2019 Q2 Form 10-Q Financial Statement
#000117184319003097 Filed on May 08, 2019
Income Statement
| Concept | 2019 Q2 | 2019 Q1 | 2018 Q1 |
|---|---|---|---|
| Revenue | $0.00 | $0.00 | $0.00 |
| YoY Change | |||
| Cost Of Revenue | |||
| YoY Change | |||
| Gross Profit | |||
| YoY Change | |||
| Gross Profit Margin | |||
| Selling, General & Admin | $3.270M | $2.590M | $2.290M |
| YoY Change | 45.98% | 13.1% | 2.69% |
| % of Gross Profit | |||
| Research & Development | $2.120M | $4.048M | $4.071M |
| YoY Change | -23.19% | -0.56% | -4.12% |
| % of Gross Profit | |||
| Depreciation & Amortization | $21.00K | $174.0K | $32.00K |
| YoY Change | -27.59% | 443.75% | -20.0% |
| % of Gross Profit | |||
| Operating Expenses | $5.386M | $6.637M | $6.365M |
| YoY Change | 7.72% | 4.27% | -1.77% |
| Operating Profit | -$5.386M | -$6.637M | -$6.365M |
| YoY Change | 7.72% | 4.27% | -1.77% |
| Interest Expense | $70.00K | $110.0K | $90.00K |
| YoY Change | -36.36% | 22.22% | 200.0% |
| % of Operating Profit | |||
| Other Income/Expense, Net | $71.00K | $106.0K | $284.0K |
| YoY Change | -41.32% | -62.68% | -1677.78% |
| Pretax Income | -$5.320M | -$6.530M | -$6.080M |
| YoY Change | 9.02% | 7.4% | -6.46% |
| Income Tax | $0.00 | $0.00 | |
| % Of Pretax Income | |||
| Net Earnings | -$5.315M | -$6.531M | -$6.081M |
| YoY Change | 8.94% | 7.4% | -6.42% |
| Net Earnings / Revenue | |||
| Basic Earnings Per Share | |||
| Diluted Earnings Per Share | -$10.86M | -$13.60M | -$13.82M |
| COMMON SHARES | |||
| Basic Shares Outstanding | 19.59M | 19.24M | |
| Diluted Shares Outstanding |
Balance Sheet
| Concept | 2019 Q2 | 2019 Q1 | 2018 Q1 |
|---|---|---|---|
| SHORT-TERM ASSETS | |||
| Cash & Short-Term Investments | $10.80M | $16.80M | $36.80M |
| YoY Change | -59.25% | -54.35% | 7.92% |
| Cash & Equivalents | $10.81M | $16.76M | $25.36M |
| Short-Term Investments | $0.00 | $0.00 | $11.50M |
| Other Short-Term Assets | $700.0K | $1.100M | $1.200M |
| YoY Change | -36.36% | -8.33% | -7.69% |
| Inventory | |||
| Prepaid Expenses | |||
| Receivables | |||
| Other Receivables | |||
| Total Short-Term Assets | $11.50M | $17.93M | $38.03M |
| YoY Change | -58.22% | -52.85% | 7.48% |
| LONG-TERM ASSETS | |||
| Property, Plant & Equipment | $83.00K | $105.0K | $236.0K |
| YoY Change | -62.1% | -55.51% | -30.18% |
| Goodwill | |||
| YoY Change | |||
| Intangibles | |||
| YoY Change | |||
| Long-Term Investments | |||
| YoY Change | |||
| Other Assets | $0.00 | $0.00 | $240.0K |
| YoY Change | -100.0% | -100.0% | -19.73% |
| Total Long-Term Assets | $105.0K | $127.0K | $476.0K |
| YoY Change | -69.21% | -73.32% | -25.27% |
| TOTAL ASSETS | |||
| Total Short-Term Assets | $11.50M | $17.93M | $38.03M |
| Total Long-Term Assets | $105.0K | $127.0K | $476.0K |
| Total Assets | $11.60M | $18.06M | $38.51M |
| YoY Change | -58.35% | -53.1% | 6.9% |
| SHORT-TERM LIABILITIES | |||
| YoY Change | |||
| Accounts Payable | $60.00K | $1.676M | $7.016M |
| YoY Change | -86.08% | -76.11% | 1380.17% |
| Accrued Expenses | $1.995M | $1.559M | $2.004M |
| YoY Change | 10.83% | -22.21% | -21.38% |
| Deferred Revenue | |||
| YoY Change | |||
| Short-Term Debt | $0.00 | $0.00 | $0.00 |
| YoY Change | |||
| Long-Term Debt Due | |||
| YoY Change | |||
| Total Short-Term Liabilities | $2.123M | $3.370M | $9.020M |
| YoY Change | -4.84% | -62.64% | 198.38% |
| LONG-TERM LIABILITIES | |||
| Long-Term Debt | $0.00 | $0.00 | $0.00 |
| YoY Change | |||
| Other Long-Term Liabilities | |||
| YoY Change | |||
| Total Long-Term Liabilities | $0.00 | $0.00 | $0.00 |
| YoY Change | |||
| TOTAL LIABILITIES | |||
| Total Short-Term Liabilities | $2.123M | $3.370M | $9.020M |
| Total Long-Term Liabilities | $0.00 | $0.00 | $0.00 |
| Total Liabilities | $2.123M | $3.370M | $9.020M |
| YoY Change | -4.84% | -62.64% | 198.38% |
| SHAREHOLDERS EQUITY | |||
| Retained Earnings | -$222.3M | -$217.0M | -$195.8M |
| YoY Change | 10.77% | 10.82% | 17.77% |
| Common Stock | $19.00K | $19.00K | $18.00K |
| YoY Change | 5.56% | 5.56% | 5.88% |
| Preferred Stock | |||
| YoY Change | |||
| Treasury Stock (at cost) | |||
| YoY Change | |||
| Treasury Stock Shares | |||
| Shareholders Equity | $9.477M | $14.69M | $29.49M |
| YoY Change | |||
| Total Liabilities & Shareholders Equity | $11.60M | $18.06M | $38.51M |
| YoY Change | -58.35% | -53.1% | 6.9% |
Cashflow Statement
| Concept | 2019 Q2 | 2019 Q1 | 2018 Q1 |
|---|---|---|---|
| OPERATING ACTIVITIES | |||
