Document And Entity Information
Document And Entity Information | 9 Months Ended |
Sep. 30, 2019 | |
Document Information [Line Items] | |
Entity Registrant Name | PROTEON THERAPEUTICS INC |
Entity Central Index Key | 0001359931 |
Entity Filer Category | Non-accelerated Filer |
Entity Emerging Growth Company | true |
Entity Small Business | true |
Document Type | S-4/A |
Document Period End Date | Sep. 30, 2019 |
Amendment Flag | false |
Entity Ex Transition Period | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 19,371,000 | $ 21,170,000 |
Available-for-sale investments | 2,496,000 | 20,971,000 |
Prepaid expenses and other current assets | 1,369,000 | 1,339,000 |
Total current assets | 23,236,000 | 43,480,000 |
Property and equipment, net | 263,000 | 259,000 |
Restricted cash | 22,000 | 22,000 |
Other non-current assets | 218,000 | |
Total assets | 23,521,000 | 43,979,000 |
Current liabilities: | ||
Accounts payable | 441,000 | 291,000 |
Accrued expenses | 2,637,000 | 8,949,000 |
Total current liabilities | 3,078,000 | 9,240,000 |
Total liabilities | 3,078,000 | 9,240,000 |
Commitments and contingencies (Note 5) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value per share; 10,000,000 shares authorized at September 30, 2019 and December 31, 2018: Series A convertible preferred stock 22,000 shares authorized at September 30, 2019 and December 31, 2018; 21,660 and 22,000 issued and outstanding at September 30, 2019 and at December 31, 2018, respectively | ||
Common stock, $0.001 par value, 100,000,000 shares authorized at September 30, 2019 and December 31, 2018; 19,585,394 and 19,243,651 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 19,000 | 18,000 |
Additional paid-in capital | 209,366,000 | 202,953,000 |
Accumulated deficit | (210,470,000) | (189,741,000) |
Accumulated other comprehensive income | 5,000 | (14,000) |
Total stockholders’ equity | 20,443,000 | 34,739,000 |
Total liabilities and stockholders’ equity | 23,521,000 | 43,979,000 |
Series A Convertible Preferred Stock [Member] | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value per share; 10,000,000 shares authorized at September 30, 2019 and December 31, 2018: Series A convertible preferred stock 22,000 shares authorized at September 30, 2019 and December 31, 2018; 21,660 and 22,000 issued and outstanding at September 30, 2019 and at December 31, 2018, respectively | $ 21,523,000 | $ 21,523,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Aug. 02, 2017 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | 10,000,000 | |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 | 100,000,000 | |
Common stock, shares issued (in shares) | 19,585,394 | 19,243,651 | 17,674,729 | |
Common stock, shares outstanding (in shares) | 19,585,394 | 19,243,651 | 17,674,729 | |
Series A Convertible Preferred Stock [Member] | ||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |
Preferred stock, shares authorized (in shares) | 22,000 | 22,000 | 22,000 | |
Preferred stock, shares issued (in shares) | 21,660 | 22,000 | 22,000 | |
Preferred stock, shares outstanding (in shares) | 21,660 | 22,000 | 22,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating expenses: | |||
Research and development | $ 11,848 | $ 21,686 | $ 18,869 |
General and administrative | 9,524 | 8,676 | 9,836 |
Total operating expenses | 21,372 | 30,362 | 28,705 |
Loss from operations | (21,372) | (30,362) | (28,705) |
Other income: | |||
Investment income | 436 | 259 | 193 |
Other income (expense), net | 207 | 139 | (14) |
Total other income | 643 | 398 | 179 |
Net loss | (20,729) | (29,964) | (28,526) |
Foreign currency translation adjustment | (1) | 6 | |
Unrealized gain on available-for-sale investments | 20 | (20) | 11 |
Comprehensive loss | (20,710) | (29,978) | (28,515) |
Reconciliation of net loss to net loss attributable to common stockholders: | |||
Net loss | (20,729) | (29,964) | (28,526) |
Accretion of convertible preferred stock to redemption value | (6,747) | ||
Net loss attributable to common stockholders | $ (20,729) | $ (36,711) | $ (28,526) |
Net loss per share attributable to common stockholders - basic and diluted (in dollars per share) | $ (1.15) | $ (2.13) | $ (1.72) |
Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted (in shares) | 18,102,219 | 17,274,326 | 16,561,799 |
Included in operating expenses, above, are the following amounts for non-cash stock-based compensation expense: | |||
Allocated share-based compensation | $ 3,429 | $ 3,227 | $ 3,343 |
Research and Development Expense [Member] | |||
Included in operating expenses, above, are the following amounts for non-cash stock-based compensation expense: | |||
Allocated share-based compensation | 1,142 | 1,109 | 1,114 |
General and Administrative Expense [Member] | |||
Included in operating expenses, above, are the following amounts for non-cash stock-based compensation expense: | |||
Allocated share-based compensation | $ 2,287 | $ 2,118 | $ 2,229 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) $ in Thousands | Series A Preferred Stock [Member]Preferred Stock [Member] | Series A Preferred Stock [Member]Additional Paid-in Capital [Member] | Series A Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Balance (in shares) at Dec. 31, 2015 | 16,501,500 | |||||||
Balance at Dec. 31, 2015 | $ 16 | $ 194,651 | $ (131,251) | $ (11) | $ 63,405 | |||
us-gaap_StockIssuedDuringPeriodSharesStockOptionsExercised | 97,521 | |||||||
Exercise of common stock options | $ 1 | 196 | 197 | |||||
Issuance of common stock upon ESPP purchase (in shares) | 4,538 | |||||||
Issuance of common stock upon ESPP purchase | 11 | 11 | ||||||
Stock-based compensation expense | 3,343 | 3,343 | ||||||
Unrealized gain on available-for-sale investments | 11 | 11 | ||||||
Net loss | (28,526) | (28,526) | ||||||
Balance (in shares) at Dec. 31, 2016 | 16,603,559 | |||||||
Balance at Dec. 31, 2016 | $ 17 | 198,201 | (159,777) | 38,441 | ||||
us-gaap_StockIssuedDuringPeriodSharesStockOptionsExercised | 74,001 | |||||||
Exercise of common stock options | 108 | 108 | ||||||
Issuance of common stock upon ESPP purchase (in shares) | 100,358 | |||||||
Issuance of common stock upon ESPP purchase | 130 | 130 | ||||||
Stock-based compensation expense | 3,227 | 3,227 | ||||||
Unrealized gain on available-for-sale investments | (20) | |||||||
Net loss | (29,964) | (29,964) | ||||||
Issuance of common stock, net of issuance costs (in shares) | 22,000 | 896,811 | ||||||
Issuance of common stock, net of issuance costs | $ 14,776 | $ 6,747 | $ 21,523 | $ 1 | 1,287 | 1,288 | ||
Accretion of Series A Convertible Preferred Stock | $ 6,747 | (6,747) | ||||||
Other comprehensive gain/(loss) | (14) | (14) | ||||||
Balance (in shares) at Dec. 31, 2017 | 22,000 | 17,674,729 | ||||||
Balance at Dec. 31, 2017 | $ 21,523 | $ 18 | 202,953 | (189,741) | (14) | 34,739 | ||
Issuance of common stock upon ESPP purchase | ||||||||
Stock-based compensation expense | 821 | 821 | ||||||
Net loss | (6,081) | (6,081) | ||||||
Other comprehensive gain/(loss) | 10 | 10 | ||||||
Balance (in shares) at Mar. 31, 2018 | 22,000 | 17,674,729 | ||||||
Balance at Mar. 31, 2018 | $ 21,523 | $ 18 | 203,774 | (195,822) | (4) | 29,489 | ||
Balance (in shares) at Dec. 31, 2017 | 22,000 | 17,674,729 | ||||||
Balance at Dec. 31, 2017 | $ 21,523 | $ 18 | 202,953 | (189,741) | (14) | 34,739 | ||
Unrealized gain on available-for-sale investments | 19 | |||||||
Net loss | (15,470) | |||||||
Balance (in shares) at Sep. 30, 2018 | 22,000 | 19,221,292 | ||||||
Balance at Sep. 30, 2018 | $ 21,523 | $ 19 | 208,536 | (205,211) | 4 | 24,871 | ||
Balance (in shares) at Dec. 31, 2017 | 22,000 | 17,674,729 | ||||||
Balance at Dec. 31, 2017 | $ 21,523 | $ 18 | 202,953 | (189,741) | (14) | 34,739 | ||
Issuance of common stock upon ESPP purchase (in shares) | 74,343 | |||||||
Issuance of common stock upon ESPP purchase | 132 | 132 | ||||||
Stock-based compensation expense | 3,429 | 3,429 | ||||||
Unrealized gain on available-for-sale investments | 20 | |||||||
Net loss | (20,729) | (20,729) | ||||||
Issuance of common stock, net of issuance costs (in shares) | 1,494,579 | |||||||
Issuance of common stock, net of issuance costs | $ 1 | 2,852 | 2,853 | |||||
Other comprehensive gain/(loss) | 19 | 19 | ||||||
Balance (in shares) at Dec. 31, 2018 | 22,000 | 19,243,651 | ||||||
Balance at Dec. 31, 2018 | $ 21,523 | $ 19 | 209,366 | (210,470) | 5 | 20,443 | ||
Balance (in shares) at Mar. 31, 2018 | 22,000 | 17,674,729 | ||||||
Balance at Mar. 31, 2018 | $ 21,523 | $ 18 | 203,774 | (195,822) | (4) | 29,489 | ||
Issuance of common stock upon ESPP purchase (in shares) | 51,984 | |||||||
Issuance of common stock upon ESPP purchase | 84 | 84 | ||||||
Stock-based compensation expense | 922 | 922 | ||||||
Net loss | (4,879) | (4,879) | ||||||
Other comprehensive gain/(loss) | 5 | 5 | ||||||
Balance (in shares) at Jun. 30, 2018 | 22,000 | 17,726,713 | ||||||
Balance at Jun. 30, 2018 | $ 21,523 | $ 18 | 204,780 | (200,701) | 1 | 25,621 | ||
Issuance of common stock upon ESPP purchase (in shares) | ||||||||
Issuance of common stock upon ESPP purchase | ||||||||
Stock-based compensation expense | 904 | 904 | ||||||
Unrealized gain on available-for-sale investments | 3 | |||||||
Net loss | (4,510) | (4,510) | ||||||
Issuance of common stock, net of issuance costs (in shares) | 1,494,579 | |||||||
Issuance of common stock, net of issuance costs | $ 1 | 2,852 | 2,853 | |||||
Other comprehensive gain/(loss) | 3 | 3 | ||||||
Balance (in shares) at Sep. 30, 2018 | 22,000 | 19,221,292 | ||||||
Balance at Sep. 30, 2018 | $ 21,523 | $ 19 | 208,536 | (205,211) | 4 | 24,871 | ||
Balance (in shares) at Dec. 31, 2018 | 22,000 | 19,243,651 | ||||||
Balance at Dec. 31, 2018 | $ 21,523 | $ 19 | 209,366 | (210,470) | 5 | 20,443 | ||
Stock-based compensation expense | 780 | 780 | ||||||
Net loss | (6,531) | (6,531) | ||||||
Other comprehensive gain/(loss) | (2) | (2) | ||||||
Balance (in shares) at Mar. 31, 2019 | 21,660 | 19,585,394 | ||||||
Balance at Mar. 31, 2019 | $ 21,183 | $ 19 | 210,486 | (217,001) | 3 | 14,690 | ||
Balance (in shares) at Dec. 31, 2018 | 22,000 | 19,243,651 | ||||||
Balance at Dec. 31, 2018 | $ 21,523 | $ 19 | 209,366 | (210,470) | 5 | $ 20,443 | ||
us-gaap_StockIssuedDuringPeriodSharesStockOptionsExercised | ||||||||
Unrealized gain on available-for-sale investments | ||||||||
Net loss | (13,382) | |||||||
Balance (in shares) at Sep. 30, 2019 | 21,660 | 19,585,394 | ||||||
Balance at Sep. 30, 2019 | $ 21,183 | $ 19 | 210,683 | (223,852) | 2 | 8,035 | ||
Balance (in shares) at Mar. 31, 2019 | 21,660 | 19,585,394 | ||||||
Balance at Mar. 31, 2019 | $ 21,183 | $ 19 | 210,486 | (217,001) | 3 | 14,690 | ||
Stock-based compensation expense | 101 | 101 | ||||||
Net loss | (5,315) | (5,315) | ||||||
Other comprehensive gain/(loss) | 1 | 1 | ||||||
Balance (in shares) at Jun. 30, 2019 | 21,660 | 19,585,394 | ||||||
Balance at Jun. 30, 2019 | $ 21,183 | $ 19 | 210,587 | (222,316) | 4 | 9,477 | ||
Stock-based compensation expense | 96 | 96 | ||||||
Unrealized gain on available-for-sale investments | ||||||||
Net loss | (1,536) | (1,536) | ||||||
Other comprehensive gain/(loss) | (2) | (2) | ||||||
Balance (in shares) at Sep. 30, 2019 | 21,660 | 19,585,394 | ||||||
Balance at Sep. 30, 2019 | $ 21,183 | $ 19 | $ 210,683 | $ (223,852) | $ 2 | $ 8,035 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating activities | |||
Net loss | $ (20,729,000) | $ (29,964,000) | $ (28,526,000) |
Reconciliation of net loss to net cash used in operating activities: | |||
Depreciation | 115,000 | 148,000 | 123,000 |
Amortization of premium/discount on available-for-sale securities | (51,000) | (2,000) | 131,000 |
Unrealized loss on forward foreign currency contracts included in net income | (127,000) | ||
Foreign currency remeasurement (loss)/gain | (25,000) | (173,000) | 76,000 |
Stock-based compensation | 3,429,000 | 3,227,000 | 3,343,000 |
Changes in: | |||
Prepaid expenses and other assets | 141,000 | 297,000 | 246,000 |
Interest receivable | 49,000 | (46,000) | (26,000) |
Accounts payable and accrued expenses | (6,162,000) | 4,161,000 | 1,073,000 |
Net cash used in operating activities | (23,233,000) | (22,352,000) | (23,687,000) |
Investing activities | |||
Purchases of available-for-sale investments | (15,443,000) | (32,942,000) | (39,756,000) |
Proceeds from maturities of available-for-sale investments | 31,990,000 | 16,878,000 | 59,943,000 |
Proceeds from sale of available-for-sale investments | 1,999,000 | ||
Purchase of property and equipment | (119,000) | (35,000) | (271,000) |
Net cash provided by investing activities | 18,427,000 | (16,099,000) | 19,916,000 |
Financing activities | |||
Proceeds from issuance of common stock, net of issuance costs | 2,853,000 | 1,288,000 | |
Proceeds from the issuance of Series A Convertible Preferred Stock, net of issuance costs | 21,523,000 | ||
Proceeds from issuance of common stock under ESPP | 132,000 | 130,000 | 11,000 |
Exercise of stock options | 108,000 | 197,000 | |
Net cash provided by financing activities | 2,985,000 | 23,049,000 | 208,000 |
Effect of exchange rate changes on cash | 22,000 | 180,000 | (76,000) |
Decrease in cash, cash equivalents and restricted cash | (1,799,000) | (15,222,000) | (3,639,000) |
Cash, cash equivalents and restricted cash, beginning of period | 21,192,000 | 36,414,000 | 40,045,000 |
Cash, cash equivalents and restricted cash, end of period | 19,393,000 | 21,192,000 | 36,414,000 |
Supplemental disclosure of non-cash investing and financing activities | |||
Accretion of convertible preferred stock | $ 6,747,000 |
Note 1 - Organization and Opera
Note 1 - Organization and Operations | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes to Financial Statements | ||
Nature of Operations [Text Block] | 1. Organization and Operations Proteon Therapeutics, Inc. (the "Company") is a biopharmaceutical company that has historically focused on the development of novel, first-in-class pharmaceuticals to address the medical needs of patients with kidney and vascular disease. The Company was formed in June 2001 and incorporated on March 24, 2006. On March 28, 2019, the Company announced that its second Phase 3 trial, PATENCY-2, for vonapanitase did not meet its co-primary endpoints of fistula use for hemodialysis (p=0.328) and secondary patency (p=0.932). The PATENCY-2 clinical trial was the second of two randomized, double-blind Phase 3 trials, comparing a 30 microgram dose of investigational vonapanitase to placebo in patients with chronic kidney disease, or CKD, undergoing creation of a radiocephalic fistula for hemodialysis. Following the release of top-line data from the PATENCY-2 clinical trial of vonapanitase on March 28, 2019, the Company began to evaluate its strategic alternatives focusing on enhancing stockholder value. It is conducting the process with the assistance of financial and legal advisors and is evaluating the full range of potential strategic alternatives, including but not limited to, a merger or sale of the Company, including a sale of assets or intellectual property, business combinations, joint ventures, public and private capital raises and recapitalization options. As part of these efforts, on April 15, 2019, the Company announced the engagement of H.C. Wainwright & Co., LLC as its financial advisor to assist in the strategic review process. Since these efforts may not be successful, the Company is also considering other possible alternatives, including a wind-down of operations and a liquidation and dissolution of the Company. On September 23, 2019, the Company entered into a merger agreement with ArTara Therapeutics, Inc. ("ArTara"). The Company has discontinued substantially all its research and development activities, including a reduction in workforce, to reduce operating expenses while it evaluates these opportunities. As of September 30, 2019, the Company has terminated all but one of its employees. The Company has recorded severance costs of $2.9 million, all of which was recorded in the three months ended June 30, 2019. These severance related expenses were fully recorded in the three months ending June 30, 2019. The Company remains subject to a number of risks similar to other companies in the biotechnology industry, including compliance with government regulations, protection of proprietary technology, dependence on third parties and product liability. As of September 30, 2019, the Company had cash and cash equivalents of $9.3 million. The Company believes that its existing cash and cash equivalents will be sufficient to fund its projected cash needs into 2020 and enable it to complete the proposed merger with ArTara, pursuant to which REM 1 Acquisition 1, Inc. (the "Merger Sub"), a wholly owned subsidiary of the Company, will be merged with and into ArTara, with ArTara surviving as a wholly owned subsidiary of the Company (the "Merger"). However, if there is a delay in completing the Merger, the Company will require additional capital to sustain its operations through such completion or the Company will need to pursue an immediate dissolution. If the Company needs additional capital, it would need to raise such capital through debt or equity financings, asset sales or other strategic transactions. However, there can be no assurances that the Company will be able to complete any such transaction on acceptable terms or otherwise. The failure to obtain sufficient funds on commercially acceptable terms when needed could have a material adverse effect on the Company's business, results of operations and financial condition and may prevent it from completing the Merger. Accordingly, these factors, among others, raise substantial doubt about the Company's ability to continue as a going concern. The Company had an accumulated deficit of $223.9 million as of September 30, 2019. The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to its administrative organization. Additionally, as stated above, the Company announced that its second Phase 3 trial, PATENCY-2, for vonapanitase did not meet its co-primary endpoints. As a result, the Company has discontinued substantially all its research and development activities to reduce operating expenses while it evaluates its strategic alternatives, including the Merger. These conditions raise substantial doubt about its ability to continue as a going concern within one year after the date that the financial statements are issued. To alleviate the conditions that raise substantial doubt about the Company's ability to continue as a going concern, management has implemented a reduction in expenditures plan and as referenced above is pursuing a merger. While the current reduction in spending expenditure plans will allow the Company to fund its operations in the near-term, there can be no assurance that the Company will be able to achieve its future strategic alternatives raising substantial doubt about its ability to continue as a going concern. Pursuant to the requirements of Accounting Standards Codification (ASC) 205-40, Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a going concern within one year after the date that the financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management's plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company's ability to continue as a going concern. The mitigating effect of management's plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity's ability to continue as a going concern within one year after the date that the financial statements are issued. Under ASC 2015-40, the strategic alternatives being pursued by the Company, including the Merger, cannot be considered probable at this time because none of the Company's current plans have been finalized at the time of filing this Quarterly Report on Form 10-Q and the implementation of any such plan is not probable of being effectively implemented as none of the plans are entirely within the Company's control. Accordingly, substantial doubt is deemed to exist about the Company's ability to continue as a going concern within one year after the date these financial statements are issued. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. On September 23, 2019, the Company entered into a merger agreement (the "Merger Agreement") with ArTara. Pursuant to the Merger Agreement, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, the Merger Sub, a wholly owned subsidiary of the Company, will merge with and into ArTara, with ArTara surviving as a wholly owned subsidiary of the Company. Subject to the terms and conditions of the Merger Agreement, at the effective time of the Merger (the "Effective Time"), each share of ArTara common stock outstanding immediately prior to the Effective Time (excluding certain shares to be canceled pursuant to the Merger Agreement and shares held by stockholders who have exercised and perfected appraisal rights will be converted into the right to receive a number of shares of the Company's common stock equal to the exchange ratio, as more fully described below. The Merger is intended to qualify for U.S. federal income tax purposes as a reorganization under the provisions of Section 368(a) of the Internal Revenue Code of 1986, as amended. As promptly as practicable after the date of the Merger Agreement (but in no event later than 50 days following the date of the Merger Agreement), the parties will prepare and the Company will file with the U.S. Securities and Exchange Commission ("SEC") a Registration Statement on Form S-4 (the "Registration Statement") to register the shares of the Company's common stock to be issued at the Effective Time under the Securities Act, and the Company will seek the approval of its stockholders with respect to certain actions, including the following (collectively, the "Company Stockholder Matters"): • the issuance of shares of the Company's common stock to ArTara's stockholders in connection with the transactions contemplated by the Merger Agreement and shares of the Company's capital stock to the institutional investors in the Private Placement, pursuant to The Nasdaq Stock Market LLC ("Nasdaq") rules; • the amendment of the Company's certificate of incorporation (i) to effect immediately prior to the closing of the Merger a reverse split of all outstanding shares of the Company's common stock at a reverse stock split ratio of one new share for every 30 to 50 (or any number in between) shares outstanding (the "Reverse Split") and (ii) to effect immediately after the consummation of the Private Placement the automatic conversion of all outstanding shares of Series A Convertible Preferred Stock (the "Series A Preferred Stock") of the Company into shares of the Company's common stock, without given effect to any existing provision that limits the conversion rights of the Series A Preferred Stock (including, without limitation, the 9.985% beneficial ownership cap) (the "Series A Preferred Automatic Conversion"); and • an amendment to the Company's Amended and Restated 2014 Equity Incentive Plan (the "Plan") to increase the shares available for issuance thereunder by such additional number of shares of the Company's common stock such that the total number of shares of the Company's common stock reserved for issuance under the Plan, after giving effect to such additional shares, would not exceed 15.2% of the shares of the Company's common stock outstanding immediately after the Effective Time, after giving effect to the Reverse Split, the Private Placement and the Series A Preferred Automatic Conversion, as determined by or on behalf of ArTara prior to the effectiveness of the Registration Statement (the "EIP Amendment"). The consummation of the Merger is also subject to the satisfaction or waiver of certain conditions, including, among other things, (i) approval by the Company's stockholders and ArTara's stockholders (other than with