VIVOS INC - Quarter Report: 2016 September (Form 10-Q)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

Form 10-Q

COMMISSION FILE NUMBER 000-53497

ADVANCED MEDICAL ISOTOPE CORPORATION

(Exact name of registrant as specified in its charter)

1021 N Kellogg Street,

Kennewick, WA 99336

(Address of principal executive offices, Zip Code)

(509) 736-4000

(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [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, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

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 November 14, 2016, there were 19,999,985 shares of the registrant’s Common Stock outstanding.

TABLE OF CONTENTS

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements.

Advanced Medical Isotope Corporation

Condensed Consolidated Balance Sheets

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

Advanced Medical Isotope Corporation

Condensed Consolidated Statements of Operations

(unaudited)

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

Advanced Medical Isotope Corporation

Condensed Consolidated Statements of Cash Flow

(Unaudited)

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

Advanced Medical Isotope Corporation

Notes to Condensed Consolidated Financial Statements

(Unaudited)

NOTE 1: BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES

The accompanying condensed consolidated financial statements of the Company have been prepared without audit, pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and disclosures required by accounting principles generally accepted in the United States have been condensed or omitted pursuant to such rules and regulations. These condensed consolidated financial statements reflect all adjustments that, in the opinion of management, are necessary to present fairly the results of operations of the Company for the period presented. The results of operations for the nine months ended September 30, 2016, are not necessarily indicative of the results that may be expected for any future period or the fiscal year ending December 31, 2016.

Use of Estimates

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

Fair Value of Financial Instruments

Fair Value of Financial Instruments, requires disclosure of the fair value information, whether or not recognized in the balance sheet, where it is practicable to estimate that value. As of September 30, 2016 and December 31, 2015, the balances reported for cash, prepaid expenses, accounts receivable, accounts payable, and accrued expenses, approximate the fair value because of their short maturities.

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. ASC Topic 820 established a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurements) and the lowest priority to unobservable inputs (level 3 measurements). These tiers include:

Level 1, defined as observable inputs such as quoted prices for identical instruments in active markets;

Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and

Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.

The Company measures certain financial instruments at fair value on a recurring basis. Assets and liabilities measured at fair value on a recurring basis were calculated using the Black-Scholes pricing model and are as follows at September 30, 2016:

Consolidation

Our financial statements consolidate all of our affiliates which consist of IsoPet Solutions, a wholly owned subsidiary which was established in May 2016. IsoPet Solutions will focus on bringing AMI’s yttrium-90 brachytherapy products to veterinary oncologists to treat animals such as dogs and cats suffering from tumor cancers. IsoPet Solutions is currently establishing the infrastructure necessary to provide product to veterinary clinics including regulatory clearances and compliance. As of September 30, 2016 there have been no revenues nor expenses incurred in the IsoPet Solutions subsidiary.

Recent Accounting Pronouncements

There are no recently issued accounting pronouncements that the Company believes are applicable or would have a material impact on the financial statements of the Company.

NOTE 2: GOING CONCERN

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. As shown in the accompanying financial statements, the Company has suffered recurring losses and used significant cash in support of its operating activities and the Company’s cash position is not sufficient to support the Company’s operations. Historically, the Company has relied upon outside investor funds to maintain the Company’s operations and develop the Company’s business. The Company anticipates it will continue to require funding from investors for working capital as well as business expansion during this fiscal year and it can provide no assurance that additional investor funds will be available on terms acceptable to us. These factors, among others, may indicate that the Company will be unable to continue as a going concern for a reasonable time. In addition, the Company’s ability to continue as a going concern must be considered in light of the problems, expenses and complications frequently encountered by entrance into established markets and the competitive environment in which it operates.

The Company anticipates a requirement of $1.5 million in funds over the next twelve months to maintain current operation activities. The Company may also require up to approximately $1.5 million to retire outstanding debt and past due payables, As of September 30, 2016 the Company has certain convertible promissory notes totaling approximately $260,000 that are currently due and payable (“Outstanding Notes”. These notes were satisfied during November 2016. See Note 10: Subsequent Events.

The Company requires funding of at least $1.5 million per year to maintain current operating activities. Over the next 12-24 months, the Company believes it will cost approximately $5 million to $10 million to fund: (1) the FDA approval process and initial deployment of the brachytherapy products and (2) initiate regulatory approval processes outside of the United States. The continued deployment of the brachytherapy products and a worldwide regulatory approval effort will require additional resources and personnel. The principal variables in the timing and amount of spending for the brachytherapy products in the next 12-24 months will be the FDA’s classification of the Company’s brachytherapy products as Class II or Class III devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies. Thereafter, the principal variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of those products and the products’ success in the U.S. and elsewhere. The Company intends to fund its activities through strategic transactions such as licensing and partnership agreements or additional capital raises.

As of September 30, 2016, the Company has $15 cash on hand. There are currently commitments to vendors for products and services purchased, accrued compensation expenses and the Company’s current lease commitments that in the absence of additional capital would result in a liquidation of the Company. The current level of cash is not enough to cover the fixed and variable obligations of the Company.

Assuming the Company is successful in the Company’s sales/development effort it believes that it will be able to raise additional funds through strategic agreements or the sale of the Company’s stock to either current or new stockholders. There is no guarantee that the Company will be able to raise additional funds or to do so at an advantageous price.

The financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company’s continuation as a going concern is dependent upon its ability to generate sufficient cash flow to meet its obligations on a timely basis and ultimately to attain profitability. The Company plans to seek additional funding to maintain its operations through debt and equity financing and to improve operating performance through a focus on strategic products and increased efficiencies in business processes and improvements to the cost structure. There is no assurance that the Company will be successful in its efforts to raise additional working capital or achieve profitable operations. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

NOTE 3: FIXED ASSETS

Fixed assets consist of the following at September 30, 2016 and December 31, 2015:

Depreciation expense for the above fixed assets for the three months ended September 30, 2016 and 2015, respectively was $738 and $936 and for the nine months ended September 30, 2016 and 2015, respectively, was $2,212 and $3,595.

NOTE 4: INTANGIBLE ASSETS

Intangible assets consist of the following at September 30, 2016 and December 31, 2015:

Amortization expense for the above intangible assets for the three months ended September 30, 2016 and 2015, respectively was $0 and $0 and for the nine months ended September 30, 2016 and 2015, respectively, was $0 and $1,339.

NOTE 5: RELATED PARTY TRANSACTIONS

Preferred Shares Issued to Officers

The Company received $35,000 from the CEO during the nine months ended September 30, 2016 in exchange for 8% Convertible Promissory Notes that were converted to 35,000 shares of Series A Preferred stock during the period ended September 30, 2016. Additionally, the Company issued a total of 2,800 shares of Series A Preferred stock as loan fees.

The Company issued 10,000 Series A Preferred shares to the CFO as a bonus during the nine months ended September 30, 2016.

Rent Expenses

The Company rents office space from a significant shareholder and director of the Company on a month to month basis with a monthly payment of $1,500.

During the nine months ended September 30, 2016 the Company reached a Settlement Agreement regarding a dispute related to a previous rental agreement where,starting after July 31, 2012, the Company was renting production space for $11,904 per month on a month to month basis. This settlement resulted in a payment of $438,830 for rent, interest, and costs. The Company allocated $40,000 of this settlement towards rent expense for previous years.

Rental expense for the three months and nine months ended September 30, 2016 and 2015 consisted of the following and is recorded in general and administrative expense:

NOTE 6: CONVERTIBLE NOTES PAYABLE

As of September 30, 2016 and December 31, 2015 the Company had the following convertible notes outstanding:

(1) Convertible Debt instruments accrue interest at an annual rate of 12% and a conversion price of $0.06. The Convertible Debt instruments also include Additional Investment Rights to enter into an additional convertible note with a corresponding amount of warrants equal to forty percent of the convertible note principal.

During the twelve months ending December 31, 2015 the holders of the Convertible Debt instruments received a repayment of $5,000 and $0 of the outstanding principal and accrued interest balances. During the nine months ending September 30, 2016 the Company reached a settlement agreement with two holders of the Convertible Debt instruments. One was for the $50,000 debt plus the $22,055 interest, plus the 500,000 warrants, and with another for the $20,000 debt plus the $11,652 interest, plus the 250,000 warrants.

