UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549
 

 
FORM 10-Q   
 

 
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the quarterly period ended September 30, 2016

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the transition period from _______ to _______

Commission File Number:   000-52601

BIO-AMD, INC.
(Exact name of registrant as specified in its charter)
 
Nevada
20-5242826
(State or other jurisdiction of incorporation) 
(I.R.S. Employer Identification No.)
 
Sci-Tech Daresbury, Keckwick Lane, Daresbury, WA4 4FS, UK
(Address of principal executive offices)
 
+ 44 (0) 8445 861910
(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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes   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.
 
Large accelerated filer
 
Accelerated filer
 
Non-accelerated filer
 
Smaller reporting company
 
 
 
 
(Do not check if a smaller
Reporting company)
 
 
 
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes     No  
 
There were 45,975,966 shares of the issuer’s common stock outstanding as of November 3, 2016.


BIO-AMD, INC.
 
FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2016
TABLE OF CONTENTS
 
 
 
PAGE
 
PART I - FINANCIAL INFORMATION
 
 
 
 
Item 1.
3
 
 
 
Item 2.
17
 
 
 
Item 3.
28
 
 
 
Item 4.
28
 
 
 
 
PART II - OTHER INFORMATION
 
 
 
 
Item 1.
29
 
 
 
Item 1A.
29
 
 
 
Item 2.
29
 
 
 
Item 3.
29
 
 
 
Item 4.
29
 
 
 
Item 5.
29
 
 
 
Item 6.
29
 
 
 
 
30
 
PART I – FINANCIAL INFORMATION
 
ITEM 1.  FINANCIAL STATEMENTS
 
 
PAGE
 
 
4
 
 
5
 
 
6
 
 
7
 
 
8


Bio-AMD, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
EXPRESSED IN US DOLLARS
 
 
 
September 30,
   
December 31,
 
 
 
2016
   
2015
 
 
 
(Unaudited)
       
ASSETS
           
 
           
Current Assets:
           
  Cash
 
$
122,952
   
$
437,400
 
  Amounts receivable
   
7,579
     
12,972
 
  Prepaid expenses
   
9,430
     
12,251
 
  Deferred charges
   
-
     
645,534
 
 
               
               Total Current Assets
   
139,961
     
1,108,157
 
 
               
Property and equipment, net
   
138
     
157
 
Patents (Note 3)
   
178,254
     
165,848
 
 
               
Total Assets
 
$
318,353
   
$
1,274,162
 
 
               
LIABILITIES AND EQUITY
               
 
               
Current Liabilities:
               
  Accounts payable
 
$
59,414
   
$
62,149
 
  Accrued liabilities
   
17,274
     
23,239
 
  Other liabilities
   
748
     
17,316
 
  Deferred revenue
   
-
     
950,402
 
 
               
Total Liabilities
   
77,436
     
1,053,106
 
 
               
Nature of Operations and Continuation of Business (note 1)
               
Commitment (Note 7)
               
Subsequent Event (Note 8) 
               
 
               
Stockholders' Equity:
               
 
               
  Preferred stock, 10,000,000 shares authorized, $0.001 par value, nil shares issued and
    outstanding
   
-
     
-
 
  Common stock, 500,000,000 shares authorized, $0.001 par value,
    45,975,966 shares issued and outstanding
   
45,976
     
45,976
 
  Additional Paid-in Capital
   
42,741,186
     
42,589,759
 
  Accumulated other comprehensive income
   
15,749
     
73,243
 
  Accumulated deficit
   
(41,429,171
)
   
(41,331,858
)
Total Bio-AMD, Inc. Stockholders' Equity
   
1,373,740
     
1,377,120
 
  Non-controlling interest
   
(1,132,823
)
   
(1,156,064
)
Total Stockholders' Equity
   
240,917
     
221,056
 
 
               
Total Liabilities and Stockholders' Equity
 
$
318,353
   
$
1,274,162
 
 
 (The accompanying notes are an integral part of these unaudited condensed consolidated financial statements)

Bio-AMD, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
EXPRESSED IN US DOLLARS
(Unaudited)
 
 
 
For the three months
   
For the nine months
 
 
 
ended September 30,
   
ended September 30,
 
 
 
2016
   
2015
   
2016
   
2015
 
 
 
$
     
$
     
$
     
$
   
Expenses:
                               
  General and administrative charges (Note 4)
   
68,099
     
160,781
     
325,693
     
739,277
 
 
                               
Total operating expense
   
68,099
     
160,781
     
325,693
     
739,277
 
 
                               
Net loss before other income
   
(68,099
)
   
(160,781
)
   
(325,693
)
   
(739,277
)
 
                               
Other income:
                               
   Gain on termination of research agreement (Note 5)
   
-
     
-
     
248,074
     
-
 
   Grant income
   
-
     
77,872
     
-
     
77,872
 
   Interest and other income
   
439
     
668
     
1,401
     
2,192
 
 
                               
Net income (loss)
   
(67,660
)
   
(82,241
)
   
(76,218
)
   
(659,213
)
 
                               
Net loss (income) attributable to the non-controlling interest
   
22,815
     
(16,682
)
   
(21,095
)
   
(9,382
)
 
                               
Net loss attributable to Bio-AMD, Inc. common shareholders
   
(44,845
)
   
(98,923
)
   
(97,313
)
   
(668,595
)
 
                               
Comprehensive Loss:
                               
Net income (loss)
   
(67,660
)
   
(82,241
)
   
(76,218
)
   
(659,213
)
Foreign currency translation adjustment, net of tax
   
(16,867
)
   
26,402
     
(33,921
)
   
(14,400
)
Total other comprehensive income (loss)
   
(84,527
)
   
(55,839
)
   
(110,139
)
   
(673,613
)
 
                               
Comprehensive (income)/loss attributable to the non-controlling interest
   
19,861
     
19,990
     
(44,668
)
   
(13,702
)
Comprehensive loss attributable to the Bio-AMD Inc. Common Shareholders
   
(64,666
)
   
(35,849
)
   
(154,807
)
   
(687,315
)
 
                               
Net loss per common share attributable to Bio-AMD, Inc. common shareholders - basic and diluted
 
$
(0.00
)
 
$
(0.00
)
 
$
(0.00
)
 
$
(0.01
)
 
                               
Weighted average number of common
shares outstanding - basic and diluted
   
45,975,966
     
45,975,966
     
45,975,966
     
45,266,425
 
 
(The accompanying notes are an integral part of these unaudited condensed consolidated financial statements)
 
Bio-AMD, INC.
CONDENSED CONSOLIDATED STATEMENT OF EQUITY
FOR THE NINE MONTH PERIOD ENDED SEPTEMBER 30, 2016
EXPRESSED IN US DOLLARS
(Unaudited)
 
 
                         
Accumulated
             
 
                         
Other
             
 
 
Common Stock
   
Additional
   
Accumulated
   
Comprehensive
   
Noncontrolling
   
Total
 
 
 
Shares
   
Amount
   
Paid-in Capital
   
Deficit
   
Income
   
Interest
   
Equity
 
Balance at December 31, 2014
   
44,525,966
     
44,526
     
42,329,451
     
(40,504,433
)
   
102,589
     
(1,138,732
)
   
833,401
 
 
                                                       
Issuance of shares for prepaid services
   
300,000
     
300
     
53,700
     
-
     
-
     
-
     
54,000
 
 
                                                       
Issuance of shares for services
   
1,150,000
     
1,150
     
182,850
     
-
     
-
     
-
     
184,000
 
 
                                                       
Comprehensive loss
   
-
     
-
     
-
     
-
     
(29,346
)
   
9,974
     
(19,372
)
 
                                                       
Subsidiary preferred dividend
   
-
     
-
     
23,758
     
-
     
-
     
(23,758
)
   
-
 
 
                                                       
Net loss
   
-
     
-
     
-
     
(827,425
)
   
-
     
(3,548
)
   
(830,973
)
Balance at December 31, 2015
   
45,975,966
     
45,976
     
42,589,759
     
(41,331,858
)
   
73,243
     
(1,156,064
)
   
221,056
 
 
                                                       
Comprehensive loss
   
-
     
-
     
-
     
-
     
(57,494
)
   
23,573
     
(33,921
)
 
                                                       
Investment in subsidiary
                   
130,000
                             
130,000
 
                                                         
Subsidiary preferred dividend
   
-
     
-
     
8,914
     
-
     
-
     
(8,914
)
   
-,
 
 
                                                       
Change in ownership interest of subsidiary
   
-
     
-
     
12,513
     
-
     
-
     
(12,513
)
   
-
 
 
                                                       
Net loss
   
-
     
-
     
-
     
(97,313
)
   
-
     
21,095
     
(76,218
)
Balance at September 30, 2016
   
45,975,966
     
45,976
     
42,741,186
     
(41,429,171
)
   
15,749
     
(1,132,823
)
   
240,917
 
 

(The accompanying notes are an integral part of these unaudited condensed consolidated financial statements)
Bio-AMD, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
EXPRESSED IN US DOLLARS
(Unaudited)
 
 
 
For the nine months ended September 30,
 
 
 
2016
   
2015
 
Cash flows from operating activities:
           
Net loss
 
$
(76,218
)
 
$
(659,213
)
 
               
Adjustments to reconcile net loss to net cash
used in operating activities:
               
        Amortization of prepaid stock based fees
   
-
     
39,000
 
       Gain on termination of research agreement
   
(248,074
)
       
        Stock based consulting fees
           
184,000
 
         Changes in operating assets and liabilities:
               
              Prepaid expenses
   
2,821
     
(11,456
)
              Amounts receivable
   
5,393
     
10,523
 
              Deferred charges
   
(46,879
)
   
(534,295
)
              Security deposit and other assets
   
-
     
(24,443
)
              Accounts payable and accrued expenses
   
(8,700
)
   
