← Back to VRDN filing summaryOriginal filing text · Part I
Item 2 — Management's Discussion and Analysis
Viridian Therapeutics, Inc.\de · 10-Q · Q2 FY2026 · Period ended Jun 30, 2026
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The following discussion and analysis should be read together with our unaudited condensed consolidated financial statements and the related notes thereto included in Part I, Item 1 of this Quarterly Report and our consolidated financial statements and related notes thereto for the year ended December 31, 2025 included in our 2025 Annual Report on Form 10-K. This discussion and other parts of this report contain forward-looking statements reflecting our current expectations that involve risks and uncertainties, such as our plans, objectives, expectations, intentions, and beliefs. See “Forward-Looking Statements” for a discussion of the uncertainties, risks, and assumptions associated with these statements. Actual results and the timing of events could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in the section entitled “Risk Factors” included elsewhere in this Quarterly Report.
Overview and Recent Developments
We are a biopharmaceutical company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune 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 portfolio targets validated pathways and disease-driving mechanisms in autoimmune and rare diseases. These include our FDA-approved medicine veligrotug and product candidate elegrobart, both directed at IGF‑1R for the treatment of TED, our FcRn inhibitors with potential applications across multiple autoimmune disorders, and our 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.
In June 2026, the FDA approved veligrotug for the treatment of TED under Priority Review. In preparation for the veligrotug launch, we built 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. Following approval, we launched veligrotug in the United States under the trade name Lumvoa with commercial launch efforts focused on reaching target prescribers, enabling reliable access for patients, supporting physician offices and infusion centers, and engaging effectively with payors.
Our strategy combines clear scientific, clinical, and commercial rationale with excellence in execution to rapidly discover, develop, and commercialize better medicines for patients. We rely on our scientific, clinical, and commercial expertise to identify opportunities to improve upon existing investigational or approved therapies and to apply these insights to designing, selecting, developing, and commercializing potential best-in-class product candidates. We bring 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 risk when developing novel therapeutics.
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”).
In June 2026, the FDA approved veligrotug under Priority Review. Veligrotug provides a compelling new treatment option for TED in the U.S., in addition to the previously approved Tepezza® (teprotumumab), which is marketed in the United States by Amgen, Inc (“Amgen”).
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The FDA approval of veligrotug was supported by our pivotal phase 3 clinical trials THRIVE and THRIVE-2, which evaluated veligrotug in active and chronic TED, respectively. Both the THRIVE and THRIVE-2 clinical trials met their respective primary and all secondary endpoints, consistently demonstrating statistically significant and clinically meaningful improvements at week 15 across all of the key signs and symptoms of TED. Across both clinical trials, patients received a 12-week course of veligrotug designed to reduce the burden of treatment. Veligrotug demonstrated a rapid onset of clinical benefit, with reductions in proptosis observed as early as three weeks. Veligrotug is the first approved product for TED to show a statistically significant effect in both diplopia response and complete resolution in active and chronic TED. Veligrotug was granted Breakthrough Therapy Designation and Priority Review by the FDA. In June 2026, the results from the THRIVE pivotal phase 3 clinical trial in active TED were published in Ophthalmology.
We have established commercial infrastructure to support the U.S. launch of veligrotug, including sales and marketing, market access, patient services, medical affairs, distribution, supply chain and commercial operations capabilities. Our launch priorities include driving awareness of veligrotug with key stakeholders, including core prescribers, payers, infusion centers, physician offices and patients, differentiating veligrotug through its clinical profile and treatment regimen, and supporting access through payer engagement and patient services. We also established ViridianCares™, a patient support program designed to support patients, physician offices, and infusion centers through the treatment journey for eligible patients.
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 can 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 enrolled 321 patients in this safety study, exceeding the target enrollment of 284 patients due to demand, and achieved primary study completion in April 2026. Additionally, we conducted an autoinjector study to enable launching elegrobart in an autoinjector device, if approved. We enrolled 87 patients in the autoinjector study, exceeding the target enrollment of 75 patients, and completed the study in May 2026.
