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, 2017March 31, 2022

ORor

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

For the transition period from                     to                     

For the transition period from

to

Commission File Number: 001-37718

 

Spring Bank Pharmaceuticals, Inc.F-STAR THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

52-2386345

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

 

86 South StreetEddeva B920 Babraham Research Campus

Hopkinton, MACambridge, United Kingdom

01748CB22 3AT

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (508) 473-5993+44-1223-497400

 

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class

Trading

Symbol

Name of each exchange
on which registered

Common Stock, $0.0001 par value per share

FSTX

The Nasdaq Stock Market

(Nasdaq Capital Market)

Indicate by check mark whether the registrantRegistrant: (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 registrantRegistrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes    No   NO

Indicate by check mark whether the registrantRegistrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 registrantRegistrant was required to submit and post such files). Yes    No   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

  (Do not check if a smaller reporting company)

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 7(a)(2)(B)13(a) of the SecuritiesExchange Act.

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

AsThe number of October 31, 2017, the registrant had 12,951,033 shares of common stock, $0.0001 par value per share, outstanding.Registrant’s Common Stock outstanding as of March 31, 2022 was 21,493,212.


Spring Bank Pharmaceuticals,F-star Therapeutics, Inc.

INDEX

INDEXPART I. FINANCIAL INFORMATION

 

 

 

Page

 

 

PART I. FINANCIAL INFORMATION

Item 1.

Condensed Consolidated Financial Statements (Unaudited)

2

 

Condensed Consolidated Balance Sheets at March 31, 2022 and December 31, 2021

32

 

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

43

 

Condensed Consolidated Statement of Stockholders’ Equity for the Three Months Ended March 31, 2022 and 2021

4

Condensed Consolidated Statements of Cash Flows for the three Months Ended March 31, 2022 and 2021

5

 

Notes to Unaudited Condensed Consolidated Financial Statements

6

Item 2.

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

2022

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

3336

Item 4.

Controls and Procedures

3336

 

PART II. OTHER INFORMATION

 

Item 1.

Legal Proceedings

34

Item 1A.1.

Risk FactorsLegal Proceedings

3437

Item 5.1A.

Other InformationRisk Factors

3437

Item 6.2

ExhibitsUnregistered Sales of Equity Securities and Use of Proceeds

3437

Item 3

Defaults Upon Senior Securities

37

Item 4

Mine Safety Disclosures

37

Item 5

Other Information

37

Item 6.

Exhibits

37

Exhibit Index

3538

Signatures

3639

i


FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “design,” “expect,” “seek,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions.

These forward-looking statements include, but are not limited to, statements about:

our ongoing and planned preclinical studies and clinical trials;

preclinical study data and clinical trial data and the timing of results of our ongoing clinical studies and/or trials;

the timing of and our ability to obtain and maintain regulatory approvals for our product candidates;

our plans to seek and enter into clinical trial collaborations and other broader collaborations;

our commercialization, marketing and manufacturing capabilities and strategy; and

our estimates regarding prospects, strategies, expenses, operating capital requirements, results of operations and needs for additional financing.

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. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Factors that could cause actual results or events to differ materially from the forward-looking statements that we make include, but are not limited to, the following:

Our business currently depends substantially on the success of clinical trials for inarigivir soproxil (formerly known as SB 9200), which we refer to as inarigivir, which is still under development. If we are unable to obtain regulatory approval for, or successfully commercialize, inarigivir, our business will be materially harmed.

We are very early in our development efforts and our product candidates may not be successful in later stage clinical trials.  Results obtained in our preclinical studies and clinical trials are not necessarily indicative of results to be obtained in future clinical trials.  As a result, our product candidates may never be approved as marketable therapeutics.

We will need additional funding to complete the development of our product candidates and before we can expect to become profitable from the sales of our products, if approved. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.

We rely, and expect to continue to rely, on third parties to conduct our clinical trials and to manufacture our product candidates for preclinical and clinical testing. These third parties may not perform satisfactorily, which could delay our product development activities.

If we are unable to adequately protect our proprietary technology, or obtain and maintain issued patents which are sufficient to protect our product candidates, others could compete against us more directly, which would have a material adverse impact on our business, results of operations, financial condition and prospects.

We may not be able to retain key executives or to attract, retain and motivate key personnel.  If we are unable to retain such key personnel, it could have a material adverse impact on our business and prospects.

You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. You should also read carefully the factors described in the section “Risk Factors” of this Quarterly Report on Form 10-Q and “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2016 to better understand the risks and uncertainties inherent in our business and underlying any forward-looking statements. You are advised, however, to consult any further disclosures we make on related subjects in our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, press releases, and our website. Any forward-looking statements that we make in this Quarterly Report on Form 10-Q speak only as of the date of this Quarterly Report on Form 10-Q, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q or to reflect the occurrence of unanticipated events.


PART I—FINANCIALFINANCIAL INFORMATION

Item 1.

Financial Statements.

SPRING BANK PHARMACEUTICALS, INC.Item 1. Financial Statements.

CONSOLIDATED BALANCE SHEETSF-star Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(In Thousands, Except Share and Per Share Data)Amounts)

 

 

September 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

ASSETS

 

(unaudited)

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

     Cash and cash equivalents

 

$

17,539

 

 

$

10,684

 

     Marketable securities

 

 

34,640

 

 

 

14,046

 

     Prepaid expenses and other current assets

 

 

850

 

 

 

840

 

Total current assets

 

 

53,029

 

 

 

25,570

 

     Marketable securities, long-term

 

 

 

 

 

752

 

     Property and equipment, net

 

 

534

 

 

 

522

 

     Restricted cash

 

 

250

 

 

 

 

     Other assets

 

 

35

 

 

 

35

 

Total

 

$

53,848

 

 

$

26,879

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

     Accounts payable

 

$

1,773

 

 

$

1,519

 

     Accrued expenses and other current liabilities

 

 

2,312

 

 

 

1,982

 

Total current liabilities

 

 

4,085

 

 

 

3,501

 

     Warrant liabilities

 

 

17,807

 

 

 

6,333

 

     Other long-term liabilities

 

 

32

 

 

 

27

 

Total liabilities

 

 

21,924

 

 

 

9,861

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value—authorized, 10,000,000 shares at September 30,

     2017 and December 31, 2016; no shares issued or outstanding at September 30, 2017

     and December 31, 2016

 

 

 

 

 

 

Common stock, $0.0001 par value—authorized, 200,000,000 shares at September 30,

     2017 and December 31, 2016; 12,697,038 and 9,416,238 shares issued and outstanding

     at September 30, 2017 and December 31, 2016, respectively

 

 

1

 

 

 

1

 

Additional paid-in capital

 

 

109,682

 

 

 

68,559

 

Accumulated deficit

 

 

(77,752

)

 

 

(51,535

)

Other comprehensive loss

 

 

(7

)

 

 

(7

)

Total stockholders’ equity

 

 

31,924

 

 

 

17,018

 

Total

 

$

53,848

 

 

$

26,879

 

 

 

March 31,

 

 

December 31,

 

 

 

2022

 

 

2021

 

 

 

Unaudited

 

 

Audited

 

Assets

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

68,801

 

 

$

78,549

 

Other receivables

 

 

15

 

 

 

 

Prepaid expenses and other current assets

 

 

4,318

 

 

 

3,879

 

Tax incentive receivable

 

 

4,152

 

 

 

2,311

 

Total current assets

 

 

77,286

 

 

 

84,739

 

Property and equipment, net

 

 

743

 

 

 

887

 

Right of use asset

 

 

3,034

 

 

 

3,281

 

Goodwill

 

 

14,772

 

 

 

14,898

 

In-process research and development and intangible assets, net

 

 

18,427

 

 

 

18,765

 

Other long-term assets

 

 

444

 

 

 

451

 

Total assets

 

$

114,706

 

 

$

123,021

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

Accounts payable

 

$

4,310

 

 

$

3,081

 

Accrued expenses and other current liabilities

 

 

5,511

 

 

 

6,241

 

Contingent value rights

 

 

1,936

 

 

 

1,907

 

Lease obligations, current

 

 

896

 

 

 

906

 

Total current liabilities

 

 

12,653

 

 

 

12,135

 

Long term Liabilities:

 

 

 

 

 

 

Term debt

 

 

9,675

 

 

 

9,605

 

Lease obligations

 

 

2,484

 

 

 

2,723

 

Contingent value rights

 

 

1,723

 

 

 

1,694

 

Deferred tax liability

 

 

7

 

 

 

7

 

Total liabilities

 

 

26,542

 

 

 

26,164

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; authorized, 10,000,000 shares at December
   31, 2021 and 2020;
0 shares issued or outstanding at March 31, 2022
   December 31, 2021

 

 

 

 

 

 

Common Stock, $0.0001 par value; authorized 200,000,000 shares at
   March 31, 2022 and December 31, 2021;
21,493,212 and 20,874,590
   shares issued and outstanding at March 31, 2022 and December 31, 2021

 

 

2

 

 

 

2

 

Additional paid-in capital

 

 

180,141

 

 

 

176,808

 

Accumulated other comprehensive loss

 

 

(1,441

)

 

 

(1,502

)

Accumulated deficit

 

 

(90,538

)

 

 

(78,451

)

Total stockholders’ equity

 

 

88,164

 

 

 

96,857

 

Total liabilities and stockholders’ equity

 

$

114,706

 

 

$

123,021

 

See accompanying notes to consolidated financial statements.

 

2



SPRING BANK PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSSF-star Therapeutics, Inc.

(Unaudited)Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(In Thousands, Except Share and Per Share Data)Amounts)

 

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Grant revenue

 

$

 

 

$

 

 

$

 

 

$

352

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

3,221

 

 

 

2,723

 

 

 

9,152

 

 

 

11,247

 

General and administrative

 

 

1,968

 

 

 

1,452

 

 

 

5,811

 

 

 

4,136

 

Total operating expenses

 

 

5,189

 

 

 

4,175

 

 

 

14,963

 

 

 

15,383

 

Loss from operations

 

 

(5,189

)

 

 

(4,175

)

 

 

(14,963

)

 

 

(15,031

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

141

 

 

 

27

 

 

 

220

 

 

 

65

 

Change in fair value of warrant liabilities

 

 

(5,780

)

 

 

 

 

 

(11,474

)

 

 

 

Net loss

 

 

(10,828

)

 

 

(4,148

)

 

 

(26,217

)

 

 

(14,966

)

Unrealized (loss) gain on marketable securities

 

 

(10

)

 

 

(3

)

 

 

(7

)

 

 

18

 

Comprehensive loss

 

$

(10,838

)

 

$

(4,151

)

 

$

(26,224

)

 

$

(14,948

)

Net loss per common share – basic and diluted

 

$

(0.85

)

 

$

(0.53

)

 

$

(2.48

)

 

$

(2.18

)

Weighted-average number of shares outstanding – basic and diluted

 

 

12,696,986

 

 

 

7,759,630

 

 

 

10,555,461

 

 

 

6,856,876

 

 

 

For the Three Months
Ended March 31,

 

 

 

2022

 

 

 

 

2021

 

License revenue

 

$

2,551

 

 

 

 

$

2,917

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

 

8,037

 

 

 

 

 

7,132

 

General and administrative

 

 

5,702

 

 

 

 

 

6,429

 

Total operating expenses

 

 

13,739

 

 

 

 

 

13,561

 

Loss from operations

 

 

(11,188

)

 

 

 

 

(10,644

)

Other non-operating (expense) income:

 

 

 

 

 

 

 

 

Interest expense

 

 

(308

)

 

 

 

 

(87

)

Change in fair value of contingent value rights

 

 

(58

)

 

 

 

 

 

Other (expense) income

 

 

(533

)

 

 

 

 

1,105

 

Total other non-operating (expense) income

 

 

(899

)

 

 

 

 

1,018

 

Net loss before income taxes

 

 

(12,087

)

 

 

 

 

(9,626

)

Income tax expense

 

 

 

 

 

 

 

(108

)

Net loss

 

$

(12,087

)

 

 

 

$

(9,734

)

Basic and diluted adjusted net loss per common
   shares

 

$

(0.57

)

 

 

 

$

(1.07

)

Weighted-average number of shares
   outstanding, basic and diluted

 

 

21,083,473

 

 

 

 

 

9,100,273

 

Other comprehensive loss:

 

 

 

 

 

 

 

 

Net loss

 

$

(12,087

)

 

 

 

$

(9,734

)

Other comprehensive (loss) gain :

 

 

 

 

 

 

 

 

Foreign currency translation

 

 

61

 

 

 

 

 

(468

)

Total comprehensive loss

 

$

(12,026

)

 

 

 

$

(10,202

)

See accompanying notes to consolidated financial statements.

 

3



SPRING BANK PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWSF-star Therapeutics, Inc.

(Unaudited)Condensed Consolidated Statements of Stockholders’ Equity

For the three months ended March 31, 2022 and 2021

(Unaudited)

(In Thousands)Thousands, Except Share Amounts)

 

 

 

For the Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(26,217

)

 

$

(14,966

)

Adjustments for:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

115

 

 

 

87

 

Change in fair value of warrant liabilities

 

 

11,474

 

 

 

 

Non-cash investment income (losses)

 

 

(50

)

 

 

28

 

Non-cash stock-based compensation

 

 

1,483

 

 

 

1,015

 

Non-cash issuance of common stock and warrants connected to license agreement

 

 

 

 

 

2,780

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

(10

)

 

 

(746

)

Other assets

 

 

 

 

 

(35

)

Accounts payable

 

 

254

 

 

 

148

 

Accrued expenses and other liabilities

 

 

311

 

 

 

(19

)

Net cash used in operating activities

 

 

(12,640

)

 

 

(11,708

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchases of marketable securities

 

 

(34,397

)

 

 

(6,693

)

Proceeds from sale of marketable securities

 

 

14,605

 

 

 

4,894

 

Purchases of property and equipment

 

 

(127

)

 

 

(156

)

Net cash used in investing activities

 

 

(19,919

)

 

 

(1,955

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock

 

 

42,500

 

 

 

11,339

 

Payment of finance costs related to issuance of common stock

 

 

(2,928

)

 

 

(2,128

)

Proceeds from exercise of warrants

 

 

 

 

 

5,342

 

Proceeds from exercise of stock options

 

 

92

 

 

 

95

 

Cash provided by financing activities

 

 

39,664

 

 

 

14,648

 

Net increase in cash, cash equivalents and restricted cash

 

 

7,105

 

 

 

985

 

Cash and cash equivalents, beginning of period

 

 

10,684

 

 

 

4,347

 

Cash, cash equivalents and restricted cash, end of period

 

$

17,789

 

 

$

5,332

 

Supplemental disclosures of cash flow information:

 

 

 

 

 

 

 

 

Cash paid for taxes

 

$

1

 

 

$

1

 

Cash paid for interest

 

$

 

 

$

 

Supplemental disclosures of noncash financing activities:

 

 

 

 

 

 

 

 

Issuance of common stock warrants in connection with initial public offering

 

$

 

 

$

218

 

 

 

Stockholders’ Equity

 

 

 

Common Shares

 

 

 

 

 

 

 

 

 

 

 

 

 

For the Three Months Ended March 31, 2022

 

Number of
Shares

 

 

Value

 

 

Capital in Excess
of par Value

 

 

Accumulated Other
Comprehensive
Loss

 

 

Accumulated
deficit

 

 

Total Stockholders’
Equity

 

Balance at December 31, 2021

 

 

20,874,590

 

 

 

2

 

 

 

176,808

 

 

 

(1,502

)

 

 

(78,451

)

 

 

96,857

 

Issuance of common stock in connection with at-the-
  market offering, net of issuance costs

 

 

545,054

 

 

 

 

 

 

1,949

 

 

 

 

 

 

 

 

 

1,949

 

RSU vesting, net of shares repurchased to cover tax
  withholding

 

 

73,568

 

 

 

 

 

 

(70

)

 

 

0

 

 

 

 

 

 

(70

)

Share-based compensation

 

 

 

 

 

 

 

 

1,454

 

 

 

 

 

 

 

 

 

1,454

 

Equity adjustment from foreign currency translation

 

 

 

 

 

 

 

 

 

 

 

61

 

 

 

 

 

 

61

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(12,087

)

 

 

(12,087

)

Balance at March 31, 2022

 

 

21,493,212

 

 

$

2

 

 

$

180,141

 

 

$

(1,441

)

 

$

(90,538

)

 

$

88,164

 

 

 

Stockholders’ Equity

 

 

 

Common Shares

 

 

 

 

 

 

 

 

 

 

 

 

 

For the Three Months Ended March 31, 2021

 

Number of
shares

 

 

Value

 

 

Capital in Excess
of par Value

 

 

Accumulated Other
Comprehensive Loss

 

 

Accumulated
deficit

 

 

Total Stockholders’
Equity

 

Balance at December 31, 2020

 

 

9,100,117

 

 

$

1

 

 

$

91,238

 

 

$

(1,077

)

 

$

(47,168

)

 

$

42,994

 

Equity adjustment from foreign
   currency translation

 

 

 

 

 

 

 

 

 

 

 

(468

)

 

 

 

 

 

(468

)

Stock option exercises

 

 

203

 

 

 

 

 

 

 

 

 

0

 

 

 

 

 

 

0

 

Share-based compensation

 

 

 

 

 

 

 

 

2,180

 

 

 

 

 

 

 

 

 

2,180

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,734

)

 

 

(9,734

)

Balance at March 31, 2021

 

 

9,100,320

 

 

$

1

 

 

$

93,418

 

 

$

(1,545

)

 

$

(56,902

)

 

$

34,972

 

See accompanying notes to consolidated financial statements.

4



Spring Bank Pharmaceuticals,F-star Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows (Unaudited)

(In Thousands)

 

 

For the Three Months Ended March 31,

 

 

 

2022

 

 

2021

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(12,087

)

 

$

(9,734

)

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

 

 

 

 

 

 

Share based compensation expense

 

 

1,454

 

 

 

2,180

 

Foreign currency (gain) loss

 

 

614

 

 

 

(670

)

(Gain) loss on disposal of property, plant and equipment

 

 

 

 

 

(9

)

Depreciation

 

 

122

 

 

 

144

 

Amortization of intangible assets

 

 

65

 

 

 

 

      Non-cash interest

 

 

29

 

 

 

 

Amortization of debt issuance costs

 

 

42

 

 

 

77

 

Fair value adjustments

 

 

58

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Other receivables

 

 

(15

)

 

 

(2,805

)

Prepaid expenses and other current assets

 

 

(534

)

 

 

566

 

Tax incentive receivable

 

 

(1,952

)

 

 

(413

)

Operating right of use asset

 

 

223

 

 

 

278

 

Accounts payable

 

 

1,197

 

 

 

(548

)

Accrued expenses and other current liabilities

 

 

(606

)

 

 

(2,473

)

Deferred revenue

 

 

 

 

 

(304

)

Operating lease liability

 

 

(225

)

 

 

(272

)

Other long term asset

 

 

 

 

 

(395

)

Net cash used in operating activities

 

 

(11,615

)

 

 

(14,378

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchase of property, plant and equipment

 

 

 

 

 

(267

)

Proceeds from sale of property, plant and equipment

 

 

 

 

 

15

 

Net cash used in investing activities

 

 

 

 

 

(252

)

Cash flows from financing activities:

 

 

 

 

 

 

Net proceeds from issuance of common stock, net

 

 

1,949

 

 

 

 

Payments to tax authorities in connection with shares directly withheld from
  employees

 

 

(70

)

 

 

 

Net cash provided by financing activities

 

 

1,879

 

 

 

 

Net increase in cash and cash equivalents

 

 

(9,736

)

 

 

(14,630

)

Effect of exchange rate changes on cash

 

 

(12

)

 

 

(216

)

Cash and cash equivalents at beginning of period

 

 

78,549

 

 

 

18,526

 

Cash and cash equivalents at end of period

 

$

68,801

 

 

$

3,680

 

Supplemental disclosure of cash flow information

 

 

 

 

 

 

Interest paid

 

$

238

 

 

$

0

 

Purchases of intangible assets included in accounts payable and accrued expenses

 

$

100

 

 

$

 

Purchases of property and equipment included in accounts payable and accrued
  expenses

 

$

 

 

$

97

 

 

 

 

 

 

 

 

Non-cash investing and financing activities:

 

 

 

 

 

 

Additions to ROU assets obtained from new operating lease liabilities

 

 

 

 

 

1,468

 

See accompanying notes to consolidated financial statements.

5


F-star Therapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

 

1. NATURE OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Nature of Business and Summary of Significant Accounting Policies

Spring Bank Pharmaceuticals,Nature of Business

F-star Therapeutics Inc. (the(“we” or the “Company”) is a clinical-stage biopharmaceutical company engageddedicated to developing next generation immunotherapies to transform the lives of patients with cancer. We are pioneering the use of tetravalent (2+2) bispecific antibodies to create a paradigm shift in cancer therapy. We have four second generation immuno-oncology (also referred to as "IO") therapeutics in the clinic, each directed against some of the most promising IO targets in drug development, including LAG-3 and CD137. Our proprietary antibody discovery platform is protected by an extensive intellectual property estate. We have attracted multiple partnerships with biotechnology and development of a novel class of therapeutics using apharmaceutical companies targeting significant unmet needs across several disease areas, including oncology, immunology, and indications affecting the central nervous system (“CNS”) with over 20 programs, based on our technology, being developed by our partners. Our goal is to offer patients better and more durable benefits than currently available immuno-oncology treatments by developing medicines that seek to block tumor immune evasion. Through our proprietary small molecule nucleic acid hybrid (“SMNH”tetravalent, bispecific natural antibody (mAb²™) chemistry platform. The Companyformat, our mission is developing its most advanced SMNH product candidate, inarigivir soproxil (“inarigivir”) (formerlyto generate highly differentiated medicines with monoclonal antibody-like manufacturability, good safety and tolerability.

Share Exchange Agreement

On November 20, 2020, F-star Therapeutics, Inc., formerly known as SB 9200)Spring Bank Pharmaceuticals, Inc., completed a business combination (the “Transaction”) with F-star Therapeutics Limited (“F-star Ltd”) in accordance with the terms of the Share Exchange Agreement, dated July 29, 2020 (the “Exchange Agreement”), by and among the Company, F-star Ltd and certain holders of capital stock and convertible notes of F-star Ltd (each a “Seller”, and collectively with holders of F-star Ltd securities who subsequently became parties to the Exchange Agreement, the “Sellers”). Pursuant to the Exchange Agreement, each ordinary share of F-star Ltd outstanding immediately prior to the closing of the Transaction (the “Closing”) was exchanged by the Sellers that owned such F-star Ltd shares for a number of duly authorized, validly issued, fully paid and non-assessable shares of Company common stock pursuant to the treatmentexchange ratio formula set forth in the Exchange Agreement (the “Exchange Ratio”), rounded to the nearest whole share of viral diseases. Since inceptionCompany common stock (after aggregating all fractional shares of Company common stock issuable to such Seller). Also, on November 20, 2020, in 2002connection with, and prior to completion of, the Transaction, Spring Bank effected a 1-for-4 reverse stock split of its initial public offering (“IPO”common stock (the “Reverse Stock Split”) in May 2016,and, following the completion of the Transaction, changed its name to F-star Therapeutics, Inc. Following the completion of the Transaction, the business of the Company builtbecame the business conducted by F-star, which is a clinical-stage immuno-oncology company focused on cancer treatment through its technology platformproprietary tetravalent bispecific antibody programs. Unless otherwise noted, all references to share amounts in this report reflect the Reverse Stock Split.

