IOVANCE BIOTHERAPEUTICS, INC.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 5, 2026
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Item 1. Condensed Consolidated Financial Statements (Unaudited)
Condensed Consolidated Balance Sheets
(unaudited; in thousands, except share and per share information)
| September 30, · December 31, | ||||
|---|---|---|---|---|
| 2026 · 2025 | ||||
| ASSETS | ||||
| Current Assets | ||||
| Cash and cash equivalents | $ | 57,934 | $ | 163,078 |
| Trade accounts receivable | 106,988 | 82,448 | ||
| Short-term investments | 318,386 | 133,902 | ||
| Inventory | 55,222 | 51,678 | ||
| Prepaid expenses and other assets | 11,105 | 11,583 | ||
| Total Current Assets | 549,635 | 442,689 | ||
| Property and equipment, net | 129,310 | 131,112 | ||
| Intangible assets, net | 259,206 | 279,324 | ||
| Operating lease right-of-use assets | 42,564 | 45,899 | ||
| Restricted cash | 6,018 | 5,980 | ||
| Long-term assets | 4,481 | 8,166 | ||
| Total Assets | $ | 991,214 | $ | 913,170 |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||
| Current Liabilities | ||||
| Accounts payable | $ | 21,645 | $ | 22,159 |
| Accrued expenses and other liabilities | 81,685 | 111,156 | ||
| Note payable - current | — | 1,000 | ||
| Operating lease liabilities | 2,444 | 4,043 | ||
| Total Current Liabilities | 105,774 | 138,358 | ||
| Non-Current Liabilities | ||||
| Operating lease liabilities – non-current | 42,766 | 44,401 | ||
| Deferred tax liabilities | 30,012 | 31,828 | ||
| Total Non-Current Liabilities | 72,778 | 76,229 | ||
| Total Liabilities | 178,552 | 214,587 | ||
| Commitments and contingencies | ||||
| Stockholders’ Equity | ||||
| Series A Convertible Preferred stock, $0.001 par value; 17,000 shares designated, 194 shares issued and outstanding as of September 30, 2026 and December 31, 2025 | — | — | ||
| Series B Convertible Preferred stock, $0.001 par value; 11,500,000 shares designated, 1,932,667 shares issued and outstanding as of September 30, 2026 and December 31, 2025 | 2 | 2 | ||
| Common stock, $0.000041666 par value; 650,000,000 shares authorized, 462,543,386 and 411,938,061 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively | 19 | 17 | ||
| Accumulated other comprehensive income | 13,853 | 16,440 | ||
| Additional paid-in capital | 3,722,949 | 3,457,654 | ||
| Accumulated deficit | (2,924,161) | (2,775,530) | ||
| Total Stockholders’ Equity | 812,662 | 698,583 | ||
| Total Liabilities and Stockholders’ Equity | $ | 991,214 | $ | 913,170 |
Condensed Consolidated Statements of Operations
(unaudited; in thousands, except per share information)
| Three Months Ended · Nine Months Ended | ||||||||
|---|---|---|---|---|---|---|---|---|
| September 30, · September 30, | ||||||||
| 2026 · 2025 · 2026 · 2025 | ||||||||
| Revenue | ||||||||
| Product revenue, net | $ | 121,469 | $ | 67,455 | $ | 292,212 | $ | 176,731 |
| Total revenue | 121,469 | 67,455 | 292,212 | 176,731 | ||||
| Costs and expenses * | ||||||||
| Cost of sales ** | $ | 48,028 | $ | 38,477 | $ | 134,121 | $ | 130,073 |
| Research and development ** | 49,337 | 75,174 | 170,675 | 229,067 | ||||
| Selling, general, and administrative ** | 38,575 | 34,555 | 116,796 | 115,922 | ||||
| Depreciation and amortization | 9,497 | 9,007 | 27,536 | 26,422 | ||||
| Restructuring charges | — | 5,143 | — | 5,143 | ||||
| Total costs and expenses | $ | 145,437 | $ | 162,356 | $ | 449,128 | $ | 506,627 |
| Loss from operations | (23,968) | (94,901) | (156,916) | (329,896) | ||||
| Other income | ||||||||
| Interest and other income, net | 2,311 | 1,243 | 6,861 | 8,567 | ||||
| Net Loss before income taxes | $ | (21,657) | $ | (93,658) | $ | (150,055) | $ | (321,329) |
| Income tax (expense) benefit | (614) | 2,405 | 1,424 | 2,255 | ||||
| Net Loss | $ | (22,271) | $ | (91,253) | $ | (148,631) | $ | (319,074) |
| Net Loss Per Share of Common Stock, Basic and Diluted | $ | (0.05) | $ | (0.25) | $ | (0.34) | $ | (0.94) |
| Weighted Average Shares of Common Stock Outstanding, Basic and Diluted | 455,919 | 364,037 | 442,683 | 340,623 | ||||
| * Non-cash stock-based compensation included in cost of sales and operating expenses | ||||||||
| Cost of sales | $ | 1,721 | $ | 1,408 | $ | 4,276 | $ | 5,977 |
| Research and development | 4,771 | 5,011 | 14,966 | 21,287 | ||||
