LogicBio® Therapeutics, Inc. (Nasdaq: LOGC), a clinical-stage genetic medicine company, today reported financial results for the year ended December 31, 2021, and provided business updates.
“At LogicBio, we are continuing to advance our mission to safely deliver novel genetic medicines to people impacted by devastating, early onset diseases,” said Frederic Chereau, president and chief executive officer of LogicBio. “We are pleased to report that the serious adverse event experienced by the fourth patient enrolled in our Phase 1/2 SUNRISE trial of LB-001 in pediatric patients with methylmalonic acidemia has resolved.”
Recent Business Updates:
- In January 2022, the fourth patient dosed in the Phase 1/2 SUNRISE trial experienced a drug-related serious adverse event (SAE), which was categorized as a case of thrombotic microangiopathy. The company announced today that the SAE has resolved. As previously disclosed, after reporting the SAE to the U.S. Food and Drug Administration (FDA), the Investigational New Drug Application for LB-001 was placed on clinical hold. The company is working closely with the FDA and the Data Safety Monitoring Board for SUNRISE to determine the next steps for SUNRISE and the LB-001 program.
- In December 2021, LogicBio announced the nomination of a new development candidate, LB-401, based on the company’s GeneRideTM genome editing platform, for the treatment of hereditary tyrosinemia type 1 (HT1). Preclinical studies of HT1 models with acute liver damage demonstrated that GeneRide-edited hepatocytes repopulated the entire liver within four weeks post-administration, replacing diseased hepatocytes with corrected hepatocytes.
- In December 2021, LogicBio announced the appointment of Susan R. Kahn to its Board of Directors. Ms. Kahn was previously the executive director of the National Tay-Sachs & Allied Diseases Association (NTSAD), a highly regarded patient advocacy group for children and adults affected by rare genetic diseases.
- In October 2021, LogicBio announced clinical trial results from the company’s Phase 1/2 SUNRISE clinical trial of its product candidate, LB-001, in pediatric patients with methylmalonic acidemia demonstrating the first-ever in vivo genome editing in children. Early data showed measurable levels of albumin-2A, a technology-related biomarker indicating site-specific gene insertion and protein expression.
- In October 2021, the company presented new preclinical data highlighting its GeneRide genome editing technology at the European Society of Gene and Cell Therapy Virtual Congress 2021. The data highlighted selective advantage, a key feature of the GeneRide technology, in HT1 and Wilson disease.
Full Year 2021 Financial Results:
- Revenue: Revenue for the year ended December 31, 2021 was $5.4 million, compared to $3.5 million for the year ended December 31, 2020. The increase of approximately $1.9 million was related to collaboration and service revenue recognized under our April 2021 agreements with CANbridge Care Pharma Hong Kong Limited and Daiichi Sankyo Company, Limited, and partially offset by winding down activities under our January 2020 agreement with Takeda Pharmaceutical Company Limited.
- R&D Expenses: Research and development expenses for the year ended December 31, 2021 were $28.2 million, compared to $22.8 million for the year ended December 31, 2020. The increase of approximately $5.4 million was primarily due to increases of $3.8 million in personnel-related costs related to an increase in headcount associated with the progress of both our partnered and internal programs and a corresponding increase of $0.8 million in lab supplies.
- G&A Expenses: General and administrative expenses were $16.2 million for the year ended December 31, 2021, compared to $12.2 million for the year ended December 31, 2020. The increase of approximately $4.0 million was primarily driven by an increase of $2.1 million in personnel expenses, as we increased our headcount to support our continued research and development activities and build our corporate and administrative functions, as well as an increase of $1.3 million in fees associated with professional services due to an increase in corporate development and general corporate activities.
- Net Loss: Net loss for the year ended December 31, 2021 was $40.0 million or $1.24 per share, compared to a net loss of $32.6 million, or $1.29 per share, for the year ended December 31, 2020.
- Cash Position: As of December 31, 2021, we had cash and cash equivalents of $53.5 million as compared to $59.6 million as of September 30, 2021. As of December 31, 2021, we had 32,952,306 shares outstanding.
- Financial Guidance: Based upon our current operating plan, we believe that our $53.5 million in cash and cash equivalents as of December 31, 2021 will enable us to fund our operating expenses and capital expenditure requirements through the first quarter of 2023.
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