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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): November 7, 2024

 

 

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. ☐

 

 

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Item 2.02 Results of Operations and Financial Condition.

On November 7, 2024, Dianthus Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended September 30, 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 November 7, 2024
104		Cover Page Interactive Data File (embedded within the inline XBRL document)

 

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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:	November 7, 2024	By:	/s/ Adam M. Veness, Esq.
			Adam M. Veness, Esq. SVP, General Counsel and Secretary

 

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DIANTHUS THERAPEUTICS HIGHLIGHTS RECENT BUSINESS ACHIEVEMENTS

AND REPORTS Q3 FINANCIAL RESULTS

 

Initiation of a single, two-part, pivotal Phase 3 trial of DNTH103 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) anticipated by YE’24

 

Phase 2 MaGic trial of DNTH103 in generalized Myasthenia Gravis (gMG) ongoing;

top-line results anticipated in 2H’25

 

Phase 2 MoMeNtum trial of DNTH103 in Multifocal Motor Neuropathy (MMN) ongoing;

top-line results anticipated in 2H’26

 

Approximately $343 million of cash provides runway into 2H’27

 

New York City and Waltham, Mass., November 7, 2024 – 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 third quarter ending September 30, 2024 and provided an update on recent business achievements.

 

“We are excited to expand DNTH103 beyond gMG and MMN into CIDP before year end. Like gMG and MMN, CIDP has significant unmet needs where a best-in-class, potent classical pathway inhibitor can potentially make a meaningful difference in the lives of patients. We believe this single, two-part, pivotal Phase 3 trial will support BLA filing in adult patients with CIDP and we anticipate initiating the trial by year-end 2024,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “We continue to be confident in the pipeline-in-a-product potential of DNTH103 across multiple autoimmune diseases, supported by our proof-of-concept in vitro data most recently presented at AANEM and ICNMD and competitor clinical data that further validate targeting the classical pathway and active C1s.”

 

 

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.

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Generalized Myasthenia Gravis (gMG)

 

 

 

Multifocal Motor Neuropathy (MMN)

 

 

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

 

 

 

Corporate Updates

 

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Third-Quarter 2024 Financial Results

 

 

 

 

 

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 following the initiation of the Phase 2 MaGic trial in generalized Myasthenia Gravis in 1Q’24 and the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy in 3Q’24, and initiation of a Phase 3 trial in Chronic Inflammatory Demyelinating Polyneuropathy anticipated by YE’24.

 

DNTH103 is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide.

 

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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.

 

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, 2023, 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.

 

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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.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

(unaudited)

		September 30, 2024				December 31, 2023
Assets
Current assets:
Cash and cash equivalents		$	33,671			$	132,325
Short-term investments			247,452				41,393
Receivable from related party			1,390				294
Unbilled receivable from related party			1,293				184
Prepaid expenses and other current assets			3,683				3,255
Total current assets			287,489				177,451
Long-term investments			61,482				—
Property and equipment, net			189				185
Right-of-use operating lease assets			352				615
Other assets and restricted cash			4,736				1,154
Total assets		$	354,248			$	179,405
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	7,572			$	2,610
Accrued expenses			7,727				6,504
Current portion of deferred revenue - related party			100				100
Current portion of operating lease liabilities			311				417
Total current liabilities			15,710				9,631
Deferred revenue - related party			640				736
Long-term operating lease liabilities			—				168
Total liabilities			16,350				10,535
Commitments and contingencies
Stockholders’ equity:
Preferred stock			—				—
Common stock			29				15
Additional paid-in capital			483,140				258,231
Accumulated deficit			(145,952	)			(89,423	)
Accumulated other comprehensive income			681				47
Total stockholders’ equity			337,898				168,870
Total liabilities and stockholders’ equity		$	354,248			$	179,405

 

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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,
		2024				2023				2024				2023
Revenues:
License revenue - related party		$	2,172			$	924			$	4,909			$	2,369
Operating expenses:
Research and development			25,544				7,960				56,692				24,060
General and administrative			6,528				8,723				18,165				13,527
Total operating expenses			32,072				16,683				74,857				37,587
Loss from operations			(29,900	)			(15,759	)			(69,948	)			(35,218	)
Other income/(expense):
Interest income			4,445				1,027				13,375				2,320
Gain on investment in related party			307				—				307				—
Loss on currency exchange, net			(48	)			(16	)			(91	)			(53	)
Other income/(expense)			22				(15	)			(172	)			(41	)
Total other income			4,726				996				13,419				2,226
Net loss		$	(25,174	)		$	(14,763	)		$	(56,529	)		$	(32,992	)
Net loss per share attributable to common stockholders, basic and diluted		$	(0.74	)		$	(3.78	)		$	(1.73	)		$	(17.40	)
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			34,236,728				3,906,886				32,614,771				1,896,605
Comprehensive loss:
Net loss		$	(25,174	)		$	(14,763	)		$	(56,529	)		$	(32,992	)
Other comprehensive income:
Change in unrealized gains related to available for-sale debt securities			718				15				634				157
Total other comprehensive income			718				15				634				157
Total comprehensive loss		$	(24,456	)		$	(14,748	)		$	(55,895	)		$	(32,835	)

 

 

 

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