INSPYR THERAPEUTICS, INC., 10-Q filed on 18 Nov 16
Document And Entity Information
9 Months Ended
Sep. 30, 2016
Nov. 18, 2016
Document Information [Line Items]
 
 
Document Type
10-Q 
 
Amendment Flag
false 
 
Document Period End Date
Sep. 30, 2016 
 
Document Fiscal Year Focus
2016 
 
Document Fiscal Period Focus
Q3 
 
Entity Registrant Name
Inspyr Therapeutics, Inc. 
 
Entity Central Index Key
0001421204 
 
Current Fiscal Year End Date
--12-31 
 
Entity Filer Category
Smaller Reporting Company 
 
Trading Symbol
NSPX 
 
Entity Common Stock, Shares Outstanding
 
1,397,705 
CONDENSED BALANCE SHEETS (USD $)
In Thousands, unless otherwise specified
Sep. 30, 2016
Dec. 31, 2015
Current assets:
 
 
Cash and cash equivalents
$ 330 
$ 2,465 
Prepaid expenses
131 
114 
Total current assets
461 
2,579 
Office equipment, net of accumulated depreciation of $0 and $27
12 
Intangible assets, net of accumulated amortization of $140 and $128
72 
84 
Other assets
Total assets
540 
2,678 
Current liabilities:
 
 
Accounts payable
1,097 
977 
Accrued expenses
2,726 
2,432 
Derivative liability
756 
1,177 
Total current liabilities
4,579 
4,586 
Total liabilities
4,579 
4,586 
Commitments and contingencies
   
   
Stockholders’ deficit:
 
 
Convertible preferred stock, par value $.0001 per share; 30,000,000 shares authorized, 1,853 issued and outstanding, respectively
Common stock, par value $0.0001 per share; 150,000,000 shares authorized, 1,392,079 shares issued and outstanding, respectively
Additional paid-in capital
43,426 
43,356 
Accumulated deficit
(47,466)
(45,265)
Total stockholders’ deficit
(4,039)
(1,908)
Total liabilities and stockholders’ deficit
$ 540 
$ 2,678 
CONDENSED BALANCE SHEETS [Parenthetical] (USD $)
In Thousands, except Share data, unless otherwise specified
Sep. 30, 2016
Dec. 31, 2015
Office equipment, accumulated depreciation (in dollars)
$ 0 
$ 27 
Intangible assets, accumulated amortization (in dollars)
$ 140 
$ 128 
Preferred stock, par value (in dollars per share)
$ 0.0001 
$ 0.0001 
Preferred stock, shares authorized
30,000,000 
30,000,000 
Preferred stock, shares issued
1,853 
1,853 
Preferred stock, shares outstanding
1,853 
1,853 
Common stock, par value (in dollars per share)
$ 0.0001 
$ 0.0001 
Common stock, shares authorized
150,000,000 
150,000,000 
Common stock, shares issued
1,392,079 
1,392,079 
Common stock, shares outstanding
1,392,079 
1,392,079 
CONDENSED STATEMENTS OF OPERATIONS (USD $)
In Thousands, except Share data, unless otherwise specified
3 Months Ended 9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Sep. 30, 2016
Sep. 30, 2015
Research and development
$ 379 
$ 459 
$ 1,025 
$ 1,885 
General and administrative
509 
915 
1,600 
2,864 
Total operating expenses
888 
1,374 
2,625 
4,749 
Loss from operations
(888)
(1,374)
(2,625)
(4,749)
Gain (loss) on change in fair value of derivative liability
(334)
421 
Interest income (expense), net
Loss before provision for income taxes
(1,221)
(1,373)
(2,201)
(4,749)
Provision for income taxes
Net loss
$ (1,221)
$ (1,373)
$ (2,201)
$ (4,749)
Net loss per common share, basic and diluted
$ (0.88)
$ (1.12)
$ (1.58)
$ (4.12)
Weighted average shares outstanding
1,392,079 
1,228,542 
1,392,079 
1,152,308 
CONDENSED STATEMENT OF STOCKHOLDERS' DEFICIT (USD $)
In Thousands, except Share data
Total
Convertible Preferred Stock [Member]
Common Stock
Additional Paid-in Capital
Accumulated Deficit
Balance at Dec. 31, 2015
$ (1,908)
$ 0 
$ 1 
$ 43,356 
$ (45,265)
Balance (in shares) at Dec. 31, 2015
 
1,853 
1,392,079 
 
 
Stock-based compensation
70 
70 
Net loss
(2,201)
(2,201)
Balance at Sep. 30, 2016
$ (4,039)
$ 0 
$ 1 
$ 43,426 
$ (47,466)
Balance (in shares) at Sep. 30, 2016
 
1,853 
1,392,079 
 
 
CONDENSED STATEMENTS OF CASH FLOWS (USD $)
In Thousands, unless otherwise specified
9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Cash flows from operating activities:
 
 
Net loss
$ (2,201)
$ (4,749)
Adjustments to reconcile net loss to net cash used in operating activities:
 
 
Depreciation and amortization
16 
15 
Stock-based compensation
70 
265 
Loss on sale of assets
Gain on change in fair value of derivative liability
(421)
Decrease (increase) in operating assets:
 
 
Prepaid expenses
(17)
70 
Increase (decrease) in operating liabilities:
 
 
Accounts payable and accrued expenses
414 
779 
Cash used in operating activities
(2,135)
(3,620)
Cash flows from investing activities:
 
 
Proceeds from sale of assets
 
Acquisition of office equipment
(4)
(4)
Cash used in investing activities
(4)
Cash flows from financing activities:
 
 
Proceeds from sale of common stock and warrants sold
2,514 
Cost of common stock and warrants sold
(253)
Proceeds from exercise of warrants
287 
Cash provided by financing activities
2,548 
Net decrease in cash
(2,135)
(1,076)
Cash and cash equivalents, beginning of period
2,465 
2,316 
Cash and cash equivalents, end of period
$ 330 
$ 1,240 
BACKGROUND
Nature of Operations [Text Block]
NOTE 1 – BACKGROUND
 
Inspyr Therapeutics, Inc. (“we”, “us”, “our company”, “our”, “Inspyr” or the “Company”) was formed under the laws of the State of Delaware in November 2003, and has its principal office in Westlake Village, California. We are an early-stage, pre-revenue, pharmaceutical company focused on the discovery and development of prodrug cancer therapeutics for the treatment of solid tumors, including brain, liver, prostate and other cancers. We plan to develop a series of therapies based on our target-activated prodrug technology platform.
 
Effective August 1, 2016, pursuant to a certificate of amendment to our amended and restated certificate of incorporation, we changed our corporate name from GenSpera, Inc. to Inspyr Therapeutics, Inc. Effective August 1, 2016, our common stock ceased trading under the symbol “GNSZ” and began trading under the symbol NSPX on August 2, 2016.
 
Effective November 4, 2016 at 5:00 p.m. Eastern Time, we effected a one (1) for thirty (30) reverse stock split of our common stock. Accordingly, each of our shareholders received one (1) new share of common stock for every thirty (30) shares of common stock such shareholder held immediately prior to the effective time of the reverse split. The reverse stock split affected all of our issued and outstanding shares of common stock as well as the number of shares of common stock underlying stock options, warrants and other exercisable or convertible instruments outstanding at the effective time of the reverse split. The reverse split also has the effect of proportionately increasing the applicable conversion or exercise price of such convertible securities. The shareholders received no fractional shares and instead had every fractional share rounded up to the next whole number.
 
All references to common stock, share and per share amounts have been retroactively restated to reflect the 1:30 reverse stock split as if it had taken place as of the beginning of the earliest period presented.
 
