Provention Bio (PRVB) 10-Q 8 May 19 2019 Q1 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	3 Months Ended
	Mar. 31, 2019	May 06, 2019
Document And Entity Information
Entity Registrant Name	Provention Bio, Inc.
Entity Central Index Key	0001695357
Document Type	10-Q
Document Period End Date	Mar. 31, 2019
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Filer Category	Non-accelerated Filer
Entity Small Business Flag	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	true
Entity Common Stock, Shares Outstanding		37,361,562
Trading Symbol	PRVB
Document Fiscal Period Focus	Q1
Document Fiscal Year Focus	2019

Condensed Balance Sheets

Condensed Balance Sheets - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018
Current assets:
Cash and cash equivalents	$ 51,206	$ 58,539
Prepaid expenses and other current assets	698	2,990
Total assets	51,904	61,529
Current liabilities:
Accounts payable	779	568
Accrued expenses	2,195	1,303
Total current liabilities	2,974	1,871
Commitments and Contingencies (Note 5)
Stockholders' equity:
Preferred stock, $0.0001 par value; 25,000,000 shares authorized, no shares issued or outstanding at March 31, 2019 and December 31, 2018
Common stock, $0.0001 par value; 100,000,000 shares authorized; 37,361,562 issued and outstanding at March 31, 2019 and December 31, 2018	4	4
Additional paid-in capital	95,674	95,430
Accumulated deficit	(46,748)	(35,776)
Total stockholders' equity	48,930	59,658
Total liabilities, preferred stock and stockholders' equity	$ 51,904	$ 61,529

Condensed Balance Sheets (Paren

Condensed Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 2019	Dec. 31, 2018
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.0001	$ 0.0001
Preferred stock, shares authorized	25,000,000	25,000,000
Preferred stock, shares issued
Preferred stock, shares outstanding
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	100,000,000	100,000,000
Common stock, shares issued	37,361,562	37,361,562
Common stock, shares outstanding	37,361,562	37,361,562

Condensed Statements of Operati

Condensed Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Operating expenses:
Research and development	$ 10,022	$ 4,383
General and administrative	1,237	653
Total operating expenses	11,259	5,036
Loss from operations	(11,259)	(5,036)
Interest income	287	57
Change in fair value of warrant liability		(84)
Loss before income tax benefit	(10,972)	(5,063)
Income tax benefit
Net loss	(10,972)	(5,063)
Accretion on Series A Convertible Redeemable Preferred Stock		(125)
Net loss attributable to common stockholders	$ (10,972)	$ (5,188)
Net loss per common share, basic and diluted	$ (0.29)	$ (0.52)
Weighted average common shares outstanding, basic and diluted	37,362	10,000

Condensed Statement of Stockhol

Condensed Statement of Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands	Convertible Redeemable Preferred Stock [Member]	Common Stock [Member]	Additional Paid-In Capital [Member]	Accumulated Deficit [Member]	Total
Balance at Dec. 31, 2017	$ 26,185	$ 1	$ 3,264	$ (9,298)	$ (6,033)
Balance, shares at Dec. 31, 2017	11,382,000	10,000,000
Accretion of Series A Convertible Redeemable Preferred Stock to redemption value	$ 125		(125)		(125)
Accretion of Series A Convertible Redeemable Preferred Stock to redemption value, shares
Stock-based compensation			98		98
Net loss				(5,063)	(5,063)
Balance at Mar. 31, 2018	$ 26,310	$ 1	3,237	(14,361)	(11,123)
Balance, shares at Mar. 31, 2018	11,382,000	10,000,000
Balance at Dec. 31, 2018		$ 4	95,430	(35,776)	59,658
Balance, shares at Dec. 31, 2018		37,362,000
Stock-based compensation			244		244
Net loss				(10,972)	(10,972)
Balance at Mar. 31, 2019		$ 4	$ 95,674	$ (46,748)	$ 48,930
Balance, shares at Mar. 31, 2019		37,362,000

Condensed Statements of Cash Fl

Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Operating Activities
Net loss	$ (10,972)	$ (5,063)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	244	98
Change in fair value of warrant liability		84
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	2,292	(1,645)
Accounts payable	211	467
Accrued expenses	892	71
Net cash used in operating activities	(7,333)	(5,988)
Net decrease in cash and cash equivalents	(7,333)	(5,988)
Cash and cash equivalents at beginning of period	58,539	21,834
Cash and cash equivalents at end of period	51,206	15,846
Supplemental disclosure of non-cash financing transactions:
Accretion of Series A Convertible Redeemable Preferred Stock		$ 125

Description of Business and Bas

Description of Business and Basis of Presentation	3 Months Ended
	Mar. 31, 2019
Accounting Policies [Abstract]
Description of Business and Basis of Presentation	1. DESCRIPTON 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 clinical stage biopharmaceutical company, focused on the development and commercialization of novel therapeutics and innovative approaches to intercept and prevent 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, 2019 and for the three months ended March 31, 2019 and 2018 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, 2018 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 2018, as filed with the SEC on March 19, 2019. In the opinion of management, the unaudited financial information as of March 31, 2019 and for the three months ended March 31, 2019 and 2018, 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, 2019 and 2018 are not necessarily indicative of the operating results for the full fiscal year or any future period.

