UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C.  20549

 

FORM 10-Q

 

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

For the quarterly period ended March 31, 20172018

OR

¨ 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: 000-55723

 

GUARDION HEALTH SCIENCES, INC.

(Exact name of Registrant as specified in its charter)

 

Delaware 

15150 Avenue of Science, Suite 200

San Diego, California 92128

Telephone: 858-605-9055

 47-4428421

(State or other jurisdiction

of incorporation or

organization)

 (Address and telephone number of principal executive offices) 

(I.R.S. Employer

Identification No.)

 

15150 Avenue of Science, Suite 200

San Diego, California 92128

Telephone: 858-605-9055

(Address and telephone number of principal executive offices)

 

Not applicable

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

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or Section 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.x Yes ¨ 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).x Yes ¨ No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer¨Accelerated filer¨
Non-accelerated filer¨Smaller reporting companyx
   (Do not check if a smaller reporting company)Emerging growth companyx

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act¨ Yes x No

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).¨ Yes x No

 

As of May 10, 2017,11, 2018, there were outstanding 25,443,25940,329,475 shares of the issuer’s common stock issued and outstanding, $0.001 par value. Registrant’s common stock is not yet publicly traded.

 

 

 

  

TABLE OF CONTENTS

 

  Page No.
PART I – FINANCIAL INFORMATION 
   
ITEM 1.CONDENSED CONSOLIDATED FINANCIAL STATEMENTS4
   
 Balance Sheets – As of March 31, 20172018 (Unaudited) and December 31, 201620174
   
 Statements of Operations (Unaudited) – Three Months Ended March 31, 20172018 and March 31, 201620175
   
 Statement of Stockholders’ DeficiencyEquity (Unaudited) – Three Months Ended March 31, 201720186
   
 Statements of Cash Flows (Unaudited) – Three Months Ended March 31, 20172018 and March 31, 201620177
   
 Notes to Condensed Consolidated Financial Statements (Unaudited)8
   
ITEM 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS1719
   
ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK2326
   
ITEM 4.CONTROLS AND PROCEDURES2326
   
PART II – OTHER INFORMATION 
   
ITEM 1.LEGAL PROCEEDINGS2427
   
ITEM 1A.RISK FACTORS2427
   
ITEM 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS2427
   
ITEM 3.DEFAULTS UPON SENIOR SECURITIES2527
   
ITEM 4.MINE SAFETY DISCLOSURES2527
   
ITEM 5.OTHER INFORMATION2527
   
ITEM 6.EXHIBITS2527
   
SIGNATURES 2628

 


Introductory Comment

 

Throughout this Quarterly Report on Form 10-Q, the terms “we,” “us,” “our,” “our company,” “Guardion,” the “Company” and the “Registrant” refer to Guardion Health Sciences, Inc.

 

FORWARD LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q (the(this “Report”) contains forward-looking statements.statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  These statements relate to future events or future predictions, including events or predictions relating to ourthe Company’s future financial performance, and are based on current expectations, estimates, forecasts and projections about us, ourthe Company, its future performance, ourits beliefs and management’s assumptions.  They are generally identifiable by use of the words “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “feel,” “confident,” “estimate,” “intend,” “predict,” “forecast,” “potential” or “continue” or the negative of such terms or other variations on these words or comparable terminology. These statements are only predictions and involve known and unknown risks uncertainties and other factors, including the risks described under “Risk Factors”uncertainties that may cause the Company’sindividually or its industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statements.  In addition to the risks described in Risk Factors, important factors to consider and evaluate in such forward-looking statements include: (i) general economic conditions and changes in the external competitive market factors which might impact the Company’s resultsmatters discussed herein for a variety of operations; (ii) unanticipated working capital or other cash requirements including those created byreasons that are outside the failurecontrol of the Company, including, but not limited to, adequately anticipate the costs associated with acquisitionsCompany’s ability to raise sufficient financing to implement its business plan and other critical activities; (iii) changesits ability to successfully develop and commercialize its proprietary products and technologies. Readers are cautioned not to place undue reliance on these forward-looking statements, as actual results could differ materially from those described in the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company’s corporate strategy or an inability to execute its strategy due to unanticipated changes;recent filings with the U. S. Securities and (iv)Exchange Commission (the “SEC”), including the failure of the Company to complete any or all of the transactions described herein on the terms currently contemplated.  As a result of these risks and uncertainties, many of which are described in greater detail in the Risk Factors discussion in ourCompany’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016 (“Form 10-K”), there can be no assurance that2017 and in other documents the Company files with the SEC from time to time. These filings are available at the SEC’s website (www.sec.gov). The Company disclaims any intention or obligation to update or revise any forward-looking statements, containedwhether as a result of new information, future events or otherwise, in this Report will in fact transpire.each case, except to the extent required by applicable law.

 

Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee future results, levels of activity, performance or achievements.  The Company will not update or revise the forward-looking statements except to the extent required by applicable law.


PART I – FINANCIAL INFORMATION

 

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Guardion Health Sciences, Inc.

Condensed Consolidated Balance Sheets

 

 March 31,  December 31,  March 31,  December 31, 
 2017  2016  2018  2017 
 (Unaudited)    (Unaudited)   
Assets                
                
Current assets                
Cash $444,850  $62,520  $3,198,349  $4,735,230 
Accounts receivable  1,914   1,673   57,426   72,771 
Inventories  50,024   43,999   182,919   154,730 
Current portion of deposits and prepaid expenses  37,732   29,363 
Prepaid expenses  114,678   117,164 
                
Total current assets  534,520   137,555   3,553,372   5,079,895 
                
Deposits and prepaid expenses, less current portion  10,470   10,470 
Deposits  10,470   10,470 
Property and equipment, net  98,474   114,020   171,345   95,597 
Intangible assets, net  617,082   620,741 
Goodwill  1,563,520   1,563,520 
                
Total assets $643,464  $262,045  $5,915,789  $7,370,223 
                
Liabilities and Stockholders’ Deficiency        
Liabilities and Stockholders’ Equity        
                
Current liabilities                
Accounts payable and accrued liabilities $433,549  $356,467  $446,561  $311,236 
Accrued expenses and deferred lease costs  59,835   88,290 
Accrued expenses and deferred rent  16,472   12,043 
Line of credit  -   30,535 
Due to related parties  133,388   91,483   136,968   146,133 
Current portion of convertible notes payable  45,063   44,323 
Current portion of promissory notes payable  125,433   10,251 
Current portion of promissory notes payable related party  -   16,805 
                
Total current liabilities  797,268   607,619   600,001   499,947 
                
Commitments and contingencies                
                
Stockholders’ Deficiency        
Stockholders’ Equity        
                
Series A preferred stock, $0.001 par value; 2,000,000 shares authorized; 1,705,154 and 1,705,154 shares issued and outstanding at March 31, 2017 and December 31, 2016  1,705   1,705 
Series B preferred stock, $0.001 par value; 2,000,000 shares authorized; 700,000 issued and outstanding at March 31, 2017  700   - 
Common stock, $0.001 par value; 90,000,000 shares authorized; 25,268,259 and 25,046,438 shares issued and outstanding at March 31, 2017 and December 31, 2016  25,269   25,046 
Preferred stock, $0.001 par value; 10,000,000 shares authorized  -   - 
Common stock, $0.001 par value; 90,000,000 shares authorized; 40,329,475 and 40,183,475 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively  40,329   40,183 
Additional paid-in capital  21,205,658   20,277,882   34,474,876   33,696,049 
Accumulated deficit  (21,387,136)  (20,650,207)  (29,199,417)  (26,865,956)
                
Total stockholders’ deficiency  (153,804)  (345,574)
Total stockholders’ equity  5,315,788   6,870,276 
                
Total liabilities and stockholders’ deficiency $643,464  $262,045 
Total liabilities and stockholders’ equity $5,915,789  $7,370,223 

 

See accompanying notes to condensed consolidated financial statements.

 

4

 

 

Guardion Health Sciences, Inc.

Condensed Consolidated Statements of Operations

 

 Three Months Ended March 31,  

Three Months Ended

March 31,

 
 2017  2016  2018  2017 
 (Unaudited) (Unaudited)  (Unaudited) (Unaudited) 
Revenue $55,941  $29,134  $193,040  $55,941 
                
Cost of goods sold  22,633   14,247   79,278   22,633 
                
Gross profit  33,308   14,887   113,762   33,308 
                
Operating expenses                
Research and development  10,239   10,172   159,588   10,239 
Sales and marketing  76,736   103,578   605,990   76,736 
General and administrative  598,913   623,956   1,680,810   598,913 
                
Total operating expenses  685,888   737,706   2,446,388   685,888 
                
Loss from operations  (652,580)  (722,819)  (2,332,626)  (652,580)
                
Other expenses:                
Interest expense  16,431   226,384   835   16,431 
                
Total other expenses  16,431   226,384 
        
Net loss  (669,011)  (949,203)  (2,333,461)  (669,011)
                
Adjustments related to Series A and Series B convertible preferred stock:                
Accretion of deemed dividend  (31,841)  -   -   (31,841)
Dividend declared  (36,077)  -   -   (36,077)
Net loss attributable to common shareholders $(736,929) $(949,203) $(2,333,461) $(736,929)
                
Net loss per common share – basic and diluted $(0.03) $(0.05) $(0.06) $(0.03)
Weighted average common shares outstanding – basic and diluted  24,760,327   20,966,396   40,314,875   24,760,327 

 

See accompanying notes to condensed consolidated financial statements.

5


Guardion Health Sciences, Inc.

Condensed Consolidated Statement of Stockholders’ Equity

(Unaudited)

  Common Stock          
  Shares  Amount  

Additional

Paid-In

Capital

  

Accumulated

Deficit

  

Total

Stockholders’

Equity

 
Balance at December 31, 2017  40,183,475  $40,183  $33,696,049  $(26,865,956) $6,870,276 
Fair value of vested stock options  -   -   777,513   -   777,513 
Issuance of common stock – warrant exercises  146,000   146   1,314   -   1,460 
Net loss  -   -   -   (2,333,461)  (2,333,461)
Balance at March 31, 2018  40,329,475  $40,329  $34,474,876  $(29,199,417) $5,315,788 

See accompanying notes to condensed consolidated financial statements.

  


Guardion Health Sciences, Inc.

Condensed Consolidated Statements of Cash Flows

  

Three Months Ended

March 31,

 
  2018  2017 
  (Unaudited)  (Unaudited) 
Operating Activities        
Net loss $(2,333,461) $(669,011)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  73,022   15,545 
Accrued interest expense included in notes payable  -   13,116 
Stock-based compensation  777,513   103,623 
Stock-based compensation – related parties  -   57,158 
Changes in operating assets and liabilities:        
(Increase) decrease in -        
Accounts receivable  15,345   (240)
Inventories  (28,188)  (6,025)
Deposits and prepaid expenses  2,486   (8,369)
Increase (decrease) in -        
Accounts payable and accrued expenses  135,324   77,083 
Accrued and deferred rent costs  4,429   (28,456)
         
Net cash used in operating activities  (1,353,530)  (445,576)
         
Investing Activities        
Purchase of property and equipment  (95,111)  - 
Purchase of intellectual property  (50,000)  - 
         
Net cash used in investing activities  (145,111)  - 
         
Financing Activities        
Proceeds from issuance of promissory notes  -   100,000 
Payments on promissory notes  -   (14,000)
Payments on line of credit  (30,535)  - 
Proceeds from issuance of preferred stock  -   700,000 
Proceeds from exercise of warrants  1,460   - 
(Decrease) increase in due to related parties  (9,165)  41,906 
         
Net cash (used in) provided by financing activities  (38,240)  827,906 
         
Cash:        
Net (decrease) increase  (1,536,881)  382,330 
Balance at beginning of period  4,735,230   62,520 
Balance at end of period $3,198,349  $444,850 

See accompanying notes to condensed consolidated financial statements.

7

 

 

Guardion Health Sciences, Inc.

