NUVB 10-K & 10-Q changes, risk factors and insider trading

Risks Related to Commercialization of IBTROZI

Our near-term prospects are significantly dependent on the commercialization of IBTROZI. If we are unable to successfully commercialize IBTROZI, our ability to generate meaningful revenue or achieve profitability will be materially and adversely affected.

In June 2025, we received FDA approval to commercialize IBTROZI in the U.S. for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC, and we initiated a commercial launch of IBTROZI in the U.S. in that indication. IBTROZI is our only product approved for marketing by the FDA, and our ability to generate revenue from product sales and achieve profitability is mostly dependent on our ability to successfully commercialize IBTROZI in the U.S. We may not be able to successfully commercialize IBTROZI for a number of reasons, including:

we may not be able to establish or demonstrate in the medical community the safety and efficacy of IBTROZI and its potential advantages over existing treatments;

physicians may be reluctant to prescribe IBTROZI until longer-term efficacy and safety data exists;

the length of time that patients who are prescribed IBTROZI remain on treatment may be shorter than we anticipate;

our limited historical experience in marketing, selling and distributing IBTROZI;

our ability to access or reach prescribers;

the reimbursement and coverage policies of government and private payors such as Medicare, Medicaid, insurance companies, health maintenance organizations and other plan administrators;

our ability to influence testing and appropriate patient identification processes within accounts, especially in the community setting where testing and patient identification rates are lower than in the academic setting;

the relative price of IBTROZI as compared to alternative treatment options;

the relatively low incidence and prevalence of patients in IBTROZI’s approved indication, including the reliability of our market and sales estimates;

future competitive or other market factors that may adversely affect the commercial potential of IBTROZI;

we may not be able to obtain and maintain regulatory approvals for taletrectinib in any other jurisdictions or for any other indications;

changed or increased regulatory restrictions;

changes to the label for IBTROZI that could restrict how we market and sell IBTROZI, including adverse events observed in ongoing and future studies of taletrectinib such as TRUST-I and TRUST-II;

the capabilities of third-party manufacturers may adversely affect the success of our commercialization of IBTROZI; and we may not be able to maintain adequate commercial supplies of IBTROZI to meet demand.

Moreover, successful commercialization of IBTROZI may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all. If we are unable to successfully commercialize IBTROZI, our ability to generate meaningful revenue from product sales and achieve profitability will be materially and adversely affected, which in turn would severely and adversely affect our financial results, business and business prospects.

We have limited experience as a commercial company and our sales, marketing, and distribution of IBTROZI may be unsuccessful or less successful than anticipated.

As a company, we have limited experience in selling and marketing or commercializing an approved drug product in the U.S., and no such experience outside of the U.S. The success of our U.S. commercialization efforts is subject to, among other things, managing our internal sales, marketing, and distribution capabilities and our ability to navigate the significant expenses and risks involved with the management of such capabilities. For example, our commercial launch of IBTROZI in the U.S. may not continue as planned or anticipated, which may require us to, among others, adjust or amend our commercialization plan and incur significant expenses. If we are unsuccessful in accomplishing our objectives or if our commercialization efforts do not continue as planned, we may not be able to successfully commercialize IBTROZI, we may require significant additional capital and financial resources, we may not become profitable, and we may not be able to compete against more established companies in our industry, any of which would severely and adversely affect our financial results, business and business prospects.

Given our limited experience in marketing and selling IBTROZI in the U.S., our initial estimate of the size of the required sales force may be materially more or less than the size of the sales force actually required to effectively commercialize IBTROZI. As such, we may be required to hire substantially more sales representatives and medical support liaisons to adequately support the commercialization of IBTROZI, or we may incur excess costs as a result of hiring more sales representatives and medical support liaisons than necessary.

If the market opportunities for IBTROZI are smaller than we believe, our revenue may be adversely affected, and our business may suffer.

We are commercializing IBTROZI in advanced ROS1+ NSCLC, and the addressable patient population in advanced ROS1+ NSCLC is based on our estimates. These estimates, which have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations and market research, may prove to be incorrect. Further, new information from us or others may change the estimated incidence or prevalence of patients with advanced ROS1+ NSCLC. We may be unable to successfully identify patients and achieve a significant market share in IBTROZI’s approved indication.

