Financial Position - The company has an accumulated deficit of $146.7 million as of March 31, 2025, and expects to continue generating operating losses and negative cash flows for the foreseeable future[95]. - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $382.5 million, which is projected to fund operations into the second quarter of 2027[99]. - Cash, cash equivalents, and marketable securities totaled $382.5 million as of March 31, 2025, with an accumulated deficit of $146.7 million[125]. - Net cash used in operating activities was $38.5 million for Q1 2025, compared to $25.5 million in Q1 2024, driven by a net loss and changes in operating assets and liabilities[128][129]. - The company anticipates that its cash resources will be sufficient to fund operations into the second quarter of 2027 based on current operating plans[134]. Revenue and Expenses - Collaboration revenue decreased to $20.6 million for the three months ended March 31, 2025, from $59.1 million in the same period of 2024, primarily due to a $38.7 million cumulative catch-up adjustment in 2024[118]. - Total operating expenses increased to $42.3 million in Q1 2025 from $38.0 million in Q1 2024, with research and development expenses rising by $3.5 million to $32.1 million[117][120]. - Net loss for the three months ended March 31, 2025, was $17.3 million, compared to a net income of $23.5 million in the same period of 2024, reflecting a change of $40.8 million[117]. - General and administrative expenses increased to $10.3 million in Q1 2025 from $9.4 million in Q1 2024, primarily due to increased personnel costs[121]. - Total interest and other income increased to $4.4 million in Q1 2025 from $4.2 million in Q1 2024, driven by higher interest income from investments[122]. Clinical Development and Strategic Plans - The company plans to initiate three clinical trials by year-end 2025 for its DMD franchise, including ENTR-601-44, ENTR-601-45, and ENTR-601-50[92]. - The company received authorization from the FDA to lift the clinical hold on ENTR-601-44 and plans to initiate a Phase 1b MAD clinical study in adult DMD patients in the first half of 2026[93]. - A new strategic plan was announced on April 29, 2025, focusing on DMD clinical candidates and reducing the workforce by approximately 20%[93]. - The company expects to incur significant expenses related to developing internal commercialization capabilities if any therapeutic candidates receive regulatory approval[95]. - The company has positive preclinical data for programs outside its neuromuscular franchise and plans to share its first clinical candidate in ocular disease later in 2025[94]. Growth Strategy and Market Risks - The company is focused on acquiring or in-licensing products, intellectual property, and technologies as part of its growth strategy[141]. - The company has added operational, financial, and management information systems to support product development[141]. - The company qualifies as an "emerging growth company" under the JOBS Act, allowing for delayed adoption of new accounting standards until certain revenue thresholds are met[140]. - The company will no longer qualify as a "smaller reporting company" effective December 31, 2024, impacting its reporting requirements[143]. - The company is exposed to interest rate market risk, but changes in interest rates have not materially impacted its financial position to date[145][146]. - Inflation has not had a material effect on the company's results of operations during the periods presented[147]. - The company is exposed to foreign currency exchange risk but has not experienced material effects from fluctuations to date[150]. Operational Adjustments - The company intends to implement a new strategic plan aimed at achieving expected cost savings, including a reduction in force[141]. - The company has not sold any shares under the 2023 ATM Program, which allows for sales of up to $150.0 million in common stock[126]. - The company has entered into license agreements with no material changes to commitments and contingencies as of March 31, 2025[139]. - The company may take advantage of exemptions under the JOBS Act, including reduced disclosure about executive compensation arrangements[149].
Entrada Therapeutics(TRDA) - 2025 Q1 - Quarterly Report