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KYNTRA BIO, INC.

For the period ended Jun 30, 2026. Filed Aug 13, 2026.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2026 · Filed Aug 13, 2026

KYNB$3.73+1.9%Stored close · as of Nov 6, 2026

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Notes to the Condensed Consolidated Financial Statements (Unaudited)

NOTES TO THE CONDENSED CONSOL IDATED FINANCIAL STATEMENTS

  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®, EVRENZOTM), 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 3, 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 (EVRENZOTM) 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 has finalized the Phase 3 trial protocol for roxadustat for the treatment of anemia in patients with lower-risk MDS with high transfusion burden. The Company is continuing with preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late-stage program. The Company’s goal is to initiate the Phase 3 trial in the fourth quarter of 2026.

The U.S. Food and Drug Administration 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.

The interim financial data as of June 30, 2026 and for the three and six months ended June 30, 2026 are unaudited. In the opinion of management, the interim data includes all adjustments, consisting of normal recurring adjustments, necessary for a fair statement of the results for the interim periods. The condensed consolidated balance sheet presented as of December 31, 2025 has been derived from the consolidated audited financial statements as of that date.

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 deconsolidates its subsidiary or business in accordance with Accounting Standards Codification (“ASC”) 810, Consolidation (“ASC 810”), as of the date the Company ceased to have a controlling financial interest in the subsidiary. Upon deconsolidation, all assets and liabilities of the former subsidiary are derecognized, any retained investment is recorded at its fair value, and any resulting gain or loss is recognized in the condensed consolidated statements of operations.

The Company operates asone 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”) 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 3, Discontinued Operations and Divestiture, for related disclosures. Unless otherwise noted, discussion in the notes to the condensed consolidated financial statements, relates solely to the Company’s continuing operations.

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 June 30, 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.

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

The Company reported net income from continuing operations for the three months ended June 30, 2026. The effect of potentially dilutive securities to the diluted weighted-average shares outstanding is taken into consideration and the resulting impact on diluted net income per share were immaterial. 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 the six months ended June 30, 2026 and the three and six months ended June 30, 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 stock 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 June 30,Six Months Ended June 30,
2026202520262025
Employee stock options544490512500
RSUs, PRSUs and TSR awards56364942
ESPP35—35—
635526596542

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.

  1. Deconsolidation of European Subsidiary

In April 2026, the Company’s subsidiary, FibroGen Europe Oy (“FibroGen Europe”), voluntarily filed for bankruptcy with the Finnish bankruptcy court. On April 16, 2026, the Helsinki District Court declared FibroGen Europe bankrupt and appointed an estate administrator to oversee the bankruptcy estate. As a result, the Company determined that it no longer maintained a controlling financial interest in FibroGen Europe and therefore deconsolidated the subsidiary effective April 16, 2026 in accordance with ASC 810. The Company determined that the deconsolidation did not represent a strategic shift that has a major effect on its operations and financial results. Accordingly, the results of the subsidiary have not been presented as discontinued operations.

FibroGen Europe had product development obligations to the Technology Development Center of the Republic of Finland (“TEKES”), consisting of 11 separate advances received between 1996 and 2008 pursuant to note agreements (the “TEKES Loans”). The advances were granted on a project-by-project basis to fund various product development activities undertaken solely by FibroGen Europe. Kyntra Bio was not a guarantor of the TEKES Loans, and the obligations were non-recourse to Kyntra Bio. Repayment of principal and accrued interest was not required unless FibroGen Europe had distributable funds.

FibroGen Europe’s balance sheet before the deconsolidation primarily included $19.2 million of the above-mentioned TEKES Loans, $12.5 million nonredeemable non-controlling interest, and $0.7 million of cumulative foreign currency translation adjustments. Upon deconsolidation, the Company derecognized the subsidiary’s assets and liabilities and recognized a $30.9 million gain on deconsolidation in the condensed consolidated statements of operations for thethree and six months ended June 30, 2026.

Upon deconsolidation, the Company measured any retained equity interest in FibroGen Europe at fair value in accordance with ASC 810 and determined that the fair value of such retained interest waszero as of April 16, 2026. Following deconsolidation, the Company accounts for any retained equity interest in FibroGen Europe under ASC 321, Investments — Equity Securities. The carrying value of the Company’s retained equity interest in FibroGen Europe remained zero as of June 30, 2026.

  1. 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.

The Transaction was closed on August 29, 2025 for atotal consideration of $220.4 million comprised of $85.0 million in cash for the enterprise value of FibroGen Internationaland $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. On June 2, 2026, the Company received a $4.0 million payment from AstraZeneca, which is in full satisfaction of the final holdback. Such amount was included in the prepaid expenses and other current assets on the condensed consolidated balance sheets as of December 31, 2025.

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 4, 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.

