Provention Bio (PRVB) 10-Q 6 May 21 2021 Q1 Quarterly report Financial data

Cover

Cover - shares	3 Months Ended
	Mar. 31, 2021	May 03, 2021
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Mar. 31, 2021
Document Fiscal Period Focus	Q1
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	Mar. 31, 2021	Dec. 31, 2020
Current assets:
Cash and cash equivalents	$ 180,357	$ 102,294
Marketable securities	26,848	19,530
Prepaid expenses and other current assets	4,446	4,730
Total current assets	211,651	126,554
Fixed assets, net	1,614	1,437
Operating lease right-of-use assets	401	408
Other assets	120	120
Total assets	213,786	128,519
Current liabilities:
Accounts payable	8,283	7,568
Accrued expenses and other current liabilities	13,950	9,162
Deferred revenue	4,519
Total current liabilities	26,752	16,730
Deferred revenue, net of current portion	2,481
Operating lease liabilities, long-term	686	715
Total liabilities	29,919	17,445
Commitments and Contingencies (Note 6)
Stockholders’ equity:
Preferred stock, $0.0001 par value; 25,000,000 shares authorized; no shares issued or outstanding at March 31, 2021 and December 31, 2020
Common stock, $0.0001 par value; 100,000,000 shares authorized; 63,374,738 shares issued and outstanding at March 31, 2021; 56,517,891 shares issued and outstanding at December 31, 2020	6	6
Additional paid-in capital	393,959	288,725
Accumulated other comprehensive loss	(16)	(15)
Accumulated deficit	(210,082)	(177,642)
Total stockholders’ equity	183,867	111,074
Total liabilities and stockholders’ equity	$ 213,786	$ 128,519

Condensed Balance Sheets (Una_2

Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Mar. 31, 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	100,000,000	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
	Mar. 31, 2021	Mar. 31, 2020
Operating expenses:
Research and development	$ 19,687	$ 9,090
General and administrative	12,781	3,775
Total operating expenses	32,468	12,865
Loss from operations	(32,468)	(12,865)
Interest income, net	28	283
Loss before income tax benefit	(32,440)	(12,582)
Income tax benefit
Net loss	$ (32,440)	$ (12,582)
Net loss per common share, basic and diluted	$ (0.52)	$ (0.26)
Weighted average common shares outstanding, basic and diluted	62,263	47,699
Net loss	$ (32,440)	$ (12,582)
Other comprehensive income (loss):
Unrealized gain (loss) on marketable securities	(1)	210
Total comprehensive loss	$ (32,441)	$ (12,372)

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
Issuance of common stock in connection with stock option exercises		194			194
Issuance of common stock in connection with stock option exercises, shares	55
Unrealized gain (loss) on marketable securities, net of tax			210		210
Stock-based compensation		1,236			1,236
Net loss				(12,582)	(12,582)
Ending balance, value at Mar. 31, 2020	$ 5	162,642	210	(91,643)	71,214
Ending Balance, shares at Mar. 31, 2020	47,713
Beginning balance, value at Dec. 31, 2020	$ 6	288,725	(15)	(177,642)	111,074
Beginning balance, shares at Dec. 31, 2020	56,518
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
Issuance of common stock in connection with stock option exercises		48			$ 48
Issuance of common stock in connection with stock option exercises, shares	19				19
Unrealized gain (loss) on marketable securities, net of tax			(1)		$ (1)
Stock-based compensation		2,857			2,857
Net loss				(32,440)	(32,440)
Ending balance, value at Mar. 31, 2021	$ 6	$ 393,959	$ (16)	$ (210,082)	$ 183,867
Ending Balance, shares at Mar. 31, 2021	63,375

Condensed Statements of Cash Fl

Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Operating activities
Net loss	$ (32,440)	$ (12,582)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	2,857	1,236
Amortization of premium and discounts on marketable securities	175	1
Non-cash operating lease expense	14
Depreciation	73
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	284	(865)
Accounts payable	715	1,761
Accrued interest receivable	83	(21)
Accrued expenses	4,752	1,302
Deferred revenue	7,000
Net cash used in operating activities	(16,487)	(9,168)
Investing activities
Purchase of marketable securities	(12,397)	(9,049)
Maturities of marketable securities	4,820	16,000
Purchase of fixed assets	(250)
Net cash (used in) provided by investing activities	(7,827)	6,951
Financing activities
Proceeds from underwritten public offering, net	102,329
Proceeds from stock option exercises	48	194
Net cash provided by financing activities	102,377	194
Net increase (decrease) in cash and cash equivalents	78,063	(2,023)
Cash and cash equivalents at beginning of period	102,294	39,165
Cash and cash equivalents at end of period	180,357	37,142
Supplemental disclosure of cash flow information:
Operating cash flows used for operating leases	$ 23

DESCRIPTION OF BUSINESS AND BAS

DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION	3 Months Ended
	Mar. 31, 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 March 31, 2021 and for the three months ended March 31, 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 March 31, 2021 and for the three months ended March 31, 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 months ended March 31, 2021 and 2020 are not necessarily indicative of the operating results for the full fiscal year or any future period.

