INSPYR THERAPEUTICS, INC., 10-K filed on 17 Apr 17
Document and Entity Information (USD $)
In Thousands, except Share data, unless otherwise specified
12 Months Ended
Dec. 31, 2016
Mar. 31, 2017
Document And Entity Information
 
 
Entity Registrant Name
Inspyr Therapeutics, Inc. 
 
Entity Central Index Key
0001421204 
 
Document Type
10-K 
 
Trading Symbol
NSPX 
 
Document Period End Date
Dec. 31, 2016 
 
Amendment Flag
false 
 
Current Fiscal Year End Date
--12-31 
 
Entity a Well-known Seasoned Issuer
No 
 
Entity a Voluntary Filer
No 
 
Entity's Reporting Status Current
Yes 
 
Entity Filer Category
Smaller Reporting Company 
 
Entity Public Float
$ 134,206 
 
Entity Common Stock, Shares Outstanding
 
1,532,417 
Document Fiscal Period Focus
FY 
 
Document Fiscal Year Focus
2016 
 
BALANCE SHEETS (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2016
Dec. 31, 2015
Current assets:
 
 
Cash and cash equivalents
$ 547 
$ 2,465 
Prepaid expenses
112 
114 
Total current assets
659 
2,579 
Office equipment, net of accumulated depreciation of $0 and $27
12 
Intangible assets, net of accumulated amortization of $144 and $128
68 
84 
Other assets
Total assets
734 
2,678 
Current liabilities:
 
 
Accounts payable
1,238 
977 
Accrued expenses
384 
2,432 
Derivative liability
2,541 
1,177 
Total current liabilities
4,163 
4,586 
Total liabilities
4,163 
4,586 
Stockholders' deficit:
 
 
Convertible preferred stock, par value $.0001 per share; 30,000,000 shares authorized, 2,828 and 1,853 shares issued and outstanding, respectively
   
   
Common stock, par value $.0001 per share; 150,000,000 shares authorized, 1,398,832 and 1,392,079 shares issued and outstanding, respectively
   
   
Additional paid-in capital
45,391 
43,357 
Accumulated deficit
(48,820)
(45,265)
Total stockholders' deficit
(3,429)
(1,908)
Total liabilities and stockholders' deficit
$ 734 
$ 2,678 
BALANCE SHEETS (Parenthetical) (USD $)
In Thousands, except Share data, unless otherwise specified
Dec. 31, 2016
Dec. 31, 2015
Statement of Financial Position [Abstract]
 
 
Office equipment, accumulated depreciation (in dollars)
$ 0 
$ 27 
Intangible assets, accumulated amortization (in dollars)
$ 144 
$ 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
2,828 
1,853 
Preferred stock, shares outstanding
2,828 
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
1,398,832 
1,392,079 
Common stock, shares outstanding
1,398,832 
1,392,079 
STATEMENTS OF LOSSES (USD $)
In Thousands, except Share data, unless otherwise specified
12 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Operating expenses:
 
 
Research and development
$ 1,101 
$ 2,303 
General and administrative
2,089 
3,764 
Total operating expenses
3,190 
6,067 
Loss from operations
(3,190)
(6,067)
Other income (expense):
 
 
Gain on change in fair value of derivative liability
2,523 
181 
Interest income (expense), net
(2,888)
   
Loss before provision for income taxes
(3,555)
(5,886)
Provision for income taxes
   
   
Net loss
$ (3,555)
$ (5,886)
Net loss per common share, basic and diluted (in dollars per share)
$ (2.55)
$ (4.99)
Weighted average shares outstanding (in shares)
1,394,065 
1,179,278 
STATEMENT OF STOCKHOLDERS' DEFICIT (USD $)
In Thousands, except Share data, unless otherwise specified
Convertible Preferred Stock [Member]
Common Stock [Member]
Additional Paid-in Capital [Member]
Accumulated Deficit [Member]
Total
Balance at beginning at Dec. 31, 2014
    
    
$ 39,476 
$ (39,379)
$ 97 
Balance at beginning (in shares) at Dec. 31, 2014
   
1,106,040 
 
 
 
Increase (Decrease) in Stockholders' Equity [Roll Forward]
 
 
 
 
 
Stock-based compensation
   
   
138 
   
138 
Reversal of prior year accrued officer compensation
 
 
 
 
   
Common stock and warrants issued as payment of services and consulting fees
 
   
175 
   
175 
Common stock and warrants issued as payment of services and consulting fees (in shares)
 
4,257 
 
 
 
Common stock issued upon conversion of note payable
 
   
139 
   
139 
Common stock issued upon conversion of note payable (in shares)
 
8,750 
 
 
 
Sale of common stock and warrants at $21.00 per share
 
   
2,514 
   
2,514 
Sale of common stock and warrants at $21.00 per share (in shares)
 
119,709 
 
 
 
Exercise of warrants
 
   
926 
   
926 
Exercise of warrants (in shares)
 
153,323 
 
 
 
Sale of preferred stock and warrants at $4.50 and $0.75 per share
   
   
1,853 
   
1,853 
Sale of preferred stock and warrants at $4.50 and $0.75 per share (in shares)
1,853 
 
 
 
 
Issuance cost of sales of common stock and warrants
 
   
(506)
   
(506)
Derivative liability
 
   
(1,358)
   
(1,358)
Net loss
 
   
   
(5,886)
(5,886)
Balance at end at Dec. 31, 2015
 
   
43,357 
(45,265)
(1,908)
Balance at end (in shares) at Dec. 31, 2015
1,853 
1,392,079 
 
 
 
Increase (Decrease) in Stockholders' Equity [Roll Forward]
 
 
 
 
 
Stock-based compensation
 
   
113 
   
113 
Adjustment for reverse split (in shares)
 
1,197 
 
 
 
Conversion of preferred stock
 
   
   
   
   
Conversion of preferred stock (in shares)
(25)
5,556 
 
 
 
Reeclasification of derivative liability
 
   
   
Reversal of prior year accrued officer compensation
 
   
2,053 
   
2,053 
Sale of preferred stock and warrants at $4.50 and $0.75 per share
 
   
900 
   
900 
Sale of preferred stock and warrants at $4.50 and $0.75 per share (in shares)
1,000 
 
 
 
 
Cost of preferred stock sale
 
   
(35)
   
(35)
Derivative liability
 
   
(1,000)
   
(1,000)
Net loss
 
   
   
(3,555)
(3,555)
Balance at end at Dec. 31, 2016
 
    
$ 45,391 
$ (48,820)
$ (3,429)
Balance at end (in shares) at Dec. 31, 2016
2,828 
1,398,832 
 
 
 
STATEMENT OF STOCKHOLDERS' DEFICIT (Parenthetical)
Dec. 31, 2016
Warrants 0.75 [Member]
Dec. 31, 2015
Warrants 21 [Member]
Dec. 31, 2015
Warrants 4.5 [Member]
Shares Issued, Price Per Share
$ 0.75 
$ 21.00 
$ 4.50 
STATEMENTS OF CASH FLOWS (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Cash flows from operating activities:
 
 
Net loss
$ (3,555)
$ (5,886)
Adjustments to reconcile net loss to net cash used in operating activities:
 
 
Depreciation and amortization
21 
21 
Loss on sale of assets
 
Stock-based compensation
113 
313 
Gain on change in fair value of derivative liability
(2,523)
(181)
Finance cost
2,891 
   
Increase in operating assets:
 
 
Prepaid expenses
83 
Increase in operating liabilities:
 
 
Accounts payable and accrued expenses
314 
1,017 
Cash used in operating activities
(2,733)
(4,633)
Cash flows from investing activities:
 
 
Proceeds from sale of office equipment
   
Acquisition of office equipment
(4)
(4)
Cash used in investing activities
   
(4)
Cash flows from financing activities:
 
 
Proceeds from sale of stock and warrants
850 
4,367 
Proceeds from exercise of warrants
   
925 
Cost of common stock and warrants sold
(35)
(506)
Cash provided by financing activities
815 
4,786 
Net (decrease) increase in cash
(1,918)
149 
Cash, beginning of period
2,465 
2,316 
Cash, end of period
$ 547 
$ 2,465 
BACKGROUND
BACKGROUND

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 17, 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. 

 

We are an early-stage, pre-revenue, pharmaceutical company focused on the development of prodrug cancer therapeutics for the treatment of solid tumors. A prodrug is an inactive precursor of a drug that is converted into its active form only at the site of the tumor. Our technology platform combines a powerful cytotoxin with a patented prodrug delivery system that targets the release of the drug within the tumor. We believe our cancer prodrugs have the potential to provide a targeted therapeutic approach to a broad range of solid tumors with fewer side effects than those related to current cytotoxic chemotherapy treatments. Our lead drug candidate, mipsagargin, has completed an open label single arm Phase II clinical trial in patients with advanced hepatocellular carcinoma (HCC) or liver cancer.

