What changed in this filing

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Item 1. Financial Statements

2025-07-31 compared with 2025-05-01 · 101 added, 78 removed, 371 unchanged (33% of the section changed)

29 unchanged sentences

25,000,000 shares authorized;

no shares issued or outstanding at March 31, 2025 and December 31, 2024

no shares issued or outstanding at June 30, 2025 and December 31, 2024

Common stock, $ 0.001 par value;

125,000,000 shares authorized;

74,103,192 shares issued and 57,886,781 shares outstanding at March 31, 2025, and 73,372,696 shares issued and 57,156,285 shares outstanding at December 31, 2024

74,254,956 shares issued and 58,038,545 shares outstanding at June 30, 2025, and 73,372,696 shares issued and 57,156,285 shares outstanding at December 31, 2024

Additional paid-in capital 2,521,545 2,493,811

Accumulated other comprehensive income (loss) 655 ( 1,518 )

Treasury stock, at cost ( 16,216,411 shares at March 31, 2025 and December 31, 2024)

Treasury stock, at cost ( 16,216,411 shares at June 30, 2025 and December 31, 2024)

( 802,486 ) ( 802,486 )

5 unchanged sentences

Condensed Consolidated Statements of Operations

Three Months Ended March 31,

Three Months Ended June 30, Six Months Ended June 30,

(In thousands, except share and per share data)

2025 2024 2025 2024

Product revenue, net $ 12,455 $ 8,615 $ 21,181 $ 16,804

14 unchanged sentences

Condensed Consolidated Statements of Comprehensive Loss

Three Months Ended March 31,

Three Months Ended June 30, Six Months Ended June 30,

(In thousands)

2025 2024 2025 2024

Net loss $ ( 112,020 ) $ ( 96,118 ) $ ( 201,309 ) $ ( 177,667 )

7 unchanged sentences

Capital Accumulated

Comprehensive

Comprehensive Income

(Loss) Accumulated

8 unchanged sentences

Balance at March 31, 2025 74,103,192 $ 74 $ 2,506,788 $ 365 $ ( 238,213 ) ( 16,216,411 ) $ ( 802,486 ) $ 1,466,528

Unrealized gain on available-for-sale securities — — — 290 — — — 290

Common stock issued under stock incentive plan and ESPP 151,764 — 65 — — — — 65

Stock-based compensation expense — — 14,692 — — — — 14,692

Net loss — — — — ( 112,020 ) — — ( 112,020 )

Balance at June 30, 2025 74,254,956 $ 74 $ 2,521,545 $ 655 $ ( 350,233 ) ( 16,216,411 ) $ ( 802,486 ) $ 1,369,555

Common Stock Additional

11 unchanged sentences

Balance at March 31, 2024 72,967,922 $ 73 $ 2,451,620 $ ( 1,087 ) $ ( 904,198 ) ( 16,216,411 ) $ ( 802,486 ) $ 743,922

Unrealized gain on available-for-sale securities — — — 42 — — — 42

Common stock issued under stock incentive plan and ESPP 123,568 — 1,099 — — — — 1,099

Stock-based compensation expense — — 11,565 — — — — 11,565

Net loss — — — — ( 96,118 ) — — ( 96,118 )

Balance at June 30, 2024 73,091,490 $ 73 $ 2,464,284 $ ( 1,045 ) $ ( 1,000,316 ) ( 16,216,411 ) $ ( 802,486 ) $ 660,510

See accompanying Notes to Condensed Consolidated Financial Statements.

1 unchanged sentence

Condensed Consolidated Statements of Cash Flows

Three Months Ended

Six Months Ended

(In thousands) 2025 2024

5 unchanged sentences

Net accretion of discount on marketable securities ( 3,768 ) ( 5,136 )

Gain on disposal of property and equipment — ( 39 )

Loss (gain) on disposal of property and equipment 5 ( 39 )

Non-cash operating lease expense 6,094 5,659

Expense associated with license agreement 10,000 —

Realized gain on investments ( 2 ) ( 153 )

7 unchanged sentences

Operating lease liabilities ( 8,228 ) ( 7,376 )

