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)
|
|
|||
(State or other jurisdiction of incorporation) |
|
(Commission File Number) |
|
(I.R.S Employer Identification No.) |
|
(Address of Principal Executive Offices) |
|
(Zip Code) |
|
(
(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) |
|
|
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
|
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 5, 2021, TCR2 Therapeutics Inc. announced its financial results for the fiscal quarter ended June 30, 2021. 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. |
|
Description |
99.1 |
|
|
104 |
|
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 5, 2021 |
|
TCR2 Therapeutics Inc. |
|
|
|
|
|
|
|
|
|
By: |
/s/ Mayur (Ian) Somaiya |
|
|
|
|
Mayur (Ian) Somaiya |
|
|
|
|
Chief Financial Officer |
Exhibit 99.1
TCR2 Therapeutics Reports Second Quarter 2021 Financial Results and Provides Corporate Update
- New clinical data from gavo-cel Phase 1 trial to be presented at European Society of Medical Oncology (ESMO)
- Remain on track to identify recommended Phase 2 dose (RP2D) for gavo-cel in 2021
- TCR2 to host virtual R&D Day on October 20, 2021 to highlight emerging pipeline
CAMBRIDGE, Mass., August 5, 2021 - TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, today announced financial results for the second quarter ended June 30, 2021 and provided a corporate update.
“As we enter the second half of the year, we are approaching the conclusion of the Phase 1 portion of our gavo-cel clinical trial and selection of an RP2D. We look forward to presenting safety, efficacy and translational data from at least 17 patients, up to dose level 5, in an oral presentation at the European Society of Medical Oncology Congress on September 17,” said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. “We believe that gavo-cel has the potential to significantly improve the standard of care for patients with treatment refractory mesothelin-expressing solid tumors. We are focused on identifying the RP2D before the end of 2021 to advance this program into Phase 2 where we can more definitively evaluate efficacy, including retreatment with gavo-cel and combinations with checkpoint inhibitors. We also remain committed to advancing our broad emerging pipeline, including new enhancements, allogeneic TRuC-T cells and new targets and look forward to showcasing these programs at our upcoming virtual R&D Day.”
Recent Developments
Gavo-cel:
Corporate:
Anticipated Milestones
Financial Highlights
Adoption of New Lease Standard
During the second quarter of 2021, TCR2 adopted the new lease standard ASC 842 effective January 1, 2021. The lease standard requires companies to record right-of-use assets and lease liabilities for all leases. With the adoption of the new lease standard, the Company removed its facility in Rockville, MD as an asset under a built-to-suit lease in the amount of $41 million and removed the associated liabilities of $37 million. As of June 30, 2021, the Company’s right-of-use assets under operating leases, including the Rockville facility, were $30.6 million and operating lease liabilities were $27.6 million.
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 patients suffering from cancer. 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 of updates for the gavo-cel and TC-110 clinical trials, expectations with respect to timing of our IND submission for TC-510, expectations regarding preclinical data for our emerging pipeline and enhancements, timing for the certification of operation of our manufacturing facilities in Stevenage, UK and Rockville, MD, increased manufacturing capacity and technical capabilities, including through 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 Mauch
Director, Investor Relations and Corporate Communications
(617) 949-5667
carl.mauch@tcr2.com
TCR2 THERAPEUTICS INC.
UNAUDITED CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share data)
|
June 30, |
|
|
December 31, |
|
||
Assets |
|
|
|
|
|
||
Current assets |
|
|
|
|
|
||
Cash and cash equivalents |
$ |
248,793 |
|
|
$ |
94,155 |
|
Investments |
|
68,553 |
|
|
|
133,831 |
|
Prepaid expenses and other current assets |
|
7,882 |
|
|
|
7,552 |
|
Total current assets |
|
325,228 |
|
|
|
235,538 |
|
|
|
|
|
|
|
||
Property and equipment, net |
|
10,722 |
|
|
|
10,013 |
|
Right-of-use assets, operating leases |
|
30,559 |
|
|
|
- |
|
Restricted cash |
|
1,141 |
|
|
|
583 |
|
Other assets, non-current |
|
490 |
|
|
|
61 |
|
Total assets |
$ |
368,140 |
|
|
$ |
246,195 |
|
|
|
|
|
|
|
||
Liabilities and stockholders’ equity |
|
|
|
|
|
||
Accounts payable |
$ |
4,819 |
|
|
$ |
2,448 |
|
Accrued expenses and other current liabilities |
|
6,533 |
|
|
|
6,392 |
|
Operating lease liabilities |
|
3,594 |
|
|
|
- |
|
Total current liabilities |
|
14,946 |
|
|
|
8,840 |
|
|
|
|
|
|
|
||
Operating lease liabilities, non-current |
|
24,046 |
|
|
|
- |
|
Other liabilities |
|
257 |
|
|
|
807 |
|
Total liabilities |
|
39,249 |
|
|
|
9,647 |
|
|
|
|
|
|
|
||
Stockholders’ equity |
|
|
|
|
|
||
Common stock, $0.0001 par value; 150,000,000 shares authorized; 38,181,331 and 33,516,795 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively. |
|
4 |
|
|
|
3 |
|
Additional paid-in capital |
|
624,445 |
|
|
|
486,197 |
|
Accumulated other comprehensive income |
|
(19 |
) |
|
|
63 |
|
Accumulated deficit |
|
(295,539 |
) |
|
|
(249,715 |
) |
Total stockholders’ equity |
|
328,891 |
|
|
|
236,548 |
|
Total liabilities and stockholders’ equity |
$ |
368,140 |
|
|
$ |
246,195 |
|
TCR2 THERAPEUTICS INC.
