Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2017

At-the-market Equity Offering Program [Policy Text Block]

At-The-Market Equity Offering Program

November 12, 2015,

the Company filed a shelf registration statement on Form S-

(the “Registration Statement”), and entered into a Sales Agreement with Cowen and Company, LLC (the “Sales Agreement”) to establish an at-the-market (“ATM”) equity offering program pursuant to which they are able, with the Company’s authorization, to offer and sell up to

$40

million of the Company’s Common Stock at prevailing market prices from time to time. The Registration Statement became effective on

January 12, 2016.

The Company pays Cowen a commission equal to

of the gross proceeds of the sales price of all shares sold through it as sales agent under the Sales Agreement. The offering costs are offset against proceeds from the sale of common stock under this agreement. The Company filed a prospectus supplement on

March 16, 2017

because the Company is currently subject to General Instruction

I.B.6

of Form S-

which limits the amounts that the Company

may

sell under the Registration Statement. For the year ended

December 31, 2017,

the Company sold

896,811

shares of Common Stock under the Sales Agreement for aggregate gross proceeds of

$1.4

million, respectively. For the year ending

December 31, 2017,

total offering costs of

$0.1

million were offset against the proceeds from the sale of common stock.

Convertible Preferred Stock, Policy [Policy Text Block]

Series A Preferred Financing

June 22, 2017,

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

22,000

shares of the Company’s Series A Convertible Preferred Stock, par value

$0.001

per share (the “Transaction”), for a purchase price of

$1,000

per share, or an aggregate gross purchase price of

$22.0

million, all upon the terms and conditions set forth in the Purchase Agreement. The Company closed this Transaction on

August 2, 2017 (

see Note

August 2, 2017,

the Company entered into a registration rights agreement with the Investors (the “Registration Rights Agreement”). On

August 3, 2017,

in accordance with the Registration Rights Agreement, the Company filed a registration statement on Form S-

to register the common stock issuable upon conversion of the Preferred Shares. The registration statement became effective on

August 21, 2017.

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

limited to, estimates related to stock-based compensation expense, clinical trial accruals and reported amounts of expenses during the reported period. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results

may

differ from those estimates or assumptions.

Basis of Accounting, Policy [Policy Text Block]

Basis of Presentation, Principles of Consolidation and Use of Estimates

not

may

differ from those estimates or assumptions.

Segment Reporting, Policy [Policy Text Block]

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

operating segment, which is the business of developing and commercializing vonapanitase for the treatment of renal and vascular disease. Currently, the Company operates in only

one

geographic segment.

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, forward foreign currency contracts (see Note

), 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

, established a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the financial instrument based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the financial instrument and are developed based on the best information available under the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported or disclosed fair value of the financial instruments and is

not

a measure of the investment credit quality. Fair value measurements are classified and disclosed in

one

of the following

three

categories:

Level

1—Valuations

based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

Level

2—Valuations

based on quoted prices for similar assets or liabilities in markets that are

not

active or for which all significant inputs are observable, either directly or indirectly.

Level

3—Valuations

that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and unobservable.

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

A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.

Financial instruments measured at fair value on a recurring basis include cash equivalents, available-for-sale investments and forward foreign currency contracts (see Note

). There have been

changes to the valuation methods utilized by the Company during the years ended

December 31, 2017

and

2016.

The Company evaluates transfers between levels at the end of each reporting period. There were

transfers of financial instruments between levels during the years ended

December 31, 2017

and

2016.

Derivatives, Policy [Policy Text Block]

Derivative Financial Instruments

The Company enters into forward foreign currency contracts to mitigate its exposure to fluctuations in the exchange rates between the Swiss Franc and the U.S. dollar (see Note

). The Company records these derivative financial instruments on the consolidated balance sheets at fair value. Although these derivative contracts are intended to economically hedge foreign exchange risk, the Company has

not

elected to apply hedge accounting. As such, changes in the fair value of these instruments are recorded directly in earnings as a component of other income (expense), as they occur. The Company executes its derivative instruments with financial institutions that the Company judges to be credit-worthy, defined as institutions that hold an investment-grade credit rating.

New Accounting Pronouncements, Policy [Policy Text Block]

Recent Accounting Pronouncements

May 2014,

the FASB issued ASU

2014

09,

“Revenue from Contracts with Customers”

(“ASU

2014

09”

), a new standard on revenue recognition providing a single, comprehensive revenue recognition model for all contracts with customers. The new revenue standard is based on the principle that revenue should be recognized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The new standard is effective beginning

January 1, 2018,

with

early adoption permitted. Earlier application is permitted only as of annual reporting periods beginning after

December 15, 2016,

including interim reporting periods within that reporting period. The amendments

may

be applied retrospectively to each prior period presented or retrospectively with the cumulative effect recognized as of the date of initial application. The Company does

not

expect this guidance to have a material impact on its condensed consolidated financial statements, if any.

February 2016,

the FASB issued ASU

2016

02,

Leases (Topic

842

): Amendments to FASB Codification

(“ASU

2016

02”

), which increases transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. At the lease commencement date, the lessee must recognize a lease liability and right-of-use asset, which is initially measured at the present value of future lease payments. ASU

2016

is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after

December 15, 2018,

with early adoption permitted. ASU

2016

must be adopted using a modified retrospective transition, and provides for certain practical expedients. Transition will require application of the new guidance at the beginning of the earliest comparative period presented. The Company is currently evaluating the impact of the new guidance on its consolidated financial statements.

March 2016,

the FASB issued ASU

2016

09,

Compensation - Stock Compensation (Topic

718

): Improvements to Employee Share-Based Payment Accounting

(“ASU

2016

09”

), which simplifies various aspects of the accounting for share-based payments, including accounting for income taxes, earnings per share, and forfeitures. ASU

2016

is effective for annual periods beginning after

December 15, 2016,

and interim periods within those annual periods with early adoption permitted. The Company adopted ASU

2016

during the quarter ended

March 31, 2017.

