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Dianthus Therapeutics Highlights Recent Business Achievements and Reports Q3 Financial Results

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Dianthus Therapeutics (Nasdaq: DNTH) reported Q3 2025 results and business updates highlighting positive clinical progress for claseprubart (DNTH103), the in-licensing of DNTH212, and a strengthened cash position. Key clinical developments include statistically significant Phase 2 MaGic gMG results at Week 13, AANEM data supporting potential 300mg/2mL Q4W dosing, planned Phase 3 gMG initiation in 2026 with two dose arms, accelerated CIDP Phase 3 interim responder analysis to Q2 2026, and ongoing MMN Phase 2 with top-line in 2H’26. Financial highlights: estimated adjusted cash of ~$525M (runway into 2028), R&D of $32.5M in Q3, and net loss of $36.8M (Q3 2025).

Dianthus Therapeutics (Nasdaq: DNTH) ha riportato i risultati del terzo trimestre 2025 e aggiornamenti aziendali che evidenziano progressi clinici positivi per claseprubart (DNTH103), l'acquisizione in licenza di DNTH212, e una posizione di cassa rafforzata. Sviluppi clinici chiave includono risultati statisticamente significativi di fase 2 MaGic gMG a settimana 13, dati AANEM che supportano una potenziale dosazione di 300 mg/2 mL ogni 4 settimane, l'inizio pianificato di una fase 3 gMG nel 2026 con due bracci di dosaggio, un'analisi provvisoria accelerata di risposta della fase 3 CIDP entro il Q2 2026, e una fase 2 continua MMN con top-line atteso nella seconda metà del 2026. Evidenze finanziarie: cassa aggiustata stimata di ~$525M (runway fino al 2028), R&D di $32.5M nel Q3, e perdita netta di $36.8M (Q3 2025).

Dianthus Therapeutics (Nasdaq: DNTH) informó resultados del tercer trimestre de 2025 y actualizaciones de negocio que destacan avances clínicos positivos para claseprubart (DNTH103), la licencia de DNTH212 y una posición de efectivo fortalecida. Los desarrollos clínicos clave incluyen resultados estadísticamente significativos de la Fase 2 MaGic gMG en la Semana 13, datos de AANEM que respaldan una dosis potencial de 300 mg/2 mL cada 4 semanas, inicio planificado de una Fase 3 gMG en 2026 con dos brazos de dosis, análisis interino acelerado de respuesta de la Fase 3 CIDP para 2T 2026, y una Fase 2 en curso de MMN con datos principales esperados en la 2ª mitad de 2026. Aspectos financieros: caja ajustada estimada de ~$525M (margen hasta 2028), I+D de $32.5M en el Q3 y pérdida neta de $36.8M (Q3 2025).

Dianthus Therapeutics (나스닥: DNTH)는 2025년 3분기 실적 및 사업 업데이트를 발표했으며 claseprubart (DNTH103)의 긍정적 임상 진행, DNTH212의 도입 계약 체결, 강화된 현금 보유를 강조했습니다. 주요 임상 개발은 13주 차에 통계적으로 유의한 2상 MaGic gMG 결과, 300mg/2mL Q4W 용량을 뒷받침하는 AANEM 데이터, 2026년 제3상 gMG 개시 계획(두 용량군 포함), 2026년 2분기 CIDP 제3상 중간 반응자 분석의 가속화, 그리고 2026년 하반기 상향 결정 예상인 MMN 2상 현황 및 상위 라인 발표를 포함합니다. 재무 하이라이트로는 ~$525M의 조정 현금 보유(2028년까지의 런웨이), 3분기에 $32.5M의 연구개발(R&D), 그리고 $36.8M의 순손실(Q3 2025)입니다.

Dianthus Therapeutics (Nasdaq : DNTH) a publié les résultats du T3 2025 et des mises à jour opérationnelles soulignant des progrès cliniques positifs pour claseprubart (DNTH103), le licensing de DNTH212 et une position de trésorerie renforcée. Les développements cliniques clés incluent des résultats statistiquement significatifs de la phase 2 MaGic gMG à la semaine 13, des données AANEM soutenant une posologie potentielle de 300 mg/2 mL toutes les 4 semaines, le démarrage prévu d’un gMG de phase 3 en 2026 avec deux bras de dose, une analyse intérimaire accélérée de répondeurs de la phase 3 CIDP pour le second trimestre 2026, et une MMN phase 2 en cours avec des résultats principaux attendus au second semestre 2026. Points financiers : trésorerie ajustée estimée d’environ $525M (piste jusqu’en 2028), R&D de $32.5M au T3 et perte nette de $36.8M (T3 2025).

