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Dianthus Therapeutics Highlights Recent Business Achievements and Reports Q4 and FY 2024 Financial Results

1. DNTH103's Phase 2 trial in gMG reports results in 2H’25. 2. CAPTIVATE trial in CIDP anticipates analysis in 2H’26. 3. Company has $357 million cash, funding through 2H’27. 4. Increased R&D expenses indicate ongoing clinical development push. 5. Executive changes may enhance commercial strategies and execution.

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Why Bullish?

The ongoing clinical trials for DNTH103 could lead to significant market potential. Historically, positive trial results often correlate with stock price appreciation in biotech firms.

How important is it?

The ongoing trials and financial stability position DNTH as a strong candidate in biotech. With upcoming results, the stock's performance may be positively influenced due to investor interest in novel therapies.

Why Short Term?

Top-line results from the gMG Phase 2 trial will be reported soon, offering immediate market impact. Biotech stocks typically react quickly to clinical updates.

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AMGNREGNRGEN
March 11, 2025 16:01 ET  | Source: Dianthus Therapeutics, Inc. Phase 2 MaGic trial of DNTH103 in generalized Myasthenia Gravis (gMG) ongoing; top-line results on track for 2H’25 Phase 3 CAPTIVATE trial of DNTH103 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) ongoing; interim responder analysis anticipated in 2H’26 Phase 2 MoMeNtum trial of DNTH103 in Multifocal Motor Neuropathy (MMN) ongoing; top-line results anticipated in 2H’26 $357.0 million of cash provides runway into 2H’27 NEW YORK and WALTHAM, Mass., March 11, 2025 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today reported financial results for the fourth quarter and full year ending December 31, 2024 and provided an update on recent business achievements. “We remain on track to report top-line data in 2H’25 from our Phase 2 clinical trial of DNTH103 in gMG, an indication where a best-in-class, potent active C1s and classical pathway inhibitor with the potential for effective and consistent symptom control along with improved safety and convenience could meaningfully advance the standard of care,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “We are excited to have initiated our pivotal Phase 3 CAPTIVATE trial in CIDP, which is on track for an interim responder analysis in 2H’26, along with top-line results from our Phase 2 trial in MMN.” DNTH103 Clinical Development DNTH103 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. DNTH103 is enhanced with YTE half-life extension technology designed to enable a more convenient subcutaneous, self-administered injection dosed as infrequently as once every two weeks. DNTH103 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) Phase 2 MaGic gMG trial ongoing: The MaGic trial is a global, randomized, double-blind, placebo-controlled Phase 2 trial in patients with gMG who are acetylcholine receptor (AChR) antibody positive, and it remains on track to report top-line results in 2H’25. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 3 CAPTIVATE CIDP trial ongoing: The CAPTIVATE trial is a single, global, two-part, randomized withdrawal Phase 3 trial in patients with CIDP, and it remains on track for an interim responder analysis in 2H’26. 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 ongoing: The MoMeNtum trial is a global, randomized, double-blind, placebo-controlled Phase 2 trial in patients with MMN, and it remains on track to report top-line results in 2H’26. Corporate Updates On March 5, 2025, John C. King was announced as Chief Commercial Officer and Sujay Kango joined the Company’s Board of Directors. Mr. King brings to Dianthus more than 25 years of global commercial leadership experience in biotechnology, including neuromuscular and hematological rare diseases. Mr. Kango is an experienced executive with more than 26 years of experience in the pharmaceutical and biotechnology sector. Full Year 2024 Financial Results Cash Position - $357.0 million of cash, cash equivalents and investments as of December 31, 2024 is projected to provide runway into the second half of 2027. R&D Expenses - Research and development (R&D) expenses for the year ended December 31, 2024 were $83.1 million, inclusive of $5.6 million of stock-based compensation, compared to $32.8 million for the year ended December 31, 2023, which included $0.9 million of stock-based compensation. This increase in R&D expenses was primarily driven by higher clinical costs, chemistry, manufacturing and controls (CMC) costs and increased headcount to support DNTH103 Phase 2 and Phase 3 development. G&A Expenses - General and administrative (G&A) expenses for the year ended December 31, 2024 totaled $25.0 million, inclusive of stock-based compensation of $7.3 million, compared to $18.2 million for the year ended December 31, 2023, which included $2.0 million of stock-based compensation. This increase in G&A expenses was primarily due to increased headcount and higher professional services costs. Net Loss - Net loss for the year ended December 31, 2024 was $85.0 million or $2.55 per share (basic and diluted) compared to $43.6 million or $8.45 per share (basic and diluted) for the year ended December 31, 2023. Additional Information - For additional information on the Company’s financial results for the year ended December 31, 2024, please refer to the Form 10-K filed with the SEC. About DNTH103DNTH103 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. DNTH103 is enhanced with YTE half-life extension technology designed to enable a more convenient subcutaneous, self-administered injection dosed as infrequently as once every two weeks. 