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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):

March 22, 2022

 

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 March 22, 2022, TCR2 Therapeutics Inc. announced its financial results for the fiscal quarter ended December 31, 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 March 22, 2022
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:	March 22, 2022		TCR2 Therapeutics Inc.
			By:	/s/ Garry E. Menzel
				Garry E. Menzel
				President and Chief Executive Officer

 

 

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Exhibit 99.1

 

 

 

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

 

CAMBRIDGE, Mass., March 22, 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 fourth quarter ended December 31, 2021 and provided a corporate update.

 

"Consistent execution throughout the last year has positioned TCR2 for a series of important readouts as we accelerate our clinical progress in 2022," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "We were able to successfully conclude the dose escalation portion of our ongoing gavo-cel Phase 1/2 clinical trial with the identification of a RP2D and submit a protocol amendment with the FDA for the upcoming Phase 2 clinical trial. We also submitted an IND with the FDA for our first enhanced TRuC-T cell that incorporates a PD-1:CD28 switch. In the meantime, we have been identifying new clinical trial sites and expanding manufacturing capacity for the reproducible process used by Miltenyi and ElevateBio to support our clinical trials. In addition to the clinical readouts from gavo-cel and TC-510, we will continue to provide updates on the innovations in our rapidly growing pipeline, most immediately with a preclinical data presentation on our allogeneic TRuC targeting mesothelin at the AACR Annual Meeting in April.”

 

Recent Developments

 

Gavo-cel:

 

TC-510:

Pipeline:

 

 

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Corporate:

 

Anticipated Milestones

 

Financial Highlights

 

 

 

 

 

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

 

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from the entire TCR, independent of human leukocyte antigens (HLA). 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, TC-510 and the Company’s other product candidates, expected progess and timing of updates for the gavo-cel and TC-510 clinical trials, expectations with respect to the FDA’s review of our gavo-cel protocol amendments, expectations with respect to timing of our IND submission for TC-510, expectations regarding clinical data for gavo-cel and TC-510 and preclinical data for our emerging pipeline and enhancements, increased manufacturing capacity and technical capabilities, including through our manufacturing partnership with ElevateBio, LLC, expectations with respect to increased clinical trial demand and identification of additional clinical trial sites, future IND filings and clinical development plans, expected cash use in 2022 and cash runway into 2024, 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

Senior 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)

 

	December 31, 2021				December 31, 2020
Assets
Current assets
Cash and cash equivalents	$	222,564			$	94,155
Investments		43,029				133,831
Prepaid expenses and other current assets		10,534				7,552
Total current assets		276,127				235,538
Property and equipment, net		17,075				10,013
Right-of-use assets, operating leases		28,283				-
Restricted cash		1,156				583
Other assets, non-current		730				61
Total assets	$	323,371			$	246,195
Liabilities and stockholders’ equity
Accounts payable	$	2,144			$	2,448
Accrued expenses and other current liabilities		13,094				6,392
Operating lease liabilities		3,367				-
Total current liabilities		18,605				8,840
Operating lease liabilities, non-current		22,996				-
Other liabilities		293				807
Total liabilities		41,894				9,647
Stockholders’ equity
Common stock, $0.0001 par value; 150,000,000 shares authorized; 38,496,484 and 33,516,795 shares issued and outstanding as of December 31, 2021 and December 31, 2020, respectively.		4				3
Additional paid-in capital		631,008				486,197
Accumulated other comprehensive income (loss)		(13	)			63
Accumulated deficit		(349,522	)			(249,715	)
Total stockholders’ equity		281,477				236,548
Total liabilities and stockholders’ equity	$	323,371			$	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 December 31,								Twelve Months Ended December 31,
		2021				2020				2021				2020
Operating expenses
Research and development		$	22,411			$	14,298			$	77,239			$	51,980
General and administrative			5,206				4,269				22,503				16,720
Total operating expenses			27,617				18,567				99,742				68,700
Loss from operations			(27,617	)			(18,567	)			(99,742	)			(68,700	)
Interest income, net			38				191				224				1,737
Loss before income tax expense			(27,579	)			(18,376	)			(99,518	)			(66,963	)
Income tax expense			160				75				289				161
Net loss		$	(27,739	)		$	(18,451	)		$	(99,807	)		$	(67,124	)
Per share information
Net loss per share of common stock, basic and diluted		$	(0.72	)		$	(0.55	)		$	(2.63	)		$	(2.40	)
Weighted average shares outstanding, basic and diluted			38,289,295				33,448,315				37,935,554				27,990,564

 

 

 

 

 

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TCR2 THERAPEUTICS INC.

UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

(amounts in thousands)

 

	Twelve Months Ended December 31,
	2021				2020
Operating activities
Net loss	$	(99,807	)		$	(67,124	)
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation and amortization		2,827				1,592
Asset impairment due to restructuring		559				-
Stock-based compensation expense		12,265				8,492
Amortization (accretion) on investments		837				(702	)
Deferred tax liabilities		99				131
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(2,496	)			(1,101	)
Operating leases, net		(2,416	)			-
Accounts payable		(771	)			451
Accrued expenses and other liabilities		7,300				1,522
Cash used in operating activities		(81,603	)			(56,739	)
Investing activities
Purchases of equipment		(11,098	)			(7,164	)
Software development costs		(351	)			-
Purchases of investments		(50,726	)			(152,812	)
Proceeds from sale or maturity of investments		140,622				111,041
Cash provided by (used in) investing activities		78,447				(48,935	)
Financing activities
Proceeds from public offering of common stock, net of issuance costs		131,330				133,571
Proceeds from the exercise of stock options		1,217				1,189
Payment of deferred offering costs		(409	)			(61	)
Cash provided by financing activities		132,138				134,699
Net change in cash, cash equivalents, and restricted cash		128,982				29,025
Cash, cash equivalents, and restricted cash at beginning of year		94,738				65,713
Cash, cash equivalents, and restricted cash at end of period	$	223,720			$	94,738

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