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| LEI | 5493003LM26XAVJKLD34 |
| CIK | 1695357 |
SEC Filings
All companies that sell securities in the United States must register with the Securities and Exchange Commission (SEC) and file reports on a regular basis.
These reports include company annual reports (10K, 10Q), news updates (8K), investor presentations (found in 8Ks), insider trades (form 4), ownership reports (13D, and 13G), and reports related to the specific securities sold, such as registration statements and prospectus. This page shows recent SEC filings related to Provention Bio Inc
SEC Filings (Chronological Order)
Halaman ini menyediakan daftar lengkap dan kronologis dari Pengajuan SEC, tidak termasuk pengajuan kepemilikan yang kami sediakan di tempat lain.
| May 8, 2023 |
15-12G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 15 CERTIFICATION AND NOTICE OF TERMINATION OF REGISTRATION UNDER SECTION 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR SUSPENSION OF DUTY TO FILE REPORTS UNDER SECTIONS 13 AND 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-38552 Provention Bio, Inc. (Exact name of registrant as specified |
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| April 28, 2023 |
PRVB / Provention Bio Inc / Sessa Capital (Master), L.P. - SC 13G/A Passive Investment SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 4)* PROVENTION BIO, INC. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 74374N102 (CUSIP Number) April 27, 2023 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designa |
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| April 27, 2023 |
As filed with the Securities and Exchange Commission on April 27, 2023 S-8 POS As filed with the Securities and Exchange Commission on April 27, 2023 Registration No. |
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| April 27, 2023 |
As filed with the Securities and Exchange Commission on April 27, 2023 S-8 POS As filed with the Securities and Exchange Commission on April 27, 2023 Registration No. |
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| April 27, 2023 |
As filed with the Securities and Exchange Commission on April 27, 2023 S-8 POS As filed with the Securities and Exchange Commission on April 27, 2023 Registration No. |
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| April 27, 2023 |
As filed with the Securities and Exchange Commission on April 27, 2023 POS AM As filed with the Securities and Exchange Commission on April 27, 2023 Registration No. |
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| April 27, 2023 |
As filed with the Securities and Exchange Commission on April 27, 2023 S-8 POS As filed with the Securities and Exchange Commission on April 27, 2023 Registration No. |
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| April 27, 2023 |
As filed with the Securities and Exchange Commission on April 27, 2023 POS AM As filed with the Securities and Exchange Commission on April 27, 2023 Registration No. |
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| April 27, 2023 |
As filed with the Securities and Exchange Commission on April 27, 2023 POS AM As filed with the Securities and Exchange Commission on April 27, 2023 Registration No. |
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| April 27, 2023 |
SC TO-T/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 (Amendment No. 3) Provention Bio, Inc. (Name of Subject Company (Issuer)) ZEST ACQUISITION SUB, INC. AVENTIS INC. SANOFI (Names of Filing Persons — Offerors) Common Stock, Par Value $0.0001 Per Share (Title of |
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| April 27, 2023 |
As filed with the Securities and Exchange Commission on April 27, 2023 S-8 POS As filed with the Securities and Exchange Commission on April 27, 2023 Registration No. |
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| April 27, 2023 |
As filed with the Securities and Exchange Commission on April 27, 2023 S-8 POS As filed with the Securities and Exchange Commission on April 27, 2023 Registration No. |
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| April 27, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 (Amendment No. 4) Solicitation/Recommendation Statement Under Section 14(d)(4) of the Securities Exchange Act of 1934 PROVENTION BIO, INC. (Name of Subject Company) PROVENTION BIO, INC. (Name of Person(s) Filing Statement) Common Stock, $0.0001 par value per share (Title of Class of Securities) 74374N102 (CUSIP |
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| April 27, 2023 |
Second Amended and Restated Bylaws (filed herewith). Exhibit 3.2 SECOND AMENDED AND RESTATED BYLAWS OF PROVENTION BIO, INC. (a Delaware corporation) Article I Stockholders Section 1. Annual Meetings. The annual meeting of the stockholders of Provention Bio, Inc. (the “Corporation”) for the election of directors and for the transaction of such other business as may properly come before the meeting shall be held each year at such date and time, within |
