10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 10-Q

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2021

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from ___________ to ___________

Commission file number 001-38811

 

https://cdn.kscope.io/07692824cee48551f110cd09d10a9af5-img15119486_0.jpg

TCR2 Therapeutics Inc.

(Exact name of Registrant as specified in its charter)

 

Delaware

 

47-4152751

(State or other jurisdiction of incorporation or organization)

 

(IRS 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)

 

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, $0.0001 Par Value

 

TCRR

 

The Nasdaq Stock Market, LLC

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or Section 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes  No 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.:

 

Large accelerated filer

 

Accelerated filer

Non-accelerated filer

 

Smaller reporting company

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. 

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes  No 

As of August 2, 2021, there were 38,182,801 shares of the registrant’s Common Stock, $0.0001 par value per share, outstanding.

 

 


TCR2 Therapeutics Inc.

 

Table of Contents

 

PART I

 

 

Item 1.

Financial Statements

7

 

Unaudited Consolidated Balance Sheets as of June 30, 2021 and December 31, 2020

7

 

Unaudited Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2021 and 2020

8

 

Unaudited Consolidated Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 2021 and 2020

9

 

Unaudited Consolidated Statements of Stockholders' Equity as of June 30, 2021 and 2020

10

 

Unaudited Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2021 and 2020

11

 

Notes to the Unaudited Consolidated Financial Statements

12

Item 2.

Management's Discussion and Analysis of Financial Condition and Results of Operations

26

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

35

Item 4.

Controls and Procedures

35

PART II

 

37

Item 1.

Legal Proceedings

37

Item 1A.

Risk Factors

37

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

102

Item 3.

Defaults Upon Senior Securities

102

Item 4.

Mine Safety Disclosures

102

Item 5.

Other Information

102

Item 6.

Exhibits

103

 

Signatures

104

 

 

 

 


Summary of the Material Risks Associated with Our Business

 

Our business is subject to numerous material and other risks and uncertainties that you should be aware of in evaluating our business. These risks are described more fully in “Item 1A—Risk Factors,” and include, but are not limited to, the following:

 

Our approach to the discovery and development of product candidates based on our TRuC-T cell platform represents a novel approach to cancer treatment, which creates significant challenges for us. Further, we are very early in our development efforts. Most of our product candidates are still in preclinical development. If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.
Our business is highly dependent on our clinical trials for our lead product candidates, gavo-cel and TC-110, and we must complete IND-enabling studies and clinical testing before we can seek regulatory approval and begin commercialization of any of our product candidates. We cannot be certain that we will be able to complete ongoing clinical trials, initiate future planned clinical trials, or advance our product candidates into additional trials, or to successfully develop, or obtain regulatory approval for, or successfully commercialize, any of our product candidates.
We have limited experience as a company in conducting clinical trials. Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future clinical trial results. If our preclinical studies and clinical trials are not sufficient to support regulatory approval of any of our product candidates, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such product candidate.
Manufacturing and administering our product candidates are complex and we may encounter difficulties in production, particularly with respect to process development or scaling up of our manufacturing capabilities. If we encounter such difficulties, our ability to provide supply of our TRuC-T cells for clinical trials or for commercial purposes could be delayed or stopped. We plan to establish our own manufacturing facility and infrastructure in addition to or in lieu of relying on third parties for the manufacture of our product candidates and the use of third-party manufacturing suites, which will be costly, time-consuming, and which may not be successful.
The market opportunities for our product candidates may be relatively small as it will be limited to those patients who are ineligible for or have failed prior treatments and our estimates of the prevalence of our target patient populations may be inaccurate.
We plan to rely on third parties to conduct our clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates.
Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability. We have incurred significant losses since inception, and we expect to incur losses over the next several years and may not be able to achieve or sustain revenues or profitability in the future.
The current outbreak of novel coronavirus, or COVID-19, has caused, and could continue to cause, severe disruptions in the U.S., regional and global economies. COVID-19 has affected our on-going clinical trials and could seriously harm our development efforts, increase our costs and expenses and have a material adverse effect on our business, financial condition and results of operations.
If we are unable to obtain and maintain patent protection for any products we develop and for our technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to commercialize any product candidates we may develop, and our technology may be adversely affected.
The U.S. Food and Drug Administration (FDA) regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our product candidates.

