Cogent Biosciences, Inc.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
View on SEC.govAbout 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.
Sep 30, 2026 · Filed Nov 5, 2026
COGT$31.65+7.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-10.
0001193125-26-342393
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-05.
0001193125-26-449963
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 137 previous paragraphs and 137 current paragraphs.
102 unchanged; 31 reworded; 4 added; 4 removed; 0 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 (4)
Current report
During the second quarter of 2026, we initiated a single-arm, 40 patient extension cohort of the PEAK trial investigating the safety and efficacy of bezuclastinib in combination with sunitinib in first-line GIST patients. This cohort is designed to prospectively measure overall response rate and PFS in patients with either exon 9 or exon 11 primary mutations.
Current report
As of September 30, 2026, we had cash, cash equivalents and marketable securities of $791.1 million. We believe that our cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into late 2028, well past all three pending PDUFA action dates for bezuclastinib.
Current report
Comparison of the Nine Months Ended September 30, 2026 and 2025
Current report
As of September 30, 2026, we had cash, cash equivalents and marketable securities of $791.1 million. We believe that our cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into late 2028, well past all three pending PDUFA action dates or bezuclastinib.
Removed paragraphs (4)
Previous report
During the second quarter of 2026, we initiated a Phase 2 trial investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib.
Previous report
As of June 30, 2026, we had cash, cash equivalents and marketable securities of $792.3 million. We believe that our cash, cash equivalents and marketable securities, with the $71.4 million net proceeds from shares sold under our ATM after the end of the quarter, will be sufficient to fund our operating expenses and capital expenditure requirements into late 2028, including through potential FDA approval of bezuclastinib and commercial launch for SM and GIST.
Previous report
Comparison of the Six Months Ended June 30, 2026 and 2025
Previous report
As of June 30, 2026, we had cash, cash equivalents and marketable securities of $792.3 million. We believe that our cash, cash equivalents and marketable securities, with the $71.4 million net proceeds from shares sold under our ATM after the end of the quarter, will be sufficient to fund our operating expenses and capital expenditure requirements into late 2028, including through potential FDA approval of bezuclastinib and commercial launch for SM and GIST.
Reworded paragraphs (31)
Previous wording
SUMMIT is our registration-directed randomized, global, multicenter, double-blind, placebo-controlled, multi-part Phase 2 clinical trial for patients with NonAdvSM. The study is designed to explore the safety and efficacy of bezuclastinib in patients with moderate to severe NonAdvSM, which includes Indolent Systemic Mastocytosis (“ISM”), Smoldering Systemic Mastocytosis (“SSM”) and Bone Marrow Mastocytosis. APEX is our registration-directed global, open-label, multi-center, Phase 2 clinical trial in patients with AdvSM evaluating the safety, efficacy, pharmacokinetic, and pharmacodynamic profiles of bezuclastinib. We reported top-line results from our SUMMIT trial in July 2025 and full results in December 2025, as well as top-line results from our APEX trial in December 2025 and full results in June 2026, all of which were positive and achieved all primary and key secondary endpoints.
Current wording
SUMMIT is our registration-directed randomized, global, multi-center, double-blind, placebo-controlled, multi-part Phase 2 clinical trial for patients with NonAdvSM. The study is designed to explore the safety and efficacy of bezuclastinib in patients with moderate to severe NonAdvSM, which includes Indolent Systemic Mastocytosis (“ISM”), Smoldering Systemic Mastocytosis (“SSM”) and Bone Marrow Mastocytosis. APEX is our registration-directed global, open-label, multi-center, Phase 2 clinical trial in patients with AdvSM evaluating the safety, efficacy, pharmacokinetic, and pharmacodynamic profiles of bezuclastinib. We reported top-line results from our SUMMIT trial in July 2025 and full results in December 2025, as well as top-line results from our APEX trial in December 2025 and full results in June 2026, all of which were positive and achieved all primary and key secondary endpoints.
Previous wording
We submitted the first NDA for bezuclastinib in patients with NonAdvSM in December 2025, which was accepted by the FDA in March 2026. The FDA assigned a Prescription Drug User Fee Act ("PDUFA") target action date of December 30, 2026. We submitted an NDA in June 2026 for patients with AdvSM. In October 2025, the FDA granted Breakthrough Therapy Designation for bezuclastinib in NonAdvSM patients previously treated with avapritinib as well as in patients with SSM, both patient populations with no currently approved standard of care. The FDA and European Medicines Agency (“EMA”) have granted orphan drug designation to bezuclastinib for the treatment of Mastocytosis.
