Dianthus Therapeutics, Inc. /DE/

Previous wording

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

We are currently conducting mid- to late-stage clinical trials with claseprubart in generalized Myasthenia Gravis (“gMG”), Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”), and Multifocal Motor Neuropathy (“MMN”).

Previous wording

In September 2025, we reported positive top-line results from the Phase 2 MaGic trial of claseprubart for patients with gMG and subsequently held an end-of-Phase 2 meeting with the FDA in the first quarter of 2026. We expect to initiate a Phase 3 registrational trial in gMG in mid-2026 and report top-line results in the second half of 2028.

Current wording

In September 2025, we reported positive top-line results from the Phase 2 MaGic trial of claseprubart for patients with gMG and subsequently held an end-of-Phase 2 meeting with the FDA in the first quarter of 2026. In June 2026, we announced the initiation of the Phase 3 registrational EMERGE trial of claseprubart in gMG. We expect to report top-line results from this trial in the second half of 2028.

Previous wording

In March 2026, we made an early GO announcement in the interim responder analysis for our Phase 3 CAPTIVATE trial of claseprubart in patients with CIDP due to achieving a target of 20 confirmed responders with less than the planned 40 participants completing Part A. We expect to provide CAPTIVATE Part B top-line guidance by the end of 2026.

Current wording

In March 2026, we made an early GO announcement in the Interim Responder Analysis for our Phase 3 CAPTIVATE trial of claseprubart in patients with CIDP due to achieving a target of 20 confirmed responders with less than the planned 40 participants completing Part A. In June 2026, we announced a 75% response rate observed in Interim Responder Analysis from the first 40 participants completing Part A of the Phase 3 CAPTIVATE trial, exceeding the target response rate of 50% or greater based on precedent set with aC1s inhibition. The results were consistent and clinically meaningful across multiple efficacy measures. In addition, claseprubart was generally well tolerated with no related serious infections, no clinical symptoms of drug-induced lupus

Previous wording

Claseprubart is also being evaluated in the Phase 2 MoMeNtum trial for patients with MMN, and we anticipate initial top-line results from this trial will be available in the fourth quarter of 2026.

Current wording

Claseprubart is also being evaluated in the Phase 2 MoMeNtum trial for patients with MMN. In August 2026, we announced the completion of enrollment of the MoMeNtum trial, which exceeded its enrollment target of 36 patients, and top-line results with 46 patients are expected in December 2026.

Previous wording

Removal of anti-nuclear antibodies (“ANAs”) as a screening criteria, a common reason for screen failure across all three claseprubart programs;

Current wording

Removal of anti-nuclear antibodies (“ANAs”) as a screening criterion, a common reason for screen failure across all three claseprubart programs;

Previous wording

Reclassification of the hypothetical risk of Systemic Lupus Erythematosus to drug-induced lupus (“DIL”), a side effect in several classes of widely used medications characterized by the reversal of symptoms upon discontinuation of the precipitating medication.

Current wording

Reclassification of the hypothetical risk of Systemic Lupus Erythematosus to DIL, a side effect in several classes of widely used medications characterized by the reversal of symptoms upon discontinuation of the precipitating medication.

Previous 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.

Current wording

Claseprubart was generally well tolerated with no drug-related SAEs 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

In March 2026, we announced that we achieved our target of 20 confirmed responders in Part A early, with less than 40 participants completing Part A, which supported our plan to maintain the claseprubart 300mg/2mL S.C. Q2W dose in Part A; engage with regulators to remove the claseprubart 600mg/4mL S.C. Q2W arm from Part B; and enroll up to 256 patients (previously up to 480) in Part A to randomize 128 patients in Part B (previously 192). We expect to provide CAPTIVATE Part B top-line guidance by the end of 2026. We believe that this single pivotal trial will support a Biologics License Application (“BLA”) filing in adult patients with CIDP.

