0001493152-14-002406.txt : 20140811 0001493152-14-002406.hdr.sgml : 20140811 20140808083313 ACCESSION NUMBER: 0001493152-14-002406 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 9 CONFORMED PERIOD OF REPORT: 20140630 FILED AS OF DATE: 20140808 DATE AS OF CHANGE: 20140808 FILER: COMPANY DATA: COMPANY CONFORMED NAME: LIXTE BIOTECHNOLOGY HOLDINGS, INC. CENTRAL INDEX KEY: 0001335105 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 202903526 STATE OF INCORPORATION: DE FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-51476 FILM NUMBER: 141025671 BUSINESS ADDRESS: STREET 1: 248 ROUTE 25A STREET 2: NO. 2 CITY: EAST SETAUKET STATE: NY ZIP: 11733 BUSINESS PHONE: 310 203 2902 MAIL ADDRESS: STREET 1: 248 ROUTE 25A STREET 2: NO. 2 CITY: EAST SETAUKET STATE: NY ZIP: 11733 FORMER COMPANY: FORMER CONFORMED NAME: SRKP 7 INC DATE OF NAME CHANGE: 20050803 10-Q 1 form10q.htm QUARTERLY REPORT FORM 10-Q

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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

 

For the quarterly period ended June 30, 2014

 

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

 

Commission file number: 000-51476

 

LIXTE BIOTECHNOLOGY HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   20-2903526
(State or other jurisdiction of   (I.R.S. Employer
incorporation or organization)   Identification Number)

 

248 Route 25A, No. 2

East Setauket, New York 11733

(Address of principal executive offices)

 

(631) 942-7959

(Registrant’s telephone number, including area code)

 

Not applicable

(Former name, former address and former fiscal year, if changed since last report)

 

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 [X] No [  ]

 

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, or a non-accelerated filer (as defined in Rule 12b-2 of the Exchange Act).

 

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 July 31, 2014, the Company had 45,483,097 shares of common stock, $0.0001 par value, issued and outstanding.

 

Documents incorporated by reference: None

  

 

 

 
 

 

LIXTE BIOTECHNOLOGY HOLDINGS, INC.
AND SUBSIDIARY

TABLE OF CONTENTS

 

   Page
Number
    
PART I - FINANCIAL INFORMATION   
    
Item 1. Condensed Consolidated Financial Statements  F-1
    
Condensed Consolidated Balance Sheets - June 30, 2014 (Unaudited) and December 31, 2013  F-1
    
Condensed Consolidated Statements of Operations (Unaudited) - Three Months and Six Months Ended June 30, 2014 and 2013  F-2
    
Condensed Consolidated Statement of Stockholders’ Equity (Deficiency) (Unaudited) - Six Months Ended June 30, 2014  F-3
    
Condensed Consolidated Statements of Cash Flows (Unaudited) - Six Months Ended June 30, 2014 and 2013  F-4
    
Notes to Condensed Consolidated Financial Statements (Unaudited) - Three Months and Six Months Ended June 30, 2014 and 2013  F-5
    
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations  4
    
Item 3. Quantitative and Qualitative Disclosures about Market Risk  14
    
Item 4. Controls and Procedures  14
    
PART II - OTHER INFORMATION 
    
Item 1. Legal Proceedings  15
    
Item 1A. Risk Factors  15
    
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds  15
    
Item 3. Defaults Upon Senior Securities  15
    
Item 4. Mine Safety Disclosures  15
    
Item 5. Other Information  15
    
Item 6. Exhibits  15
    
SIGNATURES  16

 

2
 

 

Forward-Looking Statements

 

This Quarterly Report on Form 10-Q contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. For example, statements regarding the Company’s financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about future product demand, supply, manufacturing, costs, marketing and pricing factors are all forward-looking statements. These statements are generally accompanied by words such as “intend,” “anticipate,” “believe,” “estimate,” “potential(ly),” “continue,” “forecast,” “predict,” “plan,” “may,” “will,” “could,” “would,” “should,” “expect” or the negative of such terms or other comparable terminology. The Company believes that the assumptions and expectations reflected in such forward-looking statements are reasonable, based on information available to it on the date hereof, but the Company cannot provide assurances that these assumptions and expectations will prove to have been correct or that the Company will take any action that the Company may presently be planning. However, these forward-looking statements are inherently subject to known and unknown risks and uncertainties. Actual results or experience may differ materially from those expected, anticipated or implied in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, regulatory policies, available cash, research and development results, competition from other similar businesses, and market and general economic factors. This discussion should be read in conjunction with the condensed consolidated financial statements and notes thereto included in Item 1 of this Quarterly Report on Form 10-Q and the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013, including the section entitled “Item 1A. Risk Factors.” The Company does not intend to update or revise any forward-looking statements to reflect new information, future events or otherwise.

 

3
 

 

PART I - FINANCIAL INFORMATION

 

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

LIXTE BIOTECHNOLOGY HOLDINGS, INC.
AND SUBSIDIARY

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

   June 30, 2014   December 31, 2013 
   (Unaudited)     
         
ASSETS          
Current assets:          
Cash  $46,719   $475,019 
Money market funds   1,193,663    6,135 
Advances on research and development contract services   34,986    33,880 
Prepaid expenses and other current assets   26,827    43,006 
Total current assets   1,302,195    558,040 
Total assets  $1,302,195   $558,040 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable and accrued expenses  $111,119   $107,774 
Research and development contract liabilities, including $36,540 and $34,398 to a related party at June 30, 2014 and December 31, 2013, respectively   49,329    47,283 
Liquidated damages payable under registration rights agreement   74,000    74,000 
Due to stockholder   92,717    92,717 
Total current liabilities   327,165    321,774 
           
Commitments and contingencies          
           
Stockholders’ equity:          
Preferred stock, $0.0001 par value; authorized – 10,000,000 shares; issued – none   —    — 
Common stock, $0.0001 par value; authorized – 100,000,000 shares; issued and outstanding – 45,483,097 shares and 41,583,097 shares at June 30, 2014 and December 31, 2013, respectively   4,548    4,158 
Additional paid-in capital   15,592,596    13,184,081 
Accumulated deficit   (14,622,114)   (12,951,973)
Total stockholders’ equity   975,030    236,266 
Total liabilities and stockholders’ equity  $1,302,195   $558,040 

 x

See accompanying notes to condensed consolidated financial statements.

 

F-1
 

 

LIXTE BIOTECHNOLOGY HOLDINGS, INC.
AND SUBSIDIARY

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

   Three Months Ended   Six Months Ended 
   June 30,   June 30, 
   2014   2013   2014   2013 
                 
Revenues  $—   $—   $—   $— 
                     
Costs and expenses:                    
General and administrative costs, including $62,809 and $38,912 to related parties for the three months ended June 30, 2014 and 2013, respectively, and $449,687 and $86,210 for the six months ended June 30, 2014 and 2013, respectively   181,557    120,013    734,566    287,655 
Research and development costs, including $101,008 and $78,979 to related parties for the three months ended June 30, 2014 and 2013, respectively, and $186,478 and $141,405 for the six months ended June 30, 2014 and 2013, respectively   335,723    248,795    498,493    415,099 
Total costs and expenses   517,280    368,808    1,233,059    702,754 
Loss from operations   (517,280)   (368,808)   (1,233,059)   (702,754)
Interest income   28    1    29    1 
Fair value of warrant extensions   (224,074)   —    (302,691)   — 
Fair value of warrant discount   —    —    (134,420)   — 
Net loss  $(741,326)  $(368,807)  $(1,670,141)  $(702,753)
                     
Net loss per common share – Basic and diluted  $(0.02)  $(0.01)  $(0.04)  $(0.02)
                     
Weighted average common shares outstanding – Basic and diluted   45,018,262    41,583,097    43,310,169    41,583,097 

  

See accompanying notes to condensed consolidated financial statements.

 

F-2
 

 

LIXTE BIOTECHNOLOGY HOLDINGS, INC.

AND SUBSIDIARY

 

CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY

(Unaudited)

 

Six Months Ended June 30, 2014

 

           Additional       Total 
   Common Stock   Paid-in   Accumulated   Stockholders’ 
   Shares   Amount   Capital   Deficit   Equity 
Balance, December 31, 2013   41,583,097   $4,158   $13,184,081   $(12,951,973)  $236,266 
Exercise of stock warrants   3,900,000    390    1,412,110    —    1,412,500 
Fair value of warrant extensions   —    —    302,691    —    302,691 
Fair value of warrant discount   —    —    134,420    —    134,420 
Stock-based compensation expense   —    —    559,294    —    559,294 
Net loss   —    —    —    (1,670,141)   (1,670,141)
Balance, June 30, 2014   45,483,097   $4,548   $15,592,596   $(14,622,114)  $975,030 

 

See accompanying notes to condensed consolidated financial statements.

 

F-3
 

 

LIXTE BIOTECHNOLOGY HOLDINGS, INC.
AND SUBSIDIARY

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

   Six Months Ended 
   June 30, 
   2014   2013 
         
Cash flows from operating activities:          
Net loss  $(1,670,141)  $(702,753)
Adjustments to reconcile net loss to net cash used in operating activities:          
Stock-based compensation expense included in general and administrative costs   437,185    89,567 
Stock-based compensation expense included in research and development costs   122,109    — 
Fair value of warrant extensions   302,691    — 
Fair value of warrant discount   134,420    — 
Changes in operating assets and liabilities:          
(Increase) decrease in -          
Advances on research and development contract services   (1,106)   9,265 
Prepaid expenses and other current assets   16,179    19,350 
Increase (decrease) in -          
Accounts payable and accrued expenses   3,345    (14,465)
Research and development contract liabilities   2,046    19,328 
Net cash used in operating activities   (653,272)   (579,708)
           
Cash flows from investing activities:          
Increase in money market funds   (1,187,528)   (1)
Net cash used in investing activities   (1,187,528)   (1)
           
Cash flows from financing activities:          
Proceeds from exercise of warrants   1,412,500    — 
Net cash provided by financing activities   1,412,500    — 
           
Cash:          
Net decrease   (428,300)   (579,709)
Balance at beginning of period   475,019    1,655,122 
Balance at end of period  $46,719   $1,075,413 
           
Supplemental disclosures of cash flow information:          
Cash paid for -          
Interest  $—   $— 
Income taxes  $—   $— 

 

See accompanying notes to condensed consolidated financial statements.

 

F-4
 

 

LIXTE BIOTECHNOLOGY HOLDINGS, INC.

AND SUBSIDIARY

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

Three Months and Six Months Ended June 30, 2014 and 2013

 

1. Basis of Presentation

 

The condensed consolidated financial statements of Lixte Biotechnology Holdings, Inc., a Delaware corporation, and its wholly-owned Delaware subsidiary, Lixte Biotechnology, Inc. (collectively, the “Company”), at June 30, 2014, and for the three months and six months ended June 30, 2014 and 2013, are unaudited. In the opinion of management of the Company, all adjustments (including normal recurring adjustments) have been made that are necessary to present fairly the financial position of the Company as of June 30, 2014, and the results of its operations for the three months and six months ended June 30, 2014 and 2013, and its cash flows for the six months ended June 30, 2014 and 2013. Operating results for the interim periods presented are not necessarily indicative of the results to be expected for a full fiscal year. The condensed balance sheet at December 31, 2013 has been derived from the Company’s audited financial statements at such date.

 

The statements and related notes have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to such rules and regulations. These financial statements should be read in conjunction with the financial statements and other information included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013, as filed with the SEC.

 

As the Company’s has not yet commenced any revenue-generating operations, does not have any cash flows from operations, and is dependent on debt and equity funding to finance its operations, the Company is considered a development stage company.

 

In June 2014, as discussed in Note, 2, the Financial Accounting Standards Board issued new guidance that removed all incremental financial reporting requirements from generally accepted accounting principles in the United States for development stage entities. The Company early adopted this new guidance effective June 30, 2014, as a result of which all inception-to-date financial information and disclosures have been omitted from this report.

 

2. Business Operations

 

Business

 

The Company is engaged in research and development activities with respect to anti-cancer treatments and other common non-malignant diseases. As the Company’s planned principal operations have not yet commenced, the Company activities are subject to significant risks and uncertainties, including the need to obtain additional financing, as described below.

 

The Company’s common stock is traded on the OTCQB operated by the OTC Markets under the symbol “LIXT”.

 

Operating Plans

 

The Company’s primary focus is developing new treatments for human cancers for which better therapies are urgently needed. The scope of potential applications of the Company’s products has expanded to other common non-malignant diseases, including vascular diseases (heart attacks and stroke, diabetes, and genetic diseases, such as Gaucher’s disease) in which errors in normal cellular processing lead to loss of functions important to normal cell function. This has occurred because the targets selected by the Company have multiple functions in the cell, which when altered result in different disorders that may benefit by treatment from the Company’s products.

 

The Company’s drug discovery process is based on discerning clues to potential new targets for disease treatments reported in the increasingly large body of literature identifying the molecular variants which characterize human cancers and other non-cancer disorders. The Company designs drugs for which there are existing data suggesting that they may affect the altered pathways of the cancer cell and may be given safely to humans. The Company seeks to rapidly arrive at patentable structures through analysis of the literature rather than screening of thousands of structures for activity against a particular biochemical pathway.

 

F-5
 

 

This approach has led to the development of two classes of drugs for the treatment of cancer: protein phosphatase inhibitors (PTase-i), designated by the Company as the LB-100 series of compounds, and histone deacetylase inhibitors (HDACi), designated by the Company as the LB-200 series of compounds. Compounds of both types also have potential use in the prevention and treatment of neurodegenerative diseases. The LB-100 series consists of novel structures, which have the potential to be first in their class, and may be useful in the treatment of not only several types of cancer but also vascular and metabolic diseases. The LB-200 series contains compounds which have the potential to be the most effective in its class and may be useful for the treatment of chronic hereditary diseases, such as Gaucher’s disease, in addition to cancer and neurodegenerative diseases.

 

 The Company has demonstrated that lead compounds of both series of drugs are active against a broad spectrum of human cancers in cell culture and against several types of human cancers in animal models. The research on new drug treatment was initiated in 2006 with the National Institute of Neurological Disorders and Stroke (“NINDS”) of the National Institutes of Health (“NIH”) under a Cooperative Research and Development Agreement (“CRADA”) effective March 22, 2006. The research at NINDS was led by Dr. Zhengping Zhuang, an internationally recognized investigator in the molecular pathology of cancer. The initial focus of the CRADA was on the most common and uniformly fatal brain tumor of adults, glioblastoma multiforme (“GBM”). The work at NIH was then extended to the most common brain tumor of children, medulloblastoma, and to the most common extracranial solid tumor of children, neuroblastoma. The CRADA was extended through a series of amendments and remained in effect until April 1, 2013, when it terminated as scheduled.

 

On August 16, 2011, the United States Patent and Trademark Office (the “PTO”) awarded a patent to the Company for its lead compound, LB-100, as well as for a number of structurally related compounds. On November 15, 2011, the PTO awarded a patent to the Company for a lead compound in the LB-200 series and a compound in the LB-100 series as neuroprotective agents for the prevention and treatment of neurodegenerative diseases. On March 27, 2012, the PTO awarded a patent to the Company for its lead compound LB-201, as well as for a number of structurally related compounds. Patent applications on these compounds and their use are pending world-wide.

 

The Company’s primary objective has been to bring one lead compound of the LB-100 series to clinical trial. In 2012, the Company completed the pre-clinical studies required to prepare an Investigation New Drug (“IND”) application to the FDA to conduct a Phase 1 clinical trial of LB-100, and engaged Theradex Systems, Inc. (“Theradex”), an international contract research organization (“CRO”) that provides professional services for the clinical research and development of pharmaceutical compounds, to be responsible for the clinical development of the Company’s lead compound, LB-100, and to prepare an IND application for filing with the FDA.

 

The Company filed an IND application with the FDA on April 30, 2012, and on July 24, 2012, the FDA notified the Company that it would allow initiation of a Phase 1 clinical trial of LB-100. The purpose of the clinical trial is to demonstrate that LB-100 can be administered safely to human beings at a dose and at a frequency that achieves the desired pharmacologic effect; in this case, inhibition of a specific enzyme, without being associated with toxicities considered unacceptable.

 

The Phase 1 clinical trial of LB-100 began in April 2013 with the entry of patients into the clinical trial (NCTO 1837667 at www.clinicaltrials.gov) and was initiated at the City of Hope National Medical Center in Duarte, California, and was extended in December 2013 to include the Mayo Clinic in Rochester, Minnesota, both of which are Comprehensive Cancer Centers designated by the National Cancer Institute. The Company estimates that the Phase 1 clinical trial will be completed between March and June 2015 and will cost a total of approximately $2,000,000, which will be paid to or through Theradex, the CRO responsible for the clinical development of LB-100. Total costs charged to operations through June 30, 2014 for services paid to Theradex pursuant to this arrangement total $452,381, of which $94,008 and $75,079 were incurred during the three months ended June 30, 2014 and 2013, respectively, and $173,660 and $123,862 were incurred during the six months ended June 30, 2014 and 2013, respectively. The Company is currently exploring, through Theradex, adding additional clinical sites to the ongoing Phase 1 clinical trial to maximize the efficiency of patient accrual. The final cost of the clinical trial is variable, depending upon the number of patients needed to be medically screened to determine if they meet the criteria for entry into the study and ultimately upon the total number of patients entered into the study to establish the proper doses of the drug for Phase 2 clinical trials.

 

After completion of the Phase 1 clinical trial of LB-100, the Company anticipates that the next step in the clinical development of LB-100 will be to determine its anti-cancer activity in combination with docetaxel, a standard anti-cancer drug currently on the market, against a specific type of human cancer in a Phase 2 clinical trial. Subject to the availability of funds, the Company intends to conduct a randomized clinical trial of docetaxel +/- LB-100 against a common cancer type for which single agent docetaxel is indicated, and to determine the appropriate dose of LB-100 in combination with a second cytotoxic drug for evaluation subsequently in a Phase 2 clinical trial.

 

F-6
 

 

As a compound moves through the FDA approval process, it becomes an increasingly valuable property, but at a cost of additional investment at each stage. The Company’s approach has been to operate with a minimum of overhead, moving compounds forward as efficiently and inexpensively as possible, and to raise funds to support each of these stages as certain milestones are reached. The commencement of a Phase 1 clinical trial is a milestone in the Company’s goal of developing a successful product platform.

 

Going Concern

 

The Company’s condensed consolidated financial statements have been presented on the basis that it is a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has not generated any revenues from operations to date, and does not expect to do so in the foreseeable future. The Company has experienced recurring operating losses and negative operating cash flows since inception, and has financed its working capital requirements during this period primarily through the recurring sale of its equity securities and the exercise of outstanding warrants. As a result, management believes that there is substantial doubt about the Company’s ability to continue as a going concern.

 

The Company’s ability to continue as a going concern is dependent upon its ability to raise additional capital and to ultimately achieve sustainable revenues and profitable operations. The Company’s condensed consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.

 

At June 30, 2014, the Company had not yet commenced any revenue-generating operations. All activity through June 30, 2014 has been related to the Company’s capital raising efforts and research and development activities. As such, the Company has yet to generate any cash flows from operations, and is dependent on debt and equity funding from both related and unrelated parties to finance its operations.

 

Because the Company is currently engaged in research at an early stage, it will likely take a significant amount of time to develop any product or intellectual property capable of generating revenues. As such, the Company’s business is unlikely to generate any sustainable revenues in the next several years, and may never do so. Even if the Company is able to generate revenues in the future through licensing its technologies or through product sales, there can be no assurance that the Company will be able to achieve positive earnings and cash flows from operations.

 

At June 30, 2014, the Company had cash and money market funds aggregating $1,240,382, the result primarily of $1,412,500 raised by the Company in April 2014 by offering a 50% discount to warrant holders as an inducement to exercise their warrants for cash. The amount and timing of future cash requirements will depend on the pace of the Company’s programs, in particular the completion of the Phase 1 clinical trial of LB-100. The Company believes that it has sufficient funds to continue with the Phase 1 clinical trial of LB-100 and to fund its operating plans through June 30, 2015. Accordingly, the Company will need to raise additional capital in 2015, likely in the form of equity. Market conditions present uncertainty as to the Company’s ability to secure additional funds. There can be no assurances that the Company will be able to secure additional financing on acceptable terms or at all. If cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its technology and product development programs and/or clinical trials, or obtain funds, if available (although there can be no certainty), through strategic alliances that may require the Company to relinquish rights to certain of its products, or to discontinue its operations entirely.

 

After completion of the Phase 1 clinical trial of LB-100, subject to the availability of funds, the Company anticipates that next step would be to determine the anti-cancer activity of LB-100, in combination with a widely used anti-cancer drug, against a specific type of human cancer in a Phase 2 clinical trial. In addition, subject to the availability of funds, the Company intends to continue the two drug development programs currently in process, and expand its patent portfolio, including the maintenance of its applications for international protection of lead compounds of both the LB-100 and LB-200 series.

 

3. Summary of Significant Accounting Policies

 

Principles of Consolidation

 

The accompanying condensed consolidated financial statements include the financial statements of Holdings and its wholly-owned subsidiary, Lixte. Intercompany balances and transactions have been eliminated in consolidation.

 

F-7
 

 

Cash Concentrations

 

The Company’s cash balances may periodically exceed federally insured limits. The Company has not experienced a loss in such accounts to date. The Company maintains its accounts with financial institutions with high credit ratings. 

 

Research and Development

 

Research and development costs consist primarily of fees paid to consultants and outside service providers, patent fees and costs, and other expenses relating to the acquisition, design, development and testing of the Company’s treatments and product candidates.

 

Research and development costs are expensed as incurred over the life of the underlying contracts on the straight-line basis, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. Payments made pursuant to research and development contracts are initially recorded as advances on research and development contract services in the Company’s balance sheet and then charged to research and development costs in the Company’s statement of operations as those contract services are performed. Expenses incurred under research and development contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s balance sheet, with a corresponding charge to research and development costs in the Company’s statement of operations. The Company reviews the status of its research and development contracts on a quarterly basis.

 

Patent Costs

 

Due to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s research efforts and any related patent applications, all patent costs, including patent-related legal and filing fees, are expensed as incurred. Patent costs were $88,055 and $102,916 for the three months ended June 30, 2014 and 2013, respectively, and $155,799 and $199,595 for the six months ended June 30, 2014 and 2013, respectively. Patent costs are included in research and development costs in the Company’s condensed consolidated statements of operations.

 

Royalties

 

Pursuant to a Patent License Agreement with the NIH that provides the Company with an exclusive license for all patents submitted jointly with the NIH under the CRADA, various categories of royalties at various rates and amounts are payable, including minimum annual royalties (subject to an offset for royalties from net sales), royalties on net sales, royalties based on the achievement of certain benchmarks, and royalties based on granting sublicense agreements, with respect to joint patents. Such royalties are accrued and paid when they become legal obligations, and are charged to general and administrative costs.

 

Concentration of Risk

 

The Company periodically contracts with directors, including companies controlled by or associated with directors, to provide consulting services related to the Company’s research and development and clinical trial activities. Agreements for these services can be for a specific time period (typically one year) or for a specific project or task, and can include both cash and non-cash compensation. The only such contract that represents 10% or more of general and administrative or research and development costs is described below. 

 

On September 21, 2012, the Company entered into a work order agreement with Theradex, the CRO responsible for the clinical development of the Company’s lead compound, LB-100, to manage and administer the Phase 1 clinical trial of LB-100. The Phase 1 clinical trial of LB-100, which began during April 2013 with the entry of patients into the clinical trial, is being carried out by nationally recognized comprehensive cancer centers, and is estimated to be completed between March and June 2015. The Phase 1 clinical trial is estimated to cost approximately $2,000,000, with such payments expected to be divided approximately evenly between payments to Theradex for services rendered and payments for pass-through costs for the clinical center’s laboratory costs and investigator costs. Total costs charged to operations through June 30, 2014 for services paid to Theradex pursuant to this arrangement, which were first incurred in 2013, total $452,381, of which $94,008 and $75,079 were incurred during the three months ended June 30, 2014 and 2013, respectively, or approximately 28% and 30% of research and development costs for the three months ended June 30, 2014 and 2013, respectively. During the six months ended June 30, 2014 and 2013, the Company incurred $173,660 and $123,862 were incurred during the six months ended June 30, 2014 and 2013, respectively, or approximately 35% and 30% of research and development costs for the six months ended June 30, 2014 and 2013, respectively. The costs charged to operations for amounts paid to Theradex for services relating to the Phase 1 clinical trial of LB-100 are expected to represent a larger percentage of total research and development costs during the fiscal years ending December 31, 2014 and 2015 as compared to prior fiscal years. Costs pursuant to this agreement are included in research and development costs in the Company’s condensed consolidated statements of operations.

 

F-8
 

 

In addition to the above described agreement with Theradex, the Company has also from time to time engaged Theradex to assist the Company in bringing LB-100 through the FDA approval process and to provide other regulatory services. Total fees charged to operations for services paid to Theradex pursuant to such engagements were $999 and $-0- for the three months ended June 30, 2014 and 2013, respectively, or approximately -0-% and -0-% of research and development costs for the three months ended June 30, 2014 and 2013, respectively and are included in research and development costs in the Company’s condensed consolidated statements of operations. During the six months ended June 30, 2014 and 2013, the Company incurred $6,818 and $7,393, respectively, or approximately 1% and 2% of research and development costs for the six months ended June 30, 2014 and 2013, respectively.