Condensed Statement of Stockholders’ Deficiency

(Unaudited)

  Series A Preferred Stock  Series B Preferred Stock  Common Stock          
  Shares  Amount  Shares  Amount  Shares  Amount  

Additional

Paid-In

Capital

  

Accumulated

Deficit

  

Total

Stockholders’

Deficiency

 
Balance at December 31, 2016  1,705,154  $1,705   -  $-   25,046,438  $25,046  $20,277,882  $(20,650,207) $(345,574)
Issuance of common stock for services  -   -   -   -   162,500   163   160,618   -   160,781 
Issuance of preferred stock  -   -   700,000   700   -   -   699,300   -   700,000 
Accretion of beneficial conversion feature on preferred stock  -   -   -   -   -   -   31,841   (31,841)  - 
Dividend on preferred stock  -   -   -   -   59,321   60   36,017   (36,077)  - 
Net loss  -   -   -   -   -   -   -   (669,011)  (669,011)
Balance at March 31, 2017  1,705,154  $1,705   700,000  $700   25,268,259  $25,269  $21,205,658  $(21,387,136) $(153,804)

See accompanying notes to condensed financial statements.


Guardion Health Sciences, Inc.

Condensed Statements of Cash Flows

  Three Months Ended March 31, 
  2017  2016 
  (Unaudited)  (Unaudited) 
Operating Activities        
Net loss $(669,011) $(949,203)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  15,545   8,492 
Amortization of debt discount  -   109,455 
Accrued interest expense included in notes payable  13,116   17,148 
Fair value of warrants issued as post-maturity interest  -   99,782 
Stock-based compensation  103,623   8,127 
Stock-based compensation – related parties  57,158   240,892 
Changes in operating assets and liabilities:        
(Increase) decrease in -        
Accounts receivable  (240)  15 
Inventories  (6,025)  (10,465)
Deposits and prepaid expenses  (8,369)  11,361 
Increase (decrease) in -        
Accounts payable and accrued expenses  77,083   122,454 
Accrued and deferred rent costs  (28,456)  (21,920)
         
Net cash used in operating activities  (445,576)  (363,862)
         
Investing Activities        
Purchase of property and equipment  -   (1,171)
         
Net cash used in investing activities  -   (1,171)
         
Financing Activities        
Proceeds from issuance of convertible notes payable  -   136,000 
Proceeds from issuance of promissory notes – related party  -   90,000 
Proceeds from issuance of promissory notes  100,000   25,000 
Payments on promissory notes  (14,000)  - 
Proceeds from issuance of preferred stock  700,000   - 
Increase in due to related parties  41,906   85,300 
         
Net cash provided by financing activities  827,906   336,300 
         
Cash:        
Net increase (decrease)  382,330   (28,733)
Balance at beginning of period  62,520   13,850 
Balance at end of period $444,850  $(14,883)
         
Supplemental disclosure of cash flow information:        
Cash paid for -        
Interest $-  $- 
Income taxes $-  $- 
         
Non-cash financing activities:        
Fair value of warrants issued in connection with promissory and convertible notes payable $-  $124,710 
Beneficial conversion feature associated with promissory and convertible notes payable $-  $39,774 

See accompanying notes to condensed financial statements.

Guardion Health Sciences, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Three Months Ended March 31, 20172018 and 20162017

 

1.Organization and Business Operations

 

Organization and Business

 

Guardion Health Sciences, Inc. (the “Company”) was formed in December 2009 as a California limited liability company under the name P4L Health Sciences, LLC. On June 30, 2015, the Company converted from a California limited liability company to a Delaware corporation, changing its name from Guardion Health Sciences, LLC to Guardion Health Sciences, Inc.

 

The Company is a specialty health sciences company formed to develop, formulate and distribute condition-specific medical foods with an initial medical food product on the market under the brand name Lumega-Z® that replenishes and restores the macular protective pigment.

 

Through March 31,The Company also developed a proprietary medical device called the MapcatSF®that accurately measures the macular pigment optical density.

On September 29, 2017, the Company completed its acquisition of substantially all of the assets and certain liabilities of VectorVision, Inc., a company that specializes in the standardization of contrast sensitivity, glare sensitivity, low contrast acuity, and ETDRS visual acuity testing. VectorVision develops, manufactures and sells equipment and supplies for standardized vision testing.

The Company has had limited operations butto date and has been primarily engaged in research, and development, commercialization and capital raising. The Company has incurred significant expenditures for the development of the Company's products and intellectual property, which includes research and development of both medical foods and medical diagnostic equipment for the treatment of various eye diseases. The Company had limited revenue during the three months ended March 31, 2017 and 2016, all of which was generated by the sale of the Company’s proprietary product, Lumega-Z. In late 2014, the Company changed its focus from the dietary supplement category to the medical food category based on consultation with the Company’s intellectual property counsel and regulatory affairs consultants, as a result of which Lumega-Z is now categorized and sold as a medical food.

 

Going Concern and Liquidity

 

The financial statements have been prepared assuming the Company will continue as a going concern. The Company had a net loss of $669,011$2,333,461 and utilized cash in operating activities of $445,576$1,353,530 during the three months ended March 31, 2017, and had a stockholders’ deficit of $153,804 as of March 31, 2017.2018. The Company expects to continue to incur net losses and negative operating cash flows in the near-term. As a result, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern within one year of the date that the financial statements are issued.

 

The Company’s auditors haveindependent registered public accounting firm has also included explanatory language in their opinion that there is substantial doubt aboutaccompanying the Company’s ability to continue as a going concern.audited financial statements for the year ended December 31, 2017. The Company’s financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the possible inability of the Company to continue as a going concern.

 

The Company will continue to incur significant expenses for continued commercialization activities related to its lead product Lumega-Z, the MapcatSF® medical device, and with respect to efforts to build the Company’s infrastructure.VectorVision products. Development and commercialization of medical foods and medical devices involves a lengthy and complex process. Additionally, the Company’s long-term viability and growth may depend upon the successful development and commercialization of new complementary products other than Lumega-Z and the MapcatSF.or product lines. The Company is continuing attemptsto attempt to raise additional debt and/or equity capital to fund future operations, but there can be no assurances that the Company will be able to secure such additional financing in the amounts necessary to fully fund its operating requirements on acceptable terms or at all. If the Company is unable to access sufficient capital resources on a timely basis, the Company may be forced to reduce or discontinue its technology and product development programs and curtail or cease operations.

 


2.Summary of Significant Accounting Policies

 

Basis of Presentation and Use of Estimates

 

The financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The preparation of the financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

 

Intangible Assets

In connection with the VectorVision transaction, we identified and allocated estimated fair values to intangible assets including goodwill and customer relationships.

In accordance with Accounting Standard Codification (“ASC”) 350 – Intangibles – Goodwill and Other, we determined whether these assets are expected to have indefinite (such as goodwill) or limited useful lives, and for those with limited lives, we established an amortization period and method of amortization. Our goodwill and other intangible assets are subject to periodic impairment testing.

We utilized the services of an independent third-party valuation firm to assist us in identifying intangible assets and in estimating their fair values. The useful lives for our intangible assets other than goodwill were estimated based on Management’s consideration of various factors, including assumptions that market participants might use about sales expectations as well as potential effects of obsolescence, competition, technological progress and the regulatory environment. Because the future pattern in which the economic benefits of these intangible assets may not be reliably determined, amortization expense is generally calculated on a straight-line basis.

Amortization expense for the identifiable intangible assets associated with the VectorVision acquisition is approximately $54,000 per quarter and is included with general and administrative expenses in our Statements of Operations.

Impairment of Long-Lived Assets

The Company reviews long-lived assets, including property and equipment, identifiable intangible assets, and goodwill for impairment at each fiscal year end or when events or changes in circumstances indicate the carrying value of these assets may exceed their current fair values. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the assets. Assets to be disposed of are separately presented in the balance sheet and reported at the lower of the carrying amount or fair value less costs to sell and are no longer depreciated. The Company has not historically recorded any impairment to its long-lived assets. In the future, if events or market conditions affect the estimated fair value to the extent that a long-lived asset is impaired, the Company will adjust the carrying value of these long-lived assets in the period in which the impairment occurs. As of March 31, 2018 and December 31, 2017, the Company had not deemed any long-lived assets as impaired and was not aware of the existence of any indicators of impairment at such dates.

Segment Information

The Company operates and manages its business as one reporting and operating segment, which is the business of developing and commercializing a variety of products that support the detection, intervention and monitoring of a range of eye diseases. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance.

Revenue Recognition

 

The Company’s revenue is comprised of sales of medical foods and dietary supplements to consumers through a direct sales/credit card process. RevenueIn addition, the Company sells medical device equipment and supplies to consumers both in the U.S. and internationally.


In September 2014, the Financial Accounting Standards Board issued Accounting Standards Update No. 2014-09 (ASU No. 2014-09) regarding revenue recognition. The new standard provides authoritative guidance clarifying the principles for recognizing revenue and developing a common revenue standard for U.S. generally accepted accounting principles. The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods and services to customers in an amount that reflects the consideration to which the entity expects to be entitled in the exchange for those goods or services. The ASU became effective January 1, 2018.

Due to the nature of the products sold by the Company, the adoption of the new standard has had no quantitative effect on the financial statements. However, the guidance requires additional disclosures to help readers of financial statements better understand the nature, amount, timing, and uncertainty of revenue that is recognized.

The Company previously recognized revenue when the risk of loss transferstransferred to our customers and collection of the receivable iswas reasonably assured, which generally occurs when the product is shipped. A product is not shipped without an order from the customer and credit acceptance procedures performed.

The Company allows for returns within 30 days of purchase. Productpurchase, although for all periods presented, returns for the three months ended March 31, 2017 and 2016 werehave been insignificant.

 

Under the new guidance, revenue is recognized when control of promised goods or services is transferred to our customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. The Company reviews its sales transactions to identify contractual rights, performance obligations, and transaction prices, including the allocation of prices to separate performance obligations, if applicable. Revenue and costs of sales are recognized once products are delivered to the customer’s control and performance obligations are satisfied.

All products sold by the Company are distinct individual products and consist of medical foods, supplemental formulas, medical devices and related supplies. The products are offered for sale as finished goods only, and there are no performance obligations required post-shipment for customers to derive the expected value from them. Contracts with customers contain no incentives or discounts that could cause revenue to be allocated or adjusted over time.

Control of products we sell transfers to customers upon shipment from our facilities, and the Company’s performance obligations are satisfied at that time. Shipping and handling activities are performed before the customer obtains control of the goods and therefore represent a fulfillment activity rather than a promised service to the customer. Payment for sales of Lumega-Z is generally made by approved credit cards. Payments for medical device sales are generally made by check, credit card, or wire transfer. Historically the Company has not experienced any significant payment delays from customers.

We provide a 30-day right of return to our retail Lumega-Z customers. A right of return does not represent a separate performance obligation, but because customers are allowed to return products, the consideration to which the Company expects to be entitled is variable. Upon evaluation of historical Lumega-Z and VectorVision product returns, the Company determined that less than one percent of product is returned (less than $2,000 in 2017), and therefore believes it is probable that such returns will not cause a significant reversal of revenue in the future. Due to the insignificant amount of historical returns as well as the standalone nature of our products and assessment of performance obligations and transaction pricing for our sales contracts, we do not currently maintain a contract asset or liability balance at this time. We assess our contracts and the reasonableness of our conclusions on a quarterly basis.

The following table presents our revenues disaggregated by product type:

  Three Months Ended March 31, 
  2018  2017 
Lumega-Z and supplements $72,138  $55,941 
VectorVision medical devices and supplies  120,902   - 
  $193,040  $55,941 


Research and Development Costs

 

Research and development costs consist primarily of fees paid to consultants and outside service providers patent fees and costs, and other expenses relating to the acquisition, design, development and testing of the Company’s medical foods and related products. Research and development expenditures, which include patent related costs and stock compensation expense, are expensed as incurred and totaled $10,239$159,588 and $10,172$10,239 for the three months ended March 31, 20172018 and 2016,2017, respectively.

