What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-08-06 compared with 2025-05-08 · 86 added, 86 removed, 160 unchanged (52% of the section changed)

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We are a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer.

Our clinical-stage portfolio includes infectious disease programs for Chronic Hepatitis Delta (CHD) and Chronic Hepatitis B (CHB) infections and multiple dual-masked T-cell engagers (TCEs) across validated targets in solid tumor indications.

Our clinical-stage portfolio includes programs for Chronic Hepatitis Delta (CHD) and multiple dual-masked T-cell engagers (TCEs) across validated targets in solid tumor indications.

We also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.

Our clinical development pipeline consists of investigational therapies targeting hepatitis delta virus (HDV) and various solid tumors.

In HDV, we enrolled the first patient in our phase 3 ECLIPSE registrational program in the first quarter of 2025.

In HDV, ECLIPSE registrational program is fully underway with all three trials initiated.

Should the ECLIPSE program yield positive results that support regulatory approval and subsequent commercial launch, we believe the combination has the potential to be a new standard of care for hepatitis delta patients, for whom approved treatment options are either limited or unavailable.

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VIR-5818 in patients with HER2-expressing tumors and VIR-5500 in patients with PSMA-expressing metastatic castration-resistant prostate cancer (mCRPC).

We are also advancing our third TCE program,VIR-5525, in patients with EGFR-expressing tumors, with phase 1 clinical studies expected to begin in the second quarter of 2025.

We are also developing therapeutic candidates in hepatitis B, HIV cure, and other solid tumors, leveraging our expertise and platform strengths.

We are also advancing our third TCE program, VIR-5525, in patients with EGFR-expressing tumors, with the first patient dosed in phase 1 clinical studies in July 2025.

We are also developing therapeutic candidates in HIV cure, and other solid tumors, leveraging our expertise and platform strengths.

We have an industry-leading management team and board of directors with significant immunology, infectious diseases, and oncology experience, including a proven track record of progressing product candidates from early-stage research through clinical development, and worldwide regulatory approval and commercialization experience.

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Significant Developments

Following is a summary of selected significant developments affecting our business that occurred since the filing of our Annual Report on Form 10-K for the period ended December 31, 2024.

For additional developments or for a more comprehensive discussion of certain developments below, see our Annual Report on Form 10-K for the year ended December 31, 2024.

Chronic Hepatitis Delta (CHD)

• ECLIPSE 1, the first Phase 3 trial of our registrational program in CHD enrolled its first patient in March 2025 and is progressing as planned.

The clinical trial will assess the efficacy and safety of tobevibart and elebsiran compared to deferred treatment in regions such as the U.S.

where bulevirtide is not available or other regions where its access is limited.

• We are advancing plans for the initiation of ECLIPSE 2, a Phase 3 trial that will evaluate the efficacy and safety of switching to tobevibart and elebsiran in people with CHD who have not achieved viral suppression with bulevirtide therapy.

• We plan to share Phase 2 SOLSTICE subgroup analysis data in CHD in a poster presentation at the European Association for the Study of the Liver (EASL) Congress 2025.

The poster was selected by EASL to be highlighted during the poster tour on May 8, 2025.

• Tobevibart and elebsiran combination therapy is supported by multiple U.S.

and EU regulatory designations, including U.S.

Food and Drug Administration (FDA) Breakthrough Therapy designation, U.S.

FDA Fast Track designation, European Priority Medicines (PRIME) designation and European Orphan Drug designation, signifying the significant unmet need in CHD.

• VIR-5818, the only dual-masked HER2-targeting TCE in clinical trials, continues to advance through dose escalation as a monotherapy, and in combination with pembrolizumab, in multiple tumor types, including metastatic breast cancer and metastatic colorectal cancer.

◦ In early Phase 1 data reported in January 2025, VIR-5818 showed tumor shrinkage across various tumor types in 50% (10/20) of participants receiving doses ≥400 µg/kg, with confirmed partial responses in 33% (2/6) of participants with HER2-positive colorectal cancer (CRC).

• VIR-5500, the only dual-masked PSMA-targeting TCE in clinical trials, continues to advance through dose escalation aiming to further optimize dosing and efficacy.

◦ In early Phase 1 data reported in January 2025, VIR-5500 showed PSA reductions in 100% (12/12) of metastatic castration resistant prostate cancer (mCRPC) patients after an initial dose ≥120 µg/kg.

PSA 50 response was confirmed in 58% (7/12) of participants.

