RIGEL PHARMACEUTICALS INC
For the period ended Jun 30, 2026. Filed Aug 4, 2026.
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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, 2026 · Filed Aug 4, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-05.
0001034842-26-000032
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-04.
0001034842-26-000052
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 184 previous paragraphs and 208 current paragraphs.
143 unchanged; 35 reworded; 30 added; 6 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 9 previous and 9 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 (30)
Current report
VEPPANU (vepdegestrant) is our fourth FDA-approved product which we expect to become commercially available in mid-August 2026. VEPPANU is an oral PROTAC approved by the FDA for the treatment of ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. We in-licensed VEPPANU pursuant to a license agreement entered in May 2026 with Arvinas and Pfizer.
Current report
Commercialized Products
Current report
GAVRETO net product sales for the six months ended June 30, 2026 were $20.3 million, a decrease of $0.5 million, or 2%, compared to $20.8 million for the same period in 2025. The decrease was primarily driven by lower volumes and higher revenue reserves, partially offset by higher price per bottle.
Current report
VEPPANU is our fourth FDA-approved product which we expect to become commercially available in mid-August 2026. We in-licensed VEPPANU pursuant to a license agreement entered in May 2026 with Arvinas and Pfizer (together, the Licensors), which agreement became effective on June 11, 2026 upon the early termination of the waiting period under the HSR Act. Pursuant to the license agreement, the Licensors granted us an exclusive, royalty-bearing license to develop, manufacture and commercialize VEPPANU (vepdegestrant) and vepdegestrant-containing products (the licensed products) worldwide. VEPPANU is approved in the US for the treatment of adults with ER+/HER2-negative,
Current report
ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
Current report
Under the license agreement, we agreed to pay the Licensors a license fee of up to $85.0 million, including $70.0 million upfront payment which we paid in June 2026, and up to an additional $15.0 million payable upon the successful completion of certain transition activities. In addition, the Licensors are eligible to receive up to $60.0 million in regulatory milestones upon achievement of specified regulatory approvals, and up to $260.0 million in commercial milestone payments upon achievement of specified net sales thresholds. We are also obligated to pay tiered royalties on annual net sales of licensed products ranging in percentages from the mid-teens to mid-twenties, subject to certain reductions and customary adjustments, and to share a portion of sublicense revenue with the Licensors at tiered rates that decrease based on the timing of execution of the applicable sublicense.
Current report
Under the license agreement, we will have the sole rights and will be primarily responsible for the development and commercialization of the licensed products worldwide, subject to certain transition activities to be performed by the Licensors. The license agreement includes customary diligence obligations for us to use commercially reasonable efforts to develop and commercialize the licensed products, including to seek regulatory approvals in specified major markets. The license agreement will remain in effect on a product-by-product and country-by-country basis until the expiration of the applicable royalty term for each licensed product in each country, after which the license becomes fully paid-up and perpetual. The license agreement may be terminated by either party under customary circumstances, including for material breach or certain insolvency events. In addition, the Licensors may terminate the license agreement if we cease all material development and commercialization activities for the licensed products for an extended period of time, subject to specified exceptions, or if we breach certain compliance-related obligations relating to anti-corruption and global trade controls. Upon termination of the license agreement prior to its expiration, the licenses granted to us will terminate and, at the Licensors’ request, the parties will negotiate in good faith an exclusive license from us to the Licensors under certain patent rights and know-how controlled by us covering the terminated licensed products. The license agreement contains customary provisions relating to, among other things, intellectual property, indemnification, confidentiality, and representations and warranties.
Current report
Pursuant to the license agreement, the Licensors will continue to be responsible for specified ongoing development, regulatory, manufacturing and transition activities. We are obligated to reimburse development costs incurred by the Licensors in connection with the ongoing studies, subject to an aggregate funding cap of $40.0 million and specified cumulative annual and quarterly funding caps through 2029. The related costs are recognized as research and development expense as the related services are performed. During the three and six months ended June 30, 2026, we recognized $1.5 million of research and development expense related to these activities.
Current report
We also agreed to purchase certain drug product inventories from Pfizer pursuant to a manufacturing and supply agreement.
Current report
Commercialized Products
Current report
VEPPANU/Vepdegestrant in ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer
Current report
VEPPANU overview
Current report
Breast cancer is the most commonly diagnosed cancer among women in the US. Approximately 70% of breast cancers are ER+. Patients with ER+/HER2- locally advanced or metastatic breast cancer are commonly treated with endocrine-based therapies, often in combination with targeted agents such as CDK4/6 inhibitors. Despite available therapies, disease progression is common, and treatment options following progression remain limited. Published data indicate that up to approximately 50% of patients with ER+/HER2- metastatic breast cancer may develop an ESR1 mutation following exposure to endocrine therapy. As a result, we believe there is a meaningful unmet medical need for patients whose disease progresses after prior endocrine-based treatment.
Current report
Based on published epidemiology and our assessment of the treatment landscape, we estimate that approximately 20,000 patients in the US with second line- or third-line ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer may be candidates for therapies targeting this patient population. Our estimates of the addressable patient population are based on published literature, epidemiological data, market research and internal analyses, and actual patient numbers may differ from these estimates. Given the significant prevalence of ER+/HER2- breast cancer and the limited treatment options available following progression on prior endocrine therapies, we believe VEPPANU has the potential to address a substantial patient population and represents a significant commercial opportunity in the US.
Current report
On May 1, 2026, VEPPANU (vepdegestrant) was approved by the FDA for the treatment of adults with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. FDA approval was granted based on data from VERITAC-2 clinical trial that evaluated vepdegestrant versus fulvestrant in patients with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer. In the trial, among patients with an ESR1 mutation (n=270), vepdegestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 43% compared to fulvestrant. Median PFS was 5.0 months (95% CI: 3.7, 7.4) in the vepdegestrant arm and 2.1 months (95% CI: 1.9, 3.5) in the fulvestrant arm (hazard ratio 0.57 (95% CI: 0.42, 0.77); p-value 0.0001). Overall survival was immature with 16% of deaths in this population at the time of the PFS analysis. The majority of adverse events with vepdegestrant were low grade (Grade 1-2) and the most common (≥10%) adverse reactions, including laboratory abnormalities, were decreased white blood cells, increased AST, musculoskeletal pain, fatigue, decreased hemoglobin, decreased neutrophils, increased ALT, increased alkaline phosphatase, nausea, decreased blood potassium, increased bilirubin, decreased appetite, electrocardiogram QT prolonged, decreased platelets, and constipation.
Current report
VEPPANU is the first and only FDA-approved oral PROTAC. PROTACs are part of a new class of heterobifunctional protein degraders designed to harness the body's natural machinery to selectively degrade, rather than inhibit, disease-causing proteins.
Current report
Vepdegestrant was discovered by Arvinas using its PROTAC protein degradation platform and co-developed by Arvinas and Pfizer under a global collaboration. We obtained rights to vepdegestrant pursuant to the license agreement with Arvinas and Pfizer entered in May 2026.
