|
|
Prospectus Supplement No. 3 (to prospectus dated March 27, 2024) |
Filed pursuant to Rule 424(b)(3) Registration No. 333-274863 |
DIANTHUS THERAPEUTICS, INC.
21,326,988 Shares
Common Stock
Offered by the Selling Stockholders
_________________________________________________________________
This prospectus supplement no. 3 is being filed to update and supplement information contained in the prospectus dated March 27, 2024 (the “Prospectus”) related to the offering on a resale basis by the selling stockholders identified in the Prospectus (the “Selling Stockholders”) of up to 21,326,988 shares of our common stock, par value $0.001 per share (“Common Stock”), with the information contained in our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2024 filed with the Securities and Exchange Commission (the “SEC”) on August 8, 2024 (the “Report”). Accordingly, we have attached the Report to this prospectus supplement. Any document, exhibit or information contained in the Report that has been deemed furnished and not filed in accordance with SEC rules shall not be included in this prospectus supplement.
This prospectus supplement updates and supplements the information in the Prospectus and is not complete without, and may not be delivered or utilized except in combination with, the Prospectus, including any amendments or supplements thereto. This prospectus supplement should be read in conjunction with the Prospectus and if there is any inconsistency between the information therein and this prospectus supplement, you should rely on the information in this prospectus supplement.
Our Common Stock is traded on The Nasdaq Capital Market under the symbol “DNTH.” On August 6, 2024, the last reported sales price for our Common Stock was $28.23 per share.
_________________________________________________________________
An investment in our securities involves a high degree of risk. You should carefully consider the information under the heading “Risk Factors” beginning on page 9 of the Prospectus and any applicable prospectus supplement.
We are a “smaller reporting company” as defined by Rule 12b-2 of the Exchange Act and are subject to reduced public company reporting requirements.
Neither the SEC nor any state securities commission has approved or disapproved of these securities or determined if this prospectus supplement is truthful or complete. Any representation to the contrary is a criminal offense. The securities are not being offered in any jurisdiction where the offer is not permitted.
_________________________________________________________________
The date of this prospectus supplement is August 8, 2024.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
|
|
☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2024
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: 001-38541
Dianthus Therapeutics, Inc.
(Exact Name of Registrant as Specified in its Charter)
|
|
Delaware |
81-0724163 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
7 Times Square, 43rd Floor New York, New York |
10036 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (929) 999-4055
Securities registered pursuant to Section 12(b) of the Act:
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|
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
Common Stock, $0.001 par value |
|
DNTH |
|
The Nasdaq Capital Market |
Indicate by check mark whether the registrant (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. Yes ☒ No ☐
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). Yes ☒ No ☐
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.
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Large accelerated filer |
|
☐ |
|
Accelerated filer |
|
☐ |
Non-accelerated filer |
|
☒ |
|
Smaller reporting company |
|
☒ |
|
|
|
|
Emerging growth company |
|
☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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, 2024, the registrant had 29,354,320 shares of common stock, $0.001 par value per share, outstanding.
Table of Contents
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 DNTH103 or any other product candidate, our anticipated preclinical and clinical drug development activities, in particular with respect to DNTH103, 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 DNTH103, the receipt or timing of potential regulatory designations, approvals and commercialization of any product candidates and other statements, including those included under the sections titled “Risk Factors” and “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 risks, uncertainties and factors:
•expectations regarding the strategies, prospects, plans, expectations and objectives of our management for future operations of the Company;
•risks associated with our ability to manage expenses and unanticipated spending and costs that could reduce our cash resources;
•risks related to our ability to correctly estimate our operating expenses and other events;
•changes in capital resource requirements;
•our ability to obtain, maintain and protect our intellectual property rights, in particular those related to our product candidates;
•our ability to advance the development of our product candidates or preclinical activities under the timelines we anticipate in planned and future clinical trials;
•our ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of our product candidates;
•our ability to realize the anticipated benefits of our research and development programs, strategic partnerships, licensing programs or other collaborations;
•regulatory requirements or developments, and our ability to obtain necessary approvals from the U.S. Food and Drug Administration (the “FDA”) or other regulatory authorities;
•our ability to manufacture product candidates in conformity with the FDA or other regulatory authorities’ requirements and to scale up manufacturing of our product candidates to commercial scale, if approved;
•changes to clinical trial designs and regulatory pathways;
•developments and projections relating to our expected or existing competitors or industry;
•unexpected costs, charges or expenses resulting from the Reverse Merger;
•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, instability in financial institutions, the prospect of a shutdown of the U.S. federal government, the ongoing
conflict in Ukraine, conflict in the Middle East, rising tensions between China and Taiwan, the attacks on marine vessels traversing the Red Sea and the responses thereto, pandemics or other public health crises and supply chain disruptions;
•success in retaining, recruiting or changes required in, our officers, key employees or directors;
•the liquidity and trading of our securities;
•regulatory actions with respect to our product candidates or our competitors’ products and product candidates;
•our ability to successfully develop and commercialize any technology that we may in-license or products we may acquire;
•our ability to successfully operate in non-U.S. jurisdictions in which we may choose to do business, including compliance with applicable regulatory requirements and laws;
•our reliance on third-party contract development and manufacturer organizations to manufacture and supply product candidates;
•our ability to establish satisfactory pricing and obtain adequate reimbursement from government and third-party payors of products and product candidates that receive regulatory approvals, if any;
•our ability to successfully commercialize product candidates, if approved, and the rate and degree of market acceptance of such product candidates;
•risks related to our ability to obtain additional financing and raise capital as necessary to fund operations or pursue business opportunities;
•the direct and indirect effects of widespread health emergencies on our workforce, operations, financial results and cash flows;
•severe weather and seasonal factors;
•our inability to continue to grow and manage our growth effectively;
•our inability to comply with, and the effect on our business of, evolving legal standards and regulations, including those concerning data protection, consumer privacy and sustainability and evolving labor standards; and
•our ability to remediate material weaknesses or other deficiencies in our internal control over financial reporting or to maintain effective disclosure controls and procedures and internal control over financial reporting.
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” and “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, 2023 and in our other filings with the Securities and Exchange Commission (“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.
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.) after the completion of the Reverse Merger (as defined elsewhere in this Quarterly Report on Form 10-Q), 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.