Development of FcRn Inhibitors
We 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
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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 IND for VRDN-006 in December 2024, which cleared in January 2025. In September 2025, we announced that data from an ongoing phase 1 clinical trial in healthy volunteers showed that VRDN-006 led to IgG reductions that are consistent with the FcRn inhibitor class, and that VRDN-006 was sparing of albumin and LDL and was generally well-tolerated with no dose-limiting toxicities or serious adverse events. We expect to communicate development plans for VRDN-006 in 2026.
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 efgartigimod, and IgG levels returned to 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 and LDL, consistent with efgartigimod. We submitted an IND for VRDN-008 in December 2025 and received IND clearance from the FDA in January 2026. A phase 1 clinical trial assessing VRDN-008 in healthy volunteers is currently ongoing with data on track for the second half of 2026.
Development of TSHR Inhibitors
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 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, 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.
Global Economic Considerations
The global macroeconomic environment is uncertain, and could be negatively affected by, among other things, increased U.S. trade tariffs and trade disputes with other countries, instability in the global capital and credit markets, supply chain weaknesses, and instability in the geopolitical environment, including as a result of the Russian invasion of Ukraine, the rising tensions between China and Taiwan, the conflict in Israel and surrounding area and other political tensions. Such challenges have caused, and may continue to cause, recession fears, concerns regarding potential sanctions, high interest rates, foreign exchange volatility and inflationary pressures. At this time, we are unable to quantify the potential effects of this economic instability on our future operations.
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Financial Operations Overview
Revenue
Our revenue has historically consisted primarily of up-front payments for licenses, milestone payments, and payments for other research and development services earned under license and collaboration agreements as well as for amounts earned under certain grants we have been awarded.
In October 2020, we entered into a license agreement with Zenas BioPharma. Subsequently, we entered into several letter agreements to assist Zenas BioPharma with certain development activities, including manufacturing. Under 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. 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 throughout the royalty term. The royalty percentage may vary based on different tiers of annual net sales of the licensed products made. In May 2022, we entered into a manufacturing development and supply agreement 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 manufacturing development and supply agreement to Zai Lab in connection with the sublicense transaction. In July 2025, we entered into a side agreement with Zai Lab (the “Side Agreement”), with Zenas BioPharma as countersigner, pursuant to which we agreed to provide certain services directly to Zai Lab to support development and commercialization activities. In August 2025, we 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 July 2025, we entered into a Collaboration and License Agreement pursuant to which we granted to Kissei an exclusive license to develop and commercialize products containing veligrotug and elegrobart including for the treatment of TED, in Japan, and, under certain circumstances, a non-exclusive license to manufacture such licensed products worldwide for use in Japan. As consideration for the Kissei Agreement, the transaction price included an upfront cash payment of $70.0 million, which was recognized as revenue during the year ended December 31, 2025. Additionally, we are eligible to receive up to an additional $315.0 million of non-refundable milestone payments upon achieving specific milestone events during the contract term, as well as tiered royalty payments ranging from percentages in the twenties to the mid-thirties based on the annual net sales of any licensed products sold in Japan.
In the future, we expect to continue to generate revenue from a combination of license fees and other upfront payments, payments for research and development services, milestone payments, product sales, and royalties in connection with strategic 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.
Research and Development Expenses
Research and development expenses consist of costs incurred for the research and development of our therapeutic programs and product candidates, which include:
•employee-related expenses, including salaries, severance, retention, benefits, insurance, and share-based compensation expense;
•expenses incurred under agreements with CROs, investigative sites that conduct our clinical trials, and other clinical trial-related vendors, and consultants;
•the costs of acquiring, developing, and manufacturing and testing clinical and nonclinical materials, including costs incurred under agreements with CDMOs;
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•costs associated with nonclinical activities and regulatory operations;
•license fees and milestone payments related to the acquisition and retention of certain licensed technology and intellectual property rights; and
•facilities, depreciation, market research, and other expenses, which include allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment, and laboratory supplies.
