Dianthus Therapeutics, Inc. /DE/

Previous wording

We are a clinical-stage biotechnology company focused on developing next-generation complement therapeutics for patients living with severe autoimmune and inflammatory diseases. We believe our lead novel and proprietary monoclonal antibody product candidate, claseprubart, formerly referred to as DNTH103, 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 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.

Previous wording

Our most advanced product candidate, claseprubart, formerly referred to as DNTH103, 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. 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”).

Previous wording

The MaGic trial is a global, randomized, double-blind, placebo-controlled Phase 2 study of claseprubart in up to 60 patients with gMG who are acetylcholine receptor antibody positive. Following an initial loading dose, claseprubart will be administered every two weeks (“Q2W”) via S.C. injection. The S.C. treatment duration will initially be 12 weeks with a 52-week open label extension. The primary endpoint of the study is safety and tolerability. Secondary endpoints include Myasthenia Gravis Activities of Daily Living Scale (“MG-ADL”) and Quantitative Myasthenia Gravis (“QMG”) score assessments. We announced the completion of enrollment of the MaGiC trial in May 2025 with 65 patients, exceeding our initial target of 60 patients, and top-line results are expected in September 2025.

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. 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

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 with a loading dose followed by 300mg claseprubart 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 half 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. 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.

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 administered Q2W via S.C. injection. The initial S.C. treatment duration is expected to be 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 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.

Previous wording

If our development efforts for claseprubart, or any future product candidates, if any, are successful and result in regulatory approval, we may generate revenue from future product sales. If we enter into license or collaboration agreements for claseprubart, or any future product candidates, if any, or intellectual property, revenue may be generated in the future from such license or collaboration agreements. We cannot predict if, when, or to what extent we will generate revenue from the commercialization and sale of claseprubart or any future product candidates or from license or collaboration agreements. We may never succeed in obtaining regulatory approval for claseprubart or any future product candidates.

Current wording

If our development efforts for claseprubart, DNTH212, or any other future product candidates, if any, are successful and result in regulatory approval, we may generate revenue from future product sales. If we enter into license or collaboration agreements for claseprubart, DNTH212, or any other future product candidates, if any, or intellectual property, revenue may be generated in the future from such license or collaboration agreements. We cannot predict if, when, or to what extent we will generate revenue from the commercialization and sale of claseprubart, DNTH212, or any other future product candidates or from license or collaboration agreements. We may never succeed in obtaining regulatory approval for claseprubart, DNTH212, or any other future product candidates.

Previous wording

In June 2022, we executed a license agreement with Zenas BioPharma, Inc. (formerly Zenas BioPharma Limited) (“Zenas”), formerly considered a related party, which provided Zenas with a license in the People’s Republic of China, including Hong Kong, Macau, and Taiwan (“Greater China”) for the development and commercialization of certain sequences and products under an identified antibody sequence (the “Zenas License Agreement”). The Zenas License Agreement included the following payments from Zenas: (i) a non-refundable upfront payment of $1.0 million; (ii) an approximately $1.1 million reimbursement payment for a portion of development costs previously incurred by us; (iii) reimbursement of a portion of all CMC-related costs and expenses for the first antibody sequence through the manufacture of the first two batches of drug product; (iv) reimbursement of a portion of all non-CMC-related costs and expenses for the development of the first antibody sequence through the first regulatory approval; (v) development milestones totaling up to $11.0 million; and (vi) royalties on net sales ranging from the mid-single digits to the low teen percentages.

Current wording

In June 2022, we executed a license agreement with Zenas BioPharma, Inc. (formerly Zenas BioPharma Limited) (“Zenas”), formerly considered a related party, which provided Zenas with a license in the People’s Republic of China, including Hong Kong, Macau, and Taiwan (“Greater China”) for the development and commercialization of certain sequences and products under an identified antibody sequence (the “Zenas License Agreement”). The Zenas License Agreement included the following payments from Zenas: (i) a non-refundable upfront payment of $1.0 million; (ii) an approximately $1.1 million reimbursement payment for a portion of development costs previously incurred by us; (iii) reimbursement of a portion of all chemistry, manufacturing and control (“CMC”) -related costs and expenses for the first antibody sequence through the manufacture of the first two batches of drug product; (iv) reimbursement of a portion of all non-CMC-related costs and expenses for the development of the first antibody sequence through the first regulatory approval; (v) development milestones totaling up to $11.0 million; and (vi) royalties on net sales ranging from the mid-single digits to the low teen percentages.

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 six months ended June 30, 2025, we recognized revenue of $1.0 million related to milestones achieved under the Tenacia Agreements (as defined below). We have not recorded any royalty revenue under the Zenas Agreement prior to novation or 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. 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.