Our market opportunity may also be limited by the pricing, reimbursement and access we are able to achieve for IBTROZI, the quality and expiration of our intellectual property rights and regulatory exclusivity, duration of IBTROZI treatment in advanced ROS1+ NSCLC and future competitor treatments that enter the market. If any of our estimates prove to be inaccurate, the market opportunities for IBTROZI that we or any potential future collaborative partners develop could be significantly diminished, which would have a material adverse impact on our business and business prospects, and would adversely affect our ability to achieve profitability.

IBTROZI may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

If IBTROZI does not achieve an adequate level of acceptance, we may not generate significant product revenues and we may never become profitable. For example, current approved immunotherapies, and other cancer treatments like chemotherapy and radiation therapy, are well established in the medical community, and doctors may continue to rely on these therapies. The degree of market acceptance of IBTROZI will depend on a number of factors, including:

the ability of IBTROZI to treat advanced ROS1+ NSCLC, as compared with other available drugs, treatments or therapies;

the label and promotional claims allowed by the FDA for IBTROZI and any limitations or warnings about the prevalence or severity of any side effects;

the effectiveness of sales, marketing and distribution support for IBTROZI;

the ability of the third-party distributors and specialty pharmacies we contract with to process prescriptions and dispense IBTROZI and the processes required to place orders with such distributors and specialty pharmacies;

the pricing and cost effectiveness of IBTROZI, both in absolute terms and relative to alternative treatments;

the extent to which IBTROZI is approved for inclusion on formularies in hospitals and managed care organizations;

our ability to obtain sufficient third-party coverage and adequate reimbursement; and the willingness of patients to pay out-of-pocket in the absence of coverage by third-party payors, including governmental authorities.

The successful commercialization of IBTROZI and our product candidates will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels and pricing policies. Failure to obtain or maintain adequate coverage and reimbursement for IBTROZI or our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.

The availability and adequacy of coverage and reimbursement by governmental healthcare programs such as Medicare and Medicaid in the U.S., comparable foreign healthcare programs, private health insurers and other third-party payors are essential for most patients to be able to afford products such as IBTROZI. Our ability to achieve acceptable levels of coverage and reimbursement for products by governmental authorities, private health insurers and other organizations will have an effect on our ability to successfully commercialize IBTROZI and our product candidates, if approved, and, if desired, attract collaboration partners to invest in the development of our product candidates. Coverage under certain government programs, such as Medicare, Medicaid, the 340B drug pricing program and TRICARE, or comparable foreign healthcare programs, may not be available for IBTROZI and certain of our product candidates, if approved. Assuming we obtain coverage for a given product by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. We cannot be sure that coverage and reimbursement in the U.S., European Union Member States, China or elsewhere will be available for any product that we may develop, and any reimbursement that may become available may be decreased or eliminated in the future.

Taletrectinib is also approved in China for the treatment of advanced ROS1+ NSCLC and sold under the brand name DOVBLREON. In China, the Ministry of Human Resources and Social Security of China or provincial or local human resources and social security authorities, together with other government authorities, review the inclusion or removal of drugs from China’s National Drug Catalog for Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance, or the National Reimbursement Drug List (“NRDL”), or provincial or local medical insurance catalogues for the National Medical Insurance Program regularly, and the tier under which a drug will be classified, both of which affect the amounts reimbursable to program participants for their purchases of those drugs. There can be no assurance that taletrectinib or any of our product candidates, if approved, will be included in the NRDL. Products included in the NRDL have been typically generic and essential drugs. Innovative drugs similar to taletrectinib have historically been more limited on their inclusion in the NRDL due to the affordability of the government’s Basic Medical Insurance, although this has been changing in recent years. Obtaining and maintaining reimbursement status is time-consuming and costly. No uniform policy for coverage and reimbursement for products exists among third-party payors in the U.S. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Furthermore, rules and regulations regarding reimbursement change frequently, in some cases at short notice, and we believe that changes in these rules and regulations are likely.

Moreover, increasing efforts by governmental and third-party payors in the U.S. and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidates. For example, HHS imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis. In addition, HHS has been empowered to negotiate the price of certain single-source drugs that have been on the market for at least 7 years covered under Medicare as part of the Medicare Drug Price Negotiation Program. Each year up to 20 products will be selected by HHS for the Medicare Drug Price Negotiation Program. Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis. If coverage and adequate reimbursement are not available, or are available only to limited levels, we may not be able to successfully commercialize IBTROZI and our product candidates that we develop, which could have an adverse effect on our operating results and our overall financial condition.