67,689
 
              Other liabilities
   
(16,568
)
   
9,717
 
              Deferred revenue
   
-
     
983,790
 
                Total Adjustments
   
(312,007
)
   
724,525
 
 
               
                Net cash used in operating activities
   
(388,225
)
   
65,312
 
 
               
Cash flows used in investing activities:
               
  Patent expenditures
   
(34,890
)
   
-
 
Net cash used in investing activities
   
(34,890
)
   
-
 
 
               
Cash flows from financing activities:
               
  Proceeds from investment in MIDS Medical
   
130,000
     
-
 
Net cash provided by financing activities
   
130,000
     
-
 
 
               
 
               
Effects of exchange rate changes on cash
   
(21,333
)
   
(16,948
)
 
               
Net (decrease) increase in cash
   
(314,448
)
   
48,364
 
 
               
Cash, beginning of period
   
437,400
     
717,144
 
 
               
Cash, end of period
 
$
122,952
   
$
765,508
 
 
               
Supplementary disclosure of cash flow information:
               
Cash paid during the period for:
               
Interest
 
$
-
   
$
-
 
Income tax
 
$
-
   
$
-
 
 
               
Supplemental schedule of non-cash investing and financing activities:
 
$
-
   
$
-
 
Common stock issued for prepaid services
 
$
-
   
$
54,000
 

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

Bio-AMD, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
September 30, 2016
(Expressed in US dollars)
 
Note 1 – Nature of Operations and Continuance of Business
 
General
 
The accompanying unaudited condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Certain information and note disclosures normally included in annual consolidated financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to those rules and regulations, although the Company believes that the disclosures made are adequate to make the information not misleading.
 
In the opinion of management, the unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the consolidated financial position as of September 30, 2016 and the results of operations and cash flows for the three and nine month periods ended September 30, 2016 and 2015. The financial data and other information disclosed in the notes to the interim condensed consolidated financial statements related to these periods are unaudited. The results for the three and nine month periods ended September 30, 2016 are not necessarily indicative of the results to be expected for any subsequent quarter or the entire year ending December 31, 2016.
 
These unaudited condensed consolidated financial statements should be read in conjunction with our audited consolidated financial statements and the notes thereto for the year ended December 31, 2015, included in the Company’s annual report on Form 10-K filed with the SEC on March 30, 2016.
 
Nature of Operations
 
Bio-AMD, Inc. (“Bio-AMD” the “Company”, “we”, “us”, “our”) (formerly known as Flex Fuels Energy, Inc. and Malibu Minerals, Inc.) was incorporated in the State of Nevada on March 10, 2006 to engage in the business of exploration and discovery of gold, minerals, mineral deposits and reserves.
 
On April 15, 2011, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) pursuant to which we merged with our newly formed, wholly owned subsidiary, Bio-AMD, Inc., a Nevada corporation (“Merger Sub” and such merger transaction, the “Merger”). Upon the consummation of the Merger, the separate existence of Merger Sub ceased and shareholders of the Company became shareholders of the surviving company named Bio-AMD, Inc. As permitted by Chapter 92A.180 of Nevada Revised Statutes, the sole purpose of the Merger was to effect a change of our name to Bio-AMD, Inc. to better reflect our core business area. Upon the filing of Articles of Merger (the “Articles of Merger”) with the Secretary of State of Nevada on April 15, 2011 to effect the Merger, our Articles of Incorporation were deemed amended to reflect the change in our corporate name.  We are quoted on OTC Markets and the OTC Bulletin Board under the symbol “BIAD”.
 
During the fourth quarter of our 2006 fiscal year, for the purpose of diversifying our business, acquiring capital, gaining greater access to the capital markets and with the assistance of newly acquired capital, we entered into an Agreement with Flex Fuels Energy Limited (“FFE Ltd”) and the stockholders of FFE Ltd by which FFE Ltd became our wholly-owned subsidiary effective on May 29, 2007. FFE Ltd engaged in the development of the business of manufacturing and distributing Oil Seed Rape (“OSR”) products.
 
Effective September 5, 2009, after having carefully evaluated all options, we abandoned our proposed oil seed business, as we no longer considered the business to be economically viable on either a go alone or partnered basis.  The proposed project initiated by prior management involved building an oil seed crushing plant at Cardiff, Wales was compromised by delays, sub-optional design and substantial legal costs.  We were unable to raise the necessary financing, to locate a project partner, or to divest our interest in the project for value.  Accordingly, we determined that our best course of action was to preserve value by winding down the oil seed operations of FFE Ltd.
From our inception through the date of these unaudited condensed consolidated financial statements, we have not generated any revenues and have incurred significant expenses. The Company intends to fund its development of the currency risk technology, diagnostic technology and on-going operations through equity and/or debt financing arrangements.  However, there can be no assurance that these arrangements will be sufficient to fund its ongoing capital expenditures, working capital, and other cash requirements. Consequently, our operations are subject to all the risks and uncertainties inherent in the establishment of a new business enterprise.
 
WOCU Limited Acquisition

On May 1, 2009, we entered into an Investment Agreement (the “Investment Agreement”) with WDX Organisation Limited, a corporation incorporated under the laws of England and Wales, and the founding shareholders of WDX Organisation Limited (the “Founders”), the owners of all of the issued and outstanding shares of WDX Organisation Limited.  On the same date, we entered into a related Loan Agreement (the “Loan Agreement”) and a related Option and Funding Agreement (the “Funding Agreement”) with WDX Organisation Limited.  The Investment Agreement, Loan Agreement and Funding Agreement are hereinafter collectively referred to as the “Agreements”. Pursuant to the Agreements, we acquired 51% ownership of WDX Organisation Limited. WDX Organisation Limited changed its name to WOCU Limited (“WL”) effective January 29, 2013.

WL is the developer of the WOCU technology, an algorithm and system of providing reference data for its WOCU global currency unit, designed to mitigate currency risk. On August 14, 2009, we provided a further £150,000 (approximately $247,800) to WL by way of a loan and have exercised certain call options. On November 20, 2009, we loaned an additional £150,000 (approximately $249,840) to WL and increased our equity position in WL. WL has been working to develop contracts with a variety of banks, currency exchange networks, data providers, and derivative exchanges in an effort to commercialize its WOCU technology through licensing agreements. 

On March 8, 2010, we loaned an additional £150,000 (approximately $224,055) to WL and executed certain call options to further increase our equity position in WL. The loans were the result of our ongoing investment in WL as contemplated by our May 1, 2009 Investment Agreement with WL.
 
Altogether, these transactions resulted in a total loan of £600,000 (approximately $904,000) to WL and the ownership of 93% of WL by the Company on March 8, 2010.
 
On July 23, 2010, we entered into a Subscription Agreement with WL and the founders of WL under which we purchased 500,000 preference shares of WL (the “Preference Shares”) at a price of one British Pound per share (approximately $750,000).   The Preference Shares earn in priority to any other class of stock of WL, a cumulative dividend equal to 5% of the subscription price of such Preference Shares per annum. These Preference Shares carry a preference over all other classes of WL stock in the event of a sale, liquidation or listing of WL. Upon liquidation, sale or listing and after repayment of the outstanding loans made by us to WL, other liabilities of WL and related transaction costs, the holder of the Preference Shares is entitled to a payment equal to three times the subscription price (the “Preference Shares Payment”) paid for such Preference Shares.  The Preference Shares are redeemable upon a sale, listing or winding down of WL.
 
The Subscription Agreement also provided for WL to allot up to an aggregate of 16,900 C Ordinary Shares of WL to employees, directors and consultants of WL to secure their continued service to WL and incentivize them in the performance thereof.  An aggregate of 14,061 C Ordinary Shares were issued, for nominal consideration, to three employees and Robert Galvin, our former Chief Financial Officer on July 23, 2010. The issuance of the 14,061 C Ordinary Shares reduced our ownership in WL from 93% to 77.54%.

Effective June 30, 2011, WL agreed with all three of its employees to terminate existing employment agreements so as to reduce the monthly cash outflows. As a result of the termination of employment contracts, and in accordance with the WL Articles of Association, terminated employees gave up 9,243 C Ordinary Shares. This increased our ownership in WL to 87.13%.

During November 2011, we loaned an additional £50,000 (approximately $77,000) to WL as a short-term unsecured intercompany loan. On July 12, 2012, it was agreed that this loan would be settled through the issuance of 5,000,000 common shares, increasing our ownership in WL to 99.81%.
Since January 2013, the Company has provided further advances totaling £196,000 (approximately $260,000) into WL to fund its operations based on the prospective pipeline of opportunities that have been generated.

As at September 30, 2016, there were no commercial agreements in place, and no revenues had been generated by WL. Given the Company's limited resources, it is unlikely that the Company can support WL operations going forward, as a contractor to WL vital to its technical operation has indicated it is not willing to continue to provide its services at the current much reduced rate of payment and accordingly further investment will be required to support WL. The Company's default option is to shut down WL. The Company is considering any option that might preserve any value in WL and is considering an offer from the contractor and our CEO, Mr Thomas Barr, to purchase the Company's shares in WL in exchange for nominal consideration and a future payment contingent on the future success of WL, if any.