Current wording
We submitted the first NDA for bezuclastinib in patients with NonAdvSM in December 2025, which was accepted by the FDA in March 2026. The FDA assigned a Prescription Drug User Fee Act ("PDUFA") target action date of December 30, 2026. We submitted an NDA in June 2026 for patients with AdvSM, which was accepted by the FDA in September 2026. The FDA assigned a PDUFA target action date of June 29, 2027. In October 2025, the FDA granted Breakthrough Therapy Designation (“BTD”) for bezuclastinib in NonAdvSM patients previously treated with avapritinib as well as in patients with SSM, both patient populations with no currently approved standard of care. The FDA and European Medicines Agency (“EMA”) have granted orphan drug designation to bezuclastinib for the treatment of Mastocytosis.
Previous wording
PEAK is our randomized open-label, global Phase 3 clinical trial designed to evaluate the safety, tolerability, and efficacy of bezuclastinib in combination with sunitinib compared to sunitinib alone in patients with locally advanced, unresectable or metastatic GIST who have received prior treatment with imatinib. We reported top-line results from our PEAK trial in November 2025 and full results in May 2026, which demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of progression free survival (“PFS”). Median PFS was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy, and the bezuclastinib combination reduced the risk of disease progression or death by 50% compared to sunitinib monotherapy. In January 2026, we announced that the FDA agreed to accept our NDA for bezuclastinib in combination with sunitinib for patients with GIST who have received prior treatment with imatinib under the Real-Time Oncology Review (“RTOR”) program and we submitted our GIST NDA in March 2026 under this program, which was accepted by the FDA with Priority Review in May 2026. The FDA assigned a PDUFA target action date of November 30, 2026. In January 2026, the FDA also granted Breakthrough Therapy Designation (“BTD”) for bezuclastinib in combination with sunitinib for patients with GIST who have received prior treatment with imatinib. Bezuclastinib has been granted orphan drug designation for the treatment of GIST by the FDA under the Orphan Drug Act and by the EMA.
Current wording
PEAK is our randomized open-label, global Phase 3 clinical trial designed to evaluate the safety, tolerability, and efficacy of bezuclastinib in combination with sunitinib compared to sunitinib alone in patients with locally advanced, unresectable or metastatic GIST who have received prior treatment with imatinib. We reported top-line results from our PEAK trial in November 2025 and full results in May 2026, which demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of progression free survival (“PFS”). Median PFS was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy, and the bezuclastinib combination reduced the risk of disease progression or death by 50% compared to sunitinib monotherapy. In January 2026, we announced that the FDA agreed to accept our NDA for bezuclastinib in combination with sunitinib for patients with GIST who have received prior treatment with imatinib under the Real-Time Oncology Review (“RTOR”) program and we submitted our GIST NDA in March 2026 under this program, which was accepted by the FDA with Priority Review in May 2026. The FDA assigned a PDUFA target action date of November 30, 2026. In January 2026, the FDA also granted BTD for bezuclastinib in combination with sunitinib for patients with GIST who have received prior treatment with imatinib. Bezuclastinib has been granted orphan drug designation for the treatment of GIST by the FDA under the Orphan Drug Act and by the EMA.
Previous wording
We are also advancing a novel, ErbB2 mutant program, which is focused on actionable and underserved mutations in a variety of solid tumor systemic and CNS involved indications. HER2 alterations such as amplification, overexpression, insertions, and point mutations, are established oncogenic drivers in many solid tumors. Activating HER2 mutations are found in 2-4% of advanced lung cancers and have emerged as mechanisms of acquired resistance to targeted therapies. Patients with HER2 mutant lung tumors develop more brain metastasis during treatment than patients with any other oncogenic drivers in lung cancer. Addressing brain metastasis in this group of patients remains a clinical challenge with limited therapeutic options. Approved HER2 tyrosine kinase inhibitors have inferior potency against key mutations and lack sufficient brain penetration to be an impactful treatment option for patients with brain metastasis. We received clearance from the FDA on our investigational new drug application (“IND”) submission for CGT4255 and have an ongoing Phase 1 dose escalation study.