During the twelve months ending December 31, 2015, total amortization was recorded in the amount of $0 and principal of $5,000 and accrued interest of $0 was repaid to the note holder. During the nine months ending September 30, 2016, total amortization was recorded in the amount of $0 and principal of $70,000 and accrued interest of $33,708 was repaid to the note holder. After repayments, conversions and amortization, principal totaled $95,000 and debt discount totaled $0 at September 30, 2016 and $165,000 and debt discount totaled $0 at December 31, 2015. During the nine months ending September 30, 2016 and the twelve months ending December 31, 2015 interest expense of $11,495 and $20,398, respectively, was recorded for the Convertible Debt Instruments. The $95,000 balance of the notes reached maturity during the year ended December 31, 2014 and are currently past due.

(2) The Company borrowed $50,000 January 2014, due January 2015, with interest at 8%. The holder of the note has the right, after the first one hundred eighty days of the note (July 27, 2014), to convert the note and accrued interest into common stock at a price per share equal to the lesser of $0.09 or 58% of the lowest trade price in the 10 trading days previous to the conversion. The Company recorded a debt discount of $50,000 related to the conversion feature and original issue discount, along with a derivative liability at inception (see Note 11: Derivative Liability). Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the twelve months ended December 31, 2015, total amortization was recorded in the amount of $0. After amortization, principal totaled $50,000, debt discount totaled $0. The Company accrued an additional $372 and $3,989 interest for the nine months ending September 30, 2016 and the twelve months ended December 31, 2015, respectively. During the nine months ending September 30, 2016 the Company reached a settlement agreement with the note holder for the $50,000 debt plus the $8,054 of accrued interest.

(3) The Company borrowed $55,500 January 2014, due October 2014, with interest at 10%. The holder of the note has the right, after the first one hundred eighty days of the note (July 23, 2014), to convert the note and accrued interest into common stock at a price per share equal to the lesser of $0.28 or 60% of the lowest trade price in the 25 trading days previous to the conversion. The note has an original issue discount of $5,500 which has been added to the principal balance of the note and is being recognized in interest expense over the life of the note. The Company recorded a debt discount of $55,000 related to the conversion feature and original issue discount, along with a derivative liability at inception (see Note 11: Derivative Liability). Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. The Company accrued an additional $823 and $1,096 interest for the nine months ending September 30, 2016 and twelve months ended December 31, 2015, respectively. The balance of the note reached maturity during the year ended December 31, 2014 and is currently past due.

(4) The Company borrowed $50,000 February 2014, due February 2015, with interest at 8%. The holder of the note has the right, after the first one hundred eighty days of the note (August 10, 2014), to convert the note and accrued interest into common stock at a price per share equal to the lesser of $0.07 or 58% of the lowest trade price in the 10 trading days previous to the conversion. The Company recorded a debt discount of $50,000 related to the conversion feature and original issue discount, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the twelve months ending December 31, 2015, total principal of $46,080 and accrued interest of $3,358 was converted into shares of common stock (see Note 9: Stockholders’ Equity), resulting in a decrease to the debt discount of $19,577. After conversions and amortization, principal totaled $0, debt discount totaled $0, and accumulated interest totaled $2,358 at September 30, 2016 and December 31, 2015.

(5) The Company borrowed $27,800 February 2014, due February 2015, with a one-time interest charge of 10%. The holder of the note has the right to convert the note and accrued interest into common stock at a price per share equal to the lesser of $0.195 or 60% of the lowest trade price in the 25 trading days previous to the conversion. The note has an original issue discount of $2,800 which has been added to the principal balance of the note and is being recognized in interest expense over the life of the note. Additionally, the holder of the note added a market price adjustment of $53,192 on the note due to delay in issuance of conversion shares. The Company increased the amount of the note by $53,192 and recorded a debt discount of $53,192. Interest expense for the amortization of the debt discounts is calculated on a straight-line basis over the nine month life of the note. During the twelve months ending December 31, 2015, total amortization was recorded in the amount of $25,877 and an additional $0 of interest was accrued. The balance of the note reached full maturity during the quarter ended June 30, 2015 and was settled September 30, 2015 for 5,000 shares of Series A Preferred Stock having a stated value of $5.00 per share and $20,000 cash payment due upon the consummation of a debt or equity financing resulting in gross proceeds to the Company of at least $500,000. During the nine months ended September 30, 2016, the Company reached a settlement agreement for the remaining $20,000 cash payment.

(6) The Company borrowed $50,000 March 2014, due March 2015, with interest at 10%. The holder of the note has the right, after the first one hundred eighty days of the note (September 18, 2014), to convert the note and accrued interest into common stock at a price per share equal to 60% of the lowest trade price in the 25 trading days previous to the conversion. The Company recorded a debt discount of $50,000 related to the conversion feature and original issue discount, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. After conversions and amortization, principal totaled $36,961 and debt discount totaled $0 for the periods ending September 30, 2016 and December 31, 2015. The Company accrued an additional $2,767 and $3,686 interest for the nine months ending September 30, 2016 and twelve months ended December 31, 2015, respectively. The balance of the note reached full maturity during the quarter ended June 30, 2015 and is currently past due.

(7) The Company borrowed $165,000 March 2014, due April 2015, with interest at 10%. The holder of the note has the right to convert the note and accrued interest into common stock at a price per share equal to the lesser of $1.00 or 65% of the average of the three lowest trading prices in the 20 trading days previous to the conversion. The note has an original issue discount of $15,000 which has been added to the principal balance of the note and is being recognized in interest expense over the life of the note. The Company recorded a debt discount of $165,000 related to the conversion feature and original issue discount, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the twelve months ending December 31, 2015, total principal of $23,211 was converted into shares of common stock, resulting in a decrease to the debt discount of $6,991. After conversions and amortization, principal totaled $61,301, debt discount totaled $0, and accumulated interest totaled $24,109 at December 31, 2015. The Company accrued an additional $348 for the nine months ending September 30, 2016. During the nine months ending September 30, 2016 the Company reached a settlement agreement with the note holder for the $61,301 debt plus the $24,457 of accrued interest.

(8) The Company borrowed $32,000 April 2014, due April 2015, with interest at 10%. The holder of the note has the right, after the first one hundred eighty days of the note (October 1, 2014), to convert the note and accrued interest into common stock at a price per share equal to 60% of the lowest trade price in the 25 trading days previous to the conversion. The Company recorded a debt discount of $32,000 related to the conversion feature and original issue discount, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. After conversions and amortization, principal totaled $22,042, debt discount totaled $0, and accumulated interest totaled $3,034 at December 31, 2015. The Company accrued an additional $1,650 and $2,198 interest for the nine months ending September 30, 2016 and twelve months ended December 31, 2015, respectively. The balance of the note reached full maturity during the quarter ended June 30, 2015 and is currently past due.

(9) The Company borrowed $46,080 April 2014, due April 2015, with interest at 10%. The holder of the note has the right, after the first one hundred eighty days of the note (October 11, 2014), to convert the note and accrued interest into common stock at a price per share equal to the lesser of $0.08 or 60% of the lowest trade price in the 25 trading days previous to the conversion. The Company has the right to prepay the note during the first ninety days following the date of the note. The Company recorded a debt discount of $46,080 related to the conversion feature and original issue discount, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. After conversions and amortization, principal totaled $5,419, debt discount totaled $0, and accumulated interest totaled $4,608 at September 30, 2016 and December 31, 2015. The balance of the note reached full maturity during the quarter ended June 30, 2015 and is currently past due.

