Dianthus Therapeutics, Inc 10-Q for FY2025 Q2
Dianthus Therapeutics, Inc. /DE/ (DNTH)
About this 10-Q
Dianthus Therapeutics, Inc filed this 10-Q on August 7, 2025, covering the quarter ended June 30, 2025 (FY2025 Q2).
Headline figures
Quarter ended June 30, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $193K
- down 89.6% from $1.86M a year earlier
- Net loss
- $31.63M
- compared with a net loss of $17.61M a year earlier
- Diluted EPS
- -$0.88
- compared with -$0.51 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from _________________ to _________________
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Name of each exchange on which registered |
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The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of August 6, 2025, the registrant had
Table of Contents
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Page |
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PART I. |
1 |
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Item 1. |
1 |
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1 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
2 |
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Condensed Consolidated Statements of Changes in Stockholders’ Equity |
3 |
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4 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
5 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
22 |
Item 3. |
34 |
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Item 4. |
34 |
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PART II. |
35 |
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Item 1. |
35 |
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Item 1A. |
35 |
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Item 2. |
36 |
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Item 3. |
36 |
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Item 4. |
36 |
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Item 5. |
36 |
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Item 6. |
37 |
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38 |
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i
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts, included in this Quarterly Report on Form 10-Q are forward-looking statements, including, without limitation, statements concerning our plans, objectives, goals, expectations, hopes, beliefs, intentions, assumptions, projections, estimates or strategies and any underlying assumptions regarding the future, our future results of operations and financial position, including the sufficiency of our existing cash resources to fund our operations for as long as anticipated, our liquidity, capital resources, costs and expenses, capital requirements, commitments and contingencies, the development or commercial potential of claseprubart, formerly referred to as DNTH103, or any other product candidate, our anticipated preclinical and clinical drug development activities, in particular with respect to claseprubart, and any timelines, developments or results in connection therewith, including the timing of data, the efficacy, safety profile, dosing amount or frequency, method of delivery or other potential therapeutic benefits of claseprubart, the receipt or timing of potential regulatory designations, approvals and commercialization of any product candidates, market size or addressable patient population and other statements, including those included under the sections titled “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report on Form 10-Q. In some cases, you can identify forward-looking statements by terms such as “aim,” “may,” “might,” “will,” “would,” “shall,” “objective,” “intend,” “target,” “should,” “could,” “can,” “expect,” “anticipate,” “believe,” “design,” “estimate,” “forecast,” “predict,” “project,” “potential,” “possible,” “plan,” “seek,” “contemplate,” “goal,” “likely” or “continue” or the negative of these terms and similar expressions intended to identify forward-looking statements, but the absence of these terms does not mean that a statement is not forward-looking. Forward-looking statements are not historical facts and are based on our current expectations and beliefs with respect to future events and their potential effects and impacts. There can be no assurance that future events affecting us will be those that have been anticipated. Given the significant risks and uncertainties, you should not place undue reliance on these forward-looking statements.
There are a number of risks, uncertainties and other factors that could cause our actual results or outcomes, or the timing of our results or outcomes, to differ materially from the forward-looking statements expressed or implied in this Quarterly Report on Form 10-Q. Such risks, uncertainties and other factors include, among others, the following:
ii
There may be other factors that may cause our actual results or outcomes, or the timing of those results or outcomes, to differ materially from the forward-looking statements expressed or implied in this Quarterly Report on Form 10-Q, including factors disclosed in the sections titled “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report on Form 10-Q, in the section titled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our other filings with the Securities and Exchange Commission (the “SEC”). You should evaluate all forward-looking statements made in this Quarterly Report on Form 10-Q in the context of these risks and uncertainties.
We caution you that the risks, uncertainties and other factors referred to above and elsewhere in this Quarterly Report on Form 10-Q may not contain all of the risks, uncertainties and other factors that may affect our future results, operations and outcomes. Moreover, new risks emerge from time to time. It is not possible for us to predict all risks. In addition, we cannot assure you that we will realize the results, benefits or developments that we expect or anticipate or, even if substantially realized, that they will result in the consequences or affect us or our business in the way expected. Past performance is not indicative of future performance.
Any forward-looking statements contained in this Quarterly Report on Form 10-Q apply only as of the date of this Quarterly Report on Form 10-Q and are expressly qualified in their entirety by the cautionary statements included in this Quarterly Report on Form 10-Q. Except as required by law, we disclaim any intent to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changes in assumptions or otherwise.
iii
Explanatory Note
Unless context otherwise requires, references to “we,” “our,” “us,” “Dianthus,” the “Company,” or the “combined company” in this Quarterly Report on Form 10-Q refer to Dianthus Therapeutics, Inc. (formerly Magenta Therapeutics, Inc.) for the period after the completion of the Reverse Merger (as defined below) and refer to Dianthus Therapeutics OpCo, Inc. for the period before the completion of the Reverse Merger. The term “Former Dianthus” also refers to Dianthus Therapeutics OpCo, Inc. (formerly Dianthus Therapeutics, Inc.), and the term “Magenta” refers to the Company prior to completion of the Reverse Merger. On September 11, 2023, we completed a business combination with Former Dianthus pursuant to which, among other matters, Former Dianthus became a wholly owned subsidiary of ours (the “Reverse Merger”).
iv
PART I—FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements (Unaudited)
DIANTHUS THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
(unaudited)
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June 30, |
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December 31, |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Short-term investments |
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Receivable from related party |
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Accounts receivable, net |
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Prepaid expenses and other current assets |
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Total current assets |
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Long-term investments |
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Property and equipment, net |
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Right-of-use operating lease assets |
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Other assets and restricted cash |
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Total assets |
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$ |
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$ |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses |
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Current portion of deferred revenue |
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Current portion of operating lease liabilities |
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Total current liabilities |
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Deferred revenue |
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Long-term operating lease liabilities |
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Total liabilities |
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Stockholders’ equity: |
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Preferred stock; $ |
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Common stock; $ |
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Additional paid-in capital |
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Accumulated deficit |
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( |
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( |
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Accumulated other comprehensive income |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
1
DIANTHUS THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended |
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Six Months Ended |
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2025 |
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2024 |
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2025 |
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2024 |
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Revenues: |
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License revenue - former related party |
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$ |
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$ |
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$ |
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$ |
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License revenue |
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Total revenues |
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Operating expenses: |
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Research and development |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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( |
) |
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( |
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( |
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( |
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Other income/(expense): |
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Interest and investment income |
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Gain on investment in former related party |
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Loss on currency exchange, net |
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( |
) |
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( |
) |
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( |
) |
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( |
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Other expense |
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( |
) |
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( |
) |
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( |
) |
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( |
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Total other income |
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Net loss |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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Net loss per share attributable to common stockholders, |
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$ |
( |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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Weighted-average number of shares of common stock outstanding |
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Comprehensive loss: |
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Net loss |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
Other comprehensive loss: |
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Unrealized loss on marketable securities |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
Total other comprehensive loss |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
Total comprehensive loss |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
DIANTHUS THERAPEUTICS, INC.