Following is a summary of selected significant developments affecting our business that occurred since the filing of our Quarterly Report on Form 10-Q for the period ended March 31, 2025.

For additional developments or for a more comprehensive discussion of certain developments below, see our Annual Report on Form 10-K for the year ended December 31, 2024 and our Quarterly Report on Form 10-Q for the period March 31, 2025.

• ECLIPSE registrational program is fully underway following enrollment of the first patients in ECLIPSE 2 and ECLIPSE 3.

◦ ECLIPSE 2 will compare the combination of tobevibart and elebsiran to continued bulevirtide monotherapy in participants with CHD who have not achieved undetectable hepatitis delta virus RNA despite bulevirtide treatment.

◦ ECLIPSE 3 will compare the combination of tobevibart and elebsiran to bulevirtide monotherapy in participants with CHD who have not received bulevirtide before.

• ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies, including agencies in the U.S.

ECLIPSE 3 is expected to provide important supportive data to help establish access and reimbursement in key markets.

• First patient dosed in the Phase 1 clinical study of VIR-5525, our investigational PRO-XTEN ™ dual-masked T-cell engager (TCE) targeting EGFR.

◦ VIR-5525 will be evaluated for the treatment of a variety of EGFR-expressing solid tumors in areas of high unmet need such as non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), and cutaneous squamous cell carcinoma (cSCC).

◦ Our Phase 1 clinical trial of PRO-XTEN™ masked VIR-5818 evaluates the TCE in multiple tumor types, including metastatic breast cancer and metastatic CRC.

◦ VIR-5818 is the only dual-masked HER2-targeting TCE in clinical development.

◦ We have completed monotherapy dose escalation and are analyzing the data while continuing to dose escalate VIR-5818 in combination with pembrolizumab.

• VIR-5500, the only dual-masked PSMA-targeting TCE in clinical trials, continues to advance through dose escalation.

◦ We received Investigational New Drug clearance from the U.S.

Food and Drug Administration (FDA) to evaluate VIR-5500 in combination with androgen receptor pathway inhibitors for earlier lines of metastatic castration-resistant prostate cancer treatment, unlocking new opportunities to transform patient lives.

• Early Phase 1 data for VIR-5818 and VIR-5500 reported in January 2025 showed promising safety profiles for both clinical candidates, with maximum tolerated dose not yet reached, no dose-limiting cytokine release syndrome (CRS) observed and no CRS greater than grade 2 reported.

• Initial clinical data demonstrate the PRO-XTEN ™ masking technology’s potential to minimize systemic toxicity while enabling selective killing of cancer cells in the tumor microenvironment, minimizing CRS and expanding the therapeutic index compared to traditional therapeutic approaches.

PRO-XTEN™ is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.

• We plan to initiate a Phase 1 study of VIR-5525, our PRO-XTEN™ dual-masked EGFR-targeting TCE, in the second quarter of 2025, to evaluate its potential across a number of solid tumor indications.

Chronic Hepatitis B (CHB)

• We will present functional cure data from the 24-week follow-up of the MARCH Part B Phase 2 clinical study evaluating combinations of tobevibart and elebsiran, alone, or in combination with pegylated interferon alfa (PEG-IFNα) at the EASL Congress 2025 on May 9, 2025.

• Future advancement in CHB by us will be contingent on securing a worldwide development and commercialization partner outside China Territory (People’s Republic of China, Hong Kong, Taiwan, and Macau).

• We presented functional cure data from the 24-week follow-up of the MARCH Part B Phase 2 clinical study evaluating combinations of tobevibart and elebsiran, alone, or in combination with pegylated interferon alfa (PEG-IFNα) at the European Association for the Study of the Liver (EASL) Congress 2025 on May 9, 2025.

The study-defined primary endpoint, proportion of participants with undetectable hepatitis B surface antigen (HBsAg) at 24 weeks post-end of treatment, was achieved by 17% (3/18) and 21% (3/14) of participants with baseline HBsAg<1,000 IU/mL receiving tobevibart and elebsiran without or with PEG-IFNα, respectively.

Preclinical Pipeline Candidates

• We continue to progress multiple undisclosed PRO-XTEN™ dual-masked TCEs against clinically validated targets with potential applications across a number of solid tumors.

These preclinical candidates integrate the PRO-XTEN™ masking technology with novel TCEs discovered and engineered using Vir Biotechnology’s antibody discovery platform and our proprietary dAIsY™ ( d ata AI s tructure and antibod y ) AI engine.