Current report
Vepdegestrant is covered by issued composition of matter patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (referred to as the “Orange Book”), with expiration dates beginning in 2037 (2038 for one patent including patent term adjustment), in each case subject to any applicable patent term extensions. We have filed applications for patent term extension for the Orange Book-listed patents, one of which, if granted, is expected to extend patent protection until May 2040. In addition to the composition of matter patents, issued patents and pending patent applications in the US and other jurisdictions cover, among other things, formulations, methods of use, dosing, polymorphs and manufacturing. Additional patent families, if issued, are expected to provide patent protection extending from 2040 through 2046.
Current report
On May 8, 2026, the NCCN added vepdegestrant to the latest NCCN Guidelines for Breast Cancer. Vepdegestrant was added as a Category 2A treatment option for patients with hormone receptor (HR)-positive/HER2-negative, ESR1-mutated advanced or metastatic breast cancer after at least one line of endocrine therapy + CDK4/6 inhibitor.
Current report
Competitive landscape for vepdegestrant
Current report
VEPPANU competes with currently approved therapies for ER+/HER2- metastatic breast cancer, including endocrine therapies and selective estrogen receptor degraders (SERDs) such as fulvestrant, elacestrant (Menarini Group/Stemline Therapeutics, Inc.), imlunestrant (Lilly), and investigational agents like camizestrant (AstraZeneca) and giredestrant (Roche/Genentech).
Current report
In addition, several investigational agents, including oral SERDs such as camizestrant and giredestrant, are in late-stage clinical development and may represent future competition. The commercial success of vepdegestrant will depend on a number of factors, including efficacy, safety profile, physician and patient acceptance, pricing, reimbursement, competitive products and market access.
Current report
VEPPANU commercial activities, including sales and marketing
Current report
We expect VEPPANU to become commercially available in mid-August 2026. We plan to leverage our existing commercial infrastructure to support its commercialization and will distribute and market VEPPANU for its FDA-approved indication in adults with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer.
Current report
TAVALISSE net product sales for the three and six months ended June 30, 2026 were $47.4 million and $84.7 million, respectively, an increase of 18% and 24%, respectively, compared to $40.1 million and $68.5 million for the three and six months ended June 30, 2025, respectively. The increase was primarily driven by higher volumes and higher price per bottle, as well as a favorable impact from lower revenue reserves.
Current report
REZLIDHIA net product sales for the three and six months ended June 30, 2026 were $8.9 million and $17.0 million, respectively, an increase of 27% and 29%, respectively, compared to $7.0 million and $13.1 million for the three and six months ended June 30, 2025, respectively. The increase was primarily driven by higher volumes and higher price per bottle, partially offset byhigher revenue reserves.
Current report
GAVRETO net product sales for the three and six months ended June 30, 2026 were $10.7 million and $20.3 million, respectively, a decrease of 10% and 2%, respectively, compared to $11.8 million and $20.8 million for the three and six months ended June 30, 2025, respectively. The decrease was primarily driven by lower volumes and higher revenue reserves, partially offset by higher price per bottle.
Current report
Contract revenues from collaborations and other for the three and six months ended June 30, 2025 primarily consisted of $40.0 million of non-cash revenue related to the release of cost share liability from our collaboration with Lilly. In addition, for the three and six months ended June 30, 2025, contract revenues from collaborations and other includes revenue from Grifols of $2.0 million and $6.7 million, respectively, related to royalties and delivery of drug supplies; revenue from Kissei of $0.4 million and $5.1 million, respectively, related to delivery of drug supplies and a milestone payment in the first quarter of 2025; and revenue from Medison of $0.2 million and $0.6 million, respectively, related to royalties and delivery of drug supplies.
Current report
The increase in selling, general and administrative expense in the three and six months ended June 30, 2026 compared to the same period in 2025 was primarily due to increased personnel-related costs of $2.6 million and $4.2 million, respectively, primarily driven by higher stock-based compensation expense and other employee-related costs; increases in third-party costs andother selling, general and administrative expenses of $0.8 million and $0.6 million, respectively, primarily related to timing of spending on professional services and other general corporate support activities; and higher commercial-related expenses of $1.5 million for the six months ended June 30, 2026, primarily due to the timing of commercial activities. Commercial-related expenses were relatively flat for the three months ended June 30, 2026 compared to the same period in 2025.
Current report
As discussed in “Note 5 – In-licensing and Acquisition” to our “Notes to Condensed Financial Statements” included in Part I, Item 1 of this Quarterly Report on Form 10-Q, pursuant to our license agreement with Arvinas and Pfizer, we may be required to make certain additional payments, including license fees payable upon the successful completion of certain transition activities, regulatory and commercial milestone payments, royalties on net sales, as well as payments related to sublicensing arrangements.
Removed paragraphs (6)
Previous report
Commercial Products
Previous report
GAVRETO net product sales for the three months ended March 31, 2026 were $9.6 million, an increase of $0.6 million, or 7%, compared to $9.0 million for the same period in 2025. The increase was primarily driven by higher price per bottle and, to a lesser extent, higher volumes.
Previous report
Commercial Products
Previous report
^ Decrease for Optime Care, Inc. was due to change in distribution channel
Previous report
TAVALISSE net product sales for the three months ended March 31, 2026 were $37.3 million, an increase of 31%, compared to $28.5 million for the three months ended March 31, 2025. The increase was primarily driven by higher volumes and higher price per bottle, as well as a favorable impact from lower revenue reserves. REZLIDHIA net product sales for the three months ended March 31, 2026 were $8.0 million, an increase of 31%, compared to $6.1 million for the three months ended March 31, 2025. The increase was primarily driven by higher volumes and higher price per bottle, partially offset byhigher revenue reserves. GAVRETO net product sales for the three months ended March 31, 2026 were $9.6 million, an increase of 7%, compared to $9.0 million for the three months ended March 31, 2025. The increase was primarily driven by higher price per bottle and, to a lesser extent, higher volumes
Previous report
The increase in selling, general and administrative expense in the three months ended March 31, 2026 compared to the same period in 2025 was primarily due to a $1.6 million increase in commercial related expenses and a $1.7 million increase in personnel-related costs. These increases were partially offset by decrease in various sales, general and administrative expenses of $0.4 million.
Reworded paragraphs (35)
Previous wording
This discussion and analysis should be read in conjunction with our financial statements and the accompanying notes included in this report and the audited financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 3, 2026. Our financial results for the three months ended March 31, 2026 are not necessarily indicative of results that may occur in future interim periods or for the full fiscal year.
Current wording
This discussion and analysis should be read in conjunction with our financial statements and the accompanying notes included in this report and the audited financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 3, 2026. Our financial results for the three and six months ended June 30, 2026 are not necessarily indicative of results that may occur in future interim periods or for the full fiscal year.
