UNITED STATES SECURITIES AND

EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

[X] QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

 [  ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT 1934

 

For the quarterly period ended SeptemberJune 30, 20152016

Commission File No. 0-22179

 

 

GUIDED THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

(State or other jurisdiction of incorporation or organization)

 

58-2029543

(I.R.S. Employer Identification No.)

 

5835 Peachtree Corners East, Suite D

5835 Peachtree Corners East, Suite D

Norcross, Georgia  30092

Norcross, Georgia 3092

(Address of principal executive offices) (Zip Code)

 

(770) 242-8723

(Registrant’s telephone number, including area code)     

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days: Yes [ ] No [ X ]

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).   Yes [ X ] No [  ]

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-12 of the Exchange Act (Check one):

 

Large Accelerated filer _____ Accelerated filer ____ Non-accelerated filer_____ Smaller Reporting Company X

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act. 

Yes [   ]  No [X]

 

As of October 30, 2015,August 11, 2016, the registrant had outstanding 163,741,755153,919,886 shares of Common Stock.

 

    

 1 
 

 

 

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY

 

INDEX

 

 

Part I.  Financial Information 3
  
Item 1.     Financial Statements 3
  
                        Condensed Consolidated Balance Sheets (Unaudited) -as of 
                        SeptemberJune 30, 20152016 and December 31, 20142015 3
  
                        Condensed  Consolidated Statements of Operations (Unaudited) 
                        Three and ninesix months ended SeptemberJune 30, 20152016 and 20142015 4
  
                        Condensed Consolidated Statements of Cash Flows (Unaudited) for the 
                        NineSix months ended SeptemberJune 30, 20152016 and 20142015 5
  
                        Notes to Condensed Consolidated Financial Statements (Unaudited) 6
  
Item 2.      Management's Discussion and Analysis of Financial Condition and Results of Operations1719
  
Item 3.     Quantitative and Qualitative Disclosures About Market Risk2123
  
Item 4.     Controls and Procedures2123
  
Part II. Other Information2224
       Item 1.     Legal Proceedings22        24
  
       Item 1A.  Risk Factors2225
  
       Item 2.     Unregistered Sale of Equity Securities and Use of Proceeds.        2225
  
       Item 3.     Defaults Upon Senior Securities    2225
  
       Item 4.     Mine Safety Disclosures2225
  
       Item 5.     Other Information                                                                                                                                                                                                        information2225
  
       Item 6.    Exhibits2325
  
Signatures2426
  

 

 

 

 2 
 

 

 

PART I - FINANCIAL INFORMATION

ITEM 1.  FINANCIAL STATEMENTS

 

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited, in Thousands)
     
ASSETS  September 30, 2015   December 31, 2014 
CURRENT ASSETS:        
    Cash and cash equivalents $172  $162 
    Accounts receivable, net of allowance for doubtful accounts of $63 and $76 at
            September 30, 2015 and December 31, 2014, respectively
  219   338 
    Inventory, net of reserves of $97 and $144, at September 30, 2015 and December 31, 2014, respectively  912   1,180 
    Other current assets  979   99 
                    Total current assets  2,282   1,779 
         
    Property and equipment, net  377   587 
    Other assets  108   101 
    Debt issuance costs, net  —     564 
                    Total noncurrent assets  485   1,252 
         
                    TOTAL ASSETS $2,767  $3,031 
         
LIABILITIES AND STOCKHOLDERS’ DEFICIT        
CURRENT LIABILITIES:        
    Short-term notes payable, including related parties $784  $646 
    Note payable in default  129   —   
    Current portion of long-term debt  —     123 
    Short-term convertible note payable, net of discount  935     1,062 
    Accounts payable  1,466   1,733 
    Accrued liabilities  1,616   1,015 
    Deferred revenue  33   24 
                    Total current liabilities  4,963   4,603 
         
     Warrants, at fair value  1,287   2,070 
      Long-term debt, net  —     40 
     Convertible note, net of discount  —     783 
                    Total long-term liabilities  1,287   2,893 
         
                    TOTAL LIABILITIES  6,250   7,496 
         
STOCKHOLDERS’ DEFICIT:        
Series B convertible preferred stock, $.001 par value; 3 shares authorized, zero and
   1.2 shares issued and outstanding as of September 30, 2015 and December 31,
   2014, respectively. (Liquidation preference of zero and $1,200 at September 30,
   2015 and December 31, 2014, respectively)
  —     678 
Series C convertible preferred stock, $.001 par value; 9.0 shares authorized, 5.9 shares
   issued and outstanding as of September 30, 2015 and none authorized or issued and
   outstanding at December 31, 2014, respectively. (Liquidation preference of $5,894
   at September 30, 2015 and none at December 31, 2014)
  2,044   —   
Common stock, $.001 Par value; 500,000 shares authorized, 143,681 and 96,889
   shares issued and outstanding as of September 30, 2015 and December 31, 2014, respectively
  143   97 
Additional paid-in capital  114,537   107,952 
Treasury stock, at cost  (132)  (132)
Accumulated deficit  (120,075)  (113,060)
         
                   TOTAL STOCKHOLDERS’ DEFICIT  (3,483)  (4,465)
         
                   TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT $2,767  $3,031 
    

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS Unaudited (in Thousands)
 
ASSETS  June 30, 2016   December 31, 2015 
CURRENT ASSETS:        
Cash and cash equivalents $22  $35 
  Accounts receivable, net of allowance for doubtful accounts of $78 and $95 at June 30, 2016 and December 31, 2015, respectively  289   190 
  Inventory, net of reserves of $140 and $118, at June 30, 2016 and   December 31, 2015, respectively  1,238   1,119 
Prepaid expenses and deposits  502   780 
                    Total current assets  2,051   2,124 
         
Property and equipment, net  217   318 
Other assets  45   121 
                    Total noncurrent assets  262   439 
         
                    TOTAL ASSETS $2,313  $2,563 
         
LIABILITIES AND STOCKHOLDERS’ DEFICIT        
CURRENT LIABILITIES:        
Short-term notes payable, including related parties $532  $752 
Note payable in default, including related parties  596   133 
Convertible note – in default  1,830   —   
Short-term convertible notes payable, net  602   686 
Accounts payable  2,208   1,824 
Accrued liabilities  2,149   1,907 
Deferred revenue  41   217 
                    Total current liabilities  7,958   5,519 
         
Warrants, at fair value  1,491   2,606 
         
                    TOTAL LIABILITIES  9,449   8,125 
         
STOCKHOLDERS’ DEFICIT:        
  Series C convertible preferred stock, $.001 par value; 9.0 shares authorized, 2.1 and 5.6 shares issued and outstanding as of June 30, 2016 and December 31, 2015,   (Liquidation preference of $2,139 and $5,555 at June 30, 2016 and December 31, 2015)  801   2,052 
  Series C1 convertible preferred stock, $.001 par value; 20.3 shares authorized, 4.3 shares issued and outstanding as of June 30, 2016   (Liquidation preference of   $4,312 at June 30, 2016)  701   —   
  Common stock, $.001 Par value; 1,000,000 shares authorized, 84,952   and 2,371 shares issued and outstanding as of June 30, 2016 and December 31, 2015  376   236 
Additional paid-in capital  116,192   114,845 
Treasury stock, at cost  (132)  (132)
Accumulated deficit  (125,074)  (122,563)
         
                   TOTAL STOCKHOLDERS’ DEFICIT  (7,136)  (5,562)
         
                   TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT $2,313  $2,563 
  
 The accompanying notes are an integral part of these condensed consolidated financial statements. 
         

 

 3 
 

GUIDED THERAPEUTICS INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, inIn Thousands)

  

   

FOR THE THREE MONTHS

ENDED SEPTEMBER 30,

   

FOR THE NINE MONTHS

ENDED SEPTEMBER 30,

 
   2015   2014   2015   2014 
REVENUE:                
          Sales – devices and disposables $94  $262  $323  $586 
          Cost of goods sold  230   260   544   723 
                                       Gross profit (loss)  (136)  2   (221)  (137)
                 
       Contract and grant revenue  8   22   33   52 
                 
COSTS AND EXPENSES:                
         Research and development  413   892   1,090   2,122 
         Sales and marketing  187   135   542   762 
         General and administrative  1,110   1,412   2,863   3,551 
                                       Total  1,710   2,439   4,495   6,435 
                 
                                       Operating loss  (1,838)  (2,415)  (4,683)  (6,520)
                 
OTHER INCOME AND (EXPENSES)                
                 
        Other income  10   9   69   14 
        Changes in fair value of warrants  41   (195)  710   266 
        Interest expense  (404)  (371)  (1,240)  (445)
                 
                                  Other income and (expenses)  (353)  (557)  (461)  (165)
                 
LOSS  BEFORE INCOME TAXES  (2,191)  (2,972)  (5,144)  (6,685)
                 
PROVISION FOR INCOME TAXES  —     —     —     —   
                 
NET LOSS  (2,191)  (2,972)  (5,144)  (6,685)
                 

PREFERRED STOCK DIVIDENDS AND

DEEMED DIVIDENDS

  (545)  (39)  (1,871)  (128)
                 

NET LOSS ATTRIBUTABLE TO COMMON

STOCKHOLERS

  (2,736) $(3,011) $(7,015) $(6,813)
                 

BASIC AND DILUTED NET LOSS PER SHARE

ATTRIBUTABLE TO COMMON

STOCKHOLDERS

                

 

 $(0.02) $(0.04) $(0.06) $(0.09)
                 

WEIGHTED AVERAGE SHARES

OUTSTANDING

  124,809   77,651   109,902   74,052 

   

FOR THE THREE 

MONTHS

ENDED JUNE 30,

   

FOR THE SIX

MONTHS

ENDED JUNE 30,

 
                 
   2016   2015  2016   2015 
REVENUE:                
          Sales – devices and disposables $129  $103  $391  $229 
          Cost of goods sold  33   207   101   314 
                                Gross profit (loss)  96   (104)  290   (85)
                 
OPERATING EXPENSES:                
         Research and development  148   305   438   677 
         Sales and marketing  86   183   203   355 
         General and administrative  760   1,019   1,677   1,982 
                                 Total operating expenses  994   1,507   2,318   3,014 
                 
                                 Operating loss  (898)  (1,601)  (2,028)  (3,074)
                 
OTHER INCOME (EXPENSES):                
         Other income  21   284   44   290 
         Interest expense  (1,213)  (323)  (1,371)  (815)
         Change in fair value of warrants  211   (66)  1,606   648 
                                 Total other income (expenses)  (981)  (105)  279   123 
                 
LOSS FROM OPERATIONS  (1,879)  (1,706)  (1,749)  (2,951)
                 
PROVISION FOR INCOME TAXES  —     —     —     —   
                 
NET LOSS $(1,879) $(1,706) $(1,749) $(2,951)

 

PREFERRED STOCK DIVIDENDS

  (292)  (1,295)  (762)  (1,326)

 

NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS

 $(2,171) $(3,001) $(2,511) $(4,277)
                 
NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS                
      BASIC $(0.07) $(0.03) $(0.14) $(0.04)
      DILUTED $(0.07) $(0.03) $(0.14) $(0.04)
                 
WEIGHTED AVERAGE SHARES OUTSTANDING                
      BASIC  32,666   107,256   17,875   102,326 
      DILUTED  32,666   107,256   17,875   102,326 

  

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

  

 4 
 

  

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, in Thousands)
  FOR THE NINE MONTHS ENDED SEPTEMBER 30,
  2015 2014
CASH FLOWS FROM OPERATING ACTIVITIES:        
     Net loss $(5,144) $(6,685)
     Adjustments to reconcile net loss to net cash used in operating activities:        
           Bad debt expense  —     32 
           Depreciation and amortization  990   359 
           Stock based compensation  802   852 
           Non- employee stock based compensation  400   —  
           Change in fair value of warrants  (710)  (301)
 Changes in operating assets and liabilities:        
           Accounts receivable  119   (316)
           Inventory  268   (11)
           Other current assets  (497)  (330)
           Other assets  (390)  184 
           Accounts payable  (267)  774 
           Deferred revenue  9   (4)
           Accrued liabilities  830   639 
                         Total adjustments  1,554   1,877 
                         Net cash used in operating activities  (3,590)  (4,807)
         
CASH FLOWS FROM INVESTING ACTIVITIES:        
       Additions to fixed assets  (2)  (144)
                         Net cash used in investing activities  (2)  (144)
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
      Net proceeds from issuance of preferred stock and warrants  3,115   —   
      Net proceeds from issuance of common stock and warrants  720   201 
      Proceeds from debt financing, net of issuance costs  415   4,571 
      Payments made on notes payable  (789)  (459)
      Proceeds from options and warrants exercised  141   67 
                        Net cash provided by financing activities  3,602   4,380 
         
