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 March 31, 2022

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/7a900523ac50a206dce124359e5f92df-img16040125_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 May 2, 2022, there were 38,546,345 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

5

 

Unaudited Consolidated Balance Sheets as of March 31, 2022 and December 31, 2021

5

 

Unaudited Consolidated Statements of Operations for the Three Months Ended March 31, 2022 and 2021

6

 

Unaudited Consolidated Statements of Comprehensive Loss for the Three Months Ended March 31, 2022 and 2021

7

 

Unaudited Consolidated Statements of Stockholders' Equity as of March 31, 2022 and 2021

8

 

Unaudited Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2022 and 2021

9

 

Notes to the Unaudited Consolidated Financial Statements

10

Item 2.

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

24

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

33

Item 4.

Controls and Procedures

33

PART II

 

35

Item 1.

Legal Proceedings

35

Item 1A.

Risk Factors

35

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

96

Item 3.

Defaults Upon Senior Securities

96

Item 4.

Mine Safety Disclosures

96

Item 5.

Other Information

96

Item 6.

Exhibits

97

 

Signatures

98

 

 

 

 


 

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 candidate, gavo-cel, 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-510 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-510 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-510 or any other product candidates that we may identify or develop;
our ability to manufacture gavo-cel, TC-510 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, 2021 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)

 

 

March 31,
2022

 

 

December 31,
2021

 

Assets

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

$

74,117

 

 

$

222,564

 

Investments

 

158,071

 

 

 

43,029

 

Prepaid expenses and other current assets

 

15,115

 

 

 

10,534

 

Total current assets

 

247,303

 

 

 

276,127

 

 

 

 

 

 

 

Property and equipment, net

 

18,767

 

 

 

17,075

 

Right-of-use assets, operating leases

 

55,228

 

 

 

28,283

 

Restricted cash

 

1,158

 

 

 

1,156

 

Other assets, non-current

 

791

 

 

 

730

 

Total assets

$

323,247

 

 

$

323,371

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

Accounts payable

$

4,482

 

 

$

2,144

 

Accrued expenses and other current liabilities

 

9,452

 

 

 

13,094

 

Operating lease liabilities

 

16,933

 

 

 

3,367

 

Total current liabilities

 

30,867

 

 

 

18,605

 

 

 

 

 

 

 

Operating lease liabilities, non-current

 

36,751

 

 

 

22,996

 

Other liabilities

 

313

 

 

 

293

 

Total liabilities

 

67,931

 

 

 

41,894

 

 

 

 

 

 

 

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 March 31, 2022 and December 31, 2021, respectively.

 

-

 

 

 

-

 

Common stock, $0.0001 par value; 150,000,000 shares authorized; 38,546,345 and 38,496,484 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively.

 

4

 

 

 

4

 

Additional paid-in capital

 

634,300

 

 

 

631,008

 

Accumulated other comprehensive income (loss)

 

(344

)

 

 

(13

)

Accumulated deficit

 

(378,644

)

 

 

(349,522

)

Total stockholders’ equity

 

255,316

 

 

 

281,477

 

Total liabilities and stockholders’ equity

$

323,247

 

 

$

323,371

 

See accompanying notes to unaudited consolidated financial statements

5


 

TCR2 THERAPEUTICS INC.

UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS

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

 

 

 

Three Months Ended
March 31,

 

 

 

2022

 

 

2021

 

Operating expenses

 

 

 

 

 

 

Research and development

 

$

22,883

 

 

$

15,924

 

General and administrative

 

 

6,320

 

 

 

5,668

 

Total operating expenses

 

 

29,203

 

 

 

21,592

 

Loss from operations

 

 

(29,203

)

 

 

(21,592

)

 

 

 

 

 

 

 

Interest income, net

 

 

117

 

 

 

116

 

Loss before income tax expense

 

 

(29,086

)

 

 

(21,476

)

 

 

 

 

 

 

 

Income tax expense

 

 

36

 

 

 

36

 

Net loss

 

$

(29,122

)

 

$

(21,512

)

 

 

 

 

 

 

 

Per share information

 

 

 

 

 

 

Net loss per share of common stock, basic and diluted

 

$

(0.76

)

 

$

(0.58

)

 

 

 

 

 

 

 

Weighted average shares outstanding, basic and diluted

 

 

38,513,104

 

 

 

37,062,604

 

 

See accompanying notes to unaudited consolidated financial statements

6


 

TCR2 THERAPEUTICS INC.

