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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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, 2020

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: 001-38052

 

FORTE BIOSCIENCES, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

26-1243872

(State or other jurisdiction of

incorporation or organization)

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

1124 W Carson Street

MRL Building 3-320

Torrance, California

90502

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (310) 618-6994

 

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

 

FBRX

 

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 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, 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 3, 2020, the registrant had 12,830,598 shares of common stock, $0.001 par value per share, outstanding.

 

 

 

 


Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

2

Item 1.

Financial Statements

2

 

Condensed Consolidated Balance Sheets as of September 30, 2020 (unaudited) and December 31, 2019

2

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2020 and 2019 (unaudited)

3

 

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the Three and Nine Months Ended September 30, 2020 and 2019 (unaudited)

4

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2020 and 2019 (unaudited)

5

 

Notes to Unaudited Condensed Consolidated Financial Statements

6

Item 2.

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

16

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

22

Item 4.

Controls and Procedures

23

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

74

Item 3.

Defaults Upon Senior Securities

74

Item 4.

Mine Safety Disclosures

74

Item 5.

Other Information

74

Item 6.

Exhibits

75

SIGNATURES

76

 

 

 

1


PART I – FINANCIAL INFORMATION

Item 1: Financial Statements

FORTE BIOSCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and par value data)

 

 

 

September 30, 2020

 

 

December 31, 2019

 

 

 

 

(unaudited)

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

Cash

 

$

20,175

 

 

$

6,939

 

 

Prepaid expenses and other current assets

 

 

1,442

 

 

 

567

 

 

Total current assets

 

 

21,617

 

 

 

7,506

 

 

 

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

110

 

 

 

152

 

 

Other assets

 

 

1,003

 

 

 

-

 

 

Total assets

 

$

22,730

 

 

$

7,658

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities, convertible preferred stock and stockholders' equity (deficit)

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,513

 

 

$

1,569

 

 

Accrued liabilities

 

 

898

 

 

 

343

 

 

Total current liabilities

 

 

2,411

 

 

 

1,912

 

 

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 5)

 

 

 

 

 

 

 

 

 

Series A Convertible Preferred Stock, $0.001 par value; 10,000,000

shares authorized and 0 and 3,177,744 shares issued and outstanding as of

September 30, 2020 (unaudited) and December 31, 2019, respectively;     aggregate liquidation preference of $10,821 at December 31, 2019

 

 

-

 

 

 

10,515

 

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

 

 

 

Common stock, $0.001 par value: 200,000,000 shares authorized as of

September 30, 2020 (unaudited) and December 31, 2019; 11,216,563 and 2,108,266 shares issued and outstanding at September 30, 2020 (unaudited) and December 31, 2019, respectively

 

 

11

 

 

 

2

 

 

Additional paid-in capital

 

 

67,189

 

 

 

199

 

 

Accumulated deficit

 

 

(46,881

)

 

 

(4,970

)

 

Stockholders’ equity (deficit):

 

 

20,319

 

 

 

(4,769

)

 

Total liabilities, convertible preferred stock and stockholders’ equity (deficit)

 

$

22,730

 

 

$

7,658

 

 

 

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

2


FORTE BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

3,688

 

 

$

353

 

 

$

6,979

 

 

$

1,526

 

General and administrative

 

 

1,320

 

 

 

331

 

 

 

2,753

 

 

 

974

 

In process research and development assets acquired

 

 

-

 

 

 

-

 

 

 

32,057

 

 

 

-

 

Total operating expenses

 

 

5,008

 

 

 

684

 

 

 

41,789

 

 

 

2,500

 

Loss from operations

 

 

(5,008

)

 

 

(684

)

 

 

(41,789

)

 

 

(2,500

)

Other income (expenses)

 

 

(92

)

 

 

(6

)

 

 

(122

)

 

 

(5

)

Net loss

 

$

(5,100

)

 

$

(690

)

 

$

(41,911

)

 

$

(2,505

)

Per share information:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share - basic and diluted

 

$

(0.45

)

 

$

(0.33

)

 

$

(7.36

)

 

$

(1.19

)

Weighted average shares outstanding, basic and diluted

 

 

11,209,052

 

 

 

2,108,266

 

 

 

5,691,587

 

 

 

2,108,266

 

 

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

 

 

3


FORTE BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)

(unaudited)

(in thousands, except share data)

 

 

 

Series A

 

