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Viridian Therapeutics, Inc.\DE

For the period ended Jun 30, 2025. Filed Aug 6, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2025 · Filed Aug 6, 2025

VRDN$28.49-0.2%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-03-31; filed 2025-05-06.

0001590750-25-000008

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-06-30; filed 2025-08-06.

0001590750-25-000012

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 98 previous paragraphs and 112 current paragraphs.

59 unchanged; 32 reworded; 11 added; 6 removed; 1 previous and 10 current paragraphs rearranged.

Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (11)

Current report

•$2.3 million increase in clinical study costs to advance VRDN-006.

Current report

Facility and other operating costs increased $1.2 million during the three months ended June 30, 2025 compared to the three months ended June 30, 2024, primarily attributable to a $1.1 million increase in professional services fees for consultants and contractors to support the planned BLA submission for veligrotug and to advance clinical trials for VRDN-003.

Current report

•$1.1 million increase in personnel related costs, due primarily to increased headcount to support the growing organization.

Current report

Direct costs related to the TED portfolio increased by $41.2 million during the six months ended June 30, 2025 compared to the six months ended June 30, 2024, primarily attributable to:

Current report

Direct costs related to the FcRn inhibitor portfolio increased by $19.7 million during the six months ended June 30, 2025 compared to the six months ended June 30, 2024, primarily attributable to:

Current report

Personnel-related costs increased by $4.5 million during the six months ended June 30, 2025 compared to the six months ended June 30, 2024, primarily attributable to:

Current report

General and administrative expenses were $37.3 million during the six months ended June 30, 2025, compared to $31.1 million during the six months ended June 30, 2024. The $6.2 million increase in general and administrative expenses is primarily attributable to the following:

Current report

•$4.4 million increase in personnel related costs, due primarily to increased headcount to support the growing organization;

Current report

•$3.4 million decrease in share-based compensation due to the acceleration of stock option vesting for former executive officers during the six months ended June 30, 2024.
Removed paragraphs (6)
Reworded paragraphs (32)

Previous wording

We are conducting a global pivotal program for veligrotug, including evaluating its efficacy and safety in two global well-controlled phase 3 clinical trials, THRIVE and THRIVE-2, for the treatment of active and chronic TED, respectively. THRIVE and THRIVE-2 are each designed to compare a five-dose IV treatment arm of veligrotug at 10 mg/kg, dosed three weeks apart, to placebo. This five-dose veligrotug regimen features fewer infusions and a shorter time per infusion compared to teprotumumab, the currently marketed IGF-1R inhibitor. On September 10, 2024, we announced topline data from the THRIVE study, which enrolled 113 patients, randomized to veligrotug (n=75) and placebo (n=38). THRIVE achieved all primary and secondary endpoints with a high level of statistical significance (p < 0.0001) and was generally well-tolerated, with no treatment-related serious adverse events (“SAEs”). Veligrotug additionally showed a rapid onset of treatment effect, with the majority (53%) of veligrotug-treated patients achieving a proptosis response as early as three weeks. On December 16, 2024, we announced topline data from the THRIVE-2 study, which enrolled 188 patients, randomized to veligrotug (n=125) and placebo (n=63). THRIVE-2 achieved all primary and secondary endpoints with statistical significance and was generally well-tolerated. Veligrotug continued to demonstrate a rapid onset of treatment effect, with a statistically significant proptosis response as early as three weeks and a statistically significant reduction and resolution of diplopia as early as six weeks. THRIVE-2 is the first global phase 3 study in patients with chronic TED to demonstrate a statistically significant and clinically meaningful diplopia responder rate and rate of diplopia complete resolution. To meet the 300 patient standard safety database requirements for the veligrotug BLA, we are conducting our STRIVE clinical trial (safety database inclusive of patients from the THRIVE and THRIVE-2 trials). STRIVE is a global study of veligrotug in TED patients that utilizes broad inclusion criteria (e.g., any severity or duration of disease) and is randomized 3:1 (10 mg/kg IV with an active control of 3 mg/kg IV). In January 2025, we completed enrollment in STRIVE with a total of 231 patients, exceeding the enrollment target of 212 due to patient demand. We have also completed enrollment of the open label extension study for non-responding patients in THRIVE and THRIVE-2. We anticipate submitting a BLA for veligrotug in the second half of 2025 and an MAA to the EMA in the first half of 2026.