We make non-refundable advance payments for goods and services that will be used in future research and development activities. These payments are recorded as expense in the period in which we receive or take ownership of the goods or when the services are performed.
We record upfront 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.
We expect that our research and development expenses could increase if 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 programs described above.
Selling, General and Administrative Expenses
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
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 Agreement, Convertible Notes, and Hercules Loan and Security Agreement.
Critical Accounting Policies and Estimates
Our management’s discussion and analysis of financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ materially from these estimates under different assumptions or conditions.
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There have been no significant changes in our critical accounting policies and estimates as compared to the critical accounting policies and estimates disclosed in the section titled “Management’s Discussion and Analysis of Financial Condition and Operations” included in our Annual Report on Form 10-K filed with the SEC on February 26, 2026.
Results of Operations
Comparison of the Three Months Ended June 30, 2026 and 2025
Three Months Ended June 30, Change
2026 2025
(in thousands)
License revenue $ 233 $ — $ 233
Collaboration revenue - related parties $ 51 $ 75 (24)
Research and development expenses $ (71,577) $ (86,626) 15,049
Selling, general and administrative expenses $ (54,975) $ (20,216) (34,759)
Other income (expense), net $ (851) $ 6,032 (6,883)
Net Loss $ (127,119) $ (100,735) $ (26,384)
Revenue
License revenue for the three months ended June 30, 2026 was attributable to the collaboration and license agreement with Kissei. Collaboration revenue for both the three months ended June 30, 2026 and 2025 was attributable to our collaboration agreement with Zenas BioPharma and the Side Agreement and MTA with Zai Lab.
Research and Development Expenses
Three Months Ended June 30, Change
2026 2025
(in thousands)
Direct research and development expenses
TED portfolio $ 27,865 $ 47,542 $ (19,677)
FcRn inhibitor portfolio 8,190 19,576 (11,386)
Other research programs and expenses 12,611 388 12,223
Unallocated expenses
Personnel-related (including share-based compensation) 22,151 16,358 5,793
Facility and other expenses 760 2,762 (2,002)
Total research and development expenses $ 71,577 $ 86,626 $ (15,049)
Direct costs related to the TED portfolio decreased by $19.7 million during the three months ended June 30, 2026 compared to the three months ended June 30, 2025, primarily driven by a decrease in clinical trial and manufacturing associated costs due to the timing and stage of our phase 3 clinical trials for veligrotug.
Direct costs related to the FcRn inhibitor portfolio decreased by $11.4 million during the three months ended June 30, 2026 compared to the three months ended June 30, 2025, primarily driven by a decrease in clinical trial and manufacturing associated costs.
Direct costs related to other nonclinical research and development increased by $12.2 million during the three months ended June 30, 2026 compared to the three months ended June 30, 2025, primarily attributable to an increase in nonclinical research and manufacturing associated costs to support the development of the TSHR program.
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Personnel-related costs increased by $5.8 million during the three months ended June 30, 2026 compared to the three months ended June 30, 2025, primarily attributable to increased headcount required to support our ongoing research and development efforts.
Selling, General and Administrative Expenses
Three Months Ended June 30, Change
2026 2025
(in thousands)
Personnel-related (including share-based compensation) $ 34,219 $ 11,226 $ 22,993
Legal, consulting and professional services 18,201 8,142 10,059
Facility and other expenses 2,555 848 1,707
Total selling, general and administrative expenses $ 54,975 $ 20,216 34,759
Selling, general and administrative expenses were $55.0 million during the three months ended June 30, 2026, compared to $20.2 million during the three months ended June 30, 2025. The $34.8 million increase in selling, general and administrative expenses is primarily attributable to the following:
•$23.0 million increase in personnel-related costs, primarily due to an increase in headcount to support preparatory commercial activities for veligrotug and our growing organization; and
•$10.1 million increase in legal services, market research and other professional and consulting fees primarily for preparatory commercial activities for veligrotug.