LIQUIDITY

LIQUIDITY	3 Months Ended
	Mar. 31, 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 March 31, 2021, the Company had an accumulated deficit of $ 210.1 To date, the Company has not generated any revenues and has financed its operations primarily through equity offerings. 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 and its preclinical programs, 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 the Phase 2b PROACTIVE clinical study of PRV-015 in celiac disease, the first-in-human safety PROVENT study of the PRV-101 vaccine, and the planned Phase 2a PREVAIL clinical study of PRV-3279 in lupus. Based on the Company’s current business plans, management believes that its cash, cash equivalents and marketable securities on hand at March 31, 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	3 Months Ended
	Mar. 31, 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 March 31, 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 make 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 – License and Other Agreements, for specific details regarding the Company’s collaboration agreements. Since the Company’s inception and through March 31, 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 February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) , 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)

CAPITALIZATION

CAPITALIZATION	3 Months Ended
	Mar. 31, 2021
Capitalization
CAPITALIZATION	4. CAPITALIZATION As of March 31, 2021 and December 31, 2020, the Company had authorized 100,000,000 0.0001 63,374,738 56,517,891 25,000,000 0.0001 none

CASH, CASH EQUIVALENTS, AND MAR

CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES	3 Months Ended
	Mar. 31, 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 March 31, 2021 and December 31, 2020 were $ 180.4 102.3 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 $ 26.8 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 March 31, 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 March 31, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Corporate debt securities $ 26,864 $ — $ (16 ) $ 26,848 Total $ 26,864 $ — $ (16 ) $ 26,848 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 months ended March 31, 2021 and 2020, respectively, were as follows: SCHEDULE OF ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) 2021 2020 Three Months Ended March 31, 2021 2020 Beginning balance $ (15 ) $ — Current period changes in fair value before reclassifications, net of tax (1 ) 210 Amounts reclassified from accumulated other comprehensive income (loss), net of tax — — Other comprehensive income (loss) (1 ) 210 Ending balance $ (16 ) $ 210

