UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

QUARTERLY REPORT

 

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended JulyMarch 31, 20182019

 

Commission File No. 000-51128

 

POLARITYTE, INC.

(Exact name of registrant as specified in its charter)

 

DELAWARE 06-1529524
(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification No.)

 

1960 S 4250 W123 Wright Brothers Drive

Salt Lake City, UT 8410484116

(Address of principal executive offices)

 

Registrant’s Telephone Number, Including Area Code:(385) 237-2279(800) 560-3983

 

(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

 

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

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (232.4.05 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes [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 definition 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[  ]X]
Non-accelerated filer[  ] Smaller reporting company[X]
Emerging growth company[  ]   

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

 

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

 

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

Title of each classTrading SymbolName of each exchange on which registered
Common Stock, Par Value $0.001PTENasdaq Capital Market

As of September 12, 2018,May 3, 2019, there were 21,475,37024,722,212 shares of the Registrant’s common stock outstanding.

 

 

 

 

INDEX

 

 Page
PART I - FINANCIAL INFORMATION 
  
Item 1. Financial Statements: 
Condensed Consolidated Balance Sheets as of JulyMarch 31, 20182019 (unaudited) and OctoberDecember 31, 2017201834
Condensed Consolidated Statements of Operations for the three and nine months ended JulyMarch 31, 20182019 and 20172018 (unaudited)45
Condensed Consolidated StatementStatements of Changes inComprehensive Lossfor the three months ended March 31, 2019 and 2018 (unaudited)6
Condensed Consolidated Statements of Stockholders’ Equity for the ninethree months ended JulyMarch 31, 2019 and 2018 (unaudited)57
Condensed Consolidated Statements of Cash Flows for the ninethree months ended JulyMarch 31, 20182019 and 20172018 (unaudited)68
Notes to Condensed Consolidated Financial Statements (unaudited)79
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations2329
Item 3. Quantitative and Qualitative Disclosures about Market Risk2634
Item 4. Controls and Procedures2634
  
PART II - OTHER INFORMATION 
  
Item 1. Legal Proceedings27
Item 1A. Risk Factors28
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds30
Item 3. Defaults Upon Senior Securities30
Item 4. Mine Safety Disclosures30
Item 5. Other Information3035
Item 6. Exhibits3135
SIGNATURES3236

 

 

Forward-looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements. Risks and uncertainties are inherent in forward-looking statements. Furthermore, such statements may be based on assumptions that fail to materialize or prove incorrect. Consequently, our business development, operations, and results could differ materially from those expressed in forward-looking statements made in this Quarterly Report. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “would,” or the negative of these words or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:

the initiation, timing, progress, and results of our research and development programs;
  
the timing or success of commercialization of our products;
the pricing and reimbursement of our products;
the initiation, timing, progress, and results of our preclinical and clinical studies;
the scope of protection we can establish and maintain for intellectual property rights covering our product candidates and technology;
estimates of our expenses, future revenues, and capital requirements;
our need for, and ability to obtain, additional financing in the future;
our ability to comply with regulations applicable to the manufacture, marketing, sale and distribution of our products;
the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements;

our views about our prospects in ongoing litigation and SEC investigation;

developments relating to our competitors and industry; and
other risks and uncertainties, including those listed under Part I, Item 1A. Risk Factors of our Transition Report on Form 10-K filed with the Securities and Exchange Commission on March 18, 2019.

Given the known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by our forward-looking statements, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

3

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements:

 

PART I. FINANCIAL INFORMATIONPOLARITYTE, INC. AND SUBSIDIARIES

Item 1. Financial Statements

POLARITYTE, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

 

 July 31, 2018  October 31, 2017  March 31, 2019 December 31, 2018 
  (Unaudited)      (Unaudited)    
ASSETS             
             
Current assets:                
Cash and cash equivalents $84,827  $17,667  $34,948  $55,673 
Short-term investments  9,706   6,162 
Accounts receivable  329   -   788   712 
Inventory  255   -   309   336 
Prepaid expenses and other current assets  715   237   1,844   1,432 
Receivable from Zift  30   60 
Total current assets  86,156   17,964   47,595   64,315 
Non-current assets:                
Property and equipment, net  10,307   2,173   16,528   13,736 
Receivable from Zift, non-current  -   15 
Security deposits  139   - 
Operating lease right-of-use assets  4,960    
Intangible assets, net  873   924 
Goodwill  278   -   278   278 
Intangible assets, net  1,007   - 
Other assets  378   913 
Total non-current assets  11,731   2,188   23,017   15,851 
TOTAL ASSETS $97,887  $20,152  $70,612  $80,166 
                
LIABILITIES AND STOCKHOLDERS’ EQUITY                
                
Current liabilities:                
Accounts payable and accrued expenses $3,867  $1,939  $5,344  $6,508 
Contingent consideration  268   - 
Current portion of long-term notes payable  533   - 
Warrant liability and embedded derivative  -   13,502 
Other current liabilities  2,550   316 
Current portion of long-term note payable  529   529 
Deferred revenue  90   170 
Total current liabilities  4,668   15,441   8,513   7,523 
Long-term notes payable  705   - 
Long-term note payable, net  494   479 
Operating lease liabilities  3,566    
Other long-term liabilities  89   -   1,446   131 
Total liabilities  5,462   15,441   14,019   8,133 
                
Commitments and Contingencies                
                
Redeemable convertible preferred stock - Series F - 0 and 6,455 shares authorized, issued and outstanding at July 31, 2018 and October 31, 2017; liquidation preference - $0 and $17,750.  -   4,541 
        
STOCKHOLDERS’ EQUITY:                
Convertible preferred stock - 25,000,000 shares authorized, 0 and 3,230,655 shares issued and outstanding at July 31, 2018 and October 31, 2017, aggregate liquidation preference $0 and $2,140, respectively  -   109,995 
Common stock - $.001 par value; 250,000,000 shares authorized; 21,475,370 and 6,515,524 shares issued and outstanding at July 31, 2018 and October 31, 2017, respectively  21   7 
Preferred stock - 25,000,000 shares authorized, 0 shares issued and outstanding at March 31, 2019 and December 31, 2018      
Common stock - $.001 par value; 250,000,000 shares authorized; 21,749,239 and 21,447,088 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively  22   21 
Additional paid-in capital  394,362   149,173   424,955   414,840 
Accumulated other comprehensive income  53   36 
Accumulated deficit  (301,958)  (259,005)  (368,437)  (342,864)
Total stockholders’ equity  92,425   170   56,593   72,033 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $97,887  $20,152  $70,612  $80,166 

 

SeeThe accompanying notes toare an integral part of these condensed consolidated financial statements.statements

POLARITYTE, INC.

4

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, in thousands, except share and per share amounts)

 

  For the three months ended  For the nine months ended 
  July 31,  July 31, 
  2018  2017  2018  2017 
Net revenues $416  $-  $432  $- 
Cost of sales  229   -   231   - 
Gross profit  187   -   201   - 
Operating costs and expenses                
Product research and development  2,339   1,641   14,563   3,424 
Research and development - intellectual property acquired  -   -   -   104,693 
General and administrative  15,239   3,629   32,074   12,757 
   17,578   5,270   46,637   120,874 
Operating loss  (17,391)  (5,270)  (46,436)  (120,874)
                 
Other (expenses) income                
Interest income  146   3   189   10 
Change in fair value of derivatives  -   -   3,814   (8)
Loss on extinguishment of warrant liability  -   -   (520)  - 
Net loss from continuing operations  (17,245)  (5,267)  (42,953)  (120,872)
Gain (loss) from discontinued operations  -   (33)  -   (449)
Gain on sale of discontinued operations  -   100   -   100 
Gain (loss) from discontinued operations, net  -   67   -   (349)
Net loss  (17,245)  (5,200)  (42,953)  (121,221)
Deemed dividend - accretion of discount on Series F preferred stock  -   -   (1,290)  - 
Deemed dividend - exchange of Series F preferred stock  -   -   (7,057)  - 
Cumulative dividends on Series F preferred stock  -   -   (373)  - 
Net loss attributable to common stockholders $(17,245) $(5,200) $(51,673) $(121,221)
                 
Net loss per share, basic and diluted:                
Loss from continuing operations $(0.86) $(0.94) $(3.24) $(26.65)
Gain (loss) from discontinued operations  -   0.01   -   (0.08)
Deemed dividend - accretion of discount on preferred stock  -   -   (0.10)  - 
Deemed dividend - exchange of Series F preferred stock  -   -   (0.53)  - 
Cumulative dividends on Series F preferred stock  -   -   (0.03)  - 
Net loss attributable to common stockholders $(0.86) $(0.93) $(3.90) $(26.73)
Weighted average shares outstanding, basic and diluted:  20,092,848   5,568,072   13,256,693   4,534,967 
  For the Three Months Ended March 31, 
  2019  2018 
Net revenues        
Products $297  $3 
Services  1,168    
Total net revenues  1,465   3 
Cost of sales:        
Products  273   1 
Services  503    
Total costs of sales  776   1 
Gross profit  689   2 
Operating costs and expenses        
Research and development  5,352   5,572 
General and administrative�� 17,195   7,573 
Sales and marketing  3,953    
Total operating costs and expenses  26,500   13,145 
Operating loss  (25,811)  (13,143)
Other income (expense)        
Interest income, net  70   36 
Other income, net  168    
Change in fair value of derivatives     1,850 
Loss on extinguishment of warrant liability     (520)
Net loss  (25,573)  (11,777)
Deemed dividend – accretion of discount on Series F preferred stock     (698)
Deemed dividend – exchange of Series F preferred stock     (7,057)
Cumulative dividends on Series F preferred stock     (191)
Net loss attributable to common stockholders $(25,573) $(19,723)
Net loss per share, basic and diluted:        
Net loss $(1.18) $(1.26)
Deemed dividend – accretion of discount on Series F preferred stock     (0.07)
Deemed dividend – exchange of Series F preferred stock     (0.75)
Cumulative dividends on Series F preferred stock     (0.02)
Net loss attributable to common stockholders $(1.18) $(2.10)
Weighted average shares outstanding, basic and diluted:  21,594,699   9,377,211 

 

SeeThe accompanying notes toare an integral part of these condensed consolidated financial statements.statements

 

45

 

POLARITYTE, INC.

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTSTATEMENTS OF CHANGES INCOMPREHENSIVE LOSS

(Unaudited, in thousands)

  For the Three Months Ended March 31, 
  2019  2018 
Net loss $(25,573) $(11,777)
Other comprehensive income:        
Unrealized gain on available-for-sale securities      17    
Comprehensive loss $(25,556) $(11,777

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

6

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited, in thousands, except share and per share amounts)

 

  Preferred Stock  Common Stock  Additional Paid-in  Accumulated  Total Stockholders’ 
  Number  Amount  Number  Amount  Capital  Deficit  Equity 
Balance as of October 31, 2017  3,230,655  $109,995   6,515,524  $      7  $149,173  $(259,005) $170 
Issuance of common stock in connection with:                            
Conversion of Series A preferred stock to common stock  (3,146,671)  (769)  713,036   1   768   -   - 
Conversion of Series B preferred stock to common stock  (47,689)  (4,020)  794,820   1   4,019   -   - 
Conversion of Series C preferred stock to common stock  (2,578)  (201)  59,950   -   201   -   - 
Conversion of Series D preferred stock to common stock  (26,667)  (312)  44,445   -   312   -   - 
Conversion of Series E preferred stock to common stock  (7,050)  (104,693)  7,050,000   7   104,686   -   - 
Exchange of Series F preferred stock and dividends to common stock  -   -   1,003,391   1   13,060   -   13,061 
Extinguishment of warrant liability  -   -   151,871   -   3,045   -   3,045 
Option exercises  -   -   30,417   -   109   -   109 
Proceeds received from issuance of common stock, net of issuance costs of $556  -   -   4,791,819   4   92,672   -   92,676 
Stock-based compensation expense  -   -   308,387   -   27,674   -   27,674 
Deemed dividend - accretion of discount on Series F preferred stock  -   -   -   -   (1,290)  -   (1,290)
Cumulative dividends on Series F preferred stock  -   -   -   -   (373)  -   (373)
Series F preferred stock dividends paid in common stock  -   -   11,710   -   306   -   306 
Net loss  -   -   -   -   -   (42,953)  (42,953)
Balance as of July 31, 2018  -  $-   21,475,370  $21  $394,362  $(301,958) $92,425 

  For the Three Months Ended March 31, 2019 
  Common Stock  Additional Paid-in  Accumulated Other Comprehensive  Accumulated  Total Stockholders’ 
  Number  Amount  Capital  Income  Deficit  Equity 
December 31, 2018  21,447,088  $21  $414,840  $       36  $(342,864) $72,033 
Stock-based compensation expense         10,327         10,327 
Stock option exercises, net  228,937   1   1,126         1,127 
Vesting of restricted stock units, net   73,214                
Shares withheld for tax withholding on vesting of restricted stock         (1,338)        (1,338)
Other comprehensive income            17      17 
Net loss               (25,573)  (25,573)
March 31, 2019  21,749,239  $22  $424,955  $53  $(368,437) $56,593 

  For the Three Months Ended March 31, 2018 
  Preferred Stock  Common Stock  Additional Paid-in  Accumulated  Total Stockholders’ 
  Number  Amount  Number  Amount  Capital  Deficit  

Equity

 
December 31, 2017  1,656,838  $109,104   7,082,836  $7  $157,395  $(269,920) $(3,414)
Issuance of common stock in connection with:                            
Conversion of Series A preferred stock to common stock  (1,602,099)  (391)  363,036      391       
Conversion of Series B preferred stock to common stock  (47,689)  (4,020)  794,820   1   4,019       
Conversion of Series E preferred stock to common stock  (7,050)  (104,693)  7,050,000   7   104,686       
Exchange of Series F preferred stock and dividends to common stock        1,003,393   1   13,060      13,061 
Extinguishment of warrant liability        151,871      3,045      3,045 
Stock-based compensation expense               7,445      7,445 
Deemed dividend – accretion of discount on Series F preferred stock               (698     (698)
Cumulative dividends on Series F preferred stock               (191     (191)
Series F preferred stock dividends paid in common stock         11,708      306      306 
Net loss                  (11,777)  (11,777)
March 31, 2018    $   16,457,664  $16  $289,458  $(281,697) $7,777 

 

SeeThe accompanying notes toare an integral part of these condensed consolidated financial statements.statements

POLARITYTE, INC.

7

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited, in thousands)

 

 For the nine months ended
July 31,
  For the three months ended March 31, 
 2018 2017  2019 2018 
CASH FLOWS FROM OPERATING ACTIVITIES                
Net loss $(42,953) $(121,221) $(25,573) $(11,777)
Loss from discontinued operations  -   (349)
Loss from continuing operations  (42,953)  (120,872)
Adjustments to reconcile net loss from continuing operations to net cash used in continuing operating activities:        
Adjustments to reconcile net loss to net cash used in operating activities:        
Stock based compensation expense  10,289   7,445 
Change in fair value of derivatives     (1,850)
Depreciation and amortization  676   318 
Loss on extinguishment of warrant liability  520   -      520 
Depreciation and amortization  1,052   295 
Stock based compensation expense  27,674   10,696 
Amortization of intangible assets  51    
Amortization of debt discount  18   -   15    
Change in fair value of contingent consideration  20   -   20    
Research and development - intellectual property acquired  -   104,693 
Change in fair value of derivatives  (3,814)  8 
Other non-cash adjustments  (7)   
Changes in operating assets and liabilities:                
Accounts receivable  (329)  -   (76)   
Inventory  (255)  -   27    
Prepaid expenses and other current assets  (478)  -   (412)  (108)
Security deposits  (139)  (364)
Operating lease right-of-use assets  355    
Other assets     (137)
Accounts payable and accrued expenses  1,575   857   (1,929)  1,648 
Other current liabilities  425    
Deferred revenue  (80)   
Operating lease liabilities  (343)   
Other long-term liabilities  89   -   (4   
Net cash used in continuing operating activities  (17,020)  (4,687)
Net cash provided by discontinued operating activities  -   33 
Net cash used in operating activities  (17,020)  (4,654)  (16,566)  (3,941)
        
CASH FLOWS FROM INVESTING ACTIVITIES                
Purchase of property and equipment  (6,392)  (2,253)  (1,539)  (3,042)
Acquisition of IBEX  (2,258)  - 
Net cash used in continuing investing activities  (8,650)  (2,253)
Net cash provided by discontinued investing activities  45   10 
Purchase of available-for-sale securities  (5,220)   
Proceeds from maturities of available-for-sale securities  1,700    
Net cash used in investing activities  (8,605)  (2,243)  (5,059)  (3,042)
        
CASH FLOWS FROM FINANCING ACTIVITIES                
Proceeds from stock options exercised  109   1,123   1,127    
Net proceeds from the sale of common stock  92,676   2,278 
Payment of contingent consideration liability  (109)   
Principal payments on financing leases  (118)   
Net cash provided by financing activities  92,785   3,401   900    
Net (decrease) in cash and cash equivalents  (20,725)  (6,983)
                
Net increase (decrease) in cash and cash equivalents  67,160   (3,496)
Cash and cash equivalents - beginning of period  17,667   6,523   55,673   12,517 
Cash and cash equivalents - end of period $84,827  $3,027  $34,948  $5,534 
                
Supplemental schedule of non-cash investing and financing activities:                
Conversion of Series A preferred stock to common stock $769  $976 
Conversion of Series B preferred stock to common stock $4,020  $549 
Conversion of Series C preferred stock to common stock $201  $609 
Conversion of Series D preferred stock to common stock $312  $1,517 
Conversion of Series E preferred stock to common stock $104,693  $- 
Conversion of Series A, B, E preferred stock to common stock $  $109,104 
Exchange of Series F preferred stock for common stock $13,061  $-      13,061 
Extinguishment of warrant liability $2,525  $-      2,525 
Unpaid liability for acquisition of property and equipment $368  $108   170   363 
Warrant exchange for common stock shares $-  $78 
Deemed dividend - accretion of discount on preferred stock $1,290  $- 
Deemed dividend – accretion of discount on Series F preferred stock     698 
Cumulative dividends on Series F preferred stock $373  $-      191 
Series F preferred stock dividends paid in common stock $306  $-      306 
Contingent consideration for IBEX acquisition $278  $- 
Contingent consideration earned and recorded in accounts payable $30  $- 
Note payable issued as partial consideration for IBEX acquisition $1,220  $ 
Unpaid tax liability related to net share settlement of restricted stock units  1,338    
Unrealized gain on short-term investments and cash equivalents  17    
Reclassification of stock based compensation expense that was previously classified as a liability to paid-in capital  38    

 

SeeThe accompanying notes toare an integral part of these condensed consolidated financial statements.statements

 

68

 

POLARITYTE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

1. PRINCIPAL BUSINESS ACTIVITY AND BASIS OF PRESENTATION

 

PolarityTE, Inc. and subsidiaries (the “Company”) is a commercial-stage biotechnology and regenerative biomaterials company focused on transforming the lives of patients by discovering, designing and developing a range of regenerative tissue products and biomaterials for the fields of medicine, biomedical engineering and material sciences.

