UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2019March 31, 2020

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period fromto

Commission File Number:001-38707

 

LogicBio Therapeutics, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

 

Delaware

47-1514975

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

99 Erie St., Cambridge,65 Hayden Avenue, 2nd Floor, Lexington, MA 0213902421

(Address of principal executive offices) (Zip code)

(617)245-0399

(Registrant’s telephone number, including area code)

 

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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes      No  

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of RegulationS-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes      No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, anon-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

Accelerated filer                  

Non-accelerated filer

Smaller reporting company

Emerging growth company

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.  

Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Exchange Act).  Yes  No  

As of August 8, 2019,May 7, 2020, the registrant had 22,668,07623,351,598 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 




SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report onForm 10-Q contains forward-looking statements. All statements other than statements of historical fact are “forward-looking statements” for purposes of this Quarterly Report on Form 10-Q. In some cases, you can identify theseforward-looking statements by forward-looking wordsterminology such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect,” or similar expressions, or the negative or plural of these words or expressions. These forward-looking statements include statements concerning the following:

the initiation, cost, timing, progress and results of our current and future research and development activities and preclinical studies and potential future clinical trials;trials, including our plans to resolve the clinical hold placed by the U.S. Food and Drug Administration, or the FDA, on the investigational new drug application, or IND, for LB-001;  

potential attributes and benefits of our GeneRide technology platform and our existing or future product candidates;

potential attributes and benefits of our GeneRide technology platform and our product candidate and any future product candidates;

our ability to take advantage of the modular nature of our GeneRide platform to simplify and accelerate development of new product candidates;

the potential benefits of strategic partnership agreements and our ability to enter into selective strategic partnership arrangements;

the timing of, and our ability to obtain and maintain, regulatory approvals for our product candidate and anyexisting or future product candidates;

our ability to quickly and efficiently identify and develop additional product candidates;

our ability to advance any product candidate into and successfully complete clinical trials;

our intellectual property position, including with respect to our trade secrets and the duration of our patent protection; and

our estimates regarding expenses, future revenues, capital requirements, the sufficiency of our current and expected cash resources and our need for additional financing.

These statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in greater detail under Part I, Item 1A. Risk Factors in our Annual Report on Form10-K for the year ended December 31, 20182019 filed with the Securities and Exchange Commission on April 1, 2019,March 16, 2020, and under Part II, Item 1A. Risk Factors in this Quarterly Report on Form 10-Q, each as may be amended or updated in our Quarterly Reports on Form10-Q. You In particular, while we expect the COVID-19 pandemic to adversely affect our business operations and financial results, the extent of the impact on our ability to progress with our research, development, manufacturing and regulatory efforts, including our plans to resolve the clinical hold placed by the FDA on the IND for LB-001, and the value of and market for our 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. Any forward-looking statement in this Quarterly Report on Form 10-Q reflects our current view with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, industry and future growth. Given these uncertainties, you should not rely uponon these forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, weWe cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we are underassume no dutyobligation to update or revise anythese forward-looking statements whether as a result offor any reason, even if new information future events or otherwise, afterbecomes available in the date of this Quarterly Report onForm 10-Q, and you should not rely on statements contained herein as representing our views as of any date subsequent to the date of this Quarterly Report on Form10-Q.future.

Unless the context otherwise requires, the terms “LogicBio,” “LogicBio Therapeutics, Inc.,” the “Company,” “we,” “us,” “our” and similar references in this Quarterly Report on Form10-Q refer to LogicBio Therapeutics, Inc. and its subsidiaries.


PART I—FINANCIALFINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited).

LogicBio Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share data)

 

  June 30,
2019
 December 31,
2018
 

 

March 31, 2020

 

 

December 31, 2019

 

ASSETS

   

 

 

 

 

 

 

 

 

CURRENT ASSETS:

   

 

 

 

 

 

 

 

 

Cash and cash equivalents

  $25,456  $80,906 

 

$

43,153

 

 

$

33,107

 

Short-term investments

   38,200   —   

 

 

 

 

 

17,540

 

Prepaid expenses and other current assets

   1,990  1,268 

 

 

3,038

 

 

 

2,045

 

Restricted cash

   146   —   

 

 

146

 

 

 

146

 

  

 

  

 

 

Total current assets

   65,792  82,174 

 

 

46,337

 

 

 

52,838

 

Property and equipment, net

   1,271  590 

 

 

1,591

 

 

 

1,696

 

Restricted cash

   —    146 

 

 

622

 

 

 

622

 

Operating lease right-of-use asset

   967   —   

 

 

199

 

 

 

504

 

  

 

  

 

 

TOTAL ASSETS

  $68,030  $82,910 

 

$

48,749

 

 

$

55,660

 

  

 

  

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

   

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

   

 

 

 

 

 

 

 

 

Accounts payable

  $1,657  $1,168 

 

$

2,181

 

 

$

624

 

Accrued expenses and other current liabilities

   2,962  1,517 

 

 

1,934

 

 

 

2,939

 

  

 

  

 

 

Deferred revenue

 

 

1,065

 

 

 

 

Total current liabilities

   4,619  2,685 

 

 

5,180

 

 

 

3,563

 

Long-term debt, net of issuance costs and discount

 

 

9,862

 

 

 

9,810

 

Total liabilities

 

 

15,042

 

 

 

13,373

 

STOCKHOLDERS’ EQUITY:

   

 

 

 

 

 

 

 

 

Common stock, par value of $0.0001 per share; 175,000,000 shares authorized as of June 30, 2019 and December 31, 2018, respectively; 22,522,516 and 22,188,393 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively

   3  3 

Preferred stock, par value of $0.0001 per share; 25,000,000 shares authorized;

no shares issued and outstanding as of March 31, 2020 and December 31, 2019.

 

 

 

 

 

 

Common stock, par value of $0.0001 per share; 175,000,000 shares authorized;

23,216,661 and 23,036,943 shares issued and outstanding as of March 31, 2020 and

December 31, 2019, respectively

 

 

3

 

 

 

3

 

Additional paid-in capital

   108,362  107,473 

 

 

110,529

 

 

 

109,640

 

Accumulated other comprehensive income (loss)

   33  (9

Accumulated other comprehensive income

 

 

 

 

 

14

 

Accumulated deficit

   (44,987 (27,242

 

 

(76,825

)

 

 

(67,370

)

  

 

  

 

 

Total stockholders’ equity

   63,411  80,225 

 

 

33,707

 

 

 

42,287

 

  

 

  

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

  $68,030  $82,910 

 

$

48,749

 

 

$

55,660

 

  

 

  

 

 

See notes to unaudited condensed consolidated financial statements.


LogicBio Therapeutics, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share data)

 

 

Three Months Ended March 31,

 

  Three Months Ended June 30, Six Months Ended June 30, 

 

2020

 

 

2019

 

  2019 2018 2019 2018 

OPERATING EXPENSES:

     

REVENUE

 

 

 

 

 

 

 

 

Service revenue

 

$

1,021

 

 

$

 

Total revenue

 

 

1,021

 

 

 

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

Research and development

  $7,934  $2,226  $13,420  $3,681 

 

 

7,173

 

 

 

5,486

 

General and administrative

   2,524  1,416  5,156  2,334 

 

 

3,192

 

 

 

2,632

 

  

 

  

 

  

 

  

 

 

Total operating expenses

   10,458  3,642  18,576  6,015 

 

 

10,365

 

 

 

8,118

 

  

 

  

 

  

 

  

 

 

LOSS FROM OPERATIONS

   (10,458 (3,642 (18,576 (6,015

 

 

(9,344

)

 

 

(8,118

)

  

 

  

 

  

 

  

 

 

OTHER INCOME, NET:

     

Interest income, net

   411  60  854  128 

OTHER INCOME (EXPENSE), NET:

 

 

 

 

 

 

 

 

Interest income

 

 

167

 

 

 

443

 

Interest expense

 

 

(272

)

 

 

 

Other expense, net

   (1 (7 (1 (4

 

 

(6

)

 

 

 

  

 

  

 

  

 

  

 

 

Total other income, net

   410  53  853  124 
  

 

  

 

  

 

  

 

 

Total other income (expense), net

 

 

(111

)

 

 

443

 

Loss before income taxes

   (10,048 (3,589 (17,723 (5,891

 

 

(9,455

)

 

 

(7,675

)

Income tax benefit (provision)

   —    2  (22  —   
  

 

  

 

  

 

  

 

 

Income tax provision

 

 

 

 

 

(22

)

Net loss

  $(10,048 $(3,587 $(17,745 $(5,891

 

$

(9,455

)

 

$

(7,697

)

  

 

  

 

  

 

  

 

 

Net loss attributable to common stockholders—basic and diluted (Note 9)

  $(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
  

 

  

 

  

 

  

 

 

Net loss per share—basic and diluted

 

$

(0.41

)

 

$

(0.34

)

Weighted-average common stock outstanding—basic and diluted

   22,479,511  1,962,570  22,396,780  1,875,440 

 

 

23,175,802

 

 

 

22,313,129

 

  

 

  

 

  

 

  

 

 

See notes to unaudited condensed consolidated financial statements.


LogicBio Therapeutics, Inc.

Condensed Consolidated Statements of Comprehensive Loss

(In thousands)

 

  Three Months Ended
June 30,
 Six Months Ended
June 30,
 

 

Three Months Ended March 31,

 

  2019 2018 2019 2018 

 

2020

 

 

2019

 

Net loss

  $(10,048 $(3,587 $(17,745 $(5,891

 

$

(9,455

)

 

$

(7,697

)

Other comprehensive income:

     

 

 

 

 

 

 

 

 

Unrealized gain on investments

   27   —    36   —   

 

 

 

 

 

9

 

Foreign currency translation adjustment

   3  1  6  8 

 

 

 

 

 

3

 

  

 

  

 

  

 

  

 

 

Comprehensive loss

  $(10,018 $(3,586 $(17,703 $(5,883

 

$

(9,455

)

 

$

(7,685

)

  

 

  

 

  

 

  

 

 

See notes to unaudited condensed consolidated financial statements.


LogicBio Therapeutics, Inc.

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(In thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Convertible Preferred Stock  Common Stock
$0.0001 Par Value
  Additional
Paid-in
Capital
 Accumulated
Other
Comprehensive
(Loss) Income
 Accumulated
Deficit
 Total
Stockholders’
(Deficit) Equity
 

 

Common Stock

$0.0001 Par Value

 

 

Additional

Paid-in

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders’

 

 Convertible Preferred Stock
$0.0001 Par Value Series A
 Convertible Preferred Stock
$0.0001 Par Value Series B
 
 Shares Amount Shares Amount  Shares Amount 

BALANCE, January 1, 2018

 2,976,190  $4,359  19,541,465  $28,703   1,606,360  $1  $1,035  $(14 $(9,621 $(8,599

Vesting of restricted stock

  —     —     —     —     173,717   —     —     —     —     —   

Foreign currency translation adjustment

  —     —     —     —     —     —     —    7   —    7 

Stock-based compensation expense

  —     —     —     —     —     —    88   —     —    88 

Net loss

  —     —     —     —     —     —     —     —    (2,304 (2,304
 

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

BALANCE, March 31, 2018

 2,976,190  4,359  19,541,465  28,703   1,780,077  1  1,123  (7 (11,925 (10,808

Vesting of restricted stock

  —     —     —     —     162,569   —     —     —     —     —   

Foreign currency translation adjustment

  —     —     —     —     —     —     —    1   —    1 

Stock-based compensation expense

  —     —     —     —     —     —    145   —     —    145 

Net loss

  —     —     —     —     —     —     —     —    (3,587 (3,587
 

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

BALANCE, June 30, 2018

 2,976,190  $4,359  19,541,465  $28,703   1,942,646  $1  $1,268  $(6 $(15,512 $(14,249
 

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

(Loss) Income

 

 

Deficit

 

 

Equity

 

BALANCE, January 1, 2019

  —    $—     —    $—     22,188,393  $3  $107,473  $(9 $(27,242 $80,225 

 

 

22,188,393

 

 

$

3

 

 

$

107,473

 

 

$

(9

)

 

$

(27,242

)

 

$

80,225

 

Vesting of restricted stock

  —     —     —     —     160,337   —     —     —     —     —   

 

 

160,337

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on investments

  —     —     —     —     —     —     —    9   —    9 

 

 

 

 

 

 

 

 

 

 

 

9

 

 

 

 

 

 

9

 

Foreign currency translation adjustment

  —     —     —     —     —     —     —    3   —    3 

 

 

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

3

 

Stock-based compensation expense

  —     —     —     —     —     —    276   —     —    276 

 

 

 

 

 

 

 

 

276

 

 

 

 

 

 

 

 

 

276

 

Net loss

  —     —     —     —     —     —     —     —    (7,697 (7,697

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,697

)

 

 

(7,697

)

 

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

BALANCE, March 31, 2019

  —     —     —     —     22,348,730  3  107,749  3  (34,939 72,816 

 

 

22,348,730

 

 

$

3

 

 

$

107,749

 

 

$

3

 

 

$

(34,939

)

 

$

72,816

 

BALANCE, January 1, 2020

 

 

23,036,943

 

 

$

3

 

 

$

109,640

 

 

$

14

 

 

$

(67,370

)

 

$

42,287

 

Vesting of restricted stock

  —     —     —     —     160,332   —     —     —     —     —   

 

 

160,340

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of options

  —     —     —     —     13,454   —    82   —     —    82 

 

 

19,378

 

 

 

 

 

 

84

 

 

 

 

 

 

 

 

 

84

 

Unrealized gain on investments

  —     —     —     —     —     —     —    27   —    27 

Foreign currency translation adjustment

  —     —     —     —     —     —     —    3   —    3 

Realized gain on investments

 

 

 

 

 

 

 

 

 

 

 

(14

)

 

 

 

 

 

(14

)

Stock-based compensation expense

  —     —     —     —     —     —    531   —     —    531 

 

 

 

 

 

 

 

 

805

 

 

 

 

 

 

 

 

 

805

 

Net loss

  —     —     —     —     —     —     —     —    (10,048 (10,048

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,455

)

 

 

(9,455

)

 

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

BALANCE, June 30, 2018

  —    $—     —    $—     22,522,516  $3  $108,362  $33  $(44,987 $63,411 
 

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

BALANCE, March 31, 2020

 

 

23,216,661

 

 

$

3

 

 

$

110,529

 

 

$

 

 

$

(76,825

)

 

$

33,707

 

See notes to unaudited condensed consolidated financial statements.