We expect to experience pricing pressures in connection with the sale of any of our product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations, and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. The continuing efforts of the government, insurance companies, managed care organizations and other payors of health care services to contain or reduce costs of health care may adversely affect:

our ability to generate revenues and achieve or maintain profitability; and the amount of taxes that we are required to pay.

We rely on a select network of third-party distributors, specialty pharmacies and other vendors to distribute IBTROZI in the U.S., and any failure by such distributors, specialty pharmacies and vendors could adversely affect our revenues, financial condition, or results of operations.

We rely on a select network of third-party distributors, specialty pharmacies and other vendors to distribute IBTROZI in the U.S., and the financial failure of any of these parties could adversely affect our revenues, financial condition or results of operations. We rely on such distributors and specialty pharmacies to effectively distribute IBTROZI in a timely manner, provide certain patient support services, manage prescription intake, collect accurate patient and inventory data and collect payments from payors. While we have entered into agreements with each of these parties, they may not perform as agreed, our strategic priorities may change or they may terminate their agreements with us. Further, an inability by our distributors or specialty pharmacies to meet our patients’ needs may lead to reputational harm or patient loss. In the event that such network fails to properly meet our or our patients’ needs, we may need to partner with other distributors, specialty pharmacies or vendors to replace or supplement our current network and there is no guarantee that we will be able to do so on commercially reasonable terms or at all.

If competitors develop products, product candidates or technologies that are superior to or more cost-effective than IBTROZI, it would significantly impact the development and commercial viability of IBTROZI, which would severely and adversely affect our financial results, business and business prospects, and the future of IBTROZI, and might cause us to cease operations.

The pharmaceutical and biotechnology industries are characterized by intense and dynamic competition with rapidly advancing technologies and a strong emphasis on proprietary products. IBTROZI competes with other products and therapies that currently exist, are being developed or will in the future be developed, some of which we may not currently be aware of.

Competitors may develop more commercially desirable or affordable products than IBTROZI. Competitors have developed, or are in the process of developing, technologies that are, or in the future may be, competitive to IBTROZI. Some of these products may have an entirely different approach or means of accomplishing therapeutic effects similar or superior to those that may be demonstrated by IBTROZI. Competitors may develop products that are safer, more effective, or less costly than IBTROZI, or more convenient to administer to patients and, therefore, present a serious competitive threat to IBTROZI. In addition, competitors may price their products below what we may determine to be an acceptable price for IBTROZI, may receive better third-party payor coverage and/or reimbursement, or may be more cost-effective than IBTROZI. Such competitive products or activities by competitors may render IBTROZI obsolete, which may cause us to cease any further development or future commercialization of IBTROZI, which would severely and adversely affect our financial results, business and business prospects, and the future of IBTROZI.

If we are unable to maintain our agreements with third parties to sell and market taletrectinib in jurisdictions outside of the U.S. or our partnered territories, we will be unable to successfully commercialize taletrectinib if and when it is approved in such jurisdictions.

We have out-licensed commercial rights to taletrectinib to Innovent in mainland China, Hong Kong, Macau and Taiwan; to NK in Japan; and to Eisai in Europe and other territories. In the future, we may choose to build a focused sales and marketing infrastructure to sell, or participate in sales activities with our collaborators for, taletrectinib in territories outside of the U.S. and territories subject to existing partnerships, or for our other product candidates if and when they are approved.

There are risks involved with both establishing our own sales and marketing capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force is expensive and time-consuming and could delay any product launch. If the commercial launch of a product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

the lack of complementary products offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and unforeseen costs and expenses associated with creating an independent sales and marketing organization.

Failure by us to maintain a manufacturing supply chain to appropriately and adequately supply IBTROZI for commercial and future clinical uses would adversely affect our ability to commercialize IBTROZI and/or result in a further delay in or cessation of clinical trials, and our business and business prospects could be severely harmed.

The manufacture of IBTROZI must comply with applicable regulatory standards for commercial uses and current and potential future clinical trials. The process of manufacturing IBTROZI is complex and subject to several risks, including:

the ability to consistently manufacture sufficient yields with acceptable quality control and quality assurance to meet market demand for our commercialization of IBTROZI, as well as the needs for continuing clinical trials;

our ability to maintain existing commercial supply agreements and to establish additional or alternative supply agreements if necessary, including our ability to successfully transfer manufacturing technology and attain regulatory approval at any such additional or alternative suppliers;

reliance on third-party manufacturers and suppliers, whose efforts we do not control;

supply chain issues, including the timely availability of product raw materials, drug substance, and drug product and other supplies, any of which may be impacted by a number of factors, including the effects of macroeconomic or other global conditions;

shortage of qualified personnel at any of our third-party suppliers; and regulatory acceptance and continued compliance with regulatory requirements, which vary in each country.

