Nuvation Bio Inc.

Previous wording

We commercially launched IBTROZI in the U.S. in June 2025, following its approval by the U.S. Food and Drug Administration (“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 Ministry of Health, Labour, and Welfare (“MHLW”) and by China’s National Medical Products Administration (“NMPA”) for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Taletrectinib is being commercialized in Japan by our partner Nippon Kayaku Co., Ltd under the brand name IBTROZI and in China by our partner Innovent Biologics (Suzhou) Co. Ltd. (“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 National Medical Products Administration (“NMPA”) for the treatment of patients with locally advanced or metastatic 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 disease patients with locally advanced or metastatic ROS1+ NSCLC. In January 2026, we announced a partnership with Eisai Co., Ltd. (“Eisai”) to commercialize taletrectinib in Europe and other territories outside the U.S., China and Japan. In March 2026, we announced that the

Previous wording

Taletrectinib continues to be evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I in China, and TRUST-II, a global study, as well as in a confirmatory randomized Phase 3 study versus crizotinib in China known as TRUST-III. Taletrectinib is also being evaluated for the adjuvant treatment of patients with resected ROS1+ early-stage NSCLC in a global Phase 3, placebo-controlled study known as TRUST-IV.

Current wording

Taletrectinib continues to be evaluated for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I in China, and TRUST-II, a global study, as well as in a confirmatory randomized Phase 3 study versus crizotinib in China known as TRUST-III. Taletrectinib is also being evaluated for the adjuvant treatment of patients with resected ROS1+ early-stage NSCLC in a global Phase 3, placebo-controlled study known as TRUST-IV.

Previous wording

Safusidenib is a novel, oral, potent, brain penetrant, targeted inhibitor of mutant isocitrate dehydrogenase 1 ("mIDH1"). Safusidenib is being evaluated in the G203 study, which is currently a randomized phase 2 study for the maintenance treatment of high grade IDH1-mutant glioma with safusidenib against placebo. Following alignment with FDA, a protocol amendment is in progress to finalize G203 as a global Phase 3 study by increasing the study size to support potential regulatory approvals.

Current 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.

Previous wording

Since our inception in 2018, we have focused substantially all of our resources on conducting research and development activities, including drug discovery, preclinical studies, clinical trials, establishing and maintaining our intellectual property portfolio, developing our manufacturing network and managing the manufacture of clinical and research material, hiring personnel, raising capital and providing general and administrative support for these operations. Our revenue related to its out-licensing collaborative agreements consists of product revenue, upfront license fees, royalty revenue and research and development services revenue from its collaboration agreements. We have funded our operations to date primarily from the issuance and sale of our common and preferred stock, including through the Merger and a Private Investment in Public Equity ("PIPE") financing in connection with the Merger.

Current wording

Since our inception in 2018, we have focused substantially all of our resources on conducting research and development activities, including drug discovery, preclinical studies, clinical trials, establishing and maintaining our intellectual property portfolio, developing our manufacturing network and managing the manufacture of clinical and research material, hiring personnel, raising capital and providing general and administrative support for these operations. Our revenue related to its out-licensing collaborative agreements consists of product revenue, upfront license fees and milestone payments, royalty revenue and research and development services revenue from its collaboration agreements. We have funded our operations to date primarily from the issuance and sale of our common and preferred stock, including through the Merger and a Private Investment in Public Equity ("PIPE") financing in connection with the Merger.

Previous wording

We have incurred net losses in each year since inception. As of September 30, 2025, we had an accumulated deficit of $1,078.8 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 March 31, 2026 we had an accumulated deficit of $1,110.0 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

Prior to our commercialization of IBTROZI, substantially all of our revenues were generated from payments under prior collaboration agreements, and milestones, royalties and other revenues from our licensing arrangements. To date, these collaborative arrangements have included out-licensing of and options to out-license in-licensed compounds to other parties. These arrangements may include non-refundable upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost reimbursement arrangements and royalty payments. Our revenue related to its out-licensing collaborative agreements consists of product revenue, upfront license fees, royalty revenue and research and development services revenue from its collaboration agreements.