respect to the EIP Amendment), (ii) Nasdaq approval of the listing of the shares to be issued to ArTara equity holders in connection with the consummation of the Merger, (iii) satisfaction of all conditions precedent to the closing of the Private Placement (other than the consummation of the Merger and appointment of certain board members), (iv) absence of a material adverse effect since the date of the Merger Agreement, (v) the accuracy of the representations and warranties, subject to material adverse effect qualifications, (vi) compliance by the parties with their respective covenants in all material respects, (vii) the Subscription Agreement (as defined below) being in full force and effect and no less than $40.0 million to be committed thereunder and (viii) the Company having at least $0 in net cash as of the closing date of the Merger (the "Company Net Cash condition"). The Merger Agreement contains certain termination rights for both the Company and ArTara, and further provides that, upon termination of the Merger Agreement under specified circumstances, the Company may be required to pay to ArTara a termination fee of $0.8 million or ArTara may be required to pay to the Company a termination fee of $0.8 million, and in other circumstances each party may be required to reimburse the other party's expenses incurred, up to a maximum of $0.4 million. In accordance with the terms of the Merger Agreement, (i) certain executive officers, directors and stockholders of ArTara (solely in their respective capacities as ArTara stockholders) have entered into support agreements with ArTara and the Company to vote all of their shares of ArTara capital stock in favor of adoption of the Merger Agreement and (ii) certain of the Company's executive officers, directors and stockholders (solely in their respective capacities as the Company's stockholders) have entered into support agreements with ArTara and the Company to vote all of their shares of the its common stock in favor of the Company's Stockholder Matters. Concurrently with the execution of the Merger Agreement, the Company's director and ArTara's directors and officers have entered into lock-up agreements pursuant to which they accepted certain restrictions on transfer of shares of its common stock for the 180-day period following the closing of the Merger. At the Effective Time, the Company will effect a name change and it is anticipated that trading for the Company's securities will be listed on The Nasdaq Capital Market. Additionally, at the Effective Time, the Company's board of directors is expected to consist of seven members, with five such members designated by ArTara, one such member designated by the Company, and one such member who will be Jesse Shefferman, the President and Chief Executive Officer of the combined company. In connection with the Merger, on September 23, 2019, the company has entered into a Subscription Agreement (the "Subscription Agreement") with certain institutional investors (the "Investors"), pursuant to which the Company has agreed to issue in a private placement (the "Private Placement") (i) up to 27,200 shares of the Company's Series 1 Convertible Non-Voting Preferred Stock, par value $0.001 per share (the "Series 1 Preferred Stock"), at a purchase price equal to 1,000 times the Common Stock Purchase Price (as defined below) and (ii) up to 15,300 shares of the Company's common stock (together with the Series 1 Preferred Stock, the "Private Placement Shares"), at a purchase price equal to (x) the Aggregate Valuation (as defined in the Merger Agreement) divided by the (y) the Post-Closing Parent Shares (as defined in the Merger Agreement) (the "Common Stock Purchase Price"). Pursuant to the Subscription Agreement, certain holders of Series 1 Preferred Stock have preemptive rights to participate pro rata in the Company's future equity financings, subject to certain exceptions and limitations. In addition, following the issuance of the Private Placement Shares pursuant to the Subscription Agreement, the lead investor has the right (but not the obligation) to appoint up to two directors to the combined company's board and one other investor has the right (but not the obligation) to appoint one director to the combined company's board, in each case subject to requirements related to holding minimum amounts of the combined company's equity securities. In addition, at any time when it does not have a designee serving on the board, each of these investors has a right to designate an individual to be present and participate in a non-voting capacity in all meetings of the combined company's board and board committees. As of the date hereof, neither investor has notified the Company of an imminent intention to appoint such directors or non-voting observers. Further, the Company has also agreed not to take certain actions related to the business without the consent of the lead investor for so long as such lead investor continues to hold a minimum amount of the Private Placement Shares purchased under the Subscription Agreement. These actions include (a) liquidating, dissolving or winding-up the affairs of the company; (b) any merger, consolidation or other Fundamental Transaction (defined in the Subscription Agreement); (c) amendments to the combined company's certificate of incorporation or bylaws in a manner that adversely effects the Series 1 Preferred Stock and that is disproportionate to the effect on any other class or series of capital stock; (d) material changes to the principal business of the combined company; (e) purchases, redemptions or the payment of dividends on any capital stock (subject to certain exceptions); (f) the sale, assignment, license or pledge of TARA-002; and (g) transactions involving assets of the combined company with an aggregate value over a defined threshold. Prior to the issuance of the Private Placement Shares, the Company intends to file a Certificate of Designation of Preferences, Rights and Limitations of Series 1 Convertible Non-Voting Preferred Stock (the "Certificate of Designation") with the Delaware Secretary of State. Thereunder, each share of non-voting Series 1 Preferred Stock will be convertible into 1,000 shares of the Company's common stock, at a conversion price initially equal to the Common Stock Purchase Price, subject to adjustment for any stock splits, stock dividends and similar events, at any time at the option of the holder, provided that any conversion of Series 1 Preferred Stock by a holder into shares of the Company's common stock would be prohibited if, as a result of such conversion, the holder, together with its affiliates and any other person or entity whose beneficial ownership of the common stock would be aggregated with such holder's for purposes of Section 13(d) of the Exchange Act would beneficially own more than 9.99% of the total number of shares of the Company's common stock issued and outstanding after giving effect to such conversion. Upon written notice to the Company, the holder may from time to time increase or decrease such limitation to any other percentage not in excess of 19.99% specified in such notice. If the investors purchasing Series 1 Preferred Stock in the Private Placement each elect to increase such limitation to 19.99% and each investors elects to convert the maximum number of shares of Series 1 Preferred Stock into shares of voting common stock as would then be permitted, the investors in the Private Placement, together with the ArTara Private Placement, would own a majority of the outstanding shares of common stock, calculated as of immediately following the effectiveness of the Merger and Private Placements. As a result, these stockholders, acting together, could have substantial influence over most matters that require approval by the combined company's stockholders, including the election of directors, any merger, consolidation or sale of all or substantially all or of the combined company's assets or any other significant corporate transaction. However, Proteon has no reason to believe that these stockholders intend to convert their non-voting shares of Series 1 Preferred Stock to common stock or act together on any matters in the future. Each share of Series 1 Preferred Stock will be entitled to a preference of $10.00 per share upon the Company's liquidation, and thereafter will share ratably in any distributions or payments on an as-converted basis with the holders of the Company's common stock. In addition, upon the occurrence of certain transactions that involve the Company's merger or consolidation, an exchange or tender offer, a sale of all or substantially all of the Company's assets or a reclassification of the Company's common stock, each share of Series 1 Preferred Stock will be convertible into the kind and amount of securities, cash and/or other property that the holder of a number of shares of the Company's common stock issuable upon conversion of one share of Series 1 Preferred Stock would receive in connection with such transaction. The Private Placement is expected to close immediately following the consummation of the Merger. | 1. Organization and Operations The Company Proteon Therapeutics, Inc. (the “Company”) is a late-stage biopharmaceutical company focused on the development of novel, first June 2001 March 24, 2006. The Company devotes substantially all of its efforts to product research and development, initial market development and raising capital. The Company has not third Liquidity and Going Concern As of December 31, 2018, $21.9 first 2020. $210.5 December 31, 2018. Based on these available cash resources, the Company does not twelve 10 The Company’s plans to address this condition include pursuing one none • raise additional funding through the possible sale of additional shares of the Company’s common stock, including public or private equity financings, and/or possible debt financings; and • use the worldwide commercial rights to vonapanitase currently held by the Company to establish partnerships for the development and commercialization of vonapanitase in all or parts of Europe and other countries outside of the United States to secure additional funding. There can be no twelve 10 Pursuant to the requirements of Accounting Standards Codification (ASC) 205 40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern one not not 1 one 2 one Under ASC 2015 40, none 10 not none one The Company believes that its approximate $21.9 December 31, 2018, first 2020. no no no 2019 If the Company is unable to obtain sufficient capital to continue to advance its programs, the Company would be forced to delay, reduce or eliminate its ongoing development and other activities. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not At-The-Market Equity Offering Program On November 12, 2015, 3 $40 January 12, 2016. 3% March 16, 2017 I.B.6 3, may February 7, 2019, 3, No. 333 228865, December 31, 2017, 896,811 $1.4 $0.1 December 31, 2018, 1,494,579 $3.0 December 31, 2018, $46,000, 1,494,579 December 31, 2018 September 25, 2018 Series A Preferred Financing On June 22, 2017, 22,000 $0.001 $1,000 $22.0 August 2, 2017 ( 7 On August 2, 2017, August 3, 2017, 3 August 21, 2017. |
Note 2 - Summary of Significant
Note 2 - Summary of Significant Accounting Policies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes to Financial Statements | ||
Significant Accounting Policies [Text Block] | 2. Summary of Significant Accounting Policies Basis of Presentation, Principles of Consolidation and Use of Estimates The unaudited interim condensed consolidated financial statements of the Company included herein have been prepared, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the financial statements as of and for the year ended December 31, 2018 10 March 13, 2019. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements. In the opinion of the Company’s management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments which are necessary to fairly present the Company’s financial position as of September 30, 2019, three nine September 30, 2019 2018, nine September 30, 2019 2018, nine September 30, 2019 2018. three nine September 30, 2019 not December 31, 2019, The unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. These condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not may Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, available-for-sale investments, accounts payable, and accrued liabilities. The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. FASB ASC Topic 820, Fair Value Measurement and Disclosures not one three Level 1—Valuations Level 2—Valuations not Level 3—Valuations To the extent that 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 in Level 3. Financial instruments measured at fair value on a recurring basis include cash equivalents and available-for-sale investments. There have been no three nine September 30, 2019 2018. no three nine September 30, 2019 2018. Net Income (Loss) per Share Attributable to Common Stockholders Basic net income (loss) per share is calculated by dividing net income (loss) attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net income per share is calculated by dividing the net income attributable to common stockholders by the weighted-average number of common equivalent shares outstanding for the period, including any dilutive effect from outstanding stock options and warrants using the treasury stock method. The Company follows the two two two not Recent Accounting Pronouncements In May 2014, 2014 09, 2014 09” January 1, 2018, 2017 09 March 31, 2018. not In February 2016, 2016 02, 842 2016 02” 2016 01 January 1, 2019 not 842, 842. 842 842, not As a result of the adoption of ASU 2016 02, January 1, 2019, $0.2 8%, $0.2 no January 1, 2019. not 2016 02. In August 2016, 2016 15, 230 2016 15” eight December 15, 2017, first 2018 2016 15 March 31, 2018. not In November 2016, 2016 18, December 15, 2017, first 2018. 2016 18 March 31, 2018. $22,000 $22,000 nine September 30, 2019 2018. In May 2017, No. 2017 09, 718 2017 09” 2017 09, not 2017 09 December 15, 2017. 2017 09 March 31, 2018. not In June 2018, No. 2018 07, 718 2018 07” 2018 07 2018 07 December 15, 2018. January 1, 2019. 2018 07 March 31, 2019. not March 31, 2018. | 2. Summary of Significant Accounting Policies Basis of Presentation, Principles of Consolidation and Use of Estimates The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. These consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not may Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company and the Company's chief operating decision maker view the Company's operations and manage its business in one one Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, available-for-sale investments, forward foreign currency contracts (see Note 3 820, Fair Value Measurement and Disclosures not one three Level 1—Valuations Level 2—Valuations not Level 3—Valuations To the extent that 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 in Level 3. Financial instruments measured at fair value on a recurring basis include cash equivalents, available-for-sale investments and forward foreign currency contracts (see Note 3 no December 31, 2018 2017. no December 31, 2018 2017. Recent Accounting Pronouncements In May 2014, 2014 09, Revenue from Contracts with Customers 2014 09” January 1, 2018, 2017 09 March 31, 2018. not In February 2016, 2016 02, 842 2016 02” January 1, 2019 not In August 2016, 2016 15, Statement of Cash Flows (Topic 230 2016 15” eight December 15, 2017, first 2018 2016 15 March 31, 2018. not In November 2016, 2016 18, Statement of Cash Flows, Restricted Cash December 15, 2017, first 2018. 2016 18 March 31, 2018. $22,000 $14,000 December 31, 2018 2017, $22,000 December 31, 2018 2017. In May 2017, No. 2017 09, Compensation - Stock Compensation (Topic 718 2017 09” 2017 09, not 2017 09 December 15, 2017. 2017 09 March 31, 2018. not In June 2018, No. 2018 07, 718 2018 07” 2018 07 2018 07 December 15, 2018. January 1, 2019. Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of 90 Short-Term Investments The Company classifies its investments as available-for-sale and records such assets at estimated fair value in the consolidated balance sheets, with unrealized gains and losses, if any, reported as a component of other comprehensive income (loss) within the consolidated statements of operations and comprehensive loss and as a separate component of stockholders' equity (deficit). The Company invests its excess cash balances primarily in government debt securities and money market funds with strong credit ratings and maturities of less than one no December 31, 2018, 2017 2016. At each balance sheet date, the Company assesses available-for-sale securities in an unrealized loss position to determine whether the unrealized loss is other-than-temporary. The Company considers factors including: the significance of the decline in value compared to the cost basis, underlying factors contributing to a decline in the prices of securities in a single asset class, the length of time the market value of the security has been less than its cost basis, the security's relative performance versus its peers, sector or asset class, expected market volatility and the market and economy in general. When the Company determines that a decline in the fair value below its cost basis is other-than-temporary, the Company recognizes an impairment loss in the year in which the other-than-temporary decline occurred. There have been no December 31, 2018, 2017 2016, not Concentrations of Credit Risk and Off-Balance Sheet Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents and short-term investments. The Company's cash and cash equivalents are held in accounts with financial institutions that management believes are creditworthy. The Company's investment policy includes guidelines on the quality of the institutions and financial instruments and defines allowable investments that the Company believes minimizes the exposure to concentration of credit risk. These amounts at times may not not no Property and Equipment Property and equipment is stated at cost, less accumulated depreciation. Maintenance and repairs that do not not, Asset Estimated Useful Life (in years) Computer equipment and software 3 Furniture, fixtures and other 5 Laboratory equipment 7 Research and Development Costs Research and development costs are charged to expense as incurred in performing research and development activities. The costs include employee compensation costs, facilities and overhead, clinical study and related clinical manufacturing costs, regulatory and other related costs. Nonrefundable advanced payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. Stock-Based Compensation Expense The Company accounts for its stock-based compensation awards to employees and directors in accordance with FASB ASC Topic 718, Compensation-Stock Compensation 718” 718 718 505, Equity The Company estimates the fair value of its stock options using the Black-Scholes option pricing model, which requires the input of subjective assumptions, including (a) the expected stock price volatility, (b) the expected term of the award, (c) the risk-free interest rate, (d) expected dividends and (e) the estimated fair value of its Common Stock on the measurement date. Due to the lack of company specific historical and implied volatility data of its Common Stock, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. When selecting these public companies on which it has based its expected stock price volatility, the Company selected companies with comparable characteristics to it, including enterprise value, risk profiles, position within the industry and with historical share price information sufficient to meet the expected term of the stock based awards. The Company computes historical volatility data using the daily closing prices for the selected companies' shares during the equivalent period of the calculated expected term of the stock-based awards. During 2018 not 2, Use of Estimates Income Taxes Income taxes are recorded in accordance with FASB ASC Topic 740, 740” not not may not The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. not not December 31, 2018 2017, not 10 Net Income (Loss) per Share Attributable to Common Stockholders Basic net income (loss) per share is calculated by dividing net income (loss) attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net income per share is calculated by dividing the net income attributable to common stockholders by the weighted-average number of common equivalent shares outstanding for the period, including any dilutive effect from outstanding stock options and warrants using the treasury stock method. The Company follows the two two two not Comprehensive Loss Comprehensive loss consists of net income or loss and changes in equity during a period from transactions and other events and circumstances generated from non-owner sources. The Company's net loss equals comprehensive loss, net of any changes in the unrealized gains and losses of the Company's short-term investments, held as available-for-sale, and foreign currency translation for all periods presented. Subsequent Events The Company considers events or transactions that occur after the balance sheet date but prior to the date the consolidated financial statements are available to be issued for potential recognition or disclosure in the financial statements. The Company has completed an evaluation of all subsequent events after the consolidated balance sheet date of December 31, 2018 December 31, 2018 not |
Note 3 - Fair Value Measurement
Note 3 - Fair Value Measurements | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes to Financial Statements | ||
Fair Value Disclosures [Text Block] | 3. Fair Value Measurements Below is a summary of assets and liabilities measured at fair value (in thousands): As of September 30, 2019 Quoted Prices Significant Significant Total Assets Cash equivalents $ 9,101 $ - $ - $ 9,101 Total $ 9,101 $ - $ - $ 9,101 As of December 31, 2018 Quoted Prices Significant Significant Total Assets Cash equivalents $ 18,353 $ - $ - $ 18,353 Government securities 2,496 - - 2,496 Total $ 20,849 $ - $ - $ 20,849 As of September 30, 2019 December 31, 2018, 90 Available-for-sale securities at September 30, 2019 December 31, 2018 Amortized Cost Unrealized Gains Unrealized Losses Fair Value September 30, 2019 Government securities (Due within 1 year) $ - $ - $ - $ - $ - $ - $ - $ - December 31, 2018 Government securities (Due within 1 year) $ 2,496 $ - $ - $ 2,496 $ 2,496 $ - $ - $ 2,496 | 3. Fair Value Measurements Below is a summary of assets and liabilities measured at fair value (in thousands): As of December 31, 2018 Quoted Prices Significant Significant in Active Observable Unobservable Markets Inputs Inputs (Level 1) (Level 2) (Level 3) Total Assets Cash equivalents $ 18,353 $ - $ - $ 18,353 Government securities 2,496 - - 2,496 Total $ 20,849 $ - $ - $ 20,849 As of December 31, 2017 Quoted Prices Significant Significant in Active Observable Unobservable Markets Inputs Inputs (Level 1) (Level 2) (Level 3) Total Assets Cash equivalents $ 11,662 $ - $ - $ 11,662 Government securities 20,971 - - 20,971 Total $ 32,633 $ - $ - $ 32,633 As of December 31, 2018, 2017, 90 Available-for-sale securities at December 31, 2018 2017 Amortized Cost Unrealized Gains Unrealized Losses Fair Value December 31, 2018 Government securities (Due within 1 year) $ 2,496 $ - $ - $ 2,496 $ 2,496 $ - $ - $ 2,496 December 31, 2017 Government securities (Due within 1 year) $ 20,991 $ - $ (20 ) $ 20,971 $ 20,991 $ - $ (20 ) $ 20,971 |
Note 4 - Property and Equipment
Note 4 - Property and Equipment, Net | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes to Financial Statements | ||
