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 11, 2020

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.)

 

65 Hayden Avenue, 2nd Floor    
Lexington, MA   02421
(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 May 11, 2020, LogicBio Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three month period ended March 31, 2020. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in Item 2.02 of 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 (the “Securities Act”), 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 11, 2020.


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/ Bryan Yoon
 

Bryan Yoon

Chief Administrative Officer and General Counsel

Date: May 11, 2020

EX-99.1

Exhibit 99.1

LogicBio Reports First Quarter 2020 Financial Results and Provides Business Updates

LEXINGTON, Mass., May 11, 2020 – 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 for the quarter ended March 31, 2020 and provided a business update.

“We remain committed to advancing LB-001 to the clinic for methylmalonic acidemia (MMA) as quickly as possible. We have had preliminary interactions with the FDA regarding their questions on our IND for LB-001 and plan to continue these interactions through the middle of the year. We look forward to providing an update on the anticipated timing for the initiation of our Phase 1/2 clinical trial for LB-001 after we complete these interactions,” said Fred Chereau, CEO of LogicBio. “At the same time, we continue to advance our research programs and look forward to sharing the fruits of our ongoing work in rare diseases including MMA and Crigler-Najjar (CN) syndrome at this year’s virtual ASGCT annual meeting.”

Updates to Business Operations in Response to COVID-19

LogicBio has been actively monitoring the COVID-19 pandemic and its impact globally. LogicBio’s objectives have remained the same throughout the pandemic: to support the safety of its team members and their families and continue its research and development activities to develop genetic medicines that have the potential to durably treat rare diseases in pediatric patients with significant unmet medical need.

Since mid-March, the Company’s non-laboratory employees have been working remotely to comply with social distancing and “stay at home” orders as well as applicable guidelines from the U.S. Centers for Disease Control and Prevention. LogicBio’s laboratory employees, whose work must be performed on premises, have been working in shifts to continue in-house research and manufacturing activities on a decreased basis. LogicBio has also ceased all business travel for its employees and plans to maintain these or similar restrictions on its business activities until LogicBio believes that its employees can fully resume such activities in accordance with federal, state and local requirements and guidelines.

Business Highlights Include:

 

   

Initiated work supporting collaboration with Takeda to leverage the GeneRide platform in Crigler-Najjar Syndrome. LogicBio and Takeda agreed to further research and develop LB-301, an investigational pediatric genome editing therapy based on LogicBio’s GeneRide technology for the treatment of CN. LB-301, utilizing the modularity of GeneRide, is expected to share several components with LB-001 to facilitate development.

 

   

Moved headquarters to support platform development and capabilities expansion. The new lab and office space doubles the Company’s available space compared to its previous headquarters.


   

Appointment of Mark Enyedy to Board of Directors. Mr. Enyedy brings over 25 years of deep experience in biotech management, strategy, and corporate development, and currently serves as President and Chief Executive Officer of Immunogen, Inc.

First Quarter 2020 Financial Results

Three Months Ended March 31, 2020 and 2019

 

   

R&D Expenses: Research and development expenses for the three months ended March 31, 2020 were $7.2 million, compared to $5.5 million for three months ended March 31, 2019. The increase was primarily due to an increase of approximately $0.7 million related to external development and manufacturing expenses for the Company’s lead product candidate, LB-001, $0.4 million in other research and development expenses related to general platform development and $0.6 million in personnel-related costs due to an increase in headcount. While there may be fluctuations on a quarterly basis, the Company expects that its research and development costs will decrease over the next twelve months as it believes that 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 $3.2 million for the three months ended March 31, 2020, compared to $2.6 million for the three months ended March 31, 2019. The increase was primarily due to an increase in personnel-related costs due to an increase in headcount. The Company expects that general and administrative expenses will remain relatively consistent over the next twelve months, although there may be fluctuations on a quarterly basis.

 

   

Net Loss: Net loss was $9.5 million, or $0.41 per share, for the three months ended March 31, 2020, compared to a net loss of $7.7 million, or $0.34 per share, for the three months ended March 31, 2019.

 

   

Cash Position and Financial Guidance: Cash and cash equivalents were $43.2 million as of March 31, 2020. The Company believes that its cash and cash equivalents as of March 31, 2020 will enable the Company to fund operating expenses and capital expenditure requirements through the second quarter of 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 Lexington, 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, including those related to the Company’s plans to resolve the FDA’s clinical hold on the IND for LB-001; the timing, progress and results of the Company’s research and development activities, including those related to the GeneRide technology platform; its plans for LB-301 in Crigler-Najjar; and the sufficiency of its cash, cash equivalents and investments 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, while the Company expects the COVID-19 pandemic to adversely affect its business operations and financial results, the extent of the impact on the Company’s ability to progress with its research, development, manufacturing and regulatory efforts, including the Company’s plans to resolve the clinical hold placed by the FDA on the IND for LB-001, 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 the United States and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. 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 March 16, 2020 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,  
     2020     2019  

REVENUE

    

Service revenue

   $ 1,021     $  
  

 

 

   

 

 

 

Total revenue

     1,021        

OPERATING EXPENSES

    

Research and development

     7,173       5,486  

General and administrative

     3,192       2,632  
  

 

 

   

 

 

 

Total operating expenses

     10,365       8,118  
  

 

 

   

 

 

 

LOSS FROM OPERATIONS

     (9,344     (8,118
  

 

 

   

 

 

 

OTHER INCOME (EXPENSE), NET

    

Interest income

     167       443  

Interest expense

     (272      

Other expense, net

     (6      
  

 

 

   

 

 

 

Total other income (expense), net

     (111     443  
  

 

 

   

 

 

 

Loss before income taxes

     (9,455     (7,675

Income tax provision

           (22
  

 

 

   

 

 

 

Net loss

   $ (9,455   $ (7,697
  

 

 

   

 

 

 

Net loss per share—basic and diluted

   $ (0.41   $ (0.34
  

 

 

   

 

 

 

Weighted-average common stock outstanding—basic and diluted

     23,175,802       22,313,129  
  

 

 

   

 

 

 

LogicBio Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(In thousands)

(Unaudited)

 

     As of  
     March 31,
2020
     December 31,
2019
 

Cash, cash equivalents and investments

   $ 43,153      $ 50,647  

Other assets

     5,596        5,013  
  

 

 

    

 

 

 

TOTAL ASSETS

   $ 48,749      $ 55,660  
  

 

 

    

 

 

 

Accounts payable, accrued expenses and other liabilities

   $ 15,042      $ 13,373  

Stockholders’ equity

     33,707        42,287  
  

 

 

    

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

   $ 48,749      $ 55,660  
  

 

 

    

 

 

 

Contacts:

Brian Luque

Associate Director, Investor Relations

bluque@logicbio.com

951-206-1200