10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended September 30, 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: 001-40603

 

TSCAN THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

 

82-5282075

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer
Identification No.)

830 Winter Street,

Waltham, Massachusetts

 

02451

(Address of principal executive offices)

 

(Zip Code)

 

(857) 399-9500

(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

Voting Common Stock, $0.0001 par value per share

 

 

TCRX

 

The Nasdaq Global Market, LLC

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for 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, a 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 Exchange Act). Yes No ☒

As of November 4, 2022, the registrant had 18,936,440 shares of voting common stock, $0.0001 par value per share, and 5,143,134 shares of non-voting common stock, $0.0001 par value per share, outstanding.

 

 

 


 

Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

4

Item 1.

Financial Statements (Unaudited)

4

 

Condensed Consolidated Balance Sheets

4

 

Condensed Consolidated Statements of Operations

5

 

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Deficit

6

 

Condensed Consolidated Statements of Cash Flows

7

 

Notes to Unaudited Condensed Consolidated Financial Statements

8

Item 2.

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

14

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

21

Item 4.

Controls and Procedures

21

PART II.

OTHER INFORMATION

23

Item 1.

Legal Proceedings

23

Item 1A.

Risk Factors

23

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

85

Item 3.

Defaults Upon Senior Securities

85

Item 4.

Mine Safety Disclosures

85

Item 5.

Other Information

85

Item 6.

Exhibits

86

Signatures

87

 

1


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Quarterly Report are forward-looking statements.

In some cases, you can identify forward-looking statements by words such as “may,” “can,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “seek,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “possible” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements contained in this Quarterly Report include, but are not limited to, statements about:

• the beneficial characteristics, safety, efficacy, therapeutic effects and potential advantages of our T cell receptor-engineered T cell, or TCR-T, therapy candidates;

• our expectations regarding our preclinical studies being predictive of clinical trial results;

• the timing of the initiation, progress and expected results of our preclinical studies, clinical trials and our research and development programs;

• the timing of and our ability to submit applications for, and obtain and, if approved, maintain regulatory approvals for our product candidates;

• our plans relating to developing and commercializing our TCR-T therapy candidates, if approved, including sales strategy;

• estimates of the size of the addressable market for our TCR-T therapy candidates;

• our manufacturing capabilities and the scalable nature of our manufacturing process;

• our estimates regarding expenses, future milestone payments and revenue, capital requirements and needs for additional financing;

• our expectations regarding competition;

• our anticipated growth strategies;

• our ability to attract or retain key personnel;

• our ability to establish and maintain development partnerships and collaborations;

• our expectations regarding federal, state and foreign regulatory requirements;

• regulatory developments in the United States and foreign countries;

• our ability to obtain and maintain intellectual property protection for our proprietary platform technology and our product candidates;

• the anticipated trends and challenges in our business and the market in which we operate;

• the sufficiency of our existing capital resources to fund our future operating expenses and capital expenditure requirements;

• the effects of health epidemics, including the evolving effects of the COVID-19 pandemic, in regions where we, our partners, or other third parties on which we rely, on any of the foregoing or other aspects of our business or operations;

• the effects of rising inflation rates and the impact on operating costs, liquidity and access to credit on any of the foregoing or other aspects of our business operations;

• the effects of global economic uncertainty and financial market volatility caused by political instability, changes in international trade relationships and conflicts, such as the ongoing conflict between Russia and Ukraine, on any of the foregoing or other aspects of our business or operations; and

• our anticipated use of our existing cash resources and our ability to obtain additional financing in the future.

2


 

Any forward-looking statements in this Quarterly Report reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. These forward-looking statements are subject to a number of risks, uncertainties and assumptions included in this Quarterly Report, particularly those described in the “Risk Factors” section in Part II, Item 1A of this Quarterly Report, that could cause actual results or events to differ materially from the forward-looking statements that we make. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time and it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. In light of these risks, uncertainties and assumptions, the forward- looking events and circumstances discussed in this Quarterly Report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements contained in this Quarterly Report are made as of the date of this Quarterly Report, and although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, advancements, discoveries, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. Except as required by law, we assume no obligation to update or revise these any forward-looking statements for any reason even if new information becomes available in the future.

You should read this Quarterly Report and the documents that we have filed as an exhibit to this Quarterly Report with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect.

