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

We are a biopharmaceutical company with a limited operating history. We have historically incurred net losses. During the years ended December 31, 20242025 and 2023,2024, our net loss was $269.9$342.6 million and $237.7$269.9 million, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $995.9$1,338.5 million and cash, cash equivalents,equivalents and short-termmarketable investmentssecurities of $717.6$874.7 million.

We believeexpect that our current cash, cash equivalents and short-termmarketable investmentssecurities will be sufficient to fund our operations, including our clinical development plan described elsewhere in this Annual Report, and enable us to fund our operatingplanned expensesoperations andfor capitalat expenditureleast requirementstwelve intomonths from the second halfdate of 2027.issuance of the consolidated financial statements included in this Annual Report. We willmay need to raisesecure substantial additional capital to continue to fund our operations in the future. The amount and timing of our future funding requirements will depend on many factors, including the pace, results and costs of our clinical development effortsefforts, our ability to generate revenues from sales of veligrotug and elegrobart in the U.S., if approved, and macroeconomic conditions affecting our business and industry.

We have devoted substantially all of our financial resources to identify, acquire, and develop our product candidates, including conducting clinical trials and providing selling, general and administrative support for our operations. To date, we have financed our operations primarily through the sale of equity securities, convertible promissory notes andnotes, the Hercules Loan and Security Agreement, the Kissei Agreement, and the DRI Purchase and Sale Agreement. The amount of our future net losses will depend, in part, on the rate of our future expenditures and our ability to obtain funding through equity, debt financings or other non-dilutive sources of capital, or strategic collaborations. Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We expect our losses to increase as our product candidates continue advancing through clinical development and as new product candidates enter clinical trials and then advance through clinical development. It may be several years, if ever, before we complete pivotal clinical trials or have a product candidate approved for commercialization. We expect to invest significant funds into the research and development of our current product candidates to determine the potential to advance these product candidates to regulatory approval.

As of December 31, 2024,2025, we had $717.6$874.7 million of cash, cash equivalents,equivalents and short-termmarketable investments.securities. We believeexpect that our current cash, cash equivalents and short-termmarketable investmentssecurities will beenable sufficientus to fund our operations,planned includingoperations ourfor clinicalat developmentleast plantwelve describedmonths elsewherefrom the date of issuance of the consolidated financial statements included in this Annual Report, into the second half of 2027.Report. We willmay need to raisesecure additional capital to continue to fund our operations and service our obligations in the future. If we are unable to raisesecure additional capital when needed, we will not be able to continue as a going concern.

Developing our product candidates requires a substantial amount of capital. We expect our research and developmentoperating expenses to increase in connection with our ongoing activities, particularly as we advance our product candidates through clinical trialstrials, and pre-commercialpre-commercial, and commercial activities. We willmay need to raisesecure additional capital to fund our operations and such funding may not be available to us on acceptable terms, or at all.

We do not currently have any products approved for sale and do not generate any revenue from product sales. Accordingly, until we begin to generate revenue from product sales, if any of our product candidates are approved, we expect to rely primarily on equity and/or debt financings or other non-dilutive sources of capital to fund our continued operations. Our ability to raise additional funds will depend, in part, on the success of our nonclinical studies and clinical trials and other product development activities, regulatory events, our ability to identify and enter into licensing or other strategic arrangements, and other events or conditions that may affect our value or prospects, as well as factors related to financial, economic and market conditions, many of which are beyond our control. For example, even if our clinical trials generate data that we view favorably, investors may not share our interpretation of these data, and we may be unable to raise additional funds. There can be no assurances that sufficient funds will be available to us when required or on acceptable terms, if at all.

If we are unable to raisesecure additional capital when required or on acceptable terms, we may be required to:

We have no products approved for commercialization and have never generated any revenue from product sales. Our ability to generate revenue and achieve profitability depends on our ability, alone or with strategic collaborators, to successfully complete the development of, obtain the regulatory and marketing approvals, and build and maintain a commercial supply chain necessary to commercialize one or more of our product candidates. We do not anticipate generating revenue from product sales foruntil theour foreseeableproduct future.candidates Ourreceive marketing authorization, if ever. Even if we receive such authorization, our ability to generate future revenue from product sales depends heavily on our success in many areas, including but not limited to:

•our ability to avoid or defend third-party patent infringement claims;

Until such time, if ever, as we can generate substantial revenue from the sale of our product candidates, we expect to finance our cash needs through a combination of equity offerings, debt financings, and license and development agreements. To the extent that we raise additional capital through the sale of equity securities or convertible debt securities, or other non-dilutive sources of capital, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, making additional product acquisitions, or declaring dividends.

If we raise additional fundscapital through collaborations, strategic alliances or marketing, distribution, or licensing arrangements with third parties, we may be required to relinquish valuable rights to our research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional fundscapital through equity or debt financings or other arrangements with third parties when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to third parties to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

To the extent that we raise additional capital through the sale of equity, including pursuant to any sales under our SeptemberMarch 20222025 ATM Agreement with Jefferies,Jefferies LLC (“Jefferies”), convertible debt, or other securities convertible into equity, the ownership interest of our stockholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Any additional sales of our capital stock by us will dilute the ownership interest of our stockholders and may cause the price per share of our common stock to decrease. In addition, any exercise of outstanding warrants will dilute the ownership interest of our stockholders and may cause the price per share of our common stock to decrease. Debt financing, including under our Hercules Loan and Security Agreement, and other arrangements, such as the DRI Purchase and Sale Agreement, may include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, making additional product acquisitions, or declaring dividends.

Clinical development is expensive, time consuming, and involves significant risk. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. A failure of one or more clinical trials can occur at any stage of development. Events that may prevent successful or timely completion of clinical development plan include but are not limited to:

•geopolitical unrest and adverse regulatory or other actions taken against us, or third parties on whom we relay,rely, by foreign governments or entities, including in Israel and China, where we have current or planned clinical trial operations;

We expect that the THRIVE and THRIVE-2 phase 3 clinical trials, together with a safety database comprising 300 treated patients (safety database inclusive of THRIVE and THRIVE-2 patients), will support global health authority registration for veligrotug for marketing approval in both active and chronic TED, respectively. However, the FDA or other regulatory authorities may require additional patients in this safety database or may require us to take other additional steps. We are also conducting a global pivotal program for VRDN-003. We may be required to take other additional steps in the course of development and regulatory interaction regarding our product candidates, including veligrotug, VRDN-003,elegrobart, VRDN-006 and VRDN-006.VRDN-008. Such additional steps may include, without limitation, initiating new trials, starting at an earlier phase of clinical trial, conducting bridging studies, enrolling more patients, amending trial protocols, or requiring us to assess additional parameters related to safety or efficacy. For example, we may make adjustments to the VRDN-003elegrobart clinical trial designs as a result of the additional data or feedback from regulatory authorities. These additional requirements or steps could increase the cost of development of our product candidates, negatively affect our anticipated timelines, delay our time to market with our product candidates, if approved, and could harm our business.

The FDA or other regulatory authorities may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or non-compliance with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks;risks, or imposition of distribution restrictions or other restrictions, for example, under a Risk Evaluation Mitigation Strategy (“REMS”) program. Other potential consequences include, among other things:

Any regulatory approvals that we receive for our product candidates may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the marketed product. We will be required to report adverse reactions and production problems, if any, to the FDA, EMA, and any relevant comparable foreign regulatory authorities. Any new legislation could result in delays in product development or commercialization, or increased costs to assureensure compliance. If our original marketing approval for a product candidate was granted accelerated approval by the FDA, we could be required to conduct a successful post-marketing clinical trial in order to confirm the clinical benefit of our products. Other regulatory authorities outside of the U.S. may have similar requirements. An unsuccessful post-marketing clinical trial or failure to complete such a trial could result in the withdrawal of marketing approval. We and any of our suppliers or collaborators, including our CDMOs, would be subject to periodic inspections by the FDA, EMA, and, as applicable, comparable foreign regulatory authorities to monitor compliance with cGMPs and other FDA, EMA, and, as applicable, any comparable foreign regulatory requirements. Application holders must further notify the FDA, and any comparable foreign regulatory authorities, as applicable, and depending on the nature of the change, obtain FDA pre-approval or pre-approval from other comparable foreign regulatory authorities, as applicable, for product and manufacturing changes.

We must comply with requirements concerning advertising and promotion for any product candidates for which we seek or obtain marketing approval. Promotional communications with respect to drugs and biologics are subject to a variety of legal and regulatory restrictions by the FDA and comparable foreign regulatory authorities.authorities as well as industry codes of conduct. When the FDA or comparable foreign regulatory authorities issue regulatory approval for a product candidate, the regulatory approval is limited to those specific uses and indications for which a product is approved. If we are not able to obtain FDA or comparable foreign regulatory authority approval for desired uses or indications for our product candidates, we may not market or promote them for those indications and uses, and our business, financial condition, results of operations, prospects and reputation may be materially harmed. We also must sufficiently substantiate any claims that we make for our products, including claims comparing our products to other companies’ products, and must abide by the FDA or comparable foreign regulatory authority’s strict requirements regarding the content of promotion and advertising.

Any government investigation or enforcement actionaction, including by governments or trade associations, concerning alleged violations of law, regulations, or industry codes of conduct, including with respect to promotional requirements, would be expected to require us to expend significant time and resources in response and could result in significant liability, including civil and administrative remedies as well as criminal sanctions and fines. Even if it is later determined that we were not in violation of these laws, regulations, or industry codes of conduct, we may be faced with negative publicity, incur significant expenses defending our actions and have to divert significant management resources from other matters. Any non-compliance with ongoing regulatory requirements may significantly and adversely affect our ability to develop and commercialize our products, and the value of the company and our operating results would be adversely affected.

