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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
| | | | | |
| ☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| For the quarterly period ended September 30, 2026 |
| OR |
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| For the transition period from to |
Commission File Number: 001-39071
ADC Therapeutics SA
(Exact name of registrant as specified in its charter)
| | | | | |
| Switzerland | Not Applicable |
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
| |
Biopôle Route de la Corniche 3B 1066 Epalinges Switzerland (Address of principal executive offices) (Zip code) |
+41 21 653 02 00 (Registrant’s telephone number) |
N/A
(Former name or former address, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
| | | | | | | | | | | | | | |
| Title of each class | | Trading symbol(s) | | Name of each exchange on which registered |
| Common Shares, par value CHF 0.08 per share | | ADCT | | The New York Stock Exchange |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| | | | | | | | | | | | | | | | | | | | |
| Large accelerated filer | | ☐ | | Accelerated filer | | ☐ |
| Non-accelerated filer | | ☒ | | Smaller reporting company | | ☒ |
| | | | Emerging growth company | | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The number of common shares outstanding was 140,661,880 as of November 2, 2026.
Table of Contents
| | | | | |
PART I: FINANCIAL INFORMATION | 1 |
Condensed Consolidated Balance Sheets (Unaudited) - September 30, 2026 and December 31, 2025 | 1 |
Condensed Consolidated Statements of Operations (Unaudited) - Three and nine months ended September 30, 2026 and 2025 | 2 |
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - Three and nine months ended September 30, 2026 and 2025 | 3 |
Condensed Consolidated Statements of Changes in Shareholders’ (Deficit) Equity (Unaudited) - Three and nine months ended September 30, 2026 and 2025 | 4 |
Condensed Consolidated Statements of Cash Flows (Unaudited) - Nine months ended September 30, 2026 and 2025 | 6 |
Notes to the Condensed Consolidated Financial Statements (Unaudited) | 7 |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations | 23 |
Item 3. Quantitative and Qualitative Disclosures About Market Risk | 35 |
Item 4. Controls and Procedures | 35 |
PART II: OTHER INFORMATION | 35 |
Item 1. Legal Proceedings | 35 |
Item 1A. Risk Factors | 36 |
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds | 36 |
Item 3. Defaults Upon Senior Securities | 36 |
Item 4. Mine Safety Disclosures | 36 |
Item 5. Other Information | 36 |
Item 6. Exhibits | 37 |
Signatures | 38 |
Unless otherwise indicated or the context otherwise requires, all references in this Quarterly Report to “ADC Therapeutics,” “ADCT,” the “Company,” “we,” “our,” “ours,” “us” or similar terms refer to ADC Therapeutics SA and its consolidated subsidiaries.
FORWARD-LOOKING STATEMENTS
This Quarterly Report contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future catalysts, results of operations and financial position, business and commercial strategy, market opportunities, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, research and development costs, projected revenues and expenses and the timing of revenues and expenses, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Many of the forward-looking statements contained in this Quarterly Report can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “will” and “potential,” among others.
Forward-looking statements are based on our management’s beliefs and assumptions and on information available to our management at the time such statements are made. Such statements are subject to known and unknown risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to:
•the substantial net losses that we have incurred since our inception, our expectation to continue to incur losses for the foreseeable future and our need to raise additional capital to fund our operations and execute our business plan, which will depend on financial, economic and market conditions, the number of authorized shares, and other factors, over which we may have no or limited control;
•our indebtedness under the loan agreement and guaranty (the “Loan Agreement”) with certain affiliates and/or funds managed by each of Oaktree Capital Management, L.P. and Owl Rock Capital Advisors LLC, as lenders, and Blue Owl Opportunistic Master Fund I, L.P., as administrative agent, and the associated restrictive covenants thereunder;
•the purchase and sale agreement with certain entities managed by HealthCare Royalty Management, LLC (“HCR”) and its negative effect on the amount of cash that we are able to generate from sales of, and licensing agreements involving, ZYNLONTA and on our attractiveness as an acquisition target;
•the uncertainties of international trade policies, including tariffs, sanctions, trade barriers and most favored nation drug pricing;
•our ability to complete clinical trials on expected timelines, if at all;
•the timing, outcome and results of ongoing or planned clinical trials and the sufficiency of such results;
•undesirable side effects or adverse events of our products and product candidates;
•our and our partners’ ability, and clinical trial data’s sufficiency, to obtain and maintain regulatory approval for our product and product candidates;
•our ability to identify and execute on potential regulatory and compendia pathways;
•the timing, content and outcome of meetings with and feedback or other communications provided by regulatory authorities;
•our and our partners’ ability to successfully commercialize our products;
•the availability and scope of coverage and reimbursement for our products;
•the complexity and difficulty of manufacturing our products and product candidates;
•the substantial competition in our industry, including new technologies and therapies;
•our ability to continue to fund, or enter into collaborative or partnership arrangements for our research programs, and the timing, results and future clinical outcomes of such research programs;
•our reliance on third parties for preclinical studies and clinical trials and for the manufacture, production, storage and distribution of our products and product candidates and certain commercialization activities for our products;
•our ability to obtain, maintain and protect our intellectual property rights and our ability to operate our business without infringing on the intellectual property rights of others;
•our estimates regarding future revenue, expenses, liquidity, capital resources and needs for additional financing;
•the size and growth potential of the markets for our products and product candidates;
•potential product liability lawsuits and product recalls for our products;
•and those identified in the “Item 1A. Risk Factors” of our Annual Report on Form 10-K, and in our other reports filed with the U.S. Securities and Exchange Commission (the “SEC”), from time to time thereafter.
Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as
required by applicable law, we do not plan to publicly update or revise any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.
PART I: FINANCIAL INFORMATION
Item 1. Financial Statements
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(in thousands, except share amounts)
| | | | | | | | | | | |
| September 30, 2026 | | December 31, 2025 |
| ASSETS | | | |
| Current assets | | | |
Cash and cash equivalents | $ | 189,204 | | | $ | 261,338 | |
| Accounts receivable, net | 28,417 | | | 29,117 | |
| Inventory | 5,626 | | | 4,184 | |
| Prepaid expenses | 12,144 | | | 5,612 | |
Other current assets | 3,187 | | | 6,084 | |
Total current assets | 238,578 | | | 306,335 | |
| Inventory, long-term | 15,045 | | | 14,301 | |
| | | |
Operating lease right-of-use assets | 1,003 | | | 1,297 | |
| | | |
Other long-term assets | 1,237 | | | 1,217 | |
Total assets | $ | 255,863 | | | $ | 323,150 | |
| LIABILITIES AND SHAREHOLDERS’ (DEFICIT) EQUITY | | | |
| Current liabilities | | | |
Accounts payable | $ | 5,582 | | | $ | 9,175 | |
Accrued expenses and other current liabilities | 64,743 | | | 57,988 | |
| | | |
| Senior secured term loans, current portion | 7,800 | | | 3,000 | |
Total current liabilities | 78,125 | | | 70,163 | |
| Deferred royalty obligation, long-term | 303,488 | | | 322,525 | |
| Senior secured term loans, long-term | 108,304 | | | 112,452 | |
| Warrant obligations | 5,381 | | | — | |
| | | |
| Other long-term liabilities | 9,738 | | | 3,844 | |
Total liabilities | 505,036 | | | 508,984 | |
Commitments and contingencies (See Note 9) | | | |
| Shareholders’ (deficit) equity | | | |
Common shares, at CHF 0.08 par value | 11,261 | | | 11,080 | |
Issued shares: 130,068,778 at September 30, 2026 and 128,310,010 at December 31, 2025; outstanding shares: 127,737,677 at September 30, 2026 and 125,748,762 at December 31, 2025 | | | |
Additional paid-in capital | 1,451,368 | | | 1,439,749 | |
Treasury shares | (187) | | | (205) | |
At September 30, 2026: 2,331,101 and December 31, 2025: 2,561,248 | | | |
Accumulated other comprehensive loss | (837) | | | (517) | |
Accumulated deficit | (1,710,778) | | | (1,635,941) | |
Total shareholders’ (deficit) equity | (249,173) | | | (185,834) | |
Total liabilities and shareholders’ (deficit) equity | $ | 255,863 | | | $ | 323,150 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
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| ADC Therapeutics SA |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands, except share and per share amounts)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2026 | | 2025 | | 2026 | | 2025 |
| Revenue | | | | | | | |
| Product revenues, net | $ | 21,006 | | | $ | 15,750 | | | $ | 59,673 | | | $ | 51,239 | |
| License revenues and royalties | 710 | | | 677 | | | 2,142 | | | 7,060 | |
| Total revenue, net | 21,716 | | | 16,427 | | | 61,815 | | | 58,299 | |
| Operating expense | | | | | | | |
| Cost of product sales | (1,980) | | | (1,202) | | | (7,944) | | | (4,099) | |
| Research and development | (14,738) | | | (26,803) | | | (51,981) | | | (85,821) | |
| Selling and marketing | (8,674) | | | (10,688) | | | (33,954) | | | (31,388) | |
| General and administrative | (10,736) | | | (8,326) | | | (30,333) | | | (27,103) | |
| Restructuring, impairment and other related costs | 62 | | | (377) | | | (2,612) | | | (13,468) | |
| Total operating expense | (36,066) | | | (47,396) | | | (126,824) | | | (161,879) | |
| Loss from operations | (14,350) | | | (30,969) | | | (65,009) | | | (103,580) | |
| Other income (expense) | | | | | | | |
| Interest income | 1,618 | | | 2,470 | | | 5,431 | | | 6,458 | |
| Interest expense | (13,733) | | | (13,392) | | | (39,590) | | | (38,619) | |
| Other, net | 1,161 | | | 925 | | | 24,331 | | | 946 | |
| | | | | | | |
| Total other income (expense), net | (10,954) | | | (9,997) | | | (9,828) | | | (31,215) | |
Loss before income taxes | (25,304) | | | (40,966) | | | (74,837) | | | (134,795) | |
| Income tax expense | — | | | — | | | — | | | (1,419) | |
| Net loss | $ | (25,304) | | | $ | (40,966) | | | $ | (74,837) | | | $ | (136,214) | |
Net loss per share | | | | | | | |
Net loss per share, basic and diluted | $ | (0.16) | | | $ | (0.30) | | | $ | (0.48) | | | $ | (1.14) | |
Weighted average shares outstanding, basic and diluted | 155,410,275 | | 136,446,534 | | 154,860,859 | | 119,237,877 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
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| ADC Therapeutics SA |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
(in thousands)
| | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, | | |
| 2026 | | 2025 | | 2026 | | 2025 | | |
Net loss | $ | (25,304) | | | $ | (40,966) | | | $ | (74,837) | | | $ | (136,214) | | | |
| | | | | | | | | |
| Other comprehensive (loss) income: | | | | | | | | | |
| Remeasurement of defined benefit pension liability | (41) | | | (47) | | | (128) | | | (136) | | | |
Foreign currency translation adjustment | 18 | | | (267) | | | (192) | | | 855 | | | |
| | | | | | | | | |
| | | | | | | | | |
| Other comprehensive (loss) income | (23) | | | (314) | | | (320) | | | 719 | | | |
| | | | | | | | | |
| Total comprehensive loss | $ | (25,327) | | | $ | (41,280) | | | $ | (75,157) | | | $ | (135,495) | | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
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| ADC Therapeutics SA |
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ (DEFICIT) EQUITY
(Unaudited)
(in thousands, except share and per share amounts)
Three and Nine Months Ended September 30, 2026
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| (in thousands, except share amounts) | | | Number of shares | | Common shares, par value | | Additional paid-in capital | | Number of shares (held or received)/delivered | | Treasury shares | | Accumulated other comprehensive (loss) income | | Accumulated deficit | | Total | |
| Balance as of June 30, 2026 | | | 129,999,421 | | | $ | 11,254 | | | $ | 1,447,034 | | | (2,561,248) | | | $ | (205) | | | $ | (814) | | | $ | (1,685,474) | | | $ | (228,205) | | |
| Loss for the period | | | — | | | — | | | — | | | — | | | — | | | — | | | (25,304) | | | (25,304) | | |
| Other comprehensive loss | | | — | | | — | | | — | | | — | | | — | | | (23) | | | — | | | (23) | | |
| | | | | | | | | | | | | | | | | | |
| Exercise of stock options | | | 11,515 | | | 1 | | | 6 | | | 5,313 | | | — | | | — | | | — | | | 7 | | |
| Exercise of warrants | | | 57,842 | | | 6 | | | (6) | | | — | | | — | | | — | | | — | | | — | | |
| Issuance of shares, 2022 Employee Stock Purchase Plan | | | — | | | — | | | 187 | | | 224,834 | | | 18 | | | — | | | — | | | 205 | | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| Share-based compensation expense | | | — | | | — | | | 4,147 | | | — | | | — | | | — | | | — | | | 4,147 | | |
| Balance as of September 30, 2026 | | | 130,068,778 | | | $ | 11,261 | | | $ | 1,451,368 | | | (2,331,101) | | | $ | (187) | | | $ | (837) | | | $ | (1,710,778) | | | $ | (249,173) | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| (in thousands, except share amounts) | | | Number of shares | | Common shares, par value | | Additional paid-in capital | | Number of shares (held or received)/delivered | | Treasury shares | | Accumulated other comprehensive (loss) income | | Accumulated deficit | | Total | |
| Balance as of December 31, 2025 | | | 128,310,010 | | | $ | 11,080 | | | $ | 1,439,749 | | | (2,561,248) | | | $ | (205) | | | $ | (517) | | | $ | (1,635,941) | | | $ | (185,834) | | |
| Loss for the period | | | — | | | — | | | — | | | — | | | — | | | — | | | (74,837) | | | (74,837) | | |
| Other comprehensive loss | | | — | | | — | | | — | | | — | | | — | | | (320) | | | — | | | (320) | | |
| Vesting of RSUs | | | 1,502,032 | | | 155 | | | (155) | | | — | | | — | | | — | | | — | | | — | | |
| Exercise of stock options | | | 198,894 | | | 20 | | | 310 | | | 5,313 | | | — | | | — | | | — | | | 330 | | |
| Exercise of warrants | | | 57,842 | | | 6 | | | (6) | | | — | | | — | | | — | | | — | | | — | | |
| Issuance of shares, 2022 Employee Stock Purchase Plan | | | — | | | — | | | 187 | | | 224,834 | | | 18 | | | — | | | — | | | 205 | | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| Share-based compensation expense | | | — | | | — | | | 11,283 | | | — | | | — | | | — | | | — | | | 11,283 | | |
| Balance as of September 30, 2026 | | | 130,068,778 | | | $ | 11,261 | | | $ | 1,451,368 | | | (2,331,101) | | | $ | (187) | | | $ | (837) | | | $ | (1,710,778) | | | $ | (249,173) | | |
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| ADC Therapeutics SA |
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ (DEFICIT) EQUITY (CONT.)
