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, 20172019

ORor

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

For the transition period from                     to                     

Commission File Number: 001-37718

 

Spring Bank Pharmaceuticals, 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 Street35 Parkwood Drive, Suite 210

Hopkinton, MA

01748

(Address of principal executive offices)

(Zip Code)

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

 

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

SBPH

The Nasdaq Stock Market, LLC

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

Indicate by check mark whether the registrant has submitted electronically 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 registrant was required to submit and post such files).    Yes      No  

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

Large accelerated filer

Accelerated filer

 

 

 

 

Non-accelerated filer

  (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 registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes      No  

As of October 31, 2017,November 6, 2019, the registrant had 12,951,03316,476,342 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 


 

Spring Bank Pharmaceuticals, Inc.

 

INDEX

 

 

 

Page 

 

PART I. FINANCIAL INFORMATION

Page    

Item 1.

Consolidated Financial Statements (Unaudited)

 

 

Condensed Consolidated Balance Sheets

3

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

4

 

Condensed Consolidated Statements of Cash FlowsStockholders’ Equity

5

 

Consolidated Statements of Cash Flows

7

Notes to Unaudited Condensed Consolidated Financial Statements

68

Item 2.

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

2024

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

3336

Item 4.

Controls and Procedures

3336

 

 

PART II. OTHER INFORMATION

 

Item 1.

Legal Proceedings

3437

Item 1A.

Risk Factors

3437

Item 5.2.

Other InformationUnregistered Sales of Equity Securities and Use of Proceeds

3438

Item 6.

Exhibits

3438

Exhibit Index

3539

Signatures

3640

 

 

 

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 to date 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, 20162018, as filed with the Securities and Exchange Commission on March 11, 2019, 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—FINANCIAL INFORMATION

Item 1.

Financial Statements.

SPRING BANK PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

(In Thousands, Except Share and Per Share Data)

 

 

September 30,

 

 

December 31,

 

 

September 30,

 

 

December 31,

 

 

2017

 

 

2016

 

 

2019

 

 

2018

 

ASSETS

 

(unaudited)

 

 

 

 

 

 

(unaudited)

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

17,539

 

 

$

10,684

 

 

$

34,371

 

 

$

14,724

 

Marketable securities

 

 

34,640

 

 

 

14,046

 

 

 

28,778

 

 

 

32,914

 

Prepaid expenses and other current assets

 

 

850

 

 

 

840

 

 

 

1,727

 

 

 

1,649

 

Total current assets

 

 

53,029

 

 

 

25,570

 

 

 

64,876

 

 

 

49,287

 

Marketable securities, long-term

 

 

 

 

 

752

 

 

 

 

 

 

16,804

 

Property and equipment, net

 

 

534

 

 

 

522

 

 

 

2,264

 

 

 

2,319

 

Operating lease right-of-use assets

 

 

2,784

 

 

 

 

Restricted cash

 

 

250

 

 

 

 

 

 

234

 

 

 

234

 

Other assets

 

 

35

 

 

 

35

 

 

 

35

 

 

 

167

 

Total

 

$

53,848

 

 

$

26,879

 

 

$

70,193

 

 

$

68,811

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,773

 

 

$

1,519

 

 

$

2,986

 

 

$

1,880

 

Accrued expenses and other current liabilities

 

 

2,312

 

 

 

1,982

 

 

 

1,998

 

 

 

2,367

 

Operating lease liabilities, current

 

 

343

 

 

 

 

Total current liabilities

 

 

4,085

 

 

 

3,501

 

 

 

5,327

 

 

 

4,247

 

Term loan, net of unamortized discount

 

 

19,011

 

 

 

 

Warrant liabilities

 

 

17,807

 

 

 

6,333

 

 

 

450

 

 

 

8,511

 

Operating lease liabilities, noncurrent

 

 

2,962

 

 

 

 

Other long-term liabilities

 

 

32

 

 

 

27

 

 

 

27

 

 

 

193

 

Total liabilities

 

 

21,924

 

 

 

9,861

 

 

 

27,777

 

 

 

12,951

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 11)

 

 

 

 

 

 

 

 

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

 

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

2019 and December 31, 2018; no shares issued or outstanding at September 30,

2019 and December 31, 2018

 

 

 

 

 

 

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

2019 and December 31, 2018; 16,476,342 and 16,434,614 shares issued and

outstanding at September 30, 2019 and December 31, 2018, respectively

 

 

2

 

 

 

2

 

Additional paid-in capital

 

 

109,682

 

 

 

68,559

 

 

 

161,382

 

 

 

157,931

 

Accumulated deficit

 

 

(77,752

)

 

 

(51,535

)

 

 

(118,730

)

 

 

(102,068

)

Other comprehensive loss

 

 

(7

)

 

 

(7

)

Accumulated other comprehensive loss

 

 

(238

)

 

 

(5

)

Total stockholders’ equity

 

 

31,924

 

 

 

17,018

 

 

 

42,416

 

 

 

55,860

 

Total

 

$

53,848

 

 

$

26,879

 

 

$

70,193

 

 

$

68,811

 

 

See accompanying notes to consolidated financial statements.

 

 


SPRING BANK PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(In Thousands, Except Share and Per Share Data)

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Grant revenue

 

$

 

 

$

 

 

$

 

 

$

352

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

3,221

 

 

 

2,723

 

 

 

9,152

 

 

 

11,247

 

 

$

5,228

 

 

$

5,656

 

 

$

18,070

 

 

$

15,188

 

General and administrative

 

 

1,968

 

 

 

1,452

 

 

 

5,811

 

 

 

4,136

 

 

 

2,247

 

 

 

2,059

 

 

 

7,547

 

 

 

6,681

 

Total operating expenses

 

 

5,189

 

 

 

4,175

 

 

 

14,963

 

 

 

15,383

 

 

 

7,475

 

 

 

7,715

 

 

 

25,617

 

 

 

21,869

 

Loss from operations

 

 

(5,189

)

 

 

(4,175

)

 

 

(14,963

)

 

 

(15,031

)

 

 

(7,475

)

 

 

(7,715

)

 

 

(25,617

)

 

 

(21,869

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

141

 

 

 

27

 

 

 

220

 

 

 

65

 

 

 

271

 

 

 

271

 

 

 

957

 

 

 

603

 

Interest expense

 

 

(63

)

 

 

 

 

 

(63

)

 

 

 

Change in fair value of warrant liabilities

 

 

(5,780

)

 

 

 

 

 

(11,474

)

 

 

 

 

 

355

 

 

 

(1,336

)

 

 

8,061

 

 

 

3,837

 

Net loss

 

 

(10,828

)

 

 

(4,148

)

 

 

(26,217

)

 

 

(14,966

)

 

 

(6,912

)

 

 

(8,780

)

 

 

(16,662

)

 

 

(17,429

)

Unrealized (loss) gain on marketable securities

 

 

(10

)

 

 

(3

)

 

 

(7

)

 

 

18

 

Unrealized loss on marketable securities

 

 

(20

)

 

 

(14

)

 

 

(233

)

 

 

(13

)

Comprehensive loss

 

$

(10,838

)

 

$

(4,151

)

 

$

(26,224

)

 

$

(14,948

)

 

$

(6,932

)

 

$

(8,794

)

 

$

(16,895

)

 

$

(17,442

)

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

 

Net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.42

)

 

$

(0.59

)

 

$

(1.01

)

 

$

(1.27

)

Diluted

 

$

(0.42

)

 

$

(0.59

)

 

$

(1.01

)

 

$

(1.39

)

Weighted-average number of shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

16,459,155

 

 

 

14,841,197

 

 

 

16,446,582

 

 

 

13,677,375

 

Diluted

 

 

16,459,155

 

 

 

14,841,197

 

 

 

16,446,582

 

 

 

15,311,152

 

 

See accompanying notes to consolidated financial statements.

 



SPRING BANK PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2019 AND 2018

(In Thousands, Except Share and Per Share Data)

For the Three Months Ended

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

 

 

Other

Comprehensive

 

 

Total

Stockholders’

 

September 30, 2019

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

Balance at June 30, 2019

 

 

16,459,155

 

 

$

2

 

 

$

159,975

 

 

$

(111,818

)

 

$

(218

)

 

$

47,941

 

Stock-based compensation

 

 

 

 

 

 

 

 

752

 

 

 

 

 

 

 

 

 

752

 

Issuance of common stock for services rendered

 

 

17,187

 

 

 

 

 

 

59

 

 

 

 

 

 

 

 

 

59

 

Issuance of warrants in connection with term loan

 

 

 

 

 

 

 

 

552

 

 

 

 

 

 

 

 

 

552

 

Issuance of warrants to a service provider

 

 

 

 

 

 

 

 

19

 

 

 

 

 

 

 

 

 

19

 

Offering costs in connection with common stock

     offering

 

 

 

 

 

 

 

 

25

 

 

 

 

 

 

 

 

 

25

 

Net unrealized loss on marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(20

)

 

 

(20

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(6,912

)

 

 

 

 

 

(6,912

)

Balance at September 30, 2019

 

 

16,476,342

 

 

$

2

 

 

$

161,382

 

 

$

(118,730

)

 

$

(238

)

 

$

42,416

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the Three Months Ended

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

 

 

Other

Comprehensive

 

 

Total

Stockholders’

 

September 30, 2018

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

Balance at June 30, 2018

 

 

13,182,567

 

 

$

1

 

 

$

118,541

 

 

$

(87,863

)

 

$

(22

)

 

$

30,657

 

Stock-based compensation

 

 

 

 

 

 

 

 

680

 

 

 

 

 

 

 

 

 

680

 

Issuance of common stock for services rendered

 

 

2,525

 

 

 

 

 

 

30

 

 

 

 

 

 

 

 

 

30

 

Issuance of common stock in connection with

     offering, net of issuance costs

 

 

3,246,079

 

 

 

1

 

 

 

37,959

 

 

 

 

 

 

 

 

 

37,960

 

Issuance costs in connection with at-the-market

     offering

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

 

 

 

(1

)

Net unrealized gain (loss) on marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(14

)

 

 

(14

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(8,780

)

 

 

 

 

 

(8,780

)

Balance at September 30, 2018

 

 

16,431,171

 

 

$

2

 

 

$

157,209

 

 

$

(96,643

)

 

$

(36

)

 

$

60,532

 

See accompanying notes to consolidated financial statements.



SPRING BANK PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2019 AND 2018

(In Thousands, Except Share and Per Share Data)

For the Nine Months Ended

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

 

 

Other

Comprehensive

 

 

Total

Stockholders’

 

September 30, 2019

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

Balance at December 31, 2018

 

 

16,434,614

 

 

$

2

 

 

$

157,931

 

 

$

(102,068

)

 

$

(5

)

 

$

55,860

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,647

 

 

 

 

 

 

 

 

 

2,647

 

Issuance of common stock for services rendered

 

 

41,128

 

 

 

 

 

 

202

 

 

 

 

 

 

 

 

 

202

 

Issuance of common stock in connection with

     at-the-market offering

 

 

600

 

 

 

 

 

 

6

 

 

 

 

 

 

 

 

 

6

 

Issuance of warrants in connection with term loan

 

��

 

 

 

 

 

 

552

 

 

 

 

 

 

 

 

 

552

 

Issuance of warrants to a service provider

 

 

 

 

 

 

 

 

19

 

 

 

 

 

 

 

 

 

19

 

Offering costs in connection with common stock

     offering

 

 

 

 

 

 

 

 

25

 

 

 

 

 

 

 

 

 

25

 

Net unrealized loss on marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(233

)

 

 

(233

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(16,662

)

 

 

 

 

 

(16,662

)

Balance at September 30, 2019

 

 

16,476,342

 

 

$

2

 

 

$

161,382

 

 

$

(118,730

)

 

$

(238

)

 

$

42,416

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the Nine Months Ended

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

 

 

Other

Comprehensive

 

 

Total

Stockholders’

 

September 30, 2018

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

Balance at December 31, 2017

 

 

12,961,993

 

 

$

1

 

 

$

113,984

 

 

$

(79,214

)

 

$

(23

)

 

$

34,748

 

Stock-based compensation

 

 

 

 

 

 

 

 

1,978

 

 

 

 

 

 

 

 

 

1,978

 

Issuance of common stock for services rendered

 

 

5,770

 

 

 

 

 

 

76

 

 

 

 

 

 

 

 

 

76

 

Issuance of common stock in connection with

     offering, net of issuance costs

 

 

3,246,079

 

 

 

1

 

 

 

37,959

 

 

 

 

 

 

 

 

 

37,960

 

Issuance of common stock in connection with

     at-the-market offering, net of issuance costs

 

 

217,329

 

 

 

 

 

 

3,212

 

 

 

 

 

 

 

 

 

3,212

 

Net unrealized gain on marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13

)

 

 

(13

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(17,429

)

 

 

 

 

 

(17,429

)

Balance at September 30, 2018

 

 

16,431,171

 

 

$

2

 

 

$

157,209

 

 

$

(96,643

)

 

$

(36

)

 

$

60,532

 

See accompanying notes to consolidated financial statements.