LICENSE AND OTHER AGREEMENTS

LICENSE AND OTHER AGREEMENTS	3 Months Ended
	Mar. 31, 2021
License And Other Agreements
LICENSE AND OTHER AGREEMENTS	6. 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 shares of the Company’s common stock at an exercise price of $ 2.50 per share. The Company is obligated to pay MacroGenics contingent milestone payments totaling $ 170.0 million upon the achievement of certain regulatory approval milestones, including $ 60.0 million payable within 90 days of an approval of a BLA for a first indication in the United States. In addition, the Company is obligated to make contingent milestone payments to MacroGenics totaling $ 225.0 million upon the achievement of certain sales milestones. The Company has also agreed to pay MacroGenics a single-digit royalty on net sales of the product. The Company has also agreed to pay third-party obligations, including low single-digit royalties, a portion of which is creditable against royalties payable to MacroGenics, aggregate milestone payments of up to approximately $ 0.7 million and other consideration, for certain third-party intellectual property under agreements the Company assumed pursuant to the MacroGenics Asset Purchase Agreement. Further, the Company is required to pay MacroGenics a low double-digit percentage of certain consideration to the extent it is received in connection with a future grant of rights to teplizumab by the Company to a third party. The Company is obligated to use reasonable commercial efforts to develop and seek regulatory approval for teplizumab. 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 Provention 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 March 31, 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 11.5 1.0 37.0 135.0 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 million, consisting of the $ 6.0 million up-front payment and $ 9.5 million of the research, development and manufacturing funding expected to be received. which would not result in a significant reversal of revenue in a future period. The total transaction price was allocated to the single identified performance obligation. The regulatory and sales event-based milestone payments represent variable consideration, and the Company used the most likely amount method to estimate this variable consideration because the potential milestone payment is a binary event, as the Company will either receive the milestone payment or it will not. Given the high degree of uncertainty around achievement of these milestones, the Company determined the milestone amounts to be fully constrained and will not recognize revenue until the uncertainty associated with these payments is resolved. Any consideration related to royalties will be recognized if and when the related sales occur. The Company re-assesses the transaction price in each reporting period and when events whose outcomes are resolved or other changes in circumstances occur. The Company expects 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 per share for a total of $ 3.4 million as a license fee expense included as part of research & development expense for the year ended December 31, 2017. Provention paid Vactech a total of approximately $ 0.5 million for transition and advisory services during the first 18 months of the term of the agreement. In addition, Provention may be obligated to make a series of contingent milestone payments to Vactech totaling up to an additional $ 24.5 million upon the achievement of certain clinical development and regulatory filing milestones, of which $ 0.5 million became payable to Vactech in January 2021 upon the dosing of the first patient in the Phase 1 PROVENT study . In addition, the Company has agreed to pay Vactech tiered single-digit royalties on net sales of any approved product based on the CVB platform technology and three additional payments totaling $ 19.0 million upon the achievement of certain annual net sales levels. The Vactech License Agreement may be terminated by the Company on a country by country basis without cause (in which case the exclusive global rights to the technology will transfer back to Vactech) and by either party upon a material breach or insolvency of the other party. If the Company terminates the agreement with respect to two or more specified European countries, the agreement will be deemed terminated with respect to all of the EU, and if the Company terminates the agreement with respect to the United States, the agreement will be deemed terminated with respect to all of North America. The agreement expires upon the expiration of the Company’s last obligation to make royalty payments to Vactech. In March 2018, the Company entered into a Development Services Agreement with The Institute of Translational Vaccinology (the “Intravacc Development Services Agreement”), pursuant to which The Institute of Translational Vaccinology (“Intravacc”) will provide services related to process development, non-GMP and GMP manufacturing of the Company’s polyvalent CVB vaccine, including providing proprietary technology for manufacturing purposes. The Company will pay Intravacc approximately 10 million euros for their services over the development and manufacturing period. Each party retains its existing intellectual property and will share newly developed intellectual property via a fully-paid non-exclusive license between the parties for all development work through phase 1 clinical trials. Any future use, including commercial use, of Intravacc’s technology will be subject to a separate nonexclusive license agreement. The Intravacc Development Services Agreement may be terminated by us with ninety days’ notice without cause and by either party upon a material breach or insolvency of the other party. As of March 31, 2021, Intravacc has completed, and the Company has paid for, all material manufacturing services under the Intravacc Development Services Agreement. In April 2017, the Company entered into the Janssen CSF-1R License Agreement, pursuant to which Janssen Pharmaceutica NV (“Janssen”) granted the Company exclusive global rights to technology owned or controlled by Janssen for the purpose of developing and commercializing a colony stimulating factor 1 receptor (“CSF-1R”) inhibitor named JNJ-40346527 (renamed PRV-6527) for inflammatory bowel diseases including Crohn’s disease and UC. The Company evaluated PRV-6527 for Crohn’s disease in a recently completed Phase 2a clinical trial (the PRINCE study). In December 2019, Janssen declined its option to buy back the rights to PRV-6527 and as such, all rights will remain with the Company. The Company will be obligated to make contingent milestone payments to Janssen totaling $ 35.0 20.0 100.0

NET LOSS PER SHARE OF COMMON ST

NET LOSS PER SHARE OF COMMON STOCK	3 Months Ended
	Mar. 31, 2021
Earnings Per Share [Abstract]
NET LOSS PER SHARE OF COMMON STOCK	7. NET LOSS PER SHARE OF COMMON STOCK Basic and diluted net income (loss) per common share is determined by dividing net income (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 2021 2020 Three Months Ended March 31, 2021 2020 Net loss $ (32,440 ) $ (12,582 ) Weighted average shares of common stock outstanding - basic and diluted 62,263 47,699 Net loss per share of common stock, basic and diluted $ (0.52 ) $ (0.26 ) 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 March 31, 2021 2020 Stock options 9,698 6,674 Warrants 1,705 2,125

ACCRUED EXPENSES

ACCRUED EXPENSES	3 Months Ended
	Mar. 31, 2021
Payables and Accruals [Abstract]
ACCRUED EXPENSES	8. ACCRUED EXPENSES Accrued expenses consisted of the following: SCHEDULE OF ACCRUED EXPENSES March 31, 2021 December 31, 2020 Accrued research and development costs $ 8,507 $ 5,165 Accrued pre-commercial costs 1,864 1,191 Accrued professional fees 1,169 1,197 Accrued compensation 1,104 1,443 Accrued royalty and milestone payments 1,080 — Other accrued liabilities 226 166 Total accrued expenses $ 13,950 $ 9,162