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)
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
314,169 |
|
|
$ |
132,325 |
|
Short-term investments |
|
|
46,538 |
|
|
|
41,393 |
|
Receivable from related party |
|
|
840 |
|
|
|
294 |
|
Unbilled receivable from related party |
|
|
835 |
|
|
|
184 |
|
Prepaid expenses and other current assets |
|
|
3,305 |
|
|
|
3,255 |
|
Total current assets |
|
|
365,687 |
|
|
|
177,451 |
|
Property and equipment, net |
|
|
189 |
|
|
|
185 |
|
Right-of-use operating lease assets |
|
|
442 |
|
|
|
615 |
|
Other assets and restricted cash |
|
|
2,641 |
|
|
|
1,154 |
|
Total assets |
|
$ |
368,959 |
|
|
$ |
179,405 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,695 |
|
|
$ |
2,610 |
|
Accrued expenses |
|
|
5,857 |
|
|
|
6,504 |
|
Current portion of deferred revenue - related party |
|
|
100 |
|
|
|
100 |
|
Current portion of operating lease liabilities |
|
|
377 |
|
|
|
417 |
|
Total current liabilities |
|
|
10,029 |
|
|
|
9,631 |
|
Deferred revenue - related party |
|
|
682 |
|
|
|
736 |
|
Long-term operating lease liabilities |
|
|
30 |
|
|
|
168 |
|
Total liabilities |
|
|
10,741 |
|
|
|
10,535 |
|
Commitments and contingencies (Note 15) |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock; $0.001 par value per share; authorized shares – 10,000,000 at June 30, 2024 and December 31, 2023; issued and outstanding – none at June 30, 2024 and December 31, 2023 |
|
|
— |
|
|
|
— |
|
Common stock; $0.001 par value per share; authorized shares – 150,000,000 at June 30, 2024 and December 31, 2023; issued and outstanding shares – 29,352,140 and 14,817,696 at June 30, 2024 and December 31, 2023, respectively |
|
|
29 |
|
|
|
15 |
|
Additional paid-in capital |
|
|
479,004 |
|
|
|
258,231 |
|
Accumulated deficit |
|
|
(120,778 |
) |
|
|
(89,423 |
) |
Accumulated other comprehensive (loss)/income |
|
|
(37 |
) |
|
|
47 |
|
Total stockholders’ equity |
|
|
358,218 |
|
|
|
168,870 |
|
Total liabilities and stockholders’ equity |
|
$ |
368,959 |
|
|
$ |
179,405 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
DIANTHUS THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
License revenue - related party |
|
$ |
1,863 |
|
|
$ |
969 |
|
|
$ |
2,737 |
|
|
$ |
1,445 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
18,070 |
|
|
|
10,253 |
|
|
|
31,148 |
|
|
|
16,100 |
|
General and administrative |
|
|
5,997 |
|
|
|
2,492 |
|
|
|
11,637 |
|
|
|
4,804 |
|
Total operating expenses |
|
|
24,067 |
|
|
|
12,745 |
|
|
|
42,785 |
|
|
|
20,904 |
|
Loss from operations |
|
|
(22,204 |
) |
|
|
(11,776 |
) |
|
|
(40,048 |
) |
|
|
(19,459 |
) |
Other income/(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
4,708 |
|
|
|
687 |
|
|
|
8,930 |
|
|
|
1,293 |
|
Loss on currency exchange, net |
|
|
(31 |
) |
|
|
(28 |
) |
|
|
(43 |
) |
|
|
(37 |
) |
Other expense |
|
|
(80 |
) |
|
|
(23 |
) |
|
|
(194 |
) |
|
|
(26 |
) |
Total other income |
|
|
4,597 |
|
|
|
636 |
|
|
|
8,693 |
|
|
|
1,230 |
|
Net loss |
|
$ |
(17,607 |
) |
|
$ |
(11,140 |
) |
|
$ |
(31,355 |
) |
|
$ |
(18,229 |
) |
Net loss per share attributable to common stockholders, basic and diluted |
|
$ |
(0.51 |
) |
|
$ |
(12.73 |
) |
|
$ |
(0.99 |
) |
|
$ |
(20.84 |
) |
Weighted-average number of shares of common stock outstanding including shares issuable under equity-classified pre-funded warrants, used in computing net loss per share of common stock, basic and diluted |
|
|
34,227,038 |
|
|
|
874,900 |
|
|
|
31,794,881 |
|
|
|
874,805 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(17,607 |
) |
|
$ |
(11,140 |
) |
|
$ |
(31,355 |
) |
|
$ |
(18,229 |
) |
Other comprehensive (loss)/income: |
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized (losses)/gains related to available-for-sale debt securities |
|
|
(10 |
) |
|
|
38 |
|
|
|
(84 |
) |
|
|
142 |
|
Total other comprehensive (loss)/income |
|
|
(10 |
) |
|
|
38 |
|
|
|
(84 |
) |
|
|
142 |
|
Total comprehensive loss |
|
$ |
(17,617 |
) |
|
$ |
(11,102 |
) |
|
$ |
(31,439 |
) |
|
$ |
(18,087 |
) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
DIANTHUS THERAPEUTICS, INC.
Condensed Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity/(Deficit)
(in thousands, except share data)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
Total |
|
|
|
Convertible Preferred Stock |
|
|
|
Common Stock |
|
|
Additional |
|
|
Accumulated |
|
|
Comprehensive |
|
|
Stockholders’ |
|
|
|
Shares |
|
|
Amount |
|
|
|
Shares |
|
|
Amount |
|
|
Paid-in Capital |
|
|
Deficit |
|
|
Income/(Loss) |
|
|
Equity/(Deficit) |
|
Balance, December 31, 2023 |
|
|
— |
|
|
$ |
— |
|
|
|
|
14,817,696 |
|
|
$ |
15 |
|
|
$ |
258,231 |
|
|
$ |
(89,423 |
) |
|
$ |
47 |
|
|
$ |
168,870 |
|
Issuance of common stock and pre-funded warrants in connection with the private placement, net of issuance costs of $14,665 |
|
|
— |
|
|
|
— |
|
|
|
|
14,500,500 |
|
|
|
14 |
|
|
|
215,319 |
|
|
|
— |
|
|
|
— |
|
|
|
215,333 |
|
Exercise of stock options |
|
|
— |
|
|
|
— |
|
|
|
|
30,430 |
|
|
|
— |
|
|
|
271 |
|
|
|
— |
|
|
|
— |
|
|
|
271 |
|
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
2,035 |
|
|
|
— |
|
|
|
— |
|
|
|
2,035 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(13,748 |
) |
|
|
— |
|
|
|
(13,748 |
) |
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(74 |
) |
|
|
(74 |
) |
Balance, March 31, 2024 |
|
|
— |
|
|
$ |
— |
|
|
|
|
29,348,626 |
|
|
$ |
29 |
|
|
$ |
475,856 |
|
|
$ |
(103,171 |
) |
|
$ |
(27 |
) |
|
$ |
372,687 |
|
Exercise of stock options |
|
|
— |
|
|
|
— |
|
|
|
|
3,514 |
|
|
|
— |
|
|
|
47 |
|
|
|
— |
|
|
|
— |
|
|
|
47 |
|
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
3,101 |
|
|
|
— |
|
|
|
— |
|
|
|
3,101 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(17,607 |
) |
|
|
— |
|
|
|
(17,607 |
) |
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(10 |
) |
|
|
(10 |
) |
Balance, June 30, 2024 |
|
|
— |
|
|
$ |
— |
|
|
|
|
29,352,140 |
|
|
$ |
29 |
|
|
$ |
479,004 |
|
|
$ |
(120,778 |
) |
|
$ |
(37 |
