☒ | 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 |
of Norcross, GANo.
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 (§232.05and post such files). Large Accelerated Filer ☐ Accelerated Filer ☐☒ ☐ (Do not check if a smaller reporting company) Smaller reporting company ☒ Emerging growth company ☐
57,077,055.
PAGE | |||||||||
PART I — FINANCIAL INFORMATION | |||||||||
ITEM 1. | Unaudited Condensed Consolidated Financial Statements (unaudited) | ||||||||
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4 | |||||||||
5 | |||||||||
6 | |||||||||
9 | |||||||||
ITEM 2. | 15 | ||||||||
ITEM 3. | 24 | ||||||||
ITEM 4. | 24 | ||||||||
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ITEM 1. | 25 | ||||||||
ITEM 1A. | 25 | ||||||||
ITEM 2. | 25 | ||||||||
ITEM 3. | 25 | ||||||||
ITEM 4. | 25 | ||||||||
ITEM 5. | 25 | ||||||||
ITEM 6. | 25 | ||||||||
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26 |
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 | ||||||
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Total current assets | 7,011 | 15,794 | ||||||
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Intangible assets, net | — | 1 | ||||||
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Total assets | $ | 7,011 | $ | 15,795 | ||||
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LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 166 | $ | 910 | ||||
Accrued expenses | 4,175 | 2,802 | ||||||
Accrued dividends payable | — | 68 | ||||||
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Total current liabilities | 4,341 | 3,780 | ||||||
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Total liabilities | 4,341 | 3,780 | ||||||
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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 | ) | ||||
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Total stockholders’ equity | 947 | 10,292 | ||||||
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Total liabilities, redeemable convertible preferred stock and stockholders’ equity | $ | 7,011 | $ | 15,795 | ||||
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September 30, 2020 | December 31, 2019 | |||||||
(in thousands) | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 32,556 | $ | 47,480 | ||||
Prepaid expenses and other current assets | 1,327 | 729 | ||||||
Total current assets | 33,883 | 48,209 | ||||||
Other assets | 166 | 258 | ||||||
Total assets | $ | 34,049 | $ | 48,467 | ||||
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 691 | $ | 1,661 | ||||
Accrued expenses and other | 1,797 | 1,093 | ||||||
Accrued dividends pay a ble | — | 66 | ||||||
Total current liabilities | 2,488 | 2,820 | ||||||
Other liabilities | 19 | 52 | ||||||
Total liabilities | 2,507 | 2,872 | ||||||
Commitments and contingencies (Note 10) | ||||||||
Series C super dividend redeemable convertible preferred stock; 1,000 shares authorized, 176 shares issued and outstanding at September 30, 2020 and December 31, 2019, redemption value: $8,520,000, liquidation value: $1,760,000 at September 30, 2020 | 1,723 | 1,723 | ||||||
Stockholders’ equity: | ||||||||
Undesignated stock, $0.01 par value; 20,000,000 shares authorized, 20,000,000 designated at September 30, 2020 and December 31, 2019, respectively | — | — | ||||||
Series A 12% convertible preferred stock; 1,742,500 shares authorized, 1,302,500 and 1,327,500 issued and outstanding at September 30, 2020 and December 31, 2019, respectively, liquidation value $1,302,500 at September 30, 2020 | 527 | 537 | ||||||
Common stock, $0.001 par value; 100,000,000 shares authorized at September 30, 2020 and December 31, 2019, 57,077,055 and 56,894,642 issued and outstanding at September 30, 2020 and December 31, 2019, respectively | 56 | 56 | ||||||
Additional paid-in capital | 261,316 | 259,673 | ||||||
Retained deficit | (232,080 | ) | (216,394 | ) | ||||
Total stockholders’ equity | 29,819 | 43,872 | ||||||
Total liabilities, redeemable convertible preferred stock and stockholders’ equity | $ | 34,049 | $ | 48,467 | ||||
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 | ||||||||||||
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Total operating expenses | 4,414 | 4,537 | 13,874 | 16,882 | ||||||||||||
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Total operating loss | (4,414 | ) | (4,537 | ) | (13,874 | ) | (16,882 | ) | ||||||||