Property, Plant and Equipment Disclosure [Text Block] | 4. Property and Equipment, net Property and equipment, net consists of the following (in thousands): As of September 30, 2019 December 31, 2018 Computer equipment and software $ - $ 211 Furniture, fixtures, and other - 365 Laboratory equipment - 514 - 1,090 Accumulated depreciation - (827 ) Property and equipment, net $ - $ 263 Depreciation expense for the three nine September 30, 2019 $0.1 $0.3 three nine September 30, 2018 $22,000, $0.1 During the three March 31, 2019, March 31, 2019 March 31, 2019. September 30, 2019, no zero $0.2 three nine September 30, 2019. September 30, 2019, no | 4. Property and Equipment, net Property and equipment, net consists of the following (in thousands): As of December 31, 2018 2017 Computer equipment and software $ 211 $ 192 Furniture, fixtures, and other 365 302 Laboratory equipment 514 477 1,090 971 Accumulated depreciation (827 ) (712 ) Property and equipment, net $ 263 $ 259 Depreciation expense for the years ended December 31, 2018, 2017 2016 $0.1 $0.1 $0.1 |
Note 5 - Accrued Expenses
Note 5 - Accrued Expenses | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Accounts Payable and Accrued Liabilities Disclosure [Text Block] | 5. Accrued Expenses Accrued expenses consist of the following (in thousands): As of December 31, 2018 2017 Payroll and employee-related costs $ 1,390 $ 1,318 Contracted service costs 968 7,218 Professional fees and other 279 413 Total $ 2,637 $ 8,949 |
Note 6 - Commitments and Contin
Note 6 - Commitments and Contingencies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes to Financial Statements | ||
Commitments and Contingencies Disclosure [Text Block] | 5. Commitments and Contingencies Operating Lease The Company’s facility is located in Waltham, Massachusetts. In July 2018, September 2019. three nine September 30, 2019, $0.1 $0.2 September 30, 2019, not September 30, 2019, no September 30, 2019, $22,000 30 September 30, 2019. Restricted cash related to facilities leases As of September 30, 2019 December 31, 2018, $22,000 September 30, 2019 December 31, 2018, $22,000 30 September 30, 2019. | 6. Commitments and Contingencies Significant Contracts and Agreements In February 2002, 2.5% December 31, 2018 not no Operating Leases The Company has various non-cancellable operating leases for facilities and office equipment that expire at various dates through 2019. August 2017, July 13, 2009 ( fifteen 15 June 30, 2018 September 30, 2019 2,552 7,500 200 one six $0.3 $0.2 $0.2 December 31, 2018, 2017 2016, Future minimum payments required under operating leases as of December 31, 2018 Year Ending December 31: Amount 2019 207 Total minimum lease payments $ 207 In addition to the base rent, the Company is also responsible for its share of operating expenses and real estate taxes, in accordance with the terms of the lease agreement. As of December 31, 2018, $22,000 Restricted cash related to facilities leases At December 31, 2018 2017, $22,000 December 31, 2018 2017, $22,000 |
Note 7 - Series A Preferred Fin
Note 7 - Series A Preferred Financing | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Preferred Stock [Text Block] | 7. Series A Preferred Financing On August 2, 2017, 22,000 $0.001 $1,000 $22.0 June 22, 2017. $0.5 1,005 $0.9949 13 9.985% December 31, 2018 2017, 22,000 Upon issuance, each share of Series A Preferred included an embedded beneficial conversion feature as the market price of the Company’s Common Stock on the date of issuance of the Series A Preferred was $1.30 $6.7 not The Company evaluated the Series A Preferred for liability or equity classification in accordance with the provisions of ASC 480, not not not not 480 no not Dividends Holders of the Series A Preferred Stock are entitled to receive dividends, if and when declared by the Board of Directors. Liquidation Preference Holders of the Series A Preferred Stock have preference in the event of a liquidation or dissolution of the Company equal to $0.001 Thereafter, the Holders of the shares of Series A Preferred Stock shall share ratably in any distributions and payments of any remaining assets of the Company, on an as converted basis, with the holders of Common Stock. Voting Rights Except for matters with specific voting rights as provided in the Series A Preferred Stock Purchase Agreement, the Holders of shares of Series A Preferred Stock have no |
Note 8 - Common Stock
Note 8 - Common Stock | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Common Stock [Text Block] | 8. Common Stock General At December 31, 2018, 100,000,000 $0.001 19,243,651 Reserved for Future Issuance The Company has the following shares of Common Stock reserved for future issuance: December 31, December 31, 2018 2017 Conversion of Series A Preferred Stock 22,112,775 22,112,775 Stock-based compensation awards 5,163,957 3,572,457 Employee Stock Purchase Plan 118,120 192,463 Total 27,394,852 25,877,695 |
Note 9 - Stock-based Compensati
Note 9 - Stock-based Compensation | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes to Financial Statements | ||
Share-based Payment Arrangement [Text Block] | 6. Stock-based Compensation Stock Options The following table summarizes stock option activity for employees: Options Weighted- Weighted- Aggregate Outstanding at December 31, 2018 4,597,226 $ 5.12 7.4 $ 404 Granted 1,182,500 $ 2.66 Exercised - Forfeited (1) (2,606,289 ) $ 2.79 Expired (1) (2,400,590 ) $ 6.51 Outstanding at September 30, 2019 772,847 $ 4.89 7.3 $ - Exercisable at September 30, 2019 476,390 $ 6.13 6.4 $ - Vested or expected to vest at September 30, 2019 (2) 772,847 $ 4.89 7.3 $ - _____________________ ( 1 nine September 30, 2019 ( 2 September 30, 2019 September 30, 2019. Employee Stock Purchase Plan The 2014 140,500 January 1, January 1, 2015 January 1, 2024, one 281,000 January 1st. September 30, 2019, January 1, 2019 one December 31, 2018, 2014 192,436 tenth 2014 July 1, 2019 September 30, 2019. No three nine September 30, 2019. No 51,984 three nine September 30, 2018 2014 zero $68,000 2014 three nine September 30, 2019 $20,000 $0.1 2014 three nine September 30, 2018, Common Stock The Company has the following shares of Common Stock reserved for future issuance: September 30, December 31, 2019 2018 Conversion of Series A Preferred Stock 21,771,032 22,112,775 Stock-based compensation awards 6,818,214 5,163,957 Employee Stock Purchase Plan 118,120 118,120 Total 28,707,366 27,394,852 | 9. Stock-based Compensation On August 21, 2014, 2006 “2006 2014 “2014 2014 “2014 October 3, 2014, 2014 July 31, 2017. The Plans provide for the grant of incentive and non-statutory stock options, stock appreciation rights, restricted stock and stock unit awards, performance units, stock grants and qualified performance-based awards. Under the 2006 no 704,000 2014 2014 2014 January 1, January 1, 2015 four December 31 January 1st. Terms of the stock awards, including vesting requirements, are determined by the Board of Directors, subject to the provisions of the Plans. Options granted by the Company typically vest over three four 2006 ten 2014 Stock-based compensation expense Total stock-based compensation expense is recognized for stock options granted to employees and non-employees and has been reported in the Company’s consolidated statements of operations as follows (in thousands): Year Ended December 31, 2018 2017 2016 Research and development $ 1,142 $ 1,109 $ 1,114 General and administrative 2,287 2,118 2,229 Total $ 3,429 $ 3,227 $ 3,343 The Company estimates the fair value of each employee stock award on the grant date using the Black-Scholes option-pricing model based on the following assumptions regarding the fair value of the underlying Common Stock on each measurement date: Year Ended December 31, 2018 2017 2016 Weighted average expected volatility 93.5 % 94.5 % 84.4 % Expected term (in years) 6.07 6.06 6.05 Risk free interest rate 2.55 % 2.09 % 1.45 % Expected dividend yield 0 % 0 % 0 % Stock options issued to non-employees are accounted for using the fair value method of accounting; they are periodically revalued as the options vest and are recognized as expense over the related service period. The total expense related to all options granted to non-employees was $0 December 31, 2018, 2017 2016. Stock Options The following table summarizes stock option activity for employees and non-employees: Options Weighted- Weighted- Aggregate Outstanding at December 31, 2017 2,681,072 $ 7.18 6.8 $ 121 Granted 2,041,600 $ 2.61 Exercised - Forfeited (83,433 ) $ 5.82 Expired (42,013 ) $ 13.30 Outstanding at December 31, 2018 4,597,226 $ 5.12 7.4 $ 404 Exercisable at December 31, 2018 2,067,356 $ 7.57 5.7 $ 241 Vested or expected to vest at December 31, 2018 (1) 4,597,226 $ 5.12 7.4 $ 404 __________________ ( 1 December 31, 2018 December 31, 2018. During the year ended December 31, 2018, 2,041,600 $2.61. December 31, 2017, 719,337 $1.99. December 31, 2016, 132,495 $7.11 $5.08. The total intrinsic value of options exercised in the years ended December 31, 2018 2017 $0 $27,000 December 31, 2018, 2017 $4.6 $4.2 2.40 Employee Stock Purchase Plan The 2014 140,500 January 1, January 1, 2015 January 1, 2024, one 281,000 January 1st. no January 1, 2018. December 31, 2018, 2014 304,991 seventh 2014 January 1, 2018 June 30, 2018 eight July 1, 2018 December 31, 2018. December 31, 2018 2017, 74,343 100,358 2014 $0.1 2014 December 31, 2018, 2017, 2016. |
Note 10 - Income Taxes
Note 10 - Income Taxes | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes to Financial Statements | ||
Income Tax Disclosure [Text Block] | 7. Income Taxes Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes. The Company has evaluated the positive and negative evidence bearing upon the Company’s ability to realize the benefit of its deferred tax assets. Based on the Company’s history of operating losses, the Company has concluded that it is more likely than not not no nine September 30, 2019 2018. | 10. Income Taxes The components of loss from operations before income taxes are as follows (in thousands): Year Ended December 31, 2018 2017 2016 Domestic $ (17,855 ) $ (24,803 ) $ (15,860 ) Foreign (2,874 ) (5,161 ) (12,666 ) Total $ (20,729 ) $ (29,964 ) $ (28,526 ) For the years ended December 31, 2018, 2017, 2016, not A reconciliation of income taxes computed using the U.S. federal statutory rate to that reflected in operations is as follows (in thousands): Year Ended December 31, 2018 2017 2016 Income tax benefit computed at federal statutory tax rate $ (4,348 ) $ (10,186 ) $ (9,696 ) Permanent differences 6 4 430 Stock compensation - permanent items 325 689 - R&D credit - permanent items - 1,751 1,437 State income taxes, net of federal benefit (958 ) (853 ) (498 ) Tax credits (1,466 ) (5,495 ) (4,846 ) Change in valuation allowance 5,409 (54,319 ) 8,804 Foreign rate differential 602 1,752 4,304 Rate change - 2,202 - 382 limitation - 64,975 - Other 430 (520 ) 65 Total $ - $ - $ - The significant components of the Company's deferred tax assets are as follows (in thousands): Year Ended December 31, 2018 2017 2016 Deferred tax assets: Net operating loss carryforwards $ 6,742 $ 2,651 $ 37,237 Federal and state tax credits 3,122 2,244 21,223 Accrued expenses 411 399 544 Patents 132 191 360 Stock-based compensation 1,782 1,262 1,353 Other 169 202 321 Total deferred tax assets 12,358 6,949 61,038 Valuation allowance (12,358 ) (6,949 ) (61,038 ) Net deferred assets $ - $ - $ - Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. Based on the Company's history of operating losses, management of the Company has concluded that it is more likely than not not December 31, 2018, 2017, 2016. On December 22, 2017, 34% 21%. $2.2 no not 2017 2018 The Company’s preliminary estimate of the TCJA and the remeasurement of its deferred tax assets and liabilities is subject to the finalization of management’s analysis related to certain matters, such as developing interpretations of the provisions of the TCJA, changes to certain estimates and the filing of our tax returns. U.S. Treasury regulations, administrative interpretations or court decisions interpreting the TJCA may 2017 fourth 2018 no Net operating loss and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service (the "IRS") and may three 50% 382 383 may August 2, 2017, $22.0 §382 §383 August 2, 2017 August 2, 2017 $107.3 $34.1 $23.8 $5.0 $2.1 As a result of current year activity, the valuation allowance increased by approximately $5.4 December 31, 2018. December 31, 2017, $13.1 $65.0 §382 $2.2 $54.1 $8.8 December 31, 2016, Subject to the limitations described below, as of December 31, 2018, 2017, 2016, $25.7 $10.6 $0.0 2018 2037. 2018 December 31, 2018 $14.7 December 31, 2018, 2017, 2016, $21.5 $6.8 $0.0 2037 2038. December 31, 2018, 2017 2016, $3.1 $2.3 $0.0 2037 2038. The Company had no December 31, 2018, 2017, 2016. The Company is subject to U.S. federal income tax and primarily Massachusetts state income tax. The statute of limitations for assessment by the IRS and state tax authorities is open for tax years ending December 31, 2015 2018, 2015 may no |
Note 11 - Net Loss Per Share At
Note 11 - Net Loss Per Share Attributable to Common Stockholders | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes to Financial Statements | ||
Earnings Per Share [Text Block] | 8. Net Loss per Share Attributable to Common Stockholders As described in Note 2, three nine September 30, 2019 2018 no two The following Common Stock equivalents, presented on an as converted basis, were excluded from the calculation of net loss per share for the periods presented, due to their anti-dilutive effect: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Outstanding stock options 772,847 4,597,226 772,847 4,597,226 Outstanding ESPP shares - 26,642 - 26,642 Convertible preferred stock 21,771,032 22,112,775 21,771,032 22,112,775 22,543,879 26,736,643 22,543,879 26,736,643 | 11. Net Loss per Share Attributable to Common Stockholders As described in Note 2, December 31, 2018, 2017 2016 no two 2017 not $6.7 not The following Common Stock equivalents, presented on an as converted basis, were excluded from the calculation of net loss per share for the periods presented, due to their anti-dilutive effect: Year Ended December 31, 2018 2017 2016 Outstanding stock options 4,597,226 2,681,072 2,166,254 Convertible preferred stock 22,112,775 22,112,775 - 26,710,001 24,793,847 2,166,254 |
Note 12 - Quarterly Financial I
Note 12 - Quarterly Financial Information (Unaudited, in Thousands, Except Share and Per Share Data) | 12 Months Ended |
Dec. 31, 2018 | |
Notes to Financial Statements | |
Quarterly Financial Information [Text Block] | 12. Quarterly Financial Information (unaudited, in thousands, except share and per share data) The following table contains selected quarterly financial information from 2018 2017. not Three Months Ended (a) March 31, June 30, September 30, December 31, 2018 2018 2018 2018 Operating expenses $ 6,365 $ 5,000 $ 4,622 $ 5,385 Net loss attributable to common stockholders (6,081 ) (4,879 ) (4,510 ) (5,259 ) Net loss per share attributable to common stockholders: Basic and Diluted $ (0.34 ) $ (0.28 ) $ (0.25 ) $ (0.27 ) Weighted-average common shares outstanding used in net loss per share attributable to common stockholders: Basic and Diluted 17,674,729 17,674,729 17,824,186 19,221,292 Three Months Ended (a) March 31, June 30, September 30, December 31, 2017 2017 2017 2017 Operating expenses $ 6,480 $ 5,986 $ 12,306 $ 5,590 Net loss attributable to common stockholders (6,498 ) (5,608 ) (19,054 ) (5,551 ) Net loss per share attributable to common stockholders: Basic and Diluted $ (0.39 ) $ (0.33 ) $ (1.08 ) $ (0.33 ) Weighted-average common shares outstanding used in net loss per share attributable to common stockholders: Basic and Diluted 16,636,201 17,207,672 17,619,418 (b) 17,619,418 __________________ (a) The amounts were computed independently for each quarter, and the sum of the quarters may not (b) Adjusted to correct an immaterial error in the weighted-average share calculation in the Company's Form 10 September 30, 2017. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | ||
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation, Principles of Consolidation and Use of Estimates The unaudited interim condensed consolidated financial statements of the Company included herein have been prepared, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the financial statements as of and for the year ended December 31, 2018 10 March 13, 2019. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements. In the opinion of the Company’s management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments which are necessary to fairly present the Company’s financial position as of September 30, 2019, three nine September 30, 2019 2018, nine September 30, 2019 2018, nine September 30, 2019 2018. three nine September 30, 2019 not December 31, 2019, The unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. These condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not may | Basis of Presentation, Principles of Consolidation and Use of Estimates The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. These consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not may |
Fair Value Measurement, Policy [Policy Text Block] | Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, available-for-sale investments, accounts payable, and accrued liabilities. The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. FASB ASC Topic 820, Fair Value Measurement and Disclosures not one three Level 1—Valuations Level 2—Valuations not Level 3—Valuations To the extent that 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 in Level 3. Financial instruments measured at fair value on a recurring basis include cash equivalents and available-for-sale investments. There have been no three nine September 30, 2019 2018. no three nine September 30, 2019 2018. | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company and the Company's chief operating decision maker view the Company's operations and manage its business in one one |
Derivatives, Policy [Policy Text Block] | Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, available-for-sale investments, forward foreign currency contracts (see Note 3 820, Fair Value Measurement and Disclosures not one three Level 1—Valuations Level 2—Valuations not Level 3—Valuations To the extent that 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 in Level 3. Financial instruments measured at fair value on a recurring basis include cash equivalents, available-for-sale investments and forward foreign currency contracts (see Note 3 no December 31, 2018 2017. no December 31, 2018 2017. | |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements In May 2014, 2014 09, 2014 09” January 1, 2018, 2017 09 March 31, 2018. not In February 2016, 2016 02, 842 2016 02” 2016 01 January 1, 2019 not 842, 842. 842 842, not As a result of the adoption of ASU 2016 02, January 1, 2019, $0.2 8%, $0.2 no January 1, 2019. not 2016 02. In August 2016, 2016 15, 230 2016 15” eight December 15, 2017, first 2018 2016 15 March 31, 2018. not In November 2016, 2016 18, December 15, 2017, first 2018. 2016 18 March 31, 2018. $22,000 $22,000 nine September 30, 2019 2018. In May 2017, No. 2017 09, 718 2017 09” 2017 09, not 2017 09 December 15, 2017. 2017 09 March 31, 2018. not In June 2018, No. 2018 07, 718 2018 07” 2018 07 2018 07 December 15, 2018. January 1, 2019. 2018 07 March 31, 2019. not March 31, 2018. | Recent Accounting Pronouncements In May 2014, 2014 09, Revenue from Contracts with Customers 2014 09” January 1, 2018, 2017 09 March 31, 2018. not In February 2016, 2016 02, 842 2016 02” January 1, 2019 not In August 2016, 2016 15, Statement of Cash Flows (Topic 230 2016 15” eight December 15, 2017, first 2018 2016 15 March 31, 2018. not In November 2016, 2016 18, Statement of Cash Flows, Restricted Cash December 15, 2017, first 2018. 2016 18 March 31, 2018. $22,000 $14,000 December 31, 2018 2017, $22,000 December 31, 2018 2017. In May 2017, No. 2017 09, Compensation - Stock Compensation (Topic 718 2017 09” 2017 09, not 2017 09 December 15, 2017. 2017 09 March 31, 2018. not In June 2018, No. 2018 07, 718 2018 07” 2018 07 2018 07 December 15, 2018. January 1, 2019. |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of 90 | |
Investment, Policy [Policy Text Block] | Short-Term Investments The Company classifies its investments as available-for-sale and records such assets at estimated fair value in the consolidated balance sheets, with unrealized gains and losses, if any, reported as a component of other comprehensive income (loss) within the consolidated statements of operations and comprehensive loss and as a separate component of stockholders' equity (deficit). The Company invests its excess cash balances primarily in government debt securities and money market funds with strong credit ratings and maturities of less than one no December 31, 2018, 2017 2016. At each balance sheet date, the Company assesses available-for-sale securities in an unrealized loss position to determine whether the unrealized loss is other-than-temporary. The Company considers factors including: the significance of the decline in value compared to the cost basis, underlying factors contributing to a decline in the prices of securities in a single asset class, the length of time the market value of the security has been less than its cost basis, the security's relative performance versus its peers, sector or asset class, expected market volatility and the market and economy in general. When the Company determines that a decline in the fair value below its cost basis is other-than-temporary, the Company recognizes an impairment loss in the year in which the other-than-temporary decline occurred. There have been no December 31, 2018, 2017 2016, not | |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentrations of Credit Risk and Off-Balance Sheet Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents and short-term investments. The Company's cash and cash equivalents are held in accounts with financial institutions that management believes are creditworthy. The Company's investment policy includes guidelines on the quality of the institutions and financial instruments and defines allowable investments that the Company believes minimizes the exposure to concentration of credit risk. These amounts at times may not not no | |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment Property and equipment is stated at cost, less accumulated depreciation. Maintenance and repairs that do not not, Asset Estimated Useful Life (in years) Computer equipment and software 3 Furniture, fixtures and other 5 Laboratory equipment 7 | |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Costs Research and development costs are charged to expense as incurred in performing research and development activities. The costs include employee compensation costs, facilities and overhead, clinical study and related clinical manufacturing costs, regulatory and other related costs. Nonrefundable advanced payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. | |
Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block] | Stock-Based Compensation Expense The Company accounts for its stock-based compensation awards to employees and directors in accordance with FASB ASC Topic 718, Compensation-Stock Compensation 718” 718 718 505, Equity The Company estimates the fair value of its stock options using the Black-Scholes option pricing model, which requires the input of subjective assumptions, including (a) the expected stock price volatility, (b) the expected term of the award, (c) the risk-free interest rate, (d) expected dividends and (e) the estimated fair value of its Common Stock on the measurement date. Due to the lack of company specific historical and implied volatility data of its Common Stock, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. When selecting these public companies on which it has based its expected stock price volatility, the Company selected companies with comparable characteristics to it, including enterprise value, risk profiles, position within the industry and with historical share price information sufficient to meet the expected term of the stock based awards. The Company computes historical volatility data using the daily closing prices for the selected companies' shares during the equivalent period of the calculated expected term of the stock-based awards. During 2018 not 2, Use of Estimates | |
