Nuvation Bio Inc.

Previous wording

We are a global commercial-stage oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients’ lives. We were founded in 2018 by our chief executive officer, David Hung, M.D., who founded Medivation, Inc. and led its successful development of oncology drugs Xtandi® and talazoparib (now marketed as Talzenna®), leading to its $14.3 billion sale to Pfizer Inc. (“Pfizer”) in 2016. We leverage our team’s extensive expertise in medicinal chemistry, preclinical development, drug development, business development, manufacturing, and commercialization to pursue oncology targets validated by strong clinical or preclinical data and develop novel small molecules that improve the activity and overcome the liabilities of currently marketed drugs.

Current wording

We are a global oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients’ lives. We were founded in 2018 by our chief executive officer, David Hung, M.D., who founded Medivation, Inc. and led its successful development of oncology drugs Xtandi® and talazoparib (now marketed as Talzenna®), leading to its $14.3 billion sale to Pfizer Inc. (“Pfizer”) in 2016. We leverage our team’s extensive expertise in medicinal chemistry, preclinical development, drug development, business development, manufacturing, and commercialization to pursue oncology targets validated by strong clinical or preclinical data and develop novel small molecules that improve the activity and overcome the liabilities of currently marketed drugs.

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 in China for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs and is being commercialized 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. In March 2025, our commercialization partner in Japan, Nippon Kayaku Co., Ltd., completed submission of a Marketing Authorization Application (“MAA”) for taletrectinib for advanced ROS1+ NSCLC to Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”).

Current 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.

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.

Current 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.

Previous wording

In April 2025, pooled data from our pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib was published in the Journal of Clinical Oncology (Perol, et al., 2025).

Current wording

In September 2025, additional data from our pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib was presented at the 2025 World Conference on Lung Cancer.

Previous wording

In June 2025, the U.S. Food and Drug Administration has approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC.

Current wording

In September 2025, Japan’s MHLW approved IBTROZI for the treatment of adult patients with ROS1+ unresectable, advanced and/or recurrent NSCLC.

Previous wording

We have incurred net losses in each year since inception. As of June 30, 2025, we had an accumulated deficit of $1,023.0 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:

Current 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:

Previous wording

Results of Operations for The Three and Six Months Ended June 30, 2025 and 2024

Current wording

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

Previous wording

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

Current wording

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

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. Product revenue, net from U.S. sales of IBTROZI was approximately $1.2 million for the three months ended June 30, 2025.

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 $7.7 million and $9.0 million for the three and nine months ended September 30, 2025, respectively.

Previous wording

Collaboration and license agreement increased by $2.2 million for the three months ended June 30, 2025 compared to 2024. The increase was primarily due to a $0.9 million increase in products supply, $0.2 million increase in royalty revenue and a $1.1 million increase in research and development service revenue under the collaboration agreement with Innovent.

Current wording

Collaboration and license agreement increased by $4.7 million for the three months ended September 30, 2025 compared to 2024. The increase was due to a $3.8 million increase in research and development service revenue under the collaboration agreements with Nippon Kayaku and Innovent, a $0.6 million increase in products supply, and a $0.3 million increase in royalty revenue.

Previous wording

Collaboration and license agreement increased by $5.2 million for the six months ended June 30, 2025 compared to 2024. The increase was primarily due to a $1.7 million increase in products supply, $0.5 million increase in royalty revenue and a $3.0 million increase in research and development service revenue under the collaboration agreement with Innovent.

Current wording

Collaboration and license agreement increased by $9.9 million for the nine months ended September 30, 2025 compared to 2024. The increase was due to a $6.8 million increase in research and development service revenue under the collaboration agreements with Nippon Kayaku and Innovent, a $2.3 million increase in products supply, and a $0.8 million increase in royalty revenue.

Previous wording

Research and development expenses increased by $9.9 million for the six months ended June 30, 2025 compared to 2024. The increase was primarily due to a $10.0 million increase in salaries and other benefits driven by the increase in headcount and $2.1 million increase in stock compensation primarily related to one-time charge for the vesting of performance-based awards upon receiving U.S. FDA approval of taletrectinib, $0.1 million increase in amortization of assembled workforce, $1.1 million increase in third-party costs related to clinical trial expense for taletrectinib offset by $3.4 million decrease due to a shift of manufacturing activities toward commercial drug production.

Current 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.

Previous wording

Selling, general and administrative expenses increased by $50.4 million for the six months ended June 30, 2025, compared to 2024. The increase was due to a $19.3 million increase in personnel-related costs as a result of the increase in headcount, a $3.2 million increase in stock compensation primarily related to one-time charge for the vesting of performance-based awards upon receiving U.S. FDA approval of taletrectinib, $23.1 million increase in sales and marketing expenses, $2.8 million increase in other expenses as a result of systems built to prepare for the commercial launch of taletrectinib, $0.8 million increase in professional fees, a $0.9 million increase in occupancy expenses and a $0.6 million increase in legal fees offset by $0.3 million decrease in foreign currency impact.

Current wording

Selling, general and administrative expenses increased by $17.8 million for the three months ended September 30, 2025, compared to 2024. The increase was due to a $9.5 million increase in personnel-related costs as a result of the increase in headcount, a $6.4 million increase in sales and marketing expenses, a $2.2 million increase in other expenses as a result of systems built for the commercial launch of taletrectinib, and a $0.5 million increase in legal fees offset by a $0.3 million decrease in occupancy expenses, $0.3 million decrease in professional fees, and a $0.2 million decrease in foreign currency impact.

