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): November 12, 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 November 12, 2019, LogicBio Therapeutics, Inc. issued a press release announcing its financial results for the third quarter ended September 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 November 12, 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: November 12, 2019

EX-99.1

Exhibit 99.1

LogicBio Reports Third Quarter 2019 Financial Results and Provides Business Updates

CAMBRIDGE, Mass., November 12, 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 third quarter ended September 30, 2019.

“This has been a focused and highly productive stretch for the entire LogicBio team. Among other accomplishments, we have completed manufacture of GMP grade clinical material for LB-001, our investigational therapy for the treatment of methylmalonic acidemia, and we are taking the final steps needed to submit our first Investigational New Drug application. We look forward to confirming our submission by the end of the year,” said Fred Chereau, CEO of LogicBio. “We also continue to execute other elements of our business plan, including advancing the next generation capsid initiative and building out the team and facilities we need to leverage our modular GeneRideTM platform across multiple indications.”

Business Highlights Include:

 

   

Reported positive data on Next Generation Capsid Development and GeneRide platform programs at European Society of Gene and Cell Therapy 27th Annual Congress. Data were presented from a set of novel, synthetic adeno-associated virus (AAV) capsid candidates that were selected from extensive AAV libraries, isolated, and tested against references AAV2, AAV8, and LK-03. All capsids showed selective tropism and more potent transduction and gene expression than the reference capsids in human hepatocytes of a chimeric FRG mouse model. Separately, the Company presented preclinical data in a neonatal mouse model of hemophilia B. The mice treated with GeneRide demonstrated durable expression of human factor IX. By contrast, mice treated with canonical AAV showed rapid reduction of transgene expression due to episomal dilution and degradation in response to liver growth.

 

   

Initiation of Retrospective Natural History Study in MMA. This study is designed to evaluate disease progression in pediatric patients (born since 2010) with severe MMA managed according to current standard of care and those treated with liver transplantation. The study will be conducted at a small number of leading centers in the United States and Europe and will inform our discussions with regulators.

 

   

Strengthened leadership team by appointing Bryan Yoon, Esq., as chief administrative officer, general counsel and corporate secretary. Bryan was most recently the general counsel and secretary at Nightstar Therapeutics, a gene therapy company focused on inherited retinal diseases, from November 2017 until its acquisition by Biogen in June 2019. At Nightstar, he was responsible for the legal, compliance and intellectual property functions, in addition to leading all human resources activities, through a period of significant growth. Prior to Nightstar, Bryan worked at Intercept Pharmaceuticals, a leading biopharmaceutical company focusing on nonviral liver diseases, from January 2013 until November 2017, where he most recently served as senior vice president—legal affairs and secretary. Previously, Bryan worked at Mintz, Levin, Cohn, Ferris, Glovsky and Popeo P.C. and Simpson Thacher & Bartlett LLP, where he advised clients, including a number of life sciences companies, on a variety of corporate and other legal


 

matters. Bryan holds a B.A. in economics and an M.Eng. in operations research and industrial engineering from Cornell University. He received his J.D. from the University of Michigan Law School.

 

   

Signed lease for new lab and office premises to support GeneRide platform development and capabilities expansion. The new facilities at 65 Hayden Avenue in Lexington, Mass., will double the Company’s available space and will include office, state-of-the-art laboratory, and vivarium space. The Company will be adding internal development capabilities and will increase its capacity for in-house manufacturing of preclinical material. Combined with the new vivarium, this will allow for expanded characterization and development of its unique GeneRide platform. The new lease will replace the current headquarters at 99 Erie Street in Cambridge in April 2020.

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.

 

   

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

Third Quarter 2019 Financial Results

Three Months Ended September 30, 2019 and 2018

 

   

R&D Expenses: Research and development expenses for the three months ended September 30, 2019 were $8.9 million, compared to $2.4 million for the three months ended September 30, 2018. The increase of approximately $6.4 million was primarily due to an increase of approximately $4.8 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 $0.8 million in personnel-related costs related to an increase in headcount. Personnel-related costs for the three months ended September 30, 2019 included stock-based compensation expense of $0.2 million, compared to $0.1 million for the three months ended September 30, 2018.

 

   

G&A Expenses: General and administrative expenses were $2.2 million for the three months ended September 30, 2019, compared to $2.1 million for the three months ended September 30, 2018. The increase of approximately $0.1 million was primarily due to an increase in personnel-related costs, including salaries, stock-based compensation and bonuses of $0.3 million related to an increase in headcount and offset by a decrease in professional fees of $0.2 million related to non-recurring consulting expenses incurred as part of our October 2018 initial public offering. Stock-based compensation expense included in general and administrative expenses was $0.3 million and $0.2 million for the three months ended September 30, 2019 and 2018, respectively.


   

Net Loss: Net loss attributable to common stockholders was $10.9 million, or $0.48 per share, for the three months ended September 30, 2019, compared to a net loss attributable to common stockholders of $8.6 million, or $4.03 per share, for the same period last year.

 

   

Cash Position and Financial Guidance: Cash, cash equivalents and investments were $63.2 million as of September 30, 2019. The Company expects that its cash, cash equivalents and investments at September 30, 2019 are sufficient 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 September 30,     Nine Months Ended September 30,  
          2019                 2018                 2019                 2018        

OPERATING EXPENSES:

       

Research and development

  $ 8,858     $ 2,432     $ 22,278     $ 6,113  

General and administrative

    2,175       2,119       7,331       4,453  
 

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

    11,033       4,551       29,609       10,566  
 

 

 

   

 

 

   

 

 

   

 

 

 

LOSS FROM OPERATIONS

    (11,033     (4,551     (29,609     (10,566
 

 

 

   

 

 

   

 

 

   

 

 

 

OTHER INCOME (EXPENSE), NET:

       

Interest income

    389       75       1,243       204  

Interest expense

    (271     (1     (271     (2

Other expense, net

    (3     (154     (4     (158
 

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense), net

    115       (80     968       44  
 

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

    (10,918     (4,631     (28,641     (10,522

Income tax provision

    —         (38     (22     (38
 

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

  $ (10,918   $ (4,669   $ (28,663   $ (10,560
 

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to common stockholders—basic and diluted

  $ (10,918   $ (8,621   $ (28,663   $ (14,512
 

 

 

   

 

 

   

 

 

   

 

 

 

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

  $ (0.48   $ (4.03   $ (1.27   $ (7.39
 

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average common stock outstanding—basic and diluted

    22,677,205       2,138,160       22,491,282       1,963,976  
 

 

 

   

 

 

   

 

 

   

 

 

 

LogicBio Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(In thousands)

(Unaudited)

 

     As of  
     September 30,
2019
     December 31,
2018
 

Cash, cash equivalents and investemnts

   $ 63,161      $ 80,906  

Other assets

     3,926        2,004  
  

 

 

    

 

 

 

TOTAL ASSETS

   $ 67,087      $ 82,910  
  

 

 

    

 

 

 

Accounts payable, accrued expenses and other liabilities

   $ 13,889      $ 2,685  

Stockholders’ equity

     53,198        80,225  
  

 

 

    

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

   $ 67,087      $ 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