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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported):

November 10, 2021

 

TCR2 THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware		001-38811		47-4152751
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S Employer Identification No.)

 

100 Binney Street	Suite 710	Cambridge	MA	02142
	(Address of Principal Executive Offices)			(Zip Code)

 

(617) 949-5200

(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
Common Stock	TCRR	The Nasdaq Stock Market, LLC

 

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. ☐

 

 

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Item 2.02 Results of Operations and Financial Condition

 

On November 10, 2021, TCR2 Therapeutics Inc. announced its financial results for the fiscal quarter ended September 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		Press release dated November 10, 2021
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:	November 10, 2021		TCR2 Therapeutics Inc.
			By:	/s/ Mayur (Ian) Somaiya
				Mayur (Ian) Somaiya
				Chief Financial Officer

 

 

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Exhibit 99.1

 

 

 

TCR2 Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update

 

CAMBRIDGE, Mass., November 10, 2021 - 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 third quarter ended September 30, 2021 and provided a corporate update.

 

“Over the last few months, we continue to treat cancer patients in our ongoing gavo-cel Phase 1 clinical trial and have observed meaningful clinical benefit in three different treatment-refractory solid tumor indications,” said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. “As we prepare for the phase 2 trial to be launched in early 2022, we are expanding our US manufacturing footprint and successfully negotiated a clinical trial collaboration agreement with Bristol Myers Squibb, where we will have the opportunity to evaluate the efficacy and duration of gavo-cel in combination with Opdivo and Yervoy. We anticipate selecting the RP2D before year end and look forward to providing an update on gavo-cel in 1Q22 following review by the US Food and Drug Administration.”

 

Recent Developments

 

Gavo-cel:

 

Corporate:

 

 

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Anticipated Milestones

 

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.

 

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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 and the Company’s other product candidates, 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

 

 

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TCR2 THERAPEUTICS INC.

UNAUDITED CONSOLIDATED BALANCE SHEETS

(amounts in thousands, except share data)

 

	September 30, 2021				December 31, 2020
Assets
Current assets
Cash and cash equivalents	$	262,497			$	94,155
Investments		33,244				133,831
Prepaid expenses and other current assets		7,478				7,552
Total current assets		303,219				235,538
Property and equipment, net		12,252				10,013
Right-of-use assets, operating leases		29,432				-
Restricted cash		1,155				583
Other assets, non-current		666				61
Total assets	$	346,724			$	246,195
Liabilities and stockholders’ equity
Accounts payable	$	4,384			$	2,448
Accrued expenses and other current liabilities		8,654				6,392
Operating lease liabilities		3,482				-
Total current liabilities		16,520				8,840
Operating lease liabilities, non-current		23,635				-
Other liabilities		299				807
Total liabilities		40,454				9,647
Stockholders’ equity
Common stock, $0.0001 par value; 150,000,000 shares authorized; 38,220,444 and 33,516,795 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively.		4				3
Additional paid-in capital		628,064				486,197
Accumulated other comprehensive income (loss)		(15	)			63
Accumulated deficit		(321,783	)			(249,715	)
Total stockholders’ equity		306,270				236,548
Total liabilities and stockholders’ equity	$	346,724			$	246,195

 

 

 

 

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TCR2 THERAPEUTICS INC.

UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS

(amounts in thousands, except share and per share data)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2021				2020				2021				2020
Operating expenses
Research and development		$	20,277			$	12,820			$	54,828			$	37,682
General and administrative			5,963				4,371				17,297				12,451
Total operating expenses			26,240				17,191				72,125				50,133
Loss from operations			(26,240	)			(17,191	)			(72,125	)			(50,133	)
Interest income, net			38				300				186				1,546
Loss before income tax expense			(26,202	)			(16,891	)			(71,939	)			(48,587	)
Income tax expense			42				31				129				86
Net loss		$	(26,244	)		$	(16,922	)		$	(72,068	)		$	(48,673	)
Per share information
Net loss per share of common stock, basic and diluted		$	(0.69	)		$	(0.56	)		$	(1.91	)		$	(1.86	)
Weighted average shares outstanding, basic and diluted			38,197,929				30,340,355				37,816,345				26,158,040

 

 

 

 

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TCR2 THERAPEUTICS INC.

UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

(amounts in thousands)

 

	Nine Months Ended September 30,
	2021				2020
Operating activities
Net loss	$	(72,068	)		$	(48,673	)
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation and amortization		1,976				1,114
Stock-based compensation expense		9,525				6,186
Amortization (accretion) on investments		626				(574	)
Deferred tax liabilities		105				86
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(41	)			(1,875	)
Operating leases, net		(2,811	)			-
Accounts payable		2,066				610
Accrued expenses and other liabilities		2,299				(114	)
Cash used in operating activities		(58,323	)			(43,240	)
Investing activities
Purchases of equipment		(4,352	)			(2,523	)
Software development costs		(308	)			-
Purchases of investments		(40,732	)			(162,147	)
Proceeds from sale or maturity of investments		140,622				109,916
Cash provided by (used in) investing activities		95,230				(54,754	)
Financing activities
Proceeds from public offering of common stock, net of issuance costs		131,330				133,570
Proceeds from the exercise of stock options		1,013				742
Payment of deferred offering costs		(336	)			-
Cash provided by financing activities		132,007				134,312
Net change in cash, cash equivalents, and restricted cash		168,914				36,318
Cash, cash equivalents, and restricted cash at beginning of year		94,738				65,713
Cash, cash equivalents, and restricted cash at end of period	$	263,652			$	102,031

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