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 June 30, 2019March 31, 2020

 

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.)

 

123 Wright Brothers Drive

Salt Lake City, UT 84116

(Address of principal executive offices)

 

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

 

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

 

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

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

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(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes [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 August 2, 2019,May 7, 2020, there were 25,824,86238,463,599 shares of the Registrant’s common stock outstanding.

 

 

 

 

 

 

INDEX

 

 Page
PART I - FINANCIAL INFORMATION 
  
Item 1. Financial Statements:3
Condensed Consolidated Balance Sheets as of June 30, 2019 (unaudited)March 31, 2020 and December 31, 20182019 (unaudited)43
Condensed Consolidated Statements of Operations for the three and six months ended June 30,March 31, 2020 and 2019 and 2018 (unaudited)54
Condensed Consolidated Statements of Comprehensive Loss for the three and six months ended June 30,March 31, 2020 and 2019 and 2018 (unaudited)65
Condensed Consolidated Statements of Stockholders’ Equity for the three and six months ended June 30,March 31, 2020 and 2019 and 2018 (unaudited)76
Condensed Consolidated Statements of Cash Flows for the sixthree months ended June 30,March 31, 2020 and 2019 and 2018 (unaudited)87
Notes to Condensed Consolidated Financial Statements (unaudited)98
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations2522
Item 3. Quantitative and Qualitative Disclosures about Market Risk3130
Item 4. Controls and Procedures3130
  
PART II - OTHER INFORMATION31
  
Item 1. Legal Proceedings1A. Risk Factors32
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds3331
Item 6. Exhibits3337
SIGNATURES3438

 

2

 

 

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.

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements:

 

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

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

 

 June 30, 2019  December 31, 2018  March 31, 2020  December 31, 2019 
 (Unaudited)         
ASSETS                
        
Current assets:        
Current assets        
Cash and cash equivalents $45,887  $55,673  $38,517  $10,218 
Short-term investments  12,342   6,162   997   19,022 
Accounts receivable  1,336   712 
Accounts receivable, net  1,186   1,731 
Inventory  362   336   233   252 
Prepaid expenses and other current assets  1,918   1,432   2,807   1,264 
Total current assets  61,845   64,315   43,740   32,487 
Non-current assets:        
Property and equipment, net  16,200   13,736   15,022   14,911 
Operating lease right-of-use assets  5,454      4,142   4,590 
Intangible assets, net  825   924   683   731 
Goodwill  278   278   278   278 
Other assets  353   913   598   602 
Total non-current assets  23,110   15,851 
TOTAL ASSETS $84,955  $80,166  $64,463  $53,599 
                
LIABILITIES AND STOCKHOLDERS’ EQUITY                
        
Current liabilities:        
Current liabilities        
Accounts payable and accrued expenses $5,977  $6,508  $8,026  $7,095 
Other current liabilities  2,646   316   3,223   2,338 
Current portion of long-term note payable  538   529   536   528 
Deferred revenue  44   170   23   98 
Total current liabilities  9,205   7,523   11,808   10,059 
Long-term note payable, net  236   479 
Common stock warrant liability  7,145    
Operating lease liabilities  3,833      2,614   2,994 
Other long-term liabilities  1,315   131   1,243   1,630 
Total liabilities  14,589   8,133   22,810   14,683 
                
Commitments and Contingencies        
Commitments and Contingencies (Note 12)        
                
STOCKHOLDERS’ EQUITY:        
Preferred stock - 25,000,000 shares authorized, 0 shares issued and outstanding at June 30, 2019 and December 31, 2018      
Common stock - $.001 par value; 250,000,000 shares authorized; 25,218,606 and 21,447,088 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively  25   21 
STOCKHOLDERS’ EQUITY        
Preferred stock - 25,000,000 shares authorized, 0 shares issued and outstanding at March 31, 2020 and December 31, 2019      
Common stock – $.001 par value; 250,000,000 shares authorized; 38,393,289 and 27,374,653 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively  38   27 
Additional paid-in capital  461,491   414,840   490,009   474,174 
Accumulated other comprehensive income  79   36   3   72 
Accumulated deficit  (391,229)  (342,864)  (448,397)  (435,357)
Total stockholders’ equity  70,366   72,033   41,653   38,916 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $84,955  $80,166  $64,463  $53,599 

 

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

 

3

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 six months ended 
  June 30,  June 30, 
  2019  2018  2019  2018 
Net revenues                
Products $504  $189  $801  $192 
Services  822   131   1,990   131 
Total net revenues  1,326   320   2,791   323 
Cost of sales                
Products  342   125   615   126 
Services  254   41   757   41 
Total cost of sales  596   166   1,372   167 
Gross profit  730   154   1,419   156 
Operating costs and expenses                
Research and development  4,764   2,915   10,116   8,488 
General and administrative  15,060   11,290   32,255   18,863 
Sales and marketing  3,981      7,934    
Total operating costs and expenses  23,805   14,205   50,305   27,351 
Operating loss  (23,075)  (14,051)  (48,886)  (27,195)
Other income (expenses)                
Interest income, net  29   51   99   88 
Other income, net  254      422    
Change in fair value of derivatives           1,850 
Loss on extinguishment of warrant liability           (520)
Net loss  (22,792)  (14,000)  (48,365)  (25,777)
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 $(22,792) $(14,000) $(48,365) $(33,723)
                 
Net loss per share, basic and diluted:                
Net loss $(0.92) $(0.74) $(2.09) $(1.82)
Deemed dividend – accretion of discount on Series F preferred stock           (0.05)
Deemed dividend – exchange of Series F preferred stock           (0.50)
Cumulative dividends on Series F preferred stock           (0.01)
Net loss attributable to common stockholders $(0.92) $(0.74) $(2.09) $(2.38)
Weighted average shares outstanding, basic and diluted:  24,768,453   18,944,964   23,190,343   14,187,518 

  For the Three Months Ended March 31, 
  2020  2019 
Net revenues        
Products $428  $297 
Services  505   1,168 
Total net revenues  933   1,465 
Cost of sales        
Products  340   273 
Services  176   503 
Total costs of sales  516   776 
Gross profit  417   689 
Operating costs and expenses        
Research and development  3,373   5,352 
General and administrative  11,057   17,195 
Sales and marketing  3,694   3,953 
Total operating costs and expenses  18,124   26,500 
Operating loss  (17,707)  (25,811)
Other income (expense)        
Change in fair value of common stock warrant liability  4,532    
Interest (expense) income, net  (12)  70 
Other income, net  147   168 
Net loss $(13,040) $(25,573)
Net loss per share, basic and diluted $(0.39) $(1.18)
Weighted average shares outstanding, basic and diluted  33,019,994   21,594,699 

 

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

 

4

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(Unaudited, in thousands)

 

 For the three months ended For the six months ended 
 June 30,  June 30,  For the Three Months Ended March 31, 
 2019  2018  2019  2018  2020  2019 
Net loss $(22,792) $(14,000) $(48,365) $(25,777) $(13,040) $(25,573)
Other comprehensive income:                        
Unrealized gain on available-for-sale securities  26      43      4   152 
Reclassification of realized gains included in net loss  (73)  (135)
Comprehensive loss $(22,766) $(14,000) $(48,322) $(25,777) $(13,109) $(25,556)

 

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

5

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

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

 

 For the three and six months ended June 30, 2019  For the Three Months Ended March 31, 2020 
 Common Stock Additional Paid-in Accumulated Other Comprehensive Accumulated Total Stockholders’  Common Stock  Additional Paid-in  Accumulated Other Comprehensive  Accumulated  Total Stockholders’ 
 Number Amount Capital Income Deficit Equity  Number  Amount  Capital  Income  Deficit  Equity 
December 31, 2018  21,447,088 $21 $414,840 $36 $(342,864) $72,033 
Balance - December 31, 2019  27,374,653  $27  $474,174  $72  $(435,357) $38,916 
Issuance of common stock, net of issuance costs of $1.3 million  10,854,710   11   12,588         12,599 
Stock-based compensation expense   10,327   10,327         3,221         3,221 
Stock option exercises 283,250 1 528   529   10,000      31         31 
Vesting of restricted stock units 100,912        158,513                
Shares withheld for tax withholding (82,011)  (740)   (740)  (4,587)     (5)        (5)
Other comprehensive income    17  17 
Other comprehensive loss           (69)     (69)
Net loss          (25,573)  (25,573)              (13,040)  (13,040)
March 31, 2019 21,749,239 $22 $424,955 $53 $(368,437) $56,593 
Proceeds received from issuance of common stock, net of issuance costs of $1,146 3,418,918 3 27,945   27,948 
Stock-based compensation expense   8,618   8,618 
Stock option exercises 9,167      
Shares issued under the ESPP 7,260  35   35 
Vesting of restricted stock units 51,440      
Shares withheld for tax withholding (17,418  (62)   (62)
Other comprehensive income    26  26 
Net loss          (22,792)  (22,792)
June 30, 2019  25,218,606 $25 $461,491 $79 $(391,229) $70,366 
Balance - March 31, 2020  38,393,289  $38  $490,009  $3  $(448,397) $41,653 

 

  For the three and six months ended June 30, 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 
Proceeds received from issuance of common stock, net of issuance costs of $2,782        4,791,819   4   92,672      92,676 
Stock-based compensation expense        175,887      8,344      8,344 
Stock option exercises        20,000      64      64 
Net loss                 (14,000)  (14,000)
June 30, 2018    $   21,445,370  $20  $390,538  $(295,697) $94,861 
  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 
Balance - 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  283,250   1   528         529 
Vesting of restricted stock units  100,912                
Shares withheld for tax withholding  (82,011)     (740)        (740)
Other comprehensive income           17      17 
Net loss              (25,573)  (25,573)
Balance - March 31, 2019  21,749,239  $22  $424,955  $53  $(368,437) $56,593 

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

6

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited, in thousands)

  For the Three Months ended
March 31,
 
  2020  2019 
CASH FLOWS FROM OPERATING ACTIVITIES        
Net loss $(13,040) $(25,573)
Adjustments to reconcile net loss to net cash used in operating activities:        
Stock based compensation expense  3,221   10,289 
Depreciation and amortization  752   676 
Amortization of intangible assets  48   51 
Amortization of debt discount  8   15 
Change in fair value of common stock warrant liability  (4,532)   
Change in fair value of contingent consideration     20 
Other non-cash adjustments  (16)  (7)
Changes in operating assets and liabilities:        
Accounts receivable  545   (76)
Inventory  19   27 
Prepaid expenses and other current assets  (1,543)  (412)
Operating lease right-of-use assets  448   355 
Other assets  4    
Accounts payable and accrued expenses  818   (1,331)
Other current liabilities  (61)  425 
Deferred revenue  (75)  (80)
Operating lease liabilities  (450)  (343)
Other long-term liabilities     (4)
Net cash used in operating activities  (13,854)  (15,968)
CASH FLOWS FROM INVESTING ACTIVITIES        
Purchase of property and equipment  (999)  (1,539)
Purchase of available-for-sale securities  (14,144)  (5,220)
Proceeds from maturities of available-for-sale securities  15,945   1,700 
Proceeds from sale of available-for-sale securities  16,171    
Net cash provided by (used in) investing activities  16,973   (5,059)
CASH FLOWS FROM FINANCING ACTIVITIES        
Net proceeds from the sale of common stock and warrants  24,276    
Proceeds from stock options exercised  31   529 
Cash paid for tax withholdings related to net share settlement  (2)   
Payment of contingent consideration liability     (109)
Principal payments on financing leases  (123)  (118)
Proceeds from financing arrangements  1,053    
Principal payments on financing arrangements  (55)   
Net cash provided by financing activities  25,180   302 
Net increase (decrease) in cash and cash equivalents  28,299   (20,725)
Cash and cash equivalents - beginning of period  10,218   55,673 
Cash and cash equivalents - end of period $38,517  $34,948 
Non-cash investing and financing activities:        
Unpaid liability for acquisition of property and equipment $137  $170 
Reclassification of stock-based compensation expense that was previously classified as a liability to paid-in capital $  $38 
Unpaid tax liability related to net share settlement $3  $617 
Allocation of proceeds from sale of common stock and warrants to warrant liability $11,677  $ 


 

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

 

7

 

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited, in thousands)

  For the six months ended June 30, 
  2019  2018 
CASH FLOWS FROM OPERATING ACTIVITIES        
Net loss $(48,365) $(25,777)
Adjustments to reconcile net loss to net cash used in operating activities:        
Stock based compensation expense  18,907   15,789 
Change in fair value of derivatives     (1,850)
Depreciation and amortization  1,446   672 
Loss on extinguishment of warrant liability     520 
Amortization of intangible assets  99   33 
Amortization of debt discount  28   11 
Change in fair value of contingent consideration  (48)  20 
Other non-cash adjustments  30    
Changes in operating assets and liabilities:        
Accounts receivable  (624)  (332)
Inventory  (26)  (249)
Prepaid expenses and other current assets  (486)  2 
Operating lease right-of-use assets  791    
Other assets  25   (137)
Accounts payable and accrued expenses  (17)  448 
Other current liabilities  367    
Deferred revenue  (126)   
Operating lease liabilities  (670)   
Other long-term liabilities  (120)  89 
Net cash used in operating activities  (28,789)  (10,761)
CASH FLOWS FROM INVESTING ACTIVITIES        
Purchase of property and equipment  (2,110)  (4,163)
Purchase of available-for-sale securities  (15,445)   
Proceeds from maturities of available-for-sale securities  9,278    
Acquisition of IBEX     (2,258)
Net cash used in investing activities  (8,277)  (6,421)
CASH FLOWS FROM FINANCING ACTIVITIES        
Net proceeds from the sale of common stock  27,948   92,676 
Proceeds from stock options exercised  529   64 
Proceeds from ESPP purchase  35    
Cash paid for tax withholdings related to net share settlement  (636)   
Payment of contingent consideration liability  (109)   
Principal payments on financing leases  (225)   
Principal payments on term note payable  (262)   
Net cash provided by financing activities  27,280   92,740 
         
Net (decrease) increase in cash and cash equivalents  (9,786)  75,558 
Cash and cash equivalents - beginning of period  55,673   12,517 
Cash and cash equivalents - end of period $45,887  $88,075 
         
Supplemental schedule of non-cash investing and financing activities:        
Conversion of Series A, B, E preferred stock to common stock $  $109,104 
Exchange of Series F preferred stock for common stock     13,061 
Extinguishment of warrant liability     2,525 
Unpaid liability for acquisition of property and equipment  63   441 
Deemed dividend – accretion of discount on Series F preferred stock     698 
Cumulative dividends on Series F preferred stock     191 
Series F preferred stock dividends paid in common stock     306 
Unpaid tax liability related to net share settlement  43    
Unrealized gain on short-term investments and cash equivalents  43    
Reclassification of stock-based compensation expense that was previously classified as a liability to paid-in capital  38    
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 

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

8

 

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 company developing and regenerative biomaterials company focused on transforming the lives of patients by discovering, designing and developing a range ofcommercializing regenerative tissue products and biomaterials for the fields of medicine, biomedical engineering and material sciences.