 


Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
Our stock price has been and will likely continue to be volatile. Securities class action or other litigation involving our company or members of our management team could also substantially harm our business, financial condition and results of operations.
We are an emerging growth company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our common stock less attractive to investors. We are also a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.

 


FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q of TCR2 Therapeutics Inc. ("we," "us" and "our") contains or incorporates statements that constitute forward-looking statements within the meaning of the federal securities laws. Any statements that do not relate to historical or current facts or matters are forward looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “could,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “continue” or the negative of these terms or other comparable terminology. Forward-looking statements appear in a number of places in this Quarterly Report on Form 10-Q and include, but are not limited to, statements about:

the timing of preclinical studies and clinical trials of gavo-cel, TC-110 and any other product candidates;
our need to raise additional funding before we can expect to generate any revenues from product sales;
our ability to submit our planned INDs, conduct successful clinical trials and obtain regulatory approval for gavo-cel, TC-110 or any other product candidates that we may identify or develop;
the ability of our TRuC-T cell platform to generate and advance additional product candidates;
our ability to establish an adequate safety, potency and purity profile for gavo-cel, TC-110 or any other product candidates that we may identify or develop;
our ability to manufacture gavo-cel, TC-110 or any other product candidate in conformity with our specifications and with the FDA’s requirements and to scale up manufacturing of our product candidates to commercial scale, if approved;
the implementation of our strategic plans for our business, any product candidates we may develop and our technology;
our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
the rate and degree of market acceptance and clinical utility for any product candidates we may develop;
our estimates regarding our expenses, future revenues, capital requirements and our needs for additional financing;
our ability to maintain and establish collaborations;
our ability to effectively manage our anticipated growth;
developments relating to our competitors and our industry, including the impact of government regulation;
our estimates regarding the market opportunities for our product candidates;
our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;
our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for, or ability to obtain, additional financing;
our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act, or the JOBS Act;
the current and future impact of the ongoing COVID-19 pandemic on our business;
our financial performance; and
other risks and uncertainties, including those listed under the section titled “Risk Factors.”

Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, and involve known and unknown risks, uncertainties and other factors including, without limitation, risks, uncertainties and assumptions regarding the continuing impact of the COVID-19 pandemic on our business, operations, strategy, goals and anticipated timelines, our ongoing and planned preclinical activities, our ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, our timelines for regulatory submissions and our financial position that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You are urged to carefully review the disclosures we make concerning these risks and other factors that may affect our business and operating results under “Item 1A. Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2020 and in this Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this document. We do not intend, and undertake no obligation, to update any forward-looking

 


information to reflect events or circumstances after the date of this document or to reflect the occurrence of unanticipated events, unless required by law to do so.

 


Part I

Item 1. Financial Statements

TCR2 THERAPEUTICS INC.

UNAUDITED CONSOLIDATED BALANCE SHEETS

(amounts in thousands, except share data)

 

 

June 30,
2021

 

 

December 31,
2020

 

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

 

 

 

 

 

 

Commitments and contingencies (Note 7)

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares issued or outstanding as of June 30, 2021 and December 31, 2020, respectively.

 

-

 

 

 

-

 

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

 

See accompanying notes to unaudited consolidated financial statements

7


TCR2 THERAPEUTICS INC.

UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS

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

 

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

 

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

 

 

See accompanying notes to unaudited consolidated financial statements

8


TCR2 THERAPEUTICS INC.