(Unaudited)
(in thousands, except share and per share amounts)
Three and Nine Months Ended September 30, 2025
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| (in thousands, except share amounts) | | | Number of shares | | Common shares, par value | | Additional paid-in capital | | Number of shares (held or received)/delivered | | Treasury shares | | Accumulated other comprehensive (loss) income | | Accumulated deficit | | Total | |
| Balance as of June 30, 2025 | | | 115,080,481 | | | $ | 9,753 | | | $ | 1,380,224 | | | (2,581,398) | | | $ | (207) | | | $ | (388) | | | $ | (1,588,566) | | | $ | (199,184) | | |
| Loss for the period | | | — | | | — | | | — | | | — | | | — | | | — | | | (40,966) | | | (40,966) | | |
| Other comprehensive loss | | | — | | | — | | | — | | | — | | | — | | | (314) | | | — | | | (314) | | |
| | | | | | | | | | | | | | | | | | |
| Exercise of stock options | | | 107,498 | | | 10 | | | 270 | | | 20,150 | | | 2 | | | — | | | — | | | 282 | | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| Share-based compensation expense | | | — | | | — | | | 1,999 | | | — | | | — | | | — | | | — | | | 1,999 | | |
| Balance as of September 30, 2025 | | | 115,187,979 | | | $ | 9,763 | | | $ | 1,382,493 | | | (2,561,248) | | | $ | (205) | | | $ | (702) | | | $ | (1,629,532) | | | $ | (238,183) | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| (in thousands, except share amounts) | | | Number of shares | | Common shares, par value | | Additional paid-in capital | | Number of shares (held or received)/delivered | | Treasury shares | | Accumulated other comprehensive (loss) income | | Accumulated deficit | | Total | |
| Balance as of December 31, 2024 | | | 101,606,376 | | | $ | 8,425 | | | $ | 1,283,892 | | | (2,744,974) | | | $ | (220) | | | $ | (1,421) | | | $ | (1,493,318) | | | $ | (202,642) | | |
| Loss for the period | | | — | | | — | | | — | | | — | | | — | | | — | | | (136,214) | | | (136,214) | | |
| Other comprehensive income | | | — | | | — | | | — | | | — | | | — | | | 719 | | | — | | | 719 | | |
| Vesting of RSUs | | | 424,379 | | | 41 | | | (41) | | | — | | | — | | | — | | | — | | | — | | |
| Exercise of stock options | | | 126,063 | | | 12 | | | 301 | | | 20,150 | | | 2 | | | — | | | — | | | 315 | | |
| Issuance of shares, 2022 Employee Stock Purchase Plan | | | — | | | — | | | 258 | | | 163,576 | | | 13 | | | — | | | — | | | 271 | | |
| Issuance of shares, underwritten offering, net of transaction costs | | | 13,031,161 | | | 1,285 | | | 41,091 | | | — | | | — | | | — | | | — | | | 42,376 | | |
| Issuance of warrants, underwritten offering, net of transaction costs | | | — | | | — | | | 50,760 | | | — | | | — | | | — | | | — | | | 50,760 | | |
| Share-based compensation expense | | | — | | | — | | | 6,232 | | | — | | | — | | | — | | | — | | | 6,232 | | |
| Balance as of September 30, 2025 | | | 115,187,979 | | | $ | 9,763 | | | $ | 1,382,493 | | | (2,561,248) | | | $ | (205) | | | $ | (702) | | | $ | (1,629,532) | | | $ | (238,183) | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
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| ADC Therapeutics SA |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(in thousands)
| | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2026 | | 2025 |
| Cash flows from operating activities | | | |
| Net loss | $ | (74,837) | | | $ | (136,214) | |
| Adjustments to reconcile net loss to net cash used in operations: | | | |
| | | |
| Share-based compensation expense | 11,083 | | | 6,232 | |
| Accretion expense of deferred royalty obligation | 21,886 | | | 21,348 | |
| Cumulative catch-up adjustment, deferred royalty obligation | (8,907) | | | (517) | |
Impairment of long-lived assets and prepaid expenses and other related costs | — | | | 7,240 | |
| Write-downs of inventory | 1,932 | | | 1,873 | |
| | | |
| | | |
| | | |
| | | |
| | | |
| Warrant obligations, decrease in fair value | (15,372) | | | — | |
| Amortization of debt discount, senior secured term loan | 2,152 | | | 1,574 | |
| Other | (300) | | | 2,189 | |
| Changes in operating assets and liabilities: | | | |
| Accounts receivable, net | 699 | | | (2,602) | |
| Inventory | (3,917) | | | (1,528) | |
| Prepaid expenses and other current assets | (3,548) | | | 5,448 | |
| Other long-term assets | — | | | (46) | |
| Accounts payable | (2,766) | | | (9,970) | |
| Accrued expenses and other current liabilities | (3,171) | | | (9,394) | |
| | | |
| Operating lease liabilities | (469) | | | (1,994) | |
| Other long-term liabilities | 6,140 | | | 6,310 | |
| Net cash used in operating activities | (69,395) | | | (110,051) | |
| Cash flows from investing activities | | | |
| Payment for purchases of property and equipment | (32) | | | (264) | |
| Net cash used in investing activities | (32) | | | (264) | |
| Cash flows from financing activities | | | |
Principal payments of senior secured term loans | (1,500) | | | — | |
| Proceeds from the sale of common shares, net of transaction costs | (837) | | | 42,760 | |
| Proceeds from Pre-Funded Warrants, net of transaction costs | — | | | 50,760 | |
| | | |
| Proceeds from share issuance under stock purchase plan | 205 | | | 271 | |
| Proceeds from the exercise of stock options | 330 | | | 315 | |
| Taxes paid related to net settled equity awards | (985) | | | (250) | |
| Net cash (used in)/ provided by financing activities | (2,787) | | | 93,856 | |
| Net increase (decrease) in cash and cash equivalents | (72,214) | | | (16,459) | |
| Exchange (losses)/gains on cash and cash equivalents | 80 | | | 330 | |
| Cash and cash equivalents at beginning of period | 261,338 | | | 250,867 | |
| Cash and cash equivalents at end of period | $ | 189,204 | | | $ | 234,738 | |
| Supplemental cash flow information: | | | |
| Interest paid | $ | 10,330 | | | $ | 10,882 | |
| Interest received | 5,431 | | | 6,458 | |
| Payments made under royalty financing transaction | 5,222 | | | 4,816 | |
| Supplemental non-cash investing and financing activities: | | | |
| Capitalized share-based compensation | 200 | | | — | |
| Transaction costs recorded in accounts payable and other current liabilities and other long-term liabilities | — | | | 384 | |
| | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
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| ADC Therapeutics SA |
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
| (Unaudited) |
| (in thousands, except share and per share amounts) |
1.Description of Business and Organization
ADC Therapeutics is a commercial-stage global pioneer in the field of antibody drug conjugates (“ADCs”), transforming treatment for patients through our focused portfolio with ZYNLONTA ® (loncastuximab tesirine-lpyl), a CD19-directed ADC.
The Company generates sales from its flagship product, ZYNLONTA which received accelerated approval from the U.S. Food and Drug Administration (“FDA”), conditional approval from the European Commission, the China National Medical Products Administration (“NMPA”) and Health Canada, as well as approvals in other key global markets for the treatment of relapsed or refractory diffuse large B-cell lymphoma (“DLBCL”) after two or more lines of systemic therapy. Additionally, the Company is pursuing expansion into earlier lines of therapies and indolent lymphomas through Company sponsored trials and investigator initiated studies.
The Company was incorporated on June 6, 2011 under the laws of Switzerland, with its registered office located at Route de la Corniche 3B, 1066 Epalinges, Switzerland. The Company has two wholly-owned subsidiaries: ADC Therapeutics America, Inc. (“ADCT America”), which was incorporated in Delaware, USA on December 10, 2014 and ADC Therapeutics (UK) Ltd (“ADCT UK”), incorporated in England on December 12, 2014. The Company and its two subsidiaries form the ADCT Group (the “Group”).
All references to “ADC Therapeutics,” “ADCT,” “the Company," “we,” “us,” and “our” refer to ADC Therapeutics SA and its consolidated subsidiaries unless otherwise indicated.
2.Summary of Significant Accounting Policies
Basis of preparation and principles of consolidation
These accompanying unaudited condensed consolidated financial statements, which include the accounts of the Company and its wholly-owned subsidiaries, have been prepared following the requirements of the U.S. Securities and Exchange Commission for interim reporting. As permitted under those rules, certain footnotes and other financial information that are normally required by U.S. generally accepted accounting principles, or U.S. GAAP, can be condensed or omitted. All intercompany transactions and balances have been eliminated in consolidation. The information included in this Quarterly Report on Form 10‑Q should be read in conjunction with our annual audited consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10‑K for the year ended December 31, 2025.
In the opinion of management, these condensed consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and include all adjustments, consisting only of normal recurring adjustments, considered necessary for the fair statement of our financial position and operating results. The results for the three and nine months ended September 30, 2026 are not necessarily indicative of the results to be expected for the year ending December 31, 2026, for any other interim period or for any future period.
The Company’s significant accounting policies have not changed substantially from those previously described in the Company’s Annual Report on Form 10‑K for the year ended December 31, 2025.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures in the consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Actual results could differ materially from those estimates.
Loan Modifications and Extinguishments
On February 18, 2026, the Company entered into an amendment to its royalty purchase agreement with certain entities managed by HealthCare Royalty Management, LLC ("HCR"). Prior to the amendment, the agreement was accounted for as a debt obligation. The Company evaluates amendments, restructurings, or other changes to its loan agreements
in accordance with ASC 470-50, Debt — Modifications and Extinguishments. Under this guidance, we determine whether the revised terms represent a modification of the existing debt or an extinguishment of the old debt and issuance of new debt. If the changes are not deemed substantial, the transaction is accounted for as a modification and any associated fees or costs with the lender are amortized over the remaining term of the modified debt. If the changes are deemed to be substantial, the original debt is considered extinguished, and the new debt is recorded at fair value and any resulting difference between the carrying amount of the old debt and the fair value of the new debt is recognized in earnings as a gain or loss on extinguishment. When the Company repays an existing debt obligation using the proceeds from a contemporaneous issuance of new debt to a different lender, we account for the transaction as a debt extinguishment. See Note 7 for additional information regarding the HCR amendment and related accounting treatment.
Cost of product sales
Cost of product sales includes costs directly and indirectly relating to the manufacture of ZYNLONTA commercial drug substance and drug product, including the third-party manufacture costs of our contract manufacturing organizations (“CMOs”), as well as internal personnel costs, including share-based compensation, associated with the production of ZYNLONTA. Cost of product sales also includes royalties payable to a collaboration partner based on net product sales of ZYNLONTA, idle capacity costs, and inventory write-downs for changes in reserves for excess inventory or write-offs of inventory that fail to meet specification. We expect that cost of product sales will continue to increase over time as we sell through pre-approval inventory that was previously expensed prior to commercialization under U.S. GAAP. Factors such as inflation, tariffs and other external factors may also increase our cost of product sales.
Recent Accounting Pronouncements
New accounting pronouncements which have been adopted
We adopted FASB ASU-2025-05, Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets to simplify the estimation of credit losses on current accounts receivable and current contract assets arising from transactions accounted for under ASC 606, effective for fiscal years beginning in January 2026, including interim periods within those fiscal years. The ASU provides a practical expedient permitting an entity to assume that conditions at the balance sheet date remain unchanged over the life of the asset when estimating expected credit losses for current classified accounts receivable and contract assets. We adopted the practical expedient on a prospective basis for the quarterly and annual reports for the fiscal year beginning on January 1, 2026. Adoption of this standard did not have a material impact on our financial statements or disclosures.
Issued but not yet adopted
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses Disclosure. The ASU requires disaggregation, in the notes to the financial statements, of certain cost and expense captions presented on the face of the Company’s interim and annual financial statements. ASU 2024-03 is effective for fiscal years beginning in January 2027 and interim periods beginning January 2028, with early adoption permitted. Adoption may be applied prospectively or retrospectively. The Company does not anticipate that the adoption of this standard will have a material impact on our financial statements but may result in enhanced or expanded disclosures.
In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements. The ASU clarifies interim disclosure requirements, the applicability of ASC 270 and the form and content of interim financial statements in accordance with U.S. GAAP. The objective of the amendments is to provide further clarity about the current interim disclosure requirements. The ASU is effective for interim reporting periods within fiscal years beginning in January 2028. Adoption of this ASU may be applied prospectively or retrospectively. The Company is currently evaluating the impact of the ASU, but does not anticipate the adoption of this standard to have a material impact on our financial statements.
In December 2025, the FASB issued ASU 2025-12, Codification Improvements. The ASU addresses thirty-three items, representing the changes to the Codification that (1) clarify, (2) correct errors, or (3) make minor improvements. Generally, the amendments in this ASU are not intended to result in significant changes for most entities. The ASU is effective for interim reporting periods within annual reporting periods beginning in January 2027, with early adoption permitted. The adoption method of this ASU may vary, on an issue-by-issue basis. The Company is currently
evaluating the impact of the ASU, but does not anticipate the adoption of this standard to have a material impact on our financial statements.
3.Fair value measurements
The carrying amount of cash and cash equivalents, accounts receivable, net and accounts payable is a reasonable approximation of fair value due to the short-term nature of these assets and liabilities. Financial liabilities that are not measured at fair value on a recurring basis include our senior secured term loan and deferred royalty financing obligation. The carrying value of our senior secured term loan approximates fair value as these borrowings are based on variable market rates. The carrying value of our deferred royalty obligation approximates fair value as the loan is recorded using the amortized cost method and considers our current estimates of future royalties expected to be paid over the estimated life of the royalty purchase agreement which are level 3 inputs, adjusted for accretion and royalty payments made by the Company during the nine months ended September 30, 2026.
On February 18, 2026 the Company issued warrants to HCR to purchase 9,834,776 common shares. The HCR warrants are measured at fair value on a recurring basis and are classified as Level 2. As of September 30, 2026 the value of the HCR warrants were $5.4 million. Fair values are estimated at the end of each reporting period with regard to the HCR warrants. The approach to the valuation follows the fair value principle, and the key input factors are described for the HCR warrants in Note 7, “Deferred royalty obligation and warrants.” A Black-Scholes model was used to calculate the fair values.
There were no transfers between the respective levels during the period.
4.Inventory
As of September 30, 2026 and December 31, 2025 inventory consisted of the following:
| | | | | | | | | | | | | | |
| (in thousands) | | September 30, 2026 | | December 31, 2025 |
| | | | |
| Work in progress | | $ | 20,383 | | | $ | 18,390 | |
| Finished goods | | 288 | | | 95 | |
| Total inventory, net | | $ | 20,671 | | | $ | 18,485 | |
Less long-term portion (1) | | 15,045 | | | 14,301 | |
| Total inventory, current | | $ | 5,626 | | | $ | 4,184 | |
(1) Inventory expected to be sold beyond the Company’s 12-month operating cycle is classified as non-current inventory and recorded in inventory, long-term.
Inventory write-downs of $288 and $1,932 were recognized for the three and nine months ended September 30, 2026 respectively, and charged to cost of product sales in the Company’s unaudited condensed consolidated statements of operations. Inventory write-downs of $237 and $1,873 were recognized for the three and nine months ended September 30, 2025, respectively, and charged to cost of product sales in the Company’s unaudited condensed consolidated statements of operations.