UNAUDITED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(amounts in thousands)

 

 

 

Three Months Ended
March 31,

 

 

 

2022

 

 

2021

 

Net loss

 

$

(29,122

)

 

$

(21,512

)

Unrealized gain (loss) on investments, net

 

 

(331

)

 

 

(107

)

Comprehensive loss

 

$

(29,453

)

 

$

(21,619

)

 

See accompanying notes to unaudited consolidated financial statements

 

 

7


 

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, 2021

 

 

38,496,484

 

 

$

4

 

 

$

631,008

 

 

$

(349,522

)

 

$

(13

)

 

$

281,477

 

 Exercise of stock options including ESPP shares issued

 

 

49,861

 

 

 

-

 

 

 

115

 

 

 

-

 

 

 

-

 

 

 

115

 

 Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

3,177

 

 

 

-

 

 

 

-

 

 

 

3,177

 

 Unrealized loss on investments

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(331

)

 

 

(331

)

 Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(29,122

)

 

 

-

 

 

 

(29,122

)

 Balance as of March 31, 2022

 

 

38,546,345

 

 

$

4

 

 

$

634,300

 

 

$

(378,644

)

 

$

(344

)

 

$

255,316

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 including ESPP shares issued

 

 

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

 

 

 

See accompanying notes to unaudited consolidated financial statements

 

8


 

TCR2 THERAPEUTICS INC.

UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

(amounts in thousands)

 

 

Three Months Ended March 31,

 

 

2022

 

 

2021

 

Operating activities

 

 

 

 

 

Net loss

$

(29,122

)

 

$

(21,512

)

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

 

 

 

 

 

Depreciation and amortization

 

706

 

 

 

513

 

Stock-based compensation expense

 

3,177

 

 

 

3,120

 

Amortization on investments

 

20

 

 

 

164

 

Deferred tax liabilities

 

21

 

 

 

36

 

Changes in operating assets and liabilities:

 

 

 

 

 

Prepaid expenses and other current assets

 

(4,400

)

 

 

(2,265

)

Operating leases, net

 

375

 

 

 

(3,808

)

Accounts payable

 

1,756

 

 

 

1,684

 

Accrued expenses and other liabilities

 

(3,667

)

 

 

(1,859

)

Cash used in operating activities

 

(31,134

)

 

 

(23,927

)

 

 

 

 

 

 

Investing activities

 

 

 

 

 

Purchases of equipment

 

(1,911

)

 

 

(1,491

)

Software development costs

 

(66

)

 

 

-

 

Purchases of investments

 

(148,382

)

 

 

(40,732

)

Proceeds from sale or maturity of investments

 

32,989

 

 

 

59,287

 

Cash provided by (used in) investing activities

 

(117,370

)

 

 

17,064

 

 

 

 

 

 

 

Financing activities

 

 

 

 

 

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

 

-

 

 

 

131,330

 

Proceeds from the exercise of stock options

 

115

 

 

 

376

 

Payment of deferred offering costs

 

(56

)

 

 

(164

)

Cash provided by financing activities

 

59

 

 

 

131,542

 

 

 

 

 

 

 

Net change in cash, cash equivalents, and restricted cash

 

(148,445

)

 

 

124,679

 

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

 

223,720

 

 

 

94,738

 

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

$

75,275

 

 

$

219,417

 

 

 

 

 

 

 

Supplemental disclosure of noncash activities

 

 

 

 