In addition, this Quarterly Report contains estimates, projections and other information concerning our industry, our business and the markets for our product candidates, including data regarding the estimated size of such markets and the incidence of certain medical conditions. We obtained the industry, market and similar data set forth in this Quarterly Report from our internal estimates and research, and from academic and industry research, publications, surveys and studies conducted by third parties, including governmental agencies. Industry publications and third party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable. Our estimates of the potential market opportunities for our product candidates include a number of key assumptions based on our industry knowledge, industry publications and third party research, surveys and studies, which may be based on a small sample size and fail to accurately reflect market opportunities. Information based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by us and third parties, industry, medical and general publications, government data and similar sources. This Quarterly Report contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents.

Unless stated otherwise, references in this Quarterly Report to “us,” “we,” “our,” “our Company,” or “the Company” and similar terms refer to TScan Therapeutics, Inc.

3


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

TScan Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

(Unaudited)

 

 

 

September 30,
2022

 

 

December 31,
2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

137,306

 

 

$

161,405

 

Prepaid expenses and other current assets

 

 

3,871

 

 

 

4,249

 

Total current assets

 

 

141,177

 

 

 

165,654

 

Property and equipment, net

 

 

10,334

 

 

 

11,765

 

Right-of-use assets

 

 

4,368

 

 

 

5,491

 

Prepaid rent

 

 

3,759

 

 

 

-

 

Restricted cash

 

 

5,037

 

 

 

5,031

 

Long-term deposits and other assets

 

 

779

 

 

 

166

 

Total assets

 

$

165,454

 

 

$

188,107

 

 

 

 

 

 

 

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

2,708

 

 

$

1,765

 

Accrued expenses and other current liabilities

 

 

6,159

 

 

 

6,517

 

Operating lease liability, current portion

 

 

1,795

 

 

 

1,651

 

Deferred revenue, current portion

 

 

5,932

 

 

 

11,410

 

Total current liabilities

 

 

16,594

 

 

 

21,343

 

Deferred revenue, net of current portion

 

 

-

 

 

 

1,497

 

Operating lease liability, net of current portion

 

 

3,031

 

 

 

4,392

 

Long-term debt and accrued interest

 

 

29,074

 

 

 

-

 

Other long-term liabilities

 

 

97

 

 

 

97

 

Total liabilities

 

 

48,796

 

 

 

27,329

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 5)

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding

 

 

-

 

 

 

-

 

Voting common stock, $0.0001 par value; 300,000,000 shares authorized; 18,931,793 and 18,881,333 shares issued; and 18,931,793 and 18,764,463 shares outstanding at September 30, 2022 and December 31, 2021, respectively

 

 

2

 

 

 

2

 

Non-voting common stock, $0.0001 par value; 10,000,000 shares authorized; 5,143,134 shares issued and outstanding

 

 

1

 

 

 

1

 

Additional paid-in capital

 

 

256,311

 

 

 

252,933

 

Accumulated deficit

 

 

(139,656

)

 

 

(92,158

)

Total stockholders' equity

 

 

116,658

 

 

 

160,778

 

Total liabilities and stockholders' equity

 

$

165,454

 

 

$

188,107

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

4


 

TScan Therapeutics, Inc.

Condensed Consolidated Statements of Operations

(in thousands, except share and per share data)

(Unaudited)

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration and license revenue

 

$

3,363

 

 

$

2,412

 

 

$

10,440

 

 

$

7,287

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

15,031

 

 

 

14,206

 

 

 

44,215

 

 

 

32,346

 

General and administrative

 

 

4,910

 

 

 

4,048

 

 

 

14,212

 

 

 

9,380

 

Total operating expenses

 

 

19,941

 

 

 

18,254

 

 

 

58,427

 

 

 

41,726

 

Loss from operations

 

 

(16,578

)

 

 

(15,842

)

 

 

(47,987

)

 

 

(34,439

)

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other income, net

 

 

534

 

 

 

3

 

 

 

690

 

 

 

14

 

Interest expense

 

 

(201

)

 

 

-

 

 

 

(201

)

 

 

-

 

Net loss

 

$

(16,245

)

 

$

(15,839

)

 

$

(47,498

)

 

$

(34,425

)

Net loss attributable to common stockholders

 

$

(16,245

)

 

$

(15,839

)

 

$

(47,498

)

 

$

(34,425

)

Net loss per share, basic and diluted

 

$

(0.67

)

 

$

(0.80

)

 

$

(1.98

)

 

$

(4.55

)

Weighted average common shares outstanding—basic and diluted

 

 

24,073,935

 

 

 

19,875,428

 

 

 

24,038,257

 

 

 

7,562,436

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

5


 

TScan Therapeutics, Inc.