FAIR VALUE OF ASSETS AND LIABIL

FAIR VALUE OF ASSETS AND LIABILITIES	3 Months Ended
	Mar. 31, 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 March 31, 2021 Financial Instruments Carried at Fair Value Quoted prices in active markets for identical items Significant other observable inputs Significant unobservable inputs (Level 1) (Level 2) (Level 3) Total Assets: Cash and cash equivalents 1 $ 180,357 $ — $ — $ 180,357 Investments in Corporate debt securities 2 — 26,848 — 26,848 December 31, 2020 Financial Instruments Carried at Fair Value Quoted prices in active markets for identical items Significant other observable inputs Significant (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	3 Months Ended
	Mar. 31, 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 March 31, 2021, there were options to purchase an aggregate of 9,697,881 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 2,165,852 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 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 March 31, 2021 2020 General and administrative $ 1,806 $ 713 Research and development 1,051 523 Total stock-based compensation expense $ 2,857 $ 1,236 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 three months ended March 31, 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 261 $ 15.32 Exercised (19 ) $ 2.50 Forfeited or expired (47 ) $ 13.21 Outstanding at March 31, 2021 9,698 $ 9.26 8.1 $ 27,069 Exercisable at March 31, 2021 3,944 $ 6.03 7.2 $ 20,357 The weighted average grant-date fair value of options granted during the three months ended March 31, 2021 was $ 10.47 1,849,000 12.9 3,905,000 24.8 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 Three Months Ended March 31, 2021 2020 Cash proceeds from options exercised $ 48 $ 194 Aggregate intrinsic value of options exercised 239 309 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 Three Months Ended March 31, 2021 2020 Exercise price $ 15.32 $ 12.80 Expected volatility 80 % 72 % Expected dividends — — Expected term (in years) 6.1 6.2 Risk-free interest rate 0.62 % 1.31 % 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	3 Months Ended
	Mar. 31, 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 shares of Series A Convertible Redeemable Preferred Stock with an exercise price of $ 2.50 per share with a seven-year term. Upon completion of the IPO in July 2018, the warrants automatically became warrants for the purchase of 558,740 shares of the Company’s common stock. As of March 31, 2021, a total of 316,754 warrants have been exercised on a cashless basis and there were 241,986 warrants outstanding related to the Series A Offering. 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-year 134,114 1,462,842

FIXED ASSETS

FIXED ASSETS	3 Months Ended
	Mar. 31, 2021
Property, Plant and Equipment [Abstract]
FIXED ASSETS	12. FIXED ASSETS Fixed assets consisted of the following: SCHEDULE OF FIXED ASSETS March 31, 2021 December 31, 2020 Leasehold improvements $ 838 $ 828 Software 272 — Furniture and fixtures 149 149 Office equipment 35 35 Clinical equipment 42 27 Construction in progress 384 431 1,720 1,470 Less accumulated depreciation (106 ) (33 ) Fixed assets, net $ 1,614 $ 1,437 Depreciation expense was $ 0.1 no

LEASES

LEASES	3 Months Ended
	Mar. 31, 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 Three Months Ended March 31, 2021 2020 Operating lease costs $ 37 $ — Variable lease costs 5 — Total lease costs $ 42 $ — Supplemental balance sheet information related to leases are as follows: SCHEDULE OF SUPPLEMENTAL BALANCE SHEET INFORMATION Classification As of March 31, 2021 As of December 31, 2020 Operating leases Lease right-of-use assets Non-current Operating lease right-of-use assets $ 401 $ 408 Lease liabilities Current Accrued expenses $ 108 $ 72 Non-current Operating lease liabilities, long-term $ 686 $ 715 Weighted average remaining lease term Operating leases 4.9 5.2 Weighted average discount rate Operating leases 15.0 % 15.0 % As of March 31, 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) $ 162 2022 221 2023 227 2024 232 2025 238 Thereafter 41 Total lease payments 1,121 Less: present value discount 327 Present value of lease liabilities $ 794

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	3 Months Ended
	Mar. 31, 2021
Subsequent Events [Abstract]
SUBSEQUENT EVENTS	14. SUBSEQUENT EVENTS In April 2021, the Company received net proceeds of $ 1.0