Other Income (Expense), net
Other income (expense), net was $(0.9) million during the three months ended June 30, 2026 compared to $6.0 million during the three months ended June 30, 2025 primarily comprised of the change in fair value in the derivative liability and interest expense related to our DRI Purchase and Sale Agreement, Convertible Notes, and Hercules Loan and Security Agreement, including the loss on extinguishment of debt, partially offset by interest income earned on marketable securities.
Comparison of the Six Months Ended June 30, 2026 and 2025
Six Months Ended June 30, 2026 Change
2026 2025
(in thousands)
License revenue $ 239 $ — $ 239
Collaboration revenue - related parties $ 186 $ 147 39
Research and development expenses $ (149,208) $ (163,461) 14,253
Selling, general and administrative expenses $ (93,654) $ (37,319) (56,335)
Other income, net $ 10,417 $ 12,986 (2,569)
Net Loss $ (232,020) $ (187,647) $ (44,373)
Revenue
License revenue for the six months ended June 30, 2026 was attributable to the collaboration and license agreement with Kissei. Collaboration revenue for both the six months ended June 30, 2026 and 2025 was attributable to our collaboration agreement with Zenas BioPharma and the Side Agreement and MTA with Zai Lab.
Research and Development Expenses
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Six Months Ended June 30, 2026 Change
2026 2025
(in thousands)
Direct research and development expenses
TED portfolio $ 67,876 $ 94,536 $ (26,660)
FcRn inhibitor portfolio 17,779 30,566 (12,787)
Other research programs and expenses 19,931 777 19,154
Unallocated expenses
Personnel-related (including share-based compensation) 42,087 32,824 9,263
Facility and other expenses 1,535 4,758 (3,223)
Total research and development expenses $ 149,208 $ 163,461 $ (14,253)
Direct costs related to the TED portfolio decreased by $26.7 million during the six months ended June 30, 2026 compared to the six months ended June 30, 2025, primarily driven by a decrease in clinical trial and manufacturing associated costs due to timing and stage of our veligrotug phase 3 clinical trials that was partially offset by an increase of similar costs associated with elegrobart phase 3 clinical trial advancements.
Direct costs related to the FcRn inhibitor portfolio decreased by $12.8 million during the six months ended June 30, 2026 compared to the six months ended June 30, 2025, primarily driven by a decrease in clinical trial and manufacturing associated costs for our FcRn inhibitor portfolio.
Direct costs related to other nonclinical research and development increased by $19.2 million during the six months ended June 30, 2026 compared to the six months ended June 30, 2025, primarily attributable to an increase in nonclinical research and manufacturing associated costs to support the development of the TSHR program.
Personnel-related costs increased by $9.3 million during the six months ended June 30, 2026 compared to the six months ended June 30, 2025, primarily attributable to increased headcount to support our ongoing research and development efforts.
Selling, General and Administrative Expenses
Six Months Ended June 30, 2026 Change
2026 2025
(in thousands)
Personnel-related (including share-based compensation) $ 56,658 $ 20,904 $ 35,754
Legal, consulting and professional services 33,812 14,670 19,142
Facility and other expenses 3,184 1,745 1,439
Total selling, general and administrative expenses $ 93,654 $ 37,319 56,335
Selling, general and administrative expenses were $93.7 million during the six months ended June 30, 2026, compared to $37.3 million during the six months ended June 30, 2025. The $56.3 million increase in selling, general and administrative expenses is primarily attributable to the following:
•$35.8 million increase in personnel-related costs, primarily due to an increase in headcount to support preparatory commercial activities for veligrotug and our growing organization; and
•$19.1 million increase in legal, consulting and professional service fees primarily for preparatory commercial activities for veligrotug and other business activities.
Other Income, net
Other income, net was $10.4 million during the six months ended June 30, 2026 compared to $13.0 million during the six months ended June 30, 2025 primarily comprised of interest income earned on marketable securities and the change in fair
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value in the derivative liability, partially offset by interest expense related to our DRI Purchase and Sale Agreement, Convertible Notes, and Hercules Loan and Security Agreement, including the loss on extinguishment of debt.
