Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2020 | Aug. 03, 2020 | |
Schedule of Capitalization, Equity [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2020 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2020 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-32404 | |
Entity Registrant Name | POLARITYTE, INC. | |
Entity Central Index Key | 0001076682 | |
Entity Tax Identification Number | 06-1529524 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 1960 S. 4250 West | |
Entity Address, City or Town | Salt Lake City | |
Entity Address, State or Province | UT | |
Entity Address, Postal Zip Code | 84104 | |
City Area Code | (800) | |
Local Phone Number | 560-3983 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 38,740,704 | |
Common Stock, Par Value $0.001 [Member] | ||
Schedule of Capitalization, Equity [Line Items] | ||
Title of 12(b) Security | Common Stock, Par Value $0.001 | |
Trading Symbol | PTE | |
Security Exchange Name | NASDAQ | |
Preferred Stock Purchase Rights [Member] | ||
Schedule of Capitalization, Equity [Line Items] | ||
Title of 12(b) Security | Preferred Stock Purchase Rights | |
No Trading Symbol Flag | false | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets | ||
Cash and cash equivalents | $ 30,504 | $ 10,218 |
Short-term investments | 19,022 | |
Accounts receivable, net | 2,115 | 1,731 |
Inventory | 281 | 252 |
Prepaid expenses and other current assets | 2,453 | 1,264 |
Total current assets | 35,353 | 32,487 |
Property and equipment, net | 12,729 | 14,911 |
Operating lease right-of-use assets | 3,559 | 4,590 |
Intangible assets, net | 636 | 731 |
Goodwill | 278 | 278 |
Other assets | 599 | 602 |
TOTAL ASSETS | 53,154 | 53,599 |
Current liabilities | ||
Accounts payable and accrued expenses | 5,050 | 7,095 |
Other current liabilities | 2,644 | 2,338 |
Current portion of long-term notes payable | 1,436 | 528 |
Deferred revenue | 97 | 98 |
Total current liabilities | 9,227 | 10,059 |
Common stock warrant liability | 8,736 | |
Operating lease liabilities | 2,192 | 2,994 |
Other long-term liabilities | 1,022 | 1,630 |
Long-term notes payable | 2,410 | |
Total liabilities | 23,587 | 14,683 |
Commitments and Contingencies (Note 14) | ||
STOCKHOLDERS’ EQUITY | ||
Preferred stock - 25,000,000 shares authorized, 0 shares issued and outstanding at June 30, 2020 and December 31, 2019 | ||
Common stock – $.001 par value; 250,000,000 shares authorized; 38,496,910 and 27,374,653 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively | 38 | 27 |
Additional paid-in capital | 490,603 | 474,174 |
Accumulated other comprehensive income | 72 | |
Accumulated deficit | (461,074) | (435,357) |
Total stockholders’ equity | 29,567 | 38,916 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 53,154 | $ 53,599 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Preferred stock, shares authorized | 25,000,000 | 25,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 250,000,000 | 250,000,000 |
Common stock, shares issued | 38,496,910 | 27,374,653 |
Common stock, shares outstanding | 38,496,910 | 27,374,653 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Net revenues | ||||
Total net revenues | $ 2,266 | $ 1,326 | $ 3,199 | $ 2,791 |
Cost of sales | ||||
Total cost of sales | 882 | 596 | 1,398 | 1,372 |
Gross profit | 1,384 | 730 | 1,801 | 1,419 |
Operating costs and expenses | ||||
Research and development | 3,164 | 4,764 | 6,537 | 10,116 |
General and administrative | 5,211 | 15,060 | 15,816 | 32,255 |
Sales and marketing | 2,024 | 3,981 | 5,718 | 7,934 |
Restructuring and other charges | 2,084 | 2,536 | ||
Total operating costs and expenses | 12,483 | 23,805 | 30,607 | 50,305 |
Operating loss | (11,099) | (23,075) | (28,806) | (48,886) |
Other income (expenses) | ||||
Change in fair value of common stock warrant liability | (1,591) | 2,941 | ||
Interest (expense) income, net | (65) | 29 | (77) | 99 |
Other income, net | 78 | 254 | 225 | 422 |
Net loss | $ (12,677) | $ (22,792) | $ (25,717) | $ (48,365) |
Net loss per share, basic and diluted | $ (0.33) | $ (0.92) | $ (0.72) | $ (2.09) |
Weighted average shares outstanding, basic and diluted | 38,428,289 | 24,768,453 | 35,724,141 | 23,190,343 |
Products [Member] | ||||
Net revenues | ||||
Total net revenues | $ 944 | $ 504 | $ 1,372 | $ 801 |
Cost of sales | ||||
Total cost of sales | 275 | 342 | 615 | 615 |
Services [Member] | ||||
Net revenues | ||||
Total net revenues | 1,322 | 822 | 1,827 | 1,990 |
Cost of sales | ||||
Total cost of sales | $ 607 | $ 254 | $ 783 | $ 757 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) (USD $) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Income Statement [Abstract] | ||||
Net loss | $ (12,677) | $ (22,792) | $ (25,717) | $ (48,365) |
Other comprehensive income/(loss): | ||||
Unrealized gain on available-for-sale securities | 7 | 160 | 11 | 312 |
Reclassification of realized gains included in net loss | (10) | (134) | (83) | (269) |
Comprehensive loss | $ (12,680) | $ (22,766) | $ (25,789) | $ (48,322) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Balance – March 31, 2019 at Dec. 31, 2018 | $ 21 | $ 414,840 | $ 36 | $ (342,864) | $ 72,033 |
Balance, shares at Dec. 31, 2018 | 21,447,088 | ||||
Stock-based compensation expense | 10,327 | 10,327 | |||
Stock-based compensation expense, shares | |||||
Stock option exercises | $ 1 | 528 | 529 | ||
Stock option exercises, shares | 283,250 | ||||
Vesting of restricted stock units | |||||
Vesting of restricted stock units, shares | 100,912 | ||||
Shares withheld for tax withholding | (740) | (740) | |||
Shares withheld for tax withholding, shares | (82,011) | ||||
Other comprehensive income | 17 | 17 | |||
Forfeiture of restricted stock awards, shares | |||||
Net loss | (25,573) | (25,573) | |||
Balance – June 30, 2019 at Mar. 31, 2019 | $ 22 | 424,955 | 53 | (368,437) | 56,593 |
Balance, shares at Mar. 31, 2019 | 21,749,239 | ||||
Balance – March 31, 2019 at Dec. 31, 2018 | $ 21 | 414,840 | 36 | (342,864) | 72,033 |
Balance, shares at Dec. 31, 2018 | 21,447,088 | ||||
Net loss | (48,365) | ||||
Balance – June 30, 2019 at Jun. 30, 2019 | $ 25 | 461,491 | 79 | (391,229) | 70,366 |
Balance, shares at Jun. 30, 2019 | 25,218,606 | ||||
Balance – March 31, 2019 at Mar. 31, 2019 | $ 22 | 424,955 | 53 | (368,437) | 56,593 |
Balance, shares at Mar. 31, 2019 | 21,749,239 | ||||
Stock-based compensation expense | 8,618 | 8,618 | |||
Stock-based compensation expense, shares | |||||
Stock option exercises | |||||
Stock option exercises, shares | 9,167 | ||||
Vesting of restricted stock units | |||||
Vesting of restricted stock units, shares | 51,440 | ||||
Shares withheld for tax withholding | (62) | (62) | |||
Shares withheld for tax withholding, shares | (17,418) | ||||
Other comprehensive income | 26 | 26 | |||
Proceeds received from issuance of common stock, net of issuance costs of $1,146 | 3 | 27,945 | $ 27,948 | ||
Proceeds received from issuance of common stock, net of issuance costs of $1,146, shares | 3,418,918 | ||||
Shares issued under the ESPP | 35 | $ 35 | |||
Shares issued under the ESPP, shares | 7,260 | ||||
Net loss | (22,792) | (22,792) | |||
Balance – June 30, 2019 at Jun. 30, 2019 | $ 25 | 461,491 | 79 | (391,229) | 70,366 |
Balance, shares at Jun. 30, 2019 | 25,218,606 | ||||
Balance – March 31, 2019 at Dec. 31, 2019 | $ 27 | 474,174 | 72 | (435,357) | 38,916 |
Balance, shares at Dec. 31, 2019 | 27,374,653 | ||||
Issuance of common stock, net of issuance costs of $1.3 million | $ 11 | 12,588 | 12,599 | ||
Issuance of common stock, net of issuance costs of $1.3 million, shares | 10,854,710 | ||||
Stock-based compensation expense | 3,221 | 3,221 | |||
Stock-based compensation expense, shares | |||||
Stock option exercises | 31 | 31 | |||
Stock option exercises, shares | 10,000 | ||||
Vesting of restricted stock units | |||||
Vesting of restricted stock units, shares | 158,513 | ||||
Shares withheld for tax withholding | (5) | (5) | |||
Shares withheld for tax withholding, shares | (4,587) | ||||
Other comprehensive income | (69) | $ (69) | |||
Proceeds received from issuance of common stock, net of issuance costs of $1,146, shares | 0 | ||||
Purchase of ESPP shares, shares | |||||
Shares issued under the ESPP, shares | |||||
Net loss | (13,040) | $ (13,040) | |||
Balance – June 30, 2019 at Mar. 31, 2020 | $ 38 | 490,009 | 3 | (448,397) | 41,653 |
Balance, shares at Mar. 31, 2020 | 38,393,289 | ||||
Balance – March 31, 2019 at Dec. 31, 2019 | $ 27 | 474,174 | 72 | (435,357) | 38,916 |