 

Discontinued OperationsChange in Fiscal Year end.. On June 23, 2017,January 11, 2019, the Company sold Majesco Entertainment Company, a Nevada corporation and wholly-owned subsidiaryBoard approved an amendment to the Restated Bylaws of the Company (“Majesco Sub”),changing the Company’s fiscal year end from October 31 to Zift Interactive LLC, a Nevada limited liability company (“Zift”), pursuant to a purchase agreement. Pursuant toDecember 31. As such, the termsend of the agreement,quarters in the Company sold 100%new fiscal year do not coincide with the end of the issued and outstanding shares of common stock of Majescoquarters in the Company’s previous fiscal years. The Company made this change to Zift, including all of the right, title and interest in and to Majesco Sub’s business of developing, publishing and distributing video game products through mobile and online digital downloading. Pursuant to the terms of the agreement, the Company will receive total cash consideration of approximately $100,000 ($5,000 upon signing the agreement and 19 additional monthly payments of $5,000) plus contingent consideration based on net revenuesalign its fiscal year end with a fair value of $0. As of July 31, 2018, the Company received $70,000 in cash consideration and $30,000 remains receivable.

Segments. The Company’s operations involve dissimilar products which are managed separately. Accordingly, it operates in two segments: 1) regenerative medicine and 2) veterinary sciences (“IBEX”).other companies within its industry.

 

The accompanying interim condensed consolidated financial statements of the Company are unaudited, but in the opinion of management, reflect all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the results for the interim period. Accordingly, they do not include all information and notes required by generally accepted accounting principles for complete financial statements. The results of operations for interim periods are not necessarily indicative of results to be expected for the entire fiscal year. The balance sheet at OctoberDecember 31, 20172018 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. These interim condensed consolidated financial statements should be read in conjunction with the Company’saudited consolidated financial statements and notes thereto for the yeartwo-month period ended OctoberDecember 31, 20172018 included in the Company’s Transition Report on Form 10-KT filed with the Securities and Exchange Commission on Form 10-K on January 30, 2018.March 18, 2019.

 

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Principles of ConsolidationConsolidation.. The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: PolarityTE, Inc., a Nevada corporation, Utah CRO Services, Inc., IBEX Preclinical Research, Inc., IBEX Property, LLC, Majesco Acquisition Corp. II and Majesco Sub (through the date sold). Majesco Sub was sold on June 23, 2017.subsidiaries. Significant intercompany accounts and transactions have been eliminated in consolidation. Utah CRO Services, Inc., IBEX Preclinical Research, Inc.,

Use of estimates.The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and IBEX Property, LLC are included fromassumptions that affect the reported amounts of assets and liabilities or the disclosure of gain or loss contingencies at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Among the more significant estimates included in these financial statements is the extent of progress toward completion of contracts, stock-based compensation, the valuation allowances for deferred tax benefits, and the valuation of tangible and intangible assets included in acquisitions. Actual results could differ from those estimates.

9

Segments.The Company’s operations are based in the United States and involve products and services which are managed separately. Accordingly, it operates in two segments: 1) regenerative medicine products and 2) contract services. The Chief Operating Decision Maker (CODM) is our Chief Executive Officer (CEO). The CODM allocates resources to and assesses the performance of each operating segment using information about its revenue and operating income (loss). Prior to the acquisition May 3, 2018.of IBEX, the Company operated in one segment.

 

Cash and Cash Equivalentscash equivalents.. Cash equivalents consist of highly liquid investments with original maturities of three months or less atfrom the date of purchase. At various times, the Company has deposits in excess of the Federal Deposit Insurance Corporation limit. The Company has not experienced any losses on these accounts.

Accounts Receivable.Accounts receivable consists of amounts due to the Company related to the sale of the Company’s core product SkinTE and veterinary science services. Accounts that are outstanding longer than the contractual payment terms are considered past due. The Company determines its allowance for doubtful accounts by considering a number of factors, including the length of time trade accounts receivable are past due and the customer’s current ability to pay its obligation to the Company. The Company writes off accounts receivable when they become uncollectible. As of July 31, 2018, there was no allowance for doubtful accounts.

 

Inventory.InvestmentsInventory comprises finished goods, which. Investments in debt securities have been classified as available-for-sale and are valuedcarried at fair value, with unrealized gains and losses reported as a component of accumulated other comprehensive income. Realized gains and losses are included in other income, net. The cost of securities sold is based on the lowerspecific-identification method. Interest on marketable securities is included in interest income, net. Investments with original maturities of cost or net realizable value, on a first-in, first-out basis. The Company evaluatesgreater than three months but less than one year from the carrying valuedate of its inventory on a regular basis, taking into account anticipated future sales comparedpurchase are classified as current. Investments with quantities on hand, andoriginal maturities of greater than one year from the remaining shelf lifedate of goods on hand.purchase are classified as non-current.

 

Property and EquipmentLoss Per Share.. Property and equipmentBasic loss per share of common stock is stated at cost. Depreciation and amortization is being provided forcomputed by dividing net loss attributable to common stockholders by the straight-line methodweighted average number of shares of common stock outstanding for the period. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share since the effects of potentially dilutive securities are antidilutive.

Leases. The Company determines if an arrangement is a lease at inception. Right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The classification of the Company’s leases as operating or finance leases along with the initial measurement and recognition of the associated ROU assets and lease liabilities is performed at the lease commencement date. The measurement of lease liabilities is based on the present value of future lease payments over the estimated useful liveslease term. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of future lease payments. The ROU asset is based on the measurement of the assets, generally range from threelease liability and also includes any lease payments made prior to eight years. Amortization of leasehold improvementsor on lease commencement and excludes lease incentives and initial direct costs incurred, as applicable. The lease terms may include options to extend or terminate the lease when it is providedreasonably certain the Company will exercise any such options. Rent expense for the Company’s operating leases is recognized on a straight-line basis over the shorter oflease term. Amortization expense for the ROU asset associated with its finance leases is recognized on a straight-line basis over the term of the lease orand interest expense associated with its finance leases is recognized on the lifebalance of the asset.

Capitalized Software Development Costs. Software development costs are capitalized once technological feasibility is established and management expects such costs to be recoverable against future revenues. Amounts related to software development that are not capitalized are charged immediately to expense. Capitalized costs are amortized straight-line overlease liability using the effective interest method based on the estimated useful life of three years.

7

POLARITYTE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

Goodwill and Intangible Assets.Goodwill represents the excess acquisition cost over the fair value of net tangible and intangible assets acquired. Goodwill is not amortized and is subject to annual impairment testing at the end of the third fiscal quarter or between annual tests if an event or change in circumstance occurs that would more likely than not reduce the fair value of a reporting unit below its carrying value. In testing for goodwill impairment, the Company has the option to first assess qualitative factors to determine whether the existence of events or circumstances lead to a determination that it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If, after assessing the totality of events and circumstances, the Company concludes that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, then performing the two-step impairment test is not required. If the Company concludes otherwise, it is required to perform the two-step impairment test. The goodwill impairment test is performed at the reporting unit level by comparing the estimated fair value of a reporting unit with its respective carrying value. If the estimated fair value exceeds the carrying value, goodwill at the reporting unit level is not impaired. If the estimated fair value is less than carrying value, further analysis is necessary to determine the amount of impairment, if any, by comparing the implied fair value of the reporting unit’s goodwill to the carrying value of the reporting unit’s goodwill.incremental borrowing rate.

 

The fair value of reporting units is based on widely accepted valuation techniques thatCompany has lease agreements with lease and non-lease components. As allowed under Topic 842, the Company believes market participants would use, althoughhas elected not to separate lease and non-lease components for any leases involving real estate and office equipment classes of assets and, as a result, accounts for the valuation process requires significant judgmentlease and often involves the use of significant estimates and assumptions.non-lease components as a single lease component. The Company utilizeshas also elected not to apply the recognition requirement of Topic 842 to leases with a market cap approach in estimating the fair valueterm of reporting units. The estimates and assumptions used in determining fair value could have a significant effect on whether12 months or not an impairment charge is recorded and the magnitudeless for all classes of such a charge. Adverse market or economic events could result in impairment charges in future periods.assets.

 

10

Intangible assets deemed to have finite lives are amortized on a straight-line basis over their estimated useful lives, which generally range from one to eleven years. The useful life is the period over which the asset is expected to contribute directly, or indirectly, to its future cash flows. Intangible assets are reviewed for impairment on an interim basis when certain events or circumstances exist. For amortizable intangible assets, impairment exists when the undiscounted cash flows exceeds its carrying value. At least annually, the remaining useful life is evaluated.

 

Impairment of Long-Lived Assets.The Company reviews long-lived assets, including property and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends, and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset over its fair value, determined based on discounted cash flows.

Income Taxes. The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company evaluates the potential for realization of deferred tax assets at each quarterly balance sheet date and records a valuation allowance for assets for which realization is not more likely than not.

StockStock- Based CompensationCompensation.. The Company measures all stock-based compensation to employees using a fair value method and records such expense in general and administrative and research and development expenses. Compensation expense for stock options with cliff vesting is recognized on a straight-line basis over the vesting period of the award, based on the fair value of the option on the date of grant. For stock options with graded vesting, the Company recognizes compensation expense over the service period for each separately vesting tranche of the award as though the award were in substance, multiple awards. Forfeitures are recognized as they occur.

POLARITYTE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

The fair value for options issued is estimated at the date of grant using a Black-Scholes option-pricing model. The risk-free rate is derived from the U.S. Treasury yield curve in effect at the time of the grant. The volatility factor is determined based on the Company’s historical stock prices. Forfeitures are recognized as they occur.

 

The value of restricted stock and restricted stock unit grants is measured based on the fair market value of the Company’s common stock on the date of grant and amortized over the vesting period of, generally, six months to three years.

 

Loss Per Share. Basic loss per share of commonThe accounting for non-employee options and restricted stock is computed by dividing net loss attributablesimilar to common stockholders by the weighted average numberthat of shares of common stock outstandingemployees. Stock-based compensation expense for the period. Diluted loss per share excludes the potential impact of common stock options, unvested shares of restricted stock and outstanding common stock purchase warrants because their effect would be anti-dilutive due to our net loss.

Commitments and Contingencies. We arenonemployee services has historically been subject to claims and litigation in the ordinary course of our business. We record a liability for contingencies when the amount is both probable and reasonably estimable. We record associated legal fees as incurred.

Accounting for Warrants. The Company accounts for the issuance of common stock purchase warrants issued in connection with the equity offerings in accordance with the provisions of ASC 815, Derivatives and Hedging (“ASC 815”). The Company classifies as equity any contracts that (i) require physical settlement or net-share settlement or (ii) gives the Company a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). The Company classifies as assets or liabilities any contracts that (i) require net-cash settlement (including a requirement to net-cash settle the contract if an event occurs and if that event is outside the control of the Company) or (ii) gives the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). In addition, under ASC 815, registered common stock warrants that require the issuance of registered shares upon exercise and do not expressly preclude an implied right to cash settlement are accounted for as derivative liabilities. The Company classifies these derivative warrant liabilities on the condensed consolidated balance sheet as a current liability.

Change in Fair Value of Derivatives. The Company assessed the classification of common stock purchase warrants as of the date of each offering and determined that certain instruments met the criteria for liability classification. Accordingly, the Company classified the warrants as a liability at their fair value and adjusts the instruments to fair valueremeasurement at each reporting period. This liability is subject to re-measurement at each balance sheet date untilas the warrants are exercised or expire,underlying equity instruments vest and any change in fair value iswas recognized as “change in fair valuean expense over the period during which services are received. Upon the adoption of derivatives” inASU 2018-07, Compensation – Stock Compensation on January 1, 2019, the consolidated statements of operations. The fair value ofvaluation was fixed at the warrantsimplementation date and will be recognized as well as other derivatives have been estimated usingan expense on a Monte-Carlo or Black-Scholes valuation model.straight-line basis over the remaining service period. 

 

Revenue RecognitionRecognition.. Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation.

In the regenerative medicine products segment, the Company records products revenues primarily from the sale of its regenerative tissue products. The Company sells its products to healthcare providers, primarily through direct sales representatives. Products revenues consists of a single performance obligation that the Company satisfies at a point in time. In general, the Company recognizes revenueproducts revenues upon delivery to the shipmentcustomer.

In the contract services segment, the Company records service revenues from the sale of products orits contract research services, which includes delivery of preclinical studies and other research services to unrelated third parties. Service revenues generally consist of a single performance obligation that the Company satisfies over time using an input method based on costs incurred to date relative to the total costs expected to be required to satisfy the performance obligation. The Company believes that this method provides a faithful depiction of the transfer of services when eachover the term of the following four criteriaperformance obligation based on the remaining services needed to satisfy the obligation. This requires the Company to make reasonable estimates of the extent of progress toward completion of the contract. As a result, unbilled receivables and deferred revenue are recognized based on payment timing and work completed. Generally, a portion of the payment is met: (i) persuasive evidencedue upfront and the remainder upon completion of an arrangement exists; (ii)the study, with most studies completing in less than a year. As of March 31, 2019 and December 31, 2018, the Company had unbilled receivables of $225,000 and $157,000 and deferred revenue of $90,000 and $170,000 respectively. The unbilled receivables balance is included in consolidated accounts receivable. Revenues of $151,000 was recognized during the three months ended March 31, 2019 that was included in the deferred revenue balance as of December 31, 2018.

Costs to obtain the contract are incurred for products revenues as they are delivered or servicesshipped and are performed; (iii) the sales price is fixed or determinable; and (iv) collectability is reasonably assured.expensed as incurred.

Recent Accounting Pronouncements

 

In August 2018, the FASB issued ASU 2018-13,EstimatesFair Value Measurement (Topic 820), Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement. The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities orASU modifies the disclosure of gainrequirements for fair value measurements by removing, modifying or loss contingencies atadding certain disclosures. The standard is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years with early adoption permitted. The Company is currently evaluating the date ofimpact that the standard will have on its consolidated financial statements and related disclosures.

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In June 2016, the reported amounts of revenues and expenses duringFASB issued ASU No. 2016-13,Financial Instruments-Credit Losses (Topic 326), which requires entities to measure all expected credit losses for financial assets held at the reporting periods. Amongdate based on historical experience, current conditions, and reasonable and supportable forecasts. This replaces the more significant estimates included in theseexisting incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost. This standard is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years with early adoption permitted. The Company is currently evaluating the impact that the standard will have on its consolidated financial statements are the valuation of warrant liability, valuation of derivative liability, stock-based compensation and the valuation allowances for deferred tax benefits. Actual results could differ from those estimates.related disclosures.

Recently Adopted Accounting Pronouncements

 

In April 2016,On January 1, 2019 the Financial Accounting Standard Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-09,Share-Based Payment: Simplifying the Accounting for Share-Based Payments. The standard addresses several aspects of the accounting for employee share-based payment transactions, including the accounting for income taxes, forfeitures and statutory tax withholding requirements, as well as classification in the statement of cash flows. The Company adopted ASU 2016-09 during the first quarter of fiscal 20182016-02,Leases (ASC 842) and the Company electedrelated amendments, which require lease assets and liabilities to account for forfeitures as they occur. The amendment was applied using a modified retrospective transition method. The provisions of ASU 2016-09 had no impactbe recorded on the Company’s consolidated financial statements.

In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. This new standard clarifies the definition of a business and provides a screen to determine when an integrated set of assets and activities is not a business. The screen requires that when substantially all of the fair value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business. This new standard is effectivebalance sheet for the Company on November 1, 2018 but may be adopted early. The ASU is applied prospectively to any transaction occurring within the period of adoption. The Company early adopted this guidance effective November 1, 2017. The adoption of this standard did not have a material impact on the Company's financial position, results of operations, or cash flows.

Recent Accounting Pronouncements.

In May 2014, the FASB issued ASU 2014-09,Revenue from Contractsleases with Customers (Topic 606), a new accounting standard that requires recognition of revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which an entity expects to be entitled in exchange for those goods or services. The FASB has also issued several updates to ASU 2014-09. The new standard supersedes U.S. GAAP guidance on revenue recognition and requires the use of more estimates and judgmentsterms greater than the present standards. It also requires additional disclosures regarding the nature, amount, timing and uncertainty of cash flows arising from contracts with customers. Topic 606 is effective for our fiscal year 2019 beginning on November 1, 2018. The Company is currently evaluating the overall effect that the standard will have on our consolidated financial statements and accompanying notes to the consolidated financial statements and which transition method to apply. As of July 31, 2018, the Company has completed and documented a preliminary assessment of the impact of the new revenue standard on its contracts with customers. The Company plans to finalize its assessment of the impact of the new revenue standard on its results of operations, internal controls and disclosures in the fourth quarter of 2018. The Company does not expect this new standard to have a material effect on the Company’s financial statements.

POLARITYTE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

In February 2016, FASB issued ASU 2016-02,Leases (Topic 842), which supersedes FASB ASC Topic 840, Leases (Topic 840) and provides principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors.twelve months. The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also requiredThe standard was adopted using the modified retrospective transition approach by applying the new standard to record a right-of-use asset and a lease liability for all leases with a termexisting at the date of greater than twelve months regardless of classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases. The standard is effective for annualthe initial application and interim periods beginning after December 15, 2018, with early adoption permitted upon issuance. The Company is currently assessing the potential impact of this guidance, but expects it to have a material impact on the Company’s balance sheet.not restating comparative periods.