Change in Fiscal Year end.On January 11, 2019, the Board approved an amendment to the Restated Bylaws of the Company changing the Company’s fiscal year end from October 31 to December 31. As such, the end of the quarters in the new fiscal year do not coincide with the end of the quarters in the Company’s previous fiscal years. The Company made this change to align its fiscal year end with other companies within its industry.biomaterials.

 

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 December 31, 20182019 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 (U.S. GAAP) for complete financial statements. These interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the two-month periodyear ended December 31, 2018 included in the Company’s Transition Report on Form 10-KT2019 filed with the Securities and Exchange Commission on Form 10-K on March 18, 2019.12, 2020.

 

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Principles of Consolidation.The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. Significant intercompany accounts and transactions have been eliminated in consolidation.

 

Use of estimates.The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”)GAAP requires management to make estimates and assumptions 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, valuation of common stock warrant liability, and the valuation allowances for deferred tax benefits, and the valuation of tangible and intangible assets included in acquisitions.benefits. Actual results could differ from those estimates.

 

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. TheIn April 2020, the Company designated its Chief Executive Officer (CEO) to be its Chief Operating Decision Maker (CODM) is ourand dissolved the function of the Office of the Chief Executive consisting of the President, Chief Operating Officer, theand Chief Financial Officer and the President of Corporate Development.which previously acted as its CODM. 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 of IBEX, the Company operated in one segment.

 

Cash and cash equivalents. Cash equivalents consist of highly liquid investments with original maturities of three months or less from the date of purchase.

Investments. Investments in debt securities have been classified as available-for-sale and are carried 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 specific-identification method. Interest on marketable securities is included in interest income, net. Investments with original maturities of greater than three months but less than one year from the date of purchase are classified as current. Investments with original maturities of greater than one year from the date of purchase are classified as non-current.

Loss Per Share.Basic loss per share of common stock is computed by dividing net loss attributable to common stockholders by the weighted 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. Finance leases are reported in the condensed consolidated balance sheet in property and equipment and other current and long-term liabilities. The short-term portion of operating lease obligations are included in other current liabilities. 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 lease 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 lease liability and also includes any lease payments made prior to or 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 reasonably 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 lease 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 and interest expense associated with its finance leases is recognized on the balance of the lease liability using the effective interest method based on the estimated incremental borrowing rate.

 

8

The Company has lease agreements with lease and non-lease components. As allowed under TopicASC 842, the Company has 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 lease and non-lease components as a single lease component. The Company has also elected not to apply the recognition requirement of TopicASC 842 to leases with a term of 12 months or less for all classes of assets.

 

Stock- Based Compensation.Revenue Recognition. Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company 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 product revenues primarily from the sale of its regenerative tissue products. The Company measures all stock-based compensationsells its products to employees usinghealthcare providers (customers), primarily through direct sales representatives. Product revenues consist of a fair value method and records such expensesingle performance obligation that the Company satisfies at a point in time. In general, and administrative and research and development expenses. For stock options with graded vesting, the Company recognizes compensation expenseproduct revenue upon delivery to the customer.

In the contract services segment, the Company records service revenues from the sale of its 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 an appropriate measure of the transfer of services over the service period for each separately vesting trancheterm of the award as though the award were in substance, multiple awardsperformance obligation based on the fair valueremaining 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 datepayment is due upfront and the remainder upon completion of grant.the contract, with most contracts completing in less than a year. As of March 31, 2020 and December 31, 2019, the Company had unbilled receivables of $0.1 million and $0.1 million, and deferred revenue of $23,000 and $98,000, respectively. The unbilled receivables balance is included in accounts receivable. Revenue of $0.1 million was recognized during the three months ended March 31, 2020 that was included in the deferred revenue balance as of December 31, 2019.

 

The fair valueCosts to obtain the contract are incurred 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 recognizedproducts revenues as they occur.are shipped and are expensed as incurred.

 

The value of restricted stock 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.

The accounting for non-employee options and restricted stock is similar to that of employees. Stock-based compensation expense for nonemployee services has historically been subject to remeasurement at each reporting date as the underlying equity instruments vest and was recognized as an expense over the period during which services are received. Upon the adoption of ASU 2018-07, Compensation – Stock Compensation on January 1, 2019, the valuation was fixed at the implementation date and will be recognized as an expense on a straight-line basis over the remaining service period.

Research and Development Expenses. Costs incurred for research and development are expensed as incurred.

Nonrefundable advance payments for goods or services that have the characteristics that will be used or rendered for future research and development activities pursuant to executory contractual arrangements with third party research organizations are deferred and recognized as an expense as the related goods are delivered or the related services are performed.

Accruals for Research and Development Expenses and Clinical Trials. As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment terms that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the timing of various aspects of the expenses. The Company determines accrual estimates by taking into account discussion with applicable personnel and outside service providers as to the progress of clinical trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period.

 

9

Prior Quarter Adjustment.

Common Stock Warrant Liability. Previously reported amountsThe Company accounts for the three months ended March 31, 2019 have been correctedcommon stock warrants issued as freestanding instruments in the Company’s Condensed Consolidated Statement of Stockholders’ Equity related to the overstatement of “Stock option exercises, net” offset by the overstatement of “Shares withheld for tax withholding” in the amount of $598,000. The change is due to the Company correcting itsaccordance with applicable accounting for cashless exercises of stock options. Such correction does not impact the ending balance of “Additional paid-in capital”guidance as either liabilities or as equity instruments depending on the Condensed Consolidated Balance Sheets,specific terms of the warrant agreement. The Company’s warrants under certain change of control situations, could require settlement in cash, which require the warrants to be recorded as liabilities. Warrants classified as liabilities are remeasured each period until settled or “Net loss” on the Condensed Consolidated Statement of Operationsuntil classified as of and for the three months ended March 31, 2019. This correction is also reflected in the “Proceeds from stock options exercised” presented in the Cash Flows from Financing Activities and “Changes in operating assets and liabilities: Accounts payable and accrued expenses” presented in the Cash Flows from Operating Activities in the Condensed Consolidated Statement of Cash Flows for the six months ended June 30, 2019. The Company evaluated this correction considering both quantitative and qualitative factors and concluded it was immaterial to previously issued condensed consolidated financial statements.equity.

 

Revenue Recognition.Stock-Based Compensation. Revenue is recognized whenThe Company measures all stock-based compensation to employees and non-employees using a customer obtains control of promised goods or services,fair value method and records such expense 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,general and administrative, research and development, and sales and marketing expenses. For stock options with graded vesting, the Company performsrecognizes compensation expense over the following five steps: (i) identifyservice period for each separately vesting tranche of the contract(s) with a customer; (ii) identifyaward as though the performance obligationsaward were in substance, multiple awards based on the contract; (iii) determinefair value on 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.date of grant.

 

InThe fair value for options issued is estimated at the regenerative medicine products segment,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 fair value of restricted stock 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 common stock is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period.Since the Company records products revenues primarily fromwas in a loss position for all periods presented, basic net loss per share is the salesame as diluted net loss per share since the effects of its regenerative tissue products.potentially dilutive securities are antidilutive.

Impairment of Long-Lived Assets. The Company sells its products to healthcare providers, primarily through direct sales representatives. Products revenues consistsreviews long-lived assets, including property and equipment, intangible assets and goodwill for impairment whenever events or changes in business circumstances indicate that the carrying amount of a single performance obligationthe assets may not be fully recoverable. Factors that the Company satisfies atconsiders 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 point in time. In general,long-lived asset for recoverability, the Company recognizes products revenues upon deliverycompares forecasts of undiscounted cash flows expected to the customer.

In the contract services segment, the Company records services revenuesresult from the saleuse and eventual disposition of the long-lived asset to its contract research services, which includes delivery of preclinical studies and other research services to unrelated third parties. Services 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 costscarrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to be required to satisfyresult from the performance obligation.use of an asset are less than its carrying amount. The Company believes that this method provides a faithful depiction of the transfer of services over the term of the performance obligationimpairment loss would be based on the remaining services needed to satisfy the obligation. This requires the Company to make reasonable estimatesexcess of the extent of progress toward completioncarrying value of the contract. As a result, unbilled receivables and deferred revenue are recognizedimpaired asset over its fair value, determined based on payment timing and work completed. Generally, a portiondiscounted cash flows. There were no impairments of long-lived assets for any of the payment is due upfront and the remainder upon completion of the study, with most studies completing in less than a year. As of June 30, 2019 and December 31, 2018, the Company had unbilled receivables of $220,000 and $157,000 and deferred revenue of $44,000 and $170,000, respectively. The unbilled receivables balance is included in consolidated accounts receivable. Revenues of $164,000 were recognized during the six months ended June 30, 2019 that were included in the deferred revenue balance at the beginning of the period.

Costs to obtain the contract are incurred for products revenues as they are shipped and are expensed as incurred.periods presented

 

Recent Accounting Pronouncements

In August 2018, the FASB issued ASU 2018-13,Fair Value Measurement (Topic 820), Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement. The ASU modifies the disclosure requirements for fair value measurements by removing, modifying or adding 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 impact that the standard will have on its consolidated financial statements and related disclosures.

In June 2016, the FASB 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 date based on historical experience, current conditions, and reasonable and supportable forecasts. This replaces the existing 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. In November 2019, the FASB issued ASU No. 2019-10,Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and Leases (Topic 842): Effective Dates, which defers the effective date of Topic 326. As a smaller reporting company, Topic 326 will now be effective for the Company beginning January 1, 2023. As such, the Company plans to adopt this ASU beginning January 1, 2023. The Company is currently evaluating the impact that the standard will have on its consolidated financial statements and related disclosures.

 

10

Recently Adopted Accounting Pronouncements

 

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 leases 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 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. 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.

We elected the package of practical 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 the 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:            
Accounts payable and accrued expenses $6,508  

$

(75) 

$

6,433 
Other current liabilities  316   1,432   1,748 
Operating lease liabilities   3,948  3,948 

The adjustments due to the adoption of ASC 842 related to the recognition of operating lease right-of-use assets and operating lease liabilities for the existing operating leases. A cumulative-effect adjustment to beginning accumulated deficit was not required.

In JuneAugust 2018, the FASB issued ASU 2018-07,2018-13,Compensation – Stock CompensationFair Value Measurement (Topic 718): Improvements820), Disclosure Framework-Changes to Nonemployee Share-based Payment Accountingthe Disclosure Requirements for Fair Value Measurement. The standard expandsASU modifies the scope of Topic 718 to include share-based payments issued to nonemployeesdisclosure requirements for goodsfair value measurements by removing, modifying or services, simplifying the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, withadding certain exceptions.disclosures. The standard is effective for fiscal years beginning after December 15, 2018,2019, including interim periods within those fiscal years with early adoption permitted, including adoption in an interim period.permitted. The Company adopted this ASUstandard on January 1, 2019.2020. The adoption of this ASU did not have a material impact on the Company’s condensed consolidated financial statements and related disclosures.

 

3. LIQUIDITY AND NEED FOR ADDITIONAL CAPITAL

 

The Company has experienced recurring losses and cash outflows from operating activities. Since inception through June 30, 2019,As of March 31, 2020, the Company hashad an accumulated deficit of $391.2$448.4 million. As of June 30, 2019,March 31, 2020, the Company had cash and cash equivalents and short-term investments of $58.2$39.5 million.

 

On April 10, 2019, the Company completed an underwritten offering 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 $27.9 million, after deducting offering expenses payable by the Company.

 

On December 5, 2019, the Company entered into an Equity Purchase Agreement (the “Purchase Agreement”), with Keystone Capital Partners, LLC (“Keystone”), pursuant to which Keystone has agreed to purchase from the Company up to $25.0 million of shares of its common stock, subject to certain limitations including a minimum stock price of $2.00, at the direction of the Company from time to time during the 36-month term of the Purchase Agreement. Concurrently, the Company entered into a Registration Rights Agreement with Keystone, pursuant to which it agreed to register the sales of its common stock pursuant to the Purchase Agreement under the Company’s existing shelf registration statement on Form S-3 or a new registration statement. On December 19, 2019, the Company sold 54,090 shares under the Purchase Agreement at a purchase price of $2.31 per share, for total proceeds of $0.1 million. During the three months ended March 31, 2020, the Company completed four additional sales of common stock to Keystone under the Purchase Agreement for a total of 216,412 shares generating total gross proceeds of $0.6 million.

On February 14, 2020, the Company completed an underwritten offering of 10,638,298 shares of its common stock and warrants to purchase 10,638,298 shares of common stock. Each common share and warrant were sold together for a combined public purchase price of $2.35 before underwriting discount and commission. The exercise price of each warrant is $2.80 per share, the warrants were exercisable immediately, and they will expire February 12, 2027. The net proceeds to the Company from the offering were $22.5 million, after offering expenses payable by the Company. In connection with this agreement, the Company agreed not to sell any additional shares under the Keystone Purchase Agreement for a period of 90 days after the closing date of the offering.

Based upon the current status of the Company’sour product development and commercialization plans, the Company believes that its existing cash and cash equivalents, with planned operating cost reductions, and short-term investmentsproceeds from the Loan, will be adequate to satisfy its capital and operating needs for at least the next 12 months from the date of filing. However,As noted in our April 21, 2020 press release, we have already taken action to reduce future cash burn by reducing payroll expense, adopting a salary and wage reduction, and reducing discretionary spending across the organization to minimal levels. As discussed in our April 30, 2020 press release updating corporate strategy and regulatory pathway for SkinTE, we are substantially reducing commercial operations and other functions to further significantly decrease cash burn. The Company anticipates needing substantialbelieves it may need additional financing to continue clinical deployment and commercialization of its lead product SkinTE and development of its other product candidates, and scaling the manufacturing capacity for its products and product candidates and prepare for commercial readiness. However, thecandidates. The Company will continue to pursue fundraising opportunities when available, but such financing may not be available in the future on terms favorable to the Company,terms, if at all. If adequate financing is not available, the Company may be required to delay, reduce the scope of, or eliminate one or more of its product development programs.programs, or be unable to continue operations over a longer term. The Company plans to meet its capital requirements primarily through issuances of equity securities, debt financing, revenue from product and services sales and future collaborations.or strategic partnership arrangements. Failure to generate revenuecash from revenues, or raise additional capital, would adversely affect the Company’s ability to achieve its intended business objectives.