LogicBio Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(In thousands)

 

  Six Months Ended
June 30,
 

 

Three Months Ended March 31,

 

  2019 2018 

 

2020

 

 

2019

 

CASH FLOWS FROM OPERATING ACTIVITIES:

   

 

 

 

 

 

 

 

 

Net loss

  $(17,745 $(5,891

 

$

(9,455

)

 

$

(7,697

)

Adjustments to reconcile net loss to net cash used in operating activities:

   

 

 

 

 

 

 

 

 

Depreciation expense

   104  39 

 

 

105

 

 

 

39

 

Net amortization of premiums and discounts on investments

   (337  —   

 

 

26

 

 

 

(95

)

Stock-based compensation expense

   807  233 

 

 

805

 

 

 

276

 

Non-cash interest expense

 

 

52

 

 

 

 

Non-cash lease expense

   567   —   

 

 

305

 

 

 

274

 

Changes in operating assets and liabilities:

   

 

 

 

 

 

 

 

 

Prepaid expenses and other current assets

   (683 (376

 

 

(993

)

 

 

(498

)

Other assets

   —    115 

 

 

 

 

 

(57

)

Accounts payable

   448  (273

 

 

1,557

 

 

 

201

 

Accrued expenses and other current liabilities

   (123 (163

 

 

(1,005

)

 

 

(675

)

  

 

  

 

 

Deferred revenue

 

 

1,065

 

 

 

 

Net cash used in operating activities

   (16,962 (6,316

 

 

(7,538

)

 

 

(8,232

)

  

 

  

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

   

 

 

 

 

 

 

 

 

Purchase of investments

   (48,028  —   

 

 

 

 

 

(44,562

)

Maturities of investments

   10,200   —   

 

 

17,500

 

 

 

 

Purchase of property and equipment

   (749 (15

 

 

 

 

 

(247

)

  

 

  

 

 

Net cash used in investing activities

   (38,577 (15
  

 

  

 

 

Net cash provided by (used in) investing activities

 

 

17,500

 

 

 

(44,809

)

CASH FLOWS FROM FINANCING ACTIVITIES:

   

 

 

 

 

 

 

 

 

Proceeds from exercise of stock options

   82   —   

 

 

84

 

 

 

 

  

 

  

 

 

Net cash provided by financing activities

   82   —   

 

 

84

 

 

 

 

  

 

  

 

 

Effect on foreign exchange rates on cash and cash equivalents

   7  17 

 

 

 

 

 

5

 

NET DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH

   (55,450 (6,314

NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH

 

 

10,046

 

 

 

(53,036

)

Cash, cash equivalents and restricted cash at beginning of year

   81,052  24,575 

 

 

33,875

 

 

 

81,052

 

  

 

  

 

 

Cash, cash equivalents and restricted cash at end of period

  $25,602  $18,261 

 

$

43,921

 

 

$

28,016

 

  

 

  

 

 

RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH

   

 

 

 

 

 

 

 

 

Cash and cash equivalents

  $25,456  $18,261 

 

$

43,153

 

 

$

27,870

 

Restricted cash

   146   —   
  

 

  

 

 

Short-term restricted cash

 

 

146

 

 

 

146

 

Long-term restricted cash

 

 

622

 

 

 

 

Total cash, cash equivalents and restricted cash

  $25,602  $18,261 

 

$

43,921

 

 

$

28,016

 

  

 

  

 

 

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:

   

 

 

 

 

 

 

 

 

Cash paid for taxes

  $4  $84 
  

 

  

 

 

Cash paid for interest

 

$

220

 

 

$

 

Cash paid for income taxes

 

$

 

 

$

31

 

SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES:

 

 

 

 

 

 

 

 

Right-of-use assets obtained in exchange for operating lease obligation

  $1,323  $—   

 

$

 

 

$

1,323

 

  

 

  

 

 

Property and equipment purchases in accounts payable

  $56  $—   
  

 

  

 

 

Deferred financing costs in accounts payable and accrued expenses

  $39  $—   
  

 

  

 

 

Property and equipment purchases in accounts payable and accrued expenses

 

$

 

 

$

81

 

See notes to unaudited condensed consolidated financial statements.


LogicBio Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(In thousands, except share and per share data)

1. NATURE OF BUSINESS AND BASIS OF PRESENTATION

Business Overview

LogicBio Therapeutics, Inc. (“LogicBio” or the “Company”) was incorporated in 2014 as a Delaware corporation. Its principal offices are in Cambridge,Lexington, Massachusetts. The Company is a genome editing company focused on developing medicines to durably treat rare diseases in pediatric patients with significant unmet medical need, using GeneRide, its proprietary technology platform. GeneRide technology is designed to precisely and stably integrate corrective genes into a patient’s genome to provide a durable therapeutic effect. The Company has demonstrated proof of concept of its therapeutic platform in animal models for a number of diseases and is focusing on its lead product candidate,LB-001, for the treatment of methylmalonic acidemia,Methylmalonic Acidemia (“MMA”), a life-threatening disease that presents at birth.

On October 23, 2018,In January 2020, the Company completedannounced the submission of an initial public offeringinvestigational new drug application (“IPO”IND”) to support the initiation of a Phase 1/2 clinical trial for LB-001 in pediatric patients with MMA, which the FDA has placed on clinical hold. Subsequently, the Company 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 the Company’s IND filing, but did not relate to chemistry, manufacturing, and controls. The Company expects to have interactions with the FDA regarding their questions through mid-2020, after which the Company issued and sold 8,050,000 sharesplans to provide guidance on the anticipated timing for the initiation of the Phase 1/2 clinical trial for LB-001.

Since its inception, the Company has devoted the majority of its common stock, including 1,050,000 shares pursuantefforts to the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $10.00 per share, for aggregate gross proceeds of $80,500.business planning, research and development, developing markets, raising capital, and recruiting management and technical staff. The Company received approximately $72,300 in net proceeds after deducting underwriting discountsis subject to a number of risks similar to those of other companies conducting high-risk, early-stage research and commissionsdevelopment of product candidates. Principal among these risks are a dependency on key individuals and offering costs.

Uponintellectual property, competition from other products and companies, and the closing of the IPO, all outstanding shares of convertible preferred stock automatically converted into 11,789,775 shares of common stock at the applicable conversion ratio then in effect. Subsequent to the closing of the IPO, there were no shares of convertible preferred stock outstanding.

Management believes that the Company’s existing cash, cash equivalents and investments at June 30, 2019, togethertechnical risks associated with the net proceeds received under the Loan Agreement entered into on July 2, 2019 (Note 12), are projected to fund thesuccessful research, development and clinical manufacturing of its product candidates. The Company’s planned operations into 2021. In the absence of a significant source of recurring revenue, the continued viability of the Company beyond that pointsuccess is dependent onupon its ability to continue to raise additional capital in order to fund ongoing research and development, meet its obligations and, ultimately, obtain regulatory approval of its products, successfully commercialize its products, generate revenue and attain profitable operations.

COVID-19 Impact

The Company is closely monitoring the COVID-19 pandemic in order to ensure the safety of its personnel and to continue advancing its research and development activities. Since mid-March, the Company has ceased all business travel, non-laboratory employees have been working remotely, and the Company has arranged laboratory employees to work in shifts to continue in-house research and development activities. The Company plans to maintain these or similar restrictions until it believes employees can fully resume such activities in accordance with federal, state and local requirements and guidelines.

The COVID-19 pandemic did not have a material impact on the Company’s results of operations, cash flow and financial position as of and for the three months ended March 31, 2020. However, the full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial position will depend on future developments that are uncertain and cannot be accurately predicted.

Liquidity and Capital Resources

During the years ended December 31, 2019 and 2018, the Company incurred net losses of $40,128 and $17,621, respectively, and reported cash used in operations totaling $38,750 and $15,267, respectively.  In addition, as of December 31, 2019, the Company had an accumulated deficit of $67,370. The Company expects to continue to generate operating losses and use cash in operations for the foreseeable future.  As of March 31, 2020, the Company had cash and cash equivalents of $43,153 which management believes will be sufficient to fund its operating expenses and capital expenditure requirements through the second quarter of 2021. However, based on the Company’s operating losses since inception, the expectation of continued operating losses for the foreseeable future, and the need to raise additional capital to finance its operations.future operations, it has been deemed there is substantial doubt about the Company’s ability to continue as a going concern within one year from the date these condensed consolidated financial statements are issued.

The Company will require substantial additional capital to fund its research and development and ongoing operating expenses. Management’s plans to mitigate this risk include raising additional capital through equity or debt financings, or through


strategic transactions. These plans may also include the possible deferral of certain operating expenses unless and until additional capital is received. There can be no assurance that the Company will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to the Company, or that the Company will be successful in deferring certain operating expenses. While there can be no assurance the Company will be able to obtain sufficientsuccessfully reduce operating expenses or raise additional capital, to covermanagement believes its costs on acceptable terms, if at all.historical success in managing cash flows and obtaining capital will continue in the foreseeable future.

The accompanying unaudited condensed consolidated financial statements ashave been prepared on a going concern basis, which contemplates the realization of June 30, 2019assets and forsatisfaction of liabilities in the threeordinary course of business. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and six months ended June 30, 2019classification of recorded asset amounts or the amounts and 2018classification of liabilities that might result from the outcome of this uncertainty.

Basis of Presentation

The accompanying condensed consolidated financial statements have been prepared by the Company in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form10-K for the year ended December 31, 2018,2019, filed with the SEC on April 1, 2019.March 16, 2020.

The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements. In the opinion of management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments which are necessary for a fair statement of the Company’s financial position as of June 30, 2019,March 31, 2020, consolidated results of operations for the three and six months ended June 30,March 31, 2020 and 2019 and 2018 and cash flows for the sixthree months ended June 30, 2019 and 2018.March 31, 2020. Such adjustments are of a normal and recurring nature. The results of operations for the three and six months ended June 30, 2019March 31, 2020 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2019.2020.

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited consolidated financial statements and the notes thereto, which are included in the Company’s Annual Report on Form10-K for the year ended December 31, 2018,2019, filed with the SEC on April 1, 2019.March 16, 2020. Since the date of those financial statements, there have been no material changes to its significant accounting policies other than the Company’s adoption of ASC 842 (defined below) and the Company’s significant accounting policy over investments, both ofrevenue recognition under ASC 606 (defined below) which areis discussed in this note.

LeasesRevenue Recognition

EffectiveTo date the Company’s only revenue has consisted of service revenue, all of which is attributable to research cost reimbursement under the Company’s January 1, 2019,2020 research agreement with Takeda Pharmaceutical Company Limited (“Takeda”) for the development of product candidate LB-301 to treat Crigler-Najjar Syndrome (the “Takeda Agreement”). The Company adopted ASC Topic 842,Leases (“ASC 842”), usinghas not generated any revenue from product sales and does not expect to generate any revenue from product sales for the modified retrospective method and utilized the effective date as its date of initial application, with prior periods presentedforeseeable future.

The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”). ASC 606 applies to all contracts with customers, except for contracts that are within the previous guidance underscope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under ASC 840,Leases (“ASC 840”).

At the inception of an arrangement,606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps:

(i)

identification of the promised goods or services in the contract;

(ii)

determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract;


(iii)

measurement of the transaction price, including the constraint on variable consideration;

(iv)

allocation of the transaction price to the performance obligations; and

(v)

recognition of revenue when (or as) each performance obligation is satisfied.

