Niktimvo™ (axatilimab-csfr). The Company and Incyte share equally the profits and losses from co-commercialization efforts in the United States.
The Company and Incyte have agreed to continue to co-develop axatilimab and to share development costs associated with global and additional U.S.-specific clinical trials, with Incyte responsible for 55% of such costs and the Company responsible for 45% of such costs. Each company will be responsible for funding any of its own independent development activities. Incyte is responsible for 100% of future development costs for trials that are specific to ex-U.S. countries. All development costs related to the collaboration will be subject to a joint development plan.
Under the terms of the Incyte Agreements, in December 2021, Incyte paid the Company a non-refundable cash payment of $117.0 million and the Company issued 1,421,523 shares of common stock with an aggregate purchase price of $35.0 million, or $24.62 per share. Additionally, under the terms of the Incyte Agreements, the Company is eligible to receive up to $220.0 million in future contingent development and regulatory milestones and up to $230.0 million in commercialization milestones as well as tiered royalties ranging in the mid-teens percentage on net sales of the licensed product comprising axatilimab in Europe and Japan and low double digit percentage in the rest of the world outside of the United States. The Company’s right to receive royalties in any particular country will expire upon the last to occur of (a) the expiration of licensed patent rights covering the licensed product in that particular country, (b) a specified period of time after the first post-marketing authorization sale of a licensed product in that country, and (c) the expiration of any regulatory exclusivity for that licensed product in that country.
In August 2024, the FDA approved Niktimvo for the treatment of cGVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs). As a result of the approval of Niktimvo, the Company earned a revenue milestone of $12.5 million, which was received in the third quarter of 2024. Upon the achievement of $150.0 million in net sales of Niktimvo, the Company recognized a $5.0 million milestone receivable in the fourth quarter of 2025, which was received in the first quarter of 2026.
For the three and six months ended June 30, 2026, the Company has recognized collaboration revenue of $18.1 million and $34.0 million, respectively. For the three and six months ended June 30, 2025, the Company recognized $9.4 million and $9.1 million of collaboration revenue, respectively. As of June 30, 2026, the Company has recorded approximately $26.4 million as a collaboration receivable due from Incyte related to the Company's portion of the profit share, commercialization and development costs under the Incyte Agreements and has recorded approximately $4.0 million as a collaboration payable due to Incyte for development and commercialization costs incurred by Incyte. As of December 31, 2025, the Company has recorded $28.1 million as a collaboration receivable due from Incyte related to the Company's portion of the profit share, commercialization and development costs under the Incyte Agreements and has recorded approximately $4.4 million as a collaboration payable due to Incyte for development and commercialization costs incurred by Incyte.
The Company’s share of collaboration profit or loss is based on net sales of Niktimvo and the collaborative commercialization expenses.
Vitae Pharmaceuticals, Inc.
In October 2017, the Company entered into a license agreement, or the Vitae License Agreement, with Vitae Pharmaceuticals, Inc., or Vitae, a subsidiary of AbbVie, Inc., or AbbVie, under which the Company was granted an exclusive, sublicensable, worldwide license to a portfolio of preclinical, orally available, small molecule inhibitors of the Menin–KMT2A binding interaction, or the Menin Assets. Upon execution of the Vitae License Agreement, the Company agreed to pay Allergan (the predecessor in interest to AbbVie) up to $99.0 million in one-time development and regulatory milestone payments over the term of the Vitae License Agreement, subject to the achievement of certain milestone events. In the event that the Company or any of its affiliates or sublicensees commercializes the Menin Assets, the Company will also be obligated to pay Vitae low single to low double-digit percentage royalties on sales, subject to reduction in certain circumstances, as well as up to an aggregate of $70.0 million in potential one-time, sales-based milestone payments based on achievement of certain annual sales thresholds. The Company is solely responsible for the development and commercialization of the Menin Assets. Each party may terminate the Vitae License Agreement for the other party’s uncured material breach or insolvency, and the Company may terminate the Vitae License Agreement at any time upon advance written notice to Vitae. Vitae may terminate the Vitae License Agreement if the Company or any of its affiliates or sublicensees institutes a legal challenge to the validity, enforceability, or patentability of the licensed patent rights. Unless terminated earlier in accordance with its terms, the Vitae License Agreement will continue on a country-by-country and product-by-product basis until the later of: (i) the expiration of all of the licensed patent rights in such country; (ii) the expiration of all regulatory exclusivity applicable to the product in such country; and (iii) 10 years from the date of the first commercial sale of the product in such country.
Property and equipment, net, consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2026 |
|
|
2025 |
|
Equipment |
|
$ |
311 |
|
|
$ |
271 |
|
Leasehold improvements |
|
|
167 |
|
|
|
167 |
|
Furniture and fixtures |
|
|
134 |
|
|
|
134 |
|
Office and computer equipment |
|
|
34 |
|
|
|
34 |
|
Total property and equipment |
|
|
646 |
|
|
|
606 |
|
Accumulated depreciation |
|
|
(434 |
) |
|
|
(425 |
) |
Property and equipment, net |
|
$ |
212 |
|
|
$ |
181 |
|
Depreciation expense was $5,000 and $9,000 for the three and six months ended June 30, 2026. There was no depreciation expense for the three and six months ended June 30, 2025.
11. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2026 |
|
|
December 31, 2025 |
|
Product revenue allowances |
|
$ |
11,115 |
|
|
$ |
9,810 |
|
Accrued clinical study and trial costs |
|
|
20,878 |
|
|
|
18,977 |
|
Accrued selling, general, and administrative costs |
|
|
6,483 |
|
|
|
6,316 |
|
Accrued compensation and related costs |
|
|
11,384 |
|
|
|
24,352 |
|
Accrued milestone costs |
|
|
— |
|
|
|
10,000 |
|
Accrued royalty payable |
|
|
8,183 |
|
|
|
7,372 |
|
Accrued interest - royalty interest financing |
|
|
34,149 |
|
|
|
25,516 |
|
Accrued interest - convertible note |
|
|
555 |
|
|
|
— |
|
Other |
|
|
1,550 |
|
|
|
721 |
|
Total accrued expenses and other current liabilities |
|
$ |
94,297 |
|
|
$ |
103,064 |
|
12. Royalty Interest Financing Liability
On November 4, 2024, the Company entered into a Purchase and Sale Agreement, or the Purchase and Sale Agreement, with Royalty Pharma Development Funding, LLC, or Royalty Pharma, pursuant to which Royalty Pharma purchased rights to certain revenue streams from net sales of products comprising or containing axatilimab (including Niktimvo™) by the Company, its affiliates and its licensees in the United States and its respective territories, districts, commonwealths and possessions (including Guam and Puerto Rico) in exchange for an upfront fee of $350 million.