Income Tax, Policy [Policy Text Block] | Income Taxes Income taxes are recorded in accordance with FASB ASC Topic 740, 740” not not may not The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. not not December 31, 2018 2017, not 10 | |
Earnings Per Share, Policy [Policy Text Block] | Net Income (Loss) per Share Attributable to Common Stockholders Basic net income (loss) per share is calculated by dividing net income (loss) attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net income per share is calculated by dividing the net income attributable to common stockholders by the weighted-average number of common equivalent shares outstanding for the period, including any dilutive effect from outstanding stock options and warrants using the treasury stock method. The Company follows the two two two not | Net Income (Loss) per Share Attributable to Common Stockholders Basic net income (loss) per share is calculated by dividing net income (loss) attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net income per share is calculated by dividing the net income attributable to common stockholders by the weighted-average number of common equivalent shares outstanding for the period, including any dilutive effect from outstanding stock options and warrants using the treasury stock method. The Company follows the two two two not |
Comprehensive Income, Policy [Policy Text Block] | Comprehensive Loss Comprehensive loss consists of net income or loss and changes in equity during a period from transactions and other events and circumstances generated from non-owner sources. The Company's net loss equals comprehensive loss, net of any changes in the unrealized gains and losses of the Company's short-term investments, held as available-for-sale, and foreign currency translation for all periods presented. | |
Subsequent Events, Policy [Policy Text Block] | Subsequent Events The Company considers events or transactions that occur after the balance sheet date but prior to the date the consolidated financial statements are available to be issued for potential recognition or disclosure in the financial statements. The Company has completed an evaluation of all subsequent events after the consolidated balance sheet date of December 31, 2018 December 31, 2018 not |
Note 2 - Summary of Significa_2
Note 2 - Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Property Plant and Equipment Useful Lives [Table Text Block] | Asset Estimated Useful Life (in years) Computer equipment and software 3 Furniture, fixtures and other 5 Laboratory equipment 7 |
Note 3 - Fair Value Measureme_2
Note 3 - Fair Value Measurements (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes Tables | ||
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | As of September 30, 2019 Quoted Prices Significant Significant Total Assets Cash equivalents $ 9,101 $ - $ - $ 9,101 Total $ 9,101 $ - $ - $ 9,101 As of December 31, 2018 Quoted Prices Significant Significant Total Assets Cash equivalents $ 18,353 $ - $ - $ 18,353 Government securities 2,496 - - 2,496 Total $ 20,849 $ - $ - $ 20,849 | As of December 31, 2018 Quoted Prices Significant Significant in Active Observable Unobservable Markets Inputs Inputs (Level 1) (Level 2) (Level 3) Total Assets Cash equivalents $ 18,353 $ - $ - $ 18,353 Government securities 2,496 - - 2,496 Total $ 20,849 $ - $ - $ 20,849 As of December 31, 2017 Quoted Prices Significant Significant in Active Observable Unobservable Markets Inputs Inputs (Level 1) (Level 2) (Level 3) Total Assets Cash equivalents $ 11,662 $ - $ - $ 11,662 Government securities 20,971 - - 20,971 Total $ 32,633 $ - $ - $ 32,633 |
Available-for-sale Securities [Table Text Block] | Amortized Cost Unrealized Gains Unrealized Losses Fair Value September 30, 2019 Government securities (Due within 1 year) $ - $ - $ - $ - $ - $ - $ - $ - December 31, 2018 Government securities (Due within 1 year) $ 2,496 $ - $ - $ 2,496 $ 2,496 $ - $ - $ 2,496 | Amortized Cost Unrealized Gains Unrealized Losses Fair Value December 31, 2018 Government securities (Due within 1 year) $ 2,496 $ - $ - $ 2,496 $ 2,496 $ - $ - $ 2,496 December 31, 2017 Government securities (Due within 1 year) $ 20,991 $ - $ (20 ) $ 20,971 $ 20,991 $ - $ (20 ) $ 20,971 |
Note 4 - Property and Equipme_2
Note 4 - Property and Equipment, Net (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes Tables | ||
Property, Plant and Equipment [Table Text Block] | As of September 30, 2019 December 31, 2018 Computer equipment and software $ - $ 211 Furniture, fixtures, and other - 365 Laboratory equipment - 514 - 1,090 Accumulated depreciation - (827 ) Property and equipment, net $ - $ 263 | As of December 31, 2018 2017 Computer equipment and software $ 211 $ 192 Furniture, fixtures, and other 365 302 Laboratory equipment 514 477 1,090 971 Accumulated depreciation (827 ) (712 ) Property and equipment, net $ 263 $ 259 |
Note 5 - Accrued Expenses (Tabl
Note 5 - Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Schedule of Accrued Liabilities [Table Text Block] | As of December 31, 2018 2017 Payroll and employee-related costs $ 1,390 $ 1,318 Contracted service costs 968 7,218 Professional fees and other 279 413 Total $ 2,637 $ 8,949 |
Note 6 - Commitments and Cont_2
Note 6 - Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block] | Year Ending December 31: Amount 2019 207 Total minimum lease payments $ 207 |
Note 8 - Common Stock (Tables)
Note 8 - Common Stock (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes Tables | ||
Common Stock Reserved for Future Issuance [Table Text Block] | September 30, December 31, 2019 2018 Conversion of Series A Preferred Stock 21,771,032 22,112,775 Stock-based compensation awards 6,818,214 5,163,957 Employee Stock Purchase Plan 118,120 118,120 Total 28,707,366 27,394,852 | December 31, December 31, 2018 2017 Conversion of Series A Preferred Stock 22,112,775 22,112,775 Stock-based compensation awards 5,163,957 3,572,457 Employee Stock Purchase Plan 118,120 192,463 Total 27,394,852 25,877,695 |
Note 9 - Stock-based Compensa_2
Note 9 - Stock-based Compensation (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes Tables | ||
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | Year Ended December 31, 2018 2017 2016 Research and development $ 1,142 $ 1,109 $ 1,114 General and administrative 2,287 2,118 2,229 Total $ 3,429 $ 3,227 $ 3,343 | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Year Ended December 31, 2018 2017 2016 Weighted average expected volatility 93.5 % 94.5 % 84.4 % Expected term (in years) 6.07 6.06 6.05 Risk free interest rate 2.55 % 2.09 % 1.45 % Expected dividend yield 0 % 0 % 0 % | |
Share-based Payment Arrangement, Option, Activity [Table Text Block] | Options Weighted- Weighted- Aggregate Outstanding at December 31, 2018 4,597,226 $ 5.12 7.4 $ 404 Granted 1,182,500 $ 2.66 Exercised - Forfeited (1) (2,606,289 ) $ 2.79 Expired (1) (2,400,590 ) $ 6.51 Outstanding at September 30, 2019 772,847 $ 4.89 7.3 $ - Exercisable at September 30, 2019 476,390 $ 6.13 6.4 $ - Vested or expected to vest at September 30, 2019 (2) 772,847 $ 4.89 7.3 $ - | Options Weighted- Weighted- Aggregate Outstanding at December 31, 2017 2,681,072 $ 7.18 6.8 $ 121 Granted 2,041,600 $ 2.61 Exercised - Forfeited (83,433 ) $ 5.82 Expired (42,013 ) $ 13.30 Outstanding at December 31, 2018 4,597,226 $ 5.12 7.4 $ 404 Exercisable at December 31, 2018 2,067,356 $ 7.57 5.7 $ 241 Vested or expected to vest at December 31, 2018 (1) 4,597,226 $ 5.12 7.4 $ 404 |
Note 10 - Income Taxes (Tables)
Note 10 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Schedule of Income before Income Tax, Domestic and Foreign [Table Text Block] | Year Ended December 31, 2018 2017 2016 Domestic $ (17,855 ) $ (24,803 ) $ (15,860 ) Foreign (2,874 ) (5,161 ) (12,666 ) Total $ (20,729 ) $ (29,964 ) $ (28,526 ) |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | Year Ended December 31, 2018 2017 2016 Income tax benefit computed at federal statutory tax rate $ (4,348 ) $ (10,186 ) $ (9,696 ) Permanent differences 6 4 430 Stock compensation - permanent items 325 689 - R&D credit - permanent items - 1,751 1,437 State income taxes, net of federal benefit (958 ) (853 ) (498 ) Tax credits (1,466 ) (5,495 ) (4,846 ) Change in valuation allowance 5,409 (54,319 ) 8,804 Foreign rate differential 602 1,752 4,304 Rate change - 2,202 - 382 limitation - 64,975 - Other 430 (520 ) 65 Total $ - $ - $ - |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | Year Ended December 31, 2018 2017 2016 Deferred tax assets: Net operating loss carryforwards $ 6,742 $ 2,651 $ 37,237 Federal and state tax credits 3,122 2,244 21,223 Accrued expenses 411 399 544 Patents 132 191 360 Stock-based compensation 1,782 1,262 1,353 Other 169 202 321 Total deferred tax assets 12,358 6,949 61,038 Valuation allowance (12,358 ) (6,949 ) (61,038 ) Net deferred assets $ - $ - $ - |
Note 11 - Net Loss Per Share _2
Note 11 - Net Loss Per Share Attributable to Common Stockholders (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes Tables | ||
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Outstanding stock options 772,847 4,597,226 772,847 4,597,226 Outstanding ESPP shares - 26,642 - 26,642 Convertible preferred stock 21,771,032 22,112,775 21,771,032 22,112,775 22,543,879 26,736,643 22,543,879 26,736,643 | Year Ended December 31, 2018 2017 2016 Outstanding stock options 4,597,226 2,681,072 2,166,254 Convertible preferred stock 22,112,775 22,112,775 - 26,710,001 24,793,847 2,166,254 |
Note 12 - Quarterly Financial_2
Note 12 - Quarterly Financial Information (Unaudited, in Thousands, Except Share and Per Share Data) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Notes Tables | |
Quarterly Financial Information [Table Text Block] | Three Months Ended (a) March 31, June 30, September 30, December 31, 2018 2018 2018 2018 Operating expenses $ 6,365 $ 5,000 $ 4,622 $ 5,385 Net loss attributable to common stockholders (6,081 ) (4,879 ) (4,510 ) (5,259 ) Net loss per share attributable to common stockholders: Basic and Diluted $ (0.34 ) $ (0.28 ) $ (0.25 ) $ (0.27 ) Weighted-average common shares outstanding used in net loss per share attributable to common stockholders: Basic and Diluted 17,674,729 17,674,729 17,824,186 19,221,292 Three Months Ended (a) March 31, June 30, September 30, December 31, 2017 2017 2017 2017 Operating expenses $ 6,480 $ 5,986 $ 12,306 $ 5,590 Net loss attributable to common stockholders (6,498 ) (5,608 ) (19,054 ) (5,551 ) Net loss per share attributable to common stockholders: Basic and Diluted $ (0.39 ) $ (0.33 ) $ (1.08 ) $ (0.33 ) Weighted-average common shares outstanding used in net loss per share attributable to common stockholders: Basic and Diluted 16,636,201 17,207,672 17,619,418 (b) 17,619,418 |
Note 1 - Organization and Ope_2
Note 1 - Organization and Operations (Details Textual) - USD ($) | Aug. 02, 2017 | Nov. 12, 2015 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2019 |
Cash, Cash Equivalents, and Short-term Investments, Total | $ 21,900,000 | $ 9,300,000 | ||||
Retained Earnings (Accumulated Deficit), Ending Balance | $ (210,470,000) | $ (189,741,000) | $ (223,852,000) | |||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | $ 0.001 | |||
Series A Convertible Preferred Stock [Member] | ||||||
Stock Issued During Period, Shares, New Issues | 22,000 | |||||
Payments of Stock Issuance Costs | $ 500,000 | |||||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | $ 0.001 | |||
Shares Issued, Price Per Share | $ 1,000 | |||||
Proceeds from Issuance of Convertible Preferred Stock | $ 22,000,000 | |||||
Common Stock [Member] | ||||||
Stock Issued During Period, Shares, New Issues | 1,494,579 | 1,494,579 | 896,811 | |||
Sales Agreement [Member] | Cowen and Company, LLC [Member] | Common Stock [Member] | ||||||
Sale of Stock, Maximum Value of Stock Offered | $ 40,000,000 | |||||
Sale of Stock, Commission to Sales Agent, Percentage | 3.00% | |||||
Stock Issued During Period, Shares, New Issues | 896,811 | |||||
Proceeds from Issuance of Common Stock | $ 1,400,000 | |||||
Payments of Stock Issuance Costs | $ 100,000 | |||||
Sales Agreement [Member] | New Leaf Venture Partners LLC [Member] | Common Stock [Member] | ||||||
Stock Issued During Period, Shares, New Issues | 1,494,579 | |||||
Proceeds from Issuance of Common Stock | $ 3,000,000 | |||||
Payments of Stock Issuance Costs | $ 46,000 |
Note 2 - Summary of Significa_3
Note 2 - Summary of Significant Accounting Policies - Property and Equipment Useful Lives (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Computer Equipment and Software [Member] | |
Property and equipment, useful life (Year) | 3 years |
Furniture and Fixtures [Member] | |
Property and equipment, useful life (Year) | 5 years |
Laboratory Equipment [Member] | |
Property and equipment, useful life (Year) | 7 years |
Note 2 - Summary of Significa_4
Note 2 - Summary of Significant Accounting Policies (Details Textual) | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Number of Operating Segments | 1 | ||||
Number of Reportable Segments | 1 | ||||
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents, Period Increase (Decrease), Including Exchange Rate Effect, Total | $ (10,022,000) | $ (2,945,000) | $ (1,799,000) | $ (15,222,000) | $ (3,639,000) |
Restricted Cash and Cash Equivalents, Total | 22,000 | 22,000 | 22,000 | 22,000 | |
Available-for-sale Securities, Gross Realized Gain (Loss), Total | 0 | 0 | 0 | ||
Other than Temporary Impairment Losses, Investments, Available-for-sale Securities, Total | 0 | 0 | $ 0 | ||
Liability for Uncertainty in Income Taxes, Current | 0 | 0 | |||
Accounting Standards Update 2016-18 [Member] | |||||
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents, Period Increase (Decrease), Including Exchange Rate Effect, Total | $ 22,000 | $ 22,000 | $ 22,000 | $ 14,000 |
Note 3 - Fair Value Measureme_3
Note 3 - Fair Value Measurements - Summary of Assets and Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Total | $ 9,101 | $ 20,849 | $ 32,633 |
Cash Equivalents [Member] | |||
Cash equivalents | 9,101 | 18,353 | 11,662 |
US Government Agencies Debt Securities [Member] | |||
Government securities | 2,496 | 20,971 | |
Fair Value, Inputs, Level 1 [Member] | |||
Total | 9,101 | 20,849 | 32,633 |
Fair Value, Inputs, Level 1 [Member] | Cash Equivalents [Member] | |||
Cash equivalents | 9,101 | 18,353 | 11,662 |
Fair Value, Inputs, Level 1 [Member] | US Government Agencies Debt Securities [Member] | |||
Government securities | 2,496 | 20,971 | |
Fair Value, Inputs, Level 2 [Member] | |||
Total | |||
Fair Value, Inputs, Level 2 [Member] | Cash Equivalents [Member] | |||
Cash equivalents | |||
Fair Value, Inputs, Level 2 [Member] | US Government Agencies Debt Securities [Member] | |||
Government securities | |||
Fair Value, Inputs, Level 3 [Member] | |||
Total | |||
Fair Value, Inputs, Level 3 [Member] | Cash Equivalents [Member] | |||
Cash equivalents | |||
Fair Value, Inputs, Level 3 [Member] | US Government Agencies Debt Securities [Member] | |||
Government securities |
Note 3 - Fair Value Measureme_4
Note 3 - Fair Value Measurements - Available-for-sale Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Amortized Cost | $ 2,496 | $ 20,991 | |
Unrealized Gains | |||
Unrealized Losses | (20) | ||
Fair Value | 2,496 | 20,971 | |
US Government Agencies Debt Securities [Member] | |||
Amortized Cost | 2,496 | 20,991 | |
Unrealized Gains | |||
Unrealized Losses | (20) | ||
Fair Value | $ 2,496 | $ 20,971 |
Note 4 - Property and Equipme_3
Note 4 - Property and Equipment, Net - Summary of Property and Equipment (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Property and equipment | $ 1,090,000 | $ 971,000 | |
Accumulated depreciation | (827,000) | (712,000) | |
Property and equipment, net | 0 | 263,000 | 259,000 |
Computer Equipment and Software [Member] | |||
Property and equipment | 211,000 | 192,000 | |
Furniture and Fixtures [Member] | |||
Property and equipment | 365,000 | 302,000 | |
Laboratory Equipment [Member] | |||
Property and equipment | $ 514,000 | $ 477,000 |
Note 4 - Property and Equipme_4
Note 4 - Property and Equipment, Net (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Depreciation, Total | $ 100,000 | $ 22,000 | $ 279,000 | $ 83,000 | $ 115,000 | $ 148,000 | $ 123,000 |
Note 5 - Accrued Expenses - Acc
Note 5 - Accrued Expenses - Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Payroll and employee-related costs | $ 1,390 | $ 1,318 | |
Contracted service costs | 968 | 7,218 | |
Professional fees and other | 279 | 413 | |
Total | $ 1,219 | $ 2,637 | $ 8,949 |
Note 6 - Commitments and Cont_3
Note 6 - Commitments and Contingencies - Future Minimum Payments for Operating Leases (Details) $ in Thousands | Dec. 31, 2018USD ($) |
2019 | $ 207 |
Total minimum lease payments | $ 207 |
Note 6 - Commitments and Cont_4
Note 6 - Commitments and Contingencies (Details Textual) | 1 Months Ended | 12 Months Ended | |||||
Aug. 31, 2017ft² | Feb. 28, 2002 | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | |
Royalty Payment, Percentage of Net Sales | 2.50% | ||||||
Lessee, Operating Lease, Term of Contract | 1 year 90 days | ||||||
Operating Leases, Increase in Office Space | ft² | 2,552 | ||||||
Area of Real Estate Property | ft² | 7,500 | ||||||
Lessee, Operating Lease, Renewal Term | 1 year | ||||||
Operating Leases, Notice Required to Extend Term | 180 days | ||||||
Operating Leases, Rent Expense, Total | $ 300,000 | $ 200,000 | $ 200,000 | ||||
Security Deposit | 22,000 | $ 22,000 | |||||
Letters of Credit Outstanding, Amount | 22,000 | 22,000 | $ 22,000 | ||||
Loans Pledged as Collateral | $ 22,000 | $ 22,000 | $ 22,000 |
Note 7 - Series A Preferred F_2
Note 7 - Series A Preferred Financing (Details Textual) - USD ($) | Aug. 02, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2019 |
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | $ 0.001 | ||
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 | 10,000,000 | ||
Accretion of Redeemable Convertible Preferred Stock to Redemption Value | $ 6,747,000 | ||||
Series A Convertible Preferred Stock [Member] | |||||
Stock Issued During Period, Shares, New Issues | 22,000 | ||||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | $ 0.001 | ||
Shares Issued, Price Per Share | $ 1,000 | ||||
Proceeds from Issuance of Convertible Preferred Stock | $ 22,000,000 | ||||
Payments of Stock Issuance Costs | $ 500,000 | ||||
Convertible Preferred Stock, Shares Issued upon Conversion | 1,005 | ||||
Convertible Preferred Stock, Conversion Price of Shares Issued upon Conversion | $ 0.9949 | ||||
Convertible Preferred Stock, Maximum Ownership Percentage Allowed after Conversion of Stock | 9.985% | ||||
Preferred Stock, Shares Authorized | 22,000 | 22,000 | 22,000 | ||
Preferred Stock, Redemption Price Per Share | $ 1.30 | ||||
Accretion of Redeemable Convertible Preferred Stock to Redemption Value | $ 6,700,000 | ||||
Preferred Stock, Liquidation Preference Per Share | $ 0.001 |
Note 8 - Common Stock - Common
Note 8 - Common Stock - Common Stock Reserved for Future Issuance (Details) - shares | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2014 |
Reserved for future issuance (in shares) | 28,707,366 | 27,394,852 | 25,877,695 | |
The 2014 Employee Stock Purchase Plan [Member] | ||||
Reserved for future issuance (in shares) | 118,120 | 118,120 | 192,463 | 140,500 |
Performance Shares [Member] | ||||
Reserved for future issuance (in shares) | 6,818,214 | 5,163,957 | 3,572,457 | |
Conversion of Series A Preferred Stock to Common Stock [Member] | ||||
Reserved for future issuance (in shares) | 21,771,032 | 22,112,775 | 22,112,775 |
Note 8 - Common Stock (Details
Note 8 - Common Stock (Details Textual) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Common Stock, Shares Authorized | 100,000,000 | 100,000,000 | 100,000,000 |
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | $ 0.001 |
Common Stock, Shares, Issued, Total | 19,585,394 | 19,243,651 | 17,674,729 |
Common Stock, Shares, Outstanding, Ending Balance | 19,585,394 | 19,243,651 | 17,674,729 |
Note 9 - Stock-based Compensa_3
Note 9 - Stock-based Compensation - Black-scholes Valuation Assumptions (Details) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Weighted average expected volatility | 93.50% | 94.50% | 84.40% |
Expected term (in years) (Year) | 6 years 25 days | 6 years 21 days | 6 years 18 days |
Risk free interest rate | 2.55% | 2.09% | 1.45% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Note 9 - Stock-based Compensa_4
Note 9 - Stock-based Compensation (Details Textual) - USD ($) | Jan. 01, 2019 | Jan. 01, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2014 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 6 years 146 days | 5 years 255 days | ||||||||
Allocated Share-based Compensation Expense, Total | $ 96,000 | $ 904,000 | $ 977,000 | $ 2,647,000 | $ 3,429,000 | $ 3,227,000 | $ 3,343,000 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 1,182,500 | 2,041,600 | 719,337 | 132,495 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 2.61 | $ 1.99 | $ 5.08 | |||||||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 2.66 | $ 2.61 | $ 7.11 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 0 | $ 27,000 | ||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 4,600,000 | $ 4,200,000 | ||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 146 days | 2 years 146 days | ||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 28,707,366 | 28,707,366 | 27,394,852 | 25,877,695 | ||||||
Employee Stock Option [Member] | Non-Employees [Member] | ||||||||||
Allocated Share-based Compensation Expense, Total | $ 0 | $ 0 | $ 0 | |||||||
The 2014 Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 704,000 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Annual Additional Shares, Percentage | 4.00% | |||||||||
The 2014 Plan [Member] | Minimum [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 3 years | |||||||||
The 2014 Plan [Member] | Maximum [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 4 years | |||||||||
The 2006 Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 10 years | |||||||||
The 2014 Employee Stock Purchase Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 192,436 | 192,436 | 304,991 | 140,500 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Annual Additional Shares, Percentage | 1.00% | 1.00% | ||||||||
Allocated Share-based Compensation Expense, Total | $ 100,000 | $ 100,000 | $ 100,000 | |||||||
Common Stock, Capital Shares Reserved for Future Issuance | 118,120 | 118,120 | 118,120 | 192,463 | 140,500 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Maximum Number of Additional Shares Authorizable | 281,000 | 281,000 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 0 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued in Period | 0 | 0 | 74,343 | 100,358 |
Note 9 - Stock-based Compensa_5
Note 9 - Stock-based Compensation - Stock-based Compensation Expense Recognized for Stock Options Granted (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Allocated share-based compensation | $ 96 | $ 904 | $ 977 | $ 2,647 | $ 3,429 | $ 3,227 | $ 3,343 |
Research and Development Expense [Member] | |||||||