Liquidity

Liquidity	3 Months Ended
	Mar. 31, 2019
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, 2019, the Company had an accumulated deficit of $46.7 million . In April 2017, the Company completed its private placement of Series A Convertible Redeemable Preferred Stock. The Company issued an aggregate 11,381,999 shares of Series A Convertible Redeemable Preferred Stock at $2.50 per share. The Company received net proceeds of $26.7 million. In July 2018, the Company issued and sold an aggregate of 15,969,563 shares of common stock in its IPO at a public offering price of $4.00 per share. In connection with the IPO, the Company issued to MDB Capital Group, LLC (“MDB”), the underwriter in the IPO, and its designees warrants to purchase 1,596,956 shares of Common Stock at an exercise price of $5.00 per share. The Company received net proceeds from the IPO of $59.3 million, after deducting underwriting discounts and commissions of approximately $3.7 million and other offering expenses of approximately $0.8 million. Upon the closing of the IPO, all of the Company’s shares of redeemable convertible preferred stock outstanding at the time of the offering were automatically converted into 11,381,999 shares of common stock. In addition, the warrants issued in connection with the Series A Convertible Redeemable Preferred Stock also converted to warrants for the purchase of 558,740 shares of the Company’s common stock. 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 and the development of its administrative organization . The Company will require substantial additional financing to fund its operations and to continue to execute its strategy. The Company intends to raise capital through public or private equity financings. The sale of equity and 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. Based on the Company’s business plans, management believes that it has sufficient cash on hand to meet the Company’s obligations for at least the next twelve months from the issuance date of these financial statements.

Significant Accounting Policies

Significant Accounting Policies	3 Months Ended
	Mar. 31, 2019
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 operating and reporting segment. 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 three months from date of purchase to be cash equivalents. Marketable investments are those with original maturities in excess of three months. The Company has no significant 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. Financial instruments Cash and cash equivalents 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. Net loss per common share Net loss per share information is determined using the two-class method, which includes the weighted-average number of shares of common stock outstanding during the period and other securities that participate in dividends (a participating security). The Company considered the Series A Preferred Stock, all of which were automatically converted to common stock upon the Company’s IPO, to be participating securities because they included rights to participate in dividends, if any, with the common stock. Under the two-class method, basic net loss per share attributable to common stockholders is computed by dividing the net income attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. The net loss attributable to common stockholders is calculated by adjusting the net loss of the Company for the accretion on the Preferred Stock. Net losses are not allocated to preferred stockholders as they do not have an obligation to share in the Company’s net losses. In periods with net income attributable to common stockholders, the Company would allocate net income first to preferred stockholders based on dividend rights under the Company’s certificate of incorporation and then to preferred and common stockholders based on ownership interests. Diluted net loss per share attributable to common stockholders is computed using the more dilutive of (1) the two-class method or (2) the if-converted method. Diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders for all periods presented since the effect of potentially dilutive securities are anti-dilutive given the net loss of the Company. 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 Operations. 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 our 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, or ASC, 730, Research and Development. The Company accounts for non-refundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been received, rather than when the payment is made. 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 our 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, which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and non-employees, including stock options. Stock-based compensation expense is based on the grant date fair value estimated in accordance with the provisions of ASC 718 and is generally recognized as an expense over the requisite service period. For grants containing performance-based vesting provisions, the grant-date fair value of the performance-based stock options is recognized as compensation expense once it is probable that the performance condition will be achieved. The Company accounts for actual forfeitures in the period the forfeiture occurs. 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 U.S. Treasury yield at the date of grant for a term equivalent to the expected term of the option. In June 2018, the FASB issued ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting, Prior to the third quarter of 2018, the Company accounted for awards of equity instruments issued to non-employees in accordance with ASC Topic 505-50, Equity-Based Payment to Non-Employees, Stock-based compensation expense is included in both research and development expenses and general and administrative expenses in the Statements of Operations. Warrant liability In April 2017, the Company issued warrants to purchase shares of Series A Convertible Redeemable Preferred Stock in connection with the issuance of the Series A Preferred Stock. The Company accounted for these warrants as a liability in the financial statements because the underlying instrument into which the warrants were exercisable contained redemption provisions that were outside the Company’s control. Upon the completion of the IPO in July 2018, the warrants issued in connection with the Series A Convertible Redeemable Preferred Stock converted to warrants for the purchase of 558,740 shares of our common stock and the warrants no longer contain redemption provisions that are outside the Company’s control. The liability associated with these warrants was revalued just prior to the completion of the IPO, with the change in the fair value of the warrant liability charged to earnings. The warrant liability was then reclassified to additional paid-in capital upon the completion of the IPO in July 2018. The fair value of the warrants was determined using the Black-Scholes option-pricing model and were re-measured to fair value at each financial reporting period date with any changes in fair value recognized in the statements of operations. See Note 8 to our financial statements for further information. 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 In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) , 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, 2019
Loss Contingency Amount Reimbursed
Capitalization	4. CAPITALIZATION As of March 31, 2019, the Company had authorized 100,000,000 shares of Common Stock, $0.0001 par value per share, of which 37,361,562 shares were issued and outstanding. In addition, as of March 31, 2019, the Company had authorized 25,000,000 shares of Preferred Stock, $0.0001 par value per share, of which, none were issued and outstanding.

