VOR 10-K & 10-Q changes, risk factors and insider trading

Since inception, we have not generated any revenue and have incurred significant operating losses. For the yearsyear ended December 31, 20242025 and 2023,2024 our net loss was $116.9$696.0 million and $117.9$116.9 million, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $457.0$1,153.0 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, developing manufacturing capabilitiescandidates 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 ourtelitacicept productin candidates, including trem-celgMG and VCAR33 (previously called VCAR33ALLO)SjD;

initiate clinical development of othertelitacicept productin candidatesadditional indications;

continueinitiate our currentadditional research programs and development of other potential product candidates from our current research programs;

maintainrely andon expandcollaborators ouror ownother third parties to manufacture current Goodgood Manufacturingmanufacturing Practicespractices (“cGMP”) manufacturingmaterial facilityfor clinical trials or potential commercial sales;

We have not completed clinical development of any product candidate and expect that it will be several 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 candidatescandidate and research programs are currently only in the early stages ofclinical 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 expect our expenses to increase in connection with our ongoing activities, particularly as we continue the clinical development of trem-celtelitacicept infor AMLthe treatment of gMG and MDSSjD and our VCAR33 programs, initiate clinical development of trem-celtelitacicept in combinationadditional or in sequence with VCAR33 as a targeted therapeutic, which we refer to as the trem-cel+VCAR33 Treatment System,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 December 31, 2024,2025, our cash, cash equivalents and marketable securities were $91.9$455.2 million. We expect that our existing cash, cash equivalents and marketable securities as of December 31, 20242025, together with the expected proceeds from our 2026 Private Placement, will enable us to fund our operating expenses and capital expenditure requirements into theearly first quarter of 2026.2029. 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 our product candidatestelitacicept;

the scope, progress, results andresults, costs of discovery, acquisition or in-licensing, preclinical development, formulationformulation, development and clinical trials for other product candidates;

the costs of acquiring and expanding our facilities to accommodate corporate, laboratory, and manufacturing needs, including commercial manufacturingneeds;

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 several years, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives.

We are ana early-stageclinical-stage company.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. ForPrior example, VBP101,to our Phase 1/2a multicenter, open-label, first-in-human studyin-license of trem-celtelitacicept in patientsJune with2025, AML,our efforts were focused on developing engineered hematopoietic stem cell transplants, chimeric antigen receptor-T cell therapies and VBP301,antibody ourdrug conjugates for the treatment of acute myeloid leukemia. We are currently developing telitacicept in a global Phase 1/2,3 multicenter,clinical open-label,trials first-in-humanfor studythe treatment of VCAR33 in patients with relapsed or refractory AML, are each in the early stagesgMG and our other programs are still in the preclinical or research stage.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. For example, while we have demonstrated that our in-house cGMP clinical manufacturing facility at our Cambridge, MA headquarters can successfully manufacture clinical supply of VCAR33, we may fail to fully realize the cost-savings and efficiency gains that we expect, and we may be unsuccessful in making arrangements with third parties for commercial manufacturing. 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.

In addition, as a new business, 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.

advance and complete clinical trials of our product candidates, including trem-cel and VCAR33telitacicept;

negotiate favorable terms in any collaboration, licensing or other arrangements into which we may enter and performingperform our obligations in such arrangements;

Risks Related to Discovery, Development, Manufacturing and Commercialization eHSCs is an emerging technology containing risk and might never lead to commercially viable products.

We are substantially dependent on the success of our two most advancedlead product candidates,candidate, trem-cel and VCAR33.telitacicept. If we are unable to complete development of, obtain approval for and commercialize trem-cel or VCAR33telitacicept 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 candidatescandidate, trem-cel and VCAR33.telitacicept. We are investing significant efforts and financial resources in the research and development of thesetelitacicept. productTelitacicept candidates.is Wecurrently releasedin updatedglobal Phase 3 clinical datatrials fromfor VBP101,the our Phase 1/2a multicenter, open-label, first-in-human trialtreatment of trem-cel in combination with Mylotarg in patients with AML, most recently in December 2024 based on twenty-five patients,gMG and we are only in the early stages of advancing VCAR33 through clinical development. Trem-celSjD, and VCAR33 will each require additional clinical development, evaluation of clinical, preclinicalclinical 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 trem-cel, VCAR33telitacicept or any other product candidate,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 trem-cel and VCAR33telitacicept will depend on several factors, including the following:

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 trem-celtelitacicept and their overall general agreement with the use of trem-celtelitacicept in the intended patient population in the intended manner;

the willingness of clinical investigators to place patients in the clinical trials, and the willingness of patients to enroll in a clinical trial studying a first-in-human cell therapytrials;

the successful and timely completion of ourthe global Phase 1/2a3 clinical trialtrials of trem-cel,telitacicept thein developmentgMG ofand our VCAR33 programSjD;

the initiation and successful patient enrollment and completion of additional clinical trials of trem-cel and VCAR33telitacicept on a timely basis;

the results of clinical trials conducted by third partiesparties, including RemeGen, in hematopoieticautoimmune cell transplant (“HCT”)disorders if such trials result in changes to the standard of care for HCTautoimmune or otherwise cause us to change our clinical trial protocolsdisorders;

theour maintenanceability ofto existing,obtain orand the establishment of new, scaled productionmaintain arrangements with third-party manufacturers to obtain, or the ability of our in-house manufacturing facility to produce,produce finished products that are appropriate for commercial sale of our programs, if either is approved;

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 trem-cel and/or VCAR33,telitacicept, which would materially harm our business. If we do not receive marketing approvalsapproval for trem-cel and VCAR33telitacicept, we may not be able to continue our operations.

We have incurred significant operating losses since inception, including net losses of $116.9 million and $117.9$696.0 million for the yearsyear ended December 31, 20242025 and 2023,$116.9 respectively.million for the year ended December 31, 2024. As of December 31, 2024,2025, we had an accumulated deficit of $457.0$1,153.0 million.

As of December 31, 2024,2025, we had cash, cash equivalents and marketable securities of $91.9$455.2 million. WeBased on our current operating plan, we expect that our cash, cash equivalents and marketable securitiessecurities, attogether Decemberwith 31,the 2024expected proceeds from our 2026 Private Placement, will enable us to fund our operating expenses and capital expenditure requirements into theearly first quarter of 2026.2029.

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 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.

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, and internal manufacturing expenses.

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 more of our product candidates move into clinical development and later stages of clinical development.

the timing and progress of preclinical and clinical development activities;

the number and scope of preclinical and clinical programs we decide to pursue;

successful patient enrollment in, and the initiation of, clinical trials, as well as drop out or discontinuation rates or complications with donors;

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. General and administrative costs also consist of restructuring costs incurred under the Restructuring Plan, including severance payments, stock-based compensation modifications, and accelerated depreciation and amortization on long-lived assets and right-of-use assets.

We expect that our general and administrative expenses will increase as our business expands and we hire additional personnel to support our continued research and development activities, includingof 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 Securities and Exchange Commission (the “SEC”),SEC, Nasdaq listing standards and director and officer insurance premiums.

Other Income (Expense)

Other Income (Expense), net

Other income (expense), net decreased by $3.9$328.6 million for the year ended December 31, 2024,2025, compared to the year ended December 31, 2023.2024. The decrease inwas other income wasprimarily due to decreasesthe $334.4 million loss on the change in fair value of warrant liabilities, partially offset by a $1.6 million increase in interest receivedincome fromdue ourto an increase in cash, cash equivalents and marketable securities.securities and $4.1 million of income recognized from the sale of intellectual property in 2025.

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 debt financings and have received aggregate net proceeds from these transactions of approximately $517.1$1,019.1 million as of December 31, 2024.2025.

In order to fund our future operations, including our ongoing and planned clinical trials, on March 14, 2022, we filed a universal shelf registration statementstatement, 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 December 31, 2024,2025, $274.4$164.2 million remained available under the shelf registration statement, including $119.7$48.9 million reserved for at-the market offerings discussed below. This universal shelf registration statement expired on March 18, 2025. We intend to file a new universal shelf registration statement on March 20, 2025, to provide for aggregate offerings of up to $350.0 million of common stock, preferred stock, debt securities, warrants or any combination thereof, to replace the expired registration statement.

