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

An investment in shares of our Class A common stock involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this Annual Report on Form 10-K, including our financial statements and the related notes and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” before deciding whether to purchase, hold or sell shares of our Class A common stock. The occurrence of any of the risks described below could harm our business, financial condition, results of operations, growth prospects, and/or stock price or cause our actual results to differ materially from those contained in forward-looking statements we have made in this Annual Report on Form 10-K and those we may make from time to time. You should consider all of the risk factors described when evaluating our business.

We are a late clinical-stage biotechnology company and we have no products approved for commercial sale, have not generated any revenue from product sales and have incurred losses since inception. To date, we have devoted substantially all of our resources to our research and development efforts, pre-clinical studies and clinical trials, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital and providing general and administrative support for these operations. We have not yet demonstrated our ability to successfully 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 product commercialization. As a result, it may be more difficult to accurately predict our future success or viability than it couldwould be if we had a longer operating history.

In addition, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by late-stage biotechnology companies in rapidly evolving fields. We may face difficulty transitioning from a company with a researchclinical development focus to a company capable of successfully executing drug development activities and supporting commercial operations. If we do not adequately address these risks and difficulties or successfully make such a transition, our business, financial condition, results of operations and prospects will be significantly harmed.

Developing treatments for immunological and inflammatoryrare diseases, including conducting nonclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception, and we expect our expenses will increase in connection with our ongoing activities, particularly as we continue to conduct clinical trials of, and seek marketing approval for, our product candidates. We anticipate incurring significant costs associated with the development of our product candidates. Our expenses could increase beyond expectations if we are required by the FDA, or any comparable foreign regulatory authorityauthority, to perform clinical trials or nonclinical studies in addition to those that we currently anticipate. Other unanticipated costs may also arise. In addition, if we obtain marketing approval for atacicept,product MAU868, or VT-109,candidates, we expect to incur significant commercialization expenses related to drug sales, marketing, manufacturing and distribution. Because the design and outcome of our planned and anticipated clinical trials are highly uncertain, weWe cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of any product candidate we develop. We also will continue to incur costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in order to maintain our continuing operations.

As of December 31, 2024,2025, we had $640.9$714.6 million in cash, cash equivalents,equivalents and marketable securities. We expect that our existing cash, cash equivalents,equivalents and marketable securities will be sufficient to fund our planned operations and capital expenditure requirements for at leastbeyond the next 12 months from the date of this Annual Report on Form 10-K.Report. Our estimate is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned. Moreover, it is particularly difficult to estimate with certainty our future expenses given the dynamic nature of our business and the macroeconomic and geopolitical environment generally. We anticipate that our expenses will increase substantially if, and as, we:

initiate or continue nonclinical studies and clinical trials for atacicept, MAU868, VT-109, and any additionalour product candidates that we may pursue in the future;

attract, develop and retain additional clinical, scientific, quality control, commercial, and manufacturing management and administrative personnel; and add clinical, operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts.

Advancing the development of atacicept, MAU868, VT-109, and any futureour product candidates we may develop will require a significant amount of capital. Our working capital and available credit will not be sufficient to fund all of the activities that are necessary to complete the development of our product candidates through approval and commercial launch.

We have incurred net losses since inception,inception and wehave never generated revenue from product sales. We expect to continue to incur net losses forat theleast foreseeable future. In addition,until we mayhave beone unableor tomore continueapproved asproducts athat goingachieve concerncommercial over the long-term.success.

We have incurred net losses in each reporting period since the commencement of our operations and have not generated any revenue from product sales to date. We had net losses of $299.6 million, $152.1 million and $96.0 million for the fiscal years ended December 31, 20242025, 2024, and 2023, respectively. We had an accumulated deficit of $461.3$760.9 million as of December 31, 2024.2025. Our losses have resulted principally from expenses incurred in research and development and from managementgeneral and administrative costs and other expenses that we have incurred while building our business infrastructure. Our product candidates are in clinical and pre-clinical development. AsEven aif result,one or more product candidates is commercialized, we expect that it will be several years, if ever, before we have a commercialized product and generate revenue from product sales.sales will result in net income. Even if we succeed in receiving marketing approval for and commercializing our product candidates in one or more indications, we expect that we will continue to incur substantial research and development and other expenses as we continue the clinical development programs for our product candidates in other indications.

We expect to continue to incur increased expenses and operating losses for the foreseeable future as we continue our research and development efforts and seek to obtain regulatory approval for our product candidates. The net losses we incur may fluctuate significantly from quarter to quarter such that a period-to-period comparison of our results of operations may not be a goodan indication of our future performance. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had, and will continue to have, an adverse effect on our working capital. In any particular period, our operating results could be below the expectations of securities analysts or investors, which could cause our stock price to decline.

We have incurred losses and negative cash flows from operations. As a development stage company, we expect to incur significant and increasing losses at least until regulatory approval is granted for our product candidates. Regulatory approval is not guaranteed and may never be obtained. As a result, thesethere conditions raise substantial doubt about our ability to continue asis a goingpossibility concern overthat the long-term.company may never be profitable.

Our ability to generate revenue from product sales and achieve profitability depends on our ability, alone or with our collaboration partners, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize atacicept, MAU868, VT-109, and any futureour product candidates we may develop. We do not anticipate generating revenue from product sales in 2025.candidates. Our ability to generate revenue from product sales depends heavily on our and our current and potential future collaborators’ success in:

maintaining our rights under our existing license agreement with Ares, Novartisagreements and any similar agreements we may enter into in the future;

Even if atacicept, MAU868, VT-109, or any future product candidate that we may develop is approved for commercial sale, we anticipate incurring significant costs associated with commercializing anysuch approved product candidate. Our expenses could increase beyond expectations if we are required by the FDA or comparable foreign regulatory authorities to perform clinical trials or nonclinical studies in addition to those that we currently anticipate. Even if we are able to generate revenue from the sale of any approved products, we may not be able to reach or sustain profitabilityprofitability, and may need to obtain additional funding to continue operations.

In DecemberJune 2021,2025, the Companywe entered into a non-revolving loanLoan and securitySecurity agreementAgreement (the2025 Loan Agreement) with a loan syndicate involving Oxford Finance LLC, Oxford Finance Credit Fund II LP, Oxford Finance Credit Fund III LP, and Oxford Finance Credit Fund IV LP (collectively, Oxford) providing for borrowing capacity of up to $50.0$500.0 million. As of December 31, 2024,2025, the Company’sour outstanding debt balance under the 2025 Loan Agreement was $50.0$75.0 million. Our overall leverage and certain obligations and affirmative and negative covenants contained in the related documentation could adversely affect our financial health and business and future operations by limiting our ability to, among other things, satisfy our obligations under the 2025 Loan Agreement, refinance our debt on terms acceptable to us or at all, plan for and adjust to changing business, industry and market conditions, use our available cash flow to fund future acquisitions and make dividend payments, and obtain additional financing for working capital, to fund growth or for general corporate purposes, even when necessary to maintain adequate liquidity.

If we default under the 2025 Loan Agreement, Oxford may accelerate all of our repayment obligations and exercise all of their rights and remedies under the 2025 Loan Agreement and applicable law, potentially requiring us to renegotiate our agreement on terms less favorable to us. Further, if we are liquidated, the lenders’ right to repayment would be senior to the rights of the holders of our common stock to receive any proceeds from the liquidation. Oxford could declare a default upon the occurrence of customary events of default, including events that they interpret as a material adverse change as delineated in the 2025 Loan Agreement, payment defaults or breaches of certain affirmative or negative covenants, thereby requiring us to repay the loan immediately. Any declaration by the lender of an event of default could significantly harm our business and prospects and could cause the price of our common stock to decline. Additionally, if we raise any additional debt financing, the terms of such additional debt could further restrict our operating and financial flexibility.

We are substantially dependent on the success of our product candidates, atacicept and MAU868, which are currently in the clinical development stage, and VT-109, which is in the pre-clinical development stage.candidates. If we are unable to complete development of, obtain regulatory approval for and commercialize our product candidates in one or more indications and in a timely manner, our business, financial condition, results of operations and prospects will be significantly harmed.

Our future success is heavily dependent on our ability to timely complete clinical trials, obtain marketing approval for and successfully commercialize our product candidates. We expect that a substantial portion of our efforts and expenses over the next several years will continue to be devoted to the development of atacicept in our ongoingproduct clinical trials, as well as our efforts to evaluate MAU868 in kidney transplant recipients. We also expect to advance development of VT-109, with the potential to advance the molecule to clinical development upon further success.candidates.