Balance, shares at Dec. 31, 2019 | 27,374,653 | ||||
Net loss | (25,717) | ||||
Balance – June 30, 2019 at Jun. 30, 2020 | $ 38 | 490,603 | (461,074) | 29,567 | |
Balance, shares at Jun. 30, 2020 | 38,496,910 | ||||
Balance – March 31, 2019 at Mar. 31, 2020 | $ 38 | 490,009 | 3 | (448,397) | 41,653 |
Balance, shares at Mar. 31, 2020 | 38,393,289 | ||||
Stock-based compensation expense | 563 | 563 | |||
Stock-based compensation expense, shares | |||||
Vesting of restricted stock units | |||||
Vesting of restricted stock units, shares | 119,132 | ||||
Shares withheld for tax withholding | (9) | (9) | |||
Shares withheld for tax withholding, shares | (6,918) | ||||
Other comprehensive income | (3) | (3) | |||
Purchase of ESPP shares | 40 | 40 | |||
Purchase of ESPP shares, shares | 38,293 | ||||
Forfeiture of restricted stock awards | |||||
Forfeiture of restricted stock awards, shares | (46,886) | ||||
Net loss | (12,677) | (12,677) | |||
Balance – June 30, 2019 at Jun. 30, 2020 | $ 38 | $ 490,603 | $ (461,074) | $ 29,567 | |
Balance, shares at Jun. 30, 2020 | 38,496,910 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2020 | Jun. 30, 2019 |
Statement of Stockholders' Equity [Abstract] | ||
Proceeds received from issuance of common stock, net of issuance costs | $ 1,300 | $ 1,146 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (25,717) | $ (48,365) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock based compensation expense | 3,784 | 18,907 |
Depreciation and amortization | 1,549 | 1,446 |
Amortization of intangible assets | 95 | 99 |
Amortization of debt discount | 13 | 28 |
Change in fair value of common stock warrant liability | (2,941) | |
Change in fair value of contingent consideration | (48) | |
Loss on abandonment of property and equipment | 1,529 | |
Other non-cash adjustments | (21) | 30 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (384) | (624) |
Inventory | (29) | (26) |
Prepaid expenses and other current assets | (1,189) | (486) |
Operating lease right-of-use assets | 899 | 791 |
Other assets | 3 | 25 |
Accounts payable and accrued expenses | (2,109) | (17) |
Other current liabilities | 9 | 367 |
Deferred revenue | (1) | (126) |
Operating lease liabilities | (903) | (670) |
Other long-term liabilities | (120) | |
Net cash used in operating activities | (25,413) | (28,789) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchase of property and equipment | (1,170) | (2,110) |
Purchase of available-for-sale securities | (14,144) | (15,445) |
Proceeds from maturities of available-for-sale securities | 16,945 | 9,278 |
Proceeds from sale of available-for-sale securities | 16,171 | |
Net cash provided by (used in) investing activities | 17,802 | (8,277) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Net proceeds from the sale of common stock and warrants | 24,276 | 27,948 |
Proceeds from stock options exercised | 31 | 529 |
Proceeds from ESPP purchase | 40 | 35 |
Cash paid for tax withholdings related to net share settlement | (6) | (636) |
Payment of contingent consideration liability | (109) | |
Principal payments on financing leases | (243) | (225) |
Proceeds from term note payable and financing arrangements | 4,629 | |
Principal payments on term note payable and financing arrangements | (830) | (262) |
Net cash provided by financing activities | 27,897 | 27,280 |
Net increase (decrease) in cash and cash equivalents | 20,286 | (9,786) |
Cash and cash equivalents - beginning of period | 10,218 | 55,673 |
Cash and cash equivalents - end of period | 30,504 | 45,887 |
Non-cash investing and financing activities: | ||
Unpaid liability for acquisition of property and equipment | 63 | |
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 | 7 | 43 |
Allocation of proceeds from sale of common stock and warrants to warrant liability | $ 11,677 |
PRINCIPAL BUSINESS ACTIVITY AND
PRINCIPAL BUSINESS ACTIVITY AND BASIS OF PRESENTATION | 6 Months Ended |
Jun. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
PRINCIPAL BUSINESS ACTIVITY AND BASIS OF PRESENTATION | 1. PRINCIPAL BUSINESS ACTIVITY AND BASIS OF PRESENTATION PolarityTE, Inc. (together with its subsidiaries, the “Company”) is a biotechnology company developing and commercializing regenerative tissue products and 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, 2019 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 year ended December 31, 2019 filed with the Securities and Exchange Commission on Form 10-K on March 12, 2020. |
LIQUIDITY AND NEED FOR ADDITION
LIQUIDITY AND NEED FOR ADDITIONAL CAPITAL | 6 Months Ended |
Jun. 30, 2020 | |
Liquidity And Need For Additional Capital | |
LIQUIDITY AND NEED FOR ADDITIONAL CAPITAL | 2. LIQUIDITY AND NEED FOR ADDITIONAL CAPITAL The Company has experienced recurring losses and cash outflows from operating activities. As of June 30, 2020, the Company had an accumulated deficit of $ 461.1 30.5 On April 10, 2019, the Company completed an underwritten offering providing for the issuance and sale of 3,418,918 0.001 8.51 27.9 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 2.00 36 54,090 2.31 0.1 216,412 0.6 On February 14, 2020, the Company completed an underwritten offering of 10,638,298 10,638,298 2.35 2.80 February 12, 2027 22.5 The Company entered into a promissory note for $ 3.6 The Company does not expect existing cash as of June 30, 2020 to be sufficient to fund the Company’s operations for at least twelve months from the date of filing. These financial statements have been prepared on a going concern basis, which assumes the Company will continue to realize its assets and settle its liabilities in the normal course of business. The Company has incurred recurring losses and negative cash flows, has not yet generated material revenue from operations, and will require additional funds to maintain its operations. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern within one year after these condensed consolidated financial statements are issued. In the second quarter of 2020 the Company took steps to reduce cash burn by reducing payroll expense, adopting a salary and wage reduction, and reducing discretionary spending across the organization to minimal levels. The Company will seek additional capital through equity offerings or debt financing. However, such financing may not be available in the future on favorable 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, or be unable to continue operations over a longer term. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation Use of estimates Cash and cash equivalents Leases The Company has lease agreements with lease and non-lease components. As allowed under ASC 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 ASC 842 to leases with a term of 12 months or less for all classes of assets. Revenue Recognition The Company records product revenues primarily from the sale of its regenerative tissue products. The Company sells its products to healthcare providers (customers), 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. The Company records service revenues from the sale of its preclinical research services and contract services. Preclinical research services include delivery of preclinical studies and other research services to unrelated third parties. These customer contracts 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 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 due upfront and the remainder upon completion of the contract, with most contracts completing in less than a year. Contract services include research and laboratory testing services to unrelated third parties on a contract basis. These customer contracts generally consist of a single performance obligation that the Company satisfies at a point in time. The Company recognizes revenue upon delivery of testing results to the customer. Research and Development Expenses Accruals for Research and Development Expenses and Clinical Trials Common Stock Warrant Liability Stock-Based Compensation The fair value of 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 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 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. Impairment of Long-Lived Assets Recent Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses (Topic 326) Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and Leases (Topic 842): Effective Dates Recently Adopted 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 |
FAIR VALUE