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(in thousands, except share data)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

Total

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Non-voting Common Stock

 

 

Paid-In

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity (Deficit)

 

Balances at June 30, 2021

 

 

15,616,272

 

 

$

159,411

 

 

 

 

1,419,819

 

 

$

1

 

 

 

-

 

 

$

-

 

 

$

2,088

 

 

$

(62,119

)

 

$

(60,030

)

Issuance of common stock, net of issuance costs of $10,400

 

 

 

 

 

 

 

 

 

6,666,667

 

 

 

1

 

 

 

 

 

 

 

 

 

89,646

 

 

 

 

 

 

89,647

 

Conversion of convertible preferred stock to common stock upon closing of initial public offering

 

 

(15,616,272

)

 

 

(159,411

)

 

 

 

10,473,138

 

 

 

-

 

 

 

5,143,134

 

 

 

1

 

 

 

159,410

 

 

 

-

 

 

 

159,411

 

Vesting of restricted common stock

 

 

-

 

 

 

-

 

 

 

 

58,463

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

885

 

 

 

-

 

 

 

885

 

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(15,839

)

 

 

(15,839

)

Balances at September 30, 2021

 

 

-

 

 

$

-

 

 

 

 

18,618,087

 

 

$

2

 

 

 

5,143,134

 

 

$

1

 

 

$

252,029

 

 

$

(77,958

)

 

$

174,074

 

Balances at June 30, 2022

 

 

-

 

 

$

-

 

 

 

 

18,929,834

 

 

$

2

 

 

 

5,143,134

 

 

$

1

 

 

$

255,060

 

 

$

(123,411

)

 

$

131,652

 

Exercise of stock options

 

 

-

 

 

 

-

 

 

 

 

1,959

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

5

 

 

 

-

 

 

 

5

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,246

 

 

 

-

 

 

 

1,246

 

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(16,245

)

 

 

(16,245

)

Balances at September 30, 2022

 

 

-

 

 

$

-

 

 

 

 

18,931,793

 

 

$

2

 

 

 

5,143,134

 

 

$

1

 

 

$

256,311

 

 

$

(139,656

)

 

$

116,658

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

Total

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Non-voting Common Stock

 

 

Paid-In

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity (Deficit)

 

Balances at January 1, 2021

 

 

7,063,104

 

 

$

59,681

 

 

 

 

1,135,858

 

 

$

1

 

 

 

-

 

 

$

-

 

 

$

1,070

 

 

$

(43,533

)

 

$

(42,462

)

Issuance of Series C convertible preferred stock (net of issuance costs of $270)

 

 

8,553,168

 

 

 

99,730

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Issuance of common stock, net of issuance costs of $10,400

 

 

-

 

 

 

-

 

 

 

 

6,666,667

 

 

 

1

 

 

 

-

 

 

 

-

 

 

 

89,646

 

 

 

-

 

 

 

89,647

 

Conversion of convertible preferred stock to common stock upon closing of initial public offering

 

 

(15,616,272

)

 

 

(159,411

)

 

 

 

10,473,138

 

 

 

-

 

 

 

5,143,134

 

 

 

1

 

 

 

159,410

 

 

 

-

 

 

 

159,411

 

Exercise of stock options

 

 

-

 

 

 

-

 

 

 

 

108,657

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

171

 

 

 

-

 

 

 

171

 

Vesting of restricted common stock

 

 

-

 

 

 

-

 

 

 

 

233,767

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,732

 

 

 

-

 

 

 

1,732

 

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(34,425

)

 

 

(34,425

)

Balances at September 30, 2021

 

 

-

 

 

$

-

 

 

 

 

18,618,087

 

 

$

2

 

 

 

5,143,134

 

 

$

1

 

 

$

252,029

 

 

$

(77,958

)

 

$

174,074

 

Balances at January 1, 2022

 

 

-

 

 

$

-

 

 

 

 

18,764,463

 

 

$

2

 

 

 

5,143,134

 

 

$

1

 

 

$

252,933

 

 

$

(92,158

)

 

$

160,778

 

Exercise of stock options

 

 

-

 

 

 

-

 

 

 

 

50,460

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

124

 

 

 

-

 

 

 

124

 

Vesting of restricted common stock

 

 

-

 

 

 

-

 

 

 

 

116,870

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

3,254

 

 

 

-

 

 

 

3,254

 

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(47,498

)

 

 

(47,498

)

Balances at September 30, 2022

 

 

-

 

 

$

-

 

 

 

 

18,931,793