Liquidity

From our inception through March 31, 2022, we have not generated any revenue from product sales, and product candidate pipeline using a semi-virtual business model, supported by grantswe have incurred significant operating losses and direct fundingnegative cash flows from the United States National Institutesour operations. We do not expect to generate significant revenue from sales of Health (“NIH”) as well as through private financings. In September 2015, the Company formed a wholly owned subsidiary, Sperovie Biosciences, Inc.any products for several years, if at all.

As of March 31, 2022, we had working capital (current assets less current liabilities) of $64.6 million, an accumulated deficit of $90.5 million, cash of $68.8 million and in December 2016, the Company formed a wholly owned subsidiary, SBP Securities Corporation.

The Company’saccounts payable and accrued expenses of $9.8 million. Our future success is dependent upon itson our ability to successfully complete clinical development andobtain additional working capital, obtain regulatory approval of itsfor and successfully launch and commercialize our product candidates successfully commercialize approved products, generate revenue, and to ultimately attain profitable operations. The Company’s operations to date have been limited to financing and staffing

On March 30, 2021, the Company entered into a Sales Agreement (the “Sales Agreement”) with SVB Securities LLC with respect to an "at-the-market” (“ATM”) offering program under which the Company could offer and sell,

6


from time to time at its sole discretion, shares of its common stock, having an aggregate offering price of up to $50.0 million, through SVB Securities LLC as its sales agent. On May 6, 2021, the Company terminated the Sales Agreement.

On August 13, 2021, the Company entered into a new Sales Agreement (the “2021 Sales Agreement”) with SVB Securities LLC with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $50.0 million, through SVB Securities LLC as its sales agent.

During the quarter ended March 31, 2022, the Company had sold 545,054 shares of common stock pursuant to the 2021 Sales Agreement for gross proceeds of $2.2 million, resulting in net proceeds of $2.1 million after deducting sales commissions.

Historically, we have financed our operations primarily with proceeds from the sale and issuance of common and convertible preferred shares, proceeds from issuances in connection with a convertible note facility, proceeds received from upfront payments and development milestone payments in connection with our collaboration arrangements, payments received for research and development services and term debt. We expect to continue to use these means of inarigivir, SB 11285financing our operations until we are able to obtain regulatory approval for and the Company’s othersuccessfully commercialize one or more of our drug candidates. We cannot provide any assurance that we will obtain regulatory approval or successfully commercialize any of our current or planned future drug product candidates.

Basis of Presentation and Liquidity

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United States (“U.S.”) generally accepted accounting principles (“U.S. GAAP”).

Prior to and in connection with the Company completing its IPO in May 2016, the Company effected a 1-for-4 reverse stock split of its common stock on March 8, 2016. All share and per share amounts and the numberrules and regulations of shares of common stock set forththe U.S. Securities and Exchange Commission (the “SEC”) for interim financial statements. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the financial statementsAccounting Standards Codification (“ASC”) and notes thereto have been retroactively adjusted for all periods presented to give effect toAccounting Standards Updates (“ASU”) of the reverse stock split, including reclassifying an amount equal to the reduction in par value of common stock to additional paid-in capital.Financial Accounting Standards Board (“FASB”).

The accompanying interim condensed consolidated financial statements as of September 30, 2017March 31, 2022, and for the ninethree months ended September 30, 2017March 31, 2022 and 2016,2021, and related interim information contained within the notes to thethese condensed consolidated financial statements, are unaudited. In management’s opinion, theThese unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s audited annual consolidated financial statements and includein management's opinion contain all adjustments (including normal recurring adjustments) necessary for the fair presentation of the Company’s financial position as of September 30, 2017,March 31, 2022, results of operations for the ninethree months ended September 30, 2017March 31, 2022 and 2016,2021, statement of stockholders’ equity for the three months ended March 31, 2022 and 2021 and its cash flows for the ninethree months ended September 30, 2017March 31, 2022 and 2016.2021. These interim condensed consolidated financial statements should be read in conjunction with the Company’s annual audited consolidated financial statements and accompanying notes containedthereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the Securities and Exchange Commission (“SEC”) on February 14, 2017.2021. The results for the three and nine months ended September 30, 2017March 31, 2022, are not necessarily indicative of the results expected for the full fiscal year or any interim period.

As of September 30, 2017, the Company had an accumulated deficit of $77.8 million and $52.2 million in cash, cash equivalents and marketable securities.

The Company expects to continue to incur significant and increasing losses for the foreseeable future. The Company anticipates that its expenses will increase significantly as it continues to develop inarigivir, SB 11285 and its other product candidates.  The Company does not have any committed external source of funds. As a result, the Company will need additional financing to support its continuing operations.  Adequate additional funds may not be available to the Company on acceptable terms, or at all. To the extent that the Company raises additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect common stockholder rights. If the Company raises additional funds through collaborations, strategic alliances or licensing arrangements with third parties, the Company may have to relinquish valuable rights to its technologies, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to the Company.



Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts of the CompanyF-star Therapeutics, Inc. and its wholly owned subsidiaries, Sperovie Biosciences, Inc. and SBP Securities Corporation. Sperovie Biosciences, Inc. had operations consisting mainly of legal fees associated with intellectual property activities as of September 30, 2017. SBP Securities Corporation had assets primarily related to investments in marketable securities and operations consisting primarily of interest income as of September 30, 2017.subsidiaries. All intercompanyinter-company balances and transactions between the consolidated companies have been eliminated in consolidation.

Use of Estimates

The preparation of the condensed 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, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period.years. Significant estimates and assumptions reflected in these

7


condensed consolidated financial statements include, but are not limited to, the fair value of the assets and liabilities acquired in the transaction between Spring Bank and F-star Ltd, the fair value of contingent value rights, the accrual for research and development expenses, revenue recognition, fair values of acquired intangible assets and impairment review of those assets, share based compensation expense, and income taxes. The Company bases its estimates and assumptions on historical experience, when availableknown trends and on variousother market-specific or other relevant factors that it believes to be reasonable under the circumstances. SignificantEstimates are periodically reviewed in light of reasonable changes in circumstances, facts and experience. Changes in estimates relied uponare recorded in preparing the accompanying financial statements related to the fair value of common stock and warrant liabilities, accounting for stock-based compensation, income taxes, useful lives of long-lived assets, and accounting for certain accruals. The Company evaluates its estimates and assumptions on an ongoing basis. The Company’s actualperiod in which they become known. Actual results maycould differ from these estimates.those estimates or assumptions.

Concentrations of credit risk and of significant suppliers

Cash, Cash Equivalents and Restricted Cash

Cash equivalents are stated at fair value and include short-term, highly liquid investments with remaining maturities of 90 days or less at the date of purchase.

Restricted cash consists of $250,000 and is held as collateral for the Company’s credit card program. There were no restricted cash as of December 31, 2016.

Included in cash and cash equivalents as of September 30, 2017 and December 31, 2016 are money market fund investments of $15,164,000 and $9,507,000, respectively, which are reported at fair value (Note 5).           

Concentration of Credit Risk

Financial instruments that subjectpotentially expose the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains its cash and cash equivalents restricted cash and marketable securities. Substantially all of the Company’s cash is held atin financial institutions in amounts that management believes to be of high-credit quality. Deposits with these financial institutions maycould exceed the amount of insurance provided on such deposits; however, these deposits may be redeemed upon demand and, therefore, bear minimal risk.

The Company’s one source of revenue during the three and nine months ended September 30, 2016 was grants from the NIH, representing 100% of total revenue for such periods.government-insured limits. The Company diddoes not have any sources of revenue for the three and nine months ended September 30, 2017.believe it is subject to additional credit risks beyond those normally associated with commercial banking relationships.

Investments in Marketable Securities

The Company invests excess cash balancesis dependent on contract research organizations to provide its clinical trials and third-party manufacturers to supply products for research and development activities in short-term and long-term marketable securities. The Company classifies investments in marketable securities as either held-to-maturity or available-for-sale based on facts and circumstances present at the time of purchase. At each balance sheet date presented, all investments in securities are classified as available-for-sale. The Company reports available-for-sale investments at fair value at each balance sheet date and includes 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 other income (expense). If any adjustment to fair value reflects a decline in the value of the investment,its programs. In particular, the Company considers all available evidencerelies and expects to evaluatecontinue to rely on a small number of manufacturers to supply its requirements for supplies and raw materials related to these programs. These programs could be adversely affected by a significant interruption in these manufacturing services or the extent to which the decline is “other than temporary,” including the intention to sellavailability of raw materials.

Property, plant and if so, marks the investment to market through a charge to the Company’s consolidated statements of operations and comprehensive loss.equipment



Property, and Equipment, Net

Propertyplant and equipment are recordedstated at cost. Costs associated with maintenance and repairs are expensed as incurred. cost, less accumulated depreciation. Depreciation and amortization are providedexpense is recognized using the straight-line method over the estimated useful lives:lives of the respective assets as follows:

Asset Category

Estimated Useful Economic Life

EquipmentLeasehold property improvements, right of use assets

5-7 yearsLesser of lease term or useful life

Furniture and fixturesLaboratory equipment

5 years

Leasehold improvementsFurniture and office equipment

Lesser of 103 years or the remaining

term of the respective lease

Leases

The Company determines if an arrangement is a lease at inception. Operating leases are included in right-of-use (“ROU”) assets, and lease obligations in the Company’s consolidated balance sheets.

ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The operating lease ROU asset also includes any lease payments made and excludes lease incentives. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term.

Impairment of Long-Lived Assetslong-lived assets

Long-lived assets to be held and used are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. When such events occur, the Company compares the carrying amounts of the assets to their undiscounted expected future cash flows. If the undiscounted cash flows are insufficient to recover the carrying value, an impairment loss is recorded for the difference between the carrying value and fair value of the asset. Through September 30, 2017, noAs of March 31, 2022, 0 such impairment has occurred.been recorded.

8


License and collaboration arrangements and revenue recognition

Deferred Rent

The Company’s operating leasesrevenues are generated primarily through license and collaboration agreements with pharmaceutical and biotechnology companies. The terms of these arrangements may include rent escalation payment terms and other incentives received from landlords. Deferred rent represents(i) the difference between actual operating lease payments due and straight-line rent expense overgrant of intellectual property rights (IP licenses) to therapeutic drug candidates against specified targets, developed using the term of the lease, which is recorded in accrued expenses and other current liabilities. The Company had deferred aggregate rent for itsCompany’s proprietary mAb2 bispecific antibody platform, (ii) performing research and development facility in Milford, Massachusettsservices to optimize drug candidates, and its headquarters in Hopkinton, Massachusetts(iii) the grant of $35,000options to obtain additional research and $35,000 asdevelopment services or licenses for additional targets, or to optimize product candidates, upon the payment of September 30, 2017option fees.

The terms of these arrangements typically include payment to the Company of one or more of the following:

non-refundable, upfront license fees; payments for research and December 31, 2016, respectively.development services; fees upon the exercise of options to obtain additional services or licenses; payments based upon the achievement of defined collaboration objectives; future regulatory and sales-based milestone payments; and royalties on net sales of future products.

Revenue Recognition

The Company recognizes revenue whenhas adopted FASB ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. To date, the following criteria are met: there is persuasive evidenceCompany has entered into License and Collaboration Agreements with Denali Therapeutics, Inc. (“Denali”), Ares Trading S.A. (“Ares”), an affiliate of an arrangement,Merck KGaA, Darmstadt, Germany, AstraZeneca AB ("AstraZeneca") and Janssen Biotech, Inc. ("Janssen") which were determined to be within the fee is fixed or determinable, delivery has occurred or services have been rendered and collectionscope of the related receivable is reasonably assured. Generally, these criteria were met and revenue from grants from the NIH, which subsidized certain of the Company’s research projects, as efforts were expended and as eligible project costs were incurred.ASC 606.

Research and Development Costsdevelopment costs

Research and development costs are expensed as incurred. Research and development expenses consist primarilyare comprised of costs incurred in performing clinical trials, research and development activities, including compensation expense, share-based compensation and benefits, facilities costs and laboratory supplies, depreciation, amortization and impairment expense, manufacturing expenses and external costs of outside vendors engaged to conduct preclinical development activities as well as the cost of licensing technology. Typically, upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred, except for payments relating to intellectual property rights with future alternative use which will be expensed when the intellectual property is in use. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.

Warrants

The Company accounts for warrants within stockholders equity or as liabilities based on the characteristics and provisions of each instrument. The Company evaluates outstanding warrants in accordance with ASC 480, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging. If none of the criteria in the evaluation in these standards are met, the warrants are classified as a component of stockholders’ equity and initially recorded at their grant date fair value without subsequent remeasurement. Warrants that meet the criteria are classified as liabilities and remeasured to their fair value at the end of each reporting period.

Stock-Based Compensation

The Company accounts for share-based compensation in accordance with ASC 718, “Compensation – Stock Compensation”(“ASC 718”). ASC 718 requires companies to estimate the fair value of equity-based payment awards on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as an expense over the requisite service period in the Company’s research activities, including discovery efforts,consolidated statements of operations and comprehensive loss.

Fair value measurements of financial instruments

The Company’s financial instruments consist of cash, accounts payable, Contingent Value Rights (“CVRs”) and liability classified warrants. The carrying amounts of cash and accounts payable approximate their fair value due to

9


the short-term nature of those financial instruments. The fair value of CVRs and the liability classified warrants are remeasured to fair value each reporting period.

Net loss per share

The Company computes net loss per share in accordance with ASC Topic 260, Earnings Per Share (“ASC 260”) and related guidance, which requires two calculations of net (loss) income attributable to the Company’s shareholders per share to be disclosed: basic and diluted. Convertible preferred shares are considered participating securities and are included in the calculation of basic and diluted net (loss) income per share using the two-class method. In periods where the Company reports net losses, such losses are not allocated to the convertible preferred shares for the computation of basic or diluted net (loss) income.

Diluted net (loss) income per share is the same as basic net (loss) income per share for the periods in which the Company had a net loss because the inclusion of outstanding common stock equivalents would be anti-dilutive.

Income taxes

The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. The potential recovery of deferred tax assets is evaluated by estimating the potential for future taxable profits, if any.

Research and development of product candidates, which include:tax credit

As the entity located in the United Kingdom (“UK”) carries out extensive research and development, and clinical trial activities, it seeks to benefit from the UK research and development tax credit cash rebate regime known as the Small and Medium-sized Enterprises R&D Tax Credit Program (the “SME Program”). Qualifying expenditures largely comprise employment costs for research staff, consumables expenses incurred under agreements with third parties including contract research organizations, or CROs, that conduct research and development, preclinical activities, clinical activities and manufacturing on the Company’s behalf and certain internal overhead costs incurred as part of research projects. The tax credit received in the UK pursuant to the SME Program permits companies to deduct an extra 130% of their qualifying costs from their yearly profit or loss, as well as the normal 100% deduction, to make a total 230% deduction. If the company is incurring losses, it is entitled to claim a tax credit worth up to 14.5% of the surrenderable loss. To qualify for relief under the SME Program, companies are required to employ fewer than 500 staff and have a turnover of under €100.0 million or a balance sheet total of less than €86.0 million.

Research and development tax credits received in the UK are recorded as a reduction in research and development expenses. The UK research and development tax credit is payable to companies after surrendering tax losses and is not dependent on current or future taxable income. As a result, it is not reflected as part of the income tax provision.

Contingencies

Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential loss range is probable and reasonably estimable under the provisions of the authoritative guidelines that address accounting for contingencies. The Company expenses costs as incurred in relation to such legal proceedings as general and administrative expense within the consolidated statements of operations and comprehensive loss.

10


Recently Issued Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on its consolidated financial statements and disclosures.

Going Concern

The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates realization of assets and the satisfaction of liabilities and commitments in the normal course of business. Since inception, the Company has devoted substantially all of its efforts to business planning, research and development, pre-clinical and clinical activities, recruiting management and technical staff, and securing funding via collaborations. The Company has historically funded its operations with proceeds from its collaboration arrangements, sale and issuance of its common stock and preferred stock, and proceeds from the sale and issuance of convertible notes and debt financing. As of March 31, 2022, the Company had incurred significant losses and has an accumulated deficit of $90.5 million. The Company had approximately $68.8 million in cash and cash equivalents as of March 31, 2022. The Company expects to continue to generate operating losses in the foreseeable future, particularly as the Company advances its pre-clinical activities and clinical trials for its product candidates in development. The Company plans to seek additional funding through public equity, private equity, debt financing, collaboration partnerships, or other sources. There are no assurances, however, that the Company will be successful in these endeavors.

If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate its research and development programs, or reduce product candidate expansion, which could adversely affect its business prospects. Although management continues to pursue its funding plans, there is no assurance that the Company will be successful in obtaining sufficient funding to continue operations on terms acceptable to the Company, if at all. Management believes that its existing cash and cash equivalents at March 31, 2022 will fund our current operating plan into the first quarter of 2023. Accordingly, the Company has concluded that substantial doubt exists concerning the Company’s ability to continue as a going concern for a period of at least twelve months from the date of the financial statements.

2. Net Loss Per Share

The following table presents the calculation of basic and diluted net loss per share applicable to common stockholders of the Company (in thousands, except share and per share data):

Net Loss Per Share

 

 

 

For the Three Months
Ended March 31,

 

 

 

2022

 

 

2021

 

Net loss

 

$

(12,087

)

 

$

(9,734

)

Weighted average number shares
   outstanding, basic and diluted

 

 

21,083,473

 

 

 

9,100,273

 

Net loss income per common, basic
   and diluted

 

$

(0.57

)

 

$

(1.07

)

Diluted net loss per share of common stock is the same as basic net loss per share of common stock for all periods presented. The following shares were excluded from the calculation of diluted net loss per share, prior to the use of the treasury stock method or if-converted method, because their effect would have been anti-dilutive for the period presented:

11


Potential Dilutive Shares

 

 

 

For the Three Months
Ended March 31,

 

 

 

2022

 

 

2021

 

Common stock warrants

 

 

104,736

 

 

 

93,330

 

Stock options and RSUs

 

 

2,254,579

 

 

 

1,241,435

 

3. In process R&D (IPRD) and intangible assets, net

 

 

March 31, 2022

 

 

December 31, 2021

 

 

 

Indefinite-lived assets

 

 

Definite-lived assets

 

 

Indefinite-lived assets

 

 

Definite-lived assets

 

 

 

Goodwill

 

 

In-process R&D

 

 

In-process R&D

 

 

Goodwill

 

 

In-process R&D

 

 

In-process R&D

 

Cost

 

$

14,772

 

 

$

18,607

 

 

$

4,431

 

 

$

14,898

 

 

$

18,961

 

 

$

4,473

 

Less: accumulated amortization

 

 

 

 

 

 

 

 

200

 

 

 

 

 

 

 

 

 

130

 

Less: impairments

 

 

 

 

 

4,411

 

 

 

 

 

 

 

 

 

4,539

 

 

 

 

 

 

$

14,772

 

 

$

14,196

 

 

$

4,231

 

 

$

14,898

 

 

$

14,422

 

 

$

4,343

 

$0.1 million and zero amortization was recorded for the three months ended March 31, 2022 and 2021 respectively.

4. Property, Plant and Equipment, net

Property, plant and equipment, net consisted of the following (in thousands):

Property, Plant and Equipment, net

 

 

 

March 31,

 

 

December 31,

 

 

 

2022

 

 

2021

 

Leasehold improvements

 

$

150

 

 

$

154

 

Laboratory equipment

 

 

2,164

 

 

 

2,227

 

Furniture and office equipment

 

 

157

 

 

 

162

 

 

 

 

2,471

 

 

 

2,543

 

Less: Accumulated depreciation

 

 

1,728

 

 

 

1,656

 

 

 

$

743

 

 

$

887

 

Depreciation expense for the three months ended March 31, 2022 and 2021 was $0.1 million and $0.1 million, respectively.

5. Fair Value Measurements

The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):

 

 

Fair Value Measurements as of March 31, 2022 Using:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Contingent value rights

 

$

 

 

$

 

 

$

3,659

 

 

$

3,659

 

 

 

$

 

 

$

 

 

$

3,659

 

 

$

3,659

 

12


 

 

Fair Value Measurements as of December 31, 2021 Using:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Contingent value rights

 

$

 

 

$

 

 

$

3,601

 

 

$

3,601

 

 

 

$

 

 

$

 

 

$

3,601

 

 

$

3,601

 

The following table reflects the change in the Company’s Level 3 liabilities, which consists of warrants, for the three months ended March 31, 2022 (in thousands):

Change in Level 3 Liabilities

 

 

 

Contingent Value
Rights

 

Balance at December 31, 2021

 

$

3,601

 

Change in fair value of CVR

 

 

58

 

Balance at March 31, 2022

 

$

3,659

 

The fair value of the CVR liability represents the future payments that are contingent upon the achievement of specific sale or licensing events for the Company’s STimulator of INterferon Gene (“STING”) product candidates, and is based on the Company’s behalfprobability-weighted discounted cash flow assessment that considers probability and timing of future payments. The fair value measurement is based on significant Level 3 unobservable inputs, such as the probability of achieving a sale, licensing agreement or development and regulatory milestones, anticipated timelines, and discount rate. The current liability of the CVR was $1.9 million at both March 31, 2022 and December 31, 2021, and the long term liability was $1.7 million as of March 31, 2022 and December 31, 2021. Changes in the fair value of the liability will be recognized in the consolidated statement of operations and comprehensive loss until settlement.

6. Accrued Expenses and other Current Liabilities

Accrued expenses as of March 31, 2022 and December 31, 2021, consisted of the following (in thousands):

 

 

March 31,

 

 

December 31,

 

 

 

2022

 

 

2021

 

Clinical trial costs

 

$

3,081

 

 

$

2,834

 

Compensation and benefits

 

 

958

 

 

 

1,819

 

Professional fees

 

 

948

 

 

 

1,135

 

Other

 

 

524

 

 

 

453

 

Total

 

$

5,511

 

 

$

6,241

 

7. Term Debt

On April 1, 2021, the Company, as borrower, entered into a Venture Loan and Security Agreement (the “Loan and Security Agreement”) with Horizon Technology Finance Corporation (“Horizon”), as lender and collateral agent for itself. The Loan and Security Agreement provides for four separate and independent $2.5 million term loans (Loan A, Loan B, Loan C, and Loan D, collectively, the “Term Loans”), whereby, upon the satisfaction of all the conditions to the funding of the Term Loans, each Term Loan was funded by Horizon to the Company in the following manner: (i) Loan A was delivered by Horizon to the Company by April 1, 2021, (ii) Loan B was delivered by Horizon to the Company by April 1, 2021, (iii) Loan C was delivered by Horizon to the Company by June 30, 2021, and (iv) Loan D was delivered by Horizon to the Company by June 30, 2021. The Company may only use the proceeds of the Term Loans for working capital or general corporate purposes as contemplated by the Loan and Security Agreement. On April 1, 2021, the Company drew down $5 million. On June 22, 2021, the Company drew down another $5 million under this facility. The Company incurred $0.3 million of debt issuance costs and issued $0.3 million of warrants.

13


The Term Loans mature on the 48-month anniversary following the funding date, therefore $5 million plus an additional fee of $0.2 million becomes due on April 1, 2025, and $5 million plus an additional fee of $0.2 million will become due on June 22, 2025. The principal balance of the Term Loan bears a floating interest. The interest rate is calculated initially and, thereafter, each calendar month as the sum of (a) the per annum rate of interest from time to time published in The Wall Street Journal as contemplated by the Loan and Security Agreement, or any successor publication thereto, as the “prime rate” then in effect, plus (b) 6.25%; provided that, in the event such rate of interest is less than 3.25%, such rate shall be deemed to be 3.25% for purposes of calculating the interest rate. Interest is payable on a monthly basis based on each Term Loan principal amount outstanding the preceding month and at March 31, 2022 the rate applied was 9.5%.