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 thethree and six months ended June 30, 2026 and 2025 were as follows (in thousands):

Three Months Ended June 30,Six Months Ended June 30,
2026202520262025
Revenue:
Product revenue, net$—19,655$—$59,472
Operating costs and expenses:
Cost of goods sold—4,290—9,692
Research and development—542—1,301
Selling, general and administrative—6,074—13,538
Total operating costs and expenses—10,906—24,531
Income from operations—8,749—34,941
Interest and other, net
Interest expense—(2,964)—(5,915)
Loss on divestiture——(66)—
Interest income and other income (expenses), net—(1,367)—(2,649)
Total interest and other, net—(4,331)(66)(8,564)
Income (loss) before income taxes—4,418(66)26,377
Provision for income taxes————
Investment income in unconsolidated variable interest entity—1,662—1,108
Income (loss) from discontinued operations, net of tax$—$6,080$(66)$27,485

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 $16.4 million and $53.3 million for the three and six months ended June 30, 2025, respectively. The other income from Falikang were immaterial for the three and six months ended June 30, 2025. The investment income in Falikang was $1.7 million and $1.1 million for the three and six months ended June 30, 2025, respectively.

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 six months ended June 30, 2025 were as follows (in thousands):

Six Months Ended June 30,
Depreciation$530
Investment income in unconsolidated variable interest entity(1,108)
Impairment of property and equipment2,062
Stock-based compensation$943
  1. Collaboration Agreements, License Agreement and Revenues

Astellas Agreements

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) inthe low 20% range of the list price published by Japan’s Ministry of Health, Labour and Welfare, adjusted for certain elements, after commercial launch.

The aggregate amount of consideration received under the Astellas Japan Agreement through June 30, 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 werenot material for thethree and six months ended June 30, 2026 and 2025.

The transaction price related to consideration received through June 30, 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 wasno 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 thethree months ended June 30, 2026 under the Astellas Japan Agreement. The Company doesnot 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.

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. Under 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 thelow 20% range.

The aggregate amount of consideration received under the Astellas Europe Agreement through June 30, 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 werenot material for thethree and six months ended June 30, 2026 and 2025.

The transaction price related to consideration received through June 30, 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$289.0 million for co-development.

There wasno 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 June 30, 2026 under the Astellas Europe Agreement. The Company doesnot 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.

Drug Product Revenue, Net

Drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to Astellas was as follows for the three and six months ended June 30, 2026 and 2025 (in thousands):

Three Months Ended June 30,Six Months Ended June 30,
2026202520262025
Astellas Japan Agreement$(2,935)$44$(5,126)$1,825
Astellas Europe Agreement1,3581,1717,0411,986
Drug product revenue, net$(1,577)$1,215$1,915$3,811

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$2.9 million for the three months ended June 30, 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 estimated bulk product strength mix intended to be manufactured by Astellas, and foreign exchange impacts, among others.

For the three months ended March 31, 2026, the Company updated its estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment, and accordingly recordeda reduction to the drug product revenue of $2.2 million. 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 June 30, 2025, the adjustment to the drug product revenue was immaterial.

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 recordedan 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 June 30, 2026, the balances related to the API price true-up under the Astellas Japan Agreement were $2.9 million inaccrued 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.

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.

For the six months ended June 30, 2026, 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 six months ended June 30, 2026, the Company reclassified $0.8 million from the related deferred revenue to accrued liabilities.

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.

As of June 30, 2026, the balances related to the bulk drug product price true-up under the Astellas Europe Agreement and the Astellas EU Supply Agreement were$2.3 million in accrued 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$1.4 million and$1.2 million as drug product revenue from the deferred revenue under the Astellas Europe Agreement for the three months ended June 30, 2026 and 2025, and $2.9 million and$2.0 million for the six months ended June 30, 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.

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 atDecember 31, 2025AdditionsRecognized as RevenueReclassified to Accrued Liability / Accounts PayableBalance atJune 30, 2026
Drug product revenue - deferred revenue:
Astellas Europe Agreement$(5,569)$(6,164)$2,862$833$(8,038)
  1. Fair Value Measurements

The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands):

Level 1Level 2Level 3Total
Money market funds$47,847$—$—$47,847
Corporate bonds—26,679—26,679
U.S. government bonds18,007——18,007
Total$65,854$26,679$—$92,533
Level 1Level 2Level 3Total
Money market funds$24,302$—$—$24,302
Corporate bonds—27,817—$27,817
Commercial paper—17,797—17,797
U.S. government bonds31,9224,991—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. There wereno transfers of assets between levels during the three months ended June 30, 2026. During thesix months ended June 30, 2026, a total of $6.0 million, 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. During the three and six months ended June 30, 2025, a total of $1.3 million and $7.8 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.

