UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

 

xFORM 10-Q

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

For the quarterly period ended June 30, 2018

OR2019

 

¨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)

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.001 per shareGHSIThe NASDAQ Stock Market LLC

 

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 [X] Yes ¨[  ] No

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, 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 [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¨[X]Smaller reporting companyx[X]
(Do not check if a smaller reporting company)Emerging growth companyx[X]

 

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¨ [  ]

 

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

 

As of August 10, 2018,9, 2019, there were 40,329,47522,733,762 shares of the Registrant’sCompany’s common stock, par value $0.001 per share, issued and outstanding. Registrant’sThe Company’s common stock is not publicly traded. began trading on the NASDAQ Capital Market on April 5, 2019, under the symbol “GHSI.”

 

 

 

 

 

TABLE OF CONTENTS

 

  Page No.
PART I – FINANCIAL INFORMATION 
   
ITEM 1.CONDENSED CONSOLIDATED FINANCIAL STATEMENTS4
   
 Balance Sheets – As of June 30, 20182019 (Unaudited) and December 31, 201720184
   
 Statements of Operations (Unaudited) – Three and Six Months Ended June 30, 20182019 and June 30, 201720185
   
 Statement of Stockholders’ Equity (Unaudited) – Three and Six Months Ended June 30, 2019 and 20186
   
 Statements of Cash Flows (Unaudited) – Six Months Ended June 30, 20182019 and June 30, 201720187
   
 Notes to Condensed Consolidated Financial Statements (Unaudited)8
   
ITEM 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS1821
   
ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK2834
   
ITEM 4.CONTROLS AND PROCEDURES2834
   
PART II – OTHER INFORMATION 
   
ITEM 1.LEGAL PROCEEDINGS2935
   
ITEM 1A.RISK FACTORS2935
   
ITEM 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS2935
   
ITEM 3.DEFAULTS UPON SENIOR SECURITIES2935
   
ITEM 4.MINE SAFETY DISCLOSURES2935
   
ITEM 5.OTHER INFORMATION3035
   
ITEM 6.EXHIBITS3035
   
SIGNATURES 3036

 

 2 

 

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 (this “Report”) contains forward-looking 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 forward-looking statements relate to future eventscontain information about our expectations, beliefs or future predictions, including eventsintentions regarding our product development and commercialization efforts, business, financial condition, results of operations, strategies or predictions relating to the Company’s future financial performance,prospects, and other similar matters. These forward-looking statements are based on management’s current expectations estimates, forecasts and projectionsassumptions about the Company, its future performance, its beliefsevents, which are inherently subject to uncertainties, risks and management’s assumptions.  Theychanges in circumstances that are generally identifiabledifficult to predict. These statements may be identified by use of the words “may,such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “expect,“intends,“plan,“estimates,“anticipate,” “believe,” “feel,” “confident,” “estimate,” “intend,” “predict,” “forecast,” “potential”and other words of similar meaning. Actual results could differ materially from those contained in forward-looking statements. Many factors could cause actual results to differ materially from those in forward-looking statements.

Other unknown or “continue” or the negativeunpredictable factors that could also adversely affect our business, financial condition and results of such terms or other variations onoperations may arise from time to time. Given these words or comparable terminology. These statements involve unknown risks and uncertainties, thatthe forward-looking statements discussed in this Report may individually or materially impact the matters discussed herein for a variety of reasons that are outside the control of the Company, including, but not limitedprove to the Company’s ability to raise sufficient financing to implement its business plan and its ability to successfully develop and commercialize its proprietary products and technologies. Readers are cautionedbe accurate. Accordingly, you should not to place undue reliance on these forward-looking statements, which only reflect the views of the Company’s management as actual results could differ materially from those described inof the date of this Report. We undertake no obligation to update or revise forward-looking statements contained herein. to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results or expectations, except as required by law.

Readers are urged to read the risk factors set forth in the Company’s recent filings with the U. S. Securities and Exchange Commission (the “SEC”), including the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 20172018 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, whether as a result of new information, future events or otherwise, in 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.

 3 

 

PART I – FINANCIAL INFORMATION

 

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Guardion Health Sciences, Inc.

Condensed Consolidated Balance Sheets

 

 June 30,  December 31,  June 30, December 31, 
 2018  2017  2019  2018 
 (Unaudited)    (Unaudited)    
Assets                
                
Current assets                
Cash $2,066,365  $4,735,230  $2,368,645  $670,948 
Accounts receivable  29,843   72,771   35,920   28,203 
Inventories  412,357   154,730   318,686   357,997 
Prepaid expenses  25,830   117,164   132,306   47,773 
                
Total current assets  2,534,395   5,079,895   2,855,557   1,104,921 
                
Deposits  11,751   10,470   11,751   11,751 
Property and equipment, net  191,427   95,597   303,929   274,804 
Right of use asset, net  595,598   - 
Deferred offering costs  19,000   270,000 
Intangible assets, net  563,423   620,741   348,786   456,104 
Goodwill  1,563,520   1,563,520   1,563,520   1,563,520 
                
Total assets $4,864,516  $7,370,223  $5,698,141  $3,681,100 
                
Liabilities and Stockholders’ Equity                
                
Current liabilities                
Accounts payable and accrued liabilities $457,438  $311,236  $300,239  $413,925 
Accrued expenses and deferred rent  11,618   12,043   25,000   81,412 
Line of credit  -   30,535 
Due to related parties  117,473   146,133 
Derivative warrant liability  78,440   - 
Lease liability – current  125,237   - 
Total current liabilities  528,916   495,337 
                
Total current liabilities  586,529   499,947 
Lease liability – long term  481,137   - 
        
Total liabilities  1,010,053   495,337 
                
Commitments and contingencies                
                
Stockholders’ Equity                
                
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 June 30, 2018 and December 31, 2017, respectively  40,329   40,183 
Common stock, $0.001 par value; 90,000,000 shares authorized; 22,733,762 and 20,564,328 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively  22,734   20,564 
Additional paid-in capital  35,246,639   33,696,049   43,735,894   37,798,562 
Accumulated deficit  (31,008,981)  (26,865,956)  (39,070,540)  (34,633,363)
                
Total stockholders’ equity  4,277,987   6,870,276   4,688,088   3,185,763 
                
Total liabilities and stockholders’ equity $4,864,516  $7,370,223  $5,698,141  $3,681,100 

 

See accompanying notes to condensed consolidated financial statements.

 

 4 

 

 

Guardion Health Sciences, Inc.

Condensed Consolidated Statements of Operations

 

 

Three Months Ended

June 30,

 

Six Months Ended

June 30,

  

Three Months Ended

June 30,

 

Six Months Ended

June 30,

 
 2018  2017  2018  2017  2019  2018  2019  2018 
 (Unaudited) (Unaudited) (Unaudited) (Unaudited)  (Unaudited) (Unaudited) (Unaudited) (Unaudited) 
Revenue $220,778  $59,977  $413,818  $115,912                 
Medical foods $104,448  $79,993  $204,382  $154,294 
Vision testing diagnostics  150,222   140,785   292,826   259,524 
Other  6,300   -   6,300   - 
Total revenue  260,970   220,778   503,508   413,818 
                                
Cost of goods sold  87,776   29,692   167,055   52,326                 
Medical foods  40,681   40,959   78,953   72,238 
Vision testing diagnostics  53,816   46,817   109,036   94,817 
Other  2,559   -   2,559   - 
Total cost of goods sold  97,056   87,776   190,548   167,055 
                                
Gross profit  133,002   30,285   246,763   63,586   163,914   133,002   312,960   246,763 
                                
Operating expenses                                
Research and development  34,320   15,530   194,708   25,770   77,688   34,320   106,716   194,708 
Sales and marketing  378,750   101,598   984,464   178,333   409,409   378,750   764,028   984,464 
General and administrative  1,034,914   766,894   2,714,680   1,365,807   2,489,011   1,034,914   3,439,633   2,714,680 
                                
Total operating expenses  1,447,984   884,022   3,893,852   1,569,910   2,976,108   1,447,984   4,310,377   3,893,852 
                                
Loss from operations  (1,314,982)  (853,737)  (3,647,089)  (1,506,324)  (2,812,194)  (1,314,982)  (3,997,417)  (3,647,089)
                                
Other expenses:                
Other (income) expense:                
Interest expense  710   1,924   1,545   18,355   234,065   710   251,637   1,545 
Fair value of warrants - extension of expiration dates  494,391   -   494,391   - 
Finance cost upon issuance of warrants  229,921   -   415,955   - 
Change in fair value of derivative warrants  (227,832)  -   (227,832)  - 
Costs associated with extension of warrant expiration dates  -   494,391   -   494,391 
                                
Total other expenses  495,101   1,924   495,936   18,355 
Total other (income) expense  236,154   495,101   439,760   495,936 
                                
Net loss  (1,810,083)  (855,661)  (4,143,025)  (1,524,679) $(3,048,348) $(1,810,083) $(4,437,177) $(4,143,025)
                                
Adjustments related to Series A and Series B convertible preferred stock:                
Accretion of deemed dividend  -   (53,675)  -   (85,517)
Dividend declared  -   (45,106)  -   (81,183)
Net loss attributable to common shareholders $(1,810,083) $(954,442) $(4,143,025) $(1,691,379)
                
Net loss per common share – basic and diluted $(0.04) $(0.04) $(0.10) $(0.07) $(0.14) $(0.09) $(0.21) $(0.21)
Weighted average common shares outstanding – basic and diluted  40,329,475   25,470,418   40,322,215   25,287,759   22,537,943   20,164,761   21,628,758   20,161,131 

 

See accompanying notes to condensed consolidated financial statements.

 

 5 

 

 

Guardion Health Sciences, Inc.

Condensed Consolidated Statement of Stockholders’ Equity

(Unaudited)

 

 Common Stock         Common Stock  

Additional

Paid-In

  Accumulated  

Total

Stockholders’

 
 Shares  Amount  

Additional

Paid-In

Capital

 

Accumulated

Deficit

 

Total

Stockholders’

Equity

  Shares  Amount  Capital  Deficit  Equity 
Balance at December 31, 2017  40,183,475  $40,183  $33,696,049  $(26,865,956) $6,870,276 
 Three and Six Months Ended June 30, 2019 
Balance at December 31, 2018  20,564,328  $20,564  $37,798,562  $(34,633,363) $3,185,763 
Fair value of vested stock options  -   -   1,054,885   -   1,054,885   -   -   56,232   -   56,232 
Issuance of common stock – warrant exercises  146,000   146   1,314   -   1,460   292,283   293   30,957   -   31,250 
Fair value of warrants - extension of expiration dates          494,391       494,391 
Net loss  -   -   -   (4,143,025)  (4,143,025)  -   -   -   (1,385,099)  (1,385,099)
Balance at June 30, 2018  40,329,475  $40,329  $35,246,639  $(31,008,981) $4,277,987 
Balance at March 31, 2019  20,856,611   20,857   37,885,751   (36,018,462)  1,888,146 
Fair value of vested stock options – officer and director  -   -   1,066,159   -   1,066,159 
Fair value of vested stock options  -   -   62,763   -   62,763 
Reclass of warrant liability to equity  -   -   359,683   -   359,683 
Sale of common stock  1,250,000   1,250   3,886,750   -   3,888,000 
Issuance of common stock for services  54,387   55   123,947   -   124,002 
Issuance of common stock – warrant exercises  463,726   463   100,162   -   100,625 
Fair value of common stock – conversion of notes payable and related interest  109,038   109   250,679   -   250,788 
Net loss              (3,052,078)  (3,052,078)
Balance at June 30, 2019  22,733,762  $22,734  $43,735,894  $(39,070,540) $4,688,088 

  

Three and Six Months Ended June 30, 2018

 
Balance at December 31, 2017  20,091,761  $20,092  $33,716,140  $(26,865,956) $6,870,276 
Fair value of vested stock options  -   -   777,513   -   777,513 
Issuance of common stock – warrant exercises  73,000   73   1,387   -   1,460 
Net loss  -   -   -   (2,333,461)  (2,333,461)
Balance at March 31, 2018  20,164,761   20,165   34,495,040   (29,199,417)  5,315,788 
Fair value of vested stock options  -   -   277,372   -   277,372 
Costs associated with extension of warrant expiration dates  -   -   494,391   -   494,391 
Net loss  -   -   -   (1,809,564)  (1,809,564)
Balance at June 30, 2018  20,164,761  $20,165  $35,266,803  $(31,008,981) $4,277,987 

 

See accompanying notes to condensed consolidated financial statements.

 

 6 

 

Guardion Health Sciences, Inc.

