08/15/2022 | Press release | Distributed by Public on 08/15/2022 05:52
☒ |
Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
|
☐ |
Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
|
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)
|
Title of each class
|
Trading
Symbol(s)
|
Name of each exchange
on which registered
|
Common Stock
|
GALT
|
The Nasdaq Stock Market
|
Large Accelerated Filer
|
☐ |
Accelerated Filer
|
☐ |
Non-Accelerated Filer
|
☒ |
Smaller reporting company
|
☒ |
Emerging growth company
|
☐ |
PAGE
|
||
PART I - FINANCIAL INFORMATION
|
||
ITEM 1.
|
Unaudited Condensed Consolidated Financial Statements (unaudited)
|
|
|
Condensed Consolidated Balance Sheets as of June 30, 2022 and December 31, 2021 |
3
|
|
Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2022 and 2021 |
4
|
|
Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2022 and 2021 |
5
|
|
Condensed Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) for the Three and Six Months Ended June 30, 2022 and 2021 |
6
|
|
Notes to Unaudited Condensed Consolidated Financial Statements |
9
|
ITEM 2.
|
Management's Discussion and Analysis of Financial Condition and Results of Operations
|
17
|
ITEM 3.
|
Quantitative and Qualitative Disclosures about Market Risk
|
25 |
ITEM 4.
|
Controls and Procedures
|
25
|
PART II - OTHER INFORMATION
|
||
ITEM 1.
|
Legal Proceedings
|
26 |
ITEM 1A.
|
Risk Factors
|
26 |
ITEM 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
26 |
ITEM 3.
|
Defaults Upon Senior Securities
|
26 |
ITEM 4.
|
Mine Safety Disclosures
|
26 |
ITEM 5.
|
Other Information
|
26 |
ITEM 6.
|
Exhibits
|
26 |
SIGNATURES
|
28 |
June 30,
2022 |
December 31,
2021 |
|||||||
(in thousands)
|
||||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
24,178
|
$
|
39,648
|
||||
Prepaid expenses and other current assets
|
1,607
|
2,172
|
||||||
Total current assets
|
25,785
|
41,820
|
||||||
Other assets
|
101
|
7
|
||||||
Total assets
|
$
|
25,886
|
$
|
41,827
|
||||
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
2,964
|
$
|
1,805
|
||||
Accrued expenses and other
|
7,864
|
7,163
|
||||||
Accrued dividends payable
|
64
|
65
|
||||||
Total current liabilities
|
10,892
|
9,033
|
||||||
Convertible note payable and accrued interest, net of debt discount - related party (Note 3)
|
29,504
|
29,048
|
||||||
Derivative liability (Note 4) |
626
|
1,130
|
||||||
Other liabilities
|
87
|
-
|
||||||
Total liabilities
|
41,109
|
39,211
|
||||||
Commitments and contingencies (Note 9)
|
||||||||
Series C super dividend redeemable convertible preferred stock; 1,000shares authorized, 176shares issued and outstanding at June 30, 2022and December 31, 2021, redemption value: $8,388,000, liquidation value: $1,760,000at June 30, 2022
|
1,723
|
1,723
|
||||||
Stockholders' equity (deficit):
|
||||||||
Undesignated stock, $0.01par value; 20,000,000shares authorized, 20,000,000designated at June 30, 2022and December 31, 2021, respectively
|
-
|
-
|
||||||
Series A 12% convertible preferred stock; 1,742,500shares authorized, 1,260,000and 1,302,500issued and outstanding at June 30, 2022and December 31, 2021, respectively; liquidation value $1,260,000and $1,302,500at June 30, 2022and December 31, 2021, respectively
|
510
|
527
|
||||||
Common stock, $0.001par value; 150,000,000shares authorized at June 30, 2022and December 31, 2021, 59,395,805and 59,341,305issued and outstanding at June 30, 2022and December 31, 2021, respectively
|
59
|