Dianthus Therapeutics (Nasdaq: DNTH) meldete Ergebnisse des dritten Quartals 2025 und Unternehmensupdates, die positive klinische Fortschritte für claseprubart (DNTH103), die Lizenzierung von DNTH212 und eine gestärkte Cash-Position hervorheben. Zu den wichtigsten klinischen Entwicklungen gehören statistisch signifikante Phase-2-MaGic gMG Ergebnisse in Woche 13, AANEM-Daten, die eine potenzielle Dosierung von 300 mg/2 mL alle 4 Wochen unterstützen, der geplante Beginn einer Phase-3 gMG im Jahr 2026 mit zwei Dosierungsarmen, eine beschleunigte Zwischenanalyse der Reponser in der Phase-3-CIDP bis Q2 2026 und eine laufende MMN-Phase-2 mit Topline-Daten in der zweiten Hälfte von 2026. Finanzkennzahlen: geschätzte bereinigte Cash-Bestände von ca. $525M (Laufzeit bis 2028), F&E von $32.5M im Q3 und Nettoverlust von $36.8M (Q3 2025).

Dianthus Therapeutics (ناسداك: DNTH) ذكرت نتائج الربع الثالث من 2025 وتحديثات أعمال تبرز تقدمًا سريريًا إيجابيًا لـ claseprubart (DNTH103)، وتوقيع اتفاق ترخيص لـ DNTH212، وتحسين مركزها النقدي. التطورات السريرية الرئيسية تشمل نتائج المرحلة 2 MaGic gMG ذات دلالة إحصائية في الأسبوع 13، بيانات AANEM تدعم جرعة محتملة 300 ملغ/2 مل كل 4 أسابيع، والبدء المخطط لمرحلة 3 gMG في 2026 مع ذراعين للجرعة، وتحليل استجابة وسيط مبكر لمرحلة 3 CIDP إلى الربع الثاني من 2026، واستمرار المرحلة 2 MMN مع بيانات رئيسة في النصف الثاني من 2026. الإنجازات المالية: نقد مُعدل يقدر بنحو $525M (خط انتهاء حتى 2028)، وR&D بمقدار $32.5M في Q3، وخسارة صافية قدرها $36.8M (Q3 2025).

Positive
  • $525M estimated adjusted cash providing runway into 2028
  • Phase 2 gMG MaGic: statistically significant MG-ADL and QMG at Week 13
  • Phase 3 gMG planned for 2026 with dual 300mg/2mL Q2W and Q4W arms
  • CIDP CAPTIVATE interim responder analysis accelerated to Q2’26
  • Exclusive license of DNTH212 with expected Phase 1 healthy volunteer data in 2H’26
Negative
  • Net loss increased to $36.8M in Q3 2025 vs $25.2M year-ago quarter
  • R&D expenses rose to $32.5M in Q3 2025 reflecting higher clinical costs
  • $30M of upfront/near-term milestone payments reduce reported cash by that amount

Insights

Positive Phase 2 efficacy, faster Phase 3/CIDP timelines, a new in-licensed asset, and a healthy cash runway into 2028.

Claseprubart showed statistically significant, clinically meaningful improvements in MG-ADL and QMG at Week 13, with supportive OLE and in vitro data that justify testing both 300mg/2mL Q2W and 300mg/2mL Q4W in Phase 3. The company plans an end-of-Phase 2 meeting with the FDA and expects a Phase 3 start in 2026, which aligns mechanism, dose exploration, and regulatory engagement in a clear clinical path.

The CIDP Phase 3 trial interim responder analysis moved earlier to Q2'26 due to faster enrollment, and the MMN Phase 2 top-line readout remains on track for 2H'26. Those accelerated timelines materially increase near-term binary readouts that can change program valuation. Risks remain tied to confirmatory Phase 3 outcomes, which are not yet reported, and to reliance on the specified QMG ≥10 screening criterion for primary analysis.

Corporate and financials: the company closed a public offering (~$288 million gross) and announced an exclusive license for DNTH212, with Phase 1 healthy volunteer data expected in 2H'26. Management states an estimated $525 million of adjusted cash post-payments (derived from $555.5 million less $30 million), providing runway into 2028. Recent quarterly spend: R&D $32.5 million, G&A $8.2 million, and net loss $36.8 million ($0.97 per share).