 

Income Taxes

 

The Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly, the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and the tax basis of assets and liabilities.

 

The Company has elected to deduct research and development costs on a current basis for federal income tax purposes. For federal tax purposes, start-up and organization costs were deferred until January 1, 2008 at which time the Company began to amortize such costs over a 180-month period.

 

The Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized. In the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of its recorded amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination was made. Likewise, should the Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred tax assets would be charged to operations in the period such determination was made.

 

For federal income tax purposes, net operating losses can be carried forward for a period of 20 years until they are either utilized or until they expire.

 

On January 1, 2007, the Company adopted accounting rules which address the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under these rules, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position are measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement. These accounting rules also provide guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. As of June 30, 2014, no liability for unrecognized tax benefits was required to be recorded.

 

The Company files income tax returns in the U.S. federal jurisdiction and is subject to income tax examinations by federal tax authorities for the year 2009 and thereafter. The Company’s policy is to record interest and penalties on uncertain tax provisions as income tax expense. As of June 30, 2014, the Company has no accrued interest or penalties related to uncertain tax positions.

 

Stock-Based Compensation

 

The Company periodically issues stock options and warrants to officers, directors and consultants for services rendered. Options vest and expire according to terms established at the grant date.

 

The Company accounts for stock-based payments to officers and directors by measuring the cost of services received in exchange for equity awards based on the grant date fair value of the awards, with the cost recognized as compensation expense in the Company’s financial statements on a straight-line basis over the vesting period of the awards.

 

The Company accounts for stock-based payments to consultants by determining the value of the stock compensation based upon the measurement date at either (a) the date at which a performance commitment is reached or (b) at the date at which the necessary performance to earn the equity instruments is complete.

 

F-9
 

 

Options granted to members of the Company’s Scientific Advisory Committee and to outside consultants are revalued each reporting period to determine the amount to be recorded as an expense in the respective period. As the options vest, they are valued on each vesting date and an adjustment is recorded for the difference between the value already recorded and the then current value on the date of vesting.

 

Earnings Per Share

 

The Company’s computation of earnings per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as the income (loss) available to common shareholders divided by the weighted average common shares outstanding for the period. Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., warrants and options) as if they had been converted at the beginning of the periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS.

 

Loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the respective periods. Basic and diluted loss per common share is the same for all periods presented because all warrants and stock options outstanding are anti-dilutive.

 

At June 30, 2014 and 2013, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive.

 

   2014   2013 
         
Warrants   2,928,800    6,828,800 
Stock options   7,500,000    3,650,000 
Total   10,428,800    10,478,800 

 

Fair Value of Financial Instruments

 

The authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels, and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair value measurements, is also required.

 

Level 1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities and exchange-based derivatives.

 

Level 2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities, non-exchange based derivatives, mutual funds, and fair-value hedges.

 

Level 3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently-traded non-exchange-based derivatives and commingled investment funds, and are measured using present value pricing models.

 

The Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Company performs an analysis of the assets and liabilities at each reporting period end.

 

Money market funds are the only financial instrument that is measured and recorded at fair value on the Company’s consolidated balance sheet on a recurring basis.

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

 

F-10
 

 

Recent Accounting Pronouncements

 

On June 10, 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update No. 2014-10 (ASU 2014-10), Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation. ASU 2014-10 eliminates the requirement to present inception-to-date information about income statement line items, cash flows, and equity transactions, and clarifies how entities should disclosure the risks and uncertainties related to their activities. ASU 2014-10 also eliminates an exception provided to development stage entities in Consolidations (ASC Topic 810) for determining whether an entity is a variable interest entity on the basis of the amount of investment equity that is at risk. The presentation and disclosure requirements in Topic 915 will no longer be required for interim and annual reporting periods beginning after December 15, 2014, and the revised consolidation standards will take effect in annual periods beginning after December 15, 2015. Early adoption is permitted. The Company adopted the provisions of ASU 2014-10 effective for its financial statements for the interim period ended June 30, 2014, and accordingly, is no longer presenting the inception-to-date financial information and disclosures formerly required.

 

On May 28, 2014, the FASB issued Accounting Standards Update No. 2014-09 (ASU 2014-09), Revenue from Contracts with Customers. ASU 2014-09 will eliminate transaction- and industry-specific revenue recognition guidance under current U.S. GAAP and replace it with a principle based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. ASU 2014-09 is effective for reporting periods beginning after December 15, 2016, and early adoption is not permitted. Entities can transition to the standard either retrospectively or as a cumulative-effect adjustment as of the date of adoption. As the Company does not expect to have any operating revenues for the foreseeable future, the Company does not expect the adoption of this guidance to have any impact on the Company’s consolidated financial statement presentation or disclosures.

 

In April 2014, the FASB issued Accounting Standards Update No. 2014-08 (ASU 2014-08), Presentation of Financial Statements (Topic 205) and Property, Plant and Equipment (Topic 360). ASU 2014-08 amends the requirements for reporting discontinued operations and requires additional disclosures about discontinued operations. Under the new guidance, only disposals representing a strategic shift in operations or that have a major effect on the Company’s operations and financial results should be presented as discontinued operations. This new accounting guidance is effective for annual periods beginning after December 15, 2014. As the Company is engaged in research and development activities and the Company’s planned principal operations have not yet commenced, the Company does not expect the adoption of this guidance to have any impact on the Company’s consolidated financial statement presentation or disclosures.

 

Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the Securities and Exchange Commission did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statement presentation or disclosures. 

 

4. Common Stock and Common Stock Warrants

 

On January 28, 2014, the Company’s Board of Directors extended to June 30, 2014 outstanding warrants to acquire 1,748,800 shares of the Company’s common stock exercisable at $0.50 per share that were issued to investors and the placement agent in connection with private placements that closed on February 10, 2009, March 2, 2009 and April 6, 2009. On September 30, 2012, the Company had previously extended all other outstanding warrants to June 30, 2014. Included in the January 2014 extension were warrants to acquire 815,920 shares of common stock scheduled to expire on February 10, 2014, warrants to acquire 312,880 shares of common stock scheduled to expire on March 2, 2014, and warrants to acquire 620,000 shares of common stock scheduled to expire on April 6, 2014. The difference in the fair value of the warrants immediately before and after the grant of the extensions, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $78,617 (average of $0.04 per share), and such amount was charged to operations on January 28, 2014. The fair value of the warrant extensions was calculated using the following input variables: stock price - $0.15 per share; exercise price - $0.50 per share; expected life – 13 to 153 days; expected volatility – 262%; expected dividend yield - 0%; risk-free interest rate – 1.51%.

 

F-11
 

 

On January 28, 2014, the Company offered to all of its warrant holders an inducement to exercise early by reducing the exercise price of currently outstanding warrants by 50%, if exercised on a cash basis by April 15, 2014. The exercise prices of the warrants before reduction were $0.50 per share (2,253,800 warrants) and $0.75 per share (4,575,000 warrants). The difference in the fair value of the warrants immediately before and after the grant of the discount, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $134,420 (an average of $0.02 per share), and such amount was charged to operations on January 28, 2014. The fair value of the warrant extensions was calculated using the following input variables: stock price - $0.15 per share; exercise price - $0.50 and $0.75 per share; expected life – 77 days (the period during which the discount was available); expected volatility – 262%; expected dividend yield - 0%; risk-free interest rate – 1.51%.

 

As a result of the discount warrant offer, warrants to acquire 3,900,000 shares of the Company’s common stock were exercised in April 2014 at discounts ranging from $0.25 to $0.375 per share. The exercise of the warrants generated aggregate net proceeds to the Company of $1,412,500.

 

On June 4, 2014, the Company’s Board of Directors extended to March 31, 2015 outstanding warrants to acquire 2,928,800 shares of the Company’s common stock that were issued to investors and the placement agent in connection with private placements that closed on February 10, 2009, March 2, 2009, April 6, 2009 and January 20, 2010, provided that the warrants were exercised in cash. Warrants to acquire 1,853,800 shares of the Company’s common stock were exercisable at $0.50 per share and 1,075,000 were exercisable at $0.75 per share. All warrants extended were scheduled to expire on June 30, 2014. The difference in the fair value of the warrants immediately before and after the grant of the extensions, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $224,074 (average of $0.08 per share), and such amount was charged to operations on June 4, 2014. The fair value of the warrant extensions was calculated using the following input variables: stock price - $0.22 per share; exercise price - $0.50 and $0.75 per share; expected life – 26 to 300 days; expected volatility – 173%; expected dividend yield - 0%; risk-free interest rate – 0.10%.

 

A summary of common stock warrant activity, including warrants to purchase common stock that were issued in conjunction with the Company’s private placements, is presented in the tables below. For presentation purposes, warrants that were extended are considered as outstanding for the entire period in which such extension occurs.

 

           Weighted 
           Average 
       Weighted   Remaining 
   Number   Average   Contractual 
   of   Exercise   Life 
   Shares   Price   (in Years) 
Warrants outstanding at December 31, 2012   6,828,800   $0.667      
Issued    —    —      
Exercised    —    —      
Expired    —    —      
Warrants outstanding at December 31, 2013   6,828,800    0.667      
Issued    —    —      
Exercised    (3,900,000)   0.263      
Expired    —    —      
Warrants outstanding at June 30, 2014    2,928,800   $0.592    0.75 
                
Warrants exercisable at December 31, 2013   6,659,840   $0.672      
Warrants exercisable at June 30, 2014   2,807,840   $0.596    0.75 

 

The exercise prices of common stock warrants outstanding and exercisable are as follows at June 30, 2014:

 

    Warrants   Warrants 
Exercise   Outstanding   Exercisable 
Prices   (Shares)   (Shares) 
          
$0.500    1,853,800    1,732,840 
$0.750    1,075,000    1,075,000 
      2,928,800    2,807,840 

 

F-12
 

 

Based on a fair market value of $0.15 per share on June 30, 2014, there were no exercisable but unexercised in-the-money common stock warrants on that date. Accordingly, there was no intrinsic value attributed to exercisable but unexercised common stock warrants at June 30, 2014.

 

Based on a fair market value of $0.13 per share on December 31, 2013, there were no exercisable but unexercised in-the-money common stock warrants on that date. Accordingly, there was no intrinsic value attributed to exercisable but unexercised common stock warrants at December 31, 2013

 

At June 30, 2014, warrants exercisable do not include warrants to acquire 120,960 shares of common stock that are contingent upon the exercise of warrants contained in units sold as part of the third private placement, as described above.

 

5. Money Market Funds

 

Money market funds at June 30, 2014 and December 31, 2013 consisted of investments in shares of Morgan Stanley New York Municipal Money Market Trust with a market value of $1,193,663 and $6,135, respectively.

 

The Morgan Stanley New York Municipal Money Market Trust is an open-end fund incorporated in the USA. The Fund’s objective is as high level of daily income exempt from federal and New York income tax as is consistent with stability of principal and liquidity. The Fund invests in high quality, short- term municipal obligations that pay interest exempt from federal and NY taxes.

 

The following table presents money market funds at their level within the fair value hierarchy at June 30, 2014 and December 31, 2013.

 

   Total   Level 1   Level 2   Level 3 
                 
June 30, 2014:                
Money market funds  $1,193,663   $1,193,663   $—   $— 
                     
December 31, 2013:                    
Money market funds  $6,135   $6,135   $—   $— 

 

6. Related Party Transactions

 

Advances from the Company’s founding stockholder and Chief Executive Officer, Dr. John Kovach, are non-interest bearing and are due on demand. At June 30, 2014 and December 31, 2013, such stockholder advances outstanding and due to Dr. Kovach totaled $92,717.

 

Dr. Kovach was paid a salary of $15,000 for the three months ended June 30, 2014 and 2013, and $30,000 for the six months ended June 30, 2014 and 2013, which amounts are included in general and administrative costs in the Company’s condensed consolidated statements of operations.

 

Dr. Kovach is not involved in other business activities but could, in the future, become involved in other business opportunities that become available. Accordingly, Dr. Kovach may face a conflict in selecting between the Company and his other business interests. The Company has not yet formulated a policy for the resolution of such potential conflicts.

 

The Company’s principal office facilities have been provided without charge by Dr. Kovach. Such costs were not material to the financial statements and, accordingly, have not been reflected therein.

 

On June 18, 2014, the Company entered into a sub-lease agreement for shared office space in New York City with the Eric Forman Law Office, a party providing legal and consulting services to the Company. The sub-lease is for a term of six months at a base rate of $875 per month. Eric Forman is the son-in-law of Gil Schwartzberg, a significant stockholder of and consultant to the Company. Legal and consulting fees charged to operations for services rendered by Eric Forman for the three months and six months ended June 30, 2014 were $10,000 and $22,000, respectively. The Company recognized similar charges aggregating $12,000 for the year ended December 31, 2013, all of which were recorded in the quarter ended December 31, 2013.

 

On May 21, 2012, the Company entered into an agreement with Dr. Mel Sorensen, a former member of the Company’s Board of Directors, for consultation and advice regarding the preparation and strategy for obtaining FDA allowance of a clinical trial of the lead compound of the LB-100 series. The term of the agreement was for the period from May 21, 2012 to May 31, 2013 and provided for a fee of $25,000, payable in two installments of $12,500 on May 21, 2012 and December 1, 2012. Consulting and advisory fees charged to operations pursuant to this agreement was $4,167 and $10,417 for the three months and six months ended June 30, 2013, respectively, and are included in research and development costs in the Company’s condensed consolidated statements of operations. Effective April 16, 2014, Dr. Sorenson resigned from the Company’s Board of Directors for personal reasons.

 

F-13
 

 

Periodically, the Company has entered into agreements with Ascentage Pharma Group to conduct various studies. As of June 30, 2014, contracts with a total estimated cost of $64,935, of which $38,881 had been paid, were in process. Ascentage Pharma Group is an offshoot of Ascenta Therapeutics, of which Dr. Sorensen is the President and Chief Executive Officer and a director. Ascentage Pharma Group and Ascenta Therapeutics have a continuing business relationship and certain common shareholders. However, Dr. Sorensen does not have any direct business relationship with or ownership in Ascentage Pharma Group.

 

On September 21, 2012, the Company entered into a work order agreement with Theradex, the CRO responsible for the clinical development of the Company’s lead compound, LB-100, to manage and administer the Phase 1 clinical trial of LB-100. The Phase 1 clinical trial of LB-100, which began during April 2013 with the entry of patients into the clinical trial, is being carried out by nationally recognized comprehensive cancer centers, and is estimated to be completed between March and June 2015. The Phase 1 clinical trial is estimated to cost approximately $2,000,000, with such payments expected to be divided approximately evenly between payments to Theradex for services rendered and payments for pass-through costs for the clinical center’s laboratory costs and investigator costs. Total costs charged to operations through June 30, 2014 for services paid to Theradex pursuant to this arrangement, which were first incurred in 2013, total $452,381, of which $94,008 and $75,079 were incurred during the three months ended June 30, 2014 and 2013, respectively, and $173,660 and $123,862 were incurred during the six months ended June 30, 2014 and 2013, respectively,. Costs pursuant to this agreement are included in research and development costs in the Company’s condensed consolidated statements of operations. On May 2, 2011, Dr. Robert B. Royds, the founder, Chairman of the Board and Medical Director of Theradex, was appointed to the Company’s Board of Directors. Dr. Royds died on March 23, 2013. The death of Dr. Royds is not expected to have any impact on the management and administration of the Phase 1 clinical trial of LB-100.

 

In addition to the above described agreement with Theradex, the Company has also from time to time engaged Theradex to assist the Company in bringing LB-100 through the FDA approval process and to provide other regulatory services. Total fees charged to operations for services paid to Theradex pursuant to such engagements were $999 and $-0- for the three months ended June 30, 2014 and 2013, respectively, respectively and are included in research and development costs in the Company’s condensed consolidated statements of operations. During the six months ended June 30, 2014 and 2013, the Company incurred $6,818 and $7,393, respectively, or approximately 1% and 2% of research and development costs for the six months ended June 30, 2014 and 2013, respectively.

 

Effective January 1, 2014, the Company entered into an Advisory Agreement with Dr. Kathleen P. Mullinix, a member of the Board of Directors of the Company, effective for an initial term of one year through December 31, 2014 to advise on business development matters. The initial term and any subsequent one year term shall be automatically extended on an annual basis unless a notice of intent to terminate is given by either party at least 90 days before the end of the applicable term. The Advisory Agreements provides for compensation of $25,000 annually, payable in two installments of $12,500, with the first payment due on January 31, 2014 and the second payment due on July 1, 2014. Total fees charged to operations for services paid to pursuant to this agreement were $6,250 and $12,500 for the three months and six months ended June 30, 2014, respectively, and are included in general and administrative costs in the Company’s condensed consolidated statements of operations.

 

Stock-based compensation arrangements involving members of the Company’s Board of Directors are described at Note 7. Total stock-based compensation expense relating to directors, officers and other related parties was $56,559 and $38,912 for the three months ended June 30, 2014 and 2013, respectively, and $437,187 and $86,210 for the six months ended June 30, 2014 and 2013, respectively.

 

7. Stock-Based Compensation

 

The Company grants stock options as incentive compensation to directors and as compensation for the services of independent contractors and consultants of the Company.

 

The fair value of each option awarded is estimated on the date of grant and subsequent measurement dates using the Black-Scholes option-pricing model. The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options. In addition, option valuation models require the input of highly subjective assumptions including the expected stock price volatility. Because the Company’s stock options have characteristics significantly different from those of traded options, and because changes in the subjective assumptions can materially affect the fair value estimate, in management’s opinion, the existing models do not necessarily provide a reliable single measure of the fair value of its stock options. The expected dividend yield assumption is based on the Company’s expectation of dividend payouts. Expected volatilities are based on historical volatility of the Company’s stock. The risk-free interest rate is based on the U.S. treasury yield curve in effect as of the grant date. Expected life of the options is the average of the vesting term and the full contractual term of the options.

 

F-14
 

 

New transactions during the six months ended June 30, 2014 that required an assessment of value pursuant to the Black-Scholes option-pricing model utilized the following inputs: exercise price per share - $0.25; stock price per share – $0.25; expected dividend yield – 0.00%; expected volatility – 173%; average risk-free interest rate – 1.67%; expected life – 5 years. For the purpose of assessing value for transactions requiring re-evaluation at June 30, 2014, the Black-Scholes option-pricing model utilized the following inputs: exercise price per share - $0.13 to $0.50; stock price per share – $0.15; expected dividend yield – 0.00%; expected volatility – 173%; average risk-free interest rate – 1.67%; expected life – 4.5 years.

 

There were no new transactions during the six months ended June 30, 2013 that required an assessment of value pursuant to the Black-Scholes option-pricing model. For the purpose of assessing value for transactions requiring re-evaluation at June 30, 2013 that were entered into in prior periods, the Black-Scholes option-pricing model utilized the following inputs: exercise price per share - $0.98; stock price per share – $0.25; expected dividend yield – 0.00%; expected volatility – 167%; average risk-free interest rate – 0.30%; expected life – 3.0 years.

 

On June 30, 2011, the Company granted to Dr. Philip F. Palmedo, a director of the Company, stock options to purchase 200,000 shares of common stock, exercisable for a period of five years from the date of grant at $0.98 per share, which was the fair market value of the Company’s common stock on such date. The options vest ratably in equal quarterly installments of 25,000 shares beginning July 1, 2011. The fair value of these options, as calculated pursuant to the Black-Scholes option-pricing model, was initially determined to be $196,000 ($0.98 per share). During the three months ended June 30, 2014 and 2013, the Company recorded charges to operations of $-0- and $24,399, respectively, with respect to these options. During the six months ended June 30, 2014 and 2013, the Company recorded charges to operations of $-0- and $48,530, respectively, with respect to these options.

 

On June 30, 2011, the Company granted to Dr. Iwao Ojima stock options to purchase 50,000 shares of common stock, exercisable for a period of five years from the date of grant at $0.98 per share, which was the fair market value of the Company’s common stock on such date. The options vest ratably in equal quarterly installments of 6,250 shares beginning July 1, 2011. The fair value of these options, as calculated pursuant to the Black-Scholes option-pricing model, was initially determined to be $49,000 ($0.98 per share). During the three months ended June 30, 2014 and 2013, the Company charged (credited) operations of $-0- and ($2,382), respectively, with respect to these options. During the six months ended June 30, 2014 and 2013, the Company recorded charges to operations of $-0- and $3,357, respectively, with respect to these options.

 

On January 28, 2014, the Company approved a second amendment to the Company’s consulting agreement with Gil Schwartzberg dated September 12, 2007 to extend it an additional four years to January 28, 2019 and granted to Mr. Schwartzberg stock options to purchase an additional aggregate of 4,000,000 shares of common stock, exercisable for a period of the earlier of five years from the grant date or the termination of the consulting agreement at $0.50 per share, with one-half of the options (2,000,000 shares) vesting immediately and one-half of the options (2,000,000 shares) vesting on January 28, 2015. The fair value of these options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $596,400 ($0.15 per share) on January 28, 2014, of which $298,200 is attributed to the options fully-vested on January 28, 2014 and as such was charged to operations on that date. The remaining unvested portion of the fair value of the options will be charged to operations ratably from January 28, 2014 through January 28, 2015. During the three months and six months ended June 30, 2014, the Company recorded charges to operations of $44,279 and $112,088 with respect to the remaining unvested portion of the options.

 

Effective May 1, 2011, in connection with his election to the Company’s Board of Directors, Dr. Robert B. Royds was granted stock options to purchase 200,000 shares of the Company’s common stock, vesting 25,000 shares on May 1, 2011, and 25,000 shares quarterly thereafter until all of the shares are vested, exercisable for a period of five years from each tranche’s vesting date, at $0.98 per share, which was the fair market value of the Company’s common stock on such date. The fair value of these options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $196,000 ($0.98 per share), and was charged to operations ratably from May 2, 2011 through February 1, 2013. During the three months and six months ended June 30, 2013, the Company recorded charges to operations of $0 and $8,548, respectively, with respect to these options. Dr. Royds died on March 23, 2013. The stock options expired unexercised.

 

F-15
 

 

Effective September 16, 2012, in connection with her election to the Company’s Board of Directors, Dr. Kathleen P. Mullinix was granted stock options to purchase 200,000 shares of the Company’s common stock, vesting 25,000 shares on September 16, 2012, and 25,000 shares quarterly thereafter until all of the shares are vested, exercisable for a period of five years from the date of grant at $0.65 per share, which was the fair market value of the Company’s common stock on such date. The fair value of these options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $118,000 ($0.59 per share), and is being charged to operations from September 16, 2012 through June 16, 2014. During the three months ended June 30, 2014 and 2013, the Company recorded charges to operations of $12,280 and $14,513, respectively, with respect to these options. During the six months ended June 30, 2014 and 2013, the Company recorded charges to operations of $26,899 and $29,132, respectively, with respect to these options.

 

On December 24, 2013, the Company entered into an agreement with NDA Consulting Corp. (“NDA”) for consultation and advice in the field of oncology research and drug development. As part of the agreement, NDA agreed to cause its president, Dr. Daniel D. Von Hoff, M.D., to become a member of the Company’s Scientific Advisory Committee. In connection with this agreement, NDA was granted stock options to purchase 100,000 shares of the Company’s common stock, vesting 25,000 shares on June 24, 2014, and thereafter 25,000 shares annually on June 24, 2015, 2016 and 2017, exercisable for a period of five years from the date of grant at $0.13 per share, which was the fair market value of the Company’s common stock on the grant date. The fair value of these options, as calculated pursuant to the Black-Scholes option-pricing model, was initially determined to be $12,960 ($0.13 per share), and is being charged to operations from December 24, 2013 through June 24, 2017. During the three months and six months ended June 30, 2014, the Company recorded charges to operations of $921 and $3,459, respectively, with respect to these options.

 

On June 26, 2014, the Company granted to Francis Johnson, a consultant to the Company and a co-owner of Chem-Master International, Inc., a vendor of the Company, immediately vesting stock options to purchase 500,000 shares of common stock, exercisable for a period of five years from the grant date at $0.25 per share. The fair value of these options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $118,650 ($0.24 per share), which was charged to operations on that date. The options were granted to Mr. Johnson as compensation for his contributions to the Company’s compound development activities.

 

A summary of stock option activity is presented in the tables below.

 

           Weighted 
           Average 
       Weighted   Remaining 
   Number   Average   Contractual 
   of    Exercise   Life 
   Shares   Price   (in Years) 
Options outstanding at December 31, 2012   3,750,000   $0.870      
Granted    100,000    0.130      
Exercised    —    —      
Expired    (700,000)   1.045      
Options outstanding at December 31, 2013   3,150,000    0.818      
Granted    4,500,000    0.472      
Exercised    —    —      
Expired    (150,000)   0.327      
Options outstanding at June 30, 2014    7,500,000   $0.619    3.68 
                
Options exercisable at December 31, 2013   3,000,000   $0.843      
Options exercisable at June 30, 2014   5,425,000   $0.670    2.85 

 

Total deferred compensation expense for the outstanding value of unvested stock options was approximately $166,000 at June 30, 2014, which is being recognized subsequent to June 30, 2014 over a weighted-average period of approximately six months.

