Dianthus Therapeutics, Inc. /DE/

Previous wording

We are a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases. We believe our lead novel and proprietary monoclonal antibody product candidate, claseprubart, has the potential to address a broad array of complement-dependent diseases as currently available therapies and those in development leave room for improvements in efficacy, safety, and/or dosing convenience. We have purposefully engineered claseprubart to selectively bind to only the active form of the C1s complement protein (“C1s”) and to exhibit improved potency and an extended half-life. By selectively targeting only the active form of C1s, which drives disease pathology and constitutes only a small fraction of the total protein present in circulation, we aim to reduce the amount of drug required for a therapeutic effect. We intend to deliver our product candidate through a lower dose, less frequent, self-administered, convenient subcutaneous (“S.C.”) injection suitable for a pre-filled pen.

Current wording

We are a clinical-stage biotechnology company dedicated to developing potentially best-in-disease therapies for patients living with severe autoimmune diseases. Our lead clinical-stage candidate, claseprubart, is a monoclonal antibody that is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein (“C1s”) – enabling less frequent and more convenient self-administered subcutaneous (“S.C.”) injections suitable for a pre-filled pen. Additionally, selective inhibition of the classical complement pathway may lower patient risk of infection from encapsulated bacteria by preserving immune activity of the lectin and alternative pathways. We believe claseprubart has the potential to address a broad array of complement-dependent diseases as currently available therapies and those in development leave room for improvements in efficacy, safety, and/or dosing convenience.

Previous wording

Our most advanced product candidate, claseprubart, is a clinical-stage, highly potent, highly selective and fully human monoclonal immunoglobulin G4 with picomolar binding affinity that is designed to selectively bind only to the active form of C1s. The active form of C1s is generated during complement activation by cleavage of the inactive proC1s. As a validated complement target in the autoimmune and inflammatory field, C1s inhibition prevents further progression of the classical pathway cascade. Claseprubart is engineered with YTE half-life extension technology, a specific three amino acid change in the Fc domain, and has a pharmacokinetic (“PK”) profile designed to support less frequent, lower dose, self-administration as a convenient S.C. injection. We are currently conducting three mid- to late-stage clinical trials with claseprubart in generalized Myasthenia Gravis (“gMG”), Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”), and Multifocal Motor Neuropathy (“MMN”).

Current wording

Our most advanced product candidate, claseprubart, is a clinical-stage, highly potent, highly selective and fully human monoclonal immunoglobulin G4 with picomolar binding affinity that is designed to selectively bind only to the active form of C1s. The active form of C1s is generated during complement activation by cleavage of the inactive proC1s. As a validated complement target in the autoimmune and inflammatory field, C1s inhibition prevents further progression of the classical pathway cascade. Claseprubart is engineered with YTE half-life extension technology, a specific three amino acid change in the Fc domain, and has a pharmacokinetic (“PK”) profile designed to support less frequent, lower dose, self-administration as a convenient S.C. injection.

Previous wording

The MaGic trial is a global, randomized, double-blind, placebo-controlled Phase 2 trial of claseprubart that enrolled 65 acetylcholine receptor positive (“AChR+”) participants with gMG. Following an initial loading dose, claseprubart was administered every two weeks (“Q2W”) via S.C. injection at a dose of 300mg/2mL or 600mg/4mL. The initial randomized treatment duration was 13 weeks, followed by a 52-week open-label extension. The primary endpoint of the study was safety and tolerability. Secondary and exploratory efficacy endpoints included Myasthenia Gravis Activities of Daily Living Scale (“MG-ADL”) and Quantitative Myasthenia Gravis (“QMG”) score assessments, as well as Minimal Symptom Expression (“MSE”), Myasthenia Gravis Composite (“MGC”) score, and the Myasthenia Gravis Quality of Life Scale (“MG-QOL-15r”).

Current wording

The MaGic trial is a global, randomized, double-blind, placebo-controlled Phase 2 trial of claseprubart that enrolled 65 acetylcholine receptor positive (“AChR+”) participants with gMG. Following an initial loading dose, claseprubart was administered every two weeks (“Q2W”) via S.C. injection at a dose of 300mg/2mL or 600mg/4mL. The initial randomized treatment duration was 13 weeks, followed by a 52-week open-label extension (“OLE”). The primary endpoint of the study was safety and tolerability. Secondary and exploratory efficacy endpoints included Myasthenia Gravis Activities of Daily Living Scale (“MG-ADL”) and Quantitative Myasthenia Gravis (“QMG”) score assessments, as well as Minimal Symptom Expression (“MSE”), Myasthenia Gravis Composite (“MGC”) score, and the Myasthenia Gravis Quality of Life Scale (“MG-QOL-15r”).

