Viridian Therapeutics, Inc.\DE

Previous wording

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.

Current wording

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 “Cautionary Note Regarding 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.

Previous wording

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”).

Current wording

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

Previous wording

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.

Current wording

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. In June 2026, the results from the THRIVE pivotal phase 3 clinical trial in active TED were published in Ophthalmology. In September 2026, we initiated an open-label clinical trial of veligrotug in participants with TED who previously responded to teprotumumab.

Previous wording

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.

Current wording

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 evaluated elegrobart administered subcutaneously every four weeks (“Q4W”) or every eight weeks (“Q8W”) and assessed outcomes versus placebo.

Previous wording

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 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.

Current wording

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 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. We expect to communicate development plans for our portfolio of FcRn inhibitors in the fourth quarter of 2026.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

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 fourth quarter of 2026.

Previous wording

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.

Current wording

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 expect to initiate a phase 1 clinical trial of our anti-TSHR antibody, VRDN-292, starting in patients with Graves’ disease 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.

Previous wording

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.

Current wording

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 United States’ conflict with Iran, ongoing conflicts 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.

Previous wording

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.

Current wording

Our license and collaboration 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.

Previous wording

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.

Current wording

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.

Previous wording

•the costs of acquiring, developing, and manufacturing and testing clinical and nonclinical materials, including costs incurred under agreements with CDMOs;

Current wording

•the costs of acquiring, developing, and manufacturing and testing pre-commercial and nonclinical materials, including costs incurred under agreements with CDMOs;

Previous wording

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.

Current wording

Other income, 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 the DRI Purchase and Sale Agreement, the Notes, and the Hercules Loan and Security Agreement.

Previous wording

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.

Current wording

Except as described below, 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 Results of Operations” included in our Annual Report on Form 10-K filed with the SEC on February 26, 2026. Following the FDA’s approval of veligrotug in June 2026, we adopted accounting policies for product revenue, net, including estimates of variable consideration for rebates, chargebacks, returns and other incentives, as well as for inventory and for the capitalization and amortization of the milestone-related intangible asset. See Note 2, Summary of Significant Accounting Policies, to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.

Previous wording

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.

Current wording

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

Previous wording

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.

Current wording

•Direct costs related to the TED portfolio decreased by $31.3 million during the three months ended September 30, 2026 compared to the three months ended September 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 and elegrobart.

Previous wording

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.

Current wording

•Direct costs related to the FcRn inhibitor portfolio increased by $4.2 million during the three months ended September 30, 2026 compared to the three months ended September 30, 2025, primarily driven by an increase in clinical trial and manufacturing associated costs.

Previous wording

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.

Current wording

•Direct costs related to other research programs and expenses increased by $5.9 million during the three months ended September 30, 2026 compared to the three months ended September 30, 2025, primarily attributable to an increase in nonclinical research and manufacturing associated costs to support the development of the TSHR program.

Previous wording

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.

Current wording

•Personnel-related costs increased by $6.4 million during the three months ended September 30, 2026 compared to the three months ended September 30, 2025, primarily attributable to increased headcount required to support our ongoing research and development efforts.

Previous wording

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:

Current wording

Selling, general and administrative expenses were $57.6 million during the three months ended September 30, 2026, compared to $24.3 million during the three months ended September 30, 2025. The $33.3 million increase in selling, general and administrative expenses is primarily attributable to the following:

Previous wording

•$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

Current wording

•$23.2 million increase in personnel-related costs, primarily due to an increase in headcount to support commercial activities for veligrotug and our growing organization; and

Previous wording

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.

Current wording

Other income, net was $2.3 million during the three months ended September 30, 2026 compared to $5.4 million during the three months ended September 30, 2025 primarily comprised of interest income earned on cash equivalents and marketable securities and the change in fair value of the derivative liability, partially offset by interest expense related to the DRI Purchase and Sale Agreement and the Notes.

Previous wording

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.