) |
|
$ |
358,218 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2022 |
|
|
33,336,282 |
|
|
$ |
118,024 |
|
|
|
|
875,279 |
|
|
$ |
— |
|
|
$ |
1,661 |
|
|
$ |
(45,868 |
) |
|
$ |
(161 |
) |
|
$ |
(44,368 |
) |
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
533 |
|
|
|
— |
|
|
|
— |
|
|
|
533 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(7,089 |
) |
|
|
— |
|
|
|
(7,089 |
) |
Other comprehensive income |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
104 |
|
|
|
104 |
|
Balance, March 31, 2023 |
|
|
33,336,282 |
|
|
$ |
118,024 |
|
|
|
|
875,279 |
|
|
$ |
— |
|
|
$ |
2,194 |
|
|
$ |
(52,957 |
) |
|
$ |
(57 |
) |
|
$ |
(50,820 |
) |
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
462 |
|
|
|
— |
|
|
|
— |
|
|
|
462 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(11,140 |
) |
|
|
— |
|
|
|
(11,140 |
) |
Other comprehensive income |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
38 |
|
|
|
38 |
|
Balance, June 30, 2023 |
|
|
33,336,282 |
|
|
$ |
118,024 |
|
|
|
|
875,279 |
|
|
$ |
— |
|
|
$ |
2,656 |
|
|
$ |
(64,097 |
) |
|
$ |
(19 |
) |
|
$ |
(61,460 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
DIANTHUS THERAPEUTICS, INC.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
Net loss |
|
$ |
(31,355 |
) |
|
$ |
(18,229 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
Depreciation expense |
|
|
45 |
|
|
|
28 |
|
Stock-based compensation expense |
|
|
5,136 |
|
|
|
995 |
|
Accretion of discount on short-term investments |
|
|
(940 |
) |
|
|
(566 |
) |
Amortization of right-of-use operating lease assets |
|
|
173 |
|
|
|
137 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Receivable from related party |
|
|
(546 |
) |
|
|
4,338 |
|
Unbilled receivable from related party |
|
|
(651 |
) |
|
|
520 |
|
Prepaid expenses and other current assets |
|
|
(50 |
) |
|
|
656 |
|
Deferred transaction costs |
|
|
— |
|
|
|
(1,163 |
) |
Other assets |
|
|
(1,487 |
) |
|
|
12 |
|
Accounts payable, accrued expenses and operating lease liabilities |
|
|
260 |
|
|
|
(1,715 |
) |
Deferred revenue - related party |
|
|
(54 |
) |
|
|
(28 |
) |
Net cash used in operating activities |
|
|
(29,469 |
) |
|
|
(15,015 |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
Capital expenditures |
|
|
(49 |
) |
|
|
(35 |
) |
Purchases of short-term investments |
|
|
(27,289 |
) |
|
|
(3,855 |
) |
Proceeds from maturities of short-term investments |
|
|
23,000 |
|
|
|
43,885 |
|
Net cash (used in)/provided by investing activities |
|
|
(4,338 |
) |
|
|
39,995 |
|
Cash flows from financing activities: |
|
|
|
|
|
|
Proceeds from exercise of stock options |
|
|
318 |
|
|
|
— |
|
Proceeds from the private placement |
|
|
229,998 |
|
|
|
— |
|
Payment of issuance costs in connection with the private placement |
|
|
(14,665 |
) |
|
|
— |
|
Proceeds from issuance of promissory notes payable to related party |
|
|
— |
|
|
|
377 |
|
Repayment of promissory notes payable to related party |
|
|
— |
|
|
|
(377 |
) |
Net cash provided by financing activities |
|
|
215,651 |
|
|
|
— |
|
Increase in cash, cash equivalents and restricted cash |
|
|
181,844 |
|
|
|
24,980 |
|
Cash, cash equivalents and restricted cash, beginning of period |
|
|
132,391 |
|
|
|
15,425 |
|
Cash, cash equivalents and restricted cash, end of period |
|
$ |
314,235 |
|
|
$ |
40,405 |
|
Supplemental Disclosure |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
314,169 |
|
|
$ |
40,280 |
|
Restricted cash |
|
|
66 |
|
|
|
125 |
|
Total cash, cash equivalents and restricted cash |
|
$ |
314,235 |
|
|
$ |
40,405 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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. (formerly Magenta Therapeutics, Inc.) (the “Company” or “Dianthus”) is a clinical-stage biotechnology company focused on developing next-generation complement therapeutics for patients 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.
Immediately prior to the effective time of the Reverse Merger, the Company effected a 1-for-16 reverse stock split of its common stock (the “Reverse Stock Split”). Unless noted otherwise, all references herein to share and per share amounts reflect the Reverse Stock Split.
At the effective time of the Reverse Merger, the Company issued an aggregate of 11,021,248 shares of Company common stock to the Former Dianthus stockholders, based on the exchange ratio of approximately 0.2181 shares of Company common stock for each share of Former Dianthus common stock, including those shares of Former Dianthus common stock issued upon the conversion of Former Dianthus preferred stock and those shares of the Former Dianthus common stock issued in the pre-closing financing (as defined below), resulting in 14,817,696 shares of Company common stock being issued and outstanding following the effective time of the Reverse Merger.
At the effective time of the Reverse Merger, the 2019 Stock Plan (as discussed in Note 12) 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.
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 own a substantial majority of the voting rights in the combined company; (ii) Former Dianthus’ largest stockholders 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 are 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. Additional information regarding the Reverse Merger is included in Note 3. Historical common stock figures of Former Dianthus have been retroactively restated based on the exchange ratio of approximately 0.2181.
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. As of June 30, 2024, no payments have been received under the CVR Agreement.
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) 2,873,988 shares of Former Dianthus common stock and (ii) 210,320 pre-funded warrants, exercisable for 210,320 shares of Former Dianthus common stock, at a purchase price of approximately $23.34 per share or $23.34 per warrant, for an aggregate purchase price of approximately $72.0 million (the “pre-closing financing”).