Pursuant to the Purchase and Sale Agreement, Royalty Pharma purchased the right to receive a percentage of net sales equal to a royalty rate of 13.8% on quarterly net sales of Niktimvo in the United States and its respective territories; provided that the royalty rate is subject to certain adjustments based on future aggregate net sales of the product in the United States and its respective territories, or the Revenue Participation Right. Aggregate payments made to Royalty Pharma in respect of the Revenue Participation Right will be capped at $822.5 million, or the Royalty Cap.
The Purchase and Sale Agreement contains customary representations, warranties and indemnities of the Company and Royalty Pharma and customary covenants relating to the royalty payments, including the grant of a back-up security interest in the purchased royalties and certain assets related to the product and restrictions on the incurrence of additional indebtedness and on the existence of liens on the Company’s assets related to the product.
Upon a change of control, the Company will have the right, but not the obligation, to repurchase the Revenue Participation Right at a repurchase price set forth in the Purchase and Sale Agreement. In addition, the Purchase and Sale Agreement provides that if certain events of default occur, including certain bankruptcy events or certain termination events with respect to the Company’s license agreement with UCB Biopharma Srl, Royalty Pharma may require the Company to repurchase Royalty Pharma’s interests in the Revenue Participation Right at a repurchase price equal to the Royalty Cap.
The Company assessed the Purchase and Sale Agreement and identified it as a sale of future revenue in the form of a debt instrument to be accounted for as a liability under Topic ASC 470, Borrower’s Accounting for Debt Modifications. The Company has elected to use the prospective method in its calculation of its effective interest rate and will update this calculation quarterly when there are changes in the projected sales. Issuance costs pursuant to the Purchase and Sale Agreement consisted primarily of bank and
legal fees and totaled $6.3 million. These issuance costs were recorded as a direct deduction to the carrying amount of the liability and will be amortized under the effective interest method over the estimated period the liability will be repaid. For the period ended June 30, 2026, the Company estimated an effective annual interest rate of approximately 13.02%. Over the course of the Purchase and Sale Agreement, the annual interest rate will be affected by the amount and timing of net Niktimvo revenue recognized and change in timing of forecasted net Niktimvo revenue. On a quarterly basis, the Company reassesses the expected timing of the net Niktimvo revenue, recalculates the amortization and effective interest rate, and adjusts the accounting prospectively, as needed. For the three and six months ended June 30, 2026, the Company recognized royalty interest expense of $12.1 million and $24.0 million, respectively. The Company made $15.3 million of payments pursuant to the Purchase and Sale Agreement during the six month period ended June 30, 2026.
|
|
|
|
|
|
|
|
|
|
|
June 30, 2026 |
|
|
December 31, 2025 |
|
Current portion of royalty interest financing liability |
|
$ |
— |
|
|
$ |
— |
|
Royalty interest financing liability, less current portion |
|
|
350,000 |
|
|
|
350,000 |
|
Debt issuance costs |
|
|
(5,974 |
) |
|
|
(6,091 |
) |
Total royalty interest financing liability, net |
|
$ |
344,026 |
|
|
$ |
343,909 |
|
13. Convertible Notes
In June 2026, the Company issued $250.0 million aggregate principal amount of 2.25% Convertible Senior Notes due 2031, or the 2031 Notes, in a private placement to institutional accredited investors that are qualified institutional buyers under Rule 144A in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act. The 2031 Notes are senior, unsecured obligations of the Company and bear interest at 2.25% per annum, payable semi-annually in arrears on June 15 and December 15, beginning December 15, 2026. The 2031 Notes mature on June 15, 2031, unless earlier converted, redeemed, or repurchased. The initial conversion rate is 40.3894 shares of common stock per $1,000 principal amount (equivalent to an initial conversion price of approximately $24.76 per share), subject to customary anti-dilution adjustments under certain circumstances in accordance with the terms of the indenture relating to the 2031 Notes. Upon conversion, the Company will pay or deliver, at its election, cash, shares of its common stock, or a combination of cash and shares of common stock. Before March 15, 2031, the 2031 Notes are convertible only upon the satisfaction of specified conditions; thereafter, the 2031 Notes are convertible at any time until the second scheduled trading day before maturity. The Company may redeem for cash all or any portion of the 2031 Notes (subject to certain limitations) on or after June 20, 2029 if the last reported sale price of its common stock exceeds 130% of the conversion price for a specified period at a redemption price equal to 100% of the principal amount of the 2031 Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. If the Company undergoes a fundamental change (as defined in the indenture governing the 2031 Notes), holders may require the Company to repurchase their 2031 Notes for cash at a price equal to 100% of the principal amount plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. Initially, a maximum of 13,631,400 shares of common stock may be issued upon conversion of the 2031 Notes based on the initial maximum conversion rate of 54.5256 shares of common stock per $1,000 principal amount of 2031 Notes, which is subject to customary anti-dilution adjustment provisions. The 2031 Notes are classified as a long-term liability under ASC 470 and are presented net of unamortized debt issuance costs, which are amortized to interest expense over the term of the 2031 Notes using the effective interest method. Accrued interest related to the 2031 Notes is recorded under the accrued expenses and other current liabilities line of the balance sheet. As of June 30, 2026, the net carrying amount of the 2031 Notes was $244.1 million, unamortized debt issuance costs were $5.9 million, and the effective interest rate was 2.733%.
|
|
|
|
|
|
|
|
|
Current portion of convertible note liability |
|
|
|
|
Convertible note liability, less current portion |
|
|
|
|
|
|
|
|
|
Total convertible note liability, net |
|
|
|
|
14. Stock-Based Compensation
In January 2026, the number of shares of common stock available for issuance under the Company’s 2015 Omnibus Incentive Plan, or the 2015 Plan, was increased by 3,496,239 shares of common stock due to the automatic annual provision to increase shares of common stock available under the 2015 Plan. In March 2026, the 2015 Plan expired. In June 2026, the 2026 Equity Incentive Plan, or 2026 Plan, was approved. The maximum number of shares of the Company’s common stock that may be issued under the 2026 Plan is 17,134,916 shares, which is the sum of (i) 7,200,000 newly authorized shares, plus (ii) up to 9,934,916 shares of common stock
subject to outstanding stock awards granted under the 2015 Plan that, on or after the 2026 Plan becomes effective, expire or otherwise terminate prior to exercise or settlement.
As of June 30, 2026, there were 424,326 shares of common stock available for issuance under the 2023 Plan and 7,448,808 shares of common stock available for issuance under the 2026 Plan.
