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Summit Therapeutics Inc.

For the period ended Jun 30, 2026. Filed Jul 23, 2026.

View on SEC.gov

About this filing

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

Jun 30, 2026 · Filed Jul 23, 2026

SMMT$16.33+15.1%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-03-31; filed 2026-04-30.

0001599298-26-000039

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-06-30; filed 2026-07-23.

0001599298-26-000068

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 148 previous paragraphs and 152 current paragraphs.

120 unchanged; 27 reworded; 5 added; 0 removed; 1 previous and 0 current paragraphs rearranged.

Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (5)

Current report

In July 2026, an updated analysis was conducted with a data cutoff date of June 2026 which analyzed OS when most western patients had discontinued treatment or completed two years of treatment. This analysis showed a consistent OS trend amongst western and Asian patients as western patients were followed for additional time on study reaching median follow-up of 23.2 months; Asian patients remained locked with a median follow-up time of 32.7 months from the primary analysis. A hazard ratio of 0.76 was observed for the full population; the 0.76 hazard ratio was observed in western patient subgroup, respectively, in this analysis. Ivonescimab continued to demonstrate an acceptable and manageable safety profile, that was consistent with previous Phase III data of ivonescimab plus chemotherapy with no additional safety signals noted. These OS results have been made available to the FDA, and more detailed data are intended to be presented at an upcoming medical conference.

Current report

In July 2026, the Company entered into a clinical trial collaboration with Arcus Biosciences, Inc (“Arcus”) to evaluate ivonescimab in combination with Arcus’ novel inhibitor of hypoxia-inducible factor 2-alpha, casdatifan, in clear cell renal cell carcinoma (the “Arcus Collaboration”). Both Arcus and the Company will contribute to the cost of the clinical study and each will provide study drug for purposes of conducting the clinical trial. There are no additional milestone payments or royalty sharing provisions thereafter.

Current report

In July 2026, an updated analysis was conducted with a data cutoff date of June 2026 which analyzed OS when most western patients had discontinued treatment or completed two years of treatment. This analysis showed a consistent OS trend amongst western and Asian patients as western patients were followed for additional time on study reaching median follow-up of 23.2 months; Asian patients remained locked with a median follow-up time of 32.7 months from the primary analysis. A hazard ratio of 0.76 was observed for the full population; the 0.76 hazard ratio was observed in western patient subgroup, respectively, in this analysis. Ivonescimab continued to demonstrate an acceptable and manageable safety profile, that was consistent with previous Phase III data of ivonescimab plus chemotherapy with no additional safety signals noted. These OS results have been made available to the FDA, and more detailed data are intended to be presented at an upcoming medical conference.

Current report

Additionally, at ASCO 2026, Summit presented new global Phase II ivonescimab data in metastatic microsatellite-stable CRC. Data generated was from a multi-center Phase II study conducted in the U.S. and China co-sponsored by Summit and Akeso, with data generated and analyzed by Summit and Akeso.

Current report

(1)In June 2026, the Company entered into an asset purchase agreement (the “APA”) with a third party. Pursuant to the APA, the Company sold the asset relating to the pharmaceutical compound known as ridinilazole. In consideration for such assignment of rights, the third party has made an upfront non-refundable payment to the Company of $0.5 million. Additionally, the third party has also agreed to make additional payments totaling $1.5 million that are contingent upon the achievement of certain regulatory milestones, sales-based milestone payments of up to $103 million, as well as quarterly royalty payments that are based on a single digit percentage of net sales for certain products covered by the assigned and transferred patent rights. The Company did not have any amounts capitalized related to the underlying portfolio of patents, nor was any write-down of assets recorded upon executing the APA. The Company received the payment of $0.5 million from the third party in June 2026 and recognized the $0.5 million within other income, net on the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2026. The Company does not have any ongoing obligations associated with the APA. As of June 30, 2026, the Company is unable to estimate the timing or likelihood of achieving the regulatory milestone payments, sales-based milestone payments, and the quarterly royalty payments.
Reworded paragraphs (27)

Previous wording

Patient enrollment was completed for the squamous cohort of HARMONi-3 in the first quarter of 2026. Previously, Summit announced its intention to perform an interim PFS analysis for the squamous cohort of the HARMONi-3 study in the second quarter of 2026 and final PFS analysis in the second half of 2026. To achieve statistical significance, there was a meaningfully higher bar than the upcoming planned final PFS analysis based on the minimal alpha spent on the interim analysis. At this early PFS interim analysis reviewed exclusively by the Independent Data Monitoring Committee (iDMC), the iDMC recommended that the study continue as planned. No safety concerns were noted, and the study continues to be double-blinded. There is no change to the previously guided timing of the preplanned final PFS analysis in the second half of 2026.

