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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended June 30, 2020

or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from                   to                     

Commission File Number: 001-38266

 

SPERO THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

46-4590683

 

 

( State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

 

675 Massachusetts Avenue, 14th  Floor

Cambridge, Massachusetts

02139

 

 

(Address of principal executive offices)

(Zip Code)

 

(857) 242-1600

(Registrant’s telephone number, including area code)

 

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

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 par value per share

SPRO

The Nasdaq Global Select Market

 

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

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes  No 

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

 

Large accelerated filer

 

 

Accelerated filer

Non-accelerated filer

 

 

Smaller reporting company

 

 

 

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

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

As of July 30, 2020, the registrant had 21,152,541 shares of common stock, $0.001 par value per share, outstanding.

 

 

 

 


Forward-Looking STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:

 

the initiation, timing, design, progress and results of, including interim data from, our preclinical studies and clinical trials, and our research and development programs;

 

our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;

 

our ability to advance product candidates into, and successfully complete, clinical trials;

 

the timing or likelihood of regulatory filings and approvals;

 

the direct and indirect impact of the pandemic caused by an outbreak of a new strain of coronavirus (“COVID-19”) on our business and operations, including manufacturing, research and development costs, clinical trials, regulatory processes and employee expenses;

 

the commercialization of our product candidates, if approved;

 

the pricing, coverage and reimbursement of our product candidates, if approved;

 

the implementation of our business model and strategic plans for our business and product candidates and our Potentiator Platform;

 

the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our Potentiator Platform;

 

our ability to enter into strategic arrangements and/or collaborations and the potential benefits of such arrangements;

 

our estimates regarding expenses, capital requirements and needs for additional financing;

 

our financial performance;

 

developments relating to our competitors and our industry; and

 

other risks and uncertainties, including those listed under Part II, Item 1A. “Risk Factors”.

Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under Part II, Item 1A. “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

This Quarterly Report on Form 10-Q also contains estimates, projections and other information concerning our industry, our business, and the markets for certain diseases, including data regarding the estimated size of those markets, and the incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources.

 

 

i


Spero Therapeutics, Inc.

Table of Contents

 

 

 

 

Page

 

 

PART I – FINANCIAL INFORMATION

 

Item 1.

 

Financial Statements (Unaudited)

3

 

 

Condensed Consolidated Balance Sheets as of June 30, 2020 and December 31, 2019

3

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2020 and 2019

4

 

 

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2020 and 2019

5

 

 

Condensed Consolidated Statements of Stockholders’ Equity for the three and six months ended June 30, 2020 and 2019

6

 

 

Notes to Unaudited Condensed Consolidated Financial Statements

8

Item 2.

 

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

28

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

40

Item 4.

 

Controls and Procedures

40

 

 

 

 

 

 

PART II – OTHER INFORMATION

 

Item 1A.

 

Risk Factors

41

Item 6.

 

Exhibits

78

 

 

 

 

Signatures

79

 

 

 

ii


PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

SPERO THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

(Unaudited)

 

 

 

June 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

65,342

 

 

$

29,730

 

Marketable securities

 

 

6,018

 

 

 

52,315

 

Other receivables

 

 

4,033

 

 

 

7,760

 

Tax incentive receivable, current

 

 

736

 

 

 

786

 

Prepaid expenses and other current assets

 

 

9,157

 

 

 

4,823

 

Total current assets

 

 

85,286

 

 

 

95,414

 

Property and equipment, net

 

 

1,988

 

 

 

2,273

 

Tax incentive receivable

 

 

339

 

 

 

21

 

Operating lease right of use assets

 

 

4,854

 

 

 

4,875

 

Other assets

 

 

5,078

 

 

 

3,520

 

Total assets

 

$

97,545

 

 

$

106,103

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,562

 

 

$

4,147

 

Accrued expenses and other current liabilities

 

 

16,514

 

 

 

21,588

 

Operating lease liabilities

 

 

936

 

 

 

928

 

Total current liabilities

 

 

19,012

 

 

 

26,663

 

Non-current operating lease liabilities

 

 

4,623

 

 

 

4,617

 

Other long-term liabilities

 

 

196

 

 

 

249

 

Total liabilities

 

 

23,831

 

 

 

31,529

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value; 10,000,000 shares authorized, 5,007 shares issued and outstanding as of June 30, 2020 and 2,720 shares issued and outstanding as of December 31, 2019

 

 

-

 

 

 

-

 

Common stock, $0.001 par value; 60,000,000 shares authorized as of June 30, 2020 and December 31, 2019; 21,014,095 shares issued and outstanding as of June 30, 2020 and 19,190,695 shares issued and outstanding as of December 31, 2019

 

 

21

 

 

 

19

 

Additional paid-in capital

 

 

313,864

 

 

 

273,966

 

Accumulated deficit

 

 

(240,186

)

 

 

(199,427

)

Accumulated other comprehensive gain (loss)

 

 

15

 

 

 

16

 

Total stockholders' equity

 

 

73,714

 

 

$

74,574

 

Total liabilities and stockholders' equity

 

$

97,545

 

 

$

106,103

 

 

 

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

3


SPERO THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share data)

(Unaudited)

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant revenue

 

$

1,676

 

 

$

2,089

 

 

$

3,208

 

 

$

6,000

 

Collaboration revenue

 

 

51

 

 

 

67

 

 

 

220

 

 

 

3,874

 

Total revenues

 

 

1,727

 

 

 

2,156

 

 

 

3,428

 

 

 

9,874

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

15,656

 

 

 

12,026

 

 

 

36,092

 

 

 

21,552

 

General and administrative

 

 

4,547

 

 

 

3,782

 

 

 

8,633

 

 

 

7,670

 

Total operating expenses

 

 

20,203

 

 

 

15,808

 

 

 

44,725

 

 

 

29,222

 

Loss from operations

 

 

(18,476

)

 

 

(13,652

)

 

 

(41,297

)

 

 

(19,348

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

86

 

 

 

367

 

 

 

323

 

 

 

606

 

Other income (expense), net

 

 

889

 

 

 

135

 

 

 

215

 

 

 

520

 

Total other income (expense), net

 

 

975

 

 

 

502

 

 

 

538

 

 

 

1,126

 

Net loss

 

$

(17,501

)

 

$

(13,150

)

 

$

(40,759

)

 

$

(18,222

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share attributable to common stockholders, basic and diluted

 

$

(0.85

)

 

$

(0.74

)

 

$

(2.06

)

 

$

(1.04

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding, basic and diluted:

 

 

20,633,402

 

 

 

17,667,620

 

 

 

20,095,415

 

 

 

17,445,600

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

(17,501

)

 

 

(13,150

)

 

 

(40,759

)

 

 

(18,222

)

Other comprehensive gain (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on marketable securities

 

 

34

 

 

 

5

 

 

 

(1

)

 

 

28

 

Reclassification adjustment for gains included in net loss

 

 

 

 

 

 

 

 

 

 

 

6

 

Net unrealized gains (losses) on securities

 

 

34

 

 

 

5

 

 

 

(1

)

 

 

34

 

Total comprehensive loss

 

$

(17,467

)

 

$

(13,145

)

 

$

(40,760

)

 

$

(18,188

)

 

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

4


SPERO THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

 

 

Six Months Ended June 30,

 

 

 

2020

 

 

2019

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(40,759

)

 

$

(18,222

)

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

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

379

 

 

 

372

 

Non-cash lease cost

 

 

224

 

 

 

 

Share-based compensation

 

 

2,324

 

 

 

1,866

 

Realized (gain) loss on investments

 

 

 

 

 

(1

)

Unrealized foreign currency transaction (gain) loss

 

 

(251

)

 

 

(29

)

Accretion of discount on marketable securities

 

 

(59

)

 

 

(561

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Other receivables

 

 

3,727

 

 

 

(1,697

)

Prepaid expenses and other current assets

 

 

(4,334

)

 

 

1,190

 

Tax incentive receivables

 

 

(252

)

 

 

(235

)

Other assets

 

 

(1,761

)

 

 

(745

)

Accounts payable

 

 

(2,567

)

 

 

(2,526

)

Accrued expenses and other current liabilities

 

 

(4,843

)

 

 

(2,398

)

Other long-term liabilities

 

 

(53

)

 

 

(8

)

Net cash used in operating activities

 

 

(48,225

)

 

 

(22,994

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchases of marketable securities

 

 

(3,995

)

 

 

(32,853

)

Proceeds from maturities of marketable securities

 

 

50,350

 

 

 

82,537

 

Purchases of property and equipment

 

 

(94

)

 

 

(168

)

Net cash provided by (used in) investing activities

 

 

46,261

 

 

 

49,516

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from the issuance of common stock, net of commissions

 

 

7,271

 

 

 

10,251

 

Proceeds from the issuance of common stock related to Rights Offering

 

 

9,416

 

 

 

 

Proceeds from issuance of Series C Preferred Shares

 

 

20,583

 

 

 

 

Payment of offering costs

 

 

(502

)

 

 

(79

)

Proceeds from stock option exercises

 

 

808

 

 

 

359

 

Net cash provided by financing activities

 

 

37,576

 

 

 

10,531

 

Net increase (decrease) in cash and cash equivalents

 

 

35,612

 

 

 

37,053

 

Cash, cash equivalents and restricted cash at beginning of period

 

 

29,730

 

 

 

34,080

 

Cash, cash equivalents and restricted cash at end of period

 

$

65,342

 

 

$

71,133

 

 

 

 

 

 

 

 

 

 

Supplemental disclosure of non-cash investing and financing activities:

 

 

 

 

 

 

 

 

Offering costs in accounts payable and accruals

 

$

 

 

$

79

 

 

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

 

5


SPERO THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands, except share amounts)

 

 

Series A, B and C

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

Accumulated

 

 

Spero Therapeutics, Inc.

 

 

Non-

 

 

Total

 

 

Convertible Preferred Stock

 

 

Common Stock

 

 

Paid-in

 

 

Accumulated

 

 

Other Comprehensive

 

 

Stockholders'

 

 

controlling

 

 

Stockholders'

 

 

Shares

 

 

Par Value

 

 

Shares

 

 

Par Value

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

 

Interests

 

 

Equity

 

Balances at March 31, 2020

 

5,007

 

 

 

 

 

 

20,328,340

 

 

 

20

 

 

 

305,111

 

 

 

(222,685

)

 

 

(19

)

 

 

82,427

 

 

 

 

 

 

82,427

 

Issuance of common stock upon the exercise of stock options

 

 

 

 

 

 

 

40,537

 

 

 

 

 

 

269

 

 

 

 

 

 

 

 

 

269

 

 

 

 

 

 

269

 

Issuance of common stock, net of issuance costs

 

 

 

 

 

 

 

645,218

 

 

 

1

 

 

 

7,270

 

 

 

 

 

 

 

 

 

7,271

 

 

 

 

 

 

7,271

 

Share-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

1,214

 

 

 

 

 

 

 

 

 

1,214

 

 

 

 

 

 

1,214

 

Unrealized gain on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

34

 

 

 

34

 

 

 

 

 

 

34

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(17,501

)

 

 

 

 

 

(17,501

)

 

 

 

 

 

(17,501

)

Balances at June 30, 2020

 

5,007

 

 

 

 

 

 

21,014,095

 

 

 

21

 

 

 

313,864

 

 

 

(240,186

)

 

 

15

 

 

 

73,714

 

 

 

 

 

 

73,714

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Series A, B and C

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

Accumulated

 

 

Spero Therapeutics, Inc.

 

 

Non-

 

 

Total

 

 

Convertible Preferred Stock

 

 

Common Stock

 

 

Paid-in

 

 

Accumulated

 

 

Other Comprehensive

 

 

Stockholders'

 

 

controlling

 

 

Stockholders'

 

 

Shares

 

 

Par Value

 

 

Shares

 

 

Par Value

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

 

Interests

 

 

Equity

 

Balances at December 31, 2019

 

2,720

 

 

 

 

 

 

19,190,695

 

 

 

19

 

 

 

273,966

 

 

 

(199,427

)

 

 

16

 

 

 

74,574

 

 

 

 

 

 

74,574

 

Issuance of common stock upon the exercise of stock options

 

 

 

 

 

 

 

131,933

 

 

 

 

 

 

808

 

 

 

 

 

 

 

 

 

808

 

 

 

 

 

 

808

 

Issuance of common stock, net of offering costs of $462 and net of issuance costs

 

 

 

 

 

 

 

1,691,467

 

 

 

2

 

 

 

16,224

 

 

 

 

 

 

 

 

 

16,226

 

 

 

 

 

 

16,226

 

Issuance of Series C preferred stock, net of offering costs of $41

 

2,287

 

 

 

 

 

 

 

 

 

 

 

 

19,993

 

 

 

 

 

 

 

 

 

19,993