If a contract is determined to be within the scope of ASC 606 at inception, the Company assesses the goods or services promised within such contract, determines which of those goods and services are performance obligations, and assesses whether each promised good or service is distinct. The Company may provide options to additional items in such arrangements, which are accounted for as separate contracts when the arrangement is or containscustomer elects to exercise such options, unless the option provides a leasematerial right to the customer. The Company determines transaction price based on the unique facts and circumstances presentamount of consideration the Company expects to receive for transferring the promised goods or services in the arrangement. Most leases withcontract. Consideration may be fixed, variable, or a term greater than one year are recognized on the balance sheet as a

combination of both. right-of-use asset and a current andnon-current lease liability, as applicable. The Company elected notthen allocates the transaction price to recognize on the balance sheet leases with terms of one year or less. The Company typically only includes an initial lease term in its assessment of a leasing arrangement. Options to renew a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew the lease. The Company remeasures and relocates the consideration in a contract when there is a modification of a lease that is not accounted for as a separate contract. A lease modification that results in a separate contract, including when the modification grants the lessee an additional right of use that is not included in the original lease, is accounted for in the same manner as a new lease. The Company monitors its material leases on a quarterly basis.

Operating lease liabilities and their correspondingright-of-use assets are recordedeach performance obligation based on the present value of lease payments over the expected remaining lease term. Certain adjustments to theright-of-use asset may be required for items suchrelative standalone selling price and recognizes as incentives received. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate, which reflects the fixed rate at which the Company could borrow on a collateralized basisrevenue the amount of the lease paymentstransaction price that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied.

Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in the same currency, for a similar term, in a similar economic environment. In transition to ASC 842,Company’s condensed consolidated balance sheets. If the Company utilized the remaining lease term of its leases in determining the appropriate incremental borrowing rates.

In accordance with ASC 842, components of a lease should be split into three categories: lease components (e.g., land, building, etc.),non-lease components (e.g., common area maintenance, consumables, etc.) andnon-components (e.g., property taxes, insurance, etc.). The fixed andin-substance fixed contract consideration, including any consideration related tonon-components, must be allocated based on the respective relative fair values to the lease components andnon-lease components.

Although separation of lease andnon-lease componentsperformance obligation is required, certain practical expedients are available. Entities may elect the practical expedient not to separate lease andnon-lease components. Rather, entities would account for each lease component and the relatednon-lease component together as a single component. For new and amended leases beginning in 2019 and after, the Company has elected to account for the lease andnon-lease components for leases for classes of all underlying assets together and allocate all of the contract consideration to the lease component only.

Investments

The Company determines the appropriate classification of its investments in debt securities at the time of purchase. All of the Company’s securities are classified asavailable-for-sale and are reported in short-term investments or long-term investments based on maturity dates and whether such assets are reasonably expected to be realizedsatisfied within the next twelve months this will be classified in cash or sold or consumed during the normal cycle of business.Available-for-sale investmentscurrent liabilities. Amounts recognized as revenue prior to receipt are recorded at fair value,as contract assets in the Company's balance sheets. If the Company expects to have an unconditional right to receive the consideration in the next twelve months, this will be classified in current assets. A net contract asset or liability is presented for each contract with unrealized gains or losses included in accumulated other comprehensive income (loss) on the Company’s Condensed Consolidated Balance Sheets, exclusive of other-than-temporary impairment losses, if any. Investments may be composed of corporate debt securities, commercial paper, U.S. government and agency securities and certificates of deposit.a customer.

Recently Adopted Accounting Pronouncements

In February 2016,On January 1, 2020, the Company adopted Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13No. 2016-02,, Measurement of Credit Losses on Financial Instruments “Leases (Topic 842),” which. This ASU requires that credit losses be reported using an entityexpected losses model rather than the incurred losses model that is currently used, and establishes additional disclosures related to recognize assets and liabilities arising from a lease for both financing and operating leases on their balance sheet date. ASUNo. 2016-02 is effective for fiscal years beginning after December 15, 2018. In July 2018, an amendment was made that allows companiescredit risks. For available-for-sale debt securities with unrealized losses, the optionstandard requires allowances to be recorded instead of usingreducing the effective dateamortized cost of the new standard as the initial application date (at the beginning of the period in which the new standard is adopted, rather than at the beginning of the earliest comparative period). This update includes a short-term lease exception for leases with a term of 12 months or less, in which a lessee can make an accounting policy election not to recognize the associated lease assets and lease liabilities on its balance sheet. Additionally, in March 2019, the FASB issued ASU2019-01,Leases (Topic 842): Codification Improvements (“ASUNo. 2019-01”). ASUNo. 2019-01 clarifies the transition guidance related to interim disclosures provided in the year of adoption. Lessees will continue to differentiate between finance leases (previously referred to as capital leases) and operating leases, using classification criteria that are substantially similar to the previous guidance. For lessees, the recognition, measurement, and presentation of expenses and cash flows arising from a lease did not significantly change from previous U.S. GAAP. The modified retrospective method includes several optional practical expedients that entities may elect to apply, as well as transition guidance specific to nonstandard leasing transactions. The Company adopted Topic 842 on January 1, 2019 using a cumulative-effect adjustment on the effective date of the standard, for which comparative periods are presented in accordance with the previous guidance under ASC 840.

In adopting Topic 842, the Company elected to utilize the available package of practical expedients permitted under the transition guidance within the new standard, which does not require the reassessment of the following: i) whether existing or expired arrangements are or contain a lease, ii) the lease classification of existing or expired leases, and iii) whether previous initial direct costs would qualify for capitalization under the new lease standard. Additionally, the Company made an accounting policy election to keep leases with a term of 12 months or less off its balance sheet.

Adoption of this standard resulted in the recording of $210 each of operating lease liabilities and aright-of-use asset on the Company’s condensed consolidated balance sheet on the effective date.investment. The adoption of thethis standard did not have a material effectimpact on the Company’s condensed consolidated financial statements of operations, comprehensive loss, cash flows or convertible preferred stock and stockholders’ equity (deficit). Refer to Note 10 forright-of-userelated disclosures. asset and liabilities recorded during the six months ended June 30, 2019.

Recently Issued Accounting Pronouncements

There have been no new accounting pronouncements or changes to accounting pronouncements during the sixthree months ended June 30, 2019,March 31, 2020, as compared to the recent accounting pronouncements described in Note 2 of the Company’s Annual Report on Form10-K for the year ended December 31, 2018,2019, which could be expected to materially impact the Company’s unaudited condensed consolidated financial statements.

3. FAIR VALUE MEASUREMENTS

The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values:

 

Description

  June 30, 2019   Quoted Prices in
Active Markets
for Identical
Assets (Level 1)
   Significant Other
Observable
Inputs
(Level 2)
   Significant Other
Observable
Inputs
(Level 3)
 

 

March 31, 2020

 

 

Quoted Prices in

Active Markets

for Identical

Assets (Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Other

Observable

Inputs

(Level 3)

 

Assets

        

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds and cash equivalents

  $25,119   $25,119   $—     $—   

U.S. Treasury securities

   38,200    38,200    —      —   
  

 

   

 

   

 

   

 

 

Money market funds and other cash equivalents

 

$

43,153

 

 

$

43,153

 

 

$

 

 

$

 

Total financial assets

  $63,319   $63,319   $—     $—   

 

$

43,153

 

 

$

43,153

 

 

$

 

 

$

 

  

 

   

 

   

 

   

 

 

Description

  December 31, 2018   Quoted Prices in
Active Markets
for Identical
Assets (Level 1)
   Significant Other
Observable
Inputs

(Level 2)
   Significant Other
Observable
Inputs

(Level 3)
 

Assets

        

Money market funds and cash equivalents

  $80,043   $80,043   $—     $—   
  

 

   

 

   

 

   

 

 

Total financial assets

  $80,043   $80,043   $—     $—   
  

 

   

 

   

 

   

 

 

Description

 

December 31,

2019

 

 

Quoted Prices in

Active Markets

for Identical

Assets (Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Other

Observable

Inputs

(Level 3)

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Overnight repurchase agreements

 

$

30,001

 

 

$

 

 

$

30,001

 

 

$

 

U.S. Treasury securities

 

 

17,540

 

 

 

17,540

 

 

 

 

 

 

 

Money market funds and other cash equivalents

 

 

1,093

 

 

 

1,093

 

 

 

 

 

 

 

Total financial assets

 

$

48,634

 

 

$

18,633

 

 

$

30,001

 

 

$

 

When developing fair value estimates, the Company maximizes the use of observable inputs and minimizes the use of unobservable inputs. When available, the Company uses quoted market prices to measure fair value. The Company classifies its money market funds and U.S. Treasury securities asvaluation technique used to measure fair value for the Company's Level 1 and Level 2 assets underis a market approach, using prices and other relevant information generated by market transactions involving identical or comparable assets. If market prices are not available, the fair value measurement is based on models that use primarily market-based parameters including yield curves, volatilities, credit ratings and currency rates. In certain cases where market rate assumptions are not available, the Company is required to make judgments about assumptions market participants would use to estimate the fair value of a financial instrument.

The Company did not have any transfers of assets between Level 1 and Level 2 of the fair value measurement hierarchy as these assets have been valued using quoted market prices in active markets without any valuation adjustment.during the three months ended March 31, 2020.

4. INVESTMENTS

The following table summarizesAs of March 31, 2020, the Company’sCompany did not hold any short-term or long-term investments.

As of December 31, 2019, the Company held available-for-sale investments which are consideredavailable-for-sale and were included in short-term investments on the condensed consolidated balance sheet as of June 30, 2019:and summarized in the table below:

 

   June 30, 2019 
   Cost Basis   Gross
Unrealized
Gains
   Gross
Unrealized
Losses
   Fair Value 

U.S. Treasury securities

  $38,164   $36   $—     $38,200 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $38,164   $36   $—     $38,200 
  

 

 

   

 

 

   

 

 

   

 

 

 

 

 

December 31, 2019

 

 

 

Cost Basis

 

 

Gross

Unrealized

Gains

 

 

Gross

Unrealized

Losses

 

 

Fair Value

 

U.S. Treasury securities

 

$

17,526

 

 

$

14

 

 

$

 

 

$

17,540

 

Total

 

$

17,526

 

 

$

14

 

 

$

 

 

$

17,540

 

Certain short-term debt securities with original maturities of less than 90 days are included in cash and cash equivalents on the condensed consolidated balance sheet and are not included in the table above. As of June 30,December 31, 2019, all investments havehad a contractual maturitiesmaturity within one year. The Company had no investments as of December 31, 2018.

5. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

Accrued expenses and other current liabilities at June 30, 2019March 31, 2020 and December 31, 20182019 consisted of the following:

 

  June 30,
2019
   December 31,
2018
 

 

March 31,

2020

 

 

December 31,

2019

 

Accrued compensation and benefits

  $552   $709 

 

$

551

 

 

$

1,155

 

Accrued professional services

   1,211    585 

 

 

959

 

 

 

1,004

 

Lease liabilities

   967    —   

 

 

199

 

 

 

504

 

Other

   232    223 

 

 

225

 

 

 

276

 

  

 

   

 

 

Total accrued expenses and other current liabilities

  $2,962   $1,517 

 

$

1,934

 

 

$

2,939

 

  

 

   

 

 

Accrued compensation and benefits consists primarily of accrued bonuses. Accrued professional services consists primarily of consulting services, legal services and services provided by contract research organizations (“CRO”) and contract manufacturing organizations (“CMO”).


6. CONVERTIBLE PREFERRED STOCK

Series A convertible preferred stock and Series B convertible preferred stock is collectively referred to as “Preferred Stock.”DEBT

On October 23, 2018, uponJuly 2, 2019 (the “Closing Date”), the closingCompany entered into a loan and security agreement (the “Loan Agreement”), for term loans with Oxford Finance LLC (“Oxford”) and Horizon Technology Finance Corporation (“Horizon,” and, together with Oxford, the “Lenders”). The Loan Agreement allows the Company to borrow up to $20,000 issuable in two equal tranches (the “Term Loans”). On the Closing Date, the first tranche of the Company’s IPO, all outstanding shares of Preferred Stock converted into 11,789,775 shares of the Company’s common stock. As such, there were no outstanding shares of Preferred Stock as of June 30, 2019 and December 31, 2018.

The rights and privileges of the preferred stockholders were as follows:

Conversion: Each share of Preferred Stock$10,000 was convertible, at the option of the holder, at any time, into shares of common stock on aone-for-1.90993 basis. The conversion ratio was determined by dividing the original issue price of $1.4933drawn down by the conversion priceCompany (the “Term A Loan”). The second tranche of $0.78186. The Preferred Stock would automatically convert into shares of common stock at the closing a Qualified IPO (as defined in the Company’s amended and restated certificate of incorporation, as amended from time to time) or in anon-Qualified IPO, upon the approval of at least 60% of the preferred stockholders.

Liquidation Preference: Prior$10,000 will be available to the IPO, in the event of any liquidation or “Deemed Liquidation Event,” defined below, the preferred stockholders would have been entitledCompany through September 30, 2020, subject to certain clinical milestones (the “Term B Loan”).

