8-K
false 0001664106 0001664106 2020-11-09 2020-11-09

 

 

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 9, 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 November 9, 2020, LogicBio Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarterly period ended September 30, 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, 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 9, 2020.
104    Cover Page Interactive Data File (embedded with Inline XBRL document)


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 Jaffe

  Matthias Jaffe
Chief Financial Officer

Date: November 9, 2020

EX-99.1

Exhibit 99.1

 

LOGO

LogicBio Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update

- IND for LB-001 in methylmalonic acidemia (MMA) cleared in August 2020, with first patient in Phase

1/2 SUNRISE trial expected to be enrolled in early 2021

- Fast Track designation for LB-001 in MMA received in November 2020

- First follow-on offering post-IPO closed in October 2020

LEXINGTON, Mass., Nov. 9, 2020 (GLOBE NEWSWIRE) — LogicBio Therapeutics, Inc. (Nasdaq:LOGC) (LogicBio or the Company), a company dedicated to extending the reach of genetic medicine with pioneering targeted delivery platforms, today reported financial results for the quarter ended September 30, 2020 and provided a business update.

“LogicBio has recently marked several important achievements, which could set the stage for exciting news from our company in the quarters to come,” said Frederic Chereau, President and CEO. “Over the last several months, LogicBio made significant advances in its LB-001 program in methylmalonic acidemia (MMA), with the clearance of the IND and the receipt of Fast Track designation for LB-001 in MMA. Following our $48.3 million follow-on public offering in early October, we believe we are well-positioned financially to deliver on our upcoming milestones.” Mr. Chereau continued, “The Phase 1/2 SUNRISE trial is designed to treat MMA patients at a young age when gene editing could potentially make a meaningful, life-long difference. We continue to anticipate the enrollment of our first patient in the SUNRISE trial in early 2021, and we eagerly look forward to updating both the clinical community and investors of our progress as 2021 unfolds.” Mr. Chereau concluded by saying, “In addition to our exciting clinical program, we have extended our collaboration with the Children’s Medical Research Institute of Australia to continue to develop our Next Generation Capsid platform, which has already yielded novel liver-tropic capsids that we believe are superior to ones that are currently used in the clinic. We also anticipate sharing further data on our novel capsids in early 2021.”

Anticipated LogicBio Milestones for 2021:

LB-001 for MMA

 

   

Early 2021: First patient enrollment in Phase 1/2 SUNRISE trial

 

   

Mid 2021: Operational update on dose escalation and age de-escalation

 

   

Mid 2021: Data from retrospective natural history study in MMA

 

   

Late 2021: Interim data from SUNRISE trial

Pipeline

 

   

Early 2021: Translational data on GeneRide and Next Generation Capsid Platforms


   

2021: Nomination of next internal development candidate

Third Quarter 2020 Financial Results

Three Months Ended September 30, 2020 and 2019

 

   

R&D Expenses: Research and development expenses for the three months ended September 30, 2020 were $5.5 million, compared to $8.9 million for the three months ended September 30, 2019. The decrease of approximately $3.4 million was primarily due to a decrease of approximately $3.8 million in external development and manufacturing expenses for our lead product candidate, LB-001. This decrease was partially offset by an increase of $0.5 million in other research and development expenses as we increased our overall research and development activities related GeneRide and our Next Generation Capsids.

 

   

G&A Expenses: General and administrative expenses were $3.2 million for the three months ended September 30, 2020, compared to $2.2 million for the three months ended September 30, 2019. The increase of approximately $1.0 million was primarily driven by an increase of $0.4 million in stock-based compensation expense and a $0.4 million increase in legal fees and professional services.

 

   

Net Loss: Net loss was $8.0 million, or $0.34 per share, for the three months ended September 30, 2020, compared to a net loss of $10.9 million, or $0.48 per share, for the three months ended September 30, 2019.

 

   

Cash Position and Financial Guidance: As of September 30, 2020, we had cash and cash equivalents of $32.3 million, which we believe, combined with the net proceeds of $45.2 million from our October follow-on offering, will be sufficient to fund our operating expenses and capital expenditures for at least the next twelve months.