As a result of these and other risks, we may be unable to maintain a manufacturing infrastructure and supply chain capable of providing IBTROZI for clinical and commercial use, which would delay or adversely affect our IBTROZI commercialization efforts; result in lost sales; delay or result in a cessation of our current or potential future clinical trials; delay or preclude potential future regulatory approvals of IBTROZI in other jurisdictions or indications; and could cause financial and reputational harm.

Risks Related to the Regulatory Approval of IBTROZI

We may be unable to maintain regulatory approval for IBTROZI in the U.S. or other jurisdictions, which would severely and adversely affect our business and business prospects.

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+ 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.

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.

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 in the SIGMA study, which is currently a randomized registration-enabling phase 3 study evaluating the efficacy and safety of safusidenib versus placebo for the maintenance treatment of patients with high-risk or high-grade IDH1-mutant astrocytoma following standard-of-care.

On November 8, 2025, positive results from a Phase 2 study of safusidenib in Japanese patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant gliomas were published in the online journal of Neuro-Oncology.

In January 2026, we announced entry into an exclusive license agreement for taletrectinib in Europe and additional countries with Eisai.

On February 10, 2026, the outstanding warrants to purchase Class A Common stock expired and were delisted pursuant to a Form 25 filed by The New York Stock Exchange.

Cost of Sales

Cost of sales includes primarily of all product related costs, third-party manufacturing, distribution, employee personnel costs and amortization of our licensed market approval for IBTROZI.

Cost of Collaboration and License Agreements Revenue

Cost of collaboration and license agreements revenue includes royalties on net sales of IBTROZI owed to our licensing partner and the proportion of expense recognized under the terms of our collaboration agreements.

Product Revenue, Net

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 $24.7 million for the year ended December 31, 2025.

Collaboration and License Agreements Revenue

Collaboration and license agreements revenue increased by $30.3 million for the year ended December 31, 2025 compared to 2024. The increase is primarily due to a $19.1 million increase in license revenue and a $6.3 million increase in research and development service revenue as a result of the milestone payment from Nippon Kayaku for the establishment of the reimbursement price in Japan in December 2025, a $1.3 million increase in royalty revenue, and a $3.6 million increase in product supply.

Cost of Sales

Cost of sales increased by $0.9 million for the year ended December 31, 2025 was primarily due to amortization of our licensed market approval. During the year ended December 31, 2024, there were no cost of sales recognized.

Cost of Collaboration and License Agreements Revenue

Cost of collaboration and license agreements revenue increased by $1.4 million for the year ended December 31, 2025 compared to 2024. The increase was primarily due to a $2.7 million increase in royalty payment for Daiichi Sankyo offset by $1.3 million decrease in research and development service costs under the term of our collaboration agreement with Innovent.

In 2025, cash used in operating activities of $173.4 million was attributable to a net loss of $204.6 million, net change of $12.0 million in our net operating assets and liabilities offset by non-cash charges of $43.2 million. The change in operating assets and liabilities was primarily due to a $3.4 million increase in accounts receivable, $11.4 million increase in inventory, $7.9 million decrease in contract liabilities, $4.3 million increase in prepaid expenses and other current assets, $0.8 million increase in other non-current assets offset by $3.1 million increase in accounts payable, $12.4 million increase in accrued expenses, and $0.3 million decrease in interest receivable on marketable securities. The non-cash charges consisted primarily of stock-based compensation of $35.9 million, $1.8 million of depreciation and amortization, $0.3 million of lease expense, $10.1 million in interest expense, $0.7 million of amortization of debt issuance costs, changes in fair value of warrant liability of $0.8 million offset by amortization of premium on marketable securities of $5.3 million, and $1.1 million of foreign currency transaction loss.

In 2025, cash provided by investing activities of $99.5 million was related to the $462.3 million of proceeds from the sale of marketable securities offset by purchase of marketable securities of $354.4 million, $8.0 million payment for capitalized market approval intangibles and $0.4 million purchase of property and equipment.

