What changed in this filing

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Item 1. Financial Statements

2026-08-05 compared with 2026-05-05 · 108 added, 90 removed, 338 unchanged (37% of the section changed)

7 unchanged sentences

Receivable from collaboration partner

Contract asset

Prepaid expenses and other current assets

4 unchanged sentences

Operating lease right-of-use asset

Other non-current asset

Liabilities and Stockholders’ Equity

12 unchanged sentences

Common stock, $ 0.00001 par value, 180,000,000 shares authorized;

64,227,057 and 62,577,897 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively

64,672,032 and 62,577,897 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively

Additional paid-in capital

8 unchanged sentences

Three Months Ended

Six Months Ended

License and collaboration revenue

3 unchanged sentences

Total operating expenses

Loss from operations

Income (loss) from operations

Interest income

Other income, net

Income (loss) before income tax benefit

Income tax benefit

Other (expense) income, net

Income (loss) before income tax expense

Income tax expense

Net income (loss)

8 unchanged sentences

Three Months Ended

Six Months Ended

Net income (loss)

8 unchanged sentences

Stockholders’

(Loss) income

Three months ended March 31, 2026

Balance at December 31, 2025

Income (Loss)

Three months ended June 30, 2026

Balance at March 31, 2026

Issuance of common stock under equity incentive and employee stock purchase plans

1 unchanged sentence

Other comprehensive loss

Balance at June 30, 2026

Comprehensive

Stockholders’

Income (Loss)

Three months ended June 30, 2025

Balance at March 31, 2025

Issuance of common stock under equity incentive and employee stock purchase plans

Stock-based compensation expense

Other comprehensive loss

Balance at June 30, 2025

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

PROTAGONIST THERAPEUTICS, INC.

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands, except share data)

Comprehensive

Stockholders’

(Loss) income

Three months ended March 31, 2025

Income (Loss)

Six months ended June 30, 2026

Balance at December 31, 2025

Issuance of common stock under equity incentive and employee stock purchase plans

Stock-based compensation expense

Other comprehensive loss

Balance at June 30, 2026

Comprehensive

Stockholders’

Income (Loss)

Six months ended June 30, 2025

Balance at December 31, 2024

Issuance of common stock under equity incentive and employee stock purchase plans

Shares withheld for net settlement of tax withholding upon vesting of restricted stock units

1 unchanged sentence

Other comprehensive income

Balance at March 31, 2025

Balance at June 30, 2025

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

2 unchanged sentences

(In thousands)

Three Months Ended

Six Months Ended

Cash Flows from Operating Activities

Net income (loss)

Adjustments to reconcile net income (loss) to net cash (used in) provided by operating activities:

Adjustments to reconcile net income (loss) to net cash provided by operating activities:

Stock-based compensation

10 unchanged sentences

Operating lease liability

Net cash (used in) provided by operating activities

Other non-current asset

Net cash provided by operating activities

Cash Flows from Investing Activities

18 unchanged sentences

Protagonist Therapeutics, Inc.

(the “Company”) is a discovery through late-stage development biopharmaceutical company with a proprietary peptide technology platform that enables de novo discovery of peptide therapeutics.

(the “Company”) is a discovery through late-stage development biopharmaceutical company with a proprietary technology platform that enables de novo discovery of peptide therapeutics.

The Company’s programs fall into three broad therapeutic areas:

7 unchanged sentences

Rusfertide, a first-in-class investigational injectable mimetic of the natural hormone hepcidin, is currently in development for the treatment of the rare blood disorder polycythemia vera (“PV”).

Rusfertide is being co-developed with Takeda Pharmaceuticals, Inc.

The Company holds an option to co-commercialize rusfertide in the United States through a 50/50 profit and loss share structure with Takeda or can opt out of this structure.

Rusfertide is licensed to Takeda Pharmaceuticals Inc.

The Company discovered and led development for rusfertide through Phase 3, and Takeda is responsible for further development and commercialization.

In August 2025, rusfertide was granted Breakthrough Therapy designation by the U.S.

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In December 2025, a New Drug Application (“NDA”) was submitted to the FDA by Takeda and the Company seeking the first approval of rusfertide for the treatment of adults with PV.

The NDA was granted priority review by the FDA, with a Prescription Drug User Fee Act target action date in the third quarter of 2026.

