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 March 31, 2019
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.) |
|
|
|
620 Memorial Drive, Suite 300 Cambridge, Massachusetts |
|
02139 |
(Address of Principal Executive Offices) |
|
(Zip Code) |
(617) 744-1340
(Registrant’s Telephone Number, Including Area Code)
(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)
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. (Check one):
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 April 26, 2019: 42,434,780
2
Cautionary Note Regarding Forward-Looking Statements
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 SY‑1425 and SY‑1365; |
|
• |
our plans to progress SY-5609 through investigational new drug-enabling studies and initiate clinical development; |
|
• |
planned clinical trials for our product candidates, whether conducted by us or by any future collaborators, including the timing of these trials and of the anticipated results; |
|
• |
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 expectations regarding the potential benefits of our gene control platform and our approach; |
|
• |
our ability to enter into, and the terms and timing of, any collaborations, license agreements, or other arrangements; |
|
• |
whether our 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 future 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; and |
|
• |
our estimates regarding expenses, future revenue, capital requirements and need for additional financing. |
3
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, particularly in the “Risk Factors” section, that could cause actual results or events to differ materially from the forward‑looking statements that we make. Our forward‑looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, joint ventures or investments that we may make or enter into. 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)
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2019 |
|
|
2018 |
|
||
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
22,129 |
|
|
$ |
49,886 |
|
Marketable securities |
|
|
53,737 |
|
|
|
49,793 |
|
Prepaid expenses and other current assets |
|
|
1,259 |
|
|
|
1,417 |
|
Restricted cash, current portion |
|
|
638 |
|
|
|
638 |
|
Total current assets |
|
|
77,763 |
|
|
|
101,734 |
|
Property and equipment, net |
|
|
3,897 |
|
|
|
3,861 |
|
Other long-term assets |
|
|
1,103 |
|
|
|
881 |
|
Restricted cash, net of current portion |
|
|
3,376 |
|
|
|
290 |
|
Right-of-use – Operating lease |
|
|
1,308 |
|
|
|
— |
|
Right-of-use – Financing lease |
|
|
981 |
|
|
|
— |
|
Total assets |
|
$ |
88,428 |
|
|
$ |
106,766 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,632 |
|
|
$ |
3,309 |
|
Accrued expenses |
|
|
9,086 |
|
|
|
13,893 |
|
Deferred revenue, current portion |
|
|
1,848 |
|
|
|
1,926 |
|
Deferred rent, current portion |
|
|
— |
|
|
|
392 |
|
Financing and capital lease obligations, current portion |
|
|
221 |
|
|
|
9 |
|
Operating lease obligation, current portion |
|
|
1,192 |
|
|
|
— |
|
Total current liabilities |
|
|
14,979 |
|
|
|
19,529 |
|
Deferred rent, net of current portion |
|
|
— |
|
|
|
353 |
|
Deferred revenue, net of current portion |
|
|
7,900 |
|
|
|
8,276 |
|
Financing and capital lease obligations, net of current portion |
|
|
766 |
|
|
|
22 |
|
Operating lease obligation, net of current portion |
|
|
765 |
|
|
|
— |
|
Commitments and contingencies (See Note 8) |
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized at March 31, 2019 and December 31, 2018; 0 shares issued and outstanding at March 31, 2019 and December 31, 2018 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 200,000,000 shares authorized at March 31, 2019 and December 31, 2018; 33,766,941 and 33,765,864 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively |
|
|
34 |
|
|
|
34 |
|
Additional paid-in capital |
|
|
297,982 |
|
|
|
296,100 |
|
Accumulated other comprehensive gain (loss) |
|
|
8 |
|
|
|
(3 |
) |
Accumulated deficit |
|
|
(234,006 |
) |
|
|
(217,545 |
) |
Total stockholders' equity |
|
|
64,018 |
|
|
|
78,586 |
|
Total liabilities and stockholders' equity |
|
$ |
88,428 |
|
|
$ |
106,766 |
|
See accompanying notes to unaudited condensed consolidated financial statements.
5
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
|
|
2019 |
|
|
2018 |
|
||
Revenue |
|
$ |
454 |
|
|
$ |
370 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
12,562 |
|
|
|
11,116 |
|
General and administrative |
|
|
4,865 |
|
|
|
4,075 |
|
Total operating expenses |
|
|
17,427 |
|
|
|
15,191 |
|
Loss from operations |
|
|
(16,973 |
) |
|
|
(14,821 |
) |
Other income, net |
|
|
512 |
|
|
|
358 |
|
Net loss |
|
$ |
(16,461 |
) |
|
$ |
(14,463 |
) |
Net loss applicable to common stockholders |
|
|
|
|
|
|
|
|
Net loss per share applicable to common stockholders - basic and diluted |
|
$ |
(0.49 |
) |
|
$ |
(0.48 |
) |
Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted |
|
|
33,766,333 |
|
|
|
30,335,164 |
|
See accompanying notes to unaudited condensed consolidated financial statements.
6
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
(unaudited)
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
|
|
2019 |
|
|
2018 |
|
||
Net loss |
|
$ |
(16,461 |
) |
|
$ |
(14,463 |
) |
Other comprehensive gain: |
|
|
|
|
|
|
|
|
Unrealized holding gains on marketable securities |
|
|
11 |
|
|
|
8 |
|
Comprehensive loss |
|
$ |
(16,450 |
) |
|
$ |
(14,455 |
) |
See accompanying notes to unaudited condensed consolidated financial statements.
