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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

 

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 001-37566

 

SYNLOGIC, INC.

(Exact name of Registrant as specified in its Charter)

 

Delaware

State or other jurisdiction of

incorporation or organization)

 

26-1824804

(I.R.S. Employer

Identification No.)

 

 

 

301 Binney St., Suite 402

Cambridge, MA

(Address of principal executive offices)

 

02142

(Zip Code)

(617) 401-9975

(Registrant’s telephone number, including area code)

 

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

 

Title of each class

Trading Symbol

Name of exchange on which registered

Common Stock, par value $0.001 per share

SYBX

The Nasdaq Capital 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, there were 34,165,785 shares of the registrant’s common stock, par value $0.001 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 herein 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 success of our research and development efforts;

 

the initiation, progress, timing, costs and results of clinical trials for our product candidates;

 

the time and costs involved in obtaining regulatory approvals for our product candidates;

 

the success of our collaborations with third parties;

 

the progress, timing and costs involved in developing manufacturing processes and in manufacturing products, as well as agreements with third-party manufacturers;

 

the rate of progress and cost of our commercialization activities;

 

the expenses we incur in marketing and selling our product candidates;

 

the revenue generated by sales of our product candidates;

 

the emergence of competing or complementary technological developments;

 

the terms and timing of any additional collaborative, licensing or other arrangements that we may establish;

 

the acquisition of businesses, products and technologies;

 

our need to implement additional infrastructure and internal systems;

 

our need to add personnel and financial and management information systems to support our product development and potential future commercialization efforts, and to enable us to operate as a public company;

 

the development of major public health concerns, including the novel coronavirus outbreak or other pandemics arising globally, and the current and future impact of it and COVID-19 on our clinical trials, business operations and funding requirements; 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 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.

 

 


SYNLOGIC, INC.

QUARTERLY REPORT ON FORM 10-Q

TABLE OF CONTENTS

 

 

 

Page

 

 

 

PART I - FINANCIAL INFORMATION

 

 

 

 

 

Item 1. Financial Statements

 

 

 

 

 

Unaudited Consolidated Balance Sheets

 

1

 

 

 

Unaudited Consolidated Statements of Operations and Comprehensive Loss

 

2

 

 

 

Unaudited Consolidated Statements of Stockholders’ Equity

 

3

 

 

 

Unaudited Consolidated Statements of Cash Flows

 

4

 

 

 

Notes to Unaudited Consolidated Financial Statements

 

5

 

 

 

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

 

16

 

 

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

25

 

 

 

Item 4. Controls and Procedures

 

26

 

 

 

PART II - OTHER INFORMATION

 

 

 

 

 

Item 1. Legal Proceedings

 

27

 

 

 

Item 1A. Risk Factors

 

27

 

 

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

55

 

 

 

Item 3. Defaults Upon Senior Securities

 

55

 

 

 

Item 4. Mine Safety Disclosures

 

55

 

 

 

Item 5. Other Information

 

55

 

 

 

Item 6. Exhibits

 

56

 

 

 

Signatures

 

57

 

 

 

 


SYNlogic, Inc. and SUBSIDIARIES

Unaudited Consolidated Balance Sheets

(In thousands, except share amounts)

 

 

 

June 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

31,350

 

 

$

26,184

 

Short-term marketable securities

 

 

77,786

 

 

 

93,387

 

Prepaid expenses and other current assets

 

 

13,096

 

 

 

13,675

 

Total current assets

 

 

122,232

 

 

 

133,246

 

Long-term marketable securities

 

 

 

 

 

7,502

 

Property and equipment, net

 

 

12,055

 

 

 

13,021

 

Right of use asset - operating lease

 

 

16,416

 

 

 

17,263

 

Restricted cash

 

 

1,097

 

 

 

1,097

 

Prepaid research and development, net of current portion

 

 

7,532

 

 

 

16,381

 

Other assets

 

 

61

 

 

 

64

 

Total assets

 

$

159,393

 

 

$

188,574

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,195

 

 

$

2,165

 

Accrued expenses

 

 

2,432

 

 

 

3,946

 

Deferred revenue

 

 

 

 

 

544

 

Lease liability - operating lease

 

 

2,359

 

 

 

2,000

 

Finance lease obligations

 

 

72

 

 

 

208

 

Total current liabilities

 

 

6,058

 

 

 

8,863

 

Long-term liabilities:

 

 

 

 

 

 

 

 

Lease liability - operating lease, net of current portion

 

 

21,581

 

 

 

22,804

 

Finance lease obligations, net of current portion

 

 

 

 

 

2

 

Other long-term liabilities

 

 

82

 

 

 

 

Total long-term liabilities

 

 

21,663

 

 

 

22,806

 

Commitments and contingencies (Note 11)

 

 

 

 

 

 

 

 

Stockholders' Equity

 

 

 

 

 

 

 

 

Common stock, $0.001 par value

 

 

 

 

 

 

 

 

250,000,000 shares authorized as of June 30, 2020 and December 31, 2019.

34,145,111 and 32,266,814 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively.

 

 

34

 

 

 

33

 

Additional paid-in capital

 

 

333,925

 

 

 

327,900

 

Accumulated other comprehensive loss

 

 

214

 

 

 

110

 

Accumulated deficit

 

 

(202,501

)

 

 

(171,138

)

Total stockholders' equity

 

 

131,672

 

 

 

156,905

 

Total liabilities and stockholders' equity

 

$

159,393

 

 

$

188,574

 

 

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

1


 

Synlogic, INC. aND SUBSIDIARIES

Unaudited Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

 

 

For the Three Months Ended

 

 

For the Six Months Ended

 

 

June 30, 2020

 

 

June 30, 2019

 

 

June 30, 2020

 

June 30, 2019

 

Revenue

$

445

 

 

$

350

 

 

$

545

 

$

688

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

12,909

 

 

 

9,703

 

 

 

25,586

 

 

20,087

 

General and administrative

 

3,473

 

 

 

3,742

 

 

 

7,294

 

 

7,393

 

Total operating expenses

 

16,382

 

 

 

13,445

 

 

 

32,880

 

 

27,480

 

Loss from operations

 

(15,937

)

 

 

(13,095

)

 

 

(32,335

)

 

(26,792

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest and investment income

 

406

 

 

 

759

 

 

 

980

 

 

1,516

 

Interest expense

 

(2

)

 

 

(5

)

 

 

(5

)

 

(12

)

Other income (expense)

 

(2

)

 

 

(3

)

 

 

(3

)

 

(2

)

Other income (expense), net

 

402

 

 

 

751

 

 

 

972

 

 

1,502

 

Net loss

$

(15,535

)

 

$

(12,344

)

 

$

(31,363

)

$

(25,290

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share - basic and diluted

$

(0.44

)

 

$

(0.45

)

 

$

(0.91

)

$

(0.96

)

Weighted-average common stock outstanding - basic and diluted

 

34,967,761

 

 

 

27,242,514

 

 

 

34,604,738

 

 

26,284,262

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(15,535

)

 

$

(12,344

)

 

$

(31,363

)

$

(25,290

)

Net unrealized gain (loss) on marketable securities

 

159

 

 

 

29

 

 

 

104

 

 

133

 

Comprehensive loss

$

(15,376

)

 

$

(12,315

)

 

$

(31,259

)

$

(25,157

)

 

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

 

 

2


Synlogic, INC. AND SUBSIDIARIES

Unaudited Consolidated Statements of Stockholders’ Equity

(In thousands, except share amounts)

 

 

 

Common stock

 

 

Additional

 

 

Accumulated other

 

 

 

 

 

 

 

 

 

 

 

$0.001 par value

 

 

paid-in

 

 

comprehensive

 

 

Accumulated

 

 

Total

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

income (loss)

 

 

deficit

 

 

equity

 

 

 

For the Three Months Ended June 30, 2020

 

Balance at March 31, 2020

 

 

32,459,394

 

 

$

33

 

 

$

328,995

 

 

$

55

 

 

$

(186,966

)

 

$

142,117

 

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

 

 

1,778,982

 

 

 

1

 

 

 

3,855

 

 

 

 

 

 

 

 

 

3,856

 

Cancellation of restricted stock

 

 

(93,265

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity-based compensation expense

 

 

 

 

 

 

 

 

1,075

 

 

 

 

 

 

 

 

 

1,075

 

Unrealized gain (loss) on securities

 

 

 

 

 

 

 

 

 

 

 

159

 

 

 

 

 

 

159

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(15,535

)

 

 

(15,535

)

Balance at June 30, 2020

 

 

34,145,111

 

 

$

34

 

 

$

333,925

 

 

$

214

 

 

$

(202,501

)

 

$

131,672

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the Three Months Ended June 30, 2019

 

Balance at March 31, 2019

 

 

25,388,643

 

 

$

25

 

 

$

244,857

 

 

$

39

 

 

$

(132,711

)

 

$

112,210

 

Proceeds from issuance of common stock, net of issuance costs

 

 

6,340,771

 

 

$

7

 

 

$

56,976

 

 

 

 

 

 

 

 

 

56,983

 

Proceeds from pre-funded common stock warrants, net of issuance costs

 

 

 

 

 

 

 

$

22,874

 

 

 

 

 

 

 

 

 

22,874

 

Cancellation of restricted stock

 

 

(9,695

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity-based compensation expense

 

 

 

 

 

 

 

 

1,071

 

 

 

 

 

 

 

 

 

1,071

 

Unrealized gain (loss) on securities

 

 

 

 

 

 

 

 

 

 

 

29

 

 

 

 

 

 

29

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(12,344

)

 

 

(12,344

)

Balance at June 30, 2019

 

 

31,719,719

 

 

$

32

 

 

$

325,778

 

 

$

68

 

 

$

(145,055

)

 

$

180,823

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the Six Months Ended June 30, 2020

 

Balance at December 31, 2019

 

 

32,266,814

 

 

$

33

 

 

$

327,900

 

 

$

110

 

 

$

(171,138

)

 

$

156,905

 

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

 

 

1,778,982

 

 

$

1

 

 

$

3,855

 

 

 

 

 

 

 

 

 

3,856

 

Issuance of restricted stock

 

 

226,335

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cancellation of restricted stock

 

 

(127,020

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity-based compensation expense

 

 

 

 

 

 

 

 

2,170

 

 

 

 

 

 

 

 

 

2,170

 

Unrealized gain (loss) on securities

 

 

 

 

 

 

 

 

 

 

 

104

 

 

 

 

 

 

104

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(31,363

)

 

 

(31,363

)

Balance at June 30, 2020

 

 

34,145,111

 

 

$

34

 

 

$

333,925

 

 

$

214

 

 

$

(202,501

)

 

$

131,672

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the Six Months Ended June 30, 2019

 

Balance at December 31, 2018

 

 

25,401,479

 

 

$

25

 

 

$

243,903

 

 

$

(65

)

 

$

(119,765

)

 

$

124,098

 

Proceeds from issuance of common stock, net of issuance costs

 

 

6,340,771

 

 

$

7

 

 

$

56,976

 

 

 

 

 

 

 

 

 

56,983

 

Proceeds from pre-funded common stock warrants, net of issuance costs

 

 

 

 

 

 

 

$

22,874

 

 

 

 

 

 

 

 

 

22,874

 

Cancellation of restricted stock

 

 

(22,531

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity-based compensation expense

 

 

 

 

 

 

 

 

2,025

 

 

 

 

 

 

 

 

 

2,025

 

Unrealized gain (loss) on securities

 

 

 

 

 

 

 

 

 

 

 

133

 

 

 

 

 

 

133

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(25,290

)

 

 

(25,290

)

Balance at June 30, 2019

 

 

31,719,719

 

 

$

32

 

 

$

325,778

 

 

$

68

 

 

$

(145,055

)

 

$

180,823

 

 

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

 

 

3


Synlogic, INC. AND SUBSIDIARIES

Unaudited Consolidated Statements of Cash Flows

(In thousands)

 

 

 

Six Months Ended

 

 

Six Months Ended

 

 

 

June 30, 2020

 

 

June 30, 2019

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(31,363

)

 

$

(25,290

)

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

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

1,326

 

 

 

1,356

 

Equity-based compensation expense

 

 

2,170

 

 

 

2,025

 

Accretion/amortization of investment securities

 

 

(29

)

 

 

(883

)

Reduction in carrying amount of operating lease right-of-use asset

 

 

848

 

 

 

565

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

582

 

 

 

(32,472

)

Prepaid research and development, net of current portion

 

 

8,849

 

 

 

 

Accounts payable and accrued expenses

 

 

(2,524

)

 

 

(273

)

Deferred revenue

 

 

(544

)

 

 

1,812

 

Operating lease liabilities

 

 

(864

)

 

 

(544

)

Other long-term liabilities

 

 

82

 

 

 

 

Net cash used in operating activities

 

 

(21,467

)

 

 

(53,704

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchases of marketable securities

 

 

(35,744

)

 

 

(108,633

)

Proceeds from maturity of marketable securities

 

 

43,732

 

 

 

89,496

 

Proceeds from redemption of marketable securities

 

 

15,247

 

 

 

 

Purchases of property and equipment

 

 

(320

)

 

 

(695

)

Net cash provided by (used in) investing activities

 

 

22,915

 

 

 

(19,832

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Payments on finance lease obligations

 

 

(138

)

 

 

(131

)

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

 

 

3,856

 

 

 

 

Proceeds from issuance of common stock, net of issuance costs

 

 

 

 

 

56,983

 

Proceeds from issuance of pre-funded common stock warrants, net of issuance costs

 

 

 

 

 

22,874

 

Net cash provided by financing activities

 

 

3,718

 

 

 

79,726

 

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

 

 

5,166

 

 

 

6,190

 

Cash, cash equivalents and restricted cash at beginning of period

 

 

27,281

 

 

 

12,349

 

Cash, cash equivalents and restricted cash at end of period

 

$

32,447

 

 

$

18,539

 

 

 

 

 

 

 

 

 

 

Supplemental disclosure of non-cash investing and financing activities:

 

 

 

 

 

 

 

 

Property and equipment purchases included in accounts payable and accrued expenses

 

$

41

 

 

$

(334

)

Issuance costs included in accounts payable and accrued expenses

 

$

10

 

 

$

100

 

Cash paid for interest

 

$

5

 

 

$

12

 

Assets acquired under operating lease obligation

 

$

 

 

$

1,625

 

 

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

 

 

4


 

SYNLOGIC, INC. AND SUBSIDIARIES

Notes to Unaudited Consolidated Financial Statements

(1)

Nature of Business

Organization

Synlogic, Inc., together with its wholly owned and consolidated subsidiaries (“Synlogic” or the “Company”), is a clinical-stage biopharmaceutical company focused on the discovery and development of Synthetic Biotic™ medicines. Synthetic Biotic medicines are generated from Synlogic’s proprietary drug discovery and development platform, leveraging a reproducible, modular approach to microbial engineering to develop beneficial microbes which perform or deliver critical therapeutic functions. Synthetic Biotic medicines can be designed to sense a local disease context within a patient’s body and respond by metabolizing a toxic substance, compensating for missing or damaged metabolic pathways, or by delivering combinations of therapeutic factors. Synlogic’s goal is to discover, develop, and, ultimately, commercialize Synthetic Biotic medicines. Since incorporation, the Company has devoted substantially all of its efforts to the research and development of its product candidates.

Synlogic, Inc. (“Private Synlogic” when referred to prior to the Merger (as defined below)) was founded and began operations on March 14, 2014, as TMC Therapeutics, Inc., located in Cambridge, Massachusetts. On July 15, 2014, TMC Therapeutics, Inc. changed its name to Synlogic, Inc. On July 2, 2015, the common and preferred stockholders of Private Synlogic executed the Synlogic, LLC Contribution Agreement (the “Contribution Agreement”), pursuant to which such common and preferred stockholders contributed such stockholders’ equity interests in Private Synlogic in exchange for common and preferred units in a newly formed parent company named Synlogic, LLC. In addition, Synlogic IBDCo, Inc. (“IBDCo”) was formed as a subsidiary of Synlogic, LLC (the “2015 Reorganization”). In conjunction with the 2015 Reorganization, Private Synlogic entered into a license, option and merger agreement with AbbVie S.à.r.l. (“AbbVie”), for the development of treatments for inflammatory bowel disease (“IBD”). See Note 9, Collaboration Agreements – AbbVie Collaboration Agreement.

In May 2017, Private Synlogic completed a reorganization (“2017 Reorganization”) pursuant to which Synlogic, LLC merged with and into Private Synlogic, with Private Synlogic continuing as the surviving corporation. Pursuant to the 2017 Reorganization, the common units and preferred units of Synlogic, LLC, together consisting of Class A preferred units, contingently redeemable Class A preferred units and Class B preferred units, were exchanged for common stock and preferred stock of Private Synlogic, respectively. Additionally, Private Synlogic issued equity awards under the Synlogic 2017 Stock Incentive Plan (“2017 Plan”) to replace the canceled incentive units pursuant to the termination of the Synlogic, LLC 2015 Equity Incentive Plan (“2015 LLC Plan”).

On August 28, 2017, Synlogic, Inc., formerly known as Mirna Therapeutics, Inc. (NASDAQ: MIRN) (“Mirna”), completed its business combination with Private Synlogic pursuant to the Agreement and Plan of Merger and Reorganization, dated as of May 15, 2017, by and among Mirna, Meerkat Merger Sub, Inc. (“Merger Sub”), and Private Synlogic (the “Merger Agreement”), pursuant to which Merger Sub merged with and into Private Synlogic, with Private Synlogic surviving as a wholly owned subsidiary of Mirna (the “Merger”). Immediately after completion of the Merger, Mirna changed its name to “Synlogic, Inc.” (NASDAQ: SYBX).

Risks and Uncertainties

At June 30, 2020, the Company had approximately $109.1 million in cash, cash equivalents, and short-term marketable securities, $1.1 million of restricted cash and an accumulated deficit of approximately $202.5 million. Since its inception through June 30, 2020, the Company has primarily financed its operations through the issuance of preferred stock, units and warrants, the sale of its common stock, the AbbVie collaboration, and cash received in the Merger. In the absence of positive cash flows from operations, the Company is highly dependent on its ability to find additional sources of funding in the form of debt or equity financing. Management believes that the Company has sufficient cash to fund its operations through at least twelve months from the issuance of these financial statements.

5


SYNLOGIC, INC. AND SUBSIDIARIES

Notes to Unaudited Consolidated Financial Statements (continued)

 

As an early-stage company, the Company is subject to a number of risks common to other life science companies, including, but not limited to, raising additional capital, development by its competitors of new technological innovations, risk of failure in preclinical and clinical studies, safety and efficacy of its product candidates in clinical trials, the risk of relying on external parties such as contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”), the regulatory approval process, market acceptance of the Company’s products once approved, lack of marketing and sales history, dependence on key personnel and protection of proprietary technology. The Company’s therapeutic programs are currently pre-commercial, spanning discovery through early development and will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization of any product candidates.  These efforts require significant amounts of additional capital, adequate personnel, infrastructure, and extensive compliance-reporting capabilities.  There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary regulatory approval or that any approved products will be commercially viable.  Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate revenue from product sales.  The Company may never achieve profitability, and unless and until it does, it will continue to need to raise additional capital or obtain financing from other sources, such as strategic collaborations or partnerships.

(2)

Summary of Significant Accounting Policies

The significant accounting policies described in the Company’s audited financial statements as of and for the year ended December 31, 2019, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission (“SEC”) on March 12, 2020 (the “2019 Annual Report”), have had no material changes during the three and six months ended June 30, 2020. The updated accounting policy and the impact of adoption are discussed in the “Recently Adopted Accounting Pronouncements” section in this note.

 

 

Basis of Presentation

The accompanying consolidated financial statements and the related disclosures as of June 30, 2020 and for the three and six months ended June 30, 2020 and 2019 are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and the rules and regulations of the SEC for interim financial statements.  Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements.  These interim consolidated financial statements should be read in conjunction with the Company’s 2019 and 2018 audited consolidated financial statements and notes included in the Company’s 2019 Annual Report. The December 31, 2019 consolidated balance sheet included herein was derived from the audited financial statements as of that date but does not include all disclosures including notes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim consolidated financial statements reflect all adjustments, consisting of normal and recurring adjustments, necessary for the fair presentation of the Company’s financial position and results of operations for the three and six months ended June 30, 2020 and 2019.  The results of operations for the interim periods are not necessarily indicative of the results to be expected for the year ending December 31, 2020 or any other interim period or future year or period.

Principles of Consolidation

The accompanying consolidated financial statements include the accounts of Synlogic and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.