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 will pay Stifel a commission of up to 3.0% of the gross proceeds of any common stock sold through Stifel. We sold 249,0961,910,861 and 1,016,66212,454 shares of common stock under the Stifel ATM Facility during the years ended December 31, 20242025 and 2023,2024, respectively at a weighted average price per share of $1.64$37.06 and $4.75,$32.09, respectively, for aggregate net proceeds of $0.4$70.1 million and $4.7$0.3 million, respectively, after deducting commissions. As of December 31, 2024,2025, $119.7$48.9 million remained available to be sold under the Stifel ATM Facility.

2024 Private Placement

On December 26,27, 2024, we entered into a purchase agreement with certain institutional investors (collectively, the "Purchasers"), pursuant to which we issued and sold to the Purchasers in a private placement an aggregate of (i) 55,871,2602,793,562 shares of common stock and (ii) warrants to purchase up to 69,839,0753,491,953 shares of common stock at the closing of the private placement on December 30, 2024.2024 (the "December 2024 Private Placement"). Net proceeds from the private placement were $52.7 million, after deducting placement fees and issuance costs payable by us. If exercised for cash, the warrants would result in additional gross proceeds to us of up to approximately $58.5 million. Subject to certain limitations on exercise set forth in the warrants, the warrants are exercisable immediately and expire seven years from the date of issuance.

Since inception, we have not generated any revenue and have incurred significant operating losses. For the three months ended MarchJune 31,30, 2026 and 20252025, our net loss was $219.6$62.8 million and $32.5$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 MarchJune 31,30, 2026, we had an accumulated deficit of $1,372.6$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:

As of MarchJune 31,30, 2026, our cash, cash equivalents and marketable securities were $491.5$466.1 million. We expect that our existing cash, cash equivalents and marketable securities as of MarchJune 31,30, 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:

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 MarchJune 31,30, 2026, the 2024 Warrants and RemeGen Warrant remain outstanding and unexercised, and 19,792,71219,522,260 of the 2025 PIPE Warrants remain outstanding and unexercised. In addition, as of MarchJune 31,30, 2026, we have outstanding options to purchase 7,017,1227,545,245 shares of common stock, 604,285 performance stock units, and 346,325373,811 restricted stock units, and we have 2,455,5182,274,893 shares of common stock available for future issuance under our 2023 Inducement Plan, 1,497,093517,674 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.

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.

We may derive results and data for telitacicept from clinical trials conducted by RemeGen in China; 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, RARA, SLE, IgA nephropathy, and SLE,SjD and RemeGenhas conducted and is developing telitacicept inconducting clinical trials inof Chinatelitacicept 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. AnyIn addition, our access to the clinical results and data integrity issues or patient safety issues arising out of any offrom these trials wouldmay be beyondlimited ouror control,delayed, yetwhich could adversely affect our reputationdevelopment timelines and damageregulatory the clinical and commercial prospects for our product candidates.submissions.

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,Amgen Inc. (“Amgen”) (Uplinza/Myasthenia Gravis), Argenx SE (VYVGART and VYVGART HYTRULO/Myasthenia Gravis), UCB S.A. (RestageRystiggo 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 CoCompany Ltd,Limited, Immunovant, Inc., Cartesian Therapeutics, Inc., Amgen, Kyverna,Kyverna Dianthus,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).

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, including in particular approved therapies or therapies that are in development for the treatment of B cell-mediated autoimmune diseases. Telitacicept is a novel fusion protein in development for treating B cell mediatedcell-mediated autoimmune diseases that inhibits both BLyS (BAFF) and APRIL. Adverse events in post marketing use in any country in any approved indication or off label use, in clinical trials of our product candidate or in clinical trials of others developing similar product candidates, including RemeGen, and the resulting publicity, as well as any other negative developments that may occur in the future, including in connection with competitors’ therapies, could result in a decrease in demand for our product candidate. These events could also result in the suspension, discontinuation, or clinical hold of, or modifications to, our clinical trials. Our product candidate may not be accepted by the general public or the medical community and potential clinical trial subjects may be discouraged from enrolling in our clinical trials or early terminated from the clinical trials. As a result, we may not be able to continue, or may be delayed in conducting, our development programs.