| Net Income | -$5.315M | -$6.531M | -$6.081M |
| YoY Change | 8.94% | 7.4% | -6.42% |
| Depreciation, Depletion And Amortization | $21.00K | $174.0K | $32.00K |
| YoY Change | -27.59% | 443.75% | -20.0% |
| Cash From Operating Activities | -$5.950M | -$5.092M | -$5.456M |
| YoY Change | -42.46% | -6.67% | -26.73% |
| INVESTING ACTIVITIES | |||
| Capital Expenditures | $0.00 | $16.00K | $9.000K |
| YoY Change | -100.0% | 77.78% | 50.0% |
| Acquisitions | |||
| YoY Change | |||
| Other Investing Activities | $0.00 | $2.500M | $9.510M |
| YoY Change | -100.0% | -73.71% | 93.29% |
| Cash From Investing Activities | $0.00 | $2.484M | $9.505M |
| YoY Change | -100.0% | -73.87% | 93.43% |
| FINANCING ACTIVITIES | |||
| Cash Dividend Paid | |||
| YoY Change | |||
| Common Stock Issuance & Retirement, Net | |||
| YoY Change | |||
| Debt Paid & Issued, Net | |||
| YoY Change | |||
| Cash From Financing Activities | 0.000 | ||
| YoY Change | -100.0% | ||
| NET CHANGE | |||
| Cash From Operating Activities | -5.950M | -5.092M | -5.456M |
| Cash From Investing Activities | 0.000 | 2.484M | 9.505M |
| Cash From Financing Activities | 0.000 | ||
| Net Change In Cash | -5.950M | -2.608M | 4.186M |
| YoY Change | -53.37% | -162.3% | -285.22% |
| FREE CASH FLOW | |||
| Cash From Operating Activities | -$5.950M | -$5.092M | -$5.456M |
| Capital Expenditures | $0.00 | $16.00K | $9.000K |
| Free Cash Flow | -$5.950M | -$5.108M | -$5.465M |
| YoY Change | -42.4% | -6.53% | -26.66% |
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<div style="display: inline; font-family: times new roman; font-size: 10pt"><div style=" text-align: justify; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><div style="display: inline; font-size: 10pt"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">1.</div></div></div> <div style="display: inline; font-size: 10pt"><div style="display: inline; font-weight: bold;">Organization and Operations</div></div></div> <div style=" font-size: 10pt; text-align: justify; margin: 0pt 0"><div style="display: inline; font-weight: bold;"> </div></div> <div style=" font-size: 10pt; text-align: justify; margin: 0pt 0"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic;">The Company</div></div></div> <div style=" font-size: 10pt; text-align: justify; margin: 0pt 0"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic;"> </div></div></div> <div style=" font-size: 10pt; text-align: justify; text-indent: 0.25in; margin: 0pt 0">Proteon Therapeutics, Inc. (the “Company”) is a biopharmaceutical company that has historically focused on the development of novel, <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">first</div>-in-class pharmaceuticals to address the medical needs of patients with kidney and vascular disease. The Company was formed in <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> June 2001 </div>and incorporated on <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> March 24, 2006.</div></div> <div style=" font-size: 10pt; text-align: justify; text-indent: 29.7pt; margin: 0pt 0"> </div> <div style=" font-size: 10pt; text-align: justify; text-indent: 16.65pt; margin: 0pt 0">On <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> June 22, 2017, </div>the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a syndicate of current and new institutional investors, led by an affiliate of Deerfield Management Company, L.P., pursuant to which the Company agreed to issue and sell to the investors an aggregate of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">22,000</div> shares of the Company’s Series A Convertible Preferred Stock, par value <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$0.001</div> per share (the “Series A Preferred”), for a purchase price of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$1,000</div> per share, or an aggregate gross purchase price of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$22.0</div> million, all upon the terms and conditions set forth in the Purchase Agreement (the “Series A Financing”). The Company closed the Series A Financing on <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> August 2, 2017 (</div>see Note <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">6</div>).