 

 

 

 

 

Additional

 

 

 

 

 

 

Total

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Paid-in

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity (Deficit)

 

Balance — December 31, 2018

 

 

1,738,759

 

 

$

5,659

 

 

 

 

2,108,266

 

 

$

2

 

 

$

163

 

 

$

(901

)

 

$

(736

)

Issuance of Series A convertible preferred stock, net of issuance cost of $44

 

 

1,438,985

 

 

 

4,856

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Stock based compensation

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

2

 

 

 

-

 

 

 

2

 

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1,185

)

 

 

(1,185

)

Balance — March 31, 2019

 

 

3,177,744

 

 

 

10,515

 

 

 

 

2,108,266

 

 

 

2

 

 

 

165

 

 

 

(2,086

)

 

 

(1,919

)

Stock based compensation

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

1

 

 

 

-

 

 

 

1

 

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(630

)

 

 

(630

)

Balance — June 30, 2019

 

 

3,177,744

 

 

 

10,515

 

 

 

 

2,108,266

 

 

 

2

 

 

 

166

 

 

 

(2,716

)

 

 

(2,548

)

Stock based compensation

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

2

 

 

 

-

 

 

 

2

 

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(690

)

 

 

(690

)

Balance — September 30, 2019

 

 

3,177,744

 

 

$

10,515

 

 

 

 

2,108,266

 

 

$

2

 

 

$

168

 

 

$

(3,406

)

 

$

(3,236

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance — December 31, 2019

 

 

3,177,744

 

 

$

10,515

 

 

 

 

2,108,266

 

 

$

2

 

 

$

199

 

 

$

(4,970

)

 

$

(4,769

)

Exercise of employee stock options

 

 

-

 

 

 

-

 

 

 

 

52,706

 

 

 

-

 

 

 

45

 

 

 

-

 

 

 

45

 

Stock based compensation

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

2

 

 

 

-

 

 

 

2

 

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(2,050

)

 

 

(2,050

)

Balance — March 31, 2020

 

 

3,177,744

 

 

 

10,515

 

 

 

 

2,160,972

 

 

 

2

 

 

 

246

 

 

 

(7,020

)

 

$

(6,772

)

Conversion of preferred stocks into common stock

 

 

(3,177,744

)

 

 

(10,515

)

 

 

 

3,177,744

 

 

 

3

 

 

 

10,512

 

 

 

-

 

 

 

10,515

 

Sale of common stock, net of issuance costs of $43

 

 

 

 

 

 

 

 

 

 

 

4,215,929

 

 

 

4

 

 

 

24,012

 

 

 

-

 

 

 

24,016

 

Issuance of common stock in connection with reverse merger

 

 

-

 

 

 

-

 

 

 

 

1,656,076

 

 

 

2

 

 

 

31,807

 

 

 

-

 

 

 

31,809

 

Restricted stock awards withholdings for taxes

 

 

-

 

 

 

-

 

 

 

 

(16,294

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Exercise of employee stock options

 

 

-

 

 

 

-

 

 

 

 

3,888

 

 

 

-

 

 

 

47

 

 

 

-

 

 

 

47

 

Stock based compensation

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

24

 

 

 

-

 

 

 

24

 

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(34,761

)

 

 

(34,761

)

Balance — June 30, 2020

 

 

-

 

 

 

-

 

 

 

 

11,198,315

 

 

 

11

 

 

 

66,648

 

 

 

(41,781

)

 

 

24,878

 

Exercise of employee stock options

 

 

-

 

 

 

-

 

 

 

 

18,248

 

 

 

-

 

 

 

166

 

 

 

-

 

 

 

166

 

Stock based compensation

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

375

 

 

 

-

 

 

 

375

 

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(5,100

)

 

 

(5,100

)

Balance — September 30, 2020

 

 

-

 

 

 

-

 

 

 

 

11,216,563

 

 

$

11

 

 

$

67,189

 

 

$

(46,881

)

 

$

20,319

 

 

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

 

 

4


FORTE BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

 

 

 

Nine Months Ended

 

 

 

September 30, 2020

 

 

September 30, 2019

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(41,911

)

 

$

(2,505

)

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

 

 

 

 

 

 

 

 

In process research and development acquired

 

 

30,885

 

 

 

-

 

Depreciation expense

 

 

40

 

 

 

-

 

Stock based compensation expense

 