Our primary focus at the present time is the clinical development of our lead compound, mipsagargin (formerly referred to as G-202), a novel therapeutic agent with a unique mechanism of action. We have completed a Phase 1a/1b dose escalation, safety, tolerability and dose refinement study of mipsagargin, in which we treated a total of 44 patients, including two patients with hepatocellular carcinoma (HCC), or liver cancer, who experienced prolonged stabilization of disease of up to eleven months after initiation of treatment.
 
In addition, we have completed an open label single arm Phase II clinical trial of mipsagargin in subjects with liver cancer, in which twenty-five patients were treated. In May 2015, we received a final clinical study report, and consider the results of the study to be positive, with 63% of treated patients having stable disease at two (2) months and a median time to progression of 4.5 months.
 
In the first quarter of 2014, we entered into a collaborative arrangement to conduct a Phase 2 clinical trial entitled, “G-202-004: An Open-Label, Single-Arm, Phase II Study to Evaluate the Efficacy, Safety and CNS Exposure of G-202 in Patients with Recurrent or Progressive Glioblastoma.” In May 2015, we announced that based on preliminary data obtained in the first stage of the trial, we were expanding the trial to a potential 34 patients. In September 2015 we announced interim Phase 2 data from 11 patients with glioblastoma with demonstrated clinical benefit in a subset of patients with high levels of PSMA expression in the primary tumor. As of October 20, 2016, we have treated twenty-six patients in the trial.
 
During the first quarter of 2016, we initiated a Phase II clinical trial pilot study in patients with prostate cancer entitled, “G-202-005: An Open-Label, Single-Arm, Phase II Study to Evaluate the Safety and Activity of G-202 Administered in the Neoadjuvant Setting Followed by Radical Prostatectomy in Patients with Adenocarcinoma of the Prostate”, via a collaborative agreement with a single site in the U.S., in which one patient has been enrolled as of October 20, 2016.
 
During the second quarter of 2016, we initiated a Phase 2 clinical trial pilot study in patients with clear cell renal cell carcinoma entitled, “G-202-006: An Open-Label, Single-Arm, Phase II Study to Evaluate the Safety and Activity of G-202 in Patients with Clear Cell Renal Cell Carcinoma that Expresses PSMA”, via a collaborative agreement with a single site in the U.S. As of October 20, 2016, two patients have been enrolled.
 
While we believe that the data from the completed trials appear promising, the outcome of our ongoing or future trials may ultimately be unsuccessful.
MANAGEMENT'S PLANS TO CONTINUE AS A GOING CONCERN
Management Plans to Continue as Going Concern Disclosure [Text Block]
NOTE 2 – MANAGEMENT’S PLANS TO CONTINUE AS A GOING CONCERN
 
Basis of Presentation
 
We have prepared our financial statements on the basis that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Certain information and note disclosures normally included in annual financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to those rules and regulations, although we believe that the disclosures made are adequate to make the information not misleading. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for fair presentation have been included. We have incurred losses since inception and have an accumulated deficit of $47.5 million as of September 30, 2016. We anticipate incurring additional losses for the foreseeable future until such time, if ever, that we can generate significant sales from our therapeutic product candidates which are currently in development or we enter into cash flow positive business development transactions.
 
To date, we have generated no sales or revenues, have incurred significant losses and expect to incur significant additional losses as we advance mipsagargin through clinical studies. Consequently, our operations are subject to all the risks inherent in the establishment of a pre-revenue business enterprise as well as those risks associated with a company engaged in the research and development of pharmaceutical compounds. 
  
Our cash and cash equivalents balance at September 30, 2016 was $0.3 million, representing 61% of our total assets. Based on our current expected level of operating expenditures, we expect to be able to fund our operations into the fourth quarter of 2016. We will require additional cash to fund and continue our operations beyond that point. This period could be shortened if there are any unanticipated increases in planned spending on development programs or other unforeseen events. We anticipate raising additional funds through collaborative arrangements, licensing agreements, public or private sales of debt or equity securities, or some combination thereof. There is no assurance that any such arrangement will be entered into or that financing will be available when needed in order to allow us to continue our operations, or if available, on terms favorable or acceptable to us.
 
In the event financing is not obtained, we may pursue cost cutting measures as well as explore the sale of selected assets to generate additional funds. If we are required to significantly reduce operating expenses and delay, reduce the scope of, or eliminate any of our development programs or clinical trials, these events could have a material adverse effect on: our business, results of operations, and financial condition. These factors raise significant doubt about our ability to continue as a going concern. The financial statements do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.
 
Our auditors’ report issued in connection with our December 31, 2015 financial statements expressed an opinion that our capital resources as of the date of their audit report were not sufficient to sustain operations or complete our planned activities for the upcoming year unless we raised additional funds. Accordingly, our current cash level raises substantial doubt about our ability to continue as a going concern past December 2016. If we do not obtain additional funds by such time, we may no longer be able to continue as a going concern and will cease operation which means that our shareholders will lose their entire investment.
SUMMARY OF CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES
Significant Accounting Policies [Text Block]
NOTE 3 – SUMMARY OF CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES
 
Use of estimates
 
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying disclosures. Actual results may differ from those estimates.
 
Research and Development
 
Research and development costs are charged to expense as incurred. Our research and development expenses consist primarily of expenditures for manufacturing, clinical trials, employee compensation and consulting costs and expenses.
 
We incurred research and development expenses of approximately $0.4 million and $0.5 million for the three months ended September 30, 2016 and 2015, respectively. We incurred research and development expenses of approximately $1.0 million and $1.9 million for the nine months ended September 30, 2016 and 2015, respectively.
 
Loss per Share
 
Basic loss per share is calculated by dividing net loss and net loss attributable to common shareholders by the weighted average number of common shares outstanding for the period. Basic and diluted loss per share are the same, in that any potential common stock equivalents would have the effect of being anti-dilutive in the computation of net loss per share. The following potentially dilutive securities have been excluded from the computations of weighted average shares outstanding as of September 30, 2016 and 2015, as they would be anti-dilutive:
  
 
 
Nine months ended September 30,
 
 
 
2016
 
2015
 
Shares underlying options outstanding
 
 
265,863
 
 
297,390
 
Shares underlying warrants outstanding
 
 
1,335,466
 
 
867,319
 
Shares underlying convertible preferred stock outstanding
 
 
411,806
 
 
-
 
Shares underlying convertible notes outstanding
 
 
-
 
 
9,231
 
 
 
 
2,013,135
 
 
1,173,940
 
 
Derivative Liability
 
The Company has financial instruments that are considered derivatives or contain embedded features subject to derivative accounting. Embedded derivatives are valued separately from the host instrument and are recognized as derivative liabilities in the Company’s balance sheet. The Company measures these instruments at their estimated fair value and recognizes changes in their estimated fair value in results of operations during the period of change. Based upon ASC 840-15-25 (EITF Issue 00-19, paragraph 11) the Company has adopted a sequencing approach regarding the application of ASC 815-40 to its outstanding preferred stock.
 
Pursuant to the sequencing approach, the Company evaluates its contracts based upon earliest issuance date wherein instruments with the earliest issuance date would be settled first. The sequencing policy also considers contingently issuable additional shares, such as those issuable upon a stock split, to have an issuance date to coincide with the event giving rise to the additional shares. Using this sequencing policy, all instruments convertible into common stock, including warrants and the conversion feature of notes payable, issued subsequent to December 25, 2015 are classified as derivative liabilities. The Company values these derivative liabilities using the Black-Scholes option pricing model. The resulting liability is valued at each reporting date and the change in the liability is reflected as change in derivative liability in the statement of operations.
 