The Company recognized stock-based compensation expense related to the issuance of stock option awards and restricted stock units to employees and non-employees and related to the Company’s 2015 Employee Stock Purchase Plan, or ESPP, in the consolidated statements of comprehensive loss as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
4,510 |
|
|
$ |
4,196 |
|
|
$ |
8,537 |
|
|
$ |
7,864 |
|
Selling, general and administrative |
|
9,504 |
|
|
|
9,591 |
|
|
|
17,530 |
|
|
|
16,303 |
|
Total |
$ |
14,014 |
|
|
$ |
13,787 |
|
|
$ |
26,067 |
|
|
$ |
24,167 |
|
Compensation expense by type of award in the three and six months ended June 30, 2026 and 2025 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
$ |
8,178 |
|
|
$ |
8,707 |
|
|
$ |
15,739 |
|
|
$ |
16,392 |
|
RSUs |
|
5,624 |
|
|
|
4,757 |
|
|
|
9,905 |
|
|
|
7,332 |
|
ESPP |
|
212 |
|
|
|
323 |
|
|
|
423 |
|
|
|
443 |
|
Total |
$ |
14,014 |
|
|
$ |
13,787 |
|
|
$ |
26,067 |
|
|
$ |
24,167 |
|
In addition, stock-based compensation expense of $0.1 million and $0.2 million was capitalized to inventory for the three and six months ended June 30, 2026, respectively, which represents the stock-based compensation expense incurred related to employees involved in the manufacturing process of finished goods and samples. For the three and six months ended June 30, 2025, $0.1 million and $0.2 million of stock compensation expense was capitalized to inventory.
As of June 30, 2026, there were $103.4 million of unrecognized compensation costs related to employee and non-employee unvested stock options and RSUs granted under the Inducement Plan, 2015 Plan, 2026 Plan, and the Company’s 2007 Stock Plan, which are expected to be recognized over a weighted-average remaining service period of 2.67 years.
Employee Benefit Plan
The Company maintains a defined contribution 401(k) retirement plan. For the three and six months ended June 30, 2026, the Company made $0.3 million and $2.8 million, respectively, of contributions to the plan. For the three and six months ended June 30, 2025, the Company made $0.3 million and $2.6 million, respectively, of contributions to the plan. The Company’s contributions were made in cash.
15. Stockholders’ Equity
Pre-Funded Warrants
In December 2021, the Company sold pre-funded warrants to purchase 1,142,856 shares of common stock. As of June 30, 2026, 285,714 pre-funded warrants were issued and outstanding.
16. Commitments and Contingencies
License Agreements
The Company is obligated to pay royalties pursuant to the Vitae License Agreement and the UCB License Agreement as a percentage of net product sales for direct licensed products, such as Revuforj and Niktimvo. The obligation to pay royalties expires, on a country-by-country basis and licensed product-by-licensed product basis at the later of (i) the expiration of all of the licensed patent
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following information should be read in conjunction with the unaudited financial information and the notes thereto included in this Quarterly Report on Form 10-Q, or the Quarterly Report, and the audited financial information and the notes thereto included in our Annual Report on Form 10-K that was filed with the Securities and Exchange Commission, or SEC, on February 26, 2026.
Company Overview
We are a commercial-stage biopharmaceutical company advancing innovative cancer therapies. We currently have two commercially approved medicines, Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr), and a robust pipeline of late- and early-stage development programs.
Revuforj is our first-in-class menin inhibitor that was approved by the U.S. Food and Drug Administration, or FDA, in November 2024 for the treatment of relapsed or refractory, or R/R, acute leukemia with a lysine methyltransferase 2A gene, or KMT2A, translocation in adult and pediatric patients one year and older. In October 2025, Revuforj received a second approval from the FDA for the treatment of R/R acute myeloid leukemia, or AML, with a susceptible nucleophosmin 1 mutation, or NPM1m, in adult and pediatric patients one year and older who have no satisfactory alternative treatment options. We are also studying revumenib in combination with standard-of-care agents in NPM1m AML or KMT2A-rearranged, or KMT2Ar, acute leukemia across the treatment landscape, including in newly diagnosed patients.
Niktimvo is our first-in-class colony stimulating factor-1 receptor, or CSF-1R, blocking antibody that was approved by the FDA in August 2024 for the treatment of chronic graft-versus-host disease, or cGVHD, after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. Axatilimab is in development for the treatment of newly diagnosed cGVHD patients in combination with standard-of-care therapies, and for the treatment of idiopathic pulmonary fibrosis, or IPF.
We licensed the global rights to revumenib and axatilimab, the first two FDA approved medicines to emerge from our pipeline. We are leading the commercialization and further development of revumenib and working closely with our collaboration partner, Incyte, on the commercialization and further development of axatilimab. We plan to continue to leverage the technical and business expertise of our management team and scientific collaborators to license, acquire and develop additional therapeutics to expand our pipeline.
In July 2026, we announced two new pipeline assets, SNDX-4321 and SNDX-62122. SNDX-4321 is a novel, mutant-selective, allosteric epidermal growth factor receptor, or EGFR, inhibitor designed to address non-small cell lung cancer, or NSCLC, patient populations with significant unmet needs. The Company has an exclusive worldwide license to develop and commercialize SNDX-4321. SNDX-62122 is a next-generation menin inhibitor in development for myelofibrosis, or MF. SNDX-62122 is the first molecule from our library of internally developed and wholly owned next-generation menin inhibitors that we intend to advance into new areas. Our SNDX-62122 program builds off recently published revumenib preclinical data showing that menin is a novel dependency in proliferative megakaryocytes, major drivers of MF. We expect the development of SNDX-62122 to be informed and de-risked by a planned Phase 1/2 proof-of-principle trial of revumenib in MF.
We have incurred significant operating losses since our inception. While we generate product revenue from sales of Revuforj and collaboration as well as milestone revenue from sales of Niktimvo, we continue to incur significant research and development and other expenses related to our ongoing operations. Except for 2021, we have not been profitable and have incurred losses in each period since our inception in 2005. For the six months ended June 30, 2026 and 2025, we reported a net loss of $92.0 million and $156.7 million, respectively. As of June 30, 2026, we had an accumulated deficit of $1.6 billion. As of June 30, 2026, we had cash, cash equivalents and short- and long-term investments of $575.1 million.
Recent Business Highlights
Revuforj®(revumenib)
•Achieved $54.7 million in Revuforj net revenue in the second quarter of 2026, a 91% increase over the second quarter of 2025 and a 12% increase over the first quarter of 2026. Total prescriptions were approximately 1,500 in the second quarter of 2026, an approximate 121% increase over the second quarter of 2025 and a 15% increase over the first quarter of 2026. The net revenue and prescription growth reflects an increasing average treatment duration, primarily driven by a growing pool of patients receiving Revuforj for an extended period in the post-transplant setting.