In 2025, cash provided by financing activities of $202.5 million was related to the $150.0 million proceeds from the RIF Agreement, $60.1 million proceeds from borrowings, $10.1 million proceeds from exercise of options and $1.3 million of proceeds from issuance of Common Stock under the Employee Stock Purchase Plan offset by $6.6 million payment of debt issuance costs, $11.9 million of debt repayments, and $0.5 million payment for revenue interest financing agreement.

We recognize 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. We record 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 payor 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.

We may not have the ability to raise the funds necessary to settle conversions of the Notes in cash, to repay the Notes at maturity or to repurchase the Notes upon a fundamental change, and our future debt may contain limitations on our ability to pay cash upon conversion or repurchase of the Notes.

In March 2025, we entered into a $150.0 million (the “Investment Amount”) synthetic royalty financing under the RIF Agreement and, in July 2026, we completed our registered underwritten public offering of $287.5 million aggregate principal amount of 0.75% Convertible Senior Notes due 2032 (the “Notes”). This level of debt could, among other things:

increase our vulnerability to adverse general economic and industry conditions, including interest rate fluctuations, because a portion of our borrowings bear, and will continue to bear, interest at floating rates;

under the RIF Agreement, upon occurrence of certain events, require us 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;

upon an event of default, which may allow lenders to accelerate amounts due or exercise certain remedies against us, including certain rights to take possession and dispose certain assets that are collateral;

limit our flexibility in planning for, or reacting to, changes in our business and industry;

restrict our ability to introduce new products or technologies or exploit business opportunities;

place us at a disadvantage compared with competitors that have proportionately less debt;

limit our ability to borrow additional funds in the future, if we need them, due to financial and restrictive covenants in our debt agreements;

limit our operating and financial flexibility due to financial and restrictive covenants in our debt agreements; and have a material adverse effect on us if we fail to comply with the financial and restrictive covenants in our debt agreements.

In addition, we may borrow additional capital in the future to fund clinical development and our future growth, including potentially pursuant to new arrangements with different lenders. To the extent additional debt is added to our current debt levels, the risks described above could increase.

In addition, our ability to make scheduled payments on or to refinance our debt obligations depends on our financial condition and operating performance, which is subject to prevailing economic and competitive conditions and to financial, business, legislative, regulatory and other factors, some of which are beyond our control. Any failure to make scheduled payments could adversely affect our business, financial condition and results of operations.

We may not have the ability to raise the funds necessary to settle conversions of the Notes in cash, to repay the Notes at maturity or to repurchase the Notes upon a fundamental change, and our future debt may contain limitations on our ability to pay cash upon conversion or repurchase of the Notes.

Holders of the Notes have the right, subject to certain conditions and limited exceptions, to require us to repurchase all or a portion of their Notes upon the occurrence of a fundamental change at a fundamental change repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest, if any. In addition, upon any conversion of the Notes, unless we elect to deliver solely shares of our Class A Common Stock to settle such conversion (other than paying cash in lieu of delivering any fractional share), we will be required to make cash payments in respect of the Notes being converted. We may not have enough available cash or be able to obtain financing at the time we are required to make repurchases of the Notes surrendered therefor or pay cash with respect to the Notes being converted or Notes being repaid at maturity. In addition, our ability to repurchase the Notes or to pay cash upon conversions or at maturity of the Notes may be limited by law, by regulatory authority, or by agreements governing our future indebtedness. Our failure to repurchase the Notes at a time when the repurchase is required by the indenture governing the Notes or to pay any cash payable on future conversions of the Notes or at maturity of the Notes, as required by the indenture, would constitute a default under the indenture. A default under the indenture or the fundamental change itself could also lead to a default under agreements governing our then-existing indebtedness. If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness and repurchase the Notes or make cash payments upon conversions of the Notes.

Conversion of the Notes may dilute the ownership interest of our stockholders or may otherwise depress the price of our Class A Common Stock.

The conversion of some or all of the Notes may dilute the ownership interests of our stockholders. Upon conversion of the Notes, we have the option to pay or deliver, as the case may be, cash, shares of our Class A Common Stock, or a combination of cash and shares of our Class A Common Stock. If we elect to settle our conversion obligation in shares of our Class A Common Stock or a combination of cash and shares of our Class A Common Stock with respect to conversions of the Notes, any sales in the public market of our Class A Common Stock issuable upon such conversion could adversely affect prevailing market prices of our Class A Common Stock. In addition, the existence of the Notes may encourage short selling by market participants because the conversion of the Notes could be used to satisfy short positions, or anticipated conversion of the Notes into shares of our Class A Common Stock could depress the price of our Class A Common Stock.