</div> <div style=" font-size: 10pt; text-align: justify; margin: 0pt 0"> </div> <div style=" font-size: 10pt; text-align: justify; text-indent: 0.25in; margin: 0pt 0"></div> <div style=" font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">Pursuant to the Series A Financing, on <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> August 2, 2017, </div>the Company entered into a registration rights agreement with the holders of the Series A Preferred (the “Registration Rights Agreement”). On <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> August 3, 2017, </div>in accordance with the Registration Rights Agreement, the Company filed a registration statement on Form S-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">3</div> to register the common stock issuable upon conversion of the Series A Preferred. The registration statement became effective on <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> August 21, 2017. </div>As of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> March 31, 2019, </div><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">340</div> shares of the Series A Preferred were converted into <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">341,743</div> shares of the Company’s common Stock.</div> <div style=" font-size: 10pt; text-align: justify; text-indent: 0.25in; margin: 0pt 0"> </div> <div style=" font-size: 10pt; text-align: justify; margin: 0pt 0"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic;">Recent Developments</div></div></div> <div style=" font-size: 10pt; text-align: justify; margin: 0pt 0"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic;"> </div></div></div> <div style=" font-size: 10pt; text-indent: 0.25in; margin: 0pt 0">On <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> March 28, 2019, </div>the Company announced top-line results from PATENCY-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2,</div> its Phase <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">3</div> clinical trial of investigational vonapanitase in patients with chronic kidney disease, or CKD, undergoing creation of a radiocephalic fistula for hemodialysis. The PATENCY-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2</div> clinical trial had <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">two</div> co-primary endpoints:</div> <div style=" font-size: 10pt; text-indent: 0.25in; margin: 0pt 0"> </div> <div style=" font-size: 10pt; text-indent: 0.25in; margin: 0pt 0"></div> <table style="border-collapse: collapse; font: 10pt Times New Roman, Times, Serif; min-width: 700px;" cellspacing="0" cellpadding="0"> <tr style="vertical-align: top; text-align: left"> <td style="text-align: center">•</td> <td colspan="2"><div style="display: inline; font-style: italic;">Fistula use for hemodialysis</div>. <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">69.7</div> % of vonapanitase-treated patients achieved use of the fistula for hemodialysis, compared to <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">65.1%</div> of placebo-treated patients (<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">p=0.328</div>), a result that is <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> statistically significant. Fistula use is defined as use of the fistula for <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">two</div>-needle hemodialysis for at least <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">90</div> days or, if hemodialysis was <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> initiated at least <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">90</div> days prior to the last study visit, for at least <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">30</div> days and including the patient’s last study visit.</td> </tr> <tr style="vertical-align: top; text-align: left"> <td style="text-align: center"> </td> <td colspan="2"> </td> </tr> <tr style="vertical-align: top; text-align: left"> <td style="text-align: center">•</td> <td colspan="2"><div style="display: inline; font-style: italic;">Secondary patency</div>. A comparison of the Kaplan-Meier curves did <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> demonstrate a statistically significant difference in favor of vonapanitase (<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">p=0.932</div>). At the end of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">one</div> year, <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">78%</div> of vonapanitase-treated patients maintained secondary patency, compared to <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">76%</div> of placebo-treated patients. Secondary patency is a measure of the length of time from surgical creation of the fistula until the fistula experiences final failure and must be abandoned.