UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

 

 

FORM 10-Q

 

 

 

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

 

For the quarterly period ended September 30, 2018.2019.

 

OR

 

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

 

For the transition period from________ to_________.to _________.

 

Commission File Number: 001-38298

 

 

 

Zomedica Pharmaceuticals Corp.

(Exact name of registrant as specified in its charter)

 

 

 

Alberta, Canada N/A
(State or other jurisdiction of
incorporation or organization)
 

(I.R.S. Employer

Identification Number)

 

100 Phoenix Drive, Suite 190

Ann Arbor, Michigan

 48108
(Address of principal executive offices) (Zip code)

 

(734) 369-2555

(Registrant’s telephone number, including area code)

 

 

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X ][X] No [  ]

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files). Yes [X] 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 company

[X]

   Emerging growth company[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. [X]

 

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

 

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

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Shares, without par valueZOMNYSE American

As of November 13, 2018, 94,796,20912, 2019, 108,038,398 shares of the registrant’s common shares, without par value, were issued and outstanding.

 

Zomedica Pharmaceuticals Corporation

FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED

SEPTEMBER 30, 20182019

 

TABLE OF CONTENTS

 

 Page
PART I 
  
FINANCIAL INFORMATION 
  
1. Condensed Financial Statements31
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations2022
3. Quantitative and Qualitative Disclosures about Market Risk3033
4. Controls and Procedures3033
  
PART II 
  
OTHER INFORMATION 
  
1. Legal Proceedings
1A. Risk Factors3134
1A. Risk Factors6. Exhibits31
2. Unregistered Sales of Equity Securities and Use of Proceeds36
3. Defaults Upon Senior Securities36
4. Mine Safety Disclosures36
5. Other Information36
6. Exhibits3639

 

2

 

PART I — FINANCIAL INFORMATION

 

Item 1. Financial Statements.

 

Zomedica Pharmaceuticals Corp.

Condensed unaudited interim consolidated financial statements

For the three and nine months ended September 30, 2019 and 2018

(Expressed in United States Dollars, except as otherwise noted)

Zomedica Pharmaceuticals Corp.

Condensed unaudited interim consolidated balance sheets

As at September 30, 20182019 and December 31, 20172018

(Stated in United States dollars)

 

   September 30, December 31,     September 30, December 31, 
 Note  2018  2017  Note  2019  2018 
                  
Assets                      
                      
Current assets:                      
Cash and cash equivalents     $526,817  $3,448,147     $2,487,651  $1,940,265 
Prepaid expenses and deposits  5   1,481,673   786,273  5   1,497,425   1,867,034 
Trade and other receivables     37,742   28,272 
Trade and other receivable     75,992   53,659 
     2,046,232   4,262,692      4,061,068   3,860,958 
                      
Prepaid expenses and deposits  5   1,374,260   566,832  5   -   1,442,415 
Property and equipment  6   756,823   371,157  6   805,218   717,088 
Right-of-use asset 8   1,231,003   - 
Intangible assets  7   13,331   15,141  7   513,735   13,058 
    $4,190,646  $5,215,822     $6,611,024  $6,033,519 
                      
                      
Liabilities and shareholders' equity                      
                      
Current liabilities:                      
Accounts payable and accrued liabilities    $1,280,379  $828,737     $1,577,525  $2,376,519 
     1,280,379   828,737      1,577,525   2,376,519 
                      
Shareholders' equity:                      
Capital stock                      
Authorized           
Unlimited common shares without par value           
Issued and outstanding           
94,596,209 common shares (2017 - 90,225,869)  9   25,373,456   18,244,659 
Series 1 preferred shares, without par value; 20 shares authorized (2018 - nil)
Issued and outstanding 12 series 1 preferred shares (2018 - nil)
 10   11,961,397   - 
Unlimited common shares without par value; Issued and outstanding 108,038,398 common shares (2018 - 97,598,898) 11   38,647,822   30,410,648 
Common stock subscribed     -   4,280,000 
Additional paid-in capital  10   1,388,916   1,768,526  12   3,625,083   1,240,139 
Accumulated deficit     (23,852,105)  (15,626,100)     (49,200,803)  (32,273,787)
     2,910,267   4,387,085      5,033,499   3,657,000 
                      
    $4,190,646  $5,215,822     $6,611,024  $6,033,519 

Nature of operations and going concern (Note 1)

Commitments and contingencies (Note 13)

 

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

3

 


Zomedica Pharmaceuticals Corp.

Condensed unaudited interim consolidated statements of operations and comprehensive loss

For the three and nine months ended September 30, 20182019 and 20172018

(Stated in United States dollars)

 

    Three months ended September 30, Nine months ended September 30,   

Three months ended September 30,

 

Nine months ended September 30,

 
 Note  2018  2017  2018  2017  Note2019  2018  2019  2018 
                        
Expenses:                                    
Research and development  14  $630,371  $465,495  $3,765,332  $1,586,179  16$962,463  $630,371  $9,555,345  $3,765,332 
General and administrative  14   834,570   1,350,726   3,243,232   2,926,361  16 1,404,952   834,570   5,557,661   3,243,232 
Professional fees  14   293,484   246,192   1,001,886   942,385  16 279,237   293,484   1,230,151   1,001,886 
Amortization  7   431   699   1,810   2,098 
Amortization - right-of-use asset 8 127,345   -   382,035   - 
Amortization - intangible asset 7 273   431   810   1,810 
Depreciation  6   86,162   22,903   150,320   65,994  6 70,096   86,162   201,075   150,320 
Loss from operations     1,845,018   2,086,015   8,162,580   5,523,017    2,844,366   1,845,018   16,927,077   8,162,580 
Loss on fixed assets   -   69,382   1,308   69,382 
Interest expense   -   -   18,338   - 
Gain on settlement of liabilities     -   -   -   (5,000) 11 -   -   (19,737)  - 
Loss on sale of equipment     69,382   -   69,382   - 
Foreign exchange gain     (4,122)  (5,333)  (5,957)  (16,229)   1,313   (4,122)  30   (5,957)
Loss before income taxes     1,910,278   2,080,682   8,226,005   5,501,788    2,845,679   1,910,278   16,927,016   8,226,005 
Income tax expense     -   -   -   -    -   -   -   - 
Net loss and comprehensive loss    $1,910,278  $2,080,682  $8,226,005  $5,501,788   $2,845,679  $1,910,278  $16,927,016  $8,226,005 
                                    
Weighted average number of common shares - basic and diluted     94,514,905   88,844,534   92,534,667   86,708,499    108,038,398   94,514,905   105,711,459   92,534,667 
                                    
Loss per share - basic and diluted    $(0.02) $(0.02) $(0.09) $(0.06)  $(0.03) $(0.02) $(0.16) $(0.09)

Nature of operations and going concern (Note 1)

Commitments and contingencies (Note 11)

 

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

 

4

 


Zomedica Pharmaceuticals Corp.

Condensed unaudited interim consolidated statements of shareholders’ equity

For the three and nine months ended September 30, 20182019 and 20172018

(Stated in United States dollars)

 

 Note Number  Capital stock  Additional paid-in capital  Accumulated deficit  Total   Series 1 preferred stock Common stock            
                 NoteShares  Amount  Shares  Amount  Common stock subscribed  Additional paid-in capital  Accumulated deficit  Total 
Balance at December 31, 2016    83,964,569  $10,189,973  $1,205,456  $(7,561,028) $3,834,401 
Stock issuance for services 9  43,613   45,000   -   -   45,000 
Stock issuance for financing, net of cost 9  4,405,373   6,516,650   -   -   6,516,650 
Stock-based compensation 10  -   -   837,531   -   837,531 
Stock issued due to exercise of options 9  925,000   130,354   (30,156)  -   100,198 
Net loss for the period    -   -   -   (5,501,788)  (5,501,788)
Balance at September 30, 2017    89,338,555  $16,881,977  $2,012,831  $(13,062,816) $5,831,992 
                                            
Balance at December 31, 2017    90,225,869  $18,244,659  $1,768,526  $(15,626,100) $4,387,085    -  $-   90,225,869  $18,244,659  $-  $1,768,526  $(15,626,100) $4,387,085 
Stock issuance for services 9  641,717   1,238,513   -   -   1,238,513    -   -   641,717   1,238,513   -   -   -   1,238,513 
Stock issuance for financing, net of cost 9  1,861,627   3,966,362   -   -   3,966,362    -   -   1,861,627   3,966,362   -   -   -   3,966,362 
Stock-based compensation    -   -   7,288   -   7,288  12 -   -   -   -   -   7,288   -   7,288 
Stock issued due to exercise of options 10  1,866,996   1,923,922   (386,898)  -   1,537,024 
Net loss for the period    -   -   -   (8,226,005)  (8,226,005)
Stock issuance due to exercise of options 11,12 -   -   1,866,996   1,923,922   -   (386,898)  -   1,537,024 
Net loss   -   -   -   -   -   -   (8,226,005)  (8,226,005)
Balance at September 30, 2018    94,596,209  $25,373,456  $1,388,916  $(23,852,105) $2,910,267    -  $-   94,596,209  $25,373,456  $-  $1,388,916  $(23,852,105) $2,910,267 
                                 
Balance at December 31, 2018   -  $-   97,598,898  $30,410,648  $4,280,000  $1,240,139  $(32,273,787) $3,657,000 
Stock issuance for services 11 -   -   707,236   792,104   -   -   -   792,104 
Stock issuance for financing, net of cost 10,11 12   11,961,397   9,337,529   6,690,922   (4,280,000)  -   -   14,372,319 
Stock-based compensation 12 -   -   -   -   -   2,539,092   -   2,539,092 
Stock issuance due to exercise of options 11,12 -   -   394,735   754,148   -   (154,148)  -   600,000 
Net loss   -   -   -   -   -   -   (16,927,016)  (16,927,016)
Balance at September 30, 2019   12  $11,961,397   108,038,398  $38,647,822  $-  $3,625,083  $(49,200,803) $5,033,499 

 

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

 

5

 


Zomedica Pharmaceuticals Corp.

Condensed unaudited interim consolidated statements of cash flows

For the three and nine months ended September 30, 20182019 and 20172018

(Stated in United States dollars)

 

   Three months ended September 30, Nine months ended September 30,  

Three months ended September 30,

 

Nine months ended September 30,

 
 Note  2018  2017  2018  2017 Note2019  2018  2019  2018 
                     
Cash flows used in operating activities:                                   
Net loss for the period     $(1,910,278) $(2,080,682) $(8,226,005) $(5,501,788) $(2,845,679) $(1,910,278) $(16,927,016) $(8,226,005)
Adjustments for                                   
Depreciation  6   86,162   22,903   150,320   65,994 6 70,096   86,162   201,075   150,320 
Amortization  7   431   699   1,810   2,098 
Loss on sale of equipment     69,382   -   69,382   - 
Amortization - intangible assets7 273   431   810   1,810 
Amortization - right-of-use-asset8 127,345   -   382,035   - 
Loss on fixed assets6 -   69,382   1,308   69,382 
Stock issued for services  9   -   -   1,238,513   45,000 11 -   -   792,104   1,238,513 
Stock-based compensation     -   675,940   7,288   837,531 12 197,988   -   2,539,092   7,288 
Change in non-cash operating working capital                                   
Trade and other receivable     11,885   (13,340)  (9,470)  (10,231)  19,558   11,885   (22,333)  (9,470)
Prepaid expenses     56,399   45,160   (191,365)  (15,239)  (122,315)  56,399   140,695   (191,365)
Deposits     (1,281,617)  34,228   (1,311,463)  (181,193)  21,366   (1,281,617)  (76,709)  (1,311,463)
Accounts payable and accrued liabilities     (403,423)  (128,106)  451,643   (351,134)  (1,378,710)  (403,423)  (798,994)  451,643 
     (3,371,059)  (1,443,198)  (7,819,347)  (5,108,962)  (3,910,078)  (3,371,059)  (13,767,933)  (7,819,347)
                                   
Cash flows from financing activities:                   
Cash proceeds from financing  9   -   3,320,000   4,002,496   6,570,000 
Cash flows (used) from financing activities:                
Cash proceeds from financing of preferred shares10 -   -   12,000,000   - 
Cash proceeds from financing of common shares11 -   -   3,000,000   4,002,496 
Cash received from stock option exercises  10   98,716   60,655   1,537,024   100,198 12 -   98,716   600,000   1,537,024 
Cash paid on stock issuance costs     (12,328)  (19,226)  (36,135)  (53,350)10,11 (1,414)  (12,328)  (627,681)  (36,135)
Repayments of shareholder loan     -   -   -   (6,726)
     86,388   3,361,429   5,503,385   6,610,122   (1,414)  86,388   14,972,319   5,503,385 
                                   
Cash flows used in investing activities:                                   
Investment in intangibles6 (501, 487)  -   (501, 487)  - 
Investment in property and equipment  6   (467,675)  (4,775)  (605,368)  (164,576)6 (80,950)  (467,675)  (155,513)  (605,368)
     (467,675)  (4,775)  (605,368)  (164,576)  (582,437)  (467,675)  (657,000)  (605,368)
                                   
Increase (decrease) in cash and cash equivalents     (3,752,346)  1,913,456   (2,921,330)  1,336,584   (4,493,929)  (3,752,346)  547,386   (2,921,330)
                                   
Cash and cash equivalents, beginning of period     4,279,163   2,649,808   3,448,147   3,226,680   6,981,580   4,279,163   1,940,265   3,448,147 
                                   
Cash and cash equivalents, end of period    $526,817  $4,563,264  $526,817  $4,563,264  $2,487,651  $526,817  $2,487,651  $526,817 
                
Supplemental cash flow information:                
                
Interest paid $12,164  $-  $18,338  $- 

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

5

Zomedica Pharmaceuticals Corp.
Notes to the condensed unaudited interim consolidated financial statements
For the three and nine months ended September 30, 2019 and 2018
(Stated in United States dollars)

 

6

1.Nature of operations and going concern

 

Zomedica Pharmaceuticals Corp. (the("Zomedica" or the “Company”) was incorporated on January 7, 2013 under the Alberta Business Corporations Act (Alberta) as Wise Oakwood Ventures Inc. (“WOW”) and was classified as a capital pool company, as defined in Policy 2.4 of the TSX Venture Exchange. ZoMedica Pharmaceuticals Inc. was incorporated on May 14, 2015 under the Canada Business Corporations Act.

 

On April 21, 2016, the Company closed its qualifying transaction (“Transaction”) with, consisting of the acquisition of ZoMedica Pharmaceuticals Inc. (“ZoMedica”), and filed Articles of Amalgamation and pursuant to a three-cornered amalgamation, whereby ZoMedica was amalgamated with 9674128 Canada Inc. which(which was wholly-owned by WOW.WOW) and common shares and options of the Company were issued to former holders of ZoMedica securities as consideration. The amalgamated company changed its name to Zomedica Pharmaceuticals Ltd. and WOW subsequently changed its name to Zomedica Pharmaceuticals Corp. Prior to completion of the Transaction, WOW consolidated its common shares on the basis of the one post-consolidation common share for every 2.5 pre-consolidation common shares. The Transaction constituted WOW’s qualifying transaction under TSX Venture Exchange Policy 2.4 – Capital Pool Companies. The shares of Zomedica Pharmaceuticals Corp. began trading on the TSX Venture Exchange under the new symbol “ZOM” on Monday, May 2, 2016 on the TSX Venture Exchange.2016. On June 21, 2016, the Company filed Articles of Amalgamation and vertically amalgamated with its wholly-owned subsidiary, Zomedica Pharmaceuticals Ltd.

 

Zomedica has one corporate subsidiary, Zomedica Pharmaceuticals, Inc., a Delaware company whose results and operations are included in these condensed unaudited interim consolidated financial statements. The Company is a biopharmaceutical company targeting health and wellness solutions for the companion pet through a ground-breaking approach that focuses on the needs of the veterinarians themselves. Zomedica's head office is located at 100 Phoenix Drive, Suite 190, Ann Arbor, MI 48108 and its registered office is located at Suite 1250, 639 – 5th Avenue S.W., Calgary, Alberta T2P 0M9.

 

On November 20, 2017, Zomedica announced that its registration statement on Form S-1 was declared effective by the U.S. Securities and Exchange Commission and on November 21, 2017, the Company’s common shares began trading on the NYSE American under the symbol “ZOM”.

Going concern

 

These condensed unaudited interimThe consolidated financial statements have beenare prepared on a going concern basis, which contemplatesassumes that the Company will be able to realizemeet its assetsobligations and dischargecontinue its liabilities inoperations for the normal coursenext twelve months. The Company has incurred losses from operations since inception and has an accumulated deficit of business. Accordingly, they do not give effect to adjustments$49,200,803 as at September 30, 2019 (December 31, 2018 - $32,273,787). The Company has funded its research and development (“R&D”) activities principally through the issuance of securities and loans from related parties. There is no certainty that wouldsuch funding will be necessary should the Company be unableavailable going forward. These conditions raise substantial doubt about its ability to continue as a going concern and therefore be required to realize its assets and liquidatepay its liabilities as they become due.

In order for the Company to continue as a going concern and commitmentsfund any significant expansion of its operations or R&D activities, the Company will require significant additional capital. The Company’s ultimate success will depend on whether its future product candidates receive the necessary regulatory approval and it is able to successfully market approved products. The Company cannot be certain that it will be able to receive regulatory approval for any of its future product candidates, or that it will reach the level of sales and revenues necessary to achieve and sustain profitability.