Condensed Consolidated Statements of Cash Flows

 

 

Six Months Ended

June 30,

  

Six Months Ended

June 30,

 
 2018  2017  2019  2018 
 (Unaudited) (Unaudited)  (Unaudited) (Unaudited) 
Operating Activities                
Net loss $(4,143,025) $(1,524,679) $(4,437,177) $(4,143,025)
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation and amortization  148,560   31,331   137,128   148,560 
Amortization of debt discount  250,000   - 
Accrued interest expense included in notes payable  -   13,746   788   - 
Amortization of right of use asset  61,571   - 
Stock-based compensation  1,054,885   405,918   242,996   1,054,885 
Stock-based compensation – related parties  -   108,051 
Fair value of warrant modification  494,391   - 
Stock-based compensation – officer and director  1,066,159   - 
Non-cash financing costs – derivative liability  415,955   - 
Change in fair value of warrants – derivative liability  (227,832)  - 
Costs associated with extension of warrant expiration dates  -   494,391 
Changes in operating assets and liabilities:                
(Increase) decrease in -                
Accounts receivable  42,928   11   (7,718)  42,928 
Inventories  (257,627)  (64,305)  39,311   (257,627)
Deposits and prepaid expenses  90,053   22,788   (84,533)  90,053 
Lease liability  (56,844)  - 
Increase (decrease) in -                
Accounts payable and accrued expenses  146,202   57,442   156,314   146,202 
Accrued and deferred rent costs  (425)  (73,624)
Accrued expenses and deferred rent  (49,814)  (425)
                
Net cash used in operating activities  (2,424,058)  (1,023,321)  (2,493,696)  (2,424,058)
                
Investing Activities                
Purchase of property and equipment  (137,073)  (5,500)  (58,934)  (137,073)
Purchase of intellectual property  (50,000)  -   -   (50,000)
                
Net cash used in investing activities  (187,073)  (5,500)  (58,934)  (187,073)
                
Financing Activities                
Proceeds from issuance of promissory notes  -   100,000 
Payments on promissory notes  -   (14,000)
Proceeds from initial public offering  3,888,000   - 
Proceeds from issuance of convertible notes  250,000   - 
Proceeds from issuance of promissory note  100,000   - 
Payments on promissory note  (100,548)  - 
Payments on line of credit  (30,535)  -   -   (30,535)
Proceeds from issuance of preferred stock  -   1,100,000 
Proceeds from exercise of warrants  1,460   -   131,875   1,460 
(Decrease) increase in due to related parties  (28,659)  77,837 
Deferred financing costs of IPO  (19,000)  - 
Decrease in due to related parties  -   (28,659)
                
Net cash (used in) provided by financing activities  (57,734)  1,263,837 
Net cash provided by (used in) financing activities  4,250,327   (57,734)
                
Cash:                
Net (decrease) increase  (2,668,865)  235,016 
Net decrease  1,697,697   (2,668,865)
Balance at beginning of period  4,735,230   62,520   670,948   4,735,230 
Balance at end of period $2,066,365  $297,536  $2,368,645  $2,066,365 
                
Supplemental disclosure of cash flow information:                
Cash paid for-                
Interest $-  $1,500  $-  $- 
Income taxes $-  $-  $-  $- 
                
Non-cash financing activities:                
Issuance of common stock dividends on preferred stock $-  $81,183 
Fair value of warrant liability issued in connection with issuance of convertible notes $436,034  $- 
Recording of lease asset and liability upon adoption of ASU 2016-02 $663,218  $- 
Reclass of warrant liability to equity $359,683  $- 
Fair value of common stock issued upon conversion of common stock and accrued interest $250,788  $- 
Reclass of deferred offering cost to equity $270,000  $- 

 

See accompanying notes to condensed consolidated financial statements.

 7 

 

 

Guardion Health Sciences, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Six Months Ended June 30, 20182019 and 20172018

 

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 that develops, formulates and distributes 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. Lumega-Z has been used in IRB-approved patient studies to examine its effectiveness. On May 9, 2019, the Company announced in a press release a recent study that showed statistically significant improvement in visual function (“CSF”) of patients taking Lumega-Z who participated in the study. The study was conducted by research scientists at the Western University College of Optometry to evaluate the visual benefits of Lumega-Z in one group of patients as compared to a group of patients taking AREDS 2 soft gel supplements. Each patient has retinal drusen and is at risk of developing AMD. The results of the study were presented at the Association for Research in Vision and Ophthalmology (“ARVO”) 2019 annual meeting and showed improvements in visual function (“CSF”) in the group of patients taking Lumega-Z that were statistically significant and definitive. The patients taking AREDS 2 showed no statistical change.

 

The Company also developed a proprietary medical device called the MapcatSF®that accurately measures the macular pigment optical density. On July 16, 2019, the Company was notified by the Patents Registry in Hong Kong that it has received a patent from the Government of the Hong Kong Special Administrative Region (Hong Kong Patent No. HK1204758 titled “Apparatus for Use in the Measurement of Macular Pigment Optical Density and/or Lens Optical Density of an Eye”) for the MapcatSF®. On May 30, 2019, the Company was notified by the European Patent Office that it has received a patent from the European Union (European Patent No. 2,811,892 titled “Apparatus for Use in the Measurement of Macular Pigment Optical Density and/or Lens Optical Density of an Eye”) for the MapcatSF®.

 

On September 29, 2017, the Company, through its wholly owned subsidiary VectorVision Ocular Health, Inc. (“VectorVision”), completed its acquisition of substantially all of the assets and certain liabilities of VectorVision, Inc. (an Ohio corporation), a company that specializesspecialized in the standardization of contrast sensitivity, glare sensitivity, low contrast acuity, and ETDRSearly treatment diabetic retinopathy study (“ETDRS”) visual acuity testing. VectorVision develops, manufactures and sells equipment and supplies for standardized vision testing. The acquisition expands the Company’s technical portfolio. CSV-1000 and CSV-2000 instruments offer auto-calibrated tests to ensure correct testing luminance and contrast levels for consistent, highly accurate and repeatable results. Recently issued patents the Company received for continuously calibrating the light source will be incorporated into the new CSV-2000, in which the proprietary standardized contrast sensitivity test patterns can be presented to the patient using a computer monitor as opposed to the current calibrated backlit system.

In August 2018, the Company created a wholly owned subsidiary, Transcranial Doppler Solutions, Inc. (“TDSI”). TDSI is dedicated to the pursuit of early predictors resulting in, the Company believes, valuable therapeutic intervention for practitioners and their patients, and additional revenue streams generated from the testing and sale of Company products to appropriate customers. The Company has established operations with selected clinics and is focusing on expanding its client base.

In November 2018, the Company launched a new medical food product, GlaucoCetinTM, which the Company believes is the first vision-specific medical food designed to support and protect the mitochondrial function of optic nerve cells and improve blood flow in the ophthalmic artery in patients with glaucoma. The Company believes GlaucoCetinTM is the first vision-specific medical food designed to support and protect the mitochondrial function of optic nerve cells and improve blood flow in the ophthalmic artery in patients with glaucoma. The parent compound of GlaucoCetinTM, called “GlaucoHealth,” was designed by Robert Ritch, M.D., one of the Company’s Medical Advisory Board members. Dr. Robert Ritch holds the Shelley and Steven Einhorn Distinguished Chair in Ophthalmology and is surgeon Director Emeritus and Chief of Glaucoma Services at the New York Eye and Ear Infirmary. Dr. Ritch has devoted his career to broadening the understanding of the underlying etiologies and mechanisms of glaucoma. The Company now owns the GlaucoHealth formula. On June 4, 2019, the Company announced in a press release that the formula was used in an IRB-approved patient study conducted at the New York Eye and Ear Infirmary and successfully reversed mitochondrial dysfunction in the optic nerve cells in patients with glaucoma. GlaucoCetinTM is an enhanced formulation of GlaucoHealth. The Company owns both formulas and has a patent application pending on the GlaucoCetinTM formula. The application describes an invention that provides a micro-nutrient composition for a human subject suffering from a glaucomatous disease, wherein the micro-nutrient composition comprises a formulation for reversing mitochondrial dysfunction in glaucomatous disease.

8

On April 9, 2019, the Company closedits initial public offering (the “IPO”) and issued 1,250,000 shares of its common stock at a public offering price of $4.00 per share for total gross proceeds of $5.0 million, resulting in net proceeds to the Company of $3,888,000 after deducting underwriting discounts and commissions and other offering costs and expenses payable by Guardion. The shares began trading on the Nasdaq Capital Market on April 5, 2019, under the symbol “GHSI.” In connection with the IPO, the convertible promissory notes previously issued on March 15, 2019 and March 20, 2019 were automatically converted into 109,038 shares of common stock based on a conversion price of $2.30 per share.

 

The Company has had limited operations to date and has been primarily engaged in research and development, product commercialization and capital raising activities.

 

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 $4,143,025$4,437,177 and utilized cash in operating activities of $2,424,058$2,493,696 during the six months ended June 30, 2018.2019. 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 consolidated financial statements are issued.

 

The Company’s independent registered public accounting firm has also included explanatory language in their opinion accompanying the Company’s audited financial statements for the year ended December 31, 2017.2018. 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 Lumega-Z,its medical foods, the MapcatSF® medical device, VectorVision diagnostic equipment, the TDSI business and VectorVision products.with respect to efforts to continue to build the Company’s infrastructure. 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 or product lines. other than Lumega-Z and the MapcatSF.

The Company is continuing to attemptseeking 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.

 

Reverse Stock Split

On January 30, 2019, following stockholder and Board approval, the Company filed a Certificate of Amendment to its Amended Certificate of Incorporation, as amended (the “Amendment”), with the Secretary of State of the State of Delaware to effectuate a one-for-two (1:2) reverse stock split (the “Reverse Stock Split”) of its common stock, par value $0.001 per share, without any change to its par value. The Amendment became effective on the filing date. The number of shares authorized for common and preferred stock were not affected by the Reverse Stock Split. No fractional shares were issued in connection with the Reverse Stock Split as all fractional shares were “rounded up” to the next whole share. Proportional adjustments for the Reverse Stock Split were made to all share and per share amounts as if the split occurred at the beginning of the earliest period presented.

 89 

 

 

2.Summary of Significant Accounting Policies

 

Basis of Presentation and Use of Estimates

 

The accompanying condensed consolidated financial statements are unaudited. These unaudited interim condensed consolidated financial statements have been prepared in conformityaccordance with accounting principles generally accepted in the United States of America (“GAAP”). and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting. Certain information and note disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 filed with the SEC. The condensed consolidated balance sheet as of December 31, 2018 included herein was derived from the audited consolidated financial statements as of that date, but does not include all disclosures, including notes, required by GAAP.

In the opinion of management, the accompanying unaudited condensed consolidated financial statements contain all adjustments necessary to fairly present the Company’s financial position and results of operations for the interim periods reflected. Except as noted, all adjustments contained herein are of a normal recurring nature. The results of operations for the interim periods presented are not necessarily indicative of the results of operations to be expected for the full fiscal year ending December 31, 2019.

Certain prior period amounts have been reclassified to conform to current period presentation. Such amounts consist of operating segment disclosures, whereby revenue and cost of goods sold have been broken out on the Consolidated Statements of Operations to conform with the Company’s reportable business segments as of June 30, 2019.

Use of Estimates

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.

 

These estimates and assumptions include estimates for reserves of uncollectible accounts, inventory obsolescence, depreciable lives of property and equipment, analysis of impairments of recorded long-term tangible and intangible assets, realization of deferred tax assets, accruals for potential liabilities and assumptions made in valuing stock instruments issued for services.

Intangible Assets

 

In connection with the VectorVision transaction, the Company 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, the Company determined whether these assets are expected to have indefinite (such as goodwill) or limited useful lives, and for those with limited lives, the Company established an amortization period and method of amortization. Its goodwill and other intangible assets are subject to periodic impairment testing.

 

The Company utilized the services of an independent third-party valuation firm to assist in identifying intangible assets and in estimating their fair values. The useful lives for the Company’s 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 the Company’s Statements of Operations.

 

10

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 June 30, 20182019 and December 31, 2017,2018, 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 InformationDeferred Offering Costs

 

The Company operatesDeferred offering costs consist principally of legal, accounting, and manages its business as one reporting and operating segment, which isunderwriters’ fees incurred related to the businessequity financings. These deferred offering costs will be charged against the gross proceeds received during the appropriate period. During the period ended June 30, 2019, $270,000 of developing and commercializing a varietyoffering costs deferred at December 31, 2018 were offset to paid in capital upon completion of products that support the detection, intervention and monitoringour April 2019 offering. As of a rangeJune 30, 2019, $19,000 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.costs have been deferred relating to offerings in process.

 

9

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. In addition, the Company sells medical device equipment and supplies to customers both in the U.S. and internationally.

 

In September 2014, the Financial Accounting Standards Board issued Accounting Standards Update No.Tthe Company recognizes revenue in accordance with ASU 2014-09, (ASU No. 2014-09) regarding revenue recognition.Revenue from Contracts with Customers (Topic 606)(“ASU 2014-09” or “Topic 606”) and all related amendments. 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 risk of loss transferred to its customers and collection of the receivable was 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, although for all periods presented, returns have been insignificant.

 

Under the new guidance, revenue is recognized when control of promised goods or services is transferred to the Company’s customers, in an amount that reflects the consideration the Company expects 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 sold transfers to customers upon shipment from the Company’s 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.

 

The Company provides a 30-day right of return to its 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 products is returned, 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 the Company’s products and assessment of performance obligations and transaction pricing for the Company’s sales contracts, the Company does not currently maintain a contract asset or liability balance at this time. The Company assesses its contracts and the reasonableness of its conclusions on a quarterly basis.