Previous wording
This Quarterly Report on Form 10-Q contains statements indicating expectations about future performance and other forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (Exchange Act), and the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. We usually use words such as “may,” “will,” “would,” “should,” “could,” “expect,” “plan,” “anticipate,” “might,” “believe,” “estimate,” “predict,” “intend,” or the negative of these terms or similar expressions to identify these forward-looking statements. These statements appear throughout this Quarterly Report on Form 10-Q and are statements regarding our current expectations, beliefs or intent, primarily with respect to our operations and related industry developments. Examples of these statements include, but are not limited to: our business and scientific strategies; risks and uncertainties associated with the commercialization, distribution, marketing, and payment for our products in the US and outside the US; risks that the FDA, EMA, the Medicines and Health Products Regulatory Agency (MHRA) or other regulatory authorities may make adverse decisions regarding our products; the impact of the US federal government shutdowns or agency funding disruptions; the progress of our and our collaborators’ product development programs, including clinical testing, and the timing of results thereof; our corporate collaborations and revenues that may be received from our collaborations and the timing of those potential payments; our expectations with respect to obligations to entities party to commercial or licensing agreements with us and the timing of those obligations; our expectations with respect to timing of recognizing product sales; our expectations with respect to the volume of product sales; our expectations with respect to regulatory submissions and approvals; our drug discovery technologies; our research and development expense; protection of our intellectual property and our intention to vigorously enforce our intellectual property rights; the availability and sufficiency of our cash and capital resources and the need for additional capital; our ability to successfully identify and acquire or in-license products or companies; our operations and legal risks; and the effectiveness of our cybersecurity risk management process. You should not place undue reliance on these forward-looking statements. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including as a result of the risks and uncertainties discussed under the heading “Risk Factors” in Item 1A of Part II of this Quarterly Report on Form 10-Q. Any forward-looking statement speaks only as of the date on which it is made, and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which t…
Excerpt shortened here; the source contains the full paragraph.
Current wording
This Quarterly Report on Form 10-Q contains statements indicating expectations about future performance and other forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (Exchange Act), and the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. We usually use words such as “may,” “will,” “would,” “should,” “could,” “expect,” “plan,” “anticipate,” “might,” “believe,” “estimate,” “predict,” “intend,” or the negative of these terms or similar expressions to identify these forward-looking statements. These statements appear throughout this Quarterly Report on Form 10-Q and are statements regarding our current expectations, beliefs or intent, primarily with respect to our operations and related industry developments. Examples of these statements include, but are not limited to: our business and scientific strategies; risks and uncertainties associated with the commercialization, distribution, marketing, and payment for our products in the US and outside the US; risks that the FDA, EMA, the Medicines and Health Products Regulatory Agency (MHRA) or other regulatory authorities may make adverse decisions regarding our products; the impact of the US federal government shutdowns or agency funding disruptions; the progress of our and our collaborators’ product development programs, including clinical testing, and the timing of results thereof; our corporate collaborations and revenues that may be received from our collaborations and the timing of those potential payments; our expectations with respect to obligations to entities party to commercial or licensing agreements with us and the timing of those obligations; our expectations with respect to timing of recognizing product sales; our expectations with respect to the volume of product sales; the anticipated commercial launch and commercialization of VEPPANU; our expectations with respect to potential patient populations; our expectations with respect to regulatory submissions and approvals; our drug discovery technologies; our research and development expense; protection of our intellectual property and our intention to vigorously enforce our intellectual property rights; the availability and sufficiency of our cash and capital resources and the need for additional capital; our ability to successfully identify and acquire or in-license products or companies; our operations and legal risks; and the effectiveness of our cybersecurity risk management process. You should not place undue reliance on these forward-looking statements. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including as a result of the risks and uncertainties discussed under the heading “Risk Factors” in Item 1A of Part II of this Quarterly Report on Form 10-Q. Any forward-looking statement speaks only as of the date on which it is made,…
Excerpt shortened here; the source contains the full paragraph.
Previous wording
GAVRETO (pralsetinib) is our third FDA-approved product which we began commercializing in June 2024. GAVRETO is a once daily, small molecule, oral, kinase inhibitor of wild-type RET and oncogenic RET fusions. GAVRETO is approved by the FDA for the treatment of adult patients with metastatic RET fusion-positive NSCLC as detected by an FDA-approved test. GAVRETO is also approved under accelerated approval based on overall response rate and duration response rate, for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). We acquired the rights to research, develop, manufacture and commercialize GAVRETO in the US from Blueprint pursuant to an asset purchase agreement entered in February 2024.
Current wording
GAVRETO (pralsetinib) is our third FDA-approved product which we began commercializing in June 2024. GAVRETO is a once daily, small molecule, oral, kinase inhibitor of wild-type RET and oncogenic RET fusions. GAVRETO is approved by the FDA for the treatment of adult patients with metastatic RET fusion-positive NSCLC as detected by an FDA-approved test. GAVRETO is also approved under accelerated approval based on overall response rate and duration response, for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). We acquired the rights to research, develop, manufacture and commercialize GAVRETO in the US from Blueprint pursuant to an asset purchase agreement entered in February 2024.
Previous wording
Our development pipeline includes R289, our dual IRAK1/4 inhibitor program, which is being advanced in an open-label, Phase 1b study to determine the safety, tolerability and preliminary efficacy of the drug in patients with lower-risk MDS who are relapsed, refractory or resistant to prior therapies.
Current wording
Our development pipeline includes R289, our dual IRAK1/4 inhibitor, which is being advanced in an open-label, Phase 1b study to determine the safety, tolerability and preliminary efficacy of the drug in patients with lower-risk MDS who are relapsed, refractory or resistant to prior therapies.
Previous wording
TAVALISSE net product sales for the three months ended March 31, 2026 were $37.3 million, an increase of $8.8 million, or 31%, compared to $28.5 million for the same period in 2025. The increase was primarily driven by higher volumes and higher price per bottle, as well as a favorable impact from lower revenue reserves.
Current wording
TAVALISSE net product sales for the six months ended June 30, 2026 were $84.7 million, an increase of $16.1 million, or 24%, compared to $68.5 million for the same period in 2025. The increase was primarily driven by higher volumes and higher price per bottle, as well as a favorable impact from lower revenue reserves.
Previous wording
REZLIDHIA net product sales for thethree months ended March 31, 2026 were$8.0 million, an increase of$1.9 million, or 31%, compared to$6.1 million for the same period in 2025. The increase was primarily driven by higher volumes and higher price per bottle, partially offset byhigher revenue reserves.
Current wording
REZLIDHIA net product sales for thesix months ended June 30, 2026 were$17.0 million, an increase of$3.8 million, or 29%, compared to$13.1 million for the same period in 2025. The increase was primarily driven by higher volumes and higher price per bottle, partially offset byhigher revenue reserves.
Previous wording
We have a Strategic Collaboration Agreement with MDACC, a comprehensive cancer research, treatment, and prevention center. The collaboration expanded our evaluation of olutasidenib in AML and other hematologic cancers with IDH1 mutations. Under the Strategic Collaboration Agreement, we jointly lead the clinical development efforts with MDACC to evaluate the potential of olutasidenib to treat newly diagnosed and R/R patients with AML, higher-risk MDS, and advanced myeloproliferative neoplasms, in combination with other agents. The collaboration also supports the evaluation of olutasidenib as monotherapy in patients with IDH1 mutated clonal cytopenia of undetermined significance (CCUS) and lower-risk MDS, as well as maintenance therapy following hematopoietic stem cell transplant. Further, this collaboration also supports the evaluation of olutasidenib in combination with co-targeted therapies in patients with R/RIDH1-mutated myeloid malignancies harboring activated signaling pathway mutations. There are five studies open for enrollment associated with the multi-year strategic development alliance. Under the Strategic Collaboration Agreement, we will provide MDACC the study materials and $15.0 million in time-based milestone payments as compensation for services to be provided for the studies, over the five-year collaboration term, unless terminated earlier as provided for in the agreement. Through March 31, 2026, we provided $5.3 million funding to MDACC.