The FDA and other regulatory authorities have substantial discretion in the approval process, including determining when or whether regulatory approval will be obtained for a product candidate. Even if we believe the data collected from clinical trials are promising, such data may not be sufficient to support approval by the FDA or any other regulatory authority or such authorities may request additional information that may be difficult to generate or provide. Further, following approval, the FDA or other regulatory authorities may conduct additional inspections and, based on the results of such inspections, deem the inspected manufacturing facilities to be deficient, suspending our ability to manufacture our product candidates until we can secure satisfactory alternative manufacturing facilities. Additionally, giventhe ability of the secondFDA Trumpto Administrationreview and theapprove prospectnew ofproducts, potentialto downsizing,provide reformingfeedback on clinical trials and restructuringdevelopment of federal health agencies, there may be substantial loss of key FDA staff. If there are significant gaps in subject matter expertise, FDA may not be ableprograms, to meet certainwith timelines,sponsors and to otherwise review regulatory submissions can be affected by a variety of factors, including government budget and approvalfunding levels; the ability to hire and retain key personnel and accept the payment of user fees; and statutory, regulatory, and policy changes, among other factors. Average review times have fluctuated in recent years as a result. Delays at the FDA as a result of these or other factors could impact the FDA’s ability to act on our BLA submission for veligrotug by the PDUFA target action date of June 30, 2026, or any of our other regulatory submissions to the FDA may be delayed or extended.submissions.

In addition to the United States,U.S., we mayanticipate seeking regulatory approval to commercialize our product candidates in Europe and, in January 2026, we submitted an MAA to the EMA to seek regulatory approval to commercialize veligrotug in Europe. We also anticipate that our partners (or their sublicensees) to whom we have licensed our anti-IGF1R antibodies will seek regulatory approval to commercialize our product candidates in Europe.their territories, including in Greater China and Japan. While the scope of regulatory approval is similar in many countries, to obtain separate regulatory approval in multiple countries will require us and our partners to comply with numerous and varying regulatory requirements of each such country or jurisdiction regarding safety, efficacy and quality, and governing, among other things, clinical trials, commercial sales, pricing and distribution, and we cannot predict success in any such jurisdictions, even if we were to receive approval in the United States.U.S.

The process of obtaining regulatory approvals, both in the United StatesU.S. and in other countries, is time consuming, expensive, may take many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted BLA, or equivalent application types, may cause delays in the approval or rejection of an application.

Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional nonclinical studies or clinical or other trials for our current or future product candidates. Our current and future product candidates could be delayed in receiving, or fail to receive, regulatory approvalapproval, including current and future product candidates that have been licensed to our partners. We or our partners to whom we have granted licenses may fail or cease to advance theirthe development of our current and future product candidates for many reasons, including the following:

•the results of clinical trials may produce negative, inconclusive or uncompetitive results, which may result in us deciding, or regulatory authorities requiring us, to conduct additional clinical trials or analyses or to modify or cease development programs for our product candidates;

•the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a BLA, supplementary BLA or other submission or to obtain regulatory approval in the United StatesU.S. or elsewhere;

•regulatory authorities may require additional warnings on the drug labeling or narrow approved indications;

•our reputation and the commercial success of our products may suffer.

Clinical trials by their nature utilize a sample of the potential patient population. But, withWith a limited number of subjects and limited duration of exposure, we cannot be fully assured that rare and severe side effects of our product candidates will be uncovered.uncovered and whether the real world safety and effectiveness of a product candidate will be consistent with the safety and effectiveness profile seen in clinical studies. Such rare and severe side effects may only be uncovered with a significantly larger number of patients or subjects exposed to the drug. IfNew suchdata safetyrelating problemsto occurveligrotug, including from adverse events reports and any potential post-marketing commitments or arerequirements identifiedin afterthe United States, and from other ongoing clinical studies, including those of our productpartners, candidatesmay reachresult in changes to the market,product labeling and may adversely affect sales, or result in withdrawal of veligrotug from the market. The FDA or otherand regulatory authorities in other jurisdictions may requirealso that we amendconsider the labelingnew ofdata thein product,reviewing implementveligrotug’s amarketing REMS,applications recallfor theadditional product,indications conduct a post-approval study and/or studies,in implementother surveillance measures,jurisdictions, or may evenimpose withdrawpost-approval approvalcommitments foror therequirements. product.If Laterany discoveredof undesirablethese sideactions effectswere to occur, it could further result in reducedsignificant market acceptanceexpense and utilizationdelay ofand/or limit our productability orto potentialgenerate productsales liability claims. Any of these occurrences may materially harm our business, financial condition, results of operations and prospects.revenues.

Some of our product candidates, including VRDN-003,elegrobart, VRDN-006 and VRDN-008, are or are anticipated to be combination products that will require coordination within the FDA and similar foreign regulatory agencies for review of their device and drug components. Although the FDA and similar foreign regulatory agencies have systems in place for the review and approval of combination products, such as drugs that utilize delivery systems like auto-injectors or prefilled syringes, we may experience delays in the development and commercialization of our product candidates due to complexities arising from them being combination products and associated regulatory timing constraints and uncertainties in the product development and approval process. Of note, prior clearance or approval of one component of a combination product does not increase the likelihood that the FDA will approve a later product combining the previously cleared product or approved active ingredient with a novel active ingredient. See “Business—Government Regulation—Regulation of Combination Products.”

From time to time, we publish preliminary data from our clinical trials. OnIn December 18, 2023, we reported clinical data from our phase 1 clinical study in healthy volunteers and announced the selection of VRDN-003elegrobart as our lead subcutaneous product candidate for TED. Based on the comparable pharmacology of VRDN-003elegrobart to veligrotug, we believe VRDN-003elegrobart has the potential to maintain the clinical response of veligrotug while significantly increasing patient convenience. However, we are conducting a global pivotal program for VRDN-003elegrobart in patients with TED, and results of any clinical trials conducted in TED patients with VRDN-003elegrobart may not demonstrate safety or efficacy comparable to veligrotug or at all.

OnIn September 10, 2024, we announced topline data from the phase 3 THRIVE trial of veligrotug in patients with active TED. OnIn December 16, 2024, we announced topline data from the phase 3 THRIVE-2 trial in patients with chronic TED. While THRIVE and THRIVE-2 met all primary and secondary endpoints at 15 weeks with a generally well-tolerated safety profile, this data may not be fully reflective of the final results for the THRIVE and THRIVE-2 trials, respectively. If final results from the THRIVE and THRIVE-2 trials are not positive or favorable, it could negatively impact or alter the development of veligrotug and could materially harm our business prospects. If clinical data from the veligrotug trials are not positive or favorable, it could negatively impact or alter the development of VRDN-003elegrobart and could materially harm our business prospects. Similarly, negative or unfavorable clinical data from our VRDN-003elegrobart product candidate could negatively impact veligrotug and could materially harm our business prospects.

Topline or preliminary data from our clinical trials that we announce or publish from time to time, including the data from our phase 1 study in healthy volunteers, the data for veligrotug from our ongoing trials, and topline data may change as more patient data become available and we become subject to audit and verification procedures that could result in material changes in the final data. The final results of clinical trials may include additional outcome measurements made throughout the duration of the clinical trial. This creates a risk that the final results could be materially different from the preliminary results reported, including those reported to date.date, and may include additional outcome measurements made throughout the duration of the clinical trial that are not positive or favorable. Additionally, differences in patient populations across our clinical trials may lead to inconsistent or unrepresentative data.

SignificantNegative or unfavorable additional outcome measurements made throughout the duration of a clinical trial or significant adverse differences between preliminary data and final, audited and verified data could negatively affect the prospect of regulatory approval for our product candidates and could materially harm our reputation and business prospects.

We may attempt to form collaborations in the future with respect to our product candidates, but we may not be able to do so, which may cause us to alter our development and commercialization plans. Even where we have entered into a collaboration, they may not be successful.

Even ifwhere we arehave able to successfully enterentered into a license agreement or other form of collaboration regarding the development or commercialization of our product candidates, including those with Zenas Biopharma or Kissei, we cannot guarantee that such a collaboration will be successful. Any delays in identifying suitable collaborators and entering into agreements to develop and/or commercialize our product candidates could delay the development or commercialization of our product candidates, which may reduce their competitiveness even if they reach the market. Absent a strategic collaborator, we would need to undertake development and/or commercialization activities at our own expense. If we elect to fund and undertake development and/or commercialization activities on our own, we may need to obtain additional expertise and additional capital, which may not be available to us on acceptable terms or at all. If we are unable to do so, we may not be able to develop our product candidates or bring them to market and our business may be materially and adversely affected.

The development and commercialization of new drug products is highly competitive, particularly in the treatment of TED and FcRn inhibitor therapeutics. We face competition from major pharmaceutical companies, specialty pharmaceutical companies, biotechnology companies, universities, and other research institutions worldwide with respect to our product candidates. We are aware that the following companies, among others, have therapeutics marketed or in development for TED: Amgen, Argenx, Immunovant, Inc., Roche Holdings AG, Alumis, Inc. (merged with ACELYRIN, Inc.,Inc. in May 2025), Tourmaline Bio, Inc., Lassen Therapeutics, and Sling Therapeutics, Inc. Other companies such as Kriya Therapeutics, Inc., Septerna and Crinetics Pharmaceuticals, Inc. among others, have earlier stage products in development which, if successfully developed, may impact the value of our product candidates over their lifecycle. If approved, veligrotug and VRDN-003elegrobart will also compete against generic medications, such as corticosteroids, and surgical procedures that are prescribed for the treatment of TED. We are also aware that the following companies, among others, may have anti-FcRn therapeutics marketed or in development: Argenx, UCB S.A., Johnson & Johnson,Johnson and Immunovant, Inc. and AstraZeneca. Moreover, there are more than 20 indications announced or in development across the FcRn class. Depending on the indications in which we choose to develop VRDN-006 and VRDN-008, there may be further competition from marketed and in-development therapeutics targeting other mechanisms such as complement inhibition, T-cell inhibitors, anti-1L-6 and other mechanisms of action.

This section discusses 20242025 and 20232024 items and year-to-year comparisons between the years ended December 31, 2025 and 2024. Discussions of the year ended December 31, 2023 and year-to-year comparisons between the years ended December 31, 2024 and 2023. Discussions of the year ended December 31, 2022 and year-to-year comparisons between the years ended December 31, 2023 and 2022 have been excluded from this Form 10-K and can be found in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023,2024, filed with the SEC on FebruaryMarch 27,3, 2024.2025.

