Table of Contents
UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM
10-Q

Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the quarterly period ended SeptemberJune 30, 2017

2021
Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the transition period from
to

Commission File
No. 001-31791

GALECTIN THERAPEUTICS INC.

Nevada
 
04-3562325

(State or other jurisdiction

of

incorporation)

 

(I.R.S. Employer

Identification No.)

4960 Peachtree Industrial Blvd.,
Suite 240,

Norcross, GA

 
30071
(Address of Principal Executive Offices)
 
(Zip Code)

(678)620-3186

620
-3186
(Registrant’s Telephone Number, Including Area Code)

Securities registered or to be 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
GALT
The Nasdaq Stock 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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation
S-T (§232.05
(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    ☒  Yes     ☐  No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated
filer, or 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
Rule 12b-2
of the Exchange Act.

Large Accelerated Filer   Accelerated Filer 
Non-Accelerated
Filer
 ☐ (Do not check if a smaller reporting company)  Smaller reporting 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 Rule
12b-2
of the Exchange Act).    ☐  Yes     ☒  No

The number of shares outstanding of the registrant’s common stock as of November 3, 2017August 10, 2021 was 35,638,698.

59,275,031.


Table of Contents
GALECTIN THERAPEUTICS INC.

INDEX TO FORM
10-Q

FOR THE QUARTER ENDED SEPTEMBERJUNE 30, 2017

2021
      
PAGE
 
  PART I — FINANCIAL INFORMATION  

ITEM 1.

  

Unaudited Condensed Consolidated Financial Statements

(unaudited)
  

Condensed Consolidated Balance Sheets as of SeptemberJune 30, 20172021 and December 31, 2016 (unaudited)2020

   3 

Condensed Consolidated Statements of Operations for the Three and NineSix Months Ended SeptemberJune 30, 20172021 and 2016 (unaudited)2020

   4 

Condensed Consolidated Statements of Cash Flows for the NineSix Months Ended SeptemberJune 30, 20172021 and 2016 (unaudited)2020

   5 

Notes to Unaudited Condensed Consolidated Financial Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the Three and Six Months Ended June 30, 2021 and 2020

   6 

ITEM 2.

  

Notes to Unaudited Condensed Consolidated Financial Statements

9
ITEM 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations

   1215 

ITEM 3.

  

Quantitative and Qualitative Disclosures about Market Risk

   2123 

ITEM 4.

  

Controls and Procedures

   2123 
  PART II — OTHER INFORMATION  

ITEM 1.

  

Legal Proceedings

   2124 

ITEM 1A.

  

Risk Factors

   2124 

ITEM 2.

  

Unregistered Sales of Equity Securities and Use of Proceeds

   2124 

ITEM 3.

  

Defaults Upon Senior Securities

   2124 

ITEM 4.

  

Mine Safety Disclosures

   2224 

ITEM 5.

  

Other Information

   2224 

ITEM 6.

  

Exhibits

   2224 

   2326 


Table of Contents
GALECTIN THERAPEUTICS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

   September 30,
2017
  December 31,
2016
 
   (in thousands) 

ASSETS

   

Current assets:

   

Cash and cash equivalents

  $6,958  $15,362 

Prepaid expenses and other current assets

   53   432 
  

 

 

  

 

 

 

Total current assets

   7,011   15,794 
  

 

 

  

 

 

 

Intangible assets, net

   —     1 
  

 

 

  

 

 

 

Total assets

  $7,011  $15,795 
  

 

 

  

 

 

 

LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY

   

Current liabilities:

   

Accounts payable

  $166  $910 

Accrued expenses

   4,175   2,802 

Accrued dividends payable

   —     68 
  

 

 

  

 

 

 

Total current liabilities

   4,341   3,780 
  

 

 

  

 

 

 

Total liabilities

   4,341   3,780 
  

 

 

  

 

 

 

Commitments and contingencies (Note 8)

   

Series C super dividend convertible preferred stock; 1,000 shares authorized, 176 shares issued and outstanding at September 30, 2017 and December 31, 2016, redemption value: $7,130,000, liquidation value: $1,760,000 at September 30, 2017

   1,723   1,723 

Stockholders’ equity:

   

Undesignated stock, $0.01 par value; 20,000,000 shares authorized, 20,000,000 and 14,001,000 designated at September 30, 2017 and December 31, 2016, respectively

   —     —   

Series A 12% convertible preferred stock; 1,742,500 shares authorized, 1,377,500 issued and outstanding at September 30, 2017 and December 31, 2016, liquidation value $1,377,500 at September 30, 2017

   557   557 

SeriesB-1 12% convertible preferred stock; 900,000 shares authorized, issued and outstanding at September 30, 2017 and December 31, 2016, liquidation value $1,800,000 at September 30, 2017

   1,761   1,761 

SeriesB-2 12% convertible preferred stock; 2,100,000 shares authorized, issued and outstanding at September 30, 2017 and December 31, 2016, liquidation value $4,200,000 at September 30, 2017

   3,697   3,697 

SeriesB-3 8% convertible preferred stock; 2,508,000 shares authorized, 2,508,000 issued and outstanding at September 30, 2017 and December 31, 2016, liquidation value $2,508,000 at September 30, 2017

   1,224   1,224 

Common stock, $0.001 par value; 50,000,000 shares authorized at September 30, 2017 and December 31, 2016, 35,638,698 and 32,912,942 issued and outstanding at September 30, 2017 and December 31, 2016, respectively

   36   33 

Additionalpaid-in capital

   172,053   166,721 

Retained deficit

   (178,381  (163,701
  

 

 

  

 

 

 

Total stockholders’ equity

   947   10,292 
  

 

 

  

 

 

 

Total liabilities, redeemable convertible preferred stock and stockholders’ equity

  $7,011  $15,795 
  

 

 

  

 

 

 

   
June 30,
2021
  
December 31,
2020
 
   
(in thousands)
 
ASSETS
         
Current assets:
         
Cash and cash equivalents
  $31,598  $27,142 
Prepaid expenses and other current assets
   1,736   2,323 
   
 
 
  
 
 
 
Total current assets
   33,334   29,465 
   
 
 
  
 
 
 
Other assets
   71   135 
   
 
 
  
 
 
 
Total assets
  $33,405  $29,600 
   
 
 
  
 
 
 
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
         
Current liabilities:
         
Accounts payable
  $924  $1,292 
Accrued expenses and other
   5,065   4,042 
Accrued dividends payable
   65   65 
   
 
 
  
 
 
 
Total current liabilities
   6,054   5,399 
   
 
 
  
 
 
 
Convertible note payable and accrued interest, net of debt discount – related party (Note 4)
   9,643   0   
Derivative liability (Note 4)
   592   0   
Other liabilities
   0     8 
   
 
 
  
 
 
 
Total liabilities
   16,289   5,407 
   
 
 
  
 
 
 
Commitments and contingencies (Note 10)
       
Series C super dividend redeemable convertible preferred stock; 1,000 shares authorized, 176 shares issued and outstanding at June 30, 2021 and December 31, 2020, redemption value: $8,494,000, liquidation value: $1,760,000 at June 30, 2021
   1,723   1,723 
Stockholders’ equity:
         
Undesignated stock, $0.01 par value; 20,000,000 shares authorized, 20,000,000 designated at June 30, 2021 and December 31, 2020, respectively
   0—     0—   
Series A 12% convertible preferred stock; 1,742,500 shares authorized, 1,302,500 issued and outstanding at June 30, 2021 and December 31, 2020, liquidation value $1,302,500 at June 30, 2021
   527   527 
Common stock, $0.001 par value; 100,000,000 shares authorized at June 30, 2021 and December 31, 2020, 59,275,031 and 57,077,055 issued and outstanding at June 30, 2021 and December 31, 2020, respectively
   59   56 
Additional
paid-in
capital
   269,657   261,883 
Retained deficit
   (254,850  (239,996
   
 
 
  
 
 
 
Total stockholders’ equity
   15,393   22,470 
   
 
 
  
 
 
 
Total liabilities, redeemable convertible preferred stock and stockholders’ equity
  $33,405  $29,600 
   
 
 
  
 
 
 
See notes to unaudited condensed consolidated financial statements.

3

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GALECTIN THERAPEUTICS INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

   Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
   2017  2016  2017  2016 
   (in thousands, except
per share data)
  (in thousands, except
per share data)
 

Operating expenses:

     

Research and development

  $3,503  $3,289  $10,719  $11,892 

General and administrative

   911   1,248   3,155   4,990 
  

 

 

  

 

 

  

 

 

  

 

 

 

Total operating expenses

   4,414   4,537   13,874   16,882 
  

 

 

  

 

 

  

 

 

  

 

 

 

Total operating loss

   (4,414  (4,537  (13,874  (16,882
  

 

 

  

 

 

  

 

 

  

 

 

 

Other income (expense):

     

Interest income

   6   11   21   37 
  

 

 

  

 

 

  

 

 

  

 

 

 

Total other income (expense)

   6   11   21   37 
  

 

 

  

 

 

  

 

 

  

 

 

 

Net loss

  $(4,408 $(4,526 $(13,853 $(16,845
  

 

 

  

 

 

  

 

 

  

 

 

 

Preferred stock dividends

   (254  (63  (827  (466

Preferred stock accretion

   —     (56  —     (173
  

 

 

  

 

 

  

 

 

  

 

 

 

Net loss applicable to common stockholders

  $(4,662 $(4,645 $(14,680 $(17,484
  

 

 

  

 

 

  

 

 

  

 

 

 

Net loss per common share — basic and diluted

  $(0.13 $(0.16 $(0.42 $(0.60

Weighted average common shares outstanding — basic
and diluted

   35,165   29,282   34,600   29,045 

   
Three Months Ended
June 30,
  
Six Months Ended
June 30,
 
   
2021
  
2020
  
2021
  
2020
 
   
(in thousands, except per share data)
  
(in thousands, except per share data)
 
Operating expenses:
                 
Research and development
  $6,450  $4,681  $11,349  $6,825 
General and administrative
   1,743   1,421   3,161   2,861 
   
 
 
  
 
 
  
 
 
  
 
 
 
Total operating expenses
   8,193   6,102   14,510   9,686 
   
 
 
  
 
 
  
 
 
  
 
 
 
Total operating loss
   (8,193  (6,102  (14,510  (9,686
   
 
 
  
 
 
  
 
 
  
 
 
 
Other income (expense):
                 
Interest income
   1   9   2   59 
Interest expense
   (85  (21  (107  (43
Change in fair value of derivative
   (172  0     (172  0   
   
 
 
  
 
 
  
 
 
  
 
 
 
Total other income (expense)
   (256  (12  (277  16 
   
 
 
  
 
 
  
 
 
  
 
 
 
Net loss
  $(8,449 $(6,114 $(14,787 $(9,670
   
 
 
  
 
 
  
 
 
  
 
 
 
Preferred stock dividends
   (65  (66  (67  (60
   
 
 
  
 
 
  
 
 
  
 
 
 
Net loss applicable to common stockholders
  $(8,514 $(6,180 $(14,854 $(9,730
   
 
 
  
 
 
  
 
 
  
 
 
 
Net loss per common share — basic and diluted
  $(0.15 $(0.11 $(0.26 $(0.17
Weighted average common shares outstanding — basic and diluted
   58,312   57,035   57,725   56,995 
See notes to unaudited condensed consolidated financial statements.

4

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GALECTIN THERAPEUTICS INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

   Nine Months Ended
September 30,
 
   2017  2016 
   (in thousands) 

CASH FLOWS FROM OPERATING ACTIVITIES:

   

Net loss

  $(13,853 $(16,845

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

   

Depreciation and amortization

   1   5 

Stock-based compensation expense

   829   2,001 

Issuance of common stock for services

   27   —   

Changes in operating assets and liabilities:

   

Prepaid expenses and other assets

   379   501 

Accounts payable and accrued expenses

   629   2,794 
  

 

 

  

 

 

 

Net cash used in operating activities

   (11,988  (11,544
  

 

 

  

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

   

Net proceeds from issuance of SeriesB-3 preferred stock and warrants

   —     1,500 

Net proceeds from issuance of common stock and warrants

   3,584   257 
  

 

 

  

 

 

 

Net cash provided by financing activities

   3,584   1,757 
  

 

 

  

 

 

 

NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS

   (8,404  (9,787

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

   15,362   25,846 
  

 

 

  

 

 

 

CASH AND CASH EQUIVALENTS, END OF PERIOD

  $6,958  $16,059 
  

 

 

  

 

 

 

NONCASH FINANCING ACTIVITIES:

   

Payment of preferred stock dividends in common stock

  $894  $534 

   
Six Months Ended
June 30,
 
   
2021
  
2020
 
   
(in thousands)
 
CASH FLOWS FROM OPERATING ACTIVITIES:
         
Net loss
  $(14,787 $(9,670
Adjustments to reconcile net loss to net cash flows from operating activities:
         
Stock-based compensation expense
   835   824 
Amortization of right to use lease asset
   20   17 
Non-cash
interest expense
   107   43 
Change in fair value of derivative
   172   0   
Changes in operating assets and liabilities:
         
Prepaid expenses and other assets
   587   377 
Accounts payable, accrued expenses and other liabilities
   707   1,434 
   
 
 
  
 
 
 
Net cash flows from operating activities
   (12,359  (6,975
   
 
 
  
 
 
 
CASH FLOWS FROM FINANCING ACTIVITIES:
         
Net proceeds from convertible note payable – related party
   10,000   0   
Net proceeds from issuance of common stock
   6,815   263 
   
 
 
  
 
 
 
Net cash flows from financing activities
   16,815   263 
   
 
 
  
 
 
 
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
   4,456   (6,712
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
   27,142   47,480 
   
 
 
  
 
 
 
CASH AND CASH EQUIVALENTS, END OF PERIOD
  $31,598  $40,768 
   
 
 
  
 
 
 
NONCASH FINANCING ACTIVITIES:
         
Payment of preferred stock dividends in common stock
  $67  $60 
Fair value of derivative related to related party convertible note payable
   420   0   
Reclassification of accrued bonus to additional paid in capital
   60   0   
See notes to unaudited condensed consolidated financial statements.