Current wording
We are also advancing a novel, ErbB2 mutant program, which is focused on actionable and underserved mutations in a variety of solid tumor systemic and CNS involved indications. HER2 alterations such as amplification, overexpression, insertions, and point mutations, are established oncogenic drivers in many solid tumors. Activating HER2 mutations are found in 2-4% of advanced lung cancers and have emerged as mechanisms of acquired resistance to targeted therapies. Patients with HER2 mutant lung tumors develop more brain metastasis during treatment than patients with any other oncogenic drivers in lung cancer. Addressing brain metastasis in this group of patients remains a clinical challenge with limited therapeutic options. Approved HER2 tyrosine kinase inhibitors have inferior potency against key mutations and lack sufficient brain penetration to be an impactful treatment option for patients with brain metastasis. We have an ongoing Phase 1 dose escalation study for CGT4255.
Previous wording
Our research team is developing a potential best-in-class, wild-type-sparing, PI3Kα inhibitor that provides coverage of both the H1047R mutation as well as E542K and E545K helical mutants, which affects >30,000 cancer patients each year. The phosphoinositide 3-kinase (“PI3K”) pathway is a key cell cycle regulating pathway that has an established role in tumor growth and development. PI3Kα mutations are highly prevalent in many solid tumors and are present in 36% of all breast cancer patients. The approved agents for these patients often lead to dose limitations, resulting from activity against wild-type PI3Kα. IND-enabling studies have been completed for CGT6297 and we submitted an IND application for this program in the fourth quarter of 2025. We have an ongoing Phase 1 dose escalation study.
Current wording
Our research team is developing a potential best-in-class, wild-type-sparing, PI3Kα inhibitor that provides coverage of both the H1047R mutation as well as E542K and E545K helical mutants, which affects >30,000 cancer patients each year. The phosphoinositide 3-kinase (“PI3K”) pathway is a key cell cycle regulating pathway that has an established role in tumor growth and development. PI3Kα mutations are highly prevalent in many solid tumors and are present in 36% of all breast cancer patients. The approved agents for these patients often lead to dose limitations, resulting from activity against wild-type PI3Kα. We have an ongoing Phase 1 dose escalation study for CGT6297.
Previous wording
Since our inception in 2014, we have focused significant efforts and financial resources on establishing and protecting our intellectual property portfolio, conducting research and development of our product candidates, manufacturing drug product material for use in preclinical studies and clinical trials, staffing our company, and raising capital. We do not have any products approved for sale and have not generated any revenue from product sales. Our net loss was $193.8 million for the six months ended June 30, 2026 compared to net loss of $145.5 million for the six months ended June 30, 2025. As of June 30, 2026, we had an accumulated deficit of $1,382.2 million. We expect to continue to incur significant expenses and operating losses for at least the next several years. We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:
Current wording
Since our inception in 2014, we have focused significant efforts and financial resources on establishing and protecting our intellectual property portfolio, conducting research and development of our product candidates, manufacturing drug product material for use in preclinical studies and clinical trials, staffing our company, and raising capital. We do not have any products approved for sale and have not generated any revenue from product sales. Our net loss was $305.2 million for the nine months ended September 30, 2026 compared to net loss of $226.4 million for the nine months ended September 30, 2025. As of September 30, 2026, we had an accumulated deficit of $1,493.6 million. We expect to continue to incur significant expenses and operating losses for at least the next several years. We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:
Previous wording
Interest expense consists of interest incurred on the Notes and the Credit Facility (as defined below) and associated amortization of issuance costs and the accretion of debt discount.
Current wording
Interest expense consists of interest incurred on the Notes and the Credit Facility (each as defined in Note 8 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q) and the associated amortization of issuance costs and the accretion of debt discount.
Previous wording
Other income (expense), net consists of miscellaneous income and expense unrelated to our core operations.
Current wording
Other expense, net consists of miscellaneous income and expense unrelated to our core operations.
Previous wording
Total research and development expense increased by $8.6 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily driven by costs to support the SUMMIT, PEAK and APEX clinical programs, regulatory activities associated with potential approvals of bezuclastinib, continued investment in the company's early-stage research pipeline, and pre-approval manufacturing costs that would otherwise be capitalized following anticipated FDA approval. The change also includes an increase in stock-based compensation expense of $3.6 million for the three months ended June 30, 2026 as compared to the three months ended June 30, 2025.