NET CHANGE IN CASH AND CASH EQUIVALENTS  10   (571)
CASH AND CASH EQUIVALENTS, beginning of year  162   613 
CASH AND CASH EQUIVALENTS, end of period $172  $42 
SUPPLEMENTAL SCHEDULE OF:        
Cash paid for:        
     Interest $76  $33 
         
NONCASH INVESTING AND FINANCING ACTIVITIES:        
  Deemed dividend on beneficial conversion feature of Series C preferred stock $148  $—   
  Deemed dividend on price changes for Series B preferred stock warrants $64  $—   
  Deemed dividend on December 2014 public offering warrants $1,049  $—   
      Term changes on Series B preferred stock and December 2014 public offering
          warrants resulting in transfer to equity
 $1,412  $—   
       Debt issuance cost paid via warrants $—   $522 
  Issuance of common stock as debt repayment $902  $ 
  Issuance of common stock as board compensation $—  $355 
  Conversion of convertible debt into common stock $—   $800 
  Conversion of accrued expenses into common stock $—   $178 
  Repayment of deferred compensation via issuance of preferred stock  $100  $—  
  Dividends on preferred stock $610  $—  

GUIDED THERAPEUTICS INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, in Thousands)
 
  

FOR THE SIX MONTHS

ENDED JUNE 30,

  2016 2015
CASH FLOWS FROM OPERATING ACTIVITIES:        
     Net loss $(1,749) $(2,951)
     Adjustments to reconcile net loss to net cash used in operating activities:        
           Bad debt expense  20   —   
           Depreciation  102   144 
           Amortization  816   543 
           Stock based compensation  53   529 
           Change in fair value of warrants  (1,606)  (648)
     Changes in operating assets and liabilities:        
           Inventory  (120)  194 
           Accounts receivable  (119)  56 
           Other current assets  280   73 
           Other assets  27   10 
           Accounts payable  384   231 
           Deferred revenue  (176)  12 
           Accrued liabilities  549   613 
                         Total adjustments  210   1,757 
         
                         Net cash used in operating activities  (1,539)  (1,194)
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
      Net proceeds from issuance of preferred stock and warrants, net  —     2,033 
      Net proceeds from issuance of common stock and warrants, net  —     720 
      Proceeds from debt financing, net of discounts and debt issuance costs  1,618   203 
      Proceeds from options and warrants exercised  —     141 
      Payments made on notes payable  (92)  (91)
         
                        Net cash provided by financing activities  1,526   3,006 
         
NET CHANGE IN CASH AND CASH EQUIVALENTS  (13)  1,812 
CASH AND CASH EQUIVALENTS, beginning of year  35   162 
CASH AND CASH EQUIVALENTS, end of period $22  $1,974 
SUPPLEMENTAL SCHEDULE OF:        
Cash paid for:        
      Interest $1  $56 
NONCASH INVESTING AND FINANCING ACTIVITIES:        
  Deemed dividend on beneficial conversion feature of Series C preferred stock $—    $148 
  Deemed dividend on price changes for Series B preferred stock warrants $—    $72 
  Deemed dividend on December 2014 public offering warrants $—    $1,042 
    Term changes on Series B preferred stock and December 2014 public offering warrants resulting in transfer to equity $—    $1,412 
  Issuance of common stock as debt repayment $225  $833 
  Dividends on preferred stock $762  $64 
         

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 5 
 

 

 

GUIDED THERAPEUTICS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

  

1.   BASIS OF PRESENTATION

  

The accompanying unaudited condensed consolidated financial statements included herein have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”) for interim financial reporting and with the instructions to Form 10-Q and Article 10 of Regulation S-X by Guided Therapeutics, Inc. (formerly SpectRx, Inc.), together with its wholly owned subsidiary InterScan, Inc., (“Interscan”) (formerly Guided Therapeutics, Inc.), collectively referred to herein as the “Company”. Accordingly, they do not include all information and footnotes required by GAAP for complete financial statements. These statements reflect adjustments, all of which are of a normal, recurring nature, and which are, in the opinion of management, necessary to present fairly the Company’s financial position as of SeptemberJune 30, 2015,2016, results of operations for the three and ninesix months ended SeptemberJune 30, 20152016 and 2014,2015, and cash flows for the ninesix months ended SeptemberJune 30, 20152016 and 2014.2015. The results of operations for the three and ninesix months ended SeptemberJune 30, 20152016 are not necessarily indicative of the results for a full fiscal year. Preparing financial statements requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and disclosure of contingent assets and liabilities. Actual results could differ from those estimates. These financial statements should be read in conjunction with the financial statements and notes thereto included in the Company’s annual report on Form 10-K for the year ended December 31, 2014.2015.

On February 24, 2016, the Company implemented a 1:100 reverse stock split of its issued and outstanding common stock. The reverse stock split decreased the Company’s issued and outstanding shares of common stock from 237,101,702 shares of Common Stock to 2,371,007 shares as of that date. See Note 4, Stockholders’ Deficit. Unless otherwise specified, all per share amounts are reported on a post-stock split basis, as of June 30, 2016.

 

The Company's prospects must be considered in light of the substantial risks, expenses and difficulties encountered by entrants into the medical device industry. This industry is characterized by an increasing number of participants, intense competition and a high failure rate. The Company has experienced net losses since its inception and, as of SeptemberJune 30, 2015,2016, it had an accumulated deficit of approximately $120.0$125.1 million. Through SeptemberJune 30, 2015,2016, the Company has engaged primarily indevoted substantial resources to research and development efforts and the early stages of marketing its products.efforts. The Company does not have significant experience in manufacturing, marketing or selling its products. The CompanyCompany's development efforts may not result in commercially viable products and it may not be successful in growing sales forintroducing its products. Moreover, the Company may not obtain required regulatory clearances or approvals.approvals may not be obtained. The Company's products may not ever gain market acceptance and the Company may not ever generate significant revenuesachieve levels of revenue to sustain further development costs and support ongoing operations or achieve profitability. The development and commercialization of the Company's products requireswill require substantial development, regulatory, sales and marketing, manufacturing and other expenditures. The Company expects operating losses to continue through at least the end of 2015foreseeable future as it continues to expend substantial resources to introducecomplete development of its products, obtain regulatory clearances or approvals build its marketing, sales, manufacturing and finance capabilities, and conduct further research and development.

 

Going Concern

 

The Company’s consolidated financial statements have been prepared and presented on a basis assuming it will continue as a going concern. The factors below raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty. If the Company is unable to continue operations, it may have to the extent practicable, liquidate and/or file for bankruptcy protection.

Liquidity

 

At SeptemberJune 30, 2015,2016, the Company had negativea working capital deficit of approximately $2.7$5.9 million and the stockholders’ deficit was approximately $3.5$7.1 million, primarily due to recurring net losses from operations and deemed dividends on warrants and preferred stock, offset by proceeds from the exercise of options and warrants and proceeds from the sales of stock.

 

6

The Company’s capital-raising efforts are ongoing. If sufficient capital cannot be raised byplans with respect to its liquidity management include the end of fourth quarter of 2015, thefollowing:

The Company has plans to curtailcurtailed operations by reducingand reduced discretionary spending and staffing levels, and attempting to operate bylevels.
The Company is only pursuing activities for whichwhere it has external financial support. However, there can be no assurance that such external financial support will be sufficient to maintain even limited operations operations.
The Company is seeking additional capital in the private and/or that the Company will be able to raise additional funds on acceptable terms, or at all. In such a case, the Company might be required to enter into unfavorable agreements or, if that is not possible, be unablepublic equity markets to continue operations and tobuild sales, marketing, and distribution. The Company is currently evaluating additional equity and debt financing opportunities and may execute them when appropriate. However, there can be no assurances that the extent practicable, liquidate and/Company can consummate such a transaction, or file for bankruptcy protection.

consummate a transaction at favorable pricing.

The Company is seeking additional sources of cash flow with strategic businesses.
The Company had warrants exercisable for approximately 152.3369 million shares of its common stock outstanding at SeptemberJune 30, 2015,2016, with exercise prices of $0.0900$0.0042 to $1.05$105.00 per share. Exercises of these warrants would generate a total of approximately $16.0$6.3 million in cash, assuming full exercise, although the Company cannot be assured that holders will exercise any warrants. Management may obtain additional funds through the private sale of preferred stock or debt securities, public and private sales of common stock, and grants, if available.

warrants
 6

The Company is following up with the FDA regarding the Non Approvable letter that the Company received in May 2015. The FDA has requested that the Company provide additional clinical data and the Company is in discussions with the FDA to agree on the protocol and amount of clinical data required. FDA approval is not expected in the next 12 months.

2.   SIGNIFICANT ACCOUNTING POLICIES

 

The Company’s significant accounting policies were set forth in the audited financial statements and notes thereto for the year ended December 31, 20142015 included in its annual report on Form 10-K, filed with the Securities and Exchange Commission (“SEC”).

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant areas where estimates are used include the allowance for doubtful accounts, inventory valuation and input variables for Black-Scholes, Monte Carlo simulations and Lattice Modelbinomial calculations.

 

Principles of Consolidation

 

The accompanying consolidated financial statements include the accounts of Guided Therapeutics, Inc. and its wholly owned subsidiary.

 

Cash EquivalentsAccounting Standard Updates

 

The Company considers all highly liquid investmentsIn April 2015, the FASB issued Accounting Standards Update No. 2015-03, Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs, or ASU 2015-03. ASU 2015-03 amends current presentation guidance by requiring that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with an original maturitydebt discounts. Prior to the issuance of three months or less when purchasedASU 2015-03 debt issuance costs were required to be a cash equivalent.presented as an asset in the balance sheet. On January 1, 2016, the Company adopted the provisions of ASU 2015-03 and prior period amounts have been reclassified to conform to the current period presentation

 

Accounts Receivable

 

The Company performs periodic credit evaluations of its customers’ financial conditions and generally does not require collateral. The Company reviews all outstanding accounts receivable for collectability on a quarterly basis. An allowance for doubtful accounts is recorded for any amounts deemed uncollectable. The Company does not accrue interest receivable on past due accounts receivable.

 

Revenue Recognition

 

Revenue from the sale of the Company’s products is recognized upon shipment of such products to its customers. The Company recognizes revenue from contracts on a straight line basis, over the terms of the contract. The Company recognizes revenue from grants based on the grant agreement, at the time the expenses are incurred.  

 

During the three and six months ended June 30, 2016, the majority of the Company’s revenues were from two customers. Revenue from these customers totaled approximately $283,000 or 72% for the period ended June 30, 2016. Accounts receivable due from those customers represents 79% of total receivables at June 30, 2016.

7

Deferred Revenue

The Company defers payments received as revenue until earned based on the related contracts on a straight line basis, over the terms of the contract.

Income Taxes

The Company accounts for income taxes in accordance with the liability method. Under the liability method, the Company recognizes deferred assets and liabilities based upon anticipated future tax consequences attributable to differences between financial statement carrying amounts of assets and liabilities and their respective tax bases. The Company establishes a valuation allowance to the extent that it is more likely than not that deferred tax assets will not be utilized against future taxable income. As of December 31, 2014, the Company had approximately $68.4 million of net operating loss (“NOL”) carry forward. There was no provision for income taxes at September 30, 2015. A full valuation allowance has been recorded related to any deferred tax assets created from the NOL.

7

Stock Option Plan

The Company measures the cost of employees services received in exchange for equity awards, including stock options, based on the grant date fair value of the awards. The cost will be recognized as compensation expense over the vesting period of the awards.

Concentrations of Credit Risk

The Company, from time to time during the years covered by these consolidated financial statements, may have bank balances in excess of its insured limits. Management has deemed this a normal business risk.

 

Inventory Valuation

 

All inventories are stated at lower of cost or market, with cost determined substantially on a “first-in, first-out” basis.  Selling, general, and administrative expenses are not inventoried, but are charged to expense when purchased. At SeptemberJune 30, 20152016 and December 31, 2014,2015, our inventories were as follows (in thousands):

 

  September 30, December 31,
  2015 2014
Raw materials $739  $884 
Work in process  168   304 
Finished goods  122   136 
Inventory reserve  (117)  (144)
       Total $912  $1,180 

Other Current Assets

As of September 30, 2015, other current assets of $979 primarily consists of deposits on future inventory receipts of $382 and prepaid investor relations contract of $412, which is being amortized over one year. The remaining balance of $185 consists of various ordinary course business activities. As of December 31, 2014, other current assets consisted of various ordinary course business activities of $99.

