Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 02, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2021 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2021 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-38552 | |
Entity Registrant Name | PROVENTION BIO, INC. | |
Entity Central Index Key | 0001695357 | |
Entity Tax Identification Number | 81-5245912 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 55 Broad Street | |
Entity Address, Address Line Two | 2nd Floor | |
Entity Address, City or Town | Red Bank | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 07701 | |
City Area Code | (908) | |
Local Phone Number | 336-0360 | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Trading Symbol | PRVB | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 63,374,738 |
Condensed Balance Sheets (Unaud
Condensed Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 151,781 | $ 102,294 |
Marketable securities | 24,597 | 19,530 |
Prepaid expenses and other current assets | 4,209 | 4,730 |
Total current assets | 180,587 | 126,554 |
Fixed assets, net | 2,208 | 1,437 |
Operating lease right-of-use assets | 393 | 408 |
Other assets | 120 | 120 |
Total assets | 183,308 | 128,519 |
Current liabilities: | ||
Accounts payable | 3,866 | 7,568 |
Accrued expenses and other current liabilities | 13,767 | 9,162 |
Deferred revenue | 7,000 | |
Total current liabilities | 24,633 | 16,730 |
Operating lease liabilities, long-term | 655 | 715 |
Total liabilities | 25,288 | 17,445 |
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value; 25,000,000 shares authorized; no shares issued or outstanding at June 30, 2021 and December 31, 2020 | ||
Common stock, $0.0001 par value; 150,000,000 shares authorized; 63,374,738 shares issued and outstanding at June 30, 2021; 100,000,000 shares authorized; 56,517,891 shares issued and outstanding at December 31, 2020 | 6 | 6 |
Additional paid-in capital | 397,226 | 288,725 |
Accumulated other comprehensive gain (loss) | 12 | (15) |
Accumulated deficit | (239,224) | (177,642) |
Total stockholders’ equity | 158,020 | 111,074 |
Total liabilities and stockholders’ equity | $ 183,308 | $ 128,519 |
Condensed Balance Sheets (Una_2
Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 |
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 or Stated Value Per Share | $ 0.0001 | $ 0.0001 |
Common Stock, Shares Authorized | 150,000,000 | 100,000,000 |
Common Stock, Shares, Issued | 63,374,738 | 56,517,891 |
Common Stock, Shares, Outstanding | 63,374,738 | 56,517,891 |
Condensed Statements of Compreh
Condensed Statements of Comprehensive Loss (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Operating expenses: | ||||
Research and development | $ 16,968 | $ 15,032 | $ 36,655 | $ 24,122 |
General and administrative | 13,205 | 7,764 | 25,986 | 11,539 |
Total operating expenses | 30,173 | 22,796 | 62,641 | 35,661 |
Loss from operations | (30,173) | (22,796) | (62,641) | (35,661) |
Interest income, net | 31 | 151 | 59 | 434 |
Loss before income tax benefit | (30,142) | (22,645) | (62,582) | (35,227) |
Income tax benefit | 1,000 | 523 | 1,000 | 523 |
Net loss | $ (29,142) | $ (22,122) | $ (61,582) | $ (34,704) |
Net loss per common share, basic and diluted | $ (0.46) | $ (0.45) | $ (0.98) | $ (0.72) |
Weighted average common shares outstanding, basic and diluted | 63,375 | 49,199 | 62,822 | 48,449 |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on marketable securities | $ 28 | $ (112) | $ 27 | $ 98 |
Total comprehensive loss | $ (29,114) | $ (22,234) | $ (61,555) | $ (34,606) |
Condensed Statement of Stockhol
Condensed Statement of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2019 | $ 5 | $ 161,212 | $ (79,061) | $ 82,156 | |
Beginning balance, shares at Dec. 31, 2019 | 47,658,000 | ||||
Issuance of common stock in connection with underwritten public offering, net of issuance costs | $ 1 | 103,269 | 103,270 | ||
Issuance of common stock in connection with underwritten public offering, net of issuance costs, shares | 7,590,000 | ||||
Issuance of common stock in connection with at-the-market stock sales, net of issuance costs | 9,869 | 9,869 | |||
Issuance of common stock in connection with at-the-market stock sales, net of issuance costs, shares | 725,000 | ||||
Issuance of common stock in connection with warrant exercises | |||||
Issuance of common stock in connection with warrant exercises, shares | 130,000 | ||||
Issuance of common stock in connection with stock option exercises | 574 | 574 | |||
Issuance of common stock in connection with stock option exercises, shares | 113,000 | ||||
Unrealized gain (loss) on marketable securities, net of tax | 98 | 98 | |||
Stock-based compensation | 2,513 | 2,513 | |||
Net loss | (34,704) | (34,704) | |||
Ending balance, value at Jun. 30, 2020 | $ 6 | 277,437 | 98 | (113,765) | 163,776 |
Shares, Outstanding, Ending Balance at Jun. 30, 2020 | 56,216,000 | ||||
Beginning balance, value at Mar. 31, 2020 | $ 5 | 162,642 | 210 | (91,643) | 71,214 |
Beginning balance, shares at Mar. 31, 2020 | 47,713,000 | ||||
Issuance of common stock in connection with underwritten public offering, net of issuance costs | $ 1 | 103,269 | 103,270 | ||
Issuance of common stock in connection with underwritten public offering, net of issuance costs, shares | 7,590,000 | ||||
Issuance of common stock in connection with at-the-market stock sales, net of issuance costs | 9,869 | 9,869 | |||
Issuance of common stock in connection with at-the-market stock sales, net of issuance costs, shares | 725,000 | ||||
Issuance of common stock in connection with warrant exercises | |||||
Issuance of common stock in connection with warrant exercises, shares | 130,000 | ||||
Issuance of common stock in connection with stock option exercises | 380 | 380 | |||
Issuance of common stock in connection with stock option exercises, shares | 58,000 | ||||
Unrealized gain (loss) on marketable securities, net of tax | (112) | (112) | |||
Stock-based compensation | 1,277 | 1,277 | |||
Net loss | (22,122) | (22,122) | |||
Ending balance, value at Jun. 30, 2020 | $ 6 | 277,437 | 98 | (113,765) | 163,776 |
Shares, Outstanding, Ending Balance at Jun. 30, 2020 | 56,216,000 | ||||
Beginning balance, value at Dec. 31, 2020 | $ 6 | 288,725 | (15) | (177,642) | 111,074 |
Beginning balance, shares at Dec. 31, 2020 | 56,518,000 | ||||
Issuance of common stock in connection with underwritten public offering, net of issuance costs | 102,329 | 102,329 | |||
Issuance of common stock in connection with underwritten public offering, net of issuance costs, shares | 6,838,000 | ||||
Issuance of common stock in connection with stock option exercises | 48 | $ 48 | |||
Issuance of common stock in connection with stock option exercises, shares | 19,000 | 19 | |||
Unrealized gain (loss) on marketable securities, net of tax | 27 | $ 27 | |||
Stock-based compensation | 6,124 | 6,124 | |||
Net loss | (61,582) | (61,582) | |||
Ending balance, value at Jun. 30, 2021 | $ 6 | 397,226 | 12 | (239,224) | 158,020 |
Shares, Outstanding, Ending Balance at Jun. 30, 2021 | 63,375,000 | ||||
Beginning balance, value at Mar. 31, 2021 | $ 6 | 393,959 | (16) | (210,082) | 183,867 |
Beginning balance, shares at Mar. 31, 2021 | 63,375,000 | ||||
Unrealized gain (loss) on marketable securities, net of tax | 28 | 28 | |||
Stock-based compensation | 3,267 | 3,267 | |||
Net loss | (29,142) | (29,142) | |||
Ending balance, value at Jun. 30, 2021 | $ 6 | $ 397,226 | $ 12 | $ (239,224) | $ 158,020 |
Shares, Outstanding, Ending Balance at Jun. 30, 2021 | 63,375,000 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Operating activities | ||||
Net loss | $ (29,142) | $ (22,122) | $ (61,582) | $ (34,704) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Stock-based compensation expense | 3,267 | 1,277 | 6,124 | 2,513 |
Amortization of premium and discounts on marketable securities | 327 | 44 | ||
Non-cash operating lease expense | (4) | |||
Depreciation | 100 | 154 | ||
Changes in operating assets and liabilities: | ||||
Prepaid expenses and other current assets | 521 | (2,977) | ||
Accounts payable | (3,702) | 6,053 | ||
Accrued interest receivable | 17 | 43 | ||
Accrued expenses | 4,564 | 2,086 | ||
Deferred revenue | 7,000 | |||
Net cash used in operating activities | (46,581) | (26,942) | ||
Investing activities | ||||
Purchase of marketable securities | (16,324) | (9,049) | ||
Maturities of marketable securities | 10,940 | 29,000 | ||
Purchase of fixed assets | (925) | |||
Net cash (used in) provided by investing activities | (6,309) | 19,951 | ||
Financing activities | ||||
Proceeds from underwritten public offering, net | 102,329 | 103,270 | ||
Proceeds from at-the-market stock sales, net | 9,869 | |||
Proceeds from stock option exercises | 380 | 48 | 574 | |
Net cash provided by financing activities | 102,377 | 113,713 | ||
Net increase in cash and cash equivalents | 49,487 | 106,722 | ||
Cash and cash equivalents at beginning of period | 102,294 | 39,165 | ||
Cash and cash equivalents at end of period | $ 151,781 | $ 145,887 | 151,781 | 145,887 |
Supplemental disclosure of cash flow information: | ||||
Operating cash flows used for operating leases | $ 77 |
DESCRIPTION OF BUSINESS AND BAS
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION | 1. DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION Business Provention Bio, Inc. (the “Company”) was incorporated on October 4, 2016 under the laws of the State of Delaware. The Company is a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases. Since its inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, acquiring operating assets and raising capital. The Company’s business is subject to significant risks and uncertainties and will be dependent on raising substantial additional capital before it becomes profitable, and it may never achieve profitability. Basis of presentation The accompanying unaudited financial information as of June 30, 2021 and for the three and six months ended June 30, 2021 and 2020 has been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. The December 31, 2020 Condensed Balance Sheet was derived from the Company’s audited financial statements. These interim financial statements should be read in conjunction with the notes to the financial statements contained in the Company’s Annual Report on Form 10-K (“Annual Report”) for 2020, as filed with the SEC on February 25, 2021. In the opinion of management, the unaudited financial information as of June 30, 2021 and for the three and six months ended June 30, 2021 and 2020, reflects all adjustments, which are normal recurring adjustments, necessary to present a fair statement of the financial position, results of operations and cash flows of the Company. The results of operations for the three and six months ended June 30, 2021 and 2020 are not necessarily indicative of the operating results for the full fiscal year or any future period. |
LIQUIDITY
LIQUIDITY | 6 Months Ended |
Jun. 30, 2021 | |
Liquidity | |