We are a biopharmaceutical company focused on discovering, developingdeveloping, and commercializing potential best-in-class medicines for serious and rare diseases. We target diseasetherapeutic areas wherein marketedwhich therapiescurrent oftentreatments leave room for improvements in efficacy, safety, and/or dosing convenience. We believe that first-generation medicines rarely represent optimal solutions, especially in rare disease areas, and that there is significant potential in these areas for better medicines that address unmet needs, improve outcomes, and expand treatment options for patients. We aim to develop differentiated, potential best-in-class medicines that could lead to improved patient outcomes, reduced side effects, improved quality of life, and expanded market access, and augmented market competition. Our business model is designed to identify and evaluate product opportunities in disease areas where trial data establishes proof-of-concept for a drug target in the clinic, but the competitive evolution of the product life cycle management and number of entrants appears incomplete. We intend to prioritize indications where a fast-follower and a potentially differentiated drug candidate, or overall product profile, could create significant medical benefit for patients. We are engineering product candidates to address unmet medical needs for patients and further advance drug innovation.access.

Our approachstrategy combines clear scientific, clinical, and commercial rationale with excellence in execution to rapidly discoveringdiscover, develop, and developingcommercialize novelbetter therapeuticsmedicines reliesfor patients. We rely on our scientificscientific, clinical, and commercial expertise into evaluating pre-existing clinical proof-of-concept data for the drug targets we are pursuing, andidentify opportunities to improve upon existing investigational and/or approved therapies. This approach informs how we design, select,therapies and developto ourapply these insights to designing, selecting, developing, and commercializing potential best-in-class product candidates,candidates. includingWe inbring potential improvements to critical areas such as molecular design, dose selection, pharmacokinetics, pharmacodynamics, clinical trial design, trial endpoints, and the selection and recruitment of patients. We believe this strategy enables efficient product development and reduces the risksrisk associated with discovering andwhen developing novel therapeutics.

Development of IGF-1R Therapies to Treat Thyroid Eye Disease (TED)

We are developing two anti-IGF-1R product candidates, veligrotug for intravenous (“IV”) administration and elegrobart (formerly known as VRDN-001VRDN-003) for intravenoussubcutaneous and VRDN-003 for subcutaneous(“SC”) administration, to treat patients who suffer from TED. Our most advanced program, veligrotug, is a differentiated humanized monoclonal antibody targeting IGF-1R intravenously administered for the treatment of TED. In previously presented in vitro nonclinical data, we showed that veligrotug is a potentially differentiated full antagonist of IGF-1R, compared to teprotumumab’s incomplete antagonism of IGF-1R. VRDN-003Elegrobart has the same binding domain as veligrotug, and was engineered to have a longer half-life. VRDN-003Elegrobart is designed to be a low-volume, infrequently-dosed subcutaneous IGF-1R for TED, which we plan to launch commercially with an auto-injector to enable at-home patient self-administration. We believe VRDN-003elegrobart has the potential to be the best-in-class subcutaneous anti-IGF-1R product candidate by preserving the efficacy of anti-IGF-1Rs in TED, improving safetysafety, and maximizing convenience for patients.patients with subcutaneous delivery.

We are conductingconducted a global pivotal clinical program for veligrotug, including evaluating its efficacy and safety in two global well-controlled phase 3 clinical trials, THRIVE and THRIVE-2, for the treatment of active and chronic TED, respectively. THRIVE and THRIVE-2 arewere each designed to compare a five-dose IV treatment arm of veligrotug at 10 mg/kg, dosed three weeks apart, to placebo. This five-dose veligrotug regimen features fewer infusions and a shorter time per infusion compared to teprotumumab, the currently marketed IGF-1R inhibitor. OnIn September 10, 2024, we announced topline data from the THRIVE study, which enrolled 113 patients, randomized to veligrotug (n=75) and placebo (n=38). THRIVE achieved allits primary and all secondary endpoints with a high level of statistical significance (p < 0.0001) and was generally well-tolerated, with no treatment-related serious adverse events (“SAEs”). Veligrotug additionally showed a rapid onset of treatment effect, with the majority (53%) of veligrotug-treated patients achieving a proptosis response as early as three weeks. OnIn December 16, 2024, we announced topline data from the THRIVE-2 study, which enrolled 188 patients, randomized to veligrotug (n=125) and placebo (n=63). THRIVE-2 achieved allits primary and all secondary endpoints with statistical significance and was generally well-tolerated. Veligrotug continued to demonstratedemonstrated a rapid onset of treatment effect,effect in THRIVE-2, with a statistically significant proptosis response as early as three weeks and a statistically significant reduction and resolution of diplopia as early as six weeks. THRIVE-2 is the first global phase 3 study in patients with chronic TED to demonstrate a statistically significant and clinically meaningful diplopia responder rate and rate of diplopia complete resolution. ToVeligrotug meetdemonstrated thedurability 300at patient52 standardweeks safetyin databaseTHRIVE, requirementsshowing forthat the veligrotug biologics license application (“BLA”), we are conducting our STRIVE clinical trial (safety database inclusive70% of patients fromwho thewere THRIVEproptosis andresponders THRIVE-2at trials).week STRIVE15 ismaintained atheir globalresponse studyat ofweek veligrotug in TED patients that utilizes broad inclusion criteria (e.g., any severity or duration of disease) and is randomized 3:1 (10 mg/kg IV with an active control of 3 mg/kg IV). In January 2025, we completed enrollment in STRIVE with a total of 231 patients, exceeding the enrollment target of 212 due to patient demand. We have also completed enrollment of the open label extension study for non-responding patients in THRIVE and THRIVE-2. We anticipate submitting a BLA for veligrotug in the second half of 2025 and an MAA to the EMA in the first half of 2026.52.

InWe additionare toalso ourdeveloping intravenous veligrotug program, VRDN-003 iselegrobart, our subcutaneous anti-IGF-1R product candidate currently in pivotal developmentclinical studies in TED, which we selected in December 2023 following positive data in a phase 1 clinical trial in healthy volunteers.

We are conducting a global pivotal program for VRDN-003,elegrobart, including evaluating its efficacy and safety in two global well-controlled phase 3 clinical trials, REVEAL-1 and REVEAL-2, for the treatment of active and chronic TED, respectively. Both studies willare evaluateevaluating subcutaneous VRDN-003elegrobart administered subcutaneously every four weeks or every eight weeks and will assess outcomes versus placebo. PatientIn enrollmentSeptember 2025, we announced that REVEAL-1 and dosingREVEAL-2 continuescompleted inenrollment, bothenrolling studies.132 and 204 patients, respectively, each exceeding its target enrollments of 117 and 195 patients, respectively, due to demand. 67% of REVEAL-1 patients were enrolled from the U.S., and 56% of REVEAL-2 patients were enrolled from the U.S. In addition, to enable BLA submission for VRDN-003,elegrobart, we haveare initiatedconducting a safety study to meet the 300 patient standard safety database requirement (to also include patients from the REVEAL-1 and REVEAL-2 trials). andWe plancompleted enrollment of this safety study in October 2025, enrolling 321 patients, exceeding the target enrollment of 284 patients due to initiatedemand. Additionally, we are conducting an auto-injector study in 2025 to enable launching VRDN-003elegrobart in an auto-injector device, if approved. We completed enrollment in the autoinjector study in December 2025, enrolling 87 patients, exceeding the target enrollment of 75 patients. We anticipate topline data for REVEAL-1 in the first quarter of 2026 and REVEAL-2 in the firstsecond half of 2026, and we anticipate submitting a BLA for VRDN-003 for the treatment of TED by the endquarter of 2026.

In addition to developing therapies for TED, weWe are also developing a portfolio of engineered FcRn inhibitors, including VRDN-006 and VRDN-008. FcRn inhibitors have the potential to treat a broad array of autoimmune diseases, representing a possible significant commercial market opportunity. Our multi-pronged engineering approach has resulted in a portfolio of FcRn-targeting molecules that leverage the clinically and commercially validated mechanism of FcRn inhibition while potentially addressing the limitations of current agents such as incomplete immunoglobulin G (“IgG”) suppression, safety, and inconvenience of dosing.

VRDN-006 is a highly selective Fc fragment that inhibits FcRn and is designed to be a convenient subcutaneous and self-administered option for patients. In non-human primate (“NHP”) studies, VRDN-006 demonstrated specificity for blocking FcRn-IgG interactions while not showing decreases in albumin or increases in low-density lipoprotein (“LDL”) levels, which are known potential side effects associated with certain full-length anti-FcRn monoclonal antibodies. In our head-to-head NHP studies, VRDN-006 demonstrated comparable potency and IgG reductions to efgartigimod, which is the current standard of care in FcRn inhibition, as well as a similar safety profile. We submitted an Investigational New Drug Application (“IND”) for VRDN-006 in December 2024, which cleared in January 2025. In September 2025, and we expectannounced proof-of-concept IgG reductionthat data from an ongoing phase 1 clinical trial in healthy volunteers inshowed that VRDN-006 led to IgG reductions that are consistent with the thirdFcRn quarterinhibitor class, and that VRDN-006 was sparing of 2025.albumin and LDL and was generally well-tolerated with no dose-limiting toxicities or serious adverse events.

VRDN-008 is a half-life extended bispecific FcRn inhibitor comprising an Fc fragment and an albumin-binding domain designed to prolong IgG suppression and provide a potentially best-in-class subcutaneous option for patients. In a single, high-dose, head-to-head study in NHPs, VRDN-008 demonstrated three times the half-life of efgartigimod. Additionally, VRDN-008 showed a deeper and more sustained IgG reduction with peak IgG reductions that were 20% deeper than efgartigimodefgartigimod, whileand notIgG showinglevels decreasesreturned into baseline 35 days after VRDN-008 dosing, more than twice as long as efgartigimod, which returned to baseline 14 days after dosing. VRDN-008 spared albumin or increases in LDL levels. NHP studies are ongoing to generate additional data for VRDN-008. Once completed, we plan to use the totality of VRDN-008’s NHP data to build a robust pharmacokinetic and pharmacodynamicLDL, modelconsistent towith predict potential human dosing regimens for VRDN-008.efgartigimod. We anticipate submittingsubmitted an IND for VRDN-008 byin December 2025 and received IND clearance from the endFDA in January 2026. We expect healthy volunteer data in the second half of 2025.2026.

