Dyne Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Highlights


March 04, 2021

- Preclinical Data Further Validate FORCE™ Platform; Driving Toward IND Submissions for DM1, DMD and FSHD Programs Between Q4’21 and Q4’22 -

- Recent Appointments to Experienced Leadership Team Strengthen Company's Clinical Development Capabilities -

- Successful Financings Expected to Provide Cash Runway into the Second Half of 2024 -

WALTHAM, Mass., March 04, 2021 (GLOBE NEWSWIRE) -- 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 fourth quarter and full year 2020 and recent business highlights.

“2020 was a transformational year for Dyne. We delivered validating data for our FORCE™ platform and programs, further strengthened our exceptional team with the addition of highly experienced leaders and completed our IPO. Together with earlier financings in 2020 and the follow-on public offering completed in January 2021, we have raised more than $550 million, which we expect to support us into the second half of 2024. We begin 2021 focused on driving our DM1, DMD and FSHD programs to the clinic as we pursue our goal of delivering potentially life-transforming therapies to people living with serious muscle diseases,” said Joshua Brumm, president and chief executive officer of Dyne.

Recent Highlights

Upcoming Scientific & Investor Conference Presentations

Fourth Quarter and Full Year 2020 Financial Results

Cash position: Cash, cash equivalents and marketable securities were $345.3 million as of December 31, 2020. Additionally, in January 2021, Dyne completed a public offering of common stock, with gross proceeds totaling approximately $168 million.

Research and development (R&D) expenses: R&D expenses were $22.1 million and $4.3 million for the quarters ended December 31, 2020 and 2019, respectively. R&D expenses were $45.2 million and $11.0 million for the years ended December 31, 2020 and 2019, respectively.

General and administrative (G&A) expenses: G&A expenses were $6.5 million and $1.2 million for the quarters ended December 31, 2020 and 2019, respectively. G&A expenses were $13.4 million and $2.8 million for the years ended December 31, 2020 and 2019, respectively.

Net loss: Net loss for the quarter ended December 31, 2020 was $28.6 million, or $0.64 per basic and diluted share. This compares with a net loss of $5.4 million, or $2.10 per basic and diluted share, for the quarter ended December 31, 2019. Net loss for the year ended December 31, 2020 was $59.4 million, or $4.13 per basic and diluted share. This compares with a net loss of $14.9 million, or $6.08 per basic and diluted share, for the year ended December 31, 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’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs 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 TwitterLinkedIn 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, plans, objectives of management, the expected timeline for submitting investigational new drug applications and achieving proof-of-concept data readouts 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 and clinical trials; the timing of and Dyne’s ability to submit investigational new drug applications; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; uncertainties related to Dyne’s ability to obtain sufficient cash resources to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements for the anticipated periods; 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 Annual Report on Form 10-K for the year ended December 31, 2020 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.

Contact:

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

Dyne Therapeutics, Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share data)
                 
    Three Months Ended December 31,   Year Ended December 31,
      2020       2019       2020       2019  
Operating expenses:                
Research and development   $ 22,098     $ 4,259     $ 45,200     $ 11,040  
General and administrative     6,502       1,211       13,447       2,786  
Total operating expenses     28,600       5,470       58,647       13,826  
Loss from operations     (28,600 )     (5,470 )     (58,647 )     (13,826 )
Other (expense) income     (49 )     67       (790 )     (1,033 )
Net loss   $ (28,649 )   $ (5,403 )   $ (59,437 )   $ (14,859 )
Net loss per share—basic and diluted   $ (0.64 )   $ (2.10 )   $ (4.13 )   $ (6.08 )
Weighted-average common shares outstanding used in net loss per share—basic and diluted     45,058,494       2,567,007       14,395,955       2,442,872  
                                 

Dyne Therapeutics, Inc.
Condensed Consolidated Balance Sheet Data
(in thousands)
         
    December 31,   December 31,
    2020   2019
Assets        
Cash, cash equivalents and marketable securities   $ 345,314   $ 14,632
Other assets     8,020     1,804
Total assets   $ 353,334   $ 16,436
Liabilities and Stockholders’ Equity        
Liabilities     10,967     2,400
Stockholders’ equity     342,367     14,036
Total liabilities and stockholders’ equity   $ 353,334   $ 16,436
             


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