LIQUIDITY | 2. LIQUIDITY The accompanying financial statements have been prepared assuming the Company will continue as a going concern, which contemplates continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company has incurred recurring losses since inception and as of June 30, 2021, the Company had an accumulated deficit of $ 239.2 million . In January 2021, the Company completed an underwritten public offering in which it sold 6,250,000 16.00 587,500 16.00 102.3 6.6 0.5 In February 2021, the Company established a new at-the-market program (the “2021 ATM Program”) through which the Company may sell, from time to time at its sole discretion, up to $ 150.0 725,495 9.9 0.3 The Company has devoted substantially all of its financial resources and efforts to research and development and expects to continue to incur significant expenses and increasing operating losses over the next several years due to, among other things, costs related to research funding, development of its product candidates, strategic alliances, the development of its administrative and commercial organization and pre-commercial activities for teplizumab . The Company will require substantial additional financing to fund its operations and to continue to execute its strategy. The Company may raise capital through public or private equity or debt financings. The sale of equity or other securities may result in dilution to the Company’s stockholders and certain of those securities may have rights senior to those of the Company’s existing shares. If the Company raises additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict the Company’s operations. Any other third-party funding arrangement could require the Company to relinquish valuable rights. The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of the Company’s clinical development programs. Funding may not be available when needed, at all, or on terms acceptable to the Company. Lack of necessary funds may require the Company, among other things, to delay, scale back or eliminate some or all of the Company’s planned operations. The Company’s cash requirements for the rest of 2021 and into 2022 will be impacted by a number of factors, the most significant of which are expenses related to teplizumab, including costs and timing of the Company’s regulatory activities, costs to build out the Company’s commercial infrastructure and pre-commercial activities for teplizumab, the PROTECT clinical trial, manufacturing activities for teplizumab and any potential milestone payments that may become due upon a potential regulatory approval of teplizumab by the FDA. Other factors include costs related to the Company’s other ongoing or planned clinical trials, such as the Phase 2b PROACTIVE clinical study of PRV-015 in celiac disease, the first-in-human PROVENT study of its PRV-101 polyvalent inactivated coxsackievirus B vaccine candidate, and the planned Phase 2a PREVAIL clinical study of PRV-3279 in lupus. Depending on the timing and outcome of the Company’s regulatory activities and the status of its plans to prepare for a potential regulatory approval of teplizumab by the FDA, the Company may encounter near-term liquidity needs that could impact its cash runway over the next 12 months. If the Company does not obtain additional financing, or prudently manage its expenses, the Company’s financial condition, cash flows and results of operations could be materially and adversely affected. Based on the Company’s current business plans, management believes that its cash, cash equivalents and marketable securities on hand at June 30, 2021, are sufficient to meet the Company’s obligations for at least the next 12 months from the issuance of these financial statements. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | 3. SIGNIFICANT ACCOUNTING POLICIES A summary of the significant accounting policies followed by the Company in the preparation of the financial statements is as follows: Use of estimates The process of preparing financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of assets and liabilities at the date of financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates and changes in estimates may occur. Segment and geographic information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one Cash, cash equivalents and concentration of credit risk The Company considers only those investments which are highly liquid, readily convertible to cash, or that mature within 90 days from the date of purchase to be cash equivalents. Marketable securities are those investments with original maturities in excess of 90 days. The carrying amounts reported in the balance sheets for cash and cash equivalents are valued at cost, which approximates their fair value. The Company has no off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements. The Company holds cash and cash equivalents in banks in excess of FDIC insurance limits. However, the Company believes risk of loss is minimal as the cash and cash equivalents are held by large, highly-rated financial institutions. Marketable securities The Company considers securities with original maturities of greater than 90 days to be available for sale securities. Available for sale securities are classified as either current or non-current assets based on the nature of the securities and their availability for use in current operations. Available for sale securities are recorded at fair value and unrealized gains and losses are recorded within accumulated other comprehensive income. The estimated fair value of the available for sale securities is determined based on quoted market prices or rates for similar instruments. In addition, the cost of debt securities in this category is adjusted for amortization of premium and accretion of discount to maturity. On a quarterly basis, the Company reviews the status of each security in an unrealized loss position, to evaluate the existence of potential credit losses. The Company first considers whether it intends to sell, or if it is more likely than not that the Company will be required to sell the security before recovery of its amortized cost basis. If either of the criteria regarding intent or requirement to sell is met, the security’s amortized cost basis is written down to fair value through income. For securities that do not meet this criteria, the Company considers a number of factors to determine if the decline in fair value has resulted from credit losses or other factors, including but not limited to: (1) the extent of the decline; (2) changes to the rating of the security by a rating agency; (3) any adverse conditions specific to the security; and (4) other market conditions that may affect the fair value of the security. If this assessment indicates that a credit loss exists and the present value of cash flows expected to be collected is less than the amortized cost basis, an allowance for credit losses is required for the credit loss. Any impairment that has not been recorded through an allowance for credit losses is recognized in other comprehensive income. As of June 30, 2021, the Company has not recognized any impairment or credit losses on its available for sale securities. Financial instruments Cash, cash equivalents and marketable securities are reflected in the accompanying financial statements at fair value. The carrying amount of accounts payable and accrued expenses, including accrued research and development expenses, approximates fair value due to the short-term nature of those instruments. Fixed assets, net Fixed assets, which consists primarily of leasehold improvements, furniture and fixtures, software, office equipment and certain clinical equipment, are carried at cost less accumulated depreciation. Depreciation is computed over the estimated useful lives of the respective assets, generally three seven Leases The Company determines if an arrangement is a lease at contract inception. A lease is a contract, or part of a contract, that conveys the right to control the use of explicitly or implicitly identified property, plant or equipment in exchange for consideration. Control of an underlying asset is conveyed to the Company if the Company obtains the rights to direct the use of and to obtain substantially all of the economic benefits from using the underlying asset. The Company classifies its leases as operating or financing by considering factors such as the length of the lease term, the present value of the lease payments, the specialized nature of the asset being leased and the potential for ownership of the asset to transfer during the lease term. Leases with terms greater than one-year are recognized on the Company’s balance sheets as right-of-use (“ROU”) assets and lease liabilities and are measured at the present value of the fixed payments due over the lease term minus the present value of any incentives, rebates or abatements expected to be received from the lessor. Options to extend a lease are typically excluded from the expected lease term as the exercise of the option is typically not reasonably certain. Leases are measured at present value using the rate implicit in the lease or, if the implicit rate is not determinable, the lessee’s incremental borrowing rate. As the implicit rate is not typically readily determinable, the Company uses an incremental borrowing rate, which is established based upon the information available at the lease commencement date, to determine the present value of lease payments due under an arrangement. The incremental borrowing rate approximates the rate the Company would pay to borrow on a collateralized basis over a similar term and amount equal to the lease payments. ROU assets are amortized on a straight-line basis over the term of the lease. Lease liabilities accrete to yield and are reduced at the time when the lease payment is payable to the vendor. Costs determined to be variable and not based on an index or rate are not included in the measurement of the lease liability and are recognized in the statements of comprehensive loss in the same line item as expenses arising from fixed lease payments at the time when the event giving rise to the payment occurs. Foreign currency translation The Company considers the U.S. dollar to be its functional currency. Expenses denominated in foreign currencies are translated at the exchange rate on the date the expense is incurred. The effect of exchange rate fluctuations on translating foreign currency assets and liabilities into U.S. dollars is included in the Statements of Comprehensive Loss. Foreign exchange transaction gains and losses are included in the results of operations and are not material in the Company’s financial statements. Research and development expenses Research and development expenses primarily consist of costs associated with the preclinical and clinical development of the Company’s product candidate portfolio, including the following: ● external research and development expenses incurred under arrangements with third parties, such as contract research organizations (“CROs”) and other vendors and contract manufacturing organizations (“CMOs”) for the production of drug substance and drug product; and ● employee-related expenses, including salaries, benefits and share-based compensation expense. Research and development expenses also include costs of acquired product licenses and related technology rights where there is no alternative future use, costs of prototypes used in research and development, consultant fees and amounts paid to certain of our collaborative partners. All research and development expenses are charged to operations as incurred in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic (“ASC”) 730, Research and Development Accrued research and development expenses As part of the process of preparing our financial statements, the Company is required to estimate its accrued expenses. This process involves reviewing quotations and contracts, identifying services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual cost. The majority of the Company’s service providers invoice the Company monthly in arrears for services performed or when contractual milestones are met. The Company makes estimates of its accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to the Company at that time. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary. The significant estimates in the Company’s accrued research and development expenses are related to expenses incurred with respect to CROs, CMOs and other vendors in connection with research and development and manufacturing activities. The Company bases its expense related to CROs and CMOs on its estimates of the services received and efforts expended pursuant to quotations and contracts with such vendors that conduct research and development and manufacturing activities on the Company’s behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment of the applicable research and development or manufacturing expense. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from its estimate, the Company adjusts the accrual or prepaid expense accordingly. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the Company’s understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in us reporting amounts that are too high or too low in any particular period. There have been no material changes in estimates for the periods presented. Stock-based compensation expense The Company follows the provisions of ASC 718, Compensation—Stock Compensation Stock Options The Company estimates the fair value of stock options on the date of grant using the Black-Scholes option-pricing model. Due to the lack of trading history, the Company’s computation of stock-price volatility is based on the volatility rates of comparable publicly held companies over a period equal to the expected term of the options granted by the Company. The Company’s computation of expected term is determined using the “simplified” method, which is the midpoint between the vesting date and the end of the contractual term. The Company believes that it does not have sufficient reliable exercise data in order to justify the use of a method other than the “simplified” method of estimating the expected exercise term of employee stock option grants. The Company utilizes a dividend yield of zero based on the fact that the Company has never paid cash dividends to stockholders and has no current intentions to pay cash dividends. The risk-free interest rate is based on the zero-coupon United States Treasury yield at the date of grant for a term equivalent to the expected term of the option. Stock-based compensation expense is included in both research and development expenses and general and administrative expenses in the Statements of Comprehensive Loss. Collaboration revenue At the inception of a collaboration agreement, the Company first assesses whether the contractual agreement is within the scope of ASC 808, Collaborative Arrangements Revenue from Contracts with Customers In accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (1) identify the contracts with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when or as the Company satisfies a performance obligation. From time to time, the Company enters into licensing agreements that are within the scope of ASC 606, under which it may license rights to research, develop and commercialize its product candidates to third parties. The terms of these collaborative research and development agreements typically include non-refundable, upfront license fees; reimbursement for research and development activities; development, regulatory and commercial milestone payments; and royalties on net sales of commercialized products. The Company may also enter into development and manufacturing service agreements with its collaborators. For each arrangement, at contract inception, the Company identifies all performance obligations, which may include a license to intellectual property and know-how, research and development activities, transition activities and/or manufacturing services and determines if each performance obligation is distinct. In order to determine the transaction price, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company’s control that could result in a significant reversal of revenue. These estimates are re-assessed each reporting period as required. Once the estimated transaction price is established, amounts are allocated to the performance obligations that have been identified. The transaction price is generally allocated to each separate performance obligation on a relative standalone selling price basis, which requires the use of assumptions and judgement. Standalone selling prices used to perform the initial allocation are not updated after contract inception. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when or as the performance obligation is satisfied. Amounts received prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current portion of deferred revenue in the accompanying balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. Refer to Note 6 – Commitments and Contingencies, for specific details regarding the Company’s collaboration agreements. Since the Company’s inception and through June 30, 2021, no revenue has been recognized by the Company. Income taxes The Company utilizes the liability method of accounting for deferred income taxes, as set forth in ASC 740, Income Taxes. Recent accounting pronouncements The Company considers the applicability and impact of all Accounting Standards Updates (“ASUs”). ASUs not discussed below were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) In August 2018, the FASB issued ASU No. 2018-15, Intangibles - Goodwill and Other - Internal-Use Software Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808) In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt - Modifications and Extinguishments (Subtopic 470-50), Compensation - Stock Compensation (Topic 718), and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (ASU 2021-04) |
CAPITALIZATION
CAPITALIZATION | 6 Months Ended |
Jun. 30, 2021 | |
Capitalization | |
CAPITALIZATION | 4. CAPITALIZATION On May 12, 2021, the Company held its Annual Meeting of Stockholders, at which the Company’s stockholders approved an amendment to the Company’s Second Amended and Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 100,000,000 150,000,000 As of June 30, 2021, the Company had authorized 150,000,000 0.0001 63,374,738 100,000,000 0.0001 56,517,891 In addition, as of June 30, 2021 and December 31, 2020, the Company had authorized 25,000,000 0.0001 |
CASH, CASH EQUIVALENTS, AND MAR
CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES | 6 Months Ended |
Jun. 30, 2021 | |
Cash and Cash Equivalents [Abstract] | |
CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES | 5. CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES The Company considers all highly liquid investments purchased with original maturities of 90 days or less at the date of purchase to be cash equivalents. Cash and cash equivalents as of June 30, 2021 and December 31, 2020 were $ 151.8 102.3 The Company considers securities with original maturities of greater than 90 days at the date of purchase to be available for sale securities. The Company held available for sale securities with a fair value totaling $ 24.6 19.5 The Company evaluates securities with unrealized losses, if any, to determine whether the decline in fair value has resulted from credit loss or other factors. As of June 30, 2021, the Company has not recognized any impairment or credit losses on the Company’s available for sale securities. While the Company classifies these securities as available for sale, the Company does not currently intend to sell its investments and the Company currently believes it has the ability to hold these investments until maturity. The following table summarizes the amortized cost, fair value and allowance for credit losses of the Company’s available for sale securities: SCHEDULE OF AVAILABLE FOR SALE SECURITIES June 30, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Corporate debt securities $ 24,585 $ 12 $ — $ 24,597 Total $ 24,585 $ 12 $ — $ 24,597 December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Corporate debt securities $ 19,545 $ — $ (15 ) $ 19,530 Total $ 19,545 $ — $ (15 ) $ 19,530 The Company’s available for sale securities are reported at fair value on the Company’s balance sheets. Unrealized gains (losses) are reported within accumulated other comprehensive income (loss) in the Statements of Comprehensive Loss. The cost of securities sold and any realized gains/losses from the sale of available for sale securities are based on the specific identification method. The changes in accumulated other comprehensive income (loss) associated with the unrealized gain (loss) on available for sale securities during the three and six months ended June 30, 2021 and 2020, respectively, were as follows: SCHEDULE OF ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) 2021 2020 2021 2020 Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Beginning balance $ (16 ) $ 210 $ (15 ) $ — Current period changes in fair value before reclassifications, net of tax 28 (112 ) 27 98 Amounts reclassified from accumulated other comprehensive income (loss), net of tax — — — — Other comprehensive income (loss) 28 (112 ) 27 98 Ending balance $ 12 $ 98 $ 12 $ 98 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 6. COMMITMENTS AND CONTINGENCIES License and Other Agreements In May 2018, the Company entered into an Asset Purchase Agreement (the “MacroGenics Asset Purchase Agreement”) with MacroGenics, Inc. (“MacroGenics”) pursuant to which the Company acquired MacroGenics’ interest in teplizumab (renamed PRV-031), a humanized mAb for the treatment of Type 1 Diabetes (“T1D”). As partial consideration for the MacroGenics Asset Purchase Agreement, the Company granted MacroGenics a warrant to purchase 2,162,389 2.50 170.0 60.0 225.0 0.7 In May 2018, the Company entered into a License Agreement with MacroGenics (the “MacroGenics License Agreement”), pursuant to which MacroGenics granted the Company exclusive global rights for the purpose of developing and commercializing MGD010 (renamed PRV-3279), a humanized protein and a potential treatment for systemic lupus erythematosus (“SLE”) and other similar diseases. As partial consideration for the MacroGenics License Agreement, the Company granted MacroGenics a warrant to purchase 270,299 2.50 42.5 22.5 225.0 1.1 The Company is obligated to use commercially reasonable efforts to develop and seek regulatory approval for PRV-3279. The license agreement may be terminated by either party upon a material breach or bankruptcy of the other party, by the Company without cause upon prior notice to MacroGenics, and by MacroGenics in the event that the Company challenges the validity of any licensed patent under the agreement. As of June 30, 2021, the Company has not achieved any milestones that would trigger payments to MacroGenics. In July 2019, MacroGenics elected to exercise its warrants for an aggregate of 2,432,688 1,948,474 In February 2021, the Company entered into a License Agreement with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (the “Huadong License Agreement”), pursuant to which the Company granted Huadong exclusive rights for the purpose of developing and commercializing PRV-3279, a DART® (bispecific antibody-based molecule) targeting the B cell surface proteins CD32B and CD79B, in Greater China (mainland China, Hong Kong, Macau and Taiwan). Provention Bio will retain exclusive worldwide rights to develop PRV-3279 for combination uses to reduce the immunogenicity of biotherapeutics, but Huadong will have the exclusive right to distribute PRV-3279 in that field in Greater China. In consideration of the license and other rights granted as part of the Huadong License Agreement, the Company received an upfront payment of $ 6.0 million and will receive up to $ 11.5 million in research, development and manufacturing funding over the next three years, of which $ 1.0 million was received as of June 30, 2021. If Huadong successfully develops, obtains regulatory approval for, and commercializes PRV-3279 in Greater China, the Company is eligible to receive up to $ 37.0 million in regulatory milestones and up to $ 135.0 million in commercial milestones based on aggregate net sales in a calendar year in Greater China. If