Loading, Please Wait...
CAMBRIDGE, Mass., Nov. 12, 2019 (GLOBE NEWSWIRE) -- TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer, today announced financial results for the third quarter ended September 30, 2019 and provided a corporate update.
“We continued to make clinical progress in the third quarter of 2019 and are positioned to deliver data for our two lead programs next year with interim updates anticipated from the ongoing Phase 1 portion of the TC-210 trial and the upcoming Phase 1 portion of the TC-110 trial," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "2020 represents an important period for the Company in establishing TRuC-T Cells as a viable therapeutic option for cancer patients. We look forward to providing updates not only on TC-210 and TC-110 but also on additional targets and enhancements designed to combat the harsh tumor microenvironment.”
TCR2 Therapeutics management are scheduled to participate at the following upcoming conferences.
About TCR2 Therapeutics
TCR2 Therapeutics Inc. is a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer. TCR2’s proprietary T cell receptor (TCR) Fusion Construct T cells (TRuCTM-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 exhibiting lower levels of cytokine release. The Company’s lead TRuC-T cell product candidate, TC-210, 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. For more information about TCR2, please visit www.tcr2.com.
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 anticipated timing of updates from TCR2’s ongoing Phase 1 portion of the TC-210 clinical trial in 1H20, the upcoming Phase 1 portion of the TC-110 clinical trial in 2H20, and additional targets and platform enhancements, and TCR2’s expectations with respect to its manufacturing capabilities, and financial resources.
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, whether TCR2's cash resources will be sufficient to fund TCR2's foreseeable and unforeseeable operating expenses and capital expenditure requirements; 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:
Director, Investor Relations and Corporate Communications
TCR2 THERAPEUTICS INC.
UNAUDITED CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share data)
|September 30, 2019||December 31, 2018|
|Cash and cash equivalents||$||49,317||$||47,674|
|Prepaid expenses and other current assets||5,612||2,326|
|Total current assets||166,617||125,493|
|Property and equipment, net||4,463||1,638|
|Deferred offering costs||-||2,012|
|Liabilities, redeemable convertible preferred stock and stockholders ’ equity (deficit)|
|Accrued expenses and other current liabilities||4,262||2,802|
|Total current liabilities||7,883||5,465|
|Redeemable convertible preferred stock|
|Series A preferred stock, $0.0001 par value; no shares and 45,000,000 authorized at September 30, 2019 and December 31, 2018; no shares and 44,500,001 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively.||-||72,980|
|Series B preferred stock, $0.0001 par value; no shares and 62,500,000 authorized, issued, and outstanding at September 30, 2019 and December 31, 2018, respectively.||-||136,250|
|Total redeemable convertible preferred stock||-||209,230|
|Stockholders’ equity (deficit)|
|Preferred stock, $0.0001 par value. 10,000,000 shares and no shares authorized, no shares issued or outstanding at September 30, 2019 and December 31, 2018, respectively.||-||-|
|Common stock, $0.0001 par value; 150,000,000 and 20,988,730 shares authorized at September 30, 2019 and December 31, 2018, respectively; 24,033,032 and 914,602 shares issued at September 30, 2019 and December 31, 2018, respectively; 23,944,083 and 726,990 shares outstanding at September 30, 2019 and December 31, 2018, respectively.||2||-|
|Additional paid-in capital||340,686||-|
|Accumulated other comprehensive income (loss)||230||(106||)|
|Total stockholders’ equity (deficit)||171,154||(85,696||)|
|Total liabilities, redeemable preferred stock and stockholders’ equity (deficit)||$||179,511||$||129,433|
TCR2 THERAPEUTICS INC.
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
For the Three Months
Ended September 30,
For the Nine Months
Ended September 30,
|Research and development||$||11,374||$||5,386||$||28,096||$||13,454|
|General and administrative||3,522||1,704||9,715||4,558|
|Total operating expenses||14,896||7,090||37,811||18,012|
|Loss from operations||(14,896||)||(7,090||)||(37,811||)||(18,012||)|
|Interest income, net||1,090||702||3,039||1,451|
|Accretion of redeemable convertible preferred stock to redemption value||-||(11,590||)||(49,900||)||(33,568||)|
|Net loss attributable to common stockholders||$||(13,806||)||$||(17,978||)||$||(84,672||)||$||(50,129||)|
|Per share information|
|Net loss per share of common stock, basic and diluted||$||(0.58||)||$||(27.25||)||$||(4.21||)||$||(83.83||)|
|Weighted average shares outstanding, basic and diluted||23,874,593||659,840||20,125,955||597,964|
TCR2 THERAPEUTICS INC.
UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS
(amounts in thousands)
|For the Nine Months Ended September 30,|
|Adjustments to reconcile net loss to cash used in operating activities:|
|Depreciation and amortization||558||303|
|Stock-based compensation expense||4,597||1,290|
|Accretion on short-term investments||(280||)||(183||)|
|Changes in operating assets and liabilities:|
|Prepaid expenses and other current assets||(3,335||)||500|
|Accrued expenses and other liabilities||1,697||1,775|
|Cash used in operating activities||(31,046||)||(12,308||)|
|Purchase of investments||(126,534||)||(36,039||)|
|Proceeds from sale or maturity of investments||82,990||12,990|
|Purchases of equipment||(3,060||)||(938||)|
|Cash used in investing activities||(46,604||)||(23,987||)|
|Proceeds from the sale of Series B preferred stock, net of issuance costs||-||124,830|
|Proceeds from initial public offering, net of issuance costs||79,121||-|
|Proceeds from the exercise of stock options||299||218|
|Deferred offering costs||-||(792||)|
|Cash provided by financing activities||79,420||124,256|
|Net increase in cash, cash equivalents, and restricted cash||1,770||87,961|
|Cash, cash equivalents, and restricted cash at beginning of year||47,964||20,101|
|Cash, cash equivalents, and restricted cash at end of period||$||49,734||$||108,062|