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Nuvation Bio Inc.

For the period ended Sep 30, 2026. Filed Nov 4, 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.

Sep 30, 2026 · Filed Nov 4, 2026

NUVB$4.16-0.7%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 2026-06-30; filed 2026-08-06.

0001193125-26-336646

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

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-04.

0001193125-26-447238

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 103 previous paragraphs and 96 current paragraphs.

60 unchanged; 33 reworded; 3 added; 3 removed; 7 previous and 0 current paragraphs rearranged.

Tables are not compared: 4 previous and 4 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 (3)

Current report

In August 2026, we announced that the U.S. Food and Drug Administration (“FDA”) granted Fast Track Designation for safusidenib, the company's investigational, oral, brain-penetrant selective inhibitor of mutant IDH1.

Current report

In September 2026, we announced that the FDA approved a supplemental New Drug Application (“sNDA”) for IBTROZI® (taletrectinib). The updated IBTROZI label now reflects updated median duration of response (DOR) for the TRUST-I study, with a median DOR of 49.7 months in TKI-naïve patients in TRUST-I.

Current report

Eisai agreement, a $13.6 million increase in product supply, a $5.7 million increase in royalty revenue, and a $5.0 million increase in sales-based milestone, offset by a $4.4 million decrease in research and development service revenue under the collaboration agreements with Innovent and Nippon Kayaku.
Removed paragraphs (3)

Previous report

In April 2026, we amended the existing exclusive license agreement for safusidenib with Daiichi Sankyo to include Japan in the territory rights licensed to us, effectively securing exclusive global safusidenib development and commercialization rights for the Company.

Previous report

In May 2026, we announced the FDA had accepted a supplemental New Drug Application with updated data for IBTROZI in both TKI-naïve and TKI-pretreated advanced ROS1+ NSCLC with a target action date of January 4, 2027.

Previous report

In July 2026, we announced we will initiate two new studies to evaluate safusidenib across the broader landscape of IDH1-mutant glioma: a pivotal Phase 3 study in patients with grade 2 IDH1-mutant glioma outside the U.S, and a Phase 2 study in patients with grade 2 or 3 IDH1-mutant glioma who have progressed after prior treatment with vorasidenib in the U.S.
Reworded paragraphs (33)

Previous wording

We commercially launched IBTROZI in the U.S. in June 2025, following its approval by the FDA on June 11, 2025 for the treatment of adult patients with locally advanced or metastatic ROS1-positive (“ROS1+”) non-small cell lung cancer (“NSCLC”). Taletrectinib has also been approved by Japan’s MHLW and by China’s NMPA for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Taletrectinib is being commercialized in Japan by our partner NK under the brand name IBTROZI and in China by our partner Innovent under the brand name DOVBLERON®. Taletrectinib has been granted Orphan Drug Designation by the U.S. FDA for the treatment of patients with ROS1+ NSCLC and other NSCLC indications, and was previously granted Breakthrough Therapy Designations by both the U.S. FDA and China’s NMPA for the treatment of both TKI-naïve and TKI-pretreated patients with locally advanced or metastatic ROS1+ NSCLC. In January 2026, we announced a partnership with Eisai to commercialize taletrectinib in Europe and other territories outside the U.S., China and Japan. In March 2026, we announced that the European Medicines Agency had validated the Marketing Authorisation Application (“MAA”) for taletrectinib for the treatment of advanced ROS1+ NSCLC. In June 2026, we announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom had validated the MAA submitted by its partner Eisai for taletrectinib for the treatment of advanced ROS1+ NSCLC.