5

Table of Contents
GALECTIN THERAPEUTICS INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (UNAUDITED)
(amounts in thousands except share data)
         
   
Series C Super
Dividend Redeemable
Convertible
Preferred Stock
 
   
Number of
Shares
   
Amount
 
Balance at December 31, 2019
  
 
176
 
  
$
1,723
 
   
 
 
   
 
 
 
Balance at June 30, 2020
  
 
176
 
  
$
1,723
 
   
 
 
   
 
 
 
Balance at December 31, 2020
  
 
176
 
  
$
1,723
 
   
 
 
   
 
 
 
Balance at June 30, 2021
  
 
176
 
  
$
1,723
 
   
 
 
   
 
 
 
See notes to unaudited condensed consolidated financial statements.
6

Table of Contents
GALECTIN THERAPEUTICS INC.
CONSOLIDATED STATEMENTS OF CHANGES IN REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) — (Continued)
For the Three Months Ended June 30, 2021 and 2020
(amounts in thousands except share data)
   
Series A 12%
Convertible
Preferred Stock
   
Common Stock
            
   
Number
of
Shares
   
Amount
   
Number
of
Shares
   
Amount
   
Additional
Paid-In

Capital
   
Retained
Deficit
  
Total
Stockholders’
Equity
(Deficit)
 
Balance at March 31, 2020
  
 
1,327,500
 
  
$
537
 
  
 
57,029,209
 
  
$
56
 
  
$
260,382
 
  
$
(219,945
 
$
41,030
 
Series A 12% convertible preferred stock dividend
                            (40  (40
Series C super dividend redeemable convertible preferred stock dividend
                            (26  (26
Issuance of common stock
             14,452         44        44 
Stock-based compensation expense
                       394        394 
Net loss
                            (6,114  (6,114
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Balance at June 30, 2020
  
 
1,327,500
 
  
$
537
 
  
 
57,043,661
 
  
$
56
 
  
$
260,820
 
  
$
(226,125
 
$
35,288
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Balance at March 31, 2021
  
 
1,302,500
 
  
$
527
 
  
 
57,186,655
 
  
$
56
 
  
$
262,264
 
  
$
(246,336
 
$
16,511
 
Series A 12% convertible preferred stock dividend
                            (38  (38
Series C super dividend redeemable convertible preferred
stock dividend
                      
(27)
   
(27)
 
Issuance of common stock
             845,214    1    3,863        3,864 
Issuance of common stock from exercise of warrants and options
             1,243,162    2    2,949        2,951 
Stock-based compensation expense
                       581        581 
Net loss
                            (8,449  (8,449
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Balance at June 30, 2021
  
 
1,302,500
 
  
$
527
 
  
 
59,275,031
 
  
$
59
 
  
$
269,657
 
  
$
(254,850
 
$
15,393
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
7

Table of Contents
GALECTIN THERAPEUTICS INC.
CONSOLIDATED STATEMENTS OF CHANGES IN REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) — (Continued)
For the Six Months Ended June 30, 2021 and 2020
(amounts in thousands except share data)
   
Series A 12%
Convertible
Preferred Stock
   
Common Stock
            
   
Number
of
Shares
   
Amount
   
Number
of
Shares
   
Amount
   
Additional
Paid-In

Capital
   
Retained
Deficit
  
Total
Stockholders’
Equity
(Deficit)
 
Balance at December 31, 2019
  
 
1,327,500
 
  
$
537
 
  
 
56,894,642
 
  
$
56
 
  
$
259,673
 
  
$
(216,394
 
$
43,872
 
Series A 12% convertible preferred stock dividend
             13,275         26    (26    
Series C super dividend redeemable convertible preferred stock dividend
             17,600         34    (35  (1
Issuance of common stock
             14,452         44        44 
Issuance of common stock for exercise of warrants and options
             84,624         219        219 
Stock-based compensation expense
             19,068         824        824 
Net loss
                            (9,670  (9,670
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Balance at June 30, 2020
  
 
1,327,500
 
  
$
537
 
  
 
57,043,661
 
  
$
56
 
  
$
260,820
 
  
$
(226,125
 
$
35,288
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Balance at December 31, 2020
  
 
1,302,500
 
  
$
527
 
  
 
57,077,055
 
  
$
56
 
  
$
261,883
 
  
$
(239,996
 
$
22,470
 
Series A 12% convertible preferred stock dividend
             13,025         28    (28    
Series C super dividend redeemable convertible preferred stock dividend
             17,600         39    (39    
Issuance of common stock
             845,214    1    3,863        3,864 
Issuance of common stock for exercise of warrants and options
             1,289,444    2    2,949        2,951 
Stock-based compensation expense
             32,693         895        895 
Net loss
                            (14,787  (14,787
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Balance at June 30, 2021
  
 
1,302,500
 
  
$
527
 
  
 
59,275,031
 
  
$
59
 
  
$
269,657
 
  
$
(254,850
 
$
15,393
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
See notes to consolidated financial statements.
8

Table of Contents
GALECTIN THERAPEUTICS INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1. Basis of Presentation

Galectin Therapeutics Inc. and subsidiaries (the “Company”) is a clinical stage biopharmaceutical company that is applying its leadership in galectin science and drug development to create new therapies for fibrotic disease skin diseases and cancer. These candidates are based on the Company’s targeting of galectin proteins which are key mediators of biologic and pathologic function. These compounds also may have application for drugs to treat other diseases and chronic health conditions.

The unaudited condensed consolidated financial statements as reported in this Quarterly Report on Form
10-Q
reflect all adjustments which are, in the opinion of management, necessary to present fairly the financial position of the Company as of SeptemberJune 30, 20172021 and the results of its operations for the three and ninesix months ended SeptemberJune 30, 20172021 and 20162020 and its cash flows for the ninethree and six months ended SeptemberJune 30, 20172021 and 2016.2020. All adjustments made to the interim financial statements include all those of a normal and recurring nature. Amounts presented in the condensed consolidated balance sheet as of December 31, 20162020 are derived from the Company’s audited consolidated financial statements as of that date, but do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. Subsequent events have been evaluated through the date these financial statements are available to be issued. The results for interim periods are not necessarily indicative of results whichthat may be expected for any other interim period or for the full year. The unaudited condensed consolidated financial statements of the Company should be read in conjunction with its Annual Report on Form
10-K
for the year ended December 31, 2016.

2020.

The Company has operated at a loss since its inception and has had no significant revenues. The Company anticipates that losses will continue for the foreseeable future. At SeptemberJune 30, 2017,2021, the Company had $7.0 million$31,598,000 of unrestricted cash and cash equivalents available to fund future operations. The Company believes that with the cash on hand at September 30, 2017, there is sufficient cash, including availability of the line of credit (see Note 3), to fund currently planned operations at least through February 2018 which creates uncertainty aboutSeptember 30, 2022. We will require more cash to fund our operations after September 30, 2022 and believe we will be able to obtain additional financing. The currently planned operations include costs related to our adaptively designed NAVIGATE Phase 2b/3 clinical trial. Currently, we expect to require an additional approximately
$30-$35 million
to cover costs of the Company’s abilitytrial to continue as a going concern. The Company’s abilityreach the planned interim analysis estimated to occur in the second half of 2023 along with drug manufacturing and other scientific support activities and general and administrative costs. However, there can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us. If we are unsuccessful in raising additional capital to fund operations after its current cash resources are exhausted depends on its abilitybefore September 30, 2022, we may be required to obtain additional financing or achieve profitable operations, as to which no assurances can be given.cease operations. Accordingly, based on the forecasts and estimates underlying the Company’sour current operating plan, substantial doubt exists about the ability for the Company to continue as a going concern. The financial statements do not currently include any adjustments that might be necessary if the Company iswe are unable to continue as a going concern.

The Company was founded in July 2000, was incorporated in the State of Nevada in January 2001 under the name
“Pro-Pharmaceuticals,
Inc.,” and changed its name to “Galectin Therapeutics Inc.” on May 26, 2011.

2. Accrued Expenses

and Other

Accrued expenses consist of the following:

   September 30,
2017
   December 31,
2016
 
   (in thousands) 

Legal and accounting fees

  $115   $14 

Accrued compensation

   361    614 

Accrued research and development costs and other

   3,699    2,174 
  

 

 

   

 

 

 

Total

  $4,175   $2,802 
  

 

 

   

 

 

 

   June 30,
2021
   December 31,
2020
 
   (in thousands) 
Legal and accounting fees
  $94   $122 
Accrued compensation
   370    789 
Lease liability
   31    44 
Accrued research and development costs and other
   4,570    3,087 
   
 
 
   
 
 
 
Total
  $5,065   $4,042 
   
 
 
   
 
 
 
Research and development expenses, including personnel costs, allocated facility costs, lab supplies, outside services, contract laboratory costs related to manufacturing drug product, clinical trials and preclinical studies are charged to research and development expense as incurred. The Company accounts for nonrefundable advance payments for goods and services that will be used in future research and development activities as expense when the service has been performed or when the goods have been received. Our current NAVIGATE clinical trial is being supported by third-party contract research organizations, or CROs, and other vendors. We accrue expenses for clinical trial activities performed by CROs based upon the estimated amount of work completed on each trial. For clinical trial expenses and related expenses associated with the conduct of clinical trials, the significant factors used in estimating accruals include the number of patients enrolled, the number of active clinical sites, and the duration for which the patients have been
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enrolled in the trial. We monitor patient enrollment levels and related activities to the extent possible through internal reviews, review of contractual terms and correspondence with CROs. We base our estimates on the best information available at the time. We monitor patient enrollment levels and related activities to the extent possible through discussions with CRO personnel and based our estimates of clinical trial costs on the best information available at the time. However, additional information may become available to us which will allow us to make a more accurate estimate in future periods. In that event, we may be required to record adjustments to research and development expenses in future periods when the actual level of activity becomes more certain.
3. Line of Credit – Related Party
The Company has a $10 million Line of Credit arrangement with Richard E. Uihlein, Chairman of Board of Directors and a shareholder pursuant to an agreement established in December, 2017 and amended in December, 2018 and January, 2019. Under the arrangement the Company may borrow up to $10 million from Mr. Uihlein on an unsecured basis and with any borrowings bearing interest at the Applicable Federal Rate for short terms loans published by the Internal Revenue Service (0.13% in June 2021). Borrowings may be made through December 31, 2021 with repayment due on December 31, 2022. In connection with the Line of Credit agreement, the Company issued to Mr. Uihlein warrants to purchase 1 million shares of the Company’s common stock for $5 per share. Half of the warrants vested at closing of the Line of Credit and the other half vest ratably with borrowings under the agreement. The 500,000 warrants that vested at closing were exercised in May 2019 for cash proceeds to the Company of $2.5 million. As of the date of this Quarterly Report, there have been 0 borrowings under the Line of Credit.
The fair value of the 500,000 warrants vested at closing in December 2017 was $696,000 at the date of issuance based on the following assumptions: an expected life of 7 years, volatility of 98%, risk free interest rate of 2.05% and0 dividends. The fair value of the vested warrants was recorded in other current assets and other assets
(non-current)
as a deferred financing cost and were to be amortized on a straight-line basis from December 19, 2017 through December 31, 2019. The remaining unamortized balance of the deferred financing cost on January 11, 2019 was adjusted to be recorded as expense on a straight-line basis through December 31, 2022. Amortization for the six months ended June 30, 2021 and 2020 of $43,000 and $43,000, respectively, was recorded as interest expense. The fair value of warrants that vest in the future based on borrowings will be computed when those borrowings occur and amortized over the remaining period through December 31, 2022 reflecting the second extension.
4. Convertible Note Payable – Related Party
On April 16, 2021, the Company and Richard E. Uihlein entered into a debt financing arrangement whereby Mr. Uihlein loaned $10,000,000 to Company. In consideration for the loan, the Company issued a convertible promissory note (the “Note”) in the principal amount of 10 million dollars.
The Note has a maturity date of April 16, 2025, is prepayable at the option of the Company in whole or in part at any time, and is convertible into the Company’s common stock at a conversion price equal to $5.00 per share at the option of the noteholder. The Note bears interest at the rate of two percent (2%) per annum, compounded annually. For the period ended June 30, 2021, approximately $41,000 of interest expense was accrued and included with the principal in the financial statements.
The Note also includes a contingent interest component that requires the Company to pay additional interest at a rate of two and one-half percent
(2.5%) per quarter (10% per annum) (the “Additional Interest”) beginning on the date of issuance of this Note and ending on the maturity date, provided however, that such payment is only required if and only if the noteholder elects to convert the entire balance of the Note into the Company’s common stock on or prior to maturity. As the contingent event is not based on creditworthiness, such feature is not clearly and closely related to the host instrument and accordingly must be bifurcated and recognized as a derivative liability and a debt discount on the Note at its inception. The fair value of the contingent interest derivative liability was $420,000 and $592,000 at note inception (April 16, 2021) and June 30, 2021, respectively, and is recognized as a derivative liability in the consolidated balance sheet. The change in the fair value of the derivative liability from April 16, 2021 to June 30, 2021 of $172,000 was charged to other expense for the three-month period ended June 30, 2021. The amortization of the debt discount of $420,000 recorded initially upon note inception of $22,000 was recorded as additional interest expense for the for the three-month period ended June 30, 2021.
The Company’s contractual cash obligations related to the outstanding convertible note payable is a repayment of the $10,000,000 plus accrued interest on April 16, 2025, unless converted at the option of the noteholder.
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5. Stock-Based Compensation

Following is the stock-based compensation expense related to common stock options, common stock, restricted common stock, and common stock warrants:

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2017   2016   2017   2016 

Research and development

  $109   $165   $407   $598 

General and administrative

   121    211    422    1,403 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total stock-based compensation expense

  $230   $376   $829   $2,001 
  

 

 

   

 

 

   

 

 

   

 

 

 

warrants and deferred stock units:

   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
   
2021
   
2020
   
2021
   
2020
 
   
in thousands
 
Research and development
  $89   $83   $156   $240 
General and administrative
   492    311    679    584 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total stock-based compensation expense
  $581   $394   $835   $824 
   
 
 
   
 
 
   
 
 
   
 
 
 
The following table summarizes the stock option activity in the Company’s equity incentive plans, including
non-plan
grants to Company executives, from December 31, 20162020 through SeptemberJune 30, 2017:

   Shares   Weighted Average
Exercise Price
 

Outstanding, December 31, 2016

   4,656,888   $4.30 

Granted

   —      —   

Exercised

   —      —   

Options forfeited/cancelled

   —      —   
  

 

 

   

Outstanding, September 30, 2017

   4,656,888   $4.30 
  

 

 

   

2021:

   Shares   Weighted Average
Exercise Price
 
Outstanding, December 31, 2020
   3,987,575   $4.29 
Granted
   2,065,000    2.20 
Exercised
   (252,500   2.19 
Options forfeited/cancelled
   (880,350   5.52 
   
 
 
      
Outstanding, June 30, 2021
   4,919,725   $3.30 
   
 
 
      
As of SeptemberJune 30, 2017,2021, there was $366,000$3,532,185 of unrecognized compensation related to 907,4892,413,751 unvested options, which is expected to be recognized over a weighted-averageweighted–average period of approximately 0.582.15 years. The weighted-average grant date fair value for options granted during the ninesix months ended SeptemberJune 30, 20162021 was $1.05.$1.63. The Company granted 277,5002,065,000 stock options during the ninesix months ended SeptemberJune 30, 2016, of which 69,375 options vested upon grant with2021. During the remaining 208,125 options vesting over 3 years. Approximately $73,000 ofnon-cash, stock-based compensation expense was recorded during the ninesix months ended SeptemberJune 30, 2016 related to2021, 252,500 stock options were exercised on a net basis resulting in the options granted during the quarter that were vested upon the grant date.

issuance of 109,201 shares of common stock.