Bio-AMD Holdings Limited Acquisition

On February 25, 2010, we entered into a Subscription and Shareholders Agreement with Bio-AMD Holdings Limited (“Bio-AMD Holdings”), a United Kingdom company, and the managers of Bio-AMD Holdings, under which we acquired a 63% interest in Bio-AMD Holdings for £865,000 British Pounds (approximately $1,335,000) through the purchase of preferred shares.  The preferred shares accrue dividends at the rate of 5% per year and provide for a preference in liquidation equal to £865,000, plus accrued unpaid dividends (the preference on a sale is £850,000, plus accrued and unpaid dividends). Bio-AMD Holdings is a development stage company, formed in February 2010, which, through its operating subsidiary, Bio Alternative Medical Devices Ltd. (“Bio-Medical”), principally operates in the Medical Point of Care (“POC”) diagnostic space. Where context requires, reference to Bio-AMD Holdings also includes reference to Bio-Medical. Bio-AMD Holdings owns a portfolio of patent applications on technologies, which it expects to enable it to develop highly accurate, low cost, hand held electronic diagnostic devices capable of reading certain third party assays. Since 2010 Bio-AMD Holdings has been developing its technology into three initial product types (1) a digital strip reader targeted initially into the “over the counter” female well-being market (including digital pregnancy, ovulation and fertility testing, (2) a blood coagulation device and (3) early stage development work into a POC immunoassay detection system based on magnetic nanoparticle manipulation.  In addition, Bio-AMD Holdings is working to develop various commercial relationships with manufacturers, bio-chemistry companies and sales distributions partners to enable commercialization of its products through licensing agreements.
 
Since January 2014, the Company has provided additional working capital by way of cash injections via intercompany loans amounting to £100,000 (approximately $132,000) to Bio-AMD Holdings to further fund operations. These loans are secured against the assets of Bio-AMD Holdings and its wholly owned operating subsidiary, Bio-Medical.

Restructuring of Bio-AMD Holdings and Bio-Medical operations

On June 1, 2016, the intellectual property relating to the Company’s DSR, COAG and MIDS projects (the “IP”) and depreciated physical equipment assets (together the IP, the “Assets”), formerly under the control of Bio-AMD Holdings and Bio-Medical, were brought into the full control of Bio-AMD, Inc. under loan security agreements put in place by the Company during 2015.
 
On June 17, 2016, the Company entered into a Subscription and Shareholders’ Agreement with Bio-AMD UK Holdings Limited (“UKH”), a United Kingdom company, and the managers of UKH, under which we acquired a 70% interest in UKH in exchange for the Assets.
 
UKH is a development stage company, formed in May 2009 by the Company’s two principal and key scientists formerly contracted to Holdings, Dr. Nasser Djennati and Dr. Andrew Mitchell. UKH was formerly dormant and has never traded. Immediately prior to the transaction UKH formed a new subsidiary, MIDS Medical Limited (“MML”) as a dedicated vehicle to develop our MIDS universal immunoassay detection technology in a joint venture, further described below. UKH has taken over most of the operations of Holdings and Bio-Medical.
 
The 30% of UKH not owned by the Company is owned by Dr. Nasser Djennati (15%) and Dr. Andrew Mitchell (15%), whose experience and qualifications were reported on Form 8K filed on March 3, 2010. The board of directors of UKH consists of, and the board of MML includes, Drs. Djennati and Mitchell, and Mr Barr, the Company’s CEO.
 
The effect of the restructuring was to beneficially increase the Company’s interest in its UK medical operations from 63% to 70%, to simplify and gain better voting control of its UK subsidiaries, and to eliminate two employee profit share arrangements.
As a result of the incremental increase in the ownership of the Assets, the Company recorded a charge to Additional Paid-in Capital and the Non-controlling Interest of $12,513. The amount represents the Company’s additional interest in the net book value of the group of Assets determined by voting control.

MIDS Medical Limited Operations

On June 20, 2016, the Company and its UKH and MML subsidiaries entered into a joint venture by way of a Subscription and Shareholders’ Agreement (“Agreement”) with a third party medical detection device developer (“Partner”) a Nevada corporation, under which the Partner, in exchange for its participation and funding to support MML during a Phase 1 development, owns a 40% interest in MML as of July 1, 2016, The Partner also prospectively agreed to fund a Phase 2 development of our MIDS universal immunoassay detection technology within the MML vehicle. MML will have the right to use the MIDS Intellectual Property (“MIDS IP”) under license during the development and the MIDS IP will be transferred to MML in the event that MML concludes a commercial deal for MIDS with a third party.

The Agreement provided for a series of payments ("Phase 1 Payments") in an aggregate amount of £450,500 (approximately $650,000 based on the rate of exchange prevailing at the time of the agreement). The Partner made a Phase 1 Payment to MML, of $130,000 (the "First Payment"), which was received on August 2, 2016 and was converted to £92,857. Subsequent Phase 1 Payments were expected to be received as follows; (a) on or before September 20, 2016, a payment £106,093, (b) on or before November 20, 2016, a payment of £100,640; (c) on or before January 20, 2017, a payment of £100,640; and (d) on or before March 20, 2017, a payment of £50,320.

On September 29, 2016, the Agreement was amended to provide for the Phase 1 payments to be made in US dollars to an amended timetable, with all other provisions of the Agreement remaining in force: The Partner made a Phase 1 Payment to MML of $130,000 (the "First Payment"), received on August 2, 2016 and further payments of $30,000 and $110,000 were received on October 28, 2016 and November 2, 2016 respectively. Subsequent Phase 1 Payments are expected to be received as follows; (a) on or before November 30, 2016, a payment of $152,500; (b) on or before January 31, 2017, a payment of $152,500; and (c) on or before March 31, 2017, a payment of $75,000.

On October 11, 2016, the Partner appointed its CEO to the board of MML.

The Agreement also provides for a contingency funding (“Contingency”) to be made available by the Partner after March 31, 2017 in an aggregate amount of up to £45,000 (approximately $64,000) to be paid by the Partner within 20 days of receiving a written notice from  MML.

The parties to the Agreement envisage a second phase of development (“Phase 2”) to follow Phase 1. This is expected to be broadly over a similar timeframe and at a similar cost. MML may independently obtain funding for Phase 2 at MML’s option, or invite the Partner to fund.

The Agreement contains various provisions to govern the funding obligations of the Partner: if any Phase 1 Payment is not made within 14 days of it falling due (“Default”), the Partner’s shareholding in MML may be reduced to zero; if no Contingency is drawn during Phase 1, UKH will be awarded an enduring 2.5% profit after tax right in MML (“Override”) which will increase to a 15% Override if the Partner declines to fund Phase 2; if the Partner declines to fund Phase 2 and any Contingency has been drawn, UKH will be awarded a 15% Override decreased by 0.5% for each £7,500 tranche of Contingency drawn down during Phase 1. Any Override will convert pro rata into ordinary shares in the event of a sale of MML.

Provided that each Phase 1 Payment is made within 14 days of falling due, the Partner also has additional control rights over MML, including representation on the MML board of directors, rights over the appointment and employment of senior management persons, indebtedness, major transactions, budget approval rights, accounting practices and general operational management supervisory rights.
 
As a condition of the Agreement, MML has entered into Supply of Services Agreements under which it receives the services of Drs. Djennati and Mitchell, being key personnel related to the MIDS development.

The Company has agreed, pursuant to a letter agreement (the “Warrant Agreement”), to prospectively issue 3,000,000 five year warrants in the Company exercisable at $0.10, to certain third parties (or their nominees) who have introduced the Partner to the Company (“Introducer Warrants”). The Warrant Agreement provides for the Introducer Warrants to be issued at the discretion of the Company at any time up to MML receiving the final Phase 1 Payment, and may not be exercised prior to June 15, 2017. In the event the Phase 1 Payments are not made in full, the Company will have the right to cancel the issuance of the Introducer Warrants, or to negotiate revised terms, at the Company’s sole option. No other fees have been paid in regard to the Agreement. As at September 30, 2016, the Company has not issued any Introducer Warrants.
Going Concern

The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.  The Company has not commenced its planned principal operations. As shown in the accompanying unaudited condensed consolidated financial statements, the Company has not generated any revenue and has incurred recurring losses through September 30, 2016.  Additionally, the Company has recurring negative cash flows from operations and has an accumulated deficit of $41,429,171 as at September 30, 2016.  These factors raise substantial doubt about the Company’s ability to continue as a going concern.
  
The Company’s ability to continue its existence is dependent upon commencing its planned operations, management’s ability to develop and achieve profitable operations and/or upon obtaining additional financing to carry out its planned business. The Company intends to fund the development of its diagnostic technology and on-going operations through equity and debt financing arrangements.  However, there can be no assurance that these arrangements will be sufficient to fund its ongoing capital expenditures, working capital, and other cash requirements.  The outcome of these matters cannot be predicted at this time.

There can be no assurance that any additional financings will be available to the Company on satisfactory terms and conditions, if at all.  In the event we are unable to continue as a going concern, we may elect or be required to seek protection from our creditors by filing a voluntary petition in bankruptcy or may be subject to an involuntary petition in bankruptcy. To date, management has not considered this alternative.
 
The accompanying unaudited condensed consolidated financial statements do not include any adjustments related to the recoverability or classification of asset-carrying amounts or the amounts and classification of liabilities that may result should the Company be unable to continue as a going concern. 
 
Note 2 – Summary of Significant Accounting Policies
 
Use of estimates

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

The unaudited condensed consolidated financial statements include the accounts of Bio-AMD, Inc., WOCU Limited (a 99.81% owned subsidiary as of September 30, 2016), Bio-AMD Holdings Limited (a 63% owned subsidiary as of September 30, 2016), along with Bio-AMD Holdings Limited’s wholly owned subsidiary Bio-Medical, and Bio-AMD UK Holdings Limited (“UKH”) (a 70% owned subsidiary effective September 30, 2016), along with its then wholly owned subsidiary, MIDS Medical Limited. All significant intercompany transactions and balances have been eliminated in consolidation.  
 
The third party ownerships of 0.19% of WL, 37% of Bio-AMD Holdings, and 30% of UKH are recorded as non-controlling interests in the unaudited condensed consolidated financial statements. 