The availability of equity or debt financing will be affected by, among other things, the results of the Company’s research and development, its ability to obtain regulatory approvals, the market acceptance of its products, the state of the capital markets generally, strategic alliance agreements, and other relevant commercial considerations. In addition, if the Company raises additional funds by issuing equity securities,

6

Zomedica Pharmaceuticals Corp.
Notes to the condensed unaudited interim consolidated financial statements
For the three and nine months ended September 30, 2019 and 2018
(Stated in United States dollars)

1.Nature of operations and going concern (continued)

Going concern (continued)

its then existing security holders will likely experience dilution, and the incurring of indebtedness would result in other thanincreased debt service obligations and could require the normal courseCompany to agree to operating and financial covenants that would restrict its operations. Any failure on its part to raise additional funds on terms favorable to the Company or at all, may require the Company to significantly change or curtail its current or planned operations in order to conserve cash until such time, if ever, that sufficient proceeds from operations are generated, and could result in the Company not taking advantage of business and at amounts different from those in the accompanying condensed consolidated financial statements. Such adjustments could be material.opportunities.

2.Basis of preparation

 

The accounting policies set out below have been applied consistently in the condensed unaudited interim consolidated financial statements.

 

Basis of consolidation

 

These condensed unaudited interim consolidated financial statements include the accounts of the Company and its wholly owned operating subsidiary, Zomedica Pharmaceuticals, Inc.

 

All inter-company accounts and transactions have been eliminated on consolidation.

7

 

3.Significant accounting policies

Use of estimates

 

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

 

Areas where significant judgment is involved in making estimates are: the fair values of financial assets and liabilities; the determination of fair value of stock-based compensation; the useful lives of property and equipment; deferred income taxes and forecasting future cash flows for assessing the going concern assumption.

 

Basis of measurement

 

The condensed unaudited interim consolidated financial statements have been prepared on the historical cost basis except as otherwise noted.

 

Functional and reporting currencies

 

The Company’s and subsidiary’s functional currency, as determined by management, is US dollars, which is also the Company’s reporting currency.

 

The accounting policies set out below have been applied consistently to all periods and companies presented in the condensed unaudited interim consolidated financial statements.

7

Zomedica Pharmaceuticals Corp.
Notes to the condensed unaudited interim consolidated financial statements
For the three and nine months ended September 30, 2019 and 2018
(Stated in United States dollars)

3.Significant accounting policies (continued)

Research and development

 

Research and development costs related to continued research and development programs are expensed as incurred in accordance with ASC topic 730.

Share issue costs

Share issue costs are recorded as a reduction of the proceeds from the issuance of capital stock.

 

Translation of foreign currencies

 

In respect of other transactions denominated in currencies other than the Company and its wholly owned operating subsidiaries’ functional currencies, the monetary assets and liabilities are translated at the period end rates. Revenue and expenses are translated at rates of exchange prevailing on the transaction dates. All of the exchange gains or losses resulting from these other transactions are recognized in the condensed unaudited interim consolidated statements of operations and comprehensive loss.

 

Stock-based compensation

 

The Company measures the cost of equity-settled transactions by reference to the fair value of the equity instruments at the date at which they are granted if the fair value of the goods or services received by the Company cannot be reliably estimated.

 

8

3.Significant accounting policies (continued)

Stock-based compensation (continued)

The Company calculates stock-based compensation using the fair value method, under which the fair value of the options at the grant date is calculated using the Black-Scholes Option Pricing Model, and subsequently expensed over the vesting period of the option. The provisions of the Company's stock-based compensation plans do not require the Company to settle any options by transferring cash or other assets, and therefore the Company classifies the awards as equity. Stock-based compensation expense recognized during the period is based on the value of stock-based payment awards that are ultimately expected to vest.

 

The Company estimates forfeitures at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

 

Loss per share

Basic loss per share (“EPS”) is computed by dividing the loss attributable to common shareholders by the weighted average number of common shares outstanding. Diluted EPS reflects the potential dilution that could occur from common shares issuable through the exercise or conversion of stock options, restricted stock awards, warrants and convertible securities. In certain circumstances, the conversion of options are excluded from diluted EPS if the effect of such inclusion would be anti-dilutive.

 

The dilutive effect of stock options is determined using the treasury stock method. Stock options to purchase common shares of the Company during the period were not included in the computation of diluted EPS because the Company has incurred a loss for the three and nine months ended September 30, 20182019 as the effect would be anti-dilutive.

8

Zomedica Pharmaceuticals Corp.
Notes to the condensed unaudited interim consolidated financial statements
For the three and nine months ended September 30, 2019 and 2018
(Stated in United States dollars)

3.Significant accounting policies (continued)

 

Comprehensive loss

 

The Company follows ASC topic 220. This statement establishes standards for reporting and display of comprehensive (loss) income and its components. Comprehensive loss is net loss plus certain items that are recorded directly to shareholders' equity. The Company has no other comprehensive loss items.

 

FutureRecently adopted accounting pronouncements

 

In February 2016, the FASB issued new guidance, ASU No. 2016-02, Leases (Topic 842). The main difference between current U.S. GAAPnew standard establishes a right-of-use model (“ROU”) that requires a lessee to recognize a ROU asset and the new guidance is the recognition of lease liabilities basedliability on the present valuebalance sheet for all leases with a term longer than 12 months. Leases will be classified as finance or operating, with classification affecting the pattern and classification of remaining lease payments and corresponding lease assets for operating leases under current U.S. GAAP with limited exception.expense recognition in the income statement. Additional qualitative and quantitative disclosures are also required by the new guidance. Topic 842 is effective for annual reporting periods (including interim reporting periods) beginning after December 15, 2018. Early adoption is permitted.

A modified retrospective transition approach is required, applying the new standard to all leases existing at the date of initial application. The Company adopted the new standard with an initial application date of January 1, 2019 and used the effective date as its date of initial application. Consequently, financial information was not updated, and the disclosures required under the new standard were not provided for dates and periods before January 1, 2019.

The new standard provides a number of optional practical expedients in transition. The Company has elected the ‘package of practical expedients’, which permits the Company not to reassess under the new standard prior conclusions about lease identification, lease classification and initial direct costs. The Company has not elected the use-of-hindsight or the practical expedient pertaining to land easements; the latter not being applicable to the Company.

On August 29, 2018, the FASB issued ASU 2018-15, which amends ASC 350-40 to address a customer’s accounting for implementation costs incurred in a cloud computing arrangement (CCA) that is a service contract. ASU 2018-15 aligns the accounting for costs incurred to implement a CCA that is a service arrangement with the guidance on capitalizing costs associated with developing or obtaining internal-use software. Specifically, the ASU amends ASC 350 to include in the processits scope implementation costs of evaluating the amendmentsa CCA that is a service contract and clarifies that a customer should apply ASC 350-40 to determine if they havewhich implementation costs should be capitalized in a material impact onCCA that is considered a service contract. The amendments in this update are effective for public business entities for fiscal years beginning after December 15, 2019. Early adoption is permitted.

The Company has chosen to adopt this guidance during the Company’s financial position, results of operations, cash flows or disclosures.three months ended September 30, 2019.

 

9

9

 

Zomedica Pharmaceuticals Corp.
Notes to the condensed unaudited interim consolidated financial statements
For the three and nine months ended September 30, 2019 and 2018
(Stated in United States dollars)

 

4.Critical accounting judgments and key sources of estimation uncertainty

 

The preparation of consolidated financial statements requires management to make judgments, estimates and assumptions that affect the application of policies and reported amounts of assets and liabilities, and revenue and expenses. The estimates and associated assumptions are based on historical experience and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis of making the judgments about carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates.

The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and further periods if the review affects both current and future periods.

 

Critical areas of estimation and judgements in applying accounting policies include the following:

 

Going concern

These condensed unaudited interim consolidated financial statements have been prepared in accordance with U.S. GAAP on a going concern basis, which assumes the realization of assets and discharge of liabilities in the normal course of business within the foreseeable future. Management uses judgment in determining assumptions for cash flow projections, such as anticipated financing, anticipated sales and future commitments to assess the Company’s ability to continue as a going concern. A critical judgment is that the Company continues to raise funds going forward and satisfy their obligations as they become due.

 

Stock-based payments

The Company estimates the fair value of convertible securities such as options using the Black-Scholes option-pricing model which requires significant estimation around assumptions and inputs such as expected term to maturity, expected volatility and expected dividends.

Useful lives of property and equipment

 

As described in Note 3 above, theThe Company reviews the estimated useful lives of property and equipment with definite useful lives at the end of each year and assesses whether the useful lives of certain items should be shortened or extended, due to various factors including technology, competition and revised service offerings. During the three and nine month periodmonths ended September 30, 2018 and September 30, 2017,2019, the Company was not required to adjust the useful lives of any assets based on the factors described above. Long-lived assets are reviewed for impairment when events or circumstances indicate that the carrying value of an asset may not be recoverable.

 

Deferred income taxes

 

The calculation of deferred income taxes is based on assumptions which are subject to uncertainty as to timing and which tax rates are expected to apply when temporary differences reverse. Deferred tax recorded is also subject to uncertainty regarding the magnitude of non-capital losses available for carry forward and of the balances in various tax pools. By their nature, these estimates are subject to measurement uncertainty, and the effect on the financial statements from changes in such estimates in future period could be material. Deferred tax assets are recognized to the extent that it is probable that they will be able to be utilized against future taxable income. Deferred tax assets are reviewed at each balance sheet date and adjusted to the extent that it is no longer probable that the related tax benefit will be realized.

 

Stock-based payments

The Company estimates the fair value of convertible securities such as options using the Black-Scholes option-pricing model which requires significant estimation around assumptions and inputs such as expected term to maturity, expected volatility and expected dividends.10

Zomedica Pharmaceuticals Corp.
Notes to the condensed unaudited interim consolidated financial statements
For the three and nine months ended September 30, 2019 and 2018
(Stated in United States dollars)

 

10

5.Prepaid expenses and deposits

 

The Company entered into a lease agreement with Wickfield Phoenix LLC effective on August 23, 2016. The Company prepaid the full outstanding balance of $801,973 on August 26, 2016 and recorded the prepaid rent due within a year as current. On July 31, 2018 the Company entered into an amendment to the lease agreement for additional office space. The Company prepaid the full outstanding balance of $1,269,073 and recorded the prepaid rent due within one year as current. At September 30, 2018, the Company has classified $509,380 as a current asset in the condensed unaudited interim consolidated balance sheet (December 31, 2017 - $155,220).

  September 30,  December 31, 
  2019  2018 
Prepaid rent (i) $-  $1,613,038 
Deposits (ii)  1,202,814   1,596,104 
Prepaid FDA fees  31,497   - 
Prepaid marketing (iii)  36,596   37,465 
Prepaid insurance (iii)  156,044   33,372 
Other (iv)  70,474   29,470 
Total $1,497,425  $3,309,449 

 

(i)On July 31, 2018, the Company entered into an amended lease agreement with Wickfield Phoenix LLC for an additional 18,640 square feet of office space. The Company prepaid the full outstanding balance of $1,269,073. As of January 1, 2019, the balance of the prepaid rent, inclusive of the original and amended lease amounts was $1,613,038. In accordance with ASC 842, this amount was reclassified as a right-of-use asset in the consolidated balance sheet. As of December 31, 2018, the Company classified $509,380 as a current asset in the consolidated balance sheet;

(ii)Deposits include payments made to vendors in advance and are primarily associated with research activity, deposits for leasehold improvements, and equipment purchases. As of September 30, 2019, and December 31, 2018, the Company classified $1,202,814 and $922,347 as a current asset in the consolidated balance sheet, respectively;

(iii)As of September 30, 2019, and December 31, 2018, all amounts were classified as a current asset in the consolidated balance sheet;

(iv)Other prepaid expenses and deposits are comprised of subscription payments and software licensing. As of September 30, 2019, and December 31, 2018, the Company classified all amounts as a current asset in the consolidated balance sheet.

11

Zomedica Pharmaceuticals Corp.
Notes to the condensed unaudited interim consolidated financial statements
For the three and nine months ended September 30, 2019 and 2018
(Stated in United States dollars)

6.Property and equipment

 

 Computer equipment  Furniture and equipment  Laboratory equipment  Leasehold improvements  Total  Computer equipment  Furniture and equipment  Laboratory equipment  Leasehold improvements  Total 
Cost                                   
Balance at December 31, 2016 $61,598  $7,364  $243,529  $25,672  $338,163 
Additions  89,557   68,694   2,200   11,285   171,736 
Balance at December 31, 2017  151,155   76,058   245,729   36,957   509,899  $151,155  $76,058  $245,729  $36,957  $509,899 
Additions  11,701   105,821   246,375   250,471   614,368   18,847   105,821   246,375   256,954   627,997 
Disposals  -   -   (139,466)  (10,937)  (150,403)  -   -   (139,467)  (10,936)  (150,403)
Balance at September 30, 2018  162,856   181,879   352,638   276,491   973,864 
Balance at December 31, 2018  170,002   181,879   352,637   282,975   987,493 
Additions  218,076   3,414   3,350   65,673   290,513 
Disposals  (2,210)  -   -   -   (2,210)
Balance at September 30, 2019  385,868   185,293   355,987   348,648   1,275,796 
                                        
Accumulated depreciation                                        
Balance at December 31, 2016  13,858   1,490   29,783   3,998   49,129 
Depreciation  28,944   10,355   45,092   5,222   89,613 
Balance at December 31, 2017  42,802   11,845   74,875   9,220   138,742   42,802   11,845   74,875   9,220   138,742 
Depreciation  66,405   11,130   42,082   30,703   150,320   62,116   17,740   86,368   37,460   203,684 
Disposals  -   -   (61,546)  (10,475)  (72,021)  -   -   (61,547)  (10,474)  (72,021)
Balance at September 30, 2018  109,207   22,975   55,411   29,448   217,041 
Balance at December 31, 2018  104,918   29,585   99,696   36,206   270,405 
Depreciation  60,561   19,885   51,151   69,478   201,075 
Disposals  (902)  -   -   -   (902)
Balance at September 30, 2019  164,577   49,470   150,847   105,684   470,578 
  109,207   22,975   55,411   29,448   217,041                     
Net book value as at:                                        
December 31, 2017 $108,353  $64,213  $170,854  $27,737  $371,157 
September 30, 2018 $53,649  $158,904  $297,227  $247,043  $756,823 
December 31, 2018 $65,084  $152,294  $252,941  $246,769  $717,088 
September 30, 2019 $221,291  $135,823  $205,140  $242,964  $805,218 

 

In August of 2018,February 2019, the Company relocated partreclassified $135,000 out of its operations to a new building. Due to the relocation, leasehold improvements with a net book value of $462 were written offprepaid assets into property and equipment with a net book value of $77,920 was sold for $9,000. The net loss on disposal recorded was $69,382.equipment.

11

 

7.Intangible assets

 

 Computer software  Trademarks  Total  Computer software  Trademarks  Total intangible assets 
Cost                     
Balance at December 31, 2016 $5,143  $16,236  $21,379 
Additions  -   -   - 
Balance at December 31, 2017  5,143   16,236   21,379  $5,143  $16,236  $21,379 
Additions  -   -   -   -   -   - 
Balance at September 30, 2018  5,143   16,236   21,379 
Balance at December 31, 2018  5,143   16,236   21,379 
Additions  501,487   -   501,487 
Balance at September 30, 2019  506,630   16,236   522,866 
                        
Accumulated amortization                        
Balance at December 31, 2016  2,428   1,013   3,441 
Amortization  1,715   1,082   2,797 
Balance at December 31, 2017  4,143   2,095   6,238   4,143   2,095   6,238 
Amortization  1,000   810   1,810   1,000   1,083   2,083 
Balance at September 30, 2018  5,143   2,905   8,048 
Balance at December 31, 2018  5,143   3,178   8,321 
Amortization  -   810   810 
Balance at September 30, 2019  5,143   3,988   9,131 
                        
Net book value as at:                        
December 31, 2017 $1,000  $14,141  $15,141 
September 30, 2018 $-  $13,331  $13,331 
December 31, 2018 $-  $13,058  $13,058 
September 30, 2019 $501,487  $12,248  $513,735 

12

Zomedica Pharmaceuticals Corp.
Notes to the condensed unaudited interim consolidated financial statements
For the three and nine months ended September 30, 2019 and 2018
(Stated in United States dollars)


8.Leases

As discussed in Note 3, the Company adopted ASC 842 with an initial application date of January 1, 2019. The Company is party to two lease agreements under which it rents office and laboratory space. The rent for both of these leases was prepaid upon inception and therefore at adoption the Company reclassified its prepaid lease balances of $1,613,038 to a right-of-use asset.

The Company amortizes the asset on a straight-line basis and records the expense in the consolidated statement of operations and comprehensive loss. During the three and nine months ended September 30, 2019, the Company recognized $127,345 and $382,035 (2018 – nil) in amortization expense in the consolidated statements of operations and comprehensive loss.

 

8.9.Loan arrangements

 

On October 17, 2017, the Company entered into a loan arrangement with a shareholder of the Company, pursuant to which such shareholder has agreed to provide a loan facility to the Company, whereby the Company may borrow up to $5,000,000, with the proceeds to be used for working capital and general corporate purposes. The term of the loan facility is five (5) years, with principal and interest payments being due only at the time of maturity. Under the loan agreement, the Company may borrow in one or more advances, provided however that a minimum amount of $250,000 must be borrowed at any one time and not more than two advances may occur per month. Interest shall accrue at a rate of fourteen percent (14%) per annum, payable upon maturity. As of September 30, 2018,2019, no amounts have been borrowed.

