Form 8-K TCR2 THERAPEUTICS INC. For: Aug 08
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
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(Registrant’s telephone number, including area code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition
On August 8, 2022, TCR2 Therapeutics Inc. announced its financial results for the fiscal quarter ended June 30, 2022. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Report on Form 8-K, including Exhibit 99.1, attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
99.1 |
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104 |
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Inline XBRL cover page |
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: |
August 8, 2022 |
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TCR2 Therapeutics Inc. |
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By: |
/s/ Eric Sullivan |
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Eric Sullivan |
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Chief Financial Officer |
Exhibit 99.1
TCR2 Therapeutics Reports Second Quarter 2022 Financial Results and Provides Corporate Update
- gavo-cel Phase 1 trial dataset anticipated in September 2022
- Initial TC-510 Phase 1 data anticipated in 2H 2022
- Expansion of manufacturing capacity and commencement of gavo-cel clinical trial material production at ElevateBio BaseCamp
CAMBRIDGE, Mass., August 8, 2022 - TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for cancer patients suffering from solid tumors, today announced financial results for the second quarter ended June 30, 2022 and provided a corporate update.
"TCR2 made significant strides this quarter in preparation for our upcoming gavo-cel Phase 1 and TC-510 data expected in the second half of 2022. As part of our commitment to deliver a meaningfully interpretable dataset, we plan to present our gavo-cel Phase 1 trial data on at least 30 patients in September in order to collect additional scans on patients evaluable for efficacy," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "We also continue to expect to present initial safety, efficacy and translational data from our TC-510 Phase 1 clinical trial before the end of 2022. In connection with progressing our two mesothelin-focused clinical trials, we have activated additional clinical sites and expanded our manufacturing capacity through ElevateBio BaseCamp. This will allow us to further accelerate the pace at which we can deliver our unique cell therapy to benefit patients suffering from solid tumors."
Recent Developments
TC-510:
Corporate:
Manufacturing:
Anticipated Milestones
Gavo-cel:
TC-510:
Pipeline:
Financial Highlights
Upcoming Events
TCR2 Therapeutics management is scheduled to participate at the following upcoming conferences.
About TCR2 Therapeutics
TCR2 Therapeutics Inc. is a clinical-stage cell therapy company developing a pipeline of novel T cell therapies for cancer patients suffering from solid tumors. The company is focused on the discovery and development of product candidates against novel and complex targets utilizing its proprietary T cell receptor (TCR) Fusion Construct T cells (TRuC®-T cells). The TRuC platform is designed to specifically recognize and kill cancer cells by harnessing signaling from the entire TCR, independent of human leukocyte antigens (HLA). For more information about TCR2, please visit www.tcr2.com.
About gavo-cel
Gavo-cel is a mesothelin-targeted TRuC-T cell. The ongoing gavo-cel Phase 1/2 clinical trial is evaluating the safety and efficacy of gavo-cel in patients with mesothelin-expressing malignant pleural/peritoneal mesothelioma (MPM), ovarian cancer, non-small cell lung cancer (NSCLC) and cholangiocarcinoma.
About TC-510
TC-510 is a mesothelin-targeted TRuC-T cell that co-expresses a PD-1:CD28 chimeric switch receptor to provide a local costimulatory signal by engaging with PD-L1 expressed in the hostile tumor microenvironment and converting the negative inhibitory signal into a positive costimulatory signal. The TC-510 Phase 1/2 clinical trial is evaluating the safety and efficacy of TC-510 in patients with mesothelin-expressing MPM, ovarian cancer, pancreatic cancer, colorectal cancer and triple negative breast cancer.
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 the Company’s other product candidates, expected progress and timing of updates for the gavo-cel and TC-510 clinical trials, expectations regarding clinical data for gavo-cel and TC-510 and the timing of an IND submission for TC-520, expectations with respect to manufacturing capacity and technical capabilities, including through the Company’s manufacturing partnership with ElevateBio, LLC, expectations with respect to clinical trial demand, future IND-enabling studies and filings, future clinical development plans, expected cash use in 2022 and cash runway into 2024, expectations regarding 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 manufacturing capacity; 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 Mauch
Senior Director, Investor Relations and Corporate Communications
(617) 949-5667
TCR2 THERAPEUTICS INC.