We plan to invest significant efforts and financial resources in the research and development of our product candidates, which will require additional clinical development, evaluation of clinical, nonclinical and manufacturing activities, marketing approval from regulatory authorities, and significant marketing efforts before we can generate any revenues from product sales. We are not permitted to market or promote our product candidates before we receive marketing approval from the FDA and comparable foreign regulatory authorities, and we may never receive such marketing approvals. We cannot assure you that our planned clinical development programs for our product candidates will be completed in a timely manner, or at all, or that we will be able to obtain approval for atacicept,our MAU868,product or VT-109candidates from the FDA or comparable foreign regulatory authorities. If we are unable to complete development of, obtain regulatory approval for and commercialize our product candidates in one or more indications and in a timely manner, our business, financial condition, results of operations and prospects will be significantly harmed.

Clinical development is a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results. Failure can occur at any stage of clinical development. We have never submitted a BLA to the FDA or similar drug approval filings to comparable foreign authorities. If we are ultimately unable to obtain regulatory approval for our product candidates, we will be unable to generate product revenue and our business, financial condition, results of operations and prospects will be significantly harmed.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. The results of nonclinical studies and early clinical trials may not be predictive of the results of subsequent clinical trials. We have a limited operating history and to date have notlimited demonstratedexperience ourin ability to completeconducting large scale clinical trials.

Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through nonclinical studies and initial clinical trials. For example, atacicept has been the subject of clinical trials by prior sponsors, including a Phase 2 trial in SLE,systemic lupus erythematosus (SLE), that missed its primary endpoint in the overall study population. In the future, clinical trial failures may result from a multitude of factors including flaws in trial design, dose selection, placebo effect and patient enrollment criteria. A number of companies in the biotechnology industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. Based upon negative or inconclusive results, we or any potential future collaborator may decide, or regulators may require us,decide to conduct additional clinical trials or nonclinical studies. In addition, data obtained from trials and studies are susceptible to varying interpretations, and regulators may not interpret our data as favorably as we do, which may delay, limit or prevent regulatory approval. Any future delays or abandonment could harm our business, financial condition, results of operations and prospects. Even if our clinical trials are completed as planned, we cannot be certain that their results will support our proposed indications.

Our future clinical trials may not be successful. If any product candidate is found to be unsafe or lack efficacy, we will not be able to obtain regulatory approval for it and our business, financial condition, results of operations and prospects may be significantly harmed. In some instances, there can be significant variability in safety and/or efficacy results between different trials of the same product candidate due to numerous factors, including changes in trial protocols, differences in composition of the patient populations, adherence to the dosing regimen and other trial protocols and the dropout rate among clinical trial participants. Patients treated with our product candidates may also be undergoing surgical, radiation and chemotherapy treatments and may be using other approved products or investigational new drugs, which can cause side effects or adverse events that are unrelated to our product candidates. As a result, assessments of efficacy can vary widely for a particular patient, and from patient to patient and site to site within a clinical trial. This subjectivity can increase the uncertainty of, and adversely impact, our clinical trial outcomes. We do not know whether any clinical trials we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain marketing approval to market our product candidates.

In addition, we may rely in part on nonclinical, clinical and quality data generated by CROs and other third parties forin connection with our planned regulatory submissions. While we have or will have agreements governing these third parties’ services, we have limited influence over their actual performance. If these third parties do not make data available to us, or, if applicable, make regulatory submissions in a timely manner, our development programs may be significantly delayed, and we may need to conduct additional studies or collect additional data independently. In either case, our development costs would increase.

obtaining regulatory authorizations to commence a clinical trial or reaching a consensus with regulatory authorities on trial design;

changes to clinical trial protocolprotocols;

shutdowns, either temporarily or permanently, of any facility manufacturing our product candidates or any of their components, including by order from the FDA or comparable foreign regulatory authorities due to violations of current good manufacturing practice (cGMP), or similar foreign requirements, regulations or other applicable requirements;

Any delays in our clinical trials that occur as a result could shorten any period during which we may have the exclusive right to commercialize atacicept, MAU868, VT-109, or any otherour product candidates and our competitors may be able to bring products to market before we do, and the commercial viability of atacicept, MAU868, VT-109, or othersuch product candidates could be significantly reduced. Any of these occurrences may significantly harm our business, financial condition, results of operations and prospects.

Identifying and qualifying patients to participate in our clinical trials is critical to our success. We may encounter delays in enrolling, or be unable to enroll, a sufficient number of participants to complete any of our clinical trials, and even once enrolled we may be unable to retain a sufficient number of participants to complete any of our trials. In particular, as a result of the inherent difficulties in diagnosing IgAN, the availability of competitive products such as TARPEYO, FILSPARI and FABHALTA, and the significant competition for recruiting the limited number of patients who have the diseases for which our product candidates are being developed, there may be delays in enrolling the participants we need to complete clinical trials on a timely basis, or at all. Although we have engaged certain third-party investigators to assist with participant enrollment, there can be no assurance that we will be able to maintain our relationships with such third parties or that such third parties will be successful in helping us identify patients.

In addition, if any significant adverse events or other side effects are observed in any of our future clinical trials or other sponsor development programs of similar mechanism of action that may result in a drug class effect, it may make it more difficult for us to recruit patients to our clinical trials and participants may drop out of our trials, or we may be required to abandon the trials or our development efforts of one or more product candidates altogether. Our inability to enroll or retain a sufficient number of participants for our clinical trials would result in significant delays, which would increase our costs and have an adverse effect on our company.

We may develop atacicept, MAU868, VT-109, and potentially futureour product candidates,candidates in combination with other therapies, which exposes us to additional risks.

We may develop atacicept, MAU868, VT-109, and futureour product candidates in combination with one or more currently approved therapies. Even if atacicept, MAU868, VT-109, or anya product candidate we develop,develop were to receive marketing approval or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDA or similar regulatory authorities outside of the United States could revoke or modify approval of the therapy used in combination with our product candidate or that safety, efficacy, manufacturing or supply issues could arise with these existing therapies. This could result in our own products being removed from the market or being less successful commercially.

We may also evaluate atacicept, MAU868, VT-109, or any other futureour product candidates in combination with one or more other therapies that have not yet been approved for marketing by the FDA or similar regulatory authorities outside of the United States. We will not be able to market and sell atacicept, MAU868, VT-109, or anysuch product candidate we develop in combination with any such unapproved therapies that do not ultimately obtain marketing approval. If the FDA or similar regulatory authorities outside of the United States do not approve these other drugs or revoke their approval of, or if safety, efficacy, manufacturing, or supply issues arise with, the drugs we choose to evaluate in combination with atacicept, MAU868, VT-109, or any otherour product candidate we develop,candidates, we may be unable to obtain approval of or market atacicept, MAU868, VT-109 or any otherour product candidate we develop.candidates.

The incidence and prevalence for target patient populations of our product candidates in specific indications are based on estimates and third-party sources. If the market opportunities for atacicept, MAU868, VT-109, or any futureour product candidate we may develop,candidates, if and when approved, are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability might be materially and adversely affected.

ThePeriodically, we make estimates regarding the incidence and prevalence forof target patient populations offor particular diseases based on various third-party sources and internally generated analysis and use such estimates in making decisions regarding our drug development strategy, including acquiring or in-licensing product candidates inand specificdetermining indications are based on estimateswhich andto third-partyfocus sources.in nonclinical or clinical trials. These estimates may be inaccurate or based on imprecise data. For example, the total addressable market opportunity will depend on, among other things, acceptance of our drugs by the medical community and patient access, drug pricing and reimbursement. The number of patients in the addressable markets may turn out to be lower than expected, patients may not be otherwise amenable to treatment with our drugs, or new patients may become increasingly difficult to identify or gain access to. If the market opportunities for atacicept, MAU868, VT-109, or any futureour product candidate we may develop,candidates, if and when approved, are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve and sustain profitability might be materially and adversely affected.

