- IND submission for GTB-3650, 2nd generation nanobody TriKE® for treatment of CD33+ leukemia, expected in Q4 2023
- Phase 1 clinical trial initiation evaluating GTB-3650 for treatment of CD33+ leukemia anticipated in 2024
- Cash of approximately
$16 million as ofSeptember 30, 2023 , provides ample runway to fund operations into 2H 2024; anticipated to be sufficient to initiate clinical trial activities on GTB-3650
“We continue to move forward in advancing our novel portfolio of TriKE® nanobody assets,” said
Third Quarter 2023 Financial Summary
Cash Position: The Company had cash, cash equivalents and short-term investments of
Research and Development (R&D) Expenses: R&D expenses for the three months and nine months ended
General and Administrative (G&A) Expenses: G&A expenses for the three months and nine months ended
Other (Income) Expenses
The Company recorded interest income of
Net Loss: The Company reported a net loss of
About Camelid Antibodies
Camelid antibodies are single domain antibodies (sdAbs) from the Camelidae family of mammals that include llamas, camels, and alpacas. These animals produce two main types of antibodies. One type of antibody camelids produce is the conventional antibody that is made up of two heavy chains and two light chains. They also produce another type of antibody that is made up of only two heavy chains and no light chain. This is known as heavy chain IgG (hcIgG). While these antibodies do not contain the CH1 region, they retain an antigen binding domain called the VHH region. VHH antibodies, also known as single domain antibodies, contain only the VHH region from the camelid antibody. Camelid antibodies have key characteristics, which include high affinity and specificity (equivalent to conventional antibodies), high thermostability, good solubility and strictly monomeric behavior, small size, relatively low production cost, ease of genetic engineering, format flexibility or modularity, low immunogenicity, and a higher penetration rate into tissues.
About
Forward-Looking Statements
Certain statements in this press release may constitute "forward-looking statements" regarding future events and our future results. All statements other than statements of historical facts are statements that could be deemed to be forward-looking statements. These statements are based on current expectations, estimates, forecasts, and projections about the markets in which we operate and the beliefs and assumptions of our management. Words such as "expects," "anticipates," "targets," "goals," "projects", "intends," "plans," "believes," "seeks," "estimates," "endeavors," "strives," "may," or variations of such words, and similar expressions are intended to identify such forward-looking statements. Readers are cautioned that these forward-looking statements are subject to a number of risks, uncertainties and assumptions that are difficult to predict, estimate or verify. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Such risks and uncertainties include those factors described in our most recent annual report on Form 10-K, as such may be amended or supplemented by subsequent quarterly reports on Form 10-Q, or other reports filed with the
TriKE® is a registered trademark owned by
Investor Relations Contact:
cdavis@lifesciadvisors.com
212-915-2577
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except shares and par value)
2023 | 2022 | |||||||
(Unaudited) | ||||||||
ASSETS | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 2,648 | $ | 5,672 | ||||
Short-term investments | 13,366 | 10,836 | ||||||
Prepaid expenses and other current assets | 38 | 54 | ||||||
Total Current Assets | 16,052 | 16,562 | ||||||
Operating lease right-of-use asset | 87 | 165 | ||||||
Deposits | 9 | 9 | ||||||
TOTAL ASSETS | $ | 16,148 | $ | 16,736 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 3,970 | $ | 3,140 | ||||
Accrued expenses | 1,028 | 1,669 | ||||||
Current operating lease liability | 92 | 110 | ||||||
Total Current Liabilities | 5,090 | 4,919 | ||||||
Non-current operating lease liability | - | 64 | ||||||
Warrant liability | 1,053 | 19 | ||||||
Total Liabilities | 6,143 | 5,002 | ||||||
Stockholders’ Equity | ||||||||
Convertible Preferred stock, par value | 1 | 1 | ||||||