</td> </tr> <tr style="vertical-align: top; text-align: left"> <td style="width: 6%; text-align: center"> </td> <td style="width: 61%"> </td> <td style="width: 33%"> </td> </tr> </table> <div style=" font-size: 10pt; text-indent: 0.25in; margin: 0pt 0"></div> <div style=" font-size: 10pt; text-indent: 0.25in; margin: 0pt 0"></div> <div style=" font-size: 10pt; margin: 0pt 0 0pt 0.25in"></div> <div style=" font-size: 10pt; text-indent: 0.25in; margin: 0pt 0"></div> <div style=" font-size: 10pt; text-indent: 0.25in; margin: 0pt 0">Top-line results also included data relating to primary unassisted patency, <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">one</div> of PATENCY-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2’s</div> other efficacy endpoints. Primary unassisted patency is the length of time from fistula surgical creation to the <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">first</div> occurrence of a fistula thrombosis or corrective procedure to restore or maintain patency (blood flow). Vonapanitase-treated patients had a <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">15%</div> reduction in the risk of primary unassisted patency loss over <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">one</div> year, compared to placebo (<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">p=0.178</div>), a result that is <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> statistically significant.</div> <div style=" font-size: 10pt; text-indent: 0.25in; margin: 0pt 0"> </div> <div style=" font-size: 10pt; text-indent: 0.25in; margin: 0pt 0">The proportions of patients experiencing adverse events were comparable between the vonapanitase and placebo arms of the study. The most common adverse events were consistent with medical events experienced by patients with CKD undergoing creation of a radiocephalic fistula and are summarized in the table below.</div> <div style=" font-size: 10pt; text-indent: 0.25in; margin: 0pt 0"> </div> <div style=" font-size: 10pt; text-indent: 0.25in; margin: 0pt 0"></div> <!-- Field: Page; Sequence: 9; Value: 1 --> <div style=" font-size: 10pt; text-indent: 0.25in; margin: 0pt 0"></div> <div style=" font-size: 10pt; text-indent: 0.25in; margin: 0pt 0"><div style="display: inline; font-style: italic;">Proportions of Patients Experiencing Common Adverse Events</div></div> <div style=" font-size: 10pt; text-indent: 0.25in; margin: 0pt 0"> </div> <div> <table style="border-collapse: collapse; min-width: 700px;" cellspacing="0" cellpadding="0"> <tr style="vertical-align: bottom"> <td style="font-size: 10pt; border-top: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid"> </td> <td style="font-size: 10pt; border-bottom: Black 1pt solid; border-top: Black 1pt solid"> </td> <td colspan="3" style="font-size: 10pt; text-align: center; border-bottom: Black 1pt solid; border-top: Black 1pt solid">Vonapanitase <br />N=399</td> <td style="font-size: 10pt; border-bottom: Black 1pt solid; border-top: Black 1pt solid"> </td> <td colspan="3" style="font-size: 10pt; text-align: center; border-bottom: Black 1pt solid; border-top: Black 1pt solid; border-right: Black 1pt solid">Placebo <br />N=204</td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 74%; font-size: 10pt; text-align: left; padding-bottom: 1pt; text-indent: 0.25in; border-left: Black 1pt solid; border-bottom: Black 1pt solid">Vascular Stenosis</td> <td style="width: 1%; font-size: 10pt; border-bottom: Black 1pt solid"> </td> <td style="width: 1%; border-bottom: Black 1pt solid; font-size: 10pt; text-align: left"> </td> <td style="width: 10%; border-bottom: Black 1pt solid; font-size: 10pt; text-align: right"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">35.1</div></td> <td style="width: 1%; border-bottom: Black 1pt solid; font-size: 10pt; text-align: left">%</td> <td style="width: 1%; font-size: 10pt; border-bottom: Black 1pt solid"> </td> <td style="width: 1%; border-bottom: Black 1pt solid; font-size: 10pt; text-align: left"> </td> <td style="width: 10%; border-bottom: Black 1pt solid; font-size: 10pt; text-align: right"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">41.7</div></td> <td style="width: 1%; border-bottom: Black 1pt solid; font-size: 10pt; text-align: left; border-right: Black 1pt solid">%</td> </tr> <tr style="vertical-align: bottom; background-color: White"> <td style="font-size: 10pt; text-align: left; padding-bottom: 1pt; text-indent: 0.25in; border-left: Black 1pt solid; border-bottom: Black 1pt solid">Fistula Thrombosis</td> <td style="font-size: 10pt; border-bottom: Black 1pt solid"> </td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: left"> </td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: right"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">16.8</div></td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: left">%</td> <td style="font-size: 10pt; border-bottom: Black 1pt solid"> </td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: left"> </td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: right"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">18.6</div></td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: left; border-right: Black 1pt solid">%</td> </tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="font-size: 10pt; text-align: left; padding-bottom: 1pt; text-indent: 0.25in; border-left: Black 1pt solid; border-bottom: Black 1pt solid">Local swelling</td> <td style="font-size: 10pt; border-bottom: Black 1pt solid"> </td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: left"> </td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: right"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">5.0</div></td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: left">%</td> <td style="font-size: 10pt; border-bottom: Black 1pt solid"> </td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: left"> </td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: right"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2.0</div></td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: left; border-right: Black 1pt solid">%</td> </tr> <tr style="vertical-align: bottom; background-color: White"> <td style="font-size: 10pt; padding-bottom: 1pt; text-indent: 0.25in; border-left: Black 1pt solid; border-bottom: Black 1pt solid">Hematoma</td> <td style="font-size: 10pt; border-bottom: Black 1pt solid"> </td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: left"> </td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: right"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">5.0</div></td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: left">%</td> <td style="font-size: 10pt; border-bottom: Black 1pt solid"> </td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: left"> </td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: right"><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">3.9</div></td> <td style="border-bottom: Black 1pt solid; font-size: 10pt; text-align: left; border-right: Black 1pt solid">%</td> </tr> </table> </div> <div style=" font-size: 10pt; text-indent: 0.5in; margin: 0pt 0"> </div> <div style=" font-size: 10pt; text-align: justify; text-indent: 16.65pt; margin: 0pt 0">Note: Includes any adverse event that occurred in at least <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">5%</div> of patients in either treatment group.</div> <div style=" font-size: 10pt; text-align: justify; margin: 0pt 0"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic;"> </div></div></div> <div style=" font-size: 10pt; text-align: justify; margin: 0pt 0"><div style="display: inline; font-weight: bold;"><div style="display: inline; font-style: italic;">Current Strategy</div></div></div> <div style=" font-size: 10pt; text-align: justify; text-indent: 0.25in; margin: 0pt 0"> </div> <div style=" font-size: 10pt; text-align: justify; text-indent: 0.25in; margin: 0pt 0"></div> <div style=" font-size: 10pt; text-align: justify; text-indent: 0.25in; margin: 0pt 0">Following the release of top-line data from the PATENCY-<div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2</div> clinical trial of vonapanitase on <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> March 28, 2019, </div>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 <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> 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. Since these efforts <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> may </div><div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">not</div> be successful, it is also considering other possible alternatives, including a wind-down of operations and a liquidation and dissolution of the Company. The Company has discontinued substantially all its research and development activities (see Note <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">10</div>), including a reduction in workforce, to reduce operating expenses while it evaluates these opportunities. 