 

Stock-Based Compensation

 

The Company periodically issues stock-based compensation to officers, directors, contractors and consultants for services rendered. Such issuances vest and expire according to terms established at the issuance date.

 

Stock-based payments to officers, and directors, consultants, contractors, and to employees, which include grants of employee stock options, are recognized in the financial statements based on their fair values. Stock option grants, which are generally time vested, will be measured at the grant date fair value and charged to operations on a straight-line basis over the vesting period. The fair value of stock options is determined utilizing the Black-Scholes option-pricing model, which is affected by several variables, including the risk-free interest rate, the expected dividend yield, the expected life of the equity award, the exercise price of the stock option as compared to the fair market value of the common stock on the grant date and the estimated volatility of the common stock over the term of the equity award.

 

The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant. Until the Company has established a trading market for its common stock, estimated volatility is based on the average historical volatilities of comparable public companies in a similar industry. The expected dividend yield is based on the current yield at the grant date. The Company has never declared or paid dividends on its common stock and has no plans to do so for the foreseeable future.

The fair value of common stock was determined based on management’s judgment. In order to assist management in calculating such fair value, the Company retained a third-party valuation firm whose input was utilized in determining the related per unit or share valuations of the Company’s equity instruments. Management used valuations of $1.00 per unit or share in its fair value calculations for the periods between January 1, 2016 and September 30, 2016, and $0.88 per share for periods after September 30, 2016. The current valuation of $0.88 per share is lower than previous valuations due to the dilutive effect of the issuance of common shares as compensation during the periods. There are numerous acceptable ways to estimate company value, including using net tangible assets, a market-based approach, or discounted cash flows. The Company considered alternative methods and concluded that due to the lack of suitably comparable market data, the discounted cash flows method was the most appropriate. A discounted cash flows (i.e. free cash flows to equity) methodology was applied by the third-party valuation firm using multiple years of balance sheet and income statement projections along with the following primary assumptions:


  Three Months Ended March 31, 
  2017  2016 
Discount rate  16%  16%
Risk free rate  2.48%  2.27%
Rate of return  16%  16%
Sustainable growth rate  5%  5%
Company survival probability  65%  63%
Liquidation value $0  $0 

Management considered business and market factors affecting the Company during the three-month periods ended March 31, 2017 and 2016, including capital raising efforts, its proprietary technology, and other factors. Based on this evaluation, management believes that $0.88 and $1.00 per share valuations are appropriate for accounting purposes for the periods ending March 31, 2017 and 2016, respectively.

The Company accounts for stock option and warrant grants issued and vesting to non-employees in accordance with the authoritative guidance of the FASB wherewhereas the value of the stock compensation is based upon the measurement date as determined at either a) the date at which a performance commitment is reached, or b) at the date at which the necessary performance to earn the equity instruments is complete. Non-employee stock-based compensation charges generally are amortized over the vesting period onusing a straight-linegraded vesting basis. In certain circumstances where there are no future performance requirements by the non-employee, grants are immediately vested and the total stock-based compensation charge is recorded in the period of the measurement date.

 

The Company recognizes stock compensation expense, on stock or unit purchases at a price less than fair value, and for fully-vested stock issued to consultants and other service providers, for the excess of fair value of the stock or units over the price paid for the stock or units.

stock. The Company recognizes the fair value of stock-based compensation within its statements of operations with classification depending on the nature of the services rendered. The Company will issue new shares to satisfy stock option exercises.

Income Taxes

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

The Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP. The tax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority as of the reporting date. If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits of the position are recognized. As of March 31, 2017, the Company had not recorded any liability for uncertain tax positions. In subsequent periods, any interest and penalties related to uncertain tax positions will be recognized as a component of income tax expense.

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

 

Net Loss per Share

 

The Company’s computation of basic and diluted net loss per common share is measured as net loss divided by the weighted average common shares outstanding during the respective periods, excluding unvested restricted common stock.stock, if applicable. Shares of restricted stock are included in the basic weighted average number of common shares outstanding from the time they vest. Potential common shares such as from unexercised warrants, options, and shares associated withof common stock issuable upon conversion of convertible debt and convertible preferred stock outstanding that have an anti-dilutive effect are excluded from the calculation of diluted net loss per share. The Company’s basic and diluted net loss per share is the same for all periods presented because all shares of common stock issuable upon exercise of warrants, options, and conversion of convertible debt and convertible preferred stock outstanding are anti-dilutive as they decrease loss per share.

 


The following table sets forth the number of shares excluded from the computation of diluted loss per share, as their inclusion would have been anti-dilutive:

 

 March 31,  March 31, 
 2017  2016  2018  2017 
Warrants  2,983,666   2,251,166   2,837,666   2,983,666 
Options  2,625,000   - 
Estimated shares issuable upon conversion of convertible notes payable  31,250   1,445,811   -   31,250 
Shares issuable upon conversion of convertible preferred stock  3,775,266   -   -   3,775,266 
  6,790,182   3,696,977   5,462,666   6,790,182 

 


Recent Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2014-09 (ASU 2014-09), Revenue from Contracts with Customers. ASU 2014-09 will eliminate transaction- and industry-specific revenue recognition guidance under current GAAP and replace it with a principle based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. ASU 2014-09 also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. Based on the FASB’s Exposure Draft Update issued on April 29, 2015, and approved in July 2015, Revenue from Contracts With Customers (Topic 606): Deferral of the Effective Date, ASU 2014-09 is now effective for reporting periods beginning after December 15, 2017, with early adoption permitted only as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period. Entities will be able to transition to the standard either retrospectively or as a cumulative-effect adjustment as of the date of adoption. The adoption of ASU 2014-09 is not expected to have any impact on the Company’s financial statement presentation or disclosures.

 

In February 2016, the FASB issued Accounting Standards Update No. 2016-02 (ASU 2016-02), Leases (Topic 842). ASU 2016-02 requires a lessee to record a right-of-use asset and a corresponding lease liability, initially measured at the present value of the lease payments, on the balance sheet for all leases with terms longer than 12 months, as well as the disclosure of key information about leasing arrangements. ASU 2016-02 requires recognition in the statement of operations of a single lease cost, calculated so that the cost of the lease is allocated over the lease term, generally on a straight-line basis. ASU 2016-02 requires classification of all cash payments within operating activities in the statement of cash flows. Disclosures are required to provide the amount, timing and uncertainty of cash flows arising from leases. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Early application is permitted. The Company has not yet evaluated the impact of the adoption of ASU 2016-02 on the Company’s financial statement presentation or disclosures.

 

In March 2016,July 2017, the FASB issued Accounting Standards Update No. 2016-09 (ASU 2016-09), Compensation - Stock Compensation2017-11, Earnings Per Share (Topic 718)260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): Improvements(Part I) Accounting for Certain Financial Instruments with Down Round Features; (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception (“ASU 2017-11”). ASU 2017-11 allows companies to Employee Share-Based Payment Accounting.exclude a down round feature when determining whether a financial instrument (or embedded conversion feature) is considered indexed to the entity’s own stock. As a result, financial instruments (or embedded conversion features) with down round features may no longer be required to be accounted for as derivative liabilities. A company will recognize the value of a down round feature only when it is triggered and the strike price has been adjusted downward. For equity-classified freestanding financial instruments, an entity will treat the value of the effect of the down round as a dividend and a reduction of income available to common shareholders in computing basic earnings per share. For convertible instruments with embedded conversion features containing down round provisions, entities will recognize the value of the down round as a beneficial conversion discount to be amortized to earnings. ASU 2016-09 requires, among other things, that all income tax effects of awards be recognized in the statement of operations when the awards vest or are settled. ASU 2016-09 also allows for an employer to repurchase more of an employee's shares than it can today for tax withholding purposes without triggering liability accounting and allows for a policy election to account for forfeitures as they occur. ASU 2016-092017-11 is effective for fiscal years beginning after December 15, 2016, including2018, and interim periods within those fiscal years. Early adoption is permitted for any entitypermitted. The guidance in any interimASU 2017-11 is to be applied using a full or annual period.modified retrospective approach. The adoption of ASU 2016-09 has2017-11 is not hadcurrently expected to have any impact on the Company’s financial statement presentation or disclosures.

 


ManagementThe Company’s management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures.

 

3.3.VectorVision Acquisition

On September 29, 2017, the Company, through a wholly-owned subsidiary, completed the acquisition of substantially all of the assets and certain liabilities of VectorVision, Inc., an Ohio corporation (“VectorVision”), in exchange for 3,050,000 shares of the Company’s common stock, valued at $2,287,500, pursuant to the terms of an Asset Purchase and Reorganization Agreement dated September 29, 2017, which agreement was entered into on an arm’s-length basis. The wholly-owned subsidiary that acquired the business is called VectorVision Ocular Health, Inc., a Delaware corporation, doing business as VectorVision. With respect to the 3,050,000 shares of common stock, 250,000 shares are held back by the Company through November 28, 2019 as security for VectorVision’s indemnification obligations to the Company and the remaining 2,800,000 shares were issued to VectorVision at the closing of the transaction, which were subsequently distributed out to the two VectorVision shareholders in proportion to their shareholdings in VectorVision, per the Agreement. The shares represented approximately 11% of the Company’s issued and outstanding common stock immediately following consummation of the agreement. The shares held back as security are included in our weighted average common shares outstanding for per-share calculations.


VectorVision develops, manufactures and sells equipment and supplies for standardized vision testing for use by eye doctors in clinical trials, for real-world vision evaluation, and industrial vision testing. VectorVision specializes in the standardization of contrast sensitivity, glare sensitivity, low contrast acuity, and ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity testing. VectorVision developed and commercialized its CSV-1000 medical device to conduct contrast sensitivity testing and it developed and commercialized its ESV-3000 medical device to conduct ETDRS visual acuity testing. The patented standardization system provides the practitioner or researcher with the ability to delineate very small changes in visual capability, either as compared to the population or from visit to visit. The Company believes VectorVision’s CSV-1000 device to be the standard of care for clinical trials. The VectorVision transaction expands the Company’s technical portfolio and the Company believes it further establishes the Company’s position at the forefront of early detection, intervention and monitoring of a range of eye diseases.

In accordance with ASC 805, the Company utilized the acquisition method of accounting, whereby the purchase consideration is allocated to specific tangible and intangible assets at their estimated fair values on the date of acquisition. The following table summarizes the allocation of preliminary fair values of the purchase consideration to the assets and liabilities assumed:

  Fair Values 
Common stock consideration $2,287,500 
Liabilities assumed  108,722 
     Total purchase consideration  2,396,222 
     
Cash  (4,895)
Accounts receivable  (50,105)
Inventory  (93,293)
Prepaid assets  (551)
Property and equipment  (9,458)
Intangible assets  (674,400)
Goodwill $1,563,520 

Goodwill is calculated as the excess of the consideration transferred over the net assets recognized and represents the expected revenue and benefits of the combined company.

The following unaudited pro forma financial information gives effect to the Company’s acquisition of VectorVision as if the acquisition had occurred on January 1, 2016 and had been included in the Company’s consolidated statements of operations during the three-month period ended March 31, 2017:

  Three Months Ended March 31, 
  2017 
Pro forma net revenues $245,177 
Pro forma net loss attributable to common shareholders $(736,724)
Pro forma net loss per share $(0.03)

4.Inventories

 

Inventories consisted of the following:

 March 31,  December 31,  March 31, December 31, 
 2017  2016  2018 2017 
Raw materials $43,987  $40,679  $168,361 $133,354 
Finished goods  6,037   3,320   14,558  21,376 
 $50,024  $43,999  $182,919 $154,730 

 


4.5.Property and Equipment, net

 

Property and equipment consisted of the following: 

 March 31,  December 31,  March 31,  December 31, 
 2017  2016  2018  2017 
Leasehold improvements $98,357  $98,357  $98,357  $98,357 
Testing equipment  145,503   145,503   150,603   150,603 
Furniture and fixtures  15,348   15,348   145,411   50,300 
Computer equipment  15,277   15,277   16,464   16,464 
Office equipment  2,694   2,694   8,193   8,193 
  277,179   277,179   419,028   323,917 
Less accumulated depreciation and amortization  (178,705)  (163,159)  (247,683)  (228,320)
 $98,474  $114,020  $171,345  $95,597 

 

For the three months ended March 31, 2018 and 2017, and 2016, depreciation and amortization expense was $15,545$19,363 and $8,492,$15,545, respectively, of which $7,325$7,530 and $5,515$7,325 was included in research and development expense, respectively,$1,500 and $8,220$0 was included in sales and $2,977marketing expense, and $10,333 and $8,220 was included in general and administrative expense, respectively.