Current wording

Prior to our commercialization of IBTROZI, substantially all of our revenue was generated from payments under prior collaboration agreements, and milestones, royalties and other revenue from our licensing arrangements. To date, these collaborative arrangements have included out-licenses of and options to out-license in-licensed compounds to other parties. These arrangements may include non-refundable upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost reimbursement arrangements and royalty payments. Our revenue related to our out-licensing collaborative agreements consists of product revenue, upfront license fees, milestone payments, royalty revenue and research and development services revenue from its collaboration agreements.

Previous wording

Results of Operations for The Three and Nine Months Ended September 30, 2025 and 2024

Current wording

Results of Operations for The Three Months Ended March 31, 2026 and 2025

Previous wording

The following table summarizes total revenue recognized for the three and nine months ended September 30, 2025 and 2024 (in thousands):

Current wording

The following table summarizes total revenue recognized for the three months ended March 31, 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 $7.7 million and $9.0 million for the three and nine months ended September 30, 2025, 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+ 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 $18.5 million for the three months ended March 31, 2026.

Previous wording

Research and development expenses increased by $11.0 million for the nine months ended September 30, 2025 compared to 2024. The increase was primarily due to a $10.1 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation primarily related to one-time charge for the vesting of performance-based awards upon receiving U.S. FDA approval of taletrectinib, a $2.5 million increase in third-party costs related to clinical trial expense for taletrectinib, and a $0.2 million increase in amortization of assembled workforce offset by $1.8 million decrease due to a shift of manufacturing activities toward commercial drug production.

Current wording

Research and development expenses increased by $10.4 million for the three months ended March 31, 2026 compared to 2025. The increase was primarily due to a $1.5 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation, and $8.9 million increase in third-party costs related to clinical trial expense.

Previous wording

Other income, net decreased by $9.2 million for the nine months ended September 30, 2025 compared to 2024 primarily related to a decrease in interest income from investments of $4.9 million primarily due to lower treasury yield, a $6.7 million increase in interest expense offset by a $0.1 million increase in the change in fair value of warrant liability, $2.1 million increase in other income due to government subsidy income and a $0.2 million decrease in investment advisory fees.

Current wording

Other income, net decreased by $4.3 million for the three months ended March 31, 2026 compared to 2025 primarily due to a $6.7 million increase in interest expense primarily related to the Financing Agreement, a $1.0 million decrease in other income related to government subsidy income, a $0.2 million decrease in interest income from investments primarily due to lower treasury yield offset by an increase of $3.6 million in change in fair value of warrant liability.

Previous wording

From inception through September 30, 2025, 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 September 30, 2025, we had $549.0 million in cash, cash equivalents and marketable securities and an accumulated deficit of $1,078.8 million.

Current wording

From inception through March 31, 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 March 31, 2026, we had $533.7 million in cash, cash equivalents and marketable securities and an accumulated deficit of $1,110.0 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

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 “RIF Agreement”) and a $100.0 million senior secured term loan with Sagard Holdings Manager LP (the “Loan

Previous wording

(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 was funded on June 25, 2025, following FDA’s approval of IBTROZI. The second tranche of $50 million of the term loan will be available at our option until June 30, 2026, because we have achieved first U.S. commercial sale of IBTROZI.

Current wording

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 will be available at our option until June 30, 2026.

Previous wording

Based upon our current operating plan, we believe that our existing cash, cash equivalents and marketable securities as of September 30, 2025, 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 March

Previous wording

We expect to incur substantial expenses in the foreseeable future for the development and commercialization of our product candidates and ongoing internal research and development programs. At this time, we cannot reasonably estimate the nature, timing or aggregate amount of costs for our development, commercialization, and internal research and development programs. However, in order to complete our current and future preclinical studies and clinical trials, and to complete the process of obtaining regulatory approval for our product candidates, as well as to commercialize our product candidates, we may require substantial additional funding in the future.

Current wording

We expect to incur substantial expenses in the foreseeable future for the development and commercialization of our product candidates and ongoing internal research and development programs. At this time, we cannot reasonably estimate the nature, timing or aggregate amount of costs for our development, commercialization, and internal research and development programs. However, in order to complete our current and future preclinical studies and clinical trials, and to complete the process of obtaining regulatory approval for our product candidates, as well as to commercialize our product candidates, we may require substantial additional funding in the future. We may consider additional funding through a combination of equity and debt financing, strategic alliances, and new collaborative arrangements.

Previous 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.