Patents

Patents are stated at cost less accumulated amortization and are comprised of patent applications on technologies which the Company expects to enable it to develop highly accurate, low cost, hand held electronic diagnostic devices capable of reading third party assays. The patents are amortized straight-line over the estimated useful life but not to exceed 17 years.
 
Revenue Recognition

The Company recognizes revenue when the following criteria have been met: persuasive evidence of an arrangement exists, no significant Company obligations remain, collection of the related receivable is reasonably assured, and the fees are fixed or determinable. The Company acts as a principal in its revenue transactions as it is the primary obligor in the transactions.
Deferred Revenue and Deferred Costs

The Company defers revenue on contracts which contain a performance commitment until such time as the services have been completed and no significant Company obligations remain.

The costs associated with contracts for which revenue is deferred, including personnel costs and incremental contract costs, are initially capitalized as deferred costs. Subsequently these costs are recognized as a component of cost of revenue when the associated revenue is recognized.

In May 2016, the Company received formal written notice of termination of its Master Agreement with Sysmex Corporation (“Sysmex”) in a letter dated April 22, 2016. As a result of the termination, the Company has no further obligations with respect to the research agreement and related funding received.  Due to the unexpected termination by Sysmex, the Company recorded a gain from the contract termination of $248,074.

Foreign currency translation

The Company’s reporting and functional currency is US Dollars. The accounts of the Company’s 99.81% owned subsidiary, WL, and the Company’s 63% owned subsidiary, Bio-AMD Holdings, and Bio-AMD Holdings’ wholly owned subsidiary, Bio-Medical, and the Company’s 70% owned subsidiary UKH and its wholly owned subsidiary MML, are maintained using the local currency (Great British Pounds) as the functional currency. All assets and liabilities are translated into US Dollars at the balance sheet date, equity is translated at historical rates, and revenue and expense accounts are translated at the average exchange rate for the year or the reporting period. The translation adjustments are recorded as accumulated other comprehensive income.  Transaction gains and losses arising from exchange rate fluctuation on transactions denominated in a currency other than the functional currency are included in the consolidated statements of operations.

The relevant translation rates are as follows: For the nine month period ended September 30, 2016 closing rate at US$1.3015 per GBP, average rate at US$1.3921 per GBP and for the nine month period ended September 30, 2015 closing rate at US$1.5164 per GBP, average rate at US$1.5322 per GBP.

Recently Issued Accounting Standards

In February 2015, the FASB issued ASU No. 2015-02, Consolidation (Topic 810): Amendments to the Consolidation Analysis, which is intended to improve targeted areas of consolidation guidance for legal entities such as limited partnerships, limited liability corporations, and securitization structures (collateralized debt obligations, collateralized loan obligations, and mortgage-backed security transactions). The ASU focuses on the consolidation evaluation for reporting organizations that are required to evaluate whether they should consolidate certain legal entities. In addition to reducing the number of consolidation models from four to two, the new standard simplifies the FASB Accounting Standards Codification and improves current US GAAP by placing more emphasis on risk of loss when determining a controlling financial interest, reducing the frequency of the application of related-party guidance when determining a controlling financial interest in a variable interest entity (“VIE”), and changing consolidation conclusions for companies in several industries that typically make use of limited partnerships or VIEs. The ASU will be effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. The adoption of ASU 2015-02 did not have any effect on our financial position, results of operations or cash flows.
 
In August 2014, the FASB issued ASU No. 2014-15, “Presentation of Financial Statements - Going Concern (Subtopic 205-40)”. ASU 2014-15 provides guidance related to management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosure. ASU 2014-15 is effective for annual periods ending after December 15, 2016, and for interim and annual periods thereafter. Early application is permitted. We do not expect the adoption of ASU 2014-15 to have a material effect on our financial position, results of operations or cash flows.

In June 2014, the FASB issued ASU No. 2014-12, “Compensation – Stock Compensation (Topic 718): Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period.” This ASU requires that a performance target that affects vesting and that could be achieved after the requisite service period be treated as a performance condition. ASU 2014-12 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. The adoption of ASU 2014-12 did not have any effect on our financial position, results of operations or cash flows.

In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers (Topic 606).” ASU 2014-09 affects any entity using US GAAP that either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets unless those contracts are within the scope of other standards (e.g., insurance contracts or lease contracts). ASU 2014-09 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2016. We are still evaluating the effect of the adoption of ASU 2014-09. On April 1, 2015, the FASB voted to propose to defer the effective date of the new revenue recognition standard by one year.

Recent accounting pronouncements issued by the FASB and the SEC did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statements.
 
Note 3 – Patents

 
Cost
$
 
Accumulated amortization
$
   
Foreign currency translation adjustment
$
 
September 30,
2016
Net carrying value
$
 
December 31,
2015
Net carrying value
$
 
 
                     
Patents
   
200,738
     
     
(22,484
)
   
178,254
     
165, 848
 


The Company, through UKH and MML, currently has eight patent applications covering its three proprietary technology platforms. We continue to review our intellectual property strategy with the intention, within the constraints of our currently limited financial resources, of sufficiently protecting our key intangible assets, and that any new IP generated is reviewed as far as possible to optimize the novel nature of the IP and freedom to operate in key jurisdictions.
 
In June 2015, the Company received a grant of U.S. patent protecting twenty one claims central to the Company’s microfluidic strip and reader technology designed to test PT/INR by a POC device.

In January 2016, the Company received a grant of patent from the State Intellectual Property Office of the People’s Republic of China (“PRC”) for our MIDS technology. The Company has made similar MIDS technology patent applications in the U.K. and in more than 145 Contracting States under the international Patent Cooperation Treaty, and separately in the USA, the European Union and India.

In March 2016, the Company received notice of grant of patent from the State Intellectual Property Office of the PRC relating to our microfluidic strip and reader technology designed to test PT/INR by a POC device.

For the period ended September 30, 2016, there has been no amortization on the patents as they are still under development and have not been placed in use.
 
Note 4 – Related Party Transactions

During the three months ended September 30, 2016, we paid $nil (2015 - $46,613), to The ARM Partnership (“ARM”), a partnership in which Robert Galvin, our former Chief Financial Officer and Treasurer is a partner, for services provided to us by Mr. Galvin in all capacities. During the nine month period ended September 30, 2016, we paid an aggregate of $10,030 (2015 - $145,932) to ARM. Mr. Galvin owns 12.33% of the outstanding share capital of Bio-AMD Holdings. In addition, during the nine months ended September 30, 2016, the Company paid $nil (2015 - $9,750 (£14,800)) for the use of ARM’s offices in central London located at 3rd Floor, 14 South Molton Street, London, UK.
 
During the three month period ended September 30, 2016, we paid an aggregate of $9,269 (2015 - $36,175) to Thomas Barr, our Chief Executive Officer, for services provided to us by Mr. Barr in all capacities.  During the nine month period ended September 30, 2016, we paid an aggregate of $68,559 (2015 - $108,526) to Mr. Barr.

During the three month period ended September 30, 2016, we paid an aggregate of $4,833 (2015 - $23,494) to David Miller, our Chief Financial Officer, for services provided to us by Mr. Miller in all capacities. During the nine month period ended September 30, 2016, we paid an aggregate of $43,395 (2015 - $70,482) to Mr. Miller.
 
Note 5 – Deferred Revenue

Deferred revenue consists of funds received in advance of services being performed. The Company’s revenue recognition policy dictates that revenues will be recognized when the services have been completed and no significant Company obligations remain.

The costs directly associated with the performance of services for which revenue has been deferred are initially capitalized as deferred costs. These costs will be recognized as a component of cost of revenue when the associated revenue is recognized.

In May 2016, the Company received notice of termination of its Master Agreement with Sysmex. Upon receiving notice, management has determined that the Company has no further material obligations under the research agreement. The net difference between the deferred revenues and deferred costs of $248,074 has been recognized as a gain on termination of research agreement in the consolidated statements of operations.
 
Note 6 – Segmented Information

We currently operate in two segments: 1) the development of a technology designed to mitigate currency risk through our 99.81% owned subsidiary, WL as of September 30, 2016, and 2) the development of highly accurate, low cost, hand held, electronic medical diagnostic devices capable of reading third party assays through our 63% and 70% owned subsidiaries, Bio-AMD Holdings and Bio-AMD UK Holdings Limited, respectively. Segment information for the three and nine months ended September 30, 2016 and 2015 consists of the following:
 
Three months ended September 30, 2016:
 
 
WL
 
Bio-AMD Holdings &
Bio-AMD UK Holdings
 
Other
(Corporate)
 
Consolidated
 
 
               
Interest and other income
 
$
401
   
$
38
   
$
-
   
$
439
 
Segment net loss
   
(1,112
)
   
(38,922
)
   
(27,626
)
   
(67,660
)
Segment total assets
   
1,817
     
279,496
     
37,040
     
318,353
 


Three months ended September 30, 2015:
 
 
WL
 
Bio-AMD Holdings
 
Other
(Corporate)
 
Consolidated
 
 
               
Interest and other income
 
$
469
   
$
77,872
   
$
200
   
$
78,541
 
Segment net income (loss)
   
(3,332
)
   
60,491
     
(139,400
)
   
(82,241
)
Segment total assets
   
7,050
     
1,166,370
     
323,893
     
1,497,313
 


Nine months ended September 30 2016:

 
WL
 
Bio-AMD Holdings &
Bio-AMD UK
 
Other
(Corporate)
 
Consolidated
 
 
               
Interest and other income
 
$
1,261
   
$
38
   
$
102
   
$
1,401
 
Segment net income (loss)
   
(5,130
)
   
187,522
     
(258,610
)
   
(76,218
)
Segment total assets
   
1,817
     
279,496
     
37,040
     
318,353
 


Nine months ended September 2015:

 
WL
 
Bio-AMD Holdings
 
Other
(Corporate)
 
Consolidated
 
 
               
Interest and other income
 
$
1,390
   
$
77,872
   
$
802
   
$
80,064
 
Segment net loss
   
(36,856
)
   
24,032
     
(646,389
)
   
(659,213
)
Segment total assets
   
7,050
     
1,166,370
     
323,893
     
1,497,313
 

Note 7 – Commitment

As previously described in Note 1, effective July 1, 2016, the Company has formed a joint venture agreement for the Phase 1 development of MIDS technological application.  The Company has agreed, to prospectively issue 3,000,000 five year warrants in the Company exercisable at $0.10 per share, to certain third parties (or their nominees) who have introduced the joint venture partner to the Company. The warrants may be issued at any time up to MML receiving the final Phase 1 Payment and they may not be exercised prior to June 15, 2017.