Watch items and horizon: the pivotal Phase 3 initiation in 2026, the CIDP interim in Q2'26, MMN top-line in 2H'26, and Phase 1 readout for DNTH212 in 2H'26. These milestones, if positive, would be the main drivers of program de-risking over the next 12–24 months.

Claseprubart achieved statistically significant and clinically meaningful improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL), Quantitative Myasthenia Gravis (QMG), and other efficacy measures at Week 13 in Phase 2 MaGic trial in gMG

New claseprubart data from the MaGic open-label extension supporting potential for 300mg/2mL Q4W dosing and new in vitro data highlighting potential efficacy benefits of upstream (aC1s, claseprubart) vs. downstream (C5, ravulizumab) complement inhibition were presented during the AANEM Annual Meeting in October 2025

Phase 3 gMG trial including two claseprubart treatment arms, 300mg/2mL Q2W and 300mg/2mL Q4W, vs. placebo anticipated to initiate in 2026

Accelerated timing for interim responder analysis for Phase 3 CAPTIVATE trial of claseprubart in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); now anticipated in Q2’26 (formerly 2H’26) due to faster than expected enrollment

Phase 2 MoMeNtum trial of claseprubart in Multifocal Motor Neuropathy (MMN) ongoing; top-line results anticipated in 2H’26

Announced exclusive license agreement for DNTH212, a bifunctional BDCA2 and BAFF/APRIL inhibitor; Phase 1 healthy volunteer data anticipated in 2H’26

Estimated ~$525 million of cash after DNTH212 upfront and near-term milestone payments provides runway into 2028

NEW YORK and WALTHAM, Mass., Nov. 05, 2025 (GLOBE NEWSWIRE) -- 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 third quarter ending September 30, 2025, and provided an update on recent business achievements.

“I’m extremely proud of our team’s outstanding track record of execution against our vision to become a leading biotech company in the I&I field. Just in the past 2 months, we delivered impressive results from the gMG MaGic trial, accelerated the timing of the interim responder analysis from our CIDP CAPTIVATE trial from 2H’26 to Q2'26, and in-licensed DNTH212, a new and exciting clinical-stage bifunctional fusion protein. Both claseprubart and DNTH212 have validated mechanisms of action with pipeline-in-a-product potential, and aim to deliver best-in-class efficacy, safety, and convenience with infrequent, subcutaneous self-administration,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “The claseprubart efficacy and safety data from the MaGic trial, including the recently presented data for placebo patients transitioning to claseprubart in the OLE and the post-hoc analyses highlighting the impact of QMG screening criteria on MG-ADL results, strongly support our Phase 3 plans to advance both 300mg/2mL Q2W and 300mg/2mL Q4W as a potential best-in-class treatment option in gMG. We remain focused on execution as we aim to deliver first-line biologic therapies that can meaningfully improve the lives of patients with severe autoimmune diseases.”

Claseprubart (DNTH103) Clinical Development

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, self-administered injection dosed as infrequently as once every two or four weeks. Claseprubart has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need.

Generalized Myasthenia Gravis (gMG)

  • Positive Phase 2 data reported in September and presented at AANEM: Results from the MaGic trial, a global, randomized, double-blind, placebo-controlled Phase 2 trial in patients with gMG who are acetylcholine receptor (AChR) antibody positive, were reported in September and presented at the American Association of Neuromuscular and Electromagnetic Medicine (AANEM) Annual Meeting. Claseprubart 300mg/2mL and 600mg/4mL Q2W demonstrated rapid, statistically significant and clinically meaningful improvements over placebo as measured by both MG-ADL and QMG, including at Week 1 and at Week 13. The claseprubart 300mg/2mL Q2W dose was also statistically significant and clinically meaningful across other key efficacy endpoints, including Minimal Symptom Expression (MSE), Myasthenia Gravis Composite (MGC) Score and the Myasthenia Gravis Quality of Life Scale (MG-QoL-15r). Claseprubart was generally well tolerated with no drug-related Serious Adverse Events (SAEs) or discontinuations due to any related adverse event.