•Advanced our scientific leadership in menin inhibition with the presentation of 16 revumenib abstracts at the 2026 American Society of Clinical Oncology, or ASCO, and the European Hematology Association, or EHA, annual meetings in June 2026. The data presented span multiple acute leukemia subtypes and settings, including frontline and post-transplant maintenance.
•Published data from the Phase 1/2 SAVE trial of an all-oral combination of revumenib, decitabine/cedazuridine, and venetoclax in R/R NPM1m, KMT2Ar, and NUP98r AML in the Journal of Clinical Oncology in June 2026. The results showed deep and durable remissions in a heavily pretreated patient population. The overall response rate was 88% (37/42), composite complete remission, or CRc, rate was 71% (30/42), and complete remission plus complete remission with partial hematologic recovery rate was 60% (25/42). 80% of evaluable CRc responders were measurable residual disease, or MRD, negative. 45% (19/42) of patients proceeded to a transplant and 63% (12/19) resumed revumenib post-transplant.
•Published preclinical revumenib data showing that menin is a novel dependency in proliferative megakaryocytes, major drivers of MF, in Cancer Cell in July 2026. These data provide the basis for our plans to develop SNDX-62122, an internally developed, next-generation menin inhibitor, for MF.
•We expect to have a major presence at upcoming medical meetings in the second half of 2026 with the presentation of new/updated revumenib data including:
•Real-world evidence from multiple centers
•Post-transplant maintenance data
•Frontline data from the BEAT AML trial of revumenib in combination with venetoclax/azacitidine in NPM1m and KMT2Ar AML.
•Frontline data from the Phase 1/2 SAVE trial of an all-oral combination of revumenib, decitabine/cedazuridine, and venetoclax in NPM1m, KMT2Ar, or NUP98r AML.
•Frontline data from the Phase 1 trial of revumenib in combination with intensive chemotherapy in NPM1m, KMT2Ar, or NUP98r AML.
•Multiple clinical trials evaluating revumenib across the acute leukemia treatment continuum are ongoing, such as:
•EVOLVE-2: A pivotal, Phase 3, randomized, double-blind, placebo-controlled trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed NPM1m (primary efficacy analysis population) and KMT2Ar AML patients who are unfit for intensive chemotherapy. The trial is being conducted in collaboration with the HOVON network, a leading cooperative clinical trial group with extensive experience studying novel therapies for hematologic malignancies.
•REVEAL-ND: A pivotal, Phase 3, randomized, double-blind, placebo-controlled trial of revumenib in combination with intensive chemotherapy in newly diagnosed NPM1m AML patients.
•SAVE: A Phase 1/2 trial evaluating an all-oral combination of revumenib with venetoclax and decitabine/cedazuridine in pediatric and adult patients with newly diagnosed and R/R AML or mixed-lineage acute leukemia harboring either NPM1m, KMT2Ar, or NUP98r alterations. The trial is being conducted by investigators from MD Anderson Cancer Center.
•Intensive chemotherapy: Two ongoing Phase 1 trials evaluating the combination of revumenib with intensive chemotherapy (7+3) in newly diagnosed NPM1m or KMT2Ar acute leukemia patients.
•BEAT AML: A Phase 1 trial evaluating the combination of revumenib with venetoclax and azacitidine in newly diagnosed older adults (≥60 years) with NPM1m or KMT2Ar AML. The trial is being conducted as part of the Leukemia & Lymphoma Society's Beat AML® Master Clinical Trial.
•Post-transplant maintenance: A Phase 1 trial evaluating the safety and preliminary efficacy of revumenib as post-transplant maintenance in patients with KMT2Ar or NPM1m acute leukemia. The trial is being conducted by investigators from the City of Hope Medical Center.
•Break Through Cancer: A Phase 2 trial studying whether the combination of revumenib and venetoclax can eliminate MRD in patients with AML and extend progression-free survival. The trial is being conducted by Break Through Cancer, a collaboration between leading U.S. cancer research centers.
•INTERCEPT: A Phase 1 trial evaluating the use of novel therapies, including revumenib, to target MRD and early relapse in AML. The trial is being conducted by the Australasian Leukaemia and Lymphoma Group as part of the INTERCEPT AML master clinical trial.
•We expect the RAVEN trial to initiate in the second half of 2026. RAVEN is a Phase 2 collaborative trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed KMT2Ar patients who would be considered eligible, or fit, for intensive chemotherapy.
•We expect the MenTain Phase 2 trial to initiate around the end of 2026. MenTain will be the first randomized, placebo-controlled trial specifically focused on evaluating revumenib as post-transplant maintenance.
•We expect to publish safety and efficacy data from R/R NUP98r acute leukemia patients treated with revumenib in the fourth quarter of 2026.
Niktimvo™ (axatilimab-csfr)
•Achieved $60.3 million in Niktimvo net revenue in the second quarter of 2026, a 67% increase over the second quarter of 2025 and a 9% increase over the first quarter of 2026. Syndax and Incyte are co-commercializing Niktimvo. Syndax records 50% of the Niktimvo net commercial profit, defined as net product revenue minus the cost of sales and commercial expenses. Syndax’s share of the Niktimvo product contribution, reported as collaboration revenue, was $18.1 million in the second quarter of 2026.
•Two trials evaluating axatilimab in combination with standard of care therapies in newly diagnosed chronic GVHD patients are ongoing, including:
•A Phase 2, open-label, randomized, multicenter trial of axatilimab in combination with ruxolitinib in patients ≥ 12 years of age with newly diagnosed chronic GVHD. We anticipate topline data in the fourth quarter of 2026.
•A pivotal Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of axatilimab in combination with corticosteroids in patients ≥ 12 years of age with newly diagnosed chronic GVHD. We anticipate topline data in early 2028.
•We anticipate topline data from MAXPIRe, a Phase 2, 26-week randomized, double-blinded, placebo-controlled trial of axatilimab on top of standard of care in patients with IPF in the fourth quarter of 2026.
Pipeline Assets
SNDX-4321
•In July 2026, we announced the expansion of our pipeline with SNDX-4321, a mutant-selective, CNS-penetrant, allosteric EGFR inhibitor. SNDX-4321 is in development for NSCLC patient populations with significant unmet needs, such as those with L858R mutations, CNS metastases, atypical activating mutations, or acquired resistance to current therapies. In contrast to ATP-site directed third and fourth generation EGFR inhibitors, SNDX-4321 is a novel allosteric inhibitor which binds at a pocket adjacent to the ATP site that is only accessible in the presence of L858R and certain other EGFR mutations.
•We expect to submit an investigational new drug (IND) application for SNDX-4321 by the end of 2026 and to initiate a Phase 1 trial in EGFRm NSCLC in 2027.
SNDX-62122
•In July 2026, we announced the selection of SNDX-62122, a next-generation menin inhibitor, for development in MF. SNDX-62122 is the first candidate from a library of internally developed, wholly owned next-generation menin inhibitors that we intend to advance into new areas.
