dilutive for these periods.
Diluted weighted average shares excluded the following potential common shares related to s tock options, service-based restricted stock units (“RSUs”), performance-based RSUs (“PRSUs”), total shareholder return (“TSR”) awards and shares to be purchased under the 2014 Employee Stock Purchase Plan (“ESPP”) for the periods presented as they were anti-dilutive (in thousands):
Three Months Ended March 31,
2026
2025
Employee stock options
480
515
RSUs, PRSUs and TSR awards
42
48
522
563
Risks and Uncertainties
The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, the results of clinical trials and the achievement of milestones, research developments, actions by regulatory authorities, market acceptance of the Company’s product candidates, competition from other products and larger companies, the liquidity and capital resources of the Company, intellectual property protection for the Company's proprietary technology, strategic relationships, and dependence on key individuals, suppliers, clinical organization, and other third parties.
Recently Issued Accounting Guidance Not Yet Adopted
In November 2024, the FASB issued Accounting Standards Update (“ASU”) 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40), and relevantly 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 guidance requires entities to disaggregate operating expenses into specific categories to provide enhanced transparency into the nature and function of expenses. This guidance is effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. This guidance should be applied either prospectively to financial statements issued for reporting periods after the effective date or retrospectively to any or all prior periods presented in the financial statements. The Company is currently in the process of evaluating the effects of this guidance on its related disclosures.
2. Discontinued Operations and Divestiture
On February 20, 2025, the Company entered into the Share Purchase Agreement with AstraZeneca Treasury Limited, pursuant to which the Company and its subsidiary FibroGen China Anemia Holdings, Ltd. agreed to sell all of the issued and outstanding equity interests of FibroGen International to AstraZeneca Treasury Limited. This sale included all of the Company’s roxadustat assets in China, including FibroGen International’s subsidiary FibroGen Beijing and its 51.1 % interest in Falikang. The Company determined that FibroGen International met the “held for sale” criteria and the “discontinued operations” criteria in accordance with FASB ASC 205, Presentation of Financial Statements , as of December 31, 2024. Accordingly, the operating results related to the FibroGen International are classified as discontinued operations, and have been reflected as discontinued operations in the condensed consolidated statements of operations.
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The Transaction was closed on August 29, 2025 for a total consideration of $ 220.4 million comprised of $ 85.0 million in cash for the enterprise value of FibroGen International and $ 135.4 million in net cash held in China. The total consideration included a $ 210.4 million in cash paid at closing, and a total of $ 10.0 million cash payable by AstraZeneca at the closing subject to holdbacks of: (i) a $ 6.0 million holdback to offset final net cash adjustments which will be released following a customary adjustment process approximately 90 days post-closing (as such time may be extended for the parties to mutually agree upon final adjustments), and (ii) a $ 4.0 million holdback to satisfy any indemnity claims, which will be released, net of any claims paid or unresolved, nine months after the closing. The Company does not expect such adjustments to be material, therefore have recorded the holdbacks as other receivable . On November 6, 2025, the Company received a $ 6.4 million payment from AstraZeneca, which is in full satisfaction of the first holdback of $ 6.0 million, plus $ 0.4 million that was an additional payment following the final net cash adjustments after closing. The second holdback of $ 4.0 million was included in the prepaid expenses and other current assets on the condensed consolidated balance sheets as of March 31, 2026 and December 31, 2025, respectively.
Historical Agreements with AstraZeneca and China Performance Obligation
In July 2013, the Company entered into a collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed under the Astellas Europe Agreement and Astellas Japan Agreement as discussed below in Note 3, Collaboration Agreements, License Agreement and Revenues, (“AstraZeneca U.S./RoW Agreement”). Later in 2024, the Company and AstraZeneca entered into an agreement to terminate the AstraZeneca U.S./RoW Agreement, effective as of February 25, 2024 (“AstraZeneca Termination and Transition Agreement”), as amended and restated on August 29, 2025. Neither party incurred any early termination penalties.
In July 2013, the Company (through its subsidiaries affiliated with China) entered into a collaboration agreement with AstraZeneca for roxadustat for the treatment of anemia in China (“AstraZeneca China Agreement”).
Prior to the AstraZeneca Termination and Transition Agreement, the Company evaluated under the ASC 606 and accounted for the AstraZeneca U.S./RoW Agreement and the AstraZeneca China Agreement as a single arrangement with the presumption that two or more agreements executed with a single customer at or around the same time should be presumed to be a single arrangement. The promises identified under the AstraZeneca China Agreement, including the license, co-development services and manufacturing of commercial supplies have been bundled into a single performance obligation (“China Performance Obligation”).