5.Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consist of the following:
| | | | | | | | | | | | | | |
| (in thousands) | | September 30, 2026 | | December 31, 2025 |
Accrued R&D costs | | $ | 22,329 | | | $ | 18,904 | |
Accrued payroll and benefits | | 8,482 | | | 13,257 | |
| Accrued restructuring costs | | — | | | 2,159 | |
| Deferred royalty obligation, short-term | | 22,317 | | | 11,054 | |
| Gross-to-net sales adjustments, short-term | | 8,576 | | | 9,020 | |
| | | | |
Other | | 3,039 | | | 3,594 | |
| | $ | 64,743 | | | $ | 57,988 | |
6.Senior secured term loan facility and warrants
On August 15, 2022, the Company, ADCT UK and ADCT America entered into the Loan Agreement with certain affiliates and/or funds managed by each of Oaktree Capital Management, L.P. and Owl Rock Capital Advisors LLC, as lenders, and Owl Rock Opportunistic Master Fund I, L.P., as administrative agent and collateral agent, pursuant to which the Company may borrow up to $175.0 million principal amount of secured term loans, including (i) a First Tranche and (ii) Future Tranches. On August 15, 2022, the Company drew down $120.0 million principal amount of term loans under the Loan Agreement.
On August 15, 2022, the Company also issued to the lenders under the Loan Agreement warrants to purchase an aggregate of 527,295 common shares, which warrants have an exercise price of $8.30 per share (the “Lender Warrants”). Each warrant is exercisable, on a cash or a cashless basis, at the option of the holder at any time on or prior to August 15, 2032. The warrants are freestanding financial instruments that are indexed to the Company’s common stock and meet all other conditions for equity classification under ASC 480 and ASC 815. Accordingly, these warrants are recognized in equity and accounted for as a component of additional paid-in capital at the time of issuance.
On August 15, 2022, the Company also entered into the Share Purchase Agreement with the lenders under the Loan Agreement to purchase 733,568 common shares of the Company.
For the three and nine months ended September 30, 2026, the Company recorded interest expense on the senior secured term loan in the amount of $4,477 and $12,482, respectively, and $4,396 and $12,455 for the three and nine months ended September 30, 2025, respectively, which was recorded in interest expense in the unaudited condensed consolidated statements of operations. The effective interest rate (“EIR”) was 16.00% and 16.01% at September 30, 2026 and 2025, respectively.
The following table provides a summary of the interest expense for the Company’s senior secured term loan for the three and nine months ended September 30, 2026 and 2025:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2026 | | 2025 | | 2026 | | 2025 |
| Contractual interest expense | | $ | 3,490 | | | $ | 3,663 | | | $ | 10,330 | | | $ | 10,881 | |
| Amortization of debt discount | | 987 | | | 733 | | | 2,152 | | | 1,574 | |
| Total | | $ | 4,477 | | | $ | 4,396 | | | $ | 12,482 | | | $ | 12,455 | |
The amount at which the senior secured term loan is presented as a liability in the unaudited condensed consolidated balance sheets represents the net present value of all future cash outflows associated with the loan discounted at the EIR. The carrying value of the senior secured term loan is $116.1 million and $115.5 million as of September 30, 2026 and December 31, 2025, respectively. First principal payment of $1.5 million was paid on September 30, 2026, with $7.8 million and $3.0 million due within 12 months classified as a current liability within the "Senior secured term loans, current portion” line item on the unaudited consolidated balance sheets as of September 30, 2026 and December 31, 2025, respectively.
Contractual payments due under our senior secured term loans, including exit fees are as follows (in thousands):
| | | | | | | | |
| 2026 (remainder) | | 1,590 | |
| 2027 | | 9,330 | |
| 2028 | | 12,480 | |
| 2029 | | 99,840 | |
| Total | | $ | 123,240 | |
See Note 16, “Subsequent events” for further information.
7.Deferred royalty obligation and warrants
On August 25, 2021, the Company entered into a royalty purchase agreement with certain entities managed by HCR for up to $325.0 million. Under the terms of the agreement, the Company received gross proceeds of $225.0 million upon closing (the “First Investment Amount”) and received an additional $75.0 million during the year ended December 31, 2023 upon the first commercial sale of ZYNLONTA in the United Kingdom or any European Union country (the “Second Investment Amount”) and together with the First Investment Amount, the “Investment Amount”).
On February 18, 2026, the Company entered into an amendment (the “First HCR Amendment”) to the Purchase and Sale Agreement, dated August 25, 2021 (the “Original HCR Agreement” and, as amended by the HCR Amendment, the “Amended HCR Agreement”). Under the Original Agreement, upon the occurrence of a change of control event, the Company is obligated to pay HCR $750 million (or $675 million if HCR receives royalty payments exceeding a mid-nine-digit amount on or prior to March 31, 2029), less the amount of royalties previously paid to HCR. Under the Amended HCR Agreement, upon the occurrence of a change of control event, the Company is obligated to pay HCR $150 million (if the change of control event occurs on or before December 31, 2027) or $200 million (if the change of control event occurs on or after January 1, 2028), which amount is not reduced by the amount of royalties previously paid to HCR. In addition, following such change of control event, the royalty obligations under the Amended HCR Agreement will continue until the Royalty Cap (as defined in the Original HCR Agreement), unless the Company (or its successor in interest) buys out the remaining royalty obligations by paying HCR $525 million (if the buyout occurs on or prior to December 31, 2029) or $750 million (if the buyout occurs on or after January 1, 2030), less the amount of royalties previously paid to HCR and the change of control payment described above.
In connection with the First HCR Amendment, the Company issued to HCR warrants (the “HCR Warrants”) to purchase 9,834,776 common shares. The HCR Warrants are exercisable at any time after their original issuance until December 31, 2030. The exercise price per common share purchasable upon the exercise of the HCR Warrants is $3.81 per share, subject to customary adjustments. The HCR Warrants have certain limitations on exercise, including (i) any exercise must be for at least 50,000 common shares (or, if less, the remaining common shares available for purchase under the HCR Warrants) and (ii) cashless exercise is not available in certain circumstances as specified in the HCR Warrants. The HCR Warrants contain customary anti-dilution adjustments and will entitle holders to receive any dividends or other distributions paid on the underlying common shares prior to their expiration on an as-exercised basis. The HCR Warrants and any common shares issuable upon exercise of the warrants are not transferable on or prior to December 31, 2027, except, with respect to common shares issued upon exercise of the warrants, in connection with the consummation of certain fundamental transactions.
Accounting for the First HCR Amendment
The Company assessed the First HCR amendment for a debt extinguishment or modification in accordance with ASC-470-50. The fair value of the warrants issued was determined to be $20.8 million at the time of issuance. The First HCR amendment was accounted for as a debt modification as the present value of future cashflows of the modified agreement compared to that of the original agreement resulted in a less than 10% change. As a result, the Company did not incur any gain or loss relating to the modification. The fair value of the warrants is presented as a direct reduction to the carrying value of the debt. The Company will continue to account for the value of the debt at amortized cost.
The Company determined the fair value of the warrants at issuance on February 18, 2026 by using the Black-Scholes model with the following key assumptions:
| | | | | |
| As of |
| February 18, 2026 |
| Exercise price in $ | 3.81 |
| Share price in $ | 4.13 |
| Risk-free interest rate | 3.7 | % |
| Expected volatility | 98.1 | % |
| Expected term (years) | 4.87 |
| Dividend yield | — | |
| Discount for lack of marketability | 32.3 | % |
| Black-Scholes value in $ | 2.11 |
The table below provides a rollforward of the Company’s debt obligation relating to the royalty purchase agreement.
| | | | | | | | |
| (in thousands) | | |
| Balance as of December 31, 2024 | | $ | 326,659 | |
| Less: royalty payments | | (6,214) | |
| Plus: interest expense | | 35,346 | |
| Less: cumulative catch-up adjustment, Other, net | | (22,212) | |
| Balance as of December 31, 2025 | | 333,579 | |
| Less: Fair value of HCR warrants at time of issuance | | (20,753) | |
| Less: royalty payments | | (5,222) | |
| Plus: interest expense | | 27,108 | |
| Less: cumulative catch-up adjustment, Other, net | | (8,907) | |
| Balance as of September 30, 2026 | | $ | 325,805 | |
Accounting for the HCR Warrants (First HCR Amendment)
The HCR Warrants are recognized as a warrant obligation and presented in the unaudited condensed consolidated balance sheet as a liability given the existence of a net settlement feature under which the holder may settle in cash equal to the par value, with the amount payable indexed to the CHF/USD exchange rate, and receive the underlying shares on a net basis. The warrant obligation was recorded at its initial fair value of $20.8 million at the time of issuance as described further above. Subsequent to issuance, the warrant obligation is remeasured to fair value at the end of each reporting period. Changes in the fair value (gains or losses) of the warrant obligation at the end of each period is recorded in the unaudited condensed consolidated statement of operations.
During the three and nine months ended September 30, 2026, the Company recognized expense of $1.2 million and income of $15.4 million, respectively, as a result of changes in the fair value of the warrant obligation. This amount was recorded to Other, net in the unaudited condensed consolidated statement of operations. The fair value of the warrant obligation as of September 30, 2026 was $5.4 million. See Note 12, "Other income (expense)" for further information.
The Company calculated the fair value of the HCR warrant obligation as of September 30, 2026, using the Black-Scholes model. Key inputs for the valuation of the warrant obligation were as follows:
| | | | | |
| As of |
| September 30, 2026 |
| Exercise price in $ | 3.81 |
| Share price in $ | 1.22 |
| Risk-free interest rate | 5.1 | % |
| Expected volatility | 117.5 | % |
| Expected term (years) | 4.25 |
| Dividend yield | — | |
| Discount for lack of marketability | 32.0 | % |
| Black-Scholes value in $ | 0.55 |
See Note 16, “Subsequent events” for further information.
8.Pension and post-retirement benefit obligations
The Swiss employee pension plan is a defined benefit scheme that fully reinsures disability, death, and longevity risks while guaranteeing 100% of capital and interest through vested capital investment. The assets are invested by the pension plan of the collective foundation, to which many companies contribute, in a diversified portfolio that respects the requirements of the Swiss BVG.
Although, as is the case with many Swiss pension plans, the amount of ultimate pension benefit is not defined, certain legal obligations of the plan create constructive obligations on the employer to pay further contributions to fund an eventual deficit; this results in the plan nevertheless being accounted for as a defined benefit plan.
The net periodic benefit cost for the three and nine months ended September 30, 2026 and 2025 is as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| (in thousands) | | 2026 | | 2025 | | 2026 | | 2025 |
| Net periodic benefit cost: | | | | | | | | |
| Service cost | | $ | 137 | | | $ | 208 | | | $ | 421 | | | $ | 605 | |
| Interest cost | | 28 | | | 28 | | | 85 | | | 81 | |
| Expected return on plan assets | | (36) | | | (72) | | | (110) | | | (209) | |
| Amortization of prior service cost | | (41) | | | (47) | | | (128) | | | (136) | |
| Amortization of actuarial losses | | — | | | 5 | | | — | | | 15 | |
| | | | | | | | |
| | | | | | | | |
| Net periodic benefit cost | | $ | 88 | | | $ | 122 | | | $ | 268 | | | $ | 356 | |
The components of net periodic benefit cost are included in operating expense on the unaudited condensed consolidated statements of operations.
9.Commitments and contingencies
Manufacturing Commitments
Some of our inventory components require long lead times to manufacture. Therefore, we make long-term investments in our supply chain in order to ensure we have enough drug product to meet current and future revenue forecasts. Third party manufacturing agreements include non-cancelable obligations related to the supply of ZYNLONTA. There have been no material changes related to our non-cancelable obligations under these arrangements as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.
Contingent liabilities
From time to time, we may be involved in various legal matters generally incidental to our business. Although the results of litigation and claims cannot be predicted with certainty, after discussion with legal counsel, we are not aware of any matters for which the likelihood of a loss is probable and reasonably estimable and which could have a material impact on our consolidated financial condition, liquidity, or results of operations.
10.Revenue
The table below provides a disaggregation of revenues by type and customer location for the three and nine months ended September 30, 2026 and 2025:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| (in thousands) | | 2026 | | 2025 | | 2026 | | 2025 |
| Types of goods and services | | | | | | | | |
| Product revenues, net | | $ | 21,006 | | | $ | 15,750 | | | $ | 59,673 | | | $ | 51,239 | |
| License revenues | | — | | | — | | | — | | | 5,000 | |
| | | | | | | | |
| Royalties | | 710 | | | 677 | | | 2,142 | | | 2,060 | |
| Total revenue | | $ | 21,716 | | | $ | 16,427 | | | $ | 61,815 | | | $ | 58,299 | |
| | | | | | | | |
| Customer Location | | | | | | | | |
| U.S. | | $ | 21,006 | | | $ | 15,750 | | | $ | 59,673 | | | $ | 51,239 | |
EMEA(1) | | 710 | | | 677 | | | 2,142 | | | 7,060 | |
| | | | | | | | |
| Total revenue | | $ | 21,716 | | | $ | 16,427 | | | $ | 61,815 | | | $ | 58,299 | |
(1) Europe, the Middle East and Africa
Product revenues, net
The table below provides a rollforward of the Company’s accruals related to the gross-to-net (“GTN”) sales adjustments for the three and nine months ended September 30, 2026:
| | | | | | | | | | | | | | | | | | | | |
| (in thousands) | | Discarded Drug Rebate | | Other Adjustments | | Total |
| Balance as of June 30, 2026 | | $ | 12,233 | | | $ | 2,094 | | | $ | 14,327 | |
| GTN accruals for current period | | 2,426 | | | 5,827 | | | 8,253 | |
| Prior period adjustments | | 244 | | | (89) | | | 155 | |
| Credits, payments and reclassifications | | — | | | (5,234) | | | (5,234) | |
| Balance as of September 30, 2026 | | $ | 14,903 | | | $ | 2,598 | | | $ | 17,501 | |
| | | | | | |
| Balance as of December 31, 2025 | | $ | 7,964 | | | $ | 2,714 | | | $ | 10,678 | |
| GTN accruals for current period | | 6,695 | | | 15,312 | | | 22,007 | |
| Prior period adjustments | | 244 | | | (768) | | | (524) | |
| Credits, payments and reclassifications | | — | | | (14,660) | | | (14,660) | |
| Balance as of September 30, 2026 | | $ | 14,903 | | | $ | 2,598 | | | $ | 17,501 | |
The table below provides a rollforward of the Company’s accruals related to the gross-to-net (“GTN”) sales adjustments for the three and nine months ended September 30, 2025:
| | | | | | | | | | | | | | | | | | | | |
| (in thousands) | | Discarded Drug Rebate | | Other Adjustments | | Total |
| Balance as of June 30, 2025 | | $ | 11,692 | | | $ | 2,490 | | | $ | 14,182 | |
| GTN accruals for current period | | 1,547 | | | 3,641 | | | 5,188 | |
| Prior period adjustments | | (545) | | | (235) | | | (780) | |
| Credits, payments and reclassifications | | — | | | (3,810) | | | (3,810) | |
| Balance as of September 30, 2025 | | $ | 12,694 | | | $ | 2,086 | | | $ | 14,780 | |
| | | | | | |
| Balance as of December 31, 2024 | | $ | 15,103 | | | $ | 2,386 | | | $ | 17,489 | |
| GTN accruals for current period | | 5,516 | | | 11,651 | | | 17,167 | |
| Prior period adjustments | | (745) | | | (808) | | | (1,553) | |
| Credits, payments and reclassifications | | (7,180) | | | (11,143) | | | (18,323) | |
| Balance as of September 30, 2025 | | $ | 12,694 | | | $ | 2,086 | | | $ | 14,780 | |
The table below provides the classification of the accruals related to the GTN sales adjustment included in the Company’s unaudited condensed consolidated balance sheets as of September 30, 2026 and December 31, 2025.
| | | | | | | | | | | | | | |
| (in thousands) | | September 30, 2026 | | December 31, 2025 |
| Accounts receivable, net | | $ | 1,911 | | | $ | 1,658 | |
| Other current and non-current liabilities | | 15,590 | | | 9,020 | |
| | $ | 17,501 | | | $ | 10,678 | |
Customers from which we derive more than 10% of our total product revenues for the three and nine months ended September 30, 2026 and 2025 are as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2026 | | 2025 | | 2026 | | 2025 |
AmerisourceBergen Corporation(1) | | 41 | % | | 36 | % | | 40 | % | | 39 | % |
| McKesson | | 35 | % | | 45 | % | | 36 | % | | 40 | % |
| Cardinal Health | | 24 | % | | 19 | % | | 24 | % | | 21 | % |
(1) AmerisourceBergen also operates under the name Cencora.