Management evaluated all activities of the Company through the issuance date of the Company’s interim unaudited condensed consolidated financial statements and concluded that no further subsequent events have occurred that would require adjustments or disclosure into the interim unaudited condensed consolidated financial statements.

Note 8 – Subsequent Event
 

(a)
On October 28, 2016 and November 2, 2016, the Company received further payments of $30,000 and $110,000, respectively, from the Partner in relation to the Phase 1 Payments pursuant to the Agreement.

(b)
On November 14, 2016, the Company issued 7,600,000 cashless warrants with “piggy-back” registration rights to the Chief Executive Officer and Chief Financial Officer of the Company with an exercise price of $0.07 per warrant with an expiration date of November 14, 2023, of which 4,100,000 warrants are vested immediately and 3,500,000 warrants will vest upon the first commercial sales of any MIDS-based products. 
ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
Statement Regarding Forward-Looking Information
 
This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts included in this Quarterly Report on Form 10-Q, including without limitation, statements in this Management’s Discussion and Analysis of Financial Condition and Results of Operations regarding our financial position, estimated working capital, business strategy, the plans and objectives of our management for future operations and those statements preceded by, followed by or that otherwise include the words “believe”, “expects”, “anticipates”, “intends”, “estimates”, “projects”, “target”, “goal”, “plans”, “objective”, “should”, or similar expressions or variations on such expressions are forward-looking statements. We can give no assurances that the assumptions upon which the forward-looking statements are based will prove to be correct. Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by the forward-looking statements. There are many risks, uncertainties and other important factors that could cause our actual results to differ materially from the forward-looking statements, including, but not limited to, the availability and pricing of additional capital to finance operations.
 
Except as otherwise required by the federal securities laws, we disclaim any obligations or undertaking to publicly release any updates or revisions to any forward-looking statement contained in this Quarterly Report on Form 10-Q to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
 
The following discussion should be read in conjunction with our unaudited condensed consolidated financial statements and the accompanying notes included elsewhere in this Quarterly Report on Form 10-Q.
 
Overview
 
We were incorporated in the State of Nevada under the name Malibu Minerals, Inc. on March 10, 2006, to engage in the business of exploration and discovery of gold, minerals, mineral deposits and reserves. On July 6, 2007 we changed our name to Flex Fuels Energy, Inc. through a merger effected for that sole purpose. On April 15, 2011, we changed our name to Bio-AMD, Inc. through a merger effected for that sole purpose. During the fourth quarter of 2006, we acquired a 15% interest in Flex Fuels Energy Limited (“FFE Ltd.”). In May 2007, we completed the acquisition of the remaining 85% of FFE Ltd., making FFE Ltd. a wholly owned subsidiary of ours.  FFE Ltd. was formed on November 26, 2006 under the laws of England and Wales to engage in the business of manufacturing and distributing Oil Seed Rape (“OSR”) products. Effective September 5, 2009, we determined to abandon FFE Ltd.’s proposed OSR business and related projects as we no longer considered the business to be economically viable on either a go alone or partnered basis. FFE Ltd was dissolved in February 2011 and the final winding down accounting transaction took place in May 2011.
 
On May 1, 2009, we acquired stock of WDX Organisation Limited, a corporation incorporated under the laws of England and Wales representing a 51% interest in the company. WDX Organisation Limited changed its name to WOCU Limited (“WL”) effective January 29, 2013. Since May 1, 2009, we have acquired additional stock of WL and since July 12, 2012 we have owned 99.81% of WL making it a majority owned subsidiary of ours. WL is the developer of a technology designed to mitigate currency risk.
 
On February 25, 2010, we entered into a Subscription and Shareholders Agreement with Bio AMD Holdings Limited (“Bio-AMD”), a UK limited company, and the managers of Bio-AMD, under which we acquired 63% of the fully diluted equity in Bio-AMD for £865,000 GBP (approximately $1,287,000 at the time of purchase). Bio-AMD is a technology company focused in the rapidly expanding medical diagnostic Point Of Care (“POC”) market. Bio-AMD currently has eight patent applications pending or granted covering its three technology platforms.


Restructuring of Bio-AMD Holdings and Bio-Medical operations

On June 1, 2016, the intellectual property relating to the Company’s DSR, COAG and MIDS projects (the “IP”) and depreciated physical equipment assets (together the “Assets”), formerly under the control of Bio-AMD Holdings and Bio-Medical, into the full control of Bio-AMD, Inc. as a result of the loan security put in place by the Company during 2015. On October 10, 2016 Mr Robert Galvin, our former CFO and Treasurer, was removed as a director of Bio-AMD Holdings and Bio-Medical.

On June 17, 2016, the Company entered into a Subscription and Shareholders’ Agreement with Bio-AMD UK Holdings Limited (“UKH”), a United Kingdom company, and the managers of UKH, under which we acquired a 70% interest in UKH in exchange for the Assets.

UKH is a development stage company, formed in May 2009 by the Company’s two principal and key scientists formerly contracted to Holdings, Dr. Nasser Djennati and Dr. Andrew Mitchell. UKH was formerly dormant and has never traded. Immediately prior to the transaction UKH formed a new subsidiary, MIDS Medical Limited (“MML”) as a dedicated vehicle to develop our MIDS universal immunoassay detection technology in a joint venture, further described below. UKH has taken over the operations of Holdings and Bio-Medical.
 
The 30% of UKH not owned by the Company is owned by Dr. Nasser Djennati (15%) and Dr. Andrew Mitchell (15%). The board of directors of both UKH and MML consists of Drs. Djennati and Mitchell, and Mr Barr, the Company’s CEO.
 
The effect of the restructuring was to beneficially increase the Company’s interest in its UK operations from 63% to 70%, to simplify and gain better voting control of its UK subsidiaries, and to eliminate two employee profit share arrangements.

 
MIDS Medical Limited Operations
 
On June 20, 2016, the Company and its UKH and MML subsidiaries entered into a joint venture by way of a Subscription and Shareholders’ Agreement (“Agreement”) with a third party medical detection device developer (“Partner”) a Nevada corporation, under which the Partner, in exchange for its participation and funding to support MML during a Phase 1 development, owns a 40% interest in MML as of July 1, 2016, The Partner also prospectively agreed to fund a Phase 2 development of our MIDS universal immunoassay detection technology within the MML vehicle. MML will have the right to use the MIDS Intellectual Property (“MIDS IP”) under license during the development and the MIDS IP will be transferred to MML in the event that MML concludes a commercial deal for MIDS with a third party.
 
The Agreement, as amended, provides for a series of payments (“Phase 1 Payments”) in an aggregate amount of $650,000.

Business Overview
 
During the quarter ended September 30, 2016, we were engaged in the following sectors:
 
·
developing our POC medical diagnostic business; and

·
developing our currency risk mitigation business.
 
Operations - Medical

The trend toward greater POC testing is driven by the faster diagnostic benefits it provides.  Other reasons have also emerged for the high demand of POC testing, including clinical staff shortages, an ageing population, long-term healthcare cost savings and a decrease in reliance on conventional laboratory services.

We believe that Bio-AMD is an innovator in the field of diagnostic sensor technology, with the attributes of its technology platform fitting well with these key trends:
 
· A disposable micro-fluidic test strip which has been adapted to measure prothrombin time (PT/INR) and designed to be capable of performing additional coagulation related tests such as APTT and DTI, through a POC blood coagulation monitoring device (“COAG”) enabling patient based, anticoagulant drug therapy monitoring;
· A Digital Strip Reader (“DSR”) able to read a wide variety of lateral flow based immunoassay diagnostic test strips already in the POC market including, but not limited to, cardiac markers, infectious diseases, drugs of abuse and female wellbeing (pregnancy/ovulation testing) to provide semi-quantitative results; and
· A disposable test strip combining micro-fluidics and ‘lab-on-chip’ technology providing fully quantitative measurement into a highly sensitive and accurate immunoassay POC platform that detects nanoparticles through magnetic manipulation using a novel magnetic and optical double detection technique – Magnetic Immunoassay Detection System (“MIDS”).
COAG

Bio-AMD’s micro-fluidic strip technology has been applied for use in a POC hand-held device to detect prothrombin time (“PT”)/International Normalized Ratio (“INR”), or the speed of blood coagulation. In 2013, the POC coagulation market for PT/INR measurement was estimated to be worth approximately US$870 million globally and projected to grow to an estimated US$1.1 billion by 2017.  Market growth is driven by the rising number of patients using anti-coagulation therapy, growing clinical evidence supporting the use of such testing and strong patient demand for patient self-testing. The market is dominated by a small number of major players including Alere, Roche, Siemens and Philips who have either developed products internally or have acquired exclusive rights to license appropriate technologies from smaller companies.  Patients with cardiac problems are often on life-long oral anticoagulation therapy, for example Warfarin. Frequent testing and careful monitoring of the PT/INR or blood coagulation to regulate the doses of anticoagulation therapy is a necessity.  A patient taking too much anticoagulant is at risk of serious bleeding events and if too little is taken they may be at risk of thrombosis.  