Current wording

In 2026, cash provided by operating activities of $5.1 million was attributable to a net income of $5.4 million, non-cash charges of $11.2 million offset by a net change of $11.5 million in our net operating assets and liabilities. The non-cash charges consisted primarily of stock-based compensation of $9.0 million, $5.1 million in non-cash interest expense related to the Financing Agreement, $0.5 million of depreciation and amortization, and $0.3 million of amortization of debt issuance costs offset by changes in fair value of warrant liability of $2.9 million, amortization of premium on marketable securities of $0.8 million, and $0.1 million of lease expense. The change in operating assets and liabilities was primarily due to a $12.3 million decrease in accrued expenses, $6.6 million increase in accounts receivable, $4.4 million increase in prepaid expenses and other current assets, $4.4 million increase in inventory, and $0.4 million decrease in contract liabilities offset by $13.0 million increase in accounts payable, and $3.8 million decrease in other non-current assets.

Previous wording

In 2024, cash used in operating activities of $84.1 million was attributable to a net loss of $518.5 million, a net change of $5.7 million in our net operating assets and liabilities offset by non-cash charges of $440.1 million. The change in operating assets and liabilities was primarily due to a $1.9 million decrease in contract liabilities, $7.3 million increase in prepaid expenses and other current assets, $0.5 million decrease in accrued expenses, $0.4 million increase in interest receivable on marketable securities and $0.1 million increase in accounts receivable offset by $4.4 million increase in accounts payable and $0.1 million decrease in other non-current assets. The non-cash charges consisted primarily of $425.1 million of acquired in-process research and development, stock-based compensation of $22.1 million, $0.4 million of depreciation and amortization and $0.2 million of net loss on disposal of property and equipment offset by amortization of premium on marketable securities of $7.4 million, changes in fair value of warrant liability of $0.2 million and $0.1 million of non cash lease expense.

Current wording

In 2025, cash used in operating activities of $42.6 million was attributable to a net loss of $53.2 million offset by a net change of $2.7 million in our net operating assets and liabilities and non-cash charges of $7.9 million. The change in operating assets and liabilities was primarily due to a $12.3 million decrease in accounts receivable, $4.2 million increase in accounts payable, and $0.1 million decrease in other non-current assets offset by $8.9 million decrease in accrued expenses, $2.3 million decrease in contract liabilities, $1.2 million increase in prepaid expenses and other current assets and $1.5 million increase in interest receivable on marketable securities. The non-cash charges consisted primarily of stock-based compensation of $7.9 million, changes in fair value of warrant liability of $0.8 million, $0.3 million of depreciation and amortization, $0.2 million of lease expense and $0.2 million of foreign currency transaction gain offset by amortization of premium on marketable securities of $1.5 million.

Previous 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.

Current wording

In 2025, cash provided by investing activities of $54.2 million was related to the $115.0 million of proceeds from the sale of marketable securities offset by purchase of marketable securities of $60.7 million and $0.1 million purchase of property and equipment.

Previous wording

In 2024, cash provided by financing activities of $1.2 million was related to the $3.6 million proceeds from exercise of options and $0.1 million of proceeds from issuance of Common Stock under the Employee Stock Purchase Plan and $7.0 million of proceeds from borrowings offset by $9.5 million of debt repayments.

Current wording

In 2026, cash provided by financing activities of $0.1 million was related to the $0.9 million proceeds from exercise of options offset by $0.8 million of debt repayments.

Previous wording

In 2025, cash provided by financing activities of $194.5 million was related to the $150.0 million proceeds from the RIF 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 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 revenue interest financing agreement.

Current wording

In 2025, cash provided by financing activities of $0.6 million was related to the $1.1 million proceeds from exercise of options offset by $0.5 million of debt repayments.

Previous wording

Our management’s discussion and analysis of financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. On an on-going basis, we evaluate our critical accounting policies and estimates. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable in the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions and conditions.

Current wording

Our management’s discussion and analysis of our financial condition and results of operations is based upon our consolidated financial statements. We prepare these financial statements in conformity with GAAP. As such, we are required to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the periods presented. We base our estimates on historical experience, available information and various other assumptions we believe to be reasonable under the circumstances. On an ongoing basis, we evaluate our estimates; however, actual results may differ from these estimates under different assumptions or conditions. There have been no material changes or developments in our evaluation of the accounting estimates and the underlying assumptions or methodologies that we believe to be Critical Accounting Policies and Estimates as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.