8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 14, 2019

 

 

LOGICBIO THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38707   47-1514975

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

99 Erie St.

Cambridge, MA

  02139
(Address of principal executive offices)   (Zip Code)

(Registrant’s telephone number, including area code): (617) 245-0399

Not Applicable

(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.  ☒

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, par value $0.0001 per share   LOGC   Nasdaq Global Market

 

 

 


Item 2.02 Results of Operations and Financial Condition.

On May 14, 2019, LogicBio Therapeutics, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 2019. 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.

(d) Exhibits

 

Exhibit
No.
  

Description

99.1    Press Release issued by LogicBio Therapeutics, Inc. on May 14, 2019.


SIGNATURES

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

  Matthias Jaffé
 

Chief Financial Officer

Date: May 14, 2019

EX-99.1

Exhibit 99.1

LogicBio Reports First Quarter 2019 Financial Results and Provides Business Updates

CAMBRIDGE, Mass., May 14, 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 first quarter ended March 31, 2019.

“During the quarter, we continued to make progress advancing GeneRideTM, our proprietary promoterless, nuclease-free genome editing platform, and built our team with several experienced hires.” said Fred Chereau, CEO of LogicBio. “In April, our lead candidate, LB-001, received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of methylmalonic acidemia (MMA), and we are continuing to work towards an Investigational New Drug (IND) filing for this program in late 2019.”

Recent Highlights and Outlook

Orphan Designation for Lead Product Candidate LB-001: The Company is initially examining the potential of its GeneRide platform in MMA, a life-threatening rare disease characterized by the toxic buildup of metabolites starting in early childhood for which there are no approved therapies. In April 2019, LB-001 was granted orphan drug designation by the FDA. LogicBio expects to file an IND for LB-001 in the fourth quarter of 2019 and initiate a Phase 1/2 trial in 2020.

Continued Expansion of Team: In April, LogicBio announced several new hires to support the continued development of GeneRide. The Company welcomed Matthias Hebben, Ph.D., as vice president, technology development, Marie Payton, MBA, as vice president, clinical operations, Carol Sherako, MBA, PMP, as senior director, program management, Sven Loebrich, Ph.D., as director of process development and Lauren Drouin, Ph.D., as associate director, analytical development. LogicBio also announced its move into new facilities and expanded lab space, which will support the continued growth of its pipeline and team.

Developing Genome Editing Platform GeneRide: GeneRide is LogicBio’s proprietary promoterless, nuclease-free genome editing technology. GeneRide is designed to harness homologous recombination to precisely integrate corrective genes into a patient’s genome and leverage endogenous promoters to drive gene expression, to potentially provide a stable therapeutic effect. LogicBio is initially targeting rare liver disorders in pediatric patients where it is critical to provide treatment early in a patient’s 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 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.


First Quarter 2019 Financial Results

 

   

R&D Expenses: Research and development expenses were $5.5 million for the three months ended March 31, 2019, compared to $1.5 million for the same period last year. The increase was primarily attributable to an increase in overall research and development activities, including manufacturing expenses related to the Company’s lead product candidate, LB-001.

 

   

G&A Expenses: General and administrative expenses were $2.6 million for the three months ended March 31, 2019, compared to $0.9 million for the same period last year. The increase was primarily attributable to an increase in professional fees, including legal, auditing and consulting services as a result of the Company’s transition from a private company to a public company, as well as an increase in personnel-related costs, primarily due to an increase in headcount.

 

   

Net Loss: Net loss attributable to common stockholders was $7.7 million, or $0.34 per share, for the three months ended March 31, 2019, compared to a net loss attributable to common stockholders of $4.9 million, or $2.75 per share, for the same period last year.

 

   

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments were $72.5 million as of March 31, 2019. The Company expects that its cash, cash equivalents and investments will be sufficient to fund its operating expenses through 2020.

About LogicBio Therapeutics

LogicBio Therapeutics is a genome editing company focused on developing medicines to durably treat rare diseases in pediatric 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 potential lifelong expression. Headquartered in Cambridge, Mass., LogicBio is committed to developing medicines that will transform the lives of pediatric patients and their families.

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 U.S. Securities and Exchange Commission (SEC), including, without limitation, the Company’s Annual Report on Form 10-K filed on April 1, 2019 with the SEC, and the Company’s subsequent Quarterly Reports on Form 10-Q and other filings 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.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share data)

(Unaudited)

 

     Three Months Ended March 31,  
     2019     2018  

OPERATING EXPENSES:

    

Research and development

   $ 5,486     $ 1,455  

General and administrative

     2,632       918  
  

 

 

   

 

 

 

Total operating expenses

     8,118       2,373  
  

 

 

   

 

 

 

LOSS FROM OPERATIONS

     (8,118     (2,373
  

 

 

   

 

 

 

OTHER INCOME, NET:

    

Interest income, net

     443       68  

Other income, net

     —         3  
  

 

 

   

 

 

 

Total other income, net

     443       71  
  

 

 

   

 

 

 

Loss before income taxes

     (7,675     (2,302

Income tax provision

     (22     (2
  

 

 

   

 

 

 

Net loss

   $ (7,697   $ (2,304
  

 

 

   

 

 

 

Net loss attributable to common stockholders—basic and diluted

   $ (7,697   $ (4,907
  

 

 

   

 

 

 

Net loss per share attributable to common stockholders—basic and diluted

   $ (0.34   $ (2.75
  

 

 

   

 

 

 

Weighted-average common stock outstanding—basic and diluted

     22,313,129       1,787,342  
  

 

 

   

 

 

 

LogicBio Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(In thousands)

(Unaudited)

 

     As of  
     March 31, 2019      December 31, 2018  

Cash, cash equivalents and investments

   $ 72,536      $ 80,906  

Other assets

     4,105        2,004  
  

 

 

    

 

 

 

TOTAL ASSETS

   $ 76,641      $ 82,910  
  

 

 

    

 

 

 

Accounts payable, accrued expenses and other liabilities

   $ 3,825      $ 2,685  

Stockholders’ equity

     72,816        80,225  
  

 

 

    

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

   $ 76,641      $ 82,910  
  

 

 

    

 

 

 

Contacts:

Michael Schaffzin

Stern Investor Relations

Michael.schaffzin@sternir.com

212-362-1200

Stephanie Simon

Ten Bridge Communications

stephanie@tenbridgecommunications.com

617-581-9333