The fair value of all other options granted is determined using the Black-Scholes option-pricing model. The following weighted average assumptions were used:

Nine
Months Ended
September 30,
2016

Risk-free interest rate

1.7

Expected life of the options

6.0 years

Expected volatility of the underlying stock

94

Expected dividend rate

0

The following table summarizes the

   Six
Months Ended
June 30,
  Six
Months Ended
June 30,
 
   2021  2020 
Risk-free interest rate
   0.57  1.55
Expected life of the options
   6 years   6 years 
Expected volatility of the underlying stock
   91  100
Expected dividend rate
   0  0
In January 2020, two directors elected to take restricted stock grant activitygrants in the Company’s equity incentive plans from December 31, 2016 through September 30, 2017:

Shares

Outstanding, December 31, 2016

754,605

Granted

—  

Exercised

—  

Options forfeited/cancelled

—  

Outstanding, September 30, 2017

754,605

On March 12, 2015, the Company granted 81,352lieu of cash retainers for 2020. A total of 32,693 shares of restricted stock tonon-employee directors as a component of their compensation. A total of 77,784 shares were issuedvalued at approximately $93,500 was amortized to seven directors representingnon-cash compensation cost of $280,000 which was recognizedexpense on a straight-line basis from the grant date through December 15, 2016,until January 9, 2021 when the restricted sharesstock vested in full.

In March 2021, one director elected to take a restricted stock grant in lieu of cash retainers for 2021. A total of 3,56816,588 shares were issuedof restricted stock valued at approximately $35,000 is being amortized to two directors, who were not nominated for reelection, representingnon-cash compensation cost of $12,845 that was recognizedexpense on a straight-line basis fromuntil December 31, 2021 when the stock vests in full.
In September 2020, the Company entered into an employment agreement with its new Chief Executive Officer whereby 20% of his base salary and performance bonuses will be paid in cash, and 80% will be paid in the form of deferred stock units (“
DSUs
”) in accordance with the terms and subject to the provisions set forth in the DSU Agreement. DSUs credited to Mr. Lewis as of any date shall be fully vested and nonforfeitable at all times. The Company shall issue the shares underlying the outstanding whole number of DSUs credited to Mr. Lewis as follows: twenty five percent shall be issued on March 1, 2023, twenty five percent shall be issued on September 1, 2023 and fifty percent shall be issued on March 1, 2024. For the six months ended June 30, 2021, $200,000 of his compensation was recorded as stock compensation expense representing 73,946 shares of common stock to be issued under the DSU agreement with a weighted average grant date through May 21, 2016, whenfair value of $2.70 per share. Also, Mr. Lewis’ bonus for the restrictedyear ended December 31, 2020 of $60,000 (which was included in accrued compensation at December 31, 2020) was approved in March 2021 and represents 27,027 shares vestedof common stock to be issued under the DSU agreement with a grant date fair value of $2.22 per share. The $60,000 was reclassified from accrued compensation to additional paid in full.

4.capital in March 2021. There is 0 unrecognized compensation expense related to the DSUs.

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6. Common Stock Warrants

The following table summarizes the common stock warrant activity from December 31, 20162020 through SeptemberJune 30, 2017:

   Shares   Weighted Average
Exercise Price
 

Outstanding, December 31, 2016

   13,488,296   $3.44 

Granted

   78,455    5.00 

Exercised

   —      —   

Forfeited/cancelled

   (1,317,161   5.63 
  

 

 

   

Outstanding, September 30, 2017

   12,249,590   $3.22 
  

 

 

   

5.2021:

   Shares   Weighted Average
Exercise Price
 
Outstanding, December 31, 2020
   12,538,204   $4.22 
Granted
   0—      0—   
Exercised
   (1,180,240   2.50 
Forfeited/cancelled
   0—      0—   
   
 
 
      
Outstanding, June 30, 2021
   11,357,964   $4.40 
   
 
 
      
The weighted average expiration of the warrants outstanding as of June 30, 2021 is 3.2 years.
7. Fair Value of Financial Instruments

The Company has certain financial assets and liabilities recorded at fair value. Fair values determined by Level 1 inputs utilize observable data such as quoted prices in active markets. Fair values determined by Level 2 inputs utilize data points other than quoted prices in active markets that are observable either directly or indirectly. Fair values determined by Level 3 inputs utilize unobservable data points in which there is little or no market data, which require the reporting entity to develop its own assumptions. The carrying amounts reflected in the consolidated balance sheets for cash equivalents, accounts payable and accrued expenses approximate their carrying value due to their short-term nature. There were no level 2 or level 3 assets or liabilities at September 30, 2017 or December 31, 2016.

6.2020.

Assets and liabilities measured and recorded at fair value on a recurring basis at the end of June 30, 2021 were as follows:
   Level 1   Level 2   Level 3   Total 
Derivative Liability – Contingent Interest
                                  $592,000   $592,000 
The derivative liability – contingent interest was valued using a Monte Carlo Geometric Brownian Stock Path Model. The key assumptions used in the model at inception, and at June 30, 2021 are as follows:
   
Inception
  
June 30, 2021
 
Stock Price
  $2.19  $3.20 
Conversion Price of conversion feature
  $5.00  $5.00 
Term
   4 years   3.8 years 
Risk Free Interest Rate
   0.59  0.67
Credit Adjusted Discount Rate
   7.60  7.11
Volatility
   88  91
Dividend Rate
   0  0 
The roll forward of the derivative liability – contingent interest is as follows:
Balance – December 31, 2020
  $0   
Issuance of convertible note payable – related party
   420,000 
Fair Value Adjustment
   172,000 
   
 
 
 
Balance – June 30, 2021
  $592,000 
8. Loss Per Share

Basic net loss per common share is computed by dividing the net loss available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing the net loss available to common stockholders by the weighted average number of common shares and other potential common shares then
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outstanding. Potential common shares consist of common shares issuable upon the assumed exercise of
in-the-money
stock options and warrants and potential common shares related to the conversion of the preferred stock. The computation of diluted net loss per share does not assume the issuance of common shares that have an anti-dilutive effect on net loss per share.

Dilutive shares which could exist pursuant to the exercise of outstanding stock instruments and which were not included in the calculation because their affect would have been anti-dilutive are as follows:

   September 30, 2017
(shares)
   September 30, 2016
(shares)
 

Warrants to purchase shares of common stock

   12,249,590    10,452,844 

Options to purchase shares of common stock

   4,656,888    3,499,638 

Shares of common stock issuable upon conversion of preferred stock

   4,312,282    3,415,285 

Unvested shares of restricted common stock

   —      337,935 
  

 

 

   

 

 

 
   21,218,760    17,705,702 
  

 

 

   

 

 

 

7.

   June 30, 2021
(shares)
   June 30, 2020
(shares)
 
Warrants to purchase shares of common stock
   11,357,964    12,538,204 
Options to purchase shares of common stock
   4,919,725    3,737,575 
Shares of common stock issuable upon conversion of convertible note payable
  
2,049,428
   
0
 
Shares of common stock issuable upon conversion of preferred stock
   510,424    514,602 
   
 
 
   
 
 
 
   18,837,541   16,790,381 
   
 
 
   
 
 
 
9. Common Stock

2014

2020 At Market Issuance of Common Stock

On March 30, 2014,May 11, 2020, the Company entered into an At Market Issuance Sales Agreement (the “2014“2020 At Market Agreement”) with a sales agent under which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $30.0$40.0 million from time to time through the sales agent. Sales of the Company’s common stock through the sales agent, if any, will be made by any method that is deemed an “at the market” offering as defined by the U.S. Securities and Exchange Commission. The Company will pay to the sales agent a commission rate equal to 3.0% of the gross proceeds from the sale of any shares of common stock sold through the sales agent under the 2014 At Market Agreement. In three months ended June 30, 2016, the Company issued 176,950 shares of common stock for net proceeds of approximately $257,000 under the 2014 At Market Agreement.    In three months ended March 31, 2017, the Company issued 1,496,797 shares of common stock for net proceeds of approximately $1,946,000 under the 2014 At Market Agreement.    The 2014 At Market Agreement expired in March 2017.

2017 At Market Issuance of Common Stock

On May 19, 2017, the Company entered into an At Market Issuance Sales Agreement (the “2017 At Market Agreement”) with a sales agent under which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $30.0 million from time to time through the sales agent. Sales of the Company’s common stock through the sales agent, if any, will be made by any method that is deemed an “at the market” offering as defined by the U.S. Securities and Exchange Commission. The Company will pay to the sales agent a commission rate equal to 3.0% of the gross proceeds from the sale of any shares of common stock sold through the sales agent under the 20172020 At Market Agreement. During the ninesix months ended SeptemberJune 30, 2017,2021, the Company issued 716,563845,214 shares of common stock under the 2020 At Market Agreement for net proceeds of approximately $1,438,000 under$3,864,000.

For the 2017 At Market Agreement.

2017 Private Placement

On February 28, 2017, the Company closed a transaction with five individual investors through a private placement of common stocksix months ended June 30, 2021 and warrants. In total,2020, the Company issued 102,368a total of 30,625 and 30,875 shares of common stock, for proceeds of $200,000. The Company also issued, to the five investors, warrants to purchase 76,776 shares of common stock at $5.00 per share. The warrants have an expiration date of February 28, 2024. The exercise price of each warrant is adjustable in the event of a stock split or stock combination, capital reorganization, merger or similar event. The warrants were valued at approximately $101,000 as of the issuance, using the closing price of $1.86, a life of 7 years, a volatility of 97% and a risk-free interest rate of 1.92%. Based upon the Company’s analysis of the criteria contained in ASC Topic815-40, “Derivatives and Hedging — Contracts in Entity’s Own Equity” the Company has determined that warrants issued in connection with this financing transaction were not derivative liabilities and therefore, were recorded as additionalpaid-in capital.

Other

In 2017, the Company entered an agreement with a vendor whereby the Company will issue common stock to vendor in lieu of paying in cash in amount up to $100,000 for the year. Through September 30, 2017, the Company has issued 16,793 shares of common stock and 1,680 warrants to purchase shares of common stock pursuant to this agreement and the value of such shares has been recorded as research and development expense.

Through September 30, 2017, the Company has issued a total of 393,235 shares of common stockrespectively, for dividends on Series A Series B and Series C Preferred Stock for 2017.

8.Stock.

10. Commitments and Contingencies

Shareholder Class Actions and Derivative Lawsuits

On August 1 and 25, 2014, persons claiming to be Galectin shareholders filed putative shareholder derivative complaints in the Nevada District Court, seeking recovery on behalf of the Company against certain of the Company’s directors and officers. On September 10, 2014, the Nevada District Court entered an order consolidating the two cases, relieving the defendants of any obligation to respond to the initial complaints, and providing that defendants may respond to a consolidated complaint to be filed by the plaintiffs. On January 5, 2015, the Nevada District Court granted Defendants’ motion to transfer the consolidated putative derivative litigation to the United States District Court for the Northern District of Georgia (hereinafter referred to as the “Georgia Federal Derivative Action.”). The plaintiffs filed a consolidated complaint on February 27, 2015. On April 6, 2015, the Company and defendants filed motions to dismiss the consolidated complaint. Rather than respond to those motions, the plaintiffs sought and obtained leave to file an amended complaint. Plaintiffs filed their amended complaint (the “Complaint”) on May 26, 2015. The Complaint alleges that certain of the Company’s directors and officers (the “Derivative Action Individual Defendants”) breached their fiduciary duties to the Company’s shareholders by causing or permitting the Company to make allegedly false and misleading public statements concerning the Company’s financial and business prospects. The Complaint also alleges that the Derivative Action Individual Defendants violated the federal securities laws by allegedly making false or misleading statements of material fact in the Company’s proxy filings, committed waste of corporate assets, were unjustly enriched, and that certain defendants breached their fiduciary duties through allegedly improper sales of Galectin stock. In addition, the Complaint alleges that the Derivative Action Individual Defendants and one of the Company’s shareholders aided and abetted the alleged breaches of fiduciary duties. The Complaint seeks unspecified monetary damages on behalf of the Company, corporate governance reforms, disgorgement of profits, benefits and compensation by the defendants, costs, and attorneys’ and experts’ fees. The Company and defendants filed motions to dismiss the Complaint on July 8, 2015. On December 30, 2015, the United States District Court for the Northern District of Georgia dismissed the Georgia Federal Derivative Action with prejudice and entered a final judgment in favor of the defendants. Plaintiffs filed a notice of appeal seeking review of the dismissal order and final judgment. On July 7, 2016, the United States Court of Appeals for the Eleventh Circuit dismissed the appeal as the Plaintiffs failed to timely file their appeal brief. In September 2016, the Board received a demand letter from one of the plaintiffs in the Georgia Federal Derivative Action. The demand letter, among other things, requests that the Board investigate the conduct alleged in the Complaint and implement certain remedial measures purportedly designed to address the alleged conduct. It is expected that the Board will consider the demand letter in due course and in light of the related pending shareholder litigation described herein.