commercialized, the Company would also be eligible to receive low double-digit royalties on net sales of PRV-3279 by Huadong in Greater China. The License Agreement may be terminated by either party upon a material breach or bankruptcy of the other party, by Huadong without cause upon at least 12 months prior notice to the Company and by the Company in the event Huadong challenges a licensed patent or in the event that the Company’s upstream license terminates. The Company may also terminate the License Agreement if Huadong ceases commercialization of PRV-3279 for a consecutive period of six months after first commercial sale. The Company is generally responsible for the manufacturing of PRV-3279 at least through regulatory approval in Greater China and Huadong will exclusively purchase all clinical and commercial supply requirements of PRV-3279 from the Company until Huadong exercises its option to assume manufacturing responsibilities, which may be triggered after regulatory approval in China. The Company will retain all rights to PRV-3279 in the rest of the world. The Company plans to begin a Phase 2a trial of PRV-3279 in systemic lupus erythematosus in the fourth quarter of 2021 and expects a portion of such trial to be conducted in Hong Kong. The Company evaluated the Huadong License Agreement under the provisions of ASC 606 and identified the following three material promises: (1) the license of rights to PRV-3279 in Greater China, (2) the performance of clinical research activities and (3) manufacturing process improvements. The Company concluded that the performance obligations were not distinct and consequently do not have value on a standalone basis. Accordingly, they were determined to represent one performance obligation. The Company determined that the transaction price of the Huadong License Agreement was $ 15.5 6.0 9.5 The Company determined to recognize revenue using a cost-based input method according to costs incurred to date compared to estimated total costs of the clinical research activities over the period which the activities are performed under the agreement, which is currently expected to occur from mid-2021 through mid-2024. The Company recognized no 7.0 In November 2018, the Company entered into a License and Collaboration Agreement (the “Amgen Agreement”) with Amgen, Inc. (“Amgen”) for PRV-015 (formerly AMG 714), a novel anti-IL-15 monoclonal antibody being developed for the treatment of gluten-free diet non-responsive celiac disease (“NRCD”). Under the terms of the agreement, the Company will conduct and fund a Phase 2b trial in NRCD and lead the development and regulatory activities for the program. Amgen agreed to make an equity investment of up to $ 20.0 150.0 70.0 2,500,000 8.00 20.0 In April 2017, the Company entered into a License Agreement with Vactech Ltd. (the “Vactech License Agreement”), pursuant to which Vactech Ltd. (“Vactech”) granted the Company exclusive global rights for the purpose of developing and commercializing the group B coxsackievirus vaccine (“CVB”) platform technology. In consideration of the licenses and other rights granted by Vactech, the Company issued two million shares of its common stock to Vactech. The Company recorded the issuance of the shares at their estimated fair value of approximately $ 1.70 3.4 0.5 24.5 of which the Company paid $ 0.5 19.0 Legal Proceedings On May 21, 2021, a putative class action complaint was filed in the U.S. District Court for the District of New Jersey (the “Court”), naming the Company, Chief Executive Officer Ashleigh Palmer, and Chief Financial Officer Andrew Drechsler as defendants. The complaint alleges violations of the Securities Exchange Act of 1934 and Rule 10b-5 in connection with disclosures made regarding the teplizumab BLA and teplizumab’s commercialization timeline. The plaintiff seeks to represent a class of shareholders who purchased or otherwise acquired the Company’s securities between November 2, 2020 and April 8, 2021. The complaint seeks unspecified damages. Per the procedures set forth by federal securities laws, applications for appointment of lead plaintiff(s) and lead counsel were due to the Court on July 20, 2021. Two applications for lead plaintiff and lead counsel were submitted to the Court on that date; one of the two movants subsequently withdrew its application. The Company is unable at this time to determine whether the outcome of the litigation would have a material impact on its results of operations, financial condition or cash flows. The Company does not have contingency reserves established for any litigation liabilities. |
NET LOSS PER SHARE OF COMMON ST
NET LOSS PER SHARE OF COMMON STOCK | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
NET LOSS PER SHARE OF COMMON STOCK | 7. NET LOSS PER SHARE OF COMMON STOCK Basic and diluted net loss per common share is determined by dividing net loss by the weighted average common shares outstanding during the period. For the periods where there is a net loss, stock options and warrants have been excluded from the calculation of diluted net loss per common share because their effect would be anti-dilutive. Therefore, the weighted average common shares used to calculate both basic and diluted net loss per common share would be the same. The following table sets forth the computation of basic and diluted net loss per share of common stock for the periods indicated: SCHEDULE OF COMPUTATION OF BASIC AND DILUTED NET LOSS PER SHARE Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Net loss $ (29,142 ) $ (22,122 ) $ (61,582 ) $ (34,704 ) Weighted average shares of common stock outstanding - basic and diluted 63,375 49,199 62,822 48,449 Net loss per share of common stock, basic and diluted $ (0.46 ) $ (0.45 ) $ (0.98 ) $ (0.72 ) The following potentially dilutive securities have been excluded from the computation of diluted weighted average shares outstanding as they would be antidilutive: SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Stock options 12,103 6,846 12,103 6,846 Warrants 1,705 1,972 1,705 1,972 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 6 Months Ended |
Jun. 30, 2021 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | 8. ACCRUED EXPENSES Accrued expenses consisted of the following: SCHEDULE OF ACCRUED EXPENSES June 30, 2021 December 31, 2020 Accrued research and development costs $ 8,620 $ 5,165 Accrued compensation 2,364 1,443 Accrued pre-commercial costs 1,336 1,191 Accrued professional fees 1,160 1,197 Other accrued liabilities 287 166 Total accrued expenses $ 13,767 $ 9,162 |
FAIR VALUE OF ASSETS AND LIABIL
FAIR VALUE OF ASSETS AND LIABILITIES | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE OF ASSETS AND LIABILITIES | 9. FAIR VALUE OF ASSETS AND LIABILITIES The carrying amounts reported in the balance sheet for cash and cash equivalents, accounts payable and accrued expenses approximate fair value based on the short-term nature of these items. In accordance with accounting principles generally accepted in the United States, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. A three-level hierarchy prioritizes the inputs used to measure fair value as follows: Level 1 – Valuation is based on quoted prices in active markets for identical assets or liabilities. Level 1 assets and liabilities generally include debt and equity securities that are traded in an active exchange market. Valuations are obtained from readily available pricing sources for market transactions involving identical assets or liabilities. Level 2 – Valuation is based on observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 – Valuation is based on unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Level 3 assets and liabilities include financial instruments whose value is determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant management judgment or estimation. The following is a summary of assets and their related classifications under the fair value hierarchy: SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE ON RECURRING BASIS June 30, 2021 Financial Instruments Carried at Fair Value Quoted prices in active markets for identical items (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Total Assets: Cash and cash equivalents 1 $ 151,781 $ — $ — $ 151,781 Investments in Corporate debt securities 2 — 24,597 — 24,597 December 31, 2020 Financial Instruments Carried at Fair Value Quoted prices in active markets for Significant other Significant identical items observable inputs unobservable inputs (Level 1) (Level 2) (Level 3) Total Assets: Cash and cash equivalents 1 $ 102,294 $ — $ — $ 102,294 Investments in Corporate debt securities 2 — 19,530 — 19,530 1 Cash and cash equivalents primarily include investments in money market funds 2 Investments in investment-grade corporate debt securities are classified as available for sale securities |
STOCK OPTIONS
STOCK OPTIONS | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
STOCK OPTIONS | 10. STOCK OPTIONS In 2017, the Company adopted the Provention Bio, Inc. 2017 Equity Incentive Plan (the “2017 Plan”). Pursuant to the 2017 Plan, the Company’s Board of Directors may grant incentive stock options, nonqualified stock options, and restricted stock to employees, officers, directors, consultants and advisors. As of June 30, 2021, there were options to purchase an aggregate of 11,665,932 10 In 2018, the Company amended and restated its 2017 Plan to, among other things, include an evergreen provision, which would automatically increase the number of shares available for issuance under the 2017 Plan in an amount equal to (1) the difference between (x) 18% of the total shares of the Company’s common stock outstanding, on a fully diluted basis, on December 31st of the preceding calendar year, and (y) the total number of shares of the Company’s common stock reserved under the 2017 Plan on December 31st of such preceding calendar year or (2) an amount less than this calculated increase as determined by the board of directors. In connection with the evergreen provisions of the 2017 Plan, the number of shares available for issuance under the 2017 Plan was increased by 2,270,353 197,801 In October 2020, the Company adopted the Provention Bio, Inc. 2020 Inducement Plan (the “2020 Inducement Plan”). Pursuant to the terms of the 2020 Inducement Plan, the Company may grant non-statutory stock options, stock appreciation rights, restricted stock unit awards and restricted stock for up to a total of 2,000,000 436,800 1,563,200 Options issued under the 2020 Inducement Plan are exercisable for up to 10 Stock-based compensation Total stock-based compensation expense recognized for both employees and non-employees was as follows: SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 General and administrative $ 2,069 $ 848 $ 3,875 $ 1,561 Research and development 1,198 429 2,249 952 Total stock-based compensation expense $ 3,267 $ 1,277 $ 6,124 $ 2,513 Option activity The Company grants options with service-based vesting requirements as well as options with performance-based vesting requirements. Generally, the service-based requirements vest over a four-year period in multiple tranches. Each tranche of the performance-based component vests upon the achievement of a specific milestone. These milestones are related to the Company’s clinical trials, manufacturing activities, regulatory activities, commercial activities and certain other performance metrics. A summary of option activity for the six months ended June 30, 2021 are presented below: SUMMARY OF STOCK OPTION ACTIVITY Weighted- Weighted- Average Average Remaining Underlying Exercise Contractual Intrinsic Stock Option Awards Shares Price Term Value Outstanding at December 31, 2020 9,503 $ 9.10 8.3 $ — Granted 2,922 $ 7.70 Exercised (19 ) $ 2.50 Forfeited or expired (303 ) $ 5.26 Outstanding at June 30, 2021 12,103 $ 8.87 8.3 $ 22,258 Exercisable at June 30, 2021 4,367 $ 6.26 7.0 $ 15,851 The weighted average grant-date fair value of options granted during the six months ended June 30, 2021, was $ 5.34 2,240,000 14.7 5,496,000 32.4 3.1 Cash proceeds from, and the aggregate intrinsic value of, stock options exercised during the periods presented below were as follows: SCHEDULE OF AGGREGATED INTRINSIC VALUE OF STOCK OPTION EXERCISED 2021 2020 2021 2020 Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Cash proceeds from options exercised $ — $ 380 $ 48 $ 574 Aggregate intrinsic value of options exercised — 323 239 953 The Company uses the Black-Scholes option-pricing model to estimate the fair value of option awards with the following weighted-average assumptions for the period indicated: SCHEDULE OF SHARE-BASED COMPENSATION VALUATION OF ASSUMPTIONS Six Months Ended June 30, 2021 2020 Exercise price $ 7.70 $ 13.09 Expected volatility 81 % 73 % Expected dividends — — Expected term (in years) 6.1 6.2 Risk-free interest rate 1.07 % 1.05 % The weighted-average valuation assumptions were determined as follows: ● Risk-free interest rate: The Company bases the risk-free interest rate on the interest rate payable on United States Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected option term. ● Expected annual dividends: The estimate for annual dividends is 0 ● Expected stock price volatility: The expected volatility used is based on historical volatilities of similar entities within the Company’s industry which were commensurate with the Company’s expected term assumption. ● Expected term of options: The expected term of options represents the period of time options are expected to be outstanding. The expected term of the options granted to employees is derived from the “simplified” method as described in Staff Accounting Bulletin 107 relating to stock-based compensation, whereby the expected term is an average between the vesting period and contractual period due to the limited operating history. |
WARRANTS
WARRANTS | 6 Months Ended |
Jun. 30, 2021 | |
Warrants and Rights Note Disclosure [Abstract] | |
WARRANTS | 11. WARRANTS In connection with the April 2017 sale of Series A Convertible Redeemable Preferred Stock, the Company issued warrants to MDB, the placement agent, and its designees to purchase 558,740 2.50 seven 558,740 In June 2020, certain warrant holders from the Series A offering elected to exercise warrants for an aggregate of 153,000 129,719 316,754 241,986 In connection with the Company’s completion of its IPO, in July 2018, the Company issued to MDB, the underwriter in the IPO, and its designees warrants to purchase 1,596,956 5.00 five 134,114 1,462,842 |
FIXED ASSETS
FIXED ASSETS | 6 Months Ended |
Jun. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
FIXED ASSETS | 12. FIXED ASSETS Fixed assets consisted of the following: SCHEDULE OF FIXED ASSETS June 30, 2021 December 31, 2020 Leasehold improvements $ 838 $ 828 Software 287 — Furniture and fixtures 149 149 Office equipment 35 35 Clinical equipment 60 27 Construction in progress 1,026 431 2,395 1,470 Less accumulated depreciation (187 ) (33 ) Fixed assets, net $ 2,208 $ 1,437 Depreciation expense was $ 0.1 0.2 no |
LEASES
LEASES | 6 Months Ended |
Jun. 30, 2021 | |
Lessee Disclosure [Abstract] | |
LEASES | 13. LEASES The Company’s lease portfolio consists of one office lease located in Red Bank, NJ. This lease is classified as an operating lease and has an initial term of 64 months from the lease commencement date, which began in October 2020. The components of lease costs from continuing operations were as follows: SCHEDULE OF LEASE COSTS 2021 2020 2021 2020 Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Operating lease costs $ 37 $ — $ 74 $ — Variable lease costs 6 — 12 — Total lease costs $ 43 $ — $ 86 $ — Supplemental balance sheet information related to leases are as follows: SCHEDULE OF SUPPLEMENTAL BALANCE SHEET INFORMATION Classification As of June 30, 2021 As of December 31, 2020 Operating leases Lease right-of-use assets Non-current Operating lease right-of-use assets $ 393 $ 408 Lease liabilities Current Accrued expenses $ 114 $ 72 Non-current Operating lease liabilities, long-term $ 655 $ 715 Weighted average remaining lease term Operating leases 4.7 5.2 Weighted average discount rate Operating leases 15.0 % 15.0 % As of June 30, 2021, maturities of lease liabilities on an annual basis for the remaining years of the Company’s non-cancelable lease agreements were as follows: SCHEDULE OF MATURITIES OF LEASE LIABILITIES Operating Leases Year ending December 31, 2021 (remaining) $ 108 2022 221 2023 227 2024 232 2025 238 Thereafter 41 Total lease payments 1,067 Less: present value discount 298 Present value of lease liabilities $ 769 |
INCOME TAXES
INCOME TAXES | 6 Months Ended |
Jun. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | 14. INCOME TAXES The Company recorded a benefit from state income taxes of approximately $ 1.0 million and $ 0.5 11.9 million and $ 6.8 1.0 million and $ 0.5 |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Use of estimates | Use of estimates The process of preparing financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of assets and liabilities at the date of financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates and changes in estimates may occur. |
Segment and geographic information | Segment and geographic information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one |
Cash, cash equivalents and concentration of credit risk | Cash, cash equivalents and concentration of credit risk The Company considers only those investments which are highly liquid, readily convertible to cash, or that mature within 90 days from the date of purchase to be cash equivalents. Marketable securities are those investments with original maturities in excess of 90 days. The carrying amounts reported in the balance sheets for cash and cash equivalents are valued at cost, which approximates their fair value. The Company has no off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements. The Company holds cash and cash equivalents in banks in excess of FDIC insurance limits. However, the Company believes risk of loss is minimal as the cash and cash equivalents are held by large, highly-rated financial institutions. |
Marketable securities | Marketable securities The Company considers securities with original maturities of greater than 90 days to be available for sale securities. Available for sale securities are classified as either current or non-current assets based on the nature of the securities and their availability for use in current operations. Available for sale securities are recorded at fair value and unrealized gains and losses are recorded within accumulated other comprehensive income. The estimated fair value of the available for sale securities is determined based on quoted market prices or rates for similar instruments. In addition, the cost of debt securities in this category is adjusted for amortization of premium and accretion of discount to maturity. On a quarterly basis, the Company reviews the status of each security in an unrealized loss position, to evaluate the existence of potential credit losses. The Company first considers whether it intends to sell, or if it is more likely than not that the Company will be required to sell the security before recovery of its amortized cost basis. If either of the criteria regarding intent or requirement to sell is met, the security’s amortized cost basis is written down to fair value through income. For securities that do not meet this criteria, the Company considers a number of factors to determine if the decline in fair value has resulted from credit losses or other factors, including but not limited to: (1) the extent of the decline; (2) changes to the rating of the security by a rating agency; (3) any adverse conditions specific to the security; and (4) other market conditions that may affect the fair value of the security. If this assessment indicates that a credit loss exists and the present value of cash flows expected to be collected is less than the amortized cost basis, an allowance for credit losses is required for the credit loss. Any impairment that has not been recorded through an allowance for credit losses is recognized in other comprehensive income. As of June 30, 2021, the Company has not recognized any impairment or credit losses on its available for sale securities. |
Financial instruments | Financial instruments Cash, cash equivalents and marketable securities are reflected in the accompanying financial statements at fair value. The carrying amount of accounts payable and accrued expenses, including accrued research and development expenses, approximates fair value due to the short-term nature of those instruments. |
Fixed assets, net | Fixed assets, net Fixed assets, which consists primarily of leasehold improvements, furniture and fixtures, software, office equipment and certain clinical equipment, are carried at cost less accumulated depreciation. Depreciation is computed over the estimated useful lives of the respective assets, generally three seven |
Leases | Leases The Company determines if an arrangement is a lease at contract inception. A lease is a contract, or part of a contract, that conveys the right to control the use of explicitly or implicitly identified property, plant or equipment in exchange for consideration. Control of an underlying asset is conveyed to the Company if the Company obtains the rights to direct the use of and to obtain substantially all of the economic benefits from using the underlying asset. The Company classifies its leases as operating or financing by considering factors such as the length of the lease term, the present value of the lease payments, the specialized nature of the asset being leased and the potential for ownership of the asset to transfer during the lease term. Leases with terms greater than one-year are recognized on the Company’s balance sheets as right-of-use (“ROU”) assets and lease liabilities and are measured at the present value of the fixed payments due over the lease term minus the present value of any incentives, rebates or abatements expected to be received from the lessor. Options to extend a lease are typically excluded from the expected lease term as the exercise of the option is typically not reasonably certain. Leases are measured at present value using the rate implicit in the lease or, if the implicit rate is not determinable, the lessee’s incremental borrowing rate. As the implicit rate is not typically readily determinable, the Company uses an incremental borrowing rate, which is established based upon the information available at the lease commencement date, to determine the present value of lease payments due under an arrangement. The incremental borrowing rate approximates the rate the Company would pay to borrow on a collateralized basis over a similar term and amount equal to the lease payments. ROU assets are amortized on a straight-line basis over the term of the lease. Lease liabilities accrete to yield and are reduced at the time when the lease payment is payable to the vendor. Costs determined to be variable and not based on an index or rate are not included in the measurement of the lease liability and are recognized in the statements of comprehensive loss in the same line item as expenses arising from fixed lease payments at the time when the event giving rise to the payment occurs. |