SIGNIFICANT ACCOUNTING POLICI_2

SIGNIFICANT ACCOUNTING POLICIES (Policies)	3 Months Ended
	Mar. 31, 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 March 31, 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 make 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 – License and Other Agreements, for specific details regarding the Company’s collaboration agreements. Since the Company’s inception and through March 31, 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 February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) , 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)

CASH, CASH EQUIVALENTS, AND M_2

CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES (Tables)	3 Months Ended
	Mar. 31, 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 March 31, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Corporate debt securities $ 26,864 $ — $ (16 ) $ 26,848 Total $ 26,864 $ — $ (16 ) $ 26,848 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 Three Months Ended March 31, 2021 2020 Beginning balance $ (15 ) $ — Current period changes in fair value before reclassifications, net of tax (1 ) 210 Amounts reclassified from accumulated other comprehensive income (loss), net of tax — — Other comprehensive income (loss) (1 ) 210 Ending balance $ (16 ) $ 210

NET LOSS PER SHARE OF COMMON _2

NET LOSS PER SHARE OF COMMON STOCK (Tables)	3 Months Ended
	Mar. 31, 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 2021 2020 Three Months Ended March 31, 2021 2020 Net loss $ (32,440 ) $ (12,582 ) Weighted average shares of common stock outstanding - basic and diluted 62,263 47,699 Net loss per share of common stock, basic and diluted $ (0.52 ) $ (0.26 )
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 March 31, 2021 2020 Stock options 9,698 6,674 Warrants 1,705 2,125

ACCRUED EXPENSES (Tables)

ACCRUED EXPENSES (Tables)	3 Months Ended
	Mar. 31, 2021
Payables and Accruals [Abstract]
SCHEDULE OF ACCRUED EXPENSES	Accrued expenses consisted of the following: SCHEDULE OF ACCRUED EXPENSES March 31, 2021 December 31, 2020 Accrued research and development costs $ 8,507 $ 5,165 Accrued pre-commercial costs 1,864 1,191 Accrued professional fees 1,169 1,197 Accrued compensation 1,104 1,443 Accrued royalty and milestone payments 1,080 — Other accrued liabilities 226 166 Total accrued expenses $ 13,950 $ 9,162

FAIR VALUE OF ASSETS AND LIAB_2

FAIR VALUE OF ASSETS AND LIABILITIES (Tables)	3 Months Ended
	Mar. 31, 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 March 31, 2021 Financial Instruments Carried at Fair Value Quoted prices in active markets for identical items Significant other observable inputs Significant unobservable inputs (Level 1) (Level 2) (Level 3) Total Assets: Cash and cash equivalents 1 $ 180,357 $ — $ — $ 180,357 Investments in Corporate debt securities 2 — 26,848 — 26,848 December 31, 2020 Financial Instruments Carried at Fair Value Quoted prices in active markets for identical items Significant other observable inputs Significant (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)	3 Months Ended
	Mar. 31, 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 March 31, 2021 2020 General and administrative $ 1,806 $ 713 Research and development 1,051 523 Total stock-based compensation expense $ 2,857 $ 1,236
SUMMARY OF STOCK OPTION ACTIVITY	A summary of option activity for the three months ended March 31, 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 261 $ 15.32 Exercised (19 ) $ 2.50 Forfeited or expired (47 ) $ 13.21 Outstanding at March 31, 2021 9,698 $ 9.26 8.1 $ 27,069 Exercisable at March 31, 2021 3,944 $ 6.03 7.2 $ 20,357
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 Three Months Ended March 31, 2021 2020 Cash proceeds from options exercised $ 48 $ 194 Aggregate intrinsic value of options exercised 239 309
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 Three Months Ended March 31, 2021 2020 Exercise price $ 15.32 $ 12.80 Expected volatility 80 % 72 % Expected dividends — — Expected term (in years) 6.1 6.2 Risk-free interest rate 0.62 % 1.31 %

FIXED ASSETS (Tables)

FIXED ASSETS (Tables)	3 Months Ended
	Mar. 31, 2021
Property, Plant and Equipment [Abstract]
SCHEDULE OF FIXED ASSETS	Fixed assets consisted of the following: SCHEDULE OF FIXED ASSETS March 31, 2021 December 31, 2020 Leasehold improvements $ 838 $ 828 Software 272 — Furniture and fixtures 149 149 Office equipment 35 35 Clinical equipment 42 27 Construction in progress 384 431 1,720 1,470 Less accumulated depreciation (106 ) (33 ) Fixed assets, net $ 1,614 $ 1,437

LEASES (Tables)