The NDA was granted priority review by the FDA, with a Prescription Drug User Fee Act target action date in August 2026.

The Company also has a number of clinical and pre-clinical programs addressing biologically and commercially validated targets, including IL-17 oral peptide antagonist PN-881, obesity triple agonist peptide PN-477, obesity dual agonist peptide PN-458, oral small molecule hepcidin functional mimetic PN-8047, and IL-4 and amylin programs.

3 unchanged sentences

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”), the instructions to Form 10-Q and Rule 10-01 of Regulation S-X and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting.

As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted and, accordingly, the condensed consolidated balance sheet as of March 31, 2026 has been derived from the Company’s unaudited consolidated financial statements at that date but does not include all of the information required by GAAP for complete consolidated financial statements.

As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted and, accordingly, the condensed consolidated balance sheet as of June 30, 2026 has been derived from the Company’s unaudited consolidated financial statements at that date but does not include all of the information required by GAAP for complete consolidated financial statements.

These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments (consisting of normal recurring adjustments) that are necessary for a fair presentation of the Company’s condensed consolidated financial statements.

The results of operations for the three months ended March 31, 2026 are not necessarily indicative of the results to be expected for the year ending December 31, 2026 or for any future period.

The results of operations for the three and six months ended June 30, 2026 are not necessarily indicative of the results to be expected for the year ending December 31, 2026 or for any future period.

The accompanying unaudited condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2025 included in the Company’s Annual Report on Form 10-K, filed with the SEC on February 25, 2026.

19 unchanged sentences

Total cash reported on condensed consolidated statements of cash flows

Restricted cash as of March 31, 2026 consists of (i) a $ 225 thousand cash deposit held as security in connection with a letter of credit related to the Company’s facility lease entered into in March 2017, as subsequently amended, and (ii) a $ 63 thousand cash deposit held as security in connection with the issuance of a bank guarantee in May 2025 to maintain the active status of the Company’s value-added tax registration.

Restricted cash as of June 30, 2026 and 2025 consists of a cash deposit held as security in connection with a letter of credit related to the Company’s facility lease entered into in March 2017, as subsequently amended, and a cash deposit held as security in connection with the issuance of a bank guarantee in May 2025 to maintain the active status of the Company’s value-added tax registration.

Stock-Based Compensation Expense

8 unchanged sentences

The cumulative effect on current and prior periods of a change in the estimated number of PSUs expected to be earned is recognized as compensation expense or as reduction of previously recognized compensation expense in the period of the revised estimate.

No stock-based compensation related to PSUs was recognized for the three months ended March 31, 2026.

The Company recognized $ 1.8 million of stock-based compensation expense related to PSUs for the three months ended March 31, 2025.

No stock-based compensation related to PSUs was recognized for the three and six months ended June 30, 2026 and the three months ended June 30, 2025.

The Company recognized $ 1.8 million of stock-based compensation expense related to PSUs for the six months ended June 30, 2025.

The Company recognizes forfeitures of stock-based awards as they occur.

1 unchanged sentence

Three Months Ended

Six Months Ended

Research and development

2 unchanged sentences

Significant Accounting Policies

There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2026, as compared to those disclosed in Note 2.

There have been no material changes to the Company’s significant accounting policies during the three and six months ended June 30, 2026, as compared to those disclosed in Note 2.

Summary of Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.

Recently Issued Accounting Pronouncements Not Yet Adopted as of March 31, 2026

Recently Issued Accounting Pronouncements Not Yet Adopted as of June 30, 2026

In December 2025, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No.

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Under the JNJ License and Collaboration Agreement, JNJ is required to use commercially reasonable efforts to develop at least one collaboration compound for at least two indications.

During the first quarter of 2026, the Company earned a $ 50.0 million milestone payment upon FDA approval of ICOTYDE for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients over 12 years of age or older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy.

The Company has earned a total of $ 387.5 million in non-refundable payments from JNJ under the JNJ License and Collaboration Agreement from inception in 2017 through March 31, 2026.

During the first quarter of 2026, the Company earned a $ 50.0 million milestone payment upon FDA approval of ICOTYDE for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age or older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy.

The Company has earned a total of $ 387.5 million in non-refundable upfront and milestone payments from JNJ under the JNJ License and Collaboration Agreement from inception in 2017 through June 30, 2026.