| Selling, general, and administrative | 5,341 | 5,481 | 15,593 | 22,494 | ||||
| $ | 11,833 | $ | 11,900 | $ | 34,835 | $ | 49,758 | |
| ** Excludes depreciation and amortization | ||||||||
Condensed Consolidated Statements of Comprehensive Income (Loss)
(unaudited; in thousands)
| Three Months Ended · Nine Months Ended | ||||||||
|---|---|---|---|---|---|---|---|---|
| September 30, · September 30, | ||||||||
| 2026 · 2025 · 2026 · 2025 | ||||||||
| Net Loss | $ | (22,271) | $ | (91,253) | $ | (148,631) | $ | (319,074) |
| Other comprehensive income (loss): | ||||||||
| Unrealized income (loss) on investments | (114) | 100 | (251) | (40) | ||||
| Foreign currency cumulative translation adjustment | 889 | (4,856) | (2,336) | 17,189 | ||||
| Comprehensive Loss | $ | (21,496) | $ | (96,009) | $ | (151,218) | $ | (301,925) |
Condensed Consolidated Statements of Stockholders’ Equity
For the Three Months Ended September 30, 2026 and 2025
(unaudited; in thousands, except share information)
| Series A · Series B · Accumulated | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Convertible · Convertible · Additional · Other · Total | |||||||||||||||||
| Preferred Stock · Preferred Stock · Common Stock · Paid-In · Comprehensive · Accumulated · Stockholders’ | |||||||||||||||||
| Shares · Amount · Shares · Amount · Shares · Amount · Capital · Income · Deficit · Equity | |||||||||||||||||
| Balance - June 30, 2026 | 194 | $ | — | 1,932,667 | $ | 2 | 452,971,016 | $ | 19 | $ | 3,624,836 | $ | 13,078 | $ | (2,901,890) | $ | 736,045 |
| Stock-based compensation expense | — | — | — | — | — | — | 11,830 | — | — | 11,830 | |||||||
| Common stock issued upon purchase of employee stock purchase plan | — | — | — | — | — | — | — | — | — | — | |||||||
| Vesting of restricted shares issued for services | — | — | — | — | 1,095,918 | — | — | — | — | — | |||||||
| Tax payments related to shares retired for vested restricted stock units | — | — | — | — | (291,011) | — | (2,419) | — | — | (2,419) | |||||||
| Common stock issued upon exercise of stock options | — | — | — | — | 100,809 | — | 805 | — | — | 805 | |||||||
| Common stock sold in public and/or at the market offering, net of offering costs | — | — | — | — | 8,666,654 | — | 87,897 | — | — | 87,897 | |||||||
| Unrealized loss on investments | — | — | — | — | — | — | — | (114) | — | (114) | |||||||
| Foreign currency cumulative translation adjustment | — | — | — | — | — | — | — | 889 | — | 889 | |||||||
| Net loss | — | — | — | — | — | — | — | — | (22,271) | (22,271) | |||||||
| Balance - September 30, 2026 | 194 | $ | — | 1,932,667 | $ | 2 | 462,543,386 | $ | 19 | $ | 3,722,949 | $ | 13,853 | $ | (2,924,161) | $ | 812,662 |
| Balance - June 30, 2025 | 194 | $ | — | 1,932,667 | $ | 2 | 341,919,364 | $ | 14 | $ | 3,289,986 | $ | 20,859 | $ | (2,612,373) | $ | 698,488 |
| Stock-based compensation expense | — | — | — | — | — | — | 11,751 | — | — | 11,751 | |||||||
| Common stock issued upon purchase of employee stock purchase plan | — | — | — | — | 1,455 | — | 3 | — | — | 3 | |||||||
| Vesting of restricted shares issued for services | — | — | — | — | 509,742 | — | — | — | — | — | |||||||
| Tax payments related to shares retired for vested restricted stock units | — | — | — | — | (211,322) | — | (464) | — | — | (464) | |||||||
| Common stock sold in public and/or at the market offerings, net of offering costs | — | — | — | — | 43,242,489 | 2 | 88,516 | — | — | 88,518 | |||||||
| Unrealized gain on investments | — | — | — | — | — | — | — | 100 | — | 100 | |||||||
| Foreign currency cumulative translation adjustment | — | — | — | — | — | — | — | (4,856) | — | (4,856) | |||||||
| Net loss | — | — | — | — | — | — | — | — | (91,253) | (91,253) | |||||||
| Balance - September 30, 2025 | 194 | $ | — | 1,932,667 | $ | 2 | 385,461,728 | $ | 16 | $ | 3,389,792 | $ | 16,103 | $ | (2,703,626) | $ | 702,287 |
Condensed Consolidated Statements of Stockholders’ Equity
For the Nine Months Ended September 30, 2026 and 2025
(unaudited; in thousands, except share information)
| Series A · Series B · Accumulated | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Convertible · Convertible · Additional · Other · Total | |||||||||||||||||
| Preferred Stock · Preferred Stock · Common Stock · Paid-In · Comprehensive · Accumulated · Stockholders’ | |||||||||||||||||
