UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2018
OR
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ________to _________
Commission File Number: 001-38470
Unity Biotechnology, Inc.
(Exact Name of Registrant as Specified in its Charter)
Delaware |
26-4726035 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
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3280 Bayshore Blvd. Suite 100 Brisbane, CA |
94005 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (650) 416-1192
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
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☒ (Do not check if a smaller reporting company) |
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Smaller reporting company |
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Emerging growth company |
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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 August 3, 2018, the registrant had 42,314,738 shares of common stock, $0.0001 par value per share, outstanding.
QUARTERLY REPORT ON FORM 10-Q
Table of Contents
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Item 1 |
2 |
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Condensed Balance Sheets as of June 30, 2018 (unaudited) and December 31, 2017 |
2 |
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3 |
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Condensed Statements of Cash Flows for the Six Months Ended June 30, 2018 and 2017 (unaudited) |
4 |
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5 |
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Item 2 |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
22 |
Item 3 |
29 |
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Item 4 |
29 |
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Item 1 |
29 |
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Item 1A |
29 |
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Item 2 |
73 |
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Item 3 |
73 |
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Item 4 |
73 |
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Item 5 |
73 |
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Item 6 |
74 |
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76 |
1
Item 1. Condensed Financial Statements
Unity Biotechnology, Inc.
(In thousands, except share and per share amounts)
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June 30, 2018 |
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December 31, 2017 |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
34,165 |
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$ |
7,298 |
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Contribution receivable |
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— |
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1,382 |
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Short-term marketable securities |
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151,806 |
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79,212 |
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Prepaid expenses and other current assets |
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1,650 |
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988 |
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Total current assets |
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187,621 |
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88,880 |
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Property and equipment, net |
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6,595 |
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6,958 |
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Long-term marketable securities |
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12,073 |
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5,118 |
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Restricted cash |
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550 |
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550 |
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Other long-term assets |
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1,617 |
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518 |
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Total assets |
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$ |
208,456 |
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$ |
102,024 |
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Liabilities, convertible preferred stock, and stockholders’ equity (deficit) |
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Current liabilities: |
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Accounts payable |
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$ |
1,883 |
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$ |
2,378 |
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Accrued compensation |
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1,941 |
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2,181 |
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Accrued and other current liabilities |
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4,856 |
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3,338 |
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Contingent consideration liability |
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725 |
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— |
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Total current liabilities |
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9,405 |
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7,897 |
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Deferred rent, net of current portion |
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2,867 |
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3,166 |
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Contingent consideration liability, net of current portion |
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1,033 |
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— |
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Other non-current liabilities |
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82 |
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118 |
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Total liabilities |
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13,387 |
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11,181 |
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Commitments and contingencies (Note 6) |
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Convertible preferred stock, $0.0001 par value; 10,000,000 and 91,739,149 shares authorized as of June 30, 2018 and December 31, 2017, respectively; 28,159,724 shares issued and outstanding as of December 31, 2017; aggregate liquidation preference of $190,825 as of December 31, 2017 |
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— |
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173,956 |
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Stockholders’ equity (deficit): |
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Common stock, $0.0001 par value; 300,000,000 and 122,000,000 shares authorized as of June 30, 2018 and December 31, 2017, respectively; 42,314,738 and 4,830,389 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively |
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4 |
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1 |
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Additional paid-in capital |
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318,758 |
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4,072 |
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Related party promissory notes for purchase of common stock |
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(201 |
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(202 |
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Employee promissory notes for purchase of common stock |
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(400 |
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— |
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Accumulated other comprehensive loss |
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(77 |
) |
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(104 |
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Accumulated deficit |
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(123,015 |
) |
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(86,880 |
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Total stockholders’ equity (deficit) |
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195,069 |
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(83,113 |
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Total liabilities, convertible preferred stock, and stockholders’ equity (deficit) |
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$ |
208,456 |
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$ |
102,024 |
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See accompanying notes to the condensed financial statements.
2
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2018 |
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2017 |
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2018 |
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2017 |
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Operating expenses: |
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Research and development |
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$ |
15,198 |
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$ |
9,213 |
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$ |
28,223 |
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$ |
16,183 |
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General and administrative |
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3,842 |
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2,485 |
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7,299 |
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4,555 |
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Fair value of contingent consideration |
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1,758 |
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— |
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1,758 |
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— |
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Total operating expenses |
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20,798 |
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11,698 |
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37,280 |
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20,738 |
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Loss from operations |
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(20,798 |
) |
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(11,698 |
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(37,280 |
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(20,738 |
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Interest income |
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826 |
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278 |
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1,178 |
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386 |
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Other expense, net |
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(30 |
) |
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(8 |
) |
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(33 |
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(10 |
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Net loss |
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(20,002 |
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(11,428 |
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(36,135 |
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(20,362 |
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Other comprehensive loss |
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Unrealized gain (loss) on marketable securities, net of tax |
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61 |
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(18 |
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27 |
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(20 |
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Comprehensive loss |
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$ |
(19,941 |
) |
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$ |
(11,446 |
) |
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$ |
(36,108 |
) |
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$ |
(20,382 |
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Net loss per share, basic and diluted |
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$ |
(0.76 |
) |
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$ |
(3.62 |
) |
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$ |
(2.41 |
) |
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$ |
(6.53 |
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Weighted average number of shares used in computing net loss per share, basic and diluted |
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26,298,666 |
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3,154,515 |
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15,003,493 |
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3,117,220 |
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See accompanying notes to the condensed financial statements.