In October 2020, we becameentered party tointo a license agreement with Zenas BioPharma. Since February 2021,Subsequently, we have entered into several letter agreements with Zenas BioPharma in which we agreed to provide assistance toassist Zenas BioPharma with certain development activities, including manufacturing (collectively with the license agreement, the “Zenas Agreements”). Under the terms of the Zenas Agreements, we granted Zenas BioPharma an exclusive license to develop, manufacture, and commercialize certain IGF-1R directed antibody products for non-oncology indications in the greater area of China in exchange for upfront non-cash consideration and non-refundable milestone payments upon achieving specific milestone events during the contract term. In July 2022, Zenas BioPharma announced that it had obtained IND approval in China in July 2022. Under the license agreement, we received a $1.0 million milestone payment from Zenas BioPharma.China. Additionally, we are eligible to receive royalty payments based on a percentage of the annual net sales of any licensed products sold on a country-by-country basis in the greater area of China.China throughout the royalty term. The royalty percentage may vary based on different tiers of annual net sales of the licensed products made. Zenas BioPharma is obligated to make royalty payments to us for the royalty term in the Zenas Agreements. In May 2022, we entered into a Manufacturingmanufacturing Developmentdevelopment and Supplysupply Agreementagreement with Zenas BioPharma to manufacture and supply, or have manufactured and supplied, clinical drug product for development purposes. In January 2025, Zenas BioPharma sublicensed their rights under the license agreement to Zai Lab and assigned the Manufacturingmanufacturing Developmentdevelopment and Supplysupply Agreementagreement to Zai Lab in connection with the sublicense transaction. In July 2025, the Company entered into a side agreement with Zai Lab (the “Side Agreement”), with Zenas BioPharma as countersigner, pursuant to which the Company agreed to provide certain services directly to Zai Lab to support development and commercialization activities. In August 2025, the Company entered into a material transfer agreement (“MTA”) with Zai Lab, to supply certain materials for clinical trial use. We have concluded that Zenas Biopharma and Zai Lab are related parties to us.

In the future, we expect to continue to generate revenue from a combination of license fees and other up-frontupfront payments, payments for research and development services, milestone payments, product sales, and royalties in connection with strategic alliances.alliances and from customers. We expect that any revenue we generate could fluctuate from quarter to quarter as a result of the timing of our achievement of development and commercial milestones, the timing and amount of payments relating to such milestones and the extent to which any of our product candidates are approved and successfully commercialized by us or our strategic alliance collaborators, if any. If we or our strategic alliance collaborators, if any, fail to develop product candidates in a timely manner or to obtain regulatory approval for them, then our ability to generate future revenue, and our results of operations and financial position would be adversely affected.

We record up-frontupfront and milestone payments to acquire and retain contractual rights to in-licensed technology and intellectual property rights as research and development expenses when incurred if there is uncertainty in our receiving future economic benefit from the acquired contractual rights. We consider future economic benefits from acquired contractual rights to licensed technology to be uncertain until such a drug candidate is approved by the FDA or other regulatory authorities, or when other significant risk factors are abated.

Successful development of future product candidates is highly uncertain and may not result in approved products. Completion dates and completion costs can vary significantly for each future product candidate and are difficult to predict. We anticipate we will make determinations as to which programs to pursue and how much funding to direct to each program on an ongoing basis in response to our ability to maintain or enter into new strategic alliances with respect to each program or potential product candidate, the scientific and clinical success of each future product candidate, and ongoing assessments as to each future product candidate’s commercial potential. We willmay need to raisesecure additional capital and maycould seek additional strategic alliances in the future in order to advance the various clinical trials that are part of our clinical development program described above.

Selling, General and Administrative Expenses

GeneralSelling, general and administrative expenses consist primarily of salaries and related benefits, including share-based compensation, and severance and retention benefits related to our executive, commercial, finance, accounting, human resources, legal, business development, and other support functions, professional fees for auditing, tax, and legal services, market research and other professional and consulting fees to prepare for commercial activities, as well as insurance, board of director compensation, consulting, and other administrative expenses.

Other Income,Income (Expense), net

Other income,income (expense), net consists primarily of interest income, netinterest of fees,expense and various income items of a non-recurring nature. We earn interest income from interest-bearing accounts, money market funds and marketable securities. Interest expense consists of cash and non-cash interest expense onrelated to our long-termDRI debt. We earn interest income from interest-bearing accounts, money market funds,Purchase and short-termSale investments.Agreement and Hercules Loan and Security Agreement.

This discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses. On an ongoing basis, we evaluate these estimates and judgments. We base our estimates on historical experience and on various assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially from these estimates. We believe that the accounting policypolicies discussed below isare critical to understanding our historical and future performance, as thisthese policypolicies relatesrelate to the more significant areas involving our judgments and estimates.

RevenueLicense revenue for the year ended December 31, 2025 was $0.3attributable millionto the collaboration and license agreement with Kissei. Collaboration revenue - related parties for the years ended December 31, 20242025 and 2023. Revenue for both periods2024 was attributable to our collaboration agreement with Zenas BioPharma.BioPharma and the Side Agreement and MTA with Zai Lab.

Direct costs related to the TED portfolio increased by $59.5$78.3 million during the year ended December 31, 20242025 compared to the year ended December 31, 2023,2024, primarily attributabledriven toby the progression of our portfolio, including the following:

•$50.5$55.6 million increase in clinical trial costs and aan $10.9$8.7 million increase in chemistry, manufacturing and controls costs to support themultiple ongoing phase 3 clinical trials for veligrotug and VRDN-003elegrobart clinical trials.trials; and

•$5.7$11.4 million decreaseincrease in milestone, license and option fees asdue aunder result of an upfront payment for an exclusiveour license and collaboration agreement duringwith the year ended December 31, 2023;ImmunoGen.

Personnel-relatedDirect costs related to the FcRn inhibitor portfolio increased $15.6by $4.5 million during the year ended December 31, 20242025 compared to the year ended December 31, 2023,2024, primarily attributable to:

FacilityDirect costs related to other nonclinical research and other operating costsdevelopment increased $1.9by $4.0 million during the year ended December 31, 20242025 compared to the year ended December 31, 2023,2024, primarily attributable to an increase in professionalnonclinical services fees for consultantsresearch and contractors,chemistry, as well as an increase in facilitymanufacturing and information technologycontrols costs to support our ongoing research andthe development efforts.of the TSHR program.

GeneralPersonnel-related andcosts administrativeincreased expenses were $61.1$14.3 million during the year ended December 31, 2024,2025 compared to $95.0 million during the year ended December 31, 2023. The $33.9 million decrease in general and administrative expenses is2024, primarily attributable to theincreased following:headcount to support our ongoing research and development efforts.

We are a commercial stage biopharmaceutical company with a limited operating history. We have historically incurred net losses. During the threesix months ended MarchJune 31,30, 2026,2026 and 2025, our net loss was $104.9$232.0 million and $86.9$187.6 million, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $1,443.4$1,570.5 million and cash, cash equivalents and marketable securities of $762.2$981.5 million.

We may need to secure substantial additional capital to continue to fund our operations in the future. The amount and timing of our future funding requirements will depend on many factors, including the pace, results and costs of our clinical development efforts, our ability to generate revenues from sales of veligrotug andand, if elegrobart in the U.S., ifis approved, elegrobart, and macroeconomic conditions affecting our business and industry.

We have devoted substantially all of our financial resources to identifying, acquiring and developing our product candidates, including conducting clinical trials and providing selling, general and administrative support for our operations. To date, we have financed our operations primarily through the sale of equity securities, convertible promissory notes, convertible senior notes, the Hercules Loan and Security Agreement, the Kissei Agreement, and the DRI Purchase and Sale Agreement. The amount of our future net losses will depend, in part, on the rate of our future expenditures and our ability to generate product revenue and obtain funding through equity, debt financings or other non-dilutive sources of capital, or strategic collaborations. Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We expect our losses to increase as our product candidates continue advancing through clinical development and as new product candidates enter clinical trials and then advance through clinical development. We expect to invest significant funds into the research and development of our current product candidates to determine the potential to advance these product candidates to regulatory approval.

If we obtain regulatory approval to market a product candidate, ourOur future revenue will depend upon market acceptance and our ability to commercialize veligrotug, obtaining regulatory approval to market our additional product candidates, the size of any markets in which our product candidates may receive approval, and our ability to establish and maintain a commercial supply chain in each market, achieve sufficient market acceptance, pricing, coverage, and adequate reimbursement from third-party payors, and adequate market share for our current product candidatesand product candidates, including veligrotug, and additional products we may develop in thosethe markets.future. Additionally, patients and physicians may not use our products as intended, if approved, which could impact the pricing and reimbursement of our products.

•continue the manufacturing of veligrotug and our product candidates or increase volumes manufactured by third parties;

•establish and maintain a sales, marketing, and supply chain and distribution infrastructure to commercialize any products for which we may obtain marketing approval and market for ourselves;

As of MarchJune 31,30, 2026, we had $762.2$981.5 million of cash, cash equivalents and marketable securities. We expect that our current cash, cash equivalents and marketable securities will enable us to fund our planned operations for at least twelve months from the date of issuance of the consolidated financial statements included in this Quarterly Report. We may need to secure additional capital to continue to fund our operations and service our obligations in the future. If we are unable to secure additional capital when needed, we will not be able to continue as a going concern.

WeVeligrotug dois notour currentlyonly have any productsproduct approved for sale in the United States and doprior to approval, we had not generate anygenerated revenue from product sales. Accordingly, until we begin to generate sufficient revenue from productsales sales,of veligrotug or any other future products, if any of our product candidates are approved, we expect to rely primarily on equity and/or debt financings or other non-dilutive sources of capital to fund our continued operations. Our ability to raise additional funds will depend, in part, on the success of our nonclinical studies and clinical trials and other product development activities, regulatory events, our ability to identify and enter into licensing or other strategic arrangements, and other events or conditions that may affect our value or prospects, as well as factors related to financial, economic and market conditions, many of which are beyond our control. For example, even if our clinical trials generate data that we view favorably, investors may not share our interpretation of these data, and we may be unable to raise additional funds. There can be no assurances that sufficient funds will be available to us when required or on acceptable terms, if at all.

WePrior haveto nevermarketing approval of veligrotug, we had not generated any revenue from product sales and may never be profitable.