| Shares · Amount · Shares · Amount · Shares · Amount · Capital · Income · Deficit · Equity | |||||||||||||||||
| Balance - December 31, 2025 | 194 | $ | — | 1,932,667 | $ | 2 | 411,938,061 | $ | 17 | $ | 3,457,654 | $ | 16,440 | $ | (2,775,530) | $ | 698,583 |
| Stock-based compensation expense | — | — | — | — | — | — | 35,391 | — | — | 35,391 | |||||||
| Common stock issued upon purchase of employee stock purchase plan | — | — | — | — | 448,277 | — | 861 | — | — | 861 | |||||||
| Vesting of restricted shares issued for services | — | — | — | — | 4,000,228 | — | — | — | — | — | |||||||
| Tax payments related to shares retired for vested restricted stock units | — | — | — | — | (1,538,852) | — | (7,764) | — | — | (7,764) | |||||||
| Common stock issued upon exercise of stock options | — | — | — | — | 109,441 | — | 831 | — | — | 831 | |||||||
| Common stock sold in public and/or at the market offering, net of offering costs | — | — | — | — | 47,586,231 | 2 | 235,976 | — | — | 235,978 | |||||||
| Unrealized loss on investments | — | — | — | — | — | — | — | (251) | — | (251) | |||||||
| Foreign currency cumulative translation adjustment | — | — | — | — | — | — | — | (2,336) | — | (2,336) | |||||||
| Net loss | — | — | — | — | — | — | — | — | (148,631) | (148,631) | |||||||
| Balance - September 30, 2026 | 194 | $ | — | 1,932,667 | $ | 2 | 462,543,386 | $ | 19 | $ | 3,722,949 | $ | 13,853 | $ | (2,924,161) | $ | 812,662 |
| Balance - December 31, 2024 | 194 | $ | — | 2,842,158 | $ | 3 | 305,252,194 | $ | 13 | $ | 3,095,987 | $ | (1,046) | $ | (2,384,552) | $ | 710,405 |
| Stock-based compensation expense | — | — | — | — | — | — | 49,206 | — | — | 49,206 | |||||||
| Common stock issued upon purchase of employee stock purchase plan | — | — | — | — | 357,163 | — | 671 | — | — | 671 | |||||||
| Vesting of restricted shares issued for services | — | — | — | — | 4,651,490 | — | — | — | — | — | |||||||
| Tax payments related to shares retired for vested restricted stock units | — | — | — | — | (1,856,719) | — | (6,614) | — | — | (6,614) | |||||||
| Common stock issued upon exercise of stock options | — | — | — | — | 2,586 | — | 15 | — | — | 15 | |||||||
| Common stock sold in public and/or at the market offering, net of offering costs | — | — | — | — | 76,145,523 | 3 | 250,526 | — | — | 250,529 | |||||||
| Common stock issued from preferred stock conversion | — | — | (909,491) | (1) | 909,491 | — | 1 | — | — | — | |||||||
| Unrealized loss on investments | — | — | — | — | — | — | — | (40) | — | (40) | |||||||
| Foreign currency cumulative adjustments | — | — | — | — | — | — | — | 17,189 | — | 17,189 | |||||||
| Net loss | — | — | — | — | — | — | — | — | (319,074) | (319,074) | |||||||
| Balance - September 30, 2025 | 194 | $ | — | 1,932,667 | $ | 2 | 385,461,728 | $ | 16 | $ | 3,389,792 | $ | 16,103 | $ | (2,703,626) | $ | 702,287 |
Condensed Consolidated Statements of Cash Flows
(unaudited; in thousands)
| Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | ||||
| 2026 · 2025 | ||||
| Cash Flows from Operating Activities | ||||
| Net loss | $ | (148,631) | $ | (319,074) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||
| Stock-based compensation expense | 34,835 | 49,758 | ||
| Unrealized foreign exchange loss (gain) | 497 | 135 | ||
| Amortization of intangible assets | 17,133 | 16,873 | ||
| Amortization of right of use asset | 3,695 | 8,669 | ||
| Depreciation and amortization of property and equipment | 10,404 | 9,138 | ||
| Deferred tax benefit | (1,424) | (2,255) | ||
| Excess and obsolescence reserve | 2,808 | 9,702 | ||
| Accretion of discounts and premiums on investments | (4,318) | (5,860) | ||
| Loss on asset disposals | 672 | 44 | ||
| Gain on loan forgiveness | (1,000) | — | ||
| Changes in assets and liabilities: | ||||
| Prepaid expenses, other assets and long-term assets | 4,162 | (7,362) | ||
| Trade accounts receivable | (24,540) | 2,579 | ||
| Inventory | (4,512) | (10,210) | ||
| Operating lease liabilities | (3,592) | (8,000) | ||
| Accounts payable | 1,471 | (1,448) | ||
| Accrued expenses and other liabilities | (25,045) | 7,468 | ||
| Net cash used in operating activities | (137,385) | (249,843) | ||
| Cash Flows from Investing Activities | ||||
| Maturities of investments | 192,000 | 330,000 | ||
