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EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission File Number: 001-39979 VOR BIOPHARMA INC. (Exact Name of Registrant as Specified in its Charter) Delaware 81-1591163 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 500 Boylston Street Suite 1350 Boston , Massachusetts 02116 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: ( 617 ) 655-6580 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 Stock, $0.0001 par value per share VOR Nasdaq Global Select Market 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, 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 ☒ Number of shares of the registrant’s Common Stock outstanding as of August 6, 2026 was 59,162,294 . Table of Contents Page PART I. FINANCIAL INFORMATION 1 Item 1. Financial Statements (Unaudited) 1 Condensed Consolidated Balance Sheets as of June 30, 2026 and December 31, 2025 1 Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2026 and 2025 2 Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the Three and Six Months Ended June 30, 2026 and 2025 3 Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2026 and 2025 4 Notes to Condensed Consolidated Financial Statements (Unaudited) 5 Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 15 Item 3. Quantitative and Qualitative Disclosures About Market Risk 23 Item 4. Controls and Procedures 23 PART II. OTHER INFORMATION 24 Item 1. Legal Proceedings 24 Item 1A. Risk Factors 24 Item 5. Other Information 66 Item 6. Exhibits 67 Signatures 69 i Note Regarding Company References Throughout this Quarterly Report on Form 10-Q, the “Company,” “Vor,” “Vor Bio,” “Vor Biopharma Inc.,” “we,” “us,” and “our,” except where the context requires otherwise, refer to Vor Biopharma Inc. and its consolidated subsidiary, and “our board of directors” refers to the board of directors of Vor Biopharma Inc. Special Note Regarding Forward-Looking Statements This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “might,” “intend,” “target,” “ongoing,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions intended to identify statements about the future. These statements speak only as of the date of this Quarterly Report on Form 10-Q and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements include, without limitation, statements about: • the timing, progress and results of our clinical trials of our product candidate and any future product candidates, including statements regarding the timing and pace of initiation, enrollment and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and plans with respect to our research and development programs; • the timing of any submission of filings for regulatory approval of, and our ability to obtain and maintain regulatory approvals for, our product candidate and any future product candidates for any indication; • our ability to identify patients with the diseases treated by our product candidate and any future product candidates, and to enroll patients in clinical trials; • our expectations regarding the market acceptance and opportunity for and clinical utility of our product candidate and any future product candidates, if approved for commercial use; • our expectations regarding the scope of any approved indication for any product candidate; • our ability to successfully commercialize our product candidate or any future product candidates; • our estimates of our expenses, ongoing losses, future revenue and capital requirements and our need for or ability to obtain additional funding; • our ability to establish or maintain collaborations or strategic relationships; • our ability to identify, recruit and retain key personnel, including executive officers and members of management; • our reliance upon intellectual property licensed from third parties and our ability to obtain such licenses on commercially reasonable terms or at all; • our reliance on third-party contract manufacturing organizations and clinical manufacturing organizations and our ability to establish or maintain agreements on commercially reasonable terms; • our ability to protect and enforce our intellectual property position for our product candidate or any future product candidates, and the scope of such protection; • our financial performance; • the period over which we estimate our existing cash, cash equivalents and marketable securities will be sufficient to fund our future operating expenses and capital expenditure requirements; • the anticipated timing and availability of clinical trial data, including topline data; • our competitive position and the development of and projections relating to our competition or our industry; • the impact of laws and regulations; and • the sufficiency of our existing cash, cash equivalents and marketable securities to fund our operations; ii • our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012. You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements contained in this Quarterly Report on Form 10-Q are made as of the date of this Quarterly Report on Form 10-Q, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. You should refer to the “Risk Factors” section in this Quarterly Report for a discussion of material factors that could cause actual results or events to differ materially from the forward-looking statements that we make. This Quarterly Report on Form 10-Q includes statistical and other industry and market data, which we obtained from our own internal estimates and research, as well as from industry and general publications and research, surveys, and studies conducted by third parties. Industry publications, studies, and surveys generally state that they have been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we believe that each of these studies and publications is reliable, we have not independently verified market and industry data from third-party sources. While we believe our internal company research is reliable and the market definitions are appropriate, neither such research nor these definitions have been verified by any independent source. All brand names or trademarks appearing in this Quarterly Report on Form 10-Q are the property of their respective owners. Summary Risk Factors Our business is subject to a number of risks that if realized could materially affect our business, financial condition, results of operations, cash flows and access to liquidity. These risks are discussed more fully in the “Risk Factors” section of this Quarterly Report. Our principal risks include the following: • We have incurred significant net losses since inception. We expect to incur net losses for the foreseeable future and may never achieve or maintain profitability. • We will need substantial additional funding. If we are unable to raise capital when needed, we would be forced to delay, reduce or eliminate our research and product development programs or future commercialization efforts. • We have a limited operating history, have not yet completed any clinical trials and have no history of commercializing products, which may make it difficult to evaluate the success of our business to date and to assess our future viability. • We are substantially dependent on the success of our lead product candidate, telitacicept. If we are unable to complete development of, obtain approval for and commercialize telitacicept in a timely manner, our business will be harmed. • We may derive results and data for telitacicept from clinical trials conducted by RemeGen; our access to the clinical results and data may be limited or delayed, and there is no assurance that the clinical data from any such trials will be accepted or considered by the FDA or other comparable regulatory authorities. • We are dependent on third parties accurately generating and reporting data related to our product candidate, and their conduct could adversely affect our business. • We face significant competition in an environment of rapid technological change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer or more advanced or effective than ours, which may harm our financial condition and our ability to successfully market or commercialize our product candidates, if approved. • Success in preclinical studies or clinical trials may not be indicative of results in future clinical trials, particularly for our clinical trials that involve only a small number of patients. • If we experience significant delays or difficulties in the enrollment or retention of patients in clinical trials, the cost of developing product candidates could increase and our receipt of necessary regulatory approvals could be delayed or prevented. • We have contracted and will continue to contract with third parties for the manufacture and supply of materials for development of our product candidates, advancement of our current and future clinical trials, and potential commercialization of our product candidates. This reliance on third parties increases the risk that we will not have sufficient quantities and quality of such materials, product candidates or any products that we may develop and iii commercialize, or that such supply will not be available to us at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts. • We are highly dependent on intellectual property licensed from third parties and termination of these licenses could result in the loss of significant rights, which would harm our business. • Third-party claims of intellectual property infringement, misappropriation or other violations may prevent or delay our product discovery and development efforts and have a material adverse effect on our business. iv PART I—FINANCI AL INFORMATION Item 1. Financial Stat ements (Unaudited). VOR BIOPHARMA INC. CONDENSED CONSOLIDAT ED BALANCE SHEETS (UNAUDITED) June 30, December 31, (in thousands, except share and per share amounts) 2026 2025 Assets Current assets: Cash and cash equivalents $ 107,855 $ 396,486 Marketable securities 358,274 58,722 Prepaid expenses 5,875 1,152 Other current assets 3,103 1,745 Total current assets 475,107 458,105 Restricted cash 168 168 Property and equipment, net 648 533 Operating lease right-of-use assets 2,718 2,936 Other assets 2,412 2,384 Total assets $ 481,053 $ 464,126 Liabilities and stockholders’ deficit Current liabilities: Accounts payable $ 3,998 $ 5,127 Accrued liabilities 20,481 19,764 Operating lease liabilities 335 280 Total current liabilities 24,814 25,171 Non-current liabilities: Operating lease liabilities, less current portion 2,542 2,720 Warrant liabilities 653,894 600,547 Total liabilities 681,250 628,438 Stockholders’ deficit (1) : Preferred stock, $ 0.0001 par value; 10,000,000 shares authorized as of June 30, 2026 and December 31, 2025; 0 shares issued and outstanding as of June 30, 2026 and December 31, 2025 — — Common stock, $ 0.0001 par value; 800,000,000 and 400,000,000 shares authorized as of June 30, 2026 and December 31, 2025, respectively; 54,455,751 and 38,720,196 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively 19 18 Additional paid-in capital 1,236,073 988,604 Accumulated other comprehensive (loss) income ( 922 ) 41 Accumulated deficit ( 1,435,367 ) ( 1,152,975 ) Total stockholders’ deficit ( 200,197 ) ( 164,312 ) Total liabilities and stockholders’ deficit $ 481,053 $ 464,126 (1) All share and per share amounts have been restated for prior periods on a retroactive basis to reflect a one-for-twenty reverse stock split effected in September 2025. See Note 2 for details. The accompanying notes are an integral part of these condensed consolidated financial statements. 1 VOR BIOPHARMA INC. CONDENSED CONSOLIDATED STATEMENTS OF OPER ATIONS AND COMPREHENSIVE LOSS (UNAUDITED) Three Months Ended June 30, Six Months Ended June 30, (in thousands, except share and per share amounts) 2026 2025 2026 2025 Operating expenses: Research and development $ 25,920 $ 261,499 $ 43,515 $ 288,200 General and administrative 21,933 12,785 39,498 19,375 Total operating expenses $ 47,853 $ 274,284 $ 83,013 $ 307,575 Loss from operations ( 47,853 ) ( 274,284 ) ( 83,013 ) ( 307,575 ) Other income (expense): Interest income 4,343 537 8,278 1,342 Change in fair value of warrant liabilities ( 19,300 ) ( 1,299,922 ) ( 207,657 ) ( 1,299,922 ) Total other expense, net ( 14,957 ) ( 1,299,385 ) ( 199,379 ) ( 1,298,580 ) Net loss $ ( 62,810 ) $ ( 1,573,669 ) $ ( 282,392 ) $ ( 1,606,155 ) Net loss per share attributable to common stockholders, basic and diluted (1) $ ( 1.16 ) $ ( 251.24 ) $ ( 5.80 ) $ ( 256.88 ) Weighted-average common shares outstanding, basic and diluted (1) 54,304,456 6,263,572 48,689,196 6,252,452 Other comprehensive loss: Unrealized loss on available for sale marketable securities ( 216 ) ( 9 ) ( 963 ) ( 8 ) Total other comprehensive loss: ( 216 ) ( 9 ) ( 963 ) ( 8 ) Comprehensive loss $ ( 63,026 ) $ ( 1,573,678 ) $ ( 283,355 ) $ ( 1,606,163 ) (1) All share and per share amounts have been restated for prior periods on a retroactive basis to reflect a one-for-twenty reverse stock split effected in September 2025. See Note 2 for details. The accompanying notes are an integral part of these condensed consolidated financial statements. 2 Vor Biopharma Inc. CONDENSED CONSOLIDATED Statements of stockholders’ EQUITY (DEFICIT) (Unaudited) Common Stock (1) Additional Paid-In Accumulated other comprehensive Accumulated Total Stockholders’ (in thousands, except share amounts) Shares Amount Capital income (loss) Deficit Deficit Balance at December 31, 2025 38,720,196 $ 18 $ 988,604 $ 41 $ ( 1,152,975 ) $ ( 164,312 ) Issuance of common stock upon vesting of RSUs, net of shares withheld for taxes 352 — ( 2 ) — — ( 2 ) Issuance of common stock from private placement, net of issuance costs 5,338,078 — 74,906 — — 74,906 Stock-based compensation expense — — 8,870 — — 8,870 Issuance of common stock from exercise of pre-funded warrants 10,126,956 1 150,445 150,446 Other comprehensive loss — — — ( 747 ) — ( 747 ) Net loss — — — — ( 219,582 ) ( 219,582 ) Balance at March 31, 2026 54,185,582 $ 19 $ 1,222,823 $ ( 706 ) $ ( 1,372,557 ) $ ( 150,421 ) Issuance of common stock upon vesting of RSUs, net of shares withheld for taxes 295 — ( 2 ) — — ( 2 ) Issuance costs for private placement — — ( 14 ) — — ( 14 ) Stock-based compensation expense — — 9,399 — — 9,399 Issuance of common stock from exercise of pre-funded warrants 269,874 — 3,867 — — 3,867 Other comprehensive loss — — — ( 216 ) — ( 216 ) Net loss — — — — ( 62,810 ) ( 62,810 ) Balance at June 30, 2026 54,455,751 $ 19 $ 1,236,073 $ ( 922 ) $ ( 1,435,367 ) $ ( 200,197 ) Common Stock Additional Paid-In Accumulated other comprehensive Accumulated Total Stockholders’ (in thousands, except share amounts) Shares Amount Capital income (loss) Deficit Equity Balance at December 31, 2024 6,238,799 $ 13 $ 553,623 $ 22 $ ( 456,994 ) $ 96,664 Issuance of common stock upon vesting of RSUs, net of shares withheld for taxes, and exercise of stock options 3,769 — ( 55 ) — — ( 55 ) Issuance costs for private placement — 12 — — 12 Stock-based compensation expense — — 1,933 — — 1,933 Other comprehensive loss — — — 1 — 1 Net loss — — — — ( 32,486 ) ( 32,486 ) Balance at March 31, 2025 6,242,568 $ 13 $ 555,513 $ 23 $ ( 489,480 ) $ 66,069 Issuance of common stock upon vesting of RSUs, net of shares withheld for taxes, exercise of stock options, and issuance of common stock under ESPP 39,720 — 65 — — 65 Stock-based compensation expense — — 1,844 — — 1,844 Other comprehensive income — — — ( 9 ) — ( 9 ) Net loss — — — — ( 1,573,669 ) ( 1,573,669 ) Balance at June 30, 2025 6,282,288 $ 13 $ 557,422 $ 14 $ ( 2,063,149 ) $ ( 1,505,700 ) (1) All share and per share amounts have been restated for prior periods on a retroactive basis to reflect a one-for-twenty reverse stock split effected in September 2025. See Note 2 for details. The accompanying notes are an integral part of these condensed consolidated financial statements. 