WeVeligrotug haveis noour productsonly product approved for commercializationsale and haveis neverapproved in the United States only and prior to approval we had not generated any revenue from product sales. Our ability to generate revenue and achieve profitability depends on our ability, alone or with strategic collaborators, to successfully complete the development of, obtain the regulatory and marketing approvals, and build and maintain a commercial supply chain necessary to commercialize veligrotug or one or more of our product candidates. We do not anticipate generating revenue from product sales until our product candidates receivein marketingdevelopment. authorization, if ever. Even if we receive such authorization, ourOur ability to generate future revenue from product sales depends heavily on our success in many areas, including but not limited to:

•manufacturing veligrotug and product candidates and establishing and maintaining supply and manufacturing relationships with third parties that are commercially feasible, meet regulatory requirements and our supply needs in sufficient quantities to meet market demand for veligrotug or our product candidates, if approved;

•marketing, launching, and commercializing veligrotug and product candidates for which we obtain regulatory and marketing approval, either directly or with a collaborator or distributor;

•gaining market acceptance of veligrotug and our product candidates as treatment options;

•obtaining coverage and adequate reimbursement from third-party payors and receiving and maintaining pricing for veligrotug and our product candidates that supports profitability; and

Even ifthough oneveligrotug orhas more of the product candidates that we develop isbeen approved for commercial sale, we anticipate incurring significant costs associated with commercializing veligrotug and any approvedother product candidate.candidates, if approved. Portions of our current pipeline of product candidates have been in-licensed from third parties, which make the commercial sale of such in-licensed products potentially subject to additional royalty and milestone payments to such third parties. We will also have to develop or acquire manufacturing capabilities or continue to contract with contract manufacturers in order to continue development and potential commercialization of our product candidates. For instance, if the costs of manufacturing our drug product are not commercially feasible, we will need to develop or procure our drug product in a commercially feasible manner in order to successfully commercialize a future approved product, if any.

Additionally, if we are not able to generate sufficient revenue from the sale of veligrotug or any approvedother products,products once approved, we may never become profitable.

Until such time, if ever, as we can generate substantial revenue from the sale of veligrotug or our other product candidates, we expect to finance our cash needs through a combination of equity offerings, debt financings, and license and development agreements. To the extent that we raise additional capital through the sale of equity securities or convertible debt securities, or other sources of capital, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, making additional product acquisitions, or declaring dividends.

To the extent that we raise additional capital through the sale of equity, including pursuant to any sales under our March 2025 ATM Agreement with Jefferies LLC (“Jefferies”), convertible debt, or other securities convertible into equity, the ownership interest of our stockholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Any additional sales of our capital stock by us will dilute the ownership interest of our stockholders and may cause the price per share of our common stock to decrease. In addition, any exercise of outstanding warrants will dilute the ownership interest of our stockholders and may cause the price per share of our common stock to decrease. Debt financing, including under our Hercules Loan and Security Agreement, and other arrangements, such as the DRI Purchase and Sale Agreement, may include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, making additional product acquisitions, or declaring dividends.

We cannot be assured that we will be able to obtain additional funding, if and when necessary, to fund our entire portfolio of product candidates to meet our projected plans. If we are unable to obtain funding on a timely basis, we may be required to limit our commercialization efforts for veligrotug in additional markets, delay or discontinue one or more of our development programs or the commercialization of any product candidates or be unable to expand our operations or otherwise capitalize on potential business opportunities, which could materially harm our business, financial condition, and results of operations.

In October 2025, we entered into the Purchase and Sale Agreement with DRI. In addition to the $55.0 million we received at signing, the agreement made available to us up to an additional $245.0 million in milestone payments at signing. However, these additional milestone payments are subject to satisfaction of certain conditions related to certain elegrobart clinical trials and regulatory approvals or commercial sales of veligrotug and elegrobart on or prior to a certain date. Should we not satisfy the conditions of the applicable milestones, or if we fail to meet our obligations or default under this agreement, the actual amount of additional milestone payments to us could be substantially less than the maximum amounts available thereunder. Based on our operations to date, we have achieved a milestone payment of $75.0 million and up to an additional $205$130.0 million in milestone payments remains available to us. In the event of a change of control on or prior to a certain date, the Company has the option to repurchase, and DRI may require the Company to repurchase, the revenue participation right from DRI for the multiplier amount (less payments to date).

Clinical development is expensive, time consuming, and involves significant risk. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. A failure of one or more clinical trials can occur at any stage of development. Events that may prevent successful or timely completion of clinical development planplans include but are not limited to:

We expect that the THRIVE and THRIVE-2 phase 3 clinical trials, together with a safety database comprising at least 300 treated patients (safety database inclusive of THRIVE and THRIVE-2 patients), will support global health authority registration for veligrotug for marketing approval in both active and chronic TED, respectively. However, the FDA or other regulatory authorities may require additional patients in this safety database or may require us to take other additional steps. We are also conducting a global pivotal program for elegrobart, where we expect that the REVEAL-1 and REVEAL-2 phase 3 clinical trials, together with a safety database comprising at least 300 treated patients (safety database inclusive of REVEAL-1 and REVEAL-2 patients), will support global health authority registration for elegrobart for marketing approval in both active and chronic TED, respectively. The FDA or other regulatory authorities may require additional patients in this safety database or may require us to take other additional steps. Additionally, Viridian is performing an autoinjector PK study for elegrobart to bridge bioequivalence from the vial/syringe used in the REVEAL-1 and REVEAL-2 trials and the autoinjector, with which we plan to launch commercially. However, the results may not show bioequivalence and/or global health authorities may not agree with the methodologies employed to support bioequivalence. If either of these occur, our BLA for elegrobart and/or its marketing approval may be significantly delayed or abandoned. Additionally, regulatory authorities outside of the United States may require us to conduct additional studies in order to support marketing approval of veligrotug in countries outside of the United States.

Even if we obtain regulatory approval for a product candidate, we willWe remain subject to ongoing regulatory requirements.oversight.

If any of our product candidatesWe are approved, we will be subject to ongoing regulatory oversight and requirements for veligrotug with respect to manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing clinical trials, and submission of safety, efficacy, and other post-approval information, including both federal and state requirements in the United States, and requirements of the EMA and comparable foreign regulatory authorities. If any of our other product candidates are approved, we will also remain subject to these ongoing regulatory requirements with respect to such product candidates.

Any regulatory approvals that we receive for our product candidates may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the marketed product. We will beare required to report adverse reactions and production problems, if any, to the FDA, EMA, and any relevant comparable foreign regulatory authorities. Any new legislation could result in delays in product development or commercialization, or increased costs to ensure compliance. If our original marketing approval for a product candidate was granted accelerated approval by the FDA, we could be required to conduct a successful post-marketing clinical trial in order to confirm the clinical benefit of our products. Other regulatory authorities outside of the U.S. may have similar requirements. An unsuccessful post-marketing clinical trial or failure to complete such a trial could result in the withdrawal of marketing approval. We and any of our suppliers or collaborators, including our CDMOs, would be subject to periodic inspections by the FDA, EMA, and, as applicable, comparable foreign regulatory authorities to monitor compliance with cGMPs and other FDA, EMA, and, as applicable, any comparable foreign regulatory requirements. Application holders must further notify the FDA, and any comparable foreign regulatory authorities, as applicable, and depending on the nature of the change, obtain FDA pre-approval or pre-approval from other comparable foreign regulatory authorities, as applicable, for product and manufacturing changes.

We must comply with requirements concerning advertising and promotion for veligrotug and for any product candidates for which we seek or obtain marketing approval. Promotional communications with respect to drugs and biologics are subject to a variety of legal and regulatory restrictions by the FDA and comparable foreign regulatory authorities as well as industry codes of conduct. When the FDA or comparable foreign regulatory authorities issue regulatory approval for a product candidate, the regulatory approval is limited to those specific uses and indications for which a product is approved. If we are not able to obtain or maintain FDA or comparable foreign regulatory authority approval for desired uses or indications for our product candidates, we may not market or promote them for those indications and uses, and our business, financial condition, results of operations, prospects and reputation may be materially harmed. We also must sufficiently substantiate any claims that we make for our products, including claims comparing our products to other companies’ products, and must abide by the FDA or comparable foreign regulatory authority’s strict requirements regarding the content of promotion and advertising.

The FDA and other regulatory authorities have substantial discretion in the approval process, including determining when or whether regulatory approval will be obtained for a product candidate. Even if we believe the data collected from clinical trials are promising, such data may not be sufficient to support approval by the FDA or any other regulatory authority or such authorities may request additional information that may be difficult to generate or provide. Further, following approval, the FDA or other regulatory authorities may conduct additional inspections and, based on the results of such inspections, deem the inspected manufacturing facilities to be deficient, suspending our ability to manufacture our product candidates until we can secure satisfactory alternative manufacturing facilities. Additionally, the ability of the FDA to review and approve new products, to provide feedback on clinical trials and development programs, to meet with sponsors and to otherwise review regulatory submissions can be affected by a variety of factors, including government budget and funding levels; the ability to hire and retain key personnel and accept the payment of user fees; and statutory, regulatory, and policy changes, among other factors. Average review times have fluctuated in recent years as a result. Delays at the FDA as a result of these or other factors could impact the FDA’s ability to act on our BLA submission for veligrotug by the PDUFA target action date of June 30, 2026, or any of our otherthe regulatory submissions.submissions that we may make.

Since the start of the current presidential administration in 2025, U.S. policy changes have been implemented at a rapid pace and additional changes are likely. The administration and federal government could adopt legislation, regulations, policies, or guidancesguidance that adversely affect our business or negatively impact the development, approval, and commercialization of our products, including creating a more challenging or costly environment in which to work. A federal government shutdown may result in the furlough of federal employees, reduced availability of government services, and suspension or delay of activities by key agencies that regulate, fund, or interact with our business, including the FDA, the Department of Health and Human Services, and the U.S. Patent and Trademark Office.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, in recent years including from October 1, 2025 to November 12, 2025, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. Following the reopening of the U.S. government on November 12, 2025, there was a backlog of regulatory submissions which could delay the ability of the FDA to review our regulatory submissions. Any such delays could have a material adverse effect on our business, such as delaying the FDA’s review and oversight of our product candidates and impact FDA’s ability to provide timely feedback on our development programs, including through Type C or Type D meetings or informal interactions. Additionally, reductions in workforce or other disruptions to the agency, particularly in the review or inspection divisions, could extend BLA review timelines, including for our BLA for veligrotug, delay or prevent pre-approval inspections, and limit opportunities for FDA feedback on pending applications. Further, FDA may pursue legislative, regulatory, or policy changes regarding the standards or processes for approving our product candidates that we may be unable to satisfy.