The outstanding loan balance will accrue interest at the greater of (i) the original issue pricerate of the Preferred Stockone-month U.S. LIBOR rate plus any accrued dividends not yet paid plus any other dividends declared6.25% and unpaid or (ii) 8.75%. The Loan Agreement provides for an interest only period until July 1, 2021, followed by thirty-six equal monthly payments of principal and interest continuing through June 1, 2024 (the “Maturity Date”). The Company has the amount payable had all classesoption to prepay the outstanding balance prior to maturity, subject to a prepayment fee of shares been converted1.0% to common stock. In3.0% depending upon when the eventprepayment occurs. Upon repayment of the Term Loans, the Company is required to make a Deemed Liquidation Event, accrued dividends would not exceed 40%final payment to the Lenders equal to 4.5% of the original issue price. After paymentsprincipal amount of all preferential amounts are madethe Term Loans funded which will be accrued by charges to interest expense over the term of the loans using the effective interest method.

In conjunction with the Loan Agreement, the Company issued 15,686 of common stock warrants (“Warrants”) to the preferred stockholders, any remaining assets wouldLenders at a per share exercise price of $12.75, a maximum contractual term of 10 years and exercisable immediately. The fair value of the Warrants was accounted for as a debt discount and calculated to be distributedapproximately $136 using the Black-Scholes method. The Company determined the Warrants met the criteria for equity classification, and, as such, the fair value of the Warrants is recorded as additional paid-in capital on the condensed consolidated balance sheets. Finally, the Company incurred issuance costs of approximately $150. Both the debt discount and issuance costs will be accreted to Notes payable by charges to interest expense over the term of the Term A Loan using the effective interest method.

The Loan Agreement contains customary representations, warranties and covenants and also includes customary events of default. Events of default include, among other things, the Company’s failure to pay amounts due, a breach of certain covenants, a material adverse change event, misrepresentations and judgments. Upon the occurrence of an event of default, a default interest rate of an additional 5.00% per annum may be applied to the common stockholders on a pro rata basis. A Deemed Liquidation Event was defined as a merger, consolidation, reorganization or similar transaction;outstanding loan balances, and the sale transfer, exclusive license ofLenders may declare all oroutstanding obligations immediately due and payable. Borrowings under the Loan Agreement are collateralized by substantially all the Company’s assets, other than its intellectual property, which include maintaining certain cash balances in controlled accounts.

Interest expense was $272 for the three months ended March 31, 2020. The effective rate on the Loan Agreement, including the amortization of the Company’s assets/intellectual property; or the sale or transfer of shares to any person (or group of related or affiliated persons), directly or indirectly, representing a greater than 50%debt discount and issuance costs, and accretion of the voting powerfinal payment, was 9.7% at March 31, 2020. The components of the voting securitieslong-term debt balance are as follows:

 

 

March 31,

2020

 

 

December 31,

2019

 

Notes payable, gross

 

$

10,000

 

 

$

10,000

 

Less: Unamortized debt discount and

   issuance costs

 

 

(235

)

 

 

(254

)

Accretion of final payment fee

 

 

97

 

 

 

64

 

Carrying value of notes payable

 

 

9,862

 

 

 

9,810

 

Less: Current portion of long-term debt

 

 

 

 

 

 

Long-term debt, net of issuance costs and

   discount

 

$

9,862

 

 

$

9,810

 

As of March 31, 2020, the Company.estimated future principal payments due were as follows:

Dividends:Preferred stockholders were entitled to receive, when and if declared by the board of directors (the “Board”) out of any funds legally available, dividends at the rate of 8% of the original issue price per share. No dividends were declared or paid through October 23, 2018, the date on which all of the Preferred Stock was converted to common stock upon the closing of the Company’s IPO.

 

 

As of

March 31,

2020

 

2020

 

 

 

2021

 

 

1,945

 

2022

 

 

3,333

 

2023

 

 

3,333

 

2024

 

 

1,389

 

Total principal payments

 

$

10,000

 

Voting Rights:Preferred Stock and common stock voted together as one class on an as converted basis.


7. STOCK-BASED COMPENSATION

Equity Incentive Plans

In December 2014, the Company adopted the LogicBio Therapeutics, Inc. 2014 Equity Incentive Plan, as amended (the “2014 Plan”), for the issuance of stock options and other stock-based awards. In October 2018, the Company’s 2018 Equity Incentive Plan (the “2018 Plan”) became effective and as a result, no further awards will be made under the 2014 Plan. The 2018 Plan was established to provide equity-based ownership opportunities for employees and directors, as well as outside consultants and advisors. The 2018 Plan authorized up to 1,183,214 of shares of the Company’s common stock to be issued. In addition, anyAny previously granted awards under the 2014 Plan will remain outstanding in accordance with their respective terms.

Under the 2018 Plan, there is an annual increase on January 1 of each year from 2019 until 2028, by the lesser of (i) 4% of the number of shares of common stock outstanding on December 31 of the prior year and (ii) an amount determined by the Board. On January 1, 2019,2020, the Company increased the number of shares available for future grant under the 2018 Plan by 887,535926,786 shares. At June 30, 2019,March 31, 2020, there were 1,288,2491,309,885 shares available for future grant under the 2018 Plan.

The 2018 Plan is administered by the Board. The exercise prices, vesting and other restrictions are determined at the discretion of the board of directors,Board, except that the exercise price per share of stock options may not be less than 100% of the fair market value of the common stock on the date of grant. Stock options awarded under the 2018 Plan expire 10 years after the grant date, unless the Board sets a shorter term. Vesting periods for awards under the 2018 Plan are determined at the discretion of the Board. Incentive stock options granted to employees and shares of restricted stock granted to employees, officers, members of the Board, advisors, and consultants of the Company typically vest over four years.Non-statutory options and shares of restricted stock granted to employees, officers, members of the Board, advisors, and consultants of the Company typically vest over three orone to four years.

Stock Options

During the sixthree months ended June 30,March 31, 2020 and 2019, and 2018, the Company granted options to purchase 174,591714,203 and 596,39479,123 shares of common stock, respectively, with a weighted-average grant date fair value per share of $6.34$4.74 and $4.20,$6.03, respectively. The Company recorded stock-based compensation expense for options granted of $674$761 and $85$210 during the sixthree months ended June 30,March 31, 2020 and 2019, and 2018, respectively. As of June 30, 2019,March 31, 2020, there were 2,509,5722,930,587 options outstanding and $5,215$7,268 of unrecognized stock-based compensation expense related to unvested stock options to be recognized over a weighted-average period of 3.1 years.

Restricted Common Stock

The Company has granted shares of restricted common stock with time-based and performance-based vesting conditions from time to time. During the sixthree months ended June 30,March 31, 2020 and 2019, the Company did not grant any shares of restricted common stock. During the six months ended June 30, 2018, the Company granted 107,054 shares of restricted common stock. The Company recorded stock-based compensation expense for restricted common stock granted of $133$44 and $148$66 during the sixthree months ended June 30,March 31, 2020 and 2019, and 2018, respectively. As of June 30, 2019,March 31, 2020, there were 564,02783,047 shares of unvested restricted common stock outstanding and $393$216 of unrecognized stock-based compensation expense related to unvested restricted common stock to be recognized over a weighted-average period of 2.11.8 years.

Stock-Based Compensation Expense

Total stock-based compensation expense recorded as research and development and general and administrative expenses, respectively, for employees, directors andnon-employees for the sixthree months ended June 30,March 31, 2020 and 2019 and 2018 is as follows:

 

  Six Months Ended
June 30,
 

 

Three Months Ended

March 31,

 

      2019           2018     

 

2020

 

 

2019

 

Research and development

  $352   $96 

 

$

295

 

 

$

155

 

General and administrative

   455    137 

 

 

510

 

 

 

121

 

  

 

   

 

 

Total stock-based compensation expense

  $807   $233 

 

$

805

 

 

$

276

 

  

 

   

 

 

8. STOCKHOLDERS’ EQUITY

Open Market Sale Agreement

On November 15, 2019, the Company entered into an Open Market Sale Agreement (the “Open Market Sale Agreement”) with Jefferies LLC, as agent (“Jefferies”), pursuant to which the Company may issue and sell shares of its common stock having an


aggregate offering price of up to $50,000 (the “Open Market Shares”) from time to time through Jefferies (the “Open Market Offering”).

Under the Open Market Sale Agreement, Jefferies may sell the Open Market Shares by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Exchange Act of 1934, as amended. The Company may sell the Open Market Shares in amounts and at times to be determined by the Company from time to time subject to the terms and conditions of the Open Market Sale Agreement, but it has no obligation to sell any of the Open Market Shares in the Open Market Offering.

The Company or Jefferies may suspend or terminate the offering of Open Market Shares upon notice to the other party and subject to other conditions. The Company has agreed to pay Jefferies commissions for its services in acting as agent in the sale of the Open Market Shares in the amount of up to 3.0% of gross proceeds from the sale of the Open Market Shares pursuant to the Open Market Sale Agreement. The Company has also agreed to provide Jefferies with customary indemnification and contribution rights.

The Company did not issue any shares under the Open Market Sales Agreement during the quarter ended March 31, 2020. From April 1 through May 7, 2020, the Company issued 51,889 shares of its common stock at an average weighted price of $5.76 per share, resulting in gross proceeds to the Company of $299. Costs associated with the proceeds consist of a 3% cash commission.

9. REVENUE

In January 2020, the Company entered into a research agreement with Takeda for the development of product candidate LB-301 to treat Crigler-Najjar Syndrome. Under the terms of the Takeda Agreement, Takeda will fund all research and development activities related to the development of LB-301 under a pre-agreed upon research plan (the “Research Plan”). The Takeda Agreement also provides Takeda with an exclusive, non-binding option to enter into a license agreement to the LB-301 program upon the exercise of an option (the “License Option”).

The Company assessed the Takeda Agreement in accordance with ASC 606 and concluded that that it represents a contract with a customer and is within the scope of ASC 606. The promised goods and services represent one combined performance obligation and the entire transaction price will be allocated to that single combined performance obligation. In addition, the Company concluded that the License Option does not provide any discounts or other rights. Terms related to an exclusive license negotiated after the exercise of the License Option will be part of a separate contract and reflect applicable standalone selling prices. As such, the Company concluded the License Option is not considered to be a material right.

Under the Takeda Agreement, Takeda is obligated to reimburse the Company for the costs incurred under the Research Plan. Costs incurred are billed by the Company to Takeda from time to time. The Company elected to recognize revenue under the "right to invoice" practical expedient based on the Company's right to invoice Takeda at an amount that approximates the value to the customer and the performance completed to date. For the quarter ended March 31, 2020, the Company recognized $1,021 as service revenue under the Takeda Agreement. Further, as of March 31, 2020, the Company recorded $1,065 as deferred revenue within current liabilities on the Company’s condensed consolidated balance sheets related to the Takeda Agreement.


10. INCOME TAXES

For the sixthree months ended June 30, 2019March 31, 2020 and the year ended December 31, 2018,2019, the Company maintained a full valuation allowance on federal and state deferred tax assets since management does not forecast the Company to be in a profitable position in the near future. The income tax provision within the condensed consolidated statements of operations for the three months ended March 31, 2019 related to tax expense of the wholly owned foreign subsidiary, LogicBio Therapeutics Research Ltd.

Ltd, which ceased operations in 2018 and was formally dissolved in November 2019.

9.11. LOSS PER SHARE

Basic loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average shares of common sharesstock outstanding, without consideration to common stock equivalents:

 

  Three Months Ended June 30,   Six Months Ended June 30, 

 

Three Months Ended March 31,

 

  2019   2018   2019   2018 

 

2020

 

 

2019

 

Numerator:

        

 

 

 

 

 

 

 

 

Net loss

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

 

$

(9,455

)

 

$

(7,697

)

Less: accruals of dividends of Preferred Stock

   —      (4,630   —      (4,630
  

 

   

 

   

 

   

 

 

Net loss attributable to common stockholders — basic and diluted

  $(10,048  $(8,217  $(17,745  $(10,521
  

 

   

 

   

 

   

 

 

Denominator:

        

 

 

 

 

 

 

 

 

Weighted-average common stock outstanding

   22,479,511    1,962,570    22,396,780    1,875,440 

 

 

23,175,802

 

 

 

22,313,129

 

  

 

   

 

   

 

   

 

 

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

  $(0.45  $(4.19  $(0.79  $(5.61
  

 

   

 

   

 

   

 

 

Net loss per share — basic and diluted

 

$

(0.41

)

 

$

(0.34

)

The Company’s potentially dilutive shares, which include any outstanding Preferred Stock and stock options, as well aswarrants and unvested restricted stock, are considered to be common stock equivalents and are only included in the calculation of diluted net loss when their effect is dilutive. The common stock equivalent computation for Preferred Stock uses the applicable conversion rate then in effect for any outstanding shares of Preferred Stock.

The Company excluded the following potential common stock equivalents from the computation of diluted net loss per share attributable to common stockholders because including them would have had an anti-dilutive effect for the three and six months ended June 30, 2019March 31, 2020 and 2018:2019.