3 Vor Biopharma Inc. condensed CONSOLIDATED S tatementS of Cash Flows (unaudited) Six Months Ended June 30, (in thousands) 2026 2025 Cash flows from operating activities Net loss $ ( 282,392 ) $ ( 1,606,155 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation expense 64 2,862 Non-cash lease expense 218 5,480 Stock-based compensation 18,269 3,777 Change in fair value of warrant liabilities 207,657 1,299,922 Interest amortization on marketable securities ( 913 ) ( 22 ) Loss on sale of property and equipment — 3,303 Acquisition of in-process research and development — 222,592 Changes in operating assets and liabilities: Operating lease liabilities, net ( 123 ) ( 2,327 ) Prepaid expenses and other current assets ( 6,081 ) 2,632 Accounts payable, accrued liabilities and other current liabilities ( 296 ) ( 277 ) Other assets ( 27 ) 1,963 Net cash used in operating activities ( 63,624 ) ( 66,250 ) Cash flows from investing activities Purchases of marketable securities ( 355,500 ) — Proceeds from maturities of marketable securities 55,897 — Purchases of property and equipment ( 168 ) ( 383 ) Proceeds from sales of property and equipment — 799 Net cash (used in) provided by investing activities ( 299,771 ) 416 Cash flows from financing activities Payment of issuance costs related to private placements ( 234 ) ( 551 ) Proceeds from the issuance of pre-funded warrants — 175,000 Proceeds from exercise of pre-funded warrants 3 — Proceeds from stock option exercises and the issuance of shares under ESPP — 97 Repurchases of shares for tax withholdings upon vesting of restricted stock unit awards ( 4 ) ( 87 ) Proceeds from issuance of common stock in private placement 74,999 — Net cash provided by financing activities 74,764 174,459 Net (decrease) increase in cash, cash equivalents and restricted cash equivalents ( 288,631 ) 108,625 Cash, cash equivalents and restricted cash equivalents, beginning of period $ 396,654 $ 84,362 Cash, cash equivalents and restricted cash equivalents, end of period $ 108,023 $ 192,987 Supplemental disclosure of non-cash activities Purchases of property and equipment in accounts payable and accrued liabilities $ 12 $ — Unrealized loss on available-for-sale securities $ ( 964 ) $ — Unpaid license payments included in accounts payable and accrued expenses $ — $ 45,000 Issuance costs associated with the sale of pre-funded warrants included in accounts payable and accrued expenses $ — $ 643 A reconciliation of the cash, cash equivalents and restricted cash equivalents reported within the condensed consolidated balance sheets that sum to the total of the same amounts shown in the condensed consolidated statements of cash flows is as follows: For the Six Months Ended June 30, (in thousands) 2026 2025 Cash and cash equivalents $ 107,855 $ 190,574 Restricted cash equivalents 168 2,413 Total cash, cash equivalents and restricted cash equivalents as shown on the statements of cash flows $ 108,023 $ 192,987 The accompanying notes are an integral part of these condensed consolidated financial statements. 4 VOR BIOPHARMA INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 1. Nature of the Business Vor Biopharma Inc. (the “Company”) is a clinical-stage company advancing telitacicept, a novel, dual-target recombinant fusion protein that inhibits both BLyS (BAFF) and APRIL—two key cytokines involved in B cell survival and autoantibody production. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology. The Company is headquartered in Boston, Massachusetts. The Company was incorporated on December 30, 2015 . Risks and Uncertainties The Company is subject to a number of risks common to development stage companies in the biotechnology industry, including, but not limited to, risks of failure of clinical trials, dependence on key personnel, protection of proprietary technology, reliance on third party organizations, uncertainty of obtaining regulatory approval for any product candidate that it may develop, development by competitors of technological innovations, compliance with government regulations, adverse macroeconomic conditions and the need to obtain additional financing. Liquidity and Capital Resources The Company expects that its existing cash, cash equivalents and marketable securities as of June 30, 2026 of $ 466.1 million will be sufficient to allow the Company to fund its current planned operations through at least a period of one year after the date the financial statements are issued. As of June 30, 2026, the Company has an accumulated deficit of $ 1,435.4 million. The Company anticipates that it will continue to incur significant operating losses for the next several years as it continues to develop its product candidate. As a result, the Company's continued operations are dependent on its ability to raise additional funding. If the Company is unable to obtain additional funding on a timely basis, it may be forced to significantly curtail, delay, or discontinue one or more of its planned research or development programs or be unable to expand its operations. 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates issued by the Financial Accounting Standards Board. September 2025 Reverse Stock Split On August 25, 2025, the Company’s stockholders approved a proposal to authorize the Company’s board of directors to amend the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split. The Board approved the reverse stock split on August 27, 2025 and, on September 18, 2025, the Company effected a 1-for-20 reverse stock split of its common stock. The par value and the number of authorized shares of the common stock were not adjusted as a result of the reverse stock split. All share and per share amounts for periods prior to the effective date presented in these condensed consolidated financial statements and the notes thereto have been adjusted retroactively, where applicable, to reflect the effect of this reverse stock split. Use of Estimates The preparation of the condensed consolidated financial statements in conformity with GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the condensed consolidated financial statements and the reported amount of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies in developing the estimates and assumptions that are used in the preparation of the condensed consolidated financial statements. Management must apply significant judgment in this process. Management’s estimation process often may yield a range of potentially reasonable estimates and 5 management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, amon g others: accrued expenses and stock-based compensation expense. Unaudited Interim Financial Information The condensed consolidated financial statements of the Company included herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany transactions and balances have been eliminated in consolidation. In the opinion of management, the information furnished reflects all adjustments, all of which are of a normal and recurring nature, necessary for a fair presentation of the results for the reported interim periods. The results of operations for interim periods are not necessarily indicative of results to be expected for the full year or any other interim period. The accompanying condensed consolidated balance sheet as of December 31, 2025 has been derived from the Company’s audited consolidated financial statements for the year ended December 31, 2025. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to GAAP or the rules and regulations of the SEC. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited annual consolidated financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 (the “2025 Annual Report”). There have been no material changes to the Company’s significant accounting policies as described in the 2025 Annual Report. 3. Marketable Securities The amortized cost and estimated fair value of marketable securities, by remaining contractual maturity, are as follows: June 30, 2026 (in thousands) Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value Maturing in one year or less Corporate bonds $ 64,673 — $ ( 190 ) $ 64,483 Commercial paper 8,424 — — 8,424 Yankee bonds 2,510 — ( 15 ) 2,495 U.S. Treasuries 131,087 — ( 252 ) 130,835 U.S. Treasury bills 45,913 — ( 5 ) 45,908 Maturing after one year through five years Corporate bonds 48,200 — ( 245 ) 47,955 U.S. Treasuries 58,389 — ( 215 ) 58,174 Total $ 359,196 $ — $ ( 922 ) $ 358,274 December 31, 2025 (in thousands) Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Fair Value Maturing in one year or less U.S. Treasuries $ 25,772 $ 16 $ — $ 25,788 U.S. Treasury bills 13,636 6 — 13,642 Maturing after one year through five years U.S. Treasuries 19,273 19 — 19,292 Total $ 58,681 $ 41 $ — $ 58,722 The following table presents the fair value of the Company’s securities that were in an unrealized loss position as of June 30, 2026, and the total unrealized loss by each type of security. The Co mpany did no t record any impairments to marketable securities or reserves for credit losses related to its marketable debt securities during the periods presented. There were no securities in an unrealized loss position as of December 31, 2025. 6 June 30, 2026 Less than twelve months Greater than twelve months Total (in thousands) Fair value Unrealized loss Fair value Unrealized loss Fair value Unrealized loss Corporate bonds $ 112,438 $ ( 435 ) — — $ 112,438 $ ( 435 ) Commercial paper 8,424 — — — 8,424 — U.S. Treasury bills 45,908 ( 5 ) — — 45,908 ( 5 ) U.S. Treasuries 189,009 ( 467 ) — — 189,009 ( 467 ) Yankee bonds 2,495 ( 15 ) — — 2,495 ( 15 ) Total $ 358,274 $ ( 922 ) $ — $ — $ 358,274 $ ( 922 ) 4. Fair Value Measurements The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis: June 30, 2026 (in thousands) Level 1 Level 2 Level 3 Total Cash equivalents Money market funds $ 106,896 $ — $ — $ 106,896 Total cash equivalents 106,896 — — 106,896 Marketable securities Corporate bonds — 112,438 — 112,438 Commercial paper — 8,424 — 8,424 U.S. Treasury bills — 45,908 — 45,908 U.S. Treasuries — 189,009 — 189,009 Yankee bonds — 2,495 — 2,495 Total marketable securities — 358,274 — 358,274 Restricted cash equivalents Money market funds 168 — — 168 Liabilities Warrant liabilities — 653,894 — 653,894 December 31, 2025 (in thousands) Level 1 Level 2 Level 3 Total Cash equivalents Money market funds $ 392,803 $ — $ — $ 392,803 U.S. Treasury bills — 3,434 — 3,434 Total cash equivalents 392,803 3,434 — 396,237 Marketable securities U.S. Treasury bills — 13,642 — 13,642 U.S. Treasuries — 45,080 — 45,080 Total marketable securities — 58,722 — 58,722 Restricted cash equivalents Money market funds 168 — — 168 Liabilities Warrant liabilities — 600,547 — 600,547 The fair value of the Company’s cash equivalents and restricted cash equivalents is determined based on quoted market prices in active markets with no valuation adjustment. The fair value of marketable securities and warrant liabilities is determined based o n observable market inputs. There were no transfers between levels during the six months ended June 30, 2026. Prepaid expenses, accounts payable and accrued expenses are stated at their respective historical carrying values, which approximate fair value due to their short-term nature. 7 5. Property and Equipment, Net Property and equipment, net consisted of the following: June 30, December 31, (in thousands) 2026 2025 Furniture, fixtures and other 738 558 Total 738 558 Less: Accumulated depreciation ( 90 ) ( 25 ) Property and equipment, net $ 648 $ 533 An immaterial amount of depreciation was recognized during the three and six months ended June 30, 2026. Depreciation expense for the three and six months ended June 30, 2025 was $ 2.1 and $ 2.9 million, respectively. 6. Accrued Liabilities Accrued liabilities consisted of the following: June 30, December 31, (in thousands) 2026 2025 Employee-related expenses $ 4,719 $ 3,066 Professional fees 1,141 1,366 Clinical expenses 9,418 8,466 Manufacturing expenses 3,945 6,071 Other research and development expenses 941 241 Other 317 554 Total accrued liabilities $ 20,481 $ 19,764 7. Stockholders' Equity and Warrants 2024 Private Placement On December 27, 2024, the Company entered into a purchase agreement with certain institutional investors (collectively, the “2024 Purchasers”), pursuant to which the Company issued and sold to the 2024 Purchasers in a private placement an aggregate of (i) 2,793,562 shares of the Company's common stock and (ii) warrants to purchase up to 3,491,953 shares of the Company's common stock (the “2024 Warrants”) at the closing of the private placement on December 30, 2024. Net proceeds from the private placement were $ 52.7 million, after deducting placement fees and issuance costs payable by the Company. The 2024 Warrants have an exercise price of $ 16.76 per share and are immediately exercisable, subject to certain limitations on exercise set forth in the 2024 Warrants. The 2024 Warrants will terminate seven years from issuance on December 30, 2031 . The Company determined that the 2024 Warrants are freestanding instruments that do not meet the definition of a liability or derivative. The 2024 Warrants are indexed to the Company’s common stock and meet all other conditions for equity classification. Accordingly, the 2024 Warrants were classified as equity and accounted for as a component of additional paid-in capital at the time issued. The Company also determined that the 2024 Warrants should be included in the determination of diluted net loss per share if their impact is dilutive. However, they are not included within diluted net loss per share for the three and six months ended June 30, 2026 or 2025 as their effect would be antidilutive. As of June 30, 2026 , no ne of the 2024 Warrants have been exercised. June 2025 Private Placement On June 25, 2025, the Company entered into a purchase agreement with certain institutional investors (collectively, the “2025 Purchasers”), pursuant to which the Company issued and sold to the 2025 Purchasers in a private placement warrants to purchase up to an aggregate of 34,999,999 shares of the Company’s common stock (the “2025 PIPE Warrants”) at the closing on June 27, 2025. Net proceeds from the private placement were $ 174.4 million, after deducting issuance costs payable by the Company. In addition to the 2025 PIPE Warrants, on June 25, 2025 the Company issued a warrant to purchase up to 16,000,000 shares of the Company’s common stock as partial consideration for the Telitacicept License Agreement (as defined below) to a subsidiary of RemeGen Co., Ltd. 8 (“RemeGen Warrant”). Refer to Note 10 for additional information on the license arrangement. The 2025 PIPE Warrants and RemeGen Warrant are collectively referred to as the 2025 Warrants. The 2025 Warrants have an exercise price of $ 0.002 per share and became ex ercisable upon stockholder approval of the issuance of the underlying shares and an amendment to the certificate of incorporation to increase the number of authorized shares, subject to certain limitations on