11.Restructuring, impairment and other related costs
On June 11, 2025, the Board of Directors approved the 2025 Restructuring to focus resources on ZYNLONTA® (loncastuximab tesirine-lpyl) expansion opportunities and the advancement of its PSMA-targeting ADC. The Company has discontinued early development efforts for the remaining preclinical programs in solid tumors. In connection with the 2025 Restructuring, the Company closed down its UK research and development facility, and has reduced its global workforce across functions by approximately 30%. The 2025 Restructuring was complete as of June 30, 2026.
On June 24, 2026, the Company announced a strategic reorganization to focus resources behind key value-driving initiatives in support of ZYNLONTA and has reduced the then-current global workforce by 17% (“2026 Restructuring”). The reduction was driven by the expected completion of the LOTIS-5 and LOTIS-7 trials this year, as well as operational efficiencies. The 2026 Restructuring was complete as of September 30, 2026.
In connection with the 2025 and 2026 Restructurings, the Company reported the following costs in restructuring, impairment and other related costs:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| (in thousands) | 2026 | | 2025 | | 2026 | | 2025 |
| Severance and benefit expense (reversal) | $ | (62) | | | $ | (450) | | | $2,612 | | $6,228 |
| Impairment of long-lived assets and prepaid expenses | — | | | 827 | | | — | | | 7,240 | |
| | | | | | | |
| Total restructuring, impairment and other related costs | $ | (62) | | | $ | 377 | | | $ | 2,612 | | | $ | 13,468 | |
2026 Restructuring
Employees affected by the workforce reduction under the 2026 Restructuring are entitled to receive severance payments, continuing healthcare benefits and other employee-related costs. Costs associated with one-time termination benefits were recorded pursuant to ASC 420, while costs associated with ongoing benefit arrangements were recorded pursuant to ASC 712. As a result, the Company recorded $2.6 million to Restructuring, impairment and other related costs in the Company’s unaudited condensed consolidated statements of operations during the nine months ended September 30, 2026. The 2026 Restructuring was complete as of September 30, 2026.
See Note 17 on the Company’s Annual Report on Form 10‑K for the year ended December 31, 2025 for additional information on the 2025 Restructuring.
12.Other income (expense)
Interest Expense
The components of interest expense for the three and nine months ended September 30, 2026 and 2025 are as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, |
| (in thousands) | | | | | | | | 2026 | | 2025 | | 2026 | | 2025 |
| | | | | | | | | | | | | | |
| Deferred royalty obligation interest expense | | | | | | | | $ | 9,256 | | | $ | 8,996 | | | $ | 27,108 | | | $ | 26,164 | |
| Effective interest expense on senior secured term loan facility | | | | | | | | 4,477 | | | 4,396 | | | 12,482 | | | 12,455 | |
| | | | | | | | | | | | | | |
| Interest expense | | | | | | | | $ | 13,733 | | | $ | 13,392 | | | $ | 39,590 | | | $ | 38,619 | |
Other, net
The components of Other, net for the three and nine months ended September 30, 2026 and 2025 are as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Three Months Ended September 30, | | Nine Months Ended September 30, |
| (in thousands) | | | | 2026 | | 2025 | | 2026 | | 2025 |
| HCR warrant obligation, change in fair value income (expense) | | | | $ | (1,222) | | | $ | — | | | $ | 15,372 | | | $ | — | |
| Cumulative catch-up adjustment, deferred royalty obligation | | | | 2,506 | | | 321 | | | 8,907 | | | 517 | |
| Exchange differences gain (loss) | | | | (123) | | | 338 | | | 90 | | | (599) | |
| R&D tax credit | | | | — | | | 266 | | | (38) | | | 1,028 | |
| Other, net | | | | $ | 1,161 | | | $ | 925 | | | $ | 24,331 | | | $ | 946 | |
13.Share-based compensation
The Company has adopted various share-based compensation incentive plans. Under these plans the Company may at its discretion grant to the plan participants, such as directors, certain employees, and service providers awards in the form of restricted shares and restricted share units (“RSUs”), share options, share appreciation rights, performance awards and other share-based awards. The 2019 Equity Incentive Plan was adopted in November 2019 while the Conditional Share Capital Plan and the Inducement Plan were adopted in December 2023. The amounts of costs recognized for all awards for services received during the three and nine months ended September 30, 2026 were $4,145 and $12,266, with $55 and $200 capitalized to inventory, respectively. For the comparable prior-year periods, costs were $1,999 and $6,482, respectively, with no amounts capitalized to inventory.
2019 Equity Incentive Plan
In November 2019, the Company adopted the 2019 Equity Incentive Plan. Under the 2019 Equity Incentive Plan, the Company may at its discretion grant to plan participants, such as directors, certain employees and service providers, awards in the form of restricted shares and RSUs, share options, share appreciation rights, performance awards and other share-based awards. The Company has reserved 30,291,355 common shares for future issuance under the 2019 Equity Incentive Plan (including share-based equity awards granted to date less awards forfeited). On June 1, 2026, the Company issued 315,000 RSUs under the 2019 Equity Incentive Plan for the 2026 annual non-employee director equity award, which was approved by the Board of Directors. On June 30, 2026 the Company issued 629,205 RSUs under the 2019 Equity Incentive Plan for the one-time retention equity award, which was approved by the Compensation Committee and by the Board of Directors for the senior management team. No share options were issued in connection with either award. As of September 30, 2026, the Company has 9,663,922 common shares available for the future issuance of share-based equity awards.
As of September 30, 2026 and December 31, 2025, the cumulative amount recorded as a net increase to additional paid-in capital within equity on the unaudited condensed consolidated balance sheets in respect of the 2019 Equity Incentive Plan was $175,810 and $165,768, respectively. The amounts of costs recognized for all awards for services received during the three and nine months ended September 30, 2026 were $3,231 and $10,258, respectively, and $1,116 and $3,996 during the three and nine months ended September 30, 2025, respectively.
Conditional Share Capital Plan
In December 2023, the Company adopted the Conditional Share Capital Plan. Under the Conditional Share Capital Plan, the Company may at its discretion grant to plan participants, such as directors, certain employees and service providers, awards in the form of restricted shares and RSUs, share options, share appreciation rights, performance awards and other share-based awards. The Company has reserved 8,000,000 common shares for future issuance under this plan. On February 13, 2026 the Company issued 6,232,465 RSUs under the Conditional Share Capital Plan for the 2026 annual equity award, which was approved by the Compensation Committee and by the Board of Directors for the senior management team. On June 30, 2026 the Company issued 1,926,525 RSUs under the Conditional Share Capital Plan for the one-time retention equity award which was approved by the Compensation Committee and by the Board of Directors for the senior management team. No share options were issued in connection with either award. As of September 30, 2026, the Company has 534,402 common shares available for the future issuance of share-based equity awards.
As of September 30, 2026 and December 31, 2025, the cumulative amount recorded as a net increase to additional paid-in capital within equity on the unaudited condensed consolidated balance sheet in respect of the Conditional Share Capital Plan was $5,416 and $4,267. The amounts of costs for all awards recognized for services received during the three and nine months ended September 30, 2026 were $716 and $1,148, respectively, and $699 and $1,929 during the three and nine months ended September 30, 2025, respectively.
Inducement Plan
In December 2023, the Company adopted the Inducement Plan. Under the Inducement Plan, the Company may at its discretion grant to any employee who is eligible to receive an employment inducement grant in accordance with NYSE Listed Company Manual 303A.08. The maximum number of common shares in respect of which awards may be granted under the Inducement Plan is 2,000,000 common shares (including share-based equity awards granted to date, less awards forfeited), subject to adjustment in the event of certain corporate transactions or events if necessary to prevent dilution or enlargement of the benefits made available under the plan. Equity incentive awards under the Inducement Plan may be granted in the form of options, share appreciation rights, restricted shares, restricted share units, performance awards or other share-based awards but not “incentive stock options” for purposes of U.S. tax laws. As of September 30, 2026, the Company has 833,487 common shares available for the future issuance of share-based equity awards under this plan.
As of September 30, 2026 and December 31, 2025, the cumulative amount recorded as a net increase to additional paid-in capital within equity on the unaudited condensed consolidated balance sheet in respect of the Inducement Plan was $2,110 and $1,332. The amounts of costs for all awards recognized for services received during the three and nine months ended September 30, 2026 were $198 and $779, respectively, and $184 and $557 during the three and nine months ended September 30, 2025, respectively.
Share Options
Pursuant to the 2019 Equity Incentive Plan, the Conditional Share Capital Plan and Inducement Plan (the “Share-based Compensation Plans”), the Company may grant share options to its directors, certain employees and service providers working for the benefit of the Company at the time. The exercise price per share option is set by the Company at the fair market value of the underlying common shares on the date of grant, as determined by the Company, which is generally the closing share price of the Company’s common shares traded on the NYSE. The awards generally vest 25% on the first anniversary of the date of grant, and thereafter evenly on a monthly basis over the subsequent three years. The contractual term of each share option award granted is ten years. Under the grant, the options may be settled only in common shares of the Company. Therefore, the grants of share options under the 2019 Equity Incentive Plan and Inducement Plan have been accounted for as equity-settled under U.S. GAAP. As such, the Company records a charge for the vested portion of award grants and for partially earned but non-vested portions of award grants. This results in a front-loaded charge to the Company’s unaudited condensed consolidated statements of operations and a corresponding increase to additional paid-in capital within equity on the unaudited condensed consolidated balance sheets.
The costs recognized for services received during the three and nine months ended September 30, 2026 were $314 and $1,399, respectively, and $531 and $2,114 during the three and nine months ended September 30, 2025, respectively.
A summary of our stock option award activity for the nine months ended September 30, 2026 is as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Weighted average strike price per share (in $ per share) | | Number of awards | | Weighted average remaining life in years | | Aggregate Intrinsic Value (in $ thousands) |
Outstanding as of December 31, 2025 | | $8.40 | | 10,414,305 | | | 6.77 | | $ | 5,025 | |
| Granted | | 3.87 | | 532,400 | | | | | |
| Forfeited | | 3.19 | | (493,158) | | | | | |
| Expired | | 15.21 | | (543,355) | | | | | |
| Exercised | | 1.90 | | (204,207) | | | | | |
Outstanding as of September 30, 2026 | | $8.17 | | 9,705,985 | | | 6.00 | | $ | 146 | |
Exercisable as of September 30, 2026 | | $9.33 | | 7,845,157 | | | 5.46 | | $ | 103 | |
Awards outstanding as of September 30, 2026 have expiration dates through 2036. The weighted average grant date fair value of the awards granted during the nine months ended September 30, 2026 was $3.12. As of September 30, 2026, the unrecognized compensation cost related to 1,860,828 unvested share options expected to vest was $3.4 million. This unrecognized cost will be recognized over an estimated weighted-average amortization period of 1.66 years.
The exercise price of stock options granted is equal to the closing price of the common stock on the date of grant. The fair values of the options granted under the 2019 Equity Incentive Plan and the Inducement Plan were estimated on the date of the grant using the Black-Scholes option-pricing model. Expected volatility is historical volatility of our common stock. The award life for options granted was based on the time interval between the date of grant and the date during the ten-year life after which, when making the grant, the Company expected on average that participants would exercise their options. The assumptions used were as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2026 | | 2025 | | 2026 | | 2025 |
Expected volatility | | 100% | | 100% | | 100 | % | | 100 | % |
Expected life, (years) | | 6.08 | | 6.08 | | 6.08 | | 6.08 |
Risk-free interest rate | | 4.30-4.30% | | 3.87-3.94% | | 3.73-4.30% | | 3.87-4.43% |
Expected dividend yield | | — | | | — | | | — | | | — | |
RSUs
Pursuant to the Share-based Compensation Plans, the Company may grant RSUs to its directors, certain employees and service providers working for the benefit of the Company at the time. The awards generally vest annually over a period of one to three years commencing on the first anniversary of the date of grant. The RSUs may be settled only in common shares of the Company. Therefore, the grant of RSUs under both the 2019 Equity Incentive Plan and Conditional Share Capital Plan have been accounted for as equity-settled under U.S. GAAP. As such, the Company records a charge for the vested portion of award grants and for partially earned but non-vested portions of award grants. This results in a front-loaded charge to the Company’s unaudited condensed consolidated statements of operations and a corresponding increase to additional paid-in capital within equity on the unaudited condensed consolidated balance sheets. The costs recognized for services received during the three and nine months ended September 30, 2026 were $3,831 and $10,786, respectively, and $1,468 and $4,368 during the three and nine months ended September 30, 2025, respectively. An amount of nil and $985 was withheld for tax withholding obligations during the three and nine months ended September 30, 2026, respectively, and 250 for the three and nine months ended September 30, 2025.
The following table summarizes the RSU awards outstanding as of September 30, 2026:
| | | | | | | | | | | |
| Number of awards | | Weighted average grant date fair value (in $ per share) |
| December 31, 2025 | 4,624,427 | | | $1.74 |
| Granted | 9,103,195 | | | 3.15 |
Vested (1) | (1,764,821) | | | 1.94 |
| Forfeited | (1,452,367) | | | 3.02 |
| September 30, 2026 | 10,510,434 | | | $2.75 |
(1) Includes 262,789 shares withheld to cover tax withholding obligations in connection with the vesting of RSUs previously granted.
The total fair value of RSU awards vested (as measured on the date of vesting) during the nine months ended September 30, 2026 was $6,778.
Employee Stock Purchase Plan
In June 2022, the Company adopted the 2022 Employee Stock Purchase Plan (“ESPP”), which allows eligible employees to purchase designated shares of the Company's common shares at a discount, over a series of offering periods through accumulated payroll deductions. The Company offers the ESPP to employees twice a year with each having a six-month offering period. The first offering period is generally from January 1st through June 30th and the second offering period is from July 1st through December 31st. The grant date is the first day of each offering period.