Fair Value of Financial Instruments
 
Our short-term financial instruments, including cash, accounts payable and other liabilities, consist primarily of instruments with maturities of three months or less when acquired. We believe that the fair values of our current assets and current liabilities approximate their reported carrying amounts.
 
The derivative liability consists of our convertible preferred stock with anti-dilution provisions, and related warrants. The Company uses the Black-Scholes option pricing model to value its derivative liability which incorporate the Company’s stock price, volatility, U.S. risk-free interest rate, dividend rate, and estimated life.
 
Fair Value Measurements
 
Valuation Hierarchy - GAAP establishes a valuation hierarchy for disclosure of the inputs to valuation used to measure fair value. This hierarchy prioritizes the inputs into three broad levels as follows:
 
Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level 2: Quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.
Level 3: Unobservable inputs based on our own assumptions used to measure assets and liabilities at fair value.
 
A financial asset or liability’s classification within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement. The Company has recorded a derivative liability for convertible preferred stock with anti-dilution provisions, and related warrants, as of September 30, 2016. The table below summarizes the fair values of our financial liabilities as of September 30, 2016 (in thousands):
 
 
 
Fair Value at
 
Fair Value Measurement Using
 
 
 
September 30,
2016
 
Level 1
 
Level 2
 
Level 3
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Derivative liability
 
$
756
 
$
 
$
 
$
756
 
 
The reconciliation of the derivative liability measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows (in thousands):
 
 
 
September 30, 2016
 
Balance at beginning of year
 
$
1,177
 
Additions to derivative instruments
 
 
 
Gain on change in fair value of derivative liability
 
 
(421)
 
Balance at end of year
 
$
756
 
 
Stock-Based Compensation
 
We measure the cost of employee services received in exchange for equity awards based on the grant-date fair value of the awards. All awards under our stock-based compensation programs are accounted for at fair value and that cost is recognized over the period during which an employee is required to provide service in exchange for the award (the vesting period).
 
Compensation expense for options granted to non-employees is determined in accordance with the fair value of the consideration received or the fair value of the equity instruments issued, whichever is a more reliable measurement. Compensation expense for awards granted to non-employees is re-measured on each accounting period.
 
Determining the appropriate fair value of stock-based compensation requires the input of subjective assumptions, including the expected life of the stock-based compensation grant/award and the volatility of our stock price. We use the Black-Scholes option-pricing model to value our stock option awards which incorporates our stock price, volatility, U.S. risk-free interest rate, dividend rate, and estimated life.
 
Recent Accounting Pronouncements
 
In March 2016, the Financial Accounting Standards Board (FASB) issued FASB Accounting Standards Update (ASU) 2016-09, “Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting”. The amendments in this update simplify several aspects of the accounting for share-based payment transactions, including income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. This ASU is effective for annual periods beginning after December 15, 2016, and interim periods within those annual periods. We are currently evaluating the effect that the adoption of this standard will have on our financial statements.
 
In February 2016, the FASB issued FASB ASU 2016-02, “Leases (Topic 842)”. The core principle of Topic 842 is that a lessee should recognize the assets and liabilities that arise from leases. For operating leases, a lessee would be required to recognize a right-of-use asset and a lease liability, initially measured at the present value of the lease payments, in the statement of financial position. For leases with a term of 12 months or less, a lessee is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and lease liabilities. The accounting applied by a lessor is largely unchanged from that applied under previous GAAP. This ASU is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. We are currently evaluating the effect that the adoption of this ASU will have on our financial statements.
 
In August 2014, the FASB issued Accounting Standards Update ASU 2014-15 “Presentation of Financial Statements Going Concern (Subtopic 205-40) – Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern”. This update provides guidance about management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern or to provide related footnote disclosures. The amendments require management to assess an entity’s ability to continue as a going concern by incorporating and expanding upon certain principles that are currently in U.S. auditing standards. The amendments contained in this update are effective for public and nonpublic entities for annual periods ending after December 15, 2016. We are currently assessing the impact of the adoption of ASU 2014-15, and we have not yet determined the effect of the standard on our ongoing financial reporting.
 
There are various other recently issued updates, most of which represented technical corrections to the accounting literature or application to specific industries, and are not expected to have a material impact on the Company’s financial position, results of operations or cash flows.
SUPPLEMENTAL CASH FLOW INFORMATION
Cash Flow, Supplemental Disclosures [Text Block]
NOTE 4 – SUPPLEMENTAL CASH FLOW INFORMATION
 
There was no cash paid for interest and income taxes for the nine months ended September 30, 2016 and 2015.
ACCRUED EXPENSES
Accounts Payable and Accrued Liabilities Disclosure [Text Block]
NOTE 5 – ACCRUED EXPENSES
 
Accrued expenses consist of the following (in thousands):
 
 
 
September 30, 2016
 
December 31, 2015
 
Accrued compensation and benefits
 
$
2,438
 
$
2,134
 
Accrued research and development
 
 
129
 
 
152
 
Accrued other
 
 
159
 
 
146
 
Total accrued expenses
 
$
2,726
 
$
2,432
 
DERIVATIVE LIABILITY
Derivative Instruments and Hedging Activities Disclosure [Text Block]
NOTE 6 – DERIVATIVE LIABILITY
 
We account for equity-linked financial instruments, such as our convertible preferred stock, and our common stock warrants as either equity instruments or derivative liabilities depending on the specific terms of the respective agreement. Equity-linked financial instruments are accounted for as derivative liabilities, in accordance with ASC Topic 815 – Derivatives and Hedging, if the instrument allows for cash settlement or provide for modification of the exercise price in the event subsequent sales of our common stock are at a lower price per share than the then-current warrant exercise price. Additionally, financial instruments are classified as derivative liabilities if, as a result of the anti-dilution protection, there is no limit on the number of shares that may be subsequently issued and we conclude there are not adequate authorized shares available to provide for subsequent issuances. We classify derivative liabilities on the balance sheet at fair value, and changes in fair value during the periods presented in the statement of operations, which is revalued at each balance sheet date subsequent to the initial issuance of the stock warrant.
 
In December 2015, we issued shares of convertible preferred stock which contain anti-dilution protection for subsequent equity sales which occur within 18 months, and related warrants. As a result, the Company assessed its outstanding equity-linked financial instruments and concluded that this series of preferred stock, and related warrants, is subject to derivative accounting. The fair value of these shares is classified as a liability in the financial statements, with the change in fair value during the periods presented recorded in the statement of operations.
 
During the nine months ended September 30, 2016, we recorded a gain of $0.4 million related to the change in fair value of the derivative liability during the period. For purpose of determining the fair market value of the derivative liability, the Company used the Black Scholes option pricing model. The significant assumptions used in the Black Scholes valuation of the derivative are as follows:
 
 
 
2016
 
Volatility
 
 
85
%
Expected term (years)
 
 
10 months
 
Risk-free interest rate
 
 
0.64
%
Dividend yield
 
 
None
 
 
As of September 30, 2016, the derivative liability recognized in the financial statements was approximately $0.8 million.
COMMITMENTS AND CONTINGENCIES
Commitments and Contingencies Disclosure [Text Block]
NOTE 7 – COMMITMENTS AND CONTINGENCIES
 
On March 16, 2016, Dr. Craig Dionne provided us his notice of termination as the company’s Chief Executive Officer and Chief Financial Officer. Dr. Dionne’s notice of termination alleges that such termination was for “Good Reason” as a result of a purported material change in his authority, functions, duties and responsibilities as chief executive officer. In the event that termination was for “Good Reason”, Dr. Dionne would be entitled to certain severance payments as well as other benefits. His notice of termination, in addition to requesting such severance, also requests the payment of Dr. Dionne’s annual and long term bonus for 2014 and 2015. On April 11, 2016, we received a letter from Dr. Dionne demanding approximately $2.3 million as a result of the foregoing.
 