  June 30, December 31,
  2016 2015
Raw materials $861  $686 
Work in process  285   186 
Finished goods  232   365 
Inventory reserve  (140)  (118)
       Total $1,238  $1,119 
         

Property and Equipment

 

Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over estimated useful lives of three to seven years. Leasehold improvements are depreciated at the shorter of the useful life of the asset or the remaining lease term. Depreciation expense is included in general and administrative expense on the statement of operations. Expenditures for repairs and maintenance are expensed as incurred. Property and equipment are summarized as follows at SeptemberJune 30, 20152016 and December 31, 20142015 (in thousands):

 

 September 30, December 31, June 30, December 31,
 2015 2014 2016 2015
Equipment $1,391  $1,391  $1,378  $1,377 
Software  740   737   740   740 
Furniture and fixtures  124   124   124   124 
Leasehold Improvement  180   180 
Leasehold improvement  199   199 
  2,435   2,432   2,441   2,440 
Less accumulated depreciation  (2,058)  (1,845)
Less: accumulated depreciation  (2,224)  (2,122)
Total $377  $587  $217  $318 
        

 

Other AssetsPrepaid Expenses and Deposits

 

Other assets primarily consist of long-termPrepaid expenses and deposits for various tooling projects that are being constructed for the Company. At September 30, 2015 and December 31, 2014, such balances were approximately $108,000 and $101,000, respectively.summarized as follows (in thousands):

  

June 30,

2016

 December 31,
2015
Prepaid expenses $22  $26 
Prepaid insurance  181   108 
  Prepaid investor relations  —     275 
Deposits - equipment  297   368 
Deposits - other  2   3 
            Total $502  $780 

 

 8 
 

 

Debt Issuance Costs

Accrued Liabilities

 

Debt issuanceAccrued liabilities are summarized as follows (in thousands):

  

June 30,

2016

 December 31,
2015
Accrued compensation $1,245  $1,235 
Accrued professional fees  73   154 
   Deferred rent  26   36 
Accrued warranty  65   82 
Accrued vacation  193   177 
Accrued interest  68   —   
Accrued dividends  263   167 
Other accrued expenses  216   56 
            Total $2,149  $1,907 

Research and Development

Research and development expenses consist of expenditures for research conducted by the Company and payments made under contracts with consultants or other outside parties and costs incurredassociated with internal and contracted clinical trials. All research and development costs are expensed as incurred.

Income Taxes

The Company uses the liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in securingeffect when the differences are expected to reverse. Management provides valuation allowances against the deferred tax assets for amounts that are not considered more likely than not to be realized.

The Company is current with its federal and applicable state tax returns filings. Although we have been experiencing recurring losses, we are obligated to file tax returns for compliance with Internal Revenue Service (“IRS”) regulations and that of applicable state jurisdictions. At December 31, 2015, the Company has approximately $28.0 million of net operating loss eligible to be carried forward for tax purposes at federal and applicable states level. A full valuation allowance has been recorded related the deferred tax assets generated from the net operating losses.

None of the Company’s financing arrangementsfederal or state income tax returns are capitalizedcurrently under examination by the IRS or state authorities.

Uncertain Tax Positions

Effective January 1, 2007 the Company adopted ASC guidance regarding accounting for uncertainty in income taxes. This guidance clarifies the accounting for income taxes by prescribing the minimum recognition threshold an income tax position is required to meet before being recognized in the financial statements and amortized overapplies to all income tax positions. Each income tax position is assessed using a two-step process. A determination is first made as to whether it is more likely than not that the term ofincome tax position will be sustained, based upon technical merits, upon examination by the debt. Deferred financing costs are includedtaxing authorities. If the income tax position is expected to meet the more likely than not criteria, the benefit recorded in other long term assets.the financial statements equals the largest amount that is greater than 50% likely to be realized upon its ultimate settlement. At June 30, 2016 and December 31, 2015 there were no uncertain tax positions.

 

Warrants

The Company has issued warrants, which allow the warrant holder to purchase one share of stock at a specified price for a specified period of time. The Company records equity instruments including warrants issued to non-employees based on the fair value at the date of issue. The fair value of warrants classified as equity instruments at the date of issuance is estimated using the Black-Scholes Model. The fair value of warrants classified as liabilities at the date of issuance is estimated using either the Monte Carlo Simulation model or a Binomial model.

New Accounting Pronouncements

Recently Adopted Accounting Guidance

In May 2014, the FASB issued ASU 2014-09, “Revenue from Contracts with Customers,” (“ASU 2014-09”). ASU 2014-09 outlines a new, single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry-specific guidance. This new revenue recognition model provides a five-step analysis in determining when and how revenue is recognized. The new model will require revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration a company expects to receive in exchange for those goods or services. ASU 2014-09 is effective for reporting periods beginning after December 15, 2017. Early adoption is permitted for periods beginning after December 15, 2016. The Company is evaluating the impact that adoption of this guidance will have on the determination or reporting of its financial results.

In June 2014, the FASB issued ASU 2014-12, “Accounting for Share-Based Payments When the Terms of an Award Provide that a Performance Target Could be Achieved after the Requisite Service Period,” (“ASU 2014-12”). ASU 2014-12 requires that a performance target that affects vesting, and that could be achieved after the requisite service period, be treated as a performance condition. As such, the performance target should not be reflected in estimating the grant date fair value of the award. ASU 2014-12 is effective for reporting periods beginning after December 15, 2015. Early adoption is permitted. The Company is evaluating the impact that adoption of this guidance will have on the determination or reporting of its financial results.

In August 2014, the FASB issued ASU 2014-15, “Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern,” (“ASU 2014-15”). ASU 2014-15 requires management to perform interim and annual assessments of an entity’s ability to continue as a going concern for a one year period subsequent to the date of the financial statements. An entity must provide certain disclosures if conditions or events raise substantial doubt about the entity’s ability to continue as a going concern. The guidance is effective for all entities for the first annual period ending after December 15, 2016 and interim periods thereafter, with early adoption permitted. The Company is evaluating the impact that adoption of this guidance will have on the determination or reporting of its financial results.

In April 2015, the FASB issued ASU 2015-03, “Imputation of Interest: Simplifying the Presentation of Debt Issuance Costs,” (“ASU 2015-03”). ASU 2015-03 requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The guidance is effective for reporting periods beginning after December 15, 2015 and interim periods within those fiscal years with early adoption permitted. ASU 2015-03 should be applied on a retrospective basis, wherein the balance sheet of each period presented should be adjusted to reflect the effects of adoption. The Company is evaluating the impact that adoption of this guidance will have on the determination or reporting of its financial results.

In July 2015, the FASB issued ASU 2015-11, “Simplifying the Measurement of Inventory,” (“ASU 2015-11”). ASU 2015-11 requires inventory be measured at the lower of cost and net realizable value and options that currently exist for market value be eliminated. ASU 2015-11 defines net realizable value as estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The guidance is effective for reporting periods beginning after December 15, 2016 and interim periods within those fiscal years with early adoption permitted. ASU 2015-11 should be applied prospectively. The Company is evaluating the impact adoption of this guidance will have on determination or reporting of its financial results.

 9 
 

Except as noted above, the guidance issued by the FASB during the current year is not expected

Stock Based Compensation

The Company records compensation expense related to have a material effectoptions granted to non-employees based on the fair value of the award.

Compensation cost is recorded as earned for all unvested stock options outstanding at the beginning of the first year based upon the grant date fair value estimates, and for compensation cost for all share-based payments granted or modified subsequently based on fair value estimates.

For the six months ended June 30, 2016 and 2015 share-based compensation for options attributable to employees, officers and Board members were approximately $53,000 and $529,000. These amounts have been included in the Company’s consolidated financial statements.statements of operations. Compensation costs for stock options which vest over time are recognized over the vesting period. As of June 30, 2016, the Company had approximately $150,000 of unrecognized compensation costs related to granted stock options that will be recognized over the remaining vesting period of approximately three years.

 

3.   FAIR VALUE OF FINANCIAL INSTRUMENTS

 

The guidance for fair value measurements, ASC820,Fair Value Measurements and Disclosures, establishes the authoritative definition of fair value, sets out a framework for measuring fair value, and outlines the required disclosures regarding fair value measurements. Fair value is the price that would be received to sell an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. The Company uses a three-tier fair value hierarchy based upon observable and non-observable inputs as follow:

 

·Level 1 – Quoted market prices in active markets for identical assets and liabilities;

·Level 2 – Inputs, other than level 1 inputs, either directly or indirectly observable; and

·Level 3 – Unobservable inputs developed using internal estimates and assumptions (there is little or no market date) which reflect those that market participants would use.

 

The Company records its derivative activities at fair value, which consisted of warrants as of SeptemberJune 30, 2015.2016. The fair value of the warrants was estimated using a Monte Carlothe Binomial Simulation and or Binomial model. Gains and losses from derivative contracts are included in net gain (loss) from derivative contracts in the statement of operations. The fair value of the Company’s derivative warrants is classified as a Level 3 measurement, since unobservable inputs are used in the valuation.

 

The following table presents the fair value for those liabilities measured on a recurring basis as of SeptemberJune 30, 20152016 and December 31, 2014:2015:

 

FAIR VALUE MEASUREMENTS (In Thousands)

The following is summary of items that the Company measures at fair value on a recurring basis:

 

 Fair Value at June 30, 2016
                
 Fair Value at September 30, 2015  Level 1  Level 2  Level 3  Total 
  

Level 1

 
   

Level 2

 
   

Level 3

 
   

Total

 
          
Warrants issued in connection with the issuance of Series C preferred stock $—    $—    $1,287  $1,287  $         -  $-  $(1) $(1)
                
Total long-term liabilities at fair value $—    $—    $1,287  $1,287 
12                
                
 Fair Value at December 31, 2014
  

Level 1

 
   

Level 2

 
   

Level 3

 
   

Total

 
 
Warrants issued in connection with the December 2014 public offering of common stock $—    $—    $(587) $(587)
Warrants issued in connection with the issuance of Series B preferred stock  —     —     (1,483)  (1,483)
Warrants issued in connection with Senior Secured Debt - - (1,376) (1,376)
Warrants to be issued in connection with distributor debt  -  -  (114)  (114)
                         
Total long-term liabilities at fair value $—    $—    $(2,070) $(2,070) $- $- $(1,491) $(1,491)
                         

 

 10 
 
  

 

 

Fair Value at December 31, 2015

         
   Level 1   Level 2   Level 3   Total 
                 
Warrants issued in connection with the issuance of Series C preferred stock $—    $—    $(1,145) $(1,145)
Warrants issued in connection with the issuance of Series B preferred stock  —     —     (1,461)  (1,461)
                 
            Total long-term liabilities at fair value $—    $—    $(2,606) $(2,606)
                 

 

The following is a summary of changes to Level 3 instruments during the ninesix months ended SeptemberJune 30, 2015:2016: 

 

  

Fair Value Measurements Using Significant Unobservable

Inputs (Level 3)

   

Series C

Warrants 

   

Series B

Warrants

   

Senior

Secured Debt

   

Distributor

Debt

   Total 
                     
Balance, December 31, 2015 $(1,145) $(1,461) $ $ –  $(2,606)
Warrants issued during the period    –    (377)  (114) (491)
Change in fair value during the period  1,144   1,461  (999)   –   1,606 
                     
Balance, June 30, 2016 $(1) $ $(1,376) $(114) $(1,491)

 

  

Fair Value Measurements Using Significant Unobservable

Inputs (Level 3)

         
   December 2014 Public Offering Warrants   Series B Warrants   Series C Warrants   Total 
                 
Balance, December 31, 2014 $(587) $(1,483) $—    $(2,070)
                 
Warrants issued during the period  —     —     (1,349)  (1,349)
Change in fair value during the period  267   381   62  710 

    Transfer to equity as a result of changes

         to provisions

  320   1,102   —     1,422 
                 
Balance, September 30, 2015 $—    $—    $(1,287) $(1,287)

As of June 30, 2016, the fair value of warrants was approximately $1.5 million. A net change of approximately $1.6 million has been recorded to the accompanying statement of operations for the six months ended.

 

4.  STOCKHOLDERS’ DEFICIT

 

Common Stock

 

At September 30, 2015 theThe Company hadhas authorized 500 million1,000,000,000 shares of common stock with $0.001 par value, of which 143.6 million84,952,126 were issued and outstanding.outstanding as of June 30, 2016. For the year ended December 31, 2014,2015, there were 195 million1,000,000,000 authorized shares of common stock, of which 96.9 million2,371,017 were issued and outstanding.

On November 12, 2015,February 24, 2016, the Company amendedimplemented a 1:100 reverse stock split of all of its certificateissued and outstanding common stock. As a result of incorporationthe reverse stock split, every 100 shares of issued and outstanding common stock of the Company were converted into 1 share. All fractional shares created by the reverse stock split were rounded to increase the nearest whole share. The number of the authorized shares of common stock by 500 million shares, to 1 billion. See Note 10, “Subsequent Events”.did not change.