 

The exercise prices of common stock options outstanding and exercisable are as follows at June 30, 2014: 

 

    Options   Options 
Exercise   Outstanding   Exercisable 
Prices   (Shares)   (Shares) 
          
$0.130    100,000    25,000 
$0.250    500,000    500,000 
$0.333    100,000    100,000 
$0.500    4,150,000    2,150,000 
$0.650    700,000    700,000 
$0.980    450,000    450,000 
$1.000    1,500,000    1,500,000 
      7,500,000    5,425,000 

 

F-16
 

 

Based on a fair market value of $0.15 per share on June 30, 2014, there were no exercisable but unexercised in-the-money common stock options on that date. Accordingly, there was no intrinsic value attributed to exercisable but unexercised common stock warrants at June 30, 2014.

 

Based on a fair market value of $0.13 per share on December 31, 2013, there were no exercisable but unexercised in-the-money stock options on that date. Accordingly, there was no intrinsic value attributed to exercisable but unexercised stock options at December 31, 2013. 

 

Outstanding options to acquire 2,075,000 shares of the Company’s common stock had not vested at June 30, 2014.

 

The Company expects to satisfy such stock obligations through the issuance of authorized but unissued shares of common stock.

 

8. Commitments and Contingencies

 

Effective September 19, 2008, the Company entered into a Patent License Agreement (the “PLA”) with the NIH providing the Company with an exclusive license for all patents submitted jointly with the NIH under the CRADA. The PLA provided for an initial payment of $25,000 to the NIH within 60 days of September 19, 2008, and for a minimum annual royalty of $30,000 on January 1 of each calendar year following the year in which the CRADA is terminated. The PLA also provided for the Company to pay (i) specified royalties based on net sales by the Company and its sub-licensees, reduced by the amount of the minimum annual royalty for that year, (ii) certain benchmark royalties upon the achievement of certain clinical benchmarks, and (iii) sublicensing royalties for the granting of sublicenses, with respect to joint patents. The Company paid the initial $25,000 obligation on November 10, 2008, which was charged to general and administrative costs. Due to the termination of the CRADA on April 1, 2013, the Company became obligated for a minimum annual royalty of $30,000 to the NIH beginning in 2014 and each year thereafter. As of January 31, 2014, a minimum royalty of $30,000 was due pursuant to the PLA, which was charged to general and administrative costs on that date and is included in accounts payable and accrued expenses in the accompanying condensed consolidated balance sheet at June 30, 2014. During April 2014, the Company advised the NIH of its intent to terminate this license.

 

Effective October 18, 2013, the Company entered into a Materials Cooperative Research and Development Agreement (M-CRADA) with the National Institute of Neurological Disorders and Stroke of the National Institutes of Health (NINDS, NIH) for a term of four years. The Surgical Neurology Branch of NINDS, NIH will conduct research characterizing a variety of compounds proprietary to the Company, and will examine the compounds’ potential for anti-cancer activity, reducing neurological deficit due to ischemia and brain injury, and stabilizing catalytic function of misfolded proteins for inborn brain diseases. Under an M-CRADA, a party provides research material, in this case proprietary compounds from the Company’s pipeline, for study by scientists at NIH. The exchange of material is for research only and implies no endorsement of the material on the part of either party. Under the M-CRADA the NIH grants a collaborator an exclusive option to elect an exclusive or non-exclusive commercialization license. The M-CRADA does not generate any incremental cost to the Company.

 

On September 21, 2012, the Company entered into a work order agreement with Theradex, the CRO responsible for the clinical development of the Company’s lead compound, LB-100, to manage and administer the Phase 1 clinical trial of LB-100. The Phase 1 clinical trial of LB-100, which began during April 2013 with the entry of patients into the clinical trial, is being carried out by nationally recognized comprehensive cancer centers, and is estimated to be completed between March and June 2015. The Phase 1 clinical trial is estimated to cost approximately $2,000,000, with such payments expected to be divided approximately evenly between payments to Theradex for services rendered and payments for pass-through costs for the clinical center’s laboratory costs and investigator costs. Total costs charged to operations through June 30, 2014 for services paid to Theradex pursuant to this arrangement, which were first incurred in 2013, total $452,381, of which $94,008 and $75,079 were incurred during the three months ended June 30, 2014 and 2013, respectively, and $173,660 and $123,862 were incurred during the six months ended June 30, 2014 and 2013, respectively. Costs pursuant to this agreement are included in research and development costs in the Company’s condensed consolidated statements of operations.

 

F-17
 

 

On December 24, 2013, the Company entered into an agreement with NDA Consulting Corp. (“NDA”) for consultation and advice in the field of oncology research and drug development. As part of the agreement, NDA agreed to cause its president, Dr. Daniel D. Von Hoff, M.D., to become a member of the Company’s Scientific Advisory Committee. The term of the agreement is for one year and provides for a quarterly cash fee of $4,000. Consulting and advisory fees charged to operations pursuant to this agreement were $4,000 and $8,000 during the three months and six months ended June 30, 2014.

 

On March 1, 2014, the Company entered into an agreement with Pro-Active Capital Resources LLC for various strategic, investor and public relations services. The agreement is for a term of six months, which may be cancelled by either party upon a thirty day notice, and requires a payment of $1,500 per month.

 

The following table sets forth the Company’s principal cash obligations and commitments for the next five fiscal years as of June 30, 2014 aggregating $2,205,003, of which $232,090 is included in current liabilities in the condensed consolidated balance sheet at June 30, 2014. Amounts included in the 2014 column represent amounts due at June 30, 2014 for the remainder of the 2014 fiscal year ending December 31, 2014.

 

       Payments Due By Year
   Total   2014   2015   2016   2017   2018 
Research and development contracts  $43,054   $43,054   $—   $—   $—   $— 
Theradex work order agreement   1,568,945    1,168,945    400,000    —    —    — 
Patent license agreement   150,000    30,000    30,000    30,000    30,000    30,000 
Operating leases   5,250    5,250    —    —    —    — 
Consulting agreements   12,500    12,500    —    —    —    — 
Liquidated damages payable under registration rights agreement   74,000    74,000    —    —    —    — 
Due to stockholder   92,717    92,717    —    —    —    — 
Total  $1,946,466   $1,426,466   $430,000   $30,000   $30,000   $30,000 

 

9. Subsequent Events

 

On July 15, 2014, Gil Schwartzberg, a significant stockholder of and consultant to the Company, assigned fully-vested stock options to acquire 1,000,000 shares of the Company’s common stock to Daniel Von Hoff, a member of the Company’s Scientific Advisory Committee. The options assigned included options to acquire 500,000 shares that had been previously granted to Mr. Schwartzberg on October 15, 2009, are exercisable at $1.00 per share, and expire on October 15, 2014, and options for 500,000 shares that had been previously granted to Mr. Schwartzberg on October 5, 2011, are exercisable at $1.00 per share, and expire on October 5, 2016. As Mr. Schwartzberg is considered an affiliate of the Company for accounting and securities purposes, the fair value of the stock options assigned by Mr. Schwartzberg to Mr. Von Hoff for the benefit of the Company will be recorded as a contribution to capital and a charge to operations. The fair value of the options assigned, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $43,500 (average of $0.04 per share), and such amount will be charged to operations on July 15, 2014. The fair value of the options assigned was calculated using the following input variables: stock price - $0.15 per share; exercise price - $1.00 per share; expected life – 92 and 812 days; expected volatility – 173%; expected dividend yield - 0%; risk-free interest rate – 0.03% and 0.49%.

 

F-18
 

 

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

 

Overview

 

Lixte Biotechnology Holdings, Inc., a Delaware corporation, including its wholly-owned Delaware subsidiary, Lixte Biotechnology, Inc. (collectively, the “Company”) is engaged in research and development activities with respect to anti-cancer treatments and other common non-malignant diseases. The Company has not yet commenced any revenue-generating operations, does not have any cash flows from operations, and is dependent on debt and equity funding to finance its operations.

 

The Company’s common stock is traded on the OTCQB operated by the OTC Markets under the symbol “LIXT”.

 

Going Concern

 

The Company’s condensed consolidated financial statements have been presented on the basis that it is a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has not generated any revenues from operations to date, and does not expect to do so in the foreseeable future. The Company has experienced recurring operating losses and negative operating cash flows since inception, and has financed its working capital requirements during this period primarily through the recurring sale of its equity securities and the exercise of outstanding warrants. As a result, management believes that there is substantial doubt about the Company’s ability to continue as a going concern.

 

The Company’s ability to continue as a going concern is dependent upon its ability to raise additional capital and to ultimately achieve sustainable revenues and profitable operations. The Company’s condensed consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.

 

At June 30, 2014, the Company had not yet commenced any revenue-generating operations. All activity through June 30, 2014 has been related to the Company’s capital raising efforts and research and development activities. As such, the Company has yet to generate any cash flows from operations, and is dependent on debt and equity funding from both related and unrelated parties to finance its operations.

 

Because the Company is currently engaged in research at an early stage, it will likely take a significant amount of time to develop any product or intellectual property capable of generating revenues. As such, the Company’s business is unlikely to generate any sustainable revenues in the next several years, and may never do so. Even if the Company is able to generate revenues in the future through licensing its technologies or through product sales, there can be no assurance that the Company will be able to achieve positive earnings and cash flows from operations.

 

At June 30, 2014, the Company had cash and money market funds aggregating $1,240,382, the result primarily of $1,412,500 raised by the Company in April 2014 by offering a 50% discount to warrant holders as an inducement to exercise their warrants for cash. The amount and timing of future cash requirements will depend on the pace of the Company’s programs, in particular the completion of the Phase 1 clinical trial of LB-100. The Company believes that it has sufficient funds to continue with the Phase 1 clinical trial of LB-100 and to fund its operating plans through June 30, 2015. Accordingly, the Company will need to raise additional capital in 2015, likely in the form of equity. Market conditions present uncertainty as to the Company’s ability to secure additional funds. There can be no assurances that the Company will be able to secure additional financing on acceptable terms or at all. If cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its technology and product development programs and/or clinical trials, or obtain funds, if available (although there can be no certainty), through strategic alliances that may require the Company to relinquish rights to certain of its products, or to discontinue its operations entirely.

 

After completion of the Phase 1 clinical trial of LB-100, subject to the availability of funds, the Company anticipates that next step would be to determine the anti-cancer activity of LB-100, in combination with a widely used anti-cancer drug, against a specific type of human cancer in a Phase 2 clinical trial. In addition, subject to the availability of funds, the Company intends to continue the two drug development programs currently in process, and expand its patent portfolio, including the maintenance of its applications for international protection of lead compounds of both the LB-100 and LB-200 series.

 

4
 

 

Recent Accounting Pronouncements

 

On June 10, 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update No. 2014-10 (ASU 2014-10), Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation. ASU 2014-10 eliminates the requirement to present inception-to-date information about income statement line items, cash flows, and equity transactions, and clarifies how entities should disclosure the risks and uncertainties related to their activities. ASU 2014-10 also eliminates an exception provided to development stage entities in Consolidations (ASC Topic 810) for determining whether an entity is a variable interest entity on the basis of the amount of investment equity that is at risk. The presentation and disclosure requirements in Topic 915 will no longer be required for interim and annual reporting periods beginning after December 15, 2014, and the revised consolidation standards will take effect in annual periods beginning after December 15, 2015. Early adoption is permitted. The Company adopted the provisions of ASU 2014-10 effective for its financial statements for the interim period ended June 30, 2014, and accordingly, is no longer presenting the inception-to-date financial information and disclosures formerly required.

 

On May 28, 2014, the FASB issued Accounting Standards Update No. 2014-09 (ASU 2014-09), Revenue from Contracts with Customers. ASU 2014-09 will eliminate transaction- and industry-specific revenue recognition guidance under current U.S. GAAP and replace it with a principle based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. ASU 2014-09 is effective for reporting periods beginning after December 15, 2016, and early adoption is not permitted. Entities can transition to the standard either retrospectively or as a cumulative-effect adjustment as of the date of adoption. As the Company does not expect to have any operating revenues for the foreseeable future, the Company does not expect the adoption of this guidance to have any impact on the Company’s consolidated financial statement presentation or disclosures.

 

In April 2014, the FASB issued Accounting Standards Update No. 2014-08 (ASU 2014-08), Presentation of Financial Statements (Topic 205) and Property, Plant and Equipment (Topic 360). ASU 2014-08 amends the requirements for reporting discontinued operations and requires additional disclosures about discontinued operations. Under the new guidance, only disposals representing a strategic shift in operations or that have a major effect on the Company’s operations and financial results should be presented as discontinued operations. This new accounting guidance is effective for annual periods beginning after December 15, 2014. As the Company is engaged in research and development activities and the Company’s planned principal operations have not yet commenced, the Company does not expect the adoption of this guidance to have any impact on the Company’s consolidated financial statement presentation or disclosures.

 

Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the Securities and Exchange Commission did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statement presentation or disclosures.

 

Concentration of Risk

 

The Company periodically contracts with directors, including companies controlled by or associated with directors, to provide consulting services related to the Company’s research and development and clinical trial activities. Agreements for these services can be for a specific time period (typically one year) or for a specific project or task, and can include both cash and non-cash compensation. The only such contract that represents 10% or more of general and administrative or research and development costs is described below.

 

On September 21, 2012, the Company entered into a work order agreement with Theradex, the CRO responsible for the clinical development of the Company’s lead compound, LB-100, to manage and administer the Phase 1 clinical trial of LB-100. The Phase 1 clinical trial of LB-100, which began during April 2013 with the entry of patients into the clinical trial, is being carried out by nationally recognized comprehensive cancer centers, and is estimated to be completed between March and June 2015. The Phase 1 clinical trial is estimated to cost approximately $2,000,000, with such payments expected to be divided approximately evenly between payments to Theradex for services rendered and payments for pass-through costs for the clinical center’s laboratory costs and investigator costs. Total costs charged to operations through June 30, 2014 for services paid to Theradex pursuant to this arrangement, which were first incurred in 2013, total $452,381, of which $94,008 and $75,079 were incurred during the three months ended June 30, 2014 and 2013, respectively, or approximately 28% and 30% of research and development costs for the three months ended June 30, 2014 and 2013, respectively. During the six months ended June 30, 2014 and 2013, the Company incurred $173,660 and $123,862 were incurred during the six months ended June 30, 2014 and 2013, respectively, or approximately 35% and 30% of research and development costs for the six months ended June 30, 2014 and 2013, respectively. The costs charged to operations for amounts paid to Theradex for services relating to the Phase 1 clinical trial of LB-100 are expected to represent a larger percentage of total research and development costs during the fiscal years ending December 31, 2014 and 2015 as compared to prior fiscal years. Costs pursuant to this agreement are included in research and development costs in the Company’s condensed consolidated statements of operations.

 

5
 

 

In addition to the above described agreement with Theradex, the Company has also from time to time engaged Theradex to assist the Company in bringing LB-100 through the FDA approval process and to provide other regulatory services. Total fees charged to operations for services paid to Theradex pursuant to such engagements were $999 and $-0- for the three months ended June 30, 2014 and 2013, respectively, or approximately -0-% and -0-% of research and development costs for the three months ended June 30, 2014 and 2013, respectively and are included in research and development costs in the Company’s condensed consolidated statements of operations. During the six months ended June 30, 2014 and 2013, the Company incurred $6,818 and $7,393, respectively, or approximately 1% and 2% of research and development costs for the six months ended June 30, 2014 and 2013, respectively.

 

Critical Accounting Policies and Estimates

 

The Company prepared its condensed consolidated financial statements in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. Management periodically evaluates the estimates and judgments made. Management bases its estimates and judgments on historical experience and on various factors that are believed to be reasonable under the circumstances. Actual results may differ from these estimates as a result of different assumptions or conditions.

 

The following critical accounting policies affect the more significant judgments and estimates used in the preparation of the Company’s consolidated financial statements.

 

Research and Development

 

Research and development costs consist primarily of fees paid to consultants and outside service providers, patent fees and costs, and other expenses relating to the acquisition, design, development and testing of the Company’s treatments and product candidates.

 

Research and development costs are expensed as incurred over the life of the underlying contracts on the straight-line basis, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. Payments made pursuant to research and development contracts are initially recorded as advances on research and development contract services in the Company’s balance sheet and then charged to research and development costs in the Company’s statement of operations as those contract services are performed. Expenses incurred under research and development contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s balance sheet, with a corresponding charge to research and development costs in the Company’s statement of operations. The Company reviews the status of its research and development contracts on a quarterly basis.

 

Patent Costs

 

Due to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s research efforts and any related patent applications, all patent costs, including patent-related legal and filing fees, are expensed as incurred.

 

Stock-Based Compensation

 

The Company periodically issues stock options and warrants to officers, directors and consultants for services rendered. Options vest and expire according to terms established at the grant date.

 

The Company accounts for stock-based payments to officers and directors by measuring the cost of services received in exchange for equity awards based on the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards.

 

6
 

 

The Company accounts for stock-based payments to consultants by determining the value of the stock compensation based upon the measurement date at either (a) the date at which a performance commitment is reached or (b) at the date at which the necessary performance to earn the equity instruments is complete.

 

Options granted to members of the Company’s Scientific Advisory Committee and to outside consultants are revalued each reporting period to determine the amount to be recorded as an expense in the respective period. As the options vest, they are valued on each vesting date and an adjustment is recorded for the difference between the value already recorded and the then current value on the date of vesting.

 

The fair value of stock-based compensation is affected by several variables, the most significant of which are the life of the equity award, the exercise price of the security as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common stock over the term of the equity award.

 

The Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development costs, as appropriate, in the condensed consolidated statement of operations.

 

Income Taxes

 

The Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly, the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and the tax basis of assets and liabilities.

 

The Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized. In the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of its recorded amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination was made. Likewise, should the Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred tax assets would be charged to operations in the period such determination was made.

 

Plan of Operation

 

General Overview of Plans

 

The Company’s original focus was the development of new treatments for the most common and most aggressive type of brain cancer of adults, glioblastoma multiforme (“GBM”), and the most common cancer of children, neuroblastoma. The Company has expanded the scope of its anti-cancer investigational activities to include the most common brain tumor of children, medulloblastoma, and also to several other types of more common cancers. This expansion of activity is based on documentation that each of two distinct types of drugs being developed by the Company has activity against cell lines of breast, colon, lung, prostate, pancreas, ovary, stomach and liver cancer, as well as against the major types of leukemias. LB-100 has now been shown to have activity in animal models of brain tumors of adults and children, and also against melanomas and sarcomas. Studies in animal models of human melanoma, lymphoma, sarcoma, brain tumors, and the rare neuroendocrine cancer, pheochromocytoma, have demonstrated marked potentiation by LB-100 of the anti-tumor activity of the widely used standard chemotherapeutic drugs. These studies confirm that the LB-100 compounds, combined with any of several standard anti-cancer drugs, have broad activity affecting many different cell types of cancer. This is unusual and important because these compounds may be useful for treatment of cancer in general.

 

The research on brain tumors was conducted in collaboration with the National Institute of Neurological Disorders and Stroke (“NINDS”) of the National Institutes of Health (“NIH”) under a Cooperative Research and Development Agreement (“CRADA”) entered into on March 22, 2006. The CRADA was extended through a series of amendments and remained in effect until April 1, 2013. The research at NINDS was led by Dr. Zhengping Zhuang, an internationally recognized investigator in the molecular pathology of cancer who was aided by two senior research technicians supported by the Company as part of the CRADA. The goal of the CRADA was to develop more effective drugs for the treatment of GBM through the processes required to gain allowance from the FDA for clinical trials. The CRADA terminated as scheduled on April 1, 2013.

 

During 2009, the Company signed material transfer agreements with academic investigators at major cancer centers in the United States, as well as with one investigator in China with a unique animal model of a sarcoma, to expand molecular and applied studies of the anti-cancer activity of the Company’s compounds. The Company retained the right to all discoveries made in these studies.

 

7
 

 

The Company’s immediate focus is to determine the safety and appropriate dose of LB-100 when used alone and when used in combination with a widely used anti-cancer drug in its Phase 1 clinical trial. The Company believes the potent activity of these drugs, in combination with standard non-specific chemotherapeutic drugs against a diverse array of common and uncommon cancers of adults and children, merits bringing this treatment to patients as rapidly as possible. If favorable treatment responses are also noted in the Phase 1 clinical trial, the Company would expect there to be increased interest by potential investors and by large pharmaceutical companies looking to add an entirely new approach to their anti-cancer drug portfolios. However, clinical benefit often is not apparent until a new compound advances to a Phase 2 clinical trial, which, if warranted, would be anticipated to follow the Phase 1 clinical trial.

 

The Company’s longer-term objective is to secure one or more strategic partnerships with pharmaceutical companies with major programs in cancer, anti-fungal treatments, and/or neuroprotective measures.

 

The significant diversity of the potential therapeutic value of the Company’s Series 2 compounds (LB-201 and homologs) stems from the fact that these agents modify critical pathways in cancer cells and in microorganisms such as fungi and appear to ameliorate pathologic processes that lead to brain injury caused by trauma or toxins or through as yet unknown mechanisms that underlie the major chronic neurologic diseases, including Alzheimer’s disease, Parkinson’s disease, and Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig’s disease).

 

Operating Plans

 

The Company’s primary focus is developing new treatments for human cancers for which better therapies are urgently needed. The scope of potential applications of the Company’s products has expanded to other common non-malignant diseases, including vascular diseases (heart attacks and stroke, diabetes, and genetic diseases, such as Gaucher’s disease) in which errors in normal cellular processing lead to loss of functions important to normal cell function. This has occurred because the targets selected by the Company have multiple functions in the cell, which when altered result in different disorders that may benefit by treatment from the Company’s products.

 

The Company’s drug discovery process is based on discerning clues to potential new targets for disease treatments reported in the increasingly large body of literature identifying the molecular variants, which characterize human cancers and other non-cancer disorders. In the past decade, there has been an unprecedented expansion in knowledge of biochemical defects in the cancer cell. The Company designs drugs for which there are existing data suggesting that they may affect the altered pathways of the cancer cell and may be given safely to humans. The Company seeks to rapidly arrive at patentable structures through analysis of the literature rather than screening of thousands of structures for activity against a particular biochemical pathway.

 

This approach has led to the development of two classes of drugs for the treatment of cancer: protein phosphatase inhibitors (PTase-i), designated by the Company as the LB-100 series of compounds, and histone deacetylase inhibitors (HDACi), designated by the Company as the LB-200 series of compounds. Compounds of both types also have potential use in the prevention and treatment of neurodegenerative diseases. The LB-100 series consists of novel structures, which have the potential to be first in their class, and may be useful in the treatment of not only several types of cancer but also vascular and metabolic diseases. The LB-200 series contains compounds which have the potential to be the most effective in its class and may be useful for the treatment of chronic hereditary diseases, such as Gaucher’s disease, in addition to cancer and neurodegenerative diseases. .

 

On August 16, 2011, the United States Patent and Trademark Office (the “PTO”) awarded a patent to the Company for its lead compound, LB-100, as well as for a number of structurally related compounds. On November 15, 2011, the PTO awarded a patent to the Company for a lead compound in the LB-200 series and a compound in the LB-100 series as neuroprotective agents for the prevention and treatment of neurodegenerative diseases. On March 27, 2012, the PTO awarded a patent to the Company for its lead compound, LB-201, as well as for a number of structurally related compounds. Patent applications on these compounds and their use are pending world-wide.

 

The Company has demonstrated that lead compounds of both series of drugs are active against a broad spectrum of human cancers in cell culture and against several types of human cancers in animal models. The research on new drug treatment was initiated in 2006 with the NINDS, NIH under a CRADA effective March 22, 2006. The initial focus of the CRADA was on GBM, the most common and uniformly fatal brain tumor of adults. The work at NIH was then extended to the most common brain tumor of children, medulloblastoma, and to the most common extracranial solid tumor of children, neuroblastoma. The CRADA was extended through a series of amendments and remained in effect until April 1, 2013, when it terminated as scheduled.

 

Effective treatment of brain tumors depends upon the ability of compounds to penetrate a physiological barrier known as the “blood-brain barrier”, which protects the brain from exposure to potentially toxic substances in the blood. Because there is no certainty that the Company’s compounds will be active against tumors confined to the brain, the LB-100 compounds have been studied against a variety of common and rare cancer types and have been shown to potentiate the activity of standard anti-cancer drugs in animal models of breast and pancreatic cancer, melanoma, pheochromcytomas and sarcomas. Because the LB-100 compounds appear to exert their ability to improve the effectiveness of different forms of chemotherapy and radiation therapy by inhibiting a process upon which most, if not all, cancer cell types depend on to survive treatment, the Company believes the LB-100 series of compounds may be useful against most, if not all, cancer types.

 

8
 

 

The second class of drugs under development by the Company, referred to as LB-200, is the histone deacetylase inhibitors. Many pharmaceutical companies are also developing drugs of this type, and at least two companies have HDACi approved for clinical use, in both cases for the treatment of a type of lymphoma. Despite this significant competition, the Company has demonstrated that its HDACi has broad activity against many cancer types, has neuroprotective activity, and has anti-fungal activity. In addition, these compounds have low toxicity, making them attractive candidates for development. It appears that one type of molecule has diverse effects, affecting biochemical processes that are fundamental to the life of the cell, whether they are cancer cells, nerve cells, or even fungal cells. The neuroprotective activity of the Company’s HDACi has been demonstrated in the test tube in model systems that mimic injury to brain cells, such as occurs in stroke and Alzheimer’s disease. This type of protective activity may have potential application to a broad spectrum of other chronic neurodegenerative diseases, including Parkinson’s disease and Amytrophic Lateral Sclerosis (ALS, or Lou Gehrig’s disease).

