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): March 16, 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.)

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 March 16, 2020, LogicBio Therapeutics, Inc. issued a press release announcing its financial results for the year ended December 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 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 7.01 Regulation FD.

On March 16, 2020, the Company announced the appointment of Mark Enyedy to its board of directors. The Company also announced the departure of Tomer Kariv, Esq. from its board of directors due to time constrains related to his other business obligations. A copy of this press release is attached to this Current Report on Form 8-K as Exhibit 99.2 and is incorporated herein by reference.

The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.2 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act and shall not be deemed incorporated by reference in any filing under 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 March 16, 2020.
99.2    Press Release issued by LogicBio Therapeutics, Inc. on March 16, 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: March 16, 2020

EX-99.1

Exhibit 99.1

LogicBio Reports Full Year 2019 Financial Results and Provides Business Updates

CAMBRIDGE, Mass., March 16, 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 and provided a corporate update for the year ended December 31, 2019.

“2019 was a productive year for LogicBio marked by multi-faceted progress, including our new collaboration with Takeda to advance GeneRide in Crigler-Najjar, our newly announced second indication, and continued work to move our lead candidate, LB-001 towards the clinic,” said Fred Chereau, CEO of LogicBio. “We are focused on resolving the FDA’s questions on the LB-001 IND application as quickly as possible and remain firmly committed to bringing LB-001 to pediatric patients living with MMA as part of our broader mission to bring the promise of genomic medicines to children with rare diseases.”

In January 2020, we announced the submission of an IND to support the initiation of a Phase 1/2 clinical trial in pediatric patients with MMA, which the FDA placed on clinical hold. Subsequently, we received a letter from the FDA specifying its questions related to the clinical hold. The clinical hold was based on questions that were clinical and nonclinical in nature, including questions related to the studies conducted for our IND filing, but did not relate to chemistry, manufacturing, and controls. We expect to have interactions with the FDA regarding their questions through mid-2020, after which we plan to provide guidance on the anticipated timing for the initiation of the Phase 1/2 clinical trial for LB-001.

Business Highlights Include:

 

   

Established collaboration with Takeda to leverage the GeneRide platform in a second indication, 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. The LB-301 construct, utilizing the modularity of GeneRide, is expected to share several components with LB-001 to facilitate development. Those components include: LK-03 as the capsid; the albumin gene as the target genetic locus for integration; and a 2A peptide sequence to facilitate polycistronic expression and serve as a circulating biomarker.

 

   

Extended Sponsored Research Agreement with Oregon Health & Science University to Explore Translation of Pharmaceutically-Driven Selective Advantage of Future GeneRide Candidates. The initial phase of the research program provided proof-of-principle of enhanced selective advantage for cells edited by GeneRide in pilot murine experiments. This extension phase focuses on translating the enhancement strategy beyond murine models with the goal of enhancing the clinical translation of future GeneRide candidates and other approaches to genetic medicines.

 

   

Initiated Retrospective Natural History Study in MMA. This study is designed to evaluate disease progression in pediatric patients (born since 2010) with severe MMA, with the aim of informing LogicBio’s future development in MMA and its discussions with regulatory agencies.


   

Reported positive data on Next Generation Capsid Development program at European Society of Gene and Cell Therapy Annual Meeting. Data were presented from a set of novel, synthetic adeno-associated virus (AAV) capsid candidates 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. LogicBio, working in partnership with the Children’s Medical Research Institute, intends to advance this research and present additional findings at a scientific conference in 2020.

Full Year 2019 Financial Results

Twelve Months Ended December 31, 2019 and 2018

 

   

R&D Expenses: Research and development expenses for the year ended December 31, 2019 were $30.7 million, compared to $11.1 million for year ended December 31, 2018. The increase was primarily due to an increase of approximately $14.1 million related to external development and manufacturing expenses for our lead product candidate LB-001. Personnel-related costs for the year ended December 31, 2019 included stock-based compensation expense of $0.8 million compared to $0.3 million for the year ended December 31, 2018.

 

   

G&A Expenses: General and administrative expenses were $10.4 million for the year ended December 31, 2019, compared to $6.9 million for the year ended December 31, 2018. The increase was primarily due to increases in legal and professional fees and personnel-related costs primarily due to an increase in headcount. Stock-based compensation expense included in general and administrative expenses was $1.0 million and $0.8 million for the years ended December 31, 2019 and 2018, respectively.

 

   

Net Loss: Net loss was $40.1 million, or $1.78 per share, for the year ended December 31, 2019, compared to a net loss of $17.6 million, or $3.04 per share, for the year ended December 31, 2018.