Condensed Consolidated Statements of Changes in Stockholders’ Equity
(in thousands, except share data)
(unaudited)
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Accumulated |
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Other |
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Total |
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Common Stock |
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Additional |
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Accumulated |
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Comprehensive |
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Stockholders’ |
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Shares |
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Amount |
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Paid-in Capital |
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Deficit |
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Income/(Loss) |
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Equity |
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Balance, December 31, 2024 |
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$ |
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$ |
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$ |
( |
) |
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$ |
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$ |
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Exercise of pre-funded warrants |
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— |
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— |
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— |
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Exercise of stock options |
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— |
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— |
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— |
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Issuance of common stock under employee stock purchase plan (“ESPP”) |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
Unrealized gain on marketable securities |
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— |
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— |
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— |
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— |
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Balance, March 31, 2025 |
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$ |
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$ |
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$ |
( |
) |
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$ |
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$ |
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Exercise of stock options |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
Unrealized loss on marketable securities |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance, June 30, 2025 |
|
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$ |
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$ |
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$ |
( |
) |
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$ |
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$ |
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Balance, December 31, 2023 |
|
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$ |
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$ |
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$ |
( |
) |
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$ |
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$ |
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Issuance of common stock and pre-funded warrants in |
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— |
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— |
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Exercise of stock options |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
Unrealized loss on marketable securities |
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— |
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— |
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— |
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— |
|
|
|
( |
) |
|
|
( |
) |
Balance, March 31, 2024 |
|
|
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|
$ |
|
|
$ |
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$ |
( |
) |
|
$ |
( |
) |
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$ |
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||||
Exercise of stock options |
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— |
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— |
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— |
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|||
Stock-based compensation expense |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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|
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( |
) |
|
|
— |
|
|
|
( |
) |
Unrealized loss on marketable securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance, June 30, 2024 |
|
|
|
|
$ |
|
|
$ |
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$ |
( |
) |
|
$ |
( |
) |
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$ |
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||||
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
DIANTHUS THERAPEUTICS, INC.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
|
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Six Months Ended |
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2025 |
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2024 |
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Cash flows from operating activities: |
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Net loss |
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$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation expense |
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Stock-based compensation expense |
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Accretion of discount on investment securities |
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( |
) |
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( |
) |
Amortization of right-of-use operating lease assets |
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Gain on investment in former related party |
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( |
) |
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Changes in operating assets and liabilities: |
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Receivable from former related party |
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( |
) |
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Unbilled receivable from former related party |
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( |
) |
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Accounts receivable, net |
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( |
) |
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Prepaid expenses and other current assets |
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( |
) |
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( |
) |
Other assets |
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( |
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Accounts payable, accrued expenses and operating lease liabilities |
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Deferred revenue |
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( |
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Deferred revenue - former related party |
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( |
) |
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Net cash used in operating activities |
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( |
) |
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( |
) |
Cash flows from investing activities: |
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Capital expenditures |
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|
( |
) |
|
|
( |
) |
Purchases of investment securities |
|
|
( |
) |
|
|
( |
) |
Proceeds from maturities of investment securities |
|
|
|
|
|
|
||
Net cash provided by/(used in) investing activities |
|
|
|
|
|
( |
) |
|
Cash flows from financing activities: |
|
|
|
|
|
|
||
Proceeds from issuance of common stock under ESPP |
|
|
|
|
|
|
||
Proceeds from exercise of stock options |
|
|
|
|
|
|
||
Proceeds from exercise of pre-funded warrants |
|
|
|
|
|
|
||
Proceeds from private placement |
|
|
|
|
|
|
||
Payment of issuance costs in connection with private placement |
|
|
|
|
|
( |
) |
|
Net cash provided by financing activities |
|
|
|
|
|
|
||
(Decrease)/increase in cash, cash equivalents and restricted cash |
|
|
( |
) |
|
|
|
|
Cash, cash equivalents and restricted cash, beginning of period |
|
|
|
|
|
|
||
Cash, cash equivalents and restricted cash, end of period |
|
$ |
|
|
$ |
|
||
Supplemental Disclosure |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Restricted cash |
|
|
|
|
|
|
||
Total cash, cash equivalents and restricted cash |
|
$ |
|
|
$ |
|
||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
DIANTHUS THERAPEUTICS, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share and per share data, unless otherwise stated)
1. Organization, Description of Business and Liquidity
Business
Dianthus Therapeutics, Inc. (the “Company” or “Dianthus”) is a clinical-stage biotechnology company focused on developing next-generation complement therapeutics for patients living with severe autoimmune and inflammatory diseases. The Company’s corporate headquarters are in New York, New York.
Currently, the Company is devoting substantially all efforts and resources toward product research and development of its product candidates. The Company has incurred losses from operations and negative operating cash flows since its inception. There can be no assurance that its research and development programs will be successful, that products developed, if any, will obtain necessary regulatory approval, or that any approved product, if any, will be commercially viable. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its key employees, consultants, and advisors.
Reverse Merger and Pre-Closing Financing
On September 11, 2023, the Company completed its business combination with Dianthus Therapeutics OpCo, Inc. (formerly Dianthus Therapeutics, Inc.) (“Former Dianthus”) in accordance with the terms of the Agreement and Plan of Merger, dated as of May 2, 2023 (the “Merger Agreement”), by and among the Company, Dio Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of the Company (“Merger Sub”), and Former Dianthus, pursuant to which, among other matters, Merger Sub merged with and into Former Dianthus, with Former Dianthus surviving as a wholly owned subsidiary of the Company (the “Reverse Merger”). In connection with the completion of the Reverse Merger, the Company changed its name from “Magenta Therapeutics, Inc.” to “Dianthus Therapeutics, Inc.,” and the business conducted by the Company became primarily the business conducted by Former Dianthus. Unless context otherwise requires, references herein to “Dianthus,” the “Company,” or the “combined company” refer to Dianthus Therapeutics, Inc. (formerly Magenta Therapeutics, Inc.) after completion of the Reverse Merger, the term “Former Dianthus” refers to Dianthus Therapeutics OpCo, Inc. (formerly Dianthus Therapeutics, Inc.), and the term “Magenta” refers to the Company prior to completion of the Reverse Merger. The Company was incorporated in June 2015 and Former Dianthus was incorporated in May 2019.
At the effective time of the Reverse Merger, the Company issued an aggregate of
At the effective time of the Reverse Merger, the 2019 Stock Plan (as discussed in Note 11) was assumed by the Company, and each outstanding and unexercised option to purchase shares of Former Dianthus common stock immediately prior to the effective time of the Reverse Merger was assumed by the Company and converted into an option to purchase shares of Company common stock, with necessary adjustments to the number of shares and exercise price to reflect the exchange ratio, and each outstanding and unexercised warrant to purchase shares of Former Dianthus common stock immediately prior to the effective time of the Reverse Merger (including the Former Dianthus pre-funded warrants sold in the pre-closing financing) was converted into a warrant to purchase shares of Company common stock, with necessary adjustments to the number of shares and exercise price to reflect the exchange ratio.
5
The Reverse Merger was accounted for as a reverse recapitalization in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). Under this method of accounting, Former Dianthus was deemed to be the accounting acquirer for financial reporting purposes. This determination was primarily based on the expectation that, immediately following the Reverse Merger: (i) Former Dianthus’ stockholders would own a substantial majority of the voting rights in the combined company; (ii) Former Dianthus’ largest stockholders would retain the largest interest in the combined company; (iii) Former Dianthus designated a majority (six of eight) of the initial members of the board of directors of the combined company; and (iv) Former Dianthus’ executive management team became the management team of the combined company. Accordingly, for accounting purposes: (i) the Reverse Merger was treated as the equivalent of Former Dianthus issuing stock to acquire the net assets of Magenta; (ii) the net assets of Magenta were recorded at their acquisition-date fair value in the unaudited condensed consolidated financial statements of Former Dianthus and (iii) the reported historical operating results of the combined company prior to the Reverse Merger are those of Former Dianthus. Historical common stock figures of Former Dianthus have been retroactively restated based on the exchange ratio of approximately
On September 11, 2023, prior to the effective time of the Reverse Merger, the Company entered into a contingent value rights agreement (the “CVR Agreement”) with a rights agent, pursuant to which pre-Reverse Merger holders of Magenta common stock received one non-transferable contingent value right (each, a “CVR”) for each outstanding share of Magenta common stock held by such stockholder immediately prior to the effective time of the Reverse Merger on September 11, 2023. Subject to, and in accordance with, the terms and conditions of the CVR Agreement, each CVR represents the contractual right to receive a pro rata portion of the proceeds, if any, received by the Company as a result of (i) contingent payments made to the Company, such as milestone, royalty or earnout, when received under any pre-Reverse Merger disposition agreements related to Magenta’s pre-Reverse Merger assets and (ii) the Company’s sale of assets after the effective date of the Reverse Merger and prior to December 31, 2023, in each case, received within a three-year period following the closing of the Reverse Merger.
The Company believes that the achievement of the milestones outlined in the CVR Agreement are highly susceptible to factors outside the Company's influence that are not expected to be resolved for a long period of time, if at all. In particular, these amounts are primarily influenced by the actions and judgments of third parties and the buyers of such assets and are based on the buyers of such assets progressing the in-process research and development assets into clinical trials, and in the case of one of the agreements, to a regulatory milestone. If the Company were to record a receivable for such contingent payments, it would also record a corresponding liability. As of June 30, 2025, no receivables were recorded on the unaudited condensed consolidated balance sheet relating to such contingent payments.
Concurrently with the execution and delivery of the Merger Agreement, and in order to provide Former Dianthus with additional capital for its development programs, Former Dianthus entered into a subscription agreement, as amended (the “Subscription Agreement”), with certain investors named therein (the “Investors”), pursuant to which, subject to the terms and conditions of the Subscription Agreement, immediately prior to the effective time of the Reverse Merger, Former Dianthus issued and sold, and the Investors purchased, (i)
2024 Private Placement
On January 22, 2024, the Company entered into a securities purchase agreement for a private placement with certain institutional and accredited investors. At the closing of the private placement on January 24, 2024, the Company sold and issued
Shelf Registration Statement and ATM Offering Program
On October 1, 2024, the Company filed a registration statement with the Securities and Exchange Commission (the “SEC”) for the issuance of common stock, preferred stock, warrants, debt securities, rights and units up to an aggregate of $
6
Risks and Uncertainties
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry including, but not limited to, uncertainty of product development and commercialization, lack of marketing and sales history, development by its competitors of new technological innovations, dependence on its key personnel, market acceptance of products, product liability, protection of proprietary technology, ability to raise additional financing and compliance with government regulations. If the Company does not successfully commercialize any of its product candidates, it will be unable to generate recurring product revenue or achieve profitability.
The Company’s lead product candidate that is in development and any future product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure, and extensive compliance-reporting capabilities. Even if its product development efforts are successful, it is uncertain when, if ever, the Company will generate revenue from product sales.
Liquidity
In accordance with Accounting Standards Update No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there are certain conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the accompanying unaudited condensed consolidated financial statements were issued (the “issuance date”):
In the event the Company is unable to secure additional outside capital, management will be required to seek other alternatives which may include, among others, a delay or termination of clinical trials or the development of its product candidates, temporary or permanent curtailment of the Company’s operations, a sale of assets, or other alternatives with strategic or financial partners.
2. Summary of Significant Accounting Policies
The Company’s significant accounting policies are disclosed in the audited consolidated financial statements and the notes thereto in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 11, 2025. Except as reflected below, there were no changes to the Company’s significant accounting policies as described in the Annual Report on Form 10-K. Reflected in this note are updates to accounting policies, including the impact of the adoption of new policies.