There are a limited number of contract manufacturers who specialize in the manufacture of biologic products and those that do may still be developing appropriate processes, controls and facilities for large-scale production. While we believe that there will be sufficient sources of supply that can satisfy our clinical and commercial requirements, we cannot be certain that we will be able to identify and establish additional relationships with such sources, if necessary, in a timely manner or at all, and what the terms and costs of such new arrangements would be, or that such suppliers would be able to supply our potential commercial needs. Furthermore, in the event our primary manufacturer cannot meet our needs, any switch to an alternative manufacturer, if available, would result in a significant delay, would require FDA approval, and cause material additional costs.

Moreover, our trade secrets could otherwise become known or be independently discovered by our competitors or other third parties. Competitors and other third parties could attempt to replicate some or all of the competitive advantages we derive from our development efforts, willfully infringe our intellectual property rights, design around our protected technology or develop their own competitive technologies that fall outside of our intellectual property rights. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us. If our trade secrets are not adequately protected or sufficient to provide an advantage over our competitors, our competitive position could be adversely affected, as could our business. Additionally, if the steps taken to maintain our trade secrets are deemed inadequate, we may have insufficient recourse against third parties for misappropriating our trade secrets.

In addition, the U.S. government requires that any products embodying the subject invention or produced through the use of the subject invention be manufactured substantially in the United States. The manufacturing preference requirement can be waived if the owner of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible. This preference for U.S. manufacturers may limit our ability to contract with non-U.S. product manufacturers for products covered by such intellectual property. To the extent any of our current or future intellectual property is generated through the use of U.S. government funding, the provisions of the Bayh-Dole Act may similarly apply.

Our stock price is, and is likely to continue to be, volatile. For example, our stock traded within a range of a high price of $53.40 and a low price of $3.03 per share for the period of January 1, 2025 through MayAugust 7,6, 2026. As a result of volatility, our stockholders may not be able to sell their common stock at or above the prices at which they purchased their shares. Some of the factors that may cause the market price of our common stock to fluctuate include:

As a public company, and particularly after we are no longer an “emerging growth company,company” starting on January 1, 2027 as a result of becoming a large accelerated filer we will continue to incur significant legal, accounting and other expenses that we did not incur as a private company.expenses. The Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the Nasdaq Global Select Market and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. We expect that we will need to continue to hire additional accounting, finance and other personnel in connection with our efforts to comply with the requirements of being, a public company, and our management and other personnel will need to continue to devote a substantial amount of time towards maintaining compliance with these requirements. These requirements have increased and will continue to increase our legal and financial compliance costs and make some activities more time-consuming and costly. These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

Pursuant to SOX Section 404, we are required to furnish a report by our management on our internal control over financial reporting, but in fiscal year 2026, while we remain an emerging growth or a smaller reporting company with less than $100 million in annual revenue, we willhave not bebeen required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To maintain compliance with SOX Section 404 and achieve compliance within the prescribed period for the attestation report by our independent registered public accounting firm, we have and will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants, adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed timeframe or at all, that our internal control over financial reporting is effective as required by SOX Section 404. If we identify one or more material weaknesses, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

Unfavorable global economic conditions, new tariffstariffs, legislation or bank closures could adversely affect our business, financial condition or results of operations.

We could also be affected by new and increased tariffs or other legislation between the United States and other countries, including China. These additional tariffs and any retaliatory tariffs by other countries could substantially increase our costs associated with the manufacture and supply of our product candidates. The global trade environment is rapidly evolving, and the United States and other countries may impose additional new tariffs, the scope of which we are unable to predict but that may adversely impact our business. For example, on April 2, 2026, the U.S. presidential administration issued a proclamation entitled “Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients into the United States,” which would impose tariffs of up to 100% on certain covered imported patented pharmaceutical products and associated pharmaceutical ingredients, subject to exemptions and reduced-rate pathways. We currently contract with third parties outside the U.S. for the manufacture and supply of telitacicept, including suppliers in China. The scope, implementation and availability of exemptions or reduced-rate pathways under this proclamation remain uncertain, and telitacicept or any future product candidates may not qualify for such exemptions or pathways. If our activities or those of our third-party suppliers or service providers fall within the scope of any of these or other tariffs, our costs may increase significantly.