Current wording

We are conducting a global pivotal program for veligrotug, including evaluating its efficacy and safety in two global well-controlled phase 3 clinical trials, THRIVE and THRIVE-2, for the treatment of active and chronic TED, respectively. THRIVE and THRIVE-2 are each designed to compare a five-dose IV treatment arm of veligrotug at 10 mg/kg, dosed three weeks apart, to placebo. This five-dose veligrotug regimen features fewer infusions and a shorter time per infusion compared to teprotumumab, the currently marketed IGF-1R inhibitor. On September 10, 2024, we announced topline data from the THRIVE study, which enrolled 113 patients, randomized to veligrotug (n=75) and placebo (n=38). THRIVE achieved all primary and secondary endpoints with a high level of statistical significance (p < 0.0001) and was generally well-tolerated, with no treatment-related serious adverse events (“SAEs”). Veligrotug additionally showed a rapid onset of treatment effect, with the majority (53%) of veligrotug-treated patients achieving a proptosis response as early as three weeks. On December 16, 2024, we announced topline data from the THRIVE-2 study, which enrolled 188 patients, randomized to veligrotug (n=125) and placebo (n=63). THRIVE-2 achieved all primary and secondary endpoints with statistical significance and was generally well-tolerated. Veligrotug continued to demonstrate a rapid onset of treatment effect, with a statistically significant proptosis response as early as three weeks and a statistically significant reduction and resolution of diplopia as early as six weeks. THRIVE-2 is the first global phase 3 study in patients with chronic TED to demonstrate a statistically significant and clinically meaningful diplopia responder rate and rate of diplopia complete resolution. Veligrotug demonstrated positive durability at 52 weeks in THRIVE, showing that 70% of patients who were proptosis responders at week 15 maintained their response at week 52. To meet the 300 patient standard safety database requirements for the veligrotug BLA, we are conducting our STRIVE clinical trial (safety database inclusive of patients from the THRIVE and THRIVE-2 trials). STRIVE is a global study of veligrotug in TED patients that utilizes broad inclusion criteria (e.g., any severity or duration of disease) and is randomized 3:1 (10 mg/kg IV with an active control of 3 mg/kg IV). In January 2025, we completed enrollment in STRIVE with a total of 231 patients, exceeding the enrollment target of 212 due to patient demand. We have also completed enrollment of the open label extension study for non-responding patients in THRIVE and THRIVE-2. In May 2025, the U.S. FDA granted Breakthrough Therapy designation to veligrotug. We anticipate submitting a BLA for veligrotug in the second half of 2025 and an MAA to the EMA in the first half of 2026.

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 while not showing decreases in albumin or increases in LDL levels. NHP studies are ongoing to generate additional data for VRDN-008. Once completed, we plan to use the totality of VRDN-008’s NHP data to build a robust pharmacokinetic and pharmacodynamic model to predict potential human dosing regimens for VRDN-008. We anticipate submitting an IND for VRDN-008 by the end of 2025.

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 low-density lipoprotein (LDL), consistent with efgartigimod. We anticipate submitting an IND for VRDN-008 by the end of 2025.

Previous wording

There were no changes to our critical accounting policies as disclosed in our 2024 Annual Report on Form 10-K during the three months ended March 31, 2025. Our significant accounting policies are disclosed in Note 2. Summary of Significant Accounting Policies to our condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report.

Current wording

There were no changes to our critical accounting policies as disclosed in our 2024 Annual Report on Form 10-K during the six months ended June 30, 2025. Our significant accounting policies are disclosed in Note 2. Summary of Significant Accounting Policies to our condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report.

Previous wording

Direct costs related to the TED portfolio increased by $25.8 million during the three months ended March 31, 2025 compared to the three months ended March 31, 2024, primarily attributable to:

Current wording

Direct costs related to the TED portfolio increased by $15.4 million during the three months ended June 30, 2025 compared to the three months ended June 30, 2024, primarily attributable to:

Previous wording

•$22.9 million increase in clinical trial costs and a $4.0 million increase in chemistry, manufacturing and controls costs to support the ongoing global phase 3 clinical trials for veligrotug and VRDN-003; partially offset by,

Current wording

•$14.0 million increase in clinical trial costs and a $2.3 million increase in chemistry, manufacturing and controls costs to support the ongoing global phase 3 clinical trials for veligrotug and VRDN-003; partially offset by,

Previous wording

Direct costs related to the FcRn inhibitor portfolio increased by $8.4 million during the three months ended March 31, 2025 compared to the three months ended March 31, 2024, primarily attributable to:

Current wording

Direct costs related to the FcRn inhibitor portfolio increased by $11.3 million during the three months ended June 30, 2025 compared to the three months ended June 30, 2024, primarily attributable to:

Previous wording

Personnel-related costs increased by $2.0 million during the three months ended March 31, 2025 compared to the three months ended March 31, 2024, primarily attributable to:

Current wording

Personnel-related costs increased by $2.5 million during the three months ended June 30, 2025 compared to the three months ended June 30, 2024, primarily attributable to:

Previous wording

•$3.1 million increase in personnel related costs, due primarily to increased headcount to support our ongoing research and development efforts, including share-based compensation and other employee compensation and recruiting costs; partially offset by,

Current wording

•$4.1 million increase in personnel related costs, due primarily to increased headcount to support our ongoing research and development efforts, including share-based compensation and other employee compensation and recruiting costs; partially offset by,

Previous wording

•$1.1 million decrease in severance costs primarily related to separation agreements with former executive officers, including a $0.5 million decrease in share-based compensation related to the acceleration of stock option vesting during the three months ending March 31, 2025 compared to the three months ending March 31, 2024.

Current wording

•$1.7 million decrease in severance costs primarily related to separation agreements with former executive officers, including a $1.1 million decrease in share-based compensation due to the acceleration of stock option vesting during the three months ending June 30, 2024.

Previous wording

We expect our research and development expenses to continue to increase as we continue to advance our clinical and nonclinical programs.

Current wording

We expect our research and development expenses to remain consistent as we continue to advance our clinical and nonclinical programs.

Previous wording

General and administrative expenses were $17.1 million during the three months ended March 31, 2025, compared to $15.0 million during the three months ended March 31, 2024. The $2.1 million increase in general and administrative expenses is primarily attributable to the following:

Current wording

General and administrative expenses were $20.2 million during the three months ended June 30, 2025, compared to $16.1 million during the three months ended June 30, 2024. The $4.2 million increase in general and administrative expenses is primarily attributable to the following:

Previous wording

•$1.3 million increase in legal, accounting and other professional service fees to support the growing organization.

Current wording

•$1.3 million increase in legal, accounting and other professional service fees to support the growing organization; and

Previous wording

Other income, net was $7.0 million during the three months ended March 31, 2025 compared to $7.4 million during the three months ended March 31, 2024. Other income, net for the three months ended March 31, 2025 is comprised of $7.5 million of interest income earned on short-term investments, partially offset by $0.6 million in interest expense related to our Hercules Loan and Security Agreement. Other income, net for the three months ended March 31, 2024 is comprised of $7.9 million of interest income earned on short-term investments as well as $0.1 million of sub-lease income, partially offset by $0.6 million in interest expense related to our Hercules Loan and Security Agreement.

Current wording

Other income, net was $6.0 million during the three months ended June 30, 2025 compared to $7.2 million during the three months ended June 30, 2024. Other income, net for the three months ended June 30, 2025 is comprised of $6.5 million of interest income earned on short-term investments, partially offset by $0.6 million in interest expense related to our Hercules Loan and Security Agreement. Other income, net for the three months ended June 30, 2024 is comprised of $7.7 million of interest income earned on short-term investments as well as $0.1 million of sub-lease income, partially offset by $0.6 million in interest expense related to our Hercules Loan and Security Agreement.

Previous wording

•$1.2 million increase in chemistry, manufacturing, and controls costs to support IND-enabling activities for assets across out FcRn inhibitor portfolio.

Current wording

•$10.4 million increase in chemistry, manufacturing, and controls costs to support IND-enabling activities for assets across the FcRn inhibitor portfolio;

Previous wording

•$2.5 million increase in nonclinical research and early clinical study activity to advance the FcRn inhibitor portfolio;

Current wording

•$4.5 million increase in nonclinical research and clinical study activity to advance the FcRn inhibitor portfolio;

Previous wording

•$4.5 million increase in milestone, license and option fees, primarily due to a $3.5 million milestone payment to Paragon for achievement of certain research and development objectives for VRDN-008 and a $1.0 million milestone payment to Paragon for achievement of a clinical milestone for VRDN-006; and

Current wording

•$4.5 million increase in milestone, license and option fees, primarily due to a $3.5 million milestone payment to Paragon for achievement of certain research and development objectives for VRDN-008 and a $1.0 million milestone payment to Paragon for achievement of a clinical milestone for VRDN-006.