10.Preferred stock

The Company is authorized to issue up to 20 shares of our Series 1 Preferred Shares, all without par value, and each having a stated value of $1,000,000. The Series 1 Preferred Shares do not have voting rights except to the extent required by applicable law and are not convertible into the Company’s common shares. Holders of the Series 1 Preferred Shares will not be entitled to dividends but, in lieu thereof, will receive Net Sales Payments (“Net Sales Payments” is defined as annual payments equal to 9 percent of sales) until such time as the holders have received total Net Sales Payments equal to 9 times the aggregate stated value of the outstanding Series 1 Preferred Shares. The Company will have the right to redeem the outstanding Series 1 Preferred Shares at any time at a redemption price equal to 9 times the aggregate stated value of the Series 1 Preferred Shares outstanding less the aggregate amount of the Net Sales Payments paid (the “Redemption Amount”).

Upon any dissolution, liquidation or winding up, whether voluntary or involuntary, holders of Series 1 Preferred Shares will be entitled to a liquidation preference equal to the stated value of the Series 1 Preferred Shares less the Net Sales Payments paid on the Series 1 Preferred Shares.

In the event of a fundamental transaction (defined to include an amalgamation, merger or other business combination transaction involving our company in which our shareholders do not have the right to cast more than 50% of the votes that may be cast for the election of directors, or a sale, lease or other disposition of the properties and/or assets of our company as an entirety or substantially as an entirety to a third party), the holders of the Series 1 Preferred Shares will be entitled to receive consideration for their Series 1 Preferred Shares equal to a multiple of the stated value of the Series 1 Preferred Shares ranging from 5.0 to 9.0 depending on the timing of the fundamental transaction, subject to a cap equal to the redemption amount. The Company has assessed the likelihood of any Net Sales Payments to the Series 1 Preferred shareholders to be remote.

13

Zomedica Pharmaceuticals Corp.
Notes to the condensed unaudited interim consolidated financial statements
For the three and nine months ended September 30, 2019 and 2018
(Stated in United States dollars)

10.Preferred stock (continued)

Issued and outstanding preferred stock:

 

  Number of    
  preferred  Preferred 
  stock  stock amount 
Balance at December 31, 2018  -  $- 
Stock issued from financing (i)  12   11,961,397 
Balance at September 30, 2019  12  $11,961,397 

12(i)On May 9, 2019, the Company entered into subscription agreements to sell $12,000,000 of its Series 1 Preferred Shares to an accredited investor in a private placement at a purchase price of $1,000,000 per Series 1 Preferred Share; $5,000,000 of the purchase price was paid on May 9, 2019 and the remaining $7,000,000 was paid on June 7, 2019. The Company recorded $1,414 and $38,603 of share issuance costs as an offset to preferred stock in the three and nine months ended September 30, 2019

 

9.11.CapitalCommon stock

 

The Company is authorized to issue an unlimited number of common stock,shares, all without par value.

 

Issued and outstanding common stock:

 

     Capital 
  Number  stock 
Balance at December 31, 2016  83,964,569  $10,189,973 
Stock issuance for services  43,613   45,000 
Stock issued due to exercise of options  925,000   130,354 
Stock issuance for financing, net of costs  4,405,373   6,516,650 
Balance at September 30, 2017  89,338,555  $16,881,977 
         
Balance at December 31, 2017  90,225,869  $18,244,659 
Stock issuance for services (i)  641,717   1,238,513 
Stock issued due to exercise of options (Note 10)  1,866,996   1,923,922 
Stock issuance for financing, net of costs (ii)  1,861,627   3,966,362 
Balance at September 30, 2018  94,596,209  $25,373,456 
  Number of    
  common  Common 
  stock  stock amount 
Balance at December 31, 2017  90,225,869  $18,244,659 
Stock issuance for services  641,717   1,238,513 
Stock issuance for financing, net of costs  1,861,627   3,966,362 
Stock issuance due to exercise of options  1,866,996   1,923,922 
Balance at September 30, 2018  94,596,209  $25,373,456 
         
Balance at December 31, 2018  97,598,898  $30,410,648 
Stock issuance for services (i and ii)  707,236   792,104 
Stock issuance from financing (iii and iv)  9,337,529   6,690,922 
Stock issuance due to exercise of options  394,735   754,148 
Balance at September 30, 2019  108,038,398  $38,647,822 

 

i.(i)On May 10, 2018,January 14, 2019, the Company issued 641,717settled $75,000 of amounts due to a vendor by issuing 49,342 common shares in accordance withvalued at $55,263 at the date of issuance. The Company recorded a development, commercialization and exclusive distribution agreement with Seraph Biosciences, Inc. and recognized $1,238,513 as a research and development expense in$19,737 gain on the condensed unaudited interim statementssettlement of operations and comprehensive loss.liabilities during the three months ended March 31, 2019;

 

ii.(ii)On May 15, 2018,January 14, 2019, the Company issued 255,815657,894 common shares for grossin satisfaction of $1,000,000 of all remaining milestones under a License and Supply Agreement with a third party. The Company recognized $736,841 as research and development expense, based on the value of the common stock on the date of issuance;

(iii)On January 14, 2019, the Company completed a non-brokered private placement, and issued 2,815,789 common shares. Gross proceeds of $550,000. On June 28, 2018, the Company issued 1,605,812 common shares for gross proceeds of $3,452,496. The$4,280,000 were received prior to December 31, 2018.The Company recorded $23,806$465 of share issuance costs as an offset to capital stock.common stock;

13

 

(iv)On March 28, 2019, the Company completed an underwritten public offering of its common stock pursuant to which the Company sold an aggregate 6,521,740 common shares for gross proceeds of $3,000,000. The Company recorded nil and $588,613 of share issuance costs as an offset to common stock in the three and nine months ended September 30, 2019.

14

Zomedica Pharmaceuticals Corp.
Notes to the condensed unaudited interim consolidated financial statements
For the three and nine months ended September 30, 2019 and 2018
(Stated in United States dollars)

10.12.Stock-based compensation

 

During the three months ended September 30, 2019, nil options were exercised. During the three months ended September 30, 2018, 85,000 options were exercised. During the threenine months ended September 30, 2017, 427,9402019, 394,735 options were exercised. During the nine months ended September 30, 2018, 1,866,996 options were exercised. During the three months ended September 30, 2019, the Company issued 1,500,000 stock options. During the nine months ended September 30, 2017, 925,000 options were exercised and2019, the Company issued 1,815,0007,495,000 stock options, each option entitling the holder to purchase one common share of the Company. During the three and nine months ended September 30, 2018, the Company issued nil options.

 

The continuity of stock options are as follows:

 

  Number of Options  Weighted Avg Exercise Price (CDN$) 
Balance at December 31, 2016  7,975,000   0.84 
Stock options exercised on February 21, 2017  (10,000)  0.25 
Stock options exercised on February 21, 2017  (400,000)  0.05 
Options issued on February 24, 2017  535,000   1.50 
Stock options exercised on May 8, 2017  (7,060)  1.50 
Stock options cancelled on May 17, 2017  (10,000)  1.50 
Stock options exercised on May 23, 2017  (80,000)  0.25 
Stock options exercised on July 6, 2017  (200,000)  0.05 
Stock options exercised on July 17, 2017  (220,000)  0.25 
Options issued on August 14, 2017  1,280,000   2.75 
Stock options exercised on August 29, 2017  (7,940)  1.50 
Stock options exercised on December 19, 2017  (25,000)  0.25 
Stock options exercised on December 19, 2017  (750,000)  1.50 
Balance at December 31, 2017  8,080,000   1.21 
Stock options exercised on January 8, 2018  (124,000)  0.25 
Stock options exercised on January 26, 2018  (100,000)  0.25 
Stock options exercised on March 8, 2018  (50,000)  0.25 
Stock options exercised on March 13, 2018  (176,000)  0.25 
Stock options exercised on March 22, 2018  (50,000)  0.25 
Stock options exercised on March 26, 2018  (240,000)  0.25 
Stock options exercised on March 28, 2018  (325,000)  0.25 
Stock options exercised on March 29, 2018  (562,996)  2.75 
Stock options exercised on April 20, 2018  (154,000)  0.25 
Stock options expired on April 21, 2018  (1,946,000)  0.25 
Stock options cancelled on June 8, 2018  (100,000)  1.50 
Stock options cancelled on June 21, 2018  (400,000)  1.50 
Stock options cancelled on August 14, 2018  (75,000)  2.75 
Stock options exercised on September 27, 2018  (85,000)  1.50 
Stock options cancelled on September 28, 2018  (5,000)  2.75 
Balance at September 30, 2018  3,687,004   1.72 
  Number of options  Weighted avg
exercise price
(US$)(i)
 
Balance at December 31, 2018  422,004  $1.95 
Stock options granted January 10, 2019  5,995,000   1.52 
Stock options expired February 24, 2019  (35,000)  1.12 
Stock options exercised March 8, 2019  (164,473)  1.52 
Stock options exercised March 15, 2019  (164,473)  1.52 
Stock options exercised March 29, 2019  (65,789)  1.52 
Stock options expired May 23, 2019  (10,000)  1.52 
Stock options expired June 16, 2019  (40,000)  1.52 
Stock options cancelled August 13, 2019  (5,000)  1.52 
Stock options expired August 14, 2019  (392,004)  2.07 
Stock options granted August 19, 2019  500,000   0.26 
Stock options granted August 19, 2019  100,000   0.35 
Stock options granted August 19, 2019  100,000   0.45 
Stock options granted August 19, 2019  100,000   0.55 
Stock options granted August 19, 2019  100,000   0.65 
Stock options granted August 19, 2019  100,000   0.75 
Stock options granted September 16, 2019  500,000   0.43 
Balance at September 30, 2019  7,040,265  $1.28 

 

(i) As of the year ended December 31, 2018, the weighted average exercised price in CDN$ was $2.65.

14

10.Stock-based compensation (continued)

 

As at September 30, 2018,2019, details of the issued and outstanding stock options arewere as follows:

 

Grant date Exercise price (CDN$)  Number of options issued and outstanding  Number of vested options outstanding  Weighted avg remaining life (years) 
December 21, 2016  1.50   2,415,000   2,415,000   0.22 
December 21, 2016  1.50   100,000   100,000   0.12 
February 24, 2017  1.50   35,000   35,000   0.40 
February 24, 2017  1.50   500,000   500,000   0.12 
August 14, 2017 (a)  2.75   387,004   387,004   0.87 
August 14, 2017 (a)  2.75   250,000   250,000   0.12 
Grant date   Exercise price
(USD$) 
   Number of
options
    Number of
vested
options 
    Weighted Avg
Remaining Life
(years) 
 
January 10, 2019 $1.52   5,540,265   5,540,265   1.28 
August 19, 2019  0.26   500,000   500,000   1.88 
August 19, 2019  0.35   100,000   100,000   1.88 
August 19, 2019  0.45   100,000   100,000   1.88 
August 19, 2019  0.55   100,000   100,000   1.88 
August 19, 2019  0.65   100,000   100,000   1.88 
August 19, 2019  0.75   100,000   100,000   1.88 
September 16, 2019  0.43   500,000   500,000   1.96 
Balance at September 30, 2019      7,040,265   7,040,265     

15

Zomedica Pharmaceuticals Corp.
Notes to the condensed unaudited interim consolidated financial statements
For the three and nine months ended September 30, 2019 and 2018
(Stated in United States dollars)

12.Stock-based compensation (continued)

 

The fair value of options granted during the three and nine months ended September 30, 2018 and year ended December 31, 20172019 was estimated using the Black-Scholes option pricing model to determine the fair value of options granted using the following assumptions:

 

 February 24, 2017  August 14, 2017 (a)  August 14, 2017 (b)  January 10, 2019 August 19, 2019 September 16, 2019
Volatility  59%  59%  83%  68%   87%   89% 
Risk-free interest rate  0.81%  1.22%  1.22%  2.56%   1.48%   1.74% 
Expected life (years)  2   2   1   2   2   2 
Dividend yield  0%  0%  0%  0   0   0 
Common share price  CDN $1.35   CDN $2.40   CDN $2.40   $1.23   $0.26   $0.42 
Strike price  CDN $1.50   CDN $2.75   CDN $2.75   $1.52   $ 0.26 - $ 0.75   $0.43 
Forfeiture rate  nil   nil   nil   nil   nil   nil 

 

The Company recorded nil$197,988 of stock-based compensation for the three months ended September 30, 20182019 (three months ended September 30, 2017 - $675,941)2018 – nil). The Company recorded $7,288$2,539,092 of stock-based compensation for the nine months ended September 30, 20182019 (nine months ended September 30, 20172018 - $161,590)$7,288). The Company recorded nil in cash receipts due to the exercise of options during the three months ended September 30, 2019. The Company recorded the cash receipt of $98,715 as capital$600,000 and reclassified $154,148 of stock-based compensation to common stock due to the exercise of options during the nine months ended September 30, 2019. The Company recorded the cash receipt of $98,716 and reclassified $34,608 of stock-based compensation to capitalcommon stock due to the exercise of options during the three months ended September 30, 2018. The Company recorded the cash receipt of $1,537,024 as capital stock and reclassified $386,898 of stock-based compensation to capitalcommon stock due to the exercise of options during the nine months ended September 30, 2018.

 

Volatility is determined based on volatilities of comparable companies when the Company does not have its own sufficient trading history. The expected term, which represents the period of time that options granted are expected to be outstanding, is estimated based on an average of the term of the options.

The risk-free rate assumed in valuing the options is based on the Canadian treasury yield curve in effect at the time of grant for the expected term of the option. The expected dividend yield percentage at the date of grant is nil as the Company is not expected to pay dividends in the foreseeable future. The Company has estimated its stock option forfeitures to be nil for the three and nine months ended September 30, 20182019 (three and Ninenine months ended September 30, 20172018 - $nil)nil).

15

 

11.13.Commitments and contingencies

 

There were noOn October 1, 2018, the Company entered into a one-year rental agreement. On September 1, 2019, the Company elected to renew this rental agreement for an additional one-year period, as well as enter into an additional one-year rental agreement. The Company elected not to account for these leases in accordance with ASC 842 as they are for a one-year term. Total future annual lease payments for the premises are as of September 30, 2018.follows:

2019 $12,480 
2020 33,280 
Total $45,760 

16

Zomedica Pharmaceuticals Corp.
Notes to the condensed unaudited interim consolidated financial statements
For the three and nine months ended September 30, 2019 and 2018
(Stated in United States dollars)

 

13.Commitments and contingencies (continued)

On November 26, 2018, the Company entered into a Development and Supply Agreement and as part of this agreement, the Company has contingent future outflows as follows:

1st payment: At the later of the achievement of a future milestone event or September 12, 2019, can decide to receive payment as follows:
°$3,000,000 in cash or
°$1,500,000 in cash and $1.95 million in equity
2nd payment: At the later of the achievement of a future milestone or February 19, 2020 - $2,000,000 in cash.

As at September 30, 2019, neither of the future development milestones related to the above agreement have been met.

On May 10, 2018, the Company entered into a Development, Commercialization and Exclusive Distribution Agreement. As part of the agreement, the Company is required to make the following future milestone payments:

1st payment: $3,500,000 in cash payment upon the achievement of future development milestones
2nd payment: $3,500,000 in equity based on the number of the Company’s common stock determined by dividing the amount due by the volume-weighted average price of the Company’s common stock on the NYSE American exchange over the 10 trading days prior to the achievement of the milestone event.

As at September 30, 2019, neither of the future development milestones related to the above agreement have been met.

From time to time, the Company may be exposed to claims and legal actions in the normal course of business. As at September 30, 2019, and continuing as at November 12, 2019, the Company is not aware of any pending or threatened material litigation claims against the Company, other than as described below.

On November 1, 2019, Heska Corporation (“Heska”) filed a complaint for damages and injunctive relief (the “Complaint”) in the United States District Court for the Middle District of North Carolina, Case 1:19-cv-01108-LCB-JLW, against Qorvo US, Inc. (“Qorvo US”), Qorvo Biotechnologies, LLC (“Qorvo Biotech” and, together with Qorvo US, “Qorvo”) and the Company (collectively with Qorvo, the “Defendants”). The Complaint alleges, among other things, that the Defendants improperly obtained Heska’s trade secrets and confidential information and/or conspired to use improper means to misappropriate Heska’s trade secrets related to an instrument and related consumable products for performing immunoassay analysis of biomarkers and other substances. The Complaint seeks compensatory and exemplary damages, as well as preliminary and permanent injunctive relief to prevent the Defendants from commercializing the Company’s TRUFORMATM diagnostic instrument.

Under the terms of the Development and Supply Agreement, dated November 26, 2018, by and between Qorvo Biotech and the Company (the “Qorvo Agreement”), Qorvo Biotech agreed to indemnify the Company and certain related parties against claims alleging infringement or misappropriation of third-party intellectual property rights, subject to certain limitations and exceptions. Qorvo Biotech has notified the Company that Qorvo Biotech has assumed the defense of the Complaint and will indemnify the Company for losses arising from the Complaint in accordance with the terms of the Qorvo Agreement. Qorvo Biotech has further advised the Company that it intends to mount a vigorous defense to the claims in the Complaint, and that it believes the allegations contained in the Complaint are without merit.