(10) The Company borrowed $55,000 May 2014, due May 2015, with interest at 12%. The holder of the note has the right to convert the note and accrued interest into common stock at a price per share equal to the lesser of $0.03 or 55% of the lowest trade price in the 25 trading days previous to the conversion. The note has an original issue discount of $5,000 which has been added to the principal balance of the note and is being recognized in interest expense over the life of the note. The Company recorded a debt discount of $55,000 related to the conversion feature and original issue discount, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the twelve months ending December 31, 2015, total amortization was recorded in the amount of $24,315 and an additional $2,131 of interest was accrued. This note was settled May 1, 2015 for $100,000, $75,000 paid in cash and the remaining $25,000 as a 10% convertible debenture due May 31, 2016. The $25,000 convertible debenture is convertible at 55% of the lowest close for the last 270 days prior to the conversion notice or $0.03, but not less than $0.001. This settlement resulted in a reduction to notes payable of $46,090 and accrued interest payable of $5,516, an increase to note payable of $100,000 and a resulting $48,394 loss on settlement of debt. The Company accrued an additional $1,205 and $1,836 interest for the nine months ending September 30, 2016 and twelve months ended December 31, 2015, respectively. During the nine months ended September 30, 2016, the Company reached a settlement agreement with the note holder for the remaining $25,000 convertible debenture plus $3,041 of accrued interest.

(11) The Company borrowed $28,800 June 2014, due June 2015, with interest at 10%. The holder of the note has the right, after the first one hundred eighty days of the note (December 20, 2014), to convert the note and accrued interest into common stock at a price per share equal to the lesser of $0.08 or 60% of the lowest trade price in the 25 trading days previous to the conversion. The Company has the right to prepay the note during the first ninety days following the date of the note. The Company recorded a debt discount of $28,800 related to the conversion feature and original issue discount, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. After conversions and amortization, principal totaled $28,800, debt discount totaled $0, and accumulated interest totaled $2,880 at September 30, 2016 and December 31, 2015. The balance of the note reached full maturity during the quarter ended June 30, 2015 and is currently past due.

(12) The Company borrowed $40,000 June 2014, due June 2015, with interest at 10%. The holder of the note has the right, after the first one hundred eighty days of the note (December 23, 2014), to convert the note and accrued interest into common stock at a price per share equal to 60% of the lowest trade price in the 25 trading days previous to the conversion. The Company has the right to prepay the note and accrued interest during the first one hundred eighty days following the date of the note. During that time the amount of the prepayment is 145% of the outstanding amounts owed. The Company recorded a debt discount of $40,000 related to the conversion feature and original issue discount, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the twelve months ending December 31, 2015, total amortization was recorded in the amount of $19,398 and an additional $3,989 of interest was accrued. The Company accrued an additional $2,995 interest for the nine months ending September 30, 2016. The balance of the note reached full maturity during the quarter ended June 30, 2015 and is currently past due.

(13) The Company borrowed $40,000 June 2014, due June 2015, with interest at 10%. The holder of the note has the right, after the first one hundred eighty days of the note (December 23, 2014), to convert the note and accrued interest into common stock at a price per share equal to 60% of the lowest trade price in the 25 trading days previous to the conversion. The Company has the right to prepay the note and accrued interest during the first one hundred eighty days following the date of the note. During that time the amount of any repayment is 145% of the outstanding amounts owed. The Company recorded a debt discount of $40,000 related to the conversion feature and original issue discount, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the twelve months ending December 31, 2015, total amortization was recorded in the amount of $18,554 and an additional $3,858 of interest was accrued. The Company accrued an additional $2,896 interest for the nine months ending September 30, 2016. The balance of the note reached full maturity during the quarter ended June 30, 2015 and is currently past due.

(14) The Company borrowed $56,092 July 2014, due July 2015, with interest at 16%. The holder of the note has the right to convert the note and accrued interest into common stock at a price per share equal to the lesser of $1.00 or 65% of the average of the three lowest trading prices in the 20 trading days previous to the conversion. The note has an original issue discount of $5,000 which has been added to the principal balance of the note and is being recognized in interest expense over the life of the note. The Company recorded a debt discount of $51,092 related to the conversion feature and original issue discount, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the twelve months ending December 31, 2015, total amortization was recorded in the amount of $27,816 and an additional $8,950 of interest was accrued. The Company accrued an additional $319 interest for the nine months ending September 30, 2016 and reached a settlement agreement with the note holder for the $56,092 note balance plus $13,781 of accrued interest.

(15) The Company borrowed $37,500 July 2014, due July 2015, with interest at 12%. The holder of the note has the right to convert the note and accrued interest into common stock at a price per share equal to 50% of the lowest of the lowest trading price in the 15 trading days previous to the conversion. The Company recorded a debt discount of $37,500 related to the conversion feature and original issue discount, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the twelve months ending December 31, 2015, total amortization was recorded in the amount of $20,737 and an additional $4,430 of interest was accrued. The Company accrued an additional $2,901 interest for the nine months ending September 30. The balance of the note reached full maturity during the quarter ended September 30, 2015 and is currently past due.

(16) The Company borrowed $36,750 August 2014, due August 2015, with interest at 10%. The holder of the note has the right, after the first one hundred eighty days of the note (February 10, 2014), to convert the note and accrued interest into common stock at a price per share equal to 60% (representing a discount rate of 40%) of the lowest trading price for the Common Stock during the twenty five trading day period including the date of the Conversion Notice. The Company has the right to prepay the note and accrued interest during the first one hundred eighty days following the date of the note. During that time the amount of any prepayment is 145% of the outstanding amounts owed. The Company recorded a debt discount of $36,750 related to the conversion feature and original issue discount, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the twelve months ending December 31, 2015, total amortization was recorded in the amount of $22,755 and an additional $3,665 of interest was accrued. The Company accrued an additional $2,751 interest for the nine months ending September 30, 2016. The balance of the note reached full maturity during the quarter ended September 30, 2015 and is currently past due.

(17) The Company borrowed $33,500 August 2014, due February 2015, with interest at 4%. The Company may prepay the note for a net payment of $33,500 at any time prior to November 27, 2014. After November 27, 2014, the holder has the right to refuse any further payments and to convert this note when it matures, February 27, 2015. The holder of the note has the right to convert the note and accrued interest into common stock at a price per share equal to 60% (represents a 40% discount) of the average three lowest trade prices in the 20 trading days previous to the conversion. The note has an original issue discount of $6,500 which has been added to the principal balance of the note and is being recognized in interest expense over the life of the note. The Company recorded a debt discount of $32,807 related to the conversion feature and original issue discount, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the twelve months ending December 31, 2015, total amortization was recorded in the amount of $10,367. The balance of the note reached full maturity during the quarter ended March 31, 2015 and is currently past due. During the nine months ending September 30, 2016 the Company reached a settlement agreement with the note holder for the $33,500 debt.

(18) The Company borrowed $37,500 September 2014, due September 2015, with interest at 12%. The holder of the note has the right to convert the note and accrued interest into common stock at a price per share equal to 55% (represents a 45% discount) of the lowest trade prices in the 15 trading days previous to the conversion. The note has an original issue discount of $5,000 which has been added to the principal balance of the note and is being recognized in interest expense over the life of the note. The Company recorded a debt discount of $37,500 related to the conversion feature and original issue discount, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the twelve months ending December 31, 2015, total amortization was recorded in the amount of $25,927 and an additional $4,341 of interest was accrued. The Company accrued an additional $333 interest for the nine months ending September 30, 2016 and reached a settlement agreement with the note holder for the $36,263 note balance plus $5,908 of accrued interest.

(19) The Company borrowed $615,000 during the twelve months ending December 31, 2015, due September and October 2016, with interest at 8%. The holders of the notes have the right to convert the note and accrued interest into preferred stock at any time at a price per share of $1. The Company issued the note holders 48,200 Series A preferred shares as a loan origination fee. The Company recorded a debt discount of $615,000 related to the preferred shares issued as a loan origination fee, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve-month life of the note. During the twelve months ending December 31, 2015 total amortization in the amount of $615,000 and accrued interest in the amount of $18,264 was recorded towards these notes. As of December 31, 2015 these notes were converted into 615,000 Series A Convertible Preferred Shares.