•We expect to submit an IND and initiate a Phase 1 trial of SNDX-62122 in MF in 2027. The development of SNDX-62122 will be informed by a Phase 1/2 proof-of-principle trial of revumenib in MF that is expected to initiate in the fourth quarter of 2026 with initial clinical data expected in the second half of 2027.
Financial Operations Overview
Product Revenue, net
Our FDA-approved product, Revuforj, was approved by the FDA for commercial sale in the U.S. on November 15, 2024. In accordance with GAAP, we determine net product revenue for Revuforj, with specific assumptions for variable consideration components including, but not limited to, trade discounts and allowances, co-pay assistance programs and payor rebates. We record product revenue net of estimated discounts, chargebacks, rebates, product returns, and other gross-to-net revenue deductions.
Collaboration revenue, net
In September 2021, we entered into the Incyte License and Collaboration Agreement, or the Incyte License, with Incyte covering the worldwide development and commercialization of axatilimab. In August 2024, the FDA approved Niktimvo for the treatment of cGVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).
In accordance with Topic ASC 808, Collaboration Arrangements, Incyte has been identified as the principal in product sales, therefore, we will recognize its 50% share of any profits or losses in the amount of net product sales less cost of goods sold and shared commercial and other expenses, in the period in which the underlying sales and costs are recognized. Our share of net profits in connection with commercialization of Niktimvo will be presented as “Collaboration revenue, net” and our share of net losses will be presented as “Collaboration loss, net” within operating expenses. Collaboration revenue or expense is made up of our share of the 50% profit with Incyte. We record collaboration revenue net of commercial expenses, including any royalties owed on license agreements. We will continue to recognize the costs associated with ongoing development services in the R&D operating expense line, including any cost-sharing components with Incyte.
Cost of Product Sales
Our cost of product sales includes the cost of goods sold for Revuforj and license agreement royalties associated with its sales in the United States. Until we received regulatory approval for Revuforj in the United States in November 2024, we recorded expenses incurred for the manufacturing of pre-launch inventory that would support a U.S. launch as research and development expense. Accordingly, the cost of goods sold for a Revuforj may not include the full cost of manufacturing until the initial pre-launch, and previously expensed, inventory is depleted.
Research and Development
Since our inception, we have primarily focused on our clinical development programs. Research and development expenses consist primarily of costs incurred for the development of our products and product candidates and include:
•expenses incurred under agreements related to our clinical trials, including the costs for investigative sites and contract research organizations, or CROs, that conduct our clinical trials;
•employee-related expenses associated with our research and development activities, including salaries, benefits, travel and non-cash stock-based compensation expenses;
•manufacturing process-development, clinical supplies and technology-transfer expenses;
•license fees and milestone payments under our license agreements;
•consulting fees paid to third parties;
•allocated facilities and overhead expenses; and
•costs associated with regulatory operations and regulatory compliance requirements.
Internal and external research and development costs are expensed as they are incurred. Cost-sharing amounts received by us are recorded as reductions to research and development expense. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or other information provided to us by our vendors.
Research and development activities are central to our business model. Product candidates in late stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of late-stage clinical trials. We plan to continue to spend a significant amount of our resources on research and development activities for the foreseeable future as we continue to advance the development of our products and product candidates. The amount of research and development expenses allocated to external spending will continue to grow, while we expect our internal spending to grow at a slower and more controlled pace.
It is difficult to determine, with certainty, the duration and completion costs of our current or future preclinical programs, research studies and clinical trials of our product candidates. The duration, costs and timing of research studies and clinical trials of our products and product candidates will depend on a variety of factors that include, but are not limited to, the following:
•the number of patients that participate;
•the number of clinical trial sites;
•the countries in which the trials are conducted;
•the length of time required to enroll eligible patients;
•the potential additional safety monitoring or other studies requested by regulatory agencies;
•the duration of patient monitoring;
•the efficacy and safety profile of the product candidates; and
•timing and receipt of any regulatory approvals.
In addition, the probability of success for each product candidate will depend on numerous factors, including competition, manufacturing capability and commercial viability. The successful development of our products and additional product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs of the efforts that will be necessary to complete the remainder of the development of our products and additional product candidates for the period, if any, in which material net cash inflows from these potential product candidates may commence. Clinical development timelines, the probability of success and development costs can differ materially from expectations.
Selling, General and Administrative
Selling, general and administrative expenses consist primarily of employee-related expenses, including salaries, benefits, non-cash stock-based compensation and travel expenses, for our employees in executive, finance, human resources, business development and support functions, as well as sales and marketing expenses to support the launch and commercialization of Revuforj and Niktimvo. Other selling, general and administrative expenses include facility-related costs not otherwise allocated to research and development expenses and accounting, tax, legal, information technology and consulting services.
Royalty Interest Expense
Royalty interest expense consists of the interest recorded related to the Royalty Pharma Purchase and Sale Agreement under the effective interest method.
Convertible Note Interest Expense
Convertible note interest expense consists of the interest recorded related to the convertible note liability under the effective interest method.
Interest Expense
Interest expense consists primarily of expense related to the interest recognized for capital leases.
Interest Income
Interest income consists of income earned on our cash, cash equivalents and short- and long-term investment balances.
Other (Expense) Income, net
Other (expense) income, net consists of the revaluation of foreign currency related to trade payables.
Recent Accounting Pronouncements
For a discussion of new accounting pronouncements please read Note 3 - Summary of Significant Accounting Policies to our unaudited consolidated financial statements included in this Quarterly Report.
Critical Accounting Policies and Estimates
Our management’s discussion and analysis of financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP. The preparation of these financial statements requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenue and expenses and related disclosures of contingent assets and liabilities. We base our estimates on historical experience, known trends and events and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. In making estimates and judgments, management employs critical accounting policies.
There have been no material changes to our critical accounting estimates described in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025.