  • New MaGic data presented during AANEM: New claseprubart data were presented during AANEM and in a Virtual Industry Forum titled Upstream Targeting: Rethinking MG Treatment Through Active C1s Inhibition, which included:
    • A robust MG-ADL decline at week 4 in the open-label extension (OLE) of -2.5 points and QMG score reduction of -3.2 points for patients on placebo during the RCT who received only two doses of claseprubart 600mg/4mL Q2W without a loading dose and achieved a PK level far below the steady state of 300mg/2mL Q2W, supporting potential for Q4W dosing of 300mg/2mL
    • A subgroup analysis of patients enrolled in the MaGic trial with a QMG score ≥10 at baseline which demonstrated a 3-point difference from placebo in MG-ADL treatment effect for 300mg/2mL Q2W
    • In vitro data demonstrating the benefits of upstream (active C1s with claseprubart) vs. downstream (C5 with ravulizumab) inhibition in the prevention of pro-inflammatory split products C3a and C3b
  • Phase 3 trial expected to begin in 2026: An end-of-Phase 2 meeting is planned with the FDA to align on the proposed design of a Phase 3 trial for claseprubart in gMG that investigates both 300mg/2mL Q2W and 300mg/2mL Q4W doses vs. placebo and includes QMG ≥10 screening criteria.

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

  • Phase 3 CAPTIVATE CIDP trial interim responder analysis now expected in Q2’26: The CAPTIVATE trial is a single, global, two-part, randomized withdrawal Phase 3 trial in patients with CIDP, and an interim responder analysis (n=40) from Part A of this trial is now expected in Q2’26, accelerated from previous guidance of 2H’26 due to faster than expected enrollment. The Company believes this single pivotal trial will support a BLA filing in adult patients with CIDP.

Multifocal Motor Neuropathy (MMN)

  • Phase 2 MoMeNtum MMN trial remains on track for top-line results in 2H’26: The MoMeNtum trial is an ongoing global, randomized, double-blind, placebo-controlled Phase 2 trial in patients with MMN.

DNTH212 Clinical Development

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.

  • Phase 1 data anticipated in 2H’26: A two-part Phase 1 study in China in healthy volunteers (Part A) and patients with systemic lupus erythematosus (Part B) is expected to initiate by year-end 2025, with top-line results in healthy volunteers expected in the second half of 2026. An update on indication prioritization for DNTH212 is planned for 2026.

Corporate Updates

  • On September 11, Dianthus announced the closing of an upsized underwritten public offering of common stock, with aggregate gross proceeds of approximately $288 million.

  • On October 16, Dianthus entered into an exclusive licensing agreement with Nanjing Leads Biolabs Co., Ltd. (“Leads” (9887.HK)) for DNTH212 (being developed in China by Leads Biolabs as LBL-047), a first and potentially best-in-class bifunctional BDCA2 and BAFF/APRIL inhibitor.

Third-Quarter 2025 Financial Results

  • Cash Position – An estimated $525 million of adjusted cash, cash equivalents and investments as of September 30, 2025 is projected to provide runway into 2028. This $525 million estimate includes cash, cash equivalents and investments as of September 30, 2025 of approximately $555.5 million, less $30 million of upfront and near-term milestone payments payable to Leads Biolabs.

  • R&D Expenses - Research and development (R&D) expenses for the quarter ended September 30, 2025 were $32.5 million, inclusive of $2.5 million of stock-based compensation, compared to $25.5 million for the quarter ended September 30, 2024, which included $1.7 million of stock-based compensation. This increase in R&D expenses was primarily driven by higher clinical costs, milestone costs, and increased headcount to support claseprubart Phase 2 and Phase 3 development.

  • G&A Expenses - General and administrative (G&A) expenses for the quarter ended September 30, 2025 totaled $8.2 million, inclusive of stock-based compensation of $3.3 million, compared to $6.5 million for the quarter ended September 30, 2024, which included $2.2 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, 2025 was $36.8 million or $0.97 per share (basic and diluted) compared to $25.2 million or $0.74 per share (basic and diluted) for the quarter ended September 30, 2024.

  • Additional Information - For additional information on the Company’s financial results for the quarter ended September 30, 2025, 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-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Dianthus is building a neuromuscular franchise with claseprubart and expects to initiate a Phase 3 trial in gMG in 2026, the interim responder analysis of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy in Q2’26, and top-line data from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy in 2H’26.