Previous wording

Selling, general and administrative expenses increased by $22.3 million for the three months ended June 30, 2025, compared to 2024. The increase was due to a $10.9 million increase in sales and marketing expenses, a $10.3 million increase in personnel-related costs as a result of the increase in headcount, a $1.5 million increase in stock compensation primarily related to one-time charge for the vesting of performance-based awards upon receiving U.S. FDA approval of taletrectinib, a $0.9 million increase in other expenses as a result of systems built to prepare for the commercial launch of taletrectinib, and a $0.4 million increase in occupancy expenses offset by $0.6 million decrease in professional fees, a $0.5 million decrease in legal fees and a $0.6 million decrease in foreign currency impact.

Current wording

Selling, general and administrative expenses increased by $68.1 million for the nine months ended September 30, 2025, compared to 2024. The increase was due to a $31.9 million increase in personnel-related costs as a result of 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, $29.3 million increase in sales and marketing expenses, $5.2 million increase in other expenses as a result of systems built to prepare for the commercial launch of taletrectinib, a $1.0 million increase in legal fees, a $0.5 million increase in professional fees, and a $0.4 million increase in occupancy expenses offset by $0.2 million decrease in foreign currency impact.

Previous wording

Other income (expense), net decreased by $3.3 million for the three months ended June 30, 2025 compared to 2024 primarily related to a decrease in interest income from investments of $2.4 million primarily due to lower treasury yield, a $0.7 million decrease in the change in fair value of warrant liability, a $0.3 million increase in interest expense offset by a $0.1 million decrease in investment advisory fees.

Current wording

Other income, net decreased by $6.2 million for the three months ended September 30, 2025 compared to 2024 primarily related to a decrease in interest income from investments of $0.7 million primarily due to lower treasury yield, a $6.4 million increase in interest expense, offset by a $0.1 million increase in the change in fair value of warrant liability, a $0.7 million increase in other income due to government subsidy income and a $0.1 million decrease in investment advisory fees.

Previous wording

Other income (expense), net decreased by $3.0 million for the six months ended June 30, 2025 compared to 2024 primarily related to a decrease in interest income from investments of $4.2 million primarily due to lower treasury yield and a $0.3 million increase in interest expense offset by a $1.5 million increase in other income due to government subsidy income and a $0.1 million decrease in investment advisory fees.

Current 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.

Previous wording

From inception through June 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 June 30, 2025, we had $607.7 million in cash, cash equivalents and marketable securities and an accumulated deficit of $1,023.0 million.

Current 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.

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 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

(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.

Previous wording

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 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 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 and $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 2024, cash used in operating activities of $53.0 million was attributable to a net loss of $477.3 million, a net change of $10.7 million in our net operating assets and liabilities offset by non-cash charges of $435.0 million. The change in operating assets and liabilities was primarily due to a $4.0 decrease in accrued expenses, $2.8 million decrease in accounts payable, $1.7 million increase in prepaid expenses and other current assets, $1.4 million decrease in contract liabilities, $0.2 million increase in interest receivable on marketable securities, $0.5 million increase in other non-current assets and $0.1 million increase in accounts receivable. The non-cash charges consisted primarily of $425.1 million of acquired in-process research and development, stock-based compensation of $14.6 million and changes in fair value of warrant liability of $0.3 million, $0.3 million of depreciation and amortization offset by amortization of premium on marketable securities of $5.2 million and $0.1 million of non cash lease expense.

Current 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.

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

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 2024, cash provided by investing activities of $41.8 million was related to the $251.3 million of proceeds from the sale of marketable securities, $19.8 cash acquired from the acquisition of AnHeart, offset by purchase of marketable securities of $221.9 million and $7.4 million of transaction costs related to the acquisition of AnHeart.

Current wording

In 2024, cash provided by investing activities of $70.9 million was related to the $366.2 million of proceeds from the sale of marketable securities, $19.9 cash acquired from the acquisition of AnHeart, offset by purchase of marketable securities of $307.6 million, $7.4 million of transaction costs related to the acquisition of AnHeart and purchase of property and equipment of $0.2 million.

Previous wording

In 2025, cash provided by financing activities of $194.0 million was related to the $150.0 million proceeds from the RIF Agreement, $48.9 million proceeds from the Loan Agreement, $1.9 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 $6.6 million payment of debt issuance costs and $0.7 million of debt repayments.

Current 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.

Previous wording

In 2024, cash provided by financing activities of $2.8 million was related to the $2.0 million proceeds from exercise of options and $0.1 million of proceeds from issuance of Common Stock under the Employee Stock Purchase Plan, $7.0 million of proceeds from borrowings offset by $6.3 million of debt repayments.

Current 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.

Previous wording

For sales-based royalties, including milestone payments based on the level of sales, we determine whether the sole or predominant item to which the royalties relate is a license. When the license is the sole or predominant item to which the sales-based royalty relates, we recognize revenue at the later of: (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). For the three and six months ended June 30, 2025, the Company has recognized $0.2 million and $0.5 million, respectively, sales-based royalty revenue resulting from the Company's collaboration agreements.

Current wording

For sales-based royalties, including milestone payments based on the level of sales, we determine whether the sole or predominant item to which the royalties relate is a license. When the license is the sole or predominant item to which the sales-based royalty relates, we recognize revenue at the later of: (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). For the three and nine months ended September 30, 2025, the Company has recognized $0.3 million and $0.8 million, respectively, sales-based royalty revenue resulting from the Company's collaboration agreements.