UNAUDITED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(amounts in thousands)

 

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net loss

 

$

(24,312

)

 

$

(16,245

)

 

$

(45,824

)

 

$

(31,751

)

Unrealized gain (loss) on investments, net

 

 

25

 

 

 

864

 

 

 

(82

)

 

 

260

 

Comprehensive loss

 

$

(24,287

)

 

$

(15,381

)

 

$

(45,906

)

 

$

(31,491

)

 

See accompanying notes to unaudited consolidated financial statements

 

 

9


TCR2 THERAPEUTICS INC.

UNAUDITED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(amounts in thousands, except share amounts)

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

Accumulated
Other

 

 

Total

 

 

 

Common Stock

 

 

Paid-In

 

 

Accumulated

 

 

Comprehensive

 

 

Stockholders'

 

 

 

 Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

Balance as of December 31, 2020

 

 

33,516,795

 

 

$

3

 

 

$

486,197

 

 

$

(249,715

)

 

$

63

 

 

$

236,548

 

Issuance of common stock, net of issuance costs

 

 

4,590,164

 

 

 

1

 

 

 

131,329

 

 

 

-

 

 

 

-

 

 

 

131,330

 

Exercise of stock options

 

 

52,243

 

 

 

-

 

 

 

376

 

 

 

-

 

 

 

-

 

 

 

376

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

3,120

 

 

 

-

 

 

 

-

 

 

 

3,120

 

Unrealized loss on investments

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(107

)

 

 

(107

)

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(21,512

)

 

 

-

 

 

 

(21,512

)

Balance as of March 31, 2021

 

 

38,159,202

 

 

$

4

 

 

$

621,022

 

 

$

(271,227

)

 

$

(44

)

 

$

349,755

 

Exercise of stock options

 

 

22,129

 

 

 

-

 

 

 

204

 

 

 

-

 

 

 

-

 

 

 

204

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

3,219

 

 

 

-

 

 

 

-

 

 

 

3,219

 

Unrealized gain on investments

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

25

 

 

 

25

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(24,312

)

 

 

-

 

 

 

(24,312

)

Balance as of June 30, 2021

 

 

38,181,331

 

 

$

4

 

 

$

624,445

 

 

$

(295,539

)

 

$

(19

)

 

$

328,891

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

Accumulated
Other

 

 

Total

 

 

 

Common Stock

 

 

Paid-In

 

 

Accumulated

 

 

Comprehensive

 

 

Stockholders'

 

 

 

 Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

Balance as of December 31, 2019

 

 

23,981,109

 

 

$

2

 

 

$

342,896

 

 

$

(182,591

)

 

$

142

 

 

$

160,449

 

Reclassification of shares issued and previously subject to repurchase

 

 

17,456

 

 

 

-

 

 

 

13

 

 

 

-

 

 

 

-

 

 

 

13

 

Exercise of stock options

 

 

57,904

 

 

 

-

 

 

 

185

 

 

 

-

 

 

 

-

 

 

 

185

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

2,055

 

 

 

-

 

 

 

-

 

 

 

2,055

 

Unrealized loss on investments

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(604

)

 

 

(604

)

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(15,506

)

 

 

-

 

 

 

(15,506

)

Balance as of March 31, 2020

 

 

24,056,469

 

 

$

2

 

 

$

345,149

 

 

$

(198,097

)

 

$

(462

)

 

$

146,592

 

Reclassification of shares issued and previously subject to repurchase

 

 

17,456

 

 

 

-

 

 

 

13

 

 

 

-

 

 

 

-

 

 

 

13

 

Exercise of stock options

 

 

30,670

 

 

 

-

 

 

 

125

 

 

 

-

 

 

 

-

 

 

 

125

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

2,064

 

 

 

-

 

 

 

-

 

 

 

2,064

 

Unrealized gain on investments

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

864

 

 

 

864

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(16,245

)

 

 

-

 

 

 

(16,245

)

Balance at June 30, 2020

 

 

24,104,595

 

 

$

2

 

 

$

347,351

 

 

$

(214,342

)

 

$

402

 

 

$

133,413

 

 

 

See accompanying notes to unaudited consolidated financial statements

 

10


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

 

 

 

-

 

 

See accompanying notes to unaudited consolidated financial statements

11


TCR2 Therapeutics Inc.