(20) The Company borrowed $613,000 October through December 2015, due June 2016, with interest at 8%. The holders of the notes have the right to convert the note and accrued interest into preferred stock at any time at a price per share of $1. The Company issued the note holder 49,040 Series A preferred shares as a loan origination fee. The Company recorded a debt discount of $613,000 related to the conversion feature, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the life of the notes. During the nine months ending September 30, 2016 and the twelve months ending December 31, 2015, total amortization was recorded in the amount of $613,000 and $52,087 and an additional $13,676 and $2,350 of interest was accrued, respectively. As of September 30, 2016 these notes were converted into 613,000 Series A Convertible Preferred Shares.

(21) The Company borrowed $345,000 January through March 2016, due June 2016, with interest at 8%. The holders of the notes have the right to convert the note and accrued interest into preferred stock at any time at a price per share of $1. The Company issued the note holder 29,200 Series A preferred shares as a loan origination fee. The Company recorded a debt discount of $345,000 related to the conversion feature, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the life of the notes. During the nine months ending September 30, 2016 and the twelve months ending December 31, 2015, total amortization was recorded in the amount of $345,000 and $0 and an additional $1,541 and $0 of interest was accrued, respectively. As of September 30, 2016 these notes were converted into 345,000 Series A Convertible Preferred Shares.

As of September 30, 2016, certain convertible promissory notes described in this Note 6 not otherwise converted into common stock of the Company, totaling approximately $260,000, were due and payable (“Outstanding Notes”). Although no assurances can be given, management is currently negotiating with the holders of certain of the Outstanding Notes to restructure the principal and accrued interest currently due and payable. The principal amount due under certain of the Outstanding Notes may be reduced do to the offset of certain amounts resulting from the previous issuance of shares of common stock by the Company upon conversions of the Outstanding Notes, which were issued based on a conversion price below $0.001 per share. The issuances are voidable under the laws of the State of Delaware, the Company’s state of incorporation. The Company has issued a demand letter requiring the return to the Company of that number of shares of common stock issued upon conversion of Outstanding Notes equal to the value of the shares issued upon such conversion at a value below $0.001 per share (the “Excess Amount”). In the event the holder of such shares fails to return the shares, the Company intends to unilaterally and without further action by the parties reduce the principal amount of the Outstanding Notes by the Excess Amount. However the Company recorded an additional $910,867 in penalties and interest accrued on these notes to reflect the potential that the Company would be unable to prevail in reducing the amount of the notes for the shares of common stock delivered below $0.001 per share and the Company was unable to negotiate a settlement with these note holders.

NOTE 7: COMMON STOCK OPTIONS AND WARRANTS

Common Stock Options

The Company recognizes in the financial statements compensation related to all stock-based awards, including stock options and warrants, based on their estimated grant-date fair value. The Company has estimated expected forfeitures and is recognizing compensation expense only for those awards expected to vest. All compensation is recognized by the time the award vests.

The following schedule summarizes the changes in the Company’s stock options:

Common Stock Warrants

The following schedule summarizes the changes in the Company’s stock warrants:

NOTE 8: STOCKHOLDERS’ EQUITY

Common Stock Issued for Cash and the Exercise of Options and Warrants

As of December 31, 2015 there was an insufficient amount of the Company’s authorized common stock to satisfy the potential number of shares that would be required to satisfy the outstanding options, warrants and convertible debt into common stock. As a result the Company recorded a liability in the amount of $852,091, offset by $852,091 of equity for the period ending December 31, 2015. During the nine months ended September 30, 2016, although the effective date was October 2015, the Company filed a Certificate of Amendment to perform a 1:100 reverse stock split which eliminated the shortage of sufficient authorized common shares.

In April 2016, the Company issued 30,644 shares of common stock for cashless warrants exercise.

Preferred Stock Issued for Cash and the Exercise of Warrants

In March 2016, the Company issued 50,000 restricted shares of its Series A preferred stock in exchange for the cancellation of the warrants attached to the convertible notes received in July 2012.

In June 2016, the Company issued 250,000 restricted shares of its Series A preferred stock, pursuant to a warrant exercise.

In August 2016, the Company issued 12,854 restricted shares of its Series A preferred stock in exchange for the cancellation of the warrants attached to the convertible notes received in July 2015.

In August and September 2016, the Company issued 46,666 shares of Series A preferred stock in exchange for $70,000 cash.

Preferred Stock Issued for Loan Fees on Convertible Debt

During the nine months ending September 30, 2016 the Company issued 47,840 shares of its Series A preferred stock as loan fees on convertible promissory notes totaling $623,000.

During the nine months ending September 30, 2016 the Company issued 35,106 shares of its Series A preferred stock as loan fees on convertible promissory notes totaling $438,828 to a major shareholder and Director of the Company.

During the nine months ending September 30, 2016 the Company issued 2,800 shares of its Series A preferred stock as loan fees on convertible promissory notes totaling $35,000 to the CEO of the Company.

During the nine months ending September 30, 2016 the Company issued 30,000 shares of its Series A preferred stock as finder’s fees.

Preferred Stock Issued for Debt Converted

During the nine months ending September 30, 2016 the Company issued 654,791 Series A preferred stock in exchange for $1,636,779 of convertible debt received from a major shareholder and Director of the Company.

During the nine months ending September 30, 2016 the Company issued 1,223,000 Series A preferred stock in exchange for $1,296,000 of convertible debt.

During the nine months ending September 30, 2016 the Company issued 35,000 Series A preferred stock in exchange for $35,000 of convertible debt, to the CEO of the Company.

Preferred Stock Issued for Debt Settled

During the nine months ending September 30, 2016 the Company issued 185,600 Series A preferred stock in exchange for $184,762 of convertible debt, plus $50,711 of accrued interest.

Preferred Stock Issued for Services and Wages

During the nine months ending September 30, 2016 the Company issued 68,000 Series A preferred stock in exchange for $357,403 of services and $64,982 of wages.

During the nine months ending September 30, 2016 the Company issued 10,000 Series A preferred stock to the CFO of the Company.

NOTE 9: SUPPLEMENTAL CASH FLOW INFORMATION

During the nine months ending September 30, 2016 the Company issued 250,000 shares of its Series A preferred stock in exchange for $250 as a warrant exercise.

During the nine months ending September 30, 2016 the Company issued 30,000 shares of its Series A preferred stock as a finders fee at a value of $162,456.

During the nine months ending September 30, 2016 the Company issued 47,840 shares of its Series A preferred stock as loan fees on convertible promissory notes totaling $623,000.

During the nine months ending September 30, 2016 the Company issued 35,106 shares of its Series A preferred stock as loan fees on convertible promissory notes totaling $438,827 from a major shareholder and Director of the Company.

During the nine months ending September 30, 2016 the Company issued 2,800 shares of its Series A preferred stock as loan fees on convertible promissory notes totaling $35,000 from the CEO of the Company.

During the nine months ending September 30, 2016 the Company issued 185,600 Series A preferred stock in settlement for $184,762 of convertible debt, plus $50,711 of accrued interest.

During the nine months ending September 30, 2016 the Company issued 35,000 Series A preferred stock in exchange for $35,000 of convertible debt, to the CEO of the Company.

During the nine months ending September 30, 2016 the Company issued 1,203,000 Series A preferred stock in exchange for $1,256,000 of convertible debt, plus $13,962 of accrued interest, plus surrender of outstanding warrants.

During the nine months ending September 30, 2016 the Company issued 654,791 Series A preferred stock in exchange for $1,636,779 of convertible debt received from a major shareholder and Director of the Company.

NOTE 10: SUBSEQUENT EVENTS

The Company filed in September 2016 a Certificate of Amendment to perform a 1:100 reverse stock split with an effective date in October 2016. The Company has reflected to results of this reverse split in these financial statements for both the nine months ended September 30, 2016 and December 31, 2015.

During October 2016, the Company issued 150,000 restricted Series A Preferred Shares pursuant to a nine month advisory agreement for advise on an appropriate investor outreach program and introduction to potential investors and/or business partners and corporate advisory to facilitate a potential uplisting of the Company’s common stock to a qualified exchange.

During October 2016, the Company received $29,500 in shareholder loans.