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 14,500,500 shares of common stock at a price per share of $12.00, and pre-funded warrants to purchase 4,666,332 shares of common stock at a purchase price of $11.999 per pre-funded warrant, which represents the per share purchase price of the common stock less the $0.001 per share exercise price for each pre-funded warrant, for an aggregate purchase price of approximately $230 million. The pre-funded warrants are exercisable at any time after the date of issuance. A holder of pre-funded warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than 9.99% of the number of shares of common stock outstanding immediately after giving effect to such exercise. A holder of pre-funded warrants may increase or decrease this percentage to a percentage not in excess of 19.99% by providing at least 61 days’ prior notice to the Company.
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”):
•Since its inception, the Company has funded its operations primarily with outside capital and has incurred significant recurring losses, including net losses of $31.4 million and $18.2 million for the six months ended June 30, 2024 and 2023, respectively. In addition, the Company had an accumulated deficit of $120.8 million as of June 30, 2024;
•The Company expects to continue to incur significant recurring losses and rely on outside capital to fund its operations for the foreseeable future; and
•As of the issuance date, the Company expects that its existing cash, cash equivalents and short-term investments on hand will be sufficient to fund its obligations as they become due for at least twelve months beyond the issuance date. The Company expects that its research and development and general and administrative costs will continue to increase significantly, including in connection with conducting clinical trials and manufacturing for its existing product candidate and any future product candidates to support commercialization and providing general and administrative support for its operations, including the costs associated with operating as a public company.
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.
The accompanying unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties. Accordingly, the unaudited condensed consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements as of June 30, 2024 and for the six months ended June 30, 2024 and 2023 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, 2024 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, 2023 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, 2023, which are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (“SEC”) on March 21, 2024. 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 expense and revenue recognition.
Cash and Cash Equivalents
All short-term, highly liquid investments with original maturities of 90 days or less are considered to be cash and cash equivalents. The carrying amounts reported in the unaudited condensed consolidated balance sheets for cash and cash equivalents are valued at cost, which approximates fair value.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents and short-term investments. The Company regularly maintains deposits in accredited financial institutions in excess of federally insured limits. The Company invests its excess cash primarily in money market funds, U.S. treasury securities and U.S. government agency securities in accordance with the Company’s investment policy. The Company’s investment policy defines allowable investments and establishes guidelines relating to credit quality, diversification, and maturities of its investments to preserve principal and maintain liquidity. The Company has not experienced any realized losses related to its cash, cash equivalents and short-term investments and management believes the Company is not exposed to significant risks of losses.
As of June 30, 2024 and December 31, 2023, the Company held cash deposits at Silicon Valley Bank (“SVB”) in excess of government insured limits. On March 10, 2023, SVB was closed by the California Department of Financial Protection and Innovation, and the Federal Deposit Insurance Corporation was appointed as receiver. No losses were incurred by the Company on deposits that were held at SVB. Management believes that the Company is not currently exposed to significant credit risk as the vast majority of the Company’s deposits were either owned directly by the Company and held in custody at a third-party financial institution or, subsequent to March 10, 2023, have been transferred to a third-party financial institution. The Company does not currently have any other significant relationships with SVB.
Short-term Investments
Short-term investments consist of investments in U.S. treasury and U.S. government agency securities. Management of the Company determines the appropriate classification of the securities at the time they are acquired and evaluates the appropriateness of such classifications at each balance sheet date. The Company classifies its short-term investments as available-for-sale pursuant to ASC 320, Investments – Debt and Equity Securities, and reports them at fair value in short-term investments with unrealized gains and losses reported as a component of accumulated other comprehensive income/(loss) on the unaudited condensed consolidated balance sheets. Realized gains and losses and declines in value judged to be other than temporary are included as a component of interest income based on the specific identification method.
When the fair value is below the amortized cost of a marketable security, an estimate of expected credit losses is made in accordance with ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The credit-related impairment amount is recognized in the unaudited condensed consolidated statements of operations and comprehensive loss. Credit losses are recognized through the use of an allowance for credit losses account in the unaudited condensed consolidated balance sheet and subsequent improvements in expected credit losses are recognized as a reversal of an amount in the allowance account. If the Company has the intent to sell the security or it is more likely than not that the Company will be required to sell the security prior to recovery of its amortized cost basis, then the allowance for the credit loss is written-off and the excess of the amortized cost basis of the asset over its fair value is recorded in the unaudited condensed consolidated statements of operations and comprehensive loss. There were no credit losses recorded during the six months ended June 30, 2024 or 2023.
Additional information regarding short-term investments is included in Note 4.
Receivable from Related Party and Unbilled Receivable from Related Party
The receivable from related party and unbilled receivable from related party results from option and license agreements with Zenas BioPharma, Inc. (formerly Zenas BioPharma Limited) (“Zenas”), a related party. See Notes 13 and 16 for more information. The receivable represents amounts earned and billed to Zenas but not yet collected while unbilled receivable represents amounts earned but not yet billed to Zenas. The receivable and unbilled receivable are reported at net realizable value. The Company regularly evaluates the creditworthiness of Zenas and their financial condition and does not require collateral from Zenas. As of June 30, 2024 and December 31, 2023, no allowance for doubtful accounts was recorded as all accounts were considered collectible.
Property and Equipment
Property and equipment are recorded at cost. Depreciation is provided using the straight-line method over estimated useful lives of three years for computer equipment and five years for furniture and fixtures. Expenditures for major renewals and betterments that extend the useful lives are capitalized. Expenditures for normal maintenance and repairs are expensed as incurred. The cost of assets sold or abandoned, and the related accumulated depreciation are eliminated from the accounts and any gains or losses are recognized in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss of the respective period.
Leases
Operating leases are accounted for in accordance with ASU 2016-02, Leases, as amended (“ASC 842”). Right-of-use lease assets represent the right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments arising from the lease. The measurement of lease liabilities is based on the present value of future lease payments over the lease term. As the Company’s leases do not provide an implicit rate, management used the Company’s incremental borrowing rate based on the information available at the lease commencement date in determining the present value of future lease payments. The right-of-use asset is based on the measurement of the lease liability and includes any lease payments made prior to or on lease commencement and excludes lease incentives and initial direct costs incurred, as applicable. Rent expense for operating leases is recognized on a straight-line basis over the lease term. The Company does not have any leases classified as finance leases. Management have elected the practical expedient to exclude short-term leases from right-of-use assets and lease liabilities.
The Company’s leases do not have significant rent escalation, holidays, concessions, material residual value guarantees, material restrictive covenants or contingent rent provisions. The Company’s leases include both lease (e.g., fixed payments including rent, taxes, and insurance costs) and non-lease components (e.g., common-area or other maintenance costs), which are accounted for as a single lease component as management have elected the practical expedient to group lease and non-lease components for all leases.
Additional information and disclosures required under ASC 842 are included in Note 9.