 

Our major focus for the next twelve to eighteen months is the (i) development of a clinical protocol for and enrollment into a dose optimization trial of single-agent mipsagargin followed by a clinical trial in patients with advanced HCC, (ii) completion of the non-clinical study of mipsagargin in combination with Nexavar® in liver tumor models (iii) development of a Phase 1b clinical protocol of mipsagargin in combination with Nexavar® in patients with Nexavar® naïve HCC in anticipation of positive non-clinical data, (iv) completion of a nonclinical study of mipsagargin in combination with paclitaxel and in combination with DC101 (Cyramza surrogate antibody) in gastric cancer tumor models, (v) ongoing business development discussions with potential development partners, (vi) evaluation of mipsagargin (single agent and in combination with standard of care) in nonclinical models of other solid tumor types that express PSMA, (vii) evaluate our PSMA-peptide prodrug technology with new linkers and new payloads in non-clinical models, and (viii) explore collaborations utilizing mipsagargin in new, non-clinical solid tumor models with leading researchers in the oncology field.

 

A review of ongoing investigator led clinical trials resulted in the discontinuation of studies to realign with our mipsagargin clinical strategy of prioritizing smaller, fast to market indications, pursuing mipsagargin combinations with standard of care, and conducting key clinical trials as company sponsored studies. Larger market indications will be pursued subsequently. The investigator led studies that were discontinued during the realignment were G202-004 (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), G202-005 (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) and G202-006 (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); all studies were closed December 2016.

 

In January 2015, we presented preliminary results from our Phase II study of mipsagargin in advanced liver cancer patients, and these data were updated in May 2015 when we received a final clinical study report. We consider the results of the study to be positive, with 41% of evaluable patients demonstrating a reduction in tumor burden, 63% of treated patients having stable disease, and a median time to progression of 4.5 months. Additionally, the trial demonstrated that mipsagargin is effective at destroying the vascularity of solid tumors thereby starving the tumor. These results support our plans to continue the development of mipsagargin for patients with liver cancer, as well as proceed with our development strategy in other indications. 

 

While we believe that the data from our nonclinical and completed clinical studies appear promising, the outcome of our ongoing or future studies may ultimately be unsuccessful.

 

Our ability to execute our business plan is dependent on the amount and timing of cash, if any, that we are able to raise. Should we not raise sufficient funds to execute our business plan, our priority is the completion of the nonclinical studies of mipsagargin in HCC and gastric cancer and continuing business development discussions with potential development partners.

MANAGEMENT'S PLANS TO CONTINUE AS A GOING CONCERN
MANAGEMENT'S PLANS TO CONTINUE AS A GOING CONCERN

Note 2 — Management’s Plans to Continue as a Going Concern

  

Basis of Presentation

  

The opinion of our independent registered accounting firm on our financial statements contains explanatory going concern language. 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 $48.8 million as of December 31, 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 December 31, 2016 was $0.5 million, representing 75% of our total assets. Based on our current expected level of operating expenditures, and a financing completed in the first quarter of 2017, we expect to be able to fund our operations into the second quarter of 2017. 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, 2016 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 second quarter of 2017. 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
SUMMARY OF CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES

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. Significant estimates include the fair value of derivative instruments, stock-based compensation, recognition of clinical trial costs and other accrued liabilities. 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 toxicology and other studies, manufacturing, clinical trials, compensation and consulting costs.  

 

We incurred research and development expenses of $1.1 and $2.3 million for the years ended December 31, 2016 and 2015, respectively.

  

Cash Equivalents

 

For purposes of the statements of cash flows, we consider all highly liquid debt instruments purchased with a maturity date of three months or less to be cash equivalents. We maintain our cash in bank deposit accounts which, at times, may exceed applicable government mandate insurance limits. We have not experienced any losses in our accounts.

  

Concentrations of Credit Risk

 

Financial instruments and related items, which potentially subject the Company to concentrations of credit risk, consist primarily of cash and cash equivalents. The Company places its cash and temporary cash investments with credit quality institutions. At times, such investments may exceed applicable government mandated insurance limits. Cash and cash equivalents were $0.5 million and $2.5 million at December 31, 2016 and 2015, respectively. As of December 31, 2016 and 2015, there was approximately $0.3 million and $2.1 million in cash over the federally insured limit, respectively.

  

We currently outsource all manufacturing of our clinical supplies to single source manufactures. We also have a single source supplier for the active ingredient in our prodrug compounds, including mipsagargin. A change in these suppliers could cause a delay in manufacturing and/or clinical trials, which would adversely affect our Company.

  

Intangible Assets

  

Intangible assets consist of licensed technology, patents, and patent applications (see Note 5). The assets associated with licensed technology are recorded at cost and are being amortized on the straight line basis over their estimated useful lives of twelve to seventeen years.

  

Office Equipment

 

Office equipment is stated at cost less accumulated depreciation.  Depreciation is calculated on the straight line basis over the estimated useful lives of the assets of three to five years. Expenditures for repair and maintenance which do not materially extend the useful lives of property and equipment are charged to expense. When property or equipment is sold or otherwise disposed of, the cost and related accumulated depreciation are removed from the respective accounts with the resulting gain or loss reflected in operations. Management periodically reviews the carrying value of its office equipment for impairment.

  

Depreciation expense was approximately $4,000 for each of the years ended December 31, 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 December 31, 2016 and 2015, as they would be anti-dilutive:

  

    Year Ended December 31,  
    2016     2015  
Shares underlying options outstanding     268,876       292,172  
Shares underlying warrants outstanding     5,203,436       1,409,248  
Shares underlying convertible preferred stock outstanding     3,770,833       411,806  
      9,243,145       2,113,226  

 

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 derivative liabilities. The Company values these derivative liabilities using the Black-Scholes option valuation 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

  

The U.S. GAAP Valuation Hierarchy 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 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are 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 inputs are 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 December 31, 2016 and 2015. The tables below summarize the fair values of our financial liabilities as of December 31, 2016 and 2015 (in thousands):

 

    Fair Value at
December 31,
    Fair Value Measurement Using  
    2016     Level 1     Level 2     Level 3  
                         
Derivative liability   $ 2,541     $     $     $ 2,541  

 

    Fair Value at
December 31,
    Fair Value Measurement Using  
    2015     Level 1     Level 2     Level 3  
                         
Derivative liability   $ 1,177     $     $     $ 1,177  

  

The reconciliation of the derivative liability measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows (in thousands):

  

Balance, January 1, 2015   $  
Additions to derivative instruments     1,358  
Loss (gain) on change in fair value of derivative liability     (181 )
Balance, December 31, 2015     1,177  
Additions to derivative instruments     3,890  
Reclassification on conversion     (3 )
Loss (gain) on change in fair value of derivative liability     (2,523 )
Balance, December 31, 2016   $ 2,541  

 

Income Taxes

 

Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income and the reversal of deferred tax liabilities during the period in which the related temporary difference becomes deductible.

  

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 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.

 

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
SUPPLEMENTAL CASH FLOW INFORMATION

NOTE 4 – SUPPLEMENTAL CASH FLOW INFORMATION

 

The following table contains additional information for the periods reported (in thousands).

 

    Year Ended December 31,  
    2016     2015  
Non-cash financial activities:                
Reversal of accrued prior year compensation credited to paid-in capital   $ 2,053     $  
Derivative liability issued     2,845        
Common/Preferred stock and warrants issued for fees     50       175  
Common stock issued on conversion of notes payable           139  

 

There was no cash paid for interest and income taxes for the years ended December 31, 2016 and 2015.

INTELLECTUAL PROPERTY
INTELLECTUAL PROPERTY

NOTE 5 – INTELLECTUAL PROPERTY

 

We solely own or have exclusive licenses to all of our patents and patent applications. Between 2008 and 2011, we entered into license and assignment agreements with Johns Hopkins University (JHU), the University of Copenhagen (UC) and certain co-inventors (Assignee Co-Founders), in which we paid $212,000 in cash and common stock. As a result of these payments and pursuant to the agreements, we acquired worldwide, exclusive, fully paid up rights in know-how, pre-clinical data, development data and certain patent portfolios that relate to, and form the basis of, our technology. Under these agreements, we are not required to make any other future payments, including fees or other reimbursements, milestones, or royalties, to JHU, UC, or the Assignee Co-Founders.

 

Amortization expense recorded during the years ended December 31, 2016 and 2015 was approximately $17,000 for both years. Amortization expense is estimated to be approximately $17,000 for each one of the next four fiscal years.

ACCRUED EXPENSES
ACCRUED EXPENSES

NOTE 6 – ACCRUED EXPENSES

 

Accrued expenses consist of the following (in thousands):

 

    December 31,  
    2016     2015  
             
Accrued compensation and benefits   $ 62     $ 2,134  
Accrued research and development     126       152  
Accrued other     196       146  
Total accrued expenses   $ 384     $ 2,432  

  

During 2016 we have reversed approximately $2 million of prior year accrued bonus compensation. It has been determined that attainment of milestones and goals was not met and that the bonuses have not been earned. The reversal of the prior year accrual has been credited to additional paid in capital.

CONVERTIBLE NOTES PAYABLE
CONVERTIBLE NOTES PAYABLE

NOTE 7 — CONVERTIBLE NOTES PAYABLE

 

We issued convertible notes to our former chief executive officer pursuant to which we borrowed an aggregate of $0.2 million, with an interest rate of 4.2%, and maturities at various dates through December 6, 2011. The notes and accrued interest were convertible, at the option of the holder, into shares of our common stock at a conversion price of $15.00 per share.