Even if one or more of our product candidates receivesreceive marketing approval, and we or others later identify undesirable side effects caused by such products, potentially significant negative consequences could result, including but not limited to:

Clinical trials by their nature utilize a sample of the potential patient population. With a limited number of subjects and limited duration of exposure, we cannot be fully assured that rare and severe side effects of our product candidates will be uncovered and whether the real world safety and effectiveness of a product candidate will be consistent with the safety and effectiveness profile seen in clinical studies. Such rare and severe side effects may only be uncovered with a significantly larger number of patients or subjects exposed to the drug. New data relating to veligrotug, including from adverse events reports and any potential post-marketing commitments or requirements in the United States,requirements, and from other ongoing clinical studies, including those of our partners, may result in changes to the product labeling and may adversely affect sales, or result in withdrawal of veligrotug from the market. The FDA and other regulatory authorities in other jurisdictions may also consider the new data in reviewing veligrotug’s marketing applications for additional indications and/or in other jurisdictions, or may impose post-approval commitments or requirements.jurisdictions. If any of these actions were to occur, it could result in significant expense and delay and/or limit our ability to generate sales revenues.

From time to time, we publish preliminary data from our clinical trials. In December 2023, we reported clinical data from our phase 1 clinical study in healthy volunteers and announced the selection of elegrobart as our lead subcutaneous product candidate for TED. In September 2024, we announced topline data from the phase 3 THRIVE-1THRIVE 1 trial of veligrotug in patients with active TED, in which veligrotug achieved a 70% proptosis responder rate at week 15. In March 2026, we announced topline data from the phase 3 REVEAL-1 trial of elegrobart in patients with active TED and in May 2026, we announced topline data from the phase 3 REVEAL-2 trial of elegrobart in patients with chronic TED. In the REVEAL-1 trial, elegrobart dosed every four weeks and every eight weeks achieved clinically meaningful 54% and 63% proptosis responder rate versus 18% placebo at week 24. In the REVEAL-2 trial, elegrobart dosed every four weeks and every eight weeks achieved clinically meaningful 50% and 54% proptosis responder rate versus 15% placebo at week 24.

In March 2026, we announced topline data from the phase 3 REVEAL-1 trial of elegrobart in patients with active TED and in May 2026, we announced topline data from the phase 3 REVEAL-2 trial of elegrobart in patients with chronic TED. This data may not be fully reflective of the final results for these trials. If final results from these trials are not positive or favorable, it could negatively impact or alter the development of veligrotug or elegrobart and could materially harm our business prospects. If clinical data from theany future veligrotug trials are not positive or favorable, it could negatively impact or alter the development of elegrobart and could materially harm our business prospects. Similarly, negative or unfavorable clinical data from our elegrobart product candidate could negatively impact veligrotug and could materially harm our business prospects.

Topline or preliminary data from our clinical trials that we announce or publish from time to time, including the data from our phase 1 study in healthy volunteers, the data for veligrotugour product candidates from our ongoing trials, and topline datadata, may change as more patient data become available and we become subject to audit and verification procedures that could result in material changes in the final data. The final results of clinical trials may include additional outcome measurements made throughout the duration of the clinical trial. This creates a risk that the final results could be materially different from the preliminary results reported, including those reported to date, and may include additional outcome measurements made throughout the duration of the clinical trial that are not positive or favorable. Additionally, differences in patient populations across our clinical trials may lead to inconsistent or unrepresentative data.

We may face liability for our products,approved if approved,products and for our product candidates, and if successful claims are brought against us, we may incur substantial liability and costs. If the use or misuse of our approved products, if any,product or product candidates harm patients or subjects, or is perceived to harm patients or subjects even when such harm is unrelated to our approved products, if any,product or product candidates, our regulatory approvals, if any, could be revoked or otherwise negatively impacted, and we could be subject to costly and damaging product liability claims. If we are unable to obtain adequate insurance or are required to pay for liabilities resulting from a claim excluded from, or beyond the limits of, our insurance coverage, a material liability claim could adversely affect our financial condition.

The use or misuse of our product candidates in clinical trials and the sale of any products for which we may obtain marketing approval exposes us to the risk of potential product liability claims. There is a risk that our approved product or product candidates may induce adverse events. If we cannot successfully defend against product liability claims, we could incur substantial liability and costs. Patients with the diseases targeted by our product candidates may already be in severe and advanced stages of disease and have both known and unknown significant preexisting and potentially life-threatening health risks. During the course of treatment, patients may suffer adverse events, including death, for reasons that may or may not be related to our product candidates. Such events could subject us to costly litigation, require us to pay substantial amounts of money to injured patients, delay, negatively impact, or end our opportunity to receive or maintain regulatory approval to market our products, or require us to suspend or abandon our commercialization efforts. Even in a circumstance in which an adverse event is unrelated to our product candidates, the investigation into the circumstance may be time-consuming or inconclusive. These investigations may delay our regulatory approval process or impact and limit the type of regulatory approvals our product candidates receive or maintain.

Although we have product liability insurance, which covers our historical clinical trials,trials and sale of commercial products, for up to $10.0$20.0 million per occurrence, up to an aggregate limit of $10.0$20.0 million, our insurance may be insufficient to reimburse us for any expenses or losses we may suffer. We will also likely be required to increase our product liability insurance coverage for any future clinical trials that we may initiate.initiate Ifor additional products we obtainmay marketingcommercialize approval for any of our product candidates, we will need to expand our insurance coverage to includein the sale of commercial products.future. There is no way to know if we will be able to continue to obtain product liability coverage and obtain expanded coverage, if we require it, in sufficient amounts to protect us against losses due to liability, on acceptable terms, or at all. We may not have sufficient resources to pay for any liabilities resulting from a claim excluded from, or beyond the limits of, our insurance coverage. Where we have provided indemnities in favor of third parties under our agreements with them, there is also a risk that these third parties could incur liability and bring a claim under such indemnities. An individual may bring a product liability claim against us alleging that one of our product candidates causes, or is claimed to have caused, an injury or is found to be unsuitable for consumer use. Any such product liability claims may include allegations of defects in manufacturing, defects in design, failure to warn of dangers inherent in the product, negligence, strict liability, and a breach of warranties. Claims could also be asserted under state consumer protection acts. Any product liability claim brought against us, with or without merit, could result in:

Risks Related to Commercialization of Our Product and Product Candidates

Our business operations and market access arrangements will beare subject to applicable healthcare regulatory laws, which, if not properly adhered to, could expose us to penalties.

Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations. These laws may constrain the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute our products, if approved. In the U.S., these laws include, but are not limited to the following, some of which areapply likelywith respect to apply only if or when we obtainthe marketing approval for aveligrotug and each product candidate we may develop in the future:

Ensuring compliance with these laws is time-consuming and costly. Ifcostly and whenwe onehave of our product candidates is approved, our compliance efforts will needhad to expand and evolve our compliance efforts in connection with commercialization of veligrotug to address laws that are newly applicable laws.to our business. Given the breadth of the laws and regulations, limited guidance for certain laws and regulations and evolving government interpretations of the laws and regulations, governmental authorities may possibly conclude that our business practices are non-compliant. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. If our operations are found to be in violation of any of the laws described above or any other government regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, imprisonment, and the curtailment or restructuring of our operations, any of which could adversely affect our business, financial condition, results of operations, and prospects.

If we are unable to establish and maintain commercial manufacturing, sales and marketing capabilities or enter into agreements with third parties to commercially manufacture, market and sell veligrotug or our product candidates, we may be unable to generate any revenue.

To successfully commercialize veligrotug and any additional products we may develop in the future, we will need to continue to invest in and develop our commercialization capabilities, including commercial manufacturing, sales and marketing capabilities, or establish and maintain arrangements with collaborators to commercialize veligrotug or any additional products. Any failure or delay in the timely development of our internal commercialization capabilities, or in entering into agreements with third parties to market or sell our product candidates could adversely impact the potential for the launch and success of our products. If commercialization collaborators do not commit sufficient resources to commercialize our future productsveligrotug and we are unable to develop the necessary marketing and sales capabilities on our own, we will be unable to generate sufficient product revenue to sustain or grow our business. We currently compete and may be competingrequired in the future to compete with companies that currently have extensive and well-funded marketing and sales operations, particularly in the markets our product candidates are intended to address. Without appropriate capabilities, whether directly or through third-party collaborators, we may be unable to compete successfully against these more established companies.

We may attempt to form collaborations in the future with respect to our product candidates,future, but we may not be able to do so, which may cause us to alter our development and commercialization plans. Even where we have entered into a collaboration, they may not be successful.

Even where we have entered into a license agreement or other form of collaboration regarding the development or commercialization of our products or product candidates, including those with Zenas Biopharma or Kissei, we cannot guarantee that such a collaboration will be successful. Any delays in identifying suitable collaborators and entering into agreements to develop and/or commercialize our products or product candidates could delay the development or commercialization of our products or product candidates, which may reduce their competitiveness even if they reach the market. Absent a strategic collaborator, we would need to undertake development and/or commercialization activities at our own expense. If we elect to fund and undertake development and/or commercialization activities on our own, we may need to obtain additional expertise and additional capital, which may not be available to us on acceptable terms or at all. If we are unable to do so, we may not be able to develop our product candidates or bring themour products to market and our business may be materially and adversely affected.

The development and commercialization of new drug products is highly competitive, particularly in the treatment of TED and FcRn inhibitor therapeutics. We face competition from major pharmaceutical companies, specialty pharmaceutical companies, biotechnology companies, universities, and other research institutions worldwide with respect to our product candidates. We are aware that the following companies, among others, have therapeutics marketed or in development for TED: Amgen, Argenx, Immunovant, Inc., Roche Holdings AG, Acelyrin,Novartis Inc.,AG, TourmalineMinghui Bio, Inc.,Pharmaceutical, Lassen Therapeutics, and Sling Therapeutics, Inc. Other companies such as Kriya Therapeutics, Inc., SepternaSepterna, Yarrow Bioscience, Inc., Ethyreal Bio, and Crinetics Pharmaceuticals, Inc. among others, have earlier stage products in development which, if successfully developed, may impact the value of our product candidates over their lifecycle. If approved, veligrotugVeligrotug and elegrobartelegrobart, if approved, will also compete against generic medications, such as corticosteroids, and surgical procedures that are prescribed for the treatment of TED. We are also aware that the following companies, among others, may have anti-FcRn therapeutics marketed or in development: Argenx, UCB S.A., Johnson & Johnson and Immunovant, Inc. Moreover, there are more than 20 indications announced or in development across the FcRn class. Depending on the indications in which we choose to develop VRDN-006 and VRDN-008, there may be further competition from marketed and in-development therapeutics targeting other mechanisms such as complement inhibition, T-cell inhibitors, anti-1L-6 and other mechanisms of action.

