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Share Name | Share Symbol | Market | Type |
---|---|---|---|
TCR2 Therapeutics Inc | NASDAQ:TCRR | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 1.48 | 1.55 | 1.38 | 0 | 01:00:00 |
“2020 was a transformative year for TCR2, with initial clinical data on our lead program, gavo-cel, establishing our leadership position in solid tumors. On the back of encouraging RECIST responses in refractory mesothelioma and ovarian cancer, we were able to strengthen our balance sheet and diversify our investor base, extending our cash runway into 2024 to support our goal of saving the lives of cancer patients,” said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. “We now look to accelerate the development of gavo-cel in 2021 by identifying the recommended Phase 2 dose, initiating the expansion portion of the trial and increasing our manufacturing capacity. We will also provide updates on our rapidly growing pipeline, most immediately with preclinical data presentations at the AACR conference on our allogeneic mesothelin TRuC and our CD70 autologous TRuC.”
Recent Developments
Anticipated Milestones
Financial Highlights
About TCR2 Therapeutics
TCR2 Therapeutics Inc. is a clinical-stage cell therapy company developing a pipeline of novel T cell therapies for patients suffering from solid tumors or hematological malignancies. TCR2’s proprietary T cell receptor (TCR) Fusion Construct T cells (TRuC®-T cells) specifically recognize and kill cancer cells by harnessing signaling from the entire TCR, independent of human leukocyte antigens (HLA). In preclinical studies, TRuC-T cells have demonstrated superior anti-tumor activity compared to chimeric antigen receptor T cells (CAR-T cells), while secreting lower levels of cytokine release. The Company’s lead TRuC-T cell product candidate targeting solid tumors, gavo-cel, is currently being studied in a Phase 1/2 clinical trial to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. The Company’s lead TRuC-T cell product candidate targeting hematological malignancies, TC-110, is currently being studied in a Phase 1/2 clinical trial to treat patients with CD19-positive adult acute lymphoblastic leukemia (aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL). For more information about TCR2, please visit www.tcr2.com.
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, timing for interim updates for the gavo-cel and TC-110 clinical trials and announcement of additional preclinical data, timing for the certification of our manufacturing facility in Stevenage, UK, increased manufacturing capacity and technical capabilities, including relating to our manufacturing partnership with ElevateBio, LLC, increased clinical trial demand, future IND filings and clinical development plans, the development of the Company’s TRuC-T cells, their potential characteristics, applications and clinical utility, and the potential therapeutic applications of the Company’s TRuC-T cell platform.
The expressed or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities, including review under accelerated approval processes; orphan drug designation eligibility; regulatory approvals to conduct trials or to market products; TCR2’s ability to maintain sufficient manufacturing capabilities to support its research, development and commercialization efforts, including TCR2’s ability to secure additional manufacturing facilities; whether TCR2's cash resources will be sufficient to fund TCR2's foreseeable and unforeseeable operating expenses and capital expenditure requirements, the impact of the COVID-19 pandemic on TCR2’s ongoing operations; and other risks set forth under the caption "Risk Factors" in TCR2’s most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although TCR2 believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur.
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. We undertake 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.