 

For the ninesix months ended SeptemberJune 30, 2015,2016, the Company issued 46,791,64482,581,109 shares of common stock as listed below:

 

New issuance - for cashSeries C Preferred Stock Conversions 3,999,99929,805,879
Series C Preferred stock converted into common stock25,280,399
Stock Dividends 628,56420,808,541
Options exercisedCommon Stock Issued as Payment for Accrued Dividends 168,55830,745
Issued for professional servicesConvertible Debt Conversions 3,669,7255,226,903
Warrants conversionSeries C Exchanges 1,350,00018,396,800
Loan re-structuringSeries B Tranche B Warrants Exchanges 2,670,4088,312,241
Repayment of loan9,023,991
Total 46,791,64482,581,109

11

 

Preferred Stock

 

The Company has authorized 5,000,000 shares of preferred stock with a $.001 par value. The board of directors has the authority to issue these shares and to set dividends, voting and conversion rights, redemption provisions, liquidation preferences, and other rights and restrictions. The board of directors designated 525,000 shares of preferred stock as redeemable convertible preferred stock, none of which remain outstanding, 3,000 shares of preferred stock as Series B Convertible Preferred Stock, none of which none and 1,277 shares were issued andremained outstanding, at September 30, 2015 and December 31, 2014, respectively; and 9,000 shares of preferred stock as Series C Convertible Preferred Stock, of which 5,8942,188 and 0 shares5,555 were issued and outstanding at SeptemberJune 30, 20152016 and December 31, 2014, respectively.

2015, respectively, and 20,250 shares of Series BC1 Convertible Preferred Stock,

Pursuant to the terms of the Series B Preferred Stock set forth in the Series B designations, shares of Series B Preferred Stockwhich 4,312 and none were convertible into common stock by their holderissued and outstanding at any time, and were mandatorily convertible upon the achievement of certain conditions, including the receipt of certain approvals from the U.S. Food and Drug Administration and the achievement by the Company of specified average trading prices and volumes for the common stock.

11

Holders of the Series B Preferred Stock were entitled to quarterly dividends at an annual rate of 10.0%, payable in cash or, subject to certain conditions, common stock, at the Company’s option. Accrued dividends totaled approximately $121,600 at September 25, 2015, the last day on which any shares of Series B Preferred Stock were outstanding. At September 30, 2015, this amount was recorded in accrued liabilities on the balance sheet. Each share of Series B Preferred Stock is entitled to a number of votes equal to the number of shares of common stock into which the Series B Preferred Stock is convertible.

The Series B Preferred Stock was originally issued with Tranche A warrants to purchase 1,858,089 shares of common stock and Tranche B warrants purchasing 1,858,088 shares of common stock, both at an exercise price of $1.08 per share.

On June 30, 2016 and December 31, 2015, as consideration for obtaining consents to an amendment to the Series B designations, the Company reduced the exercise price of the Tranche A warrants from $1.08 to $0.10455 per share, and the exercise price of the Tranche B warrants from $0.10455 to $0.09 per share. The change in exercise price of these warrants resulted in a deemed dividend totaling $72,000 that has been recorded as an increase to additional paid-in capital with an offsetting charge to retained earnings. The deemed dividend has been subtracted from income (added to the loss) in computing loss per common stockholder.

At September 30, 2015, as a result of the operation of certain anti-dilution provisions, the Tranche B warrants were convertible into 17,557,468 shares of common stock. Prior to the June 2015 amendment to the Series B designations, the Company was required to account for the Tranche B warrants as a liability at fair value each reporting period. However, as a result of the June 2015 amendment, the Company transferred these warrants from a liability to equity.respectively.

 

Series C Convertible Preferred Stock

On June 29, 2015, the Company entered into a securities purchase agreement with certain accredited investors for the issuance and sale of an aggregate of 6,737 shares of Series C convertible preferred stock, at a purchase price of $750 per share and an initiala stated value per share of $1,000 subject to adjustment for stock splits, stock dividends or other similar occurrences.

per share. On September 22, 2015, the remaining balance of 1,277 Series B Preferred shares issued and outstanding were converted into the Company’s Series C Preferred shares.  On that day, 1,702 shares of Series C  Preferred were issued to replace the Series B Preferred shares.  Furthermore, 28,973,684 warrants to purchase the Company’s common stock at $0.095 per share, were issued as part of the conversion.

Pursuant to the agreement, as of September 30,3, 2015 the Company had issued 5,894 sharesentered into an interim agreement amending the securities purchase agreement to provide for certain of Series C preferred stock and warrantsthe investors to purchase 108,984,210 sharesan additional aggregate of common stock at $0.095 per share for gross proceeds totaling $3,800,500.1,166 shares. Total cash and non-cash expenses were valued at $685,500,$853,000, resulting in net proceeds of $3,115,000.$3,698,000.

The Company has provisionally allocated net proceeds totaling $935,200Pursuant to the fair valueSeries C certificate of designations, shares of Series C preferred stock are convertible into common stock by their holder at any time, and may be mandatorily convertible upon the preferredachievement of specified average trading prices for the Company’s common stock. The effectiveAt June 30, 2016, there were 2,188 shares outstanding with a conversion price of $935,000 allocated$0.017824 per share, such that each share of Series C preferred stock would convert into approximately 122,755,835 shares of the Company’s common stock, subject to customary adjustments, including for any accrued but unpaid dividends and pursuant to certain anti-dilution provisions, as set forth in the Series C certificate of designations. The conversion price will automatically adjust downward to 80% of the then-current market price of the Company’s common stock 15 trading days after any reverse stock split of the Company’s common stock, and 5 trading days after any conversions of the Company’s outstanding convertible debt.

Holders of the Series C preferred stock resultedare entitled to quarterly cumulative dividends at an annual rate of 12.0% until 42 months after the original issuance date (the “Dividend End Date”), payable in an associated beneficialcash or, subject to certain conditions, the Company’s common stock. In addition, upon conversion feature totaling $148,000 that has been recorded as an increase to additional paid-in capital with an offsetting charge to retained earnings representing a deemed dividend. The deemed dividend has been subtracted from income (addedof the Series C Preferred Stock prior to the loss) in computing loss perDividend End Date, the Company will also pay to the converting holder a “make-whole payment” equal to the amount of unpaid dividends through the Dividend End Date on the converted shares. The Series C preferred stock generally has no voting rights except as required by Delaware law. Upon the Company’s liquidation or sale to or merger with another corporation, each share will be entitled to a liquidation preference of $1,000, plus any accrued but unpaid dividends.

In addition, the purchasers of the Series C preferred stock received, on a pro rata basis, warrants exercisable to purchase an aggregate of approximately 120,000 shares of Company’s common stockholder.

stock. The warrants contain anti-dilution adjustments in the event that the Company issues shares of common stock, or securities exercisable for or convertible into shares of common stock, at prices below the exercise price of such warrants. As a result of the dilutionanti-dilution protection, the Company is required to account for the warrants as a liability recorded at fair value each reporting period. At June 30, 2016, the exercise price per share was $0.017824.

On May 23, 2016, an investor canceled warrants exercisable into 722,211 common stock shares that were received in connection with the 2015 Series C financing. The same investor also transferred warrants exercisable for 120,000 common stock shares to two investors who also had participated in the 2015 Series C financing.

Series C1 Convertible Preferred Stock

Between April 27, 2016 and May 3, 2016, the Company has valued the warrants using a Binomial model and allocated $1,349,000 to the fair value of the warrants.

From the original issue date until 42 months thereafter, theentered into various agreements with certain holders of Series C preferred stock, are entitled to receive quarterly cumulative dividends at a rate per share (as a percentageincluding John Imhoff, the chairman of stated value per share) of 12% per year per share payable quarterly on each January 1, April 1, July 1 and October 1 during such period (beginning October 1, 2015) in shares of common stock (subject to certain conditions) or, at the Company’s option, in cash. In addition, upon the conversionboard of thedirectors, pursuant to which those holders separately agreed to exchange each share of Series C preferred stock (other than a forced conversion, described below) duringheld for 2.25 shares of the such period,Company’s newly created Series C1 preferred stock and 9,600 shares of the Company’s common stock (the “Series C Exchanges”). In connection with the Series C Exchanges, each holder also agreed to roll over the $1,000 stated value per share of the holder’s shares of Series C1 preferred stock into the next qualifying financing undertaken by the Company must payon a dollar-for-dollar basis and, except in the convertingevent of an additional $50,000 cash investment in the Company by the holder, to execute a “make-whole payment”customary “lockup” agreement in cash or, atconnection with the Company’s option (subject to certain conditions), shares of common stock with respect to the convertedfinancing. In total, for 1,916 shares of Series C preferred stock in an amount equal to $420 per $1,000 of stated value, lesssurrendered, the amount of any dividends already paid on suchCompany issued 4,312 shares of Series CC1 preferred stock. To the extent the Company chooses to pay any dividends or make-whole payments instock and 18,396,800 shares of common stock, suchstock. At June 30, 2016, there were 4,312 shares will be valued at 80% of then-current market price (calculated as the average daily volume weighted averageoutstanding with a conversion price of the common stock for the five consecutive trading days prior to payment). After the dividend payment period, holders$0.017824 per share, such that each share of Series C preferred stock are only entitled to receive dividends on an as-if-converted basis) with holderswould convert into approximately 241,949,057 shares of the Company’s common stock (other than dividends paid in additional shares of common stock).stock.

 12 
 

 

ExceptThe Series C1 preferred stock has terms that are substantially the same as otherwise proved by law or in the Series C designations, the Series C preferred stock, has no voting rights. The Company may not, withoutexcept that the consent of the holders of a majority of the shares of Series CC1 preferred stock then outstanding, alter or change adversely the powers, preferences or rights givendoes not pay dividends (unless and to the Series C preferred stock or alter or amend the Series C designations, create any class of stock with a liquidation preference equal or senior to the Series C preferred stock, amend the Company’s charter in any manner that adversely affects any rights of the holders of Series C preferred stock, increase the number of authorized shares of Series C preferred stock, or enter into any agreement with respect to any of the foregoing.

In the event of a liquidation, dissolution or winding-up, whether voluntary or involuntary, the holders of Series C preferred stock will be entitled to receive out of the Company’s assets an amount equal to the stated value of their shares, plus any other fees, liquidated damages or dividends then due and owingextent declared on their shares, before any distribution or payment to the holders of any junior securities.

The Series C preferred stock is convertible at any time, at the option of the holder. In addition, if the market price of the common stock for each trading day for 20 of any 30 consecutive trading-day period exceeds 250% of the highest conversion price in effect during such period, the Company may force each holder to convert allstock) or part of such holder’s shares into shares of common stock. Each share of Series C preferred stock is convertible into the number of shares of common stock equal to the quotient obtained by dividing (i) the sum of the stated value plus all accrued but unpaid dividends on such share, by (ii) the per share conversion price. The initial per share conversion price was $0.095, but it has and will automatically adjust downward to 80% of the then-current market price on each of the following dates: (1) five trading days after the effectiveness of a resale registration statement, (2) 20 trading days after the effectiveness of the registration statement and a second resale registration statement filed in connection with the second issuance of Series C preferred stock, (3) 15 trading days after any reverse stock split of the common stock, and (5) five trading days after any conversions of the Company’s outstanding convertible debt. The conversion price is subject to further adjustment under certain circumstances to protect the holders of Series C preferred stock from dilution relative to certain issuances of common stock, or securities convertible into or exercisable for shares of common stock. Subject to certain exceptions, if the Company issues shares of common stock, or such other securities, at a price per share less than the then-effective conversion price, the conversion price will be adjusted to equal such lower per share consideration.at-the-market “make-whole payments.”

