tcrr-8k_20210311.htm
false 0001750019 0001750019 2021-03-11 2021-03-11

 

 

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 11, 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)

 

(617949-5200

(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 11, 2021, TCR2 Therapeutics Inc. announced its financial results for the fiscal year ended December 31, 2020. 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 11, 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:

March 11, 2021

 

TCR2 Therapeutics Inc.

 

 

 

 

 

 

 

 

By:

/s/ Mayur (Ian) Somaiya

 

 

 

 

Mayur (Ian) Somaiya

 

 

 

 

Chief Financial Officer

 

 

tcrr-ex991_6.htm

 

Exhibit 99.1

 

TCR2 Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update

 

-

Preliminary safety, efficacy and translational data from gavo-cel Phase 1 trial at AACR 2021

-

Preclinical data on autologous CD70 and allogeneic mesothelin TRuC data at AACR 2021

-

Raised gross proceeds of $140M in a follow-on offering in January; extended cash runway into 2024

 

CAMBRIDGE, Mass., March 11, 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 fourth quarter ended December 31, 2020 and provided a corporate update.

 

“2020 was a transformative year for TCR2, with initial clinical data on our lead program, gavo-cel, establishing our leadership position in solid tumors. On the back of encouraging RECIST responses in refractory mesothelioma and ovarian cancer, we were able to strengthen our balance sheet and diversify our investor base, extending our cash runway into 2024 to support our goal of saving the lives of cancer patients,” said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. “We now look to accelerate the development of gavo-cel in 2021 by identifying the recommended Phase 2 dose, initiating the expansion portion of the trial and increasing our manufacturing capacity. We will also provide updates on our rapidly growing pipeline, most immediately with preclinical data presentations at the AACR conference on our allogeneic mesothelin TRuC and our CD70 autologous TRuC.”

 

Recent Developments

 

 

TCR2 reported a 38% Overall Response Rate with three RECIST partial responses (PRs) (2 confirmed and 1 unconfirmed PRs) from patients in the dose escalation portion of the gavo-cel Phase 1/2 clinical trial, including the first ovarian cancer patient to ever achieve a PR with an engineered cell therapy and one mesothelioma patient achieving a complete metabolic response.

 

TCR2 completed an upsized $140M follow-on offering.

 

TCR2 announced preliminary safety and efficacy data with a focus on translational data of gavo-cel in patients with treatment refractory mesothelin overexpressing solid tumors will be presented in an e-poster presentation at the American Association of Cancer Research (AACR) Virtual Annual Meeting on Saturday, April 10, 2021.

 

TCR2 continues to treat patients in the dose escalation portion of the TC-110 Phase 1/2 clinical trial.  

 

TCR2 announced new preclinical data from its allogeneic TRuC-T cell targeting mesothelin highlighting a lack of alloreactivity, reduced risk of host rejection, upregulation of activation markers, secretion of cytokines and clearance of tumors cells will be presented in an e-poster presentation at the AACR Virtual Annual Meeting on Saturday, April 10, 2021.

 

TCR2 announced new preclinical data from its TRuC-T cell targeting CD70 highlighting T cell expansion, improved memory phenotype, significant anti-tumor efficacy in multiple xenograft mouse models with no

 


 

 

evidence of in vivo fratricide will be presented in an e-poster presentation at the AACR Virtual Annual Meeting on Saturday, April 10, 2021.

 

TCR2 announced the appointment of Shawn Tomasello to its Board of Directors. Ms. Tomasello served as Chief Commercial Officer of Kite Pharma where she oversaw the global commercialization of Yescarta, from 2015 to 2018 including through its acquisition by Gilead for $11.9 billion in October 2017.

 

Anticipated Milestones

 

 

TCR2 to present additional safety, efficacy and translational data from the Phase 1 portion of the gavo-cel Phase 1/2 clinical trial for patients with mesothelin-expressing solid tumors throughout 2021.

 

TCR2 to present an interim update from the Phase 1 portion of the TC-110 Phase 1/2 clinical trial for patients with CD19+ non-Hodgkin lymphoma or adult acute lymphoblastic leukemia in 2021.

 

TCR2 plans to file an IND for TC-510, the first enhanced TRuC-T cell targeting mesothelin with a PD-1:CD28 switch, in 2021.

 

TCR2 plans to select a development candidate for its allogeneic program in 2021.

 

TCR2 anticipates additional pipeline updates throughout 2021.

 

TCR2 anticipates production of gavo-cel clinical trial material from ElevateBio in 2021.

 

TCR2 anticipates MHRA certification of its manufacturing facility in Stevenage, UK, in mid-2021.

 

Financial Highlights

 

 

Cash Position: TCR2 ended 2020 with $228.0 million in cash, cash equivalents, and investments compared to $158.1 million as of December 31, 2019. Year-end 2020 cash balance does not reflect gross proceeds of $140 million from our equity offering in January. Net cash used in operations was $56.7 million for 2020 compared to $41.4 million for 2019. TCR2 projects net cash use of $80-90 million for 2021.

 

 

R&D Expenses: Research and development expenses were $52.0 million for 2020 compared to $37.5 million for 2019. The increase in R&D expenses is primarily related to increase in headcount, activities related to the Phase 1/2 clinical trial of TC-210 and activities related to the Phase 1/2 clinical trial of TC-110.

 

 

G&A Expenses: General and administrative expenses were $16.7 million for 2020 compared to $13.9 million for 2019. The increase in general and administrative expenses was primarily due to an increase in personnel costs.