On August 29, 2014, another alleged Galectin shareholder filed a putative shareholder derivative complaint in state court in Las Vegas, Nevada, seeking recovery on behalf of the Company against the same Galectin directors and officers who are named as defendants in the derivative litigation pending in the Georgia Federal Derivative Action. The plaintiff in the Nevada action subsequently filed first and second amended complaints. The second amended complaint alleges claims for breach of fiduciary duties, unjust enrichment, and waste of corporate assets, based on allegations that are substantially similar to those asserted in the Georgia Federal Derivative Action (except that the Nevada action does not allege violations of the federal securities laws and does not assert any claim against the Galectin shareholder named as a defendant in the Georgia Federal Derivative Action), and seeks unspecified monetary damages on behalf of the Company, corporate governance reforms, disgorgement of profits, benefits and compensation by the defendants, costs, and attorneys’ and experts’ fees. The Company and defendants filed motions to dismiss the second amended complaint on April 22, 2015. On April 29, 2015, the plaintiffs in the Georgia Federal Derivative Action (the “Intervenor Plaintiffs”) filed a motion to intervene in the Nevada action which, among other things, raised questions regarding the Nevada plaintiff’s standing. Thereafter, the Nevada plaintiff filed a motion to join additional plaintiffs. At a hearing held on June 11, 2015, the Nevada court: (i) granted the Intervenor Plaintiffs’ motion to intervene; (ii) directed the Intervenor Plaintiffs to file a complaint in intervention; (iii) directed the Nevada plaintiff to file a motion for leave to file a further amended complaint to add additional plaintiffs; (iv) stated that the defendants’ motions to dismiss the second amended complaint were denied “at this point;” (v) ordered the Nevada action stayed until December 11 , 2015; and (vi) directed the parties to submit a status report on December 11, 2015, updating the court on the progress and status of the Georgia Federal Derivative Action. On July 9, 2015, pursuant to the Nevada State Court’s instruction, the Intervenor Plaintiffs filed acomplaint-in-intervention in Nevada State Court, asserting similar claims to the ones they alleged in the Georgia Federal Derivative Action described above. On December 11, 2015, further to the Nevada State Court’s instruction, the parties submitted status reports detailing the status of the Georgia Federal Derivative Action. On January 5, 2016, the Nevada State Court held a status conference during which the dismissal of the Georgia Federal Derivative Action was discussed. Subsequent to that conference, on January 19, 2016, the defendants filed a motion to dismiss the Nevada State Court litigation based on the dismissal of the similar Georgia Federal Derivative Action, among other grounds. Following full briefing and a hearing on March 3, 2016, the Nevada State Court granted dismissal of the Nevada State Court litigation. Notice of Entry of the Nevada State Court’s order dismissing the Nevada State Court litigation was docketed on June 21, 2016. The Nevada plaintiff and Intervenor Plaintiffs (“Appellants”) filed notices of appeal seeking review of the Nevada State Court’s order and judgment dismissing the claims. The appeal is now fully briefed and awaiting a decision from the Nevada Supreme Court.

Estimating an amount or range of possible losses resulting from litigation proceedings is inherently difficult and requires an extensive degree of judgment, particularly where the matters involve indeterminate claims for monetary damages, are in the early stages of the proceedings, and are subject to appeal. In addition, because most legal proceedings are resolved over extended periods of time, potential losses are subject to change due to, among other things, new developments, changes in legal strategy, the outcome of intermediate procedural and substantive rulings and other parties’ settlement posture and their evaluation of the strength or weakness of their case against us. For these reasons, we are currently unable to predict the ultimate timing or outcome of, or reasonably estimate the possible losses or a range of possible losses resulting from, the matters described above. Based on information currently available, the Company does not believe that any reasonably possible losses arising from currently pending legal matters will be material to the Company’s results of operations or financial condition. However, in light of the inherent uncertainties involved in such matters, an adverse outcome in one or more of these matters could materially and adversely affect the Company’s financial condition, results of operations or cash flows in any particular reporting period.

Other Legal Proceedings

The Company records accruals for such contingencies to the extent that the Company concludes that their occurrence is probable and the related damages are estimable. There are no othersignificant pending legal proceedings exceptproceedings.
Clinical Trial and Research Commitments
The Company has entered into agreements with contractors for research and development activities to further its product candidates. The contracts generally may be canceled at any time by providing thirty days’ notice.
11. Leases
The Company has one operating lease for its office space which was amended effective January 1, 2019 for a term of 38 months with no residual value guarantees or material restrictive covenants. The amended lease provided for free rent for the first two months of the lease and continues the security deposit of $6,000. In addition to base rental payments included in the contractual obligations table above, the Company is responsible for our
pro-rata
share of the operating expenses for the building. Our lease cost for the
six-month
periods ended June 30, 2021 and 2020 was $22,000 for each period and is included in general and administrative expenses. As of June 30, 2021, the right to use lease asset consisted of $28,000 and is included in other assets. Also, at June 30, 2021, current lease liability of $31,000 is included in accrued expenses.
Maturity of operating lease as noted above.

9.of June 30, 2021 in thousands:

2021
   24 
2022
   8 
   
 
 
 
Total
   32 
Less imputed interest
   1 
   
 
 
 
Present value of lease liability
  $31 
   
 
 
 
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The discount rate used in calculating the present value of the lease payments was 11.04%
12. Galectin Sciences LLC

In January 2014, we created Galectin Sciences, LLC (the “LLC” or “Investee”), a collaborative joint venture
co-owned
by SBH Sciences, Inc. (“SBH”), to research and develop small organic molecule inhibitors of
galectin-3
for oral administration. The LLC was initially capitalized with a $400,000 cash investment to fund future research and development activities, which was provided by the Company, and specific
in-process
research and development (“IPR&D”) contributed by SBH. The estimated fair value of the IPR&D contributed by SBH, on the date of contribution, was $400,000. Initially, the Company and SBH each had a 50% equity ownership interest in the LLC, with neither party having control over the LLC. Accordingly, from inception through the fourth quarter of 2014, the Company accounted for its investment in the LLC using the equity method of accounting. Under the equity method of accounting, the Company’s investment was initially recorded at cost with subsequent adjustments to the carrying value to recognize additional investments in or distributions from the Investee, as well as the Company’s share of the Investee’s earnings, losses and/or changes in capital. The estimated fair value of the IPR&D contributed to the LLC was immediately expensed upon contribution as there was no alternative future use available at the point of contribution. The operating agreement provides that if either party does not desire to contribute its equal share of funding required after the initial capitalization, then the other party, providing all of the funding, will have its ownership share increased in proportion to the total amount contributed from inception. In the fourth quarter of 2014, after the LLC had expended the $400,000 in cash, SBH decided not to contribute its share of the funding required. As a result,Since then, the Company has contributed thea total of $2,529,000, including $73,000 needed for the fourth quarter of 2014three months ended June 30, 2021, for expenses of the LLC. The CompanySince the end of 2014, SBH has contributed $659,000 and $687,000$158,000 for the LLC expenses in 2016 and 2015, respectively, and SBH contributed $50,000 in 2016. The Company contributed $45,000, $29,000 and $30,000 during the quarters ended March 31, 2017,LLC. As of June 30, 2017, and September 30, 2017, respectively. As of September 30, 2017,2021, the Company’s ownership percentage in the LLC was 81.2%84%. The Company accounts for the interest in the LLC as a consolidated, less than wholly owned subsidiary. Because the LLC’s equity is immaterial, the value of the
non-controlling
interest is also deemed to be immaterial.

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

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
In addition to historical information, the following Management’s Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements as defined under Section 21E of the Securities Exchange Act of 1934, as amended, and is subject to the safe harbor created therein for forward-looking statements. Such statements include, but are not limited to, statements concerning our anticipated operating results, research and development, clinical trials, regulatory proceedings, and financial resources, and can be identified by use of words such as, for example, “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” and “would,” “should,” “could” or “may.” All statements, other than statements of historical facts, included herein that address activities, events, or developments that the Company expects or anticipates will or may occur in the future, are forward-looking statements, including statements regarding: plans and expectations regarding clinical trials; plans and expectations regarding regulatory approvals; our strategy and expectations for clinical development and commercialization of our products; potential strategic partnerships; expectations regarding the effectiveness of our products; plans for research and development and related costs; statements about accounting assumptions and estimates; expectations regarding liquidity and the sufficiency of cash to fund currently planned operations through February 2018;at least September 30, 2022; our commitments and contingencies; and our market risk exposure. Forward-looking statements are based on current expectations, estimates and projections about the industry and markets in which Galectin Therapeutics operates, and management’s beliefs and assumptions. These statements are not guarantees of future performance and involve certain known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Such risks and uncertainties are related to and include, without limitation,

our early stage of development,

we have incurred significant operating losses since our inception and cannot assure you that we will generate revenue or profit,

our dependence on additional outside capital,

we may be unable to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates,

uncertainties related to any litigation, including shareholder class actions and derivative lawsuits filed,

uncertainties related to our technology and clinical trials, including expected dates of availability of clinical data,

we may be unable to demonstrate the efficacy and safety of our developmental product candidates in human trials,

we may be unable to improve upon, protect and/or enforce our intellectual property,

we are subject to extensive and costly regulation by the U.S. Food and Drug Administration (FDA) and by foreign regulatory authorities, which must approve our product candidates in development and could restrict the sales and marketing and pricing of such products,

competition and stock price volatility in the biotechnology industry,

limited trading volume for our stock, concentration of ownership of our stock, and other risks detailed herein and from time to time in our SEC reports,

the impact resulting from the outbreak of
COVID-19,
which has delayed and may continue to delay our clinical trial and development efforts, as well as the impact that
COVID-19
has on the volatility of the capital market and our ability to access the capital market and,
other risks detailed herein and from time to time in our SEC reports, including our Annual Report on Form
10-K
filed with the SEC for the fiscal year ended December 31, 2020, and our subsequent SEC filings.
The following discussion should be read in conjunction with the accompanying consolidated financial statements and notes thereto of Galectin Therapeutics appearing elsewhere herein.

    Furthermore, in this Quarterly Report on Form

10-Q,
we refer to other sources of information, such as the information posted on our website or peer reviewed publications. The information from these sources are not incorporated by reference to this Quarterly Report on Form
10-Q.
Overview

We are a clinical stage biopharmaceutical company engaged in drug research and development to create new therapies for fibrotic disease, certain severe skin diseases,cancer and cancer.selected other diseases. Our drug candidates are based on our method of targeting galectin proteins, which are key mediators of biologic and pathologic functions. We use naturally occurring, readily-available plant products as starting material in manufacturing processes to create proprietary, patented complex carbohydrates with specific molecular weights and other pharmaceutical properties. These complex carbohydrate molecules are appropriately formulated into acceptable pharmaceutical formulations. Using these unique carbohydrate-based candidate compounds that largely bind and inhibit galectin proteins, particularly
15

Table of Contents
galectin-3,
we are undertaking the focused pursuit of therapies for indications where galectinsgalectin proteins have a demonstrated role in the pathogenesis of a given disease. We focus on diseases with serious, life-threatening consequences to patients and those where current treatment options, are limited.limited specifically in NASH
(non-alcoholic
steatohepatitis) with cirrhosis and certain cancer indications. Our strategy is to establish and implement clinical development programs that add value to our business in the shortest period of time possible and to seek strategic partners when a programone of our programs becomes advanced and requires significant additional resources.

Our lead
galectin-3
inhibitor isGR-MD-02, belapectin
(GR-MD-02),
which has been demonstrated in preclinical models to reverse liver fibrosis and cirrhosis.GR-MD-02 Belapectin has the potential to treat many diseases due to
galectin-3’s
involvement in multiple key biological pathways such as fibrosis, immune cell function and immunity, cell differentiation, cell growth, and apoptosis (cell death). Galectin Therapeutics Inc.The importance of
galectin-3
in the fibrotic process is supported by experimental evidence. Animals with the gene responsible for
galectin-3
“knocked-out”
can no longer develop fibrosis in response to experimental stimuli compared to animals with an intact
galectin-3
gene. We are using this our
galectin-3
inhibitor to treat advanced liver fibrosis and liver cirrhosis in NASH(non-alcoholic steatohepatitis) patients. We have completed two Phase 1 clinical studies, onea Phase 2 clinical study in NASH patients with advanced fibrosis
(NASH-FX)
and have one

ongoinga second Phase 22b clinical studytrial in NASH patients with well compensated cirrhosis

(NASH-CX). TheNASH-CX trial patients have completed all infusions/dosing and final HVPG and liver biopsy results have been obtained on all patients. The trial is expected to complete with 151 patients and to report top line data in December 2017. NASH cirrhosis is a progressive disease, currently not treatable and ultimately may result in liver failure that has poor prognosis and no effective, approved medical therapies other than liver transplant.Galectin-3 expression is highly increased in
meaning the liver is scarred but still able to perform most of its basic functions.
We are now engaged in a Phase 2b/3 clinical trial. Our study protocol was filed with the FDA on April 30, 2020 for a seamless adaptively-designed Phase 2b/3 clinical study, the NAVIGATE trial (formerly called
NASH-RX),
evaluating the safety and efficacy of its
galectin-3
inhibitor, belapectin
(GR-MD-02),
for the prevention of esophageal varices in patients with liver fibrosis
non-alcoholic
steatohepatitis (NASH) cirrhosis (Further details are available at
www.clinicaltrials.gov
under study NCT04365868); this study began enrolling patients in
Q2-2020.
In September 2020, the Company received a letter from the FDA providing comments, asking questions and liver cirrhosis. We believe that ourgalectin-3 inhibitor, by reducinggalectin-3 atproviding guidance on various aspects of the extra-cellular level, ultimately showingongoing NAVIGATE trial.
Additionally, a strong anti-fibrotic potential may provide a novel treatment for various formsstudy protocol entitled “A Single-dose, Open-label, Pharmacokinetic Study of liver fibrosis.