7
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements as of June 30, 2025 and for the three and six months ended June 30, 2025 and 2024 have been prepared in conformity with U.S. GAAP, for interim financial information and pursuant to Article 10 of Regulation S-X of the Securities Act of 1933, as amended (the “Securities Act”). Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. These unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s audited financial statements and include only normal and recurring adjustments that the Company believes are necessary to fairly state the Company’s financial position and the results of its operations and cash flows. The results for the three and six months ended June 30, 2025 are not necessarily indicative of the results expected for the full fiscal year or any subsequent interim period. The unaudited condensed consolidated balance sheet as of December 31, 2024 has been derived from the audited financial statements at that date but does not include all disclosures required by U.S. GAAP for complete financial statements. Because all of the disclosures required by U.S. GAAP for complete financial statements are not included herein, these unaudited condensed consolidated financial statements and the notes accompanying them should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2024, which are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 11, 2025. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results may differ materially from those estimates.
Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates including the following: expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Significant estimates are used in the following areas, among others: the recognition of research and development expense, stock-based compensation and revenue recognition.
Concentration of Credit Risk
Recently Adopted Accounting Pronouncements
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740), Improvements to Income Tax Disclosures, to enhance the transparency and decision usefulness of income tax disclosures. The enhancement provides information to better assess how an entity’s operations and related tax risks and tax planning and operational opportunities affect its tax rate and prospects for future cash flows. On January 1, 2025, the Company adopted ASU 2023-09. The adoption of this standard did not have a material effect on the Company’s unaudited condensed consolidated financial position, results of operations, or cash flows.
8
Recently Issued Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. The amendments in ASU 2024-03 address investor requests for more detailed expense information and require additional disaggregated disclosures in the notes to financial statements for certain categories of expenses that are included on the face of the income statement. This guidance is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating this guidance to determine the impact it may have on the unaudited condensed consolidated financial statements.
In July 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the United States of America. The OBBBA includes significant provisions, including permanently repealing the requirement to capitalize domestic research and development expenditures for federal income tax purposes for taxable years beginning after December 31, 2024, and allowing for the accelerated deduction of any remaining unamortized domestic research and development expenditures. Foreign research and development expenditures are still required to be capitalized and amortized ratably over 15 years. The Company is currently evaluating this legislation to determine the potential impact it may have on the unaudited condensed consolidated financial statements.
3. Segment Reporting
Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (the “CODM”) in deciding how to allocate resources and in assessing the Company’s performance. The Company operates as a operating segment and has
The Company’s CODM is its . The CODM manages the Company’s operations on a consolidated basis as one operating segment for the purposes of evaluating financial performance and allocating resources.
The Company has not generated any revenue from product sales yet. The CODM assesses the financial performance of the segment and decides how to allocate resources based on net loss on a consolidated basis. The measure of segment assets is reported on the unaudited condensed consolidated balance sheets as total consolidated assets.
All of the Company’s tangible assets are held in the United States. The Company views its operations and manages its business in one operating segment, operating exclusively in the United States.
9
The table below provides a summary of the segment profit or loss, including significant segment expenses:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
License revenue - former related party |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
License revenue |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total revenues |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Claseprubart (DNTH103) program-related expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Clinical operation activity costs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Chemistry, manufacturing and control (“CMC”) activity costs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Preclinical study activity costs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other costs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total claseprubart (DNTH103) program-related expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Personnel and related costs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Discovery expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other costs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total research and development expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Personnel and related costs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other costs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total general and administrative expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other income, net |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
4. Cash Equivalents and Marketable Securities
The Company’s investments consist of marketable securities classified as available-for-sale. The following tables provide a summary of the estimated fair value of the Company’s cash equivalents and marketable securities:
|
|
June 30, 2025 |
|
|
Classification |
|
||||||||||||||||||
|
|
Amortized |
|
|
Gross |
|
|
Gross |
|
|
Fair Value |
|
|
Short-term |
|
|
Long-term |
|
||||||
Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|||||
Total cash equivalents |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
U.S. treasury securities |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
Certificate of deposit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
U.S. government agency securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||||
Corporate debt securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||||
Total marketable securities |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
10
|
|
December 31, 2024 |
|
|
Classification |
|
||||||||||||||||||
|
|
Amortized |
|
|
Gross |
|
|
Gross |
|
|
Fair Value |
|
|
Short-term |
|
|
Long-term |
|
||||||
Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|||||
Corporate debt securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|||||
Total cash equivalents |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
U.S. treasury securities |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
U.S. government agency securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||||
Corporate debt securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||||
Total marketable securities |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
As of June 30, 2025 and December 31, 2024, marketable securities within the corporate debt securities line item includes both commercial paper and corporate debt securities. Commercial paper held at both June 30, 2025 and December 31, 2024 were classified as short-term securities.
Interest and Investment Income
The following table provides a summary of the components of interest and investment income:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Interest income |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Accretion of discount on marketable securities, net |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total interest and investment income |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
5. Prepaid Expenses and Other Current Assets
The following table provides a summary of prepaid expenses and other current assets:
|
|
June 30, |
|
|
December 31, |
|
||
Prepaid materials, supplies and research and development services |
|
$ |
|
|
$ |
|
||
Prepaid subscriptions, software and other administrative services |
|
|
|
|
|
|
||
Prepaid insurance |
|
|
|
|
|
|
||
Other current assets |
|
|
|
|
|
|
||
Prepaid expenses and other current assets |
|
$ |
|
|
$ |
|
||
6. Property and Equipment
The following table provides a summary of property and equipment:
|
|
June 30, |
|
|
December 31, |
|
||
Computer equipment |
|
$ |
|
|
$ |
|
||
Furniture and fixtures |
|
|
|
|
|
|
||
Subtotal |
|
|
|
|
|
|
||
Less: accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Property and equipment, net |
|
$ |
|
|
$ |
|
||
Depreciation expense was $
11
7. Fair Value of Financial Instruments
The following table provides a summary of financial assets measured at fair value on a recurring basis:
|
|
Fair Value at |
|
|
|
|
|
|
|
|
|
|
||||
Description |
|
June 30, |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Recurring Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. treasury securities |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Certificate of deposit |
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— |
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— |
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||
U.S. government agency securities |
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— |
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— |
|
||
Corporate debt securities |
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— |
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|
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— |
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||
Long-term investments: |
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||||
U.S. treasury securities |
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— |
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— |
|
||
U.S. government agency securities |
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— |
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|
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— |
|
||
Corporate debt securities |
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|
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— |
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|
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— |
|
||
Other assets and restricted cash: |
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|
||||
Investment in former related party |
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|
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— |
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— |
|
||
Total assets measured at fair value |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|||
|
|
Fair Value at |
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||||
|
|
December 31, |
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||||
Description |
|
2024 |
|
|
Level 1 |
|
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Level 2 |
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|
Level 3 |
|
||||
Recurring Assets: |
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|
||||
Cash equivalents: |
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|
||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
Corporate debt securities |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Short-term investments: |
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|
|
|
|
|
|
|
|
||||
U.S. treasury securities |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
U.S. government agency securities |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Corporate debt securities |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. treasury securities |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
U.S. government agency securities |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Corporate debt securities |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Other assets and restricted cash: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Investment in former related party |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Total assets measured at fair value |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|||
There were
As of June 30, 2025 and December 31, 2024, marketable securities within the corporate debt securities line item includes both commercial paper and corporate debt securities. Commercial paper held at both June 30, 2025 and December 31, 2024 were classified as short-term securities and classified within Level 2 of the fair value hierarchy.
12
8. Accrued Expenses
The following table provides a summary of accrued expenses:
|
|
June 30, |
|
|
December 31, |
|
||
Accrued external research and development |
|
$ |
|
|
$ |
|
||
Accrued compensation |
|
|
|
|
|
|
||
Accrued professional fees |
|
|
|
|
|
|
||
Other accrued expenses |
|
|
|
|
|
|
||
Accrued expenses |
|
$ |
|
|
$ |
|
||
9. Leases
The following table provides a summary of the components of lease costs and rent:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Operating lease cost |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Variable lease cost |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total operating lease costs |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Cash paid for amounts included in the measurement of operating lease liabilities was $
The Company recorded operating lease costs of $
Maturities of operating lease liabilities as of June 30, 2025, are as follows:
2025 (remaining 6 months) |
|
|
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
Thereafter |
|
|
|
|
Total undiscounted operating lease payments |
|
|
|
|
Less: imputed interest |
|
|
( |
) |
Present value of operating lease liabilities |
|
$ |
|
|
|
|
|
|
|
Balance sheet classification: |
|
|
|
|
Current portion of operating lease liabilities |
|
$ |
|
|
Long-term operating lease liabilities |
|
|
|
|
Total operating lease liabilities |
|
$ |
|
|
The weighted-average remaining term of operating leases was
13
10. Stockholders' Equity
Shelf Registration Statement and ATM Offering Program
On October 1, 2024, the Company filed a registration statement with the SEC for the issuance of common stock, preferred stock, warrants, debt securities, rights and units up to an aggregate of $
Private Placement Offering
At the closing of the private placement on January 24, 2024, the Company issued
Preferred Stock
As of June 30, 2025, the Company was authorized to issue up to
Common Stock
As of June 30, 2025, the Company was authorized to issue up to
Each share of Company common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to receive dividends, as may be declared by the Company’s board of directors, if any.