11

 

4. FAIR VALUE

 

In 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.

 

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 Series F Preferred Shares and warrants to purchase an aggregate of 322,727 shares of common stock. 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. The 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.

As discussed in Note 10, 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 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 – June 30, 2018 $  $  $ 

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 June 30, 2019 and December 31, 2018 (in thousands):

 

 Fair Value Measurement as of June 30, 2019  March 31, 2020 
 Level 1 Level 2 Level 3 Total  Level 1  Level 2  Level 3  Total 
Assets:                  
Money market funds $37 $ $ $37  $19,065  $  $  $19,065 
Commercial paper  19,984  19,984      747      747 
Corporate debt securities  12,342  12,342      997      997 
U.S. government debt securities    8,105    8,105 
Total $37 $40,431 $ $40,468  $19,065  $1,744  $  $20,809 
Liabilities:                         
Contingent consideration $ $ $135 $135 
Common stock warrant liability $  $  $7,145  $7,145 
Total $ $ $135 $135  $  $  $7,145  $7,145 

 

 Fair Value Measurement as of December 31, 2018  December 31, 2019 
 Level 1 Level 2 Level 3 Total  Level 1  Level 2  Level 3  Total 
Assets:                  
Money market funds $7 $ $ $7  $2,019  $  $  $2,019 
Commercial paper  21,392  21,392      11,064      11,064 
Corporate debt securities  5,448  5,448      8,982      8,982 
U.S. government debt securities    3,226    3,226      3,770      3,770 
Total $7 $30,066 $ $30,073  $2,019  $23,816  $  $25,835 
Liabilities:                         
Contingent consideration $ $ $261 $261  $  $  $31  $31 
Total $ $ $261 $261  $  $  $31  $31 

 

In May 2018, the Company purchased the assets of a preclinical 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, “IBEX”). 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 IBEX with an initial fair value of $1.2 millionthe common stock warrant liability is estimated using a Monte Carlo simulation model, which uses certain assumptions related to risk-free interest rates, expected volatility, and contingent consideration with an initialexpected term. The fair value of $0.3the warrant liability was $11.7 million upon the issuance date of February 14, 2020 and $7.1 million as of March 31, 2020.

12

The following assumptions were used in estimating the fair value of the warrant liability as of March 31, 2020 and upon the issuance date of February 14, 2020:

  March 31, 2020  February 14, 2020 
Stock price $1.08  $1.69 
Exercise price $2.80  $2.80 
Risk-free rate  0.54%  1.51%
Volatility  94.21%  93.40%
Term  6.87   6.99 

 

The contingent consideration represents the estimated fair value of future payments duerelated to the SellerIBEX acquisition of IBEX based on IBEX’s revenue generated from studies quoted prior$31,000 outstanding at December 31, 2019, was paid during the three months ended March 31, 2020. As of March 31, 2020, the obligation related to but completed after the transaction. Contingent consideration was 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 payments will not exceed $650,000. Adjustments to the fair value of the contingent consideration liability is included in general and administrative expense in the accompanying consolidated statements of operations.fully satisfied.

The following table sets forth the changes 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  (48)
Earned and paid  (78)
Fair value – June 30, 2019 $135 

15

 

5. CASH EQUIVALENTS AND AVAILABLE FOR SALE MARKETABLE SECURITIESSHORT-TERM INVESTMENTS

 

Cash equivalents and available-for-sale marketable securitiesshort-term investments consisted of the following as of June 30, 2019 and December 31, 2018 (in thousands):

 

 June 30, 2019  March 31, 2020 
 Amortized Cost Unrealized Gains Unrealized Losses Market Value  Amortized Cost  Unrealized Gains  Unrealized Losses  Market Value 
Cash equivalents:                         
Money market funds $37 $ $ $37  $19,065  $    –  $ –  $19,065 
Commercial paper 19,960 24  19,984   747         747 
U.S. government debt securities  8,074  31    8,105 
Total cash equivalents (1)  28,071  55    28,126   19,812         19,812 
Short-term investments:                         
Corporate debt securities  12,318  24    12,342   994   3      997 
Total short-term investments  12,318  24    12,342   994   3      997 
Total $40,389 $79 $ $40,468  $20,806  $3  $  $20,809 

 

 (1)Included in cash and cash equivalents in the Company’s consolidated balance sheet as of June 30, 2019March 31, 2020 in addition to $17.8$18.7 million of cash.

 

 December 31, 2018  December 31, 2019 
 Amortized Cost Unrealized Gains Unrealized Losses Market Value  Amortized Cost  Unrealized Gains  Unrealized Losses  Market Value 
Cash equivalents:                         
Money market funds $7 $ $ $7  $2,019  $  $  $2,019 
Commercial paper 20,648 30  20,678   1,020   4      1,024 
U.S. government debt securities  3,224  2    3,226   3,761   9      3,770 
Total cash equivalents (1)  23,879  32    23,911   6,800   13      6,813 
Short-term investments:                         
Commercial paper 714   714   9,986   54      10,040 
Corporate debt securities  5,444  5  (1)  5,448   8,977   5      8,982 
Total short-term investments  6,158  5  (1)  6,162   18,963   59      19,022 
Total $30,037 $37 $(1) $30,073  $25,763  $72  $  $25,835 

 

 (1)Included in cash and cash equivalents in the Company’s consolidated balance sheet as of December 31, 20182019 in addition to $31.8$3.4 million of cash.

 

All investments in debt securities held as of June 30, 2019March 31, 2020 and December 31, 20182019 had maturities of less than one year. For the three and six months ended June 30,March 31, 2020 and 2019, the Company recognized no materialnet realized gains or losses on available-for-sale marketable securities.securities of $0.1 million.

13

 

6. PROPERTY AND EQUIPMENT, NET

 

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

 

 June 30, 2019 December 31, 2018  March 31, 2020  December 31, 2019 
Machinery and equipment $11,735  $8,276  $12,089  $12,083 
Land and buildings 2,000 2,000   2,000   2,000 
Computers and software 1,759 1,372   1,276   1,189 
Leasehold improvements 2,272 1,230   2,335   2,282 
Construction in progress 1,582 2,402   2,323   1,606 
Furniture and equipment  470  614   470   470 
Total property and equipment, gross 19,818 15,894   20,493   19,630 
Accumulated depreciation  (3,618)  (2,158)
Accumulated depreciation and amortization  (5,471)  (4,719)
Total property and equipment, net $16,200 $13,736  $15,022  $14,911 

Depreciation and amortization expense for property and equipment, including assets acquired under financing leases for the three and six months ended June 30, 2019 and 2018 was as follows (in thousands):

 

 For the three months ended For the six months ended 
 June 30, June 30,  For the Three Months Ended March 31, 
 2019 2018 2019 2018  2020  2019 
General and administrative expense $407 $9 $764 $9  $392  $357 
Research and development expense  363  345  682  663   360   319 
Total depreciation and amortization expense $770 $354 $1,446 $672  $752  $676 

 

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.

 

In April 2019, the Company entered into an operating lease to obtain 6,307 square feet of manufacturing, laboratory, and office space. The lease expires April 2024 and requires monthly lease payments subject to annual increases. During the six months ended June 30, 2019, the Company also increased office space under an existing lease, which requires additional monthly lease payments.

As of June 30, 2019,March 31, 2020, the maturities of our operating and finance lease liabilities were as follows (in thousands):

 

  Operating leases  Finance leases 
2019 (excluding the six months ended June 30, 2019) $1,166  $301 
2020  2,114   596 
2021  1,731   593 
2022  1,345   328 
2023  133   253 
Thereafter  79   42 
Total lease payments  6,568   2,113 
Less:        
Imputed interest  (917)  (351)
Total $5,651  $1,762 
  Operating leases  Finance leases 
2020 (excluding the three months ended March 31, 2020) $1,555  $494 
2021  1,730   656 
2022  1,345   405 
2023  132   336 
2024  87   42 
Total lease payments  4,849   1,933 
 Less imputed interest  (559)  (281)
Total lease liabilities $4,290  $1,652 

14

 

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

 

Finance leases   
  As of June 30, 2019 
Finance lease right-of-use assets included within property and equipment, net $2,280 
     
Current finance lease liabilities included within other current liabilities $447 
Non-current finance lease liabilities included within other long-term liabilities  1,315 
Total $1,762 

Finance leases

 

Operating leases   
  As of June 30, 2019 
Current operating lease liabilities included within other current liabilities $1,818 
Operating lease liabilities – non current  3,833 
Total $5,651 
  March 31, 2020  December 31, 2019 
Finance lease right-of-use assets included within property and equipment, net $2,005  $2,177 
         
Current finance lease liabilities included within other current liabilities $520  $508 
Non-current finance lease liabilities included within other long-term liabilities  1,132   1,267 
Total finance lease liabilities $1,652  $1,775 

Operating leases

  March 31, 2020  December 31, 2019 
Current operating lease liabilities included within other current liabilities $1,676  $1,746 
Operating lease liabilities – non current  2,614   2,994 
Total operating lease liabilities $4,290  $4,740 

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

 

 For the Three Months Ended March 31, 
 Three months ended June 30, 2019 Six months ended June 30, 2019  2020  2019 
Operating lease costs included within operating costs and expenses $546  $1,061  $556  $482 
Finance lease costs:             
Amortization of right of use assets  $170  $309 
Amortization of right-of-use assets $175  $138 
Interest on lease liabilities  44  67   43   23 
Total  $214 $376  $218  $161 

15

 

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

 

 For the Three Months Ended March 31, 
 

Six months ended

June 30, 2019

  2020  2019 
Cash paid for amounts included in the measurement of lease liabilities:        
Operating cash flows from operating leases $941 
Operating cash flows from finance leases 67 
Financing cash flows from finance leases 225 
Operating cash out flows from operating leases $558  $470 
Operating cash out flows from finance leases  43   23 
Financing cash out flows from finance leases  123   118 
Lease liabilities arising from obtaining right-of-use assets:           
Finance leases $1,824  $  $1,824 
Lease payments made in prior period reclassified to property and equipment 535      535 

Remeasurement of finance lease liability due to lease modification

 (22)
Operating leases 939      9 

 

As of June 30,March 31, 2020 and December 31, 2019, the weighted average remaining operating lease term is 3.2for operating leases was 2.6 and 2.8 years, respectively, and the weighted average discount rate used to determinefor operating leases was 9.84% and 9.83%, respectively. As of March 31, 2020 and December 31, 2019, the operating lease liability was 9.81%. The weighted average remaining finance lease term is 3.8for finance leases was 3.3 and 3.5 years, respectively, and the weighted average discount rate used to determine thefor finance lease liabilityleases was 9.69%9.77%.

 

8. ACCOUNTS PAYABLE AND ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

 

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

 

 June 30, 2019 December 31, 2018  March 31, 2020  December 31, 2019 
Accounts payable $2,122  $2,918  $2,059  $1,689 
Salaries and other compensation 1,655 1,280   1,437   1,462 
Legal and accounting 1,382 640   1,365   1,404 
Other accruals  818  1,670 
Accrued severance  1,843   1,053 
Benefit plan accrual  448   557 
Other  874   930 
Total accounts payable and accrued expenses $5,977 $6,508  $8,026  $7,095 

 

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

 

Other current liabilities are 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 $0.2$1.0 million as of June 30, 2019,March 31, 2020, while the other components are disclosed in the footnotes above. The short-term debt balance is related to two financing arrangements entered into during the three months ended March 31, 2020 to fund an insurance contract. Under the financing arrangements, the Company borrowed $0.8 million and $0.2 million. The amounts will be repaid in nine equal installments, with an interest rate of 4.25% and 6.35%, respectively.

18

 

9. LONG TERM NOTE PAYABLE

In connection with the IBEX Acquisition in May 2018, the Company issued a promissory note payable to the Seller with an initial fair value of $1.2 million. The promissory note has a principal balance of $1.3 million and bears interest at a rate of 3.5% interest per annum. Principal and interest are payable in five equal installments that 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 any 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 $41,000 and $68,000 at June 30, 2019 and December 31, 2018, respectively. Amortization of debt discount of $13,000 and $28,000 was included in interest income, net for the three and six months ended June 30, 2019.

10. PREFERRED SHARES AND COMMON SHARESSTOCK-BASED COMPENSATION

 

Exchange of 100% of Outstanding Series F Preferred Stock Shares2020, 2019 and Warrants2017 Equity Incentive Plans

2020 Plan

 

On September 20, 2017,October 25, 2019, the Company sold an aggregateCompany’s Board of $17,750,000 worthDirectors (the “Board”) approved the Company’s 2020 Stock Option and Incentive Plan (the “2020 Plan”). The 2020 Plan became effective on December 19, 2019, the date approved by the stockholders. The 2020 Plan provides for the grant of incentive stock options, nonqualified stock options, restricted stock, restricted stock units, stock appreciation rights, unrestricted stock awards, dividend equivalent rights, and cash-based awards to the Company’s employees, officers, directors and consultants. The Compensation Committee of the Company’s securities (the “Units”) to accredited investors at a purchase price of $2,750 per Unit. Each Unit consisted of (i) one share ofBoard will administer the Company’s newly authorized 6% Series F Convertible Preferred Stock, par value $0.001 per share (the “Series F Preferred Shares”), 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.

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, would, at the option of the holder, 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 to2020 Plan, including determining which eligible participants will receive awards, the number of common shares issuable under the warrant 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) the Company issues new securities for consideration less than the exercise price. Priorsubject to the adoption of ASU 2017-11, warrants that provide for down-round exercise price protection were recognized as derivative liabilities.

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,awards and the Company’s warrantsterms and conditions of such awards. Up 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 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 1,003,393 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)
Carrying value of bifurcated conversion option at March 5, 2018  (7,162,587)
Deemed dividend on Series F Preferred Shares exchange $7,057,129 

As the Warrants were classified as a liability, the exchange of the Warrants for common shares was 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 six months ended June 30, 2018.

The Company recognized accretion of the discount to the stated value of the Series F Preferred Shares of approximately $698,000 during the six months ended June 30, 2018, 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 7,945,2503,000,000 shares of common stock are issuable pursuant to such holders.

The sharesawards under the 2020 Plan. No grants of Series E Preferred Stock were held by Dr. Denver Lough,awards may be made under the Company’s Chief Executive Officer. On2020 Plan after the later of December 19, 2029, or the tenth anniversary of the latest material amendment of the 2020 Plan and no grants of incentive stock options may be made after October 25, 2029. As of March 6, 2018,31, 2020, 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 7,050,000had 3,000,000 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 144available for future issuances under the Securities Act without restriction. On March 14, 2019, the Company’s registration obligation was waived, and the Lough Registration Rights Agreement amended to provide that Dr. Lough may demand registration by written request to the Company. Dr. Lough has not made a demand for 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 25,000,000 shares of authorized and unissued preferred stock as of June 30, 2019 with no designation as to series.