7
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDER’S EQUITY
(in thousands, except share data)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
Additional |
|
|
Other |
|
|
|
|
|
|
|
|
|
|
|||||||
|
|
Number of |
|
|
Par |
|
|
Paid-In |
|
|
Comprehensive |
|
|
Accumulated |
|
|
Stockholders’ |
|
|
||||||
|
|
Shares |
|
|
Value |
|
|
Capital |
|
|
Gain (Loss) |
|
|
Deficit |
|
|
Equity |
|
|
||||||
Balance at December 31, 2017 |
|
|
26,423,375 |
|
|
$ |
26 |
|
|
$ |
220,606 |
|
|
$ |
(42 |
) |
|
$ |
(155,266 |
) |
|
$ |
65,324 |
|
|
Exercise of stock options |
|
|
58,773 |
|
|
|
— |
|
|
|
242 |
|
|
|
— |
|
|
|
— |
|
|
|
242 |
|
|
Issuance of common stock pursuant to Stock Purchase Agreement, net of issuance costs of $100 |
|
|
793,021 |
|
|
|
1 |
|
|
|
7,647 |
|
|
|
— |
|
|
|
— |
|
|
|
7,648 |
|
|
Issuance of common stock in underwritten public offer, net of issuance costs of $3.3 million |
|
|
4,816,753 |
|
|
|
5 |
|
|
|
42,659 |
|
|
|
— |
|
|
|
— |
|
|
|
42,664 |
|
|
Issuance of common stock through private placement |
|
|
144,505 |
|
|
|
— |
|
|
|
1,380 |
|
|
|
— |
|
|
|
— |
|
|
|
1,380 |
|
|
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
1,696 |
|
|
|
— |
|
|
|
— |
|
|
|
1,696 |
|
|
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
8 |
|
|
|
— |
|
|
|
8 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(14,463 |
) |
|
|
(14,463 |
) |
|
Balance at March 31, 2018 |
|
|
32,236,427 |
|
|
$ |
32 |
|
|
$ |
274,230 |
|
|
$ |
(34 |
) |
|
$ |
(169,729 |
) |
|
$ |
104,499 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2018 |
|
|
33,765,864 |
|
|
$ |
34 |
|
|
$ |
296,100 |
|
|
$ |
(3 |
) |
|
$ |
(217,545 |
) |
|
$ |
78,586 |
|
|
Exercise of stock options |
|
|
1,077 |
|
|
|
— |
|
|
|
3 |
|
|
|
— |
|
|
|
— |
|
|
|
3 |
|
|
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
1,879 |
|
|
|
— |
|
|
|
— |
|
|
|
1,879 |
|
|
Other comprehensive gain |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
11 |
|
|
|
— |
|
|
|
11 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(16,461 |
) |
|
|
(16,461 |
) |
|
Balance at March 31, 2019 |
|
$ |
33,766,941 |
|
|
$ |
34 |
|
|
$ |
297,982 |
|
|
$ |
8 |
|
|
$ |
(234,006 |
) |
|
$ |
64,018 |
|
|
8
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
|
|
2019 |
|
|
2018 |
|
||
Operating activities |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(16,461 |
) |
|
$ |
(14,463 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
517 |
|
|
|
388 |
|
Amortization of financing right-of-use asset |
|
|
15 |
|
|
|
— |
|
Loss on disposal of fixed assets |
|
|
1 |
|
|
|
— |
|
Stock-based compensation expense |
|
|
1,879 |
|
|
|
1,696 |
|
Net amortization of premiums and discounts on marketable securities |
|
|
(296 |
) |
|
|
(69 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
158 |
|
|
|
(519 |
) |
Other long-term assets |
|
|
(14 |
) |
|
|
3 |
|
Accounts payable |
|
|
(610 |
) |
|
|
(562 |
) |
Accrued expenses |
|
|
(4,966 |
) |
|
|
(669 |
) |
Deferred revenue |
|
|
(454 |
) |
|
|
11,882 |
|
Operating lease asset and liabilities |
|
|
(96 |
) |
|
|
— |
|
Deferred rent and lease incentive |
|
|
— |
|
|
|
(87 |
) |
Net cash used in operating activities |
|
|
(20,327 |
) |
|
|
(2,400 |
) |
Investing activities |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(591 |
) |
|
|
(152 |
) |
Purchases of marketable securities |
|
|
(33,638 |
) |
|
|
(2,486 |
) |
Maturities of marketable securities |
|
|
30,000 |
|
|
|
15,000 |
|
Net cash (used in) provided by investing activities |
|
|
(4,229 |
) |
|
|
12,362 |
|
Financing activities |
|
|
|
|
|
|
|
|
Payments on financing and capital lease obligations |
|
|
(40 |
) |
|
|
(44 |
) |
Proceeds from issuance of common stock through employee benefit plans |
|
|
3 |
|
|
|
242 |
|
Proceeds from issuance of common stock in public offerings and private placements, net of issuance costs |
|
|
— |
|
|
|
51,969 |
|
Payment of offering costs |
|
|
(78 |
) |
|
|
— |
|
Net cash (used in) provided by financing activities |
|
|
(115 |
) |
|
|
52,167 |
|
(Decrease) increase in cash, cash equivalents and restricted cash |
|
|
(24,671 |
) |
|
|
62,129 |
|
Cash, cash equivalents and restricted cash (See Note 6) |
|
|
|
|
|
|
|
|
Beginning of period |
|
|
50,814 |
|
|
|
32,688 |
|
End of period |
|
$ |
26,143 |
|
|
$ |
94,817 |
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
8 |
|
|
$ |
1 |
|
Non-cash investing and financing activities |
|
|
|
|
|
|
|
|
Property and equipment received but unpaid as of period end |
|
$ |
230 |
|
|
$ |
6 |
|
Assets acquired under financing lease |
|
$ |
996 |
|
|
$ |
— |
|
Offering costs incurred but unpaid as of period end |
|
$ |
129 |
|
|
$ |
67 |
|
See accompanying notes to unaudited condensed consolidated financial statements.