• We have advanced a broadly neutralizing antibody to development candidate status in our HIV cure program in collaboration with the Gates Foundation.

Corporate Update

• In January 2025, we announced positive initial Phase 1 dose escalation data for two of our PRO-XTEN™ dual-masked TCEs.

• During the quarter, Vir Biotechnology and Alnylam Pharmaceuticals, Inc.

(Alnylam) amended and restated their collaboration agreement (Restated Alnylam Agreement), with Alnylam electing not to opt-in to its profit-sharing option for elebsiran in CHB and CHD indications.

The amended agreement provides us with the flexibility to pursue commercialization partners in markets outside the U.S.

• Leveraging our immune system expertise and platform strengths, we continue to progress multiple undisclosed PRO-XTEN™ dual-masked TCEs against clinically validated targets with potential applications across a number of solid tumors.

These preclinical candidates integrate the PRO-XTEN™ masking technology with novel TCEs discovered and engineered using our antibody discovery platform and our proprietary dAIsY™ (data AI structure and antibody) AI engine.

Our Collaboration, License and Grant Agreements

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Components of Operating Results

Other than sotrovimab, we have not obtained regulatory approval for our product candidates, and we do not expect to generate any significant revenue from the sale of our other product candidates until we complete clinical development, submit regulatory filings and receive approvals from the applicable regulatory bodies for such product candidates, if ever.

Other than sotrovimab, we have not obtained regulatory approval for our product candidates, and we do not expect to generate any significant revenue from the sale of our product candidates until we complete clinical development, submit regulatory filings and receive approvals from the applicable regulatory bodies for such product candidates, if ever.

In December 2024, the FDA revoked EUA granted to sotrovimab in May 2021.

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Selling, General and Administrative

Our selling, general and administrative expenses consist primarily of personnel-related expenses for personnel in executive, finance and other administrative functions, facilities and other allocated expenses, other expenses for outside professional services, including legal, audit and accounting services, insurance costs and change in fair value of certain contingent consideration obligations arising from business acquisitions.

professional services, including legal, audit and accounting services, insurance costs and change in fair value of certain contingent consideration obligations arising from business acquisitions.

Personnel-related expenses consist of salaries, benefits and stock-based compensation.

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Restructuring, long-lived asset impairment and related charges

Restructuring, long-lived asset impairment and related charges consist primarily of charges incurred in connection with our cost saving initiatives implemented in 2024 and 2023.

Restructuring, long-lived asset impairment and related charges consist primarily of charges incurred in connection with our cost saving initiatives.

Change in Fair Value of Equity Investments

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Interest income consists of interest earned on our cash, cash equivalents and investments.

Other Expense, Net

Other expense, net consists of gains and losses from foreign currency transactions and investment management expenses.

Provision for Income Taxes

Provision for income taxes consists primarily of income taxes on our domestic and foreign operations.

Other Income (Expense), Net

Other income (expense), net consists of gains and losses from foreign currency transactions and investment management expenses.

(Provision for) Benefit from Income Taxes

(Provision for) benefit from income taxes consists primarily of income taxes on our domestic and foreign operations.

Results of Operations

Comparison of the Three Months Ended March 31, 2025 and 2024

Comparison of the Three and Six Months Ended June 30, 2025 and 2024

The following table summarizes our results of operations for the periods presented (in thousands):

Three Months Ended

2025 2024 Change

June 30, Six Months Ended

2025 2024 Change 2025 2024 Change

Collaboration revenue $ (495) $ 55 $ (550) $ (565) $ (932) $ 367

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Interest income 10,785 18,846 (8,061) 23,073 40,129 (17,056)

Other expense, net (72) (287) 215

Other income (expense), net 226 (535) 761 154 (822) 976

Total other income 7,629 18,740 (11,111) 26,227 33,821 (7,594)

Loss before provision for income taxes (120,949) (65,000) (55,949)

Provision for income taxes (16) (276) 260

Loss before (provision for) benefit from income taxes (110,788) (139,890) 29,102 (231,737) (204,890) (26,847)

(Provision for) benefit from income taxes (170) 1,512 (1,682) (186) 1,236 (1,422)

Net loss $ (110,958) $ (138,378) $ 27,420 $ (231,923) $ (203,654) $ (28,269)

The change in collaboration revenue for the three months ended March 31, 2025 compared to the same period in 2024 was nominal.

The decrease in contract revenue for the three months ended March 31, 2025 compared to the same period in 2024 was primarily due to $51.7 million of deferred revenue recognized during the first quarter of 2024 when GSK’s rights to select up to two additional non-influenza target pathogens expired on March 25, 2024.

