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 4, 2021, Dyne Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended September 30, 2021. 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 4, 2021 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 4, 2021 |
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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 2021 Financial Results and Business Highlights
- Robust In Vivo Data Presented at Scientific Meetings Support Advancement of Dyne’s Co-lead Candidates into the Clinic -
- Investigational New Drug (IND) Submissions Anticipated for DYNE-251 in DMD During the Fourth Quarter of 2021 and for DYNE-101 in DM1 During the First Quarter of 2022 -
WALTHAM, Mass., November 4, 2021– Dyne Therapeutics, Inc. (Nasdaq: DYN), a 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 2021 and business highlights.
“We made tremendous progress during the third quarter and are now preparing to advance Dyne’s two co-lead programs into the clinic, with the IND submission for DYNE-251 in DMD anticipated during the fourth quarter of 2021, followed by the IND submission for DYNE-101 in DM1 expected in the first quarter of 2022,” said Joshua Brumm, president and chief executive officer of Dyne. “As we highlighted at our recent R&D Day and presentations at the World Muscle Society and Muscle Study Group meetings, we have generated robust in vivo data for these programs. The team has also done extensive work to engage with multiple stakeholders, including thought leaders, regulators, advocacy groups and patients to prepare to move both candidates into the clinic. The FORCE™ platform is exhibiting powerful potential to address these rare muscle diseases where patients have few or no therapeutic options, and I’m proud that the Dyne team remains fully focused on urgently delivering on our mission.”
Recent Highlights
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Upcoming Events and Milestones
Third Quarter 2021 Financial Results
Cash position: Cash, cash equivalents and marketable securities were $407.5 million as of September 30, 2021, which is anticipated to fund operations into the second half of 2024.
Research and development (R&D) expenses: R&D expenses were $36.5 million for the third quarter of 2021 compared to $9.7 million for the third quarter of 2020.
General and administrative (G&A) expenses: G&A expenses were $6.3 million during the third quarter of 2021 compared to $3.8 million for the third quarter of 2020.
Net loss: Net loss was $42.6 million or $0.83 per share of common stock for the third quarter of 2021 compared to $13.9 million, or $2.01 per share of common stock for the third quarter of 2020.
About Dyne Therapeutics
Dyne Therapeutics is building a leading muscle disease company dedicated to 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 therapeutic candidates for serious muscle diseases, including 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.
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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 expected timeline for submitting investigational new drug applications and dosing patients in trials, the anticipated design of the trials and the sufficiency of its cash resources, 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 conduct of research activities and the initiation and completion of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies; the timing of and Dyne’s ability to submit and obtain regulatory clearance for investigational new drug applications and initiate clinical trials; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; whether investigators and regulatory agencies will agree with the design of Dyne’s planned 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 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.
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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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2021 |
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2020 |
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2021 |
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2020 |
Operating expenses: |
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Research and development |
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$ 36,510 |
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$ 9,679 |
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$ 79,007 |
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$ 23,102 |
General and administrative |
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6,256 |
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3,841 |
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19,058 |
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6,945 |
Total operating expenses |
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42,766 |
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13,520 |
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98,065 |
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30,047 |
Loss from operations |
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(42,766) |
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(13,520) |
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(98,065) |
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(30,047) |
Other (expense) income, net |
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184 |
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(400) |
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560 |
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(741) |
Net loss |
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$ (42,582) |
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$ (13,920) |
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$ (97,505) |
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$ (30,788) |
Net loss per share—basic and diluted |
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$ (0.83) |
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$ (2.01) |
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$ (1.92) |
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$ (7.51) |
Weighted-average common shares outstanding |
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51,320,940 |
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6,920,008 |
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50,676,668 |
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4,100,504 |
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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2021 |
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2020 |
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Assets |
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Cash, cash equivalents and marketable securities |
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$ 407,523 |
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$ 345,314 |
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Other assets |
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59,355 |
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8,020 |
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Total assets |
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$ 466,878 |
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$ 353,334 |
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Liabilities and Stockholders’ Equity |
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Liabilities |
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52,762 |
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10,967 |
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Stockholders’ equity |
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414,116 |
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342,367 |
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Total liabilities and stockholders’ equity |
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$ 466,878 |
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$ 353,334 |
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Contact:
Dyne Therapeutics
Amy Reilly
areilly@dyne-tx.com
857-341-1203
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