 

In August 2016,We elected the FASB issued ASU 2016-15,Statementpackage of Cash Flows - Classificationpractical expedients permitted under the transition guidance, which allowed us to carryforward our historical lease classification, our assessment on whether a contract was or contains a lease, and our initial direct costs for any leases that existed prior to January 1, 2019. The impact of Certain Cash Receiptsthe adoption of ASC 842 on the accompanying Condensed Consolidated Balance Sheet as of January 1, 2019 was as follows (in thousands):

  December 31, 2018  

Adjustments Due to the

Adoption of ASC 842

  January 1, 2019 
Operating lease right-of-use assets $  $5,305  $5,305 
Liabilities:            
Operating lease liabilities $  $3,948  $3,948 
Other current liabilities  316   1,432   1,748 
Accounts payable and accrued expenses  6,508   (75)  6,433 

The adjustments due to the adoption of ASC 842 related to the recognition of operating lease right-of-use assets and Cash Payments, which addresses eight specific cash flow issues with the objective of reducingoperating lease liabilities for the existing diversity in practice in how certain cash receipts and cash payments are presented and classified in the statement of cash flows. The standard is effective for fiscal yearsoperating leases. A cumulative-effect adjustment to beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. The adoption of this update isaccumulated deficit was not expected to have a material impact on the Company’s consolidated financial statements and related disclosures.

In January 2017, the FASB issued ASU No. 2017-04,Intangibles - Goodwill and Other (Topic 350): Simplifying the Accounting for Goodwill Impairment.ASU No. 2017-04 removes Step 2 of the goodwill impairment test, which requires a hypothetical purchase price allocation. A goodwill impairment will now be the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. This standard will be applied prospectively and is effective for the Company beginning November 1, 2020. Early adoption is permitted for annual and interim goodwill impairment testing dates after January 1, 2017. The Company is currently evaluating the impact this standard will have on its financial statements.

In May 2017, the FASB issued ASU 2017-09,Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting. ASU 2017-09 provides clarity and reduces both (1) diversity in practice and (2) cost and complexity when applying the guidance in Topic 718, to a change to the terms or conditions of a share-based payment award. The amendments in ASU 2017-09 should be applied prospectively to an award modified on or after the adoption date. This ASU is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. The Company is currently assessing the potential impact of adopting ASU 2017-09 on its consolidated financial statements and related disclosures.required.

 

In June 2018, the FASB issued ASU 2018-07,Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-based Payment Accounting. The standard expands the scope of Topic 718 to include share-based payments issued to nonemployees for goods or services, simplifying the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years with early adoption permitted, including adoption in an interim period. The Company does not believe theadopted this ASU on January 1, 2019. The adoption of this standard willASU did not have a significantmaterial impact on itsthe Company’s consolidated financial statements given the limited number of nonemployee stock-based awards outstanding.and related disclosures.

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3. LIQUIDITY

 

3. LIQUIDITYThe Company has experienced recurring losses and cash outflows from operating activities. For the three months ended March 31, 2019 and 2018, the Company incurred net losses of $25.7 million and $11.8 million, respectively, with cash used in operating activities of $16.6 million and $3.9 million, respectively.

 

On April 12, 2018, the Company completed a public offering providing for the issuance and sale of 2,335,937 shares of the Company’s common stock, par value $0.001 per share, at an offering price of $16.00 per share, for net proceeds of approximately $34.6 million, after deducting offering expenses payable by the Company (see Note 10).

On June 7, 2018,10, 2019, the Company completed an underwritten offering with Cantor Fitzgerald & Co., as underwriter, providing for the issuance and sale of 2,455,8823,418,918 shares of the Company’s common stock, par value $0.001 per share, at an offering price of $23.65$8.51 per share, for net proceeds of approximately $58.0$28.7 million, after deducting offering expenses payable by the Company (see Note 10).Company.

 

Based upon the current status of ourthe Company’s product development and commercialization plans, we believethe Company believes that ourits existing cash, and cash equivalents and short-term investments will be adequate to satisfy ourits capital needs for at least the next 12 months from the date of filing. We anticipateHowever, the Company anticipates needing substantial additional financing to continue clinical deployment and commercialization of ourits lead product SkinTE, development of ourits other product candidates, and scaling the manufacturing capacity for ourits products and product candidates and prepare for commercial readiness. WeHowever, the Company will continue to pursue fundraising opportunities when available, but such financing may not be available in the future on terms favorable to us,the Company, if at all. If adequate financing is not available, wethe Company may be required to delay, reduce the scope of, or eliminate one or more of ourits product development programs. We planThe Company plans to meet ourits capital requirements primarily through issuances of equity securities, debt financing, revenue from product sales and future collaborations. Failure to generate revenue or raise additional capital would adversely affect ourthe Company’s ability to achieve ourits intended business objectives.

POLARITYTE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)4. FAIR VALUE

 

4. IBEX ACQUISITIONIn accordance withASC 820, Fair Value Measurements and Disclosures, financial instruments were measured at fair value using a three-level hierarchy which maximizes use of observable inputs and minimizes use of unobservable inputs:

 

Level 1: Observable inputs such as quoted prices in active markets for identical instruments. This methodology applies to our Level 1 investments, which are composed of money market funds.
Level 2: Quoted prices for similar instruments that are directly or indirectly observable in the market. This methodology applies to our Level 2 investments, which are composed of corporate debt securities, commercial paper, and U.S. government debt securities.
Level 3: Significant unobservable inputs supported by little or no market activity. Financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, for which determination of fair value requires significant judgment or estimation. This methodology applies to our Level 3 financial instruments, which are composed of contingent consideration.

On

13

Financial instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. There were no transfers within the hierarchy for any of the periods presented.

In connection with the offering of Units in September 2017 (see Note 10), the Company issued warrants to purchase an aggregate of 322,727 shares of common stock. These warrants were exercisable at $30.00 per share and expire in two years. The warrants were liabilities pursuant to ASC 815. The warrant agreement provided for an adjustment to the number of common shares issuable under the warrant or adjustment to the exercise price, including but not limited to, if: (a) the Company issues shares of common stock as a dividend or distribution to holders of its common stock; (b) the Company subdivides or combines its common stock (i.e., stock split); or (c) the Company issues new securities for consideration less than the exercise price. Under ASC 815, warrants that provide for down-round exercise price protection are recognized as derivative liabilities.

The Series F Preferred Shares contained an embedded conversion feature that was not clearly and closely related to the identified host instrument and, as such, was recognized as a derivative liability measured at fair value. The Company classified these derivatives on the consolidated balance sheet as a current liability.

As discussed in Note 10, both the warrants and the Series F Preferred Shares were exchanged for common stock on March 2,6, 2018.

The fair value of the bifurcated embedded conversion feature was estimated to be approximately $7.2 million at March 5, 2018, as calculated using the Monte Carlo simulation with the following assumptions:

  

Series F

Conversion

Feature

 
  March 5, 2018 
Stock price $20.05 
Exercise price $27.50 
Risk-free rate  2.2%
Volatility  88.2%
Term  1.5 

The fair value of the warrant liability was estimated to be approximately $2.5 million at March 5, 2018 as calculated using the Monte Carlo simulation with the following assumptions:

  Warrant Liability 
  March 5, 2018 
Stock price $20.05 
Exercise price $30.00 
Risk-free rate  2.2%
Volatility  88.2%
Term  1.5 

The following table sets forth the changes in the estimated fair value for our Level 3 classified derivative liabilities (in thousands):

  2017 Series F Preferred Stock – Warrant Liability  2017 Series F Preferred Stock – Embedded Derivative  Total Warrant and Derivative Liability 
Fair value – December 31, 2017 $3,388  $8,150  $11,538 
Change in fair value  (863)  (987)  (1,850)
Exchange / conversion to common shares $(2,525) $(7,163) $(9,688)
Fair value – March 31, 2018         

14

The following table sets forth the fair value of the Company’s financial assets and liabilities measured on a recurring basis by level within the fair value hierarchy as of March 31, 2019 and December 31, 2018 (in thousands):

  Fair Value Measurement as of March 31, 2019 
  Level 1  Level 2  Level 3  Total 
Assets:            
Money market funds $5  $  $  $5 
Commercial paper     17,332      17,332 
Corporate debt securities     7,992      7,992 
U.S. government debt securities     4,932      4,932 
Total $5  $30,256  $  $30,261 
Liabilities:                
Contingent consideration $  $  $203  $203 
Total $  $  $203  $203 

  Fair Value Measurement as of December 31, 2018 
  Level 1  Level 2  Level 3  Total 
Assets:            
Money market funds $7  $  $  $7 
Commercial paper     21,392      21,392 
Corporate debt securities     5,448      5,448 
U.S. government debt securities     3,226      3,226 
Total $7  $30,066  $  $30,073 
Liabilities:                
Contingent consideration $  $  $261  $261 
Total $  $  $261  $261 

In May 2018, the Company along with its wholly owned subsidiary, Utah CRO Services, Inc.,purchased the assets of a Nevada corporation (“Acquisition Co.”), entered into agreements withpreclinical research sciences business and related real estate from Ibex Group, L.L.C., a Utah limited liability company, and Ibex Preclinical Research, Inc., a Utah corporation (collectively, the “Seller” or “IBEX”) for the purchase of the assets and rights to the Seller’s preclinical research and veterinary sciences business and related real estate. The Company acquired this preclinical biomedical research facility in order to accelerate research and development of PolarityTE pipeline products. The business consists of a “good laboratory practices” (GLP) compliant preclinical research facility, including vivarium, operating rooms, preparation rooms, storage facilities, and surgical and imaging equipment. The real property includes two parcels in Cache County, Utah, consisting of approximately 1.75 combined gross acres of land, together with the buildings, structures, fixtures, and personal property located on the real property. The above was accounted for as a business combination.

The acquisition closed on May 3, 2018.. The aggregate purchase price was $3.8 million, of which $2.3 million was paid at closing and the balance satisfied by a promissory note payable to the SellerIBEX with an initial fair value of $1.2 million (see Note 9, for a description of the promissory note) and contingent consideration with an initial fair value of approximately $0.3 million. During the three and nine months ended July 31, 2018, the Company recorded approximately $38,000 of direct and incremental costs associated with acquisition-related activities. These costs were incurred primarily for banking, legal, and professional fees associated with the IBEX acquisition. These costs were recorded in general and administrative expenses in the consolidated statement of operations.million

 

During the three and nine months ended July 31, 2018, IBEX contributed approximately $172,000 to net revenues and approximately $124,000 to gross profit, respectively.

Purchase Price Allocation

The following table summarizes the preliminary purchase price allocation for the IBEX acquisition (in thousands):

Equipment

 $430 
Land and buildings  2,000 
Intangible assets  1,057 
Goodwill  278 
Accrued property taxes  (9)
Aggregate purchase price $3,756 

Less: Promissory note to seller

  1,220 
Contingent consideration  278 
Cash paid at closing $2,258 

As part of the acquisition of IBEX, the Company recorded a contingent consideration liability of $0.3 million in current liabilities in the condensed consolidated balance sheets. The contingent consideration represents the estimated fair value of future payments due to the Seller of IBEX based on IBEX’s revenue generated from studies quoted prior to but completed after the transaction. Contingent consideration iswas initially recognized at fair value as purchase consideration and is subsequently remeasured at fair value through earnings. The initial fair value of the contingent consideration was based on the present value of estimated future cash flows using a 20% discount rate. The contingent consideration is the payment of 15% of the actual revenues received for work on any study initiated within 18 months following the closing of the purchase on the basis of certain specific customer prospects that received service proposals prior to the closing, provided that the total amountpayments will not exceed $650,000. Adjustments to the fair value of the contingent consideration to be paid will not exceed $650,000. The subsequent increase in fair value of contingent consideration from acquisition to July 31, 2018 of approximately $20,000 was recognizedliability is included in general and administrative expense in the Company’s condensedaccompanying consolidated statementstatements of operations for the three and nine months ended July 31, 2018. The excess of the fair value of purchase consideration over the fair values of identifiable assets and liabilities is recorded as goodwill, including the value of the assembled workforce.operations.

 

The purchase price allocation for the IBEX acquisition is preliminary and subject to revision as additional information about fair value of assets acquired becomes available. Additional information that existed as of the acquisition date but at that time was unknown may become known during the remainder of the measurement period, a period not to exceed 12 months from the acquisition date.

15

 

Disclosure of pro-forma revenues and earnings attributable to the acquisition is excluded because it is impracticable to obtain complete historical financial records for IBEX Preclinical Research, Inc.

POLARITYTE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

The following table showssets forth the valuationchanges in the estimated fair value of our contingent consideration liability (in thousands) which is included in other current liabilities:

  Contingent Consideration 
Fair value – December 31, 2018 $261 
Change in fair value  20 
Earned and paid  (78)
Fair value – March 31, 2019 $203 

5. CASH EQUIVALENTS AND AVAILABLE FOR SALE MARKETABLE SECURITIES

Cash equivalents and available-for-sale marketable securities consisted of the individual identifiable intangible assets acquired along with their estimated remaining useful livesfollowing as of March 31, 2019 and December 31, 2018 (in thousands):

 

  

Approximate

Fair Value

  

Remaining Useful

Life (in years)

Non-compete agreement $410  4
Customer contracts / relationships  534  7 to 8
Trade names / trademarks  101  10 to 11
Backlog  12  Less than 1
Total intangible assets $1,057   
  March 31, 2019 
  Amortized Cost  Unrealized Gains  Unrealized Losses  Market Value 
Cash equivalents:                
Money market funds $5  $  $  $5 
Commercial paper  15,599   19      15,618 
U.S. government debt securities  4,926   6      4,932 
Total cash equivalents (1)  20,530   25      20,555 
Short-term investments:                
Commercial paper  1,708   6      1,714 
Corporate debt securities  7,970   22      7,992 
Total short-term investments  9,678   28      9,706 
Total $30,208  $53  $  $30,261 

(1)Included in cash and cash equivalents in the Company’s consolidated balance sheet as of March 31, 2019 in addition to $14.4 million of cash.

 

5. PREPAID EXPENSES AND OTHER CURRENT ASSETS

  December 31, 2018 
  Amortized Cost  Unrealized Gains  Unrealized Losses  Market Value 
Cash equivalents:                
Money market funds $7  $  $  $7 
Commercial paper  20,648   30      20,678 
U.S. government debt securities  3,224   2      3,226 
Total cash equivalents (1)  23,879   32      23,911 
Short-term investments:                
Commercial paper  714         714 
Corporate debt securities  5,444   5   (1)  5,448 
Total short-term investments  6,158   5   (1)  6,162 
Total $30,037  $37  $(1) $30,073 

(1)Included in cash and cash equivalents in the Company’s consolidated balance sheet as of December 31, 2018 in addition to $31.8 million of cash.

16

 

Prepaid expensesAll investments in debt securities held as of March 31, 2019 and other current assets consistDecember 31, 2018 had maturities of less than one year. For the following (in thousands):three months ended March 31, 2019, the Company recognized no material realized gains or losses on available-for-sale marketable securities.

  July 31, 2018  October 31, 2017 
Legal retainer $45  $15 
Prepaid insurance  84   69 
Other prepaids  586   126 
Other assets  -   27 
Total prepaid expenses and other current assets $715  $237 

 

6. PROPERTY AND EQUIPMENT, NET

 

PropertyThe following table presents the components of property and equipment, net consists of the following (in thousands):

 

  March 31, 2019  December 31, 2018 
Machinery and equipment $11,529  $8,276 
Land and buildings  2,000   2,000 
Computers and software  1,591   1,372 
Leasehold improvements  2,174   1,230 
Construction in progress  1,604   2,402 
Furniture and equipment  470   614 
Total property and equipment, gross  19,368   15,894 
Accumulated depreciation  (2,840)  (2,158)
Total property and equipment, net $16,528  $13,736 

  July 31, 2018  October 31, 2017 
Machinery and equipment $6,873  $2,418 
Land and buildings  2,000   - 
Computers and software  1,194   211 
Leasehold improvements  890   - 
Construction in progress  667   - 
Furniture and equipment  90   30 
Total property and equipment, gross  11,714   2,659 
Accumulated depreciation  (1,407)  (486)
Total property and equipment, net $10,307  $2,173 

 

Depreciation and amortization expense for property and equipment, including assets acquired under financing leases for the three months ended JulyMarch 31, 2019 and March 31, 2018 and 2017 was approximately $396,000 and $122,000, respectively. Depreciation expense for the nine months ended July 31, 2018 and 2017 was approximately $1,002,000 and $295,000, respectively.

POLARITYTE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

7. INTANGIBLE ASSETS

Intangible assets, net, consist of the following (in thousands):

  July 31, 2018  October 31, 2017 
Customer contracts / relationships $534  $- 
Trade names / trademarks  101   - 
Non-compete agreement  410   - 
Backlog  12     
Total intangible assets, gross  1,057   - 
Accumulated amortization  (50)  - 
Total intangible assets, net $1,007  $- 

Amortization expense for the three months and nine months ended July 31, 2018 was approximately $50,000.

The future amortization of these intangible assets is expected to be as follows (in thousands):

 

Fiscal year 2018 (three months remaining) $50 
Fiscal year 2019  195 
Fiscal year 2020  189 
Fiscal year 2021  189 
Fiscal year 2022  138 
Thereafter  246 
  $1,007 
  For the Three Months Ended March 31, 
  2019  2018 
General and administrative expense $357  $ 
Research and development expense  319   318 
Total depreciation and amortization expense $676  $318 

7. LEASES

The Company leases facilities and certain equipment under noncancelable leases that expire at various dates through November 2024. These leases require monthly lease payments that may be subject to annual increases throughout the lease term. Certain of these leases may include options to extend or terminate the lease at the election of the Company. These optional periods have not been considered in the determination of the right-of-use-assets or lease liabilities associated with these leases as the Company did not consider it reasonably certain it would exercise the options.