FAIR VALUE | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE | 4. FAIR VALUE In accordance with ASC 820, Fair Value Measurements and Disclosures ● Level 1: Observable inputs such as quoted prices in active markets for identical instruments. ● Level 2: Quoted prices for similar instruments that are directly or indirectly observable in the market. ● Level 3: Significant unobservable inputs supported by little or no market activity. Financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, for which determination of fair value requires significant judgment or estimation. 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. During the three months ended June 30, 2020, the Company transferred all available-for-sale securities to cash accounts. 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 (in thousands): SCHEDULE OF FAIR VALUE OF FINANCIAL INSTRUMENTS MEASURED ON RECURRING BASIS June 30, 2020 Level 1 Level 2 Level 3 Total Liabilities: Common stock warrant liability $ – $ – $ 8,736 $ 8,736 Total $ – $ – $ 8,736 $ 8,736 December 31, 2019 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 2,019 $ – $ – $ 2,019 Commercial paper – 11,064 – 11,064 Corporate debt securities – 8,982 – 8,982 U.S. government debt securities – 3,770 – 3,770 Total $ 2,019 $ 23,816 $ – $ 25,835 Liabilities: Contingent consideration $ – $ – $ 31 $ 31 Total $ – $ – $ 31 $ 31 The fair value of the 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 expected term. The fair value of the warrant liability was $ 11.7 8.7 The following assumptions were used in estimating the fair value of the warrant liability as of June 30, 2020 and upon the issuance date of February 14, 2020: SCHEDULE OF FAIR VALUE ASSUMPTIONS OF WARRANTS LIABILITY June 30, 2020 February 14, 2020 Stock price $ 1.24 $ 1.69 Exercise price $ 2.80 $ 2.80 Risk-free rate 0.45% 1.51% Volatility 97.5% 93.40% Term 6.62 6.99 The contingent consideration related to the IBEX acquisition of $ 31 |
CASH EQUIVALENTS AND SHORT-TERM
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS | 6 Months Ended |
Jun. 30, 2020 | |
Cash and Cash Equivalents [Abstract] | |
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS | 5. CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS During the three months ended June 30, 2020, the Company transferred all available-for-sale securities to cash accounts. Cash equivalents and short-term investments consisted of the following as of December 31, 2019 (in thousands): SCHEDULE OF CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS December 31, 2019 Amortized Cost Unrealized Gains Unrealized Losses Market Value Cash equivalents: Money market funds $ 2,019 $ – $ – $ 2,019 Commercial paper 1,020 4 – 1,024 U.S. government debt securities 3,761 9 – 3,770 Total cash equivalents (1) 6,800 13 – 6,813 Short-term investments: Commercial paper 9,986 54 – 10,040 Corporate debt securities 8,977 5 – 8,982 Total short-term investments 18,963 59 – 19,022 Total $ 25,763 $ 72 $ – $ 25,835 (1) Included in cash and cash equivalents in the Company’s consolidated balance sheet as of December 31, 2019 in addition to $ 3.4 For the six months ended June 30, 2020 and 2019, the Company recognized net realized gains on available-for-sale securities of $ 0.1 0.3 |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 6 Months Ended |
Jun. 30, 2020 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT, NET | 6. PROPERTY AND EQUIPMENT, NET The following table presents the components of property and equipment, net (in thousands): SCHEDULE OF PROPERTY AND EQUIPMENT, NET June 30, 2020 December 31, 2019 Machinery and equipment $ 12,198 $ 12,083 Land and buildings 2,000 2,000 Computers and software 1,255 1,189 Leasehold improvements 3,044 2,282 Construction in progress 179 1,606 Furniture and equipment 233 470 Total property and equipment, gross 18,909 19,630 Accumulated depreciation and amortization (6,180 ) (4,719 ) Total property and equipment, net $ 12,729 $ 14,911 The Company abandoned $ 1.5 Depreciation and amortization expense for property and equipment, including assets acquired under financing leases was as follows (in thousands): SCHEDULE OF DEPRECIATION AND AMORTIZATION EXPENSE For the Three Months Ended For the Six Months Ended June 30, June 30, 2020 2019 2020 2019 General and administrative expense $ 408 $ 407 $ 800 $ 764 Research and development expense 389 363 749 682 Total depreciation and amortization expense $ 797 $ 770 $ 1,549 $ 1,446 |
LEASES
LEASES | 6 Months Ended |
Jun. 30, 2020 | |
Leases | |
LEASES | 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. As of June 30, 2020, the maturities of our operating and finance lease liabilities were as follows (in thousands): SCHEDULE OF OPERATING AND FINANCE LEASE LIABILITIES Operating leases Finance leases 2020 (excluding the six months ended June 30, 2020) $ 948 $ 335 2021 1,646 656 2022 1,345 405 2023 132 336 2024 87 42 Total lease payments 4,158 1,774 Less imputed interest (452 ) (242 ) Total lease liabilities $ 3,706 $ 1,532 Supplemental balance sheet information related to leases was as follows (in thousands): Finance leases SCHEDULE OF SUPPLEMENTAL BALANCE SHEET INFORMATION RELATED TO FINANCE AND OPERATING LEASES June 30, 2020 December 31, 2019 Finance lease right-of-use assets included within property and equipment, net $ 1,631 $ 2,177 Current finance lease liabilities included within other current liabilities $ 532 $ 508 Non-current finance lease liabilities included within other long-term liabilities 1,000 1,267 Total finance lease liabilities $ 1,532 $ 1,775 Operating leases June 30, 2020 December 31, 2019 Current operating lease liabilities included within other current liabilities $ 1,514 $ 1,746 Operating lease liabilities – non current 2,192 2,994 Total operating lease liabilities $ 3,706 $ 4,740 The components of lease expense were as follows (in thousands): SUMMARY OF COMPONENTS OF LEASE EXPENSE For the Three Months Ended For the Six Months Ended June 30, June 30, 2020 2019 2020 2019 Operating lease costs included within operating costs and expenses $ 548 $ 546 $ 1,104 $ 1,061 Finance lease costs: Amortization of right-of-use assets $ 174 $ 170 $ 349 $ 309 Interest on lease liabilities 39 44 82 67 Total $ 213 $ 214 $ 431 $ 376 Supplemental cash flow information related to leases was as follows (in thousands): SCHEDULE OF SUPPLEMENTAL CASH FLOW INFORMATION RELATED TO LEASES For the Six Months Ended June 30, 2020 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash out flows from operating leases $ 1,108 $ 941 Operating cash out flows from finance leases $ 82 $ 67 Financing cash out flows from finance leases $ 243 $ 225 Lease liabilities arising from obtaining right-of-use assets: Finance leases $ – $ 1,824 Lease payments made in prior period reclassified to property and equipment $ – $ 535 Remeasurement of finance lease liability due to lease modification $ – $ (22 ) Operating leases $ – $ 939 Remeasurement of operating lease liability due to lease modification $ 131 $ – As of June 30, 2020 and December 31, 2019, the weighted average remaining lease term for operating leases was 2.5 and 2.8 years, respectively, and the weighted average discount rate used for operating leases was 9.76% and 9.83% , respectively. As of June 30, 2020 and December 31, 2019, the weighted average remaining lease term for finance leases was 3.0 and 3.5 years, respectively, and the weighted average discount rate used for finance leases was 9.77% for both periods. In May 2020, the Company reduced office space related to one of its existing lease agreements resulting in lower monthly payments. |
ACCOUNTS PAYABLE AND ACCRUED EX
ACCOUNTS PAYABLE AND ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | 6 Months Ended |
Jun. 30, 2020 | |
Payables and Accruals [Abstract] | |
ACCOUNTS PAYABLE AND ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | 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): SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES June 30, 2020 December 31, 2019 Accounts payable $ 423 $ 1,689 Salaries and other compensation 1,815 1,462 Legal and accounting 426 1,404 Accrued severance 1,217 1,053 Benefit plan accrual 560 557 Other 609 930 Total accounts payable and accrued expenses $ 5,050 $ 7,095 Other current liabilities are comprised of the current portion of operating lease liabilities and finance lease liabilities, and short-term debt. The short-term debt had a balance of $0.6 million as of June 30, 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 six months ended June 30, 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 monthly installments, with an interest rate of 4.25% and 6.35% , respectively. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 6 Months Ended |