9
Syros Pharmaceuticals, Inc. (the "Company"), a Delaware corporation formed in November 2011, is a biopharmaceutical company pioneering an understanding of the non-coding regulatory region of the genome to advance a new wave of medicines that control the expression of genes.
The Company is subject to a number of risks similar to those of other early stage companies, including dependence on key individuals; risks inherent in the development and commercialization of medicines to treat human disease; competition from other companies, many of which are larger and better capitalized; risks relating to obtaining and maintaining necessary intellectual property protection; and the need to obtain adequate additional financing to fund the development of its product candidates and discovery activities. If the Company is unable to raise capital when needed or on favorable terms, it would be forced to delay, reduce, eliminate or out-license certain of its research and development programs or future commercialization rights to its product candidates.
The Company has incurred significant annual net operating losses in every year since its inception. It expects to continue to incur significant and increasing net operating losses for at least the next several years. The Company’s net losses were $62.3 million, $54.0 million and $47.7 million for the years ended December 31, 2018, 2017 and 2016, respectively. As of March 31, 2019, the Company had an accumulated deficit of $234.0 million. The Company has not generated any revenues from product sales, has not completed the development of any product candidate and may never have a product candidate approved for commercialization. The Company has financed its operations to date primarily through the sale of equity securities. The Company has devoted substantially all of its financial resources and efforts to research and development and general and administrative expense to support such research and development. The Company’s net losses may fluctuate significantly from quarter to quarter and year to year. Net losses and negative cash flows have had, and will continue to have, an adverse effect on the Company’s stockholders' equity and working capital. In April 2019, the Company raised $70.0 million in gross proceeds from issuance of equity securities in two concurrent public offerings (See Note 10). The Company believes that its cash, cash equivalents and marketable securities of $75.9 million as of March 31, 2019, and the $70.0 million of gross proceeds raised in the April 2019 public offerings, will be sufficient to allow the Company to fund its current operating plan for a period of at least 12 months past the issuance date of these unaudited interim condensed consolidated financial statements.
2. Summary of Significant Accounting Policies
Basis of Presentation
The Company’s unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these financial statements should be read in conjunction with the financial statements as of and for the year ended December 31, 2018 and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 filed with the Securities and Exchange Commission (“SEC”) on March 7, 2019.
The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements except as noted below with respect to the adoption of ASC 842. In the opinion of the Company’s management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments that are necessary to present fairly the Company’s financial position as of March 31, 2019, the results of its operations for the three months ended March 31, 2019 and 2018, statements of shareholder’s equity for three months ended March 31, 2019 and 2018, and statements of cash flows for the three months ended March 31, 2019 and 2018. Such adjustments are of a normal and recurring nature. The results for the three months ended March 31, 2019 are not necessarily indicative of the results for the year ending December 31, 2019, or for any future period.
10
The accompanying condensed consolidated financial statements include the accounts of Syros Pharmaceuticals, Inc. and its wholly owned subsidiaries, Syros Securities Corporation, a Massachusetts corporation formed by the Company in December 2014 to exclusively engage in buying, selling and holding securities on its own behalf, and Syros Pharmaceuticals (Ireland) Limited, an Irish limited liability company formed by the Company in January 2019. All intercompany transactions and balances have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Management considers many factors in selecting appropriate financial accounting policies and in developing the estimates and assumptions that are used in the preparation of the financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, which include, but are not limited to, expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates and whether historical trends are expected to be representative of future trends. Management’s estimation process often may yield a range of potentially reasonable estimates and management must select an amount that falls within that range of reasonable estimates. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not limited to, estimates related to revenue recognition, stock-based compensation expense, accrued expenses and income taxes. Actual results may differ from those estimates or assumptions.
Segment Information
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. The Company's chief operating decision maker is the Chief Executive Officer. The Company and the chief operating decision maker view the Company's operations and manage its business in one operating segment. The Company operates only in the United States.
Cash and Cash Equivalents
The Company considers all highly liquid instruments that have original maturities of three months or less when acquired to be cash equivalents. Cash equivalents, which generally consist of money market funds that invest in U.S. Treasury obligations, as well as overnight repurchase agreements, are stated at fair value. The Company maintains its bank accounts at one major financial institution.
Fair Value of Financial Instruments
ASC 820, Fair Value Measurement (“ASC 820”), established a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). 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 assumption 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.
ASC 820 identified fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 established a three-tier fair value hierarchy that distinguishes between the following:
Level 1—Quoted market prices (unadjusted) in active markets for identical assets or liabilities.
Level 2—Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable, such as quoted market prices, interest rates and yield curves.
Level 3—Unobservable inputs developed using estimates or assumptions developed by the Company, which reflect those that a market participant would use.
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To the extent that the 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 as 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 carrying amounts reflected in the condensed consolidated balance sheets for cash and cash equivalents, prepaid expenses, other current assets, accounts payable, accrued expenses and deferred revenue approximate their fair values, due to their short-term nature.
Revenue Recognition
To date the Company’s only revenue has consisted of collaboration and license revenue. The Company has not generated any revenue from product sales and does not expect to generate any revenue from product sales for the foreseeable future. For the three months ended March 31, 2019, the Company recognized approximately $0.5 million of revenue and for the three months ended March 31, 2018, the Company recognized approximately $0.4 million of revenue, in each case attributable to its target discovery collaboration with Incyte Corporation (“Incyte”).