exercise set forth in the 2025 Warrants. On August 25, 2025, the stockholders approved the issuance of the underlying shares and on September 17, 2025, the Company filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to effect a reverse stock split, resulting in sufficient available authorized shares for warrant holders to exercise the 2025 Warrants. The 2025 Warrants do not expire. Upon issuance, the 2025 Warrants were liability-classified as they are not considered indexed to the Company’s common stock. The 2025 Warrants are measured at fair value each period with changes in fair value presented within the condensed consolidated statements of operations and comprehensive loss. The valuation of the 2025 Warrants is classified within Level 2 of the fair value hierarchy due to the use of observable market inputs, primarily the quoted price of the Company’s common stock underlying the warrants. The initial carrying value of the 2025 PIPE Warrants and the RemeGen Warrant at issuance was $ 175.0 million and $ 177.4 million, respectively. Issuance costs related to the 2025 PIPE Warrants were expensed as incurred. The Company also determined the 2025 Warrants should be included in the determination of diluted net loss per share if their impact is dilutive. However, they are not included within diluted net loss per share for the three and six months ended June 30, 2026 and 2025 as the effect would be antidilutive. During the three and six months ended June 30, 2026 , 269,912 and 10,398,099 , respectively, of the 2025 Warrants were exercised for an immaterial amount of net proceeds. Some of the exercises were completed via cashless exercise, which resulted in slightly less shares issued than warrants exercised for such transactions. The remaining 35,522,260 outstanding 2025 Warrants had a fair value of $ 653.9 million as of June 30, 2026. November 2025 Public Offering On November 10, 2025, the Company entered into an underwriting agreement relating to the issuance and sale in a public offering of 11,500,000 shares of the Company’s common stock, including 1,500,000 shares purchased by the underwriters under a 30-day option to purchase additional shares (the “November 2025 Offering”) at a public offering price of $ 10.00 per share. The net proceeds to the Company from the November 2025 Offering were $ 107.7 million after deducting the underwriting discounts and commissions and offering expenses. December 2025 Private Placement On December 15, 2025, the Company entered into a securities purchase agreement with certain investors pursuant to which the Company, in a private placement, issued and sold an aggregate of 13,876,032 shares of common stock, at a price per share of $ 10.81 , for net proceeds of $ 149.9 million after deducting offering expenses (the “December 2025 Private Placement”). March 2026 Private Placement On March 26, 2026 the Company entered into a securities purchase agreement with entities affiliated with TCG Crossover Management, LLC (“TCGX”) pursuant to which the Company, in a private placement, issued and sold an aggregate of 5,338,078 shares of common stock, at a price per share of $ 14.05 , for net proceeds of $ 74.9 million after deducting offering expenses (the “March 2026 Private Placement”). The private placement closed on March 30, 2026. 8. Stock-Based Compensation 2023 Inducement Plan As of June 30, 2026, the Company had 2,274,893 shares of its common stock available for future issuance under the 2023 Inducement Plan. Amended and Restated 2021 Equity Incentive Plan As of June 30, 2026, the Company had 517,674 shares of its common stock available for future issuance under its Amended and Restated 2021 Equity Incentive Plan. 9 Stock Options The Company’s stock options generally vest ratably over a four-year period and have a contractual term of ten years . The weighted-average assumptions used principally in determining the fair value of new options granted during the periods presented were as follows: Six months ended June 30, 2026 2025 Expected term (in years) 6.0 6.1 Expected volatility 101.8 % 98.9 % Risk-free interest rate 4.0 % 3.9 % Dividend yield — — During the six months ended June 30, 2026 and 2025, the Company granted new stock options to purchase 972,425 shares and 4,377,494 shares of its common stock, respectively, with a weighted-average grant-date fair value of $ 11.65 and $ 14.60 per share, respectively. A s of June 30, 2026, total unrecognized compensation expense related to stock options was $ 107.3 million , which is expected to be recognized over a weighted-average period of 3.1 years. There were no stock options exercised during the six months ended June 30, 2026. There were 7,545,245 options outstanding as of June 30, 2026. Restricted Stock Units During the six months ended June 30, 2026 and 2025, the Company granted 194,715 and 61,200 restricted stock units, respectively, with a weighted-average grant date fair value of $ 14.90 and $ 26.60 per share, respectively. As of June 30, 2026, total unrecognized compensation expense related to restricted stock units was $ 7.6 million , which is expected to be recognized over a weighted-average period of 3.4 years. There were 373,811 unvested restricted stock units as of June 30, 2026. Employee Stock Purchase Plan As of June 30, 2026, the Company had 205,932 shares of its common stock available for issuance under its Employee Stock Purchase Plan (“ESPP”). The Company did no t issue any shares of common stock under the ESPP during the six months ended June 30, 2026. The Company issued 33,494 shares with a weighted-average exercise price of $ 3 under the ESPP during the six months ended June 30, 2025. Performance Stock Units During the six months ended June 30, 2026, the Company granted a total of 604,285 Performance Stock Units (“PSUs”) with an initial fair value of $ 14.09 to certain members of the Company’s management team. Vesting of the PSUs is contingent upon meeting certain performance conditions as well as meeting certain service conditions. The total initial expense of $ 8.5 million for these awards is expected to be recognized through June 2029, depending on the achievement of the related performance conditions. Stock-Based Compensation Stock-based compensation expense was allocated as follows: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2026 2025 2026 2025 Research and development $ 814 $ 599 $ 1,414 $ 1,641 General and administrative 8,585 1,245 16,855 2,136 Total stock-based compensation expense $ 9,399 $ 1,844 $ 18,269 $ 3,777 9. Leases Boylston Lease In August 2025, the Company entered into a lease agreement for office space (“Boylston Lease”) with 500 Boylston & 222 Berkeley Owner (DE) LLC (the “Boylston Landlord”). The commencement date of the lease was September 1, 2025 , and the Boylston Lease will expire on August 31, 2031 , unless terminated earlier in accordance with the lease agreement. The Company has the option to extend the term for one additional five-year period . 10 Payments due associated with the Boylston Lease include both fixed and variable payments. Total fixed lease payments under the lease agreement are $ 3.8 million. Variable payments relate to the Company’s share of the Boylston Landlord’s operating costs associated with the underlying assets and are recognized when the event on which those payments are assessed occurs. The Boylston Lease does not contain a residual value guarantee. In conjunction with the Boylston Lease, the Company was required to execute an irrevocable standby letter of credit of $ 0.2 million for the benefit of the Boylston Landlord. As of June 30, 2026, the funds securing the letter of credit were presented as restricted cash equivalents on the condensed consolidated balance sheets. The elements of lease expense were as follows: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2026 2025 2026 2025 Operating lease cost $ 158 $ 13,085 $ 316 $ 15,036 Variable lease cost 67 774 126 1,485 Total lease cost $ 225 $ 13,859 $ 442 $ 16,521 During the three and six months ended June 30, 2025, the Company entered into an early termination agreement with the landlord of its previously leased office space on June 20, 2025, pursuant to which the parties agreed to terminate the lease, effective August 4, 2025. Per the terms of such agreement, the Company made a non-refundable termination payment in the amount of $ 8.5 million to the previous landlord. The early termination was treated as a lease modification for accounting purposes. As a result of the modification, the Company remeasured the lease liability and recognized a corresponding adjustment to the right-of-use asset as of the date of the modification. Additionally, as of June 30, 2025, the space was determined to be abandoned, thus the Company accelerated amortization of the right of-use asset and de-recognized any remaining balances during the period. The total expense recognized in the three and six months ended June 30, 2025 in connection with the termination of the lease in those periods was $ 11.2 million. Amounts reported in the condensed consolidated balance sheets and the weighted-average lease term and discount rate information were as follows: (in thousands except weighted-average amounts) June 30, 2026 December 31, 2025 Assets Operating lease right-of-use assets $ 2,718 $ 2,936 Liabilities Operating lease liabilities, current $ 335 $ 280 Operating lease liabilities, non-current 2,542 2,720 Total lease liabilities $ 2,877 $ 3,000 Weighted-Average Lease Term and Discount Rate Weighted-average remaining lease term (years) 5.2 5.7 Weighted-average discount rate 6.7 % 6.7 % The following table represents other lease activity: Three months ended Six months ended (in thousands) 2026 2025 2026 2025 Other Information Cash paid for amounts included in the measurement of lease liabilities Operating cash flows for operating leases $ 110 $ 10,196 $ 220 $ 11,884 10. Significant Agreements Telitacicept License Agreement On June 25, 2025, the Company and RemeGen Co., Ltd. (“RemeGen”) entered into a license agreement (the “Telitacicept License Agreement”) granting the Company exclusive rights to develop and commercialize RemeGen’s proprietary fusion protein compound, telitacicept (the “Licensed Compound”), outside of the People’s Republic of China, Hong Kong, Macau and Taiwan 11 (collectively, “Greater China”). RemeGen retains all rights to the Licensed Compound in Greater China. Under the License Agreement, the Company received an exclusive (even as to RemeGen) license under RemeGen’s patents and know-how to exploit, develop and commercialize the Licensed Compound in all territories other than Greater China, with the right to grant sublicenses. The Company also received a non-exclusive license to manufacture the Licensed Compound and any resulting licensed products (“Licensed Products”) worldwide solely for use in the licensed territory. The Company is responsible for all development, regulatory and commercialization activities and costs in the licensed territory, including the conduct of clinical trials and regulatory submissions. The Telitacicept License Agreement established a joint steering committee (“JSC”) to oversee the ongoing development and commercialization of telitacicept. The JSC comprises an equal number of senior-level executives from each party; however, final decision-making authority as it relates to the development and commercialization of the Licensed Compound outside Greater China lies with the Company. As consideration for the rights granted, the Company agreed to make an upfront cash payment in the amount of $ 45.0 million and issued the RemeGen Warrant to a subsidiary of RemeGen, which was initially valued at $ 177.4 million. Refer to Note 7 for details on the terms of the RemeGen Warrant. The $ 45.0 million cash payment due to RemeGen was paid during the year ended December 31, 2025. The Company incurred $ 0.2 million in transaction costs related to the Telitacicept License Agreement during the year ended December 31, 2025. The Company accounted for the Telitacicept License Agreement as an asset acquisition as substantially all of the value received was concentrated in the Licensed Compound which does not have an alternate future use as it is not yet approved for commercial sale in the licensed territory. Accordingly, the Company recognized a $ 222.6 million charge to research and development expense on the condensed consolidated statement of operations and comprehensive loss during the year ended December 31, 2025 associated with this asset acquisition. The Company’s accounting policy is to classify the cost of asset acquisitions as an operating cash outflow on the condensed consolidated statement of cash flows. Pursuant to the terms of the Telitacicept License Agreement, RemeGen is eligible to receive up to $ 330 million in regulatory milestone payments and up to $ 3.775 billion in sales milestone payments. In addition, RemeGen is entitled to receive tiered royalties on net sales of the Licensed Products in the licensed territory, ranging from high single digit to mid-teen percentages of net sales, subject to customary reductions. If the Company enters into a sublicense or divests rights to the Licensed Products prior to a specified development event and other than in connection with a change of control, RemeGen is entitled to receive a single digit percentage of certain net proceeds from such transactions. The Telitacicept License Agreement also provides for technology transfer, mutual indemnification and confidentiality. As of June 30, 2026, no milestone or royalty payments have been accrued for as the consideration is not yet payable per the terms of the Agreement. The Telitacicept License Agreement may be terminated, in its entirety or on a region-by-region basis, by either party for material breach (subject to cure periods and dispute resolution) or insolvency of the other party, by the Company for convenience with advance notice, or by RemeGen if the Company challenges the validity of licensed patents. Upon termination, all rights and licenses in the terminated region will revert to RemeGen, with a wind-down period for the Company to cease activities. 