12.14.Financial instruments

 

(a)Fair values

 

The Company follows ASC topic 820, “Fair Value Measurements” which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. The provisions of ASC topic 820 apply to other accounting pronouncements that require or permit fair value measurements. ASC topic 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date; and establishes a three level hierarchy for fair value measurements based upon the transparency of inputs to the valuation of an asset or liability as of the measurement date. Inputs refers broadly to the assumptions that market participants would use in pricing the asset or liability, including assumptions about risk. To increase consistency and comparability in fair value measurements and related disclosures, the fair value hierarchy prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The three levels of the hierarchy are defined as follows:

 

Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities.

 

17

Zomedica Pharmaceuticals Corp.
Notes to the condensed unaudited interim consolidated financial statements
For the three and nine months ended September 30, 2019 and 2018
(Stated in United States dollars)

14.Financial instruments (continued)

Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly for substantially the full term of the financial instrument.

 

Level 3 inputs are unobservable inputs for asset or liabilities.

 

The categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement.

 

(i)The Company calculates expected volatility based on historical volatility of the Company’s peer group that is publicly traded for options.

 

An increase/decrease in the volatility would have resulted in an increase/decrease in the fair value of the options.

The carrying values of cash, trade and other receivable, accounts payable and accrued liabilities and shareholder loans payable approximates their fair values because of the short-term nature of these instruments.

 

(b)Interest rate and credit risk

Interest rate risk is the risk that the value of a financial instrument might be adversely affected by a change in interest rates. The Company does not believe that the results of operations or cash flows would be affected to any significant degree by a sudden change in market interest rates, relative to interest rates on cash and cash equivalents, due to related parties due to the short-term nature of these balances.

The Company is also exposed to credit risk at period end from the carrying value of its cash. The Company manages this risk by maintaining bank accounts with a Canadian Chartered Bank and a U.S. Bank. The Company’s cash is not subject to any external restrictions.

 

16

(c)Foreign exchange risk

None

 

The Company has balances in Canadian dollars that give rise to exposure to foreign exchange (“FX”) risk relating to the impact of translating certain non-U.S. dollar balance sheet accounts as these statements are presented in U.S. dollars. A strengthening U.S. dollar will lead to a FX loss while a weakening U.S. dollar will lead to a FX gain. For each Canadian dollar balance of $1.0 million, a +/- 10% movement in the Canadian currency held by the Company versus the U.S. dollar would affect the Company’s loss and other comprehensive loss by $0.1 million.

 

(d)Liquidity risk

Liquidity risk is the risk that the Company will encounter difficulty raising liquid funds to meet commitments as they fall due. In meeting its liquidity requirements, the Company closely monitors its forecasted cash requirements with expected cash drawdown.

 

18

Zomedica Pharmaceuticals Corp.
Notes to the condensed unaudited interim consolidated financial statements
For the three and nine months ended September 30, 2019 and 2018
(Stated in United States dollars)

14.Financial instruments (continued)

The following are the contractual maturities of the undiscounted cash flows of financial liabilities as at SeptemberJune 30, 20182019 and December 31, 2017:2018:

 

             September 30, 2018          September 30, 2019 
 Less than 3 to 6 6 to 9 9 months Greater than    Less than 3 to 6 6 to 9 9 months Greater than   
 3 months  months  months  1 year  1 year  Total  3 months  months  months  1 year  1 year  Total 
 $ $ $ $ $ $  $ $ $ $ $ $ 
Third parties                                                
Accounts payable and accrued liabilities  1,280,379   -   -   -   -   1,280,379   1,577,525   -   -   -   -   1,577,525 
  1,280,379   -   -   -   -   1,280,379   1,577,525   -   -   -   -   1,577,525 

 

             December 31, 2017          December 31, 2018 
 Less than 3 to 6 6 to 9 9 months Greater than    Less than 3 to 6 6 to 9 9 months Greater than   
 3 months  months  months  1 year  1 year  Total  3 months  months  months  1 year  1 year  Total 
 $ $ $ $ $ $  $ $ $ $ $ $ 
Third parties                                                
Accounts payable and accrued liabilities  828,737   -   -   -   -   828,737   2,376,519   -   -   -   -   2,376,519 
  828,737   -   -   -   -   828,737   2,376,519   -   -   -   -   2,376,519 

 

13.15.Segmented information

 

The Company's operations comprise a single reportable segment engaged in the research, development targeting health and wellness solutions for the companion pet.animal. As the operations comprise a single reportable segment, amounts disclosed in the financial statements for loss for the period, depreciation and total assets also represent segmented amounts. In addition, all of the Company's long-lived assets are in the United States of America (“US”).

 

 September 30,  December 31, 
 September 30, 2018  December 31, 2017  2019  2018 
   $     $   $  $ 
Total assets                
Canada  521,531   3,519,918   431,063   383,567 
US  3,669,115   1,695,904   6,179,961   5,649,952 
                
Total property and equipment        
US  756,823   371,157 
Total US property and equipment  805,218   717,088 
Total US right-of-use asset  1,231,003   - 
  2,036,221   717,088 

 

19

17

 

Zomedica Pharmaceuticals Corp.
Notes to the condensed unaudited interim consolidated financial statements
For the three and nine months ended September 30, 2019 and 2018
(Stated in United States dollars)

14.16.Schedule of expenses

 

 For the three months ended September 30,  For the three months ended September 30, 
 2019  2018 
 

For the three months ended September 30,

2018

  

For the three months ended September 30,

2017

  Research and Professional General and  Research and Professional General and 
 Research and Development  Professional Fees  General and Administrative  Research and Development  Professional Fees  General and Administrative  Development  Fees  Administrative  Development  Fees  Administrative 
                            
Salaries, bonus and benefits $164,267  $-  $454,786  $118,227  $-  $1,136,402  $129,319  $-  $849,458  $164,267  $-  $454,786 
Contracted expenditures  259,947   -   -   156,980   -   -   661,917   -   -   259,947   -   - 
Marketing and investor relations  -   -   53,996   -   -   13,015   -   -   165,837   -   -   53,996 
Travel and accommodation  8,023   -   36,491   6,425   -   49,532   8,327   -   198,993   8,023   -   36,491 
Insurance  20,855   -   76,903   21,900   -   48,373   19,497   -   66,029   20,855   -   76,903 
License fees  -   -   -   -   -   -   -   -   -   -   -   - 
Office  6,665   -   82,416   16,701   -   26,803   11,565   -   80,032   6,665   -   82,416 
Consultants  80,425   293,484   -   58,536   246,192   -   29,343   279,237   -   80,425   293,484   - 
Regulatory  19,247   -   32,904   25,775   -   28,844   31,773   -   26,163   19,247   -   32,904 
Rent  15,396   -   90,463   12,040   -   38,805   -   -   7,603   15,396   -   90,463 
Supplies  55,546   -   6,611   48,911   -   8,951   70,722   -   10,837   55,546   -   6,611 
Total $630,371  $293,484  $834,570  $465,495  $246,192  $1,350,726  $962,463  $279,237  $1,404,952  $630,371  $293,484  $834,570 

 

 For the nine months ended September 30,  For the nine months ended September 30, 
 2019  2018 
 

For the nine months ended September 30,

2018

  

For the nine months ended September 30,

2017

  Research and Professional General and  Research and Professional General and 
 Research and Development  Professional Fees  General and Administrative  Research and Development  Professional Fees  General and Administrative  Development  Fees  Administrative  Development  Fees  Administrative 
                            
Salaries, bonus and benefits $490,706  $-  $1,957,341  $478,231  $-  $2,107,835  $579,110  $-  $4,422,480  $490,706  $-  $1,957,341 
Contracted expenditures  968,159   -   -   516,275   -   5,610   2,474,483   -   -   968,159   -   - 
Marketing and investor relations  -   -   177,151   -   -   116,196   -   -   297,252   -   -   177,151 
Travel and accommodation  13,360   -   228,359   9,383   -   228,317   21,103   -   318,730   13,360   -   228,359 
Insurance  65,099   -   234,646   59,572   -   132,474   76,402   -   179,367   65,099   -   234,646 
License fees  1,738,513   -   -   -   -   -   5,936,841   -   -   1,738,513   -   - 
Office  41,312   -   220,823   28,569   -   76,967   31,162   -   216,521   41,312   -   220,823 
Consultants  169,613   1,001,886   -   226,985   942,385   -   178,223   1,230,151   -   169,613   1,001,886   - 
Regulatory  57,422   -   226,604   77,325   -   100,979   95,418   -   76,333   57,422   -   226,604 
Rent  31,047   -   176,501   31,303   -   121,231   -   -   19,483   31,047   -   176,501 
Supplies  190,101   -   21,807   158,536   -   36,750   162,603   -   27,495   190,101   -   21,807 
Total $3,765,332  $1,001,886  $3,243,232  $1,586,179  $942,385  $2,926,361  $9,555,345  $1,230,151  $5,557,661  $3,765,332  $1,001,886  $3,243,232 

 

15.17.Capital risk management

 

The capital of the Company includes equity, which is comprised of issued common capital stock, additional paid-in capital, and accumulated deficit. The Company's objective when managing its capital is to safeguard the ability to continue as a going concern in order to provide returns for its shareholders, and other stakeholders and to maintain a strong capital base to support the Company's core activities.

 

20

18

 

Zomedica Pharmaceuticals Corp.
Notes to the condensed unaudited interim consolidated financial statements
For the three and nine months ended September 30, 2019 and 2018
(Stated in United States dollars)

 

16.18.Loss per share

 

 

For the three months ended

September 30,

 

For the nine months ended

September 30,

  For the three months ended September 30, For the nine months ended September 30, 
 2018  2017  2018  2017  2019  2018  2019  2018 
                     
Numerator                                
Net loss for the period $1,910,278  $2,080,682  $8,226,005  $5,501,788  $2,845,679  $1,910,278  $16,927,016  $8,226,005 
Denominator                                
Weighted average shares - basic  94,514,905   88,844,534   92,534,667   86,708,499   108,038,398   94,514,905   105,711,459   92,534,667 
Stock options  -   -   -   -   -     -     -     -   
Denominator for diluted loss per share  94,514,905   88,844,534   92,534,667   86,708,499   108,038,398   94,514,905   105,711,459   92,534,667 
                                
Loss per share - basic and diluted $(0.02) $(0.02) $(0.09) $(0.06) $(0.03) $(0.02) $(0.16) $(0.09)

 

For the above mentionedabove-mentioned periods, the Company had securities outstanding which could potentially dilute basic earnings per share in the future but were excluded from the computation of diluted loss per share in the periods presented, as their effect would have been anti-dilutive.

17.19.Related party transactions and key management compensation

 

Key management personnel are comprised of the Company’s directors and executive officers. In addition to their salaries, key management personnel also receive share-based compensation. Key management personnel compensation is as follows:

 

 

For the three months ended

September 30,

 

For the nine months ended

September 30,

  For the three months ended September 30, For the nine months ended September 30, 
 2018  2017  2018  2017  2019  2018  2019  2018 
Salaries and benefits, including bonuses $324,784  $329,314  $1,046,449  $954,311  $251,737  $324,784  $887,635  $1,046,449 
Stock-based compensation  -   598,595   -   749,615   100,002   -     1,744,327   -   
Total $324,784  $927,909  $1,046,449  $1,703,926  $351,739  $324,784  $2,631,962  $1,046,449 

 

19

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

 

Item 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS.OPERATION

 

The following discussion and analysis of our financial condition and results of operations should be read together with our financial statements and the related notes and the other financial information included elsewhere in this Quarterly Report. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those discussed below and elsewhere in this Quarterly Report, and those set forth in our most recent Annual Report on Form 10-K particularly those under “Risk Factors” discussed below and in our most recent Annual Report on Form 10-K.

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-lookingamended, that are based on management’s beliefs and assumptions and on information currently available to management. Some of the statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentionsunder “Risk Factors,” “Management’s Discussion and future performance,Analysis of Financial Condition and involve knownResults of Operations” and unknown risks, uncertainties“Business” and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by suchelsewhere in this Form 10-Q contain forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. YouIn some cases, you can identify these forward-looking statements through our use of words such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

 

There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to:

 

the success, cost and timing of our research and development activities, validation studies and pivotal trials, including with respect to our lead product candidates, ZM-020, ZM-017, ZM-007, ZM-012, ZM-006 and ZM-011;
·the success, cost and timing of our research and development activities, validation studies and pivotal trials, including with respect to our lead product candidates, TRUFORMA™, ZM-017, ZM-022, ZM-020, ZM-007, ZM-012 ZM-006, and ZM-011;

 

our ability to obtain regulatory approval from the FDA-CVM and/or the USDA-CVB for our pharmaceutical and diagnostic product candidates, as applicable;
·our ability to obtain regulatory approval from the Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM) and/or the USDA Center for Veterinary Biologics (USDA-CVB) for our pharmaceutical and diagnostic product candidates, as applicable;

 

our ability to obtain funding for our operations;
·our ability to obtain funding for our operations;

 

the ability of our CROs to appropriately conduct our safety studies and certain development activities;
·our obligation to pay a portion of our “net sales” to holders of our Series 1 Preferred Shares;

 

the ability of our CMOs to manufacture and supply our product candidates in accordance with cGMP and our clinical needs;
·our ability to raise additional capital, considering the significant obligations under our Series 1 Preferred Shares;

 

our plans to develop and commercialize any product candidates for which we receive regulatory approval;
·the ability of our contract research organizations to appropriately conduct our safety studies and certain development activities;

 

our ability to develop and commercialize product candidates that can compete effectively against the product candidates developed and commercialized by our competitors;
·the ability of our contract manufacturing organizations to manufacture and supply our product candidates in accordance with current Good Manufacturing Practices and our clinical needs;

 

the size and growth of the veterinary diagnostics and therapeutics markets;
·the ability of our contract manufacturing organizations to manufacture and supply our product candidates in accordance with current Good Manufacturing Practices and our clinical needs;

 

our ability to obtain and maintain intellectual property protection for our current and future product candidates;
·our plans to develop and commercialize our product candidates;

 

·our ability to develop and commercialize product candidates that can compete effectively against the product candidates developed and commercialized by our competitors or that can meet the current standards of care (including human generic drugs);
regulatory developments in the United States;
·the size and growth of the veterinary diagnostics and therapeutics markets;

 

20·our ability to obtain and maintain intellectual property protection for our current and future product candidates;

 

the loss of key scientific or management personnel;
·regulatory developments in the United States;

 

our expectations regarding the period during which we will be an “emerging growth company” under the JOBS Act;
·the loss of key scientific or management personnel;

 

the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; and
·our expectations regarding the period during which we will be an “emerging growth company” under the JOBS Act;

 

our status as a PFIC for U.S. federal income tax purposes.
·the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; and

·our status as a “passive foreign investment company” for U.S. federal income tax purposes.

 

The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipate in our forward-looking statements. Please see “Risk Factors” below and in our most recent Annual Report on Form 10-K for additional risks which could adversely impact our business and financial performance.

 

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by reference into this report. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.otherwise, except as required by law. We have expressed our expectations, beliefs and projections in good faith, and we believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs or projections will result or be achieved or accomplished.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATION

Overview

 

We are a development stage veterinary diagnostic and pharmaceutical company creating products for companion animals (canine, feline, and equine) by focusing on the unmet needs of clinical veterinarians. We believe that we have identified and are developing diagnostics and therapeutics that have the potential to significantly improve the diagnosis and treatment of various diseases affecting companion animals. We believe that there are significant unmet medical needs for pets, and that the pet diagnostic and therapeutic segments of the animal health industry are likely to grow substantially as new diagnostic tools and treatments are identified, developed, and marketed specifically for companion animals.

 

Together with our strategic partners, we are developing three diagnostic platforms, a Bulk Acoustic Wave sensor-based veterinary point-of-care diagnostic platform for performing immunodiagnostic testing, a Raman spectroscopy-based point-of-care diagnostic platform for the detection of pathogens, and liquid biopsy assays for the detection of cancer, andalong with related consumables. TheWe believe that the regulatory pathway to obtain pre-market regulatory approval of companion animal diagnostics is significantly shorter than for similar diagnostic products intended for human use. In certain cases, pre-market regulatory approvalclearance may be unnecessary, depending on the intended use of the diagnostic.

 

We also have identified a number ofseveral drugs that have proven safe and effective in humans that we are developing for use in companion animals.canines and felines. We believe this development approach enables us to reduce the risks associated with obtaining regulatory approval for unproven product candidates and shortens the development timeline necessary to bring our product candidates to market. We have four drug product candidates in early development and have identified several other potential product candidates for further investigation.


In addition, we are investigating the development of alternative drug delivery technologies for our drug product candidates. Many of the human-approved therapeutics used in companion animals are only available in pill or injectable form. However, it can be difficult to give a companion animal an injection or to assure that the animal has swallowed a pill. As a result, we believe that compliance with treatment regimens is a significant problem for veterinarians and pet owners. The challenges associated with medicating pets are unique, and we believe that developing product candidates that can be easily taken by the pet or easily administered by pet owners will help increase compliance.