 

The Company’s primary objective has been to bring one lead compound of the LB-100 series to clinical trial. In 2012, the Company completed the pre-clinical studies needed to prepare an IND application to the FDA to conduct a Phase 1 clinical trial of LB-100, and engaged the CRO responsible for the clinical development of the Company’s lead compound, LB-100, to prepare an IND application for filing with the FDA. This task included preparing the detailed clinical protocol known as the “Investigator’s Brochure”, a document containing a detailed summary of all that is known about LB-100, and development of the formal IND application for submission to the FDA. The CRO also established the procedures for assuring appropriate collection and reporting of data generated during the clinical trial of LB-100 to the FDA.

 

The Company filed an IND application with the FDA on April 30, 2012, and on July 24, 2012, the FDA notified the Company that it would allow initiation of a Phase 1 clinical trial of LB-100. The purpose of the clinical trial is to demonstrate that LB-100 can be administered safely to human beings at a dose and at a frequency that achieves the desired pharmacologic effect; in this case, inhibition of a specific enzyme, without being associated with toxicities considered unacceptable. The Phase 1 clinical trial of LB-100 is designed to determine the maximum tolerable dose of LB-100 given alone and then in combination with a standard widely use anti-cancer drug. As a prelude to determining the therapeutic effectiveness of LB-100 in a subsequent Phase 2 clinical trial of common cancers, a key goal of the initial portion of the Phase 1 clinical trial will be to demonstrate that the target enzyme of LB-100, protein phosphatase 2A (PP2A), can be inhibited in humans with readily tolerable toxicity. As an anti-cancer drug, LB-100 is likely to be used at maximum tolerable doses, but for the potential treatment of non-malignant diseases, such as acute vascular diseases and metabolic diseases, lower doses may achieve therapeutic benefit by inhibition of the target enzyme, PP2A, thus opening up the possibility of a host of therapeutic applications for LB-100 and related proprietary compounds. The Company estimates that the Phase 1 clinical trial will be completed between March and June 2015 and will cost a total of approximately $2,000,000, which will be paid to or through Theradex, the CRO responsible for the clinical development of LB-100. Total costs charged to operations through June 30, 2014 for services paid to Theradex pursuant to this arrangement total $452,381, of which $94,008 and $75,079 were incurred during the three months ended June 30, 2014 and 2013, respectively, and $173,660 and $123,862 were incurred during the six months ended June 30, 2014 and 2013, respectively. The Company is currently exploring, through Theradex, adding additional clinical sites to the ongoing Phase 1 clinical trial to maximize the efficiency of patient accrual. The final cost of the clinical trial is variable, depending upon the number of patients needed to be medically screened to determine if they meet the criteria for entry into the study and ultimately upon the total number of patients entered into the study to establish the proper doses of the drug for Phase 2 clinical trials.

 

After completion of the Phase 1 clinical trial of LB-100, the Company anticipates that the next step in the clinical development of LB-100 will be to determine its anti-cancer activity in combination with docetaxel, a standard anti-cancer drug currently on the market, against a specific type of human cancer in a Phase 2 clinical trial. Subject to the availability of funds, the Company intends to conduct a randomized clinical trial of docetaxel +/- LB-100 against a common cancer type for which single agent docetaxel is indicated, and to determine the appropriate dose of LB-100 in combination with a second cytotoxic drug for evaluation subsequently in a Phase 2 clinical trial.

 

As a compound moves through the FDA approval process, it becomes an increasingly valuable property, but at a cost of additional investment at each stage. The Company’s approach has been to operate with a minimum of overhead, moving compounds forward as efficiently and inexpensively as possible, and to raise funds to support each of these stages as certain milestones are reached. The commencement of a Phase 1 clinical trial is a milestone in the Company’s goal of developing a successful product platform.

 

9
 

 

Results of Operations

 

The Company had not commenced revenue-generating operations at June 30, 2014.

 

Three Months Ended June 30, 2014 and 2013

 

General and Administrative. For the three months ended June 30, 2014, general and administrative costs were $181,557, which consisted of the fair value of stock options issued to directors and consultants of $56,559, consulting and professional fees of $80,662, insurance expense of $9,530, officer’s salary and related costs of $16,703, stock transfer fees of $3,987, travel and entertainment costs of $4,381, and other operating costs of $9,735.

 

For the three months ended June 30, 2013, general and administrative costs were $120,013, which consisted of the fair value of stock options issued to directors and consultants of $36,530, consulting and professional fees of $45,448, insurance expense of $9,290, officer’s salary and related costs of $16,673, stock transfer fees of $2,526, travel and entertainment costs of $5,717, and other operating costs of $3,829.

 

General and administrative costs increased by $61,544 or 51.3% in 2014 as compared to 2013, primarily as a result of an increase of $20,029 in stock-based compensation and an increase of $30,928 in legal and other consulting fees.

 

Research and Development. For the three months ended June 30, 2014, research and development costs were $335,723, which consisted of the vested portion of the fair value of stock options issued to a member of the Company’s Scientific Advisory Committee of $119,571, patent costs of $88,055, and contractor costs of $128,097, including $94,008 to a related party in connection with the Phase 1 clinical trial of LB-100.

 

For the three months ended June 30, 2013, research and development costs were $248,795, which consisted of patent costs of $102,916, contractor costs of $141,712, including $75,079 to a related party in connection with the Phase 1 clinical trial of LB-100, and consulting fees to a related party of $4,167.

 

Research and development costs increased by $86,928 or 34.9% in 2014 as compared to 2013, primarily as a result of an increase of $119,571 in stock-based compensation, offset by a decrease of $14,861 in patent costs.

 

Fair Value of Warrant Extensions. During the three months ended June 30, 2014, the Company incurred an expense of $224,074 for the fair value of extending the expiration date of warrants to acquire 2,928,800 shares of the Company’s common stock that were purchased by investors as part of private placements that closed in 2009 and 2010.

 

Net Loss. For the three months ended June 30, 2014, the Company incurred a net loss of $741,326, as compared to a net loss of $368,807 for the three months ended June 30, 2013.

 

Six Months Ended June 30, 2014 and 2013

 

General and Administrative. For the six months ended June 30, 2014, general and administrative costs were $734,566, which consisted of the fair value of stock options issued to directors and consultants of $437,187, consulting and professional fees of $183,927, royalties of $30,000, insurance expense of $19,068, officer’s salary and related costs of $33,771, stock transfer fees of $7,547, travel and entertainment costs of $7,589, and other operating costs of $15,477.

 

For the six months ended June 30, 2013, general and administrative costs were $287,655, which consisted of the fair value of stock options issued to directors and consultants of $89,567, consulting and professional fees of $125,816, insurance expense of $18,195, officer’s salary and related costs of $33,496, stock transfer fees of $4,521, travel and entertainment costs of $7,231, and other operating costs of $8,829.

 

General and administrative costs increased by $446,911 or 155.4% in 2014 as compared to 2013, primarily as a result of a increase of $347,620 in stock-based compensation and an increase of $58,111 in legal and other consulting fees.

 

A significant component of the fair value of stock options issued to directors and consultants of $437,187 for the six months ended June 30, 2014 was the $366,009 expense for the fair value of stock options to acquire 4,000,000 shares of the Company’s common stock that were issued to Gil Schwartzberg on January 28, 2014 for his continuing contributions to the Company’s financial strategy.

 

10
 

 

Research and Development. For the six months ended June 30, 2014, research and development costs were $498,493, which consisted of the vested portion of the fair value of stock options issued to a member of the Company’s Scientific Advisory Committee of $122,107, patent costs of $155,799, and contractor costs of $220,587, including $173,660 to a related party in connection with the Phase 1 clinical trial of LB-100.

 

For the six months ended June 30, 2013, research and development costs were $415,099, which consisted of patent costs of $199,595, contractor costs of $205,087, including $123,862 to a related party in connection with the Phase 1 clinical trial of LB-100, and consulting fees to a related party of $10,467.

 

Research and development costs increased by $83,394 or 20.0% in 2014 as compared to 2013, primarily as a result of an increase of $122,107 in stock-based compensation, offset by a decrease of $43,796 in patent costs.

 

Fair Value of Warrant Extensions. During the six months ended June 30, 2014, the Company incurred an expense of $302,691 for the fair value of extending the expiration dates of various warrants, including $78,617 for the extension of expiration dates of warrants to acquire 1,748,800 shares of the Company’s common stock to June 30, 2014, and $224,074 for the further extension of those expiration dates to March 31, 2015 for warrants to acquire 2,928,800 shares of the Company’s common stock that were purchased by investors as part of private placements that closed in 2009 and 2010, and were to have expired unexercised on June 30, 2014.

 

Fair Value of Warrant Discount. During the six months ended June 30, 2014, the Company incurred an expense of $134,420 for the fair value of discounts offered to warrant holders as an inducement for the early exercise of warrants to acquire 3,900,000 shares of the Company’s common stock. The discounts ranged from $0.25 to $0.375 per share. The exercise of the warrants generated net proceeds to the Company of $1,412,500 in April 2014.

 

Net Loss. For the six months ended June 30, 2014, the Company incurred a net loss of $1,670,141, as compared to a net loss of $702,753 for the six months ended June 30, 2013.

 

Liquidity and Capital Resources – June 30, 2014

 

The Company’s condensed consolidated financial statements have been presented on the basis that it is a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company is in the development stage and has not generated any revenues from operations to date, and does not expect to do so in the foreseeable future. The Company has experienced recurring operating losses and negative operating cash flows since inception, and has financed its working capital requirements through the recurring sale of its equity securities. As a result, management believes that there is substantial doubt about the Company’s ability to continue as a going concern (see “Going Concern” above”).

 

At June 30, 2014, the Company had working capital of $975,030, as compared to working capital of $236,266 at December 31, 2013, an increase in working capital of $738,764 for the six months ended June 30, 2014. At June 30, 2014, the Company had cash and money market funds aggregating $1,240,382, as compared to $481,154 at December 31, 2013, an increase of $759,228 for the six months ended June 30, 2014. The increase in working capital, cash and money market funds during the six months ended June 30, 2014 was the result of $1,412,500 raised by the Company in April 2014 by offering a 50% discount to warrant holders as an inducement to exercise their warrants for cash.

 

The Company filed an IND application with the FDA on April 30, 2012, and on July 24, 2012, the FDA notified the Company that it would allow initiation of a Phase 1 clinical trial of LB-100. The purpose of the clinical trial is to demonstrate that LB-100 can be administered safely to human beings at a dose and at a frequency that achieves the desired pharmacologic effect; in this case, inhibition of a specific enzyme, without being associated with toxicities considered unacceptable. The Phase 1 clinical trial of LB-100 began in April 2013 with the entry of patients into the clinical trial, and is being carried out by a nationally recognized comprehensive cancer center. The Company estimates that the Phase 1 clinical trial will be completed between March and June 2015 and will cost a total of approximately $2,000,000, which will be paid to or through Theradex, the CRO responsible for the clinical development of LB-100. Total costs charged to operations through June 30, 2014 for services paid to Theradex pursuant to this arrangement total $452,381, of which $94,008 and $75,079 were incurred during the three months ended June 30, 2014 and 2013, respectively, and $173,660 and $123,862 were incurred during the six months ended June 30, 2014 and 2013, respectively, which have been included in research and development expenses in the condensed consolidated statement of operations.

 

11
 

 

The Company believes that it has sufficient funds to continue with the Phase 1 clinical trial of LB-100 and to fund its operating plans through June 30, 2015. The amount and timing of future cash requirements will depend on the pace of the Company’s programs, in particular the completion of the Phase 1 clinical trial of LB-100. Accordingly, the Company will need to raise additional capital in 2015, likely in the form of equity. Market conditions present uncertainty as to the Company’s ability to secure additional funds. There can be no assurances that the Company will be able to secure additional financing on acceptable terms or at all. If cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its technology and product development programs and/or clinical trials, or obtain funds, if available (although there can be no certainty), through strategic alliances that may require the Company to relinquish rights to certain of its products, or to discontinue its operations entirely.

 

Operating Activities. For the six months ended June 30, 2014, operating activities utilized cash of $653,272, as compared to utilizing cash of $579,708 for the six months ended June 30, 2013, to support the Company’s ongoing research and development activities.

 

Investing Activities. For the six months ended June 30, 2014, investing activities consisted of an increase in money market funds of $1,187,528 due primarily as a result of proceeds received from the exercise of warrants in April 2014. For the six months ended June 30, 2013, investing activities consisted of a $1 increase in money market funds from interest earned during the period.

 

Financing Activities. For the six months ended June 30, 2014, financing activities consisted of $1,412,500 in proceeds received from the exercise of warrants for the purchase of 3,900,000 shares of the Company’s common stock in April 2014. There were no financing activities during the six months ended June 30, 2013.

 

Principal Commitments

 

Effective September 19, 2008, the Company entered into a Patent License Agreement (the “PLA”) with the NIH providing the Company with an exclusive license for all patents submitted jointly with the NIH under the CRADA. The PLA provided for an initial payment of $25,000 to the NIH within 60 days of September 19, 2008, and for a minimum annual royalty of $30,000 on January 1 of each calendar year following the year in which the CRADA is terminated. The PLA also provided for the Company to pay (i) specified royalties based on net sales by the Company and its sub-licensees, reduced by the amount of the minimum annual royalty for that year, (ii) certain benchmark royalties upon the achievement of certain clinical benchmarks, and (iii) sublicensing royalties for the granting of sublicenses, with respect to joint patents. The Company paid the initial $25,000 obligation on November 10, 2008, which was charged to general and administrative costs. Due to the termination of the CRADA on April 1, 2013, the Company became obligated for a minimum annual royalty of $30,000 to the NIH beginning in 2014 and each year thereafter. As of January 31, 2014, a minimum royalty of $30,000 was due pursuant to the PLA, which was charged to general and administrative costs on that date and is included in accounts payable and accrued expenses in the accompanying condensed consolidated balance sheet at June 30, 2014. During April 2014, the Company advised the NIH of its intent to terminate this license.

 

Effective October 18, 2013, the Company entered into a Materials Cooperative Research and Development Agreement (M-CRADA) with the National Institute of Neurological Disorders and Stroke of the National Institutes of Health (NINDS, NIH) for a term of four years. The Surgical Neurology Branch of NINDS, NIH will conduct research characterizing a variety of compounds proprietary to the Company, and will examine the compounds’ potential for anti-cancer activity, reducing neurological deficit due to ischemia and brain injury, and stabilizing catalytic function of misfolded proteins for inborn brain diseases. Under an M-CRADA, a party provides research material, in this case proprietary compounds from the Company’s pipeline, for study by scientists at NIH. The exchange of material is for research only and implies no endorsement of the material on the part of either party. Under the M-CRADA the NIH grants a collaborator an exclusive option to elect an exclusive or non-exclusive commercialization license. The M-CRADA does not generate any incremental cost to the Company.

 

On September 21, 2012, the Company entered into a work order agreement with Theradex, the CRO responsible for the clinical development of the Company’s lead compound, LB-100, to manage and administer the Phase 1 clinical trial of LB-100. The Phase 1 clinical trial of LB-100, which began during April 2013 with the entry of patients into the clinical trial, is being carried out by nationally recognized comprehensive cancer centers, and is estimated to be completed between March and June 2015. The Phase 1 clinical trial is estimated to cost approximately $2,000,000, with such payments expected to be divided approximately evenly between payments to Theradex for services rendered and payments for pass-through costs for the clinical center’s laboratory costs and investigator costs. Total costs charged to operations through June 30, 2014 for services paid to Theradex pursuant to this arrangement, which were first incurred in 2013, total $452,381, of which $94,008 and $75,079 were incurred during the three months ended June 30, 2014 and 2013, respectively, and $173,660 and $123,862 were incurred during the six months ended June 30, 2014 and 2013, respectively. Costs pursuant to this agreement are included in research and development costs in the Company’s condensed consolidated statements of operations. The Company is currently exploring, through Theradex, adding additional clinical sites to the ongoing Phase 1 clinical trial to maximize the efficiency of patient accrual. The final cost of the clinical trial is variable, depending upon the number of patients needed to be medically screened to determine if they meet the criteria for entry into the study and ultimately upon the total number of patients entered into the study to establish the proper doses of the drug for Phase 2 clinical trials.

 

12
 

 

On December 24, 2013, the Company entered into an agreement with NDA Consulting Corp. (“NDA”) for consultation and advice in the field of oncology research and drug development. As part of the agreement, NDA agreed to cause its president, Dr. Daniel D. Von Hoff, M.D., to become a member of the Company’s Scientific Advisory Committee. The term of the agreement is for one year and provides for a quarterly cash fee of $4,000. Consulting and advisory fees charged to operations pursuant to this agreement were $4,000 and $8,000 during the three months and six months ended June 30, 2014.

 

On March 1, 2014, the Company entered into an agreement with Pro-Active Capital Resources LLC for various strategic, investor and public relations services. The agreement is for a term of six months, which may be cancelled by either party upon a thirty day notice, and requires a payment of $1,500 per month.

 

The following table sets forth the Company’s principal cash obligations and commitments for the next five fiscal years as of June 30, 2014 aggregating $2,205,003, of which $232,090 is included in current liabilities in the condensed consolidated balance sheet at June 30, 2014. Amounts included in the 2014 column represent amounts due at June 30, 2014 for the remainder of the 2014 fiscal year ending December 31, 2014.

 

       Payments Due By Year 
   Total   2014   2015   2016   2017   2018 
Research and development contracts  $43,054   $43,054   $—   $—   $—   $— 
Theradex work order agreement   1,568,945    1,168,945    400,000    —    —    — 
Patent license agreement   150,000    30,000    30,000    30,000    30,000    30,000 
Operating leases   5,250    5,250    —    —    —    — 
Consulting agreements   12,500    12,500    —    —    —    — 
Liquidated damages payable under registration rights agreement   74,000    74,000    —    —    —    — 
Due to stockholder   92,717    92,717    —    —    —    — 
Total  $1,946,466   $1,426,466   $430,000   $30,000   $30,000   $30,000 

 

Off-Balance Sheet Arrangements

 

At June 30, 2014, the Company did not have any transactions, obligations or relationships that could be considered off-balance sheet arrangements.

 

13
 

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

 

Not applicable.

 

ITEM 4. CONTROLS AND PROCEDURES

 

(a) Evaluation of Disclosure Controls and Procedures

 

The Company carried out an evaluation, under the supervision and with the participation of its management, consisting of its principal executive officer and principal financial officer (who is the same person), of the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act (defined below)). Based upon that evaluation, the Company’s principal executive officer and principal financial officer concluded that, as of the end of the period covered in this report, the Company’s disclosure controls and procedures were effective to ensure that information required to be disclosed in reports filed under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported within the required time periods and is accumulated and communicated to the Company’s management, consisting of the Company’s principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure.

 

The Company’s management, consisting of its principal executive officer and principal financial officer, does not expect that its disclosure controls and procedures or its internal controls will prevent all error 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 are met. Furthermore, the design of a control system must reflect the fact that there are resource constraints and the benefits of controls must be considered relative to their costs. Due to the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. In addition, as conditions change over time, so too may the effectiveness of internal controls. However, management believes that the financial statements included in this report fairly present, in all material respects, the Company’s financial condition, results of operations and cash flows for the periods presented.

 

(b) Changes in Internal Controls Over Financial Reporting

 

The Company’s management, consisting of its principal executive officer and principal financial officer, has determined that no change in the Company’s internal control over financial reporting (as that term is defined in Rules 13(a)-15(f) and 15(d)-15(f) of the Securities Exchange Act of 1934) occurred during or subsequent to the end of the period covered in this report that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

14
 

 

PART II - OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

The Company is currently not a party to any pending or threatened legal proceedings.

 

ITEM 1A. RISK FACTORS

 

Not applicable.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

During April 2014, warrants to acquire 3,900,000 shares of the Company’s common stock were exercised at discounts ranging from $0.25 to $0.375 per share. The exercise of the warrants generated aggregate net proceeds to the Company of $1,412,500.

 

On June 26, 2014, the Company granted to Francis Johnson, a consultant to the Company and a co-owner of Chem-Master International, Inc., a vendor of the Company, immediately vesting stock options to purchase 500,000 shares of common stock, exercisable for a period of five years from the grant date at $0.25 per share. The options were granted to Mr. Johnson as compensation for his contributions to the Company’s compound development activities.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

Not applicable.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5. OTHER INFORMATION

 

Effective April 16, 2014, Dr. Mel Sorenson resigned from the Company’s Board of Directors for personal reasons.

 

ITEM 6. EXHIBITS

 

A list of exhibits required to be filed as part of this report is set forth in the Index to Exhibits, which is presented elsewhere in this document, and is incorporated herein by reference.

 

15
 

 

SIGNATURES

 

In accordance with the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  LIXTE BIOTECHNOLOGY HOLDINGS, INC.
  (Registrant)
     
Date: August 8, 2014 By: /s/ JOHN S. KOVACH
    John S. Kovach
    Chief Executive Officer and
    Chief Financial Officer
    (Principal financial and accounting officer)

 

16
 

 

INDEX TO EXHIBITS

 

The following documents are filed as part of this report:

 

Exhibit
Number		   Description of Document
     
31.1*   Officer’s Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
32.1*   Officer’s Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
101.INS**   XBRL Instance Document
     
101.SCH**   XBRL Taxonomy Extension Schema Document
     
101.CAL**   XBRL Taxonomy Extension Calculation Linkbase Document
     
101.LAB**   XBRL Taxonomy Extension Label Linkbase Document
     
101.PRE**   XBRL Taxonomy Extension Presentation Linkbase Document
     
101.DEF**   XBRL Taxonomy Extension Definition Linkbase Document

 

* Filed herewith.

** In accordance with Regulation S-T, the XBRL related information on Exhibit No. 101 to this Quarterly Report on Form 10-Q shall be deemed “furnished” herewith not “filed”. 