11. Net Loss Per Share The following table sets forth the computation of the Company’s basic and diluted net loss per share for the three and six months ended June 30, 2026 and 2025: Three Months Ended June 30, Six Months Ended June 30, (in thousands, except share and per share amounts) 2026 2025 2026 2025 Numerator: Net loss attributable to common stockholders $ ( 62,810 ) $ ( 1,573,669 ) $ ( 282,392 ) $ ( 1,606,155 ) Denominator: Weighted-average number of common shares outstanding, basic and diluted 54,304,456 6,263,572 48,689,196 6,252,452 Net loss per share attributable to common stockholders, basic and diluted $ ( 1.16 ) $ ( 251.24 ) $ ( 5.80 ) $ ( 256.88 ) The Company’s potentially dilutive securities were stock options, restricted stock units, warrants, and performance stock units. Based on the amounts outstanding as of June 30, 2026 and 2025, the Company excluded the following potential common shares from the computation of diluted net loss per share attributable to common stockholders because including them would have had an anti-dilutive effect: 12 As of June 30, 2026 2025 Options to purchase common stock 7,545,245 4,731,052 Restricted stock units 373,811 96,432 Performance stock units 604,285 — Warrants 39,014,213 54,491,952 12. Segments The Company operates and manages its business as one reportable and operating segment, centered around the commercial development of its product candidates. The Company’s chief operating decision maker (“CODM”) is the Chief Executive Officer . The Company’s CODM reviews consolidated operating results, manages the business on a consolidated basis and utilizes consolidated net loss from the condensed consolidated statements of operations and comprehensive loss to make decisions about allocating resources and assessing performance for the entire Company. Consolidated net loss is also used to monitor budget to actual results. The CODM is additionally regularly provided with more detailed expense information at the program level. The following table is a summary of the segment profit or loss, including significant segment expenses: Three Months Ended June 30, Six Months Ended June 30, (in thousands) 2026 2025 2026 2025 Segment expenses: Telitacicept - gMG (a) $ 12,152 $ — $ 21,945 $ — Telitacicept - SjD (a) 6,331 — 8,830 — Trem-cel (a) — 3,095 250 9,477 VCAR33 (a) — 2,419 73 6,055 Other research and development (a) 1,902 225,144 2,680 228,139 Salaries and benefits 9,787 17,863 17,342 29,476 General corporate activities 8,235 16,694 13,209 21,863 Other segment items (b) 24,403 1,308,454 218,063 1,311,145 Segment expenses: 62,810 1,573,669 282,392 1,606,155 Segment net loss $ ( 62,810 ) $ ( 1,573,669 ) $ ( 282,392 ) $ ( 1,606,155 ) (a) Includes only external research and development expenditures. (b) Other segment items are primarily comprised of interest income on marketable securities and certain non-cash expenses such as change in fair value of warrant liabilities, stock-based compensation, and depreciation expense. The measure of segment assets is reported on the condensed consolidated balance sheets as total assets. The CODM additionally reviews cash, cash equivalents and marketable securities when reviewing segment assets. As of June 30, 2026, the Company’s cash, cash equivalents and marketable securities were $ 466.1 million. The Company does not provide its CODM with any more detailed segment asset information than what is included on the Company’s condensed consolidated balance sheets. 13. Related Party Transactions March 2026 Private Placement As discussed in Note 7, on March 26, 2026, the Company entered into a securities purchase agreement with entities affiliated with TCGX pursuant to which the Company issued and sold an aggregate of 5,338,078 shares of common stock, at a price per share of $ 14.05 , for net proceeds of $ 74.9 million after deducting offering expenses. Upon the execution of the March 2026 Private Placement on March 30, 2026, TCGX became a greater than 10 % owner of the Company’s common stock and therefore became a principal owner in accordance with ASC 850, Related Party Transactions . 13 14. Subsequent Events At-the-Market Sales Activity During July 2026, the Company sold 2,558,569 shares of common stock under the existing at-the-market sales agreement with Stifel, Nicolaus & Company, Incorporated as the agent (the "Stifel ATM Facility"). The shares were sold at a weighted-average price per share of $ 19.11 for aggregate gross proceeds of $ 48.9 millio n, before deducting commissions of $ 0.5 million. Following these sales, there is no remaining capacity under the current prospectus supplement associated with the Stifel ATM Facility. 2025 Warrant Exercise In July 2026, 2,100,000 of the 2025 Warrants were exercised on a cashless basis by RA Capital Healthcare Fund, L.P. (“RA Capital”) in exchange for 2,099,787 shares of common stock. RA Capital was a related party to the Company under ASC 850 through the reporting date of June 30, 2026. 14 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 the unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and with the consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2025 (the “2025 Annual Report”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the section titled “Risk Factors” in our 2025 Annual Report and in other reports we have filed or may file with the SEC, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Overview Vor Bio is a clinical-stage biopharmaceutical company focused on developing a novel therapy in the treatment of autoimmune diseases. In June 2025, we in-licensed telitacicept from RemeGen Co., Ltd. (“RemeGen”). Pursuant to our license agreement with RemeGen, we were granted an exclusive license to develop and commercialize telitacicept outside of the Greater China region, which includes mainland China, Hong Kong, Macau and Taiwan. RemeGen retains development and commercialization rights in Greater China. Telitacicept is approved in China for the treatment of generalized myasthenia gravis (“gMG”), systemic lupus erythematosus (“SLE”), rheumatoid arthritis (“RA”), Sjögren’s disease (“SjD”) and IgA nephropathy (“IgAN”). Telitacicept is currently being evaluated for the treatment of gMG in a global Phase 3 clinical trial, for which we have assumed responsibility from RemeGen in connection with the license agreement. The trial is currently recruiting patients in North America, Europe, Latin America, and Asia to support potential approval in the United States, Europe, Japan and other countries. In July 2024, the clinical trial enrolled a patient in the United States, the first in the global clinical trial. Topline data from the trial is anticipated in the first half of 2027. Telitacicept was evaluated by RemeGen in a Phase 3 clinical trial in patients with gMG in China. Most recently, the 48-week data from Part B of the Phase 3 trial were presented at the American Association of Neuromuscular & Electrodiagnostic Medicine (“AANEM”) Annual Meeting in October 2025. We are also evaluating telitacicept in a global Phase 3 clinical trial for the treatment of SjD. The first patient in this trial was dosed in March 2026, and we expect to recruit a total of approximately 250 adults with SjD in the United States, Europe, South America, and Asia. The trial is a randomized, double-blind, placebo-controlled trial. Telitacicept was evaluated by RemeGen in a Phase 3 clinical trial in patients with active SjD in China. Most recently, the 48-week data including Stage A and B from the Phase 3 trial were presented at the American College of Rheumatology (“ACR”) Annual Meeting in October 2025. We have incurred significant operating losses since inception, including net losses of $62.8 million and $1,573.7 million for the three months ended June 30, 2026 and 2025, respectively, and $282.4 million and $1,606.2 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $1,435.4 million. As of June 30, 2026, we had cash, cash equivalents and marketable securities of $466.1 million. Additionally, we have received gross proceeds of $48.9 million, before deducting commissions of $0.5 million, from sales of shares of our common stock subsequent to June 30, 2026 transacted through our At-the-Market sales agreement, as described in the Liquidity and Capital Resources section below. Based on our current operating plan, we expect that our cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements into early 2029. Critical Accounting Estimates Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles. The preparation of our condensed consolidated financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, costs, and expenses, and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts, and experience. The effects of material revisions in estimates, if any, will be reflected in the condensed consolidated financial statements 15 prospectively from the date of change in estimates. There have been no changes to our critical accounting estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2025 Annual Report. Financial Operations Overview Revenue We have not generated any revenue since our inception and do not expect to generate any revenue from the sale of products in the near future, if at all. If our development efforts for our current or future product candidates are successful and result in marketing approval, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from such agreements. Expenses Research and Development Expenses Research and development expenses consist primarily of external and internal expenses incurred in connection with our research and development activities, including our drug discovery efforts and the development of our product candidates. External expenses include: • research and development expenses incurred under agreements with clinical research organizations (“CROs”) and other scientific development services; • costs of consultants, including their fees and related travel expenses; • costs related to compliance with quality and regulatory requirements; • costs of laboratory supplies and acquiring and developing preclinical and clinical trial materials, including expenses associated with our clinical manufacturing organizations (“CMOs”); and • payments made and consideration issued under third party licensing agreements. Internal expenses include: • personnel-related expenses, including salaries, bonuses, benefits and stock-based compensation expenses, for employees involved in research and development activities; and • facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent, insurance, and other internal operating costs. We expense research and development costs as incurred. We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our condensed consolidated financial statements as prepaid expenses or accrued research and development expenses. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized, even when there is no alternative future use for the research and development. The capitalized amounts are expensed as the related goods are delivered or the services are performed. A significant portion of our research and development costs have been external costs, which we track by program. Research and development activities are central to our business model. We expect that our research and development expenses will increase significantly for the foreseeable future as we continue to identify and develop product candidates, particularly as our product candidate continues through the later stages of clinical development. The successful development of our product candidates in the future is highly uncertain. Therefore, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development and commercialization of any of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from the sale of our product candidates, if approved. This is due to the numerous risks and uncertainties associated with developing product candidates, many of which are outside of our control, including the uncertainty of: • the timing and progress of clinical development activities; • the number and scope of clinical programs we decide to pursue; • our ability to maintain our current research and development programs and to establish new ones; • establishing an appropriate safety profile with IND-enabling studies; • the number of sites and patients included in the clinical trials; 16 • the countries in which the clinical trials are conducted; • per patient trial costs; • successful patient enrollment in, and the initiation of, clinical trials, as well as drop out or discontinuation rates; • the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority; • the number of trials required for regulatory approval; • the timing, receipt and terms of any regulatory approvals from applicable regulatory authorities; • our ability to establish new licensing or collaboration arrangements; • the performance of our current and future collaborators, if any; • establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; • significant and changing government regulation and regulatory guidance; • the impact of any business interruptions to our operations or to those of the third parties with whom we work; • obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights; • launching commercial sales of our product candidates, if approved, whether alone or in collaboration with others; and • maintaining a continued acceptable safety profile of the product candidates following approval. Any changes in the outcome of any of these variables could mean a significant change in the costs and timing associated with the development of our product candidates. General and Administrative Expenses General and administrative expenses consist primarily of personnel-related costs, including salaries, bonuses, benefits and stock-based compensation expenses for employees involved in our executive, finance, corporate, business development and administrative functions, as well as expenses for outside professional services, including legal, audit, accounting and tax-related services and other consulting fees, facility-related expenses, which include depreciation costs and other allocated expenses for rent and maintenance of facilities, insurance costs, recruiting costs, travel expenses and other general administrative expenses. We expect that our general and administrative expenses will increase as our business expands and we hire additional personnel to support our continued development of our clinical programs. We also anticipate continued increased expenses associated with being a public company, including costs for legal, audit, accounting, investor and public relations, regulatory and tax-related services related to compliance with the rules and regulations of the SEC, Nasdaq listing standards and director and officer insurance premiums. Other Income (Expense), net Interest Income Interest income consists of interest income earned on our cash, cash equivalents and marketable securities held in financial institutions. Change in Fair Value of Warrant Liabilities Change in fair value of warrant liabilities represents the change in the fair value of liability-classified warrants due to changes in their intrinsic value resulting from changes in the quoted price of the Company’s common stock underlying the warrants. 