The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps:
|
(i) |
identify the contract(s) with a customer; |
|
(ii) |
identify the performance obligations in the contract; |
|
(iii) |
determine the transaction price; |
|
(iv) |
allocate the transaction price to the performance obligations in the contract; and |
|
(v) |
recognize revenue when (or as) the entity satisfies a performance obligation. |
The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
From time to time, the Company may enter into agreements that are within the scope of ASC 606. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; and royalties on net sales of licensed products. Each of these payments results in license and collaboration revenues, except for revenues from royalties on net sales of licensed products, which will be classified as royalty revenues.
The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements (“ASC 808”), to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and therefore within the scope of ASC 606. For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently, generally by analogy to ASC 606. For those elements of the arrangement that are accounted for pursuant to ASC 606, the Company applies the five-step model described above.
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Expenditures relating to research and development are expensed in the period incurred. Research and development expenses consist of both internal and external costs associated with the development of the Company’s gene control platform and product candidates. Research and development costs include salaries and benefits, materials and supplies, external research, preclinical and clinical development expenses, stock-based compensation expense and facilities costs. Facilities costs primarily include the allocation of rent, utilities, depreciation and amortization.
In certain circumstances, the Company is required to make nonrefundable advance payments to vendors for goods or services that will be received in the future for use in research and development activities. In such circumstances, the nonrefundable advance payments are deferred and capitalized, even when there is no alternative future use for the research and development, until related goods or services are provided.
The Company records accruals for estimated ongoing research costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the work being performed, including the phase or completion of the event, invoices received and costs. Significant judgements and estimates may be made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates.
The Company may in-license the rights to develop and commercialize product candidates. For each in-license transaction the Company evaluates whether it has acquired processes or activities along with inputs that would be sufficient to constitute a “business” as defined under U.S. GAAP. A “business” as defined under U.S. GAAP consists of inputs and processes applied to those inputs that have the ability to create outputs. Although businesses usually have outputs, outputs are not required for an integrated set of activities to qualify as a business. When the Company determines that it has not acquired sufficient processes or activities to constitute a business, any up-front payments, as well as milestone payments, are immediately expensed as acquired research and development in the period in which they are incurred.
Stock-Based Compensation Expense
The Company accounts for its stock-based compensation awards in accordance with ASC 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees and directors, including grants of restricted stock units and stock option awards, to be recognized as expense in the condensed consolidated statements of operations based on their grant date fair values. Effective January 1, 2019, grants of restricted stock units and stock option awards to other service providers, referred to as non-employees, are measured based on the grant-date fair value of the award and expensed in the Company’s condensed consolidated statement of operations over the vesting period. Through December 31, 2018, grants of restricted stock unit and stock option awards to non-employees were required to be recognized as expense in the consolidated statements of operations based on their vesting date fair values. The Company estimates the fair value of options granted using the Black-Scholes option-pricing model. Prior to June 30, 2016, the Company was a private company and, therefore, lacks Company-specific historical and implied volatility information. As a result, the Company estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. Through December 31, 2018, the expected term of stock options granted to non-employees is equal to the contractual term of the option award. Effective January 1, 2019, the expected term of stock options to non-employees can be determined using either the contractual term of the option award or the “simplified” method. The risk-free interest rate is determined by reference to the U.S. 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 the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The Company uses the value of its common stock to determine the fair value of restricted stock awards.
The amount of stock-based compensation expense recognized during a period is based on the fair value of the portion of the awards that are ultimately expected to vest. The Company accounts for forfeitures as they occur instead of estimating forfeitures at the time of grant. Ultimately, the actual expense recognized over the vesting period will be for only those options that vest.
13
The Company expenses the fair value of its stock-based awards to employees on a straight-line basis over the associated service period, which is generally the vesting period. For stock-based awards granted to non-employees, effective January 1, 2019, comparable with employees, the related expense is recognized on a straight-line basis and is no longer subject to remeasurement at the end of each reporting period. Through December 31, 2018, stock-based compensation expense for awards to non-employees was recognized over the vesting period during which services were rendered by such non-employees and at the end of each financial reporting period prior to vesting, the fair value of these awards was remeasured using the then-current fair value of such awards.
For stock-based awards that contain performance-based milestones, the Company records stock-based compensation expense in accordance with the accelerated attribution model. Management evaluates when the achievement of a performance-based milestone is probable based on the expected satisfaction of the performance conditions as of the reporting date. For certain of the Company’s performance-based awards, notwithstanding any vesting in accordance with the achievement of performance-based milestones, such awards vest in full on the sixth anniversary of the vesting commencement date.
Net Loss per Share
Basic net earnings per share applicable to common stockholders is calculated by dividing net earnings applicable to common stockholders by the weighted average shares outstanding during the period, without consideration for common stock equivalents. Diluted net earnings per share applicable to common stockholders is calculated by adjusting the weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method and the if-converted method. For purposes of the dilutive net loss per share applicable to common stockholders calculation, convertible preferred stock, stock options, warrants and unvested restricted stock are considered to be common stock equivalents but are excluded from the calculation of diluted net loss per share applicable to common stockholders, as their effect would be anti-dilutive; therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented.