 


SPRING BANK PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(In Thousands)

 

 

For the Nine Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

2017

 

 

2016

 

 

2019

 

 

2018

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(26,217

)

 

$

(14,966

)

 

$

(16,662

)

 

$

(17,429

)

Adjustments for:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

115

 

 

 

87

 

 

 

263

 

 

 

193

 

Loss on the disposal of property and equipment

 

 

 

 

 

16

 

Operating lease right-of-use asset amortization

 

 

196

 

 

 

 

Change in fair value of warrant liabilities

 

 

11,474

 

 

 

 

 

 

(8,061

)

 

 

(3,837

)

Non-cash investment income (losses)

 

 

(50

)

 

 

28

 

Non-cash interest expense

 

 

10

 

 

 

 

Non-cash investment income

 

 

(60

)

 

 

361

 

Non-cash stock-based compensation

 

 

1,483

 

 

 

1,015

 

 

 

2,825

 

 

 

2,062

 

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

 

 

 

 

 

2,780

 

Non-cash issuance of warrants to a service provider

 

 

19

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

(10

)

 

 

(746

)

 

 

(78

)

 

 

(449

)

Other assets

 

 

 

 

 

(35

)

 

 

132

 

 

 

(46

)

Accounts payable

 

 

254

 

 

 

148

 

 

 

1,106

 

 

 

(326

)

Accrued expenses and other liabilities

 

 

311

 

 

 

(19

)

 

 

(82

)

 

 

1,098

 

Operating lease liabilities

 

 

(79

)

 

 

 

Net cash used in operating activities

 

 

(12,640

)

 

 

(11,708

)

 

 

(20,471

)

 

 

(18,357

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from sale of marketable securities

 

 

26,767

 

 

 

28,837

 

Purchases of marketable securities

 

 

(34,397

)

 

 

(6,693

)

 

 

(6,000

)

 

 

(50,000

)

Proceeds from sale of marketable securities

 

 

14,605

 

 

 

4,894

 

Purchases of property and equipment

 

 

(127

)

 

 

(156

)

 

 

(208

)

 

 

(1,913

)

Net cash used in investing activities

 

 

(19,919

)

 

 

(1,955

)

Net cash provided by (used in) investing activities

 

 

20,559

 

 

 

(23,076

)

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

 

Proceeds from term loan and warrants

 

 

20,000

 

 

 

 

Issuance costs in connection with term loan and warrants

 

 

(447

)

 

 

 

Proceeds from issuance of common stock in connection with at-the-market offering,

net of issuance costs

 

 

6

 

 

 

3,212

 

Proceeds from issuance of common stock, net of issuance costs

 

 

 

 

 

37,959

 

Cash provided by financing activities

 

 

39,664

 

 

 

14,648

 

 

 

19,559

 

 

 

41,171

 

Net increase in cash, cash equivalents and restricted cash

 

 

7,105

 

 

 

985

 

Cash and cash equivalents, beginning of period

 

 

10,684

 

 

 

4,347

 

Net increase (decrease) in cash, cash equivalents and restricted cash

 

 

19,647

 

 

 

(262

)

Cash, cash equivalents and restricted cash, beginning of period

 

 

14,958

 

 

 

24,133

 

Cash, cash equivalents and restricted cash, end of period

 

$

17,789

 

 

$

5,332

 

 

$

34,605

 

 

$

23,871

 

Supplemental disclosures of cash flow information:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash paid for taxes

 

$

1

 

 

$

1

 

 

$

21

 

 

$

3

 

Cash paid for interest

 

$

 

 

$

 

Supplemental disclosures of noncash financing activities:

 

 

 

 

 

 

 

 

Issuance of common stock warrants in connection with initial public offering

 

$

 

 

$

218

 

Cash paid for interest, net

 

$

53

 

 

$

 

 

See accompanying notes to consolidated financial statements.

 

 


Spring Bank Pharmaceuticals, Inc.

Notes to Consolidated Financial Statements

 

 

1. NATURE OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Nature of Business

Spring Bank Pharmaceuticals, Inc. (the “Company”) is a clinical-stage biopharmaceutical company engaged in the discovery and development of a novel class of therapeutics using a proprietary small molecule nucleic acid hybrid (“SMNH”) chemistrynucleotide platform. The Company is developing its most advanced SMNH product candidate, inarigivir soproxil (“inarigivir”) (formerly known as SB 9200), for the treatment of viral diseases.chronic hepatitis B virus. Since inception in 2002 and prior to its initial public offering (“IPO”) in May 2016, the Company built its technology platform and product candidate pipeline, using a semi-virtual business model, supported by grants and direct funding from the United States National Institutes of Health (“NIH”) as well as through private financings. In September 2015, theThe Company formed ahas three wholly owned subsidiary,subsidiaries: Sperovie Biosciences, Inc. andformed in September 2015, SBP Securities Corporation formed in December 2016 the Companyand SBP International Limited formed a wholly owned subsidiary, SBP Securities Corporation.in May 2019.

 

The Company’s success is dependent upon its ability to successfully complete clinical development and obtain regulatory approval of its product candidates, successfully commercialize approved products, generate revenue, and, ultimately, attain profitable operations. The Company’s operations to date have been primarily limited to financing and staffing the Company and the development of inarigivir, SB 11285, SB 9225 and the Company’s other product candidates.

Basis of Presentation and Liquidity

The accompanying 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 number of shares of common stock set forth in the financial statements and notes thereto have been retroactively adjusted for all periods presented to give effect to the reverse stock split, including reclassifying an amount equal to the reduction in par value of common stock to additional paid-in capital.

The accompanying interim financial statements as of September 30, 20172019 and for the three and nine months ended September 30, 20172019 and 2016,2018, and related interim information contained within the notes to the financial statements, are unaudited. In management’s opinion, the unaudited interim consolidated financial statements have been prepared on the same basis as the Company’s audited financial statements and include all adjustments (including normal recurring adjustments) necessary for the fair presentation of the Company’s financial position as of September 30, 2017,2019, results of operations for the three and nine months ended September 30, 20172019 and 2016,2018, statement of stockholders’ equity for the three and nine months ended September 30, 2019 and 2018 and its cash flows for the nine months ended September 30, 20172019 and 2016.2018. These interim financial statements should be read in conjunction with the Company’s audited financial statements and accompanying notes contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016,2018, as filed with the Securities and Exchange Commission (“SEC”) on February 14, 2017.March 11, 2019. The results for the three and nine months ended September 30, 20172019 are not necessarily indicative of the results expected for the full fiscal year or any interim period.

As of September 30, 2017,2019, the Company had an accumulated deficit of $77.8$118.7 million and $52.2$63.1 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, SB 9225 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 consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Sperovie Biosciences, Inc., SBP Securities Corporation and SBP Securities Corporation.International Limited. Sperovie Biosciences, Inc. had operations consisting mainly of legal fees associated with intellectual property activities as of September 30, 2017.2019. Sperovie Biosciences, Inc. is a joint borrower with the Company under the Company’s term loan (see Note 9). SBP Securities Corporation had assets primarily related to investments in marketable securities and operations consisting primarily of interest income as of September 30, 2017.2019. SBP International Limited had operations consisting mainly of clinical trial oversight, including European data protection oversight, as of September 30, 2019. All intercompany balances and transactions have been eliminated in consolidation.


Use of Estimates

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates relied upon in preparing the accompanying financial statements related to the fair value of common stock and warrant liabilities,warrants, 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 actual results may differ from these estimates.

Cash and 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, 20172019 and December 31, 20162018 are money market fund investments of $15,164,000$32.5 million and $9,507,000,$13.3 million, respectively, which are reported at fair value (Note(see Note 5).

Restricted Cash

As of September 30, 2019 and December 31, 2018, restricted cash consists of approximately $234,000, which is held as a security deposit required in conjunction with a lease agreement for the Company’s principal office and laboratory space entered into in October 2017.

Concentration of Credit Risk

Financial instruments that subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, restricted cash and marketable securities. Substantially all of the Company’s cash is held at financial institutions that management believes to be of high-credithigh credit quality. Deposits with these financial institutions may 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. The Company did not have any sources of revenue for the three and nine months ended September 30, 2017.

Investments in Marketable Securities

The Company invests excess cash balances 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, the Company considers all available evidence to evaluate the extent to which the decline is “other than temporary,” including the intention to sell and, if so, marks the investment to market through a charge to the Company’s consolidated statements of operations and comprehensive loss.



Property and Equipment, Net

Property and equipment are recorded at cost. Costs associated with maintenance and repairs are expensed as incurred. Depreciation and amortization areis provided using the straight-line method over the estimated useful lives:

Asset Category

 

Useful Life

Equipment

 

5-7 years

Furniture and fixtures

 

5 years

Leasehold improvements

 

Lesser of 10 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 operating lease right-of-use (“ROU”) assets, other current liabilities and operating lease liabilities 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 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. ThroughAs of September 30, 2017,2019, no such impairment has occurred.

Deferred Rent

The Company’s operating leases include rent escalation payment terms and other incentives received from landlords. Deferred rent represents the difference between actual operating lease payments due and straight-line rent expense over the term of the lease, which is recorded in accrued expenses and other current liabilities. The Company had deferred aggregate rent for its research and development facility in Milford, Massachusetts and its headquarters in Hopkinton, Massachusetts of $35,000 and $35,000 as of September 30, 2017 and December 31, 2016, respectively.

Revenue Recognition

The Company recognizes revenue when all of the following criteria are met: there is persuasive evidence of an arrangement, the fee is fixed or determinable, delivery has occurred or services have been rendered and collection 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.

Research and Development Costs

Research and development expenses consist primarily of costs incurred for the Company’s research activities, including discovery efforts, and the development of 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 the Company’s behalf as well as contract manufacturing organizations, or CMOs, that manufacture drug products 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;

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.

The Company expenses research and development costs as incurred. The Company recognizes external development costs based on an evaluation of the progress to completion of specific tasks using information provided to the Company by its vendors 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.


Warrants

The Company reviewsaccounts for freestanding warrants within stockholders equity or as liabilities based on the termscharacteristics and provisions of alleach instrument. The Company evaluates outstanding warrants issuedin accordance with ASC 480, Distinguishing Liabilities from Equity, and classifiesASC 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 permanentstockholders 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.without subsequent remeasurement. Warrants that do not meet thisthe criteria are classified as liabilities and remeasured to their fair value at the end of each reporting period.



Stock-Based Compensation

The Company’s stock-based payments include stock options, performance-based restricted stock units (“RSUs”) and grants of common stock, including common stock subject to vesting. 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 dateCompany accounts for nonemployee awards is the date the services are completed, resulting in periodic adjustments to stock-based compensation during the vesting period for changes inforfeitures as they occur.

The Company measures the fair value of the awards. Stock-based compensation costs for nonemployees are recognized as expense overperformance-based restricted stock units relating to the vesting period ontotal share return performance using a straight-line basis.Monte Carlo valuation model. The Company measures the fair value of the performance-based restricted stock units relating to the milestone performance goals using the fair value method and the probability that the specified performance criteria will be met. Each quarter the Company updates its assessment of the probability that the specified milestone criteria will be achieved and adjusts its estimate of the fair value, if necessary. 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, a term loan 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(see Note 5.5). The fair value of the term loan approximates its face value given the close proximity of the execution of the term loan to September 30, 2019.

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

For the three and nine months ended September 30, 20172019, both methods are equivalent and December 31, 2016,for the three months ended September 30, 2018, both methods are equivalent. CommonFor the nine months ended September 30, 2018, diluted net loss per share amounts were calculated based on the dilutive effect of the total number of shares of common stock preferred stockrelated to the November 2016 Private Placement warrants and the change in the fair value of the warrant issuances areliability. Basic and diluted net loss per share is described further in Note 7.2.


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, 20172019 and December 31, 2016,2018, 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 its principal office and laboratory space in Hopkinton, Massachusetts and previously leased 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, 2017,2019, 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,August 2018, the Financial Accounting Standards Board (“FASB”)FASB issued Accounting Standards Update (“ASU”) 2016-18,ASU 2018-13, StatementFair Value Measurement (Topic 820), Disclosure Framework – Changes to the Disclosure Requirement for Fair Value Measurement. This ASU removes, modifies and adds certain disclosure requirements 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.ASC Topic 820. The new standard is applied retrospectively andASU is effective for our annualall entities for fiscal years, and interim periods within those fiscal years, 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.2019. The Company is currently evaluating the impact that the adoption of this standard may have on itsthe Company’s consolidated financial statements.