License and Other Agreements

License and Other Agreements	3 Months Ended
	Mar. 31, 2019
License And Other Agreements
License and Other Agreements	5. LICENSE AND OTHER AGREEMENTS 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 coxsackie virus 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. 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 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. As of March 31, 2019, the Company has not achieved any milestones that would trigger payments to Vactech. In April 2017, the Company entered into a License, Development and Commercialization Agreement with Janssen Pharmaceutica NV (the “CSF-1R License Agreement”), pursuant to which Janssen Pharmaceutica NV granted the Company exclusive global rights for the purpose of developing and commercializing JNJ-40346527 (renamed PRV-6527), a colony stimulating factor 1 receptor (CSF-1R) inhibitor for inflammatory bowel diseases including Crohn’s Disease and ulcerative colitis (UC). The Company is obligated to conduct a single Phase 2a proof-of-mechanism and proof-of-concept clinical trial for the Crohn’s Disease indication. Janssen will supply product for the clinical trial. At the conclusion of the Phase 2a study, Janssen will have an option to buy back the rights for future development for a one-time payment of $50.0 million and future single-digit royalties on future net sales for a period of 10 years from first sale or expiration of the intellectual property, whichever is shorter. If Janssen does not exercise its option to buy-back the rights, all rights will remain with the Company and it will be obligated to make contingent milestone payments to Janssen totaling $35.0 million upon the achievement of certain clinical and regulatory milestones for the first indication and an additional $20.0 million upon the achievement of certain clinical and regulatory milestones for a second indication. In addition, Provention has agreed to pay Janssen tiered single-digit royalties on net sales of any approved product based on the CSF-1R technology and three additional payments totaling $100.0 million upon the achievement of certain annual net sales levels. The CSF-1R License Agreement may be terminated by Provention without cause (in which case the exclusive global rights to the technology will transfer back to Janssen) and by either party upon a material breach and expires upon the expiration of Provention’s last obligation to make royalty payments to Janssen. As of March 31, 2019, the Company has not achieved any milestones that would trigger payments to Janssen. In April 2017, the Company entered into a License, Development and Commercialization Agreement with Janssen Sciences Ireland UC (the “TLR3 License Agreement”), pursuant to which Janssen Sciences Ireland UC granted the Company exclusive global rights for the purpose of developing and commercializing JNJ-42915925 (renamed PRV-300), an anti-Toll-Like Receptor 3 (TLR3) antibody. The Company evaluated PRV-300 for UC in a recently completed Phase 1b trial (the PULSE study). See Note 13 – Subsequent Events for the announcement of top-line results of the PULSE study. Under the TLR3 License Agreement, the Company is obligated to make contingent milestone payments to Janssen totaling $31.0 million upon the achievement of certain clinical and regulatory milestones for the first indication and an additional $17.0 million upon the achievement of certain clinical and regulatory milestones for a second indication. In addition, Provention has agreed to pay Janssen a single-digit royalty on net sales of any approved product based on the TLR3 technology and three additional payments totaling $60.0 million upon the achievement of certain annual net sales levels. Provention is obligated to use commercially reasonable efforts to develop and market TLR3. The TLR3 License Agreement may be terminated by the Company without cause (in which case the exclusive global rights to the technology will transfer back to Janssen) and by either party upon a material breach or insolvency of the other party and expires upon the expiration of the Company’s last obligation to make royalty payments to Janssen. As of March 31, 2019, the Company has not achieved any milestones that would trigger payments to Janssen. 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 coxsackie virus B vaccine (CVB), 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 which we expect will last for approximately 18 to 24 months. 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, 2019, the Company had paid Intravacc a total of approximately 5.0 million euros, or approximately $6.0 million, for services provided by Intravacc under the Intravacc Development Services Agreement. In May 2018, the Company entered into a License Agreement with MacroGenics, Inc. (the “MacroGenics License Agreement”), pursuant to which MacroGenics, Inc. (“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 shares of the Company’s common stock at an exercise price of $2.50 per share (See Note 11). The Company is obligated to make contingent milestone payments to MacroGenics totaling $42.5 million upon the achievement of certain developmental and approval milestones for the first indication, and an additional $22.5 million upon the achievement of certain regulatory approvals for a second indication. 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. Further, the Company is required to pay MacroGenics a low double-digit percentage of certain consideration to the extent received in connection with a future grant of rights to PRV-3279 by the Company to a third party. 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, but only with respect to the challenged patent. In May 2018, the Company entered into an Asset Purchase Agreement with MacroGenics (the “MacroGenics Asset Purchase Agreement”) 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 (See Note 11). The Company is obligated to pay MacroGenics contingent milestone payments totaling $170.0 million upon the achievement of certain regulatory approval milestones. 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. We have also agreed 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 $1.3 million and other consideration, for certain third-party intellectual property under agreements the Company is assuming 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 PRV-031 by the Company to a third party. The Company is obligated to use reasonable commercial efforts to develop and seek regulatory approval for PRV-031. As of March 31, 2019, the Company has not achieved any milestones that would trigger payments to MacroGenics. The Company recorded the warrants issued under MacroGenics License Agreement and the MacroGenics Asset Purchase Agreement at an estimated fair value of $1.64 per share, approximately $4.0 million in the aggregate, as license fee expense included as part of Research & Development Expense during the second quarter of 2018. See Note 11 of these condensed financial statements for further details of the warrants issued to MacroGenics. 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 has agreed to make an equity investment of up to $20.0 million in the Company, subject to certain terms and conditions set forth in the agreement. The equity investment will coincide with the Company’s future financing events or receipt of non-dilutive milestone payment from a third party including but not limited to Janssen related to the Company’s CSF-1R program. Amgen is also responsible for the manufacturing of PRV-015. Upon completion of the Phase 2b trial, a $150.0 million milestone payment is due from Amgen to the Company, plus an additional regulatory milestone payment, and single digit royalties on future sales. If Amgen elects not to pay the $150.0 million milestone, AMG 714 rights will be transferred to Company pursuant to a termination license agreement from Amgen and the Company. The Company will be obligated to make certain contingent milestone payments to Amgen and other third parties totaling up to $70.0 million upon the achievement of certain clinical and regulatory milestones and a low double-digit royalty on net sales of any approved product based on the IL-15 technology. The agreement may be terminated by the Company without cause (in which case the exclusive global rights to the technology will transfer back to Amgen) and by either party upon a material breach. The agreement expires upon the expiration of Amgen’s last obligation to make royalty payments to Provention (or, the Company’s last obligation to make royalty payments to Amgen, if the program rights are transferred to the Company.)