17 Results of Operations Comparison of three months ended June 30, 2026 and 2025 The following table summarizes our results of operations for the periods indicated (amounts in thousands): Three Months Ended June 30, 2026 2025 Change Operating expenses: Research and development $ 25,920 $ 261,499 $ (235,579 ) General and administrative 21,933 12,785 9,148 Total operating expenses 47,853 274,284 (226,431 ) Loss from operations (47,853 ) (274,284 ) 226,431 Other income (expense): Interest income 4,343 537 3,806 Change in fair value of warrant liabilities (19,300 ) (1,299,922 ) 1,280,622 Total other expense, net (14,957 ) (1,299,385 ) 1,284,428 Net loss $ (62,810 ) $ (1,573,669 ) $ 1,510,859 Research and Development Expenses The following table summarizes our research and development expenses incurred for the periods indicated (amounts in thousands): Three Months Ended June 30, 2026 2025 Change External research expenses: Telitacicept - gMG $ 12,152 $ — $ 12,152 Telitacicept - SjD 6,331 — 6,331 Trem-cel — 3,095 (3,095 ) VCAR33 — 2,419 (2,419 ) Other research and development 1,902 225,144 (223,242 ) Internal research expenses: Salaries and benefits 4,608 11,742 (7,134 ) Stock-based compensation 814 599 215 Manufacturing, facilities, and other research expenses 113 18,500 (18,387 ) Total research and development expenses $ 25,920 $ 261,499 $ (235,579 ) Research and development expenses were $25.9 million for the three months ended June 30, 2026, compared to $261.5 million for the three months ended June 30, 2025. The decrease of $235.6 million was primarily due to the $222.6 million of expense recognized in connection with the upfront consideration for the Telitacicept License Agreement in the three months ended June 30, 2025. There were also decreases of $18.4 million in manufacturing, facilities, and other expenses primarily driven by the acceleration of amortization and terminated lease fees incurred in connection with the termination of the lease in the three months ended June 30, 2025. There was also a decrease of $7.1 million in salaries and benefits expenses primarily due to severance costs incurred in connection with employee terminations in the prior year period. The decreases were also due to decreases in spend for Trem-cel and VCAR33 of $3.1 and $2.4 million, respectively, compared to the prior year period. These decreases were partially offset by a $18.5 million increase in spend for our new programs, telitacicept - gMG and telitacicept - SjD. General and Administrative Expenses General and administrative expenses were $21.9 million for the three months ended June 30, 2026, compared to $12.8 million for the three months ended June 30, 2025. The increase of $9.1 million was primarily due to a $7.3 million increase in stock-based compensation expense, a $3.3 million increase in commercial-related expenses, and a $0.7 million increase in professional fees. The increases were partially offset by a $0.8 million decrease in personnel-related expenses and a $1.4 million decrease in facilities and other expenses. The increase in stock-based compensation was primarily driven by grants to new members of our management team hired in the second and third quarters of 2025, as well as an appreciation in our stock price and incremental expense recognized from award modifications which took place at the end of the year ended December 31, 2025. The increase in commercial-related expenses 18 was due primarily to an increase in commercial activities as the Company prepares for potential commercial launch as its clinical trials progress. Other Expense, Net Other expense, net decreased by $1,284.4 million during the three months ended June 30, 2026, compared to the three months ended June 30, 2025. The decrease in other expense was primarily due to the change in fair value of the warrant liabilities resulting from changes in the quoted price of the Company’s common stock underlying the warrants, and a decrease in warrants outstanding compared to the prior year period. Comparison of six months ended June 30, 2026 and 2025 The following table summarizes our results of operations for the periods indicated (amounts in thousands): Six Months Ended June 30, 2026 2025 Change Operating expenses: Research and development $ 43,515 $ 288,200 $ (244,685 ) General and administrative 39,498 19,375 20,123 Total operating expenses 83,013 307,575 (224,562 ) Loss from operations (83,013 ) (307,575 ) 224,562 Other income (expense): Interest income 8,278 1,342 6,936 Change in fair value of warrant liabilities (207,657 ) (1,299,922 ) 1,092,265 Total other expense, net (199,379 ) (1,298,580 ) 1,099,201 Net loss $ (282,392 ) $ (1,606,155 ) $ 1,323,763 Research and Development Expenses The following table summarizes our research and development expenses incurred for the periods indicated (amounts in thousands): Six Months Ended June 30, 2026 2025 Change External research expenses: Telitacicept - gMG $ 21,945 $ — $ 21,945 Telitacicept - SjD 8,830 — 8,830 Trem-cel 250 9,477 (9,227 ) VCAR33 73 6,055 (5,982 ) Other research and development 2,680 228,139 (225,459 ) Internal research expenses: Salaries and benefits 8,105 20,799 (12,694 ) Stock-based compensation 1,414 1,641 (227 ) Manufacturing, facilities, and other research expenses 218 22,089 (21,871 ) Total research and development expenses $ 43,515 $ 288,200 $ (244,685 ) Research and development expenses were $43.5 million for the six months ended June 30, 2026, compared to $288.2 million for the six months ended June 30, 2025. The decrease of $244.7 million was primarily due the $222.6 million of expense recognized in connection with the upfront consideration for the Telitacicept License Agreement in the six months ended June 30, 2025. There were also decreases of $21.9 million in manufacturing, facilities, and other expenses primarily driven by the acceleration of amortization and terminated lease fees incurred in connection with the termination of the lease in the six months ended June 30, 2025. There was also a decrease of $12.7 million in salaries and benefits expenses primarily due to severance costs incurred in connection with employee terminations in the prior year period, and also due in part to a decreased headcount compared to the prior year period. The decreases were also due to decreases in spend for Trem-cel and VCAR33 of $9.2 and $6.0 million, respectively, compared to the prior year period, as well as a $0.2 million decrease in stock-based compensation. These decreases were partially offset by a $30.8 million increase in spend for our new programs, telitacicept - gMG and telitacicept - SjD. 19 General and Administrative Expenses General and administrative expenses were $39.5 million for the six months ended June 30, 2026 , compared to $19.4 million for the six months ended June 30, 2025. The increase of $20.1 million was primarily due to a $14.7 million increase in stock-based compensation expense, a $4.5 million increase in commercial-related expenses, a $1.6 million increase in professional fees, and a $0.6 million increase in personnel-related expenses. The increases were partially offset by a $1.4 million decrease in facilities and other expense. The increase in stock-based compensation was primarily driven by grants to new members of our management team hired in the second and third quarters of 2025, as well as an appreciation in our stock price and incremental expense recognized from award modifications which took place at the end of the year ended December 31, 2025. The increase in commercial-related expenses was due primarily to an increase in commercial activities as the Company prepares for potential commercial launch as its clinical trials progress. Other Expense, net Other income expense decreased by $1,099.2 million during the six months ended June 30, 2026, compared to the six months ended June 30, 2025. The decrease in other expense was primarily due to the change in fair value of the warrant liabilities resulting from changes in the quoted price of the Company’s common stock underlying the warrants, and a decrease in warrants outstanding compared to the prior year period. Liquidity and Capital Resources Sources of Liquidity Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. We have funded our operations primarily through the sale of equity securities and have received aggregate net proceeds from these transactions of approximately $1,094.1 million as of June 30, 2026. In order to fund our future operations, including our ongoing and planned clinical trials, we filed a universal shelf registration statement, which was declared effective on March 31, 2025, to provide for aggregate offerings of up to $350.0 million of common stock, preferred stock, debt securities, warrants or any combination thereof. As of June 30, 2026, $164.2 million remained available under this Shelf Registration Statement, including $48.9 million reserved for at-the-market offerings discussed below. At-the-Market Sales Agreements In December 2022, we entered into a Sales Agreement with Stifel, Nicolaus & Company, Incorporated (“Stifel”) as the agent (the "Stifel ATM Facility"). Pursuant to the Stifel ATM Facility, we may offer and sell shares of common stock with an aggregate value of up to $125.0 million. We pay Stifel a commission of up to 3.0% of the gross proceeds of any common stock sold through Stifel. We did not sell any shares of our common stock under the Stifel ATM Facility during the six months ended June 30, 2026. As of June 30, 2026, $48.9 million remained available to be sold under the Stifel ATM Facility. Subsequent to June 30, 2026, we have sold 2,558,569 shares for gross proceeds of $48.9 million, before deducting commissions of $0.5 million, at a weighted-average price of $19.11 under the Stifel ATM facility. March 2026 Private Placement On March 26, 2026, we entered into a purchase agreement with institutional investors pursuant to which we agreed to issue and sell an aggregate of 5,338,078 shares of common stock, at a price per share of $14.05, for net proceeds of $74.9 million after deducting offering expenses payable by us. The private placement closed on March 30, 2026. Cash Requirements As of June 30, 2026, we had cash, cash equivalents and marketable securities of $466.1 million. We have also received $48.9 million of gross proceeds, before deducting commissions of $0.5 million, from sales made under the Stifel ATM Facility subsequent to June 30, 2026. We will need to raise additional capital in the future to fund our planned future operations. We expect that our existing cash, cash equivalents and marketable securities, including the net proceeds from sales of our common stock under the Stifel ATM Facility subsequent to June 30, 2026, will enable us to fund our operating expenses and capital expenditure requirements into early 2029. We have based this estimate on assumptions that may prove to be wrong and we could exhaust our capital resources sooner than we expect. 20 We expect our expenses to increase substantially if, and as, we: • continue clinical development of our product candidate and any future product candidates, including in particular the expenses associated with our clinical trials; • incur third party manufacturing costs to support our clinical trials of our product candidate and any future product candidates and, if approved, their commercialization; • seek to identify and develop additional product candidates; • seek regulatory and marketing approvals for our product candidate and any future product candidates; • establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates; • adapt our regulatory compliance efforts to incorporate requirements to applicable marketed products; • acquire or in-license products, product candidates, or technologies; • maintain, expand, enforce, defend and protect our intellectual property; • hire additional clinical, quality control, manufacturing and other scientific personnel; • add operational, financial and management information systems and personnel; • expand our office facility or establish dedicated laboratory and manufacturing facilities; and • experience any delays or encounter any issues with any of the above. In addition, we expect to continue to incur additional costs associated with operating as a public company, including significant legal, audit, accounting, investor and public relations, regulatory, tax-related, director and officer insurance premiums, investor relations and other expenses. Developing pharmaceutical products, including conducting clinical trials, is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval for any product candidates or generate revenue from the sale of any product candidate for which we may obtain marketing approval. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for at least several years, if ever. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the public or private sale of our equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. To the extent that we raise additional capital through the sale of our equity or convertible debt securities, including through the use of the Stifel ATM Facility, the ownership interest of our shareholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to obtain additional funding, we could be forced to delay, reduce or eliminate some or all of our research and development programs, product portfolio expansion or any commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. If we raise funds through strategic collaborations or other similar arrangements with third parties, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or product candidates or may have to grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. Our ability to raise additional funds may be adversely impacted by worsening global economic conditions and disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from worsening geopolitical tensions and adverse macroeconomic conditions or otherwise. Because of the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of increased expenses, and there is no assurance that we will ever be profitable or generate positive cash flow from operating activities. We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements that have, or are reasonably likely to have, a material current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, cash requirements or capital resources. 21 Cash Flows The following table provides information regarding our cash flows for the periods presented (in thousands): Six Months Ended June 30, 2026 2025 Net cash used in operating activities $ (63,624 ) $ (66,250 ) Net cash (used in) provided by investing activities (299,771 ) 416 Net cash provided by financing activities 74,764 174,459 Net (decrease) increase in cash, cash equivalents and restricted cash equivalents $ (288,631 ) $ 108,625 Operating Activities Net cash used in operating activities was $63.6 million for the six months ended June 30, 2026, reflecting a net loss of $282.4 million, offset by changes in operating assets and liabilities of $6.5 million and non-cash charges of $225.3 million. The non-cash charges primarily consisted of the change in fair value of warrant liabilities of $207.7 million and $18.3 million of stock-based compensation expense. The change in operating assets and liabilities was primarily due to the increase of $6.1 million of prepaid expense and other current assets, primarily driven by the increase of prepayments made for our clinical programs and an increase in accrued interest on marketable securities. Net cash used in operating activities was $66.3 million for the six months ended June 30, 2025, reflecting a net loss of $1,606.2 million, offset by changes in operating assets and liabilities of $2.0 million and non-cash charges of $1,537.9 million. The non-cash charges primarily consisted of the change in fair value of warrant liabilities of $1,299.9 million and the acquisition of in-process research and development of $222.6 million. Investing Activities Net cash used in investing activities was $299.8 million for the six months ended June 30, 2026, which consisted of the purchases of $355.5 million of marketable securities and $0.2 million of equipment, partially offset by $55.9 million of proceeds from the maturities of marketable securities. Net cash provided by investing activities was $0.4 million for the six months ended June 30, 2025, which consisted of proceeds of $0.8 million from the sale of property and equipment, partially offset by purchases of $0.4 million of property and equipment. Financing Activities Net cash provided by financing activities was $74.8 million for the six months ended June 30, 2026, which primarily consisted of $75.0 million in gross proceeds from the issuance of common stock in the March 2026 private placement, partially offset by $0.2 million of payments made in the period for issuance costs relating to the December 2025 and March 2026 private placements. Net cash provided by financing activities was $174.5 million for the six months ended June 30, 2025, which consisted of $175.0 million in proceeds from the issuance of pre-funded warrants, offset by the payment of $0.6 million of issuance costs related to the December 2024 private placement. Contractual Obligations and Other Commitments Contractual obligations relate to future minimum lease payments for an existing non-cancellable lease relating to corporate office space, with a term expiring in August 2031. Other commitments include license and collaboration agreements we have entered into with certain parties including the Telitacicept License Agreement discussed in Note 10 to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. Such arrangements require ongoing payments, including payments upon the achievement of certain development, regulatory and commercial milestones, receipt of sublicense income, as well as royalties on commercial sales. Payments under these arrangements will generally be expensed as incurred. There were no significant changes in contractual obligations and other commitments from that described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Contractual Obligations and Other Commitments” in our 2025 Annual Report. We also have agreements with certain vendors for various services, including services related to clinical operations and support, which we are not contractually able to terminate for convenience and avoid any and all future obligations to the vendors. Under such agreements, we are contractually obligated to make certain payments to vendors to reimburse them for their unrecoverable outlays incurred prior to cancellation. The exact amounts of such obligations are dependent on the timing of termination and the exact terms of the relevant agreement and cannot be reasonably estimated. We do not include these payments in this summary as they are not fixed and estimable. 