Warrants

 

The following table summarizes transactions involving the Company’s outstanding warrants to purchase common stock for the quarter ended SeptemberJune 30, 2015:2016:

 

Warrants

(Underlying Shares)

Outstanding, January 1, 20152016 29,796,0722,802,384 
Issuances 375,015,896127,396,430
To be issued13,791,518 
Canceled / Expired (3,597,3128,865,621)
Exercised -(1,350,000)
Issuable and Outstanding, SeptemberJune 30, 20152016 152,224,978382,744,177 

 

The Company had the following shares reserved for the warrants as of SeptemberJune 30, 2015:2016:

 

Warrants (Underlying Shares)

Exercise Price Per Share

Expiration Date

439,883(1)$0.6800March 31, 2016
285,186(2)$1.0500November 20, 2016
1,858,089(3)$0.1045May 23, 2018
17,557,468(3)$0.0900May 23, 2018
200,000(4)$0.5000April 23, 2019
561,798(4)$0.4500May 22, 2019
184,211(5)$0.3800September 10, 2019
325,521(6)$0.4601September 27, 2019
755,344(7)$0.2812December 02, 2019
8,392,707(8)$0.0900December 02, 2020
8,392,707(8)$0.1100December 02, 2020
2,000,000(9)$0.2550March 30, 2018
1,754,737(10)$0.1188June 29, 2020
52,642,105(11)$0.0950June 29, 2020
27,368,421(12)$0.0950September 04, 2020
28,973,684(13)$0.0950September 21, 2020
526,316(14)$0.0950September 04,2020

Warrants
(Underlying Shares)

 

Exercise Price

Expiration Date

2,852(1)$105.00 per shareNovember 20, 2016
18,581(2)$10.46 per shareMay 23, 2018
6,030,282(3)$0.09375 per shareJune 14, 2021
2,000(4)$50.00 per shareApril 23, 2019
5,618(5)$45.00 per shareMay 22, 2019
1,842(5)$38.00 per shareSeptember 10, 2019
3,255(6)$46.081 per shareSeptember 27, 2019
7,553(7)$28.13 per shareDecember 2, 2019
83,927(8)$9.00 per shareDecember 2, 2020
83,927(8)$11.00 per shareDecember 2, 2020
20,000(9)$25.50 per shareMarch 30, 2018
17,547(10)$11.88 per shareJune 29, 2020
120,000(11)$0.80 per shareJune 29, 2020
115,789(12)$0.80 per shareSeptember 4, 2020
131,842(13)$0.80 per shareSeptember 21, 2020
5,163(14)$11.88 per shareSeptember 4, 2020
157,895(15)$0.80 per shareOctober 23, 2020
5,163(16)$11.88 per shareOctober 23, 2020
345,552,885(17)$0.0166 per shareJune 14, 2021
16,586,538(18)$0.0166 per shareFebruary 21, 2021
13,791,518(19)$0.0174 per shareJune 6, 2021
382,744,177   

13
 

(1)Issued in February 2014 as part of a buy-back of a minority interest in Interscan in December 2012.
(2)Issued as part of a November 2011 private placement.
(2)Issued in June 2015 in exchange for warrants originally issued as part of a May 2013 private placement.
(3)Issued in June 2015 in exchange for warrants originally issued as part of a May 2013 private placement.
(4)Issued to a placement agent in conjunction with an April 2014 private placement.
(5)Issued to a placement agent in conjunction with a September 2014 private placement.
(6)Issued as part of a September 2014 Regulation S offering.
(7)Issued to a placement agent in conjunction with a 2014 public offering.
(8)Issued in June 2015 in exchange for warrants originally issued as part of a 2014 public offering.
(9)Issued as part of a March 2015 private placement.
(10)Issued to a placement agent in conjunction with a June 2015 private placement.
(11)Issued as part of a June 2015 private placement.
(12)Issued as part of a June 2015 private placement.
(13)Issued as part of a June 2015 private placement.placement.
(14)Issued to a placement agent in conjunction with a June 2015 private placement.
(15)Issued as part of a June 2015 private placement.
(16)Issued to a placement agent in conjunction with a June 2015 private placement.
(17)Issued as part of a February 2016 private placement.
(18)Issued to a placement agent in conjunction with a February 2016 private placement.
(19)Contractually obligated to be issued pursuant to a strategic license agreement.

13

 

All outstanding warrant agreements provide for anti-dilution adjustments in the event of certain mergers, consolidations, reorganizations, recapitalizations, stock dividends, stock splits or other changes in our corporate structure. Thestructure; except for (10). In addition, warrants identifiedsubject to footnotes (3) and (11)-(13), (15), and (17) – (19) in footnote (3) to the table and having anabove are subject to “lower price issuance” anti-dilution provisions that automatically reduce the exercise price of $0.0900 per share, as well as the warrants identified(and, in footnotes (11) – (13)the cases of warrants subject to footnote (3) in the table also contain anti-dilution adjustments inabove and footnote (17), increase the event that the Company issuesnumber of shares of common stock or securities exercisable for or convertible into sharesissuable upon exercise), to the offering price in a subsequent issuance of our common stock, at prices belowunless such subsequent issuance is exempt under the exercise priceterms of suchthe warrants.

The warrants identified insubject to footnote (3) to the table and having an exercise price of $0.0900 per share are subject to a mandatory exercise provision. SubjectThis provision permits us, subject to certain limitations, we mayto require exercise of thesesuch warrants at any time following (a) the date that is the 30th day after the later of our receipt of an approvable letter from the FDA for LuViva and the date on which the common stock achieves an average market price for 20 consecutive trading days of at least $1.30 with an average daily trading volume during such 20 consecutive trading days of at least 25,000250 shares, or (b) the date on which the average market price of the common stock for 20 consecutive trading days immediately prior to the date we deliver a notice demanding exercise is at least $1.62$162.00 and the average daily trading volume of the common stock exceeds 25,000250 shares for such 20 consecutive trading days. If these warrants are not timely exercised upon demand, they will expire. Upon the occurrence of certain events, we also may be required to repurchase these warrants, as well as the warrants subject to footnote (2) in the table above.

The warrants identifiedsubject to footnote (6) in footnote (7) to the table above are also subject to a mandatory exercise provision. This provision permits us, subject to certain limitations, to require the exercise of such warrants should the average trading price of our common stock over any 30 consecutive day trading period exceed $0.9216. $92.16.

The warrants identifiedsubject to footnote (8) in note (9) to the table above are also subject to a mandatory exercise provision. InThis provision permits us, subject to certain limitations, to require exercise of 50% of the event thatthen-outstanding warrants if the trading price of our common stock is at least two times the initial warrant exercise price for any 20-day trading period, we will have the right to require the immediate exercise of 50% of the then-outstanding warrants.period. Further, in the event that the trading price of our common stock is at least 2.5 times the initial warrant exercise price for any 20-day trading period, we will have the right to require the immediate exercise of 50% of the then-outstanding warrants. Any warrants not exercised within the prescribed time periods will be canceled to the extent of the number of shares subject to mandatory exercise.

The holders of the warrants subject to footnote (3) in the table above have agreed to surrender the warrants upon consummation of this offering for new warrants exercisable for 200% of the number of shares underlying the surrendered warrants, but without certain anti-dilution protections included with the surrendered warrants.

During the quarter ended September 30, 2015,Series B Tranche B Warrants

As discussed in footnote (3), fair value measurements, these Series B Tranche B warrants were contractually agreed to between June 13, 2016 and June 14, 2016, the Company issuedentered into various agreements with holders of certain warrants, pursuant to purchase 48,555,483which each holder separately agreed to exchange warrants for either (1) shares of common stock at an exercise priceequal to 166% of $0.09 per share and warrants to purchase 8,392,707the number of shares of common stock atunderlying the surrendered warrants, or (2) new warrants exercisable for 200% of the number of shares underlying the surrendered warrants, but without certain anti-dilution protections included with the surrendered warrants. In total, for surrendered warrants then-exercisable for an exercise priceaggregate of $0.11 per share in exchange for existing outstanding warrants to purchase 8,392,70794,825,888 shares of common stock (but subject to exponential increase upon operation of certain anti-dilution provisions), the Company issued or is obligated to issue 13,517,342 shares of common stock and new warrants that, if exercised as of the date hereof, would be exercisable for an aggregate of 173,365,822 shares of common stock. As of June 30, 2016, the Company had issued 8,312,241 shares of common stock and rights to common stock shares for 5,205,101. In certain circumstances, in lieu of presently issuing all of the shares (for each holder that opted for shares of common stock), the Company and the holder further agreed that the Company will, subject to the terms and conditions set forth in the applicable warrant exchange agreement, from time to time, be obligated to issue the remaining shares to the holder. No additional consideration will be payable in connection with the issuance of the remaining shares. The holders that elected to receive shares for their surrendered warrants have agreed that they will not sell shares on any trading day in an amount, in the aggregate, exceeding 20% of the composite aggregate trading volume of the common stock for that trading day. The holders that elected to receive new warrants will be required to surrender their old warrants upon consummation of the Company’s next financing resulting in net cash proceeds to the Company of at least $1 million. The new warrants will have an initial exercise price equal to the exercise price of $0.225 per share. Thesethe surrendered warrants are identified in footnote (8)as of immediately prior to the table. This exchange resulted in a deemed dividend totaling $1,042,000 that has been recorded as an increase to additional paid-in capital with an offsetting charge to retained earnings. The deemed dividend has been subtracted from income (added to the loss) in computing loss per common stockholder. In addition, the new warrants removed the provision requiring an adjusted exercise price in the eventconsummation of the Company receiving certain future FDA correspondence. Asfinancing, subject to customary “downside price protection” for as long as the Company’s common stock is not listed on a resultnational securities exchange, and will expire five years from the date of the June 2015 exchange, the Company transferred these warrants from a liability to equity.issuance.

14

 

5.   STOCK OPTIONS

 

Under the Company’s 1995 Stock Plan (the “Plan”), as of September 30, 2015, a total of 10,852,037 shares of common stock were subject to outstanding options and 2,403,182zero shares remained available for issuance. The Plan allows the issuance of incentive stock options, nonqualified stock options, and stock purchase rights. The exercise price of options is determined by the Company’s board of directors, but incentive stock options must be granted at an exercise price equal to the fair market value of the Company’s common stock as of the grant date. Options historically granted have generally become exercisable over four years and expire ten years from the date of grant. For the three and nine months ended September 30, 2015, approximately $210,000 and $592,000, respectively, was recorded in employee option expenses.

 

14

As of June 30, 2016, we have issued options to purchase a total of 98,161 shares of our common stock pursuant to our equity incentive plan, at a weighted average exercise price of $40.30 per share. Recommendations for option grants under our equity incentive plans are made by the compensation committee of our board, subject to ratification by the full board. The compensation committee may issue options with varying vesting schedules, but all options granted pursuant to our equity incentive plans must be exercised within ten years from the date of grant.

 

A summary of the Company’s activity under the Plan as of September 30, 2015 and changes during the nine months then ended is as follows:

  

 

 

 

 

Shares

 

 

Weighted

average

exercise

price

 

Weighted

average

remaining

contractual

(years)

Outstanding, January 1, 2015  6,940,395  $0.66   6.97 
Granted  4,214,000   0.11     
Exercised / Expired  (302,358)  0.60     
Outstanding, September 30, 2015  10,852,037  $0.45   6.71 
             
Vested and exercisable, September 30, 2015  9,123,067  $0.48   6.24 

The Company estimates the fair value of stock options granted in the period ended June 30, 2015 were estimated using athe Black-Scholes valuationoption pricing model. Key input assumptions used to estimateNo options were issued during the fair value of stock options include the expected term, expected volatility of the Company’s common stock, the risk free interest rate,period ended June 30, 2016. 

Stock option forfeiture rates, and dividends, if any. The expected term of the options is based upon the historical term until exercise or expiration of all granted options. The expected volatility is derived from the historical volatility of the Company’s stock on the OTCBB marketactivity for a period that matches the expected term of the option. The risk-free interest rate is the constant maturity rate published by the U.S. Federal Reserve Board that corresponds to the expected term of the option.June 30, 2016 as follows: 

  2016 
    

Weighted

Average

Exercise

 
  Shares Price 
Outstanding at beginning of year  105,936  $45.00  
   Options granted  -  $-  
   Options exercised  -  $-  
   Options expired/forfeited  (7,775) $71.16  
Outstanding at end of year  98,161  $40.30  

 

6.   LITIGATION AND CLAIMS

 

From time to time, the Company may be involved in various legal proceedings and claims arising in the ordinary course of business. Management believes that the dispositions of these matters, individually or in the aggregate, are not expected to have a material adverse effect on the Company’s financial condition. However, depending on the amount and timing of such disposition, an unfavorable resolution of some or all of these matters could materially affect the future results of operations or cash flows in a particular period.

 

As of SeptemberJune 30, 20152016 and December 31, 2014,2015, there was no accrual recorded for any potential losses related to pending litigation.

  

7.   NOTES PAYABLE

 

Short Term Notes Payable

 

At SeptemberJune 30, 20152016 and December 31, 2014,2015, the Company maintained notes payable and accrued interest to both related and non-related parties totaling $662,000$360,000 and $609,000,$682,000, respectively. These notes are short term, straight-line amortizing notes. The notes carry an annual interest rate ofrates between 0%5.0% and 10%10.0%.

 

At December 31, 2014,

15

In June 2016, the Company maintainedentered into a note payablepremium finance agreement to Premium Assignment Corporation, anfinance its insurance premium financing company, of approximately $100,000. This note was a 10 month straight-line amortizing loan dated June 24, 2014.policies totaling $172,351. The note carried annualrequires monthly payments of $17,622, including interest of 4.6%.at 4.87% and matures in April 2017. The balance due on this note totaled $172,000 at June 30, 2016.

In June 2015, the Company entered into a similar short-term note payable for the financing of its insurance policies. This note required monthly payments of $17,614, including interest at 5.2% and matured in April 2016. The balance due on this note totaled $70,000 at December 31, 2014 was approximately $37,000. The note was paid in full during the quarter ended June 30, 2015.

 

At September 30, 2015, the Company maintained a note payable to Premium Assignment Corporation, an insurance premium financing company, of approximately $172,000. These notes are 10 month straight-line amortizing loans dated June 24, 2014. The notes carry annual interest of 4.6%. The balance due to on the Premium Assignment note was approximately $122,000 at September 30, 2015.

