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): August 13, 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))

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

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 August 13, 2019, LogicBio Therapeutics, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 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 August 13, 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: August 13, 2019

EX-99.1

Exhibit 99.1

LogicBio Reports Second Quarter 2019 Financial Results and Provides Business Updates

CAMBRIDGE, Mass., August 13, 2019 – LogicBio Therapeutics, Inc. (Nasdaq:LOGC) (LogicBio or the Company), a genome editing company focused on developing medicines to durably treat rare diseases in pediatric patients, today reported financial results and provided a corporate update for the second quarter ended June 30, 2019.

“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 Fred Chereau, CEO of LogicBio. “We look forward to executing towards our upcoming milestones, including our plan to file an Investigational New Drug application for LB-001 in the fourth quarter of 2019.”

Business Highlights Include:

 

   

Rare Pediatric Disease Designation for LB-001 in July 2019. The FDA grants 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 FDA in April 2019.

 

   

Closed $20 Million Secured Debt Facility with Oxford Finance LLC and Horizon Technology Finance Corporation in July 2019. Under the agreement, $10 million was drawn down at closing and $10 million will 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 June 30, 2019 and 2018

 

   

R&D Expenses: Research and development expenses were $7.9 million for the three months ended June 30, 2019, compared to $2.2 million for the same period last year. The increase of approximately $5.7 million was primarily due to an increase of approximately $3.9 million


 

related to external development and manufacturing expenses for our lead product candidate LB-001, $0.8 million in 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 million in personnel-related costs due to an increase in headcount. Personnel-related costs for the three months ended June 30, 2019 included stock-based compensation expense of $0.2 million, compared to $48,000 for the three months ended June 30, 2018.

 

   

G&A Expenses: General and administrative expenses were $2.5 million for the three months ended June 30, 2019, compared to $1.4 million for the same period last year. The increase of approximately $1.1 million was 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 million and $0.1 million for the three months ended June 30, 2019 and 2018, respectively.

 

   

Net Loss: Net loss attributable to common stockholders was $10.0 million, or $0.45 per share, for the three months ended June 30, 2019, compared to a net loss attributable to common stockholders of $8.2 million, or $4.19 per share, for the same period last year.

 

   

Cash Position and Financial Guidance: Cash, cash equivalents and investments were $63.7 million as 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.


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 June 30,     Six Months Ended June 30,  
     2019     2018     2019     2018  

OPERATING EXPENSES:

        

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

   $ (10,048   $ (3,587   $ (17,745   $ (5,891
  

 

 

   

 

 

   

 

 

   

 

 

 

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

(In thousands)

(Unaudited)

 

     As of  
     June 30, 2019      December 31, 2018  

Cash, cash equivalents and investments

   $ 63,656      $ 80,906  

Other assets

     4,374        2,004  
  

 

 

    

 

 

 

TOTAL ASSETS

   $ 68,030      $ 82,910  
  

 

 

    

 

 

 

Accounts payable, accrued expenses and other liabilities

   $ 4,619      $ 2,685  

Stockholders’ equity

     63,411        80,225  
  

 

 

    

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

   $ 68,030      $ 82,910  
  

 

 

    

 

 

 

Contacts:

Brian Luque

Associate Director, Investor Relations

bluque@logicbio.com

951-206-1200

Stephanie Simon

Ten Bridge Communications

stephanie@tenbridgecommunications.com

617-581-9333