UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
|
(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:
|
|
Trading |
|
|
|
|
The |
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 August 8, 2024, Dianthus Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended June 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 |
|
|
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: |
August 8, 2024 |
By: |
/s/ Adam M. Veness, Esq. |
|
|
|
Adam M. Veness, Esq. |
DIANTHUS THERAPEUTICS HIGHLIGHTS RECENT BUSINESS ACHIEVEMENTS
AND REPORTS Q2 FINANCIAL RESULTS
Phase 2 MaGic trial in generalized Myasthenia Gravis (gMG) ongoing;
top-line results anticipated in 2H’25
IND for Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy (MMN) cleared by FDA in June;
top-line results anticipated in 2H’26
Phase 2 trial in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to initiate 2H’24
Approximately $361 million of cash provides runway into 2H’27
New York City and Waltham, Mass., August 8, 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 second quarter ending June 30, 2024, and provided an update on recent business achievements.
“The second quarter of 2024 highlighted the Dianthus team’s continued focus on execution and operational excellence as we advance our clinical programs for DNTH103 in generalized Myasthenia Gravis, Multifocal Motor Neuropathy, and Chronic Inflammatory Demyelinating Polyneuropathy,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “We believe DNTH103 may be a potentially best-in-class, potent classical complement pathway inhibitor with infrequent, subcutaneous self-administration and a differentiated safety profile across our three initial indications of gMG, MMN and CIDP. 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 presented at EAN and recent competitor clinical data that further validate targeting the classical pathway and active C1s.”
Recent Business Highlights and Upcoming Milestones
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. DNTH103 has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need.
1
www.dianthustx.com 7 Times Square, Floor 43 New York, NY 10036
Corporate
Second-Quarter 2024 Financial Results
2
www.dianthustx.com 7 Times Square, Floor 43 New York, NY 10036
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, regulatory clearance for Multifocal Motor Neuropathy in 2Q’24, and planned initiation of a Phase 2 trial in Chronic Inflammatory Demyelinating Polyneuropathy in 2H’24.
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.
3
www.dianthustx.com 7 Times Square, Floor 43 New York, NY 10036
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.
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
4
www.dianthustx.com 7 Times Square, Floor 43 New York, NY 10036
Dianthus Therapeutics, Inc. |
|||
Condensed Consolidated Balance Sheets |
|||
(in thousands, except share and per share data) (unaudited) |
|||
|
|
|
|
ASSETS |
June 30, |
|
December 31, |
Current assets: |
|
|
|
Cash and cash equivalents |
$ 314,169 |
|
$ 132,325 |
Short-term investments |
46,538 |
|
41,393 |
Receivable from related party |
840 |
|
294 |
Unbilled receivable from related party |
835 |
|
184 |
Prepaid expenses and other current assets |
3,305 |
|
3,255 |
Total current assets |
365,687 |
|
177,451 |
|
|
|
|
Property and equipment, net |
189 |
|
185 |
Right-of-use operating lease assets |
442 |
|
615 |
Other assets and restricted cash |
2,641 |
|
1,154 |
Total assets |
$ 368,959 |
|
$ 179,405 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ 3,695 |
|
$ 2,610 |
Accrued expenses |
5,857 |
|
6,504 |
Current portion of deferred revenue – related party |
100 |
|
100 |
Current portion of operating lease liabilities |
377 |
|
417 |
Total current liabilities |
10,029 |
|
9,631 |
|
|
|
|
Deferred revenue – related party |
682 |
|
736 |
Long-term operating lease liabilities |
30 |
|
168 |
Total liabilities |
10,741 |
|
10,535 |
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock |
- |
|
- |
Common stock |
29 |
|
15 |
Additional paid-in capital |
479,004 |
|
258,231 |
Accumulated deficit |
(120,778) |
|
(89,423) |
Accumulated other comprehensive income/(loss) |
(37) |
|
47 |
Total stockholders' equity |
358,218 |
|
168,870 |
Total liabilities and stockholders' equity |
$ 368,959 |
|
$ 179,405 |
5
www.dianthustx.com 7 Times Square, Floor 43 New York, NY 10036
Dianthus Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
License revenue - related party |
|
$ |
1,863 |
|
|
$ |
969 |
|
|
$ |
2,737 |
|
|
$ |
1,445 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
18,070 |
|
|
|
10,253 |
|
|
|
31,148 |
|
|
|
16,100 |
|
General and administrative |
|
|
5,997 |
|
|
|
2,492 |
|
|
|
11,637 |
|
|
|
4,804 |
|
Total operating expenses |
|
|
24,067 |
|
|
|
12,745 |
|
|
|
42,785 |
|
|
|
20,904 |
|
Loss from operations |
|
|
(22,204 |
) |
|
|
(11,776 |
) |
|
|
(40,048 |
) |
|
|
(19,459 |
) |
Other income/(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
4,708 |
|
|
|
687 |
|
|
|
8,930 |
|
|
|
1,293 |
|
Loss on currency exchange, net |
|
|
(31 |
) |
|
|
(28 |
) |
|
|
(43 |
) |
|
|
(37 |
) |
Other expense |
|
|
(80 |
) |
|
|
(23 |
) |
|
|
(194 |
) |
|
|
(26 |
) |
Total other income |
|
|
4,597 |
|
|
|
636 |
|
|
|
8,693 |
|
|
|
1,230 |
|
Net loss |
|
$ |
(17,607 |
) |
|
$ |
(11,140 |
) |
|
$ |
(31,355 |
) |
|
$ |
(18,229 |
) |
Net loss per share attributable to common stockholders, |
|
$ |
(0.51 |
) |
|
$ |
(12.73 |
) |
|
$ |
(0.99 |
) |
|
$ |
(20.84 |
) |
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 |
|
|
34,227,038 |
|
|
|
874,900 |
|
|
|
31,794,881 |
|
|
|
874,805 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
(17,607 |
) |
|
$ |
(11,140 |
) |
|
$ |
(31,355 |
) |
|
$ |
(18,229 |
) |
Other comprehensive (loss)/income: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Change in unrealized (losses)/gains related to available-for-sale debt securities |
|
|
(10 |
) |
|
|
38 |
|
|
|
(84 |
) |
|
|
142 |
|
Total other comprehensive (loss)/income |
|
|
(10 |
) |
|
|
38 |
|
|
|
(84 |
) |
|
|
142 |
|
Total comprehensive loss |
|
$ |
(17,617 |
) |
|
$ |
(11,102 |
) |
|
$ |
(31,439 |
) |
|
$ |
(18,087 |
) |
6
www.dianthustx.com 7 Times Square, Floor 43 New York, NY 10036