The costs recognized related to the ESPP during the three and nine months ended September 30, 2026 were nil and $81 respectively, and nil during the three and nine months ended September 30, 2025.
14.Loss per share
The basic loss per share is calculated by dividing the net loss attributable to shareholders by the weighted average number of shares in issue during the period, excluding common shares owned by the Company and held as treasury shares, as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, | | | |
| (in thousands, except share and per share amounts) | | 2026 | | 2025 | | 2026 | | 2025 | | | |
Net loss | | $ | (25,304) | | | $ | (40,966) | | | $ | (74,837) | | | $ | (136,214) | | | | |
Weighted average number of shares outstanding | | 155,410,275 | | | 136,446,534 | | | 154,860,859 | | | 119,237,877 | | | | |
Basic and diluted loss per share | | $ | (0.16) | | | $ | (0.30) | | | $ | (0.48) | | | $ | (1.14) | | | | |
For the three and nine months ended September 30, 2026 and 2025, basic and diluted loss per share are calculated on the weighted average number of shares issued and outstanding, and also considers in the calculation the Company’s outstanding Pre-funded warrants, which were 27,680,776 and 23,897,532 as of September 30, 2026 and 2025, respectively. The calculation excludes shares to be issued under the Share-based Compensation Plans, the Company’s warrants issued in connection with the senior secured term loan facility and the Company’s HCR warrants and shares to be issued under the 2022 ESPP as the effect of including those shares would be anti-dilutive. See Note 6, “Senior secured term loan facility and warrants,” Note 7, “Deferred royalty obligation and warrants” and Note 13, “Share-based compensation,” for further information.
Potentially dilutive securities that were not included in the diluted per share calculations because the effect of including them would be anti-dilutive were as follows:
| | | | | | | | | | | | | | |
| | As of September 30, |
| | 2026 | | 2025 |
| 2019 Equity Incentive Plan - Share Options | | 8,574,543 | | | 9,470,420 | |
| Inducement Plan - Share Options | | 1,131,442 | | | 891,907 | |
| 2019 Equity Incentive Plan - RSUs | | 7,417,240 | | | 2,847,534 | |
| Conditional Share Capital Plan - RSUs | | 3,093,194 | | | 4,169,228 | |
| Outstanding warrants | | 10,362,071 | | | 527,295 | |
| | | | |
| | 30,578,490 | | | 17,906,384 | |
15.Segment reporting
The Company is managed and operated as one reportable segment, which includes all global activities related to the development and commercialization of targeted ADC cancer therapies. The determination of a single reportable segment is consistent with the consolidated financial information regularly provided to the Company’s chief operating decision maker (“CODM”), which is its chief executive officer. The CODM uses loss from operations and consolidated net loss for purposes of assessing performance, making operating decisions, allocating resources and planning and forecasting for future periods. The CODM allocates resources and plans for the long-term growth of the Company based on the Company's available cash resources, forecasted cash flow, and expenditures on a consolidated basis, as well as an assessment of the probability of success of its research and development activities. Resource allocation and long-term growth decisions are informed by budgeted and forecasted expense information, along with actual expenses incurred to date. The measure of segment assets is reported on the consolidated balance sheets as total assets.
The following table is the summary of the segment profit or loss information, including the significant expense categories for the three and nine months ended September 30, 2026 and 2025, respectively:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2026 | | 2025 | | 2026 | | 2025 |
| Total revenues, net | | $ | 21,716 | | | $ | 16,427 | | | $ | 61,815 | | | $ | 58,299 | |
| Significant operating expenses: | | | | | | | | |
Cost of product sales(1) | | (1,785) | | | (1,202) | | | (7,356) | | | (4,099) | |
Research and development(1) | | (13,833) | | | (26,293) | | | (48,786) | | | (83,833) | |
Selling and marketing(1) | | (8,061) | | | (10,345) | | | (31,636) | | | (30,422) | |
General and administrative(1) | | (8,359) | | | (7,180) | | | (24,368) | | | (23,575) | |
| Restructuring and impairment expenses | | 62 | | | (377) | | | (2,612) | | | (13,468) | |
| Share-based compensation | | (4,090) | | | (1,999) | | | (12,066) | | | (6,482) | |
| Total operating expenses | | (36,066) | | | (47,396) | | | (126,824) | | | (161,879) | |
| Loss from operations | | (14,350) | | | (30,969) | | | (65,009) | | | (103,580) | |
Other segment items(2) | | (10,954) | | | (9,997) | | | (9,828) | | | (32,634) | |
| Net loss | | $ | (25,304) | | | $ | (40,966) | | | $ | (74,837) | | | $ | (136,214) | |
(1)Excludes share-based compensation.
(2)Includes Other expense, net, and Income tax expense.
16.Subsequent events
October 2026 Private Placement
On October 7, 2026, the Company entered into securities purchase agreements for the sale of its equity securities to certain institutional investors. In the private placement, the Company sold 12,911,347 common shares at $1.42 per share, and pre-funded warrants (the “October 2026 Pre-Funded Warrants”) to purchase 48,088,653 common shares at $1.32 per pre-funded warrant, which is the price per common share in the private placement minus the exercise price of CHF 0.08 per pre-funded warrant (collectively, the “October 2026 Private Placement”). The private placement
closed on October 22, 2026. Gross proceeds from the October 2026 Private Placement were $82.0 million, and, after giving effect to approximately $5.7 million of transaction costs related to the private placement, net proceeds were approximately $76.3 million.
The October 2026 Pre-Funded Warrants are exercisable, on a cash or cashless basis, at the option of the holder after the date of issuance until the tenth anniversary of their original issuance. At any time during the last 90 days of the term, the holder may exchange the October 2026 Pre-Funded Warrant for, and we will issue, a new pre-funded warrant for the number of common shares then remaining under the October 2026 Pre-Funded Warrant. The October 2026 Pre-Funded Warrants have certain limitations on exercise, including (i) any exercise must be for at least 50,000 common shares (or, if less, the remaining common shares available for purchase under the October 2026 Pre-Funded Warrants), (ii) a holder cannot exercise for any amount that would cause such holder’s beneficial ownership of our common shares to exceed 9.99% (or 19.99% with 61-days’ notice to us), and (iii) cashless exercise is not available in certain circumstances as specified in the October 2026 Pre-Funded Warrants. The warrants contain customary anti-dilution adjustments and will entitle holders to receive any dividends or other distributions paid on the underlying common shares prior to their expiration on an as-exercised basis.
The Company is currently in the process of evaluating the accounting treatment of the October 2026 Private Placement and pre-funded warrants.
Amendment to the Loan Agreement
On October 7, 2026, the Company, certain subsidiaries of the Company, the lenders party thereto and Blue Owl Opportunistic Lending Master Fund I, L.P., as administrative agent and collateral agent, entered into a second amendment (the “Loan Agreement Amendment”) to the Loan Agreement and Guaranty, dated August 15, 2022 (as amended from time to time, the “Loan Agreement”). Following the satisfaction of all closing conditions, including the prepayment of $70.0 million principal amount of term loans under the Loan Agreement (inclusive of the Company’s September 30, 2026 amortization payment plus related accrued interest, fees, and premiums), the Loan Agreement Amendment became effective. Immediately following the prepayment, the remaining principal amount of outstanding term loans was $50.0 million. The Loan Agreement Amendment eliminated subsequent scheduled principal amortization, leaving the remaining principal payable at maturity unless earlier accelerated; eliminated the minimum liquidity covenant; and set the minimum trailing four-quarter U.S. ZYNLONTA sales covenant at $65.0 million for the quarter ending December 31, 2026 and each quarter thereafter.
In connection with the Loan Agreement Amendment, the Company entered into amendments to the Lender Warrants to purchase an aggregate of 527,295 common shares, which were issued on August 15, 2022 in connection with the Loan Agreement. The amendments reduce the exercise price of the Lender Warrants from $8.30 per share to $1.00 per share. The amendments to the Lender Warrants became effective on October 22, 2026, upon the effectiveness of the Loan Agreement Amendment.
The Company is currently in the process of evaluating the accounting treatment for the Loan Agreement Amendment.
Amendment to the Royalty Purchase and Sale Agreement
On October 7, 2026, the Company entered into Amendment No. 2 (the “Second HCR Amendment”) to its Purchase and Sale Agreement, dated August 25, 2021 (as amended from time to time, the “HCR Agreement”), with certain entities managed by Healthcare Royalty Management, LLC (collectively, “HCR”). To date, HCR has provided $300 million of funding to the Company. The Second HCR Amendment eliminates the payment otherwise required solely upon a change of control and permits the Company (or its successor in interest) to exercise its option to buy out the remaining royalty obligations without a change of control by paying HCR $525 million (if the buyout occurs on or prior to December 31, 2029) or $750 million (if the buyout occurs on or after January 1, 2030), less the amount of royalties previously paid to HCR. If this option is not exercised, the royalty obligations under the HCR Agreement will continue until the Royalty Cap (as defined in the HCR Agreement). In addition, the Second HCR Amendment reduces the aggregate outstanding principal amount of third-party indebtedness of the Company and its subsidiaries are permitted to incur to $50.0 million. An uncured breach of this debt limitation covenant entitles HCR to elect to receive the non-performance payment equaling 1.5 times the difference between the $300 million aggregate purchase price and royalty payments and other qualifying credited amounts actually received by HCR, subject to a cure period. The
Second HCR Amendment also requires the Company, subject to shareholder approval and applicable legal and fiduciary duties limitations, to use its best efforts to become a Delaware corporation.
In addition, the Second HCR Amendment amends the HCR Warrants to purchase 9,834,776 common shares, which were issued on February 18, 2026 in connection with the First HCR Amendment, by reducing the exercise price of the HCR Warrants from $3.81 per share to $0.10 per share; by adding a provision that prohibits the exercise of the HCR Warrants if, upon giving effect to such exercise, the aggregate number of the Company’s common shares beneficially owned by the holder (together with its affiliates and certain attribution parties) would exceed 4.99% (or, 61 days after a written notice from such holder, any other percentage not in excess of 9.99%) of the number of the Company’s common shares outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Second HCR Amendment; and removing the contractual restrictions on transfers of the HCR Warrants and shares issuable upon exercise of the HCR Warrants before January 1, 2028. The Second HCR Amendment became effective on October 22, 2026, upon the concurrent completion of the October 2026 Private Placement and the effectiveness of the Loan Agreement Amendment.
The Company is currently in the process of evaluating the accounting treatment for the Second HCR Amendment.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements, including the notes thereto, included in this Quarterly Report, as well as our audited consolidated financial statements, including the notes thereto, included in our Annual Report on Form 10-K. The following discussion includes forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements. See “Forward-Looking Statements.”
Business Overview
ADC Therapeutics is a commercial-stage global pioneer in the field of antibody drug conjugates (“ADCs”), transforming treatment for patients through our focused portfolio with ZYNLONTA ® (loncastuximab tesirine-lpyl), a CD19-directed ADC. ZYNLONTA received accelerated approval from the U.S. Food and Drug Administration (“FDA”), conditional approval from the European Commission, the China National Medical Products Administration (“NMPA”) and Health Canada, as well as approvals in other key global markets for the treatment of relapsed or refractory diffuse large B-cell lymphoma (“DLBCL”) after two or more lines of systemic therapy. Our goal is to be a leading ADC company bringing meaningful therapies to patients in need by leveraging our decade-long experience in the ADC field, with multiple INDs, and a proven track record of success. We are pursuing expansion of ZYNLONTA internationally, and into earlier lines of DLBCL and indolent lymphomas, including marginal zone lymphoma (“MZL”) and follicular lymphoma (“FL”), as a single agent and in combination through our ZYNLONTA clinical program as well as through investigator-initiated trials (“IITs”) at leading institutions.
Recent Organizational and Partner Developments
On June 24, 2026, we announced a strategic reorganization to focus resources behind key value-driving initiatives in support of ZYNLONTA and reduced our global workforce by 17% (“2026 Restructuring”). The reduction was driven by the expected completion of the LOTIS-5 and LOTIS-7 trials this year, as well as operational efficiencies. The 2026 Restructuring was complete as of September 30, 2026. To ensure continuity during this transition, on June 30, 2026, our Board of Directors, with the advice of its independent compensation consultant, approved a one-time retention award to certain of our employees, including our named executive officers.
On October 29, 2026, we announced that our ADC Therapeutics’ Japanese licensing partner, Tanabe Pharma Corporation (formerly Mitsubishi Tanabe Pharma Corporation), has submitted a marketing authorization application with Japan’s Ministry of Health, Labor and Welfare for ZYNLONTA to treat patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. Tanabe Pharma has also entered into an exclusive sublicensing agreement with Nippon Shinyaku Co., Ltd. for the commercialization of ZYNLONTA in Japan.
Clinical Trial Updates
In October 2026 we announced new and updated data from the ZYNLONTA clinical program which will be shared across multiple abstracts, including five oral presentations, at the 68th American Society of Hematology (“ASH”) Annual Meeting taking place December 12–15, 2026, in New Orleans, Louisiana.
Across the presentations, the data provide additional insight into the depth and durability of response observed with ZYNLONTA across multiple B-cell lymphomas and treatment settings, including in difficult-to-treat patient populations. Oral presentations include expanded LOTIS-7 data evaluating ZYNLONTA in combination with glofitamab in r/r DLBCL and updated data evaluating ZYNLONTA in r/r MZL, as well as full results from the Phase 3 LOTIS-5r/r DLBCL study and data from investigator-initiated trials in r/r mantle cell lymphoma (“MCL”) and r/r Waldenström macroglobulinemia (“WM”).
LOTIS-7 Phase 1b study: ZYNLONTA plus glofitamab in relapsed or refractory DLBCL
Updated results from LOTIS-7 continue to demonstrate encouraging efficacy and safety findings with ZYNLONTA plus glofitamab, including in difficult-to-treat patient populations.
As of the data cutoff of as of June 15, 2026, at the ZYNLONTA 150 µg/kg starting dose + glofitamab:
•Among 97 efficacy-evaluable patients, the overall response rate (“ORR”) was 88.7%, and the complete response rate (“CRR”) was 75.3%.
•Patients had received a median of one prior treatment (range 1-5); 52.4% were primary refractory.
•In patients with primary refractory disease, ORR was 78.4% and CRR was 64.7%. Among patients previously treated with prior CAR-T therapy, ORR was 74.1% and CRR was 63.0%.
•At a median follow-up of 10.35 months, median duration of response, duration of complete response and progression-free survival (“PFS”) had not been reached. The 12-month duration of complete response rate was 79.0%.
•In an exploratory MRD analysis of 12 patients who achieved a complete response, 50% achieved undetectable MRD as early as Cycle 2, Day 1, and 11 had undetectable MRD at end of treatment.
•Cytokine release syndrome (“CRS”) occurred in 32% of treated patients, predominantly Grade 1 (25.2%) or 2 (5.8%). One Grade 3 CRS event was reported, and no Grade 3 or higher ICANS events occurred. Three Grade 5 treatment-emergent adverse events were reported.