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
||||
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
18,627 |
|
|
$ |
12,907 |
|
|
$ |
34,551 |
|
|
$ |
24,862 |
|
General and administrative |
|
|
5,666 |
|
|
|
3,809 |
|
|
|
11,334 |
|
|
|
8,080 |
|
Total operating expenses |
|
|
24,293 |
|
|
|
16,716 |
|
|
|
45,885 |
|
|
|
32,942 |
|
Loss from operations |
|
|
(24,293 |
) |
|
|
(16,716 |
) |
|
|
(45,885 |
) |
|
|
(32,942 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income, net |
|
|
32 |
|
|
|
499 |
|
|
|
148 |
|
|
|
1,246 |
|
Loss before income tax expense |
|
|
(24,261 |
) |
|
|
(16,217 |
) |
|
|
(45,737 |
) |
|
|
(31,696 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Income tax expense |
|
|
51 |
|
|
|
28 |
|
|
|
87 |
|
|
|
55 |
|
Net loss |
|
$ |
(24,312 |
) |
|
$ |
(16,245 |
) |
|
$ |
(45,824 |
) |
|
$ |
(31,751 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Per share information |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share of common stock, basic and diluted |
|
$ |
(0.64 |
) |
|
$ |
(0.67 |
) |
|
$ |
(1.22 |
) |
|
$ |
(1.32 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average shares outstanding, basic and diluted |
|
|
38,176,025 |
|
|
|
24,075,984 |
|
|
|
37,622,390 |
|
|
|
24,043,913 |
|
TCR2 THERAPEUTICS INC.
UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS
(amounts in thousands)
|
Six Months Ended June 30, |
|
|||||
|
2021 |
|
|
2020 |
|
||
Operating activities |
|
|
|
|
|
||
Net loss |
$ |
(45,824 |
) |
|
$ |
(31,751 |
) |
Adjustments to reconcile net loss to cash used in operating activities: |
|
|
|
|
|
||
Depreciation and amortization |
|
1,203 |
|
|
|
673 |
|
Stock-based compensation expense |
|
6,339 |
|
|
|
4,119 |
|
Accretion on investments |
|
417 |
|
|
|
(392 |
) |
Deferred tax liabilities |
|
63 |
|
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
||
Prepaid expenses and other current assets |
|
(490 |
) |
|
|
(3,512 |
) |
Operating leases, net |
|
(3,415 |
) |
|
|
- |
|
Accounts payable |
|
2,587 |
|
|
|
29 |
|
Accrued expenses and other liabilities |
|
178 |
|
|
|
(1,587 |
) |
Cash used in operating activities |
|
(38,942 |
) |
|
|
(32,421 |
) |
|
|
|
|
|
|
||
Investing activities |
|
|
|
|
|
||
Purchases of equipment |
|
(2,184 |
) |
|
|
(1,229 |
) |
Software development costs |
|
(128 |
) |
|
|
- |
|
Purchases of investments |
|
(40,732 |
) |
|
|
(63,005 |
) |
Proceeds from sale or maturity of investments |
|
105,518 |
|
|
|
80,975 |
|
Cash provided by investing activities |
|
62,474 |
|
|
|
16,741 |
|
|
|
|
|
|
|
||
Financing activities |
|
|
|
|
|
||
Proceeds from public offering of common stock, net of issuance costs |
|
131,330 |
|
|
|
- |
|
Proceeds from the exercise of stock options |
|
580 |
|
|
|
310 |
|
Payment of deferred offering costs |
|
(246 |
) |
|
|
(231 |
) |
Cash provided by financing activities |
|
131,664 |
|
|
|
79 |
|
|
|
|
|
|
|
||
Net change in cash, cash equivalents, and restricted cash |
|
155,196 |
|
|
|
(15,601 |
) |
Cash, cash equivalents, and restricted cash at beginning of year |
|
94,738 |
|
|
|
65,713 |
|
Cash, cash equivalents, and restricted cash at end of period |
$ |
249,934 |
|
|
$ |
50,112 |
|
|
|
|
|
|
|
||
Supplemental disclosure of noncash activities |
|
|
|
|
|
||
Property and equipment additions in accounts payable |
$ |
395 |
|
|
$ |
745 |
|
Right-of-use assets obtained in exchange for operating lease liabilities |
|
21,241 |
|
|
|
- |
|
Operating cash flows used in operating leases |
|
6,379 |
|
|
|
- |
|
# # #