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 <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">third</div> parties and product liability.</div> <div style=" font-size: 10pt; text-align: justify; text-indent: 29.7pt; margin: 0pt 0"> </div> <div style=" font-size: 10pt; text-align: justify; text-indent: 0.25in; margin: 0pt 0"></div> <div style=" font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">As of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> March 31, 2019, </div>the Company had cash, cash equivalents and available-for-sale investments of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$16.8</div> million. The Company believes that its existing cash, cash equivalents and available-for-sale investments will be sufficient to fund operations and capital expenditures into <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">2020.</div> The Company had an accumulated deficit of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">$217.0</div> million as of <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;"> March 31, 2019. </div>The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to its administrative organization. These conditions raise substantial doubt about its ability to continue as a going concern within <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">one</div> 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 is currently exploring strategic alternatives as a source of funding. While the current reduction in spending expenditure plans will allow the Company to fund its operations in the near-term, there can be <div style="display: inline; font-style: italic; font-weight: inherit; font-style: normal;">no</div> 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. Accordingly, the Company has prepared the financial statements on the going concern basis.</div></div> | |
| CY2019Q1 | us-gaap |
Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
|
2484000 | |
| CY2018Q1 | us-gaap |
Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
|
9505000 | |
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Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-5092000 | |
| CY2018Q1 | us-gaap |
Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-5456000 | |
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Net Income Loss
NetIncomeLoss
|
-6531000 | |
| CY2018Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-6081000 | |
| CY2019Q1 | us-gaap |
Net Income Loss Available To Common Stockholders Basic
NetIncomeLossAvailableToCommonStockholdersBasic
|
-6531000 | |
| CY2018Q1 | us-gaap |
Net Income Loss Available To Common Stockholders Basic
NetIncomeLossAvailableToCommonStockholdersBasic
|
-6081000 | |
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Nonoperating Income Expense
NonoperatingIncomeExpense
|
106000 | |
| CY2018Q1 | us-gaap |
Nonoperating Income Expense
NonoperatingIncomeExpense
|
284000 | |
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Operating Expenses
OperatingExpenses
|
6637000 | |
| CY2018Q1 | us-gaap |
Operating Expenses
OperatingExpenses
|
6365000 | |
| CY2019Q1 | us-gaap |
Operating Income Loss
OperatingIncomeLoss
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-6637000 | |
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Operating Income Loss
OperatingIncomeLoss
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-6365000 | |
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Operating Lease Expense
OperatingLeaseExpense
|
69000 | |
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Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
|
135000 | |
| CY2018Q4 | us-gaap |
Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
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| CY2019Q1 | us-gaap |
Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
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135000 | |
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Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
|
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| CY2019Q1 | us-gaap |
Operating Lease Weighted Average Discount Rate Percent
OperatingLeaseWeightedAverageDiscountRatePercent
|
0.08 | |
| CY2019Q1 | us-gaap |
