Nuvation Bio Inc.
For the period ended Jun 30, 2025. Filed Aug 7, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 7, 2025
NUVB$4.16-0.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-07.
0000950170-25-065712
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0000950170-25-104626
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 109 previous paragraphs and 110 current paragraphs.
66 unchanged; 24 reworded; 16 added; 16 removed; 3 previous and 4 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 (16)
Current report
In June 2025, taletrectinib (IBTROZI) was added as a Preferred Agent in the latest National Comprehensive Cancer Network Clinical Practice Guidelines ® ("NCCN Guidelines") in Oncology. Specifically, the NCCN Guidelines now include taletrectinib (IBTROZI) as a Preferred Agent for both first-line and subsequent therapy for ROS1+ NSCLC, including specific recommendations for those with brain metastases and resistance mutations.
Current report
Research and Development Expenses
Current report
Our revenues consist of product revenue, net and revenues related to our out-licensing collaborative and license agreements consists of upfront license fees, royalty revenue, products supply and research and development services revenue.
Current report
Product Revenue, Net
Current report
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 report
Collaboration and License Agreements Revenue
Current report
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 report
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 report
Research and Development Expenses
Current report
Research and development expenses decreased by $1.9 million for the three months ended June 30, 2025 compared to 2024. The decrease was due to a $4.3 million decrease in third-party costs as the prior period included costs for the preparation of a New Drug Application (NDA) for taletrectinib for submission to the U.S. FDA and a $1.8 million decrease due to a shift of manufacturing activities toward commercial drug production, offset by a $3.2 million increase in salaries and other benefits driven by the increase in headcount and $1.0 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.
Current report
On April 9, 2024, as a result of the acquisition of AnHeart, we recorded a $425.1 million charge representing an acquired in-process research and development asset with no alternative future use in acquired in-process research and development expenses.
Current report
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 report
Product revenue, net
Current report
The Company recognizes product revenue, net of variable consideration related to certain allowances and accruals, when the customer takes control of the product, which is typically upon delivery to the customer. Product revenue is recorded at the net sales price, or transaction price. The Company records product revenue reserves, which are classified as a reduction in product revenues, to account for the components of variable consideration. Variable consideration includes the following components: chargebacks, government rebates, commercial payer rebates, trade discounts and allowances, product returns, and co-payment assistance. Calculating certain of these items involves estimates and judgments based on sales or invoice data, contractual terms, historical utilization rates, new information regarding changes in applicable regulations and guidelines that would impact the amount of the actual rebates, our expectations regarding future utilization rates and channel inventory data. We review the adequacy of our provisions for sales deductions on a quarterly basis. Amounts accrued for sales deductions are adjusted when trends or significant events indicate that adjustment is appropriate and to reflect actual experience. The most significant items deducted from gross product sales where we exercise judgment are rebates, sales returns and chargebacks.
Current report
Interest-bearing loans and borrowings
Current report
The Company will indicate that the carrying amount of the liability for sale of future royalties is based on management's estimate of the future royalties to be paid over the life of the arrangement using an imputed rate of interest. The liability is amortized using the effective interest rate method, resulting in recognition of non-cash interest expense over the estimated term of the agreement. If there are changes to the estimate, we recognize the impact to the liability’s amortization schedule and the related non-cash interest expense prospectively. Such costs are recognized under Interest expense in the Consolidated Statements of Operations and Comprehensive Loss and under Accrued expenses on the Consolidated Balance Sheets.
Removed paragraphs (16)
Previous report
In March 2025, we entered into a commercial supply agreement with Asymchem Laboratories (Tianjin) Co., Ltd. for the supply of taletrectinib drug substance, and a commercial supply agreement with Asymchem Life Science (Tianjin) Co., Ltd. for the supply of taletrectinib drug product.
Previous report
Our revenue related to its out-licensing collaborative agreements consist of product revenue, upfront license fees, royalty revenue and research and development services revenue from its collaboration agreements.
Previous report
There was no revenue for the three months ended March 31, 2024 since the acquisition of AnHeart completed in the second quarter of 2024.
Previous report
Warrant Liability
Previous report
We account for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the company’s own ordinary shares, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
Previous report
For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded as a liability at their fair value on the date of issuance and each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. The fair value of Consideration, Public, and Forward Purchase Warrants was determined using the closing price of the publicly traded warrants on the NYSE market. The fair value of the Private Placement Warrants was estimated using a Black-Scholes option pricing model (see Note 3).
Previous report
Stock-Based Compensation Expense
Previous report
We estimate the fair value of our stock-based awards to employees and non-employees that are based on a service condition only using the Black-Scholes option-pricing model, which is impacted by our Common Stock price as well as other variables including, but not limited to, expected term that options will remain outstanding, expected Common Stock price volatility over the term of the option awards, risk-free interest rates and expected dividends.