Net Loss Per Share of Common St

Net Loss Per Share of Common Stock	3 Months Ended
	Mar. 31, 2019
Earnings Per Share [Abstract]
Net Loss Per Share of Common Stock	6. NET LOSS PER SHARE OF COMMON STOCK The following table sets forth the computation of basic and diluted loss per share for the three months ended March 31, 2019 and 2018: Three Months Ended March 31, 2019 2018 Net loss, basic $ (10,972 ) $ (5,063 ) Accretion of Series A Convertible Redeemable Preferred Stock — (125 ) Net loss attributable to common stockholders $ (10,972 ) $ (5,188 ) Weighted average common shares outstanding, basic and diluted 37,362 10,000 Net loss per common share, basic and diluted $ (0.29 ) $ (0.52 ) The following potentially dilutive securities have been excluded from the computation of diluted weighted average shares outstanding as they would be antidilutive: Three Months Ended March 31, 2019 2018 Series A Convertible Redeemable Preferred Stock — 11,382 Warrants 4,588 559 Stock options 3,975 2,656

Accrued Expenses

Accrued Expenses	3 Months Ended
	Mar. 31, 2019
Payables and Accruals [Abstract]
Accrued Expenses	7. ACCRUED EXPENSES Accrued expenses consisted of the following: March 31, 2019 December 31, 2018 Accrued research and development costs $ 2,036 $ 1,023 Other accrued liabilities 93 154 Accrued professional fees 66 126 Total accrued expenses $ 2,195 $ 1,303

Fair Value of Assets and Liabil

Fair Value of Assets and Liabilities	3 Months Ended
	Mar. 31, 2019
Fair Value Disclosures [Abstract]
Fair Value of Assets and Liabilities	8. 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. The Company groups its assets and liabilities generally measured at fair value in three levels, based on the markets in which the assets and liabilities are traded and the reliability of the assumptions used to determine fair value. 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 Company had no assets or liabilities classified as Level 1 or Level 2 as of March 31, 2019 or December 31, 2018. Liability classified warrants issued in April 2017 to the placement agent in conjunction with the Series A Preferred Stock offering (see Note 9) were previously classified as Level 3. During the three months ended March 31, 2018, the Company recorded $0.1 million of expense related to the change in the fair value (an increase) of the Series A Preferred Stock warrant liability. Upon the completion of the IPO in July 2018, these warrants converted to warrants for the purchase of 558,740 shares of our common stock and no longer contain redemption provisions outside the Company’s control. The liability associated with these warrants was revalued just prior to the completion of the IPO, with the change in the fair value of the warrant liability charged to earnings. The warrant liability was then reclassified to additional paid-in capital upon the completion of the IPO in July 2018. There were no recurring or non-recurring measurements of fair value as of March 31, 2019, as of December 31, 2018 or during the three months ended March 31, 2019 with respect to assets and liabilities.

Series A Convertible Redeemable

Series A Convertible Redeemable Preferred Stock	3 Months Ended
	Mar. 31, 2019
Equity [Abstract]
Series A Convertible Redeemable Preferred Stock	9. SERIES A CONVERTIBLE REDEEMABLE PREFERRED STOCK In April 2017, the Company issued 11,381,999 shares of Series A Convertible Redeemable Preferred Stock for $2.50 per share which raised gross proceeds of $28.5 million and net cash proceeds of $26.7 million after deducting certain issuance costs including warrants. The Company classified the Series A Convertible Redeemable Preferred Stock outside of permanent equity based upon the terms of the instrument. See Note 11 for a description of the warrants issued to the placement agent in connection with this transaction. In connection with the closing of the Company’s IPO in July 2018, all of the Company’s shares of redeemable convertible preferred stock outstanding at the time of the offering were automatically converted into 11,381,999 shares of common stock.

Stock Options

Stock Options	3 Months Ended
	Mar. 31, 2019
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, 2019, there were options to purchase an aggregate of 3,975,099 shares of Common Stock outstanding under the 2017 Plan. Options issued under the 2017 Plan are exercisable for up to 10 years from the date of issuance. In connection with the completion of its IPO, 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 3,050,893 shares, as determined by the board of directors under the provisions described above, effective as of January 1, 2019. As of March 31, 2019, there were 2,935,218 shares available for future grants. Stock-based compensation Total stock-based compensation expense recognized for both employees and non-employees was as follows: Three Months Ended March 31, 2019 2018 Research and development $ 100 $ 54 General and administrative 144 44 Total share-based compensation expense $ 244 $ 98 Option activity The Company grants options with a service-based vesting requirement and also granted options with a performance-based vesting requirement. The service-based component vests 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, completion of the Company’s IPO, and certain other performance metrics. A summary of option activity for the three months ended March 31, 2019 are presented below: Weighted- Weighted- Average Average Remaining Underlying Exercise Contractual Intrinsic Stock Option Awards Shares Price Term Value Outstanding at December 31, 2018 3,476 $ 2.85 8.8 years $ — Granted 499 $ 2.26 Exercised — $ — Forfeited or expired — $ — Outstanding at Match 31, 2019 3,975 $ 2.78 8.7 years $ 34 Exercisable at March 31, 2019 1,076 $ 2.56 8.3 years $ — The weighted average grant-date fair value of options granted during the three months ended March 31, 2019 was $1.42 per share. As of March 31, 2019, there were approximately 903,000 unvested options subject to performance-based vesting criteria with approximately $1.3 million of unrecognized compensation expense. This expense will be recognized when each milestone becomes probable of occurring. In addition, as of March 31, 2019, there were approximately 1,996,000 unvested options outstanding subject to time-based vesting with approximately $2.9 million of unrecognized compensation expense which will be recognized over a period of 2.1 years. 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: Three months ended March 31, 2019 2018 Exercise Price $ 2.26 $ 2.50 Expected volatility 66 % 62 % Expected dividends — — Expected term (in years) 6.6 5.7 Risk-free interest rate 2.41 % 2.60 % 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 U.S. 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%, because the Company has not historically paid, and does not expect for the foreseeable future to pay, a dividend. ● 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. The expected term for options granted to non-employees is equal to the contractual term of the awards.