 

17
 

 

 

 EX-31.1 2 ex31-1.htm EXHIBIT 31.1 Exhibit 31.1

 

CERTIFICATIONS OF CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER
UNDER SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, John S. Kovach, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of Lixte Biotechnology Holdings, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)), for the registrant and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me by others within those entities, particularly during the period in which this report is being prepared;

 

  (b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s Board of Directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 8, 2014 By: /s/ JOHN S. KOVACH
    John S. Kovach
    Chief Executive Officer and Chief Financial Officer

 

 
 

 

 EX-32.1 3 ex32-1.htm EXHIBIT 32.1 Exhibit 32.1

 

CERTIFICATIONS OF CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER
UNDER SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

I, John S. Kovach, the Chief Executive Officer and Chief Financial Officer of Lixte Biotechnology Holdings, Inc. (the “Company”), certify, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350, that:

 

(i) The Quarterly Report on Form 10-Q of the Company for the quarterly period ended June 30, 2014 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and

 

(ii) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

 

Date: August 8, 2014 By: /s/ JOHN S. KOVACH
    John S. Kovach
    Chief Executive Officer and
    Chief Financial Officer

 

 
 

 

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Immediate Vesting [Member] The net change during the reporting period in advances on research and development services. The net change during the reporting period in the amount of research and development contract liabilities. Increase in cash and money market funds. Carrying value as of the balance sheet date of liability incurred for liquidated damages payable under registration rights agreement. Used to reflect the current portion of the liability that is due upon demand. Mirador Agreement [Member] The entire disclosure for the fair value of Investment in short-term money-market instruments (such as commercial paper, banker's acceptances, repurchase agreements, government securities, certificates of deposit, and so forth) which are highly liquid (that is, readily convertible to known amounts of cash) and so near their maturity that they present an insignificant risk of changes in value because of changes in interest rates. Mr Schwartzberg [Member]. Description and terms of national institute of health patent license agreement. Nda Consulting Corp Agreement [Member] New Transactions [Member]. Number of shares issued under discount warrant offer for acquire warrants. Number of warrants exercisable excluded warrants to acquire. Ojima [Member] Operating Leases. Option Expiration Date. Other unrelated vendor member. Outside director additional stock award plan member. Outside director stock award plan member. Patent costs. The Disclosure of accounting policies for costs incurred for the purpose of Patent rights. Amount of minimum annual royalty related to patent license agreement. Minimum royalty amount payable for patent license agreement. Payment For Cancellation Of Agreement. Payments due by 2014 [Member] Payments due by 2015 [Member] Payments due by 2016 [Member] Payments due by 2017 [Member] Payments due by 2018 [Member] Payments Due By Year Axis Payments Due By Year Domain The cash outflow associated with the purchase of money market funds during the period. The cash outflow for initial payments made to national institute of health patent license agreement. Percentage of additional clinical research and development costs. Percentage of clinical research and development costs. Percentage of reducing exercise price for currently outstanding warrants. Percentage of research and development costs. This element represents that, value of the sum of a firm's total principal cash obligations and commitments over the next five years. Carrying value of principal cash obligations and commitments included in current liabilities. Pro Active Agreement [Member] Quarterly Vesting Thereafter [Member] Represents the amount of research and development cost incurred in relation to related parties during the period. Sum of the carrying values as of the balance sheet date of obligations incurred through that date and due within one year (or the operating cycle, if longer), including liabilities incurred (and for which invoices have typically been received) and payable to vendors for contracted research and development activities. Research and development contract liabilities related parties. Amount of contractual obligation related to research and development contract commitments. The aggregate amount of noncash, equity-based remuneration to employees and vendors, included in total research and development expenses, related to research and development activities. This may include the value of stock or unit options, amortization of restricted stock or units, and adjustment for officers' compensation. As noncash, this element is an add back when calculating net cash generated by operating activities using the indirect method. The Disclosure of accounting policies for costs incurred for the purpose of royalties. Schedule Of Principal Cash Obligations and Commitments [Table text block] Tabular disclosure of warrants exercise prices, by grouped ranges and the number of shares warrants, weighted average exercise price and remaining contractual option terms. Scientific advisory committee members. Second Private Placement Issue [Member]. Share based compensation arrangement by share based payment award vesting date. Share based compensation arrangement by share based payment award non option equity exercisable. Share based compensation arrangement by share based payment award non option exercised in period weighted average exercise price. Share based compensation arrangement by share based payment award non option forfeited or expired in period weighted average exercise price. Share based compensation arrangement by share based payment award non option grand in period weighted average exercise price. Share based compensation arrangement by share based payment award non option outstanding weighted average number of share. Share based compensation arrangement by share based payment award non option weighted average exercisable. Number of share options (or share units) exercised during the period. Share issued during period for outstanding warrants acquire. Share-based compensation arrangement by share-based payment award equity instruments other than options exercisable but unexercised in-the-money common stock options. Weighted average remaining contractual term for vested portions of Non-options outstanding and currently exercisable or convertible, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Weighted average remaining contractual term for Non-option awards outstanding, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Stock Award Plan [Axis]. Stock awards agreement. Number of warrants exercised during the current period. Value stock issued during the period as a result of the exercise of stock Warrants. Per share amount of shares and warrants fair market value. Sublease Base Rate Per Month. Sublease Term. Third Private Placement Issue [Member]. Transactions [Axis]. Transactions Requiring Re Evaluation In Prior Periods [Member]. Vesting on January twenty eight two thousand fifteen [Member] Vesting on June twenty four twenty fifteen [Member] Vesting on June twenty four twenty seventeen [Member] Vesting on June twenty four twenty sixteen [Member] Warrant Seven [Member] Warrants acquisition expiration date. Number of warrants exercisable during the period. Warrants exercise prices. Warrants discount range Warrants extensions average price per share. Warrants Extensions One [Member]. Warrants Extensions Three [Member] Warrants Extensions Two [Member]. Warrants Five [Member] Warrants Four [Member]. Warrants One [Member]. Warrants Six [Member] Warrants Three [Member]. Warrants Two [Member]. This element represents that, value of commitment as of the balance sheet date of liability incurred for work order agreement. Theradex Systems, Inc. [Member] Fee payable for clinical trial. Assets, Current Assets Liabilities, Current Stockholders' Equity Attributable to Parent Liabilities and Equity Operating Expenses Operating Income (Loss) FairValueOfWarrantDiscount Shares, Outstanding IncreaseDecreaseInAdvancesOnResearchAndDevelopmentContractServices Increase (Decrease) in Prepaid Expense and Other Assets Increase (Decrease) in Accounts Payable and Accrued Liabilities Net Cash Provided by (Used in) Operating Activities PaymentsToAcquireMoneyMarketFunds Net Cash Provided by (Used in) Investing Activities Net Cash Provided by (Used in) Financing Activities Cash and Cash Equivalents, Period Increase (Decrease) Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block] Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Outstanding, Number ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionEquityExercisable ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionOutstandingWeightedAverageNumberOfShare ShareBasedCompensationArrangementByShareBasedPaymentAwardNonOptionWeightedAverageExercisable Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number ShareBasedCompensationShareBasedPaymentAwardOptionsExercised Share-based Compensation Arrangement by Share-based Payment Award, Options, Expirations in Period Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price Due to Officers or Stockholders PrincipalCashObligationsAndCommitments PaymentsDueByYearDomain EX-101.PRE 9 lixt-20140630_pre.xml XBRL PRESENTATION FILE EXCEL 10 Financial_Report.xlsx IDEA: XBRL DOCUMENT begin 644 Financial_Report.xlsx M4$L#!!0`!@`(````(0"I^C`/Y@$``,P7```3``@"6T-O;G1E;G1?5'EP97-= M+GAM;""B!`(HH``"```````````````````````````````````````````` M```````````````````````````````````````````````````````````` M```````````````````````````````````````````````````````````` M```````````````````````````````````````````````````````````` M```````````````````````````````````````````````````````````` M```````````````````````````````````````````````````````````` M```````````````````````````````````````````````````````````` M```````````````````````````````````````````````````````````` M```````````````````````````````````````````````````````````` M```````````````````````````````````````````````````````````` M```````````````````````````````````````````````````````````` M``````````````````````````````````````#,F-%JVS`8A>\+>P>CVQ$K MDM:N&W%ZL767;:'=`VC6G]C$EH2DMLG;5W;:4DJ6$A;8N8E)+/WGB\`?^,PN MUGU7/%"(K;,5$^64%61K9UJ[K-CONU^3^[MM8ID_(':]ZE3)X3RKQS7!.; 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Stock-Based Compensation - Summary of Stock Option Activity (Details) (USD $)
 6 Months Ended 12 Months Ended
Jun. 30, 2014
Dec. 31, 2013
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]    
Beginning Balance - Options outstanding - Number of Shares (in shares) 3,150,000 3,750,000
Granted - Number of Shares (in shares) 4,500,000 100,000
Exercised - Number of Shares (in shares)      
Expired - Number of Shares (in shares) (150,000) (700,000)
Ending Balance - Options outstanding - Number of Shares (in shares) 7,500,000 3,150,000
Options exercisable - Number of Shares (in shares) 5,425,000 3,000,000
Beginning Balance - Options outstanding - Weighted Average Exercise Price (in dollars per share) $ 0.818 $ 0.870
Granted - Weighted Average Exercise Price (in dollars per share) $ 0.472 $ 0.130
Exercised - Weighted Average Exercise Price (in dollars per share)      
Expired - Weighted Average Exercise Price (in dollars per share) $ 0.327 $ 1.045
Ending Balance - Options outstanding - Weighted Average Exercise Price (in dollars per share) $ 0.619 $ 0.818
Options exercisable - Weighted Average Exercise Price (in dollars per share) $ 0.670 $ 0.843
Options outstanding - Weighted Average Remaining Contractual Life (in Years) 3 years 8 months 5 days  
Options exercisable - Weighted Average Remaining Contractual Life (in Years) 2 years 10 months 6 days  

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Summary of Significant Accounting Policies - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details)
 6 Months Ended
Jun. 30, 2014
Jun. 30, 2013
Antidilutive securities excluded from computation of earnings per share, amount 10,428,800 10,478,800
Stock Options [Member]
    
Antidilutive securities excluded from computation of earnings per share, amount 7,500,000 3,650,000
Warrant [Member]
    
Antidilutive securities excluded from computation of earnings per share, amount 2,928,800 6,828,800
XML 14 R37.htm IDEA: XBRL DOCUMENT v2.4.0.8
Subsequent Events (Details Narrative) (USD $)
 0 Months Ended 6 Months Ended 0 Months Ended
Jun. 30, 2011
Jun. 30, 2014
Dec. 31, 2013
Oct. 05, 2011
Mr. Schwartzberg [Member]
Oct. 15, 2009
Mr. Schwartzberg [Member]
Jul. 15, 2014
Subsequent Event [Member]
Jul. 15, 2014
Subsequent Event [Member]
Minimum [Member]
Jul. 15, 2014
Subsequent Event [Member]
Maximum [Member]
Jul. 15, 2014
Subsequent Event [Member]
Stock Options [Member]
Jul. 15, 2014
Subsequent Event [Member]
Daniel Von Hoff [Member]
Options vest 25,000                 1,000,000
Options granted previously       500,000 500,000          
Options, exercisable price per share   $ 0.670 $ 0.843 $ 1.00 $ 1.00          
Option expiration date       Oct. 05, 2016 Oct. 15, 2014          
Options, fair value $ 196,000         $ 43,500        
Exercise price per share   $ 0.25       $ 0.04     $ 1.00  
Stock price per share   $ 0.25       $ 0.15        
Expected life   5 years         92 days 812 days    
Expected volatility   173.00%       173.00%        
Expected dividend yield   0.00%       0.00%        
Average risk-free interest rate   1.67%         0.03% 0.49%    
XML 15 R9.htm IDEA: XBRL DOCUMENT v2.4.0.8
Business Operations
 6 Months Ended
Jun. 30, 2014
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Business Operations

2. Business Operations

 

Business

 

The Company is engaged in research and development activities with respect to anti-cancer treatments and other common non-malignant diseases. As the Company’s planned principal operations have not yet commenced, the Company activities are subject to significant risks and uncertainties, including the need to obtain additional financing, as described below.

 

The Company’s common stock is traded on the OTCQB operated by the OTC Markets under the symbol “LIXT”.

 

Operating Plans

 

The Company’s primary focus is developing new treatments for human cancers for which better therapies are urgently needed. The scope of potential applications of the Company’s products has expanded to other common non-malignant diseases, including vascular diseases (heart attacks and stroke, diabetes, and genetic diseases, such as Gaucher’s disease) in which errors in normal cellular processing lead to loss of functions important to normal cell function. This has occurred because the targets selected by the Company have multiple functions in the cell, which when altered result in different disorders that may benefit by treatment from the Company’s products.

 

The Company’s drug discovery process is based on discerning clues to potential new targets for disease treatments reported in the increasingly large body of literature identifying the molecular variants which characterize human cancers and other non-cancer disorders. The Company designs drugs for which there are existing data suggesting that they may affect the altered pathways of the cancer cell and may be given safely to humans. The Company seeks to rapidly arrive at patentable structures through analysis of the literature rather than screening of thousands of structures for activity against a particular biochemical pathway.

 

This approach has led to the development of two classes of drugs for the treatment of cancer: protein phosphatase inhibitors (PTase-i), designated by the Company as the LB-100 series of compounds, and histone deacetylase inhibitors (HDACi), designated by the Company as the LB-200 series of compounds. Compounds of both types also have potential use in the prevention and treatment of neurodegenerative diseases. The LB-100 series consists of novel structures, which have the potential to be first in their class, and may be useful in the treatment of not only several types of cancer but also vascular and metabolic diseases. The LB-200 series contains compounds which have the potential to be the most effective in its class and may be useful for the treatment of chronic hereditary diseases, such as Gaucher’s disease, in addition to cancer and neurodegenerative diseases.

 

 The Company has demonstrated that lead compounds of both series of drugs are active against a broad spectrum of human cancers in cell culture and against several types of human cancers in animal models. The research on new drug treatment was initiated in 2006 with the National Institute of Neurological Disorders and Stroke (“NINDS”) of the National Institutes of Health (“NIH”) under a Cooperative Research and Development Agreement (“CRADA”) effective March 22, 2006. The research at NINDS was led by Dr. Zhengping Zhuang, an internationally recognized investigator in the molecular pathology of cancer. The initial focus of the CRADA was on the most common and uniformly fatal brain tumor of adults, glioblastoma multiforme (“GBM”). The work at NIH was then extended to the most common brain tumor of children, medulloblastoma, and to the most common extracranial solid tumor of children, neuroblastoma. The CRADA was extended through a series of amendments and remained in effect until April 1, 2013, when it terminated as scheduled.

 

On August 16, 2011, the United States Patent and Trademark Office (the “PTO”) awarded a patent to the Company for its lead compound, LB-100, as well as for a number of structurally related compounds. On November 15, 2011, the PTO awarded a patent to the Company for a lead compound in the LB-200 series and a compound in the LB-100 series as neuroprotective agents for the prevention and treatment of neurodegenerative diseases. On March 27, 2012, the PTO awarded a patent to the Company for its lead compound LB-201, as well as for a number of structurally related compounds. Patent applications on these compounds and their use are pending world-wide.

 

The Company’s primary objective has been to bring one lead compound of the LB-100 series to clinical trial. In 2012, the Company completed the pre-clinical studies required to prepare an Investigation New Drug (“IND”) application to the FDA to conduct a Phase 1 clinical trial of LB-100, and engaged Theradex Systems, Inc. (“Theradex”), an international contract research organization (“CRO”) that provides professional services for the clinical research and development of pharmaceutical compounds, to be responsible for the clinical development of the Company’s lead compound, LB-100, and to prepare an IND application for filing with the FDA.

 

The Company filed an IND application with the FDA on April 30, 2012, and on July 24, 2012, the FDA notified the Company that it would allow initiation of a Phase 1 clinical trial of LB-100. The purpose of the clinical trial is to demonstrate that LB-100 can be administered safely to human beings at a dose and at a frequency that achieves the desired pharmacologic effect; in this case, inhibition of a specific enzyme, without being associated with toxicities considered unacceptable.

 

The Phase 1 clinical trial of LB-100 began in April 2013 with the entry of patients into the clinical trial (NCTO 1837667 at www.clinicaltrials.gov) and was initiated at the City of Hope National Medical Center in Duarte, California, and was extended in December 2013 to include the Mayo Clinic in Rochester, Minnesota, both of which are Comprehensive Cancer Centers designated by the National Cancer Institute. The Company estimates that the Phase 1 clinical trial will be completed between March and June 2015 and will cost a total of approximately $2,000,000, which will be paid to or through Theradex, the CRO responsible for the clinical development of LB-100. Total costs charged to operations through June 30, 2014 for services paid to Theradex pursuant to this arrangement total $452,381, of which $94,008 and $75,079 were incurred during the three months ended June 30, 2014 and 2013, respectively, and $173,660 and $123,862 were incurred during the six months ended June 30, 2014 and 2013, respectively. The Company is currently exploring, through Theradex, adding additional clinical sites to the ongoing Phase 1 clinical trial to maximize the efficiency of patient accrual. The final cost of the clinical trial is variable, depending upon the number of patients needed to be medically screened to determine if they meet the criteria for entry into the study and ultimately upon the total number of patients entered into the study to establish the proper doses of the drug for Phase 2 clinical trials.

 

After completion of the Phase 1 clinical trial of LB-100, the Company anticipates that the next step in the clinical development of LB-100 will be to determine its anti-cancer activity in combination with docetaxel, a standard anti-cancer drug currently on the market, against a specific type of human cancer in a Phase 2 clinical trial. Subject to the availability of funds, the Company intends to conduct a randomized clinical trial of docetaxel +/- LB-100 against a common cancer type for which single agent docetaxel is indicated, and to determine the appropriate dose of LB-100 in combination with a second cytotoxic drug for evaluation subsequently in a Phase 2 clinical trial.

 

As a compound moves through the FDA approval process, it becomes an increasingly valuable property, but at a cost of additional investment at each stage. The Company’s approach has been to operate with a minimum of overhead, moving compounds forward as efficiently and inexpensively as possible, and to raise funds to support each of these stages as certain milestones are reached. The commencement of a Phase 1 clinical trial is a milestone in the Company’s goal of developing a successful product platform.

 

Going Concern

 

The Company’s condensed consolidated financial statements have been presented on the basis that it is a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has not generated any revenues from operations to date, and does not expect to do so in the foreseeable future. The Company has experienced recurring operating losses and negative operating cash flows since inception, and has financed its working capital requirements during this period primarily through the recurring sale of its equity securities and the exercise of outstanding warrants. As a result, management believes that there is substantial doubt about the Company’s ability to continue as a going concern.

 

The Company’s ability to continue as a going concern is dependent upon its ability to raise additional capital and to ultimately achieve sustainable revenues and profitable operations. The Company’s condensed consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.

 

At June 30, 2014, the Company had not yet commenced any revenue-generating operations. All activity through June 30, 2014 has been related to the Company’s capital raising efforts and research and development activities. As such, the Company has yet to generate any cash flows from operations, and is dependent on debt and equity funding from both related and unrelated parties to finance its operations.

 

Because the Company is currently engaged in research at an early stage, it will likely take a significant amount of time to develop any product or intellectual property capable of generating revenues. As such, the Company’s business is unlikely to generate any sustainable revenues in the next several years, and may never do so. Even if the Company is able to generate revenues in the future through licensing its technologies or through product sales, there can be no assurance that the Company will be able to achieve positive earnings and cash flows from operations.

 

At June 30, 2014, the Company had cash and money market funds aggregating $1,240,382, the result primarily of $1,412,500 raised by the Company in April 2014 by offering a 50% discount to warrant holders as an inducement to exercise their warrants for cash. The amount and timing of future cash requirements will depend on the pace of the Company’s programs, in particular the completion of the Phase 1 clinical trial of LB-100. The Company believes that it has sufficient funds to continue with the Phase 1 clinical trial of LB-100 and to fund its operating plans through June 30, 2015. Accordingly, the Company will need to raise additional capital in 2015, likely in the form of equity. Market conditions present uncertainty as to the Company’s ability to secure additional funds. There can be no assurances that the Company will be able to secure additional financing on acceptable terms or at all. If cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its technology and product development programs and/or clinical trials, or obtain funds, if available (although there can be no certainty), through strategic alliances that may require the Company to relinquish rights to certain of its products, or to discontinue its operations entirely.

 

After completion of the Phase 1 clinical trial of LB-100, subject to the availability of funds, the Company anticipates that next step would be to determine the anti-cancer activity of LB-100, in combination with a widely used anti-cancer drug, against a specific type of human cancer in a Phase 2 clinical trial. In addition, subject to the availability of funds, the Company intends to continue the two drug development programs currently in process, and expand its patent portfolio, including the maintenance of its applications for international protection of lead compounds of both the LB-100 and LB-200 series.
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Money Market Funds (Details Narrative) (USD $)
Jun. 30, 2014
Dec. 31, 2013
Investments, Debt and Equity Securities [Abstract]    
Money market funds $ 1,193,663 $ 6,135
XML 18 R28.htm IDEA: XBRL DOCUMENT v2.4.0.8
Common Stock and Common Stock Warrants - Schedule of Shares Authorized Under Stock Warrants By Exercise Price Range (Details) (USD $)
Jun. 30, 2014
Warrants Outstanding 2,928,800
Warrants Exercisable 2,807,840
Exercise Price One [Member]
  
Exercise Prices $ 0.500
Warrants Outstanding 1,853,800
Warrants Exercisable 1,732,840
Exercise Price Two [Member]
  
Exercise Prices $ 0.750
Warrants Outstanding 1,075,000
Warrants Exercisable 1,075,000
XML 19 R30.htm IDEA: XBRL DOCUMENT v2.4.0.8
Money Market Funds - Fair Value Assets Measured on Recurring Basis (Details) (Money Market Funds [Member], USD $)
Jun. 30, 2014
Dec. 31, 2013
Assets, fair value disclosure, recurring $ 1,193,663 $ 6,135
Level 1 [Member]
    
Assets, fair value disclosure, recurring 1,193,663 6,135
Level 2 [Member]
    
Assets, fair value disclosure, recurring      
Level 3 [Member]
    
Assets, fair value disclosure, recurring      
XML 20 R31.htm IDEA: XBRL DOCUMENT v2.4.0.8
Related Party Transactions (Details Narrative) (USD $)
 3 Months Ended 6 Months Ended 12 Months Ended 6 Months Ended 0 Months Ended 3 Months Ended 6 Months Ended 3 Months Ended 6 Months Ended 0 Months Ended
Jun. 30, 2014
Dec. 31, 2013
Jun. 30, 2013
Jun. 30, 2014
Jun. 30, 2013
Dec. 31, 2013
Jun. 30, 2014
Theradex Systems, Inc [Member]
Jun. 30, 2014
Ascentage Pharma Group [Member]
Jun. 30, 2014
Agreement With Theradex Systems [Member]
Jun. 30, 2013
Agreement With Theradex Systems [Member]
Jun. 30, 2014
Agreement With Theradex Systems [Member]
Jun. 30, 2013
Agreement With Theradex Systems [Member]
Jun. 30, 2013
Consulting Arrangements [Member]
Jun. 30, 2013
Consulting Arrangements [Member]
Jul. 01, 2014
Consulting Arrangements [Member]
Jan. 31, 2014
Consulting Arrangements [Member]
Dec. 01, 2012
Consulting Arrangements [Member]
May 31, 2012
Consulting Arrangements [Member]
Jun. 18, 2014
Eric Foreman Law Office [Member]
Due to stockholder $ 92,717 $ 92,717   $ 92,717   $ 92,717                          
Officers' compensation 15,000   15,000 30,000 30,000                            
Sub-lease term                                     6 months
Sub-lease base rate per month                                     875
Legal and consulting fees charged to operations for services rendered by Eric Foreman 10,000 12,000   22,000   12,000                          
Annual fee payable, clinical trial                                   25,000  
Annual fee payable, clinical trial, installment amount                             12,500 12,500 12,500 12,500  
Estimated related party debt               64,935                      
Estimated cost paid to related party               38,881                      
Consultancy fees paid                         4,167 10,417          
Fees for services total 6,250     12,500                              
Stock based compensation expense relating to directors officers and other related parties 56,559   38,912 437,187 86,210                            
Estimated Cost Of Clinical Trial Lab       2,000,000                              
Clinical cost charged to operations             452,381   94,008 75,079 173,660 123,862              
Total fees charged to operations for services                 $ 999 $ 0 $ 6,818 $ 7,393              
Percentage of research and development costs                     1.00% 2.00%              
XML 21 R8.htm IDEA: XBRL DOCUMENT v2.4.0.8
Basis of Presentation
 6 Months Ended
Jun. 30, 2014
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Basis of Presentation

1. Basis of Presentation

 

The condensed consolidated financial statements of Lixte Biotechnology Holdings, Inc., a Delaware corporation, and its wholly-owned Delaware subsidiary, Lixte Biotechnology, Inc. (collectively, the “Company”), at June 30, 2014, and for the three months and six months ended June 30, 2014 and 2013, are unaudited. In the opinion of management of the Company, all adjustments (including normal recurring adjustments) have been made that are necessary to present fairly the financial position of the Company as of June 30, 2014, and the results of its operations for the three months and six months ended June 30, 2014 and 2013, and its cash flows for the six months ended June 30, 2014 and 2013. Operating results for the interim periods presented are not necessarily indicative of the results to be expected for a full fiscal year. The condensed balance sheet at December 31, 2013 has been derived from the Company’s audited financial statements at such date.

 

The statements and related notes have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to such rules and regulations. These financial statements should be read in conjunction with the financial statements and other information included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013, as filed with the SEC.

 

As the Company’s has not yet commenced any revenue-generating operations, does not have any cash flows from operations, and is dependent on debt and equity funding to finance its operations, the Company is considered a development stage company.