Results of Operations
Comparison of the three and six months ended June 30, 2026 and 2025:
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Three Months Ended June 30, |
|
|
Change |
|
|
Six Months Ended June 30, |
|
|
Change |
|
|
|
2026 |
|
|
2025 |
|
|
$ |
|
|
2026 |
|
|
2025 |
|
|
$ |
|
|
|
(In thousands) |
|
|
(In thousands) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
|
$ |
54,700 |
|
|
$ |
28,600 |
|
|
$ |
26,100 |
|
|
$ |
103,623 |
|
|
$ |
48,642 |
|
|
|
54,981 |
|
Collaboration revenue, net |
|
|
18,088 |
|
|
|
9,358 |
|
|
|
8,730 |
|
|
|
34,029 |
|
|
|
9,111 |
|
|
|
24,918 |
|
Total revenues |
|
|
72,788 |
|
|
|
37,958 |
|
|
|
34,830 |
|
|
|
137,652 |
|
|
|
57,753 |
|
|
|
79,899 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
$ |
3,208 |
|
|
$ |
1,279 |
|
|
$ |
1,929 |
|
|
$ |
5,841 |
|
|
$ |
2,164 |
|
|
|
3,677 |
|
Research and development |
|
|
68,036 |
|
|
|
62,227 |
|
|
|
5,809 |
|
|
|
126,881 |
|
|
|
123,863 |
|
|
|
3,018 |
|
Selling, general and administrative |
|
|
41,539 |
|
|
|
43,805 |
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|
|
(2,266 |
) |
|
|
79,127 |
|
|
|
84,836 |
|
|
|
(5,709 |
) |
Total operating expenses |
|
|
112,783 |
|
|
|
107,311 |
|
|
|
5,472 |
|
|
|
211,849 |
|
|
|
210,863 |
|
|
|
986 |
|
Loss from operations |
|
|
(39,995 |
) |
|
|
(69,353 |
) |
|
|
(29,358 |
) |
|
|
(74,197 |
) |
|
|
(153,110 |
) |
|
|
(78,913 |
) |
Other (expense) income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty interest expense |
|
|
(12,119 |
) |
|
|
(7,854 |
) |
|
|
(4,265 |
) |
|
|
(23,965 |
) |
|
|
(15,903 |
) |
|
|
(8,062 |
) |
Convertible note interest expense |
|
|
(555 |
) |
|
|
— |
|
|
|
(555 |
) |
|
|
(555 |
) |
|
|
— |
|
|
|
(555 |
) |
Other interest expense |
|
|
(2 |
) |
|
|
(4 |
) |
|
|
2 |
|
|
|
(2 |
) |
|
|
(6 |
) |
|
|
4 |
|
Interest income |
|
|
3,746 |
|
|
|
5,950 |
|
|
|
(2,204 |
) |
|
|
7,307 |
|
|
|
13,133 |
|
|
|
(5,826 |
) |
Other expense |
|
|
(438 |
) |
|
|
(586 |
) |
|
|
148 |
|
|
|
(624 |
) |
|
|
(807 |
) |
|
|
183 |
|
Total other (expense) income, net |
|
|
(9,368 |
) |
|
|
(2,494 |
) |
|
|
(6,874 |
) |
|
|
(17,839 |
) |
|
|
(3,583 |
) |
|
|
(14,256 |
) |
Net loss |
|
$ |
(49,363 |
) |
|
$ |
(71,847 |
) |
|
$ |
(22,484 |
) |
|
$ |
(92,036 |
) |
|
$ |
(156,693 |
) |
|
$ |
(64,657 |
) |
Product Revenue, net
In November 2024, we began to generate product revenue from sales of Revuforj in the United States. Product revenue, net from sales of Revuforj for the three and six months ended June 30, 2026, was $54.7 million and $103.6 million, respectively. The increase in product revenue from the comparable prior period end was due to increased sales volume as a result of increased brand awareness.
Collaboration Revenue, net
Collaboration revenue, net, representing our share of net profits in connection with commercialization of Niktimvo, for the three and six months ended June 30, 2026, was $18.1 million and $34.0 million, respectively. The increase in collaboration revenue from the comparable prior period end was due to increased sales volume as a result of increased brand awareness.
Cost of Product Sales
Our cost of product sales increased by $1.9 million from the comparable prior year period due to increased product sales of Revuforj. Included in cost of product sales are royalties owed to AbbVie on Revuforj sales as part of the Vitae License Agreement.
Research and Development
The following table summarizes the research and development expenses for the three and six months ended June 30, 2026 and 2025:
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Three Months Ended June 30, |
|
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Change |
|
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Six Months Ended June 30, |
|
|
Change |
|
|
|
2026 |
|
|
2025 |
|
|
$ |
|
|
2026 |
|
|
2025 |
|
|
$ |
|
|
|
(In thousands) |
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|
(In thousands) |
|
Revumenib-related costs |
|
$ |
35,493 |
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|
$ |
28,156 |
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|
$ |
7,337 |
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|
$ |
61,218 |
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|
$ |
48,960 |
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|
$ |
12,258 |
|
Axatilimab-related costs |
|
|
8,682 |
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|
|
9,053 |
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|
|
(371 |
) |
|
|
18,315 |
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|
|
28,764 |
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|
|
(10,449 |
) |
Other research and development programs |
|
|
1,043 |
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|
|
1,789 |
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|
|
(746 |
) |
|
|
1,205 |
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|
|
2,747 |
|
|
|
(1,542 |
) |
Personnel cost and other expenses |
|
|
18,308 |
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|
|
19,033 |
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|
|
(725 |
) |
|
|
37,606 |
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|
|
35,528 |
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|
|
2,078 |
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Stock-based compensation |
|
|
4,510 |
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|
|
4,196 |
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|
|
314 |
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|
|
8,537 |
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|
|
7,864 |
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|
|
673 |
|
Total research and development expenses |
|
$ |
68,036 |
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|
$ |
62,227 |
|
|
$ |
5,809 |
|
|
$ |
126,881 |
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|
$ |
123,863 |
|
|
$ |
3,018 |
|
For the three and six months ended June 30, 2026, our total research and development expenses increased by $5.8 million and $3.0 million from the comparable prior year periods, respectively. The changes were primarily due to:
•Revumenib: An increase in the three and six months ended June 30, 2026, from the comparable prior year period, due to frontline trials evaluating revumenib in combination with standard-of-care agents in the treatment of AML;
•Axatilimab: A decrease in the three months ended June 30, 2026, from the comparable prior year period due to timing of trials and a decrease in the six months ended June 30, 2026, from the comparable prior year period due to a non-recurring $10.0 million development milestone expense recognized in the first quarter of 2025;
•A decrease in other research and development programs for the three and six months ended June 30, 2026, from the comparable prior year period due to timing of research and development activities;
•A decrease in personnel cost and other expenses for the three months ended June 30, 2026, from the comparable prior year period due to lower headcount and an increase for the six months ended June 30, 2026, from the comparable prior year period due to costs related to the on-going support of clinical trials and medical affairs; and
•An increase in stock-based compensation from the comparable prior year period driven by a higher stock price.