The Company had the following shares of Company common stock reserved for future issuance as of June 30, 2025 and December 31, 2024:
|
|
June 30, |
|
|
December 31, |
|
||
Issuance of common stock upon exercise of stock options |
|
|
|
|
|
|
||
Equity awards available for grant under stock award plans |
|
|
|
|
|
|
||
Shares available for issuance under the Employee Stock Purchase Plan |
|
|
|
|
|
|
||
Issuance of common stock upon exercise of warrants |
|
|
|
|
|
|
||
Total common stock reserved for future issuance |
|
|
|
|
|
|
||
11. Stock-Based Compensation
2018 Stock Option and Incentive Plan
The Company grants stock-based awards under the Second Amended and Restated Dianthus Therapeutics, Inc. Stock Option and Incentive Plan, which originally became effective on June 19, 2018 as the Magenta Therapeutics, Inc. 2018 Stock Option and Incentive Plan and was amended and restated in September 2023 and renamed the Amended and Restated Dianthus Therapeutics, Inc. Stock Option and Incentive Plan (the “Prior 2018 Incentive Plan”).
14
On May 23, 2024, the Company’s stockholders approved an amendment and restatement of the Prior 2018 Incentive Plan, and it was renamed the Second Amended and Restated Dianthus Therapeutics, Inc. Stock Option and Incentive Plan (the “2018 Amended Plan”) to:
The 2018 Amended Plan provides that the number of shares reserved and available for issuance under the 2018 Amended Plan will automatically increase each January 1 by
Pursuant to the Evergreen Provision, the number of shares reserved for issuance under the 2018 Amended Plan increased by
As of June 30, 2025,
2019 Stock Plan
In July 2019, Former Dianthus’s board of directors adopted, and the Former Dianthus’s stockholders approved, the Dianthus Therapeutics, Inc. 2019 Stock Plan (the “2019 Stock Plan”). In connection with the Reverse Merger, the Company assumed options to purchase shares of Former Dianthus’s common stock that were outstanding under the 2019 Stock Plan immediately prior to the Reverse Merger and such options were converted into options to purchase
2019 Employee Stock Purchase Plan
Employees may elect to participate in the Dianthus Therapeutics, Inc. 2019 Employee Stock Purchase Plan, as amended (the “ESPP”). The purchase price of Company common stock under the ESPP is equal to
15
Inducement Plan
In February 2024, the Company’s board of directors approved the Dianthus Therapeutics, Inc. Equity Inducement Plan (the “Inducement Plan”), which provides for up to
Stock Options
The following table summarizes stock option activity for the six months ended June 30, 2025:
|
|
Number of |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
||||
|
|
|
|
|
|
|
|
(in years) |
|
|
|
|
||||
Balance at January 1, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Options granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Options exercised |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Options forfeited |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Balance at June 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable options at June 30 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Unvested options at June 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
The aggregate intrinsic value of options granted, options exercised and options forfeited represents the difference between (i) the exercise price of the option and (ii) the closing market price of the Company’s common stock on (x) June 30, 2025, (y) the date of exercise, or (z) the date of forfeiture, respectively.
The weighted average grant-date fair value per share of stock options granted during the six months ended June 30, 2025 was $
The table below summarizes the assumptions used to determine the grant-date fair value of stock options issued, presented on a weighted average basis during the three and six months ended June 30, 2025 and 2024:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Risk-free interest rate |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
||||
Expected term (in years) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Expected volatility |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
||||
Expected dividend yield |
|
|
% |
|
|
% |
|
|
% |
|
|
% |
||||
Stock Warrants
In April 2021, Former Dianthus issued
Stock-based Compensation Expense
The following table provides a summary of stock-based compensation expense:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
16
As of June 30, 2025, there was $
12. License Revenues
Zenas BioPharma, Inc.
In September 2020, the Company entered into an Option Agreement (the “Zenas Option”) with Zenas BioPharma, Inc. (formerly Zenas BioPharma Limited) (“Zenas”), formerly considered a related party (See Note 15). Through the Zenas Option, the Company provided Zenas an option to enter into an exclusive license agreement for the development and commercialization of products arising from its research of monoclonal antibody antagonists targeting certain specific complement proteins.
In October 2021, Zenas exercised its option for such clinical candidate under the Zenas Option. Zenas paid the Company a one-time payment of $
In June 2022, pursuant to the Zenas Option, the Company negotiated in good faith a license agreement with Zenas (the “Zenas License Agreement” and, together with the Zenas Option, the “Zenas Agreements”). The Zenas License Agreement provided Zenas with a license in the People’s Republic of China, including Hong Kong, Macau, and Taiwan (“Greater China”) for the development and commercialization of sequences and products under the first antibody sequence. The Company was also obligated to perform certain research and development and CMC services and participated in a joint steering committee (“JSC”).
The consideration under the Zenas Agreements included the following payments by Zenas to the Company: (i) a $
Tenacia Biotechnology (Hong Kong) Co., Limited
On October 21, 2024, Zenas assigned the Zenas Agreements to its affiliated entity, Zenas BioPharma (HK) Limited (“Zenas HK”). After the assignment, the Company entered into a novation agreement (the “Novation Agreement”) with Zenas HK and Tenacia Biotechnology (Hong Kong) Co., Limited (“Tenacia”) and an amendment to the Zenas License Agreement, now with Tenacia (as amended, the “Tenacia License Agreement”), pursuant to which Tenacia replaced Zenas HK as a party to the Zenas Agreements, and certain economic terms under the Zenas License Agreement with respect to cost sharing and development milestones were amended.
Except as otherwise noted below, the terms of the Zenas License Agreement were unchanged when novated by the Novation Agreement and amended by the Tenacia License Agreement.
The consideration under the Tenacia License Agreement, which replaced the consideration of the Zenas License Agreement, related to the first antibody sequence includes the following payments by Tenacia to the Company: (i) a $
Under the Zenas Agreements, Zenas also had the right to exercise an option with respect to a second antibody sequence, which is now held by Tenacia (the “Tenacia Option” and, together with the Tenacia License Agreement, the “Tenacia Agreements”). Pursuant to the Tenacia Option, if Tenacia exercises the option and pays the Company the option exercise fee related to the second antibody sequence, the Company will grant Tenacia an exclusive license to the sequences and products under this second antibody sequence.
17
Accounting for the Zenas and Tenacia Agreements
Since the Zenas Agreements were negotiated with a single commercial objective, it was treated as a combined contract for accounting purposes. The Company assessed the Zenas Agreements in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”), and concluded that it represented a contract with a customer and was within the scope of ASC 606. The Company determined that there was one combined performance obligation that consisted of the license and data transfer, the research and development and CMC services, and the participation in the JSC. The Company determined that Zenas’ right to exercise an option with respect to a second antibody sequence did not represent a material right.
The Company determined that the combined performance obligation would be satisfied over time; therefore, the Company recognized the transaction price from the license agreement over the Company’s estimated period to complete its activities. The Company concluded that it would utilize a cost-based input method to measure its progress toward the completion of its performance obligation and to calculate the corresponding amount of revenue to recognize each period. The Company believed that this was the best measure of progress because other measures did not reflect how the Company transferred its performance obligation to Zenas. In applying the cost-based input method of revenue recognition, the Company used actual costs incurred relative to budgeted costs expected to be incurred for the combined performance obligation. These costs consisted primarily of third-party contract costs. Revenue was recognized based on the level of costs incurred relative to the total budgeted costs for the combined performance obligation. A cost-based input method of revenue recognition required management to make estimates of costs to complete the Company’s performance obligation. In making such estimates, judgment was required to evaluate assumptions related to cost estimates.
The Company assessed the Tenacia Agreements in accordance with ASC 606 and applied the same considerations above to the Tenacia Agreements. With the exception of the cost sharing and development milestones noted below, the key terms of the Zenas License Agreement were unchanged when novated by the Novation Agreement and amended by the Tenacia License Agreement. Therefore, the Company determined that the accounting considerations and resulting conclusions noted above related to the Zenas Agreements also apply to the Tenacia Agreements.
The Company also determined that the milestone payments of $
There is a sales or usage-based royalty exception within ASC 606 that applies when a license of intellectual property is the predominant item to which the royalty relates. In accordance with this royalty exception, the Company will recognize royalty revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). The Company has
The Company recognized related party license revenue totaling
During the three and six months ended June 30, 2025, the Company recognized license revenue totaling $
18
13. Net Loss Per Share
Basic and diluted net loss per share of common stock is calculated as follows:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
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 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share attributable to common stockholders, |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Pre-funded warrants totaling
The Company’s potential dilutive securities, which include stock options and warrants for the purchase of common stock, have been excluded from the computation of diluted net loss per share as the effect would be antidilutive. Therefore, the weighted-average number of shares of common stock outstanding used to calculate both basic and diluted net loss per share is the same.