The biotechnology industry is intensely competitive and subject to rapid and significant technological change. Our competitors include multinational pharmaceutical companies, specialized biotechnology companies and universities and other research institutions. The current standard-of-care for IgAN consists of treatment with off-label use of RAAS inhibitors, including ACE inhibitors and ARBs, to control blood pressure, or steroids with or without other immunosuppressive agents to non-specifically reduce inflammation. SGLT2 inhibitors, including AstraZeneca’s Farxiga, which is approved for chronic kidney disease, is becoming the standard-of-care in some geographies including the United States. Among emerging therapies, we consider our most direct competitors with respect to atacicept in IgAN to be approved products: the reformulated steroid from CalliditasAsahi TherapeuticsKasei AB,Corp., the anti-APRIL monoclonal antibody from Otsuka Pharmaceuticals, both the complement inhibitor and selective ETA receptor antagonist from Novartis, and the endothelin and angiotensin II receptor antagonist from Travere Therapeutics, Inc., and the complement inhibitor from NovartisInc.; programs in Phase 3 clinical development: Otsuka Pharmaceutical Co, Ltd., Novartis, Alnylam Pharmaceuticals Inc., Roche/IonisIonis, Vertex, AstraZeneca, Biogen, Takeda, and VertexNovartis; and the following companies with programs in Phase 2 of clinical development: AstraZeneca,Arrowhead BiogenPharmaceuticals, Inc.,NovelMed, and Eladon Pharmaceuticals and DiaMedica Therapeutics, Inc.Pharmaceuticals.

In the kidney transplant or HSCThematopoietic stem cell transplant setting, there are currently no anti-BK Virus (anti-BKV) therapies approved. The standard of care in both settings is to reduce immunosuppression as a first line, and potentially to offer intravenous immune globulin (IVIG) in kidney transplant recipients or antivirals with limited clinical evidence, including leflunomide and cidofovir, in either setting. There are few industry sponsored programs in development for these indications; forwe example,consider our most direct competitor to be Memo Therapeutics AG’s MTX-005,Anti-BKV, a neutralizing monoclonal antibody targetingin BKV is ina Phase 2/3 clinical trials.trial.

Many of our competitors have significantly greater financial, technical, human and other resources than we do and may be better equipped to develop, manufacture and market technologically superior products. In addition, many of these competitors have significantly greater experience than we have in undertaking nonclinical studies and human clinical trials of new pharmaceutical products and in obtaining regulatory approvals of human therapeutic products. Accordingly, our competitors may succeed in obtaining FDA or comparable approval for superior products. Many of our competitors have established and in-use distribution channels for the commercialization of their products, whereas we have no such proven channel or capabilities. In addition, many competitors have greater name recognition and more extensive collaborative relationships. 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.

Applications for atacicept, MAU868, VT-109, or any futureAny product candidate we may develop could fail to receive regulatory approval for many reasons, including the following:

the FDA or comparable foreign regulatory authorities may determine that our product candidatecandidates isare not safesafe, pure, and/or effective,potent (or effective), only moderately effectiveeffective, or have undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use;

the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval, potentially resulting in a restrictive label and limiting commercial use;

the data collected from clinical trials may not be sufficient to support the submission of a BLA,Biologics License Application (BLA), or other submission or to obtain regulatory approval in the United States or elsewhere;

the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

In addition, even if we obtain approval of our product candidates for a leadone indication, regulatory authorities may not approve themsuch product candidates for other indications, may impose significant limitations in the form of narrow indications, warnings, or a Risk Evaluation and Mitigation Strategy (REMS). Certain regulatory authorities may grant approval contingent on the performance of costly post-marketing clinical trials or may approve them with a label that does not include the labeling claims necessary or desirable for successful commercialization of our product candidates. In addition, if we are unable to obtain regulatory approval, or if regulatory approval results in a limited label, our business, financial condition, results of operation and prospects will be significantly harmed.

the timing of market introduction of the product candidate as well as competitive products, such as TARPEYO,TARPEYO®, FILSPARI®, FABHALTA®, VANRAFIA®, and FABHALTAVOYXACT®;

the availability of atacicept,our MAU868,product or VT-109candidates for use as a combination therapy;

Our business entails a significant risk of product liability and ifproduct weliability are unable to obtain sufficient insurance coverage, such inabilityclaims could significantly harm our business, financial condition, results of operations and prospects.

Our business exposes us to significant product liability risks inherent in the development, testing, manufacturing and marketing of therapeutic treatments. Product liability claims could delay or prevent completion of our development programs. If we succeed in marketingobtaining products,regulatory approval of a product, such claims could result in an FDA or other regulatory authority investigation of the safety and effectiveness of our product, our manufacturing processes and facilities or our marketing programs. FDA or other regulatory authority investigations could potentially lead to a recall of our product or more serious enforcement action, limitations on the approved indications for which it may be used or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims may also result in decreased demand for our product, injury to our reputation, costs to defend the related litigation, a diversion of management’s time and our resources and substantial monetary awards to trial participants or patients. We currently have product liability insurance that we believe is appropriate for our stage of development and may need to obtain higher levels priorat toa marketingfuture any product candidate, if approved.date. Any insurance we have or may obtain may not provide sufficient coverage against potential liabilities. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, we may be unable to obtain sufficient insurance at a reasonable cost to protect us against lossesliabilities caused by product liability claimsclaims, thatwhich could significantly harm our business, financial condition, results of operations and prospects.

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our financial statements and the related notes included elsewhere in this Annual Report.Report on Form 10-K. For a discussion of our financial condition and results of operations for 2024 as compared to 2023, except as set forth below, please refer to Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2024, which discussion is incorporated by reference herein.

We have incurred significant operating losses since the commencement of our operations. Our net losses were $299.6 million, $152.1 millionmillion, and $96.0 million for the years ended December 31, 20242025, 2024, and 2023,2023 respectively, and we expect to incur significant and increasing losses for the foreseeable future as we continue to advance our product candidates toward commercialization. Our net losses may fluctuate significantly from period to period, depending on the timing of expenditures on our research and development activities. As of December 31, 2024,2025, we had an accumulated deficit of $461.3$760.9 million, compared to $309.1$461.3 million as of December 31, 2023.2024. Our primary use of cash is to fund operating expenses, which consist of research and development and general and administrative expenditures. Cash used to fund operating expenses depends on the timing of when we pay these expenses, as reflected in the changes in our working capital balances.

initiate or continue nonclinical studies and clinical trials for our product candidates; seek regulatory approvals for any product candidates that successfully complete clinical trials;

continue to establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates and related additional commercial manufacturing costs;

develop, maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secretssecrets, and know-how;

attract, hiredevelop and retain additional clinical, scientific, quality control, commercial, and manufacturing management and administrative personnel; and add clinical, operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts.

Research and development expenses increased by $47.9$89.1 million, or 61%,71%, to $215.3 million in the year ended December 31, 2025, from $126.2 million in the year ended December 31, 2024, from $78.2 million in the year ended December 31, 2023, primarily due to an increase of $15.7$23.4 million in contract drug manufacturing costs for commercialclinical and clinicalpotential usecommercial as we scaled up manufacturing activities for process performance qualification runs,use, an increase of $12.7$14.5 million in clinical trial expenses due to greater numbers of active sites and participantscompletion enrollingof enrollment in ORIGIN 3,3 and expenses incurred for the PIONEER, monthly dose range finding and ORIGIN EXTEND trials, an increase of $5.7$15.4 million in consulting and professional services, including a $3.2$9.4 million increase in medical affairs and commercial planning expenses as we prepare for potential regulatory approval and commercialization of atacicept, an increase of $12.4$33.0 million for employee compensation and related benefit expenses, including a $3.7$8.7 million increase in stock-based compensation expense, due to growth in research and development headcount, and an increase of $1.5$2.9 million in facilities and other, including a $0.9$1.9 million increase in primarily conference-related travel expenses to support R&Dresearch activities.and development activities, including travel associated with medical conferences.

We expect our research and development expenses to increase in future periods as we continue to initiate sites and enroll participants in ORIGIN 3, prepare applications forseek regulatory approval of atacicept in IgAN,IgAN initiatein the U.S. and other markets, conduct additional clinical trials of atacicept, including the ORIGIN EXTEND trial, initiated during 2024, and the PIONEER trial we plan to initiate in 2025, and if we expand development of atacicept in other indications or product configurations, or other product candidates.

General and administrative expenses increased by $17.2$59.2 million, or 72%,144%, to $100.2 million in the year ended December 31, 2025, from $41.0 million in the year ended December 31, 2024, from $23.8 million in the year ended December 31, 2023, primarily due to an increase of $7.5$30.3 million in payrollemployee compensation and related benefits expenses, including stock-based compensation, as a result of increased general and administrative employee headcount, an increase of $3.2$16.1 million in commercial and medical affairs expenses related to increased market research andresearch, market access activities,and health economics activities related to commercialization planning of atacicept, an increase of $2.0$3.3 million in outsidelegal, legalaccounting, and accounting expenses associated with increases in audit fees, outsourced accounting services, and general and patent-related legal expenses, and an increase of $1.9 million in consulting expensesexpenses, primarily related to increases inincluding non-employee director compensation.stock-based compensation, an increase of $2.5 million in software expenses, an increase of $1.8 million in corporate communications expenses, and an increase of $1.7 million in business travel expenses.