LEASES (Tables)	3 Months Ended
	Mar. 31, 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 Three Months Ended March 31, 2021 2020 Operating lease costs $ 37 $ — Variable lease costs 5 — Total lease costs $ 42 $ —
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 March 31, 2021 As of December 31, 2020 Operating leases Lease right-of-use assets Non-current Operating lease right-of-use assets $ 401 $ 408 Lease liabilities Current Accrued expenses $ 108 $ 72 Non-current Operating lease liabilities, long-term $ 686 $ 715 Weighted average remaining lease term Operating leases 4.9 5.2 Weighted average discount rate Operating leases 15.0 % 15.0 %
SCHEDULE OF MATURITIES OF LEASE LIABILITIES	As of March 31, 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) $ 162 2022 221 2023 227 2024 232 2025 238 Thereafter 41 Total lease payments 1,121 Less: present value discount 327 Present value of lease liabilities $ 794

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	Mar. 31, 2021	Dec. 31, 2020
Subsidiary, Sale of Stock [Line Items]
Retained Earnings (Accumulated Deficit)				$ 210,082	$ 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)	3 Months Ended
	Mar. 31, 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	Mar. 31, 2021	Dec. 31, 2020
Capitalization
Common Stock, Shares Authorized	100,000,000	100,000,000
Common Stock, Par or Stated Value Per Share	$ 0.0001	$ 0.0001
Common Stock, Shares, Issued	63,374,738	56,517,891
Common Stock, Shares, Outstanding	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
Preferred Stock, Shares Issued	0	0
Preferred Stock, Shares Outstanding	0	0

SCHEDULE OF AVAILABLE FOR SALE

SCHEDULE OF AVAILABLE FOR SALE SECURITIES (Details) - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Cash and Cash Equivalents [Line Items]
Amortized Cost	$ 26,864	$ 19,545
Gross Unrealized Gains
Gross Unrealized Losses	(16)	(15)
Fair Value	26,848	19,530
Corporate Debt Securities [Member]
Cash and Cash Equivalents [Line Items]
Amortized Cost	26,864	19,545
Gross Unrealized Gains
Gross Unrealized Losses	(16)	(15)
Fair Value	$ 26,848	$ 19,530

SCHEDULE OF ACCUMULATED OTHER C

SCHEDULE OF ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS) (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Cash and Cash Equivalents [Abstract]
Beginning balance	$ (15)
Current period changes in fair value before reclassifications, net of tax	(1)	210
Amounts reclassified from accumulated other comprehensive income (loss), net of tax
Other comprehensive income (loss)	(1)	210
Ending balance	$ (16)	$ 210

CASH, CASH EQUIVALENTS, AND M_3

CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES (Details Narrative) - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Cash and Cash Equivalents [Abstract]
Cash and Cash Equivalents, at Carrying Value	$ 180,357	$ 102,294
Available-for-sale Securities and Held-to-maturity Securities	$ 26,800	$ 19,500