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Other income (expense): | ||||||||||||||||
Interest income | 6 | 11 | 21 | 37 | ||||||||||||
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Total other income (expense) | 6 | 11 | 21 | 37 | ||||||||||||
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Net loss | $ | (4,408 | ) | $ | (4,526 | ) | $ | (13,853 | ) | $ | (16,845 | ) | ||||
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Preferred stock dividends | (254 | ) | (63 | ) | (827 | ) | (466 | ) | ||||||||
Preferred stock accretion | — | (56 | ) | — | (173 | ) | ||||||||||
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Net loss applicable to common stockholders | $ | (4,662 | ) | $ | (4,645 | ) | $ | (14,680 | ) | $ | (17,484 | ) | ||||
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Net loss per common share — basic and diluted | $ | (0.13 | ) | $ | (0.16 | ) | $ | (0.42 | ) | $ | (0.60 | ) | ||||
Weighted average common shares outstanding — basic | 35,165 | 29,282 | 34,600 | 29,045 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
(in thousands, except per share data) | (in thousands, except per share data) | |||||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 4,780 | $ | 1,503 | $ | 11,605 | $ | 3,671 | ||||||||
General and administrative | 1,146 | 1,360 | 4,007 | 4,579 | ||||||||||||
Total operating expenses | 5,926 | 2,863 | 15,612 | 8,250 | ||||||||||||
Total operating loss | (5,926 | ) | (2,863 | ) | (15,612 | ) | (8,250 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income | 5 | 101 | 64 | 158 | ||||||||||||
Interest expense | (22 | ) | (22 | ) | (65 | ) | (65 | ) | ||||||||
Total other income (expense) | (17 | ) | 79 | (1 | ) | 93 | ||||||||||
Net loss | $ | (5,943 | ) | $ | (2,784 | ) | $ | (15,613 | ) | $ | (8,157 | ) | ||||
Preferred stock dividends | (12 | ) | (35 | ) | (72 | ) | (198 | ) | ||||||||
Warrant modification (Note 9) | 0 | — | 0 | (6,622 | ) | |||||||||||
Net loss applicable to common stockholders | $ | (5,955 | ) | $ | (2,819 | ) | $ | (15,685 | ) | $ | (14,977 | ) | ||||
Net loss per common share — basic and diluted | $ | (0.10 | ) | $ | (0.05 | ) | $ | (0.28 | ) | $ | (0.27 | ) | ||||
Weighted average common shares outstanding — basic and diluted | 57,047 | 56,631 | 57,013 | 55,494 |
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 | ||||||
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Net cash used in operating activities | (11,988 | ) | (11,544 | ) | ||||
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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 | ||||||
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Net cash provided by financing activities | 3,584 | 1,757 | ||||||
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NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS | (8,404 | ) | (9,787 | ) | ||||
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 15,362 | 25,846 | ||||||
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CASH AND CASH EQUIVALENTS, END OF PERIOD | $ | 6,958 | $ | 16,059 | ||||
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NONCASH FINANCING ACTIVITIES: | ||||||||
Payment of preferred stock dividends in common stock | $ | 894 | $ | 534 |
Nine Months Ended September 30, | ||||||||
2020 | 2019 | |||||||
(in thousands) | ||||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
Net loss | $ | (15,613 | ) | $ | (8,157 | ) | ||
Adjustments to reconcile net loss to net cash flows from operating activities: | ||||||||
Stock-based compensation expense | 1,232 | 1,269 | ||||||
Amortization of right to use lease asset | 27 | 26 | ||||||
Non-cash interest expense | 64 | 65 | ||||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses and other assets | (598 | ) | 239 | |||||
Accounts payable and accrued expenses | (299 | ) | (531 | ) | ||||
Net cash from operating activities | (15,187 | ) | (7,089 | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
Net proceeds from issuance of common stock and warrants | 263 | 49,567 | ||||||
Payment of preferred stock dividends | — | (394 | ) | |||||
Net cash flows from financing activities | 263 | 49,173 | ||||||
NET DECREASE IN CASH AND CASH EQUIVALENTS | (14,924 | ) | 42,084 | |||||
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 47,480 | 8,253 | ||||||