  1. Balance Sheet Components

Cash and Cash Equivalents

Cash and cash equivalents consisted of the following (in thousands):

June 30, 2026December 31, 2025
Cash$2,797$2,309
Commercial paper—11,272
Money market funds47,84724,302
U.S. government bonds—9,989
Total cash and cash equivalents$50,644$47,872

Investments

As of June 30, 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):

Amortized CostGross UnrealizedHolding GainsGross UnrealizedHolding LossesEstimatedFair Value
Corporate bonds$26,721$3$(45)$26,679
U.S. government bonds18,034—(27)18,007
Total investments$44,755$3$(72)$44,686
Amortized CostGross UnrealizedHolding GainsGross UnrealizedHolding LossesEstimatedFair Value
Corporate bonds$27,800$17$—$27,817
Commercial paper6,525——6,525
U.S. government bonds26,90321—26,924
Total investments$61,228$38$—$61,266

The following table summarizes, for all available-for-sale securities in an unrealized loss position as of June 30, 2026, the fair value and gross unrealized loss by length of time the security has been in a continual unrealized loss position (in thousands):

Less than 12 Months12 Months or MoreTotal
EstimatedFair ValueGross UnrealizedHolding LossesEstimatedFair ValueGross UnrealizedHolding LossesEstimatedFair ValueGross UnrealizedHolding Losses
Corporate bonds$22,322$(45)$—$—$22,322$(45)
U.S. government bonds18,007(27)——18,007(27)
Total$40,329$(72)$—$—$40,329$(72)

As of December 31, 2025, all available-for-sale securities in an unrealized loss position had immaterial unrealized losses.

As of June 30, 2026, the available-for-sale investments had remaining contractual maturities withintwo 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 didnot recognize any credit related losses or other impairment loss during thethree and six months ended June 30, 2026 and 2025.

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in thousands):

June 30, 2026December 31, 2025
Holdback consideration receivable related to divestiture$—$4,000
Prepaid assets9431,015
Other current assets8331,121
Total prepaid expenses and other current assets$1,776$6,136

As of December 31, 2025, the Company recorded a $4.0 million receivable in prepaid expenses and other current assets for the holdbacks related to theclosing of the divestiture of FibroGen International. On June 2, 2026, the Company received a $4.0 million payment from AstraZeneca, which is in full satisfaction of the final holdback. See Note 3, Discontinued Operations and Divestiture, for details.

Accrued and Other Current Liabilities

Accrued and other current liabilities consisted of the following (in thousands):

June 30, 2026December 31, 2025
Preclinical and clinical trial accruals$4,716$3,066
API and bulk drug product price true-up5,1946,977
Payroll and related accruals1,9583,983
Accrued restructuring charge211537
Professional services8,8962,465
Current portion of liability related to sale of future revenues2151,334
Other1,9221,821
Total accrued and other current liabilities$23,112$20,183

The accrued liabilities of$5.2 million and $7.0 million for API and bulk drug product price true-up as of June 30, 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, Netsection in Note 4, Collaboration Agreements, License Agreement and Revenues, for details.

  1. 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, andreceived $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 thethree and six months ended June 30, 2025. The Company recorded interest expense of $3.0 million and $5.9 million for thethree and six months ended June 30, 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.

  1. 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, ifthe payment is made on or before December 31, 2028; (b) $112.5 million, ifthe payment is made on or after January 1, 2029, but on or before December 31, 2029; or (c) $125.0 million, ifthe 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 costsand effective interest rate, and adjusts the accounting prospectively as needed. The Company’s estimated effective annual interest rate was 15.16% as of June 30, 2026.

The following table summarizes the activities of the liability related to sale of future revenues for thesix months ended June 30, 2026:

Six Months Ended June 30,
Liability related to sale of future revenues - beginning balance$67,314
Interest paid(1,316)
Interest expense recognized4,712
Liability related to sale of future revenues - ending balance70,710
Less: Current portion classified to accrued and other current liabilities(215)
Liability related to sale of future revenues, non-current$70,495

During the three and six months ended June 30, 2026, the Company recognized, under Astellas Agreements, development revenue of$0.1 million and$0.3 million, respectively, and drug product revenue of$(1.6) million and$1.9 million, respectively. During the three and six months ended June 30, 2025, the Company recognized, under Astellas Agreements, development revenue of $0.1 million and $0.3 million, respectively, and drug product revenue of $1.2 million and $3.8 million, respectively. See Note 4, Collaboration Agreements, License Agreement and Revenue, for details.

During three and six months ended June 30, 2026, the Company recognized the related interest expense of $2.4 million and $4.7 million, respectively. During the three and six months ended June 30, 2025, the Company recognized the related interest expense of $2.0 million and $4.1 million, respectively. During the six months ended June 30, 2026 and 2025, the Company paid $1.3 million and $0.5 million accrued interest, respectively.

  1. Income Taxes

Benefit from income taxes for the three and six months ended June 30, 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.

  1. Commitments and Contingencies

Contract Obligations

As of June 30, 2026, the Company had outstanding total non-cancelable purchase obligations of $5.7 million for manufacture and supply of roxadustat and $1.0 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 Revenuesfor 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. As of June 30, 2026, the Company did not have any material accruals for any active legal actions that it is named in.

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 June 30, 2026, the Company’s accrued liabilities related to these obligations were approximately $7.0 million based on its best estimate. The Company is unable to reasonably estimate the total amount of future indemnification costs beyond amounts currently accrued due to significant uncertainties regarding the duration, scope, and outcome of the proceedings.

  1. Segment Information

The Company hasone operating and reportable segment which primarily focuses on the development and commercialization of novel therapeutics to treat serious unmet medical needs. The Company has determined that thechief 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, gain on deconsolidation of subsidiary, 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.

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