3
Condensed Statements of Cash Flows
(In thousands)
(Unaudited)
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Six Months Ended June 30, |
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2018 |
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2017 |
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Operating activities |
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Net loss |
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$ |
(36,135 |
) |
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$ |
(20,362 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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1,023 |
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388 |
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Amortization of premium and discounts on marketable securities |
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(203 |
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105 |
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Stock-based compensation |
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4,208 |
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938 |
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Accretion of tenant improvement allowance |
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(305 |
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(302 |
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Change in fair value of contingent consideration for license agreements |
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1,758 |
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— |
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Changes in operating assets and liabilities: |
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Contribution receivable |
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1,382 |
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— |
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Prepaid expenses and other current assets |
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(662 |
) |
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(513 |
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Other long-term assets |
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(1,099 |
) |
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25 |
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Accounts payable |
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(633 |
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1,798 |
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Accrued compensation |
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(240 |
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249 |
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Accrued liabilities and other current liabilities |
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970 |
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(226 |
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Deferred rent, net of current portion |
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4 |
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263 |
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Net cash used in operating activities |
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(29,932 |
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(17,637 |
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Investing activities |
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Purchase of marketable securities |
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(137,803 |
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(110,285 |
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Maturities of marketable securities |
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58,484 |
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4,750 |
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Purchase of property and equipment |
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(526 |
) |
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(984 |
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Net cash used in investing activities |
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(79,845 |
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(106,519 |
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Financing activities |
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Proceeds from issuance of convertible preferred stock, net of issuance costs |
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59,899 |
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42,880 |
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Proceeds from issuance of common stock upon exercise of stock options, net of repurchases |
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33 |
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(6 |
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Proceeds from issuance of common stock in initial public offering, net of commissions |
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79,050 |
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— |
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Payment of initial public offering costs |
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(3,199 |
) |
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— |
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Proceeds from repayment of recourse notes |
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895 |
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— |
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Payments made on capital lease obligations |
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(34 |
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— |
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Net cash provided by financing activities |
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136,644 |
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42,874 |
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Net increase (decrease) in cash, cash equivalents and restricted cash |
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26,867 |
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(81,282 |
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Cash, cash equivalents and restricted cash at beginning of year |
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7,848 |
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89,736 |
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Cash, cash equivalents and restricted cash at end of year |
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$ |
34,715 |
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$ |
8,454 |
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Supplemental Disclosures of Non-Cash Investing and Financing Information |
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Property and equipment included in accounts payable |
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$ |
138 |
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$ |
528 |
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Property and equipment acquired under capital leases |
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$ |
— |
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$ |
96 |
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Receipt of promissory note from related party for purchase of common stock |
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$ |
390 |
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$ |
— |
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Receipt of promissory note from employees for purchase of common stock |
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$ |
400 |
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$ |
— |
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See accompanying notes to the condensed financial statements.
4
Notes to Condensed Financial Statements
(Unaudited)
1. Organization
Description of Business
Unity Biotechnology, Inc. (the “Company” or “we” or “our” or “us”) is a biotechnology company engaged in the research and development of therapeutics to extend human healthspan. The Company devotes substantially all of its time and efforts to performing research and development, raising capital and recruiting personnel. The Company is located in Brisbane, California, was incorporated in the State of Delaware in March 2009 under the name Forge, Inc. and operates in one segment. The Company changed its name to Unity Biotechnology, Inc. in January 2015.
Initial Public Offering
On May 7, 2018, the Company closed its initial public offering (“IPO”), of 5,000,000 shares of common stock, at an offering price to the public of $17.00 per share. The Company received net proceeds of approximately $75.9 million, after deducting underwriting discounts, commissions and offering related transaction costs of approximately $9.1 million. In connection with the IPO, all of the Company’s outstanding shares of convertible preferred stock were automatically converted into 32,073,149 shares of common stock. In addition, all of our convertible preferred stock warrants were converted into warrants to purchase shares of common stock.
In connection with the completion of its IPO, on May 7, 2018, the Company’s certificate of incorporation was amended and restated to provide for 300,000,000 authorized shares of common stock with a par value of $0.0001 per share and 10,000,000 authorized shares of preferred stock with a par value of $0.0001 per share.
2. Summary of Significant Accounting Policies
Basis of Presentation
These financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) the rules and regulations of United States Securities and Exchange Commission (“SEC”) for interim reporting.
The condensed financial statements are unaudited and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, necessary for the fair presentation for interim reporting. The results of operations for any interim period are not necessarily indicative of results of operations for any future period. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted. Accordingly, the unaudited condensed financial statements should be read in conjunction with the financial statements as of and for the year ended December 31, 2017, which are included in the Company’s prospectus related to the Company’s initial public offering, filed May 4, 2018 (the “Prospectus”), pursuant to Rule 424 (b) under the Securities Act of 1933, as amended with the SEC.