 

In October 2015, the board of directors approved amending the conversion price of the convertible notes from a price of $15.00 per share to $12.00 per share, in exchange for our chief executive officer waiving approximately $33,000 of outstanding accrued interest. Accordingly, our former chief executive elected to convert the outstanding notes into 8,750 shares of common stock.

DERIVATIVE LIABILITY
DERIVATIVE LIABILITY

NOTE 8 — 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 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 for a period of 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.

 

In December 2016, we issued additional shares of convertible preferred stock which contain anti-dilution protection and other conversion price adjustment provisions, and related warrants which contain anti-dilution protection and other exercise price adjustment provisions. 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 year ended December 31, 2016, we recorded a gain of approximately $2.5 million related to the change in fair value of the derivative liabilities during the period. For purpose of determining the fair market value of the derivative liability, the Company used Black Scholes option valuation model. The significant assumptions used in the Black Scholes valuations of the derivatives at December 31, 2016 are as follows:

 

    2016
Volatility   97%-215%
Expected term (years)   2 - 60 months
Risk-free interest rate   0.62% -1.93%
Dividend yield   None

  

During the year ended December 31, 2015, we recorded a gain of approximately $0.2 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 Black Scholes option valuation model. The significant assumptions used in the Black Scholes valuations of the derivatives at December 31, 2015 are as follows:

 

    2015
Volatility   84%-85%
Expected term   18 months
Risk-free interest rate   0.75%
Dividend yield   None

 

As of December 31, 2016 and 2015, the derivative liability recognized in the financial statements was approximately $2.5 million and $1.2 million, respectively.

COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES

NOTE 9 — COMMITMENTS AND CONTINGENCIES

 

Operating Leases

 

The Company currently does not have any ongoing leases for office space. It has availability to office space on an as needed basis.  Its employees work on a remote basis. Rent expense for office space amounted to approximately $49,000 and $57,000 for the years ended December 31, 2016 and 2015, respectively.

 

Employment Agreements

 

We employ our Chief Executive Officer, our Chief Operating Officer and our Chief Medical Officer pursuant to written employment agreements. The employment agreements contain severance provisions and indemnification clauses. The indemnification agreement provides for the indemnification and defense of the executive officers, in the event of litigation, to the fullest extent permitted by law.

 

On February 28, 2017, Russell Richerson, PhD, resigned as chief operating officer of the Company, effective immediately. Dr. Richerson entered into a separation release of claims agreement (“Separation Agreement”) pursuant to which the Company: (i) issued Dr. Richerson a warrant to purchase 76,726 shares of Common Stock with an exercise price of $0.75 per share and a term of three and a half (3.5) years, (ii) agreed to make the vested portion of any options held by Dr. Richerson, exercisable at any time during their remaining term regardless of any termination provisions contained in the applicable equity compensation plans pursuant to which such awards were made (collectively, the “Awards”) and (iii) agreed to reduce the exercise prices of such Awards to $0.75 per share for the duration of their respective terms. In consideration of the foregoing, Dr. Richerson agreed to release the Company from any and all claims, including any rights or obligations as contained in his prior employment agreement, as amended.

 

Severance provisions are not applicable to any other executive officer employment agreements until such time as they have each been employed for at least 6 months and the Company has raised $25 million in gross proceeds from capital raising transactions. Severance provisions pursuant to a termination within 12 months of a Sale Event occurring are not applicable as of December 31, 2016, as no Sale Event has occurred prior to such date.

 

Legal Matters

 

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 states that such termination was for “Good Reason” as a result of a 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. The notice of termination, in additional to requesting such severance, also requests the payment of Dr. Dionne’s annual and long term bonus for 2014 and 2015. While the Company disputes that the termination was for “Good Reason,” as well as the amount of the bonuses due Dr. Dionne, if any, at this time the Company is unable to predict the financial outcome of this matter, and any views formed as to the viability of these claims or the financial liability which could result may change from time to time as the matter proceeds through its course. The Company is uncertain whether any litigation may result from the foregoing and the outcome of any such litigation is uncertain.

 

The Company is subject at times to other legal proceedings and claims, which arise in the ordinary course of its business.  Although occasional adverse decisions or settlements may occur, the Company believes that the final disposition of such matters should not have a material adverse effect on its financial position, results of operations or liquidity. 

CAPITAL STOCK AND STOCKHOLDER'S EQUITY
CAPITAL STOCK AND STOCKHOLDER'S EQUITY

NOTE 10 — CAPITAL STOCK AND STOCKHOLDER’S EQUITY

 

Preferred Stock

 

In December 2016, we issued 1,000 shares of our Series B 0% Convertible Preferred Stock, with a stated value of $1,000 per share and the common shares are issuable pursuant to conversion of the preferred stock at a conversion price of $0.75 per share, subject to beneficial ownership limitations and subject to adjustment pursuant to stock splits and dividends, and subject to adjustment pursuant to anti-dilution protection for subsequent equity sales and other conversion price adjustments. See “December 2016 Offering” below for further discussion.

 

In December 2015, we issued 1,853 shares of our Series A 0% Convertible Preferred Stock, with a stated value of $1,000 per share and the common shares are issuable pursuant to conversion of the preferred stock at a conversion price of $4.50 per share, subject to a 9.99% beneficial ownership limitation and subject to adjustment pursuant to stock splits and dividends, and subject to adjustment pursuant to anti-dilution protection for subsequent equity sales for a period of 18 months from the effective date of this registration statement. See “December 2015 Offering” below for further discussion.

 

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.

 

On December 15, 2016, the conversion price of the Series A Preferred Stock was reset to $0.75 per share, resulting from the December 2016 Offering.

 

Common Stock

  

In September 2015, the board of directors approved amending the Company’s certificate of incorporation to effect a reverse stock split, subject to shareholder approval, of the Company’s issued and outstanding common stock at a ratio of not less than one-for-two (1 for 2), and not more than one-for thirty (1 for 30). Accordingly, the company was given the authority to take the action necessary to obtain shareholder approval at the shareholder meeting scheduled to be held on November 13, 2015. At the meeting, the shareholders approved the amendment. 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.

 

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.

 

During 2016 we have reversed approximately $2 million of prior year accrued bonus compensation. It has been determined that attainment of milestones and goals was not met and that the bonuses have not been earned. The reversal of the prior year accrual has been credited to additional paid in capital.

 

In July 2015, we granted an aggregate of 4,167 shares of common stock, valued at approximately $95,000, to a consultant for business advisory services to be provided to the Company. In March 2015, we granted an aggregate of 1,000 shares of common stock, valued at approximately $27,000, to a consultant for business advisory services to be provided to the Company. In August 2015, we cancelled and retired an aggregate of 910 shares of common stock, with a value of approximately $25,000, upon the termination of an agreement for business advisory services.

  

During the year ended December 31, 2015, 11,239 warrants were exercised into an equivalent number of common shares for which we received approximately $287,000 in proceeds. During the year ended December 31, 2016, no warrants were exercised into common shares.

  

Equity Financings

 

December 2016 Offering

 

In December, 2016, we sold $1,000,000 of the Company’s securities consisting of 1,000 shares of Series B 0% Convertible Preferred Stock and an aggregate of 4,000,008 common stock purchase warrants as described below. The Series B Preferred Stock has a stated value of $1,000 and is immediately convertible into 1,333,336 shares of the Company’s common stock, subject to certain beneficial ownership limitations, at a conversion price equal to $0.75, subject to adjustment. The Conversion Price is subject to certain reset adjustments as more fully described in the Certificate of Designation (as defined below), including (a) the date of any future amendment to the Company’s certificate of incorporation with respect to a reverse stock split, (b) the effective dates of the initial registration statement registering the common shares underlying the Series B Preferred Stock as required under the Registration Rights Agreement (defined below) and (c) in certain cases, the six (6) and twelve (12) month anniversaries of the closing of this offering if certain registration and public information requirements are not met. The Series B Preferred Stock also has a liquidation preference ahead of the Company’s common stock and has anti-dilution protection until such time that the Series B Preferred Stock is no longer outstanding.

 

The Investors also received an aggregate of approximately: (i) 1,333,336 Series J common stock purchase warrants (“Series J Warrants”), (ii) 1,333,336 Series K common stock purchase warrants (“Series K Warrants”) and (iii) 1,333,336 Series L common stock purchase warrants (“Series L Warrants”) (collectively, the “Warrants”). The Series J Warrants have an exercise price of $0.90 per share, subject to adjustment, and a term of five (5) years from the date of issuance, the Series K Warrants have an exercise price of $0.75 per share, subject to adjustment, and a term of six (6) months from the date of issuance and the Series L warrants have an exercise price of $0.75, subject to adjustment, and a term of twelve (12) months from the date of issuance. The Warrants are immediately exercisable and separately transferable from the Series B Preferred Stock. In the event that the shares underlying the Warrants are not subject to a registration statement at the time of exercise, the Warrants may be exercised on a cashless basis after 6 months from the issuance date. The exercise price of the Warrants is subject to certain reset adjustments as more fully described in the form of Warrants, including (i) the date of any future amendment to the Company’s certificate of incorporation with respect to a reverse stock split, (ii) the effective dates of the initial registration statement registering the common shares underlying the Warrants as required under the Registration Rights Agreement (defined below) and (iii) in certain cases, the six (6) and twelve (12) month anniversaries of the date of issuance of the Warrants if certain registration and public information requirements are not met. The Warrants also contain provisions providing for an adjustment in the underlying number of shares and exercise price in the event of stock splits or dividends and fundamental transactions. Additionally, the Warrants contain anti-dilution protection until such time that the Warrants are no longer outstanding.