 

 

March 31,

2020

 

 

March 31,

2019

 

  June 30,
2019
   June 30,
2018
 

Preferred Stock

   —      11,789,775 

Unvested restricted stock

   564,027    1,205,378 

 

 

83,047

 

 

 

724,383

 

Options to purchase common stock

   2,509,572    2,043,251 

 

 

2,930,587

 

 

 

2,429,562

 

Term A Loan warrants

 

 

15,686

 

 

 

 

10.

12. LEASES

The Company has historically entered into lease arrangements for its facilities and certain equipment. As of June 30, 2019,March 31, 2020, the Company had threeone operating leaseslease with required future minimum payments. In applying the transition guidance under ASC Topic 842Leases (“ASC 842”), the Company determined the classification of these leasesthis lease to be an operating leaseslease and recorded aright-of-use asset and lease liabilitiesliability as of the effective date. The Company’s leases generally do not include termination or purchase options. From time to time, leases may include options to renew the lease after the expiration of the initial lease term. A renewal period is included in the lease term only when it reasonably certain that the Company will exercise such renewal options. As of June 30, 2019,March 31, 2020, no renewal options existed that the Company felt were reasonably certain of being exercised.


Operating Leases

In December 2018, the Company entered into an operating lease for laboratory and office space in Cambridge, Massachusetts for a14-month term, ending in March 2020. As required under the terms of the lease agreement as collateral for the facility lease, the Company had restricted cash of $146 in the form of a certificate deposit as of June 30, 2019 and December 31, 2018.

The following table contains a summary of the lease costs recognized under TopicASC 842 and other information pertaining to the Company’s operating leases for the three and six months ended June 30, 2019March 31, 2020 and as of June 30, 2019:

 

 

Three Months Ended

March 31, 2020

 

 

Three Months

Ended

March 31, 2019

 

Operating leases  Three Months Ended
June 30, 2019
   Six Months Ended
June 30, 2019
 

 

 

 

 

 

 

 

 

Lease cost

    

 

 

 

 

 

 

 

 

Operating lease cost

  $315   $589 

 

$

325

 

 

$

274

 

Variable lease cost

   92    134 

 

 

98

 

 

 

42

 

  

 

   

 

 

Total lease cost

  $407   $723 

 

$

423

 

 

$

316

 

  

 

   

 

 

Other year-to-date lease information

    

 

 

 

 

 

 

 

 

Operating cash flows used for operating leases

    $521 

 

$

321

 

 

$

199

 

Operating lease liabilities arising from obtaining right-of-use assets

    $1,323 

 

$

 

 

$

1,323

 

Other operating lease information      As of June 30, 2019 

Operating lease liabilities — short term

    $967 

Operating lease liabilities — long term

    $—   

Weighted average remaining lease term

     0.8 years 

Weighted average discount rate

     7.04

The following table contains a summary of the lease liabilities recognized on the Company’s condensed consolidated balance sheets as of March 31, 2020 and December 31, 2019:

 

 

As of March 31, 2020

 

 

As of December 31, 2019

 

Other operating lease information

 

 

 

 

 

 

 

 

Operating lease liabilities — short term

 

$

199

 

 

$

504

 

Operating lease liabilities — long term

 

$

 

 

$

 

Weighted average remaining lease term

 

0.6 years

 

 

0.7 years

 

Weighted average discount rate

 

 

7.04

%

 

 

7.04

%

The variable lease costs for the three and six months ended June 30, 2019March 31, 2020 include common area maintenance and other operating charges. As the Company’s leases do not provide an implicit rate, the Company utilized its incremental borrowing rate based on what it would normally pay to borrow on a collateralized basis over a similar term for an amount equal to the lease payments at the commencement date in determining the present value of lease payments. As of June 30, 2019,March 31, 2020, the Company classified its short-term operating lease liabilities within accrued expenses and other current liabilities.

Future minimum lease payments under the Company’s operating leases as of June 30, 2019March 31, 2020 and December 31, 2018,2019, were as follows:

 

 

As of

March 31, 2020

 

 

As of

December 31, 2019

 

Maturity of lease liabilities  As of
June 30, 2019
   As of
December 31, 2018
 

 

 

 

 

 

 

 

 

2019

  $624   $1,028 

2020

   377    223 

 

$

204

 

 

$

523

 

Thereafter

   —      —   

 

 

 

 

 

 

  

 

   

 

 

Total lease payments

  $1,001   $1,251 

 

$

204

 

 

$

523

 

Less: imputed interest

   (34  

 

 

(5

)

 

 

(19

)

  

 

   

Total operating lease liabilities at June 30, 2019

  $967   
  

 

   

Total operating lease liabilities

 

$

199

 

 

$

504

 

11.

In November 2019, the Company entered into a lease agreement for office, laboratory and vivarium space located at 65 Hayden Avenue Lexington, Massachusetts (“65 Hayden Ave Lease”) to replace the Company’s prior headquarters located at 99 Erie Street Cambridge, Massachusetts. Under the terms of the 65 Hayden Ave Lease, the Company will lease approximately 23,901 square feet of space and pay an initial annual base rent of approximately $1,494, which is subject to scheduled annual increases, plus certain operating expenses and taxes. The Company took possession of the space on April 1, 2020 (“Lease Commencement Date”) and the lease will continue through July 1, 2025 (“Lease Termination Date”). The Company has an option to extend the lease for a single additional term of 5 years. Upon execution of the 65 Hayden Ave Lease, the Company executed a $622 cash-collateralized letter of credit. Lease payments are anticipated to begin three months after the Lease Commencement Date and will continue in monthly installments through the Lease Termination Date.


The Company will assess the lease classification of the 65 Hayden Ave Lease and commence recognition of the associated rent expense as of the Lease Commencement Date.

13. RELATED PARTIES

From time to time, the Company is or has been party to consulting service agreements with each of its three founders.co-founders. Under the terms of each agreement, the Company pays an annual fee of $68 for research and development consulting services. For each of the three months ended June 30, 2019 and 2018,March 31, 2020, the Company charged $34recorded research and development expense of $17 related to consulting services received from Mark Kay, who is one of the co-founders and a member of the Board. For the three months ended March 31, 2019, the Company recorded $51 to research and development expenses under these consulting service agreements. For the six months ended June 30, 2019 and 2018, the Company charged $84 and $68 to research and development expenses, respectively, under these consulting service agreements. In addition, beginning in 2018, each founder receives $5 annually for their participation on the Scientific Advisory Board. Each founder has also received stock options for their services as either a board member or member of the Scientific Advisory Board.

In March 2017, the Company subleased to an affiliate certain space in Tel Aviv, Israel, through June 2018. For theagreements with its three and six months ended June 30, 2018, the Company recognized income of $8 and $21, respectively, in other income related to this arrangement.co-founders.


12. SUBSEQUENT EVENTS

On July 2, 2019 (the “Closing Date”), the Company entered into a loan and security agreement (the “Loan Agreement”), for term loans with Oxford Finance LLC (“Oxford”) and Horizon Technology Finance Corporation (“Horizon”, together with Oxford, the “Lenders”). The Loan Agreement allows the Company to borrow up to $20,000 issuable in two equal tranches (the “Term Loans”). On the Closing Date, the first tranche of $10,000 was drawn down by the Company (the “Term A Loan”). The second tranche of $10,000 will be available to the Company through September 30, 2020 and is subject to certain funding conditions (the “Term B Loan”).

The outstanding loan balance will accrue interest at the greater of (i) the rate of theone-month U.S. LIBOR rate plus 6.25% and (ii) 8.75%. The Loan Agreement provides for an interest only period until July 1, 2021, followed bythirty-six equal monthly payments of principal and interest continuing through June 1, 2024 (the “Maturity Date”). Upon repayment of the Term Loans, the Company is required to make a final payment to the Lenders equal to 4.5% of the original principal amount of the Term Loans funded which will be accrued by charges to interest expense over the term of the loans using the effective-interest method. In conjunction with the Loan Agreement, the Company incurred issuance costs of approximately $150.

In connection with the borrowing under the Term A Loan, the Company issued warrants to the Lenders. Due to a clerical error, the warrants were initially issued to purchase an aggregate of 31,372 shares of the Company’s common stock. The Company subsequently amended the warrants to provide for the correct number of 15,686 underlying shares of common stock with an exercise price of $12.75. The warrants are immediately exercisable and have a maximum contractual term of 10 years. The Company will determine the aggregate fair value of the warrants issued which will be recorded as a debt discount and accreted to interest expense over the life of the Term A Loan.

The Loan Agreement contains customary representations, warranties and covenants and also includes customary events of default. Events of default include, among other things, the Company’s failure to pay amounts due, a breach of certain covenants, a material adverse change event, misrepresentations and judgements. Upon the occurrence of an event of default, a default interest rate of an additional 5.00% per annum may be applied to the outstanding loan balances, and the Lenders may declare all outstanding obligations immediately due and payable. Borrowings under the Loan Agreement are collateralized by substantially all the Company’s assets, other than its intellectual property.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial informationstatements and the accompanying notes thereto included in this Quarterly Report on Form10-Q and the audited consolidated financial information and the notes thereto included in our Annual Report on Form10-K for the year ended December 31, 2018,2019, which was filed with the Securities and Exchange Commission, or SEC, on April 1, 2019.March 16, 2020.

This discussion contains certain forward-looking statements that involve risks and uncertainties. Forward-looking statements are identified by words such as “believe,” “will,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “could,” “potentially” or the negative of these terms or similar expressions. You should read these statements carefully because they discuss future expectations, contain projections of future results of operations or financial condition, or state other “forward-looking” information. These statements relate to our future plans, objectives, expectations, intentions and financial performance and the assumptions that underlie these statements. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed in the “Risk Factors” section of our Annual Report on Form 10-K and in this Quarterly Report on Form10-Q. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. These statements, like all statements in this Quarterly Report on Form10-Q, speak only as of their date, and except as required by law, we undertake no obligation to update or revise these statements in light of future developments. We caution investors that our business and financial performance are subject to substantial risks and uncertainties.

Overview

We are a genome editing company focused on developing medicines to durably treat rare diseases in pediatric patients with significant unmet medical need using GeneRide, our proprietary technology platform. Our GeneRide technology is designed to precisely integrate corrective genes into a patient’s genome to provide a stable therapeutic effect. Because GeneRide is designed to have this durable therapeutic effect, we are initially targeting rare liver disorders in pediatric patients where it is critical to provide treatment early in a patient’s life before irreversible disease pathology can occur. We have demonstrated proof of concept of our therapeutic platform in animal models for a number of diseases and are focusing on development of our lead product candidate,LB-001, for the treatment of Methylmalonic Acidemia, or MMA, a life-threatening disease that presents at birth.

Based on our GeneRide technology, we are developing our lead product candidate,LB-001, to treat MMA. We planIn January 2020, we announced the submission of an investigational new drug application, or IND, to advanceLB-001 to an IND filing insupport the fourth quarterinitiation of 2019 and into a Phase 1/2 clinical trial in pediatric patients with MMA, patientswhich the FDA has 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 first halfstudies 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 2020. the Phase 1/2 clinical trial for LB-001.

We believe that achieving clinical proof of concept in an inherited liver disease such as MMA will validate our platform technology, including its potential application to other organs and diseases. In January 2020, we announced a research agreement with Takeda Pharmaceutical Company Limited, or Takeda, to further develop LB-301 in Crigler-Najjar syndrome, or CN, the second indication to be pursued using the GeneRide platform. In addition to MMA and CN, we have demonstrated proof of concept of our platform in hemophilia B and alpha-1-antitrypsin deficiency, or A1ATD, and Crigler-Najjar syndrome animal disease models. We plan to nominate a second indication by the end of 2019. We expect to select future product candidates from these genetic diseases or others addressed by targeting the liver initially, and later by targeting the central nervous system, or CNS, and muscle.

Since our inception in 2014, we have devoted the majority of our efforts to business planning, research and development, developing and protecting our intellectual property, raising capital and recruiting management and technical staff. We do not have any products approved for sale and have not generated any revenue.our only revenue has consisted of service revenue related to research cost reimbursement received under the Takeda agreement. As of June 30, 2019,March 31, 2020, we have raised approximately $9.8 million in net proceeds through the loan and security agreement in July 2019, approximately $72.3 million in net proceeds through our initial public offering, or IPO, in October 2018 and approximately $33.1 million in net proceeds from the sale of our convertible preferred stock in 2016 and 2017. We have incurred significant operating losses since our inception. Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and commercialization of our product candidate and any future product candidates. Our net loss was $10.0 million and $17.7$9.5 million for the three and six months ended June 30, 2019, respectively,March 31, 2020 and our accumulated deficit was $45.0$76.8 million as of June 30, 2019.March 31, 2020. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future in connection with our ongoing activities. Furthermore,


Impact of COVID-19

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

Since mid-March 2020, our non-laboratory employees have been working remotely in order 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, or CDC. Our laboratory employees, whose work must be performed on premises, have been working in shifts to continue our in-house research and manufacturing activities on a decreased basis. We have also ceased all business travel for our employees. We plan to maintain these or similar restrictions on our business activities until we expectbelieve our employees can fully resume such business activities in accordance with federal, state and local requirements and guidelines.