Previous wording

We recognized related party license revenue totaling nil during each of the three and six months ended June 30, 2025, and $1.9 million and $2.7 million during the three and six months ended June 30, 2024, respectively, associated with the Zenas Agreements.

Current wording

We recognized related party license revenue totaling nil during each of the three and nine months ended September 30, 2025, and $2.2 million and $4.9 million during the three and nine months ended September 30, 2024, respectively, associated with the Zenas Agreements.

Previous wording

During the three and six months ended June 30, 2025, we recognized license revenue totaling $0.2 million and $1.4 million, respectively, related to the Tenacia Agreements.

Current 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.

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, 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, 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 or any future product candidates 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 or any future product candidates. To the extent claseprubart or any future product candidates continue to 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 or any 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, 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:

Previous wording

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

Current 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.

Previous wording

We expect that our general and administrative expenses will increase in the future to support our continued research and development activities, pre-commercial preparation activities for the product candidates and, if any product candidate receives marketing approval, commercialization activities. In addition, we anticipate that we will incur additional expenses associated with being a public company, including expenses related to accounting, audit, legal, regulatory, public company reporting and compliance, director and officer insurance, investor and public relations, and other administrative and professional services.

Current wording

We expect that our general and administrative expenses will increase in the future to support our continued research and development activities, pre-commercial preparation activities for the product candidates and, if any product candidate receives marketing approval, commercialization activities. In addition, we will continue to incur expenses associated with being a public company, including expenses related to accounting, audit, legal, regulatory, public company reporting and compliance, director and officer insurance, investor and public relations, and other administrative and professional services.

Previous wording

Other income/(expense) consists primarily of interest income generated from earnings on invested cash equivalents and investment securities.

Current wording

Other income/(expense) consists primarily of interest and investment income generated from earnings on invested cash and investment securities.

Previous wording

The following table summarizes our results of operations and other comprehensive loss for the periods indicated:

Current wording

The following table summarizes our results of operations for the periods indicated:

Previous wording

Under the terms of the Zenas Agreements, we recognized related party license revenue of nil and $1.9 million during the three months ended June 30, 2025 and 2024, respectively. Additionally, under the terms of the Tenacia Agreements, we recognized license revenue of $0.2 million and nil for the three months ended June 30, 2025 and 2024, respectively.

Current 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.

Previous wording

The decrease in total revenues was due to a decrease of $1.3 million in reimbursable costs associated with claseprubart’s ongoing clinical trials.

Current 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.

Previous wording

Research and development expenses were $26.3 million for the three months ended June 30, 2025, as compared to $18.1 million for the three months ended June 30, 2024, an increase of $8.2 million. This increase was due to: (1) a $4.8 million increase in external research and development costs, consisting of clinical operations activities, CMC activities, preclinical study costs, discovery expenses and other costs related to claseprubart; and (2) a $3.4 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 $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.

Previous wording

The $4.8 million increase in external research and development costs was due to a $5.1 million increase in expenses related to our lead product candidate, claseprubart, partially offset by a $0.3 million decrease in discovery activities. For the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, the increase in claseprubart related expense was due to $7.8 million in clinical operations activities and $0.4 million in CMC activities, partially offset by decreases of $2.6 million in preclinical study costs and $0.5 million in other costs related to claseprubart. The increased costs of clinical operations activities and CMC 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 $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.

Previous wording

General and administrative expenses were $8.9 million for the three months ended June 30, 2025, as compared to $6.0 million for the three months ended June 30, 2024, an increase of $2.9 million. The increase was primarily due to increases of $1.5 million in stock-based compensation expense, $0.8 million in personnel-related costs and $0.6 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

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.

Previous wording

Other income was $3.3 million for the three months ended June 30, 2025, as compared to $4.6 million for the three months ended June 30, 2024, a decrease of $1.3 million. The decrease was primarily due to higher cash and investment balances in the prior comparable period.

Current 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.

Previous wording

The following table summarizes our results of operations and other comprehensive loss for the periods indicated:

Current wording

The following table summarizes our results of operations for the periods indicated:

Previous wording

Under the terms of the Zenas Agreements, we recognized related party license revenue of nil and $2.7 million during the six months ended June 30, 2025 and 2024, respectively. Additionally, under the terms of the Tenacia Agreements, we recognized license revenue of $1.4 million and nil for the six months ended June 30, 2025 and 2024, respectively.

Current wording

Under the terms of the Zenas Agreements, we recognized related party license revenue of nil and $4.9 million during the nine months ended September 30, 2025 and 2024, respectively. Additionally, under the terms of the Tenacia Agreements, we recognized license revenue of $1.8 million and nil for the nine months ended September 30, 2025 and 2024, respectively.

Previous wording

The decrease in total revenues was due to a decrease of $1.7 million in reimbursable costs associated with claseprubart’s ongoing clinical trials.