Current wording

In March 2026, we announced that we achieved our target of 20 confirmed responders in Part A early, with less than 40 participants completing Part A, which supported our plan to maintain the claseprubart 300mg/2mL S.C. Q2W dose in Part A; engage with regulators to remove the claseprubart 600mg/4mL S.C. Q2W arm from Part B; and enroll up to 256 patients (previously up to 480) in Part A to randomize 128 patients in Part B (previously 192). In June 2026, we announced a 75% response rate observed in Interim Responder Analysis from the first 40 participants completing Part A of the Phase 3 CAPTIVATE trial, exceeding the target response rate of 50% or greater based on precedent set with aC1s inhibition. The results were consistent and clinically meaningful across multiple efficacy measures. In addition, claseprubart was generally well tolerated with no related serious infections, no clinical symptoms of DIL, no related SAEs or discontinuations due to safety. We expect to provide CAPTIVATE Part B top-line guidance by the end of 2026. We believe that this single pivotal trial will support a Biologics License Application (“BLA”) filing in adult patients with CIDP.

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 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.

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. In August 2026, we announced the completion of enrollment of the MoMeNtum trial, which exceeded its enrollment target of 36 patients, and top-line results with 46 patients are expected in December 2026.

Previous 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.

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 Phase 1 healthy volunteer data anticipated by year-end 2026.

Previous wording

On October 21, 2024, Zenas assigned the Zenas License Agreement to its affiliated entity, Zenas BioPharma (HK) Limited (“Zenas HK”). After the assignment, we entered into a novation agreement (the “Novation Agreement”) with Zenas HK and Tenacia Biotechnology (Hong Kong) Co., Limited (“Tenacia”) and an amendment to the Zenas License Agreement, now with Tenacia (as amended, the “Tenacia License Agreement”), pursuant to which Tenacia replaced Zenas HK as a party to the Zenas Agreements and certain economic terms under the Zenas License Agreement with respect to cost sharing and development milestones were amended.

Current wording

On October 21, 2024, Zenas assigned the Zenas License Agreement to its affiliated entity, Zenas BioPharma (HK) Limited (“Zenas HK”). After the assignment, we entered into a novation agreement (the “Novation Agreement”) with Zenas HK and Tenacia Biotechnology (Hong Kong) Co., Limited (“Tenacia”) and an amendment to the Zenas License Agreement, now with Tenacia (as amended, the “Tenacia License Agreement”), pursuant to which Tenacia replaced Zenas HK as a party to the Zenas License Agreement and an Option Agreement which we entered into with Zenas on September 2020 (together, the “Zenas Agreements”) and certain economic terms under the Zenas License Agreement with respect to cost sharing and development milestones were amended.

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. 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.

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 June 30, 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 Agreements prior to novation, and we have not recorded any royalty revenue under the Tenacia Agreements.

Previous 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.

Current wording

During the three and six months ended June 30, 2026, we recognized license revenue totaling $0.8 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, DNTH212, 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, DNTH312, and other potential product candidates.

Previous wording

Product candidates in later stages of development generally have higher development costs than those in earlier stages. As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance claseprubart into larger and later-stage clinical trials, develop DNTH212, work to discover and develop additional product candidates, seek to expand, maintain, protect and enforce our intellectual property portfolio and hire additional research and development personnel.

Current wording

Product candidates in later stages of development generally have higher development costs than those in earlier stages. As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance claseprubart into larger and later-stage clinical trials, develop DNTH212 and DNTH312, work to discover and develop additional product candidates, seek to expand, maintain, protect and enforce our intellectual property portfolio and hire additional research and development personnel.