Bio-AMD has established a design that allows for low cost manufacture of the disposable strip whilst ensuring scalability and repeatability.  We have performed extensive in-house bench tests at our laboratory and further tested in an initial hospital study producing comparable results to the current ‘best in market’ devices, which we believe validates the feasibility of our design.

In late 2013, we filed a patent application for a multi-chamber microfluidic strip design, incorporating a novel locking mechanism that allows for the control of fluid flow through the strip.  In addition to being able to test for PT/INR which requires the presence of a single reagent in the immunoassay testing process this enhanced strip design enables additional coagulation based tests requiring the use of multiple reagents in the immunoassay process, e.g. Activated Partial Thromboplastin Time (“APTT”), a laboratory based test used to measure the activity of direct thrombin inhibitors.

In June 2015, we received notice of the grant of a U.S. patent dated June 2, 2015, under U.S. Patent No. US 9,046,512 protecting twenty one claims central to the Company’s microfluidic strip and reader technology designed to test PT/INR by a POC device.
 
We plan to apply the new strip design to multiple, different coagulation specific tests utilizing a common hand held reader device to display the results.  For example, a clinician testing for PT/INR would use a specific PT/INR strip and record the result from the reader. The clinician would then be able to test for APTT using a separate APTT specific strip using the same reader device. The test strips would use a common plastic component design, which we believe will reduce overall production costs.
 
Launching a product into the coagulation market that incorporates our COAG technology will require us to partner with a much larger, suitable business with the requisite capital resources and skills including distribution and sales channels, and ideally global marketing expertise in sectors such as hematology and immunochemistry.  Our strategy for commercialization of COAG has centered on attracting a suitable partner that fits this profile, and which is keen to add coagulation based POC system to its existing product line.


On December 17, 2014, Bio-Medical entered into a Master Agreement (the “Agreement”) with Sysmex Corporation (“Sysmex”) pursuant to which the parties planned to jointly conduct a feasibility study (the “Study”) for the potential development of our POC COAG system including a reader device with disposable test strips for PT-INR assays and potentially new future assays in the field of hemostasis (the “Products’).  An expense advance of £642,067 (approximately $980,000) was made to Bio-Medical by Sysmex in 2015. The Study, we believe, was successfully completed and the preliminary results were presented to Sysmex in late 2015. Notwithstanding the conclusions of the Study, Sysmex decided in April 2016 to discontinue funding the Study and indicated that it would not proceed with it in the future. No new intellectual property was developed during the Study and the temporary research license granted to Sysmex by the Company to use the Company’s intellectual property has been automatically terminated.
 
The Company believes that its COAG technology is now well advanced and performs better than expected when compared to gold standard lab analyzers and the market-dominant POC PT/INR self-test device, CoaguChekXS. The Company believes that COAG broadly matches the accuracy performance of those tests even on an un-optimized test rig. Our data suggest that a finalized, optimized COAG device is expected to be a leader on POC accuracy, with a sub 5% coefficient of variance, in an environment where the FDA is seeking higher PT/INR self-test accuracy requirements. We believe that COAG has been proven to operate on a patient-friendly, minimal 5 microliter pin prick blood sample, which is materially smaller than any other device available in the market. Accordingly the Company continues to believe that COAG should be of interest to major POC providers desiring to service the vitamin K antagonist POC monitoring market.

Whilst we have received some initial interest there can be no assurance that we will enter into any new agreement to jointly develop COAG or to otherwise commercialize COAG.

DSR

The DSR technology platform utilizes a patented proprietary method for reading and quantifying traditional chromatography based, nitro-cellulose, lateral-flow immunoassay tests, centered on what we believe to be a unique optical sensor arrangement.  The DSR technology comprises a proprietary design incorporating sensors, diagnostics, display and power management capabilities.  We believe that a key feature of the DSR technology is that its platform can be adapted and applied to numerous and disparate lateral flow diagnostic tests.
 
Bio-AMD has created designs for both single and multi-test versions of the DSR hand-held reader device and laboratory based bench tests have been performed by us in our premises using a variety of third party lateral flow strips.  The DSR device is designed to be fully disposable and can be powered by solar power cells, although traditional battery power sources can also be used.  Our multi-test device utilizes a replaceable cap system in which a new test strip is fitted, thereby enabling the hand-held reader to be used multiple times for the same test.  By way of example, existing over the counter (“OTC”) home fertility testing packs normally contain up to 20 separate identical tests; for this fertility application our device would require just one reader device with 20 caps, each cap containing the test strip, thereby reducing the number of component parts and manufacturing cost.

The market for female well-being, which includes digital home pregnancy and fertility testing, was estimated to be worth approximately $1.5 billion globally in 2012.  Whilst the market for pregnancy testing is very competitive and dominated by a small number of large global brands e.g. Clearblue, Predictor and First Response, in several regions, particularly Asia, there is demonstrated demand from local distributors for OEM produced digital pregnancy test kits (“PTK”), the key factors being price and marketability by way of unique product features. Options for DSR might include creating our own branded and/or OEM digital pregnancy testing kit, or partnering with a qualified distributor aiming to launch a branded product into the region.  This might entail our finalizing a product manufacturing design file and obtaining appropriate territorial regulatory approval specifically for the Asian market. Such a strategy will require additional capital, which we cannot guarantee would be available on terms acceptable to us or at all.
 
We have also been exploring, at an early stage, the potential to add value to diagnostic screening campaigns led by the National Health Service (“NHS”) in the UK. 


MIDS

Demand is increasing for POC tests that can detect very low concentrations of a target analyte and to quantify the result.  Current lateral flow based immunoassays can detect analyte at high levels of concentration.  However, at low concentration levels, the assay system requires amplification either of the signal or the target, which will typically increase the complexity and the costs of the testing device.  Consequently, current POC tests remain largely unreliable for targets that require quantification.

We believe there to be an opportunity to develop a universal immunoassay based POC testing system which:

Is capable of detecting biomarkers at a nanoparticle level, providing fully quantitative measurement of results i.e. giving a numerical value for the biomarker detected and not just an indication on whether a specified biomarker is actually present,
Is capable of multiplexing i.e. performing multiple types of test from the same sample,
Provides full connectivity and networking for collection, storage and transfer of data and results,
Displays test results in minutes (less than 8 minutes for a panel of up to 3 tests),
Requires a finger prick sample size for a single test,
Utilizes a handheld reader and single disposable cartridge designed to be operated by a minimally trained person, requiring modest manual operation, other than for sample collection,
Contains all necessary reagents and where all steps are automated into an integrated encompassing pre-treatment, analyte specific reaction, signal production, signal reaction and final result: from sample to result in one step,
Can be adapted to perform different immunoassays for testing in areas such as infectious diseases, drugs of abuse or oncology, especially where rapid diagnosis is critical, and
Has a simple system design, requiring minimal direct input costs and inline manufacturing processes to keep unit costs as low as possible.
 
The technology will incorporate what we believe to be a novel microfluidic strip design, magnetic nanoparticle manipulation and a unique double detection technique using bespoke ‘Hall Effect’ sensors and bespoke optical sensor which, when combined, will increase significantly the sensitivity and accuracy of the result.  We are not aware that this method is being used in products currently being offered in the market or in development.

We plan to develop the immunoassay platform initially for the high sensitivity cardiac marker POC testing market, which are measured to evaluate heart function.  Cardiac markers are used in the diagnosis and risk stratification of patients with chest pain and suspected acute coronary syndrome.  The detection of these markers is used to diagnose myocardial infarction and its severity, typically troponin (cTnI or cTnT), myoglobin and Creatine kinase MB isoenzyme (CK-MB). Our ultimate aim is to commercialize a product for the multiple cardiac marker testing market which was estimated by BCC Research to be worth US $1.3 billion globally in 2013 (including device, reagent and supply sales), and is expected to grow to $2.4 billion by 2018.

Additionally, we envisage the technology platform to be adaptable and be extended into new test areas, e.g. infectious diseases, drugs of abuse and oncology; having potential to expand into a multifunctional device, i.e. one analyzer using different strips for different tests; and can be introduced into high growth areas such as companion diagnostics (where POC devices are used to optimize the personalized dosage of a therapeutic drug).

We believe that our MIDS technology has considerable potential to create a next generation of POC test devices. Our proposed method aims to bring together biology, chemistry, nano-fluidics, and electronics and, ‘lab-on-chip’ technology together into what we believe can be unique, economically viable products.

To date some very early stage work has been completed in conjunction with the Science, Technology and Facilities Council, one of Europe’s largest independent scientific research public body organizations in-part funded by the UK Government.  In April 2011 we made an initial patent application for the technology and in October 2012 we entered into the national phase stage, making applications in Europe, US, India and China, with a Chinese patent being granted in March 2016

On June 20, 2016, the Company and its UKH and MML subsidiaries entered into a joint venture by way of a Subscription and Shareholders’ Agreement (“Agreement”) with a third party medical detection device developer (“Partner”) a Nevada corporation, under which the Partner, in exchange for its participation and funding to support MML during a Phase 1 development, owns a 40% interest in MML as of July 1, 2016, The Partner also prospectively agreed to fund a Phase 2 development of our MIDS universal immunoassay detection technology within the MML vehicle. The Agreement as amended provides for a series of payments (“Phase 1 Payments”) in an aggregate amount of $650,000.

Initial development has commenced on the MIDS project, including the specification of a bench rig printed circuit board designed to support first stage testing of a sample of Hall Effect Sensors already supplied to MML in order to examine their behavior in the detection of magnetic nanoparticles – the core MIDS technology – and to determine how these Hall Effect Sensors should be optimized prior to integration in a micro fluidic test strip.