Warrants

Warrants	3 Months Ended
	Mar. 31, 2019
Warrants
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. The underlying instrument into which the warrants are exercisable contained redemption provisions that were outside the Company’s control. Accordingly, these warrants were considered liabilities and at issuance, the fair value of $0.9 million was recorded as a warrant liability against a reduction to the proceeds from the issuance of the Series A Convertible Redeemable Preferred Stock. 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 and because the warrants no longer contain redemption provisions outside the Company’s control, the Company determined that equity classification was appropriate. See Note 8 for further information. In May 2018, in connection with the MacroGenics License Agreement and the MacroGenics Asset Purchase Agreement, the Company issued warrants to MacroGenics to purchase 2,432,688 shares of the Company’s common stock at an exercise price of $2.50 per share. These warrants have a seven-year term. The Company recorded the warrants issued under MacroGenics License Agreement and the MacroGenics Asset Purchase Agreement at an estimated fair value of $1.64 per share, approximately $4.0 million in the aggregate, as license fee expense included as part of Research & Development Expense during the second quarter of 2018. The Company uses valuation methods and assumptions that consider, among other factors, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants issued to MacroGenics. The fair values of these instruments are determined using models based on inputs that require management judgment and estimates. The fair value of the warrants issued to MacroGenics were measured at issuance on May 7, 2018 using the Black-Scholes option pricing model based on the following assumptions: Equity value upon issuance on May 7, 2018 $ 2.58 Exercise Price $ 2.50 Expected volatility 62.0 % Expected dividends — Contractual term (in years) 7.0 Risk-free interest rate 2.86 % The MacroGenics warrants were evaluated under ASC 480, Distinguishing Liabilities from Equity, Derivatives and Hedging In July 2018, in connection with the Company’s completion of IPO, the Company issued to MDB, the underwriter in the IPO, and its designees warrants to purchase 1,596,956 shares of the Company’s common stock at an exercise price of $5.00 per share. These warrants have a five-year term. The Company uses valuation methods and assumptions that consider, among other factors, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants. The fair values of these instruments are determined using models based on inputs that require management judgment and estimates. The fair value of the warrants issued to MDB were measured at issuance on July 19, 2018 using the Black-Scholes option pricing model based on the following assumptions: Equity value upon issuance on July 19, 2018 $ 4.00 Exercise Price $ 5.00 Expected volatility 60.0 % Expected dividends — Contractual term (in years) 5.0 Risk-free interest rate 2.74 % The Company estimated the fair value of the warrants issued to MDB to be $1.90 per share, approximately $3.0 million in the aggregate, which was recorded as a cost of the IPO. The MDB warrants were evaluated under ASC 480 and ASC 815 and the Company determined that equity classification was appropriate.

Related Party Transactions

Related Party Transactions	3 Months Ended
	Mar. 31, 2019
Related Party Transactions [Abstract]
Related Party Transactions	12. RELATED PARTY TRANSACTIONS The Company paid transition service fees to Vactech of approximately $0.1 million during the three months ended March 31, 2018. The Company did not make any payments to Vactech during the three months ended March 31, 2019.

Subsequent Events

Subsequent Events	3 Months Ended
	Mar. 31, 2019
Subsequent Events [Abstract]
Subsequent Events	13. SUBSEQUENT EVENTS On May 8, 2019, the Company announced preliminary top-line results from its Phase 1b clinical trial (the PULSE study), which evaluated PRV-300, an anti-TLR3 (toll-like receptor 3) monoclonal antibody in 37 patients with active, moderate-to-severe UC. PRV-300 met the primary safety and tolerability endpoint over the twelve-week study period and also demonstrated TLR3 target engagement and proof-of-mechanism. However, improvements in secondary and exploratory clinical, endoscopic, histologic and other UC-related efficacy endpoints were not observed over background medication, suggesting that elevated TLR3 gene signatures previously observed in UC patients, as well as in PULSE, are downstream or circumstantial effects that do not contribute significantly to causal pathology. Therefore, while PRV-300 is a safe, pharmacologically active drug, it appears as that TLR3 may not be a useful target in UC.

Significant Accounting Polici_2

Significant Accounting Policies (Policies)	3 Months Ended
	Mar. 31, 2019
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 operating and reporting segment.
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 three months from date of purchase to be cash equivalents. Marketable investments are those with original maturities in excess of three months. The Company has no significant 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.
Financial Instruments	Financial instruments Cash and cash equivalents 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.
Net Loss Per Common Share	Net loss per common share Net loss per share information is determined using the two-class method, which includes the weighted-average number of shares of common stock outstanding during the period and other securities that participate in dividends (a participating security). The Company considered the Series A Preferred Stock, all of which were automatically converted to common stock upon the Company’s IPO, to be participating securities because they included rights to participate in dividends, if any, with the common stock. Under the two-class method, basic net loss per share attributable to common stockholders is computed by dividing the net income attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. The net loss attributable to common stockholders is calculated by adjusting the net loss of the Company for the accretion on the Preferred Stock. Net losses are not allocated to preferred stockholders as they do not have an obligation to share in the Company’s net losses. In periods with net income attributable to common stockholders, the Company would allocate net income first to preferred stockholders based on dividend rights under the Company’s certificate of incorporation and then to preferred and common stockholders based on ownership interests. Diluted net loss per share attributable to common stockholders is computed using the more dilutive of (1) the two-class method or (2) the if-converted method. Diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders for all periods presented since the effect of potentially dilutive securities are anti-dilutive given the net loss of the Company.
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 Operations. 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 our 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, or ASC, 730, Research and Development. The Company accounts for non-refundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been received, rather than when the payment is made. 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 our 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, which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and non-employees, including stock options. Stock-based compensation expense is based on the grant date fair value estimated in accordance with the provisions of ASC 718 and is generally recognized as an expense over the requisite service period. For grants containing performance-based vesting provisions, the grant-date fair value of the performance-based stock options is recognized as compensation expense once it is probable that the performance condition will be achieved. The Company accounts for actual forfeitures in the period the forfeiture occurs. 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 U.S. Treasury yield at the date of grant for a term equivalent to the expected term of the option. In June 2018, the FASB issued ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting, Prior to the third quarter of 2018, the Company accounted for awards of equity instruments issued to non-employees in accordance with ASC Topic 505-50, Equity-Based Payment to Non-Employees, Stock-based compensation expense is included in both research and development expenses and general and administrative expenses in the Statements of Operations.
Warrant Liability	Warrant liability In April 2017, the Company issued warrants to purchase shares of Series A Convertible Redeemable Preferred Stock in connection with the issuance of the Series A Preferred Stock. The Company accounted for these warrants as a liability in the financial statements because the underlying instrument into which the warrants were exercisable contained redemption provisions that were outside the Company’s control. Upon the completion of the IPO in July 2018, the warrants issued in connection with the Series A Convertible Redeemable Preferred Stock converted to warrants for the purchase of 558,740 shares of our common stock and the warrants no longer contain redemption provisions that are outside the Company’s control. The liability associated with these warrants was revalued just prior to the completion of the IPO, with the change in the fair value of the warrant liability charged to earnings. The warrant liability was then reclassified to additional paid-in capital upon the completion of the IPO in July 2018. The fair value of the warrants was determined using the Black-Scholes option-pricing model and were re-measured to fair value at each financial reporting period date with any changes in fair value recognized in the statements of operations. See Note 8 to our financial statements for further information.
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 In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) , 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)