 

 

Net Loss: Net loss was $67.1 million for 2020 compared to $47.6 million for 2019, driven predominantly by increased personnel expenses.

 

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 solid tumors or hematological malignancies. 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, TC-210, 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 for interim updates for the gavo-cel and TC-110 clinical trials, timing for the certification of our manufacturing facility in Stevenage, UK, increased manufacturing capacity and technical capabilities, including relating to 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)

 

 

December 31,

 

 

2020

 

 

2019

 

Assets

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

Cash and cash equivalents

$

94,155

 

 

$

65,296

 

Investments

 

133,831

 

 

 

92,828

 

Prepaid expenses and other current assets

 

7,552

 

 

 

5,061

 

Total current assets

 

235,538

 

 

 

163,185

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

10,013

 

 

 

4,926

 

Restricted cash

 

583

 

 

 

417

 

Deferred offering costs

 

61

 

 

 

-

 

Total assets

$

246,195

 

 

$

168,528

 

 

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

Accounts payable

$

2,448

 

 

$

2,483

 

Accrued expenses and other current liabilities

 

6,392

 

 

 

5,050

 

Total current liabilities

 

8,840

 

 

 

7,533

 

 

 

 

 

 

 

 

 

Other liabilities

 

807

 

 

 

546

 

Total liabilities

 

9,647

 

 

 

8,079

 

 

 

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

 

 

Common stock, $0.0001 par value; 150,000,000 shares authorized; 33,516,795 and 24,050,936 shares issued; 33,516,795 and 23,981,109 shares outstanding at December 31, 2020 and 2019, respectively.

 

3

 

 

 

2

 

Additional paid-in capital

 

486,197

 

 

 

342,896

 

Accumulated other comprehensive income

 

63

 

 

 

142

 

Accumulated deficit

 

(249,715

)

 

 

(182,591

)

Total stockholders’ equity

 

236,548

 

 

 

160,449

 

Total liabilities and stockholders’ equity

$

246,195

 

 

$

168,528

 


 


 

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,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

14,298

 

 

$

9,392

 

 

$

51,980

 

 

$

37,488

 

General and administrative

 

 

4,269

 

 

 

4,179

 

 

 

16,720

 

 

 

13,894

 

Total operating expenses

 

 

18,567

 

 

 

13,571

 

 

 

68,700

 

 

 

51,382

 

Loss from operations

 

 

(18,567

)

 

 

(13,571

)

 

 

(68,700

)

 

 

(51,382

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income, net

 

 

191

 

 

 

846

 

 

 

1,737

 

 

 

3,885

 

Loss before income tax expense

 

 

(18,376

)

 

 

(12,725

)

 

 

(66,963

)

 

 

(47,497

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income tax expense

 

 

75

 

 

 

102

 

 

 

161

 

 

 

102

 

Net loss

 

 

(18,451

)

 

 

(12,827

)

 

 

(67,124

)

 

 

(47,599

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accretion of redeemable convertible preferred stock to redemption value

 

 

-

 

 

 

-

 

 

 

-

 

 

$

(49,900

)

Net loss attributable to common stockholders

 

$

(18,451

)

 

$

(12,827

)

 

$

(67,124

)

 

$

(97,499

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Per share information

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share of common stock, basic and diluted

 

$

(0.55

)

 

$

(0.54

)

 

$

(2.40

)

 

$

(4.62

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding, basic and diluted

 

 

33,448,315

 

 

 

23,961,960

 

 

 

27,990,564

 

 

 

21,104,195

 

 


 


 

 

TCR2 THERAPEUTICS INC.

UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

(amounts in thousands)

 

Twelve Months Ended December 31,

 

 

2020

 

 

2019

 

Operating activities

 

 

 

 

 

 

 

Net loss

$

(67,124

)

 

$

(47,599

)

Adjustments to reconcile net loss to cash used in operating activities:

 

 

 

 

 

 

 

Depreciation and amortization

 

1,592

 

 

 

862

 

Stock-based compensation expense

 

8,492

 

 

 

6,702

 

Accretion on investments

 

(702

)

 

 

(225

)

Deferred tax liabilities

 

131

 

 

 

-

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

Prepaid expenses and other current assets

 

(1,101

)

 

 

(3,057

)

Accounts payable

 

451

 

 

 

(179

)

Accrued expenses and other liabilities

 

1,522

 

 

 

2,137

 

Cash used in operating activities

 

(56,739

)

 

 

(41,359

)

 

 

 

 

 

 

 

 

Investing activities

 

 

 

 

 

 

 

Purchases of equipment

 

(7,164

)

 

 

(3,879

)

Purchases of investments

 

(152,812

)

 

 

(126,261

)

Proceeds from sale or maturity of investments

 

111,041

 

 

 

109,725

 

Cash used in investing activities

 

(48,935

)

 

 

(20,415

)

 

 

 

 

 

 

 

 

Financing activities

 

 

 

 

 

 

 

Proceeds from public offering of common stock, net of issuance costs

 

133,571

 

 

 

79,132

 

Proceeds from the exercise of stock options

 

1,189

 

 

 

391

 

Deferred offering costs

 

(61

)

 

 

-

 

Cash provided by financing activities

 

134,699

 

 

 

79,523

 

 

 

 

 

 

 

 

 

Net change in cash, cash equivalents, and restricted cash

 

29,025

 

 

 

17,749

 

Cash, cash equivalents, and restricted cash at beginning of year

 

65,713

 

 

 

47,964

 

Cash, cash equivalents, and restricted cash at end of period

$

94,738

 

 

$

65,713

 

# # #

 

Tools