Current wording

We commercially launched IBTROZI in the U.S. in June 2025, following its approval by the FDA on June 11, 2025 for the treatment of adult patients with locally advanced or metastatic ROS1-positive (“ROS1+”) non-small cell lung cancer (“NSCLC”). Taletrectinib has also been approved by Japan’s MHLW and by China’s NMPA for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Taletrectinib is being commercialized in Japan by our partner NK under the brand name IBTROZI and in China by our partner Innovent under the brand name DOVBLERON®. Taletrectinib has been granted Orphan Drug Designation by the U.S. FDA for the treatment of patients with ROS1+ NSCLC and other NSCLC indications, and was previously granted Breakthrough Therapy Designations by both the U.S. FDA and China’s NMPA for the treatment of both TKI-naïve and TKI-pretreated patients with locally advanced or metastatic ROS1+ NSCLC. In January 2026, we announced a partnership with Eisai to commercialize taletrectinib in Europe and other territories outside the U.S., China and Japan. In March 2026, we announced that the European Medicines Agency had validated the Marketing Authorisation Application (“MAA”) for taletrectinib for the treatment of advanced ROS1+ NSCLC. In June 2026, we announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom had validated the MAA submitted by our partner Eisai for taletrectinib for the treatment of advanced ROS1+ NSCLC.

Previous wording

In addition to taletrectinib, our clinical stage pipeline includes safusidenib, a novel, oral, potent, brain penetrant, targeted inhibitor of mutant isocitrate dehydrogenase 1 (“mIDH1”). Safusidenib is being evaluated against placebo in the SIGMA study, which is a randomized Phase 3 study for the maintenance treatment of patients with IDH1-mutant astrocytoma with high-risk features.

Current wording

In addition to taletrectinib, our clinical stage pipeline includes safusidenib, an investigational, oral, brain penetrant, selective inhibitor of mutant isocitrate dehydrogenase 1 (“mIDH1”). Safusidenib is being evaluated in a pivotal Phase 3, randomized, placebo-controlled study evaluating safusidenib as maintenance therapy following standard-of-care radiotherapy or chemoradiotherapy and adjuvant temozolomide in patients with IDH1-mutant astrocytoma with high-risk features. We are also evaluating safusidenib against placebo in the Phase 3 G307 study of patients with grade 2 IDH1-mutant glioma in regions where vorasidenib is not yet approved or accessible, and in the Phase 2 G209 study in patients with grade 2 or grade 3 IDH1-mutant glioma whose cancer has progressed following treatment with vorasidenib.

Previous wording

We have incurred net losses in each year since inception. As of June 30, 2026 we had an accumulated deficit of $1,172.8 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations as well as a charge related to the acquisition of an in-process research and development asset. We expect to continue to incur significant expenses and increasing operating losses over at least the next several years. We expect our expenses will increase substantially in connection with our ongoing activities, as we:

Current wording

We have incurred net losses in each year since inception. As of September 30, 2026 we had an accumulated deficit of $1,214.7 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations as well as a charge related to the acquisition of an in-process research and development asset. We expect to continue to incur significant expenses and increasing operating losses over at least the next several years. We expect our expenses will increase substantially in connection with our ongoing activities, as we:

Previous wording

Results of Operations for The Three and Six Months Ended June 30, 2026 and 2025

Current wording

Results of Operations for The Three and Nine Months Ended September 30, 2026 and 2025

Previous wording

The following table summarizes total revenue recognized for the three and six months ended June 30, 2026 and 2025:

Current wording

The following table summarizes total revenue recognized for the three and nine months ended September 30, 2026 and 2025:

Previous wording

On June 11, 2025, we announced that the FDA approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (“NSCLC”). To date, our only source of product revenue has been from the U.S. sales of IBTROZI. We began shipping IBTROZI to our U.S. customers in June 2025. Net product revenue from U.S. sales of IBTROZI was approximately $23.2 million and $41.7 million for the three and six months ended June 30, 2026, respectively.

Current wording

On June 11, 2025, we announced that the FDA approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. To date, our only source of product revenue has been from the U.S. sales of IBTROZI. We began shipping IBTROZI to our U.S. customers in June 2025. Net product revenue from U.S. sales of IBTROZI was approximately $27.5 million and $69.2 million for the three and nine months ended September 30, 2026, respectively. Net product revenue from U.S. sales of IBTROZI was approximately $7.7 million and $9.0 million for the three and nine months ended September 30, 2025, respectively.