Restricted Cash
In accordance with ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash, restricted cash is included as a component of cash, cash equivalents and restricted cash in the accompanying unaudited condensed consolidated statements of cash flows. Restricted cash serves as collateral for a letter of credit securing office space. Restricted cash is recorded within other assets and restricted cash line item in the accompanying unaudited condensed consolidated balance sheets.
Fair Value Measurements
The Company calculates the fair value of assets and liabilities that qualify as financial instruments and includes additional information in the notes to the unaudited condensed consolidated financial statements when the fair value is different than the carrying value of these financial instruments.
The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. ASC Topic 820, Fair Value Measurements and Disclosures (“ASC 820”), defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. ASC 820 establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available.
Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect management’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality.
The three levels of the fair value hierarchy are described below:
•Level 1 - Quoted prices in active markets for identical assets or liabilities.
•Level 2 - Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data.
•Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets and liabilities. This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques that use significant unobservable inputs.
To the extent that a valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by management in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
Management has segregated all financial assets and liabilities that are measured at fair value on a recurring basis into the most appropriate level within the fair value hierarchy based on the inputs used to determine the fair value at the measurement date in the table below. The Company’s valuation techniques for its Level 2 financial assets included using quoted prices for similar assets in active markets and quoted prices for similar assets in markets that are not active.
The estimated fair value of receivable from related party, unbilled receivable from related party, accounts payable and accrued expenses approximate their carrying amounts due to the relatively short maturity of these instruments.
Additional information regarding fair value measurements is included in Note 7.
Classification of Convertible Preferred Stock
Convertible preferred stock was recorded at its original issuance price, less direct and incremental offering costs, as stipulated by its terms. The Company had applied the guidance in ASC 480-10-S99, Distinguishing Liabilities from Equity-Overall-SEC Materials, and had therefore classified the convertible preferred stock outside of stockholders’ equity/(deficit). In September 2023, all outstanding shares of convertible preferred stock were converted into shares of common stock immediately prior to the effective time of the Reverse Merger. Additional information and disclosures are included in Note 11.
Segment Information
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 (“CODM”) in deciding how to allocate resources and in assessing performance. The Company’s CODM is its Chief Executive Officer (“CEO”). The Company operates as a single operating segment and has one reportable segment.
License Revenue – Related Party
To date, the Company’s only revenue has been attributable to an upfront payment and cost reimbursements under the Company’s license agreement with Zenas. The Company has not generated any revenue from product sales and does not expect to generate any revenue from product sales for the foreseeable future.
The Company recognizes revenue pursuant to ASC 606, Revenue from Contracts with Customers (“ASC 606”). ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when the performance obligation is satisfied.
The Company evaluates the performance obligations promised in a contract that are based on goods and services that will be transferred to the customer and determines whether those obligations are both (i) capable of being distinct and (ii) distinct in the context of the contract. To the extent a contract includes multiple promised goods and services, the Company applies judgment to determine whether promised goods and services are both capable of being distinct and are distinct in the context of the contract. If these criteria are not met, the promised goods and services are accounted for as a combined performance obligation. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations.
The Company estimates the transaction price based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration may include fixed consideration or variable consideration. At the inception of each arrangement that includes variable consideration, the Company evaluates the amount of potential transaction price and the likelihood that the transaction price will be received. Variable consideration is included in the transaction price if, in management’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Any estimates, including the effect of the constraint on variable consideration, are evaluated at each reporting period for any changes. The Company then allocates the transaction price to each performance obligation and recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied.
Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in the Company’s unaudited condensed consolidated balance sheets. If the related performance obligation is expected to be satisfied within the next twelve months this will be classified in current liabilities.
Additional information and disclosures required under ASC 606 are included in Note 13.
Research and Development Costs
Research and development expenses are recorded as expense, as incurred. Research and development expenses consists of (i) costs to engage contractors who specialize in the development activities of the Company; (ii) external research and development costs incurred under arrangements with third parties, such as contract research organizations and consultants; and (iii) costs associated with preclinical activities and regulatory operations.
The Company enters into consulting, research, and other agreements with commercial firms, researchers, and others for the provision of goods and services. Under such agreements, the Company may pay for services on a monthly, quarterly, project or other basis. Such arrangements are generally cancelable upon reasonable notice and payment of costs incurred. Costs are considered incurred based on an evaluation of the progress to completion of specific tasks under each contract using information and data provided by the service providers and vendors or our estimate of the level of service that has been performed at each reporting date, whereas payments are dictated by the terms of each agreement. As such, depending on the timing of payment relative to the receipt of goods or services, management may record either prepaid expenses or accrued services. These costs consist of direct and indirect costs associated with specific projects, as well as fees paid to various entities that perform certain research on behalf of the Company.
Patent Costs
Patent costs are expensed as incurred and recorded within general and administrative expenses.
Income Taxes
Income taxes are recorded in accordance with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities and for loss and credit carryforwards using enacted tax rates anticipated to be in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if, based upon the weight of available evidence, it is more likely than not that some or all the deferred tax assets will not be realized.
The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. As of June 30, 2024 and December 31, 2023, the Company did not have any material uncertain tax positions. The Company recognizes interest and penalties related to uncertain tax positions, if any exist, in income tax expense.
Stock-Based Compensation
The Company accounts for stock-based compensation awards in accordance with ASC Topic 718, Compensation – Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments, including grants of stock options and restricted stock, to be recognized in the unaudited condensed consolidated statements of operations and comprehensive loss based on their fair values. All of the stock-based awards are subject only to service-based vesting conditions. Management estimates the fair value of the stock option awards using the Black-Scholes option pricing model, which requires the input of assumptions, including (a) the fair value of the Company’s common stock, (b) the expected stock price volatility, (c) the calculation of expected term of the award, (d) the risk-free interest rate and (e) expected dividends. Management estimates the fair value of the restricted stock awards, if any, using the fair value of the Company’s common stock. Forfeitures are recognized as they are incurred.
Prior to the Reverse Merger, management utilized valuation methodologies in accordance with the framework of the American Institute of Certified Public Accountants Technical Practice Aid, Valuation of Privately Held Company Equity Securities Issued as Compensation, to estimate the fair value of Former Dianthus common stock. Each valuation methodology included estimates and assumptions that required management’s judgment. These estimates and assumptions included objective and subjective factors, including external market conditions, the prices at which Former Dianthus sold shares of convertible preferred stock, the superior rights and preferences of the convertible preferred stock senior to Former Dianthus common stock at the time, and a probability analysis of various liquidity events, such as a public offering or sale of Former Dianthus, under differing scenarios. Changes to the key assumptions used in the valuations could have resulted in materially different fair values of Former Dianthus common stock at each valuation date. Following the Reverse Merger, the fair value of the Company’s common stock is based on the closing stock price on the date of grant as reported on the Nasdaq Capital Market.