Reverse Stock Split
On April 19, 2018, the Company’s board of directors approved an amendment to the Company’s amended and restated certificate of incorporation to effect a 1-for-2.95 reverse split (“Reverse Split”) of shares of the Company’s common and convertible preferred stock, which was effected on April 20, 2018. The par value and authorized shares of common stock and convertible preferred stock were not adjusted as a result of the Reverse Split. All of the share and per share information included in the accompanying financial statements have been adjusted to reflect the Reverse Split. Accordingly, all share and per share information presented in the condensed financial statements herein, and notes thereto, have been retroactively adjusted to reflect the Reverse Split.
5
The Company has incurred operating losses and has an accumulated deficit as a result of ongoing efforts to develop drug product candidates, including conducting preclinical and clinical trials and providing general and administrative support for these operations. The Company had an accumulated deficit of $123.0 million and $86.9 million as of June 30, 2018 and December 31, 2017, respectively. The Company had net losses of $36.1 million and $20.4 million for the six months ended June 30, 2018 and 2017, respectively, and net cash used in operating activities of $29.9 million and $17.6 million for the six months ended June 30, 2018 and 2017, respectively. To date, none of the Company’s drug candidates have been approved for sale and therefore the Company has not generated any revenue from contracts with customers. The Company has evaluated and concluded there are no conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year following the date that these financial statements are issued. Management expects operating losses to continue for the foreseeable future. As a result, the Company will need to raise additional capital. If sufficient funds on acceptable terms are not available when needed, the Company could be required to significantly reduce its operating expenses and delay, reduce the scope of, or eliminate one or more of its development programs. Failure to manage discretionary spending or raise additional financing, as needed, may adversely impact the Company’s ability to achieve its intended business objectives.
Use of Estimates
The condensed financial statements have been prepared in accordance with GAAP, which requires management to make estimates and assumptions that affect the amounts and disclosures reported in the condensed financial statements and accompanying notes. The Company bases its estimates on historical experience and market-specific or other relevant assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amount of expenses and income reported for each of the periods presented are affected by estimates and assumptions, which are used for, but are not limited to, determining the fair value of assets and liabilities, common stock valuation, contingent consideration and stock-based compensation. Actual results could differ from such estimates or assumptions.
Contingent Consideration Liability
The Company has entered and may continue to enter into license agreements to access and utilize certain technology. In each case, the Company evaluates if the license agreement results in the acquisition of an asset or a business. To date none of the Company’s license agreements have been considered an acquisition of a business. For asset acquisitions, the upfront payments to acquire such licenses, as well as any future milestone payments made before product approval, are immediately recognized as research and development expense when due, provided there is no alternative future use of the rights in other research and development projects. These license agreements also include contingent consideration in the form of additional issuances of the Company’s common stock based on the achievement of certain milestones. For asset acquisitions, the Company assesses whether such contingent consideration meets the definition of a derivative, until such time that the contingency is met or expires. As of June 30, 2018, the Company has recorded a liability related to contingent consideration as the net settlement criteria of the definition of a derivative had been met. The derivative related to this contingent consideration is measured at fair value as of each balance sheet date with the related change in fair value being reflected in operating expenses.
Deferred Offering Costs
Deferred offering costs, consisting of direct incremental legal, accounting, filing and other fees incurred related to the preparation of the IPO, have been capitalized and were offset against proceeds upon completion of the offering in May 2018. As of June 30, 2018, there were no deferred offering costs capitalized and included in current assets on the balance sheet. There were no capitalized deferred offering costs at December 31, 2017.
6
Cash, Cash Equivalents and Restricted Cash
The Company considers all highly liquid investments with original maturities of 90 days or less from the date of purchase to be cash equivalents. Cash equivalents primarily include money market funds that invest in U.S. Treasury obligations which are stated at fair value.
The Company has issued a letter of credit under a lease agreement which has been collateralized. This cash is classified as noncurrent restricted cash on the balance sheet based on the term of the underlying lease.
The following table provides a reconciliation of cash, cash equivalents, and restricted cash within the balance sheets that sum to the total of the same amounts shown in the condensed statements of cash flows (in thousands).
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June 30, 2018 |
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December 31, 2017 |
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Cash and cash equivalents |
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$ |
34,165 |
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$ |
7,298 |
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Restricted cash |
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550 |
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|
550 |
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Total cash, cash equivalents, and restricted cash |
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$ |
34,715 |
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$ |
7,848 |
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Variable Interest Entities
The Company reviews agreements it enters into with third-party entities, pursuant to which the Company may have a variable interest in the entity, in order to determine if the entity is a variable interest entity (“VIE”). If the entity is a VIE, the Company assesses whether or not it is the primary beneficiary of that entity. In determining whether the Company is the primary beneficiary of an entity, the Company applies a qualitative approach that determines whether it has both (i) the power to direct the economically significant activities of the entity and (ii) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. If the Company determines it is the primary beneficiary of a VIE, it consolidates that VIE into the Company’s financial statements. The Company’s determination about whether it should consolidate such VIEs is made continuously as changes to existing relationships or future transactions may result in a consolidation or deconsolidation event.