Allocated share-based compensation | (26) | 298 | 233 | 877 | 1,142 | 1,109 | 1,114 |
General and Administrative Expense [Member] | |||||||
Allocated share-based compensation | $ 122 | $ 606 | $ 744 | $ 1,770 | $ 2,287 | $ 2,118 | $ 2,229 |
Note 9 - Stock-based Compensa_6
Note 9 - Stock-based Compensation - Stock Option Activity for Employees and Non-employees (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |||
Options Outstanding, Beginning Balance (in shares) | 4,597,226 | 2,681,072 | ||||
Options Outstanding, Weighted Average Exercise Price, Beginning Balance (in dollars per share) | $ 5.12 | $ 7.18 | ||||
Options Outstanding, Weighted-average Remaining Contractual Term (Year) | 7 years 109 days | 7 years 146 days | 6 years 292 days | |||
Options Outstanding, Aggregate Intrinsic Value | $ 404 | $ 121 | ||||
Options Granted (in shares) | 1,182,500 | 2,041,600 | 719,337 | 132,495 | ||
Options Granted, Weighted Average Exercise Price (in dollars per share) | $ 2.66 | $ 2.61 | $ 7.11 | |||
Options Exercised, Weighted Average Exercise Price (in dollars per share) | ||||||
Options Forfeited (in shares) | (2,606,289) | [1] | (83,433) | |||
Options Forfeited, Weighted Average Exercise Price (in dollars per share) | $ 2.79 | [1] | $ 5.82 | |||
Options Expired (in shares) | (2,400,590) | [1] | (42,013) | |||
Options Expired, Weighted Average Exercise Price (in dollars per share) | $ 6.51 | [1] | $ 13.30 | |||
Options Outstanding, Ending Balance (in shares) | 772,847 | 4,597,226 | 2,681,072 | |||
Options Outstanding, Weighted Average Exercise Price, Ending Balance (in dollars per share) | $ 4.89 | $ 5.12 | $ 7.18 | |||
Options Exercisable (in shares) | 476,390 | 2,067,356 | ||||
Options Exercisable, Weighted Average Exercise Price (in dollars per share) | $ 6.13 | $ 7.57 | ||||
Options Exercisable, Weighted-average Remaining Contractual Term (Year) | 6 years 146 days | 5 years 255 days | ||||
Options Exercisable, Aggregate Intrinsic Value | $ 241 | |||||
Options Vested or Expected to Vest (in shares) | 772,847 | [2] | 4,597,226 | [3] | ||
Options Vested or Expected to Vest, Weighted Average Exercise Price (in dollars per share) | $ 4.89 | [2] | $ 5.12 | [3] | ||
Options Vested or Expected to Vest, Weighted-average Remaining Contractual Term (Year) | 7 years 109 days | [2] | 7 years 146 days | [3] | ||
Options Vested or Expected to Vest, Aggregate Intrinsic Value | [2] | $ 404 | [3] | |||
[1] | Represents the number of options cancelled during the nine months ended September 30, 2019 as a result of employees that were terminated due to the reduction in force. | |||||
[2] | Represents the number of vested options at September 30, 2019 plus the number of unvested options expected to vest based on the unvested options outstanding at September 30, 2019." | |||||
[3] | Represents the number of vested options at December 31, 2018 plus the number of unvested options expected to vest based on the unvested options outstanding at December 31, 2018. |
Note 10 - Income Taxes - Summar
Note 10 - Income Taxes - Summary of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Net operating loss carryforwards | $ 6,742 | $ 2,651 | $ 37,237 |
Federal and state tax credits | 3,122 | 2,244 | 21,223 |
Accrued expenses | 411 | 399 | 544 |
Patents | 132 | 191 | 360 |
Stock-based compensation | 1,782 | 1,262 | 1,353 |
Other | 169 | 202 | 321 |
Total deferred tax assets | 12,358 | 6,949 | 61,038 |
Valuation allowance | (12,358) | (6,949) | (61,038) |
Net deferred assets |
Note 10 - Income Taxes - Domest
Note 10 - Income Taxes - Domestic and Foreign Loss Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Domestic | $ (17,855) | $ (24,803) | $ (15,860) |
Foreign | (2,874) | (5,161) | (12,666) |
Total | $ (20,729) | $ (29,964) | $ (28,526) |
Note 10 - Income Taxes - Reconc
Note 10 - Income Taxes - Reconciliation of Income Taxes (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income tax benefit computed at federal statutory tax rate | $ (4,348) | $ (10,186) | $ (9,696) | ||
Permanent differences | 6 | 4 | 430 | ||
Stock compensation - permanent items | 325 | 689 | |||
R&D credit - permanent items | 1,751 | 1,437 | |||
State income taxes, net of federal benefit | (958) | (853) | (498) | ||
Tax credits | (1,466) | (5,495) | (4,846) | ||
Change in valuation allowance | 5,409 | (54,319) | 8,804 | ||
Foreign rate differential | 602 | 1,752 | 4,304 | ||
Rate change | 2,202 | ||||
382 limitation | 64,975 | ||||
Other | 430 | (520) | 65 | ||
Total | $ 0 | $ 0 |
Note 10 - Income Taxes (Details
Note 10 - Income Taxes (Details Textual) - USD ($) | Aug. 02, 2017 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Income Tax Expense (Benefit), Total | $ 0 | $ 0 | ||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 34.00% | ||||
Deferred Tax Assets, Increase (Decrease) from Revaluation Due to Tax Rate Change | $ (2,200,000) | |||||
Income Tax Expense (Benefit), Continuing Operations, Adjustment of Deferred Tax (Asset) Liability | 0 | |||||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | (54,100,000) | 8,800,000 | ||||
Operating Loss Carryforwards, Net, Indefinite Lived | $ 14,700,000 | |||||
Tax Credit Carryforward, Amount | 3,100,000 | 2,300,000 | 0 | |||
Unrecognized Tax Benefits, Ending Balance | 0 | 0 | 0 | |||
Current Year Deferred Tax Assets Activity [Member] | ||||||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | 5,400,000 | 13,100,000 | ||||
Effect on Deferred Tax Assets of Section 382 Limitation [Member] | ||||||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | (65,000,000) | |||||
Effect of Tax Rate Change on Deferred Tax Assets [Member] | ||||||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | (2,200,000) | |||||
Series A Preferred Stock [Member] | ||||||
Proceeds from Issuance of Convertible Preferred Stock | $ 22,000,000 | |||||
Domestic Tax Authority [Member] | ||||||
Income Tax Expense (Benefit), Total | 0 | 0 | 0 | |||
Operating Loss Carryforwards, Total | 25,700,000 | 10,600,000 | 0 | |||
Domestic Tax Authority [Member] | Internal Revenue Service (IRS) [Member] | ||||||
Decrease in Net Operating Loss Carryforwards from Section 382 Limitation | 107,300,000 | |||||
Decrease in Net Operating Loss Carryforwards from Section 382 Limitation, Tax Affected | 34,100,000 | |||||
Decrease in Tax Credit Carryforward Amount from Section 382 Limitation | 23,800,000 | |||||
State and Local Jurisdiction [Member] | ||||||
Income Tax Expense (Benefit), Total | 0 | 0 | 0 | |||
Decrease in Net Operating Loss Carryforwards from Section 382 Limitation | 5,000,000 | |||||
Decrease in Tax Credit Carryforward Amount from Section 382 Limitation | $ 2,100,000 | |||||
Operating Loss Carryforwards, Total | $ 21,500,000 | $ 6,800,000 | $ 0 |
Note 11 - Net Loss Per Share _3
Note 11 - Net Loss Per Share Attributable to Common Stockholders - Common Stock Equivalents Excluded From Calculation of Net Loss Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Antidilutive Securities (in shares) | 22,543,879 | 26,736,643 | 22,543,879 | 26,736,643 | 26,710,001 | 24,793,847 | 2,166,254 |
Convertible Preferred Stock [Member] | |||||||
Antidilutive Securities (in shares) | 21,771,032 | 22,112,775 | 21,771,032 | 22,112,775 | 22,112,775 | 22,112,775 | |
Employee Stock Option [Member] | |||||||
Antidilutive Securities (in shares) | 772,847 | 4,597,226 | 772,847 | 4,597,226 | 4,597,226 | 2,681,072 | 2,166,254 |
Note 11 - Net Loss Per Share _4
Note 11 - Net Loss Per Share Attributable to Common Stockholders (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Accretion of Redeemable Convertible Preferred Stock to Redemption Value | $ 6,747 |
Note 12 - Quarterly Financial_3
Note 12 - Quarterly Financial Information (Unaudited, in Thousands, Except Share and Per Share Data) - Quarterly Financial Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||||||||||||
Sep. 30, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | ||||||||||
us-gaap_OperatingExpenses | $ 1,591 | $ 5,385 | [1] | $ 4,622 | [1] | $ 5,000 | [1] | $ 6,365 | [1] | $ 5,590 | [1] | $ 12,306 | [1] | $ 5,986 | [1] | $ 6,480 | [1] | $ 13,614 | $ 15,987 | $ 21,372 | $ 30,362 | $ 28,705 | |
Net loss attributable to common stockholders | [1] | $ (5,259) | $ (4,510) | $ (4,879) | $ (6,081) | $ (5,551) | $ (19,054) | $ (5,608) | $ (6,498) | ||||||||||||||
Net loss per share attributable to common stockholders - basic and diluted (in dollars per share) | $ (0.08) | $ (0.27) | [1] | $ (0.25) | [1] | $ (0.28) | [1] | $ (0.34) | [1] | $ (0.33) | [1] | $ (1.08) | [1] | $ (0.33) | [1] | $ (0.39) | [1] | $ (0.69) | $ (0.87) | $ (1.15) | $ (2.13) | $ (1.72) | |
Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted (in shares) | 19,585,394 | 19,221,292 | [1] | 17,824,186 | [1] | 17,674,729 | [1] | 17,674,729 | [1] | 17,619,418 | [1] | 17,619,418 | [1],[2] | 17,207,672 | [1] | 16,636,201 | [1] | 19,476,487 | 17,725,095 | 18,102,219 | 17,274,326 | 16,561,799 | |
[1] | The amounts were computed independently for each quarter, and the sum of the quarters may not total the annual amounts. | ||||||||||||||||||||||
[2] | Adjusted to correct an immaterial error in the weighted-average share calculation in the Company's Form 10-Q as of September 30, 2017. |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | |||
Cash and cash equivalents | $ 9,349,000 | $ 19,371,000 | $ 21,170,000 |
Restricted cash | 22,000 | ||
Available-for-sale investments | 2,496,000 | 20,971,000 | |
Prepaid expenses and other current assets | 277,000 | 1,369,000 | 1,339,000 |
Total current assets | 9,648,000 | 23,236,000 | 43,480,000 |
Property and equipment, net | 0 | 263,000 | 259,000 |
Restricted cash | 22,000 | 22,000 | |
Total assets | 9,648,000 | 23,521,000 | 43,979,000 |
Current liabilities: | |||
Accounts payable | 394,000 | 441,000 | 291,000 |
Accrued expenses | 1,219,000 | 2,637,000 | 8,949,000 |
Total current liabilities | 1,613,000 | 3,078,000 | 9,240,000 |
Total liabilities | 1,613,000 | 3,078,000 | 9,240,000 |
Commitments and contingencies (Note 5) | |||
Preferred stock, $0.001 par value per share; 10,000,000 shares authorized at September 30, 2019 and December 31, 2018: Series A convertible preferred stock 22,000 shares authorized at September 30, 2019 and December 31, 2018; 21,660 and 22,000 issued and outstanding at September 30, 2019 and at December 31, 2018, respectively | |||
Common stock, $0.001 par value, 100,000,000 shares authorized at September 30, 2019 and December 31, 2018; 19,585,394 and 19,243,651 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 19,000 | 19,000 | 18,000 |
Additional paid-in capital | 210,683,000 | 209,366,000 | 202,953,000 |
Accumulated deficit | (223,852,000) | (210,470,000) | (189,741,000) |
Accumulated other comprehensive income | 2,000 | 5,000 | (14,000) |
Total stockholders’ equity | 8,035,000 | 20,443,000 | 34,739,000 |
Total liabilities and stockholders’ equity | 9,648,000 | 23,521,000 | 43,979,000 |
Series A Convertible Preferred Stock [Member] | |||
Current liabilities: | |||
Preferred stock, $0.001 par value per share; 10,000,000 shares authorized at September 30, 2019 and December 31, 2018: Series A convertible preferred stock 22,000 shares authorized at September 30, 2019 and December 31, 2018; 21,660 and 22,000 issued and outstanding at September 30, 2019 and at December 31, 2018, respectively | $ 21,183,000 | $ 21,523,000 | $ 21,523,000 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Aug. 02, 2017 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | 10,000,000 | |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 | 100,000,000 | |
Common stock, shares issued (in shares) | 19,585,394 | 19,243,651 | 17,674,729 | |
Common stock, shares outstanding (in shares) | 19,585,394 | 19,243,651 | 17,674,729 | |
Series A Convertible Preferred Stock [Member] | ||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |
Preferred stock, shares authorized (in shares) | 22,000 | 22,000 | 22,000 | |
Preferred stock, shares issued (in shares) | 21,660 | 22,000 | 22,000 | |
Preferred stock, shares outstanding (in shares) | 21,660 | 22,000 | 22,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||||||||||||||
Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | [1] | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | [1] | Sep. 30, 2017 | [1] | Jun. 30, 2017 | [1] | Mar. 31, 2017 | [1] | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | ||||
Operating expenses: | ||||||||||||||||||||||||
Research and development | $ 206 | $ 2,354 | $ 6,374 | $ 9,185 | $ 11,848 | $ 21,686 | $ 18,869 | |||||||||||||||||
General and administrative | 1,385 | 2,268 | 7,240 | 6,802 | 9,524 | 8,676 | 9,836 | |||||||||||||||||
Total operating expenses | 1,591 | $ 5,385 | 4,622 | [1] | $ 5,000 | [1] | $ 6,365 | [1] | $ 5,590 | $ 12,306 | $ 5,986 | $ 6,480 | 13,614 | 15,987 | 21,372 | 30,362 | 28,705 | |||||||
Loss from operations | (1,591) | (4,622) | (13,614) | (15,987) | (21,372) | (30,362) | (28,705) | |||||||||||||||||
Other income: | ||||||||||||||||||||||||
Investment income | 53 | 113 | 231 | 311 | 436 | 259 | 193 | |||||||||||||||||
Other income (expense), net | 2 | (1) | 1 | 206 | 207 | 139 | (14) | |||||||||||||||||
Total other income | 55 | 112 | 232 | 517 | 643 | 398 | 179 | |||||||||||||||||
Net loss | (1,536) | $ (5,315) | $ (6,531) | (4,510) | (4,879) | (6,081) | (13,382) | (15,470) | (20,729) | (29,964) | (28,526) | |||||||||||||
Foreign currency translation adjustment | (2) | (3) | (1) | (1) | 6 | |||||||||||||||||||
Unrealized gain on available-for-sale investments | 3 | 19 | 20 | (20) | 11 | |||||||||||||||||||
Comprehensive loss | (1,538) | (4,507) | (13,385) | (15,452) | (20,710) | (29,978) | (28,515) | |||||||||||||||||
Reconciliation of net loss to net loss attributable to common stockholders: | ||||||||||||||||||||||||
Net loss | (1,536) | $ (5,315) | $ (6,531) | (4,510) | $ (4,879) | $ (6,081) | (13,382) | (15,470) | (20,729) | (29,964) | (28,526) | |||||||||||||
Net loss attributable to common stockholders | $ (1,536) | $ (4,510) | $ (13,382) | $ (15,470) | $ (20,729) | $ (36,711) | $ (28,526) | |||||||||||||||||
Net loss per share attributable to common stockholders - basic and diluted (in dollars per share) | $ (0.08) | $ (0.27) | $ (0.25) | [1] | $ (0.28) | [1] | $ (0.34) | [1] | $ (0.33) | $ (1.08) | $ (0.33) | $ (0.39) | $ (0.69) | $ (0.87) | $ (1.15) | $ (2.13) | $ (1.72) | |||||||
Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted (in shares) | 19,585,394 | 19,221,292 | 17,824,186 | [1] | 17,674,729 | [1] | 17,674,729 | [1] | 17,619,418 | 17,619,418 | [2] | 17,207,672 | 16,636,201 | 19,476,487 | 17,725,095 | 18,102,219 | 17,274,326 | 16,561,799 | ||||||
Included in operating expenses, above, are the following amounts for non-cash stock-based compensation expense: | ||||||||||||||||||||||||
Allocated share-based compensation | $ 96 | $ 904 | $ 977 | $ 2,647 | $ 3,429 | $ 3,227 | $ 3,343 | |||||||||||||||||
Research and Development Expense [Member] | ||||||||||||||||||||||||
Included in operating expenses, above, are the following amounts for non-cash stock-based compensation expense: | ||||||||||||||||||||||||
Allocated share-based compensation | (26) | 298 | 233 | 877 | 1,142 | 1,109 | 1,114 | |||||||||||||||||
General and Administrative Expense [Member] | ||||||||||||||||||||||||
Included in operating expenses, above, are the following amounts for non-cash stock-based compensation expense: | ||||||||||||||||||||||||
Allocated share-based compensation | $ 122 | $ 606 | $ 744 | $ 1,770 | $ 2,287 | $ 2,118 | $ 2,229 | |||||||||||||||||
[1] | The amounts were computed independently for each quarter, and the sum of the quarters may not total the annual amounts. | |||||||||||||||||||||||
[2] | Adjusted to correct an immaterial error in the weighted-average share calculation in the Company's Form 10-Q as of September 30, 2017. |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Preferred Stock [Member]Series A Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member]Series A Preferred Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Series A Preferred Stock [Member] | Total |
Balance (in shares) at Dec. 31, 2015 | 16,501,500 | |||||||
Balance at Dec. 31, 2015 | $ 16 | $ 194,651 | $ (131,251) | $ (11) | $ 63,405 | |||
Stock-based compensation expense | 3,343 | 3,343 | ||||||
Net loss | (28,526) | (28,526) | ||||||
Issuance of common stock upon ESPP purchase | 11 | 11 | ||||||
Issuance of common stock upon ESPP purchase (in shares) | 4,538 | |||||||
Balance (in shares) at Dec. 31, 2016 | 16,603,559 | |||||||
Balance at Dec. 31, 2016 | $ 17 | 198,201 | (159,777) | 38,441 | ||||
Stock-based compensation expense | 3,227 | 3,227 | ||||||
Other comprehensive gain/(loss) | (14) | (14) | ||||||
Net loss | (29,964) | (29,964) | ||||||
Issuance of common stock upon ESPP purchase | 130 | 130 | ||||||
Issuance of common stock upon ESPP purchase (in shares) | 100,358 | |||||||
Issuance of common stock, net of issuance costs (in shares) | 22,000 | 896,811 | ||||||
Issuance of common stock, net of issuance costs | $ 14,776 | $ 1 | $ 6,747 | 1,287 | $ 21,523 | 1,288 | ||
Balance (in shares) at Dec. 31, 2017 | 22,000 | 17,674,729 | ||||||
Balance at Dec. 31, 2017 | $ 21,523 | $ 18 | 202,953 | (189,741) | (14) | 34,739 | ||
Stock-based compensation expense | 821 | 821 | ||||||
Other comprehensive gain/(loss) | 10 | 10 | ||||||
Net loss | (6,081) | (6,081) | ||||||
Issuance of common stock upon ESPP purchase | ||||||||
Balance (in shares) at Mar. 31, 2018 | 22,000 | 17,674,729 | ||||||
Balance at Mar. 31, 2018 | $ 21,523 | $ 18 | 203,774 | (195,822) | (4) | 29,489 | ||
Balance (in shares) at Dec. 31, 2017 | 22,000 | 17,674,729 | ||||||
Balance at Dec. 31, 2017 | $ 21,523 | $ 18 | 202,953 | (189,741) | (14) | 34,739 | ||
Net loss | (15,470) | |||||||
Balance (in shares) at Sep. 30, 2018 | 22,000 | 19,221,292 | ||||||
Balance at Sep. 30, 2018 | $ 21,523 | $ 19 | 208,536 | (205,211) | 4 | 24,871 | ||
Balance (in shares) at Dec. 31, 2017 | 22,000 | 17,674,729 | ||||||
Balance at Dec. 31, 2017 | $ 21,523 | $ 18 | 202,953 | (189,741) | (14) | 34,739 | ||
Stock-based compensation expense | 3,429 | 3,429 | ||||||
Other comprehensive gain/(loss) | 19 | 19 | ||||||
Net loss | (20,729) | (20,729) | ||||||
Issuance of common stock upon ESPP purchase | 132 | 132 | ||||||
Issuance of common stock upon ESPP purchase (in shares) | 74,343 | |||||||
Issuance of common stock, net of issuance costs (in shares) | 1,494,579 | |||||||
Issuance of common stock, net of issuance costs | $ 1 | 2,852 | 2,853 | |||||
Balance (in shares) at Dec. 31, 2018 | 22,000 | 19,243,651 | ||||||
Balance at Dec. 31, 2018 | $ 21,523 | $ 19 | 209,366 | (210,470) | 5 | 20,443 | ||
Balance (in shares) at Mar. 31, 2018 | 22,000 | 17,674,729 | ||||||
Balance at Mar. 31, 2018 | $ 21,523 | $ 18 | 203,774 | (195,822) | (4) | 29,489 | ||
Stock-based compensation expense | 922 | 922 | ||||||
Other comprehensive gain/(loss) | 5 | 5 | ||||||
Net loss | (4,879) | (4,879) | ||||||
Issuance of common stock upon ESPP purchase | 84 | 84 | ||||||
Issuance of common stock upon ESPP purchase (in shares) | 51,984 | |||||||
Balance (in shares) at Jun. 30, 2018 | 22,000 | 17,726,713 | ||||||
Balance at Jun. 30, 2018 | $ 21,523 | $ 18 | 204,780 | (200,701) | 1 | 25,621 | ||
Stock-based compensation expense | 904 | 904 | ||||||
Other comprehensive gain/(loss) | 3 | 3 | ||||||
Net loss | (4,510) | (4,510) | ||||||
Issuance of common stock upon ESPP purchase | ||||||||
Issuance of common stock upon ESPP purchase (in shares) | ||||||||
Issuance of common stock, net of issuance costs (in shares) | 1,494,579 | |||||||
Issuance of common stock, net of issuance costs | $ 1 | 2,852 | 2,853 | |||||
Balance (in shares) at Sep. 30, 2018 | 22,000 | 19,221,292 | ||||||
Balance at Sep. 30, 2018 | $ 21,523 | $ 19 | 208,536 | (205,211) | 4 | 24,871 | ||
Balance (in shares) at Dec. 31, 2018 | 22,000 | 19,243,651 | ||||||
Balance at Dec. 31, 2018 | $ 21,523 | $ 19 | 209,366 | (210,470) | 5 | 20,443 | ||
Conversion of Series A convertible preferred stock into Common Stock (in shares) | (340) | |||||||
Conversion of Series A convertible preferred stock into Common Stock | $ (340) | |||||||
Conversion of Series A convertible preferred stock into Common Stock (in shares) | 341,743 | |||||||
Conversion of Series A convertible preferred stock into Common Stock | 340 | |||||||
Stock-based compensation expense | 780 | 780 | ||||||
Other comprehensive gain/(loss) | (2) | (2) | ||||||
Net loss | (6,531) | (6,531) | ||||||
Balance (in shares) at Mar. 31, 2019 | 21,660 | 19,585,394 | ||||||
Balance at Mar. 31, 2019 | $ 21,183 | $ 19 | 210,486 | (217,001) | 3 | 14,690 | ||
Balance (in shares) at Dec. 31, 2018 | 22,000 | 19,243,651 | ||||||
Balance at Dec. 31, 2018 | $ 21,523 | $ 19 | 209,366 | (210,470) | 5 | 20,443 | ||
Net loss | (13,382) | |||||||
Balance (in shares) at Sep. 30, 2019 | 21,660 | 19,585,394 | ||||||
Balance at Sep. 30, 2019 | $ 21,183 | $ 19 | 210,683 | (223,852) | 2 | 8,035 | ||
Balance (in shares) at Mar. 31, 2019 | 21,660 | 19,585,394 | ||||||
Balance at Mar. 31, 2019 | $ 21,183 | $ 19 | 210,486 | (217,001) | 3 | 14,690 | ||
Conversion of Series A convertible preferred stock into Common Stock | ||||||||
Conversion of Series A convertible preferred stock into Common Stock | ||||||||
Stock-based compensation expense | 101 | 101 | ||||||
Other comprehensive gain/(loss) | 1 | 1 | ||||||
Net loss | (5,315) | (5,315) | ||||||
Balance (in shares) at Jun. 30, 2019 | 21,660 | 19,585,394 | ||||||
Balance at Jun. 30, 2019 | $ 21,183 | $ 19 | 210,587 | (222,316) | 4 | 9,477 | ||
Conversion of Series A convertible preferred stock into Common Stock | ||||||||
Conversion of Series A convertible preferred stock into Common Stock | ||||||||
Stock-based compensation expense | 96 | 96 | ||||||
Other comprehensive gain/(loss) | (2) | (2) | ||||||
Net loss | (1,536) | (1,536) | ||||||
Balance (in shares) at Sep. 30, 2019 | 21,660 | 19,585,394 | ||||||
Balance at Sep. 30, 2019 | $ 21,183 | $ 19 | $ 210,683 | $ (223,852) | $ 2 | $ 8,035 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Operating activities | ||
Net loss | $ (13,382,000) | $ (15,470,000) |
Reconciliation of net loss to net cash used in operating activities: | ||
Depreciation | 279,000 | 83,000 |
Amortization of discount on available-for-sale securities | (4,000) | (35,000) |
Foreign currency remeasurement loss | (3,000) | (25,000) |
Stock-based compensation | 977,000 | 2,647,000 |
Changes in: | ||
Prepaid expenses and other assets | 1,082,000 | 589,000 |
Operating lease right-of-use asset | 200,000 | |
Interest receivable | 10,000 | (3,000) |
Accounts payable and accrued expenses | (1,465,000) | (6,706,000) |
Operating lease liability | (200,000) | |
Net cash used in operating activities | (12,506,000) | (18,920,000) |
Investing activities | ||
Purchases of available-for-sale investments | (12,951,000) | |
Proceeds from maturities of available-for-sale investments | 2,500,000 | 23,990,000 |
Proceeds from sale of available-for-sale investments | 1,999,000 | |
Purchase of property and equipment | (16,000) | (24,000) |
Net cash provided by investing activities | 2,484,000 | 13,014,000 |
Financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 2,853,000 | |
Proceeds from issuance of common stock under ESPP | 84,000 | |
Net cash provided by financing activities | 2,937,000 | |
Effect of exchange rate changes on cash | 24,000 | |
Decrease in cash, cash equivalents and restricted cash | (10,022,000) | (2,945,000) |
Cash, cash equivalents and restricted cash, beginning of period | 19,393,000 | 21,192,000 |
Cash, cash equivalents and restricted cash, end of period | $ 9,371,000 | $ 18,247,000 |
Note 1 - Organization and Ope_3
Note 1 - Organization and Operations | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes to Financial Statements | ||