Other Income and Expenses,Income, Net

To date, we have funded our operations primarily through proceeds from the sale of shares of our common stock, redeemable convertible preferred stock, debt financing and convertible notes. From our inception through December 31, 2024,2025, we have raised aggregate net cash proceeds of approximately $1.0$1.3 billion from the issuance and sale of redeemable convertible preferred stock, convertible notes and common stock, and proceeds from our Loancurrent Agreementand withformer Oxfordloan Finance LLC (Oxford).agreements. Since the date of our incorporation, we have not generated any revenue from product sales and have incurred substantial operating losses and negative cash flows from operations.

In February 2024, we completed a follow-on public offering and issued 9,274,194 shares of common stock for net proceeds of approximately $269.6 million, after deducting underwriting fees and offering-related expenses. In October 2024, we completed a follow-on public offering and issued 7,142,858 shares of common stock, and in November 2024 we issued an additional 1,071,428 shares of common stock pursuant to the underwriters’ full exercise of the 30-day option to purchase additional shares. We received aggregate net proceeds of approximately $323.6 million, after deducting underwriting fees and offering-related expenses. In December 2025, we completed a follow-on public offering and issued 7,058,824 shares of common stock for net proceeds of approximately $281.3 million, after deducting underwriting fees and offering-related expenses.

We anticipate that we will continue to incur net losses for the foreseeable future as we continue research and development activities of atacicept,our MAU868,product and VT-109,candidates, hire additional staff, including clinical, commercial, operational, administrative and management personnel, and incur additional expenses associated with operating as a public company. We expect to incur significant expenses and operating losses for the foreseeable future as we advance our clinical development activities and our product candidate portfolio.portfolio and prepare for anticipated commercialization of atacicept. We expect that our research and development and general and administrative costs will increase substantially in connection with conducting additional clinical trials for our research programs and product candidates, contracting with third parties to support nonclinical studies and clinical trials, expanding our intellectual property portfolio, scaling up external commercial manufacturing capacity, building a sales, marketing and distribution infrastructure to commercialize any approved product candidates, and providing general and administrative support for our operations. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements, or other sources.

As of December 31, 2024,2025, we had cash, cash equivalents and marketable securities of $640.9$714.6 million, as compared to $160.7$640.9 million as of December 31, 2023.2024. We believe, based on our current operating plan, that our cash, cash equivalents and marketable securities as of December 31, 20242025 will be sufficient to fund our planned operations and capital expenditure requirements for at least the next 12 months from the date of this Annual Report.

Our primary uses of cash and operating expenses relate to contract drug manufacturing, clinical trial expenses, commercial launch planning, and paying employees and consultants to support our operations. Our research and development expenses in 20242025 were $126.2$215.3 million and we expect to increase our investment in research and development expenses in 2025.2026. Our general and administrative expenses were $41.0$100.2 million in 20242025 and we expect to increase our general and administrative expenses to support businessour growthanticipated commercial launch of atacicept in 2025.2026. On a long-term basis, we manage future cash requirements relative to our long-term business plans.

Operating costs also relate to our building leases for our office. Our operating lease obligations reflect those for our corporate headquarters office space in Brisbane, California, and our office and life science research space in South San Francisco, California, that is subleased to a third-party through September 2025, the remaining term of the lease.California. In August 2024, we entered into a non-cancellable operating lease for 40,232 square feet of office space in Brisbane, California, that has served as our corporate headquarters since November 2024. The term of this lease is 54 months.

2021 Loan and Security Agreement

On December 17, 2021, we entered into the 2021 Loan Agreement with Oxford, a Delaware limited liability company, as lender (Lender) and collateral agent.Agreement. The 2021 Loan Agreement providesprovided for a term loanloans (collectively, the Loan) in an aggregate maximum principal amount of $50.0 million, of which $5.0 million was funded on December 17, 2021, $20.0 million was funded on November 4, 2022, and the remaining $25.0 million was funded onin December 22, 2023. As of December 31, 2024, the Company’s outstanding borrowing under the Loan Agreement was $50.0 million.

In March 2023, we opted to extend the final maturity date of the Loan from December 2026,2026 to December 2027, based on positive Phase 2b clinical trial data of atacicept in IgAN, as provided in the 2021 Loan Agreement. We arewere required to make monthly interest-only payments for 60 months followed by full amortization through maturity.

Initially,The through December 30, 2021, the2025 Loan incurred interest at a per annum rate of 8.254%. Thereafter, the Loan bearsincurs interest at a floating per annum rate (based on the actual number of days elapsed divided by a year of 360 days) equal to the sum of (a) the greater of (i) 8.25%the 1-Month CME Term Secured Overnight Financing Rate (SOFR) and (ii) the3.75%, sum of (a) 1-Month CME Term SOFR as reported by CME Group Benchmark Administration Limited on the last business day of the month that immediately precedes the month in which the interest will accrue, andplus (b) 8.25%.4.95%.

We are permitted to prepay the 2025 Loan in full or in part at any time upon 10 business days’ written notice to the Lender,Oxford, subject to payment of the applicable Prepayment Fee (as defined below). Upon the earliest to occurearlier of the maturity date, acceleration of the 2025 Loan or prepayment of the 2025 Loan, we are required to make a final payment equal to 7.0%5.0% of the aggregate principal amount of the 2025 Loan (the Final Fee). Any prepayments of the Loan,2025 whether mandatory or voluntary,Loan must includebe anaccompanied amount equal to the sum ofby (a) the portion of the outstanding principal of the Loan being prepaid plus accrued and unpaid interest thereon through the prepayment date,thereon, (b) the Final Fee,Fee and (c) the Lender’s expenses and all other obligations that are due and payable to the Lender, and (d) a prepayment fee of (i) 3.0%2.0% of the portion of the 2025 Loan being prepaid if the repayment is on or before theJune first4, anniversary of the funding date of such term loan2027 or (ii) 2.0%1.0% of the portion of the 2025 Loan being prepaid if the repayment is after theJune first4, anniversary2027 ofthrough theJune funding4, date but on or before the second anniversary of the funding date of such term loan (the Prepayment Fee).2028. There is no Prepayment Fee for any prepayments occurring after theJune second4, anniversary of the funding date of such term loan.2028.

Our obligations under the 2025 Loan Agreement are secured by a security interest in substantially all of our assets, other than our intellectual property, which is subject to a negative pledge. The 2025 Loan Agreement doescontains not contain anytwo financial related covenants. IncludedAlso included in the 2025 Loan Agreement are customary representations and covenants that, subject to exceptions, restrict our ability to, among other things: declare dividends or redeem or repurchase equity interests; incur additional liens; make loans and investments; incur additional indebtedness; engage in mergers, acquisitionsacquisitions, and asset sales; transact with affiliates; undergo a change in control; add or change business locations; and engage in businesses that are not related to our existing business.

Critical Accounting Policies and Significant Judgments and Estimates

We estimate clinical trial expenses based on the services performed pursuant to contracts with clinical research organizations that conduct and manage clinical trials on our behalf. We also estimate manufacturing costs based on services performed pursuant to contracts with contract manufacturing organizations that develop and manufacture product on our behalf. In accruing service fees, we estimate the period over which services will be performed. These estimates are based on our communications with the third-party service providers and on information available at each balance sheet date. If the actual timing of the performance of services or the level of effort varies significantly from the estimate, we adjust the accrual accordingly to reflect the best information available at the time. When evaluating the adequacy of the accrued liabilities, we analyze progress of the studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Judgments and estimates are made in determining the prepaid and accrued balances at the end of the reporting period. Actual results may differ from our estimates. To date, there have been no material differences between our estimates of such expenses and the amounts actually incurred.

We have completed a limited number of clinical trials for our lead productproduct, candidate, atacicept,TRUTAKNA, and have noonly productsrecently approvedreceived accelerated approval for commercial sale,sale in the United States, which may make it difficult to evaluate our current business and predict our future success and viability.

We are a late clinical-stagecommercial-stage biotechnology company andand, until July 7, 2026, we havehad no products approved for commercial sale,sale. haveAt notthis generatedtime, anywe expect to record limited revenue from product sales during the third quarter of 2026 and have incurred losses since inception. To date, we have devoted substantially all of our resources to our research and development efforts, pre-clinical studies and clinical trials, preparing for commercialization, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital and providing general and administrative support for these operations. We have not yet demonstrated over an extended period of time our ability to successfully 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 product commercialization. As a result, it may be more difficult to accurately predict our future success or viability than it would be if we had a longer operating history.