  

In connection with the Offering, the Investors also entered in a registration rights agreement (“Registration Rights Agreement”). Pursuant to the Registration Rights Agreement, the Company agreed to file a registration statement with the Securities and Exchange Commission (“the Commission”) within 30 days from the date of the Registration Rights Agreement to register the resale of 200% of the shares of common stock underlying the Series B Preferred Stock and 100% of the shares of common stock underlying the Warrants and to maintain the effectiveness thereunder. The Company also agreed to have the registration statement declared effective within 60 days from the date of the Registration Rights Agreement and keep the registration statement continuously effective until the earlier of (i) the date after which all of the securities to be registered thereunder have been sold, or (ii) the date on which all the securities to be registered thereunder may be sold without volume or manner-of-sale restrictions and without current public information pursuant to Rule 144 under the Securities Act of 1933, as amended. We are also obligated to pay the Investors, as partial liquidated damages, a fee of 1.5% of each Investor’s subscription amount per month in cash upon the occurrence of certain events, including our failure to file and / or have the registration statement declared effective within the time provided. The registration statement was filed on January 13, 2017 and was declared effective on January 31, 2017

 

Our placement agent for the Offering received an aggregate commission of $100,000 and a non-accountable expense allowance of $10,000 and a management fee of $10,000. The Placement Agent has agreed to take $100,000 worth of compensation in securities, upon the same terms as the Investors are purchasing in the Offering. The Placement Agent also received 133,334 common stock purchase warrants with substantially the same terms as the Series J Warrants (“PA Warrants”). The Placement Agent will also receive a cash fee of 10% of gross proceeds received from the exercise of the Warrants. The Placement Agent shall further have a right of first refusal for a twelve (12) month period to act as lead underwriter, placement agent or manager with respect to a public offering transaction of debt or equity of the Company’s securities.

  

Proceeds from the December 2016 offering consisted of $850,000 in cash and the satisfaction of $150,000 of obligations, including the placement agent commission. 

  

The Investors were additionally given a right of participation in future offerings for a period of up to eighteen (18) months from the date in which the shares underlying the Series B Preferred Stock and Warrants are registered as contemplated in the Registration Rights Agreement. The Securities Purchase Agreement also prohibits the Company from issuing any common stock, subject to certain exemptions, for a period of 90 days following the effectiveness of the registration statement as contemplated in the Registration Rights Agreement without the written approval of the Investors owning at least 51% of the securities issued in the Offering. Additionally, until the twelve (12) month anniversary of such effectiveness of the registration statement, the Company is prohibited from entering into any agreement to effect any issuance of common stock in a variable rate transaction.

 

December 2015 Offering

  

In December 2015, we offered and sold 1,853 shares of our Series A 0% Convertible Preferred Stock and 649,901 common stock purchase warrants to certain accredited investors with whom we had a prior relationship or who were shareholders. From this sale and the exercise of 153,322 outstanding warrants, we received gross proceeds of approximately $2.5 million. The warrants include (i) 205,903 Series F common stock purchase warrants with a price per share of $9.00 and a term of five years from the date in which the shares underlying the warrants are registered, (ii) 205,903 Series G common stock purchase warrants with a price per share of $9.00 and a term of eighteen months from the date in which the shares underlying the warrants are registered, (iii) 119,048 Series H common stock purchase warrants issued pursuant to a contractually obligated exercise of prior outstanding warrants, with a price per share of $9.00 and a term of five years from the issuance date, and (iv) 119,048 Series I common stock purchase warrants issued pursuant to a contractually obligated exercise of prior outstanding warrants, with a price per share of $9.00 and a term of eighteen months from the issuance date. The preferred stock has a stated value of $1,000 per share and the common shares are issuable pursuant to conversion of the preferred stock at a conversion price of $4.50 per share, subject to a 9.99% beneficial ownership limitation and subject to adjustment pursuant to stock splits and dividends, and subject to adjustment pursuant to customary anti-dilution protection for subsequent equity sales for a period of 18 months from the effective date of this registration statement. In connection with the offering, we issued our placement agent 32,944 common stock purchase warrants with substantially the same terms as our Series F warrants, except that they have an expiration date of December 29, 2020.

  

July 2015 Offering

  

In July 2015, we offered and sold 119,709 units, in a private placement to certain accredited investors with whom we had a prior relationship or who were shareholders. Each unit consists of: (i) one share of common stock, (ii) one Series D common stock purchase warrant, and (iii) one Series E common stock purchase warrant. The price was $21.00 per unit, and resulted in gross proceeds of approximately $2.5 million. The Series D warrants have a term of five years and entitle the holder to purchase our common stock at a price per share of $24.00 per share. The Series E warrants have a term of eighteen months and entitle the holder to purchase our common stock at a price per share of $21.00 per share. In the event that the shares underlying the warrants are not subject to a registration statement at the time of exercise, the warrants may be exercised on a cashless basis after 30 days from the issuance date. In connection with the offering, we issued our placement agent 9,577 common stock purchase warrants with substantially the same terms as our Series D warrants.

STOCK OPTIONS
STOCK OPTIONS

NOTE 11 — STOCK OPTIONS

  

Deferred Compensation Plan

  

In July of 2011, we adopted Executive Deferred Compensation Plan (the Deferred Plan). The Deferred Plan is intended to comply with the requirements of Section 409A of the Internal Revenue Code of 1986, as amended (the Code). The Deferred Plan is intended to be an unfunded “top hat” plan which is maintained primarily to provide deferred compensation benefits for a select group of our “management or highly compensated employees” within the meaning of Sections 201, 301, and 401 of the Employee Retirement Income Security Act of 1974, as amended (ERISA), and to therefore be exempt from the provisions of Parts 2, 3, and 4 of Title I of ERISA. The Deferred Plan is intended to help build a supplemental source of savings and retirement income through pre-tax deferrals of eligible compensation, which may include cash, option and stock bonus awards, discretionary cash, option and stock awards and/or any other payments which may be designated by the Deferred Plan administrator, as eligible, for deferral under the Deferred Plan from time to time. As administered, the Deferred Plan is used to defer compensation of stock awards granted under our other equity compensation plans and does not by its terms approve any grants or awards.

 

GenSpera’s Compensation Plans

 

The Company’s 2007 Equity Compensation Plan (2007 Plan), 2009 Executive Compensation Plan (2009 Plan), and the Inducement Award Stock Option Plan (Inducement Plan) (together, the Plans) provide for the awarding of stock grants, nonqualified and incentive stock options, restricted stock units, performance units or other stock-based awards to officers, directors, employees and consultants of the Company. The purpose of the Plans is to advance the interests of GenSpera and our stockholders by attracting, retaining and rewarding persons performing services for us and to motivate such persons to contribute to our growth and profitability. Our Plans are administered by a committee of non-employee directors (the Committee). The Committee determines: who shall be granted awards; the vesting periods; the exercise price; and any other terms deemed appropriate for any award.

  

Our 2007 Plan is administered by our board or any of its committees. The purposes of the 2007 Plan are to attract and retain the best available personnel for positions of substantial responsibility, to provide additional incentive to Employees, Directors and Consultants, and to promote the success of our business. The issuance of awards under our 2007 Plan is at the discretion of the administrator, which has the authority to determine the persons to whom any awards shall be granted and the terms, conditions and restrictions applicable to any award. Under our 2007 Plan, we may grant stock options, restricted stock, stock appreciation rights, restricted stock units, performance units, performance shares and other stock based awards. Our 2007 Plan authorizes the issuance of up to 50,000 shares of common stock for the foregoing awards per fiscal year with an aggregate of 200,000 shares of common stock available for issuance under the 2007 Plan. As of December 31, 2016, we have granted awards under the 2007 Plan equal to approximately 171,862 shares of our common stock, and 61,853 shares have been cancelled or forfeited. Accordingly, there are 89,991 shares of common stock available for future awards under the 2007 Plan. In the event of a change in control, awards under the 2007 Plan will become fully vested unless such awards are assumed or substituted by the successor corporation.

 

Our 2009 Plan, as amended is administered by our Board or any of its committees. The purpose of our 2009 Plan is to advance the interests of the Company and our stockholders by attracting, retaining and rewarding persons performing services for us and to motivate such persons to contribute to our growth and profitability. The issuance of awards under our 2009 Plan is at the discretion of the administrator, which has the authority to determine the persons to whom any awards shall be granted and the terms, conditions and restrictions applicable to any award. Under our 2009 Plan, we may grant stock options, restricted stock, stock appreciation rights, restricted stock units, performance units, performance shares and other stock-based awards. As of December 31, 2016, our 2009 Plan authorizes the issuance of up to 200,000 shares of our common stock for the foregoing awards, and we have granted awards under the plan equal to approximately 164,868 common shares, and 115,782 shares have been cancelled or forfeited. Accordingly, there are 150,914 shares of common stock available for future awards under the 2009 Plan.