Upcoming potential development milestones under the JNJ License and Collaboration Agreement include:

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In January 2024, the Company entered into a worldwide license and collaboration agreement for rusfertide with Takeda, which became effective in March 2024, and was amended in March 2025 (the “Takeda Collaboration Agreement”).

Pursuant to the Takeda Collaboration Agreement, the Company and Takeda are jointly developing and commercializing rusfertide and potentially other specified second-generation injectable hepcidin mimetic compounds (the “Licensed Products”) in the United States (the “Profit-Share Territory”).

Takeda is solely and exclusively responsible for the development and commercialization of the Licensed Products in all other countries (the “Takeda Territory”).

The Company and Takeda share the costs of the development, manufacture and commercialization activities for the Licensed Products in the Profit-Share Territory, provided that (i) the Company leads, and is solely responsible for its costs associated with, completion of the ongoing Phase 3 VERIFY trial evaluating rusfertide for the treatment of PV;

(ii) Takeda leads, and is solely responsible for its costs associated with, U.S.

Pursuant to the Takeda Collaboration Agreement, the Company and Takeda agreed to jointly develop and commercialize rusfertide and potentially other specified second-generation injectable hepcidin mimetic compounds (the “Licensed Products”) in the United States (the “Profit-Share Territory”).

Takeda was solely and exclusively responsible for the development and commercialization of the Licensed Products in all other countries (the “Takeda Territory”).

The Company and Takeda shared the costs of the development, manufacture and commercialization activities for the Licensed Products in the Profit-Share Territory, provided that (i) the Company led, and was solely responsible for its costs associated with, completion of the ongoing Phase 3 VERIFY trial evaluating rusfertide for the treatment of PV;

(ii) Takeda led, and was solely responsible for its costs associated with, U.S.

regulatory and pre-commercialization activities related to rusfertide in the Profit-Share Territory;

and (iii) Takeda leads commercialization of rusfertide in the Profit-Share Territory, with the Company holding an option to co-detail.

Takeda is solely responsible for all costs for the development, manufacture and commercialization of the Licensed Products in the Takeda Territory.

and (iii) Takeda led commercialization of rusfertide in the Profit-Share Territory, though the Company held an option to co-detail.

Takeda was solely responsible for all costs for the development, manufacture and commercialization of the Licensed Products in the Takeda Territory.

The Company granted Takeda a non-transferable, sublicensable and, except for certain specified exceptions, exclusive license to certain intellectual property of the Company to exercise its rights and perform its obligations under the Takeda Collaboration Agreement.

In March 2025, the Company and Takeda agreed, pursuant to the provisions of the Takeda Collaboration Agreement, as amended, that Takeda would assume responsibility for leading and implementing the regulatory strategy and associated activities for preparation of the NDA related to rusfertide in PV, which was submitted to the FDA in December 2025.

The Company was primarily responsible for clinical development activities through the NDA filing and remains responsible for conducting ongoing rusfertide long-term extension studies.

The Company received a one-time, non-refundable upfront payment of $ 300.0 million in April 2024 and a $25.0 million milestone payment in September 2025.

In addition, the Company is eligible to receive additional worldwide development, regulatory and commercial milestone payments for rusfertide of up to $ 305.0 million, and tiered royalties from 10 % to 17 % on net sales of the Licensed Products in the Takeda Territory.

The Company and Takeda will also share equally in profits and losses ( 50 % to the Company and 50 % to Takeda) for Licensed Products in the Profit-Share Territory.

Takeda will book sales of the Licensed Products globally.

The Company has the right to opt-out entirely of profit- and loss-sharing in the Profit-Share Territory for rusfertide and all other Licensed Products (the “Full Opt-out Right”) (i) during the 90-day period beginning 120 days after the filing of an NDA with the FDA for rusfertide for PV (the “Initial Opt-out Period”);

and (ii) for convenience without receipt of the Opt-out Payment (as defined below) (generally following the Initial Opt-out Period).

In addition, if the Company does not exercise the Full Opt-out Right, the Company may opt-out of any Licensed Product other than rusfertide on a Licensed Product-by-Licensed Product basis (each, a “Partial Opt-out Right” and either the Full Opt-out Right or a Partial Opt-out right being an “Opt-out Right”).

Following the Company’s exercise of an Opt-out Right, the Company has agreed to transition applicable development and commercial activities to Takeda, and Takeda has agreed to assume sole operational and financial responsibility for such activities in the United States.