Previous wording

Collaboration and license agreements revenue increased by $4.9 million for the three months ended June 30, 2026 compared to 2025. The increase is primarily due to a $3.6 million increase in product supply, and a $1.8 million increase in royalty revenue, offset by a $0.5 million decrease in research and development service revenue.

Current wording

Collaboration and license agreements revenue increased by $12.1 million for the three months ended September 30, 2026 compared to 2025. The increase is due to a $7.6 million increase in product supply revenue, a $5.0 million sales-based milestone received from Innovent, and a $2.4 million increase in royalty revenue, offset by a $2.9 million decrease in research and development service revenue under the collaboration agreements with Innovent and Nippon Kayaku.

Previous wording

Collaboration and license agreements revenue increased by $66.5 million for the six months ended June 30, 2026 compared to 2025. The increase is primarily due to a $58.7 million increase in license revenue because of the upfront payment received under the Eisai agreement, a $6.0 million increase in product supply, and a $3.3 million increase in royalty revenue, offset by a $1.5 million decrease in research and development service revenue.

Current wording

Collaboration and license agreements revenue increased by $78.6 million for the nine months ended September 30, 2026 compared to 2025. The increase is primarily due to a $58.7 million increase in license revenue because of the upfront payment received under the

Previous wording

Cost of sales increased by $0.7 million for the three months ended June 30, 2026. The increase was primarily due to an increase in inventory reserve and costs incurred related to higher product revenue recognized for the three months ended June 30, 2026 compared to 2025.

Current wording

Cost of sales increased by $1.8 million for the three months ended September 30, 2026. The increase was primarily due to an increase in inventory reserve and costs incurred related to higher product revenue recognized for the three months ended September 30, 2026 compared to 2025.

Previous wording

Cost of sales increased by $1.1 million for the three months ended June 30, 2026. The increase was primarily due to an increase in inventory reserve and costs incurred related to higher product revenue recognized for the six months ended June 30, 2026 compared to 2025.

Current wording

Cost of sales increased by $2.9 million for the nine months ended September 30, 2026. The increase was primarily due to an increase in inventory reserve and costs incurred related to higher product revenue recognized for the nine months ended September 30, 2026 compared to 2025.

Previous wording

Cost of collaboration and license agreements revenue increased by $6.1 million for the three months ended June 30, 2026 compared to 2025. The increase was primarily due to a $2.4 million increase in royalty payment for Daiichi Sankyo and a $3.7 million increase in research and development service costs.

Current wording

Cost of collaboration and license agreements revenue increased by $6.8 million for the three months ended September 30, 2026 compared to 2025. The increase was primarily due to a $2.6 million increase in royalty payment to Daiichi Sankyo and a $4.2 million increase in research and development service costs.

Previous wording

Cost of collaboration and license agreements revenue increased by $9.7 million for the six months ended June 30, 2026 compared to 2025. The increase was primarily due to a $4.6 million increase in royalty payment for Daiichi Sankyo and a $5.1 million increase in research and development service costs.

Current wording

Cost of collaboration and license agreements revenue increased by $16.5 million for the nine months ended September 30, 2026 compared to 2025. The increase was primarily due to a $7.3 million increase in royalty payment to Daiichi Sankyo and a $9.2 million increase in research and development service costs.

Previous wording

Research and development expenses increased by $13.7 million for the six months ended June 30, 2026 compared to 2025. The increase was primarily due to a $0.2 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation and $13.5 million increase in third-party costs related to clinical trial expense.

Current wording

Research and development expenses increased by $3.8 million for the three months ended September 30, 2026 compared to 2025. The increase was primarily due to $3.3 million increase in third-party costs related to clinical trial expense and a $0.5 million increase in personnel costs driven by the increase in headcount and stock-based compensation.

Previous wording

Research and development expenses increased by $3.3 million for the three months ended June 30, 2026 compared to 2025. The increase was primarily due to $4.6 million increase in third-party costs related to clinical trial expense offset by a $1.3 million decrease in personnel costs as the prior period included a one-time stock-based compensation charge for performance-based awards that vested upon U.S. FDA approval of taletrectinib.