 

In June 2014, as discussed in Note, 2, the Financial Accounting Standards Board issued new guidance that removed all incremental financial reporting requirements from generally accepted accounting principles in the United States for development stage entities. The Company early adopted this new guidance effective June 30, 2014, as a result of which all inception-to-date financial information and disclosures have been omitted from this report.
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Stock-Based Compensation (Details Narrative) (USD $)
 0 Months Ended 6 Months Ended 12 Months Ended 6 Months Ended 0 Months Ended 3 Months Ended 0 Months Ended 3 Months Ended 6 Months Ended 0 Months Ended 3 Months Ended 6 Months Ended 0 Months Ended 3 Months Ended 6 Months Ended 0 Months Ended 3 Months Ended 6 Months Ended 0 Months Ended 3 Months Ended 6 Months Ended 0 Months Ended 6 Months Ended
Jun. 30, 2011
Jun. 30, 2014
Dec. 31, 2013
Jun. 30, 2014
Consulting Arrangements [Member]
Jan. 28, 2014
Consulting Arrangements [Member]
Jun. 30, 2014
Consulting Arrangements [Member]
Jan. 28, 2014
Consulting Arrangements [Member]
Immediate Vesting [Member]
Jan. 28, 2014
Consulting Arrangements [Member]
Vesting On January 28, 2015 [Member]
Dec. 24, 2013
NDA Agreement [Member]
Jun. 30, 2014
NDA Agreement [Member]
Jun. 30, 2014
NDA Agreement [Member]
Dec. 24, 2013
NDA Agreement [Member]
Immediate Vesting [Member]
Dec. 24, 2013
NDA Agreement [Member]
Vesting On June 24, 2015 [Member]
Dec. 24, 2013
NDA Agreement [Member]
Vesting On June 24, 2016 [Member]
Dec. 24, 2013
NDA Agreement [Member]
Vesting On June 24, 2017 [Member]
Jun. 30, 2011
Dr. Philip F. Palmedo [Member]
Jun. 30, 2014
Dr. Philip F. Palmedo [Member]
Jun. 30, 2013
Dr. Philip F. Palmedo [Member]
Jun. 30, 2014
Dr. Philip F. Palmedo [Member]
Jun. 30, 2013
Dr. Philip F. Palmedo [Member]
Jun. 30, 2011
Dr. Ojima [Member]
Jun. 30, 2014
Dr. Ojima [Member]
Jun. 30, 2013
Dr. Ojima [Member]
Jun. 30, 2014
Dr. Ojima [Member]
Jun. 30, 2013
Dr. Ojima [Member]
Apr. 30, 2011
Dr. Robert B. Royds [Member]
Jun. 30, 2013
Dr. Robert B. Royds [Member]
Jun. 30, 2013
Dr. Robert B. Royds [Member]
Apr. 30, 2011
Dr. Robert B. Royds [Member]
Immediate Vesting [Member]
Apr. 30, 2011
Dr. Robert B. Royds [Member]
Quarterly Vesting Thereafter [Member]
Sep. 16, 2012
Dr. Kathleen P. Mullinix [Member]
Jun. 30, 2014
Dr. Kathleen P. Mullinix [Member]
Jun. 30, 2013
Dr. Kathleen P. Mullinix [Member]
Jun. 30, 2014
Dr. Kathleen P. Mullinix [Member]
Jun. 30, 2013
Dr. Kathleen P. Mullinix [Member]
Sep. 16, 2012
Dr. Kathleen P. Mullinix [Member]
Immediate Vesting [Member]
Sep. 16, 2012
Dr. Kathleen P. Mullinix [Member]
Quarterly Vesting Thereafter [Member]
Jun. 26, 2014
Francis Johnson [Member]
Jun. 26, 2014
Francis Johnson [Member]
Immediate Vesting [Member]
Jun. 30, 2014
Transactions Requiring Re-Evaluation In Prior Periods [Member]
Jun. 30, 2013
Transactions Requiring Re-Evaluation In Prior Periods [Member]
Jun. 30, 2014
Transactions Requiring Re-Evaluation In Prior Periods [Member]
Minimum [Member]
Jun. 30, 2014
Transactions Requiring Re-Evaluation In Prior Periods [Member]
Maximum [Member]
Exercise price per share   $ 0.25             $ 0.13                       $ 0.98         $ 0.98         $ 0.65             $ 0.25     $ 0.98 $ 0.13 $ 0.50
Stock price per share   $ 0.25     $ 0.15       $ 0.13                                 $ 0.98         $ 0.59             $ 0.24   $ 0.15 $ 0.25    
Expected dividend yield   0.00%                                                                           0.00% 0.00%    
Expected volatility   173.00%                                                                           173.00% 167.00%    
Average risk-free interest rate   1.67%                                                                           1.67% 0.30%    
Expected life   5 years                                                                           4 years 6 months 3 years    
Options granted to purchase common stock         4,000,000                     200,000         50,000         200,000                                  
Options exercisable period   2 years 10 months 6 days     5 years       5 years             5 years         5 years         5 years         5 years             5 years          
Options, exercisable price per share   $ 0.670 $ 0.843   $ 0.50                     $ 0.98         $ 0.98                                       $ 0.65    
Options vest 25,000       2,000,000   2,000,000 2,000,000 100,000     25,000 25,000 25,000 25,000           6,250               25,000 25,000 200,000         25,000 25,000   500,000        
Options, fair value $ 196,000       $ 596,400       $ 12,960                       $ 49,000         $ 196,000         $ 118,000             $ 118,650          
Charges to operations   0   112,088 298,200 44,279       921 3,459           0 24,399 0 48,530   0 (2,382) 0 3,357   0 8,548       12,280 14,513 26,899 29,132                
Options, Vesting date               Jan. 28, 2015                                                                      
Total deferred compensation expense for outstanding value of unvested stock options   166,000                                                                                  
Fair market value, per share   $ 0.15 $ 0.13                                                                                
Exercisable but unexercised in-the-money common stock options   0                                                                                  
Intrinsic value attributed to exercisable but unexercised common stock warrants   $ 0                                                                                  
Outstanding options to acquire common stock non-vested   2,075,000                                                                                  
XML 23 R2.htm IDEA: XBRL DOCUMENT v2.4.0.8
Condensed Consolidated Balance Sheets (USD $)
Jun. 30, 2014
Dec. 31, 2013
Current assets:    
Cash $ 46,719 $ 475,019
Money market funds 1,193,663 6,135
Advances on research and development contract services 34,986 33,880
Prepaid expenses and other current assets 26,827 43,006
Total current assets 1,302,195 558,040
Total assets 1,302,195 558,040
Current liabilities:    
Accounts payable and accrued expenses 111,119 107,774
Research and development contract liabilities, including $36,540 and $34,398 to a related party at June 30, 2014 and December 31, 2013, respectively 49,329 47,283
Liquidated damages payable under registration rights agreement 74,000 74,000
Due to stockholder 92,717 92,717
Total current liabilities 327,165 321,774
Commitments and contingencies      
Stockholders' equity:    
Preferred stock, $0.0001 par value; authorized - 10,000,000 shares; issued - none      
Common stock, $0.0001 par value; authorized - 100,000,000 shares; issued and outstanding - 45,483,097 shares and 41,583,097 shares at June 30, 2014 and December 31, 2013, respectively 4,548 4,158
Additional paid-in capital 15,592,596 13,184,081
Accumulated deficit (14,622,114) (12,951,973)
Total stockholders' equity 975,030 236,266
Total liabilities and stockholders' equity $ 1,302,195 $ 558,040
XML 24 R6.htm IDEA: XBRL DOCUMENT v2.4.0.8
Condensed Consolidated Statement of Stockholders' Equity (Unaudited) (USD $)
Common Stock [Member]
Additional Paid-In Capital [Member]
Accumulated Deficit [Member]
Total
Balance at Dec. 31, 2013 $ 4,158 $ 13,184,081 $ (12,951,973) $ 236,266
Balance, shares at Dec. 31, 2013 41,583,097      
Stock-based compensation expense   559,294   559,294
Exercise of stock warrants 390 1,412,110   1,412,500
Exercise of stock warrants, shares 3,900,000      
Fair value of warrant extensions   302,691   302,691
Fair value of warrant discount   134,420   134,420
Net loss     (1,670,141) (1,670,141)
Balance at Jun. 30, 2014 $ 4,548 $ 15,592,596 $ (14,622,114) $ 975,030
Balance, shares at Jun. 30, 2014 45,483,097      
XML 25 R35.htm IDEA: XBRL DOCUMENT v2.4.0.8
Commitments and Contingencies (Details Narrative) (USD $)
 0 Months Ended 3 Months Ended 6 Months Ended 3 Months Ended 6 Months Ended 0 Months Ended 6 Months Ended
Nov. 10, 2008
Sep. 19, 2008
Jun. 30, 2014
Jan. 31, 2014
Jun. 30, 2014
Consulting Agreement [Member]
Dr Von Hoff [Member]
Jun. 30, 2014
Consulting Arrangements [Member]
Dr Von Hoff [Member]
Jun. 30, 2014
Agreement With Theradex Systems [Member]
Jun. 30, 2013
Agreement With Theradex Systems [Member]
Jun. 30, 2014
Agreement With Theradex Systems [Member]
Jun. 30, 2013
Agreement With Theradex Systems [Member]
Mar. 01, 2014
Capital Resources LLC [Member]
Jun. 30, 2014
Theradex Systems, Inc [Member]
Sep. 21, 2012
Agreement With Theradex Systems [Member]
NIH patent license agreement, terms  

The PLA provided for an initial payment of $25,000 to the NIH within 60 days of September 19, 2008, and for a minimum annual royalty of $30,000 on January 1 of each calendar year following the year in which the CRADA is terminated.

                      
Payments to NIH patent license agreement initial payment $ 25,000                        
PLA, minimum annual royalty, amount       30,000                  
Annual fee payable, clinical trial                         2,000,000
Clinical cost charged to operations             94,008 75,079 173,660 123,862   452,381  
Consulting Fees         4,000 8,000              
Payment for cancellation of agreement                     1,500    
Agreement term                     6 months    
Aggregate principal cash obligation and commitments amount     2,205,003                    
Principal cash obligations and commitments, current     $ 232,090                    
XML 26 R22.htm IDEA: XBRL DOCUMENT v2.4.0.8
Commitments and Contingencies (Tables)
 6 Months Ended
Jun. 30, 2014
Commitments and Contingencies Disclosure [Abstract]  
Schedule of Principal Cash Obligations and Commitments

The following table sets forth the Company’s principal cash obligations and commitments for the next five fiscal years as of June 30, 2014 aggregating $2,205,003, of which $232,090 is included in current liabilities in the condensed consolidated balance sheet at June 30, 2014. Amounts included in the 2014 column represent amounts due at June 30, 2014 for the remainder of the 2014 fiscal year ending December 31, 2014.

 

          Payments Due By Year
    Total     2014     2015     2016     2017     2018  
Research and development contracts   $ 43,054     $ 43,054     $ —     $ —     $ —     $ —  
Theradex work order agreement     1,568,945       1,168,945       400,000       —       —       —  
Patent license agreement     150,000       30,000       30,000       30,000       30,000       30,000  
Operating leases     5,250       5,250       —       —       —       —  
Consulting agreements     12,500       12,500       —       —       —       —  
Liquidated damages payable under registration rights agreement     74,000       74,000       —       —       —       —  
Due to stockholder     92,717       92,717       —       —       —       —  
Total   $ 1,946,466     $ 1,426,466     $ 430,000     $ 30,000     $ 30,000     $ 30,000  
XML 27 R36.htm IDEA: XBRL DOCUMENT v2.4.0.8
Commitments and Contingencies - Schedule of Principal Cash Obligations and Commitments (Details) (USD $)
Jun. 30, 2014
Dec. 31, 2013
Research and development contracts $ 43,054  
Theradex work order agreement 1,568,945  
Patent license agreement 150,000  
Operating leases 5,250  
Consulting Agreements 12,500  
Liquidated damages payable under registration rights agreement 74,000 74,000
Due to stockholder 92,717  
Total 1,946,466  
Payments Due By 2014 [Member]
    
Research and development contracts 43,054  
Theradex work order agreement 1,168,945  
Patent license agreement 30,000  
Operating leases 5,250  
Consulting Agreements 12,500  
Liquidated damages payable under registration rights agreement 74,000  
Due to stockholder 92,717  
Total 1,426,466  
Payments Due By 2015 [Member]
    
Research and development contracts     
Theradex work order agreement 400,000  
Patent license agreement 30,000  
Operating leases     
Consulting Agreements     
Liquidated damages payable under registration rights agreement     
Due to stockholder     
Total 430,000  
Payments Due By 2016 [Member]
    
Research and development contracts     
Theradex work order agreement     
Patent license agreement 30,000  
Operating leases     
Consulting Agreements     
Liquidated damages payable under registration rights agreement     
Due to stockholder     
Total 30,000  
Payments Due By 2017 [Member]
    
Research and development contracts     
Theradex work order agreement     
Patent license agreement 30,000  
Operating leases     
Consulting Agreements     
Liquidated damages payable under registration rights agreement     
Due to stockholder     
Total 30,000  
Payments Due By 2018 [Member]
    
Research and development contracts     
Theradex work order agreement     
Patent license agreement 30,000  
Operating leases     
Consulting Agreements     
Liquidated damages payable under registration rights agreement     
Due to stockholder     
Total $ 30,000  
XML 28 R24.htm IDEA: XBRL DOCUMENT v2.4.0.8
Summary of Significant Accounting Policies (Details Narrative) (USD $)
 3 Months Ended 6 Months Ended
Jun. 30, 2014
Jun. 30, 2013
Jun. 30, 2014
Jun. 30, 2013
Sep. 21, 2012
Patent costs $ 88,055 $ 102,916 $ 155,799 $ 199,595  
Percentage of concentration of risk of general and administrative or research and development costs     10.00%    
Deferred setup and organization costs, amortization period     180 months    
Federal income tax operating loss expiration period     20 years    
Theradex Systems, Inc [Member]
          
Clinical cost charged to operations     452,381    
Agreement With Theradex Systems [Member]
          
Fee payable for clinical trial         2,000,000
Clinical cost charged to operations 94,008 75,079 173,660 123,862  
Percentage of clinical research and development costs   30.00% 35.00% 30.00%  
Total fees charged to operations for services 999 0 6,818 7,393  
Percentage of Additional clinical research and development costs   0.00% 1.00% 2.00%  
Agreement With Ascentage Pharma Group [Member]
          
Clinical cost charged to operations 94,008        
Percentage of clinical research and development costs 28.00%        
Total fees charged to operations for services $ 999        
Percentage of Additional clinical research and development costs 0.00%        
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Condensed Consolidated Statements of Cash Flows (Unaudited) (USD $)
 6 Months Ended
Jun. 30, 2014
Jun. 30, 2013
Cash flows from operating activities:    
Net loss $ (1,670,141) $ (702,753)
Adjustments to reconcile net loss to net cash used in operating activities:    
Stock-based compensation expense included in general and administrative costs 437,185 89,567
Stock-based compensation expense included in research and development costs 122,109   
Fair value of warrant extensions 302,691   
Fair value of warrant discount 134,420   
(Increase) decrease in -    
Advances on research and development contract services (1,106) 9,265
Prepaid expenses and other current assets 16,179 19,350
Increase (decrease) in -    
Accounts payable and accrued expenses 3,345 (14,465)
Research and development contract liabilities 2,046 19,328
Net cash used in operating activities (653,272) (579,708)
Cash flows from investing activities:    
Increase in money market funds (1,187,528) (1)
Net cash used in investing activities (1,187,528) (1)
Cash flows from financing activities:    
Proceeds from exercise of warrants 1,412,500   
Net cash provided by financing activities 1,412,500   
Cash:    
Net decrease (428,300) (579,709)
Balance at beginning of period 475,019 1,655,122
Balance at end of period 46,719 1,075,413
Cash paid for -    
Interest      
Income taxes      
XML 31 R3.htm IDEA: XBRL DOCUMENT v2.4.0.8
Condensed Consolidated Balance Sheets (Parenthetical) (USD $)
Jun. 30, 2014
Dec. 31, 2013
Statement of Financial Position [Abstract]    
Research and development contract liabilities, related parties $ 36,540 $ 34,398
Preferred stock, par value $ 0.0001 $ 0.0001
Preferred stock, shares authorized 10,000,000 10,000,000
Preferred stock, shares issued 0 0
Common stock, par value $ 0.0001 $ 0.0001
Common stock, shares authorized 100,000,000 100,000,000
Common stock, shares issued 45,483,097 41,583,097
Common stock, shares outstanding 45,483,097 41,583,097
XML 32 R17.htm IDEA: XBRL DOCUMENT v2.4.0.8
Summary of Significant Accounting Policies (Policies)
 6 Months Ended
Jun. 30, 2014
Accounting Policies [Abstract]  
Principles of Consolidation

Principles of Consolidation

 

The accompanying condensed consolidated financial statements include the financial statements of Holdings and its wholly-owned subsidiary, Lixte. Intercompany balances and transactions have been eliminated in consolidation.
Cash Concentrations

Cash Concentrations

 

The Company’s cash balances may periodically exceed federally insured limits. The Company has not experienced a loss in such accounts to date. The Company maintains its accounts with financial institutions with high credit ratings. 
Research and Development

Research and Development

 

Research and development costs consist primarily of fees paid to consultants and outside service providers, patent fees and costs, and other expenses relating to the acquisition, design, development and testing of the Company’s treatments and product candidates.

 

Research and development costs are expensed as incurred over the life of the underlying contracts on the straight-line basis, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. Payments made pursuant to research and development contracts are initially recorded as advances on research and development contract services in the Company’s balance sheet and then charged to research and development costs in the Company’s statement of operations as those contract services are performed. Expenses incurred under research and development contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s balance sheet, with a corresponding charge to research and development costs in the Company’s statement of operations. The Company reviews the status of its research and development contracts on a quarterly basis.
Patent Costs

Patent Costs

 

Due to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s research efforts and any related patent applications, all patent costs, including patent-related legal and filing fees, are expensed as incurred. Patent costs were $88,055 and $102,916 for the three months ended June 30, 2014 and 2013, respectively, and $155,799 and $199,595 for the six months ended June 30, 2014 and 2013, respectively. Patent costs are included in research and development costs in the Company’s condensed consolidated statements of operations.
Royalties

Royalties

 

Pursuant to a Patent License Agreement with the NIH that provides the Company with an exclusive license for all patents submitted jointly with the NIH under the CRADA, various categories of royalties at various rates and amounts are payable, including minimum annual royalties (subject to an offset for royalties from net sales), royalties on net sales, royalties based on the achievement of certain benchmarks, and royalties based on granting sublicense agreements, with respect to joint patents. Such royalties are accrued and paid when they become legal obligations, and are charged to general and administrative costs.
Concentration of Risk

Concentration of Risk

 

The Company periodically contracts with directors, including companies controlled by or associated with directors, to provide consulting services related to the Company’s research and development and clinical trial activities. Agreements for these services can be for a specific time period (typically one year) or for a specific project or task, and can include both cash and non-cash compensation. The only such contract that represents 10% or more of general and administrative or research and development costs is described below. 

 

On September 21, 2012, the Company entered into a work order agreement with Theradex, the CRO responsible for the clinical development of the Company’s lead compound, LB-100, to manage and administer the Phase 1 clinical trial of LB-100. The Phase 1 clinical trial of LB-100, which began during April 2013 with the entry of patients into the clinical trial, is being carried out by nationally recognized comprehensive cancer centers, and is estimated to be completed between March and June 2015. The Phase 1 clinical trial is estimated to cost approximately $2,000,000, with such payments expected to be divided approximately evenly between payments to Theradex for services rendered and payments for pass-through costs for the clinical center’s laboratory costs and investigator costs. Total costs charged to operations through June 30, 2014 for services paid to Theradex pursuant to this arrangement, which were first incurred in 2013, total $452,381, of which $94,008 and $75,079 were incurred during the three months ended June 30, 2014 and 2013, respectively, or approximately 28% and 30% of research and development costs for the three months ended June 30, 2014 and 2013, respectively. During the six months ended June 30, 2014 and 2013, the Company incurred $173,660 and $123,862 were incurred during the six months ended June 30, 2014 and 2013, respectively, or approximately 35% and 30% of research and development costs for the six months ended June 30, 2014 and 2013, respectively. The costs charged to operations for amounts paid to Theradex for services relating to the Phase 1 clinical trial of LB-100 are expected to represent a larger percentage of total research and development costs during the fiscal years ending December 31, 2014 and 2015 as compared to prior fiscal years. Costs pursuant to this agreement are included in research and development costs in the Company’s condensed consolidated statements of operations.

 

In addition to the above described agreement with Theradex, the Company has also from time to time engaged Theradex to assist the Company in bringing LB-100 through the FDA approval process and to provide other regulatory services. Total fees charged to operations for services paid to Theradex pursuant to such engagements were $999 and $-0- for the three months ended June 30, 2014 and 2013, respectively, or approximately -0-% and -0-% of research and development costs for the three months ended June 30, 2014 and 2013, respectively and are included in research and development costs in the Company’s condensed consolidated statements of operations. During the six months ended June 30, 2014 and 2013, the Company incurred $6,818 and $7,393, respectively, or approximately 1% and 2% of research and development costs for the six months ended June 30, 2014 and 2013, respectively.
Income Taxes

Income Taxes

 

The Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly, the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and the tax basis of assets and liabilities.

 

The Company has elected to deduct research and development costs on a current basis for federal income tax purposes. For federal tax purposes, start-up and organization costs were deferred until January 1, 2008 at which time the Company began to amortize such costs over a 180-month period.

 

The Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized. In the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of its recorded amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination was made. Likewise, should the Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred tax assets would be charged to operations in the period such determination was made.

 

For federal income tax purposes, net operating losses can be carried forward for a period of 20 years until they are either utilized or until they expire.

 

On January 1, 2007, the Company adopted accounting rules which address the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under these rules, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position are measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement. These accounting rules also provide guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. As of June 30, 2014, no liability for unrecognized tax benefits was required to be recorded.

 

The Company files income tax returns in the U.S. federal jurisdiction and is subject to income tax examinations by federal tax authorities for the year 2009 and thereafter. The Company’s policy is to record interest and penalties on uncertain tax provisions as income tax expense. As of June 30, 2014, the Company has no accrued interest or penalties related to uncertain tax positions.
Stock-Based Compensation

Stock-Based Compensation

 

The Company periodically issues stock options and warrants to officers, directors and consultants for services rendered. Options vest and expire according to terms established at the grant date.

 

The Company accounts for stock-based payments to officers and directors by measuring the cost of services received in exchange for equity awards based on the grant date fair value of the awards, with the cost recognized as compensation expense in the Company’s financial statements on a straight-line basis over the vesting period of the awards.

 

The Company accounts for stock-based payments to consultants by determining the value of the stock compensation based upon the measurement date at either (a) the date at which a performance commitment is reached or (b) at the date at which the necessary performance to earn the equity instruments is complete.

 

Options granted to members of the Company’s Scientific Advisory Committee and to outside consultants are revalued each reporting period to determine the amount to be recorded as an expense in the respective period. As the options vest, they are valued on each vesting date and an adjustment is recorded for the difference between the value already recorded and the then current value on the date of vesting.
Earnings Per Share

Earnings Per Share

 

The Company’s computation of earnings per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as the income (loss) available to common shareholders divided by the weighted average common shares outstanding for the period. Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., warrants and options) as if they had been converted at the beginning of the periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS.

 

Loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the respective periods. Basic and diluted loss per common share is the same for all periods presented because all warrants and stock options outstanding are anti-dilutive.

 

At June 30, 2014 and 2013, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive.

 

    2014     2013  
             
Warrants     2,928,800       6,828,800  
Stock options     7,500,000       3,650,000  
Total     10,428,800       10,478,800  
Fair Value of Financial Instruments

Fair Value of Financial Instruments

 

The authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels, and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair value measurements, is also required.

 

Level 1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities and exchange-based derivatives.

 

Level 2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities, non-exchange based derivatives, mutual funds, and fair-value hedges.

 

Level 3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently-traded non-exchange-based derivatives and commingled investment funds, and are measured using present value pricing models.

 

The Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Company performs an analysis of the assets and liabilities at each reporting period end.

 

Money market funds are the only financial instrument that is measured and recorded at fair value on the Company’s consolidated balance sheet on a recurring basis.
Use of Estimates

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
Recent Accounting Pronouncements

Recent Accounting Pronouncements

 

On June 10, 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update No. 2014-10 (ASU 2014-10), Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation. ASU 2014-10 eliminates the requirement to present inception-to-date information about income statement line items, cash flows, and equity transactions, and clarifies how entities should disclosure the risks and uncertainties related to their activities. ASU 2014-10 also eliminates an exception provided to development stage entities in Consolidations (ASC Topic 810) for determining whether an entity is a variable interest entity on the basis of the amount of investment equity that is at risk. The presentation and disclosure requirements in Topic 915 will no longer be required for interim and annual reporting periods beginning after December 15, 2014, and the revised consolidation standards will take effect in annual periods beginning after December 15, 2015. Early adoption is permitted. The Company adopted the provisions of ASU 2014-10 effective for its financial statements for the interim period ended June 30, 2014, and accordingly, is no longer presenting the inception-to-date financial information and disclosures formerly required.

 

On May 28, 2014, the FASB issued Accounting Standards Update No. 2014-09 (ASU 2014-09), Revenue from Contracts with Customers. ASU 2014-09 will eliminate transaction- and industry-specific revenue recognition guidance under current U.S. GAAP and replace it with a principle based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. ASU 2014-09 is effective for reporting periods beginning after December 15, 2016, and early adoption is not permitted. Entities can transition to the standard either retrospectively or as a cumulative-effect adjustment as of the date of adoption. As the Company does not expect to have any operating revenues for the foreseeable future, the Company does not expect the adoption of this guidance to have any impact on the Company’s consolidated financial statement presentation or disclosures.

 

In April 2014, the FASB issued Accounting Standards Update No. 2014-08 (ASU 2014-08), Presentation of Financial Statements (Topic 205) and Property, Plant and Equipment (Topic 360). ASU 2014-08 amends the requirements for reporting discontinued operations and requires additional disclosures about discontinued operations. Under the new guidance, only disposals representing a strategic shift in operations or that have a major effect on the Company’s operations and financial results should be presented as discontinued operations. This new accounting guidance is effective for annual periods beginning after December 15, 2014. As the Company is engaged in research and development activities and the Company’s planned principal operations have not yet commenced, the Company does not expect the adoption of this guidance to have any impact on the Company’s consolidated financial statement presentation or disclosures.

 

Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the Securities and Exchange Commission did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statement presentation or disclosures. 
XML 33 R1.htm IDEA: XBRL DOCUMENT v2.4.0.8
Document And Entity Information
 6 Months Ended
Jun. 30, 2014
Jul. 31, 2014
Document And Entity Information    
Entity Registrant Name LIXTE BIOTECHNOLOGY HOLDINGS, INC.  
Entity Central Index Key 0001335105  
Document Type 10-Q  
Document Period End Date Jun. 30, 2014  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Entity Filer Category Smaller Reporting Company  
Entity Common Stock, Shares Outstanding   45,483,097
Document Fiscal Period Focus Q2  
Document Fiscal Year Focus 2014  
XML 34 R18.htm IDEA: XBRL DOCUMENT v2.4.0.8
Summary of Significant Accounting Policies (Tables)
 6 Months Ended
Jun. 30, 2014
Accounting Policies [Abstract]  
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share

At June 30, 2014 and 2013, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive.

