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CAMBRIDGE, Mass., May 13, 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 first quarter ended March 31, 2019 and provided a corporate update.
"In our first quarter as a public company, TCR2 has continued to execute our vision and objectives," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "During the quarter, we initiated our Phase 1/2 trial for TC-210, progressed TC-110 toward IND submission in the second half of 2019, and highlighted the differentiation of our novel TRuC-T cells in scientific presentations at Keystone Symposia on Cancer Immunotherapy, AACR, and CAR-T Congress USA. These preclinical studies underscore TRuC-T cells’ greater anti-tumor activity, longer persistence, and less cytokine release compared to CAR-T cells."
TC-210 Clinical Trial Design
Summary of Recent Presentations and Publications
TCR2 Therapeutics management are scheduled to present at the following upcoming conferences.
Conference Call Details
TCR2 will host a conference call and live audio webcast to discuss results and provide a corporate update at 5:00 PM ET today. The live call may be accessed by dialing (866) 220-8062 for domestic calls or (470) 495-9169 for international calls and referencing conference ID 2063908. A live audio webcast for the conference call will be available on the Investors page of the Company’s website at investors.tcr2.com. Following the conclusion of the call, the webcast will be available for replay for 30 days.
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 TCR2’s plans to submit an IND for TC-110 in the second half of 2019; the anticipation of an update for TC-210 in the fourth quarter of 2019; expectations for the initiation of operations at TCR2’s Catapult facility; planned dosing cohorts and the number of patients to be treated in TCR2’s Phase 1/2 clinical trial for TC-210 and related effects on TCR2’s manufacturing capacity in the future; and TCR2’s plans to advance its first three TRuC-T cell product candidates into clinical trials by the first half of 2020.
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.
Director, Investor Relations and Corporate Communications
TCR2 THERAPEUTICS INC.
UNAUDITED CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share data)
|Cash and cash equivalents||$||46,405||$||47,674|
|Prepaid expenses and other current assets||3,929||2,326|
|Total current assets||165,585||125,493|
|Property and equipment, net||1,936||1,638|
|Deferred offering costs||—||2,012|
|Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)|
|Accrued expenses and other current liabilities||2,527||2,802|
|Total current liabilities||5,357||5,465|
|Redeemable convertible preferred stock|
|Series A preferred stock, $0.0001 par value; no shares and 45,000,000 authorized at March 31, 2019 and December 31, 2018; no shares and 44,500,001 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively.||—||72,980|
|Series B preferred stock, $0.0001 par value; no shares and 62,500,000 authorized at March 31, 2019 and December 31, 2018, respectively; no shares and 62,500,000 shares issued and outstanding at March 31, 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 and no shares authorized, issued or outstanding at March 31, 2019 and December 31, 2018, respectively.||—||—|
|Common stock, $0.0001 par value; 150,000,000 and 20,988,730 shares authorized at March 31, 2019 and December 31, 2018, respectively; 23,940,025 and 914,602 shares issued at March 31, 2019 and December 31, 2018, respectively; 23,792,193 and 726,994 shares outstanding at March 31, 2019 and December 31, 2018, respectively.||2||—|
|Additional paid-in capital||336,939||—|
|Accumulated other comprehensive income (loss)||1||(106||)|
|Total stockholders’ equity (deficit)||192,047||(85,696||)|
|Total liabilities, redeemable preferred stock and stockholders’ equity (deficit)||$||197,859||$||129,433|
TCR2 THERAPEUTICS INC.
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
|Three Months Ended March 31,|
|Research and development||$||7,889||$||2,893|
|General and administrative||2,886||1,220|
|Total operating expenses||10,775||4,113|
|Loss from operations||(10,775||)||(4,113||)|
|Interest income, net||872||127|
|Accretion of redeemable convertible preferred stock to redemption value||(49,900||)||(10,833||)|
|Net loss attributable to common stockholders||$||(59,803||)||$||(14,819||)|
|Per share information|
|Net loss per share attributable to common stockholders, basic and diluted||$||(4.85||)||$||(28.90||)|
|Weighted average shares outstanding, basic and diluted||12,328,805||512,685|
TCR2 THERAPEUTICS INC.
UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS
(amounts in thousands)
|Three Months Ended March 31,|
|Adjustments to reconcile net loss to cash used in operating activities:|
|Depreciation and amortization||135||76|
|Stock-based compensation expense||1,141||283|
|Accretion on investments||(131||)||(18||)|
|Changes in operating assets and liabilities:|
|Interest receivable on investments||(157||)||(51||)|
|Prepaid expenses and other current assets||(1,207||)||583|
|Accrued expenses and other liabilities||(310||)||(120||)|
|Cash used in operating activities||(10,833||)||(3,012||)|
|Purchase of investments||(86,626||)||(13,369||)|
|Proceeds from maturity of investments||16,819||—|
|Purchases of equipment||(188||)||(368||)|
|Cash used in investing activities||(69,995||)||(13,737||)|
|Proceeds from the sale of Series B preferred stock||—||120,000|
|Proceeds from initial public offering, net of issuance costs||80,213||—|
|Proceeds from the exercise of stock options||—||219|
|Deferred offering costs||(654||)||(3||)|
|Payment of issuance costs||—||(150||)|
|Cash provided by financing activities||79,559||120,066|
|Net change in cash, cash equivalents, and restricted cash||(1,269||)||103,317|
|Cash, cash equivalents, and restricted cash at beginning of year||47,964||20,101|
|Cash, cash equivalents, and restricted cash at end of period||$||46,695||$||123,418|