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

DNTH212 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 and DNTH212, and any developments or results in connection therewith, including the target product profile and administration of claseprubart and DNTH212; 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 opportunities for complement therapies, in particular with respect to claseprubart and DNTH212. Claseprubart and DNTH212 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 and DNTH212 and data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that the development of claseprubart or DNTH212 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, 2024, 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


DIANTHUS THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
(unaudited)
 
 September 30,
2025
  December 31,
2024
 
Assets     
Current assets:     
Cash and cash equivalents$55,984  $22,792 
Short-term investments 346,629   252,449 
Receivable from former related party    807 
Accounts receivable, net 5,000    
Prepaid expenses and other current assets 6,212   4,856 
Total current assets 413,825   280,904 
Long-term investments 152,874   81,728 
Property and equipment, net 185   194 
Right-of-use operating lease assets 1,306   1,553 
Other assets and restricted cash 9,255   9,629 
Total assets$577,445  $374,008 
Liabilities and Stockholders’ Equity     
Current liabilities:     
Accounts payable$6,705  $4,579 
Accrued expenses 15,979   13,074 
Current portion of deferred revenue 954   479 
Current portion of operating lease liabilities 217   320 
Total current liabilities 23,855   18,452 
Deferred revenue 6,068   1,908 
Long-term operating lease liabilities 1,068   1,171 
Total liabilities 30,991   21,531 
Commitments and contingencies     
Stockholders’ equity:     
Preferred stock     
Common stock 43   31 
Additional paid-in capital 818,545   526,732 
Accumulated deficit (272,297)  (174,392)
Accumulated other comprehensive income 163   106 
Total stockholders’ equity 546,454   352,477 
Total liabilities and stockholders’ equity$577,445  $374,008 


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,
 
 2025  2024  2025  2024 
Revenues:           
License revenue – former related party$  $2,172  $  $4,909 
License revenue 396      1,752    
Total revenues 396   2,172   1,752   4,909 
Operating expenses:           
Research and development 32,489   25,544   85,743   56,692 
General and administrative 8,195   6,528   24,401   18,165 
Total operating expenses 40,684   32,072   110,144   74,857 
Loss from operations (40,288)  (29,900)  (108,392)  (69,948)
Other income/(expense):           
Interest and investment income 3,658   4,445   10,852   13,375 
Gain on investment in former related party 227   307   254   307 
Loss on currency exchange, net (2)  (48)  (54)  (91)
Other (expense)/income (360)  22   (565)  (172)
Total other income 3,523   4,726   10,487   13,419 
Net loss$(36,765) $(25,174) $(97,905) $(56,529)
Net loss per share attributable to common stockholders,
basic and diluted
$(0.97) $(0.74) $(2.68) $(1.73)
Weighted-average number of shares of common stock
outstanding including shares issuable under equity classified pre-funded warrants, used in computing net loss per share of common stock, basic and diluted
 37,794,088   34,236,728   36,476,370   32,614,771 
Comprehensive loss:           
Net loss$(36,765) $(25,174) $(97,905) $(56,529)
Other comprehensive income:           
Unrealized gain on marketable securities 65   718   57   634 
Total other comprehensive income 65   718   57   634 
Total comprehensive loss$(36,700) $(24,456) $(97,848) $(55,895)



FAQ

What did Dianthus (DNTH) report for cash and runway in Q3 2025?

Dianthus reported an estimated adjusted cash position of ~$525M, which the company says provides runway into 2028.

What were the Q3 2025 earnings metrics for DNTH (net loss and R&D)?

DNTH reported a Q3 2025 net loss of $36.8M (or $0.97 per share) and R&D expenses of $32.5M.

How did claseprubart perform in the Phase 2 MaGic gMG trial presented at AANEM?

Claseprubart showed rapid, statistically significant and clinically meaningful improvements in MG-ADL and QMG, including at Week 1 and Week 13, with no drug-related SAEs reported.

When will DNTH start Phase 3 for claseprubart in gMG and what doses will be tested?

Dianthus plans to initiate a Phase 3 gMG trial in 2026 testing 300mg/2mL Q2W and 300mg/2mL Q4W versus placebo.

Why was the CIDP CAPTIVATE interim analysis for DNTH accelerated and when is it expected?

The interim responder analysis was accelerated due to faster-than-expected enrollment and is now expected in Q2’26.

What is DNTH212 and when will its Phase 1 data be available?

DNTH212 is a bifunctional BDCA2 and BAFF/APRIL inhibitor licensed by Dianthus; Phase 1 healthy volunteer top-line data are anticipated in 2H’26.
Dianthus Therapeutics Inc

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