| Purchase of investments | (372,416) | (258,763) | ||
| Purchase of property and equipment | (16,785) | (24,516) | ||
| Purchase of intangible assets | (100) | — | ||
| Net cash provided by (used in) investing activities | (197,301) | 46,721 | ||
| Cash Flows from Financing Activities | ||||
| Tax payments related to shares withheld for vested restricted stock units | (7,764) | (6,614) | ||
| Proceeds from the issuance of common stock under employee stock purchase plan | 861 | 671 | ||
| Proceeds from the issuance of common stock upon exercise of options | 831 | 15 | ||
| Proceeds from the issuance of common stock, net | 235,978 | 250,529 | ||
| Net cash provided by financing activities | 229,906 | 244,601 | ||
| Effect of foreign exchange rate changes | (326) | 567 | ||
| Net increase (decrease) in cash, cash equivalents and restricted cash | (105,106) | 42,046 | ||
| Cash, Cash Equivalents and Restricted Cash Beginning of Period | 169,058 | 122,053 | ||
| Cash, Cash Equivalents and Restricted Cash End of Period | $ | 63,952 | $ | 164,099 |
| Supplemental disclosure of non-cash investing and financing activities: | ||||
| Net unrealized loss on investments | 251 | 40 | ||
| Acquisition of property and equipment included in accounts payable and accrued expenses | 2,275 | 9,834 | ||
| Conversion of convertible preferred stock to common stock | — | 1 | ||
| Increase in lease liabilities due to obtaining right-of-use assets from lease modifications | 359 | 2,231 | ||
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
NOTE 1. GENERAL ORGANIZATION, BUSINESS AND LIQUIDITY
General Organization and Business
Iovance Biotherapeutics, Inc. (the “Company”) is a commercial-stage biopharmaceutical company pioneering a transformational approach to treating cancer. The Company’s mission is to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (“TIL”) cell therapies for patients with solid tumor cancers. TIL cell therapies harness the individual immune system’s ability to recognize and destroy cancer cells that are unique to each patient. These individualized therapies are manufactured using centralized, scalable, and proprietary manufacturing processes which rejuvenate and multiply each patient’s polyclonal T cells into the billions.
The Company was founded to build upon the promise of TIL cell therapy initially developed at academic research centers, including the National Cancer Institute (“NCI”). The Company’s multi-center trials, scalable manufacturing, regulatory approvals, and commercial infrastructure have transformed TIL cell therapy from a research product available to only a small number of patients into a commercially viable treatment that is accessible for thousands of cancer patients globally.
The Company’s two commercial products include Amtagvi® (lifileucel), and Proleukin® (aldesleukin), an interleukin-2 (“IL-2”) product used in the Amtagvi® treatment regimen and in other applications.
Amtagvi® is the first one-time, individualized T cell therapy for a solid tumor cancer and for the treatment of adult patients with previously treated advanced melanoma, defined as unresectable or metastatic melanoma, approved for use in the U.S., Canada, and Australia. Amtagvi® is administered as part of a treatment regimen that includes lymphodepletion and a short course of Proleukin®.
Globally, Amtagvi® has the potential to address tens of thousands of previously treated advanced melanoma patients annually. The Company plans to launch Amtagvi® into additional markets with a high prevalence of advanced melanoma. On June 4, 2026, the Company received marketing authorization with conditions from the Therapeutic Goods Administration of Australia for Amtagvi® for previously treated advanced (metastatic or unresectable) melanoma. In the United Kingdom (“UK”), the Company resubmitted the marketing authorization application (“MAA”) with additional information in July 2026. The Medicines and Healthcare products Regulatory Agency (“MHRA”) is conducting an expedited review, with potential approval expected in the first quarter of 2027. Potential approval is pending in Switzerland in the first quarter of 2027. In the European Union (“EU”), the Company is working with the European Medicines Agency (“EMA”) to resubmit a centralized MAA in 2027.