Current wording

Research and development expenses increased by $17.6 million for the nine months ended September 30, 2026 compared to 2025. The increase was primarily due to a $18.6 million increase in third-party costs related to clinical trial expense offset by a $1.0 million decrease in personnel costs as the prior period included a one-time retention bonus.

Previous wording

Selling, general and administrative expenses increased by $4.1 million for the three months ended June 30, 2026, compared to 2025. The increase was due to a $0.7 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation, $0.8 million increase in legal fees, $0.7 million increase in professional fees, $0.5 million increase in sales and marketing expenses, $0.3 million increase in foreign currency impact and a $1.1 million increase in miscellaneous expense.

Current wording

Selling, general and administrative expenses increased by $5.2 million for the three months ended September 30, 2026, compared to 2025. The increase was due to a $2.5 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation, $1.8 million increase in sales and marketing expenses and $1.6 million increase in miscellaneous expense offset by a $0.7 million decrease in legal fees.

Previous wording

Selling, general and administrative expenses increased by $7.0 million for the six months ended June 30, 2026, compared to 2025. The increase was due to a $6.4 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation, $0.1 million increase in taxes, $1.8 million increase in miscellaneous expense, $0.6 million increase in legal fees offset by a $1.2 million decrease in sales and marketing expenses, $0.2 million decrease in foreign currency impact and $0.5 million decrease in professional fees.

Current wording

Selling, general and administrative expenses increased by $12.2 million for the nine months ended September 30, 2026, compared to 2025. The increase was due to a $8.8 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation, $0.6 million increase in sales and marketing expenses and $3.3 million increase in miscellaneous expense offset by a $0.5 million decrease in professional fees.

Previous wording

Other (expense) income, net decreased by $16.4 million for the three months ended June 30, 2026 compared to 2025 primarily due to a $9.5 million loss on debt extinguishment, $6.3 million increase in interest expense primarily related to the Financing Agreement, a $0.2 million decrease in interest income from investments primarily due to lower treasury yield and a decrease of $0.5 million in change in fair value of warrant liability.

Current wording

Total other income (expense), net decreased by $0.3 million for the three months ended September 30, 2026 compared to 2025 primarily due to a decrease of $0.6 million in change in fair value of warrant liability and a $0.2 million decrease in other income related to government subsidy income offset by a $0.4 million decrease in interest expense and a $0.1 million increase in interest income from investments.

Previous wording

Other (expense) income, net decreased by $20.6 million for the six months ended June 30, 2026 compared to 2025 primarily due to a $9.5 million loss on debt extinguishment, $13.0 million increase in interest expense primarily related to the Financing Agreement, a $1.0 million decrease in other income related to government subsidy income, and a $0.4 million decrease in interest income from investments primarily due to lower treasury yield offset by an increase of $3.2 million in change in fair value of warrant liability.

Current wording

Total other income (expense), net decreased by $21.0 million for the nine months ended September 30, 2026 compared to 2025 primarily due to a $9.5 million loss on debt extinguishment, $12.6 million increase in interest expense primarily related to the Financing Agreement, a $1.2 million decrease in other income related to government subsidy income, and a $0.3 million decrease in interest income from investments primarily due to lower treasury yield offset by an increase of $2.6 million in change in fair value of warrant liability.

Previous wording

From inception through June 30, 2026, our operations have been financed primarily by the sale and issuance of Series A preferred stock and Common Stock, including through the Merger and the PIPE Investment. As of June 30, 2026, we had $661.0 million in cash, cash equivalents and marketable securities and an accumulated deficit of $1,172.8 million.

Current wording

From inception through September 30, 2026, our operations have been financed primarily by the sale and issuance of Series A preferred stock and Common Stock, including through the Merger and the Private Investment in Public Equity financing in connection with the Merger. As of September 30, 2026, we had $663.4 million in cash, cash equivalents and marketable securities and an accumulated deficit of $1,214.7 million.