Previous wording

The successful development of claseprubart, DNTH212, or any other future product candidates, if any, is highly uncertain, and we do not believe it is possible at this time to accurately project the nature, timing and estimated costs of the efforts necessary to complete the development of, and obtain regulatory approval for, claseprubart, DNTH212, or any other future product candidates, if any. To the extent claseprubart, DNTH212, or any other future product candidates advance into larger and later-stage clinical trials, our expenses will increase substantially and may become more variable. The duration, costs and timing of development of claseprubart, DNTH212, or any other future product candidates are subject to numerous uncertainties and will depend on a variety of factors, including:

Current wording

The successful development of claseprubart, DNTH212, DNTH312, or any other future product candidates, if any, is highly uncertain, and we do not believe it is possible at this time to accurately project the nature, timing and estimated costs of the efforts necessary to complete the development of, and obtain regulatory approval for, claseprubart, DNTH212, DNTH312, or any other future product candidates, if any. To the extent claseprubart, DNTH212, DNTH312, or any other future product candidates advance into larger and later-stage clinical trials, our expenses will increase substantially and may become more variable. The duration, costs and timing of development of claseprubart, DNTH212, DNTH312, or any other future product candidates are subject to numerous uncertainties and will depend on a variety of factors, including:

Previous wording

Any of these factors could significantly impact the costs, timing and viability associated with the development of claseprubart, DNTH212, or any other future product candidates.

Current wording

Any of these factors could significantly impact the costs, timing and variability associated with the development of claseprubart, DNTH212, DNTH312, or any other future product candidates.

Previous 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.

Current wording

Under the terms of the Tenacia Agreements, we recognized license revenue of $0.8 million and $0.2 million during the three months ended June 30, 2026 and 2025, respectively.

Previous 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.

Current wording

Research and development expenses were $48.7 million for the three months ended June 30, 2026, as compared to $26.3 million for the three months ended June 30, 2025, an increase of $22.4 million. This increase was due to: (1) a $15.1 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 $7.3 million increase in internal research and development costs, consisting of personnel and related costs, stock-based compensation expense and other costs.

Previous 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.

Current wording

The $15.1 million increase in external research and development costs was due to a $13.0 million increase in expenses related to our lead product candidate, claseprubart, and a $2.1 million increase in discovery activities including those related to DNTH212 and DNTH312. For the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, the increase in claseprubart related expense was due to increases of $7.8 million in clinical operations activities and $6.0 million in CMC activities, partially offset by decreases of $0.7 million in preclinical study costs and $0.1 million in other costs. The increased costs of clinical operations activities and CMC activities were due to activities related to claseprubart’s ongoing clinical trials in gMG, CIDP and MMN.

Previous 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.

Current wording

The $7.3 million increase in internal research and development costs was due to increases of $3.3 million in personnel and related costs, $3.2 million in stock-based compensation expense and $0.8 million in other research and development 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 and DNTH312.

Previous 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.

Current wording

General and administrative expenses were $13.6 million for the three months ended June 30, 2026, as compared to $8.9 million for the three months ended June 30, 2025, an increase of $4.7 million. The increase was primarily due to increases of $3.1 million in stock-based compensation expense, $1.3 million in personnel-related costs and $0.3 million in other administrative expenses. The increase in costs was primarily due to increases in headcount and related expenses.

Previous 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.

Current wording

Other income was $11.3 million for the three months ended June 30, 2026, as compared to $3.3 million for the three months ended June 30, 2025, an increase of $8.0 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” 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.

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, DNTH312, 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, DNTH312, 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. 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.

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 the date of this filing, we have sold 3,632,534 shares of our common stock under the ATM offering program, resulting in gross proceeds of $200.0 million, and have no remaining capacity under the ATM offering program.

Previous 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.

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 $200.0 million from our ATM offering program.