Current wording
We have a Strategic Collaboration Agreement with MDACC, a comprehensive cancer research, treatment, and prevention center. The collaboration expanded our evaluation of olutasidenib in AML and other hematologic cancers with IDH1 mutations. Under the Strategic Collaboration Agreement, we jointly lead the clinical development efforts with MDACC to evaluate the potential of olutasidenib to treat newly diagnosed and R/R patients with AML and advanced myeloproliferative neoplasms, in combination with other agents. The collaboration also supports the evaluation of olutasidenib as monotherapy in patients with IDH1 mutated clonal cytopenia of undetermined significance (CCUS) and lower-risk MDS, as well as maintenance therapy following hematopoietic stem cell transplant. Further, this collaboration also supports the evaluation of olutasidenib in combination with co-targeted therapies in patients with R/RIDH1-mutated myeloid malignancies harboring activated signaling pathway mutations. The multi-year strategic development alliance continues to support multiple ongoing clinical studies that are open for enrollment. Under the Strategic Collaboration Agreement, we are obligated to provide study materials and up to $15.0 million in time-based milestone payments as compensation for services to be provided for the studies, over the five-year collaboration term, unless terminated earlier as provided for in the agreement. Through June 30, 2026, we provided $5.3 million funding to MDACC.
Previous wording
On April 16, 2026, we received written notice from Lilly of its decision to terminate the Lilly Agreement, which will become effective June 15, 2026. Following termination of the Lilly Agreement, including the prior termination of the CNS disease program effective in November 2025, we do not expect to receive future milestones or royalties under the Lilly Agreement. Pursuant to such termination, the Lilly Agreement will terminate in accordance with its terms, including the cessation of Lilly’s rights to the licensed compounds, subject to any applicable transition provisions. We expect to regain full rights to the licensed compounds and related programs upon termination.
Current wording
On April 16, 2026, we received a written notice from Lilly of its decision to terminate the Lilly Agreement, which became effective June 15, 2026. Following termination, the rights previously licensed to Lilly under the Lilly Agreement reverted to us in accordance with the terms of the Lilly Agreement, and we do not expect to receive any future milestone payments or royalties thereunder.
Previous wording
On May 5, 2026, we terminated our Credit Agreement with MidCap, which provided for a $60.0 million term loan facility, under which$45.0 million was outstanding as of March 31, 2026, and repaid all outstanding borrowings thereunder, including applicable fees and expenses. Concurrently, we entered into a new Credit Agreement with MidCap, which provides for a revolving credit facility with an initial borrowing capacity of $40.0 million and an option to increase to $60.0 million, subject to customary conditions. Availability under the revolving credit facility is subject to a borrowing base based primarily on eligible accounts receivable and inventory. The revolving credit facility under the new Credit Agreement has a five-year term and bears interest at a rate equal to one-month SOFR, subject to a 2.00% floor, plus an applicable margin of 4.00%. The obligations under the revolving credit facility are secured by a first-priority security interest in substantially all of our assets, including our intellectual property. The revolving credit facility includes customary fees, including an unused commitment fee, administrative fee and prepayment premiums during the initial period. As of the date of this filing, we had an outstanding borrowing of $8.0 million under the revolving credit facility.
Current wording
On May 5, 2026, we terminated our Credit Agreement with MidCap, which provided for a $60.0 million term loan facility and repaid all outstanding borrowings thereunder, including applicable fees and expenses. Concurrently, we entered into a new Credit Agreement with MidCap, which provides for a revolving credit facility with an initial borrowing capacity of $40.0 million and an option to increase to $60.0 million, subject to customary conditions. Availability under the revolving credit facility is subject to a borrowing base based primarily on eligible accounts receivable and inventory. The revolving credit facility under the new Credit Agreement has a five-year term and bears interest at a rate equal to one-month SOFR, subject to a 2.00% floor, plus an applicable margin of 4.00%. The obligations under the revolving credit facility are secured by a first-priority security interest in substantially all of our assets, including our intellectual property. The revolving credit facility includes customary fees, including an unused commitment fee, administrative fee and prepayment premiums during the initial period. At June 30, 2026, we had an outstanding borrowing of $40.0 million under the revolving credit facility, consisting of an initial draw of $8.0 million following the execution of the new Credit Agreement in May 2026 and an additional draw of $32.0 million in June 2026. In July 2026, we repaid $32.0 million of the outstanding borrowings under the revolving credit facility. Following the repayment, $8.0 million remained outstanding under the facility.
Previous wording
We have a commercial license agreement with Knight under which Knight hasexclusivity rights to commercialize fostamatinib for approved indications in Latin America, consisting of Mexico, Central and South America, and the Caribbean, and we are responsible for the exclusive manufacture and supply of fostamatinib for all development and commercialization activities under a related supply agreement. Knight submitted Marketing Authorization Applications (MAAs) in Mexico, Colombia, Brazil, Argentina and Paraguay for fostamatinib for the treatment of adult patients with chronic ITP who had insufficient response to a previous treatment. In December 2024, Knight announced that TAVALISSE was approved in Mexico for this indication.
Current wording
We have a commercial license agreement with Knight under which Knight hasexclusivity rights to commercialize fostamatinib for approved indications in Latin America, consisting of Mexico, Central and South America, and the Caribbean, and we are responsible for the exclusive manufacture and supply of fostamatinib for all development and commercialization activities under a related supply agreement. Knight submitted MAAs in Mexico, Colombia, Brazil, Argentina and Paraguay for fostamatinib for the treatment of adult patients with chronic ITP who had insufficient response to a previous treatment. In December 2024, Knight announced that TAVALISSE was approved in Mexico for this indication, and Knight commercially launched TAVALISSE in Mexico in May 2026. In May 2026, Knight announced that Brazil's Agência Nacional de Vigilância Sanitária (ANVISA) approved TAVALISSE for the same indication.
Previous wording
We began our commercialization and started recognizing revenue from product sales of GAVRETO in June 2024. We believe GAVRETO is highly synergistic with our current product portfolio, and we expect to continue to leverage our existing commercial infrastructure to ensure current and newly prescribed GAVRETO patients have continued access to this important treatment option. We distribute and market GAVRETO for approved indications in RET fusion-positive NSCLC and advanced thyroid cancers.
Current wording
We began our commercialization and started recognizing revenue from product sales of GAVRETO in June 2024. We distribute and market GAVRETO for approved indications in RET fusion-positive NSCLC and advanced thyroid cancers.