There was no convertible preferred stock outstanding as of June 30, 2019 and December 31, 2018.

11. STOCK-BASED COMPENSATION

For the three and six months ended June 30, 2019 and 2018, the Company recorded stock-based compensation expense related to stock options and restricted stock awards as follows (in thousands):

  For the three months ended  For the six months ended 
  June 30,  June 30, 
  2019  2018  2019  2018 
General and administrative expense $6,892  $7,035  $15,929  $12,807 
Research and development expense  1,481   1,309   2,565   

2,982

 
Sales and marketing expense  245      413   - 
Total stock-based compensation expense $8,618  $8,344  $18,907  $15,789 

2020 Plan.

Incentive Compensation Plans

16

 

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 June 30, 2019,March 31, 2020, the Company had approximately 1,857,972115,284 shares available for future issuances under the 2019 Plan.

21

 

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 June 30, 2019,March 31, 2020, the Company had approximately 374,0382,230,045 shares available for future issuances under the 2017 Plan.

Stock Options

 

A summary of the Company’s employee and non-employee stock option activity for the sixthree months ended June 30, 2019March 31, 2020 is presented below:

 

  

Number of

shares

  

Weighted-Average

Exercise Price

 
Outstanding – December 31, 2018  6,499,885  $14.02 
Granted  767,201  $        14.36 
Exercised (1)  (292,417) $3.99 
Forfeited  (370,208) $7.81 
Outstanding – June 30, 2019  6,604,461  $14.30 
Options exercisable – June 30, 2019  4,567,527  $12.11 
Weighted-average grant date fair value of options granted during the six months ended June 30, 2019     $10.28 

(1)The number of exercised options includes shares withheld on behalf of employees to satisfy minimum statutory tax withholding requirements.

Restricted Stock

A summary of the Company’s employee and non-employee restricted-stock activity for the six months ended June 30, 2019 is presented below:

  

Number of

shares

  Weighted-Average Grant-Date Fair Value 
Unvested - December 31, 2018  651,110  $23.65 
Granted  75,000  $     10.97 
Vested (1)  (187,663) $28.83 
Forfeited  (45,000) $22.46 
Unvested – June 30, 2019  493,447  $22.66 

(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.
  

Number of

Shares

  

Weighted-Average

Exercise Price

 
Outstanding – December 31, 2019  4,529,988  $15.26 
Granted  117,632  $2.54 
Exercised  (10,000) $3.12 
Forfeited  (289,061) $17.13 
Outstanding – March 31, 2020  4,348,559  $14.80 
Options exercisable, March 31, 2020  3,584,300  $14.84 

 

Employee Stock Purchase Plan (ESPP)

In May 2018, the Company adopted the Employee Stock Purchase Plan (“ESPP”). The Company has initially reserved 500,000 shares of common stock for purchase under the ESPP. The initial offering period began January 1, 2019 and ended on June 30, 2019 with the first purchase date. Subsequent offering periods will automatically commence on each January 1 and July 1 and will have a duration of six months ending with a purchase date June 30 and December 31 of each year. On each purchase date, ESPP participants will purchase shares of common stock at a price per share equal to 85% of the lesser of (1) the fair market value per share of the common stock on the offering date or (2) the fair market value of the common stock on the purchase date. Total stock-based compensation related to the ESPP for the three and six months ended June 30, 2019 was immaterial to the condensed consolidated financial statements. A total of 7,260 shares of common stock were purchased pursuant to the ESPP during the six months ended June 30, 2019 for total proceeds of $35,000.

 

2217

 

12. INCOME TAXES

Stock-Based Compensation Expense

 

The Company has evaluated its income tax positionsstock-based compensation expense related to stock options, restricted stock awards, and determined that no material uncertain tax positions existed at June 30, 2019. The Company does not expect a significant change in its unrecognized tax benefits within the next twelve months.employee stock purchase plan was as follows (in thousands):

  For the Three Months Ended March 31 
  2020  2019 
General and administrative expense $3,076  $9,037 
Research and development expense  (36)  1,084 
Sales and marketing expense  181   168 
Total stock-based compensation expense $3,221  $10,289 

Restricted Stock

 

A summary of the Company’s employee and non-employee restricted-stock activity is presented below:

Number of

Shares

Unvested - December 31, 20191,843,001
Granted188,944
Vested (1)(452,067)
Forfeited(5,000)
Unvested – March 31, 20201,574,878

(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.

10. Common Stock Warrants

On February 14, 2020, the Company completed an underwritten offering of 10,638,298 shares of its common stock and warrants to purchase 10,638,298 shares of common stock. Each common share and warrant were sold together for a combined public purchase price of $2.35 before underwriting discount and commission. The exercise price of each warrant is $2.80 per share, the warrants were exercisable immediately, and they will expire February 12, 2027. As the warrants could require cash settlement in certain scenarios, the warrants were classified as a liability and are recorded at an estimated fair value using a Monte Carlo simulation model. The total proceeds from the offering were allocated first to the warrant liability based on the estimated fair value with the residual allocated to the common shares. Issuance costs including underwriter commissions and fees paid to third parties were allocated between the warrant liability and common shares on a pro rata basis. The amount allocated to the warrant liability was expensed and the amount allocated to the common shares was recorded as a reduction to additional paid-in-capital. As of June 30, 2019 and DecemberMarch 31, 2018,2020, none of the Company maintained a valuation allowance to fully offset its net deferred tax assets primarily attributable to operations in the United States, as the realization of such assets was not considered more likely than not.warrants had been exercised.

 

The Company files income tax returnschange in fair value of the common stock warrant liability is presented in the U.S. Federalfollowing table and various state and local jurisdictions.is reported as a change in fair value of common stock warrant liability in the statements of operations (in thousands):

  March 31, 2020 
Beginning balance $ 
Initial value of common stock warrant liability  11,677 
Change in fair value of common stock warrant liability  (4,532)
Ending balance $7,145 

18

 

13.11. LOSS PER SHARE

 

The following outstanding potentially dilutive sharessecurities have been excluded from the calculation of diluted net loss per share for the periods presented due to their anti-dilutive effect:

 

 As of June 30,  As of March 31, 
 2019  2018  2020 2019 
Stock options  6,604,461   5,523,068   4,348,559   6,576,816 
Restricted stock  493,447   332,089  1,574,878 516,875 
Common stock warrants 10,638,298  
Shares committed under ESPP 54,632  

 

14.12. 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 Exchange Act 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(the “Consolidated Securities Litigation”), and requested the appointment of the plaintiff inLawi 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 also ordered that the lead plaintiff file and serve a consolidated complaint no later than 60 days after February 1, 2019, the defendants shall have 60 days after filing and service of the consolidated complaint to answer or otherwise respond, and the2019. The lead plaintiff must file a motion for class certification within 90 days of service of the consolidated complaint. The Lead Plaintiff filed a 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 consolidated complaint are without merit, and intends to defend the litigation, vigorously. The Company filed a motion to dismiss the consolidated complaint on June 3, 2019. Plaintiffs’ opposition to the Company’s motion to dismiss was filed on August 2, 2019, and the Company expects to filefiled a reply to the opposition on or about September 13, 2019. A hearing on the Company’s motion to dismiss was held on November 19, 2019; no order has been issued to date. At this early stage of the proceedings the Company is unable to make any prediction regarding the outcome of the litigation.

In November 2018, a shareholder derivative lawsuit was filed in the United States District Court, District of Utah, with the captionMonther v. Lough, et al., case no. 2:18-cv-00791-TC, alleging violations of the Exchange Act, breach of fiduciary duty, and unjust enrichment on the part of certain officers and directors based on the facts and circumstances recited in the Consolidated Securities Litigation. On November 26, 2018, the court issued an order staying all proceedings until after the disposition of motions to dismiss the Consolidated Securities Litigation.

Other Matters

In the ordinary course of business, wethe Company may become involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements, employment, regulatory compliance, and other matters. Except as noted above, at June 30, 2019, we wereMarch 31, 2020, the Company was not party to any legal or arbitration proceedings that may have significantmaterial effects on ourits financial position or results of operations. WeNo governmental proceedings are pending or, to the Company’s knowledge, contemplated against the Company. The Company is not a party to any material proceedings in which any director, member of senior management or affiliate of oursthe Company is either a party adverse to usthe Company or ourits subsidiaries or has a material interest adverse to usthe Company or ourits subsidiaries.

 

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Commitments

 

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

 

15.13. CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

On August 21, 2019, the Company and Dr. Denver Lough, a principal shareholder and former officer and director, signed a settlement terms agreement that provides, in part, that the Company pay to Dr. Lough $1,500,000 in cash on October 1, 2019 and an additional $1,500,000 in cash in equal monthly installments beginning November 1, 2019 and ending April 1, 2021. In addition, the Company agreed to award to Dr. Lough 200,000 restricted stock units that vest in 18 equal monthly installments beginning October 1, 2019. The fair value of the restricted stock units was $0.8 million. The Company expensed the cash portion and equity portion of these awards upon Dr. Lough’s termination. As of March 31, 2020, the Company has recorded a liability of $1.0 million related to future cash payments under the agreement.

 

In October 2018, the Company entered into an office lease covering approximately 7,250 square feet of rental space in the building located at 40 West 57th Street in New York City. The lease is for a term of three years. The annual lease rate is $60 per square foot. Initially the Company will occupyoccupied and paypaid 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. 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.

 

During 2019, the Company increased the space leased from 3,275 square feet to 6,232 square feet. The Company is using 1,648 square feet, and Cohen LLC is using approximately 4,584 square feet as of June 30, 2019.March 31, 2020. The monthly lease payment for 6,232 square feet is $31,160. Of this amount $22,920 is allocatedcharged pro rata to Cohen LLC based on square footage occupied. Additional lease charges for operating expenses and taxes are allocatedalso charged under the sublease based on the ratio of rent paid by the Company and Cohen LLC to total rent. Once the space is fully occupied, the Company will reduce the overall annual lease rate for the Cohen LLC space to $58.60 per square foot. The Company recognized $51,000$69,000 and $126,000$51,000 of sublease income related to this agreement for the three and six months ended June 30,March 31, 2020 and 2019, respectively. The sublease income is included in other income, net in the statement of operations. As of June 30, 2019March 31, 2020 and December 31, 2018,2019, there was $102,000 and $0were no amounts due from the related party under this agreement.

 

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16.14. 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.

 

Certain information concerning ourthe Company’s segments for the three and six months ended June 30, 2019 and 2018 is presented in the following tabletables (in thousands):

 

 For the three months ended For the six months ended  For the Three Months Ended March 31, 
 June 30,  June 30,  2020  2019 
 2019  2018  2019  2018 
Net revenues                
Net revenues:        
Reportable segments:                        
Regenerative medicine $504  $189  $801  $192  $428  $297 
Contract services  822   131   1,990   131   505   1,168 
Total net revenues $1,326  $320  $2,791  $323  $933  $1,465 
                        
Net (loss)/income:                
Net loss:        
Reportable segments:                        
Regenerative medicine $(23,014) $(13,843) $(48,782) $(25,620) $(12,703) $(25,209)
Contract services  222   (157)  417   (157)  (337)  (364)
Total net loss $(22,792) $(14,000) $(48,365) $(25,777) $(13,040) $(25,573)

 

17.15. SUBSEQUENT EVENTS

 

On June 28, 2019, the CompanyApril 12, 2020, our subsidiary PolarityTE MD, Inc. (the “Borrower”) entered into amendmentsa promissory note evidencing an unsecured loan in the amount of employment agreements with$3,576,145 made to it under the members of its OfficePaycheck Protection Program (the “Loan”). The Paycheck Protection Program (or “PPP”) was established under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) and is administered by the U.S. Small Business Administration. The Loan to the Borrower was made through KeyBank, N.A., a national banking association (the “Lender”). The interest rate on the Loan is 1.00%. Beginning seven months from the date of the Chief Executive, which includes Richard Hague, Chief Operating Officer, Paul Mann, Chief Financial Officer,Loan the Borrower is required to make 24 monthly payments of principal and David Seaburg, Presidentinterest in the amount of Corporate Development. Mr. Hague agreed$150,563. The promissory note evidencing the Loan contains customary events of default relating to, reduce his base cash salary by 50% from $370,000among other things, payment defaults, making materially false and misleading representations to $185,000 per year over a two-year period beginning July 1, 2019. Mr. Mann agreed to reduce his base cash salary by 50% from $400,000 to $200,000 per year over a two-year period beginning July 1, 2019. Mr. Seaburg agreed to reduce his base cash salary by 50% from $325,000 to $162,500 per year over a two-year period beginning July 1, 2019. For each of them, after the expirationSBA or Lender, or breaching the terms of the two-year period ending June 30, 2021,Loan documents. The occurrence of an event of default may result in the termrepayment of employment will automatically renew atall amounts outstanding, collection of all amounts owing from the pre-July 1, 2019 salary level unlessBorrower, or filing suit and obtaining judgment against the Company elects to terminateBorrower. Under the agreement by written notice given not less than three months prior to June 30, 2021. In consideration for the agreement by each memberterms of the OfficeCARES Act, PPP loan recipients can apply for and be granted forgiveness for all or a portion of a loan granted under the PPP. Such forgiveness will be determined, subject to limitations, based on the use of loan proceeds for payment of payroll costs and any payments of mortgage interest, rent, and utilities. No assurance is provided that the Borrower will obtain forgiveness of the Chief Executive to reduce his cash salary, the Compensation Committee of the Board of Directors approved granting restricted stock awards to them on July 1, 2019, under the Company’s 2019 Equity Incentive Plan. Mr. Hague’s restricted stock award is for 129,825 common shares that are restricted from transfer by reference to continued employment by the Company, and the restriction on transfer lapses with respect to 10,819 sharesLoan in August 2019 and the remainderwhole or in monthly installments through June 2021. Mr. Mann’s restricted stock award is for 140,351 common shares that are restricted from transfer by reference to continued employment by the Company, and the restriction on transfer lapses with respect to 29,240 shares in December 2019 and the remainder in monthly installments through June 2021. Mr. Seaburg’s restricted stock award is for 114,035 common shares that are restricted from transfer by reference to continued employment by the Company, and the restriction on transfer lapses with respect to 23,814 shares in December 2019 and the remainder in monthly installments through June 2021.part.

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On August 6, 2019, the Company’s Board of Directors approved the grant of restricted stock awards under the 2019 Equity Incentive Plan to Richard Hague, Chief Operating Officer, Paul Mann, Chief Financial Officer, and David Seaburg, President of Corporate Development. Each of them received an award of 175,000 shares that vests in six installments every six months over a period of three years subject to continued employment.