Previous wording

On March 3, 2025, we announced the closing of a non-dilutive financing of up to $250.0 million from Sagard. The financing is comprised of a $150.0 million (the "Investment Amount") synthetic royalty financing agreement with Sagard Healthcare Partners (Delaware) II LP (the “RIF Agreement”) and a $100.0 million senior secured term loan with Sagard Holdings Manager LP (the “Loan Agreement”). The Investment Amount and a $50.0 million tranche of the term loan were funded in June 2025, following the FDA’s approval of IBTROZI. The second tranche of $50.0 million of the term loan was available but not borrowed. In connection with the issuance of Notes, on June 30, 2026, we used approximately $58.7 million of the net proceeds thereof to repay in full all outstanding obligations under and terminate the Loan Agreement and pay an amendment fee under the Financing Agreement. We recorded a $9.5 million loss on debt extinguishment as a result of this transaction.

Current wording

On March 3, 2025, we announced the closing of a non-dilutive financing of up to $250.0 million from Sagard. The financing is comprised of a $150.0 million (the "Investment Amount") synthetic royalty financing agreement with Sagard Healthcare Partners (Delaware) II LP (the “Financing Agreement”) and a $100.0 million senior secured term loan with Sagard Holdings Manager LP (the “Loan Agreement”). The Investment Amount and a $50.0 million tranche of the term loan were funded in June 2025, following the FDA’s approval of IBTROZI. The second tranche of $50.0 million of the term loan was available but not borrowed. In connection with the issuance of Notes, on June 30, 2026, we used approximately $58.7 million of the net proceeds thereof to repay in full all outstanding obligations under and terminate the Loan Agreement and pay an amendment fee under the Financing Agreement. We recorded a $9.5 million loss on debt extinguishment as a result of this transaction.

Previous wording

Under the RIF Agreement, in exchange for the Investment Amount, we agreed to make tiered royalty payments to Sagard on U.S. net sales of IBTROZI equal to 5.5% of annual U.S. net sales up to $600 million and 3.0% of annual U.S. net sales between $600 million and $1 billion. We retain all annual U.S. net sales above $1 billion. Our obligation to make the royalty payments will cease upon the earliest occurrence of total royalty payments reaching 1.6 times of the Investment Amount by the calendar quarter ending on June 30, 2031, 1.75 times of the Investment Amount by the calendar quarter ending on June 30, 2034, or 2.0 times of the Investment Amount thereafter. To the extent we have not made royalty payments totaling at least 100% of the Investment Amount by February 1, 2043, we will be required to make a true up payment in an amount equal to such shortfall (the “True Up Payment”). In addition, if certain events occur, including certain bankruptcy events, non-payment of Payments, a change of control, expiration or termination of certain intellectual property rights or marketing authorization, an out-license or sale of all of the rights in and to IBTROZI in the United States and (subject to applicable cure periods) non-compliance with the covenants in the RIF Agreement, we may be required to repurchase the synthetical royalty financing at a repurchase price ranging from 1.4 to 2.0 times of the Investment Amount, depending on the time of such event, less all royalty payments we made by then under the Loan Agreement, the term loan will bear interest at the secured overnight financing rate ("SOFR") plus a margin of 6.00%, subject to a 4.00% SOFR floor. There are no scheduled amortization payments associated with the term loan, with all outstanding principal due at maturity. The transaction will support the U.S. commercial launch of IBTROZI and general corporate purposes.

Current wording

Under the Financing Agreement, in exchange for the Investment Amount, we agreed to make tiered royalty payments to Sagard on U.S. net sales of IBTROZI equal to 5.5% of annual U.S. net sales up to $600 million and 3.0% of annual U.S. net sales between $600 million and $1 billion. We retain all annual U.S. net sales above $1 billion. Our obligation to make the royalty payments will cease upon the earliest occurrence of total royalty payments reaching 1.6 times the Investment Amount by the calendar quarter ending on June 30, 2031, 1.75 times the Investment Amount by the calendar quarter ending on June 30, 2034, or 2.0 times the Investment Amount thereafter. To the extent we have not made royalty payments totaling at least 100% of the Investment Amount by February 1, 2043, we will be required to make a true up payment in an amount equal to such shortfall (the “True Up Payment”). In addition, if certain events occur, including certain bankruptcy events, non-payment of Payments, a change of control, expiration or termination of certain intellectual property rights or marketing authorization, an out-license or sale of all of the rights in and to IBTROZI in the United States and (subject to applicable cure periods) non-compliance with the covenants in the Financing Agreement, we may be required to repurchase the synthetical royalty financing at a repurchase price ranging from 1.4 to 2.0 times the Investment Amount, depending on the time of such event, less all royalty payments we made by then. The transaction will support the U.S. commercial launch of IBTROZI and general corporate purposes.