In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 Leases (Topic 842), which supersedes the current leasing guidance and upon adoption, will requirerequires lessees to recognize right-of-use assets and lease liabilitiesmost leases on thetheir balance sheet for all leases with terms longer than 12 months.as a right-of-use asset and a lease liability. Leases are classified as either operating or finance, and classification is based on criteria similar to current lease accounting, but without explicit bright lines. In July 2018, the FASB issued ASU No. 2018-10, “Codification Improvements to Topic 842, Leases” (“ASU 2018-10”), which provides narrow amendments to clarify how to apply certain aspects of the new lease standard, and ASU No. 2018-11, “Leases (Topic 842) – Targeted Improvements” (ASU 2018-11), which addresses implementation issues related to the new lease standard. The new standardguidance is effective for the Company for the annual periodreporting periods beginning after December 15, 2018 and can beinterim periods within those fiscal years, and early adopted by applying a modified retrospective approach for leases existingadoption is permitted. Under this standard, disclosures are required to enable users of financial statements in assessing the amount, timing, and uncertainty of cash flows arising from leases. The standard permits two transition methods, (1) to apply the new lease requirements at and entered into after, the beginning of the earliest comparable period presented, inor (2) to apply the financial statements. new lease requirements at the effective date. Under both transition methods there is a cumulative effect adjustment.


The Company is currently evaluatingadopted the standard on the effective date of January 1, 2019 by applying the new lease requirements at the effective date. Prior periods continue to be presented based on the accounting standards originally in effect for such periods. The Company also elected the package of practical expedients permitted under the transition guidance within the new standard, which, among other things, allows the Company to carry forward the historical lease classification. The Company will also apply the practical expedient not to separate lease and non-lease components for new and modified leases commencing after adoption. The standard had an impact thatof approximately $3.0 million on the adoption of this standard may haveCompany’s assets and $3.4 million on its consolidated financial statements.

In September 2016, the FASB issued ASU 2016-15, Classificationliabilities, as 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 effectiveJanuary 1, 2019, for the Company forrecognition of right-of-use assets and lease liabilities, which are primarily related to the annual period ending after December 15, 2017, and for annual and interim periods thereafter, with early adoption permitted.lease of its corporate headquarters in Hopkinton, Massachusetts. The Company is currently evaluatingstandard did not have a material impact on the impact that the adoptionCompany’s results of this standard may have on its consolidated financial statements.operations or liquidity (see Note 10).

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 thatadopted this standard as of January 1, 2019; however, the adoption of this standard may have on itsdid not impact the Company’s 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

)

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Net loss

 

$

(6,912

)

 

$

(8,780

)

 

$

(16,662

)

 

$

(17,429

)

Less: decrease in change in fair value of warrant liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,837

)

Net loss available to common shareholders

 

 

 

 

 

 

 

 

 

 

 

 

 

$

(21,266

)

Weighted-average number of shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

16,459,155

 

 

 

14,841,197

 

 

 

16,446,582

 

 

 

13,677,375

 

Effect of dilutive securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock warrants

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,633,777

 

Dilutive potential common shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

15,311,152

 

Net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.42

)

 

$

(0.59

)

 

$

(1.01

)

 

$

(1.27

)

Diluted

 

$

(0.42

)

 

$

(0.59

)

 

$

(1.01

)

 

$

(1.39

)

 

DilutedFor the three and nine months ended September 30, 2019, the diluted net loss per common share is the same as basic net loss per common share and for all periods presented.the three months ended September 30, 2018, the diluted net loss per common share is the same as basic net loss per common share. For the nine months ended September 30, 2018, the diluted net loss per common share amounts were calculated based on the dilutive effect of the total number of shares of common stock related to the November 2016 Private Placement warrants of 1,633,777 shares and the change in the fair value of the warrant liability of $3.8 million.

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 Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Convertible debt

 

 

2,329,143

 

 

 

 

 

 

2,329,143

 

 

 

 

Common stock warrants

 

 

1,927,124

 

 

 

1,662,124

 

 

 

1,927,124

 

 

 

28,347

 

Stock options, RSUs and inducement awards

 

 

1,948,115

 

 

 

1,349,565

 

 

 

1,948,115

 

 

 

1,349,565

 

 

 

 

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, 20172019 and December 31, 20162018 (in thousands):

 

 

September 30,

 

 

December 31,

 

 

September 30,

 

 

December 31,

 

Investments - Current:

 

2017

 

 

2016

 

 

2019

 

 

2018

 

Debt securities - available for sale

 

$

34,640

 

 

$

14,046

 

 

$

28,778

 

 

$

32,914

 

Total

 

$

34,640

 

 

$

14,046

 

 

$

28,778

 

 

$

32,914

 

 

 

 

��

 

 

 

 

 

 

 

 

 

 

 

 

Investments - Noncurrent:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Debt securities - available for sale

 

$

 

 

$

752

 

 

$

 

 

$

16,804

 

Total

 

$

 

 

$

752

 

 

$

 

 

$

16,804

 

A summary of the Company’s available-for-sale classified investments as of September 30, 2019 and December 31, 2018 consisted of the following (in thousands):

 

At September 30, 2017

 

 

At September 30, 2019

 

 

Cost

Basis

 

 

Unrealized

Gains

 

 

Unrealized

Losses

 

 

Fair

Value

 

 

Cost

Basis

 

 

Accumulated

Unrealized

Gains

 

 

Accumulated

Unrealized

Losses

 

 

Fair

Value

 

Investments - Current:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Commercial paper

 

$

14,345

 

 

$

 

 

$

 

 

$

14,345

 

Corporate bonds

 

 

18,309

 

 

 

 

 

 

(7

)

 

 

18,302

 

 

$

11,055

 

 

$

 

 

$

(74

)

 

$

10,981

 

United States treasury securities

 

 

1,993

 

 

 

 

 

 

 

 

 

1,993

 

 

 

17,961

 

 

 

 

 

 

(164

)

 

$

17,797

 

Total

 

$

34,647

 

 

$

 

 

$

(7

)

 

$

34,640

 

 

$

29,016

 

 

$

 

 

$

(238

)

 

$

28,778

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

At December 31, 2016

 

 

At December 31, 2018

 

 

Cost

Basis

 

 

Unrealized

Gains

 

 

Unrealized

Losses

 

 

Fair

Value

 

 

Cost

Basis

 

 

Accumulated

Unrealized

Gains

 

 

Accumulated

Unrealized

Losses

 

 

Fair

Value

 

Investments - Current:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Agency bonds

 

$

452

 

 

$

 

 

$

 

 

$

452

 

Commercial paper

 

 

2,947

 

 

 

 

 

 

 

 

 

2,947

 

Corporate bonds

 

 

8,499

 

 

 

 

 

 

(7

)

 

 

8,492

 

 

$

16,028

 

 

$

 

 

$

(19

)

 

$

16,009

 

United States treasury securities

 

 

2,155

 

 

 

 

 

 

 

 

 

2,155

 

 

 

16,913

 

 

 

 

 

 

(8

)

 

 

16,905

 

Total

 

$

14,053

 

 

$

 

 

$

(7

)

 

$

14,046

 

 

$

32,941

 

 

$

 

 

$

(27

)

 

$

32,914

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Investments - Noncurrent:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Corporate bonds

 

 

752

 

 

 

 

 

 

 

 

 

752

 

 

$

4,930

 

 

$

2

 

 

$

 

 

$

4,932

 

United States treasury securities

 

 

11,852

 

 

 

20

 

 

 

 

 

 

11,872

 

Total

 

$

752

 

 

$

 

 

$

 

 

$

752

 

 

$

16,782

 

 

$

22

 

 

$

 

 

$

16,804

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The amortized cost and fair value of the Company’s available-for-sale investments, by contract maturity, as of September 30, 20172019 consisted of the following (in thousands):

 

 

Amortized Cost

 

 

Fair Value

 

Due in one year or less

 

$

29,016

 

 

$

28,778

 

Due after one year through two years

 

 

 

 

 

 

Total

 

$

29,016

 

 

$

28,778

 



4. PROPERTY AND EQUIPMENT, NET

Property and equipment as of September 30, 2019 and December 31, 2018 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,

 

 

September 30,

 

 

December 31,

 

 

2017

 

 

2016

 

 

2019

 

 

2018

 

Equipment

 

$

683

 

 

$

576

 

 

$

1,278

 

 

$

1,064

 

Furniture and fixtures

 

 

144

 

 

 

140

 

 

 

385

 

 

 

400

 

Leasehold improvements

 

 

149

 

 

 

133

 

 

 

1,356

 

 

 

1,347

 

Total property and equipment

 

 

976

 

 

 

849

 

 

 

3,019

 

 

 

2,811

 

Less: accumulated depreciation and amortization

 

 

(442

)

 

 

(327

)

 

 

(755

)

 

 

(492

)

Property and equipment, net

 

$

534

 

 

$

522

 

 

$

2,264

 

 

$

2,319

 

 

Depreciation and amortization expense for the three and nine months ended September 30, 20172019 was $39,000$92,000 and $115,000,$263,000, respectively. Depreciation and amortization expense for the three and nine months ended September 30, 20162018 was $30,000$107,000 and $87,000,$193,000, 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.

A summary of the assets and liabilities that are measured at fair value as of September 30, 2019 and December 31, 2018 is as follows (in thousands):

 

 

 

 

 

 

Fair Value Measurement at

September 30, 2019

 

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)

 

$

32,526

 

 

$

32,526

 

 

$

 

 

$

 

Fixed income securities

 

 

28,778

 

 

 

 

 

 

28,778

 

 

 

 

Total

 

$

61,304

 

 

$

32,526

 

 

$

28,778

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Warrant liabilities

 

$

450

 

 

$

 

 

$

 

 

$

450

 

Total

 

$

450

 

 

$

 

 

$

 

 

$

450

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair Value Measurement at

December 31, 2018

 

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)

 

$

13,264

 

 

$

13,264

 

 

$

 

 

$

 

Fixed income securities

 

 

49,718

 

 

 

 

 

 

49,718

 

 

 

 

Total

 

$

62,982

 

 

$

13,264

 

 

$

49,718

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Warrant liabilities

 

$

8,511

 

 

$

 

 

$

 

 

$

8,511

 

Total

 

$

8,511

 

 

$

 

 

$

 

 

$

8,511

 

(1)

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



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, corporate bonds and fixed incomeUnited States treasury 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, 20172019 (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

 

 

 

November Private

Placement Warrants

 

Balance at December 31, 2017

 

$

13,128

 

     Change in fair value

 

 

(4,617

)

Balance at December 31, 2018

 

 

8,511

 

     Change in fair value

 

 

(8,061

)

Balance at September 30, 2019

 

$

450

 

 


6. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

Accrued expenses as of September 30, 20172019 and December 31, 20162018 consisted of the following (in thousands):

 

September 30,

 

 

December 31,

 

 

September 30,

 

 

December 31,

 

 

2017

 

 

2016

 

 

2019

 

 

2018

 

Clinical

 

$

1,159

 

 

$

738

 

 

$

1,032

 

 

$

941

 

Compensation and benefits

 

 

750

 

 

 

901

 

 

 

526

 

 

 

830

 

Accounting and legal

 

 

281

 

 

 

279

 

 

 

238

 

 

 

227

 

Other

 

 

122

 

 

 

64

 

 

 

202

 

 

 

369

 

Total accrued expenses

 

$

2,312

 

 

$

1,982

 

Total accrued expenses and other current liabilities

 

$

1,998

 

 

$

2,367

 

 

 

 

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.

WarrantsWARRANTS

In connection with the amendment and restatement of a license agreement with BioHEP Technologies Ltd. (“BioHEP”) in February 2016, the Company issued a warrant to purchase 125,000 shares of the Company’s common stock to BioHEP (the “BioHEP Warrant”), effective February. The BioHEP Warrant had an exercise price of $16.00 per share and expired unexercised on August 1, 2016.2018. 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 ScholesBlack-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 freerisk-free interest 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 ScholesBlack-Scholes pricing model based on the following assumptions: an expected term of 4.99 years; expected stock price volatility of 87%; a risk freerisk-free interest 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 ScholesBlack-Scholes pricing model based on the following assumptions: an expected term of 4.92 years; expected stock price volatility of 87%; a risk freerisk-free interest rate of 1.23%; and a dividend yield of 0%. The aggregate fair value of the IPO Warrants was approximately $0.2 million.

TheIn November 2016, the Company received approximately $5.3 million in proceeds uponentered into a definitive agreement with respect to the exerciseprivate placement of warrants to purchase 641,7431,644,737 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 outstandingand 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(the “November 2016 Private Placement Warrants”) to a group of accredited investors. These investors paid $9.12 for each share of common stock and warrant to purchase one share of common stock. The November 2016 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 ScholesBlack-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 September 30, 2019 and December 31, 2016 and September 30, 2017,2018, the fair value of the November 2016 Private Placement Warrants was approximately $6.3$0.5 million and $17.8$8.5 million, respectively (see Note 5).


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

 

 

September 30,

2019

 

 

December 31, 

2018

 

Risk-free interest rate

 

 

1.6

%

 

 

2.5

%

Expected term (in years)

 

 

2.1

 

 

 

2.9

 

Expected volatility

 

 

62.3

%

 

 

78.1

%

Expected dividend yield

 

 

0

%

 

 

0

%

In September 2019, the Company entered into a Loan and Security Agreement (the “Loan and Security Agreement”) with Pontifax Medison Finance (Israel) L.P. and Pontifax Medison Finance (Cayman) L.P., as lenders, and Pontifax Medison Finance GP, L.P., in its capacity as administrative agent and collateral agent for itself and the lenders, providing for a $20.0 million term loan (see Note 9). In connection with the Company’s Loan and Security Agreement, the Company issued to certain lenders warrants to purchase 250,000 shares of common stock (the “Pontifax Warrants”). The Pontifax Warrants are exercisable at an exercise price of $6.57 per share and expire on September 19, 2025. The Company evaluated the terms of the Pontifax Warrants and concluded that they are equity-classified. The fair value of the Pontifax Warrants was estimated on the issuance date using a Black-Scholes pricing model based on the following assumptions: an expected term of 6.0 years; expected stock price volatility of 83.2%; a risk-free interest rate of 1.7%; and a dividend yield of 0%. The aggregate fair value of the Pontifax Warrants was approximately $0.6 million and was recorded as a discount to the term loan and will be amortized over the life of the term loan using the effective interest rate method.

In September 2019, the Company issued warrants to a service provider to purchase 15,000 shares of common stock (the “September 2019 Warrants”). The September 2019 Warrants are exercisable at an exercise price of $4.21 per share and expire on September 19, 2021. The Company evaluated the terms of the September 2019 Warrants and concluded that they are equity-classified. The fair value of the September 2019 Warrants was estimated on the applicable issuance date using a Black-Scholes pricing model based on the following assumptions: an expected term of 2.0 years; expected stock price volatility of 69.4%; a risk-free interest rate of 1.7%; and a dividend yield of 0%. The aggregate fair value of the September 2019 Warrants was approximately $19,000 and will be expensed over the life of the service contract.

 

 

 

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 summarizesA summary of the warrant activity for the year ended December 31, 2016 and for the nine months ended September 30, 2017:2019 and for the year ended December 31, 2018 is as follows:

 

 

 

Warrants

 

Outstanding at December 31, 20152017

 

 

1,181,776

     Grants

1,798,084

     Exercises

(641,743

)

     Expirations/cancellations

(540,033

)

Outstanding at December 31, 2016

1,798,0841,787,124

 

     Grants

 

 

 

     Exercises

 

 

 

     Expirations/cancellations

 

 

(125,000

)

Outstanding at December 31, 2018

1,662,124

     Grants

265,000

     Exercises

     Expirations/cancellations

 

Outstanding at September 30, 20172019

 

 

1,798,0841,927,124

 

 

8. STOCKHOLDERS’ EQUITY

Common and Preferred Stock

In August 2017, the Company entered into a Controlled Equity OfferingSM Sales 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 pays Cantor a commission rate equal to 3.0% of the aggregate gross proceeds from each sale. During the year ended December 31, 2018, the Company sold an aggregate of 217,329 shares of its common stock pursuant to the Sales Agreement at a weighted-average selling price of $15.42 per share, which resulted in $3.2 million of net proceeds to the Company.


In August 2018, the Company issued and sold in an underwritten public offering an aggregate of 3,246,079 shares of its common stock at $12.50 per share, which included 246,079 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 $38.0 million of net proceeds, after deducting underwriting discounts and commissions and other offering expenses payable by the Company.

2014 Stock Incentive Plan and 2015 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 Company’s Board of Directors initially adopted the 2015 Plan providesin December 2015, subject to stockholder approval, and authorized 750,000 shares of Common Stock to be issued under the 2015 Plan. The 2014 Plan and 2015 Plan provide 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

Amended and Restated 2015 Stock Incentive Plan

In June 2018, upon receipt of shares reserved for issuance understockholder approval at the Company’s 2018 annual meeting, the 2015 Plan iswas amended and restated in its entirety increasing 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) theauthorized number of shares of common stock subjectreserved for issuance by 800,000 shares (together with the 2014 Plan, the 2015 Plan, the “Stock Incentive Plans”). The Board approved the Amended and Restated 2015 Plan on March 9, 2018. Pursuant to the Amended and Restated 2015 Plan, there are 1,666,863 shares authorized for issuance. In addition, to the extent any outstanding awards under the 2014 Plan that expire, terminate or are otherwise surrendered, cancelled or forfeited. forfeited after the closing of the Company’s IPO, those shares are added to the authorized shares under the Amended and Restated 2015 Plan. The total amount of shares authorized for issuance under both the 2014 Plan and the Amended and Restated 2015 Plan is 2,300,000. As of September 30, 2019, the Company had 339,644 shares available for issuance under the Amended and Restated 2015 Plan.

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 PlanStock Incentive Plans 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.There were no stock options granted prior to 2015.

The following table summarizes the option activity under the Stock Incentive Plans for the nine months ended September 30, 2017, under the 2014 Plan2019 and the 2015 Plan (collectively the “Plans”):

year ended December 31, 2018:

 

Options

 

 

Weighted-Average

Exercise Price

Per Share

 

 

Aggregate

Intrinsic

Value

 

 

Options

 

 

Weighted-Average

Exercise Price

Per Share

 

 

Aggregate

Intrinsic

Value

 

Options outstanding at December 31, 2015

 

 

610,481

 

 

$

11.99

 

 

$

 

Options outstanding at December 31, 2017

 

 

988,565

 

 

$

10.83

 

 

$

2,617,859

 

Granted

 

 

128,334

 

 

 

10.41

 

 

 

 

 

 

311,000

 

 

 

12.28

 

 

 

 

Exercised

 

 

(10,247

)

 

 

9.28

 

 

 

29,550

 

 

 

 

 

 

 

 

 

 

Cancelled

 

 

(24,253

)

 

 

9.89

 

 

 

 

 

 

 

 

 

 

 

 

 

Outstanding at December 31, 2016

 

 

704,315

 

 

$

11.82

 

 

 

 

Outstanding at December 31, 2018

 

 

1,299,565

 

 

 

11.18

 

 

 

881,385

 

Granted

 

 

286,500

 

 

 

8.20

 

 

 

 

 

 

395,500

 

 

 

9.61

 

 

 

 

Exercised

 

 

(10,000

)

 

 

9.28

 

 

 

11,228

 

 

 

 

 

 

 

 

 

 

Cancelled

 

 

(3,250

)

 

 

12.44

 

 

 

 

 

 

(22,750

)

 

 

13.36

 

 

 

 

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

 

Options outstanding at September 30, 2019

 

 

1,672,315

 

 

$

10.78

 

 

$

 

Options exercisable at September 30, 2019

 

 

1,016,449

 

 

$

11.23

 

 

$

 

 

As of September 30, 2017,2019, all options granted are expected to vest and theoutstanding have a weighted-average remaining contractual life of all options is 8.47.5 years. The weighted-average fair value of all stock options granted for the nine months ended September 30, 20172019 was $5.67.$6.74. Intrinsic value at September 30, 20172019 and December 31, 2018 is based on the closing price of the Company’s common stock on that date of $16.84$3.44 per share.share and $10.39 per share, respectively.

Prior toIn January 2018, the Company’s IPO on May 11, 2016,Company issued a stock option award as an inducement grant for the Board determined the estimated fair valuepurchase of an aggregate of 50,000 shares 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 valueoutside of the Stock Incentive Plans, at an exercise price of $12.02 per share. In February 2019, the Company issued a stock option award as an inducement grant for the purchase of an aggregate of 40,000 shares of the Company’s


common stock, on the dateoutside of the grant is based on the closingStock Incentive Plans, at an exercise price of $10.39 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 thatshare. These inducement grants 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 ofexcluded from the option grants on the grant date of the option. The Company accounts for stock option forfeitures when they occur.activity table above.

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 2017during the nine months ended September 30, 2019 and 20162018 are as follows, presented on a weighted-average basis.basis:

 

Nine Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

2017

 

 

2016

 

 

2019

 

 

2018

 

Risk-free interest rate

 

 

2.0

%

 

 

1.4

%

 

 

2.5

%

 

 

2.5

%

Expected term (in years)

 

 

6.0

 

 

 

6.1

 

 

 

5.9

 

 

 

6.1

 

Expected volatility

 

 

79.8

%

 

 

77.6

%

 

 

81.1

%

 

 

82.5

%

Expected dividend yield

 

 

0

%

 

 

0

%

 

 

0

%

 

 

0

%

Performance-Based Restricted Stock Units

In January 2019, the Company issued RSUs to senior management under the 2015 Plan that represent shares potentially issuable in the future subject to the satisfaction of certain performance milestones as well as a service condition. The vesting of 50% of the RSUs is based upon the Company’s performance relative to a peer group over a two-year performance period, from January 1, 2019 through December 31, 2020, measured by the Company’s relative total shareholder return. The vesting of 25% of the RSUs is based on the achievement of a performance goal milestone as of December 31, 2019 and the vesting of the remaining 25% of the RSUs is based upon the achievement of a performance goal milestone as of December 31, 2020.

The Company estimates the fair value of total shareholder return RSUs at the date of grant using a Monte Carlo valuation methodology and amortizes those fair values over the requisite service period for each separately vesting tranche of the award. The Monte Carlo methodology that the Company uses to estimate the fair value of total shareholder return RSUs at the date of grant incorporates into the valuation the possibility that the market condition may not be satisfied. Provided that the requisite service is rendered, the total fair value of the total shareholder return RSUs at the date of grant must be recognized as compensation expense even if the market condition is not achieved. However, the number of shares that ultimately vest can vary significantly with the performance of the specified market criteria.

The Company estimates the fair value of milestone-based RSUs at the date of grant using the fair value method and the probability that the specified performance criteria will be met. Each quarter the Company updates its assessment of the probability that the specified milestone criteria will be achieved and adjusts its estimate of the fair value, if necessary. The Company amortizes the fair values of milestone-based RSUs over the requisite service period for each separately vesting tranche of the award. As of September 30, 2019, the Company estimates that it is currently not probable that it will achieve the December 31, 2019 clinical milestone applicable to the milestone-based RSUs and has not recognized stock-based compensation expense for these RSUs as it relates to the December 31, 2019 milestone base goal. As of September 30, 2019, the Company estimates that it is currently probable that it will achieve the December 31, 2020 clinical milestone applicable to the milestone-based RSUs and has recognized the stock-based compensation expense for these RSUs as it relates to the December 31, 2020 milestone.

The total stock-based compensation recognized for the three and nine months ended September 30, 2019 for the RSUs was approximately $0.1 million and $0.4 million, respectively. As of September 30, 2019, the Company adjusted stock-based compensation approximately $0.1 million for previously recognized stock-based compensation for the December 31, 2019 clinical milestone currently estimated to be not probable.

The following table is a rollforward of RSU activity under the Stock Incentive Plans for the nine months ended September 30, 2019:

 

 

Restricted

Stock Units

 

 

Weighted-Average

Grant Date

Fair Value

 

Total nonvested units at December 31, 2018

 

 

 

 

$

 

     Granted

 

 

203,700

 

 

 

8.49

 

     Exercised

 

 

 

 

 

 

     Vested

 

 

 

 

 

 

     Cancelled

 

 

(17,900

)

 

 

8.49

 

Total nonvested units at September 30, 2019

 

 

185,800

 

 

$

8.49

 

The assumptions used to determine the fair value of the RSUs granted to management during the nine months ended September 30, 2019 for the performance goal milestone units is based on the market price of the award on the grant date, which was a weighted


average fair value for the nine months ended September 30, 2019 of $10.35 per share. The fair value of the performance-based RSUs granted to management in 2019 for the Company’s relative total share return units is based on the Monte Carlo Simulation method on the grant date, which the weighted average fair value as of the nine months ended September 30, 2019 was $6.62 per share.

Stock-Based Compensation

The following table summarizes the Company’s stock-based compensation expense for the three and nine months ended September 30, 20172019 and 2016, under the Plans2018 (in thousands):

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

Stock-based compensation:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Research and development

 

$

121

 

 

$

104

 

 

$

402

 

 

$

286

 

 

$

314

 

 

$

214

 

 

$

971

 

 

$

628

 

General and administrative

 

 

389

 

 

 

274

 

 

 

1,081

 

 

 

729

 

 

 

497

 

 

 

499

 

 

 

1,854

 

 

 

1,434

 

Total Stock-based compensation

 

$

510

 

 

$

378

 

 

$

1,483

 

 

$

1,015

 

 

$

811

 

 

$

713

 

 

$

2,825

 

 

$

2,062

 

 

The fair value of stock options vested during the nine months ended September 30, 20172019 was $1,275,000.$2.4 million. At September 30, 2017,2019, there was $3,875,000$4.6 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 2.32.6 years.

The expense recognized is partially dependent upon the Company’s estimate of the number of shares that will ultimately be issued. At September 30, 2019, there was $0.7 million of unrecognized stock-based compensation expense relating to performance-based RSUs granted pursuant to the Stock Incentive Plans, which will be recognized over the weighted-average remaining vesting period of 1.3 years.

Reserved Shares

As of September 30, 20172019 and 2016,December 31, 2018, the Company has reserved the following shares of common stock for potential conversionissuance of theshares resulting from exercise of outstanding warrants, convertible shares from the Loan and outstandingSecurity Agreement, options and performance-based RSUs, as well as issuance of shares available for grant under the 2015 Plan:

Stock Incentive Plans:

 

 

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

 

 

 

September 30,

 

 

December 31,

 

 

 

2019

 

 

2018

 

IPO warrants

 

 

28,347

 

 

 

28,347

 

November private placement warrants

 

 

1,633,777

 

 

 

1,633,777

 

Loan and security agreement

 

 

2,329,143

 

 

 

 

Pontifax warrants

 

 

250,000

 

 

 

 

September 2019 warrants

 

 

15,000

 

 

 

 

2015 amended and restated stock incentive plan

 

 

2,197,759

 

 

 

2,238,887

 

Inducement awards

 

 

90,000

 

 

 

50,000

 

Total

 

 

6,544,026

 

 

 

3,951,011

 

 

8. COMMITMENTS AND CONTINGENCIES

Leases9. CONVERTIBLE DEBT

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,September 2019, the Company entered into a newLoan and Security Agreement with Pontifax Medison Finance (Israel) L.P. and Pontifax Medison Finance (Cayman) L.P., as lenders, and Pontifax Medison Finance GP, L.P., in its capacity as administrative agent and collateral agent for itself and the lenders (collectively, the “Lenders”), providing for a $20.0 million term loan (the “Convertible Term Loan”), which the Company received on September 19, 2019 (the “Closing Date”). The Convertible Term Loan bears interest at an annual rate of 8.0%. The Loan and Security Agreement provides for interest-only payments for twenty-four months and repayment of the aggregate outstanding principal balance of the Convertible Term Loan in quarterly installments starting upon expiration of the interest only period and continuing through September 19, 2023 (the “Maturity Date”). The Company incurred issuance costs of $0.4 million. The Convertible Term Loan issuance costs are shown as an offset to the Convertible Term Loan on the balance sheet and are amortized using the effective interest method to interest expense through the Maturity Date.

The Company may, at its option, prepay some or all of the then outstanding principal balance and all accrued and unpaid interest on the Convertible Term Loan, together with a prepayment charge equal to 3% of the principal amount being prepaid. The Lenders may, at their option, elect to convert the then outstanding Convertible Term Loan amount and all accrued and unpaid interest thereon into shares of the Company’s common stock at a conversion price of $8.76 per share, which is equal to two times the weighted average closing price of the Company’s common stock during the 30 trading days prior to the execution of the Loan and Security Agreement (the “30-day VWAP”).


The Company’s obligations are secured by a security interest, senior to any current and future debts and to any security interest, in all of the Company’s right, title, and interest in, to and under all of its property and other assets, subject to limited exceptions including the Company’s intellectual property. The Loan and Security Agreement contains customary events of default, representations, warranties and covenants, including a material adverse effect clause. The Company must maintain a minimum cash balance of $7.0 million in Spring Bank Pharmaceuticals, Inc. accounts, or it is in breach of the Loan and Security Agreement, which the Company is in compliance with as of September 30, 2019.

Upon the occurrence of an event of default, a default interest rate of an additional 4% per annum may be applied to the outstanding loan balances, and the Lenders may declare all outstanding obligations immediately due and payable and exercise all of its rights and remedies as set forth in the Loan and Security Agreement and under applicable law.

In addition, the Company issued the Lenders warrants to purchase an aggregate of 250,000 shares of the Company’s common stock. The Pontifax Warrants are exercisable for a period of six years from the Closing Date at an exercise price of $6.57 per share, which is equal to 1.5 times 30-day VWAP. The aggregate fair value of the Pontifax Warrants was approximately $0.6 million and was recorded as a discount to the term loan and will be amortized over the life of the term loan using the effective interest rate method (see Note 7).

During the three and nine months ended September 30, 2019, the Company recorded interest expense of approximately $63,000 in connection with the Convertible Term Loan. The fair value of the term loan as of September 30, 2019 approximates its face value given the close proximity of the execution to September 30, 2019 and due to market terms.

The Company evaluated the accounting for the Loan and Security Agreement and identified an embedded derivative related to the contingent interest feature. The Company determined the fair value of the contingent interest feature to be di minimis and will re-value the derivative at the end of each reporting period.

The following table summarizes the Company’s future principal debt payments on the Convertible Term Loan as of September 30, 2019 (in thousands):

 

 

September 30,

2019

 

2019

 

$

 

2020

 

 

 

2021

 

 

2,500

 

2022

 

 

10,000

 

2023

 

 

7,500

 

Total principal payments

$

20,000

 

     Less: unamortized debt discount

 

 

(989

)

Term loan, long-term

 

$

19,011

 

10. LEASES

The Company has operating leases for its principal office and laboratory space and the Company’s former headquarters. The Company’s leases have remaining lease terms of approximately 8.5 years for its principal office and laboratory space, which includes an option to extend the lease for up to 5 years, and approximately 2 years for its former headquarters. The Company’s former headquarters in Hopkinton, Massachusetts with a lease termlocation is subleased through May 31, 2021. The total payments due during the termremainder of the lease are approximately $771,000.term.

Rent paid



Other information related to leases was as follows:

 

 

For the Nine Months Ended September 30,

 

Cash paid for amounts included in the measurement of lease liabilities:

 

2019

 

Operating cash flow from operating leases (in thousands)

 

$

273

 

 

 

 

 

 

Right-of-use assets obtained in exchange for lease obligations:

 

 

 

 

Operating leases (in thousands)

 

$

2,980

 

 

 

 

 

 

Weighted Average Remaining Lease Term

 

 

 

 

Operating leases

 

8.5 years

 

 

 

 

 

 

Weighted Average Discount Rate

 

 

 

 

Operating leases

 

 

8.0

%

Operating lease costs under the leases for the three and nine months ended September 30, 2017 was $59,0002019 were approximately $130,000 and $174,000,$390,000, respectively. Rent paidTotal operating lease costs for the three and nine months ended September 30, 2016 was $56,0002019 were offset by $22,000 and $110,000, respectively.

Future minimum commitments due under all leases at$59,000, respectively, for sublease income and variable lease cost payments. Total rent expense for the three and nine months ended September 30, 2017 are2018 was $144,000 and $286,000 respectively, which included payments for a lease of the Company’s research and development facility. The lease term of the research and development facility ended as of June 30, 2018.

The following table summarizes the Company’s maturities of operating lease liabilities as of September 30, 2019 (in thousands):

Year

 

 

 

 

2019 (excluding the nine months ended September 30, 2019)

 

$

144

 

     2020

 

 

588

 

     2021

 

 

508

 

     2022

 

 

450

 

     2023

 

 

462

 

     Thereafter

 

 

2,405

 

Total lease payments

$

4,557

 

     Less: present value discount

 

 

(1,252

)

Total

 

$

3,305

 

For comparative purposes, the Company’s aggregate future minimum non-cancellable commitments under operating leases as of December 31, 2018 were as follows (in thousands):

 

Year

 

 

 

 

 

 

 

 

2017

 

$

59

 

2018

 

 

174

 

2019

 

 

157

 

 

$

417

 

2020

 

 

164

 

 

 

588

 

2021

 

 

508

 

2022

 

 

450

 

Thereafter

 

 

70

 

 

 

2,867

 

Total minimum lease payments

 

$

624

 

Total minimum lease payments

$

4,830

 

 

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.11. COMMITMENTS AND CONTINGENCIES



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. Milestone and royalty payments associated with the Company’s amended and restated license agreement with BioHEP cannot be reasonably estimated as to whether or when they will occur. As of September 30, 2019, there have been no milestone or royalty payments made to BioHEP.

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.

10.12. 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.

YouThe following information should be read in conjunction with the following discussionunaudited financial information and analysisthe 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, 2018, 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 United States Securities and Exchange Commission, or the SEC, on March 11, 2019.

This report contains forward-looking statements that are being made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, or PSLRA, with the intention of obtaining the benefits of the “safe harbor” provisions of the PSLRA. Forward-looking statements involve risks and uncertainties. In this Quarterly Report on Form 10-Q, words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.

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. We caution our readers that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and resultsliquidity, and the development of operations together with Part I, Item 1“Financial Statements” and related notes included elsewherethe 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.

Overview

We are a clinical-stage biopharmaceutical company engaged in the discovery and development of a novel class of therapeutics for the treatment of viral infections, inflammatory diseases and certain cancers using our proprietary small molecule nucleic acid hybrid, or SMNH, chemistrynucleotide platform. Our SMNHWe design our 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 SMNHlead product candidate, inarigivir soproxil, (formerly known as SB 9200), which we refer to asor inarigivir, for the treatment of certain viral diseases.chronic hepatitis B virus, or HBV. We have designed our antiviral product candidates, including inarigivir, to selectively activate within infected hepatic cells the cellular proteins,protein, 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, mayas a RIG-I agonist, could play an important role in antiviral therapy by modulatingas a result of its dual mechanism of action that is designed to selectively modulate the body’s immune response through its mechanisms of action to fightand inhibit viral infections.replication. We are also developing other SMNHadditional product candidates, including our STING (STimulator of INterferon Genes) agonist product candidate, SB 11285, which is an immunotherapeutic agent for the potential treatment of selected cancers through the activation of the STimulator of INterferon Genes, or STING, pathway.cancers.

RIG-I Product Candidates

WeThe World Health Organization estimates that 257 million people 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 patientschronically infected with chronic HBV using dosesworldwide, and nearly 900,000 people worldwide die every year due to complications from chronic HBV infection despite the availability of 25 mg, 50 mg, 100 mgvaccines against the virus. There is no approved cure for chronic HBV and 200 mg of inarigivir as a monotherapy administered daily for 12 weeks. Following this treatment, all patients will receive treatment with the oralcurrently approved direct-acting 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 compoundstherapies for the treatment of chronic HBV lack a broadly sustained response following the discontinuation of treatment.

We are developing inarigivir, an orally-administered investigational selective immunomodulator, as a potential backbone in a combinatorial treatment for chronic HBV, with different pharmacological mechanisms of action than inarigivir. Pursuanta goal to this strategy,accelerate and substantially increase functional cure rates in 2016, we entered into an agreement with Arrowhead Pharmaceuticals, Inc., or Arrowhead, to collaborate on the study of the combined usea simple, safe and selective manner. We recently completed our global Phase 2 ACHIEVE trial of inarigivir and Arrowhead’s small interfering ribonucleic acid, or siRNA, product pipeline forhave launched two Phase 2 global trials (CATALYST 1 and CATALYST 2) examining the treatmentadministration 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 agreementinarigivir 400mg as monotherapy and co-administered 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 withnucleotide in naïve and virally suppressed 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.HBV patients. We anticipate that Gilead will initiate this clinical trial in the first quarter of 2018.  

presenting initial results from these trials throughout 2020. We are also pursuing the development of theSB 9225, a co-formulation of inarigivir with Viread and with entecavir (marketedtenofovir disoproxil fumarate, or TDF, as Baraclude®), which we refer to as Baraclude, asa potential fixed-dose combination productsproduct for the treatment of patients with chronic HBV who may benefit from the combined use ofHBV. In addition to our inarigivir clinical trials, we continue to explore collaborations, including with siRNA compounds targeting hepatitis B surface antigen, or HBsAg, as a potentialwell as other antiviral and 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.mechanisms. We believe that the immunomodulatory activity provided byof inarigivir could become a key component of a future combinatorial treatment offor patients infected with chronic HBV, which could increaseincreasing the percentage of chronic HBV patients who achieve a functional cure.

STING Agonist Product CandidatesWe entered into a clinical trial supply and collaboration agreement with Gilead Sciences, Inc., or Gilead, which has been subsequently amended, under which Gilead is funding and conducting a Phase 2 clinical trial examining inarigivir (50mg, 200mg and 400mg) co-administered with Vemlidy® 25 mg (tenofovir alafenamide) in patients infected with chronic HBV. In October 2019, we announced interim top-line results at 12 weeks from the first 50mg cohort of this Phase 2 trial. In this trial, 30 patients with HBV


infection received low-dose inarigivir 50mg plus Vemlidy for 12 weeks. At week 12, 7 of the 30 patients were HBsAg responders and met the primary efficacy study endpoint of having greater than or equal to 0.5 log₁₀ IU/mL reduction in HBsAg from baseline. In the inarigivir 50mg monotherapy cohort of the Company’s completed Phase 2 ACHIEVE trial, only 1 of 14 patients was a HBsAg responder at week 12. The co-administration of inarigivir 50mg and Vemlidy was generally safe and well tolerated with no serious adverse events observed over the 12-week treatment period. Treatment-emergent adverse events ranged from mild to moderate in severity. Interim top-line results from the remaining cohorts of this trial are expected in 2020.

We are also developing SB 11285,novel chimeric antisense oligonucleotide compounds, which we refer to as CASOs, for the treatment of HBV. In July 2019, we entered into a novel proprietaryresearch agreement with The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to evaluate our CASOs. We plan to evaluate a triple combination for HBV consisting of the lead CASO co-administered with inarigivir and a nucleo(s)tide analog for potentially achieving functional cure.

In addition to our inarigivir clinical development program, we are also developing a STING program consisting of STING agonists and antagonists. Our lead STING agonist asproduct candidate, SB 11285, is a potential next-generation 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,multiple tumor-derived cell lines, SB 11285 has been observed to cause the induction of interferon and other cytokines consistent with engagement of the target, as well as cell death or apoptosis, of multiple tumor-derived cell lines.

We continue to conductand apoptosis. Based on our preclinical studies ofperformed to date, SB 11285 has reduced tumor volumes, without dose-limiting toxicities, 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 mouserodent tumor 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 ofor intratumorally. These findings lead us to believe that SB 11285 has been observed in the A20 lymphoma model. In addition, in the CT26 colon cancer syngeneic mouse model,potential to be administered clinically by either route of administration, and that 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 11285may be used to target a variety of tumors which could potentiallyat various anatomic sites and, if approved, has the potential to be used in combination with other therapeutic modalities.modalities to enhance efficacy.



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 thatIn June 2019, 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 submitfiled an investigational new drug application or IND, and/orfor a Phase 1 clinical trial application, or CTA, for the intravenously-administered (IV) SB 11285 for the clinical study of advanced solid tumors, which was accepted by the U.S. Food and Drug Administration in mid-2018,July 2019. Part 1 of this Phase 1 trial is a dose-escalation study with IV SB 11285 monotherapy followed by combination with a checkpoint inhibitor and if cleared, commenceis designed to determine a recommended phase 2 dose. Part 2 of this Phase Ib/II clinical trials1 trial will explore IV SB 11285 antitumor activity in liver cancercombination with a checkpoint inhibitor in selected tumor types. The trial will be conducted at multiple sites in the second halfUnited States. We initiated this Phase 1 trial in the third quarter of 2018.2019 and anticipate that top-line results from this trial will be available in 2020.

In July 2019, we presented pre-clinical data from a novel STING antagonist compound, which showed potent inhibition of interferon and pro-inflammatory cytokines in wild type and mutant STING in vitro models. In vivo administration of this compound antagonized STING-agonist-induced interferon and cytokine production in the blood, spleen and liver in mice, illustrating the potential that this compound has for therapeutic applications in interferonopathies, as well as autoimmune and inflammatory diseases. Furthermore, in August 2017,2019, we entered into a preclinical research collaborationagreement with a third partythe University of Texas Southwestern Medical School to examine the potential for the conjugation of selected compounds fromevaluate our small molecule 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 Overviewantagonist compounds.

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. No additional funding remains available to us under any grant for the development of any of our product candidates. We have funded our operations primarily 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.

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, 2017,2019 were $6.9 million and $16.7 million, respectively, and our net losses for the three and nine months ended September 30, 2018 were $8.8 million and $17.4 million, for the year ended December 31, 2016.respectively. As of September 30, 2017,2019, we had an accumulated deficit of $77.8$118.7 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, including our at-the-market offering program with Cantor Fitzgerald & Co., 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, 2017,2019, we had $52.2$63.1 million in cash, cash equivalents and marketable securities. WeBased on our current operating plan, we expect that our cash, cash equivalents and marketable securities as of September 30, 20172019 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.into 2022. See “—Liquidity and Capital Resources.”

Grant revenue

Historically, we have generatedWe do not expect to generate revenue from grants from the NIHproduct sales unless and until we successfully complete development and obtain regulatory approval for theone or more of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. We have no manufacturing facilities, and all of our manufacturing activities are contracted out to third parties. Additionally, we currently utilize third-party contract research organizations, or CROs, to carry out our clinical development of inarigivir. The NIH grants provided funding of $6.8 million between October 2003activities, and April 2016. As of September 30, 2017, no additional funding remains available to us under any grantwe do not yet have a sales organization. If we obtain regulatory approval for the development of any of our product candidates.candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, we will seek to continue to fund our operations through public or private equity or debt financings or other sources including geographic partnerships. However, we may be unable to raise additional funds or enter into other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial condition and our ability to develop our products.

Recent Developments

In September 2019, we entered into a loan and security agreement with certain affiliates of Pontifax Medison Finance that provides for a $20.0 million term loan and bears annual interest at a rate of 8.0%, which we refer to as the Loan and Security Agreement. The lenders may, at their option, elect to convert some or all of the then outstanding term loan amount and all accrued and unpaid interest thereon into shares of our common stock at a conversion price of $8.76 per share. The Loan and Security Agreement contains customary events of default, representations, warranties and covenants. The Loan and Security Agreement is described further in Note 9 to the notes to the consolidated financial statements contained in this Quarterly Report on Form 10-Q.

Financial Operations Overview

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 ofdirect research and development since inceptionexpenses are not currently tracked on a program-by-program basis. Our primary focus has been on the research and 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 discoveryresearch 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 theseany of our 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-enablinginvestigational new drug, or IND, application 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

if a product is approved, a continued acceptable safety profile of the products following approval.product.

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 our business model. 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-stage clinical trials. We expect that our research and development expenses will continue to increase in the foreseeable future as we continueinitiate clinical trials for certain product candidates and pursue later stages of clinical development of ourother product candidates. However, we do not believe that it is possible at this time to accurately project total program-specific expenses through commercialization. There are numerous factors associated with the successful commercialization of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. Additionally, future commercial and regulatory factors beyond our control will impact our clinical development programs and plans.

General and administrative

General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in our executive, finance, corporate and business development and administrative functions. General and administrative expenses also include legal fees relating to patent and corporate matters; professional fees for accounting, auditing, tax 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 anticipate 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 development activities and the potential commercialization of our product candidates. We also expect to continue to incur significantincreased expenses associated with being a 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,premiums, and investor and public relations costs.

Other income (expense)

Other income (expense) consists of interest income earned on our cash, cash equivalents, restricted cash and marketable securities and the gain/loss onsecurities.


Change in fair value of warrant liabilities

Change in fair value of warrant liabilities consists of a gain or (loss) related to the change in the fair value of the warrant liabilities.warrants issued in connection with our private placement offering in November 2016, resulting from a change factors such as a change in our stock price and a change in expected stock price volatility.

Critical Accounting Policies and Significant Judgments and Estimates

Our consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States of America. The preparation of our consolidated financial statements and related disclosures requires us 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 involved in the accounting policies described therein may have 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.

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.


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 Warrants

In connection with entering into the amended and restated license agreement with BioHEP effective February 1, Issued in 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 terms of the warrant and concluded that it should be equity-classified. The fair value of the warrant, $0.8 million 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 shares 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. The aggregate fair value of the IPO warrants was $0.2 million.  See Note 7 of the notes to the unaudited financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Liability-Classified WarrantsPrivate Placement

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, which we refer to a group of accredited investors. Theas the November 2016 Warrants. These warrants will beare exercisable beginning May 24, 2017 at an exercise price of $10.79 per share. We evaluated the terms of thethese warrants and concluded that they should be liability-classified. In November 2016, we recorded the fair value of these warrants of approximately $8.3 million. We recognize any change in the value of the warrant liability each reporting period in the statement of operations. As of September 30, 2017,2019, the fair value of the warrants was approximately $17.8$0.5 million, which is an increasea decrease of $11.5$8.0 million from the fair value of approximately $6.3$8.5 million as of December 31, 2016.2018. 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 issue stock-based awards to employees and non-employees, generally in the form of stock options or performance-based restricted stock units. We account for our stock-based compensation awards in accordance with Financial Accounting Standards Board, (FASB) ASC Topic 718, Compensation—Stock Compensation, or ASC 718. ASC 718 requires all stock-based payments to employees, including grants of employee stock options and modifications to existing stock awards, to be recognized in the statements of operations and comprehensive loss based on their fair values. We adopted ASU 2018-07, Improvements to Nonemployee Share-Based Payment Accounting, effective July 1, 2018, which aligns the accounting treatment of nonemployee awards with employee awards. Described below is the methodology we have utilized in measuring stock-based compensation expense. Stock option, common stock and restricted stock values are determined based on a blend of our stock price and the quoted market price of our comparable public companies.

We measure stock options and other stock-based awards granted to employees, nonemployees and directors based on the fair value on the date of grant and recognize the corresponding compensation expense of those awards, net of estimated forfeitures, over the requisite service period, which is generally the vesting period of the respective award. We account for forfeitures as they occur. Generally, we issue stock options and performance based restricted stock awardsunits with only service-based vesting conditions and record the expense for these awards using the straight-line method.

We measure stock options Each quarter we update our assessment of the probability that the specified performance criteria will be achieved and other stock-based awards granted to consultants and nonemployees based onadjust our estimate of the fair value of the award on the date at which the related service is complete. We recognize this 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.performance-based RSUs if necessary.

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, The assumptions we began issuingused to determine the fair value of granted stock options to employees, directors and consultants. During the periodsin nine months ended September 30, 20172019 and 2016, we issued common stock2018 are as follows:

 

 

For the Nine Months Ended September 30,

 

 

 

2019

 

 

2018

 

Risk-free interest rate

 

 

2.5

%

 

 

2.5

%

Expected term (in years)

 

 

5.9

 

 

 

6.1

 

Expected volatility

 

 

81.1

%

 

 

82.5

%

Expected dividend yield

 

 

0

%

 

 

0

%

The assumptions used to consultants and advisors as compensation for services and recognized expense equal todetermine the fair value of the shares issued. performance-based restricted stock units granted to management during the nine months ended September 30, 2019 for the performance goal milestone units is based on the market price of the award on the grant date, which was a weighted average fair value for the nine months ended September 30, 2019 of $10.35 per share. The fair value of the performance-based restricted stock units granted to management in 2019 for the Company’s relative total share return units is based on the Monte Carlo Simulation method on the grant date, which the weighted average fair value as of the nine months ended September 30, 2019 was $6.62 per share.

These assumptions represented our best estimates, but the estimates involve inherent uncertainties and the application of our judgment. As a result, if factors change and we use significantly different assumptions or estimates, our stock-based compensation expense could be materially different. We recognize compensation expense for only the portion of awards that are expected to vest.

We expect the impact of our stock-based compensation expense for stock options and performance based restricted stock units granted to employees and non-employees to grow in future periods due to the potential increases in the fair value of our common stock and the increase in the number of grants as a result of an increase in headcount.


The following table summarizes the classification of our stock-based compensation expenses recognized in our consolidated statements of operations and comprehensive loss (in thousands):

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

Stock-based compensation:

 

2019

 

 

2018

 

 

2019

 

 

2018

 

     Research and development

 

$

314

 

 

$

214

 

 

$

971

 

 

$

628

 

     General and administrative

 

 

497

 

 

 

499

 

 

 

1,854

 

 

 

1,434

 

Total Stock-based compensation

 

$

811

 

 

$

713

 

 

$

2,825

 

 

$

2,062

 

 

 

 

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, 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 year in which we have total annual gross revenues of approximately $1.07 billion or more; the last day of the fiscal year following the fifth anniversary of the date of the completion of the closing of an IPO;our IPO, which is December 31, 2021; the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or the date on which we are deemed to be a large accelerated filer under the rules of the Securities and Exchange Commission, or the SEC.

Results of Operations

Comparison of the Three and Nine Months Ended September 30, 20172019 and 20162018

The following table summarizes our results of operations for the three and nine months ended September 30, 20172019 and 20162018 (in thousands):

 

 

For the Three Months Ended September 30,

 

 

 

 

 

 

For the Nine Months Ended September 30,

 

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

 

 

2019

 

 

2018

 

 

Change

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

5,228

 

 

$

5,656

 

 

$

(428

)

 

$

18,070

 

 

$

15,188

 

 

$

2,882

 

General and administrative

 

 

2,247

 

 

 

2,059

 

 

 

188

 

 

 

7,547

 

 

 

6,681

 

 

 

866

 

           Total operating expenses

 

 

7,475

 

 

 

7,715

 

 

 

(240

)

 

 

25,617

 

 

 

21,869

 

 

 

3,748

 

Loss from operations

 

 

(7,475

)

 

 

(7,715

)

 

 

240

 

 

 

(25,617

)

 

 

(21,869

)

 

 

(3,748

)

Other income(expense)

 

 

208

 

 

 

271

 

 

 

(63

)

 

 

894

 

 

 

603

 

 

 

291

 

Change in fair value of warrant liabilities

 

 

355

 

 

 

(1,336

)

 

 

1,691

 

 

 

8,061

 

 

 

3,837

 

 

 

4,224

 

Net loss

 

$

(6,912

)

 

$

(8,780

)

 

$

1,868

 

 

$

(16,662

)

 

$

(17,429

)

 

$

767

 

 

 

 

For the Three Months Ended September 30,

 

 

Increase

 

 

For the Nine Months Ended September 30,

 

 

Increase

 

 

 

2017

 

 

2016

 

 

(Decrease)

 

 

2017

 

 

2016

 

 

(Decrease)

 

Grant revenue

 

$

 

 

$

 

 

$

 

 

$

 

 

$

352

 

 

$

(352

)

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

3,221

 

 

 

2,723

 

 

 

498

 

 

 

9,152

 

 

 

11,247

 

 

 

(2,095

)

General and administrative

 

 

1,968

 

 

 

1,452

 

 

 

516

 

 

 

5,811

 

 

 

4,136

 

 

 

1,675

 

           Total operating expenses

 

 

5,189

 

 

 

4,175

 

 

 

1,014

 

 

 

14,963

 

 

 

15,383

 

 

 

(420

)

Loss from operations

 

 

(5,189

)

 

 

(4,175

)

 

 

(1,014

)

 

 

(14,963

)

 

 

(15,031

)

 

 

68

 

Other income

 

 

141

 

 

 

27

 

 

 

114

 

 

 

220

 

 

 

65

 

 

 

155

 

Change in fair value of warrant liabilities

 

 

(5,780

)

 

 

 

 

 

(5,780

)

 

 

(11,474

)

 

 

 

 

 

(11,474

)

Net loss

 

$

(10,828

)

 

$

(4,148

)

 

$

(6,680

)

 

$

(26,217

)

 

$

(14,966

)

 

$

(11,251

)


Grant revenue. There was no grant revenue for the three months ended September 2017 and 2016. There was no grant revenue for the nine months ended September 30, 2017 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 million forduring the three months ended September 30, 2017, compared to $2.72019 and 2018 were $5.2 million forand $5.7 million, respectively. The decrease of $0.5 million during the three months ended September 30, 2016.2019 was primarily due to a decrease in spending on preclinical studies and clinical trial-related activities for inarigivir and SB 11285 of $0.7 million and an increase in other research and development related expenses of $0.2 million, including laboratory supplies and non-cash charges for stock-based compensation.


Research and development expenses during the nine months ended September 30, 2019 and 2018 were $18.1 million and $15.2 million, respectively. The increase of $0.5$2.9 million during the nine months ended September 30, 2019 was primarily due primarily to an increase in spending on preclinical studies and clinical trial relatedtrial-related activities for inarigivir and preclinical studies for SB 11285 in the three months ended September 30, 2017.

Research and development expenses were $9.1of $1.6 million, for the nine months ended September 30, 2017, 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 research and development headcount in the nine months ended September 30, 2017. of $0.5 million and other research and development related expenses of $0.8 million including laboratory supplies, lease-related costs, non-cash charges for stock-based compensation and non-cash charges for depreciation.

General and administrative expenses.

General and administrative expenses were $2.0 million forduring the three months ended September 30, 2017, compared to $1.52019 and 2018 were $2.2 million forand $2.1 million, respectively. The increase of $0.1 million during the three months ended September 30, 2016. This2019 was primarily due to an increase in other general and administrative related expenses of $0.1 million, including consulting-related costs and public company related costs, offset by salaries and benefits and legal-related costs.

General and administrative expenses during the nine months ended September 30, 2019 and 2018 were $7.5 million and $6.7 million, respectively. The increase of $0.5$0.8 million during the nine months ended September 30, 2019 was primarily due to an increase in non-cash charges for stock basedstock-based compensation of $0.1$0.4 million additional salaries and benefits of $0.1 million associated with higher headcount of non-research and development employees in the three months ended September 30, 2017, an increase of $0.1 million for public company related expenses in the three months ended September 30, 2017, an increase of $0.1 million for consulting 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 administrativerelated 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, additionalincluding 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 forlegal-related costs, public company related expenses incurred during the nine months ended September 30, 2017costs and $0.1 million for additional rent expense for the nine months ended September 30, 2017;consulting-related costs, offset by a decrease of $0.1 million for legal and consulting related costs during the nine months ended September 30, 2017.lease-related costs.

Other incomeincome(expense). Other income forincome(expense) during the three and nine months ended September 30, 2017 and 20162019 is solely comprised of interest income.income, offset by interest expense. Interest income forduring the three and nine months ended September 30, 20172019 was $141,000$0.3 million and $220,000,$1.0 million, respectively, and was primarily relateddue to the interest earned on marketable securities. Interest income forexpense during the three and nine months ended September 30, 20162019 was $27,000$0.1 million and $65,000,was due to the interest expense incurred on the Convertible Term Loan. Other income(expense) during the three and nine months ended September 30, 2018 was comprised solely of interest income of $0.3 million and $0.6 million, respectively, and was primarily relateddue to the interest earned on marketable securities. The increase in interest income during the three and nine months ended September 30, 2019 was due to a higher average balance of marketable securities.

Change in fair value of warrant liabilities. ChangeThe 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, 2016.2019 was a gain of $0.4 million and $8.1 million, respectively. The change in fair value of warrant liabilities during the three and nine months ended September 30, 2018 was a loss of $1.3 million and a gain $3.8 million, respectively. The change in value each period was solely due to the change in the fair value of the November 2016 Warrants, primarily as a result of the change in our stock price and stock price volatility.

Liquidity and Capital Resources

Sources of Liquidity

From our inception through September 30, 2017,2019, we have financed our operations through proceeds received from private placements of convertible notes, common stock and/or warrants;warrants, the exercise of options and warrants;warrants, NIH grant funding;funding and public offerings of securities. As of September 30, 2017,2019, we had cash, cash equivalents and marketable securities totaling $52.2$63.1 million and an accumulated deficit of $77.8$118.7 million.

 



In August 2017, we entered into a Controlled Equity OfferingSM 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 beare 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, orwhich we refer to as the S-3 Registration Statement, and a prospectus supplement and accompanying base prospectus that we filed with the SECSecurities and Exchange Commission on August 18, 2017.During the year ended December 31, 2018, we sold an aggregate of 217,329 shares of our common stock under the Sales Agreement at a weighted average selling price of $15.42 per share, which resulted in $3.2 million of net proceeds.

 

In June 2017,August 2018, we issued and sold in an underwritten public offering an aggregate of 3,269,2193,246,079 shares of our common stock at $13.00$12.50 per share, which included 384,604246,079 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 theour S-3 Registration Statement. Statement and a prospectus supplement and base prospectus filed on August 9, 2018. The offering resulted in $39.6$38.0 million of net proceeds, after deducting underwriting discounts and commissions and other offering expenses payable by us.


In November 2016,September 2019, we entered into the Loan and Security Agreement that provides for a definitive agreement with$20.0 million term loan and bears annual interest at a grouprate of accredited investors resulting8.0%. The Loan and Security Agreement provides for interest-only payments for twenty-four months and repayment of the aggregate outstanding principal balance of the term loan in a private placementquarterly installments starting upon expiration of 1,644,737the interest only period and continuing through September 19, 2023. The lenders may, at their option, elect to convert some or all of the then outstanding term loan amount and all accrued and unpaid interest thereon into 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 ofCompany’s common stock at a conversion price to the public of $12.00$8.76 per share, which included 24,900 shares pursuantis equal to two times the weighted average closing price of the Company’s common stock during the 30 trading days prior to the exerciseexecution of an option to purchase additional shares grantedthe Loan and Security Agreement. The Loan and Security Agreement contains customary affirmative and negative covenants and events of default. The Loan and Security Agreement is described in Note 9 to the underwritersnotes to the condensed consolidated financial statements contained 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.this Quarterly Report on Form 10-Q.

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,

 

 

For the Nine Months Ended

September 30,

 

 

2017

 

 

2016

 

 

2019

 

 

2018

 

Net cash used in operating activities

 

$

(12,640

)

 

$

(11,708

)

 

$

(20,471

)

 

$

(18,357

)

Net cash used in investing activities

 

 

(19,919

)

 

 

(1,955

)

Net cash provided by (used in) investing activities

 

 

20,559

 

 

 

(23,076

)

Net cash provided by financing activities

 

 

39,664

 

 

 

14,648

 

 

 

19,559

 

 

 

41,171

 

Net increase in cash, cash equivalents and restricted cash

 

$

7,105

 

 

$

985

 

Net increase (decrease) in cash, cash equivalents and restricted cash

 

$

19,647

 

 

$

(262

)

 

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, 20172019 and 2016,2018 was $20.5 million and $18.4 million, respectively. The increase in cash used in operating activities forduring the nine months ended September 30, 20172019 compared to nine months ended September 30, 20162018 of $2.1 million was primarily due to an increase in net lossaccrued expenses and other current and non-current liabilities of $11.3$1.2 million, which were offset by a decrease in prepaid expenses, accounts payable of $1.4 million, net loss of $0.8 million and accrued expensesother net changes of $1.2$0.4 million. In addition, there was an increase in the non-cash change in the fair value of the warrant liability of $11.5$4.2 million and an increase in non-cash stock basedstock-based compensation of $0.5$0.8 million, which was offset by a decrease inother non-cash common stock and warrant valuation expense related to the BioHEP license agreementchanges of $2.8 million for$0.1 million.

Net cash provided by (used in) investing activities. Net cash provided by (used in) investing activities during the nine months ended September 30, 2017.

Net2019 and 2018 was $20.6 million and $(23.1) million, respectively. The cash used in investing activities. Net cash used inprovided by investing activities was $19.9 million forduring the nine months ended September 30, 2017 compared to $2.0 million for the nine months ended September 30, 2016. The cash used in investing activities of $19.9 million in the nine months ended September 30, 20172019 was primarily the result of $14.6$26.8 million in proceeds from the sale of marketable securities, which was offset by $34.4 million for the purchase of marketable securities and $0.1 million for the purchase of property and equipment. The cash used in investing activities of $2.0 million for the nine months ended September 30, 2016 was mainly due to proceeds of $4.9 million from the sale of marketable securities, offset by $6.7$6.0 million for the purchase of marketable securities and $0.2 million for the purchase of property and equipment forequipment. The cash used in investing activities during the nine months ended September 30, 2016.2018 was primarily the result of $28.8 million in proceeds from the sale of marketable securities, which was offset by $50.0 million for the purchase of marketable securities and $1.9 million for the purchase of property and equipment.

Net cash provided by financing activities. Net cash provided by financing activities was $39.7 million and $14.6 million during the nine months ended September 30, 20172019 and 2016,2018 was $19.6 million and $41.2 million, respectively. The cash provided by financing activities induring the nine months ended September 30, 20172019 was primarily the result of $42.5 million of gross proceeds from the common stock offering and $0.1$20.0 million of proceeds from the exercise of stock options,Convertible Term Loan and Pontifax Warrants, offset by $2.9$0.4 million of offering expenses.issuance costs in connection with the Convertible Term Loan and Pontifax Warrants. The cash provided by


financing activities induring the nine months ended September 30, 20162018 was primarily the result of $11.3$38.0 million of grossnet proceeds receivedfrom the issuance of common stock and $3.2 million of net proceeds from our IPO, cash of $5.3 million forat-the-market offering program under the exercise of warrants 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 related to our IPO.  Sales Agreement.

Funding Requirements

We expect to continue to incur significant and increasing losses for the foreseeable future. We anticipate these losses to increase as our expenses increase, and we expect that our expenses will increase if and as we:

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

continue preclinical development of SB 11285 and our other product candidatesto develop and initiate clinical trials of SB 11285, and our otherlead STING agonist product candidates, if supported by the preclinical data;  candidate;


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

initiate and continue research and preclinical and clinical development efforts for our other product candidates, including SB 9225, a potential fixed-dose co-formulation product that combines inarigivir and tenofovir disoproxil fumarate;

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 and supply 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.