Net Loss Per Share of Common _2

Net Loss Per Share of Common Stock (Tables)	3 Months Ended
	Mar. 31, 2019
Earnings Per Share [Abstract]
Schedule of Computation of Basic and Diluted Loss Per Share	The following table sets forth the computation of basic and diluted loss per share for the three months ended March 31, 2019 and 2018: Three Months Ended March 31, 2019 2018 Net loss, basic $ (10,972 ) $ (5,063 ) Accretion of Series A Convertible Redeemable Preferred Stock — (125 ) Net loss attributable to common stockholders $ (10,972 ) $ (5,188 ) Weighted average common shares outstanding, basic and diluted 37,362 10,000 Net loss per common share, basic and diluted $ (0.29 ) $ (0.52 )
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: Three Months Ended March 31, 2019 2018 Series A Convertible Redeemable Preferred Stock — 11,382 Warrants 4,588 559 Stock options 3,975 2,656

Accrued Expenses (Tables)

Accrued Expenses (Tables)	3 Months Ended
	Mar. 31, 2019
Payables and Accruals [Abstract]
Schedule of Accrued Expenses	Accrued expenses consisted of the following: March 31, 2019 December 31, 2018 Accrued research and development costs $ 2,036 $ 1,023 Other accrued liabilities 93 154 Accrued professional fees 66 126 Total accrued expenses $ 2,195 $ 1,303

Stock Options (Tables)

Stock Options (Tables)	3 Months Ended
	Mar. 31, 2019
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: Three Months Ended March 31, 2019 2018 Research and development $ 100 $ 54 General and administrative 144 44 Total share-based compensation expense $ 244 $ 98
Summary of Stock Option Activity	A summary of option activity for the three months ended March 31, 2019 are presented below: Weighted- Weighted- Average Average Remaining Underlying Exercise Contractual Intrinsic Stock Option Awards Shares Price Term Value Outstanding at December 31, 2018 3,476 $ 2.85 8.8 years $ — Granted 499 $ 2.26 Exercised — $ — Forfeited or expired — $ — Outstanding at Match 31, 2019 3,975 $ 2.78 8.7 years $ 34 Exercisable at March 31, 2019 1,076 $ 2.56 8.3 years $ —
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: Three months ended March 31, 2019 2018 Exercise Price $ 2.26 $ 2.50 Expected volatility 66 % 62 % Expected dividends — — Expected term (in years) 6.6 5.7 Risk-free interest rate 2.41 % 2.60 %

Warrants (Tables)

Warrants (Tables)	3 Months Ended
	Mar. 31, 2019
MacroGenics, Inc. [Member]
Schedule of Fair Value of Warrants Issued	The fair value of the warrants issued to MacroGenics were measured at issuance on May 7, 2018 using the Black-Scholes option pricing model based on the following assumptions: Equity value upon issuance on May 7, 2018 $ 2.58 Exercise Price $ 2.50 Expected volatility 62.0 % Expected dividends — Contractual term (in years) 7.0 Risk-free interest rate 2.86 %
MDB Capital Group, LLC [Member]
Schedule of Fair Value of Warrants Issued	The fair value of the warrants issued to MDB were measured at issuance on July 19, 2018 using the Black-Scholes option pricing model based on the following assumptions: Equity value upon issuance on July 19, 2018 $ 4.00 Exercise Price $ 5.00 Expected volatility 60.0 % Expected dividends — Contractual term (in years) 5.0 Risk-free interest rate 2.74 %

Liquidity (Details Narrative)

Liquidity (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended
	Jul. 31, 2018	Apr. 30, 2017	Mar. 31, 2019	Dec. 31, 2018
Accumulated deficit			$ 46,748	$ 35,776
IPO [Member]
Number of common stock shares issued and sold	15,969,563
Proceeds from initial public offering	$ 59,300
Underwriting discounts and commissions	3,700
Other offering expenses	$ 800
Preferred stock shares converted into common stock	11,381,999
IPO [Member] | MDB Capital Group, LLC [Member]
Public offering price per share	$ 4
Warrant to purchase shares of common stock	1,596,956
Warrant exercise price per share	$ 5
Series A Convertible Redeemable Preferred Stock [Member]
Number of preferred stock shares issued		11,381,999
Shares issued price per share		$ 2.50
Proceeds from issuance of Series A Convertible Redeemable Preferred Stock, net		$ 26,700
Series A Convertible Redeemable Preferred Stock [Member] | IPO [Member]
Warrant to purchase shares of common stock	558,740

Significant Accounting Polici_3

Significant Accounting Policies (Details Narrative)	3 Months Ended
	Mar. 31, 2019Segment	Jul. 31, 2018shares
Number of operating and reporting segment | Segment	1
IPO [Member] | Series A Convertible Redeemable Preferred Stock [Member]
Warrants to purchase a shares of common stock | shares		558,740