 

401

 

 

 

5

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

(322

)

 

 

36

 

Accounts payable

 

 

(394

)

 

 

232

 

Accrued liabilities

 

 

(3,319

)

 

 

114

 

Net cash used in operating activities

 

 

(14,620

)

 

 

(2,118

)

 

 

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Cash and restricted cash acquired in reverse merger

 

 

3,582

 

 

 

-

 

Purchase of property and equipment

 

 

-

 

 

 

(73

)

Net cash provided by (used in) investing activities

 

 

3,582

 

 

 

(73

)

 

 

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock, net of

   issuance costs

 

 

24,016

 

 

 

-

 

Proceeds from issuance of convertible preferred stock, net of

   issuance costs

 

 

-

 

 

 

4,856

 

Proceeds from exercise of employee stock options

 

 

258

 

 

 

-

 

Net cash provided by financing activities

 

 

24,274

 

 

 

4,856

 

Net increase in cash

 

 

13,236

 

 

 

2,665

 

Cash — beginning of period

 

 

6,939

 

 

 

5,016

 

Cash — end of period

 

$

20,175

 

 

$

7,681

 

Supplemental disclosure of non-cash investing and financing activities:

 

 

 

 

 

 

 

 

Conversion of preferred stock to common stock

 

$

10,515

 

 

$

-

 

Issuance of common stock to Tocagen shareholders

 

$

31,809

 

 

$

-

 

Unpaid offering costs

 

$

297

 

 

$

-

 

 

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

 

 

 

 

5


FORTE BIOSCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

1. Organization and Description of Business

 

Forte Biosciences, Inc. (www.fortebiorx.com), together with its subsidiary referred to herein as the “Company”, is a clinical-stage biopharmaceutical company focused on advancing its clinical program and developing a live biotherapeutic for the treatment of inflammatory skin diseases, particularly for pediatric atopic dermatitis patients for which there is currently a significant unmet need for safe and effective therapies. The Company entered into a business combination (“Merger”) between Forte Subsidiary, Inc. (“Forte Subsidiary”) a private entity, and Tocagen, Inc. (“Tocagen”), a publicly traded biotechnology company. The Merger closed on June 15, 2020, in which Telluride Merger Sub, Inc., a wholly-owned subsidiary of Tocagen, merged with and into Forte Subsidiary, with Forte Subsidiary surviving the Merger as a wholly-owned subsidiary of Tocagen. Immediately prior to the closing of the Merger, the shares of Tocagen common stock were adjusted with a reverse split ratio of 1‑for‑15. At the closing of the Merger, each share of Forte Subsidiary common stock outstanding immediately prior to the Merger was converted into the right to receive approximately 3.1624 shares of Tocagen common stock (before giving effect to the reverse split).  All share and per share amounts have been retrospectively adjusted to give effect to the exchange of Forte Subsidiary common stock and the reverse split of Tocagen common stock. The par value per share of our capital stock was not adjusted as a result of the stock split. Immediately prior to the closing of the Merger, Tocagen changed its name to Forte Biosciences, Inc. The Company’s common stock is traded on the Nasdaq stock exchange under the ticker symbol “FBRX.” Immediately following the Merger, the former Forte Subsidiary and Tocagen security holders owned approximately 84.7% and 15.3% of the number of shares of the Company’s common stock, respectively.

 

Prior to the Merger, Forte Subsidiary was incorporated as Forte Biosciences, Inc. under the laws of the State of Delaware on May 3, 2017 as a privately-held company.  Forte Biosciences, Inc. was renamed Forte Subsidiary, Inc. in connection with the Merger.

 

The Merger was accounted for as a reverse asset acquisition. Forte Subsidiary is deemed to be the acquirer for accounting purposes and Tocagen the accounting acquiree (Note 4). Accordingly, for accounting purposes: (i) the merger was treated as the equivalent of Forte Subsidiary issuing stock to acquire the net assets of Tocagen, (ii) the transaction price was allocated over the acquired Tocagen net assets based upon their relative fair value at the time of closing, (iii) the reported historical operating results of the combined company prior to the merger will be those of Forte Subsidiary and not of Tocagen, and (iv) for periods prior to the transaction, shareholders’ authorized capital of the combined company is presented based on the historical authorized capital of Tocagen.