About LogicBio Therapeutics

LogicBio Therapeutics is dedicated to extending the reach of genetic medicine with pioneering targeted delivery platforms. LogicBio’s proprietary genome editing technology platform, GeneRide, enables the site-specific integration of a therapeutic transgene without nucleases or exogenous promoters by harnessing the native process of homologous recombination. LogicBio has received FDA clearance for the first-in-human clinical trial of LB-001, a wholly owned genome editing program leveraging GeneRide for the treatment of methylmalonic acidemia. Patient enrollment is expected to begin in early 2021. In addition, LogicBio has a collaboration with Takeda to research and develop LB-301, an investigational therapy leveraging GeneRide for the treatment of the rare pediatric disease Crigler-Najjar syndrome.

LogicBio is also developing a Next Generation Capsid platform for use in gene editing and gene therapies. Data presented have shown that the capsids deliver highly efficient functional transduction of human hepatocytes with improved manufacturability with low levels of pre-existing neutralizing antibodies in human samples. Top-tier capsid candidates from this effort demonstrated significant improvements over benchmark AAVs currently in clinical development. LogicBio is developing these highly potent vectors for internal development candidates and potentially for business development collaborations.


LogicBio is headquartered in Lexington, Mass. 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 initiate, advance and complete its planned Phase 1/2 SUNRISE clinical trial of LB-001 in MMA and the potential benefits to patients of LB-001; the timing, progress and results of the Company’s research and development activities, including those related to the GeneRide technology platform and Next Generation Capsid Program; its plans for LB-301 in Crigler-Najjar; and the sufficiency of our cash on hand to fund our operating expenses and capital expenditures. 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, the impact of the COVID-19 pandemic on the Company’s ability to progress with its research, development, manufacturing and regulatory efforts, including the Company’s plans to initiate, advance and complete its Phase 1/2 clinical trial for LB-001 in MMA, 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, the Company’s Quarterly Report on Form 10-Q filed on May 11, 2020, 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 Balance Sheets

(In thousands)

(Unaudited)

 

     As of  
     September 30, 2020      December 31, 2019  

Cash, cash equivalents and investments

   $ 32,285      $ 50,647  

Other assets

     9,521        5,013  
  

 

 

    

 

 

 

TOTAL ASSETS

   $ 41,806      $ 55,660  
  

 

 

    

 

 

 

Accounts payable, accrued expenses and other liabilities

   $ 19,515      $ 13,373  

Stockholders’ equity

     22,291        42,287  
  

 

 

    

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

   $ 41,806      $ 55,660  
  

 

 

    

 

 

 


Logic Bio Therapeutics, Inc.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share amounts)

(unaudited)

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2020     2019     2020     2019  

REVENUE

        

Service revenue

   $ 926     $ —       $ 2,912     $ —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     926       —         2,912       —    

OPERATING EXPENSES

        

Research and development

     5,492       8,858       18,560       22,278  

General and administrative

     3,200       2,175       9,421       7,331  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     8,692       11,033       27,981       29,609  
  

 

 

   

 

 

   

 

 

   

 

 

 

LOSS FROM OPERATIONS

     (7,766     (11,033     (25,069     (29,609
  

 

 

   

 

 

   

 

 

   

 

 

 

OTHER INCOME (EXPENSE), NET:

        

Interest income

     2       389       179       1,243  

Interest expense

     (276     (271     (821     (271

Other income (expense), net

     1       (3     (10     (4
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other (expense) income, net

     (273     115       (652     968  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (8,039     (10,918     (25,721     (28,641

Income tax provision

     —         —         —         (22
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (8,039   $ (10,918   $ (25,721   $ (28,663
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share—basic and diluted

   $ (0.34   $ (0.48   $ (1.10   $ (1.27
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average common stock outstanding—basic and diluted

     23,599,052       22,677,205       23,367,804       22,491,282  
  

 

 

   

 

 

   

 

 

   

 

 

 

Contact:

Matthias Jaffe

Chief Financial Officer

mjaffe@logicbio.com

(617) 245-0399