The following common stock equivalents were excluded from the calculation of diluted net loss per share applicable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:
|
|
As of March 31, |
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|||||
|
|
2019 |
|
|
2018 |
|
||
Stock options |
|
|
4,616,395 |
|
|
|
3,753,025 |
|
Unvested restricted stock |
|
|
1,078,824 |
|
|
|
— |
|
Total |
|
|
5,695,219 |
|
|
|
3,753,025 |
|
Income Taxes
The Company accounts for income taxes in accordance with ASC Topic 740, Income Taxes. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company’s financial statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on differences between the financial statement carrying amounts and the tax bases of the assets and liabilities using the enacted tax rates in effect in the years in which the differences are expected to reverse. A valuation allowance against deferred tax assets is recorded if, based on the weight of the available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
The Company accounts for uncertain tax positions using a more-likely-than-not threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors including, but not limited to, changes in the law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity, and changes in facts or circumstances related to a tax position.
14
Recent Accounting Pronouncements
In April 2019, the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326 Financial Instruments – Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825 (“ASU 2019-04”). ASU 2019-04 clarifies the accounting treatment for the measurement of credit losses under ASC 236 and provides further clarification on previously issued updates including ASU 2017-12, Derivatives and Hedging (Topic 815): Targeted Improvements to Accounting for Hedging Activities and ASU 2016-01, Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. ASU 2019-04 is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently in the process of evaluating the new standard but does not anticipate ASU 2014-09 will have a material impact on its condensed consolidated financial statements and related disclosures.
In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurements (Topic 820) (“ASU 2018-13”), which provides for changes to the disclosure requirements for recurring and nonrecurring fair value measurements under Topic 820. ASU 2018-13 is effective for fiscal years and interim periods within those fiscal years beginning after December 15, 2019. Provisions of ASU 2018-13 including changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty are required to be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments in ASU 2018-13 should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted upon issuance of ASU 2018-13. The Company is currently in the process of evaluating the new standard but does not anticipate ASU 2018-13 will have a material impact on its condensed consolidated financial statements and related disclosures.
Recently Adopted Accounting Pronouncements
In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASC 842”), which applies to all leases and requires lessees to record most leases on the balance sheet but recognize expense in a manner similar to the previous standard. ASC 842 is effective for fiscal years beginning after December 15, 2018 and interim periods within those years and, as such, is effective starting January 1, 2019 for the Company. Entities are required to use a modified retrospective approach of adoption for leases that exist or are entered into after the beginning of the earliest comparative period in the financial statements. Full retrospective application is prohibited. The modified retrospective approach includes a number of optional practical expedients primarily focused on leases that commenced before the effective date of ASC 842, including continuing to account for leases that commence before the effective date in accordance with previous guidance, unless the lease is modified. In July 2018, the FASB issued ASU No. 2018-11, Leases : Targeted Improvements, which clarifies ASC 842 and provides companies with an optional transition method. The optional transition method allows for companies to adopt ASC 842 as of the January 1, 2019 adoption date and record a cumulative catch-up to related earnings during the period of adoption. The Company adopted ASC 842 on January 1, 2019 and elected to use the practical expedients and therefore the Company is only presenting right-of-use assets and lease liabilities as of the adoption date and additionally elected to not reassess the classification of leases executed prior to the January 1, 2019 adoption date. The primary effect of the new standard, as of the adoption date, is the recording of a right-of-use asset and lease liability for the current operating lease for its office and laboratory facility. As of the January 1, 2019 adoption date, the Company recorded (i) a lease liability of $2.2 million, of which $1.1 million was classified as short-term and $1.1 million as long-term, which represents the present value of remaining lease payments, as of the adoption date, discounted using an incremental borrowing rate of 10% and (ii) a right-of-use asset of approximately $1.5 million classified as long-term, which represents a corresponding amount to the lease liability of $2.2 million adjusted for deferred rent of approximately $0.7 million. The Company also had two immaterial capital leases that, as of the adoption date, are classified as financing leases, with the underlying assets recorded as part of property and equipment, net, in the Company’s condensed consolidated balance sheets.
In June 2018, the FASB issued ASU No. 2018-07, Compensation -Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”). ASU 2018-07 aims to simplify the accounting for share-based payments to nonemployees by aligning it to the accounting for share-based payments to employees including determining the fair value of the award on the date of grant and recognizing the stock-based compensation expense as of the respective vesting date. The new standard also requires companies to elect to either measure the awards to nonemployees over an estimated expected term or contractual term as well as elect to estimate forfeitures or account for forfeitures as incurred. ASU 2018-07 is effective for fiscal years and interim periods within those fiscal years beginning after December 15, 2018. Early adoption is permitted. ASU 2018-07 is to be adopted using a modified retrospective approach with a cumulative catch-up to retained earnings recorded for equity-classified awards for
15
which a measurement date has not been established as of the date of adoption. The Company adopted ASU 2018-07 effective January 1, 2019, and the adoption of the new standard did not have a material impact on the Company’s condensed consolidated financial statements and related disclosures.
3. Agreements with Incyte Corporation
In January 2018, the Company and Incyte entered into a Target Discovery, Research Collaboration and Option Agreement (the “Collaboration Agreement”). Under the Collaboration Agreement, the Company is using its proprietary gene control platform to identify novel therapeutic targets with a focus on myeloproliferative neoplasms, and Incyte has received options to obtain exclusive worldwide rights to intellectual property resulting from the collaboration for the development and commercialization of therapeutic products directed to up to seven validated targets. Incyte will have exclusive worldwide rights to develop and commercialize any therapies under the collaboration that modulate those validated targets.
