UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2017
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 001-32157
Savara Inc.
(Exact name of registrant as specified in its charter)
Delaware |
|
84-1318182 |
(State or other jurisdiction of incorporation or organization) |
|
(I.R.S. Employer Identification No.) |
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|
900 South Capital of Texas Highway, Las Cimas IV, Suite 150 Austin, TX |
|
78746 |
(Address of principal executive offices) |
|
(Zip Code) |
(512) 961-1891
(Registrant’s telephone number, including area code)
N/A
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 |
|
☐ |
|
Accelerated filer |
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☒ |
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|||
Non-accelerated filer |
|
☐ |
|
Smaller reporting company |
|
☐ |
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|
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|
Emerging growth company |
|
☐ |
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|
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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 November 8, 2017, the registrant had 30,500,693 shares of common stock, $0.001 par value per share, outstanding.
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Page |
PART I. |
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Item 1. |
1 |
|
|
1 |
|
|
Condensed Consolidated Statements of Operations and Comprehensive Loss |
2 |
|
3 |
|
|
4 |
|
|
5 |
|
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
25 |
Item 3. |
33 |
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Item 4. |
34 |
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PART II. |
|
|
Item 1. |
35 |
|
Item 1A. |
35 |
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Item 2. |
56 |
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Item 3. |
56 |
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Item 4. |
56 |
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Item 5. |
56 |
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Item 6. |
56 |
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57 |
||
58 |
i
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
|
|
September 30, 2017 |
|
|
December 31, 2016 |
|
||
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
19,813 |
|
|
$ |
13,373 |
|
Short-term investments |
|
|
33,473 |
|
|
|
— |
|
Grants and award receivable |
|
|
— |
|
|
|
400 |
|
Prepaid expenses and other current assets |
|
|
2,235 |
|
|
|
840 |
|
Total current assets |
|
|
55,521 |
|
|
|
14,613 |
|
Property and equipment, net |
|
|
582 |
|
|
|
793 |
|
In-process R&D |
|
|
33,449 |
|
|
|
10,477 |
|
Goodwill |
|
|
28,332 |
|
|
|
3,051 |
|
Other non-current assets |
|
|
1,004 |
|
|
|
— |
|
Total assets |
|
$ |
118,888 |
|
|
$ |
28,934 |
|
Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,665 |
|
|
$ |
536 |
|
Accrued expenses |
|
|
4,147 |
|
|
|
2,477 |
|
Current portion of capital lease obligation |
|
|
265 |
|
|
|
442 |
|
Total current liabilities |
|
|
6,077 |
|
|
|
3,455 |
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
Accrued interest on convertible promissory notes |
|
|
— |
|
|
|
151 |
|
Debt facility |
|
|
14,675 |
|
|
|
— |
|
Convertible promissory notes |
|
|
— |
|
|
|
3,448 |
|
Put option derivative liability |
|
|
— |
|
|
|
979 |
|
Contingent consideration |
|
|
11,816 |
|
|
|
9,708 |
|
Deferred tax liability |
|
|
11,263 |
|
|
|
2,305 |
|
Capital lease obligation, net of current portion |
|
|
297 |
|
|
|
579 |
|
Warrant liability |
|
|
— |
|
|
|
303 |
|
Other long-term liabilities |
|
|
115 |
|
|
|
20 |
|
Total liabilities |
|
|
44,243 |
|
|
|
20,948 |
|
Redeemable convertible preferred stock: |
|
|
|
|
|
|
|
|
Series A redeemable convertible preferred stock, $0.001 par value, 0 and 1,799,906 shares authorized, issued, and outstanding, as of September 30, 2017 and December 31, 2016, respectively |
|
|
— |
|
|
|
3,232 |
|
Series B redeemable convertible preferred stock, $0.001 par value, 0 and 6,000,000 shares authorized as of September 30, 2017 and December 31, 2016, respectively; 0 and 5,675,387 shares issued and outstanding as of September 30, 2017 and December 31, 2016; respectively |
|
|
— |
|
|
|
17,301 |
|
Series C redeemable convertible preferred stock, $0.001 par value; 0 and 8,000,000 shares authorized as of September 30, 2017 and December 31, 2016, respectively; 0 and 4,452,582 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively |
|
|
— |
|
|
|
23,328 |
|
Total redeemable convertible preferred stock |
|
|
— |
|
|
|
43,861 |
|
Stockholders’ equity (deficit): |
|
|
|
|
|
|
|
|
Common stock, $0.001 par value, 500,000,000 and 27,000,000 shares authorized as of September 30, 2017 and December 31, 2016, respectively; 24,389,105 and 3,162,573 shares (after giving effect to the Exchange Ratio and Reverse Stock Split) issued and outstanding as of September 30, 2017 and December 31, 2016, respectively |
|
|
26 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
135,571 |
|
|
|
3,117 |
|
Accumulated other comprehensive income (loss) |
|
|
747 |
|
|
|
(591 |
) |
Accumulated deficit |
|
|
(61,699 |
) |
|
|
(38,406 |
) |
Total stockholders’ equity (deficit) |
|
|
74,645 |
|
|
|
(35,875 |
) |
Total liabilities, redeemable convertible preferred stock, and stockholder’s equity (deficit) |
|
$ |
118,888 |
|
|
$ |
28,934 |
|
The accompanying notes are an integral part of these financial statements.