22 Recent Accounting Pronouncements There are no new significant recent accounting pronouncements which may materially impact our financial statements. Item 3. Quantitative and Qualitati ve Disclosures About Market Risk. We are a smaller reporting company as defined by Item 10 of Regulation S-K and are not required to provide the information otherwise required under this item. Item 4. Controls and Procedures. Evaluation of Disclosure Controls and Procedures Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated, as of the end of the period covered by this Quarterly Report on Form 10-Q, the effectiveness of our disclosure controls and procedures. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2026, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures as of such date were effective at the reasonable assurance level. Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended June 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 23 PART II—OTHER INFORMATION Item 1. Legal Proceedings. We are not currently a party to any material legal proceedings. From time to time, we may become involved in other litigation or legal proceedings relating to claims arising from the ordinary course of business. Item 1A. Ris k Factors. The following risk factors and other information included in this Quarterly Report on Form 10-Q (“Quarterly Report”), including our condensed consolidated financial statements and related notes thereto, as well as our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (“Annual Report”), including our financial statements and related notes thereto, should be carefully considered. The risks and uncertainties described below are not the only risks and uncertainties we face. Additional risks and uncertainties not presently known to us or that we presently deem less significant may also impair our business operations. Please see the discussion regarding some of the forward-looking statements that are qualified by these risk factors contained elsewhere in this Quarterly Report. If any of the following risks occur, our business, financial condition, results of operations and future growth prospects could be materially and adversely affected. Risks Related to Our Financial Position and Need for Additional Capital We have incurred significant net losses since inception. We expect to incur net losses for the foreseeable future and may never achieve or maintain profitability. Since inception, we have not generated any revenue and have incurred significant operating losses. For the three months ended June 30, 2026 and 2025, our net loss was $62.8 million and $1,573.7 million, respectively. For the six months ended June 30, 2026 and 2025, our net loss was $282.4 million and $1,606.2 million, respectively. As of June 30, 2026, we had an accumulated deficit of $1,435.4 million. We have financed our operations primarily through the sale of our capital stock, including the sale of warrants to purchase our common stock. We have devoted all of our efforts to organizing and staffing our company, business and scientific planning, raising capital, acquiring and developing technology, identifying potential product candidates, undertaking studies of potential product candidates and evaluating a clinical path for our pipeline programs. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net losses we incur may fluctuate significantly from quarter to quarter. We anticipate that our expenses will increase substantially if and as we: • advance and complete clinical trials of telitacicept in gMG and SjD; • initiate clinical development of telitacicept in additional indications; • initiate additional research programs and development of other potential product candidates; • initiate preclinical testing and clinical trials for any other product candidates we identify and develop; • maintain, expand, enforce, defend and protect our intellectual property portfolio and provide reimbursement of third-party expenses related to our patent portfolio; • seek marketing approvals for any product candidates that successfully complete clinical trials; • adapt our regulatory compliance efforts to incorporate requirements applicable to marketed products; • hire additional research and development and clinical personnel; • hire commercial personnel and advance market access and reimbursement strategies; • add operational, financial and management information systems and personnel, including personnel to support our product development; • acquire or in-license product candidates, intellectual property and technologies; • develop or in-license manufacturing and distribution technologies; • rely on collaborators or other third parties to manufacture current good manufacturing practices (“cGMP”) material for clinical trials or potential commercial sales; • establish a commercialization infrastructure and develop internal and external manufacturing and distribution capabilities to commercialize any product candidates for which we may obtain regulatory approval; • should we decide to do so and receive approval for any of our product candidates, build and maintain, or purchase and validate, commercial-scale manufacturing facilities designed to comply with cGMP requirements; and 24 • operate as a public company. We have not completed clinical development of any product candidate and expect that it will be years, if ever, before we have a product candidate ready for commercialization. To become and remain profitable, we must develop and, either directly or through collaborators, eventually commercialize a product or products with significant market potential. This will require us to be successful in a range of challenging activities, including identifying product candidates, completing preclinical testing and clinical trials of product candidates, obtaining marketing approval for these product candidates, manufacturing, marketing and selling those products for which we may obtain marketing approval and satisfying any post-marketing requirements. We may never succeed in these activities and, even if we do, may never generate revenues that are significant or large enough to achieve profitability. Our product candidate and research programs are currently in clinical development. Because of the numerous risks and uncertainties associated with developing product candidates, we are unable to predict the extent of any future losses or when we will become profitable, if at all. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations. A decline in the value of our company could also cause our stockholders to lose all or part of their investments in us. We will need substantial additional funding. If we are unable to raise capital when needed, we would be forced to delay, reduce or eliminate our research and product development programs or future commercialization efforts. We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the clinical development of telitacicept for the treatment of gMG and SjD and initiate clinical development of telitacicept in additional indications, and otherwise continue to advance our research programs in support of our pipeline. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution to the extent that such sales, marketing, manufacturing and distribution are not the responsibility of a collaborator. Further, we expect to continue to incur significant additional costs associated with operating as a public company this year and in future years. Accordingly, we will need to obtain substantial additional funding in order to maintain our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and product development programs or future commercialization efforts. As of June 30, 2026, our cash, cash equivalents and marketable securities were $466.1 million. We expect that our existing cash, cash equivalents and marketable securities as of June 30, 2026, in addition to the $48.4 million of net proceeds received from sales of our common stock under the Stifel ATM Facility in July 2026, will enable us to fund our operating expenses and capital expenditure requirements into early 2029. However, our operating plan may change as a result of factors currently unknown to us, and we may need to seek funding sooner than planned. Our future capital requirements will depend on many factors, including: • the progress, results and costs of clinical trials for telitacicept; • the costs of researching, developing, and initiating clinical trials of telitacicept in additional indications; • the scope, progress, results, costs of discovery, acquisition or in-licensing, preclinical development, formulation, development and clinical trials for other product candidates; • the costs of acquiring and expanding facilities to accommodate corporate, laboratory, and manufacturing needs; • the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights and defending intellectual property-related claims in the United States and internationally; • the costs, timing and outcome of regulatory review of any product candidates; • the costs of future activities, including product sales, medical affairs, marketing, manufacturing, distribution, coverage and reimbursement for any product candidates for which we receive regulatory approval; • our ability to establish and maintain collaborations on favorable terms, if at all; • the success of our collaborations, including ones we may establish, and of our license agreements; • the achievement of milestones or occurrence of other developments that trigger payments under any collaboration agreements we enter; • the extent to which we acquire or in-license product candidates, intellectual property and technologies; • the extent to which we develop or in-license manufacturing and distribution technologies; and • the costs of operating as a public company. 25 Conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, even if we successfully develop product candidates and those are approved, we may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for years, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize product candidates. We cannot be certain that additional funding will be available on acceptable terms, or at all. We have no committed source of additional capital and, if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of product candidates or other research and development initiatives. Our license agreements and any future collaboration agreements may also be terminated if we are unable to meet the payment or other obligations under the agreements. We could be required to seek collaborators for product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms our rights to product candidates in markets where we otherwise would seek to pursue development or commercialization ourselves. If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization of any product candidate, or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of operations. Any of the above events could significantly harm our business, prospects, financial condition and results of operations and cause the price of our common stock to decline. Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates. Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, government or private party grants, debt financings, collaborations, strategic alliances and licensing arrangements. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, including through the use of our at-the-market facility, our stockholders’ ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends and possibly other restrictions. For example, we have raised substantial amounts of capital through the issuance and sale of 11,500,000 shares of common stock in an underwritten public offering in November 2025, the issuance and sale of 13,876,032 shares of common stock in a private placement in December 2025, the issuance and sale of 5,338,078 shares of common stock in a private placement in March 2026, and sales made pursuant to our at-the-market facility. In addition, in December 2024, we issued and sold to certain institutional investors an aggregate of (i) 2,793,562 shares of common stock and (ii) warrants to purchase up to 3,491,953 shares of common stock (the “2024 Warrants”). In June 2025, we issued and sold to certain institutional investors warrants to purchase up to 34,999,999 shares of common stock (the “2025 PIPE Warrants”), and we also issued a warrant to purchase up to 16,000,000 shares of common stock (the “RemeGen Warrant”) as partial consideration for the Telitacicept License Agreement to a subsidiary of RemeGen. As of June 30, 2026, the 2024 Warrants and RemeGen Warrant remain outstanding and unexercised, and 19,522,260 of the 2025 PIPE Warrants remain outstanding and unexercised. In addition, as of June 30, 2026, we have outstanding options to purchase 7,545,245 shares of common stock, 604,285 performance stock units, and 373,811 restricted stock units, and we have 2,274,893 shares of common stock available for future issuance under our 2023 Inducement Plan, 517,674 shares of common stock available for future issuance under our Amended and Restated 2021 Equity Incentive Plan and 205,932 shares of common stock available for issuance under our Employee Stock Purchase Plan. Should all of these shares be issued, you would experience substantial dilution in ownership of our common stock. If we raise funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or we may have to grant licenses on terms that may not be favorable to us or commit to providing us with future payment streams. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Market volatility may further adversely impact our ability to access capital as and when needed. 