Many of our competitors have substantially greater financial, technical, and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations. Third-party payors, including governmental and private insurers, may also encourage the use of generic products. For example, if veligrotug is approved, itVeligrotug may be priced at a significant premium over other competitive products. This may make it difficult for veligrotug or any other future products to compete with generic products.

If approved, theThe commercial success of ourveligrotug, or any other products, if approved, particularly in the U.S., depends upon the level of market adoption by patients, payors and healthcare providers. If our products do not achieve an adequate level of market adoption for any reason, or if market adoption does not persist, our potential profitability and our future business prospects will be severely adversely impacted. The degree of market acceptance of ourveligrotug and any additional products approved in the future depends on a number of factors, including:

The pricing, as well as the coverage, and reimbursement of ourveligrotug and any other products that may be approved products,in ifthe any,future must be sufficient to support our commercial efforts and other development programs, and the availability of coverage and adequacy of reimbursement by third-party payors, including government healthcare programs, private insurers, managed care plans, and other organizations, are essential for most patients to be able to afford expensive treatments. Sales of ourveligrotug and other products that may be approved products,in ifthe any,future will depend substantially, both domestically and abroad, on the extent to which the costs of our approved products, if any, will be paid for or reimbursed by third-party payors. Government authorities and other third-party payors decide which products they will cover and establish reimbursement levels for those products. Such payors may attempt to control costs by restricting coverage, controlling utilization and limiting the amount of reimbursement for particular medications. Third party payors may take action to encourage use of other products perceived to be clinically superior or more cost effective which may limit demand for ourveligrotug products.or any additional products that may be approved in the future. Our ability to commercialize our product candidatescandidates, including veligrotug, successfully may also be adversely affected by discounts or rebates that we are required to provide in order to ensure coverage of our products and compete in the marketplace. If coverage and adequate reimbursement are not available, or are available only in limited amounts we may not be able to successfully commercialize our products.product candidates, including veligrotug, which would adversely affect our business and financial condition.

The pricing of veligrotug and our other products that may be approved productsin the future may be impacted by the pricing of other approved products, including those in the disease areas, drug class, and different drug classes in which we are commercializing our products. In addition, the prices of existing drugs (both inside and outside of the country of regulatory approval or sale) may be used as reference prices for new entrants, including in the same class, which may negatively impact the pricing of such new entrants. If the pricing of our approved products is impacted in these ways, the profitability of our products, if any, may be more difficult to achieve even if they receive regulatory approval or we may not be able to successfully commercialize our products.

We are hiring and training a commercial team and created the organizational infrastructure we believe we need to support the future commercial success of our products, if approved.veligrotug. Factors that may inhibit our efforts to maintain and further develop commercial capabilities include:

•an inability to hire and retain an adequate number of effective commercial personnel and hire additional commercial personnel in the future;

If we are not successful in establishingmaintaining an effective commercial, sales and marketing infrastructure, we will encounter difficulty in achieving, maintaining or increasing projected sales of our products, if approved, which would adversely affect our business and financial condition.

In addition, the FDA may implement regulatory, policy, or enforcement changes that materially limit our ability and that of our third-party contractors to promote our products to consumers, if our products are approved, which could materially impact our business. In September 2025, the FDA stated that it intends to more aggressively enforce requirements for direct-to-consumer, or DTC, drug advertising and sent more than 100 warning or untitled letters to companies for allegedly deceptive prescription drug advertising, which represents a dramatic increase in such actions as compared to prior years. FDA also announced plans to expand its oversight of digital and social media advertising and to initiate a rulemaking that would call for drug companies to disclose additional safety information in DTC broadcast advertisements. The nature and extent of changes to FDA’s regulations and enforcement approach is unclear but may impact pharmaceutical marketing efforts across the industry, including ours, which could in turn impact our sales and operations.

We are a biopharmaceutical company focused on discovering, developing, and commercializing potentialpotentially best-in-class medicines for seriousautoimmune and rare diseases. We target therapeutic areas in which current treatments leave room for improvements in efficacy, safety, and/or dosing convenience. We believe there is significant potential in these areas for better medicines that address unmet needs, improve outcomes, and expand treatment options for patients. We aim to develop differentiated, potential best-in-class medicines that could lead to improved patient outcomes, reduced side effects, improved quality of life, and expanded market access.

Our pipelineportfolio targets validated pathways and disease-driving mechanisms in autoimmune and rare diseases. These include our FDA-approved medicine veligrotug and product candidatescandidate elegrobart, both directed at IGF‑1R for the treatment of TED, inhibitors of theour FcRn inhibitors with potential applicationapplications across multiple autoimmune disorders, and aour TSHR inhibitor program with the potential to be developed for the treatment of TED and Graves’ disease. We develop therapeutics through internal research and discovery, as well as through in-licensing opportunities that align with our strategic focus. Our capabilities span protein and antibody discovery and engineering, biologics manufacturing, nonclinical and clinical development, commercial planning, and commercialization in these therapeutic areas.

AsIn weJune prepare2026, the FDA approved veligrotug for the anticipated launchtreatment of ourTED firstunder commercialPriority product,Review. ifIn approved,preparation for the veligrotug launch, we are buildingbuilt the infrastructure we believe is required to support a successful transition to a commercial organization. This includes establishing our capabilities in sales and marketing, market access, patient services, and commercial operations functions, and expanding our medical, clinical, regulatory, quality, and supply chain and distribution capabilities. OurFollowing approval, we launched veligrotug in the United States under the trade name Lumvoa with commercial readinesslaunch efforts focusfocused on reaching target prescribers, enabling reliable access for patients, supporting physicians,physician offices and infusion centers, and engaging effectively with payors.

Development and Commercialization of IGF-1R Therapies to Treat Thyroid Eye Disease (TED)

We are developing and commercializing therapies for the treatment of TED, a serious and debilitating rare autoimmune disease that causes inflammation within the orbit of the eye that can cause bulging of the eyes, redness and swelling, double vision, pain, and potential blindness. TED significantly impacts quality of life, imposing a high burden on activities of daily living and mental health for patients suffering from the disease. TED is a progressive disease consisting of an initial active phase (“active TED”), followed by a transition to a secondary chronic phase (“chronic TED”). The only medicine approved by the FDA for TED is Tepezza® (teprotumumab), which is an intravenously administered monoclonal antibody that targets IGF-1R. Tepezza is marketed in the United States (“U.S.”) by Amgen Inc. (“Amgen”). Amgen gained approval for Tepezza in Japan in 2024 and from the European Commission in 2025.

We are also developing elegrobart, our subcutaneous anti-IGF-1R product candidate currently in pivotal clinical studies in TED, and designed to be administered via a simple autoinjector that patients cabcan self-administer at home. In its phase 1 clinical study in healthy volunteers, elegrobart was shown to have a prolonged half-life of 40 to 50 days, which is four to five times that of veligrotug. Based on this data and the similarities between the veligrotug and elegrobart antibodies, we selected Q4W and Q8W dosing of elegrobart to advance to phase 3 pivotal studies. PK modeling showed Q4W and Q8W subcutaneous elegrobart dosing could achieve the range of modeled veligrotug exposures based on a two-infusion phase 2 TED study at 3 mg/kg and 10 mg/kg IV, once every three weeks. Both dosing regimens of veligrotug showed robust clinical activity. We are conducting a global pivotal program for elegrobart, including evaluating its efficacy and safety in two global well-controlled phase 3 clinical trials, REVEAL-1 and REVEAL-2, for the treatment of active and chronic TED, respectively. Both studies are evaluating elegrobart administered subcutaneously every four weeks (“Q4W”) or every eight weeks (“Q8W”) and assessing outcomes versus placebo.

In March 2026, we announced topline data from the REVEAL-1 study, which enrolled 132 patients, randomized 1:1:1 to elegrobart Q4W (n=44), elegrobart Q8W (n=44), and placebo (n=44). REVEAL-1 met its primary endpoint of Q4W proptosis responder rate (“PRR”) with a highly statistically significant treatment effect. Subcutaneous elegrobart given Q4W and Q8W each achieved rapid reductions in proptosis and diplopia, and at the primary analysis at 24 weeks, showed clinically meaningful PRRs of 54% and 63%, respectively, versus 18% placebo. In addition, 51% of patients treated Q4W achieved a complete resolution of diplopia versus 16% placebo. In May 2026, we announced topline data from the REVEAL-2 study, which enrolled 204 patients, randomized to elegrobart Q4W (n=70), elegrobart Q8W (n=68), and placebo (n=66). REVEAL-2 met its primary endpoint of Q4W PRR and key secondary endpoint of Q8W PRR, each with a highly statistically significant treatment effect. Subcutaneous elegrobart given Q4W and Q8W each achieved rapid reductions in proptosis and diplopia, and at the primary analysis at 24 weeks, showed clinically meaningful PRRs of 50% and 54%, respectively, versus 15% placebo. In addition, at 24 weeks, elegrobart given Q4W achieved a diplopia responder rate of 61% versus 38% placebo. We anticipate submitting a BLA for elegrobart in the first quarter of 2027.

In addition to REVEAL-1 and REVEAL-2, to enable BLA submission for elegrobart, we are conducting a safety study with elegrobart to meet the 300-patient safety database requirement (to also include patients from the REVEAL-1 and REVEAL-2 trials). We completedenrolled enrollment321 ofpatients in this safety study in October 2025, enrolling 321 patients,study, exceeding the target enrollment of 284 patients due to demand.demand, and achieved primary study completion in April 2026. Additionally, we are conductingconducted an auto-injectorautoinjector study to enable launching elegrobart in an auto-injectorautoinjector device, if approved. We completedenrolled enrollment87 patients in the autoinjector study in December 2025, enrolling 87 patients,study, exceeding the target enrollment of 75 patients.patients, and completed the study in May 2026.