 

Our Inducement Plan is administered by our board or our compensation committee. The Plan is intended to be used in connection with the recruiting and inducement of senior management and employees. The issuance of wards under the Inducement Plan is at the discretion of the administrator which has the authority to determine the persons to whom any awards shall be granted and the terms, conditions and restrictions applicable to any award. The Company did not seek approval of the Plan by our stockholders. Pursuant to the Inducement Plan, the Company may grant stock options for up to a total of 300,000 shares of common stock to new employees of the Company. As of December 31, 2016, 115,450 grants have been made pursuant to the Plan.

 

The Company has recorded aggregate stock-based compensation expense related to the issuance of stock option awards in the following line items in the accompanying consolidated statement of losses (in thousands):

 

    Year Ended December 31,  
    2016     2015  
Research and development   $ 41     $ 45  
General and administrative     72       93  
Total stock-based compensation expense   $ 113     $ 138  

 

As of December 31, 2016, there was $186,000 of total unrecognized compensation cost related to non-vested stock options which vest over time, and is expected to be recognized $129,000 in 2017 and $57,000 in 2018. 

 

The following table summarizes stock option activity under the Plans:

 

    Number of
shares
    Weighted-
average
exercise
price
    Weighted-
average
remaining
contractual term
(in years)
    Aggregate
intrinsic
value (in
thousands)
 
                         
Outstanding at December 31, 2014     289,535     $ 48.60                  
Granted     12,553     $ 23.70                  
Exercised                            
Forfeited     (9,916 )   $ 62.40                  
Outstanding at December 31, 2015     292,172     $ 48.00       3.2     $  
Granted     139,253     $ 4.37                  
Forfeited     (162,549 )   $ 49.92                  
Outstanding at December 31, 2016     268,876     $ 24.15       4.6     $  
                                 
Exercisable at December 31, 2016     151,313     $ 39.54       3.1     $  

 

During 2016 and 2015, the Company issued options to purchase 127,417 and 5,300 shares of common stock, respectively, to employees, and non-employee directors under the Plans. The weighted-average fair value of the options granted to employees and non-employee directors during 2016 and 2015 was estimated at $1.93 and $9.00 per share, respectively, on the date of grant.

 

During 2016 and 2015, the Company issued options to purchase 11,836 and 7,253 shares of common stock, respectively, to consultants under the Plan. The per-share weighted-average fair value of the options granted to consultants during 2016 and 2015 was estimated at $2.33 and $10.20, respectively, on the date of grant.

 

The following table summarizes weighted-average assumptions using the Black-Scholes option-pricing model used on the date of the grants issued for the years ended December 31, 2016 and 2015:

 

    Year Ended December 31,  
    2016     2015  
Volatility     90.6 %     58.4 %
Expected term (years)     1.9       3.4  
Risk-free interest rate     0.77 %     1.0 %
Dividend yield     None       None  

 

No options were exercised during the years ended December 31, 2016 and 2015.

WARRANTS
WARRANTS

NOTE 12 — WARRANTS

 

Transactions involving our 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, 2014     663,383     $ 48.30                  
Granted     941,841     $ 8.10                  
Exercised     (153,322 )     5.70                  
Forfeited     (42,535 )   $ 93.60                  
Outstanding at December 31, 2015     1,409,367     $ 23.70       2.8     $ 8.4  
Granted     4,140,557     $ 0.81                  
Exercised     -     $ -                  
Forfeited     (346,488 )   $ 37.89                  
Outstanding at December 31, 2016     5,203,436     $ 4.56       2.25     $ -  
                                 
Exercisable at December 31, 2016     5,196,822     $ 4.56       2.25     $ -  

  

During the year ended December 31, 2016, no warrants were exercised into common shares. During the year ended December 31, 2015, 153,322 warrants were exercised into an equivalent number of common shares for which we received approximately $926,000 in proceeds. 

 

The following table summarizes outstanding warrants to purchase common stock as of December 31, 2016:

 

    Number of
shares
    Weighted
Average
Exercise
price
    Expiration
Issued to consultants     28,087     $ 26.45     June 2017 through August 2023
Issued pursuant to 2013 financings     155,819     $ 61.11     December 2017 through August 2018
Issued pursuant to 2014 financings     96,412     $ 34.50     June 2019
Issued pursuant to 2015 financings     789,776     $ 8.63     January 2017 through January 2021
Issued pursuant to 2016 financings     4,133,342     $ 0.80     June 2017 through December 2021
      5,203,436              

 

During 2016, the Company issued warrants to a consultant to purchase 7,215 common shares at a fair value of $1.89 per share on the date of grant. The common stock purchase warrants have an exercise price of $4.35 per share, vest over a two year period and expire on the seven-year anniversary of the date of issuance. During 2016, total stock-based compensation expense of approximately $1,500 was recognized using the straight-line method in the statement of losses for warrants issued to consultants.

 

During 2015, the Company issued warrants to consultants to purchase 10,000 at a weighted-average fair value of $7.80 per share on the date of grant. The common stock purchase warrants have exercise prices of between $10.50 and $19.50 per share, are immediately exercisable and expire on the five-year anniversary of the date of issuance. During 2015, total stock-based compensation expense of approximately $78,000, was recognized using the straight-line method in the statement of losses for warrants issued to consultants.

 

    Year Ended December 31,  
    2016     2015  
Volatility     77 %     72.6 %
Expected term (years)     6.7       1.8  
Risk-free interest rate     1.87 %     0.6 %
Dividend yield     None       None  

 

In December 2016, in connection with a private placement, we issued an aggregate of 4,133,342 common stock purchase warrants, including 4,000,008 to investors; and 133,334 to placement agents. The warrants were issued with exercise prices of $0.75 - $0.90 per share. The Company assessed these outstanding equity-linked financial instruments and concluded that the warrants are subject to derivative accounting (see Note 8).

 

In December 2015, in connection with a private placement, 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 8).

 

In July 2015, also in connection with a private placement, we issued an aggregate of 248,995 common stock purchase warrants, including 239,419 to investors; and 9,577 to placement agents. The warrants were issued with exercise prices between $21.00 and $24.00 per share.

INCOME TAXES
INCOME TAXES

NOTE 13 — INCOME TAXES

 

The Company had, subject to limitation, $37.6 million of net operating loss carryforwards at December 31, 2016, which will expire at various dates beginning in 2016 through 2026. In addition, the Company has research and development tax credits of approximately $458,000 at December 31, 2016 available to offset future taxable income, which will expire from 2028 through 2036. We have provided a 100% valuation allowance for the deferred tax benefits resulting from the net operating loss carryover and our tax credits due to our lack of earnings history. In addressing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences are deductible. The valuation allowance increased by approximately $1.2 million and $2.0 million for the year ended December 31, 2016 and 2015, respectively. Significant components of deferred tax assets and liabilities are as follows (in thousands):

  

    2016     2015  
Deferred tax assets:                
Net operating loss carryover   $ 12,798     $ 11,066  
Stock-based compensation     3,109       3,768  
Other     75       (60 )
Tax credits     458       456  
Total deferred tax assets     16,440       15,230  
Less: valuation allowance     (16,440 )     (15,230 )
Net deferred tax assets   $     $  

 

The actual tax benefit differs from the expected tax benefit for the years ended December 31, 2016 and 2015 (computed by applying the U.S. Federal Corporate tax rate of 34% to income before taxes) are as follows:

  

    2016     2015  
Statutory federal income tax rate     -34.0 %     -34.0 %
Non-deductible items     0.0 %     0.1 %
Adjustment for R&D Credit     -0.0 %     -0.2 %
Valuation allowance     34.0 %     34.1 %
Effective income tax rate     %     %

 

The Company’s tax returns for the previous three years remain open for audit by the respective tax jurisdictions.

SUBSEQUENT EVENTS
SUBSEQUENT EVENTS

NOTE 14 ‒ SUBSEQUENT EVENTS

 

In March, 2017, we sold $200,000 of the Company’s securities consisting of 200 shares of Series C 0% Convertible Preferred Stock and an aggregate of 800,019 common stock purchase warrants as described below. The Series C Preferred Stock has a stated value of $1,000 and is immediately convertible into 266,673 shares of the Company’s common stock, subject to certain beneficial ownership limitations, at a conversion price equal to $0.75, subject to adjustment. The Conversion Price is subject to certain reset adjustments as more fully described in the Certificate of Designation (as defined below), including (a) the date of any future amendment to the Company’s certificate of incorporation with respect to a reverse stock split. The Series C Preferred Stock has anti-dilution protection until such the twelve (12) month anniversary of the issuance of the Series C Preferred Stock.