LICENSE AND OTHER AGREEMENTS (D

LICENSE AND OTHER AGREEMENTS (Details Narrative) - USD ($) $ / shares in Units, $ in Millions	Feb. 25, 2021	Feb. 25, 2021	Jan. 31, 2021	Sep. 30, 2019	Jul. 31, 2019	Nov. 30, 2018	May 31, 2018	Apr. 30, 2017	Mar. 31, 2021	Mar. 31, 2018
Entity Listings [Line Items]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights									316,754
Collaboration revenue									$ 0
Deferred revenue									7
Huadong License Agreement [Member]
Entity Listings [Line Items]
[custom:TransactionPrice-0]	$ 15.5	$ 15.5
Number of warrants exercised	6
[custom:LicenseAgreementFundReceivable-0]	9.5	9.5
Intravacc Development Services Agreement [Member]
Entity Listings [Line Items]
Accounts Payable										$ 10
Macro Genics Inc [Member]
Entity Listings [Line Items]
Amount payable by the entity on achievement of various milestones							$ 225
Class of Warrant or Right, Number of Securities Called by Warrants or Rights					2,432,688
Number of warrants issuance shares					1,948,474
Macro Genics Inc [Member] | Asset Purchase Agreement [Member]
Entity Listings [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
Macro Genics Inc [Member] | Asset Purchase Agreement [Member] | Maximum [Member]
Entity Listings [Line Items]
Amount payable by the entity on achievement of various milestones							0.7
Macro Genics Inc [Member] | Asset Purchase Agreement [Member] | Biologics License Application [Member]
Entity Listings [Line Items]
Amount payable by the entity on achievement of various milestones							$ 60
Macro Genics Inc [Member] | License Agreement [Member]
Entity Listings [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
Macro Genics Inc [Member] | License Agreement [Member] | First Indication [Member]
Entity Listings [Line Items]
Amount payable by the entity on achievement of various milestones							42.5
Macro Genics Inc [Member] | License Agreement [Member] | Second Indication [Member]
Entity Listings [Line Items]
Amount payable by the entity on achievement of various milestones							22.5
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd [Member] | License Agreement [Member]
Entity Listings [Line Items]
License agreement amount payable							$ 1.1
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd [Member] | License Agreement [Member] | Research Development and Manufacturing Funding [Member]
Entity Listings [Line Items]
Upfront payment receivable		6
Future research and development funding receivable									$ 1
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd [Member] | License Agreement [Member] | Maximum [Member]
Entity Listings [Line Items]
Future development and regulatory milestones receivable	37	37
Future commercial milestones receivable	$ 135	135
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd [Member] | License Agreement [Member] | Maximum [Member] | Research Development and Manufacturing Funding [Member]
Entity Listings [Line Items]
Future research and development funding receivable		$ 11.5
Amgen Inc [Member]
Entity Listings [Line Items]
Amount payable by the entity on achievement of various milestones						$ 70
Amgen Inc [Member] | Private Placement [Member]
Entity Listings [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
Amgen Inc [Member] | License and Collaboration Agreement [Member]
Entity Listings [Line Items]
Potential proceeds from investment by collaborator						20
Amount payable by the entity on achievement of various milestones						$ 150
Vactech [Member] | License Agreement [Member]
Entity Listings [Line Items]
Amount payable by the entity on achievement of various milestones								$ 24.5
Shares Issued, Price Per Share								$ 1.70
Payments made on tiered single-digit royalties								$ 19
Vactech [Member] | License Agreement [Member] | Research and Development Expense [Member]
Entity Listings [Line Items]
Warrants issued during period, fair value								3.4
Vactech [Member] | License Agreement [Member] | First Eighteen Months [Member]
Entity Listings [Line Items]
Payments made for develpoment and manufacturing services								0.5
Vactech [Member] | License Agreement [Member] | Dosing Of First Patient In Phase 1 PROVENT Study [Member]
Entity Listings [Line Items]
Amount payable by the entity on achievement of various milestones			$ 0.5
Janssen Pharmaceutica NV [Member] | License Developmentand Commercialization Agreement [Member]
Entity Listings [Line Items]
Payments made on tiered single-digit royalties								100
Janssen Pharmaceutica NV [Member] | License Developmentand Commercialization Agreement [Member] | First Indication [Member]
Entity Listings [Line Items]
Amount payable by the entity on achievement of various milestones								35
Janssen Pharmaceutica NV [Member] | License Developmentand Commercialization Agreement [Member] | Second Indication [Member]
Entity Listings [Line Items]
Amount payable by the entity on achievement of various milestones								$ 20

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
	Mar. 31, 2021	Mar. 31, 2020
Earnings Per Share [Abstract]
Net loss	$ (32,440)	$ (12,582)
Weighted average shares of common stock outstanding - basic and diluted	62,263	47,699
Net loss per share of common stock, basic and diluted	$ (0.52)	$ (0.26)

SCHEDULE OF ANTIDILUTIVE SECURI

SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE (Details) - shares shares in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Stock Options [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	9,698	6,674
Warrants [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	1,705	2,125

SCHEDULE OF ACCRUED EXPENSES (D

SCHEDULE OF ACCRUED EXPENSES (Details) - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Payables and Accruals [Abstract]
Accrued research and development costs	$ 8,507	$ 5,165
Accrued pre-commercial costs	1,864	1,191
Accrued professional fees	1,169	1,197
Accrued compensation	1,104	1,443
Accrued royalty and milestone payments	1,080
Other accrued liabilities	226	166
Total accrued expenses	$ 13,950	$ 9,162

SCHEDULE OF ASSETS AND LIABILIT

SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE ON RECURRING BASIS (Details) - USD ($) $ in Thousands		Mar. 31, 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]	$ 180,357	$ 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]	26,848	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]	180,357	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]	26,848	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
	Mar. 31, 2021	Mar. 31, 2020
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	$ 2,857	$ 1,236
General and Administrative Expense [Member]
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	1,806	713
Research and Development Expense [Member]
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	$ 1,051	$ 523