 

21

We are a development-stage company with no products approved for marketing and sale, and we have not generated any revenue. We have incurred significant net losses since our inception. We incurred net losses of $1,910,278$2,845,679 and $2,080,682$1,910,278 for the three months ended September 30, 20182019 and September 30, 2017,2018, respectively, and $8,226,005$16,927,016 and $5,501,788$8,226,005 for the nine months ended September 30, 20182019 and September 30, 2017,2018, respectively. These losses have resulted principally from costs incurred in connection with investigating and developing our product candidates, research and development activities and general and administrative costs associated with our operations. As of September 30, 2018,2019, we had an accumulated deficit of $23,852,105$49,200,803 and cash and cash equivalents of $526,817.$2,487,651.

 

For the foreseeable future, we expect to continue to incur losses, which will increase significantly from historical levels as we expand our product development activities, commercialize them if they do not require U.S. Food and Drug Administration’s Center for Veterinary Medicine, or FDA-CVM, pre-market approval, and seek regulatory approvals for our product candidates where required from the FDA-CVM or the United States Department of Agriculture Center for Veterinary Biologics, or the USDA-CVB.

 

For further information on the regulatory, business and product pipeline, please see the “Business” section of thethis Annual Report on Form 10-K. For further information on the risk factors, please see the “Risk Factors” section of the Annual Report on Form 10-K.

 

Revenue

 

We do not have any products approved for sale, have not generated any revenue from product sales since our inception and do not expect to generate any revenue from the sale of products in the near future. If our development efforts result in clinical success and regulatory approval or collaboration agreements with third parties for any of our product candidates, we may generate revenue from those product candidates.

 

Operating Expenses

 

The majorityMost of our operating expenses to date have been for the general and administrative activities related to general business activities, capital market activities and stock-based compensation, and research and development activities related to our lead product candidates.

 

Research and Development Expense

 

All costs of research and development are expensed in the period in which they are incurred. Research and development costs primarily consist of salaries and related expenses for personnel, fees paid to consultants, outside service providers, professional services, license fees, travel costs and materials used in clinical trials and research and development.

 

We have a point-of-care diagnosticbiosensor platform, ZM-020,TRUFORMA™ that we are developing for the detectiondiagnosis and treatment management of pathogens in urinedisorders such as thyroid and fecal samples, andadrenal disorders, a non-invasive diagnostic assay or blood test, ZM-017, that we are developing as an aid for veterinarians in diagnosing cancer in canines.canines, and a diagnostic instrument and related assays, for the detection of pathogens in urine and fecal samples at the point-of-care.

 

We have four drug product candidates in development. Our lead drug product candidate is ZM-007, an oral suspension formulation of metronidazole targeting the treatment of acute diarrhea in small dog breeds and puppies under nine pounds or four kilograms. Our second drug product candidate is ZM-012, a novel tablet formulation of metronidazole, most commonly known as Flagyl™, its human pharmaceutical brand name, and a complementary formulation to ZM-007, targeting the treatment of acute diarrhea in larger dogs. Our third drug product candidate is ZM-006, a transdermal gel formulation of methimazole, most commonly known as Tapazole™, its human pharmaceutical brand name, and Felimazole™, its feline pharmaceutical brand name, targeting hyperthyroidism in cats. Our fourth drug product candidate is ZM-011, a transdermal gel formulation of fluoxetine, most commonly known as Prozac®Prozac™, its human pharmaceutical brand name.

We typically use our employee and infrastructure resources across multiple development programs. We track outsourced development costs by product candidate. We allocate personnel and other internal costs related to development of ZM-020 and ZM-017.

 

22

General and Administrative Expense

 

General and administrative expense consists primarily of personnel costs, including salaries, related benefits and stock-based compensation for employees, consultants and directors. General and administrative expenses also include rent and other facilities costs and professional and consulting fees for legal, accounting, tax services and other general business services.

 

Professional Fees

 

Professional fees include attorney’s fees, accounting fees and consulting fees incurred in connection with product investigation and analysis, regulatory analysis, government relations, audit, securities offerings, investor relations, and general corporate and intellectual property advice.

 

Income Taxes

 

As of December 31, 2017,2018, we had net operating loss carryforwards for federal and state income tax purposes of $5,008,180$11,522,620 and non-capital loss carryforwards for Canada of approximately $6,526,850 respectively,$13,353,870, which will begin to expire in fiscal year 2035. According to newly released IRS regulations, net operating losses generated after 2017 do not expire. However, we2036. We have evaluated the factors bearing upon the realizationrealizability of our deferred tax assets, which are comprised principally of net operating loss carryforwards and non-capital loss carryforwards. We concluded that, due to the uncertainty of realizing any tax benefits as of December 31, 2017 and forward,2018, a valuation allowance iswas necessary to fully offset our deferred tax assets.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

Our management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP. The preparation of our consolidated financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, and revenue, costs and expenses and related disclosures during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments, including those described below. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

 

While our significant accounting policies are more fully described in Note 3 of the notes to our consolidated financial statements appearing elsewhere in this document, we believe that the estimates and assumptions involved in the following accounting policies may have the greatest potential impact on our financial statements.

 

JOBS Act

 

The Jumpstart Our Business Startups Act, or the JOBS Act, contains provisions that, among other things, reduce certain reporting requirements for an “emerging growth company.” We have irrevocably elected not to avail ourselves of the JOBS Act provision that an emerging growth company may delay adopting new or revised accounting standards until such times as those standards apply to private companies.

 

In addition, we are in the process of evaluating the benefits of relying on the other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, if as an “emerging growth company” we choose to rely on such exemptions, we may not be required to, among other things, (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404, and (ii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis). These exemptions will apply until December 31, 2022 or until we no longer meet the requirements of being an “emerging growth company,” whichever is earlier.

23

Use of Estimates

 

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the year. Actual results could differ from those estimates.

 

Areas where significant judgment is involved in making estimates are: the determination of the functional currency; the fair values of financial assets and liabilities; the determination of fair value of stock-based compensation; the useful lives and recoverability of property and equipment; deferred income taxes and forecasting future cash flows for assessing the going concern assumption.

 

Research and Development Costs

 

Research and development expenses comprise costs incurred in performing research and development activities, including salaries and benefits, safety and efficacy studies and contract manufacturing costs, contract research costs, patent procurement costs, materials and supplies and occupancy costs. Research and development activities include internal and external activities associated with research and development studies of current product candidates and advancing product candidates towards a goal of obtaining regulatory approval to manufacture and market the product candidate.

 

Research and development costs related to continued research and development programs are expensed as incurred in accordance with ASC topic 730.

 

Translation of Foreign Currencies

 

The functional currency, as determined by management, is U.S. dollars, which is also our reporting currency. Transactions denominated in currencies other than U.S. dollars and the monetary value of assets and liabilities are translated at the period end exchange rates. Revenue and expenses are translated at rates of exchange prevailing on the transaction dates. All of the exchange gains or losses resulting from these other transactions are recognized in the consolidated statements of operations and comprehensive loss.

 

Stock-Based Compensation

 

We measure the cost of equity-settled transactions by reference to the fair value of the equity instruments at the date at which they are granted if the fair value of the goods or services received by us cannot be reliably estimated.

 

We calculate stock-based compensation using the fair value method, under which the fair value of the options at the grant date is calculated using the Black-Scholes Option Pricing Model, and subsequently expensed over the vesting period of the option. The provisions of our stock-based compensation plans do not require us to settle any options by transferring cash or other assets, and therefore we classify the awards as equity. Stock-based compensation expense recognized during the period is based on the value of stock-based payment awards that are ultimately expected to vest. We estimate forfeitures at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Volatility is determined based on volatilities of comparable companies aswhen the Company does not have its own trading history. The expected term, which represents the period of time that options granted are expected to be outstanding, is estimated based on an average of the term of the options. The risk-free rate assumed in valuing the options is based on the Canadian treasury yield curve in effect at the time of grant for the expected term of the option. The expected dividend yield percentage at the date of grant is Nilnil as we are not expected to pay dividends in the foreseeable future.

 

24

Loss Per Share

 

Basic loss per share, or EPS, is computed by dividing the loss attributable to common shareholders by the weighted average number of common shares outstanding. Diluted EPS reflects the potential dilution that could occur from common shares issuable through the exercise or conversion of stock options, restricted stock awards, warrants and convertible securities. In certain circumstances, the conversion of options, warrants and convertible securities are excluded from diluted EPS if the effect of such inclusion would be anti-dilutive.


The dilutive effect of stock options is determined using the treasury stock method. Stock options and warrants to purchase our common shares issued during the period were not included in the computation of diluted EPS, as the effect would be anti-dilutive.

 

Comprehensive Loss

 

We follow ASC topic 220. This statement establishes standards for reporting and display of comprehensive (loss) income and its components. Comprehensive loss is net loss plus certain items that are recorded directly to shareholders' equity. We currently have no other comprehensive loss items. 

 

Results of Operations

 

Three and nine months ended September 30, 20182019 compared to three and nine months ended September 30, 20172018

 

Our results of operations for the three and nine months ended September 30, 20182019 and September 30, 20172018 are as follows:

 

  Three months ended September 30, Nine months ended September 30,
   2019  2018 Change  2019  2018 Change
  $ $ $ % $ $ $ %
Expenses                                
Research and development  962,463   630,371   332,092   53%  9,555,345   3,765,332   5,790,013   154%
General and administrative  1,404,952   834,570   570,382   68%  5,557,661   3,243,232   2,314,429   71%
Professional fees  279,237   293,484   (14,247)  -5%  1,230,151   1,001,886   228,265   23%
Amortization - right-of-use asset  127,345   -   127,345   N/A   382,035   -   382,035   N/A 
Amortization - intangible  273   431   (158)  -37%  810   1,810   (1,000)  -55%
Depreciation  70,096   86,162   (16,066)  -19%  201,075   150,320   50,755   34%
Loss from operations  2,844,366   1,845,018   999,348   54%  16,927,077   8,162,580   8,764,497   107%
Loss on fixed assets  -   69,382   (69,382)  N/A   1,308   69,382   (68,074)  -98%
Interest expense  -   -   -   N/A   18,338   -   18,338   N/A 
Gain on settlement of liabilities  -   -   -   N/A   (19,737)  -   (19,737)  N/A 
Foreign exchange gain  1,313   (4,122)  5,435   -132%  30   (5,957)  5,987   -101%
Loss before income taxes  2,845,679   1,910,278   935,401   49%  16,927,016   8,226,005   8,701,011   106%
                                 
Income tax expense  -   -   -   N/A   -   -   -   N/A 
                                 
Net loss and comprehensive loss  2,845,679   1,910,278   935,401   49%  16,927,016   8,226,005   8,701,011   106%

  Three months ended September 30,  Nine months ended September 30, 
  2018  2017  Change  2018  2017  Change 
    $     $     $     %     $     $     $     %  
Expenses                                
Research and development  630,371   465,495   164,876   35%  3,765,332   1,586,179   2,179,153   137%
General and administrative  834,570   1,350,726   (516,156)  -38%  3,243,232   2,926,361   316,871   11%
Professional fees  293,484   246,192   47,292   19%  1,001,886   942,385   59,501   6%
Amortization  431   699   (268)  -38%  1,810   2,098   (288)  -14%
Depreciation  86,162   22,903   63,259   276%  150,320   65,994   84,326   128%
Loss from operations  1,845,018   2,086,015   (240,997)  -12%  8,162,580   5,523,017   2,639,563   48%
                                 
Gain on settlement of liabilities  -   -   -   N/A   -   (5,000)  5,000   N/A 
Loss on sale of fixed assest  69,382       69,382   100%  69,382   -   69,382   100%
Foreign exchange gain  (4,122)  (5,333)  1,211   -23%  (5,957)  (16,229)  10,272   -63%
Loss before income taxes  1,910,278   2,080,682   (170,404)  -8%  8,226,005   5,501,788   2,724,217   50%
                                 
Income tax expense  -   -   -   N/A   -   -   -   N/A 
                                 
Net loss and comprehensive loss  1,910,278   2,080,682   (170,404)  -8%  8,226,005   5,501,788   2,724,217   50%

Revenue

 

We did not generate any revenue during the three and nine months ended September 30, 20182019 and September 30, 2017.2018.

 

25

Research and Development

 

Research and development expense for the three months ended September 30, 20182019 was $630,371$962,463 compared to $465,495$630,371 for the three months ended September 30, 2017,2018, an increase of $164,876$332,092 or 35%53%. The increase was primarily due to an increase in contracted expenditures of $102,967, salaries, bonus and benefits$401,970 related to the development of $46,038 and consulting fees of $21,889.the five assays for TRUFORMATM.

 

Research and development expense for the nine months ended September 30, 20182019 was $3,765,332$9,555,345 compared to $1,586,179$3,765,332 for the nine months ended September 30, 2017,2018, an increase of $2,179,153$5,790,013 or 137%154%. The increase was primarily due to increases in license fees of $4,198,328, and contracted expenditures of $1,506,324. The license fees increase related to $5,000,000 of expenses recognized upon the achievement of development milestones relating to TRUFORMA™ under our development and supply agreement with Qorvo Biotechnologies, LLC (“Qorvo”), and $736,841 of additional milestone expenses relating to our development of ZM-017 under our license and supply agreement with Celsee Diagnostics, Inc. The increase was partially offset by no recurrence from the 2018 period of an up-front licensing fee relatedof $1,738,513 to Seraph Biosciences, Inc. (“Seraph”), upon the signingexecution of aour development, commercialization and exclusive distribution agreement, with Seraph Biosciences, Inc.and $333,247 of $1,738,513, and accrued paymentsadditional development fees due to Seraph for previously incurred development costs of $333,247 included in contracted expenditures.Seraph. The up-front licensing fee representedcontract expenditures increase related to the issuance of unregistered common shares having a value of $1,238,513 and a cash payment of $500,000. Other significant increases of expenditures include contracted expenditures of $451,885. Overall there was an increased level of lab activities, including in vitro and in vivo work, to support the further development of our product candidates ZM-017, ZM-020, ZM-007, ZM-012, ZM-006 and ZM-011. We expect that our R&D expenditures in 2018 will be significantly higher than in 2017, due to the upfront and milestone payments of licensed technologies, initiation of pilot studies related to our four investigational new animal drug applications, work related to verification and validation of ZM-020 and ZM-017, and additional veterinary pharmaceutical candidates, diagnostic developments and technologies.five assays for TRUFORMATM.


General and Administrative

 

General and administrative expense for the three months ended September 30, 20182019 was $834,570$1,404,952, compared to $1,350,728$834,570 for the three months ended September 30, 2017, a decrease2018, an increase of $516,156$570,382 or 38%68%. The decreaseincrease was primarily due to the prior period stock-basedan increase in salaries, bonus and benefits of $394,673, which included share-based compensation expensesexpense of $675,940 primarily$197,988 as a result of the granting of options to purchase an aggregate of 1,280,0001,500,000 common shares, in August 2017all of which 1,223,750 vested immediately upon the datedates of grant. In the three months ended September 30, 2018 there was no stock-based compensation grant of stock options. This decrease was alsoOther increases in salaries, bonus and benefits are due to increases in sales, marketing and other administrative salaries and benefits. Travel and accommodation increased by $162,502 and marketing and investor relations increased by $111,841, which were partially offset by an increase in office expenserent decrease of $55,613 and rent expense$82,860 which was reclassified to amortization of $51,658 due to the expansion of our laboratory and office space, and insurance costs of $28,530 for increased Directors and Officers Insurance premiums.right-of-use asset.

 

General and administrative expense for the nine months ended September 30, 20182019 was $3,243,232,$5,557,661, compared to $2,926,361 for the nine months ended September 30, 2017, an increase of $316,871 or 11%. After adjusting for the prior period stock-based compensation expense of $837,531 the increase$3,243,232 for the nine months ended September 30, 2018, was $1,168,822.an increase of $2,314,429 or 71%. The increase was primarily due to ana $2,465,139 increase toin salaries, bonus and benefits, (excluding stock-basedwhich included share–based compensation expense)expense of $701,310 related to$2,539,092. After adjusting for the addition of personnel, the addition ofshare-based compensation expense, general and administrative expense decreased $224,663 or 7%, primarily as a Chief Commercial Officer, a Vice President of Sales and accrued severance to a former officerresult of the Company. Other increased expenses included office expensereclassification of $143,856,rent to amortization of right-of-use asset of $254,690 and regulatory expensefees decrease of $125,625,$150,271, partially offset by marketing and insurance costsinvestor relations increase of $102,172. We expect that G&A expense will$120,101 and travel and accommodation increase in 2018 and future periods as we increase our level of activity.$90,371.

 

Professional Fees

 

Professional fees for the three months ended September 30, 20182019 were $293,484$279,237, compared to $246,192$293,484 for the three months ended September 30, 2017, an increase2018, a decrease of $47,292$14,247 or 19%5%. Professional fees for the 2018 period consisted primarily ofThe decrease was due to a reduction in legal and consulting fees incurred in connectionassociated with preparationSEC and completion of additional SEC filings and updates, and costs incurred in being a public company across two jurisdictions, Canada and U.S.related filings.

 

Professional fees for the nine months ended September 30, 20182019 were $1,001,886$1,230,151, compared to $942,385$1,001,886 for the nine months ended September30, 2017,September 30, 2018, an increase of $59,501$228,265 or 6%23%. Professional fees forThe increase was primarily due to increased expenses related to the 2018 period consisted primarilyfiling of consulting fees incurred in connection with preparationour S-3 resale registration statement and completion of additional SEC filings and updates, and costs incurred in being a public company across two jurisdictions, Canada and U.S.our S-8 registration statement.