CASH AND CASH EQUIVALENTS, END OF PERIOD | $ | 32,556 | $ | 50,337 | ||||
NONCASH FINANCING ACTIVITIES: | ||||||||
Payment of preferred stock dividends in common stock | $ | 137 | $ | 102 |
Series C Super Dividend Redeemable Convertible Preferred Stock | ||||||||
Number of Shares | Amount | |||||||
Balance at December 31, 2018 | 176 | $ | 1,723 | |||||
Balance at September 30, 2019 | 176 | $ | 1,723 | |||||
Balance at December 31, 2019 | 176 | $ | 1,723 | |||||
Balance at September 30, 2020 | 176 | $ | 1,723 | |||||
Series A 12% Convertible Preferred Stock | Series B-1 12%Convertible Preferred Stock | Series B-2 12%Convertible Preferred Stock | Series B-3 8%Convertible Preferred Stock | Common Stock | ||||||||||||||||||||||||||||||||||||||||||||||||
Number of Shares | Amount | Number of Shares | Amount | Number of Shares | Amount | Number of Shares | Amount | Number of Shares | Amount | Additional Paid-In Capital | Retained Deficit | Total Stockholders’ Equity (Deficit) | ||||||||||||||||||||||||||||||||||||||||
Balance at | 1,327,500 | $ | 537 | 0 | $ | 0 | 0 | $ | 0 | 0 | $ | 0 | 56,591,278 | $ | 56 | $ | 257,678 | $ | (208,373 | ) | $ | 49,898 | ||||||||||||||||||||||||||||||
Series A 12 % convertible preferred stock dividend | 13,275 | 49 | (9 | ) | 40 | |||||||||||||||||||||||||||||||||||||||||||||||
Series C super dividend redeemable convertible preferred stock dividend | 14,280 | 53 | (25 | ) | 28 | |||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock | 40,026 | 163 | 163 | |||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 414 | 414 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | (2,784 | ) | (2,784 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2019 | 1,327,500 | $ | 537 | 0 | $ | 0 | 0 | $ | 0 | 0 | $ | 0 | 56,658,859 | $ | 56 | $ | 258,357 | $ | (211,191 | ) | $ | 47,759 | ||||||||||||||||||||||||||||||
Balance at June 30, 2020 | 1,327,500 | $ | 537 | 0 | $ | 0 | 0 | $ | 0 | 0 | $ | 57,043,661 | $ | 56 | $ | 260,820 | $ | (226,124 | ) | $ | 35,289 | |||||||||||||||||||||||||||||||
Series A 12 % convertible preferred stock dividend | 13,025 | 35 | 4 | 39 | ||||||||||||||||||||||||||||||||||||||||||||||||
Series C super dividend redeemable convertible preferred stock dividend | 15,816 | 42 | (16 | ) | 26 | |||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock for conversion of Series A 12% Convertible Preferred Stock | (25,000 | ) | (10 | ) | 4,553 | 11 | (1 | ) | ||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 408 | 408 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | (5,943 | ) | (5,943 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2020 | 1,302,500 | $ | 527 | 0 | $ | 0 | 0 | $ | 0 | 0 | $ | 0 | 57,077,055 | $ | 56 | $ | 261,316 | $ | (232,080 | ) | $ | 29,819 | ||||||||||||||||||||||||||||||
Series A 12% Convertible Preferred St o ck | Series B-1 12%Convertible Preferred Stock | Series B-2 12%Convertible Preferred Stock | Series B-3 8%Convertible Preferred Stock | Common Stock | ||||||||||||||||||||||||||||||||||||||||||||||||
Number of Shares | Amount | Number of Shares | Amount | Number of Shares | Amount | Number of Shares | Amount | Number of Shares | Amount | Additional Paid-In Capital | Retained Deficit | Total Stockholders’ Equity (Deficit) | ||||||||||||||||||||||||||||||||||||||||
Balance at December 31, 2018 | 1,327,500 | $ | 537 | 900,000 | $ | 1,761 | 2,100,000 | $ | 3,697 | 2,508,000 | $ | 1,224 | 41,190,905 | $ | 41 | $ | 194,130 | $ | (196,215 | ) | $ | 5,175 | ||||||||||||||||||||||||||||||
Series A 12 % convertible preferred stock dividend | 13,275 | 49 | (89 | ) | (40 | ) | ||||||||||||||||||||||||||||||||||||||||||||||
Series B-1 12% convertible preferred stock dividend | (6 | ) | (6 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||
Series B-2 12% convertible preferred stock dividend | (15 | ) | (15 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||
Series B-3 8% convertible preferred stock dividend | (9 | ) | (9 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||
Series C super dividend redeemable convertible preferred stock dividend | 14,280 | 53 | (78 | ) | (25 | ) | ||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock | 10,923,420 | 10 | 46,907 | 46,917 | ||||||||||||||||||||||||||||||||||||||||||||||||
