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 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. By targeting two validated pathways with complementary disease-modifying mechanisms, DNTH312 expands Dianthus' leadership position in autoimmune diseases with its potential for best-in-disease efficacy by targeting deeper responses and broader symptom control, while also addressing larger patient populations.
DNTH312 is on track to be Phase 1 ready by YE'27.
Corporate Updates
Dianthus was selected by Great Place To Work® and Fortune magazine for the 2026 Fortune Best Workplaces in BioPharmaTM List. This was Dianthus' inaugural appearance on the list, ranking among the top 30 small- and medium-sized biotechnology and pharmaceutical companies in the United States. The Company was recognized for fostering a high-trust and engaging workplace culture.
Third-Quarter 2026 Financial Results
Cash Position – Approximately $1.2 billion of cash, cash equivalents and investments as of September 30, 2026, is projected to provide runway into 2030.
R&D Expenses – Research and development (R&D) expenses for the quarter ended September 30, 2026 were $45.6 million, inclusive of $6.3 million of stock-based compensation, compared to $32.5 million for the quarter ended September 30, 2025, which included $2.5 million of stock-based compensation. This increase in R&D expenses was primarily driven by higher clinical costs and increased headcount to support claseprubart Phase 2 and Phase 3 development, in addition to costs related to DNTH212 and DNTH312 development.
G&A Expenses – General and administrative (G&A) expenses for the quarter ended September 30, 2026 totaled $14.1 million, inclusive of stock-based compensation of $6.4 million, compared to $8.2 million for the quarter ended September 30, 2025, which included $3.3 million of stock-based compensation. This increase in G&A expenses was primarily due to increased headcount.
Net Loss – Net loss for the quarter ended September 30, 2026 was $46.6 million or $0.81 per share (basic and diluted), compared to $36.8 million or $0.97 per share (basic and diluted) for the quarter ended September 30, 2025.
Additional Information – For additional information on the Company's financial results for the quarter ended September 30, 2026, please refer to the Form 10-Q filed with the SEC.
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 results from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy in December '26, report top-line results from the Phase 3 CAPTIVATE trial Part A in CIDP by YE'27 and from Part B by YE'28, and 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 SLE (Part B) is ongoing, with preliminary healthy volunteer data expected in Q1'27 and preliminary Part B SLE data expected in 2H'27. Dianthus plans to initiate a Phase 1 multiple ascending dose (MAD) study outside of China in healthy volunteers in Q2'27 to support the continued global development of DNTH212, with preliminary data expected in 2H'27. Dianthus plans to provide an update on next steps for advancing its first three prioritized indications in clinical development by YE'27.
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 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 is on track 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 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 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
...
DIANTHUS THERAPEUTICS, INC.
| |
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
(unaudited)
| |
| | September 30,
2026 | | | December 31,
2025 | |
| Assets | | | | | | |
| Current assets: | | | | | | |
| Cash and cash equivalents | | $ | 55,686 | | | $ | 51,087 | |
| Short-term investments | | | 782,097 | | | | 353,208 | |
| Accounts receivable, net | | | 582 | | | | 52 | |
| Prepaid expenses and other current assets | | | 17,673 | | | | 5,091 | |
| Total current assets | | | 856,038 | | | | 409,438 | |
| Long-term investments | | | 406,040 | | | | 110,135 | |
| Property and equipment, net | | | 749 | | | | 296 | |
| Right-of-use operating lease assets | | | 1,151 | | | | 1,337 | |
| Other assets and restricted cash | | | 12,274 | | | | 9,716 | |
| Total assets | | $ | 1,276,252 | | | $ | 530,922 | |
| Liabilities and Stockholders' Equity | | | | | | |
| Current liabilities: | | | | | | |
| Accounts payable | | $ | 5,498 | | | $ | 9,725 | |
| Accrued expenses | | | 21,079 | | | | 19,452 | |
| Current portion of deferred revenue | | | 1,589 | | | | 1,188 | |
| Current portion of operating lease liabilities | | | 349 | | | | 367 | |
| Total current liabilities | | | 28,515 | | | | 30,732 | |
| Deferred revenue | | | 5,449 | | | | 5,770 | |
| Long-term operating lease liabilities | | | 859 | | | | 1,019 | |
| Total liabilities | | | 34,823 | | | | 37,521 | |
| Commitments and contingencies | | | | | | |
| Stockholders' equity: | | | | | | |
| Preferred stock | | | - | | | | - | |
| Common stock | | | 56 | | | | 43 | |
| Additional paid-in capital | | | 1,722,069 | | | | 829,598 | |
| Accumulated deficit | | | (474,421 | ) | | | (336,729 | ) |
| Accumulated other comprehensive (loss)/income | | | (6,275 | ) | | | 489 | |
| Total stockholders' equity | | | 1,241,429 | | | | 493,401 | |
| Total liabilities and stockholders' equity | | $ | 1,276,252 | | | $ | 530,922 | |
DIANTHUS THERAPEUTICS, INC.
| |
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
| |
| | Three Months Ended
September 30, | | | Nine Months Ended
September 30, | |
| | 2026 | | | 2025 | | | 2026 | | | 2025 | |
| Revenues: | | | | | | | | | | | | |
| License revenue | | $ | 1,210 | | | $ | 396 | | | $ | 2,434 | | | $ | 1,752 | |
| Operating expenses: | | | | | | | | | | | | |
| Research and development | | | 45,600 | | | | 32,489 | | | | 128,814 | | | | 85,743 | |
| General and administrative | | | 14,082 | | | | 8,195 | | | | 40,107 | | | | 24,401 | |
| Total operating expenses | | | 59,682 | | | | 40,684 | | | | 168,921 | | | | 110,144 | |
| Loss from operations | | | (58,472 | ) | | | (40,288 | ) | | | (166,487 | ) | | | (108,392 | ) |
| Other income/(expense): | | | | | | | | | | | | |
| Interest and investment income | | | 12,143 | | | | 3,658 | | | | 29,950 | | | | 10,852 | |
| Gain/(loss) on investment in former related party | | | 28 | | | | 227 | | | | (169 | ) | | | 254 | |
| Loss on currency exchange, net | | | (24 | ) | | | (2 | ) | | | (49 | ) | | | (54 | ) |
| Other expense | | | (318 | ) | | | (360 | ) | | | (937 | ) | | | (565 | ) |
| Total other income | | | 11,829 | | | | 3,523 | | | | 28,795 | | | | 10,487 | |
| Net loss | | $ | (46,643 | ) | | $ | (36,765 | ) | | $ | (137,692 | ) | | $ | (97,905 | ) |
| Net loss per share attributable to common stockholders, basic and diluted | | $ | (0.81 | ) | | $ | (0.97 | ) | | $ | (2.56 | ) | | $ | (2.68 | ) |
| 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 | | | 57,341,193 | | | | 37,794,088 | | | | 53,835,116 | | | | 36,476,370 | |
| Comprehensive loss: | | | | | | | | | | | | |
| Net loss | | $ | (46,643 | ) | | $ | (36,765 | ) | | $ | (137,692 | ) | | $ | (97,905 | ) |
| Other comprehensive (loss)/income: | | | | | | | | | | | | |
| Unrealized (loss)/gain on marketable securities | | | (4,147 | ) | | | 65 | | | | (6,764 | ) | | | 57 | |
| Total other comprehensive (loss)/income | | | (4,147 | ) | | | 65 | | | | (6,764 | ) | | | 57 | |
| Total comprehensive loss | | $ | (50,790 | ) | | $ | (36,700 | ) | | $ | (144,456 | ) | | $ | (97,848 | ) |
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