17

As of March 31, 2019, the maturities of our operating and finance lease liabilities were as follows (in thousands):

  Operating leases  Finance leases 
2019 (excluding the three months ended March 31, 2019) $1,419  $459 
2020  1,815   605 
2021  1,458   602 
2022  1,216   327 
2023     255 
2024     42 
Total lease payments  5,908   2,290 
Less:        
Imputed interest  (860)  (399)
Total $5,048  $1,891 

Supplemental balance sheet information related to leases was as follows (in thousands):

Finance leases   
  As of March 31, 2019 
Finance lease right-of-use assets included within property and equipment, net $2,472 
     
Current finance lease liabilities included within other current liabilities $445 
Non-current finance lease liabilities included within other long-term liabilities  1,446 
Total $1,891 

Operating leases   
  As of March 31, 2019 
Current operating lease liabilities included within other current liabilities $1,482 
Operating lease liabilities – non current  3,566 
Total $5,048 

The components of lease expense were as follows (in thousands):

  Three Months Ended
March 31, 2019
 
Operating lease costs included within operating costs and expenses $482 
Finance lease costs:    
Amortization of right of use assets $138 
Interest on lease liabilities  23 
Total $161 

Supplemental cash flow information related to leases was as follows (in thousands):

  Three Months Ended
March 31, 2019
 
Cash paid for amounts included in the measurement of lease liabilities:    
Operating cash flows from operating leases $470 
Operating cash flows from finance leases  23 
Financing cash flows from finance leases  118 
Lease liabilities arising from obtaining right-of-use assets:    
Finance leases $1,824 
Lease payments made in prior period reclassified to property and equipment  535 
Operating leases  9 

As of March 31, 2019, the weighted average remaining operating lease term is 3.3 years and the weighted average discount rate used to determine the operating lease liability was 9.90%. The weighted average remaining finance lease term is 4.0 years and the weighted average discount rate used to determine the finance lease liability was 9.68%.

18

 

8. ACCOUNTS PAYABLE AND ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

 

AccountsThe following table presents the major components of accounts payable and accrued expenses consist of the following (in thousands):

 

 July 31, 2018  October 31, 2017  March 31, 2019  December 31, 2018 
Accounts payable $82  $25  $1,967  $2,918 
Due to Zift  -   36 
Medical study and supplies  186   362 
Property and equipment purchases  368   54 
Salaries and other compensation  1,108   574   1,323   1,280 
Other accruals  1,302   1,670 
Legal and accounting  1,050   555   752   640 
Other accruals  1,073   333 
Total accounts payable and accrued expenses $3,867  $1,939  $5,344  $6,508 

 

Salaries and other compensation include accrued payroll expense, accrued bonus, and estimated employer 401K401(k) plan contributions.

Other current liabilities is comprised of the current portion of operating lease liabilities and finance lease liabilities, contingent consideration, and short term debt. The short term debt had a balance of $0.4 million as of March 31, 2019, while the other components are disclosed in the footnotes above.

 

9. LONG TERM NOTESNOTE PAYABLE

 

In connection with the IBEX Acquisition described in Note 4,May 2018, the Company issued a promissory note payable to the Seller with an initial fair value of $1.22$1.2 million. The promissory note has a principal balance of $1,333,333$1.3 million and bears interest at a rate of 3.5% interest per annum. Principal and interest are payable in five equal installments beginningthat began on November 3, 2018 and continuing on each six-month anniversary thereafter (“Payment Date”). The promissory note may be prepaid by the Company at anytimeany time and becomes due and payable at the earlier of the maturity date of November 3, 2020 or upon an event of default, which includes failure to pay any installment on each Payment Date, breach of any negative covenants, insolvency or bankruptcy. Upon the occurrence of an event of default, the promissory note will bear an accelerated interest rate of 7% per annum from the date of the event of default.

 

The Company initially recognized the promissory note at its fair value, using an estimated market rate of interest for the Company, which was higher than the promissory note’s stated rate. The result of imputing a market rate of interest resulted in an initial discount to the principal balance of approximately $113,000, which is being amortized to interest expense over the term of the promissory note using the effective interest method. The unamortized debt discount was $53,000 and $68,000 at March 31, 2019 and December 31, 2018, respectively. Amortization of debt discount of $18,000$15,000 was included in interest expenseincome, net for the three and nine months ended JulyMarch 31, 2018.2019

19

 

10. PREFERRED SHARES AND COMMON SHARES

 

Common Stock Issuance

On April 12, 2018, the Company completed a public offering providing for the issuance and sale of 2,335,937 shares of the Company’s common stock, par value $0.001 per share, at an offering price of $16.00 per share, for net proceeds of approximately $34.6 million, after deducting offering expenses payable by the Company.

On June 7, 2018, the Company completed an underwritten offering with Cantor Fitzgerald & Co., as underwriter, providing for the issuance and sale of 2,455,882 shares of the Company’s common stock, par value $0.001 per share, at an offering price of $23.65 per share, for net proceeds of approximately $58.0 million, after deducting offering expenses payable by the Company.

Exchange of 100% of Outstanding Series F Preferred Stock Shares and Warrants

 

On September 20, 2017, the Company sold an aggregate of $17,750,000 worth of units (the “Units”) of the Company’s securities (the “Units”) to accredited investors at a purchase price of $2,750 per Unit. Each Unit with each Unit consistingconsisted of (i) one share of the Company’s newly authorized 6% Series F Convertible Preferred Stock, par value $0.001 per share (the “Series F Preferred Shares”), which were each convertible into one hundred (100) shares of the Company’s common stock, and (ii) a two-year warrant to purchase up to 322,727 shares of the Company’s common stock, at an exercise price of $30.00 per share.

POLARITYTE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

The Series F Preferred Shares were convertible into shares of the Company’s common stock based on a conversion calculation equal to the stated value of the Series F Preferred Shares, plus all accrued and unpaid dividends, if any, on such Series F Preferred Shares, as of such date of determination, divided by the conversion price. The stated value of each Series F Preferred Share was $2,750 and the initial conversion price was $27.50 per share, each subject to adjustment for stock splits, stock dividends, recapitalizations, combinations, subdivisions or other similar events.

 

On the two-year anniversary of the initial issuance date, any Series F Preferred Shares outstanding and not otherwise already converted, shall,would, at the option of the holder, will either (i) automatically convert into common stock of the Company at the conversion price then in effect or (ii) be repaid by the Company based on the stated value of such outstanding Series F Preferred Shares.

 

The warrants issued in connection with the Series F Preferred Shares were determined to be liabilities pursuant to ASC 815. The warrant agreement provided for an adjustment to the number of common shares issuable under the warrant and/or adjustment to the exercise price, including but not limited to, if: (a) the Company issued shares of common stock as a dividend or distribution to holders of its common stock; (b) the Company subdivided or combined its common stock (i.e., stock split); or (c) adjustment of exercise price upon issuance ofthe Company issues new securities atfor consideration less than the exercise price. Under ASC 815, warrants that provide for down-round exercise price protection are recognized as derivative liabilities.

20

 

The conversion feature within the Series F Preferred Shares was determined to not be clearly and closely related to the identified host instrument and, as such, was recognized as a derivative liability measured at fair value pursuant to ASC 815.

 

The initial fair value of the warrants and bifurcated embedded conversion feature, estimated to be approximately $4.3 million and $9.3 million, respectively, was deducted from the gross proceeds of the Unit offering to arrive at the initial discounted carrying value of the Series F Preferred Shares. The resulting discount to the aggregate stated value of the Series F Preferred Shares of approximately $13.6 million was recognized as accretion using the effective interest method similar to preferred stock dividends, over the two-year period prior to optional redemption by the holders.

 

On March 6, 2018, the Company entered into separate exchange agreements (the “Exchange Agreements”) with holders (each a “Holder”, and collectively the “Holders”) of 100% of the Company’s outstanding Series F Preferred Shares, and the Company’s warrants to purchase shares of the Company’s common stock issued in connection with the Series F Preferred Shares (such “Warrants” and Series F Preferred Shares collectively referred to as the “Exchange Securities”) to exchange the Exchange Securities and unpaid dividends on the Series F Preferred Shares for common stock (the “Exchange”).

 

The Exchange resulted in the following issuances: (A) all outstanding Series F Preferred Shares were converted into 972,070 shares of restricted common stock at an effective conversion price of $18.26 per share of common stock (the closing price of Common Stock on the NASDAQ Capital Market on February 26, 2018); (B) the right to receive 6% dividends underlying Series F Preferred Shares was terminated in exchange for 31,321 shares of restricted common stock; (C) 322,727 Warrants to purchase common stock were exchanged for 151,871 shares of restricted common stock; and (D) the Holders of the Warrants relinquished any and all other rights pursuant to the Warrants, including exercise price adjustments.

 

As part of the Exchange, the Holders also relinquished any and all other rights related to the issuance of the Exchange Securities, the respective governing agreements and certificates of designation, including any related dividends, adjustment of conversion and exercise price, and repayment option. The existing registration rights agreement with the holders of the Series F Preferred Shares was also terminated and the holders of the Series F Preferred Shares waived the obligation of the Company to register the common shares issuable upon conversion of Series F Preferred Shares or upon exercise of the warrants, and waived any damages, penalties and defaults related to the Company failing to file or have declared effective a registration statement covering those shares.

 

The exchange of all outstanding Series F Preferred Shares, and the holders’ right to receive 6% dividends, for common stock of the Company was recognized as follows:

 

Fair market value of 1,003,391 shares of common stock issued at $20.05 (Company’s closing stock price on March 5, 2018) in exchange for Series F Preferred Shares and accrued dividends $20,117,990 
Fair market value of 1,003,393 shares of common stock issued at $20.05 (Company’s closing stock price on March 5, 2018) in exchange for Series F Preferred Shares and accrued dividends $20,117,990 
Carrying value of Series F Preferred Shares at March 5, 2018, including dividends  (5,898,274)  (5,898,274)
Carrying value of bifurcated conversion option at March 5, 2018  (7,162,587)  (7,162,587)
Deemed dividend on Series F Preferred Shares exchange $7,057,129  $7,057,129 

21

 

As the Warrants were classified as a liability, the exchange of the Warrants for common shares should bewas recognized as a liability extinguishment. As of March 5, 2018, the fair market value of the 151,871 common shares issued in the Exchange was $3,045,034 and the fair value of the common stock warrant liability was $2,525,567 resulting in a loss on extinguishment of warrant liability of $519,467 during the ninethree months ended JulyMarch 31, 2018.

POLARITYTE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

The Company recognized accretion of the discount to the stated value of the Series F Preferred Shares of approximately $1,290,000 in$698,000 during the ninethree months ended JulyMarch 31, 2018, respectively, as a reduction of additional paid-in capital and an increase in the carrying value of the Series F Preferred Shares. The accretion is presented in the Statement of Operations as a deemed dividend, increasing net loss to arrive at net loss attributable to common stockholders.

 

Preferred Stock Conversion and Elimination

On February 6, 2018, 15,756 shares of Series B Convertible Preferred Stock (“Series B Preferred Shares”) were converted into 262,606 shares of common stock.

 

On March 6, 2018, the Company received conversion notices (in accordance with original terms) from holders of 100% of the outstanding shares of Series A Convertible Preferred Stock (the “Series A Preferred Shares”), Series B Preferred Shares and Series E Convertible Preferred Stock (the “Series E Preferred Shares”) and issued an aggregate of 7,945,250 shares of common stock to such holders.

 

The shares of Series E Preferred SharesStock were held by Dr. Denver Lough, the Company’s Chief Executive Officer. On March 6, 2018, the Company entered into a new registration rights agreement (the “Lough Registration Rights Agreement”) with Dr. Lough, pursuant to which the Company agreed to file a registration statement to register the resale of 7,050,000 shares of Common Stock issued upon conversion of the Series E Preferred Shares within six months, to cause such registration statement to be declared effective by the Securities and Exchange Commission as promptly as possible following its filing and, with certain exceptions set forth in the Lough Registration Rights Agreement, to maintain the effectiveness of the registration statement until all of such shares have been sold or are otherwise able to be sold pursuant to Rule 144 under the Securities Act without restriction. Any sales of shares underOn March 14, 2019, the Company’s registration statement were subject to certain limitations as specified with more particularity inobligation was waived, and the Lough Registration Rights Agreement. In April 2018,Agreement amended to provide that Dr. Lough entered intomay demand registration by written request to the Company. Dr. Lough has not made a lock up agreementdemand for 180 days, which prohibits him from selling any shares that may be registered until October 2018.filing a registration statement.

 

On March 7, 2018, the Company filed a Certificate of Elimination with the Secretary of State of the State of Delaware terminating the Company’s Series A, Series B, Series C, Series D, Series E and Series F Preferred Stock. As a result, the Company has 10,000,00025,000,000 shares of authorized and unissued preferred stock as of March 31, 2019 with no designation as to series.

 

ConvertibleThere was no convertible preferred stock activity for the nine months ended Julyoutstanding as of March 31, 2018 consisted of the following:

2019 and December 31, 2018.

 

  

Shares

Outstanding -

October 31, 2017

  First Quarter 2018 -Preferred Stock Conversions  First Quarter 2018 - Common Stock Shares Issued  Second Quarter 2018 -Preferred Stock Conversions and Series F Exchange  Second Quarter 2018 - Common Stock Shares Issued  Year to Date 2018 -Preferred Stock Conversions and Series F Exchange  Year to Date 2018 - Common Stock Shares Issued 
Series A  3,146,671   (1,544,572)  350,000   (1,602,099)  363,036   (3,146,671)  713,036 
Series B  47,689   -   -   (47,689)  794,820   (47,689)  794,820 
Series C  2,578   (2,578)  59,950   -   -   (2,578)  59,950 
Series D  26,667   (26,667)  44,445   -       (26,667)  44,445 
Series E  7,050   -   -   (7,050)  7,050,000   (7,050)  7,050,000 
Series F  6,455   -   -   (6,455)  972,070   (6,455)  972,070 
Total  3,237,110   (1,573,817)  454,395   (1,663,293)�� 9,179,926   (3,237,110)  9,634,321 
22

 

11. FAIR VALUE MEASUREMENTSSTOCK-BASED COMPENSATION

 

In accordance with ASC 820, Fair Value Measurements, financial instruments were measured at fair value using a three-level hierarchy which maximizes use of observable inputs and minimizes use of unobservable inputs:

Level 1: Observable inputs such as quoted prices in active markets for identical instruments
Level 2: Quoted prices for similar instruments that are directly or indirectly observable in the market
Level 3: Significant unobservable inputs supported by little or no market activity. Financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, for which determination of fair value requires significant judgment or estimation.

POLARITYTE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

In connection with the offering of Units in September 2017, the Company issued warrants to purchase an aggregate of 322,727 shares of common stock. These warrants were exercisable at $30.00 per share and expire in two years. The warrants were liabilities pursuant to ASC 815. The warrant agreement provided for an adjustment to the number of common shares issuable under the warrant and/or adjustment to the exercise price, including but not limited to, if: (a) the Company issues shares of common stock as a dividend or distribution to holders of its common stock; (b) the Company subdivides or combines its common stock (i.e., stock split); (c) adjustment of exercise price upon issuance of new securities at less than the exercise price. Under ASC 815, warrants that provide for down-round exercise price protection are recognized as derivative liabilities.

The Series F Preferred Shares contained an embedded conversion feature that was not clearly and closely related to the identified host instrument and, as such, was recognized as a derivative liability measured at fair value. The Company classified these derivatives on the consolidated balance sheet as a current liability.

As noted in Note 10. above, both the warrants and the Series F Preferred Shares were exchanged for common stock on March 6, 2018.

The fair value of the bifurcated embedded conversion feature was estimated to be approximately $7.2 million and $9.2 million, respectively, at March 5, 2018 and October 31, 2017 as calculated using a Monte Carlo simulation with the following assumptions:

  Series F Conversion Feature 
   March 5, 2018   October 31, 2017 
Stock price $20.05  $25.87 
Exercise price $27.50  $27.50 
Risk-free rate  2.158%  1.581%
Volatility  88.2%  96.0%
Term  1.54   1.89 

The fair value of the warrant liability was estimated to be approximately $2.5 million and $4.3 million, respectively, at March 5, 2018 and October 31, 2017 as calculated using the Monte Carlo simulation with the following assumptions:

   Warrant Liability 
   March 5, 2018   October 31, 2017 
Stock price $20.05  $25.87 
Exercise price $30.00  $30.00 
Risk-free rate  2.158%  1.581%
Volatility  88.2%  96.0%
Term  1.54   1.89 

Financial instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.

The fair value hierarchy of financial instruments, measured at fair value on a recurring basis on the consolidated balance sheets as of July 31, 2018 is as follows (in thousands):

  Fair Value Measurement as of July 31, 2018 
  Level 1  Level 2  Level 3  Total 
Liabilities            
Contingent consideration    -  -  268  268 
Total $-  $-  $268  $268 

The fair value hierarchy of financial instruments, measured at fair value on a recurring basis on the consolidated balance sheets as of October 31, 2017 is as follows (in thousands):

  Fair Value Measurement as of October 31, 2017 
  Level 1  Level 2  Level 3  Total 
Liabilities            
Warrant liability $-  $-  $4,256  $4,256 
Derivative liability     -   -   9,246   9,246 
Total $-  $-  $13,502  $13,502 

The following table sets forth the changes in the estimated fair value for our Level 3 classified contingent consideration (in thousands):

  Contingent Consideration 
Fair value – October 31, 2017 $- 
IBEX acquisition – May 3, 2018 $278 
Change in fair value  20 
Earned and moved to accounts payable  (30)
Fair value - July 31, 2018 $268 

POLARITYTE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

The following table sets forth the changes in the estimated fair value for our Level 3 classified derivative liabilities (in thousands):

  

2017 Series F

Preferred Stock -

Warrant Liability

  

2017 Series F

Preferred Stock - Embedded Derivative

  Total Warrant and Derivative Liability 
Fair value - October 31, 2017 $4,256  $9,246  $13,502 
Change in fair value  (1,731)  (2,083)  (3,814)
Exchange / conversion to common shares  (2,525)  (7,163)  (9,688)
Fair value - July 31, 2018 $-  $-  $- 

The carrying value of the long-term promissory note approximates fair value, due to the imputation of interest on the note to an estimated market rate of interest. The carrying amounts of accounts payable, accrued expenses, and accounts receivable approximate fair value as these accounts are largely current and short term in nature.

