- On Track to Submit INDs for DM1, DMD and FSHD Programs Between the Fourth Quarter of 2021 and the Fourth Quarter of 2022 -
- New In Vivo Data from DM1 and DMD Programs to be Presented at Scientific Meetings this Fall -
WALTHAM, Mass., Aug. 05, 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 second quarter 2021 and business highlights.
“We were pleased to present preclinical data from our DM1 and FSHD programs at scientific meetings during the quarter which further support our approach for addressing these devastating diseases, neither of which has any approved therapies,” said Joshua Brumm, president and chief executive officer of Dyne. “We remain on track to submit INDs for all three of our programs – DM1, DMD and FSHD – between the fourth quarter of 2021 and the fourth quarter of 2022. We have an exceptional team and the right resources to transition Dyne into a clinical stage company focused on bringing potentially life-transforming therapies to patients.”
Upcoming Events and Presentations
Second Quarter 2021 Financial Results
Cash position: Cash, cash equivalents and marketable securities were $435.6 million as of June 30, 2021, which is anticipated to fund operations into the second half of 2024.
Research and development (R&D) expenses: R&D expenses were $23.9 million for the second quarter of 2021 compared to $7.3 million for the second quarter of 2020.
General and administrative (G&A) expenses: G&A expenses were $6.3 million during the second quarter of 2021 compared to $1.3 million for the second quarter of 2020.
Net loss: Net loss was $30.0 million or $0.58 per common share for the second quarter of 2021 compared to $9.0 million, or $3.31 per common share for the second 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’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 Twitter, LinkedIn and Facebook.
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 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 June 30,||Six Months Ended June 30,|
|Research and development||$||23,872||$||7,334||$||42,496||$||13,423|
|General and administrative||6,293||1,341||12,802||3,105|
|Total operating expenses||30,165||8,675||55,298||16,528|
|Loss from operations||(30,165||)||(8,675||)||(55,298||)||(16,528||)|
|Other (expense) income, net||210||(307||)||375||(340||)|
|Net loss per share—basic and diluted||$||(0.58||)||$||(3.31||)||$||(1.09||)||$||(6.31||)|
|Weighted-average common shares outstanding
used in net loss per share—basic and diluted
|Dyne Therapeutics, Inc.|
|Condensed Consolidated Balance Sheet Data (Unaudited)|
|June 30,||December 31,|
|Cash, cash equivalents and marketable securities||$||435,589||$||345,314|
|Liabilities and Stockholders’ Equity|
|Total liabilities and stockholders’ equity||$||467,147||$||353,334|