In July 2020, FibroGen China Anemia Holdings, Ltd., FibroGen Beijing, FibroGen International, and AstraZeneca entered into an amendment to the AstraZeneca China Agreement, relating to the development and commercialization of roxadustat in China (the “AstraZeneca China Amendment”). Under the AstraZeneca China Amendment, in 2020, FibroGen Beijing and AstraZeneca completed the establishment of a jointly owned entity, Falikang, which performed roxadustat distribution, as well as conducted sales and marketing through AstraZeneca.
Substantially all direct roxadustat product sales to distributors in China were made by Falikang, while FibroGen Beijing continued to sell roxadustat product directly in limited areas in China. Product revenue, net, which is included in the discontinued operations, consists primarily of revenues from sales of roxadustat commercial product to Falikang. Substantially all direct roxadustat product sales to distributors in China were made by Falikang. The net transaction price for FibroGen Beijing’s product sales to Falikang was based on a gross transaction price, adjusted for the estimated profit share.
The roxadustat sales to Falikang marked the beginning of the Company’s China Performance Obligation under the Company’s agreements with AstraZeneca . Product revenue was based on the transaction price of the China Performance Obligation. Revenue was recognized when control of the product was transferred to Falikang, in an amount that reflects the allocation of the transaction price to the performance obligation satisfied during the reporting period. Periodically, the Company updated its assumptions such as total sales quantity, timing of China’s volume-based purchasing program, performance period, gross transaction price, profit share and other inputs including foreign currency translation impact, among others. Any net transaction price in excess of the revenue recognized was added to the deferred balance, and recognized in the periods as the performance obligation was satisfied.
Upon the divestiture of FibroGen International on August 29, 2025, the performance obligation to AstraZeneca was completely satisfied upon the closing of the divestiture, and all the previously deferred revenues were recognized as revenue during the third quarter of 2025.
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Financial Information of the Discontinued Operations
The financial results of the discontinued operations with respect to FibroGen International reflected in the condensed consolidated statements of operations for the three months ended March 31, 2026 and 2025 were as follows (in thousands):
Three Months Ended March 31,
2026
2025
Revenue:
Product revenue, net
$
—
$
39,818
Operating costs and expenses:
Cost of goods sold
—
5,403
Research and development
—
759
Selling, general and administrative
—
7,464
Total operating costs and expenses
—
13,626
Income from operations
—
26,192
Interest and other, net
Interest expense
—
( 2,951
)
Loss on divestiture
( 66
)
—
Interest income and other income (expenses), net
—
( 1,282
)
Total interest and other, net
( 66
)
( 4,233
)
Income (loss) before income taxes
( 66
)
21,959
Provision for income taxes
—
—
Investment loss in unconsolidated variable interest entity
—
( 554
)
Income (loss) from discontinued operations, net of tax
$
( 66
)
$
21,405
The product revenue, net, consists primarily of revenues from sales of roxadustat commercial product to Falikang, a distribution entity jointly owned by AstraZeneca and FibroGen Beijing, as discussed above. Falikang was an unconsolidated VIE accounted for as an equity method investment, and considered as a related party to the Company. The net product revenue from sales to Falikang was $ 36.9 million for the three months ended March 31, 2025. The other income from Falikang were immaterial for the three months ended March 31, 2025. The investment loss in Falikang was $ 0.6 million for the three months ended March 31, 2025.
The significant non-cash items and capital expenditures for the discontinued operations with respect to FibroGen International included in the condensed consolidated statements of cash flows for the three months ended March 31, 2025 were as follows (in thousands):
Three Months Ended March 31,
2025
Depreciation
$
318
Investment income in unconsolidated variable interest entity
554
Stock-based compensation
$
344
3. Collaboration Agreements, License Agreement and Revenues
Astellas Agreements
Astellas Japan Agreement
In June 2005, the Company entered into a collaboration agreement with Astellas for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Astellas Japan Agreement”). Under this agreement, Astellas agreed to pay license fees, other upfront consideration and various milestone payments, totaling $ 172.6 million . The Astellas Japan Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range of the list price published by Japan’s Ministry of Health, Labour and Welfare, adjusted for certain elements, after commercial launch.