Current wording

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

Previous wording

Research and development expenses were $53.3 million for the six months ended June 30, 2025, as compared to $31.2 million for the six months ended June 30, 2024, an increase of $22.1 million. This increase was due to: (1) a $14.6 million increase in external research and development costs, consisting of clinical operations activities, CMC activities, preclinical study costs, discovery expenses and other costs related to claseprubart; and (2) a $7.5 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 $85.7 million for the nine months ended September 30, 2025, as compared to $56.7 million for the nine months ended September 30, 2024, an increase of $29.0 million. This increase was due to: (1) a $18.5 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 $10.5 million increase in internal research and development costs, consisting of personnel and related costs, stock-based compensation expense and other costs.

Previous wording

The $14.6 million increase in external research and development costs was due to a $14.5 million increase in expenses related to our lead product candidate, claseprubart, and a $0.1 million increase in discovery activities. For the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, the increase in claseprubart related expense was due to increases of $16.3 million in clinical operations activities and $1.4 million in CMC activities, partially offset by decreases of $2.6 million in preclinical study costs and $0.5 million in other costs related to claseprubart. The increased costs of clinical operations activities and CMC 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 $18.5 million increase in external research and development costs was due to a $19.1 million increase in expenses related to our lead product candidate, claseprubart, partially offset by a $0.6 million decrease in discovery activities. For the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, the increase in claseprubart related expense was due to increases of $21.1 million in clinical operations activities, $0.8 million in CMC activities, and $1.5 million in licensing and milestone expenses, partially offset by a decrease of $4.3 million in preclinical study costs. The increased costs of clinical operations activities, CMC 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.

Previous wording

The $7.5 million increase in internal research and development costs was due to increases of $4.4 million in personnel and related costs, $2.7 million in stock-based compensation expense and $0.4 million in other expenses. 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 $10.5 million increase in internal research and development costs was due to increases of $6.3 million in personnel and related costs, $3.6 million in stock-based compensation expense and $0.6 million in other expenses. 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.

Previous wording

General and administrative expenses were $16.2 million for the six months ended June 30, 2025, as compared to $11.6 million for the six months ended June 30, 2024, an increase of $4.6 million. The increase was primarily due to increases of $3.1 million in stock-based compensation expense and $1.5 million in personnel-related 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

General and administrative expenses were $24.4 million for the nine months ended September 30, 2025, as compared to $18.2 million for the nine months ended September 30, 2024, an increase of $6.2 million. The increase was primarily due to increases of $4.2 million in stock-based compensation expense and $2.0 million in personnel-related costs. The increase in costs was primarily due to increases in headcount and related expenses.

Previous wording

Other income was $7.0 million for the six months ended June 30, 2025, as compared to $8.7 million for the six months ended June 30, 2024, a decrease of $1.7 million. The decrease was primarily due to higher cash and investment balances in the prior comparable period.

Current wording

Other income was $10.5 million for the nine months ended September 30, 2025, as compared to $13.4 million for the nine months ended September 30, 2024, a decrease of $2.9 million. The decrease was primarily due to higher cash and investment balances in the prior comparable 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, formerly referred to as DNTH103, or any 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 or any 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” 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.

Previous wording

We have an open market sales agreement with TD Securities (USA) LLC (“TD Cowen”) (the “ATM Agreement”) pursuant to which we may sell, from time to time through TD Cowen, 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. 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.

Previous wording

To date, we have funded our operations primarily through 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

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.

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 or any future product candidates, and we do not know when, or if, that will occur. In order to complete the development of claseprubart or any 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 cash flow from operating activitie…

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 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.

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 $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 $61.1 million and $31.4 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $235.5 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, 2025, we had cash, cash equivalents and investments of $309.1 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 the second half of 2027. 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

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.

Previous wording

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

Current wording

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

Previous 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.

Current 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.

Previous wording

For the six months ended June 30, 2024, net cash used in operating activities consisted of a net loss of $31.4 million and an increase in net operating assets and liabilities of $2.5 million, partially offset by net non-cash operating expenses of $4.4 million. The increase in net operating assets and liabilities was primarily attributable to increases in other assets of $1.5 million, unbilled receivable from Zenas of $0.6 million, receivable from Zenas of $0.5 million and prepaid expenses and other current assets of $0.1 million, partially offset by an increase in accounts payable, accrued expenses and operating lease liabilities of $0.2 million. The non-cash operating expenses consisted mainly of stock-based compensation expense of $5.1 million and amortization of right-of-use operating lease assets of $0.2 million, partially offset by accretion of discount on investment securities of $0.9 million.

Current 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.

Previous 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.

Current 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.

Previous wording

For the six months ended June 30, 2024, net cash used in investing activities consisted primarily of $27.3 million of purchases of investment securities, partially offset by $23.0 million of proceeds from maturities of investment securities.

Current 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.