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Dyne Therapeutics Reports Third Quarter 2023 Financial Results and Provides Update on Significant Progress for ACHIEVE and DELIVER Trials and Upcoming Clinical Milestones


October 30, 2023

- 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., Oct. 30, 2023 (GLOBE NEWSWIRE) -- 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

Planned Reporting of Initial Data

DELIVER Trial of DYNE-251 in DMD

Clinical Update

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,” “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.  
Condensed Consolidated Statement of Operations (Unaudited)  
(in thousands, except share and per share data)  
                         
    Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
    2023     2022     2023     2022  
Operating expenses:                        
Research and development   $ 55,251     $ 34,670     $ 151,918     $ 109,570  
General and administrative     7,022       7,609       22,556       21,247  
Total operating expenses     62,273       42,279       174,474       130,817  
Loss from operations     (62,273 )     (42,279 )     (174,474 )     (130,817 )
Other (expense) income, net     2,063       894       5,175       1,545  
Net loss   $ (60,210 )   $ (41,385 )   $ (169,299 )   $ (129,272 )
Net loss per share—basic and diluted   $ (0.99 )   $ (0.80 )   $ (2.86 )   $ (2.50 )
Weighted-average common shares outstanding used in net
   loss per share—basic and diluted
    61,109,917       51,795,446       59,107,795       51,692,899  

   
   
Dyne Therapeutics, Inc.  
Condensed Consolidated Balance Sheet Data (Unaudited)  
(in thousands)  
           
    September 30,   December 31,  
    2023   2022  
Assets          
Cash, cash equivalents and marketable securities   $ 157,823   $ 256,012  
Other assets     47,421     50,313  
Total assets   $ 205,244   $ 306,325  
Liabilities and Stockholders’ Equity          
Liabilities     53,206     53,961  
Stockholders’ equity     152,038     252,364  
Total liabilities and stockholders’ equity   $ 205,244   $ 306,325  


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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