During November 2016, the Company issued $812,500 in 10% convertible notes with $162,500 in original issue discounts and $6,000 in closing fees for net proceeds of $644,000. $377,332 was received at the initial closing with two tranches from four of the investors for an aggregate of $133,334 per tranche to be received over the next two months. In a subsequent closing in November 2016, the Company issued $310,000 in 10% convertible notes with $60,000 in original issue discounts for net proceeds of $250,000. The proceeds consisted of $161,203 of net cash, $77,533 previously funded shareholder advances, and accrued interest of $11,264 applied towards the purchase. In connection with the issuance of the 10% Convertible Notes, the Company issued 341,280 of Series A preferred stock as loan fees. A portion of these proceeds totaling $361,500 were used to pay off past due notes of $260,901, plus $48,398 accrued interest and eliminate $910,866 of penalties that had been accrued as of September 30, 2016. In addition to the cash payments paid to satisfy these past due notes, the Company issued 563,523 shares of common stock and 52,000 of Series A preferred stock as additional consideration to satisfy a portion of these obligations.

The Company has evaluated subsequent events pursuant to ASC Topic 855 and has determined that there are no additional subsequent events to disclose.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Except for statements of historical fact, certain information described in this Form 10-Q report contains “forward-looking statements” that involve substantial risks and uncertainties. You can identify these statements by forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “should,” “will,” “would” or similar words. The statements that contain these or similar words should be read carefully because these statements discuss the Company’s future expectations, including its expectations of its future results of operations or financial position, or state other “forward-looking” information. Advanced Medical Isotope Corporation believes that it is important to communicate its future expectations to its investors. However, there may be events in the future that the Company is not able to accurately predict or to control. Further, the Company urges you to be cautious of the forward-looking statements which are contained in this Form 10-Q report because they involve risks, uncertainties and other factors affecting its operations, market growth, service, products and licenses. The risk factors in the section captioned “Risk Factors” in Item 1A of the Company’s Form 10-Q, as well as other cautionary language in this Form 10-Q report, describe such risks, uncertainties and events that may cause the Company’s actual results and achievements, whether expressed or implied, to differ materially from the expectations the Company describes in its forward-looking statements. The occurrence of any of the events described as risk factors could have a material adverse effect on the Company’s business, results of operations and financial position.

General Statement of Business

Advanced Medical Isotope Corporation (the “Company,” “AMI” or “we”) was incorporated under the laws of Delaware on December 23, 1994 as Savage Mountain Sports Corporation (“SMSC”). On September 6, 2006, the Company changed its name to Advanced Medical Isotope Corporation. AMI has authorized capital of 2,000,000,000 shares of Common Stock, $0.001 par value per share and 20,000,000 shares of Preferred Stock, $0.001 par value per share (ADMD: OTCQB).

AMI is a late stage radiation oncology focused medical device company engaged in the development of yttrium-90 based brachytherapy devices for the treatment of non-resectable tumors. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. A prominent team of radiochemists, scientists and engineers, collaborating with strategic partners, including national laboratories, universities and private corporations, lead the Company’s development efforts. AMI has been recognized as a leader in the development of new isotope technologies by local, state and federal agencies. The Company’s overall vision is to globally empower physicians, medical researchers and patients by providing them with new isotope technologies that offer safe and effective treatments for cancer.

Since late 2013, AMI has focused its resources on developing a proposed line of yttrium-90 based brachytherapy products for the treatment of non-resectable tumors and on endeavoring to secure FDA clearance with respect to the initial proposed brachytherapy product. AMI’s proposed brachytherapy products incorporate patented technology developed for Battelle Memorial Institute (“Battelle”) at Pacific Northwest National Laboratory, a leading research institute for government and commercial customers. Battelle has granted AMI an exclusive license to patents covering these developments for manufacturing, processing and applications for medical isotopes (the “Battelle License”).

The Company’s lead product is the Y-90 RadioGel™ device. The Company is currently conducting additional bench and animal tests requested by the FDA to support a new de novo filing with the FDA that would request marketing clearance for the device as a Class II medical device in the United States. The Company is also exploring the pathway to regulatory clearance in other international markets.

In May of 2016, the Company established a wholly-owned subsidiary, IsoPet Solutions Corporation, to focus on the vibrant and expanding veterinary oncology market. IsoPet Solutions will focus on bringing AMI’s yttrium-90 brachytherapy products to veterinary oncologists to treat animals such as dogs and cats suffering from tumor cancers. IsoPet Solutions is currently establishing the infrastructure necessary to provide product to veterinary clinics including regulatory clearances and compliance.

Funded by a $250,000 Life Sciences grant, AMI is the commercial partner with Washington State University for treating cats with feline sarcoma. In October 2016 the first companion animal (a person’s pet) was injected with IsoPet. At last report, there no adverse effects, and the center of the tumor is successfully showing necrosis. A second cat is scheduled to be injected in December 2016.

Research and development of the Company’s brachytherapy product line has been funded with proceeds from the sale of equity and debt securities as well as a series of grants. On October 28, 2010, the Company received $1,215,000 net proceeds from a Department of Energy grant for the Proposed Congressionally Directed Project entitled “Research to Develop and Test an Advanced Resorbable Brachytherapy Seed Research for Controlled Delivery of Yttrium-90 Microspheres in Cancer Treatment.” On October 29, 2010, the Company received notification it had been awarded $244,479 grant funds from the Qualified Therapeutic Discovery Project Program for this same Brachytherapy Project. Additionally, on September 1, 2015, the Company received notification it had been awarded from Washington State University, $42,019 grant funds from the sub-award project entitled “Optimized Injectable Radiogels for High-dose Therapy of Non-Resectable Solid Tumors”.

The Company requires funding of approximately $1.5 million annually to maintain current operating activities. Over the next 12-24 months, the Company believes it will cost approximately $5 million to $10 million to fund: (1) the FDA approval process and initial deployment of the brachytherapy products and (2) initiate regulatory approval processes outside of the United States. The continued deployment of the brachytherapy products and a worldwide regulatory approval effort will require additional resources and personnel. The principal variables in the timing and amount of spending for the brachytherapy products in the next 12-24 months will be the FDA’s classification of the Company’s brachytherapy products as Class II or Class III devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies. Thereafter, the principal variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of those products and the products’ success in the U.S. and elsewhere. The Company intends to fund its activities through strategic transactions such as licensing and partnership agreements or additional capital raises.

Following receipt of required regulatory approvals and financing, in the United States, the Company intends to outsource material aspects of manufacturing, distribution, sales and marketing. Outside of the United States, the Company intends to pursue licensing arrangements and/or partnerships to facilitate its global commercialization strategy.

In the longer-term, subject to the Company receiving adequate funding, regulatory approval for brachytherapy products and thereafter being successful in commercializing brachytherapy products, the Company intends to consider resuming research efforts with respect to other products and technologies. The Company’s core goal is to develop and commercialize isotopes, businesses and technologies intended to help improve the diagnosis and treatment of cancer and other illnesses. Among those longer-term projects being considered by the Company are potential solutions for the impending severe shortages of Molybendum-99 and its derivative product Technetium-99m, the most widely used isotopes for diagnostic purposes.

Based on the Company’s financial history since inception, its auditor has expressed substantial doubt as to the Company’s ability to continue as a going concern. The Company has limited revenue, nominal cash, and has accumulated deficits since inception. If the Company cannot obtain sufficient additional capital, the Company will be required to delay the implementation of its business strategy and not be able to continue operations.

2016 Significant Events

On July 11, 2016, the Company announced that it has partnered with Versant Medical Physics and Radiation Safety company to provide dosimetry expertise to support development of the Company’s brachytherapy devices. Versant, a provider of comprehensive medical physics consulting services, will provide AMI with expert scientific and technical support on dosimetry, which is the calculation and assessment of the radiation dose received by the human body, for AMI’s medical devices. This formal relationship between AMI and Versant provides AMI access to experts in medical physics and dosimetry, including Versant physicist Dr. Darrell Fisher. The relationship with Versant provides a formal manner for Dr. Fisher to engage with AMI in a more meaningful and impactful way. Dr. Fisher has previously provided AMI with key input on product development including regulatory and commercialization issues and holds seven patents, including patents licensed by AMI for its brachytherapy products. Dr. Fisher is known internationally for his expertise in the dosimetry and effects of radioactive materials, including medically administered radiopharmaceuticals for diagnostic and therapeutic benefit. Dr. Fisher is a recent president of the Health Physics Society, an international organization of professionals engaged in the science and practice of radiation safety. He also serves on the Medical Internal Radiation Dose Committee of the Society of Nuclear Medicine and Molecular Imaging, which develops standard methods for radiopharmaceutical dosimetry. Dr. Fisher previously served on the U.S. Nuclear Regulatory Commission’s Advisory Committee on the Medical Uses of Isotopes. He recently completed a 35-year career at the Pacific Northwest National Laboratory (PNNL).