SUMMARY OF STOCK OPTION ACTIVIT

SUMMARY OF STOCK OPTION ACTIVITY (Details) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 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, Outstanding Beginning | $
Stock Options Underlying Shares, Granted | shares	261
Weighted-Average Exercise Price, Granted | $ / shares	$ 15.32
Stock Options Underlying Shares, Exercised | shares	(19)
Weighted-Average Exercise Price, Exercised | $ / shares	$ 2.50
Stock Options Underlying Shares, Forfeited or expired | shares	(47)
Weighted-Average Exercise Price, Forfeited or expired | $ / shares	$ 13.21
Stock Options Underlying Shares, Outstanding ending balance | shares	9,698
Weighted-Average Exercise Price, Outstanding ending balance | $ / shares	$ 9.26
Weighted-Average Remaining Contractual Term, Outstanding Ending	8 years 1 month 6 days
Intrinsic Value, Outstanding Ending | $	$ 27,069
Stock Options Underlying Shares, Exercisable | shares	3,944
Weighted-Average Exercise Price, Exercisable | $ / shares	$ 6.03
Weighted-Average Remaining Contractual Term, Exercisable	7 years 2 months 12 days
Intrinsic Value, Exercisable | $	$ 20,357

SCHEDULE OF AGGREGATED INTRINSI

SCHEDULE OF AGGREGATED INTRINSIC VALUE OF STOCK OPTION EXERCISED (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Share-based Payment Arrangement [Abstract]
Cash proceeds from options exercised	$ 48	$ 194
Aggregate intrinsic value of options exercised	$ 239	$ 309

SCHEDULE OF SHARE-BASED COMPENS

SCHEDULE OF SHARE-BASED COMPENSATION VALUATION OF ASSUMPTIONS (Details) - $ / shares	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Share-based Payment Arrangement [Abstract]
Exercise Price	$ 15.32	$ 12.80
Expected volatility	80.00%	72.00%
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	0.62%	1.31%

STOCK OPTIONS (Details Narrativ

STOCK OPTIONS (Details Narrative) - USD ($) $ / shares in Units, $ in Millions	1 Months Ended	3 Months Ended
	Oct. 31, 2020	Mar. 31, 2021	Mar. 31, 2020	Jan. 02, 2021	Dec. 31, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of options outstanding		9,698			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		$ 10.47
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		1,849,000
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount		$ 12.9
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		3,905,000
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount		$ 24.8
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]
Number of options outstanding		9,697,881
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		2,165,852
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

WARRANTS (Details Narrative)

WARRANTS (Details Narrative) - $ / shares	Mar. 31, 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	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
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	Mar. 31, 2021	Dec. 31, 2020
Property, Plant and Equipment [Line Items]
Fixed assets, net	$ 1,720	$ 1,470
Fixed assets, net	(106)	(33)
Fixed assets, net	1,614	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	272
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	42	27
Construction in Progress [Member]
Property, Plant and Equipment [Line Items]
Fixed assets, net	$ 384	$ 431

FIXED ASSETS (Details Narrative

FIXED ASSETS (Details Narrative) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 73

SCHEDULE OF LEASE COSTS (Detail

SCHEDULE OF LEASE COSTS (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Lessee Disclosure [Abstract]
Operating lease costs	$ 37
Variable lease costs	5
Total lease costs	$ 42

SCHEDULE OF SUPPLEMENTAL BALANC

SCHEDULE OF SUPPLEMENTAL BALANCE SHEET INFORMATION (Details) - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Lessee, Lease, Description [Line Items]
Lease right-of-use assets Non-current	$ 401	$ 408
Lease liabilities Non-Current	$ 686	$ 715
Weighted average remaining lease term Operating leases	4 years 10 months 24 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	$ 108	$ 72

SCHEDULE OF MATURITIES OF LEASE

SCHEDULE OF MATURITIES OF LEASE LIABILITIES (Details) $ in Thousands	Mar. 31, 2021USD ($)
Lessee Disclosure [Abstract]
2021 (remaining)	$ 162
2022	221
2023	227
2024	232
2025	238
Thereafter	41
Total lease payments	1,121
Less: present value discount	327
Present value of lease liabilities	$ 794

LEASES (Details Narrative)

LEASES (Details Narrative)	3 Months Ended
	Mar. 31, 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.

SUBSEQUENT EVENTS (Details Narr

SUBSEQUENT EVENTS (Details Narrative) $ in Millions	1 Months Ended
	Apr. 30, 2021USD ($)
Subsequent Event [Member]
Subsequent Event [Line Items]
Proceeds from sale of net operating losses	$ 1