Dianthus Therapeutics, Inc 8-K, filed Aug 4, 2026
Dianthus Therapeutics, Inc. /DE/ (DNTH)
About this 8-K
Dianthus Therapeutics, Inc filed this 8-K on August 4, 2026.
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 4, 2026, Dianthus Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended June 30, 2026. A copy of this press release is furnished as Exhibit 99.1 and is incorporated herein by reference.
The information in this Form 8-K (including Exhibit 99.1 attached hereto) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing by the Company, under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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DIANTHUS THERAPEUTICS, INC. |
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Date: |
August 4, 2026 |
By: |
/s/ Adam M. Veness, Esq. |
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Adam M. Veness, Esq. |
Exhibit 99.1
DIANTHUS THERAPEUTICS HIGHLIGHTS RECENT BUSINESS ACHIEVEMENTS
AND REPORTS Q2 2026 FINANCIAL RESULTS
Advancing a neuromuscular franchise with claseprubart, a highly potent investigational classical pathway inhibitor, with best-in-disease potential across generalized Myasthenia Gravis (gMG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), and Multifocal Motor Neuropathy (MMN)
Phase 3 EMERGE registrational trial of claseprubart in gMG evaluating 300mg/2mL Q2W and 300mg/2mL Q4W initiated in June ‘26, with top-line results anticipated in 2H’28
75% response rate observed in Interim Responder Analysis from first 40 participants completing Part A of Phase 3 CAPTIVATE trial of claseprubart in CIDP, with Part B top-line guidance expected by YE’26
Phase 2 MoMeNtum trial of claseprubart in MMN exceeded its original enrollment target of 36 patients; top-line results with 46 patients on track for December ’26
Building a rheumatology franchise with DNTH212 across our first three prioritized indications of Sjögren’s Disease (SjD), Systemic Lupus Erythematosus (SLE), and Dermatomyositis (DM);
Phase 1 healthy volunteer data anticipated by YE’26
Advancing DNTH312, an internally developed, first-in-class, next-generation bifunctional fusion protein combining claseprubart and TACI to target potent inhibition of aC1s and BAFF/APRIL for severe autoimmune diseases; DNTH312 aims to be Phase 1 ready by YE’27
Approximately $1.2 billion of cash as of June 30, 2026 provides expected runway into 2030
New York City and Waltham, Mass., August 4, 2026 – Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases, today reported financial results for the second quarter ending June 30, 2026, and provided an update on other recent business achievements.
“Our strong execution in the first half of 2026 reflects the continued focus and discipline of the Dianthus team as we advance both claseprubart and DNTH212 for severe autoimmune diseases,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “With the initiation of our Phase 3 EMERGE registrational trial in gMG, excellent interim results from Part A of our Phase 3 CAPTIVATE trial in CIDP, and completion of enrollment in the Phase 2 MoMeNtum trial in MMN with top-line results expected in December, claseprubart continues to demonstrate its potential as a best-in-disease, pipeline-in-a-product opportunity. In addition, we anticipate Phase 1 healthy volunteer data for DNTH212 by year end. We continue to strengthen our leadership position in autoimmune diseases with today’s announcement of the addition of our innovative, internally
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www.dianthustx.com 7 Times Square, Floor 43 New York, NY 10036
developed, first-in-class, next generation, highly potent and half-life extended bifunctional fusion protein, DNTH312.”
Claseprubart: Potential Best-in-Disease aC1s Inhibitor for Neuromuscular Diseases
Claseprubart is an investigational, clinical-stage, potent monoclonal antibody engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein, a clinically validated complement target. Claseprubart is designed to enable a more convenient, subcutaneous (S.C.), self-administered injection dosed as infrequently as once every two or four weeks. Claseprubart has the potential to be a best-in-disease pipeline-in-a-product across a range of autoimmune disorders with high unmet need.
Generalized Myasthenia Gravis (gMG)
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Multifocal Motor Neuropathy (MMN)
All Programs
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www.dianthustx.com 7 Times Square, Floor 43 New York, NY 10036
DNTH212: Potential Best-in-Disease, Bifunctional BDCA2 and BAFF/APRIL Inhibitor for Rheumatology Conditions
DNTH212 is an investigational, extended half-life bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function. By targeting both the innate and adaptive immune systems via two clinically validated pathways that are known drivers of autoimmune disease pathogenesis, this complementary and differentiated approach has the potential to address multiple autoimmune indications with improved outcomes.