Foreign currency translation | Foreign currency translation The Company considers the U.S. dollar to be its functional currency. Expenses denominated in foreign currencies are translated at the exchange rate on the date the expense is incurred. The effect of exchange rate fluctuations on translating foreign currency assets and liabilities into U.S. dollars is included in the Statements of Comprehensive Loss. Foreign exchange transaction gains and losses are included in the results of operations and are not material in the Company’s financial statements. |
Research and development expenses | Research and development expenses Research and development expenses primarily consist of costs associated with the preclinical and clinical development of the Company’s product candidate portfolio, including the following: ● external research and development expenses incurred under arrangements with third parties, such as contract research organizations (“CROs”) and other vendors and contract manufacturing organizations (“CMOs”) for the production of drug substance and drug product; and ● employee-related expenses, including salaries, benefits and share-based compensation expense. Research and development expenses also include costs of acquired product licenses and related technology rights where there is no alternative future use, costs of prototypes used in research and development, consultant fees and amounts paid to certain of our collaborative partners. All research and development expenses are charged to operations as incurred in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic (“ASC”) 730, Research and Development |
Accrued research and development expenses | Accrued research and development expenses As part of the process of preparing our financial statements, the Company is required to estimate its accrued expenses. This process involves reviewing quotations and contracts, identifying services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual cost. The majority of the Company’s service providers invoice the Company monthly in arrears for services performed or when contractual milestones are met. The Company makes estimates of its accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to the Company at that time. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary. The significant estimates in the Company’s accrued research and development expenses are related to expenses incurred with respect to CROs, CMOs and other vendors in connection with research and development and manufacturing activities. The Company bases its expense related to CROs and CMOs on its estimates of the services received and efforts expended pursuant to quotations and contracts with such vendors that conduct research and development and manufacturing activities on the Company’s behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment of the applicable research and development or manufacturing expense. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from its estimate, the Company adjusts the accrual or prepaid expense accordingly. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the Company’s understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in us reporting amounts that are too high or too low in any particular period. There have been no material changes in estimates for the periods presented. |
Stock-based compensation expense | Stock-based compensation expense The Company follows the provisions of ASC 718, Compensation—Stock Compensation Stock Options The Company estimates the fair value of stock options on the date of grant using the Black-Scholes option-pricing model. Due to the lack of trading history, the Company’s computation of stock-price volatility is based on the volatility rates of comparable publicly held companies over a period equal to the expected term of the options granted by the Company. The Company’s computation of expected term is determined using the “simplified” method, which is the midpoint between the vesting date and the end of the contractual term. The Company believes that it does not have sufficient reliable exercise data in order to justify the use of a method other than the “simplified” method of estimating the expected exercise term of employee stock option grants. The Company utilizes a dividend yield of zero based on the fact that the Company has never paid cash dividends to stockholders and has no current intentions to pay cash dividends. The risk-free interest rate is based on the zero-coupon United States Treasury yield at the date of grant for a term equivalent to the expected term of the option. Stock-based compensation expense is included in both research and development expenses and general and administrative expenses in the Statements of Comprehensive Loss. |
Collaboration revenue | Collaboration revenue At the inception of a collaboration agreement, the Company first assesses whether the contractual agreement is within the scope of ASC 808, Collaborative Arrangements Revenue from Contracts with Customers In accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (1) identify the contracts with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when or as the Company satisfies a performance obligation. From time to time, the Company enters into licensing agreements that are within the scope of ASC 606, under which it may license rights to research, develop and commercialize its product candidates to third parties. The terms of these collaborative research and development agreements typically include non-refundable, upfront license fees; reimbursement for research and development activities; development, regulatory and commercial milestone payments; and royalties on net sales of commercialized products. The Company may also enter into development and manufacturing service agreements with its collaborators. For each arrangement, at contract inception, the Company identifies all performance obligations, which may include a license to intellectual property and know-how, research and development activities, transition activities and/or manufacturing services and determines if each performance obligation is distinct. In order to determine the transaction price, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company’s control that could result in a significant reversal of revenue. These estimates are re-assessed each reporting period as required. Once the estimated transaction price is established, amounts are allocated to the performance obligations that have been identified. The transaction price is generally allocated to each separate performance obligation on a relative standalone selling price basis, which requires the use of assumptions and judgement. Standalone selling prices used to perform the initial allocation are not updated after contract inception. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when or as the performance obligation is satisfied. Amounts received prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current portion of deferred revenue in the accompanying balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. Refer to Note 6 – Commitments and Contingencies, for specific details regarding the Company’s collaboration agreements. Since the Company’s inception and through June 30, 2021, no revenue has been recognized by the Company. |
Income taxes | Income taxes The Company utilizes the liability method of accounting for deferred income taxes, as set forth in ASC 740, Income Taxes. |
Recent accounting pronouncements | Recent accounting pronouncements The Company considers the applicability and impact of all Accounting Standards Updates (“ASUs”). ASUs not discussed below were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) In August 2018, the FASB issued ASU No. 2018-15, Intangibles - Goodwill and Other - Internal-Use Software Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808) In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt - Modifications and Extinguishments (Subtopic 470-50), Compensation - Stock Compensation (Topic 718), and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (ASU 2021-04) |
CASH, CASH EQUIVALENTS, AND M_2
CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Cash and Cash Equivalents [Abstract] | |
SCHEDULE OF AVAILABLE FOR SALE SECURITIES | The following table summarizes the amortized cost, fair value and allowance for credit losses of the Company’s available for sale securities: SCHEDULE OF AVAILABLE FOR SALE SECURITIES June 30, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Corporate debt securities $ 24,585 $ 12 $ — $ 24,597 Total $ 24,585 $ 12 $ — $ 24,597 December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Corporate debt securities $ 19,545 $ — $ (15 ) $ 19,530 Total $ 19,545 $ — $ (15 ) $ 19,530 |
SCHEDULE OF ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) | SCHEDULE OF ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) 2021 2020 2021 2020 Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Beginning balance $ (16 ) $ 210 $ (15 ) $ — Current period changes in fair value before reclassifications, net of tax 28 (112 ) 27 98 Amounts reclassified from accumulated other comprehensive income (loss), net of tax — — — — Other comprehensive income (loss) 28 (112 ) 27 98 Ending balance $ 12 $ 98 $ 12 $ 98 |
NET LOSS PER SHARE OF COMMON _2
NET LOSS PER SHARE OF COMMON STOCK (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
SCHEDULE OF COMPUTATION OF BASIC AND DILUTED NET LOSS PER SHARE | The following table sets forth the computation of basic and diluted net loss per share of common stock for the periods indicated: SCHEDULE OF COMPUTATION OF BASIC AND DILUTED NET LOSS PER SHARE Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Net loss $ (29,142 ) $ (22,122 ) $ (61,582 ) $ (34,704 ) Weighted average shares of common stock outstanding - basic and diluted 63,375 49,199 62,822 48,449 Net loss per share of common stock, basic and diluted $ (0.46 ) $ (0.45 ) $ (0.98 ) $ (0.72 ) |
SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE | The following potentially dilutive securities have been excluded from the computation of diluted weighted average shares outstanding as they would be antidilutive: SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Stock options 12,103 6,846 12,103 6,846 Warrants 1,705 1,972 1,705 1,972 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCRUED EXPENSES | Accrued expenses consisted of the following: SCHEDULE OF ACCRUED EXPENSES June 30, 2021 December 31, 2020 Accrued research and development costs $ 8,620 $ 5,165 Accrued compensation 2,364 1,443 Accrued pre-commercial costs 1,336 1,191 Accrued professional fees 1,160 1,197 Other accrued liabilities 287 166 Total accrued expenses $ 13,767 $ 9,162 |
FAIR VALUE OF ASSETS AND LIAB_2
FAIR VALUE OF ASSETS AND LIABILITIES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE ON RECURRING BASIS | The following is a summary of assets and their related classifications under the fair value hierarchy: SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE ON RECURRING BASIS June 30, 2021 Financial Instruments Carried at Fair Value Quoted prices in active markets for identical items (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Total Assets: Cash and cash equivalents 1 $ 151,781 $ — $ — $ 151,781 Investments in Corporate debt securities 2 — 24,597 — 24,597 December 31, 2020 Financial Instruments Carried at Fair Value Quoted prices in active markets for Significant other Significant identical items observable inputs unobservable inputs (Level 1) (Level 2) (Level 3) Total Assets: Cash and cash equivalents 1 $ 102,294 $ — $ — $ 102,294 Investments in Corporate debt securities 2 — 19,530 — 19,530 1 Cash and cash equivalents primarily include investments in money market funds 2 Investments in investment-grade corporate debt securities are classified as available for sale securities |
STOCK OPTIONS (Tables)