 

   

Cash Position and Financial Guidance: Cash, cash equivalents and investments were $50.6 million as of December 31, 2019. Based upon our current operating plan, which takes into account expenditures that are contingent based on corporate developments, we believe that our cash and cash equivalents and short-term investments as of December 31, 2019 will enable us to fund our operating expenses and capital expenditure requirements into the first 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 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, 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; and the anticipated construct for LB-301 in Crigler-Najjar. 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.

Consolidated Statements of Operations

(In thousands, except share and per share data)

 

     Year Ended December 31,  
     2019     2018  

OPERATING EXPENSES:

    

Research and development

   $ 30,656     $ 11,079  

General and administrative

     10,385       6,864  
  

 

 

   

 

 

 

Total operating expenses

     41,041       17,943  
  

 

 

   

 

 

 

LOSS FROM OPERATIONS

     (41,041     (17,943
  

 

 

   

 

 

 

OTHER INCOME (EXPENSE), NET:

    

Interest income

     1,500       569  

Interest expense

     (546     (2

Other expense, net

     (19     (159
  

 

 

   

 

 

 

Total other income, net

     935       408  
  

 

 

   

 

 

 

Loss before income taxes

     (40,106     (17,535

Income tax provision

     (22     (86
  

 

 

   

 

 

 

Net loss

   $ (40,128   $ (17,621
  

 

 

   

 

 

 

Net loss per share—basic and diluted

   $ (1.78   $ (3.04
  

 

 

   

 

 

 

Weighted-average common stock outstanding—basic and diluted

     22,602,954       5,801,533  
  

 

 

   

 

 

 


LogicBio Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(In thousands)

 

     As of  
     December 31,
2019
     December 31,
2018
 

Cash, cash equivalents and investments

   $ 50,647      $ 80,906  

Other assets

     5,013        2,004  
  

 

 

    

 

 

 

TOTAL ASSETS

   $ 55,660      $ 82,910  
  

 

 

    

 

 

 

Accounts payable, accrued expenses and other liabilities

   $ 13,373      $ 2,685  

Stockholders’ equity

     42,287        80,225  
  

 

 

    

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

   $ 55,660      $ 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

EX-99.2

Exhibit 99.2

LogicBio Therapeutics Appoints Mark Enyedy to its Board of Directors

CAMBRIDGE, Mass., March 16, 2020 – LogicBio Therapeutics, Inc. (Nasdaq:LOGC), a genome editing company focused on developing medicines to durably treat rare diseases in pediatric patients, today announced that Mark Enyedy has been appointed to its Board of Directors, effective as of March 17, 2020. Mr. Enyedy, who brings over 25 years of deep experience in biotech management, strategy, and corporate development, currently serves as President and Chief Executive Officer of Immunogen, Inc. Tomer Kariv, Esq., co-founder and Chief Executive Officer of Pontifax, is stepping down due to time commitments relating to his other business obligations after serving as a member of the Board of Directors since June 2017.

“We look forward to benefiting from Mark’s extensive general management, business development, and legal experience in the life science industry as we continue the development of our product candidates,” said Fred Chereau, CEO of LogicBio. “We are also deeply grateful for Tomer’s innumerable contributions in advising LogicBio during a period of rapid growth.”

“LogicBio’s mission of bringing genetic medicines to children with rare diseases fits nicely with my passion to bring hope and improve outcomes for patients with high unmet need. I look forward to partnering closely with Fred, the members of the Board, and the leadership team in building on the strong foundation LogicBio has established,” Mr. Enyedy said.

Mark Enyedy has served as President and Chief Executive Officer of lmmunoGen since 2016. Prior to joining ImmunoGen, he served in various executive capacities at Shire PLC from 2013 to 2016, including as Executive Vice President and Head of Corporate Development from 2014 to 2016, where he led Shire’s strategy, M&A, and corporate planning functions and provided commercial oversight of Shire’s pre-Phase 3 portfolio. Prior to joining Shire, he served as Chief Executive Officer and a director of Proteostasis Therapeutics, Inc., a biopharmaceutical company, from 2011 to 2013. Prior to joining Proteostasis, he served for 15 years at Genzyme Corporation, most recently as President of the Transplant, Oncology, and Multiple Sclerosis divisions. Mr. Enyedy holds a J.D. from Harvard Law School and practiced law prior to joining Genzyme. Mr. Enyedy is also a director of Akebia Therapeutics and The American Cancer Society of Eastern New England. Within the past five years, he also served as a director of Fate Therapeutics, Inc. and Keryx Biopharmaceuticals, Inc.

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.

Contacts:

Brian Luque

Associate Director, Investor Relations

bluque@logicbio.com

951-206-1200

Stephanie Simon

Ten Bridge Communications

stephanie@tenbridgecommunications.com

617-581-9333