Concentrations of Risk
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, restricted cash and marketable securities. Substantially all of the Company’s cash and cash equivalents and restricted cash is deposited in accounts with financial institutions that management believes are of high credit quality. Such deposits have and will continue to exceed federally insured limits. The Company maintains its cash with accredited financial institutions and accordingly, such funds are subject to minimal credit risk. The Company has not experienced any losses on its cash deposits. The contribution receivable outstanding as of December 31, 2017 was unsecured and was concentrated with one third-party organization, and accordingly the Company was exposed to credit risk. The Company received the full amount of the contribution receivable in January 2018.
The Company’s investment policy limits investments to certain types of securities issued by the U.S. government, its agencies and institutions with investment-grade credit ratings and places restrictions on maturities and concentration by type and issuer. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents, restricted cash and marketable securities and issuers of marketable securities to the extent recorded on the balance sheets. As of June 30, 2018, the Company had no off-balance sheet concentrations of credit risk.
The Company depends on third-party suppliers for key raw materials used in its manufacturing processes and is subject to certain risks related to the loss of these third-party suppliers or their inability to supply the Company with adequate raw materials.
7
Recently Issued Accounting Pronouncements
In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. This ASU clarifies the definition of a business when evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. The guidance is effective for the Company for fiscal years beginning after December 15, 2018, and interim periods within fiscal years beginning after December 15, 2019. Early adoption is permitted. The Company is currently evaluating the effect that this guidance will have on its financial statements.
In February 2016, the FASB issued ASU No. 2016-02 (“ASU 2016-02”), Leases (Topic 842), which supersedes the guidance in former ASC 840, Leases. The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of their classification. Leases with a term of 12 months or less will be accounted for similar to existing guidance for operating leases today. For the Company, this standard is effective for annual reporting periods beginning after December 15, 2019, and interim periods within annual periods beginning after December 15, 2020. Early adoption is permitted. The ASU is expected to impact the Company’s financial statements as the Company has certain operating lease arrangements for which the Company is the lessee. Management expects that the adoption of this standard will result in the recognition of an asset for the right to use the leased facility on the Company’s balance sheet, as well as the recognition of a liability for the lease payments remaining on the lease. While the Company is currently evaluating the impact of the adoption of this standard on its financial statements, the Company anticipates the recognition of additional assets and corresponding liabilities on its balance sheet related to leases.
In May 2017, the Financial Accounting Standards Board (FASB) issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718)- Scope of Modification Accounting (ASU 2017- 09). The amendments included in this update provide guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting. The amendments in this update will be applied prospectively to an award modified on or after the adoption date. The amendments in ASU 2017-09 became effective for the Company on January 1, 2018 and the adoption of this standard did not have a material impact on the Company’s condensed financial statements.
In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. This guidance makes amendments to the classification and measurement of financial instruments and revises the accounting related to: (1) the classification and measurement of investments in equity securities (except for investments accounted for under the equity method of accounting); and (2) the presentation of certain fair value changes for financial liabilities measured at fair value. In addition, the update also amends certain disclosure requirements associated with the fair value of financial instruments. The guidance is effective for the Company for annual periods beginning in 2019 and interim periods beginning in 2020. Early adoptions of certain amendments within the update are permitted. The Company is currently evaluating the impact that the adoption of this guidance will have on its financial statements and related disclosures, including the Company’s cost method investment.
In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230: Classification of Certain Cash Receipts and Cash Payments). This guidance addresses specific cash flow issues with the objective of reducing the diversity in practice for the treatment of these issues. The areas identified include: debt prepayment or debt extinguishment costs; settlement of zero-coupon debt instruments; contingent consideration payments made after a business combination; proceeds from the settlement of insurance claims; proceeds from the settlement of corporate-owned life insurance policies; distributions received from equity method investees; beneficial interests in securitization transactions; and application of the predominance principle with respect to separately identifiable cash flows. The guidance will generally be applied retrospectively and is effective for fiscal years beginning after December 15, 2018, and interim periods within fiscal years beginning after December 15, 2019. Early adoption is permitted. The Company is currently evaluating the effect that this guidance will have on its financial statements and related disclosures.
8
In June 2018, the FASB issued ASU No. 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. The amendments in this ASU expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. This new guidance is effective for the Company in fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted. The Company is currently assessing the impact of this new guidance.