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The aggregate amount of consideration received under the Astellas Japan Agreement through March 31, 2026 totaled $ 105.1 million , excluding drug product revenue that is discussed under the Drug Product Revenue, Net section below. Based on its current development plans for roxadustat in Japan, the Company does not expect to receive most or all of the additional potential milestones under the Astellas Japan Agreement.
Amounts recognized as license revenue and development revenue under the Astellas Japan Agreement were no t material for the three months ended March 31, 2026 and 2025.
The transaction price related to consideration received through March 31, 2026 and accounts receivable has been allocated to each of the performance obligations under the Astellas Japan Agreement, including $ 100.3 million for license and $ 17.1 million for co-development.
There was no license revenue or development revenue resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods for the three months ended March 31, 2026 under the Astellas Japan Agreement. The Company does no t expect material variable consideration from estimated future co-development billing beyond the development period in the transaction price related to the Astellas Japan Agreement.
In 2018, the Company and Astellas entered into an amendment to the Astellas Japan Agreement that allows Astellas to manufacture roxadustat drug product for commercialization in Japan (the “Astellas Japan Amendment”). The related drug product revenue is described under the Drug Product Revenue, Net section below.
Astellas Europe Agreement
In April 2006, the Company entered into a separate collaboration agreement with Astellas for the development and commercialization of roxadustat for the treatment of anemia in Europe, the Middle East, the Commonwealth of Independent States and South Africa (“Astellas Europe Agreement”). Under the terms of the Astellas Europe Agreement, Astellas agreed to pay license fees, other upfront consideration and various milestone payments, totaling $ 745.0 million . U nder the Astellas Europe Agreement, Astellas committed to fund 50 % of joint development costs for Europe and North America, and all territory-specific costs. The Astellas Europe Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range .
The aggregate amount of consideration received under the Astellas Europe Agreement through March 31, 2026 totaled $ 685.0 million , excluding drug product revenue that is discussed under the Drug Product Revenue, Net section below. Based on its current development plans for roxadustat in Europe, the Company does not expect to receive most or all of the additional potential milestones under the Astellas Europe Agreement.
Amounts recognized as license revenue and development revenue under the Astellas Europe Agreement were no t material for the three months ended March 31, 2026 and 2025.
The transaction price related to consideration received through March 31, 2026 and accounts receivable has been allocated to each of the performance obligations under the Astellas Europe Agreement, including $ 619.0 million for license and $ 288.9 million for co-development.
There was no license revenue or development revenue resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods for three months ended March 31, 2026 under the Astellas Europe Agreement. The Company does no t expect material variable consideration from estimated future co-development billing beyond the development period in the transaction price related to the Astellas Europe Agreement.
In 2021, the Company entered into an EU Supply Agreement with Astellas under the Astellas Europe Agreement (“Astellas EU Supply Agreement”) to define general forecast, order, supply and payment terms for Astellas to purchase roxadustat bulk drug product from the Company in support of commercial supplies. The related drug product revenue is described under the Drug Product Revenue, Net section below.
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Drug Product Revenue, Net
Drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to Astellas and AstraZeneca was as follows for the three months ended March 31, 2026 and 2025 (in thousands):
Three Months Ended March 31,
2026
2025
Astellas Japan Agreement
$
( 2,191
)
$
1,781
Astellas Europe Agreement
5,683
814
Drug product revenue, net
$
3,492
$
2,595
Astellas Japan Agreement
The Company updates its estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment at each balance sheet date. As a result, the Company recorded a reduction to the drug product revenue of $ 2.2 million f or the three months ended March 31, 2026. Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect changes in the listed price, among others.
For the three months ended March 31, 2025, the Company updated its estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment, and accordingly recorded an adjustment to the drug product revenue of $ 1.8 million. Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect the changes in the estimated yield from the manufacture of bulk product tablets, among others.
As of March 31, 2026, t he balances related to the API price true-up under the Astellas Japan Agreement were $ 3.8 million in accrued liabilities, representing the Company’s best estimate of the timing for these amounts to be paid. As of December 31, 2025, the balances related to the API price true-up under the Astellas Japan Agreement were $ 1.6 million in accrued liabilities.
Astellas Europe Agreement
The Company transferred bulk drug product for commercial purposes under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement in the prior years. The Company recognized the related fully burdened manufacturing costs as drug product revenue in the respective periods and recorded the constrained transaction price in deferred revenue due to a high degree of uncertainty associated with the variable consideration for revenue recognition purposes. The Company updates its estimate of variable consideration related to the bulk drug product transferred in prior years at each balance sheet date.