 

The Investors also received an aggregate of approximately: (i) 266,673 Series M common stock purchase warrants (“Series M Warrants”), (ii) 266,673 Series N common stock purchase warrants (“Series N Warrants”) and (iii) 266,673 Series O common stock purchase warrants (“Series O Warrants”) (collectively, the “Warrants”). The Series M Warrants have an exercise price of $0.90 per share, subject to adjustment, and a term of five (5) years from the date of issuance, the Series N Warrants have an exercise price of $0.75 per share, subject to adjustment, and a term of six (6) months from the date of issuance and the Series O warrants have an exercise price of $0.75, subject to adjustment, and a term of twelve (12) months from the date of issuance. The Warrants are immediately exercisable and separately transferable from the Series C Preferred Stock. In the event that the shares underlying the Warrants are not subject to a registration statement at the time of exercise, the Warrants may be exercised on a cashless basis after 6 months from the issuance date. The Warrants also contain provisions providing for an adjustment in the underlying number of shares and exercise price in the event of stock splits or dividends and fundamental transactions. Additionally, the Warrants contain anti-dilution protection until the twelve (12) month anniversary of the issuance date.

 

On February 28, 2017, Russell Richerson, PhD, resigned as chief operating officer of the Company, effective immediately. In connection with his resignation and in consideration of his years of service, the Company and Dr. Richerson entered into a separation release of claims agreement (“Separation Agreement”) pursuant to which the Company: (i) issued Dr. Richerson a warrant to purchase 76,726 shares of Common Stock with an exercise price of $0.75 per share and a term of three and a half (3.5) years, (ii) agreed to make the vested portion of any options held by Dr. Richerson, exercisable at any time during their remaining term regardless of any termination provisions contained in the applicable equity compensation plans pursuant to which such awards were made (collectively, the “Awards”) and (iii) agreed to reduce the exercise prices of such Awards to $0.75 per share for the duration of their respective terms. In consideration of the foregoing, Dr. Richerson agreed to release the Company from any and all claims, including any rights or obligations as contained in his prior employment agreement, as amended. 

 

Between January 1 and April 5, 2017, we issued a total of 133,585 shares of common stock upon the conversion of 31.8 shares of Series A Preferred Stock and 39 shares of Series B Preferred Stock.

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. Significant estimates include the fair value of derivative instruments, stock-based compensation, recognition of clinical trial costs and other accrued liabilities. 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 toxicology and other studies, manufacturing, clinical trials, compensation and consulting costs.  

 

We incurred research and development expenses of $1.1 and $2.3 million for the years ended December 31, 2016 and 2015, respectively.

Cash Equivalents

 

For purposes of the statements of cash flows, we consider all highly liquid debt instruments purchased with a maturity date of three months or less to be cash equivalents. We maintain our cash in bank deposit accounts which, at times, may exceed applicable government mandate insurance limits. We have not experienced any losses in our accounts.

Concentrations of Credit Risk

 

Financial instruments and related items, which potentially subject the Company to concentrations of credit risk, consist primarily of cash and cash equivalents. The Company places its cash and temporary cash investments with credit quality institutions. At times, such investments may exceed applicable government mandated insurance limits. Cash and cash equivalents were $0.5 million and $2.5 million at December 31, 2016 and 2015, respectively. As of December 31, 2016 and 2015, there was approximately $0.3 million and $2.1 million in cash over the federally insured limit, respectively.

 

We currently outsource all manufacturing of our clinical supplies to single source manufactures. We also have a single source supplier for the active ingredient in our prodrug compounds, including mipsagargin. A change in these suppliers could cause a delay in manufacturing and/or clinical trials, which would adversely affect our Company.

Intangible Assets

  

Intangible assets consist of licensed technology, patents, and patent applications (see Note 5). The assets associated with licensed technology are recorded at cost and are being amortized on the straight line basis over their estimated useful lives of twelve to seventeen years.

Office Equipment

 

Office equipment is stated at cost less accumulated depreciation.  Depreciation is calculated on the straight line basis over the estimated useful lives of the assets of three to five years. Expenditures for repair and maintenance which do not materially extend the useful lives of property and equipment are charged to expense. When property or equipment is sold or otherwise disposed of, the cost and related accumulated depreciation are removed from the respective accounts with the resulting gain or loss reflected in operations. Management periodically reviews the carrying value of its office equipment for impairment.

 

Depreciation expense was approximately $4,000 for each of the years ended December 31, 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 December 31, 2016 and 2015, as they would be anti-dilutive:

 

    Year Ended December 31,  
    2016     2015  
Shares underlying options outstanding     268,876       292,172  
Shares underlying warrants outstanding     5,203,436       1,409,248  
Shares underlying convertible preferred stock outstanding     3,770,833       411,806  
      9,243,145       2,113,226  

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 derivative liabilities. The Company values these derivative liabilities using the Black-Scholes option valuation 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

  

The U.S. GAAP Valuation Hierarchy 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 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are 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 inputs are 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 December 31, 2016 and 2015. The tables below summarize the fair values of our financial liabilities as of December 31, 2016 and 2015 (in thousands):

 

    Fair Value at
December 31,
    Fair Value Measurement Using  
    2016     Level 1     Level 2     Level 3  
                         
Derivative liability   $ 2,541     $     $     $ 2,541  

 

    Fair Value at
December 31,
    Fair Value Measurement Using  
    2015     Level 1     Level 2     Level 3  
                         
Derivative liability   $ 1,177     $     $     $ 1,177  

 

The reconciliation of the derivative liability measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows (in thousands):

 

Balance, January 1, 2015   $  
Additions to derivative instruments     1,358  
Loss (gain) on change in fair value of derivative liability     (181 )
Balance, December 31, 2015     1,177  
Additions to derivative instruments     3,890  
Reclassification on conversion     (3 )
Loss (gain) on change in fair value of derivative liability     (2,523 )
Balance, December 31, 2016   $ 2,541  

Income Taxes

 

Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income and the reversal of deferred tax liabilities during the period in which the related temporary difference becomes deductible.

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 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.

 

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 December 31, 2016 and 2015, as they would be anti-dilutive:

 

    Year Ended December 31,  
    2016     2015  
Shares underlying options outstanding     267,209       292,140  
Shares underlying warrants outstanding     5,203,436       1,409,248  
Shares underlying convertible preferred stock outstanding     3,770,833       411,806  
      9,241,478       961,779  

The tables below summarize the fair values of our financial liabilities as of December 31, 2016 and 2015 (in thousands):

 

    Fair Value at
December 31,
    Fair Value Measurement Using  
    2016     Level 1     Level 2     Level 3  
                         
Derivative liability   $ 2,541     $     $     $ 2,541  

 

    Fair Value at
December 31,
    Fair Value Measurement Using  
    2015     Level 1     Level 2     Level 3  
                         
Derivative liability   $ 1,177     $     $     $ 1,177  

The reconciliation of the derivative liability measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows (in thousands):

 

Balance, January 1, 2015   $  
Additions to derivative instruments     1,358  
Loss (gain) on change in fair value of derivative liability     (181 )
Balance, December 31, 2015     1,177  
Additions to derivative instruments     3,890  
Reclassification on conversion     (3 )
Loss (gain) on change in fair value of derivative liability     (2,523 )
Balance, December 31, 2016   $ 2,541  
SUPPLEMENTAL CASH FLOW INFORMATION (Tables)
Schedule of additional information of cash flow

The following table contains additional information for the periods reported (in thousands).

  

    Year Ended December 31,  
    2016     2015  
Non-cash financial activities:                
Reversal of accrued prior year compensation credited to paid-in capital   $ 2,053     $  
Derivative liability issued     2,845        
Common/Preferred stock and warrants issued for fees     50       175  
Common stock issued on conversion of notes payable           139  
ACCRUED EXPENSES (Tables)
Schedule of accrued expenses

Accrued expenses consist of the following (in thousands):

 

    December 31,  
    2016     2015  
             
Accrued compensation and benefits   $ 62     $ 2,134  
Accrued research and development     126       152  
Accrued other     196       146  
Total accrued expenses   $ 384     $ 2,432  
DERIVATIVE LIABILITY (Tables)
Schedule of black scholes valuations of derivatives

The significant assumptions used in the Black Scholes valuations of the derivatives at December 31, 2016 are as follows:

 

    2016
Volatility   97%-215%
Expected term (years)   2 - 60 months
Risk-free interest rate   0.62% -1.93%
Dividend yield   None

  

The significant assumptions used in the Black Scholes valuations of the derivatives at December 31, 2015 are as follows:

 

    2015
Volatility   84%-85%
Expected term   18 months
Risk-free interest rate   0.75%
Dividend yield   None
STOCK OPTIONS (Tables)

The Company has recorded aggregate stock-based compensation expense related to the issuance of stock option awards in the following line items in the accompanying consolidated statement of losses (in thousands):

 

    Year Ended December 31,  
    2016     2015  
Research and development   $ 41     $ 45  
General and administrative     72       93  
Total stock-based compensation expense   $ 113     $ 138  

The following table summarizes stock option activity under the Plans:

 

    Number of
shares
    Weighted-
average
exercise
price
    Weighted-
average
remaining
contractual term
(in years)
    Aggregate
intrinsic
value (in
thousands)
 