 

Property and equipment additions in accounts payable and accrued expenses

$

1,099

 

 

$

309

 

Right-of-use assets obtained in exchange for operating lease liabilities

$

28,831

 

 

$

21,240

 

Operating cash flows used in operating leases

$

3,287

 

 

$

1,661

 

 

See accompanying notes to unaudited consolidated financial statements

9


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. On March 22, 2022, the Company amended the Shelf to cover the offering, issuance and sale of up to an aggregate of $300.0 million of the Company's common stock, preferred stock, debt securities, warrants and/or units of any combination thereof. The amendment to the Shelf was declared effective by the SEC on March 23, 2022. The Company previously entered into a sales agreement with Jefferies LLC, as sales agent, to provide for the issuance and sale by the Company of up to $100.0 million of our common stock from time to time in “at-the-market” offerings under the Shelf, which we refer to as the ATM Program. As of March 31, 2022, no sales have been made under the Shelf or ATM Program.

 

Equity offerings

 

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, and 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 March 31, 2022 of $232.2 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.

 

10


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 22, 2022 for the year ended December 31, 2021 (the 2021 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 March 31, 2022, 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 vendors' 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 March 31, 2022 and December 31, 2021, 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.

 

11


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 March 31, 2022 and December 31, 2021, cash equivalents consisted of U.S treasuries, corporate bonds, and government-backed money market funds.

 

Investments

 

As of March 31, 2022, all investments were classified as available-for-sale and were carried at their estimated fair value. We report available-for-sale investments at fair value at each balance sheet date, and include any unrealized holding gains and losses (the adjustment to fair value) in accumulated other comprehensive income (loss), a component of stockholders' equity. Realized gains and losses are determined using the specific-identification method, and are included in interest income, net in our consolidated statement of operations. 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.

 

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.

 

Impairment of long-lived assets

 

Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated. Impairment charges are recognized at the amount by which the carrying amount of an asset exceeds the fair value of the asset. Assets to be disposed of are reported at the lower of the carrying amount or the fair value less costs to sell. During the year ended December 31, 2021, the Company recognized impairment of long-lived assets in association with the wind down of its manufacturing operations in the United Kingdom. See Note 11, Restructuring. No impairments of long-lived assets for the period ended March 31, 2022 were recognized.

 

Restricted cash

 

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

 

Deferred offering costs

 

The Company capitalizes costs that are directly associated with in-process equity financings until such financings are consummated at which time such costs are recorded against the gross proceeds of the offering. Should the in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the consolidated statements of operations.

 

12


TCR2 Therapeutics Inc.

Notes to Unaudited Consolidated Financial Statements

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

 

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.

 

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.

 

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

13


TCR2 Therapeutics Inc.

Notes to Unaudited Consolidated Financial Statements

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

 

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 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 March 31, 2022 and 2021, as they would be antidilutive:

 

 

As of March 31,

 

 

2022

 

 

2021

 

Stock options outstanding

 

5,905,550

 

 

 

5,084,972

 

Common stock warrants

 

203,676

 

 

 

203,676

 

Restricted stock units

 

66,000

 

 

 

-

 

Employee stock purchase plan

 

10,169

 

 

 

1,573

 

Total

 

6,185,395

 

 

 

5,290,221

 

 

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 March 31, 2022, there are no preferred shares issued.

 

14


TCR2 Therapeutics Inc.

Notes to Unaudited Consolidated Financial Statements

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

 

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 three months ended March 31, 2022 and 2021.

 

 

As of March 31,

 

 

2022

 

 

2021

 

 Cash and cash equivalents

$

74,117

 

 

$

218,276

 

 Restricted cash

 

1,158

 

 

 

1,141

 

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

$

75,275

 

 

$

219,417

 

 

Segment information

 

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one consolidated operating segment.

 

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 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.