The Company vigorously disputes that the termination of his employment was for “Good Reason,” as that term is defined in his employment agreement and under applicable law. This matter is at the early stages. While no litigation is pending at this time, there can be no assurance that this matter will be resolved in such a manner as to avoid litigation. Accordingly, the Company is unable at this time to predict the outcome of this matter, and any views formed as to the viability of these claims or the costs to the Company which could result from these claims may change from time to time as the matter proceeds through its course.
CAPITAL STOCK AND STOCKHOLDER'S EQUITY
Stockholders' Equity Note Disclosure [Text Block]
NOTE 8 – CAPITAL STOCK AND STOCKHOLDER’S EQUITY
 
Common Stock
 
In September 2015, our board of directors approved amending our certificate of incorporation to effect a reverse stock split, subject to shareholder approval, at a ratio of not less than one-for-two (1 for 2), and not more than one-for thirty (1 for 30) at the discretion of the board. On November 15, 2015, our shareholders approved the reverse stock split at the discretion of the board. Effective November 4, 2016 at 5:00 p.m. Eastern Time, the Company’s board of directors effected a one (1) for thirty (30) reverse stock split.
 
During the nine months ended September 30, 2016, no warrants were exercised into common shares. During the nine months ended September 30, 2015, 11,239 warrants were exercised into an equivalent number of common shares for which we received approximately $287,000 in proceeds.
STOCK OPTIONS
Disclosure of Compensation Related Costs, Share-based Payments [Text Block]
NOTE 9 – STOCK OPTIONS
 
Our 2009 Executive Compensation Plan (“2009 Plan”) and our 2007 Equity Compensation Plan (“2007 Plan”) each allow for the issuance of up to 6,000,000 shares of common stock, or 12,000,000 in the aggregate. Collectively, the 2009 Plan and 2007 Plan are referred to as “the Plans.”
 
On July 17, 2016, our board of directors adopted the GenSpera, Inc. Inducement Award Stock Option Plan. The plan is to be used in connection with the recruiting and inducement of senior management and employees. We did not seek approval of the plan by our stockholders. Pursuant to the plan, we may grant stock options for up to a total of 9,000,000 shares of common stock to new employees.
 
Total stock-based compensation expense recognized for stock options issued using the straight-line method in the statement of operations for the nine months ended September 30, 2016 and 2015 was as follows:
 
 
 
Nine months ended September 30,
 
 
 
2016
 
2015
 
 
 
 
 
 
 
 
 
Research and development
 
$
21
 
$
28
 
General and administrative
 
 
49
 
 
73
 
 
 
$
70
 
$
101
 
 
The following table summarizes stock option activity under the Plans:
 
 
 
 
 
 
Weighted-
 
Weighted-average
 
Aggregate
 
 
 
 
 
 
average
 
remaining
 
intrinsic
 
 
 
Number of
 
exercise
 
contractual term
 
value (in
 
 
 
shares
 
price
 
(in years)
 
thousands)
 
Outstanding at December 31, 2015
 
 
292,140
 
$
48.00
 
 
 
 
 
 
 
Granted
 
 
121,759
 
$
4.50
 
 
 
 
 
 
 
Expired
 
 
(32,500)
 
$
47.10
 
 
 
 
 
 
 
Forfeited
 
 
(115,536)
 
$
52.20
 
 
 
 
 
 
 
Outstanding at September 30, 2016
 
 
265,863
 
$
26.40
 
 
5.3
 
$
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exercisable at September 30, 2016
 
 
154,384
 
$
42.00
 
 
2.2
 
$
 
 
As of September 30, 2016, there was approximately $199,000 of total unrecognized compensation cost related to non-vested stock options which vest over a weighted-average period of approximately 1.5 years. As of September 30, 2016, there was no unrecognized compensation expense related to performance-based, non-vested employee stock options.
 
During the nine months ended September 30, 2016, we issued options to purchase 5,300 shares of common stock to non-employee directors under the Plans pursuant to our non-employee director compensation policy. We also issued options to purchase 104,626 shares of common stock to employees. Additionally, we issued options to purchase 11,833 shares of common stock to consultants and advisors. During the nine months ended September 30, 2015, we issued options to purchase 5,300 shares of common stock to non-employee directors, respectively, under the Plans pursuant to our non-employee director compensation policy. Additionally, we issued options to purchase 7,253 shares of common stock to consultants and advisors. The weighted-average fair value of the options granted during 2016 and 2015 was estimated at $2.10 and $9.60 per share, respectively, on the date of grant. During the nine months ended September 30, 2016 and 2015, no options were exercised.
 
On August 2, 2016, and August 8, 2016, respectively, we entered into employment agreements with Christopher Lowe and Ronald Shazer to serve as our chief executive officer and chief medical officer, respectively. In conjunction with the employment agreement of Christopher Lowe, we issued Mr. Lowe 72,155 common stock purchase options. The options have a term of 7 years, an exercise price of $4.35 per share and (i) 18,039 shares vest monthly over a 12-month period and (ii) the remaining 54,116 shares vest upon achievements of certain milestones and time. In conjunction with the employment agreement of Ronald Shazer, we issued Dr. Shazer 32,470 common stock purchase options. The options have a term of 7 years, an exercise price of $4.50 per share and (i) 8,118 shares vest monthly over a 12-month period and (ii) the remaining 24,352 shares vest upon achievements of certain milestones and time. Both options were granted pursuant to our Inducement Award Stock Option Plan.
 
The following table summarizes weighted-average assumptions using the Black-Scholes option-pricing model used on the date of the grants issued during the nine months ended September 30, 2016 and 2015:
 
 
 
Nine months ended September 30,
 
 
 
2016
 
2015
 
Volatility
 
 
90.9
%
 
58.4
%
Expected term (years)
 
 
1.9
 
 
3.4
 
Risk-free interest rate
 
 
0.76
%
 
1.0
%
Dividend yield
 
 
0
%
 
0
%
WARRANTS
Derivatives and Fair Value [Text Block]
NOTE 10 – WARRANTS
 
In December 2015, in connection with a private placement of our securities, we issued an aggregate of 682,845 common stock purchase warrants, including 649,901 to investors; and 32,944 to placement agents. The warrants were issued with an exercise price of $9.00 per share. The Company assessed these outstanding equity-linked financial instruments and concluded that the warrants are subject to derivative accounting (see Note 6). Transactions involving our equity-classified warrants are summarized as follows:
 
 
 
Number of
shares
 
Weighted-
average
exercise
price
 
Weighted-
average
remaining 
contractual
term (in years)
 
Aggregate
intrinsic
value (in
thousands)
 
Outstanding at December 31, 2015
 
 
1,409,248
 
$
23.70
 
 
 
 
 
 
 
Forfeited
 
 
(73,782)
 
$
96.90
 
 
 
 
 
 
 
Outstanding at September 30, 2016
 
 
1,335,466
 
$
19.80
 
 
2.1
 
$
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exercisable at September 30, 2016
 
 
1,335,466
 
$
19.80
 
 
2.1
 
$
 
 
During the nine months ended September 30, 2016, no warrants were exercised. During the nine months ended September 30, 2015, 11,239 warrants were exercised into an equivalent number of common shares for which we received approximately $287,000 in proceeds. The following table summarizes outstanding common stock purchase warrants as of September 30, 2016:
 
 
 
Number of
shares
 
Weighted-
average
exercise
price
 
Expiration
 
 
 
 
 
 
 
 
 
 
 
Issued to consultants
 
 
27,200
 
$
40.20
 
December 2016 through November 2020
 
Issued pursuant to 2012 financings
 
 
9,879
 
$
90.00
 
December 2017
 
Issued pursuant to 2013 financings
 
 
145,874
 
$
59.10
 
December 2017 through August 2018
 
Issued pursuant to 2014 financings
 
 
362,756
 
$
24.60
 
December 2016 through June 2019
 
Issued pursuant to 2014 financings
 
 
789,757
 
$
8.70
 
January 2017 through December 2020
 
 
 
 
1,335,466
 
 
19.80
 
 
 
 
During the nine months ended September 30, 2016, no warrants were issued to consultants. During the nine months ended September 30, 2015, we issued warrants to consultants to purchase 7,500 shares of common stock as compensation for business and advisory services. The common stock purchase warrants have an exercise price of $19.50 per share, are immediately exercisable and expire on the five-year anniversary of the date of issuance. The per share weighted-average fair value of the warrants granted to consultants during 2015 was estimated at $9.00 per share on the date of grant.
 