Jun. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | 9. STOCK-BASED COMPENSATION 2020, 2019 and 2017 Equity Incentive Plans 2020 Plan On October 25, 2019, the Company’s Board of Directors (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 Board will administer the 2020 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 December 19, 2029 18,000 2019 Plan On October 5, 2018, the Company’s 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 October 5, 2028 257,570 2017 Plan On December 1, 2016, the Company’s 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 December 1, 2026 1,177,365 A summary of the Company’s employee and non-employee stock option activity for the six months ended June 30, 2020 is presented below: SCHEDULE OF SHARE-BASED COMPENSATION, STOCK OPTIONS, ACTIVITY Number of Shares Weighted- Average Exercise Price Outstanding – December 31, 2019 4,529,988 $ 15.26 Granted 1,458,026 $ 1.19 Exercised (10,000 ) $ 3.12 Forfeited (867,432 ) $ 11.78 Outstanding – June 30, 2020 5,110,582 $ 11.84 Options exercisable, June 30, 2020 3,603,571 $ 14.87 Employee Stock Purchase Plan (ESPP) In May 2018, the Company adopted the Employee Stock Purchase Plan (“ESPP”). The Company has initially reserved 500,000 85% Restricted Stock A summary of the Company’s employee and non-employee restricted-stock activity is presented below: SCHEDULE OF SHARE-BASED COMPENSATION, RESTRICTED STOCK ACTIVITY Number of Shares Unvested - December 31, 2019 1,843,001 Granted 3,401,036 Vested (1) (832,910 ) Forfeited (79,803 ) Unvested – June 30, 2020 4,331,324 (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. Stock-Based Compensation Expense The stock-based compensation expense related to stock options, restricted stock awards, and the employee stock purchase plan was as follows (in thousands): SCHEDULE OF SHARE-BASED COMPENSATION RELATED TO RESTRICTED STOCK AWARDS AND STOCK OPTIONS For the Three Months Ended For the Six Months Ended June 30, June 30, 2020 2019 2020 2019 General and administrative expense $ 143 $ 6,892 $ 3,220 $ 15,929 Research and development expense 404 1,481 367 2,565 Sales and marketing expense 16 245 197 413 Total stock-based compensation expense $ 563 $ 8,618 $ 3,784 $ 18,907 |
COMMON STOCK WARRANTS
COMMON STOCK WARRANTS | 6 Months Ended |
Jun. 30, 2020 | |
Equity [Abstract] | |
COMMON STOCK WARRANTS | 10. COMMON STOCK WARRANTS On February 14, 2020, the Company completed an underwritten offering of 10,638,298 10,638,298 $2.35 $2.80 February 12, 2027 The change in fair value of the common stock warrant liability is presented in the following table and is reported as a change in fair value of common stock warrant liability in the statements of operations (in thousands): SCHEDULE OF FAIR VALUE OF COMMON STOCK WARRANT LIABILITY June 30, 2020 Beginning balance $ – Initial value of common stock warrant liability 11,677 Change in fair value of common stock warrant liability (2,941 ) Ending balance $ 8,736 |
LOSS PER SHARE
LOSS PER SHARE | 6 Months Ended |
Jun. 30, 2020 | |
Earnings Per Share [Abstract] | |
LOSS PER SHARE | 11. LOSS PER SHARE The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per share for the periods presented due to their anti-dilutive effect: SCHEDULE OF ANTI-DILUTIVE POTENTIAL SHARES OUTSTANDING ACTIVITY As of June 30, 2020 2019 Stock options 5,110,582 6,604,461 Restricted stock 4,331,324 493,447 Common stock warrants 10,638,298 – |
DEBT
DEBT | 6 Months Ended |
Jun. 30, 2020 | |
Debt Disclosure [Abstract] | |
DEBT | 12. DEBT 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 it 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 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 Company will obtain forgiveness of the Loan in whole or in part. |
RESTRUCTURING
RESTRUCTURING | 6 Months Ended |
Jun. 30, 2020 | |
Restructuring and Related Activities [Abstract] | |
RESTRUCTURING | 13. RESTRUCTURING In the first half of 2020, management approved several actions as part of a restructuring plan designed to improve operational efficiency and financial results. Management approved a reduction in force which affected 40 of the 126 employees in the regenerative medicine business segment, or approximately 31.7% of that workforce. The Company did not make any change in the workforce of its contract services segment. The Company recognized $ 0.6 $1.0 million of expense related to employee severance and benefit arrangements for the three and six-month periods ended June 30, 2020, respectively. It is expected that the full amount will be paid by the end of 2020. Management also recorded $1.5 million of asset abandonments within the Company’s regenerative medicine business segment for both the three and six-month periods ended June 30, 2020. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 14. COMMITMENTS AND CONTINGENCIES Contingencies On June 26, 2018, a class action complaint alleging violations of the Federal securities laws was filed in the United States District Court, District of Utah, by Jose Moreno against the Company and two directors of the Company, Case No. 2:18-cv-00510-JNP (the “Moreno Complaint”). On July 6, 2018, a similar complaint was filed in the same court against the same defendants by Yedid Lawi, Case No. 2:18-cv-00541-PMW (the “Lawi Complaint”). Both the Moreno Complaint and Lawi Complaint allege that the defendants made or were responsible for, disseminating information to the public through reports filed with the Securities and Exchange Commission and other channels that contained material misstatements or omissions in violation of Sections 10 and 20(a) of the 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 the Moreno Lawi In re PolarityTE, Inc. Securities Litigation Lawi In November 2018, a shareholder derivative lawsuit was filed in the United States District Court, District of Utah, with the caption Monther v. Lough, et al Other Matters In the ordinary course of business, the 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, as of June 30, 2020, the Company was not party to any legal or arbitration proceedings that may have material effects on its financial position or results of operations. No 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 the Company is either a party adverse to the Company or its subsidiaries or has a material interest adverse to the Company or its subsidiaries. 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. |
CERTAIN RELATIONSHIPS AND RELAT
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS | 6 Months Ended |
Jun. 30, 2020 | |
Related Party Transactions [Abstract] | |
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS | 15. 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 1,500,000 200,000 $0.8 $0.8 In October 2018, the Company entered into an office lease covering approximately 7,250 th The lease is for a term of three years. 60 Initially the Company occupied and paid 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. During 2019, the Company increased the space from 3,275 square feet to 6,232 square feet. In May 2020, the Company reduced the space from 6,232 to 4,554 . The Company is using 1,099 square feet, and Cohen LLC is using approximately 3,455 square feet as of June 30, 2020. The monthly lease payment for 4,554 square feet is $ 22,771 . Of this amount $ 17,277 is charged pro rata to Cohen LLC based on square footage occupied. Additional lease charges for operating expenses and taxes are also charged under the sublease based on the ratio of rent paid by the Company and Cohen LLC to total rent. If the space becomes 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 sublease income related to this agreement of $ 63,000 51,000 132,000 126,000 no amounts due from the related party under this agreement. |
SEGMENT REPORTING
SEGMENT REPORTING | 6 Months Ended |
Jun. 30, 2020 | |
Segment Reporting [Abstract] | |