1
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
||||
Grant and award revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
4,966 |
|
|
|
2,142 |
|
|
|
12,076 |
|
|
|
4,694 |
|
General and administrative |
|
|
1,486 |
|
|
|
1,002 |
|
|
|
8,410 |
|
|
|
1,955 |
|
Depreciation |
|
|
91 |
|
|
|
86 |
|
|
|
272 |
|
|
|
256 |
|
Total operating expenses |
|
|
6,543 |
|
|
|
3,230 |
|
|
|
20,758 |
|
|
|
6,905 |
|
Loss from operations |
|
|
(6,543 |
) |
|
|
(3,230 |
) |
|
|
(20,758 |
) |
|
|
(6,905 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(277 |
) |
|
|
(190 |
) |
|
|
(1,038 |
) |
|
|
(207 |
) |
Foreign currency exchange gain (loss) |
|
|
(71 |
) |
|
|
92 |
|
|
|
(225 |
) |
|
|
20 |
|
Loss on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
(1,816 |
) |
|
|
— |
|
Change in fair value of financial instruments |
|
|
(43 |
) |
|
|
101 |
|
|
|
(280 |
) |
|
|
137 |
|
Total other income (expense) |
|
|
(391 |
) |
|
|
3 |
|
|
|
(3,359 |
) |
|
|
(50 |
) |
Loss before income taxes |
|
|
(6,934 |
) |
|
|
(3,227 |
) |
|
|
(24,117 |
) |
|
|
(6,955 |
) |
Income tax benefit |
|
|
117 |
|
|
|
— |
|
|
|
824 |
|
|
|
— |
|
Net loss |
|
$ |
(6,817 |
) |
|
$ |
(3,227 |
) |
|
$ |
(23,293 |
) |
|
$ |
(6,955 |
) |
Accretion of redeemable convertible preferred stock |
|
|
— |
|
|
|
(44 |
) |
|
|
(578 |
) |
|
|
(70 |
) |
Deemed dividend on beneficial conversion feature |
|
|
— |
|
|
|
— |
|
|
|
(404 |
) |
|
|
— |
|
Net loss attributable to common stockholders |
|
$ |
(6,817 |
) |
|
$ |
(3,271 |
) |
|
$ |
(24,275 |
) |
|
$ |
(7,025 |
) |
Other comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) on foreign currency translation |
|
|
348 |
|
|
|
39 |
|
|
|
1,343 |
|
|
|
39 |
|
Unealized gain (loss) on short-term investments |
|
|
(5 |
) |
|
|
— |
|
|
|
(5 |
) |
|
|
— |
|
Total Comprehensive Loss |
|
$ |
(6,474 |
) |
|
$ |
(3,188 |
) |
|
$ |
(21,955 |
) |
|
$ |
(6,916 |
) |
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.28 |
) |
|
$ |
(1.21 |
) |
|
$ |
(1.76 |
) |
|
$ |
(4.40 |
) |
Weighted average common shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
24,209,517 |
|
|
|
2,707,055 |
|
|
|
13,770,032 |
|
|
|
1,596,123 |
|
The accompanying notes are an integral part of these financial statements.