The Company’s development pipeline consists of TIL cell therapies in additional solid tumor cancer indications as monotherapy or in combination with standard of care, as well as next generation approaches. The Company is conducting two ongoing registrational trials in frontline advanced melanoma and previously treated advanced non-small cell lung cancer (“NSCLC”). The Company has commenced a registrational trial in previously treated advanced undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma, and plans to engage with the FDA for an expedited path to accelerated approval.
Basis of Presentation of Unaudited Condensed Consolidated Financial Information
The accompanying unaudited condensed consolidated financial statements of the Company for the three and nine months ended September 30, 2026 and 2025 have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) for interim financial information and pursuant to the requirements for reporting on Form 10-Q and Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for audited financial statements. However, such information reflects all adjustments (consisting solely of normal recurring adjustments), which are, in the opinion of management, necessary for the fair presentation of the Company's financial position and results of operations. Results shown for interim periods are not necessarily indicative of the results that may be expected for the year ended December 31, 2026 or for any other period. The condensed consolidated balance sheet as of December 31, 2025 was derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10‑K filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 24, 2026.
Liquidity
As of September 30, 2026, the Company had $382.3 million in cash, cash equivalents, short-term investments, and restricted cash ($57.9 million of cash and cash equivalents, $318.4 million in short-term investments, and $6.0 million in restricted cash). The Company has launched its first internally developed commercial product and continues to be engaged in the development of therapeutics to fight cancer, specifically solid tumors. With the approval of the Biologics License Application (“BLA”), the Company began to generate revenue from the sale of its product Amtagvi® in the second quarter of 2024. Furthermore, following the acquisition of the worldwide rights to Proleukin® (as discussed below in Note 4 – Intangible Assets, Net) in 2023, the Company began to generate revenue from the sales of Proleukin®. However, such revenues may not be material enough to generate positive operational cash flows during the 12 months from the date the condensed consolidated financial statements are issued and this Form 10-Q is filed. The Company has incurred a net loss of $148.6 million for the nine months ended September 30, 2026, and used $137.4 million of cash in its operating activities during the nine months ended September 30, 2026.
The Company expects to continue to incur significant expenses to support commercial activities for Amtagvi®, fund ongoing clinical programs, including its NSCLC registrational study, IOV-LUN-202, and its frontline advanced melanoma Phase 3 confirmatory trial, TILVANCE-301, continue the development of its pipeline candidates, and for other general corporate purposes. Based on the funds the Company has available as of the date these condensed consolidated financial statements are issued, the Company believes that it has sufficient capital to fund its anticipated operating expenses and capital expenditures as planned for at least the next twelve months from the date these condensed consolidated financial statements are issued.
Concentrations of Risk
The Company is subject to credit risk from its portfolio of cash, cash equivalents, trade accounts receivable and investments. Under its investment policy, the Company limits amounts invested in securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. The Company does not believe it is exposed to any significant concentrations of credit risk from these financial instruments. The goals of its investment policy are safety and preservation of principal, diversification of risk, and liquidity of investments sufficient to meet cash flow requirements.
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Cash, Cash Equivalents, and Investments
The Company’s cash and cash equivalents include short-term investments with original maturities of three months or less when purchased. The Company's investments are classified as “available-for-sale.” The Company includes these investments in current assets or non-current assets in the condensed consolidated balance sheets based on the length of maturity from the reporting date and carries them at fair value. Unrealized gains and losses on available-for-sale securities are recorded in accumulated other comprehensive income (loss). Impairment losses related to credit losses (if any) are recorded as an allowance for credit losses with an offsetting entry to Interest and other income, net. No impairment losses related to credit losses were recognized for thethree and nine months ended September 30, 2026, and 2025. The cost of debt securities is adjusted for the amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in Interest and other income, net in the condensed consolidated statements of operations. Gains and losses on securities sold are recorded based on the specific identification method and are included in Interest and other income, net in the condensed consolidated statements of operations. The Company has not incurred any realized gains or losses from sales of securities to date. The Company’s investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as corporate debt securities and commercial paper, and places restrictions on maturities and concentration by type and issuer, except for securities issued by the U.S. government.
Restricted Cash
As of September 30, 2026 and December 31, 2025, restricted cash totaled $6.0 million, respectively. These amounts have been classified as non-current assets in the Company’s condensed consolidated balance sheet based on the maturity date of the underlying letter of credit agreement.
The Company maintains a required minimum balance in segregated bank accounts in connection with its letters of credit for which amounts are restricted as to their use by the Company. As of September 30, 2026, the Company’s letters of credit were primarily comprised of a letter of credit for the benefit of thei CTC used as a security deposit for the lease in the amount of $5.45 million. The letter of credit for $5.45 million originally expired on May 28, 2020, however, it automatically extends for additional one-year periods, without written agreement, to May 28 in each succeeding calendar year, through at least 60 days after the lease expiration date. Further, on the expiration of the seventh year of the lease, and each anniversary date thereafter, the letter of credit may be decreased by $1.0 million, with a minimum security deposit of $1.5 million maintained through the end of the lease term. The letter of credit with the landlord for the Company’s California office lease expires on February 1, 2032, however, it will be automatically extended, without written agreement, for one-year periods to February in each succeeding calendar year.