Selling, General and Administrative
The following tables summarizes the selling, general and administrative expenses for the three and six months ended June 30, 2026 and 2025:
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|
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|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Change |
|
|
Six Months Ended June 30, |
|
|
Change |
|
|
|
2026 |
|
|
2025 |
|
|
$ |
|
|
2026 |
|
|
2025 |
|
|
$ |
|
|
|
(In thousands) |
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|
(In thousands) |
|
Commercial related expenses |
|
$ |
9,869 |
|
|
$ |
9,874 |
|
|
$ |
(5 |
) |
|
$ |
17,590 |
|
|
$ |
20,739 |
|
|
$ |
(3,149 |
) |
Other selling, general and administrative expenses |
|
|
5,868 |
|
|
|
5,034 |
|
|
|
834 |
|
|
|
11,008 |
|
|
|
9,405 |
|
|
|
1,603 |
|
Personnel cost and other expenses |
|
|
16,298 |
|
|
|
19,306 |
|
|
|
(3,008 |
) |
|
|
32,999 |
|
|
|
38,389 |
|
|
|
(5,390 |
) |
Stock-based compensation |
|
|
9,504 |
|
|
|
9,591 |
|
|
|
(87 |
) |
|
|
17,530 |
|
|
|
16,303 |
|
|
|
1,227 |
|
Total selling, general and administrative expenses |
|
$ |
41,539 |
|
|
$ |
43,805 |
|
|
$ |
(2,266 |
) |
|
$ |
79,127 |
|
|
$ |
84,836 |
|
|
$ |
(5,709 |
) |
For the three and six months ended June 30, 2026, our total selling, general and administrative expenses decreased by $2.3 million and $5.7 million, respectively, from the comparable prior year periods. The changes were primarily due to;
•A decrease in commercial-related expenses due to launch costs incurred in the first quarter of 2025 for Revuforj and Niktimvo that were not incurred in 2026;
•An increase in other selling, general and administrative expenses from the comparable prior year period to further support corporate growth;
•A decrease in personnel expenses from the comparable prior year period due to a decrease in overall headcount; and
•An increase in stock-based compensation for the six months ended June 30, 2026, from the comparable prior year period driven by a higher stock price.
Royalty Interest Expense
For the three and six months ended June 30, 2026, royalty interest expense increased from the comparable prior year period due to the interest expense recognized related to the Royalty Pharma Purchase and Sale Agreement signed in November 2024.
Convertible Note Interest Expense
For the three and six months ended June 30, 2026, convertible note interest expense increased from the comparable prior year period due to the interest expense recognized as a result of the sale and issuance of the convertible notes in June 2026.
Interest Income
For the three and six months ended June 30, 2026, interest income decreased from the comparable prior year period. The decrease of interest income was primarily due to the fluctuation of interest rates and the average balance of cash equivalents and short and long-term investments.
Other Expense
For the three and six months ended June 30, 2026, the total other expense, net decreased from the comparable prior year period primarily due to the fluctuation in foreign currency losses on short- and long-term investments.
Liquidity and Capital Resources
Cash Flows
The following table sets forth the primary sources and uses of cash and cash equivalents for each period set forth below:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
|
2026 |
|
|
2025 |
|
|
|
(In thousands) |
|
Net cash used in operating activities |
|
$ |
(80,617 |
) |
|
$ |
(182,957 |
) |
Net cash provided by investing activities |
|
|
21,476 |
|
|
|
136,029 |
|
Net cash provided by financing activities |
|
|
260,688 |
|
|
|
1,481 |
|
Net increase (decrease) cash, cash equivalents and restricted cash |
|
$ |
201,547 |
|
|
$ |
(45,447 |
) |
Net Cash Used in Operating Activities
Net cash used in operating activities decreased from $183.0 million for the six months ended June 30, 2025 to $80.6 million for the six months ended June 30, 2026, primarily due to a decrease in operating net loss of $64.7 million, as well as decreases in accounts receivable, inventory, and prepaid expenses; offset by decreases in accounts payable and accrued expenses.
Net Cash Provided by Investing Activities
Net cash provided by investing activities for the six months ended June 30, 2026, was $21.5 million and was related to $146.8 million from the maturities of available-for-sale securities, partially offset by the purchase of $125.3 million of available-for-sale securities.
Net cash provided by investing activities for the six months ended June 30, 2025, was $136.0 million and was related to $238.3 million from the maturities of available-for-sale securities, partially offset by the purchase of $102.3 million of available-for-sale securities.
Net Cash Provided by Financing Activities
Net cash provided by financing activities for the six months ended June 30, 2026, increased by $259.2 million from the comparable prior year period as a result of cash raised from the sale and issuance of convertible notes in June 2026, and proceeds from exercised stock options.
Purchase and Sale Agreement
In October 2024, we entered into a purchase and sale agreement with Royalty Pharma, pursuant to which Royalty Pharma purchased the right to receive 13.8% on quarterly net sales of Niktimvo in the United States and its respective territories, districts, commonwealths and possessions (including Guam and Puerto Rico) in exchange for an upfront payment of $350.0 million (gross) at closing, received in November 2024. Aggregate payments to Royalty Pharma pursuant to the Royalty Agreement will be capped at $822.5 million or 2.35 times the funded amount.
For additional details on our purchase and sale agreement with Royalty Pharma, see Note 12 - “Royalty Interest Financing Liability” to our consolidated financial statements in this Quarterly Report.
Convertible Notes
In June 2026, we issued $250.0 million aggregate principal amount of 2.25% Convertible Senior Notes, or the 2031 Notes, due 2031 in a private placement to institutional accredited investors that were qualified institutional buyers under Rule 144A in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act. The 2031 Notes are senior unsecured obligations of ours and bear interest at 2.25% per annum, payable semi-annually in arrears on June 15 and December 15, beginning December 15, 2026. The 2031 Notes mature on June 15, 2031, unless earlier converted, redeemed, or repurchased. The initial conversion rate is 40.3894 shares of common stock per $1,000 principal amount (equivalent to an initial conversion price of approximately $24.76 per share), subject to customary anti-dilution adjustments under certain circumstances in accordance with the terms of the indenture relating to the 2031 Notes. Upon conversion, we will pay or deliver, at our election, cash, shares of our common stock, or a combination of cash and shares of common stock. Before March 15, 2031, the 2031 Notes are convertible only upon the satisfaction of specified conditions; thereafter, the 2031 Notes are convertible at any time until the second scheduled trading day before maturity. We may redeem for cash all or any portion of the 2031 Notes, in whole or in part, on or after June 20, 2029 if the last reported sale price of our common stock exceeds 130% of the conversion price for a specified period at a redemption price equal to 100% of the principal amount of the 2031 Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. If we undergo a fundamental change (as defined in the indenture governing the 2031 notes), holders may require us to repurchase their 2031 Notes for cash at a price equal to 100% of the principal amount plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. Initially, a maximum of 13,631,400 shares of common stock may be issued upon conversion of the 2031 Notes based on the initial maximum conversion rate of 54.5256 shares of common stock per $1,000 principal amount of 2031 Notes, which is subject to customary anti-dilution adjustment provisions. The 2031 Notes are classified as a long-term liability and are presented net of unamortized debt issuance costs, which are amortized to interest expense over the term of the 2031 Notes using the effective interest method.