The decrease in grant revenue for the three months ended March 31, 2025 compared to the same periods in 2024 was primarily due to lower revenue recognized in accordance with our agreement with BARDA and the Gates Foundation.

The change in collaboration revenue for the three and six months ended June 30, 2025 compared to the same periods in 2024 was nominal.

The increase in contract revenue for the three months ended June 30, 2025 compared to the same period in 2024 was nominal.

The decrease in contract revenue for the six months ended June 30, 2025 compared to the same period in 2024 was primarily due to $51.7 million of deferred revenue recognized during the first quarter of 2024 when GSK’s rights to select up to two additional non-influenza target pathogens expired on March 25, 2024.

The decrease in grant revenue for the three and six months ended June 30, 2025 compared to the same periods in 2024 was primarily due to lower revenue recognized in accordance with our agreement with BARDA and the Gates Foundation.

Certain grant agreements with the Gates Foundation expired during the first half of 2025.

We terminated our agreement with BARDA on December 31, 2024.

The decrease in cost of revenue for the three months ended March 31, 2025 compared to the same period in 2024 was nominal.

Cost of Revenue

The decrease in cost of revenue for the three and six months ended June 30, 2025 compared to the same periods in 2024 was nominal.

Research and Development Expenses

The following table shows the primary components of our research and development expenses for the periods presented (in thousands):

Three Months Ended March 31,

2025 2024 Change

Contract manufacturing $ 9,336 $ 9,669 $ (333)

Three Months Ended June 30, Six Months Ended

2025 2024 Change 2025 2024 Change

Clinical costs $ 20,361 $ 12,318 $ 8,043 $ 40,967 $ 23,925 $ 17,042

Contract manufacturing 14,063 10,524 3,539 23,399 20,193 3,206

Personnel 33,165 43,670 (10,505) 66,883 89,860 (22,977)

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Total research and development expenses $ 97,509 $ 105,113 $ (7,604) $ 216,154 $ 205,238 $ 10,916

The increase in research and development expenses for the three months ended March 31, 2025 compared to the same period in 2024 was primarily due to:

• higher license, collaborations and contingent consideration expenses related to a $30.0 million expense (paid in April 2025) in connection with signing the Restated Alnylam Agreement and milestone payments due upon the enrollment of the first patient in phase 3 ECLIPSE registrational program for CHD.

The decrease in research and development expenses for the three months ended June 30, 2025 compared to the same periods in 2024 was primarily due to:

• lower other R&D expenses related to de-prioritized R&D programs and other ongoing cost savings;

• lower personnel expenses associated with headcount reductions;

partially offset by:

• higher clinical cost due to the initiation of our ECLIPSE registrational program and progression of our oncology programs;

• higher license, collaborations and contingent consideration expenses related to the increase in fair value of contingent consideration obligation for the potential future milestone payments in connection with our CHD program.

The increase in research and development expenses for the six months ended June 30, 2025 compared to the same period in 2024 was primarily due to:

• higher license, collaborations and contingent consideration expenses related to a $30.0 million expense in connection with signing the Restated Alnylam Agreement and milestone payments due upon the enrollment of the first patient in ECLIPSE registrational program for CHD and, to lesser extent, the increase in fair value of contingent consideration obligation for the potential future milestone payments in connection with our CHD program.

As part of the Restated Alnylam Agreement, Alnylam had elected to not opt-in to the profit-sharing arrangement for elebsiran, resulting in a milestone and royalty-based structure rather than a profit-sharing model.

We are solely responsible for the development, manufacturing, and commercialization activities associated with elebsiran;

• higher clinical cost due to the initiation of our phase 3 ECLIPSE registrational program and newer oncology programs;

• higher clinical cost due to the initiation of our phase 3 ECLIPSE registrational program and progression of our oncology programs;

partially offset by:

• lower contract manufacturing expenses related to our de-prioritized programs partially offset by activities associated with our newer oncology programs;

• lower other R&D expenses related to de-prioritized R&D programs and other ongoing cost savings;

• lower personnel expenses associated with headcount reductions.

• lower other R&D expenses related to de-prioritized R&D programs and other ongoing cost savings, including the closing of our St.

Louis, Missouri and Portland, Oregon sites.

Selling, General and Administrative Expenses

The decrease in selling, general and administrative expenses for the three months ended March 31, 2025 compared to the same periods in 2024 was primarily due to ongoing cost saving realized through headcount reductions and other initiatives.