 

Liquidity and Risks

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. Since inception, the Company has incurred losses and negative cash flows from operations. As of September 30, 2020, the Company had an accumulated deficit of $46.9 million, which includes a charge of $32.1 million for acquired in-process research and development assets in connection with the Merger. The Company used $14.6 million of cash in operating activities during the nine months ended September 30, 2020. Management expects to continue to incur additional substantial losses in the foreseeable future as a result of the Company’s research and development activities.

 

The Company had cash of approximately $20.2 million as of September 30, 2020. The Company believes that its existing cash, additional capital from the ATM Facility (see Note 7) and the recent underwritten public offering on November 2, 2020 which raised net proceeds of approximately $43.0 million after deducting underwriting discounts and commissions and before other offering expenses (see Note 9), will be sufficient to allow the Company to fund its operations for at least 12 months from the filing date of this Form 10-Q. 

6


 

The Company will continue to need to raise additional capital or obtain financing from other sources. Management may fund future operations through the sale of equity and debt financings and may also seek additional capital through arrangements with strategic partners or other sources. There can be no assurance that additional funding will be available on terms acceptable to the Company, if at all. If the Company is unable to raise additional funding to meet its working capital needs in the future, it will be forced to delay or reduce the scope of its research and development programs and/or limit or cease its operations.

Because of the numerous risks and uncertainties associated with pharmaceutical development, the Company is unable to predict the timing or amount of increased expenses or when or if it will start to generate revenues. Even if the Company is able to generate revenues, it may not be able to achieve or maintain profitability. If the Company fails to become profitable or is unable to sustain profitability on a continuing basis, then it may be unable to continue its operations at planned levels and may be forced to reduce its operations.

 

The pandemic caused by an outbreak of a new strain of coronavirus, or COVID-19, has resulted, and is likely to continue to result, in significant national and global economic disruption and may adversely affect the Company’s operations. The Company is actively monitoring the impact of COVID-19 and the possible effects on its financial condition, liquidity, operations, suppliers, industry, and workforce. However, the full extent, consequences, and duration of the COVID-19 pandemic and the resulting impact on the Company cannot currently be predicted. The Company will continue to evaluate the impact that these events could have on its operations, financial position, results of operations and cash flows during fiscal year 2020.

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements of the Company should be read in conjunction with Forte Subsidiary’s audited financial statements and accompanying notes thereto as of and for the year ended December 31, 2019 included in Tocagen’s Registration Statement on Form S-4 (Registration No. 333-237371) as filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 25, 2020, as amended and declared effective by the SEC on May 13, 2020. The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim condensed consolidated financial statements. Any reference in the Notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).

The Merger (Note 1) was accounted for as a reverse asset acquisition. Forte Subsidiary is deemed to be the acquirer for accounting purposes (Note 4) and Tocagen is the accounting acquiree. Accordingly, for accounting purposes: (i) the merger will be treated as the equivalent of Forte Subsidiary issuing stock to acquire the net assets of Tocagen, (ii) the transaction price will be allocated over the acquired Tocagen net assets based upon their relative fair value at the time of closing, (iii) the reported historical operating results of the combined company prior to the merger will be those of Forte Subsidiary and not of Tocagen, and (iv) for periods prior to the transaction, shareholders’ authorized capital of the combined company is presented based on the historical authorized capital of Tocagen.

In the opinion of management, the accompanying condensed consolidated financial statements include all adjustments that are of a normal and recurring nature and that are necessary for the fair presentation of the Company’s financial position, the results of its operations and cash flows for the periods presented. Interim results are not necessarily indicative of results for the full year or any future period.

Principles of Consolidation

The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Forte Subsidiary, Inc. All intercompany accounts and transactions have been eliminated in the preparation of the condensed consolidated financial statements.

7


Use of Estimates

The preparation of the Company’s financial statements requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in the Company’s financial statements and accompanying notes. Significant management estimates that affect the reported amounts of assets and liabilities include useful lives of property and equipment, stock-based compensation, accruals for clinical trials and deferred tax assets. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions.

 

Acquired In-Process Research and Development Expense

The Company acquired in-process research and development assets in connection with its Merger with Tocagen. As the acquired in-process research and development assets were deemed to have no current or alternative future use, an expense of $32.1 million was recognized in the condensed consolidated statements of operations for the nine months ended September 30, 2020.