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

 

The following informationdiscussion and analysis below includes certain forward-looking statements that are subject to risks, uncertainties and other factors, as described in “Risk Factors” in our Annual Report on Form 10-K and this report, that could cause our actual growth, results of operations, performance, financial position and business prospects and opportunities for this fiscal year and periods that follow to differ materially from those expressed in or implied by those forward-looking statements. Readers are cautioned that forward-looking statements contained in this Quarterly Report on Form 10-Q should be read in conjunction with our disclosure under the consolidated financial statements and related notes thereto included in this Quarterly Report on Form 10-Q.

In addition to historical information, this report contains forward-looking statements that involve risks and uncertainties that may cause our actual results to 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-Lookingheading “Disclosure Regarding Forward-Looking Statements” included at the beginning of this 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 in historical results and trends. We caution readers not to place undue reliance on any forward-looking statements made by us, which speak only as of the date they are made. We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly 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 will differ from those set forth in the forward-looking statements.below.

 

Overview

 

We 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 operateHistorically, we have operated two segments;segments: the regenerative medicine business segment and the contract research segment.

 

Segment Reporting

 

The regenerative medicine business segment overis engaged in the last year has established and advanced our core “TE” program, which includescommercialization of SkinTE, our first commercial product, SkinTE. The commercial launchvia a sales team, the pursuit of clinical studies of SkinTE, has includedand working on the build outdevelopment of commercial, manufacturing, and corporate structure to support the growthSkin TE Cryo (cryopreservation of SkinTE revenuefor multiple deployments on a single patient), SkinTE POC (point-of-care device for on-site SkinTE processing and deploymentsdeployment), and PTE 11000 (allogenic, biologically active dressing for use in 2019 and beyond. This includes equipment, personnel, systems, and leased properties. Researchwound care). Our commercial and development continue to expand to advanceactivity in the product development pipeline.regenerative medicine business segment includes the maintenance and operation of manufacturing facilities, sales and marketing, and research and development.

 

In May 2018 we acquired assets ofThe contract services segment operates a preclinical research and veterinary sciences business and related real 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 $1.2 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 through our subsidiary, Arches Research, Inc.

Change in Corporate Strategy

We recently announced a change in our strategic focus and a planned change in the regulatory pathway for SkinTE. The change in strategy is the result of a combination of the following unexpected events.

FDA Developments

Following informal, voluntary discussions between us and the United States Food and Drug Administration (FDA), and preliminary views expressed by FDA received on April 21, 2020 regarding the regulatory pathway for SkinTE, the Company believes that it is prudent to submit an investigational new drug application (IND) and thereafter a biologics license application (BLA) for SkinTE. We are in the process of arranging meetings with FDA to determine the most appropriate development plan for a BLA submission. Since 2018 we have been actively engaged in a clinical development program, which includes a completed SkinTE study in burn wounds, ongoing randomized controlled trials (RCTs) in repairing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs), and outcomes data from many of the approximately 700 SkinTE clinical cases. We intend to submit these data to FDA as potential candidates for inclusion in a clinical data package to support a BLA.

FDA has not asked us to stop marketing SkinTE pending submission or approval of a BLA. We plan to discuss with FDA the possibility of continued marketing of SkinTE as a 361 HCT/P on a limited basis at a future meeting, both until November 2020, which marks the end of a 36-month period of enforcement discretion that the Agency announced in final Guidance issued in November 2017 that it would generally observe unless there are reported or potential significant safety concerns, and beyond November 2020. It is not customary for the FDA to allow wide-spread commercial sales of a product subject to a pending BLA.

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COVID-19 Pandemic

In December 2019, there was an outbreak of a new strain of coronavirus (“COVID-19”). In March 2020, the World Health Organization declared COVID-19 a pandemic. Rapid growth of the pandemic soon followed in the United States. Throughout the country, healthcare assets in terms of facilities and providers have been marshalled and dedicated to the care and treatment of COVID-19 patients while still trying to meet the acute and traumatic care needs of the general population. Consequently, medical care and procedures that are considered “elective” have been put on hold in many regions across the country. Many of the initial economic effects in the healthcare industry of the early stages of the COVID-19 outbreak in the United States and the shift in healthcare resources occurred during the last three weeks of the quarter ended March 31, 2020. The number of paid SkinTE cases in the first quarter of 2020 was 81 compared to 89 paid cases in the fourth quarter of 2019. The number of paid cases were impacted during the last three weeks of March, and we offer underobserved that some SkinTE procedures planned for April were postponed, cancelled, or not scheduled as a direct result of the trademark POLARITYRD. ContractCOVID-19 pandemic. The impact is most evident in chronic wounds without amputation risk. The Company anticipates continued postponement of elective procedures through the second quarter and it is not possible to predict the impact of a second wave of COVID-19 that might occur in the fall or winter.

Moving Forward

Given the Company’s recent decision to change the regulatory pathway for SkinTE with the FDA, and the headwinds associated with the COVID-19 pandemic, management has determined the best use of the Company’s capital resources going forward is to focus on the preparation and prosecution of an IND and then a BLA with the FDA. We believe a BLA will enhance the value of SkinTE as a product and increase the likelihood of achieving widespread commercial adoption. We believe this pathway will align more clearly with our goal of delivering to healthcare providers additional data to establish SkinTE as the standard of care for chronic and traumatic wounds. In connection with pursuing this strategy, over the next several months we will substantially decrease commercial operations and other functions to reduce historical monthly cash burn and redirect our capital resources to advancing our IND and BLA submissions.

Revenue Recognition

In the regenerative medicine products segment, we record product revenues primarily from the sale of its regenerative tissue products. We sell our products to healthcare providers, primarily through direct sales representatives. Product revenues consist of a single performance obligation that we satisfy at a point in time. In general, we recognize product revenue upon delivery to the customer. In the contract services segment, we earn service revenues from the provision of contract research services, help us defraywhich includes delivery of preclinical studies and other research services to unrelated third parties. Service revenues generally consist of a single performance obligation that we satisfy over time using an input method based on costs incurred to date relative to the total costs of maintaining a first-rate research facility and allow usexpected to meet companies pursuing new technologies that may be opportunities for collaborative or strategic relationships going forward.required to satisfy the performance obligation.

 

Research and Development Expenses.Expenses

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

 

General and Administrative Expenses.Expenses

General and administrative expenses primarily represent employee related costs, including stock compensation for corporate executiveexecutives 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, and corporate and business development initiatives.

Sales and Marketing Expenses

Sales and marketing expenses primarily represent employee related costs, including stock compensation for sales and marketing executives and staff, marketing and advertising expenses, trade shows and other promotional costs, and other related charges.

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Results of Operations

Comparison of the three months ended March 31, 2020 compared to the three months ended March 31, 2019.

  For the Three Months Ended  Increase
(Decrease)
 
(in thousands) March 31, 2020  March 31, 2019  Amount  % 
  (Unaudited)       
Net revenues                
Products $428  $297  $131   44%
Services  505   1,168   (663)  (57)%
Total net revenues  933   1,465   (532)  (36)%
Cost of sales                
Products  340   273   67   25%
Services  176   503   (327)  (65)%
Total cost of sales  516   776   (260)  (34)%
Gross profit  417   689   (272)  (39)%
                 
Operating costs and expenses                
Research and development  3,373   5,352   (1,979)  (37)%
General and administrative  11,057   17,195   (6,138)  (36)%
Sales and marketing  3,694   3,953   (259)  (7)%
Total operating costs and expenses  18,124   26,500   (8,376)  (32)%
Operating loss  (17,707)  (25,811)  8,104   31%
Other income (expense)                
Change in fair value of common stock warrant liability  4,532      4,532   * 
Interest income, net  (12)  70   (82)  (117)%
Other income, net  147   168   (21)  (13)%
Net loss $(13,040) $(25,573) $12,533   49%

Net Revenues

For the three-month period ended March 31, 2020, we recorded net revenues of $0.93 million, which represents a decrease of $0.53 million or 36% from the $1.47 million of net revenues recorded for the three months ended March, 31, 2019. The $0.53 million decrease in net revenues was due to decreased revenue in our contract services operating segment from lower demand in the first quarter of 2020, which was partially offset by an increase in product revenue.

Gross Profit

Cost of sales for the product segment as a percentage of net revenues was 19% in the first quarter of 2019 compared to 36% for the first quarter of 2020. The increase is driven by a higher percentage of variable cost per unit due to smaller case sizes. Cost of sales for the services segment as a percentage of net revenues was 34% in the first quarter of 2019 compared to 19% for the first quarter of 2020, which we attribute to variations in service specific materials requirements for performing services in the first quarter of 2020 compared to the same quarter in 2019. As a result of the changes in net revenues and cost of sales in both segments, the combined effect is that gross profit decreased as a percentage in line with net revenues period over period from $0.69 million for the three-month period ended March 31, 2019 to $0.42 million for the three-month period ended March 31, 2020, or a decrease in gross profit of 39%.

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Research and Development

For the three-month period ended March 31, 2020, we recorded research and development expenses totaling $3.37 million, which represents a decrease of $1.98 million, or 37%, from $5.35 million of research and development expenses for the three months ended March 31, 2019. There was a reduction in staff in research and development that reduced compensation and benefits costs by $.72 million and stock compensation expense decreased $1.12 million.

General and Administrative Expenses

General and administrative expenses totaled $11.06 million for the three-month period ended March 31, 2020, which represents a decrease of $6.14 million as compared to $17.20 million of general and administrative expenses incurred during the three months ended March 31, 2019. The primary driver for this decrease is a $5.96 million reduction in stock compensation expense in the first quarter of 2020 compared to the first quarter of 2019.

Sales and Marketing

Sales and marketing expenses totaled $3.69 million for the three-month period ended March 31, 2020, compared to $3.95 million of sales and marketing expenses incurred during the three months ended March 31, 2019, which is roughly equivalent and consistent with the SecuritiesCompany’s focus on commercialization of SkinTE in both periods. The service segment does not have a meaningful sales and Exchange Commission (SEC)marketing component to its business.

Liquidity and Capital Resources

As of March 31, 2020, our cash and cash equivalents and short-term investments totaled $39.51 million and our working capital was approximately $31.93 million, compared to cash and cash equivalents and short-term investments of $29.24 million and our working capital of approximately $22.43 million at December 31, 2019. Our accumulated deficit at March 31, 2020, was approximately $448.40 million.

On April 12, 2020, our subsidiary PolarityTE MD, Inc. (the “Borrower”) entered into a promissory note evidencing an unsecured loan in the amount of $3,576,145 made to us under the Paycheck Protection Program (the “Loan”). The Paycheck Protection Program (or “PPP”) was established under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) and is administered by the U.S. Small Business Administration. The Loan to the Borrower was made through KeyBank, N.A., a national banking association (the “Lender”). The interest rate on the Loan is 1.00%. Beginning seven months from the date of the Loan the Borrower is required to make 24 monthly payments of principal and corporate-interest in the amount of $150,563. The promissory note evidencing the Loan contains customary events of default relating to, among other things, payment defaults, making materially false and business-development initiatives.misleading representations to the SBA or Lender, or breaching the terms of the Loan documents. The occurrence of an event of default may result in the repayment of all amounts outstanding, collection of all amounts owing from the Borrower, or filing suit and obtaining judgment against the Borrower. Under the terms of the CARES Act, PPP loan recipients can apply for and be granted forgiveness for all or a portion of a loan granted under the PPP. Such forgiveness will be determined, subject to limitations, based on the use of loan proceeds for payment of payroll costs and any payments of mortgage interest, rent, and utilities. No assurance is provided that the Borrower will obtain forgiveness of the Loan in whole or in part.

On February 14, 2020, we completed an underwritten offering of 10,638,298 shares of our common stock and warrants to purchase 10,638,298 shares of common stock. Each common share and warrant were sold together for a combined public purchase price of $2.35 before underwriting discount and commission. Each warrant has an exercise price of $2.80 per share, was exercisable immediately, and will expire February 12, 2027. The net proceeds to the Company from the offering were $22.5 million, after offering expenses payable by the Company. In connection with this offering, the Company agreed not to sell any additional shares under the Keystone Purchase Agreement described below for a period of 90 days after the closing date of the offering.

 

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We are party to an Equity Purchase Agreement dated as of December 5, 2019 (the “Purchase Agreement”), with Keystone Capital Partners, LLC (“Keystone”), pursuant to which Keystone has agreed to purchase from us up to $25.0 million of shares of our common stock, subject to certain limitations including a minimum purchase price of $2.00 per share, at our direction from time to time during the 36-month term of the Purchase Agreement. Concurrently, we entered into a Registration Rights Agreement with Keystone, pursuant to which we agreed to register the sales of our common stock pursuant to the Purchase Agreement under our existing shelf registration statement on Form S-3 or a new registration statement. During the period from the date of the Purchase Agreement to the date of this filing, we have sold 270,502 shares of our common stock under the Purchase Agreement generating total gross proceeds of $725,000 and have up to $24,275,000 available for future sale under the Purchase Agreement. In connection with the underwritten offering described in the preceding paragraph, we agreed not to sell any additional shares under the Purchase Agreement for a period of 90 days after the closing date of the offering.

Based upon the current status of our product development plans, we believe that our existing cash and cash equivalents, with planned operating cost reductions, will be adequate to satisfy our capital and operating needs for at least the next 12 months from the date of filing. This conclusion is based on our current capital resources and plans for implementing operating cost reductions. We believe we may need additional financing to continue clinical trials for SkinTE and development of our other product candidates. 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, we may be required to delay, reduce the scope of, or eliminate one or more of our product development programs or be unable to continue operations over a longer term. We plan to meet our future capital requirements primarily through issuances of equity securities, debt financing, or strategic partnership arrangements. Failure to generate revenue or raise additional capital would adversely affect our ability to achieve our intended business objectives

Our actual capital requirements will depend on many factors, including the cost and timing of pursuing a biologics license application for SkinTE we intend to file with FDA; 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 for our product candidates. Our forecast of 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, Item 1A, “Risk Factors” in Part II of this Report on Form 10-Q 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. If we elect to pursue collaborative arrangements, the terms of such arrangements may require us to relinquish rights to certain of our technologies, products or marketing territories. Our failure to raise additional 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.