Nature of Operations [Text Block] | 1. Organization and Operations Proteon Therapeutics, Inc. (the "Company") is a biopharmaceutical company that has historically focused on the development of novel, first-in-class pharmaceuticals to address the medical needs of patients with kidney and vascular disease. The Company was formed in June 2001 and incorporated on March 24, 2006. On March 28, 2019, the Company announced that its second Phase 3 trial, PATENCY-2, for vonapanitase did not meet its co-primary endpoints of fistula use for hemodialysis (p=0.328) and secondary patency (p=0.932). The PATENCY-2 clinical trial was the second of two randomized, double-blind Phase 3 trials, comparing a 30 microgram dose of investigational vonapanitase to placebo in patients with chronic kidney disease, or CKD, undergoing creation of a radiocephalic fistula for hemodialysis. Following the release of top-line data from the PATENCY-2 clinical trial of vonapanitase on March 28, 2019, the Company began to evaluate its strategic alternatives focusing on enhancing stockholder value. It is conducting the process with the assistance of financial and legal advisors and is evaluating the full range of potential strategic alternatives, including but not limited to, a merger or sale of the Company, including a sale of assets or intellectual property, business combinations, joint ventures, public and private capital raises and recapitalization options. As part of these efforts, on April 15, 2019, the Company announced the engagement of H.C. Wainwright & Co., LLC as its financial advisor to assist in the strategic review process. Since these efforts may not be successful, the Company is also considering other possible alternatives, including a wind-down of operations and a liquidation and dissolution of the Company. On September 23, 2019, the Company entered into a merger agreement with ArTara Therapeutics, Inc. ("ArTara"). The Company has discontinued substantially all its research and development activities, including a reduction in workforce, to reduce operating expenses while it evaluates these opportunities. As of September 30, 2019, the Company has terminated all but one of its employees. The Company has recorded severance costs of $2.9 million, all of which was recorded in the three months ended June 30, 2019. These severance related expenses were fully recorded in the three months ending June 30, 2019. The Company remains subject to a number of risks similar to other companies in the biotechnology industry, including compliance with government regulations, protection of proprietary technology, dependence on third parties and product liability. As of September 30, 2019, the Company had cash and cash equivalents of $9.3 million. The Company believes that its existing cash and cash equivalents will be sufficient to fund its projected cash needs into 2020 and enable it to complete the proposed merger with ArTara, pursuant to which REM 1 Acquisition 1, Inc. (the "Merger Sub"), a wholly owned subsidiary of the Company, will be merged with and into ArTara, with ArTara surviving as a wholly owned subsidiary of the Company (the "Merger"). However, if there is a delay in completing the Merger, the Company will require additional capital to sustain its operations through such completion or the Company will need to pursue an immediate dissolution. If the Company needs additional capital, it would need to raise such capital through debt or equity financings, asset sales or other strategic transactions. However, there can be no assurances that the Company will be able to complete any such transaction on acceptable terms or otherwise. The failure to obtain sufficient funds on commercially acceptable terms when needed could have a material adverse effect on the Company's business, results of operations and financial condition and may prevent it from completing the Merger. Accordingly, these factors, among others, raise substantial doubt about the Company's ability to continue as a going concern. The Company had an accumulated deficit of $223.9 million as of September 30, 2019. The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to its administrative organization. Additionally, as stated above, the Company announced that its second Phase 3 trial, PATENCY-2, for vonapanitase did not meet its co-primary endpoints. As a result, the Company has discontinued substantially all its research and development activities to reduce operating expenses while it evaluates its strategic alternatives, including the Merger. These conditions raise substantial doubt about its ability to continue as a going concern within one year after the date that the financial statements are issued. To alleviate the conditions that raise substantial doubt about the Company's ability to continue as a going concern, management has implemented a reduction in expenditures plan and as referenced above is pursuing a merger. While the current reduction in spending expenditure plans will allow the Company to fund its operations in the near-term, there can be no assurance that the Company will be able to achieve its future strategic alternatives raising substantial doubt about its ability to continue as a going concern. Pursuant to the requirements of Accounting Standards Codification (ASC) 205-40, Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a going concern within one year after the date that the financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management's plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company's ability to continue as a going concern. The mitigating effect of management's plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity's ability to continue as a going concern within one year after the date that the financial statements are issued. Under ASC 2015-40, the strategic alternatives being pursued by the Company, including the Merger, cannot be considered probable at this time because none of the Company's current plans have been finalized at the time of filing this Quarterly Report on Form 10-Q and the implementation of any such plan is not probable of being effectively implemented as none of the plans are entirely within the Company's control. Accordingly, substantial doubt is deemed to exist about the Company's ability to continue as a going concern within one year after the date these financial statements are issued. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. On September 23, 2019, the Company entered into a merger agreement (the "Merger Agreement") with ArTara. Pursuant to the Merger Agreement, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, the Merger Sub, a wholly owned subsidiary of the Company, will merge with and into ArTara, with ArTara surviving as a wholly owned subsidiary of the Company. Subject to the terms and conditions of the Merger Agreement, at the effective time of the Merger (the "Effective Time"), each share of ArTara common stock outstanding immediately prior to the Effective Time (excluding certain shares to be canceled pursuant to the Merger Agreement and shares held by stockholders who have exercised and perfected appraisal rights will be converted into the right to receive a number of shares of the Company's common stock equal to the exchange ratio, as more fully described below. The Merger is intended to qualify for U.S. federal income tax purposes as a reorganization under the provisions of Section 368(a) of the Internal Revenue Code of 1986, as amended. As promptly as practicable after the date of the Merger Agreement (but in no event later than 50 days following the date of the Merger Agreement), the parties will prepare and the Company will file with the U.S. Securities and Exchange Commission ("SEC") a Registration Statement on Form S-4 (the "Registration Statement") to register the shares of the Company's common stock to be issued at the Effective Time under the Securities Act, and the Company will seek the approval of its stockholders with respect to certain actions, including the following (collectively, the "Company Stockholder Matters"): • the issuance of shares of the Company's common stock to ArTara's stockholders in connection with the transactions contemplated by the Merger Agreement and shares of the Company's capital stock to the institutional investors in the Private Placement, pursuant to The Nasdaq Stock Market LLC ("Nasdaq") rules; • the amendment of the Company's certificate of incorporation (i) to effect immediately prior to the closing of the Merger a reverse split of all outstanding shares of the Company's common stock at a reverse stock split ratio of one new share for every 30 to 50 (or any number in between) shares outstanding (the "Reverse Split") and (ii) to effect immediately after the consummation of the Private Placement the automatic conversion of all outstanding shares of Series A Convertible Preferred Stock (the "Series A Preferred Stock") of the Company into shares of the Company's common stock, without given effect to any existing provision that limits the conversion rights of the Series A Preferred Stock (including, without limitation, the 9.985% beneficial ownership cap) (the "Series A Preferred Automatic Conversion"); and • an amendment to the Company's Amended and Restated 2014 Equity Incentive Plan (the "Plan") to increase the shares available for issuance thereunder by such additional number of shares of the Company's common stock such that the total number of shares of the Company's common stock reserved for issuance under the Plan, after giving effect to such additional shares, would not exceed 15.2% of the shares of the Company's common stock outstanding immediately after the Effective Time, after giving effect to the Reverse Split, the Private Placement and the Series A Preferred Automatic Conversion, as determined by or on behalf of ArTara prior to the effectiveness of the Registration Statement (the "EIP Amendment"). The consummation of the Merger is also subject to the satisfaction or waiver of certain conditions, including, among other things, (i) approval by the Company's stockholders and ArTara's stockholders (other than with respect to the EIP Amendment), (ii) Nasdaq approval of the listing of the shares to be issued to ArTara equity holders in connection with the consummation of the Merger, (iii) satisfaction of all conditions precedent to the closing of the Private Placement (other than the consummation of the Merger and appointment of certain board members), (iv) absence of a material adverse effect since the date of the Merger Agreement, (v) the accuracy of the representations and warranties, subject to material adverse effect qualifications, (vi) compliance by the parties with their respective covenants in all material respects, (vii) the Subscription Agreement (as defined below) being in full force and effect and no less than $40.0 million to be committed thereunder and (viii) the Company having at least $0 in net cash as of the closing date of the Merger (the "Company Net Cash condition"). The Merger Agreement contains certain termination rights for both the Company and ArTara, and further provides that, upon termination of the Merger Agreement under specified circumstances, the Company may be required to pay to ArTara a termination fee of $0.8 million or ArTara may be required to pay to the Company a termination fee of $0.8 million, and in other circumstances each party may be required to reimburse the other party's expenses incurred, up to a maximum of $0.4 million. In accordance with the terms of the Merger Agreement, (i) certain executive officers, directors and stockholders of ArTara (solely in their respective capacities as ArTara stockholders) have entered into support agreements with ArTara and the Company to vote all of their shares of ArTara capital stock in favor of adoption of the Merger Agreement and (ii) certain of the Company's executive officers, directors and stockholders (solely in their respective capacities as the Company's stockholders) have entered into support agreements with ArTara and the Company to vote all of their shares of the its common stock in favor of the Company's Stockholder Matters. Concurrently with the execution of the Merger Agreement, the Company's director and ArTara's directors and officers have entered into lock-up agreements pursuant to which they accepted certain restrictions on transfer of shares of its common stock for the 180-day period following the closing of the Merger. At the Effective Time, the Company will effect a name change and it is anticipated that trading for the Company's securities will be listed on The Nasdaq Capital Market. Additionally, at the Effective Time, the Company's board of directors is expected to consist of seven members, with five such members designated by ArTara, one such member designated by the Company, and one such member who will be Jesse Shefferman, the President and Chief Executive Officer of the combined company. In connection with the Merger, on September 23, 2019, the company has entered into a Subscription Agreement (the "Subscription Agreement") with certain institutional investors (the "Investors"), pursuant to which the Company has agreed to issue in a private placement (the "Private Placement") (i) up to 27,200 shares of the Company's Series 1 Convertible Non-Voting Preferred Stock, par value $0.001 per share (the "Series 1 Preferred Stock"), at a purchase price equal to 1,000 times the Common Stock Purchase Price (as defined below) and (ii) up to 15,300 shares of the Company's common stock (together with the Series 1 Preferred Stock, the "Private Placement Shares"), at a purchase price equal to (x) the Aggregate Valuation (as defined in the Merger Agreement) divided by the (y) the Post-Closing Parent Shares (as defined in the Merger Agreement) (the "Common Stock Purchase Price"). Pursuant to the Subscription Agreement, certain holders of Series 1 Preferred Stock have preemptive rights to participate pro rata in the Company's future equity financings, subject to certain exceptions and limitations. In addition, following the issuance of the Private Placement Shares pursuant to the Subscription Agreement, the lead investor has the right (but not the obligation) to appoint up to two directors to the combined company's board and one other investor has the right (but not the obligation) to appoint one director to the combined company's board, in each case subject to requirements related to holding minimum amounts of the combined company's equity securities. In addition, at any time when it does not have a designee serving on the board, each of these investors has a right to designate an individual to be present and participate in a non-voting capacity in all meetings of the combined company's board and board committees. As of the date hereof, neither investor has notified the Company of an imminent intention to appoint such directors or non-voting observers. Further, the Company has also agreed not to take certain actions related to the business without the consent of the lead investor for so long as such lead investor continues to hold a minimum amount of the Private Placement Shares purchased under the Subscription Agreement. These actions include (a) liquidating, dissolving or winding-up the affairs of the company; (b) any merger, consolidation or other Fundamental Transaction (defined in the Subscription Agreement); (c) amendments to the combined company's certificate of incorporation or bylaws in a manner that adversely effects the Series 1 Preferred Stock and that is disproportionate to the effect on any other class or series of capital stock; (d) material changes to the principal business of the combined company; (e) purchases, redemptions or the payment of dividends on any capital stock (subject to certain exceptions); (f) the sale, assignment, license or pledge of TARA-002; and (g) transactions involving assets of the combined company with an aggregate value over a defined threshold. Prior to the issuance of the Private Placement Shares, the Company intends to file a Certificate of Designation of Preferences, Rights and Limitations of Series 1 Convertible Non-Voting Preferred Stock (the "Certificate of Designation") with the Delaware Secretary of State. Thereunder, each share of non-voting Series 1 Preferred Stock will be convertible into 1,000 shares of the Company's common stock, at a conversion price initially equal to the Common Stock Purchase Price, subject to adjustment for any stock splits, stock dividends and similar events, at any time at the option of the holder, provided that any conversion of Series 1 Preferred Stock by a holder into shares of the Company's common stock would be prohibited if, as a result of such conversion, the holder, together with its affiliates and any other person or entity whose beneficial ownership of the common stock would be aggregated with such holder's for purposes of Section 13(d) of the Exchange Act would beneficially own more than 9.99% of the total number of shares of the Company's common stock issued and outstanding after giving effect to such conversion. Upon written notice to the Company, the holder may from time to time increase or decrease such limitation to any other percentage not in excess of 19.99% specified in such notice. If the investors purchasing Series 1 Preferred Stock in the Private Placement each elect to increase such limitation to 19.99% and each investors elects to convert the maximum number of shares of Series 1 Preferred Stock into shares of voting common stock as would then be permitted, the investors in the Private Placement, together with the ArTara Private Placement, would own a majority of the outstanding shares of common stock, calculated as of immediately following the effectiveness of the Merger and Private Placements. As a result, these stockholders, acting together, could have substantial influence over most matters that require approval by the combined company's stockholders, including the election of directors, any merger, consolidation or sale of all or substantially all or of the combined company's assets or any other significant corporate transaction. However, Proteon has no reason to believe that these stockholders intend to convert their non-voting shares of Series 1 Preferred Stock to common stock or act together on any matters in the future. Each share of Series 1 Preferred Stock will be entitled to a preference of $10.00 per share upon the Company's liquidation, and thereafter will share ratably in any distributions or payments on an as-converted basis with the holders of the Company's common stock. In addition, upon the occurrence of certain transactions that involve the Company's merger or consolidation, an exchange or tender offer, a sale of all or substantially all of the Company's assets or a reclassification of the Company's common stock, each share of Series 1 Preferred Stock will be convertible into the kind and amount of securities, cash and/or other property that the holder of a number of shares of the Company's common stock issuable upon conversion of one share of Series 1 Preferred Stock would receive in connection with such transaction. The Private Placement is expected to close immediately following the consummation of the Merger. | 1. Organization and Operations The Company Proteon Therapeutics, Inc. (the “Company”) is a late-stage biopharmaceutical company focused on the development of novel, first June 2001 March 24, 2006. The Company devotes substantially all of its efforts to product research and development, initial market development and raising capital. The Company has not third Liquidity and Going Concern As of December 31, 2018, $21.9 first 2020. $210.5 December 31, 2018. Based on these available cash resources, the Company does not twelve 10 The Company’s plans to address this condition include pursuing one none • raise additional funding through the possible sale of additional shares of the Company’s common stock, including public or private equity financings, and/or possible debt financings; and • use the worldwide commercial rights to vonapanitase currently held by the Company to establish partnerships for the development and commercialization of vonapanitase in all or parts of Europe and other countries outside of the United States to secure additional funding. There can be no twelve 10 Pursuant to the requirements of Accounting Standards Codification (ASC) 205 40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern one not not 1 one 2 one Under ASC 2015 40, none 10 not none one The Company believes that its approximate $21.9 December 31, 2018, first 2020. no no no 2019 If the Company is unable to obtain sufficient capital to continue to advance its programs, the Company would be forced to delay, reduce or eliminate its ongoing development and other activities. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not At-The-Market Equity Offering Program On November 12, 2015, 3 $40 January 12, 2016. 3% March 16, 2017 I.B.6 3, may February 7, 2019, 3, No. 333 228865, December 31, 2017, 896,811 $1.4 $0.1 December 31, 2018, 1,494,579 $3.0 December 31, 2018, $46,000, 1,494,579 December 31, 2018 September 25, 2018 Series A Preferred Financing On June 22, 2017, 22,000 $0.001 $1,000 $22.0 August 2, 2017 ( 7 On August 2, 2017, August 3, 2017, 3 August 21, 2017. |
Note 2 - Summary of Significa_5
Note 2 - Summary of Significant Accounting Policies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes to Financial Statements | ||
