SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 1, 2019
LOGICBIO THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction
|99 Erie St.|
|(Address of principal executive offices)||(Zip Code)|
(Registrants telephone number, including area code): (617) 245-0399
610 Main Street, 3rd Floor
Cambridge, MA 02139
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 2.02 Results of Operations and Financial Condition.
On April 1, 2019, LogicBio Therapeutics, Inc. issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2018. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
|99.1||Press Release issued by LogicBio Therapeutics, Inc. on April 1, 2019.|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|LOGICBIO THERAPEUTICS, INC.|
|By:||/s/ Matthias Jaffé|
|Chief Financial Officer|
Date: April 1, 2019
LogicBio Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Business Updates
CAMBRIDGE, Mass., April 1, 2019 LogicBio Therapeutics, Inc. (Nasdaq:LOGC) (LogicBio or the Company), a genome editing company focused on developing medicines to durably treat rare diseases, today reported financial results and provided a corporate update for the fourth quarter and full year ended December 31, 2018.
In 2018 we made steady progress advancing GeneRide, our proprietary promoterless, nuclease-free genome editing platform, said Fred Chereau, CEO of LogicBio. This year, we intend to file an Investigational New Drug (IND) application for our lead candidate, LB-001, in methylmalonic acidemia. We will also continue to build out our team to expand our CMC capacity and analytical development capabilities as we advance our pipeline of product candidates designed to deliver disease-modifying therapies to pediatric patients with rare diseases. Finally, we are excited about our ongoing work developing next-generation adeno-associated virus (AAV) vectors in partnership with the Childrens Medical Research Institute in Australia, a world leader in gene therapy.
Recent Highlights and Outlook
Significant Expansion of Leadership and Lab Space to Support Advancement of Pipeline: LogicBio significantly expanded its research and technology development groups as well as its leadership team as the Company continues to advance its lead product candidate to an expected IND filing by the end of 2019. Of note, in February 2019, the Company appointed Kenneth Huttner, M.D., Ph.D., as Senior Vice President, Head of Clinical Development, and in December 2018, announced the appointment of Richard Moscicki, M.D., and Michael Wyzga to its Board of Directors. LogicBio has also tripled the size of its lab space and moved into new facilities in Cambridge. The new offices and lab support continued growth of the research team and the development of state-of-the-art analytics to characterize and advance product candidates using GeneRide.
Developing Genome Editing Platform GeneRide: The Company continues to develop GeneRide, its proprietary promoterless, nuclease-free genome editing technology. GeneRide harnesses homologous recombination to precisely integrate corrective genes into a patients genome and leverages endogenous promoters to drive gene expression, providing a stable therapeutic effect. LogicBio is initially targeting rare liver disorders in pediatric patients where it is critical to provide treatment early in a patients life before irreversible disease pathology can occur. The Company continues to use a modular approach to build its pipeline, leveraging the same homology arms, site of integration and delivery vector for each candidate for a given tissue type. Together with its collaborators, LogicBio has demonstrated proof-of-concept for compounds utilizing GeneRide in animal models of methylmalonic acidemia (MMA), hemophilia B, alpha-1-antitrypsin deficiency (A1ATD), and Crigler-Najjar syndrome. The Company is initially pursuing MMA and plans to nominate a second indication by the end of 2019.
Lead Product Candidate LB-001 in Development for MMA: The Company is initially examining the potential of its GeneRide platform in MMA, a life-threatening disease that typically presents at birth for which there are no approved therapies. LogicBio has demonstrated preclinical proof-of-concept of GeneRide in multiple animal models of the disease, improving survival and reversing disease pathology.
In preclinical MMA models, LogicBio has shown that cells into which GeneRide has inserted a transgene demonstrate a selective survival advantage over cells not expressing the transgene. The Company expects to file an IND for LB-001 in the fourth quarter of 2019 and initiate a Phase 1/2 trial in 2020.
Fourth Quarter and Full Year 2018 Financial Results
Cash, cash equivalents, and marketable securities at December 31, 2018, were $80.9 million, compared to $12.9 million at September 30, 2018, and $24.6 million at December 31, 2017.
For the three months ended December 31, 2018, net loss attributable to common stockholders was $7.1 million, or $0.41 per share, compared to $5.0 million, or $3.05 per share, for the same period in 2017. The increase in the fourth quarter and the full year in 2018 was primarily attributable to the proceeds from LogicBios initial public offering (IPO), which was completed in October 2018. The Company received approximately $72,300 in net proceeds after deducting under writing discounts and commissions and offering costs.
R&D Expenses: R&D expenses were $5.0 million for the three months ended December 31, 2018, compared to $2.1 million for the same period last year. The increase was primarily attributable to the increase in the overall research and development activities, including manufacturing expenses related to the lead product candidate, LB-001.
G&A Expenses: General and administrative expenses were $2.4 million for the three months ended December 31, 2018, compared to $1.0 million for the same period last year. The increase was primarily related to operating costs as a result of the Companys transition from a private company to a public company, including legal, accounting and insurance expenses.
For the full year 2018, net loss attributable to common stockholders was $17.6 million, or $3.04 per share, compared to $5.8 million, or $5.54 per share, for 2017.
R&D Expenses: R&D expenses were $11.1 million for 2018, compared to $3.6 million for 2017. The increase was primarily attributable to the increase in the overall research and development activities, including manufacturing expenses related to the lead product candidate, LB-001.
G&A Expenses: General and administrative expenses were $6.9 million for 2018, compared to $2.3 million for 2017. The increase was primarily related to increased operating costs as a result of the Companys transition from a private company to a public company, including legal, accounting and insurance expenses.
About LogicBio Therapeutics
LogicBio Therapeutics is a genome editing company focused on developing medicines to durably treat rare diseases in patients with significant unmet medical needs using GeneRide, its proprietary technology platform. GeneRide enables the site-specific integration of a therapeutic transgene in a nuclease-free and promoterless approach by relying on the native process of homologous recombination to drive lifelong expression. Headquartered in Cambridge, Mass., LogicBio is committed to developing medicines that will transform the lives of pediatric patients and their families.
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 managements 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 Companys plans to vary materially, including the risks associated with the initiation, cost, timing, progress and results of the Companys current and future research and development activities and preclinical studies and potential future clinical trials. These risks are discussed in the Companys filings with the U.S. Securities and Exchange Commission (SEC), including, without limitation, the Companys Quarterly Report on Form 10-Q filed on December 3, 2018 with the SEC. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.
LogicBio Therapeutics, Inc.
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LogicBio Therapeutics, Inc.
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