Previous wording
We have a strategic collaboration agreement with MDACC entered in December 2023, to expand our evaluation of olutasidenib in AML and other hematologic cancers with IDH1 mutations. Under such collaboration agreement, we will jointly lead the clinical development efforts with MDACC to evaluate the potential of olutasidenib to treat newly diagnosed and R/R patients with AML, higher-risk MDS, and advanced myeloproliferative neoplasms, in combination with other agents. The collaboration will also support the evaluation of olutasidenib as monotherapy in patients with IDH1 mutated CCUS and lower-risk MDS, as well as maintenance therapy following hematopoietic stem cell transplant. Five studies in the multi-year strategic development alliance are open for enrollment. The five studies include, (i)a Phase 1b/2 triplet therapy trial of decitabine and venetoclax in combination with olutasidenib in patients with m IDH1 AML. The Phase 1b part of the trial seeks to determine the safety and tolerability and recommended Phase 2 dose of decitabine and venetoclax in combination with olutasidenib; (ii)a Phase 2 study in patients with IDH1-mutated CCUS, lower-risk MDS and chronic myelomonocytic leukemia (CMML); (iii) a Phase 1/2 study of olutasidenib maintenance therapy following an allogeneic stem cell transplant for patients with IDH1-mutated myeloid malignancies; (iv) a Phase 2 study of olutasidenib in combination with hypomethylating agents (HMA) in patients with m IDH1 higher-risk myelodysplastic syndrome (HR-MDS)/ CMML or advanced myeloproliferative neoplasms; and (v) a Phase 2 multi-arm, multi-center, open-label, non-randomized clinical study will evaluate olutasidenib in combination with co-targeted therapies in patients with R/RIDH1-mutated myeloid malignancies harboring activated signaling pathway mutations.
Current wording
We have a strategic collaboration agreement with MDACC entered in December 2023, to expand our evaluation of olutasidenib in AML and other hematologic cancers with IDH1 mutations. Under such collaboration agreement, we will jointly lead the clinical development efforts with MDACC to evaluate the potential of olutasidenib to treat newly diagnosed and R/R patients with AML and advanced myeloproliferative neoplasms, in combination with other agents. The collaboration will also support the evaluation of olutasidenib as monotherapy in patients with IDH1 mutated CCUS and lower-risk MDS, as well as maintenance therapy following hematopoietic stem cell transplant. The multi-year strategic development alliance continues to support multiple ongoing clinical studies that are open for enrollment. The studies that are currently open for enrollment include: (i)a Phase 1b/2 triplet therapy trial of decitabine and venetoclax in combination with olutasidenib in patients with m IDH1 AML; (ii) a Phase 2 study in patients with IDH1-mutated CCUS, lower-risk MDS and chronic myelomonocytic leukemia (CMML); (iii) a Phase 1/2 study of olutasidenib maintenance therapy following an allogeneic stem cell transplant for patients with IDH1-mutated myeloid malignancies; and(iv) a Phase 2 multi-arm, multi-center, open-label, non-randomized clinical study will evaluate olutasidenib in combination with co-targeted therapies in patients with R/RIDH1-mutated myeloid malignancies harboring activated signaling pathway mutations.
Previous wording
Revenue from product sales is related to our sale of our products in the US, net of chargebacks, discounts and fees, government and other rebates and returns. Typically, our first quarter net sales are impacted by the first quarter reimbursement issues such as the resetting of deductibles, co-pays, and other access delays for Medicare patients with plan changes that take effect in January. Consistent with this pattern, our first quarter 2026 net product sales reflected the impact of these seasonal factors, which primarily affected January and February volumes. We observed improving demands through the quarter, with March showing stronger prescription volumes across our product portfolio.
Current wording
Revenue from product sales is related to our sale of our products in the US, net of chargebacks, discounts and fees, government and other rebates and returns. Typically, our first quarter net sales are impacted by the first quarter reimbursement issues such as the resetting of deductibles, co-pays, and other access delays for Medicare patients with plan changes that take effect in January. Consistent with this pattern, our first quarter 2026 net product sales reflected the impact of these seasonal factors, which primarily affected volumes earlier in the year. During the second quarter of 2026, we observed improved trends across our product portfolio compared to the first quarter, as the impact of these seasonal access-related factors moderated.
Previous wording
Contract revenues from collaborations for the three months ended March 31, 2026 and 2025 was primarily of revenue from Grifols, Kissei and Medison. Revenue from Grifols was $1.8 million and $4.7 million for the three months ended March 31, 2026 and 2025, respectively, consisting entirely of royalties in 2026 and, in 2025, both royalties and delivery of drug supplies. Revenue from Kissei was $1.8 million and $4.6 million, respectively for the three months ended March 31, 2026 and 2025, respectively, consisting entirely of delivery of drug supplies in 2026 and, in 2025, both delivery of drug supply and a$3.0 million milestone payment recognized in connection with theapproval of fostamatinib in Korea. Revenue from Medison was$0.3 million and $0.4 million for the three months ended March 31, 2026 and 2025, respectively, consisting of royalties and delivery of drug supplies.
Current wording
Contract revenues from collaborations and other for the three and six months ended June 30, 2026 consisted primarily of revenue from Kissei of $5.8 million and $7.6 million, respectively, related to a milestone payment and sublicense revenue recognized in the second quarter of 2026, and the delivery of drug supplies; revenue from Grifols of $5.0 million and $6.8 million, respectively, related to royalties and delivery of drug supplies; and revenue from Medison of $0.3 million and $0.5 million, respectively, related to royalties and delivery of drug supplies.
Previous wording
We expect that revenue from product sales to increase in the coming quarters due to moving past the seasonal reimbursement issues, as well as continued execution of our commercial strategy. However, net product sales may be impacted by the demand from our customers, changes to government and private payor rebate programs, chargeback and discount programs, co-payment assistance programs, and any other rebate and discount programs we may enter in the future. In addition, our future revenues may include payments from our existing and new collaboration partnersand government grants. As of March 31, 2026, we had$1.4 million of deferred revenue relating to our collaboration agreement with Kissei which we will recognize as revenue upon satisfaction of our remaining performance obligations.
Current wording
We expect that revenue from product sales to increase in the coming quarters due to moving past the seasonal reimbursement issues, continued execution of our commercial strategy, as well as the anticipated commercial launch of VEPPANU in August 2026. However, net product sales may be impacted by the demand from our customers, changes to government and private payor rebate programs, chargeback and discount programs, co-payment assistance programs, and any other rebate and discount programs we may enter in the future. In addition, our future revenues may include payments from our existing and new collaboration partnersand government grants.
Previous wording
The increase in cost of product sales for the three months ended March 31, 2026, compared to the same period in 2025, was primarily driven by higher royalties of $0.5 million. This increase was partially offset by a $0.3 million decrease in product costs, primarily due to the timing of drug supply deliveries to collaboration partners, partially offset by higher product costs associated with increased product sales.
Current wording
The increase in cost of product sales for the three and six months ended June 30, 2026, compared to the same period in 2025, was primarily driven by increase in product costs of $2.6 million and $2.4 million, respectively, primarily due to the timing of drug supply deliveries to collaboration partners and higher product costs associated with increased product sales, as well as higher royalties of $1.1 million, and $1.6 million, respectively.
Previous wording
The increase in research and development expense in the three months ended March 31, 2026 compared to the same period in 2025, was primarily due to increased clinical trial related expenses of $2.6 million resulting from the timing of clinical development programs, including the progress activities on our ongoing IRAK1/4 inhibitor program, and increase in other various research and development expenses of $0.7 million .