26 We have a limited operating history, have not yet completed any clinical trials and have no history of commercializing products, which may make it difficult to evaluate the success of our business to date and to assess our future viability. We are a clinical-stage company with no products approved for marketing. We were founded in December 2015 and commenced operations in February 2016. Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, acquiring and developing our platform and technology, identifying product candidates and undertaking studies. Prior to our in-license of telitacicept from Remegen in June 2025, our efforts were focused on developing engineered hematopoietic stem cell transplants, chimeric antigen receptor-T cell therapies and antibody drug conjugates for the treatment of acute myeloid leukemia. We are currently developing telitacicept in global Phase 3 clinical trials for the treatment of gMG and SjD. The risk of failure for these activities is high. We have not yet demonstrated an ability to successfully complete any clinical trials, including large-scale, pivotal clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf or conduct sales and marketing activities necessary for successful commercialization. Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had a longer operating history. Our limited operating history may make it difficult to evaluate our technology and industry and predict our future performance. Our short history as an operating company makes any assessment of our future success or viability subject to significant uncertainty. We expect to encounter risks and difficulties frequently experienced by early stage companies in new and rapidly evolving fields. If we do not address these risks and difficulties successfully, our business could suffer. In addition, we may encounter other unforeseen expenses, difficulties, complications, delays and other known and unknown factors. We will need to transition from a company with a research focus to a company capable of supporting commercial activities. We may not be successful in such a transition. We have never generated revenue from product sales and may never become profitable. Our ability to generate revenue from product sales and achieve profitability depends on our ability, alone or with collaborators, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize, product candidates. We do not anticipate generating revenues from product sales for the next several years, if ever. Our ability to generate future revenue from product sales depends heavily on our, or our current or future collaborators’, ability to successfully: • advance and complete clinical trials of our product candidates, including telitacicept; • complete research and preclinical and clinical development of any other product candidates we may identify; • seek and obtain regulatory and marketing approvals for any product candidates for which we complete clinical trials; • launch and commercialize any product candidates for which we obtain regulatory and marketing approval by establishing a sales force, marketing and distribution infrastructure or, alternatively, collaborating with a commercialization partner; • qualify for coverage and adequate reimbursement by government and third-party payors for any product candidates for which we obtain regulatory and marketing approval; • establish and maintain supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and the market demand for any product candidates for which we obtain regulatory and marketing approval; • obtain market acceptance of product candidates as viable treatment options; • address competing technological and market developments; • implement internal systems and infrastructure, as needed; • negotiate favorable terms in any collaboration, licensing or other arrangements into which we may enter and perform our obligations in such arrangements; • maintain, protect, enforce, defend and expand our portfolio of intellectual property rights, including patents, trade secrets and know-how, in the United States and internationally; • avoid and defend against third-party interference, infringement and other intellectual property claims in the United States and internationally; and • attract, hire and retain qualified personnel. 27 Even if one or more of the product candidates we develop are approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. Our expenses could increase beyond expectations if we are required by the U.S. Food and Drug Administration (the “FDA”), the European Medicines Agency (the “EMA”) or other regulatory authorities to perform clinical and other studies in addition to those that we currently anticipate. Even if we are able to generate revenues from the sale of any approved product candidates, we may not become profitable and may need to obtain additional funding to continue operations. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations. A decline in the value of our company also could cause stockholders to lose all or part of their investment in us. Our ability to utilize our net operating loss carryforwards and certain other tax attributes to offset taxable income or taxes may be limited. As of December 31, 2025, we had gross federal net operating loss carryforwards of $411.7 million including $409.8 million that had an indefinite carryforward period and $1.9 million that were subject to expiration at various dates through 2037. Furthermore, we have state and local net operating loss carryforwards of $389.4 million which will expire at various dates through 2045. Portions of these net operating loss carryforwards could expire unused and be unavailable to offset future income tax liabilities. Under the legislation enacted in 2017, informally titled the Tax Cuts and Jobs Act (the “Tax Act”), as modified by the Coronavirus Aid, Relief, and Economic Security (the “CARES Act”) U.S. federal net operating losses incurred in taxable years beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility of such federal net operating losses in taxable years beginning after December 31, 2020, may be limited. It is uncertain how various states will respond to the Tax Act and the CARES Act. For state income tax purposes, there may be periods during which the use of net operating loss carryforwards is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Code”), and corresponding provisions of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in its equity ownership over a three-year period, the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change income or taxes may be limited. The completion of our initial public offering, together with private placements and other transactions that have occurred since our inception, may trigger such an ownership change pursuant to Section 382 of the Code. We have not yet completed a Section 382 analysis, and therefore, there can be no assurances that our net operating losses are not already limited. We may experience ownership changes as a result of subsequent shifts in our stock ownership, some of which may be outside of our control. If an ownership change occurs and our ability to use our net operating loss carryforwards is materially limited, it would harm our future operating results by effectively increasing our future tax obligations. There is a full valuation allowance for net deferred tax assets, including net operating loss carryforwards. Risks Related to Development, Manufacturing and Commercialization We are substantially dependent on the success of our lead product candidate, telitacicept. If we are unable to complete development of, obtain approval for and commercialize telitacicept in a timely manner, our business will be harmed. Our future success is dependent on our ability to timely advance and complete clinical trials, obtain marketing approval for and successfully commercialize our lead product candidate, telitacicept. We are investing significant efforts and financial resources in the research and development of telitacicept. Telitacicept is currently in global Phase 3 clinical trials for the treatment of gMG and SjD, and will require additional clinical development, evaluation of clinical and manufacturing activities, marketing approval from government regulators, substantial investment and significant marketing efforts before we can generate any revenues from product sales. We are not permitted to market or promote telitacicept or any other product candidate before we receive marketing approval from the FDA and comparable foreign regulatory authorities, and we may never receive such marketing approvals. The success of telitacicept will depend on several factors, including the following: • the approval or acceptance to initiate clinical trials by the applicable regulatory authorities in each country where we plan to conduct clinical trials; • the acceptance of individual investigational review boards (“IRBs”) and scientific review committees at each clinical trial site as to the adequacy of the preclinical data package to support clinical development of telitacicept and their overall general agreement with the use of telitacicept in the intended patient population in the intended manner; • the willingness of clinical investigators to place patients in clinical trials, and the willingness of patients to enroll in clinical trials; 28 • the successful and timely completion of the global Phase 3 clinical trials of telitacicept in gMG and SjD; • the initiation and successful patient enrollment and completion of additional clinical trials of telitacicept on a timely basis; • maintaining and establishing relationships with contract research organizations (“CROs”) and clinical sites for the clinical development of these programs both in the United States and internationally; • the frequency and severity of adverse events in the clinical trials; • the results of clinical trials conducted by third parties, including RemeGen, in autoimmune disorders if such trials result in changes to the standard of care for autoimmune disorders; • the efficacy, safety and tolerability profiles that are satisfactory to the FDA, the EMA or any comparable foreign regulatory authority for marketing approval; • the timely receipt of marketing approvals for our programs from applicable regulatory authorities; • the extent of any required post-marketing approval commitments to applicable regulatory authorities; • the maintenance of existing or the establishment of new supply arrangements with third-party suppliers and manufacturers for clinical development of our programs; • our ability to obtain and maintain arrangements with third-party manufacturers to produce finished products that are appropriate for commercial sale of our programs, if approved; • obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally; • the protection of our rights in our intellectual property portfolio; • the successful launch of commercial sales following any marketing approval; • a continued acceptable safety profile following any marketing approval; • commercial acceptance by patients, the medical community and third-party payors; • our ability to obtain coverage and adequate reimbursement from third-party payors for our products and patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement; and • our ability to compete with other treatments. We do not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights and the manufacturing, marketing, distribution and sales efforts of any future collaborator. If we are not successful with respect to one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize telitacicept, which would materially harm our business. If we do not receive marketing approval for telitacicept, we may not be able to continue our operations. We may derive results and data for telitacicept from clinical trials conducted by RemeGen; our access to the clinical results and data may be limited or delayed and there is no assurance that the clinical data from any such trials will be accepted or considered by the FDA, or other comparable regulatory authorities. RemeGen has received regulatory approval in China for telitacicept for the treatment of gMG, RA, SLE, IgA nephropathy, and SjD and has conducted and is conducting clinical trials of telitacicept in additional indications. While these trials may provide us with clinical data that can inform our future development strategy, we do not have control over the protocols, administration, or conduct of the trials or their compliance with regulatory requirements. There is also no assurance that the clinical data from any such clinical trials will be accepted or considered by the FDA or other comparable regulatory authorities. We have no control over the conduct and timing of, and communications with the National Medical Products Administration (“NMPA”) or other foreign regulatory agencies in Greater China with respect to, the trials that RemeGen is conducting for telitacicept. In addition, our access to the clinical results and data from these trials may be limited or delayed, which could adversely affect our development timelines and regulatory submissions. 29 Any data integrity issues or patient safety issues arising out of any of these trials would be beyond our control, yet could adversely affect our reputation and damage the clinical and commercial prospects for our product candidates. We are dependent on third parties accurately generating and reporting data related to our product candidates, and their conduct could adversely affect our business. We have and may in the future acquire or in-license our product candidates at various stages of development. For example, we in-licensed telitacicept from RemeGen. Our assumptions about the potential of telitacicept are partially based on data generated from preclinical studies and clinical trials conducted by RemeGen. We are dependent on RemeGen having conducted its research and development in accordance with the applicable protocols, informed consent, legal and regulatory requirements, and scientific standards, having accurately reported the results of all studies conducted, and having correctly collected the data from these studies. If these activities were not compliant, accurate or correct, the clinical development, regulatory approval or commercialization of telitacicept will be adversely affected. Additionally, in cases where third parties conduct clinical trials using our product candidates through partnership or licensing agreements, we face additional risks related to the conduct and outcome of those trials that are outside of our direct control. For example, issues such as poor data integrity, safety concerns, protocol violations, or failure to meet endpoints in these third-party trials could adversely impact the development timeline and regulatory approval process for those product candidates in other indications or territories, require additional studies, create negative market perception affecting future commercial potential, impact our ability to pursue strategic alternatives for such product candidates, or result in increased regulatory scrutiny across our programs. Our clinical trials may fail to demonstrate the safety and efficacy of our product candidates, or serious adverse or unacceptable side effects may be identified during the development of our product candidates, which could increase our costs or necessitate the abandonment or limitation of the development of our product candidates. If our product candidates are associated with side effects in clinical trials or have characteristics that are unexpected, our costs could increase or we may need to abandon their development or limit development to more narrow uses in which the side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. The FDA or an IRB may also require that we suspend, discontinue, or limit our clinical trials based on safety information. Such findings could further result in regulatory authorities failing to provide marketing authorization for our product candidates. Many product candidates that initially showed promise in early-stage testing have later been found to cause side effects that prevented further development of the product candidate. Before we can obtain marketing approvals for the commercial sale of our product candidates, we must demonstrate through lengthy, complex and expensive preclinical testing and clinical trials that our product candidates are both safe and effective for use in each target indication, and failures can occur at any stage of testing. Clinical trials often fail to demonstrate safety and efficacy of the product candidate studied for the target indication. Additionally, if we or others identify undesirable side effects caused by our product candidates, a number of potentially significant negative consequences could result, including: • we may need to abandon the development or limit the further development of our product candidates, including in various populations and for certain indications; • regulatory authorities may withdraw approval to market such product; • regulatory authorities may require additional warnings on the labels; • a medication guide outlining the risks of such side effects for distribution to patients may be required; • we could be sued and held liable for harm caused to patients; and • our reputation and physician or patient acceptance of our product candidates, if approved, may suffer. Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more subject data become available and are subject to audit and verification procedures that could result in material changes in the final data. From time to time, we may publicly disclose interim, topline or preliminary data from our clinical trials, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a full analysis of all data related to the particular trial. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. In addition, we may 30 report preliminary analyses of only certain endpoints rather than all endpoints. As a result, the interim, topline or preliminary results that we report may differ from future results of the same trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim, topline and preliminary data should be viewed with caution until the final data are available. We may also disclose interim data from our clinical trials. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as subject enrollment continues and more subject data become available. Adverse differences between interim, topline or preliminary data and final data could significantly harm our reputation and business prospects. Further, disclosure of interim, topline or preliminary data by us or by our competitors could result in volatility in the price of our common stock. Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the potential of the particular program, the likelihood of marketing approval or commercialization of the particular product candidate, any approved product, and our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is derived from information that is typically extensive, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular program, product candidate or our business. If the interim, topline or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to further develop, obtain marketing approval for and/or commercialize our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition. Success in preclinical studies or clinical trials may not be indicative of results in future clinical trials, particularly for clinical trials that involve only a small number of patients. Results from preclinical studies are not necessarily predictive of future clinical trial results, and interim results of a clinical trial are not necessarily indicative of final results. This risk is heightened when clinical trials involve only a small number of patients, which makes it difficult to predict whether early results from these trials will be indicative of the final results of the trials or be replicated in future trials. Further, success in preclinical studies and earlier stage clinical trials of telitacicept conducted by RemeGen, or the fact that telitacicept has received marketing approval in China in multiple indications, does not ensure that later clinical trials conducted by us will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of telitacicept for regulatory approval by the FDA or other comparable foreign regulatory authorities. For example, the results of RemeGen’s Phase 3 clinical trials of telitacicept in gMG and SjD may not be replicated in our ongoing global Phase 3 clinical trials of telitacicept in gMG and SjD due to a variety of factors, including differences in trial design, patient demographics and enrollment and placebo rates. Our product candidates may fail to show the desired safety and efficacy in clinical development despite positive results in preclinical studies or having successfully advanced through initial clinical trials. This failure to establish sufficient efficacy and safety could cause us to abandon clinical development of our product candidates. We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success. Because we have limited financial and managerial resources, we focus on product candidates and research programs that we identify for specific indications among many potential options. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future product candidates and research and development programs for specific indications may not yield any commercially viable products. For example, in 2025 we wound down our then-ongoing clinical and manufacturing operations and clinical trials and, after a strategic evaluation process, in June 2025 we entered into a license agreement with RemeGen related to telitacicept and focused our operations on the development of that clinical program. Further, if we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate. Any such event could have a material adverse effect on our business, financial condition, results of operations and prospects. 31 Even if a product candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success. The commercial success of our product candidates, if approved, will depend upon their degree of market acceptance by physicians, patients, third-party payors and others in the medical community. Even if any product candidate we develop receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, healthcare payors and others in the medical community. The degree of market acceptance of any product candidate we develop, if approved for commercial sale, will depend on a number of factors, including: • the efficacy and safety of such product candidate as demonstrated in clinical trials; • the efficacy and safety of other products that are used in combination or in sequence with our product; • the potential and perceived advantages of our product candidates compared to alternative treatments; • the limitation to our targeted patient population and limitations or warnings contained in approved labeling by the FDA or other regulatory authorities; • the ability to offer our products for sale at competitive prices; • convenience and ease of administration compared to alternative treatments; • the clinical indications for which the product candidate is approved by the FDA, the EMA or other regulatory authorities; • the willingness of the target patient population to try novel biologics and of physicians to prescribe these treatments; • product labeling or product insert requirements of the FDA, the EMA or other regulatory authorities, including any limitations or warnings contained in a product’s approved labeling; • relative convenience and ease of administration; • the timing of market introduction of competitive products; • publicity concerning our products or competing products and treatments; • the strength of marketing and distribution support; • availability of third-party coverage and sufficiency of reimbursement; and • the prevalence and severity of any side effects. Even if a product candidate is approved, such product may not achieve an adequate level of acceptance, we may not generate significant product revenues, and we may not become profitable. If, in the future, we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market our product candidates, we may not be successful in commercializing those product candidates if and when they are approved. We do not have a sales or marketing infrastructure and have limited experience in the sale, marketing or distribution of pharmaceutical products. To achieve commercial success for any approved product for which we retain sales and marketing responsibilities, we must either develop a sales and marketing organization or outsource these functions to third parties. In the future, we may choose to build a focused sales, marketing and commercial support infrastructure to sell, or participate in sales activities with our collaborators for, some of our product candidates if and when they are approved. There are risks involved with both establishing our own commercial capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force or reimbursement specialists is expensive and time consuming and could delay any product launch. If the commercial launch of a product candidate for which we recruit a sales force and establish marketing and other commercialization capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our commercialization personnel. Factors that may inhibit our efforts to commercialize our product candidates on our own include: • our inability to recruit and retain adequate numbers of effective sales, marketing, reimbursement, customer service, medical affairs and other support personnel; 32 • the inability of sales personnel to obtain access to physicians or educate adequate numbers of physicians on the benefits of prescribing any future products; • the inability of reimbursement professionals to negotiate arrangements for formulary access, reimbursement and other acceptance by payors; • restricted or closed distribution channels that make it difficult to distribute our product candidates to segments of the patient population; • the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and • unforeseen costs and expenses associated with creating an independent commercialization organization. If we enter into arrangements with third parties to perform sales, marketing, commercial support and distribution services, our product revenues or the profitability of these product revenues to us may be lower than if we were to market and sell products ourselves. In addition, we may not be successful in entering into arrangements with third parties to commercialize our product candidates or may be unable to do so on terms that are favorable to us. We may have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively. If we do not establish commercialization capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates. We face significant competition in an environment of rapid technological change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer or more advanced or effective than ours, which may harm our financial condition and our ability to successfully market or commercialize product candidates, if approved. The development and commercialization of new drug and biologic products is highly competitive. We will face competition with respect to our product candidates that we develop or commercialize in the future from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization. Competition in the autoimmune field is intense and involves multiple monoclonal antibodies (mAbs), other biologics and small molecules either already marketed or in development by many different companies including large pharmaceutical companies such as Alexion Pharmaceuticals, Inc. (Solaris and Ultomiris/Myasthenia Gravis), Amgen Inc. (“Amgen”) (Uplinza/Myasthenia Gravis), Argenx SE (VYVGART and VYVGART HYTRULO/Myasthenia Gravis), UCB S.A. (Rystiggo and Zilbrysq/Myasthenia Gravis), Johnson & Johnson (Imaavy/Myasthenia Gravis), GlaxoSmithKline plc (Benlysta/lupus), F. Hoffman-La Roche AG (Rituxan/often used off label). We face and expect to continue to face intense competition from other biopharmaceutical companies, who have launched or are developing products for the treatment of gMG and other autoimmune diseases. Competition for other indications is also fierce, with significant development in almost all of the indications we may develop for our product candidates. Novartis AG, CSL Behring, Grifols, S.A., Curavac, Inc., Takeda Pharmaceutical Company Limited, Immunovant, Inc., Cartesian Therapeutics, Inc., Amgen, Kyverna Therapeutics, Inc., Dianthus Therapeutics, Inc., Johnson & Johnson, Bristol-Myers Squibb Company, and Regeneron Pharmaceuticals Inc./Alnylam Pharmaceuticals, Inc., among others, are developing drugs that may have utility for the treatment of myasthenia gravis (MG) or Sjögren’s Disease (SjD). Any product candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future that are approved to treat the same diseases for which we may obtain approval for our product candidates. This may include other types of therapies, such as small molecule, CAR-T, antibody and/or protein therapies. Many of our current or potential competitors, either alone or with their collaboration partners, may have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize product candidates that are safer, more effective, have fewer or less severe side effects, are more convenient or are less 33 expensive than our product candidates or that would render our product candidates obsolete or non-competitive. Our competitors also may obtain FDA or other regulatory approval for their product candidates more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. Additionally, technologies developed by our competitors may render our product candidates uneconomical or obsolete, and we may not be successful in marketing any product candidates against competitors. In addition, as a result of the expiration or successful challenge of our patent rights, we could face more litigation with respect to the validity and/or scope of patents relating to our competitors’ products. The availability of our competitors’ products could limit the demand, and the price we are able to charge, for our product candidates, if approved. Negative developments in the field of protein-based therapies, including in particular fusion protein therapies or approved therapies or therapies in development for the treatment of B cell-mediated autoimmune diseases, could damage public perception of our product candidate and negatively affect our business. The commercial success of our product candidate will depend in part on public acceptance of the use of fusion protein therapies constructed by joining two or more domains encoded by different genes, as well as protein-based therapies more generally, i