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, DNTH103 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 DNTH103 and anticipates reporting top-line data from the Phase 2 MaGic trial in generalized Myasthenia Gravis in 2H’25, the interim responder analysis of the Phase 3 CAPITIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy in 2H’26, and top-line data from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy in 2H’26. DNTH103 is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. About Dianthus TherapeuticsDianthus Therapeutics is a clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming 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 DNTH103, and any developments or results in connection therewith, including the target product profile of DNTH103; the anticipated timing of the initiation and results from those studies and trials; 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 the market and potential opportunities for complement therapies, in particular with respect to DNTH103. 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 DNTH103 and data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that the development of DNTH103 or the Company's other compounds may take longer and/or cost more than planned, that the Company may be unable to successfully complete the clinical development of the Company’s compounds, that the Company 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 RuffDianthus Therapeuticsjdavisruff@dianthustx.com  Dianthus Therapeutics, Inc.Consolidated Balance Sheets(in thousands, except share and per share data)(unaudited)    ASSETSDecember 31,2024 December 31,2023Current assets:   Cash and cash equivalents$22,792  $132,325 Short-term investments 252,449   41,393 Receivable from related party 807   294 Unbilled receivable from related party —   184 Prepaid expenses and other current assets 4,856   3,255 Total current assets 280,904   177,451     Long-term investments 81,728   — Property and equipment, net 194   185 Right-of-use operating lease assets 1,553   615 Other assets and restricted cash 9,629   1,154 Total assets$374,008  $179,405     LIABILITIES AND STOCKHOLDERS’ EQUITY   Current liabilities:   Accounts payable$4,579  $2,610 Accrued expenses 13,074   6,504 Current portion of deferred revenue 479   — Current portion of deferred revenue – related party —   100 Current portion of operating lease liabilities 320   417 Total current liabilities 18,452   9,631     Deferred revenue 1,908   — Deferred revenue – related party —   736 Long-term operating lease liabilities 1,171   168 Total liabilities 21,531   10,535     Commitments and contingencies   Stockholders' equity:   Preferred stock —   — Common stock 31   15 Additional paid-in capital 526,732   258,231 Accumulated deficit (174,392)  (89,423)Accumulated other comprehensive income 106   47 Total stockholders' equity 352,477   168,870 Total liabilities and stockholders' equity$374,008  $179,405    Dianthus Therapeutics, Inc.Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(unaudited)         Three Months Ended December 31, Year Ended December 31,  2024   2023   2024   2023 Revenues:       License revenue – related party$999  $457  $5,909  $2,826 License revenue 326   —   326   — Total revenues 1,325   457   6,235   2,826         Operating expenses:       Research and development 26,413   8,781   83,105   32,841 General and administrative 6,828   4,632   24,994   18,159 Total operating expenses 33,241   13,413   108,099   51,000         Loss from operations (31,916)  (12,956)  (101,864)  (48,174)        Other income/(expense):       Interest income 3,991   2,444   17,365   4,764 Gain/(loss) on investment in related party (160)  —   148   — Gain/(loss) on currency exchange, net 27   (32)  (64)  (85)Other expense (380)  (19)  (554)  (60)Total other income 3,478   2,393   16,895   4,619         Net loss$(28,438) $(10,563) $(84,969) $(43,555)        Net loss per share attributable to common stockholders, basic and diluted$(0.81) $(0.71) $(2.55) $(8.45)        Weighted-average number of shares of common stock outstanding, used in computing net loss per share of common stock, basic and diluted 35,033,773   14,817,676   33,313,849   5,153,423         Comprehensive loss:       Net Loss$(28,438) $(10,563) $(84,969) $(43,555)Other comprehensive income/(loss):       Unrealized gains/(losses) on marketable securities (575)  51   59   208 Total other comprehensive income/(loss) (575)  51   59   208 Total comprehensive loss$(29,013) $(10,512) $(84,910) $(43,347)

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