Financial Performance - For the three months ended March 31, 2024, the company reported a net loss of $65.6 million, compared to a net loss of $44.2 million for the same period in 2023[76]. - As of March 31, 2024, the company had an accumulated deficit of $698.2 million[76]. - Total operating expenses for Q1 2024 were $69.2 million, an increase of 52% compared to $45.5 million in Q1 2023[94]. - Net loss for Q1 2024 was $65.6 million, an increase of 48% from a net loss of $44.2 million in Q1 2023[94]. - Research and development expenses rose to $44.5 million in Q1 2024, up from $37.5 million in Q1 2023, reflecting a 19% increase[95]. - General and administrative expenses surged to $24.6 million in Q1 2024, compared to $7.9 million in Q1 2023, marking a 210% increase[97]. - Net cash used in operating activities was $78.5 million in Q1 2024, compared to $46.9 million in Q1 2023[106]. - Interest income increased to $3.0 million in Q1 2024 from $1.5 million in Q1 2023, representing a 100% increase[99]. Clinical Development - The company plans to initiate registrational cohorts for DYNE-101 and DYNE-251 by the end of 2024, following the completion of enrollment in their respective clinical trials[67][72]. - Initial clinical data from the ACHIEVE trial for DYNE-101 showed a favorable safety profile with no serious treatment-emergent adverse events identified[66]. - In the DELIVER trial for DYNE-251, initial data indicated that dystrophin expression levels exceeded those reported in a third-party clinical trial with a 24-fold lower total PMO dose[70]. - The majority of treatment-emergent adverse events in both trials were mild or moderate, with no clinically meaningful changes observed in kidney or liver parameters[66][71]. Cash and Funding - The company believes its existing cash, cash equivalents, and marketable securities will fund its operating expenses through 2025[80]. - Cash, cash equivalents, and marketable securities totaled $453.5 million as of March 31, 2024[101]. - The company expects to fund its operating expenses and capital expenditures through 2025 based on current cash reserves[111]. - The company issued 19,722,500 shares in a follow-on public offering in January 2024, generating net proceeds of $323.9 million[105]. - The company expects to finance cash needs through equity offerings, debt financings, collaborations, and licensing arrangements, which may dilute stockholder ownership[112]. Operational Commitments - The lease agreement for office and laboratory space has a term of 8.5 years, with base rent starting at $0.4 million per month, increasing to $0.5 million per month[115]. - The company has entered into a license agreement with the University of Mons, with payment obligations contingent on achieving specified milestones and generating product sales[114]. - The company has contractual obligations with CROs and CMOs for research and manufacturing services, which are generally cancelable with written notice[113]. Accounting and Compliance - The company is classified as an "emerging growth company" and may take advantage of exemptions from certain reporting requirements until December 31, 2025[121]. - The company has critical accounting policies related to accrued research and development expenses and stock-based compensation, which are expected to be increasingly important as product candidates advance[118]. - There have been no significant changes to critical accounting policies or estimates since the last Annual Report filed on March 5, 2024[119]. - There are no recently issued accounting pronouncements expected to materially impact the financial statements as of March 31, 2024[120]. Risks and Estimates - The company expects to incur significant expenses and increasing operating losses for the foreseeable future as it advances its clinical programs[76]. - The company may face risks associated with substantial capital requirements, including the inability to raise additional funds or enter into favorable agreements[112]. - The company evaluates estimates and assumptions on an ongoing basis, with actual results potentially differing from estimates under different conditions[117].

WALTHAM, Mass., March 13, 2024 (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 announced that management is scheduled to participate in a fireside chat at the Stifel 2024 Virtual CNS Days on Wednesday, March 20, 2024 at 8:30 a.m. ET. A live webcast will be available in the Investors & Media section of Dyne’s website at https://investors. ...

WALTHAM, Mass., March 13, 2024 (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 announced that management is scheduled to participate in a fireside chat at the Stifel 2024 Virtual CNS Days on Wednesday, March 20, 2024 at 8:30 a.m. ET. A live webcast will be available in the Investors & Media section of Dyne's website at https://investors.d ...

Pakin Jarerndee/iStock via Getty Images Dyne Therapeutics, Inc. (NASDAQ:DYN) is advancing the use of its FORCE platform to target skeletal muscle disorders. This would be with the use of modern oligonucleotide technology drugs like DYNE-101 and DYNE-251, which are both being advanced for the treatment of patients with myotonic dystrophy type 1 [DM1] and Duchenne Muscular Dystrophy [DMD] with specific exon skipping mutations. The DYNE-101 candidate is being advanced for the treatment of patients with DM1 in ...

- Positive Initial Clinical Data from ACHIEVE Trial in DM1 Patients and DELIVER Trial in DMD Patients Demonstrated Proof-of-Concept, Validating the Promise of the FORCE™ Platform and Targeted Delivery to Muscle - - Strengthened Balance Sheet with $345 Million Public Offering Extending Projected Cash Runway Through 2025 - WALTHAM, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeuti ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39509 Dyne Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 36-4883909 (State or other jurisdictio ...

Exhibit 99.1 Dyne Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Highlights - Positive Initial Clinical Data from ACHIEVE Trial in DM1 Patients and DELIVER Trial in DMD Patients Demonstrated Proof-of-Concept, Validating the Promise of the FORCE™ Platform and Targeted Delivery to Muscle - - Strengthened Balance Sheet with $345 Million Public Offering Extending Projected Cash Runway Through 2025 - WALTHAM, Mass., March 5, 2024 – Dyne Therapeutics, Inc. (Nasdaq: DY ...

WALTHAM, Mass., Feb. 01, 2024 (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 announced that management is scheduled to present at the following investor conferences in February: Guggenheim Healthcare Talks | 6th Annual Biotechnology Conference, fireside chat on Thursday, February 8, 2024 at 11:00 a.m. ET in New York Oppenheimer 34th Annua ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________ Commission File Number: 001-39509 Dyne Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delawa ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________ Commission File Number: 001-39509 (Registrant's telephone number, including area code) Securities registered pursuant to Sec ...