SEGMENT REPORTING | 16. SEGMENT REPORTING Reportable segments are presented in a manner consistent with the internal reporting provided to the chief operating decision maker (CODM). In April 2020, the Company designated its Chief Executive Officer (CEO) to be its Chief Operating Decision Maker (CODM) and dissolved the function of the Office of the Chief Executive consisting of the President, Chief Operating Officer, and Chief Financial Officer which previously acted as its CODM. The CODM allocates resources to and assesses the performance of each segment using information about its revenue and operating income (loss). These measures are presented in the following tables (in thousands). Asset information by segment is not presented, as this measure is not used by the CODM to assess the segment’s performance. SCHEDULE OF SEGMENT INFORMATION For the Three Months Ended For the Six Months Ended June 30, June 30, 2020 2019 2020 2019 Net revenues by segment: Regenerative medicine $ 944 $ 504 $ 1,372 $ 801 Contract services 1,322 822 1,827 1,990 Total net revenues $ 2,266 $ 1,326 $ 3,199 $ 2,791 Net loss by segment: Regenerative medicine $ (12,567 ) $ (22,572 ) $ (25,270 ) $ (47,781 ) Contract services (110 ) (220 ) (447 ) (584 ) Total net loss $ (12,677 ) $ (22,792 ) $ (25,717 ) $ (48,365 ) |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation |
Use of estimates | Use of estimates |
Cash and cash equivalents | Cash and cash equivalents |
Leases | Leases The Company has lease agreements with lease and non-lease components. As allowed under ASC 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 ASC 842 to leases with a term of 12 months or less for all classes of assets. |
Revenue Recognition | Revenue Recognition The Company records product revenues primarily from the sale of its regenerative tissue products. The Company sells its products to healthcare providers (customers), 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. The Company records service revenues from the sale of its preclinical research services and contract services. Preclinical research services include delivery of preclinical studies and other research services to unrelated third parties. These customer contracts 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 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 due upfront and the remainder upon completion of the contract, with most contracts completing in less than a year. Contract services include research and laboratory testing services to unrelated third parties on a contract basis. These customer contracts generally consist of a single performance obligation that the Company satisfies at a point in time. The Company recognizes revenue upon delivery of testing results to the customer. |
Research and Development Expenses | Research and Development Expenses |
Accruals for Research and Development Expenses and Clinical Trials | Accruals for Research and Development Expenses and Clinical Trials |
Common Stock Warrant Liability | Common Stock Warrant Liability |
Stock-Based Compensation | Stock-Based Compensation The fair value of 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 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 | Loss Per Share 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. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses (Topic 326) Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and Leases (Topic 842): Effective Dates |
Recently Adopted Accounting Pronouncements | Recently Adopted 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 |
FAIR VALUE (Tables)
FAIR VALUE (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
SCHEDULE OF FAIR VALUE OF FINANCIAL INSTRUMENTS MEASURED ON RECURRING BASIS | 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 (in thousands): SCHEDULE OF FAIR VALUE OF FINANCIAL INSTRUMENTS MEASURED ON RECURRING BASIS June 30, 2020 Level 1 Level 2 Level 3 Total Liabilities: Common stock warrant liability $ – $ – $ 8,736 $ 8,736 Total $ – $ – $ 8,736 $ 8,736 December 31, 2019 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 2,019 $ – $ – $ 2,019 Commercial paper – 11,064 – 11,064 Corporate debt securities – 8,982 – 8,982 U.S. government debt securities – 3,770 – 3,770 Total $ 2,019 $ 23,816 $ – $ 25,835 Liabilities: Contingent consideration $ – $ – $ 31 $ 31 Total $ – $ – $ 31 $ 31 |
SCHEDULE OF FAIR VALUE ASSUMPTIONS OF WARRANTS LIABILITY | The following assumptions were used in estimating the fair value of the warrant liability as of June 30, 2020 and upon the issuance date of February 14, 2020: SCHEDULE OF FAIR VALUE ASSUMPTIONS OF WARRANTS LIABILITY June 30, 2020 February 14, 2020 Stock price $ 1.24 $ 1.69 Exercise price $ 2.80 $ 2.80 Risk-free rate 0.45% 1.51% Volatility 97.5% 93.40% Term 6.62 6.99 |
CASH EQUIVALENTS AND SHORT-TE_2
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Cash and Cash Equivalents [Abstract] | |
SCHEDULE OF CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS | Cash equivalents and short-term investments consisted of the following as of December 31, 2019 (in thousands): SCHEDULE OF CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS December 31, 2019 Amortized Cost Unrealized Gains Unrealized Losses Market Value Cash equivalents: Money market funds $ 2,019 $ – $ – $ 2,019 Commercial paper 1,020 4 – 1,024 U.S. government debt securities 3,761 9 – 3,770 Total cash equivalents (1) 6,800 13 – 6,813 Short-term investments: Commercial paper 9,986 54 – 10,040 Corporate debt securities 8,977 5 – 8,982 Total short-term investments 18,963 59 – 19,022 Total $ 25,763 $ 72 $ – $ 25,835 (1) Included in cash and cash equivalents in the Company’s consolidated balance sheet as of December 31, 2019 in addition to $ 3.4 |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Property, Plant and Equipment [Abstract] | |
SCHEDULE OF PROPERTY AND EQUIPMENT, NET | The following table presents the components of property and equipment, net (in thousands): SCHEDULE OF PROPERTY AND EQUIPMENT, NET June 30, 2020 December 31, 2019 Machinery and equipment $ 12,198 $ 12,083 Land and buildings 2,000 2,000 Computers and software 1,255 1,189 Leasehold improvements 3,044 2,282 Construction in progress 179 1,606 Furniture and equipment 233 470 Total property and equipment, gross 18,909 19,630 Accumulated depreciation and amortization (6,180 ) (4,719 ) Total property and equipment, net $ 12,729 $ 14,911 |
SCHEDULE OF DEPRECIATION AND AMORTIZATION EXPENSE | Depreciation and amortization expense for property and equipment, including assets acquired under financing leases was as follows (in thousands): SCHEDULE OF DEPRECIATION AND AMORTIZATION EXPENSE For the Three Months Ended For the Six Months Ended June 30, June 30, 2020 2019 2020 2019 General and administrative expense $ 408 $ 407 $ 800 $ 764 Research and development expense 389 363 749 682 Total depreciation and amortization expense $ 797 $ 770 $ 1,549 $ 1,446 |
LEASES (Tables)
LEASES (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Leases | |
SCHEDULE OF OPERATING AND FINANCE LEASE LIABILITIES | As of June 30, 2020, the maturities of our operating and finance lease liabilities were as follows (in thousands): SCHEDULE OF OPERATING AND FINANCE LEASE LIABILITIES Operating leases Finance leases 2020 (excluding the six months ended June 30, 2020) $ 948 $ 335 2021 1,646 656 2022 1,345 405 2023 132 336 2024 87 42 Total lease payments 4,158 1,774 Less imputed interest (452 ) (242 ) Total lease liabilities $ 3,706 $ 1,532 |
SCHEDULE OF SUPPLEMENTAL BALANCE SHEET INFORMATION RELATED TO FINANCE AND OPERATING LEASES | Supplemental balance sheet information related to leases was as follows (in thousands): Finance leases SCHEDULE OF SUPPLEMENTAL BALANCE SHEET INFORMATION RELATED TO FINANCE AND OPERATING LEASES June 30, 2020 December 31, 2019 Finance lease right-of-use assets included within property and equipment, net $ 1,631 $ 2,177 Current finance lease liabilities included within other current liabilities $ 532 $ 508 Non-current finance lease liabilities included within other long-term liabilities 1,000 1,267 Total finance lease liabilities $ 1,532 $ 1,775 Operating leases June 30, 2020 December 31, 2019 Current operating lease liabilities included within other current liabilities $ 1,514 $ 1,746 Operating lease liabilities – non current 2,192 2,994 Total operating lease liabilities $ 3,706 $ 4,740 |
SUMMARY OF COMPONENTS OF LEASE EXPENSE | The components of lease expense were as follows (in thousands): SUMMARY OF COMPONENTS OF LEASE EXPENSE For the Three Months Ended For the Six Months Ended June 30, June 30, 2020 2019 2020 2019 Operating lease costs included within operating costs and expenses $ 548 $ 546 $ 1,104 $ 1,061 Finance lease costs: Amortization of right-of-use assets $ 174 $ 170 $ 349 $ 309 Interest on lease liabilities 39 44 82 67 Total $ 213 $ 214 $ 431 $ 376 |