During the three months ended March 31, 2026, the Company recorded $ 3.3 million in drug product revenue for intermediates under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement, and received cash during the same quarter . Corresponding to the drug product revenue, the Company recorded the related cost of goods sold of $ 3.3 million during the three months ended March 31, 2026.
In addition, during the three months ended March 31, 2026 , the Company transferred bulk drug product for commercial purposes under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement, and recognized the related fully-burdened manufacturing costs of $ 0.9 million as drug product revenue, and recorded $ 6.2 million as deferred revenue due to a high degree of uncertainty associated with the variable consideration for revenue recognition purposes. In addition, the Company updated its estimate of variable consideration related to the bulk drug product transferred in prior years. Specifically, the change in estimated variable consideration was based on the bulk drug product held by Astellas at the period end, adjusted to reflect the changes in the estimated transfer price, forecast information, shelf-life estimates and other items. As a result, for the three months ended March 31, 2026, the Company reclassified $ 0.5 million from the related deferred revenue to accrued liabilities. As of March 31, 2026, the balances related to the bulk drug product price true-up under the Astellas Europe Agreement and the Astellas EU Supply Agreement were $ 1.9 million in a ccrued liabilities, representing the Company’s best estimate that these amounts will be paid within the next 12 months. As of December 31, 2025, the related balance in accrued liabilities was $ 5.4 million, $ 3.8 million of which was paid to Astellas in the first quarter of 2026.
The Company recognized royalty revenue of $ 1.5 million and $ 0.8 million as drug product revenue from the deferred revenue under the Astellas Europe Agreement for the three months ended March 31, 2026 and 2025, respectively. It is the Company’s best estimate that the remainder of the deferred revenue will be recognized as revenue when uncertainty is resolved, based on the performance of roxadustat product sales in the Astellas territory.
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The following table includes a roll-forward of the above-mentioned deferred revenues that are considered as contract liabilities related to drug product (in thousands):
Balance at
December 31, 2025
Additions
Recognized as Revenue
Reclassified to Accrued Liability / Accounts Payable
Balance at
March 31, 2026
Drug product revenue - deferred revenue:
Astellas Europe Agreement
$
( 5,569
)
$
( 6,164
)
$
1,504
$
474
$
( 9,755
)
4. Consolidated Variable Interest Entity - Fortis
In May 2023 (the “Option Acquisition Date”), the Company entered into an exclusive option agreement to acquire Fortis Therapeutics, Inc. (“Fortis”) with its novel Phase 1 ADC, FOR46 (now referred to as “FG-3246”) that targets CD46, a novel epitope preferentially expressed on certain cancer cells. FG-3246 is in development for the treatment of mCRPC with potential applicability in other solid tumors and hematologic malignancies. If the Company exercises the option to acquire Fortis, it will pay Fortis an option exercise payment of $ 80.0 million, and thereafter, legacy Fortis shareholders would be eligible to receive from the Company up to $ 200.0 million in contingent payments associated with the achievement of various regulatory approvals. If the Company acquires Fortis, it would also be responsible to pay University of California, San Francisco (“UCSF”), an upstream licensor to Fortis, development milestone fees and a single digit royalty on net sales of therapeutic or diagnostic products arising from the licensing arrangement between Fortis and UCSF . If the Company chooses not to acquire Fortis, its exclusive license to FG-3246 would expire.
Pursuant to an evaluation agreement entered into with Fortis concurrent with the option agreement (together the “Fortis Agreements”), the Company has exclusively licensed FG-3246 and will control and fund future research, development, including a Phase 2 clinical study sponsored by the Company, and manufacturing of FG-3246 during the option period (which ends on December 31, 2027). As part of the clinical development strategy, the Company will continue the work to develop a PET-based biomarker utilizing a radiolabeled version of the targeting antibody for patient selection.
Pursuant to the guidance under ASC 810, Consolidation (“ASC 810”), the Company determined that Fortis is a VIE and that the Company is the primary beneficiary of Fortis, as through the Fortis Agreements the Company has the power to direct activities that most significantly impact the economic performance of Fortis. Therefore, the Company consolidated Fortis starting from the Option Acquisition Date and continues to consolidate as of March 31, 2026.