Significant Accounting Policies [Text Block] | 2. Summary of Significant Accounting Policies Basis of Presentation, Principles of Consolidation and Use of Estimates The unaudited interim condensed consolidated financial statements of the Company included herein have been prepared, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the financial statements as of and for the year ended December 31, 2018 10 March 13, 2019. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements. In the opinion of the Company’s management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments which are necessary to fairly present the Company’s financial position as of September 30, 2019, three nine September 30, 2019 2018, nine September 30, 2019 2018, nine September 30, 2019 2018. three nine September 30, 2019 not December 31, 2019, The unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. These condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not may Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, available-for-sale investments, accounts payable, and accrued liabilities. The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. FASB ASC Topic 820, Fair Value Measurement and Disclosures not one three Level 1—Valuations Level 2—Valuations not Level 3—Valuations To the extent that 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 in Level 3. Financial instruments measured at fair value on a recurring basis include cash equivalents and available-for-sale investments. There have been no three nine September 30, 2019 2018. no three nine September 30, 2019 2018. Net Income (Loss) per Share Attributable to Common Stockholders Basic net income (loss) per share is calculated by dividing net income (loss) attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net income per share is calculated by dividing the net income attributable to common stockholders by the weighted-average number of common equivalent shares outstanding for the period, including any dilutive effect from outstanding stock options and warrants using the treasury stock method. The Company follows the two two two not Recent Accounting Pronouncements In May 2014, 2014 09, 2014 09” January 1, 2018, 2017 09 March 31, 2018. not In February 2016, 2016 02, 842 2016 02” 2016 01 January 1, 2019 not 842, 842. 842 842, not As a result of the adoption of ASU 2016 02, January 1, 2019, $0.2 8%, $0.2 no January 1, 2019. not 2016 02. In August 2016, 2016 15, 230 2016 15” eight December 15, 2017, first 2018 2016 15 March 31, 2018. not In November 2016, 2016 18, December 15, 2017, first 2018. 2016 18 March 31, 2018. $22,000 $22,000 nine September 30, 2019 2018. In May 2017, No. 2017 09, 718 2017 09” 2017 09, not 2017 09 December 15, 2017. 2017 09 March 31, 2018. not In June 2018, No. 2018 07, 718 2018 07” 2018 07 2018 07 December 15, 2018. January 1, 2019. 2018 07 March 31, 2019. not March 31, 2018. | 2. Summary of Significant Accounting Policies Basis of Presentation, Principles of Consolidation and Use of Estimates The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. These consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not may Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company and the Company's chief operating decision maker view the Company's operations and manage its business in one one Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, available-for-sale investments, forward foreign currency contracts (see Note 3 820, Fair Value Measurement and Disclosures not one three Level 1—Valuations Level 2—Valuations not Level 3—Valuations To the extent that 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 in Level 3. Financial instruments measured at fair value on a recurring basis include cash equivalents, available-for-sale investments and forward foreign currency contracts (see Note 3 no December 31, 2018 2017. no December 31, 2018 2017. Recent Accounting Pronouncements In May 2014, 2014 09, Revenue from Contracts with Customers 2014 09” January 1, 2018, 2017 09 March 31, 2018. not In February 2016, 2016 02, 842 2016 02” January 1, 2019 not In August 2016, 2016 15, Statement of Cash Flows (Topic 230 2016 15” eight December 15, 2017, first 2018 2016 15 March 31, 2018. not In November 2016, 2016 18, Statement of Cash Flows, Restricted Cash December 15, 2017, first 2018. 2016 18 March 31, 2018. $22,000 $14,000 December 31, 2018 2017, $22,000 December 31, 2018 2017. In May 2017, No. 2017 09, Compensation - Stock Compensation (Topic 718 2017 09” 2017 09, not 2017 09 December 15, 2017. 2017 09 March 31, 2018. not In June 2018, No. 2018 07, 718 2018 07” 2018 07 2018 07 December 15, 2018. January 1, 2019. Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of 90 Short-Term Investments The Company classifies its investments as available-for-sale and records such assets at estimated fair value in the consolidated balance sheets, with unrealized gains and losses, if any, reported as a component of other comprehensive income (loss) within the consolidated statements of operations and comprehensive loss and as a separate component of stockholders' equity (deficit). The Company invests its excess cash balances primarily in government debt securities and money market funds with strong credit ratings and maturities of less than one no December 31, 2018, 2017 2016. At each balance sheet date, the Company assesses available-for-sale securities in an unrealized loss position to determine whether the unrealized loss is other-than-temporary. The Company considers factors including: the significance of the decline in value compared to the cost basis, underlying factors contributing to a decline in the prices of securities in a single asset class, the length of time the market value of the security has been less than its cost basis, the security's relative performance versus its peers, sector or asset class, expected market volatility and the market and economy in general. When the Company determines that a decline in the fair value below its cost basis is other-than-temporary, the Company recognizes an impairment loss in the year in which the other-than-temporary decline occurred. There have been no December 31, 2018, 2017 2016, not Concentrations of Credit Risk and Off-Balance Sheet Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents and short-term investments. The Company's cash and cash equivalents are held in accounts with financial institutions that management believes are creditworthy. The Company's investment policy includes guidelines on the quality of the institutions and financial instruments and defines allowable investments that the Company believes minimizes the exposure to concentration of credit risk. These amounts at times may not not no Property and Equipment Property and equipment is stated at cost, less accumulated depreciation. Maintenance and repairs that do not not, Asset Estimated Useful Life (in years) Computer equipment and software 3 Furniture, fixtures and other 5 Laboratory equipment 7 Research and Development Costs Research and development costs are charged to expense as incurred in performing research and development activities. The costs include employee compensation costs, facilities and overhead, clinical study and related clinical manufacturing costs, regulatory and other related costs. Nonrefundable advanced payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. Stock-Based Compensation Expense The Company accounts for its stock-based compensation awards to employees and directors in accordance with FASB ASC Topic 718, Compensation-Stock Compensation 718” 718 718 505, Equity The Company estimates the fair value of its stock options using the Black-Scholes option pricing model, which requires the input of subjective assumptions, including (a) the expected stock price volatility, (b) the expected term of the award, (c) the risk-free interest rate, (d) expected dividends and (e) the estimated fair value of its Common Stock on the measurement date. Due to the lack of company specific historical and implied volatility data of its Common Stock, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. When selecting these public companies on which it has based its expected stock price volatility, the Company selected companies with comparable characteristics to it, including enterprise value, risk profiles, position within the industry and with historical share price information sufficient to meet the expected term of the stock based awards. The Company computes historical volatility data using the daily closing prices for the selected companies' shares during the equivalent period of the calculated expected term of the stock-based awards. During 2018 not 2, Use of Estimates Income Taxes Income taxes are recorded in accordance with FASB ASC Topic 740, 740” not not may not The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. not not December 31, 2018 2017, not 10 Net Income (Loss) per Share Attributable to Common Stockholders Basic net income (loss) per share is calculated by dividing net income (loss) attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net income per share is calculated by dividing the net income attributable to common stockholders by the weighted-average number of common equivalent shares outstanding for the period, including any dilutive effect from outstanding stock options and warrants using the treasury stock method. The Company follows the two two two not Comprehensive Loss Comprehensive loss consists of net income or loss and changes in equity during a period from transactions and other events and circumstances generated from non-owner sources. The Company's net loss equals comprehensive loss, net of any changes in the unrealized gains and losses of the Company's short-term investments, held as available-for-sale, and foreign currency translation for all periods presented. Subsequent Events The Company considers events or transactions that occur after the balance sheet date but prior to the date the consolidated financial statements are available to be issued for potential recognition or disclosure in the financial statements. The Company has completed an evaluation of all subsequent events after the consolidated balance sheet date of December 31, 2018 December 31, 2018 not |
Note 3 - Fair Value Measureme_5
Note 3 - Fair Value Measurements | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes to Financial Statements | ||
Fair Value Disclosures [Text Block] | 3. Fair Value Measurements Below is a summary of assets and liabilities measured at fair value (in thousands): As of September 30, 2019 Quoted Prices Significant Significant Total Assets Cash equivalents $ 9,101 $ - $ - $ 9,101 Total $ 9,101 $ - $ - $ 9,101 As of December 31, 2018 Quoted Prices Significant Significant Total Assets Cash equivalents $ 18,353 $ - $ - $ 18,353 Government securities 2,496 - - 2,496 Total $ 20,849 $ - $ - $ 20,849 As of September 30, 2019 December 31, 2018, 90 Available-for-sale securities at September 30, 2019 December 31, 2018 Amortized Cost Unrealized Gains Unrealized Losses Fair Value September 30, 2019 Government securities (Due within 1 year) $ - $ - $ - $ - $ - $ - $ - $ - December 31, 2018 Government securities (Due within 1 year) $ 2,496 $ - $ - $ 2,496 $ 2,496 $ - $ - $ 2,496 | 3. Fair Value Measurements Below is a summary of assets and liabilities measured at fair value (in thousands): As of December 31, 2018 Quoted Prices Significant Significant in Active Observable Unobservable Markets Inputs Inputs (Level 1) (Level 2) (Level 3) Total Assets Cash equivalents $ 18,353 $ - $ - $ 18,353 Government securities 2,496 - - 2,496 Total $ 20,849 $ - $ - $ 20,849 As of December 31, 2017 Quoted Prices Significant Significant in Active Observable Unobservable Markets Inputs Inputs (Level 1) (Level 2) (Level 3) Total Assets Cash equivalents $ 11,662 $ - $ - $ 11,662 Government securities 20,971 - - 20,971 Total $ 32,633 $ - $ - $ 32,633 As of December 31, 2018, 2017, 90 Available-for-sale securities at December 31, 2018 2017 Amortized Cost Unrealized Gains Unrealized Losses Fair Value December 31, 2018 Government securities (Due within 1 year) $ 2,496 $ - $ - $ 2,496 $ 2,496 $ - $ - $ 2,496 December 31, 2017 Government securities (Due within 1 year) $ 20,991 $ - $ (20 ) $ 20,971 $ 20,991 $ - $ (20 ) $ 20,971 |
Note 4 - Property and Equipme_5
Note 4 - Property and Equipment, Net | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes to Financial Statements | ||
Property, Plant and Equipment Disclosure [Text Block] | 4. Property and Equipment, net Property and equipment, net consists of the following (in thousands): As of September 30, 2019 December 31, 2018 Computer equipment and software $ - $ 211 Furniture, fixtures, and other - 365 Laboratory equipment - 514 - 1,090 Accumulated depreciation - (827 ) Property and equipment, net $ - $ 263 Depreciation expense for the three nine September 30, 2019 $0.1 $0.3 three nine September 30, 2018 $22,000, $0.1 During the three March 31, 2019, March 31, 2019 March 31, 2019. September 30, 2019, no zero $0.2 three nine September 30, 2019. September 30, 2019, no | 4. Property and Equipment, net Property and equipment, net consists of the following (in thousands): As of December 31, 2018 2017 Computer equipment and software $ 211 $ 192 Furniture, fixtures, and other 365 302 Laboratory equipment 514 477 1,090 971 Accumulated depreciation (827 ) (712 ) Property and equipment, net $ 263 $ 259 Depreciation expense for the years ended December 31, 2018, 2017 2016 $0.1 $0.1 $0.1 |
Note 5 - Commitments and Contin
Note 5 - Commitments and Contingencies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes to Financial Statements | ||
Commitments and Contingencies Disclosure [Text Block] | 5. Commitments and Contingencies Operating Lease The Company’s facility is located in Waltham, Massachusetts. In July 2018, September 2019. three nine September 30, 2019, $0.1 $0.2 September 30, 2019, not September 30, 2019, no September 30, 2019, $22,000 30 September 30, 2019. Restricted cash related to facilities leases As of September 30, 2019 December 31, 2018, $22,000 September 30, 2019 December 31, 2018, $22,000 30 September 30, 2019. | 6. Commitments and Contingencies Significant Contracts and Agreements In February 2002, 2.5% December 31, 2018 not no Operating Leases The Company has various non-cancellable operating leases for facilities and office equipment that expire at various dates through 2019. August 2017, July 13, 2009 ( fifteen 15 June 30, 2018 September 30, 2019 2,552 7,500 200 one six $0.3 $0.2 $0.2 December 31, 2018, 2017 2016, Future minimum payments required under operating leases as of December 31, 2018 Year Ending December 31: Amount 2019 207 Total minimum lease payments $ 207 In addition to the base rent, the Company is also responsible for its share of operating expenses and real estate taxes, in accordance with the terms of the lease agreement. As of December 31, 2018, $22,000 Restricted cash related to facilities leases At December 31, 2018 2017, $22,000 December 31, 2018 2017, $22,000 |
Note 6 - Stock-based Compensati
Note 6 - Stock-based Compensation | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes to Financial Statements | ||
Share-based Payment Arrangement [Text Block] | 6. Stock-based Compensation Stock Options The following table summarizes stock option activity for employees: Options Weighted- Weighted- Aggregate Outstanding at December 31, 2018 4,597,226 $ 5.12 7.4 $ 404 Granted 1,182,500 $ 2.66 Exercised - Forfeited (1) (2,606,289 ) $ 2.79 Expired (1) (2,400,590 ) $ 6.51 Outstanding at September 30, 2019 772,847 $ 4.89 7.3 $ - Exercisable at September 30, 2019 476,390 $ 6.13 6.4 $ - Vested or expected to vest at September 30, 2019 (2) 772,847 $ 4.89 7.3 $ - _____________________ ( 1 nine September 30, 2019 ( 2 September 30, 2019 September 30, 2019. Employee Stock Purchase Plan The 2014 140,500 January 1, January 1, 2015 January 1, 2024, one 281,000 January 1st. September 30, 2019, January 1, 2019 one December 31, 2018, 2014 192,436 tenth 2014 July 1, 2019 September 30, 2019. No three nine September 30, 2019. No 51,984 three nine September 30, 2018 2014 zero $68,000 2014 three nine September 30, 2019 $20,000 $0.1 2014 three nine September 30, 2018, Common Stock The Company has the following shares of Common Stock reserved for future issuance: September 30, December 31, 2019 2018 Conversion of Series A Preferred Stock 21,771,032 22,112,775 Stock-based compensation awards 6,818,214 5,163,957 Employee Stock Purchase Plan 118,120 118,120 Total 28,707,366 27,394,852 | 9. Stock-based Compensation On August 21, 2014, 2006 “2006 2014 “2014 2014 “2014 October 3, 2014, 2014 July 31, 2017. The Plans provide for the grant of incentive and non-statutory stock options, stock appreciation rights, restricted stock and stock unit awards, performance units, stock grants and qualified performance-based awards. Under the 2006 no 704,000 2014 2014 2014 January 1, January 1, 2015 four December 31 January 1st. Terms of the stock awards, including vesting requirements, are determined by the Board of Directors, subject to the provisions of the Plans. Options granted by the Company typically vest over three four 2006 ten 2014 Stock-based compensation expense Total stock-based compensation expense is recognized for stock options granted to employees and non-employees and has been reported in the Company’s consolidated statements of operations as follows (in thousands): Year Ended December 31, 2018 2017 2016 Research and development $ 1,142 $ 1,109 $ 1,114 General and administrative 2,287 2,118 2,229 Total $ 3,429 $ 3,227 $ 3,343 The Company estimates the fair value of each employee stock award on the grant date using the Black-Scholes option-pricing model based on the following assumptions regarding the fair value of the underlying Common Stock on each measurement date: Year Ended December 31, 2018 2017 2016 Weighted average expected volatility 93.5 % 94.5 % 84.4 % Expected term (in years) 6.07 6.06 6.05 Risk free interest rate 2.55 % 2.09 % 1.45 % Expected dividend yield 0 % 0 % 0 % Stock options issued to non-employees are accounted for using the fair value method of accounting; they are periodically revalued as the options vest and are recognized as expense over the related service period. The total expense related to all options granted to non-employees was $0 December 31, 2018, 2017 2016. Stock Options The following table summarizes stock option activity for employees and non-employees: Options Weighted- Weighted- Aggregate Outstanding at December 31, 2017 2,681,072 $ 7.18 6.8 $ 121 Granted 2,041,600 $ 2.61 Exercised - Forfeited (83,433 ) $ 5.82 Expired (42,013 ) $ 13.30 Outstanding at December 31, 2018 4,597,226 $ 5.12 7.4 $ 404 Exercisable at December 31, 2018 2,067,356 $ 7.57 5.7 $ 241 Vested or expected to vest at December 31, 2018 (1) 4,597,226 $ 5.12 7.4 $ 404 __________________ ( 1 December 31, 2018 December 31, 2018. During the year ended December 31, 2018, 2,041,600 $2.61. December 31, 2017, 719,337 $1.99. December 31, 2016, 132,495 $7.11 $5.08. The total intrinsic value of options exercised in the years ended December 31, 2018 2017 $0 $27,000 December 31, 2018, 2017 $4.6 $4.2 2.40 Employee Stock Purchase Plan The 2014 140,500 January 1, January 1, 2015 January 1, 2024, one 281,000 January 1st. no January 1, 2018. December 31, 2018, 2014 304,991 seventh 2014 January 1, 2018 June 30, 2018 eight July 1, 2018 December 31, 2018. December 31, 2018 2017, 74,343 100,358 2014 $0.1 2014 December 31, 2018, 2017, 2016. |
Note 7 - Income Taxes
Note 7 - Income Taxes | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes to Financial Statements | ||
Income Tax Disclosure [Text Block] | 7. Income Taxes Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes. The Company has evaluated the positive and negative evidence bearing upon the Company’s ability to realize the benefit of its deferred tax assets. Based on the Company’s history of operating losses, the Company has concluded that it is more likely than not not no nine September 30, 2019 2018. | 10. Income Taxes The components of loss from operations before income taxes are as follows (in thousands): Year Ended December 31, 2018 2017 2016 Domestic $ (17,855 ) $ (24,803 ) $ (15,860 ) Foreign (2,874 ) (5,161 ) (12,666 ) Total $ (20,729 ) $ (29,964 ) $ (28,526 ) For the years ended December 31, 2018, 2017, 2016, not A reconciliation of income taxes computed using the U.S. federal statutory rate to that reflected in operations is as follows (in thousands): Year Ended December 31, 2018 2017 2016 Income tax benefit computed at federal statutory tax rate $ (4,348 ) $ (10,186 ) $ (9,696 ) Permanent differences 6 4 430 Stock compensation - permanent items 325 689 - R&D credit - permanent items - 1,751 1,437 State income taxes, net of federal benefit (958 ) (853 ) (498 ) Tax credits (1,466 ) (5,495 ) (4,846 ) Change in valuation allowance 5,409 (54,319 ) 8,804 Foreign rate differential 602 1,752 4,304 Rate change - 2,202 - 382 limitation - 64,975 - Other 430 (520 ) 65 Total $ - $ - $ - The significant components of the Company's deferred tax assets are as follows (in thousands): Year Ended December 31, 2018 2017 2016 Deferred tax assets: Net operating loss carryforwards $ 6,742 $ 2,651 $ 37,237 Federal and state tax credits 3,122 2,244 21,223 Accrued expenses 411 399 544 Patents 132 191 360 Stock-based compensation 1,782 1,262 1,353 Other 169 202 321 Total deferred tax assets 12,358 6,949 61,038 Valuation allowance (12,358 ) (6,949 ) (61,038 ) Net deferred assets $ - $ - $ - Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. Based on the Company's history of operating losses, management of the Company has concluded that it is more likely than not not December 31, 2018, 2017, 2016. On December 22, 2017, 34% 21%. $2.2 no not 2017 2018 The Company’s preliminary estimate of the TCJA and the remeasurement of its deferred tax assets and liabilities is subject to the finalization of management’s analysis related to certain matters, such as developing interpretations of the provisions of the TCJA, changes to certain estimates and the filing of our tax returns. U.S. Treasury regulations, administrative interpretations or court decisions interpreting the TJCA may 2017 fourth 2018 no Net operating loss and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service (the "IRS") and may three 50% 382 383 may August 2, 2017, $22.0 §382 §383 August 2, 2017 August 2, 2017 $107.3 $34.1 $23.8 $5.0 $2.1 As a result of current year activity, the valuation allowance increased by approximately $5.4 December 31, 2018. December 31, 2017, $13.1 $65.0 §382 $2.2 $54.1 $8.8 December 31, 2016, Subject to the limitations described below, as of December 31, 2018, 2017, 2016, $25.7 $10.6 $0.0 2018 2037. 2018 December 31, 2018 $14.7 December 31, 2018, 2017, 2016, $21.5 $6.8 $0.0 2037 2038. December 31, 2018, 2017 2016, $3.1 $2.3 $0.0 2037 2038. The Company had no December 31, 2018, 2017, 2016. The Company is subject to U.S. federal income tax and primarily Massachusetts state income tax. The statute of limitations for assessment by the IRS and state tax authorities is open for tax years ending December 31, 2015 2018, 2015 may no |
Note 8 - Net Loss Per Share Att
Note 8 - Net Loss Per Share Attributable to Common Stockholders | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes to Financial Statements | ||
Earnings Per Share [Text Block] | 8. Net Loss per Share Attributable to Common Stockholders As described in Note 2, three nine September 30, 2019 2018 no two The following Common Stock equivalents, presented on an as converted basis, were excluded from the calculation of net loss per share for the periods presented, due to their anti-dilutive effect: Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Outstanding stock options 772,847 4,597,226 772,847 4,597,226 Outstanding ESPP shares - 26,642 - 26,642 Convertible preferred stock 21,771,032 22,112,775 21,771,032 22,112,775 22,543,879 26,736,643 22,543,879 26,736,643 | 11. Net Loss per Share Attributable to Common Stockholders As described in Note 2, December 31, 2018, 2017 2016 no two 2017 not $6.7 not The following Common Stock equivalents, presented on an as converted basis, were excluded from the calculation of net loss per share for the periods presented, due to their anti-dilutive effect: Year Ended December 31, 2018 2017 2016 Outstanding stock options 4,597,226 2,681,072 2,166,254 Convertible preferred stock 22,112,775 22,112,775 - 26,710,001 24,793,847 2,166,254 |
Note 9 - Restructuring Charges
Note 9 - Restructuring Charges | 9 Months Ended |
Sep. 30, 2019 | |
Notes to Financial Statements | |
Restructuring and Related Activities Disclosure [Text Block] | 9. In April 2019, “2019 2 March 28, 2019. December 31, 2019 ( 2019” $2.9 three June 30, 2019. Changes in the restructuring accrual during the first nine September 30, 2019 As of December 31, Charges/(Benefits) Payment/Other As of September 30, 2019 Restructuring Program Employee Severance $ - $ 2,854 $ (1,834 ) $ 1,020 Total $ - $ 2,854 $ (1,834 ) $ 1,020 |
Note 10 - Subsequent Events
Note 10 - Subsequent Events | 9 Months Ended |
Sep. 30, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | 10. Subsequent Events On November 15, 2019, a lawsuit entitled Patrick Plumley v. Proteon Therapeutics, Inc., et al. , Case No. 1:19-cv-02143-UNA, was filed in the United States District Court for the District of Delaware against the Company, ArTara, Merger Sub and the individual members of the Proteon Board. On November 30, 2019, a lawsuit entitled Jeffrey Teow v. Proteon Therapeutics, Inc., et al. , Case No. 1:19-cv-06745, was filed in the United States District Court for the Eastern District of New York against the Company, ArTara, Merger Sub and the individual members of the Proteon Board. On December 2, 2019, a lawsuit entitled Neil Lanteigne v. Proteon Therapeutics, et al. , Case No. 1:19-cv-12436, was filed in the United States District Court for the District of Massachusetts against the Company, ArTara, Merger Sub and the individual members of the Proteon Board. The Plumley complaint is brought as a purported class action lawsuit. All three lawsuits allege that the preliminary registration statement filed by the Company on November 7, 2019 with the SEC in connection with the proposed Merger omits material information with respect to the transactions contemplated by the Merger Agreement, rendering it false and misleading in violation of Sections 14(a) (and Rule 14a-9 promulgated thereunder) and 20(a) of the Exchange Act. The plaintiffs in each of the three lawsuits seek, among other things, injunctive relief, rescission, declaratory relief and unspecified monetary damages. The Company and ArTara intend to defend vigorously against all claims asserted. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | ||