The following table provides a reconciliation of cash, cash equivalents, and restricted cash, reported within the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands):
| September 30, | ||||
|---|---|---|---|---|
| 2026 · 2025 | ||||
| Cash and cash equivalents | $ | 57,934 | $ | 158,134 |
| Restricted cash | 6,018 | 5,965 | ||
| Total cash, cash equivalents and restricted cash | $ | 63,952 | $ | 164,099 |
Asset Acquisitions
The Company evaluates acquisitions of assets using the guidance in Accounting Standard Codification (“ASC”) Topic 805, Business Combinations (“ASC 805”), to determine whether the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to assess if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of assets. If the screen test is met, the transaction is accounted for as an asset acquisition. If the screen test is not met, further assessment is required to determine whether the Company has acquired inputs and processes that have the ability to create outputs, which would meet the requirements of a business.
If the assets acquired do not constitute a business, the Company accounts for asset acquisitions using the cost accumulation and allocation method. Under this method, the cost of the acquisition, including direct acquisition-related costs, is allocated to the assets acquired on a relative fair value basis. Goodwill is not recognized in an asset acquisition and any difference between consideration transferred and the fair value of the net assets acquired is allocated to the identifiable assets acquired based on their relative fair values.
Deferred tax liabilities arising from basis differences in assets acquired are calculated using the simultaneous equations method under ASC Topic 740, Income Taxes (“ASC 740”), and based on the effective tax rate. The resulting deferred tax liability is recorded in the condensed consolidated balance sheet as of September 30, 2026 and December 31, 2025.
Contingent consideration in the scope of ASC Topic 815, Derivatives and Hedging (“ASC 815”), is included in the cost of the asset acquisition at its acquisition date fair value. Contingent consideration in the scope of ASC Topic 450, Contingencies (“ASC 450”), is recognized when it is both probable and reasonably estimable.
Inventory and Cost of Sales
Inventory is stated at the lower of cost or net realizable value on a first-in, first-out basis. Cost includes amounts related to materials, internal labor, costs of external manufacturing, and overhead. Net realizable value is the estimated selling price in the ordinary course of business less reasonably predictable costs of completion, disposal and transportation. Certain costs incurred, such as manufacturing costs incurred prior to regulatory approval that did not qualify for capitalization and clinical manufacturing costs, are expensed as incurred as research and development expenses.
Upon the February 2024 approval of Amtagvi®, the Company began capitalizing inventory and manufacturing costs for the commercial manufacturing of Amtagvi®. Additionally, inventory that initially qualifies for capitalization but that may ultimately be used for the production of clinical drug product or utilized in research and development programs is expensed as research and development expense when it has been designated for the manufacture of clinical drug product or use in research and development activities.
The Company periodically reviews inventory for excess and obsolescence, considering factors such as its most recent sales and manufacturing forecast compared to quantities on hand and the expiration date of the product and materials. The Company adjusts its inventory that is obsolete or otherwise unmarketable to its estimated net realizable value in the period in which the impairment is first identified. Any such adjustments are included as a component of cost of sales within the Company’s condensed consolidated statements of operations.
Cost of sales includes inventory and period costs related to overhead and manufacturing costs of Amtagvi®, as well as the cost of inventories and other costs that are directly associated with the purchase and sales of Proleukin®. In addition, cost of sales in the Company’s condensed consolidated statements of operations includes royalties payable on sales of its products.
During the Company’s commercial manufacturing process, certain Amtagvi® product may become out-of-specification, meaning they fall outside commercial specifications. This out-of-specification product can still be utilized by patients in a clinical trial, an expanded or early access program, or single-patient investigational new drug, at which point the costs associated with these batches are classified as research and development expense based on the fact that the Company receives clinical data related to these infusions.
Trade Accounts Receivable
Trade accounts receivable are recorded net of allowances for product returns and estimated credit losses. The estimate of allowance for credit losses considers factors, including existing contractual payment and the aging of receivable from its customers. To date, the Company has determined that an allowance for credit losses is not required.
Intangible Assets
The Company’s acquired intangible assets are initially measured based on an allocation of the cost of the acquisition to the assets acquired on a relative fair value basis and are recorded net of accumulated amortization, while intangible assets recorded as the result of milestone or license payments are recorded at the amount paid. The Company amortizes the intangible assets on a straight-line basis over their estimated useful lives.