Current wording

Patient enrollment was completed for the squamous cohort of HARMONi-3 in the first quarter of 2026. Previously, Summit announced its intention to perform an interim PFS analysis for the squamous cohort of the HARMONi-3 study in the second quarter of 2026. To achieve statistical significance, there was a meaningfully higher bar than the upcoming planned final PFS analysis based on the minimal alpha spent on the interim analysis. At this early PFS interim analysis reviewed exclusively by the Independent Data Monitoring Committee (iDMC), the iDMC recommended that the study continue as planned. No safety concerns were noted, and the study continues to be double-blinded. The number of PFS events needed in the squamous cohort for the primary analysis is expected to be reached in the second half of 2026, and a planned early interim analysis for OS is expected to take place in conjunction with the primary PFS analysis. An interim analysis for overall survival independent of PFS is planned for the first half of 2027.

Previous wording

Enrollment in the non-squamous cohort of HARMONi-3 is expected to complete by the end of the second quarter of 2026. The Company expects to perform the PFS analysis for this cohort in the first half of 2027. Interim analyses for OS are planned to be conducted, based upon reaching prespecified numbers of events.

Current wording

Enrollment in the non-squamous cohort of the global HARMONi-3 study was completed in the second quarter of 2026. For this cohort, the number of events needed to conduct the PFS analysis is expected to be reached in the first half of 2027.

Previous wording

In June 2025, the Company entered into a clinical trial collaboration with Revolution Medicines Inc. (“RevMed”) to evaluate ivonescimab in combination with three RevMed RAS(ON) inhibitors (the “RevMed Collaboration”). In January 2026, the Company entered into a clinical trial collaboration with GSK plc to evaluate ivonescimab in combination with GSK’s novel B7-H3, risvutatug rezetecan, in multiple solid tumors (the “GSK Collaboration”). Neither the RevMed Collaboration nor the GSK Collaboration include upfront payments, milestone payments, or royalty sharing provisions. For the three months ended March 31, 2026, there was no cash consideration exchanged in connection with either the RevMed Collaboration or the GSK Collaboration.

Current wording

In June 2025, the Company entered into a clinical trial collaboration with Revolution Medicines Inc. (“RevMed”) to evaluate ivonescimab in combination with three RevMed RAS(ON) inhibitors (the “RevMed Collaboration”). In January 2026, the Company entered into a clinical trial collaboration with GSK plc to evaluate ivonescimab in combination with GSK’s novel B7-H3 ADC, risvutatug rezetecan, in multiple solid tumors (the “GSK Collaboration”). Neither the RevMed Collaboration nor the GSK Collaboration include upfront payments, milestone payments, or royalty sharing provisions. For the three and six months ended June 30, 2026, there was no cash consideration exchanged in connection with either the RevMed Collaboration or the GSK Collaboration.

Previous wording

Patient enrollment was completed for the squamous cohort of HARMONi-3 in the first quarter of 2026. Previously, Summit announced its intention to perform an interim PFS analysis for the squamous cohort of the HARMONi-3 study in the second quarter of 2026 and final PFS analysis in the second half of 2026. To achieve statistical significance, there was a meaningfully higher bar than the upcoming planned final PFS analysis based on the minimal alpha spent on the interim analysis. At this early PFS interim analysis reviewed exclusively by the Independent Data Monitoring Committee (iDMC), the iDMC recommended that the study continue as planned. No safety concerns were noted, and the study continues to be double-blinded. There is no change to the previously guided timing of the preplanned final PFS analysis in the second half of 2026.

