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 October 30, 2023, Dyne Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended September 30, 2023. 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 October 30, 2023 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: October 30, 2023 |
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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 2023 Financial Results and Provides Update on Significant Progress for ACHIEVE and DELIVER Trials and Upcoming Clinical Milestones
- Initial ACHIEVE and DELIVER Data to be Presented at a Company Event Around the J.P. Morgan Healthcare Conference in Early January 2024, Including Safety, Biomarker of Splicing and Functional Outcome of Myotonia in DM1; Safety and Dystrophin Expression in DMD -
- ACHIEVE Trial of DYNE-101 in DM1 Fully Enrolled Through 3.4 mg/kg Cohort;
DELIVER Trial of DYNE-251 in DMD Fully Enrolled Through 10 mg/kg Cohort -
- Safety Profile in ACHIEVE and DELIVER Has Supported Dose Escalation to a Combined Nine Cohorts with Over 300 Doses Administered to Date -
WALTHAM, Mass., October 30, 2023 – 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 2023 and provided an update on progress and upcoming milestones for its Phase 1/2 ACHIEVE and DELIVER clinical trials.
“We’ve made tremendous progress in our ACHIEVE and DELIVER trials with more than 72 patients enrolled and over 300 doses administered thus far. To date, the safety profile in the clinic has been favorable for DYNE-101 and DYNE-251 and has supported dose escalation to a combined nine cohorts across both trials. The enthusiasm amongst the DM1 and DMD communities reflects the significant unmet need and the potential for our investigational therapies to deliver transformative outcomes for patients,” said Joshua Brumm, president and chief executive officer of Dyne. “We are moving with great excitement towards reporting initial data from ACHIEVE and DELIVER, including the important biomarker of splicing and functional outcome of myotonia in DM1 and dystrophin in DMD. We look forward to sharing both readouts around the time of the J.P. Morgan Healthcare Conference in early January 2024.”
ACHIEVE Trial of DYNE-101 in DM1
Clinical Update
1
Planned Reporting of Initial Data
DELIVER Trial of DYNE-251 in DMD
Clinical Update
2
Planned Reporting of Initial Data
Third Quarter 2023 Financial Results
Cash position: Cash, cash equivalents and marketable securities were $157.8 million as of September 30, 2023, which is anticipated to fund operations through 2024.
Research and development (R&D) expenses: R&D expenses were $55.3 million for the quarter ended September 30, 2023, compared to $34.7 million for the quarter ended September 30, 2022.
General and administrative (G&A) expenses: G&A expenses were $7.0 million for the quarter ended September 30, 2023, compared to $7.6 million for the quarter ended September 30, 2022.
Net loss: Net loss for the quarter ended September 30, 2023 was $60.2 million, or $0.99 per basic and diluted share. This compares with a net loss of $41.4 million, or $0.80 per basic and diluted share, for the quarter ended September 30, 2022.
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. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD). 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 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,”
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“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 and clinical trials 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; 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. |
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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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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
55,251 |
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$ |
34,670 |
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$ |
151,918 |
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$ |
109,570 |
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General and administrative |
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7,022 |
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7,609 |
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22,556 |
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21,247 |
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Total operating expenses |
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62,273 |
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42,279 |
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174,474 |
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130,817 |
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Loss from operations |
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(62,273 |
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(42,279 |
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(174,474 |
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(130,817 |
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Other (expense) income, net |
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2,063 |
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894 |
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5,175 |
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1,545 |
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Net loss |
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$ |
(60,210 |
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$ |
(41,385 |
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$ |
(169,299 |
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$ |
(129,272 |
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Net loss per share—basic and diluted |
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$ |
(0.99 |
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$ |
(0.80 |
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$ |
(2.86 |
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$ |
(2.50 |
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Weighted-average common shares outstanding used in net |
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61,109,917 |
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51,795,446 |
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59,107,795 |
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51,692,899 |
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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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2023 |
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2022 |
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Assets |
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Cash, cash equivalents and marketable securities |
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$ |
157,823 |
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$ |
256,012 |
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Other assets |
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47,421 |
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50,313 |
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Total assets |
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$ |
205,244 |
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$ |
306,325 |
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Liabilities and Stockholders’ Equity |
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Liabilities |
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53,206 |
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53,961 |
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Stockholders’ equity |
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152,038 |
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252,364 |
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Total liabilities and stockholders’ equity |
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$ |
205,244 |
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$ |
306,325 |
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Contacts:
Investors
Amy Reilly
areilly@dyne-tx.com
857-341-1203
Media
Stacy Nartker
snartker@dyne-tx.com
781-317-1938
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