Previous report
We determine the fair value of stock-based awards that are based on both a service condition and achievement of the first to occur of a market or performance condition using a Monte Carlo simulation.
Previous report
The fair value of a stock-based award is recognized over the period during which a recipient is required to provide services in exchange for the award, known as the requisite service period (usually the vesting period) on a straight-line basis. Stock-based compensation expense is recognized based on the fair value determined on the date of grant and is reduced for forfeitures as they occur.
Previous report
Estimating the fair value of stock-based awards as of the grant date using valuation models, such as the Black-Scholes option pricing model, is affected by assumptions regarding a number of variables. Changes in the assumptions can materially affect the fair value and ultimately how much stock-based compensation expense is recognized. These inputs are subjective and generally require significant analysis and judgment to develop.
Previous report
Expected Term—We have opted to use the “simplified method” for estimating the expected term of options whose vesting is based on service condition only, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option (generally 10 years).
Previous report
Expected Volatility—Due to our limited operating history and a lack of company specific historical and implied volatility data, we have based our estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded.
Previous report
Risk-Free Interest Rate—The risk-free rate assumption is based on the U.S. Treasury instruments with maturities similar to the expected term of our stock options at the time of the grant.
Previous report
Expected Dividend—We have not issued any dividends in our history and do not expect to issue dividends over the life of the options and therefore have estimated the dividend yield to be zero.
Previous report
We will continue to use judgment in evaluating the expected volatility, and interest rates utilized for our stock-based compensation expense calculations on a prospective basis.
Reworded paragraphs (24)
Previous wording
We are a global oncology company focused on tackling some of the toughest challenges in cancer treatment by 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 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.
Previous wording
Our most advanced product candidate, taletrectinib, is an oral, potent, central nervous system-active, selective, next-generation c-ros oncogene 1 (“ROS1”) inhibitor specifically designed for the treatment of patients with ROS1-positive (“ROS1+”) non-small cell lung cancer ("NSCLC"). Taletrectinib is being 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. Taletrectinib has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (“FDA”) for the treatment of patients with ROS1+ NSCLC and other NSCLC indications, and 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. Based on pooled results of the TRUST-I and TRUST-II studies, we submitted a New Drug Application (“NDA”) for taletrectinib to the U.S. FDA in October 2024 for the treatment of patients with advanced ROS1+ NSCLC (line agnostic, full approval). On December 22, 2024, the FDA accepted the NDA for Priority Review and assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of June 23, 2025. In China, taletrectinib has been approved 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”). 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 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”).
Previous wording
In addition to taletrectinib, our clinical-stage pipeline includes differentiated, novel oncology product candidates that have been generated from our proprietary drug discovery and development programs or acquired through business development activities:
Current wording
Our clinical-stage pipeline includes differentiated, novel oncology product candidates that have been generated from our proprietary drug discovery and development programs or acquired through business development activities:
Previous wording
Safusidenib is a novel, oral, potent, brain penetrant, targeted inhibitor of mutant isocitrate dehydrogenase 1 ("mIDH1"). Safusidenib is being evaluated in a Phase 2 study in patients with diffuse IDH1-mutant glioma. We expect to provide an update on the pivotal study design for the safusidenib program in the second half of 2025.
Current wording
Safusidenib is a novel, oral, potent, brain penetrant, targeted inhibitor of mutant isocitrate dehydrogenase 1 ("mIDH1"). We recently published an updated trial design of the randomized phase 2 study of safusidenib in diffuse IDH1-mutant glioma, which will now evaluate maintenance treatment with safusidenib against placebo in high grade IDH1-mutant glioma. Discussion with the FDA regarding registration-enabling trials of safusidenib are ongoing and we plan to provide additional updates in the second half of 2025.
Previous wording
In March 2025, we announced that we secured up to $250.0 million in non-dilutive financing from Sagard Healthcare Partners. We will receive $150.0 million in royalty interest financing and $50.0 million in debt upon U.S. FDA approval of taletrectinib by September 30, 2025, with access to an additional $50.0 million in debt at the Company’s option after first commercial sale of taletrectinib.
Current wording
In June 2025, under our non-dilutive financing agreements with Sagard Healthcare Partners, we received $150.0 million in royalty interest financing and $50.0 million in debt and have access to an additional $50.0 million in debt at the Company’s option until June 2026.
Previous wording
We have incurred net losses in each year since inception. As of March 31, 2025, we had an accumulated deficit of $964.0 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 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:
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 synthetic royalty financing and a $100.0 million senior secured term loan. The $150 million from the synthetic royalty financing and the first $50.0 million tranche of the term loan will be funded conditioned upon FDA’s approval of taletrectinib on or prior to September 30, 2025. The transaction will support the U.S. launch of taletrectinib and general corporate purposes.
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 synthetic royalty financing and a $100.0 million senior secured term loan. The $150 million from the synthetic royalty financing and the first $50.0 million tranche of the term loan was funded on June 25, 2025 upon FDA’s approval of IBTROZI. The transaction will support the U.S. launch of IBTROZI and general corporate purposes.