Operating Lease Weighted Average Remaining Lease Term1
OperatingLeaseWeightedAverageRemainingLeaseTerm1
|
P182D | |
| CY2019Q1 | us-gaap |
Other Comprehensive Income Foreign Currency Transaction And Translation Adjustment Net Of Tax Portion Attributable To Parent
OtherComprehensiveIncomeForeignCurrencyTransactionAndTranslationAdjustmentNetOfTaxPortionAttributableToParent
|
-2000 | |
| CY2018Q1 | us-gaap |
Other Comprehensive Income Foreign Currency Transaction And Translation Adjustment Net Of Tax Portion Attributable To Parent
OtherComprehensiveIncomeForeignCurrencyTransactionAndTranslationAdjustmentNetOfTaxPortionAttributableToParent
|
2000 | |
| CY2019Q1 | us-gaap |
Other Comprehensive Income Loss Net Of Tax Portion Attributable To Parent
OtherComprehensiveIncomeLossNetOfTaxPortionAttributableToParent
|
-2000 | |
| CY2018Q1 | us-gaap |
Other Comprehensive Income Loss Net Of Tax Portion Attributable To Parent
OtherComprehensiveIncomeLossNetOfTaxPortionAttributableToParent
|
10000 | |
| CY2019Q1 | us-gaap |
Other Comprehensive Income Unrealized Holding Gain Loss On Securities Arising During Period Net Of Tax
OtherComprehensiveIncomeUnrealizedHoldingGainLossOnSecuritiesArisingDuringPeriodNetOfTax
|
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| CY2018Q1 | us-gaap |
Other Comprehensive Income Unrealized Holding Gain Loss On Securities Arising During Period Net Of Tax
OtherComprehensiveIncomeUnrealizedHoldingGainLossOnSecuritiesArisingDuringPeriodNetOfTax
|
8000 | |
| CY2019Q1 | us-gaap |
Other Nonoperating Income Expense
OtherNonoperatingIncomeExpense
|
1000 | |
| CY2018Q1 | us-gaap |
Other Nonoperating Income Expense
OtherNonoperatingIncomeExpense
|
192000 | |
| CY2019Q1 | us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
16000 | |
| CY2018Q1 | us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
9000 | |
| CY2019Q1 | us-gaap |
Preferred Stock Par Or Stated Value Per Share
PreferredStockParOrStatedValuePerShare
|
0.001 | |
| CY2018Q4 | us-gaap |
Preferred Stock Par Or Stated Value Per Share
PreferredStockParOrStatedValuePerShare
|
0.001 | |
| CY2019Q1 | us-gaap |
Preferred Stock Shares Authorized
PreferredStockSharesAuthorized
|
10000000 | |
| CY2018Q4 | us-gaap |
Preferred Stock Shares Authorized
PreferredStockSharesAuthorized
|
10000000 | |
| CY2019Q1 | us-gaap |
Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
|
1035000 | |
| CY2018Q4 | us-gaap |
Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
|
1369000 | |
| CY2019Q1 | us-gaap |
Proceeds From Maturities Prepayments And Calls Of Available For Sale Securities
ProceedsFromMaturitiesPrepaymentsAndCallsOfAvailableForSaleSecurities
|
2500000 | |
| CY2018Q1 | us-gaap |
Proceeds From Maturities Prepayments And Calls Of Available For Sale Securities
ProceedsFromMaturitiesPrepaymentsAndCallsOfAvailableForSaleSecurities
|
7515000 | |
| CY2019Q1 | us-gaap |
Proceeds From Sale Of Available For Sale Securities
ProceedsFromSaleOfAvailableForSaleSecurities
|
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| CY2018Q1 | us-gaap |
Proceeds From Sale Of Available For Sale Securities
ProceedsFromSaleOfAvailableForSaleSecurities
|
1999000 | |
| CY2018Q4 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
|
404000 | |
| CY2019Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
|
||
| CY2018Q4 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
|
4597226 | |
| CY2019Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
|
5779726 | |
| CY2018Q4 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
|
5.12 | |
| CY2019Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
|
4.62 | |
| CY2019Q1 | us-gaap |
Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
|
1106000 | |
| CY2018Q4 | us-gaap |
Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
|
1090000 | |
| CY2019Q1 | us-gaap |
Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
|
105000 | |
| CY2018Q4 | us-gaap |
Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
|
263000 | |
| CY2019Q1 | us-gaap |
Research And Development Expense
ResearchAndDevelopmentExpense
|
4048000 | |
| CY2018Q1 | us-gaap |
Research And Development Expense
ResearchAndDevelopmentExpense
|
4071000 | |
| CY2019Q1 | us-gaap |
Restricted Cash And Cash Equivalents
RestrictedCashAndCashEquivalents
|
22000 | |
| CY2018Q1 | us-gaap |
Restricted Cash And Cash Equivalents
RestrictedCashAndCashEquivalents
|
22000 | |
| CY2019Q1 | us-gaap |
Restricted Cash Noncurrent
RestrictedCashNoncurrent