Phase 2 IIT: Fixed-duration ZYNLONTA in relapsed or refractory marginal zone lymphoma
An investigator-led, multicenter Phase 2 study demonstrated high response rates and encouraging durability with fixed-duration ZYNLONTA in patients with relapsed or refractory MZL.
As of the July 1, 2026 data cutoff:
•Among 43 efficacy-evaluable patients, ORR was 93% and CRR was 74.4%.
•Patients had received a median of two prior treatments; 37% had primary refractory disease and 42% had experienced disease progression within 24 months of initial therapy.
•At a median follow-up of 23.2 months, the two-year PFS rate was 90.8%.
•The duration of response rate at 24 months was 90.9%.
•Among 46 treated patients, adverse events (“AEs”) were predominantly Grade 1–2. Grade 3 AEs (36 events) were reported in 23 patients (50%), and Grade 4 AEs (5 events) in five patients (10.9%). The most common Grade 3 events included anemia (n=5), lung infections (n=5), elevated ALT (n=4), alkaline phosphatase (n=3) and AST (n=1). Grade 4 events included neutropenia (n=2), thrombocytopenia (n=2) and hyponatremia (n=1). Four patients required dose reductions.
Phase 3 LOTIS-5 study: ZYNLONTA plus rituximab versus R-GemOx in relapsed or refractory DLBCL
Full results from the randomized Phase 3 LOTIS-5 study of 420 patients demonstrated a statistically significant improvement in the primary endpoint of PFS with ZYNLONTA plus rituximab compared with R-GemOx.
As of the data cutoff of February 16, 2026:
•Median PFS by independent review was 6.14 months with ZYNLONTA plus rituximab versus 4.73 months with R-GemOx (HR 0.73; 95% CI, 0.57–0.92; P=0.0083).
•ORR was 58.1% versus 45.2%, and CRR was 39.5% versus 26.7%, respectively.
•Median duration of complete response was 16.82 months versus 12.25 months. At 24 months, 48.5% versus 16.7% of patients who achieved a complete response remained in complete response.
•No statistically significant difference in overall survival was observed between treatment arms.
•Within the protocol-defined 105-day treatment-emergent adverse event reporting window, Grade 3 or higher events occurred in 74.0% versus 76.1% of patients, and Grade 5 events occurred in 13.2% versus 4.6%, respectively. Using a standard 30-day post-treatment window, Grade 5 events occurred in 1.5% versus 3.0%, respectively.
Results of Operations
Three Months Ended September 30, 2026 Compared to Three Months Ended September 30, 2025
The following table summarizes our results of operations for the three months ended September 30, 2026 and 2025:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, |
| (in thousands, except percentages and per share) | 2026 | | 2025 | | Change | | % Change |
| Revenue | | | | | | | |
| Product revenues, net | $ | 21,006 | | | $ | 15,750 | | | $ | 5,256 | | | 33.4 | % |
| License revenues and royalties | 710 | | | 677 | | | 33 | | | 4.9 | % |
| Total revenue, net | 21,716 | | | 16,427 | | | 5,289 | | | 32.2 | % |
| | | | | | | |
| Operating expense | | | | | | | |
| Cost of product sales | (1,980) | | | (1,202) | | | (778) | | | 64.7 | % |
| Research and development | (14,738) | | | (26,803) | | | 12,065 | | | (45.0) | % |
| Selling and marketing | (8,674) | | | (10,688) | | | 2,014 | | | (18.8) | % |
| General and administrative | (10,736) | | | (8,326) | | | (2,410) | | | 28.9 | % |
| Restructuring, impairment and other related costs | 62 | | | (377) | | | 439 | | | (116.4) | % |
| Total operating expense | (36,066) | | | (47,396) | | | 11,330 | | | (23.9) | % |
| Loss from operations | (14,350) | | | (30,969) | | | 16,619 | | | (53.7) | % |
| | | | | | | |
| Other income (expense) | | | | | | | |
| Interest income | 1,618 | | | 2,470 | | | (852) | | | (34.5) | % |
| Interest expense | (13,733) | | | (13,392) | | | (341) | | | 2.5 | % |
| Other, net | 1,161 | | | 925 | | | 236 | | | 25.5 | % |
| Total other expense, net | (10,954) | | | (9,997) | | | (957) | | | 9.6 | % |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| Net loss | $ | (25,304) | | | $ | (40,966) | | | $ | 15,662 | | | (38.2) | % |
| | | | | | | |
| | | | | | | |
| Net loss per share, basic and diluted | $ | (0.16) | | | $ | (0.30) | | | $ | 0.14 | | | (46.7) | % |
Revenue
Product Revenues, net
We generate product revenue through the sale of ZYNLONTA in the United States. Revenue is recognized when control is transferred to the customer at the net selling price, which includes reductions for gross-to-net (“GTN”) sales adjustments such as government rebates, chargebacks, distributor service fees, other rebates and administrative fees, sales returns and allowances and sales discounts. Our product revenue may fluctuate from period to period based on a number of factors, including patient demand, as well as the timing, dose and duration of patient therapy and customers’ ordering patterns, pricing and GTN deductions. We expect a relatively consistent level of GTN sales adjustments as a percentage of gross sales, but may also experience variability in GTN sales adjustments due to additional information and actual experience such as actual rebate and return rates.
Product revenues, net, were $21.0 million for the three months ended September 30, 2026 as compared to $15.8 million for the three months ended September 30, 2025, an increase of $5.3 million, or 33.4%. The increase is primarily attributable to higher sales volume.
License Revenues and Royalties
We generate license revenue and royalties from our strategic agreements for the development and commercialization of ZYNLONTA outside of the United States. Under these agreements, we receive upfront payments and are eligible for certain milestone payments and royalties. See “Item 1. Business—Material Contracts” in our Annual Report on Form 10-K.
We are unable to predict the timing and amounts of license revenue and royalties as meeting milestones is subject to many factors outside of our control and we have limited control over our partners’ commercialization efforts.
License revenues and royalties were $0.7 million for the three months ended September 30, 2026 and 2025, respectively.
Operating Expenses
Cost of Product Sales
Cost of product sales includes costs directly and indirectly relating to the manufacture of ZYNLONTA commercial drug substance and drug product, including the third-party manufacture costs of our contract manufacturing organizations (“CMOs”), as well as internal personnel costs, including share-based compensation, associated with the production of ZYNLONTA. Cost of product sales also includes royalties payable to a collaboration partner based on net product sales of ZYNLONTA, idle capacity costs, and inventory write-downs for changes in reserves for excess inventory or write-offs of inventory that fail to meet specification. We expect that cost of product sales will continue to increase over time as we sell through pre-approval inventory that was previously expensed prior to commercialization under U.S. GAAP. Factors such as inflation, tariffs and other external factors may also increase our cost of product sales.
Cost of product sales were $2.0 million for the three months ended September 30, 2026 as compared to cost of product sales of $1.2 million for the three months ended September 30, 2025, an increase of $0.8 million, or 64.7%. The increase in cost of product sales was primarily attributable to a $1.2 million increase in certain personnel costs, reflecting a change in focus of these personnel from research and development clinical supply activities to commercial manufacturing activities, partially offset by a $0.4 million credit recognized in connection with final price negotiations with a vendor for a failed production batch from the first quarter of 2026.
Research and Development Expenses
The following table summarizes our research and development expenses for the three months ended September 30, 2026 and 2025:
| | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, |
| (in thousands) | 2026 | | 2025 | | Change |
| External costs and overhead | $ | 4,972 | | | $ | 15,023 | | | $ | (10,051) | |
Employee expenses(1) | 8,861 | | | 11,270 | | | (2,409) | |
| Share-based compensation expense | 905 | | | 510 | | | 395 | |
| Research and development expenses | $ | 14,738 | | | $ | 26,803 | | | $ | (12,065) | |
(1) Excludes share-based compensation expense.
Research and development expense consists primarily of costs for production of preclinical and clinical-stage product candidates by CMOs; fees and other costs paid to contract research organizations in connection with the performance of preclinical studies and clinical trials; costs of related facilities, materials and equipment; external costs associated with obtaining intellectual property; depreciation; upfront fees and achieved milestone payments associated with R&D collaboration arrangements; and employee related expenses, including share-based compensation expense.
We expect our research and development expense to decrease for fiscal year 2026, as compared to 2025, primarily driven by an expected reduction in spending on discontinued programs and our preclinical product candidates and research pipeline as a result of the 2025 and 2026 Restructurings, as well as reduced spend on ZYNLONTA due to the timing, progress and stage of clinical trials. Thereafter, our research and development expense may fluctuate from period to period based on a number of factors, including the timing, progress and stage of clinical trials, costs associated with regulatory approval processes and manufacturing costs associated with commercialization activities prior to the receipt of regulatory approval.
Our R&D expenses were $14.7 million for the three months ended September 30, 2026 as compared to $26.8 million for the three months ended September 30, 2025, a decrease of $12.1 million, or 45.0%.
The decrease in external costs and overhead of $10.1 million was driven primarily by discontinued programs and our preclinical product candidates and research pipeline as a result of the 2025 Restructuring, completion of IND-enabling activities for our PSMA-targeting ADC, as well as a decrease in ZYNLONTA spend due to the timing and enrollment of our ZYNLONTA clinical trials and related costs incurred in connection with the LOTIS-5 and LOTIS-7 trials.
The changes in employee and share-based compensation expenses were primarily driven by lower wages and benefits of $2.8 million resulting from the 2025 Restructuring and the 2026 Restructuring. This decrease was partially offset by higher cash-based retention awards of $1.4 million and $0.7 million in higher temporary project help. Additionally, we had a $1.7 million shift in personnel costs (including $0.3 million in share-based compensation expense) to cost of product sales ($1.0 million), inventory capitalization ($0.5 million) and selling and marketing expense ($0.2 million), reflecting a change in focus of these personnel from research and development activities to commercial manufacturing and fulfillment activities. These decreases were partially offset by higher share-based compensation expense for one-time RSU retention awards granted during the year and higher grant date fair values for annual RSU awards.
Selling and Marketing Expenses
The following table summarizes our selling and marketing expenses for the three months ended September 30, 2026 and 2025:
| | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, |
| (in thousands) | 2026 | | 2025 | | Change |
| External costs and overhead | $ | 2,535 | | | $ | 4,999 | | | $ | (2,464) | |
Employee expenses(1) | 5,526 | | | 5,346 | | | 180 | |
| Share-based compensation expense | 613 | | | 343 | | | 270 | |
| Selling and marketing expenses | $ | 8,674 | | | $ | 10,688 | | | $ | (2,014) | |
(1) Excludes share-based compensation expense.
Selling and marketing costs (“S&M”) are expensed as incurred and are primarily attributable to commercialization of ZYNLONTA in the United States. S&M includes employee costs and share-based compensation expense for commercial employees and external costs related to commercialization (including professional fees, communication costs and IT costs, travel expenses and depreciation of property and equipment).
Selling and marketing expenses were $8.7 million for the three months ended September 30, 2026 as compared to $10.7 million for the three months ended September 30, 2025, a decrease of $2.0 million, or 18.8%. The decrease in external costs and overhead of $2.5 million was primarily attributable to lower spend on marketing and advertising expenses. The increase in employee and share-based compensation expenses were due to a $0.2 million increase in certain personnel costs, reflecting an increase in commercial fulfillment activities. The increase in employee expenses reflects $0.6 million in higher cash-based retention and incentive awards, offset by $0.5 million in lower wages and benefits. The increase in share-based compensation expense was also driven by RSU retention awards granted during the year and higher grant date fair values for annual RSU awards.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the three months ended September 30, 2026 and 2025:
| | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, |
| (in thousands) | 2026 | | 2025 | | Change |
| External costs and overhead | $ | 3,366 | | | $ | 3,112 | | | $ | 254 | |
Employee expenses(1) | 4,993 | | | 4,067 | | | 926 | |
| Share-based compensation expense | 2,377 | | | 1,147 | | | 1,230 | |
| General and administrative expenses | $ | 10,736 | | | $ | 8,326 | | | $ | 2,410 | |
(1) Excludes share-based compensation expense.
General and administrative expense includes employee related costs (including wages, benefits and share-based compensation expense) for general and administrative employees, external costs (including, in particular, professional fees, legal fees and costs associated with maintaining patents and other intellectual property, communications costs and IT costs, facility expenses and travel expenses) and depreciation of property and equipment and right-of-use assets.
General and administrative expenses were $10.7 million for the three months ended September 30, 2026 as compared to $8.3 million for the three months ended September 30, 2025, an increase of $2.4 million, or 28.9%. The increase in external costs and overhead of $0.3 million was primarily related to higher legal expenses. The increase in employee expenses of $0.9 million was primarily driven by higher cash-based retention awards. The increase in share-based
compensation expense of $1.2 million was primarily driven by RSU retention awards granted during the year and higher grant date fair values for annual RSU awards.
Restructuring, Impairment and Other Related Costs
In connection with the 2026 Restructuring, we incurred a reversal to Restructuring, impairment, and other related costs of $0.1 million for the three months ended September 30, 2026, which related to adjustments in the severance and related benefit cost estimates previously recognized. The 2026 Restructuring was complete as of September 30, 2026. In connection with the 2025 Restructuring, we incurred Restructuring, impairment, and other related costs of $0.4 million for the three months ended September 30, 2025, which consisted of $0.8 million for the estimated fair value of retirement costs associated with the U.K. lease agreements, partially offset by $0.5 million in adjustments related to severance and related benefit costs. The 2025 Restructuring was complete as of June 30, 2026.
Other Income (Expense)
Interest Income
Interest income was $1.6 million for the three months ended September 30, 2026 as compared to $2.5 million for the three months ended September 30, 2025, a decrease of $0.9 million, or 34.5%. The decrease was primarily due to our lower average cash balances.
Interest Expense
Interest expense is primarily related to the accretion of our deferred royalty obligation with HCR and the senior secured term loan facility. Interest expense was $13.7 million for the three months ended September 30, 2026 as compared to $13.4 million for the three months ended September 30, 2025, an increase of $0.3 million, or 2.5%. The increase was primarily related to higher accretion of our deferred royalty obligation with HCR as a result of higher total revenue, net, as well as a higher effective interest rate as a result of the HCR Amendment.
Other, net
Other, net consists primarily of the change in the fair value of the HCR warrant obligation, cumulative catch-up adjustments related to our deferred royalty obligation and the R&D tax credit from our UK operations. Other, net as of September 30, 2026 and 2025 included the following:
| | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, |
| (in thousands) | 2026 | | 2025 | | Change |
| | | | | |
| HCR warrant obligation, change in fair value expense | $ | (1,222) | | | $ | — | | | $ | (1,222) | |
| Cumulative catch-up adjustment income, deferred royalty obligation | 2,506 | | | 321 | | | 2,185 | |
| Exchange differences gain (loss) | (123) | | | 338 | | | (461) | |
| R&D tax credit gain (loss) | — | | | 266 | | | (266) | |
| Total | $ | 1,161 | | | $ | 925 | | | $ | 236 | |
HCR Warrants
On February 18, 2026, we entered into an amendment (the “First HCR Amendment”) to the Purchase and Sale Agreement, dated August 25, 2021. In connection with the First HCR Amendment, the Company issued to HCR warrants to purchase 9,834,776 common shares. The HCR warrant obligation has been recorded at its initial fair value at the time the agreement was entered into on February 18, 2026 and is remeasured to fair value at the end of each reporting period. The fair value of the warrant obligation as of September 30, 2026 was $5.4 million. The expense of $1.2 million for the three months ended September 30, 2026 was primarily due to the increase in fair value of the underlying shares during the respective period.