Previous wording

Claseprubart was generally well tolerated with no drug-related Serious Adverse Events or discontinuations due to any related adverse event. Claseprubart had a favorable clinical safety profile comparable to placebo with no treatment-related serious bacterial infections and no clinical symptoms of emergent autoimmune disorders observed.

Current wording

Claseprubart was generally well tolerated with no drug-related serious adverse events (“SAE”) or discontinuations due to any related adverse event. Claseprubart had a favorable clinical safety profile comparable to placebo with no treatment-related serious bacterial infections and no clinical symptoms of emergent autoimmune disorders observed.

Previous wording

The CAPTIVATE trial is a single, two-part, randomized withdrawal global Phase 3 trial of claseprubart in patients with CIDP. In the open label Part A of this trial, participants will be administered claseprubart with a loading dose followed by 300mg/2mL administered Q2W via S.C. injection for up to 13 weeks. Part A includes an interim responder analysis of the first 40 participants enrolled in Part A. Only participants who respond to claseprubart in Part A, as measured as greater than or equal to one point decrease (improvement) in adjusted Inflammatory Neuropathy Cause and Treatment (“INCAT”) disability score compared to Part A baseline, will be randomized into Part B, a double-blind, placebo-controlled treatment period of up to 52 weeks, where they will be assessed for prevention of relapse, safety and tolerability, followed by an open-label extension period. We believe that this single pivotal trial will support a Biologics License Application (“BLA”) filing in adult patients with CIDP. We anticipate completing an interim responder analysis of the first 40 participants in Part A in the second quarter of 2026.

Current wording

The CAPTIVATE trial is a single, two-part, randomized withdrawal global Phase 3 trial of claseprubart in patients with CIDP. In the open label Part A of this trial, participants will be administered claseprubart with a loading dose followed by 300mg/2mL administered Q2W via S.C. injection for up to 13 weeks. Only participants who respond to claseprubart in Part A, as measured as greater than or equal to one point decrease (improvement) in adjusted Inflammatory Neuropathy Cause and Treatment (“INCAT”) disability score compared to Part A baseline, are randomized into Part B, a double-blind, placebo-controlled treatment period of up to 52 weeks, where they will be assessed for prevention of relapse, safety and tolerability, followed by an OLE period. Part A included an interim responder analysis of the first 40 participants to complete Part A. Our target for the Part A interim responder analysis was a response rate of 50% or greater (i.e., ≥20 confirmed responders out of first 40 participants to complete Part A) based on precedent set with aC1s inhibition.

Previous wording

The MoMeNtum trial is a global, randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the safety, tolerability, and efficacy of claseprubart in 36 patients with MMN. Following determination of Ig dependency and responsiveness, patients will be randomized to receive placebo or claseprubart with a loading dose followed by 300mg/2mL or 600mg/4mL administered Q2W via S.C. injection. The initial S.C. treatment duration is 17 weeks followed by a 52-week open-label extension. The primary endpoint of this study is safety and tolerability. Secondary endpoints include time to intravenous immunoglobulin (“IVIg”) retreatment, time to relapse, and assessments of muscle and grip strength. We anticipate initial top-line results from this trial to be available in the second half of 2026.

Current wording

The MoMeNtum trial is a global, randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the safety, tolerability, and efficacy of claseprubart in 36 patients with MMN. Following determination of immunoglobulin (“Ig”) dependency and responsiveness, patients will be randomized to receive placebo or claseprubart with a loading dose followed by 300mg/2mL or 600mg/4mL administered Q2W via S.C. injection. The initial S.C. treatment duration is 17 weeks followed by a 52-week OLE. The primary endpoint of this study is safety and tolerability. Secondary endpoints include time to intravenous immunoglobulin (“IVIg”) retreatment, time to relapse, and assessments of muscle and grip strength. We anticipate initial top-line results from this trial to be available in the fourth quarter of 2026.