12. STOCK BASED COMPENSATION ARRANGEMENTS

InFor the three and nine months ended JulyMarch 31, 20182019 and 2017,2018, the Company recorded stock-based compensation expense related to restricted stock awards and stock options as follows (in thousands):

 

  

For the Three Months Ended

July 31,

 
  2018  2017 
General and administrative expense:        
Continuing operations $8,718  $2,464 
Discontinued operations  -   274 
   8,718   2,738 
Research and development expense:        
Continuing operations  1,204   452 
Total stock-based compensation expense $9,922  $3,190 
  For the Three Months Ended March 31 
  2019  2018 
General and administrative expense $9,037  $5,772 
Research and development expense  1,084   1,673 
Sales and marketing expense  168   - 
Total stock-based compensation expense $10,289  $7,445 

Incentive Compensation Plans

 

  

For the Nine Months Ended

July 31,

 
  2018  2017 
General and administrative expense:        
Continuing operations $22,783  $10,057 
Discontinued operations  -   1,118 
   22,783   11,175 
Research and development expense:        
Continuing operations  4,891   639 
Total stock-based compensation expense $27,674  $11,814 

2019 Plan

On October 5, 2018, the Company’s Board of Directors (the “Board”) approved the Company’s 2019 Equity Incentive Plan (the “2019 Plan”). The 2019 Plan provides for the grant of incentive stock options, nonqualified stock options, restricted stock, restricted stock units, stock appreciation rights and other types of stock-based awards to the Company’s employees, officers, directors and consultants. The Compensation Committee of the Board will administer the 2019 Plan, including determining which eligible participants will receive awards, the number of shares of common stock subject to the awards and the terms and conditions of such awards. Up to 3,000,000 shares of common stock are issuable pursuant to awards under the 2019 Plan. Unless earlier terminated by the Board, the 2019 Plan shall terminate at the close of business on October 5, 2028. As of March 31, 2019, the Company had approximately 2,032,001 shares available for future issuances under the 2019 Plan.

2017 Plan

On December 1, 2016, the Company’s Board of Directors (the “Board”) approved the Company’s 2017 Equity Incentive Plan (the “2017 Plan”). The purpose of the 2017 Plan is to promote the success of the Company and to increase stockholder value by providing an additional means through the grant of awards to attract, motivate, retain and reward selected employees, consultants and other eligible persons. The 2017 Plan provides for the grant of incentive stock options, nonqualified stock options, restricted stock, restricted stock units, stock appreciation rights and other types of stock-based awards to the Company’s employees, officers, directors and consultants. The Compensation Committee of the Board will administer the 2017 Plan, including determining which eligible participants will receive awards, the number of shares of common stock subject to the awards and the terms and conditions of such awards. Up to 7,300,000 (increased from 3,450,000 in October 2017) shares of common stock are issuable pursuant to awards under the 2017 Plan. Unless earlier terminated by the Board, the 2017 Plan shall terminate at the close of business on December 1, 2026. As of March 31, 2019, the Company had approximately 171,767 shares available for future issuances under the 2017 Plan.

23

2014 Plan

In the fiscal year ended October 31, 2015, the Company adopted the 2014 Plan, an omnibus equity incentive plan administered by the Company’s board of directors, or by one or more committees of directors appointed by the Board, pursuant to which the Company may issue up to 2,250,000 shares of the Company’s common stock under equity-linked awards to certain officers, employees, directors and consultants. The 2014 Plan permits the grant of stock options, including incentive stock options and nonqualified stock options, stock appreciation rights, restricted shares, restricted share units, cash awards, or other awards, whether at a fixed or variable price, upon the passage of time, the occurrence of one or more events, or the satisfaction of performance criteria or other conditions, or any combination thereof. As of March 31, 2019, the Company had approximately 1,927,453 shares available for future issuances under the 2014 Plan.

Stock Options

 

A summary of the Company’s employee and non-employee stock option activity in the ninefor three months ended JulyMarch 31, 20182019 is presented below:

 

  

Number of

shares

  

Weighted-Average

Exercise Price

 
Outstanding - October 31, 2017  3,525,530  $            6.34 
Granted  1,768,000  $25.22 
Exercised  (30,794) $3.87 
Forfeited  (34,167) $18.90 
Outstanding - July 31, 2018  5,228,569  $12.65 
Options exercisable - July 31, 2018  3,028,208  $7.64 
Weighted-average fair value of options granted during the period     $18.33 
  

Number of

shares

  

Weighted-Average

Exercise Price

 
Outstanding – December 31, 2018  6,499,885  $14.02 
Granted  578,701  $15.93 
Exercised (1)  (283,250) $3.99 
Forfeited  (218,520) $11.98 
Outstanding – March 31, 2019  6,576,816  $14.56 
Options exercisable, March 31, 2019  4,233,763  $11.21 
Weighted-average grant date fair value of options granted during the three months ended March 31, 2019     $11.44 

POLARITYTE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

A summary of the Company’s non-employee stock option activity in the nine months ended July 31, 2018 is presented below:

  

Number of

shares

  

Weighted-Average

Exercise Price

 
Outstanding - October 31, 2017 $293,000  $            19.61 
No activity  -  $- 
Outstanding – July 31, 2018  293,000  $19.61 
Options exercisable - July 31, 2018  136,542  $17.12 
(1)The number of exercised options includes shares withheld on behalf of employees to satisfy minimum statutory tax withholding requirements. 

 

Stock options are generally granted to employees or non-employees at exercise prices equal to the fair market value of the Company’s common stock atof the dates ofday prior to the grant. Stock options generally vest over one to three years and have a term of five to ten years. The total fair value of employeeall options granted during the ninethree months ended JulyMarch 31, 20182019 was approximately $32.4$6.6 million. The intrinsic value of options outstanding at JulyMarch 31, 20182019 was $60.1$18.5 million. The intrinsic value of options exercised during the ninethree months ended JulyMarch 31, 20182019 was $583,000.$1.9 million. The weighted average remaining contractual term of outstanding and exercisable options at JulyMarch 31, 20182019 was 8.88.6 years and 8.58.1 years, respectively. As of July 31, 2018, there was approximately $19.6 million of unrecognized compensation cost related to stock options, which is expected to be recognized over a remaining weighted-average vesting period of 0.6 years.

 

The fair value of each option grant is estimated on the date of grant using the Black-Scholes option-pricing model with the following assumptions for the ninethree months ended JulyMarch 31, 2018:2019:

 

Risk free annual interest rate  2.01%-3.042.2%-2.7%
Expected volatility  80.86-85.6280.8%-97.5%
Expected lifeterm of options (years)  5.00-6.015.0-6.0 
Assumed dividends  None 

 

24

Restricted

The fair value of employee and non-employee stock option grants is recognized over the vesting period of, generally, one to three years. As of March 31, 2019, there was approximately $17.0 million of unrecognized compensation cost related to non-vested employee and restrictednon-employee stock unitsoption awards, which is expected to be recognized over a remaining weighted-average vesting period of 0.7 years.

Restricted-stock activity for employees and non-employees infor the ninethree months ended JulyMarch 31, 2018:2019:

 

 

Number of

shares

 

Weighted-Average

Grant-Date

Fair Value

  

Number of

shares

 Weighted-Average Grant-Date Fair Value 
Unvested - October 31, 2017  227,132  $             7.83 
Unvested - December 31, 2018  651,110  $23.65 
Granted  308,387  $27.48   40,000   16.43 
Vested(1)  (187,488) $11.53   (129,235)  21.14 
Unvested – July 31, 2018  348,031  $23.25 
Forfeited  (45,000)  24.43 
Unvested – March 31, 2019  516,875   23.98 

(1)The number of vested restricted stock units includes shares that were withheld on behalf of employees to satisfy the minimum statutory tax withholding requirements.

 

The total fair value of restricted stock and restricted stock units grantedvested during the ninethree months ended JulyMarch 31, 20182019, was approximately $8.5$2.7 million.

 

The fair value of restricted stock and restricted stock unit grants is measured based on the fair market value of the Company’s common stock on the date of grant and amortizedrecognized over the vesting period of, generally, six months to three years. As of JulyMarch 31, 2018,2019, there was approximately $6.0$6.6 million of unrecognized compensation cost related to unvested restricted stock and restricted stock unit awards, which is expected to be recognized over a remaining weighted-average vesting period of 1.0 year.

 

13.12. INCOME TAXES

 

The Company calculateshas evaluated its provision for federalincome tax positions and state income taxes based on currentdetermined that no material uncertain tax law.positions existed at March 31, 2019. The Tax CutsCompany does not expect a significant change in its unrecognized tax benefits within the next twelve months.

As of March 31, 2019 and Jobs Act (tax reform) was enacted on December 22, 2017 (“Enactment Date”), and has several key provisions impacting accounting for and reporting of income taxes. The most significant provision reduces the U.S. corporate statutory tax rate from 35% to 21% beginning on January 1, 2018. Although most provisions of tax reform are not effective until31, 2018, the Company is required to record the effect ofmaintained a change in tax law as of the Enactment Date on its deferred tax assets. As the Company maintains a full valuation allowance againstto fully offset its net deferred tax assets there is noprimarily attributable to operations in the United States, as the realization of such assets was not considered more likely than not.

The Company files income tax expense recorded related to this change. As ofreturns in the Enactment Date, the Company estimated that its deferred tax assetU.S. Federal and related valuation allowance were each reduced by approximately $2.2 million.various state and local jurisdictions.

 

25

In accordance with Staff Accounting Bulletin 118 (“SAB 118”), income tax effects of the Tax Act may be refined upon obtaining, preparing, or analyzing additional information during the measurement period and such changes could be material. During the measurement period, provisional amounts may be adjusted for the effects, if any, of interpretative guidance issued after December 31, 2017, by U.S. regulatory and standard-setting bodies. While we are able to make reasonable estimates of the impact of the reduction in corporate rate and the deemed repatriation transition tax, the final impact of the Tax Act may differ from these estimates, due to, among other things, changes in our interpretations and assumptions, additional guidance that may be issued by the I.R.S., and actions we may take. We are continuing to gather additional information to determine the final impact.

 

Due to the Company’s history of losses and uncertainty of future taxable income, a valuation allowance sufficient to fully offset net operating losses and other deferred tax assets has been established. The valuation allowance will be maintained until sufficient positive evidence exists to support a conclusion that a valuation allowance is not necessary. The issuance of the Series E Preferred Stock in connection with its original acquisition of the PolarityTE, Inc., a Nevada corporation in April 2017, will likely result in limitations on the utilization of the Company’s net operating loss carryforwards under IRS section 382.

POLARITYTE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

14.13. LOSS PER SHARE

 

Shares of common stock issuable under convertible preferred stock, warrants and options andThe following outstanding potentially dilutive shares subject to restricted stock grants were not included inhave been excluded from the calculation of diluted earningsnet loss per common share for the three and nine months ended July 31, 2018 and 2017, as the effect ofperiods presented due to their inclusion would be anti-dilutive.anti-dilutive effect:

  For the Three Months Ended March 31 
  2019  2018 
Shares issuable upon exercise of stock options  6,576,816   4,814,568 
Non-vested shares under restricted stock grants  516,875   199,375 

 

For periods when shares of participating preferred stock (as defined in ASC 260 earnings per share) are outstanding, the two-class method is used to calculate basic and diluted earnings (loss) per common share. The two-class method is an earnings allocation formula that determines earnings per share for each class of common stock and participating security according to dividends declared (or accumulated) and participation rights in undistributed earnings. Under the two-class method, basic earnings (loss) per common share is computed by dividing net earnings (loss) attributable to common shares after allocation of earnings to participating securities by the weighted-average number of shares of common stock outstanding during the year. Diluted earnings (loss) per common share, when applicable, is computed using the more dilutive of the two-class method or the if-converted method. In periods of net loss, no effect is given to participating securities since they do not contractually participate in the losses of the Company.

The table below provides total potential shares outstanding, including those that are anti-dilutive, on July 31, 2018 and 2017:

  July 31, 
  2018  2017 
Shares issuable upon conversion of preferred stock  -   9,020,287 
Shares issuable upon exercise of stock options  5,521,569   2,918,806 
Non-vested shares under restricted stock grants  348,031   294,363 

15.14. COMMITMENTS AND CONTINGENCIES

 

Contingencies

 

On June 26, 2018, a class action complaint alleging violations of the Federal securities laws was filed in the United States District Court, District of Utah, by Jose Moreno against the Company and two directors of the Company, Case No. 2:18-cv-00510-JNP (the “Moreno Complaint”). On July 6, 2018, a similar complaint was filed in the same court against the same defendants by Yedid Lawi, Case No. 2:18-cv-00541-PMW (the “Lawi Complaint”). Both the Moreno Complaint and Lawi Complaint allege that the defendants made or were responsible for, disseminating information to the public through reports filed with the Securities and Exchange Commission and other channels that contained material misstatements or omissions in violation of Sections 10 and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 adopted thereunder. Specifically, both complaints allege that the defendants misrepresented the status of one of the Company’s patent applications while touting the unique nature of the Company’s technology and its effectiveness. Plaintiffs are seeking damages suffered by them and the class consisting of the persons who acquired the publicly-traded securities of the Company between March 31, 2017, and June 22, 2018. Plaintiffs have filed motions to consolidate and for appointment as lead plaintiff. On November 28, 2018, the Court consolidated the Moreno and Lawi cases under the caption In re PolarityTE, Inc. Securities Litigation (the “Consolidated Securities Litigation”), and requested the appointment of the plaintiff which are pending, soin Lawi as the lead plaintiff. On January 16, 2019, the Court granted the motion of Yedid Lawi for appointment as lead plaintiff, and on February 1, 2019, the Court granted the lead plaintiff’s motion for approval of lead counsel and liaison counsel. The Court ordered that the lead plaintiff file and serve a consolidated complaint no later than 60 days after February 1, 2019, the defendants shall have not60 days after filing and service of the consolidated complaint to answer or otherwise respond, and the lead plaintiff must file a motion for class certification within 90 days of service of the consolidated complaint. The Lead Plaintiff filed any responsive pleadings toa consolidated complaint on April 2, 2019, and asserted essentially the same violations of Federal securities laws recited in the original complaints. The Company believes the allegations in the Moreno Complaint and Lawi Complaintconsolidated complaint are without merit, and intends to defend the litigation, vigorously. The Company expects its first response will be to file a motion to dismiss the consolidated complaint. At this early stage of the proceedings the Company is unable to make any prediction regarding the outcome of the litigation.

 

On February 26, 2015, a complaint for patent infringement was filed in the United States District Court for the Eastern District of Texas by Richard Baker, an individual residing in Australia, against Microsoft, Nintendo, Majesco Sub, and a number of other game publisher defendants. The complaint alleged that the Zumba Fitness Kinect game infringed plaintiff’s patents in motion tracking technology. The plaintiff is representing himself pro se in the litigation and is seeking monetary damages in the amount of $1.3 million. The case was subsequently transferred to the Western District of Washington. On June 16, 2017, final judgment was entered in favor of the defendants finding that the accused products did not literally infringe the asserted patent and that plaintiff was barred from pursing infringement under the doctrine of equivalents due to prosecution history estoppel. The plaintiff appealed that decision to the Court of Appeals for the Federal Circuit. On April 9, 2018, the Court of Appeals for the Federal Circuit affirmed the judgment of the District Court for the Western District of Washington. On May 7, 2018, the plaintiff filed a petition for panel rehearing and rehearing en banc by the Court of Appeals. The petition for rehearing was denied on June 8, 2018. The plaintiff subsequently filed a petition for a writ of certiorari with the Supreme Court of the United States. That petition was placed on the docket September 4, 2018 as No. 18-276 and is currently pending. On June 23, 2017, as part of a purchase agreement, liabilities and claims relating to this litigation were assumed by Zift. The Company cannot be certain about the outcome of the appeal, or whether litigation regarding the assumption of liabilities by Zift may occur.

POLARITYTE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

In addition to the items above, the Company at times may be a party to claims and suits in the ordinary course of business. We record a liability when it is both probablebusiness, we may become involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements, regulatory compliance, and other matters. Except as noted above, at March 31, 2019, we were not party to any legal or arbitration proceedings that a liability has been incurred and the amount of the loss or range of loss can be reasonably estimated. The Company has not recorded a liability with respect to the matter above. While the Company believes that it has valid defenses with respect to the legal matter pending and intends to vigorously defend the matter above, given the uncertainty surrounding litigation and our inability to assess the likelihood of a favorable or unfavorable outcome, it is possible that the resolution of the matter couldmay have a material adverse effectsignificant effects on our consolidated financial position cash flows or results of operations. We are not a party to any material proceedings in which any director, member of senior management or affiliate of ours is either a party adverse to us or our subsidiaries or has a material interest adverse to us or our subsidiaries.

 

Commitments

The Company leases office space in Hazlet, New Jersey at a cost of approximately $1,100 per month under a lease agreement that expires on March 31, 2019.

The Company also leased space in Salt Lake City, Utah at a cost of approximately $24,000 per month under a lease agreement that expired on March 31, 2018. The Company will continue to lease space in Salt Lake City, Utah at a cost of approximately $12,400 per month under a lease agreement that expires on September 30, 2018. The Company will exit the property at the termination of the lease.

On December 27, 2017, the Company signed a five-year lease with one five-year option to renew on approximately 178,528 rentable square feet in Salt Lake City, Utah. The base rent for the first year of the lease is $1,178,285 and escalates at the rate of 3% per annum thereafter.

On July 11, 2018, the Company signed a two-year lease with one five-year option to renew on approximately 44,695 rentable square feet in Salt Lake City, Utah. The base rent, including building maintenance fees is $478,237 per annum. As of July 31, 2018, this lease had not commenced and is expected to commence during the fiscal quarter ending October 31, 2018.

Rent expense for the three months ended July 31, 2018 and 2017 was approximately $356,000 and $87,000, respectively. Rent expense for the nine months ended July 31, 2018 and 2017 was approximately $994,000 and $147,000, respectively.

 

The Company has entered into employment agreements with key executives that contain severance terms and change of control provisions.