The Company may, at its option upon at least five business days’ written notice to Horizon, prepay all or any portion of the outstanding Term Loan by simultaneously paying to Horizon an amount equal to (i) any accrued and unpaid interest on the outstanding principal balance of the Term Loan so prepaid; plus (ii) an amount equal to (A) if such Term Loan is prepaid on or before the Loan Amortization Date (as defined in the Loan and Security Agreement) applicable to such Term Loan, three percent of the then outstanding principal balance of such Term Loan, (B) if such Term Loan is prepaid after the Loan Amortization Date applicable to such Term Loan, but on or before the date that is 12 months after such Loan Amortization Date, two percent of the then outstanding principal balance of such Term Loan, or (C) if such Term Loan is prepaid more than 12 months after the Loan Amortization Date applicable to such Term Loan, one percent of the then outstanding principal balance of such Term Loan; plus (iii) the outstanding principal balance of such Term Loan; plus (iv) all other sums, if any, that had become due and payable under the Loan and Security Agreement.

The Company’s debt obligation consisted of the following (in thousands):

Term Debt

 

 

 

March 31,
2022

 

 

December 31,
2021

 

Term Loan A and B due April 2025

 

$

5,000

 

 

$

5,000

 

Term Loan C and D due June 2025

 

 

5,000

 

 

 

5,000

 

Term debt

 

 

10,000

 

 

 

10,000

 

Less: Unamortized deferred issuance costs

 

 

(180

)

 

 

(197

)

Less: Warrant discount and interest

 

 

(145

)

 

 

(198

)

Total debt obligations- long term

 

$

9,675

 

 

$

9,605

 

8. Stockholders’ Equity

Common Stock

On August 13, 2021, the Company entered into a Sales Agreement (the “2021 Sales Agreement”) with SVB Securities LLC with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $50.0 million through SVB Securities LLC as its sales agent. During the quarter ended March 31, 2022, the Company had sold 545,054 shares of common stock under the 2021 Sales Agreement for gross proceeds of $2.2 million, resulting in net proceeds of $2.1 million after deducting sales commissions.

9. Warrants

In 2019, Spring Bank, as borrower, entered into a loan and security agreement with Pontifax Medison Finance (Israel) L.P. and Pontifax Medison Finance (Cayman) L.P., as lenders, and pursuant to which Spring Bank issued to Pontifax Medison Finance GP, L.P warrants to purchase 62,500 shares of its common stock (the “Pontifax Warrants”). The Pontifax Warrants are exercisable at $8.32 per share and expire on September 19, 2025. The Company evaluated the terms of the warrants and concluded that they should be equity-classified. At March 31, 2022, there were 62,500 warrants outstanding.

14


In connection with the entry into the Loan and Security Agreement (refer to Note 7), the Company issued to Horizon warrants to purchase an aggregate number of shares of the Company’s common stock in an amount equal to $100,000 divided by the exercise price for each respective warrant. If at any time the Company files a registration statement relating to an offering for its own account, or the account of others, of any of its equity securities, the Company has agreed to include such number of shares underlying the warrants in such registration statement as requested by the holder. The warrants, which are exercisable for an aggregate of 42,236 shares, will be exercisable for a period of seven years at a per-share exercise price of $9.47, which is equal to the 10-day average closing price prior to January 15, 2021, the date on which the term sheet relating to the Loan and Security Agreement was entered into, subject to certain adjustments as specified in the warrant. As of March 31, 2022, there were 42,236 warrants outstanding.

A summary of the warrant activity for the three months ended March 31, 2022, is as follows:

Warrants
Outstanding

Outstanding at December 31, 2021

104,736

Exercises

0

Issued

0

Expired

0

Outstanding at March 31, 2022

104,736

10. Stock Option Plans

Incentive Plans

The Company maintains two equity incentive plans (the "Plans") that provide for the granting of stock options, share appreciation rights, restricted shares, restricted share units, performance share units and certain other share based awards as provided in the Plans to certain employees, members of the board of directors, consultants or other service providers of the Company, with a prescribed contractual term not to exceed ten years. As of March 31, 2022, there were 152,681 shares of common stock available for grant under the Plans. Awards granted under the Plans generally vest over a four-year period with 25% or 28% of the award vesting on the first anniversary of the commencement date and the balance vesting monthly over the remaining three years. Grants are generally awarded with a contractual terms of 10 years from the date of the grant. For certain senior members of management and directors, the board of directors approved an alternative vesting schedule. The share reserve under one of the Plans automatically increases on January 1 each year, in an amount equal to 4% of the total number of shares outstanding as of December 31 of the preceding year.

In March 2022, the Company's Compensation Committee of the Board of Directors approved the issuance of nonqualified stock option awards to purchase Common Stock outside of the aforementioned Plans ("Inducement Awards") to employees to induce them to accept employment with the Company. The terms and vesting conditions of Inducement Awards are the same as for options granted under the Plans.

Stock option valuation

The fair value of stock option grants is estimated using the Black-Scholes option-pricing model with the following assumptions:

 

 

Black-Scholes Option-
Pricing

 

 

 

March 31,
2022

 

 

December 31,
2021

 

Risk-free interest rate

 

1.60% - 2.41%

 

 

0.42% - 1.34%

 

Expected volatility

 

95.51% - 97.42%

 

 

97.18% - 98.96%

 

Expected dividend yield

 

 

0

%

 

 

0

%

Expected life (in years)

 

 

6.1

 

 

 

6.1

 

15


The table below summarizes stock option activity under the Company’s stock option plans and Inducement Awards:

Stock Option Activity

 

 

 

Number of
Shares

 

 

Weighted
Average
Exercise
Price

 

 

Weighted
Average
Contractual
Term

 

 

Aggregate
Intrinsic
Value

 

 

 

 

 

 

 

 

 

(in years)

 

 

(in thousands)

 

Outstanding as of December 31, 2021

 

 

1,098,134

 

 

$

5.80

 

 

 

8.76

 

 

$

5,808

 

Granted

 

 

934,464

 

 

 

4.20

 

 

 

10.00

 

 

 

(861

)

Exercised

 

 

0

 

 

 

0

 

 

 

 

 

 

0

 

Forfeited and expired

 

 

(3,395

)

 

 

8.30

 

 

 

8.97

 

 

 

5

 

Outstanding as of March 31, 2022

 

 

2,029,203

 

 

 

5.06

 

 

 

9.12

 

 

 

4,952

 

Options exercisable at March 31, 2022

 

 

497,046

 

 

 

6.20

 

 

 

8.30

 

 

 

3,260

 

The weighted average grant date fair value of options granted during the three months ended March 31, 2022 and 2021 was $3.27 and $6.70 per share, respectively. The total fair value of options vested during the three months ended March 31, 2022 and 2021 was $6.3 million and $2.8 million, respectively.

Restricted Stock Units

The following table summarizes the movement in the number of Restricted Stock Units (“RSUs”) issued by the Company under the Stock Incentive Plans The table below summarizes activity relating to RSUs for the three months ended March 31, 2022:

RSU Activity

 

 

 

Restricted
Stock Units

 

 

Weighted-
Average
Grant Date
Fair Value

 

Total nonvested units at December 31, 2021

 

 

291,886

 

 

$

9.06

 

Granted

 

 

25,000

 

 

 

2.91

 

Vested

 

 

(91,510

)

 

 

8.72

 

Total nonvested units at March 31, 2022

 

 

225,376

 

 

$

8.51

 

The vesting for the time-based RSUs occurs either immediately, after one year or after four years. For the three months ended March 31, 2022 and March 31, 2021, the Company recognized approximately $0.3 million and $0.9 million in expenses related to the time-based RSUs respectively.

Share-based Compensation

The Company recorded share-based compensation expense in the following expense categories for the three months ended March 31, 2022 and 2021 of its consolidated statements of operations and comprehensive loss (in thousands):

Share-Based Compensation

 

 

 

For the Three Months
Ended March 31,

 

 

 

2022

 

 

2021

 

Research and development expenses

 

$

454

 

 

$

414

 

General and administrative expenses

 

 

1,000

 

 

 

1,766

 

Total

 

$

1,454

 

 

$

2,180

 

At March 31, 2022, there was $5.1 million of unrecognized stock-based compensation expense relating to stock options granted pursuant to the Stock Incentive Plans, which will be recognized over the weighted-average remaining vesting period of 3.3 years.

16


At March 31, 2022, there was $1.6 million of unrecognized stock-based compensation expense relating to the time-based RSUs granted pursuant to the Stock Incentive Plans, which will be recognized over the weighted-average remaining vesting period of 2.9 years.

11. Significant Agreements

License and Collaboration agreements

For the three months ended March 31, 2022 and 2021, the Company had License and Collaboration agreements (“LCAs”) with Ares, Denali, Janssen and AstraZeneca. The following table summarizes the revenue recognized in the Company’s consolidated statements of operations and comprehensive loss from these arrangements (in thousands):

Revenue by Collaboration Partner

 

 

 

For the Three Months
Ended March 31,

 

 

 

2022

 

 

2021

 

Ares

 

$

2,551

 

 

 

2,800

 

Denali

 

 

0

 

 

 

117

 

Total

 

$

2,551

 

 

$

2,917

 

2019 License and collaboration agreement with Ares Trading S.A.

Summary

On May 14, 2019, the Company entered into a licensing and collaboration agreement ("2019 LCA") with Ares, pursuant to which the Company granted the option to enter into a worldwide, exclusive license to certain patents and know-how to develop, manufacture and commercialize two separate mAb2 antibody products that each contain a specific Fcab and a Fab target pair (each a licensed product).

For the exclusive rights granted in relation to the first molecule, an option fee of $11.1 million was paid by Ares to the Company. Following receipt of the option fee, Ares became responsible for the development of the molecule and development, regulatory and sales-based royalties become payable to Company upon achievement of specified events.

On July 15, 2020, a deed of amendment (the “2020 Amendment”) was entered into in respect of the 2019 LCA. The 2020 Amendment had two main purposes: (i) to grant additional options to acquire intellectual property rights for a third and fourth molecule; and (ii) to allow Ares to exercise its option early to acquire intellectual property rights to the second molecule included in the 2019 LCA as well as to terminate the research and development services. On execution of the amendment, an option fee of $8.5 million was paid by Ares to the Company to acquire rights to the second molecule.

During March 2021, Ares paid an option fee of $2.7 million to acquire the rights to the third molecule.

As a result of the 2020 Amendment, the maximum amount payable by Ares on the achievement of certain development and regulatory milestones in the aggregate was increased to $473.9 million, and the maximum amount payable on the achievement of certain commercial milestones was increased to $292.3 million. In addition, to the extent that any product candidates covered by the exclusive licenses granted to Ares are commercialized, the Company will be entitled to receive a single digit royalty based on a percentage of net sales on a country-by-country basis.

Revenue recognition

Management has considered the performance obligations identified in the Ares LCA and concluded that the option for the grant of intellectual property rights is not distinct from the provision of R&D services, as the R&D services would significantly modify the early-stage intellectual property. As a result, the option for the grant of intellectual property rights and the provision of R&D services has been combined into a single performance obligation for each individual molecule included in the 2019 LCA. The Company recognized revenue using the cost-to-cost method, which it believes best depicted the transfer of control of the services to the customer. Under the cost-to-cost method,

17


the extent of progress towards completion is measured based on the ratio of actual costs incurred to the total estimated costs expected upon satisfying the identified performance obligation.

The total transaction price for the 2019 LCA, was initially determined to be $15.4 million, consisting of the upfront payment for the first molecule and research and development funding for the research term for the second molecule. Variable consideration to be paid to the company upon reaching certain milestones had been excluded from the calculation, as at the inception of the contract, it was not probable that a significant reversal of revenue recognized would not occur in a subsequent reporting period.

There were two components identified in the 2020 Amendment, each of which was accounted for as a separate performance obligation. The first component, the grant of the additional options to acquire intellectual property rights for the third and fourth molecule, was deemed to be distinct, as the customer can benefit from it on its own, and it is independent of the delivery of other performance obligations in the 2019 LCA. Additionally, as the amount of consideration reflects a standalone selling price, the Company determined that the second component is accounted for as a separate contract.

The second component, which allowed the customer to exercise its option to acquire intellectual property rights to the second molecule early, is considered to be a modification of the 2019 LCA. This is because the option is not independent of the research and development services provided under the 2019 LCA, and therefore the goods and services are not distinct. All performance obligations under the 2019 LCA in respect of the second molecule were deemed to have been fully satisfied on July 15, 2020. The Company updated the transaction price to $22.4 million on execution of the 2020 Amendment, due to the addition of $8.5 million for the option exercise for the second molecule and a reduction in research and development services of $1.5 million, due to the early termination of the services.

For the three months ended March 31, 2021, $2.7 million was recognized in relation to the option exercise to acquire intellectual property rights for the third molecule included in the 2020 Amendment.

During the three months ended March 31, 2022, Ares provided notice of its intention to exercise its option to acquire the intellectual property rights for the fourth molecule included in the 2020 Amendment and $2.6 million was recognized at a point in time in respect of the option exercise.

License and collaboration agreement with Denali Therapeutics, Inc.

Summary

In August 2016, the Company entered into an exclusive license and collaboration agreement (the “Denali LCA”) with Denali. Under the terms of the Denali LCA, Denali was granted the right to nominate up to three Fcab targets for approval (“Accepted Fcab Targets”), within the first three years of the date of the agreement. Upon entering into the Denali LCA, Denali had selected Transferrin receptor as the first Accepted Fcab Target and paid an upfront fee of $5.5 million to the Company. In May 2018, Denali exercised its right to nominate two additional Fcab targets and identified a second Accepted Fcab Target. Denali made a one-time payment to the F-star group for the two additional Accepted Fcab Targets of $6.0 million and extended the time period for its selection of the third Accepted Fcab Target until August 2020.

Under the terms of the agreement the Company is entitled to receive contingent payments that relate to certain defined preclinical, clinical, regulatory, and commercial milestones with a maximum value of $49.5 million.

Revenue recognition

The Company has considered the performance obligations identified in the contracts and concluded that the grant of intellectual property rights is not distinct from the provision of R&D services, as the R&D services are expected to significantly modify the early-stage intellectual property. As a result, the grant of intellectual property rights and the provision of R&D services has been combined into a single performance obligation for this contract.

The initial transaction price for the first Accepted Fcab Target was deemed to be $7.1 million consisting of $5.0 million for the grant of intellectual property rights and $2.1 million for R&D services. The initial transaction price for the second Accepted Fcab Target was $5.1 million, consisting of $3.0 million for the grant of intellectual property rights and $2.1 million for R&D services. During the year ended December 31, 2019, the transaction price for the first Accepted Fcab Target was increased to $8.6 million due to achievement of a $1.5 million milestone that

18


on initial recognition of the Denali LCA was not included in the transaction price, as it was not deemed probable that a reversal would not occur in a future reporting period.

All performance obligations were deemed to have been fully satisfied during the year ended December 31, 2019 in respect of the first Accepted Fcab Target, and during the three months ended March 30, 2021 in respect of the second Accepted Fcab Target. For the three months ended March 31, 2022 and 2021, the Company recognized 0 and $0.1 million, respectively in respect of the second Accepted Fcab Target.

2021 Agreement with AstraZeneca

Summary

On July 7, 2021 the Company entered into a License Agreement with AstraZeneca. Under the terms of the agreement the Company has granted an exclusive license to certain patents and know-how to develop, manufacture and commercialize STING inhibitor compounds. AstraZeneca will be responsible for all future research, development and commercialization activities.

For the exclusive rights granted, an initial upfront fee of $0.5 million was paid by AstraZeneca to the Company during the three months ended September 2021. The Company is entitled to receive additional contingent near-term preclinical milestones of $11.5 million, plus maximum contingent payments that relate to certain defined development and regulatory milestones of $85.0 million and commercial milestones of $221.3 million, as well as royalty payments based upon a single digit percentage on net sales of products developed. Pursuant to the STING Antagonist CVR Agreement, 80% of net proceeds received the Company under the License Agreement with AstraZeneca will be payable, pursuant to the Exchange Agreement, to common stockholders of Spring Bank as of November 19, 2020, immediately prior to the Closing of the transaction.

Revenue recognition

Management has identified a single performance obligation in the contract, which is the grant of intellectual property rights.

The total transaction price was initially determined to be $0.5 million, consisting only of the upfront payment. Variable consideration to be paid to the company upon reaching certain milestones has been excluded from the calculation, as at the inception of the contract, it is not probable that a significant reversal of revenue recognized would not occur in a subsequent reporting period. The transaction price was allocated to the single performance obligation, which was deemed to be fully satisfied on the grant of intellectual property rights, and therefore the initial upfront fee was recognized at a point in time.

NaN revenue was recorded for this contract in the three months ended March 31, 2022 or March 31, 2021.

2021 License and Collaboration Agreement with Janssen Biotech, Inc.

On October 19, 2021, we entered into a license and collaboration agreement (the “Janssen Agreement”) with Janssen. The Janssen Agreement was facilitated by Johnson & Johnson Innovation.

Under the Janssen Agreement, Janssen received a worldwide exclusive license to research and develop and the option to commercialize up to five novel bispecific antibodies directed to Janssen therapeutic targets using F-star’s proprietary Fcab and mAb2platforms. Janssen is responsible for all research, development, and commercialization activities under the Janssen Agreement.

F-star received upfront fees of $17.5 million, and is entitled to receive near-term fees and potential further milestones of up to $1.35 billion. F-star is also eligible to receive potential tiered mid-single digit royalties on annual net sales of any products that receive regulatory approval and are commercialized using the licensed technology.

Revenue recognition

19


The Company assessed the arrangement in accordance with ASC 606 and concluded that Janssen is a customer based on the arrangement structure. The Company identified a single performance obligation under the arrangement consisting of the grant of intellectual property rights at the inception of the Janssen Agreement. There are no R&D services included in the arrangement or needed for Janssen to use the technology.

Revenue is recognized as functional IP, at the point in time when control of the license is transferred.

The Company determined that the transaction price at the onset of the arrangement is the total upfront payment received in the amount of $17.5 million. The transaction price was allocated to the single performance obligation, which was deemed to be fully satisfied upon the grant of intellectual property rights, and therefore the initial upfront fee was recognized at a point in time. Separately, we also identified customer options, which include our obligations to grant an additional 18-month period to the research license granted at contract inception and to grant exploitation licenses for up to five subject mAb2 molecules. These options do not represent a material right, as they are not offered at a significant and incremental discount, and will be recorded as separate contracts when and if they are executed.

NaN revenue was recorded for this contract in the three months ended March 31, 2022 or March 31, 2021.

Summary of Contract Assets and Liabilities

Up-front payments and fees are recorded as deferred revenue upon receipt or when due until such time as the Company satisfies its performance obligations under these arrangements. A contract asset is a conditional right to consideration in exchange for goods or services that the Company has transferred to a customer. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional.

The following table presents changes in the balances of the Company’s contract liabilities (in thousands):

 

 

Deferred
revenue
balance at
January 1,
2022

 

 

Additions

 

 

Revenue
recognized

 

 

Impact of
exchange
rates

 

 

Deferred
revenue
balance at
March 31,
2022

 

Deferred revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ares collaboration

 

$

0

 

 

$

0

 

 

$

0

 

 

$

0

 

 

$

0

 

Denali collaboration

 

 

0

 

 

 

0

 

 

 

0

 

 

 

0

 

 

 

0

 

Total deferred revenue

 

$

0

 

 

$

0

 

 

$

0

 

 

$

0

 

 

$

0

 

 

 

Deferred
revenue
balance at
January 1,
2021

 

 

Additions

 

 

Revenue
recognized

 

 

Impact of
exchange
rates

 

 

Deferred
revenue
balance at
March 31,
2021

 

Deferred revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ares collaboration

 

$

37

 

 

$

0

 

 

$

(37

)

 

$

 

 

$

0

 

Denali collaboration

 

 

263

 

 

 

0

 

 

 

(117

)

 

 

(146

)

 

 

0

 

Total deferred revenue

 

$

300

 

 

$

0

 

 

$

(154

)

 

$

(146

)

 

$

0

 

During the three months ended March 31, 2021, all revenue recognized by the Company as a result of changes in the contract liability balances in the respective periods was based on proportional performance.

12. Commitments and Contingencies

Lease Obligations

On January 27, 2021, the Company signed an operating lease for three years for its corporate headquarters in Cambridge, UK. The Company also has leases for the former Spring Bank headquarters and laboratory space in Hopkinton, Massachusetts which are or were being subleased. One of the two leases expired on May 31, 2021 and

20


the remaining lease has a remaining term of approximately 6.8 years for its former principal office and laboratory space, which includes an option to extend the lease for up to 5 years. The Company’s former headquarters location is being subleased through the remainder of the lease term.

Operating lease costs under the leases for the three months ended March 31, 2022, and 2021 were approximately $0.2 million and $0.3 Million.

The following table summarizes the Company’s maturities of operating lease liabilities as of March 31, 2022 (in thousands):

Maturities of Operating Lease Liabilities

 

Periods

 

 

 

For the period April 1, 2022 to December 31, 2022

 

$

671

 

2023

 

 

905

 

2024

 

 

393

 

2025

 

 

382

 

2026

 

 

372

 

Thereafter

 

 

657

 

Total lease payments

 

$

3,380

 

Sublease

The Company subleases the former Spring Bank offices in Hopkinton, Massachusetts. Operating sublease income under operating lease agreements for the three months ended March 31, 2022, and 2021 was $0.1 million and $0.1 million. This sublease has a remaining lease term of 6.6 years. Future expected cash receipts from our sublease as of March 31, 2022, are as follows (in thousands):

Future Expected Cash Receipts From Sublease

 

Period

 

 

 

For the period April 1, 2022 to December 31, 2022

 

$

349

 

2023

 

 

474

 

2024

 

 

486

 

2025

 

 

498

 

2026

 

 

511

 

Thereafter

 

 

970

 

Total sublease receipts

 

$

3,288

 

Service Agreements

As of March 31, 2022, the Company had contractual commitments of $4.7 million with a contract manufacturing organizations,organization (“CMO”) for activities that are ongoing or CMOs,are scheduled to start between three and nine months of the date of the statement of financial position. Under the terms of the agreement with the CMO, the Company is committed to pay for some activities if those activities are cancelled up to three, six or nine months prior to the commencement date.

13. Subsequent Events

During April 2022, the Company issued and sold 80,558 ordinary shares, pursuant to its ATM program for gross proceeds of $0.30 million, resulting in net proceeds of $0.29 million after deducting sales commissions and offering expenses of $0.01 million.

21


Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following information should be read in conjunction with the unaudited financial information and the notes thereto included in this Quarterly Report on Form 10-Q and the consolidated financial statements and notes thereto for the year ended December 31, 2021, and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, contained in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 15, 2022.

Our actual results and the timing of certain events may differ materially from the results discussed, projected, anticipated, or indicated in any forward-looking statements due to various important factors, risks and uncertainties, including, but not limited to, those set forth under “Forward-Looking Statements” included elsewhere in this Quarterly Report on Form 10-Q or under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 15, 2022, as may be updated by Part II, Item 1A, Risk Factors of our subsequently filed Quarterly Reports on Form 10-Q. We caution our readers that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from those expressed or implied by the forward-looking statements contained in this Quarterly Report on Form 10-Q.

We caution readers not to place undue reliance on any forward-looking statements made by us, which speak only as of the date they are made. We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

22


FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. In some cases, you can identify forward-looking statements by terms including, but not limited to, “may,” “likely,” “will,” “should,” “would,” “design,” “expect,” “seek,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions.

