LogicBio Reports Full Year 2019 Financial Results and Provides Business Updates
“2019 was a productive year for LogicBio marked by multi-faceted progress, including our new collaboration with
Business Highlights Include:
- Established collaboration with
Takedato leverage the GeneRide platform in a second indication, Crigler-Najjar Syndrome. LogicBio and Takedaagreed to further research and develop LB-301, an investigational pediatric genome editing therapy based on LogicBio’s GeneRide technology for the treatment of CN. The LB-301 construct, utilizing the modularity of GeneRide, is expected to share several components with LB-001 to facilitate development. Those components include: LK-03 as the capsid; the albumin gene as the target genetic locus for integration; and a 2A peptide sequence to facilitate polycistronic expression and serve as a circulating biomarker.
- Extended Sponsored Research Agreement with
Oregon Health & Science Universityto Explore Translation of Pharmaceutically-Driven Selective Advantage of Future GeneRide™ Candidates. The initial phase of the research program provided proof-of-principle of enhanced selective advantage for cells edited by GeneRide in pilot murine experiments. This extension phase focuses on translating the enhancement strategy beyond murine models with the goal of enhancing the clinical translation of future GeneRide candidates and other approaches to genetic medicines.
- Initiated Retrospective Natural History Study in MMA. This study is designed to evaluate disease progression in pediatric patients (born since 2010) with severe MMA, with the aim of informing LogicBio’s future development in MMA and its discussions with regulatory agencies.
- Reported positive data on
Next Generation Capsid Developmentprogram at European Society of Gene and Cell TherapyAnnual Meeting. Data were presented from a set of novel, synthetic adeno-associated virus (AAV) capsid candidates tested against references AAV2, AAV8, and LK-03. All capsids showed selective tropism and more potent transduction and gene expression than the reference capsids in human hepatocytes of a chimeric FRG mouse model. LogicBio, working in partnership with the Children’s Medical Research Institute, intends to advance this research and present additional findings at a scientific conference in 2020.
Full Year 2019 Financial Results
Twelve Months Ended
- R&D Expenses: Research and development expenses for the year ended
December 31, 2019were $30.7 million, compared to $11.1 millionfor year ended December 31, 2018. The increase was primarily due to an increase of approximately $14.1 millionrelated to external development and manufacturing expenses for our lead product candidate LB-001. Personnel-related costs for the year ended December 31, 2019included stock-based compensation expense of $0.8 millioncompared to $0.3 millionfor the year ended December 31, 2018.
- G&A Expenses: General and administrative expenses were
$10.4 millionfor the year ended December 31, 2019, compared to $6.9 millionfor the year ended December 31, 2018. The increase was primarily due to increases in legal and professional fees and personnel-related costs primarily due to an increase in headcount. Stock-based compensation expense included in general and administrative expenses was $1.0 millionand $0.8 millionfor the years ended December 31, 2019and 2018, respectively.
- Net Loss: Net loss was
$40.1 million, or $1.78per share, for the year ended December 31, 2019, compared to a net loss of $17.6 million, or $3.04per share, for the year ended December 31, 2018.
- Cash Position and Financial Guidance: Cash, cash equivalents and investments were
$50.6 millionas of December 31, 2019. Based upon our current operating plan, which takes into account expenditures that are contingent based on corporate developments, we believe that our cash and cash equivalents and short-term investments as of December 31, 2019will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2021.
For more information, please visit www.logicbio.com.
Forward Looking Statements
This press release contains “forward-looking” statements within the meaning of the federal securities laws, including those related to the Company’s plans to resolve the FDA’s clinical hold on the IND for LB-001; the timing, progress and results of the Company’s research and development activities, including those related to the GeneRide technology platform; and the anticipated construct for LB-301 in Crigler-Najjar. These are not statements of historical facts and are based on management’s beliefs and assumptions and on information currently available. They are subject to risks and uncertainties that could cause the actual results and the implementation of the Company’s plans to vary materially, including the risks associated with the initiation, cost, timing, progress and results of the Company’s current and future research and development activities and preclinical studies and potential future clinical trials. These risks are discussed in the Company’s filings with the
|Consolidated Statements of Operations|
|(In thousands, except share and per share data)|
|Research and development||$||30,656||$||11,079|
|General and administrative||10,385||6,864|
|Total operating expenses||41,041||17,943|
|LOSS FROM OPERATIONS||(41,041||)||(17,943||)|
|OTHER INCOME (EXPENSE), NET:|
|Other expense, net||(19||)||(159||)|
|Total other income, net||935||408|
|Loss before income taxes||(40,106||)||(17,535||)|
|Income tax provision||(22||)||(86||)|
|Net loss per share—basic and diluted||$||(1.78||)||$||(3.04||)|
|Weighted-average common stock outstanding—basic and diluted||22,602,954||5,801,533|
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and investments||$||50,647||$||80,906|
|Accounts payable, accrued expenses and other liabilities||$||13,373||$||2,685|
|TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY||$||55,660||$||82,910|
Associate Director, Investor Relations
Source: LogicBio Therapeutics