Other non-current liabilities ( 779 ) —

Net cash used in operating activities ( 188,613 ) ( 172,456 )

2 unchanged sentences

Proceeds from maturities and sales of marketable securities 508,894 510,669

Payments associated with license agreement ( 10,000 ) —

Purchases of property and equipment ( 1,641 ) ( 299 )

8 unchanged sentences

Supplemental disclosure of non-cash investing and financing transactions

Additions to property and equipment in accounts payable and accrued expenses $ 221 $ —

Net cash taxes (returned) paid $ 188 $ ( 525 )

Additions to property and equipment in accounts payable $ 122 $ 42

Net cash taxes paid (returned) $ 1,503 $ ( 603 )

See accompanying Notes to Condensed Consolidated Financial Statements.

16 unchanged sentences

Also in December 2024, we announced that we submitted a marketing authorization application, or MAA, to the European Medicines Agency, or EMA, and regulatory applications to the Kingdom of Saudi Arabia and United Arab Emirates health authorities for PYRUKYND® for the treatment of adult patients with non-transfusion dependent and transfusion-dependent alpha- or beta-thalassemia.

In addition, we are currently evaluating PYRUKYND® in a phase 3 clinical trial for the treatment of sickle cell disease, or SCD.

In addition, we are currently evaluating PYRUKYND® for the treatment of sickle cell disease, or SCD.

We are also developing (i) tebapivat, a novel PK activator, for the potential treatment of lower-risk myelodysplastic syndromes, or LR MDS, and SCD;

2 unchanged sentences

We are subject to risks common to companies in our industry including, but not limited to, uncertainties relating to conducting preclinical and clinical research and development, the manufacture and supply of products for clinical and commercial use, obtaining and maintaining regulatory approvals and pricing and reimbursement for our products, market acceptance, managing global growth and operating expenses, availability of additional capital, competition, obtaining and enforcing patents, stock price volatility, dependence on collaborative relationships and third-party service providers, dependence on key personnel, potential litigation, potential product liability claims and potential government investigations.

Alnylam License Agreement

On July 28, 2023, we entered into a license agreement with Alnylam under which we acquired the rights to develop and commercialize Alnylam’s novel preclinical siRNA targeting the TMPRSS6 gene, as a potential disease-modifying treatment for patients with PV.

In accordance with the license agreement, we are responsible to pay up to $ 130.0 million in potential development and regulatory milestones, in addition to sales milestones as well as tiered royalties on annual net sales, if any, of licensed products, which may be subject to specified reductions and offsets.

In the three months ended June 30, 2025, we achieved a regulatory milestone that triggered a $ 10.0 million payment to Alnylam, which we recorded within research and development expenses in our condensed consolidated statements of operations.

Sale of Oncology Business to Servier and Sale of Contingent Payments

On March 31, 2021, we completed the sale of our oncology business to Servier Pharmaceuticals, LLC, or Servier, which represented a discontinued operation.

The transaction included the sale of our oncology business, including TIBSOVO®, our clinical-stage product candidates vorasidenib, AG-270 and AG-636, and our oncology research programs, for a payment of approximately $ 1.8 billion in cash at the closing, subject to certain adjustments, and a payment of $ 200.0 million in cash, if, prior to January 1, 2027, vorasidenib is granted new drug application approval from the FDA with an approved label that permits vorasidenib’s use as a single agent for the adjuvant treatment of patients with Grade 2 glioma that have an isocitrate dehydrogenase, or IDH, 1 or 2 mutation (and, to the extent required by such approval, the vorasidenib companion diagnostic test is granted an FDA premarket approval), or the Vorasidenib Milestone Payment, as well as a royalty of 5 % of U.S.

The transaction included the sale of our oncology business, including TIBSOVO®, our clinical-stage product candidates vorasidenib, AG-270 and AG-636, and our oncology research programs, for a payment of approximately $ 1.8 billion in cash at the closing, subject to certain adjustments, and a payment of $ 200.0 million in cash, if, prior to January 1, 2027, vorasidenib is granted new drug application, or NDA, approval from the FDA with an approved label that permits vorasidenib’s use as a single agent for the adjuvant treatment of patients with Grade 2 glioma that have an isocitrate dehydrogenase, or IDH, 1 or 2 mutation (and, to the extent required by such approval, the vorasidenib companion diagnostic test is granted an FDA premarket approval), or the Vorasidenib Milestone Payment, as well as a royalty of 5 % of U.S.

net sales of TIBSOVO® from the close of the transaction through loss of exclusivity, and a royalty of 15 % of U.S.

