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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

Date of Report (Date of earliest event reported): March 11, 2025

 

 

DIANTHUS THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-38541

81-0724163

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

7 Times Square

43rd Floor

 

New York, New York

 

10036

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 929 999-4055

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

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)

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

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:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, $0.001 Par Value

 

DNTH

 

The Nasdaq Capital Market

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 March 11, 2025, Dianthus Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter and full year ended December 31, 2024. 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, 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.

Description

99.1

Press release dated March 11, 2025

104

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.

 

 

 

DIANTHUS THERAPEUTICS, INC.

 

 

 

 

Date:

March 11, 2025

By:

/s/ Adam M. Veness, Esq.

 

 

 

Adam M. Veness, Esq.
SVP, General Counsel and Secretary

 


EX-99.1 2 dnth-ex99_1.htm EX-99.1 EX-99.1

 

img85518887_0.jpg

 

DIANTHUS THERAPEUTICS HIGHLIGHTS RECENT BUSINESS ACHIEVEMENTS

AND REPORTS Q4 AND FY 2024 FINANCIAL RESULTS

 

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 City and Waltham, Mass., March 11, 2025 – 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.

 

 

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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.

 

 

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About DNTH103
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. 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 Therapeutics

Dianthus 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.

 

 

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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 Ruff

Dianthus Therapeutics

jdavisruff@dianthustx.com

 

 

 

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Dianthus Therapeutics, Inc.

Consolidated Balance Sheets

(in thousands, except share and per share data)

(unaudited)

 

December 31,
2024

December 31,
2023

ASSETS

Current 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 STOCKHOLDER’ 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

 

 

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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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