Fortis has authorized and issued common shares and Series A preferred shares. The Company owned approximately 2 % of Fortis’ Series A preferred shares, which was acquired prior to the Option Acquisition Date and carried at zero cost. The non-controlling interests (“NCI”) attributable to the common shares is classified as nonredeemable NCI, as it is 100 % owned by third party shareholders. The NCI attributable to the approximately 98 % of Series A preferred shares owned by other investors are classified as redeemable NCI in temporary equity, as the preferred shares are redeemable by the non-controlling share holders upon occurrence of certain events out of the Company’s control.
Subsequent to the Option Acquisition Date, Fortis’ net income is allocated to its common shares and preferred shares based on their respective stated rights. Fortis’ net loss is allocated to its common shares only as the holders of preferred shares do not have a contractual obligation to absorb such losses.
As of March 31, 2026, total assets and liabilities of Fortis were immaterial. For the three months ended March 31, 2026 and 2025 , Fortis’ net income (losses) was immaterial.
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5. Fair Value Measurements
The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands):
March 31, 2026
Level 1
Level 2
Level 3
Total
Money market funds
$
34,567
$
—
$
—
$
34,567
Corporate bonds
—
26,712
—
26,712
Commercial paper
—
4,585
—
4,585
U.S. government bonds
20,989
5,980
—
26,969
Total
$
55,556
$
37,277
$
—
$
92,833
December 31, 2025
Level 1
Level 2
Level 3
Total
Money market funds
$
24,302
$
—
$
—
$
24,302
Corporate bonds
—
27,817
—
$
27,817
Commercial paper
—
17,797
—
17,797
U.S. government bonds
31,922
4,991
—
36,913
Total
$
56,224
$
50,605
$
—
$
106,829
The Company’s Level 2 investments are valued using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar investments, issuer credit spreads, benchmark investments, prepayment/default projections based on historical data and other observable inputs. During the three months ended March 31, 2026 and 2025 , a total of $ 6.0 million and $ 6.5 million, respectively, of U.S. treasury notes and bills were transferred from Level 1 to Level 2 as such instruments were changed to off-the-run when they were issued before the most recent issue and were still outstanding at measurement day.
6. Balance Sheet Components
Cash and Cash Equivalents
Cash and cash equivalents consisted of the following (in thousands):
March 31, 2026
December 31, 2025
Cash
$
2,430
$
2,309
Commercial paper
—
11,272
Money market funds
34,567
24,302
U.S. government bonds
—
9,989
Total cash and cash equivalents
$
36,997
$
47,872
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Investments
As of March 31, 2026 , the Company’s investments consist primarily of available-for-sale debt investments. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s investments by major investments type are summarized in the table below (in thousands):
March 31, 2026
Amortized Cost
Gross Unrealized
Holding Gains
Gross Unrealized
Holding Losses
Estimated
Fair Value
Corporate bonds
$
26,763
$
—
$
( 51
)
$
26,712
Commercial paper
4,585
—
—
4,585
U.S. government bonds
26,986
—
( 17
)
26,969
Total investments
$
58,334
$
—
$
( 68
)
$
58,266
December 31, 2025
Amortized Cost
Gross Unrealized
Holding Gains
Gross Unrealized
Holding Losses
Estimated
Fair Value
Corporate bonds
$
27,800
$
17
$
—
$
27,817
Commercial paper
6,525
—
—
6,525
U.S. government bonds
26,903
21
—
26,924
Total investments
$
61,228
$
38
$
—
$
61,266
The following table summarizes, for all available for sale securities in an unrealized loss position, the fair value and gross unrealized loss by length of time the security has been in a continual unrealized loss position (in thousands):
March 31, 2026
Less than 12 Months
12 Months or More
Total
Estimated
Fair Value
Gross Unrealized
Holding Losses
Estimated
Fair Value
Gross Unrealized
Holding Losses
Estimated
Fair Value
Gross Unrealized
Holding Losses
Corporate bonds
$
26,712
$
( 51
)
$
—
$
—
$
26,712
$
( 51
)
U.S. government bonds
$
20,989
$
( 17
)
$
—
$
—
$
20,989
$
( 17
)
Total
$
47,701
$
( 68
)
$
—
$
—
$
47,701
$
( 68
)
As of March 31, 2026 , the available-for-sale investments had remaining contractual maturities within two years .
The Company periodically assesses whether the unrealized losses on its available-for-sale investments were temporary. The Company considers factors such as the severity and the reason for the decline in value, the potential recovery period and its intent to sell. For debt securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses. Based on the results of its review, the Company did no t recognize any credit related losses or other impairment loss during the three months ended March 31, 2026 and 2025.