Impairment of Long-Lived Assets

The Company reviews long-lived assets for impairment when events or changes in circumstances indicate the carrying value of the assets may not be recoverable. Recoverability is measured by comparing the book values of the assets to future net undiscounted cash flows that the assets or the asset groups are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceed their fair value, which is measured based on the estimated discounted future net cash flows arising from the assets or asset groups. No impairment losses on long-lived assets have been recorded through September 30, 2020.

 

Comprehensive Loss

Comprehensive loss includes net loss and other comprehensive income (loss) for the period. The Company did not have other comprehensive income (loss) items such as unrealized gains and losses. For the three and nine months ended September 30, 2020 and 2019, comprehensive loss was equal to the net loss.

 

Net Loss Per Share

Basic net loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period, without consideration for common stock equivalents.

Diluted net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock and common stock equivalents outstanding during the period. The following number of unexercised stock options, convertible preferred stock and warrants, which are common stock equivalents, have been excluded from the diluted net loss calculation as their effect would have been anti-dilutive for all periods presented:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Options

 

 

1,038,496

 

 

 

516,521

 

 

 

1,038,496

 

 

 

516,521

 

Convertible preferred stock

 

-

 

 

 

3,177,744

 

 

 

-

 

 

 

3,177,744

 

Warrants

 

 

2,756,980

 

 

 

-

 

 

 

2,756,980

 

 

 

-

 

Total

 

 

3,795,476

 

 

 

3,694,265

 

 

 

3,795,476

 

 

 

3,694,265

 

8


Recently Adopted Accounting Standards

In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses, which changes the accounting for recognizing impairments of financial assets. Under the new guidance, credit losses for certain types of financial instruments will be estimated based on expected losses. The new guidance also modifies the impairment models for available-for-sale debt securities and for purchased financial assets with credit deterioration since their origination. The Company adopted this ASU on January 1, 2020. The adoption of this amended guidance did not have a material effect on the Company’s condensed consolidated financial statements.  

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (“ASC 820”). The new guidance removes, modifies and adds to certain disclosure requirements on fair value measurements in ASC 820. The Company adopted this ASU on January 1, 2020. The adoption of this amended guidance did not have a material effect on the Company’s condensed consolidated financial statements.  

Recently Issued Accounting Standards

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by us as of a specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations.

In December 2019, the FASB issued ASU 2019-12, Income Taxes (“ASC 740”), which simplifies the accounting for income taxes by eliminating certain exceptions to the guidance in ASC 740 related to the approach for intra-period tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. The guidance is effective for calendar-year public business entities in 2021 and interim periods within that year. Early adoption is permitted. The Company does not expect adoption of this new guidance will have a material impact on its financial position or results of operations.

In August 2020, the FASB issued ​ASU 2020-06​, ​Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in an Entity’s Own Equity (Subtopic 815-40)​ (“ASU 2020-06”). ​ASU 2020-06 eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, ASU 2020-06 modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted earnings per share computation. The amendments in ASU 2020-06 are effective for smaller reporting companies as defined by the SEC for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but not earlier than fiscal years beginning after December 15, 2020. The Company is currently evaluating the impact of ASU 2020-06 on its financial statements and does not expect the adoption of this ASU to have a material impact on the Company’s consolidated financial statements.

9


3. Balance Sheet Components

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets as of September 30, 2020 and December 31, 2019 consist of the following (in thousands):

 

 

 

September 30, 2020

(unaudited)

 

 

December 31,

2019

 

Prepaid insurance

 

$

443

 

 

$

30

 

Prepaid manufacturing expenses

 

 

286

 

 

 

514

 

Deposits for manufacturing components

 

 

249

 

 

 

 

Offering costs

 

 

297

 

 

 

 

Other

 

 

167

 

 

 

23

 

Total Prepaid Expenses and Other Current Assets

 

$

1,442

 

 

$

567

 

Accrued Liabilities

Accrued liabilities, as of September 30, 2020 and December 31, 2019 consist of the following (in thousands):

 

 

 

September 30, 2020

(unaudited)

 

 

December 31,

2019

 

Accrued legal and professional fees

 

$

152

 

 

$

168

 

Accrued manufacturing and clinical expenses

 

 

188

 

 

 

 

Accrued compensation

 

 

434

 

 

 

175

 

Accrued franchise taxes

 

 

43

 

 

 

 

Accrued other expenses

 

 

81

 

 

 

 

Total Accrued Liabilities

 

$

898

 