SCHEDULE OF SUPPLEMENTAL CASH FLOW INFORMATION RELATED TO LEASES | Supplemental cash flow information related to leases was as follows (in thousands): SCHEDULE OF SUPPLEMENTAL CASH FLOW INFORMATION RELATED TO LEASES For the Six Months Ended June 30, 2020 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash out flows from operating leases $ 1,108 $ 941 Operating cash out flows from finance leases $ 82 $ 67 Financing cash out flows from finance leases $ 243 $ 225 Lease liabilities arising from obtaining right-of-use assets: Finance leases $ – $ 1,824 Lease payments made in prior period reclassified to property and equipment $ – $ 535 Remeasurement of finance lease liability due to lease modification $ – $ (22 ) Operating leases $ – $ 939 Remeasurement of operating lease liability due to lease modification $ 131 $ – |
ACCOUNTS PAYABLE AND ACCRUED _2
ACCOUNTS PAYABLE AND ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES | The following table presents the major components of accounts payable and accrued expenses (in thousands): SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES June 30, 2020 December 31, 2019 Accounts payable $ 423 $ 1,689 Salaries and other compensation 1,815 1,462 Legal and accounting 426 1,404 Accrued severance 1,217 1,053 Benefit plan accrual 560 557 Other 609 930 Total accounts payable and accrued expenses $ 5,050 $ 7,095 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
SCHEDULE OF SHARE-BASED COMPENSATION, STOCK OPTIONS, ACTIVITY | A summary of the Company’s employee and non-employee stock option activity for the six months ended June 30, 2020 is presented below: SCHEDULE OF SHARE-BASED COMPENSATION, STOCK OPTIONS, ACTIVITY Number of Shares Weighted- Average Exercise Price Outstanding – December 31, 2019 4,529,988 $ 15.26 Granted 1,458,026 $ 1.19 Exercised (10,000 ) $ 3.12 Forfeited (867,432 ) $ 11.78 Outstanding – June 30, 2020 5,110,582 $ 11.84 Options exercisable, June 30, 2020 3,603,571 $ 14.87 |
SCHEDULE OF SHARE-BASED COMPENSATION, RESTRICTED STOCK ACTIVITY | A summary of the Company’s employee and non-employee restricted-stock activity is presented below: SCHEDULE OF SHARE-BASED COMPENSATION, RESTRICTED STOCK ACTIVITY Number of Shares Unvested - December 31, 2019 1,843,001 Granted 3,401,036 Vested (1) (832,910 ) Forfeited (79,803 ) Unvested – June 30, 2020 4,331,324 (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. |
SCHEDULE OF SHARE-BASED COMPENSATION RELATED TO RESTRICTED STOCK AWARDS AND STOCK OPTIONS | The stock-based compensation expense related to stock options, restricted stock awards, and the employee stock purchase plan was as follows (in thousands): SCHEDULE OF SHARE-BASED COMPENSATION RELATED TO RESTRICTED STOCK AWARDS AND STOCK OPTIONS For the Three Months Ended For the Six Months Ended June 30, June 30, 2020 2019 2020 2019 General and administrative expense $ 143 $ 6,892 $ 3,220 $ 15,929 Research and development expense 404 1,481 367 2,565 Sales and marketing expense 16 245 197 413 Total stock-based compensation expense $ 563 $ 8,618 $ 3,784 $ 18,907 |
COMMON STOCK WARRANTS (Tables)
COMMON STOCK WARRANTS (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Equity [Abstract] | |
SCHEDULE OF FAIR VALUE OF COMMON STOCK WARRANT LIABILITY | The change in fair value of the common stock warrant liability is presented in the following table and is reported as a change in fair value of common stock warrant liability in the statements of operations (in thousands): SCHEDULE OF FAIR VALUE OF COMMON STOCK WARRANT LIABILITY June 30, 2020 Beginning balance $ – Initial value of common stock warrant liability 11,677 Change in fair value of common stock warrant liability (2,941 ) Ending balance $ 8,736 |
LOSS PER SHARE (Tables)
LOSS PER SHARE (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Earnings Per Share [Abstract] | |
SCHEDULE OF ANTI-DILUTIVE POTENTIAL SHARES OUTSTANDING ACTIVITY | The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per share for the periods presented due to their anti-dilutive effect: SCHEDULE OF ANTI-DILUTIVE POTENTIAL SHARES OUTSTANDING ACTIVITY As of June 30, 2020 2019 Stock options 5,110,582 6,604,461 Restricted stock 4,331,324 493,447 Common stock warrants 10,638,298 – |
SEGMENT REPORTING (Tables)
SEGMENT REPORTING (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Segment Reporting [Abstract] | |
SCHEDULE OF SEGMENT INFORMATION | The CODM allocates resources to and assesses the performance of each segment using information about its revenue and operating income (loss). These measures are presented in the following tables (in thousands). Asset information by segment is not presented, as this measure is not used by the CODM to assess the segment’s performance. SCHEDULE OF SEGMENT INFORMATION For the Three Months Ended For the Six Months Ended June 30, June 30, 2020 2019 2020 2019 Net revenues by segment: Regenerative medicine $ 944 $ 504 $ 1,372 $ 801 Contract services 1,322 822 1,827 1,990 Total net revenues $ 2,266 $ 1,326 $ 3,199 $ 2,791 Net loss by segment: Regenerative medicine $ (12,567 ) $ (22,572 ) $ (25,270 ) $ (47,781 ) Contract services (110 ) (220 ) (447 ) (584 ) Total net loss $ (12,677 ) $ (22,792 ) $ (25,717 ) $ (48,365 ) |
LIQUIDITY AND NEED FOR ADDITI_2
LIQUIDITY AND NEED FOR ADDITIONAL CAPITAL (Details Narrative) - USD ($) $ / shares in Units, $ in Millions | Feb. 14, 2020 | Dec. 19, 2019 | Dec. 05, 2019 | Apr. 10, 2019 | Mar. 31, 2020 | Jun. 30, 2020 | Apr. 12, 2020 | Dec. 31, 2019 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Accumulated deficit | $ 461.1 | |||||||
Cash and cash equivalents and short-term investments | $ 30.5 | |||||||
Public offering share value | 10,638,298 | 3,418,918 | 216,412 | |||||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Public offering price per share | $ 2.35 | $ 8.51 | ||||||
Net proceeds | $ 22.5 | $ 27.9 | ||||||
Public offering value | $ 0.6 | |||||||
Common stock and warrants purchase shares | 10,638,298 | |||||||
Warrant exercise price | $ 2.80 | |||||||
Warrants expiration date | Feb. 12, 2027 | |||||||
Paycheck Protection Program [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Promissory note | $ 3.6 | |||||||
Equity Purchase Agreement [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Public offering share value | 54,090 | |||||||
Public offering price per share | $ 2.31 | |||||||
Public offering value | $ 0.1 | |||||||
Equity Purchase Agreement [Member] | Keystone Capital Partners, LLC [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Common stock, par value | $ 2 | |||||||
Public offering value | $ 25 | |||||||
Agreement term | 36 months |
SCHEDULE OF FAIR VALUE OF FINAN
SCHEDULE OF FAIR VALUE OF FINANCIAL INSTRUMENTS MEASURED ON RECURRING BASIS (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Common stock warrant liability | $ 8,736 | |
Total | 8,736 | 31 |
Money market funds | 2,019 | |
Commercial paper | 11,064 | |
Corporate debt securities | 8,982 | |
U.S. government debt securities | 3,770 | |
Total | 25,835 | |
Contingent consideration | 31 | |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Common stock warrant liability | ||
Total | ||
Money market funds | 2,019 | |
Commercial paper | ||
Corporate debt securities | ||
U.S. government debt securities | ||
Total | 2,019 | |
Contingent consideration | ||
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Common stock warrant liability | ||
Total | ||
Money market funds | ||
Commercial paper | 11,064 | |
Corporate debt securities | 8,982 | |
U.S. government debt securities | 3,770 | |
Total | 23,816 | |
Contingent consideration | ||
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Common stock warrant liability | 8,736 | |
Total | $ 8,736 | 31 |
Money market funds | ||
Commercial paper | ||
Corporate debt securities | ||
U.S. government debt securities | ||
Total | ||
Contingent consideration | $ 31 |
SCHEDULE OF FAIR VALUE ASSUMPTI
SCHEDULE OF FAIR VALUE ASSUMPTIONS OF WARRANTS LIABILITY (Details) - $ / shares | Feb. 14, 2020 | Jun. 30, 2020 |
Fair Value Disclosures [Abstract] | ||
Stock price | $ 1.69 | $ 1.24 |
Exercise price | $ 2.80 | $ 2.80 |
Risk-free rate | 1.51% | 0.45% |
Volatility | 93.40% | 97.50% |
Term | 6 years 11 months 26 days | 6 years 7 months 13 days |
FAIR VALUE (Details Narrative)
FAIR VALUE (Details Narrative) - USD ($) $ in Thousands | Jun. 30, 2020 | Feb. 14, 2020 | Dec. 31, 2019 |
Acquired Indefinite-lived Intangible Assets [Line Items] | |||
Fair value of warrant liability | $ 8,700 | $ 11,700 | |
IBEX [Member] | |||
Acquired Indefinite-lived Intangible Assets [Line Items] | |||
Contingent consideration payment of actual revenues received | $ 31 |
SCHEDULE OF CASH EQUIVALENTS AN
SCHEDULE OF CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 | |