Certain provisions in the indenture governing the Notes may delay or prevent an otherwise beneficial takeover attempt of us.

Certain provisions in the indenture that governs the Notes may make it more difficult or expensive for a third party to acquire us. For example, the indenture that governs the Notes requires us, except as described in this prospectus supplement, to repurchase the Notes for cash upon the occurrence of a fundamental change and, in certain circumstances, to increase the conversion rate for a holder that converts its Notes in connection with a make-whole fundamental change. A takeover of us may trigger the requirement that we repurchase the Notes and/or increase the conversion rate, which could make it costlier for a potential acquirer to engage in such takeover. Such additional costs may have the effect of delaying or preventing a takeover of us that otherwise be beneficial to investors.

The capped call transactions may affect the market price of our Class A Common Stock.

In connection with the issuance of the Notes, we entered into capped call transactions with certain financial institutions (the “option counterparties”). The capped call transactions are expected generally to reduce the potential dilution to our Class A Common Stock upon any conversion of Notes and/or offset any cash payments we are required to make in excess of the principal amount of converted Notes, as the case may be, with such reduction and/or offset subject to a cap.

The option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to our Class A Common Stock and/or purchasing or selling our Class A Common Stock or other securities of ours in secondary market transactions prior to the maturity of the Notes. This activity could also cause or avoid an increase or a decrease in the market price of our Class A Common Stock or the Notes, which could affect the note holder’s ability to convert the Notes.

The potential effect, if any, of these transactions and activities on the market price of our Class A Common Stock or the Notes will depend in part on market conditions and cannot be ascertained at this time. Any of these activities could adversely affect the value of our Class A Common Stock.

We are subject to counterparty risk with respect to the capped call transactions, and the capped call transactions may not operate as planned.

The option counterparties are financial institutions, and we will be subject to the risk that any or all of them might default under the capped call transactions. If an option counterparty becomes subject to insolvency proceedings, we will become an unsecured creditor in those proceedings with a claim equal to our exposure at that time under the capped call transaction with such option counterparty. Our exposure will depend on many factors but, generally, an increase in our exposure will be correlated to an increase in the market price and in the volatility of our Class A Common Stock. In addition, upon a default by an option counterparty, we may suffer more dilution than we currently anticipate with respect to our Class A Common Stock.

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

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

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

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

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

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

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

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

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

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

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

The initial conversion rate for the Notes is 127.4941 shares of Class A Common Stock per $1,000 principal amount of Notes, which is equivalent to an initial conversion price of approximately $7.84 per share of Class A Common Stock. The conversion rate for the Notes is subject to customary adjustments for certain events as described in the indenture governing the Notes, but will not be adjusted for accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date or if we deliver a notice of redemption in respect of the Notes, we will, in certain circumstances, increase the conversion rate of the Notes for a holder who elects to convert its Notes in connection with such a corporate event or convert its Notes called (or deemed called) for redemption during the related redemption period, as the case may be.

We may not redeem the Notes prior to July 6, 2029. We have the option to redeem for cash all or any portion of the Notes (subject to certain limitations) on a redemption date on or after July 6, 2029 if the last reported sale price of the Class A Common Stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which we provide the related notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the Notes, which means that we are not required to redeem or retire the Notes periodically.

Holders may convert all or any portion of their Notes at their option at any time prior to the close of business on the business day immediately preceding before April 1, 2032 only upon satisfaction of one or more conditions. On or after April 1, 2032 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their Notes at their option at any time. Upon conversion, we will pay or deliver, as the case may be, cash, shares of Class A common stock, or a combination of cash and shares of Class A Common Stock, at our election, in the manner and subject to the terms and conditions provided in the indenture governing the notes.

In connection with the issuance of the Notes, we entered into capped call transactions in June 2026 and July 2026 with certain counterparties at a net cost of approximately $17.1 million. The capped call transactions are expected generally to reduce the potential dilution to the Class A Common Stock upon any conversion of the Notes and/or offset any cash payments we are required to make in excess of the principal amount of converted Notes, as the case may be, with such reduction and/or offset subject to a cap based on a cap price initially equal to $10.4580 per share, and is subject to certain adjustments under the terms of the capped call transactions.

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

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

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 $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.

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