Previous wording

In July 2026, we completed our registered underwritten public offering of $287.5 million aggregate principal amount of 0.75% Convertible Senior Notes due 2032 (the “Notes”), including $37.5 million aggregate principal amount of Notes issued pursuant to the exercise in full of the overallotment option granted by us to the underwriters.

Current wording

In June 2026, we completed its registered underwritten public offering of $250.0 million aggregate principal amount of 0.75% Convertible Senior Notes due 2032 (the “Notes”). The Company granted the underwriters an option, exercisable within 30 days of the offering, to purchase up to an additional $37.5 million aggregate principal amount of Notes, issued pursuant to the exercise in full of the overallotment option granted by the Company to the underwriters.

Previous wording

In June 2026, we completed our registered underwritten public offering of $250.0 million aggregate principal amount of the Notes. We granted the underwriters an option, exercisable within 30 days of the offering, to purchase up to an additional $37.5 million aggregate principal amount of Notes, issued pursuant to the exercise in full of the overallotment option granted by us to the underwriters. The Notes are general unsecured obligations of the Company and bear interest at a rate of 0.75% per year, payable semiannually in arrears on January 1 and July 1 of each year, beginning on January 1, 2027. The Notes will mature on July 1, 2032, unless earlier converted, redeemed or repurchased.

Current wording

In July 2026, we announced the full exercise of the greenshoe option in its offering of the Notes. The underwriters purchased an additional $37.5 million aggregate principal amount of notes, bringing the aggregate principal amount sold in the offering to $287.5 million, with net proceeds of approximately $279.1 million after deducting underwriting discounts and commissions, and offering expenses. The Notes are general unsecured obligations of the Company and bear interest at a rate of 0.75% per year, payable semiannually in arrears on January 1 and July 1 of each year, beginning on January 1, 2027. The Notes will mature on July 1, 2032, unless earlier converted, redeemed or repurchased.

Previous wording

The net proceeds from the Offering were approximately $279.1 million, after deducting the underwriting discounts and commissions and the estimated offering expenses payable by the Company. We used certain of the net proceeds from the Offering (i) to pay the approximately $17.1 million cost of the capped call transactions described above, and (ii) to repay in full all obligations under the Loan Agreement.

Current wording

The net proceeds from the Offering were approximately $279.1 million, after deducting the underwriting discounts and commissions, and the offering expenses payable by the Company. We used certain of the net proceeds from the Offering (i) to pay the approximately $17.1 million cost of the capped call transactions described above, and (ii) to repay in full all obligations under the Loan Agreement.

Previous wording

In connection with the issuance of the Notes, on June 24, 2026, we entered into a First Amendment to the RIF Agreement (the “RIF Amendment”), which amends the RIF Agreement to permit, among other things, the issuance of the Notes and the related capped call transactions.

Current wording

In connection with the issuance of the Notes, on June 24, 2026, we entered into a First Amendment to the Financing Agreement, which amends the Financing Agreement to permit, among other things, the issuance of the Notes and the related capped call transactions.

Previous wording

Based upon our current operating plan, we believe that our existing cash, cash equivalents and marketable securities as of June 30, 2026, will enable us to fund our operating expenses and capital expenditure requirements through at least the next 12 months.

Current wording

Based upon our current operating plan, we believe that our existing cash, cash equivalents and marketable securities as of September 30, 2026, will enable us to fund our operating expenses and capital expenditure requirements through at least the next 12 months. We believe with our cash, cash equivalents and marketable securities, together with anticipated net revenue from sales of IBTROZI, will be sufficient to fund our operating expenses for the foreseeable future.