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
March 31, 2026
December 31, 2025
Holdback consideration receivable related to divestiture
$
4,000
$
4,000
Prepaid assets
1,138
1,015
Other current assets
556
1,121
Total prepaid expenses and other current assets
$
5,694
$
6,136
As of March 31, 2026 and December 31, 2025, the Company recorded a $ 4.0 million receivable in prepaid expenses and other current assets for the holdbacks related to the closing of the divestiture of FibroGen International. See Note 2, Discontinued Operations and Divestiture, for details.
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Accrued and Other Current Liabilities
Accrued and other current liabilities consisted of the following (in thousands):
March 31, 2026
December 31, 2025
Preclinical and clinical trial accruals
$
3,003
$
3,066
API and bulk drug product price true-up
5,716
6,977
Payroll and related accruals
1,477
3,983
Accrued restructuring charge
368
537
Professional services
4,125
2,465
Current portion of liability related to sale of future revenues
937
1,334
Other
1,714
1,821
Total accrued and other current liabilities
$
17,340
$
20,183
The accrued liabilities of $ 5.7 million and $ 7.0 million for API and bulk drug product price true-up as of March 31, 2026 and December 31, 2025, respectively, resulted from changes in estimated variable consideration associated with the API shipments fulfilled under the terms of the Astellas Japan Amendment, and the bulk drug product transferred under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement. See the Drug Product Revenue, Net section in Note 3, Collaboration Agreements, License Agreement and Revenues, for details.
7. Senior Secured Term Loan Facilities
In April 2023, the Company entered into a financing agreement (“Financing Agreement”) with investment funds managed by MSTV, as lenders (the “Lenders”), and Wilmington Trust, National Association, as the administrative agent, providing for senior secured term loan facilities, and received $ 74.1 million, representing a $ 75.0 million initial term loan (the “ Initial Term Loan”) , net of $ 0.9 million issuance costs.
The Initial Term Loan accrued interest at a fixed rate of 14.0 % per annum, payable monthly in arrears. The Initial Term Loan would mature on May 8, 2026 . The Initial Term Loan was subject to amortization payments. The Company was permitted to prepay the Initial Term Loan from time to time, in whole or in part, subject to payment of a make-whole amount equal to the unpaid principal amount of the portion of the Initial Term Loan being repaid or prepaid, plus accrued and unpaid interest of the portion of the Initial Term Loan being repaid or prepaid, plus an amount equal to the remaining scheduled interest payments due on such portion of the Initial Term Loan being repaid or prepaid as if such Initial Term Loan were to remain outstanding until the scheduled maturity date.
On August 29, 2025, upon the closing of the divestiture FibroGen International , the Company paid the Lenders a total of $ 80.9 million, including $ 75.0 million for paying off the senior secured term loan facilities, $ 0.4 million for outstanding interest and $ 5.5 million for related premium and fees .
The effective annual interest rate of the Initial Term Loan was 16.13 % for the three months ended March 31, 2025. The Company recorded interest expense of $ 3.0 million for the three months ended March 31, 2025, which was included in discontinued operations as the Company was required to repay the loan upon the closing of the divestiture of FibroGen International .
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8. Liability Related to Sale of Future Revenues
In November 2022, the Company entered into a Revenue Interest Financing Agreement (the “RIFA”) with an affiliate of NovaQuest Capital Management (“NovaQuest”), pursuant to which the Company granted NovaQuest 22.5 % of its drug product revenue and 10.0 % ( 20.0 % for fiscal year 2028 and thereafter) of its revenue from milestone payments that it is entitled to under the Astellas Agreements , for a consideration of $ 50.0 million (“Investment Amount”) before advisory fees.
In November 2022, the Company received the Investment Amount, net of initial issuance costs, and accounted for it as long-term debt based on the terms of the RIFA because the risks and rewards to NovaQuest are limited by the terms of the transaction. The related debt discount and transaction costs are amortized as interest expense based on the projected balance of the liability as of the beginning of each period. As payments are made to NovaQuest, the balance of the liability related to sale of future revenues is being effectively repaid over the life of the RIFA. The payments to NovaQuest are accounted for as a reduction of debt.
The Company may prepay its obligations to NovaQuest in full at any time during the term of RIFA. The prepayment amount varies from $ 80.0 million to $ 125.0 million less any revenue interest payments made up to such prepayment date. Under the RIFA the Company shall pay to NovaQuest up to a specified maximum amount (“Payment Cap”) of (a) $ 100.0 million, if the payment is made on or before December 31, 2028; (b) $ 112.5 million, if the payment is made on or after January 1, 2029, but on or before December 31, 2029; or (c) $ 125.0 million, if the payment is made after January 1, 2030.