In addition, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by biotechnology companies in rapidly evolving fields. We may face difficulty transitioning from a company with a clinical development focus to a company capable of supporting successful commercial operations. If we do not adequately address these risks and difficulties or successfully make such a transition, our business, financial condition, results of operations and prospects will be significantly harmed.

We will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs of our product candidates or future commercialization efforts.

Developing treatments for immunological and rare diseases, including conducting nonclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception, and we expect our expenses will increase in connection with our ongoing activities, particularly as we continue our commercialization efforts for our lead product and continue to conduct clinical trials of, and seek marketing approval for, our product candidates. We anticipate incurring significant commercialization expenses related to drug sales, marketing, manufacturing, and distribution costs associated with our commercialization efforts for our lead product. In addition, we expect to incur significant costs associated with the development of our product candidates. Our expenses could increase beyond expectations if we are required by the FDA, or any comparable foreign regulatory authority, to perform clinical trials or nonclinical studies in addition to those that we currently anticipate. Other unanticipated costs may also arise. In addition, if we obtain marketing approval for product candidates, we expect to incur significant commercialization expenses related to drug sales, marketing, manufacturing and distribution. We cannot reasonably estimate the actual amounts necessary to successfully commercialize our lead product or to complete the development and commercialization of anyour product candidate we develop.candidates. We also will continue to incur costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in order to maintain our continuing operations.

As of MarchJune 31,30, 2026, we had $596.8$499.2 million in cash, cash equivalents and marketable securities. We expect that our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operations and capital expenditure requirements beyond the next 12 months from the date of this Quarterly Report on Form 10-Q. Our estimate is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned. Moreover, it is particularly difficult to estimate with certainty our future expenses given the dynamic nature of our business and the macroeconomic and geopolitical environment generally. We anticipate that our expenses will increase substantially if, and as, we:

initiate or continue nonclinical studies and clinical trials for our lead product and product candidates;

establish and continue to build a sales, marketing and distribution infrastructure to commercialize any approved product candidatesproducts and related additional commercial manufacturing costs;

attract, develop and retain additional clinical, scientific, quality control, commercial, and manufacturing management and administrative personnel; and add clinical, operational, financial and management information systems and personnel, including personnel to support our product development and plannedongoing and future commercialization efforts.

AdvancingSuccessfully commercializing our lead product and advancing the development of our product candidates will require a significant amount of capital. Our working capital and available credit will not be sufficient to fund all of the activities that are necessary to successfully commercialize our lead product and complete the development of our product candidates through approval and commercial launch.

We will be required to obtain further funding through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources, which may dilute our stockholders or restrict our operating activities. Adequate additional financing may not be available to us on acceptable terms, or at all. Adverse geopolitical and macroeconomic developments, such as potential disruptions in access to bank deposits and lending commitments due to bank failures, ongoing military conflicts, related sanctions, actual and anticipated changes in interest rates, economic inflation and the responses by central banking authorities to control such inflation, could affect our ability to access capital as and when needed. Our failure to raise capital as and when needed, or on acceptable terms, would have a negative impact on our financial condition and our ability to pursue our business strategy, and we may have to delay, reduce the scope of, suspend or eliminate one or more of our research-stage programs, clinical trialstrials, or ongoing or future commercialization efforts.

We have incurred net losses since inception and haveexpect neverto generatedrecord limited revenue from product sales.sales during the third quarter of 2026. We expect to continue to incur net losses at least until we have one or more approved products that achieve commercial success.

We have incurred net losses in each reporting period since the commencement of our operations and haveexpect notto generatedrecord anylimited revenue from product sales toduring date.the third quarter of 2026. We had net losses of $121.0$109.5 million and $51.7$76.5 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. We had an accumulated deficit of $881.9$991.4 million as of MarchJune 31,30, 2026. Our losses have resulted principally from expenses incurred in research and development and from general and administrative costs and other expenses that we have incurred while building our business infrastructure. Our product candidates are in clinical and pre-clinical development. Even ifthough oneTRUTAKNA orreceived moreaccelerated productapproval candidatesby isthe commercialized,FDA for the treatment of IgAN in the U.S. in July 2026, we expect that it will be several years, if ever, before revenue from product sales will result in net income. EvenIn if we succeed in receiving marketing approval for and commercializing our product candidates in one or more indications,addition, we expect that we will continue to incur substantial research and development and other expenses as we continue the clinical development programs for our lead product and product candidates in other indications.

We expect to continue to incur increased expenses and operating losses for the foreseeable future as we continue to commercialize our lead product, continue our research and development efforts,efforts and seek to obtain regulatory approval for our product candidates, and progress our commercial planning activities.candidates. The net losses we incur may fluctuate significantly from quarter to quarter such that a period-to-period comparison of our results of operations may not be an indication of our future performance. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had, and will continue to have, an adverse effect on our working capital. In any particular period, our operating results could be below the expectations of securities analysts or investors, which could cause our stock price to decline.

We have incurred losses and negative cash flows from operations. As a developmentcompany stagewhich company,received its first FDA accelerated approval for a product in July 2026, we expect to continue to incur significant and increasing losses at least until regulatorywe approvalsuccessfully iscommercialize granteda forproduct. ourSuccessful commercialization of a product candidates. Regulatory approval is not guaranteed and may never be obtained.achieved. As a result, there is a possibility that the company may never be profitable.

Our ability to generate revenue from product sales and achieve profitability depends on our ability, alone or with our collaboration partners, to successfully commercialize our lead product and complete the development of, and obtain the regulatory approvals necessary to commercialize our product candidates. Our ability to generate revenue from product sales depends heavily on our and our potential future collaborators’ success in:

launching and commercializing productapproved candidates for which we obtain marketing approvalproducts by establishing a sales force, marketing, medical affairs and distribution infrastructure or, alternatively, collaborating with a commercialization partner;

achieving adequate access and reimbursement by government and third-party payors for our lead product and product candidates that we develop;

establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development of our product candidates and the market demand for our lead product and product candidates that we develop, if approved;

obtaining market acceptance of our lead product and any product candidates that we develop as viable treatment options;

Even if anya product candidate that we develop is approved for commercial sale, we anticipate incurring significant costs associated with commercializing such approved product candidate.candidate, including our lead product. Our expenses could increase beyond expectations if we are required by the FDA or comparable foreign regulatory authorities to perform clinical trials or nonclinical studies in addition to those that we currently anticipate. Even if we are able to generate revenue from the sale of any approved products, we may not be able to reach or sustain profitability, and may need to obtain additional funding to continue operations.

In June 2025, we entered into a Loan and Security Agreement (2025 Loan Agreement) with a loan syndicate involving Oxford Finance LLC, Oxford Finance Credit Fund II LP, Oxford Finance Credit Fund III LP, and Oxford Finance Credit Fund IV LP (collectively, Oxford) providing for borrowing capacity of up to $500.0 million. As of MarchJune 31,30, 2026, our outstanding debt balance under the 2025 Loan Agreement was $75.0 million. Our overall leverage and certain obligations and affirmative and negative covenants contained in the related documentation could adversely affect our financial health and business and future operations by limiting our ability to, among other things, satisfy our obligations under the 2025 Loan Agreement, refinance our debt on terms acceptable to us or at all, plan for and adjust to changing business, industry and market conditions, use our available cash flow to fund future acquisitions and make dividend payments, and obtain additional financing for working capital, to fund growth or for general corporate purposes, even when necessary to maintain adequate liquidity.

Risks related to the discovery,successful developmentcommercialization of our lead product and commercializationthe development of our product candidates

We aredepend, substantiallyin dependentpart, on the success of our product candidates. If we are unable to complete development of, obtain regulatory approval for and successfully commercialize our product candidates in one or more indications and in a timely manner, our business, financial condition, results of operations and prospects will be significantly harmed.

Our future success isdepends, heavilyin dependentpart, on our ability to timely complete clinical trials, obtain marketing approval for and successfully commercialize our product candidates. We expect that a substantial portion of our efforts and expenses over the next several years will continue to be devoted to the development of our product candidates.