2
Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Period Ended September 30, 2017
(In thousands, except share amounts)
(Unaudited)
|
Redeemable Convertible Preferred Stock |
|
|
|
|
|
|
Stockholders’ Equity (Deficit) |
|
||||||||||||||||||||||||||||||||||||||||||
|
Redeemable Convertible Series A Preferred Stock |
|
|
Redeemable Convertible Series B Preferred Stock |
|
|
Redeemable Convertible Series C Preferred Stock |
|
|
|
|
|
|
Common Stock |
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|||||||||||||||||||||||||
|
Number of Shares |
|
|
Amount |
|
|
Number of Shares |
|
|
Amount |
|
|
Number of Shares |
|
|
Amount |
|
|
Total |
|
|
Number of Shares |
|
|
Amount |
|
|
Additional Paid-In Capital |
|
|
Accumulated Deficit |
|
|
Other Comprehensive Income |
|
|
Total |
|
|||||||||||||
Balance on December 31, 2016 |
|
1,799,906 |
|
|
$ |
3,232 |
|
|
|
5,675,387 |
|
|
$ |
17,301 |
|
|
|
4,452,582 |
|
|
$ |
23,328 |
|
|
$ |
43,861 |
|
|
|
3,162,573 |
|
|
$ |
5 |
|
|
$ |
3,117 |
|
|
$ |
(38,406 |
) |
|
$ |
(591 |
) |
|
$ |
(35,875 |
) |
Repurchase of forfeited restricted common stock |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(19,045 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|||||
Accretion of redeemable convertible preferred stock |
|
— |
|
|
|
22 |
|
|
|
— |
|
|
|
460 |
|
|
|
— |
|
|
|
96 |
|
|
|
578 |
|
|
|
— |
|
|
— |
|
|
|
(578 |
) |
|
— |
|
|
— |
|
|
|
(578 |
) |
|||
Issuance of common stock upon exercise of warrants |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
111,799 |
|
|
|
— |
|
|
|
384 |
|
|
— |
|
|
— |
|
|
|
384 |
|
||
Conversion of convertible notes into common stock |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,140,046 |
|
|
|
1 |
|
|
|
10,044 |
|
|
— |
|
|
— |
|
|
|
10,045 |
|
||
Conversion of redeemable convertible preferred stock to common stock as effected for the reverse merger exchange ratio |
|
(1,799,906 |
) |
|
|
(3,254 |
) |
|
|
(5,675,387 |
) |
|
|
(17,761 |
) |
|
|
(4,452,582 |
) |
|
|
(23,424 |
) |
|
|
(44,439 |
) |
|
|
7,034,102 |
|
|
|
7 |
|
|
|
44,431 |
|
|
— |
|
|
— |
|
|
|
44,438 |
|
||
Reclassification of warrant liability |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
370 |
|
|
— |
|
|
— |
|
|
|
370 |
|
|||
Beneficial conversion feature |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
404 |
|
|
— |
|
|
— |
|
|
|
404 |
|
|||
Business combination upon Merger |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
3,639,189 |
|
|
|
4 |
|
|
|
35,842 |
|
|
— |
|
|
— |
|
|
|
35,846 |
|
||
Issuance of common stock upon public offering, net closing costs |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
9,034,210 |
|
|
|
9 |
|
|
|
39,513 |
|
|
— |
|
|
— |
|
|
|
39,522 |
|
||
Issuance of detachable warrants with debt instrument |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
— |
|
|
|
359 |
|
|
— |
|
|
— |
|
|
|
359 |
|
|||
Issuance of common stock upon At The Market sales, net |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
124,210 |
|
|
|
— |
|
|
|
991 |
|
|
— |
|
|
— |
|
|
|
991 |
|
||
Issuance of common stock for settlement of RSUs |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
72,361 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Issuance of common stock upon cashless exercise of stock options |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
89,660 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Issuance of call option derivative |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
- |
|
|
|
— |
|
|
|
344 |
|
|
|
— |
|
|
|
— |
|
|
|
344 |
|
Stock-based compensation |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
350 |
|
|
|
— |
|
|
|
— |
|
|
|
350 |
|
Foreign exchange translation adjustment |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,343 |
|
|
|
1,343 |
|
Unrealized gain (loss) on short-term investments |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(5 |
) |
|
|
(5 |
) |
Net loss incurred |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(23,293 |
) |
|
|
— |
|
|
|
(23,293 |
) |
Balance on September 30, 2017 |
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
|
24,389,105 |
|
|
$ |
26 |
|
|
$ |
135,571 |
|
|
$ |
(61,699 |
) |
|
$ |
747 |
|
|
$ |
74,645 |
|
The accompanying notes are an integral part of these financial statements.