Current wording

Patient enrollment was completed for the squamous cohort of HARMONi-3 in the first quarter of 2026. Previously, Summit announced its intention to perform an interim PFS analysis for the squamous cohort of the HARMONi-3 study in the second quarter of 2026. To achieve statistical significance, there was a meaningfully higher bar than the upcoming planned final PFS analysis based on the minimal alpha spent on the interim analysis. At this early PFS interim analysis reviewed exclusively by the Independent Data Monitoring Committee (iDMC), the iDMC recommended that the study continue as planned. No safety concerns were noted, and the study continues to be double-blinded. The number of PFS events needed in the squamous cohort for the primary analysis is expected to be reached in the second half of 2026, and a planned early interim analysis for OS is expected to take place in conjunction with the primary PFS analysis. An interim analysis for overall survival independent of PFS is planned for the first half of 2027.

Previous wording

Enrollment in the non-squamous cohort of HARMONi-3 is expected to complete by the end of the second quarter of 2026. The Company expects to perform the PFS analysis for this cohort in the first half of 2027. Interim analyses for OS are planned to be conducted, based upon reaching prespecified numbers of events.

Current wording

Enrollment in the non-squamous cohort of the global HARMONi-3 study was completed in the second quarter of 2026. For this cohort, the number of events needed to conduct the PFS analysis is expected to be reached in the first half of 2027.

Previous wording

In the first quarter of 2026, the Company announced that GORTEC (Groupe d'Oncologie Radiothérapie Tête Et Cou or Head and Neck Oncology and Radiotherapy Group), a cooperative group dedicated to Head and Neck Oncology, will initiate the Phase III clinical study, ILLUMINE (NCT07264075), which will evaluate ivonescimab monotherapy and ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, against monotherapy pembrolizumab in a three-arm study. The study is intended to be conducted in multiple countries in Europe and in China; Summit will consider the expansion of this study into the United States. The primary endpoint for the study is OS. The study, currently planned to enroll 780 patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (HNSCC), is expected to begin enrollment in the second quarter of 2026. Data supporting this study was previously presented at the 2024 European Society for Medical Oncology Annual Congress (“ESMO 2024”), whereby ivonescimab in combination with ligufalimab demonstrated an objective response rate of 60% in 20 patients with a median PFS of 7.1 months after a median follow-up time of 4.1 months; OS was not mature at the time of this analysis. At the time of data cut-off for this presentation, no patients receiving ivonescimab plus ligufalimab permanently discontinued drug treatment due to treatment-related adverse events.

Current wording

In the first quarter of 2026, the Company announced that GORTEC (Groupe d'Oncologie Radiothérapie Tête Et Cou or Head and Neck Oncology and Radiotherapy Group), a cooperative group dedicated to Head and Neck Oncology, will initiate the Phase III clinical study, ILLUMINE (NCT07264075), which will evaluate ivonescimab monotherapy and ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, against monotherapy pembrolizumab in a three-arm study. The study is intended to be conducted in multiple countries in Europe and in China; Summit will consider the expansion of this study into the United States. The primary endpoint for the study is OS. The study, currently planned to enroll 780 patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (HNSCC), began enrollment in the second quarter of 2026. Data supporting this study was previously presented at the 2024 European Society for Medical Oncology Annual Congress (“ESMO 2024”), whereby ivonescimab in combination with ligufalimab demonstrated an objective response rate of 60% in 20 patients with a median PFS of 7.1 months after a median follow-up time of 4.1 months; OS was not mature at the time of this analysis. At the time of data cut-off for this presentation, no patients receiving ivonescimab plus ligufalimab permanently discontinued drug treatment due to treatment-related adverse events.

Previous wording

In the fourth quarter of 2023, we began collaborating with multiple institutions globally and opened our investigator- sponsored trials program across several disease areas. We continued to expand this program in 2024 and 2025 in order to discover additional opportunities for ivonescimab, including in several tumors outside of our current development plan.

Current wording

In the fourth quarter of 2023, we began collaborating with multiple institutions globally and opened our investigator- sponsored trials program across several disease areas. We continued to expand this program in order to discover additional opportunities for ivonescimab, including in several tumors outside of our current development plan.