Since January 2014, the Company has provided additional working capital by way of cash injections via intercompany loans amounting to £100,000 (approximately $122,000) to Bio-AMD Holdings to further fund operations. These loans were secured against the assets of Bio-AMD Holdings and its wholly owned operating subsidiary, Bio Medical. These assets have now been transferred to UKH as a result of the security.

To date, no revenues had been generated by Bio-AMD Holdings or UKH.  

Operations - WL - Currency Risk Mitigating Business

WL is the creator of a proprietary algorithm that produces a global currency derivative quotation known as the WOCU®.  The WOCU can be applied to financial products provided by third parties such as index structure products, exchange traded funds or derivate contracts, with a view to mitigating any currency risk inherent within those products. The WOCU algorithm was completed in June 2009, with further work including back-testing using historical foreign exchange data, to prove the attributes of the WOCU design, taking place throughout 2010 until the WOCU’s launch late that year.  Since that time, the WL management team has sought to achieve licensing deals with a variety of financial institutions that are seeking to create financial products denominated in WOCU.

The WOCU’s generally low volatility against fiat currencies offers huge commercial advantages as a unit of account for the denomination of world trade, compared to the status quo of cross border trade denominated in fiat currency pairs, or in US Dollars.  Transactions across currencies (except in isolated cases where one exchange rate is “pegged” to the other) inevitably involve potential foreign exchange risk caused by movements in exchange rates. The advantage of denominating a transaction involving foreign exchange in WOCU’s is that can lower the foreign exchange (“FX”) volatility as compared to traditional exchange rate pairs.

The WOCU, subject to the achievement of the WL corporate strategy and business model described below, is expected to have application to:
 
·
Multinational corporate treasury operations;

·
Reference pricing for general global trade;

·
Reference pricing for currency, fixing, including virtual, online currencies;

·
Commodity pricing and trade;

·
Currency balanced savings accounts;

·
Fund management, including Exchange Traded Funds;

·
FX and derivative trading and speculation;

·
Global index calculations; and

·
Reserve ratio applications (similar to the IMF’s Special Drawing Right or SDR).
 

The WOCU’s apolitical, bank-independent, transparent, instant availability and universal nature are believed to be a key differentiator compared to alternative methods of hedging against currency risk.
 
The WOCU quotation is calculated and published by WL as daily and hourly fixed reference prices for a total of 169 fiat currencies, digital currencies and commodities. In addition WOCU Foreign Exchange (“FX”) 1, 2, 3, 6, 9 and 12 month Forward quotations will be produced by WL against the USD, from which a Forward WOCU rate can be calculated for any currency for which Forward rates are currently quoted, plus WOCU Interest Rate forward quotations covering the Overnight 1, 2, 3, 6, 9 and 12 month money market periods. The WOCU reference price is fixed daily at 16:00 UTC against all major currencies and is also available as an hourly reference price, from 00:00 Monday to 23:00 Friday, and as hourly price captures for gold, silver and oil.
 
The WOCU quotation is available (non-exclusively) from WL’s re-seller Interactive Data Corporation (“IDC”) via its data terminals and data feeds under the ticker symbol XCU. IDC currently calculates and offers quotations for 47 WOCU based currency pairs, and 6 commodities, as cross rates and supplies a stand-alone WOCU real-time charting package application via IDC’s PrimePortal™ application. WOCU rates are also available on the professional Thompson Reuters platform and on the UK’s leading retail price data platform ADVFN.
 
The WOCU quotation is also available via a mobile application for Apple mobile devices known as “WOCU”. This application supports five languages; English, simplified Chinese, traditional Chinese, Japanese and Korean.  The WOCU quotation is also available as an hourly reference price available directly from WL by RSS feed, e-mail and via WL’s FTP server. The WOCU quotation as an hourly updated price is also available from the Company’s corporate website www.wocu.com

WL has established relationships with a number of individuals and organizations authorized to serve as introducing agents (“IAs”) to the WL business, charged with identifying suitable prospects that fit the WL target profile.   These IAs are remunerated purely on a contingent basis linked only to successful results and each IA generally is responsible for its own expenses. The exact terms of any IA arrangement is agreed between WL and the IA on a case by case basis.  IAs are chosen based on their experience and knowledge of the financial markets and their deep contact network. To date six such IAs have been appointed.
 
Since January 2013, the Company has provided further advances totaling £196,000 (approximately $260,000) into WL to fund its anticipated operations based on the prospective pipeline of opportunities that have been generated.

WL has not achieved any operating revenues to date and does not expect to achieve operating revenues until such time, if ever, that the WOCU is successfully marketed.

Given the Company's limited resources, it is unlikely that the Company can support WL operations going forward, as a contractor to WL vital to its technical operation has indicated it is not willing to continue to provide its services at the current much reduced rate of payment and accordingly further investment will be required to support WL. The Company is considering any option that might preserve any value in WL and is considering an offer from the contractor and our CEO, Mr Thomas Barr, to purchase the Company's shares in WL in exchange for nominal consideration and a future payment contingent on the future success of WL, if any.

Results of Operations
 
Losses from Operations

We incurred losses from operations of $68,099 and $325,693 for the three and nine month periods ended September 30, 2016, respectively, compared to losses from operations of $160,781 and $739,277 for the three and nine month periods ended September 30, 2015, respectively. 

The main components of the recorded operating loss during the three and nine month periods ended September 30, 2016 compared to losses from continuing operations during the three and nine month periods ended September 30, 2015 were as follows:
  
 
       
3 months ended September 30,
   
9 months ended September 30,
 
 
 
Note
   
2016
   
2015
   
2016
   
2015
 
Consulting expenses
 
1
     
19,871
     
106,516
     
194,376
     
332,570
 
Professional fees
 
2
     
9,457
     
70,156
     
39,514
     
83,910
 
Rent, office expense, and miscellaneous
 
3
     
9,606
     
20,038
     
31,182
     
66,483
 
Stock-based compensation
 
4
     
0
     
15,000
     
0
     
223,000
 

(1)           Consulting expenses decreased by $86,645 to $19,871 for the three month period ended September 30, 2016, compared to $106,516 for the three month period ended September 30, 2015 and decreased by $138,194 to $194,376 for the nine month period ended September 30, 2016 compared to $332,570 for the nine month period ended September 30, 2015. Consulting expenses includes consultants engaged with the management and administration of the Company utilized in the course of our operations and those of our subsidiaries. These officers/consultants have recently received a reduced fee which commenced at the beginning of March 2016. 
 
(2)           Professional fees comprised primarily of audit and financial compliance related costs, remained static for the three month period ended September 30, 2016 and decreased by $44,396 from $83,910 for the nine month period ended September 30, 2016 to $39,514 for the nine month period ended September 30, 2015. The reduction was primarily due to a change of auditor, and lower business activity compared to the prior year.
 
(3)           Rent, office expense, and miscellaneous expense was $9,606 for the three month period ended September 30, 2016 compared to $20,038 for the three month period ended September 30, 2015 and was $31,182 for the nine month period ended September 30, 2016 compared to $66,483 for the nine month period ended September 30, 2015. The decrease of $37,429 for the nine month period ended September 2016 can mainly be attributed to a decrease in rent expense incurred in Bio-AMD and a decrease in travel expenses in Bio-Medical.

(4)           Stock-based compensation was $nil for the three month period ended September 30, 2016 compared to $15,000 for the three month period ended September 30, 2015 and was $nil for the nine month period ended September 30, 2016 compared to $223,000 for the nine month period ended September 30, 2015. The decrease of $223,000 for the nine month period ended September 2016 can mainly be attributed to that fact the Company did not issue any stock-based compensation during the nine month period ended September 30, 2016 whereas the Company issued 1,150,000 restricted shares of common stock with a fair value of $184,000 in relation to a consulting agreement dated September 9, 2015 as well as recognizing $24,000 for the nine month period ended September 30, 2015 in relation to 300,000 restricted shares of stock options issued for investor relationship services provided to the Company over a period of twelve months.

Revenues
 
We have not generated any revenues from operations for the three and nine month periods ended September 30, 2016 and 2015.
 
Other Income
 
We recorded other income during the three and nine month periods ended September 30, 2016 of $439 and $249,475, respectively, as compared to $78,541 and $80,065 for the three and nine month periods ended September 30, 2015, respectively.  The increase in other income over the three and nine month periods relates to a $248,074 gain on termination of research agreement due to the termination of the Master Agreement by Sysmex. The decrease in other income for the three month period is due to the fact that the Company received grant income of $77,872 in the prior year.

Net Losses
 
We generated a net loss of $67,660 and $76,218 for the three and nine month periods ended September 30, 2016, respectively, as compared to a net loss of $82,240 and $659,212 for the three and nine month periods ended September 30, 2015, respectively, for the reasons discussed above. Our loss per share was $0.00 for the three months ended September 30, 2016 and 2015, and for the nine months ended September 30, 2016. Our loss per share was $0.01 for the nine months ended September 30, 2015.

Liquidity and Capital Resources
 
We have limited cash reserves and may need substantial amounts of capital to implement our planned business strategies.  Given the currently unsettled state of the capital markets and credit markets, there is no assurance that we will be able to raise the amount of capital that we may seek to support our working capital requirements or for further investment in current and future operations.  If we are unable to raise the necessary capital at the times we require such funding, we may have to materially change our business plan, delaying implementation of aspects of our business plan or curtailing or abandoning our business plan.  Investing in us is a speculative investment and investors may lose all of their investment.
 
Since our inception, we have been financed primarily by the sale of equity in private placements.  At September 30, 2016, we had cash of $122,952; other current assets of $17,009 consisting of amounts receivable, and prepaid expenses, and we had current liabilities of $77,436, consisting of accounts payable, accrued liabilities, and other liabilities.  We attribute our operating loss to having no operating revenues to sustain our operating costs. These factors raise substantial doubt about our ability to continue as a going concern.
   