The Takeda Collaboration Agreement provides for aggregate development, regulatory and commercial milestone payments from Takeda to the Company for rusfertide of up to $ 975.0 million if the Company exercises the Full Opt-out Right.

In addition to these milestone payments, in the event the Company exercises the Full Opt-out Right during the Initial Opt-out Period, the Company will receive:

(i) a $ 200.0 million payment following its exercise of the

Full Opt-out Right;

and (ii) an additional $ 200.0 million payment following FDA approval of the NDA for rusfertide for PV (together, the “Opt-out Payment”).

If the Company exercises an Opt-out Right, Takeda has agreed to pay the Company royalties of 14 % to 29 % on worldwide net sales of the Licensed Products with respect to which the Company has exercised an Opt-out Right.

In addition, the Company will also be eligible to receive sales milestones of up to $ 775.0 million, should the Company exercise its Opt-out Right.

The Company was primarily responsible for clinical development activities through the NDA filing and for conducting ongoing rusfertide long-term extension studies.

Pursuant to the Takeda Collaboration Agreement, the Company received a one-time, non-refundable upfront payment of $ 300.0 million in April 2024 and a $ 25.0 million milestone payment in September 2025.

On April 28, 2026, the Company announced that it exercised its right to opt out of the U.S.

profit and loss sharing arrangement ( 50 % to the Company and 50 % to Takeda) under the Takeda Collaboration Agreement.

Following the Company’s exercise of the opt-out right, the Company has agreed to transition applicable development and commercial activities to Takeda, and Takeda has the right to assume sole operational and financial responsibility for such activities in the United States.

The opt-out election triggered a $ 200.0 million payment, with an additional $ 200.0 million opt-out fee and a separate $ 75.0 million milestone due upon FDA approval of rusfertide.

Following the opt-out, the Company is also eligible to receive up to $ 775.0 million in sales milestone payments and tiered royalties ranging from 14 % to 29 % on annual net worldwide sales, with an approximate 21 % weighted-average royalty rate at $ 1.5 billion in annual net sales and a 29 % tier applying to incremental annual net sales above $ 1.5 billion.

Upcoming potential development milestones under the Takeda Collaboration Agreement include:

● $ 50.0 million upon FDA approval of an NDA for rusfertide in PV (or $ 75.0 million if the Company exercises the Full Opt-out Right);

● $ 75.0 million upon FDA approval of an NDA for rusfertide in PV;

● $ 15.0 million upon first regulatory approval for rusfertide in PV in three European countries, after pricing and reimbursement approval;

● $ 10.0 million upon first regulatory approval for rusfertide in PV in Japan.

The Company evaluated the Takeda Collaboration Agreement and concluded that it has elements that are within the scope of ASC Topic 606 and ASC Topic 808.

The Company is obligated to perform certain wind-down activities during the three-month opt-out wind-down period which includes transferring the VERIFY trial and other projects to Takeda, overseeing vendors and development activities until such activities are fully transferred to Takeda, and continuing to perform the rusfertide open label extension.

Such costs during the wind-down period (from April 28, 2026 to July 27, 2026) are shared ( 50 %) with Takeda and the Company aims to transfer the majority of the activities to Takeda by July 27, 2026.

As agreed upon with Takeda, Protagonist will continue work for the rusfertide open-label extension after the wind-down period until completion, which is expected in the first quarter of 2027.

Costs incurred by Protagonist for any remaining wind-down activities and rusfertide open-label extension after July 27, 2026 will be fully reimbursed by Takeda.

The Company initially evaluated the Takeda Collaboration Agreement and concluded that it had elements that were within the scope of ASC Topic 606 and ASC Topic 808.

As of the effective date of the Takeda Collaboration Agreement, the Company identified two distinct performance obligations:

(i) the rusfertide license delivered upon the effectiveness of the Takeda Collaboration Agreement and (ii) certain development services to be provided prior to the Initial Opt-out Period, including certain of the Company’s responsibilities to complete the VERIFY Phase 3 clinical trial in PV and associated manufacturing services.

(i) the rusfertide license delivered upon the effectiveness of the Takeda Collaboration Agreement and (ii) certain development services to be provided prior to the opt-out period, including certain of the Company’s responsibilities to complete the VERIFY Phase 3 clinical trial in PV and associated manufacturing services.