 

26

16. DISCONTINUED OPERATIONS

 

The results of operations from the discontinued business for the three and nine months ended July 31, 2018 and 2017 are as follows (in thousands):

  For the Three Months Ended  For the Nine Months Ended 
  July 31,  July 31, 
  2018  2017  2018  2017 
Revenues $-  $143  $-  $558 
Expenses  -   176   -   1,007 
Gain (loss) from discontinued operations $-  $(33) $-  $(449)
                 
Gain on sale of discontinued operations $-  $100  $-  $100 

POLARITYTE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

The cash flows from the discontinued business for the nine months ended July 31, 2018 and 2017 are as follows (in thousands):

  

For the nine months ended

July 31,

 
  2018  2017 
CASH FLOWS FROM OPERATING ACTIVITIES        
Net loss from discontinued operations $-  $(349)
Adjustments to reconcile net loss from discontinued operations to net cash used in discontinued operating activities:        
Depreciation and amortization  -   11 
Stock based compensation expense  -   1,118 
Amortization of capitalized software development costs and license fees  -   50 
Gain on sale of Majesco Sub      (100)
Changes in operating assets and liabilities:        
Accounts receivable  -   113 
Accounts payable and accrued expenses  -   (810)
Net cash provided by discontinued operating activities $-  $33 
         
CASH FLOWS FROM INVESTING ACTIVITIES        
Cash received from sale of Majesco Sub $45  $10 
Net cash provided by discontinued investing activities $45  $10 

17. SEGMENT REPORTING

The Company’s operations involve dissimilar products which are managed separately. Accordingly, it operates in two segments: 1) regenerative medicine and 2) veterinary sciences.

Certain information concerning our segments for the three and nine months ended July 31, 2018 and 2017 and as of July 31, 2018 and 2017 is presented in the following table (in thousands):

  Three Months Ended July 31, 
  2018  2017 
Revenues:      
Reportable Segments:        
Regenerative Medicine $244  $ 
Veterinary Sciences  172    
Discontinued Operations      
Total consolidated revenues $416  $ 
         
Net loss:        
Reportable Segments:        
Regenerative Medicine $(17,157) $(5,267
Veterinary Sciences  (88)   
Discontinued Operations     67 
Total net loss $(17,245) $(5,200)

POLARITYTE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

  Nine Months Ended July 31, 
  2018  2017 
Revenues:      
Reportable Segments:        
Regenerative Medicine $260  $ 
Veterinary Sciences  172    
Discontinued Operations      
Total consolidated revenues $432  $ 
         
Net loss:        
Reportable Segments:        
Regenerative Medicine $(42,865) $(120,872
Veterinary Sciences  (88)   
Discontinued Operations     (349)
Total net loss $(42,953) $(121,221)

  As of
July 31, 2018
  

As of

October 31, 2017

 
Identifiable assets employed:        
Reportable Segments:        
Regenerative Medicine $93,577  $20,152 
Veterinary Sciences  4,310    
Discontinued Operations      
Total assets $97,887  $20,152 

18. SUBSEQUENT EVENTS15. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS

 

ChangesIn October 2018, the Company entered into an office lease covering approximately 7,250 square feet of rental space in Boardthe building located at 40 West 57th Street in New York City. The lease is for a term of Directorsthree years. The annual lease rate is $60 per square foot. Initially the Company will occupy and Officerspay for only 3,275 square feet of space, and the Company is not obligated under the lease to pay for the remaining 3,975 square feet covered by the lease unless we elect to occupy that additional space. Comparable annual lease rates for similar office space in the area range between $67 and $110 per square foot. The Company believes the terms of the lease are very favorable to us, and the Company obtained these favorable terms through the assistance of Peter A. Cohen, a director, which he provided so that the company he owns, Peter A. Cohen, LLC (“Cohen LLC”), could sublease a portion of the office space.

 

On August 7, 2018, Edward Swanson resignedInitially, the Company is using three offices and two work stations in the office and share common areas representing approximately 2,055 square feet. Cohen LLC is using approximately 1,220 square feet. The monthly lease payment for 3,275 square feet is $16,377. Of this amount $6,103 is allocated pro rata to Cohen LLC based on square footage occupied. Additional lease charges for operating expenses and taxes are allocated under the sublease based on the ratio of rent paid by the Company and Cohen LLC to total rent.

Cohen LLC identified two associated entities that may wish to occupy an additional 2,753 square feet of space in the office. Under the terms of the sublease Cohen LLC can add this additional space to the 1,220 square feet occupied, which would bring the total space occupied by us and Cohen LLC to 6,028 square feet. Because a portion of the additional space subleased to Cohen LLC is less private and attractive, the Company agreed to reduce the overall annual lease rate for the Cohen LLC space to $58.60 per square foot, which means the Company will be paying an annual lease rate for the space the Company uses of $62.70. Assuming Cohen LLC subleases the additional office space, our annual lease payment to the lessor would be $361,680, and Cohen LLC would pay to the Company $232,830 under the sublease. During the three months ended March 31, 2019, the Company recognized $51,000 of sublease income related to this agreement. As of March 31, 2019, there was $28,000 due from the position of director of the Company, andrelated party under this agreement.

In August 2018 David Seaburg was elected by the Board of Directors of the Company (the “Board”) elected Rainer Erdtmannto serve as a director of the Company to fillCompany. Subsequently the Class III director vacancy left by the resignation of Dr. Swanson. The Board determined that Mr. Erdtmann is “independent” pursuant to the definition of independence under Rule 5605(a)(2) of the Nasdaq Listing Rules. In consideration of Mr. Erdtmann’s agreement to join the Board the Company issued to Mr. Erdtmann an option to purchase 50,000 shares of the Company’s common stock exercisable over a term of 10 years and vests in 24 equal monthly installments commencing September 7, 2018, subject to continued service on the Board. The option was issued under the Company’s 2017 Equity Incentive Plan (the “Plan”), and the exercise price is $20.47 per share, which is fair value determined under the Plan. Mr. Erdtmann will also be entitled to participate in the annual compensation package the Company provides to its non-employee directors.

On August 7, 2018, pursuant to Article II, Section 1.B of the Company’s Bylaws the Board approved an increase in the number of persons comprising the Board from seven to eight by adding one new director position to Class II of the Board, and the Board elected David Seaburg a director of the Company to fill the vacancy in Class II of the Board. The Company entered into a written consulting agreement with Mr. Seaburg pursuant to which he will provide investor relations and other services to the Company over a period of two years for a fee consisting of (a)(i) quarter-annual cash payment of $10,000, (b)(ii) 60,000 restricted stock units issued under the PlanCompany equity incentive plan that vest in four equal installments every six months during the term of the agreement subject to continued service, and (c)(iii) an annual award under the PlanCompany equity incentive plan of options exercisable over a term of 10 years to purchase common stock in number equal to the number of shares of common stock with a value of $150,000 at the time of the award based on a Black-Scholes calculation.

John Stetson The agreement terminated effective March 11, 2019, when he joined the Company as President of Corporate Development. Upon termination of the consulting agreement, Mr. Seaburg was an executive officer Company serving as the Chief Investment Officer. On September 7, 2018, theissued new awards. The new awards related to his employment of John Stetson in any capacitywere entered into concurrently with the cancellation of the original awards under his consulting agreement. The modification is accounted for by calculating the incremental value of the new award as of the modification date. The incremental value will be expensed over the new award service period while the original value will continue to be expensed over the original term. As of the date the consulting agreement terminated 15,000 restricted stock units were vested and $6,667 of cash payments were accrued. The total value of Mr. Seaburg’s consulting agreement was approximately $1.7 million, which was being recognized as expense over the 24-month consulting period. Under this consulting agreement, the Company including as Chief Investment Officer, was terminated.recognized approximately $121,000 of expense prior to the termination of the  consulting agreement during the three months ended March 31, 2019.

 

2227

16. SEGMENT REPORTING

The Company’s current operations involve products and services which are managed separately. Accordingly, it operates in two segments: 1) regenerative medicine and 2) contract services.

There was only one segment for the three months ended March 31, 2018. Certain information concerning our segments for the three months ended March 31, 2019 is presented in the following table (in thousands):

  

For the Three Months

Ended March 31,

 
  2019 
Net revenues:    
Reportable segments:    
Regenerative medicine $297 
Contract services  1,168 
Total net revenues $1,465 
     
Net (loss)/income:    
Reportable segments:    
Regenerative medicine $(25,768)
Contract services  195 
Total net loss $(25,573)

17. SUBSEQUENT EVENTS

On April 10, 2019, the Company completed an underwritten offering with Cantor Fitzgerald & Co., as underwriter, providing for the issuance and sale of 3,418,918 shares of the Company’s common stock, par value $0.001 per share, at an offering price of $8.51 per share, for net proceeds of approximately $28.7 million, after deducting offering expenses payable by the Company.

On April 22, 2019, PolarityTE MD, Inc., a subsidiary of PolarityTE, Inc., entered into a sublease agreement with Joseph M. Still Burn Centers, Inc., for 6,307 square feet of manufacturing, laboratory, and office space located at 3647 J. Dewey Grey Circle, Augusta, Georgia (the “Facility”). The initial term of the sublease for the Facility is five years commencing April 22, 2019, and the Company has an option to renew for three years after the initial term and a second option to renew for an additional two years thereafter. The annual base rental rate during the initial term is $9,986 per month, or a total of $119,833 per year, with a 3% annual increase as determined by a third-party fair market value analysis. In addition, the Company is obligated to pay (i) maintenance, repairs, replacements, and restorations to the Facility, (ii) its own utilities, and (iii) its share of operating expenses for the building based on the ratio of space leased by the Company to the total leasable square footage of the building. The Company intends to use the Facility to establish a manufacturing node for SkinTE™, with the potential to manufacture other regenerative tissue products in the Company’s pipeline.

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

 

StatementsThe following information should be read in conjunction with the consolidated financial statements and related notes thereto included in this quarterly reportQuarterly Report on Form 10-Q that are not10-Q.

In addition to historical facts constituteinformation, this report contains forward-looking statements that are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, as amended, or the “Exchange Act”. Examples of forward-looking statements include statements relating to industry prospects, our future economic performance including anticipated revenues and expenditures, results of operations or financial position, and other financial items, our business plans and objectives, including our intended product releases, and may include certain assumptions that underlie forward-looking statements. Risksinvolve risks and uncertainties that may affectcause our futureactual results levelsto differ materially from plans and results discussed in forward-looking statements. We encourage you to review the risks and uncertainties discussed in the section entitled “Forward-Looking Statements” included at the beginning of activity, performance or achievements expressedthis Quarterly Report on Form 10-Q and under Part I, Item 1A. Risk Factors of our Transition Report on Form 10-K filed with the Securities and Exchange Commission on March 18, 2019. The risks and uncertainties can cause actual results to differ significantly from those in our forward-looking statements or implied by thesein historical results and trends. We caution readers not to place undue reliance on any forward-looking statements include, among other things, those discussed in this sectionmade by us, which speak only as well as factors described in Part II, Item 1A-“Risk Factors”. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. These statements are subject to business and economic risk and reflect management’s current expectations and involve subjects that are inherently uncertain and difficult to predict. Actual events or results may differ materially. Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of these statements. We are under no duty to update any of the forward-looking statements afterdate they are made. We disclaim any obligation, except as specifically required by law and the daterules of this reportthe SEC, to conform thesepublicly update or revise any such statements to reflect any change in our expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results. References herein to “we,” “us,” and “the Company” are to PolarityTE, Inc. and its consolidated subsidiaries.results will differ from those set forth in the forward-looking statements.

 

Overview

 

PolarityTE, Inc. isWe are a commercial-stage biotechnology and regenerative biomaterials company focused on transforming the lives of patients by discovering, designing and developing a range of regenerative tissue products and biomaterials for the fields of medicine, biomedical engineering and material sciences. We operate two segments; the regenerative medicine business segment and the contract research segment.

 

On March 2,Segment Reporting

The regenerative medicine business segment over the last year has established and advanced our core “TE” program, which includes our first commercial product, SkinTE. The commercial launch of SkinTE has included the build out of commercial, manufacturing, and corporate structure to support the growth of SkinTE revenue and deployments in 2019 and beyond. This includes equipment, personnel, systems, and leased properties. Research and development continue to expand to advance the product development pipeline.

In May 2018 the Company, along with its wholly owned subsidiary, Utah CRO Services, Inc.,we acquired assets of a Nevada corporation (“Acquisition Co.”), entered into agreements with Ibex Group, L.L.C., a Utah limited liability company, and Ibex Preclinical Research, Inc., a Utah corporation (collectively, the “Seller”) for the purchase of the assets and rights to the Seller’s preclinical research and veterinary sciences business and related real estate. The business consists of a “good laboratory practices” (GLP) compliant preclinical research facility, including vivarium, operating rooms, preparation rooms, storage facilities, and surgical and imaging equipment. The real property includes two parcels in Cache County, Utah, consisting of approximately 1.75 combined gross acres of land, together with the buildings, structures, fixtures, and personal property located on the real property.

The acquisition closed on May 3, 2018.estate, which we now operate through our subsidiary, Ibex Preclinical Research, Inc. The aggregate purchase price was $3.8 million, of which $2.3 million was paid at closing and the balance satisfied by a promissory note payable to the Seller with an initial fair value of $1.22$1.2 million and contingent consideration with an initial fair value of approximately $0.3 million.

As a result, we have significant research facilities and a well-educated and skilled team of scientists and researchers that comprise the contract research segment of our business. These resources are highly beneficial to the work we are doing on our TE products and other research initiatives. We also offer research services to unrelated third parties on a contract basis, which we offer under the trademark POLARITYRD. Contract research services help us defray the costs of maintaining a first-rate research facility and allow us to meet companies pursuing new technologies that may be opportunities for collaborative or strategic relationships going forward.

 

Research and Development Expenses. Research and development expenses primarily represent employee related costs, including stock compensation, for research and development executives and staff, lab and office expenses and other overhead charges.

 

General and Administrative Expenses. General and administrative expenses primarily represent employee related costs, including stock compensation, for corporate executive and support staff, general office expenses, professional fees and various other overhead charges. Professional fees, including legal and accounting expenses, typically represent one of the largest components of our general and administrative expenses. These fees are partially attributable to our required activities as a publicly traded company, such as SEC filings with the Securities and Exchange Commission (SEC), and corporate- and business-development initiatives.

 

Income Taxes. Income taxes consist of our provisions for income taxes, as affected by our net operating loss carryforwards. Future utilization of our net operating loss, or NOL, carryforwards may be subject to a substantial annual limitation due to the “change in ownership” provisions of the Internal Revenue Code. The annual limitation may result in the expiration of NOL carryforwards before utilization. Due to our history of losses, a valuation allowance sufficient to fully offset our NOL and other deferred tax assets has been established under current accounting pronouncements, and this valuation allowance will be maintained unless sufficient positive evidence develops to support its reversal.

 

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Critical Accounting Estimates

 

Our discussion and analysis of the financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP.

 

The preparation of these condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires usmanagement to make estimates and judgmentsassumptions that affect the reported amounts of assets and liabilities or the disclosure of gain or loss contingencies at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Among the more significant estimates included in these financial statements are the valuation of warrant liability, valuation of derivative liability, stock-based compensation, the valuation allowances for deferred tax benefits, and related disclosurethe valuation of contingenttangible and intangible assets and liabilities. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.included in acquisitions. Actual results could differ materially from these estimates under different assumptions or conditions.those estimates.

We have identified the policies below as critical to our business operations and to the understanding of our financial results. The impact and any associated risks related to these policies on our business operations is discussed throughout management’s discussion and analysis of financial condition and results of operations when such policies affect our reported and expected financial results.

 

AccountingGoodwill and Intangible Assets.Goodwill represents the excess acquisition cost over the fair value of net tangible and intangible assets acquired. Goodwill is not amortized and is subject to annual impairment testing or between annual tests if an event or change in circumstance occurs that would more likely than not reduce the fair value of a reporting unit below its carrying value. In testing for Stock-Based Compensation. Stock-based compensation expensegoodwill impairment, the Company has the option to first assess qualitative factors to determine whether the existence of events or circumstances lead to a determination that it is measuredmore likely than not that the fair value of a reporting unit is less than its carrying amount. If, after assessing the totality of events and circumstances, the Company concludes that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, then performing the two-step impairment test is not required. If the Company concludes otherwise, the first step of the two-step process must be performed. The goodwill impairment test is performed at the grantreporting unit level by comparing the estimated fair value of a reporting unit with its respective carrying value. If the estimated fair value exceeds the carrying value, goodwill at the reporting unit level is not impaired and the second step of the impairment test in unnecessary. If the estimated fair value is less than carrying value, the second step of the impairment test must be performed. The second step of the goodwill impairment test would be to record an impairment charge, if any, based on the excess of a reporting unit’s carrying amount over its fair value.

The fair value of reporting units is based on widely accepted valuation techniques that the Company believes market participants would use, although the valuation process requires significant judgment and often involves the use of significant estimates and assumptions. The Company utilizes a market cap approach in estimating the fair value of reporting units. The estimates and assumptions used in determining fair value could have a significant effect on whether or not an impairment charge is recorded and the magnitude of such a charge. Adverse market or economic events could result in impairment charges in future periods.

Intangible assets deemed to have finite lives are amortized on a straight-line basis over their estimated useful lives, which generally range from one to eleven years. The useful life is the period over which the asset is expected to contribute directly, or indirectly, to its future cash flows. Intangible assets are reviewed for impairment when certain events or circumstances exist. For amortizable intangible assets, impairment exists when the undiscounted cash flows exceed its carrying value. At least annually, the remaining useful life is evaluated.

Impairment of Long-Lived Assets.The Company reviews long-lived assets, including property and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends, and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset over its fair value, determined based on discounted cash flows. No impairment loss has been recognized.

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Income Taxes. The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company evaluates the potential for realization of deferred tax assets at each quarterly balance sheet date and records a valuation allowance for assets for which realization is not more likely than not.