Previous wording

Facility and other operating costs decreased $0.2 million during the three months ended March 31, 2025 compared to the three months ended March 31, 2024, primarily attributable to a $0.4 million decrease in professional services fees for consultants and contractors, partially offset by a $0.2 million increase in facility and information technology costs to support the growing organization.

Current wording

Facility and other operating costs increased $1.0 million during the six months ended June 30, 2025 compared to the six months ended June 30, 2024, primarily attributable to a $0.7 million increase in professional services fees for consultants and contractors to support the planned BLA submission for veligrotug and to advance clinical trials for VRDN-003 and a $0.3 million increase in facility and information technology costs to support the growing organization.

Previous wording

•$1.0 million increase in market research and related costs to prepare for the potential commercialization of veligrotug; and

Current wording

•$3.3 million increase in market research and related costs to prepare for the potential commercialization of veligrotug; and

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. As of March 31, 2025, we had $636.6 million in cash, cash equivalents, and short-term investments. We expect that our current cash, cash equivalents and short-term investments will be sufficient to fund our planned operations, including our clinical development plan described above, into the second half of 2027. In addition, as of March 31, 2025, the Company has access to additional undrawn funds under the Hercules Loan and Security Agreement, as described below.

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. As of June 30, 2025, we had $563.4 million in cash, cash equivalents, and short-term investments. We expect that our current cash, cash equivalents and short-term investments will be sufficient to fund our planned operations, including our clinical development plan described above, into the second half of 2027.

Previous wording

We have no products approved for commercial sale and have not generated any revenue from product sales. Since our inception and through March 31, 2025, we have generated an accumulated deficit of $1,082.8 million. Substantially all of our operating losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

Current wording

We have no products approved for commercial sale and have not generated any revenue from product sales. Since our inception and through June 30, 2025, we have generated an accumulated deficit of $1,183.5 million. Substantially all of our operating losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

Previous wording

On April 1, 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 (collectively the “Term Loan”), including an initial tranche of $25.0 million, which was available to us through June 15, 2023. Upon signing, we drew an initial principle 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

On April 1, 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 (collectively the “Term Loan”), including an initial tranche of $25.0 million, which was available to us through June 15, 2023. 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.

Previous wording

Under the Hercules Amendment, the Lenders provided the Company access to an increased term loan with an aggregate principal amount of up to $150 million, in four tranches (collectively the “Amended Term Loan”), consisting of (1) an initial tranche of $50.0 million, $5.0 million of which was drawn at closing of the Hercules Loan and Security Agreement in April 2022, $15.0 million of which was drawn at closing of the Hercules Amendment in August 2023, $5.0 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; (2) a second tranche of $20.0 million, subject to achievement of certain regulatory milestones, which was available through February 15, 2025; (3) a third tranche of $20.0 million, subject to achievement of certain regulatory milestones, which was available through March 31, 2025; and (4) a fourth tranche of $60.0 million subject to approval by the Lenders’ investment committee(s), available through June 15, 2025. The obligations of the Borrower under the Hercules Amendment agreement are secured by substantially all of the assets of the Borrower, excluding the Borrower’s intellectual property. The Amended Term Loan has a maturity date of October 1, 2026.

Current wording

Under the Hercules Amendment, the Lenders provided the Company access to an increased term loan with an aggregate principal amount of up to $150 million, in four tranches (collectively the “Amended Term Loan”), consisting of (1) an initial tranche of $50.0 million, $5.0 million of which was drawn at closing of the Hercules Loan and Security Agreement in April 2022, $15.0 million of which was drawn at closing of the Hercules Amendment in August 2023, $5.0 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; (2) a second tranche of $20.0 million, subject to achievement of certain regulatory milestones, which was available through February 15, 2025; (3) a third tranche of $20.0 million, subject to achievement of certain regulatory milestones, which was available through March 31, 2025; and (4) a fourth tranche of $60.0 million subject to approval by the Lenders’ investment committee(s), which was available through June 15, 2025. The obligations of the Borrower under the Hercules Amendment agreement are secured by substantially all of the assets of the Borrower, excluding the Borrower’s intellectual property. The Amended Term Loan has a maturity date of October 1, 2026.

Previous wording

2024, the interest-only period was extended to October 1, 2025. Upon achievement of certain development milestones related to topline results for our phase 3 THRIVE-2 trial in December 2024, the interest-only period was further extended to April 1, 2026. The Borrower is required to repay the Amended Term Loan amount in equal monthly installments of the principal amount and interest between the end of the interest-only period and the maturity date of October 1, 2026. In addition, the Borrower is required to pay an end-of-term fee equal to 6% of the principal amount of funded Amended Term Loan advances at maturity, which are being accreted as additional interest expense over the term of the loan.