Total stock-based compensation expense of approximately $0 and $67,000 was recognized for warrants and included in the statement of operations for the nine months ended September 30, 2016 and 2015, respectively.
 
The following table summarizes weighted-average assumptions using the Black-Scholes option-pricing model used on the date of the grants issued during the nine months ended September 30, 2015:
 
 
 
 
 
 
 
 
 
Volatility
 
72.7
%
Expected term (years)
 
1.7
 
Risk-free interest rate
 
0.6
%
Dividend yield
 
0
%
SUBSEQUENT EVENTS
Subsequent Events [Text Block]
NOTE 11 – SUBSEQUENT EVENTS
 
 On October 1, 2016 we entered into an employment agreement with Michael Elliot to serve as our vice president of clinical operations. In conjunction with the employment agreement, we issued Mr. Elliot 18,039 common stock purchase options. The options have a term of 7 years, an exercise price of $4.20 per share and (i) 4,510 shares vest monthly over a 12-month period and (ii) the remaining 13,529 shares vest upon achievements of certain milestones and time. The options were granted pursuant to our Inducement Award Stock Option Plan.
 
On October 12, 2016 and October 13, 2016, respectively, in connection with the appointment of Claire M. Thom and Richard E. Buller, M.D. Ph.D to our Board of Directors, we granted each of them 2,500 common stock purchase options. The options vest on the first year anniversary of the grants. The options have a term of 5 years and exercise prices of $3.90 and $4.05 per share, respectively. The options both vest fully on November 1, 2017 provided their continued services to the Company. The options were issued as compensation for Board services to be performed in accordance with Company’s amended non-executive Board compensation policy and were granted pursuant to our 2007 Equity Compensation Plan.
 
Effective November 4, 2016 at 5:00 p.m. Eastern Time, we effected a one (1) for thirty (30) reverse stock split of our common stock. Accordingly, each of our shareholders received one (1) new share of common stock for every thirty (30) shares of common stock such shareholder held immediately prior to the effective time of the reverse split. The reverse stock split affected all of our issued and outstanding shares of common stock as well as the number of shares of common stock underlying stock options, warrants and other exercisable or convertible instruments outstanding at the effective time of the reverse split.The reverse split also has the effect of proportionately increasing the applicable conversion or exercise price of such convertible securities. The shareholders received no fractional shares and instead had every fractional share rounded up to the next whole number.
 
On November 10, 2016, the Company issued 5,556 common shares to a shareholder pursuant to the conversion of 25.00005 shares of Series A 0% Convertible Preferred Stock at a conversion price of $4.50 per common share.
SUMMARY OF CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES (Policies)
Use of estimates
 
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying disclosures. Actual results may differ from those estimates.
Research and Development
 
Research and development costs are charged to expense as incurred. Our research and development expenses consist primarily of expenditures for manufacturing, clinical trials, employee compensation and consulting costs and expenses.
 
We incurred research and development expenses of approximately $0.4 million and $0.5 million for the three months ended September 30, 2016 and 2015, respectively. We incurred research and development expenses of approximately $1.0 million and $1.9 million for the nine months ended September 30, 2016 and 2015, respectively.
Loss per Share
 
Basic loss per share is calculated by dividing net loss and net loss attributable to common shareholders by the weighted average number of common shares outstanding for the period. Basic and diluted loss per share are the same, in that any potential common stock equivalents would have the effect of being anti-dilutive in the computation of net loss per share. The following potentially dilutive securities have been excluded from the computations of weighted average shares outstanding as of September 30, 2016 and 2015, as they would be anti-dilutive:
  
 
 
Nine months ended September 30,
 
 
 
2016
 
2015
 
Shares underlying options outstanding
 
 
265,863
 
 
297,390
 
Shares underlying warrants outstanding
 
 
1,335,466
 
 
867,319
 
Shares underlying convertible preferred stock outstanding
 
 
411,806
 
 
-
 
Shares underlying convertible notes outstanding
 
 
-
 
 
9,231
 
 
 
 
2,013,135
 
 
1,173,940
 
Derivative Liability
 
The Company has financial instruments that are considered derivatives or contain embedded features subject to derivative accounting. Embedded derivatives are valued separately from the host instrument and are recognized as derivative liabilities in the Company’s balance sheet. The Company measures these instruments at their estimated fair value and recognizes changes in their estimated fair value in results of operations during the period of change. Based upon ASC 840-15-25 (EITF Issue 00-19, paragraph 11) the Company has adopted a sequencing approach regarding the application of ASC 815-40 to its outstanding preferred stock.
 
Pursuant to the sequencing approach, the Company evaluates its contracts based upon earliest issuance date wherein instruments with the earliest issuance date would be settled first. The sequencing policy also considers contingently issuable additional shares, such as those issuable upon a stock split, to have an issuance date to coincide with the event giving rise to the additional shares. Using this sequencing policy, all instruments convertible into common stock, including warrants and the conversion feature of notes payable, issued subsequent to December 25, 2015 are classified as derivative liabilities. The Company values these derivative liabilities using the Black-Scholes option pricing model. The resulting liability is valued at each reporting date and the change in the liability is reflected as change in derivative liability in the statement of operations.
Fair Value of Financial Instruments
 
Our short-term financial instruments, including cash, accounts payable and other liabilities, consist primarily of instruments with maturities of three months or less when acquired. We believe that the fair values of our current assets and current liabilities approximate their reported carrying amounts.
 
The derivative liability consists of our convertible preferred stock with anti-dilution provisions, and related warrants. The Company uses the Black-Scholes option pricing model to value its derivative liability which incorporate the Company’s stock price, volatility, U.S. risk-free interest rate, dividend rate, and estimated life.
Fair Value Measurements
 
Valuation Hierarchy - GAAP establishes a valuation hierarchy for disclosure of the inputs to valuation used to measure fair value. This hierarchy prioritizes the inputs into three broad levels as follows:
 
Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level 2: Quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.
Level 3: Unobservable inputs based on our own assumptions used to measure assets and liabilities at fair value.
 
A financial asset or liability’s classification within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement. The Company has recorded a derivative liability for convertible preferred stock with anti-dilution provisions, and related warrants, as of September 30, 2016. The table below summarizes the fair values of our financial liabilities as of September 30, 2016 (in thousands):
 
 
 
Fair Value at
 
Fair Value Measurement Using
 
 
 
September 30,
2016
 
Level 1
 
Level 2
 
Level 3
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Derivative liability
 
$
756
 
$
 
$
 
$
756
 
 
The reconciliation of the derivative liability measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows (in thousands):
 
 
 
September 30, 2016
 
Balance at beginning of year
 
$
1,177
 
Additions to derivative instruments
 
 
 
Gain on change in fair value of derivative liability
 
 
(421)
 
Balance at end of year
 
$
756
 
Stock-Based Compensation
 
We measure the cost of employee services received in exchange for equity awards based on the grant-date fair value of the awards. All awards under our stock-based compensation programs are accounted for at fair value and that cost is recognized over the period during which an employee is required to provide service in exchange for the award (the vesting period).
 
