TCR² Therapeutics Reports First Quarter 2023 Financial Results and Provides Corporate Update
“We are pleased with our continued progress during the last quarter which included the announcement of the strategic combination of TCR2 with
Recent Developments
- TCR2 announced a strategic combination with
Adaptimmune Therapeutics plc (Adaptimmune ) to create a preeminent cell therapy company for solid tumors. The two companies entered into a definitive agreement under whichAdaptimmune will combine with TCR² in an all-stock transaction. The transaction is expected to close in the second quarter of 2023, subject to approval by TCR2 stockholders andAdaptimmune shareholders and satisfaction or waiver of other closing conditions. Following the closing of the transaction,Adaptimmune shareholders will own approximately 75% and TCR² stockholders will own approximately 25% of the combined company. As a result, and following the closing of the transaction, it is anticipated that the combined company’s cash runway will extend into 2026. A special meeting of TCR2 stockholders to approve the merger withAdaptimmune will be held onMay 30, 2023 . Proxy materials and voting instructions have been made publicly available. Please call TCR2’s proxy solicitor,Innisfree M&A Incorporated , at (877) 750-8233, with any questions. - TCR2 presented Phase 1 gavo-cel data at the
American Association for Cancer Research (AACR) meeting and published preclinical gavo-cel data in OncoImmunology.
Financial Highlights
- Cash Position: TCR2 ended the first quarter of 2023 with
$110.3 million in cash, cash equivalents, and investments compared to$149.2 million as ofDecember 31, 2022 . Net cash used in operations was$40.0 million for the first quarter of 2023 compared to$31.1 million for the first quarter of 2022. - R&D Expenses: Research and development (R&D) expenses were
$29.2 million for the first quarter of 2023 compared to$22.3 million for the first quarter of 2022. The increase in R&D expenses was primarily due to an increase in clinical trial expenses associated with patient treatment and product manufacturing. - Impairment and Restructuring Expenses: Impairment expenses were
$4.0 million for the first quarter of 2023 compared to$0.6 million for the first quarter of 2022. The increase in impairment expenses for the first quarter includes$2.1 million in severance and related costs and$1.9 million in charges related to construction in progress and certain laboratory equipment. - G&A Expenses: General and administrative expenses were
$8.2 million for the first quarter of 2023 compared to$6.3 million for the first quarter of 2022. The increase in general and administrative expenses for the first quarter includes$3.6 million in transactions costs related to the proposed transaction withAdaptimmune . - Net Loss: Net loss was
$40.4 million for the third quarter of 2023 compared to$29.1 million for the first quarter of 2022.
About gavo-cel, TC-510, and TC-520
Our most advanced program, gavo-cel, targets tumors that express the protein mesothelin.
TC-510 is an enhanced version of gavo-cel that co-expresses a PD-1:CD28 chimeric switch receptor that the Company believes may lead to deeper responses and more durable benefit.
TC-520 is the Company’s first TRuC-T cell targeting CD-70-expressing solid and liquid tumors which incorporates IL-15 pathway enhancements designed to improve T-cell persistence. TCR2 is currently advancing TC-520 to Investigational New Drug (IND) status.
About TCR2 Therapeutics
TCR2
Forward-looking Statements
This press release contains forward-looking statements and information within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "will," "could," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavor," "potential," "continue" or the negative of such words or other similar expressions can be used to identify forward-looking statements. These forward-looking statements include, but are not limited to, express or implied statements regarding: the therapeutic potential of gavo-cel, TC-510 and TCR2’s other product candidates, including potential improvements in efficacy, safety and durability in the Phase 2 portion of the gavo-cel trial, expectations regarding future growth and prospects, future clinical development plans and anticipated timing of data updates, the development of the Company’s TRuC-T cells, including their potential characteristics, applications and clinical utility, the potential therapeutic applications of the TCR2’s TruC-T cell platform, expected cash runway of the combined company following the closing of the proposed transaction with