 

11

The following table presents the Company’s revenues disaggregated by product type:segment:

 

  

Three Months Ended

June 30,

  

Six Months Ended

June 30,

 
�� 2018  2017  2018  2017 
Lumega-Z and supplements $79,993  $59,977  $152,132  $115,912 
VectorVision medical devices and supplies  140,785   -   261,686   - 
  $220,778  $59,977  $413,818  $115,912 
  Six Months Ended
June 30,
 
  2019  2018 
Medical foods $204,382  $154,294 
Vision testing diagnostics  292,826   259,524 
Other  6,300   - 
  $503,508  $413,818 

 

10

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 stock compensation expense, are expensed as incurred and totaled $194,708$106,716 and $25,770$194,708 for the six months ended June 30, 20182019 and 2017,2018, respectively.

 

Patent Costs

The Company is the owner of three issued domestic patents, three pending domestic patent applications, one issued foreign patent in Europe, one issued foreign patent in Hong Kong, and three foreign patent applications in Canada, Europe and Hong Kong. Due to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s research efforts and any related patent applications, patent costs, including patent-related legal fees, filing fees and internally generated costs, are expensed as incurred. During the six months ended June 30, 2019 and 2018, patent costs were $61,482 and $34,298, respectively, and are included in general and administrative costs in the statements of operations.

Leases

Prior to January 1, 2019, the Company accounted for leases under Accounting Standards Codification (ASC) 840, Accounting for Leases. Effective from January 1, 2019, the Company adopted the guidance of ASU 2016-02 (ASC 842), Leases, which requires an entity to recognize a right-of-use asset and a lease liability for virtually all leases. The Company adopted ASC 842 using a modified retrospective approach. As a result, the comparative financial information has not been updated and the required disclosures prior to the date of adoption have not been updated and continue to be reported under the accounting standards in effect for those periods. The adoption of ASC 842 on January 1, 2019 resulted in the recognition of operating lease right-of-use assets of $626,667, lease liabilities for operating leases of $635,131, and a zero cumulative-effect adjustment to accumulated deficit. See Note 8 for further information regarding the impact of the adoption of ASC 842 on the Company’s financial statements.

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, directors, consultants, contractors, and employees, which include grants of employee stock options, are recognized in the financial statements based on their fair values.values in accordance with Topic 718. 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.

 

12

The

In prior periods, the Company accountsaccounted for stock option and warrant grants issued and vesting to non-employees in accordance with the authoritative guidance of the FASB whereby 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 overOn January 1, 2019, the vesting period using a graded vesting basis. In certain circumstances where there are no future performance requirements byCompany adopted Accounting Standards Update (ASU) 2018-07 which expands the non-employee, grants are immediately vestedscope of Topic 718 to include share-based payment transactions for acquiring goods and the total stock-based compensation charge is recorded in the period of the measurement date.

The Company recognizes stock compensation expense, on stock 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 over the price paid for the stock.services from nonemployees. 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 issueadoption of the new shares to satisfy stock option exercises.standard had no cumulative effect on previously reported amounts.

 

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, if applicable.stock. 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 of common stock issuable upon conversion ofassociated with 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.

11

 

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:

 

 June 30,  June 30, 
 2018  2017  2019  2018 
Warrants  2,656,423   2,983,666   261,538   2,656,423 
Options  2,625,000   -   2,612,500   2,625,000 
Estimated shares issuable upon conversion of convertible notes payable  -   31,250 
Shares issuable upon conversion of convertible preferred stock  -   4,308,600 
  5,281,423   7,323,516   2,874,038   5,281,423 

 

Recent Accounting Pronouncements

The Company’s management does not believe that there are any 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.Segment Reporting

The Company determined its reporting units in accordance with ASC 280, “Segment Reporting” (“ASC 280”). The Company historically has reported its operating results as a single reportable segment described as 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 (“CODM”), has historically reviewed financial information on an aggregated basis for purposes of allocating resources and evaluating financial performance.

 

In September 2017, the Company, through its wholly-owned subsidiary VectorVision Ocular Health, Inc., acquired substantially all of the assets and certain liabilities of VectorVision, Inc., a company that specialized in the standardization of contrast sensitivity, glare sensitivity, low contrast acuity, and early treatment diabetic retinopathy study (“ETDRS”) visual acuity testing. In August 2018, the Company created a wholly owned subsidiary, Transcranial Doppler Solutions, Inc. (“TDSI”). The Company has established TDSI operations with selected clinics and is focusing on expanding its client base.

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Although all of the Company’s products and services target the early detection, intervention and monitoring of a range of eye diseases, the addition of potential new products or services as the Company grows requires management to periodically reevaluate its reporting structure. As sales of our medical food as well as sales of VectorVision products grow, there is an increased need for the CODM to evaluate revenue and gross profit on a product line or group basis for purposes of resource allocation. As of June 30, 2019, the TDSI subsidiary does not meet the required quantitative criteria to be considered a reportable operating segment. Additionally, TDSI does not share similar economic characteristics or a majority of the aggregation criteria set forth in ASC 280, and therefore is included in the category “Other” below. The TDSI business earned $6,300 of service revenue during the quarter ended June 30, 2019 and incurred approximately $121,000 of operating costs during the six months ended June 30, 2019. As of June 30, 2019, based on anticipated growth and the expanding diversity of product and service offerings by the Company, management has concluded that results should be reported in two operating segments: Medical Foods and Vision Testing Diagnostics. The following tables set forth our results of operations by segment (results allocated to Other consist of non-cash stock compensation expense, depreciation and amortization, corporate legal fees, and the TDSI operations):

  For the Three Months Ended June 30, 2019 
  Other  Medical Foods  Vision Testing
Diagnostics
  Total 
             
Revenue $6,300  $104,448  $150,222  $260,970 
                 
Cost of goods sold  2,559   40,681   53,816   97,056 
                 
Gross profit  3,741   63,767   96,406   163,914 
                 
Operating expenses  1,594,719   1,175,027   206,362   2,976,108 
                 
Loss from operations $(1,590,978) $(1,111,260) $(109,956) $(2,812,194)

  For the Three Months Ended June 30, 2018 
  Other  Medical Foods  Vision Testing
Diagnostics
  Total 
             
Revenue $-  $79,993  $140,785  $220,778 
                 
Cost of goods sold  -   40,959   46,817   87,776 
                 
Gross profit  -   39,034   93,968   133,002 
                 
Operating expenses  468,630   893,925   85,429   1,447,984 
                 
Loss from operations $(468,630) $(854,891) $8,539  $(1,314,982)

  For the Six Months Ended June 30, 2019 
  Other  Medical Foods  Vision Testing
Diagnostics
  Total 
             
Revenue $6,300  $204,382  $292,826  $503,508 
                 
Cost of goods sold  2,559   78,953   109,036   190,548 
                 
Gross profit  3,741   125,429   183,790   312,960 
                 
Operating expenses  1,959,838   2,003,320   347,219   4,310,377 
                 
Loss from operations $(1,956,097) $(1,877,891) $(163,429) $(3,997,417)

14

  For the Six Months Ended June 30, 2018 
  Other  Medical Foods  Vision Testing
Diagnostics
  Total 
             
Revenue $-  $154,294  $259,524  $413,818 
                 
Cost of goods sold  -   72,238   94,817   167,055 
                 
Gross profit  -   82,056   164,707   246,763 
                 
Operating expenses  1,523,133   2,206,967   163,752   3,893,852 
                 
Loss from operations $(1,523,133) $(2,124,911) $955  $(3,647,089)

The following tables set forth our total assets by segment. Intersegment balances and transactions have been removed:

  As of June 30, 2019 
  Other  Medical Foods  Vision Testing
Diagnostics
  Total 
Current assets                
Cash $13,355  $2,300,973  $54,317  $2,368,645 
Inventories  -   206,876   111,810   318,686 
Other  6,300   129,983   31,943   168,226 
Total current assets  19,655   2,637,832   198,070   2,855,557 
                 
Right to use asset  595,598   -   -   595,598 
Property and equipment, net  -   294,829   9,100   303,929 
Deferred offering  19,000   -   -   19,000 
Intangible assets, net  348,786   -   -   348,786 
Goodwill  1,563,520   -   -   1,563,520 
Other  -   11,751   -   11,751 
                 
Total assets $2,546,559  $2,944,412  $207,170  $5,698,141 

  As of December 31, 2018 
  Other  Medical Foods  Vision Testing
Diagnostics
  Total 
Current assets                
Cash $-  $552,613  $118,335  $670,948 
Inventories  -   235,957   122,040   357,997 
Other  -   44,110   31,866   75,976 
Total current assets  -   832,680   272,241   1,104,921 
                 
Property and equipment, net  -   264,178   10,626   274,804 
Deferred offering  270,000   -   -   270,000 
Intangible assets, net  456,104   -   -   456,104 
Goodwill  1,563,520   -   -   1,563,520 
Other  -   11,751   -   11,751 
                 
Total assets $2,289,624  $1,108,609  $282,867  $3,681,100 

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4.Inventories

Inventories consisted of the following:

  June 30,  December 31, 
  2019  2018 
Raw materials $248,021  $282,574 
Finished goods  70,665   75,423 
  $318,686  $357,997 

5.Property and Equipment, net

Property and equipment consisted of the following:

  June 30,  December 31, 
  2019  2018 
Leasehold improvements $98,357  $98,357 
Testing equipment  300,448   249,447 
Furniture and fixtures  171,121   163,186 
Computer equipment  64,976   64,976 
Office equipment  8,193   8,193 
   643,095   584,159 
Less accumulated depreciation and amortization  (339,166)  (309,355)
  $303,929  $274,804 

For the six months ended June 30, 2019 and 2018, depreciation and amortization expense was $29,810 and $41,243, respectively, of which $0 and $15,376 was included in research and development expense, $19,065 and $4,138 was included in sales and marketing expense, and $10,745 and $21,729 was included in general and administrative expense, respectively.

6.Intangible Assets

The Company’s intangible assets, including finite-lived intangible assets and $50,000 of non-amortizable purchased intellectual property, consisted of the following:

  June 30,  December 31, 
  2019  2018 
Customer relationships $430,700  $430,700 
Technology  161,100   161,100 
Trade Names  115,600   115,600 
Noncompetition  17,000   17,000 
   724,400   724,400 
Less accumulated amortization  (375,614)  (268,296)
  $348,786  $456,104 

The Company’s amortization expense on its finite-lived intangible assets was $107,318 and $107,318 for the six months ended June 30, 2019 and 2018, respectively.

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The Company estimates future amortization expense on its finite-lived intangible assets as of June 30, 2019 to be as follows:

For Years Ended December 31,   
2019 $107,318 
2020  165,320 
2021  16,307 
2022  9,840 
  $298,785 

7.Promissory Notes

Promissory Note

On March 12, 2019, the Company issued a promissory note with principal in the amount of $100,000, simple interest of 10% annually, and with a maturity date of June 10, 2019. On April 11, 2019, the Company repaid the promissory note for a total of $100,548 including accrued interest.

Convertible Notes and Related Warrants

On March 15, 2019, the Company issued a convertible note with principal in the amount of $100,000, simple interest of 5% annually, and with a maturity date of September 30, 2019. In addition, on March 20, 2019, the Company issued a convertible note with principal in the amount of $150,000, simple interest of 5% annually, and with a maturity date of September 30, 2019. The convertible notes (principal and accrued interest) were mandatorily convertible upon the consummation of the IPO. Concurrent with the issuance of the notes, the Company issued warrants to both note holders equal to the number of shares of common stock that the holders receive in connection with the converted notes. The per share exercise price of the warrants was set at 125% of the conversion price of the notes, defined in the note agreements, as the lower of (a) 75% of the price per share of common stock of the IPO or (b) $2.30. The Company determined that it would have to issue 109,038 warrants based upon the completion of the IPO in April 2019

Due to the variable terms of both the exercise price and the number of warrants to be issued, the warrants were accounted for as derivative liabilities at March 31, 2019. The aggregate fair value of the warrants was calculated as $436,034 based on a probability effected Black-Scholes option pricing model with a stock price of $4.00, volatility of 138%, and risk-free rates ranging from 2.34% - 2.39%. The Company recognized a debt discount of $250,000 equal to the face amount of the convertible notes and recorded a financing cost of $186,034 equal to the difference between the fair value of the warrants and the debt discount.

The convertible notes and accrued interest with an aggregate balance of $250,788 were mandatorily converted into 109,038 shares of common stock based on a conversion price of $2.30 per share upon the consummation of the IPO in April 2019.and the valuation discount of $250,000 was recognized as interest cost.

8.Lease Liabilities

In October 2012, the Company entered into a lease agreement for 9,605 square feet of office and warehouse space commencing March 1, 2013. Upon entering into the agreement, the Company paid a deposit of $47,449, of which $36,979 represented prepaid rent. As of June 30, 2019, $11,751 remained on deposit under the lease agreement. The lease (“Lease 1”) was renewed for an additional five years in 2018. As of June 30, 2019, remaining average monthly lease payments under the amended lease agreement were $12,915 through July 2023.

In connection with the VectorVision acquisition on September 29, 2017, the Company assumed a lease agreement for 5,000 square feet of office and warehouse space which commenced on October 1, 2017. The lease (“Lease 2”) was renewed for an additional 65 months. As of June 30, 2019, remaining average monthly lease payments are $1,838 through February 2016,2023.