Compensation expense for options granted to non-employees is determined in accordance with the fair value of the consideration received or the fair value of the equity instruments issued, whichever is a more reliable measurement. Compensation expense for awards granted to non-employees is re-measured on each accounting period.
 
Determining the appropriate fair value of stock-based compensation requires the input of subjective assumptions, including the expected life of the stock-based compensation grant/award and the volatility of our stock price. We use the Black-Scholes option-pricing model to value our stock option awards which incorporates our stock price, volatility, U.S. risk-free interest rate, dividend rate, and estimated life.
Recent Accounting Pronouncements
 
In March 2016, the Financial Accounting Standards Board (FASB) issued FASB Accounting Standards Update (ASU) 2016-09, “Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting”. The amendments in this update simplify several aspects of the accounting for share-based payment transactions, including income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. This ASU is effective for annual periods beginning after December 15, 2016, and interim periods within those annual periods. We are currently evaluating the effect that the adoption of this standard will have on our financial statements.
 
In February 2016, the FASB issued FASB ASU 2016-02, “Leases (Topic 842)”. The core principle of Topic 842 is that a lessee should recognize the assets and liabilities that arise from leases. For operating leases, a lessee would be required to recognize a right-of-use asset and a lease liability, initially measured at the present value of the lease payments, in the statement of financial position. For leases with a term of 12 months or less, a lessee is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and lease liabilities. The accounting applied by a lessor is largely unchanged from that applied under previous GAAP. This ASU is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. We are currently evaluating the effect that the adoption of this ASU will have on our financial statements.
 
In August 2014, the FASB issued Accounting Standards Update ASU 2014-15 “Presentation of Financial Statements Going Concern (Subtopic 205-40) – Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern”. This update provides guidance about management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern or to provide related footnote disclosures. The amendments require management to assess an entity’s ability to continue as a going concern by incorporating and expanding upon certain principles that are currently in U.S. auditing standards. The amendments contained in this update are effective for public and nonpublic entities for annual periods ending after December 15, 2016. We are currently assessing the impact of the adoption of ASU 2014-15, and we have not yet determined the effect of the standard on our ongoing financial reporting.
 
There are various other recently issued updates, most of which represented technical corrections to the accounting literature or application to specific industries, and are not expected to have a material impact on the Company’s financial position, results of operations or cash flows.
SUMMARY OF CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES (Tables)
The following potentially dilutive securities have been excluded from the computations of weighted average shares outstanding as of September 30, 2016 and 2015, as they would be anti-dilutive:
  
 
 
Nine months ended September 30,
 
 
 
2016
 
2015
 
Shares underlying options outstanding
 
 
265,863
 
 
297,390
 
Shares underlying warrants outstanding
 
 
1,335,466
 
 
867,319
 
Shares underlying convertible preferred stock outstanding
 
 
411,806
 
 
-
 
Shares underlying convertible notes outstanding
 
 
-
 
 
9,231
 
 
 
 
2,013,135
 
 
1,173,940
 
The table below summarizes the fair values of our financial liabilities as of September 30, 2016 (in thousands):
 
 
 
Fair Value at
 
Fair Value Measurement Using
 
 
 
September 30,
2016
 
Level 1
 
Level 2
 
Level 3
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Derivative liability
 
$
756
 
$
 
$
 
$
756
 
The reconciliation of the derivative liability measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows (in thousands):
 
 
 
September 30, 2016
 
Balance at beginning of year
 
$
1,177
 
Additions to derivative instruments
 
 
 
Gain on change in fair value of derivative liability
 
 
(421)
 
Balance at end of year
 
$
756
 
ACCRUED EXPENSES (Tables)
Schedule of Accrued Liabilities [Table Text Block]
Accrued expenses consist of the following (in thousands):
 
 
 
September 30, 2016
 
December 31, 2015
 
Accrued compensation and benefits
 
$
2,438
 
$
2,134
 
Accrued research and development
 
 
129
 
 
152
 
Accrued other
 
 
159
 
 
146
 
Total accrued expenses
 
$
2,726
 
$
2,432
 
DERIVATIVE LIABILITY (Tables)
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Table Text Block]
The significant assumptions used in the Black Scholes valuation of the derivative are as follows:
 
 
 
2016
 
Volatility
 
 
85
%
Expected term (years)
 
 
10 months
 
Risk-free interest rate
 
 
0.64
%
Dividend yield
 
 
None
 
STOCK OPTIONS (Tables)
Total stock-based compensation expense recognized for stock options issued using the straight-line method in the statement of operations for the nine months ended September 30, 2016 and 2015 was as follows:
 
 
 
Nine months ended September 30,
 
 
 
2016
 
2015
 
 
 
 
 
 
 
 
 
Research and development
 
$
21
 
$
28
 
General and administrative
 
 
49
 
 
73
 
 
 
$
70
 
$
101
 
The following table summarizes stock option activity under the Plans:
 
 
 
 
 
 
Weighted-
 
Weighted-average
 
Aggregate
 
 
 
 
 
 
average
 
remaining
 
intrinsic
 
 
 
Number of
 
exercise
 
contractual term
 
value (in
 
 
 
shares
 
price
 
(in years)
 
thousands)
 
Outstanding at December 31, 2015
 
 
292,140
 
$
48.00
 
 
 
 
 
 
 
Granted
 
 
121,759
 
$
4.50
 
 
 
 
 
 
 
Expired
 
 
(32,500)
 
$
47.10
 
 
 
 
 
 
 
Forfeited
 
 
(115,536)
 
$
52.20
 
 
 
 
 
 
 
Outstanding at September 30, 2016
 
 
265,863
 
$
26.40
 
 
5.3
 
$
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exercisable at September 30, 2016
 
 
154,384
 
$
42.00
 
 
2.2
 
$
 
The following table summarizes weighted-average assumptions using the Black-Scholes option-pricing model used on the date of the grants issued during the nine months ended September 30, 2016 and 2015:
 
 
 
Nine months ended September 30,
 
 
 
2016
 
2015
 
Volatility
 
 
90.9
%
 
58.4
%
Expected term (years)
 
 
1.9
 
 
3.4
 
Risk-free interest rate
 
 
0.76
%
 
1.0
%
Dividend yield
 
 
0
%
 
0
%
WARRANTS (Tables)
The Company assessed these outstanding equity-linked financial instruments and concluded that the warrants are subject to derivative accounting (see Note 6). Transactions involving our equity-classified warrants are summarized as follows:
 
 
 
Number of
shares
 
Weighted-
average
exercise
price
 
Weighted-
average
remaining 
contractual
term (in years)
 
Aggregate
intrinsic
value (in
thousands)
 
Outstanding at December 31, 2015
 
 
1,409,248
 
$
23.70
 
 
 
 
 
 
 
Forfeited
 
 
(73,782)
 
$
96.90
 
 
 
 
 
 
 
Outstanding at September 30, 2016
 
 
1,335,466
 
$
19.80
 
 
2.1
 
$
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exercisable at September 30, 2016
 
 
1,335,466
 
$
19.80
 
 
2.1
 
$
 
The following table summarizes outstanding common stock purchase warrants as of September 30, 2016:
 
 
 
Number of
shares
 
Weighted-
average
exercise
price
 
Expiration
 
 
 