3
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2017 |
|
|
2016 |
|
||
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(23,293 |
) |
|
$ |
(6,955 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
272 |
|
|
|
256 |
|
Changes in fair value of financial instruments |
|
|
280 |
|
|
|
(137 |
) |
Change in fair value of contingent consideration |
|
|
2,108 |
|
|
|
— |
|
Noncash interest |
|
|
395 |
|
|
|
99 |
|
Loss on extinguishment of debt |
|
|
1,816 |
|
|
|
— |
|
Foreign currency gain/(loss) |
|
|
225 |
|
|
|
(20 |
) |
Accretion on discount to convertible promissory notes |
|
|
— |
|
|
|
121 |
|
Amortization of debt issuance costs |
|
|
301 |
|
|
|
— |
|
Accretion on discount to short-term investments |
|
|
(34 |
) |
|
|
— |
|
Stock-based compensation |
|
|
350 |
|
|
|
154 |
|
Issuance of call option derivative |
|
|
344 |
|
|
|
— |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Grant and award receivable |
|
|
400 |
|
|
|
— |
|
Tax refund receivable |
|
|
(785 |
) |
|
|
— |
|
Prepaid expenses and other current assets |
|
|
(1,272 |
) |
|
|
(479 |
) |
Deferred rent |
|
|
(14 |
) |
|
|
15 |
|
Accounts payable and accrued expenses |
|
|
143 |
|
|
|
766 |
|
Net cash used in operating activities |
|
$ |
(18,764 |
) |
|
$ |
(6,180 |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Cash acquired through Merger |
|
$ |
3,442 |
|
|
$ |
— |
|
Purchase of property and equipment |
|
|
(61 |
) |
|
|
(8 |
) |
Purchase of available-for-sale securities |
|
|
(33,443 |
) |
|
|
— |
|
Net cash used in investing activities |
|
$ |
(30,062 |
) |
|
$ |
(8 |
) |
Cash flows from financing activity: |
|
|
|
|
|
|
|
|
Proceeds from debt facility |
|
$ |
14,894 |
|
|
$ |
— |
|
Proceeds from convertible promissory note |
|
|
3,569 |
|
|
|
4,315 |
|
Issuance of common stock upon exercise of warrants |
|
|
384 |
|
|
|
— |
|
Issuance of common stock upon public offering, net |
|
|
39,522 |
|
|
|
— |
|
Repayment of long-term debt |
|
|
(3,567 |
) |
|
|
— |
|
Issuance of common stock upon at the market offerings, net |
|
|
991 |
|
|
|
— |
|
Proceeds from exercise of stock option |
|
|
— |
|
|
|
1 |
|
Proceeds from issuance of Series C preferred stock, net |
|
|
— |
|
|
|
782 |
|
Capital lease obligation principal payments |
|
|
(460 |
) |
|
|
(81 |
) |
Net cash provided by financing activities |
|
$ |
55,333 |
|
|
$ |
5,017 |
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
(67 |
) |
|
|
— |
|
Increase / (Decrease) in cash and cash equivalents |
|
$ |
6,440 |
|
|
$ |
(1,171 |
) |
Cash and cash equivalents beginning of period |
|
|
13,373 |
|
|
|
16,683 |
|
Cash and cash equivalents end of period |
|
$ |
19,813 |
|
|
$ |
15,512 |
|
|
|
|
|
|
|
|
|
|
Non-cash transactions: |
|
|
|
|
|
|
|
|
Issuance of common stock for Serendex |
|
$ |
— |
|
|
$ |
2,851 |
|
Net assets acquired in business combination of Serendex |
|
|
— |
|
|
|
(12,375 |
) |
Contingent liability related to purchase of Serendex |
|
|
— |
|
|
|
9,524 |
|
Extinguishment and derecognition of put options |
|
|
2,202 |
|
|
|
— |
|
Conversion of convertible notes into common stock |
|