Previous wording

We have not generated any revenue from product sales. We do not expect to generate any meaningful product revenue unless and until we obtain regulatory approval of and commercialize claseprubart, DNTH212, or any other future product candidates, and we do not know when, or if, that will occur. In order to complete the development of claseprubart, DNTH212, or any other future product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize product candidates, if approved, we will require substantial additional capital. Accordingly, until such time that we can generate a sufficient amount of revenue from product sales or other sources, if ever, we 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. To the extent that we raise additional capital through equity financings, such as our ATM offering program, or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, including restricting our operations and limiting our ability to incur liens, issue additional debt, pay dividends, repurchase our common stock, make certain investments or engage in merger, consolidation, licensing, or asset sale transactions. If we raise capital through collaborations, partnerships, and other similar arrangements with third parties, we may be required to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. We may be unable to raise additional capital from these sources on favorable terms, or at all. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from bank failures, other general macroeconomic conditions and otherwise. Our failure to obtain sufficient capital on acceptable terms when needed could have a material adverse effect on our business, results of operations or financial condition, including requiring us to seek other alternatives which may include, among others, a delay or termination of our clinical trials or the development of our product candidates, temporary or permanent curtailment of our operations, a sale of our assets, or other alternatives with strategic or financial partners. We cannot provide assurance that we will ever generate positive ca…

Excerpt shortened here; the source contains the full paragraph.

Current wording

We have not generated any revenue from product sales. We do not expect to generate any meaningful product revenue unless and until we obtain regulatory approval of and commercialize claseprubart, DNTH212, or any other future product candidates, and we do not know when, or if, that will occur. In order to complete the development of claseprubart, DNTH212, or any other future product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize product candidates, if approved, we will require substantial additional capital. Accordingly, until such time that we can generate a sufficient amount of revenue from product sales or other sources, if ever, we 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. To the extent that we raise additional capital through equity financings, such as an ATM offering program, or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, including restricting our operations and limiting our ability to incur liens, issue additional debt, pay dividends, repurchase our common stock, make certain investments or engage in merger, consolidation, licensing, or asset sale transactions. If we raise capital through collaborations, partnerships, and other similar arrangements with third parties, we may be required to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. We may be unable to raise additional capital from these sources on favorable terms, or at all. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from bank failures, other general macroeconomic conditions and otherwise. Our failure to obtain sufficient capital on acceptable terms when needed could have a material adverse effect on our business, results of operations or financial condition, including requiring us to seek other alternatives which may include, among others, a delay or termination of our clinical trials or the development of our product candidates, temporary or permanent curtailment of our operations, a sale of our assets, or other alternatives with strategic or financial partners. We cannot provide assurance that we will ever generate positive cas…

Excerpt shortened here; the source contains the full paragraph.

Previous 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.

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 $200.0 million from our ATM offering program. However, we have incurred significant recurring losses. We generated net losses of $91.0 million and $61.1 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $427.8 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 June 30, 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 June 30, 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

the scope, timing, progress, results, and costs of researching and developing DNTH212 or any other future product candidates that we may pursue;

Current wording

the scope, timing, progress, results, and costs of researching and developing DNTH212, DNTH312, or any other future product candidates that we may pursue;

Previous 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.

Current wording

For the six months ended June 30, 2026, net cash used in operating activities consisted of a net loss of $91.0 million and an increase in net operating assets and liabilities of $2.8 million, partially offset by net non-cash operating expenses of $16.0 million. The increase in net operating assets and liabilities was attributable to increases in accounts receivable of $0.1 million, prepaid expenses and other current assets of $5.5 million and other assets of $0.9 million, partially offset by increases in accounts payable, accrued expenses and operating lease liabilities of $3.2 million and deferred revenue of $0.5 million. The non-cash operating expenses consisted of stock-based compensation expense of $22.5 million, a loss on an investment in a former related party of $0.2 million, amortization of right-of-use operating lease assets of $0.1 million and depreciation expense of $0.1 million, partially offset by accretion of discount on investment securities of $6.9 million.

Previous 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.

Current wording

For the six months ended June 30, 2025, net cash used in operating activities consisted of a net loss of $61.1 million, partially offset by a decrease in net operating assets and liabilities of $1.4 million and net non-cash operating expenses of $8.2 million. The decrease in net operating assets and liabilities was attributable to an increase in accounts payable, accrued expenses and operating lease liabilities of $1.6 million and decreases in a receivable from Zenas of $0.8 million and other assets of $0.5 million, partially offset by an increase in prepaid expenses and other current assets of $1.3 million and accounts receivable of $0.1 million and a decrease in deferred revenue of $0.1 million. The non-cash operating expenses consisted of stock-based compensation expense of $11.0 million and amortization of right-of-use operating lease assets of $0.2 million, partially offset by accretion of discount on investment securities of $3.0 million.