Future Funding Requirements
We believe that the combination of our available cash, cash equivalents, short- and long-term investments, as well as our expected product revenues from sales of Revuforj and Niktimvo collaboration revenue, is sufficient to fund existing and planned cash requirements. Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, third-party clinical research and development services, clinical costs, commercialization costs, legal and other regulatory expenses and general overhead costs. We have based our estimates on assumptions that may prove to be incorrect, and we could use our capital resources sooner than we currently expect.
Additionally, the process of testing product candidates in clinical trials is costly, and the timing, progress and outcomes in these trials is uncertain. We cannot estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates or whether, or when, we may achieve profitability.
Our future capital requirements will depend on many factors, including:
•the initiation, progress, timing, costs and results of clinical trials of our product candidates;
•the outcome, timing and cost of seeking and obtaining additional regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more trials than we currently expect;
•our ability to satisfy our obligations under the indenture governing the 2031 Notes;
•the cost to establish, maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing any patents or other intellectual property rights;
•market acceptance of our approved products as well as our product candidates;
•the cost and timing of selecting, auditing and developing manufacturing capabilities, and potentially validating manufacturing sites for commercial-scale manufacturing;
•the cost and timing for obtaining pricing and reimbursement, which may require additional trials to address pharmacoeconomic benefit;
•the cost of maintaining and expanding sales, marketing and distribution capabilities for our products;
•the costs of acquiring, licensing or investing in additional businesses, products, product candidates and technologies;
•the interruption of key clinical trial activities, such as clinical trial site monitoring;
•the cost of disruption to our supply chain and operations, and associated delays in the manufacturing and supply of our products, which would adversely impact our ability to continue our clinical trial operations;
•the effect of competing technological and market developments; and
•our need to implement additional internal systems and infrastructure, including financial and reporting systems, as we grow our company.
We expect to continue to support our future cash needs through a combination of equity offerings, debt financings and additional funding from license and collaboration arrangements. Except for any obligations of our collaborators to reimburse us for research and development expenses or to make milestone or royalty payments under our agreements with them, we will not have any committed external source of liquidity.
With respect to our outstanding convertible notes, cash interest payments are payable on a semi-annual basis in arrears, which will require total funding of $5.7 million annually.
Our material contractual obligations and commitments as of June 30, 2026, primarily relate to our maturities of operating leases for office space and equipment and capital leases for office equipment. As of June 30, 2026, we have $0.5 million payable within 12 months.
Except as disclosed above, we have no material non-cancelable purchase commitments with service providers, as we have generally contracted on a cancelable, purchase-order basis. We enter into contracts in the normal course of business with equipment and reagent vendors, CROs, contract manufacturing organizations, and other third parties for clinical trials, preclinical research studies and testing and manufacturing services. These contracts are cancelable by us upon prior notice. Payments due upon cancellation consist only of payments for services provided or expenses incurred, including noncancelable obligations of our service providers, up to the date of cancellation. These payments are not determinable.
We have incurred losses and cumulative negative cash flows from operations since our inception, excluding the year ended December 31, 2021. As of June 30, 2026, we had an accumulated deficit of $1.6 billion. We anticipate that we will likely continue to incur significant losses for at least the next couple years. To the extent that we raise additional capital through the future sale of equity or debt, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raise additional funds through collaboration arrangements in the future, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
At-the-Market Offering Program
In May 2023, we entered into a sales agreement with Cowen and Company, LLC, or TD Cowen, under which we could, from time to time, issue and sell shares of our common stock having aggregate sales proceeds of up to $200.0 million, in a series of one or more at-the-market equity offerings, or the 2023 ATM Program. TD Cowen is not required to sell any specific share amounts but acts as the Company’s sales agent, using commercially reasonable efforts consistent with its normal trading and sales practices. Pursuant to the sales agreement, shares will be sold under the shelf registration statement on Form S-3ASR (Registration No. 333-277424), which became automatically effective upon filing on February 27, 2024. Our common stock will be sold at prevailing market prices at the time of the sale, and as a result, prices may vary. For the three and six months ended June 30, 2026, we did not sell any shares of common stock under the 2023 ATM Program. As of June 30, 2026, we had $157.9 million available under the 2023 ATM Program.
Significant Risks and Uncertainties
Unfavorable interest rates and geo-political unrest could result in further economic uncertainty and volatility in the capital markets in the near term and, as a result, could negatively affect our operations and could make it difficult for us to obtain traditional financing on acceptable terms, if at all. Furthermore, such economic conditions have produced downward pressure on share prices. Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, the return of a high inflationary environment could increase our operating costs, including our labor costs and research and development costs. These costs may also be negatively impacted due to supply chain constraints, geopolitical tensions, including tariffs, wars and terrorism, worsening macroeconomic conditions and employee availability and wage increases, which may result in additional stress on our working capital.
Additionally, we are subject to other challenges and risks specific to our business and our ability to execute on our strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of additional indications for our approved products; identifying, acquiring or in-licensing additional products or product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; the challenges of protecting and enhancing our intellectual property rights; and complying with applicable regulatory requirements. See the section titled “Risk Factors” located elsewhere in this report for additional information.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
The market risk inherent in our financial instruments and in our financial position represents the potential loss arising from adverse changes in interest rates. As of June 30, 2026, we had cash, cash equivalents and short- and long-term investments of $575.1 million consisting of $336.5 million of overnight investments, interest-bearing money market funds, short- and long-term investments of $238.6 million, consisting of commercial paper, highly rated corporate bonds and treasuries. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. The primary objectives of our investment activities are to ensure liquidity and to preserve principal while at the same time maximizing the interest income, we receive from our marketable securities without significantly increasing risk. We have established guidelines regarding approved investments and maturities of investments, which are designed to maintain safety and liquidity. Due to the relative short-term maturities of our cash equivalents and the low risk profile of our short and long-term investments, an immediate 100 basis point change in interest rates would not have a material effect on the fair market value of our cash equivalents and short and long-term investments. We have the ability to hold our investments until maturity, and therefore, we would not expect our operating results or cash flows to be affected to any significant degree by the effect of a change in market interest rates on our investment portfolio.
We do not believe that inflation and changing prices had a significant impact on our results of operations for any periods presented herein.
Item 4. Controls and Procedures
Disclosure Controls and Procedures and Internal Control over Financial Reporting
Controls and Procedures
We have carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act), as of June 30, 2026. Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures are effective in ensuring that:
(a)the information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms; and
(b)the information is accumulated and communicated to our management, including our principal executive officer and principal financial officer as appropriate to allow timely decisions regarding required disclosure.
In designing and evaluating our disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting during the quarter ended June 30, 2026, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.