 

26

Net Loss

 

Our net loss for the three months ended September 30, 20182019 was $1,910,278$2,845,679 or $0.02$0.03 per share, compared with a net loss of $2,080,682$1,910,278 or $0.02 per share, for the three months ended September 30, 2017,2018, an increase of $170,404$935,401 or 8%49%. The net loss in each period was attributed to the matters described above.

 

Our net loss for the nine months ended September 30, 20182019 was $8,226,005$16,927,016 or $0.09$0.16 per share, compared with a net loss of $5,501,788,$8,226,005 or $0.06$0.09 per share, for the nine months ended September 30, 2017, an increase of $2,724,217$8,701,011 or 50%106%. The net loss in each period was attributed to the matters described above. We expect to continue to record net losses in future periods until such time as we have sufficient revenue from our product candidates to offset our operating expenses.

 

Cash Flows

 

Three and nine months ended September 30, 20182019 compared to three and nine months ended September 30, 20172018

 

The following table shows a summary of our cash flows for the periods set forth below:

 

 Three months ended September 30, Nine months ended September 30,  Three months ended September 30, Nine months ended September 30,
 2018  2017  Change  2018  2017  Change  2019 2018 Change 2019 2018 Change
 $ $ $ % $ $ $ %  $ $ $ % $ $ $ %
Cash flows used in operating activities  (3,371,059)  (1,443,198)  (1,927,861)  134%  (7,819,347)  (5,108,962)  (2,710,385)  53%  (3,910,078)  (3,371,059)  (539,019)  16%  (13,767,933)  (7,819,347)  (5,948,586)  76%
Cash flows from financing activities  86,388   3,361,429   (3,275,041)  -97%  5,503,385   6,610,122   (1,106,737)  -17%
Cash flows (used) from financing activities  (1,414)  86,388   (87,802)  -102%  14,972,319   5,503,385   9,468,934   172%
Cash flows used in investing activities  (467,675)  (4,775)  (462,900)  9694%  (605,368)  (164,576)  (440,792)  268%  (582,437)  (467,675)  (114,762)  25%  (657,000)  (605,368)  (51,632)  9%
Increase (decrease) in cash  (3,752,346)  1,913,456   (5,665,802)  -296%  (2,921,330)  1,336,584   (4,257,914)  -319%
Increase in cash  (4,493,929)  (3,752,346)  (741,583)  20%  547,386   (2,921,330)  3,468,716   -119%
Cash and cash equivalents, beginning of period  4,279,163   2,649,808   1,629,355   61%  3,448,147   3,226,680   221,467   7%  6,981,580   4,279,163   2,702,417   63%  1,940,265   3,448,147   (1,507,882)  -44%
Cash and cash equivalents, end of period  526,817   4,563,264   (4,036,447)  -88%  526,817   4,563,264   (4,036,447)  -88%  2,487,651   526,817   1,960,834   372%  2,487,651   526,817   1,960,834   372%


Operating Activities

 

Net cash used in operating activities for the three months ended September 30, 20182019 was $3,371,059$3,910,078, compared to $1,443,196 for the three months ended September 30, 2017, an increase of $1,927,861 or 134%. The increase resulted primarily from our net loss of $1,910,278$3,371,059 for the three months ended September 30, 2018, compared toan increase of $539,019 or 16%. The increase in net cash used in operating activities resulted primarily from an increase in our net loss, cash used in decreasing accounts payable and accrued liabilities of $2,080,682 for the three months ended September 30, 2017, a decrease$1,378,710 and cash used in increasing prepaid expenses of $170,404 or 8%. The largest uses$122,315, partially offset by non-cash impacts of cash stemmed from an amended lease agreement for additional laboratorystock-based compensation of $197,988, amortization – right-of-use asset of $127,345 and office space for our headquarters in Ann Arbor, Michigan in which we deposited $1,269,073 in rent for the entire 43-month lease term. Other significant increases in usesdepreciation of cash include an increase in salaries, bonus and benefits as we had 22 employees at September 30, 2018, compared to 20 employees at September 30, 2017.$70,096.

 

Net cash used in operating activities for the nine months ended September 30, 20182019 was $7,819,347$13,767,933, compared to $5,108,962 for the nine months ended September 30, 2017, an increase of $$2,710,385 or 53%. The increase resulted primarily from our net loss of $8,226,005$7,819,347 for the nine months ended September 30, 2018, comparedan increase of $5,948,586 or 76%. The largest use of cash in the current period was the payment of $5,000,000 upon the achievement of development milestones relating to TRUFORMA™ under our development and supply agreement with Qorvo. Other increases in cash used in operating activities resulted primarily from other increases in our net loss, cash used in decreasing accounts payable and accrued liabilities of $5,501,788 for the nine months ended September 30, 2017, an increase of $2,724,217 or 50%. The largest uses of cash stemmed from the Seraph up-front licensing fee cash payment of $500,000 and we entered into an amended lease agreement as discussed above. Other significant increases in uses of cash include an increase in salaries, bonus and benefits as we had 22 employees at September 30, 2018, compared to 20 employees at September 30, 2017. These increases in uses of cash were$798,994, partially offset by sourcesnon-cash impacts of cash fromstock-based compensation of $2,539,092, stock issued for services of $792,104, amortization – right-of-use asset of $382,035, depreciation of $201,075 and stock-based compensation for a totalcash provided by decreasing prepaid expenses of $1,245,801.$140,695.

 

Net cash used in operating activities for the three and nine months ended September 30, 20172018 was $1,443,196$3,371,059, and $5,108,962$7,819,347, which resulted primarily from our net loss of $2,080,682$1,910,278 and $5,501,788.$8,226,005, respectively. The largest usesuse of cash were for employee salaries, bonusstemmed from increases in deposits of $1,281,617 and benefits, professional fees and consulting expenses related to the preparation of our initial U.S. registration statement, and work on our application to list our common shares on the NYSE American.$1,311,463, respectively.

 

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Financing Activities

 

Net cash provided byused in financing activities for the three months ended September 30, 20182019 was $86,388$1,414, compared to net cash provided byfrom financing activities of $3,361,428 for the three months ended September 30, 2017, a decrease of $3,275,041 or 97%. The decrease was primarily due to a nil cash proceeds from financing$86,388 for the three months ended September 30, 2018 a decrease of $87,802 or 102%. The decrease in cash used from financing activities resulted primarily from a reduction in financing activities as compared to $3,320,000 for the three months ended September 30, 2017. Other financing activities included the exercise of stock options for $98,716 for the three months ended September 30, 2018, compared to $60,655 for the three months ended September 30, 2017.prior period.

 

Net cash provided byfrom financing activities for the nine months ended September 30, 20182019 was $5,503,385$14,972,319, compared to net cash provided by financing activities of $6,610,122 for the nine months ended September 30, 2017, a decrease of $1,106,737 or 17%. The decrease was primarily due to cash proceeds from financing for $4,002,496$5,503,385 for the nine months ended September 30, 2018 compared to $6,570,000 for the nine months ended September 30, 2017. Otheran increase of $9,468,934 or 172%. The increase in cash from financing activities includedresulted primarily from $12,000,000 in proceeds from the private sale of preferred shares, $3,000,000 in proceeds from the underwritten public offering of common stock, net of financing costs, and $600,000 in proceeds from the exercise of stock options for $1,537,024 for the nine months ended September 30, 2018, compared to $100,198 for the nine months ended September 30, 2017.options.

 

Net cash provided byfrom financing activities for the three and nine months ended September 30, 20172018 was $3,361,428$86,388 and $6,610,122,$5,503,385, which relates primarily to the sale of $3,320,000 and $6,570.000 of our common shares andresulted from cash proceeds from financing and the exercise of stock options for $60,655 and $100,198 respectively.options.

 

Investing Activities

 

Net cash used in investing activities for the three months ended September 30, 20182019 was $467,675$582,437, compared to $4,775$467,675 for the three months ended September 30, 2017,2018, an increase of $462,900$114,762 or 9,694%25%. The increase in net cash used in investing activities resulted primarily from costs associated with the digital data platform, the construction of marketing assets, and the capitalization of integration costs associated with the implementation of an ERP system, compared to the prior period build-out of the new laboratoryoffice space and purchases of lab and office spaceequipment for our Ann Arbor facility completed in Ann Arbor.the three months ended September 30, 2018.


Net cash used in investing activities for the nine months ended September 30, 20182019 was $605,368,$657,000, compared to $164,576$605,368 for the nine months ended September 30, 2017,2018, an increase of $440,792$51,632 or 268%.The9%. The increase resulted primarily from the completion of build-out of the new laboratory and office space in Ann Arbor.

Netnet cash used in investing activities resulted primarily from costs associated with the digital data platform, the construction of marketing assets, and the capitalization of integration costs associated with the implementation of an ERP system, compared to the prior period build-out of office space and purchases of lab and office equipment for our Ann Arbor facility completed in the three and nine months ended September 30, 2017 was $4,775 and $164,576 which primarily resulted from leasehold improvements and the purchase of furniture and equipment for the initial office space in Ann Arbor.2018.

 

Liquidity and Capital Resources

 

We have incurred losses and negative cash flows from operations and have not generated any revenue since our inception in May 2015. As of September 30, 2018,2019, we had an accumulated deficit of $23,852,105.$49,200,803. We have funded our working capital requirements primarily through the sale of our preferred and common shares and the exercise of stock options. At

As at September 30, 2018, we2019, the Company had cash of $2,487,651, prepaid expenses and cash equivalentsdeposits of $526,817.

Working$1,497,425, and accounts receivable of $75,992. Current assets amounted to $4,061,068 with current liabilities of $1,577,525, resulting in working capital (defined as current assets minus current liabilities) of $2,483,543.

In the second quarter of 2019, we sold $12,000,000 of our Series 1 Preferred Shares to an accredited investor in a private placement at a purchase price of $1,000,000 per Series 1 Preferred Share. Each Series 1 Preferred Share has a stated value of $1,000,000. The Series 1 Preferred Shares do not have voting rights except to the extent required by applicable law and are not convertible into the Company’s common shares. Holders of the Series 1 Preferred Shares will not be entitled to dividends but, in lieu thereof, will receive Net Sales Payments until such time as the holders have received total Net Sales Payments equal to 9 times the aggregate stated value of the outstanding Series 1 Preferred Shares. We will have the right to redeem the outstanding Series 1 Preferred Shares at any time at a redemption price equal to 9 times the aggregate stated value of the Series 1 Preferred Shares outstanding less the aggregate amount of the Net Sales Payments paid (the “Redemption Amount”). Upon any dissolution, liquidation or winding up, whether voluntary or involuntary, holders of Series 1 Preferred Shares will be entitled to a liquidation preference equal to the stated value of the Series 1 Preferred Shares less the Net Sales Payments paid on the Series 1 Preferred Shares. In the event of a fundamental transaction (defined in the Series 1 Preferred Shares to include an amalgamation, merger or other business combination transaction involving our company in which our shareholders do not have the right to cast more than 50% of the votes that may be cast for the election of directors, or a sale, lease or other disposition of the properties and/or assets of our company as an entirety or substantially as an entirety to a third party), the holders of the Series 1 Preferred Shares will be entitled to receive consideration for their Series 1 Preferred Shares equal to a multiple of the stated value of the Series 1 Preferred Shares ranging from 5.0 to 9.0 depending on the timing of the fundamental transaction, subject to a cap equal to the Redemption Amount.

In December 2018, we entered into an at-the-market equity offering sales agreement with Cantor Fitzgerald & Co. under which we may sell pursuant to the universal shelf registration statement common shares in the United States only, from time to time, for up to $50.0 million and was $765,853 asamended on March 25, 2019 to $10.0 million in aggregate sales proceeds in "at the market" transactions. No sales of common shares were made under the sales agreement in the second and third quarters, and the program was inactive at September 30, 2018. This was primarily due to cash and cash equivalents of $526,817 and prepaid expenses and deposits of $1,481,673, partially offset by accounts payables and accrued liabilities of $1,280,379.2019.

 

On October 17, 2017 we entered into a five-year $5,000,000 unsecured working capital facility with Equidebt LLC, one of our shareholders (the “Equidebt Facility”). Amounts borrowed under the Equidebt Facility bear interest at a rate of 14% per annum payable at maturity. All amounts borrowed under the Equidebt Facility become due and payable on October 17, 2022. We can make two borrowings per month under the Equidebt Facility, each of which must be for a minimum of $250,000. The Equidebt Facility is unsecured; however Gerald A. Solensky Jr., our Chairman of the Board, President and Chief Executive Officer, has personally guaranteed our obligations under the Equidebt Facility. As of September 30, 2018 we have not borrowed against this facility.

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On May 15, 2018, we announced a private offering of up to $10,000,000 of our common shares at a price of $2.15 per share (the “Private Placement”) and we issued 255,815 common shares for gross proceeds of $550,000. On June 28, 2018, we issued an additional 1,605,812 common shares for gross proceeds of $3,452,496 pursuant to the Private Placement. On July 28, 2018, the Private Placement of common shares expired with2019, no additional sales. In aggregate, we sold a total of 1,861,627 common shares at a price of $2.15 per share for total gross proceeds of approximately $4,002,496. These common shares may not be offered or sold in the United States unless they are registered under the Securities Act, or an exemption from the registration requirements of the Securities Act is available. We recorded $23,806 of share issuance costs as an offset to capital stock.

We believe that our existing cash and available borrowingsamounts were outstanding under the Equidebt Facility will be sufficient to fund our operations through the next twelve months. Our ability to continue as a going concern is ultimately dependent upon our ability to achieve sustainable positive cash flow from operations. However, we do not expect to generate revenue from the sale of our product candidates for the foreseeable future. To the extent that we do not generate sufficient cash flow from our operations, we intend to finance our working capital requirements through equity and/or debt financings, development agreements or marketing license agreements, the collection of revenues resulting from future commercialization activities and/or new strategic partnership agreements. There can be no assurance that we will be able to obtain any such capital on terms or in amounts sufficient to meet our needs or at all. The availability of equity or debt financing will be affected by, among other things, the results of our research and development activities, our ability to obtain regulatory approvals, market acceptance of any products for which we receive marketing approval, conditions in the capital markets generally and in the veterinary products industry, strategic alliance agreements and other relevant commercial considerations.Facility.

 

If we raise additional funds by issuing equity securities, our existing security holders will likely experience dilution, and the incurring of indebtedness would result in increased debt service obligations and could require us to agree to operating and financial covenants that could restrict operations. In the event that we are unable to obtain sufficient capital to meet our working capital requirements, we may be required to change or curtail current or planned operations in order to conserve cash until such time, if ever, that sufficient proceeds from operations are generated. In such an event, we may not be able to take advantage of business opportunities, and may have to terminate or delay safety and efficacy studies, curtail our product development programs, or sell or assign rights to our product candidates, products and technologies.

Based on the closing price of our common shares on September 30, 2018, the market price of our common shares exceeded the exercise price of our outstanding stock options. To the extent that some or all of such stock options are exercised, we would receive the proceeds of such exercises which would provide additional capital for our company. However no assurance can be given that any of such stock options will be exercised or as to the proceeds and timing of any exercises that do occur. The willingness of option holders to exercise their options depends on a number of factors, including, without limitation: the future market price of our common shares; the availability of capital to fund the payment of the exercise price of such options, the tax consequences of any such exercises and the ability of such option holders to resell some or all of the common shares received upon such exercises.


Our future capital requirements depend on many factors, including, but not limited to:

 

the scope, progress, results and costs of researching and developing our current or future product candidates;

 

the timing of, and the costs involved in, obtaining regulatory approvals for any of our current or future product candidates;

 

the number and characteristics of the product candidates we pursue;

 

the cost of manufacturing our current and future product candidates and any products we successfully commercialize;

 

the cost of commercialization activities if any of our current or future product candidates are approved for sale, including marketing, sales, service, customer support and distribution costs;

 

the expenses needed to attract and retain skilled personnel;

 

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the costs associated with being a public company;

 

our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such agreements; and

 

the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing possible patent claims, including litigation costs and the outcome of any such litigation.

 

Off Balance Sheet Arrangements

 

Since inception, we have not engaged in the use of any off-balance sheet arrangements, such as structured finance entities, special purpose entities or variable interest entities.

 

RecentContingencies and Legal Proceedings

On November 1, 2019, Heska Corporation (“Heska”) filed a complaint for damages and injunctive relief (the “Complaint”) in the United States District Court for the Middle District of North Carolina, Case 1:19-cv-01108-LCB-JLW, against Qorvo US, Inc. (“Qorvo US”), Qorvo Biotechnologies, LLC (“Qorvo Biotech” and, together with Qorvo US, “Qorvo”) and the Company (collectively with Qorvo, the “Defendants”). The Complaint alleges, among other things, that the Defendants improperly obtained Heska’s trade secrets and confidential information and/or conspired to use improper means to misappropriate Heska’s trade secrets related to an instrument and related consumable products for performing immunoassay analysis of biomarkers and other substances. The Complaint seeks compensatory and exemplary damages, as well as preliminary and permanent injunctive relief to prevent the Defendants from commercializing the Company’s TRUFORMATM diagnostic instrument. For the reasons set forth below, the Company believes that the allegations in the Complaint have no merit and will not have a material adverse effect on the Company’s business, results of operations or financial condition, and the Company reaffirms its intention to commence the commercialization of its TRUFORMATM platform in the first quarter of 2020.