1 unchanged sentence

The Vorasidenib Milestone Payment, Vorasidenib Royalty Rights and royalty payments related to TIBSOVO® are referred to as contingent payments and recognized as income when realizable.

Servier also acquired our co-commercialization rights for

Bristol Myers Squibb’s IDHIFA® and the right to receive a $ 25.0 million potential milestone payment under our prior collaboration agreement with Celgene Corporation, or Celgene, and following the sale Servier has agreed to conduct certain clinical development activities within the IDHIFA® development program.

Servier also acquired our co-commercialization rights for Bristol Myers Squibb’s IDHIFA® and the right to receive a $ 25.0 million potential milestone payment under our prior collaboration agreement with Celgene Corporation, or Celgene, and following the sale Servier has agreed to conduct certain clinical development activities within the IDHIFA® development program.

In October 2022, we sold our rights to future contingent payments associated with the royalty of 5 % of U.S.

11 unchanged sentences

Basis of Presentation

The condensed consolidated balance sheet as of March 31, 2025, the condensed consolidated statements of operations, comprehensive income (loss) and stockholders' equity for the three months ended March 31, 2025 and 2024, and the condensed consolidated statements of cash flows for the three months ended March 31, 2025 and 2024 are unaudited.

The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of our management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state our financial position as of March 31, 2025, our results of operations and stockholders' equity for the three months ended March 31, 2025 and 2024, and cash flows for the three months ended March 31, 2025 and 2024.

The financial data and the other financial information disclosed in these notes to the condensed consolidated financial statements related to the three-month periods are also unaudited.

The results of operations for the three months ended March 31, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025 or for any other future annual or interim period.

The condensed consolidated balance sheet as of June 30, 2025, the condensed consolidated statements of operations, comprehensive loss and stockholders' equity for the three and six months ended June 30, 2025 and 2024, and the condensed consolidated statements of cash flows for the six months ended June 30, 2025 and 2024 are unaudited.

The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of our management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state our financial position as of June 30, 2025, our results of operations and stockholders' equity for the three and six months ended June 30, 2025 and 2024, and cash flows for the six months ended June 30, 2025 and 2024.

The financial data and the other financial information disclosed in these notes to the condensed consolidated financial statements related to the three and six-month periods are also unaudited.

The results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025 or for any other future annual or interim period.

The condensed consolidated balance sheet data as of December 31, 2024 was derived from our audited financial statements, but does not include all disclosures required by U.S.

8 unchanged sentences

We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenues and expenses.

As of March 31, 2025, we had cash, cash equivalents and marketable securities of $ 1.4 billion.

As of June 30, 2025, we had cash, cash equivalents and marketable securities of $ 1.3 billion.

Although we have incurred recurring losses and expect to continue to incur losses for the foreseeable future, we expect our cash, cash equivalents and marketable securities to be sufficient to fund current operations for at least the next twelve months from the issuance of the financial statements.

11 unchanged sentences

Level 3 – Unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date.

The following table summarizes our cash equivalents and marketable securities measured at fair value and by level on a recurring basis as of March 31, 2025:

The following table summarizes our cash equivalents and marketable securities measured at fair value and by level on a recurring basis as of June 30, 2025:

(In thousands) Level 1 Level 2 Level 3 Total

10 unchanged sentences

The pricing services utilize industry standard valuation models, including both income and market-based approaches, and observable market inputs to determine value.

After completing our validation procedures, we did not adjust or override any fair value measurements provided by the pricing services as of March 31, 2025.

There have been no changes to the valuation methods during the three months ended March 31, 2025, and we had no financial assets or liabilities that were classified as Level 3 at any point during the three months ended March 31, 2025.