Current wording
The increase in research and development expense in the three and six months ended June 30, 2026 compared to the same period in 2025, was primarily due to increased clinical trial related expenses of $2.7 million and $5.2 million, respectively, driven by the timing of clinical development programs, including the progress of activities on our ongoing IRAK1/4 inhibitor program; increased personnel related costs of $2.4 million and $2.2 million, respectively, primarily due to higher stock-based compensation expense and other employee-related costs; $1.5 million for both the three and six months ended June 30, 2026 of research and development expense related to reimbursable development costs under our license agreement with Arvinas and Pfizer; and increases of $0.6 million and $1.4 million, respectively, in other various research and development expenses.
Previous wording
Our research and development expenditures include costs related to preclinical and clinical trials, scientific personnel, supplies, equipment, consultants, sponsored research, stock-based compensation, and allocated facility costs. We expect to continue to incur significant research and development expense as we continue our activities in our clinical studies including IRAK1/4 inhibitor program; our collaborative partnerships with MDACC and CONNECTto conduct evaluation of olutasidenib in other diseases areas with IDH1 mutations; and any other clinical programs we may pursue in the future.
Current wording
Our research and development expenditures include costs related to preclinical and clinical trials, scientific personnel, supplies, equipment, consultants, sponsored research, stock-based compensation, and allocated facility costs. We expect to continue to incur significant research and development expense as we continue our activities in our clinical studies including IRAK1/4 inhibitor program; our collaborative partnerships with MDACC and CONNECTto conduct evaluation of olutasidenib in other disease areas with IDH1 mutations; and any other clinical programs we may pursue in the future.
Previous wording
“Other” expenses in the three months ended March 31, 2026 and 2025 consisted of allocated facilities costs of $0.1 million and $0.1 million, respectively, andstock-based compensation expense of$0.4 million and$0.9 million, respectively.
Current wording
“Other” expenses in the three and six months ended June 30, 2026 consisted of allocated facilities costs of $0.1 million and $0.2 million, respectively, andstock-based compensation expense of$1.9 million and$2.3 million, respectively.“Other” expenses in the three and six months ended June 30, 2025 consisted of allocated facilities costs of $0.1 million and $0.2 million, respectively, andstock-based compensation expense of$0.5 million and$1.4 million, respectively.
Previous wording
Interest income reflects returns earned on our cash and investment holdings, while interest expense relates to borrowing costs on our outstanding term loans with MidCap. The increase in interest income for the three months ended March 31, 2026, compared to the same period in 2025, was primarily driven by higher average investment balances, partially offset by lower interest rates. The decrease in interest expense for the three months ended March 31, 2026, compared to the same period in 2025, was primarily due to scheduled principal payments that reduced our outstanding debt balance, as well as impact of lower interest rates.
Current wording
Interest income reflects returns earned on our cash and investment holdings, while interest expense relates to borrowing costs on our outstanding loans with MidCap. The increase in interest income for the three and six months ended June 30, 2026, compared to the same period in 2025, was primarily driven by higher average investment balances, partially offset by lower interest rates. The decrease in interest expense for the three and six months ended June 30, 2026, compared to the same period in 2025, was primarily due to reduced outstanding debt balance and impact of lower interest associated with the new revolving credit facility, partially offset by a loss on extinguishment attributable to the extinguished portion of the prior term loan.
Previous wording
The provision for income taxes for thethree months ended March 31, 2026 primarily consisted of federal income tax expense of$2.4 million and estimated state income taxes of$0.6 million. Prior to the fourth quarter of 2025, we maintained a full valuation allowance against our deferred tax assets. Although we do not expect to incur federal cash income taxes due to sufficient NOL and research and development credit carryforwards, we recognized federal income tax expense based on the estimated impact of utilizing the deferred tax assets associated with such carryforwards. The total tax expense differs from the amount computed at the federal statutory rate primarily due to certain non-deductible expenses and state income taxes.
Current wording
The provision for income taxes for thethree and six months ended June 30, 2026 primarily consisted of federal income tax expense of$5.3 million and $7.7 million, respectively, and estimated state income taxes of$1.0 million and $1.6 million, respectively. Prior to the fourth quarter of 2025, we maintained a full valuation allowance against our deferred tax assets. Although we do not expect to incur federal cash income taxes due to sufficient NOL and research and development credit carryforwards, we recognized federal income tax expense based on the estimated impact of utilizing the deferred tax assets associated with such carryforwards. The total tax expense differs from the amount computed at the federal statutory rate primarily due to certain non-deductible expenses and state income taxes.
Previous wording
For thethree months ended March 31, 2025, the provision for income taxes primarily consisted of estimated state income taxes. The tax expense differs from the amount computed at the federal statutory rate primarily due to the impact of the valuation allowance and state taxes.
Current wording
For thethree and six months ended June 30, 2025, the provision for income taxes primarily consisted of estimated state income taxes. The tax expense differs from the amount computed at the federal statutory rate primarily due to the impact of the valuation allowance and state taxes.
Previous wording
As of March 31, 2026 and December 31, 2025, we had approximately $146.7 million and $155.0 million, respectively, in cash, cash equivalents and short-term investments. We continue to maintain investment portfolios primarily in money market funds, US treasury bills, government-sponsored enterprise securities, corporate bonds and commercial paper. Cash in excess of immediate requirements is invested with a focus to liquidity and capital preservation. We view our investments portfolio as available-for-sale and are available for use in current operations. Wherever possible, we seek to minimize the potential effects of concentration and degrees of risk. We continue to monitor the impact of the changes in the conditions of the credit and financial markets on our investment portfolio and assess if future changes in our investment strategy are necessary.
Current wording
At June 30, 2026 and December 31, 2025, we had approximately $95.3 million and $155.0 million, respectively, in cash, cash equivalents and short-term investments. We continue to maintain investment portfolios primarily in money market funds, US treasury bills, government-sponsored enterprise securities, corporate bonds and commercial paper. Cash in excess of immediate requirements is invested with a focus on liquidity and capital preservation. We view our investments portfolio as available-for-sale and are available for use in current operations. Wherever possible, we seek to minimize the potential effects of concentration and degrees of risk. We continue to monitor the impact of the changes in the conditions of the credit and financial markets on our investment portfolio and assess if future changes in our investment strategy are necessary.
Previous wording
Net cash provided by operating activities for the three months ended March 31, 2026 reflected net income, adjusted for non-cash items, partially offset by net cash outflows from changes in working capital. These outflows were primarily driven by decreases in liabilities due to the timing of payments, increases in prepaid and other current assets mainly due to the timing of advance payments to contract manufacturers and higher inventory levels due to the timing of production build-up, partially offset by lower accounts receivable due to the timing of collections. In comparison, net cash used in operating activities for the three months ended March 31, 2025 reflected net income, adjusted for non-cash items, offset by net cash outflows from changes in working capital. These outflows were primarily driven by similar factors, including increases in prepaid and other current assets and decreases in liabilities, partially offset by lower inventory levels.