Belapectin
(GR-MD-02)
in Subjects With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment” has been filed with the FDA to examine the effects of the drug in subjects with normal hepatic function and subjects with varying degrees of hepatic impairment (study details are listed under study NCT04332432 on
www.clinicaltrials.gov
); this study is enrolling patients.
We endeavor to leverage our scientific and product development expertise as well as established relationships with outside sources to achieve cost-effective and efficient drug development. These outside sources, amongst others, provide us with expertise in preclinical models, pharmaceutical development, toxicology, clinical trial operations, pharmaceutical manufacturing, sophisticated physical and chemical characterization, and commercial development. We also have established several collaborative scientific discovery programs with leading experts in carbohydrate chemistry and characterization. These discovery programs are generally aimed at the targeted development of new carbohydrate molecules that bind galectin proteins and offer alternative options to larger market segments inthrough our primary disease indications. We also have establishedmajority-owned joint venture subsidiary, Galectin Sciences LLC, a discovery program aimed at the targeted development of small molecules(non-carbohydrate) (generally,
non-carbohydrate)
that bind galectin proteins and may afford options for alternative means of drug delivery (e.g., oral) and as a result expand the potential uses of our
galectin-3
inhibitor compounds. Three series of composition of matter patents covering discoveries at Galectin Sciences have been filed.
We are also pursuing a development pathway to clinical enhancement and commercialization for our lead compounds in immune enhancementimmuno-oncology for cancer therapy and certain severe skin diseases including moderate to severe plaque psoriasis and severe atopic dermatitis. Ourin collaboration with Providence Portland Cancer Center. However, our clinical development efforts are primarily focused on both liver fibrosis and fatty liver disease as represented by a Phase 2 clinical trial in NASH-cirrhosis which will report top line data in December 2017.NASH. All of our proposed products are presently in development, including
pre-clinical
and clinical trials.

Our Drug Development Programs

Galectins are a class of proteins that are made by many cells in the body, but predominantly in cells of the immune system. As a group, these proteins are able to bind to sugar molecules that are part of other proteins, glycoproteins, in and on the cells of our body. Galectin proteins act as a kind of molecular glue, bringing together molecules that have sugars on them. Galectin proteins, in particular
galectin-3,
are known to be markedly increased in a number of important diseases including inflammatory diseases, scarring of organs (e.g. liver, lung, kidney, and heart) and cancers of many kinds. The increase in galectin protein promotes the disease and is detrimental to the patient. Published data show that mice lackingsubstantiating the importance of
galectin-3
in the fibrotic process arises from gene knockout experiments in animal studies. Mice genetically altered to eliminate the
galectin-3
gene, and thus unable to produce
galectin-3,
are incapable of developing liver fibrosis in response to toxic insult to the liver and in fatty liver disease; they are also incapabledisease as well as development of developing fibrosis in other tissues such as lung, kidney and cardiac.

tissues.

We have one new proprietary chemical entity (NCE) in development,GR-MD-02, belapectin, which has shown promise in preclinical and early clinical studies in treatment of fibrosis, certain severe skin diseases,disease, and in cancer therapy. Currently we are focusing on development ofGR-MD-02 belapectin intended to be used in the treatment of liver fibrosis associated with fatty liver disease (NASH) and more specifically onin NASH cirrhosis. We have also leveraged our relationships with well-known investigators to demonstrate clinical effects ofGR-MD-02 belapectin in treating moderate to severe plaque psoriasis, severe atopic dermatitis, and in cancer therapy in combination with immune-system modifying agent(s).GR-MD-02 Belapectin is a proprietary, patented compound derived from natural, readily available, plant-based starting materials, which, following chemical processing, exhibits the properties of binding to and inhibiting
galectin-3
proteins. A second NCE,
GM-CT-01
is a proprietary, patented compound that is made from a completely different starting source plant material and also binds and inhibits galectin proteins. Previously in clinical development for cancer indications, this
GM-CT-01
compound continues to behas been explored in limited other preclinical studies.

16

Table of Contents
Our product pipeline is shown below:

Indication

  

Drug

  

Status

Fibrosis

    
NASH with Advanced Fibrosis:
NASH-CX
trial and
NASH-FX
trial
  GR-MD-02belapectin  
IND submitted January 2013. Results from the Phase 1 clinical trial were reported in 2014, with final results reported in January 2015. End of
The Phase 1 meeting held with FDA in 2014. Two Phase 2 clinical trials were designed. The NASH CX trial, was designed for patients with cirrhosis, and the NASH FX trial was designed for patients with advanced fibrosis but not cirrhosis. Its principal purpose was to evaluate various imaging modalities. The NASH FX trial top line data was reported in September 2016 and the
The Phase 2 NASH CX trial, was designed for patients with well compensated cirrhosis. The NASH CX trial top line data is expectedwas reported in December 2017.2017 and was published in
Gastroenterology
in 2020.
NASH NAVIGATE
Based on FDA feedback, the NAVIGATE trial is an adaptive Phase 2b/3 trial for the prevention of esophageal varices in NASH patients with compensated cirrhosis. A Phase 2b interim efficacy analysis will be incorporated to confirm previous Phase 2 data, select an optimal dose and reaffirm the risk/benefit of belapectin. The Phase 3 end of study analysis will evaluate the development of esophageal varices as the primary outcome of efficacy and a composite clinical endpoint including progression to varices requiring treatment as a key secondary outcome of efficacy. See www.clinicaltrials.gov NCT04365868. The first patient was randomized in the third quarter of 2020.
A hepatic impairment is being conducted in subjects with normal hepatic function and subjects with varying degrees of hepatic impairment (CF: www.clinicaltrials.gov NCT04332432) and began enrolling patients in the second quarter of 2020.
Lung Fibrosis  GR-MD-02belapectin  In
pre-clinical
development
Kidney Fibrosis  GR-MD-02belapectin  In
pre-clinical
development
Indication
Drug
Status
Cardiac and Vascular Fibrosis  GR-MD-02belapectin and
GM-CT-01
  In
pre-clinical
development

Cancer Immunotherapy

    
Melanoma, Head, Neck Squamous Cell
Carcinoma (HNSCC)
  GR-MD-02belapectin  Investigator IND submitted in December 2013. Phase 1B study in process. A second Phase 1B study began in
Q-1
2016. Investigator IND for that study submitted in September 2015. Early data was reported in February 2017 and studies will continue.additional data were reported in September 2018. A further expansion cohort of patients with melanoma and HNSCC was reported in July 2021.

Psoriasis

    

Moderate to Severe Plaque Psoriasis

Severe Atopic Dermatitis

  GR-MD-02belapectin  IND submitted March 2015. A phasePhase 2a trial in moderate to severe plaque psoriasis patients began in January 2016. Interim data on the first four patients were positive and were reported in May 2016. Further positive data was reported in September 2016. Investigator initiated IND submitted for treatment of three patients with severe atopic dermatitis, with positive preliminary data presented in February 2017. StudiesFurther studies are now completed.dependent on finding a suitable strategic partner which is unlikely.

Fibrosis. GR-MD-02
 Belapectin is our lead product candidate for treatment of fibrotic disease. Our preclinical data show thatGR-MD-02 belapectin has a significant therapeutic effect on liver fibrosis as shown in several relevant animal models. In addition, in NASH animal models,GR-MD-02 belapectin has been shown to reduce liver fat, inflammation, and ballooning degeneration or death(death of liver cells.cells). Therefore, we choseGR-MD-02
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Table of Contents
belapectin as the lead candidate in a development program targeted initially at fibrotic liver disease associated with
non-alcoholic
steatohepatitis (NASH, or fatty liver disease)(NASH). In January 2013, an Investigational New Drug (“IND”) was submitted to the FDA with the goal of initiating a Phase 1 study in patients with NASH and advanced liver fibrosis to evaluate the human safety ofGR-MD-02 belapectin and pharmacodynamics biomarkers of disease. On March 1, 2013, the FDA indicated we could proceed with a US Phase 1 clinical trial forGR-MD-02 belapectin with a development program aimed at obtaining support for a proposed indication ofGR-MD-02 belapectin for treatment of NASH with advanced fibrosis. The Phase 1 trial was completed and demonstrated thatGR-MD-02 belapectin up to 8 mg/kg Lean Body Mass (LBM), i.v. was safe and well tolerated and the human pharmacokinetic data defined a drug dose for use in the planned Phase 2 trials. Additionally, there was evidence of a pharmacodynamic effect ofGR-MD-02 at the 8 mg/kg dose with a decrease in alpha 2 macroglobulin, a serum marker of fibrotic activity, and a reduction in liver stiffness as determined by FibroScan®. An “End of Phase 1 Meeting” was held with FDA which, amongst other items, provided guidance on the primary endpoint for the Phase 2 clinical trial.

tolerated.

Additionally, an open label drug-drug interaction study was completed in healthy volunteers during the second quarter of 2015 withGR-MD-02 belapectin and it showed that with 8 mg/kg LBM dose ofGR-MD-02 belapectin and 2 mg/kg LBM dose of midazolam there was no drug-drug interaction and no serious adverse events or drug-related adverse events were observed. This study was required by the U.S. Food and Drug Administration (FDA) and the primary objective was to determine if single or multiple intravenous (IV) doses ofGR-MD-02 affect the pharmacokinetics (PK) of midazolam. The secondary objective was to assess the safety and tolerability ofGR-MD-02 belapectin when administered concomitantly with midazolam. The lack of a drug interaction in this study enabled Galectin to expand the number of patients eligible for its Phase 2 clinical trial. In addition, shouldGR-MD-02 be approved for marketing, the success of this study supports a broader patient population for the drug label.

Our Phase 2 program in fibrotic disease consistsconsisted of two separate human clinical trials. The firstprimary clinical trial iswas the Phase 2b
NASH-CX
study for one year for patients with NASH with compensated cirrhosis, which began enrolling in June 2015. This study iswas the primary focus of our program and iswas a randomized, placebo-controlled, double-blind, parallel-group Phase 22b trial to evaluate the safety and efficacy ofGR-MD-02 belapectin for treatment of liver fibrosis and resultant portal hypertension in NASH patients with compensated cirrhosis. A smaller, exploratory
NASH-FX
trial was conducted to explore potential use of various
non-invasive
imaging techniques in NASH patients with advanced fibrosis but not cirrhosis.
NASH-FX
Trial:
The
NASH-FX
trial was a Phase 2a pilot trial for patients with NASH and advanced fibrosis that explored use of three
non-invasive
imaging technologies. It was a short, single site, four-month trial in 30 NASH patients with advanced fibrosis (F3), but not cirrhosis (F4), randomized 1:1 to either
9 bi-weekly
doses of 8 mg/kg LBM of belapectin or placebo. The trial did not meet its primary biomarker endpoint as measured using multi-parametric magnetic resonance imaging (LiverMultiScan
(R)
, Perspectum Diagnostics). The trial also did not meet secondary endpoints that measure liver stiffness as a surrogate for fibrosis using, magnetic resonance-elastography and FibroScan
®
score. We, and many experts in the field, now believe that a four-month treatment period was not sufficient to show efficacy results in established advanced liver fibrosis. This small study was also not adequately powered for the secondary endpoints. In the trial, belapectin was found to be safe and well tolerated with no serious adverse events and evidence of a pharmacodynamic effect. These results provided support for further development in NASH.
NASH-CX
Trial:
The
NASH-CX
trial was a larger multi-center clinical trial that explored the use of belapectin for the treatment of liver fibrosis and resultant portal hypertension in patients with well-compensated NASH cirrhosis. Enrollment in this trial was completed in September 2016, and a total of 162 patients at 36 sites in the United States were randomized to receive either 2 mg/kg LBM ofGR-MD-02, belapectin, 8 mg/kg LBM ofGR-MD-02 belapectin or placebo, with approximately 54 patients in each group. Approximately 50% of patients at baseline had esophageal varices (a complication of portal hypertension). The primary endpoint iswas a reduction in change in hepatic venous pressure gradient (HVPG). Patients are receivingreceived an infusion of belapectin or placebo every other week for one year, a total of 26 infusions, and will bewere evaluated to determine the change in HVPG as compared with placebo. HVPG will be correlated with secondarySecondary or exploratory endpoints ofincluded fibrosis on liver biopsy, as well as with measurement of liver stiffness (FibroScan
(R)
) and assessment of liver metabolism (
13
C-methacetin
breath test, Exalenz), which arenon-invasive measures. Top line data readout was reported in December 2017. The study demonstrated a favorable safety profile and clinically meaningful efficacy results in patients without esophageal varices at baseline demonstrated by a prevention of development of varices when compared to placebo.
In the total patient population, the primary endpoint HVPG showed a trend toward benefit with belapectin treatment, but the difference from placebo was not statistically significant. The mean change in HVPG of placebo from baseline to week 54 was 0.3 mm Hg. The mean change in HVPG from baseline was
-0.37
and
-0.42
for the 2 mg/kg LBM dose and 8 mg/kg LBM dose of belapectin, respectively.
In those NASH cirrhosis patients without varices at baseline (about 50% of the liver that may be used in future studies. A late-breaking abstract on screening data results correlating clinicallytotal population), there was a statistically significant portal hypertension and methacetin breath test results was presented at The International Liver Congress™ in Amsterdam on April 20, 2017. The DSMB concluded its third and final revieweffect of the safety and conduct2 mg/kg LBM dose of belapectin on thein-life phase of ourNASH-CX trial and indicated it concurrence with continuation absolute change in HVPG
(-1.08
mm Hg, p<0.01). The effect of the trial8 mg/Kg LBM dose of belapectin on absolute or percent change in HVPG from baseline to week 54 was not significant.
Also because of the clinical relevance of this population, a responder analysis was performed on those patients without varices at baseline. Analysis was performed looking at two groups: those with an equal to or greater than 2 mm Hg decrease in HVPG from baseline or those with an equal to or greater than 2 mm Hg and a greater than or equal to 20% decrease in HVPG from baseline. In both cases, the change observed in the belapectin 2 mg/kg LBM group was statistically significant (p<0.01) while that of the 8 mg/kg LBM group was not.
Over the
54-week
treatment period, in patients without varices there were statistically significantly fewer new varices that developed in the belapectin treatment groups (0% and 4% in the 2 mg/kg LBM and the ‘clean’ safety profile.8 mg/kg LBM, respectively) vs placebo (18%). As esophageal varices can lead to hemorrhagic complication, which can be fatal, we believe the prevention of the timeesophageal varices may represent a clinically relevant measure of their evaluation, therapy had been completedclinical efficacy in 68% of subjects in theNASH-CX trial. As of September 30, 2017, 151 patients (100%) have completed all 52 weeks of infusions in this Phase 2b clinical trial. All of the doses have already been administered and end of study HVPG and liver biopsies have been completed. The dropout rate remains at approximately 7%, which is well below expectations, which may increase the power of the trial. We currently expect approximately 151 subjects will complete the trial in November 2017. This trial was designed, and is being conducted, with a primary endpoint that the U.S. Food and Drug Administration views may be a surrogate for outcomes for registration trials in this patient population. After completion of study endpoints and initial analysis of data, the Company remains on track to report top line data from theNASH-CX trial in early December 2017.