59
|
||||||
Additional paid-in capital
|
272,772
|
271,001
|
||||||
Retained deficit
|
(290,287
|
)
|
(270,694
|
)
|
||||
Total stockholders' equity (deficit)
|
(16,946
|
)
|
893
|
|||||
Total liabilities, redeemable convertible preferred stock and stockholders' equity
|
$
|
25,886
|
$
|
41,827
|
Three Months Ended
June 30, |
Six Months Ended
June 30, |
|||||||||||||||
2022
|
2021
|
2022
|
2021
|
|||||||||||||
(in thousands, except per share data)
|
(in thousands, except per share data)
|
|||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
$
|
8,074
|
$
|
6,450
|
$
|
16,132
|
$
|
11,349
|
||||||||
General and administrative
|
1,588
|
1,743
|
3,465
|
3,161
|
||||||||||||
Total operating expenses
|
9,662
|
8,193
|
19,597
|
14,510
|
||||||||||||
Total operating loss
|
(9,662
|
)
|
(8,193
|
)
|
(19,597
|
)
|
(14,510
|
)
|
||||||||
Other income (expense):
|
||||||||||||||||
Interest income
|
3
|
1
|
4
|
2
|
||||||||||||
Interest expense
|
(229
|
)
|
(85
|
)
|
(456
|
)
|
(107
|
)
|
||||||||
Change in fair value of derivative
|
275
|
(172
|
)
|
504
|
(172
|
)
|
||||||||||
Total other income (expense)
|
49
|
(256
|
)
|
52
|
(277
|
)
|
||||||||||
Net loss
|
$
|
(9,613
|
)
|
$
|
(8,449
|
)
|
$
|
(19,545
|
)
|
$
|
(14,787
|
)
|
||||
Preferred stock dividends
|
(64
|
)
|
(65
|
)
|
(48
|
)
|
(67
|
)
|
||||||||
Net loss applicable to common stockholders
|
$
|
(9,677
|
)
|
$
|
(8,514
|
)
|
$
|
(19,593
|
)
|
$
|
(14,854
|
)
|
||||
Net loss per common share - basic and diluted
|
$
|
(0.16
|
)
|
$
|
(0.15
|
)
|
$
|
(0.33
|
)
|
$
|
(0.26
|
)
|
||||
Weighted average common shares outstanding - basic and diluted
|
59,389
|
58,312
|
59,372
|
57,725
|
Six Months Ended
June 30, |
||||||||
2022
|
2021
|
|||||||
(in thousands)
|
||||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net loss
|
$
|
(19,545
|
)
|
$
|
(14,787
|
)
|
||
Adjustments to reconcile net loss to net cash flows from operating activities:
|
||||||||
Stock-based compensation expense
|
1,505
|
835
|
||||||
Amortization of right to use lease asset
|
17
|
20
|
||||||
Non-cash interest expense
|
158
|
107
|
||||||
Change in fair value of derivative
|
(504
|
)
|
172
|
|||||
Changes in operating assets and liabilities:
|
||||||||
Prepaid expenses and other assets
|
454
|
587
|
||||||
Accounts payable, accrued expenses and other liabilities
|
2,147
|
666
|
||||||
Accrued interest on convertible notes payable - related party
|
298 | 41 | ||||||
Net cash flows from operating activities
|
(15,470
|
)
|
(12,359
|
)
|
||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Net proceeds from convertible note payable - related party
|
- | 10,000 | ||||||
Net proceeds from issuance of common stock
|
-
|
6,815
|
||||||
Net cash flows from financing activities
|
-
|
16,815
|
||||||
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
(15,470
|
)
|
4,456
|
|||||
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
39,648
|
27,142
|
||||||
CASH AND CASH EQUIVALENTS, END OF PERIOD
|
$
|
24,178
|
$
|
31,598
|
||||
NONCASH FINANCING ACTIVITIES:
|
||||||||
Payment of preferred stock dividends in common stock
|
$ |
49 |
$ |
67 | ||||
Fair value of derivative related to related party convertible note payable
|
- | 420 | ||||||
Reclassification of accrued bonus to additional paid in capital
|
|
200
|
|
60
|
||||
Noncash right to use lease asset
|
111
|
-
|
Series C Super
Dividend Redeemable Convertible Preferred Stock |
||||||||
Number of
Shares |
Amount
|
|||||||