Previous 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.

Current wording

For the six months ended June 30, 2026, net cash used in investing activities consisted of $804.4 million of purchases of investment securities and $0.2 million of capital expenditures, partially offset by $192.1 million in proceeds from sales and maturities of investment securities.

Previous 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.

Current wording

For the six months ended June 30, 2025, net cash provided by investing activities consisted primarily of $141.7 million in proceeds from maturities of investment securities, partially offset by $100.4 million of purchases of investment securities.

Previous 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.

Current wording

For the six months ended June 30, 2026, net cash provided by financing activities consisted primarily of $676.1 million of net proceeds from a public offering, $58.7 million of proceeds from the ATM offering program, $14.9 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 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.

Current wording

For the six months ended June 30, 2025, net cash provided by financing activities consisted primarily of $0.6 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

We lease administrative office space under operating lease agreements in New York, New York, and Waltham, Massachusetts, which expire in February 2031 and January 2027, respectively.

Current wording

We lease administrative office space under operating lease agreements in New York, New York, and Waltham, Massachusetts, which expire in February 2031 and January 2027, respectively. In July 2026, we entered into an agreement to lease approximately 11,232 square feet of building space in Waltham, Massachusetts. The term of the lease agreement is approximately seven years commencing on September 15, 2026. The new lease agreement will replace our current lease agreement for office space in Waltham, Massachusetts, which is set to expire in January 2027.

Previous wording

In October 2025, we entered into a license agreement with Leads, pursuant to which Leads granted us a royalty-bearing, exclusive license outside Greater China to develop, manufacture, commercialize, or otherwise exploit DNTH212, a bifunctional fusion protein being developed in China by Leads as LBL-047. We also obtained certain non-exclusive rights to perform development and manufacturing activities in Greater China to support DNTH212 outside of Greater China. DNTH212 is an investigational, extended half-life bifunctional fusion protein targeting plasmacytoid dendritic cell BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function. We are obligated to pay Leads up to $38.0 million, comprised of $30.0 million in upfront and near-term milestone payments plus an additional $8.0 million milestone, payable in cash or our common stock at our election, upon the initiation of a Dianthus-led Phase 1 study, for exclusive rights to develop and commercialize DNTH212 globally outside of Greater China. As of March 31, 2026, we have paid Leads $30.0 million in upfront and near-term milestone payments. We are also obligated to pay up to $962.0 million in development and regulatory approval milestones across three key geographies and sales-based milestones across five indications, as well as tiered royalties from mid-single digits up to a low double-digit on ex-Greater China net sales.

Current wording

In October 2025, we entered into a license agreement with Leads, pursuant to which Leads granted us a royalty-bearing, exclusive license outside of Greater China to develop, manufacture, commercialize, or otherwise exploit DNTH212, a bifunctional fusion protein being developed in China by Leads as LBL-047. We also obtained certain non-exclusive rights to perform development and manufacturing activities in Greater China to support DNTH212 outside of Greater China. DNTH212 is an investigational, extended half-life bifunctional fusion protein targeting plasmacytoid dendritic cell BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function. We are obligated to pay Leads up to $38.0 million, comprised of $30.0 million in upfront and near-term milestone payments plus an additional $8.0 million milestone, payable in cash or our common stock at our election, upon the initiation of a Dianthus-led Phase 1 study, for exclusive rights to develop and commercialize DNTH212 globally outside of Greater China. As of June 30, 2026, we have paid Leads $30.0 million in upfront and near-term milestone payments. We are also obligated to pay up to $962.0 million in development and regulatory approval milestones across three key geographies and sales-based milestones across five indications, as well as tiered royalties from mid-single digits up to a low double-digit on ex-Greater China net sales.