Previous wording

Our First and Potentially Best-In-Class Bifunctional BDCA2 and BAFF/APRIL Inhibitor (DNTH212)

Current wording

Our First-In-Class and Potentially Best-In-Disease Bifunctional BDCA2 and BAFF/APRIL Inhibitor (DNTH212)

Previous wording

On October 16, 2025, we entered into an exclusive license agreement with Nanjing Leads Biolabs Co., Ltd. (“Leads”) for DNTH212, a first and potentially best-in-class bifunctional BDCA2 and BAFF/APRIL inhibitor.

Current wording

On October 16, 2025, we entered into an exclusive license agreement with Nanjing Leads Biolabs Co., Ltd. (“Leads”) for DNTH212, a first-in-class and potentially best-in-disease bifunctional BDCA2 and BAFF/APRIL inhibitor.

Previous wording

A two-part Phase 1 study in China in healthy volunteers (Part A) and patients with systemic lupus erythematosus (Part B) is expected to initiate by year-end 2025, with top-line results in healthy volunteers expected in the second half of 2026.

Current wording

A two-part Phase 1 study in China in healthy volunteers (Part A) and patients with Systemic Lupus Erythematosus (Part B) was initiated in December 2025, with top-line results in healthy volunteers expected in the second half of 2026.

Previous wording

Uncertainty in the global economy presents significant risks to our business. We are subject to continuing risks and uncertainties in connection with legislative, regulatory, political, geopolitical and macroeconomic developments beyond our control, including inflationary pressures, general economic slowdown or a recession, high interest rates, changes in monetary policy or foreign currency exchange rates, changes in trade policies, including tariffs and other trade restrictions or the threat of such actions, instability in financial institutions, the ongoing conflict in Ukraine, conflicts in the Middle East, rising tensions between China and Taiwan, the attacks on marine vessels traversing the Red Sea and the responses thereto, and supply chain disruptions. While we are closely monitoring the impact of the current macroeconomic conditions on all aspects of our business, including the impacts on participants in our clinical trials, employees, suppliers, vendors, business partners and regulators, the ultimate extent of the impact on our business remains highly uncertain and will depend on future developments and factors that continue to evolve. Most of these developments and factors are outside of our control and could exist for an extended period of time. We will continue to evaluate the nature and extent of the potential impacts to Dianthus’ business, results of operations, liquidity and capital resources. For additional information, see the section titled “Risk Factors” found elsewhere in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 11, 2025.

Current wording

Uncertainty in the global economy presents significant risks to our business. We are subject to continuing risks and uncertainties in connection with legislative, regulatory, political, geopolitical and macroeconomic developments beyond our control, including inflationary pressures, general economic slowdown or a recession, high interest rates, changes in monetary policy or foreign currency exchange rates, changes in trade policies, including tariffs and other trade restrictions or the threat of such actions, instability in financial institutions, the ongoing conflict in Ukraine, conflicts in the Middle East, rising tensions between China and Taiwan, the attacks on marine vessels traversing the Red Sea and the responses thereto, volatility in oil and other commodity prices, and supply chain disruptions. While we are closely monitoring the impact of the current macroeconomic conditions on all aspects of our business, including the impacts on participants in our clinical trials, employees, suppliers, vendors, business partners and regulators, the ultimate extent of the impact on our business remains highly uncertain and will depend on future developments and factors that continue to evolve. Most of these developments and factors are outside of our control and could exist for an extended period of time. We will continue to evaluate the nature and extent of the potential impacts to our business, results of operations, liquidity and capital resources. For additional information, see the section titled “Risk Factors” found elsewhere in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 9, 2026.

Previous wording

The consideration under the Tenacia License Agreement, which replaced the consideration of the Zenas License Agreement, related to the first antibody sequence includes the following payments by Tenacia to us: (i) a $2.5 million upfront payment, which was paid by Tenacia to us in October 2024 upon execution of the Tenacia License Agreement; (ii) reimbursement of a portion of certain clinical costs; (iii) development milestones totaling up to $15.0 million; and (iv) royalties on net sales ranging from the mid-single digits to the low teen percentages. Tenacia is also responsible for paying local development costs in Greater China and a portion of central development costs based on the number of patients enrolled from China in our global Phase 3 studies. No milestones were achieved under the Zenas Agreements prior to novation. During the nine months ended September 30, 2025, we achieved $6.0 million of milestone payments under the Tenacia Agreements (as defined below), which were added to the transaction price. We had not recorded any royalty revenue under the Zenas Agreement prior to novation, and we have not recorded any royalty revenue under the Tenacia Agreements.