In accounting for the FASB issued Accounting Standards Update No. 2016-02 (ASU 2016-02), Leases (Topic 842).leases, the Company adopted ASU 2016-02 - Leases, which requires a lessee to record a right-of-use asset and a corresponding lease liability at the inception of the lease initially measured at the present value of the lease payments. The Company classified the leases as operating leases and determined that the fair value of Lease 1 at the inception of the lease was $625,778 using a discount rate of 8.0%. the fair value of Lease 2 at the inception of the lease was $100,742 using a discount rate of 8%. During the six months ended June 30, 2019, the Company made combined payments on both leases of $82,434 towards the balance sheetlease liabilities. As of June 30, 2019 and December 31, 2018, the lease liability for all leases with terms longer than 12 months, as well asLease 1 was $536,672 and $586,082, respectively, and the disclosure of key information about leasing arrangements.lease liability for Lease 2 was $69,703 and $77,137, respectively. 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 classificationCombined rent expense for both leases for the six months ended June 30, 2019 and 2018 was $87,161 and $10,671, respectively. During the six months ended June 30, 2019 and 2018, the Company reflected amortization of all cash payments within operating activities in the statementright of cash flows. Disclosures are required to provide the amount, timinguse asset of $61,571 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 July 2017, the FASB issued Accounting Standards Update No. 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (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 exclude a down round feature when determining whether a financial instrument (or embedded conversion feature) is considered indexed$7,152 related to the entity’s own stock. Asleases, respectively, resulting in a result, financial instruments (or embedded conversion features) with down round features may no longer be required to be accounted fornet asset balance of $595,598 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 2017-11 is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted. The guidance in ASU 2017-11 is to be applied using a full or modified retrospective approach. The adoption of ASU 2017-11 is not currently expected to have any impact on the Company’s financial statement presentation or disclosures.

In June 2018, the FASB issued Accounting Standards Update 2018-07, Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”). ASU 2018-07 expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. ASU 2018-07 also clarifies that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under Revenue from Contracts with Customers (Topic 606). ASU 2018-07 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. The Company will adopt the provisions of ASU 2018-07 in the quarter beginning January 1,30, 2019. The adoption of ASU 2018-07 is not expected to have any impact on the Company’s financial statement presentation or disclosures.

The 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.

 

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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 (the “VectorVision Agreement”). The VectorVision 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. Per the VectorVision Agreement, the 2,800,000 shares were subsequently distributed to the two VectorVision shareholders in proportion to their shareholdings in VectorVision. The shares represented approximately 11% of the Company’s issued and outstanding common stock immediately following consummation of the transaction. The shares held back as security are included in the Company’s 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 expanded the Company’s technical portfolio and the Company believes it further established 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, 2017 and had been included in the Company’s consolidated statements of operations during the three and six-month periods ended June 30, 2017:

13

  Three Months
Ended June 30,
  Six Months
Ended June 30,
 
  2017  2017 
Pro forma net revenues $121,622  $366,793 
Pro forma net loss attributable to common shareholders $(1,088,909) $(1,825,640)
Pro forma net loss per share $(0.04) $(0.06)

4.Inventories

Inventories consisted of the following:

  June 30,  December 31, 
  2018  2017 
Raw materials $380,899  $133,354 
Finished goods  31,458   21,376 
  $412,357  $154,730 

5.Property and Equipment, net

Property and equipment consisted of the following: 

  June 30,  December 31, 
  2018  2017 
Leasehold improvements $98,357  $98,357 
Testing equipment  169,552   150,603 
Furniture and fixtures  145,411   50,300 
Computer equipment  39,476   16,464 
Office equipment  8,193   8,193 
   460,989   323,917 
Less accumulated depreciation and amortization  (269,562)  (228,320)
  $191,427  $95,597 

For the six months ended June 30, 2018 and 2017, depreciation expense was $41,242 and $31,331, respectively, of which $15,376 and $14,650 were included in research and development expense, $4,138 and $0 were included in sales and marketing expense, and $21,728 and $16,861 were included in general and administrative expense, respectively.

6.Acquisition of Intellectual Property

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 third 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 June 30, 2018. The Company will evaluate the status of the assets for impairment annually or more frequently if warranted.

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 conjunction with the consulting agreement, the Company granted 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).

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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 June 30, 2018 and December 31, 2017, the Company had $117,473 and $146,133, respectively, due to related parties.

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 aggregate 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 six months ended June 30, 2017, the Company declared dividends of $67,646 on its Series A Preferred Stock which were satisfied in full through the issuance of an aggregate of 112,759 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 six months ended June 30, 2017, the Company declared dividends of $13,537 on its Series B Preferred Stock which were satisfied in full through the issuance of an aggregate of 18,054 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 Series A Preferred Stock and the Series B 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 Series A Preferred Stock and the Series B Preferred Stock into 6,981,938 shares of common stock (excluding accrued but unpaid dividends) effective November 3, 2017. On April 26, 2018, the Company filed a Certificate of Elimination with the Secretary of the State of Delaware, withdrawing the respective Certificates of Designation that established the right, privileges and preferences of the Series A Preferred Stock and Series B Preferred Stock, thereby making all 10,000,000 authorized shares of preferred stock available for issuance.

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 Company’s securities, subject to customary exceptions. The preemptive rights terminate at the earlier of (i) May 3, 2019, (ii) such time as the Purchasers hold less than five percent (5%) of the issued and outstanding shares of the Company’s common stock, or (iii) such time as the shares of common stock of the Company shall become listed or approved for listing on a national securities exchange.

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Warrants

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

Shares
December 31, 20172,983,666
Granted-
Forfeitures-
Expirations(181,243)
Exercised(146,000)
June 30, 2018, all exercisable2,656,423

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 April 30, 2018, The Company offered a one-month exercise period extension to stockholders who held warrants to purchase shares of common stock of the Company that were scheduled to expire on May 1, 2018. Pursuant to the terms of a Note and Warrant Purchase Agreement entered into by the Company and such holders, such warrants were issued upon the conversion of certain promissory notes into common stock on May 1, 2015. Four of the warrant holders did not extend their warrants, resulting in the expiration of 151,006 warrants on May 1, 2018. Six warrant holders elected to extend the term of an aggregate of 403,085 warrants by one month to June 1, 2018. The exercise price of such warrants is $1.00 per share.

On May 31, 2018, the six warrant holders noted above were offered a further extension of the exercise period for their warrants. One holder did not extend, resulting in the expiration of 30,237 warrants on June 1, 2018. Five warrant holders elected to extend the term of an aggregate of 372,848 warrants. These warrants are now scheduled to expire on the earlier of (a) May 31, 2019 or (b) sixty days following the date on which the common stock of the Company becomes listed or approved for listing on a national securities exchange. The exercise price of such warrants remains unchanged at $1.00 per share, but cashless exercise provisions have been eliminated from such warrants.

Management applied the guidance in ASC 718 – Compensation-Stock Compensation which indicates that a modification to the terms of an award should be treated as an exchange of the original award for a new award with the resulting total compensation cost equal to the grant-date fair value of the original award plus the incremental value of the modification to the award. Under ASC 718, the calculation of the incremental value is based on the excess of the fair value of the new (modified) award based on current circumstances over the fair value of the original award measured immediately before its terms are modified based on current circumstances. The Company recognized expense of $494,391 relating to the extension of the exercise period of the warrants based upon a Black-Scholes option-pricing model using a stock price of $1.15, volatility of 118%, and an average risk-free rate of 2.61. The expense is reflected as Fair value of warrants - extension of expiration dates in the Company’s statements of operations.

As of June 30, 2018, the Company had an aggregate of 2,656,423 outstanding warrants to purchase shares of its common stock with a weighted average exercise price of $0.43, weighted average remaining life of 0.7 years and aggregate intrinsic value of $1,905,475, 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.

16

Stock Options

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

Shares
December 31, 20172,125,000
Granted500,000
Forfeitures-
Exercised-
June 30, 2018, outstanding2,625,000
June 30, 2018, exercisable2,225,000

On September 30, 2017, the Company entered into a consulting agreement pursuant to which the Company granted 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 vest ratably over twelve months on a quarterly basis with compensation cost measured as 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 5 years from the grant date. As of December 31, 2017, the Company had recognized compensation cost of $658,383 relating to the vesting of 800,000 options. During the six months ended June 30, 2018, the Company recognized stock compensation costs of $256,962 related to the vesting of 450,000 options based upon a graded vesting schedule. As of June 30, 2018, the remaining 150,000 options to vest were valued at $172,388 based upon a Black-Scholes option-pricing model.

On December 30, 2017, the Company entered into a consulting agreement pursuant to which the Company granted 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 500,000 options vested ratably over six months on a quarterly basis with compensation cost measured as the fair value at the end of each reporting period, using a Black Scholes option-pricing model and a graded vesting schedule. The options are non-qualified, have an exercise price of $1.25 per share, and will expire 5 years from the grant date. As of June 30, 2018, all options were fully vested. During the six months ended June 30, 2018, the Company recognized stock compensation costs of $413,877 related to these options.

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 granted 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. As of June 30, 2018, the 250,000 options that remain to vest were valued in total at $287,365 based upon a Black-Scholes option-pricing model. Compensation cost is measured as the fair value at the end of each reporting period and cost is amortized based upon a graded vesting schedule. The options are non-qualified, have an exercise price of $1.25 per share, and will expire 5 years from the grant date. During the six months ended June 30, 2018, the Company recognized stock compensation costs of $384,046 related to these options.

As of June 30, 2018, options were valued based upon the Black-Scholes option-pricing model, with a stock price of $1.15, volatility of 120%, and an average risk-free rate of 2.65%.

As of June 30, 2018, the Company had an aggregate of 400,000 remaining unvested options outstanding, with estimated fair value of $459,754. The Company remeasures unvested options for non-employees to fair value at the end of each reporting period. The aggregate intrinsic value of options outstanding as of June 30, 2018 was $187,500.

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 June 30, 20182019 with respect to such matters, includingmatters.

10.Stockholders’ Equity (Deficit)

Warrants

A summary of the matter noted below.Company’s warrant activity is as follows:

  Shares  

Weighted
Average

Exercise

Price

  Weighted
Average
Remaining
Contractual
Term (Years)
 
December 31, 2018  1,265,674   0.71   0.29 
Granted  171,538   2.39   3.11 
Forfeitures  -   -   - 
Expirations  (279,424)  (1.96)  - 
Exercised  (896,250)  (1.88)  - 
June 30, 2019, all exercisable  261,538  $2.81   3.35 

The exercise prices of warrants outstanding and exercisable as of June 30, 2019 are as follows:

Warrants Outstanding and Exercisable (Shares)  Exercise Prices 
 25,000  $0.50 
 65,000   1.50 
 109,038   2.88 
 62,500   5.00 
 261,538     

Between February 11, 2019 and May 21, 2019, investors net exercised a total of 632,500 warrants for 492,256 shares of common stock on a cashless basis.

Between February 11, 2019 and May 21, 2019, investors exercised warrants for 263,750 shares of common stock. The warrants were exercisable for $0.50 per share, and the Company received $131,875 in cash.

As of June 30, 2019, the Company had an aggregate of 261,538 outstanding warrants to purchase shares of its common stock with a weighted average exercise price of $2.81, a weighted average remaining life of 3.35 years and an aggregate intrinsic value of $19,000, based upon a stock valuation of $1.26 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.

 

 1718 

 

 

On or about July 26, 2017,Warrant liability

In March 2019, the Company received a payment demand from a former consultantissued warrants to two convertible note holders pursuant to the anticipated completion of the Company’s IPO (the IPO was completed on April 9, 2019). Due to the variable terms of both the exercise price and the number of warrants to be issued, the warrants were accounted for as derivative liabilities at March 31, 2019. At March 31, 2019, the Company allegingestimated that the consultant is owed approximately $192,000issuance of 109,038 warrants with an exercise price of $2.88 per share would correspond to the number of shares of common stock that the holders would receive in connection with the completion of the IPO.. The fair value of the warrants at the closing of the IPO was determined to be $359,683 using a Black-Scholes model with a weighted average remaining life of 4.94 years and a stock valuation of $3.30 per share. Upon completion of the IPO, the exercise price and the number of warrants were fixed and the warrants no longer accounted for services rendered.as liabilities. As such the fair value of the warrant liability of $359,683 was reclassified to equity.

On April 4, 2019, the Company issued 62,500 warrants with an exercise price of $5.00 per share to the underwriter (the “Underwriter”) in connection with the Company’s IPO. The Company has disputed this demandaccounted for these warrants as a derivative liability in the financial statements at June 30, 2019 because they were associated with the IPO, a registered offering, and attemptsthe settlement provisions contained language that the shares underlying the warrants are required to resolve this matter were unsuccessful. On January 29, 2018,be registered. The fair value of the warrants is remeasured at each reporting period, and the change in the fair value is recognized in earnings in the accompanying Statements of Operations. The fair value of the warrants at the date of issuance was determined to be $229,291 and was recorded as a finance cost. As of June 30, 2019, the fair value of the warrants was determined to $78,440.