 

5.6.Convertible Notes PayableAcquisition of Intellectual Property

 

  March 31,  December 31, 
Year of issuance: 2017  2016 
2010 (due August 2013) $25,000  $25,000 
Accrued interest  20,063   19,323 
Notes payable $45,063  $44,323 

On January 26, 2018, the Company acquired the rights to the trademark GLAUCO-HEALTH as well as the name “International Eye Wellness Institute” (together, the “IP Assets”) from an unrelated party. The purchase included all rights, title, and interest in and to the IP Assets, including (a) the right to register and use the IP Assets; (b) all goodwill associated with the IP Assets; (c) all income, royalties, and damages hereafter due or payable with respect to the IP Assets; (d) all rights to sue for past, present, and future infringements or misappropriations of the IP Assets; and (e) and all other intellectual property rights owned or claimed by the seller or embodied in the IP Assets. In exchange for these rights, the Company paid the seller $50,000 in cash.

 

ASC 350-30-20 defines a defensive intangible asset as an acquired intangible asset in a situation in which an entity does not intend to actively use the asset but intends to hold (lock up) the asset to prevent others from obtaining access to the asset. The Company determined that the acquired intangible asset met the definition of a defensive intangible asset. The Company accounted for the $50,000 payment as an acquired intangible asset as of the closing of the agreement. As the Company can renew the underlying rights to the IP Assets indefinitely at nominal cost, the assets have been classified as a non-amortizable intangible asset on the Company’s balance sheet at March 31, 2018. The Company will evaluate the status of the assets for impairment quarterly.

On January 26, 2018 the Company entered into a consulting agreement with the principal of the seller to assist with the development of the IP Assets and other assets acquired by the Company in the transaction. In July 2010,conjunction with the consulting agreement, the Company issued a stock option on January 26, 2018 to the consultant to purchase a total of 500,000 shares of the common stock of the Company (see Note 8).

7.Related Party Transactions

Due to and from related parties represents unreimbursed expenses and compensation incurred on behalf of, and amounts loaned to the Company by, Michael Favish, the Company’s Chief Executive Officer, as well as other stockholders. The advances are unsecured, non-interest bearing and are due on demand. As of March 31, 2018 and December 31, 2017, the Company had $136,968 and $146,133, respectively, due to related parties.

During the three months ended March 31, 2018, the Company incurred $68,750 of salary expense and paid $44,762 in salary to its CEO, Michael Favish.


8.Stockholders’ Equity

Preferred Stock

Series A

During 2016, the Company sold 1,170,000 shares of the Company's Series A Senior Convertible Preferred Stock (the "Series A Preferred Stock") to various investors. The purchase price of the Series A Preferred Stock was $1.00 per share, for an unsecured convertible noteaggregate purchase price of $1,170,000. In addition, during 2016, the Company issued 535,154 shares of its Series A Preferred Stock with a fair value of $784,888 upon conversion of $535,149 of notes payable and accrued interest. The Series A Preferred Stock had a stated value of $1.00 per share and accrued an annual dividend at the rate of 8% of the stated value, calculated quarterly, paid in shares of common stock at the rate of $0.60 per share.

During the three months ended March 31, 2017, the Company declared dividends of $33,636 on its Series A Preferred Stock which were satisfied in full through the issuance of an aggregate of 56,065 shares of common stock.

Series B

Beginning in March 2017 and through September 30, 2017, the Company sold 3,105,000 shares of the Company's Series B Convertible Preferred Stock (the "Series B Preferred Stock") to various investors. The purchase price of the Series B Preferred Stock was $1.00 per share, for an aggregate purchase price of $3,105,000. The Series B Preferred Stock had a stated value of $1.00 per share and accrued an annual dividend at the rate of 6% of the stated value,calculated quarterly, paid in shares of common stock at the rate of $0.75 per share.

During the three months ended March 31, 2017, the Company declared dividends of $2,441 on its Series B Preferred Stock which were satisfied in full through the issuance of an aggregate of 3,256 shares of common stock.

On November 3, 2017, the Company completed the issuance and sale of an aggregate of 4,347,827 shares of common stock (see below). The completion of the private placement triggered, at the Company's election, the automatic conversion of the preferred stock into shares of common stock. Accordingly, immediately following the completion of the private placement, the Company effected the conversion of all outstanding shares of preferred stock into 6,981,938 shares of common stock (excluding accrued but unpaid dividends) effective November 3, 2017.


Common Stock

On November 3, 2017, the Company completed the issuance and sale of an aggregate of 4,347,827 shares of common stock, par value $0.001 per share, at a purchase price of $1.15 per share. Total gross proceeds were $5,000,001. These shares were sold in a private placement to certain purchasers pursuant to a Stock Purchase Agreement dated as of November 3, 2017. Pursuant to the agreement, the purchasers have customary preemptive rights to participate in future equity and equity-linked issuances by the Company up to the extent necessary to maintain such purchaser’s pro rata ownership percentage in the amountCompany’s securities, subject to customary exceptions. The preemptive rights terminate at the earlier of $25,000. The note carries simple interest at a rate(i) 18 months from the Effective Date, (ii) such time as the Purchasers hold less than five percent (5%) of 12% per annumthe issued and became due and payable on August 1, 2013. The outstanding amounts are convertible intoshares of the Company’s common stock, or (iii) such time as the shares of common stock of the Company at conversion pricesshall become listed or approved for listing on a national securities exchange.

Warrants

A summary of $0.08 per share. This notethe Company’s warrant activity is currently outstanding and past due, and $20,063 of accrued interest is recorded as of March 31, 2017.follows: 

 

 6.Promissory NotesShares
December 31, 20172,983,666
Granted-
Forfeitures-
Exercised(146,000)
March 31, 2018, all exercisable2,837,666

 

  March 31,  December 31, 
Year of issuance: 2017  2016 
(a) 2016 (due November 2016) $10,000  $10,000 
(b) 2017 (due May 2017)  100,000   - 
Accrued interest  15,433   251 
Promissory notes payable, net $125,433  $10,251 

In January 2018, an investor exercised warrants for 146,000 shares of common stock. The warrants were exercisable for $0.01 per share, and the Company received $1,460 in cash. The Company issued the shares and recorded the cash received as additional equity.


 

(a) In 2016, the Company issued $170,000 of promissory notes to various outside investors, with simple interest rates ranging from 4% - 9% and a weighted average term at issuance of approximately three months. As of March 31, 2018, the Company had an aggregate of 2,837,666 outstanding warrants to purchase shares of its common stock with a weighted average exercise price of $0.37, weighted average remaining life of 0.9 years and aggregate intrinsic value of $1,932,661, based upon a stock valuation of $1.15 per share. The intrinsic value is calculated as the difference between the market value of the underlying common stock and the exercise price of the warrants.

Stock Options

A summary of the Company’s stock option activity is as follows:

Shares
December 31, 20172,125,000
Granted500,000
Forfeitures-
Exercised-
March 31, 2018, all exercisable2,625,000


On September 30, 2017, the Company entered into a consulting agreement pursuant to which the Company issued a total of 1,250,000 common stock options. 650,000 of the options with a fair value of $486,070 vested immediately, and the remaining 600,000 options will vest ratably over the next twelve months on a quarterly basis, with compensation cost to be measured as of the fair value at the end of each reporting period. The options are non-qualified, have an exercise price of $1.00 per share, and will expire after 5 years. As of December 31, 2016,2017, the Company had recognized compensation cost of $658,383 relating to the vesting of the 800,000 options. As of March 31, 2018, the remaining 450,000 options to vest were valued at $517,127 based upon a $10,000 note remainedBlack-Scholes option-pricing model. During the three months ended March 31, 2018, the Company recognized stock compensation costs of $165,449 related to the amortization of these options based upon a graded vesting schedule.

On December 30, 2017, the Company entered into a consulting agreement pursuant to which the Company issued a total of 750,000 common stock options. 250,000 of the options with a fair value of $312,275 vested immediately and the remaining will vest ratably over the next six months on a quarterly basis. The options are non-qualified, have an exercise price of $1.25 per share, and will expire after 5 years. As of March 31, 2018, the remaining 500,000 options to vest were valued at $574,655 based upon a Black-Scholes option-pricing model. During the three months ended March 31, 2018, the Company recognized stock compensation costs of $303,782 related to the amortization of these options based upon a graded vesting schedule.

On January 26, 2018, the Company entered into an agreement with a consultant to develop products based on certain intellectual property owned by the Company (see Note 6). In conjunction with the consulting agreement, the Company issued a stock option to the consultant to purchase a total of 500,000 shares of the common stock of the Company. 250,000 shares of the option with a fair value of $287,500 vested immediately, 125,000 shares vest on December 31, 2018 and the remaining 125,000 shares vest on December 31, 2019 provided the consultant is still an active service provider. The options are non-qualified, have an exercise price of $1.25 per share, and will expire after 5 years. As of March 31, 2018, the 250,000 options that remain to vest were valued in total at $287,500 based upon a Black-Scholes option-pricing model. During the three months ended March 31, 2018, the Company recognized stock compensation costs of $20,782 related to the amortization of these options based upon a graded vesting schedule.

As of March 31, 2018, the options were valued based upon the Black-Scholes option-pricing model, with a stock price of $1.15 volatility of 127%, and an average risk-free rate of 2.37.

As of March 31, 2018, the Company had an aggregate of 800,000 remaining unvested options outstanding, and was past due, and $350 and $251with unamortized compensation of accrued interest is recorded$505,951 that will be amortized in future periods. The aggregate intrinsic value of options outstanding as of March 31, 2017 and December 31, 2016.2018 was $187,500.

(b) In January 2017, the Company issued a $100,000 unsecured promissory note to an outside investor, with a term of 120 days and a fixed interest charge consisting of 6% of the principal in cash plus 6% of the principal in shares of common stock at a price of $0.75 per share, or 8,000 shares. Because the interest charge is fixed and due in full at any repayment date regardless of the stated maturity date, the Company recorded accrued interest of $13,040, representing the total fair value of the charge, at the inception of the note.

 

7.Promissory Notes – Related Party

  March 31,  December 31, 
Year of issuance: 2017  2016 
2016 (due September 2016) $-  $14,000 
Accrued interest  -   2,805 
Promissory notes payable – related party, net $-  $16,805 

In 2016, the Company issued $140,000 of unsecured promissory notes to various related party investors, with interest rates ranging from 6% to 12% and a weighted average term at issuance of approximately four months. As of December 31, 2016 the remaining balance of the unpaid notes was $14,000, which was repaid during the first quarter of 2017.

8.9.Commitments and Contingencies

 

The Company is periodically the subject of various pending or threatened legal actions and claims arising out of its operations in the normal course of business. In the opinion of management of the Company, adequate provision has been made in the Company’s condensed financial statements at March 31, 20172018 with respect to such matters, including the matter noted below.

