DYN 8-K
Dyne Therapeutics, Inc. (DYN)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On February 27, 2025, Dyne Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the year ended December 31, 2024. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filling.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
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99.1 104 |
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Press Release issued by Dyne Therapeutics, Inc. on February 27, 2025 Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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DYNE THERAPEUTICS, INC. |
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Date: February 27, 2025 |
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By: |
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/s/ John G. Cox |
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Name: |
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John G. Cox |
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Title: |
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President and Chief Executive Officer |
Exhibit 99.1
Dyne Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights
- Received FDA Fast Track Designation for DYNE-101 in DM1 -
- Full enrollment of Registrational Expansion Cohort of ACHIEVE Trial of DYNE-101 in DM1 Planned for Mid-2025 to Support Submission for U.S. Accelerated Approval -
- Full Enrollment of Registrational Expansion Cohort of DELIVER Trial of DYNE-251 in DMD Planned for Q1 2025 to Support Submission for U.S. Accelerated Approval -
WALTHAM, Mass., February 27, 2025 – Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage neuromuscular disease company focused on advancing life-transforming therapeutics for people living with genetically driven diseases, today reported financial results for the fourth quarter and full year 2024 and recent business highlights.
“Our most recent clinical data for DYNE-101 from the ACHIEVE trial in DM1 patients showed substantial functional benefit, including the reversal of disease progression and improvement across a range of clinical measures, as well as a favorable safety profile. We believe that the compelling benefits seen with DYNE-101 result from addressing the underlying biology of this devastating neuromuscular disease through meaningful splicing correction,” said John Cox, president and chief executive officer of Dyne. “With these results in hand, we are moving rapidly to initiate a Registrational Expansion Cohort to support a potential submission for U.S. Accelerated Approval. Furthermore, in DMD, we expect data from the ongoing DELIVER trial of DYNE-251 in late 2025 to support a potential submission for U.S. Accelerated Approval in early 2026, giving us the transformational opportunity to launch two important therapies in 2027.”
DYNE-101 in DM1
DYNE-251 in DMD
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Fourth Quarter and Full Year 2024 Financial Results
Cash position: Cash, cash equivalents and marketable securities were $642.3 million as of December 31, 2024. During the first quarter of 2025, the Company received net proceeds of approximately $140.6 million from the sale of stock through its at-the-market offering program. The Company expects that its cash, cash equivalents and marketable securities as of December 31, 2024, together with the net proceeds from the Q1 2025 at-the-market offering, will be sufficient to fund its operations at least into the second half of 2026.
Research and development (R&D) expenses: R&D expenses were $81.8 million and $58.8 million for the quarters ended December 31, 2024 and 2023, respectively. R&D expenses were $281.4 million and $210.8 million for the years ended December 31, 2024 and 2023, respectively.
General and administrative (G&A) expenses: G&A expenses were $15.3 million and $8.8 million for the quarters ended December 31, 2024 and 2023, respectively. G&A expenses were $62.5 million and $31.4 million for the years ended December 31, 2024 and 2023, respectively.
Net loss: Net loss for the quarter ended December 31, 2024 was $89.5 million, or $0.88 per basic and diluted share. This compares with a net loss of $66.6 million, or $1.09 per basic and diluted share, for the quarter ended December 31, 2023. Net loss for the year ended December 31, 2024 was $317.4 million, or $3.37 per basic and diluted share. This compares with a net loss of $235.9 million, or $3.95 per basic and diluted share, for the year ended December 31, 2023.
About Dyne Therapeutics
Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE™ platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Dyne’s strategy, future operations, prospects and plans, objectives of management, the potential of the FORCE platform, the potential of DYNE-101 and DYNE-251, the anticipated timelines for reporting additional data from the ACHIEVE and DELIVER clinical trials, enrolling registrational cohorts and initiating additional clinical trials, the availability of
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expedited approval pathways for DYNE-101 and DYNE-251, expectations regarding the timing of submitting applications for U.S. Accelerated Approval, and the sufficiency of Dyne’s cash resources for the period anticipated, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Dyne may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the initiation and completion of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; the timing of and Dyne’s ability to enroll patients in clinical trials; whether results from preclinical studies and data from clinical trials will be predictive of the final results of the clinical trials or other trials; whether data from clinical trials will support submission for regulatory approvals; uncertainties as to the FDA’s and other regulatory authorities’ interpretation of the data from Dyne's clinical trials and acceptance of Dyne's clinical programs and as to the regulatory approval process for Dyne's product candidates; whether Dyne’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Dyne’s filings with the Securities and Exchange Commission (SEC), including the Company’s most recent Form 10-K and in subsequent filings Dyne may make with the SEC. In addition, the forward-looking statements included in this press release represent Dyne’s views as of the date of this press release. Dyne anticipates that subsequent events and developments will cause its views to change. However, while Dyne may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Dyne’s views as of any date subsequent to the date of this press release.
Dyne Therapeutics, Inc. |
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Condensed Consolidated Statement of Operations |
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(in thousands, except share and per share data) |
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Three Months Ended |
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Year Ended |
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December 31, |
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December 31, |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating expenses: |
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Research and development |
$ |
81,804 |
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$ |
58,843 |
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$ |
281,406 |
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$ |
210,762 |
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General and administrative |
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15,303 |
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8,846 |
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62,480 |
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31,400 |
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Total operating expenses |
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97,107 |
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67,689 |
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343,886 |
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242,162 |
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Loss from operations |
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(97,107 |
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(67,689 |
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(343,886 |
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(242,162 |
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Other (expense) income, net |
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7,567 |
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1,050 |
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26,468 |
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6,225 |
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Net loss |
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(89,540 |
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$ |
(66,639 |
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$ |
(317,418 |
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$ |
(235,937 |
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Net loss per share, basic and diluted |
$ |
(0.88 |
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$ |
(1.09 |
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$ |
(3.37 |
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$ |
(3.95 |
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Weighted average common shares outstanding, basic and diluted |
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101,982,168 |
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61,393,409 |
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94,143,565 |
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59,683,851 |
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Dyne Therapeutics, Inc. |
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Condensed Consolidated Balance Sheet Data |
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(in thousands) |
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December 31, |
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2024 |
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2023 |
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Assets |
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Cash, cash equivalents and marketable securities |
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$ |
642,268 |
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$ |
123,100 |
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Other assets |
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48,966 |
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41,982 |
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Total Assets |
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$ |
691,234 |
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$ |
165,082 |
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Liabilities and Stockholders’ Equity |
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Liabilities |
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61,396 |
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73,790 |
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Stockholders' equity |
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629,838 |
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91,292 |
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Total liabilities and stockholders' equity |
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$ |
691,234 |
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$ |
165,082 |
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Contacts:
Investors
Mia Tobias
[email protected]
781-317-0353
Media
Stacy Nartker
[email protected]
781-317-1938
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