Capitalization (Details Narrati

Capitalization (Details Narrative) - $ / shares	Mar. 31, 2019	Dec. 31, 2018
Loss Contingency Amount Reimbursed
Common stock, shares authorized	100,000,000	100,000,000
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares issued	37,361,562	37,361,562
Common stock, shares outstanding	37,361,562	37,361,562
Preferred stock, shares authorized	25,000,000	25,000,000
Preferred stock, par value	$ 0.0001	$ 0.0001
Preferred stock, shares issued
Preferred stock, shares outstanding

License and Other Agreements (D

License and Other Agreements (Details Narrative) $ / shares in Units, € in Thousands, $ in Thousands	1 Months Ended				3 Months Ended	12 Months Ended
	Mar. 31, 2019EUR (€)	Nov. 30, 2018USD ($)	May 31, 2018USD ($)$ / sharesshares	Apr. 30, 2017USD ($)	Mar. 31, 2019USD ($)$ / shares	Dec. 31, 2017USD ($)$ / shares
License Agreement [Member] | Vactech [Member]
Estimated fair value of shares | $ / shares						$ 1.70
Payments on contingent milestone				$ 24,500
Payments made on tiered single-digit royalties				19,000
License Agreement [Member] | Vactech [Member] | First 18 Months [Member]
Payments on transition and advisory services				500
License Agreement [Member] | Vactech [Member] | Research and Development [Member]
Stock issued during period value, for license fee expense						$ 3,400
License, Development and Commercialization Agreement [Member] | Janssen Pharmaceutica NV [Member]
Payments made on tiered single-digit royalties				100,000
Amount receivable on achievement of milestone				$ 50,000
Future single-digit royalties on future net sales period				10 years
License, Development and Commercialization Agreement [Member] | Janssen Pharmaceutica NV [Member] | First Indication [Member]
Payments on contingent milestone				$ 35,000
License, Development and Commercialization Agreement [Member] | Janssen Pharmaceutica NV [Member] | Second Indication [Member]
Payments on contingent milestone				20,000
License, Development and Commercialization Agreement [Member] | Janssen Sciences Ireland UC [Member]
Payments made on tiered single-digit royalties				60,000
License, Development and Commercialization Agreement [Member] | Janssen Sciences Ireland UC [Member] | First Indication [Member]
Payments on contingent milestone				31,000
License, Development and Commercialization Agreement [Member] | Janssen Sciences Ireland UC [Member] | Second Indication [Member]
Payments on contingent milestone				$ 17,000
Intravacc Development Services Agreement [Member] | Institute of Translational Vaccinology [Member]
Payments on transition and advisory services | €	€ 10,000
Payments for business development					$ 6,000
Intravacc Development Services Agreement in EUR [Member] | Institute of Translational Vaccinology [Member]
Payments for business development					$ 5,000
MacroGenics License Agreement [Member] | MacroGenics, Inc. [Member]
Warrant to purchase shares of common stock | shares			270,299
Warrant exercise price | $ / shares			$ 2.50
MacroGenics License Agreement [Member] | MacroGenics, Inc. [Member] | Sales Milestones [Member]
Payments on contingent milestone			$ 225,000
MacroGenics License Agreement [Member] | MacroGenics, Inc. [Member] | First Indication [Member]
Payments on contingent milestone			42,500
MacroGenics License Agreement [Member] | MacroGenics, Inc. [Member] | Second Indication [Member]
Payments on contingent milestone			22,500
MacroGenics Asset Purchase Agreement [Member] | MacroGenics, Inc. [Member]
Payments on contingent milestone			170,000
Payments made on tiered single-digit royalties			$ 1,300
Warrant to purchase shares of common stock | shares			2,162,389
Warrant exercise price | $ / shares			$ 2.50
MacroGenics Asset Purchase Agreement [Member] | MacroGenics, Inc. [Member] | Sales Milestones [Member]
Payments on contingent milestone			$ 225,000
MacroGenics Asset Purchase Agreement & MacroGenics Asset Purchase Agreement [Member] | MacroGenics, Inc. [Member]
Fair value per share of each warrant | $ / shares					$ 1.64
MacroGenics License Agreement and MacroGenics Asset Purchase Agreement [Member] | MacroGenics, Inc. [Member] | Research and Development [Member]
Warrants issued during period, fair value					$ 4,000
License And Collaboration Agreement [Member]
Payments on contingent milestone		$ 70,000
License And Collaboration Agreement [Member] | Amgen Inc [Member]
Amount receivable on achievement of milestone		150,000
Equity investment		$ 20,000

Net Loss Per Share of Common _3

Net Loss Per Share of Common Stock - Schedule of Computation of Basic and Diluted Loss Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Earnings Per Share [Abstract]
Net loss, basic	$ (10,972)	$ (5,063)
Accretion of Series A Convertible Redeemable Preferred Stock		(125)
Net loss attributable to common stockholders	$ (10,972)	$ (5,188)
Weighted average common shares outstanding, basic and diluted	37,362	10,000
Net loss per common share, basic and diluted	$ (0.29)	$ (0.52)

Net Loss Per Share of Common _4

Net Loss Per Share of Common Stock - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Series A Convertible Redeemable Preferred Stock [Member]
Antidilutive securities excluded from computation of earnings per share		11,382,000
Warrants [Member]
Antidilutive securities excluded from computation of earnings per share	4,588,000	559,000
Stock Options [Member]
Antidilutive securities excluded from computation of earnings per share	3,975,000	2,656,000

Accrued Expenses - Schedule of

Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018
Payables and Accruals [Abstract]
Accrued research and development costs	$ 2,036	$ 1,023
Other accrued liabilities	93	154
Accrued professional fees	66	126
Total accrued expenses	$ 2,195	$ 1,303

Fair Value of Assets and Liab_2

Fair Value of Assets and Liabilities (Details Narrative)	Jul. 31, 2018shares
IPO [Member] | Series A Convertible Redeemable Preferred Stock [Member]
Warrant to purchase shares of common stock	558,740