These forward-looking statements include, but are not limited to, statements about:

the accuracy of our estimates regarding expenses, revenues, uses of cash, cash equivalents and investment securities, capital requirements and the need for additional financing;

our expectations regarding our research, development and commercialization of our product candidates, including FS118, FS222, FS120 and SB 11285;

the duration and severity of the COVID-19 pandemic and its impact on our business, including the impact of COVID-19 on the research, development and commercialization of our product candidates and our ability to adapt our approach as appropriate;

the supply and availability of and demand for our product candidates;

the initiation, cost, timing, progress and results of our development activities, non-clinical studies and clinical trials;

the timing of and our ability to obtain and maintain regulatory approval, or submit an application for regulatory approval, of our product candidates, including FS118, FS222, FS120 and SB 11285, and any product candidates that we may develop, and any related restrictions, limitations, and/or warnings in the label of any approved product candidates;

our plans to research, develop and commercialize our current and future product candidates, including FS118, FS222, FS120 and SB 11285;

the election by any collaborator to pursue research, development and commercialization activities;

our ability to obtain future reimbursement and/or milestone payments from our collaborators;

our ability to attract collaborators with development, regulatory and commercialization expertise;

our ability to obtain and maintain intellectual property protection for our product candidates;

the size and growth of the markets for our product candidates, including FS118, FS222, FS120 and SB 11285, and our ability to serve those markets;

the rate and degree of market acceptance of any future products;

the success of competing drugs that are or become available;

regulatory developments in the United States, European Union and other countries and regulatory bodies;

the performance of our third-party suppliers and manufacturers and our ability to obtain alternative sources of raw materials;

23


our ability to obtain additional financing;

our use of the proceeds from our securities offerings;

any restrictions on our ability to use our net operating loss carryforwards;

our exposure to investment risk, interest rate risk and capital market risk; and

our ability to attract and retain key scientific, management or sales and marketing personnel.

You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. You should also read carefully the factors described in “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC on March 15, 2022, to better understand the risks and uncertainties inherent in our business and underlying any forward-looking statements. You are advised, however, to consult any further disclosures we make on related subjects in our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, press releases, and our website. Any forward-looking statements that we make in this Quarterly Report on Form 10-Q speak only as of the date of this Quarterly Report on Form 10-Q, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q or to reflect the occurrence of unanticipated events.

Overview

F-star Therapeutics, Inc. (collectively with its subsidiaries, “we”, “F-star” or the “Company”) is a clinical-stage biopharmaceutical company dedicated to developing next generation immunotherapies to transform the lives of patients with cancer. F-star is pioneering the use of tetravalent (2+2) bispecific antibodies to create a paradigm shift in cancer therapy. The Company has four second generation immuno-oncology ("IO") therapeutics in the clinic, each directed against some of the most promising IO targets in drug development, including LAG-3 and CD137. F-star’s proprietary antibody discovery platform is protected by an extensive IP estate. F-star has over 500 granted patents and pending patent applications relating to its platform technology and associated product pipeline. The Company has attracted multiple partnerships with biopharma targeting the significant unmet needs across several disease areas, including oncology, immunology, and CNS with over 20 programs being developed by our partners using our technology. F-star’s goal is to offer patients better and more durable benefits than currently available immuno-oncology treatments by developing medicines that seek to block tumor immune evasion. Through its proprietary tetravalent, bispecific natural antibody (mAb²) format, F-star’s mission is to generate highly differentiated medicines with monoclonal antibody-like manufacturability, good safety and tolerability. With four distinct binding sites in a natural human antibody format, we believe our proprietary technology will overcome many of the challenges facing current immuno-oncology therapies, including other bispecific formats, due to the strong pharmacology enabled by tetravalent bispecific binding.

Our Programs

F-star’s most advanced product candidate, FS118, is currently being evaluated in proof-of-concept Phase 2 trials in PD-1/PD-L1 acquired resistance head and neck cancer patients and in checkpoint inhibitor (“CPI”) naïve non-small cell lung cancer (“NSCLC”) and diffuse large B-cell lymphoma (“DLBCL”) patients. FS118 is a tetravalent mAb2 bispecific antibody targeting two receptors, PD-L1 and LAG-3, both of which are validated targets in immuno-oncology. Phase 1 data from 43 heavily pre-treated patients with advanced cancer, who have failed PD-1/PD-L1 therapy, showed that administration of FS118 was well-tolerated with no dose limiting toxicities up to 20 mg/kg. In addition, a disease control rate (“DCR”), defined as either a complete response, partial response or stable disease, of 49% (19 out of 39) was observed in patients receiving dose levels of FS118 of 1mg/kg or greater. In acquired resistance patients, the DCR was 55% (17 out of 31) in patients receiving 1 mg/kg or greater and long-term (more than six months) disease control was observed in six of these patients. We expect to provide an update from the proof-of-concept Phase 2 trial in PD-1/PD-L1 acquired resistance head and neck cancer patients in mid-2022. Data reported during the first half of 2021, from a randomized Phase 3 trial conducted by another company in patients with previously untreated, locally advanced or metastatic melanoma provides clinical validation for the combination

24


of LAG-3 and PD-1 inhibition. This clinical benefit in targeting PD-1 and LAG-3 gives us reason to believe that FS118 has potential to benefit patients not only with acquired resistance, but also in preventing resistance in patients receiving PD-1 monotherapy for the first time. With respect to the latter, we initiated a clinical trial of FS118 in CPI-naïve patients in biomarker enriched NSCLC and DLBCL populations in late 2021.

F-star’s second product candidate, FS222, aims to improve outcomes particularly in patients with tumors that express low levels of PD-L1 and is a mAb2 bispecific antibody that is designed to target both the costimulatory CD137 and the inhibitory PD-L1 ligand, which are co-expressed in many tumor types. The Phase 1 clinical trial evaluating FS222 in patients with advanced cancers is ongoing. We believe there is a strong rationale to combine FS222 with other anti-cancer agents, and this can be done within the Phase 1 study. The accelerated dose titration was completed in the second half of 2021, and identification of optimal patient groups, dose and schedule is on-going. We expect to provide an update on the progress of the Phase 1 trial and report safety, biomarker and preliminary efficacy data in the second half of 2022.

F-star’s third product candidate, FS120, aims to improve checkpoint inhibitor and chemotherapy outcomes and is a mAb2bispecific antibody that is designed to bind to and stimulate OX40 and CD137, two proteins found on the surface of T cells that both function to enhance T cell activity. F-star is developing FS120 alone and in combination with PD-1 therapy for the treatment of tumors where PD-1 inhibitors are approved, and which have been associated with co-expression of OX40 and CD137 in the tumor microenvironment. The Phase 1 clinical trial in patients with advanced cancers is ongoing and we completed the accelerated dose titration phase during the second half of 2021. We are continuing further dose escalation to determine an optimal dosing regimen to initiate a combination of FS120 and the PD-1 inhibitor, pembrolizumab, in the second half of 2022. Pembrolizumab will be supplied under clinical trial collaboration and supply agreement with Merck & Co.

SB 11285, which F-star acquired pursuant to a business combination with Spring Bank Pharmaceuticals, Inc. (“Spring Bank”), is a next generation cyclic dinucleotide STimulator of INterferon Gene (“STING”) agonist designed to improve checkpoint inhibition outcomes as an immunotherapeutic compound for the treatment of selected cancers. SB 11285 appeared to be well tolerated both alone and in combination with atezolizumab across all dose levels tested to-date, including five dose levels as monotherapy and three dose levels as a combination. Initial analysis showed that pharmacokinetics (PK) were in-line with the predicted profile for rapid cellular uptake, a characteristic of second generation STING agonists. F-star is continuing with further dose-escalation and in parallel pursuing strategic business development opportunities for SB 11285. We expect to report an update on this study in the second half of 2022.

Share Exchange Agreement

On November 20, 2020, the Company, formerly known as Spring Bank, completed a business combination (the “Transaction”) with F-star Therapeutics Limited (“F-star Ltd”) in accordance with the terms of the Share Exchange Agreement, dated July 29, 2020 (the “Exchange Agreement”), by and among the Company, F-star Ltd and certain holders of the capital stock and convertible notes of F-star Ltd (each a “Seller”, and collectively with holders of F-star Ltd securities who subsequently became parties to the Exchange Agreement, the “Sellers”). Pursuant to the Exchange Agreement, each ordinary share of F-star Ltd outstanding immediately prior to the closing of the Transaction (the “Closing”) was exchanged by the Sellers that owned such F-star Ltd shares for a number of duly authorized, validly issued, fully paid and non-assessable shares of Company common stock pursuant to an exchange ratio formula as set forth in the Exchange Agreement (the “Exchange Ratio”), rounded to the nearest whole share of Company common stock (after aggregating all fractional shares of Company common stock issuable to such Seller). Also, on November 20, 2020, in connection with, and prior to completion of, the Transaction, Spring Bank effected a 1-for-4 reverse stock split of its common stock (the “Reverse Stock Split”) and, following the completion of the Transaction, changed its name to F-star Therapeutics, Inc. Following the completion of the Transaction, the business of the Company became the business conducted by F-star, which is a clinical-stage immuno-oncology company focused on cancer treatment through its proprietary tetravalent bispecific antibody programs. Unless otherwise noted, all references to share amounts in this report reflect the Reverse Stock Split.

Under the terms of the Exchange Agreement, at the Closing, Spring Bank issued an aggregate of 4,620,618 shares of its common stock to F-star Ltd stockholders, based on an Exchange Ratio of 0.1125 shares of Spring Bank common stock for each F-star Ltd ordinary share, stock option and restricted stock unit (“RSU”) outstanding immediately

25


prior to the Closing. The Exchange Ratio was determined through arms-length negotiations between Spring Bank and F-star Ltd pursuant to a formula set forth in the Exchange Agreement.

Pursuant to the Exchange Agreement, immediately prior to the Closing, certain investors in F-star Ltd purchased $15.0 million of F-star Ltd ordinary shares (the “Pre-Closing Financing”). These ordinary shares of F-star Ltd were then exchanged at the Closing for shares of the Company’s common stock in the Transaction at the Exchange Ratio.

Pursuant to the Exchange Agreement, all outstanding options to purchase Spring Bank common stock were accelerated immediately prior to the Closing and each outstanding option with an exercise price greater than the closing price of the stock on the Closing Date was exercised in full and all other outstanding options to purchase Company common stock were cancelled effective as of the Closing Date.

Immediately following the Reverse Stock Split and the Closing, there were approximately 4,449,559 shares of Spring Bank common stock outstanding. Following the Closing, the F-star Ltd stockholders beneficially owned approximately 53.7% of the combined company’s common stock, and the existing stockholders of Spring Bank beneficially owned approximately 46.3% of the combined company’s common stock. Concurrently with the execution of the Exchange Agreement, certain officers and directors of Spring Bank and F-star Ltd and certain stockholders of F-star Ltd entered into lock-up agreements, pursuant to which they agreed to certain restrictions on transfers of any shares of the Company’s common stock for the 180-day period following the Closing, other than the shares of the Company’s common stock received in exchange for ordinary shares of F-star Ltd subscribed for in the Pre-Closing Financing and pursuant to certain other limited exceptions.

In addition, at the Closing, Spring Bank, F-star Ltd, a representative of Spring Bank stockholders prior to the Closing, and Computershare Trust Company N.A., as the Rights Agent, entered into a STING Agonist Contingent Value Rights Agreement (the “STING Agonist CVR Agreement”). Pursuant to the Exchange Agreement and the STING Agonist CVR Agreement, each pre-Reverse Stock Split share of Spring Bank common stock held by stockholders as of the record date on November 19, 2020, immediately prior to the Closing, received a dividend of one contingent value right (“CVR”) (“STING Agonist CVR”), payable on a pre-Reverse Stock Split basis, entitling such holders to receive, in connection with certain transactions involving proprietary STING agonist compound designated as SB 11285 occurring on or prior to the STING Agonist CVR Expiration Date (as defined below) that resulted in aggregate Net Proceeds (as defined in the STING Agonist CVR Agreement) at least equal to the Target Payment Amount (as defined below), an aggregate amount equal to the greater of (i) 25% of the Net Proceeds received from all CVR Transactions (as defined in the STING Agonist CVR Agreement) and (ii) an aggregate amount equal to the product of $1.00 and the total number of shares of Company common stock outstanding as of such record date (not to exceed an aggregate amount of $18.0 million) (the “Target Payment Amount”).

The CVR payment obligation expires on the later of 18 months following the Closing or the one-year anniversary of the date of the final database lock of the STING clinical trial (as defined in the STING Agonist CVR Agreement) (the “STING Agonist CVR Expiration Date”). The final database lock of the STING clinical trial occurred on July 15, 2021. The STING Agonist CVRs are not transferable, except in certain limited circumstances, are not certificated or evidenced by any instrument, do not accrue interest and are not registered with the SEC or listed for trading on any exchange. Until the STING Agonist CVR Expiration Date, subject to certain exceptions, the Company is required to use commercially reasonable efforts to (a) complete the STING Trial and (b) pursue a CVR Transaction. The STING Agonist CVR Agreement became effective upon the Closing and, unless terminated earlier in accordance with its terms, will continue in effect until the STING Agonist CVR Expiration Date the payment or all CVR payment amounts are paid pursuant to their terms.

At the Closing, Spring Bank, F-star Ltd, a representative of Spring Bank stockholders prior to the Closing, and Computershare Trust Company N.A., as the Rights Agent, also entered into a STING Antagonist Contingent Value Rights Agreement (the “STING Antagonist CVR Agreement”). Pursuant to the Exchange Agreement and the STING Antagonist CVR Agreement, each share of common stock held by Spring Bank stockholders as of November 19, 2020, immediately prior to the Closing, received a dividend of one CVR (“STING Antagonist CVR”) entitling such holders to receive, in connection with the execution of a potential development agreement (the “Approved Development Agreement”) and certain other transactions involving proprietary STING antagonist compounds occurring on or prior to the STING Antagonist CVR Expiration Date (as defined below) equal to: 80% of all net proceeds (as defined in the STING Antagonist CVR Agreement) received by the Company after the

26


Closing pursuant to (i) the Approved Development Agreement, if any, and (ii) all CVR Transactions (as defined in the STING Antagonist CVR Agreement) entered into prior to the STING Antagonist CVR Expiration Date.

On July 7, 2021, we entered into a License Agreement with AstraZeneca. Under the terms of the agreement, the Company granted an exclusive license to certain patents and know-how to develop, manufacture drugand commercialize STING inhibitor compounds. AstraZeneca is responsible for all future research, development and commercialization activities.

For the exclusive rights granted, an initial upfront fee of $0.5 million was paid by AstraZeneca to the Company. The Company is entitled to receive additional contingent near-term preclinical milestones of $11.5 million, plus maximum contingent payments that relate to certain defined development and regulatory milestones of $96.5 million and commercial milestones of $221.3 million, as well as royalty payments based upon a single digit percentage on net sales of products developed. Pursuant to the STING Antagonist CVR Agreement, 80% of net proceeds received the Company under the License Agreement with AstraZeneca are payable, pursuant to the Exchange Agreement, to common stockholders of Spring Bank as of November 19, 2020.

The STING Antagonist CVRs are not transferable, except in certain limited circumstances, are not certificated or evidenced by any instrument, do not accrue interest, and are not registered with the SEC or listed for trading on any exchange. Until the STING Antagonist CVR Expiration Date, subject to certain exceptions, the Company is required to use commercially reasonable efforts to (a) consummate the Approved Development Agreement, (b) to perform the terms of the Approved Development Agreement and (c) pursue CVR Transactions. The STING Antagonist CVR Agreement became effective upon the Closing and, unless terminated earlier in accordance with its terms, will continue in effect until the STING Antagonist CVR Expiration Date or all CVR payment amounts are paid pursuant to their terms. On July 8, 2021, the Company entered into a License Agreement with AstraZeneca under which AstraZeneca will receive global rights to research, develop and commercialize next generation STING inhibitor compounds. Under the terms of the agreement, AstraZeneca is granted exclusive access to and will be responsible for all future research, development and commercialization of the STING inhibitor compounds. F-star is eligible to receive upfront and near-term payments of up to $12 million upon meeting certain milestones. In addition, F-star will be eligible for development and sales milestone payments of over $300 million, as well as single digit percentage royalty payments. Payments received by F-star are subject to a contingent value rights agreement (“CVR 2”), under which 80% will be payable to stockholders of F-star that were previously stockholders of Spring Bank prior to the business combination between F-star and Spring Bank.

The acquisition-date fair value of the CVR liability represents the future payments that are contingent upon the achievement of sale or licensing for the product candidates. The fair value of the contingent consideration acquired of $2.5 million as of December 31, 2021, and $3.5 million as of March 31, 2022, is based on the Company’s probability-weighted discounted cash flow assessment that considers probability and timing of future payments. The fair value measurement is based on significant Level 3 unobservable inputs such as the probability of achieving a sale or licensing agreement, anticipated timelines, and discount rate. Changes in the fair value of the liability will be recognized in the consolidated statement of operations and comprehensive loss until settlement. For the three months ended March 31, 2022, the estimated fair value increased to $3.5 million which resulted in a $0.4 million charge on the Consolidated Statements of Operations and Comprehensive Loss.

F-star Ltd was determined to be the accounting acquirer based on an analysis of the criteria outlined in ASC 805 and the facts and circumstances specific to the Transaction, including the fact that immediately following the Transaction: (1) F-star Ltd shareholders owned the majority of the voting rights of the combined company; (2) F-star Ltd designated a majority (five of eight) of the initial members of the board of directors of the combined company; and (3) F-star Ltd senior management held the key positions in senior management of the combined company. As a result, upon consummation of the Transaction, the historical financial statements of F-star Ltd became the historical financial statements of the combined organization.

27


Impact of COVID-19 on our Business

The continued spread of the COVID-19 pandemic has been evolving, and to date has led to the implementation of various responses, including government-imposed quarantines, travel restrictions and other public health safety measures.

Management continues to closely monitor the impact of the COVID-19 pandemic on all aspects of the business, including how it will impact operations and the operations of customers, vendors and business partners. The extent to which COVID-19 impacts the future business, results of operations and financial condition will depend on future developments, which are highly uncertain and cannot be predicted with confidence at this time, such as new information that may emerge concerning the emergence or severity of other strains of COVID-19 or the effectiveness of actions to vaccinate against or contain COVID-19 or treat its impact, among others. If we or any of the third parties with whom we engage, however, were to experience shutdowns or other business disruptions, the ability to conduct business in the manner and on the timelines presently planned could be materially and negatively affected, which could have a material adverse impact on business, results of operations and financial condition. The estimates of the impact on our business may change based on new information that may emerge concerning COVID-19 and the actions to contain it or treat its impact and the economic impact on local, regional, national, and international markets.

Management has not identified any triggering events which would result in any significant impairment losses in the carrying values of assets as a result of the pandemic and are not aware of any specific related event or circumstance that would require management to revise estimates reflected in our consolidated financial statements.

Recent Developments

Subsequent Events

During April 2022, the Company issued and sold 80,558 ordinary shares, pursuant to its ATM program for gross proceeds of $0.30 million, resulting in net proceeds of $0.29 million after deducting sales commissions and offering expenses of $0.01 million.

Components of Operating Results

License revenue

To date, we have not generated any revenue from product sales, and we do not expect to generate any revenue from product sales for the foreseeable future. Our revenue consists of collaboration revenue under our license and collaboration agreements with Ares, Denali, AstraZeneca, Janssen and others, including amounts that are recognized related to upfront payments, milestone payments, option exercise payments, and amounts due to us for research and development services. In the future, revenue may include new collaboration agreements, additional milestone payments, option exercise payments, and royalties on any net product sales under our collaborations. We expect that any revenue we generate will fluctuate from period to period as a result of the timing and amount of license, research and development services, and milestone and other payments.

Operating Expenses

Research and development costs

Research and development costs are expensed as incurred. Research and development expenses are comprised of costs incurred in performing clinical trials, research and development activities, including salaries, share-based compensation expense and benefits, facilities costs and laboratory supplies, depreciation, amortization and impairment expense, manufacturing expenses and external costs of outside vendors engaged to conduct preclinical development activities and clinical trials as well as the cost of licensing technology. Typically, upfront payments and milestone payments made for the licensing of technology are expensed as research and development in the period in which they are incurred, except for payments relating to intellectual property rights with future alternative use which will be expensed when the intellectual property is in use. Non-refundable advance payments for goods or

28


services to be received in the future for use in the Company’s preclinical and clinical trials;

salaries, benefits and other related costs, including stock-based compensation expense, for personnel in the Company’s research and development functions;activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.

Those expenses associated with R&D and clinical costs primarily include:

expenses incurred under agreements with contract research organizations (“CROs”) as well as investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development services;

costs of outside consultants, including their fees, stock-based compensationmanufacturing scale-up expenses and related travel expenses;

the cost of laboratory supplies and acquiring developing and manufacturing preclinical study and clinical trial materials;

costs related to compliance with regulatory requirements; and

expenses incurred for outsourced professional scientific development services;

facility-relatedcosts for laboratory materials and supplies used to support our research activities;

allocated facilities costs, depreciation, and other expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilitiesutilities;
up-front, milestone and other operating costs.

management fees for maintaining licenses under our third-party licensing agreements; and
compensation related expenses

The Company expenses research and development costs as incurred. The Company recognizesWe recognize external developmentR&D costs based on an evaluation of the progress to completion of specific tasks using information provided to the Companyit by its vendorsinternal program managers and its clinical investigative sites. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in the Company’s consolidated financial statements as prepaid or accrued research and development expenses.


Warrantsservice providers.

The Company reviews the terms of all warrants issued and classifies the warrants as a component of permanent equity if they are freestanding financial instruments that are legally detachable and separately exercisable, contingently exercisable, do not embody an obligation for the Company to repurchase its own shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, the warrants must require physical settlement and may not provide any guarantee of value or return. Warrants that meet these criteria are initially recorded at their grant date fair value and are not subsequently remeasured. Warrants that do not meet this criteria are classified as liabilities and remeasured to their fair value at each reporting period.

Stock-Based Compensation

The Company accounts for all stock-based payment awards granted to employees and nonemployees using a fair value method. The Company’s stock-based payments include stock options and grants of common stock, including common stock subject to vesting. The measurement date for employee awards is the date of grant, and stock-based compensation costs are recognized as expense over the employees’ requisite service period, which is generally the vesting period, on a straight-line basis. The measurement date for nonemployee awards is the date the services are completed, resulting in periodic adjustments to stock-based compensation during the vesting period for changes in the fair value of the awards. Stock-based compensation costs for nonemployees are recognized as expense over the vesting period on a straight-line basis. Stock-based compensation expense is classified in the accompanying consolidated statements of operations and comprehensive loss based on the department to which the related services are provided.

Financial Instruments

The Company’s financial instruments consist of cash equivalents, marketable securities, accounts payable and liability classified warrants. The carrying amounts of cash and cash equivalents and accounts payable approximate their fair value due to the short-term nature of those financial instruments. The fair value of the marketable securities and liability classified warrants are remeasured to fair value each reporting period as described in Note 5.

Fair Value Measurements

The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures (“ASC 820”), establishes a hierarchy of inputs used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability, and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The three levels of the fair value hierarchy are described below:

Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

Level 2—Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant inputs are observable, either directly or indirectly.

Level 3—Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and unobservable.

To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Company’s assets and liabilities measured at fair value on a recurring basis include cash equivalents, marketable securities and warrant liabilities.



Net Loss Per Share

Basic net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock and dilutive common stock equivalents outstanding for the period, determined using the treasury-stock method and the as if-converted method, for convertible securities, if inclusion of these instruments is dilutive. As of September 30, 2017 and December 31, 2016, both methods are equivalent. Common stock, preferred stock and warrant issuances are described further in Note 7.

Income Taxes

Deferred tax assets and liabilities are determined based upon the differences between the financial statement carrying amounts and the tax basis of existing assets and liabilities and for loss and credit carryforwards using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that some portion or all of the deferred tax asset will not be realized.