We plan to invest significant efforts and financial resources in the research and development of our product candidates, which will require additional clinical development, evaluation of clinical, nonclinical and manufacturing activities, marketing approval from regulatory authorities, and significant marketing efforts before we can generate any revenues from product sales. We are not permitted to market or promote our product candidates before we receive marketing approval from the FDA and comparable foreign regulatory authorities, and we may never receive such marketing approvals. We cannot assure you that our planned clinical development programs for our product candidates will be completed in a timely manner, or at all, or that we will be able to obtain approval for our product candidates from the FDA or comparable foreign regulatory authorities. If we are unable to complete development of, obtain regulatory approval for and successfully commercialize our product candidates in one or more indications and in a timely manner, our business, financial condition, results of operations and prospects will be significantly harmed.

Clinical development is a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results. Failure can occur at any stage of clinical development. If we are ultimately unable to obtain regulatory approval for our product candidates, we will be unable to generate product revenue and our business, financial condition, results of operations and prospects will be significantly harmed.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. The results of nonclinical studies and early clinical trials may not be predictive of the results of subsequent clinical trials. We have a limited operating history and have limited experience in conducting large scale clinical trials.

Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through nonclinical studies and initial clinical trials. For example, atacicept has been the subject of clinical trials by prior sponsors, including a Phase 2 trial in systemic lupus erythematosus (SLE),erythematosus, that missed its primary endpoint in the overall study population. In the future, clinical trial failures may result from a multitude of factors including flaws in trial design, dose selection, placebo effect and patient enrollment criteria. A number of companies in the biotechnology industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. Based upon negative or inconclusive results, we or any potential future collaborator may decide to conduct additional clinical trials or nonclinical studies. Any future delays or abandonment could harm our business, financial condition, results of operations and prospects. Even if our clinical trials are completed as planned, we cannot be certain that their results will support our proposed indications.

In addition, we relyrely, in partpart, on nonclinical, clinical and quality data generated by CROs and other third parties in connection with our planned regulatory submissions. While we have or will have agreements governing these third parties’ services, we have limited influence over their actual performance. If these third parties do not make data available to us, or, if applicable, make regulatory submissions in a timely manner, our development programs may be significantly delayed, and we may need to conduct additional studies or collect additional data independently. In either case, our development costs would increase.

Moreover, nonclinical and clinical data are often susceptible to varying interpretations and analyses and many companies that believed their product candidates performed satisfactorily in nonclinical studies and clinical trials nonetheless failed to obtain FDA or comparable foreign regulatory authority approval. We cannot guarantee that the FDA or foreign regulatory authorities will interpret trial results as we do, and more trials could be required before we are able to submit an application seeking approval of our product candidates. To the extent that the results of the trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates. Even if regulatory approval is secured,secured for a product candidate, the terms of such approval may limit the scope and use, which may also limit commercial potential. Furthermore, the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval, which may lead to the FDA or comparable foreign regulatory authorities delaying, limiting or denying approval of a product candidate.

Further, conducting clinical trials in foreign countries, as we may do for our lead product and product candidates, presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled participants in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, as well as political and economic risks relevant to such foreign countries.

Enrollment and retention of participants in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control, including difficultiesdue in identifyingpart patients with IgAN,to the availability of competitive products,products and significant competition for recruiting participants in clinical trials.

The European Union (EU) regulates medical devices and medicinal products separately, through different legislative instruments, and the applicable requirements will vary depending on the type of drug-device combination product. For instance, drug-delivery products intended to administer a medicinal product where the medicinal product and the device form a single integral product are regulated as medicinal products in the EU. In such a case, the marketing authorization application must include – where available – the results of the assessment of the conformity of the device part with the EU Medical Devices Regulation contained in the manufacturer’s EU declaration of conformity of the device or the relevant certificate issued by a notified body. If the marketing authorization application does not include the results of the conformity assessment and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required, the European Medicine Agency or the EU member state competent authority must require the applicant to provide a notified body opinion on the conformity of the device. By contrast, in case of drug-delivery products intended to administer a medicinal product where the device and the medicinal product do not form a single integral product (but are e.g. co-packaged), the medicinal product is regulated in accordance with the rules for medicinal products described above while the device part is regulated as a medical device and will have to comply with all the requirements set forth by the EU Medical Devices Regulation.

The biotechnology industry is intensely competitive and subject to rapid and significant technological change. Our competitors include multinational pharmaceutical companies, specialized biotechnology companies and universities and other research institutions. The current standard-of-care for IgAN consists of treatment with off-label use of renin-angiotensin-aldosterone system (RAAS) inhibitors, including ACE inhibitors and ARBs, to control blood pressure, or steroids with or without other immunosuppressive agents to non-specifically reduce inflammation. SGLT2 inhibitors, including AstraZeneca’s FARXIGA®, which is approved for chronic kidney disease, is becoming the standard-of-care in some geographies including the United States. Among emerging therapies, we consider our most direct competitors with respect to atacicept in IgANTRUTAKNA to be approved products: the reformulated steroid (TARPEYO®) from Asahi Kasei Corp., the anti-APRIL monoclonal antibody (VOYXACT®) from Otsuka Pharmaceuticals, both the complement inhibitor (FABHALTA®) and selective ETA receptor antagonist (VANRAFIA®) from Novartis, and the endothelin and angiotensin II receptor antagonist (FILSPARI®) from Travere Therapeutics, Inc.; and programs in Phase 3 clinical development: Roche/Ionis, Vertex, AstraZeneca, Biogen, Takeda, Novartis, and Novartis.Biohaven.

In the kidney transplant or hematopoietic stem cell transplant setting, there are currently no anti-BK Virus (anti-BKV) therapies approved. The standard of care in both settings is to reduce immunosuppression as a first line, and potentially to offer intravenous immune globulin (IVIG) in kidney transplant recipients or antivirals with limited clinical evidence, including leflunomide and cidofovir, in either setting. There are few industry sponsored programs in development for these indications; we consider our most direct competitor to be Memo Therapeutics AG’s Anti-BKV, a neutralizing monoclonal antibody in a Phase 2/3 clinical trial.

The current landscape of B cell modulators primarily includes monoclonal antibodies, or Fc-fusion proteins containing TACI or TACI variants, including atacicept.TRUTAKNA. VT-109 is a novel BAFF/APRIL dual-inhibitor B cell maturation antigen (BCMA) molecule which, if successfully developed, approved, and commercialized, may compete with the existing approaches to treat B cell mediated autoimmune diseases, many of which are described in the preceding paragraphs on IgAN. We consider the most advanced direct competitor to VT-109 to be the BCMA Fc-fusion protein from Aurinia Pharmaceuticals Inc., which is currently in Phase 1 clinical development.

Many of our competitors have significantly greater financial, technical, human and other resources than we do and may be better equipped to develop, manufacture and market technologically superior products. In addition, many of these competitors have significantly greater experience than we have in undertaking nonclinical studies and human clinical trials of new pharmaceutical products and in obtaining regulatory approvals of human therapeutic products. Accordingly, our competitors may succeed in obtaining FDA or comparable approval for superior products. Many of our competitors have established and in-use distribution channels for the commercialization of their products, whereas weour havechannels noand suchcapabilities provenare channelless or capabilities.established. In addition, many competitors have greater name recognition and more extensive collaborative relationships. 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.

We believe that atacicept has pipeline-in-a-molecule potential, with potential application in multiple diseases. Based on data fromIn the ORIGIN Phase 2b trial, the FDA granted Breakthrough Therapy Designation to atacicept for the treatment of IgAN. We have also committed to providing long-term access to atacicept for ORIGIN participants through ORIGIN EXTEND, a long-term Phase 2 extensionPIONEER studyclinical thattrial, offersfor ataciceptwhich we expect to participantsreport whoadditional completed ORIGIN Phase 2b or 3 until, if approved, commercial availabilityresults in theirthe countryfourth orquarter region.of We2026, we are evaluating atacicept in a broader population of IgAN patients as well as other autoimmune kidney diseases, including primary membranous nephropathy (pMN), focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD), in patients with anti-phospholipase A2 receptor (PLA2R) or anti-nephrin autoantibodies in the Phase 2 PIONEER clinical trial. Initial results from the Phase 2 PIONEER trial are expected in the second quarter of 2026.autoantibodies. Potential future indications include anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV),vasculitis, lupus nephritis (LN),nephritis, Sjogren’s disease, systemic lupus erythematosus (SLE),erythematosus, systemic sclerosis, generalized myasthenia gravis, and idiopathic thrombocytopenic purpura.

We also hold worldwide, exclusive development and commercial rights to MAU868, a potentially first-in-class monoclonal antibody to treat reactivated BK virus (BKV) infections, for which we completed a Phase 2 clinical trial in 2022. In January 2025, we acquired worldwide, exclusive development and commercial rights to VT-109, a novel, next-generation dualBAFF BAFF/and APRIL inhibitor that is in preclinical development. We believe that our current pipeline programs leverage the deep expertise of our team and have strong potential commercial synergies.