After January 1, 2028, if the product (as defined) is not commercialized for a consecutive twelve-month period, then, the payments owed under the RIFA by the Company to NovaQuest for each fiscal year shall be the greater of: (i) the amount which would otherwise be due pursuant to revenue interest payments terms; or (ii) $ 10.0 million.
Before December 31, 2028, if the sum of all payments under the RIFA paid to NovaQuest, does not equal or exceed $ 62.5 million, then the Company shall pay NovaQuest the difference of these two amounts by no later than March 1, 2029. If, by no later than December 31, 2030, the sum of all payments under the RIFA paid to NovaQuest does not equal or exceed $ 125.0 million, then the Company shall pay NovaQuest the difference of these two amounts by no later than March 1, 2031.
NovaQuest will retain this entitlement until it has reached the Payment Cap, at which point 100 % of such revenue interest on future global net sales of Astellas will revert to the Company. Based on the current estimates of drug product revenue and revenue from milestone payments under the Astellas Agreements, and taking into the consideration of the terms discussed above, the Company anticipates reaching a Payment Cap up to $ 125.0 million by 2031.
Over the course of the RIFA, the effective interest rate is affected by the amount and timing of drug product revenue and revenue from milestone payments recognized, the changes in the timing of forecasted drug product revenue and revenue from milestone payments, and the timing of the Company’s payments to NovaQuest. On a quarterly basis, the Company reassesses the expected total revenue and the timing of such revenue, recalculates the amortization of debt discount and transactions costs and effective interest rate, and adjusts the accounting prospectively as needed. The Company’s estimated effective annual interest rate was 15.19 % as of March 31, 2026.
The following table summarizes the activities of the liability related to sale of future revenues for the three months ended March 31, 2026:
Three Months Ended March 31,
2026
Liability related to sale of future revenues - beginning balance
$
67,314
Interest paid
( 1,316
)
Interest expense recognized
2,344
Liability related to sale of future revenues - ending balance
68,342
Less: Current portion classified to accrued and other current liabilities
( 937
)
Liability related to sale of future revenues, non-current
$
67,405
During the three months ended March 31, 2026 and 2025, the Company recognized, under Astellas Agreements, development revenue of $ 0.2 million and $ 0.1 million , respectively, and drug product revenue of $ 3.5 million and $ 2.6 million, respectively. See Note 3, Collaboration Agreements, License Agreement and Revenue , for details.
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During the three months ended March 31, 2026 and 2025 , the Company recognized the related interest expense of $ 2.3 million and $ 2.2 million, respectively. During the three months ended March 31, 2026 and 2025 , the Company paid $ 1.3 million and $ 0.5 million accrued interest, respectively.
9 . Income Taxes
Provision for income taxes for the three months ended March 31, 2026 and 2025 were immaterial.
Based upon the weight of available evidence, which includes its historical operating performance, reported cumulative net losses since inception, the Company has established and continues to maintain a full valuation allowance against its net deferred tax assets as it does not currently believe that realization of those assets is more likely than not.
10. Commitments and Contingencies
Contract Obligations
As of March 31, 2026 , the Company had outstanding total non-cancelable purchase obligations of $ 1.5 million for manufacture and supply of roxadustat and $ 1.1 million for general purchases . The Company expects to fulfill its commitments under these agreements in the normal course of business, and as such, no liability has been recorded.
In addition, see Note 8, Liability Related to Sale of Future Revenues for details of the related obligations.
Legal Proceedings and Other Matters
From time to time, the Company is a party to various legal actions, both inside and outside the U.S., arising in the ordinary course of its business or otherwise. The Company accrues amounts, to the extent they can be reasonably estimated, that the Company believes will result in a probable loss (including, among other things, probable settlement value) to adequately address any liabilities related to legal proceedings and other loss contingencies. A loss or a range of loss is disclosed when it is reasonably possible that a material loss will incur and can be estimated, or when it is reasonably possible that the amount of a loss, when material, will exceed the recorded provision. The Company did not have any material accruals for any active legal action, in its condensed consolidated balance sheet as of March 31, 2026.