The second trial, our Phase 2a pilot trialNASH-FX for patients with NASH advanced fibrosis that explored usecirrhosis.

18

Table of threenon-invasive imaging technologies, is now complete. ItContents
The major conclusions from the
NASH-CX
trial results were that: i) belapectin had a statistically significant and clinically meaningful effect in improving HVPG vs placebo in patients with NASH cirrhosis who did not have esophageal varices at baseline. This effect was seen regardless of the patient’s baseline portal hypertension. ii) There was an important drug effect of belapectin in the total patient population on liver biopsy with a statistically significant improvement in hepatocyte ballooning (ie cell death), (iii) There was a shorter, single site, four-month trialstatistically significant reduction (p=0.02) in 30 NASHthe development of new esophageal varices in drug-treated patients with advanced fibrosis, but not cirrhosis, randomized 1:1compared to either 9bi-weekly doses ofplacebo. We believe that this is a clinically relevant endpoint related to patient outcomes, (iv) While there was a drug effect in both the 2 mg/kg LBM and 8 mg/kg LBM groups on the development ofGR-MD-02 or placebo. The trial did not meet its primary biomarker endpoint as measured using multi-parametric magnetic resonance imaging (LiverMultiScan(R), Perspectum Diagnostics). The trial also did not meet secondary endpoints that measure varices and liver stiffness asbiopsy there was a surrogate for fibrosis using, magnetic resonance-elastographyconsistently greater and FibroScan score. After analysisstatistically significant effect of the data, we do not believe that a four-month treatment period was likely long enough in the NASH population to show efficacy results. This small study was not powered for the secondary endpoints and thus, not surprisingly did not meet the secondary endpoints. In the trial,GR-MD-02 was found2 mg/kg LBM dose of belapectin, (v) belapectin appears to be safe and well tolerated amongin this one year clinical trial, a feature that is of prime importance for a cirrhotic population and (vi) We believe this is the patient population with no serious adverse events.

Although there was no apparentfirst large, randomized clinical trial to demonstrate a clinically meaningful improvement in portal hypertension or liver biopsy in patients with compensated NASH cirrhosis who have not yet developed esophageal varices.

Further information and details on the
NASH-CX
results summarized above is available in public presentations posted to our website and filed with the threenon-invasive tests SEC and in a peer reviewed publication in
Gastroenterology
(Gastroenterology 2020;158:1334–1345).
NASH NAVIGATE Trial:
Building on the experience of the
NASH-CX
trial, the NAVIGATE Trial is a seamless adaptively-designed Phase 2b/3 clinical study evaluating the safety and efficacy of our
galectin-3
inhibitor, belapectin
(GR-MD-02),
for assessmentthe prevention of esophageal varices in patient with
non-alcoholic
steatohepatitis (NASH) cirrhosis. The major features of this innovative Phase 2b/3 study design are: i) In patients with NASH cirrhosis and clinical signs of portal hypertension but without esophageal varices at baseline, this trial will assess the effect of belapectin on the incidence of new varices (the primary endpoint) – as well as assessing effect on the incidence of long-term, clinically significant cirrhosis-related outcomes (a key secondary efficacy endpoint), (ii) The study targets NASH patients with a clearly identified unmet medical need: patients with compensated cirrhosis who are at risk of developing esophageal varices, a potentially life-threatening complication of cirrhosis (bleeding varices are a cause of death in about
one-third
of cirrhotic patients). There is no approved treatment for preventing varices in these patients. In addition, the development of esophageal varices reflects the progression of hepatic cirrhosis and thus portends the development of other cirrhosis complications such as ascites, hepatic encephalopathy, and liver fibrosisfailure, and (iii) During the first 18 months, two belapectin dose levels (2 mg/kg LBM and 4 mg/kg LBM) will be compared to placebo (phase 2b). Then, at the interim analysis (IA), one belapectin dose will be selected based on efficacy and safety, for continued evaluation (Phase 3). The belapectin dose selected for the phase 2b/3 are based on the analysis of the
NASH-CX
trial, including a dose response pharmacokinetic analysis of the hepatic venous gradient pressure (HVPG, a reflection of portal hypertension). Prior belapectin clinical studies have also indicated the good tolerance and safety profile of belapectin with doses of up to 8 mg/kg LBM for 52 weeks (Phase 2b Study
NASH-CX),
an important feature of the future risk benefit analysis in patients with NASH cirrhosis.
The study design provides for a
pre-specified
interim analysis (IA). The IA of efficacy and safety data will be conducted after all planned subjects in Phase 2b component have completed at least 78 weeks (18 months) of treatment and an esophago-gastro-duodeno endoscopic assessment. The purpose of the IA is to allow potential seamless adaptive modifications of the study, including: (1) the selection of the optimal dose of belapectin for Phase 3, (2) the
re-estimation
of the study sample size for Phase 3 portion of the trial, (3) the
re-evaluation
of the randomization ratio for the Phase 3 portion of the trial, (4) the refinement of the inclusion and exclusion criteria for the Phase 3 portion of the trial, including the cirrhosis status, (5) and/or termination of the study for overwhelming efficacy or for futility.
The trial design also includes a blinded sample size
re-estimation
(“SSR”) during the Phase 2b, prior to the IA, to allow for potential sample size readjustment. The SSR will be conducted when 50% of the patients have completed 18 months of therapy. This will allow us to confirm the underlying assumption regarding the rate of varices development, currently estimated from our prior Phase 2b trial
(NASH-CX).
The study design also minimizes invasive testing requirements, such as the measurement of HVPG or repeated liver biopsies, which we believe will facilitate enrollment and retention of patients. It also provides for a seamless transition of patients from the Phase 2b component into the phase 3 stage, including the potential addition of new patients. The trial design preserves the surrogate
end-point
concepts (development of new varices versus variceal hemorrhage) previously discussed with FDA.
We believe that these adaptations taken together are innovative and optimize conduct of the NAVIGATE trial with a clinically relevant primary outcome giving belapectin the best opportunity to show a positive therapeutic effect to address an unmet medical need. If the IA results of the NAVIGATE trial are compelling, there could be the potential for accelerated FDA approval and/or partnership opportunity with a pharmaceutical company.
In the Phase 3 component of this trial, as proposed in the four-monthNASH-FX trial,protocol, the principal investigatorprimary endpoint remain the development of theNASH-FX trial has stated that the inhibitionvarices. Secondary endpoints include a composite clinical outcomes endpoint, including varices requiring treatment (development ofgalectin-3 large varices or varices withGR-MD-02 remains promising for the treatment a red wale), decompensating events,
all-cause
mortality, MELD score increase, liver transplant. Also, NASH
non-invasive
biomarkers will be evaluated. To target a population at risk of NASH fibrosis. Of note is thatGR-MD-02 has demonstrateddeveloping esophageal varices, patient selection will be based on clinical signs of portal hypertension, including, a low platelet count, an improved clinical effect inmoderate-to-severe psoriasis and inmoderate-to-severe atopic dermatitis patients, suggesting the compound has activity in an immune-mediated inflammatory human disease that can occur in association with NASH and in whichgalectin-3 is believed to play a role. We believe our drug candidate provides a promising new approach for the therapyincreased spleen size and/or evidence of fibrotic diseases, and liver fibrosis in particular. Fibrosis is the formationcollaterals circulation.
19

Table of excess connective tissue (collagen and other proteins plus cellular elements such as myofibroblasts) in response to damage, inflammation or repair. When the fibrotic tissue becomes confluent, it obliterates the cellular architecture, leading to scarring and dysfunction of the underlying organ. Givengalectin-3’s broad biological functionality, it has been demonstrated to be involved in cancer, inflammation and fibrosis, heart disease, and renal disease. We have further demonstrated the broad applicability of the actions of ourgalectin-3 inhibitor’s biological effect in ameliorating fibrosis involving lung, kidney, blood vessels, and cardiac tissues in a variety of animal models.

Contents

The focus and goal of the therapeutic program is to stop the progression of andand/or reverse the fibrosis in the liverportal hypertension and thereby improve liver function and prevent the development of complicationsvarices, potentially one of fibrosis/the most immediately life-threatening complication of cirrhosis. Based on the results of the
NASH-CX
trial and subject to confirmation in later stage clinical trials, we believe that this goal is achievable in a significant portion of the NASH cirrhosis patient population i.e. those NASH cirrhosis patients with clinical signs of portal hypertension.
The
COVID-19
pandemic has delayed and may continue to delay our recruitment of sites and enrollment of patients for our Phase 2b/3 NAVIGATE trial. While there has been a large decline in cases and hospitalizations in the United States because of vaccinations, the decline in the rate of vaccinations and the emergence of variants has extended the pandemic within the United States and has caused continued concern particularly in medical and hospital settings. While many cities in the United States and Europe had loosened restrictions, many of those restrictions are being
re-imposed.
In some countries, shutdown orders have also affected the regulatory process to authorize study starts. Governments and medical facilities continue to focus their resources for battling the
COVID-19
pandemic. For several reasons, the pandemic makes enrolling patients for the NAVIGATE trial more challenging, including because patients eligible for the NAVIGATE trial have liver cirrhosis and, liver-related mortality as such, are at a greater health risk of complications from
COVID-19.
Even with vaccinations being more readily available, we continue to be impacted by
COVID-19.
We believe that as more people get vaccinated for
COVID-19
in the United States and in other countries, site recruitment and patient enrollment will accelerate. At this time, we estimate that enrollment completion will occur around the end of 2021.
We have identified more than 130 clinical trial sites in 11 countries for the NAVIGATE trial.
Further details on the NAVIGATE trial can be found on
www.clinicaltrials.gov
under study NCT04365868.
The Company also has commenced a Hepatic Impairment Study, which will run in parallel with the phase 2b/3 trial as part of the development program. The Hepatic Impairment Study is being conducted at three sites and will involve approximately 40 patients (divided amongst normal healthy volunteers, and patients with hepatic impairment categorized as Child-Turcotte-Pugh (CTP) classes A (mild), B (moderate), and C (severe)). Each subject will receive a single infusion of belapectin (4 mg/kg LBM) and their serum belapectin levels will be monitored for up to approximately two weeks to define the effects of various stages of cirrhosis on serum belapectin levels. The tolerance and safety of belapectin will be evaluated. Based on the results from this hepatic impairment study, the Company may consider including patients with more advanced cirrhosis in the Phase 3 portion of its NAVIGATE trial. Until dosing and safety profile is further informed in CTP Class B and/or Class C patients, the NAVIGATE trial will enroll only CTP Class A patients.

Further details on this hepatic impairment study can be found on

www.clinicaltrials.gov
study NCT04332432.
Cancer Immunotherapy.
We believe there is potential for galectin inhibition to play a key role in the burgeoning area of cancer immunotherapy. For example, there have been several recent approvals of drugs that enhance a patient’s immune system to fight cancer. It is our goal to use a galectin inhibitor to further enhance the immune system function to fight cancer in a way that complements other approaches to this type of therapy. This hypothesis is supported by the fact that
galectin-3
is expressed at high levels in multiple types of tumors, adds to the malignant nature of the tumors, and protects the tumors from immune system attack. Our drug candidates provide a promising new therapeutic approach to enhance the activity of the immune system against cancer cells. Preclinical studies have indicated thatGR-MD-02 belapectin enhances the immune response to cancer cells, increased tumor shrinkage and enhanced survival in immune competent mice with prostate, breast, melanoma and sarcoma cancers when combined with one of the immune checkpoint inhibitors,
anti-CTLA-4
or
anti-PD-1, and
or with the immune cell activator anti-OX40. These preclinical data led to the filing of two Investigator-sponsored INDs and the initiation of studies ofGR-MD-02 belapectin in combination with Yervoy
®
(ipilimumab) and KEYTRUDA (pembrolizumab) in Phase 1B studies of patients with metastatic melanoma. The KEYTRUDA trial has also been expanded to include patients with
non-small
cell lung cancer and head and neck squamous cell carcinoma. These studies are being conducted under the sponsorship of Providence Portland Medical Center’s Earle A. Chiles Research Institute (EACRI).

Data on this combination immunotherapy program was presented on February 7, 2017 at the 9th GTCBio Immunotherapeutics & Immunomonitoring Conference in San Diego, CA by Dr. William L. Redmond, Providence Cancer Center. Preclinical results in mouse models of multiple types of cancers showed important anti-tumor and increased survival effects of combiningGR-MD-02 with different types of immune modulators, providing a case for progressing studies into human patients with cancer. Seven patients were treated in theGR-MD-02 in combination with Yervoy trial, with no safety concerns in these low dose cohorts. Due to changes in the standard of care for metastatic melanoma (i.e., approval ofanti-PD-1), recruitment has been slowed significantly in this trial.

Promising results were reported in the Phase 1b trial combiningGR-MD-02 belapectin with pembrolizumab (KEYTRUDA)(KEYTRUDA
®
). Cohort 1 was completed (n=6, 5 with melanoma, one with head and neck)neck cancer) with one partial response and one mixed response in 5the melanoma patients. There was a rapid and marked tumor response after 3 doses of combinedGR-MD-02 belapectin and pembrolizumab in the one partial response patient who had failed high-dose
IL-2
and oncolytic virus + ipilimumab. This Phase 1b clinical trial that combinesGR-MD-02 with pembrolizumab (KEYTRUDA®) continues to enroll patients and recently completed the second cohort, which used 4 mg/kgGR-MD-02. The third cohort, which will start 85 days following the final patient enrollment in the second cohort, will enroll 10 patients at a dose of 8 mg/kgGR-MD-02. There will likely be additional data reported in early 2018. The study is ongoing and progression to further development will be based on response rate as compared to historical response rates to pembrolizumab alone.