When contingent consideration is a component of the cost of an asset acquisition, the Company capitalizes the amount of incremental cost from the contingent consideration related to the intangible asset acquired in the period the underlying contingency is resolved. When this occurs, the Company will recognize amortization expense on the incremental cost prospectively from the date the incremental costs are capitalized.
The Company reviews intangible assets for impairment at least annually and whenever events or changes in circumstances have occurred which could indicate that the carrying value of the assets are not recoverable. If such indicators are present, the Company assesses the recoverability of affected assets by determining if the carrying value of the assets is less than the sum of the undiscounted future cash flows of the assets. If the assets are found to not be recoverable, the Company measures the amount of impairment by comparing the carrying value of the assets to their fair values. The Company determined that no indicators of impairment existed as of September 30, 2026 or December 31, 2025.
Leases
The Company determines if an arrangement includes a lease at inception and thereafter, if modified. Operating leases are included in its condensed consolidated balance sheets as operating lease right-of-use assets and operating lease liabilities as of September 30, 2026 and December 31, 2025. Operating lease right-of-use assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date or modification date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses an estimated incremental borrowing rate that is applicable to the Company based on the information available at the later of the lease commencement or modification date.
The operating lease right-of-use assets also include any lease payments made less lease incentives. The Company’s leases may include options to extend or terminate the lease, which is considered in the lease term when it is reasonably certain that the Company will exercise any such options. Lease expense is recognized on a straight-line basis over the expected lease term and recorded in costs and expenses in the condensed consolidated statements of operations. The Company has elected not to apply the recognition requirements of Accounting Standards Update (“ASU”) No. 2016-02 and No. 2018-10 (together “Topic 842”) for short-term leases.
For lease agreements entered into by the Company that include lease and non-lease components, such components are generally accounted for separately.
Revenue Recognition
The Company recognizes revenue from product sales in accordance with ASC Topic 606, Revenue from Contracts with Customers(“ASC 606”). Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price using the most likely method based on historical experience, as well as applicable information currently available.
In the U.S., products are sold principally to hospitals and clinics, as well as distributors and wholesalers, and outside of the U.S. to hospitals and clinics. Contractual performance obligations are usually limited to transfer of control of the product to the customer. In the case of Amtagvi®, revenue is recognized primarily upon infusion while for Proleukin®, transfer of control occurs either upon shipment or upon receipt of the product after considering when the customer obtains legal title to the product. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring its products and is generally based on a list of fixed prices less allowances for chargebacks, product returns, rebates and discounts. The Company’s payment terms to customers range from 45 to 105 days; payment terms differ by customer and by product.
Revenue is reduced at the time of recognition for expected chargebacks, product returns, discounts, rebates, and sales allowances, collectively referred to as gross to net adjustments (“GTN adjustments”). In the U.S., these GTN adjustments are attributable to various commercial arrangements and government programs. In addition, non-U.S. government programs may include different pricing schemes such as cost caps and volume discounts. Cash discounts are recorded as a reduction to receivables and settled through the issuance of credits, typically within one month. All other GTN adjustments are recorded as a liability and settled through cash payments to the customer.
Judgment is required in estimating GTN adjustments considering legal interpretations of applicable laws and regulations, historical experience, payer channel mix, current contract prices under applicable programs, processing time lags and inventory levels in the distribution channel.
Indirect taxes collected from customers and remitted to government authorities that are related to sales of the Company’s products, primarily in Europe, are excluded from revenues.
Stock-Based Compensation
The Company periodically grants stock options to employees and non-employees as compensation for services rendered. The Company accounts for all stock-based payment awards made to employees, including the employee stock purchase plans, and non-employees in accordance with the authoritative guidance provided by the Financial Accounting Standards Board (“FASB”) where the value of the award is measured on the date of grant and recognized over the vesting period. Forfeitures are recognized in the period in which they occur. The Company accounts for stock option grants to non-employees in a similar manner as stock option grants to employees except for the term used in the grant date fair value, therefore no longer requiring a re-measurement at the then-current fair values at each reporting date until the shares underlying the options have vested. The non-employee awards that contain a performance condition that affects the quantity or other terms of the award are measured based on the outcome that is probable.
The fair value of the Company's common stock option grants is estimated using a Black-Scholes option pricing model, which uses certain assumptions related to risk-free interest rates, expected volatility, expected term of the common stock options, and future dividends. The stock-based compensation expense is recorded based upon the value derived from the Black-Scholes option pricing model. The assumptions used in the Black-Scholes option pricing model could affect compensation expense recorded in future periods.
The Company issues restricted stock units (“RSUs”) from time to time as part of its equity incentive plans. The Company measures the compensation cost with respect to RSUs issued to employees based upon the estimated fair value of the equity instruments at the date of the grant, which is recognized as an expense over the period during which an employee is required to provide services in exchange for the awards. The fair value of RSUs is based on the closing price of the Company’s common stock on the grant date. In addition to RSUs that have time-based vesting requirements, from time to time the Company may issue RSUs that include certain performance vesting criteria based upon the satisfaction of stated objectives (“PRSUs”). The Company measures the compensation cost with respect to PRSUs issued to employees based upon the estimated fair value of the equity instruments at the date of grant, which is recognized as an expense over the period that achievement is determined to be probable through the stated service period associated with the award.