UNAUDITED CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share data)
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June 30, |
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December 31, |
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Assets |
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Current assets |
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Cash and cash equivalents |
$ |
44,211 |
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$ |
222,564 |
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Investments |
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162,027 |
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43,029 |
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Prepaid expenses and other current assets |
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9,592 |
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10,534 |
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Total current assets |
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215,830 |
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276,127 |
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Property and equipment, net |
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27,712 |
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17,075 |
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Right-of-use assets, operating leases |
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62,293 |
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28,283 |
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Restricted cash |
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1,152 |
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1,156 |
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Other assets, non-current |
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1,057 |
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730 |
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Total assets |
$ |
308,044 |
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$ |
323,371 |
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Liabilities and stockholders’ equity |
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Accounts payable |
$ |
5,470 |
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$ |
2,144 |
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Accrued expenses and other current liabilities |
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12,528 |
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13,094 |
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Operating lease liabilities |
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20,574 |
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3,367 |
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Total current liabilities |
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38,572 |
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18,605 |
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Operating lease liabilities, non-current |
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43,209 |
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22,996 |
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Other liabilities |
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- |
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293 |
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Total liabilities |
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81,781 |
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41,894 |
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Stockholders’ equity |
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Common stock, $0.0001 par value; 150,000,000 shares authorized; 38,598,916 and 38,496,484 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively. |
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4 |
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4 |
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Additional paid-in capital |
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637,175 |
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631,008 |
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Accumulated other comprehensive income (loss) |
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(671 |
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(13 |
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Accumulated deficit |
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(410,245 |
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(349,522 |
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Total stockholders’ equity |
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226,263 |
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281,477 |
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Total liabilities and stockholders’ equity |
$ |
308,044 |
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$ |
323,371 |
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TCR2 THERAPEUTICS INC.
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
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Three Months Ended |
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Six Months Ended |
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2022 |
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2021 |
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2022 |
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2021 |
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Operating expenses |
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Research and development |
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$ |
25,767 |
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$ |
18,627 |
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$ |
48,650 |
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$ |
34,551 |
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General and administrative |
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6,004 |
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5,666 |
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12,324 |
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11,334 |
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Total operating expenses |
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31,771 |
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24,293 |
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60,974 |
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45,885 |
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Loss from operations |
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(31,771 |
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(24,293 |
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(60,974 |
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(45,885 |
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Interest income, net |
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298 |
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32 |
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415 |
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148 |
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Loss before income tax expense |
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(31,473 |
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(24,261 |
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(60,559 |
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(45,737 |
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Income tax expense |
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128 |
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51 |
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164 |
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87 |
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Net loss |
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$ |
(31,601 |
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$ |
(24,312 |
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$ |
(60,723 |
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$ |
(45,824 |
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Per share information |
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Net loss per share of common stock, basic and diluted |
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$ |
(0.82 |
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$ |
(0.64 |
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$ |
(1.58 |
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$ |
(1.22 |
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Weighted average shares outstanding, basic and diluted |
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38,566,954 |
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38,176,025 |
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38,540,178 |
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37,622,390 |
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TCR2 THERAPEUTICS INC.
UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS
(amounts in thousands)
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Six Months Ended June 30, |
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2022 |
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2021 |
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Operating activities |
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Net loss |
$ |
(60,723 |
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$ |
(45,824 |
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Adjustments to reconcile net loss to cash used in operating activities: |
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Depreciation and amortization |
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1,410 |
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1,203 |
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Stock-based compensation expense |
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6,024 |
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6,339 |
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(Accretion) / Amortization on investments |
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(140 |
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417 |
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Deferred tax liabilities |
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(293 |
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63 |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets |
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1,119 |
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(490 |
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Operating leases, net |
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3,410 |
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(3,415 |
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Accounts payable |
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(881 |
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2,587 |
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Accrued expenses and other liabilities |
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(591 |
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178 |
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Cash used in operating activities |
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(50,665 |
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(38,942 |
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Investing activities |
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Purchases of equipment |
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(7,893 |
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(2,184 |
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Software development costs |
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(295 |
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(128 |
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Purchases of investments |
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(186,006 |
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(40,732 |
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Proceeds from sale or maturity of investments |
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66,490 |
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105,518 |
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Cash provided by (used in) investing activities |
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(127,704 |
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62,474 |
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Financing activities |
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Proceeds from public offering of common stock, net of issuance costs |
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- |
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131,330 |
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Proceeds from the exercise of stock options |
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143 |
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580 |
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Payment of deferred offering costs |
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(131 |
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(246 |
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Cash provided by financing activities |
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12 |
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131,664 |
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Net change in cash, cash equivalents, and restricted cash |
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(178,357 |
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155,196 |
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Cash, cash equivalents, and restricted cash at beginning of year |
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223,720 |
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94,738 |
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Cash, cash equivalents, and restricted cash at end of period |
$ |
45,363 |
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$ |
249,934 |
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