Following the completion of the wind-down period on July 27, 2026, the Takeda Collaboration Agreement will no longer meet the definition of a collaborative arrangement under ASC Topic 808.

The Company determined that the initial transaction price totaled $ 300.0 million, which was comprised of the upfront payment.

7 unchanged sentences

The amount allocated to development services will be recognized over time based on a measure of the Company’s efforts toward satisfying the performance obligation relative to the total expected efforts or inputs to satisfy the performance obligation (e.g., costs incurred compared to total budget).

As of the opt-out date, the development services performance obligation remained partially unsatisfied.

The exercise of the opt-out right results in a contract modification under ASC Topic 606 because it changes the enforceable rights and obligations of the parties under the Takeda Collaboration Agreement.

As a result, the remaining unconstrained consideration was allocated to the remaining development services performance obligation, and the modification was accounted for as part of the existing contract.

Revenue Recognition

For the three months ended March 31, 2026, the Company recognized license and collaboration revenue of $ 56.4 million including (i) a $ 50.0 million milestone payment related to the JNJ License and Collaboration Agreement, which was earned upon FDA approval of ICOTYDE for the treatment of moderate-to-severe plaque psoriasis in March 2026, (ii) $ 3.3 million related to the Takeda Collaboration Agreement for development services provided by the Company during the period using the cost-based input method, and (iii) $ 3.1 million from Takeda for rusfertide clinical supplies.

The remaining $ 6.3 million in deferred revenue as of March 31, 2026 will be recognized through the conclusion of the development services performance obligation.

For the three months ended March 31, 2025, the Company recognized license and collaboration revenue of $ 28.3 million related to the Takeda Collaboration Agreement, including (i) $ 22.8 million related to the proportional recognition of the $ 25.0 milestone deemed probable of being achieved due to the Phase 3 VERIFY trial meeting its primary endpoint and (ii) $ 5.5 million related to the initial transaction price for development services provided by the Company during the period.

Revenue recognition for the $ 25.0 million milestone, which was payable upon completion of the VERIFY clinical study report, was allocated based on the initial standalone selling price of each performance obligation under the agreement.

The remaining $ 2.2 million in revenue related to the milestone is recognized through the conclusion of the development services performance obligation.

The Company recorded a corresponding contract asset of $ 22.8 million on its condensed consolidated balance sheet as of March 31, 2025.

For the three months ended March 31, 2026, the Company recognized $ 3.3 million of revenue that was included in the deferred revenue balance at the beginning of the period.

For the three months ended March 31, 2025, the Company recognized $ 5.5 million of revenue that was included in the deferred revenue balance at the beginning of the period.

For the three months ended June 30, 2026, the Company recognized license and collaboration revenue of $ 213.5 million.

This included $202.5 million under the Takeda Collaboration Agreement using the cost-based input method for development services, consisting of (i) $ 192.4 million related to the proportional recognition of the $ 200.0 million opt-out payment, (ii) $ 5.7 million related to cost reimbursement for post opt-out wind-down services provided by the Company, $ 3.4 million of which was recorded as a contract asset, and (iii) $ 4.4 million related to the initial upfront payment and milestones received to date.

In addition, the Company recognized revenue during the period of $ 11.0 million for rusfertide clinical supplies under the Takeda Collaboration Agreement and other revenues.

The remaining $ 7.6 million in revenue related to the $ 200.0 million opt-out payment under the Takeda Collaboration Agreement was recorded as deferred revenue on the Company’s condensed consolidated balance sheet and is expected to be recognized through the conclusion of the development services performance obligation.

For the six months ended June 30, 2026, the Company recognized license and collaboration revenue of $269.8 million.

This included $ 205.7 million under the Takeda Collaboration Agreement using the cost-based input method for development services, consisting of (i) $ 192.4 million related to the proportional recognition of the $ 200.0 million opt-out payment, (ii) $ 5.7 million related to cost reimbursement for post opt-out wind-down services provided by the Company, $3.4 million of which was recorded as a contract asset, and (iii) $ 7.6 million related to the initial upfront payment and milestones received to date.

In addition, the Company recognized a $ 50.0 million milestone payment related to the JNJ License and Collaboration Agreement, which was earned upon FDA approval of ICOTYDE for the treatment of moderate-to-severe plaque psoriasis, and $14.1 million for rusfertide clinical supplies under the Takeda Collaboration Agreement and other revenues.