The following table sets forth the primary sources and uses of cash for each period indicated:

  Three Months Ended 
(in thousands) March 31, 2020  March 31, 2019 
Net cash provided by (used in)        
Operating activities $(13,854) $(15,968)
Investing activities  16,973   (5,059)
Financing activities 25,180   302 
Net increase/(decrease) in cash and cash equivalents $28,299  $(20,725)

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Income Taxes.Cash used in operating activities Income taxes consist

During the three-month period ended March 31, 2020, net cash used in operating activities was $13.85 million, which included $1.16 million of our provisions for income taxes, as affected by our netissuance fees related to the February raise. The cash used in operating loss carryforwards. Future utilization of our net operating loss, or NOL, carryforwards may be subjectactivities was due to a substantial annual limitationnet loss of $13.04 million adjusted by $4.53 million due to the “change in ownership” provisionsremeasurement of the Internal Revenue Code. The annual limitation may resultwarrant liability arising from the underwritten offering of common stock and warrants in February 2020, which was offset by the expirationnon-cash expenses of NOL carryforwards before utilization. Due$3.22 million for stock compensation expense.

During the three-month period ended March 31, 2019, net cash used in operating activities was $15.97 million, which was due to our historya net loss of losses, a valuation allowance sufficient$25.57 million offset primarily by the non-cash expenses of $10.29 million for stock compensation expense

Cash provided by (used in) investing activities

During the three-month period ended March 31, 2020, net cash provided by investing activities was $16.97 million, which was due primarily to fullyproceeds from the sale and maturities of available for sale securities.

During the three-month period ended March 31, 2019, net cash used in investing activities was $5.06 million, which was due primarily due to purchases of available for sale securities.

Cash provided by financing activities

During the three-month period ended March 31, 2020, net cash provided by financing activities was $25.18 million due to proceeds from financing arrangements and net proceeds received from sale of common stock and warrants.

During the three-month period ended March 31, 2019, net cash provided by financing activities was $0.30 million primarily from proceeds received from stock option exercises of $0.53 million offset our NOLby payment of contingent liabilities of $0.11 million 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.principal payments on financing leases of $0.12 million.

 

Critical Accounting Policies and Estimates

For a description of our significant accounting policies, see note 2 to our condensed consolidated financial statements.

 

Our discussion and analysis of the financial condition and results of operations is based upon our condensed 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 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 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 areis the valuationextent of warrant liability, valuationprogress toward completion of derivative liability,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.

 

We have identifiedRevenue Recognition

Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the policies below as criticalconsideration which the entity expects to our business operations andreceive 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 understandingperformance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation.

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In the regenerative medicine products segment, the Company records product revenues primarily from the sale of our financial results.its regenerative tissue products. The impactCompany sells its products to healthcare providers, primarily through direct sales representatives. Product revenues consists of a single performance obligation that the Company satisfies at a point in time. In general, the Company recognizes product revenue upon delivery to the customer.

In the contract services segment, the Company records service revenues from the sale of its contract research services, which includes delivery of preclinical studies and any associated risks relatedother research services to these policiesunrelated third parties. Service revenues generally consist of a single performance obligation that the Company satisfies over time using an input method based on our business operationscosts 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 over the term of the performance 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 discussed throughout management’s discussiondue upfront and analysisthe remainder upon completion of financial conditionthe contract, with most contracts completing in less than a year.

Costs to obtain the contract are incurred for products revenues as they are shipped and results of operations when such policies affect our reported and expected financial results.are expensed as incurred.

 

GoodwillStock Based Compensation

The Company measures all stock-based compensation using a fair value method and Intangible Assets.Goodwill represents the excess acquisition costrecords such expense in research and development, general and administrative, and sales and marketing expenses. Compensation expense for stock options with graded vesting is recognized over the service period for each separately vesting tranche of the award as though the award were in substance, multiple awards.

The fair value for options issued is estimated at the date of net tangible and intangible assets acquired. Goodwillgrant using a Black-Scholes option-pricing model. The risk-free rate is not amortized and is subject to annual impairment testing or between annual tests if an event or changederived from the U.S. Treasury yield curve in circumstance occurs that would more likely than not reduceeffect at 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, the first steptime of the two-step process must be performed.grant. The goodwill impairment testvolatility factor 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 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,determined based on the excess of a reporting unit’s carrying amount over its fair value.Company’s historical stock prices. Forfeitures are recognized as they occur.

 

The fair value of reporting unitsrestricted stock grants is measured based on widely accepted valuation techniques thatthe 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.

Accruals for Research and Development Expenses and Clinical Trials

As part of the process of preparing its financial statements, the Company believes market participants would use, althoughis required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment terms that do not match the valuation process requires significant judgmentperiods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate expenses in its financial statements by matching those expenses with the period in which services are performed and often involves the use of significant estimates and assumptions.efforts are expended. The Company utilizesaccounts for these expenses according to the timing of various aspects of the expenses. The Company determines accrual estimates by taking into account discussion with applicable personnel and outside service providers as to the progress of clinical trials, or the services completed. During the course of a market cap approach in estimatingclinical trial, the fair valueCompany adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting units. Theof contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and assumptions used in determining fair value could have a significant effect on whether or not an impairment charge is recordedtiming of services performed relative to the actual status and the magnitudetiming of such a charge. Adverse market or economic events couldservices performed may vary and may result in impairment charges in future periods.

Intangible assets deemed to have finite livesit reporting amounts that 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,too high or indirectly, to its future cash flows. Intangible assets are reviewedtoo low 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.any particular period.

 

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Impairment of Long-Lived Assets.Assets

The Company reviews long-lived assets, including property and equipment, intangible assets and goodwill 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.There were no impairments of long-lived assets for any of the periods presented.

 

Income Taxes.Common Stock and Warrant Transactions

The Company accounts for income taxes underissued units consisting of common stock and warrants and subsequently remeasured those warrants at fair value. Determining the assetfair value of the securities in these transactions requires significant judgment, including adjustments to quoted share prices and liability method. Deferred tax assetsexpected stock volatility. Such estimates may significantly impact our results of operations and liabilities are recognized for the future tax consequences attributablelosses applicable 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.common stockholders.

Disclosure Regarding Forward-Looking Statements

 

Stock Based Compensation. The Company measures all stock-based compensation using a fair value method and records such expenseStatements that are not historical facts contained in research and development, general and administrative and sales and marketing expenses. Compensation Expense for stock options with graded vesting is recognized over the service period for each separately vesting tranche 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 the 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 Company 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 relative to the total costs expected to be required to satisfy the performance obligation.

Leases.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 leases 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 whether or not the lease is effectively a financed purchaseincorporated 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. 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 the notes to the condensed consolidated financial statements included in Part I, Item 1, ofreference into this Quarterly Report on Form 10-Q for additional information regardingare “forward-looking statements” within the adoption.meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements involve risks and uncertainties that could cause actual results to differ from projected results. The words “anticipate,” “goal,” “seek,” “project,” “strategy,” “future,” “likely,” “may,” “should,” “will,” “believe,” “estimate,” “expect,” “plan,” “intend” and similar expressions and references to future periods, as they relate to us, are intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are subject to certain risks, uncertainties and assumptions. We cannot assure you that any of our expectations will be realized. Forward-looking statements include, among others, statements we make regarding:

the timing or success of obtaining regulatory licenses or approvals for marketing our products;
the initiation, timing, progress, and results of our research and development programs;
the initiation, timing, progress, and results of our clinical trials;
the timing for the healthcare industry to resume performing elective procedures that may impact the timing and cost of clinical trials;
the impact of new accounting pronouncements;
size and growth of our target markets;
sufficiency of our working capital to fund our operations for the next 12 months;
infrastructure required to support operations in future periods, including the expected costs thereof;
estimates associated with revenue recognition, asset impairments, and cash flows;
variance in our estimates of future operating costs;
future vesting and forfeitures of compensatory equity awards;
the effectiveness of our disclosure controls and our internal control over financial reporting; and
our plans to remediate material weaknesses in our internal control over financial reporting.

Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, without limitation:

the ability to comply with regulations applicable to the manufacture, marketing, sale and distribution of our products;
the ability to gain adoption by healthcare providers of our products for patient care;
the ability to manufacture product to meet demand;
the acceptance and level of reimbursement to healthcare providers for application of our products by public and private payors;

 

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 the scope of protection we can establish and maintain for intellectual property rights covering our product candidates and technology;
developments relating to our competitors and industry;
the development of new therapies or new discoveries that render our products obsolete;
outbreaks of disease, including the COVID-19 pandemic, and related stay-at-home orders, quarantine policies and restrictions on travel, trade and business operations;
political and economic instability, whether resulting from natural disasters, wars, terrorism, pandemics or other sources;
decisions made by healthcare providers regarding elective procedures and use of facilities and resources when there is a major outbreak of life-threatening infectious disease, such as COVID-19;
the ability to pursue sales activity in the healthcare industry when there is a major outbreak of life-threatening infectious disease, such as COVID-19;
the ability to manufacture and deliver our products if employees are quarantined due to the impact of the COVID-19;
the ability to find and retain skilled personnel;
the need for, and ability to obtain, additional financing in the future;
general economic conditions;
inaccuracies in estimates of our expenses, future revenues, and capital requirements;
future accounting pronouncements;
unauthorized access to confidential information and data on our information technology systems and security and data breaches; and
factors described under “Risk Factors” in our 2019 Annual Report on Form 10-K and under Item 1A of this Quarterly Report on Form 10-Q.

 

ResultsWe undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of Operations

Three months ended June 30, 2019 versus three months ended June 30, 2018

Net Revenues. For the three-month period ended June 30, 2019, total net revenues were $1.3 million. Products revenues from the sale of SkinTE were $0.5 million for the three months ended June 30, 2019 compared to $0.2 million for the three months ended June 30, 2018. Net revenues from services for the three months ended June 30, 2019 were $0.8 million from the contract research segment operations driven primarilynew information, future events or otherwise. All forward-looking statements are expressly qualified by the IBEX preclinical research business. The IBEX business was acquired in May 2018 and contributed $0.1 million to revenue in the three-months ending June 30, 2018.these cautionary statements.

Cost of Sales. For the three-month period ended June 30, 2019, total cost of sales was approximately $0.6 million and approximately 45% of total net revenues. Products cost of sales were $0.3 million or 68% of products revenues primarily due to fixed overhead costs. Services cost of sales were $0.3 million or 31% of services revenues. Product cost of sales for the three-month period ended June 30, 2018 were $0.1 million or 66% of products revenues. Services cost of sales for the three-month period ended June 30, 2018 were $0.04 million or 31% of services revenues.

Research and Development Expenses. Research and development expenses increased $1.8 million, or 63%, in the three-month period ended June 30, 2019, compared to the three-month period ended June 30, 2018. The increase is primarily driven by an increase in research and clinical support personnel with associated wage and benefits cost year over year.

General and Administrative Expenses. General and administrative expenses increased $3.8 million, or 33%, in the three-month period ended June 30, 2019 compared to the three-month period ended June 30, 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 June 30, 2019, sales and marketing expenses were $4.0 million. This represents sales personnel and marketing costs primarily driven by the commercialization of SkinTE. There were no sales personnel and marketing costs during the three-month period ended June 30, 2018.

Other Income (Expenses). For the three-month period ended June 30, 2019, other income (expenses) increased $0.2 million or 455% compared to the three-month period ended June 30, 2018. This increase was due to an increase of other income driven by investment income and rental income.

Net loss. Net loss for the three-month period ended June 30, 2019 was approximately $22.8 million compared to a net loss of approximately $14.0 million for the three-month period ended June 30, 2018, primarily reflecting the increase in operating costs and expenses driven by expanding operations discussed above.

Six months ended June 30, 2019 versus six months ended June 30, 2018

Net Revenues. For the six-month period ended June 30, 2019, total net revenues were $2.8 million. Products revenues from the sale of SkinTE were $0.8 million for the six months ended June 30, 2019 compared to $0.2 million for the six months ended June 30, 2018. Net revenues from services were $2.0 million from the contract research segment operations driven primarily by the Ibex preclinical research business. The IBEX business was acquired in May 2018 and contributed $0.1 million to revenues in the six months ending June 30, 2018.

Cost of Sales. For the six-month period ended June 30, 2019, total cost of sales was approximately $1.4 million and approximately 49% of total net revenues. Products cost of sales were $0.6 million or 77% of products revenues primarily due to fixed overhead costs. Services cost of sales were $0.8 million or 38% of services revenues. Products cost of sales for the six-month period ended June 30, 2018 were $0.1 million.

Research and Development Expenses. Research and development expenses increased $1.6 million, or 19%, in the six-month period ended June 30, 2019, compared to the six-month period ended June 30, 2018. The increase is primarily driven by an increase in research and clinical support personnel with associated wage and benefits cost, offset by a shift in mix between commercial and operational infrastructure build out in the current period as well as research and development costs in the prior period.

General and Administrative Expenses. General and administrative expenses increased $13.4 million, or 71%, in the six-month period ended June 30, 2019 compared to the six-month period ended June 30, 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 six-month period ended June 30, 2019, sales and marketing expenses were $7.9 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 six-month period ended June 30, 2018.

Other Income (Expenses). For the six-month period ended June 30, 2019, other income (expenses) decreased $0.9 million or 63% compared to the six-month period ended June 30, 2018. This decrease was primarily driven by a change in the fair value of derivatives of $1.9 million recorded, offset by loss on extinguishment of warrant liability of $0.5 million in the six months ended June 30, 2018. There were no warrants outstanding for the six-month period ended June 30, 2019.

Net loss. Net loss for the six-month period ended June 30, 2019 was approximately $48.4 million compared to a net loss of approximately $25.8 million for the six-month period ended June 30, 2018, primarily reflecting the increase in operating costs and expenses driven by expanding operations discussed above.

Liquidity and Capital Resources

As of June 30, 2019, our cash, cash equivalents and short-term investments balance was approximately $58.2 million and our working capital was approximately $52.6 million, compared to cash and cash equivalents and short-term investments of $61.8 million and working capital of $56.8 million at December 31, 2018.

As reflected in the condensed consolidated financial statements, we had an accumulated deficit of approximately $391.2 million at June 30, 2019, and approximately $28.8 million net cash used in operating activities for the six-month period then ended. At December 31, 2018, we had an accumulated deficit of approximately $342.9 million and approximately $10.8 million net cash used in operating activities for the six-months ended June 30, 2018.

On April 10 and May 6, 2019, the Company completed an underwritten offering 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 $27.9 million, after deducting offering expenses payable by the Company.

The Company has taken numerous steps to further reduce its cash burn during the three months ended June 30, 2019, including outsourcing various aspects of our business, conducting a thorough budget review by department, enhancing fiscal discipline and prioritizing resource allocation to those areas of the business that are most likely to generate revenue in the near term.