The fair value of the warrant liability was determined at the following issuance and reporting dates using the Black-Scholes-Merton option pricing model and the following assumptions:

  Convertible Noteholders  Underwriter  

Warrant Liability As of

 
  Upon Issuance  Upon Issuance  June 30,2019 
Stock price $4.00  $3.68  $1.26 
Risk free interest rate  2.34 – 2.39%  2.29%  1.71%
Expected volatility  138%  137%  145%
Expected life in years  5.00   5.00   4.76 
Expected dividend yield  0%  0%  0%
Number of warrants  109,038   62,500   62,500 
Fair value of warrants $436,034  $229,921  $78,440 

Stock Options

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

  Shares  

Weighted

Average
Exercise Price

  Weighted Average Remaining Contractual Term (Years) 
December 31, 2018  1,362,500   2.26   3.78 
Granted  1,250,000   2.11   2.29 
Forfeitures  -   -   - 
Expirations  -   -   - 
Exercised  -   -   - 
June 30, 2019, outstanding  2,612,500  $3.28   4.00 
June 30, 2019, exercisable  1,391,667  $2.41   3.46 

19

The exercise prices of options outstanding and exercisable as of June 30, 2019 are as follows:

Options Outstanding

(Shares)

  

Options Exercisable

(Shares)

  Exercise Prices 
 625,000   625,000  $2.00 
 62,500   62,500   2.30 
 675,000   600,000   2.50 
 1,250,000   104,167   4.40 
 2,612,500   1,391,667     

During the six months ended June 30, 2019, the Company filedgranted options to purchase 1,250,000 shares of common stock to the Company’s Chairman and CEO with a lawsuit againstgrant date fair of $4,122,750. The options will vest on a quarterly basis over three years. The Company accounts share-based payments to employees in accordance with ASC 718 wherein grants are measured at the consultantgrant date fair value and its related entitiescharged to operations over the vesting period. During the period ended June 30, 2019, compensation cost of $1, 066,159 was recognized during the period relating the amortization of this award.

During the period ended June 30, 2019, option awards were valued based upon the Black-Scholes option-pricing model, with stock price ranging from $3.30 to $4.00 per share, volatility ranging from 115% to 138%, and an average risk-free rate ranging from 2.31% to 2.46%.

During the six months ended June 30, 2019 and 2018, we recognized aggregate stock-compensation expense of $1,309,155 and $1,054,885, respectively, based upon stock prices ranging from $3.30 to $4.00 per share, all of which was recorded in the United States District Court for the Southern Districtgeneral and administrative expense.

As 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 againstJune 30, 2019, the Company seeking payment for services renderedhad an aggregate of 1,220,833 remaining unvested options outstanding, with a total estimated fair value of $3,132,532, weighted average exercise price of $4.28, and seeking declaratory relief regarding ownership interest in the Company.weighted average remaining life of 4.61 years. The Company intends to vigorously defend its rights. The Company cannot predict the outcomeaggregate intrinsic value of this matter.options outstanding as of June 30, 2019 was $0.

 

10.11.Subsequent EventsRelated Party Transactions

 

On July 25,During the six months ended June 30, 2019 and 2018, the Company incurred and paid $150,000 and 137,500, respectively, of salary expense to our Board Chairman and CEO, Mr. Michael Favish. In addition, compensation cost of Directors approved the Company entering into a product development consulting agreement with a product development company to design and create a working prototype device, named AcQviz, intended to embody the inventions described in US Patent No. 10,022,045 and US Patent Application 15/277,849, each$1,066,159 was recognized on amortization of which the Company owns. Under this agreement, the product development company is to create a prototype device using sensor circuitry and communication software/firmware unique to the product development company, oversee the integration of the prototype circuitry design into a commercial product, develop specifications for the Company to mass produce a commercial product based on the prototype and integrate the communication channel for the device into various vision testing software programs. In conjunction with the product development agreement, the Board of Directors of the Company also approved a stock option grant toawards during the product development company to purchase 100,000 shares of the common stock of the Company based on certain performance metrics set forth in the product development agreement and stock option agreement. The President of the product development company, Joseph Tate Evans, Jr., is the brother of David Evans, Chief Science Officer and a director of the Company.period ended June 30, 2019.

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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 and our audited financing statements for the year ended December 31, 2017,2018, and the notes thereto, which are set forth in the 20172018 Form 10-K. All dollar amounts refer to U.S. dollars unless otherwise indicated.

 

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Overview

 

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

 

We areThe Company is a specialty health sciences company that develops, formulatesformed to develop, formulate and distributesdistribute 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-based diseases such as age-related macular degeneration (“AMD”), computer vision syndrome (“CVS”) and diabetic retinopathy. The Company believes this risk may be modified by taking Lumega-Z to maintain a healthy macular protective pigment. Additional research has also shown a depleted macular protective pigment to be a biomarker for neurodegenerative diseases such as Alzheimer’s disease and dementia. We have had limited operations to date, and have primarily been engaged in research, product development, commercialization and capital raising.

 

We have also developedThe Company invented a proprietary technology, embodied in the Company’s 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 USPTOUnited States Patent and Trademark Office (“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 measuremeasures 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 medical 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.

 

In September 2017, the Company, through its wholly-owned subsidiary VectorVision Ocular Health, Inc. (“VectorVision”), acquired substantially all of the assets and certain liabilities of VectorVision, Inc., a company that specializesspecialized in the standardization of contrast sensitivity, glare sensitivity, low contrast acuity, and early treatment diabetic retinopathy study (“ETDRS”) visual acuity testing. VectorVision’s standardization system is 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 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 expandsexpanded the Company’s technical portfolioportfolio. CSV-1000 and CSV-3000 instruments offer auto-calibrated tests to ensure correct testing luminance and contrast levels for consistent, highly accurate and repeatable results. Recently issued patents the Company received for continuously calibrating the light source will be incorporated into the new CSV-2000, in which the proprietary standardized contrast sensitivity test patterns can be presented to the patient using a computer monitor as opposed to the current calibrated backlit system. The Company believes itthe acquisition of VectorVision further establishes its position at the forefront of early detection, intervention and monitoring of a range of eye diseases.

In August 2018, the Company created a wholly owned subsidiary, Transcranial Doppler Solutions, Inc. (“TDSI”). TDSI is dedicated to the pursuit of early predictors resulting in, the Company believes, valuable therapeutic intervention for practitioners and their patients, and additional revenue streams generated from the testing and sale of Company products to appropriate customers. The Company has established operations with selected clinics and is focusing on expanding its client base.

In November 2018, the Company launched a new medical food product, GlaucoCetinTM, which the Company believes is the first vision-specific medical food designed to support and protect the mitochondrial function of optic nerve cells and improve blood flow in the ophthalmic artery in patients with glaucoma. The Company believes GlaucoCetinTM is the first vision-specific medical food designed to support and protect the mitochondrial function of optic nerve cells and improve blood flow in the ophthalmic artery in patients with glaucoma. The parent compound of GlaucoCetinTM, called “GlaucoHealth,” was designed by Robert Ritch, M.D., one of the Company’s Medical Advisory Board members. Dr. Robert Ritch holds the Shelley and Steven Einhorn Distinguished Chair in Ophthalmology and is surgeon Director Emeritus and Chief of Glaucoma Services at the New York Eye and Ear Infirmary. Dr. Ritch has devoted his career to broadening the understanding of the underlying etiologies and mechanisms of glaucoma. The Company now owns the GlaucoHealth formula.

The Company has had limited operations to date and has been primarily engaged in research and development, product commercialization and capital raising activities.

 

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.

 

 1921 

 

Recent Developments

 

Development of Sales ForceRecent Developments

 

The Company entered into an agreement with a third party in March 2018 to provide a direct sales force 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 travel 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 physician 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. During the second quarter of 2018, the Company hired three members of the sales team as employees of Guardion and cancelled the agreement with the third party sales organization.

PatentsInitial Public Offering

 

On July 10, 2018,April 9, 2019, the USPTO issued US Patent No. 10,016,128, titled MethodCompany closed its initial public offering (the “IPO”) of 1,250,000 shares of common stock, par value $0.001 per share, at an IPO price to the public of $4.00 per share resulting in net proceeds to the Company of $3,888,000 after all costs and Apparatusexpenses. The shares began trading on the NASDAQ Capital Market on April 5, 2019 under the symbol “GHSI.”

Products

Lumega-Z has been used in IRB-approved patient studies to examine its effectiveness. On May 9, 2019, the Company announced in a press release a recent study that showed statistically significant improvement in visual function (“CSF”) of patients taking Lumega-Z who participated in the study. The study was conducted by research scientists at the Western University College of Optometry to evaluate the visual benefits of Lumega-Z in one group of patients as compared to a group of patients taking AREDS 2 soft gel supplements. Each patient has retinal drusen and is at risk of developing AMD. The results of the study were presented at the Association for Visual Acuity Testing. ThisResearch in Vision and Ophthalmology (“ARVO”) 2019 annual meeting and showed improvements in visual function (“CSF”) in the group of patients taking Lumega-Z that were statistically significant and definitive. The patients taking AREDS 2 showed no statistical change.

On June 4, 2019, the Company announced in a press release that the parent compound of the GlaucoCetinTM formula was used in an IRB-approved patient study conducted at the New York Eye and Ear Infirmary and successfully reversed mitochondrial dysfunction in the optic nerve cells in patients with glaucoma. GlaucoCetinTM is an enhanced formulation of GlaucoHealth. The Company owns both formulas and has a patent application pending on the GlaucoCetinTM formula. The application describes an invention pertaining to automatic light calibrationthat provides a micro-nutrient composition for a human subject suffering from a glaucomatous disease, wherein the micro-nutrient composition comprises a formulation for reversing mitochondrial dysfunction in glaucomatous disease.

Patents

On July 16, 2019, the Company was notified by the Patents Registry in Hong Kong that it has received a patent from the Government of the display screens usedHong Kong Special Administrative Region (Hong Kong Patent No. HK1204758 titled “Apparatus for vision testing. TheUse in the Measurement of Macular Pigment Optical Density and/or Lens Optical Density of an Eye”) for the MapcatSF®.

On May 30, 2019, the Company owns thiswas notified by the European Patent Office that it has received a patent and its VectorVision CSV-1000 and ESV-3000 devices each embody this invention.from the European Union (European Patent No. 2,811,892 titled “Apparatus for Use in the Measurement of Macular Pigment Optical Density and/or Lens Optical Density of an Eye”) for the MapcatSF®.

Trademarks

 

On July 17,April 25, 2019, the Company was notified by the State Intellectual Property Office of the People’s Republic of China (“China”) that the Company has been granted trademark registrations in China for its proprietary medical food, Lumega-Z (Registration No. 27151643), and for its proprietary and patented medical device, the MapcatSF (Registration No. 27151644). The trademark registration for the mark LUMEGA-Z is effective from November 7, 2018 to November 6, 2028. The trademark registration for the USPTO issued US Patent No. 10,022,045, also titled Method and Apparatus for Visual Acuity Testing, which describes a methodologymark MAPCAT SF is effective from October 28, 2018 to continuously calibrate display monitors to automatically hold display luminance constant for vision testing. This second patent also covers a methodology to compensate for other testing factors, such as room illumination and when patients view the vision test through a mirror, which is a common practice in eye doctors’ offices worldwide. The Company also owns this patent, and its VectorVision CSV-1000 and ESV-3000 devices each embody this invention.October 27, 2028.

 

These patents serve as the basis for developing follow-on products to the CSV-1000, the CSV-2000, in which the proprietary standardized contrast sensitivity test patterns can be presented to the patient using a computer monitor as opposed to the current calibrated backlit system. The Company also anticipates commercializing these proprietary methodologies for use with other types of vision tests so that other tests can be properly calibrated to adhere to recognized government vision test lighting standards.

Prior to the issuance of US Patent No. 9,486,136, the Company 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 device, as well as updated features around photodiode detector calibrations.

Going Concern

 

The financial statements have been prepared assuming the Company will continue as a going concern. The Company had a net loss of $4,143,025$4,437,177 and utilized cash in operating activities of $2,424,058$2,493,696 during the six months ended June 30, 2018.2019. 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.

 

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The Company’s independent registered public accounting firm has also included explanatory language in their opinion accompanying the Company’s audited financial statements for the year ended December 31, 2017.2018. 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 Lumega-Z, the MapcatSF®medical device, VectorVision products, the TDSI business and VectorVision products.with respect to efforts to continue to build the Company’s infrastructure. 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 or product lines. On April 9, 2019, the Company completed the IPO, resulting in net cash proceeds of $3,888,000 to the Company. The Company is continuing to attemptseeking 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.

 

20

Reverse Stock Split

 

On January 30, 2019, following stockholder and Board approval, the Company filed a Certificate of Amendment to its Amended Certificate of Incorporation, as amended (the “Amendment”), with the Secretary of State of the State of Delaware to effectuate a one-for-two (1:2) reverse stock split (the “Reverse Stock Split”) of its common stock, par value $0.001 per share, without any change to its par value. The Amendment became effective on the filing date. The number of shares authorized for common and preferred stock were not affected by the Reverse Stock Split. No fractional shares were issued in connection with the Reverse Stock Split as all fractional shares were “rounded up” to the next whole share. Proportional adjustments for the Reverse Stock Split were made to the Company’s outstanding common stock, stock options, and warrants as if the split occurred at the beginning of the earliest period presented.