 

TheOn or about July 26, 2017, the Company recently received a payment demand from a former consultant to the Company alleging that hethe consultant is owed $102,000approximately $192,000 for unpaid services rendered. The Company is evaluating the claimhas disputed this demand and intendsattempts to respond to the former consultant’s demand in due course. Ifresolve this matter results inwere unsuccessful. On January 29, 2018, the filing ofCompany filed a lawsuit against the Company,consultant and its related entities in the United States District Court for the Southern District of California (Case No. 18CV200-W-KSC) seeking declaratory relief regarding advisory fees and ownership interest in the Company. On March 6, 2018, the consultant and its related entities filed counterclaims against the Company, intends to vigorously defend itselfseeking payment for services rendered and seeking declaratory relief regarding ownership interest in the Company. The Company cannot predict the outcome of this matter and believes it has provided appropriate provision for any settlement of this matter as well, will consider filing a counterclaim for damages against the former consultant.of March 31, 2018.

 


9.10.Stockholders’ DeficitSubsequent Events

 

Preferred Stock

Series A

During 2016,On April 26, 2018, the Company sold 1,170,000 sharesfiled a Certificate of the Company’sElimination of Designations, Preferences and Rights of Series A Senior Convertible Preferred Stock to various investors. The purchase price of the stock was $1.00 per share, for an aggregate purchase price of $1,170,000. In addition, the Company issued 535,154 shares of its preferred stock with a fair value of $784,888 upon conversion of $535,149 of notes payable and accrued interest. The stock has a stated value of $1.00 per share and accrues an annual dividend at the rate of 8% of the stated value, calculated quarterly, to be paid in shares of common stock at the rate of $0.60 per share. Dividends are payable to holders of record quarterly, on the last business day of each calendar quarter, from the date of issuance, as may be declared by the Board of Directors, and are cumulative.

At the option of the holder, the Series A preferred stock (including accrued but unpaid dividends) may be converted into shares of the Company’s common stock commencing January 1, 2017 at $0.60 per share. The preferred stock (including accrued but unpaid dividends) shall automatically convert into shares of common stock in the event that the Company receives gross proceeds of at least $4,000,000 in one or more equity financing transactions subsequent to September 30, 2016, or if the ten (10) day Volume Weighted Average Price per share of common stock is $2.00 or more. If not converted by September 30, 2019, the preferred stock (including accrued but unpaid dividends) shall automatically and mandatorily convert into shares of common stock at $0.60 per share. Such mandatory conversion shall be subject to either a registration statement having been filed with the Securities and Exchange Commission, including the common stock underlying the preferred stock, and being in effect, or all shares of underlying common stock being saleable under Rule 144 pursuant to the Securities Act without regard to volume limitations.


The issuance of the 1,170,000 shares of convertible preferred stock gave rise to a beneficial conversion feature due to the stated conversion price of $0.60 per share being less than the market price of the shares at the issuance date as determined by a third-party valuation. The Company accounted for the beneficial conversion features in accordance with ASC 470-20, Accounting for Debt with Conversion and Other Options. The Company calculated a total deemed dividend on the Series A Senior Convertible Preferred Stock of $779,586 at December 31, 2016, which equals the amount by which the estimated fair value of the common stock issuable upon conversion of the issued preferred stock exceeded the proceeds from such issuances. The deemed dividend on the preferred stock is accreted using the effective interest method from the respective issuance dates through the earliest conversion date of January 1, 2017. The accretion of the deemed dividend for the year ended December 31, 2016 was $760,011. The remaining balance of $19,575, representing the amount allocable to the January 1, 2017 earliest conversion date, was accreted in January 2017.

Sale of the Company’s Series A Senior Convertible Preferred Stock was closed on December 31, 2016.

During the three months ended March 31, 2017 the Company declared dividends of $ 33,631 to its Series A preferred shareholders which were paid through the issuance of 56,065 shares of common stock.

Series B

As of May 10, 2017, the Company had sold 700,000 shares of the Company’s Series B Convertible Preferred Stock to various investors.(the "Certificate of Elimination") with the Delaware Secretary of State. The purchase priceCertificate of Elimination eliminates the Company's Series A Preferred Stock and the Company's Series B Preferred Stock from the Company's certificate of incorporation. No shares of the stock was $1.00 per share, for an aggregate purchase price of $700,000. The stock has a stated value of $1.00 per share and accrues an annual dividendSeries A Preferred Stock or Series B Preferred Stock were outstanding at the rate of 6%time of the stated value, calculated quarterly, to be paid in sharesfiling of common stock at the rate of $0.75 per share. Series B preferred stock is convertible commencing December 31, 2017, or earlier upon the approval of the Board of Directors, by the holder into common stock at $0.75 per share. The stock is automatically convertible by the Company upon an equity financing of at least $5,000,000 subsequent to June 30, 2017, or is publicly traded for at least $2.00 per share for 10 consecutive trading days, or upon completion of a Major Transaction (as defined in the Certificate of Designation). Dividends are payable to holders of record quarterly, on the last business day of each calendar quarter, from the date of issuance, as may be declared by the Board of Directors, and are cumulative. Series B preferred stock is senior to all Common Stock and junior to the Series A preferred stock.Elimination.

 

The issuance of the Series B preferred stock gave rise to a beneficial conversion feature due to the stated conversion price of $0.75 per share being less than the market price of the shares at the issuance date. In addition, warrants were issued to investors who had previously participated in the 2016 Series A preferred stock offering.On April 30, 2018, The Company accounted for the beneficial conversion feature, including an allocation of proceeds for theoffered a one-month exercise period extension to stockholders who held warrants on a relative fair value basis, in accordance with ASC 470-20, Accounting for Debt with Conversion and Other Options. The Company calculated a total deemed dividend on the Series B preferred stock of $165,506 at March 31, 2017, which equals the amount by which the estimated fair value of the common stock issuable upon conversion of the issued preferred stock exceeded the proceeds from such issuances. The deemed dividend on the preferred stock is accreted using the effective interest method from the respective issuance dates through the earliest conversion date of December 31, 2017. The accretion of the deemed dividend for the three months ended March 31, 2017 was $12,266.

During the three months ended March 31, 2017, the Company declared dividends of $2,441 to its Series B preferred shareholders which were paid through the issuance of 3,256 shares of common stock.

Both classes of preferred stock will vote with the common stock on an “as converted” basis and have standard anti-dilution rights, exclusive of price protection. Upon any liquidation, dissolution or winding-up of the Company, whether voluntary or involuntary, no distribution shall be made to the holders of anypurchase shares of common stock of the Company unless, prior thereto,that were scheduled to expire on May 1, 2018. Pursuant to the holdersterms of all classes of preferred stock shall have received out of the available assets ofa Note and Warrant Purchase Agreement entered into by the Company whether capital or surplus,and such holders, such warrants were issued upon the conversion of certain promissory notes into common stock on May 1, 2015. Six warrant holders elected to extend the term of an amount equalaggregate of 403,085 warrants by one month to 100%June 1, 2018. The exercise price of the stated value, plus any accrued and unpaid dividends thereon. If the assets of the Company are insufficient to pay in full such amounts due the holders of the preferred stock, then the entire assets shall be distributed ratably among the holders of the preferred stock in accordance with the respective preferences and amounts that would be payable on such shares of preferred stock if all amounts payable thereon were paid in full.warrants is $1.00 per share.

 


Preferred shareholders of both series have unlimited piggyback registration rights. Holders of a majority of the shares of preferred stock (based on the $1.00 stated value) outstanding shall have the right to one demand registration during the three (3) years following the effective date of the Company’s registration statement under the Securities Exchange Act of 1934, so long as at least $500,000 of preferred stock was sold of that series, and at least $250,000 of the related class of preferred stock is still outstanding. This demand registration right will terminate when all shares of preferred stock have been converted into common stock.

In the event of a merger or acquisition or change in control of the Company, the preferred stock (including all accrued but unpaid dividends) will be deemed converted into shares of common stock immediately prior to the closing of such a transaction.

Common Stock

During 2016 and prior, the Company issued 2,005,000 shares of restricted common stock for services rendered. These shares are subject to vesting requirements over 9 to 12 months and remain subject to forfeiture if vesting conditions are not met. The aggregate fair value of the stock was $2,146,280. As of December 31, 2016, 1,652,500 of those shares with a fair value of $2,037,014 had vested, and 352,500 shares with a fair value of $109,266 remained to be vested.

During the three months ended March 31, 2017, the Company issued 162,500 shares of restricted common stock to a service provider. These shares are subject to vesting requirements over 4 months and remain subject to forfeiture if vesting conditions are not met. The aggregate fair value of the stock was $143,000 based on a valuation per share of $0.88 on the date of grant.

During the three months ended March 31, 2017, the Company recorded $1,160,781 of expense related to the vested portion of this restricted stock, and the remaining $91,485 is expected to be recorded in the second quarter of 2017.

Additional details of the Company’s restricted common stock are as follows:

  Number of Shares  Weighted Average
Grant Date Fair Value
Per Share
 
Non-vested, December 31, 2016  352,500   1.13 
Issued  162,500   0.88 
Vested  (123,750)  0.92 
Forfeited  -   - 
Non-vested, March 31, 2017  391,250  $1.09 

Warrants

During the three months ended March 31, 2017, in connection with the Series B Convertible Preferred Stock offering discussed above, the Company issued a total of 60,000 warrants as additional incentive to investors who had previously invested in the Company’s Series A Senior Convertible Preferred Stock offering in 2016. These warrants are fully vested, are immediately exercisable at $0.75 per share, and expire between March 6, 2020 and March 8, 2020. The warrants were valued at $51,796, based upon the Black-Scholes option-pricing model, with a stock price of $0.88, volatility of 135%, and an average risk-free interest rate of 1.61%.

15 

A summary of the Company’s warrant activity is as follows: 

Shares
December 31, 20162,923,666
Granted60,000
Forfeitures-
Exercised-
March 31, 2017, all exercisable2,983,666

As of March 31, 2017, the Company had an aggregate of 2,983,666 outstanding warrants to purchase shares of its common stock with a weighted average exercise price of $0.37, weighted average remaining life of 1.4 years and aggregate intrinsic value of $1,293,512, based upon a stock valuation of $0.88 per share. The intrinsic value is calculated as the difference between the market value of the underlying common stock and the exercise price of the warrants.

10.Related Party Transactions

Due to and from related parties represents unreimbursed expenses and compensation incurred on behalf of, and amounts loaned to the Company by, Michael Favish, the Company’s Chief Executive Officer, as well as other shareholders. The advances are unsecured, non-interest bearing and are due on demand. As of March 31, 2017 and December 31, 2016, the Company had $133,388 and $91,483, respectively, due to related parties.

During the three months ended March 31, 2017, the Company incurred $62,500 of salary expense and paid $22,500 for our CEO, Michael Favish. During the twelve-month period ended December 31, 2016, the Company incurred salary expense of $250,000 and paid $48,500. Accrued amounts are included in general and administrative expenses.

11.Subsequent Events

During April 2017, the Company issued 175,000 shares of fully vested restricted common stock to consultants for services rendered.


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

 

Presentation of Information

 

As used in this Quarterly Report on Form 10-Q, the terms “we,” “us” “our” and the “Company” mean Guardion Health Sciences, Inc. unless the context requires otherwise. The following discussion and analysis should be read in conjunction with our audited financial statements and the related notes that appear elsewhere in this report.report and our audited financing statements for the year ended December 31, 2017, and the notes thereto, which are set forth in the 2017 Form 10-K. All dollar amounts refer to U.S. dollars unless otherwise indicated.

 

Overview

 

Guardion Health Sciences, Inc. was formed in December 2009 in California as a limited liability company under the name P4L Health Sciences, LLC and we subsequently changed our name to Guardion Health Sciences, LLC. On June 30, 2015, we converted from a California limited liability company to a Delaware corporation, changing our name to Guardion Health Sciences, Inc.

 

We are a specialty health sciences company formed to develop, formulate and distribute condition-specific medical foods with an initial medical food product on the market under the brand name Lumega-Z® that replenishes and restores the macular protective pigment. A depleted macular protective pigment is a modifiable risk factor for retina basedretina-based diseases such as age-related macular degeneration (“AMD”), computer vision syndrome (“CVS”) and diabetic retinopathy. Additional research has also shown a depleted macular protective pigment to be a biomarker for neurodegenerative diseases such as Alzheimer’s and dementia. We have had limited commercial operations to date, and have primarily been engaged in research, product development, commercialization and development.capital raising.