Our research, development and manufacturing activities are dependent on our ability to incur additional costs associatedcontinue our work on premises at our laboratory. We also rely on third parties located in countries that are affected by the COVID-19 pandemic, including the United States, for certain research, development and manufacturing activities. Similar to how we have restricted business activities at our premises, many of these third parties have also limited their staff from working on premises as part of their response to COVID-19. While we believe we and our third party vendors, suppliers and collaborators have largely been able to continue essential business activities to a certain degree, we cannot predict the impact of the progression of the COVID-19 pandemic on future results due to a variety of factors, including the health of our and their employees, our ability to maintain operations, the ability of our third party vendors, suppliers and collaborators to continue operations, any further government and/or public actions taken in response to the pandemic and ultimately the length of the pandemic.

In April 2020, as part of our effort to preserve capital, our leadership team volunteered to accept salary cuts ranging from 15% to 20%. We have also adopted certain other cost-cutting measures aimed at enhancing our capital position. During April and through May 7, 2020, we entered into “at-the-market” sales of our common stock resulting in gross proceeds of approximately $0.3 million. While we intend to continue to evaluate ways to enhance our liquidity and capital position, our efforts will largely depend on future developments that are highly uncertain and cannot be predicted with operating as a public company that we did not previously incur or had previously incurredconfidence at lower rates as a private company, including significant legal, accounting, investor relationsthis time.

We plan to continue to closely monitor the COVID-19 pandemic in order to ensure the safety of our personnel and other expenses.to continue advancing our research and development activities.

Components of Results of Operations

Revenue

Since inception through June 30, 2019, we haveTo date, the Company’s only revenue has consisted of research cost reimbursements recognized as service revenue, all of which is attributable to the Company’s January 2020 research agreement with Takeda to develop LB-301 in CN. The Company has not generated any revenue. We dorevenue from product sales and does not expect to generate any revenue from the sale of products in the near future. If our development efforts forLB-001, or other product candidates that we may develop in the future, are successful and result in regulatory approval or collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from collaboration or license agreements.

for the foreseeable future.

Operating Expenses

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts and the development of our product candidates, and include:

salaries, benefits and other related costs, including stock-based compensation expense, for personnel engaged in research and development functions;

license maintenance fees and milestone fees incurred in connection with various license agreements;

the costcosts of laboratory supplies and acquiring, developing and manufacturing preclinical study and, eventually, clinical trial materials;

expenses incurred under agreements with contract research organizations, or CROs, contract manufacturing organizations, or CMOs, as well as academic institutions and consultants that conduct our preclinical studies and other scientific development services;

facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs;

costs of outside consultants, including their fees, stock-based compensation and related travel expenses; and


 

costs of outside consultants, including their fees, stock-based compensation and related travel expenses; and

costs related to compliance with regulatory requirements.

We expense research and development costs as incurred. Costs for external development activities are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors.tasks. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our financial statements as prepaid or accrued research and development expenses.

Research and development activities are central to our business model. We expect that our research and development expenses will continue to increase for the foreseeable future as we plan and initiate clinical trials for our product candidateLB-001 and continue to discover and develop additional product candidates. If any of our product candidates enter into later stages of clinical development, they will generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in our executive, finance, corporate and business development and administrative functions. General and administrative expenses also include professional fees for legal, patent, accounting, auditing, tax and consulting services, travel expenses, and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.

We expect that our general and administrative expenses will increase in the future as we increase our general and administrative headcount to support our continued research and development and potential commercialization of our product candidates. We also expect to continue to incur increased expenses associated with being a public company, including costs of accounting, audit, legal, regulatory and tax compliance services, director and officer insurance costs, and investor and public relations costs.

Other Income (Expense), Net

Interest income net consists primarily of interest on our cash and cash equivalents and investments. Interest expense consists of interest expense related to the aggregate $10.0 million principal amount of the Term A Loan borrowing under the loan and security agreement in July 2019. A portion of the interest expense on the Term A Loan is non-cash expense relating to the accretion of the debt discount and amortization of issuance costs. In the three months ended March 31, 2020, we recorded $0.3 million in interest expense, of which $0.2 million relates to cash interest paid and the remainder to the accretion of the debt discount and amortization of issuance costs. Other expense, net consists primarily of foreign exchange losses.

Results of Operations

Comparison of the Three Months Ended June 30,March 31, 2020 and 2019 and 2018

The following table summarizes our results of operations for the three months ended June 30, 2019March 31, 2020 and 2018:2019:

 

 

Three Months Ended

March 31,

 

  Three Months Ended
June 30,
 

 

2020

 

 

2019

 

  2019   2018 

 

(in thousands)

 

  (in thousands) 

Operating expenses:

    

REVENUE

 

 

 

 

 

 

 

 

Service revenue

 

$

1,021

 

 

$

 

Total revenue

 

 

1,021

 

 

 

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

Research and development

  $7,934   $2,226 

 

 

7,173

 

 

 

5,486

 

General and administrative

   2,524    1,416 

 

 

3,192

 

 

 

2,632

 

  

 

   

 

 

Total operating expenses

   10,458    3,642 

 

 

10,365

 

 

 

8,118

 

  

 

   

 

 

Loss from operations

   (10,458   (3,642

 

 

(9,344

)

 

 

(8,118

)

  

 

   

 

 

Other income:

    

Other income, net

   410    53 
  

 

   

 

 

Other income (expense):

 

 

 

 

 

 

 

 

Other (expense) income, net

 

 

(111

)

 

 

443

 

Loss before income taxes

   (10,048   (3,589

 

 

(9,455

)

 

 

(7,675

)

Income tax benefit

   —      2 
  

 

   

 

 

Income tax provision

 

 

 

 

 

(22

)

Net loss

  $(10,048  $(3,587

 

$

(9,455

)

 

$

(7,697

)

  

 

   

 

 


Revenue

The Company’s revenue for the three months ended March 31, 2020 consisted solely of the $1.0 million in research cost reimbursements recognized as service revenue under the January 2020 research agreement with Takeda.

Research and Development Expenses

The following table summarizes our research and development expenses for the three months ended June 30, 2019March 31, 2020 and 2018:2019:

 

  Three Months Ended
June 30,
     

 

Three Months Ended

March 31,

 

 

 

 

 

  2019   2018   Increase 

 

2020

 

 

2019

 

 

Increase

 

  (in thousands) 

 

(in thousands)

 

LB-001 external development and manufacturing costs

  $4,676   $793   $3,883 

 

$

3,494

 

 

$

2,754

 

 

$

740

 

Personnel-related costs

   1,498    482    1,016 

 

 

1,766

 

 

 

1,197

 

 

 

569

 

Other research and development costs

   1,760    951    809 

 

 

1,913

 

 

 

1,535

 

 

 

378

 

  

 

   

 

   

 

 

Total research and development expenses

  $7,934   $2,226   $5,708 

 

$

7,173

 

 

$

5,486

 

 

$

1,687

 

  

 

   

 

   

 

 

Research and development expenses for the three months ended June 30, 2019March 31, 2020 were $7.9$7.2 million, compared to $2.2$5.5 million for the three months ended June 30, 2018.March 31, 2019. The increase of approximately $5.7$1.7 million was primarily due to an increaseincreases of approximately $3.9$0.7 million related to external development and manufacturing expenses for our lead product candidate,LB-001, $0.8 $0.4 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 our lead product candidateLB-001 and $1.0$0.6 million in personnel-related costs relateddue to an increase in headcount. Personnel-related costs for the three months ended June 30, 2019March 31, 2020 included stock-based compensation expense of $0.2$0.3 million, compared to $48,000$0.2 million for the three months ended June 30, 2018.March 31, 2019. While there may be fluctuations on a quarterly basis, we expect that our research and development costs will decrease over the next twelve months as we believe that we have already incurred a significant proportion of the LB-001 external development and manufacturing costs needed to bring LB-001 into clinical development.

General and Administrative Expenses

General and administrative expenses were $2.5$3.2 million for the three months ended June 30, 2019,March 31, 2020, compared to $1.4$2.6 million for the three months ended June 30, 2018.March 31, 2019. The increase of approximately $1.1$0.6 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 the 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.

Other Income, Net

Other income, net was $0.4 million for the three months ended June 30, 2019, compared to other income, net of $0.1 million for the three months ended June 30, 2018. The change was primarily related to the increase in interest income from cash equivalents and investments.

Comparison of the Six Months Ended June 30, 2019 and 2018

The following table summarizes our results of operations for the six months ended June 30, 2019 and 2018:

   Six Months Ended
June 30,
 
   2019   2018 
   (in thousands) 

Operating expenses:

    

Research and development

  $13,420   $3,681 

General and administrative

   5,156    2,334 
  

 

 

   

 

 

 

Total operating expenses

   18,576    6,015 
  

 

 

   

 

 

 

Loss from operations

   (18,576   (6,015
  

 

 

   

 

 

 

Other income:

    

Other income, net

   853    124 
  

 

 

   

 

 

 

Loss before income taxes

   (17,723   (5,891

Income tax provision

   (22   —   
  

 

 

   

 

 

 

Net loss

  $(17,745  $(5,891
  

 

 

   

 

 

 

Research and Development Expenses

The following table summarizes our research and development expenses for the six months ended June 30, 2019 and 2018:

   Six Months Ended
June 30,
     
   2019   2018   Increase 
   (in thousands) 

LB-001 external development and manufacturing costs

  $7,430   $1,287   $6,143 

Personnel-related costs

   2,695    994    1,701 

Other research and development costs

   3,295    1,400    1,895 
  

 

 

   

 

 

   

 

 

 

Total research and development expenses

  $13,420   $3,681   $9,739 
  

 

 

   

 

 

   

 

 

 

Research and development expenses for the six months ended June 30, 2019 were $13.4 million, compared to $3.7 million for the six months ended June 30, 2018. The increase of approximately $9.7 million was primarily due to an increase of approximately $6.1 million related to external development and manufacturing expenses for our lead product candidateLB-001, $1.9 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 our lead product candidateLB-001 and $1.7 million in personnel-related costs related to an increase in headcount. Personnel-related costs for the six months ended June 30, 2019 included stock-based compensation expense of $0.4 million, compared to $0.1 million for the six months ended June 30, 2018.

General and Administrative Expenses

General and administrative expenses were $5.2 million for the six months ended June 30, 2019, compared to $2.3 million for the six months ended June 30, 2018. The increase of approximately $2.9 million was primarily due to professional fees and personnel-related costs, includingwhich include salaries, stock-based compensation and bonuses. Thebonus. This increase in professional fees was primarily due to the increase in legal, auditing and consulting services provided. The increase in personnel-related costs was primarily due to an increase in headcount, ofincluding at the executive level, employees.as well as an increase in stock-based compensation expense. Stock-based compensation expense included in general and administrative expenses was $0.5 million and $0.1 million for the sixthree months ended June 30,March 31, 2020 and 2019, respectively. We expect that our general and 2018, respectively.

Other Income, Netadministrative expenses will remain relatively consistent over the next twelve months, although there may be fluctuations on a quarterly basis.

Other income,(Expense) Income, Net

Other expense, net was $0.9$0.1 million for the sixthree months ended June 30, 2019,March 31, 2020, compared to other income, net of $0.1$0.4 million for the sixthree months ended June 30, 2018.March 31, 2019. The changenet decrease was primarily related to the increasea decrease in interest income from cash equivalentsdue to lower interest rates and investments.lower capital resource balances as well as interest expense related to the loan and security agreement.

Liquidity and Capital Resources

Overview

Since our inception and through June 30, 2019,March 31, 2020, we have not generated any sales revenue and have incurred significant losses and negative cash flows from our operations.

As a result of the uncertainties for our business caused by the COVID-19 pandemic, we have implemented certain measures as part of our effort to preserve capital as described further under the heading “Impact of COVID-19.” As of March 31, 2020, we had cash and cash equivalents of $43.2 million, which we believe will be able to fund our operating expenses and capital expenditure requirements through the second quarter of 2021. While we intend to continue to evaluate ways to enhance our liquidity and capital position, our efforts will largely depend on future developments that are highly uncertain and cannot be predicted with confidence at this time. As such, there is substantial doubt about the Company’s ability to continue as a going concern within one year of the date these financial statements are filed.