Previous wording

In 2026, cash used in operating activities of $37.9 million was attributable to a net loss of $57.4 million, a net change of $17.1 million in our net operating assets and liabilities offset by non-cash charges of $36.1 million. The change in operating assets and liabilities was primarily due to a $11.8 million increase in accounts receivable, $8.5 million increase in inventory, $2.3 million increase in prepaid expenses and other current assets, $1.7 million decrease in contract liabilities, $0.6 million increase in interest receivable on marketable securities, $3.8 million decrease in other non-current assets, $3.1 million increase in accounts payable, and $1.4 million increase in accrued expenses. The non-cash charges consisted primarily of stock-based compensation of $19.5 million, $10.2 million in non-cash interest expense related to the Financing Agreement, $1.0 million of depreciation and amortization, $0.7 million of amortization of debt issuance costs, and $9.5 million of loss on debt extinguishment offset by changes in fair value of warrant liability of $2.9 million, amortization of premium on marketable securities of $1.6 million, $0.2 million of foreign currency transaction gain, and $0.1 million of lease expense.

Current wording

In 2026, cash used in operating activities of $76.5 million was attributable to a net loss of $99.3 million, a net change of $28.1 million in our net operating assets and liabilities offset by non-cash charges of $50.9 million. The change in operating assets and liabilities was primarily due to a $20.5 million increase in accounts receivable, $3.9 million increase in inventory, $4.2 million increase in prepaid expenses and other current assets, $3.1 million decrease in contract liabilities, and $0.4 million increase in interest receivable on marketable securities, $0.5 million increase in accounts payable, $0.1 million decrease in other non-current assets, and $3.4 million increase in accrued expenses. The non-cash charges consisted primarily of stock-based compensation of $29.6 million, $15.1 million in non-cash interest expense related to the Financing Agreement, $1.6 million of depreciation and amortization, $1.2 million of amortization of debt issuance costs, and $9.5 million of loss on debt extinguishment offset by changes in fair value of warrant liability of $2.9 million, amortization of premium on marketable securities of $2.7 million, and $0.5 million of foreign currency transaction gain.

Previous wording

liabilities was primarily due to a $10.0 million decrease in accounts receivable, $16.1 million increase in accounts payable, $8.0 million increase in intangible assets, $0.1 million decrease in other non-current assets, $8.8 million decrease in accrued expenses, $4.5 million decrease in contract liabilities, $1.0 million increase in prepaid expenses and other current assets, $0.6 million increase in inventory $0.4 million increase in interest receivable on marketable securities. The non-cash charges consisted primarily of stock-based compensation of $19.9 million, changes in fair value of warrant liability of $0.3 million, $0.7 million of depreciation and amortization, $0.3 million of lease expense, $0.3 million in interest expense offset by amortization of premium on marketable securities of $2.8 million and $0.2 million of foreign currency transaction gain.

Current wording

In 2025, cash used in operating activities of $143.7 million was attributable to a net loss of $168.0 million, net change of $5.7 million in our net operating assets and liabilities offset by non-cash charges of $30.0 million. The change in operating assets and liabilities was primarily due to a $4.4 million decrease in accounts receivable, $9.0 million increase in accounts payable, $0.7 million increase in other non-current assets, $0.3 million decrease in accrued expenses, $8.8 million decrease in contract liabilities, $1.7 million increase in prepaid expenses and other current assets, $5.7 million increase in inventory, and $2.0 million increase in interest receivable on marketable securities. The non-cash charges consisted primarily of stock-based compensation of $27.9 million, $1.2 million of depreciation and amortization, $0.3 million of lease expense, $5.1 million in interest expense, $0.3 million of amortization of debt issuance costs offset by amortization of premium on marketable securities of $4.1 million, changes in fair value of warrant liability of $0.3 million and $0.4 million of foreign currency transaction gain.

Previous wording

In 2026, cash used in investing activities of $37.6 million was related to the purchase of marketable securities of $149.8 million, $0.3 million purchase of property and equipment offset by $112.5 million of proceeds from the sale of marketable securities.

