• |
The NAVIGATE Phase 2b/3 trial (NCT04365868) evaluating the efficacy and safety of belapectin for the prevention of esophageal varices in MASH cirrhosis completed randomization of 357 patients in 14 countries on five continents.
|
o |
The fourth Data Safety and Monitoring Board (DSMB) meeting authorized the continuation of the trial as designed and without modifications.
|
o |
Upcoming milestone remains on track for top-line data readout from NAVIGATE interim analysis in Q4 2024.
|
• |
Presented five posters at the Liver Meeting™ 2023 of the American Association for the Study of Liver Diseases (AASLD) including the safety profile of belapectin and the fact that its pharmacokinetics properties are not affected by the degree of liver impairment.
|
• |
Appointed Benjamin S. Carson, Sr., M.D. as a new member of the Board of Directors, following his service as a senior advisor to the Company since 2021.
|
• |
As of December 31, 2023, the Company had $25.7 million of cash and cash equivalents. Additionally, the Company has $20 million remaining available under a $60 million line of credit provided by its chairman to fund operations and a newly executed $10 million line of credit also provided by our chairman. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through March 31, 2025.
|
• |
Research and development expenses for the year ended December 31, 2023 were $32.1 million compared with $31.7 million for the year ended December 31, 2022. The increase was primarily due to costs related to our NAVIGATE clinical trial and other supportive activities.
|
• |
General and administrative expenses for the year ended December 31, 2023 were $5.9 million, compared to $6.6 million for the year ended December 31, 2022. The decrease was primarily due to non-cash stock-based compensation expense.
|
• |
For the year ended December 31, 2023, the Company reported a net loss applicable to common stockholders of $44.8 million, or ($0.74) per share, compared to a net loss applicable to common stockholders of $38.9 million, or ($0.65) per share for the year ended December 31, 2022. The increase is largely due to an increase in noncash interest expense of $1.8 million and a noncash charge related to modification of common stock purchase warrants of $3.6 million.
|
• |
These results are included in the Company's Annual Report on Form 10-K, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.
|
Year Ended
December 31,
| ||||||||
2023
|
2022
| |||||||
Operating expenses:
| ||||||||
Research and development
|
$
|
32,130
|
$
|
31,737
| ||||
General and administrative
|
5,942
|
6,615
| ||||||
Total operating expenses
|
38,072
|
38,352
| ||||||
Total operating loss
|
(38,072
|
)
|
(38,352
|
)
| ||||
Other income (expense):
| ||||||||
Interest income
|
230
|
52
| ||||||
Interest expense
|
(2,792
|
)
|
(1,033
|
)
| ||||
Change in fair value of derivatives
|
(432
|
)
|
557
| |||||
Total other income
|
(2,994
|
)
|
(424
|
)
| ||||
Net loss
|
$
|
(41,066
|
)
|
$
|
(38,776
|
)
| ||
Preferred stock dividends
|
(120
|
)
|
(97
|
)
| ||||
Warrant modification
|
(3,619
|
)
| ||||||
Net loss applicable to common stock
|
$
|
(44,805
|
)
|
$
|
(38,873
| ) | ||
Basic and diluted net loss per share
|
$
|
(0.74
|
)
|
$
|
(0.65
|
)
| ||
Shares used in computing basic and diluted net loss per share
|
60,159
|
59,391
|
December 31, 2023
|
December 31, 2022
| |||||||
(in thousands)
| ||||||||
Cash and cash equivalents |
$
|
25,660
|
$
|
18,592
| ||||
Total assets
|
28,200
|
21,285
| ||||||
Total current liabilities
|
15,676
|
13,012
| ||||||
Total liabilities
|
88,441
|
53,479
| ||||||
Total redeemable, convertible preferred stock
|
1,723
|
1,723
| ||||||
Total stockholders' equity (deficit) |
$
|
(61,964
|
)
|
$
|
(33,917
|
)
|
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Disclaimer
Galectin Therapeutics Inc. published this content on 29 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 29 March 2024 11:58:08 UTC.