Liquidity and Capital Resources
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. Prior to the approval of veligrotug in June 2026 and through June 30, 2026, the Company had not generated any revenue from product sales. Since our inception and through June 30, 2026, we have generated an accumulated deficit of $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 veligrotug, and from sales of 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 may be available to us. Our ability to achieve milestones under the DRI Purchase and Sale 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 June 30, 2026, we had $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 will be sufficient to fund our planned operations to break even where our anticipated revenues fund our anticipated operating expenses.
Due to numerous factors described in more detail under the caption Part II, Item 1A, “Risk Factors” of this Quarterly Report on Form 10-Q, we may require significant additional capital earlier than we currently expect under our present business plans.
Convertible Notes
In May 2026, we completed a public offering of $250.0 million aggregate principal amount of our 1.75% Convertible Senior Notes due 2032 (the “Notes”), including the exercise in full of the underwriters’ option to purchase up to an additional $25.0 million aggregate principal amount of the Notes. The Notes were issued pursuant to, and are governed by, an indenture (the “Indenture”), dated as of May 11, 2026, between us and U.S. Bank Trust Company, National Association, as trustee.
The Notes are our general, unsecured, senior obligations. The Notes will accrue interest payable semiannually in arrears on May 15 and November 15 of each year, beginning on November 15, 2026, at a rate equal to 1.75% per year. In addition, special interest will accrue on the Notes upon the occurrence of certain events relating to our failure to file certain reports with the SEC as provided in the Indenture. The Notes will mature on May 15, 2032, unless earlier converted, redeemed or repurchased by us.
Noteholders may convert their Notes at their option only in the following circumstances: (1) during any calendar quarter (and only during such calendar quarter) commencing after the calendar quarter ending on September 30, 2026, if the last reported sale price per share of our common stock, $0.01 par value per share, exceeds 130% of the conversion price for each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter; (2) during the five consecutive business days immediately after any 10 consecutive trading day period (such 10 consecutive trading day period, the “Measurement Period”) in which the trading price per $1,000 principal amount of Notes for each trading day of the Measurement Period was less than 98% of the product of the last reported sale price per share of the common stock on such trading day and the conversion rate on such trading day; (3) upon the occurrence of certain corporate events or distributions on the common stock, as described in the Indenture; (4) if we call such Notes for redemption; and (5) at any time from, and including, February 15, 2032 until the close of business on the scheduled trading day immediately before the maturity date. We will settle conversions by paying or delivering, as applicable, cash, shares of common stock or a combination of cash and shares of common stock, at our election, based on the applicable conversion rate. The initial conversion rate is 40.5680 shares of common stock per $1,000 principal amount of Notes, which
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represents an initial conversion price of approximately $24.65 per share, and is subject to adjustment as described in the Indenture.
The Notes are not redeemable prior to May 20, 2030. On or after May 20, 2030, we may redeem the Notes for cash (subject to certain limitations set forth in the Indenture) if the last reported sale price per share of the Common Stock exceeds 130% of the conversion price on (i) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date we send the related redemption notice; and (ii) the trading day immediately before the date we send such notice. However, we may not redeem less than all of the outstanding Notes unless at least $75.0 million aggregate principal amount of Notes are outstanding and not called for redemption as of the time we send the related redemption notice.
Public Offering
In May 2026, we entered into an underwriting agreement with Jefferies LLC, Leerink Partners LLC and Goldman Sachs & Co. LLC, relating to the offer and sale of 8,455,883 shares of our common stock, which included 1,102,941 shares of common stock issued in connection with the exercise in full by the underwriters of their option to purchase additional shares at a public offering price of $17.00 per share. The aggregate gross proceeds to us were approximately $143.8 million, before deducting underwriting discounts and commissions and other offering expenses payable by us.
Loan and Security Agreement with Hercules Capital, Inc.
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 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.