Current wording

The consideration under the Tenacia License Agreement, which replaced the consideration of the Zenas License Agreement, related to the first antibody sequence includes the following payments by Tenacia to us: (i) a $2.5 million upfront payment, which was paid by Tenacia to us in October 2024 upon execution of the Tenacia License Agreement; (ii) reimbursement of a portion of certain clinical costs; (iii) development milestones totaling up to $15.0 million; and (iv) royalties on net sales ranging from the mid-single digits to the low teen percentages. Tenacia is also responsible for paying local development costs in Greater China and a portion of central development costs based on the number of patients enrolled from China in our global Phase 3 studies. No milestones were achieved under the Zenas Agreements prior to novation. As of March 31, 2026, $7.0 million of cumulative milestones were achieved under the Tenacia Agreements (as defined below) and added to the transaction price. We had not recorded any royalty revenue under the Zenas Agreement prior to novation, and we have not recorded any royalty revenue under the Tenacia Agreements.

Previous wording

During the three and nine months ended September 30, 2025, we recognized license revenue totaling $0.4 million and $1.8 million, respectively, related to the Tenacia Agreements.

Current wording

During the three months ended March 31, 2026 and 2025, we recognized license revenue totaling $0.5 million and $1.2 million, respectively, related to the Tenacia Agreements.

Previous wording

Research and development expenses account for a significant portion of our operating expenses and consist primarily of external and internal expenses incurred in connection with the discovery and development of claseprubart and other potential product candidates.

Current wording

Research and development expenses account for a significant portion of our operating expenses and consist primarily of external and internal expenses incurred in connection with the discovery and development of claseprubart, DNTH212, and other potential product candidates.

Previous wording

Under the terms of the Zenas Agreements, we recognized related party license revenue of nil and $2.2 million during the three months ended September 30, 2025 and 2024, respectively. Additionally, under the terms of the Tenacia Agreements, we recognized license revenue of $0.4 million and nil for the three months ended September 30, 2025 and 2024, respectively.

Current wording

Under the terms of the Tenacia Agreements, we recognized license revenue of $0.5 million and $1.2 million during the three months ended March 31, 2026 and 2025, respectively.

Previous wording

The decrease in total revenues was due to a decrease in reimbursable costs associated with claseprubart’s ongoing clinical trials that were subject to the Zenas Agreements and are now subject to the Tenacia Agreements.

Current wording

The decrease in total revenues was due to a decrease in reimbursable costs associated with claseprubart’s ongoing clinical trials.

Previous wording

Research and development expenses were $32.5 million for the three months ended September 30, 2025, as compared to $25.5 million for the three months ended September 30, 2024, an increase of $7.0 million. This increase was due to: (1) a $4.0 million increase in external research and development costs, consisting of clinical operations activities, CMC activities, preclinical study costs, discovery expenses, and licensing and milestone expenses related to claseprubart; and (2) a $3.0 million increase in internal research and development costs, consisting of personnel and related costs, stock-based compensation expense and other costs.

Current wording

Research and development expenses were $34.5 million for the three months ended March 31, 2026, as compared to $27.0 million for the three months ended March 31, 2025, an increase of $7.5 million. This increase was due to: (1) a $2.1 million increase in external research and development costs, consisting of clinical operations activities, CMC activities, preclinical study costs, discovery expenses, and licensing and milestone expenses related to claseprubart; and (2) a $5.4 million increase in internal research and development costs, consisting of personnel and related costs, stock-based compensation expense and other costs.

Previous wording

The $4.0 million increase in external research and development costs was due to a $4.6 million increase in expenses related to our lead product candidate, claseprubart, partially offset by a $0.6 million decrease in discovery activities. For the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, the increase in claseprubart related expense was due to $4.8 million in clinical operations activities and $2.0 million in licensing and milestone expenses, partially offset by decreases of $1.6 million in preclinical study costs and $0.6 million in CMC activities. The increased costs of clinical operations activities and licensing and milestone expenses were due to activities related to claseprubart’s ongoing Phase 2 clinical trials in gMG and MMN and Phase 3 clinical trial in CIDP.

Current wording

The $2.1 million increase in external research and development costs was due to a $1.6 million increase in expenses related to our lead product candidate, claseprubart, and a $0.5 million increase in discovery activities including those related to DNTH212. For the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, the increase in claseprubart related expense was due to $2.5 million in clinical operations activities, partially offset by decreases of $0.8 million in preclinical study costs and $0.1 million in CMC activities. The increased costs of clinical operations activities were due to activities related to claseprubart’s ongoing Phase 2 clinical trials in gMG and MMN and Phase 3 clinical trial in CIDP.

