LogicBio Reports Second Quarter 2019 Financial Results and Provides Business Updates
“Over this quarter, we continued to make steady progress advancing GeneRideTM, our proprietary promoterless, nuclease-free genome editing platform with the potential to durably treat rare diseases in pediatric patients. We are committed to building a broad pipeline of product candidates to capture the full value of GeneRide, beginning with our lead product candidate, LB-001 for the treatment of methylmalonic acidemia (MMA), a rare and life-threatening pediatric disease,” said
Business Highlights Include:
- Rare Pediatric Disease Designation for LB-001 in
July 2019. The FDAgrants rare pediatric disease designation for serious and life-threatening diseases that primarily affect children through age 18 and affect fewer than 200,000 people in the United States. Separately, LB-001 was also granted orphan drug designation by the FDAin April 2019.
$20 MillionSecured Debt Facility with Oxford Finance LLCand Horizon Technology Finance Corporationin July 2019. Under the agreement, $10 millionwas drawn down at closing and $10 millionwill be available following the enrollment of the first patient in the Company’s Phase 1/2 clinical trial of LB-001.
Anticipated Milestones for 2019 and 2020:
- LB-001 for MMA
-- 4Q 2019: Filing of Investigational New Drug (IND) application
-- Details regarding clinical trial size, endpoints and timelines to be communicated upon IND acceptance.
-- 4Q 2019: Initiation of natural history study
-- 1H 2020: Initiation of Phase 1/2 trial
-- 2H 2020: Preliminary data from Phase 1/2 trial
- GeneRide Platform
-- Q4 2019: Nominate a second therapeutic indication to be pursued using the GeneRide platform
Second Quarter 2019 Financial Results
Three Months Ended
- R&D Expenses: Research and development expenses were
$7.9 millionfor the three months ended June 30, 2019, compared to $2.2 millionfor the same period last year. The increase of approximately $5.7 millionwas primarily due to an increase of approximately $3.9 millionrelated to external development and manufacturing expenses for our lead product candidate LB-001, $0.8 millionin other research and development expenses as we increased our overall research and development activities related to general platform development and internal efforts for LB-001 and $1.0 millionin personnel-related costs due to an increase in headcount. Personnel-related costs for the three months ended June 30, 2019included stock-based compensation expense of $0.2 million, compared to $48,000for the three months ended June 30, 2018.
- G&A Expenses: General and administrative expenses were
$2.5 millionfor the three months ended June 30, 2019, compared to $1.4 millionfor the same period last year. The increase of approximately $1.1 millionwas primarily due to professional fees and personnel-related costs, including salaries, stock-based compensation and bonuses. The increase in professional fees was primarily due to an increase in legal, auditing and consulting services provided. The increase in personnel-related costs was primarily due to an increase in headcount of senior level employees. Stock-based compensation expense included in general and administrative expenses was $0.3 millionand $0.1 millionfor the three months ended June 30, 2019and 2018, respectively.
- Net Loss: Net loss attributable to common stockholders was
$10.0 million, or $0.45per share, for the three months ended June 30, 2019, compared to a net loss attributable to common stockholders of $8.2 million, or $4.19per share, for the same period last year.
- Cash Position and Financial Guidance: Cash, cash equivalents and investments were
$63.7 millionas of June 30, 2019. The Company expects that its cash, cash equivalents and investments at June 30, 2019, together with the net proceeds received under the Secured Debt Facility entered into on July 2, 2019, are projected to fund the Company’s planned operations into 2021.
For more information, please visit www.logicbio.com.
Forward Looking Statements
This press release contains “forward-looking” statements within the meaning of the federal securities laws. These are not statements of historical facts and are based on management’s beliefs and assumptions and on information currently available. They are subject to risks and uncertainties that could cause the actual results and the implementation of the Company’s plans to vary materially, including the risks associated with the initiation, cost, timing, progress and results of the Company’s current and future research and development activities and preclinical studies and potential future clinical trials. These risks are discussed in the Company’s filings with the
|LogicBio Therapeutics, Inc.|
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share data)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||$||7,934||$||2,226||$||13,420||$||3,681|
|General and administrative||2,524||1,416||5,156||2,334|
|Total operating expenses||10,458||3,642||18,576||6,015|
|LOSS FROM OPERATIONS||(10,458||)||(3,642||)||(18,576||)||(6,015||)|
|OTHER INCOME, NET:|
|Interest income, net||411||60||854||128|
|Other expense, net||(1||)||(7||)||(1||)||(4||)|
|Total other income, net||410||53||853||124|
|Loss before income taxes||(10,048||)||(3,589||)||(17,723||)||(5,891||)|
|Income tax benefit (provision)||-||2||(22||)||-|
|Net loss attributable to common stockholders—basic and diluted||$||(10,048||)||$||(8,217||)||$||(17,745||)||$||(10,521||)|
|Net loss per share attributable to common stockholders—basic and diluted||$||(0.45||)||$||(4.19||)||$||(0.79||)||$||(5.61||)|
|Weighted-average common stock outstanding—basic and diluted||22,479,511||1,962,570||22,396,780||1,875,440|
|LogicBio Therapeutics, Inc.|
|Condensed Consolidated Balance Sheets|
|June 30, 2019||December 31, 2018|
|Cash, cash equivalents and investments||$||63,656||$||80,906|
|Accounts payable, accrued expenses and other liabilities||$||4,619||$||2,685|
|TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY||$||68,030||$||82,910|
Associate Director, Investor Relations
Ten Bridge Communications
Source: LogicBio Therapeutics