NoteNotes Payable in Default

 

At SeptemberJune 30, 2016, and December 31, 2015 the Company maintained a notenotes payable totaling approximately $129,000 of principal and accrued interest.interest to related and unrelated parties totaling $596,000 and $133,000, respectively. The note accruesnotes carry interest at 9% with5% to 10% and have default rates as high a 16% default rate, requires monthly payments of $10,000, and matures November 2015.16.5%. As of SeptemberJune 30, 20152016 the note isnotes are accruing interest at the default rate. As of December 31, 2014 the balance was $163,000 and was not in default.

 

Short Term Convertible Note Payable8.  CONVERTIBLE DEBT

 

On September 10, 2014, the Company sold a secured promissory note to Tonaquint, Inc.,an accredited investor with an initial principal amount of $1,275,000, for a purchase price of $700,000 (an original issue discount of $560,000). The Company may prepay the note at any time. The note is secured by the Company’s current and future accounts receivable and inventory, pursuant to a security agreement entered into in connection with the sale. On March 10, 2015, May 4, 2015, June 1, 2015, June 16, 2015, and June 29, 2015, January 21, January 29 and February 12, 2016 the Company amended the terms of the note to extend the maturity ultimately until August 31, 2016. During the extension, interest accrues on the note at a rate of the lesser of 18% per year or the maximum rate permitted by applicable law. On February 11, 2016, the Company consented to an assignment of the note to two accredited investors. In connection with the assignment, the holders waived an ongoing event of default under the notes related to the Company’s minimum market capitalization, and agreed to eliminate the requirement going forward. Pursuant to the terms of the amended note, as of September 30, 2015 Tonaquint couldthe holder may convert up to $935,300 inthe outstanding balance into shares of common stock which limit increases by $75,000 monthly, at a conversion price per share equal to the lower of (1) $0.25$25.0 or (2) 75% of the lowest daily volume weighted average price of the common stock during the five days prior to conversion. If the conversion price at the time of any conversion is lower than $0.15,$15.00, the Company has the option of delivering the conversion amount in cash in lieu of shares of common stock. AsOn March 7, 2016, the Company further amended the notes to eliminate the volume limitations on sales of Septembercommon stock issued or issuable upon conversion of the notes.

The balance due related to this note was $516,244 and $685,864 at June 30, 2016 and December 31, 2015, respectively.

Total debt issuance costs originally capitalized was approximately $130,000. This amount was being amortized over six months and was fully amortized as of June 30, 2015. Total amortized expense for the six months ended June 30, 2015 Tonaquint had converted $539,542 in outstanding principal and accrued interest into 9,023,991 shares of common stock. The Company paid Tonaquint a total of $65,000 in loan modification fees. At Septemberwas approximately $49,000. For the six months ended June 30, 2015, the balanceCompany recorded amortization of approximately $213,000 on the note was approximately $935,300.discount.  The original issue discount of $560,000 was fully amortized as of June 30, 2015.

 

On June 5, 2016, the Company entered into a license agreement with a distributor pursuant to which the Company granted the distributor an exclusive license to manufacture, sell and distribute the Company’s LuViva Advanced Cervical Cancer device and related disposables in Taiwan, Brunei Darussalam, Cambodia, Laos, Myanmar, Philippines, Singapore, Thailand, and Vietnam. The distributor is currently is the Company’s exclusive distributor in China, Macau and Hong Kong, and the license will extend to manufacturing in those countries as well.

As partial consideration for, and as a condition to, the license, and to further align the strategic interests of the parties, the Company agreed to issue a convertible note to the distributor, in exchange for an aggregate cash investment of $200,000. The note will provide for a payment to the distributor of $240,000, due upon consummation of any capital raising transaction by the Company within 90 days and with net cash proceeds of at least $1.0 million. Absent such a transaction, the payment will increase to $300,000 and will be payable by December 31, 2016. The note will accrue interest at 20% per year on any unpaid amounts due after that date. The note will be convertible into shares of the Company’s common stock at a conversion price per share of $0.017, subject to customary anti-dilution adjustment. The note will be unsecured, and is expected to provide for customary events of default. The Company will also issue the distributor a five-year warrant exercisable immediately for 13.8 million shares of common stock at an exercise price equal to the conversion price of the note, subject to customary anti-dilution adjustment.

The Company allocated proceeds of $114,000 to the fair value of the warrants for a remaining balance of $86,000 related to the convertible note at June 30, 2016. The discount of $154,000 will be amortized over 90 days.

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8. CONVERIBLE9.  CONVERTIBLE DEBT IN DEFAULT

 

On April 23, 2014,February 11, 2016, the Company entered into a securities purchase agreement with Magna Equities II, LLC (formerly Hanover Holdings I, LLC), an affiliateaccredited investor for the issuance and sale on February 12, 2016 of Magna Group (“Magna”), pursuant to which the Company sold Magna a 6% senior convertible note with an initial$1.4375 million in aggregate principal amount of $1.5 million anda senior secured convertible note for an 18-month term, for aaggregate purchase price of $1.0$1.15 million (an approximately 33.3%(a 20% original issue discount). Additionally, pursuantdiscount of $287,500) and a discount for debt issuance costs paid at closing of $121,000 for a total of $408,500. In addition, the investor received a warrant exercisable to purchase an aggregate of approximately 1,796,875 million shares of the Company’s common stock. The Company allocated proceeds totaling $359,555 to the purchase agreement, on May 23, 2014 Magna purchasedfair value of the warrants at issuance. This was recorded as an additional seniordiscount on the debt. The convertible note withmatures on the second anniversary of issuance and, in addition to the 20% original issue discount, accrues interest at a rate of 17% per year. The Company will pay monthly interest coupons and, beginning six months after issuance, will pay amortized quarterly principal payments. If the Company does not receive, on or before the first anniversary after issuance, an initial principal amountaggregate of $2.0at least $3.0 million and an 18-month term, for a fixed purchase pricefrom future equity or debt financings or non-dilutive grants, then the holder will have the option of $2.0 million. Asaccelerating the maturity date to the first anniversary of September 30, 2015 and December 31, 2014,issuance. The Company may prepay the outstanding balance was zero and $783,000, respectively. As of July 1, 2015, the notes were repaidconvertible note, in full.

whole or in part, without penalty, upon 20 days’ prior written notice. Subject to certain limitations,resale restrictions under Federal securities laws and the notes wereavailability of sufficient authorized but unissued shares of the Company’s common stock, the convertible note is convertible at any time, in whole or in part, at Magna’sthe holder’s option, into shares of the Company’s common stock, at a conversion price equal to the lesser of $0.55$0.80 per share and a 25% discount from the lowest daily volume-weighted average priceor 70% of the Company’s common stock inaverage closing price per share for the five trading days prior to conversion.issuance, subject to certain customary adjustments and anti-dilution provisions contained in the convertible note. The Company is currently in default as they are past due on their required monthly interest payments. In the event of default, the Company shall accrue interest at a rate of the lesser of 22% or the maximum permitted by law. The Company has accrued $68,218 for past due interest payments at June 30, 2016. Upon the occurrence of an event of default, the holder may require the Company to redeem the convertible note at 120% of the outstanding principal balance. As of June 30, 2016, the balance due on the convertible debt was $1,830,000 as the Company has fully amortized debt issuance costs of $47,675 and the debt discount of $768,055 and recorded a 20% penalty totaling $305,000. The convertible note is secured by a lien on all of the Company’s assets, including its intellectual property, pursuant to a security agreement entered into by the Company and the accredited investor with the transaction.

On May 28, 2016, in exchange for an additional $87,500 in cash to the Company, the principal balance was increased by the same amount.

The warrant is exercisable at any time, pending availability of sufficient authorized but unissued shares of the Company’s common stock, at an exercise price per share equal to the conversion price of the convertible note, subject to certain customary adjustments and anti-dilution provisions contained in the warrant. The warrant has a five-year term. As of June 30, 2016, the exercise price had been adjusted to $0.0416 and the number of common stock shares exchangeable for was 366,586,538. As of June 30, 2016, the effective interest rate considering debt costs was 29%.

 

The Company paid to Magnaused a commitment fee for entering into the purchase agreement in the form of 321,820 shares of common stock. The Company also paid $50,000 of attorneys’ fees and expenses incurred by Magnaplacement agent in connection with the transaction. Total debt issuance costs incurred onFor its services, the Senior Convertible Note was approximately $844,000. This amount was being amortized over 18 months. Total amortization expenseplacement agent received a cash placement fee equal to 4% of the aggregate gross proceeds from the transaction and a warrant to purchase shares of common stock equal to an aggregate of 6% of the total number of shares underlying the securities sold in the transaction, at an exercise price equal to, and terms otherwise identical to, the warrant issued to the investor. Finally, the Company agreed to reimburse the placement agent for the three and nine months ended September 30, 2015 was approximately $234,500 and $516,000, respectivelyits reasonable out-of-pocket expenses.

 

In connection with the transaction, on February 12, 2016, the Company and the investor entered into a four-year consulting agreement, pursuant to which the investor will provide management consulting services to the Company in exchange for a royalty payment, payable quarterly, equal to 3.5% of the Company’s revenues from the sale of products. As of June 30, 2016 the convertible notes, the Company issued its placement agent warrants exercisable for 200,000 sharesinvestor had earned approximately $13,000 of common stock at $0.50 per share with an expiration date of April 23, 2019, and warrants exercisable for 561,798 shares of common stock at $0.45 per share with an expiration date of May 22, 2019.royalties.

 

As of September 30, 2015, the Company had issued a total of 25,280,399 shares of common stock in conjunction with conversions of the convertible notes.

9. LOSS10.  INCOME (LOSS) PER COMMON SHARE

 

Basic net lossincome (loss) per share attributable to common stockholders amounts are computed by dividing the net lossincome (loss) plus preferred stock dividends and deemed dividends on preferred stock by the weighted average number of shares outstanding during the period.

 

Diluted net income (loss) per share attributable to common stockholders amounts are computed by dividing the net income (loss) plus preferred stock dividends, deemed dividends on preferred stock, after-tax interest on convertible debt and convertible dividends by the weighted average number of shares outstanding during the period, plus Series C convertible preferred stock, convertible debt, convertible preferred dividends and warrants convertible into common stock shares.

 

 1617 
 

 

 

10.11.  SUBSEQUENT EVENTS

 

On November 11, 2015,July 13, 2016, the Company held a special meeting of stockholders at its office in Norcross, Georgia. Atconsented to the special meeting the Company’s stockholders approved an amendment to its certificate of incorporation to (i) increase the number of authorized sharesassignment of the Company’s common stockconvertible debt by one of the accredited investors of its portion of the note to a total of 1,000,000,000 shares and (ii) to allow the Company’s board of directors to effect a reverse stock split at any time prior to November 11, 2018, in a ratio ranging from 1-for-10 to 1-for-100, of all issued and outstanding shares of the Company’s common stock. On November 12, 2015, the Company amended its certificate of incorporation to increase the number of authorized shares of its common stock by 500,000,000 shares to 1,000,000,000.third accredited investor.

18

 

ITEM 2.  MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

Statements in this report which express "belief," "anticipation" or "expectation," as well as other statements which are not historical facts, are forward-looking statements. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from historical results or anticipated results, including those that may be set forth under "Risk Factors" below and elsewhere in this report, as well as in our annual report on Form 10-K for the year ended December 31, 20142015 and subsequently filed quarterly reports on Form 10-Q. Examples of these uncertainties and risks include, but are not limited to:

·

access to sufficient debt or equity capital to meet our operating and financial needs;

·the extent of dilution of the holdings of our existing stockholders upon the issuance, conversion or exercise of securities issued as part of our capital raising efforts;;
·the effectiveness and ultimate market acceptance of our products;products and our ability to generate sufficient sales revenues to sustain our growth and strategy plans;
·whether our products in development will prove safe, feasible and effective;
·whether and when we or any potential strategic partners will obtain approval fromrequired regulatory approvals in the FDA and corresponding foreign agencies;markets in which we plan to operate;
·our need to achieve manufacturing scale-up in a timely manner, and our need to provide for the efficient manufacturing of sufficient quantities of our products;
·the lack of immediate alternate sources of supply for some critical components of our products;
·our ability to establish and protect the proprietary information on which we base our products, including our patent and intellectual property position;
·the need to fully develop the marketing, distribution, customer service and technical support and other functions critical to the success of our product lines;
·the dependence on potential strategic partners or outside investors for funding, development assistance, clinical trials, distribution and marketing of some of our products; and
·other risks and uncertainties described from time to time in our reports filed with the SEC.

 

The following discussion should be read in conjunction with our financial statements and notes thereto included elsewhere in this report.

 

OVERVIEW

 

We are a medical technology company focused on developing innovative medical devices that have the potential to improve healthcare. Our primary focus is the commercializationsales and marketing of our LuViva® Advanced Cervical Scan non-invasive cervical cancer detection device. OurThe underlying technology including products in research and development,of LuViva primarily relates to the use of biophotonics technology for the non-invasive detection of cancers. LuViva is designed to identify cervical cancers and precancers painlessly, non-invasively and at the point of care by scanning the cervix with light, then analyzing the reflected and fluorescent light.