Balance at December 31, 2020
|
176
|
$
|
1,723
|
|||||
Balance at June 30, 2021
|
176
|
$
|
1,723
|
|||||
Balance at December 31, 2021
|
176
|
$
|
1,723
|
|||||
Balance at June 30, 2022
|
176
|
$
|
1,723
|
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, 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
|
|||||||||||||||
Balance at March 31, 2022
|
1,302,500
|
$
|
527
|
59,388,518
|
$
|
59
|
$
|
272,108
|
$
|
(280,610
|
)
|
$
|
(7,916
|
)
|
||||||||||||||
Series A 12% convertible preferred stock dividend
|
|
(38
|
)
|
(38
|
)
|
|||||||||||||||||||||||
Series C super dividend redeemable convertible preferred
stock dividend |
|
(26
|
)
|
(26
|
)
|
|||||||||||||||||||||||
Issuance of common stock from conversion of Series A convertible preferred stock
|
(42,500 | ) | (17 | ) |
7,287
|
17 |
||||||||||||||||||||||
Stock-based compensation expense
|
647
|
647
|
||||||||||||||||||||||||||
Net loss
|
(9,613
|
)
|
(9,613
|
)
|
||||||||||||||||||||||||
Balance at June 30, 2022
|
1,260,000
|
$
|
510
|
59,395,805
|
$
|
59
|
$
|
272,772
|
$
|
(290,287
|
)
|
$
|
(16,946
|
)
|
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, 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
|
|||||||||||||||
Balance at December 31, 2021
|
1,302,500
|
$
|
527
|
59,341,305
|
$
|
59
|
$
|
271,001
|
$
|
(270,694
|
)
|
$
|
893
|
|||||||||||||||
Series A 12% convertible preferred stock dividend
|
13,025
|
20
|
(20
|
)
|
||||||||||||||||||||||||
Series C super dividend redeemable convertible preferred stock dividend
|
17,600
|
29
|
(28
|
)
|
1 | |||||||||||||||||||||||
Issuance of common stock from conversion of Series A convertible preferred stock
|
(42,500 | ) | (17 | ) |
7,287 |
17 |
||||||||||||||||||||||
Stock-based compensation expense
|
16,588
|
1,705
|
1,705
|
|||||||||||||||||||||||||
Net loss
|
(19,545
|
)
|
(19,545
|
)
|
||||||||||||||||||||||||
Balance at June 30, 2022
|
1,260,000
|
$
|
510
|
59,395,805
|
$
|
59
|
$
|
272,772
|
$
|
(290,287
|
)
|
$
|
(16,946
|
)
|
June 30,
2022 |
December 31,
2021 |
|||||||
(in thousands)
|
||||||||
Legal and accounting fees
|
$
|
100
|
$
|
68
|
||||
Accrued compensation
|
521
|
728
|
||||||
Lease liability
|
28
|
8
|
||||||
Accrued research and development costs and other
|
7,215
|
6,359
|
||||||
Total
|
$
|
7,864
|
$
|
7,163
|
|
Level 1
|
Level 2
|
Level 3
|
Total
|
||||||||||||
Derivative Liability - Contingent Interest April Note
|
$ | - | $ |
- |
$
|
276,000
|
$
|
276,000
|
||||||||
Derivative Liability - Contingent Interest September Note |
$ | - | $ | - |
$ |
131,000 |
$ |
131,000 | ||||||||
Derivative Liability - Contingent Interest December Note | $ | - | $ | - |
$ |
219,000 | $ | 219,000 |
June 30, | ||||||||
Inception
|
2022 |
|||||||
Stock Price
|
$
|
2.19
|
$
|
1.31
|
||||
Conversion Price of conversion feature
|
$
|
5.00
|
$
|
5.00
|
||||
Term
|
4 years
|
2.79 years
|
||||||
Risk Free Interest Rate
|
0.59
|
%
|
2.99
|
%
|
||||
Credit Adjusted Discount Rate
|
7.60
|
%
|
15.53
|
%
|
||||
Volatility
|
88
|
%
|
80
|
%
|
||||
Dividend Rate
|
0
|
% |
0
|
% |
Balance - December 31, 2020
|
$
|
-
|
||
Issuance of April convertible note payable - related party
|
420,000
|
|||
Fair Value Adjustment
|
75,000
|
|||
Balance - December 31, 2021
|
$
|
495,000
|
||
Fair Value Adjustment | (219,000 | ) | ||
Balance - June 30, 2022 | $ | 276,000 |
Inception |
June 30, 2022
|
|||||||
Stock Price
|
$
|
4.06
|
$
|
1.31
|
||||
Conversion Price of conversion feature
|
$
|
8.64
|
$
|
8.64