As a result of adoption, the deferred tax assets associated with net operating losses increased by

$0.6

million. These amounts were offset by a corresponding increase in the valuation allowance. In addition, the Company has elected to recognize the effect of forfeitures in compensation cost when they occur rather than estimate forfeitures in advance. The Company will reverse any previously recognized compensation cost for an award in the period that the award is forfeited. The adoption had an immaterial impact on the condensed consolidated financial statements.

August 2016,

the FASB issued ASU

2016

15,

Statement of Cash Flows (Topic

230

): Classification of Certain Cash Receipts and Cash Payments

(“ASU

2016

15”

), which provides clarification regarding how certain cash receipts and cash payment are presented and classified in the statement of cash flows. This update addresses

eight

specific cash flow issues with the objective of reducing the existing diversity in practice. This update is effective for annual and interim periods beginning after

December 15, 2017,

which will require the Company to adopt these provisions in the

first

quarter of fiscal

2019

using a retrospective approach. Early adoption is permitted. The Company does

not

expect the adoption of this guidance to have a material impact on its consolidated financial statements.

May 2017,

the FASB issued ASU

No.

2017

09,

Compensation - Stock Compensation (Topic

718

): Scope of Modification Accounting

(“ASU

2017

09”

), which clarifies when changes to the terms or conditions of a share-based payment award must be accounted for as modifications. The new guidance will reduce diversity in practice and result in fewer changes to the terms of an award being accounted for as modifications. Under ASU

2017

09,

an entity will

not

apply modification accounting to a share-based payment award if the award’s fair value, vesting conditions and classification as an equity or liability instrument are the same immediately before and after the change. ASU

2017

will be applied prospectively to awards modified on or after the adoption date. The guidance is effective for annual periods, and interim periods within those annual periods, beginning after

December 15, 2017.

Early adoption is permitted. The Company is evaluating the impact of the adoption of this guidance on its financial statements but does

not

expect it to have a material impact.

Cash and Cash Equivalents, Policy [Policy Text Block]

Cash and Cash Equivalents

The Company considers all highly liquid investments with maturities of

days or less from the purchase date to be cash equivalents. Cash and cash equivalents are held in depository and money market accounts and are reported at fair value.

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

year. There have been

realized gains and losses for the years ended

December 31, 2017,

2016

and

2015.

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

other-than-temporary declines in value of short-term investments for the years ended

December 31, 2017,

2016

and

2015,

as it is more likely than

not

the Company will hold the securities until maturity or a recovery of the cost basis.

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

exceed federally insured limits. The Company has

not

experienced any credit losses in such accounts and does

not

believe it is exposed to any significant credit risk on these funds. The Company has

financial instruments with off-balance sheet risk of loss.

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

improve or extend the lives of the respective assets are expensed to operations as incurred. Upon disposal, the related cost and accumulated depreciation is removed from the accounts and any resulting gain or loss is included in the results of operations. Depreciation is recorded using the straight-line method over the estimated useful lives of the respective assets, which are as follows:

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

(“ASC

718”

). ASC

718

requires all stock-based payments to employees, including grants of employee stock options and restricted stock, to be recognized in the consolidated statements of operations and comprehensive loss based on their grant date fair values. Compensation expense related to awards to employees is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term. Share-based payments issued to non-employees are recorded at their fair values and are periodically revalued as the equity instruments vest and are recognized as expense over the related service period in accordance with the provisions of ASC

718

and FASB ASC Topic

505,

Equity

and are expensed using an accelerated attribution model.

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. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Due to the lack of Company specific historical option activity, the Company has estimated the expected term of its employee stock options using the “simplified” method, whereby, the expected term equals the arithmetic average of the vesting term and the original contractual term of the option. The expected term for non-employee awards is the remaining contractual term of the option. The risk-free interest rates are based on the U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The Company has never paid and does

not

expect to pay dividends in the foreseeable future. Refer to Note

“

Use of Estimates

,” for a discussion of the Company's estimated fair value of its Common Stock.

Income Tax, Policy [Policy Text Block]

Income Taxes

Income taxes are recorded in accordance with FASB ASC Topic

740,

“Income Taxes” (“ASC

740”

), which provides for deferred taxes using an asset and liability approach. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax reporting basis of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Valuation allowances are provided if based upon the weight of available evidence, it is more likely than

not

that some or all of the deferred tax assets will

not

be realized. The Company has evaluated available evidence and concluded that the Company

may

not

realize the benefit of its deferred tax assets; therefore, a valuation allowance has been established for the full amount of the deferred tax assets.

The Company accounts for uncertain tax positions in accordance with the provisions of ASC

740.

When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than

not

be realized. The determination as to whether the tax benefit will more likely than

not

be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. As of

December 31, 2017

and

2016,

the Company did

not

have any significant uncertain tax positions. The Company's practice is to recognize interest and/or penalties related to income tax matters in income tax expense. See Note

for further details.

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

-class method when computing net income (loss) per share in periods when issued shares that meet the definition of participating securities are outstanding. The

two

-class method determines net income (loss) per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The

two

-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. Accordingly, in periods in which the Company reports a net loss attributable to common stockholders when participating securities are outstanding, losses are

not

allocated to the participating securities. For purposes of calculating diluted net income per share attributable to common shareholders, preferred stock, stock options, warrants and convertible debt are considered common stock equivalents.

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, 2017

to ensure that this filing includes appropriate disclosure of events both recognized in the consolidated financial statements as of

December 31, 2017

and events which occurred subsequently but were

not

recognized in the consolidated financial statements.