 
 
 
 
 
 
 
 
Issued to consultants
 
 
27,200
 
$
40.20
 
December 2016 through November 2020
 
Issued pursuant to 2012 financings
 
 
9,879
 
$
90.00
 
December 2017
 
Issued pursuant to 2013 financings
 
 
145,874
 
$
59.10
 
December 2017 through August 2018
 
Issued pursuant to 2014 financings
 
 
362,756
 
$
24.60
 
December 2016 through June 2019
 
Issued pursuant to 2014 financings
 
 
789,757
 
$
8.70
 
January 2017 through December 2020
 
 
 
 
1,335,466
 
 
19.80
 
 
 
The following table summarizes weighted-average assumptions using the Black-Scholes option-pricing model used on the date of the grants issued during the nine months ended September 30, 2015:
 
 
 
 
 
 
 
 
 
Volatility
 
72.7
%
Expected term (years)
 
1.7
 
Risk-free interest rate
 
0.6
%
Dividend yield
 
0
%
MANAGEMENT'S PLANS TO CONTINUE AS A GOING CONCERN (Details Textual) (USD $)
In Thousands, unless otherwise specified
Sep. 30, 2016
Dec. 31, 2015
Sep. 30, 2015
Dec. 31, 2014
Management Plan [Line Items]
 
 
 
 
Deficit accumulated during the development stage
$ (47,466)
$ (45,265)
 
 
Cash and Cash Equivalents, at Carrying Value
$ 330 
$ 2,465 
$ 1,240 
$ 2,316 
Percentage of Cash and Cash Equivalents in Total Assets
61.00% 
 
 
 
SUMMARY OF CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES (Details)
9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
 
 
Shares underlying, outstanding
2,013,135 
1,173,940 
Convertible Notes Payable [Member]
 
 
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
 
 
Shares underlying, outstanding
9,231 
Convertible Preferred Stock [Member]
 
 
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
 
 
Shares underlying, outstanding
411,806 
Warrant [Member]
 
 
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
 
 
Shares underlying, outstanding
1,335,466 
867,319 
Employee Stock Option [Member]
 
 
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
 
 
Shares underlying, outstanding
265,863 
297,390 
SUMMARY OF CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES (Details 1) (USD $)
In Thousands, unless otherwise specified
Sep. 30, 2016
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
 
Derivative liability
$ 756 
Fair Value, Inputs, Level 1 [Member]
 
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
 
Derivative liability
Fair Value, Inputs, Level 2 [Member]
 
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
 
Derivative liability
Fair Value, Inputs, Level 3 [Member]
 
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
 
Derivative liability
$ 756 
SUMMARY OF CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES (Details 2) (USD $)
In Thousands, unless otherwise specified
9 Months Ended
Sep. 30, 2016
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
 
Balance at beginning of year
$ 1,177 
Additions to derivative instruments
Gain on change in fair value of derivative liability
(421)
Balance at end of year
$ 756 
SUMMARY OF CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES (Details Textual) (USD $)
In Thousands, unless otherwise specified
3 Months Ended 9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Sep. 30, 2016
Sep. 30, 2015
Summary Of Critical Accounting Policies [Line Items]
 
 
 
 
Research and Development Expense, Total
$ 379 
$ 459 
$ 1,025 
$ 1,885 
ACCRUED EXPENSES (Details) (USD $)
In Thousands, unless otherwise specified
Sep. 30, 2016
Dec. 31, 2015
Accrued Expenses [Line Items]
 
 
Accrued compensation and benefits
$ 2,438 
$ 2,134 
Accrued research and development
129 
152 
Accrued other
159 
146 
Total accrued expenses
$ 2,726 
$ 2,432 
DERIVATIVE LIABILITY (Details)
9 Months Ended
Sep. 30, 2016
Volatility
85.00% 
Expected term (years)
10 months 
Risk-free interest rate
0.64% 
Dividend yield
0.00% 
DERIVATIVE LIABILITY (Details Textual) (USD $)
9 Months Ended
Sep. 30, 2016
Derivative, Gain on Derivative
$ 400,000 
Derivative Liability
$ 756,000 
COMMITMENTS AND CONTINGENCIES (Details Textual) (USD $)
In Millions, unless otherwise specified
0 Months Ended
Apr. 11, 2016
Commitments And Contingencies [Line Items]
 
Loss Contingency, Damages Sought, Value
$ 2.3 
CAPITAL STOCK AND STOCKHOLDER'S EQUITY (Details Textual) (USD $)
In Thousands, except Share data, unless otherwise specified
9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Class of Stock [Line Items]
 
 
Number of Warrants Exercised
 
11,239 
Proceeds from Warrant Exercises
$ 0 
$ 287 
Common Stock [Member]
 
 
Class of Stock [Line Items]
 
 
Number of Warrants Exercised
 
11,239 
STOCK OPTIONS (Details) (USD $)
In Thousands, unless otherwise specified
9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
 
 
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost
$ 70 
$ 101 
Research and development [Member]
 
 
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
 
 
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost
21 
28 
General and administrative [Member]
 
 
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
 
 
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost
$ 49 
$ 73 
STOCK OPTIONS (Details 1) (USD $)
In Thousands, except Share data, unless otherwise specified
9 Months Ended
Sep. 30, 2016
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
 
Number of shares, Outstanding at beginning of period (in shares)
292,140 
Number of shares, Granted (in shares)
121,759 
Number of shares, Expired (in shares)
(32,500)
Number of shares, Forfeited (in shares)
(115,536)
Number of shares, Outstanding at end of period (in shares)
265,863 
Number of shares, Exercisable (in shares)
154,384 
Weighted-average exercise price, Outstanding at beginning of period (in dollars per share)
$ 48.00 
Weighted-average exercise price, Granted (in dollars per share)
$ 4.50 
Weighted-average exercise price, Expired (in dollars per share)
$ 47.10 
Weighted-average exercise price, Forfeited (in dollars per share)
$ 52.20 
Weighted-average exercise price, Outstanding at end of period (in dollars per share)
$ 26.40 
Weighted-average exercise price, Exercisable (in dollars per share)
$ 42.00 
Weighted-average remaining contractual term, Outstanding
5 years 3 months 18 days 
Weighted-average remaining contractual term, Exercisable
2 years 2 months 12 days 
Aggregate intrinsic value, Outstanding (in dollars)
$ 0 
Aggregate intrinsic value, Exercisable (in dollars)
$ 0 
STOCK OPTIONS (Details 2)
9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
 
 
Expected term (years)
1 year 8 months 12 days 
 
Risk-free interest rate
0.60% 
 
Dividend yield
0.00% 
 
Employee Stock Option [Member]
 
 
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
 
 
Volatility
90.90% 
58.40% 
Expected term (years)
1 year 10 months 24 days 
3 years 4 months 24 days 
Risk-free interest rate
0.76% 
1.00% 
Dividend yield
0.00% 
0.00% 
STOCK OPTIONS (Details Textual) (USD $)
9 Months Ended 0 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Sep. 30, 2016
Employee Stock Option [Member]
Aug. 2, 2016
Chief Executive Officer [Member]
Employee Stock Option [Member]
Aug. 8, 2016
Chief Medical Officer [Member]
Employee Stock Option [Member]
Sep. 30, 2016
Plan 2009 [Member]
Sep. 30, 2016
Plan 2007 [Member]
Jul. 17, 2016
GenSpera, Inc. Inducement Award Stock Option Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
 
 
 
 
 
 
 
 
Employee Service Share-based Compensation, Nonvested Awards, Total Compensation Cost Not yet Recognized, Stock Options
$ 199,000 
 
 
 
 
 
 
 
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized
 
 
 
 
 
6,000,000 
12,000,000 
9,000,000 
Share Based Compensation Arrangement Options Issued To Non Employee Directors
5,300 
5,300 
 
 
 
 
 
 
Share Based Compensation Arrangement Options Issued To Consultants
11,833 
7,253 
 
 
 
 
 
 
Share Based Compensation Arrangement Options Issued To Consultants Weighted Average Price
$ 2.10 
$ 9.60 
 
 
 
 
 
 
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights
 
 
 
(i) 18,039 shares vest monthly over a 12-month period and (ii) the remaining 54,116 shares vest upon achievements of certain milestones and time. 
(i) 8,118 shares vest monthly over a 12-month period and (ii) the remaining 24,352 shares vest upon achievements of certain milestones and time. 
 