Notes to Unaudited Consolidated Financial Statements

(Amounts in thousands, excluding share and per share items or noted otherwise)

 

1. Organization and Description of Business

 

TCR2 Therapeutics Inc. (the Company) is a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer. The Company was incorporated under the laws of the State of Delaware on May 29, 2015 under the name TCR2, Inc. In November 2016, the Company changed its name to TCR2 Therapeutics Inc. The Company’s principal operations are located in Cambridge, Massachusetts.

 

Shelf registration statement

 

On March 16, 2021, the Company filed an automatic shelf registration statement on Form S-3 (the Shelf), with the Securities and Exchange Commission (SEC), which covers the offering, issuance and sale of an indeterminate amount of the Company’s common stock, preferred stock, debt securities, warrants and/or units of any combination thereof. The Shelf was automatically effective when filed. As of June 30, 2021, no sales have been made under the Shelf.

 

Equity offerings

 

On July 31, 2020, the Company closed a public offering of its common stock pursuant to which it issued and sold 9,200,000 shares of its common stock at a price to the public of $15.50 per share. The aggregate net proceeds received by the Company from the offering were approximately $133.6 million after deducting $9.0 million relating to underwriting discounts and commissions and offering expenses.

 

On January 22, 2021, the Company closed a public offering of its common stock pursuant to which it issued and sold 4,590,164 shares of its common stock at a price to the public of $30.50 per share. The aggregate net proceeds received by the Company from the offering were approximately $131.3 million after deducting $8.7 million relating to underwriting discounts and commissions and offering expenses.

 

2. Liquidity

 

The Company’s operations to date have focused on organization and staffing, business planning, raising capital, acquiring technology and assets, manufacturing, conducting preclinical studies and clinical activities. The Company does not have any product candidates approved for sale and has not generated any revenue from product sales. The Company’s product candidates are subject to long development cycles and the Company may be unsuccessful in its efforts to develop, obtain regulatory approval for or market its product candidates.

 

The Company is subject to a number of risks including, but not limited to, the need to obtain adequate additional funding for the ongoing and planned clinical development of its product candidates. Because of the numerous risks and uncertainties associated with pharmaceutical products and development, the Company is unable to accurately predict the timing or amount of funds required to complete development of its product candidates, and costs could exceed the Company’s expectations for a number of reasons, including reasons beyond the Company’s control. The Company is also subject to a number of other risks including possible failure of preclinical studies or clinical trials, the need to obtain marketing approval for its product candidates, the development of new technological innovations by competitors, the need to successfully commercialize and gain market acceptance of any of the Company’s products that are approved and uncertainty around intellectual property matters. If the Company does not successfully commercialize any of its products, it will be unable to generate product revenue or achieve profitability.

 

The Company expects to continue to generate losses for the foreseeable future. The Company expects that its cash, cash equivalents and investments as of June 30, 2021 of $317.3 million will be sufficient to fund its operating expenses and capital expenditure requirements through at least 12 months from the date of issuance of these unaudited consolidated financial statements.

 

12


TCR2 Therapeutics Inc.

Notes to Unaudited Consolidated Financial Statements

(Amounts in thousands, excluding share and per share items or noted otherwise)

 

3. Summary of Significant Accounting Policies

 

Principles of consolidation and basis of presentation

 

The unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) for interim financial information and in accordance with Article 10 of Regulation S-X of the SEC, and reflect the financial position, results of operations and cash flows of the Company's business. Accordingly, they do not include all of the disclosures required by U.S. GAAP for a complete set of annual audited financial statements. All significant intercompany accounts and transactions are eliminated in consolidation.

 

The unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. The accompanying financial information should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company's Annual Report on Form 10-K filed with the SEC on March 16, 2021 for the year ended December 31, 2020 (the 2020 Form 10-K). In the opinion of the Company's management, all adjustments (consisting of normal and recurring adjustments) considered necessary for a fair statement of the results for the interim periods presented have been included.