 

LuViva provides a less invasive and painless alternative to conventional tests for cervical cancer screening and detection. Additionally, LuViva improves patient well-being not only because it eliminates pain, but also because it is convenient to use and provides rapid results at the point of care. We focus on two primary applications for LuViva: first, as a cancer screening tool in the developing world, where infrastructure to support traditional cancer-screening methods is limited or non-existent, and second, as a triage following traditional screening in the developed world, where a high number of false positive results cause a high rate of unnecessary and ultimately costly follow-up tests.

We are a Delaware corporation, originally incorporated in 1992 under the name “SpectRx, Inc.,” and, on February 22, 2008, changed our name to Guided Therapeutics, Inc. At the same time, we renamed our wholly owned subsidiary, InterScan, which originally had been incorporated as “Guided Therapeutics.”

Since our inception, we have raised capital through the public and private sale of preferred stockdebt and debt securities, public and private sales of common stock,equity, funding from collaborative arrangements, and grants.

  

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Our prospects must be considered in light of the substantial risks, expenses and difficulties encountered by entrants into the medical device industry. This industry is characterized by an increasing number of participants, intense competition and a high failure rate. We have experienced netoperating losses since our inception and, as of SeptemberJune 30, 2015,2016 we have an accumulated deficit of about $120.0approximately $125.1 million. Through September 30, 2015,To date, we have engaged primarily in research and development efforts and the early stages of marketing our products. We do not have significant experience in manufacturing, marketing or selling our products. We may not be successful in growing sales for our products. Moreover, we may not obtain required regulatory clearances or approvals.approvals may not be obtained in a timely manner, or at all. Our products may not ever gain market acceptance and we may not ever generate significant revenues or achieve profitability. The development and commercialization of our products requires substantial development, regulatory, sales and marketing, manufacturing and other expenditures. We expect our operating losses to continue through at least the end of 20152016 as we continue to expend substantial resources to introduce LuViva,complete commercialization of our products, obtain regulatory clearances or approvals, build our marketing, sales, manufacturing and finance organizationscapabilities, and conduct further research and development.

Our product revenues to date have been limited. In 2013, the majority of our revenues were from grants from the NCI and NIH and revenue from the sale of LuViva devices. In 2014,2015, the majority of our revenues were from the sale of LuViva devices and disposables, as well as some revenue from grants from the NIH and licensing agreement fees.fees received. We expect that the majority of our revenue in 20152016 will be derived from revenue from the sale of LuViva devices and disposables.

CRITICAL ACCOUNTING POLICIES

 

Our material accounting policies, which we believe are the most critical to an investors understanding of our financial results and condition, are discussed below. Because we are still early in our enterprise development, the number of these policies requiring explanation is limited. As we begin to generate increased revenue from different sources, we expect that the number of applicable policies and complexity of the judgments required will increase.

 

Currently, our policies that could require critical management judgment are in the areas of revenue recognition, reserves for accounts receivable and inventory valuation.

Revenue Recognition:We recognize revenue from contracts on a straight line basis, over the terms of the contract. We recognize revenue from grants based on the grant agreement, at the time the expenses are incurred. Revenue from the sale of the Company’s products is recognized upon shipment of such products to its customers.

Valuation of Deferred Taxes:We account for income taxes in accordance with the liability method. Under the liability method, we recognize deferred assets and liabilities based upon anticipated future tax consequences attributable to differences between financial statement carrying amounts of assets and liabilities and their respective tax bases. We establish a valuation allowance to the extent that it is more likely than not that deferred tax assets will not be utilized against future taxable income.

Stock Option Plan:We measure the costValuation of employees services received in exchange for equity awards, including stock options, based on the grant date fair value of the awards. The cost will be recognized as compensation expense over the vesting period of the awards.

Warrants:The Company has issued warrants, which allow the warrant holderEquity Instruments Granted to purchase one share of stock at a specified price for a specified period of time. The Company records equity instruments including warrants issued to non-employees based on the fair value at the date of issue. The fair value of warrants classified as equity instruments atEmployee, Service Providers and Investors: On the date of issuance, is estimated using the Black-Scholes Model. Theinstruments are recorded at their fair value of warrants classified as liabilities at the date of issuance is estimateddetermined using either the Black-Scholes valuation model or Monte Carlo Simulation model or a Binomial model.

Allowance for Inventory Valuation: We estimate losses from obsolete and damaged inventories quarterly and revise our reserves as a result. Since See Note 4 to the inventory is stated at the lower of cost or market, we also estimated an allowanceconsolidated financial statements accompanying this report for the potential losses onassumptions used in the sale of inventory.

Black-Scholes valuation.

Allowance for Accounts Receivable:We estimate losses from the inability of our customers to make required payments and periodically review the payment history of each of our customers, as well as their financial condition, and revise our reserves as a result.

Inventory Valuation: All inventories are stated at lower of cost or market, with cost determined substantially on a “first-in, first-out” basis. Selling, general, and administrative expenses are not inventoried, but are charged to expense when purchased.

Debt Issuance:Reverse Stock Split: Debt issuance costs incurred in securing the Company’s financing arrangements are capitalizedOn February 24, 2016, we implemented a 1:100 reverse stock split of all of our issued and amortized over the termoutstanding common stock. As a result of the debt. Deferred financing costs are included in other long term assets.

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reverse stock split, every 100 shares of issued and outstanding common stock was converted into 1 share of common stock. All fractional shares created by the reverse stock split were rounded to the nearest whole share. The number of authorized shares of common stock did not change. (unless otherwise indicated, all per share amounts reported on a post-split basis)

 

RECENT DEVELOPMENTS

 

On November 11, 2015, we held a special meeting of stockholders at our office in Norcross, Georgia. At the special meeting our stockholders approved an amendment to our certificate of incorporation to (i) increase the number of authorized shares of the our common stock to a total of one billion shares and (ii) to allow the our board of directors to effect a reverse stock split, in a ratio ranging from 1-for-10 to 1-for-100, of all issued and outstanding shares of our common stock, at any time prior to November 11, 2018. Shortly after the meeting,July 1, 2016, we filed a registration statement for the amendmentpurposes of attempting to our certificate of incorporation to increase the number of authorized shares of our common stock to one billion.raise $5.0 million by issuing Series D Preferred Stock and Warrants.

On November 5, 2015, we announced that the FDA set a new meeting date of November 30, 2015, to review our plan to submit an approvable application for LuViva®.

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RESULTS OF OPERATIONS

 

COMPARISON OF THE THREE MONTHS ENDED SEPTEMBERJUNE 30, 20152016 AND 2014

Sales Revenue, Cost of Goods Sold and Gross Loss from Devices and Disposables: Sales revenue from the sale of LuViva devices and disposables for the three months ended September 30, 2015 was approximately $94,000. Related costs of goods sold were approximately $230,000, which resulted in a gross loss for the device and disposables of approximately $136,000. For the same period last year, sales revenue from the sale of LuViva devices and disposables was approximately $262,000 and related costs of goods sold were approximately $260,000, which resulted in a gross profit on the device and disposables of approximately $2,000.

Contract Revenue:  Contract revenue decreased to approximately $8,000 for the quarter ended September 30, 2015, from approximately $22,000 for the same period in 2014.

Research and Development Expenses:  Research and development expenses decreased to approximately $413,000 for the three months ended September 30, 2015, compared to $892,000 for the same period in 2014.  The decrease, of approximately $479,000, was primarily due to a shift of resources toward marketing and production.

Sales and Marketing Expenses:  Sales and marketing expenses were approximately $187,000 during the three months ended September 30, 2015, compared to $135,000 for the same period in 2014. The increase was primarily due to expenses related to promoting LuViva, at key international events.

General and Administrative Expenses:  General and administrative expenses decreased to approximately $1.1 million during the three months ended September 30, 2015, compared to approximately $1.4 million for the same period in 2014.  The decrease, of approximately $302,000 or 21.4%, is primarily related to the Company wide expense reduction program.

Other Income: Other income for the three months ended September 30, 2015, was approximately $10,000, compared to other income of approximately $9,000 for the three months ended September 30, 2014.

Change in Fair Value of Warrants Expense: Change in fair value of warrants was a recovery of approximately $41,000, for this quarter ended, September 30, 2015, due to reclassification of some derivatives from debt to equity; as compared to approximately $195,000 expense for the same period in 2014.

Interest Expense:  Interest expense increased to approximately $404,000 for the three months ended September 30, 2015, as compared to approximately $371,000 for the same period in 2014, primarily due to higher principal amounts of outstanding indebtedness for the quarter ended September 30, 2015.

Net loss was approximately $2.2 million during the three months ended September 30, 2015, compared to $3.0 million for the same period in 2014, for the reasons outlined above.

COMPARISON OF THE NINE MONTHS ENDED SEPTEMBER 30, 2015 AND 2014

 

Sales Revenue, Cost of Sales and Gross Loss from Devices and Disposables: Sales revenue from the sale of LuViva devices and disposables for the ninethree months ended SeptemberJune 30, 20152016, was approximately $323,000.$129,000, a 25% increase compared to the same period in 2015. Related costs of sales and net realizable value expenses and variances adjustmentsfor the three months ended June 30, 2016, were approximately $544,000,$33,000, which resulted in a gross profit of approximately $96,000. Sales revenue for the three months ended June 30, 2015, was approximately $103,000. Related costs of sales in that period were approximately $207,000, which resulted in a gross loss on the device and disposables of approximately $221,000. Sales revenue from the sale of LuViva devices and disposables for the nine months ended September 30, 2014, was approximately $586,000. Related costs of sales were approximately $723,000, which resulted in a gross loss on the device and disposables of approximately $137,000.

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Contract and Grant Revenue:  Contract and grant revenue decreased to approximately $33,000 for the nine months ended September 30, 2015, from approximately $52,000 for the same period in 2014. Contract and grant revenue was lower for the current period due primarily to lower royalty receipts$104,000. The increase in the nine months then endedsecond quarter of 2016 as compared to the same period in 2014.second quarter of 2015 was related to additional sales of devices and disposables and reduction of absorption costs.

 

Research and Development Expenses:  Research and development expenses decreased to approximately $1.1 million$148,000 for the ninethree months ended SeptemberJune 30, 2015,2016, compared to $2.1 million$305,000 for the same period in 2014.2015.  The decrease, of approximately $1.0 million,$157,000, or 51.0%, was primarily due to a decreasedecreases in expenses associated with our esophageal cancer technologyresearch and our ongoing shift toward production of LuViva devices.development payroll expenses.

 

Sales and Marketing Expenses:  Sales and marketing expenses were approximately $542,000$86,000 during the ninethree months ended SeptemberJune 30, 2015,2016, compared to $762,000$183,000 for the same period in 2014.2015. The decrease, of approximately $97,000, or 53.0%, was primarily due to the Company-wide expense reduction and cost savings efforts.

 

General and Administrative Expenses:  General and administrative expenses decreased to approximately $2.9 million$760,000 during the ninethree months ended SeptemberJune 30, 2015,2016, compared to approximately $3.6 million$1,019,000 for the same period in 2014.2015.  The decrease of approximately $688,000,$259,000, or 19.4%25.0%, iswas primarily related to lower payroll expensecompensation and option expenses incurred during the same period, as well as the ongoing Company-wide expense reduction program.period.

 

Other Income: Other income for the ninethree months ended SeptemberJune 30, 2015,2016, was approximately $69,000,$21,000, compared to other income of approximately $14,000$284,000 for the ninethree months ended SeptemberJune 30, 2014.

Change in Fair Value of Warrants Expense: Change in fair value of warrants was a recovery2015. The decrease, of approximately $690,000 for the nine months ended September 30, 2015,$263,000, or 93.0%, was primarily due to reclassification$230,000 of some derivatives from debt to equity, as compared to approximately $266,000accounts payable that were written off and $50,000 of income recorded for the same period in 2014.

a license agreement.

Interest Expense:  Interest expense increased to approximately $1.2 million$1,213,000 for the ninethree months ended SeptemberJune 30, 2015,2016, as compared to approximately $445,000$323,000 for the same period in 2014,2015. The increase, of approximately $890,000, or 276.0%, was primarily due to amortization of debt discount, and debt issuance costs.costs and penalty on event default of convertible loan that were higher than the same period in 2015.

Fair Value of Warrants (Income) Expense: Fair value of warrants expense recovery was approximately $211,000 for the three months ended June 30, 2016, as compared to a warrant expense of approximately $66,000 for the same period in 2015.

 

Net loss was approximately $5.1 million$1,879,000 during the ninethree months ended SeptemberJune 30, 2015,2016, compared to $6.7 milliona net loss of $1,706,000 for the same period in 2014,2015. The decrease in the net loss of $173,000, or 10.0%, was for the reasons outlined above.