We do notcurrently have anyonly one product candidates approved for commercial sale,sale and weexpect haveto notrecord generated anylimited revenue from product sales.sales during the third quarter of 2026. Our ability to generate revenue sufficient to achieve profitability, if ever, will depend on the successful development and eventual commercialization of oneour orlead moreproduct and development of our product candidates, which we expect will take a number of years. We also do not own or operate, and currently have no plans to establish, any manufacturing facilities. We rely, and expect to continue to rely, on third parties for the manufacture of our lead product candidates for nonclinical and clinical testing, as well as for commercial manufacturing if any of our product candidates obtain marketing approval.candidates. We believe that this strategy allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment, and personnel while also enabling us to focus our expertise and resources on the successful commercialization of our lead product and development of our product candidates.

To date, we have funded our operations primarily through proceeds from the sale of shares of our common stock, redeemable convertible preferred stock, debt financing and convertible promissory notes. As of MarchJune 31,30, 2026, we had $596.8$499.2 million in cash, cash equivalents and marketable securities, compared to $714.6 million as of December 31, 2025.

We have incurred significant operating losses since the commencement of our operations. Our net losses were $121.0$109.5 million and $51.7$76.5 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively, and we expect to incur significant and increasing losses for the foreseeable future as we commercialize our lead product and continue to advance our product candidates toward commercialization. Our net losses may fluctuate significantly from period to period, depending on the timing of expenditures on our research and development activities. As of MarchJune 31,30, 2026, we had an accumulated deficit of $881.9$991.4 million, compared to $760.9 million as of December 31, 2025. Our primary use of cash is to fund operating expenses, which consist of research and development and general and administrative expenditures. Cash used to fund operating expenses depends on the timing of when we pay these expenses, as reflected in the changes in our working capital balances.

We expect to continue to incur net operating losses for at leastin the nextnear several years,term, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase. We expect our expenses and capital requirements will increase significantly in connection with our ongoing activities as we:

initiate or continue nonclinical studies and clinical trials for our lead product and product candidates; seek regulatory approvals for any product candidates that successfully complete clinical trials;

establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates and related additional commercial manufacturing costs;

attract, develop and retain additional clinical, scientific, quality control, commercial, and manufacturing management and administrative personnel; and add clinical, operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts.

We will require substantial additional funding to successfully commercialize our lead product, develop our product candidates and support our continuing operations. Until such time that we can generate significant revenue from product sales or other sources, if ever, we expect to finance our operations through the sale of equity, debt financings, or other capital sources, which could include income from collaborations, strategic partnerships, or marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. We may be unable to raise additional funds or to enter into such agreements or arrangements on favorable terms, or at all. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the disruptions to, and volatility in, the credit and financial markets in the United States and worldwide. Our failure to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on our business, results of operations or financial condition, including requiring us to have to delay, reduce or eliminate our product development or future commercialization efforts. Insufficient liquidity may also require us to relinquish rights to our lead product or product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our development efforts. We cannot provide assurance that we will ever be profitable or generate positive cash flow from operating activities.

Although we did not see a significant financial impact to our business operations as a result of recent geopolitical and macroeconomic developments during the three months ended MarchJune 31,30, 2026, there may be potential impacts to our business in the future that are highly uncertain and difficult to predict such as disruptions or restrictions in our supply chain, disruption or restrictions on our employees’ ability to travel, disruptions to or delays in ongoing non-clinical trials, clinical trials, third-party manufacturing supply and other operations, interruptions or delays in the operations of the FDA or other regulatory authorities, and continued elevated inflation and interest rates which may increase the cost of conducting business activities or cause changes in availability and cost of credit and impact our ability to raise capital and conduct business development activities. The ultimate impact of these geopolitical and macroeconomic developments, as well as any lasting effects on our business, is highly uncertain and subject to continued change, and we recognize that macroeconomic and geopolitical factors may continue to present unique challenges for us.

We believe that our existing cash, cash equivalents and marketable securities held as of MarchJune 31,30, 2026, will be sufficient to fund our planned operations and capital expenditure requirements for at least the next 12 months from the date of this Quarterly Report on Form 10-Q. However, should adverse geopolitical or macroeconomic events, such as those discussed above, any recession or depression associated with those events or other events described herein, continue for a prolonged period, our results of operations, financial condition, liquidity and cash flows could be materially impacted as a result of a lower likelihood of effectively and efficiently developing and successfully commercializing our lead product and effectively developing our product candidates.

Comparison of the Three and Six Months Ended MarchJune 31,30, 2026 and 2025

Research and development expenses represent a substantial portion of our operating expenses. Our research and development expenses consist primarily of direct and indirect expenses incurred in connection with the research and development of our lead product and product candidates. Direct expenses include costs incurred under agreements with third parties, including contract research organizations, contract drug manufacturing organizations and consultants directly related to our research and development of our lead product and product candidates, and license and milestone fees incurred as a result of our contractual obligations for our development candidates. Unless and untilUntil we receive marketing approval for oura product candidate, all drug manufacturing costs are expensed as research and development. Indirect expenses include employee compensation and other personnel-related expenses, including stock-based compensation, facilities and depreciation related to buildings and equipment used by research and development personnel and activities and other expenses.

Research and development expenses increased by $44.7$1.9 million, or 108%,3%, to $86.0$60.1 million in the three months ended MarchJune 31,30, 2026, from $41.3$58.2 million in the three months ended MarchJune 31,30, 2025, due to an increase of $20.9$7.2 million in contract drug manufacturing costs for clinicalemployee compensation and potentialrelated commercialbenefit use,expenses, including a $2.7 million increase in stock-based compensation expense, as a result of growth in research and development employee headcount, an increase of $14.4 million in license and milestone expense related to current period recognition of a $15.0 million milestone payment due upon filing of the BLA, an increase of $2.4$3.0 million in clinical trial expenses mainly due to increased expenses for the PIONEER and ORIGIN EXTEND trials, an increase of $8.6 million for employee compensation and related benefit expenses, including a $3.0 million increase in stock-based compensation expense, due to growth in research and development headcount, and an increase of $0.4$0.5 million in facilities and other, including a $0.2$0.3 million increase in travel expenses supporting research and development activities, due mostly to travel associated with medical conferences,partially offset by a decrease of $1.8$7.8 million in contract drug manufacturing costs for clinical and potential commercial use and a decrease of $1.0 million in consulting and professional services, primarily related to advisory board and expert forum activities that incurred in 2025.

We expect our research and development expenses to increase in future periods as we seek full regulatory approval of atacicept in IgAN in the U.S. and regulatory approval in other non-U.S. markets, conduct additional clinical trials of atacicept, and if we expand development of atacicept in other indications or product configurations, or advance other product candidates.

General and administrative expenses increased by $23.2$30.5 million, or 146%,139%, to $39.1$52.4 million in the three months ended MarchJune 31,30, 2026, from $15.9$21.9 million in the three months ended MarchJune 31,30, 2025, primarily due to an increase of $12.7$16.2 million in employee compensation and related benefits expenses, including stock-based compensation, as a result of increased general and administrative employee headcount including sales personnel, an increase of $7.3$11.5 million in commercial planning and medical affairs expenses related to marketing, market research, market access, medical information, and health economics activities in preparation for the potentialanticipated commercializationcommercial launch of atacicept,TRUTAKNA, an increase of $0.9$0.7 million in software expenses toprimarily supportsupporting scalinganticipated commercial operations, and an increase of $0.4 million in legal, accounting, and audit expenses, offset by a decrease of $0.3 million in consulting expenses, including non-employee director stock-based compensation.expenses. The $2.2$1.9 million increase in other general and administrative expenses was primarily driven by an increaseincreases of $0.8$1.2 million in corporate communications expenses and $0.9 million in business travel expenses, partially offset by decreases of $0.3 million in recruiting and placement expenses,expenses anand increase of $0.7$0.2 million in business travel expenses,rent and an increase of $0.7 million in corporate communicationsfacilities expenses.

Other income, net, decreased by $1.4$0.6 million, or 25%,16%, to $4.1$3.0 million for the three months ended MarchJune 31,30, 2026, from $5.5$3.6 million in the three months ended MarchJune 31,30, 2025, primarily due to a decrease of $0.5$1.0 million in interest income resulting from a decrease in thelower average balancebalances of marketable securities held during the three months ended MarchJune 31,30, 2026, as compared to the three months ended MarchJune 31,30, 2025, and a decrease in sublease income of $0.5 million due to the expiration of a sublease to a third-party in September 2025, andpartially $0.4offset by a decrease of $0.5 million in amortization of deferred debt issuance costs for unfunded loan commitments relating to the refinancing of the Oxford credit facility in June 2025.