Cash Flows

The following table summarizes our cash flows for the sixthree months ended June 30, 2019March 31, 2020 and 2018:2019:

 

   Six Months Ended
June 30,
 
   2019   2018 
   (in thousands) 

Net cash used in operating activities

  $(16,962  $(6,316

Net cash used in investing activities

   (38,577   (15

Net cash provided by financing activities

   82    —   

Effect of foreign exchange rates on cash and cash equivalents

   7    17 
  

 

 

   

 

 

 

Net decrease in cash and cash equivalents

  $(55,450  $(6,314
  

 

 

   

 

 

 

 

 

Three Months Ended

March 31,

 

 

 

2020

 

 

2019

 

 

 

(in thousands)

 

Net cash used in operating activities

 

$

(7,538

)

 

$

(8,232

)

Net cash provided by (used in) investing activities

 

 

17,500

 

 

 

(44,809

)

Net cash provided by financing activities

 

 

84

 

 

 

 

Effect of foreign exchange rates on cash and cash

   equivalents

 

 

 

 

 

5

 

Net increase (decrease) in cash, cash equivalents and restricted cash

 

$

10,046

 

 

$

(53,036

)

Operating Activities

During the sixthree months ended June 30, 2019,March 31, 2020, net cash used in operating activities increasedwas approximately $10.6$7.5 million, primarily related to an increase in our net loss adjusted fornon-cash charges and changes in the components of working capital. The increase$0.7 million decrease in net cash used in operating activities during the sixthree months ended June 30, 2019March 31, 2020 as compared to the sixthree months ended June 30, 2018,March 31, 2019, was primarily driven by an increase in our net loss duedeferred revenue related to an increase in both ourthe January 2020 research and development and general and administrative expenses.agreement with Takeda.

Investing Activities

During the sixthree months ended June 30,March 31, 2020, net cash provided by investing activities was $17.5 million as the proceeds from our short-term investments that matured during the period were not reinvested and were instead held as cash and cash equivalents. During the three months ended March 31, 2019, net cash used in investing activities increased approximately $38.6was $44.8 million which primarily related to netoutflows of our cash and cash equivalents into short-term investments activity of $37.8 million and a $0.7 million increase in the purchases of property and equipment as compared to the six months ended June 30, 2018.investments.

Financing Activities

During the sixthree months ended June 30, 2019,March 31, 2020, net cash provided by financing activities consisted of approximatelywas $0.1 million related to the exercise of stock options. During the sixthree months ended June 30, 2018,March 31, 2019, there were no net cash inflows or outflows related to financing activities.

Funding Requirements

We expect ourto continue to incur a significant amount of expenses to increase substantially in connection with our ongoing activities particularly asfor the foreseeable future. In particular, we advancewill incur significant expenses related to the preclinical activities and clinical trials of our product candidatecandidates and any future product candidates.

We expect that our expenses will increase substantially if and as we:

continue our current research programs and our preclinical development of any product candidates from our current or future research programs;

initiate clinical trials forLB-001 and any other product candidates we identify and develop;

seek to identify, assess, acquire and/or develop additional research programs and additional product candidates;

seek marketing approvals for any product candidate that successfully complete clinical trials;

develop, optimize, scale and validate a manufacturing process and analytical methods for any product candidates we may develop;

establish and build out internal process and analytical development capabilities and researchpreclinical and preclinicalclinical grade production;

obtain market acceptance of any product candidates we may develop as viable treatment options;


 

obtain market acceptance of any product candidates we may develop as viable treatment options;

address competing technological and market developments;

maintain, expand and protect our intellectual property portfolio and provide reimbursement of third-party expenses related to our patent portfolio;

further develop our GeneRide technology platform;

hire additional technical, quality, regulatory, clinical, scientific and commercial personnel and add operational, financial and management information systems and personnel, including personnel to support our process and product development, manufacturing and planned future commercialization efforts;

make royalty, milestone or other payments under current and any futurein-license agreements;

establish and maintain supply chain and manufacturing relationships with third parties that can provide adequate products and services, in both amount, timing and quality, to support clinical development and the market demand for any product candidate for which we obtain regulatory and marketing approval;

leasinglease and buildingbuild new facilities, including offices and labs, to support organizational growth;

validate andbuild-out a commercial-scale current Good Manufacturing Practices, or cGMP, manufacturing facility; and

establish a sales, marketing and distribution infrastructure to commercialize any product candidates for which we may obtain marketing approval.

BecauseWe are unable to estimate the timing and amounts of increased capital outlays and operating expenses associated with completing the research and development of our product candidates because of the numerous risks and uncertainties associated with the development ofLB-001 and any other product candidates and programs we may develop and because the extent to which we may enter into collaborations with third parties for development ofLB-001 and any other product candidates we may develop is unknown,unknown. For example, in January 2020, we are unableannounced the submission of an IND to estimatesupport the timinginitiation of a Phase 1/2 clinical trial in pediatric patients with MMA, which the FDA has placed on clinical hold pending the resolution of certain clinical and amounts of increased capital outlays and operating expenses associated with completing the research and development of our product candidates.nonclinical questions. Our future funding requirements, both near and long-term, will depend on many factors, including:

 

the initiation, scope, progress, timing, costs and results of drug discovery, preclinical development, laboratory testing, and planned clinical trials forLB-001 and any other product candidates;

the outcome, timing and cost of meeting regulatory requirements established by the U.S. Food and Drug Administration, or FDA, and other comparable foreign regulatory authorities, including resolving any potential clinical holds that may be imposed on us;

the impact of the COVID-19 pandemic on our ability to progress with our research, development, manufacturing and regulatory efforts, including our plans to resolve the clinical hold placed by the FDA on the IND for LB-001;

the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;

the cost of defending potential intellectual property disputes, including patent infringement actions;

the achievement of milestones or occurrence of other developments that trigger payments under any of our current agreements or other agreements we may enter into;

the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial and other research and development costs under future collaboration agreements, if any;

the effect of competing technological and market developments;

the cost and timing of completion of clinical or commercial-scale manufacturing activities;

the extent to which wein-license or acquire other products and technologies;

our ability to establish and maintain collaborations on favorable terms, if at all;

the cost of establishing sales, marketing and distribution capabilities forLB-001 and any other product candidates in regions where we choose to commercialize our product candidates, if approved; and

the initiation, progress, timing and results of our commercialization ofLB-001 and any other product candidates, if approved, for commercial sale.


A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the research and development of that product candidate. For example, if the clinical hold on the IND for LB-001 causes significant delays in the progress of our MMA program, the FDA or another

regulatory authority were to require us to conduct preclinical studies or clinical trials beyond those that we anticipate will be required, for the completion of clinical development of a product candidate, or if we experience significant trial delays due to patient enrollment or other reasons, we would be required to expend significant additional financial resources and time on preclinical and clinical research and development activities. Any significant delays in our programs may also require us to reevaluate our corporate strategy, resulting in the completionexpenditure of clinical development.significant resources and time. We may never succeed in obtaining regulatory approval for our product candidatecandidates or any future product candidates.

Until such time, if ever, that we can generate product revenue sufficient to achieve profitability, we expect to finance our cash needs through offerings of securities, private equity financing, debt financings, collaborations, government contracts or other strategic transactions. The terms of financing may adversely affect the holdings or the rights of our stockholders. If we are unable to obtain funding, we may be required to delay, limit, reduce or terminate some or all of our research and product development, product portfolio expansion or future commercialization efforts.

We will also continueAt-the-Market Sales of Common Stock

In November 2019, we entered into an open market sale agreement with Jefferies LLC as the sales agent. Under the terms of this sale agreement, we may sell shares of our common stock, from time to incur costs as a public company that wetime, having an aggregate value of up to $50 million through Jefferies LLC. We did not previously incur or have previously incurred at lower rates, including increased fees payable toissue any shares under thenon-employee members sales agreement during the quarter ended March 31, 2020. From April 1 through May 7, 2020, we issued 51,889 shares of our boardcommon stock at an average weighted price of directors, increased personnel costs, increased director$5.76 per share, resulting in gross proceeds to us of $0.3 million. Costs associated with the proceeds consist of a 3% cash commission.

Contractual Obligations and officer insurance premiums, audit and legal fees, investor relations fees and expenses for compliance with publicCommitments

We are a smaller reporting company, reporting requirementsas defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, or the Exchange Act,for this reporting period and rules implemented by the SEC and Nasdaq.

Contractual Obligations and Commitments

Our principalare not required to provide additional information on our contractual obligations consistand commitments pursuant to Item 303 of our operating lease agreements as well as service and research agreements with collaborators, CROs, CMOs and other third parties for preclinical research studies and testing, all of which are entered in the normal course of business.

As of June 30, 2019, there have been no significant changes to our futurenon-cancelable minimum payments under service and research agreements from those reported in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” included in our Annual Report on Form10-K for the year ended December 31, 2018, filed with the SEC on April 1, 2019, other than normalperiod-to-period variations.

We may incur potential contingent payments upon our achievement of clinical, regulatory or commercial milestones, as applicable, or royalty payments under license agreements we have entered with research institutions, including Stanford University, the University of Texas and the National Institutes of Health. The timing and likelihood of these contingent payments are not currently known and would be difficult to predict or estimate due to the uncertainty of the achievement and timing of the events requiring payments under these agreements.Regulation S-K.

Policies and Significant Judgments and Estimates

Our condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of our condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

There have been no significant changes to our critical accounting policies from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” included in our Annual Report on Form10-K for the year ended December 31, 2018,2019, filed with the SEC on April 1, 2019.March 16, 2020, other than the significant accounting policy over revenue recognition under ASC 606, which is described further in Note 2 to the financial statements included in this Quarterly Report on Form 10-Q.

Emerging Growth Company Status

The Jumpstart Our Business Startups Act of 2012 permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have irrevocably elected to “opt out” of this provision and, as a result, we will comply with new or revised accounting standards when they are required to be adopted by public companies that are not emerging growth companies.

Off-Balance Sheet Arrangements

We have not entered into anyoff-balance sheet arrangements and do not have any holdings in variable interest entities.


Recently Issued Accounting Pronouncements

Refer to Note 2 in the accompanying notes to our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report onForm 10-Q for a discussion of recent accounting pronouncements.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

We are exposed to market risksa smaller reporting company, as defined in Rule 12b-2 under the ordinary courseSecurities Exchange Act of our business. These risks primarily include interest rate sensitivities and foreign currency exchange rate sensitivities.

Interest Rate Sensitivity

As of June 30, 2019, we had cash, cash equivalents and investments of $63.7 million. Our exposure to interest rate sensitivity is impacted by changes in the underlying U.S. bank interest rates. From time to time, our surplus cash has been invested in interest-bearing savings accounts and U.S. government and agency securities. We have not entered into investments1934, as amended, for trading or speculative purposes. Due to the conservative nature of our investment portfolio, which is predicated on capital preservation of investments with short-term maturities, we do not believe an immediate one percentage point change in interest rates would have a material effect on the fair market value of our portfolio, and therefore we do not expect our operating results or cash flows to be significantly affected by changes in market interest rates.

As of June 30, 2019, we had no debt outstandingthis reporting period and are therefore not subjectrequired to interest rate risk related to debt.

Foreign Currency Exchange Risk

The functional currency of our wholly owned foreign subsidiary, LogicBio Therapeutics Research Ltd, or LogicBio Research, isprovide the Israeli new shekel. Assets and liabilities of LogicBio Research are translated into United States dollars at the exchange rate in effect on the consolidated balance sheet date. Income items and expenses are translated at the average exchange rate in effect during the period. Stockholders’ equity (deficit) amounts are translated based on historical exchange rates as of the date of each transaction. Unrealized translation gains and losses are recorded as a foreign currency translation adjustment, which is included in the Condensed Consolidated Statements of Convertible Preferred Stock and Stockholder’s Equity (Deficit)as a component of accumulated other comprehensive loss. Adjustments that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in other expense, net in the Condensed Consolidated Statements of Operations as incurred. All operations ceased for LogicBio Research as of September 30, 2018.information required under this item.

We do not currently engage in currency hedging activities in order to reduce our currency exposure, but we may begin to do so in the future. Instruments that may be used to hedge future risks include foreign currency forward and swap contracts. These instruments may be used to selectively manage risks, but there can be no assurance that we will be fully protected against material foreign currency fluctuations.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures.Procedures

Our management, with the participation of our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer), evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2020. The term “disclosure controls and procedures,” as defined in Rules13a-15(e) and15d-15(e) under the Securities Exchange Act of 1934, as of June 30, 2019. Our disclosureamended (the “Exchange Act”), means controls and other procedures of a company that are designed to ensure that information we are required to disclosebe disclosed by a company in the reports we filethat it files or submitsubmits under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosures, and is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms.

Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on thatthe evaluation our Chief Executive Officer and Chief Financial Officer concluded thatof our disclosure controls and procedures as of June 30, 2019 were not effective due to the material weakness identified in fiscal year 2017 inMarch 31, 2020, our internal control over financial reporting process which included an ineffective control environment, including a lackChief Executive Officer and our Chief Financial Officer concluded that, as of sufficient accounting personnel and personnel with financial reporting expertise, ineffective controls procedures, including those related to recognition in the appropriate period for certain transactions, ineffective risk assessment controls, including those policies and practices that would identify changes insuch date, our business practices, which could significantly impact our consolidated financial statements and system of internaldisclosure controls and ineffective monitoring of controls related toprocedures were effective at the financial close and reporting process.