Previous wording

After announcing positive qualitative results for the HARMONi-6 trial, on April 23, 2025, detailed clinical trial results of the study were presented as part of the Presidential Symposium at the European Society for Medical Oncology’s 2025 Congress (“ESMO 2025”). Overall survival data from the HARMONi-6 trial is planned to be presented as a late breaking abstract for the plenary session at the ASCO 2026 Annual Meeting. The HARMONi-6 study evaluated ivonescimab in combination with platinum-based chemotherapy compared to tislelizumab (a PD-1 inhibitor) in combination with platinum-based chemotherapy in patients with previously untreated advanced NSCLC irrespective of PD-L1 expression. HARMONi-6, also referred to as AK112-306, is a single region, multi-center, double-blinded Phase III study conducted in China sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso.

Current wording

After announcing positive qualitative results for the HARMONi-6 trial, on April 23, 2025, detailed clinical trial results of the study were presented as part of the Presidential Symposium at the European Society for Medical Oncology’s 2025 Congress (“ESMO 2025”). Additionally, positive overall survival data from the HARMONi-6 trial was presented on May 31, 2026 as a late breaking abstract for the plenary session at the ASCO 2026 Annual Meeting. The HARMONi-6 study evaluated ivonescimab in combination with platinum-based chemotherapy compared to tislelizumab (a PD-1 inhibitor) in combination with platinum-based chemotherapy in patients with previously untreated advanced NSCLC irrespective of PD-L1 expression. HARMONi-6, also referred to as AK112-306, is a single region, multi-center, double-blinded Phase III study conducted in China sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso.

Previous wording

In the HARMONi-6 planned PFS interim analysis, ivonescimab in combination with chemotherapy demonstrated a statistically significant improvement in the primary endpoint, PFS, by IRRC, when compared to tislelizumab in combination with chemotherapy, achieving a hazard ratio of 0.60 (95% CI: 0.46, 0.78; p<0.0001). A clinically meaningful benefit was demonstrated across clinical subgroups, including those with either PD-L1 negative or positive expression, as well as high-risk patients. OS data was not yet mature at the time of the data cutoff and is planned to be evaluated in the future.

Current wording

In the HARMONi-6 planned PFS interim analysis, ivonescimab in combination with chemotherapy demonstrated a statistically significant improvement in the primary endpoint, PFS, by IRRC, when compared to tislelizumab in combination with chemotherapy, achieving a hazard ratio of 0.60 (95% CI: 0.46, 0.78; p<0.0001). In the HARMONi-6 planned interim analysis of OS, ivonescimab in combination with chemotherapy demonstrated a statistically significant improvement when compared to tislelizumab in combination with chemotherapy, with a hazard ratio of 0.66 (95% CI: 0.50, 0.87; p=0.0017). For both PFS and OS, a clinically meaningful benefit was demonstrated across clinical subgroups, including those with either PD-L1 negative or positive expression.

Previous wording

Ivonescimab demonstrated an acceptable and manageable safety profile in the HARMONi-6 study, which was consistent with previous Phase III studies conducted studying ivonescimab. Nine patients (3.4%) discontinued ivonescimab plus chemotherapy due to TRAEs compared to 11 patients (4.2%) receiving tislelizumab plus chemotherapy due to TRAEs. There were eight patients in the ivonescimab plus chemotherapy arm and 10 patients in the tislelizumab plus chemotherapy arm who died as a result of TRAEs in this Phase III study. Results were published in Lancet (Chen et al. 2025).

Current wording

Ivonescimab demonstrated an acceptable and manageable safety profile in the HARMONi-6 study, which was consistent with previous Phase III studies conducted studying ivonescimab. 14 patients (5.3%) discontinued ivonescimab plus chemotherapy due to TRAEs compared to 12 patients (4.5%) receiving tislelizumab plus chemotherapy due to TRAEs. There were 10 patients in the ivonescimab plus chemotherapy arm and 11 patients in the tislelizumab plus chemotherapy arm who died as a result of TRAEs in this Phase III study. Results were published in Lancet (Lu et al. 2026).