Current wording

Per the terms of the Hercules Amendment, we were originally obligated to make interest-only payments through April 1, 2025. Upon achievement of certain development milestones related to our topline results for our phase 3 THRIVE trial in September 2024, the interest-only period was extended to October 1, 2025. Upon achievement of certain development milestones related to topline results for our phase 3 THRIVE-2 trial in December 2024, the interest-only period was further extended to April 1, 2026. The Borrower is required to repay the Amended Term Loan amount in equal monthly installments of the principal amount and interest between the end of the interest-only period and the maturity date of October 1, 2026. In addition, the Borrower is required to pay an end-of-term fee equal to 6% of the principal amount of funded Amended Term Loan advances at maturity, which are being accreted as additional interest expense over the term of the loan.

Previous wording

In September 2022, we entered into an Open Market Sale Agreement SM (the “September 2022 ATM Agreement”) with Jefferies pursuant to which we could offer and sell shares of our common stock having an aggregate offering price of up to $175.0 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 the sales agent. Jefferies received a commission of up to 3.0% of the gross proceeds of any shares of common stock sold under the September 2022 ATM Agreement. During the year ended December 31, 2024, the Company sold 3,058,751 shares under the September 2022 ATM Agreement with Jefferies at a weighted average price of $22.86 per share, for aggregate net proceeds of approximately $67.7 million, including commissions to Jefferies as a sales agent. During the three months ended March 31, 2025, we sold 245,388 shares under the September 2022 ATM Agreement with Jefferies at a weighted average price of $20.14 per share, for aggregate net proceeds of approximately $4.8 million, including commissions to Jefferies as a sales agent.

Current wording

In September 2022, we entered into an Open Market Sale Agreement SM (the “September 2022 ATM Agreement”) with Jefferies pursuant to which we could offer and sell shares of our common stock having an aggregate offering price of up to $175.0 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 the sales agent. Jefferies received a commission of up to 3.0% of the gross proceeds of any shares of common stock sold under the September 2022 ATM Agreement. During the year ended December 31, 2024, the Company sold 3,058,751 shares under the September 2022 ATM Agreement with Jefferies at a weighted average price of $22.86 per share, for aggregate net proceeds of approximately $67.7 million, including commissions to Jefferies as a sales agent. During the six months ended June 30, 2025, we sold 245,388 shares under the September 2022 ATM Agreement with Jefferies at a weighted average price of $20.14 per share, for aggregate net proceeds of approximately $4.8 million, including commissions to Jefferies as a sales agent. During the three months ended June 30, 2025, there were no sales under the September 2022 ATM Agreement.

Previous wording

In March 2025, we entered into an Open Market Sale Agreement SM (the “March 2025 ATM Agreement”) with 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 months ended March 31, 2025. In connection with entering the March 2025 ATM Agreement, the September 2022 ATM Agreement described above was terminated in March 2025 and no further offerings or sales of common stock will be conducted under the September 2022 ATM Agreement.

Current wording

In March 2025, we entered into an Open Market Sale Agreement SM (the “March 2025 ATM Agreement”) with 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. During the three and six months ended June 30, 2025, there were no sales under the March 2025 ATM Agreement. In connection with entering the March 2025 ATM Agreement, the September 2022 ATM Agreement described above was terminated in March 2025 and no further offerings or sales of common stock will be conducted under the September 2022 ATM Agreement.

Previous wording

Summarized cash flows for the three months ended March 31, 2025 and 2024 are as follows:

Current wording

Summarized cash flows for the six months ended June 30, 2025 and 2024 are as follows:

Previous wording

Net cash used in operating activities was $92.7 million for the three months ended March 31, 2025, and primarily consisted of our net loss of $86.9 million, adjusted for non-cash items of $8.1 million (primarily share-based compensation of $10.2 million, offset by the 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 an 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 our net loss of $187.6 million, adjusted for non-cash items of $17.6 million (primarily share-based compensation of $21.1 million, offset by the 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 to vendors for ongoing clinical trial and manufacturing activities.