 

$

343

 

 

4. Merger

On June 15, 2020, the Company completed the Merger (see Note 1). The Merger was accounted for as a reverse asset acquisition as Tocagen did not meet the definition of a business pursuant to Topic 805, Business Combinations, as Tocagen did not have the ability to create output, and substantially all of its fair value was concentrated in cash and in-process research and development (“IPR&D”) assets. Forte Subsidiary is deemed to be the acquirer for accounting purposes as immediately following the merger: (i) Forte Subsidiary stockholders owned a substantial majority of the voting rights of the combined company; (ii) Forte Subsidiary designated a majority of the initial members of the board of directors of the combined company; and (iii) Forte Subsidiary’s senior management held all key positions of the combined company and no employees were retained from Tocagen. Accordingly, for accounting purposes: (i) the merger has been treated as the equivalent of Forte Subsidiary issuing stock to acquire the net assets of Tocagen, (ii) the transaction price has been allocated over the acquired Tocagen net assets based upon their relative fair value at the time of closing, (iii) the reported historical operating results of the combined company prior to the merger are those of Forte Subsidiary, and (iv) for periods prior to the transaction, shareholders’ authorized capital of the combined company is presented based on the historical authorized capital of Tocagen.

10


The following summarizes the estimated fair value of the assets and liabilities acquired at June 15, 2020, the date of the Merger (in thousands):

 

Cash

 

$

2,997

 

Restricted cash

 

 

586

 

Prepaid and other assets

 

 

1,257

 

In-process research and development

 

 

32,057

 

Accounts payable and accrued expenses assumed

 

 

(3,916

)

Purchase price

 

$

32,981

 

 

The estimated fair value of total consideration given was $33.0 million based on 1,594,670 shares of Tocagen common stock, 61,406 vested restricted stock awards and in-the-money options to purchase 26,975 shares of common stock of Tocagen outstanding immediately prior to the merger date, multiplied by the Tocagen closing stock price of $18.90 on the date of the merger, and transaction costs of approximately $1.2 million. The fair value of the IPR&D assets is expensed as a charge in the condensed consolidated statements of operations for the nine months ended September 30, 2020 as there is no alternative use to these assets.  

5. Commitments and Contingencies

Concentrations of Credit Risk

Bank accounts in the United States are insured by the Federal Deposit Insurance Corporation (FDIC) up to $250,000. The Company’s primary operating cash accounts significantly exceed FDIC limits.

Indemnifications

As permitted under Delaware law, the Company indemnifies its officers, directors, and employees for certain events and occurrences while the officer, or director is, or was, serving at the Company’s request in such capacity.

License to Patented Technology

In December 2017, the Company entered into an exclusive license agreement with the Department of Health and Human Services (“DHHS”). Under the agreement, the DHHS granted the Company an exclusive, sublicensable, worldwide license to certain patent rights under which the Company may develop and commercialize pharmaceutical and biological compositions comprising Gram-negative bacteria for the topical treatment of dermatological diseases and conditions (the “DHHS License”). Under the DHHS License, the Company is obligated to meet certain development benchmarks within certain time periods. If the Company is unable to meet any of these development benchmarks, the DHHS could terminate the license. In addition, the DHHS may terminate or modify the DHHS License in the event of a material breach or upon certain insolvency events that remain uncured following a 90 days written notice of such material breach or insolvency event. The DHHS also has the right to require the Company to grant mandatory sublicenses to patent rights licensed from the DHHS to product candidates covered by other DHHS licenses under certain specified circumstances, including if it is necessary to meet health and safety needs that the Company is not reasonably satisfying or if necessary to meet requirements for public use specified by federal regulations which the Company is not reasonably satisfying.

11


Under the DHHS License, as amended in May 2020, the Company is obligated to pay the DHHS a minimum annual payment of $20,000 for 2020, which will increase to $100,000 beginning January 1, 2021.  The Company is required to reimburse the DHHS for certain patent-related expenses. In addition, the Company may also be obligated to make milestone payments to the DHHS based on achieving specified development and regulatory milestones for the first licensed product. Such development milestone payments are the completion of patient enrollment in a phase 3 clinical trial and the completion of a phase 3 clinical trial demonstrating a statistically significant efficacy benefit. The regulatory milestones are the receipt of the first FDA approval and the first non-USA regulatory agency approval. In addition, to the extent licensed products are approved for commercial sale, the Company is also obligated to pay the DHHS royalties based on net sales of licensed products sold by the Company and if applicable, its sublicensees. No milestones have been met as of September 30, 2020.