Conversion of Series B Convertible Preferred to common | (900,000 | ) | (1,761 | ) | (2,100,000 | ) | (3,697 | ) | (2,508,000 | ) | (1,224 | ) | 3,789,346 | 4 | 6,678 | |||||||||||||||||||||||||||||||||||||
Issuance of common stock for exercise of warrants and options | 727,633 | 1 | 2,649 | 2,650 | ||||||||||||||||||||||||||||||||||||||||||||||||
Warrant modification (Note 9) | 6,622 | (6,622 | ) | |||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 1,269 | 1,269 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | (8,157 | ) | (8,157 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2019 | 1,327,500 | $ | 537 | 0 | $ | 0 | 0 | $ | 0 | 0 | $ | 0 | 56,658,859 | $ | 56 | $ | 258,357 | $ | (211,191 | ) | $ | 47,759 | ||||||||||||||||||||||||||||||
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 | 26,300 | 61 | (22 | ) | 39 | |||||||||||||||||||||||||||||||||||||||||||||||
Series C super dividend redeemable convertible preferred stock dividend | 33,416 | 76 | (50 | ) | 26 | |||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock | 14,452 | 44 | 44 | |||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock for conversion of Series A 12% Convertible Preferred Stock | (25,000 | ) | (10 | ) | 4,553 | 11 | (1 | ) | ||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock for exercise of warrants and options | 84,624 | 219 | 219 | |||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 19,068 | 1,232 | 1,232 | |||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | (15,613 | ) | (15,613 | ) | ||||||||||||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2020 | 1,302,500 | $ | 527 | — | $ | — | — | $ | — | — | $ | — | 57,077,055 | $ | 56 | $ | 261,316 | $ | (232,080 | ) | $ | 29,819 | ||||||||||||||||||||||||||||||
and Liquidity
2019.
and Other
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 | ||||||
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Total | $ | 4,175 | $ | 2,802 | ||||
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September 30, 2020 | December 31, 2019 | |||||||
(in thousands) | ||||||||
Legal and accounting fees | $ | 117 | $ | 81 | ||||
Acc r ued clinical tr ial costs | 1,050 | — | ||||||
Accrued compensation | 585 | 973 | ||||||
Lease liability | 43 | 39 | ||||||
Accrued research and development costs and other | 2 | — | ||||||
Total | $ | 1,797 | $ | 1,093 | ||||
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 | ||||||||||||
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Total stock-based compensation expense | $ | 230 | $ | 376 | $ | 829 | $ | 2,001 | ||||||||
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Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Research and development | $ | 138 | $ | 74 | $ | 378 | $ | 244 | ||||||||
General and administrative | 270 | 340 | 854 | 1,025 | ||||||||||||
Total stock-based compensation expense | $ | 408 | $ | 414 | $ | 1,232 | $ | 1,269 | ||||||||
Shares | Weighted Average Exercise Price | |||||||
Outstanding, December 31, 2016 | 4,656,888 | $ | 4.30 | |||||
Granted | — | — | ||||||
Exercised | — | — | ||||||
Options forfeited/cancelled | — | — | ||||||
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Outstanding, September 30, 2017 | 4,656,888 | $ | 4.30 | |||||
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2020:
Shares | Weighted Average Exercise Price | |||||||
Outstanding, December 31, 2019 | 3,000,256 | $ | 4.88 | |||||
Granted | 1,095,000 | 2.51 | ||||||
Exercised | (84,624 | ) | 2.61 | |||||
Options forfeited/cancelled | (23,057 | ) | 1.80 | |||||
Outstanding, September 30, 2020 | 3,987,575 | $ | 4.29 | |||||
2020.
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The following table summarizes the
Nine Months Ended September 30, | Nine Months Ended September 30, | |||||||
2020 | 2019 | |||||||
Risk-free interest rate | 1.26 | % | 2.68 | % | ||||
Expected life of the options | 6 years | 6 years | ||||||
Expected volatility of the underlying stock | 98 | % | 104 | % | ||||
Expected dividend rate | 0 | % | 0 | % |
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On March 12, 2015, the Company granted 81,352lieu of cash retainers for 2019. A total of 19,068 shares of restricted stock tonon-employee directors as a component of their compensation. A total of 77,784 shares were issuedvalued at approximately $90,000 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 16, 2020 when the restricted sharesstock vested in full.