Net Cash Provided by/Used in Operating Activities
 
Net cash used in operating activities of operations was $388,225 for the nine months ended September 30, 2016, as compared to net cash provided of $65,312 for the nine months ended September 30, 2015. The decrease is primarily related to the loss of research funding under the former Master Agreement with Sysmex.
 
Net Cash Used in Investing Activities
 
During the nine months ended September 30, 2016, the Company paid $34,890 for patent applications.  The Company had no investing activities during the nine months ended September 30, 2015.

Net Cash Provided by Financing Activities
 
During the nine month period ended September 30, 2016, the Company received $130,000 as part of the participation funding of a Phase I program under the Agreement. The Company had no financing activities during the nine months ended September 30, 2015.
 
Critical Accounting Policies and Estimates
 
Significant Accounting Policies
 
Financial Reporting Release No. 60, published by the SEC, recommends that all companies include a discussion of critical accounting policies used in the preparation of their financial statements. While all these significant accounting policies impact our consolidated financial condition and results of operations, we view certain of these policies as critical.  Policies determined to be critical are those policies that have the most significant impact on our consolidated financial statements and require management to use a greater degree of judgment and estimates. Actual results may differ from those estimates.

We believe that given current facts and circumstances, it is unlikely that applying any other reasonable judgments or estimate methodologies would cause a material effect on our unaudited condensed consolidated results of operations, financial position or liquidity for the periods presented in this report. 

General  

The Company’s consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles, which require management to make estimates, judgments and assumptions that affect the reported amounts of assets, liabilities, net revenue, if any, and expenses, and the disclosure of contingent assets and liabilities.  Management bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.  Senior management has discussed the development, selection and disclosure of these estimates with the Board of Directors.  Management believes that the accounting estimates employed and the resulting balances are reasonable; however, actual results may differ from these estimates under different assumptions or conditions. 

An accounting policy is deemed to be critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made, if different estimates reasonably could have been used, or if changes in the estimate that are reasonably possible could materially impact the consolidated financial statements. Management believes the following critical accounting policies reflect the significant estimates and assumptions used in the preparation of the consolidated financial statements.

Revenue Recognition

The Company recognizes revenue when the following criteria have been met: persuasive evidence of an arrangement exists, no significant Company obligations remain, collection of the related receivable is reasonably assured, and the fees are fixed or determinable. The Company acts as a principal in its revenue transactions as the Company is the primary obligor in the transactions.

Deferred Revenue and Deferred Costs

The Company defers revenue on contracts which contain a performance commitment until such time as the services have been completed and no significant Company obligations remain.
 
Foreign Currency Translation
 
The Company’s reporting and functional currency is US Dollars. The accounts of the Company’s 99.81% owned subsidiary, WL, and the Company’s 63% owned subsidiary, Bio-AMD Holdings, and Bio-AMD Holdings Limited’s wholly owned subsidiary, Bio-Medical, and the Company’s 70% owned Subsidiary UKH and its 60% owned subsidiary MML, are maintained using the local currency (Great British Pound) as the functional currency. All assets and liabilities are translated into US Dollars at balance sheet date, equity is translated at historical rate and revenue and expense accounts are translated at the average exchange rate for the year or the reporting period. The translation adjustments are deferred as a separate component of stockholders’ equity, captioned as accumulated other comprehensive (loss) gain.  Transaction gains and losses arising from exchange rate fluctuation on transactions denominated in a currency other than the functional currency are included in the consolidated statements of operations.
 
The relevant translation rates are as follows: For the nine month period ended September 30, 2016 closing rate at US$1.3015 per GBP, average rate at US$1.3921 per GBP and for the nine month period ended September 30, 2015 closing rate at US$1.5164 per GBP, average rate at US$1.5322 per GBP.

Recent accounting pronouncements
 
In February 2015, the FASB issued ASU No. 2015-02, Consolidation (Topic 810): Amendments to the Consolidation Analysis, which is intended to improve targeted areas of consolidation guidance for legal entities such as limited partnerships, limited liability corporations, and securitization structures (collateralized debt obligations, collateralized loan obligations, and mortgage-backed security transactions). The ASU focuses on the consolidation evaluation for reporting organizations that are required to evaluate whether they should consolidate certain legal entities. In addition to reducing the number of consolidation models from four to two, the new standard simplifies the FASB Accounting Standards Codification and improves current U.S. GAAP by placing more emphasis on risk of loss when determining a controlling financial interest, reducing the frequency of the application of related-party guidance when determining a controlling financial interest in a variable interest entity (“VIE”), and changing consolidation conclusions for companies in several industries that typically make use of limited partnerships or VIEs. The ASU will be effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. The adoption of ASU 2015-02 did not have any effect on our financial position, results of operations or cash flows. 


In August 2014, the FASB issued ASU No. 2014-15, “Presentation of Financial Statements - Going Concern (Subtopic 205-40)”. ASU 2014-15 provides guidance related to management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosure. ASU 2014-15 is effective for annual periods ending after December 15, 2016, and for interim and annual periods thereafter. Early application is permitted. We do not expect the adoption of ASU 2014-15 to have a material effect on our financial position, results of operations or cash flows.

In June 2014, the FASB issued ASU No. 2014-12, “Compensation – Stock Compensation (Topic 718): Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period.” This ASU requires that a performance target that affects vesting and that could be achieved after the requisite service period be treated as a performance condition. ASU 2014-12 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. The adoption of ASU 2014-12 did not have any effect on our financial position, results of operations or cash flows.

In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers (Topic 606).” ASU 2014-09 affects any entity using U.S. GAAP that either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets unless those contracts are within the scope of other standards (e.g., insurance contracts or lease contracts). ASU 2014-09 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2016. We are still evaluating the effect of the adoption of ASU 2014-09. On April 1, 2015, the FASB voted to propose to defer the effective date of the new revenue recognition standard by one year.

Other recent accounting pronouncements issued by the FASB and the SEC did not, or are not believed by management to have a material impact on the Company’s present or future unaudited condensed consolidated financial statements. 
 
Off-Balance Sheet Arrangements
 
We have no off-balance sheet arrangements.
 
Inflation

We believe that inflation has not had, and is not expected to have, a material effect on our operations.

Climate Change

We believe that neither climate change, nor governmental regulations related to climate change, have had, or are expected to have, any material effect on our operations. 

ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
Not applicable.

ITEM 4.  CONTROLS AND PROCEDURES
 
Evaluation of Disclosure Controls and Procedures
 
We maintain disclosure controls and procedures that are designed to ensure that material information required to be disclosed in our periodic reports filed under the Securities Exchange Act of 1934, as amended, or 1934 Act, is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and to ensure that such information is accumulated and communicated to our management, including our chief executive officer and chief financial officer as appropriate, to allow timely decisions regarding required disclosure. During the quarter ended September 30, 2016, we carried out an evaluation, under the supervision and with the participation of our management, including the principal executive officer and the principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rule 13(a)-15(e) under the 1934 Act. Based on this evaluation, our chief executive officer and chief financial officer have concluded that as of September 30, 2016, our disclosure controls and procedures were not effective because (1) the Company lacks a functioning audit committee and there is a lack of independent directors on the board of directors, resulting in reduced oversight in the establishment and monitoring of required internal controls and procedures; (2) the Company has inadequate segregation of duties consistent with control objectives; and (3) the Company has ineffective controls over its period end financial disclosure and reporting processes. The Company operations are also ineffective due to the lack of operating funding.

Saturna Group Chartered Professional Accountants LLP, our independent auditors, were not required to and have not provided an assessment of our internal controls and procedures.
 
Limitations on Effectiveness of Controls and Procedures
 
Our management, including our Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial Officer), does not expect that our disclosure controls and procedures will prevent all errors and all 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. Further, 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. Because of 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, within the Company have been detected. These inherent limitations include, but are not limited to, the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
 
Changes in Internal Controls
 
During the fiscal quarter ended September 30, 2016, there were no changes in our internal controls.,

PART II – OTHER INFORMATION
 
ITEM 1.  LEGAL PROCEEDINGS
 
From time to time we may be a defendant or plaintiff in various legal proceedings arising in the normal course of our business. We are currently not a party to any material legal proceedings or government actions, including any bankruptcy, receivership, or similar proceedings. In addition, we are not aware of any litigation or liabilities involving the operators of our properties that could affect our operations. Furthermore, as of the date of this Quarterly Report, our management is not aware of any proceedings to which any of our directors, officers, or affiliates, or any associate of any such director, officer, affiliate, or security holder is a party adverse to our company or has a material interest adverse to us.
 
ITEM 1A.  RISK FACTORS
 
Not applicable.
 
ITEM 2.  UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
 
None
 
ITEM 3.  DEFAULTS UPON SENIOR SECURITIES
 
None.
 
ITEM 4.  MINE SAFETY DISCLOSURES
 
Not applicable.
 
ITEM 5.  OTHER INFORMATION

None.
 
ITEM 6.  EXHIBITS
  
The following exhibits are included as part of this report:
 
Exhibit No.
 
Description
31.1
 
31.2
 
32.1
 
32.2
 
101.INS
 
XBRL Instance Document
101.SCH
 
XBRL Taxonomy Extension Schema Document
101.CAL
 
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
 
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
 
XBRL Taxonomy Extension Label Linkbase Document
101.PRE
 
XBRL Taxonomy Extension Presentation Linkbase Document
 
SIGNATURES
 
In accordance with the requirements of the Securities Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 

BIO-AMD, INC.
 
 
 
 
 
 
 
 
 
 
November 14, 2016 
By:
/s/ Thomas Barr
 
 
 
Thomas Barr, Chief Executive Officer
 
 
 
 
 
 
 
 
 
November 14, 2016 
 
/s/ David Miller
 
 
 
David Miller, Chief Financial Officer
 
 
 
 
 
 
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