Previous wording

The $3.0 million increase in internal research and development costs was due to increases of $1.9 million in personnel and related costs, $0.8 million in stock-based compensation expense, and $0.3 million in other costs. The increase in costs was primarily due to increases in headcount and related expenses to support our ongoing Phase 2 and Phase 3 clinical trials.

Current wording

The $5.4 million increase in internal research and development costs was due to increases of $2.8 million in personnel and related costs, $2.4 million in stock-based compensation expense, and $0.2 million in other costs. The increases were due to the buildout of our internal research and development function to support our Phase 2 and Phase 3 clinical trials in claseprubart and development of DNTH212.

Previous wording

General and administrative expenses were $8.2 million for the three months ended September 30, 2025, as compared to $6.5 million for the three months ended September 30, 2024, an increase of $1.7 million. The increase was primarily due to increases of $1.1 million in stock-based compensation expense and $0.6 million in personnel-related costs. The increase in costs was primarily due to increases in headcount and related expenses.

Current wording

General and administrative expenses were $12.5 million for the three months ended March 31, 2026, as compared to $7.3 million for the three months ended March 31, 2025, an increase of $5.2 million. The increase was primarily due to increases of $2.9 million in stock-based compensation expense, $1.5 million in personnel-related costs and $0.8 million in other administrative expenses. The increase in costs was primarily due to increases in headcount and related expenses.

Previous wording

Other income was $3.5 million for the three months ended September 30, 2025, as compared to $4.7 million for the three months ended September 30, 2024, a decrease of $1.2 million. The decrease was primarily due to higher cash and investment balances in the prior comparable period.

Current wording

Other income was $5.7 million for the three months ended March 31, 2026, as compared to $3.7 million for the three months ended March 31, 2025, an increase of $2.0 million. The increase was primarily due to higher cash and investment balances in the current period as compared to the prior period.

Previous wording

Since inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from operations. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our lead product candidate, claseprubart, DNTH212, or any other future product candidates. We expect that our research and development and general and administrative costs will continue to increase significantly, including in connection with conducting clinical trials and manufacturing for our lead product candidate, claseprubart, DNTH212, or any other future product candidates to support potential future commercialization and providing general and administrative support for our operations, including the costs associated with operating as a public company. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements or other sources. See the section titled “Risk Factors” found elsewhere in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 11, 2025 for additional risks associated with our substantial capital requirements.

Current wording

Since inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from operations. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our lead product candidate, claseprubart, DNTH212, or any other future product candidates. We expect that our research and development and general and administrative costs will continue to increase significantly, including in connection with conducting clinical trials and manufacturing for our lead product candidate, claseprubart, DNTH212, or any other future product candidates to support potential future commercialization and providing general and administrative support for our operations, including the costs associated with operating as a public company. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements or other sources. See the section titled “Risk Factors” included elsewhere in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 9, 2026 for additional risks associated with our substantial capital requirements.

Previous wording

We have an open market sales agreement (the “ATM Agreement”) pursuant to which we may sell, from time to time shares of our common stock under an at-the-market (“ATM”) offering for an aggregate sales price of up to $200 million. Any sales of our common stock pursuant to the ATM Agreement are made under our registration statement on Form S-3 which was deemed effective by the SEC on October 9, 2024. To date, we have sold 1,503,708 shares of our common stock under the ATM offering program, with $160.8 million in remaining capacity under the ATM offering program.

Current wording

We have an open market sales agreement (the “ATM Agreement”) pursuant to which we may sell, from time-to-time shares of our common stock under an at-the-market (“ATM”) offering for an aggregate sales price of up to $200 million. Any sales of our common stock pursuant to the ATM Agreement are made under our registration statement on Form S-3 which was deemed effective by the SEC on October 9, 2024. As of March 31, 2026, we have sold 2,626,834 shares of our common stock under the ATM offering program and have $100.1 million in remaining capacity under the ATM offering program.

Previous wording

To date, we have funded our operations primarily through public offerings for gross proceeds of $288.4 million, private placements of capital stock for gross proceeds of $423.5 million, and net proceeds of $39.2 million from our ATM offering program.