Previous wording

The following table sets forth our results of operations for the three months ended March 31, 2026 and 2025:

Current wording

The following table sets forth our results of operations for the three and six months ended June 30, 2026 and 2025:

Previous wording

The table below summarizes our research and development expenses by category for the three months ended March 31, 2026 and 2025, respectively.

Current wording

The table below summarizes our research and development expenses by category for the three and six months ended June 30, 2026 and 2025, respectively.

Previous wording

Research and development expenses increased by $81.4 million during the three months ended March 31, 2026, compared to the same period in the prior year. The increase in third-party research and development expenses was primarily driven by a $31.5 million increase in clinical trial related expenses, a $19.9 million increase in expenses related to manufacturing and purchasing of clinical trial related materials as a result of increased enrollment in our HARMONi-3, HARMONi-7, and HARMONi-GI3 trials, and a $2.5 million increase in other external research and development expenses. The increase in internal research and development expenses was primarily driven by a $20.3 million increase in stock-based compensation expense as a result of the modification to our performance-based stock option awards during the second quarter of 2025 and a $7.2 million increase in compensation related costs, excluding stock-based compensation, as we continue to hire additional resources to support the clinical development of ivonescimab. We expect research and development expenses to continue to increase as we progress with the development of ivonescimab.

Current wording

Research and development expenses decreased $50.3 million during the three months ended June 30, 2026 and increased $31.0 million during the six months ended June 30, 2026, respectively, compared to the same periods in the prior year. The increase in third-party research and development expenses for the three and six months ended June 30, 2026, was primarily driven by a $36.9 million and $68.4 million increase in clinical trial related expenses, respectively, a $6.3 million and $26.2 million increase in expenses related to manufacturing and purchasing of clinical trial related materials as a result of increased enrollment in our HARMONi-3, HARMONi-7, and HARMONi-GI3 trials, respectively, and a $3.3 million and $5.7 million increase in other external research and development expenses, respectively. The decrease in internal research and development expenses for the three and six months ended June 30, 2026, was primarily driven by a $104.5 million and $84.2 million decrease in stock-based compensation expense respectively, as a result of the modification to our performance-based stock option awards during the second quarter of 2025, which is offset by a $7.7 million and $14.9 million increase in compensation related costs, excluding stock-based compensation, respectively, as we continue to hire additional resources to support the clinical development of ivonescimab. We expect research and development expenses to continue to increase as we progress with the development of ivonescimab.

Previous wording

The table below summarizes our general and administrative expenses by category for the three months ended March 31, 2026 and 2025, respectively.

Current wording

The table below summarizes our general and administrative expenses by category for the three and six months ended June 30, 2026 and 2025, respectively.

Previous wording

General and administrative expenses increased by $47.0 million for the three months ended March 31, 2026, compared to the same period in the prior year. The increase was primarily driven by a $41.4 million increase in stock-based compensation as a result of the modification to our performance-based stock option awards during the second quarter of 2025. In addition, compensation related costs, excluding stock-based compensation, increased by $3.4 million for the three months ended March 31, 2026 compared to the same period in the prior year as the Company is focused on building its executive management team, and legal fees and professional services increased by $1.8 million for the three months ended March 31, 2026 compared to the same period in the prior year to continue supporting the development of ivonescimab. We expect general and administrative expenses to continue to increase as we scale our infrastructure and management team to support the development of ivonescimab.

Current wording

General and administrative expenses decreased by $297.6 million and $250.6 million for the three and six months ended June 30, 2026 respectively, compared to the same periods in the prior year. The decrease was primarily driven by a $305.6 million and $264.2 million decrease in stock-based compensation respectively, as a result of the modification to our performance-based stock option awards during the second quarter of 2025. In addition, compensation related costs, excluding stock-based compensation, increased by $3.5 million and $6.9 million for the three and six months ended June 30, 2026 respectively, compared to the same periods in the prior year due to increased headcount. Additionally, legal fees and professional services increased by $3.3 million and $5.1 million for the three and six months ended June 30, 2026 respectively, compared to the same periods in the prior year to continue supporting the development of ivonescimab. We expect general and administrative expenses to continue to increase as we scale our infrastructure and increase our headcount to support the development of ivonescimab.