 

Use of estimates

 

The preparation of the accompanying unaudited consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited consolidated financial statements and reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these unaudited consolidated financial statements include, but are not limited to, the fair value of the royalty transfer agreement obligations, and the fair value of stock-based compensation awards granted under the Company’s equity-based compensation plans. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the consolidated financial statements in the period they are determined to be necessary.

 

Concentrations of credit risk and of manufacturing risk

 

Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents and investments. The Company’s cash, cash equivalents and investments are held by financial institutions in the United States. Amounts on deposit may at times exceed federally insured limits. Management believes that the financial institutions are financially sound, and accordingly, minimal credit risk exists with respect to the financial institutions.

 

As of June 30, 2021, the Company has manufacturing arrangements with vendors for the supply of materials for use in preclinical and clinical studies. If the Company were to experience any disruptions in the party’s ability or willingness to continue to provide manufacturing services, the Company may experience significant delays in its product development timelines and may incur substantial costs to secure alternative sources of manufacturing.

 

Fair value of financial instruments

 

As of June 30, 2021 and December 31, 2020, the Company’s financial instruments consist of money market funds, U.S. Treasury securities, and corporate bonds and are included in investments. The carrying value of investments is the estimated fair value. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.

 

13


TCR2 Therapeutics Inc.

Notes to Unaudited Consolidated Financial Statements

(Amounts in thousands, excluding share and per share items or noted otherwise)

 

Cash equivalents

 

The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. As of June 30, 2021 and December 31, 2020, cash equivalents consisted of U.S treasuries, corporate bonds, and government-backed money market funds.

 

Investments

 

As of June 30, 2021, all investments were classified as available-for-sale and were carried at their estimated fair value. Unrealized gains and losses are recorded as a component of accumulated other comprehensive income (loss) until realized. The Company determines the appropriate classification of its investments in debt securities at the time of purchase and re-evaluates such determination at each balance sheet date. The Company periodically reviews its investments in debt securities for impairment and adjusts these investments to their fair value when a decline in market value is deemed to be other than temporary. If losses on these securities are considered to be other than temporary, the loss is recognized in earnings. The Company classifies its available-for-sale marketable securities as current or non-current based on each instrument’s underlying effective maturity date and for which the Company has the intent and ability to hold the investment for a period of greater than 12 months. Marketable securities with maturities of less than 12 months are classified as current and are included in investments in the consolidated balance sheets. Marketable securities with maturities greater than 12 months for which the Company has the intent and ability to hold the investment for greater than 12 months are classified as non-current and are included in investments, non-current in the consolidated balance sheets.

 

Restricted cash

 

Cash accounts that are restricted as to withdrawal or usage are presented as restricted cash. Restricted cash includes amounts held as a security deposit in the form of a letter of credit for the Company’s leased facilities.

 

Assets not placed in service

 

Assets not placed in service includes direct costs related to the acquisition of property including leasehold improvements. Such costs are not depreciated until the asset is completed and placed into service.

 

Stock-based compensation

 

The Company measures stock-based awards at grant-date fair value and records compensation expense on a straight-line basis over the requisite service period, which is generally the vesting period of the respective award. Generally, the Company issues awards with only service-based vesting conditions. The Company accounts for forfeitures as they occur. For stock-based awards granted to non-employees, compensation expense is recognized over the period during which services are rendered by such non-employees until completed.

 

Stock-options exercised prior to vesting are subject to repurchase by the Company until vested at the lesser of the initial exercise price and the fair market value of the Company’s common stock at the time of repurchase. The proceeds from the shares subject to repurchase are classified as a liability and reclassified to equity as the shares vest.

 

Estimating the fair value of stock options and warrants requires the input of subjective assumptions, including the expected life of the instrument and stock price volatility. The Company uses the Black-Scholes option pricing model to value its stock option awards and warrants. As a result, if factors change and management uses different assumptions, stock-based compensation expense could be materially different for future awards.