Prior to the Reverse Merger, due to a lack of company-specific historical and implied volatility data, management based its estimate of expected volatility on the historical volatility of a representative group of companies with similar characteristics to the Company, including stage of product development and life science industry focus. Management believes the group selected had sufficiently similar economic and industry characteristics and includes companies that are most representative of the Company. Following the Reverse Merger, expected volatility at the date of grant is estimated using a “look-back” period, which coincides with the expected term, of the Company's stock price as reported on the Nasdaq Capital Market.
Management uses the simplified method, as prescribed by the SEC Staff Accounting Bulletin No. 107, Share-Based Payment, to calculate the expected term. The risk-free interest rate is based on observed interest rates appropriate for the term of the awards. The dividend yield assumption is based on history and expectation of paying no dividends.
Compensation expense related to stock-based awards is calculated on a straight-line basis by recognizing the grant date fair value, over the associated service period of the award, which is generally the vesting term.
Additional information regarding stock-based compensation is included in Note 12.
Comprehensive Loss
The only component of comprehensive loss other than net loss is change in unrealized gains/losses related to available-for-sale debt securities.
Net Loss per Share
Basic and diluted net loss per share attributable to common stockholders is computed by dividing net loss by the weighted-average number of common shares outstanding during the period. The weighted average number of common shares outstanding includes the weighted average effect of outstanding pre-funded warrants for the purchase of shares of common stock for which the remaining unfunded exercise price is $0.001 or less per share.
Basic and diluted net loss per share attributable to common stockholders are calculated in conformity with the two-class method required for participating securities. Convertible preferred stock is a participating security in distributions of the Company. During the three and six months ended June 30, 2023, the net loss attributable to common stockholders was not allocated to the convertible preferred shares as the holders of convertible preferred shares did not have a contractual obligation to share in losses. Under the two-class method, basic net loss per share of common stock is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each period. During the three and six months ended June 30, 2023, the weighted-average number of shares of common stock outstanding used in the basic net loss per share calculation did not include unvested restricted common stock as these shares were considered contingently issuable shares until they vested.
Diluted net loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as convertible preferred stock, stock options and unvested restricted common stock, if any, which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock outstanding is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive. For all periods presented, basic and diluted net loss per share were the same, as any additional share equivalents would be anti-dilutive.
Additional information is included in Note 14.
Recently Issued Accounting Pronouncements
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07 expands annual and interim disclosure requirements for reportable segments, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods beginning after December 14, 2024, with early adoption permitted. The Company is currently evaluating the guidance and has not determined the impact this standard may have on the unaudited condensed consolidated financial statements.
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 will provide 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. Investors currently rely on the rate reconciliation table and other disclosures, including total income taxes paid, to evaluate income tax risks and opportunities. ASU No. 2023-09 is effective for fiscal years beginning after December 15, 2024 and early adoption is permitted. The Company is currently evaluating the impact ASU No. 2023-09 will have on the unaudited condensed consolidated financial statements and related disclosures.
3. Reverse Merger
As described in Note 1, Merger Sub merged with and into Former Dianthus, with Former Dianthus surviving as a wholly owned subsidiary of the Company on September 11, 2023. The Reverse Merger was accounted for as a reverse asset acquisition accounted for as a reverse recapitalization in accordance with U.S. GAAP with Former Dianthus as the accounting acquirer of Magenta. At the effective time of the Reverse Merger, substantially all of the assets of Magenta consisted of cash and cash equivalents, marketable securities, as well as other nominal non-operating assets. Under such reverse recapitalization accounting, the assets and liabilities of Magenta were recorded at their fair value in Magenta’s financial statements at the effective time of the Reverse Merger, which approximated book value due to the short-term nature. No goodwill or intangible assets were recognized.
As part of the recapitalization, the Company obtained the assets and liabilities listed below:
|
|
|
|
|
Cash and cash equivalents |
|
$ |
69,738 |
|
Other current assets |
|
|
2,473 |
|
Accrued liabilities |
|
|
(616 |
) |
Net assets acquired |
|
$ |
71,595 |
|
With respect to the CVRs issued in connection with 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, 2024, no receivables are recorded on the unaudited condensed consolidated balance sheet relating to such contingent payments.
4. Short-Term Investments
The following table provides a summary of short-term investments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
|
Amortized Cost |
|
|
Gross Unrealized Gain |
|
|
Gross Unrealized Loss |
|
|
Fair Value |
|
Available-for-sale, short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasury securities |
|
$ |
45,574 |
|
|
$ |
— |
|
|
$ |
(35 |
) |
|
$ |
45,539 |
|
U.S. government agency securities |
|
|
1,001 |
|
|
|
— |
|
|
|
(2 |
) |
|
|
999 |
|
Total available-for-sale, short-term investments |
|
$ |
46,575 |
|
|
$ |
— |
|
|
$ |
(37 |
) |
|
$ |
46,538 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2023 |
|
|
|
Amortized Cost |
|
|
Gross Unrealized Gain |
|
|
Gross Unrealized Loss |
|
|
Fair Value |
|
Available-for-sale, short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasury securities |
|
$ |
36,370 |
|
|
$ |
48 |
|
|
$ |
— |
|
|
$ |
36,418 |
|
U.S. government agency securities |
|
|
4,976 |
|
|
|
— |
|
|
|
(1 |
) |
|
|
4,975 |
|
Total available-for-sale, short-term investments |
|
$ |
41,346 |
|
|
$ |
48 |
|
|
$ |
(1 |
) |
|
$ |
41,393 |
|
5. Prepaid Expenses and Other Current Assets
The following table provides a summary of prepaid expenses and other current assets:
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
Prepaid materials, supplies and research and development services |
|
$ |
2,305 |
|
|
$ |
2,155 |
|
Prepaid subscriptions, software and other administrative services |
|
|
797 |
|
|
|
504 |
|
Prepaid insurance |
|
|
203 |
|
|
|
596 |
|
Prepaid expenses and other current assets |
|
$ |
3,305 |
|
|
$ |
3,255 |
|
6. Property and Equipment
The following table provides a summary of property and equipment:
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
Computer equipment |
|
$ |
281 |
|
|
$ |
234 |
|
Furniture and fixtures |
|
|
50 |
|
|
|
48 |
|
Subtotal |
|
|
331 |
|
|
|
282 |
|
Less: accumulated depreciation |
|
|
(142 |
) |
|
|
(97 |
) |
Property and equipment, net |
|
$ |
189 |
|
|
$ |
185 |
|
Depreciation expense was $23 thousand and $45 thousand during the three and six months ended June 30, 2024, respectively, and $15 thousand and $28 thousand during the three and six months ended June 30, 2023, respectively.