On July 19, 2016 the Company provided an update on its intellectual property including trademark expansion in international markets. AMI has a robust patent portfolio that includes exclusive rights under patents that cover medical isotope applications, processing and manufacturing. AMI is currently in negotiations with two organizations to enhance its patent portfolio related to its brachytherapy products. AMI continues to aggressively pursue trademark and patent protection for its brachytherapy products in anticipation of international product introduction. The Company has trademarked its leading cancer treatment under the RadioGel(TM) device trademark across the globe. The mark recently received registration in Hong Kong and Singapore. The mark has been allowed in the United States, and is registered under WIPO (World International Property Organization) in Australia, Japan, New Zealand, the Republic of Korea and the European Community (28 countries). It is also registered in the non-WIPO countries of Malaysia, Taiwan and Thailand and is pending in China and Indonesia. The RadioGel(TM) device trademark registration includes multiple product classes in many of these countries.

On October 6, 2016 the Company announced that the first household pet, a cat, has been treated for feline sarcoma with the Company’s pet version of the Y-90 RadioGel(TM) device. Following the initial treatment, the cat is scheduled to undergo seven follow-up appointments over a two year period.  The study outcome data will be reported to AMI periodically.  Funding for this study was provided by a grant from the Washington State Life Sciences Discovery Fund where AMI is the commercialization partner. 

On November 10, 2016 the Company announced the repayment of matured Convertible Notes and the resolution of all disputes and lawsuits related to these notes.

Products

Brachytherapy

Pursuant to the Battelle License, the Company has licensed certain exclusive rights to yttrium-90 (Y-90) polymer composite technology developed at Pacific Northwest National Laboratory, a leading research institute for government and commercial customers. The license agreement grants the Company the exclusive right to manufacture and market products using the yttrium-90 isotope carried by an injectable water-based biodegradable polymer. The use of yttrium 90 (Y-90) for the treatment of cancers is well established.

Subject to receipt of all required regulatory approvals from the FDA in the United States and analogous regulators outside of the United States, the Company plans to introduce a new Y-90-based brachytherapy product line for a range of applications for the delivery of a prescribed dose of radiation to a target site. If the Company receives FDA clearance for the Y-90 RadioGel™ device, subject to receipt of adequate financing, the Company will commence production, sales, and distribution of that product. Also, subject to receipt of adequate financing, the Company intends then to seek FDA clearance for the two additional products described below, each of which also incorporates the patented technologies licensed from Battelle. Even if the FDA grants clearance for the Y-90 RadioGel™ device there can be no assurance the FDA would also grant clearance for either or both of the foregoing products.

Y-90 RadioGel™ device - combines Y-90 particles with a polymer carrier that may be injected directly into the tumor.

Y-90 Fast-Resorbable Polymer Seeds - Y-90 contained within a polymer seed, as opposed to metal or glass. This product would be used in place of treating cancers with currently marketed titanium or glass seeds.

Y-90 Polymer Topical Paste – designed to be applied directly to tissue surfaces after surgical tumor removals (also referred to as “resections”) to treat residual tumor cells.

Based upon its studies and analyses, or general application of experience with current brachytherapy devices and yttrium-90, the Company believes that if it is able to obtain regulatory approval and adequate financing to commercialize our products, our brachytherapy products are likely to offer the following benefits, among others, for patients and medical professionals:

In June 2015, the FDA notified the Company that the de novo submitted on December 23, 2014 for its Y-90 RadioGel™ device pursuant to Section 513(f)(2) of the U.S. Food, Drug and Cosmetic Act (the “Act”) was not accepted. The Company had several formal and informal interactions with the FDA during the second half of 2015 to clarify the agency’s expectations for data and testing to be provided in a future filing. The Company has incorporated the feedback from the FDA into its continued and active product development and commercialization efforts, utilizing its partnership with IsoTherapeutics Group.

Competitors and Markets

There are established competitors in all of the markets in which the Company has products or currently plans to have products.

Brachytherapy

Brachytherapy is the use of radiation to destroy cancerous tumors by placing a radiation source inside or next to the treatment area. According to the 2014 MEDraysintell report, the global market for brachytherapy reached US$ 680 million in 2013 and is projected to reach $2.4 billion by 2030. It is estimated that the U.S. market represents approximately half of the global market. The Company believes there are significant opportunities in prostate, breast, liver, pancreatic, head and neck cancers. The 2014 U.S. estimated new cases of cancer according to the American Cancer Society are 233,000 prostate, 235,030 breast, 31,190 liver, and 46,420 pancreas.

There are a wide variety of cancer treatments approved and marketed in the U.S. and globally. General categories of treatment include surgery, chemotherapy, radiation therapy and immunotherapy. These products have a diverse set of success rates and side effects. The Company’s products fall into a particular type of radiation therapy called brachytherapy. There are a number of brachytherapy devices currently marketed in the U.S. and globally. The traditional iodine-125 (I-125) and palladium-103 (Pd-103) technologies for brachytherapy are well entrenched with powerful market players controlling the market. The industry-standard I-125-based therapy was developed by Oncura, which is a unit of General Electric Company (NYSE:GE) Additionally, C.R. Bard, a major industry player competes in the I-125 brachytherapy marketplace. These market competitors are also involved in the distribution of Pd-103 based products. Cs-131 brachytherapy products are sold by IsoRay (AMEX:ISR). Several Y-90 therapies have been FDA approved including SIR-Spheres by Sirtex (OTC:SXMDF), TheraSphere by Biocompatibles UK (OTC:BCTBF) and Zevalin by Spectrum Pharmaceuticals (NASDAQ:SPPI).

Veterinary Brachytherapy

There are about 150 million pet dogs and cats in the United States. Nearly half of dogs and one third of cats are diagnosed with cancer at some point in their lifetime. The Veterinary Oncology & Hermatology Center in Norwalk, CT reports that cancer is the number one natural cause of death in older cats and dogs, accounting for nearly 50 percent of pet deaths each year. The American Veterinary Medical Association reports that half of the dogs ten years or older will die because of cancer. The National Cancer Institute reports that about six million dogs are diagnosed with cancer each year, translating to more than 16,000 a day. The average cost of treating tumors in dogs using radiation is $5,000-7,000 according to petcarerx.com.

There are oncology treatments available currently in the U.S. and globally for the veterinary market represent a similar, but smaller set of products than is available for the human market.

Employees

As of September 30, 2016, the Company had four full-time employees. The Company utilizes eight to ten independent contractors to assist with its operations. The Company does not have a collective bargaining agreement with any of its employees, and believes its relations with its employees are good. The Company is not current on payroll and requires additional funding to make past and current payroll payments.

Raw Materials

The Company manufactures research quantities of brachytherapy products or components of these products. The Company obtains supplies, hardware, handling equipment and packaging from several different U.S. and foreign suppliers. Some of the products the Company manufactures or intend to manufacture require purchasing raw materials from a limited number of suppliers, many of which are international suppliers.

Customers

The Company anticipates that potential customers for our potential brachytherapy products likely would include those institutions and individuals that currently purchase brachytherapy products or other oncology treatment products.

Government Regulation

Significant areas of regulation and intervention include the following:

Environmental and Health Compliance.

The Company is committed to conducting its activities so that there is no or only minimal impact to the environment; there is no assurance, however, that the Company’s activities will not at times result in liability under environmental and health regulations.

The current ongoing continuing costs of compliance are immaterial. Future costs and expenses resulting from such liability may, however, materially negatively impact the Company’s operations and financial condition. Overall, environmental and health laws and regulations will continue to affect the Company’s businesses worldwide.