 

14


TCR2 Therapeutics Inc.

Notes to Unaudited Consolidated Financial Statements

(Amounts in thousands, excluding share and per share items or noted otherwise)

 

The Company classifies stock-based compensation expense in its statements of operations in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified.

 

Leases

 

At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Leases are classified at their commencement date, which is defined as the date on which the lessor makes the underlying asset available for use by the lessee, as either operating or finance leases based on the economic substance of the agreement. The Company recognizes lease right-of-use assets and related liabilities in its consolidated balance sheets for both operating and finance leases. Lease liabilities are measured at the lease commencement date as the present value of the future lease payments using the interest rate implicit in the lease, or the incremental borrowing rate if the rate implicit in the lease is not readily determinable. Lease right-of-use assets are measured as the lease liability plus initial direct costs and prepaid lease payments less lease incentives. The lease term is the non-cancelable period of the lease and includes options to extend or terminate the lease when it is reasonably certain that an option will be exercised. The Company recognizes operating lease costs in operating expenses in its consolidated statements of operations, inclusive of rent escalation provisions and rent holidays, on a straight-line basis over the respective lease term.

 

Research and development expenses

 

Research and development costs are expensed as incurred and consist primarily of funds paid for employee wages and funds paid to third parties for the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, and regulatory compliance costs. At the end of the reporting period, the Company compares payments made to third party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs.

 

Upfront milestone payments made to third parties who perform research and development services on the Company’s behalf are expensed as services are rendered.

 

Income taxes

 

Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A reduction in the carrying value of the deferred tax assets is required when it is not more likely than not that such deferred tax assets are realizable.

 

Net loss per share

 

Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average shares of common stock outstanding during the period. In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders, since dilutive shares of common stock are not assumed to have been issued if their effect is

15


TCR2 Therapeutics Inc.

Notes to Unaudited Consolidated Financial Statements

(Amounts in thousands, excluding share and per share items or noted otherwise)

 

anti-dilutive. Therefore, the weighted-average shares used to calculate both basic and diluted loss per share are the same.

 

The following potentially dilutive securities, on an as converted basis, have been excluded from the computation of diluted weighted-average shares outstanding as of June 30, 2021 and 2020, as they would be antidilutive:

 

 

As of June 30,

 

 

2021

 

 

2020

 

Stock options outstanding

 

5,202,147

 

 

 

4,162,722

 

Common stock warrants

 

203,676

 

 

 

203,676

 

Employee stock purchase plan

 

7,618

 

 

 

6,831

 

Total

 

5,413,441

 

 

 

4,373,229

 

 

Comprehensive loss

 

Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources (which excludes investments from owners). The Company’s only element of other comprehensive loss is unrealized gains and losses on investments.

 

Common stock

 

Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders.

 

Preferred stock

 

The Board of Directors or any authorized committee thereof is expressly authorized, to the fullest extent permitted by law, to provide by resolution or resolutions for, out of the unissued shares of Undesignated Preferred Stock, the issuance of the shares of Undesignated Preferred Stock in one or more series of such stock, and by filing a certificate of designations pursuant to applicable law of the State of Delaware, to establish or change from time to time the number of shares of each such series, and to fix the designations, powers, including voting powers, full or limited, or no voting powers, preferences and the relative, participating, optional or other special rights of the shares of each series and any qualifications, limitations and restrictions thereof. As of June 30, 2021, there are no preferred shares issued.

 

Reconciliation of cash, cash equivalents and restricted cash as presented in the statements of cash flows

 

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the unaudited consolidated balance sheets to the total of the same such amounts shown in the unaudited consolidated statements of cash flows for the six months ended June 30, 2021 and 2020.

 

 

As of June 30,

 

 

2021

 

 

2020

 

 Cash and cash equivalents

$

248,793

 

 

$

49,695

 

 Restricted cash

 

1,141

 

 

 

417

 

 Cash, cash equivalents and restricted cash shown in the statements of cash flows

$

249,934

 

 

$

50,112

 

 

JOBS Act accounting election

 

The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the JOBS Act). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for

16


TCR2 Therapeutics Inc.