COMPARISON OF THE SIX MONTHS ENDED JUNE 30, 2016 AND 2015

Sales Revenue, Cost of Sales and Gross Loss from Devices and Disposables: Sales revenue from the sale of LuViva devices and disposables for the six months ended June 30, 2016, was $391,000, a 71% increase compared to the same period in 2015. Related costs of sales and net realizable value expenses for the six months ended June 30, 2016 were approximately, $101,000, which resulted in a gross profit of approximately $290,000. Sales revenue for the six months ended June 30, 2015, was approximately $229,000. Related costs of sales in that period were approximately $314,000, which resulted in a gross loss on the device and disposables of approximately $85,000. The increase in the first six months of 2016 as compared to the first six months of 2015 was related to additional sales of disposables with the Company’s primary distributor, which carry a higher profit margin than device sales.

Research and Development Expenses:  Research and development expenses decreased to approximately $438,000 or the six months ended June 30, 2016, compared to $677,000 for the same period in 2015.  The decrease, of approximately $239,000, or 35.0% is primarily due to a slight decrease in payroll expenses.

Sales and Marketing Expenses:  Sales and marketing expenses were approximately $203,000 during the six months ended June 30, 2016, compared to $355,000 for the same period in 2015. The decrease, of approximately $152,000, or 43.0% was primarily due to the Company-wide expense reduction and cost savings efforts.

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General and Administrative Expenses:  General and administrative expenses decreased to approximately $1,677,000 during the six months ended June 30, 2016, compared to approximately $1,982,000 for the same period in 2015.  The decrease of approximately $305,000, or 15.0%, was primarily related to lower compensation and option expenses incurred during the same period.

Other Income: Other income for the six months ended June 30, 2016, was approximately $44,000, compared to other income of approximately $290,000 for the six months ended June 30, 2015. The decrease of approximately $246,000, or 85.0%, was primarily due to $230,000 of accounts payable that were written off and $50,000 of income recorded for a license agreement.

Interest Expense:  Interest expense increased to approximately $1,371,000 for the six months ended June 30, 2016, as compared to approximately $815,000 for the same period in 2015. The increase of approximately $556,000, or 68.0%, was primarily due to amortization of debt discount, debt issuance costs and penalty on event default of convertible loan that were higher than the same period in 2015. 

Fair Value of Warrants Expense: Fair value of warrants expense recovery was approximately $1,606,000 for the six months ended June 30, 2016, as compared to approximately $648,000 for the same period in 2015.

Net loss was approximately $1,749,000 during the six months ended June 30, 2016, compared to a net loss of $2,951,000 for the same period in 2015. The decrease in the net loss of $1,202,000, or 41.0%, was for the reasons outlined above.

 

LIQUIDITY AND CAPITAL RESOURCES

 

Since our inception, we have raised capital through the private sale of preferred stock and debt securities, public and private sales of common stock, funding from collaborative arrangements, and grants. At SeptemberJune 30, 2015,2016, we had cash of approximately $172,000$22,000 and negative working capital deficit of approximately $2.7$5.6 million.

 

Our major cash flows in the nine monthsquarter ended SeptemberJune 30, 2015,2016, consisted of cash out-flows of approximately $3.8$1.5 million from operations, including approximately $5.1 million of net loss,no cash inflow nor outflow of approximately $2,000 from investing activities and cash proceedsa net change from financing activities of $3.6,$1.5 million, which primarily represents the proceeds received from the salesissuance of privately placed securities.

In connection with a private placement to accredited investors of our Series C preferred stock, during the third quarter of 2015 we issued 3,569 shares of Series C preferred stock and warrants exercisable for 56,868,421 shares of common stock, for gross cash proceeds of $1.3 million and the cancelation of all remaining outstanding shares of our Series B preferred stock.convertible notes.

 

We will be required to raise additional funds through public or private financing, additional collaborative relationships or other arrangements, as soon as possible. We cannot be certain that our existing and available capital resources will be sufficient to satisfy our funding requirements through the fourththird quarter of 2015.2016. We are evaluating various options to further reduce our cash requirements to operate at a reduced rate, as well as options to raise additional funds, including loans. For additional information please refer to Part II, Item 1A, “Risk Factors,” contained herein.

 

Substantial capital will be required to develop our products, including completing product testing and clinical trials, obtaining all required U.S. and foreign regulatory approvals and clearances, and commencing and scaling up manufacturing and marketing our products. Any failure to obtain capital would have a material adverse effect on our business, financial condition and results of operations.

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Our financial statements have been prepared and presented on a basis assuming we will continue as a going concern.  The above factors raise substantial doubt about our ability to continue as a going concern, as more fully discussed in Note 1 to the consolidated financial statements contained herein and in the report of our independent registered public accounting firm accompanying our financial statements contained in our annual report on Form 10-K for the year ended December 31, 2014.2015.

 

Off-Balance Sheet Arrangements

 

We have no material off-balance sheet arrangements, no special purpose entities, and no activities that include non-exchange-traded contracts accounted for at fair value.

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ITEM 3.     QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable.

  

ITEM 4.   CONTROLS AND PROCEDURES

 

Disclosure Controls and Procedures

 

The Company under the supervision and with the participation of management, including the Chief Executive Officer (principal executive officer) and the Chief Financial Officer (principal financial officer), evaluated the effectiveness of our “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”)) as of SeptemberJune 30, 2015.2016. The controls and System currently used by the Company to calculate and record inventory is not operating effectively. Additionally, the Company lacks the resources to properly research and account for complex transactions. The combination of these controls deficiencies have resulted in a material weakness in our internal control over financial reporting.

Based on that evaluation, the Chief Executive Officer and the Chief Financial Officer concluded that our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) were not effective as of SeptemberJune 30, 20152016 to provide reasonable assurance that (1) information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and (2) information required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosures.

The effectiveness of any system of controls and procedures is subject to certain limitations, and, as a result, there can be no assurance that our controls and procedures will detect all errors or fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system will be attained.

Changes in Internal Control Overover Financial Reporting

There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended SeptemberJune 30, 20152016 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

  

  

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PART II - OTHER INFORMATION

 

ITEM 1.  LEGAL PROCEEDINGS

 

From time to time, the Company may be involved in various legal proceedings and claims arising in the ordinary course of business. Management believes that the disposition of these matters, individually or in the aggregate, is not expected to have a material adverse effect on the Company’s financial condition. See Note 6 to the financial statements.

 

ITEM 1A.  RISK FACTORS

 

Please refer to Part I, Item 1A, “Risk Factors,” in our annual report on Form 10-K for the year ended December 31, 2014 “our “2014 Annual Report”,2015, for information regarding factors that could affect our results of operations, financial condition and liquidity. There have been no material changes to the information set forth in Part I. Item 1A. “Risk Factors” in our 2014 Annual Report, except for the risk factors set forth below:

 

Although we will be requiredOur board of directors has asked our stockholders to raise additional funds during the fourth quarter of 2015, there is no assurance that such funds can be raised on terms that we would find acceptable, onapprove a timely basis, or at all.

Additional debt or equity financing will be required for usproposal to continue as a going concern. We may seek to obtain additional funds for the financing ofauthorize our cervical cancer detection business through additional debt or equity financings and/or new collaborative arrangements. Management believes that additional financing, if obtainable, will be sufficient to support planned operations only for a limited period. Management has implemented operating actions to reduce cash requirements. Any required additional funding may not be available on terms attractive to us, on a timely basis, or at all.

Certain provisions of our certificate of incorporation that authorize the issuance of additional shares of preferred stock may make it more difficult for a third partyboard to effect a reverse stock split of our common stock. There are risks associated with a reverse stock split, if it is effected.

On May 18, 2016, our board determined to recommend that at our 2016 annual stockholders’ meeting, our stockholders grant the board the authority, in its discretion, to effect a reverse stock split by a ratio of not less than 1:10 and not more than 1:400, with no change in control.

Our certificatethe number of incorporation authorizes our board of directors to issue up to 5 millionauthorized shares of preferred stock. Our undesignated shares of preferred stock may be issued in one or more series, the terms of which may be determined by the board without further stockholder action. These terms may include, among other terms, voting rights, including the right to vote as a series on particular matters, preferences as to liquidation and dividends, repurchase rights, conversion rights, redemption rights and sinking fund provisions. The issuance of any preferred stock could diminish the rights of holders of our common stock, and therefore could reduceall fractional shares created by the valuereverse stock split to be rounded to the nearest whole share. On May 26, 2016, our largest stockholder, John Imhoff, who is also one of our directors, agreed to vote his shares of common stock in favor of the reverse stock split. As of the record date for the 2016 annual meeting, Dr. Imhoff held 10,361,179 shares, or 19.26%, of the outstanding shares of common stock. In addition, specific rights grantedOn August [*], 2016, in response to future holders of preferred stock could be used to restrict our ability to merge with or sell assets to a third party. The ability of our board to issue preferred stock could make it more difficult, delay, discourage, prevent or make it more costly to acquire or effect a changesustained drops in control, which in turn could prevent our stockholders from recognizing a gain in the event that a favorable offer is extended and could materially and negatively affect the market price of our common stock, the board determined to increase the ratio for the reverse stock split to 1:800.

We intend to effect the reverse stock split as soon as practicable after stockholder approval; however, there are no assurances that the reverse stock split will be implemented. If the reverse stock split is effected, there are certain risks associated with the reverse stock split, including the following:

·We would have additional authorized shares of common stock that the board could issue in future without stockholder approval, and such additional shares could be issued, among other purposes, in financing transactions or to resist or frustrate a third-party transaction that is favored by a majority of the independent stockholders. This could have an anti-takeover effect, in that additional shares could be issued, within the limits imposed by applicable law, in one or more transactions that could make a change in control or takeover of us more difficult.
·There can be no assurance that the reverse stock split, if completed, will achieve the benefits that we hope it will achieve. The total market capitalization of our common stock after the reverse stock split may be lower than the total market capitalization before the reverse stock split.

The reverse stock split may decrease the liquidity of the shares of our common stock.

The liquidity of the shares of our common stock may be affected adversely by the reverse stock split given the reduced number of shares that will be outstanding following the reverse stock split, especially if the market price of our common stock does not increase as a result of the reverse stock split. In addition, the reverse stock split may increase the number of stockholders who own odd lots of our common stock, creating the potential for such stockholders to experience an increase in the cost of selling their shares and greater difficulty effecting such sales.

Following the reverse stock split, the resulting market price of our common stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our common stock may not improve.

Although we believe that a higher market price of our common stock may help generate greater or broader investor interest, there can be no assurance that the reverse stock split will result in a share price that will attract new investors, including institutional investors. In addition, there can be no assurance that the market price of our common stock will satisfy the investing requirements of those investors. As a result, the trading liquidity of our common stock may not necessarily improve.

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ITEM 2.  UNREGISTERRED SALES OF EQUITY PROCEEDSSECURITIES AND USE OF PROCEEDS.

 

None

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

Not applicable.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5. OTHER INFORMATION

 

Not applicable.

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ITEM 6.  EXHIBITS

EXHIBIT INDEX

EXHIBITS

 

Exhibit NumberExhibit Description
  
3.1Restated Certificate of Incorporation, as amended through November 13, 2015May 3, 2016 (incorporated by reference to Exhibit 3.1 to the quarterly report on Form 10-Q for the quarter ended March 31, 2016, filed May 19, 2016)
4.1Form of Warrant (Series B-Tranche B Exchanges; GPB Exchange) (incorporated by reference to Exhibit 4.1 to the current report on Form 8-K filed June 14, 2016)
10.1Rollover and Amendment Agreement, dated April 27, 2016, by and between the Company and Aquarius Opportunity Fund (incorporated by reference to Exhibit 10.2 to the current report on Form 8-K filed May 3, 2016)
10.2Form of Letter Agreement (Series C Exchanges) (incorporated by reference to Exhibit 10.1 to the current report on Form 8-K filed May 3, 2016)
10.3License Agreement, dated June 5, 2016 (incorporated by reference to Exhibit 10.1 to the current report on Form 8-K filed June 8, 2016)
10.4Form of Warrant Exchange  Agreement (Warrant-for-Shares) (incorporated by reference to Exhibit 10.1 to the current report on Form 8-K filed June 14, 2016)
10.5Form of Warrant Exchange Agreement (Warrant-for-Warrant) (incorporated by reference to Exhibit 10.2 to the current report on Form 8-K filed June 14, 2016)
31Rule 13a-14(a)/15d-14(a) Certification
32Section 1350 Certification
101XBRL

 

 

 

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SIGNATURES

 

In accordance with the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

GUIDED THERAPEUTICS, INC.
 
/s/ Gene S. Cartwright

 

By:

 

Gene S. Cartwright

 President, Chief Executive Officer and
 Acting Chief Financial Officer

 

Date:

 

November 12, 2015August 17, 2016

 

   

 

 

 

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