LogicBio Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Updates
“We are thrilled to have received clearance to move forward with this first-in-human clinical trial with our lead product candidate, LB-001, for the treatment of methylmalonic acidemia, a life-threatening congenital genetic disease with no current therapeutic treatment options. This represents a significant milestone in our goal of bringing a treatment to MMA patients as well as for our GeneRide platform. We have maintained continuous dialogue with the centers of excellence that are planned to participate in the Phase 1/2 clinical trial, and we look forward to activating these sites as quickly as possible,” said
Commenting on the Next Generation Capsid Program,
“Daniel has been instrumental in leading LB-001 clinical development efforts including getting the IND cleared. His deep experience in genetic medicines and metabolic diseases will serve LogicBio well as we look to execute on our goals for both the GeneRide and Next Generation Capsid platforms in search of transformative medicines,” said
Anticipated Milestones for 2020 and 2021:
- GeneRide Platform
- LB-001 for MMA
- Early 2021: First patient enrollment in Phase 1/2 trial
- Early 2021: Translational model data
- LB-001 for MMA
- Next Gen Capsid Platform
- Early 2021: Translational model data
Second Quarter 2020 Financial Results
Three Months Ended
- R&D Expenses: Research and development expenses for the three months ended
June 30, 2020were $5.9 million, compared to $7.9 millionfor three months ended June 30, 2019. The decrease was primarily due to decreases of approximately $2.3 millionin external development and manufacturing expenses for the Company’s lead product candidate, LB-001, and a decrease of $0.1 millionin personnel-related costs as increased headcount was offset by salary cuts related to the COVID-19 pandemic. These decreases were partially offset by an increase of $0.3 millionin other research and development expenses as the Company increased its overall research and development activities related to general platform development. While there may be fluctuations on a quarterly basis, the Company expects that its research and development costs will decrease during 2020 as compared to 2019 as it has already incurred a significant proportion of the LB-001 external development and manufacturing costs needed to bring LB-001 into clinical development.
- G&A Expenses: General and administrative expenses were
$3.0 millionfor the three months ended June 30, 2020, compared to $2.5 millionfor the three months ended June 30, 2019. The increase was primarily due to increases in corporate legal expense, D&O insurance premiums and non-capitalizable facilities expenses. The Company expects that general and administrative expenses will remain relatively consistent during 2020 as compared to 2019 although there may be fluctuations on a quarterly basis.
- Net Loss: Net loss was
$8.2 million, or $0.35per share, for the three months ended June 30, 2020, compared to a net loss of $10.0 million, or $0.45per share, for the three months ended June 30, 2019.
- Cash Position and Financial Guidance: Cash and cash equivalents were
$36.7 millionas of June 30, 2020. The Company believes that its cash and cash equivalents as of June 30, 2020will enable the Company to fund operating expenses and capital expenditure requirements into the third quarter of 2021.
LogicBio Therapeutics is dedicated to extending the reach of genetic medicine with pioneering targeted delivery platforms.
LogicBio’s proprietary genome editing technology platform, GeneRide, enables the site-specific integration of a therapeutic transgene without nucleases or exogenous promoters by harnessing the native process of homologous recombination. LogicBio has received FDA clearance for the first-in-human clinical trial of LB-001, a wholly owned genome editing program leveraging GeneRide for the treatment of methylmalonic acidemia. Patient enrollment is expected to begin in early 2021. In addition, LogicBio has a collaboration with
LogicBio is also developing a Next Generation Capsid platform for use in gene editing and gene therapies. Data presented have shown that the capsids deliver highly efficient functional transduction of human hepatocytes with improved manufacturability with low levels of pre-existing neutralizing antibodies in human samples. Top-tier capsid candidates from this effort demonstrated significant improvements over benchmark AAVs currently in clinical development. LogicBio is developing these highly potent vectors for internal development candidates and potentially for business development collaborations.
LogicBio is headquartered in Lexington, Mass. 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 initiate, advance and complete its planned SUNRISE Phase 1/2 clinical trial of LB-001 in MMA; the timing, progress and results of the Company’s research and development activities, including those related to the GeneRide technology platform and Next Generation Capsid Program; its plans for LB-301 in Crigler-Najjar; and the sufficiency of its cash and cash equivalents to fund operating expenses and capital expenditure requirements. 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. In particular, the impact of the COVID-19 pandemic on the Company’s ability to progress with its research, development, manufacturing and regulatory efforts, including the Company’s plans to initiate, advance and complete its Phase 1/2 clinical trial for LB-001 in MMA, and the value of and market for the Company’s common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share data)|
|Three Months Ended
||Six Months Ended
|Research and development||5,895||7,934||13,068||$||13,420|
|General and administrative||3,029||2,524||6,221||5,156|
|Total operating expenses||8,924||10,458||19,289||18,576|
|LOSS FROM OPERATIONS||(7,959||)||(10,458||)||(17,303||)||(18,576||)|
|OTHER INCOME (EXPENSE), NET:|
|Other expense, net||(5||)||(1||)||(11||)||(1||)|
|Total other (expense) income, net||(268||)||410||(379||)||853|
|Loss before income taxes||(8,227||)||(10,048||)||(17,682||)||(17,723||)|
|Income tax provision||—||—||—||(22||)|
|Net loss per share—basic and diluted||$||(0.35||)||$||(0.45||)||$||(0.76||)||$||(0.79||)|
|Weighted-average common stock outstanding—basic and diluted||23,326,018||22,479,511||23,250,910||22,396,780|
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and investments||$||36,697||$||50,647|
|Accounts payable, accrued expenses and other liabilities||$||19,187||$||13,373|
|TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY||$||47,343||$||55,660|
Associate Director, Investor Relations
Source: LogicBio Therapeutics