DYN Dyne Therapeutics Inc

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): November 12, 2024

 

Dyne Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware	001-39509	36-4883909
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
1560 Trapelo Road Waltham, Massachusetts		02451
(Address of Principal Executive Offices)		(Zip Code)

 

Registrant’s telephone number, including area code: (781) 786-8230

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
Common stock, $0.0001 par value per share		DYN		Nasdaq Global Select Market

 

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. ☐

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Item 2.02 Results of Operations and Financial Condition.

On November 12, 2024, Dyne Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended September 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 November 12, 2024 Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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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: November 12, 2024		By:		/s/ John G. Cox
				Name:		John G. Cox
				Title:		President and Chief Executive Officer

 

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Dyne Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update

- IND Application for DYNE-101 for DM1 Cleared by FDA -
 

- New Clinical Data from DYNE-101 ACHIEVE Trial Expected in Early January 2025 -

- Enrolling Registrational Cohort of DYNE-251 DELIVER Trial in DMD -

WALTHAM, Mass., November 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 third quarter of 2024 and provided a corporate update.

“We’ve made significant progress in our ACHIEVE and DELIVER trials. We are very pleased to have received IND clearance for DYNE-101 and plan to report in early January additional data from the ACHIEVE trial in DM1, including from the 6.8 mg/kg cohort, which will inform our go-forward dose and dose regimen. Based on the encouraging biomarker and functional data from the DELIVER trial of DYNE-251 in DMD, we are enrolling patients in a registrational cohort at 20 mg/kg. We continue to pursue expedited approval pathways for both DYNE-101 and DYNE-251,” said John Cox, president and chief executive officer of Dyne. “Our strong financial foundation positions us to advance our clinical programs as well as our pipeline to address the significant unmet needs of people living with neuromuscular diseases.”

 

ACHIEVE Trial of DYNE-101 in DM1

 

 

 

 

DELIVER Trial of DYNE-251 in DMD

 

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Third Quarter 2024 Financial Results

 

Cash position: Cash, cash equivalents and marketable securities were $723.7 million as of September 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 $92.8 million for the quarter ended September 30, 2024, compared to $55.3 million for the quarter ended September 30, 2023.

General and administrative (G&A) expenses: G&A expenses were $12.9 million for the quarter ended September 30, 2024, compared to $7.0 million for the quarter ended September 30, 2023.

Net loss: Net loss for the quarter ended September 30, 2024 was $97.1 million, or $0.96 per basic and diluted share. This compares with a net loss of $60.2 million, or $0.99 per basic and diluted share, for the quarter ended September 30, 2023.

 

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 potential of DYNE-101 and DYNE-251, the anticipated timelines for reporting additional data from the ACHIEVE and DELIVER clinical trials, the availability of expedited approval pathways for DYNE-101 and DYNE-251, expectations regarding the timing and outcome of interactions with global regulatory authorities, 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

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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 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 September 30,								Nine Months Ended September 30,
		2024				2023				2024				2023
Operating expenses:
Research and development		$	92,800			$	55,251			$	199,601			$	151,918
General and administrative			12,859				7,022				47,177				22,556
Total operating expenses			105,659				62,273				246,778				174,474
Loss from operations			(105,659	)			(62,273	)			(246,778	)			(174,474	)
Other income (expense), net			8,534				2,063				18,902				5,175
Net loss		$	(97,125	)		$	(60,210	)		$	(227,876	)		$	(169,299	)
Net loss per share—basic and diluted		$	(0.96	)		$	(0.99	)		$	(2.49	)		$	(2.86	)
Weighted average common shares outstanding used in net    loss per share—basic and diluted			100,882,042				61,109,917				91,511,621				59,107,795

 

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Dyne Therapeutics, Inc.
Condensed Consolidated Balance Sheet Data (Unaudited)
(in thousands)
		September 30,				December 31,
		2024				2023
Assets
Cash, cash equivalents and marketable securities		$	723,674			$	123,100
Other assets			45,170				41,982
Total assets		$	768,844			$	165,082
Liabilities and Stockholders’ Equity
Liabilities			63,304				73,790
Stockholders’ equity			705,540				91,292
Total liabilities and stockholders’ equity		$	768,844			$	165,082

 

 

Contacts:
 

Investors

Amy Reilly
areilly@dyne-tx.com
857-341-1203

 

Mike Hencke
Kendall Investor Relations
ir@dyne-tx.com

 

Media

Stacy Nartker
snartker@dyne-tx.com
781-317-1938

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v3.24.3

Document and Entity Information	Nov. 12, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 12, 2024
Entity Registrant Name	Dyne Therapeutics, Inc.
Entity Central Index Key	0001818794
Entity Incorporation, State or Country Code	DE
Entity File Number	001-39509
Entity Tax Identification Number	36-4883909
Entity Address, Address Line One	1560 Trapelo Road
Entity Address, City or Town	Waltham
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02451
City Area Code	781
Local Phone Number	786-8230
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Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common stock, $0.0001 par value per share
Trading Symbol	DYN
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Entity Ex Transition Period	false

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