SEC Schedule, 12-15, Insurance Companies, Summary of Investments, Other than Investments in Related Parties [Line Items] | |||
Money market funds | $ 2,019 | ||
Commercial paper | 1,024 | ||
U.S. government debt securities | 3,770 | ||
Total cash equivalents | [1] | 6,813 | |
Commercial paper | 10,040 | ||
Corporate debt securities | 8,982 | ||
Total short-term investments | 19,022 | ||
Total | 25,835 | ||
Additional cash and cash equivalents | 3,400 | ||
Amortized Cost [Member] | |||
SEC Schedule, 12-15, Insurance Companies, Summary of Investments, Other than Investments in Related Parties [Line Items] | |||
Money market funds | 2,019 | ||
Commercial paper | 1,020 | ||
U.S. government debt securities | 3,761 | ||
Total cash equivalents | [1] | 6,800 | |
Commercial paper | 9,986 | ||
Corporate debt securities | 8,977 | ||
Total short-term investments | 18,963 | ||
Total | 25,763 | ||
Unrealized Gains [Member] | |||
SEC Schedule, 12-15, Insurance Companies, Summary of Investments, Other than Investments in Related Parties [Line Items] | |||
Money market funds | |||
Commercial paper | 4 | ||
U.S. government debt securities | 9 | ||
Total cash equivalents | [1] | 13 | |
Commercial paper | 54 | ||
Corporate debt securities | 5 | ||
Total short-term investments | 59 | ||
Total | 72 | ||
Unrealized Losses [Member] | |||
SEC Schedule, 12-15, Insurance Companies, Summary of Investments, Other than Investments in Related Parties [Line Items] | |||
Money market funds | |||
Commercial paper | |||
U.S. government debt securities | |||
Total cash equivalents | [1] | ||
Commercial paper | |||
Corporate debt securities | |||
Total short-term investments | |||
Total | |||
[1] | Included in cash and cash equivalents in the Company’s consolidated balance sheet as of December 31, 2019 in addition to $ 3.4 |
CASH EQUIVALENTS AND SHORT-TE_3
CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (Details Narrative) - USD ($) $ in Millions | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Cash and Cash Equivalents [Abstract] | ||
Realized gains on available-for-sale securities | $ 0.1 | $ 0.3 |
SCHEDULE OF PROPERTY AND EQUIPM
SCHEDULE OF PROPERTY AND EQUIPMENT, NET (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Abstract] | ||
Machinery and equipment | $ 12,198 | $ 12,083 |
Land and buildings | 2,000 | 2,000 |
Computers and software | 1,255 | 1,189 |
Leasehold improvements | 3,044 | 2,282 |
Construction in progress | 179 | 1,606 |
Furniture and equipment | 233 | 470 |
Total property and equipment, gross | 18,909 | 19,630 |
Accumulated depreciation and amortization | (6,180) | (4,719) |
Total property and equipment, net | $ 12,729 | $ 14,911 |
SCHEDULE OF DEPRECIATION AND AM
SCHEDULE OF DEPRECIATION AND AMORTIZATION EXPENSE (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Impaired Assets to be Disposed of by Method Other than Sale [Line Items] | ||||
Total depreciation and amortization expense | $ 797 | $ 770 | $ 1,549 | $ 1,446 |
General and Administrative Expense [Member] | ||||
Impaired Assets to be Disposed of by Method Other than Sale [Line Items] | ||||
Total depreciation and amortization expense | 408 | 407 | 800 | 764 |
Research and Development Expense [Member] | ||||
Impaired Assets to be Disposed of by Method Other than Sale [Line Items] | ||||
Total depreciation and amortization expense | $ 389 | $ 363 | $ 749 | $ 682 |
PROPERTY AND EQUIPMENT, NET (De
PROPERTY AND EQUIPMENT, NET (Details Narrative) $ in Millions | 6 Months Ended |
Jun. 30, 2020USD ($) | |
Property, Plant and Equipment [Abstract] | |
Construction in progress and other equipment | $ 1.5 |
SCHEDULE OF OPERATING AND FINAN
SCHEDULE OF OPERATING AND FINANCE LEASE LIABILITIES (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Leases | ||
Operating leases, 2020 (excluding the six months ended June 30, 2020) | $ 948 | |
Finance leases, 2020 (excluding the six months ended June 30, 2020) | 335 | |
Operating leases, 2021 | 1,646 | |
Finance leases, 2021 | 656 | |
Operating leases, 2022 | 1,345 | |
Finance leases, 2022 | 405 | |
Operating leases, 2023 | 132 | |
Finance leases, 2023 | 336 | |
Operating leases, 2024 | 87 | |
Finance leases, 2024 | 42 | |
Operating leases, Total lease payments | 4,158 | |
Finance leases, Total lease payments | 1,774 | |
Operating leases, Less: Imputed interest | (452) | |
Finance leases, Less: Imputed interest | (242) | |
Operating leases, Total lease liabilities | 3,706 | $ 4,740 |
Finance leases, Total lease liabilities | $ 1,532 | $ 1,775 |
SCHEDULE OF SUPPLEMENTAL BALANC
SCHEDULE OF SUPPLEMENTAL BALANCE SHEET INFORMATION RELATED TO FINANCE AND OPERATING LEASES (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Leases | ||
Finance lease right-of-use assets included within property and equipment, net | $ 1,631 | $ 2,177 |
Current finance lease liabilities included within other current liabilities | 532 | 508 |
Non-current finance lease liabilities included within other long-term liabilities | 1,000 | 1,267 |
Total finance lease liabilities | 1,532 | 1,775 |
Current operating lease liabilities included within other current liabilities | 1,514 | 1,746 |
Operating lease liabilities – non current | 2,192 | 2,994 |
Total operating lease liabilities | $ 3,706 | $ 4,740 |
SUMMARY OF COMPONENTS OF LEASE
SUMMARY OF COMPONENTS OF LEASE EXPENSE (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Leases | ||||
Operating lease costs included within operating costs and expenses | $ 548 | $ 546 | $ 1,104 | $ 1,061 |
Amortization of right-of-use assets | 174 | 170 | 349 | 309 |
Interest on lease liabilities | 39 | 44 | 82 | 67 |
Total | $ 213 | $ 214 | $ 431 | $ 376 |
SCHEDULE OF SUPPLEMENTAL CASH F
SCHEDULE OF SUPPLEMENTAL CASH FLOW INFORMATION RELATED TO LEASES (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Leases | ||
Operating cash out flows from operating leases | $ 1,108 | $ 941 |
Operating cash out flows from finance leases | 82 | 67 |
Financing cash out flows from finance leases | 243 | 225 |
Finance leases | 1,824 | |
Lease payments made in prior period reclassified to property and equipment | 535 | |
Remeasurement of finance lease liability due to lease modification | (22) | |
Operating leases | 939 | |
Remeasurement of operating lease liability due to lease modification | $ 131 |
LEASES (Details Narrative)
LEASES (Details Narrative) | 6 Months Ended | |
Jun. 30, 2020 | Dec. 31, 2019 | |
Leases | ||
Leases facilities, description | 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. | |
Operating Lease, Weighted Average Remaining Lease Term | 2 years 6 months | 2 years 9 months 18 days |
Operating Lease, Weighted Average Discount Rate, Percent | 9.76% | 9.83% |
Finance Lease, Weighted Average Remaining Lease Term | 3 years | 3 years 6 months |
Finance Lease, Weighted Average Discount Rate, Percent | 9.77% |
SCHEDULE OF ACCOUNTS PAYABLE AN
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 423 | $ 1,689 |
Salaries and other compensation | 1,815 | 1,462 |
Legal and accounting | 426 | 1,404 |
Accrued severance | 1,217 | 1,053 |
Benefit plan accrual | 560 | 557 |
Other | 609 | 930 |
Total accounts payable and accrued expenses | $ 5,050 | $ 7,095 |
ACCOUNTS PAYABLE AND ACCRUED _3
ACCOUNTS PAYABLE AND ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details Narrative) $ in Millions | Jun. 30, 2020USD ($) |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Short-term Debt | $ 0.6 |
Financing Arrangements One [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Short-term Debt | $ 0.8 |
Debt Instrument, Interest Rate, Stated Percentage | 4.25% |
Financing Arrangements Two [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Short-term Debt | $ 0.2 |
Debt Instrument, Interest Rate, Stated Percentage | 6.35% |
SCHEDULE OF SHARE-BASED COMPENS
SCHEDULE OF SHARE-BASED COMPENSATION, STOCK OPTIONS, ACTIVITY (Details) - Employee and Non-Employee Stock Option [Member] | 6 Months Ended |
Jun. 30, 2020$ / sharesshares | |
Option Indexed to Issuer's Equity [Line Items] | |
Number of Shares, Outstanding at beginning of period | shares | 4,529,988 |
Weighted Average Exercise Price, Outstanding at beginning of period | $ / shares | $ 15.26 |
Number of Shares, Granted | shares | 1,458,026 |
Weighted Average Exercise Price, Granted | $ / shares | $ 1.19 |
Number of Shares, Exercised | shares | (10,000) |
Weighted Average Exercise Price, Exercised | $ / shares | $ 3.12 |
Number of Shares, Forfeited | shares | (867,432) |
Weighted Average Exercise Price, Forfeited | $ / shares | $ 11.78 |
Number of Shares, Outstanding at end of period | shares | 5,110,582 |