Remediation Plan

We are committed and are taking steps necessary to remediate the control deficiencies that constituted the above material weakness by implementing changes to our internal control over financial reporting. During 2018 and through June 30, 2019, we made the following enhancements to our control environment including the following:

We added finance personnel to the organization to strengthen our internal accounting team to include a controller and a senior director of external reporting and technical accounting.

We engaged a third party to help us enhance our documentation of accounting policies and positions on technical accounting topics throughout the year.

With the support of outside consultants, we completed risk assessment activities, which include evaluating and documenting the design of our internal controls that address the relevant risks, and identifying any gaps in the internal control environment that require remediation.

We engaged outside consultants to assist us in the evaluation of our information systems to determine if there are internal control gaps that should be addressed in the general information technology controls and implement any needed improvements for existing systems.

Our remediation activities are continuing through the remainder of 2019. In addition to the above activities, we expect to engage in additional activities in the current year, including:

Continue to engage external consultants to provide support related to more complex applications of GAAP and document and assess our accounting policies and procedures;

Implement or refine internal controls that remediate gaps identified during the design assessment; and

Engage outside consultants to perform tests of our system of internal controls to monitor the operating effectiveness of operation of our internal controls and to gainreasonable assurance whether such controls are present and functioning.level.

We continue to redesign and implement internal control activities. We continue to establish policies and procedures and enhance corporate oversight over process-level controls and structures to ensure that there is appropriate assignment of authority, responsibility, and accountability to enable remediating our material weakness.

We believe that our remediation plan will be sufficient to remediate the identified material weakness and strengthen our internal control over financial reporting. As we continue to evaluate, and work to improve, our internal control over financial reporting, management may determine that additional measures to address control deficiencies or modifications to the remediation plan are necessary. We cannot assure you, however, when we will remediate such weaknesses, nor can it be certain whether additional actions will be required or the costs of any such actions. Moreover, we cannot assure you that additional material weaknesses will not arise in the future.

Changes in Internal Control overOver Financial Reporting.Reporting

Except for the remediation efforts of the previously identified material weakness as described above, thereThere were no changes in our internal control over financial reporting that occurred during the three monthsquarter ended June 30, 2019March 31, 2020 that have materially affected, or wereare reasonably likely to materially affect, our internal control over financial reporting.

As a result of the COVID-19 pandemic, certain employees began working remotely in March. Notwithstanding these changes to the working environment, we have not identified any material changes in our internal control over financial reporting. We are continually monitoring and assessing the COVID-19 situation to determine any potential impact on the design and operating effectiveness of our internal controls over financial reporting.


PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

From time to time, we may become involved in legal proceedings and claims arisingOn March 18, 2020, a purported shareholder class action, John R. Afinowicz v. LogicBio Therapeutics, Inc., et al.,was filed in the ordinary courseUnited States District Court for the District of New Jersey, naming us and certain of our business. Although the resultsofficers as defendants. The lawsuit alleges that we made material misrepresentations and/or omissions of litigationmaterial fact relating to our Investigational New Drug submission for LB-001 in our public disclosures, in violation of Sections 10(b) and claims cannot be predicted with certainty, as20(a) of the endSecurities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder. The complaint seeks certification of a class of purchasers of our common stock during the period from December 3, 2018 through February 10, 2020. The plaintiff seeks unspecified monetary damages on behalf of the period covered byputative class and an award of costs and expenses, including attorney’s fees. We believe that this Quarterly Report on Form10-Q, we did not believe we were partyaction is without merit and intend to any claimdefend it vigorously. At this time, no assessment can be made as to the likely outcome of this lawsuit or litigation,whether the outcome of which, if determined adverselywill be material to us, would individually or in the aggregate be reasonably expected to have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.us.

Item 1A. Risk Factors.

In addition to the other information set forth in this report, you should carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019, which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K may not be the only risks facing the Company. Additional risks and uncertainties not currently known to the Company or that the Company currently deems to be immaterial also may materially adversely affect the Company’s business, financial condition and/or operating results.

There have been no material changes from the risk factors previously disclosed in the Company’s Annual Report on Form10-K for the fiscal year ended December 31, 2018,2019, filed with the SEC on April 1, 2019,March 16, 2020, except as set forthnoted below.

The termsOur business has been adversely affected by the ongoing coronavirus pandemic and we expect it to continue to have a negative impact on our business.

In December 2019, a novel strain of coronavirus, referred to as 2019-ncov, COVID-19 coronavirus epidemic, or COVID-19, was reported to have surfaced in Wuhan, China. COVID-19 has since become a global pandemic and has had a significant negative effect on business activities across the world.  

Since mid-March 2020, our Loannon-laboratory employees have been working remotely in order to comply with social distancing and Security Agreement place“stay at home” orders as well as applicable guidelines from the U.S. Centers for Disease Control and Prevention, or CDC. Our laboratory employees, whose work must be performed on premises, have been working in shifts to continue our in-house research and manufacturing activities on a decreased basis. We have also ceased all business travel for our employees. We plan to maintain these or similar restrictions on our operatingbusiness activities until we believe our employees can fully resume such business activities in accordance with federal, state and financial flexibility.

In July 2019, we entered into a Loanlocal requirements and Security Agreement with Oxford Finance LLC and Horizon Technology Finance Corporation (the “Loan Agreement”), which is secured by substantially all of our assets other than our intellectual property, which is subject to a negative pledge. We borrowed $10.0 million upon execution of the Loan Agreement under an initial term A loan. Oxford Finance LLC and Horizon Technology Finance Corporation will make an additional term B loan in an aggregate principal amount up to $10.0 million upon the occurrence of the Milestone Event (as defined in the Loan Agreement).

The Loan Agreement contains representations and warranties, affirmative and negative covenants applicable to usguidelines. Our productivity and our subsidiariesability to meet our timelines and eventsgoals may be negatively affected if our business activities continue to be subjected to these restrictions.

Our research, development and manufacturing activities are dependent on our ability to continue our work on premises at our laboratory. We also rely on third parties, such as CROs and CMOs, located in areas that are affected by the COVID-19 pandemic for certain research, development and manufacturing activities. Similar to how we have restricted business activities at our premises, many of default, in each case subject to grace periods, thresholds and materiality qualifiers,these third parties have also limited their staff from working on premises as more fully described in the Loan Agreement. The affirmative covenants include, among others, covenants requiring us and our subsidiaries to maintain our legal existence and material governmental approvals, deliver certain financial reports, maintain insurance coverage and maintain certain cash balances in controlled accounts. The negative covenants include, among others, restrictions on dispositions, changes in business, management, ownership or business locations, mergers or acquisitions, indebtedness, encumbrances, maintenancepart of collateral accounts, distributions, investments, transactions with affiliates and subordinated debt.

The Loan Agreement also includes events of default, the occurrence and continuation of which provide Oxford Finance LLC, as collateral agent, with the right to exercise remedies against us and the collateral securing the loans under the Loan Agreement, including foreclosure against our properties securing the Loan Agreement, including our cash, potentially requiring us to renegotiate our agreement on terms less favorable to us or to immediately cease operations. These events of default include, among other things, the nonpayment of principal or interest, violations of covenants, material adverse changes, attachment, levy, restraint on business, cross-defaults on material indebtedness, bankruptcy, material judgments, misrepresentations, subordinated debt, governmental approvals, lien priority and delisting.

Further, if we are liquidated, the lenders’ right to repayment would be seniortheir response to the rights of the holders of our common stock to receive any proceeds from the liquidation.COVID-19 pandemic. The lenders could declareCOVID-19 pandemic may have a default upon the occurrence of any event that they interpret as a material adverse change as defined under the Loan Agreement, thereby requiring us to repay the loan immediately or to attempt to reverse the declaration of default through negotiation or litigation. Any declaration by the lenders of an event of default could significantly harmsignificant negative effect on our business and prospects and could causefuture results due to a variety of factors, including the pricehealth of our common stockemployees, our ability to decline.maintain operations, the ability of our third party vendors, suppliers and collaborators to continue operations, any further government and/or public actions taken in response to the pandemic and ultimately the length of the pandemic. This could lead to supply and other business interruptions with our third-party vendors, suppliers and collaborators, resulting in business/operational disruption which could have a material effect on our business.

Infections and deaths related to COVID-19 have significantly disrupted the United States’ healthcare and healthcare regulatory systems. Such disruptions have diverted healthcare resources away from regular activities at a number of institutions where clinical trials are normally conducted. Depending on the duration and severity of the pandemic, our efforts to engage with potential trial sites in start-up and other activities for our planned clinical trials or other studies may be adversely affected. In addition, other known and unknown factors caused by COVID-19 could materially delay other aspects of our clinical trials, including our ability to recruit and retain patients and principal investigators and site staff. Regulatory agencies such as the FDA, which must lift our clinical hold on the IND for LB-001 in MMA prior to the initiation of our interventional clinical trials, may also be disrupted by the pandemic, causing a delay in our plans. Any elongation or de-prioritization of our clinical trials or delay in regulatory review resulting from such disruptions could materially affect the development and study of our product candidates.


Our activities will continue to require a significant expenditure of capital resources. While the full extent of the economic impact brought by and the duration of the COVID-19 pandemic may be difficult to assess or predict, it has resulted in significant disruptions of global financial markets, reducing our ability to access capital. An extended period of disruption in the economy and capital markets could significantly affect our ability to raise additional capital on a timely basis, which would significantly disrupt our programs and also require us to reevaluate our corporate strategy.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Use of Proceeds from Initial Public Offering

On October 23, 2018, we closed our IPO, in which we issued and sold 8,050,000 shares of our common stock, including 1,050,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $10.00 per share for gross proceeds of $80.5 million, before deducting underwriting discounts and commissions and offering expenses payable by us. All of the shares issued and sold in the IPO were registered under the Securities Act pursuant to a Registration Statement on FormS-1 (FileNo. 333-227523), which was declared effective by the SEC on October 18, 2018. Jefferies LLC, Barclays Capital Inc. and William Blair & Company, L.L.C. acted as joint book-running managers of the offering and as representatives of the underwriters. Chardan Capital Markets, LLC acted as the lead manager for the offering. The offering commenced on October 18, 2018 and did not terminate until the sale of all of the shares offered.

The net offering proceeds to us, after deducting underwriting discounts and offering costs payable by us of an aggregate of approximately $8.2 million, were approximately $72.3 million. No material offering expenses were paid directly or indirectly to any of our directors or officers (or their associates) or persons owning 10.0% or more of any class of our equity securities or to any other affiliates.

There has been no material change in our planned use of the net offering proceeds from our IPO as described in our final prospectus filed with the SEC pursuant to Rule 424(b)(4) on October 18,22, 2018. We have been using and plan to continue to use the net proceeds from the IPO primarily to fund the development ofLB-001 in MMA and for discovery and preclinical development of additional product candidates, and for working capital and general corporate purposes.


Item 6. Exhibits.Exhibits.

 

EXHIBIT 3.1

Fourth Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Current Report onForm 8-K, File No. 001-38707, filed on October 29, 2018).

EXHIBIT 3.2

Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to the Company’s Current Report onForm 8-K, File No. 001-38707, filed on October 29, 2018).

EXHIBIT 10.1#10.1

Amendment No. 2 to the Amended and Restated Exclusive (Equity)Executive Employment Agreement, dated as of June 24, 2019,by and between the Company and The Board of Trustees of the Leland Stanford University.

EXHIBIT 10.2LogicBio Therapeutics, Inc. 2018 Equity Incentive Plan (incorporated by reference to Exhibit 10.8 to the Company’sForm S-1/A, File No. 333-227523, filed on October 9, 2018).and Kenneth Huttner.

EXHIBIT 10.3LogicBio Therapeutics, Inc. 2018 Employee Stock Purchase Plan (incorporated by reference to Exhibit  10.9 to the Company’s FormS-1/A, File No. 333-227523, filed on October 9, 2018).

EXHIBIT 31.1

Rule 13a—14(a) / 15d—14(a) Certifications — Chief Executive Officer.

EXHIBIT 31.2

Rule 13a—14(a) / 15d—14(a) Certifications — Chief Financial Officer.

EXHIBIT 32.1

Section 1350 Certifications.

EXHIBIT 101.INS

XBRL Instance Document.

EXHIBIT 101.SCH

XBRL Taxonomy Extension Schema Document.

EXHIBIT 101.CAL

XBRL Taxonomy Extension Calculation Linkbase Document.

EXHIBIT 101.DEF

XBRL Taxonomy Extension Definition Linkbase Document.

EXHIBIT 101.LAB

XBRL Taxonomy Extension Label Linkbase Document.

EXHIBIT 101.PRE    

—    

XBRL Taxonomy Extension Presentation Linkbase Document.

#

Certain confidential portions of this exhibit were omitted by means of marking such portions with asterisks because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.


SIGNATURESSIGNATURES

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 thereunto duly authorized.

 

LogicBio Therapeutics, Inc.

Dated: August 13, 2019May 11, 2020

By:

/s/ Frederic Chereau

Frederic Chereau

President and Chief Executive Officer

Dated: August 13, 2019May 11, 2020

By:

/s/ Matthias Jaffé

Matthias Jaffé

Chief Financial Officer

 

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