Current wording
Total research and development expense increased by $6.1 million for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. The increase was primarily driven by costs to support the SUMMIT, PEAK and APEX clinical programs, regulatory activities associated with potential approvals of bezuclastinib, continued investment in the company's early-stage research pipeline, and pre-launch inventory. The change also includes an increase in stock-based compensation expense of $2.1 million for the three months ended September 30, 2026 as compared to the three months ended September 30, 2025.
Previous wording
General and administrative expenses for the three months ended June 30, 2026 were $31.8 million, compared to $13.4 million for the three months ended June 30, 2025. The increase in general and administrative expenses was driven by continued investments in commercial readiness, including personnel and infrastructure to support the potential launch of bezuclastinib, as well as overall organizational growth.
Current wording
General and administrative expenses for the three months ended September 30, 2026 were $42.1 million, compared to $14.4 million for the three months ended September 30, 2025. The increase in general and administrative expenses was driven by continued investments in commercial readiness, including personnel and infrastructure to support the potential launch of bezuclastinib, as well as overall organizational growth. The change also includes an increase in stock-based compensation expense of $4.2 million for the three months ended September 30, 2026 as compared to the three months ended September 30, 2025.
Previous wording
Interest income for the three months ended June 30, 2026 was $7.5 million, compared to $2.4 million for the three months ended June 30, 2025. The increase is due to higher invested balances in cash equivalents and marketable securities.
Current wording
Interest income for the three months ended September 30, 2026 was $7.1 million, compared to $3.9 million for the three months ended September 30, 2025. The increase is due to higher invested balances in cash equivalents and marketable securities.
Previous wording
Interest expense for the three months ended June 30, 2026 was $1.2 million related to the Notes and associated amortization of financing costs and the accretion of debt discount. Interest expense for the three months ended June 30, 2025 was $0.3 million related to the Credit Facility and associated amortization of financing costs and the accretion of debt discount.
Current wording
Interest expense for the three months ended September 30, 2026 was $1.2 million related to the Notes and associated amortization of issuance costs and the accretion of debt discount. Interest expense for the three months ended September 30, 2025 was $1.5 million related to the Credit Facility and associated amortization of financing costs and the accretion of debt discount.
Previous wording
Other income (expense), net for the three months ended June 30, 2026 and 2025 was not material and represented miscellaneous expense.
Current wording
Other expense, net for the three months ended September 30, 2026 and 2025 was not material and represented miscellaneous expense.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2026 and 2025:
Previous wording
The following table summarizes our research and development expenses for the six months ended June 30, 2026 and 2025:
Current wording
The following table summarizes our research and development expenses for the nine months ended September 30, 2026 and 2025:
Previous wording
Total research and development expense increased by $20.9 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily driven by costs to support the SUMMIT, PEAK and APEX clinical programs, regulatory activities associated with potential approvals of bezuclastinib, continued investment in the company's early-stage research pipeline, and pre-approval manufacturing costs that would otherwise be capitalized following anticipated FDA approval. The change also includes an increase in stock-based compensation expense of $7.3 million for the six months ended June 30, 2026 as compared to the six months ended June 30, 2025.
Current wording
Total research and development expense increased by $27.1 million for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. The increase was primarily driven by costs to support the SUMMIT, PEAK and APEX clinical programs, regulatory activities associated with potential approvals of bezuclastinib, continued investment in the company's early-stage research pipeline, and pre-launch inventory. The change also includes an increase in stock-based compensation expense of $9.4 million for the nine months ended September 30, 2026 as compared to the nine months ended September 30, 2025.
Previous wording
General and administrative expenses for the six months ended June 30, 2026 were $60.1 million, compared to $25.3 million for the six months ended June 30, 2025. The increase in general and administrative expenses was driven by continued investments in commercial readiness, including personnel and infrastructure to support the potential launch of bezuclastinib, as well as overall organizational growth.
Current wording
General and administrative expenses for the nine months ended September 30, 2026 were $102.2 million, compared to $39.6 million for the nine months ended September 30, 2025. The increase in general and administrative expenses was driven by continued investments in commercial readiness, including personnel and infrastructure to support the potential launch of bezuclastinib, as well as overall organizational growth. The change also includes an increase in stock-based compensation expense of $11.1 million for the nine months ended September 30, 2026 as compared to the nine months ended September 30, 2025.
Previous wording
Interest income for the six months ended June 30, 2026 was $15.1 million, compared to $5.3 million for the six months ended June 30, 2025. The increase is due to higher invested balances in cash equivalents and marketable securities.