Previous wording

The table below summarizes our other income by category for the three months ended March 31, 2026 and 2025, respectively.

Current wording

The table below summarizes our other income by category for the three and six months ended June 30, 2026 and 2025, respectively.

Previous wording

For the three months ended March 31, 2026, other income, net increased by $1.9 million, compared to the same period in the prior year, primarily due to an increase of $2.1 million in investment income due to higher cash equivalents and short-term investments balance.

Current wording

For the three and six months ended June 30, 2026, other income, net increased by $2.1 million and $3.9 million, compared to the same periods in the prior year, primarily due to an increase of $1.4 million and $3.5 million in investment income due to higher cash equivalents and short-term investments balance, respectively.

Previous wording

During the three months ended March 31, 2026, we incurred a net loss of $189.4 million and cash flows used in operating activities for the three months ended March 31, 2026 was $122.3 million. As of March 31, 2026, we had an accumulated deficit of $2,483.6 million, and cash and cash equivalents of $106.5 million and short-term investments of $492.2 million. We expect to continue to generate operating losses for the foreseeable future.

Current wording

During the three and six months ended June 30, 2026, we incurred a net loss of $215.7 million and $405.1 million and cash flows used in operating activities for the six months ended June 30, 2026 was $263.4 million. As of June 30, 2026, we had an accumulated deficit of $2,699.3 million, cash and cash equivalents of $419.4 million and short-term investments of $271.3 million. We expect to continue to generate operating losses for the foreseeable future.

Previous wording

To date, we have financed our operations primarily through issuances of our common stock, including our most recent private placements issued in October 2025 and September 2024 for gross proceeds of $500.0 million and $235.0 million, respectively, and the raise of $150.7 million gross proceeds from our ATM Agreement since inception, issuance of debt, and receipt of payments to us under license and collaboration arrangements.

Current wording

As of June 30, 2026, we have financed our operations primarily through issuances of our common stock, including our most recent private placements issued in October 2025 and September 2024 for gross proceeds of $500.0 million and $235.0 million, respectively, and the raise of $381.6 million gross proceeds from our Distribution Agreement since inception, issuance of debt, and receipt of payments to us under license and collaboration arrangements. The remaining gross proceeds available under the Distribution Agreement as of June 30, 2026 was approximately $68.4 million which was utilized subsequent to June 30, 2026.

Previous wording

On August 11, 2025, we entered into the Amendment to the Original Distribution Agreement. Pursuant to the Amendment, the Original Distribution Agreement was amended to, among other things, increase the aggregate offering price of shares of the Company’s common stock, par value $0.01 per share, from time to time, through the sales agent, by up to an additional $360.0 million. The remaining gross proceeds available under the Distribution Agreement as of March 31, 2026 was approximately $299.3 million.

Current wording

On August 11, 2025, we entered into the Amendment to the Original Distribution Agreement. Pursuant to the Amendment, the Original Distribution Agreement was amended to, among other things, increase the aggregate offering price of shares of the Company’s common stock, par value $0.01 per share, from time to time, through the sales agent, by up to an additional $360.0 million. The remaining gross proceeds available under the Distribution Agreement as of June 30, 2026 was approximately $68.4 million which was utilized subsequent to June 30, 2026.

Previous wording

The following table summarizes our cash flows for the three months ended March 31, 2026 and 2025:

Current wording

The following table summarizes our cash flows for the six months ended June 30, 2026 and 2025:

Previous wording

Net cash used in operating activities for the three months ended March 31, 2026 was $122.3 million and primarily consisted of a net loss of $189.4 million and a $1.7 million net change in operating assets and liabilities, partially offset by non-cash charges of $68.8 million. The non-cash charges primarily consisted of $72.8 million of stock-based compensation driven by the modification to outstanding performance-based stock option awards which removed the performance-based vesting criteria, partially offset by $4.2 million relating to amortization of the discount on short-term investments in U.S. government treasury bills. The net change in operating assets and liabilities was primarily due to a $12.2 million increase in accrued liabilities and a $6.8 million increase in accounts payable, offset by a $11.0 million increase in prepaid expenses and other current assets, a $7.9 million decrease in accrued compensation, and a $1.1 million decrease in other current liabilities.