In August 2023, we executed the first amendment to the Hercules Loan and Security Agreement (the “Hercules First Amendment”). The Hercules First Amendment was determined to substantially alter the Hercules Loan and Security Agreement and therefore was accounted for as a debt extinguishment. Under the Hercules First Amendment, the maturity date was extended to October 1, 2026 and the Lenders provided the Borrower access to an increased term loan with an aggregate principal amount of up to $150.0 million, in four tranches, consisting of (i) an initial tranche of $50.0 million, $25.0 million of which was available through December 15, 2023, and $25.0 million of which was available from July 1, 2024 through December 15, 2024; (ii) a second tranche of $20.0 million, subject to achievement of certain regulatory milestones, which was available through February 15, 2025; (iii) a third tranche of $20.0 million, subject to achievement of certain regulatory milestones, which was available through March 31, 2025; and (iv) a fourth tranche of $60.0 million subject to approval by the Lenders’ investment committee(s), which was available through June 15, 2025. Upon execution of the Hercules First Amendment, the Borrower drew an additional principal amount of $15.0 million, increasing the cumulative amount drawn to $20.0 million. The obligations of the Borrower under the Hercules First Amendment agreement were secured by substantially all of the assets of the Borrower, excluding the Borrower’s intellectual property.
In October 2025, we executed a second amendment (the “Hercules Second Amendment”) to the Hercules Loan and Security Agreement. Under the Hercules Second Amendment, the term loan facility was amended to extend the maturity date to October 1, 2030 and provide an aggregate principal amount of up to $300.0 million, consisting of (i) an initial tranche of $100.0 million (“Tranche 1”), comprised of $30.0 million drawn upon execution of the Hercules Second Amendment, increasing the cumulative amount drawn to $50.0 million, $25.0 million (“Tranche 1B”) available through September 15, 2026, and $25.0 million available from the earlier to occur of the expiration or full funding of Tranche 1B through December 15, 2026, (ii) a second tranche of $50.0 million (“Tranche 2”), subject to achievement of certain regulatory milestones, available from (A) the earlier to occur of the full draw of Tranche 1 and December 15, 2025 through (B) the earlier to occur of June 15, 2027 and the date that is 60 days following such achievement of such regulatory milestones (the “Tranche 2 Expiration Date”), (iii) a third tranche of $50.0 million (“Tranche 3”), subject to achievement of certain regulatory milestones, available from (A) the earlier to occur of the full draw of Tranche 2 and the Tranche 2 Expiration Date through (B) the earlier to occur of June 15, 2027 and the date that is 60 days following such achievement of such regulatory milestones (the “Tranche 3 Expiration Date”), (iv) a fourth tranche of $50.0 million, subject to achievement of a certain revenue milestone, available from (A) the earlier to occur of the full draw of Tranche 3 and the Tranche 3 Expiration Date through (B) March 15, 2028, and (v) a fifth tranche of
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$50.0 million, subject to approval by the Lenders’ investment committee(s), available through October 1, 2030. The milestones for Tranche 2, Tranche 3 and Tranche 4 have not yet been achieved. The obligations of the Borrower under the Hercules Second Amendment are secured by substantially all of the assets of the Borrower.
In May 2026, using proceeds received from the issuance of the Notes described above, we entered into a payoff letter for a voluntary prepayment with respect to the Hercules Loan and Security Agreement (the “Payoff Letter”). Pursuant to the Payoff Letter, we paid a total of $55.1 million (the “Payoff Amount”) to Hercules, representing the outstanding principal, accrued and unpaid interest, fees, costs and expenses due to Hercules under the Hercules Loan and Security Agreement and related loan documents (collectively, the “Hercules Facility”), in repayment of the outstanding obligations and thereby terminated the Hercules Facility. We recorded a loss on extinguishment of debt of $4.1 million under "Other Income (Expense), net" in the Consolidated Statement of Operations and Comprehensive Loss for the three and six months ended June 30, 2026 and 2025 related to the write-off of the remaining balance of unamortized debt discount. Upon receipt by Hercules of the Payoff Amount on May 27, 2026, all obligations, covenants, debts and liabilities under the Hercules Facility were satisfied and discharged in full, and the Hercules Facility was terminated.