Medical Device Regulation

In the United States, radioactive medical devices are regulated by the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) under the Food and Drugs Act (CFR Title 21). Three categories of medical devices, Class I, Class II and Class III each of specific regulations that apply to the testing, approvals and marketing of such devices. In other countries there are also regulatory bodies that oversee the testing, approval and marketing of radiological devices.

Import/Export Regulation.

The Company is subject to significant regulatory oversight of the Company’s import and export operations due to the nature of its product offerings. Penalties for non-compliance can be significant, and violation can result in adverse publicity and financial risk for the Company.

Financial Accounting Standards.

The Company’s financial results can be impacted by new or modified financial accounting standards.

Other Regulations.

The Company’s operations are subject to rules and regulations administered by the U.S. Nuclear Regulatory Commission, Department of Energy, Food and Drug Administration, Department of Transportation, Department of Homeland Security, the Washington State Department of Health and other regulatory bodies. To the extent that these regulations are or become burdensome, business development could be adversely affected.

Available Information

The Company prepares and files annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and certain other information with the United States Securities and Exchange Commission (the “SEC”). Persons may read and copy any materials the Company files with the SEC at the SEC’s public reference room at 100 F Street, NE, Washington D.C. 20549, on official business days during the hours of 10 a.m. to 3 p.m. Eastern Time. Information may be obtained on the operation of the public reference room by calling the SEC at 1-800-SEC-0330. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at http://www.sec.gov. Moreover, the Company maintains a website at http://www.isotopeworld.com that contains important information about the Company, including biographies of key management personnel, as well as information about the Company’s business. This information is publicly available (i.e., not password protected) and is updated regularly. The content on any website referred to in this Form 10-Q report is not incorporated by reference into this Form 10-Q report, unless (and only to the extent) expressly so stated herein.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations. - continued

Results of Operations

Comparison of the Three Months Ended September 30, 2016 and 2015

The following table sets forth information from our statements of operations for the three months ended September 30, 2016 and 2015.

Revenue

Revenue was $0 for the three months ended September 30, 2016 and $12,054 for the three months ended September 30, 2015. The decrease was a result of a decrease in consulting revenues due to a reduction in consulting services provided. Consulting revenues consist of providing a company with assistance in strategic targetry services, and research into production of radiopharmaceuticals and the operations of radioisotope production facilities. No proprietary information belonging to our Company is shared during the process of this consulting.

Operating Expenses

Operating expenses for the three months ended September 30, 2016 and 2015 was $666,414 and $305,865, respectively. The increase in operating expenses from 2015 to 2016 can be attributed to the increase in Professional Fees expenses ($73,864 for the three months ended September 30, 2015 versus $265,497 for the three months ended September 30, 2016); an increase in Sales and Marketing expenses from 2015 to 2016 ($0 for the three months ended September 30, 2015 versus $65,995 for the three months ended September 30, 2016); an increase in stock options granted from 2015 to 2016 ($0 for the three months ended September 30, 2015 versus $27,427 for the three months ended September 30, 2016); and the increase in General and Administrative Expenses ($52,411 for the three months ended September 30, 2015 versus $146,257 for the three months ended September 30, 2016).

The increase in Professional Fees was due to the Company executing an agreement for $200,000 with an entity to provide advisory services. The increase in Marketing Expense was due to the Company executing an agreement for $20,000 per month with an entity to provide investor relation services. The increase in General and Administrative Expense was due to an increase in research expense ($102,691 for the three months ended September 30, 2016 versus $25,820 for the three months ended September 30, 2015). The increase in research expense was due to the additional research efforts brought on with the Company’s partnership with IsoTherapeutics Group plus the agreement with Versant Medical Physics and Radiation Safety to provide scientific and technical support to assist with new product development.

Operating expenses for the three months ended September 30, 2016 and 2015 consists of the following:

Non-Operating Income (Expense)

Non-operating income (expense) for the three months ended September 30, 2016 varied from the three months ended September 30, 2015 due to decrease in interest expense from $1,818,017 to $85,830 for the three months ended September 30, 2015 and 2016, respectively. This decrease was due to the Company’s reduction in overall debt as well as debt discounts. Loss on settlement of debt increased from a $144,290 gain to a $111,328 loss for the three months ended September 30, 2015 and 2016, respectively. Gain on derivative liability increased from $562,203 loss to $762,151 gain for the three months ended September 30, 2015 and 2016, respectively. This gain was as a result of the decrease in convertible debt.

Non-Operating income (expense) for the three months ended September 30, 2016 and 2015 consists of the following:

Net Loss

Our net loss for the three months ended September 30, 2016 and 2015 was $155,982 and $2,530,741 respectively.

Comparison of the Nine Months Ended September 30, 2016 and 2015

The following table sets forth information from our statements of operations for the nine months ended September 30, 2016 and 2015.

Revenue

Revenue was $8,108 for the nine months ended September 30, 2016, compared to $24,108 for the nine months ended September 30, 2015, a period over period decrease of $16,000. The decrease was a result of a loss of consulting revenue, currently our only source of revenue, during the first nine months of the fiscal year. Consulting revenue consists of providing clients with assistance in strategic targetry services, and research into production of radiopharmaceuticals and the operations of radioisotope production facilities. No proprietary information belonging to our Company is shared during the process of this consulting. Consulting services are currently our only source of revenue and is expected to generate less than $50,000 per year.

Operating Expense

Operating expenses for the nine months ended September 30, 2016 and 2015 was $4,575,904 and $977,763, respectively. The increase in operating expenses from 2015 to 2016 can be attributed to the increase in Professional Fees expenses ($245,164 for the nine months ended September 30, 2015 versus $1,968,084 for the nine months ended September 30, 2016); an increase in Sales and Marketing expenses from 2015 to 2016 ($0 for the nine months ended September 30, 2015 versus $213,539 for the nine months ended September 30, 2016); an increase in stock options granted from 2015 to 2016 ($28,500 for the nine months ended September 30, 2015 versus $612,343 for the nine months ended September 30, 2016); and the increase in General and Administrative Expenses ($160,254 for the nine months ended September 30, 2015 versus $1,287,649 for the nine months ended September 30, 2016).

Professional fees increased due to the exercise of previously issued warrants to purchase 250,000 shares of Series A Convertible Preferred Stock that were exercised in the quarter ended September 30, 2016. These warrants were issued pursuant to an advisory agreement related to the negotiation and implementation of comprehensive restructuring plan. The Company incurred a $1,069,353 non-cash expense related to the warrant exercise. In addition, the Company entered into an advisory agreement with a retainer of $200,000 and, which payment has been deferred and the future issuance of RSU’s to assist the Company in formulating and implementing its operating plan. In addition the Company incurred $216,608 expense from the issuance of stock and options to Directors, Officers, Employees, and Consultants. In addition, the Company’s legal fees increased from $63,007 to $235,285 for the nine months ended September 30, 2015 and 2016, respectively. This increase was due to the Company defending itself from lawsuits brought on by convertible notes in default and the dispute with BancLease and Washington Trust Bank regarding application of lease payments to the principal loan amount for the linear accelerator.

The increase in Marketing Expense was due to the Company executing an agreement for $20,000 per month with an entity to provide investor relation services as well as an overall increase in marketing and sales efforts.

The main contributors to the increase in General and Administrative Expenses was an increase in Loan Fees ($603,861 for the nine months ended September 30, 2016 versus $13,917 for the nine months ended September 30, 2015); Repairs and Maintenance ($226,655 for the nine months ended September 30, 2016 versus $5,979 for the nine months ended September 30, 2015); and an increase in Research Expense ($309,539 for the nine months ended September 30, 2016 versus $40,029 for the nine months ended September 30, 2015).

The increase in loan fees were due to the agreement to provide a percentage of loan proceeds as Series A Preferred shares. The increase in repairs and maintenance was due to the cost of moving the liner accelerator. The increase in research expense was due to the additional research efforts brought on with the Company’s partnership with IsoTherapeutics Group plus the agreement with Versant Medical Physics and Radiation Safety to provide scientific and technical support to assist with new product development.