DNTH312: An Internally Developed, First-in-class, Next-generation Bifunctional Fusion Protein Combining Claseprubart and TACI to Target Potent Inhibition of aC1s and BAFF/APRIL for Autoimmune Diseases
Second-Quarter 2026 Financial Results
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www.dianthustx.com 7 Times Square, Floor 43 New York, NY 10036
About Claseprubart (DNTH103)
Claseprubart is an investigational, clinical-stage, potent monoclonal antibody engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein, a clinically validated complement target. Claseprubart is enhanced with YTE half-life extension technology designed to enable a more convenient subcutaneous, infrequently dosed, self-administered injection. Additionally, selective inhibition of the classical complement pathway may lower patient risk of infection from encapsulated bacteria by preserving immune activity of the lectin and alternative pathways. As the classical pathway plays a significant role in disease pathology, claseprubart has the potential to be a best-in-disease pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Claseprubart was granted Orphan Drug Designation by the FDA for the treatment of Myasthenia Gravis in May 2026.
Dianthus is building a neuromuscular franchise with claseprubart and expects to report top-line data from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy in December ’26, to provide an update on timing of top-line data from Part B of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy by YE’26, and to report top-line results from the Phase 3 EMERGE trial in generalized Myasthenia Gravis in 2H’28.
Claseprubart is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide.
About DNTH212
DNTH212 is an investigational, extended half-life bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function. By targeting both the innate and adaptive immune systems via two clinically validated pathways that are known drivers of autoimmune disease pathogenesis, this complementary and differentiated approach has the potential to address multiple autoimmune indications with improved outcomes. Dianthus is building a rheumatology franchise with DNTH212 and has selected Sjögren’s Disease (SjD), Systemic Lupus Erythematosus (SLE), and Dermatomyositis (DM) as the first three prioritized indications for clinical development. A two-part Phase 1 study in China in healthy volunteers (Part A) and patients with systemic lupus erythematosus (Part B) is ongoing, with healthy volunteer data expected by YE’26.
DNTH212 is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide.
About DNTH312
DNTH312 is an internally developed, investigational, first-in-class, next-generation bifunctional fusion protein combining claseprubart and TACI to target potent inhibition of aC1s and BAFF/APRIL. DNTH312 is enhanced
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www.dianthustx.com 7 Times Square, Floor 43 New York, NY 10036
with YTE half-life extension technology, similar to claseprubart. By targeting two validated pathways with complementary disease modifying mechanisms, DNTH312 is designed to expand Dianthus’ leadership position in autoimmune diseases with potential for best-in-disease efficacy by targeting deeper responses and broader symptom control, while also addressing larger patient populations. DNTH312 aims to be Phase 1 ready by YE’27.
DNTH312 is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide.
About Dianthus Therapeutics
Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who aim to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases.
To learn more, please visit www.dianthustx.com and follow us on LinkedIn.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995, express or implied statements regarding future plans and prospects, including statements regarding the expectations or plans for discovery, preclinical studies, clinical trials and research and development programs, in particular with respect to claseprubart, DNTH212, and DNTH312, and any developments or results in connection therewith, including the target product profile and administration of claseprubart, DNTH212, and DNTH312; the anticipated timing of the initiation and results from those studies and trials; expectations regarding the clinical trial designs or indications; expectations regarding the time period over which the Company’s capital resources are expected to be sufficient to fund its anticipated operations; and expectations regarding market size, patient population size, and potential market opportunities, in particular with respect to claseprubart, DNTH212 and DNTH312. Claseprubart, DNTH212, and DNTH312 are investigational agents that are not approved as therapies in any indication in any jurisdiction worldwide. The words “opportunity,” “potential,” “milestones,” “runway,” “will,” “anticipate,” “achieve,” “near-term,” “catalysts,” “pursue,” “pipeline,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit,” and similar expressions (including the negatives of these terms or variations of them) generally identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking.
Actual results could differ materially from those included in the forward-looking statements due to various factors, risks and uncertainties, including, but not limited to, that preclinical testing of claseprubart, DNTH212, and DNTH312 and data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that the preliminary interim analysis based on a limited number of patients from the Part A open label portion of the claseprubart CAPTIVATE study in patients with CIDP may not be predictive of the results or success of the remaining patients treated in Part A or patients treated in Part B of the CAPTIVATE study, that the development of claseprubart, DNTH212, or DNTH312 may take longer and/or cost more than planned, that the Company or its partner may be unable to successfully complete the clinical development of the Company’s compounds, that the Company or its partner may be delayed in initiating, enrolling or completing its planned clinical trials, and that the Company's compounds may not receive regulatory approval or become commercially
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successful products. These and other risks and uncertainties are identified under the heading "Risk Factors" included in the Company’s Annual Report on Form 10-K for the period ended December 31, 2025, and other filings that the Company has made and may make with the SEC in the future. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved.