 

We have also developed a proprietary medical device called the MapcatSF®that accurately measures the macular pigment optical density (“MPOD”). We invented our own proprietary patented technology embodied in the MapcatSF. On November 8, 2016, the USPTO issued patent number 9,486,136 for the MapcatSF invention. Using the MapcatSF to measure the MPOD allows one to monitor the increase in the density of the macular protective pigment after taking Lumega-Z. The MapcatSF is a non-mydriatic, non-invasive device that is designed to accurately measuresmeasure the MPOD, the lens optical density and lens equivalent age, thereby creating an evidence-based protocol that is shared with the patient. A non-mydriatic device is one that does not require dilation of the pupil for it to function. The MapcatSF is intended to be the first device using a patented “single fixation” process and “automatic lens density correction” that produces accurate serialized data.

 

Lumega-Z has a patent-pending formula that replenishes and restores the macular protective pigment simultaneously delivering critical and essential nutrients to the eye. Formulated by Dr. Sheldon Hendler in 2010, modifications were made over a two-year period to improve the taste and method of delivery. We believe that there is an increasing level of acceptance of medical foods as a primary therapy by patients and healthcare providers to treat pain syndromes, sleep and cognitive disorders, obesity, hypertension, and viral infection. In clinical practice, medical foods are being prescribed as both a standalone therapy and as an adjunct therapy to low doses of commonly prescribed drugs. We believe that medical foods will continue to grow in importance over the coming years.

 


By combining our MapcatSF medical deviceIn September 2017, the Company, through its wholly-owned subsidiary VectorVision Ocular Health, Inc., acquired substantially all the assets and Lumega-Z medical food, we have developed, based on Management’s knowledgecertain liabilities of the industry, the only reliable two-pronged, evidence-based protocol for replenishing and restoring the macular protective pigment and increasing overall retinal health.

Recent Developments

On March 1, 2017, we entered into a non-binding letter of intent (“LOI”) with VectorVision, Inc., a Delaware corporation (“VectorVision”), whereby the parties set forth an outline of the terms and conditions pursuant to which we would acquire all of the outstanding shares of stock of VectorVision in exchange for a to be determined number of shares of our common stock. VectorVisioncompany that specializes in the standardization of contrast sensitivity, glare sensitivity, low contrast acuity, and ETDRSearly treatment diabetic retinopathy study (“ETDRS”) visual acuity vision testing. Its patentedVectorVision’s standardization system providesis designed to provide the practitioner or researcher with the ability to delineate very small changes in visual capability, either as compared to the population or from visit to visit. VectorVision’s CSV-1000 device is consideredVectorVision develops, manufactures and sells equipment and supplies for standardized vision testing for use by eye doctors in clinical trials, for real-world vision evaluation, and industrial vision testing. The acquisition expands the standard of care for clinical trials. Upon closing of the transaction, VectorVision would become a wholly-owned subsidiary of ours. We believe the acquisition of VectorVision would expand ourCompany’s technical portfolio and the Company believes it further establish ourestablishes its position at the forefront of early detection, intervention and monitoring of a range of eye diseases.

By combining the MapcatSF medical device, the newly acquired VectorVision standardized vision testing technology and Lumega-Z medical food, the Company has developed, based on Management’s knowledge of the industry, what it believes to be the only reliable three-pronged, evidence-based protocol for replenishing and restoring the macular protective pigment, increasing overall retinal health and measuring the related improvements in visual function.

Recent Developments

Development of Sales Force

The transaction is subjectCompany invested in a direct sales force in March 2017 comprised of a field-based team of account managers located in key geographical locations based on high population density areas with demographics that match the Company’s target markets. Each account manager will have responsibility for a pre-defined geographical area and will be expected to significant conditions precedenttravel extensively to support the needs of customers. The account managers will be tasked with prospecting for new accounts, closing leads generated by the Company’s marketing efforts, and generating revenue through account management activities including but not limitedphysician and staff training, and implementation of patient education resources. The account managers will also participate in national and regional trade shows and events, including supporting professional optometric and ophthalmological societies at a State level. Each account manager will be tasked with a quota that includes units of Lumega-Z sold, as well as sales of the MapcatSF, CSV-1000 and ESV-3000. Commissions are based on sales performance and achievement of quota.

Patents

On March 14, 2018, the Company received a Notice of Allowance on Patent Application 15/445,586, which describes a methodology to continuously calibrate display monitors to automatically hold display luminance constant for vision testing. The VectorVision CSV-1000 and ESV-3000 devices each embody this invention. The Company expects this patent to issue shortly.

Prior to the satisfactory completionissuance of due diligence,US Patent No. 9,486,136, the determinationCompany filed a continuation application, Patent Application 15/346,010, covering new embodiments around the MapcatSF® device. These new embodiments contain improvements related to the accuracy of intensity measurements made with the amount of purchase consideration, the negotiation of definitive transaction documents, the completion of an audit of VectorVision’s financial statements, and other matters, no later than the June 30, 2017 expiration date of the LOI.device, as well as updated features around photodiode detector calibrations.

 


Going Concern

 

The financial statements have been prepared assuming wethe Company will continue as a going concern. We haveThe Company had a net loss of $2,333,461 and utilized cash in operating activities of $445,576 and $363,862$1,353,530 during the three months ended March 31, 2017 and 2016, respectively, and had a total stockholders’ deficiency of $153,804 and $345,574 as of March 31, 2017 and December 31, 2016, respectively. We expect2018. The Company expects to continue to incur net losses and negative operating cash flows in the near-term. As a result, management has concluded that there is substantial doubt about ourthe Company’s ability to continue as a going concern within one year of the date that the financial statements are issued.

 

Our auditors haveThe Company’s independent registered public accounting firm has also included explanatory language in their opinion that there is substantial doubt about our ability to continue as a going concern.accompanying the Company’s audited financial statements for the year ended December 31, 2017. The Company’s financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the possible inability of usthe Company to continue as a going concern.

 


WeThe Company will continue to incur significant expenses for continued commercialization activities related to our lead product Lumega-Z, the MapcatSF® medical device, and with respect to efforts to build our infrastructure.VectorVision products. Development and commercialization of medical foods and medical devices involves a lengthy and complex process. Additionally, ourthe Company’s long-term viability and growth may depend upon the successful development and commercialization of new complementary products other than Lumega-Z and the MapcatSF. We areor product lines. The Company is continuing attemptsto attempt to raise additional debt and/or equity capital to fund future operations, but there can be no assurances that wethe Company will be able to secure such additional financing in the amounts necessary to fully fund ourits operating requirements on acceptable terms or at all. If we arethe Company is unable to access sufficient capital resources on a timely basis, wethe Company may be forced to reduce or discontinue ourits technology and product development programs and curtail or cease operations.

 

Recent Accounting Pronouncements

 

See Note 12 to the condensed consolidated financial statements for Managements’managements’ discussion of recent accounting pronouncements.

 

Critical Accounting Policies and Estimates

 

Our financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The preparation of theour financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Our financial statements included herein include all adjustments, consisting of only normal recurring adjustments, necessary to present fairly our financial position, results of operations and cash flows.

 

The following critical accounting policies affect the more significant judgments and estimates used in the preparation of our financial statements.

 

Intangible Assets

In connection with the VectorVision transaction, we identified and allocated estimated fair values to intangible assets including goodwill and customer relationships.

In accordance with Accounting Standard Codification (“ASC”) 350 – Intangibles – Goodwill and Other, we determined whether these assets are expected to have indefinite (such as goodwill) or limited useful lives, and for those with limited lives, we established an amortization period and method of amortization. Our goodwill and other intangible assets are subject to periodic impairment testing.

We utilized the services of an independent third-party valuation firm to assist us in identifying intangible assets and in estimating their fair values. The useful lives for our intangible assets other than goodwill were estimated based on Management’s consideration of various factors, including assumptions that market participants might use about sales expectations as well as potential effects of obsolescence, competition, technological progress and the regulatory environment. Because the future pattern in which the economic benefits of these intangible assets may not be reliably determined, amortization expense is generally calculated on a straight-line basis.

Impairment of Long-Lived Assets

The Company reviews long-lived assets, including property and equipment, identifiable intangible assets, and goodwill for impairment at each fiscal year end or when events or changes in circumstances indicate the carrying value of these assets may exceed their current fair values. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the assets. Assets to be disposed of are separately presented in the balance sheet and reported at the lower of the carrying amount or fair value less costs to sell and are no longer depreciated. The Company has not historically recorded any impairment to its long-lived assets. In the future, if events or market conditions affect the estimated fair value to the extent that a long-lived asset is impaired, the Company will adjust the carrying value of these long-lived assets in the period in which the impairment occurs. As of March 31, 2018 and December 31, 2017, the Company had not deemed any long-lived assets as impaired and was not aware of the existence of any indicators of impairment at such dates.


Stock-Based Compensation

 

WeThe Company periodically issueissues stock-based compensation to officers, directors, contractors and other consultants for services rendered. Such issuances vest and expire according to terms established at the issuance date.

 

Stock-based payments to officers, directors, consultants, contractors, and directors, and to employees, in the future which will include grants of employee stock options, are recognized in the financial statements based on their fair values. Stock option grants, which are generally time vested, will be measured at the grant date fair value and charged to operations on a straight-line basis over the vesting period. The fair value of stock options is determined utilizing the Black-Scholes option-pricing model, which is affected by several variables, including the risk-free interest rate, the expected dividend yield, the expected life of the equity award, the exercise price of the stock option as compared to the fair market value of the common stock on the grant date and the estimated volatility of the common stock over the term of the equity award.

 


The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant. Until we have established a trading market for our common stock, estimated volatility is based on the average historical volatilities of comparable public companies in a similar industry. The expected dividend yield is based on the current yield at the grant date; we have never declared or paid dividends on our common stock and have no plans to do so for the foreseeable future.

The fair value of common stock was determined based on management’s judgment. In order to assist management in calculating such fair value, we retained a third-party valuation firm in determining the value of our Company. The third-party valuation firm’s input was utilized in determining the related per unit or share valuations of our equity used at March 31, 2017 and December 31, 2016. Management used valuations of $1.00 per unit or share in its fair value calculations for the periods between January 1, 2016 and September 30, 2016, and $0.88 per share for periods after September 30, 2016, based on various inputs, including valuation reports prepared by the third-party valuation firm as of December 31, 2016 and 2015. The fully diluted per share equivalent price is lower in 2017 than in early 2016 due to the dilutive effect of the issuance of common shares as compensation during the period. There are numerous acceptable ways to estimate company value, including using net tangible assets, a market-based approach, or discounted cash flows. We considered alternative methods and concluded that due to the lack of suitably comparable market data, the discounted cash flows method was the most appropriate. A discounted cash flows (i.e. free cash flows to equity) methodology was applied by the third-party valuation firm using multiple years of balance sheet and income statement projections along with the following primary assumptions:

  Three Months Ended March 31, 
  2017  2016 
Discount rate  16%  16%
Risk free rate  2.48%  2.27%
Rate of return  16%  16%
Sustainable growth rate  5%  5%
Company survival probability  65%  63%
Liquidation value $0  $0 

Management considered business and market factors affecting us during the three-month periods ended March 31, 2017 and 2016, including capital raising efforts, its proprietary technology, and other factors. Based on this evaluation, management believes that $0.88 and $1.00 per share valuations are appropriate for accounting purposes at March 31, 2017 and December 31, 2016.

We accountCompany accounts for stock option and warrant grants issued and vesting to non-employees in accordance with the authoritative guidance of the FASB whereas the value of the stock compensation is based upon the measurement date as determined at either a) the date at which a performance commitment is reached, or b) at the date at which the necessary performance to earn the equity instruments is complete. Non-employee stock-based compensation charges generally are amortized over the vesting period onusing a straight-linegraded vesting basis. In certain circumstances where there are no future performance requirements by the non-employee, grants are immediately vested and the total stock-based compensation charge is recorded in the period of the measurement date.