After completing our validation procedures, we did not adjust or override any fair value measurements provided by the pricing services as of June 30, 2025.

There have been no changes to the valuation methods during the six months ended June 30, 2025, and we had no financial assets or liabilities that were classified as Level 3 at any point during the six months ended June 30, 2025.

Marketable Securities

Our marketable securities are classified as available-for-sale pursuant to ASC 320, Investments – Debt and Equity Securities , and are recorded at fair value.

comprehensive income (loss) in the condensed consolidated statements of comprehensive loss, until realized.

Unrealized gains and losses are included as a component of accumulated other comprehensive income (loss) in the condensed consolidated balance sheets and statements of stockholders’ equity, and a component of total comprehensive income (loss) in the condensed consolidated statements of comprehensive loss, until realized.

Unrealized losses are evaluated for impairment under ASC 326, Financial Instruments - Credit Losses , to determine if the impairment is credit-related or noncredit-related.

1 unchanged sentence

Realized gains and losses are included in investment income on a specific-identification basis.

There were no material realized gains or losses on marketable securities for the three months ended March 31, 2025 or 2024.

Marketable securities at March 31, 2025 consisted of the following:

There were no material realized gains or losses on marketable securities for the three and six months ended June 30, 2025 or 2024.

Marketable securities at June 30, 2025 consisted of the following:

(In thousands) Amortized

25 unchanged sentences

Total marketable securities $ 1,457,302 $ 878 $ ( 2,396 ) $ 1,455,784

As of March 31, 2025 and December 31, 2024, we held both current and non-current investments.

As of June 30, 2025 and December 31, 2024, we held both current and non-current investments.

Investments classified as current have maturities of less than one year.

Investments classified as non-current are those that:

(i) have a maturity of greater than one year, and (ii) we do not intend to liquidate within the next twelve months, although these funds are available for use and, therefore, are classified as available-for-sale.

As of March 31, 2025 and December 31, 2024, we held 156 and 213 debt securities, respectively, that were in an unrealized loss position for less than one year.

We did no t record an allowance for credit losses as of March 31, 2025 and December 31, 2024 related to these securities.

The aggregate fair value of debt securities in an unrealized loss position at March 31, 2025 and December 31, 2024 was $ 586.9 million and $ 768.1 million, respectively.

There were no individual securities that were in a significant unrealized loss position as of March 31, 2025 and December 31, 2024.

We regularly review the securities in an unrealized loss position and evaluate the current expected credit loss by considering factors such as historical experience,

market data, issuer-specific factors, and current economic conditions.

We do not consider these marketable securities to be impaired as of March 31, 2025 and December 31, 2024.

(i) have a maturity of greater

than one year, and (ii) we do not intend to liquidate within the next twelve months, although these funds are available for use and, therefore, are classified as available-for-sale.

As of June 30, 2025 and December 31, 2024, we held 123 and 213 debt securities, respectively, that were in an unrealized loss position for less than one year.

We did no t record an allowance for credit losses as of June 30, 2025 and December 31, 2024 related to these securities.

The aggregate fair value of debt securities in an unrealized loss position at June 30, 2025 and December 31, 2024 was $ 626.8 million and $ 768.1 million, respectively.

There were no individual securities that were in a significant unrealized loss position as of June 30, 2025 and December 31, 2024.

We regularly review the securities in an unrealized loss position and evaluate the current expected credit loss by considering factors such as historical experience, market data, issuer-specific factors, and current economic conditions.

We do not consider these marketable securities to be impaired as of June 30, 2025 and December 31, 2024.

Inventory, which consists of commercial supply of PYRUKYND®, consisted of the following:

(In thousands) March 31,

(In thousands) June 30,

2025 December 31,

8 unchanged sentences

The components of lease expense and other information related to leases were as follows:

Three Months Ended

Three Months Ended June 30, Six Months Ended June 30,

(In thousands) 2025 2024 2025 2024

1 unchanged sentence

Cash paid for amounts included in the measurement of operating lease liabilities 4,911 4,678 9,748 9,331

We have not entered into any material short-term leases or financing leases as of March 31, 2025.