On December 22, 2017, the U.S. federal government enacted the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act contains, among other things, significant changes to corporate taxation, including reduction of the corporate tax rate from a top marginal rate of 35% to a flat rate of 21% for tax years beginning after December 31, 2017, limitation of the deduction for net operating losses to 80% of current year taxable income and elimination of net operating loss carrybacks, implementing a territorial tax system, and requiring a mandatory one-time tax on U.S. owned undistributed foreign earnings and profits known as the transition tax. In December 2017, SEC staff issued Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act (“SAB 118”) to address the accounting implications of recently enacted U.S. federal tax reform. SAB 118 allows companies to record provisional amounts during a measurement period not to extend beyond one year of the enactment date to address ongoing guidance and tax interpretations that are expected over the next 12 months. The Company has adopted SAB 118 and currently considers its accounting for the impact of U.S. federal tax reform to be incomplete but continues to make a reasonable estimate of the effects on our existing deferred tax assets. The Company expects to complete the remainder of the analysis within the measurement period in accordance with SAB 118. Adjustments, if any, are not expected to impact the statement of operations and comprehensive loss due to the full valuation allowance on the Company’s deferred tax assets.
3. Fair Value Measurements
The Company determines the fair value of financial and non-financial assets and liabilities based on the assumptions that market participants would use in pricing the asset or liability in an orderly transaction between market participants at the measurement date. The identification of market participant assumptions provides a basis for determining what inputs are to be used for pricing each asset or liability. A fair value hierarchy has been established which gives precedence to fair value measurements calculated using observable inputs over those using unobservable inputs. This hierarchy prioritized the inputs into three broad levels as follows:
|
• |
Level 1: Quoted prices in active markets for identical instruments |
|
• |
Level 2: Other significant observable inputs (including quoted prices in active markets for similar instruments) |
|
• |
Level 3: Significant unobservable inputs (including assumptions in determining the fair value of certain investments) |
The carrying amounts of financial instruments such as cash and cash equivalents, restricted cash, contributions receivable, prepaid expenses and other current assets, accounts payable, accrued compensation, accrued and other current liabilities approximate the related fair values due to the short maturities of these instruments.
The fair value of the Company’s cost method investment is measured when it is deemed to be other-than- temporarily impaired.
9
The Company’s financial assets and liabilities subject to fair value measurements on a recurring basis and the level of inputs used in such measurements were as follows (in thousands):
|
|
June 30, 2018 |
|
|||||||||||||
|
|
Total |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
20,142 |
|
|
$ |
20,142 |
|
|
$ |
— |
|
|
$ |
— |
|
U.S. treasuries |
|
|
1,000 |
|
|
|
— |
|
|
|
1,000 |
|
|
|
— |
|
U.S. government debt securities |
|
|
10,887 |
|
|
|
— |
|
|
|
10,887 |
|
|
|
— |
|
Total cash equivalents |
|
|
32,029 |
|
|
|
20,142 |
|
|
|
11,887 |
|
|
|
— |
|
Short-term marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasuries |
|
|
40,077 |
|
|
|
— |
|
|
|
40,077 |
|
|
|
— |
|
U.S. and foreign commercial paper |
|
|
28,481 |
|
|
|
— |
|
|
|
28,481 |
|
|
|
— |
|
U.S. and foreign corporate debt securities |
|
|
17,118 |
|
|
|
— |
|
|
|
17,118 |
|
|
|
— |
|
Asset-backed securities |
|
|
9,865 |
|
|
|
— |
|
|
|
9,865 |
|
|
|
— |
|
U.S. government debt securities |
|
|
56,265 |
|
|
|
— |
|
|
|
56,265 |
|
|
|
— |
|
Total short-term marketable securities |
|
|
151,806 |
|
|
|
— |
|
|
|
151,806 |
|
|
|
— |
|
Long-term marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasuries |
|
|
2,460 |
|
|
|
— |
|
|
|
2,460 |
|
|
|
|
|
U.S. corporate debt securities |
|
|
1,969 |
|
|
|
— |
|
|
|
1,969 |
|
|
|
— |
|
U.S. government debt securities |
|
|
7,644 |
|
|
|
— |
|
|
|
7,644 |
|
|
|
— |
|
Total long-term marketable securities |
|
|
12,073 |
|
|
|
— |
|
|
|
12,073 |
|
|
|
— |
|
Total marketable securities |
|
|
163,879 |
|
|
|
— |
|
|
|
163,879 |
|
|
|
— |
|
Total assets |
|
$ |
195,908 |
|
|
$ |
20,142 |
|
|
$ |
175,766 |
|
|
$ |
— |
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration |
|
|
1,758 |
|
|
|
— |
|
|
|
— |
|
|
|
1,758 |
|
Total contingent consideration |
|
$ |
1,758 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
1,758 |
|
|
|
December 31, 2017 |
|
|||||||||||||
|
|
Total |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Money market funds |
|
$ |
5,709 |
|
|
$ |
5,709 |
|
|
$ |
— |
|
|
$ |
— |
|
Short-term marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. and foreign commercial paper |
|
|
6,359 |
|
|
|
— |
|
|
|
6,359 |
|
|
|
— |
|
U.S. and foreign corporate debt securities |
|
|
16,149 |
|
|
|
— |
|
|
|
16,149 |
|
|
|
— |
|
Asset-backed securities |
|
|
14,588 |
|
|
|
— |
|
|
|
14,588 |
|
|
|
— |
|
U.S. government debt securities |
|
|
40,362 |
|
|
|
— |
|
|
|
40,362 |
|
|
|
— |
|
U.S. treasuries |
|
|
1,754 |
|
|
|
— |
|
|
|
1,754 |
|
|
|
— |
|
Total short-term marketable securities |
|
|
79,212 |
|
|
|
— |
|
|
|
79,212 |
|
|
|
— |
|
Long-term marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asset-backed securities |
|
|
2,742 |
|
|
|
— |
|
|
|
2,742 |
|
|
|
— |
|
U.S. government debt securities |
|
|
2,376 |
|
|
|
— |
|
|
|
2,376 |
|
|
|
— |
|
Total long-term marketable securities |
|
|
5,118 |
|
|
|
— |
|
|
|
5,118 |
|
|
|
— |
|
Total marketable securities |
|
|
84,330 |
|
|
|
— |
|
|
|
84,330 |
|
|
|
— |
|
Total |
|
$ |
90,039 |
|
|
$ |
5,709 |
|
|
$ |
84,330 |
|
|
$ |
— |
|
10
The Company estimates the fair value of its money market funds, U.S. and foreign commercial paper, U.S. and foreign corporate debt securities, asset-backed securities, U.S. treasuries and U.S. government debt securities by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads; benchmark securities; prepayment/default projections based on historical data; and other observable inputs.