Current wording

In 2026, cash used in investing activities of $147.0 million was related to the purchase of marketable securities of $375.7 million, $1.9 million purchase of property and equipment offset by $230.6 million of proceeds from the sale of marketable securities.

Previous wording

In 2025, cash provided by investing activities of $109.1 million was related to the $251.7 million of proceeds from the sale of

Current wording

In 2025, cash provided by investing activities of $12.4 million was related to the $330.2 million of proceeds from the sale of marketable securities offset by purchase of marketable securities of $309.5 million, $8.0 million payment for capitalized market approval intangibles and $0.3 million purchase of property and equipment.

Previous wording

In 2026, cash provided by financing activities of $170.6 million was related to the $243.7 million proceeds from convertible debt, $4.4 million proceeds from exercise of options, $1.2 million proceeds from issuance of Class A Common Stock under the Employee Stock Purchase Plan offset by $58.7 million to repay in full all outstanding obligations under and terminate the Loan Agreement and pay an amendment fee under the Financing Agreement, $17.1 million of capped call transactions, $1.9 million payments on Financing Agreement, and $1.1 million payment of debt issuance costs.

Current wording

In 2026, cash provided by financing activities of $213.7 million was related to the $280.3 million proceeds from convertible debt, $12.4 million proceeds from exercise of options, $1.2 million proceeds from issuance of Class A Common Stock under the Employee Stock Purchase Plan offset by $58.7 million to repay in full all outstanding obligations under and terminate the Loan Agreement and pay an amendment fee under the Financing Agreement, $17.1 million of capped call transactions, $3.2 million payments for the Financing Agreement, and $1.2 million payment of debt issuance costs.

Previous wording

In 2025, cash provided by financing activities of $194.0 million was related to the $150.0 million proceeds from the RIF

Current wording

In 2025, cash provided by financing activities of $194.5 million was related to the $150.0 million proceeds from the Financing Agreement, $48.9 million proceeds from the Loan Agreement, $2.4 million proceeds from exercise of options and $0.5 million of proceeds from issuance of Class A Common Stock under the Employee Stock Purchase Plan offset by $6.5 million payment of debt issuance costs, $0.7 million of debt repayments, and $0.1 million payment for Financing Agreement.

Previous wording

For information about recent accounting pronouncements, see the sections titled “Significant Accounting Policies—Recent Accounting Pronouncements” in Note 2 to our consolidated financial statements for the three months ended June 30, 2026 appearing elsewhere in this report.

Current wording

For information about recent accounting pronouncements, see the sections titled “Significant Accounting Policies—Recent Accounting Pronouncements” in Note 2 to our consolidated financial statements for the three and nine months ended September 30, 2026 appearing elsewhere in this report.
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Previous report — wording carried elsewhere

In June 2026, we announced that the MHRA in the United Kingdom had validated the Marketing Authorisation Application submitted by our partner Eisai for taletrectinib for the treatment of advanced ROS1+ NSCLC.

Previous report — wording carried elsewhere

We believe with our cash, cash equivalents and marketable securities, together with anticipated net revenue from sales of IBTROZI, will be sufficient to fund our operating expenses for the foreseeable future.

Previous report — wording carried elsewhere

In 2025, cash used in operating activities of $90.8 million was attributable to a net loss of $112.2 million offset by a net change

Previous report — wording carried elsewhere

of $2.9 million in our net operating assets and liabilities and non-cash charges of $18.5 million. The change in operating assets and

Previous report — wording carried elsewhere

marketable securities offset by purchase of marketable securities of $142.4 million and $0.2 million purchase of property and equipment.

Previous report — wording carried elsewhere

Agreement, $48.9 million proceeds from the Loan Agreement, $1.9 million proceeds from exercise of options and $0.5 million of

Previous report — wording carried elsewhere

proceeds from issuance of Class A Common Stock under the Employee Stock Purchase Plan offset by $6.6 million payment of debt issuance costs and $0.7 million of debt repayments.