In arriving at the operating lease liabilities as of March 31, 2025 and December 31, 2024, we applied the weighted-average incremental borrowing rate of 5.7 % for both periods over a weighted-average remaining lease term of 2.9 and 3.2 years, respectively.

As of March 31, 2025, undiscounted minimum rental commitments under non-cancelable leases were as follows:

We have not entered into any material short-term leases or financing leases as of June 30, 2025.

In arriving at the operating lease liabilities as of June 30, 2025 and December 31, 2024, we applied the weighted-average incremental borrowing rate of 5.7 % for both periods over a weighted-average remaining lease term of 2.7 and 3.2 years, respectively.

As of June 30, 2025, undiscounted minimum rental commitments under non-cancelable leases were as follows:

(In thousands)

5 unchanged sentences

In August 2021, we entered into a long-term sublease agreement for 13,000 square feet of the office space at 38 Sidney Street, Cambridge, Massachusetts, which expired on December 31, 2024.

In April 2022, we entered into a long-term sublease agreement for 27,000 square feet of the office space at 64 Sidney Street, Cambridge, Massachusetts, with the term of the lease running through April 2025.

In May 2023, we entered into a long-term sublease agreement for 7,407 square feet of office space on the first floor of 64 Sidney Street, Cambridge, Massachusetts, with the term of the lease running through April 2025.

We recorded operating sublease income of $ 1.3 million and $ 1.6 million for the three months ended March 31, 2025 and 2024, respectively, in other income, net in the condensed consolidated statements of operations.

We hold security deposits from our sublessees of approximately $ 0.9 million which is recorded within other non-current assets on our condensed consolidated balance sheet.

As of March 31, 2025, the future minimum lease payments to be received under the long-term sublease agreements were as follows:

In April 2022, we entered into a long-term sublease agreement for 27,000 square feet of the office space at 64 Sidney Street, Cambridge, Massachusetts, which expired on April 30, 2025.

In May 2023, we entered into a long-term sublease agreement for 7,407 square feet of office space on the first floor of 64 Sidney Street, Cambridge, Massachusetts, which expired on July 31, 2025.

In July 2025, we entered into a long-term sublease agreement with a new tenant for the same space, which will begin in November 2025 with the term of the lease running through February 2028.

We recorded operating sublease income of $ 0.5 million and $ 1.6 million for the three months ended June 30, 2025 and 2024, respectively, and $ 1.8 million and $ 3.2 million for the six months ended June 30, 2025 and 2024, respectively, in other income, net in the condensed consolidated statements of operations.

We hold security deposits from our sublessee of approximately $ 0.1 million which is recorded within other non-current assets on our condensed consolidated balance sheet.

As of June 30, 2025, the future minimum lease payments to be received under the long-term sublease agreements were as follows:

(In thousands)

Remaining 2025 $ 31

Accrued Expenses

Accrued expenses consisted of the following:

(In thousands) March 31,

(In thousands) June 30,

2025 December 31,

10 unchanged sentences

Product revenue, net, were as follows:

Three Months Ended March 31,

Three Months Ended June 30, Six Months Ended June 30,

(In thousands) 2025 2024 2025 2024

15 unchanged sentences

We currently estimate product return and replacement liabilities using the expected value method, based on available industry data, including our visibility into the inventory remaining in the distribution channel.

The following table summarizes balances and activity in each of the product revenue allowance and reserve categories for the three months ended March 31, 2025:

The following table summarizes balances and activity in each of the product revenue allowance and reserve categories for the six months ended June 30, 2025:

(In thousands) Contractual Adjustments Government Rebates Returns/ Replacement Total

4 unchanged sentences

Payments/returns relating to sales in the prior years ( 202 ) ( 462 ) — ( 664 )

Balance at March 31, 2025 $ 102 $ 1,494 $ 613 $ 2,209

Balance at June 30, 2025 $ 123 $ 1,679 $ 745 $ 2,547

Total revenue-related reserves above, included in our condensed consolidated balance sheets, are summarized as follows:

(In thousands) March 31, 2025 December 31, 2024

(In thousands) June 30, 2025 December 31, 2024

Reduction of accounts receivable $ 104 $ 124

1 unchanged sentence

Total revenue-related reserves $ 2,547 $ 2,096

The following table presents changes in our contract assets during the three months ended March 31, 2025:

(In thousands) December 31, 2024 Additions Deductions March 31, 2025

The following table presents changes in our contract assets during the six months ended June 30, 2025:

(In thousands) December 31, 2024 Additions Deductions June 30, 2025

Contract assets (1)

9 unchanged sentences

There are no outstanding equity awards under the 2007 Plan.

our equity incentive plans as inducements material to their respective entry into employment with us in accordance with Nasdaq Listing Rule 5635(c)(4).