For the three and six months ended June 30, 2026, the Company recognized $ 4.4 million and $ 7.6 million of revenue, respectively, that was included in the deferred revenue balance at the beginning of the period.

None of the costs to obtain or fulfill the contracts were capitalized.

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The following tables present the fair value of the Company’s financial assets determined using the inputs defined above (in thousands):

March 31, 2026

June 30, 2026

Money market funds

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

March 31, 2026

June 30, 2026

Gross Unrealized

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All of the Company’s marketable securities are classified as available-for-sale.

Current marketable securities of $ 354.1 million and $ 439.0 million held as of March 31, 2026 and December 31, 2025, respectively, had contractual maturities of less than one year .

Noncurrent marketable securities of $ 72.5 million and $ 78.6 million held as of March 31, 2026 and December 31, 2025, respectively, had contractual maturities of at least one year but no more than two years .

Current marketable securities of $ 362.5 million and $ 439.0 million held as of June 30, 2026 and December 31, 2025, respectively, had contractual maturities of less than one year .

Noncurrent marketable securities of $ 66.9 million and $ 78.6 million held as of June 30, 2026 and December 31, 2025, respectively, had contractual maturities of at least one year but no more than two years .

The Company does not intend to sell its securities that are in an unrealized loss position, and it is not more likely than not that the Company will be required to sell its securities before recovery of their amortized cost basis, which may be at maturity.

The Company sold $ 3.4 million and $ 7.0 million of marketable securities and realized a net gain of $ 2.0 thousand and a net loss of $ 5.0 thousand during the three months ended March 31, 2026 and 2025, respectively.

The Company evaluated securities with unrealized losses to determine whether such losses, if any, were due to credit-related factors and determined that there were no credit-related losses to be recognized as of March 31, 2026 and December 31, 2025.

During the six months ended June 30, 2026 and 2025, the Company sold $ 3.4 million and $ 7.0 million of marketable securities and realized a net gain of $ 5.0 thousand and a net loss of $ 5.0 thousand, respectively.

Balance Sheet Components

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Prepaid clinical and research related expenses

Prepaid insurance

Prepaid licenses

Prepaid insurance

Prepaid expenses and other current assets

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Pre-Funded Warrants

In August 2018, the Company entered into a Securities Purchase Agreement with certain accredited investors (each, an “Investor” and, collectively, the “Investors”).

In a concurrent private placement, the Company issued the Investors warrants to purchase an aggregate of 2,750,000 shares of its common stock (each, a “Warrant” and, collectively, the “Warrants”).

Each Warrant was exercisable from August 8, 2018 through August 8, 2023 .

In August 2023, prior to the expiration of the Warrants, the Company entered into certain agreements with the Investors and their affiliates under which the Company agreed to allow the Warrants to be exercised in exchange for pre-funded warrants representing the same number of Warrant Shares underlying the Warrants with an exercise price of $ 0.001 per share (the “Pre-Funded Warrants”).

Subsequent to the execution of the agreements and prior to the expiration of the Warrants in August 2023, all outstanding Warrants were exercised for gross proceeds of $ 34.4 million in exchange for 44,748 shares of the Company’s common stock and Pre-Funded Warrants to purchase 2,705,252 shares of common stock (subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Pre-Funded Warrants) with an exercise price of $ 0.001 per share.

In August 2023, the Company entered into certain agreements with certain accredited investors and their affiliates (the “Investors”) under which the Company issued pre-funded warrants with an exercise price of $ 0.001 per share (the “Pre-Funded Warrants”).

The Pre-Funded Warrants will expire on the day they are exercised in full.

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In accordance with ASC Topic 260, “ Earnings Per Share” , outstanding Pre-Funded Warrants are included in the computation of basic net income (loss) per share because the exercise price is negligible, and they are fully vested and exercisable after the original issuance date.

No Pre-Funded Warrants were exercised during the three months ended March 31, 2026 and 2025.

As of March 31, 2026, Pre-Funded Warrants to purchase 1,500,000 shares of common stock remained outstanding.

The Company recorded income tax benefit of $ 1.5 million for the three months ended March 31, 2026.

No income tax expense or benefit was recorded by the Company for the three months ended March 31, 2025.