Recent Accounting Pronouncements

 

See Note 2 to the condensed consolidated financial statements for managements’the period ended June 30, 2019 for management’s discussion of recent accounting pronouncements.

 

Concentration of Risk

Cash balances are maintained at large, well-established financial institutions. At times, cash balances may exceed federally insured limits. Insurance coverage limits are $250,000 per depositor at each financial institution. The Company has never experienced any losses related to these balances.

Critical Accounting Policies and Estimates

 

The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The preparation of its 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. The Company’s financial statements included herein include all adjustments, consisting of only normal recurring adjustments, necessary to present fairly itsthe Company’s 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 the Company’s financial statements.

 

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Intangible Assets

 

In connection with the VectorVision transaction, the Company 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, the Company determined whether these assets are expected to have indefinite (such as goodwill) or limited useful lives, and for those with limited lives, the Company established an amortization period and method of amortization. The Company’s goodwill and other intangible assets are subject to periodic impairment testing.

 

The Company utilized the services of an independent third-party valuation firm to assist it in identifying intangible assets and in estimating their fair values. The useful lives for its 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, identifiableall intangible assets and goodwill for impairment at each fiscal year end or when events or changes in circumstances indicate that their carrying values may not be recoverable. If 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 togroup is not recoverable, 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,Company recognizes an impairment charge is recognizedloss for the amount by which theexcess carrying amount of the asset exceedsvalue over the fair value in its consolidated statements 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.operations. As of June 30, 20182019 and December 31, 2017,2018, the Company had not deemed any long-lived assets as impaired and was not aware of the existence of any indicators of impairment of its intangibles at such dates.

 

Goodwill

Goodwill represents the excess of the purchase consideration over the fair value of the net tangible and identifiable intangible assets acquired in a business combination. The Company evaluates goodwill for impairment on an annual basis or whenever events and changes in circumstances suggest that the carrying amount may not be recoverable. The Company conducts its annual impairment analysis in the beginning of the fourth quarter of each fiscal year. Impairment of goodwill is tested at the reporting unit level by comparing the reporting unit’s carrying amount, including goodwill, to the fair value of the reporting unit. Estimations and assumptions regarding the number of reporting units, future performances, results of the Company’s operations and comparability of its market capitalization and net book value will be used. If the carrying amount of the reporting unit exceeds its fair value, goodwill is considered impaired and an impairment loss is measured by the resulting amount. As of June 30, 2019 and December 31, 2018, the Company was not aware of the existence of any indicators of impairment of its goodwill at such dates.

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.

 

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Stock-based payments to officers, directors, consultants, contractors, and 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.

 

TheIn prior periods, the Company accountsaccounted 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. On January 1, 2019, the Company adopted Accounting Standards Update (ASU) 2018-07 which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. Non-employee stock-based compensation charges generally are amortized over the vesting period using a graded 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.

24

 

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 in determining the value of the Company. The third-party valuation firm’s input was utilized in determining the related per unit or share valuations of the Company’s equity used during 2017. Management used a valuation of $0.88 per share for the six months ended June 30, 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:

  Six Months Ended 
  June 30, 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 commonpreferred stock sales, Management used a valuation of $1.15 for accounting purposes during the first six months ended June 30,of 2018. Management used a valuation $4.00 for the first quarter of 2019. Management considered business and market factors affecting the Company during the six-monththese periods, ended June 30, 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 shareits valuations are appropriate for accounting purposes at June 30, 2018 and 2017, respectively.during these periods. Closing prices of our common stock ranging from $1.26 to $3.30 were used in our fair value calculations during the second quarter of 2019.

 

The Company recognizes stock compensation expense, on stock 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 over the price paid for the 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.

 

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Plan of Operations

 

General Overview

 

Based on the availability of sufficient funding, the Company intends to increase its commercialization activities and:

 

·Furtherfurther the commercial production of the MapcatSF, starting with the manufacture of at least 15 new units for sale or lease;MapcatSF;
·Expandexpand the Company’s domestic sales and marketing efforts, which include revamping its web site and new promotional materials;efforts;
·Exploreexplore sales and marketing opportunities in foreign markets such as Asia and Europe;
·Increaseincrease production of Lumega-Z as is necessaryand GlaucoCetinTM 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;
·Increase the Company’sincrease focus on intellectual property protection and strategy;
·Expandexpand the sales and marketing of itsthe VectorVision product line;
develop the TDSI business and operations; and
·Exploreexplore 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. The Company is in discussions with its 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 company 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, the Company expects to complete applicable IEC 60601-1 testing prior to commercialization because the Company believes in marketing a product that has evidence that it is safe and effective.

 

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Results of Operations

 

Through June 30, 2018,2019, the Company had limited operations and has primarily been engaged in research andproduct development, product commercialization, and raising capital. The Company has incurred and will continue to incur significant expenditures for the development of its 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 six-month periodssix months ended June 30, 20182019 and 2017. In the fourth quarter of 2017, the Company began recognizing product revenue from the sale of VectorVision products in addition to sales of its proprietary product, Lumega-Z.2018.

 

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Comparison of Three Months Ended June 30, 20182019 and 20172018

 

 Three Months Ended June 31,     

Three Months Ended

June 30,

   
 2018  2017  Change  2019  2018  Change 
Revenue $220,778  $59,977  $160,801   268% $260,970  $220,778  $40,192   18%
Cost of goods sold  87,776   29,692   58,084   196%  97,056   87,776   9,280   11%
Gross Profit  133,002   30,285   102,717   339%  163,914   133,002   30,912   23%
Operating Expenses:                                
Research and development  34,320   15,530   18,790   121%  77,688   34,320   43,368   126%
Sales and marketing  378,750   101,598   277,152   273%  409,409   378,750   30,659   8%
General and administrative  1,034,914   766,894   268,020   35%  2,489,011   1,034,914   1,454,097   141%
Total Operating Expenses  1,447,984   884,022   563,962   64%  2,976,108   1,447,984   1,528,124   106%
Loss from Operations  (1,314,982)  (853,737)  (461,245)  54%  (2,812,194)  (1,314,982)  (1,497,212)  114%
Other Expense:                                
Interest expense  710   1,924   (1,214)  (63)%  234,065   710   233,355   32,867%
Fair value of warrants - extension of expiration dates  494,391   -   494,391   -%
Finance cost upon issuance of warrants  229,921   -   229,921   100%
Change in fair value of derivative warrants  (227,832)  -   (227,832)  100%
Costs associated with extension of warrant expiration dates  -   494,391   (494,391)  (100)%
Net Loss $(1,810,083) $(855,661) $(954,422)  112% $(3,048,348) $(1,810,083) $(1,238,265)  68%

 

Revenue

 

For the three months ended June 30, 2018,2019, revenue from product sales was $220,778$260,970 compared to $59,977$220,788 for the three months ended June 30, 2017,2018, resulting in an increase of $160,801$40,192 or 268%18%. The increase reflects both an increased customer base for Lumega-Z as the Company expands into new clinics and increased sales of VectorVision products. $79,993, or 36% ofThe Company also earned $6,300 in revenue infrom its TDSI business during the second quarter of 2018 was generated by sales of Lumega-Z products, representing a 33% increase in Lumega-Z sales over the prior period. As ofthree months ended June 30, 2018, the Company had a sales backlog of approximately $89,000 in VectorVision products, all of which were delivered and recognized as revenue in July.2019.

 

The following table presents the Company’s revenues disaggregated by product type:

  

Three Months Ended

June 30,

 
  2018  2017 
Lumega-Z and supplements $79,993  $59,977 
VectorVision medical devices and supplies  140,785   - 
  $220,778  $59,977 

Cost of Goods Sold

 

For the three months ended June 30, 2018,2019, cost of goods sold was $87,776$97,056 compared to $29,692$87,776 for the three months ended June 30, 2017,2018, resulting in an increase of $58,084$9,280 or 196%11%. The increase reflects the additional sales recorded in 2018.

 

Gross Profit

 

For the three months ended June 30, 2018,2019, gross profit was $133,002$163,914 compared to $30,285$133,002 for the three months ended June 30, 2017,2018, resulting in an increase of $102,717$30,912 or 339%23%. Gross profit represented 63% of revenues the three months ended June 30, 2019, versus 60% of revenue for the three months ended June 30, 2018. The increase isin gross profit in 2019 was due primarily due to the sales of VectorVision products, which did not occurpricing and product mix changes in the prior period.2019.

 

Research and Development

 

For the three months ended June 30, 2018,2019, research and development costs were $34,320$77,688 compared to $15,530$34,320 for the three months ended June 30, 2017,2018, resulting in an increase of $18,790$43,368 or 121%126%. The increase was due to researchengineering development costs associated with the Company’s MapcatSF® medical device.CSV-2000 product in 2019.

 

26

Sales and Marketing

 

For the three months ended June 30, 2018,2019, sales and marketing expenses were $378,750$409,409 compared to $101,598$378,750 for the three months ended June 30, 2017.2018. The increase in sales and marketing expenses of $277,152$30,659 or 273% compared to the prior period was due to costs associated with engagement of a third party national sales team, as well as an increased presence at trade shows.

24

General and Administrative

For the three months ended June 30, 2018, general and administrative expenses were $1,034,914 compared to $766,894 for the three months ended June 30, 2017. The increase of $268,020 or 35%8% compared to the prior period was primarily due to increased labor, legal,trade show costs and consulting costs duringfees in the period.current quarter.

 

Interest ExpenseGeneral and Administrative

 

For the three months ended June 30, 2018, interest expense was $7102019, general and administrative expenses were $2,489,011 compared to $1,924$1,034,914 for the three months ended June 30, 2017.2018. The decreaseincrease of $1,214,$1,454,097 or 63%,141% compared to the prior period was primarily due to an increase in non-cash stock compensation costs during the current period of approximately $976,000. Additionally, expenses for corporate insurance, investor relations, labor, legal and professional fees, and travel have increased versus the prior period.

Interest Expense

For the three months ended June 30, 2019, interest expense was $234,065 compared to $710 for the three months ended June 30, 2018. The increase of 233,355 compared to the prior period was due primarily to the repayment or conversionamortization of all promissorythe valuation discount of the March 2019 convertible notes and convertible debtof $233,455 that had been outstanding during 2017.was reflected as an expense when the notes were converted. There were no such costs for the comparable period in 2018.

 

Finance Cost Upon Issuance of Warrants

Finance costs for the three months ended June 30, 2019 were $229,921.There were no such costs for the comparable period in 2018. On April 4, 2019, the Company issued 62,500 warrants with an exercise price of $5.00 per share to the underwriter (the “Underwriter”) in connection with the Company’s IPO. The Company accounted for these warrants as a derivative liability in the financial statements at June 30, 2019 because they were associated with the IPO, a registered offering, and the settlement provisions contained language that the shares underlying the warrants are required to be registered. The fair value of the warrants at the date of issuance was determined to be $229,291 and was recorded as a finance cost.

Change in Fair Value of Derivative Warrants

The change in fair value of the derivative warrant liability was a decrease of $227,832 for the three months ended June 30, 2019.There were no such costs for the comparable period in 2018.In March 2019, the Company issued warrants to two convertible note holders pursuant to the anticipated completion of the Company’s IPO (the IPO was completed on April 9, 2019). Due to the variable terms of both the exercise price and the number of warrants to be issued, the warrants were accounted for as derivative liabilities at March 31, 2019 with a fair value of $436,034. Upon completion of the IPO on April 9, 2019, the exercise price and the number of warrants were fixed and the warrants no longer accounted for as liabilities. As such the fair value of the warrant liability of $359,683 was reclassified to equity and the remaining liability of $76,351 was recorded as a change in fair value of derivative liabilities in the Statements of Operations.

On April 4, 2019, the Company issued 62,500 warrants with an exercise price of $5.00 per share to the Underwriter in connection with the Company’s IPO. The Company accounted for these warrants as a derivative liability in the financial statements at June 30, 2019 because they were associated with the IPO, a registered offering, and the settlement provisions contained language that the shares underlying the warrants are required to be registered. The fair value of the warrants will be remeasured at each reporting period, with the change in the fair value recognized in earnings in the accompanying Statements of Operations. The fair value of the warrants at the date of issuance was determined to be $229,291 and was recorded as a finance cost. As of June 30, 2019, the fair value of the warrant liability was determined to be $78,440 and the Company recorded a change in fair value of derivative warrants of $151,481 in the Statements of Operations.

27

Costs associated with extension of warrant expiration dates

 

During April and May of 2018, the Company offered exercise period extensions to stockholders who held warrants to purchase shares of common stock of the Company that were scheduled to expire on May 1, 2018. The Company recognized expense of $494,391 relating to the extension of the exercise period of the warrants using a Black-Scholes option-pricing model to estimate fair value.

 

Net Loss

 

For the three months ended June 30, 2018,2019, the Company incurred a net loss of $1,810,083,$3,048,348, compared to a net loss of $855,661$1,810,083 for the three months ended June 30, 2017.2018. The increase in net loss of $954,422$1,238,265 or 112%68% compared to the prior year period was primarily due to an increase in non-cash stock compensation costs of approximately $976,000. In addition, engineering costs as well as corporate operating expenses increased during the current period.