Under the terms of the Development and Supply Agreement, dated November 26, 2018, by and between Qorvo Biotech and the Company (the “Qorvo Agreement”), Qorvo Biotech agreed to indemnify the Company and certain related parties against claims alleging infringement or misappropriation of third-party intellectual property rights, subject to certain limitations and exceptions. Qorvo Biotech has notified the Company that Qorvo Biotech has assumed the defense of the Complaint and will indemnify the Company for losses arising from the Complaint in accordance with the terms of the Qorvo Agreement. Qorvo Biotech has further advised the Company that it intends to mount a vigorous defense to the claims in the Complaint, and that it believes the allegations contained in the Complaint are without merit for many reasons, including without limitation, the following:

The Complaint fails to identify any Heska proprietary trade secret technology that is contained in the TRUFORMATM platform, and Qorvo and Zomedica are aware of no such technology; and

Two United States courts have previously considered many of the same allegations contained in the Complaint, and after extensive motion practice, refused to grant Heska’s requests to take discovery from Qorvo relating to Heska’s claims. During those proceedings, Heska did not demonstrate that Qorvo was using any Heska proprietary trade secret technology.

Recently Adopted Accounting Pronouncements

 

In February 2016, the FASB issued new guidance, ASU No. 2016-02, Leases (Topic 842). The main difference between current U.S. GAAPnew standard establishes a right-of-use model (“ROU”) that requires a lessee to recognize a ROU asset and the new guidance is the recognition of lease liabilities basedliability on the present valuebalance sheet for all leases with a term longer than 12 months. Leases will be classified as finance or operating, with classification affecting the pattern and classification of remaining lease payments and corresponding lease assets for operating leases under current U.S. GAAP with limited exception.expense recognition in the income statement. Additional qualitative and quantitative disclosures are also required by the new guidance. Topic 842 is effective for annual reporting periods (including interim reporting periods) beginning after December 15, 2018. Early adoption is permitted. We are

A modified retrospective transition approach is required, applying the new standard to all leases existing at the date of initial application. The Company adopted the new standard with an initial application date of January 1, 2019 and used the effective date as its date of initial application. Consequently, financial information was not updated, and the disclosures required under the new standard were not provided for dates and periods before January 1, 2019.

The new standard provides a number of optional practical expedients in transition. The Company has elected the process‘package of evaluatingpractical expedients’, which permits the amendmentsCompany not to reassess under the new standard prior conclusions about lease identification, lease classification and initial direct costs. The Company has not elected the use-of-hindsight or the practical expedient pertaining to land easements; the latter not being applicable to the Company.

On August 29, 2018, the FASB issued ASU 2018-15, which amends ASC 350-40 to address a customer’s accounting for implementation costs incurred in a cloud computing arrangement (CCA) that is a service contract. ASU 2018-15 aligns the accounting for costs incurred to implement a CCA that is a service arrangement with the guidance on capitalizing costs associated with developing or obtaining internal-use software. Specifically, the ASU amends ASC 350 to include in its scope implementation costs of a CCA that is a service contract and clarifies that a customer should apply ASC 350-40 to determine if they havewhich implementation costs should be capitalized in a material impact on our financial position, results of operations, cash flows or disclosures.CCA that is considered a service contract. The amendments in this update are effective for public business entities for fiscal years beginning after December 15, 2019. Early adoption is permitted.

The Company has chosen to adopt this guidance during the three months ended September 30, 2019.


Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

Not applicable.

 

Item 4. Controls and Procedures.

 

Disclosure Controls and Procedures

 

Evaluation of Our Disclosure Controls

 

We maintain disclosure controls and procedures that are designed to provide reasonable assurance that material information required to be disclosed in our periodic reports filed under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and to provide reasonable assurance that such information is accumulated and communicated to our management, our chief executive officer and our chief financial officer, to allow timely decisions regarding required disclosure. We carried out an evaluation, under the supervision and with the participation of our management, including our principal executive and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rule 13(a)-15(e) under the Exchange Act. Based on this evaluation, our principal executive officer and principal financial officer concluded that, as of SeptemberJune 30, 2018,2019, our disclosure controls and procedures were effective.

 

Management’s Report on Internal Control Over Financial Reporting

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on criteria established in the framework in “Internal Control — Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation, our management concluded that our internal control over financial reporting was effective as of SeptemberJune 30, 2018.

2019.

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PART II — OTHER INFORMATION

 

Item 1. Legal Proceedings.

 

WeOn November 1, 2019, Heska Corporation (“Heska”) filed a complaint for damages and injunctive relief (the “Complaint”) in the United States District Court for the Middle District of North Carolina, Case 1:19-cv-01108-LCB-JLW, against Qorvo US, Inc. (“Qorvo US”), Qorvo Biotechnologies, LLC (“Qorvo Biotech” and, together with Qorvo US, “Qorvo”) and the Company (collectively with Qorvo, the “Defendants”). The Complaint alleges, among other things, that the Defendants improperly obtained Heska’s trade secrets and confidential information and/or conspired to use improper means to misappropriate Heska’s trade secrets related to an instrument and related consumable products for performing immunoassay analysis of biomarkers and other substances. The Complaint seeks compensatory and exemplary damages, as well as preliminary and permanent injunctive relief to prevent the Defendants from commercializing the Company’s TRUFORMATM diagnostic instrument. For the reasons set forth below, the Company believes that the allegations in the Complaint have no merit and will not have a material adverse effect on the Company’s business, results of operations or financial condition, and the Company reaffirms its intention to commence the commercialization of its TRUFORMATM platform in the first quarter of 2020.

Under the terms of the Development and Supply Agreement, dated November 26, 2018, by and between Qorvo Biotech and the Company (the “Qorvo Agreement”), Qorvo Biotech agreed to indemnify the Company and certain related parties against claims alleging infringement or misappropriation of third-party intellectual property rights, subject to certain limitations and exceptions. Qorvo Biotech has notified the Company that Qorvo Biotech has assumed the defense of the Complaint and will indemnify the Company for losses arising from the Complaint in accordance with the terms of the Qorvo Agreement. Qorvo Biotech has further advised the Company that it intends to mount a vigorous defense to the claims in the Complaint, and that it believes the allegations contained in the Complaint are without merit for many reasons, including without limitation, the following:

The Complaint fails to identify any Heska proprietary trade secret technology that is contained in the TRUFORMATM platform, and Qorvo and Zomedica are aware of no such technology; and

Two United States courts have previously considered many of the same allegations contained in the Complaint, and after extensive motion practice, refused to grant Heska’s requests to take discovery from Qorvo relating to Heska’s claims. During those proceedings, Heska did not currently a party todemonstrate that Qorvo was using any material legal proceedings.

Heska proprietary trade secret technology.

 

Item 1A.Risk Factors.

 

RISK FACTORS

 

Risks Related to Our Business

 

We have a limited operating history, are not profitable and may never become profitable.

 

We are a development stage veterinary diagnostic and pharmaceutical company creating products for companion animals (canine, feline and equine) by focusing on the unmet needs of clinical veterinarians. Since the commencement of our business in May 2015, our operations have been primarily limited to the identification of product candidates and research and development of our diagnostic and drug product candidates, ZM-020, a Raman spectroscopy-based point-of-care diagnostic platform, ZM-017, a non-invasive diagnostic assay or blood test for the detection of certain cancers in canines, ZM-007 and ZM-012, an anti-diarrheal oral suspension and pill form respectively that is intended for use in dogs, ZM-006, a transdermal gel treatment for hyperthyroidism, a metabolic disorder, which is intended for use in cats and ZM-011, a transdermal gel treatment for behavioral disorders intended for use in cats. As a result, we have limited historical operations upon which to evaluate our business and prospects and we have not yet demonstrated an ability to obtain approval for any of our product candidates or successfully overcome the risks and uncertainties frequently encountered by companies in emerging fields such as the companion animal pharmaceuticals and health care solutions industries.

We also have not generated any revenue to date, and we expect to continue to incur significant research and development costs and other expenses. Our net loss and comprehensive loss for the three months ended September 30, 20182019 and September 30, 20172018 was $1,910,278$3,338,549 and $2,080,682,$1,910,278, respectively, for the nine months ended September 30, 20182019 and September 30, 20172018 was $8,226,005$17,419,886 and $5,501,788,$8,226,005, respectively, and for the years ended December 31, 20172018 and December 31, 20162017 was $8,065,072$16,647,687 and $5,740,492,$8,065,075, respectively. Our accumulated deficit as of September 30, 20182019 was $23,852,105.$49,693,673. As of September 30, 2018,2019, we had total shareholders'shareholders’ equity of $2,910,267.$4,540,629. We expect to continue to incur losses for the foreseeable future, which will increase significantly from historical levels as we expand our product development activities (including conducting required clinical studies and trials), seek necessary approvals for our product candidates, and begin commercialization activities. Even if we succeed in developing and broadly commercializing one or more of our product candidates, we expect to continue to incur losses for the foreseeable future, and we may never become profitable. If we fail to achieve or maintain profitability, then we may be unable to continue our operations at planned levels and be forced to reduce or cease operations.

 

We will need to raise additional capital to achieve our goals.

 

We do not have any products approved for sale. Although we believe that we do not require pre-market approval from the U.S. Food and Drug Administration’s Center for Veterinary Medicine, or the FDA-CVM, to market and sell ZM-020, our Raman spectroscopy-based point-of-care diagnosticbiosensor platform TRUFORMATM, our point-of-care pathogen detection platform (ZM-020), or ZM-017, the circulating tumor cell, or CTC, diagnostic assay and lymphoma assay (ZM-017 and ZM-022, respectively) that we are developing, we do not expect to commence marketing of these solutions until the secondfirst half of 2018.2020.

 

Until, and unless, we receive approval from the FDA-CVM for our drug product candidates, we cannot market or sell our drug products in the United States and will have no material drug product revenue. Our lead drug product candidates ZM-007, ZM-012, ZM-006 and ZM-011 are in the formulation, optimization and/or pilot study stage, and we have not yet begun pivotal trials. We anticipate that each of our drug product candidates will require from three toapproximately five years of development at a cost of approximately $3 million to $5$6 million per drug product candidate before we expect to be able to apply for marketing approval in the United States. In addition, certain assays that we may choose to pursue for use in our diagnostic platforms may require pre-market regulatory approval.

 

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We are also seeking to identify potential complementary opportunities in the veterinary diagnostics and therapeutics sectors. We will continue to expend substantial resources for the foreseeable future to develop our existing product candidates and any other product candidates that we may develop or acquire. These expenditures will include: costs of identifying additional potentialdeveloping and validating our diagnostic product candidates;candidates and related assays and consumables; costs associated with drug formulation; costs associated with conducting pilot and pivotal trials and clinical studies; costs associated with completing other research and development activities; costs of identifying additional potential product candidates; costs associated with payments to technology licensors and maintaining other intellectual property; costs of obtaining regulatory approvals; costs associated with securing contract manufacturers to meet our commercial manufacturing and supply capabilities; and costs associated with marketing and selling anyour products. In addition, under our existing development agreements, we are required make significant cash milestone payments to our development partners and to pay certain development costs. We do not control the timing of our products approved for sale.these payments. We also may incur unanticipated costs. Because the outcome of our development activities and commercialization efforts is inherently uncertain, the actual amounts necessary to successfully complete the development and commercialization of our existing or future product candidates may be greater or less than we anticipate.


 

As a result, we will need to obtain additional capital to fund the development of our business. Except for our $5,000,000 unsecured working capital loan we have no existing agreements or arrangements with respect to any financings, and any such financings may result in dilution to our shareholders, the imposition of debt covenants and repayment obligations or other restrictions that may adversely affect our business or the value of our common shares.

 

Our future capital requirements depend on many factors, including, but not limited to:

 

the scope, progress, results and costs of researching and developing our existing or future diagnostics and product candidates;
·the scope, progress, results and costs of researching and developing our existing or future diagnostics and product candidates;

 

the timing of, and the costs involved in, obtaining regulatory approvals for any of our existing or future diagnostics or product candidates;
·the extent to which any of our future diagnostic assays may be subject to USDA-CVB pre-market regulation;

 

the number and characteristics of the diagnostics and/or product candidates we pursue;
·the timing of, and the costs involved in, obtaining regulatory approvals for any of our existing or future diagnostics or product candidates;

 

the cost of contract manufacturers to manufacture our existing and future diagnostics and product candidates and any products we successfully commercialize;
·the number and characteristics of the diagnostics and/or product candidates we pursue;

 

the cost of commercialization activities if any of our existing or future diagnostics and product candidates are approved for sale, including marketing, sales and distribution costs;
·the cost of contract manufacturers to manufacture our existing and future diagnostics and product candidates and any products we successfully commercialize;

 

the expenses needed to attract and retain skilled personnel;
·the cost of commercialization activities if any of our existing or future diagnostics and product candidates are approved for sale, including marketing, sales and distribution costs;

 

the costs associated with being a public company;
·the expenses needed to attract and retain skilled personnel;

 

our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such agreements; and
·the costs associated with being a public company;

 

the costs involved in preparing and filing patent applications, maintaining any successfully obtained patents and protecting and enforcing any such patents.
·our ability to establish and maintain strategic partnerships, licensing or other arrangements and the financial terms of such agreements; and

·the costs involved in preparing and filing patent applications, maintaining any successfully obtained patents and protecting and enforcing any such patents.

 

Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds are not available to us on a timely basis, we may be required to delay, limit, reduce or terminate one or more of our product development programs or any future commercialization efforts.

 

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We are substantially dependent on the successIn March of 2019, we completed an underwritten public offering of our lead product candidates,common shares for $3,000,000 and cannot be certain that anyin June of them2019, we completed a private offering of our Series 1 Preferred Shares for $12,000,000, however, we will be approved for marketing,need to the extent applicable, or successfully commercialized.

We have no products approved for sale in any jurisdiction and are focused primarily onobtain additional capital to fund the development of our lead diagnostic and drug product candidates, ZM-020, ZM-017, ZM-007, ZM-012, ZM-006 and ZM-011. Accordingly, our near-term prospects, including our ability to generate material product revenue, or enter into potential strategic transactions, will depend heavily on the successful development and commercialization of one or more of our lead candidates, which in turn will depend on a number of factors, including the following:

the successful completion of clinical validation of our diagnostic product candidates, which may take significantly longer than we anticipate and will depend, in part, upon the satisfactory performance of third-party contractors;
the successful completion of pilot testing and pivotal efficacy and safety trials of one or more of our drug product candidates, which may take significantly longer than we anticipate and will depend, in part, upon the satisfactory performance of third-party contractors;

our ability to demonstrate to the satisfaction of the FDA-CVM or the USDA Center for Veterinary Biologics, or USDA-CVB, as applicable, the safety and efficacy of our drug product candidates and to obtain regulatory approvals;

the ability of our third-party contract manufacturers to manufacture supplies of any of our product candidates and to develop, validate and maintain viable commercial manufacturing processes that are compliant with Good Manufacturing Practices or GMP;

our ability to successfully market any product candidate for which marketing approval is received, whether alone or in collaboration with others;

the availability, perceived advantages, relative cost, relative safety and relative efficacy of our product candidates compared to alternative and competing treatments;

the acceptance of our product candidates as safe and effective by veterinarians, pet owners and the animal health community;

our ability to achieve and maintain compliance with all regulatory requirements applicable to our business; and

our ability to obtain and enforce our intellectual property rights and obtain marketing exclusivity for our product candidates, and avoid or prevail in any third-party patent interference, patent infringement claims or administrative patent proceedings initiated by third parties or the United States Patent and Trademark Office (“USPTO”).

Many of these factors are beyond our control. Accordingly, we cannot assure you that we will be successful in developing or commercializing any of our product candidates. If we are unsuccessful or are significantly delayed in developing and commercializing ZM-020, ZM-017, ZM-007, ZM-012, ZM-006 or ZM-011 or any of our other product candidates, our business and prospects will be materially adversely affected and you may lose all or a portion of your investment. business.

 

Risks Related to Our product candidates will face significant competition and may be unable to compete effectively.

The development and commercialization of veterinary diagnostics and pharmaceuticals is highly competitive and our success depends on our ability to compete effectively with other products in the market.

There are a number of competitors in the diagnostic market that have substantially greater financial and operational resources and established marketing, sales and service organizations. We expect to compete primarily with commercial clinical laboratories, hospitals’ clinical laboratories and other veterinary diagnostic equipment manufacturers. Our principal competitors in the veterinary diagnostic market are Idexx Laboratories, Inc., Antech Diagnostics, a unit of VCA Inc., Abaxis, Inc., Heska Corporation and Zoetis Inc. We must develop our distribution channels and build our direct sales force in order to compete effectively in these markets. If we are unable to effectively manage our distribution channels in our highly competitive industry, we may fail to retain customers or obtain new customers and our business will suffer.

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If our drug product candidates are approved, we expect to compete with large animal health companies including Merck Animal Health, the animal health division of Merck & Co., Inc.; Elanco, the animal health division of Eli Lilly and Company; Bayer Animal Health, the animal health division of Bayer AG; Novartis Animal Health, the animal health division of Novartis AG; Boehringer Ingelheim Animal Health, the animal health division of Boehringer Ingelheim GmbH; and Zoetis, Inc., as well as European companies such as Virbac S.A., Vetoquinol S.A. and Dechra Pharmaceuticals PLC We are also aware of several smaller early stage companies that are developing products for use in the pet therapeutics market, including Kindred Biosciences, Inc., Aratana Therapeutics, Inc., Parnell Pharmaceuticals Holdings Ltd. and Jaguar Animal Health, Inc. We also expect to compete with academic institutions, governmental agencies and private organizations that are conducting research in the field of animal health medicines.