Common stock, par value | ||||||||
as of | 42 | 33 | ||||||
Additional paid in capital | 689,065 | 686,168 | ||||||
Accumulated deficit | (679,103 | ) | (674,468 | ) | ||||
Total Stockholders’ Equity | 10,005 | 11,734 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 16,148 | $ | 16,736 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
For The Three Months Ended | For the Nine Months Ended | |||||||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||||||
Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||||||
Operating Expenses: | ||||||||||||||||||||
Research and development (including | 1,364 | 2,743 | 5,109 | 5,969 | ||||||||||||||||
Selling, general and administrative (including | 1,758 | 4,280 | 5,299 | 9,510 | ||||||||||||||||
Loss from Operations | (3,122 | ) | (7,023 | ) | (10,408 | ) | (15,479 | ) | ||||||||||||
Other (Income) Expense | ||||||||||||||||||||
Interest income | (216 | ) | (107 | ) | (600 | ) | (151 | ) | ||||||||||||
Interest expense | - | - | 213 | - | ||||||||||||||||
Change in fair value of derivative liability | (485 | ) | (58 | ) | (4,796 | ) | (81 | ) | ||||||||||||
Gain on extinguishment of debt | - | - | (547 | ) | - | |||||||||||||||
Unrealized (gain) loss on short term investments | (5 | ) | 23 | (43 | ) | 53 | ||||||||||||||
Total Other (Income) Expense | (706 | ) | (142 | ) | (5,773 | ) | (179 | ) | ||||||||||||
Net Loss | $ | (2,416 | ) | $ | (6,881 | ) | $ | (4,635 | ) | $ | (15,300 | ) | ||||||||
Net Loss Per Share - Basic and Diluted | $ | (0.06 | ) | $ | (0.22 | ) | $ | (0.12 | ) | $ | (0.48 | ) | ||||||||
Weighted average common shares outstanding - basic and diluted | 41,016,075 | 31,380,634 | 40,095,945 | 31,723,792 |
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands)
For The Three Months Ended | ||||||||||||||||||||||||||||||||||||
Preferred Shares | Common Shares | Common Shares Issuable | Additional Paid in | Accumulated | ||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||||||||
Balance, | 96 | $ | 1 | 40,640 | $ | 41 | - | $ | - | $ | 688,408 | $ | (676,687 | ) | $ | 11,763 | ||||||||||||||||||||
Fair value of vested stock options | - | - | - | - | - | - | 433 | - | 433 | |||||||||||||||||||||||||||
Issuance of common stock to an officer and a board member for services | - | - | 400 | 1 | - | - | 114 | - | 115 | |||||||||||||||||||||||||||
Issuance of common stock in settlement of accounts payable and accrued expenses | - | - | 379 | - | - | - | 110 | - | 110 | |||||||||||||||||||||||||||
Net loss | - | - | - | - | - | - | - | (2,416 | ) | (2,416 | ) | |||||||||||||||||||||||||
Balance, | 96 | $ | 1 | 41,419 | $ | 42 | - | $ | - | $ | 689,065 | $ | (679,103 | ) | $ | 10,005 |
For The Nine Months Ended | ||||||||||||||||||||||||||||||||||||
Preferred Shares | Common Shares | Common Shares Issuable | Additional Paid in | Accumulated | ||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||||||||
Balance, | 96 | $ | 1 | 32,723 | $ | 33 | - | $ | - | $ | 686,168 | $ | (674,468 | ) | $ | 11,734 | ||||||||||||||||||||
Private placement of common stock | - | - | 3,600 | 4 | - | - | 6,264 | - | 6,268 | |||||||||||||||||||||||||||
Initial recognition of fair value of warrant liability | - | - | - | - | - | - | (5,831 | ) | - | (5,831 | ) | |||||||||||||||||||||||||
Fair value of vested stock options | - | - | - | - | - | 1,337 | - | 1,337 | ||||||||||||||||||||||||||||
Issuance of common stock to officer and board member for services | - | - | 473 | - | - | - | 430 | - | 430 | |||||||||||||||||||||||||||
Issuance of common stock for exercise of Prefunded Warrants | - | - | 2,900 | 3 | - | - | (3 | ) | - | - | ||||||||||||||||||||||||||
Issuance of common stock in settlement of accounts payable and accrued expenses | - | - | 1,723 | 2 | - | - | 700 | - | 702 | |||||||||||||||||||||||||||
Net loss | - | - | - | - | - | - | - | (4,635 | ) | (4,635 | ) | |||||||||||||||||||||||||
Balance, | 96 | $ | 1 | 41,419 | $ | 42 | - | $ | - | $ | 689,065 | $ | (679,103 | ) | $ | 10,005 |
For The Three Months Ended | ||||||||||||||||||||||||||||||||||||
Preferred Shares | Common Shares | Common Shares Issuable | Additional Paid in | Accumulated | ||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||||||||