|
22000 | |
| CY2018Q4 | us-gaap |
Restricted Cash Noncurrent
RestrictedCashNoncurrent
|
22000 | |
| CY2019Q1 | us-gaap |
Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
|
-217001000 | |
| CY2018Q4 | us-gaap |
Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
|
-210470000 | |
| CY2019Q1 | us-gaap |
Security Deposit
SecurityDeposit
|
22000 | |
| CY2019Q1 | us-gaap |
Share Based Compensation
ShareBasedCompensation
|
780000 | |
| CY2018Q1 | us-gaap |
Share Based Compensation
ShareBasedCompensation
|
821000 | |
| CY2019Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber
|
2606279 | |
| CY2019Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice
|
6.75 | |
| CY2019Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Expirations In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExpirationsInPeriod
|
||
| CY2019Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod
|
||
| CY2019Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Gross
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross
|
1182500 | |
| CY2019Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Expected To Vest Outstanding Aggregate Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingAggregateIntrinsicValue
|
||
| CY2019Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Expected To Vest Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingNumber
|
5779726 | |
| CY2019Q1 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Expected To Vest Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageExercisePrice
|
4.62 | |
| CY2019Q1 | us-gaap |
Share Based Compensation Arrangements By Share Based Payment Award Options Exercises In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisePrice
|
||
| CY2019Q1 | us-gaap |
Share Based Compensation Arrangements By Share Based Payment Award Options Expirations In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExpirationsInPeriodWeightedAverageExercisePrice
|
||
| CY2019Q1 | us-gaap |
Share Based Compensation Arrangements By Share Based Payment Award Options Forfeitures In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisePrice
|
||
| CY2019Q1 | us-gaap |
Share Based Compensation Arrangements By Share Based Payment Award Options Grants In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice
|
2.66 | |
| CY2019Q1 | us-gaap |
Sharebased Compensation Arrangement By Sharebased Payment Award Options Exercisable Intrinsic Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsExercisableIntrinsicValue1
|
||
| CY2019Q1 | us-gaap |
Sharebased Compensation Arrangement By Sharebased Payment Award Options Exercisable Weighted Average Remaining Contractual Term1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsExercisableWeightedAverageRemainingContractualTerm1
|
P6Y36D | |
| CY2018 | us-gaap |
Sharebased Compensation Arrangement By Sharebased Payment Award Options Outstanding Weighted Average Remaining Contractual Term2
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2
|
P7Y146D | |
| CY2019Q1 | us-gaap |
Sharebased Compensation Arrangement By Sharebased Payment Award Options Outstanding Weighted Average Remaining Contractual Term2
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2
|
P7Y146D | |
| CY2019Q1 | us-gaap |
Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested And Expected To Vest Outstanding Weighted Average Remaining Contractual Term1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageRemainingContractualTerm1
|
P7Y146D | |
| CY2019Q1 | us-gaap |
Stock Issued During Period Shares Stock Options Exercised
StockIssuedDuringPeriodSharesStockOptionsExercised
|
||
| CY2018Q1 | us-gaap |
Stock Issued During Period Value Employee Stock Purchase Plan
StockIssuedDuringPeriodValueEmployeeStockPurchasePlan
|
||
| CY2018Q1 | us-gaap |
Stock Issued During Period Value New Issues
StockIssuedDuringPeriodValueNewIssues
|
||
| CY2019Q1 | us-gaap |
Stockholders Equity
StockholdersEquity
|
14690000 | |
| CY2018Q4 | us-gaap |
Stockholders Equity
StockholdersEquity
|
20443000 | |
| CY2017Q4 | us-gaap |
Stockholders Equity
StockholdersEquity
|
34739000 | |
| CY2018Q1 | us-gaap |
Stockholders Equity
StockholdersEquity
|
29489000 | |
| CY2019Q1 | us-gaap |
Weighted Average Number Of Share Outstanding Basic And Diluted
WeightedAverageNumberOfShareOutstandingBasicAndDiluted
|
19255042 | |
| CY2018Q1 | us-gaap |
Weighted Average Number Of Share Outstanding Basic And Diluted
WeightedAverageNumberOfShareOutstandingBasicAndDiluted
|
17674729 |
