8-K
false000175001900017500192022-03-222022-03-22

 

 

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.

 

 


 

 

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

 

 


EX-99.1

 

Exhibit 99.1

 

https://cdn.kscope.io/53282474f4c58e0d057fc920d9500d45-img238177558_0.jpg 

 

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:

TCR2 announced the submission of a protocol amendment to the US Food and Drug Administration (FDA) in the first quarter of 2022 for the gavo-cel Phase 2 expansion cohort, including the amendment to treat patients with gavo-cel in combination with Opdivo and/or Yervoy which forms the basis of the Company’s clinical trial collaboration with Bristol Myers Squibb.

 

TC-510:

TCR2 announced the submission of an Investigational New Drug (IND) to the FDA in the first quarter of 2022 for TC-510, the Company’s first enhanced TRuC-T cell targeting mesothelin with a PD-1:CD28 chimeric switch receptor.

Pipeline:

TCR2 announced it will present a poster at the American Association of Cancer Research (AACR) Annual Meeting 2022 featuring new preclinical data on an allogeneic (off-the-shelf) TRuC-T cell, taking place on April 8-13, 2022 in New Orleans, Louisiana. In preclinical studies, this allogeneic product candidate without an enhancement demonstrated improved anti-tumor efficacy associated with enhanced persistence and increased antigen sensitivity in vivo compared to donor-matched autologous TRuC-T cells targeting mesothelin. Furthermore, allogeneic TRuC-T cells generated with an additional knockout of Beta-2-microglobulin (B2M) maintained their potency.
TCR2 announced a strategic research collaboration agreement with Arbor Biotechnologies focused on the further development of a defined set of allogeneic TRuC-T cell therapies. The collaboration leverages Arbor's proprietary CRISPR gene-editing technology, which is tailored to address the underlying pathology of genetic diseases and TCR2's first-in-class TRuC platform, which has demonstrated clinical activity in multiple treatment-refractory mesothelin-expressing solid tumor indications with gavo-cel.

 

 


 

Corporate:

TCR2 announced the appointment of experienced biotech executive Rosemary Harrison, Ph.D., as Chief Business and Strategy Officer where she will be responsible for supporting a range of activities including commercial strategy, operational planning, corporate partnerships and long-term growth opportunities.

 

Anticipated Milestones

Gavo-cel:
o
Present the expanded and complete Phase 1 dataset for gavo-cel in the second quarter of 2022.
o
Initiate the Phase 2 expansion cohort of the ongoing gavo-cel Phase 1/2 clinical trial in the first half of 2022.
o
Provide an initial update from at least one of the Phase 2 expansion cohorts of the ongoing gavo-cel Phase 1/2 clinical trial in the second half of 2022.
TC-510:
o
Report initial safety, efficacy and translational data from at least one of the Phase 1 dose escalation cohorts of the TC-510 Phase 1/2 clinical trial in the second half of 2022.
Pipeline:
o
Initiate IND-enabling studies for TC-520, an enhanced CD70 targeting TRuC-T cell program, in 2022.
o
Select a lead candidate for its allogeneic program in 2022.
Manufacturing:
o
Production of clinical trial material to commence at ElevateBio BaseCamp as capacity is increased in anticipation of demand from the Phase 2 expansion trial of gavo-cel in 2022.

 

Financial Highlights

 

Cash Position: TCR2 ended the fourth quarter of 2021 with $265.6 million in cash, cash equivalents, and investments compared to $228.0 million as of December 31, 2020. Net cash used in operations was $23.3 million for the fourth quarter of 2021 compared to $13.5 million for the fourth quarter of 2020. TCR2 projects net cash use of $115-125 million for 2022. We expect cash on hand to support operations into 2024.

 

R&D Expenses: Research and development expenses were $22.4 million for the fourth quarter of 2021 compared to $14.3 million for the fourth quarter of 2020. The research and development expenses for the fourth quarter of 2021 include restructuring costs of $3.7 million and are partially offset by a $2 million settlement from a vendor due to a commercial dispute. The remaining increase in R&D expenses was primarily due to an increase in headcount and manufacturing facilities.

 

G&A Expenses: General and administrative expenses were $5.2 million for the fourth quarter of 2021 compared to $4.3 million for the fourth quarter of 2020. The increase in general and administrative expenses was primarily due to an increase in personnel costs.

 

Net Loss: Net loss was $27.7 million for the fourth quarter of 2021 compared to $18.5 million for the fourth quarter of 2020.

 

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.

 

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

 

 


 

 

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

 

 

 

 

 


 

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

 

 

 

 

 

 


 

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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