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation, Principles of Consolidation and Use of Estimates The unaudited interim condensed consolidated financial statements of the Company included herein have been prepared, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the financial statements as of and for the year ended December 31, 2018 10 March 13, 2019. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements. In the opinion of the Company’s management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments which are necessary to fairly present the Company’s financial position as of September 30, 2019, three nine September 30, 2019 2018, nine September 30, 2019 2018, nine September 30, 2019 2018. three nine September 30, 2019 not December 31, 2019, The unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. These condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not may | Basis of Presentation, Principles of Consolidation and Use of Estimates The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. These consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not may |
Fair Value Measurement, Policy [Policy Text Block] | Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, available-for-sale investments, accounts payable, and accrued liabilities. The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. FASB ASC Topic 820, Fair Value Measurement and Disclosures not one three Level 1—Valuations Level 2—Valuations not Level 3—Valuations To the extent that 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 in Level 3. Financial instruments measured at fair value on a recurring basis include cash equivalents and available-for-sale investments. There have been no three nine September 30, 2019 2018. no three nine September 30, 2019 2018. | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company and the Company's chief operating decision maker view the Company's operations and manage its business in one one |
Earnings Per Share, Policy [Policy Text Block] | Net Income (Loss) per Share Attributable to Common Stockholders Basic net income (loss) per share is calculated by dividing net income (loss) attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net income per share is calculated by dividing the net income attributable to common stockholders by the weighted-average number of common equivalent shares outstanding for the period, including any dilutive effect from outstanding stock options and warrants using the treasury stock method. The Company follows the two two two not | Net Income (Loss) per Share Attributable to Common Stockholders Basic net income (loss) per share is calculated by dividing net income (loss) attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net income per share is calculated by dividing the net income attributable to common stockholders by the weighted-average number of common equivalent shares outstanding for the period, including any dilutive effect from outstanding stock options and warrants using the treasury stock method. The Company follows the two two two not |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements In May 2014, 2014 09, 2014 09” January 1, 2018, 2017 09 March 31, 2018. not In February 2016, 2016 02, 842 2016 02” 2016 01 January 1, 2019 not 842, 842. 842 842, not As a result of the adoption of ASU 2016 02, January 1, 2019, $0.2 8%, $0.2 no January 1, 2019. not 2016 02. In August 2016, 2016 15, 230 2016 15” eight December 15, 2017, first 2018 2016 15 March 31, 2018. not In November 2016, 2016 18, December 15, 2017, first 2018. 2016 18 March 31, 2018. $22,000 $22,000 nine September 30, 2019 2018. In May 2017, No. 2017 09, 718 2017 09” 2017 09, not 2017 09 December 15, 2017. 2017 09 March 31, 2018. not In June 2018, No. 2018 07, 718 2018 07” 2018 07 2018 07 December 15, 2018. January 1, 2019. 2018 07 March 31, 2019. not March 31, 2018. | Recent Accounting Pronouncements In May 2014, 2014 09, Revenue from Contracts with Customers 2014 09” January 1, 2018, 2017 09 March 31, 2018. not In February 2016, 2016 02, 842 2016 02” January 1, 2019 not In August 2016, 2016 15, Statement of Cash Flows (Topic 230 2016 15” eight December 15, 2017, first 2018 2016 15 March 31, 2018. not In November 2016, 2016 18, Statement of Cash Flows, Restricted Cash December 15, 2017, first 2018. 2016 18 March 31, 2018. $22,000 $14,000 December 31, 2018 2017, $22,000 December 31, 2018 2017. In May 2017, No. 2017 09, Compensation - Stock Compensation (Topic 718 2017 09” 2017 09, not 2017 09 December 15, 2017. 2017 09 March 31, 2018. not In June 2018, No. 2018 07, 718 2018 07” 2018 07 2018 07 December 15, 2018. January 1, 2019. |
Note 3 - Fair Value Measureme_6
Note 3 - Fair Value Measurements (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes Tables | ||
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | As of September 30, 2019 Quoted Prices Significant Significant Total Assets Cash equivalents $ 9,101 $ - $ - $ 9,101 Total $ 9,101 $ - $ - $ 9,101 As of December 31, 2018 Quoted Prices Significant Significant Total Assets Cash equivalents $ 18,353 $ - $ - $ 18,353 Government securities 2,496 - - 2,496 Total $ 20,849 $ - $ - $ 20,849 | As of December 31, 2018 Quoted Prices Significant Significant in Active Observable Unobservable Markets Inputs Inputs (Level 1) (Level 2) (Level 3) Total Assets Cash equivalents $ 18,353 $ - $ - $ 18,353 Government securities 2,496 - - 2,496 Total $ 20,849 $ - $ - $ 20,849 As of December 31, 2017 Quoted Prices Significant Significant in Active Observable Unobservable Markets Inputs Inputs (Level 1) (Level 2) (Level 3) Total Assets Cash equivalents $ 11,662 $ - $ - $ 11,662 Government securities 20,971 - - 20,971 Total $ 32,633 $ - $ - $ 32,633 |
Available-for-sale Securities [Table Text Block] | Amortized Cost Unrealized Gains Unrealized Losses Fair Value September 30, 2019 Government securities (Due within 1 year) $ - $ - $ - $ - $ - $ - $ - $ - December 31, 2018 Government securities (Due within 1 year) $ 2,496 $ - $ - $ 2,496 $ 2,496 $ - $ - $ 2,496 | Amortized Cost Unrealized Gains Unrealized Losses Fair Value December 31, 2018 Government securities (Due within 1 year) $ 2,496 $ - $ - $ 2,496 $ 2,496 $ - $ - $ 2,496 December 31, 2017 Government securities (Due within 1 year) $ 20,991 $ - $ (20 ) $ 20,971 $ 20,991 $ - $ (20 ) $ 20,971 |
Note 4 - Property and Equipme_6
Note 4 - Property and Equipment, Net (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes Tables | ||
Property, Plant and Equipment [Table Text Block] | As of September 30, 2019 December 31, 2018 Computer equipment and software $ - $ 211 Furniture, fixtures, and other - 365 Laboratory equipment - 514 - 1,090 Accumulated depreciation - (827 ) Property and equipment, net $ - $ 263 | As of December 31, 2018 2017 Computer equipment and software $ 211 $ 192 Furniture, fixtures, and other 365 302 Laboratory equipment 514 477 1,090 971 Accumulated depreciation (827 ) (712 ) Property and equipment, net $ 263 $ 259 |
Note 6 - Stock-based Compensa_2
Note 6 - Stock-based Compensation (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes Tables | ||
Share-based Payment Arrangement, Option, Activity [Table Text Block] | Options Weighted- Weighted- Aggregate Outstanding at December 31, 2018 4,597,226 $ 5.12 7.4 $ 404 Granted 1,182,500 $ 2.66 Exercised - Forfeited (1) (2,606,289 ) $ 2.79 Expired (1) (2,400,590 ) $ 6.51 Outstanding at September 30, 2019 772,847 $ 4.89 7.3 $ - Exercisable at September 30, 2019 476,390 $ 6.13 6.4 $ - Vested or expected to vest at September 30, 2019 (2) 772,847 $ 4.89 7.3 $ - | Options Weighted- Weighted- Aggregate Outstanding at December 31, 2017 2,681,072 $ 7.18 6.8 $ 121 Granted 2,041,600 $ 2.61 Exercised - Forfeited (83,433 ) $ 5.82 Expired (42,013 ) $ 13.30 Outstanding at December 31, 2018 4,597,226 $ 5.12 7.4 $ 404 Exercisable at December 31, 2018 2,067,356 $ 7.57 5.7 $ 241 Vested or expected to vest at December 31, 2018 (1) 4,597,226 $ 5.12 7.4 $ 404 |
Common Stock Reserved for Future Issuance [Table Text Block] | September 30, December 31, 2019 2018 Conversion of Series A Preferred Stock 21,771,032 22,112,775 Stock-based compensation awards 6,818,214 5,163,957 Employee Stock Purchase Plan 118,120 118,120 Total 28,707,366 27,394,852 | December 31, December 31, 2018 2017 Conversion of Series A Preferred Stock 22,112,775 22,112,775 Stock-based compensation awards 5,163,957 3,572,457 Employee Stock Purchase Plan 118,120 192,463 Total 27,394,852 25,877,695 |
Note 8 - Net Loss Per Share A_2
Note 8 - Net Loss Per Share Attributable to Common Stockholders (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Notes Tables | ||
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Outstanding stock options 772,847 4,597,226 772,847 4,597,226 Outstanding ESPP shares - 26,642 - 26,642 Convertible preferred stock 21,771,032 22,112,775 21,771,032 22,112,775 22,543,879 26,736,643 22,543,879 26,736,643 | Year Ended December 31, 2018 2017 2016 Outstanding stock options 4,597,226 2,681,072 2,166,254 Convertible preferred stock 22,112,775 22,112,775 - 26,710,001 24,793,847 2,166,254 |
Note 9 - Restructuring Charges
Note 9 - Restructuring Charges (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Notes Tables | |
Schedule of Restructuring Reserve by Type of Cost [Table Text Block] | As of December 31, Charges/(Benefits) Payment/Other As of September 30, 2019 Restructuring Program Employee Severance $ - $ 2,854 $ (1,834 ) $ 1,020 Total $ - $ 2,854 $ (1,834 ) $ 1,020 |
Note 1 - Organization and Ope_4
Note 1 - Organization and Operations (Details Textual) | Sep. 23, 2019USD ($)$ / sharesshares | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($)$ / shares | Dec. 31, 2018USD ($)$ / shares | Dec. 31, 2017USD ($)$ / shares |
Cash, Cash Equivalents, and Short-term Investments, Total | $ 9,300,000 | $ 21,900,000 | |||
Retained Earnings (Accumulated Deficit), Ending Balance | $ (223,852,000) | $ (210,470,000) | $ (189,741,000) | ||
Preferred Stock, Par or Stated Value Per Share | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | ||
Merger Agreement with ArTara [Member] | |||||
Amendment of Certificate of Incorporation, Beneficial Ownership Cap | 9.985% | ||||
Subscription Agreement, Minimum Commitment Amount | $ 40,000,000 | ||||
Merger Consummation Conditions, Net Cash Required | 0 | ||||
Business Combination, Termination Fee That May Be Required of Acquirer | 800,000 | ||||
Business Combination, Termination Fee That May Be Required of Acquiree | 800,000 | ||||
Business Combination, Maximum Reimbursement of the Other Party's Expenses By Either the Acquirer or Acquiree | $ 400,000 | ||||
Period of Lock-out Agreement | 180 days | ||||
Number of Directors Expected Following the Merger | 7 | ||||
Number of Directors Expected Following the Merger, Number Designated By Acquiree | 5 | ||||
Number of Directors Expected Following the Merger, Number Designated By Acquirer | 1 | ||||
Number of Directors Expected Following the Merger, Chief Executive Officer of the Combined Company | 1 | ||||
Merger Agreement with ArTara [Member] | Private Placement [Member] | Common Stock [Member] | |||||
Subscription Agreement, Maximum Number of Shares Agreed to Issue | shares | 15,300 | ||||
Merger Agreement with ArTara [Member] | Private Placement [Member] | Series 1 Convertible Non-voting Preferred Stock [Member] | |||||
Subscription Agreement, Maximum Number of Shares Agreed to Issue | shares | 27,200 | ||||
Preferred Stock, Par or Stated Value Per Share | $ / shares | $ 0.001 | ||||
Subscription Agreement, Purchase Price of Shares Agreed to Issue, Multiple of Common Stock Purchase Price | 1,000 | ||||
Convertible Preferred Stock, Shares Issued upon Conversion | shares | 1,000 | ||||
Preferred Stock, Liquidation Preference Per Share | $ / shares | $ 10 | ||||
Merger Agreement with ArTara [Member] | The 2014 Plan [Member] | |||||
Amendment of Compensation Plan, Increase in Shares Available Under Equity Incentive Plan, Threshold for Common Stock Reserved for Issuance, Percentage | 15.20% | ||||
Merger Agreement with ArTara [Member] | Minimum [Member] | |||||
Amendment of Certificate of Incorporation, Reverse Stock Split to Occur, Ratio | 30 | ||||
Merger Agreement with ArTara [Member] | Minimum [Member] | Private Placement [Member] | Series 1 Convertible Non-voting Preferred Stock [Member] | |||||
Conversion of Preferred Stock, Beneficial Ownership Threshold, Percentage | 9.99% | ||||
Merger Agreement with ArTara [Member] | Maximum [Member] | |||||
Amendment of Certificate of Incorporation, Reverse Stock Split to Occur, Ratio | 50 | ||||
Merger Agreement with ArTara [Member] | Maximum [Member] | Private Placement [Member] | Series 1 Convertible Non-voting Preferred Stock [Member] | |||||
Conversion of Preferred Stock, Beneficial Ownership Threshold, Percentage | 19.99% | ||||
Forecast [Member] | |||||
Severance Costs | $ 2,900,000 |
Note 2 - Summary of Significa_6
Note 2 - Summary of Significant Accounting Policies (Details Textual) - USD ($) | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jan. 01, 2019 | |
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents, Period Increase (Decrease), Including Exchange Rate Effect, Total | $ (10,022,000) | $ (2,945,000) | $ (1,799,000) | $ (15,222,000) | $ (3,639,000) | |
Restricted Cash and Cash Equivalents, Total | 22,000 | 22,000 | 22,000 | 22,000 | ||
Accounting Standards Update 2016-02 [Member] | ||||||
Operating Lease, Liability, Current | $ 200,000 | |||||
Operating Lease, Weighted Average Discount Rate, Percent | 8.00% | |||||
Operating Lease, Right-of-Use Asset | $ 200,000 | |||||
Accounting Standards Update 2016-18 [Member] | ||||||
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents, Period Increase (Decrease), Including Exchange Rate Effect, Total | $ 22,000 | $ 22,000 | $ 22,000 | $ 14,000 |
Note 3 - Fair Value Measureme_7
Note 3 - Fair Value Measurements - Available-for-sale Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Amortized Cost | $ 2,496 | $ 20,991 | |
Unrealized Gains | |||
Unrealized Losses | (20) | ||
Fair Value | 2,496 | 20,971 | |
US Government Agencies Debt Securities [Member] | |||
Amortized Cost | 2,496 | 20,991 | |
Unrealized Gains | |||
Unrealized Losses | (20) | ||
Fair Value | $ 2,496 | $ 20,971 |
Note 3 - Fair Value Measureme_8
Note 3 - Fair Value Measurements - Summary of Assets and Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Total | $ 9,101 | $ 20,849 | $ 32,633 |
Cash Equivalents [Member] | |||
Cash equivalents | 9,101 | 18,353 | 11,662 |
US Government Agencies Debt Securities [Member] | |||
Government securities | 2,496 | 20,971 | |
Fair Value, Inputs, Level 1 [Member] | |||
Total | 9,101 | 20,849 | 32,633 |
Fair Value, Inputs, Level 1 [Member] | Cash Equivalents [Member] | |||
Cash equivalents | 9,101 | 18,353 | 11,662 |
Fair Value, Inputs, Level 1 [Member] | US Government Agencies Debt Securities [Member] | |||
Government securities | 2,496 | 20,971 | |
Fair Value, Inputs, Level 2 [Member] | |||
Total | |||
Fair Value, Inputs, Level 2 [Member] | Cash Equivalents [Member] | |||
Cash equivalents | |||
Fair Value, Inputs, Level 2 [Member] | US Government Agencies Debt Securities [Member] | |||
Government securities | |||
Fair Value, Inputs, Level 3 [Member] | |||
Total | |||
Fair Value, Inputs, Level 3 [Member] | Cash Equivalents [Member] | |||
Cash equivalents | |||
Fair Value, Inputs, Level 3 [Member] | US Government Agencies Debt Securities [Member] | |||
Government securities |
Note 4 - Property and Equipme_7
Note 4 - Property and Equipment, Net (Details Textual) - USD ($) | Jul. 01, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Depreciation, Total | $ 100,000 | $ 22,000 | $ 279,000 | $ 83,000 | $ 115,000 | $ 148,000 | $ 123,000 | |
Property, Plant and Equipment, Net, Ending Balance | $ 0 | 0 | $ 263,000 | $ 259,000 | ||||
Laboratory Equipment [Member] | Research and Development Expense [Member] | ||||||||
Impairment of Long-Lived Assets Held-for-use | $ 0 | $ 200,000 |
Note 4 - Property and Equipme_8
Note 4 - Property and Equipment, Net - Summary of Property and Equipment (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Property and equipment | $ 1,090,000 | $ 971,000 | |
Accumulated depreciation | (827,000) | (712,000) | |
Property and equipment, net | 0 | 263,000 | 259,000 |
Computer Equipment and Software [Member] | |||
Property and equipment | 211,000 | 192,000 | |
Furniture and Fixtures [Member] | |||
Property and equipment | 365,000 | 302,000 | |
Laboratory Equipment [Member] | |||
Property and equipment | $ 514,000 | $ 477,000 |
Note 5 - Commitments and Cont_2
Note 5 - Commitments and Contingencies (Details Textual) a in Thousands | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2019USD ($) | Sep. 30, 2019USD ($) | Oct. 31, 2019a | Jun. 30, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Aug. 31, 2017ft² | |
Operating Lease, Expense | $ 100,000 | $ 200,000 | |||||
Area of Real Estate Property | ft² | 7,500 | ||||||
Security Deposit | $ 22,000 | $ 22,000 | |||||
Letters of Credit Outstanding, Amount | 22,000 | 22,000 | 22,000 | $ 22,000 | |||
Loans Pledged as Collateral | $ 22,000 | $ 22,000 | $ 22,000 | $ 22,000 | |||
Subsequent Event [Member] | |||||||
Area of Real Estate Property | a | 0 |
Note 6 - Stock-based Compensa_3
Note 6 - Stock-based Compensation (Details Textual) - USD ($) | Jan. 01, 2019 | Jan. 01, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2014 |
Share-based Payment Arrangement, Expense | $ 96,000 | $ 904,000 | $ 977,000 | $ 2,647,000 | $ 3,429,000 | $ 3,227,000 | $ 3,343,000 | |||
The 2014 Employee Stock Purchase Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued in Period | 0 | 51,984 | ||||||||
Share-based Payment Arrangement, Expense | $ 0 | $ 20,000 | $ 68,000 | $ 100,000 | ||||||
The 2014 Employee Stock Purchase Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 192,436 | 192,436 | 304,991 | 140,500 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Annual Additional Shares, Percentage | 1.00% | 1.00% | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Maximum Number of Additional Shares Authorizable | 281,000 | 281,000 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued in Period | 0 | 0 | 74,343 | 100,358 | ||||||
Share-based Payment Arrangement, Expense | $ 100,000 | $ 100,000 | $ 100,000 |
Note 6 - Stock-based Compensa_4
Note 6 - Stock-based Compensation - Stock Option Activity for Employees and Non-employees (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |||
Options Outstanding, Beginning Balance (in shares) | 4,597,226 | 2,681,072 | ||||
Options Outstanding, Weighted Average Exercise Price, Beginning Balance (in dollars per share) | $ 5.12 | $ 7.18 | ||||
Options Outstanding, Weighted-average Remaining Contractual Term (Year) | 7 years 109 days | 7 years 146 days | 6 years 292 days | |||
Options Outstanding, Aggregate Intrinsic Value | $ 404 | $ 121 | ||||
Options Granted (in shares) | 1,182,500 | 2,041,600 | 719,337 | 132,495 | ||
Options Granted, Weighted Average Exercise Price (in dollars per share) | $ 2.66 | $ 2.61 | $ 7.11 | |||
Options Exercised (in shares) | ||||||
Options Exercised, Weighted Average Exercise Price (in dollars per share) | ||||||
Options Forfeited (in shares) | (2,606,289) | [1] | (83,433) | |||
Options Forfeited, Weighted Average Exercise Price (in dollars per share) | $ 2.79 | [1] | $ 5.82 | |||
Options Expired (in shares) | (2,400,590) | [1] | (42,013) | |||
Options Expired, Weighted Average Exercise Price (in dollars per share) | $ 6.51 | [1] | $ 13.30 | |||
Options Outstanding, Ending Balance (in shares) | 772,847 | 4,597,226 | 2,681,072 | |||
Options Outstanding, Weighted Average Exercise Price, Ending Balance (in dollars per share) | $ 4.89 | $ 5.12 | $ 7.18 | |||
Options Exercisable (in shares) | 476,390 | 2,067,356 | ||||
Options Exercisable, Weighted Average Exercise Price (in dollars per share) | $ 6.13 | $ 7.57 | ||||
Options Exercisable, Weighted-average Remaining Contractual Term (Year) | 6 years 146 days | 5 years 255 days | ||||
Options Exercisable, Aggregate Intrinsic Value | $ 241 | |||||
Options Vested or Expected to Vest (in shares) | 772,847 | [2] | 4,597,226 | [3] | ||
Options Vested or Expected to Vest, Weighted Average Exercise Price (in dollars per share) | $ 4.89 | [2] | $ 5.12 | [3] | ||
Options Vested or Expected to Vest, Weighted-average Remaining Contractual Term (Year) | 7 years 109 days | [2] | 7 years 146 days | [3] | ||
Options Vested or Expected to Vest, Aggregate Intrinsic Value | [2] | $ 404 | [3] | |||
[1] | Represents the number of options cancelled during the nine months ended September 30, 2019 as a result of employees that were terminated due to the reduction in force. | |||||
[2] | Represents the number of vested options at September 30, 2019 plus the number of unvested options expected to vest based on the unvested options outstanding at September 30, 2019." | |||||
[3] | Represents the number of vested options at December 31, 2018 plus the number of unvested options expected to vest based on the unvested options outstanding at December 31, 2018. |
Note 6 - Stock-based Compensa_5
Note 6 - Stock-based Compensation - Common Stock Reserved for Future Issuance (Details) - shares | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2014 |
Reserved for future issuance (in shares) | 28,707,366 | 27,394,852 | 25,877,695 | |
The 2014 Employee Stock Purchase Plan [Member] | ||||
Reserved for future issuance (in shares) | 118,120 | 118,120 | 192,463 | 140,500 |
Performance Shares [Member] | ||||
Reserved for future issuance (in shares) | 6,818,214 | 5,163,957 | 3,572,457 | |
Conversion of Series A Preferred Stock to Common Stock [Member] | ||||
Reserved for future issuance (in shares) | 21,771,032 | 22,112,775 | 22,112,775 |
Note 7 - Income Taxes (Details
Note 7 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Expense (Benefit), Total | $ 0 | $ 0 |
Note 8 - Net Loss Per Share A_3
Note 8 - Net Loss Per Share Attributable to Common Stockholders - Common Stock Equivalents Excluded From Calculation of Net Loss Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Antidilutive Securities (in shares) | 22,543,879 | 26,736,643 | 22,543,879 | 26,736,643 | 26,710,001 | 24,793,847 | 2,166,254 |
Convertible Preferred Stock [Member] | |||||||
Antidilutive Securities (in shares) | 21,771,032 | 22,112,775 | 21,771,032 | 22,112,775 | 22,112,775 | 22,112,775 | |
Share-based Payment Arrangement, Option [Member] | |||||||
Antidilutive Securities (in shares) | 772,847 | 4,597,226 | 772,847 | 4,597,226 | 4,597,226 | 2,681,072 | 2,166,254 |
Employee Stock Purchase Plan [Member] | |||||||
Antidilutive Securities (in shares) | 26,642 | 26,642 |
Note 9 - Restructuring Charge_2
Note 9 - Restructuring Charges (Details Textual) - USD ($) $ in Thousands | 6 Months Ended | 9 Months Ended |
Dec. 31, 2019 | Sep. 30, 2019 | |
Restructuring Charges, Total | $ 2,854 | |
Forecast [Member] | ||
Restructuring Charges, Total | $ 2,900 |
Note 9 - Restructuring Charge_3
Note 9 - Restructuring Charges - Changes in the Restructuring Accrual (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Beginning balance | |
Charges/(Benefits) | 2,854 |
Payment/Other | (1,834) |
Ending balance | 1,020 |
Employee Severance [Member] | |
Beginning balance | |
Charges/(Benefits) | 2,854 |
Payment/Other | (1,834) |
Ending balance | $ 1,020 |