Cumulative catch-up adjustment income, deferred royalty obligation
We periodically assess the expected payments to HCR based on our underlying revenue projections and to the extent the amount or timing of such payments is materially different than our initial estimates we will record a cumulative catch-up adjustment to the deferred royalty obligation. The adjustment to the carrying amount is recognized in Other, net as an adjustment in the period in which the change in estimate occurred. The cumulative catch-up adjustment income was $2.5 million for the three months ended September 30, 2026 as compared to $0.3 million for the three months ended September 30, 2025, a change of $2.2 million. The change was primarily due to revised revenue forecasts incorporated into
the valuation model in 2026, as a result of changes in assumptions in the Company’s updated strategic and development plans.
Nine Months Ended September 30, 2026 Compared to Nine Months Ended September 30, 2025
The following table summarizes our results of operations for the nine months ended September 30, 2026 and 2025:
| | | | | | | | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, |
| (in thousands, except percentages and per share) | 2026 | | 2025 | | Change | | % Change |
| Revenue | | | | | | | |
| Product revenues, net | $ | 59,673 | | | $ | 51,239 | | | $ | 8,434 | | | 16.5 | % |
| License revenues and royalties | 2,142 | | | 7,060 | | | (4,918) | | | (69.7) | % |
| Total revenue, net | 61,815 | | | 58,299 | | | 3,516 | | | 6.0 | % |
| | | | | | | |
| Operating expense | | | | | | | |
| Cost of product sales | (7,944) | | | (4,099) | | | (3,845) | | | 93.8 | % |
| Research and development | (51,981) | | | (85,821) | | | 33,840 | | | (39.4) | % |
| Selling and marketing | (33,954) | | | (31,388) | | | (2,566) | | | 8.2 | % |
| General and administrative | (30,333) | | | (27,103) | | | (3,230) | | | 11.9 | % |
| Restructuring, impairment and other related costs | (2,612) | | | (13,468) | | | 10,856 | | | (80.6) | % |
| Total operating expense | (126,824) | | | (161,879) | | | 35,055 | | | (21.7) | % |
| Loss from operations | (65,009) | | | (103,580) | | | 38,571 | | | (37.2) | % |
| | | | | | | |
| Other income (expense) | | | | | | | |
| Interest income | 5,431 | | | 6,458 | | | (1,027) | | | (15.9) | % |
| Interest expense | (39,590) | | | (38,619) | | | (971) | | | 2.5 | % |
| Other, net | 24,331 | | | 946 | | | 23,385 | | | 2472.0 | % |
| Total other expense, net | (9,828) | | | (31,215) | | | 21,387 | | | (68.5) | % |
| | | | | | | |
| Loss before income taxes | (74,837) | | | (134,795) | | | 59,958 | | | (44.5) | % |
| Income tax expense | — | | | (1,419) | | | 1,419 | | | (100.0) | % |
| Net loss | (74,837) | | | (136,214) | | | 61,377 | | | (45.1) | % |
| | | | | | | |
| | | | | | | |
| Net loss per share, basic and diluted | $ | (0.48) | | | $ | (1.14) | | | $ | 0.66 | | | (57.9) | % |
Revenue
Product Revenues, net
We generate product revenue through the sale of ZYNLONTA in the United States. Revenue is recognized when control is transferred to the customer at the net selling price, which includes reductions for gross-to-net (“GTN”) sales adjustments such as government rebates, chargebacks, distributor service fees, other rebates and administrative fees, sales returns and allowances and sales discounts. Our product revenue may fluctuate from period to period based on a number of factors, including patient demand, as well as the timing, dose and duration of patient therapy and customers’ ordering patterns, pricing and GTN deductions. We expect a relatively consistent level of GTN sales adjustments as a percentage of gross sales, but may also experience variability in GTN sales adjustments due to additional information and actual experience such as actual rebate and return rates.
Product revenues, net, were $59.7 million for the nine months ended September 30, 2026 as compared to $51.2 million for the nine months ended September 30, 2025, an increase of $8.4 million, or 16.5%. The increase is primarily attributable to higher sales volume.
License Revenues and Royalties
We generate license revenue and royalties from our strategic agreements for the development and commercialization of ZYNLONTA outside of the United States. Under these agreements, we receive upfront payments and are eligible for certain milestone payments and royalties. See “Item 1. Business—Material Contracts” in our Annual Report on Form 10-K.
We are unable to predict the timing and amounts of license revenue and royalties as meeting milestones is subject to many factors outside of our control and we have limited control over our partners’ commercialization efforts.
License revenues and royalties were $2.1 million for the nine months ended September 30, 2026 as compared to $7.1 million for the nine months ended September 30, 2025. The decrease was driven by a one-time $5.0 million milestone recognized during the prior year. We received the $5.0 million milestone in connection with the conditional approval by Health Canada for the treatment of relapsed or refractory DLBCL after two or more lines of systemic therapy under our exclusive license agreement with Sobi.
Operating Expenses
Cost of Product Sales
Cost of product sales includes costs directly and indirectly relating to the manufacture of ZYNLONTA commercial drug substance and drug product, including the third-party manufacture costs of our contract manufacturing organizations (“CMOs”), as well as internal personnel costs, including share-based compensation, associated with the production of ZYNLONTA. Cost of product sales also includes royalties payable to a collaboration partner based on net product sales of ZYNLONTA, idle capacity costs, and inventory write-downs for changes in reserves for excess inventory or write-offs of inventory that fail to meet specification. We expect that cost of product sales will continue to increase over time as we sell through pre-approval inventory that was previously expensed prior to commercialization under U.S. GAAP. Factors such as inflation, tariffs and other external factors may also increase our cost of product sales.
Cost of product sales were $7.9 million for the nine months ended September 30, 2026 as compared to cost of product sales of $4.1 million for the nine months ended September 30, 2025, an increase of $3.8 million, or 93.8%. The increase in cost of product sales was primarily attributable to a $3.7 million increase in certain personnel costs, reflecting a change in focus of these personnel from research and development clinical supply activities to commercial manufacturing activities, as well as higher stability, shipping and storage charges of $0.6 million, partially offset by a $0.4 million credit recognized in connection with final price negotiations with a vendor for a failed production batch from the first quarter of 2026.
Research and Development Expenses
The following table summarizes our research and development expenses for the nine months ended September 30, 2026 and 2025:
| | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, |
| (in thousands) | 2026 | | 2025 | | Change |
| External costs and overhead | $ | 21,719 | | | $ | 48,073 | | | $ | (26,354) | |
Employee expenses(1) | 27,067 | | | 35,760 | | | (8,693) | |
| Share-based compensation expense | 3,195 | | | 1,988 | | | 1,207 | |
| Research and development expenses | $ | 51,981 | | | $ | 85,821 | | | $ | (33,840) | |
(1) Excludes share-based compensation expense.
Research and development expense consists primarily of costs for production of preclinical and clinical-stage product candidates by CMOs; fees and other costs paid to contract research organizations in connection with the performance of preclinical studies and clinical trials; costs of related facilities, materials and equipment; external costs associated with obtaining intellectual property; depreciation; upfront fees and achieved milestone payments associated with R&D collaboration arrangements; and employee related expenses, including share-based compensation expense.
We expect our research and development expense to decrease for fiscal year 2026, as compared to 2025, primarily driven by an expected reduction in spending on discontinued programs and our preclinical product candidates and research pipeline as a result of the 2026 Restructuring and the 2025 Restructuring, as well as reduced spend on ZYNLONTA due to the timing, progress and stage of clinical trials. Thereafter, our research and development expense may fluctuate from period to period based on a number of factors, including the timing, progress and stage of clinical trials, costs associated with regulatory approval processes and manufacturing costs associated with commercialization activities prior to the receipt of regulatory approval.
Our R&D expenses were $52.0 million for the nine months ended September 30, 2026 as compared to $85.8 million for the nine months ended September 30, 2025, a decrease of $33.8 million, or 39.4%.
The decrease in external costs and overhead of $26.4 million was driven primarily by discontinued programs and our preclinical product candidates and research pipeline as a result of the 2025 Restructuring, completion of IND-enabling
activities for our PSMA-targeting ADC, as well as a decrease in ZYNLONTA spend due to the timing and enrollment of our ZYNLONTA clinical trials and related costs incurred in connection with the LOTIS-5 and LOTIS-7 trials
The changes in employee and share-based compensation expenses were primarily driven by lower wages and benefits of $7.4 million resulting from the 2025 Restructuring and the 2026 Restructuring. This decrease was partially offset by higher cash-based retention awards of $1.3 million and $2.7 million in higher temporary project help. Additionally, we had a $5.5 million shift in personnel costs (including $0.7 million in share-based compensation expense) to cost of product sales ($3.3 million), inventory capitalization ($1.6 million) and selling and marketing expense ($0.6 million), reflecting a change in focus of these personnel from research and development activities to commercial manufacturing and fulfillment activities. These decreases were partially offset by higher share-based compensation expense for RSU retention awards granted during the year and higher grant date fair values for annual RSU awards.
Selling and Marketing Expenses
The following table summarizes our selling and marketing expenses for the nine months ended September 30, 2026 and 2025:
| | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, |
| (in thousands) | 2026 | | 2025 | | Change |
| External costs and overhead | $ | 13,541 | | | $ | 13,631 | | | $ | (90) | |
Employee expenses(1) | 18,095 | | | 16,791 | | | 1,304 | |
| Share-based compensation expense | 2,318 | | | 966 | | | 1,352 | |
| Selling and marketing expenses | $ | 33,954 | | | $ | 31,388 | | | $ | 2,566 | |
(1) Excludes share-based compensation expense.
Selling and marketing costs (“S&M”) are expensed as incurred and are primarily attributable to commercialization of ZYNLONTA in the United States. S&M includes employee costs and share-based compensation expense for commercial employees and external costs related to commercialization (including professional fees, communication costs and IT costs, travel expenses and depreciation of property and equipment).
Selling and marketing expenses were $34.0 million for the nine months ended September 30, 2026 as compared to $31.4 million for the nine months ended September 30, 2025, an increase of $2.6 million, or 8.2%. The increase in employee and share-based compensation expenses were primarily due to $0.8 million in higher cash-based retention and incentive awards and a $0.6 million increase in certain personnel costs, reflecting an increase in commercial fulfillment activities. The increase in share-based compensation expense was also driven by RSU retention awards granted during the year and higher grant date fair values for annual RSU awards.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the nine months ended September 30, 2026 and 2025:
| | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, |
| (in thousands) | 2026 | | 2025 | | Change |
| External costs and overhead | $ | 11,585 | | | $ | 9,943 | | | $ | 1,642 | |
Employee expenses(1) | 12,783 | | | 13,632 | | | (849) | |
| Share-based compensation expense | 5,965 | | | 3,528 | | | 2,437 | |
| General and administrative expenses | $ | 30,333 | | | $ | 27,103 | | | $ | 3,230 | |
(1) Excludes share-based compensation expense.
General and administrative expense includes employee related costs (including wages, benefits and share-based compensation expense) for general and administrative employees, external costs (including, in particular, professional fees, legal fees and costs associated with maintaining patents and other intellectual property, communications costs and IT costs, facility expenses and travel expenses) and depreciation of property and equipment and right-of-use assets.
General and administrative expenses were $30.3 million for the nine months ended September 30, 2026 as compared to $27.1 million for the nine months ended September 30, 2025, an increase of $3.2 million, or 11.9%. The increase in external costs and overhead of $1.6 million was primarily related to $0.6 million in higher legal expenses, higher IT expenses of $0.6 million and a one-time VAT recovery of $0.5 million recognized in the prior year. The decrease in
employee expenses of $0.8 million was primarily due to lower wages and benefits of $1.2 million and lower temporary project help of $0.3 million, partially offset by $0.7 million in higher cash-based retention awards. The increase in share-based compensation expense of $2.4 million was primarily due to RSU retention awards granted during the year and higher grant date fair values for annual RSU awards.
Restructuring, Impairment and Other Related Costs
In connection with the 2026 Restructuring, we incurred Restructuring, impairment, and other related costs of $2.6 million for the nine months ended September 30, 2026, which consisted of severance and related benefit costs. The 2026 Restructuring was complete as of September 30, 2026. In connection with the 2025 Restructuring, we incurred Restructuring, impairment, and other related costs of $13.5 million for the nine months ended September 30, 2025, which consisted of $6.2 million in severance and related benefit costs, $6.4 million in impairment of long-lived assets and prepaid expenses, and $0.8 million for the estimated fair value of retirement costs associated with the U.K. lease agreement. The 2025 Restructuring was complete as of June 30, 2026.
Other Income (Expense)
Interest Income
Interest income was $5.4 million for the nine months ended September 30, 2026 as compared to $6.5 million for the nine months ended September 30, 2025, a decrease of $1.0 million or 15.9%. The decrease was primarily due to our lower average cash balances.
Interest Expense
Interest expense is primarily related to the accretion of our deferred royalty obligation with HCR and the senior secured term loan facility. Interest expense was $39.6 million for the nine months ended September 30, 2026 as compared to $38.6 million for the nine months ended September 30, 2025, an increase of $1.0 million, or 2.5%. The increase was primarily related to higher accretion of our deferred royalty obligation with HCR as a result of higher total revenue, net, as well as a higher effective interest rate as a result of the First HCR Amendment.
Other, net
Other, net consists primarily of the change in the fair value of the HCR warrant obligation, cumulative catch-up adjustments related to our deferred royalty obligation and the R&D tax credit from our UK operations. Other, net as of September 30, 2026 and 2025 included the following:
| | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, |
| (in thousands) | 2026 | | 2025 | | Change |
| | | | | |
| HCR warrant obligation, change in fair value income | $ | 15,372 | | | $ | — | | | $ | 15,372 | |
| Cumulative catch-up adjustment, deferred royalty obligation | 8,907 | | | 517 | | | 8,390 | |
| Exchange differences gain (loss) | 90 | | | (599) | | | 689 | |
| R&D tax credit gain (loss) | (38) | | | 1,028 | | | (1,066) | |
| Total | $ | 24,331 | | | $ | 946 | | | $ | 23,385 | |
HCR Warrants
On February 18, 2026, we entered into the First HCR Amendment. In connection with the First HCR Amendment, the Company issued to HCR warrants to purchase 9,834,776 common shares. The HCR warrant obligation has been recorded at its initial fair value at the time the agreement was entered into on February 18, 2026 and is remeasured to fair value at the end of each reporting period. The fair value of the warrant obligation as of September 30, 2026 was $5.4 million. The income of $15.4 million for the nine months ended September 30, 2026 was primarily due to the decrease in fair value of the underlying shares during the respective period.