Previous wording
We enter into collaborative arrangements for the research and development, and commercialization of drug products and drug candidates. 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 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.
Previous wording
Results of Operations for The Three Months Ended March 31, 2025 and 2024
Current wording
Results of Operations for The Three and Six Months Ended June 30, 2025 and 2024
Previous wording
The following table summarizes total revenue recognized for the three months ended March 31, 2025:
Current wording
The following table summarizes total revenue recognized for the three and six months ended June 30, 2025 and 2024 (in thousands):
Previous wording
Research and development expenses increased by $11.8 million for the three months ended March 31, 2025 compared to 2024. The increase was primarily due to a $6.2 million increase in personnel-related costs driven by the acquisition of AnHeart as well as stock-based compensation and other benefits and $0.2 million increase in amortization of assembled workforce and $5.4 million increase in third-party costs related to clinical trial expense for taletrectinib.
Current 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.
Previous wording
Selling, general and administrative expenses increased by $28.0 million for the three months ended March 31, 2025, compared to 2024. The increase was due to a $10.7 million increase in personnel-related costs as a result of the acquisition of AnHeart, $12.2 million increase in sales and marketing expenses, $1.4 million increase in professional fees, $0.5 million increase in occupancy expenses, $1.1 million increase in legal fees, $0.2 million increase in foreign currency impact and $2.0 million increase in other expenses as a result of the integration of AnHeart offset by $0.1 million decrease in taxes.
Current 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.
Previous wording
Other income (expense), net increased by $0.4 million for the three months ended March 31, 2025 compared to 2024 primarily related to a $1.5 million increase in other income due to government subsidy income, a $0.7 million increase in the change in fair value of warrant liability, a $0.1 million decrease in investment advisory fees offset by decrease in interest income from investments of $1.8 million primarily due to lower treasury yield and a $0.1 million increase in interest expense.
Current 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.
Previous wording
From inception through March 31, 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 March 31, 2025, we had $461.7 million in cash, cash equivalents and marketable securities and an accumulated deficit of $964.0 million.
Current 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.
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 will be funded conditioned upon FDA’s approval of taletrectinib on or prior to September 30, 2025. The second tranche of $50 million of the term loan will be available at our option until June 30, 2026, as long as we have achieved first U.S. commercial sale of taletrectinib.
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 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
Under the RIF Agreement, in exchange for the Investment Amount, we have agreed to make tiered royalty payments to Sagard on U.S. net sales of taletrectinib 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 will 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 taletrectinib 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 taletrectinib and general corporate purposes.
Current wording
Under the RIF Agreement, in exchange for the Investment Amount, we have 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 will 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.
Previous wording
We expect to incur substantial expenses in the foreseeable future for the development and potential 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, potential 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 build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, if approved, 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.
Previous wording
In 2024, cash used in operating activities of $15.7 million was attributable to a net loss of $14.8 million, a net change of $4.6 million in our net operating assets and liabilities offset by non-cash charges of $3.7 million. The change in operating assets and liabilities was primarily due to a $5.3 million increase in prepaid expenses and other current assets, $0.6 million increase in interest receivable on marketable securities, $0.5 million increase in other non-current assets offset by $1.5 increase in accrued expenses and $0.3 million increase in accounts payable. The non-cash charges consisted primarily of stock-based compensation of $5.0 million and changes in fair value of warrant liability of $1.5 million offset by amortization of premium on marketable securities of $2.8 million.
Current 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.
Previous 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.
Current 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.
Previous 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.
Current 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.
Previous wording
In 2024, cash provided by investing activities of $7.5 million was related to the purchase of marketable securities of $128.5 million offset by $136.0 million of proceeds from the sale of marketable securities.
Current 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.
Previous wording
In 2024, cash provided by financing activities of $21 thousand was related to the proceeds from exercise of options.
Current 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.
Previous 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.
Current 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.
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 months ended March 31, 2025, the Company has recognized $0.2 million 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 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.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
Acquired In-process Research and Development Expenses
Current report — wording carried from elsewhere
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.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
In January 2025, China’s NMPA approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not been previously treated with ROS1 TKIs.
Previous report — wording carried elsewhere
In March 2025, our commercialization partner in Japan, Nippon Kayaku Co., Ltd., completed submission of a MAA for taletrectinib for advanced ROS1+ NSCLC to Japan’s PMDA.
Previous report — wording carried elsewhere
We expense all research and development costs in the periods in which they are incurred. Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks and estimates of services performed using information and data provided to us by our vendors and third-party service providers. Nonrefundable advance payments for goods or services to be received in future periods for use in research and development activities are deferred and capitalized. The capitalized amounts are then expensed as the related goods are delivered and as services are performed. We expense in-process research and development projects acquired as part of asset acquisitions that have no alternative future use.