The Company incurred $5,000 in minimum royalty expenses for each of the three months ended September 30, 2020 and 2019. The Company incurred $25,000 and $15,000 in minimum royalty expenses for the nine months ended September 30, 2020 and 2019, respectively.

Lease Agreement

In April 2019, the Company entered into a lease agreement for certain office and laboratory space in Torrance, California. The lease agreement is cancellable by the Company at any time with a 30-day notice.  The Company recorded total rent expenses of $5,000 and $8,000 for the three months ended September 30, 2020 and 2019, and $19,000 and $12,000 for the nine months ended September 30, 2020 and 2019, respectively.

 

Clinical Supply Agreements

The Company has entered into various product manufacturing and clinical supply agreements with Contract Manufacturing Organizations (“CMOs”) for the manufacture of clinical trial materials and Contract Research Organizations (“CROs”) for clinical trial services. The product manufacturing and clinical supply agreements provide the terms and conditions under which the CMOs and CROs will formulate, fill, inspect, package, label and test the Company’s drug product candidate, FB-401. The estimated remaining commitment as of September 30, 2020 under these agreements was approximately $110,000.

6. Equity

Series A Convertible Preferred Stock

On November 27, 2018, the Company entered into a preferred stock purchase agreement with certain investors and issued 1,738,759 shares of Series A convertible preferred stock for net proceeds of $5.7 million, including $0.7 million from the conversion of convertible notes and accrued interest. In addition, on January 2, 2019, the Company completed a second round of Series A preferred stock financing and issued 1,438,985 shares at $3.41 per share for net proceeds of $4.9 million. All outstanding shares of Series A convertible preferred stock were converted into shares of common stock on a one for one ratio in connection with the closing of the Merger on June 15, 2020.  

Common Stock

In connection with the Merger, the Company issued 3,804,817 shares of its common stock, and warrants to purchase 2,752,546 shares of the Company’s common stock at an exercise price of $10.56 per share, for net proceeds of $19.4 million. In addition, on June 16, 2020, the Company issued an additional 411,112 shares of common stock for net proceeds of $4.6 million.  

Warrants to purchase 4,434 shares of the Company’s common stock at an exercise price of $140.25 per share which were previously issued by Tocagen, survived the Merger and remained outstanding as of September 30, 2020.

On September 4, 2020, the Company entered into an “at-the-market” equity offering program (“ATM Facility”), as amended on October 28, 2020, whereby the Company may from time to time offer and sell shares of its common stock up to an aggregate offering price of $10.0 million during the term of the ATM Facility. The

12


Company is not obligated to sell any shares under the ATM Facility. The ATM Facility may be terminated at any time upon ten days’ prior notice, or at any time in certain circumstances, including the occurrence of a material adverse effect on the Company. The Company has agreed to pay the sales agent a commission equal to 3.0% of the gross proceeds from the sales of shares under the ATM Facility and has agreed to provide the sales agent with customary indemnification and contribution rights. The Company had not issued any common stock under the ATM Facility as of September 30, 2020.

 

7. Stock-Based Compensation

Equity Plans

In December 2018, Forte Subsidiary adopted the 2018 Equity Incentive Plan (the “2018 Incentive Plan”). The terms and conditions of stock-based awards were defined at the sole discretion of Forte Subsidiary’s Board of Directors. Service-based awards, vesting over a defined period of service, and performance-based awards that vest upon the achievement of defined conditions have been issued under the 2018 Incentive Plan. Service-based awards to employees generally vest over a four-year period, with the first 25% of such awards vesting following twelve months of continued employment or service with the remaining awards vesting monthly in equal installments over the following thirty-six months. Stock options granted under the 2018 Incentive Plan expire ten years from the date of grant and the exercise price must be at least equal to the fair market value of common stock on the grant date. In connection with the Merger, all outstanding options under the 2018 Incentive Plan were exchanged into options to purchase common stock of Tocagen, which changed its name to Forte Biosciences Inc. after the Merger.  Subsequent to the Merger, the 2018 Incentive Plan was frozen and no more stock-based awards will be granted.