Cumulative catch-up adjustment income, deferred royalty obligation
We periodically assess the expected payments to HCR based on our underlying revenue projections and to the extent the amount or timing of such payments is materially different than our initial estimates we will record a cumulative catch-up adjustment to the deferred royalty obligation. The adjustment to the carrying amount is recognized in Other, net as an adjustment in the period in which the change in estimate occurred. The cumulative catch-up adjustment income was $8.9 million for the nine months ended September 30, 2026 as compared to $0.5 million for the nine months ended September 30, 2025, a change of $8.4 million. The change was primarily due to revised revenue forecasts incorporated into
the valuation model in 2026, as a result of changes in assumptions in the Company’s updated strategic and development plans.
Income Tax Expense
We are subject to corporate taxation in Switzerland and in other jurisdictions in which we operate, including the United States and the United Kingdom, where our two wholly-owned subsidiaries are incorporated. Under Swiss law, we are permitted to carry forward net operating losses for up to seven years, which may be used to offset future taxable income. Under U.S. tax law, research and development tax credits may generally be carried forward for up to 20 years and used to offset future tax liabilities, subject to statutory requirements. We recorded an income tax expense of nil for the nine months ended September 30, 2026 as compared to $1.4 million for the nine months ended September 30, 2025, primarily driven by a tax adjustment in our UK operations recorded in the comparable prior period as a result of the 2025 Restructuring.
Liquidity and Capital Resources
As of September 30, 2026, we had cash and cash equivalents of $189.2 million and believe that our current cash position and capital resources are sufficient to fund our operation and meet capital requirements for at least the next twelve months from the date of this report.
Subsequent to the end of the period, in October 2026, we restructured our liquidity profile, equity capital structure and outstanding debt obligations through a series of coordinated strategic transactions.
We plan to continue to fund our operating needs through our existing cash and cash equivalents, revenues from sales of ZYNLONTA, potential milestone and royalty payments under our licensing agreements and additional equity financings, debt financings and/or other forms of financing, as well as potential funds provided by collaborations. We are continuously exploring a broad range of value maximizing alternatives, including strategic collaborations, business combinations, licensing opportunities, financing and refinancing opportunities and other strategies. However, we may be unable to identify or execute on such opportunities on favorable terms, if at all.
Sources of Liquidity and Capital Resources
To date, we have financed our operations primarily through equity financings, convertible debt and senior secured term loan financings, and additional funds provided by collaborations and royalty financings and sales of ZYNLONTA in the United States.
On October 22, 2026, we sold 12,911,347 common shares at $1.42 per share, and pre-funded warrants (the “October 2026 Pre-Funded Warrants”) to purchase 48,088,653 common shares at $1.32 per pre-funded warrant, which is the price per common share in the private placement minus the exercise price of CHF 0.08 per pre-funded warrant to certain institutional investors (collectively, the “October 2026 Private Placement”), resulting in net proceeds of $76.3 million.
In addition, on October 22, 2026, we prepaid $70.0 million of outstanding term loans under the Loan Agreement (inclusive of the Company’s September 30, 2026 amortization payment, plus related accrued interest, fees, and premiums) and an amendment to the Loan Agreement became effective which eliminated subsequent scheduled principal amortization, eliminated the minimum liquidity covenant and set the minimum trailing four-quarter U.S. ZYNLONTA sales covenant at $65.0 million for the quarter ending December 31, 2026 and each quarter thereafter. Following this prepayment, the outstanding principal balance under the Loan Agreement was $50.0 million. The exercise price for the warrants to purchase an aggregate of 527,295 common shares that were issued to the lenders on August 15, 2022 was lowered from $8.30 per share to $1.00 per share.
Furthermore on October 22, 2026, a second amendment (the “Second HCR Amendment”) eliminated the payment otherwise required solely upon a change of control and permits the Company (or its successor in interest) to exercise its option to buy out the remaining royalty obligations without a change of control by paying HCR $525 million (if the buyout occurs on or prior to December 31, 2029) or $750 million (if the buyout occurs on or after January 1, 2030), less the amount of royalties previously paid to HCR. If this option is not exercised, the royalty obligations under the HCR Agreement will continue until the Royalty Cap (as defined in the HCR Agreement). In addition, the Second HCR Amendment reduces the aggregate outstanding principal amount of third-party indebtedness of the Company and its subsidiaries are permitted to incur to $50.0 million. An uncured breach of this debt limitation covenant entitles HCR to elect to receive the non-performance payment equaling 1.5 times the difference between the $300 million aggregate purchase price and royalty payments and other qualifying credited amounts actually received by HCR, subject to a cure period. The exercise price for the warrants to purchase an aggregate of 9,834,776 common shares that were issued to HCR on February 18, 2026 was lowered from $3.81 per share to $0.10 per share.
Uses of Capital Resources
Our primary uses of capital are, and we expect will continue to be, research and development expenses, selling and marketing expenses, compensation and related expenses, interest and principal payments on debt obligations and other operating expenses. We expect to incur substantial expenses as we continue to devote substantial resources to research and development and marketing and commercialization efforts, in particular to grow ZYNLONTA in the 3L+ DLBCL setting, continue to study and advance ZYNLONTA in earlier lines of therapy and in combinations to potentially expand our market opportunity. Cash used to fund operating expenses is impacted by the timing of when we pay expenses, as reflected in the change in our outstanding accounts payable and accrued expenses, as well as the timing of collecting receivables from the sale of ZYNLONTA and paying royalties related to our deferred royalty obligation.
Cash Flows
The following table summarizes our cash flows for the nine months ended September 30, 2026 and 2025:
| | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, |
| (in thousands) | 2026 | | 2025 | | Change |
| Net cash (used in) provided by: | | | | | |
| Operating activities | $ | (69,395) | | | $ | (110,051) | | | $ | 40,656 | |
| Investing activities | (32) | | | (264) | | | 232 | |
| Financing activities | (2,787) | | | 93,856 | | | (96,643) | |
| Net change in cash and cash equivalents | $ | (72,214) | | | $ | (16,459) | | | $ | (55,755) | |
Operating Activities
Net cash used in operating activities was $69.4 million for the nine months ended September 30, 2026 as compared to $110.1 million for the nine months ended September 30, 2025, a decrease of $40.7 million. The decrease was primarily due to the prior year payment of the 2023 discarded drug rebate of $7.2 million, a $10.8 million period over period increase in the collection of accounts receivable and overall reduction in net loss and operating costs in connection with the 2025 and 2026 Restructuring Plans, partially offset by $10.9 million in cash-based retention awards paid during the year and the $5 million SOBI milestone received in prior year in connection with ZYNLONTA’s conditional approval by Health Canada for the treatment of relapsed or refractory DLBCL after two or more lines of systemic therapy.
Investing Activities
Net cash used in investing activities was less than $0.1 million for the nine months ended September 30, 2026 as compared to $0.3 million for the nine months ended September 30, 2025, a decrease of $0.2 million. The decrease in net cash used in investing activities relates to timing of purchases of property and equipment.
Financing Activities
Net cash used in financing activities was $2.8 million for the nine months ended September 30, 2026 and primarily related to the first principal payment on our term loans and taxes paid related to net settled equity awards. Net cash provided by financing activities was $93.9 million for the nine months ended September 30, 2025 and primarily related to the net proceeds received from the completion of the Company’s 2025 Private Placement in June 2025.
Off-Balance Sheet Arrangements
During the periods presented, we did not have, and we do not currently have, any off-balance sheet arrangements.
Contractual Obligations and Commitments
Except as described below, there have been no material changes from the contractual obligations and commitments previously disclosed in our Annual Report.
On October 7, 2026, the Company entered into The Second HCR Amendment, which became effective on October 22, 2026 and eliminated the payment otherwise required solely upon a change of control and permits the Company (or its successor in interest) to exercise its option to buy out the remaining royalty obligations without a change of control by paying HCR $525 million (if the buyout occurs on or prior to December 31, 2029) or $750 million (if the buyout occurs on or after January 1, 2030), less the amount of royalties previously paid to HCR. If this option is not exercised, the royalty obligations under the HCR Agreement will continue until the Royalty Cap (as defined in the HCR Agreement). In addition,
the HCR Warrants to purchase 9,834,776 common shares, which were issued on February 18, 2026 in connection with the First HCR Amendment, was lowered from $3.81 per share to $0.10 per share.
On October 22, 2026, we prepaid $70.0 million of outstanding term loans under the Loan Agreement (inclusive of the Company’s September 30, 2026 amortization payment, plus related accrued interest, fees, and premiums) and an amendment to the Loan Agreement became effective which eliminated subsequent scheduled principal amortization, eliminated the minimum liquidity covenant and set the minimum trailing four-quarter U.S. ZYNLONTA sales covenant at $65.0 million for the quarter ending December 31, 2026 and each quarter thereafter. Following this prepayment, the outstanding principal balance under the Loan Agreement was $50.0 million. The exercise price for the warrants to purchase an aggregate of 527,295 common shares that were issued to the lenders on August 15, 2022 was lowered from $8.30 per share to $1.00 per share.
For more information regarding the specific terms of these amendments, see Note 16, “Subsequent events” to our unaudited condensed consolidated financial statements included in this Quarterly Report.
Critical Accounting Estimates
The preparation of our unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in our unaudited condensed consolidated financial statements. There have been no material changes to the critical accounting estimates previously disclosed in our Annual Report.
Recently Issued and Adopted Accounting Pronouncements
Refer to Note 2 to our unaudited condensed consolidated financial statements for recently adopted accounting pronouncements and recently issued accounting pronouncements not yet adopted as of the date of this Quarterly Report.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are not required to provide the information required by this Item 3 as we are a smaller reporting company.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
Our management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, has performed an evaluation of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) as of the end of the period covered by this report, as required by Rule 13a-15(b) under the Exchange Act. Based upon this evaluation, our Chief Executive Officer and Chief Financial Officer, has concluded that, as of the end of the period covered by this Quarterly Report, our disclosure controls and procedures were effective in ensuring that the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified by the SEC’s rules and forms, and that the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes to internal control over financial reporting during the quarter ended September 30, 2026, that would have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II: OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. The results of litigation and claims cannot be predicted with certainty. As of the date of this Quarterly Report, we do not believe that we are party to any claim or litigation, the outcome of which would, individually or in the aggregate, be reasonably expected to have a material adverse effect on our business.
Item 1A. Risk Factors
Below we are providing, in supplemental form, an addition to our risk factors as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.
The FDA expressed substantial concerns that the results from the LOTIS-5 trial are not supportive of a favorable benefit-risk assessment or verification of clinical benefit.
Following the publication of topline results from the LOTIS-5, we discussed the results with the FDA. The FDA noted that the increased Grade 5 adverse events in the treatment arm, compared to the control arm, when assessed in the context of a marginal treatment benefit, poses, substantial concerns that the trial results are not supportive of a favorable benefit-risk assessment or verification of clinical benefit. In the event we decide not to submit an sBLA for LOTIS 5 (or a similar supplemental application in foreign jurisdictions) or in the event we submit an sBLA to the FDA for LOTIS-5 (or a similar supplemental application in foreign jurisdictions), the FDA and other regulatory authorities may determine that the data is insufficient for approval in earlier lines of therapy or for full approval in third-line or later setting. As a result, an additional confirmatory trial may be required, which will require significant time and resources and be subject to the same risks as other clinical trials and the timing and results of which are uncertain. While we are currently able to continue to commercialize ZYNLONTA in the third line or later setting under its existing accelerated approval in the United States (and our partners in other jurisdiction are able to commercialize under similar conditional approvals), continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial. The LOTIS-5 trial results could lead regulatory authorities to seek withdrawal of current approvals for ZYNLONTA as a monotherapy in 3L+DLBCL. Further, the results of the LOTIS-5 trial and the perception of the benefit-risk profile of the drug could adversely affect sales of the product and affect enrollment and participation in and perception of our other clinical trials involving ZYNLONTA for other indications and likelihood of approval or compendia inclusion for other indications.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Recent Sales of Unregistered Securities
There were no sales of unregistered equity securities during the period covered by this report.
Issuer Purchases of Equity Securities
There were no purchases of our equity securities by or on behalf of us or any affiliated purchaser during the period covered by this report.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosure
Not applicable.
Item 5. Other Information
Insider Trading Arrangements
None of our directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the period covered by this report.
Item 6. Exhibits
Exhibits
The exhibits listed below are filed with or incorporated by reference into this Quarterly Report.
| | | | | | | | | | | | | | | | | | | | |
| | | Incorporation by Reference |
| Exhibit No. | Description | | Form | File No. | Exhibit No. | Filing Date |
| 3.1 | Articles of Association of ADC Therapeutics SA | | 8-K | 001-39071 | 3.1 | June 2, 2026 |
| 10.1 | Form of Securities Purchase Agreement | | 8-K | 001-39071 | 10.1 | October 13, 2026 |
| 10.2 | Form of Pre-Funded Warrant | | 8-K | 001-39071 | 10.2 | October 13, 2026 |
| 10.3 | Amendment No.2 to Loan Agreement between ADC Therapeutics SA, certain subsidiaries, the lenders party thereto and Blue owl Opportunistic Lending Master Fund I, L, P, dated October 7, 2026 | | 8-K | 001-39071 | 10.3 | October 13, 2026 |
| 10.4 | Form of Amendment to Lender Warrants | | 8-K | 001-39071 | 10.4 | October 13, 2026 |
| 10.5 | Amendment No.2 to Purchase and Sale Agreement between ADC Therapeutics SA and entities managed by HealthCare Royalty Management, LLC, dated October 7, 2026 | | 8-K | 001-39071 | 10.5 | October 13, 2026 |
| 10.6* | Incentive Award Agreement with Ameet Mallik | | 10-Q | 001-39071 | 10.2 | August 13, 2026 |
| 10.7* | Incentive Award Agreement with Jose Carmona | | 10-Q | 001-39071 | 10.3 | August 13, 2026 |
| 10.8* | Incentive Award Agreement with Mohamed Zaki | | 10-Q | 001-39071 | 10.4 | August 13, 2026 |
| 31.1* | Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | | | | | |
| 31.2* | Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | | | | | |
| 32.1* | Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | | | | | |
| 32.2* | Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | | | | | |
| 101.INS | XBRL Taxonomy Instance Document | | | | | |
| 101.SCH | XBRL Taxonomy Extension Schema Document | | | | | |
| 101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | | | | | |
| 101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | | | | | |
| 101.LAB | XBRL Taxonomy Extension Label Linkbase Document | | | | | |
| 101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | | | | | |
| 104 | Cover Page Interactive Data File (embedded with the Inline XBRL document and contained in Exhibit 101) | | | | | |
* Filed herewith.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| | | | | | | | | | | |
| | ADC Therapeutics SA |
| | | |
| | | /s/ Ameet Mallik |
Date: November 9, 2026 | | By: | Ameet Mallik |
| | | Chief Executive Officer |
| | | (Principal Executive Officer) |
| | | |
| | | | | | | | | | | |
| | | /s/ Jose Carmona |
Date: November 9, 2026 | | By: | Jose Carmona |
| | | Chief Financial Officer |
| | | (Principal Financial Officer) |
| | | |
| | | | | | | | | | | |
| | | /s/ Lisa Kallebo |
Date: November 9, 2026 | | By: | Lisa Kallebo |
| | | Corporate Controller and Chief Accounting Officer |
| | | (Principal Accounting Officer) |
| | | |