The fair value of the contingent consideration liability includes inputs not observable in the market and thus represents a Level 3 measurement. The Company has recorded a contingent consideration liability related to two agreements executed in February 2016 with a privately held clinical-stage biopharmaceutical company: (a) a license agreement granting the Company the right to research, develop, and seek and obtain marketing approval for an initial licensed compound, and (b) a compound library and option agreement granting the Company the right to identify and take licenses to additional compounds, in each case for the treatment of indications outside of oncology (collectively, the “Commercial Agreements”). The Commercial Agreements include contingent consideration of up to 666,670 additional shares of common stock to be issued based on achievement of certain specified clinical development and sales milestone events. The Company valued the contingent consideration liability using a probability-weighted valuation approach model which reflects the probability and timing of future issuances of shares. The probability of achieving the defined milestones for each licensed product was estimated by the Company’s management. Total contingent consideration may change significantly as development under the Commercial Agreements progresses and additional data is obtained, impacting the Company’s assumptions regarding probabilities of successful achievement of related development and commercial milestones used to estimate the fair value of the liability and the timing in which they are expected to be achieved. For example, significant increases in the estimated probability of achieving a milestone would result in a significantly higher fair value measurement while significant decreases in the estimated probability of achieving a milestone would result in a significantly lower fair value measurement. The potential contingent consideration value resulting in shares to be issued range from zero if none of the milestones are achieved to a maximum of $11.1 million (using the Company’s stock price as of June 30, 2018). As of June 30, 2018, and December 31, 2017, none of the development and commercial milestones had been achieved and no royalties were due from the sales of licensed products.
The following table provides a reconciliation of assets and liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the six months ended June 30, 2018 (in thousands):
|
|
Amount |
|
|
Balance at December 31, 2017 |
|
$ |
— |
|
Additions |
|
|
— |
|
Settlements |
|
|
— |
|
Change in fair value |
|
|
1,758 |
|
Balance at June 30, 2018 |
|
$ |
1,758 |
|
There were no transfers between the hierarchies during the six months ended June 30, 2018 and the year ended December 31, 2017.
11
Marketable securities, which are classified as available-for-sale, consisted of the following as of June 30, 2018 (in thousands):
|
|
June 30, 2018 |
|
|||||||||||||
|
|
Amortized Cost Basis |
|
|
Unrealized Gains |
|
|
Unrealized Losses |
|
|
Fair Value |
|
||||
Short-term marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. and foreign commercial paper |
|
$ |
28,487 |
|
|
$ |
3 |
|
|
$ |
(9 |
) |
|
$ |
28,481 |
|
U.S. and foreign corporate debt securities |
|
|
17,142 |
|
|
|
— |
|
|
|
(24 |
) |
|
|
17,118 |
|
Asset-backed securities |
|
|
9,885 |
|
|
|
— |
|
|
|
(20 |
) |
|
|
9,865 |
|
U.S. government debt securities |
|
|
56,290 |
|
|
|
3 |
|
|
|
(28 |
) |
|
|
56,265 |
|
U.S. treasuries |
|
|
40,078 |
|
|
|
1 |
|
|
|
(2 |
) |
|
|
40,077 |
|
Total short-term marketable securities |
|
|
151,882 |
|
|
|
7 |
|
|
|
(83 |
) |
|
|
151,806 |
|
Long-term marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. corporate debt securities |
|
|
1,970 |
|
|
|
— |
|
|
|
(1 |
) |
|
|
1,969 |
|
U.S. government debt securities |
|
|
7,644 |
|
|
|
1 |
|
|
|
(1 |
) |
|
|
7,644 |
|
U.S. treasuries |
|
|
2,460 |
|
|
|
— |
|
|
|
— |
|
|
|
2,460 |
|
Total long-term marketable securities |
|
|
12,074 |
|
|
|
1 |
|
|
|
(2 |
) |
|
|
12,073 |
|
Total marketable securities |
|
$ |
163,956 |
|
|
$ |
8 |
|
|
$ |
(85 |
) |
|
$ |
163,879 |
|
Marketable securities, which are classified as available-for-sale, consisted of the following as of December 31, 2017:
|
|
December 31, 2017 |
|
|||||||||||||
|
|
Amortized Cost Basis |
|
|
Unrealized Gains |
|
|
Unrealized Losses |
|
|
Fair Value |
|
||||
Short-term marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. and foreign commercial paper |
|
$ |
6,369 |
|
|
$ |
