Dyne Therapeutics(DYN) - 2023 Q2 - Quarterly Report

Financial Performance - For the three months ended June 30, 2023, total operating expenses increased to $66.736 million from $52.755 million in the same period of 2022, representing a change of $13.981 million[79]. - The net loss for the three months ended June 30, 2023, was $64.902 million, compared to a net loss of $52.304 million in the same period of 2022, reflecting an increase of $12.598 million[79]. - The company reported a significant operating loss of $64.9 million for the three months ended June 30, 2023[60]. - The net loss for the six months ended June 30, 2023, was $109.1 million, an increase of $21.2 million (24.1%) compared to a net loss of $87.9 million in 2022[86]. - Net cash used in operating activities for the six months ended June 30, 2023, was $102.6 million, compared to $81.6 million in 2022, an increase of $21.0 million (25.7%)[94]. Research and Development - Research and development expenses for the three months ended June 30, 2023, were $59.130 million, up from $46.664 million in 2022, an increase of $12.466 million[79]. - Total research and development expenses for the six months ended June 30, 2023, were $96.7 million, an increase of $21.8 million (29.0%) compared to $74.9 million in the same period of 2022[87]. - Direct research and development expenses for DYNE-101 increased to $26.9 million in the six months ended June 30, 2023, up by $11.2 million (71.4%) from $15.7 million in 2022[87]. - The European Medicines Agency granted orphan drug designation to DYNE-101 for the treatment of DM1 in May 2023[54]. - The U.S. Food and Drug Administration granted orphan drug and rare pediatric designations to DYNE-251 for the treatment of DMD in March 2023[56]. - The company anticipates reporting initial data on safety and tolerability from the MAD portion of the DYNE-101 trial in the second half of 2023[53]. Cash and Financing - Cash, cash equivalents, and marketable securities as of June 30, 2023, amounted to $207.7 million[92]. - Net cash provided by financing activities for the six months ended June 30, 2023, was $53.7 million, primarily from the sale of common stock under the at-the-market offering program[97]. - The company issued and sold 4,509,063 shares of common stock for aggregate net proceeds of $52.4 million during the six months ended June 30, 2023, at a weighted average price of $12.01 per share[93]. - The company expects its existing cash, cash equivalents, and marketable securities to fund operating expenses and capital expenditures through 2024[99]. - The company anticipates generating substantial product revenue in the future, financing cash needs through equity offerings, debt financings, and collaborations[100]. Operating Expenses - The company expects to continue incurring significant expenses and increasing operating losses in the foreseeable future[61]. - General and administrative expenses for the six months ended June 30, 2023, totaled $15.5 million, reflecting an increase of $1.9 million (13.9%) from $13.6 million in 2022[89]. - The increase in personnel-related expenses in general and administrative functions was primarily due to increased headcount, resulting in a rise of $850,000 (22.3%) in expenses for the six months ended June 30, 2023[89]. Accounting Policies - The company defines critical accounting policies that require subjective estimates, particularly regarding accrued research and development expenses and stock-based compensation[106]. - There have been no significant changes to the company's critical accounting policies or estimates since the last annual report filed on March 2, 2023[107]. - The company is classified as an "emerging growth company" and a "smaller reporting company," allowing it to take advantage of certain reporting exemptions until December 31, 2025[109]. Lease and Licensing Agreements - The company has a lease agreement for office and laboratory space with a base rent obligation starting at $0.4 million per month, increasing to $0.5 million per month[103]. - The company has entered into a license agreement with the University of Mons, with payment obligations contingent on achieving specified development and commercial milestones[102].