Purchase and Sale Agreement with DRI
In October 2025, we entered into a Purchase and Sale Agreement of revenue participation rights with DRI Healthcare Acquisitions LP (“DRI”), (the “DRI Purchase and Sale Agreement”), pursuant to which DRI purchased rights to certain revenue streams in the U.S. from us in exchange for up to $300.0 million in consideration, including $55.0 million paid at signing and conditional payments of up to $245.0 million for which we will become eligible to receive upon achieving certain regulatory and sales-based milestones.
The DRI Purchase and Sale Agreement contains customary representations, warranties and indemnities of the Company and DRI and customary covenants on the part of the Company, as well as a limit on the amount of incurrence of certain types of indebtedness, which limit automatically terminates a certain period of time following receipt of marketing approval for veligrotug in the U.S. The DRI Purchase and Sale Agreement requires us to pay tiered royalties to DRI based on net sales of veligrotug, elegrobart and certain other related products (the “Net Sales Royalties”). The royalties consist of (i) 7.5% of annual U.S. net sales up to and including $600 million, which royalties could increase to low-double digits if marketing approval for elegrobart is not received prior to a specified date, (ii) 0.8% of annual U.S. net sales above $600 million and up to and including $900 million, (iii) 0.25% of annual U.S. net sales above $900 million and up to $2 billion, and (iv) no royalty owed for annual U.S. net sales in excess of $2 billion. The DRI Purchase and Sale Agreement may only be terminated upon repayment by us of a certain multiplier of the consideration paid to us by DRI (less payments by us to DRI to date) on or prior to a certain date or repayment by an acquirer of us of a certain multiplier of the consideration paid by DRI to us (less payments by us to DRI to date) following a change of control of the Company.
We determined that the DRI Purchase and Sale Agreement is considered a sale of future revenues and is treated as a financing liability according to Accounting Standards Codification (“ASC”) 470, Debt, based on the specific facts and circumstances including our significant continuing involvement in the generation of the cash flows due to DRI. The sale of future revenue liability is accounted for as debt and is recorded at cost. After initial recognition of the debt instrument, we will use the effective interest method to account for the amount recorded as debt on our balance sheet. The effective interest rate is the rate that equates the present value of the estimated future cash flows with the carrying amount of the liability related to the sale of future revenue. The estimate of future cash flows includes estimated future Net Sales Royalties to be paid to DRI and the receipt of conditional payments from DRI that were deemed probable of achievement at inception. The interest rate on this financing liability may vary during the term of the agreement depending on a number of factors, including our net sales forecast and the probability of achieving certain milestones. We will evaluate the interest rate used to amortize the liability related to the sale of future revenue quarterly based on our expectations of future net sales and current market conditions using the prospective method. A significant increase or decrease in actual or forecasted net sales or changes in expected achievement of certain milestones may materially impact the liability, interest expense, and the time period for repayment. The conditional payments represent loan commitments that are not treated as freestanding financial instruments and qualify for the derivative scope exception under ASC 815, Derivatives and Hedging, and therefore have not been bifurcated and accounted for separately.
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
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milestone payment was received in July 2026. We accrued $2.6 million and $4.4 million in interest expense during the three and six months ended June 30, 2026. As of June 30, 2026, no payments of Net Sales Royalties to DRI have been made or accrued. As of June 30, 2026, the net carrying amount of the liability related to the sale of future revenue was $113.6 million. The imputed effective annual interest rate for the liability related to the sale of future revenue was 27.4% as of June 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 are not eligible to receive the $25.0 million conditional milestone payment or the additional $15.0 million conditional milestone payment.
Derivative Liability
In the event of a change of control of the Company at, or prior to, January 1, 2035, the DRI Purchase and Sale Agreement provides us an option to repurchase, and DRI an option to require us to repurchase, the revenue participation right from DRI (the “Put/Call Option”). Upon exercise of the Put/Call Option by us or DRI, the DRI Purchase and Sale Agreement will terminate, and we will become obligated to pay the applicable multiplier of the consideration paid to us by DRI to date, less the payments of Net Sales Royalties paid to DRI by us to date.