Based upon the current status of our product development and commercialization plans, we believe that our existing cash, 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. Nevertheless, it is likely in the future we may need additional financing to continue clinical deployment and commercialization of our TE products, development of our other product candidates, and scaling the manufacturing capacity for our products and product candidates. 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 operational 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 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 statements 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 Part I, Item 1A. Risk Factors of our Transition Report on Form 10-K filed with the 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. If we elect to pursue collaborative arrangements, 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.

Off-Balance Sheet Arrangements

As of June 30, 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, cash equivalents and short-term investments were approximately $58.2 million as of June 30, 2019, compared to cash and cash equivalents and short-term investments of approximately $61.8 million as of December 31, 2018. Working capital was approximately $52.6 million as of June 30, 2019, compared to working capital of approximately $56.8 million as of December 31, 2018.

Operating Cash Flows

Cash used in operating activities for the six-month period ended June 30, 2019, was approximately $28.8 million. Approximately $10.8 million of cash was used in operating activities for the six-month period ended June 30, 2018. The increase in net cash used in operating activities mostly relates to the expansion of infrastructure and sales and marketing expenses related to the commercial launch of SkinTE.

Investing Cash Flows

Cash used in investing activities for the six-month period ended June 30, 2019, was approximately $8.3 million. Cash used in investing activities for the six-month period ended June 30, 2018 amounted to approximately $6.4 million. For the six-month period ended June 30, 2019, the activity relates to the net purchase of available-for-sale securities and the purchase of property and equipment. For the six-month period ended June 30, 2018, the activity relates to the purchase of property and equipment and the acquisition of IBEX.

Financing Cash Flows

Net cash provided by financing activities for the six-month period ended June 30, 2019, was approximately $27.3 million. $92.7 million of cash was provided by financing activities for the six-month period ended June 30, 2018. For the six-month period ended June 30, 2019, the activity relates to proceeds from stock options exercised and the Company completed an underwritten offering 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 $27.9 million, after deducting offering expenses payable by the Company, offset by principal payments on finance leases and contingent consideration liability payments. For the six-month period ended June 30, 2018, the activity relates to a public offering of 2,335,937 shares of our common stock at an offering price of $16.00 per share, resulting in net proceeds of $34.6 million, after deducting offering expenses and another 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.

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 principal executive and financial officers, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Based on the evaluation of the effectiveness of our disclosure controls and procedures as of June 30, 2019,March 31, 2020, our principal executive and financial officers concluded that, as of such date, our disclosure controls and procedures were not effective due to the material weaknessesweakness in our internal control over financial reporting identified below. To address the material weaknesses,weakness, 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 or 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 all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control.

TwoThe material weaknessesweakness previously identified as of December 31, 2018,2019, continued to exist as of June 30,March 31, 2020. In 2019, which include (1) insufficient internalwe failed to execute controls relating to reconciliation procedures. In addition, we did not have a sufficient level of precision in our review procedures to detect potentially material errors in accrual and related accounts.

In the first quarter of 2020 management implemented a systemic tool to information technology general controlsenhance the reconciliation and review procedures identified in the areasmaterial weakness above. The tool has not been in operation for a sufficient period 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 to Internal Control over Financial Reporting

During the second quarter of 2019, we completed the integration of IBEX onto our Enterprise Resource Planning platform thereby enhancing accounting systems and controls.time required for remediation. There were no other significant changes in the Company’s internal control over financial reporting during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

We have taken several steps to remediate the 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 and we continue to run parallel tests, including data reconciliations. 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 continue to evaluate and work to improve our internal control over financial reporting, management may determine to take additional measures to address the material weaknesses or determine to modify the remediation plan described above.weakness. 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 exist.

 

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PART II. OTHER INFORMATION

Item 1. Legal Proceedings

 

On June 26, 2018,Item 1A. Risk Factors

You should carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which could materially affect our business, financial position, or future results of operations. The risks described in that Annual Report are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial position, or future results of operations. The risk factors set forth below update, and should be read together with, the risk factors described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019.

Risks Related to Our Business

Public health crises, or the perception of their effects, have had and could continue to have a class action complaint alleging violationsmaterial adverse effect on our business and results of operations.

We could be negatively impacted by the widespread outbreak of an illness or any other communicable disease, such as the COVID-19 pandemic, or any other public health crisis that results in economic and healthcare industry disruptions. The COVID-19 pandemic has negatively impacted the global economy, disrupted supply chains and workforce participation due to “shelter-in-place” restrictions by various governments, and created significant volatility and disruption of financial markets. To date, COVID-19 has had, and may continue to have, an adverse impact on our product sales and commercial operations. We have experienced and may continue to experience significant and unpredictable reductions in the demand for our product as healthcare customers devote medical resources and priorities to the treatment of COVID-19. Our customers may delay their customary purchasing and contracting practices during the healthcare crisis, which could contribute to the reduction in demand for our product. In addition, the American College of Surgeons, U.S. surgeon general, and other public health bodies have recommended delaying elective surgeries during the COVID-19 pandemic, and surgeons and medical societies are evaluating the risks of minimally invasive surgeries in the presence of infectious diseases, which we expect will continue to negatively impact the sale of our product.

The extent of the Federal securities laws was filedimpact of the COVID-19 pandemic on our operational and financial performance, including our ability to execute our business strategies and initiatives in the expected time frame, will depend on future developments, including the duration and spread of the pandemic and the effect on healthcare providers and the healthcare industry; our ability to travel, distribute, and deploy SkinTE, as well as reduction in access to our customers due to stay-at-home orders, quarantine policies and restrictions on travel, trade, and business operations. These unprecedented measures to slow the spread of the virus taken by local governments and health care authorities, including the deferral of elective medical procedures and social distancing measures, will adversely affect our operations and financial results.

In addition, the COVID-19 pandemic has adversely affected, and may continue to adversely affect, the economies and financial markets of many countries, which may result in a period of regional, national, and global economic slowdown or regional, national, or global recessions that could affect decisions on healthcare spending, adversely affect the healthcare industry, and adversely affect access to capital. COVID-19 and the current financial, economic, and capital markets environment, and future developments in these and other areas present material uncertainty and risk with respect to our performance, financial condition, volume of business, results of operations, and cash flows. Due to the uncertain scope and duration of the pandemic and uncertain timing of national recovery and economic normalization, we are unable to estimate the impact on our operations and financial condition.

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Our wholly owned subsidiary accepted a loan under the CARES Act pursuant to the Paycheck Protection Program, or the PPP, and the loan may not be forgiven or may subject us to challenges, audits, or investigations regarding qualification for the loan, any of which could reduce our liquidity and have a material adverse effect on our business, financial condition and results of operations.

On April 12, 2020, our subsidiary PolarityTE MD, Inc. (the “Borrower”) entered into a promissory note offered by a bank (the “Lender”) evidencing an unsecured loan in the amount of $3,576,145 made to the Borrower under the PPP (the “Loan”). The PPP was established under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) and is administered by the U.S. Small Business Administration (the “SBA”). The interest rate on the Loan is 1.00%. Beginning seven months from the date of the Loan the Borrower is required to make 24 monthly payments of principal and interest in the amount of $150,563. The promissory note evidencing the Loan contains customary events of default relating to, among other things, payment defaults, making materially false and misleading representations to the SBA or Lender, or breaching the terms of the Loan documents. The occurrence of an event of default may result in the repayment of all amounts outstanding, collection of all amounts owing from the Borrower, or filing suit and obtaining judgment against the Borrower. Under the terms of the CARES Act, PPP loan recipients can apply for and be granted forgiveness for all or a portion of a loan granted under the PPP. Such forgiveness will be determined, subject to limitations, based on the use of loan proceeds for payment of payroll costs and any payments of mortgage interest, rent, and utilities.

No assurance is provided that the Borrower will elect to pursue forgiveness of all or a portion of the Loan or be eligible for and obtain forgiveness of all or a portion of the Loan. If the Borrower elects not to pursue or is unable to qualify for or obtain forgiveness of all or a portion of the Loan, our liquidity could be reduced and our business, financial condition and results of operations may be adversely affected.

Pursuant to the requirements under the CARES Act, in connection with the Loan, the Borrower certified that current economic uncertainty makes the Loan request necessary to support the ongoing operations of the Borrower. We believe that the Borrower made such certification in a manner consistent with SBA guidance that borrowers must make the certification in good faith, taking into account their current business activity and their ability to access other sources of liquidity sufficient to support their ongoing operations in a manner that is not significantly detrimental to the business. While we believe the Borrower’s prior and future certifications were and will be well supported on the dates certified, in light of the understandings of the requirements and the assessment made on the certification date, we cannot be certain that SBA or any other governmental entity or third party will concur with the Borrower, especially in light of the press scrutiny and SBA’s evolving guidance and views, our change in strategy triggered, in part, on regulatory developments occurring after the Loan was made, and the eventual extent of the impact of current economic uncertainties on Borrower’s operations. Further, we cannot be certain that, as a subsidiary of a public company, the Borrower might not be deemed to have improperly made the required certifications, including that current economic uncertainty makes the loan request necessary to support the ongoing operations of the Borrower, taking into account the Borrower’s current business activity and ability to access other sources of liquidity sufficient to support its ongoing operations in a manner that is not significantly detrimental to the business.

Subsequent to the Borrower’s application for the loan, SBA issued various interpretive guidelines in connection with the PPP, including guidance on how SBA interprets certain of the certification requirements. One of the interpretations appears to be in response to various press reports that well-established or well capitalized private and public companies were able to secure PPP loans that were meant for smaller companies. SBA’s interpretive guidelines published on April 23, 2020 set forth that public companies with substantial market value and access to capital markets would likely not qualify to participate in the PPP and SBA advised any such public company to be prepared to provide the basis for the certifications upon SBA request. Subsequently, on April 28, 2020 the Secretary of the Treasury and SBA announced that the government will conduct a full audit of all PPP loans of more than $2 million for which the borrower applies for forgiveness. As the Borrower expects it will be audited or reviewed by SBA or the U.S. Department of the Treasury if it files an application for forgiveness, and, whether or not it elects to seek forgiveness of all or part of the loan, it could be subject to investigation, audit or other review by governmental agencies or claims by third parties, with respect to whether it qualified for an SBA loan, or whether the certifications it made to obtain the Loan are accurate, or other matters. There is a risk that any such audit, review, investigation or claim could result in the diversion of our management’s time and attention, the need to incur significant legal expenses and the possibility that we will sustain reputational injury. If the Borrower were to be audited, investigated, reviewed or subject to suit and if there is any adverse finding in such audit, investigation, review or suit or if the Borrower were alleged, or determined, not to qualify for the Loan or alleged, or found, to have made false certifications in connection with the Loan, the Borrower could be required to return the full amount of the Loan, which would reduce its liquidity, and would subject it to fines and penalties, and exclusion from government contracts. In particular, the Borrower may become subject to actions under the federal False Claims Act, or the FCA, including its qui tam provisions, which, among other things, prohibits persons from knowingly filing, or knowingly causing to be filed, a false statement, or knowingly using a false statement, to obtain payment from the federal government. Violations of the FCA are subject to treble damages and penalties. In the case of an SBA loan, the government could allege that single damages are the amount of the loan and interest thereon (or more), which under the FCA could then be trebled. Substantial penalties must also be imposed for each submitted false statement when a defendant loses an FCA trial. FCA cases may be initiated by the U.S. Department of Justice or by private persons or entities, often called “whistleblowers,” who bring the action on behalf of the United States District Court, DistrictStates. The Borrower may also face enforcement arising under other federal statutes, including criminal laws, and administrative actions and investigations initiated by SBA or other governmental entities. Furthermore, if the Borrower is identified as an entity that the media, government officials or others seek to portray as a business that should not have availed itself of Utah,PPP funding, the Borrower may face negative publicity, which could have a materially adverse impact on its business and operations and on our business and operations as its parent.

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Risks Related to Registration or Regulatory Approval of Our Product Candidates and Other Government Regulations

Our business is subject to continuing regulatory oversight by Jose Moreno againstthe FDA and other authorities, whose requirements are costly to comply with, and our failure to comply could result in negative effects on our business.

The FDA has specific regulations governing human cell, tissue, and cellular and tissue-based products, commonly known as “HCT/Ps”. The FDA has broad post-market and regulatory and enforcement powers. The FDA’s regulation of HCT/Ps includes requirements for registration and listing of products, donor screening and testing, processing and distribution (“Current Good Tissue Practices” or “cGTP”), labeling, record keeping, adverse-reaction reporting, inspection, and enforcement.

When SkinTE was registered and listed with the FDA, we believed SkinTE was appropriately regulated solely under Section 361 of the Public Health Service Act and Part 1271 of Title 21 of the Code of Federal Regulations (i.e., as a so-called “361 HCT/P”) and that, as a result, no premarket review or approval by the FDA was required. We still believe that SkinTE is appropriately regulated as a 361 HCT/P. However, following informal, voluntary discussions between FDA and the Company, and two directorspreliminary views expressed by FDA received on April 21, 2020, we believe that the FDA may disagree with our interpretation if we sought a formal designation of SkinTE’s regulatory classification, and that it therefore is prudent to pursue a strategy to file an investigational new drug application (“IND”) and thereafter a biologics license application (“BLA”) for SkinTE. While we could pursue a formal designation, and we could potentially challenge FDA’s formal designation administratively or in court if we disagreed with their interpretation of the Company, Case No. 2:18-cv-00510-JNP (the “Moreno Complaint”)regulations, that would be a lengthy and costly process that would put us in a highly adversarial position vis-à-vis the FDA. Moreover, courts give deference to administrative agencies’ interpretations of governing regulations, and an adverse formal decision from either FDA or a federal court, or both, could have significant negative consequences on our ability to continue our collaborative relationship with the FDA.

FDA has not asked us to stop marketing SkinTE at this time, but we could be required to withdraw SkinTE from the market until the required clinical trials are complete and the applicable premarket regulatory clearances or approvals are obtained. Manufacturers of new drugs, biologics, and some medical devices must complete extensive clinical trials, which must be conducted pursuant to an effective IND or investigational device exemption (IDE). On July 6, 2018,In addition, the FDA must review and approve a similar complaint was filedBLA or new drug application before a new drug or biologic may be marketed and must approve or clear most medical devices prior to marketing.

The preliminary assessment by the FDA that SkinTE appears to be a biological product that would be regulated under Section 351 of the Public Health Service Act will negatively impact our commercialization of the product and substantially increase the cost to us of regulatory compliance, all of which could adversely affect our results of operations and financial condition. This same risk applies to any other product we may develop that we believe should be regulated as a 361 HCT/P but where the FDA may disagree with our interpretation of the applicable regulations.