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Stock options outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrants for the purchase of common stock |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
|
|
|
|
|
|
|
|
|
|
|
||||
14. Commitments and Contingencies
Alloy Therapeutics, LLC
In August 2019, the Company entered into a license agreement with Alloy Therapeutics, LLC (“Alloy”). The license agreement was amended in October 2022. The license agreement with Alloy grants to the Company the following:
19
The Company pays annual license fees and annual partnered antibody program fees totaling $
IONTAS Limited
In July 2020, the Company entered into a collaborative research agreement with IONTAS Limited (“IONTAS”) to perform certain milestone-based research and development activities for the Company under its first development program. This agreement was amended in January 2023 to extend their services to additional development programs. IONTAS provides dedicated resources to perform the research and development activities and receives compensation for those resources as well as success-based milestone payments.
Upon the achievement, with the first development program with IONTAS, of (i) certain development milestones and (ii) certain commercial milestones, the Company is obligated to make additional payments to IONTAS of up to £
Indemnification Agreements
In the ordinary course of business, the Company may provide indemnification of varying scope and terms to employees, consultants, vendors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. To date, the Company has not incurred any material costs as a result of such indemnification agreements. The Company is not aware of any indemnification arrangements that could have a material effect on its financial position, results of operations or cash flows, and has not accrued any liabilities related to such obligations in its unaudited condensed consolidated financial statements as of June 30, 2025 and December 31, 2024.
Litigation
From time to time, the Company may be exposed to litigation relating to potential products and operations. The Company is not currently engaged in any legal proceedings that are expected, individually or in the aggregate, to have a material adverse effect on its financial condition, results of operations or cash flows.
Other
As of June 30, 2025 and December 31, 2024, the Company had standing agreements with consultants, contractors or service providers that generally can be terminated by the Company with 30 to 60 days written notice, unless otherwise indicated.
20
15. Related Party Transactions
Zenas BioPharma, Inc.
The Company previously considered Zenas to be a related party because the sole member of Tellus BioVentures LLC (“Tellus”), who was a significant shareholder in the Company and was a member of the board of directors of the Company until May 2025, is a significant shareholder in Zenas and serves as Chief Executive Officer and Chairman of the board of directors of Zenas. As of May 2025, the Company no longer considers Zenas to be a related party. See Note 12 for more information.
In September 2020, Zenas issued
21
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. This discussion contains forward-looking statements that involve risks and uncertainties, including those described in the section titled “Special Note Regarding Forward-Looking Statements” included elsewhere in this Quarterly Report on Form 10-Q. Our actual results and the timing of selected events could differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those set forth under the section titled “Risk Factors” included elsewhere in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 11, 2025.
Overview
We are a clinical-stage biotechnology company focused on developing next-generation complement therapeutics for patients living with severe autoimmune and inflammatory diseases. We believe our lead novel and proprietary monoclonal antibody product candidate, claseprubart, formerly referred to as DNTH103, has the potential to address a broad array of complement-dependent diseases as currently available therapies and those in development leave room for improvements in efficacy, safety, and/or dosing convenience. We have purposefully engineered claseprubart to selectively bind to only the active form of the C1s complement protein (“C1s”) and to exhibit improved potency and an extended half-life. By selectively targeting only the active form of C1s, which drives disease pathology and constitutes only a small fraction of the total protein present in circulation, we aim to reduce the amount of drug required for a therapeutic effect. We intend to deliver our product candidate through a lower dose, less frequent, self-administered, convenient subcutaneous (“S.C.”) injection suitable for a pre-filled pen.
Our Pipeline-in-a-Product Potential for Claseprubart, a Next-Generation Complement Therapeutic
Our most advanced product candidate, claseprubart, formerly referred to as DNTH103, is a clinical-stage, highly potent, highly selective and fully human monoclonal immunoglobulin G4 with picomolar binding affinity that is designed to selectively bind only to the active form of C1s. The active form of C1s is generated during complement activation by cleavage of the inactive proC1s. As a validated complement target in the autoimmune and inflammatory field, C1s inhibition prevents further progression of the classical pathway cascade. Claseprubart is engineered with YTE half-life extension technology, a specific three amino acid change in the Fc domain, and has a pharmacokinetic (“PK”) profile designed to support less frequent, lower dose, self-administration as a convenient S.C. injection. We are currently conducting three mid- to late-stage clinical trials with claseprubart in generalized Myasthenia Gravis (“gMG”), Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”), and Multifocal Motor Neuropathy (“MMN”).
MAGIC
The MaGic trial is a global, randomized, double-blind, placebo-controlled Phase 2 study of claseprubart in up to 60 patients with gMG who are acetylcholine receptor antibody positive. Following an initial loading dose, claseprubart will be administered every two weeks (“Q2W”) via S.C. injection. The S.C. treatment duration will initially be 12 weeks with a 52-week open label extension. The primary endpoint of the study is safety and tolerability. Secondary endpoints include Myasthenia Gravis Activities of Daily Living Scale (“MG-ADL”) and Quantitative Myasthenia Gravis (“QMG”) score assessments. We announced the completion of enrollment of the MaGiC trial in May 2025 with 65 patients, exceeding our initial target of 60 patients, and top-line results are expected in September 2025.
CAPTIVATE
The CAPTIVATE trial is a single, two-part, randomized withdrawal global Phase 3 trial of claseprubart in patients with CIDP. In the open label Part A of this trial, participants will be administered with a loading dose followed by 300mg claseprubart administered Q2W via S.C. injection for up to 13 weeks. Part A includes an interim responder analysis of the first 40 participants enrolled in Part A. Only participants who respond to claseprubart in Part A, as measured as greater than or equal to one point decrease (improvement) in adjusted Inflammatory Neuropathy Cause and Treatment (“INCAT”) disability score compared to Part A baseline, will be randomized into Part B, a double-blind, placebo-controlled treatment period of up to 52 weeks, where they will be assessed for prevention of relapse, safety and tolerability, followed by an open-label extension period. We believe that this single pivotal trial will support a Biologics License Application (“BLA”) filing in adult patients with CIDP. We anticipate completing an interim responder analysis of the first 40 participants in Part A in the second half of 2026.
22
MOMENTUM
The MoMeNtum trial is a global, randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the safety, tolerability, and efficacy of claseprubart in 36 patients with MMN. Following determination of Ig dependency and responsiveness, patients will be randomized to receive placebo or claseprubart administered Q2W via S.C. injection. The initial S.C. treatment duration is expected to be 17 weeks followed by a 52-week open label extension. The primary endpoint of this study is safety and tolerability. Secondary endpoints include time to intravenous immunoglobulin (“IVIg”) retreatment, time to relapse, and assessments of muscle and grip strength. We anticipate initial top-line results from this trial to be available in the second half of 2026.
Global and Macroeconomic Developments
Uncertainty in the global economy presents significant risks to our business. We are subject to continuing risks and uncertainties in connection with legislative, regulatory, political, geopolitical and macroeconomic developments beyond our control, including inflationary pressures, general economic slowdown or a recession, high interest rates, changes in monetary policy or foreign currency exchange rates, changes in trade policies, including tariffs and other trade restrictions or the threat of such actions, instability in financial institutions, the ongoing conflict in Ukraine, conflicts in the Middle East, rising tensions between China and Taiwan, the attacks on marine vessels traversing the Red Sea and the responses thereto, and supply chain disruptions. While we are closely monitoring the impact of the current macroeconomic conditions on all aspects of our business, including the impacts on participants in our clinical trials, employees, suppliers, vendors, business partners and regulators, the ultimate extent of the impact on our business remains highly uncertain and will depend on future developments and factors that continue to evolve. Most of these developments and factors are outside of our control and could exist for an extended period of time. We will continue to evaluate the nature and extent of the potential impacts to Dianthus’ business, results of operations, liquidity and capital resources. For additional information, see the section titled “Risk Factors” found elsewhere in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 11, 2025.
Components of Results of Operations
Revenues
Since inception, we have not generated any revenue from product sales, and we do not expect to generate any revenue from the sales of products in the foreseeable future. We have recognized revenues attributable to upfront payments, milestone payments and cost reimbursements under our license agreements.
If our development efforts for claseprubart, or any future product candidates, if any, are successful and result in regulatory approval, we may generate revenue from future product sales. If we enter into license or collaboration agreements for claseprubart, or any future product candidates, if any, or intellectual property, revenue may be generated in the future from such license or collaboration agreements. We cannot predict if, when, or to what extent we will generate revenue from the commercialization and sale of claseprubart or any future product candidates or from license or collaboration agreements. We may never succeed in obtaining regulatory approval for claseprubart or any future product candidates.
Licensing Agreements
In June 2022, we executed a license agreement with Zenas BioPharma, Inc. (formerly Zenas BioPharma Limited) (“Zenas”), formerly considered a related party, which provided Zenas with a license in the People’s Republic of China, including Hong Kong, Macau, and Taiwan (“Greater China”) for the development and commercialization of certain sequences and products under an identified antibody sequence (the “Zenas License Agreement”). The Zenas License Agreement included the following payments from Zenas: (i) a non-refundable upfront payment of $1.0 million; (ii) an approximately $1.1 million reimbursement payment for a portion of development costs previously incurred by us; (iii) reimbursement of a portion of all CMC-related costs and expenses for the first antibody sequence through the manufacture of the first two batches of drug product; (iv) reimbursement of a portion of all non-CMC-related costs and expenses for the development of the first antibody sequence through the first regulatory approval; (v) development milestones totaling up to $11.0 million; and (vi) royalties on net sales ranging from the mid-single digits to the low teen percentages.