Series A Convertible Redeemab_2

Series A Convertible Redeemable Preferred Stock (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended
	Jul. 31, 2018	Apr. 30, 2017
IPO [Member]
Preferred stock shares converted into common stock	11,381,999
Series A Convertible Redeemable Preferred Stock [Member]
Number of shares issued during period		11,381,999
Shares issued price per share		$ 2.50
Gross proceeds from issuance of convertible preferred stock		$ 28,500
Net proceeds from issuance of convertible preferred stock		$ 26,700

Stock Options (Details Narrativ

Stock Options (Details Narrative) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2019USD ($)$ / sharesshares
Annual dividend percentage	0.00%
Stock Option One [Member]
Weighted average grant-date fair value of options granted | $ / shares	$ 1.42
Number of options unvested	903,000
Unrecognized compensation expense | $	$ 1,300
Stock Option Two [Member]
Number of options unvested	1,996,000
Unrecognized compensation expense | $	$ 2,900
Unrecognized compensation period for recognition	2 years 1 month 6 days
2017 Plan [Member]
Number of options to purchase shares of common stock outstanding	3,975,099
Options exercisable term	10 years
Number of shares available for future grants	2,935,218
2017 Plan [Member] | Maximum [Member]
Number of options to purchase shares of common stock outstanding	3,050,863

Stock Options - Schedule of Sto

Stock Options - Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Total stock-based compensation expense	$ 244	$ 98
Research and Development [Member]
Total stock-based compensation expense	100	54
General and Administrative [Member]
Total stock-based compensation expense	$ 144	$ 44

Stock Options - Summary of Stoc

Stock Options - Summary of Stock Option Activity (Details) - Stock Option [Member] $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2019USD ($)$ / sharesshares
Stock Options Underlying Shares, Outstanding beginning | shares	3,476,000
Stock Options Underlying Shares, Granted | shares	499,000
Stock Options Underlying Shares, Exercised | shares
Stock Options Underlying Shares, Forfeited or expired | shares
Stock Options Underlying Shares, Outstanding ending balance | shares	3,975,000
Stock Options Underlying Shares, Exercisable | shares	1,076,000
Weighted-Average Exercise Price, Outstanding beginning balance | $ / shares	$ 2.85
Weighted-Average Exercise Price, Granted | $ / shares	2.26
Weighted-Average Exercise Price, Exercised | $ / shares
Weighted-Average Exercise Price, Forfeited or expired | $ / shares
Weighted-Average Exercise Price, Outstanding ending balance | $ / shares	2.78
Weighted-Average Exercise Price, Exercisable | $ / shares	$ 2.56
Weighted-Average Remaining Contractual Term, Outstanding Beginning	8 years 9 months 18 days
Weighted-Average Remaining Contractual Term, Outstanding Ending	8 years 8 months 12 days
Weighted-Average Remaining Contractual Term, Exercisable	8 years 3 months 19 days
Intrinsic Value, Outstanding Beginning | $
Intrinsic Value, Outstanding Ending | $	34
Intrinsic Value, Exercisable | $

Stock Options - Schedule of Sha

Stock Options - Schedule of Share-based Compensation Valuation of Assumptions (Details) - $ / shares	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Share-based Payment Arrangement [Abstract]
Exercise Price	$ 2.26	$ 2.50
Expected volatility	66.00%	62.00%
Expected dividends
Expected term (in years)	6 years 7 months 6 days	5 years 8 months 12 days
Risk-free interest rate	2.41%	2.60%

Warrants (Details Narrative)

Warrants (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended			3 Months Ended
	Jul. 31, 2018	May 31, 2018	Apr. 30, 2017	Mar. 31, 2019	Mar. 31, 2018
Fair value of warrant issued					$ 84
MacroGenics License Agreement and the MacroGenics Asset Purchase Agreement [Member]
Number of warrants issued to purchase common shares		2,432,688
Warrant exercise price per share		$ 2.50		$ 1.64
Warrant term		7 years
MacroGenics License Agreement and the MacroGenics Asset Purchase Agreement [Member] | Research and Development [Member]
License fee expense				$ 4,000
IPO [Member] | MDB Capital Group, LLC [Member]
Number of warrants issued to purchase common shares	1,596,956
Warrant exercise price per share	$ 5
Warrant term	5 years
Fair value of warrants for MDB				$ 1.90
Fair value of warrant issued				$ 3,000
IPO [Member] | Warrant [Member]
Number of warrants issued to purchase common shares	558,740
Series A Convertible Redeemable Preferred Stock [Member] | IPO [Member]
Number of warrants issued to purchase common shares	558,740
Series A Convertible Redeemable Preferred Stock [Member] | Placement Agent [Member]
Number of warrants issued to purchase common shares			558,740
Warrant exercise price per share			$ 2.50
Warrant liability			$ 900
Warrant term			7 years

Warrants - Schedule of Fair Val

Warrants - Schedule of Fair Value of Warrants Issued (Details)	Jul. 19, 2018$ / shares	May 07, 2018$ / shares	Mar. 31, 2019	Mar. 31, 2018
Expected dividends
Contractual term (in years)			6 years 7 months 6 days	5 years 8 months 12 days
Risk - free interest rate			2.41%	2.60%
MacroGenics, Inc. [Member]
Equity value up on issuance on July 19, 2018		2.58
Exercise price		$ 2.50
Expected volatility		62.00%
Expected dividends
Contractual term (in years)		7 years
Risk - free interest rate		2.86%
MDB Capital Group, LLC [Member]
Equity value up on issuance on July 19, 2018	4
Exercise price	$ 5
Expected volatility	60.00%
Expected dividends
Contractual term (in years)	5 years
Risk - free interest rate	2.74%

Related Party Transactions (Det

Related Party Transactions (Details Narrative) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Vactech [Member]
Related party transaction, fee amount		$ 1,000