STOCK OPTIONS (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE | Total stock-based compensation expense recognized for both employees and non-employees was as follows: SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 General and administrative $ 2,069 $ 848 $ 3,875 $ 1,561 Research and development 1,198 429 2,249 952 Total stock-based compensation expense $ 3,267 $ 1,277 $ 6,124 $ 2,513 |
SUMMARY OF STOCK OPTION ACTIVITY | A summary of option activity for the six months ended June 30, 2021 are presented below: SUMMARY OF STOCK OPTION ACTIVITY Weighted- Weighted- Average Average Remaining Underlying Exercise Contractual Intrinsic Stock Option Awards Shares Price Term Value Outstanding at December 31, 2020 9,503 $ 9.10 8.3 $ — Granted 2,922 $ 7.70 Exercised (19 ) $ 2.50 Forfeited or expired (303 ) $ 5.26 Outstanding at June 30, 2021 12,103 $ 8.87 8.3 $ 22,258 Exercisable at June 30, 2021 4,367 $ 6.26 7.0 $ 15,851 |
SCHEDULE OF AGGREGATED INTRINSIC VALUE OF STOCK OPTION EXERCISED | Cash proceeds from, and the aggregate intrinsic value of, stock options exercised during the periods presented below were as follows: SCHEDULE OF AGGREGATED INTRINSIC VALUE OF STOCK OPTION EXERCISED 2021 2020 2021 2020 Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Cash proceeds from options exercised $ — $ 380 $ 48 $ 574 Aggregate intrinsic value of options exercised — 323 239 953 |
SCHEDULE OF SHARE-BASED COMPENSATION VALUATION OF ASSUMPTIONS | The Company uses the Black-Scholes option-pricing model to estimate the fair value of option awards with the following weighted-average assumptions for the period indicated: SCHEDULE OF SHARE-BASED COMPENSATION VALUATION OF ASSUMPTIONS Six Months Ended June 30, 2021 2020 Exercise price $ 7.70 $ 13.09 Expected volatility 81 % 73 % Expected dividends — — Expected term (in years) 6.1 6.2 Risk-free interest rate 1.07 % 1.05 % |
FIXED ASSETS (Tables)
FIXED ASSETS (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
SCHEDULE OF FIXED ASSETS | Fixed assets consisted of the following: SCHEDULE OF FIXED ASSETS June 30, 2021 December 31, 2020 Leasehold improvements $ 838 $ 828 Software 287 — Furniture and fixtures 149 149 Office equipment 35 35 Clinical equipment 60 27 Construction in progress 1,026 431 2,395 1,470 Less accumulated depreciation (187 ) (33 ) Fixed assets, net $ 2,208 $ 1,437 |
LEASES (Tables)
LEASES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Lessee Disclosure [Abstract] | |
SCHEDULE OF LEASE COSTS | The components of lease costs from continuing operations were as follows: SCHEDULE OF LEASE COSTS 2021 2020 2021 2020 Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Operating lease costs $ 37 $ — $ 74 $ — Variable lease costs 6 — 12 — Total lease costs $ 43 $ — $ 86 $ — |
SCHEDULE OF SUPPLEMENTAL BALANCE SHEET INFORMATION | Supplemental balance sheet information related to leases are as follows: SCHEDULE OF SUPPLEMENTAL BALANCE SHEET INFORMATION Classification As of June 30, 2021 As of December 31, 2020 Operating leases Lease right-of-use assets Non-current Operating lease right-of-use assets $ 393 $ 408 Lease liabilities Current Accrued expenses $ 114 $ 72 Non-current Operating lease liabilities, long-term $ 655 $ 715 Weighted average remaining lease term Operating leases 4.7 5.2 Weighted average discount rate Operating leases 15.0 % 15.0 % |
SCHEDULE OF MATURITIES OF LEASE LIABILITIES | As of June 30, 2021, maturities of lease liabilities on an annual basis for the remaining years of the Company’s non-cancelable lease agreements were as follows: SCHEDULE OF MATURITIES OF LEASE LIABILITIES Operating Leases Year ending December 31, 2021 (remaining) $ 108 2022 221 2023 227 2024 232 2025 238 Thereafter 41 Total lease payments 1,067 Less: present value discount 298 Present value of lease liabilities $ 769 |
LIQUIDITY (Details Narrative)
LIQUIDITY (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | |||
Feb. 28, 2021 | Jan. 31, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Dec. 31, 2020 | |
Subsidiary, Sale of Stock [Line Items] | |||||
Retained Earnings (Accumulated Deficit) | $ 239,224 | $ 177,642 | |||
At The Market [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Sale of Stock, Number of Shares Issued in Transaction | 725,495 | ||||
Sale of Stock, Consideration Received on Transaction | $ 9,900 | ||||
Sales Commissions and Fees | $ 300 | ||||
At The Market [Member] | Maximum [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Sale of Stock, Consideration Received on Transaction | $ 150,000 | ||||
Underwriter's Option [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Sale of Stock, Number of Shares Issued in Transaction | 6,250,000 | ||||
Sale of Stock, Price Per Share | $ 16 | ||||
Stock Issued During Period, Shares, New Issues | 587,500 | ||||
Shares Issued, Price Per Share | $ 16 | ||||
Proceeds from Issuance or Sale of Equity | $ 102,300 | ||||
Underwriting discounts and commissions | 6,600 | ||||
Other offering expenses | $ 500 |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) | 6 Months Ended |
Jun. 30, 2021Segment | |
Property, Plant and Equipment [Line Items] | |
Number of operating segments | 1 |
Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Fixed assets estimated useful life years | three |
Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Fixed assets estimated useful life years | seven |
CAPITALIZATION (Details Narrati
CAPITALIZATION (Details Narrative) - $ / shares | Jun. 30, 2021 | May 12, 2021 | May 11, 2021 | Dec. 31, 2020 |
Capitalization | ||||
Common Stock, Shares Authorized | 150,000,000 | 150,000,000 | 100,000,000 | 100,000,000 |
Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 | ||
Common Stock, Shares, Outstanding | 63,374,738 | 56,517,891 | ||
Common Stock, Shares, Issued | 63,374,738 | 56,517,891 | ||
Preferred Stock, Shares Authorized | 25,000,000 | 25,000,000 | ||
Preferred Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 |
SCHEDULE OF AVAILABLE FOR SALE
SCHEDULE OF AVAILABLE FOR SALE SECURITIES (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Cash and Cash Equivalents [Line Items] | ||
Amortized Cost | $ 24,585 | $ 19,545 |
Gross Unrealized Gains | 12 | |
Gross Unrealized Losses | (15) | |
Fair Value | 24,597 | 19,530 |
Corporate Debt Securities [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Amortized Cost | 24,585 | 19,545 |
Gross Unrealized Gains | 12 | |
Gross Unrealized Losses | (15) | |
Fair Value | $ 24,597 | $ 19,530 |
SCHEDULE OF ACCUMULATED OTHER C
SCHEDULE OF ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Cash and Cash Equivalents [Abstract] | ||||
Beginning balance | $ (16) | $ 210 | $ (15) | |
Current period changes in fair value before reclassifications, net of tax | 28 | (112) | 27 | 98 |
Amounts reclassified from accumulated other comprehensive income (loss), net of tax | ||||
Other comprehensive income (loss) | 28 | (112) | 27 | 98 |
Ending balance | $ 12 | $ 98 | $ 12 | $ 98 |
CASH, CASH EQUIVALENTS, AND M_3
CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES (Details Narrative) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Cash and Cash Equivalents [Abstract] | ||
Cash and Cash Equivalents, at Carrying Value | $ 151,781 | $ 102,294 |
Available-for-sale Securities and Held-to-maturity Securities | $ 24,600 | $ 19,500 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) $ / shares in Units, $ in Millions | Feb. 25, 2021 | May 31, 2021 | Feb. 25, 2021 | Jan. 31, 2021 | Sep. 30, 2019 | Jul. 31, 2019 | Nov. 30, 2018 | May 31, 2018 | Apr. 30, 2017 | Jun. 30, 2021 | Jun. 30, 2021 |
Loss Contingencies [Line Items] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 316,754 | 316,754 | |||||||||
Collaboration revenue | $ 0 | $ 0 | |||||||||
Deferred revenue | $ 7 | 7 | |||||||||
Second Indication [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Amount payable by the entity on achievement of various milestones | $ 225 | ||||||||||
Macro Genics Inc [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,432,688 | ||||||||||
Number of warrants issuance shares | 1,948,474 | ||||||||||
Amgen Inc [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Amount payable by the entity on achievement of various milestones | $ 70 | ||||||||||
Amgen Inc [Member] | Private Placement [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Sale of Stock, Number of Shares Issued in Transaction | 2,500,000 | ||||||||||
Sale of Stock, Price Per Share | $ 8 | ||||||||||
Proceeds from Issuance of Private Placement | $ 20 | ||||||||||
Asset Purchase Agreement [Member] | Macro Genics Inc [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 2,162,389 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.50 | ||||||||||
Amount payable by the entity on achievement of various milestones | $ 170 | ||||||||||
Asset Purchase Agreement [Member] | Macro Genics Inc [Member] | Maximum [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Amount payable by the entity on achievement of various milestones | 0.7 | ||||||||||
Asset Purchase Agreement [Member] | Macro Genics Inc [Member] | Biologics License Application [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Amount payable by the entity on achievement of various milestones | $ 60 | ||||||||||
License Agreement [Member] | Macro Genics Inc [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 270,299 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.50 | ||||||||||
Amount payable by the entity on achievement of various milestones | $ 225 | ||||||||||
License Agreement [Member] | Macro Genics Inc [Member] | First Indication [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Amount payable by the entity on achievement of various milestones | 42.5 | ||||||||||
License Agreement [Member] | Macro Genics Inc [Member] | Second Indication [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Amount payable by the entity on achievement of various milestones | $ 22.5 | ||||||||||
License Agreement [Member] | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
License agreement amount paid | $ 1.1 | ||||||||||
License Agreement [Member] | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd [Member] | Research Development and Manufacturing Funding [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Upfront payment received | $ 6 | ||||||||||
Future research and development funding received | $ 1 | ||||||||||
License Agreement [Member] | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd [Member] | Maximum [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Future development and regulatory milestones receivable | $ 37 | 37 | |||||||||
Future commercial milestones receivable | 135 | 135 | |||||||||
License Agreement [Member] | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd [Member] | Maximum [Member] | Research Development and Manufacturing Funding [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Future research and development funding receivable | 11.5 | ||||||||||
License Agreement [Member] | Vactech [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Amount payable by the entity on achievement of various milestones | $ 24.5 | ||||||||||
Shares issued price per share | $ 1.70 | ||||||||||
Amount payable by the entity on achievement of various milestones | $ 19 | ||||||||||
License Agreement [Member] | Vactech [Member] | Research and Development Expense [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Warrants issued during period fair value | 3.4 | ||||||||||
License Agreement [Member] | Vactech [Member] | First Eighteen Months [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Payments made for development and manufacturing services | $ 0.5 | ||||||||||
License Agreement [Member] | Vactech [Member] | Dosing Of First Patient In Phase 1 PROVENT Study [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Amount paid by the entity on achievement of various milestones | $ 0.5 | ||||||||||
Huadong License Agreement [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Transaction price | 15.5 | 15.5 | |||||||||