23
On October 21, 2024, Zenas assigned the Zenas License Agreement to its affiliated entity, Zenas BioPharma (HK) Limited (“Zenas HK”). After the assignment, we entered into a novation agreement (the “Novation Agreement”) with Zenas HK and Tenacia Biotechnology (Hong Kong) Co., Limited (“Tenacia”) and an amendment to the Zenas License Agreement, now with Tenacia (as amended, the “Tenacia License Agreement”), pursuant to which Tenacia replaced Zenas HK as a party to the Zenas Agreements and certain economic terms under the Zenas License Agreement with respect to cost sharing and development milestones were amended.
Except as stated otherwise, the economic terms of the Zenas License Agreement were unchanged when novated by the Novation Agreement and amended by the Tenacia License Agreement.
The consideration under the Tenacia License Agreement, which replaced the consideration of the Zenas License Agreement, related to the first antibody sequence includes the following payments by Tenacia to us: (i) a $2.5 million upfront payment, which was paid by Tenacia to us in October 2024 upon execution of the Tenacia License Agreement; (ii) reimbursement of a portion of certain clinical costs; (iii) development milestones totaling up to $15.0 million; and (iv) royalties on net sales ranging from the mid-single digits to the low teen percentages. Tenacia is also responsible for paying local development costs in Greater China and a portion of central development costs based on the number of patients enrolled from China in our global Phase 3 studies. No milestones were achieved under the Zenas Agreements prior to novation. During the six months ended June 30, 2025, we recognized revenue of $1.0 million related to milestones achieved under the Tenacia Agreements (as defined below). We have not recorded any royalty revenue under the Zenas Agreement prior to novation or the Tenacia Agreements.
Under the Zenas License Agreement, Zenas also had the right to exercise an option with respect to a second antibody sequence, which is now held by Tenacia (the “Tenacia Option” and, together with the Tenacia License Agreement, the “Tenacia Agreements”). Pursuant to the Tenacia Option, if Tenacia exercises the option and pays us the option exercise fee related to the second antibody sequence, we will grant Tenacia an exclusive license to the sequences and licensed products under this second antibody sequence. The economic terms with respect to this second antibody sequence were unchanged by the amendment to the Zenas License Agreement.
We recognized related party license revenue totaling nil during each of the three and six months ended June 30, 2025, and $1.9 million and $2.7 million during the three and six months ended June 30, 2024, respectively, associated with the Zenas Agreements.
During the three and six months ended June 30, 2025, we recognized license revenue totaling $0.2 million and $1.4 million, respectively, related to the Tenacia Agreements.
Operating Expenses
Research and Development
Research and development expenses account for a significant portion of our operating expenses and consist primarily of external and internal expenses incurred in connection with the discovery and development of claseprubart and other potential product candidates.
External expenses include:
Internal expenses include:
24
We recognize research and development expenses in the periods in which they are incurred. Our internal resources, employees and infrastructure are not directly tied to any one research or drug discovery program and are typically deployed across multiple programs. External expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers or our estimate of the level of service that has been performed at each reporting date. We utilize CROs for research and development activities and CDMOs for manufacturing activities and we do not have laboratory or manufacturing facilities. Therefore, we have no material facilities expenses attributed to research and development.
Product candidates in later stages of development generally have higher development costs than those in earlier stages. As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance claseprubart into larger and later-stage clinical trials, work to discover and develop additional product candidates, seek to expand, maintain, protect and enforce our intellectual property portfolio and hire additional research and development personnel.
The successful development of claseprubart or any future product candidates is highly uncertain, and we do not believe it is possible at this time to accurately project the nature, timing and estimated costs of the efforts necessary to complete the development of, and obtain regulatory approval for, claseprubart or any future product candidates. To the extent claseprubart or any future product candidates continue to advance into larger and later-stage clinical trials, our expenses will increase substantially and may become more variable. The duration, costs and timing of development of claseprubart or any future product candidates are subject to numerous uncertainties and will depend on a variety of factors, including:
25
Any of these factors could significantly impact the costs, timing and viability associated with the development of claseprubart or any future product candidates.
General and Administrative Expenses
General and administrative expenses primarily consist of salaries, bonuses, related benefits, and stock-based compensation expense for personnel in executive, finance, and administrative functions; professional fees for legal, consulting, accounting, and audit services; and travel expenses, technology costs and other allocated expenses. General and administrative expenses also include corporate facility costs, including insurance, rent, utilities, depreciation, and maintenance, not otherwise included in research and development expenses. We recognize general and administrative expenses in the periods in which they are incurred.
We expect that our general and administrative expenses will increase in the future to support our continued research and development activities, pre-commercial preparation activities for the product candidates and, if any product candidate receives marketing approval, commercialization activities. In addition, we anticipate that we will incur additional expenses associated with being a public company, including expenses related to accounting, audit, legal, regulatory, public company reporting and compliance, director and officer insurance, investor and public relations, and other administrative and professional services.
Other Income/(Expense)
Other income/(expense) consists primarily of interest income generated from earnings on invested cash equivalents and investment securities.
Income Tax
Since inception, we have not recorded any U.S. federal or state income tax benefits for the net losses we have incurred in each year or for our earned research tax credits due to uncertainty of realizing a benefit from those items. We maintain a full valuation allowance on our federal and state deferred tax assets as we have concluded that it is more likely than not that the deferred assets will not be utilized.
26
Results of Operations
Comparison of the Three Months Ended June 30, 2025 and 2024
The following table summarizes our results of operations and other comprehensive loss for the periods indicated:
|
Three Months Ended |
|
|||||
|
2025 |
|
|
2024 |
|
||
|
(in thousands) |
|
|||||
Revenues: |
|
|
|
|
|
||
License revenue - former related party |
$ |
— |
|
|
$ |
1,863 |
|
License revenue |
|
193 |
|
|
|
— |
|
Total revenues |
|
193 |
|
|
|
1,863 |
|
Operating expenses: |
|
|
|
|
|
||
Research and development |
|
26,251 |
|
|
|
18,070 |
|
General and administrative |
|
8,869 |
|
|
|
5,997 |
|
Total operating expenses |
|
35,120 |
|
|
|
24,067 |
|
Loss from operations |
|
(34,927 |
) |
|
|
(22,204 |
) |
Other income/(expense): |
|
|
|
|
|
||
Interest and investment income |
|
3,403 |
|
|
|
4,708 |
|
Gain on investment in former related party |
|
32 |
|
|
|
— |
|
Loss on currency exchange, net |
|
(30 |
) |
|
|
(31 |
) |
Other expense |
|
(107 |
) |
|
|
(80 |
) |
Total other income |
|
3,298 |
|
|
|
4,597 |
|
Net loss |
$ |
(31,629 |
) |
|
$ |
(17,607 |
) |
Revenues
Under the terms of the Zenas Agreements, we recognized related party license revenue of nil and $1.9 million during the three months ended June 30, 2025 and 2024, respectively. Additionally, under the terms of the Tenacia Agreements, we recognized license revenue of $0.2 million and nil for the three months ended June 30, 2025 and 2024, respectively.
The decrease in total revenues was due to a decrease of $1.7 million in reimbursable costs associated with claseprubart’s ongoing clinical trials.
Research and Development Expenses
Research and development expenses were $26.3 million for the three months ended June 30, 2025, as compared to $18.1 million for the three months ended June 30, 2024, an increase of $8.2 million. This increase was due to: (1) a $4.8 million increase in external research and development costs, consisting of clinical operations activities, CMC activities, preclinical study costs, discovery expenses and other costs related to claseprubart; and (2) a $3.4 million increase in internal research and development costs, consisting of personnel and related costs, stock-based compensation expense and other costs.
The $4.8 million increase in external research and development costs was due to a $5.1 million increase in expenses related to our lead product candidate, claseprubart, partially offset by a $0.3 million decrease in discovery activities. For the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, the increase in claseprubart related expense was due to $7.8 million in clinical operations activities and $0.4 million in CMC activities, partially offset by decreases of $2.6 million in preclinical study costs and $0.5 million in other costs related to claseprubart. The increased costs of clinical operations activities and CMC activities were due to activities related to claseprubart’s ongoing Phase 2 clinical trials in gMG and MMN and Phase 3 clinical trial in CIDP.
The $3.4 million increase in internal research and development costs was due to increases of $2.3 million in personnel and related costs and $1.1 million in stock-based compensation expense. The increase in costs was primarily due to increases in headcount and related expenses to support our ongoing Phase 2 and Phase 3 clinical trials.
27
General and Administrative Expenses
General and administrative expenses were $8.9 million for the three months ended June 30, 2025, as compared to $6.0 million for the three months ended June 30, 2024, an increase of $2.9 million. The increase was primarily due to increases of $1.5 million in stock-based compensation expense, $0.8 million in personnel-related costs and $0.6 million in other costs. The increase in costs was primarily due to increases in headcount and related expenses to support our ongoing Phase 2 and Phase 3 clinical trials.
Other Income/(Expense)
Other income was $3.3 million for the three months ended June 30, 2025, as compared to $4.6 million for the three months ended June 30, 2024, a decrease of $1.3 million. The decrease was primarily due to higher cash and investment balances in the prior comparable period.
