Viridian Therapeutics, Inc.\DE

Previous wording

We are a biopharmaceutical company focused on discovering, developing, and commercializing potential best-in-class medicines for serious 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.

Current wording

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.

Previous wording

Our pipeline targets validated pathways and disease-driving mechanisms in autoimmune and rare diseases. These include product candidates directed at IGF‑1R for the treatment of TED, inhibitors of the FcRn with potential application across multiple autoimmune disorders, and a TSHR inhibitor program with 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.

Current wording

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.

Previous wording

As we prepare for the anticipated launch of our first commercial product, if approved, we are building the infrastructure we believe is required to support a successful transition to a commercial organization. This includes establishing sales and marketing, market access, patient services, and commercial operations functions, and expanding our medical, clinical, regulatory, quality, and supply chain and distribution capabilities. Our commercial readiness efforts focus on enabling reliable access for patients, supporting physicians, and engaging effectively with payors.

Current wording

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.

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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”).

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 cab 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 are evaluating elegrobart administered subcutaneously every four weeks (“Q4W”) or every eight weeks (“Q8W”) and assessing outcomes versus placebo.

Previous wording

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.

Current wording

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.

Previous wording

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 completed enrollment of this safety study in October 2025, enrolling 321 patients, exceeding the target enrollment of 284 patients due to demand. Additionally, we are conducting an auto-injector study to enable launching elegrobart in an auto-injector device, if approved. We completed enrollment in the autoinjector study in December 2025, enrolling 87 patients, exceeding the target enrollment of 75 patients.

Current wording

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.

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 (“TRAb”) can drive a heightened activation of TSHR, resulting in excessive thyroid hormone production and hyperthyroidism. Graves’ disease is one of the most prevalent autoimmune conditions, affecting more than 2 million people in the United States, and is the leading cause of hyperthyroidism. Current treatments—including antithyroid drugs, radioactive iodine (“RAI”), 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 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.

Previous wording

We expect that our research and development expenses will increase as 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.

Current wording

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.

Previous wording

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 program described above.

Current wording

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.

Previous wording

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 to prepare for commercial activities, as well as insurance, board of director compensation, consulting, and other administrative expenses.

Current wording

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.

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 and Hercules Loan and Security Agreement.

Current 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.

Previous wording

Direct costs related to the TED portfolio decreased by $7.0 million during the three months ended March 31, 2026 compared to the three months ended March 31, 2025, primarily driven by the progression of our portfolio, including the following:

Current 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.

Previous wording

Direct costs related to the FcRn inhibitor portfolio decreased by $1.4 million during the three months ended March 31, 2026 compared to the three months ended March 31, 2025, primarily attributable to a $1.7 million decrease in certain milestone payments incurred in the first quarter of 2025.

Current 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.

Previous wording

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

Current 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.

Previous wording

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

Current 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.

Previous wording

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

Current 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:

Previous wording

•$12.8 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

•$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

Previous wording

•$9.1 million increase in legal services, market research and other professional and consulting fees primarily for preparatory commercial activities for veligrotug.

Current wording

•$10.1 million increase in legal services, market research and other professional and consulting fees primarily for preparatory commercial activities for veligrotug.

Previous wording

Other income, net was $11.3 million during the three months ended March 31, 2026 compared to $7.0 million during the three months ended March 31, 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 and Hercules Loan and Security Agreement.

Current 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.

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. We have no products approved for commercial sale and have not generated any revenue from product sales. Since our inception and through March 31, 2026, we have generated an accumulated deficit of $1,443.4 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. 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.

Previous wording

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 elegrobart in the U.S., if regulatory approval is granted, depends on us being able to establish sales and marketing capabilities and gain acceptance in the marketplace, which we may be unable to do in a timely manner or at all. In addition, we cannot predict with any certainty whether and to what extent the timing or availability of additional funds under the DRI Purchase and Sale Agreement or the Hercules Loan and Security Agreement may be available to us. Our ability to achieve milestones under the DRI Purchase and Sale Agreement or draw down on the remaining tranches under the Hercules Loan and Security Agreement is subject to our achievement of certain regulatory and commercial milestones on or before certain dates or, for certain milestones, on mutual agreement of the applicable party.

Current wording

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.

Previous wording

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

Current 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.

Previous wording

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, 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.

Current wording

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.

Previous wording

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 $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.

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, 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

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. We accrued $1.8 million in interest expense during the three months ended March 31, 2026. As of March 31, 2026, no payments of Net Sales Royalties to DRI have been made or accrued. As of March 31, 2026, the net carrying amount of the liability related to the sale of future revenue was $36.1 million. The imputed effective annual interest rate for the liability related to the sale of future revenue was 27.7% as of March 31, 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 is 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 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.

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 12.0% and 11.5% as of March 31, 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 March 31, 2026, the fair value of the derivative liability was $12.5 million resulting in recognition of a decrease in the fair value of $7.5 million during the three months ended March 31, 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 15.7% 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.

Previous wording

In March 2025, we entered into an Open Market Sale Agreement SM (the “March 2025 ATM Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which we may offer and sell shares of its 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 months ended March 31, 2026 and 2025.

Current wording

In March 2025, we entered into an Open Market Sale Agreement SM (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.

Previous wording

Summarized cash flows for the three months ended March 31, 2026 and 2025 are as follows:

Current wording

Summarized cash flows for the six months ended June 30, 2026 and 2025 are as follows:

Previous wording

Net cash used in operating activities was $119.7 million for the three months ended March 31, 2026, and primarily consisted of a net loss of $104.9 million, adjusted for non-cash items of $6.6 million (primarily share-based compensation of $13.4 million, partially offset by the change in fair value of derivative liability of $7.5 million), and changes in working capital of $21.4 million. The change in working capital was primarily related to a decrease of $23.5 million in accrued liabilities due to the timing of payments to vendors for ongoing clinical trial and manufacturing activities.

Current wording

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.

Previous wording

Net cash used in operating activities was $92.7 million for the three months ended March 31, 2025, and primarily consisted of a net loss of $86.9 million, adjusted for non-cash items of $8.1 million (primarily share-based compensation of $10.2 million, partially offset by accretion and amortization of premiums and discounts on available-for-sale securities of $2.3 million) and changes in working capital of $13.9 million. The change in working capital was primarily related to a net decrease of $14.1 million in accounts payable and accrued and other liabilities, partially offset by a decrease of $0.3 million in prepaid expenses and other current assets due to the timing of payments to vendors for ongoing clinical trial and manufacturing activities.

Current wording

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.

Previous wording

Net cash used in investing activities was $100.1 million during the three months ended March 31, 2025, and consisted primarily of $100.1 million in net purchases of marketable securities.

Current wording

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.

Previous wording

Net cash provided by investing activities was $77.3 million during the three months ended March 31, 2026, and consisted primarily of net maturities of marketable securities.

Current wording

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.

Previous wording

Net cash provided by financing activities was $9.2 million during the three months ended March 31, 2025, and consisted primarily of net proceeds of $4.7 million from the September 2022 ATM Agreement, as well as $2.3 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.

Current wording

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.