In January 2018, the Company also entered into a Stock Purchase Agreement with Incyte (the “Stock Purchase Agreement”) whereby, for an aggregate purchase price of $10.0 million, Incyte purchased 793,021 shares of the Company’s common stock at $12.61 per share. Under the terms of the Stock Purchase Agreement, the shares were purchased at a 30% premium over the volume-weighted sale price of the shares of the Company’s common stock over the fifteen (15) trading day period immediately preceding the date of the Stock Purchase Agreement.
Collaboration Agreement
Under the terms of the Collaboration Agreement, Incyte paid the Company $10.0 million in up-front consideration, consisting of $2.5 million in cash and $7.5 million in pre-paid research funding (the “Prepaid Research Amount”). The Company’s activities under the Collaboration Agreement are subject to a joint research plan and, subject to certain exceptions, Incyte is responsible for funding the Company’s activities under the research plan, including amounts in excess of the Prepaid Research Amount. Under the Collaboration Agreement, the Company is required to use commercially reasonable efforts to conduct the research services over a period commencing on the effective date of the Collaboration Agreement and ending upon the completion of specified target validation activities (the "Research Term").
The Company is eligible to receive target selection milestone payments, which extend the period of time in which the options are exercisable, and option exercise fees of up to an aggregate of $54.0 million if Incyte selects the maximum number of targets for validation and exercises its options to obtain exclusive rights to collaboration intellectual property for therapeutic products directed to all seven validated targets. Should any therapeutic product be developed by Incyte against a target as to which Incyte has exercised its option to obtain exclusive rights to collaboration intellectual property, the Company will be eligible to receive milestone payments and, if approved and commercialized, royalty payments from Incyte. For each of the seven validated targets, the Company would become eligible to receive from Incyte a total of up to $50.0 million in development and regulatory milestone payments. If products arising from the collaboration are approved, the Company would become eligible to receive from Incyte, for each validated target, a total of up to $65.0 million in commercial milestone payments. Upon approval and commercialization of any therapeutic product resulting from the collaboration, the Company would become eligible to receive low single-digit royalties on net sales of such product.
The term of the Collaboration Agreement began on January 8, 2018 and, unless terminated by a party early, will continue until all royalty obligations for products arising from the collaboration expire. The Collaboration Agreement may be terminated by Incyte for convenience on sixty (60) days’ prior written notice to the Company, or by the Company on thirty (30) days’ written notice in the event Incyte or one of its affiliates or sublicensees challenges the validity or enforceability of certain patent rights controlled by the Company. The Collaboration Agreement may also be terminated by either of the parties on thirty (30) days’ prior written notice in the event of an uncured material breach of the Collaboration Agreement by the other party or immediately in the case of certain bankruptcy events. If the Collaboration Agreement is terminated by Incyte for material breach, then the Company shall refund any unexpended Prepaid Research Amount. Incyte’s right to terminate for convenience and each party’s right to terminate for uncured material breach may be exercised either with respect to the Collaboration Agreement in its entirety or, as applicable, in relation to the relevant validated target and associated therapeutic products.
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The Company analyzed the Collaboration Agreement to assess whether it is within the scope of ASC 808. As it was determined that the arrangement did not involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities, the Company concluded that the Collaboration Agreement was not within the scope of ASC 808. The Company assessed the Collaboration Agreement and concluded that it represents a contract with a customer within the scope of ASC 606.
The Company has identified a single performance obligation which includes (i) a research license that Incyte retains as long as there remains an unexercised option (the “Research License”) and (ii) research and development services provided during the Research Term (the “Research Services”). The Collaboration Agreement includes options to (x) obtain additional time to exercise the license options for certain targets designated as definitive validation targets and (y) obtain license rights to each validated target, both of which were not considered by the Company’s management to be material rights, and therefore not performance obligations, at inception. The Company’s management believes the options do not provide a material right to the customer that it would receive without entering into the contract principally because the option fees are at least equal to the standalone selling price for the underlying goods. The Research License is not considered distinct as Incyte cannot benefit from the Research License without the Research Services that are separately identifiable in the contract. The Research License only allows Incyte to evaluate the targets developed as part of the conduct of the Research Services under the research plan or conduct work allocated to them during the Research Term. Incyte cannot extract any benefit from the Research License without the Research Services, including the provision of data package information, performed by the Company. As such, these two promises are deemed inputs to a combined output (the delivery of data package allowing Incyte to make an option exercise decision) and are bundled into a single performance obligation (the “Research License and Research Service Performance Obligation”).
At inception, the total transaction price was determined to be $12.3 million, which consisted of a $2.5 million upfront non-refundable and non-creditable payment, the $7.5 million Prepaid Research Amount and $2.3 million in premium paid on the equity investment made pursuant the Stock Purchase Agreement. The Collaboration Agreement also provides for development and regulatory milestones that are only payable subsequent to the exercise of an option and were therefore excluded from transaction price at inception. The Company intends to re-evaluate the transaction price at the end of each reporting period and as uncertain events are resolved or other changes in circumstances occur. There were no changes to the transaction price during the three months ended March 31, 2019.
ASC 606 requires an entity to recognize revenue only when it satisfies a performance obligation by transferring a promised good or service to a customer. A good or service is considered to be transferred when the customer obtains control. As the Research License and Research Services represent one performance obligation, the Company has determined that it will satisfy its performance obligation over a period of time as services are performed and Incyte receives the benefit of the services, as the overall purpose of the arrangement is for the Company to perform the services.
The Company is recognizing revenue related to the Research License and Research Services Performance Obligation as the underlying services are performed using an input measure over the period the Company expects to complete the performance obligation. The Company measures proportional performance based on an input method using actual costs incurred relative to the total estimated costs of the Research Services.