                         
Outstanding at December 31, 2014     289,535     $ 48.60                  
Granted     12,553     $ 23.70                  
Exercised                            
Forfeited     (9,916 )   $ 62.40                  
Outstanding at December 31, 2015     292,172     $ 48.00       3.2     $  
Granted     139,253     $ 4.37                  
Forfeited     (162,549 )   $ 49.92                  
Outstanding at December 31, 2016     268,876     $ 24.15       4.6     $  
                                 
Exercisable at December 31, 2016     151,313     $ 39.54       3.1     $  

The following table summarizes weighted-average assumptions using the Black-Scholes option-pricing model used on the date of the grants issued for the years ended December 31, 2016 and 2015:

 

    Year Ended December 31,  
    2016     2015  
Volatility     90.6 %     58.4 %
Expected term (years)     1.9       3.4  
Risk-free interest rate     0.77 %     1.0 %
Dividend yield     None       None  
WARRANTS (Tables)

Transactions involving our 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, 2014     663,383     $ 48.30                  
Granted     941,841     $ 8.10                  
Exercised     (153,322 )     5.70                  
Forfeited     (42,535 )   $ 93.60                  
Outstanding at December 31, 2015     1,409,367     $ 23.70       2.8     $ 8.4  
Granted     4,140,557     $ 0.81                  
Exercised     -     $ -                  
Forfeited     (346,488 )   $ 37.89                  
Outstanding at December 31, 2016     5,203,436     $ 4.56       2.25     $ -  
                                 
Exercisable at December 31, 2016     5,196,822     $ 4.56       2.25     $ -

The following table summarizes outstanding warrants to purchase common stock as of December 31, 2016:

 

    Number of
shares
    Weighted
Average
Exercise
price
    Expiration
Issued to consultants     28,087     $ 26.45     June 2017 through August 2023
Issued pursuant to 2013 financings     155,819     $ 61.11     December 2017 through August 2018
Issued pursuant to 2014 financings     96,412     $ 34.50     June 2019
Issued pursuant to 2015 financings     789,776     $ 8.63     January 2017 through January 2021
Issued pursuant to 2016 financings     4,133,342     $ 0.80     June 2017 through December 2021
      5,203,436              

    Year Ended December 31,  
    2016     2015  
Volatility     77 %     72.6 %
Expected term (years)     6.7       1.8  
Risk-free interest rate     1.87 %     0.6 %
Dividend yield     None       None  
INCOME TAXES (Tables)

Significant components of deferred tax assets and liabilities are as follows (in thousands):

  

    2016     2015  
Deferred tax assets:                
Net operating loss carryover   $ 12,798     $ 11,066  
Stock-based compensation     3,109       3,768  
Other     75       (60 )
Tax credits     458       456  
Total deferred tax assets     16,440       15,230  
Less: valuation allowance     (16,440 )     (15,230 )
Net deferred tax assets   $     $  

The actual tax benefit differs from the expected tax benefit for the years ended December 31, 2016 and 2015 (computed by applying the U.S. Federal Corporate tax rate of 34% to income before taxes) are as follows:

  

    2016     2015  
Statutory federal income tax rate     -34.0 %     -34.0 %
Non-deductible items     0.0 %     0.1 %
Adjustment for R&D Credit     -0.0 %     -0.2 %
Valuation allowance     34.0 %     34.1 %
Effective income tax rate     %     %
BACKGROUND (Details Narrative)
0 Months Ended 12 Months Ended
Nov. 4, 2016
Dec. 31, 2016
Description of reverse stock split

We effected a one (1) for thirty (30) reverse stock split of our common stock.

Description of reverse stock split

1:30

MANAGEMENT'S PLANS TO CONTINUE AS A GOING CONCERN (Details Narrative) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2016
Dec. 31, 2015
Dec. 31, 2014
Management Plans to Continue as Going Concern [Abstract]
 
 
 
Accumulated deficit
$ (48,820)
$ (45,265)
 
Cash and cash equivalents
$ 547 
$ 2,465 
$ 2,316 
SUMMARY OF CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES (Details)
12 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Shares underlying, outstanding
9,243,145 
2,113,226 
Series A 0% Convertible Preferred Stock [Member]
 
 
Shares underlying, outstanding
3,770,833 
411,806 
Warrant [Member]
 
 
Shares underlying, outstanding
5,203,436 
1,409,248 
Employee Stock Option [Member]
 
 
Shares underlying, outstanding
268,876 
292,172 
SUMMARY OF CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES (Details 1) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2016
Dec. 31, 2015
Derivative liability
$ 2,541 
$ 1,177 
Fair Value, Inputs, Level 1 [Member]
 
 
Derivative liability
   
   
Fair Value, Inputs, Level 2 [Member]
 
 
Derivative liability
   
   
Fair Value, Inputs, Level 3 [Member]
 
 
Derivative liability
$ 2,541 
$ 1,177 
SUMMARY OF CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES (Details 2) (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Accounting Policies [Abstract]
 
 
Balance at beginning of year
$ 1,177 
    
Additions to derivative instruments
3,890 
1,358 
Reclassification on conversion
(3)
   
Loss (gain) on change in fair value of derivative liability
(2,523)
(181)
Balance at end of year
$ 2,541 
$ 1,177 
SUMMARY OF CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES (Details Narrative) (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Dec. 31, 2014
Research and development
$ 1,101 
$ 2,303 
 
Cash and cash equivalents
547 
2,465 
2,316 
Cash, FDIC insured amount
30 
2,100 
 
Depreciation
$ 4 
$ 4 
 
Minimum [Member]
 
 
 
Useful life of intangible assets
12 years 
 
 
Useful life of office equipment
3 years 
 
 
Maximum [Member]
 
 
 
Useful life of intangible assets
17 years 
 
 
Useful life of office equipment
5 years 
 
 
SUPPLEMENTAL CASH FLOW INFORMATION (Details) (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Non-cash financial activities:
 
 
Reversal of accrued prior year compensation credited to paid-in capital
$ 2,053 
    
Derivative liability issued
2,845 
   
Common/Preferred stock and warrants issued for fees
50 
175 
Common stock issued on conversion of notes payable
    
$ 139 
INTELLECTUAL PROPERTY (Details Narrative) (USD $)
In Thousands, unless otherwise specified
12 Months Ended 48 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Dec. 31, 2011
Goodwill and Intangible Assets Disclosure [Abstract]
 
 
 
Payments to acquire intangible assets
 
 
$ 212 
Amortization of intangible assets
17 
17 
 
Finite-Lived Intangible Assets, Amortization Expense, Next Twelve Months
17 
 
 
Finite-Lived Intangible Assets, Amortization Expense, Year Two
17 
 
 
Finite-Lived Intangible Assets, Amortization Expense, Year Three
17 
 
 
Finite-Lived Intangible Assets, Amortization Expense, Year Four
$ 17 
 
 
ACCRUED EXPENSES (Details) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2016
Dec. 31, 2015
Accrued Liabilities, Current [Abstract]
 
 
Accrued compensation and benefits
$ 62 
$ 2,134 
Accrued research and development
126 
152 
Accrued other
196 
146 
Total accrued expenses
$ 384 
$ 2,432 
ACCRUED EXPENSES (Details Narrative) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2016
Accrued Expenses Details Narrative
 
Accrued bonus compensation
$ 2,000 
CONVERTIBLE NOTES PAYABLE (Details Narrative) (USD $)
In Thousands, except Share data, unless otherwise specified
1 Months Ended
Oct. 31, 2015
Dec. 31, 2016
Chief Executive Officer [Member]
 
 
Convertible notes payable
 
$ 200 
Interest rate
 
4.20% 
Conversion price (in dollars per share)
 
$ 15.00 
Accrued interest
$ 33 
 
Number of shares issued
8,750 
 
Board of Directors Chairman [Member] |
Minimum [Member]
 
 
Conversion price (in dollars per share)
$ 12.00 
 
Board of Directors Chairman [Member] |
Maximum [Member]
 
 
Conversion price (in dollars per share)
$ 15.00 
 
DERIVATIVE LIABILITY (Details)
12 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Expected term (years)
 
18 months 
Risk-free interest rate
 
0.75% 
Dividend yield
   
   
Minimum [Member]
 
 
Volatility
97.00% 
84.00% 
Expected term (years)
2 months 
 
Risk-free interest rate
0.62% 
 
Maximum [Member]
 
 
Volatility
215.00% 
85.00% 
Expected term (years)
60 months 
 
Risk-free interest rate
1.93% 
 
DERIVATIVE LIABILITY (Details Narrative) (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Derivative Instruments and Hedging Activities Disclosure [Abstract]
 
 
Gain on change in fair value of the derivative liability
$ 2,500 
$ 200 
Derivative Liability
$ 2,541 
$ 1,177 
COMMITMENTS AND CONTINGENCIES (Details Narrative) (USD $)
In Thousands, except Share data, unless otherwise specified
12 Months Ended 0 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Dec. 31, 2014
Feb. 28, 2017
Subsequent Event [Member]
Dr. Richerson [Member]
Separation Agreement [Member]
Rent expenses
$ 49 
$ 57 
 
 
Warrants issued to purchase common stock
 
 
 
