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 November 3, 2022, Dyne Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended September 30, 2022. 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 November 3, 2022 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: November 3, 2022 |
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By: |
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/s/ Joshua Brumm |
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Name: |
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Joshua Brumm |
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Title: |
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President and Chief Executive Officer |
Exhibit 99.1
Dyne Therapeutics Reports Third Quarter 2022 Financial Results and Business Highlights
- DYNE-101 ACHIEVE and DYNE-251 DELIVER Clinical Trials Underway with Data Anticipated in the Second Half of 2023 -
WALTHAM, Mass., November 3, 2022 – 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 third quarter of 2022 and business highlights.
“In the third quarter of 2022 we marked incredibly important milestones for Dyne with the initiation of patient clinical trials for our two lead product candidates, DYNE-101 and DYNE-251. Individuals living with DM1 and DMD are in urgent need of new and better therapeutic options. We are inspired by these communities and the clinicians treating them and are grateful for their input and support,” said Joshua Brumm, president and chief executive officer of Dyne. “We are focused on executing on our global trials, ACHIEVE and DELIVER, which are designed to be registrational, and driving towards meaningful clinical data readouts from both anticipated in the second half of 2023.”
Business Highlights
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Upcoming Investor Conferences
Management is scheduled to present at the following investor conferences in November:
A live webcast of each presentation will be available in the Investors & Media section of Dyne’s website at https://investors.dyne-tx.com/news-and-events/events-and-presentations and a replay will be accessible for 90 days.
Third Quarter 2022 Financial Results
Cash position: Cash, cash equivalents and marketable securities were $248.1 million as of September 30, 2022, which is anticipated to fund operations through 2024.
Research and development (R&D) expenses: R&D expenses were $34.7 million for the quarter ended September 30, 2022, compared to $36.5 million for the quarter ended September 30, 2021.
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General and administrative (G&A) expenses: G&A expenses were $7.6 million for the quarter ended September 30, 2022, compared to $6.3 million for the quarter ended September 30, 2021.
Net loss: Net loss for the quarter ended September 30, 2022 was $41.4 million, or $0.80 per basic and diluted share. This compares with a net loss of $42.6 million, or $0.83 per basic and diluted share, for the quarter ended September 30, 2021.
About Dyne Therapeutics
Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne has a broad portfolio of programs for serious muscle diseases, including candidates for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on Twitter, 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 anticipated timelines for reporting data from the DYNE-251 and DYNE-101 clinical trials, the trial design of the DYNE-251 and DYNE-101 clinical trials, and the sufficiency of Dyne’s existing 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 initiate and enroll patients in clinical trials; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; whether Dyne’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties associated with the impact of the COVID-19 pandemic on Dyne’s business and operations; 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
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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 (Unaudited) |
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(in thousands, except share and per share data) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Operating expenses: |
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Research and development |
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$ |
34,670 |
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$ |
36,510 |
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$ |
109,570 |
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$ |
79,007 |
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General and administrative |
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7,609 |
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6,256 |
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21,247 |
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19,058 |
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Total operating expenses |
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42,279 |
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42,766 |
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130,817 |
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98,065 |
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Loss from operations |
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(42,279 |
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(42,766 |
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(130,817 |
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(98,065 |
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Other (expense) income, net |
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894 |
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184 |
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1,545 |
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560 |
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Net loss |
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$ |
(41,385 |
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$ |
(42,582 |
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$ |
(129,272 |
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$ |
(97,505 |
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Net loss per share—basic and diluted |
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$ |
(0.80 |
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$ |
(0.83 |
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$ |
(2.50 |
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$ |
(1.92 |
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Weighted-average common shares outstanding used in net |
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51,795,446 |
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51,320,940 |
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51,692,899 |
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50,676,668 |
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Dyne Therapeutics, Inc. |
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Condensed Consolidated Balance Sheet Data (Unaudited) |
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(in thousands) |
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September 30, |
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December 31, |
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2022 |
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2021 |
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Assets |
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Cash, cash equivalents and marketable securities |
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$ |
248,142 |
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$ |
376,571 |
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Other assets |
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51,537 |
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49,092 |
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Total assets |
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$ |
299,679 |
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$ |
425,663 |
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Liabilities and Stockholders’ Equity |
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Liabilities |
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49,935 |
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57,466 |
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Stockholders’ equity |
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249,744 |
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368,197 |
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Total liabilities and stockholders’ equity |
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$ |
299,679 |
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$ |
425,663 |
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Contact:
Investors
Amy Reilly
areilly@dyne-tx.com
857-341-1203
Media
Stacy Nartker
snartker@dyne-tx.com
781-317-1938
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