Current wording
Interest income for the nine months ended September 30, 2026 was $22.1 million, compared to $9.2 million for the nine months ended September 30, 2025. The increase is due to higher invested balances in cash equivalents and marketable securities.
Previous wording
Interest expense for the six months ended June 30, 2026 was $2.4 million related to the Notes and associated amortization of issuance costs and the accretion of debt discount. Interest expense for the six months ended June 30, 2025 was $0.3 million related to the Credit Facility and associated amortization of financing costs and the accretion of debt discount.
Current wording
Interest expense for the nine months ended September 30, 2026 was $3.7 million related to the Notes and associated amortization of issuance costs and the accretion of debt discount. Interest expense for the nine months ended September 30, 2025 was $1.8 million related to the Credit Facility and associated amortization of financing costs and the accretion of debt discount.
Previous wording
Other income (expense), net for the six months ended June 30, 2026 and 2025 was not material and represented miscellaneous expense.
Current wording
Other expense, net for the nine months ended September 30, 2026 and 2025 was not material and represented miscellaneous expense.
Previous wording
As of June 30, 2026, we have 185,967,909 shares outstanding on an as-converted basis, which consists of (i) 171,598,409 shares of common stock outstanding, (ii) 39,414 shares of Series A Non-Voting Convertible Preferred Stock that are convertible into 9,853,500 shares of common stock and (iii) 4,516 shares of Series B Non-Voting Convertible Preferred Stock that are convertible into 4,516,000 shares of common stock.
Current wording
As of September 30, 2026, we had 188,353,219 shares outstanding on an as-converted basis, which consists of (i) 173,983,719 shares of common stock outstanding, (ii) 39,414 shares of Series A Non-Voting Convertible Preferred Stock that are convertible into 9,853,500 shares of common stock and (iii) 4,516 shares of Series B Non-Voting Convertible Preferred Stock that are convertible into 4,516,000 shares of common stock.
Previous wording
On May 6, 2022, we entered into a Sales Agreement (the “Sales Agreement”) with Guggenheim Securities, LLC (“Guggenheim Securities”), pursuant to which we may issue and sell, from time to time, shares of our common stock having an aggregate offering price of up to $75.0 million through Guggenheim Securities, as the sales agent, in an at the market offering (“ATM”) registered under a shelf registration statement on Form S-3. On November 7, 2025, we amended the Sales Agreement to increase the aggregate offering price to up to $300.0 million. No shares were sold under the Sales Agreement during the three months ended June 30, 2026. During the six months ended June 30, 2026, 1,340,699 shares were sold under the Sales Agreement for net proceeds of approximately $45.7 million. As of June 30, 2026, $88.6 million remained unsold and available for sale under the Sales Agreement. Subsequent to June 30, 2026, 1,743,528 shares of common stock were sold under the Sales Agreement for net proceeds of approximately $71.4 million.
Current wording
On May 6, 2022, we entered into a Sales Agreement with Guggenheim Securities, LLC (“Guggenheim Securities”), as amended by that certain Amendment No. 1 to Sales Agreement, dated November 7, 2025 (as amended, the “Sales Agreement”) pursuant to which we may issue and sell, from time to time, shares of our common stock through Guggenheim Securities, as the sales agent, in an at the market offering (“ATM”) registered under a shelf registration statement on Form S-3. On August 10, 2026, we filed a prospectus supplement pursuant to Rule 424(b) under the Securities Act with the SEC relating to the offer and sale of up to an additional $400.0 million of shares of common stock under the Sales Agreement, in addition to the $300.0 million of shares of common stock covered by the prospectus supplement filed on November 7, 2025. During the nine months ended September 30, 2026, 3,094,902 shares were sold under the Sales Agreement for net proceeds of approximately $117.5 million. As of September 30, 2026, $414.6 million remained unsold and available for sale under the Sales Agreement.
Previous wording
Net cash used in operating activities was $164.2 million during the six months ended June 30, 2026 and primarily consisted of a net loss of $193.8 million, adjusted for changes in our net working capital and other non-cash items, including stock-based compensation of $34.0 million.
Current wording
Net cash used in operating activities was $244.9 million during the nine months ended September 30, 2026 and primarily consisted of a net loss of $305.2 million, adjusted for changes in our net working capital and other non-cash items, including stock-based compensation of $50.9 million.