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Some of the future new products and enhancements of existing products that we expect to develop and market may not be 361 HCT/Ps, and may require premarket approval or clearance from the FDA. As a result, those product candidates would be subject to additional regulatory requirements, including premarket approval or clearance. There can be no assurance, however, that approval or clearance will be granted with respect to SkinTE, any such products, or enhancements of existing products. Such products or enhancements may encounter significant delays during FDA’s premarket review process that would adversely affect our ability to market such products or enhancements.

Even if premarket approval or clearance are obtained from the FDA, the approvals or clearances may contain substantial limitations on the indicated uses of such products and other uses may be prohibited. Product approvals by the FDA can also be withdrawn due to failure to comply with regulatory standards or the occurrence of unforeseen problems following initial approval. Furthermore, the FDA could limit or prevent the distribution of products, and the FDA has the power to require the recall of such products. FDA regulations depend heavily on administrative interpretation, and there can be no assurance that future interpretations made by the FDA or other regulatory bodies will not adversely affect our operations. In addition, regulatory clearance or approval is subject to continuing compliance with regulatory standards, including the FDA’s current good manufacturing practice (cGMP) or quality system regulations and adverse event reporting regulations, and additional clearance, approval, or regulatory reporting may be needed for changes made to products following their initial clearance or approval.

If we fail to comply with the FDA regulations regarding our products and manufacturing processes, the FDA could initiate or take formal enforcement action or other actions, including, without limitation, any of the following:

Untitled letters, warning letters, fines, injunctions, consent decrees, product seizures, or civil penalties;
Operating restrictions, partial suspension or total shutdown of clinical studies, manufacturing, marketing, or distribution;
Orders to recall or destroy products.
Refusing requests for clearance or approval of new products, processes, or procedures, or for certificates or approval to enable export of the same;
Withdrawing or suspending current applications for approval or clearance, or any approvals or clearances already granted; and
Civil or criminal prosecution.

It is likely that the FDA’s regulation of 361 HCT/Ps and other types of products (e.g., drugs, devices, or biologics) will continue to evolve in the same court againstfuture. Complying with any such new regulatory requirements, guidance or statutes may entail significant time delays and expense, which could have a material adverse effect on our business. While the same defendantsFDA may issue new or revised guidance or regulations for 361 HCT/Ps, drugs, devices, or biologics, we do not know whether or when such revised draft or final guidance or regulations (if any) will be issued, the scope of such guidance, any new rules or regulations, whether they will apply to our technologies or products, or whether they will be advantageous or disadvantageous to us. In addition, even if it does not issue new regulations or guidance, the FDA could in the future adopt more restrictive interpretations of existing regulations or increase its enforcement activity, which may adversely affect our business.

Our failure to comply with the regulatory guidelines set forth by Yedid Lawi, Case No. 2:18-cv-00541-PMW (the “Lawi Complaint”).the FDA with respect to our product candidates could delay or prevent the completion of market entry, clinical trials, the approval or registration of any product candidates, or the commercialization of our product candidates.

We are subject to regulation and inspection by the FDA for cGTP compliance with respect to our 361 HCT/P products, and we will need to transition to cGMP manufacturing for SkinTE as we pursue a BLA. To the extent that products we develop are not regulated as 361 HCT/Ps, in addition to cGTP, we will be subject to regulation under cGMP as well as to FDA premarket approval or clearance requirements. Complying with cGTP and cGMP requires that we expend time, money, and effort in production, recordkeeping, and quality control to assure that the product meets applicable specifications and other requirements. For any products for which we are required to obtain FDA premarket approval, we must also pass a pre-approval inspection prior to FDA approval or clearance. Failure to pass a pre-approval inspection may significantly delay FDA approval of our product candidates. If we fail to comply with these requirements, we would be subject to possible regulatory action and may be limited in the jurisdictions in which we are permitted to sell our product candidates. As a result, our business, financial condition, and results of operations may be materially harmed.

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The manufacture of cell and tissue-based therapy products, such as our product candidates, is highly complex and is characterized by inherent risks and challenges such as autologous raw material inconsistencies, logistical challenges, significant quality control and assurance requirements, manufacturing complexity, and significant manual processing. Unlike products that rely on chemicals for efficacy, such as most pharmaceuticals, cell and tissue-based therapy products are difficult to characterize due to the inherent variability of biological input materials.

Additionally, we have limited experience in manufacturing products for commercial purposes and could experience difficulties in the continued manufacturing of our product candidates, either ourselves or through third-party contractors with whom we may enter strategic relationships. Because our experience in manufacturing, sales, marketing, and distribution is limited, we may encounter unforeseen difficulties in our efforts to efficiently manage the manufacturing, sale, and distribution of our product candidates, or have to rely on third-party contractors, over which we may not have sole control, to manufacture our product candidates. Moreover, there can be no assurance that we or any third-party contractors with whom we enter strategic relationships will be successful in streamlining manufacturing operations and implementing efficient, low-cost manufacturing capabilities and processes that will enable us to meet the quality, price, and production standards or production volumes necessary to achieve profitability. Our failure to develop these manufacturing processes and capabilities in a timely manner could prevent us from achieving positive results of operations and cash flows.

Even if the FDA regulates any of our products as 361 HCT/P, we must still generate adequate substantiation for any claims we will make in our marketing. Failure to establish such adequate substantiation in the opinion of federal or state authorities could substantially impair our ability to generate revenue.

Even if we are permitted to continue marketing SkinTE for some period of time before making a submission to the FDA for premarket approval, we still must generate adequate substantiation for claims we make in our marketing materials. Both the Moreno ComplaintFederal Trade Commission (“FTC”) and Lawi Complaint allegethe states retain jurisdiction over the marketing of 361 HCT/Ps (and other) products in commerce and require a reasonable basis for claims made in marketing materials, and FDA has similar requirements for the labeling and promotion of HCT/Ps that are also considered drugs, biologics, or medical devices. Through clinical use, case studies, clinical studies, as well as other endeavors, we intend to generate such adequate substantiation for any claims we make about our products. If, however, after we commence marketing of any of our products, including SkinTE, the defendants madeFTC, FDA or one or more states conclude that we lack adequate substantiation for our claims, we may be subject to significant penalties, or may be forced to alter our marketing approach in one or more jurisdictions. Any of this could materially harm our business.

Even if any of our products meet the criteria for a 361 HCT/P, they will be subject to ongoing regulation. We could be subject to significant penalties if we fail to comply with these requirements, which would adversely affect our results of operations.

If one or more of our products meets the criteria for a 361 HCT/P or we are able to continue marketing SkinTE before receiving BLA approval, we would still be subject to numerous post-market requirements, including those related to registration and listing, record keeping, labeling, cGTP, donor eligibility, deviation and adverse event reporting, and other activities. HCT/Ps that do not meet the definition of a 361 HCT/P are also subject to these or additional obligations. If we fail to comply with these requirements, we could be subject to, without limitation, warning letters, product seizures, injunctions, or civil and criminal penalties. We have established our own processing facility, which we believe is cGTP compliant. Any failure by us to maintain cGTP compliance would require remedial actions, which could potentially include actions such as delays in distribution and sales of our product, as well as enforcement actions.

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Clinical trials can be long and expensive, and results are ultimately uncertain, which could jeopardize PolarityTE’s ability to obtain regulatory approval for its SkinTE product.

PolarityTE will likely be required to perform one or more clinical trials for SkinTE under FDA’s statutory requirements to obtain approval of a BLA for the product. Clinical trials can be expensive, can take several years to execute, and are subject to factors within and outside of PolarityTE’s control. The outcomes of clinical trials are uncertain. PolarityTE has not yet submitted an IND to FDA to conduct clinical trials to support a BLA for SkinTE. PolarityTE has two ongoing randomized controlled clinical trials—one in diabetic foot ulcers (DFUs) and one in venous leg ulcers (VLUs)—that were responsiblebeing conducted with SkinTE as a 361 HCT/P. While those trials are being conducted pursuant to protocols approved by an institutional review board (IRB), we do not know whether data from those trials or other clinical investigations previously conducted with SkinTE will be able to be used as part of a clinical data package for disseminating informationa SkinTE BLA submission.

PolarityTE will likely need to the public through reports filedensure compliance with applicable regulations for a BLA submission by transitioning its quality system to 21 CFR Parts 210/211 and 600-610 regulations with the SecuritiesFDA. Final determination of regulatory compliance with 21 CFR Parts 210/211 and Exchange Commission and other channels that contained material misstatements or omissions in violation of Sections 10 and 20(a)600-610 would be made during FDA’s pre-license inspection as part of the Exchange Act and Rule 10b-5 adopted thereunder. Specifically, both complaints allege thatBLA review. If 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 inLawi 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 60 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 a 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 consolidated complaint are without merit, and intends to defend the litigation, vigorously. The Company filed a motion to dismiss the consolidated complaint on June 3, 2019. Plaintiffs’ opposition to the Company’s motion to dismiss was filed on August 2, 2019, and the Company expects to file a reply to the opposition on or about September 13, 2019. At this early stage of the proceedings the CompanyFDA is unable to makeagree with PolarityTE, or PolarityTE is unable to meet the standards required of it by the FDA, regarding preclinical studies, clinical studies and chemistry, manufacturing and controls, the approval of any prediction regardingBLA would not occur or would be delayed.

The results of non-clinical studies do not necessarily predict future clinical trial results and predecessor clinical trial results may not be repeated in subsequent clinical trials. Additionally, the outcomeFDA may disagree with PolarityTE’s interpretation of the litigation.

Indata from its non-clinical studies and clinical trials, and may require the ordinary coursecompany to pursue additional non-clinical studies or clinical trials, or not approve any BLA that PolarityTE may submit. If PolarityTE is unable to demonstrate the safety and efficacy of business, we may become involved in lawsuits, claims, investigations, proceedings, and threats of litigation relatingits product through its clinical trials, it will be unable to intellectual property, commercial arrangements,obtain regulatory compliance, and other matters. Exceptapproval to market SkinTE as noted above, at June 30, 2019, we were not party to any legal or arbitration proceedings that may have significant effects on our financial position 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.

Item 2. Unregistered Sales of Equity Securities and Use of Proceedslicensed biologic.

 

Unregistered SalePolarityTE will rely on third parties to conduct its clinical trial and they may not perform as contractually required or expected.

PolarityTE may rely on third parties, such as contract research organizations (“CROs”), medical institutions, clinical investigators and contract laboratories to conduct its clinical trials and potentially certain nonclinical studies to support a BLA for SkinTE. PolarityTE and its CROs are also required to comply with all applicable regulations governing nonclinical and clinical research, including good laboratory practice (“GLP”) and good clinical practice (“GCP”). The FDA enforces these regulations through periodic inspections of Securitiestrial sponsors, principal investigators, CROs and trial sites. If PolarityTE or its CROs fail to comply with applicable FDA regulations, the data generated in clinical trials may be deemed unreliable and the FDA may require PolarityTE to perform additional clinical trials before approving its applications. PolarityTE cannot be certain that, upon inspection, the FDA and similar foreign regulatory authorities will determine that PolarityTE’s clinical trials comply or complied with clinical trial regulations, including GCP. In addition, PolarityTE’s clinical trials in support of a BLA may need to be conducted with product produced under applicable cGMP regulations. Failure to comply with the clinical trial regulations may require PolarityTE to repeat clinical trials, which would delay the regulatory approval process. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if these third parties need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to PolarityTE’s clinical protocols or regulatory requirements or for other reasons, PolarityTE’s non-clinical development activities or clinical trials may be extended, delayed, suspended or terminated, and it would not be able to obtain regulatory approval for its products on a timely basis, if at all, and its business, results of operations, financial condition and growth prospects would be adversely affected. Furthermore, PolarityTE’s third party clinical trial investigators may be delayed in conducting its clinical trials for reasons outside of their control.

 

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As of June 30, 2019, the Company accepted the exercise in March 2019 of a stock option in reliance on the exemption from registration set forth in Section 4(a)(2) of the Securities Act of 1933, as amended, pursuant to which the option holder elected Company withholding of the shares required to exercise the option and cover the tax liability associated with the exercise. The option exercise was for the purchase of 9,167 shares at a purchase price of $14.25 per share, and based on a market value of $16.43 on the date of exercise the Company issued a net total of 795 shares of common stock to the option holder, which includes shares withheld for taxes.

 

Item 6. Exhibits

 

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

 

4.1Form of Common Stock Warrant Certificate (incorporated by reference to Exhibit 4.1 to our Current Report on Form 8-K filed on February 14, 2020)
4.2Form of Warrant Agency Agreement (incorporated by reference to Exhibit 4.2 to our Current Report on Form 8-K filed on February 14, 2020)
10.1Amendment No. 1Form of Indemnification Agreement (incorporated by reference to Employment Agreement with Richard Hague dated June 28, 2019Exhibit 4.2 to our Current Report on Form 8-K filed on March 25, 2020)
10.2Amendment No.Separation, Transition and Release of Claims Agreement dated March 31, 2020 (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on April 1, to Employment Agreement with David Seaburg dated June 28, 20192020)
10.3Amendment No. 1Note and Loan Agreement dated April 12, 2020, between PolarityTE MD, Inc., and KeyBank National Association (incorporated by reference to Employment Agreement with Paul Mann dated June 28, 2019
10.4Exhibit 10.1 to our Current Report on Form of Notice and Agreement for Restricted Stock Grant (1)8-K filed on April 15, 2020)
31.1Certification Pursuant to Rule 13a-14(a)
31.2Certification Pursuant to Rule 13a-14(a).
31.3Certification Pursuant to Rule 13a-14(a)
32.1Certification Pursuant to Rule 13a-14(b) and Section 1350, Chapter 63 of Title 18, United States Code
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) Form for granting restricted stock awards, including restricted stock awards granted on July 1, 2019 to: (a) Richard Hague, Chief Operating Officer, for 129,825 common shares that are restricted from transfer by reference to continued employment by the Company, and the restriction on transfer lapses with respect to 10,819 shares in August 2019 and the remainder in monthly installments through June 2021; (b) Paul Mann, Chief Financial Officer, for 140,351 common shares that are restricted from transfer by reference to continued employment by the Company, and the restriction on transfer lapses with respect to 29,240 shares in December 2019 and the remainder in monthly installments through June 2021; and (c) David Seaburg for 114,035 common shares that are restricted from transfer by reference to continued employment by the Company, and the restriction on transfer lapses with respect to 23,814 shares in December 2019 and the remainder in monthly installments through June 2021.

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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/ Paul Mann
Paul Mann

Chief Financial Officer

Duly Authorized Officer 
   
Date:August 8, 2019 May 11, 2020 /s/ David Seaburg
David Seaburg
Chief Executive Officer
Duly Authorized Officer
Date: May 11, 2020/s/ Jacob Patterson
Jacob Patterson
Interim Chief Financial Officer
Chief Accounting Officer

 

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