Comparison of the Six Months Ended June 30, 2025 and 2024
The following table summarizes our results of operations and other comprehensive loss for the periods indicated:
|
Six Months Ended |
|
|||||
|
2025 |
|
|
2024 |
|
||
|
(in thousands) |
|
|||||
Revenues: |
|
|
|
|
|
||
License revenue - former related party |
$ |
— |
|
|
$ |
2,737 |
|
License revenue |
|
1,356 |
|
|
|
— |
|
Total revenues |
|
1,356 |
|
|
|
2,737 |
|
Operating expenses: |
|
|
|
|
|
||
Research and development |
|
53,254 |
|
|
|
31,148 |
|
General and administrative |
|
16,206 |
|
|
|
11,637 |
|
Total operating expenses |
|
69,460 |
|
|
|
42,785 |
|
Loss from operations |
|
(68,104 |
) |
|
|
(40,048 |
) |
Other income/(expense): |
|
|
|
|
|
||
Interest and investment income |
|
7,194 |
|
|
|
8,930 |
|
Gain on investment in former related party |
|
27 |
|
|
|
— |
|
Loss on currency exchange, net |
|
(52 |
) |
|
|
(43 |
) |
Other expense |
|
(205 |
) |
|
|
(194 |
) |
Total other income |
|
6,964 |
|
|
|
8,693 |
|
Net loss |
$ |
(61,140 |
) |
|
$ |
(31,355 |
) |
Revenues
Under the terms of the Zenas Agreements, we recognized related party license revenue of nil and $2.7 million during the six months ended June 30, 2025 and 2024, respectively. Additionally, under the terms of the Tenacia Agreements, we recognized license revenue of $1.4 million and nil for the six months ended June 30, 2025 and 2024, respectively.
The decrease in total revenues was due to a decrease of $1.3 million in reimbursable costs associated with claseprubart’s ongoing clinical trials.
Research and Development Expenses
Research and development expenses were $53.3 million for the six months ended June 30, 2025, as compared to $31.2 million for the six months ended June 30, 2024, an increase of $22.1 million. This increase was due to: (1) a $14.6 million increase in external research and development costs, consisting of clinical operations activities, CMC activities, preclinical study costs, discovery expenses and other costs related to claseprubart; and (2) a $7.5 million increase in internal research and development costs, consisting of personnel and related costs, stock-based compensation expense and other costs.
28
The $14.6 million increase in external research and development costs was due to a $14.5 million increase in expenses related to our lead product candidate, claseprubart, and a $0.1 million increase in discovery activities. For the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, the increase in claseprubart related expense was due to increases of $16.3 million in clinical operations activities and $1.4 million in CMC activities, partially offset by decreases of $2.6 million in preclinical study costs and $0.5 million in other costs related to claseprubart. The increased costs of clinical operations activities and CMC activities were due to activities related to claseprubart’s ongoing Phase 2 clinical trials in gMG and MMN and Phase 3 clinical trial in CIDP.
The $7.5 million increase in internal research and development costs was due to increases of $4.4 million in personnel and related costs, $2.7 million in stock-based compensation expense and $0.4 million in other expenses. The increase in costs was primarily due to increases in headcount and related expenses to support our ongoing Phase 2 and Phase 3 clinical trials.
General and Administrative Expenses
General and administrative expenses were $16.2 million for the six months ended June 30, 2025, as compared to $11.6 million for the six months ended June 30, 2024, an increase of $4.6 million. The increase was primarily due to increases of $3.1 million in stock-based compensation expense and $1.5 million in personnel-related costs. The increase in costs was primarily due to increases in headcount and related expenses to support our ongoing Phase 2 and Phase 3 clinical trials.
Other Income/(Expense)
Other income was $7.0 million for the six months ended June 30, 2025, as compared to $8.7 million for the six months ended June 30, 2024, a decrease of $1.7 million. The decrease was primarily due to higher cash and investment balances in the prior comparable period.
Liquidity and Capital Resources
Sources of Liquidity
Since inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from operations. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our lead product candidate, claseprubart, formerly referred to as DNTH103, or any future product candidates. We expect that our research and development and general and administrative costs will continue to increase significantly, including in connection with conducting clinical trials and manufacturing for our lead product candidate or any future product candidates to support potential future commercialization and providing general and administrative support for our operations, including the costs associated with operating as a public company. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements or other sources. See the section titled “Risk Factors” found elsewhere in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 11, 2025 for additional risks associated with our substantial capital requirements.
We have an open market sales agreement with TD Securities (USA) LLC (“TD Cowen”) (the “ATM Agreement”) pursuant to which we may sell, from time to time through TD Cowen, shares of our common stock under an at-the-market (“ATM”) offering for an aggregate sales price of up to $200 million. Any sales of our common stock pursuant to the ATM Agreement are made under our registration statement on Form S-3 which was deemed effective by the SEC on October 9, 2024. To date, we have sold 1,503,708 shares of our common stock under the ATM offering program, with $160.8 million in remaining capacity under the ATM offering program.
To date, we have funded our operations primarily through private placements of capital stock for gross proceeds of $423.5 million and net proceeds of $39.2 million from our ATM offering program.
Future Capital Requirements
Since inception, we have devoted substantially all of our resources to conducting research and development activities (including with respect to the claseprubart program) and undertaking preclinical studies, conducting clinical trials and the manufacturing of the product used in our clinical trials and preclinical studies, business planning, developing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these activities.
29
We do not own or operate, and currently have no plans to establish, any significant laboratory or manufacturing facilities. We rely, and expect to continue to rely, on third parties for the testing and manufacture of our product candidates, as well as for commercial manufacturing should any of our product candidates obtain marketing approval. We believe this strategy allows us to maintain a more efficient infrastructure by eliminating the need to invest in our own significant laboratory and manufacturing facilities, equipment, and personnel while also enabling us to focus expertise and resources on the development of our product candidates.
We have not generated any revenue from product sales. We do not expect to generate any meaningful product revenue unless and until we obtain regulatory approval of and commercialize claseprubart or any future product candidates, and we do not know when, or if, that will occur. In order to complete the development of claseprubart or any future product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize product candidates, if approved, we will require substantial additional capital. Accordingly, until such time that we can generate a sufficient amount of revenue from product sales or other sources, if ever, we expect to seek to raise any necessary additional capital through private or public equity or debt financings, loans or other capital sources, which could include income from collaborations, partnerships or other marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. To the extent that we raise additional capital through equity financings, such as our ATM offering program, or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, including restricting our operations and limiting our ability to incur liens, issue additional debt, pay dividends, repurchase our common stock, make certain investments or engage in merger, consolidation, licensing, or asset sale transactions. If we raise capital through collaborations, partnerships, and other similar arrangements with third parties, we may be required to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. We may be unable to raise additional capital from these sources on favorable terms, or at all. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from bank failures, other general macroeconomic conditions and otherwise. Our failure to obtain sufficient capital on acceptable terms when needed could have a material adverse effect on our business, results of operations or financial condition, including requiring us to seek other alternatives which may include, among others, a delay or termination of our clinical trials or the development of our product candidates, temporary or permanent curtailment of our operations, a sale of our assets, or other alternatives with strategic or financial partners. We cannot provide assurance that we will ever generate positive cash flow from operating activities.
To date, we have funded our operations primarily with proceeds from the sale of capital stock and have raised aggregate gross proceeds of $423.5 million from private placements and net proceeds of $39.2 million from our ATM offering program. However, we have incurred significant recurring losses. We generated net losses of $61.1 million and $31.4 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $235.5 million. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on a variety of factors, including the timing, scope and results of our research and development activities. As of June 30, 2025, we had cash, cash equivalents and investments of $309.1 million. Based on our current operating plan, we believe that our existing cash, cash equivalents and investments should be sufficient to fund our operations into the second half of 2027. Until we achieve profitability, we plan to fund our operations and capital expenditures with cash on hand and expect to seek to raise any necessary additional capital through private or public equity or debt financings, loans or other capital sources, which could include income from collaborations, partnerships or other marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. There can be no assurance that we will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to us.
We based projections of operating capital requirements on our current operating plan, which includes several assumptions that may prove to be incorrect, and we may use all of our available capital resources sooner than we expect.
Because of the numerous risks and uncertainties associated with research, development and commercialization of product candidates, we are unable to estimate the exact amount and timing of our capital requirements. Our future funding requirements will depend on many factors, including:
30
A change in the outcome of any of these or other factors with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, our operating plans may change in the future, and we may need additional capital to meet the capital requirements associated with such operating plans.
Cash Flows
The following table summarizes our cash flows for the periods indicated:
|
Six Months Ended |
|
|||||
|
2025 |
|
|
2024 |
|
||
|
(in thousands) |
|
|||||
Net cash used in operating activities |
$ |
(51,522 |
) |
|
$ |
(29,469 |
) |
Net cash provided by/(used in) investing activities |
|
41,239 |
|
|
|
(4,338 |
) |
Net cash provided by financing activities |
|
729 |
|
|
|
215,651 |
|
(Decrease)/increase in cash, cash equivalents and restricted cash |
$ |
(9,554 |
) |
|
$ |
181,844 |
|
Cash Flows from Operating Activities
For the six months ended June 30, 2025, net cash used in operating activities consisted of a net loss of $61.1 million, partially offset by a decrease in net operating assets and liabilities of $1.4 million and net non-cash operating expenses of $8.2 million. The decrease in net operating assets and liabilities was attributable to an increase in accounts payable, accrued expenses and operating lease liabilities of $1.6 million and decreases in a receivable from Zenas of $0.8 million and other assets of $0.5 million, partially offset by an increase in prepaid expenses and other current assets of $1.3 million and accounts receivable of $0.1 million and a decrease in deferred revenue of $0.1 million. The non-cash operating expenses consisted of stock-based compensation expense of $11.0 million and amortization of right-of-use operating lease assets of $0.2 million, partially offset by accretion of discount on investment securities of $3.0 million.