Previous wording
Net cash used in operating activities was $121.1 million during the six months ended June 30, 2025 and primarily resulted from our net loss of $145.5 million, adjusted for changes in our net working capital and other non-cash items, including stock-based compensation of $19.7 million.
Current wording
Net cash used in operating activities was $185.3 million during the nine months ended September 30, 2025 and primarily consisted of a net loss of $226.4 million, adjusted for changes in our net working capital and other non-cash items, including stock-based compensation of $30.3 million.
Previous wording
During the six months ended June 30, 2025, net cash provided by investing activities was $78.3 million which consisted of maturities and sales of marketable securities, partially offset by purchases of property and equipment and marketable securities.
Current wording
During the nine months ended September 30, 2026, net cash provided by investing activities was $15.1 million, which consisted of maturities and sales of marketable securities, partially offset by purchases of marketable securities and property and equipment.
Previous wording
During the six months ended June 30, 2026, net cash used in investing activities was $22.2 million, which consisted of purchases of marketable securities and property and equipment, partially offset by maturities and sales of marketable securities.
Current wording
During the nine months ended September 30, 2025, net cash used in investing activities was $76.8 million which consisted of purchases of marketable securities and property and equipment, partially offset by maturities and sales of marketable securities.
Previous wording
During the six months ended June 30, 2026, net cash provided by financing activities was $55.5 million, which consisted of $45.7 million in proceeds from the issuance of common stock under the ATM, net of paid issuance costs, proceeds from the issuance of common stock upon stock option exercises, and proceeds from the issuance of common stock under the Employee Stock Purchase Plan.
Current wording
During the nine months ended September 30, 2026, net cash provided by financing activities was $135.3 million, which consisted of $117.5 million in proceeds from the issuance of common stock under the ATM, net of paid issuance costs, proceeds from the issuance of common stock upon stock option exercises, and proceeds from the issuance of common stock under the Employee Stock Purchase Plan.
Previous wording
During the six months ended June 30, 2025, net cash provided by financing activities was $72.2 million, which consisted of $47.2 million in proceeds from the Credit Facility, net of paid issuance costs, $24.3 million in proceeds from the issuance of common stock under the ATM, net of paid issuance costs, proceeds from the issuance of common stock under the 2018 Employee Stock Purchase Plan and proceeds from the issuance of common stock upon stock option exercises.
Current wording
During the nine months ended September 30, 2025, net cash provided by financing activities was $289.6 million, which consisted of $215.8 million in proceeds from the issuance of common stock in a public offering, net of paid offering costs, $47.0 million in proceeds from the Credit Facility, net of paid issuance costs, $24.3 million in proceeds from the issuance of common stock under the ATM, net of paid issuance costs, proceeds from the issuance of common stock under the Employee Stock Purchase Plan and proceeds from the issuance of common stock upon stock option exercises.
Previous wording
As of June 30, 2026, we had cash, cash equivalents and marketable securities of $792.3 million. We believe that our cash, cash equivalents and marketable securities, with the $71.4 million net proceeds from shares sold under our ATM after the end of the quarter, will be sufficient to fund our operating expenses and capital expenditure requirements into late 2028, including through potential FDA approval of bezuclastinib and commercial launch for SM and GIST. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
Current wording
As of September 30, 2026, we had cash, cash equivalents and marketable securities of $791.1 million. We believe that our cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into late 2028, well past all three pending PDUFA action dates for bezuclastinib. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
Previous wording
There have been no material changes in our critical accounting policies during the six months ended June 30, 2026, as compared to those described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates” in our Annual Report on Form 10-K.
Current wording
There have been no material changes in our critical accounting policies during the nine months ended September 30, 2026, as compared to those described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates” in our Annual Report on Form 10-K.
Previous wording
A description of our material cash requirements, including commitments for capital expenditures, is described above and disclosed in Note 7 and Note 8 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
Current wording
A description of our material cash requirements, including commitments for capital expenditures, is described above and disclosed in Note 7 and Note 8 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. These include approximately $108.5 million of non-cancelable minimum purchase commitments as of September 30, 2026 under our agreements with contract manufacturing organizations, including the Commercial Supply Agreement we entered into with Hovione FarmaCiencia S.A. in September 2026 for the commercial supply of bezuclastinib, which has an initial five-year term and requires us to purchase specified minimum percentages of our requirements from Hovione.