The Company assesses its income tax positions and records tax benefits based upon management’s evaluation of the facts, circumstances and information available at the reporting date. For those tax positions where it is more likely than not that a tax benefit will be sustained, the Company records the largest amount of tax benefit with a greater than 50% likelihood of being realized upon ultimate settlement with a taxing authority having full knowledge of all relevant information. For those income tax positions where it is not more likely than not that a tax benefit will be sustained, no tax benefit is recognized in the consolidated financial statements. The Company classifies interest and penalties associated with such uncertain tax positions as a component of interest expense. As of September 30, 2017 and December 31, 2016, the Company has not identified any material uncertain tax positions.

Guarantees and Indemnifications

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

The Company leases office space in Hopkinton, Massachusetts and research and development space in Milford, Massachusetts, under non-cancelable operating leases. The Company has standard indemnification arrangements under these leases that require it to indemnify the landlords against liability for injury, loss, accident, or damage from any claims, actions, proceedings, or costs resulting from certain acts, breaches, violations, or nonperformance under the Company’s lease.

Through September 30, 2017, the Company had not experienced any losses related to these indemnification obligations and no material claims were outstanding. The Company does not expect significant claims related to these indemnification obligations, and consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established.

Segment Information

Operating segments are identified as components of an enterprise about which separate and discrete financial information is available for evaluation by the chief operating decision maker, the Company’s chief executive officer, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment and does not track expenses on a program-by-program basis.

Recently Issued Accounting Pronouncements

In November 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash, which includes provisions intended to clarify how entities present restricted cash and restricted cash equivalents in the statement of cash flows. Companies must show the change in total cash, cash equivalents, restricted cash and restricted cash equivalents in the statement of cash flows. The new standard is applied retrospectively and is effective for our annual periods beginning after December 15, 2017, and for interim periods within those annual periods, with early adoption permitted. The Company elected early adoption of this standard as of September 30, 2017, the first period in which the Company had restricted cash.  The adoption of this standard has resulted in the presentation of the change in cash, cash equivalents and restricted cash on the statement of cash flows in the periods presented.



In March 2016, the FASB issued ASU 2016-09, Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”) to require changes to several areas of employee stock-based compensation payment accounting in an effort to simplify stock-based compensation reporting. The update revises requirements in the following areas: minimum statutory withholding, accounting for income taxes, forfeitures, and intrinsic value accounting for private entities. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016, including interim reporting periods within each annual reporting period. The Company adopted this standard on January 1, 2017. The update revises requirements in the following areas:  minimum statutory withholding, accounting for income taxes, and forfeitures. Prior to adoption, the Company applied a 0% forfeiture rate to stock-based compensation, resulting in no cumulative effect adjustment to the opening period. Upon adoption of this standard, the Company’s accounting policy is to recognize forfeitures as they occur.

The update requires the Company to recognize the income tax effect of awards in the income statement when the awards vest or are settled. It also allows the Company to repurchase more of an employee’s shares than it could prior to the update for tax withholding purposes without triggering a liability. The income tax related items had no effect on the current period presentation and the Company maintains a full valuation allowance against its deferred tax assets.

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASC 606”), which amends the guidance for revenue recognition to replace numerous industry-specific requirements. ASC 606 implements a five-step process for customer contract revenue recognition that focuses on transfer of control, as opposed to transfer of risk and rewards. ASC 606 also requires enhanced disclosures regarding the nature, amount, timing, and uncertainty of revenues and cash flows from contracts with customers. Other major provisions include ensuring the time value of money is considered in the transaction price, and allowing estimates of variable consideration to be recognized before contingencies are resolved in certain circumstances. The amendments in ASC 606 are effective for reporting periods beginning after December 15, 2016, and early adoption is not permitted. In July 2015, the FASB approved the deferral of adoption by one year. Entities can transition to the standard either retrospectively or as a cumulative-effect adjustment as of the date of adoption. Until the Company expects material revenue to be recognized, the adoption of this standard is not expected to have an impact on the Company’s consolidated financial statements.

In January 2016, the FASB issued ASU 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities, which amends ASC Subtopic 825-10, Financial Instruments - Overall, and includes updates on certain aspects of recognition, measurement, presentation and disclosure of financial instruments and applies to all entities that hold financial assets or owe financial liabilities. The new standard is effective for the Company for the annual period beginning after December 15, 2017, with early adoption permitted. The Company is currently evaluating the impact that the adoption of this standard may have on its consolidated financial statements.

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which supersedes the current leasing guidance and upon adoption, will require lessees to recognize right-of-use assets and lease liabilities on the balance sheet for all leases with terms longer than 12 months. The new standard is effective for the Company for the annual period beginning after December 15, 2018, and can be early adopted by applying a modified retrospective approach for leases existing at, and entered into after, the beginning of the earliest comparable period presented in the financial statements. The Company is currently evaluating the impact that the adoption of this standard may have on its consolidated financial statements.

In September 2016, the FASB issued ASU 2016-15, Classification of Certain Cash Receipts and Cash Payments, which amends ASC Topic 230, Statement of Cash Flows, and includes provisions intended to reduce diversity in practice and provides guidance on eight specific statements of cash flows classification issues. The new standard is effective for the Company for the annual period ending after December 15, 2017, and for annual and interim periods thereafter, with early adoption permitted. The Company is currently evaluating the impact that the adoption of this standard may have on its consolidated financial statements.

In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815): I. Accounting for Certain Financial Instruments with Down Round Features and II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. Part I applies to entities that issue financial instruments such as warrants, convertible debt or convertible preferred stock that contain down round features. Part II simply replaces the indefinite deferral for certain mandatorily redeemable noncontrolling interests and mandatorily redeemable financial instruments of nonpublic entities contained within Accounting Standards Codification (ASC) Topic 480 with a scope exception and does not impact the accounting for these mandatorily redeemable instruments. This ASU is effective for public companies for the annual reporting periods beginning after December 15, 2018, and interim periods within those annual periods. Early adoption is permitted. The Company is currently evaluating the impact that the adoption of this standard may have on its consolidated financial statements.


2. NET LOSS PER SHARE

The following table summarizes the computation of basic and diluted net loss per share of the Company for such periods (in thousands, except share and per share data):

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Net loss

 

$

(10,828

)

 

$

(4,148

)

 

$

(26,217

)

 

$

(14,966

)

Weighted-average number of common shares-basic and diluted

 

 

12,696,986

 

 

 

7,759,630

 

 

 

10,555,461

 

 

 

6,856,876

 

Net loss per common share-basic and diluted

 

$

(0.85

)

 

$

(0.53

)

 

$

(2.48

)

 

$

(2.18

)

Diluted net loss per common share is the same as basic net loss per common share for all periods presented.

The following potentially dilutive securities outstanding, prior to the use of the treasury stock method or if-converted method, have been excluded from the computation of diluted weighted-average shares outstanding, because such securities had an antidilutive impact due to the losses reported:

 

 

For the Three and Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

Common stock warrants

 

 

1,798,084

 

 

 

153,347

 

Stock options

 

 

977,565

 

 

 

718,065

 

3. INVESTMENTS

Cash in excess of the Company’s immediate requirements is invested in accordance with the Company’s investment policy that primarily seeks to maintain adequate liquidity and preserve capital.

The following table summarizes the Company’s investments, by category, as of September 30, 2017 and December 31, 2016 (in thousands):

 

 

September 30,

 

 

December 31,

 

Investments - Current:

 

2017

 

 

2016

 

Debt securities - available for sale

 

$

34,640

 

 

$

14,046

 

Total

 

$

34,640

 

 

$

14,046

 

 

 

 

 

��

 

 

 

 

Investments - Noncurrent:

 

 

 

 

 

 

 

 

Debt securities - available for sale

 

$

 

 

$

752

 

Total

 

$

 

 

$

752

 


A summary of the Company’s available-for-sale classified investments consisted of the following (in thousands):

 

 

At September 30, 2017

 

 

 

Cost

Basis

 

 

Unrealized

Gains

 

 

Unrealized

Losses

 

 

Fair

Value

 

Investments - Current:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Commercial paper

 

$

14,345

 

 

$

 

 

$

 

 

$

14,345

 

Corporate bonds

 

 

18,309

 

 

 

 

 

 

(7

)

 

 

18,302

 

United States treasury securities

 

 

1,993

 

 

 

 

 

 

 

 

 

1,993

 

Total

 

$

34,647

 

 

$

 

 

$

(7

)

 

$

34,640

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

At December 31, 2016

 

 

 

Cost

Basis

 

 

Unrealized

Gains

 

 

Unrealized

Losses

 

 

Fair

Value

 

Investments - Current:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Agency bonds

 

$

452

 

 

$

 

 

$

 

 

$

452

 

Commercial paper

 

 

2,947

 

 

 

 

 

 

 

 

 

2,947

 

Corporate bonds

 

 

8,499

 

 

 

 

 

 

(7

)

 

 

8,492

 

United States treasury securities

 

 

2,155

 

 

 

 

 

 

 

 

 

2,155

 

Total

 

$

14,053

 

 

$

 

 

$

(7

)

 

$

14,046

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Investments - Noncurrent:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Corporate bonds

 

 

752

 

 

 

 

 

 

 

 

 

752

 

Total

 

$

752

 

 

$

 

 

$

 

 

$

752

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The amortized cost and fair value of the Company’s available-for-sale investments, by contract maturity, as of September 30, 2017 consisted of the following (in thousands):

 

 

Amortized Cost

 

 

Fair Value

 

Due in one year or less

 

$

34,647

 

 

$

34,640

 

Due after one year through two years

 

 

 

 

 

 

Total

 

$

34,647

 

 

$

34,640

 

4. PROPERTY AND EQUIPMENT, NET

Property and equipment as of September 30, 2017 and December 31, 2016 consisted of the following (in thousands):

 

 

September 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

Equipment

 

$

683

 

 

$

576

 

Furniture and fixtures

 

 

144

 

 

 

140

 

Leasehold improvements

 

 

149

 

 

 

133

 

Total property and equipment

 

 

976

 

 

 

849

 

Less: accumulated depreciation and amortization

 

 

(442

)

 

 

(327

)

Property and equipment, net

 

$

534

 

 

$

522

 

Depreciation and amortization expense for the three and nine months ended September 30, 2017 was $39,000 and $115,000, respectively. Depreciation and amortization expense for the three and nine months ended September 30, 2016 was $30,000 and $87,000, respectively.



5. FAIR VALUE MEASUREMENTS

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value are performed in a manner to maximize the use of observable inputs and minimize the use of unobservable inputs.

The Company classified its money market funds within Level 1 because their fair values are based on their quoted market prices. The Company classified its commercial paper and fixed income securities within Level 2 because their fair values are determined using alternative pricing sources or models that utilized market observable inputs.

A summary of the assets and liabilities that are measured at fair value as of September 30, 2017 and December 31, 2016 is as follows (in thousands):

 

 

 

 

 

 

Fair Value Measurement at

September 30, 2017

 

 

 

Carrying

Value

 

 

Quoted Prices in

Active Markets

for Identical

Assets

(Level 1)

 

 

Significant

other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds (1)

 

$

15,164

 

 

$

15,164

 

 

$

 

 

$

 

Fixed income securities

 

 

34,640

 

 

 

 

 

 

34,640

 

 

 

 

Total

 

$

49,804

 

 

$

15,164

 

 

$

34,640

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Warrant liabilities

 

$

17,807

 

 

$

 

 

$

 

 

$

17,807

 

Total

 

$

17,807

 

 

$

 

 

$

 

 

$

17,807

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair Value Measurement at

December 31, 2016

 

Assets:

 

Carrying

Value

 

 

Quoted Prices in

Active Markets

for Identical

Assets

(Level 1)

 

 

Significant

other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

Money market funds (1)

 

$

9,507

 

 

$

9,507

 

 

$

 

 

$

 

Fixed income securities

 

 

14,798

 

 

 

 

 

 

14,798

 

 

 

 

Total

 

$

24,305

 

 

$

9,507

 

 

$

14,798

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Warrant liabilities

 

$

6,333

 

 

$

 

 

$

 

 

$

6,333

 

Total

 

$

6,333

 

 

$

 

 

$

 

 

$

6,333

 

(1)

Money market funds are included within cash and cash equivalents in the accompanying consolidated balance sheets are recognized at fair value.

The following table reflects the change in the Company’s Level 3 liabilities, which consists of the warrants issued in a private placement in November 2016 (see Note 7), for the period ended September 30, 2017 (in thousands):

 

 

November Private

Placement Warrants

 

Balance at December 31, 2015

 

$

 

     Issuance of warrants

 

 

8,275

 

     Change in fair value

 

 

(1,942

)

Balance at December 31, 2016

 

 

6,333

 

     Change in fair value

 

 

11,474

 

Balance at September 30, 2017

 

$

17,807

 


6. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

Accrued expenses as of September 30, 2017 and December 31, 2016 consisted of the following (in thousands):

 

 

September 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

Clinical

 

$

1,159

 

 

$

738

 

Compensation and benefits

 

 

750

 

 

 

901

 

Accounting and legal

 

 

281

 

 

 

279

 

Other

 

 

122

 

 

 

64

 

Total accrued expenses

 

$

2,312

 

 

$

1,982

 

7. STOCKHOLDERS’ EQUITY

Common and Preferred Stock

Effective February 1, 2016, the Company amended and restated its license agreement with BioHEP Technologies Ltd. (“BioHEP”). In connection with the amendment and restatement, the Company issued 125,000 shares of its common stock to BioHEP and granted to BioHEP a warrant to purchase an additional 125,000 shares of its common stock at an exercise price of $16.00 per share, which warrant will expire on August 1, 2018. The fair value of the common stock as of the date of issuance, $2.0 million, was expensed as research and development costs.

In May 2016, the Company issued and sold in its IPO an aggregate of 944,900 shares of its common stock at $12.00 per share, which included 24,900 shares that represented the exercise of an option to purchase additional shares granted to the underwriters in connection with the IPO.  The offering resulted in $8.2 million of net proceeds to the Company, after deducting underwriting discounts and commissions and other offering expenses payable by the Company. Upon the closing of the Company’s IPO, the Company filed an amended and restated certificate of incorporation, which authorized the Company to issue 200,000,000 shares of common stock and 10,000,000 shares of preferred stock. In connection with the closing of the IPO, the Company received approximately $5.3 million in proceeds upon the exercise of previously issued warrants to purchase 641,743 shares of common stock of the Company.

Upon the closing of the Company’s IPO, all outstanding shares of the Company’s preferred stock automatically converted into 250,000 shares of the Company’s common stock.

In November 2016, the Company entered into a definitive agreement with respect to the private placement of 1,644,737 shares of common stock and warrants to purchase 1,644,737 shares of common stock (the “November Private Placement Warrants”) to a group of accredited investors (the “November Private Placement”). These investors paid $9.12 for each share of common stock and warrant to purchase one share of common stock. The November Private Placement Warrants are exercisable at an exercise price of $10.79 per share and expire on November 23, 2021. The Company completed the November Private Placement on November 23, 2016, resulting in $13.7 million in net proceeds to the Company, after deducting placement agent fees and other offering expenses payable by the Company.

In June 2017, the Company issued and sold in an underwritten public offering an aggregate of 3,269,219 shares of its common stock at $13.00 per share, which included 384,604 shares pursuant to the exercise of an option to purchase additional shares granted to the underwriters in connection with the offering. The offering resulted in $39.6 million of net proceeds to the Company, after deducting underwriting discounts and commissions and other offering expenses payable by the Company.

In August 2017, the Company entered into a Controlled Equity OfferingSales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), pursuant to which the Company may offer and sell, from time to time through Cantor, shares of the Company’s common stock having an aggregate offering price of up to $50.0 million. The Company will pay Cantor a commission rate equal to 3.0% of the aggregate gross proceeds from each sale.

Warrants

In connection with the amendment and restatement of a license agreement with BioHEP, the Company issued a warrant to purchase 125,000 shares of the Company’s common stock to BioHEP (the “BioHEP Warrant”), effective February 1, 2016. The Company evaluated the terms of the warrant and concluded that it should be equity-classified. The fair value of the warrant, $0.8 million, was estimated on the issuance date using a Black Scholes pricing model based on the following assumptions: an expected term of two and a half years, expected stock price volatility of 71%, a risk free rate of 1.01%, and a dividend yield of 0%. The fair value was expensed as research and development costs.


In connection with the Company’s IPO, the Company issued to the sole book-running manager for the IPO a warrant to purchase 27,600 shares of common stock in May 2016 and a warrant to purchase 747 shares of common stock in June 2016 (together, the “IPO Warrants”). The IPO Warrants are exercisable at an exercise price of $15.00 per share and expire on May 5, 2021. The Company evaluated the terms of the IPO Warrants and concluded that they should be equity-classified. The fair value of the May 2016 IPO Warrants was estimated on the applicable issuance dates using a Black Scholes pricing model based on the following assumptions: an expected term of 4.99 years; expected stock price volatility of 87%; a risk free rate of 1.20%; and a dividend yield of 0%. The fair value of the June 2016 IPO Warrants was estimated on the applicable issuance dates using a Black Scholes pricing model based on the following assumptions: an expected term of 4.92 years; expected stock price volatility of 87%; a risk free rate of 1.23%; and a dividend yield of 0%. The aggregate fair value of the IPO Warrants was $0.2 million.

The Company received approximately $5.3 million in proceeds upon the exercise of warrants to purchase 641,743 shares of its common stock of the Company, which were exercised in connection with the closing of the IPO. Upon the closing of the Company’s IPO, all of the outstanding warrants that were not exercised, except the BioHEP warrant and the IPO Warrants, terminated in accordance with their original terms.

In connection with the November Private Placement, the Company issued the November Private Placement Warrants to purchase 1,644,737 shares of common stock in November 2016 to a group of accredited investors. The November Private Placement Warrants are exercisable at an exercise price of $10.79 per share and expire on November 23, 2021. The Company evaluated the terms of these warrants and concluded that they are liability-classified. In November 2016, the Company recorded the fair value of these warrants of approximately $8.3 million using a Black Scholes pricing model. The Company must recognize any change in the value of the warrant liability each reporting period in the statement of operations. As of December 31, 2016 and September 30, 2017, the fair value of the November Private Placement Warrants was approximately $6.3 million and $17.8 million, respectively (see Note 5).

A summary of the Black Scholes pricing model assumptions used to record the fair value of the warrants is as follows:

 

 

September 30, 2017

 

 

December 31, 2016

 

Risk-free interest rate

 

 

1.8

%

 

 

1.9

%

Expected term (in years)

 

 

4.1

 

 

 

4.9

 

Expected volatility

 

 

70.0

%

 

 

65.5

%

Expected dividend yield

 

 

0

%

 

 

0

%

The following table summarizes the warrant activity for the year ended December 31, 2016 and for the nine months ended September 30, 2017:

Warrants

Outstanding at December 31, 2015

1,181,776

     Grants

1,798,084

     Exercises

(641,743

)

     Expirations/cancellations

(540,033

)

Outstanding at December 31, 2016

1,798,084

     Grants

     Exercises

     Expirations/cancellations

Outstanding at September 30, 2017

1,798,084

2014 Stock Incentive Plan

In April 2014, the Company’s Board of Directors approved the 2014 Stock Incentive Plan (the “2014 Plan”). The Company’s 2014 Plan provides for the issuance of common stock, stock options and other stock-based awards to employees, officers, directors, consultants, and advisors. As of September 30, 2017, the Board had authorized 750,000 shares of common stock to be issued under the 2014 Plan. The Company’s 2015 Stock Incentive Plan (the “2015 Plan”) became effective immediately prior to the closing of the Company’s IPO on May 11, 2016. Upon the effectiveness of the 2015 Plan, 116,863 shares of common stock that remained available for grant under the 2014 Plan became available for grant under the 2015 Plan, and no further awards were available to be issued under the 2014 Plan.


2015 Stock Incentive Plan

The 2015 Plan provides for the issuance of common stock, stock options and other stock-based awards to employees, officers, directors, consultants and advisors of the Company. The number of shares reserved for issuance under the 2015 Plan is the sum of 750,000 shares of common stock, plus the number of shares equal to the sum of (i) 116,863 shares of common stock, which was the number of shares reserved for issuance under the 2014 Plan that remained available for grant under the 2014 Plan immediately prior to the closing of the Company’s IPO, and (ii) the number of shares of common stock subject to outstanding awards under the 2014 Plan that expire, terminate or are otherwise surrendered, cancelled or forfeited. The exercise price of stock options cannot be less than the fair value of the common stock on the date of grant. Stock options awarded under the 2015 Plan expire 10 years after the grant date, unless the Board sets a shorter term. As of September 30, 2017, the Company had 472,087 shares available for issuance under the 2015 Plan.

The following table summarizes the option activity for the nine months ended September 30, 2017, under the 2014 Plan and the 2015 Plan (collectively the “Plans”):

 

 

Options

 

 

Weighted-Average

Exercise Price

Per Share

 

 

Aggregate

Intrinsic

Value

 

Options outstanding at December 31, 2015

 

 

610,481

 

 

$

11.99

 

 

$

 

     Granted

 

 

128,334

 

 

 

10.41

 

 

 

 

     Exercised

 

 

(10,247

)

 

 

9.28

 

 

 

29,550

 

     Cancelled

 

 

(24,253

)

 

 

9.89

 

 

 

 

Outstanding at December 31, 2016

 

 

704,315

 

 

$

11.82

 

 

 

 

     Granted

 

 

286,500

 

 

 

8.20

 

 

 

 

     Exercised

 

 

(10,000

)

 

 

9.28

 

 

 

11,228

 

     Cancelled

 

 

(3,250

)

 

 

12.44

 

 

 

 

Options outstanding at September 30, 2017

 

 

977,565

 

 

$

10.78

 

 

$

5,923,320

 

Options exercisable at September 30, 2017

 

 

390,417

 

 

$

11.67

 

 

$

2,019,924

 

As of September 30, 2017, all options granted are expected to vest and the weighted-average remaining contractual life of all options is 8.4 years. The weighted-average fair value of all stock options granted for the nine months ended September 30, 2017 was $5.67.  Intrinsic value at September 30, 2017 is based on the closing price of the Company’s common stock of $16.84 per share.

Prior to the Company’s IPO on May 11, 2016, the Board determined the estimated fair value of the Company’s common stock on the date of grant based on a number of objective and subjective factors, including third party valuations. Since the IPO, the fair value of the Company’s common stock on the date of the grant is based on the closing price per share of the common stock on the NASDAQ Capital Market on the date of grant. The computation of expected volatility is based on the historical volatilities of peer companies. The peer companies include organizations that are in the same industry, with similar size and stage of growth. The Company estimates that the expected life of the options granted using the simplified method allowable under the SEC’s Staff Accounting Bulletin No. 107, Share Based Payments. The interest rate is based on the U.S. Treasury bill rates for U.S. treasury bills with terms commensurate with the expected term of the option grants on the grant date of the option. The Company accounts for stock option forfeitures when they occur.

There were no stock options granted prior to 2015. The assumptions the Company used to determine the fair value of stock options granted to employees and directors in 2017 and 2016 are as follows, presented on a weighted-average basis.

 

 

Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

Risk-free interest rate

 

 

2.0

%

 

 

1.4

%

Expected term (in years)

 

 

6.0

 

 

 

6.1

 

Expected volatility

 

 

79.8

%

 

 

77.6

%

Expected dividend yield

 

 

0

%

 

 

0

%


The following table summarizes the stock-based compensation expense for the three and nine months ended September 30, 2017 and 2016, under the Plans (in thousands):

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Stock-based compensation:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

121

 

 

$

104

 

 

$

402

 

 

$

286

 

General and administrative

 

 

389

 

 

 

274

 

 

 

1,081

 

 

 

729

 

Total Stock-based compensation

 

$

510

 

 

$

378

 

 

$

1,483

 

 

$

1,015

 

The fair value of stock options vested during the nine months ended September 30, 2017 was $1,275,000. At September 30, 2017, there was $3,875,000 of unrecognized stock-based compensation expense relating to stock options granted pursuant to the Plans, which will be recognized over the weighted-average remaining vesting period of 2.3 years.