Segment Information

As of June 30, 2019, Management reported its operating results in two operating segments: Medical Foods, and Vision Testing Diagnostics. As of June 30, 2019, the TDSI subsidiary does not meet the required quantitative criteria to be considered a reportable operating segment.

i.Medical Foods – Our Medical Foods segment develops, formulates and distributes 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. We have also invented a proprietary technology, embodied in a medical device, the MapcatSF,®that accurately measures the macular pigment optical density (“MPOD”). 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 Company has also developed a new medical food product, GlaucoCetinTM, which the Company believes is the first vision-specific medical food designed to support and protect the mitochondrial function of optic nerve cells and improve blood flow in the ophthalmic artery in patients with glaucoma. GlaucoCetinTM combines a unique set of ingredients, specifically designed to stop or potentially reverse the underlying cause of optic nerve loss, and ultimately vision loss, in patients with glaucoma.
ii.Vision Testing Diagnostics – Our Vision Testing Diagnostics segment, under the brand name VectorVision, specializes in the standardization of contrast sensitivity, glare sensitivity, low contrast acuity, and early treatment diabetic retinopathy study (“ETDRS”) visual acuity testing. VectorVision’s standardization system is 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 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 following tables set forth our results of operations by segment (results allocated to Other consist of non-cash stock compensation expense, depreciation and amortization, corporate legal fees, and the TDSI operations):

  For the Three Months Ended June 30, 2019 
  Other  Medical Foods  Vision Testing
Diagnostics
  Total 
             
Revenue $6,300  $104,448  $150,222  $260,970 
                 
Cost of goods sold  2,559   40,681   53,816   97,056 
                 
Gross profit  3,741   63,767   96,406   163,914 
                 
Operating expenses  1,594,719   1,175,027   206,362   2,976,108 
                 
Loss from operations $(1,590,978) $(1,111,260) $(109,956) $(2,812,194)

28

  For the Three Months Ended June 30, 2018 
  Other  Medical Foods  Vision Testing
Diagnostics
  Total 
             
Revenue $-  $79,993  $140,785  $220,778 
                 
Cost of goods sold  -   40,959   46,817   87,776 
                 
Gross profit  -   39,034   93,968   133,002 
                 
Operating expenses  468,630   893,925   85,429   1,447,984 
                 
Loss from operations $(468,630) $(854,891) $8,539  $(1,314,982)

For the three months ended June 30, 2019, revenue from our Medical Foods segment was $104,448 compared to $79,993 for the three months ended June 30, 2018, resulting in an increase of $24,455 or 31%. The increase reflects an increased customer base for Lumega-Z as the Company expands into new clinics. For the three months ended June 30, 2019, revenue from our Vision Testing Diagnostics segment was $150,222 compared to $140,785 for the three months ended June 30, 2018, resulting in an increase of $9,437 or 7%. The increase was due to increased distributor sales in 2019. The Company also earned $6,300 in diagnostic imaging services revenue from its TDSI business during the three months ended June 30, 2019, as shown in the Other category above.

Cost of Goods Sold

For the three months ended June 30, 2019, cost of goods sold from our Medical Foods segment was $40,681 compared to $40,959 for the three months ended June 30, 2018, resulting in a decrease of $278 or 1%. For the three months ended June 30, 2019, cost of goods sold from our Vision Testing Diagnostics segment was $53,816 compared to $46,817 for the three months ended June 30, 2018, resulting in an increase of $6,999 or 15%. The increase for both segments reflects the additional sales recorded in 2018.

Gross Profit

For the three months ended June 30, 2019, gross profit from the Medical Foods segment was $63,767 compared to $39,034 for the three months ended June 30, 2018, resulting in an increase of $24,733 or 63%. For the three months ended June 30, 2019, gross profit from the Vision Testing Diagnostics segment was $96,406 compared to $93,968 for the three months ended June 30, 2018, resulting in an increase of $2,438 or 3%. The increase is due to the non-cash expense relatedadditional sales recorded for both segments in the current year. Gross profit overall represented 63% of revenues for the three months ended June 30, 2019, versus 60% of revenue for the three months ended June 30, 2018. The increase in 2019 was due increased sales and to the extension of warrant expiration dates, as well as to the increased costs associated with the sales team, legal expenses,pricing and its internal labor force.product mix changes in 2019.

 

Comparison of Six Months Ended June 30, 20182019 and 20172018

 

 Six Months Ended June 31,     

Six Months Ended

June 30,

   
 2018  2017  Change  2019  2018  Change 
Revenue $413,818  $115,912  $297,906   257% $503,508  $413,818  $89,690   22%
Cost of goods sold  167,055   52,326   114,729   219%  190,548   167,055   23,493   14%
Gross Profit  246,763   63,586   183,177   288%  312,960   246,763   66,197   27%
Operating Expenses:                                
Research and development  194,708   25,770   168,938   656%  106,716   194,708   (87,992)  (45)%
Sales and marketing  984,464   178,333   806,131   452%  764,028   984,464   (220,436)  (22)%
General and administrative  2,714,680   1,365,807   1,348,873   99%  3,439,633   2,714,680   724,953   27%
Total Operating Expenses  3,893,852   1,569,910   2,323,942   148%  4,310,377   3,893,852   416,525   11%
Loss from Operations  (3,647,089)  (1,506,324)  (2,140,765)  142%  (3,997,417)  (3,647,089)  (350,328)  10%
Other Expense:                                
Interest expense  1,545   18,355   (16,810)  (92)%  251,637   1,545   250,092   16,187%
Fair value of warrants - extension of expiration dates  494,391   -   494,391   -%
Finance cost upon issuance of warrants  415,955   -   415,955   100%
Change in fair value of derivative warrants  (227,832)  -   (227,832)  100%
Costs associated with extension of warrant expiration dates  -   494,391   (494,391)  (100)%
Net Loss $(4,143,025) $(1,524,679) $(2,618,346)  172% $(4,437,177) $(4,143,025) $(294,152)  7%

 

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Revenue

 

For the six months ended June 30, 2018,2019, revenue from product sales was $413,818$503,508 compared to $115,912$413,818 for the six months ended June 30, 2017,2018, resulting in an increase of $297,906$86,690 or 257%22%. The increase reflects both an increased customer base for Lumega-Z as the Company expands into new clinics and increased sales of VectorVision products. $152,132, or 37% ofThe Company also earned $6,300 in revenue in 2018 was generated by sales of Lumega-Z products, representing a 31% increase in Lumega-Z sales overfrom its TDSI business during the prior period. As ofthree months ended June 30, 2018, the Company had a sales backlog of approximately $89,000 in VectorVision products, all of which were delivered and recognized as revenue in July.2019.

 

25

The following table presents the Company’s revenues disaggregated by product type:

  

Six Months Ended

June 30,

 
  2018  2017 
Lumega-Z and supplements $152,132  $115,912 
VectorVision medical devices and supplies  261,686   - 
  $413,818  $115,912 

Cost of Goods Sold

 

For the six months ended June 30, 2018,2019, cost of goods sold was $167,055$190,548 compared to $52,326$167,055 for the six months ended June 30, 2017,2018, resulting in an increase of $114,729$23,493 or 219%14%. The increase reflectsresults primarily from costs associated with the additional sales recorded in 2019 as compared to 2018.

 

Gross Profit

 

For the six months ended June 30, 2018,2019, gross profit was $246,763$312,960 compared to $63,586$246,763 for the six months ended June 30, 2017,2018, resulting in an increase of $183,177$66,197 or 288%27%. Gross profit represented 62% of revenues for the six months ended June 30, 2019, versus 60% of revenue for the six months ended June 30, 2018. The increase isin gross profit in 2019 was due primarily due to the sales of VectorVision products, which did not occurpricing and product mix changes in the prior period.2019.

 

Research and Development

 

For the six months ended June 30, 2018,2019, research and development costs were $194,708$106,716 compared to $25,770$194,708 for the six months ended June 30, 2017,2018, resulting in an increasea decrease of $168,938$87,992 or 656%45%. The increasedecrease was due to researchreduced engineering development costs associated with the Company’s MapcatSF® medical device.device during 2019 partially offset by engineering costs associated with the Company’s CSV-2000 product.

 

Sales and Marketing

 

For the six months ended June 30, 2018,2019, sales and marketing expenses were $984,464$764,028 compared to $178,333$984,464 for the six months ended June 30, 2017.2018. The increasedecrease in sales and marketing expenses of $806,131$220,436 or 452%22% compared to the prior period was primarily due to costs associated with engagement of a third party nationalthird-party contract sales team, an increased presence at trade shows, and increased consulting, marketing and promotional costs.organization in 2018. The contract sales agreement was cancelled during the second quarter of 2018.

 

General and Administrative

 

For the six months ended June 30, 2018,2019, general and administrative expenses were $2,714,680$3,439,633 compared to $1,365,807$2,714,680 for the six months ended June 30, 2017.2018. The increase of $1,348,873$724,953 or 99%27% compared to the prior period was primarily due to a $562,000an increase in non-cash stock compensation expense. Labor,costs during the current period of approximately $254,000. Additionally, expenses for corporate insurance, investor relations, labor, legal and consulting costs alsoprofessional fees, and travel have increased duringversus the prior period.

 

30

Interest Expense

 

For the six months ended June 30, 2018,2019, interest expense was $1,545$251,637 compared to $18,355$1,545 for the six months ended June 30, 2017.2018. The decreaseincrease of $16,810, or 92%,$250,092 compared to the prior period was due primarily to the repayment or conversionamortization of all promissorythe valuation of the March 2019 convertible notes and convertible debtof $250,000 that had been outstanding during 2017.was reflected as an expense when the notes were converted. There were no such costs for the comparable period in 2018.

 

Finance Cost Upon Issuance of Warrants

Finance costs for the six months ended June 30, 2019 of $415,955 include the following; (I) In March 2019, the Company issued warrants to two convertible note holders pursuant to the anticipated completion of the Company’s IPO (the IPO was completed on April 9, 2019). Due to the variable terms of both the exercise price and the number of warrants to be issued, the warrants were accounted for as derivative liabilities at March 31, 2019.  The fair value of the warrants at the closing of the IPO was determined to be $436,034, of which $250,000 was recorded as a valuation discount, and $186,034 was recorded as a finance cost. (II) On April 4, 2019, the Company issued 62,500 warrants with an exercise price of $5.00 per share to the Underwriter in connection with the Company’s IPO. The Company accounted for these warrants as a derivative liability in the financial statements at June 30, 2019 because they were associated with the IPO, a registered offering, and the settlement provisions contained language that the shares underlying the warrants are required to be registered. The fair value of the warrants at the date of issuance was determined to be $229,291 and was recorded as a finance cost.There were no such costs for the comparable period in 2018.

Change in Fair Value of Derivative Warrants

The change in fair value of the derivative warrant liability was a decrease of $227,832 for the six months ended June 30, 2019.There were no such costs for the comparable period in 2018.In March 2019, the Company issued warrants to two convertible note holders pursuant to the anticipated completion of the Company’s IPO (the IPO was completed on April 9, 2019). Due to the variable terms of both the exercise price and the number of warrants to be issued, the warrants were accounted for as derivative liabilities at March 31, 2019 with a fair value of $436,034. Upon completion of the IPO on April 9, 2019, the exercise price and the number of warrants were fixed and the warrants no longer accounted for as liabilities. As such the fair value of the warrant liability of $359,683 was reclassified to equity and the remaining liability of $76,351 was recorded as a change in fair value of derivative liabilities in the Statements of Operations.

On April 4, 2019, the Company issued 62,500 warrants with an exercise price of $5.00 per share to the Underwriter in connection with the Company’s IPO. The Company accounted for these warrants as a derivative liability in the financial statements at June 30, 2019 because they were associated with the IPO, a registered offering, and the settlement provisions contained language that the shares underlying the warrants are required to be registered. The fair value of the warrants will be remeasured at each reporting period, with the change in the fair value recognized in earnings in the accompanying Statements of Operations. The fair value of the warrants at the date of issuance was determined to be $229,291 and was recorded as a finance cost. As of June 30, 2019, the fair value of the warrant liability was determined to be $78,440 and the Company recorded a change in fair value of derivative warrants of $151,481 in the Statements of Operations.

Costs associated with extension of warrant expiration dates

 

During April and May of 2018, the Company offered exercise period extensions to stockholders who held warrants to purchase shares of common stock of the Company that were scheduled to expire on May 1, 2018. The Company recognized expense of $494,391 relating to the extension of the exercise period of the warrants using a Black-Scholes option-pricing model to estimate fair value.

 

26

Net Loss

 

For the six months ended June 30, 2018,2019, the Company incurred a net loss of $4,143,025,$4,437,177, compared to a net loss of $1,524,679$4,143,025 for the six months ended June 30, 2017.2018. The increase in net loss of $2,618,346$294,152 or 172%7% compared to the prior year period was primarily due to thean increase in non-cash expenses related to stock compensation costs of approximately $254,000. In addition, expenses for corporate insurance, investor relations, labor, legal and professional fees, and travel have increased versus the prior period but were offset by the elimination of costs associated with engagement of a third-party contract sales organization in 2018.