— |
|
|
$ |
(10 |
) |
|
$ |
6,359 |
|
U.S. and foreign corporate debt securities |
|
|
16,162 |
|
|
|
— |
|
|
|
(13 |
) |
|
|
16,149 |
|
Asset-backed securities |
|
|
14,604 |
|
|
|
— |
|
|
|
(16 |
) |
|
|
14,588 |
|
U.S. government debt securities |
|
|
40,418 |
|
|
|
— |
|
|
|
(56 |
) |
|
|
40,362 |
|
U.S. treasuries |
|
|
1,754 |
|
|
|
— |
|
|
|
— |
|
|
|
1,754 |
|
Total short-term marketable securities |
|
|
79,307 |
|
|
|
— |
|
|
|
(95 |
) |
|
|
79,212 |
|
Long-term marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asset-backed securities |
|
|
2,752 |
|
|
|
— |
|
|
|
(10 |
) |
|
|
2,742 |
|
U.S. government debt securities |
|
|
2,375 |
|
|
|
1 |
|
|
|
— |
|
|
|
2,376 |
|
Total long-term marketable securities |
|
|
5,127 |
|
|
|
1 |
|
|
|
(10 |
) |
|
|
5,118 |
|
Total marketable securities |
|
$ |
84,434 |
|
|
$ |
1 |
|
|
$ |
(105 |
) |
|
$ |
84,330 |
|
At June 30, 2018, the remaining contractual maturities of available-for-sale securities were less than two years. There have been no significant realized gains or losses on available-for-sale securities for the periods presented. Available-for-sale debt securities that were in a continuous loss position but were not deemed to be other than temporarily impaired were immaterial at both June 30, 2018 and December 31, 2017.
12
License and Compound Library and Option Agreement
The Commercial Agreements referenced above include cash payments of up to $70.3 million as well as the equity payments of up to 666,670 additional shares of common stock, in each case to be issued based on the Company’s achievement of certain specified clinical development and sales milestone events. The license agreement also includes tiered royalties in the low-single digits based on sales of licensed products.
The Company recognized a $1.8 million contingent consideration liability associated with the potential issuance of common stock related to the Commercial Agreements with the privately held clinical-stage biopharmaceutical company for the three months ended June 30, 2018.
In connection with the Commercial Agreements the Company purchased an equity interest in an affiliate of the biopharmaceutical company for an aggregate purchase price of $0.5 million. The equity interest represents an insignificant level of ownership in the entity and approximates the fair value of the shares received and has been recorded as a cost method investment in the Company’s financial statements. In May 2018 these shares were exchanged for new shares of a newly formed affiliate of the biopharmaceutical company as part of a reorganization of those entities. The Company also invested an additional $0.5 million in the biopharmaceutical company in May 2018.
The Company agreed to provide funding to the biopharmaceutical company for research and development work performed at a cost of up to $2.0 million through February 2020. The research and development expense under the research services agreement was $0.3 million for the six months ended June 30, 2018 and 2017.
Under the consolidation guidance, the Company determined that the biopharmaceutical company is a VIE. The Company does not have the power to direct the activities that most significantly affect the economic performance of this entity and as such the Company is not the primary beneficiary and consolidation is not required. As of June 30, 2018, and December 31, 2017, the Company has not provided financial, or other, support to the biopharmaceutical company that was not contractually required.
Other License Agreements with Research Institutions
The Company has entered into license agreements with various research institutions which have provided the Company with rights to patents, and in certain cases, research “know-how” and proprietary research tools to research, develop and commercialize drug candidates. In addition to upfront consideration paid to these various research institutions in either cash or shares of the Company’s common stock, the Company may be obligated to pay milestone payments in cash or the issuance of the Company’s common stock specific to each agreement upon achievement of certain specified clinical development and/or sales events. The contingent consideration liability considered to be a derivative associated with the potential issuance of common stock related to these license agreements was not significant at June 30, 2018. To date, none of these events has occurred and no contingent consideration, milestone or royalty payments have been recognized.
