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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 9, 2023

 

 

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 9, 2023, Dianthus Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended September 30, 2023. 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 9, 2023
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 9, 2023	By:	/s/ Adam M. Veness, Esq.
			Adam M. Veness, Esq. SVP, General Counsel and Secretary

 

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Exhibit 99.1

Dianthus Therapeutics Highlights Recent Business Achievements and Third Quarter 2023 Financial Results

Began trading on Nasdaq under the ticker symbol DNTH following the successful completion of our merger with Magenta Therapeutics

Completed concurrent $72 million financing with a syndicate of leading life-science investors

Announced positive top-line Phase 1 data for lead clinical program, DNTH103, confirming potent classical complement pathway inhibition, extended half-life, and a potentially differentiated safety profile

On track to advance DNTH103 into Phase 2 trials targeting multiple neuromuscular indications in 2024, starting with generalized Myasthenia Gravis in Q1 2024

Robust balance sheet, closing the quarter with over $189 million of cash runway expected to fund operations into Q2 2026

New York City and Waltham, Mass., November 9, 2023 – 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, 2023 and provided an update on recent business achievements.

 

“This was a landmark quarter of progress and momentum for Dianthus, marked by the positive top-line results for our lead clinical program, DNTH103, validating its best-in-class potential as well as our exciting transition to the public markets with a robust balance sheet,” said Marino Garcia, President and Chief Executive Officer of Dianthus Therapeutics. “As we look ahead, we remain on track to progress DNTH103 into Phase 2 trials for multiple neuromuscular indications where we have the potential to develop a new standard of care, beginning with generalized Myasthenia Gravis in the first quarter of 2024, followed by Multifocal Motor Neuropathy and Chronic Inflammatory Demyelinating Polyneuropathy. We’re particularly energized by the high level of engagement and interest we’ve seen from leading clinicians and investigators globally due to DNTH103’s potentially differentiated profile as a potent active C1s inhibitor with infrequent, subcutaneous self-administration. We are encouraged by the potential of DNTH103 to address both the disease and treatment burdens that disrupt the lives of patients suffering from severe autoimmune diseases, and we look forward to providing updates on our progress in the coming months.”

 

Recent Business Highlights and Upcoming Milestones

 

DNTH103

DNTH103 is an investigational, potent monoclonal antibody designed to selectively target the active form of the C1s protein, a clinically validated complement target within the classical

 

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pathway. 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. Engineered with validated YTE half-life extension technology, DNTH103 is intended to be the first subcutaneous complement therapy that can be self-administered as infrequently as once every two weeks for a range of severe, classical pathway-driven autoimmune disorders, beginning with generalized Myasthenia Gravis (gMG), Multifocal Motor Neuropathy (MMN), and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

 

Corporate

 

Third Quarter Financial Results

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About DNTH103

DNTH103 is an investigational, long-acting monoclonal antibody designed to selectively target the active form of the C1s protein, a clinically validated complement target within the classical pathway. 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 plans to initiate Phase 2 trials in multiple neuromuscular indications in 2024, starting with generalized Myasthenia Gravis in the first quarter of 2024.

 

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 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,”

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“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 Exhibit 99.1 to the Company’s Form 8-K/A filed on September 21, 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.

 

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.

 

Media Contact

Peg Rusconi

Verge Scientific Communications

prusconi@vergescientific.com

 

 

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Dianthus Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data) (unaudited)
ASSETS	September 30, 2023		December 31, 2022
Current assets:
Cash and cash equivalents	$ 157,282		$ 15,365
Short-term investments	32,588		60,125
Receivable from related party	232		4,700
Unbilled receivable from related party	519		938
Prepaid expenses and other current assets	832		905
Total current assets	191,453		82,033
Property and equipment, net	195		142
Right-of-use lease assets	698		814
Other assets and restricted cash	116		121
Total assets	$ 192,462		$ 83,110
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY/(DEFICIT)
Current liabilities:
Accounts payable	$ 1,369		$ 1,167
Accrued expenses	11,197		6,608
Current portion of deferred revenue – related party	100		100
Current portion of lease liabilities	413		350
Total current liabilities	13,079		8,225
Deferred revenue – related party	745		791
Long-term lease liabilities	257		438
Total liabilities	14,081		9,454
Commitments and contingencies
Convertible preferred stock	-		118,024
Stockholders' equity/(deficit):
Preferred stock	-		-
Common stock	15		-
Additional paid-in capital	257,230		1,661
Accumulated deficit	(78,860)		(45,868)
Accumulated other comprehensive loss	(4)		(161)
Total stockholders' equity/(deficit)	178,381		(44,368)
Total liabilities and stockholders' equity/(deficit)	$ 192,462		$ 83,110

 

 

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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,
	2023		2022		2023		2022
Revenues:
License revenue – related party	$ 924		$ 1,173		$ 2,369		$ 5,242
Operating expenses:
Research and development	7,960		7,218		24,060		19,548
General and administrative	8,723		2,209		13,527		4,706
Total operating expenses	16,683		9,427		37,587		24,254
Loss from operations	(15,759)		(8,254)		(35,218)		(19,012)
Other income/(expense):
Interest income	1,027		416		2,320		505
(Loss)/gain on currency exchange, net	(16)		56		(53)		156
Other expense	(15)		(2)		(41)		(9)
Total other income	996		470		2,226		652
Net loss	$ (14,763)		$ (7,784)		$ (32,992)		$ (18,360)
Net loss per share attributable to common stockholders, basic and diluted	$ (3.78)		$ (8.90)		$ (17.40)		$ (21.00)
Weighted-average number of common
shares outstanding used in computing net loss per common share, basic and diluted	3,906,886		874,327		1,896,605		874,138
Comprehensive loss:
Net Loss	$ (14,763)		$ (7,784)		$ (32,992)		$ (18,360)
Other comprehensive income/(loss):
Change in unrealized losses related to   available-for-sale debt securities	15		(150)		157		(150)
Total other comprehensive income/(loss)	15		(150)		157		(150)
Total comprehensive loss	$ (14,748)		$ (7,934)		$ (32,835)		$ (18,510)

 

 

 

 

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