|
||||
Term
|
4 years
|
3.22years
|
||||||
Risk Free Interest Rate
|
0.68
|
%
|
2.99
|
%
|
||||
Credit Adjusted Discount Rate
|
7.59
|
%
|
15.53
|
%
|
||||
Volatility
|
91
|
%
|
88
|
%
|
||||
Dividend Rate
|
0
|
% |
0
|
% |
Balance - December 31, 2020
|
$ | - | ||
Issuance of September convertible note payable - related party
|
433,000 | |||
Fair Value Adjustment
|
(183,000 | ) | ||
Balance - December 31, 2021
|
$ | 250,000 | ||
Fair Value Adjustment | (119,000 | ) | ||
Balance - June 30, 2022 | $ | 131,000 |
June 30, | ||||||||
Inception
|
2022
|
|||||||
Stock Price
|
$
|
2.32
|
$
|
1.31
|
||||
Conversion Price of conversion feature
|
$
|
5.43
|
$
|
5.43
|
||||
Term
|
4 years |
3.48 years
|
||||||
Risk Free Interest Rate
|
1.04
|
%
|
2.99
|
%
|
||||
Credit Adjusted Discount Rate
|
8.54
|
%
|
15.53
|
%
|
||||
Volatility
|
86
|
%
|
87
|
%
|
||||
Dividend Rate
|
0
|
% |
0
|
% |
Balance - December 31, 2020
|
$
|
-
|
||
Issuance of September convertible note payable - related party
|
415,000
|
|||
Fair Value Adjustment
|
(30,000
|
)
|
||
Balance - December 31, 2021
|
$
|
385,000
|
||
Fair Value Adjustment
|
(166,000
|
)
|
||
Balance - June 30, 2022
|
$
|
219,000
|
Three Months Ended
June 30, |
Six Months Ended
June 30, |
|||||||||||||||
2022
|
2021
|
2022
|
2021
|
|||||||||||||
in thousands
|
||||||||||||||||
Research and development
|
$
|
154
|
$
|
89
|
$
|
379
|
$
|
156
|
||||||||
General and administrative
|
493
|
492
|
1,126
|
679
|
||||||||||||
Total stock-based compensation expense
|
$
|
647
|
$
|
581
|
$
|
1,505
|
$
|
835
|
Shares
|
Weighted Average
Exercise Price |
|||||||
Outstanding, December 31, 2021
|
4,895,561
|
$
|
3.14
|
|||||
Granted
|
945,000
|
1.84
|
||||||
Exercised
|
- |
-
|
||||||
Options forfeited/cancelled
|
(195,000
|
)
|
2.21
|
|||||
Outstanding, June 30, 2022
|
5,645,561
|
$
|
2.93
|
Six
Months Ended June 30, |
Six
Months Ended June 30, |
|||||||
2022
|
2021
|
|||||||
Risk-free interest rate
|
1.56
|
%
|
0.57
|
%
|
||||
Expected life of the options
|
5.6 years
|
6 years
|
||||||
Expected volatility of the underlying stock
|
94
|
%
|
91
|
%
|
||||
Expected dividend rate
|
0
|
% |
0
|
% |
Shares
|
Weighted Average
Exercise Price |
|||||||
Outstanding, December 31, 2021
|
10,857,964
|
$
|
4.37
|
|||||
Granted
|
-
|
-
|
||||||
Exercised
|
-
|
-
|
||||||
Forfeited/cancelled
|
-
|
-
|
||||||
Outstanding, June 30, 2022
|
10,857,964
|
$
|
4.37
|
June 30, 2022
(shares) |
June 30, 2021
(shares) |
|||||||
Warrants to purchase shares of common stock
|
10,857,964
|
11,357,964
|
||||||
Options to purchase shares of common stock
|
5,645,561
|
4,919,725
|
||||||
Shares of common stock issuable upon conversion of convertible note payable
|
5,515,161
|
2,049,428
|
||||||
Shares of common stock issuable upon conversion of preferred stock
|
503,340
|
510,424
|
||||||
22,522,026
|
18,837,541
|
2022
|
14
|
|||
2023
|
50
|
|||
2024 | 51 | |||
2025 | 18 | |||
Total
|
133
|
|||
Less imputed interest
|
18
|
|||
Present value of lease liability
|
$
|
115
|
Item 2.
|
Management's Discussion and Analysis of Financial Condition and Results of Operations
|
|
• |
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, 2021, and our subsequent SEC filings.
|
Indication
|
Drug
|
Status
|
Fibrosis
|
||
NASH with Advanced Fibrosis:
NASH-CX trial and
NASH-FX trial
|
belapectin
|
IND submitted January 2013. Results from the Phase 1 clinical trial were reported in 2014, with final results reported in January 2015.