Reserved Shares

As of September 30, 2017 and 2016, the Company has reserved the following shares of common stock for potential conversion of the exercise of warrants and outstanding options and issuance of shares available for grant under the 2015 Plan:

 

 

September 30,

 

 

 

2017

 

 

2016

 

2016 BioHEP warrants

 

 

125,000

 

 

 

125,000

 

2016 IPO warrants

 

 

28,347

 

 

 

28,347

 

November Private Placement warrants

 

 

1,644,737

 

 

 

 

2014 and 2015 Stock incentive plans

 

 

1,449,652

 

 

 

1,475,000

 

Total

 

 

3,247,736

 

 

 

1,628,347

 

8. COMMITMENTS AND CONTINGENCIES

Leases

In April 2015, the Company entered into an amendment to the lease for its research and development facility in Milford, Massachusetts to extend the term of the lease through March 31, 2018 and expand the leased laboratory space.

In March 2016, the Company entered into a new operating lease for its headquarters in Hopkinton, Massachusetts with a lease term through May 31, 2021. The total payments due during the term of the lease are approximately $771,000.

Rent paid for the three and nine months ended September 30, 2017 was $59,000 and $174,000, respectively. Rent paid for the three and nine months ended September 30, 2016 was $56,000 and $110,000, respectively.

Future minimum commitments due under all leases at September 30, 2017 are as follows (in thousands):

Year

 

 

 

 

2017

 

$

59

 

2018

 

 

174

 

2019

 

 

157

 

2020

 

 

164

 

Thereafter

 

 

70

 

Total minimum lease payments

 

$

624

 

See subsequent events (Note 10) regarding a new lease commitment that the Company entered into after September 30, 2017. The commitments under the new lease agreement are not included in the table above.



BioHEP Technologies Ltd. License Agreement

In January 2016, the Company entered into an amended and restated license agreement with BioHEP, which became effective on February 1, 2016.

Under the amended and restated license agreement, the Company agreed to pay BioHEP up to $3.5 million in development and regulatory milestone payments for disease(s) caused by each distinct virus for which the Company develops licensed product(s). BioHEP is also eligible to receive tiered royalties in the low-to-mid single-digits on net product sales of licensed products by the Company and its affiliates and sub licensees, and a specified share of non-royalty sublicensing revenues the Company and its affiliates receive from sub licensees, which share of sublicensing revenues is capped at a maximum aggregate of $2.0 million under all such sublicenses.

Contingencies

The Company accrues for contingent liabilities to the extent that the liability is probable and estimable.  There are no accruals for contingent liabilities in these consolidated financial statements.

During May 2015, the Company entered into a transition agreement with the Company’s former President and Chief Executive Officer. Under the transition agreement, he continued to serve as the Company’s president and chief executive officer for a transition period that ended on August 17, 2015. Following the transition period, the Company made 18 monthly payments totaling $464,000 and also provided benefits consistent with the coverage that was provided prior to the execution of the transition agreement. There was no remaining unpaid balance relating to this obligation at September 30, 2017.

9. RELATED PARTY TRANSACTIONS

During the nine months ended September 30, 2016, the Company reimbursed BioHEP, a greater than five percent stockholder as of September 30, 2016, $14,000 for legal expenses that BioHEP incurred in connection with entering into the amended and restated license agreement. The Company incurred no such payments during the nine months ended September 30, 2017.

10. SUBSEQUENT EVENTS

The Company has evaluated subsequent events through the date on which the consolidated financial statements were issued, to ensure that this submission includes appropriate disclosure of events both recognized in the consolidated financial statements and events which occurred subsequently but were not recognized in the consolidated financial statements.

On October 4, 2017, the Company entered into a lease agreement (the “New Lease”) in Hopkinton, Massachusetts.  The premises covered by the New Lease will serve as the Company’s new principal office and laboratory space.  The initial term of the New Lease is 125 months beginning on the date on which the landlord substantially completes certain renovations to the premises covered by the New Lease.  The Company has the option to extend the New Lease one time for an additional 5-year period.  Following an eleven-month rent abatement period, the Company will be obligated to make monthly rent payments in the amount of $34,533, which is subject to increase by approximately 3% annually for the first five years of the New Lease and by approximately 2.5% annually thereafter. The total lease payments due during the term of the lease are approximately $4.4 million. In addition, the Company is responsible under the New Lease for specified costs and charges, including certain operating expenses, utilities, taxes and insurance.   


Item 2.

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

You should read the following discussion and analysis of financial condition and results of operations together with Part I, Item 1“Financial Statements” and related notes included elsewhere in this Quarterly Report on Form 10-Q.

Overview

We are a clinical-stage biopharmaceutical company engaged in the discovery and development of a novel class of therapeutics using our proprietary small molecule nucleic acid hybrid, or SMNH, chemistry platform. Our SMNH compounds are small segments of nucleic acids that we design to selectively target and modulate the activity of specific proteins implicated in various disease states. We are developing our most advanced SMNH product candidate, inarigivir soproxil (formerly known as SB 9200), which we refer to as inarigivir, for the treatment of certain viral diseases. We have designed inarigivir to selectively activate within infected cells the cellular proteins, retinoic acid-inducible gene 1 (RIG-I) and nucleotide-binding oligomerization domain-containing protein 2 (NOD2), to inhibit viral replication and to cause the induction of intracellular interferon signaling pathways for antiviral defense. We believe that inarigivir may play an important role in antiviral therapy by modulating the body’s immune response through its mechanisms of action to fight viral infections. We are also developing other SMNH product candidates, including SB 11285, an immunotherapeutic agent for the treatment of selected cancers through the activation of the STimulator of INterferon Genes, or STING, pathway.

RIG-I Product Candidates

We are currently developing inarigivir for the treatment of chronic hepatitis B virus, or HBV. We are conducting Part A of our Phase 2 ACHIEVE multi-center clinical trial of inarigivir in Canada, Hong Kong, Korea and Taiwan. Part A of the Phase 2 ACHIEVE trial is a randomized, placebo-controlled, multiple ascending dose trial in up to 80 non-cirrhotic patients infected with chronic HBV using doses of 25 mg, 50 mg, 100 mg and 200 mg of inarigivir as a monotherapy administered daily for 12 weeks. Following this treatment, all patients will receive treatment with the oral antiviral agent tenofovir disoproxil fumarate (marketed by Gilead Sciences, Inc., or Gilead, as Viread®), which we refer to as Viread, as a monotherapy for 12 weeks. Patients will be sequentially enrolled into one of the four dose cohorts and randomized between the inarigivir dose group or placebo on a 4:1 basis. Patients are stratified based on HBeAg positive (+) or negative (–) status. HBeAg is a non-structural protein which is secreted by the virus and whose presence in blood, or HBeAg–positive, is indicative of wild type or non-mutated virus with high levels of viral replication. The loss of HBeAg occurs secondary to mutations in the virus and results in a patient becoming HBeAg negative with a resulting lower level of actively replicating virus. The primary endpoints of Part A of the Phase 2 ACHIEVE clinical trial are safety and antiviral activity, as measured by the change in HBV DNA at week 12 from baseline. Multiple exploratory secondary endpoints include reduction or loss of hepatitis B surface antigen, or HBsAg, and HBeAg, quantitative HBV RNA as a marker for control of virus production and studies of immune activity.

In May 2017, we reported top-line results from the first inarigivir monotherapy dosing cohort of Part A of the Phase 2 ACHIEVE clinical trial indicating that a low dose (25mg) of inarigivir alone showed a favorable safety profile and antiviral activity against HBV DNA and HBsAg. The first inarigivir monotherapy dosing cohort consisted of 11 HBeAg-positive and 9 HBeAg–negative patients, of which 80% were genotype B/C, the most common Asian genotypes. Administration of inarigivir resulted in a statistically significant reduction in HBV DNA at week 12 (unpaired t-test 2.85, p=0.01) compared to placebo, with a mean reduction of 0.6 log10 (range 0 to 1.87 log10) in the inarigivir treatment group. For the secondary endpoint of reduction or loss of HBsAg, 5 of 16 patients (31%) in the inarigivir treatment group had a greater than 0.5 log10 reduction at any time point (range 0.52 to 1.01 log10), compared to none in the placebo group. The 7 HBeAg–negative patients in the inarigivir treatment group had the greatest mean reduction in HBV DNA at 0.9 log10, and 3 of these 7 patients also had a greater than 0.5 log10 reduction in HBsAg. The overall safety profile of inarigivir was favorable with no serious adverse events observed during the 12 week study. Treatment-emergent adverse events ranged from mild to moderate in severity with no interferon-like side effects and were comparable to patients on placebo.

In October 2017, we reported additional results from the first cohort of Part A of the Phase 2 ACHIEVE clinical trial consisting of patient data from 12 weeks of Viread monotherapy treatment that followed 12 weeks of inarigivir (25mg) monotherapy treatment.  Treatment with Viread monotherapy during weeks 12-24 of the first cohort induced potent suppression of HBV DNA in all patients including placebo, and 6 of 16 patients (38%) in the inarigivir treatment group had a greater than 0.5 log10 reduction in HBsAg at week 24, which included 3 HBeAg-positive patients.  An associated greater than 0.75 log10 reduction in HBeAg was seen in 4 of 9 (44%) HBeAg-positive patients in the inarigivir treatment group, compared to zero of four (0%) in the placebo group. We believe this data suggests an enhanced effect of Viread in the inarigivir treated patients and is supportive of the proposed combination strategy that will be evaluated in Part B of the Phase 2 ACHIEVE trial, as discussed below.  


We expect to report top-line results from the second inarigivir monotherapy dosing cohort (50mg) of Part A of the Phase 2 ACHIEVE clinical trial in the fourth quarter of 2017, and to report top-line monotherapy results for all patients treated with inarigivir alone in the second half of 2018.

Part B of the Phase 2 ACHIEVE clinical trial, which we expect to initiate in the second half of 2018, will consist of 12 weeks of combination treatment with inarigivir (100mg) and Viread. Following this treatment, all patients will receive treatment with Viread as a monotherapy for 12 weeks. We expect to initiate Part B of this clinical trial in the second half of 2018. Both Parts A and B of the Phase 2 ACHIEVE clinical trial are being conducted under our clinical trial supply and collaboration agreement with Gilead.

We have entered into multiple collaborations and seek to enter into additional collaborations with third parties that are investigating and/or developing compounds for the treatment of chronic HBV with different pharmacological mechanisms of action than inarigivir. Pursuant to this strategy, in 2016, we entered into an agreement with Arrowhead Pharmaceuticals, Inc., or Arrowhead, to collaborate on the study of the combined use of inarigivir and Arrowhead’s small interfering ribonucleic acid, or siRNA, product pipeline for the treatment of chronic HBV. Under this collaboration with Arrowhead, we agreed first to study the co-administration of both agents in preclinical models, with the potential to be added to a clinical study.  We have also entered into a material transfer agreement with a third party to conduct preclinical experiments examining the co-administration of inarigivir with a capsid inhibitor for the potential treatment of patients infected with chronic HBV. Additionally, in July 2017, we entered into a clinical trial collaboration with Gilead under which Gilead will fund and conduct a Phase 2 trial examining the co-administration of inarigivir and tenofovir alafenamide (marketed by Gilead as Vemlidy®) in patients infected with chronic HBV.  The protocol for this Phase 2 clinical trial provides that treatment will consist of 12 weeks of combination therapy with inarigivir (50mg) and Vemlidy. Following this treatment, all patients will receive treatment with Vemlidy as a monotherapy for 12 weeks. We anticipate that Gilead will initiate this clinical trial in the first quarter of 2018.  

We are also pursuing the development of the co-formulation of inarigivir with Viread and with entecavir (marketed as Baraclude®), which we refer to as Baraclude, as potential fixed-dose combination products for the treatment of patients with chronic HBV who may benefit from the combined use of inarigivir as a potential immunomodulatory agent, and Baraclude or Viread, as the antiviral agent. We anticipate that the fixed-dose combination product(s) could result in enhanced patient compliance and potentially allow for a more favorable safety profile. We have conducted early development work on a co-formulation of inarigivir with Viread and believe that inarigivir with Viread is compatible in the same formulation. We believe that the immunomodulatory activity provided by inarigivir could become a key component of a future combinatorial treatment of patients infected with chronic HBV, which could increase the percentage of chronic HBV patients who achieve a functional cure. 

STING Agonist Product Candidates

We are developing SB 11285, a novel proprietary STING agonist, as a potential immunotherapeutic agent for the treatment of selected cancers. Recent published scientific literature indicates that the activation of the STING pathway can result in the induction of cellular interferons and cytokines and promote an aggressive and strong anti-tumor response through the induction of innate and adaptive immune response. In our preclinical studies performed in in vitro systems, SB 11285 has been observed to cause the induction of interferon and other cytokines, as well as cell death, or apoptosis, of multiple tumor-derived cell lines.

We continue to conduct preclinical studies of SB 11285 in multiple in vivo cancer models. In 2017, we have presented data from in vivo studies in the A20 lymphoma, CT26 colon carcinoma, B16 melanoma and orthotopic4T1 breast cancer syngeneic mouse models at various industry conferences, including the March 2017 Cancer Immunology and Immunotherapy Keystone Symposia, the June 2017 American Society of Clinical Oncology (ASCO) Annual Meeting and the October 2017 American Association for Cancer Research (AACR) Conference on Tumor Immunology and Immunotherapy.SB 11285 was evaluated for tumor growth inhibition and tumor growth delay and has shown that it is highly potent and has a durable anti-tumor response when administered intravenously, intratumorally and intraperitoneally across different tumor models. The induction of immune-memory, tumor growth inhibition and abscopal anti-tumor activity upon intra-tumoral administration of SB 11285 has been observed in the A20 lymphoma model. In addition, in the CT26 colon cancer syngeneic mouse model, SB 11285 has exhibited dose-dependent, potent tumor growth inhibition and durable anti-tumor response upon intra-tumoral, intraperitoneal and intravenous routes of administration. In the B16 melanoma model, intravenous and intraperitoneal administration of SB 11285 showed significant inhibition of tumor growth.   In the orthotopic 4T1 breast cancer model, intraperitoneal administration of SB 11285 resulted in significant inhibition of primary tumor growth, as well as inhibition of tumor metastasis. In the rat orthotopic bladder cancer model, intravenous administration of SB 11285 resulted in potent, dose-dependent inhibition of tumor growth in bladder.  As part of the mechanism of action, immuno-histochemistry combined with flow cytometric analysis of tissues and blood from SB 11285-treated groups were conducted which revealed the presence of activated immune cells, including CD8+ T cells, natural killer (NK) cells and macrophages critical for anti-tumor activity. We believe these preclinical studies demonstrate the potential for both intra-tumoral and systemic administration of SB 11285 to target a variety of tumors, which could potentially be used in combination with other therapeutic modalities.



We intend to continue the development of SB 11285 as a potentially important addition to the current standard of care in the treatment of various cancers that we believe could increase the treatment responses in patients. We intend to continue to advance the SB 11285 program with preclinical, toxicology, and process development efforts. Subject to the results of these preclinical studies, we hope to submit an investigational new drug application, or IND, and/or a clinical trial application, or CTA, for SB 11285 in mid-2018, and, if cleared, commence Phase Ib/II clinical trials in liver cancer in the second half of 2018.

In August 2017, we entered into a preclinical research collaboration with a third party to examine the potential for the conjugation of selected compounds from our STING agonist platform with selected proprietary antibodies from the third-party’s immune-oncology portfolio.

Recent Developments

On October 4, 2017, we entered into a lease agreement, or the New Lease, in Hopkinton, Massachusetts.  The premises covered by the New Lease will serve as our new principal office and laboratory space.  The initial term of the New Lease is 125 months beginning on the date on which the landlord substantially completes certain renovations to the premises covered by the New Lease.  We have the option to extend the New Lease one time for an additional 5-year period. The total lease payments due during the term of the lease are approximately $4.4 million.

Financial Operations Overview

To date, we have devoted substantially all of our resources to research and development efforts, including conducting clinical trials for our product candidates, protecting our intellectual property and providing general and administrative support for these operations. We have not generated any revenue to date other than from grants from the National Institutes of Health, or NIH. We have incurred significant annual net operating losses in every year since our inception and expect to continue to incur significant expenses and net operating losses for the foreseeable future. Our net losses were $10.8 million and $26.2 million for the three and nine months ended September 30, 2017, respectively, and $17.4 million for the year ended December 31, 2016. As of September 30, 2017, we had an accumulated deficit of $77.8 million. Our net losses may fluctuate significantly from quarter to quarter and year to year. We expect to continue to incur significant expenses and increasing operating losses for the next several years.  We anticipate that our expenses will increase significantly as we continue to develop inarigivir, SB 11285 and our other product candidates.  See “—Liquidity and Capital Resources—Funding Requirements.” As a result, we will need additional financing to support our continuing operations. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity or debt financings or other sources, which may include collaborations with third parties. Arrangements with collaborators or others may require us to relinquish rights to certain of our technologies or product candidates. Adequate additional financing may not be available to us on acceptable terms, or at all. Our inability to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenue to achieve and sustain profitability, and we may never be able to do so.

As of September 30, 2017, we had $52.2 million in cash, cash equivalents and marketable securities. We expect that our cash, cash equivalents and marketable securities as of September 30, 2017 will enable us to fund our operating expenses and capital expenditure requirements through the end of 2019.  However, we anticipate that our existing cash, cash equivalents, restricted cash and marketable securities will not be sufficient to fund additional development of inarigivir beyond our Phase 2 ACHIEVE clinical trial. See “—Liquidity and Capital Resources.”

Grant revenue

Historically, we have generated revenue from grants from the NIH for the development of inarigivir. The NIH grants provided funding of $6.8 million between October 2003 and April 2016. As of September 30, 2017, no additional funding remains available to us under any grant for the development of any of our product candidates.

Operating expenses

Our operating expenses since inception have consisted primarily of research and development expense and general and administrative costs.


Research and development

Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts, and the development of our product candidates, which include:

expenses incurred under agreements with third parties, including contract research organizations, or CROs, that conduct research, preclinical activities and clinical trials on our behalf as well as contract manufacturing organizations, or CMOs, that manufacture drug products for use in our preclinical and clinical trials;

salaries, benefits and other related costs, including stock-based compensation expense, for personnel in our research and development functions;

costs of outside consultants, including their fees, stock-based compensation and related travel expenses;

the cost of laboratory supplies and acquiring, developing and manufacturing preclinical study and clinical trial materials;

costs related to compliance with regulatory requirements; and

facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.

We expense research and development costs as incurred. We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors and our clinical investigative sites. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our consolidated financial statements as prepaid or accrued research and development expenses.

Our primary focus of research and development since inception has been on the development of inarigivir. Our direct research and development expenses consist primarily of external costs, such as fees paid to investigators, consultants and CROs in connection with our preclinical studies and clinical trial and regulatory fees. We do not allocate employee-related costs and other indirect costs to specific research and development programs because our primary focus has been on the discovery and development of inarigivir. Our direct research and development expenses are not currently tracked on a program-by-program basis.

The successful development of our product candidates is highly uncertain. Accordingly, at this time, we cannot reasonably estimate the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of these product candidates. We are also unable to predict when, if ever, we will generate revenues from inarigivir or any of our other current or potential product candidates. This is due to the numerous risks and uncertainties associated with developing medicines, including the uncertainties of:

establishing an appropriate safety profile with IND-enabling toxicology studies;

successful enrollment in and completion of clinical trials;

receipt of marketing approvals from applicable regulatory authorities;

establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;

obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates;

launching commercial sales of the products, if and when approved, whether alone or in collaboration with others; and

a continued acceptable safety profile of the products following approval.

A change in the outcome of any of these variables with respect to any of our product candidates would significantly change the costs and timing associated with the development of that product candidate.


Research and development activities are central to the our business model.models. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stagelater stage clinical trials. WeAs a result, we expect that our research and development expenses will continue to increase inover the foreseeable futurenext several years as we continueincrease personnel costs, initiate and conduct additional clinical trials and prepare regulatory filings related to the various product candidates.

The successful development of our product candidates. However, we do not believe that itcandidates is possiblehighly uncertain. As such, at this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to accurately project total program-specific expenses through commercialization. Therecomplete the remainder of the development of these product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from our product candidates. This is due to the numerous factorsrisks and uncertainties associated with developing products, including the successful commercialization of anyuncertainty of:

research and development support of our product candidates, including conducting future trial designclinical trials of FS118, FS120, FS222 and variousSB 11285;
progressing the clinical development of FS118, FS120, FS222 and SB11285;
establishing an appropriate safety profile with investigational new drug-enabling studies to advance our programs into clinical development;
identifying new product candidates to add to our development pipeline;
successful enrollment in, and the initiation and completion of clinical trials;
the timing, receipt and terms of any marketing approvals from applicable regulatory requirements, manyauthorities;
commercializing the product candidates, if and when approved, whether alone or in collaboration with others;
establishing commercial manufacturing capabilities or making arrangements with third party manufacturers;
the development and timely delivery of which cannotcommercial-grade drug formulations that can be determined with accuracy at this time based on our stage of development. Additionally, future commercial and regulatory factors beyond our control will impactused in our clinical trials;
addressing any competing technological and market developments, as well as any changes in governmental regulations;

29


negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter and performing our obligations under such arrangements;
maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how, as well as obtaining and maintaining regulatory exclusivity for our product candidates;
continued acceptable safety profile of the drugs following approval; and
attracting, hiring, and retaining appropriately qualified personnel.

A change in the outcome of any of these variables with respect to the development programsof a product candidate could mean a significant change in the costs and plans.timing associated with the development of that product candidate. For example, the U.S. Food and Drug Administration, European Medicines Agency or another regulatory authority may require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a product candidate, or we may experience significant trial delays due to patient enrolment or other reasons, in which case we would be required to expend significant additional financial resources and time on the completion of clinical development. In addition, we may obtain unexpected results from our clinical trials, and we may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. Identifying potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success.

General and administrative expenses

General and administrative expenses consist primarily of salaries, related benefits, travel, and other related costs, including stock-basedshare-based compensation expense for personnel in our executive, finance, corporate and business developmentlegal and administrative functions. General and administrative expenses also include legal fees relating tofacility-related costs, patent filing and corporate matters;prosecution costs, insurance and marketing costs and professional fees for legal, consulting, accounting, auditing,audit, tax services and consulting services; insurance costs; travel expenses; and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.

We anticipateassociated with being a public company. Other expense also includes foreign currency transaction losses. The Company expects that our general and administrative expenses will increase in the future as we increase our headcount to support the expected growth in our research and developmentCompany expands its operating activities and the potential commercialization of our product candidates. We also expect to continuecontinues to incur significant expenses associated withcosts of being a US public company, including increased costs of accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance costs, and investor and public relations costs.company.

Other income (expense)and expenses, net

Other income (expense) consistsand expenses, net, is primarily rent received from subletting an office in the United States and interest received on overdue trade receivable balances, bank interest received, and interest expense, which is primarily bank interest payable and similar charges, the interest liability on leased assets and convertible debt notes, and foreign exchange losses incurred. Foreign exchange gain (loss) is foreign exchange gains or losses due to the fluctuation of interest income earned on our cash, cash equivalents, restricted cash and marketable securitiesGBP, U.S. dollar and the gain/loss on the changeEuro. Change in the fair value of convertible debt is the warrant liabilities.fair value adjustment of the convertible notes as measured using level 3 inputs.