The tax provision for the three months ended March 31, 2026 was determined using an estimated annual effective tax rate, adjusted for discrete items, if any.

The income tax benefit for the three months ended March 31, 2026 included a discrete item for stock-based compensation expense.

No Pre-Funded Warrants were exercised during the three and six months ended June 30, 2026 and 2025.

As of June 30, 2026, Pre-Funded Warrants to purchase 1,500,000 shares of common stock remained outstanding.

The Company recorded income tax expense of $ 2.3 million and $ 0.8 million for the three and six months ended June 30, 2026, respectively.

The Company recorded income tax expense of $ 0.2 million for both the three and six months ended June 30, 2025.

The increases in income tax expense were due to pretax income recorded as compared to pretax losses for the prior year periods.

The tax provision for the three and six months ended June 30, 2026 was determined using an estimated annual effective tax rate, adjusted for discrete items, if any.

Net Income (Loss) per Share

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Three Months Ended

Six Months Ended

Net income (loss)

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Diluted net income (loss) per share of common stock

Approximately 0.2 million potentially dilutive shares of common stock (consisting of shares subject to outstanding stock options, RSUs, PSUs and under the ESPP, as applicable) were excluded from the diluted net income per share of common stock computation for the three months ended March 31, 2026 because their effect was anti-dilutive.

Approximately 9.7 million potentially dilutive shares of common stock (consisting of shares subject to outstanding stock options, RSUs, PSUs, and under the ESPP, as applicable) were excluded from the diluted net loss per share of common stock computation for the three months ended March 31, 2025 due to the Company’s net loss for the period.

Approximately 0.9 million potentially dilutive shares of common stock (consisting of shares subject to outstanding stock options, RSUs, PSUs and under the ESPP, as applicable) were excluded from the diluted net income per share of common stock computation for the three and six months ended June 30, 2026 because their effect was anti-dilutive.

Approximately 9.5 million potentially dilutive shares of common stock (consisting of shares subject to outstanding stock options, RSUs, PSUs, and under the ESPP, as applicable) were excluded from the diluted net loss per share of common stock computation for the three and six months ended June 30, 2025 due to the Company’s net loss for these periods.

Segment Reporting

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The Company’s Chief Executive Officer serves as the Company’s CODM and manages and allocates resources to the operations of the Company on an entity-wide basis.

Managing and allocating resources on an entity-wide basis enables the CODM to assess the overall level of resources available and how to best deploy these resources across functions and research and development projects based on unmet medical need, scientific data, probability of technical and regulatory successful development, market potential and other considerations, and, as necessary, reallocate resources among our internal research and development portfolio and external opportunities to best support the long-term growth of our business.

Managing and allocating resources on an entity-wide basis enables the CODM to assess the overall level of resources available and how to best deploy these resources across functions and research and development projects based on unmet medical need, scientific data, probability of technical and regulatory successful development, market potential and other considerations, and, as necessary, reallocate resources among the Company’s internal research and development portfolio and external opportunities to best support the long-term growth of the Company’s business.

The Company’s CODM reviews financial information on an aggregate basis for the purpose of allocating resources and evaluating financial performance, including segment net income (loss), which is also reported on the condensed consolidated statement of operations as consolidated net income (loss).

1 unchanged sentence

Three Months Ended

Six Months Ended

License and collaboration revenue

Discovery department expense (1)(2)

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Interest income

Income tax benefit

Segment profit (loss)

Reconciliation of profit (loss)

Adjustments and reconciling items

Income tax expense

Consolidated net income (loss)

6 unchanged sentences

The measure of segment assets is reported as total assets on the Company’s condensed consolidated balance sheets for the periods presented.

Subsequent Events

On April 28, 2026, the Company announced that it exercised its right to opt out of the U.S.

profit and loss sharing arrangement ( 50 % to the Company and 50 % to Takeda) under the Takeda Collaboration Agreement.

The opt-out election triggered a $ 200.0 million payment, with an additional $ 200.0 million opt-out fee and a separate $ 75.0 million milestone upon FDA approval of rusfertide.

Following the opt-out, the Company is also eligible to receive up to $ 775 .0 million in sales milestone payments and tiered royalties ranging from 14 % to 29 % on annual net worldwide sales, with an approximate 21 % weighted-average royalty rate at $ 1.5 billion in annual net sales and a 29 % tier applying to incremental annual net sales above $ 1.5 billion.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements