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pa

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 June 30, 2023

OR

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

Commission file number: 001-37813

SYROS PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

 

Delaware

 

45-3772460

(State or Other Jurisdiction of

Incorporation or Organization)

 

(I.R.S. Employer

Identification No.)

 

35 CambridgePark Drive, 4th Floor

Cambridge, Massachusetts

 

02140

(Address of Principal Executive Offices)

 

(Zip Code)

(617) 744-1340

(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

 

SYRS

 

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

Number of shares of the registrant’s common stock, $0.001 par value, outstanding on August 4, 2023: 20,710,046

 

 


 

TABLE OF CONTENTS

 

Page

Part I – FINANCIAL INFORMATION

 

 

Item 1. Financial Statements (unaudited)

5

 

 

Condensed Consolidated Balance Sheets as of June 30, 2023 and December 31, 2022

5

Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2023 and 2022

6

Condensed Consolidated Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 2023 and 2022

7

Condensed Consolidated Statements of Stockholder’s Equity for the Three and Six Months Ended June 30, 2023 and 2022

8

Condensed Consolidated Statements of Cash Flows for the Three and Six Months Ended June 30, 2023 and 2022

10

Notes to Condensed Consolidated Financial Statements

11

 

 

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

31

 

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

43

 

 

Item 4. Controls and Procedures

43

 

 

Part II – OTHER INFORMATION

 

 

Item 1A. Risk Factors

44

 

 

Item 6. Exhibits

47

 

 

Signatures

49

 

2


 

Cautionary Note Regarding Forward-Looking Statements and Industry Data

This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward‑looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Quarterly Report, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management and expected market growth are forward‑looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward‑looking statements, although not all forward‑looking statements contain these identifying words. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. The forward‑looking statements and opinions contained in this Quarterly Report are based upon information available to us as of the date of this Quarterly Report and, while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information.

These forward‑looking statements include, among other things, statements about:

our plans to initiate and expand clinical trials of our product candidates and our expectations for the timing, quantity and quality of information to be reported from our clinical trials of tamibarotene, SY-2101 and SY‑5609;
our planned clinical trials for our product candidates, whether conducted by us or by any collaborators, including the timing of these trials and of the anticipated results;
our ability to replicate in any clinical trial of one of our product candidates the results we observed in preclinical or earlier clinical studies of such product candidate;
our plans to research, develop, seek approval for, manufacture and commercialize our current and future product candidates;
our plans to develop and seek approval of companion diagnostic tests for use in identifying patients who may benefit from treatment with our products and product candidates;
our ability to enter into, and the terms and timing of, any collaborations, license agreements, or other arrangements;
whether our target discovery collaboration with Incyte Corporation, or Incyte, will yield any validated targets, whether Incyte will exercise any of its options to exclusively license intellectual property directed to such targets, and whether and when any of the target validation fees, option exercise fees, milestone payments or royalties under the Incyte collaboration will ever be paid;
the potential benefits of any collaboration;
developments relating to our competitors and our industry;
the impact of government laws and regulations;
the timing of and our ability to file new drug applications and obtain and maintain regulatory approvals for our product candidates;
the rate and degree of market acceptance and clinical utility of any products for which we receive marketing approval;
our commercialization, marketing and manufacturing capabilities and strategy;
our intellectual property position and strategy;
our ability to identify additional products or product candidates with significant commercial potential;
our expectations related to the use of our current cash, cash equivalents and marketable securities and the period of time in which such capital will be sufficient to fund our planned operations;
our estimates regarding expenses, future revenue, capital requirements and need for additional financing; and

3


 

general economic conditions, including inflation, recession risk and increasing interest rates.

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. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward‑looking statements contained in this Quarterly Report.

We have included important factors in the cautionary statements included in this Quarterly Report that could cause actual results or events to differ materially from the forward-looking statements that we make. In particular, the extent to which the COVID-19 pandemic continues to impact our operations and those of the third parties on which we rely will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity of the pandemic, additional or modified government actions, and the actions that may be required to contain the coronavirus or treat its impact. COVID-19 has and may continue to adversely impact our operations and workforce, including our supply chain and clinical trial operations activities, which in turn could have an adverse impact on our business and financial results.

Our forward‑looking statements also do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, joint ventures or investments that we may make or enter into.

This report also includes statistical and other industry and market data that we obtained from industry publications and research, surveys, and studies conducted by third parties as well as our own estimates. All of the market data used in this report involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such data. Industry publications and third-party research, surveys, and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. Our estimates of the potential market opportunities for our drug candidates include several key assumptions based on our industry knowledge, industry publications, third-party research, and other surveys, which may be based on a small sample size and may fail to accurately reflect market opportunities. While we believe that our internal assumptions are reasonable, no independent source has verified such assumptions.

You should read this Quarterly Report completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward‑looking statements, whether as a result of new information, future events or otherwise, except as required by law.

4


 

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements (unaudited)

SYROS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

(unaudited)

 

 

June 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

115,442

 

 

$

167,467

 

Marketable securities

 

 

28,540

 

 

 

34,837

 

Unbilled receivable

 

 

1,756

 

 

 

1,694

 

Prepaid expenses and other current assets

 

 

6,892

 

 

 

7,394

 

Total current assets

 

 

152,630

 

 

 

211,392

 

Property and equipment, net

 

 

10,299

 

 

 

11,353

 

Other long-term assets

 

 

2,229

 

 

 

5,348

 

Restricted cash

 

 

3,086

 

 

 

3,086

 

Right-of-use asset – operating lease

 

 

12,731

 

 

 

13,231

 

Right-of-use assets – financing leases

 

 

7

 

 

 

76

 

Total assets

 

$

180,982

 

 

$

244,486

 

Liabilities and stockholders' equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

6,693

 

 

$

6,411

 

Accrued expenses

 

 

17,328

 

 

 

17,966

 

Deferred revenue, current portion

 

 

2,185

 

 

 

4,330

 

Financing lease obligations, current portion

 

 

8

 

 

 

65

 

Operating lease obligation, current portion

 

 

2,161

 

 

 

2,006

 

Total current liabilities

 

 

28,375

 

 

 

30,778

 

Operating lease obligation, net of current portion

 

 

19,726

 

 

 

20,851

 

Warrant liabilities

 

 

18,712

 

 

 

24,472

 

Debt, net of debt discount, long term

 

 

40,930

 

 

 

40,649

 

Commitments and contingencies (See Note 10)

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

Preferred stock, $0.001 par value; 10,000,000 shares authorized at June 30, 2023 and December 31, 2022; 0 shares issued and outstanding at June 30, 2023 and December 31, 2022

 

 

 

 

 

 

Common stock, $0.001 par value; 70,000,000 and 70,000,000 shares authorized at June 30, 2023 and December 31, 2022, respectively; 20,708,356 and 20,263,116 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively

 

 

20

 

 

 

20

 

Additional paid-in capital

 

 

691,450

 

 

 

685,847

 

Accumulated other comprehensive income

 

 

49

 

 

 

102

 

Accumulated deficit

 

 

(618,280

)

 

 

(558,233

)

Total stockholders' equity

 

 

73,239

 

 

 

127,736

 

Total liabilities and stockholders' equity

 

$

180,982

 

 

$

244,486

 

See accompanying notes to unaudited condensed consolidated financial statements.

5


 

SYROS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

(unaudited)

 

 

Three Months Ended

 

 

Six Months Ended

 

 

June 30,

 

 

June 30,

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

 

Revenue

 

$

2,833

 

 

$

6,276

 

 

$

5,787

 

 

$

11,743

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

29,608

 

 

 

33,100

 

 

 

58,369

 

 

 

58,271

 

 

General and administrative

 

 

7,225

 

 

 

6,945

 

 

 

14,630

 

 

 

13,894

 

 

Total operating expenses

 

 

36,833

 

 

 

40,045

 

 

 

72,999

 

 

 

72,165

 

 

Loss from operations

 

 

(34,000

)

 

 

(33,769

)

 

 

(67,212

)

 

 

(60,422

)

 

Interest income

 

 

2,125

 

 

 

112

 

 

 

3,900

 

 

 

147

 

 

Interest expense

 

 

(1,278

)

 

 

(981

)

 

 

(2,495

)

 

 

(1,956

)

 

Change in fair value of warrant liabilities

 

 

(3,105

)

 

 

157

 

 

 

5,760

 

 

 

2,604

 

 

Net loss applicable to common stockholders

 

$

(36,258

)

 

$

(34,481

)

 

$

(60,047

)

 

$

(59,627

)

 

Net loss per share applicable to common stockholders - basic and diluted

 

$

(1.30

)

 

$

(5.40

)

 

$

(2.15

)

 

$

(9.40

)

 

Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted

 

 

27,913,448

 

 

 

6,382,378

 

 

 

27,878,030

 

 

 

6,344,191

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

6


 

SYROS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(in thousands)

(unaudited)

 

 

Three Months Ended

 

 

 

Six Months Ended

 

 

June 30,

 

 

 

June 30,

 

 

2023

 

 

2022

 

 

 

2023

 

 

2022

 

 

Net loss

 

$

(36,258

)

 

$

(34,481

)

 

 

$

(60,047

)

 

$

(59,627

)

 

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized holding loss on marketable securities, net of tax

 

 

(214

)

 

 

(40

)

 

 

 

(53

)

 

 

(234

)

 

Comprehensive loss

 

$

(36,472

)

 

$

(34,521

)

 

 

$

(60,100

)

 

$

(59,861

)

 

See accompanying notes to unaudited condensed consolidated financial statements.

7


 

SYROS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

For the three months ended June 30, 2023 and 2022

(in thousands, except share data)

(unaudited)

 

 

Common Stock

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

 

 

 

Number of

 

 

Par

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Value

 

 

Capital

 

 

Gain (Loss)

 

 

Deficit

 

 

Equity

 

Balance at March 31, 2022

 

 

6,280,129

 

 

$

6

 

 

$

551,734

 

 

$

(273

)

 

$

(488,725

)

 

$

62,742

 

Vesting of restricted stock units

 

 

5,478

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of shares under Employee Stock Purchase Plan

 

 

13,293

 

 

 

 

 

 

109

 

 

 

 

 

 

 

 

 

109

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

2,689

 

 

 

 

 

 

 

 

 

2,689

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(40

)

 

 

 

 

 

(40

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(34,481

)

 

 

(34,481

)

Balance at June 30, 2022

 

 

6,298,900

 

 

$

6

 

 

$

554,532

 

 

$

(313

)

 

$

(523,206

)

 

$

31,019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at March 31, 2023

 

 

20,409,130

 

 

$

20

 

 

$

688,492

 

 

$

263

 

 

$

(582,022

)

 

$

106,753

 

Vesting of restricted stock units and issuance of restricted stock awards

 

 

33,304

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of prefunded warrants

 

 

211,840

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of shares under Employee Stock Purchase Plan

 

 

54,082

 

 

 

 

 

 

144

 

 

 

 

 

 

 

 

 

144

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

2,814

 

 

 

 

 

 

 

 

 

2,814

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(214

)

 

 

 

 

 

(214

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(36,258

)

 

 

(36,258

)

Balance at June 30, 2023

 

 

20,708,356

 

 

$

20

 

 

$

691,450

 

 

$

49

 

 

$

(618,280

)

 

$

73,239

 

 

 

8


 

SYROS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

For the six months ended June 30, 2023 and 2022

(in thousands, except share data)

(unaudited)

 

 

Common Stock

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

 

 

 

Number of

 

 

Par

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Value

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2021

 

 

6,202,403

 

 

$

6

 

 

$

548,870

 

 

$

(79

)

 

$

(463,579

)

 

$

85,218

 

Exercise of stock options

 

 

3,770

 

 

 

 

 

 

1

 

 

 

 

 

 

 

 

 

1

 

Vesting of restricted stock units

 

 

79,434

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of shares under Employee Stock Purchase Plan

 

 

13,293

 

 

 

 

 

 

109

 

 

 

 

 

 

 

 

 

109

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

5,552

 

 

 

 

 

 

 

 

 

5,552

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(234

)

 

 

 

 

 

(234

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(59,627

)

 

 

(59,627

)

Balance at June 30, 2022

 

 

6,298,900

 

 

$

6

 

 

$

554,532

 

 

$

(313

)

 

$

(523,206

)

 

$

31,019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2022

 

 

20,263,116

 

 

 

20

 

 

 

685,847

 

 

 

102

 

 

 

(558,233

)

 

 

127,736

 

Vesting of restricted stock units

 

 

144,327

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of prefunded warrants

 

 

246,831

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of shares under Employee Stock Purchase Plan

 

 

54,082

 

 

 

 

 

 

144

 

 

 

 

 

 

 

 

 

144

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

5,459

 

 

 

 

 

 

 

 

 

5,459

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(53

)

 

 

 

 

 

(53

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(60,047

)

 

 

(60,047

)

Balance at June 30, 2023

 

 

20,708,356

 

 

 

20

 

 

 

691,450

 

 

 

49

 

 

 

(618,280

)

 

 

73,239

 

 

9


 

SYROS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

 

Six Months Ended

 

 

 

June 30,

 

 

 

2023

 

 

2022

 

Operating activities

 

 

 

 

 

 

Net loss

 

$

(60,047

)

 

$

(59,627

)

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

 

 

 

 

 

 

Depreciation and amortization

 

 

1,288

 

 

 

1,342

 

Non-cash lease expense

 

 

69

 

 

 

131

 

Stock-based compensation expense

 

 

5,459

 

 

 

5,552

 

Change in fair value of warrant liabilities

 

 

(5,760

)