Critical Accounting Policies and Significant Judgments and EstimatesIncome tax

Our consolidated financial statements are prepared in accordance with generally accepted accounting principlesThe Company is subject to corporate taxation in the United States and the UK.

Our UK established entities have generated losses and some profits in the UK since inception and have therefore not paid significant UK corporation tax. Our Austrian subsidiary has historical losses in Austria with more recent profits, which has resulted in payment of America.Austrian corporation tax in the years ended December 31, 2021, and 2020. The preparationcorporation tax benefit (tax) presented in the Company’s statements of our consolidated financial statementscomprehensive income (loss) represents the tax impact from its operating activities in the United States, UK and related disclosures requires usAustria, which have generated taxable income in certain periods. As the entities located in the UK carry out extensive research and development activities, they seek to benefit from the UK research and development tax credit cash rebate regime known as the Small and Medium-sized Enterprises R&D Tax Credit Program (the “SME Program”). Qualifying expenditures largely comprise employment costs for research staff, consumables expenses incurred under agreements with third parties

30


that conduct research and development, preclinical activities, clinical activities and manufacturing on the Company’s behalf and certain internal overhead costs incurred as part of research projects.

The tax credit received in the UK pursuant to the SME Program permits companies to deduct an extra 130% of their qualifying costs from their yearly profit or loss, as well as the normal 100% deduction, to make estimatesa total 230% deduction. If the company is incurring losses, it is entitled to claim a tax credit worth up to 14.5% of the surrenderable loss. To qualify for relief under the SME Program, companies are required to employ fewer than 500 staff and assumptions that affect the reported amounthave a turnover of assets, liabilities, revenue, costsunder €100.0 million or a balance sheet total of less than €86.0 million.

Research and expenses and related disclosures. We believe that the estimates and assumptions involveddevelopment tax credits received in the accounting policies described therein may haveUK are recorded as a reduction in research and development expenses. The UK research and development tax credit is payable to companies after surrendering tax losses and is not dependent on current or future taxable income. As a result, it is not reflected as part of the greatest potential impact on our consolidated financial statements and, therefore, consider these to be our critical accounting policies. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions and conditions.income tax provision.

Income tax expense was not material for the three months ended March 31, 2022.

Accrued Research and Development Expenses

As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated costs incurred for the services when we have not yet been invoiced or otherwise notified of the actual costs. The majority of our service providers invoice us in arrears for services performed, on a predetermined schedule or when contractual milestones are met; however, some require advanced payments. We make estimates of our accrued expenses as of each balance sheet date in our consolidated financial statements based on facts and circumstances known to us at that time. Examples of estimated accrued research and development expenses include fees paid to:

CROs in connection with performing research services on our behalf and clinical trials;

investigative sites or other providers in connection with clinical trials;

vendors in connection with preclinical and clinical development activities; and

vendors related to product manufacturing, development and distribution of preclinical and clinical supplies.

supplies and material.

We base our expenses related to preclinical studies and clinical trials on our estimates of the services received and efforts expended pursuant to quotes and contracts with multiple CROs that conduct and manage clinical trials on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, we estimate the time period over which services will be performed, enrollment of patients, number of sites activated and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or amount of prepaid expense accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in us reporting amounts that are too high or too low in any particular period. To date, we have not made any material adjustments to our prior estimates of accrued research and development expenses.

Equity-Classified WarrantsContingent value rights

In connection with entering into the amended and restated license agreement with BioHEP effective February 1, 2016, we issued to BioHEP a warrant to purchase 125,000 shares of our common stock at a purchase price of $16.00 per share. We evaluated the termsThe acquisition-date fair value of the warrant and concludedCVR liability represents the future payments that it should be equity-classified.are contingent upon the achievement of sale or licensing for the STING product candidates. The fair value of the warrant, $0.8 millioncontingent value rights is based on the Company’s probability-weighted discounted cash flow assessment that considers probability and was expensed as research and development costs.

In connection with our initial public offering, or IPO, we issued the sole book-running manager for the IPO warrants to purchase 28,347 sharestiming of common stock at an exercise price of $15.00 per share, which we refer to collectively as the IPO warrants. We evaluated the terms of the IPO warrants and concluded that they should be equity-classified.future payments. The aggregate fair value measurement is based on significant Level 3 unobservable inputs such as

31


the probability of the IPO warrants was $0.2 million.  See Note 7 of the notes to the unaudited financial statements included elsewhereachieving a sale or licensing agreement, anticipated timelines, and discount rate. Changes in this Quarterly Report on Form 10-Q.

Liability-Classified Warrants

In connection with our private placement offering in November 2016, or the November private placement, we issued warrants to purchase 1,644,737 shares of common stock to a group of accredited investors. The warrants will be exercisable beginning May 24, 2017 at an exercise price of $10.79 per share. We evaluated the terms of the warrants and concluded that they should be liability-classified. We recognize any change in the value of the warrant liability each reporting period in the statement of operations. As of September 30, 2017, the fair value of the warrants was approximately $17.8 million, which is an increaseliability will be recognized in the consolidated statement of $11.5 million fromoperations and comprehensive loss until settlement.

Share-based compensation

The Company accounts for share-based compensation in accordance with ASC 718, “Compensation – Stock Compensation” (“ASC 718”). ASC 718 requires companies to estimate the fair value of approximately $6.3 million as of December 31, 2016.  See Note 7 of the notes to the unaudited financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Stock-Based Compensation

We measure stock options and other stock-basedequity-based payment awards granted to employees and directors based on the fair value on the date of grantgrant. The value of the portion of the award that is ultimately expected to vest is recognized as an expense over the requisite service period in the Company’s consolidated statements of operations and recognizecomprehensive loss.

The Company records the correspondingexpense for option awards using a graded vesting method. The Company accounts for forfeitures as they occur. For share-based awards granted to non-employee consultants, the measurement date is the date of grant. The compensation expense of those awards, net of estimated forfeitures,is then recognized over the requisite service period, which is generally the vesting period of the respective award. Generally, we issue

The fair value of stock options and restricted stock awards with only service-based vesting conditions and record(“options”) on the expense for these awardsgrant date is determined utilizing the Black-Scholes option-pricing model using the straight-line method.

We measuresingle-option approach. The Black-Scholes option pricing model requires the use of highly subjective and complex assumptions, including an option’s expected term and the price volatility of the underlying stock, options and other stock-based awards granted to consultants and nonemployees based ondetermine the fair value of the award on the date at which the related service is complete. We recognize thisaward.

The Company classifies share-based compensation expense over the period during which services are rendered by such consultants and nonemployees until completed. At the end of each financial reporting period prior to completion of the service, we remeasure the fair value of these awards using the then-current fair value of our common stock and updated assumption inputs in the Black-Scholes option-pricing model.

We estimate the fair value of each stock option grant using the Black-Scholes option-pricing model. Use of this model requires that we make assumptions as to the fair value of our common stock, the volatility of our common stock, the expected term of our stock options, the risk-free interest rate for a period that approximates the expected term of our stock options and our expected dividend yield. Because we lack company-specific historical and implied volatility information due in part to the limited time in which we have operated as a publicly traded company, we estimate our expected volatility based on the historical volatility of a group of publicly traded peer companies. We expect to continue to do so until such time as we have adequate historical data regarding the volatility of our traded stock price. We use the simplified method prescribed by the SEC’s Staff Accounting Bulletin No. 107, Share-Based Payment, to calculate the expected term of options granted to employees and directors. We base the expected term of options granted to consultants and nonemployees on the contractual term of the options. We determine the risk-free interest rate by reference


to the United States Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that we have never paid cash dividends and do not expect to pay any cash dividends in the foreseeable future.

There were no stock options granted prior to 2015. We recognize forfeitures as they occur and the compensation expense is reversed in the period that the forfeiture occurs.

In 2015, we began issuing stock options to employees, directors and consultants. During the periods ended September 30, 2017 and 2016, we issued common stock to consultants and advisors as compensation for services and recognized expense equal to the fair value of the shares issued. The following table summarizes the classification of our stock-based compensation expenses recognized in ourits consolidated statements of operations and comprehensive loss (in thousands):

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Research and development

 

$

121

 

 

$

104

 

 

$

402

 

 

$

286

 

General and administrative

 

 

389

 

 

 

274

 

 

 

1,081

 

 

 

729

 

 

 

$

510

 

 

$

378

 

 

$

1,483

 

 

$

1,015

 

JOBS Act

In April 2012,Income in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, was enacted. Section 107 of the JOBS Act provides that an “emerging growth company,” or EGC, can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Thus, an EGC can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.

Subject to certain conditions, as an EGC, we intend to rely on certain exemptions afforded by the JOBS Act, including the exemption from: certain requirements related to the disclosure of executive compensation in our periodic reports and proxy statements, and the requirement that we hold a nonbinding advisory vote on executive compensation and any golden parachute payments; the requirement that the auditors provide an attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act; and complying with any requirement that may be adopted by the Public Company Accounting Oversight Board, or PCAOB, regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an EGC until the earliest of the last day of the fiscal yearsame manner in which we have total annual gross revenues of approximately $1.07 billionthe award recipient’s payroll costs are classified or more;in which the last day of the fiscal year following the fifth anniversary of the date of the completion of the closing of an IPO; the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or the date on which weaward recipient’s service payments are deemed to be a large accelerated filer under the rules of the Securities and Exchange Commission, or the SEC.classified.

Results of Operations

Comparison of the Threethree months ended March 31, 2022 and Nine Months Ended September 30, 2017 and 20162021

The following table below summarizes our results of operations for the three and nine months ended September 30, 2017March 31, 2022 and 2016 (in thousands):2021:

 

For the Three Months Ended September 30,

 

 

Increase

 

 

For the Nine Months Ended September 30,

 

 

Increase

 

 

2017

 

 

2016

 

 

(Decrease)

 

 

2017

 

 

2016

 

 

(Decrease)

 

 

Three Months Ended March 31,

 

Grant revenue

 

$

 

 

$

 

 

$

 

 

$

 

 

$

352

 

 

$

(352

)

 

2022

 

 

2021

 

 

Change

 

 

(in thousands)

 

Statements of Comprehensive Income

 

 

 

 

 

 

 

License revenue

 

$

2,551

 

$

2,917

 

$

(366

)

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

3,221

 

 

 

2,723

 

 

 

498

 

 

 

9,152

 

 

 

11,247

 

 

 

(2,095

)

 

8,037

 

7,132

 

905

 

General and administrative

 

 

1,968

 

 

 

1,452

 

 

 

516

 

 

 

5,811

 

 

 

4,136

 

 

 

1,675

 

 

 

5,702

 

 

 

6,429

 

 

 

(727

)

Total operating expenses

 

 

5,189

 

 

 

4,175

 

 

 

1,014

 

 

 

14,963

 

 

 

15,383

 

 

 

(420

)

 

 

13,739

 

 

 

13,561

 

 

 

178

 

Loss from operations

 

 

(5,189

)

 

 

(4,175

)

 

 

(1,014

)

 

 

(14,963

)

 

 

(15,031

)

 

 

68

 

 

(11,188

)

 

(10,644

)

 

(544

)

Other income

 

 

141

 

 

 

27

 

 

 

114

 

 

 

220

 

 

 

65

 

 

 

155

 

Change in fair value of warrant liabilities

 

 

(5,780

)

 

 

 

 

 

(5,780

)

 

 

(11,474

)

 

 

 

 

 

(11,474

)

Other non-operating (expense) income:

 

 

 

 

 

 

 

Interest expense

 

(308

)

 

(87

)

 

(221

)

Change in fair value of contingent value rights

 

(58

)

 

 

(58

)

Other (expense) income

 

 

(533

)

 

 

1,105

 

 

 

(1,638

)

Total other non-operating (expense) income

 

 

(899

)

 

 

1,018

 

 

 

(1,917

)

Net loss before income taxes

 

(12,087

)

 

(9,626

)

 

(2,461

)

Income tax expense

 

 

 

 

 

(108

)

 

 

108

 

Net loss

 

$

(10,828

)

 

$

(4,148

)

 

$

(6,680

)

 

$

(26,217

)

 

$

(14,966

)

 

$

(11,251

)

 

 

(12,087

)

 

 

(9,734

)

 

 

(2,353

)

Grant revenue. There was no grant revenueLicensing and Research & Development Services Revenue

Revenue for the three months ended September 2017 and 2016. ThereMarch 31, 2022 was no grant revenue for the nine months ended September 30, 2017 $2.6 million compared to $0.4 million for the nine months ended September 30, 2016. The decrease was primarily due to the completion of our last NIH grant as of April 30, 2016. As of September 30, 2017, no additional funding remained available to us under any grant for the development of any of our product candidates.

Research and development expenses.

Research and development expenses were $3.2$2.9 million for the three months ended September 30, 2017, comparedMarch 31, 2021, a decrease of approximately $0.4 million. In both periods Ares exercised an option to $2.7acquire intellectual property rights, which generated $2.6 million of licensing revenue in the current period and $2.8 million of licensing revenue during the three months ended March 31, 2022 and 2021, respectively. The remaining

32


$0.3 million decrease is due to the recognition of $0.3 million in licensing and research and development services for the second molecule in the Company's License and Collaboration Agreement with Denali during the three months ended March 31, 2021. All performance obligations relating to the molecule were satisfied in February 2021 and as a result, no further revenue has been recognized since that date.

Research and development costs

Total research and development expenses were $8.0 million for the three months ended September 30, 2016. The increase of $0.5 million was due primarily to an increase in spending on preclinical studies and clinical trial related activities for inarigivir and preclinical studies for SB 11285 in the three months ended September 30, 2017.

Research and development expenses were $9.1 million for the nine months ended September 30, 2017,March 31, 2022, as compared to $11.2 million for the nine months ended September 30, 2016. The decrease of $2.1 million was due primarily to $2.7 million in non-cash charges primarily in connection with our amended and restated license agreement with BioHEP; offset by an increase of $0.4 million in spending on preclinical studies and clinical trial related activities for inarigivir and SB 11285 in the nine months ended September 30, 2017 and an increase in additional salaries and benefits of $0.2 million associated with higher headcount in the nine months ended September 30, 2017.

General and administrative expenses.

General and administrative expenses were $2.0$7.1 million for the three months ended September 30, 2017, compared to $1.5March 31, 2021. This $0.9 million for the three months ended September 30, 2016. This increase of $0.5 million wasis primarily due to an increase in non-cash charges for stock based compensationclinical CRO costs of $0.1$1.4 million additional salaries and benefitsresulting from an increased number of $0.1 million associated with higher headcount of non-research and development employeespatients on clinical trials in the three months ended September 30, 2017,our four clinical-stage programs, an increase of $0.1$1.2 million for public company related expenses in the three months ended September 30, 2017, an increase of $0.1 million for consulting relatedR&D staff-related costs, during the three months ended September 30, 2017 and an increase of $0.1 million for other general and administrative costs in the three months ended September 30, 2017.

General and administrative expenses were $5.8 million for the nine months ended September 30, 2017, compared to $4.1 million for the nine months ended September 30, 2016. This increase of $1.7 million was primarily due to an increase in non-cash charges for stock based compensation of $0.4 million additional salaries and benefits of $0.7 million associated with higher headcount of non-research and development employees in the nine months ended September 30, 2017, $0.6 million for public company related expenses incurred during the nine months ended September 30, 2017 and $0.1 million for additional rent expense for the nine months ended September 30, 2017; offset by a decrease of $0.1 million for legal and consulting relatedother costs, during the nine months ended September 30, 2017.

Other income. Other income for the three and nine months ended September 30, 2017 and 2016 is solely comprised of interest income. Interest income for the three and nine months ended September 30, 2017 was $141,000 and $220,000, respectively, and was primarily related to the interest earned on marketable securities. Interest income for the nine months ended September 30, 2016 was $27,000 and $65,000, respectively, and was primarily related to the interest earned on marketable securities.

Change in fair value of warrant liabilities. Change in fair value of warrant liabilities for the three and nine months ended September 30, 2017 was $5.8 million and $11.5 million, respectively, and was solely related to an increase in the fair value of the warrants from the November private placement, primarily due to the increase in the Company’s stock price. There were no warrant liabilities during the three and nine months ended September 30, 2016.

Liquidity and Capital Resources

Sources of Liquidity

From our inception through September 30, 2017, we have financed our operations through proceeds received from private placements of convertible notes, common stock and/or warrants; the exercise of options and warrants; NIH grant funding; and public offerings of securities. As of September 30, 2017, we had cash, cash equivalents and marketable securities totaling $52.2 million and an accumulated deficit of $77.8 million.



In August 2017, we entered into a Controlled Equity Offering Sales Agreement, or Sales Agreement, with Cantor Fitzgerald & Co., or Cantor, pursuant to which we may offer and sell, from time to time through Cantor, shares of our common stock having an aggregate offering price of up to $50.0 million. We will pay Cantor a commission rate equal to 3.0% of the aggregate gross proceeds from each sale. Shares sold under the Sales Agreement will be offered and sold pursuant to our Registration Statement on Form S-3 (Registration No. 333-218399) that was declared effective by the SEC on June 12, 2017, or the Registration Statement, and a prospectus supplement and accompanying base prospectus that we filed with the SEC on August 18, 2017.

In June 2017, we issued and sold in an underwritten public offering an aggregate of 3,269,219 shares of our common stock at $13.00 per share, which included 384,604 shares pursuant to the exercise of an option to purchase additional shares granted to the underwriters in connection with the offering. The shares issued in this offering were registered under the Securities Act pursuant to the Registration Statement. The offering resulted in $39.6 million of net proceeds, after deducting underwriting discounts and commissions and other offering expenses payable by us.

In November 2016, we entered into a definitive agreement with a group of accredited investors resulting in a private placement of 1,644,737 shares of our common stock and warrants to purchase 1,644,737 shares of common stock, which we refer to as the November private placement. These investors paid $9.12 for each share of common stock and warrant to purchase one share of common stock. The warrants will be exercisable beginning May 24, 2017 with a term of five years at an exercise price of $10.79. We completed the November private placement on November 23, 2016, resulting in approximately $15.0 million in gross proceeds. Net proceeds from this issuance after deducting placement agent fees and other offering-related expenses were $13.7 million.

In May 2016, we completed our IPO and sold an aggregate of 944,900 shares of common stock at a price to the public of $12.00 per share, which included 24,900 shares pursuant to the exercise of an option to purchase additional shares granted to the underwriters in connection with the IPO. The offering resulted in $8.2 million of net proceeds, after deducting underwriting discounts and commissions and other offering expenses payable by us. In connection with the closing of the IPO, we received approximately $5.3 million in proceeds upon the exercise of previously issued warrants to purchase 641,743 shares of common stock.

Cash Flows

The following table summarizes sources and uses of cash for each of the periods presented (in thousands):

 

 

For the Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

Net cash used in operating activities

 

$

(12,640

)

 

$

(11,708

)

Net cash used in investing activities

 

 

(19,919

)

 

 

(1,955

)

Net cash provided by financing activities

 

 

39,664

 

 

 

14,648

 

Net increase in cash, cash equivalents and restricted cash

 

$

7,105

 

 

$

985

 

Net cash used in operating activities. The use of cash in both periods resulted primarily from our net losses adjusted for non-cash charges and changes in components of working capital. Net cash used in operating activities was $12.6 million and $11.7 million during the nine months ended September 30, 2017 and 2016, respectively. The increase in cash used in operating activities for the nine months ended September 30, 2017 compared to September 30, 2016 was primarily due to an increase in net loss of $11.3 million, which were offset by a decrease in prepaid expenses, accounts payablemanufacturing costs of $0.4 million due to the timing of batch manufacturing activities and accrued expenses of $1.2 million. In addition, there was ana $1.7 million increase in the non-cashR&D tax credit, which is recorded as a deduction in R&D cost.

General and administrative expense

General and administrative expense for the three months ended March 31, 2022 decreased by approximately $0.7 million compared to the three months ended March 31, 2021, primarily due to a decrease in stock compensation expense of $0.8 million and legal and professional costs of $0.4 million, due to costs incurred in the comparative period for work in relation to the share exchange transaction with Spring Bank. These decreases were offset by increases of $0.2 million in facilities-related costs, $0.2 million in information technology costs and other costs of $0.1 million.

Other income (expense)

Other income (expense) for the three months ended March 31, 2022, consisted primarily of sublease income of $0.2 million, offset by foreign exchange expense of $0.7 million, interest expense on the term debt of $0.3 million and a change in the fair value of the warrantCVR liability of $11.5$0.1 million.

For the three months ended March 31, 2021, the total income of $0.1 million consisted of $1.0 million of foreign currency gains and $0.1 million of rental income, offset by $0.1 million of interest expense.

Liquidity and Capital Resources

Sources of liquidity

From our inception through March 31, 2022, we have not generated any revenue from product sales, and we have incurred significant operating losses and negative cash flows from our operations. We do not expect to generate significant revenue from sales of any products for several years, if at all.

As of March 31, 2022, the Company had an accumulated deficit of $90.5 million, cash of $68.8 million and an increaseworking capital of $64.6 million. The future success of the Company is dependent on its ability to successfully obtain additional working capital, obtain regulatory approval for and successfully launch and commercialize its product candidates and to ultimately attain profitable operations. Management believes that its existing cash and cash equivalents at March 31, 2022 will fund our current operating plan into the first quarter of 2023. Should our potential mitigating plans, which include additional funding through public equity, private equity, debt financing, collaboration partnerships, or other sources, not materialize, then Management would delay certain research projects and capital expenditures and eliminate certain future operating expenses to fund operations at reduced levels in non-cash stock based compensation of $0.5 million, which was offset by a decrease in non-cash common stock and warrant valuation expense related to the BioHEP license agreement of $2.8 millionorder for the nineCompany to continue as a going concern for a period of 12 months ended September 30, 2017.from the date the financial statements are issued.

Historically, we have financed our operations with proceeds from the sale and issuance of equity securities, proceeds from the issuance of notes payable and proceeds received in connection with our collaboration arrangements and for providing research and development services. We expect this historical financing trend to continue if and until we are able obtain regulatory approval for and successfully commercialize one or more of our drug candidates, although

33


there can be no assurance that we will obtain regulatory approval or successfully commercialize any of our current or planned future product candidates.

Cash Flows

The following table summarizes our cash flows for each of the periods presented:

Summarized cash flow information

 

 

 

Three Months Ended March 31,

 

 

 

2022

 

 

2021

 

 

Change

 

 

 

(in thousands)

 

Net cash used in operating activities

 

$

(11,615

)

 

 

(14,378

)

 

$

2,763

 

Net cash used in investing activities

 

 

 

 

 

(252

)

 

 

252

 

Net cash provided by financing activities

 

 

1,879

 

 

 

 

 

 

1,879

 

Effect of exchange rate changes on cash

 

 

(12

)

 

 

(216

)

 

 

204

 

Net increase in cash

 

$

(9,748

)

 

$

(14,846

)

 

$

5,098

 

Operating activities

Net cash used of $11.6 million in investingoperating activities. for the three months ended March 31, 2022, consisted of the net loss of $12.1 million adjusted for changes in operating assets and liabilities of $2.0 million and offset by non-cash charges of $2.5 million, primarily for share-based compensation expense of $1.5 million, foreign exchange losses of $0.6 million, depreciation and amortization of $0.2 million, fair value adjustment of the CVR liability of $0.1 million and non-cash interest expense of $0.1 million.

Net cash used of $14.4 million in operating activities for the three months ended March 31, 2021, was primarily due to a net loss of $9.7 million adjusted by changes in operating assets and liabilities of $6.4 million and offset by non-cash charges of $1.7 million. The non-cash charges included share-based compensation of $2.2 million, depreciation of $0.1 million and non-cash interest expense of $0.1 million, offset by foreign exchange gains of $0.7 million.