 
 
Deferred Compensation Arrangement with Individual, Maximum Contractual Term
 
 
 
7 years 
7 years 
 
 
 
Deferred Compensation Arrangement with Individual, Exercise Price
 
 
 
$ 4.35 
$ 4.50 
 
 
 
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period
1 year 6 months 
 
 
 
 
 
 
 
Share-Based Compensation Arrangement By Share-Based Payment Award, Options, Grants In Period, Gross
121,759 
 
104,626 
72,155 
32,470 
 
 
 
WARRANTS (Details) (Warrant [Member], USD $)
In Thousands, except Share data, unless otherwise specified
9 Months Ended
Sep. 30, 2016
Warrant [Member]
 
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
 
Number of shares, Outstanding at beginning of period (in shares)
1,409,248 
Number of shares, Forfeited (in shares)
(73,782)
Number of shares, Outstanding at ending of period (in shares)
1,335,466 
Number of shares, Exercisable (in shares)
1,335,466 
Weighted-average exercise price, Outstanding at beginning of period (in dollars per share)
$ 23.70 
Weighted-average exercise price, Forfeited (in dollars per share)
$ 96.90 
Weighted-average exercise price, Outstanding at end of period (in dollars per share)
$ 19.80 
Weighted-average exercise price, Exercisable (in dollars per share)
$ 19.80 
Weighted-average remaining contractual term, Outstanding
2 years 1 month 6 days 
Weighted-average remaining contractual term, Exercisable
2 years 1 month 6 days 
Aggregate intrinsic value, Outstanding (in dollars)
$ 0 
Aggregate intrinsic value, Exercisable (in dollars)
$ 0 
WARRANTS (Details 1) (USD $)
9 Months Ended
Sep. 30, 2016
Equity-classified warrants [Abstract]
 
Number of shares (in shares)
1,335,466 
Weighted Average Exercise price (in dollars per share)
$ 19.80 
Equity Classified Warrants [Member] |
Consultant [Member]
 
Equity-classified warrants [Abstract]
 
Number of shares (in shares)
27,200 
Weighted Average Exercise price (in dollars per share)
$ 40.20 
Investment Warrants Expiration Date Range Start
Dec. 31, 2016 
Investment Warrants Expiration Date Range End
Nov. 30, 2020 
Equity Classified Warrants [Member] |
Financing 2012 [Member]
 
Equity-classified warrants [Abstract]
 
Number of shares (in shares)
9,879 
Weighted Average Exercise price (in dollars per share)
$ 90.00 
Investment Warrants Expiration Date
Dec. 31, 2017 
Equity Classified Warrants [Member] |
Financing 2013 [Member]
 
Equity-classified warrants [Abstract]
 
Number of shares (in shares)
145,874 
Weighted Average Exercise price (in dollars per share)
$ 59.10 
Investment Warrants Expiration Date Range Start
Dec. 31, 2017 
Investment Warrants Expiration Date Range End
Aug. 31, 2018 
Equity Classified Warrants [Member] |
Financing 2014 [Member]
 
Equity-classified warrants [Abstract]
 
Number of shares (in shares)
362,756 
Weighted Average Exercise price (in dollars per share)
$ 24.60 
Investment Warrants Expiration Date Range Start
Dec. 31, 2016 
Investment Warrants Expiration Date Range End
Jun. 30, 2019 
Equity Classified Warrants [Member] |
Financing 2014 [Member]
 
Equity-classified warrants [Abstract]
 
Number of shares (in shares)
789,757 
Weighted Average Exercise price (in dollars per share)
$ 8.70 
Equity Classified Warrants [Member] |
Financing 2014 [Member]
 
Equity-classified warrants [Abstract]
 
Investment Warrants Expiration Date Range Start
Jan. 31, 2017 
Investment Warrants Expiration Date
Dec. 31, 2020 
WARRANTS (Details 2)
9 Months Ended
Sep. 30, 2016
Derivative Instruments and Hedging Activities Disclosures [Line Items]
 
Volatility
72.70% 
Expected term (years)
1 year 8 months 12 days 
Risk-free interest rate
0.60% 
Dividend yield
0.00% 
WARRANTS (Details Textual) (USD $)
9 Months Ended 12 Months Ended 12 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Sep. 30, 2016
Warrant [Member]
Sep. 30, 2015
Warrant [Member]
Sep. 30, 2015
Business And Advisory Services [Member]
Dec. 31, 2015
Consultants [Member]
Sep. 30, 2015
Consultants [Member]
Dec. 31, 2015
Placement Agent [Member]
Dec. 31, 2015
Investor [Member]
Dec. 31, 2015
Equity Classified Warrants [Member]
Minimum [Member]
Warrants And Derivative Warrant Liability [Line Items]
 
 
 
 
 
 
 
 
 
 
Warrants Exercised
 
11,239 
 
 
 
 
 
 
 
 
Class of Warrant or Right, Exercise Price of Warrants or Rights
$ 19.80 
 
 
$ 19.50 
 
 
$ 9.00 
 
 
$ 9.00 
Proceeds from Warrant Exercises
$ 0 
$ 287,000 
 
 
 
 
 
 
 
 
Warrants Issued to Consultants, Shares
 
 
 
 
7,500 
 
 
 
 
 
Share-based Compensation, Total
$ 70,000 
$ 265,000 
$ 0 
$ 67,000 
 
 
 
 
 
 
Warrants Issued
 
 
 
 
 
682,845 
 
32,944 
649,901 
 
SUBSEQUENT EVENTS (Details Textual) (USD $)
9 Months Ended 0 Months Ended 1 Months Ended
Sep. 30, 2016
Nov. 10, 2016
Subsequent Event [Member]
Oct. 31, 2016
Subsequent Event [Member]
Michael Elliot [Member]
Oct. 31, 2016
Subsequent Event [Member]
M. Thom [Member]
Oct. 31, 2016
Subsequent Event [Member]
Richard E. Buller [Member]
Subsequent Event [Line Items]
 
 
 
 
 
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants , Weighted Average Contractual Term
 
 
7 years 
5 years 
5 years 
Share Based Compensation Arrangement By Share Based Payment Award,Options,Vesting ,Description
 
 
4,510 shares vest monthly over a 12-month period and (ii) the remaining 13,529 shares vest upon achievements of certain milestones and time. 
 
 
Share-Based Compensation Arrangement By Share-Based Payment Award, Options, Grants In Period, Gross
121,759 
 
18,039 
2,500 
2,500 
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price
$ 4.50 
 
$ 4.20 
$ 3.90 
$ 4.05 
Stock Conversion Conversion Price Per Share
 
$ 4.50 
 
 
 
Conversion of Stock, Shares Issued
 
5,556 
 
 
 
Conversion of Stock, Shares Converted
 
25.00005 
 
 
 
Preferred Stock, Dividend Rate, Percentage
 
0.00% 
 
 
 

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