BOSTON, March 06, 2023 (GLOBE NEWSWIRE) — Entrada Therapeutics, Inc. (Nasdaq: TRDA), a biopharmaceutical company aiming to transform the lives of patients by establishing intracellular Endosomal Escape Vehicle therapeutics as a new class of medicines, today reported financial results for the fourth quarter and full year ending December 31, 2022 and highlighted recent business updates.
“We made significant progress executing on our strategic initiatives in 2022, highlighted by the expansion of our pipeline, establishing a global, transformative collaboration with Vertex focused on discovering and developing intracellular EEV-therapeutics for myotonic dystrophy type 1 and strengthening our balance sheet,” said Dipal Doshi, President and Chief Executive Officer of Entrada Therapeutics. “We are working diligently to address FDA’s concerns regarding our IND for ENTR-601-44 and remain very confident in achieving our goal of initiating a healthy volunteer trial in 2023. Fundamentally, we believe we are well-positioned to advance our pipeline in the year ahead to create value for patients and shareholders.”
Recent Corporate Highlights
- In December 2022, the U.S. Food and Drug Administration (FDA) placed the Investigational New Drug (IND) application on hold for ENTR-601-44 for the potential treatment of people living with Duchenne who are amenable to exon 44 skipping, requesting that the Company gather and submit additional information. The Company is actively working to resolve the clinical hold as quickly as possible. Given the extraordinary unmet medical need, Entrada is simultaneously pursuing global opportunities with the continued goal of initiating a healthy volunteer trial in 2023.
- In December 2022, the U.S. FDA Office of Orphan Products Development (OOPD) granted orphan drug designation for ENTR-601-44 for the treatment of Duchenne muscular dystrophy.
- In January 2023, Entrada selected the second clinical candidate within its Duchenne franchise, ENTR-601-45, for the potential treatment of people living with Duchenne who are exon 45 skipping amenable. The Company plans to submit an IND application in the fourth quarter of 2024.
- In February 2023, Entrada announced the closing of its strategic collaboration and license agreement with Vertex for the discovery and development of intracellular EEV-therapeutics for myotonic dystrophy type 1 (DM1). The collaboration includes ENTR-701, which is in late-stage preclinical development. Under the terms of the agreement, Entrada received an upfront payment of $224 million, as well as an equity investment of $26 million in February 2023. Entrada is eligible to receive up to $485 million for the successful achievement of certain research, development, regulatory and commercial milestones, and tiered royalties on future net sales for any products that may result from the collaboration agreement.
The Company will present at the following events during the first quarter of 2023:
- Cowen 43rd Annual Health Care Conference in Boston, MA. Dipal Doshi will join the Neuromuscular and Bone Corporate Panel on March 8, 2023 at 2:10 p.m. EST.
- Muscular Dystrophy Association (MDA) Clinical & Scientific Conference 2023 in Dallas, TX from March 19-22, 2023.
Fourth Quarter and Full Year 2022 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were $188.7 million as of December 31, 2022, compared to $215.6 million as of September 30, 2022 and $291.1 million as of December 31, 2021. The Company anticipates that its existing cash, cash equivalents and marketable securities, together with the proceeds received under the Vertex Agreement, ongoing research support and the anticipated achievement of certain near-term milestones under the Vertex Agreement will be sufficient to extend our cash runway into the second half of 2025, supporting the Company’s expansion and continued development of EEV-therapeutic candidates targeting Duchenne as well as other indications beyond neuromuscular diseases.
Research & Development (R&D) Expenses: R&D expenses were $15.7 million for the fourth quarter of 2022 and $66.6 million for the full year of 2022, compared to $12.4 million and $35.9 million for the same periods in 2021, respectively. This increase was primarily due to additional investment in preclinical studies to support future clinical trials and higher personnel costs (including non-cash stock-based compensation).
General & Administrative (G&A) Expenses: G&A expenses were $9.9 million for the fourth quarter of 2022 and $30.6 million for the full year of 2022, compared to $6.1 million and $15.2 million for the same periods in 2021, respectively. This increase was primarily due to higher personnel costs (including non-cash stock-based compensation), legal costs and other costs associated with Entrada operating as a public company.
Net Loss: Net loss was $24.6 million for the fourth quarter of 2022 and $94.6 million for the full year of 2022, compared to net loss of $18.4 million and $51.2 million for the same periods of 2021, respectively.
About Entrada Therapeutics
Entrada Therapeutics is a biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines, Endosomal Escape Vehicle (EEV™)-therapeutics, to engage intracellular targets that have long been considered inaccessible and undruggable. The Company’s EEV therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through its proprietary, highly versatile and modular EEV platform, Entrada is building a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, immunological, ocular and metabolic diseases, among others. The Company’s lead oligonucleotide programs include ENTR-601-44 and ENTR-601-45 for the potential treatment of people living with Duchenne who are exon 44 and 45 skipping amenable, respectively, as well as our partnered candidate ENTR-701 targeting myotonic dystrophy type 1 (DM1).
For more information about Entrada, please visit our website, www.entradatx.com, and follow us on Twitter and LinkedIn.