 

We recognizeThe risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant. Until the Company has established a trading market for its common stock, estimated volatility is based on the average historical volatilities of comparable public companies in a similar industry. The expected dividend yield is based on the current yield at the grant date. The Company has never declared or paid dividends on its common stock and has no plans to do so for the foreseeable future.

The fair value of common stock was determined based on management’s judgment. In order to assist management in calculating such fair value, we retained a third-party valuation firm in determining the value of our Company. The third-party valuation firm’s input was utilized in determining the related per unit or share valuations of our equity used during 2017. Management used a valuation of $0.88 per share for the first quarter of 2017. Internal valuations are based on various inputs, including valuation reports prepared by third-party valuation firms and are impacted by the dilutive effect of the issuance of common shares as compensation during the periods. There are numerous acceptable ways to estimate company value, including using net tangible assets, a market-based approach, or discounted cash flows. The Company considered alternative methods and concluded that due to the lack of suitably comparable market data, the discounted cash flows method was the most appropriate. A discounted cash flows (i.e. free cash flows to equity) methodology was applied by the third-party valuation firm to assist management in their determination of the $0.88 used during 2017. This methodology used multiple years of balance sheet and income statement projections along with the following primary assumptions:

  Three Months Ended March 31, 
  2018  2017 
Discount rate  -%  16%
Risk free rate  -%  2.48%
Rate of return  -%  16%
Sustainable growth rate  -%  5%
Company survival probability  -%  65%
Liquidation value $-  $0 

Due to the availability of historical data from the Company’s recent common stock sales, Management used a valuation of $1.15 for the first quarter of 2018. Management considered business and market factors affecting the Company during the three-month periods ended March 31, 2018 and 2017, including capital raising efforts, its proprietary technology, and other factors. Based on this evaluation, management believes that $1.15 and $0.88 per share valuations are appropriate for accounting purposes at March 31, 2018 and 2017.


The Company recognizes stock compensation expense, on stock or unit purchases at a price less than fair value, and for fully-vested stock issued to consultants and other service providers, for the excess of fair value of the stock or units over the price paid for the stock or units.

We recognizestock. The Company recognizes the fair value of stock-based compensation within ourits statements of operations with classification depending on the nature of the services rendered. WeThe Company will issue new shares to satisfy stock option exercises.

 

During the three months ended March 31, 2017 and 2016, we recognized aggregate stock-compensation expense of $160,781 and $249,019, respectively, based upon stock prices ranging from $0.88 to $1.14 per share, of which $150,288 and $199,146 was recorded in general and administrative expense, $10,179 and $48,178 was recorded in sales and marketing expense, and $314 and $1,695 was recorded in research and development expense, respectively.


Plan of Operations

 

General Overview

 

Based on the availability of sufficient funding, we intend to increase our commercialization activities and:

 

 ·furtherFurther the commercial production of our MapcatSF, starting with the manufacture of at least ten new units for sale or lease to our customers and for use in our internal clinics;

 ·expandExpand our domestic sales and marketing efforts, which include revamping our web site and new promotional materials;

 ·increaseExplore sales and marketing opportunities in foreign markets such as Asia and Europe;
·Increase production of Lumega-Z as is necessary to support the additional sales resulting from the deployment of additional MapcatSF units and increased marketing and promotional activity;

 ·commenceCommence certain FDA electrical safety testing of the MapcatSF; and

 ·increaseIncrease our focus on intellectual property protection and strategy.strategy;
·Expand the sales and marketing of our VectorVision product line; and
·Explore opportunities and channels to enter the expansive market opportunity in China for non-pharmacologic treatments of macular degeneration, glaucoma and diabetic retinopathy.

 

The FDA and other regulatory bodies require electronic medical devices to comply with IEC 60601 standards. The International Electrical Commission (“IEC”) established technical standards for the safety and effectiveness of medical electrical equipment. Adherence to these standards is required for commercialization of electrical medical equipment. As a medical device powered by electricity, the MapcatSF will need to undergo testing to demonstrate compliance with the IEC 60601 standards. This testing is typically conducted by a Nationally Recognized Testing Laboratory (“NRTL”), which is an independent laboratory recognized by the Occupational Safety and Health Administration (“OSHA”) to test products to the specifications of applicable product safety standards. We are in discussions with our contract manufacturer of the MapcatSF to engage an NRTL at the appropriate juncture prior to commercialization of the MapcatSF. The relevant predicate device for the MapcatSF is the MPS II, the applicable Class I product code for the MapcatSF is HJW and the applicable Code of Federal Regulation is 886.1050. The FDA does not require test documents to be submitted to the FDA for a Class I medical device, but that the evidence of such testing be placed in a Design History file and be kept internally at the Companycompany or manufacturer and readily available should the FDA or other regulatory bodies request to review the testing documents. While the FDA does not require that a Class I medical device have formal validation, we expect to complete applicable IEC 60601-1 testing prior to commercialization as we believe in marketing a product that has evidence that it is safe and effective.

 

Results of Operations

 

Through March 31, 2017,2018, we had limited operations and have primarily been engaged in research, and development, commercialization and raising capital. We have incurred and will continue to incur significant expenditures for the development of our products and intellectual property, which includes research and development of both medical foods and medical diagnostic equipment for the treatment of various eye diseases. We had limited revenue during the three-month periodsquarters ended March 31, 2018 and 2017. In the fourth quarter of 2017, and 2016, all of which was generated bywe began recognizing product revenue from the sale of VectorVision products in addition to sales of our proprietary product, Lumega-Z. In late 2014, we changed our focus from the dietary supplement category to the medical food category based on consultation with our intellectual property counsel and regulatory affairs consultants, as a result of which Lumega-Z is now categorized and sold as a medical food

 


Comparison of Three Months Ended March 31, 20172018 and 20162017

 

 Three Months Ended December 31,     

Three Months Ended

March 31,

    
 2017  2016  Change  

2018

(unaudited)

  

2017

(unaudited)

  Change 
Revenue $55,941  $29,134  $26,807   92% $193,040  $55,941  $137,099   245%
Cost of goods sold  22,633   14,247   8,386   59%  79,278   22,633   56,645   250%
Gross Profit  33,308   14,887   18,421   124%  113,762   33,308   80,454   242%
Operating Expenses:                                
Research and development  10,239   10,172   67   1%  159,588   10,239   149,349   1,459%
Sales and marketing  76,736   103,578   (26,842)  (26)%  605,990   76,736   529,254   690%
General and administrative  598,913   623,956   (25,043)  (4)%  1,680,810   598,913   1,081,897   181%
Total Operating Expenses  685,888   737,706   (51,818)  (7)%  2,446,388   685,888   1,760,500   257%
Loss from Operations  (652,580)  (722,819)  70,239   (10)%  (2,332,626)  (652,580)  (1,680,046)  257%
Other Expense:                                
Interest expense  16,431   226,384   (209,953)  (93)%  835   16,431   (15,596)  (95)%
Net Loss $(669,011) $(949,203) $280,192   (30)% $(2,333,461) $(669,011) $(1,664,450)  249%

 


Revenue

 

For the three months ended March 31, 2017,2018, revenue from the sale of Lumega-Zproduct sales was $55,941$193,040 compared to $29,134$55,941 for the three months ended March 31, 2016,2017, resulting in an increase of $26,807$137,099 or 92%245%. The increase is reflective ofreflects both an increased customer base for Lumega-Z as we expand into new clinics.clinics and sales of VectorVision products. Approximately $72,000, or 37% of revenue in the first quarter of 2018 was generated by sales of Lumega-Z products, representing a 27% increase in Lumega-Z sales over the prior period.

The following table presents our revenues disaggregated by product type:

  Three Months Ended March 31, 
  2018  2017 
Lumega-Z and supplements  $72,138   $55,941 
VectorVision medical devices and supplies  120,902   - 
   $193,040   $55,941 

 

Cost of Goods Sold

 

For the three months ended March 31, 2017,2018, cost of goods sold from the sale of Lumega-Z was $22,633$79,278 compared to $14,247$22,633 for the three months ended March 31, 2016,2017, resulting in an increase of $8,386$56,645 or 59%250%. The increase corresponds to the additional sales recorded in 2017.2018.

 

Research and Development

 

For the three months ended March 31, 2017,2018, research and development costs were $159,588 compared to $10,239 consistentfor the three months ended March 31, 2017, resulting in an increase of $149,349 or 1,459%. The increase was due to research associated with the $10,172 cost from the comparable period in 2016.our MapcatSF® medical device.

 

Sales and Marketing

 

For the three months ended March 31, 2017,2018, sales and marketing expenses were $76,736$605,990 compared to $103,578$76,736 for the comparable period in 2016.three months ended March 31, 2017. The decreaseincrease in sales and marketing expenses of $26,842$529,254 or 26%690% compared to the prior period was due primarily to our hiring and training of a decreasenational sales team, an increased presence at trade shows, and an increase in non-cash stock compensation expense.multimedia marketing initiatives.

 


General and Administrative

 

For the three months ended March 31, 2017,2018, general and administrative expenses were $598,913$1,680,810 compared to $623,956$598,913 for the three months ended March 31, 2016.2017. The decreaseincrease of $25,043$1,081,897 or 4%181% compared to the prior period was primarily due to a $48,859 reduction$627,000 increase in non-cash stock compensation expense fromexpenses recorded during the prior period, partially offset by an increase in accruedcurrent period. Labor, legal, and management fees.consulting costs also increased during the period.

 

Interest Expense

 

For the three months ended March 31, 2017,2018, interest expense was $16,431$835 compared to $226,384$16,431 for the comparable period of 2016.three months ended March 31, 2017. The decrease in interest expense of $209,953$15,596, or 93% compared to the prior year95%, was due to the settlement, during 2016,repayment or conversion of the majority ofall promissory notes and convertible debt that had been outstanding at the end of 2015.during 2017.

 

Net Loss

 

For the three months ended March 31, 2017,2018, we incurred a net loss of $669,011,$2,333,461, compared to a net loss of $949,203$669,011 for the three months ended March 31, 2016.2017. The decreaseincrease in net loss of $280,192$1,664,450 or 30%249% compared to the prior year period was primarily due to the reduction of $209,953 in interest expense related to promissory notes and convertible debt that was settled in 2016, as well as to reduced stock compensation expense of $777,513 incurred in the current quarter, ($160,781 was recognized in the current quarter versus $249,019 in the prior year period).addition of and training for a national sales team, increased marketing initiatives, increased legal expenses and internal labor costs.

 


Liquidity and Capital Resources

 

Since our formation in 2009, we have devoted substantial effort and capital resources to the development and commercialization activities related to our lead product Lumega-Z and our MapcatSF medical device. As a result of ourthese activities we utilized cash in operating activities of $445,576$1,353,530 during the three months ended March 31, 2017.2018. We had negativepositive working capital of $262,748$2,953,371 at March 31, 2018 due primarily to our sale of common stock in November 2017. As of March 31, 2017,2018, we had cash in the amount of $444,850$3,198,349 and no available borrowings. Our financing has historically come from the issuance of convertible notes, and promissory notes and to a lesser extent from the sale of common and preferred stock and exercise of warrants.

 

The financial statements have been prepared assuming wethe Company will continue as a going concern. We expectThe Company had a net loss of $2,333,461 and utilized cash in operating activities of $1,353,530 during the three months ended March 31, 2018. The Company expects to continue to incur net losses and negative operating cash flows in the near-term. As a result, management has concluded that there is substantial doubt about ourthe Company’s ability to continue as a going concern within one year of the date that the financial statements are issued.

 

The Company’s auditors haveindependent registered public accounting firm has also included explanatory language in their opinion that there is substantial doubt aboutaccompanying the Company’s ability to continue as a going concern.audited financial statements for the year ended December 31, 2017. The Company’s financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the possible inability of the Company to continue as a going concern.