The decrease in selling, general and administrative expenses for the three and six months ended June 30, 2025 compared to the same periods in 2024 was primarily due to efficiencies and cost savings from previously announced restructuring initiatives.

Restructuring, long-lived assets impairment and related charges

The decrease in restructuring, long-lived assets impairment and related charges for the three months ended March 31, 2025 compared to the same period in 2024 was nominal.

Our restructuring plans implemented in prior years were substantially completed by the end of 2024.

The decrease in restructuring, long-lived assets impairment and related charges for the three and six months ended June 30, 2025 compared to the same periods in 2024 was due to the substantial completion of previously announced restructuring initiatives by the end of 2024.

Change in Fair Value of Equity Investments

Our equity investment consisted solely of shares of Brii Bio Parent, which is a marketable equity investment and remeasured to fair value at each reporting period.

For the three months ended March 31, 2025, we recognized an unrealized gain of $6.4 million due to the change in fair value, compared to an unrealized loss of $5.9 million for the same period in 2024.

Our equity investment consisted solely of shares of Brii Bio Parent, which is a marketable equity investment and remeasured to fair value at each reporting date.

For the three and six months ended June 30, 2025, we recognized an unrealized loss of $3.4 million and unrealized gain of $3.0 million due to the change in fair value, respectively, compared to an unrealized gain of $0.4 million and unrealized loss of $5.5 million for the same periods in 2024, respectively.

Interest Income

The decrease in interest income for the three months ended March 31, 2025 compared to the same periods in 2024 was primarily due to lower balances of cash, cash equivalents, and investments.

Other Expense, Net

The change in other expense, net for the three months ended March 31, 2025 compared to the same period in 2024 was nominal.

Provision for Income Taxes

The decrease in the provision for income taxes for the three months ended March 31, 2025 compared to the same periods in 2024 was nominal.

Liquidity, Capital Resources and Capital Requirements

Sources of Liquidity

The decrease in interest income for the three and six months ended June 30, 2025 compared to the same periods in 2024 was primarily due to lower balances of cash, cash equivalents, and investments.

Other Income (Expense), Net

The change in other income (expense), net for the three and six months ended June 30, 2025 compared to the same periods in 2024 was nominal.

(Provision for) Benefit from Income Taxes

The provision for income taxes for the three and six months ended June 30, 2025 was nominal.

The benefit for income taxes for the three and six months ended June 30, 2024 was primarily due to favorable adjustments in estimated tax payable.

On July 4, 2025, the One Big Beautiful Bill Act (OBBBA) was signed into law by President Trump, which includes permanent extensions of most expiring Tax Cuts and Jobs Act provisions and changes to international tax provisions.

We are evaluating the potential impacts of the OBBBA.

Liquidity, Capital Resources and Capital Requirements Sources of Liquidity

To date, we have financed our operations primarily through sales of our common stock from our initial public offering and subsequent follow-on offering, sales of our convertible preferred securities, and payments received under our grant and collaboration agreements.

As of March 31, 2025, we had $1.02 billion in cash, cash equivalents, and investments and $94.4 million in restricted cash and cash equivalents, which included the $75.0 million subject to VIR-5525 achieving “first in human dosing” by 2026.

As of March 31, 2025, our accumulated deficit was $880.7 million.

As of June 30, 2025, we had $892.1 million in cash, cash equivalents, and investments and $95.2 million in restricted cash and cash equivalents, which included the $75.0 million subject to VIR-5525 achieving “first in human dosing” by 2026.

In July 2025, the first patient was dosed in phase 1 study evaluating VIR-5525.

As of June 30, 2025, our accumulated deficit was $991.7 million.

In November 2023, we entered into a sales agreement (Sales Agreement) with Cowen and Company, LLC, as sales agent (TD Cowen), pursuant to which the Company may from time to time offer and sell shares of its common stock for an aggregate offering price of up to $300.0 million, through or to TD Cowen, acting as sales agent or principal.

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We will pay TD Cowen a commission of up to 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide TD Cowen with customary indemnification and contribution rights.

As of March 31, 2025, no shares have been issued under the Sales Agreement.

As of June 30, 2025, no shares have been issued under the Sales Agreement.

Funding Requirements and Conditions

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In December 2024, the FDA revoked EUA granted to sotrovimab in May 2021.

We do not expect to generate significant revenue from the sale of our other product candidates until we complete clinical development, submit regulatory filings and receive approvals from the applicable regulatory bodies for such product candidates, if ever.