Weighted Average Exercise Price, Outstanding at end of period | $ / shares | $ 11.84 |
Number of Shares, Options exercisable | shares | 3,603,571 |
Weighted Average Exercise Price, Options exercisable | $ / shares | $ 14.87 |
SCHEDULE OF SHARE-BASED COMPE_2
SCHEDULE OF SHARE-BASED COMPENSATION, RESTRICTED STOCK ACTIVITY (Details) - Restricted Stock [Member] | 6 Months Ended | |
Jun. 30, 2020shares | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of Shares, Unvested at beginning of period | 1,843,001 | |
Number of Shares, Granted | 3,401,036 | |
Number of Shares, Vested | (832,910) | [1] |
Number of Shares, Forfeited | (79,803) | |
Number of Shares, Unvested at end of period | 4,331,324 | |
[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. |
SCHEDULE OF SHARE-BASED COMPE_3
SCHEDULE OF SHARE-BASED COMPENSATION RELATED TO RESTRICTED STOCK AWARDS AND STOCK OPTIONS (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 563 | $ 8,618 | $ 3,784 | $ 18,907 |
General and Administrative Expense [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 143 | 6,892 | 3,220 | 15,929 |
Research and Development Expense [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 404 | 1,481 | 367 | 2,565 |
Selling and Marketing Expense [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 16 | $ 245 | $ 197 | $ 413 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details Narrative) - shares | Oct. 25, 2019 | Oct. 05, 2018 | Dec. 01, 2016 | May 31, 2018 | Jun. 30, 2020 |
2020 Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock based compensation terminate date | Dec. 19, 2029 | ||||
Number of share available for future issuance | 18,000 | ||||
2020 Equity Incentive Plan [Member] | Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of stock issuable | 3,000,000 | ||||
2019 Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock based compensation terminate date | Oct. 5, 2028 | ||||
Number of share available for future issuance | 257,570 | ||||
2019 Equity Incentive Plan [Member] | Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of stock issuable | 3,000,000 | ||||
2017 Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock based compensation terminate date | Dec. 1, 2026 | ||||
Number of share available for future issuance | 1,177,365 | ||||
2017 Equity Incentive Plan [Member] | Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of stock issuable | 7,300,000 | ||||
Employee Stock Purchase Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares reserved | 500,000 | ||||
Common stock purchase price percentage | 85.00% |
SCHEDULE OF FAIR VALUE OF COMMO
SCHEDULE OF FAIR VALUE OF COMMON STOCK WARRANT LIABILITY (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2020USD ($) | |
Equity [Abstract] | |
Beginning balance | |
Initial value of common stock warrant liability | 11,677 |
Change in fair value of common stock warrant liability | (2,941) |
Ending balance | $ 8,736 |
COMMON STOCK WARRANTS (Details
COMMON STOCK WARRANTS (Details Narrative) - $ / shares | Feb. 14, 2020 | Feb. 14, 2020 | Apr. 10, 2019 | Mar. 31, 2020 |
Subsidiary, Sale of Stock [Line Items] | ||||
Number of common stock issued | 10,638,298 | 3,418,918 | 216,412 | |
Warrants to pruchase from common stock | 10,638,298 | 10,638,298 | ||
Shares issued price per share | $ 2.35 | $ 2.35 | $ 8.51 | |
Warrants price per | $ 2.80 | $ 2.80 | ||
Warrants expiration date | Feb. 12, 2027 | Feb. 12, 2027 | ||
Underwritten Offering [Member] | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Number of common stock issued | 10,638,298 | |||
Shares issued price per share | $ 2.35 | $ 2.35 |
SCHEDULE OF ANTI-DILUTIVE POTEN
SCHEDULE OF ANTI-DILUTIVE POTENTIAL SHARES OUTSTANDING ACTIVITY (Details) - shares | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive shares | 5,110,582 | 6,604,461 |
Restricted Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive shares | 4,331,324 | 493,447 |
Common Stock Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive shares | 10,638,298 |
DEBT (Details Narrative)
DEBT (Details Narrative) - Paycheck Protection Program [Member] | Apr. 12, 2020USD ($) |
Short-term Debt [Line Items] | |
Unsecured Debt | $ 3,576,145 |
Debt Instrument, Interest Rate, Stated Percentage | 1.00% |
Debt Instrument, Term | 24 months |
Debt Instrument, Periodic Payment | $ 150,563 |
RESTRUCTURING (Details Narrativ
RESTRUCTURING (Details Narrative) $ in Millions | 3 Months Ended | 6 Months Ended |
Jun. 30, 2020USD ($) | Jun. 30, 2020USD ($) | |
Restructuring and Related Activities [Abstract] | ||
Percentage of reduction in workforce | 31.70% | 31.70% |
Severance Costs | $ 0.6 | $ 1 |
Loss on abandonment of assets | $ 1.5 | $ 1.5 |
CERTAIN RELATIONSHIPS AND REL_2
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS (Details Narrative) | Aug. 21, 2019 | Oct. 31, 2018USD ($)ft² | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($)shares | Jun. 30, 2019USD ($) | May 31, 2020ft² | Dec. 31, 2019ft² | Oct. 02, 2019USD ($) |
SEC Schedule, 12-18, Supplemental Information, Property-Casualty Insurance Underwriters [Line Items] | |||||||||
Future cash payments | $ 800,000 | ||||||||
Lease rental square feet | ft² | 6,232 | ||||||||
Lease term, description | 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. | ||||||||
Annual lease rate | $ 22,771 | ||||||||
Sublease income | $ 63,000 | $ 51,000 | 132,000 | $ 126,000 | |||||
Due from Related Parties | $ 0 | 0 | |||||||
Cohen LLC [Member] | |||||||||
SEC Schedule, 12-18, Supplemental Information, Property-Casualty Insurance Underwriters [Line Items] | |||||||||
Lease rental square feet | ft² | 3,455 | ||||||||
Annual lease rate | $ 17,277 | ||||||||
Operating leases, description | If the space becomes fully occupied, the Company will reduce the overall annual lease rate for the Cohen LLC space to $58.60 per square foot. | ||||||||
Parent Company [Member] | |||||||||
SEC Schedule, 12-18, Supplemental Information, Property-Casualty Insurance Underwriters [Line Items] | |||||||||
Lease rental square feet | ft² | 1,099 | ||||||||
Reduction in Space [Member] | Minimum [Member] | |||||||||
SEC Schedule, 12-18, Supplemental Information, Property-Casualty Insurance Underwriters [Line Items] | |||||||||
Lease rental square feet | ft² | 6,232 | ||||||||
Reduction in Space [Member] | Maximum [Member] | |||||||||
SEC Schedule, 12-18, Supplemental Information, Property-Casualty Insurance Underwriters [Line Items] | |||||||||
Lease rental square feet | ft² | 4,554 | ||||||||
Office Lease [Member] | |||||||||
SEC Schedule, 12-18, Supplemental Information, Property-Casualty Insurance Underwriters [Line Items] | |||||||||
Lease rental square feet | ft² | 7,250 | ||||||||
Lease term, description | The lease is for a term of three years. | ||||||||
Annual lease rate | $ 60 | ||||||||
Operating leases, description | Initially the Company occupied and paid 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. | ||||||||
Dr. Denver Lough [Member] | |||||||||
SEC Schedule, 12-18, Supplemental Information, Property-Casualty Insurance Underwriters [Line Items] | |||||||||
Number of restricted stock | shares | 200,000 | ||||||||
Fair value of restricted stock | $ 800,000 | ||||||||
Settlement Terms Agreement [Member] | Dr. Denver Lough [Member] | |||||||||
SEC Schedule, 12-18, Supplemental Information, Property-Casualty Insurance Underwriters [Line Items] | |||||||||
Related party transaction, description | 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. | ||||||||
Due to related party | $ 1,500,000 | ||||||||
Settlement Terms Agreement [Member] | Dr. Denver Lough [Member] | Equal Monthly Installments Beginning November 1, 2019 and Ending April 1, 2021 [Member] | |||||||||
SEC Schedule, 12-18, Supplemental Information, Property-Casualty Insurance Underwriters [Line Items] | |||||||||
Due to related party | $ 1,500,000 |
SCHEDULE OF SEGMENT INFORMATION
SCHEDULE OF SEGMENT INFORMATION (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Segment Reporting Information [Line Items] | ||||||
Total net revenues | $ 2,266 | $ 1,326 | $ 3,199 | $ 2,791 | ||
Total net loss | (12,677) | $ (13,040) | (22,792) | $ (25,573) | (25,717) | (48,365) |
Regenerative Medicine [Member] | ||||||
Segment Reporting Information [Line Items] | ||||||
Total net revenues | 944 | 504 | 1,372 | 801 | ||
Total net loss | (12,567) | (22,572) | (25,270) | (47,781) | ||
Contract Services [Member] | ||||||
Segment Reporting Information [Line Items] | ||||||
Total net revenues | 1,322 | 822 | 1,827 | 1,990 | ||
Total net loss | $ (110) | $ (220) | $ (447) | $ (584) |