Investor and Media Contact:
Carl MauchDirector, Investor Relations and Corporate Communications(617) 949-5667carl.mauch@tcr2.com
TCR2 THERAPEUTICS INC.UNAUDITED CONSOLIDATED BALANCE SHEETS(amounts in thousands, except share data)
December 31, | |||||||
2020 | 2019 | ||||||
Assets | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 94,155 | $ | 65,296 | |||
Investments | 133,831 | 92,828 | |||||
Prepaid expenses and other current assets | 7,552 | 5,061 | |||||
Total current assets | 235,538 | 163,185 | |||||
Property and equipment, net | 10,013 | 4,926 | |||||
Restricted cash | 583 | 417 | |||||
Deferred offering costs | 61 | - | |||||
Total assets | $ | 246,195 | $ | 168,528 | |||
Liabilities and stockholders’ equity | |||||||
Accounts payable | $ | 2,448 | $ | 2,483 | |||
Accrued expenses and other current liabilities | 6,392 | 5,050 | |||||
Total current liabilities | 8,840 | 7,533 | |||||
Other liabilities | 807 | 546 | |||||
Total liabilities | 9,647 | 8,079 | |||||
Stockholders’ equity | |||||||
Common stock, $0.0001 par value; 150,000,000 shares authorized; 33,516,795 and 24,050,936 shares issued; 33,516,795 and 23,981,109 shares outstanding at December 31, 2020 and 2019, respectively. | 3 | 2 | |||||
Additional paid-in capital | 486,197 | 342,896 | |||||
Accumulated other comprehensive income | 63 | 142 | |||||
Accumulated deficit | (249,715 | ) | (182,591 | ) | |||
Total stockholders’ equity | 236,548 | 160,449 | |||||
Total liabilities and stockholders’ equity | $ | 246,195 | $ | 168,528 |
TCR2 THERAPEUTICS INC.UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS(amounts in thousands, except share and per share data)
Three Months EndedDecember 31, | Twelve Months EndedDecember 31, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Operating expenses | ||||||||||||||||
Research and development | $ | 14,298 | $ | 9,392 | $ | 51,980 | $ | 37,488 | ||||||||
General and administrative | 4,269 | 4,179 | 16,720 | 13,894 | ||||||||||||
Total operating expenses | 18,567 | 13,571 | 68,700 | 51,382 | ||||||||||||
Loss from operations | (18,567 | ) | (13,571 | ) | (68,700 | ) | (51,382 | ) | ||||||||
Interest income, net | 191 | 846 | 1,737 | 3,885 | ||||||||||||
Loss before income tax expense | (18,376 | ) | (12,725 | ) | (66,963 | ) | (47,497 | ) | ||||||||
Income tax expense | 75 | 102 | 161 | 102 | ||||||||||||
Net loss | (18,451 | ) | (12,827 | ) | (67,124 | ) | (47,599 | ) | ||||||||
Accretion of redeemable convertible preferred stock to redemption value | - | - | - | $ | (49,900 | ) | ||||||||||
Net loss attributable to common stockholders | $ | (18,451 | ) | $ | (12,827 | ) | $ | (67,124 | ) | $ | (97,499 | ) | ||||
Per share information | ||||||||||||||||
Net loss per share of common stock, basic and diluted | $ | (0.55 | ) | $ | (0.54 | ) | $ | (2.40 | ) | $ | (4.62 | ) | ||||
Weighted average shares outstanding, basic and diluted | 33,448,315 | 23,961,960 | 27,990,564 | 21,104,195 |
TCR2 THERAPEUTICS INC.UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS(amounts in thousands)
Twelve Months Ended December 31, | |||||||
2020 | 2019 | ||||||
Operating activities | |||||||
Net loss | $ | (67,124 | ) | $ | (47,599 | ) | |
Adjustments to reconcile net loss to cash used in operating activities: | |||||||
Depreciation and amortization | 1,592 | 862 | |||||
Stock-based compensation expense | 8,492 | 6,702 | |||||
Accretion on investments | (702 | ) | (225 | ) | |||
Deferred tax liabilities | 131 | - | |||||
Changes in operating assets and liabilities: | |||||||
Prepaid expenses and other current assets | (1,101 | ) | (3,057 | ) | |||
Accounts payable | 451 | (179 | ) | ||||
Accrued expenses and other liabilities | 1,522 | 2,137 | |||||
Cash used in operating activities | (56,739 | ) | (41,359 | ) | |||
Investing activities | |||||||
Purchases of equipment | (7,164 | ) | (3,879 | ) | |||
Purchases of investments | (152,812 | ) | (126,261 | ) | |||
Proceeds from sale or maturity of investments | 111,041 | 109,725 | |||||
Cash used in investing activities | (48,935 | ) | (20,415 | ) | |||
Financing activities | |||||||
Proceeds from public offering of common stock, net of issuance costs | 133,571 | 79,132 | |||||
Proceeds from the exercise of stock options | 1,189 | 391 | |||||
Deferred offering costs | (61 | ) | - | ||||
Cash provided by financing activities | 134,699 | 79,523 | |||||
Net change in cash, cash equivalents, and restricted cash | 29,025 | 17,749 | |||||
Cash, cash equivalents, and restricted cash at beginning of year | 65,713 | 47,964 | |||||
Cash, cash equivalents, and restricted cash at end of period | $ | 94,738 | $ | 65,713 |
1 Year TCR2 Therapeutics Chart |
1 Month TCR2 Therapeutics Chart |
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