31

Segment Information

The following tables set forth our results of operations by segment (results allocated to Other consist of non-cash stock compensation expense, depreciation and amortization, corporate legal fees, and the extensionTDSI operations):

  For the Six Months Ended June 30, 2019 
  Other  Medical Foods  Vision Testing
Diagnostics
  Total 
             
Revenue $6,300  $204,382  $292,826  $503,508 
                 
Cost of goods sold  2,559   78,953   109,036   190,548 
                 
Gross profit  3,741   125,429   183,790   312,960 
                 
Operating expenses  1,959,838   2,003,320   347,219   4,310,377 
                 
Loss from operations $(1,956,097) $(1,877,891) $(163,429) $(3,997,417)

  For the Six Months Ended June 30, 2018 
  Other  Medical Foods  Vision Testing
Diagnostics
  Total 
             
Revenue $-  $154,294  $259,524  $413,818 
                 
Cost of goods sold  -   72,238   94,817   167,055 
                 
Gross profit  -   82,056   164,707   246,763 
                 
Operating expenses  1,523,133   2,206,967   163,752   3,893,852 
                 
Loss from operations $(1,523,133) $(2,124,911) $955  $(3,647,089)

For the six months ended June 30, 2019, revenue from our Medical Foods segment was $204,382 compared to $154,294 for the six months ended June 30, 2018, resulting in an increase of warrant expiration dates,$50,088 or 32%. The increase reflects an increased customer base for Lumega-Z as wellthe Company expands into new clinics. For the six months ended June 30, 2019, revenue from our Vision Testing Diagnostics segment was $292,826 compared to $259,524 for the six months ended June 30, 2018, resulting in an increase of $33,302 or 13%. The increase was due to increased distributor sales in 2019. The Company also earned $6,300 in diagnostic imaging services revenue from its TDSI business during the three months ended June 30, 2019, as shown in the Other category above.

Cost of Goods Sold

For the six months ended June 30, 2019, cost of goods sold from our Medical Foods segment was $78,953 compared to $72,238 for the increasedsix months ended June 30, 2018, resulting in an increase of $6,715 or 9%. For the six months ended June 30, 2019, cost of goods sold from our Vision Testing Diagnostics segment was $109,036 compared to $94,817 for the six months ended June 30, 2018, resulting in an increase of $14,219 or 15%. The increase for both segments results primarily from costs associated with the additional sales team, legal expenses, and its internal labor force.recorded in 2019 as compared to 2018.

32

Gross Profit

 

For the six months ended June 30, 2019, gross profit from the Medical Foods segment was $125,429 compared to $82,056 for the six months ended June 30, 2018, resulting in an increase of $43,373 or 53%. For the six months ended June 30, 2019, gross profit from the Vision Testing Diagnostics segment was $183,790 compared to $164,707 for the six months ended June 30, 2018, resulting in an increase of $19,083 or 12%. The increase is due to the additional sales recorded for both segments in the current year. Gross profit overall represented 62% of revenues for the six months ended June 30, 2019, versus 60% of revenue for the six months ended June 30, 2018. The increase in 2019 was due increased sales and to pricing and product mix changes in 2019.

Liquidity and Capital Resources

 

Since its formation in 2009, the Company has devoted substantial effort and capital resources to the development and commercialization activities related to its lead product Lumega-Z and its MapcatSF medical device. As a result of these and other activities, the Company utilized cash in operating activities of $2,424,058$2,493,696 during the six months ended June 30, 2018.2019. The Company had positive working capital of $1,947,866$2,326,641 at June 30, 2018 due primarily to its sale of its common stock in November 2017.2019. As of June 30, 2018,2019, the Company had cash in the amount of $2,066,365$2,368,645 and no available borrowings. The Company’s financing has historically come primarily from the issuance of convertible notes, promissory notes and from the sale of common and preferred stock and exercise of warrants.stocks.

 

The financial statements have been prepared assuming the Company will continue as a going concern. The Company had a net loss of $4,143,025 and utilized cash in operating activities of $2,424,058 during the six months ended June 30, 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 independent registered public accounting firm has also included explanatory language in their opinion accompanying the Company’s audited financial statements for the year ended December 31, 2017.2018. 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 Lumega-Z, the MapcatSF® medical device, VectorVision products, the TDSI business and VectorVision products.with respect to efforts to continue to build the Company’s infrastructure. 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 or product lines. On April 9, 2019, the Company completed the IPO, resulting in net cash proceeds of $3,888,000 to the Company. The Company is continuing attemptsseeking 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.

 

Sources and Uses of Cash

 

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

 

 

Six Months Ended

June 30,

  

Six Months Ended

June 30,

 
 2018  2017  2019  2018 
Net cash used in operating activities $(2,424,058) $(1,023,321) $(2,493,696) $(2,424,058)
Net cash used in investing activities  (187,073)  (5,500)  (58,934)  (187,073)
Net cash (used in) provided by financing activities  (57,734)  1,263,837 
Net (decrease) increase in cash $(2,668,865) $235,016 
Net cash provided by (used in) financing activities  4,250,327   (57,734)
Net increase (decrease) in cash $1,697,697  $(2,668,865)

Operating Activities

 

Net cash used in operating activities was $2,424,058$2,493,696 during the six months ended June 30, 2018,2019, versus $1,023,321$2,424,058 used during the comparable prior year period. The increaseCash in 2018both periods was due primarily to higher sales, marketing,used for used for engineering, corporate insurance, investor relations, labor, legal and legalprofessional fees, travel and other operating costs.

 

 2733 

 

Investing Activities

 

Net cash used in investing activities was $58,934 for the six months ended June 30, 2019 and $187,073 for the six months ended June 30, 2018 and $5,5002018. In June 2019, we purchased medical imaging equipment for the six months ended June 30, 2017.use in our TDSI business. In January 2018, we acquired the rights to a trademark portfolio for $50,000. In addition, we invested inpurchased a trade show booth in February.February 2018 and have invested in MapCatSF equipment and internal-use software development.

 

Financing Activities

 

Net cash provided by financing activities was $4,250,327 for the six months ended June 30, 2019 was due primarily to the completion of our IPO, which resulted in net proceeds of $3,888,000. In addition, in March 2019, the Company issued $350,000 in promissory and convertible promissory notes and received cash of $131,875 from the exercise of warrants. These proceeds were partially offset by payment of $100,000 to settle a promissory note. Net cash used in financing activities was $57,734 for the six months ended June 30, 2018 was due primarily to the Companyour payoff of a line of credit balance that had been assumed during our 2017 VectorVision acquisition.

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

  Years Ended
December 31,
 
  2018  2017 
Net cash used in operating activities $(4,173,831) $(3,403,696)
Net cash used in investing activities  (310,243)  (32,385)
Net cash provided by financing activities  419,792   8,108,791 
Net (decrease) increase in cash $(4,064,282) $4,672,710 

Operating Activities

Net cash used in operating activities was $4,173,831 during the year ended December 31, 2018, versus $3,403,696 used during the comparable prior year period. The increase in 2018 was due primarily to higher sales, marketing, professional services, and labor costs.

Investing Activities

Net cash used in investing activities was $310,243 for the year ended December 31, 2018 and $32,385 for the year ended December 31, 2017. In January 2018, we acquired the rights to a trademark portfolio for $50,000. In addition, we purchased a trade show booth in February 2018 and have invested in MapCat equipment and internal-use software development.

Financing Activities

Net cash provided by financing activities was $419,792 for the year ended December 31, 2018 was due to the sale in November and December of $850,000 in common stock and the exercise of warrants for proceeds of $16,460. These proceeds were partially offset by the payoff of a $30,535 line of credit balance that had been assumed from the VectorVision transaction. Financingtransaction as well as payment of $146,133 due to related parties. Net cash provided by financing activities was $8,108,791 for the prior year comparable period providedended December 31, 2017, consisting of $5,000,001 in proceeds from the issuance of common stock, $3,105,000 in proceeds from the issuance of preferred stock, and proceeds of $100,000 from the issuance of short-term loans, offset bya note payable. Partially offsetting proceeds received were $150,860 of payments on notes payable and $54,650 of principal and interest on loans of $14,000, $1,100,000 in proceeds from the issuance of Series B Preferred Stock, and $77,837 in amountspayments due to related parties on a net basis.parties.

 

Off-Balance Sheet Arrangements

 

At June 30, 20182019 and December 31, 2017, we2018, the Company 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.

Changes in Internal Control Over Financial Reporting

There have been no changes in the Company’s internal control over financial reporting identified in connection with the evaluation that occurred during the firstsecond quarter ended in 20182019 that have materially affected, or are reasonably likely to materially affect, the internal control over financial reporting.

 

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PART II – OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

The Company is not currently a party to any material legal proceedings and is not aware of any pending or threatened legal proceeding against the Company that the Company believes could have a material adverse effect on its business, operating results, cash flows or financial condition. 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. Regardless of the outcome, such proceedings or claims can have an adverse impact on the Company because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained. In the opinion of management of the Company, adequate provision has been made in the Company’s condensed consolidated financial statements at June 30, 20182019 with respect to such matters, including the matter noted below.matters.

On or about July 26, 2017, the Company received a payment demand from a former consultant to the Company alleging that the consultant is owed approximately $192,000 for services rendered. The Company has disputed this demand and attempts to resolve this matter were unsuccessful. On January 29, 2018, the Company filed a lawsuit against the 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, seeking payment for services rendered and seeking declaratory relief regarding ownership interest in the Company. The Company intends to vigorously defend its rights. The Company cannot predict the outcome of this matter.

 

ITEM 1A. RISK FACTORS

 

NotThe Company is not required for smallerto provide the information required by this Item as it is a “smaller reporting companies.company,” as defined in Rule 229.10(f)(1).

 

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

 

In January 2018,The following securities were sold pursuant to the exemption afforded under Sections 4(a)(2) and 3(a)(9) of the Securities Act of 1933. There were no placement agents or underwriters for any of the following private placements.

On April 9, 2019, the Company granted our CEO, Michael Favish, 1,250,000 common stock shares issuable upon the exercise of a common stock purchase option with a per share exercise price of $4.40 per share and a five-year term. The option vests ratably on the last day of each calendar quarter following the date of grant over a period of three (3) years and is subject to Mr. Favish remaining employed with the Company on the applicable vesting dates.

On April 9, 2019, the Company issued 109,038 shares of common stock upon the conversion of promissory notes of $250,000 that were mandatorily convertible upon the completion of the IPO.

On April 12, 2019, an investor exercised warrants for 146,00026,250 shares of common stock. The warrants were exercisable for $0.01$0.50 per share, and the Company received $1,460$13,125 in cash. The Company issued the shares and recorded the cash received as additional equity.

 

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 granted a stock option to the consultant to purchaseApril 5 and 17, 2019, investors exercised a total of 500,000275,000 warrants on a cashless basis resulting in the issuance of 229,365 shares of common stock. The warrants were exercisable for $0.50 and $2.00 per share.

As compensation for services rendered, the Company issued a total of 54,390 shares of common stock of the Company. 250,000in April, May, and June 2019.

On May 6, 2019, an investor exercised warrants for 125,000 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. As of June 30, 2018, the 250,000 options that remain to vestcommon stock. The warrants were valued in total at $287,365 based upon a Black-Scholes option-pricing model. Compensation cost is measured as the fair value at the end of each reporting period and cost is amortized based upon a graded vesting schedule. The options are non-qualified, have an exercise price of $1.25exercisable for $0.50 per share, and will expire 5 years from the grant date. During the six months ended June 30, 2018, the Company recognized stock compensation costs of $384,046 related to these options.received $62,500 in cash.

 

On July 25, 2018, the Company entered into a product development consulting agreement with a product development company to design and create a working prototype device based on certain intellectual property owned by the Company. In conjunction with the product development agreement, the Company granted a stock option to the consultant to purchaseMay 20, 2019, an investor exercised a total of 100,00050,000 warrants on a cashless basis resulting in the issuance of 33,108 shares of the common stock of the Company. 25,000stock. The warrants were exercisable for $0.50 per share.

On May 21, 2019, an investor exercised warrants for 50,000 shares of the option vested immediately, 50,000 shares vest upon completion of designcommon stock. The warrants were exercisable for $0.50 per share, and construction of the AcQviz device to the reasonable satisfaction of the Company and the remaining 25,000 shares vest upon integration of the AcQviz send/receive functionality with vision testing software platform to the reasonable satisfaction of the Company.received $25,000 in cash.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

Not applicable.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

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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.

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 10th12th day of August, 2018.2019.

 

Signature Title Date
     
/s/ Michael Favish CEO, President and August 10, 201812, 2019
Michael Favish 

Chairman of the Board

(Principal Executive Officer)

  
     
/s/ John TownsendController and Chief Accounting Officer August 10, 201812, 2019
John Townsend (Principal Accounting Officer)  

 

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INDEX TO EXHIBITS

 

Exhibit No. Description
3.1Certificate of Elimination of Designations, Preferences and Rights of Series A and Series B Convertible Preferred Stock (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)
31.1 Certification 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
32.1* 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 period ended June 30, 2018,2019, 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

 

*A 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 by 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.

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