As of March 31, 2025, the maximum number of shares reserved under the 2013 Plan, the 2023 Plan and the inducement grants described above was 10,325,619 , and we had 1,215,876 shares available for future issuance under the 2023 Plan.

In connection with the start of employment of our Chief Executive Officer and Chief Financial Officer in 2022, our Chief Commercial Officer in 2023, and our Chief Corporate Development and Strategy Officer in March 2025, our Board of Directors granted each of them equity awards in the form of stock options, RSUs and PSUs, which awards were made outside our equity incentive plans as inducements material to their respective entry into employment with us in accordance with Nasdaq Listing Rule 5635(c)(4).

As of June 30, 2025, the maximum number of shares reserved under the 2013 Plan, the 2023 Plan and the inducement grants described above was 12,661,855 , and we had 3,664,151 shares available for future issuance under the 2023 Plan.

Stock options

The following table presents stock option activity for the three months ended March 31, 2025:

The following table presents stock option activity for the six months ended June 30, 2025:

Stock Options Weighted-Average

5 unchanged sentences

Expired ( 210,536 ) 106.49

Outstanding at March 31, 2025 6,378,183 $ 40.73

Exercisable at March 31, 2025 4,021,549 $ 45.85

Vested and expected to vest at March 31, 2025 6,378,183 $ 40.73

At March 31, 2025, there was approximately $ 38.1 million of total unrecognized compensation expense related to unvested stock option awards, which we expect to recognize over a weighted-average period of approximately 2.81 years.

Outstanding at June 30, 2025 6,424,575 $ 40.01

Exercisable at June 30, 2025 4,243,623 $ 44.21

Vested and expected to vest at June 30, 2025 6,424,575 $ 40.01

At June 30, 2025, there was approximately $ 35.8 million of total unrecognized compensation expense related to unvested stock option awards, which we expect to recognize over a weighted-average period of approximately 2.57 years.

Restricted stock units

The following table presents RSU activity for the three months ended March 31, 2025:

The following table presents RSU activity for the six months ended June 30, 2025:

Stock Units Weighted-Average

4 unchanged sentences

Forfeited ( 93,407 ) 30.56

Unvested shares at March 31, 2025 2,171,527 $ 31.89

As of March 31, 2025, there was approximately $ 61.2 million of total unrecognized compensation expense related to RSUs, which we expect to recognize over a weighted-average period of approximately 2.30 years.

Unvested shares at June 30, 2025 2,096,123 $ 31.90

As of June 30, 2025, there was approximately $ 53.6 million of total unrecognized compensation expense related to RSUs, which we expect to recognize over a weighted-average period of approximately 2.10 years.

Performance-based stock units

The following table presents PSU activity for the three months ended March 31, 2025:

The following table presents PSU activity for the six months ended June 30, 2025:

Stock Units Weighted-Average

2 unchanged sentences

Granted 185,450 33.25

Unvested shares at March 31, 2025 560,033 $ 30.67

Vested ( 83,027 ) 26.35

Unvested shares at June 30, 2025 477,006 $ 31.47

Stock-based compensation expense associated with these PSUs is recognized if the underlying performance condition is considered probable of achievement using our management’s best estimates.

As of March 31, 2025, there was no unrecognized compensation expense related to PSUs with performance-based vesting criteria that are considered probable of achievement, and $ 17.2 million of total unrecognized compensation expense related to PSUs with performance-based vesting criteria that are considered not probable of achievement.