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”) and, rheumatoid arthritis (“RA”), and has two Biologics License Applications (“BLAs”) filed and pending in China for the treatment of 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, for the treatment of gMG.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.

We have incurred significant operating losses since inception, including net losses of $219.6$62.8 million and $32.5$1,573.7 million for the three months ended MarchJune 31,30, 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 MarchJune 31,30, 2026, we had an accumulated deficit of $1,372.6$1,435.4 million.

As of MarchJune 31,30, 2026, we had cash, cash equivalents and marketable securities of $491.5$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.

Comparison of Threethree Monthsmonths Endedended MarchJune 31,30, 2026 and 2025

General and administrative expenses were $17.6$21.9 million for the three months ended MarchJune 31,30, 2026, compared to $6.6$12.8 million for the three months ended MarchJune 31,30, 2025. The increase of $11.0$9.1 million was primarily due to a $7.4$7.3 million increase in stock-based compensation expense, a $1.4 million increase in personnel-related expenses, a $1.2$3.3 million increase in commercial-related expenses, and a $1.0$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 the new executivesmembers of our management team hired afterin the quartersecond endedand Marchthird 31,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 personnel-relatedcommercial-related expenses was due primarily to newan generalincrease administrativein employeescommercial hiredactivities duringas 2025,the includingCompany newprepares executives.for potential commercial launch as its clinical trials progress.

Other IncomeExpense, (Expense)Net

Other incomeexpense, (expense)net decreased by $185.2$1,284.4 million during the three months ended MarchJune 31,30, 2026, compared to the three months ended MarchJune 31,30, 2025. The decrease in other income (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.warrants, and a decrease in warrants outstanding compared to the prior year period.

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 MarchJune 31,30, 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 MarchJune 31,30, 2026, $164.2 million remainsremained available under this Shelf Registration Statement, including $48.9 million reserved for at-the-market offerings discussed below.

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 threesix months ended MarchJune 31,30, 2026. As of MarchJune 31,30, 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.

As of MarchJune 31,30, 2026, we had cash, cash equivalents and marketable securities of $491.5$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 securitiessecurities, 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.

Net cash used in operating activities was $38.2$63.6 million for the threesix months ended MarchJune 31,30, 2026, reflecting a net loss of $219.6$282.4 million, offset by changes in operating assets and liabilities of $15.5$6.5 million and non-cash charges of $196.9$225.3 million. The non-cash charges primarily consisted of the change in fair value of warrant liabilities of $188.4$207.7 million and $8.9$18.3 million of stock-based compensation expense. The change in operating assets and liabilities was primarily due to a decrease of $9.1 million of accounts payable and accrued expenses as much of the accrued expenses relating to the prior period were paid in the three months ended March 31, 2026. The change was also due to the increase of $6.4$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 $31.1$66.3 million for the threesix months ended MarchJune 31,30, 2025, reflecting a net loss of $32.5$1,606.2 millionmillion, andoffset netby cashchanges used of $2.6 million forin operating assets and liabilities,liabilities whichof were$2.0 partiallymillion offset byand non-cash charges of $4.1$1,537.9 million. The non-cash charges primarily consisted of stock-basedthe compensationchange expensein fair value of $1.9warrant million, non-cash lease expenseliabilities of $1.3$1,299.9 million and depreciationthe expenseacquisition of $0.8in-process research and development of $222.6 million.

Net cash used in investing activities was $263.2$299.8 million for the threesix months ended MarchJune 31,30, 2026, which consisted of the purchases of $276.5$355.5 million of marketable securities and $0.1$0.2 million of equipment, partially offset by $13.3$55.9 million of proceeds from the maturities of marketable securities. Net cash usedprovided inby investing activities was $0.2$0.4 million for the threesix months ended MarchJune 31,30, 2025, which primarily consisted of proceeds of $0.8 million from the sale of property and equipment, partially offset by purchases of $0.2$0.4 million of property and equipment.

Net cash provided by financing activities was $74.9$74.8 million for the threesix months ended MarchJune 31,30, 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 $0.1$0.2 million of payments made in the period for issuance costs relating to the December 2025 private placement. Net cash used in financing activities was $0.6 million for the three months endedand March 31, 2025, which primarily consisted of $0.6 million of payments for issuance costs relating to the December 20242026 private placement.placements.