Financial Position - The company has an accumulated deficit of $185.4 million as of September 30, 2023, and expects to continue generating operating losses and negative cash flows for the foreseeable future[134]. - As of September 30, 2023, the company had cash, cash equivalents, and marketable securities totaling $353.6 million, which is expected to extend its cash runway through 2025[138]. - The company has raised over $650 million in gross proceeds since inception, primarily from stock sales and the Vertex Agreement[133]. - The company expects to extend its cash runway through 2025, supported by cash, cash equivalents, and marketable securities as of September 30, 2023[178]. - The company may finance its cash needs through equity offerings, debt financings, and collaborations, which could dilute existing stockholder ownership[179]. Revenue and Income - Collaboration revenue for the three months ended September 30, 2023, was $43.7 million, all related to the Vertex Agreement, compared to no revenue in the same period of 2022[155]. - For the nine months ended September 30, 2023, collaboration revenue was $87.2 million, all related to the Vertex Agreement, compared to no revenue in the same period of 2022[163]. - Total interest and other income for the nine months ended September 30, 2023, was $10.9 million, compared to $1.7 million in the same period of 2022, driven by higher interest rates and larger investments[166]. - Net income for the three months ended September 30, 2023, was $35.5 million, a significant improvement from a net loss of $25.1 million in the same period of 2022, representing a change of $60.6 million[154]. Operating Expenses - Total operating expenses for the three months ended September 30, 2023, were $29.7 million, an increase of $3.8 million from $25.9 million in the same period of 2022[154]. - Research and development expenses for the three months ended September 30, 2023, were $22.2 million, up from $19.0 million in the same period of 2022, reflecting an increase of $3.2 million[157]. - General and administrative expenses for the three months ended September 30, 2023, were $7.5 million, compared to $7.0 million in the same period of 2022, an increase of $0.5 million[160]. - The company anticipates that research and development expenses will continue to increase as it progresses its clinical trials and develops new therapeutic candidates[159]. - The company reported a $1.5 million increase in personnel costs, primarily due to headcount growth in general and administrative functions[170]. - Operating expenses and future funding requirements are anticipated to increase substantially as the company advances its portfolio of programs[178]. Clinical Development - The company plans to submit a Clinical Trial Application (CTA)/IND application for ENTR-601-45 in the fourth quarter of 2024[127]. - The first participant has been dosed in the Phase 1 clinical trial evaluating ENTR-601-44, with data expected to be reported in the second half of 2024[126]. - The company has entered into a license agreement with Pierrepont Therapeutics to advance the development of ENTR-501 for mitochondrial neurogastrointestinal encephalomyopathy (MNGIE)[130]. - The company is developing ENTR-601-50 for Duchenne muscular dystrophy, with preclinical data expected to be reported in the first half of 2024[128]. - A milestone payment of $17.5 million related to preclinical IND-enabling studies of ENTR-701 is expected to be received in the fourth quarter of 2023[132]. Financing Activities - The company entered into a sales agreement with Cowen to issue and sell shares of common stock for up to $150.0 million under the 2023 ATM Program, with no shares sold as of September 30, 2023[169]. - Net cash provided by financing activities was $20.3 million, consisting of $19.4 million from the issuance of 1,618,613 shares related to the Vertex Agreement[176]. - The company has not sold any shares under the ATM program as of the end of September 2023, indicating a potential for future capital raising[169]. Regulatory and Compliance - The company anticipates incurring additional costs associated with operating as a public company, including legal and accounting expenses[135]. - The company is an "emerging growth company" and a "smaller reporting company," allowing it to take advantage of reduced reporting requirements under the JOBS Act[183][185].
Entrada Therapeutics(TRDA) - 2023 Q3 - Quarterly Report