To date, we have funded our operations primarily through proceeds from the sale of shares of our common stock, redeemable convertible preferred stock, debt financing and convertible notes. From our inception through MarchJune 31,30, 2026, we have raised aggregate net cash proceeds of approximately $1.3 billion from the issuance and sale of redeemable convertible preferred stock, convertible notes and common stock, and proceeds from our Loan Agreements with Oxford. Since the date of our incorporation, we have not generated any revenue from product sales and have incurred substantial operating losses and negative cash flows from operations.

In August 2025, we entered into a Sales Agreement (the Sales Agreement) with TD Securities (USA) LLC (TD Cowen). Under the Sales Agreement, we may offer and sell, from time to time, through TD Cowen as our sales agent and/or principal, shares of our common stock, having an aggregate offering amount of up to $200 million (the Shares). We are not obligated to sell any sharesShares under thisthe agreement.Sales Agreement. We will pay TD Cowen a commission of up to 3.0% of the gross sales proceeds of any Shares sold through TD Cowen under the Sales Agreement. As of MarchJune 31,30, 2026, there have been no sales under the Sales Agreement.

We use our cash to fund operations, primarily to fund our research and development efforts, including clinical trials, establishingbuild a sales, marketing and maintainingdistribution infrastructure to support commercial activities, establish and maintain our intellectual property portfolio, hiringhire personnel, raisingraise capital, and providingprovide general and administrative support for these operations. Cash used to fund operating expenses is affected by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses and prepaid assets.

We anticipate that we will continue to incur net losses for the foreseeable future as we continue research and development activities offor our lead product and product candidates, hire additional staff, including clinical, commercial, operational, administrative and management personnel, and incur additional expenses associated with operating as a public company. We expect to incur significant expenses and operating losses for the foreseeable future as we continue to commercialize TRUTAKNA and advance our clinical development activities and our product candidate portfolio and prepare for anticipated commercialization of atacicept.portfolio. We expect that our research and development and selling, general and administrative costs will increase substantially in connection with conducting additional clinical trials for our research programsprograms, lead product, and product candidates, contracting with third parties to support nonclinical studies and clinical trials, expanding our intellectual property portfolio, scaling up external commercial manufacturing capacity, buildingcontinuing to build a sales, marketing and distribution infrastructure to successfully commercialize TRUTAKNA and any other approved product candidates, and providing general and administrative support for our operations. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements, or other sources.

As of MarchJune 31,30, 2026, we had cash, cash equivalents and marketable securities of $596.8$499.2 million, as compared to $714.6 million as of December 31, 2025. We believe, based on our current operating plan, that our cash, cash equivalents and marketable securities as of MarchJune 31,30, 2026 will be sufficient to fund our planned operations and capital expenditure requirements for at least the next 12 months from the date of this Quarterly Report on Form 10-Q.

In the threesix months ended MarchJune 31,30, 2026, we used $106.5$206.8 million of cash in operating activities, attributable to a net loss of $121.0$230.5 million and an increase in our net operating assets and liabilities of $13.7$20.2 million, partially offset by $15.0 million in license fees attributable to investing activities and adjustments for non-cash charges of $13.3$28.9 million. Non-cash charges primarily consisted of $13.2$29.1 million of stock-based compensation and $0.6$1.3 million net in accretion and amortization of loan exit fees and costs, partially offset by non-cash interest income of $0.8$1.9 million related to amortization of discount on purchases of marketable securities. The change in our net operating assets and liabilities was primarily due to a decrease of $8.0$7.3 million in accounts payable, an increase of $5.1$14.6 million in prepaid expense and other current assets, and a decrease of $0.4 million in accruedoperating and other currentlease liabilities, partially offset by an increase of $0.1$2.1 million in operatingaccrued leaseand other current liabilities.

In the threesix months ended MarchJune 31,30, 2025, we used $54.4$109.2 million of cash in operating activities, attributable to a net loss of $51.7$128.2 million, partially offset by adjustments for non-cash charges of $6.0$14.3 million, $0.8 million in license fees attributable to investing activities, and a decrease in our net operating assets and liabilities of $9.4$3.9 million. Non-cash charges primarily consisted of $7.7$17.2 million of stock-based compensation, non-cash interest income of $2.5$4.4 million related to amortization of discount on purchases of marketable securities, and a $0.5$0.9 million reduction in the carrying amount of operating lease right-of-use assets. The change in our net operating assets and liabilities was primarily due to aan decreaseincrease of $4.8$3.3 million in accrued and other current liabilities,liabilities and an increase of $1.6$5.5 million in accounts payable, partially offset by an increase of $5.9$4.2 million in prepaid expense and other current assets,assets and a decrease of $0.4$0.9 million in operating lease liabilities.

The increase in cash used in operating activities from the threesix months ended MarchJune 31,30, 2025 to the threesix months ended MarchJune 31,30, 2026 was primarily attributable to increased research and development and general and administrative expenses.

In the threesix months ended MarchJune 31,30, 2026, our investing activities used $137.8$104.9 million of cash, primarily resulting from $210.6$308.6 million used for purchases of marketable securities and $15.0 million paid in license fees, partially offset by $87.9$218.9 million provided by maturities of marketable securities.

In the threesix months ended MarchJune 31,30, 2025, our investing activities provided $15.3$43.9 million of cash, primarily resulting from $90.0 million for purchases of marketable securities, offset by $106.2$232.3 million provided by maturities of marketable securities, partially offset by $187.3 million used for purchases of marketable securities.

In the threesix months ended MarchJune 31,30, 2026, our financing activities provided $3.9$5.9 million of cash, resulting from proceeds from exercise of stock options and issuance of shares under our employee stock purchase plan.

In the threesix months ended MarchJune 31,30, 2025, our financing activities provided $1.5$21.8 million of cash, resulting from $23.3 million in net proceeds from borrowings from the initial funding under the 2025 Loan Agreement in June 2025, after repayment of borrowings under the 2021 Loan Agreement, $2.0 million in proceeds from exercise of stock options and issuance of shares under our employee stock purchase plan.plan, and $3.5 million in payment of deferred issuance costs related to unfunded loan commitments under the 2025 Loan Agreement.

During the threesix months ended MarchJune 31,30, 2026, there were no material changes to our contractual obligations and commitments from those described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Annual Report.

In June 2025, the Companywe refinanced itsour debt under the 2021 Loan Agreement by entering into a new non-revolving loan and security agreement, the proceeds of which were partially used to prepay the outstanding principal balance of the 2021 Loan Agreement in full. As a result, the Companywe no longer hashave any contractual obligations and commitments under the 2021 Loan Agreement.

We are permitted to prepay the 2025 Loan in full or in part at any time upon 10 business days’ written notice to Oxford, subject to payment of the applicable Prepayment Fee (as defined in (c) below). Upon the earliest to occur of the maturity date, acceleration of the 2025 Loan or prepayment of the 2025 Loan, we are required to make a final payment equal to 5.0% of the aggregate principal amount of the 2025 Loan (the Final Fee). Any prepayments of the 2025 Loan must be accompanied by (a) accrued and unpaid interest thereon, (b) the Final Fee and (c) prepayment fee of (i) 2.0% of the portion of the 2025 Loan being prepaid if the repayment is on or before June 4, 2027 or (ii) 1.0% of the portion of the 2025 Loan being prepaid if the repayment is after June 4, 2027 through June 4, 2028.2028 (the Prepayment Fee). There is no Prepayment Fee for any prepayments occurring after June 4, 2028.

Our obligations under the 2025 Loan Agreement are secured by a security interest in substantially all of our assets, other than our intellectual property, which is subject to a negative pledge. The 2025 Loan Agreement contains two financial related covenants. Also included in the 2025 Loan Agreement are customary representations and covenants that, subject to exceptions, restrict our ability to, among other things: declare dividends or redeem or repurchase equity interests; incur additional liens; make loans and investments; incur additional indebtedness; engage in mergers, acquisitions, and asset sales; transact with affiliates; undergo a change in control; add or change business locations; and engage in businesses that are not related to our existing business.

Our critical accounting policies are described in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Significant Judgments and Estimates” in the Annual Report and the notes to our unaudited condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. During the threesix months ended MarchJune 31,30, 2026, there were no material changes to our critical accounting policies and estimates from those discussed in the Annual Report.