Severe skin diseases.

Psorasis. During our Phase 1 NASH fibrosis trial In September 2018 we announced additional preliminary clinical data from cohort 3 of this investigator-initiated trial. When aggregated withGR-MD-02, cohorts previously reported, the data shows a clinical effect on plaque psoriasis was observed50% objective response rate in advanced melanoma with belapectin in combination with KEYTRUDA, and a NASH patient who also had this disease. This patient had marked improvementsignificant decrease in her psoriasis, with improvement beginning after the third infusion. She reported that her psoriasis was “completely gone”frequency of suppressive myeloid-derived suppressor cells following treatment in the responding patients (on day 85 post-treatment). Fourteen advanced melanoma patients across three dose cohorts now have Objective Response Rate (ORR) and her skin was “normal” after the fourth infusion. Her skin remained normal for 17 months after the final infusion of study drug. The patient is convinced that the improvementDisease Control Rate (DCR) data. Six patients completed in her psoriasis is relatedcohort 3 (8 mg/kg LBM) have now been added to the study drug.

This serendipitous finding, combined withgalectin-3 protein being markedly upregulatedthree patients completed in the capillary epithelia (small blood vessels)cohort 2 (4 mg/kg LBM) and five patients completed in cohort 1 (2 mg/kg LBM). Cohorts 1 and 3

20

Table of the psoriatic dermis (plaque lesions), led to a phase 2a trial inContents
each had two patients with moderate to severe plaque psoriasis.GR-MD-02 inhibition ofgalectin-3 may attenuate capillary changes in the psoriatic dermis and inflammatory recruitment, perhaps explaining the improvements observed in the NASH fibrosis trial patient. In this open-label, unblinded trial (no placebo, all patients knowingly receive active drug), 5 patients with moderate to severe plaque psoriasis were administeredGR-MD-02 every two weeks for 24 weeks. In May 2016, we reported positive results on the first four patients after 12 weeks of therapy. Based on these results, we modified the trial to include 24 weeks of therapy. In August 2016, we reported on four patients after 24 weeks of therapy and one patient after 12 weeks of therapy. The four patients who received 24 weeks of therapy experienced an average of 48% improvement in their plaque psoriasis. At this time, the average response in all five patients remains at 50% with one patient having an 82% improvement. However, there are existing drugs on the market in this disease that produce 75% and higher improvements in60-90% of patients. While we are encouraged that this study has demonstrated clinically meaningful results in a human disease withGR-MD-02, the next steps would entail a controlled, does-ranging clinical trial which we do not expect to conduct absent a strategic partnership. The results of this Phase 2a clinical trial was presented at the Maui Derm for Dermatologists meeting in March 2017. The results have been published in the Journal of the American Academy of Dermatology in October 2017.

Atopic Dermatitis. Atopic Dermatitis (AD) is a chronic pruritic (itching), immune-mediated, inflammatory skin disease that for some adult patients can be severe and debilitating. There is an important unmet medical need in adults with severe disease who are not adequately treated with topical medicines. Our findings in psoriasis led to an interest in exploring the potential utility of the compound in treatment of AD. A Phase 2a open label trial was initiated in 3 adult patients who were treated withGR-MD-02 at 8 mg/Kg every other week for 12 weeks, and dosage could be increased to 12 mg/Kg for weeks12-24 if an incomplete response was observed. The response was objectively evaluated using two validated scores: the EASI (eczema area and severity index) and SCORAD (severity scoring of atopic dermatitis index).objective response. All three patients showed clinical responsesin cohort 2 had an objective response. In addition to the fourteen advanced melanoma patients, six patients with head and neck cancer were enrolled in this trial with a 33% ORR and 67% DCR. These data, taken together with the observed favorable safety and tolerability of the combination, in the view of the principal investigator, provide compelling rationale to move forward. Given that all three melanoma patients were responders at the 4 mg/kg dose, the investigators plan to continue the trial with the expansion of the 4 mg/Kg cohort to include additional advanced melanoma patients and additional head and neck cancer patients.

The expansion cohort enrolled nine melanoma patients and five head and neck squamous cell carcinoma cancer patients. Compared to the initial phase 1b patients, reported earlier, the cohort in this extension study was heavily pretreated with systemic therapy, including chemotherapy, immunotherapy with checkpoint inhibitors and cytokines, melanoma mutation-directed therapies (BRAF inhibitors and MEK inhibitors), as determined by reductionwell as surgery and radiation therapies (external and radio-labeled). Patients also had a high burden of EASImetastasis, with the lungs, soft tissues, and SCORAD during the study. but no subject achievedliver being the most frequently involved organs. Four of the nine melanoma patients had a choroidal (ocular) tumor as a primary endpoint. Upon completionsite of the24-weektheir cancer and had also developed liver metastasis. The treatment phase subjectconsisted of Belapectin 4 mg/Kg of lean body mass administered every three weeks by infusion, after the infusion of pembrolizumab. Pembrolizumab was administered according to its label. Patients’ response was evaluated at day 85, according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The median number of treatment cycles was four (range
3-15)
for melanoma patients and five (range
4-8)
for head and neck cancer patients. Melanoma patient results included one partial response, four stable disease, and four progressive disease, providing a disease control rate of 56% (five out of nine patients). Head and neck cancer patients observed included two stable disease and three progressive disease, providing a disease control rate of 40% (two out of five patients). The combination of Belapectin and pembrolizumab was well tolerated and appeared safe. The most frequent adverse event related to pembrolizumab, in six patients, was grade 1 met both secondary endpoints(mild) pruritus (itching), a known and labeled side-effect ofSCORAD-50 andEASI-50, and subject pembrolizumab. The second most frequent adverse event related to pembrolizumab was grade 2 met one secondary endpoint(EASI-50)fatigue in three patients. All other adverse events were mild (grade 1). Subject 3 approached a secondary endpoint with an EASI reduction of 49% at week 24. There were no druggrade 3 or above adverse events. Similar to the initial phase 1 study results, the frequency and severity of toxicities related to pembrolizumab, notably immune-mediated adverse events, during this trial. These initial findingswas less than anticipated. No adverse event was deemed related to belapectin.
Discussions are believed to suggestongoing about the planning and feasibility of a clinically relevant effect. Additionally, the 12 mg/Kg dosage was administered safely in this patient population.

We believe the mechanism of action forGR-MD-02 in moderate to severe skin diseases is based upon interaction with, and inhibition of, galectin proteins, particularlygalectin-3, which are expressed at high levels in certain pathological states including inflammation, fibrosis, skin diseases and cancer. WhileGR-MD-02 is capable of binding to multiple galectin proteins, we believe that it has the greatest affinity forgalectin-3, the most prominent galectin implicated in pathological processes. Blocking galectin in cancer and liver fibrosis has specific salutary effects on the disease process.

multicenter Phase 2 study.

Results of Operations

Three and NineSix Months Ended SeptemberJune 30, 20172021 Compared to Three and Six Months Ended SeptemberJune 30, 2016

2020

Research and Development Expense.

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
   2017 as Compared to 2016 
       Three Months  Nine Months 
   2017   2016   2017   2016   $ Change   % Change  $ Change  % Change 
   (In thousands, except %) 

Research and development

  $3,503   $3,289   $10,719   $11,892   $214    7 $(1,173  (10%) 

   Three Months Ended   Six Months Ended   2021 as Compared to 2020 
   June 30,   June 30,   Three Months  Six Months 
   2021   2020   2021   2020   $ Change  % Change  $ Change   % Change 
   (In thousands, except %) 
Research and development
  $6,450   $4,681   $11,349   $6,825   $1,769   38 $4,524    66
We generally categorize research and development expenses as either direct external expenses, comprised of amounts paid to third party vendors for services, or all other research and development expenses, comprised of employee payroll and general overhead allocable to research and development. We consider a clinical program to have begun upon acceptance by the FDA, or similar agency outside of the United States, to commence a clinical trial in humans, at which time we begin tracking expenditures by the product candidate. Clinical program expenses comprise payments to vendors related to preparation for, and conduct of, all phases of the clinical trial, including costs for drug manufacture, patient dosing and monitoring, data collection and management, oversight of the trials and reports of results.
Pre-clinical
expenses comprise all research and development amounts incurred before human trials begin, including payments to vendors for services related to product experiments and discovery, toxicology, pharmacology, metabolism and efficacy studies, as well as manufacturing process development for a drug candidate.

We have two product candidates,GR-MD-02 andGM-CT-01; however onlyGR-MD-02 is in active development. We filed for an IND forGR-MD-02 in January 2013 and in February 2013 we entered into an agreement with CTI to conduct a Phase 1 clinical trial

21

Table ofGR-MD-02. In March 2013, the FDA indicated we could proceed with a Phase 1 human clinical trial ofGR-MD-02, and we began enrolling patients in the third quarter of 2013. In January 2014, we completed the enrollment of the first cohort of patients in the Phase 1 trial with no serious adverse events being reported. We reported initial safety and tolerability results from the first cohort of patients on March 31, 2014. The second cohort of this Phase 1 trial began and enrollment was completed in April 2014. In July 2014, we reported the results from the second cohort of patients. Enrollment of the third cohort of Phase 1 began in July 2014 with interim results presented in November 2014 with the final report on cohort 3 presented in January 2015. The results of the Phase 1 study demonstrate that(i) GR-MD-02 was safe and well tolerated by patients with advanced NASH liver fibrosis after IV administration of four doses of 2 mg/kg, 4 mg/kg and 8mg/kg lean body weight, (ii) Pharmacokinetics revealed drug exposure in humans at the 8 mg/kg dose that was equivalent to the upper range of the targeted therapeutic dose determined from effective doses in NASH animal models, (iii) Disease Serum Marker Effect showed there was a statistically significant, dose-dependent reduction in FibroTest ® scores due to a statistically significant reduction inalpha-2 macroglobulin (A2M) serum levels, and (iv) Liver Stiffness Effect, as measured by FibroScan ® showed that there was a signal of reduced liver stiffness in patients receivingGR-MD-02. The reduction seen in A2M doesnot necessarily mean fibrosis got better in this short study, but does suggest changes in the fibrogenic process that might lead to an improvement in fibrosis with longer-term therapy. These Phase 1 results in NASH patients with advanced fibrosis provide a firm foundation for entry into a Phase 2 development program.

The Company held an “End of Phase 1 meeting” with the FDA and, amongst other things, received guidance on the primary endpoints for a Phase 2 trial. Our Phase 2 program in fibrotic disease consists of two separate human clinical trials. The first clinical trial is the Phase 2bNASH-CX study for patients with NASH with cirrhosis, which began enrolling in June 2015. This study is the primary focus of our program and is a randomized, placebo-controlled, double-blind, parallel-group Phase 2 trial to evaluate the safety and efficacy ofGR-MD-02 for the treatment of liver fibrosis and resultant portal hypertension in patients with NASH cirrhosis. Enrollment in this trial was completed in September 2016, and a total of 162 patients at 36 sites in the United States were be randomized to receive either 2 mg/kg ofGR-MD-02, 8 mg/kg ofGR-MD-02 or placebo, with approximately 54 patients in each group. The primary endpoint is a reduction in change in hepatic venous pressure gradient (HVPG). Patients are receiving an infusion every other week for one year, total of 26 infusions, and will be evaluated to determine the change in HVPG as compared with placebo. HVPG will be correlated with secondary endpoints of fibrosis on liver biopsy as well as with measurement of liver stiffness (FibroScan(R)) and assessment of liver metabolism (13C-methacetin breath test, Exalenz), which arenon-invasive measures of the liver that may be used in future studies. Data readout is expected in early December 2017.

The second trial, our Phase 2a pilot trialNASH-FX for patients with NASH advanced fibrosis which explored use of threenon-invasive imaging technologies, is now complete. It was a shorter, four-month trial in 30 NASH patients with advanced fibrosis, but not cirrhosis, randomized 1:1 to either 9bi-weekly doses of 8 mg/kg ofGR-MD-02 or placebo. The trial did not meet its primary biomarker endpoint as measured using multi-parametric magnetic resonance imaging (LiverMultiScan(R), Perspectum Diagnostics). The trial also did not meet secondary endpoints that measure liver stiffness as a surrogate for fibrosis using, magnetic resonance-elastography and FibroScan score. After analysis of the data, we do not believe that a four-month treatment period was likely long enough in the NASH population to show efficacy results. This small study was not powered for the secondary endpoints and thus, not surprisingly did not meet the secondary endpoints. In the trial,GR-MD-02 was found to be safe and well tolerated among the patient population with no serious adverse events.

Although there was no apparent improvement in the threenon-invasive tests for assessment of liver fibrosis in the four-monthNASH-FX trial, the principal investigator of theNASH-FX trial has stated that the inhibition ofgalectin-3 withGR-MD-02 remains promising for the treatment of NASH fibrosis. Of note is thatGR-MD-02 has demonstrated an improved clinical effect inmoderate-to-severe psoriasis, suggesting the compound has activity in a human disease that can occur in association with NASH. We believe our drug candidate provides a promising new approach for the therapy of fibrotic diseases, and liver fibrosis in particular. Fibrosis is the formation of excess connective tissue (collagen and other proteins plus cellular elements such as myofibroblasts) in response to damage, inflammation or repair. When the fibrotic tissue becomes confluent, it obliterates the cellular architecture, leading to scarring and dysfunction of the underlying organ. Givengalectin-3’s broad biological functionality, it has been demonstrated to be involved in cancer, inflammation and fibrosis, heart disease, renal disease and stroke. We have further demonstrated the broad applicability of the actions of ourgalectin-3 inhibitor’s biological effect in ameliorating fibrosis involving lung, kidney and cardiac tissues in a variety of animal models.

The focus and goal of the therapeutic program is to stop the progression of and reverse the fibrosis in the liver and, thereby improve liver function and prevent the development of complications of fibrosis/cirrhosis and liver-related mortality in patients.