In January 2026, we announced that we are developing an anti-TSHR candidate with potential use in the treatment of Graves’ disease and TED. This product candidate is a half‑life extended monoclonal antibody designed to inhibit activation of TSHR. It is being developed for subcutaneous administration via autoinjector, with the goal of enabling extended dosing intervals intended to support patient convenience. We anticipate submitting an IND for this program in the fourth quarter of 2026. We believe inhibiting TSHR has the potential to treat both TED and Graves’ disease. TED pathophysiology potentially stems from the activation of the TSHR and IGF-1R signaling complex on orbital fibroblasts, leading to hyaluronan secretion and expansion of orbital fat and muscle. Autoantibodies that stimulate TSHR can activate pathways that promote inflammation, fibroblast proliferation, and tissue remodeling relevant to TED. We believe inhibiting TSHR could complement the inhibition of IGF-1R in the treatment of TED. In addition to TED, we believe blocking TSHR could also be effective to treat Graves’ disease. Graves’ disease is an autoimmune disease in which autoantibodies form against TSHR, stimulating and activating the receptor. These TSH receptor antibodies (“TRAb”) can drive a heightened activation of TSHR, resulting in excessive thyroid hormone production and hyperthyroidism. Graves’ disease is one of the most prevalent autoimmune conditions, affecting more than 2 million people in the United States, and is the leading cause of hyperthyroidism. Current treatments—including antithyroid drugs, radioactive iodine (“RAI”),iodine, and surgery—lower thyroid hormone levels but do not entirely address the underlying autoimmune drivers of the disease and are often associated with relapse or the development of permanent hypothyroidism. Blocking TSHR activation through a TSHR antagonist represents a differentiated therapeutic approach aimed at targeting disease-driving mechanisms in TED and in Graves’ disease.

We expect that our research and development expenses willcould increase asif we expand our clinical development programs and initiate new clinical trials. The process of conducting clinical trials and nonclinical studies necessary to obtain regulatory approval is costly and time consuming. We, or our strategic alliance collaborators, if any, may never succeed in achieving marketing approval for any of our product candidates. The probability of success for each product candidate may be affected by numerous factors, including clinical data, nonclinical data, competition, manufacturability, and commercial viability of our product candidates.

Successful development of future product candidates is highly uncertain and may not result in approved products. Completion dates and completion costs can vary significantly for each future product candidate and are difficult to predict. We anticipate we will make determinations as to which programs to pursue and how much funding to direct to each program on an ongoing basis in response to our ability to maintain or enter into new strategic alliances with respect to each program or potential product candidate, the scientific and clinical success of each future product candidate, and ongoing assessments as to each future product candidate’s commercial potential. We may need to secure additional capital and could seek additional strategic alliances in the future in order to advance the various clinical trials that are part of our clinical development programprograms described above.

Selling, general and administrative expenses consist primarily of salaries and related benefits, including share-based compensation, and severance and retention benefits related to our executive, commercial, finance, human resources, legal, business development, and other support functions, professional fees for auditing, tax, and legal services, market research and other professional and consulting fees required to prepare for and to support commercial activities, as well as insurance, board of director compensation, consulting, and other administrative expenses.

Other income (expense), net consists primarily of interest income, interest expense and various items of a non-recurring nature. We earn interest income from interest-bearing accounts, money market funds, and marketable securities. Interest expense consists of cash and non-cash interest expense related to our DRI Purchase and Sale AgreementAgreement, Convertible Notes, and Hercules Loan and Security Agreement.

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

License revenue for the three months ended MarchJune 31,30, 2026 was attributable to the collaboration and license agreement with Kissei. Collaboration revenue for both the three months ended MarchJune 31,30, 2026 and 2025 was attributable to our collaboration agreement with Zenas BioPharma and the Side Agreement and MTA with Zai Lab.

Direct costs related to the TED portfolio decreased by $7.0$19.7 million during the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025, primarily driven by a decrease in clinical trial and manufacturing associated costs due to the progressiontiming and stage of our portfolio,phase including3 theclinical following:trials for veligrotug.

Direct costs related to the FcRn inhibitor portfolio decreased by $1.4$11.4 million during the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025, primarily attributabledriven toby a $1.7 million decrease in certainclinical milestonetrial paymentsand incurredmanufacturing inassociated the first quarter of 2025.costs.

Direct costs related to other nonclinical research and development increased by $6.9$12.2 million during the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025, primarily attributable to an increase in nonclinical research and chemistry, manufacturing and controlsassociated costs to support the development of the TSHR program.

Personnel-related costs increased by $3.5$5.8 million during the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025, primarily attributable to increased headcount required to support our ongoing research and development efforts.

Selling, general and administrative expenses were $38.7$55.0 million during the three months ended MarchJune 31,30, 2026, compared to $17.1$20.2 million during the three months ended MarchJune 31,30, 2025. The $21.6$34.8 million increase in selling, general and administrative expenses is primarily attributable to the following:

Other income, net was $11.3$10.4 million during the threesix months ended MarchJune 31,30, 2026 compared to $7.0$13.0 million during the threesix months ended MarchJune 31,30, 2025 primarily comprised of interest income earned on marketable securities and the change in fair value in the derivative liability, partially offset by interest expense related to our DRI Purchase and Sale AgreementAgreement, Convertible Notes, and Hercules Loan and Security Agreement.Agreement, including the loss on extinguishment of debt.

We have funded our operations to date principally through proceeds received from the sale of our common stock, our Series A convertible preferred stock, our Series B convertible preferred stock and other equity securities, debt financings, license fees, and reimbursements received under collaboration agreements. WePrior haveto nothe productsapproval approvedof forveligrotug commercialin saleJune 2026 and havethrough June 30, 2026, the Company had not generated any revenue from product sales. Since our inception and through MarchJune 31,30, 2026, we have generated an accumulated deficit of $1,443.4$1,570.5 million. Substantially all of our operating losses resulted from expenses incurred in connection with our research and development programs and from selling, general and administrative costs associated with our operations.

In addition, we may continue to incur additional operating losses as a result of planned expenditures for research and development activities, our drug development programs, including clinical trial and manufacturing costs, and the continued build-out of clinical, manufacturing, commercial, and compliance capabilities. Our ability to generate revenues from sales of veligrotugveligrotug, and elegrobartfrom insales theof U.S.,elegrobart, if regulatory approval is granted, depends on us being able to establish sales and marketing capabilities and gain acceptance in the marketplace, which we may be unable to do in a timely manner or at all. In addition, we cannot predict with any certainty whether and to what extent the timing or availability of additional funds under the DRI Purchase and Sale Agreement or the Hercules Loan and Security Agreement may be available to us. Our ability to achieve milestones under the DRI Purchase and Sale Agreement or draw down on the remaining tranches under the Hercules Loan and Security Agreement is subject to our achievement of certain regulatory and commercial milestones on or before certain dates or, for certain milestones, on mutual agreement of the applicable party.

As of MarchJune 31,30, 2026, we had $762.2$981.5 million in cash, cash equivalents and marketable securities. We expect that our current cash, cash equivalents and marketable securities will enable us to fund our planned operations for at least twelve months from the date of issuance of these unaudited condensed consolidated financial statements. Based on our current business plans, we believe that our existing cash, cash equivalents, and marketable securities, the $75.0 million in potential near-term milestones anticipated under the DRI Purchase and Sale Agreement, and the anticipated revenue from veligrotug and elegrobart sales, if each is approved on our anticipated timelines,securities will be sufficient to fund our planned operations to break even where our anticipated revenues fund our anticipated operating expenses.

In April 2022, we entered into the Hercules Loan and Security Agreement, among the Company, certain of our subsidiaries from time to time party thereto (together with the Company, collectively, the “Borrower”), Hercules and certain other lenders party thereto (the “Lenders”). Under the Hercules Loan and Security Agreement, the Lenders provided us with access to a term loan with an aggregate principal amount of up to $75.0 million, in four tranches, including an initial tranche of $25.0 million. Upon signing,signing the Hercules Loan and Security Agreement, we drew an initial principal amount of $5.0 million. Per the terms of the Hercules Loan and Security Agreement, we were originally obligated to make interest-only payments through April 1, 2024, which was extended to October 1, 2024 upon the achievement of a development milestone in August 2022.

Upon receipt of the $55.0 million payment from DRI at the close of the DRI Purchase and Sale Agreement, we recorded a liability related to the sale of future revenue of $32.4 million, net of the proportionate debt issuance costs allocated to it and the initial fair value of the bifurcated derivative liability. Following the FDA’s approval of veligrotug in June 2026, we became entitled to receive a $75.0 million milestone payment, and the Company recognized a receivable of $75.0 million, which is presented within “Other receivables” in the condensed consolidated balance sheet as of June 30, 2026. This $75.0 million milestone payment was received in July 2026. We accrued $1.8$2.6 million and $4.4 million in interest expense during the three and six months ended MarchJune 31,30, 2026. As of MarchJune 31,30, 2026, no payments of Net Sales Royalties to DRI have been made or accrued. As of MarchJune 31,30, 2026, the net carrying amount of the liability related to the sale of future revenue was $36.1$113.6 million. The imputed effective annual interest rate for the liability related to the sale of future revenue was 27.7%27.4% as of MarchJune 31,30, 2026. During the first quarter of 2026, we did not achieve certain milestones with respect to the Company’s elegrobart pivotal phase 3 clinical trials and therefore isare not eligible to receive the $25.0 million conditional milestone payment or the additional $15.0 million conditional milestone payment.

The estimated probability and timing of a change in control event that triggers the exercisability of the Put/Call Option, the estimated cash flows and the discount rate used are Level 3 significant unobservable inputs used to determine the fair value of the derivative liability. Management concluded the probability of exercise of the Put/Call Option to be remote. The estimated market yield used to measure the fair value of the derivative was 12.0%15.7% and 11.5% as of MarchJune 31,30, 2026 and December 31, 2025, respectively. The initial fair value allocated to the derivative liability as of the close of the DRI Purchase and Sale Agreement was $19.3 million. Issuance costs of $1.8 million allocated to the derivative were recorded to expense as a component of other expense, net in the consolidated statements of operations and comprehensive loss. The derivative liability is subsequently remeasured at fair value each reporting period, with changes in fair value being recorded as a component of other expense, net in the consolidated statements of operations and comprehensive loss. As of MarchJune 31,30, 2026, the fair value of the derivative liability was $12.5$13.7 million resulting in recognition of a decrease in the fair value of $7.5$6.3 million during the threesix months ended MarchJune 31,30, 2026.