Operating expenses for the nine months ended September 30, 2016 and 2015 consists of the following:

Non-Operating Income (Expense)

The Company had non-operating income of $6,566,783 during the nine months ended September 30, 2015, as compared to non-operating expense of $(5,576,972) during the nine months ended September 30, 2016. As shown below, this decrease in non-operating income is primarily due to a loss on derivative liability of $3,108,889 for the nine months ended September 30, 2016, as compared to a gain of $8,756,184 during the same period in 2015. The $3,108,889 loss on derivative liability is due to an increase in the Company’s stock price from January 2, 2015 ($0.0008) to September 30, 2016 ($0.0017) and an increase in preferred shares value which is also used to value derivatives. The Company’s stock price is used in the Black Scholes calculations to compute the derivative liability at the end of the quarter. Additionally, the Company experienced a decrease in non-operating income due to a loss on settlement of debt of $1,877,959 for the nine months ended September 30, 2016, as compared to a gain on settlement of debt of $281,966 for the nine months ended September 30, 2015. This increase in debt settlement costs was due to the successful negotiations in settling many of the debt that had been in default. The Company experienced a $54,561 loss on sale of stock for the nine months ended September 30, 2016. This loss on sale of stock derived from the sale of 46,666 Series A Preferred shares for $70,000. The value of the Company’s Series A Preferred stock, because it is not openly traded, was derived at utilizing Financial Accounting Standards Board Accounting Standards Codification topic 718 which determined a value of $5.4152 and $3.8294 we used each for 10,000 shares and 36,666 shares, respectively. The decrease in non-operating income was partially offset by a decrease in interest expense ($535,563 and $2,471,367 for the nine months ended September 30, 2016 and 2015, respectively). The decrease in interest expense was due to the Company’s reduction in overall debt as well as debt discounts.

Non-Operating income (expense) for the nine months ended September 30, 2016 and 2015 consists of the following:

Net Income (Loss)

Our net income (loss) for the nine months ended September 30, 2016 and 2015 was $(10,144,168) and $5,613,098, respectively, due primarily to the increase of operating expenses of $4,575,904 and $977,763 for the nine months ended September 30, 2016 compared to the nine months ended September 30, 2015, respectively; plus an increase of $12,143,755 in non-operating loss of $(5,576,972 for the nine months ended September 30, 2016, compared to a non-operating gain of $6,566,783 for the nine months ended September 30, 2015.

Liquidity and Capital Resources

At September 30, 2016, the Company had negative working capital of $4,126,519, as compared to $9,755,129 at September 30, 2015. During the nine months ended September 30, 2016 the Company experienced negative cash flow from operations of $1,645,825 and it expended $0 for investing activities while adding $1,466,808 of cash flows from financing activities. As of September 30, 2016, the Company had $0 commitments for capital expenditures.

Cash used in operating activities increased from $676,826 for the nine month period ending September 30, 2015 to $1,645,825 for the nine month period ending September 30, 2016. Cash used in operating activities was primarily a result of the Company’s net loss, partially offset by non-cash items, such as loss on derivative liability and amortization and depreciation, included in that net loss and preferred and common stock issued for services and other expenses. The Company had no cash used in investing activities for the nine month periods ended September 30, 2016 and 2015. Cash provided from financing activities increased from $684,019 for the nine month period ending September 30, 2015 to $1,466,808 for the nine month period ending September 30, 2016. The increase in cash provided from financing activities was primarily a result of increase in proceeds from convertible debt.

The Company has generated material operating losses since inception. The Company had a net loss of $10,144,168 for the nine months ended September 30, 2016, and net income of $5,613,098 for the nine months ended September 30, 2015. The Company expects to continue to experience net operating losses. Historically, the Company has relied upon investor funds to maintain its operations and develop the Company’s business. The Company anticipates raising additional capital within the next twelve months from investors for working capital as well as business expansion, although the Company can provide no assurance that additional investor funds will be available on terms acceptable to the Company. If the Company is unable to obtain additional financing to meet its working capital requirements, it may have to curtail its business.

The Company anticipates raising additional capital within the next twelve months from investors for working capital as well as business expansion, although the Company can provide no assurance that additional investor funds will be available on terms acceptable to the Company. If the Company is unable to obtain additional financing to meet its working capital requirements, it may have to cease operations.

The Company requires funding of at least $1.5 million per year to maintain current operating activities. Over the next 12-24 months, the Company believes it will cost approximately $5 million to $10 million to fund: (1) the FDA approval process and initial deployment of the brachytherapy products and (2) initiate regulatory approval processes outside of the United States. The continued deployment of the brachytherapy products and a worldwide regulatory approval effort will require additional resources and personnel. The principal variables in the timing and amount of spending for the brachytherapy products in the next 12-24 months will be the FDA’s classification of the Company’s brachytherapy products as Class II or Class III devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies. Thereafter, the principal variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of those products and the products’ success in the U.S. and elsewhere. The Company intends to fund its activities through strategic transactions such as licensing and partnership agreements or additional capital raises.

Although the Company is seeking the foregoing funding and has engaged in numerous discussions with potential finders, investment bankers and investors with respect to the initial portion thereof, the Company has not received firm commitments for the required funding. Based upon its discussions, the Company anticipates that if the Company is able to obtain the funding required to retire outstanding debt, pay past due payables and maintain its current operating activities that the terms thereof will be materially dilutive to existing shareholders.

The recent economic events, including the inherent instability and volatility in global capital markets, as well as the lack of liquidity in the capital markets, could impact its ability to obtain financing and its ability to execute its business plan. The Company believes healthcare institutions will continue to purchase the medical solutions that it distributes.

Legal Contingencies

There Company has an ongoing dispute with BancLease and Washington Trust Bank regarding application of lease payments to the principal loan amount for the linear accelerator, and the Company believes it has overpaid by approximately $300,000. On November 18, 2016 the Company is scheduled to appear in court on a motion for summary judgement to award the Company approximately $540,000, including attorney fees of approximately $40,000. At this time, the Company believes it will prevail in this matter, however there can be no assurance as to the outcome of this event.

In addition, there were disputes related to approximately $260,901 principle value of past due notes as of September 30, 2016. On November 10, 2016 the Company announced that it has successfully repaid these notes. The repayment of these notes resolved all disputes and lawsuits related to these notes.

Accounting Policies and Estimates

The preparation of financial statements and related disclosures in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the unaudited condensed consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. Actual results could differ from these estimates under different assumptions or conditions. During the period ended September 30, 2016, we believe there have been no significant changes to the items disclosed as significant accounting policies in management’s notes to the consolidated financial statements in our annual report on Form 10-K for the year ended December 31, 2015, filed on May 25, 2016 (Amendment was filed on May 26, 2016).

Off-Balance Sheet Arrangements

The Company does not have any off balance sheet arrangements that are reasonably likely to have a current or future effect on the Company’s financial condition, revenues, results of operations, liquidity or capital expenditures.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

This item is not applicable to us because we are a smaller reporting company as defined by Rule 12b-2 under the Securities Exchange Act of 1934.

Item 4. Controls and Procedures.

Disclosure Controls and Procedures

Based on an evaluation as of the date of the end of the period covered by this report, the Company’s Chief Executive Officer and Chief Financial Officer conducted an evaluation of the effectiveness of the design and operation of the Company’s disclosure controls and procedures, as required by Exchange Act Rule 13a-15. Based on that evaluation, the Company’s Chief Executive Officer and Chief Financial Officer concluded that, because of the disclosed material weaknesses in the Company’s internal control over financial reporting, the Company’s disclosure controls and procedures were ineffective as of the end of the period covered by this report to ensure that information required to be disclosed by the Company in the reports that the Company files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified by the SEC’s rules and forms.

Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in the Company’s reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in the Company’s reports filed under the Exchange Act is accumulated and communicated to management, including the Company’s Chief Executive Officer and the Company’s Chief Financial Officer, to allow timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting

There have been no changes in the Company’s internal control over financial reporting that occurred during the Company’s last fiscal quarter (the Company’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.