13
6. Commitments and Contingencies
Operating Lease
The Company has one non-cancelable operating lease consisting of administrative and research and development office space for its Brisbane, California headquarters that expires in October 2022. Future minimum lease payments under our non-cancellable operating lease at June 30, 2018 were as follows (in thousands):
|
|
|
|
|
|
|
Amount |
|
|
2018 (remaining 6 months) |
|
$ |
984 |
|
2019 |
|
|
2,012 |
|
2020 |
|
|
2,072 |
|
2021 |
|
|
2,135 |
|
2022 |
|
|
1,621 |
|
Total future minimum lease payments |
|
$ |
8,824 |
|
Rent expense for the six months ended June 30, 2018 and 2017 was $0.9 million and $0.8 million, respectively.
Indemnifications
The Company indemnifies each of its officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at the Company’s request in such capacity, as permitted under Delaware law and in accordance with the Company’s amended and restated certificate of incorporation and bylaws. The term of the indemnification period lasts as long as an officer or director may be subject to any proceeding arising out of acts or omissions of such officer or director in such capacity.
The maximum amount of potential future indemnification is unlimited; however, the Company currently holds director and officer liability insurance. The Company believes that the fair value of these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to these obligations for any period presented.
7. Related-Party Transactions
Recourse Notes
In December 2015, April 2016, and July 2016, the Company issued three full-recourse promissory notes to two executive officers for an aggregate principal amount of $0.2 million with an interest rate of 2.5% per annum. All of the principal was used to early exercise options for 667,253 shares of the Company’s common stock, in aggregate. All of these related party full-recourse notes were repaid on April 4, 2018 in accordance with the terms of such notes.
In October 2017, the Company issued two promissory notes to an executive officer for $1.6 million and $0.5 million, each with an interest rate of 1.85% per annum. The aggregate principal amount of $2.1 million was used to purchase 625,084 shares of restricted stock. The promissory notes were considered to be non-recourse in substance and accordingly, the shares sold subject to such promissory notes are considered an option for accounting purposes. In April 2018, the Company’s board of directors approved the forgiveness of all outstanding principal and accrued interest of the $1.6 million non-recourse promissory note. The non-recourse promissory note outstanding of $0.5 million was repaid on April 4, 2018 in accordance with the terms of the note. The forgiveness of the promissory note was accounted for as a modification of a share-based payment. The Company recorded an incremental $0.8 million charge related to the modification for the three and six months ended June 30, 2018.
14
In January 2018, the Company issued full-recourse promissory notes to an executive and an executive officer of the Company for an aggregate principal amount of $0.4 million with an interest rate of 2.5% per annum. All of the principal was used to early exercise options for 114,406 shares of the Company’s common stock. The full recourse note of $0.2 million for the executive officer was repaid on April 4, 2018 in accordance with the terms of the note.
Financing Activities
During the six months ended June 30, 2018, the Company issued convertible preferred stock for total proceeds of $3.0 million to shareholders who are considered to be related parties.
8. Convertible Preferred Stock and Common Stock
Convertible Preferred Stock
In March 2018, the Company amended and restated its certificate of incorporation to, among other things, (i) increase its authorized shares of common stock from 122,000,000 to 140,000,000 shares, (ii) increase its authorized shares of preferred stock from 91,739,149 to 103,283,818 shares, of which 11,544,669 shares were designated as Series C convertible preferred stock, and (iii) set forth the rights, preferences and privileges of the Series C convertible preferred stock. In March 2018, the Company sold 3,590,573 shares of Series C convertible preferred stock at $15.3317 per share for net proceeds of $54.9 million and in April 2018, the Company sold an additional 322,852 shares of Series C convertible preferred stock $15.3317 per share for net proceeds of $5.0 million.
Each share of Series C convertible preferred stock was convertible into one share of the Company’s common stock. Each share of preferred stock was automatically converted into one share of common stock upon the consummation of a qualified public offering. A qualified public offering was defined as an initial public offering that resulted in listing on a U.S. national securities exchange and at least $30.0 million of gross proceeds at a per share price of not less than the Series C original issue price of $15.3317.
The Company evaluated the other rights, preferences and privileges of each series of convertible preferred stock and concluded that there were no freestanding derivative instruments or any embedded derivatives requiring bifurcation.
Upon the closing of the IPO, all of the Company’s outstanding shares of convertible preferred stock were converted into 32,073,149 shares of common stock. In addition, all 763,501 of the Company’s convertible preferred stock warrants were converted into warrants to purchase shares of common stock. As of June 30, 2018, the Company had no remaining shares of convertible or preferred stock issued or outstanding.
As of December 31, 2017, convertible preferred stock consisted of the following (in thousands, except share amounts):
|
|
Shares Authorized |
|
|
Shares Issued and Outstanding |
|
|
Liquidation Preference |
|
|
Carrying Value |
|
||||
Series A-1 |
|
|
9,085,738 |
|
|
|
2,887,086 |
|
|
$ |
2,495 |
|
|
$ |
2,457 |
|
Series A-2 |
|
|
32,653,411 |
|
|
|
10,498,269 |
|
|
|
9,198 |
|
|
|
9,214 |
|
Series B |
|
|
50,000,000 |
|
|
|
14,774,369 |
|
|
|
179,132 |
|
|
|
162,285 |
|
Total convertible preferred stock |
|
|
91,739,149 |
|
|
|
28,159,724 |
|
|
$ |
190,825 |
|