In connection with the Merger, the Company assumed Tocagen’s 2017 Equity Incentive Plan, which was effective on April 12, 2017 and was subsequently amended September 30, 2018 and further amended February 12, 2019 (the “2017 Plan”). The 2017 Plan provides for the grant of incentive stock options (“ISOs”), nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance-based stock awards, other forms of equity compensation and performance cash awards. ISOs may be granted only to employees. All other awards may be granted to employees, including officers, and to non-employee directors and consultants of the Company and its affiliates. Subsequent to the Merger, service-based awards generally vest over a four-year period, with the first 25% of such awards vesting following twelve months of continued employment or service and the remaining awards vesting monthly in equal installments over the following thirty-six months. For certain service-based awards to the board of directors, vesting occurs in thirty-six equal monthly installments over a three-year period. As of September 30, 2020, there were 28,862 shares available for issuance under the 2017 Plan.

Immediately upon closing of the Merger, 61,406 restricted stock awards and stock options to purchase 26,968 shares of common stock granted under the 2017 Plan prior to the Merger became fully vested in consideration for pre-merger services provided to Tocagen.

On July 26, 2020, the Company adopted the 2020 Inducement Equity Incentive Plan (the “2020 Inducement Plan”) and reserved 500,000 shares for future grant under the 2020 Inducement Plan.  As of September 30, 2020, there were 265,000 shares available for issuance under the 2020 Inducement Plan.

Options

The risk-free interest rate assumption for options is based on the U.S. Treasury yield curve rate at the date of grant with a maturity approximating the expected term of the option.

The expected term assumption for options granted to employees is determined using the simplified method that represents the average of the contractual term of the option and the weighted average vesting period of the option. The Company uses the simplified method because it does not have sufficient historical option exercise data to provide a reasonable basis upon which to estimate expected term.

Due to the Company’s limited trading of its common stock and lack of company-specific historical or implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies in the life sciences industry whose shares are publicly traded. The Company selects the peer

13


group based on comparable characteristics, including development stage, product pipeline, and enterprise value. The Company will continue to apply this process until sufficient amount of historical information regarding the volatility of its own stock price become available. The historical volatility is generally calculated based on a period of time commensurate with the expected term assumption.

The assumed dividend yield is based upon the Company’s expectation of not paying dividends in the foreseeable future. Prior to the Merger, the fair value per share was determined by the Company’s Board of Directors, as of the date of each grant based on independent third-party valuations, taking into consideration various objective and subjective factors. Subsequent to the Merger, the fair value per share is the closing stock price on the option grant date.

The weighted average grant-date fair value of stock options granted to employees and non-employees in the three and nine months ended September 30, 2020 was $13.34 and $10.30, respectively. The weighted-average assumptions used to value these stock options using the Black-Scholes option-pricing were as follows.

 

 

Three months ended September 30, 2020

 

 

Nine months ended

September 30, 2020

 

Fair value of common stock and exercise price

 

$

21.64

 

 

$

16.79

 

Risk-free interest rate

 

 

0.36

%

 

 

0.49

%

Dividend yield

 

 

0.00

%

 

 

0.00

%

Expected term of options (years)

 

 

6.08

 

 

 

6.01

 

Volatility

 

 

70.0

%

 

 

70.0

%

 

          The table below summarizes the stock option activity during the nine months ended September 30, 2020:

 

 

 

Number of

Shares

Outstanding

 

 

Weighted-

Average

Exercise Price

 

 

Weighted-

Average

Remaining

Contractual

Term

(Years)

 

 

Aggregate

Intrinsic

Value (in thousands)

 

Balances at December 31, 2019

 

 

516,521

 

 

$

0.85

 

 

 

9.00

 

 

 

 

 

Granted

 

 

570,015

 

 

$

16.79

 

 

 

 

 

 

 

 

 

Assumed from reverse merger

 

 

26,968

 

 

$

9.59

 

 

 

 

 

 

 

 

 

Exercised

 

 

(74,842

)

 

$

3.44

 

 

 

 

 

 

$

249

 

Cancelled/Forfeited

 

 

(166

)

 

$

9.59

 

 

 

 

 

 

 

 

 

Balances at September 30, 2020

 

 

1,038,496

 

 

$

9.64

 

 

9.01

 

 

$

40,366

 

Vested and expected to vest at September 30, 2020

 

 

1,038,496

 

 

$

9.64

 

 

9.01

 

 

$

40,366

 

Exercisable at September 30, 2020