Current wording

Collaboration revenue for both the nine months ended September 30, 2026 and 2025 was attributable to our collaboration agreement with Zenas BioPharma and the Side Agreement and MTA with Zai Lab.

Previous wording

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.

Current wording

•Direct costs related to the TED portfolio decreased by $59.9 million during the nine months ended September 30, 2026 compared to the nine months ended September 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.

Previous wording

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.

Current wording

•Direct costs related to the FcRn inhibitor portfolio decreased by $8.4 million during the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025, primarily driven by a decrease in clinical trial and manufacturing associated costs for our FcRn inhibitor portfolio.

Previous wording

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.

Current wording

•Direct costs related to other research programs and expenses increased by $24.7 million during the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025, primarily attributable to an increase in nonclinical research and manufacturing associated costs to support the development of the TSHR program.

Previous wording

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.

Current wording

•Personnel-related costs increased by $15.7 million during the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025, primarily attributable to increased headcount to support our ongoing research and development efforts.

Previous wording

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:

Current wording

Selling, general and administrative expenses were $151.3 million during the nine months ended September 30, 2026, compared to $61.6 million during the nine months ended September 30, 2025. The $89.6 million increase in selling, general and administrative expenses is primarily attributable to the following:

Previous wording

•$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

Current wording

•$58.9 million increase in personnel-related costs, primarily due to an increase in headcount to support commercial activities for veligrotug and our growing organization; and

Previous wording

•$19.1 million increase in legal, consulting and professional service fees primarily for preparatory commercial activities for veligrotug and other business activities.

Current wording

•$26.3 million increase in professional and consulting fees primarily related to commercial activities supporting veligrotug and other business activities.

Previous wording

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 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.

Current wording

Other income, net was $12.7 million during the nine months ended September 30, 2026 compared to $18.4 million during the nine months ended September 30, 2025 primarily comprised of interest income earned on cash equivalents and marketable securities and the change in fair value of the derivative liability, partially offset by interest expense related to the DRI Purchase and Sale Agreement, the Notes, and the Hercules Loan and Security Agreement, including the loss on the extinguishment of debt.

Previous wording

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.

Current wording

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. After receiving approval from the FDA in June 2026, we have also funded our operations from sales of veligrotug. Since our inception and through September 30, 2026, we have generated an accumulated deficit of $1,671.7 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.

Previous wording

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.

Current wording

As of September 30, 2026, we had $955.2 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 the unaudited condensed consolidated financial statements included in this Quarterly Report. 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.

Previous wording

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.

Current wording

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 our 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.

Previous wording

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.

Current wording

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

Previous wording

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

Current wording

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, available upon achievement of certain milestones. The obligations of the Borrower under the Hercules Second Amendment were secured by substantially all of the assets of the Borrower. The Borrower did not draw any amounts under the Hercules Facility other than the $50.0 million described above prior to its termination in May 2026, as described below.

Previous wording

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.

Current wording

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 "Interest expense" in the Condensed Consolidated Statements of Operations and Comprehensive Loss for the nine months ended September 30, 2026 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.

Previous wording

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.

Current wording

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, which we will become eligible to receive upon achieving certain regulatory and sales-based milestones.

Previous wording

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 $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.

Current wording

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 received a $75.0 million milestone payment. We accrued $8.0 million and $12.4 million in interest expense during the three and nine months ended September 30, 2026, including Net Sales Royalties of $1.9 million for both the three and nine months ended September 30, 2026. As of September 30, 2026, the net carrying amount of the liability related to the sale of future revenue was $121.6 million. The imputed effective annual interest rate for the liability related to the sale of future revenue was 27.1% as of September 30, 2026. During the first quarter of 2026, we did not achieve certain milestones with respect to our 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.

Previous wording

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.

Current wording

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 15.8% and 11.5% as of September 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 September 30, 2026, the fair value of the derivative liability was $11.6 million resulting in recognition of a decrease in the fair value of $8.4 million during the nine months ended September 30, 2026.