4.twelve quarters following the date of grant.
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 | |||||
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Outstanding, September 30, 2017 | 12,249,590 | $ | 3.22 | |||||
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5.2020:
Weighted Average | ||||||||
Outstanding, December 31, 2019 | 12,538,204 | $ | 4.22 | |||||
Granted | — | — | ||||||
Exercised | — | — | ||||||
Forfeited/cancelled | — | — | ||||||
Outstanding, September 30, 2020 | 12,538,204 | $ | 4.22 | |||||
6.2019.
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.
September 30, 2020 (shares) | September 30, 2019 (shares) | |||||||
Warrants to purchase shares of common stock | 12,538,204 | 12,540,679 | ||||||
Options to purchase shares of common stock | 3,987,575 | 3,062,338 | ||||||
Shares of common stock issuable upon conversion of preferred stock | 510,424 | 514,602 | ||||||
17,036,203 | 16,117,619 | |||||||
2014
$44,000.
2017 Private Placement
dividends on Series A and Series C Preferred Stock.
Other
Through September 30, 2017, the Company has issued a total of 393,235 shares of common stock for dividends on Series A, Series B and Series C Preferred Stock for 2017.
8.zero dividends.
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.
9.of September 30, 2020 in thousands:
2020 | $ | 12 | ||
2021 | 48 | |||
2022 | 8 | |||
Total | 68 | |||
Less imputed interest | 6 | |||
Present value of lease liability | $ | 62 | ||
ongoinga second Phase 22B clinical studytrial in NASH patients with well compensated cirrhosisNASH-CX latter was confirmed in a Type C meeting with FDA in February 2019. Thereafter, the Company with its external NASH consultants designed a Phase 3 study that was sent to various contract research organizations (CROs) for their input on feasibility, timing costs and other important considerations. At the request of the United States Food and Drug Administration (FDA), the trial patients have completed all infusions/dosingprotocol and final HVPGanswers to questions raised by FDA at the February meeting was submitted as a Type C (Written Response Only) request to FDA on July 17, 2019; this response sought FDA feedback and liver biopsyagreement with regards to the proposed clinical program. Further details on results of the
ongoing NASH-RX trial.
tissues.
Indication | Drug | Status | ||
Fibrosis | ||||
NASH with Advanced Fibrosis: NASH-CX trial andNASH-FX trial | IND submitted January 2013. Results from the Phase 1 clinical trial were reported in 2014, with final results reported in January 2015. The Phase | |||
The Phase 2 NASH CX trial, was designed for patients with well compensated cirrhosis. The NASH CX trial top line data Gastroenterology | ||||
NASH – RX | Based on FDA feedback, the NASH-RX trial is an adaptive Phase 2b/3 trial for the prevention of varices in NASH patients with well compensated cirrhosis. An interim efficacy analysis will be incorporated to confirm previous Phase 2 data, confirm an optimal dose and reaffirm efficacy, and the end of study endpoints will include development of varices and a composite clinical endpoint including progression to varices requiring treatment (large varices or varices with a red wale). Seewww.clinicaltrials.gov NCT04365868. Patient enrollment commenced in June 2020.A protocol for a hepatic impairment study was filed with FDA on March 30, 2020 This study 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 | In pre-clinical development | |||
Kidney Fibrosis | In pre-clinical development |
Indication | Drug | Status | ||
Cardiac and Vascular Fibrosis | GM-CT-01 | In pre-clinical development | ||
Cancer Immunotherapy | ||||
Melanoma, Head, Neck Squamous Cell Carcinoma (HNSCC) | 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 rd cohort were reported in September 2018. Continuation of trial is ongoing to expand the dataset of melanoma and HNSCC patients at the 4 mg/Kg dose to determine if a possible Phase 2 trial is warranted. | |||
Psoriasis | ||||
Moderate to Severe Plaque Psoriasis Severe Atopic Dermatitis | IND submitted March 2015. A phase 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. |
tolerated. GR-MD-02GR-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 belapectin as the lead candidate in a development program targeted initially at fibrotic liver disease associated with(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.GR-MD-02 belapectin and it showed that with 8 mg/kg LBM dose ofGR-MD-02 belapectin 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 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.consistsconsisted of two separate human clinical trials. The firstprimary clinical trial iswas the Phase 2biswas the primary focus of our program and is 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
The second trial, our Phase 2a pilot trialNASH-FX for patients with NASH advanced fibrosis that explored usecirrhosis.