Current wording
Net cash provided by operating activities for the six months ended June 30, 2026 reflected net income, adjusted for non-cash items, partially offset by net cash outflows from changes in working capital. These outflows were primarily driven by increases in accounts receivable due to the timing of collections, higher inventory levels resulting from production build-up, and decreases in liabilities due to the timing of payments, partially offset by decreases in prepaid and other current assets resulting from the transfer of advance payments to contract manufacturers to inventory. In comparison, net cash provided by operating activities for the six months ended June 30, 2025 reflected net income, adjusted for non-cash items, partially offset by net cash outflows from changes in working capital. These outflows were primarily driven by increases in inventory due to production build-up and increases in prepaid and other current assets due to advance payments to contract manufacturers, partially offset by increases in liabilities due to the timing of payments.
Previous wording
Net cash used in investing activities for the three months ended March 31, 2026 and 2025 consisted of net purchases of short-term investments of $8.0 million and $10.6 million, respectively.
Current wording
Net cash provided by investing activities for the six months ended June 30, 2026 consisted of net maturities and sales of short-term investments of $79.8 million, partially offset by payments for acquisition of intangible assets of $70.3 million. In comparison, net cash used in investing activities for the six months ended June 30, 2025 comprised net purchases of short-term investments of $33.8 million.
Previous wording
Net cash used in financing activities for the three months ended March 31, 2026 consisted primarily of $7.5 million of principal payments of term loans and $3.7 million of repurchases of common stock in connection with employee tax withholding on RSU vesting, partially offset by $0.3 million of net proceeds from the issuance of common stock under equity plans. Net cash provided by financing activities for thethree months ended March 31, 2025 consisted of$0.5 million of net proceeds from issuance of common stock under equity plans.
Current wording
Net cash used in financing activities for the six months ended June 30, 2026 consisted primarily of the repayment of term loan and related fees of $55.3 million, payments of $4.3 million for repurchases of common stock in connection with employee tax withholding on RSU vesting, and $5.0 million payment of closing purchase price related to asset acquisition with Blueprint. These outflows were partially offset by the $39.7 million net proceeds from revolving facility and $2.2 million of net proceeds from the issuance of common stock under equity plans. In comparison, net cash provided by financing activities for thesix months ended June 30, 2025 consisted of$0.9 million of net proceeds from issuance of common stock under equity plans.
Previous wording
We believe that our existing capital resources will be sufficient to support our current and projected funding requirements, including the continued commercialization of our products, through at least the next 12 months from this Form 10-Q filing date. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with commercializing a product, the development of our product candidates and other research and development activities, we are unable to estimate with certainty our future product revenues, our revenues from our current and future collaborative partners, the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical trials and other research and development activities.
Current wording
We believe that our existing capital resources will be sufficient to support our current and projected funding requirements, including the continued commercialization of our products, through at least the next 12 months from this Form 10-Q filing date. This assessment includes our anticipated funding requirements related to VEPPANU, including planned commercialization and launch activities, transition activities under our license agreement with Arvinas and Pfizer, expected inventory purchases and our obligation to contribute toward certain ongoing development activities. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with commercializing a product, the development of our product candidates and other research and development activities, we are unable to estimate with certainty our future product revenues, our revenues from our current and future collaborative partners, the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical trials and other research and development activities.
Previous wording
Under our existing collaboration agreements entered in the ordinary course of business, we have received, and may in the future receive upfront cash payments, payments contingent upon the achievement of specified events by our partners, and royalties on net sales of products sold by such partners under the agreements. The total potential future contingent payments due to us under these agreements are approximately $657.1 million. This amount accounts for terminated programs and Lilly’s April 2026 notice to terminate the Lilly Agreement and assumes achievement of all applicable milestones under the existing agreements. The estimate excludes any potential royalties that may be payable to us if our partners successfully commercialize licensed products. Potential future milestone payments under these agreements are contingent solely upon our partners’ future efforts and the achievement of specified development, regulatory, and commercial milestones. See further discussion in “Note 4 – Sponsored Research and License Agreements” to our “Notes to Condensed Financial Statements” contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.
Current wording
Under our existing collaboration agreements entered in the ordinary course of business, we have received, and may in the future receive upfront cash payments, payments contingent upon the achievement of specified events by our partners, and royalties on net sales of products sold by such partners under the agreements. The total potential future contingent payments due to us under these agreements are approximately $652.1 million. This amount excludes terminated programs including the termination of the Lilly Agreement, and assumes achievement of all applicable milestones under the existing agreements. The estimate excludes any potential royalties that may be payable to us if our partners successfully commercialize licensed products. Potential future milestone payments under these agreements are contingent solely upon our partners’ future efforts and the achievement of specified development, regulatory, and commercial milestones. See further discussion in “Note 4 – Sponsored Research and License Agreements” to our “Notes to Condensed Financial Statements” contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.
Previous wording
We have an Open Market Sale Agreement with Jefferies LLC (Jefferies), as a sole agent, entered on August 4, 2020, and amended and restated on August 2, 2024. Pursuant to such Open Market Sale Agreement, we may sell from time to time, through Jefferies, shares of our common stock in sales deemed to be “at-the-market offerings” as defined in Rule 415 under the Securities Act, subject to conditions specified in the Open Market Sale Agreement, including maintaining an effective registration statement covering the sale of shares under the Open Market Sale Agreement. We have an active Registration Statement filed with the SEC, which registered, among other securities, a base prospectus which covers the offering, issuance, and sale by us of up to $250.0 million in the aggregate of the securities identified from time to time in one or more offerings, which include the $100.0 million of shares of our common stock that may be offered, issued and sold under the Open Market Sale Agreement. As of March 31, 2026, we have not sold any shares of common stock under such Open Market Sale Agreement.
Current wording
We have an Open Market Sale Agreement with Jefferies LLC (Jefferies), as a sole agent, entered on August 4, 2020, and amended and restated on August 2, 2024. Pursuant to such Open Market Sale Agreement, we may sell from time to time, through Jefferies, shares of our common stock in sales deemed to be “at-the-market offerings” as defined in Rule 415 under the Securities Act, subject to conditions specified in the Open Market Sale Agreement, including maintaining an effective registration statement covering the sale of shares under the Open Market Sale Agreement. We have an active Registration Statement filed with the SEC, which registered, among other securities, a base prospectus which covers the offering, issuance, and sale by us of up to $250.0 million in the aggregate of the securities identified from time to time in one or more offerings, which include the $100.0 million of shares of our common stock that may be offered, issued and sold under the Open Market Sale Agreement. At June 30, 2026, we have not sold any shares of common stock under such Open Market Sale Agreement.
Previous wording
We have a Credit Agreement with MidCap that provided for$60.0 million term loan credit facility, under which$45.0 million was outstanding as of March 31, 2026. On May 5, 2026, we terminated the Credit Agreement and repaid all outstanding borrowings thereunder, including applicable prepayment premiums, accrued interest and final payment fees, using cash on hand. Concurrently, we entered into a new Credit Agreement with MidCap, which provides for a revolving credit facility with a maximum borrowing capacity of $40.0 million, with an option to increase to $60.0 million, subject to customary conditions. Availability under the revolving credit facility is subject to a borrowing base based primarily on eligible accounts receivable and inventory. While the revolving credit facility enhances our financial flexibility to support operations and working capital needs, our liquidity is dependent on the level of borrowing base availability. As of the date of this filing, we had an outstanding borrowing of $8.0 million under the revolving credit facility.