Stock Based Compensation. The Company measures all stock-based compensation using a fair value method and records such expense in research and development, general and administrative and sales and marketing expenses. Compensation expense for stock options with cliff vesting is recognized on a straight-line basis over the vesting period of the award, based on the fair value of the award and is recognized asoption on the date of grant. For stock options with graded vesting, the Company recognizes compensation expense over the service period for each separately vesting period. Determiningtranche of the award as though the award were in substance, multiple awards.

The fair value for options issued is estimated at the date of grant using a Black-Scholes option-pricing model. The risk-free rate is derived from the U.S. Treasury yield curve in effect at the time of the grant. The volatility factor is determined based on the Company’s historical stock prices. Forfeitures are recognized as they occur.

The value of restricted stock grants is measured based on the fair market value of stock-based awardsthe Company’s common stock on the date of grant and amortized over the vesting period of, generally, six months to three years.

Revenue Recognition. In the regenerative medicine products segment, the Company records product revenues primarily from the sale of its regenerative tissue products. The Company sells its products to healthcare providers, primarily through direct sales representatives. Product revenues consist of a single performance obligation that the Company satisfies at a point in time. In general, the grantCompany recognizes product revenue upon delivery to the customer. In the contract services segment, the Company earns service revenues from the provision of contract research services, which includes delivery of preclinical studies and other research services to unrelated third parties. Service revenues generally consist of a single performance obligation that the Company satisfies over time using an input method based on costs incurred to date requires judgment, including, inrelative to the case of stock option awards, estimatingtotal costs expected stock volatility.to be required to satisfy the performance obligation.

 

AccountingLeases.On January 1, 2019 the Company adopted ASU 2016-02,Leases (ASC 842) and related amendments, which require lease assets and liabilities to be recorded on the balance sheet for Common and Preferred Stock and Warrant transactions. We issued units consistingleases with terms greater than twelve months. The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of preferred shares and warrants and common stock and warrants and subsequently remeasured certain of those warrants. Determiningwhether or not the fair valuelease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the securitieslease, respectively. The standard was adopted using the modified retrospective transition approach by applying the new standard to all leases existing at the date of the initial application and not restating comparative periods. The most significant impact was the recognition of ROU assets and lease liabilities for operating leases, while our accounting for finance leases remained substantially unchanged. See Note 2 – Summary of Significant Accounting Policies and Note 7 – Leases in these transactions requires significant judgment, including adjustmentsthe notes to quoted share prices and expected stock volatility. Such estimates may significantly impact our resultsthe condensed consolidated financial statements included in Part I, Item 1, of operations and losses applicable to common stockholders.this Quarterly Report on Form 10-Q for additional information regarding the adoption.

 

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Commitments and Contingencies. We record a liability for contingencies when the amount is both probable and reasonably estimable. We record associated legal fees as incurred.

 

Results of Operations

 

Three months ended JulyMarch 31, 20182019 versus three months ended JulyMarch 31, 20172018

 

Net Revenues.Revenues. For the three-month period ended JulyMarch 31, 2018,2019, total net revenues were $1.465 million including net revenues from productproducts sales were $0.4 million, which represents approximately $0.2of $0.3 million from the sale of the Company’s core product SkinTE and approximately $0.2in the regenerative medicine business segment. Regenerative medicine revenues for the three-month period ended March 31, 2018 were $0.003 million. Net revenues from services sales were $1.168 million from the contract research segment operations driven primarily by the Ibex preclinical research business, which was acquired in Veterinary Sciences.the second quarter of 2018 and, therefore, not a contributor to revenue in the first quarter of 2018.

 

Cost of Sales.Sales. For the three-month period ended JulyMarch 31, 2018,2019, cost of sales was approximately $0.2 million and approximately 55% of net revenues.

Research and Development Expenses. For the three-month period ended July 31, 2018, research and development expenses were approximately $2.3 million, mostly consisting of stock-based compensation of approximately $1.2 million, salaries of approximately $0.5 million and depreciation of approximately $0.3 million. For the three-month period ended July 31, 2017, research and development expenses were approximately $1.6 million and mostly consisted of salaries of approximately $0.5 million, stock-based compensation of approximately of $0.5 million, travel relates expenses of approximately $0.3 million and depreciation of approximately $0.1 million.

General and Administrative Expenses. For the three-month period ended July 31, 2018, general and administrative expenses were approximately $15.2 million compared to $3.6 million for the three months ended July 31, 2017. The increase is primarily due to an increase of approximately $6.3 million in stock-based compensation, $0.6 million in legal and accounting and $0.6 million in consulting expenses.

Other (Expenses) Income. For the three-month period ended July 31, 2018, other (expenses) income mainly included an interest income of approximately $0.1 million. For the three-month period ended July 31, 2017, other (expenses) income was insignificant.

Net Loss from continuing operations. Net loss from continuing operations for the three months ended July 31, 2018 was approximately $17.2 million, compared to a loss of approximately $5.3 million in the comparable period in 2017, primarily reflecting the increase in stock-based compensation and other product research and development and general and administrative expenses.

Nine months ended July 31, 2018 versus nine months ended July 31, 2017

Net Revenues. For the nine-month period ended July 31, 2018, net revenues from product sales were $0.4 million, which represents approximately $0.2 million from the sale of the Company’s core product SkinTE and approximately $0.2 million from contract research operations in Veterinary Sciences.

Cost of Sales. For the nine-month period ended July 31, 2018, cost of sales was approximately $0.2$0.776 million and approximately 53% of net revenues. Products cost of sales were $0.273 million or 92% of products sales due to fixed overhead costs. Services cost of sales were $0.503 million or 43% of service sales. Regenerative medicine cost of sales for the three-month period ended March 31, 2018 were $0.001 million.

 

Research and Development Expenses. For the nine-month period ended July 31, 2018, research and development expenses were approximately $14.6 million.Expenses. Research and development expenses mostly consist of stock-based compensation of approximately $4.9 million, salaries of approximately $4.1 million, medical studies of approximately $0.5 million, bonuses of approximately $0.5 million, medical samples of approximately $0.5 million, depreciation of approximately $0.9 million, rent of approximately $0.7 million, office expense of approximately $0.5 million, business meals and transportation of approximately $0.3 million, consulting of approximatelydecreased $0.2 million, and health insurance of approximately $0.2 million. Foror 4%, in the nine-monththree-month period ended JulyMarch 31, 2017,2019, compared to the three-month period ended March 31, 2018. The decrease is primarily driven by a shift in mix between commercial and operational infrastructure build out in the current period as well as research and development expenses were approximately $3.4 million and mostly consist of salaries of approximately $1.3 million, stock-based compensation of approximately of $0.6 million, travel relates expenses of approximately $0.5 million and depreciation of approximately $0.3 million.costs in the prior period.

General and Administrative Expenses.Expenses. General and administrative expenses increased $9.6 million, or 127%, in the three-month period ended March 31, 2019 compared to the three-month period ended March 31, 2018. The Company expanded its infrastructure to support the commercial launch of SkinTE. The resulting increase in expenses is driven primarily by employee-related costs, including stock-based compensation, salaries, and benefits, and increased outside services expense, including legal and accounting fees and consulting expenses.

Sales and Marketing Expenses. For the three-month period ended March 31, 2019, sales and marketing expenses were $4.0 million. This represents sales personnel and marketing costs primarily driven by the initial regional release of SkinTE. There were no sales personnel and marketing costs during the three-month period ended March 31, 2018.

Other Income (Expenses). For the nine-monththree-month period ended JulyMarch 31, 2018, general and administrative expenses were approximately $32.12019, other income (expenses) decreased $1.1 million or 83% compared to $12.8 million for the nine months ended July 31, 2017. The increase is primarily due to an increase of $12.7 million in stock-based compensation, $1.1 million in legal and accounting and $1.0 million in consulting expenses.

Other (Expenses) Income. For the nine-monththree-month period ended JulyMarch 31, 2018, other (expenses) income mainly included2018. This decrease was primarily driven by a change in the fair value of derivatives of approximately a $3.8$1.9 million gain and arecorded, offset by loss on extinguishment of warrant liability of approximately $0.5 million. Formillion in the nine-monththree months ended March 31, 2018. There were no warrants outstanding for the three-month period ended JulyMarch 31, 2017, other (expenses) income was insignificant.2019.

 

Net loss from continuing operations.. Net loss from continuing operations for the nine monthsthree-month period ended JulyMarch 31, 20182019 was approximately $43.0$25.6 million compared to a net loss of approximately $120.9$11.8 million infor the comparablethree-month period in 2017,ended March 31, 2018, primarily reflecting the decrease of $104.7 million in research and development - intellectual property acquired expenses offset by the increase in stock-based compensation.sales and operating expenses driven by expanding operations discussed above.

 

Liquidity and Capital Resources

 

As of JulyMarch 31, 2018,2019, our cash, and cash equivalents and short-term investments balance was approximately $84.8$44.7 million and our working capital was approximately $81.5$39.1 million, compared to cash and cash equivalents and short term investments of $17.7$61.8 million and working capital of $2.5$56.8 million at OctoberDecember 31, 2017.2018.

 

As reflected in the condensed consolidated financial statements, we had an accumulated deficit of approximately $302.0$368.4 million at JulyMarch 31, 2018, a net loss of approximately $43.0 million2019, and approximately $17.0$16.6 million net cash used in continuing operating activities for the nine monthsthree-month period then ended. At December 31, 2018, we had an accumulated deficit of approximately $342.9 million and approximately $3.9 million net cash used in operating activities for the three-months ended JulyMarch 31, 2018.

 

On April 12, 2018, we completed a public offering providing for the issuance and sale of 2,335,937 shares of our common stock par value $0.001 per shares at an offering price of $16.00 per share, forresulting in net proceeds of $34.6 million, after deducting offering expenses payable by us.

expenses. On June 7, 2018, we completed an underwritten offering of 2,455,882 shares of our common stock at an offering price of $23.65 per share, resulting in net proceeds of approximately $58.0 million, after deducting offering expenses. On April 10, 2019, the Company completed an underwritten offering with Cantor Fitzgerald & Co., as underwriter, providing for the issuance and sale of 2,455,8823,418,918 shares of ourthe Company’s common stock, par value $0.001 per share, at an offering price of $23.65$8.51 per share, for net proceeds of approximately $58.0$28.7 million, after deducting offering expenses payable by us.the Company.

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Based upon the current status of our product development and commercialization plans, we believe that our existing cash, and cash equivalents and short-term investments will be adequate to satisfy our capital needs for at least the next 12 months from the date of filing. We anticipate needing substantialNevertheless, it is likely in the future we may need additional financing to continue clinical deployment and commercialization of our lead product SkinTE,TE products, development of our other product candidates, and scaling the manufacturing capacity for our products and product candidates, and prepare for commercial readiness. Wecandidates. Accordingly, we will continue to pursue fundraising opportunities when available, however, such financing may not be available on terms favorable to us, if at all. If adequate funds are not available in the future, we may be required to delay, reduce the scope of, or eliminate one or more of our productoperational or development programs. We plan to meet our future capital requirements primarily through issuances of equity securities, debt financing, revenue from product sales and future collaborations. Failure to generate revenue or raise additional capital as needed in the future would adversely affect our ability to achieve our intended business objectives.

 

Our actual capital requirements will depend on many factors, including among other things: our ability to scale the manufacturing for and to commercialize successfully our lead product, SkinTE; the progress and success of clinical evaluation and acceptance of SkinTE; our ability to develop our other product candidates; and the costs and timing of obtaining any required regulatory registrations or approvals. Our forecast ofstatements regarding the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. The foregoing factors, along with the other factors described in the section,Part I, Item 1A, “Risk Factors” in Part II1A. Risk Factors of this Report on Form 10-Q as well as our risk factors set forth in our AnnualTransition Report on Form 10-K forfiled with the year ended October 31, 2017,SEC on March 18, 2019 will impact our future capital requirements and the adequacy of our available funds. If we are required to raise additional funds, any additional equity financing may be highly dilutive, or otherwise disadvantageous, to existing stockholders, and debt financing, if available, may involve restrictive covenants. CollaborativeIf we elect to pursue collaborative arrangements, if necessary to raise additional funds,the terms of such arrangements may require us to relinquish rights to certain of our technologies, products or marketing territories. Our failure to raise capital when needed, and on acceptable terms, would require us to reduce our operating expenses and would limit our ability to respond to competitive pressures or unanticipated requirements to develop our product candidates and to continue operations, any of which would have a material adverse effect on our business, financial condition and results of operation.

 

As previously reported, we identified a material weakness in the effectiveness of our internal controls over financial reporting, a factor that could affect our liquidity and capital resources. At present, management believes that the recent improvement of the processes for granting equity awards to certain employees and service providers will ultimately correct the material weakness.

Common Stock

During the nine months ended July 31, 2018, certain employees exercised their options at a weighted-average exercise price of $3.87 in exchange for the Company’s common stock for an aggregated amount of 30,417 shares.

Off-Balance Sheet Arrangements

 

As of JulyMarch 31, 2018,2019, we had no off-balance sheet arrangements.

 

Inflation

 

Our management currently believes that inflation has not had, and does not currently have, a material impact on continuing operations.

 

Cash Flows

 

Cash, and cash equivalents and working capitalshort-term investments were approximately $84.8$44.7 million and $81.5 million, respectively, as of JulyMarch 31, 20182019, compared to cash and cash equivalents and short term investments of approximately $61.8 million as of December 31, 2018. Working capital was approximately $39.1 million as of March 31, 2019, compared to working capital of approximately $17.7$56.8 million and $2.5 million at Octoberas of December 31, 2017, respectively.2018.

 

Operating Cash Flows.Flows

Cash used in continuing operating activities in the nine months ended July 31, 2018 amounted to approximately $17.0 million compared to approximately $4.7 million for the 2017 period.three-month period ended March 31, 2019, was approximately $16.6 million. Approximately $3.9 million of cash was used in operating activities for the three-month period ended March 31, 2018. The increase in net cash used in continuing operating activities mostly relates to the increases in both researchexpansion of infrastructure and developmentsales and general and administrative expenses.marketing expenses related to the commercial launch of SkinTE.

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Investing Cash Flows

 

Cash used in discontinued operatinginvesting activities in the nine months ended July 31, 2018 amounted to $0 compared to approximately $33,000 for the samethree-month period in 2017.

Investing Cash Flows.ended March 31, 2019, was approximately $5.1 million. Cash used in continuing investing activities infor the nine monthsthree-month period ended JulyMarch 31, 2018 amounted to approximately $8.7 million compared to $2.3 million for the 2017 period.$3.0 million. For the nine monthsthree-month period ended JulyMarch 31, 2018,2019, the activity relates to the acquisitionnet purchase of IBEXavailable-for-sale securities and the purchase of property and equipment. For the nine monthsthree-month period ended JulyMarch 31, 2017,2018, the activity only relates to the purchase of property and equipment.

 

Financing Cash Flows.

Net cash provided by financing activities for the nine monthsthree-month period ended JulyMarch 31, 2018 amounted to2019, was approximately $92.8 million compared to approximately $3.4 million$0.9 million. There was no cash provided by or used in financing activities for the 2017 period. The $92.7 million in netthree-month period ended March 31, 2018. For the three-month period ended March 31, 2019, the activity relates to proceeds from the sale of common stock in the nine months ended July 31, 2018, accounts for the majority of that period’s financing activityoptions exercised offset by principal payments on finance leases and accounts for the majority of the increase in net cash proved by financing activities as compared to the comparable prior year period.contingent consideration liability payments.

 

Recent Accounting Pronouncements

 

Refer to our discussion of recent accounting pronouncements in Note 2 - Summary of Significant Accounting Policies to the accompanying condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

 

Item 3. Quantitative and Qualitative Disclosure about Market Risk

 

Not applicable.

 

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures.

We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to ensure that information required to be disclosed in our 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 that such information is accumulated and communicated to our management, including our principal executive officer and principal financial and accounting officer, as appropriate, to allow timely decisions regarding required disclosure.

 

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as defined in the Securities Exchange Act of 1934 Rule 13a-15(e) and 15d-15(e), as of the end of the period covered by this report. In designing and evaluating our disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives.

A material weakness is a deficiency, or a combination of deficiencies, within the meaning of Public Company Accounting Oversight Board (“PCOAB”) Audit Standard No. 5, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis.

Under the caption “Item 4. Controls and Procedures” of our report on Form 10-Q for the quarter ended January 31, 2018, filed with the Securities and Exchange Commission on March 19, 2018, we reported a material weakness in our internal control over financial reporting. Specifically, due to a lack of processes in place to address personnel changes, controls over the Company’s process of accounting for stock-based compensation failed to ensure the completeness of stock options and restricted stock grants in the Company’s calculation of stock-based compensation expense. In addition, due to a lack of adequate review and reconciliation control procedures, the Company’s internal control over financial reporting failed to prevent adjustments to the Company’s financial statements in the quarter ended January 31, 2018, with respect to certain costs not material in amount that we expensed, which should have been capitalized and classified as fixed assets.

During the quarter ended January 31, 2018, we started the process to mitigate the material weakness in our process of accounting for stock-based compensation, and we expect it to be remediated during fiscal year 2018. At the end of April 2018, we engaged the services of a third party accounting advisory firm to provide assistance in developing more effective processes and controls in recording and classifying expenditures, and reviewing and making appropriate period-end adjustments.

Based on the evaluation of the effectiveness of our disclosure controls and procedures and the material weaknesses identified above that have not yet been remediated,as of March 31, 2019, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, were not effective due to the material weaknesses in our internal control over financial reporting identified below. To address the material weaknesses, management performed additional analyses and other procedures to determine whether the financial statements included herein fairly present our financial results. Subject to the limitations above, management believes that the consolidated financial statements and other financial information contained in this report, fairly present in all material respects our financial condition, results of operations, and cash flows for the periods presented.

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. Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles in the United States of America, or GAAP. Our management does not expect that our disclosure controls and procedures (as definedor our internal controls will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in Exchange Act Rules 13a-15(e)all control systems, no evaluation of controls can provide absolute assurance that all control issues and 15d-15(e)) were not effective atinstances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a reasonable assurance level at Julysimple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control.

On January 1, 2019, the Company adopted Accounting Standards Codification Topic 842, Leases, and implemented appropriate changes to its internal controls to support the changes in required reporting, including updated procedures related to lease accounting and contract review controls and added documentation processes related to accounting for the new standard. 