WeBased on our current operating plan, we expect that our existing cash, cash equivalents and marketable securities as of September 30, 2017 2019 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 and marketable securities will not be sufficient to fund additional development of inarigivir beyond our Phase 2 ACHIEVE clinical trial in patients with chronic HBV. into 2022. We have based this estimate on assumptions that 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,our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the research and development of our product candidates. Our future capital requirements, both near and long-term, will depend on many factors, including, but not limited to:to:

initiation, progress, timing, costs and results of preclinical studies and clinical trials ofevaluating inarigivir, including Part A of our Phase 2 ACHIEVE clinical trial in patients with chronic HBV;

initiation, progress, timing, costsSB 11285 and results of preclinical studies of SB 11285;  9225;

 

initiation, progress, timing, costs and results of preclinical studies and clinical trials of ourany other product candidates;candidates we may develop;

our obligation 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, SB 9225 or any of our other product candidates;


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

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

the outcome, timing and cost of seeking regulatory review by the FDA and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities to require that we perform more studies than those that we currently expect;

the costs of filing, prosecuting, defending and enforcing any patent claims and maintaining and enforcing other intellectual property rights;

subject to receipt of marketing approval, 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 any product candidates for which we may receive regulatory approval; and

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

the costs of operating as a public company.

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. Our commercial revenues, if any, will be derived from sales of products that we do not expect 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 funds may not be available to us on acceptable terms, or at all. We do not currently 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 pursuant to the Registration Statement and a prospectus supplement and accompanying base prospectus that we filed with the SEC on August 18, 2017.  As of September 30, 2017,2019, we had up to $107.5$59.6 million in securities available for future issuance under the S-3 Registration Statement, which includes $50.0$42.7 million in shares issuable pursuant to theour at-the-market program and our 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.

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, weWe have contractual obligations pursuant to our amended and restated license agreement with BioHEP Technologies Ltd., or 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. As of September 30, 2019, there have been no milestone or royalty payments made to BioHEP.

On October 4, 2017,In September 2019, we entered into the Loan and Security Agreement that provides for a New Lease.  $20.0 million term loan that bears annual interest at a rate of 8.0%. The premises covered by the New Lease will serve as our new principal officeLoan and laboratory space.  The initial termSecurity Agreement provides for interest-only payments for twenty-four months and repayment of the New Leaseaggregate outstanding principal balance of the term loan in quarterly installments starting upon expiration of the interest only period and continuing through September 19, 2023. The Loan and Security Agreement is 125 months beginning on the date on which the landlord substantially completes certain renovationsdescribed in Note 9 to the premises covered bynotes to the New Lease, which we expect to occurconsolidated financial statements contained 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.  this Quarterly Report on Form 10-Q.

We enter into contracts in the normal course of business with third 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 upon notice, and therefore we believe that our non-cancelable obligations under these agreements are not material. 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 Pronouncements

In November 2016,August 2018, the Financial Accounting Standards Board, or FASB issued Accounting Standards Update, or ASU No. 2016-18,2018-13, StatementFair Value Measurement (Topic 820), Disclosure Framework – Changes to the Disclosure Requirement for Fair Value Measurement. This ASU removes, modifies and adds certain disclosure requirements 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.ASC Topic 820. The new standard is applied retrospectively andASU is effective for our annual periods beginning after December 15, 2017,all entities for fiscal years, 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 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 our annual reporting periodsfiscal years, 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.

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.31, 2019. We are currently evaluating the impact that the adoption of this standard may have on our consolidated financial statements.

In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 Leases (Topic 842), which supersedes the current leasing guidance and upon adoption, will requirerequires lessees to recognize right-of-use assets and lease liabilitiesmost leases on thetheir balance sheet for all leases with terms longer than 12 months.as a right-of-use asset and a lease liability. Leases are classified as either operating or finance, and classification is based on criteria similar to current lease accounting, but without explicit bright lines. In July 2018, the FASB issued ASU No. 2018-10, “Codification Improvements to Topic 842, Leases” (“ASU 2018-10”), which provides narrow amendments to clarify how to apply certain aspects of the new lease standard, and ASU No. 2018-11, “Leases (Topic 842) – Targeted Improvements” (ASU 2018-11), which addresses implementation issues related to the new lease standard. The new standardguidance is effective for our annual periodreporting periods beginning after December 15, 2018 and can beinterim periods within those fiscal years, and early adopted by applying a modified retrospective approach for leases existingadoption is permitted. Under this standard, disclosures are required to enable users of financial statements in assessing the amount, timing, and uncertainty of cash flows arising from leases. The standard permits two transition methods, (1) to apply the new lease requirements at and entered into after, the beginning of the earliest comparable period presented, or (2) to apply the new lease requirements at the effective date. Under both transition methods there is a cumulative effect adjustment.

We adopted the standard on the effective date of January 1, 2019 by applying the new lease requirements at the effective date. Prior periods continue to be presented based on the accounting standards originally in effect for such periods. We also elected the financial statements. package of practical expedients permitted under the transition guidance within the new standard, which, among other things, allows us to carry forward the historical lease classification. We are currently evaluatingwill also apply the practical expedient not to separate lease and non-lease components for new and modified leases commencing after adoption. The standard had an impact that the adoption of this standard may haveapproximately $3.0 million on our consolidated financial statements.

In September 2016, the FASB issued ASU 2016-15, Classification of Certain Cash Receiptsassets 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$3.4 million on our consolidated financial statements.liabilities, as of January 1, 2019, for the recognition of right-of-use assets and lease liabilities, which are primarily related to the lease of our corporate headquarters in Hopkinton, Massachusetts. The standard did not have a material impact on our results of operations or liquidity.

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)(“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 thatadopted this standard as of January 1, 2019; however, the adoption of this standard may have ondid not impact our consolidated financial statementsstatements.

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 expected to have a material impact on our consolidated financial statements upon adoption.



Item 3.

Quantitative and QualitatiQualive Disclosurestative 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$63.1 million as of September 30, 2017,2019, consisted of cash, money market accountscash equivalents and short-term marketable debt securities. Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates. However, because a significant amount of the short-term nature of the instrumentsmarketable securities in our investment portfolio are short-term in nature, 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.

Item 4.

Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and our principal financial officer, evaluated, as 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, 2017,2019, 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 company in the reports that it files or submits under the Exchange Act are recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that 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 officer and principal financial and accounting 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 quarternine months ended September 30, 2017,2019, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



PART II—OTHER INFORMATION

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.

ThereIn 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, 2018, or the Form 10-K, which could materially affect our business, financial condition, or results of operations. Other than the addition of the following risk factors, there have been no material changes in or additions to the risk factors included in our Annual Report on Form 10-K for the year endedDecember 31, 20162018.

The terms of our loan and security agreement with Pontifax Medison Finance require us to meet certain operating covenants and place restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business.

In September 2019, we entered into a loan and security agreement with Pontifax Medison Finance (the “Loan and Security Agreement”) that is secured by a lien covering all of our assets, other than our intellectual property. The Loan and Security Agreement contains customary affirmative and negative covenants and events of default. Affirmative covenants include, among others, covenants requiring us to protect and maintain our intellectual property, deliver certain financial reports, maintain minimum cash balances of $7.0 million and maintain insurance coverage. Negative covenants include, among others, restrictions on transferring any part of our business or intellectual property; incurring additional indebtedness; engaging in mergers or acquisitions; paying dividends or making other distributions; making investments; and creating other liens on our assets, in each case subject to customary exceptions. Events of default include, among others, non-payment, breaches or defaults in the performance of covenants, insolvency, bankruptcy and the occurrence of a material adverse effect on us. After the occurrence of an event of default the selling shareholders may (i) accelerate payment of all obligations and impose a prepayment charge, (ii) sign and file in our name any notices, assignment or agreements necessary to perfect payment, or (iii) notify any of our account debtors to make payment directly to it.. If we raise any additional debt financing, the terms of such additional debt could further restrict our operating and financial flexibility. These restrictions may include, among other things, limitations on borrowing and specific restrictions on the use of our assets, as well as prohibitions on our ability to create liens, pay dividends, redeem capital stock or make investments. If we default under the terms of the Loan and Security Agreement or any future debt facility, the lender may accelerate all of our repayment obligations and take control of our pledged assets, potentially requiring us to renegotiate our agreement on terms less favorable to us or to immediately cease operations. Further, if we are liquidated, the lender’s right to repayment would be senior to the rights of the holders of our common stock. The lender could declare a default upon the occurrence of any event that they interpret as a material adverse effect as defined under the Loan and Security Agreement. Any declaration by the lender of an event of default could significantly harm our business and prospects and could cause the price of our common stock to decline.

Repayment of our convertible notes, if they are not otherwise converted, will require a significant amount of cash, and we may not have sufficient cash flow from our business to make payments on our indebtedness.

Our ability to pay the principal of or interest on the convertible notes issued under the Loan and Security Agreement (the “Convertible Notes”) depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control. Our business may not generate cash flow from operations in the future sufficient to service the Convertible Notes or other future indebtedness and make necessary capital expenditures. If we are unable to generate such cash flow, we may be required to adopt one or more alternatives, such as selling assets, restructuring indebtedness or obtaining additional debt financing or equity financing on terms that may be onerous or highly dilutive. Our ability to refinance the Convertible Notes or other future indebtedness will depend on the capital markets and our Quarterly Reportfinancial condition at such time. We may not be able to engage in any of these activities or engage in these activities on Form 10-Q fordesirable terms, which could result in a default on our debt obligations, including the quarter ended June 30, 2017.Convertible Notes.

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 Committeeissuance of the Board.

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.

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 priceconversion 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 directorConvertible Notes and in the event of a change in controlexercise of the company,warrants issued under the vesting schedule ofLoan and Security Agreement could substantially dilute your investment and could impede our ability to obtain additional financing.

The Convertible Notes are convertible into and the option will accelerate in full. Dr. Bardon is also entitled to receive an option to purchase 5,500 shares of common stock onwarrants issued under 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 directorLoan 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. BardonSecurity Agreement (the “Pontifax Warrants”) are exercisable 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 and give the holders an opportunity to profit from a rise in the market price of our common stock such that conversion or exercise thereof could result in dilution of the equity interests of our shareholders. We


have no control over whether the holders will exercise their right to convert their Convertible Notes or exercise their Pontifax Warrants. While the Convertible Notes are convertible at a fixed price $8.76 per share and the Pontifax Warrants are exercisable at a fixed price $6.57, both of which are higher than our current market price, we cannot predict the market price of our common stock at any future date, and therefore, cannot predict whether the Convertible Notes will be converted or whether the Pontifax Warrants will be exercised. The existence and potentially dilutive impact of the Convertible Notes and the Pontifax Warrants may prevent us from obtaining additional financing in the future on acceptable terms, or at all.

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds.

On September 19, 2019, we issued a warrant to a group of accredited investors. All investors paid $9.12 for each share of common stock and warrantservice provider 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 3,269,21915,000 shares of our common stock at $13.00 per share.  Oncology Impact Fund purchased 230,769 sharespursuant to Section 4(a)(2) of common stock at the public offering priceSecurities Act of 1933, as amended in this public offering.  Dr. Bardon may be deemed to have a beneficial ownership interest in the shares purchasedexchange for services rendered by the entities identified above.  

There are no arrangements or understandings between Dr. Bardonservice provider. These warrants have an exercise price of $4.21 per share and any other person pursuant to which Dr. Bardon was elected as a director.expire on September 19, 2021.

Item 6.

Exhibits.

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


EXHIBIT INDEX

 

 

 

Exhibit

Number

 

Description

4.1

Form of Pontifax Warrants issued under the Loan and Security Agreement, dated September 3, 2019 (Incorporated by reference to Exhibit 4.2 to the Registrant’s Registration Statement on Form S-3 filed November 1, 2019 (Commission File No. 333-234436)).

10.1

 

Controlled Equity OfferingSM SalesLoan and Security Agreement, dated as of August 18, 2017,September 3, 2019, by and betweenamong Spring Bank Pharmaceuticals, Inc., Pontifax Medison Finance (Israel) L.P. and Cantor Fitzgerald & Co. (incorporatedPontifax Medison Finance (Cayman) L.P. (Incorporated by reference to Exhibit 10.1 to Spring Bank Pharmaceuticals, Inc.’sthe Registrant’s Current Report on Form 8-K filed September 4, 2019 (Commission File No. 001-37718)).

10.2

Registration Rights Agreement, dated September 19, 2019, among Spring Bank Pharmaceuticals, Inc. and the Lender parties thereto (Incorporated by reference to Exhibit 10.2 to the Registrant’s Registration Statement on August 18, 2017)Form S-3 filed November 1, 2019  (Commission File No. 333-234436)).

 

 

 

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.

 

 

 

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.

 

 

 

32.1

 

Certification of Principal Executive Officer and 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

 

XBRL Instance Document

 

 

 

101.SCH

 

XBRL Taxonomy Extension Schema Document

 

 

 

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

101.LAB

 

XBRL Taxonomy Extension Label Linkbase Document

 

 

 

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase Document

 

 


SIGNATURES

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, Inc.

 

 

 

Date: October 31, 2017November 7, 2019

By:

/s/ Jonathan Freve

 

 

Jonathan Freve

 

 

Chief Financial Officer and Treasurer

(Principal Financial and Accounting Officer)

 

 

 

 

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