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| April 27, 2023 |
As filed with the Securities and Exchange Commission on April 27, 2023 S-8 POS As filed with the Securities and Exchange Commission on April 27, 2023 Registration No. |
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| April 27, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): April 27, 2023 Provention Bio, Inc. (Exact Name of Registrant as Specified in Charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Commission File Nu |
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| April 27, 2023 |
Third Amended and Restated Certificate of Incorporation (filed herewith). Exhibit 3.1 THIRD AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF PROVENTION BIO, INC. FIRST: The name of the corporation is: Provention Bio, Inc. SECOND: The address of the registered office of the Corporation in the State of Delaware is: 251 Little Falls Drive, in the City of Wilmington, County of New Castle, 19808. The name of its registered agent for service of process in the State of Del |
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| April 27, 2023 |
As filed with the Securities and Exchange Commission on April 27, 2023 S-8 POS As filed with the Securities and Exchange Commission on April 27, 2023 Registration No. |
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| April 26, 2023 |
Hart-Scott-Rodino waiting period expires for Sanofi’s acquisition of Provention Bio, Inc. EX-99.(a)(5)(D) Exhibit (a)(5)(D) Press Release Hart-Scott-Rodino waiting period expires for Sanofi’s acquisition of Provention Bio, Inc. Paris, France – April 26, 2023 – Sanofi announced today that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), applicable to Sanofi’s proposed acquisition of Provention Bio, Inc. (“Provention Bio”, NAS |
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| April 26, 2023 |
SC TO-T/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 (Amendment No. 2) Provention Bio, Inc. (Name of Subject Company (Issuer)) ZEST ACQUISITION SUB, INC. AVENTIS INC. SANOFI (Names of Filing Persons — Offerors) Common Stock, Par Value $0.0001 Per Share (Title of |
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| April 26, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 (Amendment No. 3) Solicitation/Recommendation Statement Under Section 14(d)(4) of the Securities Exchange Act of 1934 PROVENTION BIO, INC. (Name of Subject Company) PROVENTION BIO, INC. (Name of Person(s) Filing Statement) Common Stock, $0.0001 par value per share (Title of Class of Securities) 74374N102 (CUSIP |
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| April 19, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 (Amendment No. 2) Solicitation/Recommendation Statement Under Section 14(d)(4) of the Securities Exchange Act of 1934 PROVENTION BIO, INC. (Name of Subject Company) PROVENTION BIO, INC. (Name of Person(s) Filing Statement) Common Stock, $0.0001 par value per share (Title of Class of Securities) 74374N102 (CUSIP |
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| April 10, 2023 |
EX-99.(a)(5)(C) Exhibit (a)(5)(C) Press Release Sanofi announces withdrawal and refiling of Premerger Notification and Report Form under the HSR Act and extension of tender offer to acquire Provention Bio, Inc. Paris, France – April 10, 2023 – Sanofi announced today that it has withdrawn and refiled its Premerger Notification and Report Form under the Hart-Scott-Rodino Antitrust Improvements Act o |
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| April 10, 2023 |
SC TO-T/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 (Amendment No. 1) Provention Bio, Inc. (Name of Subject Company (Issuer)) ZEST ACQUISITION SUB, INC. AVENTIS INC. SANOFI (Names of Filing Persons — Offerors) Common Stock, Par Value $0.0001 Per Share (Title of |
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| April 10, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 (Amendment No. 1) Solicitation/Recommendation Statement Under Section 14(d)(4) of the Securities Exchange Act of 1934 PROVENTION BIO, INC. (Name of Subject Company) PROVENTION BIO, INC. (Name of Person(s) Filing Statement) Common Stock, $0.0001 par value per share (Title of Class of Securities) 74374N102 (CUSIP |
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| April 5, 2023 |
PRVB / Provention Bio Inc / Sessa Capital (Master), L.P. - SC 13G/A Passive Investment SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 3)* PROVENTION BIO, INC. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 74374N102 (CUSIP Number) March 31, 2023 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designa |
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| March 29, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO . Commission file number 001-38552 PROVENTION BIO, INC. (Ex |
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| March 29, 2023 |
As filed with the Securities and Exchange Commission on March 29, 2023 As filed with the Securities and Exchange Commission on March 29, 2023 Registration No. |