 

    2014     2013  
             
Warrants     2,928,800       6,828,800  
Stock options     7,500,000       3,650,000  
Total     10,428,800       10,478,800  
XML 35 R4.htm IDEA: XBRL DOCUMENT v2.4.0.8
Condensed Consolidated Statements of Operations (Unaudited) (USD $)
 3 Months Ended 6 Months Ended
Jun. 30, 2014
Jun. 30, 2013
Jun. 30, 2014
Jun. 30, 2013
Income Statement [Abstract]        
Revenues            
Costs and expenses:        
General and administrative costs, including $62,809 and $38,912 to related parties for the three months ended June 30, 2014 and 2013, respectively, and $449,687 and $86,210 for the six months ended June 30, 2014 and 2013, respectively 181,557 120,013 734,566 287,655
Research and development costs, including $101,008 and $78,979 to related parties for the three months ended June 30, 2014 and 2013, respectively, and $186,478 and $141,405 for the six months ended June 30, 2014 and 2013, respectively 335,723 248,795 498,493 415,099
Total costs and expenses 517,280 368,808 1,233,059 702,754
Loss from operations (517,280) (368,808) (1,233,059) (702,754)
Interest income 28 1 29 1
Fair value of warrant extensions (224,074)    (302,691)   
Fair value of warrant discount       (134,420)   
Net loss $ (741,326) $ (368,807) $ (1,670,141) $ (702,753)
Net loss per common share - Basic and diluted $ (0.02) $ (0.01) $ (0.04) $ (0.02)
Weighted average common shares outstanding - Basic and diluted 45,018,262 41,583,097 43,310,169 41,583,097
XML 36 R12.htm IDEA: XBRL DOCUMENT v2.4.0.8
Money Market Funds
 6 Months Ended
Jun. 30, 2014
Investments, Debt and Equity Securities [Abstract]  
Money Market Funds

5. Money Market Funds

 

Money market funds at June 30, 2014 and December 31, 2013 consisted of investments in shares of Morgan Stanley New York Municipal Money Market Trust with a market value of $1,193,663 and $6,135, respectively.

 

The Morgan Stanley New York Municipal Money Market Trust is an open-end fund incorporated in the USA. The Fund’s objective is as high level of daily income exempt from federal and New York income tax as is consistent with stability of principal and liquidity. The Fund invests in high quality, short- term municipal obligations that pay interest exempt from federal and NY taxes.

 

The following table presents money market funds at their level within the fair value hierarchy at June 30, 2014 and December 31, 2013.

 

    Total     Level 1     Level 2     Level 3  
                         
June 30, 2014:                        
Money market funds   $ 1,193,663     $ 1,193,663     $ —     $ —  
                                 
December 31, 2013:                                
Money market funds   $ 6,135     $ 6,135     $ —     $ —  
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Common Stock and Common Stock Warrants
 6 Months Ended
Jun. 30, 2014
Common Stock And Common Stock Warrants  
Common Stock and Common Stock Warrants

4. Common Stock and Common Stock Warrants

 

On January 28, 2014, the Company’s Board of Directors extended to June 30, 2014 outstanding warrants to acquire 1,748,800 shares of the Company’s common stock exercisable at $0.50 per share that were issued to investors and the placement agent in connection with private placements that closed on February 10, 2009, March 2, 2009 and April 6, 2009. On September 30, 2012, the Company had previously extended all other outstanding warrants to June 30, 2014. Included in the January 2014 extension were warrants to acquire 815,920 shares of common stock scheduled to expire on February 10, 2014, warrants to acquire 312,880 shares of common stock scheduled to expire on March 2, 2014, and warrants to acquire 620,000 shares of common stock scheduled to expire on April 6, 2014. The difference in the fair value of the warrants immediately before and after the grant of the extensions, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $78,617 (average of $0.04 per share), and such amount was charged to operations on January 28, 2014. The fair value of the warrant extensions was calculated using the following input variables: stock price - $0.15 per share; exercise price - $0.50 per share; expected life – 13 to 153 days; expected volatility – 262%; expected dividend yield - 0%; risk-free interest rate – 1.51%.

 

On January 28, 2014, the Company offered to all of its warrant holders an inducement to exercise early by reducing the exercise price of currently outstanding warrants by 50%, if exercised on a cash basis by April 15, 2014. The exercise prices of the warrants before reduction were $0.50 per share (2,253,800 warrants) and $0.75 per share (4,575,000 warrants). The difference in the fair value of the warrants immediately before and after the grant of the discount, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $134,420 (an average of $0.02 per share), and such amount was charged to operations on January 28, 2014. The fair value of the warrant extensions was calculated using the following input variables: stock price - $0.15 per share; exercise price - $0.50 and $0.75 per share; expected life – 77 days (the period during which the discount was available); expected volatility – 262%; expected dividend yield - 0%; risk-free interest rate – 1.51%.

 

As a result of the discount warrant offer, warrants to acquire 3,900,000 shares of the Company’s common stock were exercised in April 2014 at discounts ranging from $0.25 to $0.375 per share. The exercise of the warrants generated aggregate net proceeds to the Company of $1,412,500.

 

On June 4, 2014, the Company’s Board of Directors extended to March 31, 2015 outstanding warrants to acquire 2,928,800 shares of the Company’s common stock that were issued to investors and the placement agent in connection with private placements that closed on February 10, 2009, March 2, 2009, April 6, 2009 and January 20, 2010, provided that the warrants were exercised in cash. Warrants to acquire 1,853,800 shares of the Company’s common stock were exercisable at $0.50 per share and 1,075,000 were exercisable at $0.75 per share. All warrants extended were scheduled to expire on June 30, 2014. The difference in the fair value of the warrants immediately before and after the grant of the extensions, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $224,074 (average of $0.08 per share), and such amount was charged to operations on June 4, 2014. The fair value of the warrant extensions was calculated using the following input variables: stock price - $0.22 per share; exercise price - $0.50 and $0.75 per share; expected life – 26 to 300 days; expected volatility – 173%; expected dividend yield - 0%; risk-free interest rate – 0.10%.

 

A summary of common stock warrant activity, including warrants to purchase common stock that were issued in conjunction with the Company’s private placements, is presented in the tables below. For presentation purposes, warrants that were extended are considered as outstanding for the entire period in which such extension occurs.

 

                Weighted  
                Average  
          Weighted     Remaining  
    Number     Average     Contractual  
    of     Exercise     Life  
    Shares     Price     (in Years)  
Warrants outstanding at December 31, 2012     6,828,800     $ 0.667          
Issued     —       —          
Exercised     —       —          
Expired     —       —          
Warrants outstanding at December 31, 2013     6,828,800       0.667          
Issued     —       —          
Exercised     (3,900,000 )     0.263          
Expired     —       —          
Warrants outstanding at June 30, 2014     2,928,800     $ 0.592       0.75  
                         
Warrants exercisable at December 31, 2013     6,659,840     $ 0.672          
Warrants exercisable at June 30, 2014     2,807,840     $ 0.596       0.75  

 

The exercise prices of common stock warrants outstanding and exercisable are as follows at June 30, 2014:

 

      Warrants     Warrants  
Exercise     Outstanding     Exercisable  
Prices     (Shares)     (Shares)  
               
$ 0.500       1,853,800       1,732,840  
$ 0.750       1,075,000       1,075,000  
          2,928,800       2,807,840  

 

Based on a fair market value of $0.15 per share on June 30, 2014, there were no exercisable but unexercised in-the-money common stock warrants on that date. Accordingly, there was no intrinsic value attributed to exercisable but unexercised common stock warrants at June 30, 2014.

 

Based on a fair market value of $0.13 per share on December 31, 2013, there were no exercisable but unexercised in-the-money common stock warrants on that date. Accordingly, there was no intrinsic value attributed to exercisable but unexercised common stock warrants at December 31, 2013

 

At June 30, 2014, warrants exercisable do not include warrants to acquire 120,960 shares of common stock that are contingent upon the exercise of warrants contained in units sold as part of the third private placement, as described above.
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Business Operations (Details Narrative) (USD $)
 3 Months Ended 6 Months Ended
Jun. 30, 2014
Jun. 30, 2013
Jun. 30, 2014
Jun. 30, 2013
Estimated cost of clinical trial lab     $ 2,000,000  
Cost incurred due to services 94,008 75,079 173,660 123,862
Cash And Money Market Funds 1,240,382   1,240,382  
Increase in Cash And Money Market Funds     1,412,500  
Discount to warrant holders to exercise their warrants     50.00%  
Theradex Systems, Inc [Member]
        
Cost incurred due to services     $ 452,381  
XML 39 R19.htm IDEA: XBRL DOCUMENT v2.4.0.8
Common Stock and Common Stock Warrants (Tables)
 6 Months Ended
Jun. 30, 2014
Common Stock And Common Stock Warrants  
Schedule of Warrants Outstanding

A summary of common stock warrant activity, including warrants to purchase common stock that were issued in conjunction with the Company’s private placements, is presented in the tables below. For presentation purposes, warrants that were extended are considered as outstanding for the entire period in which such extension occurs.

 

                Weighted  
                Average  
          Weighted     Remaining  
    Number     Average     Contractual  
    of     Exercise     Life  
    Shares     Price     (in Years)  
Warrants outstanding at December 31, 2012     6,828,800     $ 0.667          
Issued     —       —          
Exercised     —       —          
Expired     —       —          
Warrants outstanding at December 31, 2013     6,828,800       0.667          
Issued     —       —          
Exercised     (3,900,000 )     0.263          
Expired     —       —          
Warrants outstanding at June 30, 2014     2,928,800     $ 0.592       0.75  
                         
Warrants exercisable at December 31, 2013     6,659,840     $ 0.672          
Warrants exercisable at June 30, 2014     2,807,840     $ 0.596       0.75  
Schedule of Shares Authorized Under Stock Warrants by Exercise Price Range

The exercise prices of common stock warrants outstanding and exercisable are as follows at June 30, 2014:

 

      Warrants     Warrants  
Exercise     Outstanding     Exercisable  
Prices     (Shares)     (Shares)  
               
$ 0.500       1,853,800       1,732,840  
$ 0.750       1,075,000       1,075,000  
          2,928,800       2,807,840  
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Commitments and Contingencies
 6 Months Ended
Jun. 30, 2014
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

8. Commitments and Contingencies

 

Effective September 19, 2008, the Company entered into a Patent License Agreement (the “PLA”) with the NIH providing the Company with an exclusive license for all patents submitted jointly with the NIH under the CRADA. The PLA provided for an initial payment of $25,000 to the NIH within 60 days of September 19, 2008, and for a minimum annual royalty of $30,000 on January 1 of each calendar year following the year in which the CRADA is terminated. The PLA also provided for the Company to pay (i) specified royalties based on net sales by the Company and its sub-licensees, reduced by the amount of the minimum annual royalty for that year, (ii) certain benchmark royalties upon the achievement of certain clinical benchmarks, and (iii) sublicensing royalties for the granting of sublicenses, with respect to joint patents. The Company paid the initial $25,000 obligation on November 10, 2008, which was charged to general and administrative costs. Due to the termination of the CRADA on April 1, 2013, the Company became obligated for a minimum annual royalty of $30,000 to the NIH beginning in 2014 and each year thereafter. As of January 31, 2014, a minimum royalty of $30,000 was due pursuant to the PLA, which was charged to general and administrative costs on that date and is included in accounts payable and accrued expenses in the accompanying condensed consolidated balance sheet at June 30, 2014. During April 2014, the Company advised the NIH of its intent to terminate this license.

 

Effective October 18, 2013, the Company entered into a Materials Cooperative Research and Development Agreement (M-CRADA) with the National Institute of Neurological Disorders and Stroke of the National Institutes of Health (NINDS, NIH) for a term of four years. The Surgical Neurology Branch of NINDS, NIH will conduct research characterizing a variety of compounds proprietary to the Company, and will examine the compounds’ potential for anti-cancer activity, reducing neurological deficit due to ischemia and brain injury, and stabilizing catalytic function of misfolded proteins for inborn brain diseases. Under an M-CRADA, a party provides research material, in this case proprietary compounds from the Company’s pipeline, for study by scientists at NIH. The exchange of material is for research only and implies no endorsement of the material on the part of either party. Under the M-CRADA the NIH grants a collaborator an exclusive option to elect an exclusive or non-exclusive commercialization license. The M-CRADA does not generate any incremental cost to the Company.

 

On September 21, 2012, the Company entered into a work order agreement with Theradex, the CRO responsible for the clinical development of the Company’s lead compound, LB-100, to manage and administer the Phase 1 clinical trial of LB-100. The Phase 1 clinical trial of LB-100, which began during April 2013 with the entry of patients into the clinical trial, is being carried out by nationally recognized comprehensive cancer centers, and is estimated to be completed between March and June 2015. The Phase 1 clinical trial is estimated to cost approximately $2,000,000, with such payments expected to be divided approximately evenly between payments to Theradex for services rendered and payments for pass-through costs for the clinical center’s laboratory costs and investigator costs. Total costs charged to operations through June 30, 2014 for services paid to Theradex pursuant to this arrangement, which were first incurred in 2013, total $452,381, of which $94,008 and $75,079 were incurred during the three months ended June 30, 2014 and 2013, respectively, and $173,660 and $123,862 were incurred during the six months ended June 30, 2014 and 2013, respectively. Costs pursuant to this agreement are included in research and development costs in the Company’s condensed consolidated statements of operations.

 

On December 24, 2013, the Company entered into an agreement with NDA Consulting Corp. (“NDA”) for consultation and advice in the field of oncology research and drug development. As part of the agreement, NDA agreed to cause its president, Dr. Daniel D. Von Hoff, M.D., to become a member of the Company’s Scientific Advisory Committee. The term of the agreement is for one year and provides for a quarterly cash fee of $4,000. Consulting and advisory fees charged to operations pursuant to this agreement were $4,000 and $8,000 during the three months and six months ended June 30, 2014.

 

On March 1, 2014, the Company entered into an agreement with Pro-Active Capital Resources LLC for various strategic, investor and public relations services. The agreement is for a term of six months, which may be cancelled by either party upon a thirty day notice, and requires a payment of $1,500 per month.

 

The following table sets forth the Company’s principal cash obligations and commitments for the next five fiscal years as of June 30, 2014 aggregating $2,205,003, of which $232,090 is included in current liabilities in the condensed consolidated balance sheet at June 30, 2014. Amounts included in the 2014 column represent amounts due at June 30, 2014 for the remainder of the 2014 fiscal year ending December 31, 2014.

 

          Payments Due By Year
    Total     2014     2015     2016     2017     2018  
Research and development contracts   $ 43,054     $ 43,054     $ —     $ —     $ —     $ —  
Theradex work order agreement     1,568,945       1,168,945       400,000       —       —       —  
Patent license agreement     150,000       30,000       30,000       30,000       30,000       30,000  
Operating leases     5,250       5,250       —       —       —       —  
Consulting agreements     12,500       12,500       —       —       —       —  
Liquidated damages payable under registration rights agreement     74,000       74,000       —       —       —       —  
Due to stockholder     92,717       92,717       —       —       —       —  
Total   $ 1,946,466     $ 1,426,466     $ 430,000     $ 30,000     $ 30,000     $ 30,000  
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Related Party Transactions
 6 Months Ended
Jun. 30, 2014
Related Party Transactions [Abstract]  
Related Party Transactions

6. Related Party Transactions

 

Advances from the Company’s founding stockholder and Chief Executive Officer, Dr. John Kovach, are non-interest bearing and are due on demand. At June 30, 2014 and December 31, 2013, such stockholder advances outstanding and due to Dr. Kovach totaled $92,717.

 

Dr. Kovach was paid a salary of $15,000 for the three months ended June 30, 2014 and 2013, and $30,000 for the six months ended June 30, 2014 and 2013, which amounts are included in general and administrative costs in the Company’s condensed consolidated statements of operations.

 

Dr. Kovach is not involved in other business activities but could, in the future, become involved in other business opportunities that become available. Accordingly, Dr. Kovach may face a conflict in selecting between the Company and his other business interests. The Company has not yet formulated a policy for the resolution of such potential conflicts.

 

The Company’s principal office facilities have been provided without charge by Dr. Kovach. Such costs were not material to the financial statements and, accordingly, have not been reflected therein.

 

On June 18, 2014, the Company entered into a sub-lease agreement for shared office space in New York City with the Eric Forman Law Office, a party providing legal and consulting services to the Company. The sub-lease is for a term of six months at a base rate of $875 per month. Eric Forman is the son-in-law of Gil Schwartzberg, a significant stockholder of and consultant to the Company. Legal and consulting fees charged to operations for services rendered by Eric Forman for the three months and six months ended June 30, 2014 were $10,000 and $22,000, respectively. The Company recognized similar charges aggregating $12,000 for the year ended December 31, 2013, all of which were recorded in the quarter ended December 31, 2013.

 

On May 21, 2012, the Company entered into an agreement with Dr. Mel Sorensen, a former member of the Company’s Board of Directors, for consultation and advice regarding the preparation and strategy for obtaining FDA allowance of a clinical trial of the lead compound of the LB-100 series. The term of the agreement was for the period from May 21, 2012 to May 31, 2013 and provided for a fee of $25,000, payable in two installments of $12,500 on May 21, 2012 and December 1, 2012. Consulting and advisory fees charged to operations pursuant to this agreement was $4,167 and $10,417 for the three months and six months ended June 30, 2013, respectively, and are included in research and development costs in the Company’s condensed consolidated statements of operations. Effective April 16, 2014, Dr. Sorenson resigned from the Company’s Board of Directors for personal reasons.

 

Periodically, the Company has entered into agreements with Ascentage Pharma Group to conduct various studies. As of June 30, 2014, contracts with a total estimated cost of $64,935, of which $38,881 had been paid, were in process. Ascentage Pharma Group is an offshoot of Ascenta Therapeutics, of which Dr. Sorensen is the President and Chief Executive Officer and a director. Ascentage Pharma Group and Ascenta Therapeutics have a continuing business relationship and certain common shareholders. However, Dr. Sorensen does not have any direct business relationship with or ownership in Ascentage Pharma Group.

 

On September 21, 2012, the Company entered into a work order agreement with Theradex, the CRO responsible for the clinical development of the Company’s lead compound, LB-100, to manage and administer the Phase 1 clinical trial of LB-100. The Phase 1 clinical trial of LB-100, which began during April 2013 with the entry of patients into the clinical trial, is being carried out by nationally recognized comprehensive cancer centers, and is estimated to be completed between March and June 2015. The Phase 1 clinical trial is estimated to cost approximately $2,000,000, with such payments expected to be divided approximately evenly between payments to Theradex for services rendered and payments for pass-through costs for the clinical center’s laboratory costs and investigator costs. Total costs charged to operations through June 30, 2014 for services paid to Theradex pursuant to this arrangement, which were first incurred in 2013, total $452,381, of which $94,008 and $75,079 were incurred during the three months ended June 30, 2014 and 2013, respectively, and $173,660 and $123,862 were incurred during the six months ended June 30, 2014 and 2013, respectively,. Costs pursuant to this agreement are included in research and development costs in the Company’s condensed consolidated statements of operations. On May 2, 2011, Dr. Robert B. Royds, the founder, Chairman of the Board and Medical Director of Theradex, was appointed to the Company’s Board of Directors. Dr. Royds died on March 23, 2013. The death of Dr. Royds is not expected to have any impact on the management and administration of the Phase 1 clinical trial of LB-100.

 

In addition to the above described agreement with Theradex, the Company has also from time to time engaged Theradex to assist the Company in bringing LB-100 through the FDA approval process and to provide other regulatory services. Total fees charged to operations for services paid to Theradex pursuant to such engagements were $999 and $-0- for the three months ended June 30, 2014 and 2013, respectively, respectively and are included in research and development costs in the Company’s condensed consolidated statements of operations. During the six months ended June 30, 2014 and 2013, the Company incurred $6,818 and $7,393, respectively, or approximately 1% and 2% of research and development costs for the six months ended June 30, 2014 and 2013, respectively.

 

Effective January 1, 2014, the Company entered into an Advisory Agreement with Dr. Kathleen P. Mullinix, a member of the Board of Directors of the Company, effective for an initial term of one year through December 31, 2014 to advise on business development matters. The initial term and any subsequent one year term shall be automatically extended on an annual basis unless a notice of intent to terminate is given by either party at least 90 days before the end of the applicable term. The Advisory Agreements provides for compensation of $25,000 annually, payable in two installments of $12,500, with the first payment due on January 31, 2014 and the second payment due on July 1, 2014. Total fees charged to operations for services paid to pursuant to this agreement were $6,250 and $12,500 for the three months and six months ended June 30, 2014, respectively, and are included in general and administrative costs in the Company’s condensed consolidated statements of operations.

 

Stock-based compensation arrangements involving members of the Company’s Board of Directors are described at Note 7. Total stock-based compensation expense relating to directors, officers and other related parties was $56,559 and $38,912 for the three months ended June 30, 2014 and 2013, respectively, and $437,187 and $86,210 for the six months ended June 30, 2014 and 2013, respectively.
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Stock-Based Compensation
 6 Months Ended
Jun. 30, 2014
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]  
Stock-Based Compensation

7. Stock-Based Compensation

 

The Company grants stock options as incentive compensation to directors and as compensation for the services of independent contractors and consultants of the Company.

 

The fair value of each option awarded is estimated on the date of grant and subsequent measurement dates using the Black-Scholes option-pricing model. The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options. In addition, option valuation models require the input of highly subjective assumptions including the expected stock price volatility. Because the Company’s stock options have characteristics significantly different from those of traded options, and because changes in the subjective assumptions can materially affect the fair value estimate, in management’s opinion, the existing models do not necessarily provide a reliable single measure of the fair value of its stock options. The expected dividend yield assumption is based on the Company’s expectation of dividend payouts. Expected volatilities are based on historical volatility of the Company’s stock. The risk-free interest rate is based on the U.S. treasury yield curve in effect as of the grant date. Expected life of the options is the average of the vesting term and the full contractual term of the options.

 

New transactions during the six months ended June 30, 2014 that required an assessment of value pursuant to the Black-Scholes option-pricing model utilized the following inputs: exercise price per share - $0.25; stock price per share – $0.25; expected dividend yield – 0.00%; expected volatility – 173%; average risk-free interest rate – 1.67%; expected life – 5 years. For the purpose of assessing value for transactions requiring re-evaluation at June 30, 2014, the Black-Scholes option-pricing model utilized the following inputs: exercise price per share - $0.13 to $0.50; stock price per share – $0.15; expected dividend yield – 0.00%; expected volatility – 173%; average risk-free interest rate – 1.67%; expected life – 4.5 years.

 

There were no new transactions during the six months ended June 30, 2013 that required an assessment of value pursuant to the Black-Scholes option-pricing model. For the purpose of assessing value for transactions requiring re-evaluation at June 30, 2013 that were entered into in prior periods, the Black-Scholes option-pricing model utilized the following inputs: exercise price per share - $0.98; stock price per share – $0.25; expected dividend yield – 0.00%; expected volatility – 167%; average risk-free interest rate – 0.30%; expected life – 3.0 years.

 

On June 30, 2011, the Company granted to Dr. Philip F. Palmedo, a director of the Company, stock options to purchase 200,000 shares of common stock, exercisable for a period of five years from the date of grant at $0.98 per share, which was the fair market value of the Company’s common stock on such date. The options vest ratably in equal quarterly installments of 25,000 shares beginning July 1, 2011. The fair value of these options, as calculated pursuant to the Black-Scholes option-pricing model, was initially determined to be $196,000 ($0.98 per share). During the three months ended June 30, 2014 and 2013, the Company recorded charges to operations of $-0- and $24,399, respectively, with respect to these options. During the six months ended June 30, 2014 and 2013, the Company recorded charges to operations of $-0- and $48,530, respectively, with respect to these options.

 

On June 30, 2011, the Company granted to Dr. Iwao Ojima stock options to purchase 50,000 shares of common stock, exercisable for a period of five years from the date of grant at $0.98 per share, which was the fair market value of the Company’s common stock on such date. The options vest ratably in equal quarterly installments of 6,250 shares beginning July 1, 2011. The fair value of these options, as calculated pursuant to the Black-Scholes option-pricing model, was initially determined to be $49,000 ($0.98 per share). During the three months ended June 30, 2014 and 2013, the Company charged (credited) operations of $-0- and ($2,382), respectively, with respect to these options. During the six months ended June 30, 2014 and 2013, the Company recorded charges to operations of $-0- and $3,357, respectively, with respect to these options.

 

On January 28, 2014, the Company approved a second amendment to the Company’s consulting agreement with Gil Schwartzberg dated September 12, 2007 to extend it an additional four years to January 28, 2019 and granted to Mr. Schwartzberg stock options to purchase an additional aggregate of 4,000,000 shares of common stock, exercisable for a period of the earlier of five years from the grant date or the termination of the consulting agreement at $0.50 per share, with one-half of the options (2,000,000 shares) vesting immediately and one-half of the options (2,000,000 shares) vesting on January 28, 2015. The fair value of these options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $596,400 ($0.15 per share) on January 28, 2014, of which $298,200 is attributed to the options fully-vested on January 28, 2014 and as such was charged to operations on that date. The remaining unvested portion of the fair value of the options will be charged to operations ratably from January 28, 2014 through January 28, 2015. During the three months and six months ended June 30, 2014, the Company recorded charges to operations of $44,279 and $112,088 with respect to the remaining unvested portion of the options.