Additionally, during the Phase 1 clinical trial, there appeared to be a potential beneficial effect on at least one patient’s moderate to severe psoriasis. This serendipitous finding, combined withgalectin-3 protein being markedly upregulated in the capillary epithelia (small blood vessels) of the psoriatic dermis (plaque lesions), led to a phase 2a trial in patients with moderate to severe plaque psoriasis.GR-MD-02 inhibition ofgalectin-3 may attenuate capillary changes in the psoriatic dermis and inflammatory recruitment, perhaps explaining the improvements observed in the NASH fibrosis trial patient. In this open-label, unblinded trial (no placebo, all patients knowingly receive active drug), 4 patients with moderate to severe plaque psoriasis were administeredGR-MD-02 every two weeks for 12 weeks. In May 2016, we reported positive results on the first four patients after 12 weeks of therapy. Based on these results, we modified the trial to include 24 weeks of therapy. In August 2016, we reported on four patients after 24 weeks of therapy and one patient after 12 weeks of therapy. The four patients who received 24 weeks of therapy experienced an average of 48% improvement in their plaque psoriasis. However, there are existing drugs on the market in this disease that produce 75% and higher improvements. While we are encouraged that this study has demonstrated clinically meaningful results in a human disease withGR-MD-02, we do not expect to conduct further trials in this area absent a strategic partnership.

An open label drug-drug interaction study was completed withGR-MD-02 and it showed that with 8 mg/kg dose ofGR-MD-02 and 2 mg/kg dose of midazolam there was no drug-drug interaction and no serious adverse events or drug-related adverse events were observed. This study was required by the FDA and the primary objective was to determine if single or multiple intravenous (IV) doses ofGR-MD-02 affect the pharmacokinetics (PK) of midazolam. The secondary objective was to assess the safety and tolerability ofGR-MD-02 when administered concomitantly with midazolam. The lack of a drug interaction in this study enables Galectin to expand the number of patients eligible for its Phase 2 clinical trial. In addition, shouldGR-MD-02 be approved for marketing, the success of this study supports a broader patient population for the drug label.

Based on guidance from FDA and in furtherance of its understanding of theGR-MD-02 molecule, we continue to enhance its chemistry, manufacturing and control procedures onGR-MD-02 active pharmaceutical ingredient (API) as well as on the finished, sterile, pharmaceutical dosage form. Various state of the art and cutting-edge analytical technologies are being utilized, for example, to characterize and quantify the backbone vs. side-chain constituents and their quantitation, use of sophisticated linkage analysis with2-D NMR to provide both qualitative and quantitative information on the proportion of oligomers, degree of methylation, as well as other monoclonal specific antibody techniques to map GR oligomer integrity and distribution. The Company has also characterized how the GR molecule behaves under conditions of forced degradation.

Contents

Our research and development expenses were as follows:

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2017   2016   2017   2016 
   (in thousands) 

Direct external expenses:

  

Clinical programs

  $2,945   $2,499   $8,973   $9,272 

Pre-clinical activities

   39    213    105    787 

All other research and development expenses

   519    577    1,641    1,833 
  

 

 

   

 

 

   

 

 

   

 

 

 
  $3,503   $3,289   $10,719   $11,892 
  

 

 

   

 

 

   

 

 

   

 

 

 

   Three Months Ended
June 30,
   Six Months Ended
June 30,
 
   2021   2020   2021   2020 
   (in thousands) 
Direct external expenses:
     
Clinical programs
  $5,878   $3,779   $10,161   $4,798 
Pre-clinical
activities
   70    121    181    363 
All other research and development expenses
   502    781    1,007    1,664 
   
 
 
   
 
 
   
 
 
   
 
 
 
   $6,450   $4,681   $11,349   $6,825 
Clinical programs expenses increased primarily due to costs related to our NAVIGATE trial during the three and six months ended SeptemberJune 30, 2017 as compared to the prior year and decreased during nine months ended September 30, 2017 as compared to the same period in 2016 primarily due to timing of costs incurred in theNASH-CX clinical trial. As we continue our Phase 2 trial, we expect our clinical activities costs will increase although they may fluctuate from quarter to quarter as the trials progress. Clinical activities expenses primarily decreased due to reduced expenses associated with drug manufacturing and preparation.Pre-clinical activities decreased primarily because we have completedpre-clinical work directly related to our Phase 2 clinical trial program. Other research and development expense decreased in the nine months ended September 30, 2017 compared to 2016 primarily due to a decrease innon-cash stock-based compensation expense of approximately $191,000.

2021.

Both the time required and costs we may incur in order to commercialize a drug candidate that would result in material net cash inflow are subject to numerous variables, and therefore we are unable at this stage of our development to forecast useful estimates. Variables that make estimates difficult include the number of clinical trials we may undertake, the number of patients needed to participate in the clinical trial, patient recruitment uncertainties, trial results as to the safety and efficacy of our product, and uncertainties as to the regulatory agency response to our trial data prior to receipt of marketing approval. Moreover, the FDA or other regulatory agencies may suspend clinical trials if we or an agency believes patients in the trial are subject to unacceptable risks or find deficiencies in the conduct of the clinical trial. Delays or rejections may also occur if governmental regulation or policy changes during our clinical trials or in the course of review of our clinical data. Due to these uncertainties, accurate and meaningful estimates of the ultimate cost to bring a product to market, the timing of costs and completion of our program and the period during which material net cash inflows will commence are unavailable at this time.

General and Administrative Expense.

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
   2017 as Compared to 2016 
       Three Months  Nine Months 
   2017   2016   2017   2016   $ Change  % Change  $ Change  % Change 
   (In thousands, except %) 

General and administrative

  $911   $1,248   $3,155   $4,990   $(337  (27%)  $(1,835  (37)% 

                   2021 as Compared to 2020 
   Three Months
Ended June 30,
   Six Months
Ended June 30,
   Three Months  Six Months 
   2021   2020   2021   2020   $ Change   % Change  $ Change   % Change 
   (In thousands, except %) 
General and administrative
  $1,743   $1,421   $3,161   $2,861   $ 322    23 $300    10
General and administrative expenses consist primarily of salaries including stock basedstock-based compensation, legal and accounting fees, insurance, investor relations, business development and other office related expenses. The primary reasons for the decreaseincrease in general and administrative expenses for the three months ended SeptemberJune 30, 20172021 as compared to the same period in 20162020 are reduced legal expensesdue to increases in insurance expense of approximately $163,000$130,000, investor relations/business development expense of $209,000 and decreased
non-cash
stock based compensation expense of approximately $90,000.$181,000 partially offset by decrease in legal fees expense of $174,000. The primary reasons for the decreaseincrease in general and administrative expenses for the ninesix months ended SeptemberJune 30, 20172021 as compared to the same period in 2016 is2020 are due to recording of severance of $300,000, acceleration ofnon-cash, stock-based compensationincreases in insurance expense of $578,000 related to the termination$254,000, investor relations/business development expense of the Company’s executive chairman in January 2016, a decrease in investor relations expenses of approximately $335,000, a decrease in legal expenses of $248,000,$135,000 and a decrease in
non-cash
stock based compensation expense of $403,000.

$95,000 partially offset by decrease in legal fees expense of $192,000.

Liquidity and Capital Resources

Since our inception on July 10, 2000, we have financed our operations from proceeds of public and private offerings of debt and equity. As of SeptemberJune 30, 2017,2021, we raised a net total of $132$214.5 million from these offerings. We have operated at a loss since our inception and have had no significant revenues. We anticipate that losses will continue for the foreseeable future. At SeptemberJune 30, 2017, we2021, the Company had $7.0$31.6 million of unrestricted cash and cash equivalents available to fund future operations. We believe thatThe Company also has a $10 million unsecured line of credit facility with stockholder and director, Richard E. Uihlein. The Company has not drawn under the cash on hand at September 30, 2017,line of credit. The Company believes there is sufficient cash, including availability of the line of credit, to fund currently planned operations at least through February 2018 which creates uncertainty about the Company’s ability to continue as a going concern. Our abilitySeptember 30, 2022. We will require more cash to fund our operations after our current cash resources are exhausted depends on our abilitySeptember 30, 2022 and believe we will be able to obtain additional financing. The currently planned operations include costs related to our adaptively designed NAVIGATE Phase 2b/3 clinical trial. Currently, we expect to require an additional approximately
$30-$35 million
to cover costs of the trial to reach the planned interim analysis estimated to occur in the second half of 2023 along with drug manufacturing and other scientific support activities and general and administrative costs. However, there can be no assurance that we will be successful in obtaining such new financing or, achieve profitable operations, asif available, that such financing will be on terms favorable to which no assurances can be given. Accordingly, based on the forecasts and estimates underlying the Company’s current operating plan, substantial doubt exists about the ability for the Company to continue as a going concern. The financial statements do not currently include any adjustments that might be necessary if the Company is unable to continue as a going concern.

us.

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Net cash used in operations increased by $444,000$5,384,000 to $11,988,000$12,359,000 for the ninesix months ended SeptemberJune 30, 2017,2021, as compared to $11,544,000$6,975,000 for the ninesix months ended SeptemberJune 30, 2016.2020. Cash operating expenses increased principally just due to timing of payments for researchthe preparations and development activitiesexpenses related to our NAVIGATE clinical trial activity withGR-MD-02.

belapectin.

Net cash provided by financing activities for the ninesix months ended SeptemberJune 30, 20172021, of $16,815,000 represents proceeds of $10,000,000 from a convertible note payable, $2,951,000 from the exercise of common stock warrants and 2016, of $3,584,000 and $1,757,000, respectively, represents$3,864,000 in net proceeds from the saleissuance of common shares under our ATM. Net cash provided by financing activities for the six months ended June 30, 2020, of $263,000 represents proceeds of $219,000 from the exercise of common stock options and preferred stock and warrants.

Other.

We have engaged outside vendors for certain services associated with$44,000 in net proceeds from issuance of common shares under our clinical trials. These services are generally available from several providers and, accordingly, our arrangements are typically cancellable on 30 days notice.

ATM.

Off-Balance
Sheet Arrangements

We have not created, and are not a party to, any special-purpose or
off-balance
sheet entities for the purpose of raising capital, incurring debt or operating parts of our business that are not consolidated into our financial statements. We do not have any arrangements or relationships with entities that are not consolidated into our financial statements that are reasonably likely to materially affect our liquidity or the availability of capital resources.

Application of Critical Accounting Policies and Estimates

The preparation of condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate our estimates, including those related to intangible assets, accrued expenses, stock-based compensation, contingencies and litigation. We base our estimates on historical experience, terms of existing contracts, our observance of trends in the industry, information available from other outside sources and on various other factors that we believe to be appropriate under the circumstances. Actual results may differ from these estimates under different assumptions or conditions.

Critical accounting policies are those policies that affect our more significant judgments and estimates used in preparation of our consolidated financial statements. We believe our critical accounting policies include our policies regarding stock-based compensation, accrued expenses, derivatives and income taxes. For a more detailed discussion of our critical accounting policies, please refer to our 20162020 Annual Report on Form
10-K.

Item 3.Quantitative and Qualitative Disclosures about Market Risk

Item 3. Quantitative and Qualitative Disclosures about Market Risk
Market risk represents the risk of loss that may impact our financial position, operating results or cash flows due to changes in the U.S. interest rates. The primary objective of our investment activities is to preserve cash until it is required to fund operations. To minimize risk, we maintain our portfolio of cash and cash equivalents in operating bank accounts and money market funds. Since our investments are short-term in duration, we believe that we are not subject to any material market risk exposure.

Item 4.Controls and Procedures

Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of the Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule
13a-15(e)
promulgated under the Securities Exchange Act of 1934) and concluded that, as of SeptemberJune 30, 2017,2021, our disclosure controls and procedures were effective ateffective.
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a reasonablecontrol system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance level. that all control issues and instances of fraud, if any, within the Company have been detected.
Changes in Internal Control Over Financial Reporting
During the quarter ended SeptemberJune 30, 2017,2021, no change in our internal control over financial reporting has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II — OTHER INFORMATION

Item 1.Legal Proceedings

None except as discussed in Note 8 to our condensed consolidated financial statements included in this report.

Item 1. Legal Proceedings
None.
Item 1A.Risk Factors

Item 1A. Risk Factors
The information set forth in this report should be read in conjunction with the risk factors set forth in Item 1A, “Risk Factors,” of Part I of our Annual Report on Form
10-K
for the year ended December 31, 2016,2020, which could materially impact our business, financial condition or future results.

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

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None

Item 3.Defaults Upon Senior Securities

Item 3. Defaults Upon Senior Securities
None

Item 4.Mine Safety Disclosures

Item 4. Mine Safety Disclosures
Not Applicable

Item 5.Other Information

Item 5. Other Information
Not Applicable

Item 6. Exhibits
Item 6.Exhibits

Exhibit

Number

  

Description of Document

  

Note

Reference

 
  31.1*  Certification Pursuant to Rule13a-14(a) of the Securities Exchange Act of 1934  
  31.2*  Certification Pursuant to Rule13a-14(a) of the Securities Exchange Act of 1934  
  32.1**  Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of theSarbanes-Oxley Act of 2002  
  32.2**  
The following financial statements and footnotes from the Registrant’s Quarterly Report on Form
10-Q
for the fiscal quarter ended June 30, 2021 formatted in Inline Extensible Business Reporting Language (Inline XBRL):
  
101.INSInline XBRL Instance Document**
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101.INS
Exhibit
Number
  XBRL Instance Document*
Description of Document
  
Note
Reference
101.SCH  Inline XBRL Taxonomy Extension Schema Document*  
101.CAL  Inline XBRL Taxonomy Calculation Linkbase Document*  
101.DEF  Inline XBRL Taxonomy Extension Definition Linkbase Document*  
101.LAB  Inline XBRL Taxonomy Label Linkbase Document*  
101.PRE  Inline XBRL Taxonomy Presentation Linkbase Document*  
104Cover Page Interactive Data File (the cover page XBRL tags are embedded in the Inline XBRL document and included in Exhibit 101)*

*
Filed herewith.
**Furnished herewith and not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, on November 7, 2017.

August 16, 2021.
GALECTIN THERAPEUTICS INC.
By:
 
/s/ Peter G. TraberJoel Lewis
Name:
 Peter G. Traber, M.D.
Joel Lewis
Title:
 

Chief Executive Officer and President

(principal executive officer)

By:
 
/s/ Jack W. Callicutt
Name:
 
Jack W. Callicutt
Title:
 

Chief Financial Officer

(principal financial and accounting officer)

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