Notes to Unaudited Consolidated Financial Statements

(Amounts in thousands, excluding share and per share items or noted otherwise)

 

public and private companies until the earlier of the date that it is (i) no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, these consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.

 

Recently adopted accounting pronouncements

 

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASC 842”), which amends a number of aspects of lease accounting and requires entities to recognize right-of-use assets and liabilities on the balance sheet. The Company adopted ASC 842 during the second quarter of 2021 effective on January 1, 2021. The Company has finalized its review of its portfolio of existing leases and current accounting policies and has concluded that the amended guidance results in the recognition of additional assets and corresponding liabilities on its balance sheets.

 

In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements (“ASU 2018-11”), which offered a transition option to entities adopting ASC 842. Under ASU 2018-11, entities could elect to apply ASC 842 using a modified-retrospective adoption approach resulting in a cumulative effect adjustment to accumulated deficit at the beginning of the year in which the new lease standard is adopted, rather than adjustments to the earliest comparative period presented in their financial statements.

 

The Company adopted ASC 842, Leases effective January 1, 2021 on a modified retrospective basis under which requires the recognition of lease liabilities and right-of-use assets at the adoption date but does not require retrospective adjustments of prior periods. The Company elected the optional transition approach of not adjusting its comparative period financial statements for the impacts of adoption. The Company elected the package of transition practical expedients for leases that commenced prior to January 1, 2021, allowing it not to reassess (i) whether any expired or existing contracts contain leases, (ii) the lease classification for any expired or existing leases and (iii) the initial indirect costs for any existing leases.

 

The Company recorded, upon adoption of ASC 842 effective January 1, 2021, operating lease assets and liabilities of $11.3 million and $11.8 million, respectively, related to its real estate leases under ASC 842.

 

The cumulative effect of applying ASC 842 on the Company’s consolidated balance sheet as of January 1, 2021 was as follows:

 

Assets

Balance as of
December 31, 2020

 

 

Adjustments

 

 

Balance as of
January 1, 2021

 

Prepaid expenses and other current assets

$

7,552

 

 

$

(154

)

 

$

7,398

 

Right-of-use assets, operating leases

 

-

 

 

 

11,300

 

 

 

11,300

 

Total assets

 

 

 

$

11,146

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities and Shareholders' Equity

 

 

 

 

 

 

 

 

Accrued expenses and other current liabilities

$

6,533

 

 

$

(168

)

 

$

6,365

 

Operating lease liabilities

 

-

 

 

 

2,630

 

 

 

2,630

 

Other liabilities

 

807

 

 

 

(482

)

 

 

325

 

Operating lease liabilities, non-current

 

-

 

 

 

9,166

 

 

 

9,166

 

Total liabilities and shareholders' equity

 

 

 

$

11,146

 

 

 

 

 

Adopting ASC 842 did not result in a material impact to our statement of operations or cash flows.

 

Please refer to Note 8, “Leases,” for further information regarding the Company’s leases as well as certain disclosures required by ASC 842. 

 

17


TCR2 Therapeutics Inc.

Notes to Unaudited Consolidated Financial Statements

(Amounts in thousands, excluding share and per share items or noted otherwise)

 

4. Investments and Fair Value Measurements

 

As of June 30, 2021, investments were comprised of the following:

 

 

 

Amortized
Cost

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair
Value

 

Corporate bonds

 

$

35,576

 

 

$

-

 

 

$

(21

)

 

$

35,555

 

U.S. Treasury securities

 

 

32,996

 

 

 

2

 

 

 

-

 

 

 

32,998

 

Total

 

$

68,572

 

 

$

2

 

 

$

(21

)

 

$

68,553

 

 

As of December 31, 2020, investments were comprised of the following:

 

 

 

Amortized
Cost

 

 

Unrealized
Gains