There have been no other changes in the Company’s internal control over financial reporting during the quarter ended March 31, 2018.2019 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

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Two material weaknesses previously identified as of December 31, 2018, continued to exist as of March 31, 2019, which include (1) insufficient internal controls related to information technology general controls in the areas of user access and user provisioning, over certain systems that support the financial reporting process; and (2) ineffective controls related to the documentation and completeness of the Company’s stock-based compensation expense.

 

Changes in Internal Control Overover Financial Reporting

 

AtWe have taken several steps to remediate the end of April 2018,material weaknesses identified above. These steps include the following:

Stock-Based Compensation System – The Company is in the process of implementing a systemic solution to our stock-based compensation accounting, including internal processes and an external compensation account management tool. The tool was launched during the first quarter of 2019. The system implementation and additional procedures enable the Company to properly document the stock-based compensation expense. The Company expects this issue to be remediated during 2019 after adequate test sampling to evaluate operating effectiveness.
IT Systems & Controls – The Company has hired additional IT personnel and adopted access restrictions and protocols to prevent unauthorized access and unauthorized changes to data and records. We are evaluating these changes and whether they address the system control issues

As we obtained from a third-party accounting advisory firm assistance in developing more effective processescontinue to evaluate and controls in recording and classifying expenditures, and reviewing and making appropriate period-end adjustments. In addition, we implemented a phased approach of a company-wide enterprise resource planning system during the quarter ended July 31, 2018,work to further enhanceimprove our internal control environment. To effectuate these systems we added threeover financial reporting, management may determine to take additional peoplemeasures to our accounting staff beginning in April 2018.Weaddress the material weaknesses or determine to modify the remediation plan described above. Until the remediation steps set forth above are fully implemented and operating for a sufficient period of time, the material weakness described above will continue to monitor the impact of this implementation on our processes as well as the impact to the internal controls over financial reporting.exist.

 

PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

 

There have been no material changes to legal proceedings for the period ended March 31, 2019 except as noted below.

Shareholder Litigation

On June 26, 2018, a class action complaint alleging violations of the Federal securities laws was filed in the United States District Court, District of Utah, by Jose Moreno against the Company and two directors of the Company, Case No. 2:18-cv-00510-JNP (the “Moreno Complaint”). On July 6, 2018, a similar complaint was filed in the same court against the same defendants by Yedid Lawi, Case No. 2:18-cv-00541-PMW (the “Lawi Complaint”). Both the Moreno Complaint and Lawi Complaint allege that the defendants made or were responsible for, disseminating information to the public through reports filed with the Securities and Exchange Commission and other channels that contained material misstatements or omissions in violation of Sections 10 and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 adopted thereunder. Specifically, both complaints allege that the defendants misrepresented the status of one of the Company’s patent applications while touting the unique nature of the Company’s technology and its effectiveness. Plaintiffs are seeking damages suffered by them and the class consisting of the persons who acquired the publicly-traded securities of the Company between March 31, 2017, and June 22, 2018. Plaintiffs have filed motions to consolidate and for appointment as lead plaintiff. On November 28, 2018, the Court consolidated theMoreno andLawi cases under the captionIn re PolarityTE, Inc. Securities Litigation(the “Consolidated Securities Litigation”), and requested the appointment of the plaintiff which are pending, soinLawi as the lead plaintiff. On January 16, 2019, the Court granted the motion of Yedid Lawi for appointment as lead plaintiff, and on February 1, 2019, the Court granted the lead plaintiff’s motion for approval of lead counsel and liaison counsel. The Court ordered that the lead plaintiff file and serve a consolidated complaint no later than 60 days after February 1, 2019, the defendants shall have not60 days after filing and service of the consolidated complaint to answer or otherwise respond, and the lead plaintiff must file a motion for class certification within 90 days of service of the consolidated complaint. The Lead Plaintiff filed any responsive pleadings toa consolidated complaint on Aril 2, 2019, and asserted essentially the same violations of Federal securities laws recited in the original complaints. The Company believes the allegations in the Moreno Complaint and Lawi Complaintconsolidated complaint are without merit, and intends to defend the litigation, vigorously. The Company expects its first response will be to file a motion to dismiss the consolidated complaint. At this early stage of the proceedings the Company is unable to make any prediction regarding the outcome of the litigation.

On February 26, 2015, a complaint for patent infringement was filed in the United States District Court for the Eastern District of Texas by Richard Baker, an individual residing in Australia, against Microsoft, Nintendo, Majesco Sub, and a number of other game publisher defendants. The complaint alleged that the Zumba Fitness Kinect game infringed plaintiff’s patents in motion tracking technology. The plaintiff is representing himself pro se in the litigation and is seeking monetary damages in the amount of $1.3 million. The case was subsequently transferred to the Western District of Washington. On June 16, 2017, final judgment was entered in favor of the defendants finding that the accused products did not literally infringe the asserted patent and that plaintiff was barred from pursing infringement under the doctrine of equivalents due to prosecution history estoppel. The plaintiff appealed that decision to the Court of Appeals for the Federal Circuit. On April 9, 2018, the Court of Appeals for the Federal Circuit affirmed the judgment of the District Court for the Western District of Washington. On May 7, 2018, the plaintiff filed a petition for panel rehearing and rehearing en banc by the Court of Appeals. The petition for rehearing was denied on June 8, 2018. The plaintiff subsequently filed a petition for a writ of certiorari with the Supreme Court of the United States. That petition was placed on the docket September 4, 2018 as No. 18-276 and is currently pending. On June 23, 2017, as part of a purchase agreement, liabilities and claims relating to this litigation were assumed by Zift. The Company cannot be certain about the outcome of the appeal, or whether litigation regarding the assumption of liabilities by Zift may occur.

The Company at times may be a party to claims and suits in the ordinary course of business. We record a liability when it is both probable that a liability has been incurred and the amount of the loss or range of loss can be reasonably estimated. The Company has not recorded a liability with respect to the matters above. Given the uncertainty surrounding litigation and our inability to assess the likelihood of a favorable or unfavorable outcome, it is possible that the resolution of either or both matters could have a material adverse effect on our consolidated financial position, cash flows or results of operations.

Item 1A. Risk Factors

The following updates certain risk factors set forth in our Annual Report on Form 10-K, for the year ended October 31, 2017, as amended and restated in our Quarterly Reports on Form 10-Q for the period ended January 31, 2018, filed with the Securities and Exchange Commission (SEC) on March 19, 2018, and for the period ended April 30, 2018, filed with the SEC on June 14, 2018, and should be read in conjunction with the risk factors presented in those reports under the caption “Risk Factors.”

We have a history of operating losses and may never achieve or sustain profitability.

We have to date incurred, and may continue to incur, significant operating losses over the next several years. We have incurred significant net losses in each year since our inceptions, and have a net loss of $130.8 million for the year ended October 31, 2017, and $43.0 million for the nine months ended July 31, 2018. Our ability to achieve profitable operations in the future will depend in large part upon the successful development and commercialization of our product candidates and technologies. Factors impacting our ability to successfully develop and commercialize our product candidates include:

approvals by and/or registrations with the FDA and other US and foreign government agencies;
our ability to educate and train physicians and hospitals on the benefits of our product candidates;
the rate at which providers adopt our technology and product candidates;
our ability to scale up our global commercialization, including our selling and manufacturing activities;
our ability to complete the development of our product candidates in a timely manner;
our ability to obtain adequate reimbursement from third parties for our products and product candidates; and
other activities generally necessary in order to introduce and bring new products and medical technologies to market.

The likelihood of the long-term success of our company must be considered in light of the expenses, difficulties and delays frequently encountered in the development and commercialization of new and innovative medical techniques and technologies, unknown and uncertain regulatory hurdles for a new and novel technology or technique, competitive factors and competition, as well as the uncertain nature of new business development and ongoing capital requirements.

If we are not able to integrate acquisitions successfully, our operating results and prospects could be harmed.

In May 2018, we acquired from the Ibex Group, L.L.C., and Ibex Preclinical Research, Inc., certain assets and rights to their preclinical research and veterinary sciences business and related real estate. We will continue to look for opportunities to acquire technologies or operations that we believe will contribute to our growth and development. The success of our present and future acquisitions will depend on our ability to identify, negotiate, complete and integrate acquisitions. Acquisitions are inherently risky, and any acquisitions we complete may not be successful. Any acquisitions we pursue would involve numerous risks, including the following:

difficulties in integrating and managing the operations and technologies of the businesses we acquire;
diversion of our management’s attention from normal daily operations of our business;
our inability to maintain the customers, the key employees, the key business relationships and the reputations of the businesses we acquire;
our inability to generate sufficient revenue from acquisitions to offset our increased expenses associated with acquisitions;
our responsibility for the liabilities of the businesses we acquire, including, without limitation, liabilities arising out of their failure to maintain effective data security, data integrity, disaster recovery and privacy controls prior to the acquisition, or their infringement or alleged infringement of third party intellectual property, contract or data access rights prior to the acquisition;
difficulties in complying with new markets or regulatory standards to which we were not previously subject;
delays in our ability to implement internal standards, controls, procedures and policies in the businesses we acquire; and
adverse effects of acquisition activity on the key performance indicators we use to monitor our performance as a business.

Unanticipated events and circumstances may occur in future periods which may affect the realizability of our intangibles assets recognized through acquisitions. The events and circumstances that we consider include significant under-performance relative to projected future operating results and significant changes in our overall business and/or product strategies. These events and circumstances may cause us to revise our estimates and assumptions used in analyzing the value of our other intangible assets with indefinite lives, the revision could result in a non-cash impairment charge that could have a material impact on our financial results.

If we fail to maintain proper and effective internal control over financial reporting in the future, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results.

We identified certain material weaknesses in our internal control over financial reporting that were reported in our quarterly report on Form 10-Q for the quarter ended January 31, 2018. Specifically, due to a lack of processes in place to address personnel changes, controls over our process of accounting for stock-based compensation failed to ensure the completeness of stock options and restricted stock grants in our calculation of stock-based compensation expense. In addition, due to a lack of adequate review and reconciliation control procedures, our internal control over financial reporting failed to prevent adjustments to our financial statements in the quarter ended January 31, 2018, with respect to certain costs not material in amount that we expensed, which should have been capitalized and classified as fixed assets. We have taken steps to remediate these material weaknesses and we expect them to be remediated during fiscal year 2018. At the end of April 2018, we obtained from a third-party accounting advisory firm assistance in developing more effective processes and controls in recording and classifying expenditures, and reviewing and making appropriate period-end adjustments. In addition, we implemented a phased approach of a company-wide enterprise resource planning system during the quarter ended July 31, 2018, and added three additional people to our accounting staff to further enhance our internal control environment. Nevertheless, by the end of the current fiscal year these changes may not be in operation long enough for us to adequately test and evaluate whether the processes and controls we have added are effective period over period. If our remedial measures prove to be insufficient to address the material weakness, or if we otherwise fail to establish and maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results, timely file our periodic reports, maintain our reporting status or prevent fraud, any of which could adversely affect our business and operating results, investor confidence in our reported financial information, and the trading price of our common stock.

As of October 31, 2018, we will be an “accelerated filer” and are therefore subject to the auditor attestation requirement in the assessment of our internal control over financial reporting.

Because the worldwide market value of our common stock held by non-affiliates exceeded $75 million (but was less than $700 million), as of the last business day of our fiscal quarter ended April 30, 2018, we are an “accelerated filer” as defined by SEC rule as of October 31, 2018. Therefore, we are now subject to the requirement that we include in our annual report on Form 10-K for the fiscal year ending October 31, 2018, the auditor’s attestation report on its assessment of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act. We identified certain material weaknesses in our internal control over financial reporting that were reported in our quarterly report on Form 10-Q for the quarter ended January 31, 2018, and are described in the preceding risk factor. If we do not have a sufficient history for us and our independent registered public accounting firm to test and evaluate our new processes and controls, we may be unable to obtain an unqualified attestation report from our independent registered public accounting firm required under Section 404 of the Sarbanes-Oxley Act. If our independent registered public accounting firm is not able to render an unqualified attestation, it could result in lost investor confidence in the accuracy, reliability, and completeness of our financial reports. We expect that our status as an accelerated filer and compliance with these increased requirements will require management to expend additional time while also condensing the time frame available to comply with certain requirements, which may further increase our legal and financial compliance costs.

Our October 31, 2017 financial statements were prepared on a going concern basis.

In its report dated January 29, 2018, related to our October 31, 2017 consolidated financial statements, EisnerAmper LLP, our independent registered public accounting firm, expressed substantial doubt about our ability to continue as a going concern as we had suffered recurring losses from operations and had insufficient liquidity to fund our future operations.

On June 7, 2018, the Company completed an underwritten offering with Cantor Fitzgerald & Co., as underwriter, providing for the issuance and sale of 2,455,882 shares of the Company’s common stock, par value $0.001 per share, at an offering price of $23.65 per share, for net proceeds of approximately $58.0 million, after deducting offering expenses payable by the Company. As a result, as of July 31, 2018, we had $84.8 million in cash. We anticipate that our principal sources of liquidity will be sufficient to fund our activities through for at least the next 12 months from the date of filing.

Nevertheless, we anticipate we will need additional cash in order to have sufficient cash to fund our operations in future periods, and we will need to continue to raise additional equity or debt capital and we cannot provide any assurance that we will be successful in doing so.

We may not be able to raise the required capital to conduct our operations and develop and commercialize our product candidates.

We incurred net losses of $130.8 million in fiscal 2017, and additional net losses of $43.0 for the nine months ended July 31, 2018. We will require substantial additional capital resources in order to complete our product development programs, complete clinical trials, and market and commercialize our product candidates. In order to grow and expand our business, and to introduce our new product candidates into the marketplace, we will need to raise a significant amount of additional funds. We will also need significant additional funds or a collaborative partner, or both, to finance the research and development activities. Accordingly, we are continuing to pursue additional sources of financing.

Our future capital requirements will depend on numerous factors, including:

our ability to generate future revenues;
costs and timing of our product development activities;
timing of conducting pre-clinical and clinical trials and seeking regulatory approvals and/or registrations;
our ability to commercialize our product candidates;
our ability to avoid infringement and misappropriation of third-party intellectual property;
our ability to obtain valid and enforceable patents;
competing technological and market developments;
our ability to establish collaborative relationships;
market acceptance of our product candidates;
the development of an infrastructure to support or business;
our need to remediate material weaknesses and implement and maintain additional internal systems, processes and infrastructure, to have an effective system of internal control over financial reporting;
our ability to scale up our production capabilities for larger quantities of our products; and
our ability to control costs.

We expect to devote substantial capital resources to, among other things, fund operations, continue development programs, and to build out and increase our portfolio of product candidates. If we are unable to secure such additional financing, it will have a material adverse effect on our business and we may have to limit operations in a manner inconsistent with our development and commercialization plans. If additional funds are raised through the issuance of equity securities or convertible debt securities, it will be dilutive to our stockholders and could result in a decrease in our stock price.

We have funded our operations primarily with proceeds from public and private offerings of our common stock. Our history of operating losses and cash uses, our projections of the level of cash that will be required for our operations to reach profitability, and the restricted availability of credit for emerging industries, may impair our ability to raise capital on terms that we consider reasonable and at the levels that we will require over the coming months. We cannot provide any assurances that we will be able to secure additional funding from public or private offerings on terms acceptable to us, if at all. If we are unable to obtain the requisite amount of financing needed to fund our planned operations, it would have a material adverse effect on our business and ability to continue as a going concern.

If adequate funds are not available in the future, we may not be able to develop or enhance our product candidates, take advantage of future opportunities, or respond to competitive pressures or unanticipated requirements and we may be required to delay or terminate research and development programs, curtail capital expenditures, and reduce business development and other operating activities. Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, the consequences could have a material adverse effect on our business, operating results, financial condition and prospects.

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

During the fiscal quarter ended July 31, 2018, we issued to eight employees options to purchase 125,500 shares of common stock at a weighted-average exercise price of $20.60 per share. We also issued to one of those employees a restricted share award for 10,000 shares of common stock with a fair market value on the date of grant equal to $22.53. The options and restricted share award were issued in reliance on the exemption from registration set forth in Section 4(a)(2) of the Securities Act of 1933, as amended.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

Our trading symbol on the Nasdaq Stock Market is scheduled to change from “COOL” to “PTE” on September 17, 2018.

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Item 6. Exhibits

 

Except as otherwise noted, the following exhibits are included in this filing:

 

2.1Asset Purchase Agreement dated March 2, 2018 (1)
2.2Purchase and Sale Agreement dated March 2, 2018 (1)
2.3First Amendment to Asset Purchase Agreement dated April 9, 2018 (1)
2.4First Amendment to Purchase and Sale Agreement dated April 9, 2018 (1)
10.1

Executive Employment Agreement with Paul Mann dated May 12, 2018, with addendum dated June 3, 2018, and confirmation dated June 20, 2018

10.2Stock Option Agreement with Paul Mann dated June 20, 2018
10.3Restricted Stock Unit Agreement with Paul Mann dated June 20, 2018
10.4Restricted Stock Unit Agreement with Peter A. Cohen dated June 29, 2018
10.5Restricted Stock Unit Agreement with Willie C. Bogan dated July 3, 2018Richard Hague effective April 8, 2019
31.1Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INSXBRL Instance Document.
101.SCHXBRL Schema Document.
101.CALXBRL Calculation Linkbase Document.
101.DEFXBRL Definition Linkbase Document.
101.LABXBRL Label Linkbase Document.
101.PREXBRL Presentation Linkbase Document.

 

(1) These documents were filed as exhibits to the current report on Form 8-K filed by the Company with the SEC on May 8, 2018, and are incorporated herein by this reference.

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SIGNATURES

 

Pursuant to the requirements 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.

 

POLARITYTE, INC.

 

 /s/ Denver Lough 
 Denver Lough 
 Chief Executive Officer 
 (Principal Executive Officer) 
   
Date:September 14, 2018March 10, 2019 
   
 /s/ Paul Mann 
 Paul Mann 
 Chief Financial Officer 
 (Principal Financial and Accounting Officer) 
   
Date:September 14, 2018May 10, 2019 

 

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