The Put/Call Option is an embedded derivative pursuant to ASC 815, Derivatives and Hedging, that must be bifurcated and measured at fair value initially and at each subsequent reporting period. We estimated the fair value of the derivative liability using a “with-and-without” method, which involves determining the fair value of the entire financial liability instrument, inclusive of all terms, features, and conditions, and separately determining the fair value of the financial liability instrument excluding the derivative. The difference between the fair value of the entire financial liability instrument including the derivative and the fair value of the financial liability instrument excluding the derivative represents the fair value of the derivative liability.
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 15.7% and 11.5% as of June 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 June 30, 2026, the fair value of the derivative liability was $13.7 million resulting in recognition of a decrease in the fair value of $6.3 million during the six months ended June 30, 2026.
ATM Agreement
In March 2025, we entered into an Open Market Sale AgreementSM (the “March 2025 ATM Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which we may offer and sell shares of our common stock having an aggregate offering price of up to $300.0 million from time to time at prices and on terms to be determined by market conditions at the time of offering, with Jefferies acting as its sales agent. Jefferies will receive a commission of up to 3.0% of the gross proceeds of any shares of common stock sold under the March 2025 ATM Agreement. No shares were sold under the March 2025 ATM Agreement during the three and six months ended June 30, 2026 and 2025.
Summarized cash flows for the six months ended June 30, 2026 and 2025 are as follows:
Six Months Ended June 30, Change
2026 2025
(in thousands)
Net cash provided by (used in):
Operating activities $ (224,978) $ (168,026) $ (56,952)
Investing activities (153,896) 175,780 (329,676)
Financing activities 331,478 9,976 321,502
Net increase (decrease) in cash and cash equivalents $ (47,396) $ 17,730 $ (65,126)
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Operating Activities
Net cash used in operating activities was $225.0 million for the six months ended June 30, 2026, and primarily consisted of a net loss of $232.0 million, adjusted for non-cash items of $30.3 million (primarily share-based compensation of $30.4 million), and changes in working capital of $23.2 million. The change in working capital was primarily related to a decrease of $17.6 million in accrued liabilities due to the timing of payments related to employee compensation and payments to vendors for ongoing clinical trial and manufacturing activities.
Net cash used in operating activities was $168.0 million for the six months ended June 30, 2025, and primarily consisted of a net loss of $187.6 million, adjusted for non-cash items of $17.6 million (primarily share-based compensation of $21.1 million, partially offset by accretion and amortization of premiums and discounts on available-for-sale securities of $3.9 million) and changes in working capital of $2.0 million. The change in working capital was primarily related to a decrease of $5.5 million in prepaid expenses and other current assets, partially offset by a net decrease of $3.3 million in accounts payable and accrued and other liabilities due to the timing of payments related to employee compensation and payments to vendors for ongoing clinical trial and manufacturing activities.
Investing Activities
Net cash used by investing activities was $153.9 million during the six months ended June 30, 2026, and consisted primarily of net purchases of marketable securities.
Net cash provided by investing activities was $175.8 million during the six months ended June 30, 2025, and consisted primarily of $175.9 million in net maturities of marketable securities.
Financing Activities
Net cash provided by financing activities was $331.5 million during the six months ended June 30, 2026, and consisted of net proceeds from the sale of convertible notes of $242.5 million and net proceeds from the issuance of common stock of $135.5 million, offset by cash outflows related to the debt extinguishment of $54.7 million.
Net cash provided by financing activities was $10.0 million during the six months ended June 30, 2025, and consisted primarily of net proceeds of $4.7 million from the September 2022 ATM Agreement, as well as $3.1 million in proceeds from the exercise of stock options, $1.6 million in proceeds from the exercise of warrants, and $0.6 million in proceeds from the issuance of common stock under our employee stock purchase plan.