Accrued Research and Development Costs
Research and development costs are expensed as incurred. Clinical development costs compose a significant component of research and development costs. The Company has a history of contracting with third parties, including contract research organizations (“CROs”), independent clinical investigators, and contract manufacturing organizations (“CMOs”) that perform various clinical trial activities on the Company’s behalf in connection with the ongoing development of the Company’s product candidates. The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in uneven payment flow. The Company accrues and expenses costs for clinical trial activities performed by third parties based upon the work completed to date for each clinical trial in accordance with agreements established with CROs, hospitals, and clinical investigators. Accruals for CROs and CMOs are recorded based on services received and efforts expended pursuant to agreements established with CROs, CMOs and other outside service providers. The Company determines its costs through discussions with internal clinical stakeholders and outside service providers as to the progress or stage of completion of clinical trials or services and the contracted fee to be paid for such services.
Included in the Company’s clinical development costs are investigator costs, which are costs associated with treatments administered at clinical sites as required under each clinical trial protocol. The Company’s determination of clinical investigator costs and related timing of expense recognition will depend on a number of factors that include, but are not limited to, (i) the overall number of patients that enroll in the trial at each individual site, (ii) the length of clinical trial enrollment period, (iii) discontinuation and completion rates of patients, (iv) duration of patient safety follow-ups, (v) the number of sites included in the clinical trial, and (vi) the contracted fee of each participating site for patient treatment while on clinical trial, which can vary greatly for several reasons including, but not limited to, geographic region, medical center or physician costs, and overhead costs. In addition, the Company’s estimates for per patient trial costs will vary based on a number of factors that include, but are not limited to, the extent of additional procedures that may be administered by investigators as a result of patient health status, recoverability of patient costs through insurance carriers of patients, and unanticipated cost of injuries incurred as a result of the clinical trial treatment. The Company accrues estimated expenses resulting from obligations under investigator site agreements as the timing of payments does not always timely align with the periods over which the treatments are administered by the clinical investigators. These estimates are typically based on contracted amounts, patient visit data, discussions with internal clinical stakeholders and outside service providers, and historical look-back analysis of actual payments made to date.
In the event advance payments are made to a CRO, CMO or other outside service provider, the payments are recorded within prepaid expenses and other current assets in the condensed consolidated balance sheets and subsequently recognized as research and development expense in the condensed consolidated statements of operations when the associated services have been performed. As actual costs become known, the Company adjusts its estimates, liabilities and assets. Inputs used in the determination of estimates discussed above may vary from actual, which will result in adjustments to research and development expense in future periods.
Selling, general, and administrative expense
Selling, general, and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in executive, finance, procurement, legal, investor relations, facilities, business development, marketing, commercial, information technology and human resources functions. Other significant costs include facility costs not otherwise capitalized in inventory or included in research and development expenses. Selling, general, and administrative costs are expensed as incurred, and the Company accrues for services provided by third parties related to such expenses by monitoring the status of services provided and receiving estimates from its service providers and adjusting its accruals as actual costs become known.
Restructuring Charges
Restructuring charges consist primarily of employee severance payments and other postemployment benefit related expenses. The Company records restructuring charges based on whether the termination benefits are provided under an on-going benefit arrangement or under a one-time benefit arrangement. The Company recognizes charges related to restructuring plans when the liabilities have been incurred and can be reasonably estimated.
Net Loss per Share
Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period.
Diluted net loss per share is computed by dividing the net loss by the sum of the weighted average number of shares of common stock outstanding and the dilutive common stock equivalent outstanding during the period. The Company’s potentially dilutive common stock equivalent shares, which include incremental common shares issuable upon (i) the exercise of outstanding stock options, (ii) vesting of restricted stock units, (iii) purchases through the 2020 Employee Stock Purchase Plan (the “2020 ESPP”), and (iv) conversion of preferred stock, are only included in the calculation of diluted net loss per share when their effect is dilutive.
As of September 30, 2026 and 2025, the following outstanding common stock equivalents have been excluded from the calculation of net loss per share because their impact would be anti-dilutive:
| September 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Stock options | 17,001,971 | 18,612,136 |
| Restricted stock units | 10,259,599 | 9,884,377 |
| Employee Stock Purchase Plan | 369,591 | 570,824 |
| Series A Convertible Preferred Stock* | 97,000 | 97,000 |
| Series B Convertible Preferred Stock* | 1,932,667 | 1,932,667 |
| 29,660,828 | 31,097,004 | |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.