Current wording
We had a Credit Agreement with MidCap that provided for$60.0 million term loan credit facility. On May 5, 2026, we terminated the term loan credit facility and repaid all outstanding borrowings therein, including the applicable prepayment premiums, accrued interest and final payment fees, using cash on hand. Concurrently, we entered into a new Credit Agreement with MidCap, which provides for a revolving credit facility with a maximum borrowing capacity of $40.0 million, with an option to increase to $60.0 million, subject to customary conditions. Availability under the revolving credit facility is subject to a borrowing base based primarily on eligible accounts receivable and inventory. While the revolving credit facility enhances our financial flexibility to support operations and working capital needs, our liquidity is dependent on the level of borrowing base availability. At June 30, 2026, we had an outstanding borrowing of $40.0 million under the revolving credit facility, consisting of an initial draw of $8.0 million following the execution of the new Credit Agreement in May 2026 and an additional draw of $32.0 million in June 2026. In July, 2026, we repaid $32.0 million of the outstanding borrowings under the revolving credit facility. Following the repayment, $8.0 million remained outstanding under the facility. We may borrow or repay amounts under the facility from time to time based on our operating needs, working capital requirements, cash management objectives and overall liquidity planning. Accordingly, our outstanding borrowings and related cash balances may vary during a reporting period, and period-end balances may not be indicative of balances at other times during the period.
Previous wording
In the ordinary course of business, we enter into agreements with contract manufacturers to manufacture our inventory products. These agreements generally include termination provisions that may require us to pay cancellation fees, which vary depending on the timing of termination and may equal up to the full value of the work order. In October 2024, we entered into an agreement with a third-party contract manufacturer to manufacture TAVALISSE, with deliveries expected from 2026 through 2029. As of March 31, 2026, the contractual obligation not included in our financial statements related to an agreement that may potentially be subjected to cancellation fees were approximately $19.2 million, of which, $5.4 million is expected to be due in the remainder of 2026, and $9.5 million is expected to be due in 2027 and 2028. As of March 31, 2026, we have not incurred any cancellation fees under our agreements with contract manufacturers.
Current wording
In the ordinary course of business, we enter into agreements with contract manufacturers to manufacture our inventory products. These agreements generally include termination provisions that may require us to pay cancellation fees, which vary depending on the timing of termination and may equal up to the full value of the work order. In October 2024, we entered into an agreement with a third-party contract manufacturer to manufacture TAVALISSE, with deliveries expected from 2026 through 2029. At June 30, 2026, the contractual obligation not included in our financial statements related to an agreement that may potentially be subjected to cancellation fees were approximately $16.3 million, of which, $2.5 million is expected to be due in the remainder of 2026, and $9.5 million is expected to be due in 2027 and 2028. At June 30, 2026, we have not incurred any cancellation fees under our agreements with contract manufacturers. In addition, as contemplated by the license agreement with Arvinas and Pfizer, in July 2026, we entered into a manufacturing and supply agreement with Pfizer for the commercial manufacture and supply of VEPPANU. The agreement includes certain minimum purchase obligations on a take-or-pay basis, with expected purchases from 2026 through 2030. If we do not satisfy the applicable minimum purchase commitments within the required time periods, we may be required to make payments to Pfizer with respect to those commitments, as provided in the agreement. The estimated contractual obligation not included in our financial statements related to this agreement was approximately $26.8 million. Of this amount, approximately $4.6 million is expected to be due in the remainder of 2026 and $11.0 million is expected to be due in 2027 and 2028, with the remaining amount expected to be due thereafter through 2030.
Previous wording
Also, as discussed in detail in “Note 5 – In-licensing and Acquisition” of our “Notes to Condensed Financial Statements” contained in Part I, Item 1 of this Quarterly Report on Form 10-Q, pursuant to our license and transition services agreement with Forma, Forma is entitled to potential development and regulatory milestone payments and tiered royalty payments on net sales as well as certain portion of sublicensing revenue. Further, following our olutasidenib sublicensing agreements with Kissei and Dr. Reddy’s, Forma is entitled to a portion of the sublicensing revenue we receive from Kissei and Dr. Reddy’s under such respective agreements.
Current wording
Also, as discussed in detail in “Note 5 – In-licensing and Acquisition” of our “Notes to Condensed Financial Statements” contained in Part I, Item 1 of this Quarterly Report on Form 10-Q, pursuant to our license and transition services agreement with Forma, Forma is entitled to potential development and regulatory milestone payments and tiered royalty payments on net sales as well as certain portion of sublicensing revenue. In connection with our sublicensing agreements with Kissei and Dr. Reddy’s, Forma is entitled to a portion of the sublicensing revenue we receive under those agreements.
Previous wording
Additionally, as discussed in detail in “Note 5 – In-licensing and Acquisition” of our “Notes to Condensed Financial Statements” contained in Part I, Item 1 of this Quarterly Report on Form 10-Q, pursuant to an Asset Purchase Agreement with Blueprint, in addition to unpaid purchase price consideration, Blueprint is entitled to potential commercial and regulatory milestone payments, as well as tiered royalty payments.
Current wording
Additionally, as discussed in detail in “Note 5 – In-licensing and Acquisition” of our “Notes to Condensed Financial Statements” contained in Part I, Item 1 of this Quarterly Report on Form 10-Q, pursuant to an Asset Purchase Agreement with Blueprint, Blueprint is entitled to potential commercial and regulatory milestone payments, as well as tiered royalty payments.
Previous wording
As discussed above, in connection with the termination of our Credit Agreement with MidCap and entry into the new Credit Agreement, we repaid all outstanding amounts under the term loan facility on May 5, 2026, which was scheduled to mature on September 1, 2027 and had an outstanding principal balance of $45.0 million as of March 31, 2026; such repayment included all outstanding principal, together with applicable prepayment premiums, accrued interest and final payment fees. The revolving credit facility under the new Credit Agreement has a five-year term and bears interest at a rate equal to one-month SOFR, subject to a 2.00% floor, plus an applicable margin of 4.00%. The obligations under the revolving facility is secured by substantially all of our assets, including our intellectual property.
Current wording
As discussed above, we have the revolving credit facility with MidCap under our new Credit Agreement. The revolving credit facility has a five-year term and bears interest at a rate equal to one-month SOFR, subject to a 2.00% floor, plus an applicable margin of 4.00%. The obligations under the revolving credit facility are secured by a first-priority security interest in substantially all of our assets, including our intellectual property. The new Credit Agreement also requires us to pay customary fees, including an unused commitment fee, administrative fees and, during an initial period, prepayment premiums. Accordingly, our material cash requirements include interest payments on any outstanding borrowings under the revolving credit facility, as well as related fees and potential prepayment premiums, which may vary based on utilization levels and prevailing interest rates.
Previous wording
As of March 31, 2026, we have a contractual commitment related to our leased facility, which lease will expire in July 2027. As of March 31, 2026, our contractual commitment related to the lease agreements was $0.9 million, of which $0.7 million is payable in the next 12 months.
Current wording
At June 30, 2026, we have a contractual commitment related to our leased facility, which lease will expire in July 2027. Our remaining lease commitment was approximately $0.8 million, of which $0.7 million is due within the next 12 months.