For the six months ended June 30, 2024, net cash used in operating activities consisted of a net loss of $31.4 million and an increase in net operating assets and liabilities of $2.5 million, partially offset by net non-cash operating expenses of $4.4 million. The increase in net operating assets and liabilities was primarily attributable to increases in other assets of $1.5 million, unbilled receivable from Zenas of $0.6 million, receivable from Zenas of $0.5 million and prepaid expenses and other current assets of $0.1 million, partially offset by an increase in accounts payable, accrued expenses and operating lease liabilities of $0.2 million. The non-cash operating expenses consisted mainly of stock-based compensation expense of $5.1 million and amortization of right-of-use operating lease assets of $0.2 million, partially offset by accretion of discount on investment securities of $0.9 million.
31
Cash Flows from Investing Activities
For the six months ended June 30, 2025, net cash provided by investing activities consisted primarily of $141.7 million in proceeds from maturities of investment securities, partially offset by $100.4 million of purchases of investment securities.
For the six months ended June 30, 2024, net cash used in investing activities consisted primarily of $27.3 million of purchases of investment securities, partially offset by $23.0 million of proceeds from maturities of investment securities.
Cash Flows from Financing Activities
For the six months ended June 30, 2025, net cash provided by financing activities consisted primarily of $0.6 million of proceeds from the exercise of stock options and $0.1 million of proceeds from common stock issued under our ESPP.
For the six months ended June 30, 2024, net cash provided by financing activities consisted of $215.3 million of net proceeds from the private placement and $0.3 million of proceeds from the exercise of stock options.
Contractual Obligations and Commitments
Lease Obligations
We lease administrative office space under operating lease agreements in New York, New York, and Waltham, Massachusetts, which expire in February 2031 and January 2026, respectively.
Research and Development and Manufacturing Agreements
We enter into agreements with certain vendors for the provision of goods and services, which includes manufacturing services with CDMOs and development and clinical trial services with CROs. These agreements may include certain provisions for purchase obligations and termination obligations that could require payments for the cancellation of committed purchase obligations or for early termination of the agreements. The amount of the cancellation or termination payments vary and are based on the timing of the cancellation or termination and the specific terms of the agreement. These obligations and commitments are not presented separately.
License and Collaboration Agreements
In August 2019, we entered into a license agreement with Alloy Therapeutics, LLC (“Alloy”) for (i) a worldwide, non-exclusive license to use the Alloy technology solely to generate Alloy antibodies and platform assisted antibodies for internal, non-clinical research purposes, and (ii) with respect to Alloy antibodies and platform assisted antibodies that are selected by us for inclusion into a partnered antibody program, a worldwide, assignable license to make, have made, use, offer for sale, sell, import, develop, manufacture, and commercialize products comprising partnered antibody programs selected from Alloy antibodies and platform assisted antibodies in any field of use. In addition to annual license fees, we are obligated to pay development and commercial milestone payments of up to $12.8 million for the first partnered antibody, which has been selected for the claseprubart program. The license agreement was amended in October 2022 to extend the agreement to a potential second partnered antibody. In addition to annual license fees, we are obligated to pay development and commercial milestone payments of up to $18.1 million for a second partnered antibody, if and when selected.
In July 2020, we entered into a collaborative research agreement with IONTAS Limited (“IONTAS”) to perform certain milestone-based research and development activities under our first development program. The agreement was amended in January 2023 to extend services to additional development programs. We are obligated to pay development and commercial milestone payments of up to £5.4 million (approximately $7.4 million based on the June 30, 2025 exchange rate) with the first development program and of up to £2.5 million (approximately $3.4 million based on the June 30, 2025 exchange rate) with the second development program.
32
Critical Accounting Policies and Estimates
Our financial statements are prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). The preparation of the financial statements and related disclosures requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate estimates and assumptions on a periodic basis. Our actual results may differ materially from these estimates.
During the six months ended June 30, 2025, there were no material changes to our critical accounting estimates from those disclosed in the audited consolidated financial statements for the year ended December 31, 2024 included in our Annual Report on Form 10-K filed with the SEC on March 11, 2025.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are a smaller reporting company, as defined by Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and in Item 10(f)(1) of Regulation S-K, and are not required to provide the information under this item.
Item 4. Controls and Procedures.
Management’s Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints, and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs. Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2025. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting during the quarter ended June 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may be involved in litigation and other legal proceedings arising in the ordinary course of our business. We are not currently a party to or aware of any legal proceedings that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition, results of operations or cash flows. The outcome of any claims or litigation, regardless of the merits, is inherently uncertain. Regardless of the outcome, litigation and other legal proceedings can have a material adverse impact on us, our business, financial condition, results of operations or cash flows because of defense and settlement costs, diversion of management resources, in the case of intellectual property claims, requirements to change our product candidates, change our business practices, pay monetary damages or enter into short- or long-term royalty or licensing agreements, and other factors.
Item 1A. Risk Factors.
You should carefully consider the risks, uncertainties and other factors contained in the risks factors disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024, as well as the other information in this Quarterly Report on Form 10-Q, including our unaudited condensed consolidated financial statements and related notes and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and in our other public filings, in evaluating our business. The occurrence of any of the events or developments described in the above-mentioned risk factors could materially harm our business, financial condition, results of operations and growth prospects. In such an event, the market price of our common stock could decline. Additional risks, uncertainties and other factors not presently known to us or that we currently deem immaterial also may harm our business, financial condition, results of operations and growth prospects.
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Recent Sales of Unregistered Equity Securities
There were no sales of unregistered equity securities during the quarter ended June 30, 2025.
Issuer Purchases of Equity Securities
We did not repurchase any of our equity securities during the quarter ended June 30, 2025.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
(c) Trading Plans. During the quarter ended June 30, 2025, no director or Section 16 officer
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Item 6. Exhibits.
Exhibit Number |
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Description |
2.1†** |
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3.1** |
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3.2** |
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4.1** |
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4.2** |
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31.1* |
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Principal Executive Officer Certification Pursuant to Rules 13a-14(a) or 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
31.2* |
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32.1*** |
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101.INS |
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Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
101.SCH |
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Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Documents. |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
* Filed herewith.
** Previously filed.
*** Furnished herewith. The certifications on Exhibit 32.1 hereto are deemed not “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section. Such certifications will not be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
† The annexes, schedules and certain exhibits to the Merger Agreement have been omitted pursuant to Item 601(b)(2) of Regulation S-K. Dianthus Therapeutics, Inc. hereby agrees to furnish supplementally a copy of any omitted annex, schedule or exhibit to the SEC upon request.
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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 thereunto duly authorized.
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DIANTHUS THERAPEUTICS, INC. |
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Date: August 7, 2025 |
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By: |
/s/ Marino Garcia |
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Name: Marino Garcia |
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Title: President and Chief Executive Officer (Principal Executive Officer) |
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DIANTHUS THERAPEUTICS, INC. |
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Date: August 7, 2025 |
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By: |
/s/ Ryan Savitz |
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Name: Ryan Savitz |
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Title: Chief Financial Officer and Chief Business Officer (Principal Financial Officer) |
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Exhibit 31.1
PRINCIPAL EXECUTIVE OFFICER CERTIFICATION PURSUANT TO RULES 13a-14(a) OR 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302
OF THE SARBANES-OXLEY ACT OF 2002
I, Marino Garcia, certify that:
Date: |
August 7, 2025 |
By: |
/s/ Marino Garcia |
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Marino Garcia |
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President and Chief Executive Officer |
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(Principal Executive Officer) |
Exhibit 31.2
PRINCIPAL FINANCIAL OFFICER CERTIFICATION PURSUANT TO RULES 13a-14(a) OR 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302
OF THE SARBANES-OXLEY ACT OF 2002
I, Ryan Savitz, certify that:
Date: |
August 7, 2025 |
By: |
/s/ Ryan Savitz |
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Ryan Savitz |
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Chief Financial Officer and Chief Business Officer |
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(Principal Financial Officer) |
Exhibit 32.1
CERTIFICATIONS PURSUANT TO 18 U.S.C.
SECTION 1350 AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Dianthus Therapeutics, Inc. (the “Company”) on Form 10-Q for the three months ended June 30, 2025 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), we, Marino Garcia, President and Chief Executive Officer of the Company, and Ryan Savitz, Chief Financial Officer and Chief Business Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to our knowledge:
Date: |
August 7, 2025 |
By: |
/s/ Marino Garcia |
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Marino Garcia |
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President and Chief Executive Officer |
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(Principal Executive Officer) |
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Date: |
August 7, 2025 |
By: |
/s/ Ryan Savitz |
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Ryan Savitz |
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Chief Financial Officer and Chief Business Officer |
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(Principal Financial Officer) |