 

Effective May 1, 2011, in connection with his election to the Company’s Board of Directors, Dr. Robert B. Royds was granted stock options to purchase 200,000 shares of the Company’s common stock, vesting 25,000 shares on May 1, 2011, and 25,000 shares quarterly thereafter until all of the shares are vested, exercisable for a period of five years from each tranche’s vesting date, at $0.98 per share, which was the fair market value of the Company’s common stock on such date. The fair value of these options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $196,000 ($0.98 per share), and was charged to operations ratably from May 2, 2011 through February 1, 2013. During the three months and six months ended June 30, 2013, the Company recorded charges to operations of $0 and $8,548, respectively, with respect to these options. Dr. Royds died on March 23, 2013. The stock options expired unexercised.

 

Effective September 16, 2012, in connection with her election to the Company’s Board of Directors, Dr. Kathleen P. Mullinix was granted stock options to purchase 200,000 shares of the Company’s common stock, vesting 25,000 shares on September 16, 2012, and 25,000 shares quarterly thereafter until all of the shares are vested, exercisable for a period of five years from the date of grant at $0.65 per share, which was the fair market value of the Company’s common stock on such date. The fair value of these options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $118,000 ($0.59 per share), and is being charged to operations from September 16, 2012 through June 16, 2014. During the three months ended June 30, 2014 and 2013, the Company recorded charges to operations of $12,280 and $14,513, respectively, with respect to these options. During the six months ended June 30, 2014 and 2013, the Company recorded charges to operations of $26,899 and $29,132, respectively, with respect to these options.

 

On December 24, 2013, the Company entered into an agreement with NDA Consulting Corp. (“NDA”) for consultation and advice in the field of oncology research and drug development. As part of the agreement, NDA agreed to cause its president, Dr. Daniel D. Von Hoff, M.D., to become a member of the Company’s Scientific Advisory Committee. In connection with this agreement, NDA was granted stock options to purchase 100,000 shares of the Company’s common stock, vesting 25,000 shares on June 24, 2014, and thereafter 25,000 shares annually on June 24, 2015, 2016 and 2017, exercisable for a period of five years from the date of grant at $0.13 per share, which was the fair market value of the Company’s common stock on the grant date. The fair value of these options, as calculated pursuant to the Black-Scholes option-pricing model, was initially determined to be $12,960 ($0.13 per share), and is being charged to operations from December 24, 2013 through June 24, 2017. During the three months and six months ended June 30, 2014, the Company recorded charges to operations of $921 and $3,459, respectively, with respect to these options.

 

On June 26, 2014, the Company granted to Francis Johnson, a consultant to the Company and a co-owner of Chem-Master International, Inc., a vendor of the Company, immediately vesting stock options to purchase 500,000 shares of common stock, exercisable for a period of five years from the grant date at $0.25 per share. The fair value of these options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $118,650 ($0.24 per share), which was charged to operations on that date. The options were granted to Mr. Johnson as compensation for his contributions to the Company’s compound development activities.

 

A summary of stock option activity is presented in the tables below.

 

                Weighted  
                Average  
          Weighted     Remaining  
    Number     Average     Contractual  
    of     Exercise     Life  
    Shares     Price     (in Years)  
Options outstanding at December 31, 2012     3,750,000     $ 0.870          
Granted     100,000       0.130          
Exercised     —       —          
Expired     (700,000 )     1.045          
Options outstanding at December 31, 2013     3,150,000       0.818          
Granted     4,500,000       0.472          
Exercised     —       —          
Expired     (150,000 )     0.327          
Options outstanding at June 30, 2014     7,500,000     $ 0.619       3.68  
                         
Options exercisable at December 31, 2013     3,000,000     $ 0.843          
Options exercisable at June 30, 2014     5,425,000     $ 0.670       2.85  

 

Total deferred compensation expense for the outstanding value of unvested stock options was approximately $166,000 at June 30, 2014, which is being recognized subsequent to June 30, 2014 over a weighted-average period of approximately six months.

 

The exercise prices of common stock options outstanding and exercisable are as follows at June 30, 2014: 

 

      Options     Options  
Exercise     Outstanding     Exercisable  
Prices     (Shares)     (Shares)  
               
$ 0.130       100,000       25,000  
$ 0.250       500,000       500,000  
$ 0.333       100,000       100,000  
$ 0.500       4,150,000       2,150,000  
$ 0.650       700,000       700,000  
$ 0.980       450,000       450,000  
$ 1.000       1,500,000       1,500,000  
          7,500,000       5,425,000  

 

Based on a fair market value of $0.15 per share on June 30, 2014, there were no exercisable but unexercised in-the-money common stock options on that date. Accordingly, there was no intrinsic value attributed to exercisable but unexercised common stock warrants at June 30, 2014.

 

Based on a fair market value of $0.13 per share on December 31, 2013, there were no exercisable but unexercised in-the-money stock options on that date. Accordingly, there was no intrinsic value attributed to exercisable but unexercised stock options at December 31, 2013. 

 

Outstanding options to acquire 2,075,000 shares of the Company’s common stock had not vested at June 30, 2014.

 

The Company expects to satisfy such stock obligations through the issuance of authorized but unissued shares of common stock.
XML 43 R16.htm IDEA: XBRL DOCUMENT v2.4.0.8
Subsequent Events
 6 Months Ended
Jun. 30, 2014
Subsequent Events [Abstract]  
Subsequent Events

9. Subsequent Events

 

On July 15, 2014, Gil Schwartzberg, a significant stockholder of and consultant to the Company, assigned fully-vested stock options to acquire 1,000,000 shares of the Company’s common stock to Daniel Von Hoff, a member of the Company’s Scientific Advisory Committee. The options assigned included options to acquire 500,000 shares that had been previously granted to Mr. Schwartzberg on October 15, 2009, are exercisable at $1.00 per share, and expire on October 15, 2014, and options for 500,000 shares that had been previously granted to Mr. Schwartzberg on October 5, 2011, are exercisable at $1.00 per share, and expire on October 5, 2016. As Mr. Schwartzberg is considered an affiliate of the Company for accounting and securities purposes, the fair value of the stock options assigned by Mr. Schwartzberg to Mr. Von Hoff for the benefit of the Company will be recorded as a contribution to capital and a charge to operations. The fair value of the options assigned, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $43,500 (average of $0.04 per share), and such amount will be charged to operations on July 15, 2014. The fair value of the options assigned was calculated using the following input variables: stock price - $0.15 per share; exercise price - $1.00 per share; expected life – 92 and 812 days; expected volatility – 173%; expected dividend yield - 0%; risk-free interest rate – 0.03% and 0.49%.
XML 44 R34.htm IDEA: XBRL DOCUMENT v2.4.0.8
Stock-Based Compensation - Exercise Prices of Common Stock Options Outstanding and Exercisable (Details) (USD $)
Jun. 30, 2014
Dec. 31, 2013
Dec. 31, 2012
Exercise Prices $ 0.619 $ 0.818 $ 0.870
Options Outstanding (Shares) 7,500,000    
Options Exercisable (Shares) 5,425,000    
Exercise Price Three [Member]
      
Exercise Prices $ 0.333    
Options Outstanding (Shares) 100,000    
Options Exercisable (Shares) 100,000    
Exercise Price Four [Member]
      
Exercise Prices $ 0.500    
Options Outstanding (Shares) 4,150,000    
Options Exercisable (Shares) 2,150,000    
Exercise Price Five [Member]
      
Exercise Prices $ 0.650    
Options Outstanding (Shares) 700,000    
Options Exercisable (Shares) 700,000    
Exercise Price Six [Member]
      
Exercise Prices $ 0.980    
Options Outstanding (Shares) 450,000    
Options Exercisable (Shares) 450,000    
Exercise Price Seven [Member]
      
Exercise Prices $ 1.000    
Options Outstanding (Shares) 1,500,000    
Options Exercisable (Shares) 1,500,000    
Exercise Price One [Member]
      
Exercise Prices $ 0.130    
Options Outstanding (Shares) 100,000    
Options Exercisable (Shares) 25,000    
Exercise Price Two [Member]
      
Exercise Prices $ 0.250    
Options Outstanding (Shares) 500,000    
Options Exercisable (Shares) 500,000    
XML 45 R21.htm IDEA: XBRL DOCUMENT v2.4.0.8
Stock-Based Compensation (Tables)
 6 Months Ended
Jun. 30, 2014
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]  
Summary of Stock Option Activity

A summary of stock option activity is presented in the tables below.

 

                Weighted  
                Average  
          Weighted     Remaining  
    Number     Average     Contractual  
    of     Exercise     Life  
    Shares     Price     (in Years)  
Options outstanding at December 31, 2012     3,750,000     $ 0.870          
Granted     100,000       0.130          
Exercised     —       —          
Expired     (700,000 )     1.045          
Options outstanding at December 31, 2013     3,150,000       0.818          
Granted     4,500,000       0.472          
Exercised     —       —          
Expired     (150,000 )     0.327          
Options outstanding at June 30, 2014     7,500,000     $ 0.619       3.68  
                         
Options exercisable at December 31, 2013     3,000,000     $ 0.843          
Options exercisable at June 30, 2014     5,425,000     $ 0.670       2.85  
Exercise Prices of Common Stock Options Outstanding and Exercisable

The exercise prices of common stock options outstanding and exercisable are as follows at June 30, 2014: 

 

      Options     Options  
Exercise     Outstanding     Exercisable  
Prices     (Shares)     (Shares)  
               
$ 0.130       100,000       25,000  
$ 0.250       500,000       500,000  
$ 0.333       100,000       100,000  
$ 0.500       4,150,000       2,150,000  
$ 0.650       700,000       700,000  
$ 0.980       450,000       450,000  
$ 1.000       1,500,000       1,500,000  
          7,500,000       5,425,000  
XML 46 R26.htm IDEA: XBRL DOCUMENT v2.4.0.8
Common Stock and Common Stock Warrants (Details Narrative) (USD $)
 0 Months Ended 6 Months Ended 6 Months Ended 0 Months Ended 6 Months Ended 0 Months Ended 6 Months Ended 0 Months Ended 6 Months Ended 0 Months Ended 6 Months Ended
Jan. 28, 2014
Jun. 30, 2014
Jun. 30, 2013
Dec. 31, 2013
Jun. 30, 2014
Minimum [Member]
Jun. 30, 2014
Maximum [Member]
Jan. 28, 2014
Warrants One [Member]
Jan. 31, 2014
Warrants Two [Member]
Jun. 30, 2014
Warrants Three [Member]
Jun. 30, 2014
Warrants Four [Member]
Jan. 28, 2014
Warrants Extensions One [Member]
Jun. 30, 2014
Warrants Extensions One [Member]
Jun. 30, 2014
Warrants Extensions One [Member]
Minimum [Member]
Jun. 30, 2014
Warrants Extensions One [Member]
Maximum [Member]
Jan. 28, 2014
Warrants Extensions Two [Member]
Jun. 30, 2014
Warrants Extensions Two [Member]
Jun. 30, 2014
Warrants Extensions Two [Member]
Minimum [Member]
Jun. 30, 2014
Warrants Extensions Two [Member]
Maximum [Member]
Jun. 04, 2014
Warrants Five [Member]
Jun. 30, 2014
Warrants Six [Member]
Jun. 30, 2014
Warrant Seven [Member]
Jun. 30, 2014
Warrants Extensions Three [Member]
Jun. 30, 2014
Warrants Extensions Three [Member]
Minimum [Member]
Jun. 30, 2014
Warrants Extensions Three [Member]
Maximum [Member]
Share issued during period for outstanding warrants acquire             1,748,800 815,920 312,880 620,000                 2,928,800 1,853,800 1,075,000      
Common stock exercisable price per share             $ 0.50                         $ 0.50 $ 0.75      
Warrants acquisition expiration date               Feb. 10, 2014 Mar. 02, 2014 Apr. 06, 2014                   Jun. 30, 2014 Jun. 30, 2014      
Fair value of warrants extensions amount                     $ 78,617       $ 134,420             $ 224,074    
Warrants extensions average price per share                     $ 0.04       $ 0.02             $ 0.08    
Fair value assumption stock price                       $ 0.15       $ 0.15           $ 0.22 $ 0.50 $ 0.75
Fair value assumptions, exercise price                       $ 0.50         $ 0.50 $ 0.75            
Fair value assumptions, expected term                         13 days 153 days   77 days             26 days 300 days
Fair value assumptions, expected volatility rate                       262.00%       262.00%           173.00%    
Fair value assumptions, expected dividend rate                       0.00%       0.00%           0.00%    
Fair value assumptions, risk free interest rate                       1.51%       1.51%           0.10%    
Percentage of reducing exercise price for currently outstanding warrants 50.00%                                              
Exercise prices of the warrants before reduction description

The exercise prices of the warrants before reduction were $0.50 per share (2,253,800 warrants) and $0.75 per share (4,575,000 warrants).

                                              
Number of shares issued under discount warrant offer for acquire warrants   3,900,000                                            
Warrants exercised at discount price range         $ 0.25 $ 0.375                                    
Proceeds from exercise of warrants   $ 1,412,500                                             
Stock Options and warrants exercisable fair market value   $ 0.15   $ 0.13                                        
Number of warrants exercisable excluded warrants to acquire   120,960                                            
XML 47 R5.htm IDEA: XBRL DOCUMENT v2.4.0.8
Condensed Consolidated Statements of Operations (Unaudited) (Parenthetical) (USD $)
 3 Months Ended 6 Months Ended
Jun. 30, 2014
Jun. 30, 2013
Jun. 30, 2014
Jun. 30, 2013
Income Statement [Abstract]        
General and administrative costs, to related parties $ 62,809 $ 38,912 $ 449,687 $ 86,210
Research and development costs, to related parties $ 101,008 $ 78,979 $ 186,478 $ 141,405
XML 48 R10.htm IDEA: XBRL DOCUMENT v2.4.0.8
Summary of Significant Accounting Policies
 6 Months Ended
Jun. 30, 2014
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies

3. Summary of Significant Accounting Policies

 

Principles of Consolidation

 

The accompanying condensed consolidated financial statements include the financial statements of Holdings and its wholly-owned subsidiary, Lixte. Intercompany balances and transactions have been eliminated in consolidation.

 

Cash Concentrations

 

The Company’s cash balances may periodically exceed federally insured limits. The Company has not experienced a loss in such accounts to date. The Company maintains its accounts with financial institutions with high credit ratings. 

 

Research and Development

 

Research and development costs consist primarily of fees paid to consultants and outside service providers, patent fees and costs, and other expenses relating to the acquisition, design, development and testing of the Company’s treatments and product candidates.

 

Research and development costs are expensed as incurred over the life of the underlying contracts on the straight-line basis, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. Payments made pursuant to research and development contracts are initially recorded as advances on research and development contract services in the Company’s balance sheet and then charged to research and development costs in the Company’s statement of operations as those contract services are performed. Expenses incurred under research and development contracts in excess of amounts advanced are recorded as research and development contract liabilities in the Company’s balance sheet, with a corresponding charge to research and development costs in the Company’s statement of operations. The Company reviews the status of its research and development contracts on a quarterly basis.

 

Patent Costs

 

Due to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s research efforts and any related patent applications, all patent costs, including patent-related legal and filing fees, are expensed as incurred. Patent costs were $88,055 and $102,916 for the three months ended June 30, 2014 and 2013, respectively, and $155,799 and $199,595 for the six months ended June 30, 2014 and 2013, respectively. Patent costs are included in research and development costs in the Company’s condensed consolidated statements of operations.

 

Royalties

 

Pursuant to a Patent License Agreement with the NIH that provides the Company with an exclusive license for all patents submitted jointly with the NIH under the CRADA, various categories of royalties at various rates and amounts are payable, including minimum annual royalties (subject to an offset for royalties from net sales), royalties on net sales, royalties based on the achievement of certain benchmarks, and royalties based on granting sublicense agreements, with respect to joint patents. Such royalties are accrued and paid when they become legal obligations, and are charged to general and administrative costs.

 

Concentration of Risk

 

The Company periodically contracts with directors, including companies controlled by or associated with directors, to provide consulting services related to the Company’s research and development and clinical trial activities. Agreements for these services can be for a specific time period (typically one year) or for a specific project or task, and can include both cash and non-cash compensation. The only such contract that represents 10% or more of general and administrative or research and development costs is described below. 

 

On September 21, 2012, the Company entered into a work order agreement with Theradex, the CRO responsible for the clinical development of the Company’s lead compound, LB-100, to manage and administer the Phase 1 clinical trial of LB-100. The Phase 1 clinical trial of LB-100, which began during April 2013 with the entry of patients into the clinical trial, is being carried out by nationally recognized comprehensive cancer centers, and is estimated to be completed between March and June 2015. The Phase 1 clinical trial is estimated to cost approximately $2,000,000, with such payments expected to be divided approximately evenly between payments to Theradex for services rendered and payments for pass-through costs for the clinical center’s laboratory costs and investigator costs. Total costs charged to operations through June 30, 2014 for services paid to Theradex pursuant to this arrangement, which were first incurred in 2013, total $452,381, of which $94,008 and $75,079 were incurred during the three months ended June 30, 2014 and 2013, respectively, or approximately 28% and 30% of research and development costs for the three months ended June 30, 2014 and 2013, respectively. During the six months ended June 30, 2014 and 2013, the Company incurred $173,660 and $123,862 were incurred during the six months ended June 30, 2014 and 2013, respectively, or approximately 35% and 30% of research and development costs for the six months ended June 30, 2014 and 2013, respectively. The costs charged to operations for amounts paid to Theradex for services relating to the Phase 1 clinical trial of LB-100 are expected to represent a larger percentage of total research and development costs during the fiscal years ending December 31, 2014 and 2015 as compared to prior fiscal years. Costs pursuant to this agreement are included in research and development costs in the Company’s condensed consolidated statements of operations.

 

In addition to the above described agreement with Theradex, the Company has also from time to time engaged Theradex to assist the Company in bringing LB-100 through the FDA approval process and to provide other regulatory services. Total fees charged to operations for services paid to Theradex pursuant to such engagements were $999 and $-0- for the three months ended June 30, 2014 and 2013, respectively, or approximately -0-% and -0-% of research and development costs for the three months ended June 30, 2014 and 2013, respectively and are included in research and development costs in the Company’s condensed consolidated statements of operations. During the six months ended June 30, 2014 and 2013, the Company incurred $6,818 and $7,393, respectively, or approximately 1% and 2% of research and development costs for the six months ended June 30, 2014 and 2013, respectively.

 

Income Taxes

 

The Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly, the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and the tax basis of assets and liabilities.

 

The Company has elected to deduct research and development costs on a current basis for federal income tax purposes. For federal tax purposes, start-up and organization costs were deferred until January 1, 2008 at which time the Company began to amortize such costs over a 180-month period.

 

The Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized. In the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of its recorded amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination was made. Likewise, should the Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred tax assets would be charged to operations in the period such determination was made.

 

For federal income tax purposes, net operating losses can be carried forward for a period of 20 years until they are either utilized or until they expire.

 

On January 1, 2007, the Company adopted accounting rules which address the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under these rules, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position are measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement. These accounting rules also provide guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. As of June 30, 2014, no liability for unrecognized tax benefits was required to be recorded.

 

The Company files income tax returns in the U.S. federal jurisdiction and is subject to income tax examinations by federal tax authorities for the year 2009 and thereafter. The Company’s policy is to record interest and penalties on uncertain tax provisions as income tax expense. As of June 30, 2014, the Company has no accrued interest or penalties related to uncertain tax positions.

 

Stock-Based Compensation

 

The Company periodically issues stock options and warrants to officers, directors and consultants for services rendered. Options vest and expire according to terms established at the grant date.

 

The Company accounts for stock-based payments to officers and directors by measuring the cost of services received in exchange for equity awards based on the grant date fair value of the awards, with the cost recognized as compensation expense in the Company’s financial statements on a straight-line basis over the vesting period of the awards.

 

The Company accounts for stock-based payments to consultants by determining the value of the stock compensation based upon the measurement date at either (a) the date at which a performance commitment is reached or (b) at the date at which the necessary performance to earn the equity instruments is complete.

 

Options granted to members of the Company’s Scientific Advisory Committee and to outside consultants are revalued each reporting period to determine the amount to be recorded as an expense in the respective period. As the options vest, they are valued on each vesting date and an adjustment is recorded for the difference between the value already recorded and the then current value on the date of vesting.

 

Earnings Per Share

 

The Company’s computation of earnings per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as the income (loss) available to common shareholders divided by the weighted average common shares outstanding for the period. Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., warrants and options) as if they had been converted at the beginning of the periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS.

 

Loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the respective periods. Basic and diluted loss per common share is the same for all periods presented because all warrants and stock options outstanding are anti-dilutive.

 

At June 30, 2014 and 2013, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive.

 

    2014     2013  
             
Warrants     2,928,800       6,828,800  
Stock options     7,500,000       3,650,000  
Total     10,428,800       10,478,800  

 

Fair Value of Financial Instruments

 

The authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels, and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair value measurements, is also required.

 

Level 1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities and exchange-based derivatives.

 

Level 2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities, non-exchange based derivatives, mutual funds, and fair-value hedges.

 

Level 3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently-traded non-exchange-based derivatives and commingled investment funds, and are measured using present value pricing models.

 

The Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Company performs an analysis of the assets and liabilities at each reporting period end.

 

Money market funds are the only financial instrument that is measured and recorded at fair value on the Company’s consolidated balance sheet on a recurring basis.

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

 

Recent Accounting Pronouncements

 

On June 10, 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update No. 2014-10 (ASU 2014-10), Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation. ASU 2014-10 eliminates the requirement to present inception-to-date information about income statement line items, cash flows, and equity transactions, and clarifies how entities should disclosure the risks and uncertainties related to their activities. ASU 2014-10 also eliminates an exception provided to development stage entities in Consolidations (ASC Topic 810) for determining whether an entity is a variable interest entity on the basis of the amount of investment equity that is at risk. The presentation and disclosure requirements in Topic 915 will no longer be required for interim and annual reporting periods beginning after December 15, 2014, and the revised consolidation standards will take effect in annual periods beginning after December 15, 2015. Early adoption is permitted. The Company adopted the provisions of ASU 2014-10 effective for its financial statements for the interim period ended June 30, 2014, and accordingly, is no longer presenting the inception-to-date financial information and disclosures formerly required.

 

On May 28, 2014, the FASB issued Accounting Standards Update No. 2014-09 (ASU 2014-09), Revenue from Contracts with Customers. ASU 2014-09 will eliminate transaction- and industry-specific revenue recognition guidance under current U.S. GAAP and replace it with a principle based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. ASU 2014-09 is effective for reporting periods beginning after December 15, 2016, and early adoption is not permitted. Entities can transition to the standard either retrospectively or as a cumulative-effect adjustment as of the date of adoption. As the Company does not expect to have any operating revenues for the foreseeable future, the Company does not expect the adoption of this guidance to have any impact on the Company’s consolidated financial statement presentation or disclosures.

 

In April 2014, the FASB issued Accounting Standards Update No. 2014-08 (ASU 2014-08), Presentation of Financial Statements (Topic 205) and Property, Plant and Equipment (Topic 360). ASU 2014-08 amends the requirements for reporting discontinued operations and requires additional disclosures about discontinued operations. Under the new guidance, only disposals representing a strategic shift in operations or that have a major effect on the Company’s operations and financial results should be presented as discontinued operations. This new accounting guidance is effective for annual periods beginning after December 15, 2014. As the Company is engaged in research and development activities and the Company’s planned principal operations have not yet commenced, the Company does not expect the adoption of this guidance to have any impact on the Company’s consolidated financial statement presentation or disclosures.

 

Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the Securities and Exchange Commission did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statement presentation or disclosures. 
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Common Stock and Common Stock Warrants - Schedule of Warrants Outstanding (Details) (Warrant [Member], USD $)
 6 Months Ended 12 Months Ended
Jun. 30, 2014
Dec. 31, 2013
Warrant [Member]
    
Number of Shares, Outstanding, Beginning Balance 6,828,800 6,828,800
Number of Shares, Issued      
Number of Shares, Exercised (3,900,000)   
Number of Shares, Expired      
Number of Shares, Outstanding, Ending Balance 2,928,800 6,828,800
Warrants Exercisable 2,807,840 6,659,840
Weighted Average Exercise Price, Outstanding, Beginning $ 0.667 $ 0.667
Weighted Average Exercise Price, Issued      
Weighted Average Exercise Price, Exercised $ 0.263   
Weighted Average Exercise Price, Expired      
Weighted Average Exercise Price, Outstanding, Ending $ 0.592 $ 0.667
Weighted Average Exercise Price, Exercisable $ 0.596 $ 0.672
Weighted Average Remaining Contractual Terms (Years), Outstanding 9 months  
Weighted Average Remaining Contractual Terms (Years), Exercisable 9 months  

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Money Market Funds (Tables)
 6 Months Ended
Jun. 30, 2014
Investments, Debt and Equity Securities [Abstract]  
Fair Value Assets Measured on Recurring Basis

The following table presents money market funds at their level within the fair value hierarchy at June 30, 2014 and December 31, 2013.

 

    Total     Level 1     Level 2     Level 3  
                         
June 30, 2014:                        
Money market funds   $ 1,193,663     $ 1,193,663     $ —     $ —  
                                 
December 31, 2013:                                
Money market funds   $ 6,135     $ 6,135     $ —     $ —