 

4. Investments and Fair Value Measurements

 

As of March 31, 2022, investments were comprised of the following:

 

 

 

Amortized
Cost

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair
Value

 

U.S. Treasury securities

 

$

158,415

 

 

$

-

 

 

$

(344

)

 

$

158,071

 

 

As of December 31, 2021, investments were comprised of the following:

 

 

 

Amortized
Cost

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair
Value

 

Corporate bonds

 

$

33,048

 

 

$

-

 

 

$

(11

)

 

$

33,037

 

U.S. Treasury securities

 

 

9,994

 

 

 

-

 

 

 

(2

)

 

 

9,992

 

Total

 

$

43,042

 

 

$

-

 

 

$

(13

)

 

$

43,029

 

 

Investments in corporate bonds are in accordance with our corporate investment policy which requires investment in Investment Grade Bonds as defined by the three major bond-ratings agency.

 

The amortized cost and estimated fair value of marketable securities, by contractual maturity:

 

 

 

 

 

 

 

March 31, 2022

 

 

 

 

 

 

 

Amortized
Cost

 

 

Fair Value

 

Due within one year or less

 

 

 

 

 

$

158,415

 

 

$

158,071

 

 

15


TCR2 Therapeutics Inc.

Notes to Unaudited Consolidated Financial Statements

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

 

 

 

 

 

 

 

 

December 31, 2021

 

 

 

 

 

 

 

Amortized
Cost

 

 

Fair Value

 

Due within one year or less

 

 

 

 

 

$

43,042

 

 

$

43,029

 

 

The Company follows FASB’s accounting guidance on fair value measurements for financial assets and liabilities measured on a recurring basis. Fair value is defined as the price at which an asset could be exchanged in a current transaction between knowledgeable, willing parties. Where available, fair value is based on observable market prices, or parameters derived from such prices. Where observable prices or inputs are not available, valuation models are applied. This hierarchy requires the use of observable market data when available and to minimize the use of unobservable inputs when determining fair value. These valuation techniques involve some level of management estimation and judgment. The degree of management estimation and judgment is dependent on the price transparency for the instruments, or market, and the instruments’ complexity.

 

The guidance requires fair value measurements to be classified and disclosed in one of the following three categories:

 

Level 1—Quoted prices (unadjusted in active markets for identical assets or liabilities)

Level 2—Inputs other than quoted prices in active markets that are observable either directly or indirectly

Level 3—Unobservable inputs in which there is little or no market data, which require the Company to develop its own assumptions

 

As of March 31, 2022, the Company has classified assets measured at fair value on a recurring basis as follows:

 

 

 

 

 

 

 

 

 

Fair Value Measurement Based on

 

 

 

Amortized

 

 

 

 

 

Quoted
Prices in
Active
Market

 

 

Significant
Other
Observable
Inputs

 

 

Significant
Unobservable
Inputs

 

 

 

Cost

 

 

Fair Value

 

 

(Level 1)

 

 

(Level 2)

 

 

(Level 3)

 

Cash equivalents (1)

 

$

69,896

 

 

$

69,896

 

 

$

69,896

 

 

$

-

 

 

$

-

 

U.S. Treasury securities

 

 

158,415

 

 

 

158,071

 

 

 

-

 

 

 

158,071

 

 

 

-

 

Total

 

$

228,311

 

 

$

227,967

 

 

$

69,896

 

 

$

158,071

 

 

$

-

 

 

As of December 31, 2021, the Company has classified assets measured at fair value on a recurring basis as follows:

 

 

 

 

 

 

 

 

 

Fair Value Measurement Based on

 

 

 

Amortized

 

 

 

 

 

Quoted
Prices in
Active
Market

 

 

Significant
Other
Observable
Inputs

 

 

Significant
Unobservable
Inputs

 

 

 

Cost

 

 

Fair Value

 

 

(Level 1)

 

 

(Level 2)

 

 

(Level 3)

 

Cash equivalents (1)

 

$

219,162

 

 

$

219,162

 

 

$

219,162

 

 

$

-

 

 

$

-