Current wording

Net cash used in operating activities for the six months ended June 30, 2026 was $263.4 million and primarily consisted of a net loss of $405.1 million and a $7.1 million net change in operating assets and liabilities, partially offset by non-cash charges of $134.6 million. The non-cash charges primarily consisted of $141.5 million of stock-based compensation driven by the modification to outstanding performance-based stock option awards which removed the performance-based vesting criteria, partially offset by $7.2 million relating to amortization of the discount on short-term investments in U.S. government treasury bills. The net change in operating assets and liabilities was primarily due to a $33.0 million increase in accrued liabilities and a $2.9 million increase in accounts payable, offset by a $23.0 million increase in prepaid expenses and other current assets, a $1.2 million increase in other assets, and a $5.5 million decrease in accrued compensation.

Previous wording

Net cash used in operating activities for the three months ended March 31, 2025 was $61.2 million and primarily consisted of the net loss of $62.9 million and a $6.2 million net change in operating assets and liabilities, partially offset by non-cash charges of $7.9 million. The non-cash charges primarily consisted of $11.1 million of stock-based compensation, partially offset by $3.0 million relating to amortization of the discount on short-term investments in U.S. government treasury bills. The net change in operating assets and liabilities was primarily due to a $7.6 million decrease in accrued compensation, a $1.4 million increase in other assets and a $1.0 million decrease in other current liabilities, partially offset by a $1.9 million decrease in prepaid expenses and other current assets and a $1.6 million increase in accrued liabilities.

Current wording

Net cash used in operating activities for the six months ended June 30, 2025 was $127.9 million and primarily consisted of a net loss of $628.6 million and a $15.2 million net change in working capital, partially offset by non-cash charges of $485.5 million. The non-cash charges primarily consisted of $489.9 million of stock-based compensation driven by the modification to outstanding performance-based stock option awards which removed the performance-based vesting criteria, partially offset by $4.0 million relating to amortization of the discount on short-term investments in U.S. Treasury securities. The net change in working capital was primarily due to a $18.3 million increase in accounts payable and a $6.5 million increase in accrued liabilities, partially offset by a $5.4 million decrease in accrued compensation and a $3.7 million increase in other assets.

Previous wording

Net cash used in investing activities for the three months ended March 31, 2026 was $0.2 million and primarily driven by $177.3 million in purchase of short-term investments and $0.2 million in purchases of property and equipment, partially offset by $177.3 million in maturities and sales of short-term investments.

Current wording

Net cash provided by investing activities for the six months ended June 30, 2026 was $222.7 million and primarily driven by $626.1 million in maturities and sales of short-term investments, offset by $402.3 million in purchase of short-term investments and $1.2 million in purchases of property and equipment.

Previous wording

Net cash provided by investing activities for the three months ended March 31, 2025 was $160.1 million and primarily driven by $160.5 million received from maturities of short-term investments in U.S. government treasury bills.

Current wording

Net cash provided by investing activities for the six months ended June 30, 2025 was $310.9 million and was primarily due to $311.3 million received from maturities of short-term investments in U.S. Treasury securities.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2026 was $3.8 million and driven by $3.8 million of proceeds received related to employee stock awards and purchase plans.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2026 was $234.9 million and was driven by $227.4 million net proceeds from our current Distribution Agreement and $7.5 million of proceeds received related to employee stock awards and purchase plans.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2025 was $7.7 million and driven by $5.7 million of proceeds received related to the exercise of warrants and $2.0 million of proceeds received related to employee stock awards and purchase plans.

Current wording

Net cash provided by financing activities was $9.9 million for the six months ended June 30, 2025, and was due to $7.3 million of proceeds received related to the exercise of warrants and $2.6 million of proceeds received related to employee stock awards and purchase plans.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

The dual primary endpoints were allocated separate alpha levels and tested individually. The alpha was recycled from the PFS to the OS analysis upon the successful achievement of the PFS endpoint.