DYN 8-K
Dyne Therapeutics, Inc. (DYN)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported):
(Exact Name of Registrant as Specified in Charter)
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
|
|
|
||
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s telephone number, including area code: (
Not applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading symbol(s) |
|
Name of each exchange on which registered |
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On August 12, 2024, Dyne Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended June 30, 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. |
|
Description |
|
|
|
99.1 104 |
|
Press Release issued by Dyne Therapeutics, Inc. on August 12, 2024 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.
|
|
|
|
|
|
|
|
|
DYNE THERAPEUTICS, INC. |
||||
|
|
|
||||
Date: August 12, 2024 |
|
By: |
|
/s/ John G. Cox |
||
|
|
|
|
Name: |
|
John G. Cox |
|
|
|
|
Title: |
|
President and Chief Executive Officer |
Exhibit 99.1
Dyne Therapeutics Reports Second Quarter 2024 Financial Results
and Recent Business Highlights
- Recent Data from ACHIEVE Trial of DYNE-101 in DM1 and DELIVER Trial of DYNE-251 in DMD Demonstrated Compelling Impact on Key Disease Biomarkers and Improvement in Multiple Functional Endpoints -
- Strengthened Balance Sheet with $374 Million Public Offering Extending Projected Cash Runway At Least Into the Second Half of 2026 -
WALTHAM, Mass., August 12, 2024 – Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today reported financial results for the second quarter of 2024 and recent business highlights.
“The second quarter of 2024 was an exciting one for our clinical programs and pipeline. We reported new clinical data from our ACHIEVE and DELIVER trials, demonstrating meaningful impact on key biomarkers and functional improvements that reflect best-in-class potential. We are evaluating the clinical profile of different dose and dose regimens with the goal of transforming treatment for individuals living with DM1 and DMD. Based on our compelling clinical data and productive regulatory interactions, we continue to pursue expedited approval pathways and plan to provide an update on the path to registration for both programs by year-end,” said John Cox, Dyne’s president and chief executive officer. “Additionally, we highlighted the modularity of our FORCE™ platform with the presentation of robust preclinical data supporting our FSHD program, and for the first time, showed the ability of our platform to deliver enzyme replacement therapy to muscle and CNS in a Pompe disease model. We also strengthened our balance sheet to support the promise of our portfolio.”
Recent Highlights and Anticipated Milestones
Phase 1/2 ACHIEVE Trial of DYNE-101 in myotonic dystrophy type 1 (DM1)
1
Phase 1/2 DELIVER Trial of DYNE-251 in DMD
Path to Registration for ACHIEVE & DELIVER Trials
FORCE™ Platform and Pipeline
Other Business Highlights
2
Second Quarter 2024 Financial Results
Cash position: Cash, cash equivalents and marketable securities were $778.8 million as of June 30, 2024, which is anticipated to fund operations at least into the second half of 2026.
Research and development (R&D) expenses: R&D expenses were $62.3 million for the quarter ended June 30, 2024, compared to $59.1 million for the quarter ended June 30, 2023.
General and administrative (G&A) expenses: G&A expenses were $9.7 million for the quarter ended June 30, 2024, compared to $7.6 million for the quarter ended June 30, 2023.
Net loss: Net loss for the quarter ended June 30, 2024, was $65.1 million, or $0.70 per basic and diluted share. This compares with a net loss of $64.9 million, or $1.08 per basic and diluted share, for the quarter ended June 30, 2023.
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 anticipated timelines for reporting additional data from the ACHIEVE and DELIVER clinical trials and initiating registrational cohorts, expectations regarding the timing and outcome of interactions with global regulatory authorities and the availability of accelerated approval pathways for DYNE-101 and DYNE-251, expectations regarding the initiation of additional preclinical studies or clinical trials of DYNE-302 or, the anticipated timelines for reporting additional data for DYNE-302 or, expectations as to the relationship between data from the company’s ongoing ACHIEVE clinical trial in DM1 and DELIVER clinical trial in DMD and existing or additional data for DYNE-302 the sufficiency of Dyne’s cash resources for the period anticipated, and plans to provide future updates on pipeline programs, 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
3
clinical trials; whether results from preclinical studies and initial data from early clinical trials will be predictive of the final results of the clinical trials or future trials; 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 the regulatory approval process; 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-Q 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. |
|
|||||||||||||||
Condensed Consolidated Statement of Operations (Unaudited) |
|
|||||||||||||||
(in thousands, except share and per share data) |
|
|||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
62,263 |
|
|
$ |
59,130 |
|
|
$ |
106,802 |
|
|
$ |
96,667 |
|
General and administrative |
|
|
9,699 |
|
|
|
7,606 |
|
|
|
34,317 |
|
|
|
15,533 |
|
Total operating expenses |
|
|
71,962 |
|
|
|
66,736 |
|
|
|
141,119 |
|
|
|
112,200 |
|
Loss from operations |
|
|
(71,962 |
) |
|
|
(66,736 |
) |
|
|
(141,119 |
) |
|
|
(112,200 |
) |
Other income (expense), net |
|
|
6,860 |
|
|
|
1,834 |
|
|
|
10,368 |
|
|
|
3,111 |
|
Net loss |
|
$ |
(65,102 |
) |
|
$ |
(64,902 |
) |
|
$ |
(130,751 |
) |
|
$ |
(109,089 |
) |
Net loss per share—basic and diluted |
|
$ |
(0.70 |
) |
|
$ |
(1.08 |
) |
|
$ |
(1.51 |
) |
|
$ |
(1.88 |
) |
Weighted average common shares outstanding used in net |
|
|
92,507,815 |
|
|
|
59,835,087 |
|
|
|
86,777,150 |
|
|
|
58,090,142 |
|
Dyne Therapeutics, Inc. |
|
|||||||
Condensed Consolidated Balance Sheet Data (Unaudited) |
|
|||||||
(in thousands) |
|
|||||||
|
|
|
|
|
|
|
||
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
Assets |
|
|
|
|
|
|
||
Cash, cash equivalents and marketable securities |
|
$ |
778,838 |
|
|
$ |
123,100 |
|
Other assets |
|
|
47,046 |
|
|
|
41,982 |
|
Total assets |
|
$ |
825,884 |
|
|
$ |
165,082 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
||
Liabilities |
|
|
50,691 |
|
|
|
73,790 |
|
Stockholders’ equity |
|
|
775,193 |
|
|
|
91,292 |
|
Total liabilities and stockholders’ equity |
|
$ |
825,884 |
|
|
$ |
165,082 |
|
4
Contacts:
Investors
Amy Reilly
[email protected]
857-341-1203
Media
Stacy Nartker
[email protected]
781-317-1938
5