We target drug product candidates for which the API, while having been approved for use in human drugs, has not been previously approved for use in animals. If we are the first to gain approval for the use of such API in animals, our drug products will benefit from between three and seven years of marketing exclusivity in the United States for the approved indication. We also plan to differentiate our products, where possible, with alternative drug delivery systems that are more conducive to dosing for the target companion animal species, but we cannot assure you that we will be able to prevent our competitors from developing substantially similar products and bringing those products to market earlier than we are able to.

Our drug product candidates will face competition from various products approved for use in humans that are used off-label in animals, and all of our products will face potential competition from new products in development. These and other potential competing products may benefit from greater brand recognition and brand loyalty than our drug product candidates may achieve.

Many of our competitors and potential competitors have substantially more financial, technical and human resources than we do. Many also have far more experience than we have in the development, manufacture, regulation and worldwide commercialization of animal health medicines, including pet therapeutics. We also expect to compete with academic institutions, governmental agencies and private organizations that are conducting research in the fields of animal diagnostics and animal health. If such competing products are commercialized prior to our product candidates, or if our intellectual property protection and efforts to obtain regulatory exclusivity fail to provide us with exclusive marketing rights for some of our therapeutic products, we may be unable to compete effectively in the markets in which we participate. Contractual agreements between clinics and from competitors may limit practices’ ability to use other tests and technologies due to predetermined minimums in those agreements.

Development of product candidates for use in companion animal health is an inherently expensive, time-consuming and uncertain, and any delay or discontinuance of validation or pivotal studies for our current or future product candidates would significantly harm our business and prospects.

Development of product candidates for use in companion animals is an inherently lengthy, expensive and uncertain process, and there is no assurance that our development activities will be successful. We do not know whether the validation studies of ZM-017 or ZM-020, or the pivotal studies of ZM-007, ZM-012, ZM-006 or ZM-011, or of any of our other product candidates, will begin or conclude on time, and they may be delayed or discontinued for a variety of reasons, including if we are unable to:

address any safety concerns that arise during the course of the studies;

complete the studies due to deviations from the study protocols,  the occurrence of adverse events or, in the case of our validation studies, sensitivity and selectivity results that vary from our expectations;

add new study sites;

address any conflicts with new or existing laws or regulations; or

reach agreement on acceptable terms with study sites, which can be subject to extensive negotiation and may vary significantly among different sites.

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Any delays in completing our development efforts will increase our costs, delay our product candidate development and any regulatory approval process and jeopardize our ability to commence product sales and generate revenue. Any of these occurrences may significantly harm our business, financial condition and prospects. In addition, factors that may cause a delay in the commencement or completion of our development efforts may also ultimately lead to the denial of regulatory approval of our product candidates which, as described above, would materially, adversely impact our business and prospects.Securities

 

We will rely on third partiesbe obligated to conduct certain portionspay a significant portion of our development activities. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, wenet sales to the holders of our Series 1 Preferred Shares. This payment obligation will materially and adversely affect our liquidity and capital resources, may be unableadversely impact our ability to obtain regulatory approval for or commercializeraise additional capital, and could adversely affect the trading price of our product candidates.common shares.

 

We have used contract manufacturing organizations (“CMOs”) and contract research organizations (“CROs”)are obligated to conduct our manufacturing and research and development activities. We expectmake annual payments to continue to do so, including with respect to our manufacturing, clinical validation, pilot studies and pivotal trials of ZM-020, ZM-017, ZM-007, ZM-012, ZM-006 and ZM-011. These CMOs and CROs are not our employees, and except for contractual duties and obligations, we have limited ability to control the amount or timing of resources that they devote to our programs or manage the risks associated with their activities on our behalf. We are responsible to regulatory authorities for ensuring that eachholders of our product candidates is manufactured using good manufacturing practicesSeries 1 Preferred Shares in an amount equal to nine percent of the net sales (as defined in the Series 1 Preferred Shares), if any, of our company and studies are conductedour affiliates (the “Net Sales Payments”) until such time as the holders have received total Net Sales Payments equal to nine times the aggregate stated value of the outstanding Series 1 Preferred Shares. Such payments will materially and adversely affect our liquidity and capital resources which could result in accordance with the development plans and trial protocols, and any failure bya shortage of capital necessary to fund our CMOs and CROsoperations or to do sotake advantage of business opportunities as they arise. Our obligation to make these payments may make it more difficult for us to raise additional capital on terms acceptable to us, or at all. This payment obligation also may adversely affect our ability to obtain regulatory approvals, subject us to penalties, or harm our credibility with regulators. The FDA-CVM also requires us and our CMOs and CROs to comply with regulations and standards, commonly referred to as good manufacturing practices, or GMPs, good clinical practices, or GCPs, and good laboratory practices, or GLPs, collectively called GXPs, for conducting, monitoring, recording and reporting the resultsinvestor perceptions of our manufacturing and studiescompany which could adversely affect the trading price of our common shares.


In the event of a sale of our company, holders of our Series 1 Preferred Shares will be entitled to ensure thata substantial premium on the data and results are scientifically credible and accurate.

Our agreements with our CMOs and CROs may allow termination bypurchase price they paid for their Series 1 Preferred Shares, which will reduce the CMOs and CROs in certain circumstances with little or no advance notice to us. These agreements generally will require our CMOs and CROs to reasonably cooperate with us at our expense for an orderly winding down of the CMOs’ and CROs’ services under the agreements. If the CMOs and CROs conducting our manufacturing and studies do not comply with their contractual duties or obligations to us, or if they experience work stoppages, do not meet expected deadlines, terminate their agreements with us or needsale proceeds to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our development protocols or GXPs or for any other reason, we may need to secure new arrangements with alternative CMOs and CROs, which could be difficult and costly. In such event, our studies also may need to be extended, delayed or terminated as a result, or may need to be repeated. If any of the foregoing were to occur, regulatory approval and commercializationreceived by holders of our product candidates may be delayed and we may be required to expend substantial additional resources.

The failure of any CMO and CRO to perform adequately or the termination of any arrangements with any of them may adversely affect our business.

Risks Related to Government Regulation

Various government regulations could limit or delay our ability to develop and commercialize our products or otherwise negatively impact our business.common shares.

 

In the U.S.,event that our company is the manufacture and salesubject of certain diagnostic products are regulated by agencies such asa “fundamental transaction” (defined in the USDA, the FDASeries 1 Preferred Shares to include an amalgamation, merger or the EPA. Whileother business combination transaction involving our point-of-care Raman spectroscopy-based diagnostic solution andcompany in which our diagnostic test for canine cancershareholders do not require approval byhave the USDA priorright to cast more than 50% of the votes that may be cast for the election of directors, or a sale, lease or other disposition of the properties and/or assets of our company as an entirety or substantially as an entirety to a third party) the holders of the Series 1 Preferred Shares will have the right, in preference to the holders of our common shares, to receive a portion of the aggregate consideration paid in the U.S., these diagnostic solutionsfundamental transaction that will represent a substantial premium on the purchase price they paid for their Series 1 Preferred Shares. Such premium will reduce the proceeds of any such fundamental transaction that would be subject to post-marketing oversightreceived by holders of our common shares.

In the FDA-CVM. In addition, delays in obtaining regulatory approvals for new productsevent of the liquidation, dissolution or product upgrades couldwinding up of our company, holders of the Series 1 Preferred Shares will have a negative impact onliquidation preference over holders of our growthcommon shares and profitability.if the net assets of our company available for distribution to holders of our equity securities is not sufficient to pay this liquidation preference in full, holders of our common shares would receive no liquidating distribution in respect of their common shares.

 

The manufacture and saleIn the event of the liquidation, dissolution or winding up of our products, as well ascompany, holders of the Series 1 Preferred Shares will have a liquidation preference equal to the stated value of the Series 1 Preferred Shares less the Net Sales Payments paid on the Series 1 Preferred Shares before holders of our research and development processes, are subjectcommon shares would be entitled to similar and potentially more stringent lawsany proceeds of such liquidation, dissolution or winding up. If the net assets of our company available for distribution to holders of our equity securities is not sufficient to pay this liquidation preference in foreign countries.full, holders of our common shares would receive no liquidating distribution in respect of their common shares.

 

We are also subject to a variety of federal, state, local and international laws and regulations that govern, among other things, the importation and exportation of products; our business practices in the U.S. and abroad, such as anti-corruption and anti-competition laws; and immigration and travel restrictions. These legal and regulatory requirements differ among jurisdictions around the world and are rapidly changing and increasingly complex. The costs associated with compliance with these legal and regulatory requirements are significant and likely to increase in the future.

Any failure to comply with applicable legal and regulatory requirements could result in fines, penalties and sanctions; product recalls; suspensions or discontinuations of, or limitations or restrictions on, our ability to design, manufacture, market, import, export or sell our products; and damage to our reputation.

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Risks Related to Intellectual Property

 

Our diagnostic assay technologies depend on certain technologies that are licensedability to us. We do not control these technologies and any loss ofobtain intellectual property protection for our rights to them could prevent us from marketing our diagnostic product candidates.candidates is limited.

 

Our Raman spectroscopy-based point-of-care diagnostic product istechnologies are dependent on a license from Seraph Biosciences, Inc., whileintellectual property developed by our canine cancer diagnostic assay technology is dependent on a license from Celsee, Inc.strategic partners and licensed to us. We do not own the intellectual property rights that underlie these technology licenses. Our rights to use the technology we license are subject to the negotiation of, continuation of and compliance with the terms of our licenses. WeHowever, we have filed three U.S. patent applications and two Patent Cooperation Treaty (PCT) applications for U.S. and international protection of our diagnostic tests. These applications cover tests developed for our ZM-017, ZM-022 and ZM-020 technology platforms. Even if such patents are issued, we do not control the prosecution, maintenance or filingexpect that all of the patents will provide significant protection for our intellectual property.

If we are unable to obtain trademark registrations for our products our business could be adversely affected.

We have pending trademark applications for our company name and composite marks comprised of our company name, logo and/or slogan in the U.S., Canada, European Union, the United Kingdom, and Mexico. In addition, we have pending trademark applications for our “Voice of the Vet” mark in the U.S. and Canada. We have secured two registrations in the European Union for our company name, company name and logo, and for the mark “Voice of the Vet powered by Zomedica” (and Design). We also have secured registrations in Brazil for our company name and logo. While we cannot make assurances that any pending trademark applications will mature to registration, most of these applications are now poised to mature to registration.

We have also filed for protection of several product names in the U.S., Canada and European Union. Currently, no significant hurdles have been encountered in the registration process. Moreover, any name we propose to use with our product candidates in the United States must be approved by the FDA-CVM or the USDA-CVB regardless of whether we have registered it, or applied to register it, as a trademark. The FDA-CVM typically conducts a review of proposed product names, including an evaluation of potential for confusion with other product names. If the FDA-CVM or the USDA-CVB object to any of our proposed proprietary product names, we may be required to expend significant additional resources in an effort to identify a suitable substitute name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA-CVM and the USDA-CVB.


In most jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our trademark applications/registrations, and our trademark applications/registrations may not survive such proceedings. Finally, we may need to enforce our trademark rights against third parties and expend significant additional resources to enforce such rights against infringements.

Our business depends on our ability to acquire rights to use intellectual property licenseddeveloped by third parties and to avoid infringing the proprietary rights of third parties. We may not be able to obtain such rights on terms acceptable to us, or the enforcementif at all. We may be subject to claims of thesethird parties alleging infringement of their intellectual property rights. If we are sued for infringing third party intellectual property rights, againstsuch litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our product candidates or increase the cost of such development.

Our commercial success depends on our ability to develop, manufacture, market and sell our product candidates and use the proprietary technologies we have developed or licensed for use in our product candidates without infringing the proprietary rights of third parties. The patentsWe may not be able to obtain rights to use technology developed by third parties on terms acceptable to us, if at all.

We cannot assure you that marketing and patent applications underlyingselling our licenses wereproduct candidates and using such technologies will not written by us or our attorneys, and we do not have control over the drafting and prosecution of such rights. Seraph and Celsee might not have given the same attention to the drafting and prosecution of patents and patent applications as we would have if we had been the owners ofinfringe the intellectual property rights and had control overof third parties. We may be exposed to, or threatened with, future litigation by third parties alleging that our product candidates or proprietary technologies infringe such drafting and prosecution. We cannot be certain that drafting and/or prosecution of the licensed patents and patent applications has been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents and otherthird parties’ intellectual property rights. This type of litigation can be costly and could adversely affect our operating results and divert the attention of managerial and technical personnel, even if it is ultimately determined that we have not infringed such third-party rights. Such litigation could prevent or delay us from developing or commercializing our product candidates or increase the cost of such development. There is a risk that a court could decide that we are infringing the third party’s intellectual property rights and could order us to stop the activities covered by such third-party rights. In addition, there is a risk that a court could order us to pay the other party significant damages for having violated the other party’s intellectual property rights. We may be forced to seek a license to use such intellectual property on terms that are not favorable to us.

Because we rely on certain third-party licensors and partners and will continue to do so in the future, if one of our licensors or partners is sued for infringing a third party’s intellectual property rights, our business, financial condition, operating results and prospects could suffer in the same manner as if we were sued directly, even if we are entitled to indemnification for such claims.

The occurrence of any of the foregoing could adversely affect our business, financial condition or operating results.

On November 1, 2019, Heska Corporation (“Heska”) filed a complaint for damages and injunctive relief (the “Complaint”) in the United States District Court for the Middle District of North Carolina, Case 1:19-cv-01108-LCB-JLW, against Qorvo US, Inc. (“Qorvo US”), Qorvo Biotechnologies, LLC (“Qorvo Biotech” and, together with Qorvo US, “Qorvo”) and the Company (collectively with Qorvo, the “Defendants”). The Complaint alleges, among other things, that the Defendants improperly obtained Heska’s trade secrets and confidential information and/or conspired to use improper means to misappropriate Heska’s trade secrets related to an instrument and related consumable products for performing immunoassay analysis of biomarkers and other substances. The Complaint seeks compensatory and exemplary damages, as well as preliminary and permanent injunctive relief to prevent the Defendants from commercializing the Company’s TRUFORMATM diagnostic instrument.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

Not applicable.

Item 3. Defaults Upon Senior Securities.

Not applicable.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

None.


Item 6. Exhibits.

 

The exhibits listed on the accompanying index to exhibits immediately preceding the exhibits are filed as part of, or hereby incorporated by reference into, this Quarterly Report.

 


 

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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.

 

  Zomedica Pharmaceuticals Corp.
   
  By: /s/ Gerald Solensky, Jr.
  Name: Gerald Solensky, Jr.
  Title: Chief Executive Officer
     
     
  By: /s/ Shameze Rampertab
  Name: Shameze Rampertab
  Title: Chief Financial Officer
     

 

 

 

 


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EXHIBIT INDEX

 

Exhibit

No.

 Description
   
3.1 Articles of Amalgamation of Zomedica Pharmaceuticals Corp. (incorporated by reference to Exhibit 3.1 to the Company'sCompany’s Registration Statement on Form S-1 filed with the Commission on April 21,November 20, 2017 (File No. 333-217409)).
   
3.2 Amended and Restated By-Law No. 1 of Zomedica Pharmaceuticals Corp. (incorporated by reference to Exhibit 3.2 to the Company'sCompany’s Registration Statement on Form S-1 filed with the Commission on April 21,November 20, 2017 (File No. 333-217409)).
   
3.3 Certificate of Amendment and Registration of Restated Articles of Zomedica Pharmaceuticals Corp. (incorporated by reference to Exhibit 3.3 to the Company'sCompany’s Registration Statement on Form S-1 filed with the Commission on April 21,November 20, 2017 (File No. 333-217409)).
   
3.4 Certificate of Amalgamation of Zomedica Pharmaceuticals Corp. (incorporated by reference to Exhibit 3.4 to the Company'sCompany’s Registration Statement on Form S-1 filed with the Commission on April 21,November 20, 2017 (File No. 333-217409)).
   
10.253.5 FirstArticles of Amendment to Lease Agreement for 100 Phoenix Drive, Ann Arbor MI 48108the Articles of Incorporation of Zomedica Pharmaceuticals Corp.
   

10.2610.30+

 AddendumExecutive Employment Agreement between Zomedica Pharmaceuticals Corp. and Stephanie Morley (incorporated by reference to First AmendmentExhibit 10.30 to Lease Agreement 100 Phoenix Drive, Ann Arbor MI 48108the Company’s Current Report on Form 8-K filed on September 17, 2019).
   
31.1 Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
   
31.2 Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
   
32.1* Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350.
   
101.INS XBRL Instance Document.*
   
101.SCH XBRL Taxonomy Extension Schema Document.*
   
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document.*
   
101.DEF XBRL Taxonomy Extension Definition Linkbase Document.*
   
101.LAB XBRL Taxonomy Extension Label Linkbase Document.*
   
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document.*

 

* This certification is not deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, 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 or the Securities Exchange Act of 1934, except to the extent that the registrant specifically incorporates it by reference.

+ Indicates management contract or compensatory plan.

 

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