Previous wording

Net cash used in operating activities was $45.2 million for the three months ended March 31, 2024, and primarily consisted of a net loss of $48.5 million, adjusted for non-cash items of $8.3 million (primarily share-based compensation of $12.7 million, partially offset by accretion and amortization of premiums and discounts on available-for-sale securities of $4.7 million) and changes in working capital of $5.0 million. The change in working capital was primarily related to a net decrease of $0.4 million in accounts payable and accrued and other liabilities and an increase of $4.5 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 $91.3 million for the six months ended June 30, 2024, and primarily consisted of a net loss of $113.5 million, adjusted for non-cash items of $16.1 million (primarily share-based compensation of $24.5 million, partially offset by accretion and amortization of premiums and discounts on available-for-sale securities of $9.1 million) and changes in working capital of $6.2 million. The change in working capital was primarily related to a net increase of $7.6 million in accounts payable and accrued and other liabilities and an increase of $1.3 million in prepaid expenses and other current assets due to the timing of payments to vendors for ongoing clinical trial and manufacturing activities.

Previous wording

Net cash provided by investing activities was $100.1 million during the three months ended March 31, 2025, and consisted primarily of $100.1 million in net maturities of short-term investments.

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 short-term investments.

Previous wording

Net cash used in investing activities was $143.0 million during the three months ended March 31, 2024, and consisted primarily of $143.0 million in net purchases of short-term investments.

Current wording

Net cash used in investing activities was $81.1 million during the six months ended June 30, 2024, and consisted primarily of $81.0 million in net purchases of short-term investments.

Previous wording

Net cash provided by financing activities was $9.2 million during the three months ended March 31, 2025, and consisted of 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 of 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.

Previous wording

Net cash provided by financing activities was $177.1 million during the three months ended March 31, 2024, and consisted primarily of net proceeds of $175.9 million from the January 2024 Public Offering and the September 2022 ATM Agreement, as well as $0.8 million in proceeds from the exercise of stock options and $0.4 million in proceeds from the issuance of common stock under our employee stock purchase plan.

Current wording

Net cash provided by financing activities was $177.2 million during the six months ended June 30, 2024, and consisted primarily of net proceeds of $175.8 million from the January 2024 Public Offering and the September 2022 ATM Agreement, as well as $1.0 million in proceeds from the exercise of stock options and $0.4 million in proceeds from the issuance of common stock under our employee stock purchase plan.
Rearranged current paragraphs (10)

Current report — wording carried from elsewhere

•$9.0 million increase in chemistry, manufacturing, and controls costs to support IND-enabling activities for assets across the FcRn inhibitor portfolio; and

Current report — wording carried from elsewhere

•$2.3 million increase in market research and related costs to prepare for the potential commercialization of veligrotug;

Current report — wording carried from elsewhere

Revenue for both the six months ended June 30, 2025 and 2024 was attributable to our collaboration agreement with Zenas BioPharma.

Current report — wording carried from elsewhere

•$37.6 million increase in clinical trial costs and a $6.4 million increase in chemistry, manufacturing and controls costs to support the ongoing global phase 3 clinical trials for veligrotug and VRDN-003; partially offset by,

Current report — wording carried from elsewhere

•$2.2 million decrease in nonclinical research due to stage of development of the TED portfolio.

Current report — wording carried from elsewhere

•$7.2 million increase in personnel related costs, due primarily to increased headcount to support our ongoing research and development efforts, including share-based compensation and other employee compensation and recruiting costs; partially offset by,

Current report — wording carried from elsewhere

•$2.9 million decrease in severance costs primarily related to separation agreements with former executive officers, including a $1.6 million decrease in share-based compensation due to the acceleration of stock option vesting during the six months ended June 30, 2025 compared to the six months ended June 30, 2024.

Current report — wording carried from elsewhere

We expect our research and development expenses to remain consistent as we continue to advance our clinical and nonclinical programs.

Current report — wording carried from elsewhere

•$2.5 million increase in legal, accounting and other professional service fees to support the growing organization; partially offset by,

Current report — wording carried from elsewhere

Other income, net was $13.0 million during the six months ended June 30, 2025 compared to $14.5 million during the six months ended June 30, 2024. Other income, net for the six months ended June 30, 2025 is comprised of $14.1 million of interest income earned on short-term investments, partially offset by $1.1 million in interest expense related to our Hercules Loan and Security Agreement. Other income, net for the six months ended June 30, 2024 is comprised of $15.6 million of interest income earned on short-term investments as well as $0.2 million of sub-lease income, partially offset by $1.2 million in interest expense related to our Hercules Loan and Security Agreement.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

Per the terms of the Hercules Amendment, we were originally obligated to make interest-only payments through April 1, 2025. Upon achievement of certain development milestones related to our topline results for our phase 3 THRIVE trial in September