We do not expect to generate significant revenue from the sale of our product candidates until we complete clinical development, submit regulatory filings and receive approvals from the applicable regulatory bodies for such product candidates, if ever.

We may continue to incur net losses for the foreseeable future.

Based upon our current operating plan, we believe that our existing cash, cash equivalents and investments as of March 31, 2025 as noted above will enable us to fund our operations for at least the next 12 months from the filing date of this Quarterly Report on Form 10-Q.

Based upon our current operating plan, we believe that our existing cash, cash equivalents and investments as of June 30, 2025 as noted above will enable us to fund our operations for at least the next 12 months from the filing date of this Quarterly Report on Form 10-Q.

However, our operating plan may change as a result of many factors currently unknown to us, and we may need to raise additional capital to complete the development and commercialization of our product candidates and fund certain of our existing manufacturing and other commitments.

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Our primary operating lease arrangements are for office and laboratory spaces located in California and Switzerland with contractual lease periods expiring between 2033 and 2035.

As of March 31, 2025, we expect to make total lease payments of approximately $120.5 million through 2035.

As of June 30, 2025, we expect to make total lease payments of approximately $128.4 million through 2035.

To date, we have entered into collaboration, license and acquisition agreements where the payment obligations are contingent upon future events such as our achievement of specified development, regulatory and commercial milestones, and we are required to make royalty payments in connection with the sale of products developed under those agreements.

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For information related to our future commitments under our facilities and manufacturing agreements.

see Note 10—Commitments and Contingencies to our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024.

see Note 7—Commitments and Contingencies to our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, and Note 10—Commitments and Contingencies to our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024.

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements.

The following table summarizes our cash flows for the periods presented (in thousands):

Three Months Ended

Six Months Ended

Net cash (used in) provided by:

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Financing activities 2,644 3,094

Net increase (decrease) in cash, cash equivalents and restricted cash and cash equivalents $ 49,300 $ (80,818)

Net (decrease) increase in cash, cash equivalents and restricted cash and cash equivalents $ (12,417) $ 55,884

Operating Activities

Cash used in operating activities is derived by adjusting our net loss for non-cash items and changes in operating assets and liabilities.

Cash used in operating activities during the three months ended March 31, 2025 decreased compared to the same period in 2024 primarily due to ongoing cost saving realized through headcount reductions, the closing of our St.

Cash used in operating activities during the six months ended June 30, 2025 increased compared to the same period in 2024 primarily due to milestone payments related to the enrollment of the first patient in ECLIPSE registrational program for CHD and overall higher payments for clinical costs associated with CHD and oncology programs, partially offset by ongoing cost saving realized through headcount reductions, the closing of our St.

Louis, Missouri and Portland, Oregon sites and de-prioritized R&D programs.

Investing Activities

Cash provided by investing activities during the three months ended March 31, 2025 increased compared to the same period in 2024 primarily due to higher cash provided by maturities and sales of investment, net of investment purchases.

Cash provided by investing activities during three months ended March 31, 2025 was primarily due to $301.9 million in proceeds received from investments that matured or sold during the year, partially offset by purchases of investments of $173.7 million.

Cash provided by investing activities during three months ended March 31, 2024 was primarily due to $592.7 million in proceeds received from investments that matured or sold during the period, partially offset by purchases of investments of $562.9 million.

Cash provided by investing activities during the six months ended June 30, 2025 decreased compared to the same period in 2024 primarily due to lower cash provided by maturities and sales of investment, net of investment purchases.

Cash provided by investing activities during six months ended June 30, 2025 was primarily related to $553.2 million in proceeds received from investments that matured or sold, partially offset by purchases of investments of $366.1 million.

Cash provided by investing activities during six months ended June 30, 2024 was primarily due to $1.1 billion in proceeds received from investments that matured or sold, partially offset by purchases of investments of $834.3 million.

Financing Activities

The change in cash provided by financing activities during the three months ended March 31, 2025 compared to the same period in 2024 was nominal.

The change in cash provided by financing activities during the six months ended June 30, 2025 compared to the same period in 2024 was nominal.

Critical Accounting Policies and Estimates

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For more details on our critical accounting policies, refer to Note 2 — Summary of Significant Accounting Policies to our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024.

There have been no significant changes in our critical accounting policies during the three months ended March 31, 2025, as compared with those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.

There have been no significant changes in our critical accounting policies during the six months ended June 30, 2025, as compared with those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.

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 2. Management’s Discussion and Analysis