The expressed or implied forward-looking statements included in this press release are only current expectations, beliefs, and predictions and are subject to a number of risks, uncertainties, assumptions and important factors, including, without limitation: uncertainties as to the timing for completion of the transaction with
Moreover, except as required by law, neither TCR2 nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. TCR2 undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
Media Contact:
kathy@kathyvincent.com
Investor Contact:
Chief Financial Officer
eric.sullivan@tcr2.com
TCR2 THERAPEUTICS INC. | |||||||
UNAUDITED CONSOLIDATED BALANCE SHEETS | |||||||
(amounts in thousands, except share data) | |||||||
2023 |
2022 |
||||||
Assets | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 14,446 | $ | 32,746 | |||
Investments | 95,864 | 116,433 | |||||
Prepaid expenses and other current assets | 8,821 | 5,155 | |||||
Assets held for sale | 21,360 | 23,287 | |||||
Total current assets | 140,491 | 177,621 | |||||
Property and equipment, net | 3,342 | 6,166 | |||||
Right-of-use assets, operating leases | 5,811 | 22,510 | |||||
Restricted cash | 1,152 | 1,152 | |||||
Other assets, non-current | 717 | 787 | |||||
Total assets | $ | 151,513 | $ | 208,236 | |||
Liabilities and stockholders’ equity | |||||||
Accounts payable | $ | 6,320 | $ | 2,793 | |||
Accrued expenses and other current liabilities | 9,217 | 10,823 | |||||
Operating lease liabilities | 3,268 | 21,834 | |||||
Operating lease liabilities related to assets held for sale | 28,668 | 28,611 | |||||
Total current liabilities | 47,473 | 64,061 | |||||
Operating lease liabilities, non-current | 2,710 | 3,316 | |||||
Total liabilities | 50,183 | 67,377 | |||||
Stockholders’ equity | |||||||
Common stock, |
4 | 4 | |||||
Additional paid-in capital | 643,257 | 642,644 | |||||
Accumulated other comprehensive income (loss) | (188 | ) | (445 | ) | |||
Accumulated deficit | (541,743 | ) | (501,344 | ) | |||
Total stockholders’ equity | 101,330 | 140,859 | |||||
Total liabilities and stockholders’ equity | $ | 151,513 | $ | 208,236 | |||
TCR2 THERAPEUTICS INC. | ||||||||
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
(amounts in thousands, except share and per share data) | ||||||||
Three Months Ended |
||||||||
2023 | 2022 | |||||||
Operating expenses | ||||||||
Research and development | $ | 29,265 | $ | 22,320 | ||||
Impairments and restructuring charges | 4,041 | 563 | ||||||
General and administrative | 8,201 | 6,320 | ||||||
Total operating expenses | 41,507 | 29,203 | ||||||
Loss from operations | (41,507 | ) | (29,203 | ) | ||||
Interest income, net | 1,111 | 117 | ||||||
Loss before income tax expense | (40,396 | ) | (29,086 | ) | ||||
Income tax expense | 3 | 36 | ||||||
Net loss | $ | (40,399 | ) | $ | (29,122 | ) | ||
Per share information | ||||||||
Net loss per share of common stock, basic and diluted | $ | (1.03 | ) | $ | (0.76 | ) | ||
Weighted average shares outstanding, basic and diluted | 39,220,984 | 38,513,104 | ||||||
TCR2 THERAPEUTICS INC. | |||||||
UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||
(amounts in thousands) | |||||||
Three Months Ended |
|||||||
2023 | 2022 | ||||||
Operating activities | |||||||
Net loss | $ | (40,399 | ) | $ | (29,122 | ) | |
Adjustments to reconcile net loss to cash used in operating activities: | |||||||
Depreciation and amortization | 615 | 706 | |||||
Impairment and restructuring charges | 3,044 | (831 | ) | ||||
Stock-based compensation expense | 579 | 3,177 | |||||
(Accretion) / Amortization on investments | (475 | ) | 20 | ||||
Deferred tax liabilities | - | 21 | |||||
Changes in operating assets and liabilities: | |||||||
Prepaid expenses and other current assets | (1,630 | ) | (4,400 | ) | |||
Operating leases, net | (2,415 | ) | 375 | ||||
Accounts payable | 3,527 | 1,756 | |||||
Accrued expenses and other liabilities | (2,856 | ) | (2,836 | ) | |||
Cash used in operating activities | (40,010 | ) | (31,134 | ) | |||
Investing activities | |||||||
Purchases of equipment | (158 | ) | (1,911 | ) | |||
Software development costs | - | (66 | ) | ||||
Sale of equipment | 543 | - | |||||
Purchases of investments | (13,699 | ) | (148,382 | ) | |||
Proceeds from sale or maturity of investments | 35,000 | 32,989 | |||||
Cash provided by (used in) investing activities | 21,686 | (117,370 | ) | ||||
Financing activities | |||||||
Proceeds from the exercise of stock options | 34 | 115 | |||||
Payment of deferred offering costs | (10 | ) | (56 | ) | |||
Cash provided by financing activities | 24 | 59 | |||||
Net change in cash, cash equivalents, and restricted cash | (18,300 | ) | (148,445 | ) | |||
Cash, cash equivalents, and restricted cash at beginning of year | 33,898 | 223,720 | |||||
Cash, cash equivalents, and restricted cash at end of period | $ | 15,598 | $ | 75,275 |
Source: TCR2 Therapeutics