Current wording

We historically have funded our operations with proceeds from the sale of capital stock. As of the date of this filing, we have raised aggregate gross proceeds of $1.0 billion from public offerings, $423.5 million from private placements, and $99.9 million from our ATM offering program.

Previous wording

Since inception, we have devoted substantially all of our resources to conducting research and development activities (including with respect to the claseprubart program) and undertaking preclinical studies, conducting clinical trials and the manufacturing of the product used in our clinical trials and preclinical studies, business planning, developing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these activities.

Current wording

Since inception, we have devoted substantially all of our resources to conducting research and development activities (including with respect to the claseprubart program and DNTH212) and undertaking preclinical studies, conducting clinical trials and the manufacturing of the product used in our clinical trials and preclinical studies, business planning, developing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these activities.

Previous wording

To date, we have funded our operations primarily with proceeds from the sale of capital stock and have raised aggregate gross proceeds of $288.4 million from public offerings, $423.5 million from private placements, and net proceeds of $39.2 million from our ATM offering program. However, we have incurred significant recurring losses. We generated net losses of $97.9 million and $56.5 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $272.3 million. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on a variety of factors, including the timing, scope and results of our research and development activities. As of September 30, 2025, we had cash, cash equivalents and investments of $555.5 million. Based on our current operating plan, we believe that our existing cash, cash equivalents and investments should be sufficient to fund our operations into 2028. Until we achieve profitability, we plan to fund our operations and capital expenditures with cash on hand and expect to seek to raise any necessary additional capital through private or public equity or debt financings, loans or other capital sources, which could include income from collaborations, partnerships or other marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. There can be no assurance that we will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to us.

Current wording

Historically, we have funded our operations with proceeds from the sale of capital stock. As of the date of this filing, we have raised aggregate gross proceeds of $1.0 billion from public offerings, $423.5 million from private placements, and $99.9 million from our ATM offering program. However, we have incurred significant recurring losses. We generated net losses of $40.8 million and $29.5 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $377.6 million. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on a variety of factors, including the timing, scope and results of our research and development activities. As of March 31, 2026, we had cash, cash equivalents and investments of $1.2 billion. Based on our current operating plan, we believe that our existing cash, cash equivalents and investments as of March 31, 2026 should be sufficient to fund our operations into 2030. Until we achieve profitability, we plan to fund our operations and capital expenditures with cash on hand and expect to seek to raise any necessary additional capital through private or public equity or debt financings, loans or other capital sources, which could include income from collaborations, partnerships or other marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. There can be no assurance that we will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to us.

Previous wording

For the nine months ended September 30, 2025, net cash used in operating activities consisted of a net loss of $97.9 million, partially offset by a decrease in net operating assets and liabilities of $4.2 million and net non-cash operating expenses of $11.5 million. The decrease in net operating assets and liabilities was attributable to increases in accounts payable, accrued expenses and operating lease liabilities of $4.6 million and deferred revenue of $4.6 million and decreases in a receivable from Zenas of $0.8 million and other assets of $0.6 million, partially offset by an increase in accounts receivable of $5.0 million and prepaid expenses and other current assets of $1.4 million. The non-cash operating expenses consisted primarily of stock-based compensation expense of $16.8 million and amortization of right-of-use operating lease assets of $0.3 million, partially offset by accretion of discount on investment securities of $5.3 million and a gain on an investment in related party of $0.3 million.

Current wording

For the three months ended March 31, 2026, net cash used in operating activities consisted of a net loss of $40.8 million, partially offset by a decrease in net operating assets and liabilities of $2.2 million and net non-cash operating expenses of $9.8 million. The decrease in net operating assets and liabilities was attributable to increases in accounts payable, accrued expenses and operating lease liabilities of $7.0 million and deferred revenue of $0.8 million, partially offset by increases in accounts receivable of $1.2 million, prepaid expenses and other current assets of $2.3 million and other assets of $2.1 million. The non-cash operating expenses consisted primarily of stock-based compensation expense of $10.6 million, a loss on an investment in a former related party of $0.3 million and amortization of right-of-use operating lease assets of $0.1 million, partially offset by accretion of discount on investment securities of $1.2 million.