Balance, | 96 | $ | 1 | 30,694 | $ | 31 | - | $ | - | $ | 677,411 | $ | (662,003 | ) | $ | 15,440 | ||||||||||||||||||||
Equity compensation to officers, employees, and board of directors | - | - | 78 | - | 378 | 938 | 2,006 | - | 2,944 | |||||||||||||||||||||||||||
Issuance of common shares for services | - | - | 135 | - | - | - | 1,200 | - | 1,200 | |||||||||||||||||||||||||||
Issuance of common shares in settlement of vendors payable | - | - | 1,222 | 1 | - | - | 3,250 | - | 3,251 | |||||||||||||||||||||||||||
Net loss | - | - | - | - | - | - | - | (6,881 | ) | (6,881 | ) | |||||||||||||||||||||||||
Balance, | 96 | $ | 1 | 32,129 | $ | 32 | 378 | $ | 938 | $ | 683,867 | $ | (668,884 | ) | $ | 15,954 |
For The Nine Months Ended | ||||||||||||||||||||||||||||||||||||
Preferred Shares | Common Shares | Common Shares Issuable | Additional Paid in | Accumulated | ||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||||||||
Balance, | 96 | $ | 1 | 32,062 | $ | 32 | 327 | $ | 1,113 | $ | 674,348 | $ | (653,584 | ) | $ | 21,910 | ||||||||||||||||||||
Cancellation of common stock upon settlement with former officer | - | - | (1,845 | ) | (1 | ) | - | - | (222 | ) | - | (223 | ) | |||||||||||||||||||||||
Cancellation of common stock | - | - | (291 | ) | - | - | - | - | - | - | ||||||||||||||||||||||||||
Common shares issued upon conversion of notes payable | - | - | 327 | (327 | ) | (1,113 | ) | 1,113 | - | - | ||||||||||||||||||||||||||
Equity compensation to officers, employees, and board of directors | - | - | 242 | - | 378 | 938 | 2,916 | - | 3,854 | |||||||||||||||||||||||||||
Issuance of common shares for services | - | - | 412 | - | - | - | 2,462 | - | 2,462 | |||||||||||||||||||||||||||
Issuance of common shares in settlement of vendors payable | - | - | 1,222 | 1 | - | - | 3,250 | - | 3,251 | |||||||||||||||||||||||||||
Net loss | - | - | - | - | - | - | - | (15,300 | ) | (15,300 | ) | |||||||||||||||||||||||||
Balance, | 96 | $ | 1 | 32,129 | $ | 32 | 378 | $ | 938 | $ | 683,867 | $ | (668,884 | ) | $ | 15,954 |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
For The Nine Months Ended | ||||||||
2023 | 2022 | |||||||
(Unaudited) | (Unaudited) | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
Net loss | $ | (4,635 | ) | $ | (15,300 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock based compensation – common shares for services | 430 | 5,713 | ||||||
Stock based compensation – vested stock options | 1,337 | 3,854 | ||||||
Change in fair value of warrant liability | (4,796 | ) | (81 | ) | ||||
Gain on extinguishment of debt | (547 | ) | - | |||||
Unrealized (gain) loss on marketable securities | (43 | ) | 53 | |||||
Changes in operating assets and liabilities: | ||||||||
Decrease in prepaid expenses | 16 | 102 | ||||||
Increase in deposits | - | (9 | ) | |||||
Decrease in operating lease right of use assets | 78 | 70 | ||||||
Increase (decrease) in accounts payable and accrued expenses | 1,437 | (5,259 | ) | |||||
(Decrease) in operating lease liability | (82 | ) | (62 | ) | ||||
(6,805 | ) | (10,919 | ) | |||||
CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
Sales (purchases) of investments | (2,487 | ) | 4,639 | |||||
Net Cash Provided by (Used in) Investing Activities | (2,487 | ) | 4,639 | |||||
CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
Proceeds from issuance of common stock and prefunded warrants | 6,268 | - | ||||||
Cancellation of common stock upon settlement with former officer | - | (223 | ) | |||||
6,268 | (223 | ) | ||||||
(3,024 | ) | (6,503 | ) | |||||
Cash at Beginning of Period | 5,672 | 8,968 | ||||||
Cash at End of Period | $ | 2,648 | $ | 2,465 | ||||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||||||||
Cash paid during the year for: | ||||||||
Interest | $ | - | $ | - | ||||
Income taxes paid | $ | - | $ | - | ||||
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES | ||||||||
Right-of-use assets exchanged for lease liabilities | $ | - | $ | 260 | ||||
Initial recognition of fair value of warrant liability | $ | 5,831 | $ | - | ||||
Fair value of common stock issued to settle accounts payable and accrued expenses | $ | 700 | $ | - | ||||
Common stock issued upon conversion of notes payable and accrued interest | $ | - | $ | 1,113 |
Source:
2023 GlobeNewswire, Inc., source