As of June 30, 2025, there was no unrecognized compensation expense related to PSUs with performance-based vesting criteria that are considered probable of achievement, and $ 15.0 million of total unrecognized compensation expense related to PSUs with performance-based vesting criteria that are considered not probable of achievement.

2013 Employee Stock Purchase Plan

In June 2013, our Board of Directors adopted, and in July 2013 our stockholders approved, the 2013 Employee Stock Purchase Plan, or the 2013 ESPP.

We issued and sold 52,092 and 52,514 shares of common stock during the three months ended March 31, 2025 and 2024, respectively, under the 2013 ESPP.

The 2013 ESPP provides participating employees with the opportunity

to purchase up to an aggregate of 2,363,636 shares of our common stock.

As of March 31, 2025, we had 1,531,142 shares of common stock available for future issuance under the 2013 ESPP.

We issued and sold 52,092 and 52,514 shares of common stock during the six months ended June 30, 2025 and 2024, respectively, under the 2013 ESPP.

The 2013 ESPP provides participating employees with the opportunity to purchase up to an aggregate of 2,363,636 shares of our common stock.

As of June 30, 2025, we had 1,531,142 shares of common stock available for future issuance under the 2013 ESPP.

Stock-based compensation expense

1 unchanged sentence

Three Months Ended

June 30, Six Months Ended

(In thousands) 2025 2024 2025 2024

1 unchanged sentence

Restricted stock units 7,507 6,211 14,191 11,177

Performance-based stock units 2,188 750 2,188 750

Employee stock purchase plan 375 243 650 440

1 unchanged sentence

Expenses related to stock options and stock-based awards were allocated as follows in the condensed consolidated statements of operations:

Three Months Ended

Three Months Ended June 30, Six Months Ended June 30,

(In thousands) 2025 2024 2025 2024

5 unchanged sentences

Diluted net income (loss) per share is calculated by adjusting the weighted-average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury stock method.

For purposes of the dilutive net income (loss) per share calculation, stock options, RSUs and PSUs for which the performance and market vesting conditions, respectively, have been deemed probable, and 2013 ESPP shares are considered to be common stock equivalents, while PSUs with performance and market vesting conditions, respectively, that were not deemed probable as of March 31, 2025 are not considered to be common stock equivalents.

For purposes of the dilutive net income (loss) per share calculation, stock options, RSUs and PSUs for which the performance and market vesting conditions, respectively, have been deemed probable, and 2013 ESPP shares are considered to be common stock equivalents, while PSUs with performance and market vesting conditions, respectively, that were not deemed probable as of June 30, 2025 are not considered to be common stock equivalents.

We utilize the control number concept in the computation of diluted earnings per share to determine whether potential common stock equivalents are dilutive.

3 unchanged sentences

Basic and diluted net loss per share was the same for all periods presented.

The following common stock equivalents were excluded from the calculation of diluted net income (loss) per share applicable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:

Three Months Ended

The following common stock equivalents were excluded from the calculation of diluted net loss per share applicable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:

Three Months Ended June 30,

Stock options 6,424,575 5,996,025

8 unchanged sentences

In making these decisions, our CEO uses consolidated financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets.

The CODM performs this assessment based on the Company’s consolidated net income (loss).

Through this analysis, the CODM assesses performance by comparing actual consolidated net income (loss) versus the budget, and then decides how to allocate resources to invest in the Company’s research and development programs.

The measure of segment assets is reported on the consolidated balance sheets as total assets.

The CODM performs this assessment based on our consolidated net income (loss).

The measure of segment assets is reported on the condensed consolidated balance sheets as total assets.

The following table contains additional information on our consolidated revenue and net loss, including significant segment expenses:

Three Months Ended

Three Months Ended June 30, Six Months Ended June 30,

(In thousands) 2025 2024 2025 2024

6 unchanged sentences

*Other segment items primarily include cost of sales, other research and development expenses and interest income.

Subsequent Events

On July 4, 2025, the One Big Beautiful Bill Act, or OBBBA, was enacted in the United States, which includes significant changes to federal tax law and other regulatory provisions that may impact the Company.

We are currently evaluating the impact of the OBBBA on our financial condition and results of operations.

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