Investing activities

For the three months ended March 31, 2022 and 2021, net cash used in investing activities was $19.9zero and $0.3 million forrespectively. During the ninethree months ended September 30, 2017 compared to $2.0 million for the nine months ended September 30, 2016. TheMarch 31, 2021, net cash used in investing activities of $19.9 million in the nine months ended September 30, 2017 was primarily the result of $14.6 million in proceeds from the sale of marketable securities, offset by $34.4 million fordue to the purchase of marketable securities and $0.1 million forlaboratory equipment.

Financing activities

For the purchase of property and equipment. The cash used in investing activities of $2.0 million for the ninethree months ended September 30, 2016 was mainly due to proceeds of $4.9 million from the sale of marketable securities, offset by $6.7 million for the purchase of marketable securities and $0.2 million for the purchase of property and equipment for the nine months ended September 30, 2016.

Net cash provided by financing activities. NetMarch 31, 2022, net cash provided by financing activities was $39.7$1.9 million and $14.6. This included $2.0 million during the nine months ended September 30, 2017 and 2016, respectively. The cash provided by financing activities in the nine months ended September 30, 2017 was primarily the result of $42.5 million of gross proceedsraised net from the common stockuse of our “at the market” offering andfacility, offset by $0.1 million of proceeds from the exercise of stock options, offset by $2.9 million of offering expenses. The cash provided by


financing activities in the nine months ended September 30, 2016 was primarily the result of $11.3 million of gross proceeds received from our IPO, cash of $5.3 million for the exercise of warrantspaid to tax authorities in connection with the closing of our IPO and $0.1 million for the exercise of stock options, offset by $2.1 million in underwriting discounts and offering expenses relatedshares withheld from employees to our IPO.  cover their tax obligations upon RSU vesting.

Future Funding Requirements

We expect to continueF-star expects to incur significant and increasingsubstantial losses forin the foreseeable future. We anticipate these losses to increasefuture as our expenses increase,it conducts and we expect that our expenses will increase ifexpands its clinical trial and as we:

continue to develop and conduct clinical trials of inarigivir, including the ongoing Part A of our Phase 2 ACHIEVE trial of inarigivir for chronic HBV;

continue preclinical development of SB 11285 and our other product candidates and initiate clinical trials of SB 11285 and our other product candidates, if supported by the preclinical data;  

initiate and continue research and preclinical and clinical development efforts for our other product candidates;

seek to identify and develop additional product candidates;

seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials, if any;

establish sales, marketing, distribution and other commercial infrastructure in the future to commercialize various products for which we may obtain marketing approval, if any;

require the manufacture of larger quantities of product candidates for clinical development and potentially commercialization;

maintain, expand and protect our intellectual property portfolio;

hire and retain additional personnel, including clinical, quality control and scientific personnel;

add operational, financial and management information systems and personnel, including personnel to support our product development and help us continue to comply with our obligations as a public company; and

add equipment and physical infrastructure to support our research and development programs.

We expectactivities. Management believes that ourits existing cash and cash equivalents and marketable securities as of September 30, 2017at March 31, 2022 will enable us to fund our current operating expenses andplan into the first quarter of 2023.

The Company may continue to seek additional working capital expenditure requirements through the endsale and issuance of 2019. However, we anticipateequity securities, debt financing, collaboration arrangements or other sources. There are no assurances, however, that our existing cash, cash equivalents and marketable securitiesthe Company will not be sufficientsuccessful in raising additional working capital, or if it is able to fundraise additional development of inarigivir beyond our Phase 2 ACHIEVE clinical trial in patients with chronic HBV. We have based this estimate on assumptions thatworking capital, it may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development of inarigivir and SB 11285, we are unable to estimate the amountsdo so on commercially favorable terms. The Company’s failure to raise additional capital or enter into other financing arrangements if and when needed would have an adverse impact on its business, results of increased capital outlaysoperations and operating expenses associated with completing the researchfinancial condition and development of ourits ability to develop its product candidates.

34


Our future capital requirements both near and long-term, will depend on many factors, including, but not limited to:including:

initiation,the cost, progress, timing, costsresults of the proof-of-concept Phase 2 clinical trials of FS118 and any later-stage clinical trials for this product candidate;

the cost, progress, and results of the Phase 1 clinical trials of FS222, FS120, and SB 11285 and any later-stage clinical trials for these product candidates;
the scope, progress, results and costs of preclinical studiesdevelopment, laboratory testing and clinical trials of inarigivir, including Part A of our Phase 2 ACHIEVE clinical trial in patients with chronic HBV;

for any future product candidate;

initiation, progress, timing, coststhe number of potential new product candidates we identify and resultsdecide to develop;

the cost of preclinical studies of SB 11285;  

initiation, progress, timing, costs and results of preclinical studies andmanufacturing drug supply for the clinical trials of our other product candidates;

the time and costs involved in obtaining regulatory approval for our obligationproduct candidates and any delays we may encounter as a result of evolving regulatory requirements or adverse clinical trial results with respect to make royalty and non-royalty sublicense payments to third-party licensors, if any, under our licensing agreements;

the timing, receipt, and amount of milestone payments or royalties, if any, from inarigivir, SB 11285, or any of our other product candidates;


the number and characteristics of product candidates that we discover or in-license and develop;

the outcome, timingcosts involved in growing our organization to the size and cost of seeking regulatory review by the FDA and comparable foreign regulatory authorities, including the potentialexpertise needed to allow for the FDAresearch, development and potential commercialization of our current or comparable foreign regulatory authorities to require that we perform more studies than those that we currently expect;

any future product candidates;

fulfilling obligations under our existing collaboration agreements and the entry into new collaboration agreements;

the costs and timing of preparing, filing and prosecuting defending and enforcing any patent claims andapplications, maintaining and enforcing otherour intellectual property rights and defending any intellectual property-related claims, including any claims by third parties that we are infringing upon their intellectual property rights;

subjectthe cost of commercialization activities and costs involved in the creation of an effective sales, marketing and healthcare compliance organization for any product candidates we develop, if approved;

the potential additional expenses attributable to receipt of marketing approval,adjusting our development plans (including any supply related matters) to the COVID-19 pandemic;
the potential additional expenses attributable to adjusting our development plans (including any supply related matters) to the Ukraine conflict;
the revenue, if any, received from commercial sales of inarigivir and any other products;

the costs and timing of the implementation of commercial-scale manufacturing activities;

the costs and timing of establishing sales, marketing and distribution capabilities for anyour product candidates for which we may receive regulatorymarketing approval; and

the costs of operating as a public company.

IdentifyingCritical Accounting Policies and Significant Judgments and Estimates

Our consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of our consolidated financial statements and related disclosures requires our management to make estimates and assumptions that affect the reported amount of assets, liabilities, revenue, costs and expenses and related disclosures. We believe that the estimates and assumptions underlying the accounting policies described therein may have the greatest potential product candidatesimpact on our consolidated financial statements and, conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expecttherefore, consider these to be commercially available for many years, if ever. Accordingly, we will need to obtain substantial additional funds to achieve our business objectives.

Adequate additional fundscritical accounting policies. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may not be available to usdiffer from these current estimates based on acceptable terms, or at all. We do not currentlydifferent assumptions and under different conditions. There have any committed external source of funds. We have an effective shelf registration statement on Form S-3 (File No. 333-218399), which we refer to as the Registration Statement.  In August 2017, we entered into the Sales Agreement with Cantor pursuant to which we may offer and sell, from time to time through Cantor, shares of our common stock having an aggregate offering price of up to $50.0 million.  Shares sold under the Sales Agreement will be offered and sold pursuantbeen no material changes to the Registration StatementCompany’s critical accounting policies and a prospectus supplement and accompanying base prospectus that weestimates as disclosed in the Company’s Annual Report filed on SEC Form 10-K for the year ended December 31, 2021, filed with the SEC on August 18, 2017.  As of September 30, 2017, we had up to $107.5 million in securities available for future issuance under the Registration Statement, which includes $50.0 million in shares issuable pursuant to the Sales Agreement with Cantor. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Additional debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends and may require the issuance of warrants, which could potentially dilute the ownership interests of our stockholders.March 15, 2022.

If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development programs or any future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Contractual Obligations and Commitments

The following table summarizes our contractual obligations at September 30, 2017, and the effect such obligations are expected to have on our liquidity and cash flow in future periods (in thousands):

 

 

Payments Due by Period

 

 

 

Total

 

 

Less Than

1 Year

 

 

1 – 3

Years

 

 

3 – 5

Years

 

 

More than

5 Years

 

Operating lease commitments

 

$

624

 

 

$

194

 

 

$

430

 

 

$

0

 

 

$

 

Total

 

$

624

 

 

$

194

 

 

$

430

 

 

$

0

 

 

$

 

In addition to the amounts shown in the above table, we have contractual obligations pursuant to our amended and restated license agreement with BioHEP. Under this agreement, we have agreed to pay up to $3.5 million in development and regulatory milestone payments to BioHEP for each distinct viral indication for which we develop licensed product(s). BioHEP is also eligible to


receive tiered royalties in the low-to-mid single-digits on net product sales of licensed products by us and our affiliates and sub licensees, and a specified share of non-royalty sublicensing revenues we and our affiliates receive from sub licensees, which share of sublicensing revenues is capped at a maximum aggregate of $2.0 million under all such sublicenses. Milestone and royalty payments associated with our amended and restated license agreement with BioHEP have not been included in the above table of contractual obligations as we cannot reasonably estimate if or when they will occur.

On October 4, 2017, we entered into a New Lease.  The premises covered by the New Lease will serve as our new principal office and laboratory space.  The initial term of the New Lease is 125 months beginning on the date on which the landlord substantially completes certain renovations to the premises covered by the New Lease, which we expect to occur in approximately April 2018.   Following an eleven-month rent abatement period, we will be obligated to make monthly rent payments in the amount of $34,533, which is subject to increase by approximately 3% annually for the first five years of the New Lease and by approximately 2.5% annually thereafter. The total lease payments due during the term of the lease are approximately $4.4 million. In addition, we are responsible under the New Lease for specified costs and charges, including certain operating expenses, utilities, taxes and insurance.  

We enter into contracts in the normal course of business with third partythird-party service providers for clinical trials, preclinical research studies and testing, manufacturing and other services and products for operating purposes. We have not included our payment obligations under these contracts in the table as these contracts generally provide for termination

35


upon notice, and therefore, we believe that our non-cancelable obligations under these agreements are not material.material, and we cannot reasonably estimate the timing of, or whether they will occur. We could also enter into additional research, manufacturing, supplier and other agreements in the future, which may require up-front payments and even long-term commitments of cash.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

Recently Issued Accounting PronouncementsSmaller Reporting Company Status

In November 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash, which includes provisions intended to clarify how entities present restricted cash and restricted cash equivalentsWe are a “smaller reporting company” as defined in the Securities Exchange Act of 1934, as amended (the “Exchange Act”). We may take advantage of certain of the scaled disclosures available to smaller reporting companies. These include, but are not limited to, reduced disclosure obligations regarding executive compensation in our periodic and annual reports, exemption from the requirement to provide a compensation discussion and analysis describing compensation practices and procedures, and reduced financial statement disclosure in our registration statements, which must include two years of cash flows. Companies must showaudited financial statements rather than the changethree years of audited financial statements that are required for other public reporting companies. Smaller reporting companies are also eligible to provide such reduced financial statement disclosure in total cash, cash equivalents, restricted cashannual reports on Form 10-K. We will be able to take advantage of these scaled disclosures and restricted cash equivalents inexemptions for so long as (i) our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the statementlast business day of cash flows. The new standard is applied retrospectively and is effective forour second fiscal quarter or (ii) our annual periods beginning after December 15, 2017,revenue is less than $100.0 million during the most recently completed fiscal year and for interim periods within those annual periods, with early adoption permitted. We elected early adoption of this standard as of September 30, 2017, the first period in which we had restricted cash.  The adoption of this standard has resulted in the presentation of the change in cash, cash equivalentsour voting and restricted cashnon-voting common stock held by non-affiliates is less than $700.0 million measured on the statementlast business day of cash flows in the periods presented.our second fiscal quarter.

In March 2016, the FASB issued ASU 2016-09, Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”) to require changes to several areas of employee stock-based compensation payment accounting in an effort to simplify stock-based compensation reporting. The update revises requirements in the following areas: minimum statutory withholding, accounting for income taxes, forfeitures,Item 3. Quantitative and intrinsic value accounting for private entities. ASU 2016-09 is effective for our annual reporting periods beginning after December 15, 2016, including interim reporting periods within each annual reporting period. We adopted this standard on January 1, 2017. The update revises our requirements in the following areas:  minimum statutory withholding, accounting for income taxes, and forfeitures. Prior to adoption, we applied a 0% forfeiture rate to stock-based compensation, resulting in no cumulative effect adjustment to the opening period. Upon adoption of this standard, our accounting policy is to recognize forfeitures as they occur.Qualitative Disclosures About Market Risk.

The update requires us to recognize the income tax effect of awards in the income statement when the awards vest or are settled. It also allows us to repurchase more of an employee’s shares than we could prior to the update for tax withholding purposes without triggering a liability. The income tax related items had no effect on the current period presentation and we maintain a full valuation allowance against our deferred tax assets.



In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606), or ASC 606, which amends the guidance for revenue recognition to replace numerous industry-specific requirements. ASC 606 implements a five-step process for customer contract revenue recognition that focuses on transfer of control, as opposed to transfer of risk and rewards. ASC 606 also requires enhanced disclosures regarding the nature, amount, timing, and uncertainty of revenues and cash flows from contracts with customers. Other major provisions include ensuring the time value of money is considered in the transaction price, and allowing estimates of variable consideration to be recognized before contingencies are resolved in certain circumstances. The amendments in ASC 606 are effective for reporting periods beginning after December 15, 2016, and early adoption is not permitted. In July 2015, FASB approved the deferral of adoption by one year. Entities can transition to the standard either retrospectively or as a cumulative-effect adjustment as of the date of adoption. Until we expect material revenue to be recognized, the adoption of this standard is not expected to have an impact on our consolidated financial statements.

In January 2016, the FASB issued ASU 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities, which amends Accounting Standards Codification, or ASC, Subtopic 825-10, Financial Instruments - Overall, and includes updates on certain aspects of recognition, measurement, presentation and disclosure of financial instruments and applies to all entities that hold financial assets or owe financial liabilities. The new standard is effective for our annual period beginning after December 15, 2017, with early adoption permitted. We are currently evaluatinga smaller reporting company, as defined in Rule 12b-2 under the impact that the adoption ofExchange Act for this standard may have on our consolidated financial statements.

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which supersedes the current leasing guidancereporting period and upon adoption, will require lessees to recognize right-of-use assets and lease liabilities on the balance sheet for all leases with terms longer than 12 months. The new standard is effective for our annual period beginning after December 15, 2018, and can be early adopted by applying a modified retrospective approach for leases existing at, and entered into after, the beginning of the earliest comparable period presented in the financial statements. We are currently evaluating the impact that the adoption of this standard may have on our consolidated financial statements.

In September 2016, the FASB issued ASU 2016-15, Classification of Certain Cash Receipts and Cash Payments, which amends ASC Topic 230, Statement of Cash Flows, and includes provisions intended to reduce diversity in practice and provides guidance on eight specific statements of cash flows classification issues. The new standard is effective for our annual period ending after December 15, 2017, and for annual and interim periods thereafter, with early adoption permitted. We are currently evaluating the impact that the adoption of this standard may have on our consolidated financial statements.

In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815): I. Accounting for Certain Financial Instruments with Down Round Features and II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. Part I applies to entities that issue financial instruments such as warrants, convertible debt or convertible preferred stock that contain down round features. Part II simply replaces the indefinite deferral for certain mandatorily redeemable noncontrolling interests and mandatorily redeemable financial instruments of nonpublic entities contained within Accounting Standards Codification (ASC) Topic 480 with a scope exception and does not impact the accounting for these mandatorily redeemable instruments. This ASU is effective for public companies for the annual reporting periods beginning after December 15, 2018, and interim periods within those annual periods. Early adoption is permitted. We are currently evaluating the impact that the adoption of this standard may have on our consolidated financial statements

Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expectedrequired to have a material impact on our consolidated financial statements upon adoption.



Item 3.

Quantitative and Qualitative Disclosures About Market Risk.

We are exposed to market risk related to changes in interest rates. Our cash, cash equivalents and marketable securities of $52.2 million as of September 30, 2017, consisted of cash, money market accounts and short-term marketable debt securities. Our primary exposure to market risk is interest income sensitivity, which is affected by changes inprovide the general level of U.S. interest rates. However, because of the short-term nature of the instruments in our portfolio, an immediate 10% change in market interest rates would not be expected to have a material impact on the fair market value of our investment portfolio or on our financial condition or results of operations.information required under this item.

Item 4.

Controls and Procedures.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

OurAs of March 31, 2022, our management, withunder the participationsupervision of our principal executive officerChief Executive Officer and our principal financial officer, evaluated, asChief Financial Officer, performed an evaluation of the end of the period covered by this Quarterly Report on Form 10-Q, the effectiveness of our disclosure controls and procedures. Based on that evaluation of our disclosure controls and procedures as of September 30, 2017, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures as of such date are effective at the reasonable assurance level. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a companythe Company in the reports that it files or submits under the Exchange Act areis recorded, processed, summarized and reported within the time periods specified inby the SEC’sSEC rules and forms. Disclosure controlsforms, and procedures include, without limitation, controls and procedures designed to ensure that such information required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officerChief Executive Officer and principal financial and accounting officer,Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Inherent Limitations of Internal Controls

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarterthree months ended September 30, 2017,March 31, 2022, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

36




PART II—OTHER INFORMATION

Item 1.

Legal Proceedings.

Item 1. Legal Proceedings.

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not presently a party to any material litigation.

Item 1A.

Risk Factors.

Item 1A. Risk Factors.

In addition to the other information set forth in this report, you should carefully consider the risk factors discussed in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021,, as filed with the SEC on March 15, 2022, which could materially affect our business, financial condition, or results of operations. There have been no material changes in or additions to the risk factors includeddescribed in our Annual Report on Form 10-K forfiled with the year ended December 31, 2016SEC on March 15, 2022.

Item 2. Unregistered Sales of Equity Securities and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017.Use of Proceeds.

None.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures.

Not Applicable.

Item 5.

Other Information.

On October 26, 2017, our Board of Directors, or Board, elected Christiana Bardon, M.D., to the Board as a class II director with a term expiring at the 2020 annual meeting of stockholders. The Board also appointed Dr. Bardon to the Compensation Committee of the Board.Item 5. Other Information.

In accordance with our current non-employee director compensation policy, Dr. Bardon will receive a $35,000 annual cash retainer for service on the Board and a $5,000 annual cash retainer for service on the Compensation Committee. These cash retainers are payable quarterly in arrears. The non-employee director compensation policy includes a stock-for-fees policy, under which Dr. Bardon has elected to receive shares of our common stock in lieu of cash fees.None.

In addition, in accordance with the non-employee director compensation policy, Dr. Bardon received an option to purchase 11,000 shares of common stock upon her election to the Board, at an exercise price of $15.17, the closing share price of the common stock on the NASDAQ Capital Market on October 26, 2017. This option becomes exercisable on a monthly basis over the course of three years, subject to Dr. Bardon’s continued service as a director and, in the event of a change in control of the company, the vesting schedule of the option will accelerate in full. Dr. Bardon is also entitled to receive an option to purchase 5,500 shares of common stock on the date of each annual meeting of stockholders with an exercise price equal to the closing share price of the common stock on the NASDAQ Stock Market on the date of grant. Such option shall vest in 12 equal monthly installments while Dr. Bardon is serving as a director and, in the event of a change in control of the company, the vesting schedule of the option will accelerate in full.

Also, in connection with her election to the Board, we and Dr. Bardon entered into an indemnification agreement. The indemnification agreement is substantially the same as the form of indemnification agreement that we have entered into with our other directors, a copy of which was filed as Exhibit 10.1 to our Registration Statement on Form S-1 (File No. 333-208875) filed with the SEC on January 5, 2016 and is hereby incorporated by reference. The indemnification agreement provides that we will indemnify Dr. Bardon for certain expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by her in any action or proceeding arising out of her service as a director.

In November 2016, we entered into a definitive agreement with respect to the private placement of 1,644,737 shares of common stock and warrants to purchase 1,644,737 shares of our common stock to a group of accredited investors. All investors paid $9.12 for each share of common stock and warrant to purchase one share of common stock. The warrants are currently exercisable at an exercise price of $10.79 per share. Burrage Capital Healthcare Fund I, L.P. (“Burrage Capital”), of which Dr. Bardon serves as the Portfolio Manager, purchased 54,824 shares of common stock and warrants to purchase 54,824 shares of common stock in the private placement.  UBS Oncology Impact Fund L.P. (“Oncology Impact Fund”) purchased 603,070 shares of common stock and warrants to purchase 603,070 shares of common stock in the private placement.  Dr. Bardon’s spouse, Ansbert Gadicke, M.D., serves as the Managing Member of MPM Oncology Impact Management GP LLC, an indirect General Partner of Oncology Impact Fund. Additionally, in June 2017, we completed a public offering of 3,269,219 shares of our common stock at $13.00 per share.  Oncology Impact Fund purchased 230,769 shares of common stock at the public offering price in this public offering.  Dr. Bardon may be deemed to have a beneficial ownership interest in the shares purchased by the entities identified above.  

There are no arrangements or understandings between Dr. Bardon and any other person pursuant to which Dr. Bardon was elected as a director.

Item 6.

Exhibits.

Item 6. Exhibits.

The exhibits filed as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index set forth immediately below.prior to the signature page.


EXHIBIT37


EXHIBIT INDEX

Exhibit

Number

 

Description

 

Exhibit

Number

Description

10.1

10.1*#

Controlled Equity OfferingSM SalesExecutive Service Agreement Amendment, dated as of August 18, 2017,April 6, 2022 by and between Spring Bank Pharmaceuticals, Inc.F-star Therapeutics Ltd and Cantor Fitzgerald & Co. (incorporated by reference to Exhibit 10.1 to Spring Bank Pharmaceuticals, Inc.’s Current Report on Form 8-K filed on August 18, 2017).Eliot Forster, Ph.D.

31.1

10.2*#

Consulting Agreement Amendment, dated April 6, 2022 by and between F-star Therapeutics, Inc and Darlene Deptula-Hicks.

10.3*#

Service Agreement Amendment, dated April 6, 2022 by and between F-star Therapeutics Ltd and Neil Brewis, Ph.D.

10.4*#

Addendum to the Indefinite-Term Employment Contract, dated as of June 25, 2021, by and between F-star Therapeutics, Inc. and Louis Kayitalire

10.5*#

Employment Agreement Amendment, dated April 6, 2022 by and between F-star Therapeutics, Inc and Louis Kayitalire M.D.

31.1*

Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 99

31.2

31.2*

Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 ;lk;

32.1

32.1*

Certification of Principal Executive Officer andPursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2*

Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

101.INS

Inline XBRL Instance Document

 

 

101.SCH

Inline XBRL Taxonomy Extension Schema Document

 

 

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document

 

 

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

 

 

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document

 

 

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document

104

The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, has been formatted in Inline XBRL.

*

Filed herewith.

#

Indicates a management contract or compensatory plan, contract or arrangement.

38



SIGNATURESSIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

Spring Bank Pharmaceuticals,

F-star Therapeutics, Inc.

 

 

 

Date: October 31, 2017May 10, 2022

By:

By:

/s/ Jonathan FreveEliot R. Forster

 

 

Jonathan Freve

Eliot R. Forster, Ph.D.

 

 

President and Chief FinancialExecutive Officer and Treasurer

(Principal Financial and Accounting Officer)

39

36