The Phase 2 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
|
The Phase 2 NASH CX trial, was designed for patients with well compensated cirrhosis. The NASH CX trial top line data was reported in December 2017 and was published in Gastroenterologyin 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.
|
Cancer Immunotherapy
|
||
Melanoma, Head, Neck Squamous Cell
|
belapectin
|
Investigator IND study in process. A Phase 1B study began in Q-1 2016. Early data was
|
Carcinoma (HNSCC)
|
reported in February 2017 and additional data were reported in September 2018.
|
|
Data from an extension trial was reported in July 2021 for additional melanoma and
|
||
HNSCC patients which provided a rational basis for additional trials which the Company is
|
||
exploring.
|
Three Months Ended
|
Six Months Ended
|
2022 as Compared to 2021
|
||||||||||||||||||||||||||||||
June 30,
|
June 30,
|
Three Months
|
Six Months
|
|||||||||||||||||||||||||||||
2022
|
2021
|
2022
|
2021
|
$ Change
|
% Change
|
$ Change
|
% Change
|
|||||||||||||||||||||||||
(In thousands, except %)
|
||||||||||||||||||||||||||||||||
Research and development
|
$
|
8,074
|
$
|
6,450
|
$
|
16,132
|
$
|
11,349
|
$
|
1,624
|
25
|
%
|
$
|
4,783
|
42
|
%
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2022
|
2021
|
2022
|
2021
|
|||||||||||||
(in thousands)
|
||||||||||||||||
Direct external expenses:
|
||||||||||||||||
Clinical programs
|
$
|
6,791
|
$
|
5,878
|
$
|
13,660
|
$
|
10,161
|
||||||||
Pre-clinical activities
|
368
|
70
|
727
|
181
|
||||||||||||
All other research and development expenses
|
915
|
502
|
1,745
|
1,007
|
||||||||||||
$
|
8,074
|
$
|
6,450
|
$
|
16,132
|
$
|
11,349
|
2022 as Compared to 2021
|
||||||||||||||||||||||||||||||||
Three Months
Ended June 30,
|
Six Months
Ended June 30,
|
Three Months
|
Six Months
|
|||||||||||||||||||||||||||||
2022
|
2021
|
2022
|
2021
|
$ Change
|
% Change
|
$ Change
|
% Change
|
|||||||||||||||||||||||||
(In thousands, except %)
|
||||||||||||||||||||||||||||||||
General and administrative
|
$
|
1,588
|
$
|
1,743
|
$
|
3,465
|
$
|
3,161
|
$
|
(155
|
)
|
(9
|
)%
|
$
|
304
|
10
|
%
|
Item 3. |
Quantitative and Qualitative Disclosures about Market Risk
|
Item 4. |
Controls and Procedures
|
Item 1. |
Legal Proceedings
|
Item 1A. |
Risk Factors
|
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds
|
Item 3. |
Defaults Upon Senior Securities
|
Item 4. |
Mine Safety Disclosures
|
Item 5. |
Other Information
|
Item 6. |
Exhibits
|
Exhibit
Number
|
Description of Document
|
Note
Reference
|
31.1*
|
Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934
|
|
31.2*
|
Certification Pursuant to Rule 13a-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 the Sarbanes-Oxley Act of 2002
|
|
32.2**
|
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
The following financial statements and footnotes from the Registrant's Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2022 formatted in Inline Extensible Business Reporting Language (Inline XBRL): | ||
101.INS
|
Inline XBRL Instance Document**
|
Exhibit
Number
|
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**
|
|
104
|
Cover 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.
|
GALECTIN THERAPEUTICS INC.
|
||
By:
|
/s/ Joel Lewis
|
|
Name:
|
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)
|