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, 2024 |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
Recurring Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
313,103 |
|
|
$ |
313,103 |
|
|
$ |
— |
|
|
$ |
— |
|
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasury securities |
|
|
45,539 |
|
|
|
45,539 |
|
|
|
— |
|
|
|
— |
|
U.S. government agency securities |
|
|
999 |
|
|
|
— |
|
|
|
999 |
|
|
|
— |
|
Total assets measured at fair value |
|
$ |
359,641 |
|
|
$ |
358,642 |
|
|
$ |
999 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value at |
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
|
|
|
|
|
Description |
|
2023 |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
Recurring Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
131,193 |
|
|
$ |
131,193 |
|
|
$ |
— |
|
|
$ |
— |
|
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasury securities |
|
|
36,418 |
|
|
|
36,418 |
|
|
|
— |
|
|
|
— |
|
U.S. government agency securities |
|
|
4,975 |
|
|
|
— |
|
|
|
4,975 |
|
|
|
— |
|
Total assets measured at fair value |
|
$ |
172,586 |
|
|
$ |
167,611 |
|
|
$ |
4,975 |
|
|
$ |
— |
|
There were no transfers between levels for the six months ended June 30, 2024 or for the year ended December 31, 2023.
8. Accrued Expenses
The following table provides a summary of accrued expenses:
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
Accrued external research and development |
|
$ |
2,797 |
|
|
|
456 |
|
Accrued compensation |
|
|
2,602 |
|
|
|
5,361 |
|
Accrued professional fees |
|
|
211 |
|
|
|
422 |
|
Other accrued expenses |
|
|
247 |
|
|
|
265 |
|
Accrued expenses |
|
$ |
5,857 |
|
|
$ |
6,504 |
|
9. Leases
The Company leases space under operating leases for administrative offices in New York, New York, and Waltham, Massachusetts and wet laboratory space in Watertown, Massachusetts.
The following table provides a summary of the components of lease costs and rent:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Operating lease cost |
|
$ |
103 |
|
|
$ |
88 |
|
|
$ |
206 |
|
|
$ |
175 |
|
Variable lease cost |
|
|
7 |
|
|
|
6 |
|
|
|
15 |
|
|
|
13 |
|
Total operating lease costs |
|
$ |
110 |
|
|
$ |
94 |
|
|
$ |
221 |
|
|
$ |
188 |
|
The Company recorded operating lease costs of $0.1 million and $0.2 million during each of the three and six months ended June 30, 2024 and 2023, respectively, within the general and administrative expenses line item in the unaudited condensed consolidated statements of operations and comprehensive loss. The Company recorded operating lease costs of $15 thousand and $30 thousand during the three and six months ended June 30, 2024, respectively, and nil during the three and six months ended June 30, 2023 within the research and development expenses line item in the unaudited condensed consolidated statements of operations and comprehensive loss.
Maturities of operating lease liabilities as of June 30, 2024, are as follows:
|
|
|
|
|
2024 (remaining 6 months) |
|
$ |
212 |
|
2025 |
|
|
222 |
|
Total undiscounted operating lease payments |
|
|
434 |
|
Less: imputed interest |
|
|
(27 |
) |
Present value of operating lease liabilities |
|
$ |
407 |
|
|
|
|
|
Balance sheet classification: |
|
|
|
Current portion of operating lease liabilities |
|
$ |
377 |
|
Long-term operating lease liabilities |
|
|
30 |
|
Total operating lease liabilities |
|
$ |
407 |
|
The weighted-average remaining term of operating leases was 13 months and the weighted-average discount rate used to measure the present value of operating lease liabilities was 10.8% as of June 30, 2024.
10. Common Stock
At the closing of the private placement on January 24, 2024, the Company issued 14,500,500 shares of common stock and pre-funded warrants to purchase 4,666,332 shares of common stock with a $0.001 per share exercise price. The pre-funded warrants are exercisable at any time after the date of issuance and will not expire. As of June 30, 2024, there were 4,666,332 pre-funded warrants outstanding related to this private placement.
At the effective time of the Reverse Merger on September 11, 2023, the Company issued an aggregate of 11,021,248 shares of Company common stock to the Former Dianthus stockholders, based on the exchange ratio of approximately 0.2181 shares of Company common stock for each share of Former Dianthus common stock, including those shares of Former Dianthus common stock issued upon the conversion of Former Dianthus preferred stock and those shares of the Former Dianthus common stock issued in the pre-closing financing. In conjunction with the pre-closing financing, the Company also issued pre-funded warrants to purchase 210,320 shares of common stock with a $0.001 per share exercise price. The pre-funded warrants are exercisable at any time after the date of issuance and will not expire. As of June 30, 2024, there were 210,320 pre-funded warrants outstanding related to this financing.
As of June 30, 2024 and December 31, 2023, the Company was authorized to issue up to 150,000,000 shares of $0.001 par value of Company common stock. As of June 30, 2024 and December 31, 2023, the Company had issued and outstanding shares of common stock of 29,352,140 and 14,817,696, respectively.
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. No dividends have been declared or paid by the Company through June 30, 2024.
The Company had the following shares of Company common stock reserved for future issuance as of June 30, 2024 and December 31, 2023:
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2024 |
|
|
As of December 31, 2023 |
|
Issuance of common stock upon exercise of stock options |
|
|
4,420,676 |
|
|
|
1,749,475 |
|
Equity awards available for grant under stock award plans |
|
|
2,045,704 |
|
|
|
879,461 |
|
Shares available for issuance under the Employee Stock Purchase Plan |
|
|
99,578 |
|
|
|
37,078 |
|
Issuance of common stock upon exercise of warrants |
|
|
4,881,329 |
|
|
|
214,997 |
|
Total common stock reserved for future issuance |
|
|
11,447,287 |
|
|
|
2,881,011 |
|
11. Preferred Stock and Convertible Preferred Stock
Preferred Stock
As of June 30, 2024, the Company was authorized to issue up to 10,000,000 shares of preferred stock at a par value of $0.001. As of June 30, 2024, no shares of preferred stock were issued and outstanding.
Convertible Preferred Stock
On September 11, 2023, the Company completed the Reverse Merger with Former Dianthus in accordance with the Merger Agreement. Under the terms of the Merger Agreement, immediately prior to the effective time of the Reverse Merger, each share of Former Dianthus convertible preferred stock was converted into a share of Former Dianthus common stock. At closing of the Reverse Merger, the Company issued an aggregate of 7,269,183 shares of its common stock to Former Dianthus convertible preferred stockholders, based on the exchange ratio of approximately 0.2181 shares of Company common stock for each share of Former Dianthus common stock outstanding immediately prior to the Reverse Merger.