 

WeThe Company will continue to incur significant expenses for continued commercialization activities related to its lead product Lumega-Z, the MapcatSF® medical device, and with respect to efforts to build our infrastructure.VectorVision products. Development and commercialization of medical foods and medical devices involves a lengthy and complex process. Additionally, ourthe Company’s long-term viability and growth willmay depend upon the successful development and commercialization of new complementary products other than Lumega-Z and the MapcatSF. We areor product lines. The Company is continuing attempts to raise additional debt and/or equity capital to fund future operations, but there can be no assurances that wethe Company will be able to secure such additional financing in the amounts necessary to fully fund its operating requirements on acceptable terms or at all. If we arethe Company is unable to access sufficient capital resources on a timely basis, wethe Company may be forced to reduce or discontinue its technology and product development programs and ultimately curtail or cease operations.

 


Sources and Uses of Cash

 

The following table sets forth our major sources and uses of cash for each of the following periods:

 

 Three Months Ended March 31,  

Three Months Ended

March 31,

 
 2017  2016  2018  2017 
Net cash used in operating activities $(445,576) $(363,862) $(1,353,530) $(445,576)
Net cash used in investing activities  -   (1,171)  (145,111)  - 
Net cash provided by financing activities  827,906   336,300 
Net increase (decrease) in cash $382,330  $(28,733)
Net cash (used in) provided by financing activities  (38,240)  827,906 
Net (decrease) increase in cash $(1,536,881) $382,330 

 

Operating Activities

 

Net cash used in operating activities was $445,576$1,353,530 during the three months ended March 31, 2017,2018, versus $363,862$445,576 used during the comparable prior year period. The increase in 20172018 was due primarily to additional generalhigher sales, marketing, labor, and administrative costs paid for consulting and other professional services.legal costs.

 

Investing Activities

 

Net cash used in investing activities was $145,111 for the three months ended March 31, 2018 and $0 for the three months ended March 31, 2017 and $1,1712017. In January 2018, we acquired the rights to a trademark portfolio for the three months ended March 31, 2016, and consisted of investment$50,000. In addition, we invested in property and equipment.a trade show booth in February.

 

Financing Activities

 

Net cash provided byused in financing activities was $827,906$38,240 for the three months ended March 31, 2017.2018 was due primarily to our payoff of a line of credit balance that had been assumed from the VectorVision transaction. Financing activities for the 2017prior year comparable period provided proceeds of $100,000 from the issuance of short-term loans, partially offset by payments of principal and interest on those loans of $14,000, $700,000 in proceeds from the issuance of preferred stock,Series B Preferred Stock, and $41,906 in amounts due to related parties on a net basis.

 

Net cash provided by financing activities was $336,300 the year ended March 31, 2016. Financing activities for 2016 provided proceeds of $251,000 from the issuance of convertible notes and promissory notes, and $85,300 in amounts due to related parties on a net basis.


Off-Balance Sheet Arrangements

 

At March 31, 20172018 and December 31, 2016,2017, we did not have any transactions, obligations or relationships that could be considered off-balance sheet arrangements.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable.

 

ITEM 4. CONTROLS AND PROCEDURES

 

As of the end of the period covered by this Quarterly Report on Form 10-Q, the Company carried out an evaluation, under the supervision and with the participation of the Company’s management, including the Company’s Chief Executive Officer and Chief Accounting Officer, of the effectiveness of the design and operation of the Company’s disclosure controls and procedures pursuant to Exchange Act Rule 13a-15. Based upon this evaluation, the Chief Executive Officer and Chief Accounting Officer each concluded that the Company’s disclosure controls and procedures are effective to provide reasonable assurance that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified by the SEC’s rules and forms, and that such information has been accumulated and communicated to the Company’s management, including the Company’s Chief Executive Officer and Chief Accounting Officer, in a manner that allows timely decisions regarding required disclosure. There have been no changes in the Company’s internal control over financial reporting identified in connection with the evaluation that occurred during the first quarter ended in 20172018 that have materially affected, or are reasonably likely to materially affect, the internal control over financial reporting.

23 


PART II – OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

The Company is periodically the subject of various pending or threatened legal actions and claims arising out of its operations in the normal course of business. In the opinion of management of the Company, adequate provision has been made in the Company’s condensed consolidated financial statements at March 31, 20172018 with respect to such matters, including the matter noted below.

 

TheOn or about July 26, 2017, the Company recently received a payment demand from a former consultant to the Company alleging that hethe consultant is owed $102,000approximately $192,000 for unpaid services rendered. The Company is evaluating the claimhas disputed this demand and intendsattempts to respond to the former consultant’s demand in due course. Ifresolve this matter results inwere unsuccessful. On January 29, 2018, the filing ofCompany filed a lawsuit against the Company,consultant and its related entities in the United States District Court for the Southern District of California (Case No. 18CV200-W-KSC) seeking declaratory relief regarding advisory fees and ownership interest in the Company. On March 6, 2018, the consultant and its related entities filed counterclaims against the Company, intends to vigorously defend itselfseeking payment for services rendered and seeking declaratory relief regarding ownership interest in the Company. The Company cannot predict the outcome of this matter and believes it has provided appropriate provision for any settlement of this matter as well, will consider filing a counterclaim for damages against the former consultant.of March 31, 2018.

 

ITEM 1A. RISK FACTORS

 

As of the date of this filing, there have been no material changes to the Risk Factors included in the Company’s Annual Report on Form 10-KNot required for the fiscal year ended December 31, 2016, as filed with the SEC on March 30, 2017 (the “2016 Form 10-K”). The Risk Factors set forth in the 2016 Form 10-K should be read carefully in connection with evaluating the Company’s business and in connection with the forward-looking statements contained in this Quarterly Report on Form 10-Q. Any of the risks described in the 2016 Form 10-K could materially adversely affect the Company’s business, financial condition or future results and the actual outcome of matters as to which forward-looking statements are made. These are not the only risks that the Company faces. Additional risks and uncertainties not currently known to the Company or that the Company currently deems to be immaterial also may materially adversely affect the Company’s business, financial condition and/or operating results.smaller reporting companies.

 

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

 

In January 2018, an investor exercised warrants for 146,000 shares of common stock. The warrants were exercisable for $0.01 per share, and the Company received $1,460 in cash. The Company issued the shares and recorded the cash received as additional equity.

On January 26, 2018, the Company issued a stock option to a consultant to purchase a total of 500,000 shares of the common stock of the Company. 250,000 shares of the option with a fair value of $287,500 vested immediately, 125,000 shares vest on December 31, 2018 and the remaining 125,000 shares vest on December 31, 2019 provided the consultant is still an active service provider. The options are non-qualified, have an exercise price of $1.25 per share, and will expire after 5 years. As of March 31, 2018, the 250,000 options that remain to vest were valued in total at $287,500 based upon a Black-Scholes option-pricing model. During the three months ended March 31, 2017,2018, the Company sold 700,000 sharesrecognized stock compensation costs of the Company’s Series B Convertible Preferred Stock to various investors. The purchase price of the stock was $1.00 per share, for an aggregate purchase price of $700,000. The stock has a stated value of $1.00 per share and accrues an annual dividend at the rate of 6% of the stated value, calculated quarterly, to be paid in shares of common stock at the rate of $0.75 per share. Series B preferred stock is convertible commencing December 31, 2017, or earlier upon the approval of the Board of Directors, by the holder into common stock at $0.75 per share. The stock is automatically convertible by the Company upon an equity financing of at least $5,000,000 subsequent to June 30, 2017, or is publicly traded for at least $2.00 per share for 10 consecutive trading days, or upon completion of a Major Transaction (as defined in the Certificate of Designation). Dividends are payable to holders of record quarterly, on the last business day of each calendar quarter, from the date of issuance, as may be declared by the Board of Directors, and are cumulative. Series B preferred stock is senior to all Common Stock and junior to the Series A preferred stock.

During the three months ended March 31, 2017, in connection with the Series B Convertible Preferred Stock offering, the Company issued a total of 60,000 warrants as additional incentive to investors who had previously invested in the Company’s Series A Senior Convertible Preferred Stock offering in 2016. These warrants are fully vested, are immediately exercisable at $0.75 per share, and expire between March 6, 2020 and March 8, 2020. The warrants were valued at $51,796, based upon the Black-Scholes option-pricing model, with a stock price of $0.88, volatility of 135%, and an average risk-free interest rate of 1.61%.

The offerings of Series A Preferred Stock and Series B Preferred Stock were exempt from registration pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, and Regulation D and/or Regulation S promulgated thereunder. No sales commissions were paid in connection with these transactions and no placement agent or underwriter was involved.

During the three months ended March 31, 2017, the Company issued 162,500 shares of restricted common stock to a service provider. These shares are subject to vesting requirements over 4 months and remain subject to forfeiture if vesting conditions are not met. The aggregate fair value of the stock was $143,000 based on a valuation per share of $0.88 on the date of grant. During the three months ended March 31, 2017, the Company recorded $100,833 of expense$20,782 related to the vested portionamortization of this restricted stock. The securities issued in the above transaction were exempt from registration under Section 4(a)(2) of the Securities Act of 1933, as amended, as such transaction did not involve any public offering. No sales commissions were paid in connection with this transaction and no placement agent or underwriter was involved.these options based upon a graded vesting schedule.


ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

Not applicable.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5. OTHER INFORMATION

 

Not applicable.

 

ITEM 6. EXHIBITS

 

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

 

25 


SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized on the 11th day of May, 2017.2018.

 

GUARDION HEALTH SCIENCES, INC.
By:/s/ Michael Favish
Name:Michael Favish
Title:Chief Executive Officer

POWER OF ATTORNEY

We, the undersigned officers and directors of GUARDION HEALTH SCIENCES, INC., hereby severally constitute and appoint Michael Favish and Vincent J. Roth, and each of them (with full power to each of them to act alone), our true and lawful attorneys-in-fact and agents, with full power of substitution, for us in any and all capacities, to sign any amendments to this Form 10-Q, and to file the same, with exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them, or their substitute or substitutes, may lawfully do or cause to be done by virtue thereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed by the following persons in the capacities and on the dates indicated.

 

Signature Title Date
     
/s/ Michael Favish CEO, President and May 11, 20172018
Michael Favish 

Chairman of the Board

(Principal Executive Officer)

  
     
/s/ John Townsend Controller and Chief Accounting Officer May 11, 20172018
John Townsend (Principal Accounting Officer)  

INDEX TO EXHIBITS

 

Exhibit No. Description
3.1 Certificate of DesignationElimination of theDesignations, Preferences and Rights Preferences, Privileges and Restrictions of Series A Convertible Preferred Stock with Certificate of Correction (1)
3.2Certificate of Designation of the Rights, Preferences, Privileges and Restrictions of Series B Convertible Preferred Stock (2)(incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 2, 2018)
4.131.1 Form of Preferred Stock Purchase Agreement (1)
4.2Form of Series B Preferred Stock Purchase Agreement (2)
31.1Certification of Chief Executive Officer pursuant to Rule 13a – 14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2 Certification of Chief Accounting Officer pursuant to Rule 13a – 14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.132.1* Certification of Chief Executive Officer and Chief Accounting Officer pursuant to 18.U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002
101 The following materials from the Company’s Quarterly Report on Form 10-Q for the year ended March 31, 2017,2018, formatted in XBRL (eXtensible Business Reporting Language), (i) Balance Sheets, (ii) Statements of Income, (iii) Statements of Comprehensive Income, (iv) Statements of Cash Flows, (v) Statement of Stockholders’ Equity and (vi) Notes to Financial Statements

  

*(1)filed on Form 8-K on January 5, 2017 andA certification furnished pursuant to Item 601(b)(2) of the Regulation S-K will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section. Such certification will not be deemed to be incorporated hereinby reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent that the registrant specifically incorporates it by reference.

(2)filed on Form 8-K on March 23, 2017 and incorporated herein by reference.

27