Between April 2021 and May 2021, five putative securities class action complaints were filed against the Company and certain of its former executive officers in the U.S. District Court for the Northern District of California. On October 17, 2023, the parties reached an agreement in principle to settle the class action at $ 28.5 million. The Court approved the settlement Plan of Allocation on May 28, 2024 and Plaintiffs’ motion for attorney’s fees on August 1, 2024. The court entered a class distribution order on January 1, 2025 and the amount was fully distributed during the first quarter of 2025. The settlement was fully covered by insurance.
In the fourth quarter of 2021, the Company received a subpoena from the SEC requesting documents related to roxadustat’s pooled cardiovascular safety data. The SEC followed up with a subpoena for additional documents in the second quarter of 2024. In May 2025, the Company entered into a settlement with the SEC. As part of the settlement, and without admitting or denying the findings in the settlement offer or administrative order to be issued by the SEC, the Company agreed to pay a $ 1.25 million civil penalty. In September 2025, the agreement was approved by the Commission and the Company has been making payments to the agreed upon payment schedule .
Between 2022 and 2024, the Company’s Board of Directors received seven litigation demands from purported shareholders of the Company, asking the Board of Directors to investigate and take action against certain current and former officers and directors of the Company for alleged wrongdoing based on the same allegations in the derivative and securities class action lawsuits. The litigation demands have been withdrawn.
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Indemnification Agreements
The Company enters into standard indemnification arrangements in the ordinary course of business, including for example, service, manufacturing and collaboration agreements. 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, including in connection with intellectual property infringement claims by any third party with respect to its technology. The term of these indemnification agreements is generally perpetual after the execution of the agreement. The Company has entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the extent permissible under applicable law.
There is currently one SEC complaint against the Company's former Chief Medical Officer in U.S. District Court. While the Company is not a party to this proceeding, pursuant to its indemnification agreement with the former officer, the Company is obligated to advance certain legal expenses and may be required to indemnify certain costs and judgments; however, certain judgments, settlements, or fines sought by the SEC would not be covered by the Company under the indemnification agreement.
As of March 31, 2026, the Company’s accrued liabilities related to these obligations were not material. The Company is unable to reasonably estimate the total amount of future indemnification costs beyond amounts currently accrued due to the early stage of the litigation and significant uncertainties regarding the duration, scope, and outcome of the proceedings.
11. Segment Information
The Company has one operating and reporting segment which primarily focuses on the development and commercialization of novel therapeutics to treat serious unmet medical needs. The Company has determined that the chief executive officer is the chief operating decision maker (“CODM”). The CODM assesses performance of the business, monitors budget versus actual results and manages and allocates resources to the Company’s operations using consolidated net income (loss) as the primary measurement. The CODM is regularly provided with entity-wide expense categories that are consistent with those found on the Company’s condensed consolidated statements of operations. These significant segment expenses include cost of goods sold, research and development expenses, selling, general and administrative expenses, and restructuring charge. Other segment items that are presented on the condensed consolidated statements of operations include interest expense, interest income and other income (expense), net, and provision for (benefit from) income taxes. The measure of segment assets is reported on the balance sheet as total consolidated assets.
12. Subsequent Event
The Company’s subsidiary, FibroGen Europe Oy (“FibroGen Europe”), has product development obligations to the Technology Development Center of the Republic of Finland (“TEKES”), which consist of 11 separate advances (each in the form of a note agreement) received by FibroGen Europe between 1996 and 2008 from TEKES (“TEKES loans”). These advances were granted on a project-by-project basis to fund various product development efforts undertaken by FibroGen Europe only. Kyntra Bio, Inc. is not a guarantor of these loans and they are non-recourse to Kyntra Bio, Inc. The principal or the accrued interest of these loans are not repayable by FibroGen Europe until it has distributable funds.
FibroGen Europe voluntarily submitted for bankruptcy to the Finnish bankruptcy court in April 2026. FibroGen Europe was declared bankrupt by a decision of the Helsinki District Court on April 16, 2026 and the court has appointed an estate administrator of the bankruptcy estate.
As of March 31, 2026 and December 31, 2025, the Company had U.S. Dollar equivalent of $ 10.9 million and $ 11.1 million of principal outstanding, respectively, and $ 8.4 million and $ 8.5 million of interest accrued, respectively, which were presented in the product development obligations line on the condensed consolidated balance sheets.
While the Company expects the above-mentioned bankruptcy process to result in an eventual relief of the TEKES loans, the definitive timing and the ultimate outcome of such debt relief remain uncertain. At this time, the Company cannot reasonably estimate the related financial effect on its consolidated financial position or results of operations.
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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.