During the three months ended March 31, 2019 and 2018, the Company recognized $0.5 million and $0.4 million of revenue, respectively, that was previously deferred under the Collaboration Agreement. As of March 31, 2019, the Company has deferred revenue outstanding under the Collaboration Agreement of approximately $9.7 million, of which $1.8 million and $7.9 million were classified as current and long-term, respectively, on the Company’s condensed consolidated balance sheets.
The following table presents the changes in deferred revenue for the three months ended March 31, 2019 (in thousands):
Three months ended March 31, 2019 |
|
Balance at Beginning of Period |
|
|
Additions |
|
|
Deductions |
|
|
Balance at End of Period |
|
||||
Deferred revenue |
|
$ |
10,202 |
|
|
$ |
— |
|
|
$ |
454 |
|
|
$ |
9,748 |
|
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4. Cash, Cash Equivalents and Marketable Securities
Cash equivalents are highly liquid investments that are readily convertible into cash with original maturities of three months or less when purchased. Marketable securities consist of securities with original maturities greater than 90 days when purchased. The Company classifies these marketable securities as available-for-sale and records them at fair value in the accompanying condensed consolidated balance sheets. Unrealized gains or losses are included in accumulated other comprehensive gain (loss). Premiums or discounts from par value are amortized to other income over the life of the underlying security.
Cash, cash equivalents and marketable securities consisted of the following at March 31, 2019 and December 31, 2018 (in thousands):
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|||
March 31, 2019 |
|
Amortized Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
||||
Cash and Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and money market funds |
|
$ |
22,129 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
22,129 |
|
Marketable Securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasury obligations |
|
|
53,729 |
|
|
|
8 |
|
|
|
— |
|
|
|
53,737 |
|
Total: |
|
$ |
75,858 |
|
|
$ |
8 |
|
|
$ |
— |
|
|
$ |
75,866 |
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|||
December 31, 2018 |
|
Amortized Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
||||
Cash and Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and money market funds |
|
$ |
34,886 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
34,886 |
|
Overnight repurchase agreements |
|
|
15,000 |
|
|
|
— |
|
|
|
— |
|
|
|
15,000 |
|
Marketable Securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasury obligations |
|
|
49,796 |
|
|
|
— |
|
|
|
(3 |
) |
|
|
49,793 |
|
Total: |
|
$ |
99,682 |
|
|
$ |
— |
|
|
$ |
(3 |
) |
|
$ |
99,679 |
|
Although available to be sold to meet operating needs or otherwise, securities are generally held through maturity. The cost of securities sold is determined based on the specific identification method for purposes of recording realized gains and losses. During the three months ended March 31, 2019, there were no realized gains or losses on sales of investments, and no investments were adjusted for other-than-temporary declines in fair value.
As of March 31, 2019 and December 31, 2018, all marketable securities had maturities of less than twelve months when purchased.
At March 31, 2019, the Company did not hold any securities that were in an unrealized loss position. As a result, the Company determined it did not hold any investments with an other-than-temporary impairment as of March 31, 2019.
5. Fair Value Measurements
Assets measured at fair value on a recurring basis as of March 31, 2019 and December 31, 2018 were as follows (in thousands):
|
|
|
|
|
|
Active |
|
|
Observable |
|
|
Unobservable |
|
|||
|
|
|
|
|
|
Markets |
|
|
Inputs |
|
|
Inputs |
|
|||
Description |
|
March 31, 2019 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
||||
Cash and cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and money market funds |
|
$ |
22,129 |
|
|
$ |
22,129 |
|
|
$ |
— |
|
|
$ |
— |
|
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasury obligations |
|
|
53,737 |
|
|
|
53,737 |
|
|
|
— |
|
|
|
— |
|
|
|
$ |
75,866 |
|
|
$ |
75,866 |
|
|
$ |
— |
|
|
$ |
— |
|
18
|
|
|
|
|
|
Active |
|
|
Observable |
|
|
Unobservable |
|
|||
|
|
|
|
|
|
Markets |
|
|
Inputs |
|
|
Inputs |
|
|||
Description |
|
December 31, 2018 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
||||
Cash and cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and money market funds |
|
$ |
34,886 |
|
|
$ |
34,886 |
|
|
$ |
— |
|
|
$ |
— |
|
Overnight repurchase agreements |
|
|
15,000 |
|
|
|
— |
|
|
|
15,000 |
|
|
|
— |
|
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasury obligations |
|
|
49,793 |
|
|
|
49,793 |
|
|
|
— |
|
|
|
— |
|
|
|
$ |
99,679 |
|
|
$ |
84,679 |
|
|
$ |
15,000 |
|
|
$ |
— |
|
6. Restricted Cash
At March 31, 2019, the Company had $4.0 million in restricted cash, of which $0.6 million was classified as short-term and $3.4 million as long-term.
In connection with the execution of the 2019 Lease (See Note 8), the Company was required to provide the landlord with a letter of credit in the amount of $3.1 million that will expire 95 days after expiration or early termination of the 2019 Lease. The Company will have the right, under certain conditions, to reduce the amount of the letter of credit to $2.1 million in October 2023. The $3.1 million letter of credit is classified as long-term restricted cash on the Company’s condensed consolidated balance sheet as of March 31, 2019.
At December 31, 2018, the Company had $0.9 million in restricted cash, of which $0.6 million was classified as short-term and $0.3 million as long-term.
In August 2018, the Company entered into a manufacturing agreement with a third party for manufacturing services related to one of its product candidates. In accordance with the terms of the manufacturing agreement, the Company was required to provide a letter of credit in the amount of $0.6 million. The letter of credit will expire on September 30, 2019 and is classified as short-term on the Company’s condensed consolidated balance sheets as of March 31, 2019.