76,726 
Exercise price (in dollars per share)
 
 
 
$ 0.75 
Option excersice price (in dollars per share)
$ 24.15 
$ 48.00 
$ 48.60 
$ 0.75 
Warrant expiration period
 
 
 
3 years 6 months 
Gross proceeds from capital raising transactions
$ 25,000 
 
 
 
CAPITAL STOCK AND STOCKHOLDER'S EQUITY (Details Narrative) (USD $)
In Thousands, except Share data, unless otherwise specified
0 Months Ended 1 Months Ended 12 Months Ended 1 Months Ended 1 Months Ended 0 Months Ended 1 Months Ended 12 Months Ended 1 Months Ended
Nov. 4, 2016
Dec. 31, 2015
Dec. 31, 2016
Dec. 31, 2015
Dec. 31, 2016
Equity Financings 2016 [Member]
Jul. 31, 2015
July 2015 Offering [Member]
Dec. 31, 2016
Registration Rights Agreement [Member]
Mar. 31, 2015
Consultant [Member]
Dec. 31, 2016
Placement Agent [Member]
Dec. 31, 2015
Placement Agent [Member]
Jul. 31, 2015
Private Placement [Member]
Aug. 31, 2015
Business And Advisory Services [Member]
Jul. 31, 2015
Business And Advisory Services [Member]
Consultant [Member]
Dec. 31, 2015
Series H Common Stock Purchase Warrants [Member]
Dec. 31, 2015
Series I Common Stock Purchase Warrants [Member]
Dec. 31, 2015
Series G Common Stock Purchase Warrants [Member]
Dec. 15, 2016
Series A 0% Convertible Preferred Stock [Member]
Nov. 10, 2016
Series A 0% Convertible Preferred Stock [Member]
Dec. 31, 2015
Series A 0% Convertible Preferred Stock [Member]
Dec. 31, 2016
Series A 0% Convertible Preferred Stock [Member]
Dec. 31, 2015
Series F Common Stock Purchase Warrants [Member]
Jul. 31, 2015
Series D Common Stock Purchase Warrants [Member]
Jul. 31, 2015
Series E Common Stock Purchase Warrants [Member]
Dec. 31, 2016
Series B 0% Convertible Preferred Stock [Member]
Dec. 31, 2016
Series J Common Stock Purchase Warrants [Member]
Dec. 31, 2016
Series K Common Stock Purchase Warrants [Member]
Dec. 31, 2016
Series L Common Stock Purchase Warrants [Member]
Class of Stock [Line Items]
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stock issued during period, shares
 
 
 
 
 
 
 
 
 
 
119,709 
 
 
 
 
 
 
5,556 
 
1,853 
 
 
 
1,000 
 
 
 
Value of number of shares issued
 
 
 
$ 2,514 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 1 
 
 
 
$ 1 
 
 
 
Warrants issued to purchase common stock
 
 
 
 
 
 
 
 
133,334 
 
 
 
 
 
 
 
 
 
 
 
 
9,577 
 
 
 
 
 
Stock issued during period, shares, issued for services
 
 
 
 
 
 
 
1,000 
 
 
 
 
4,167 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stock issued during period, value, issued for services
 
 
 
175 
 
 
 
27 
 
 
 
 
95 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number of warrants exercised
 
 
11,239 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Class of warrant or right, exercise price of warrants or rights
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 9.00 
$ 9.00 
$ 9.00 
 
 
 
 
$ 9.00 
$ 24.00 
$ 21.00 
 
$ 0.90 
$ 0.75 
$ 0.75 
Warrant expiration period
 
 
 
 
 
 
 
 
 
 
 
 
 
5 years 
18 months 
18 months 
 
 
 
 
5 years 
5 years 
18 months 
 
5 years 
6 months 
12 months 
Stock issued during period, value, share-based compensation, forfeited
 
 
 
 
 
 
 
 
 
 
 
25 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stock issued during period, shares, share-based compensation, forfeited
 
 
 
 
 
 
 
 
 
 
 
910 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Preferred stock conversion price per share
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 0.75 
$ 4.50 
$ 4.50 
 
 
 
 
$ 0.75 
 
 
 
Number of preferred shares converted
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
25.00005 
 
 
 
 
 
 
 
 
 
Convertible preferred stock, shares issued upon conversion
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1,000 
 
 
 
Preferred stock, par or stated value per share
 
$ 0.0001 
$ 0.0001 
$ 0.0001 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sale of stock, percentage of ownership after transaction
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9.99% 
 
 
 
 
 
 
 
 
Class of warrant or right, number of securities called by warrants or rights
 
153,322 
 
153,322 
 
 
 
 
 
32,944 
 
 
 
119,048 
119,048 
205,903 
 
 
649,901 
 
 
 
 
4,000,008 
1,333,336 
1,333,336 
1,333,336 
Proceeds from preferred stock
 
2,500 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Proceeds from issuance of warrants
 
 
287 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2,500 
 
 
 
 
Class of warrant or right, outstanding
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
205,903 
 
 
 
 
 
 
Reverse stock split
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Description of agreement
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Commission
 
 
 
 
 
 
 
 
100 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Non-accountable expense allowance
 
 
 
 
 
 
 
 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Management fee
 
 
 
 
 
 
 
 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Share based compansation
 
 
113 
313 
 
 
 
 
100 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Issuance of public offering
 
 
 
 
850 
2,500 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Obligation satisfied with stock including placement agent commission
 
 
 
 
150 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Accrued bonus compensation
 
 
$ 2,000,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

We effected a one (1) for thirty (30) reverse stock split of our common stock.

1:30

Registration Rights Agreement to register the resale of 200% of the shares of common stock underlying the Series B Preferred Stock and 100% of the shares of common stock underlying the Warrants and to maintain the effectiveness thereunder. The Company also agreed to have the registration statement declared effective within 60 days from the date of the Registration Rights Agreement and keep the registration statement continuously effective until the earlier of (i) the date after which all of the securities to be registered thereunder have been sold, or (ii) the date on which all the securities to be registered thereunder may be sold without volume or manner-of-sale restrictions and without current public information pursuant to Rule 144 under the Securities Act of 1933, as amended. We are also obligated to pay the Investors, as partial liquidated damages, a fee of 1.5% of each Investor’s subscription amount per month in cash upon the occurrence of certain events, including our failure to file and / or have the registration statement declared effective within the time provided. The registration statement was filed on January 13, 2017 and was declared effective on January 31, 2017.

STOCK OPTIONS (Details) (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Total stock-based compensation expense
$ 113 
$ 138 
Research And Development [Member]
 
 
Total stock-based compensation expense
41 
45 
General And Administrative [Member]
 
 
Total stock-based compensation expense
$ 72 
$ 93 
STOCK OPTIONS (Details 1) (USD $)
12 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward]
 
 
Outstanding at begenning
292,172 
289,535 
Granted
139,253 
12,553 
Exercised
 
   
Forfeited
(162,549)
(9,916)
Outstanding at ending
268,876 
292,172 
Exercisable at ending
151,313 
 
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Roll Forward]
 
 
Outstanding at begenning
$ 48.00 
$ 48.60 
Granted
$ 4.37 
$ 23.70 
Exercised
 
   
Forfeited
$ 49.92 
$ 62.40 
Outstanding at ending
$ 24.15 
$ 48.00 
Exercisable at ending
$ 39.54 
 
Share-based Compensation Arrangement by Share-based Payment Award, Options, Weighted Average Remaining Contractual Term [Roll Forward]
 
 
Outstanding at ending
4 years 7 months 6 days 
3 years 2 months 12 days 
Exercisable at ending
3 years 1 month 6 days 
 
STOCK OPTIONS (Details 2)
12 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
 
 
Volatility
90.60% 
58.40% 
Expected term (years)
1 year 10 months 24 days 
3 years 4 months 24 days 
Risk-free interest rate
0.77% 
1.00% 
Dividend yield
0.00% 
0.00% 
STOCK OPTIONS (Details Narrative) (USD $)
In Thousands, except Share data, unless otherwise specified
12 Months Ended 12 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Dec. 31, 2016
Employee Stock Option [Member]
Consultant [Member]
Dec. 31, 2015
Employee Stock Option [Member]
Consultant [Member]
Dec. 31, 2016
Employees, And Non-Employee Directors [Member]
Employee Stock Option [Member]
Dec. 31, 2015
Employees, And Non-Employee Directors [Member]
Employee Stock Option [Member]
Dec. 31, 2016
2007 Executive Compensation Plan [Member]
Dec. 31, 2018
2007 Executive Compensation Plan [Member]
Subsequent Event [Member]
Dec. 31, 2017
2007 Executive Compensation Plan [Member]
Subsequent Event [Member]
Dec. 31, 2016
2007 Executive Compensation Plan [Member]
Common Stock [Member]
Dec. 31, 2016
2009 Executive Compensation Plan [Member]
Dec. 31, 2016
Inducement Award Stock Option Plan [Member]
Maximum annual grants
 
 
 
 
 
 
50,000 
 
 
 
 
 
Maximum grants under plan
 
 
 
 
127,417 
5,300 
 
 
 
 
 
 
Number of award authorized