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.
collaterals circulation.
Further details on this hepatic impairment study can be found on
In September 2018 we announced additional preliminary clinical data from cohort 3 of this investigator-initiated trial. When aggregated with cohorts previously reported, the data shows a 50% objective response rate in advanced melanoma with belapectin in combination with KEYTRUDA, and a significant decrease in the 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 Disease Control Rate (DCR) data. Six patients completed in cohort 3 (8 mg/kg) have now been added to the three patients completed in cohort 2 (4 mg/kg) and five patients completed in cohort 1 (2 mg/kg). Cohorts 1 and 3 each had two patients with an objective response. All three patients in 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 will target to include 15 patients and is planned to have continued belapectin dosing as long as pembrolizumab is administered. Currently more than 40% of the patients in the expansion cohort have been enrolled and further information will be reported as it becomes available. Assuming these additional data are positive, the next logical step could be a Phase II trial.
Psorasis.
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). All three patients showed clinical responses as determined by reduction of EASI and SCORAD during the study. but no subject achieved a primary endpoint. Upon completion of the24-week treatment phase subject 1 met both secondary endpoints ofSCORAD-50 andEASI-50, and subject 2 met one secondary endpoint(EASI-50). Subject 3 approached a secondary endpoint with an EASI reduction of 49% at week 24. There were no drug related adverse events during this trial. These initial findings are believed to suggest a clinically relevant effect. Additionally, the 12 mg/Kg dosage was administered safely in this patient population.
process, as discussed previously.
2019
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 | Nine Months Ended | 2020 as Compared to 2019 | ||||||||||||||||||||||||||||||
September 30, | September 30, | Three Months | Nine Months | |||||||||||||||||||||||||||||
2020 | 2019 | 2020 | 2019 | $ Change | % Change | $ Change | % Change | |||||||||||||||||||||||||
(In thousands, except %) | ||||||||||||||||||||||||||||||||
Research and development | $ | 4,780 | $ | 1,503 | $ | 11,605 | $ | 3,671 | $ | 3,277 | 218 | % | $ | 7,934 | 216 | % |
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 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.
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 | ||||||||||||
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|
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| |||||||||
$ | 3,503 | $ | 3,289 | $ | 10,719 | $ | 11,892 | |||||||||
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|
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
(in thousands) | ||||||||||||||||
Direct external expenses: | ||||||||||||||||
Clinical programs | $ | 3,768 | $ | 718 | $ | 8,566 | $ | 1,648 | ||||||||
Pre-clinical activities | 64 | 232 | 427 | 333 | ||||||||||||
All other research and development expenses | 948 | 553 | 2,612 | 1,690 | ||||||||||||
$ | 4,780 | $ | 1,503 | $ | 11,605 | $ | 3,671 | |||||||||
Dr. Pol Boudes as Chief Medical Officer in March 2020.
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 | )% |
2020 as Compared to 2019 | ||||||||||||||||||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | Three Months | Nine Months | |||||||||||||||||||||||||||||
2020 | 2019 | 2020 | 2019 | $ Change | % Change | $ Change | % Change | |||||||||||||||||||||||||
(In thousands, except %) | ||||||||||||||||||||||||||||||||
General and administrative | $ | 1,146 | $ | 1,360 | $ | 4,007 | $ | 4,579 | $ | (214 | ) | (16 | )% | $ | (572 | ) | (12 | )% |
$211,000.
us.
belapectin.
Other.
We have engaged outside vendors for certain services associated with our clinical trials. These services are generally available from several providers and, accordingly, our arrangements are typically cancellable on 30 days notice.
stock.
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** | Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of theSarbanes-Oxley Act of 2002 | |||||
XBRL Instance | ||||||
XBRL Taxonomy Extension Schema | ||||||
XBRL Taxonomy Calculation Linkbase | ||||||
XBRL Taxonomy Extension Definition Linkbase | ||||||
XBRL Taxonomy Label Linkbase | ||||||
XBRL Taxonomy Presentation Linkbase | ||||||
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/ | |
Name: | ||
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) |
23