The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the amounts shown in the condensed consolidated statement of cash flows as of March 31, 2019, December 31, 2018, March 31, 2018 and December 31, 2017 (in thousands):
|
|
March 31, 2019 |
|
|
December 31, 2018 |
|
|
March 31, 2018 |
|
|
December 31, 2017 |
|
||||
Cash and cash equivalents |
|
$ |
22,129 |
|
|
$ |
49,886 |
|
|
$ |
94,334 |
|
|
$ |
32,205 |
|
Restricted cash, current portion |
|
|
638 |
|
|
|
638 |
|
|
|
193 |
|
|
|
193 |
|
Restricted cash, net of current portion |
|
|
3,376 |
|
|
|
290 |
|
|
|
290 |
|
|
|
290 |
|
Total cash, cash equivalents and restricted cash |
|
$ |
26,143 |
|
|
$ |
50,814 |
|
|
$ |
94,817 |
|
|
$ |
32,688 |
|
7. Accrued Expenses
Accrued expenses consisted of the following as of March 31, 2019 and December 31, 2018 (in thousands):
|
|
March 31, 2019 |
|
|
December 31, 2018 |
|
||
External research and preclinical development |
|
$ |
6,782 |
|
|
$ |
10,119 |
|
Employee compensation and benefits |
|
|
1,331 |
|
|
|
2,985 |
|
Professional fees |
|
|
787 |
|
|
|
618 |
|
Facilities and other |
|
|
186 |
|
|
|
171 |
|
|
|
$ |
9,086 |
|
|
$ |
13,893 |
|
19
8. Commitments and Contingencies
Operating Leases
In March 2015, the Company entered into an operating lease for approximately 21,488 rentable square feet of office and laboratory space in Cambridge, Massachusetts (the “2015 Lease”), with a lease term commencing in August 2015 and ending in October 2020. The Company has an option to extend the 2015 Lease for five additional years. The 2015 Lease has escalating rent payments and the Company records rent expense on a straight-line basis over its term, including any rent-free periods. The 2015 Lease includes certain lease incentives in the form of tenant allowances. Prior to the adoption of ASC 842, the Company capitalized these improvements made with the tenant allowance into fixed assets and established a liability for the deferred lease incentive upon occupancy. The Company recorded these incentives as a component of deferred rent and will amortize these incentives as a reduction of rent expense over the lease term. The related fixed assets are being amortized over the expected lease term. Effective January 1, 2019, upon the adoption of ASC 842, the Company recorded an operating lease right-of use asset and operating lease liability of $1.5 million and $2.2 million, respectively.
On January 8, 2019, the Company entered into a lease (the “2019 Lease”) with respect to approximately 52,859 square feet of space in Cambridge, Massachusetts for a lease term commencing in January 2019 and ending in February 2030. The Company has the option to extend the lease term for one additional ten (10) year period.
In connection with the execution of the 2019 Lease, the Company was required to provide the landlord with a letter of credit in the amount of $3.1 million (See Note 6).
The Company determined that the 2019 Lease’s commencement date, for purposes of applying ASC 842 accounting guidance, did not occur as of March 31, 2019, and therefore no balances related to the 2019 Lease, pursuant to ASC 842, were recorded on the condensed consolidated balance sheet as of March 31, 2019.
Financing Lease
In March 2019, the Company entered into an equipment lease agreement (the “Equipment Lease”) that has a 48 month-term. At the end of the term, the Company has the right to return the leased equipment, extend the lease, or buy the equipment at then-current fair market value of the equipment. The Company accounts for the Equipment Lease as a financing lease under ASC 842 and recorded a financing lease right-of-use asset and a corresponding financing lease liability of approximately $1.0 million.
The following is a maturity analysis of the annual undiscounted cash flows reconciled to the carrying value of the operating and financing lease liabilities as of March 31, 2019 (in thousands):
|
|
Operating |
|
|
Financing/Capital |
|
|
||
|
|
|
|
|
|
|
|
|
|
Nine months ending December 31, 2019 |
|
$ |
995 |
|
|
$ |
228 |
|
|
Year ended December 31, 2020 |
|
|
1,130 |
|
|
|
304 |
|
|
Year ended December 31, 2021 |
|
|
— |
|
|
|
300 |
|
|
Year ended December 31, 2022 |
|
|
— |
|
|
|
299 |
|
|
Year ended December 31, 2023 |
|
|
— |
|
|
|
51 |
|
|
Total minimum lease payments |
|
$ |
2,125 |
|
|
$ |
1,182 |
|
|
Less imputed interest |
|
|
168 |
|
|
|
195 |
|
|
Total minimum lease payments |
|
$ |
1,957 |
|
|
$ |
987 |
|
|
20
The following table outlines the total lease cost for the Company’s operating and financing leases as well as weighted average information for these leases as of March 31, 2019 (in thousands):
|
|
March 31, 2019 |
|
|
|
Lease cost: |
|
|
|
|
|
Operating lease cost |
|
$ |
54 |
|
|
Financing lease cost: |
|
|
|
|
|
Amortization of right-of-use asset |
|
$ |
15 |
|
|
Interest on lease liabilities |
|
$ |
8 |
|
|
Total financing lease cost |
|
$ |
23 |
|
|
Other information: |
|
|
|
|
|
Cash paid for amounts included in the measurement of liabilities - operating |
|
$ |
330 |
|
|
Weighted-average remaining lease term (in years) - operating lease |