12. Stock-Based Compensation
2018 Stock Option and Incentive Plan
The Company grants stock-based awards under the Amended and Restated Dianthus Therapeutics, Inc. Stock Option and Incentive Plan (the “2018 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 2018 Incentive Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock awards, restricted stock units, unrestricted stock awards, cash-based awards, and dividend equivalent rights. In connection with the Reverse Merger, the 2018 Incentive Plan also provided for the assumption of shares remaining available for delivery under the 2019 Stock Plan (as defined below), and such shares will be available for the granting of awards under the 2018 Incentive Plan in accordance with applicable stock exchange requirements. The Company also has outstanding stock options under the Magenta Therapeutics, Inc. 2016 Stock Option and Grant Plan, as amended (the “2016 Plan”), but is no longer granting awards under the 2016 Plan.
The 2018 Incentive Plan provides that the number of shares reserved and available for issuance under the 2018 Incentive Plan will automatically increase each January 1 by 4% of the outstanding number of shares of the Company’s common stock on the immediately preceding December 31 (the “Evergreen Provision”) or such lesser number of shares as determined by the Company’s board of directors or compensation committee of the board of directors. The number of shares reserved for issuance under the 2018 Incentive Plan increased by 592,707 on January 1, 2024. Shares of common stock underlying any awards under the 2018 Incentive Plan, the 2019 Stock Plan and the 2016 Plan that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied without any issuance of stock, expire or are otherwise terminated (other than by exercise) will be available for future awards under the 2018 Incentive Plan.
On May 23, 2024, the Company's stockholders approved an amendment and restatement of the 2018 Incentive Plan (the “2018 Amended Plan”) to:
•provide for an increase in the number of shares of common stock reserved for issuance thereunder by 2,931,820 shares;
•increase the Evergreen Provision (as described above) from 4% to 5% of issued and outstanding shares of common stock on December 31 of the preceding calendar year; and
•extend the expiration date until March 14, 2034.
As of June 30, 2024, 1,953,704 shares of the Company’s common stock were available for grant under the 2018 Amended Plan.
The 2018 Amended Plan is administered by either the board of directors or the compensation committee of the board of directors. The exercise prices, vesting and other restrictions are determined at the discretion of the administrator, except that the term of stock options and stock appreciation rights may not be greater than ten years (or five years for certain incentive stock options). Awards typically vest over 12 months to four years. The exercise price for stock options granted may not be less than the fair value of common stock as of the date of grant (or 110% of the fair value of common stock for certain incentive stock options). The fair value of common stock is based on quoted market prices.
2019 Stock Plan
In July 2019, Former Dianthus’ Board of Directors adopted, and the Former Dianthus’ 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 1,273,454 shares of Company’s common stock (the “Assumed Options”). No further awards will be made under the 2019 Stock Plan; however, the Assumed Options will remain outstanding under the 2019 Stock Plan in accordance with their terms, as adjusted to reflect the Reverse Merger.
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 common stock under the ESPP is equal to 85% of the lower of the fair market value of the common stock on the offering date or the exercise date. The six-month offering periods previously began in December and June of each year. During the six months ended June 30, 2024 and 2023, there were no shares of common stock purchased under the ESPP. As of June 30, 2024, 99,578 shares remained available for issuance under the ESPP.
The ESPP provides that the number of shares reserved and available for issuance under the ESPP will automatically increase each January 1 through January 1, 2029, by the lesser of (i) 1% of the number of shares issued and outstanding on the immediately preceding December 31, (ii) 62,500 shares and (iii) such number of shares as determined by the Company’s board of directors or its appointed administrator. The number of shares reserved for issuance under the ESPP increased by 62,500 on January 1, 2024.
Stock Option Inducement Grant and Inducement Plan
In December 2023, the Company’s board of directors granted an option to purchase 96,000 shares of common stock to a new hire as an inducement grant. 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 300,000 shares of common stock for inducement awards. As of June 30, 2024, there were 92,000 shares available to be granted under the Inducement Plan.
Stock Options
The following table summarizes stock option activity for the six months ended June 30, 2024:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Stock Options Outstanding |
|
|
Weighted Average Exercise Price per Share |
|
|
Weighted Average Remaining Contractual Term |
|
|
Aggregate Intrinsic Value |
|
|
|
|
|
|
|
|
|
(in years) |
|
|
|
|
Balance at January 1, 2024 |
|
|
1,749,475 |
|
|
$ |
10.61 |
|
|
|
8.4 |
|
|
$ |
3,181 |
|
Options granted, fair value of $15.72 per share |
|
|
2,788,000 |
|
|
|
20.30 |
|
|
|
|
|
|
16,048 |
|
Options exercised |
|
|
(33,944 |
) |
|
|
9.14 |
|
|
|
|
|
|
504 |
|
Options forfeited |
|
|
(82,855 |
) |
|
|
15.52 |
|
|
|
|
|
|
926 |
|
Balance at June 30, 2024 |
|
|
4,420,676 |
|
|
$ |
16.64 |
|
|
|
9.1 |
|
|
$ |
42,783 |
|
Exercisable options at June 30, 2024 |
|
|
1,026,134 |
|
|
$ |
12.26 |
|
|
|
8.2 |
|
|
$ |
15,433 |
|
Unvested options at June 30, 2024 |
|
|
3,394,542 |
|
|
$ |
17.97 |
|
|
|
9.4 |
|
|
$ |
27,350 |
|
The aggregate intrinsic value of options is calculated as the difference between the exercise price of the options and the fair value of the common stock for those options that had exercise prices lower than the fair value of the common stock.
The weighted average grant-date fair value per share of stock options granted during the six months ended June 30, 2024 was $15.72 per share.
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, 2024 and 2023.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Risk-free interest rate |
|
|
4.5 |
% |
|
|
4.1 |
% |
|
|
4.3 |
% |
|
|
3.8 |
% |
Expected term (in years) |
|
|
6.0 |
|
|
6.1 |
|
|
|
6.0 |
|
|
6.1 |
|
Expected volatility |
|
|
92.3 |
% |
|
|
86.4 |
% |
|
|
92.7 |
% |
|
|
85.0 |
% |
Expected dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
Stock Warrants
In April 2021, Former Dianthus issued 4,677 warrants for the purchase of common stock at an exercise price of $1.65 per share. The warrants vested on July 30, 2023 and had a grant date fair value of $1.16 per warrant. As of June 30, 2024, the warrants have a weighted average remaining contractual term of 6.8 years.
Stock-based Compensation Expense
The following table provides a summary of stock-based compensation expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Research and development |
|
$ |
1,350 |
|
|
$ |
141 |
|
|
$ |
2,189 |
|
|
$ |
332 |
|
General and administrative |
|
|
1,751 |
|