Upfront Payment | 6 | ||||||||||
License agreement fund receivable | $ 9.5 | $ 9.5 | |||||||||
License and Collaboration Agreement [Member] | Amgen Inc [Member] | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Potential proceeds from investment by collaborator | 20 | ||||||||||
Amount payable by the entity on achievement of various milestones | $ 150 |
SCHEDULE OF COMPUTATION OF BASI
SCHEDULE OF COMPUTATION OF BASIC AND DILUTED NET LOSS PER SHARE (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Earnings Per Share [Abstract] | ||||
Net loss | $ (29,142) | $ (22,122) | $ (61,582) | $ (34,704) |
Weighted average shares of common stock outstanding - basic and diluted | 63,375 | 49,199 | 62,822 | 48,449 |
Net loss per share of common stock, basic and diluted | $ (0.46) | $ (0.45) | $ (0.98) | $ (0.72) |
SCHEDULE OF ANTIDILUTIVE SECURI
SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE (Details) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Stock Options [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share | 12,103 | 6,846 | 12,103 | 6,846 |
Warrants [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share | 1,705 | 1,972 | 1,705 | 1,972 |
SCHEDULE OF ACCRUED EXPENSES (D
SCHEDULE OF ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued research and development costs | $ 8,620 | $ 5,165 |
Accrued compensation | 2,364 | 1,443 |
Accrued pre-commercial costs | 1,336 | 1,191 |
Accrued professional fees | 1,160 | 1,197 |
Other accrued liabilities | 287 | 166 |
Total accrued expenses | $ 13,767 | $ 9,162 |
SCHEDULE OF ASSETS AND LIABILIT
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE ON RECURRING BASIS (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | |
Cash and Cash Equivalents [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of assets | [1] | $ 151,781 | $ 102,294 |
Investments In Corporate Debt Securities [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of assets | [2] | 24,597 | 19,530 |
Fair Value, Inputs, Level 1 [Member] | Cash and Cash Equivalents [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of assets | [1] | 151,781 | 102,294 |
Fair Value, Inputs, Level 1 [Member] | Investments In Corporate Debt Securities [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of assets | [2] | ||
Fair Value, Inputs, Level 2 [Member] | Cash and Cash Equivalents [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of assets | [1] | ||
Fair Value, Inputs, Level 2 [Member] | Investments In Corporate Debt Securities [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of assets | [2] | 24,597 | 19,530 |
Fair Value, Inputs, Level 3 [Member] | Cash and Cash Equivalents [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of assets | [1] | ||
Fair Value, Inputs, Level 3 [Member] | Investments In Corporate Debt Securities [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Fair value of assets | [2] | ||
[1] | Cash and cash equivalents primarily include investments in money market funds | ||
[2] | Investments in investment-grade corporate debt securities are classified as available for sale securities |
SCHEDULE OF STOCK-BASED COMPENS
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 3,267 | $ 1,277 | $ 6,124 | $ 2,513 |
General and Administrative Expense [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 2,069 | 848 | 3,875 | 1,561 |
Research and Development Expense [Member] | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 1,198 | $ 429 | $ 2,249 | $ 952 |
SUMMARY OF STOCK OPTION ACTIVIT
SUMMARY OF STOCK OPTION ACTIVITY (Details) $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($)$ / sharesshares | |
Share-based Payment Arrangement [Abstract] | |
Stock Options Underlying Shares, Outstanding beginning | shares | 9,503 |
Weighted-Average Exercise Price, Outstanding beginning balance | $ / shares | $ 9.10 |
Weighted-Average Remaining Contractual Term, Outstanding Beginning | 8 years 3 months 18 days |
Intrinsic Value, Exercisable | $ | |
Stock Options Underlying Shares, Granted | shares | 2,922 |
Weighted-Average Exercise Price, Granted | $ / shares | $ 7.70 |
Stock Options Underlying Shares, Exercised | shares | (19) |
Weighted-Average Exercise Price, Exercised | $ / shares | $ 2.50 |
Stock Options Underlying Shares, Forfeited or expired | shares | (303) |
Weighted-Average Exercise Price, Forfeited or expired | $ / shares | $ 5.26 |
Stock Options Underlying Shares, Outstanding ending balance | shares | 12,103 |
Weighted-Average Exercise Price, Outstanding ending balance | $ / shares | $ 8.87 |
Weighted-Average Remaining Contractual Term, Outstanding Ending | 8 years 3 months 18 days |
Intrinsic Value, Outstanding Ending | $ | $ 22,258 |
Stock Options Underlying Shares, Exercisable | shares | 4,367 |
Stock Option Weighted Average Exercise Price, Exercisable | $ / shares | $ 6.26 |
Weighted-Average Remaining Contractual Term, Exercisable | 7 years |
Intrinsic Value, Exercisable | $ | $ 15,851 |
SCHEDULE OF AGGREGATED INTRINSI
SCHEDULE OF AGGREGATED INTRINSIC VALUE OF STOCK OPTION EXERCISED (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | ||||
Cash proceeds from options exercised | $ 380 | $ 48 | $ 574 | |
Aggregate intrinsic value of options exercised | $ 323 | $ 239 | $ 953 |
SCHEDULE OF SHARE-BASED COMPENS
SCHEDULE OF SHARE-BASED COMPENSATION VALUATION OF ASSUMPTIONS (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | ||
Exercise price | $ 7.70 | $ 13.09 |
Expected volatility | 81.00% | 73.00% |
Expected dividends | 0.00% | 0.00% |
Expected term (in years) | 6 years 1 month 6 days | 6 years 2 months 12 days |
Risk-free interest rate | 1.07% | 1.05% |
STOCK OPTIONS (Details Narrativ
STOCK OPTIONS (Details Narrative) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 6 Months Ended | |||
Oct. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jan. 02, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 12,103 | 9,503 | |||
Expected dividends | 0.00% | 0.00% | |||
Share-based Payment Arrangement, Option [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 5.34 | ||||
Stock Option One [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested, Number of Shares | 2,240,000 | ||||
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount | $ 14.7 | ||||
Stock Option Two [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested, Number of Shares | 5,496,000 | ||||
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount | $ 32.4 | ||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 3 years 1 month 6 days | ||||
Two Thousand Seventeen Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 11,665,932 | ||||
Option exercisable expiration period | 10 years | ||||
Number of shares, description | the number of shares available for issuance under the 2017 Plan in an amount equal to (1) the difference between (x) 18% of the total shares of the Company’s common stock outstanding, on a fully diluted basis, on December 31st of the preceding calendar year, and (y) the total number of shares of the Company’s common stock reserved under the 2017 Plan on December 31st of such preceding calendar year or (2) an amount less than this calculated increase as determined by the board of directors. | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 197,801 | ||||
Two Thousand Seventeen Plan [Member] | Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 2,270,353 | ||||
Two Thousand and Twenty Inducement Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Option exercisable expiration period | 10 years | ||||
Number of options authorized | 2,000,000 | ||||
Twenty And Twenty Inducement Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 436,800 | ||||
Available for future grants shares | 1,563,200 |
WARRANTS (Details Narrative)
WARRANTS (Details Narrative) - $ / shares | 1 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2021 | Jul. 31, 2018 | Apr. 30, 2017 | |
Affiliate, Collateralized Security [Line Items] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 316,754 | |||
Series A Offering [Member] | ||||
Affiliate, Collateralized Security [Line Items] | ||||
Warrants outstanding, shares | 153,000 | 241,986 | ||
IPO [Member] | MDB Capital Group, LLC [Member] | ||||
Affiliate, Collateralized Security [Line Items] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,596,956 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 5 | |||
Warrants term | 5 years | |||
IPO [Member] | Warrant [Member] | ||||
Affiliate, Collateralized Security [Line Items] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 558,740 | |||
Warrants outstanding, shares | 1,462,842 | |||
IPO [Member] | Warrant [Member] | Cashless Basis [Member] | ||||
Affiliate, Collateralized Security [Line Items] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 134,114 | |||
Offering [Member] | Series A Warrant [Member] | ||||
Affiliate, Collateralized Security [Line Items] | ||||
Net of issuance shares | 129,719 | |||
Series A Convertible Redeemable Preferred Stock [Member] | Placement Agent [Member] | ||||
Affiliate, Collateralized Security [Line Items] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 558,740 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.50 | |||
Warrants term | 7 years |
SCHEDULE OF FIXED ASSETS (Detai
SCHEDULE OF FIXED ASSETS (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Fixed assets, net | $ 2,395 | $ 1,470 |
Fixed assets, net | (187) | (33) |
Fixed assets, net | 2,208 | 1,437 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, net | 838 | 828 |
Software Development [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, net | 287 | |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, net | 149 | 149 |
Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, net | 35 | 35 |
Clinical Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, net | 60 | 27 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, net | $ 1,026 | $ 431 |
FIXED ASSETS (Details Narrative
FIXED ASSETS (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 100 | $ 154 |
SCHEDULE OF LEASE COSTS (Detail
SCHEDULE OF LEASE COSTS (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Lessee Disclosure [Abstract] | ||||
Operating lease costs | $ 37 | $ 74 | ||
Variable lease costs | 6 | 12 | ||
Total lease costs | $ 43 | $ 86 |
SCHEDULE OF SUPPLEMENTAL BALANC
SCHEDULE OF SUPPLEMENTAL BALANCE SHEET INFORMATION (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Lessee, Lease, Description [Line Items] | ||
Lease right-of-use assets Non-current | $ 393 | $ 408 |
Lease liabilities Non-Current | $ 655 | $ 715 |
Weighted average remaining lease term Operating leases | 4 years 8 months 12 days | 5 years 2 months 12 days |
Weighted average discount rate Operating leases | 15.00% | 15.00% |
Accrued Expenses [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Lease liabilities Current | $ 114 | $ 72 |
SCHEDULE OF MATURITIES OF LEASE
SCHEDULE OF MATURITIES OF LEASE LIABILITIES (Details) $ in Thousands | Jun. 30, 2021USD ($) |
Lessee Disclosure [Abstract] | |
2021 (remaining) | $ 108 |
2022 | 221 |
2023 | 227 |
2024 | 232 |
2025 | 238 |
Thereafter | 41 |
Total lease payments | 1,067 |
Less: present value discount | 298 |
Present value of lease liabilities | $ 769 |
LEASES (Details Narrative)
LEASES (Details Narrative) | 6 Months Ended |
Jun. 30, 2021 | |
Lessee Disclosure [Abstract] | |
Description on lease | The Company’s lease portfolio consists of one office lease located in Red Bank, NJ. This lease is classified as an operating lease and has an initial term of 64 months from the lease commencement date, which began in October 2020. |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) $ in Millions | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Income Tax Disclosure [Abstract] | ||
Current State and Local Tax Expense (Benefit) | $ 1 | $ 0.5 |
Operating Loss Carryforwards | 11.9 | 6.8 |
Proceeds from net operating sale | $ 1 | $ 0.5 |