The forward-looking statements in this press release speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Dianthus undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
Contact
Jennifer Davis Ruff
Dianthus Therapeutics
jdavisruff@dianthustx.com
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www.dianthustx.com 7 Times Square, Floor 43 New York, NY 10036
DIANTHUS THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
(unaudited)
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June 30, |
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December 31, |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
110,549 |
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$ |
51,087 |
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Short-term investments |
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776,264 |
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353,208 |
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Accounts receivable, net |
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106 |
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52 |
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Prepaid expenses and other current assets |
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10,618 |
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5,091 |
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Total current assets |
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897,537 |
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409,438 |
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Long-term investments |
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303,633 |
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110,135 |
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Property and equipment, net |
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418 |
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296 |
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Right-of-use operating lease assets |
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1,223 |
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1,337 |
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Other assets and restricted cash |
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10,460 |
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9,716 |
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Total assets |
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$ |
1,213,271 |
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$ |
530,922 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
6,390 |
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$ |
9,725 |
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Accrued expenses |
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26,101 |
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19,452 |
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Current portion of deferred revenue |
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1,524 |
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1,188 |
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Current portion of operating lease liabilities |
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374 |
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367 |
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Total current liabilities |
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34,389 |
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30,732 |
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Deferred revenue |
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5,944 |
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5,770 |
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Long-term operating lease liabilities |
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913 |
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1,019 |
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Total liabilities |
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41,246 |
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37,521 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Preferred stock |
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— |
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— |
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Common stock |
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55 |
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43 |
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Additional paid-in capital |
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1,601,876 |
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829,598 |
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Accumulated deficit |
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(427,778 |
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(336,729 |
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Accumulated other comprehensive (loss)/income |
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(2,128 |
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489 |
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Total stockholders’ equity |
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1,172,025 |
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493,401 |
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Total liabilities and stockholders’ equity |
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$ |
1,213,271 |
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$ |
530,922 |
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www.dianthustx.com 7 Times Square, Floor 43 New York, NY 10036
DIANTHUS THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended |
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Six Months Ended |
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2026 |
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2025 |
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2026 |
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2025 |
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Revenues: |
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License revenue |
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$ |
761 |
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$ |
193 |
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$ |
1,224 |
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$ |
1,356 |
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Operating expenses: |
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Research and development |
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48,686 |
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26,251 |
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83,214 |
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53,254 |
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General and administrative |
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13,557 |
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8,869 |
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26,025 |
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16,206 |
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Total operating expenses |
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62,243 |
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35,120 |
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109,239 |
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69,460 |
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Loss from operations |
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(61,482 |
) |
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(34,927 |
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(108,015 |
) |
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(68,104 |
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Other income/(expense): |
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Interest and investment income |
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11,542 |
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3,403 |
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17,807 |
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7,194 |
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Gain/(loss) on investment in former related party |
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105 |
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32 |
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(197 |
) |
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27 |
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Loss on currency exchange, net |
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(10 |
) |
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(30 |
) |
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(25 |
) |
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(52 |
) |
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Other expense |
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(370 |
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(107 |
) |
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(619 |
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(205 |
) |
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Total other income |
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11,267 |
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3,298 |
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16,966 |
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6,964 |
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Net loss |
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$ |
(50,215 |
) |
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$ |
(31,629 |
) |
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$ |
(91,049 |
) |
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$ |
(61,140 |
) |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.90 |
) |
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$ |
(0.88 |
) |
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$ |
(1.75 |
) |
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$ |
(1.71 |
) |
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Weighted-average number of shares of common stock outstanding including shares issuable under equity-classified pre-funded warrants, used in computing net loss per share of common stock, basic and diluted |
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56,029,124 |
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35,822,308 |
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52,053,022 |
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35,806,591 |
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Comprehensive loss: |
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Net loss |
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$ |
(50,215 |
) |
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$ |
(31,629 |
) |
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$ |
(91,049 |
) |
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$ |
(61,140 |
) |
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Other comprehensive loss: |
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Unrealized loss on marketable securities |
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(1,553 |
) |
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(172 |
) |
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(2,617 |
) |
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(8 |
) |
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Total other comprehensive loss |
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(1,553 |
) |
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(172 |
) |
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(2,617 |
) |
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(8 |
) |
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Total comprehensive loss |
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$ |
(51,768 |
) |
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$ |
(31,801 |
) |
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$ |
(93,666 |
) |
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$ |
(61,148 |
) |
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www.dianthustx.com 7 Times Square, Floor 43 New York, NY 10036