Previous wording

For the nine months ended September 30, 2024, net cash used in operating activities consisted of a net loss of $56.5 million, partially offset by a decrease in net operating assets and liabilities of $0.1 million and net non-cash operating expenses of $5.7 million. The decrease in net operating assets and liabilities was primarily attributable to an increase in accounts payable, accrued expenses and operating lease liabilities of $5.9 million, partially offset by increases in other assets of $3.1 million, unbilled receivable from Zenas of $1.1 million, receivable from Zenas of $1.1 million and prepaid expenses and other current assets of $0.4 million and a decrease in deferred revenue of $0.1 million. The non-cash operating expenses consisted primarily of stock-based compensation expense of $9.0 million and amortization of right-of-use operating lease assets of $0.3 million, partially offset by accretion of discount on investment securities of $3.3 million and a gain on an investment in related party of $0.3 million.

Current wording

For the three months ended March 31, 2025, net cash used in operating activities consisted of a net loss of $29.5 million and an increase in net operating assets and liabilities of $1.6 million, partially offset by net non-cash operating expenses of $3.5 million. The increase in net operating assets and liabilities was primarily attributable to increases in prepaid expenses and other current assets of $1.9 million, accounts receivable of $1.0 million and decreases in accounts payable, accrued expenses and operating lease liabilities of $1.5 million, partially offset by decreases in other assets of $2.0 million and related party receivable from Zenas of $0.8 million. The non-cash operating expenses consisted primarily of stock-based compensation expense of $5.3 million and amortization of right-of-use operating lease assets of $0.1 million, partially offset by accretion of discount on investment securities of $1.9 million.

Previous wording

For the nine months ended September 30, 2025, net cash used in investing activities consisted primarily of $380.3 million of purchases of investment securities, partially offset by $220.3 million in proceeds from maturities of investment securities.

Current wording

For the three months ended March 31, 2026, net cash used in investing activities consisted primarily of $238.6 million of purchases of investment securities, partially offset by $104.6 million in proceeds from sales and maturities of investment securities.

Previous wording

For the nine months ended September 30, 2024, net cash used in investing activities consisted primarily of $305.6 million of purchases of investment securities, partially offset by $42.0 million of proceeds from maturities of investment securities.

Current wording

For the three months ended March 31, 2025, net cash provided by investing activities consisted primarily of $82.1 million in proceeds from sales and maturities of investment securities, partially offset by $67.3 million of purchases of investment securities.

Previous wording

For the nine months ended September 30, 2025, net cash provided by financing activities consisted primarily of $272.1 million of net proceeds from the public offering, $2.8 million of proceeds from the exercise of stock options and $0.3 million of proceeds from common stock issued under our ESPP.

Current wording

For the three months ended March 31, 2026, net cash provided by financing activities consisted primarily of $676.3 million of net proceeds from a public offering, $58.7 million of proceeds from the ATM offering program, $4.3 million of proceeds from the exercise of stock options and $0.1 million of proceeds from common stock issued under our employee stock purchase plan.

Previous wording

For the nine months ended September 30, 2024, net cash provided by financing activities consisted of $215.3 million of net proceeds from the private placement and $0.6 million of proceeds from the exercise of stock options.

Current wording

For the three months ended March 31, 2025, net cash provided by financing activities consisted primarily of $0.1 million of proceeds from common stock issued under our employee stock purchase plan and $30 thousand of proceeds from the exercise of stock options.

Previous wording

In July 2020, we entered into a collaborative research agreement with IONTAS Limited (“IONTAS”) to perform certain milestone-based research and development activities under our first development program. The agreement was amended in January 2023 to extend services to additional development programs. We are obligated to pay development and commercial milestone payments of up to £5.4 million (approximately $7.3 million based on the September 30, 2025 exchange rate) with the first development program and of up to £2.5 million (approximately $3.4 million based on the September 30, 2025 exchange rate) with the second development program.

Current wording

In July 2020, we entered into a collaborative research agreement with IONTAS Limited (“IONTAS”) to perform certain milestone-based research and development activities under our first development program. We are obligated to pay development and commercial milestone payments of up to £5.4 million (approximately $7.1 million based on the March 31, 2026 exchange rate) with the first development program, which has been selected for the claseprubart program.

Previous wording

During the nine months ended September 30, 2025, there were no material changes to our critical accounting estimates from those disclosed in the audited consolidated financial statements for the year ended December 31, 2024 included in our Annual Report on Form 10-K filed with the SEC on March 11, 2025.

Current wording

During the three months ended March 31, 2026, there were no material changes to our critical accounting estimates from those disclosed in the audited consolidated financial statements for the year ended December 31, 2025 included in our Annual Report on Form 10-K filed with the SEC on March 9, 2026.