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| March 29, 2023 |
Exhibit 4.6 THIS WARRANT AND THE SHARES ISSUABLE UPON EXERCISE HEREOF HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY STATE SECURITIES LAWS. THEY MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, OR HYPOTHECATED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR, SUBJECT TO SECTION 11 HEREOF, AN OPINION OF COUNSEL (WHICH MAY BE COMPANY COUNSEL) REASONA |
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| March 29, 2023 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Provention Bio, Inc. |
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| March 29, 2023 |
Exhibit 10.30 First AMENDMENT TO LOAN AND SECURITY AGREEMENT This First Amendment to Loan and Security Agreement (this “Amendment”) is dated as of February 2, 2023 and is entered into by and among PROVENTION BIO, INC., a Delaware corporation, and each of its Subsidiaries from time to time party to the Loan Agreement as borrower (individually or collectively, as the context may require, “Borrower”) |
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| March 29, 2023 |
Exhibit 10.29 CERTAIN PORTIONS OF THIS EXHIBIT (INDICATED BY [***]) HAVE BEEN EXCLUDED PURSUANT TO ITEM 601(B)(10) OF REGULATION S-K BECAUSE THEY ARE BOTH NOT MATERIAL AND ARE THE TYPE THAT THE COMPANY TREATS AS PRIVATE AND CONFIDENTIAL. AMENDMENT NO. 1 TO ASSET PURCHASE AGREEMENT This Amendment No. 1 to the Asset Purchase Agreement (this “Amendment No. 1”), by and between MacroGenics, Inc., a Del |
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| March 24, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 (Rule 14d-101) Solicitation/Recommendation Statement Under Section 14(d)(4) of the Securities Exchange Act of 1934 PROVENTION BIO, INC. (Name of Subject Company) PROVENTION BIO, INC. (Name of Person(s) Filing Statement) Common Stock, $0.0001 par value per share (Title of Class of Securities) 74374N102 (CUSIP Num |
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| March 24, 2023 |
EX-(d)(4)-Confidentiality Agreement Exhibit (d)(4) Execution Version February 26, 2023 Sanofi 54, rue La Boétie 75008 Paris, France Attn: Loïc Gonnet Global Head of M&A Ladies and Gentlemen: In connection with Sanofi’s (“you” or “your”) interest in a possible negotiated transaction (the “Possible Transaction”) with Provention Bio, Inc. |
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| March 24, 2023 |
Exhibit 107 Calculation of Filing Fee Table SCHEDULE TO (Rule 14d-100) PROVENTION BIO, INC. |
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| March 24, 2023 |
EX-(d)(2)-Confidentiality Agreement Exhibit (d)(2) Execution Version CONFIDENTIALITY AGREEMENT This Confidentiality Agreement (the “Agreement”) is made on this 11th day of February, 2022 (the “Effective Date”) by and between: SANOFI, a French corporation, with a principal office at 54, rue La Boétie, 75008 Paris, France (“Sanofi”), and, PROVENTION BIO, INC. |
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| March 24, 2023 |
EX-99.A1B Exhibit (a)(1)(B) LETTER OF TRANSMITTAL To Tender Shares of Common Stock of TRANSLATE BIO, INC. at $25.00 Per Share, Net in Cash Pursuant to the Offer to Purchase dated March 24, 2023 by ZEST ACQUISITION SUB, INC. a wholly owned subsidiary of SANOFI THE OFFER AND WITHDRAWAL RIGHTS WILL EXPIRE AT ONE MINUTE FOLLOWING 11:59 P.M., EASTERN TIME, ON APRIL 20, 2023, UNLESS THE OFFER IS EXTENDE |
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| March 24, 2023 |
EX-(a)(1)(A)-OTP Table of Contents Exhibit (a)(1)(A) Offer To Purchase All Outstanding Shares of Common Stock of PROVENTION BIO, INC. |
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| March 24, 2023 |
SC TO-T UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 Provention Bio, Inc. (Name of Subject Company (Issuer)) ZEST ACQUISITION SUB, INC. AVENTIS INC. SANOFI (Names of Filing Persons — Offerors) Common Stock, Par Value $0.0001 Per Share (Title of Class of Securities |
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| March 24, 2023 |
EX-(a)(1)(E)-Summary Ad Exhibit (a)(1)(E) This announcement is neither an offer to purchase nor a solicitation of an offer to sell Shares (as defined below). |
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| March 24, 2023 |
Exhibit 10.1 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. CO-PROMOTION AGREEMENT by and between PROVENTION BIO, INC. and GENZYME CORPORATION dated as of October 4, 2022 TABLE OF CONTENTS Page ARTICLE 1 DEFINITIONS 1 ARTICLE 2 RIGHT OF F |
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| March 24, 2023 |
Exhibit 10.2 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of October 4, 2022 (the “Effective Date”), among Provention Bio, Inc., a Delaware |
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| March 24, 2023 |
EX-(d)(7)-Exclusivity Agreement Exhibit (d)(7) Execution Version February 26, 2023 STRICTLY CONFIDENTIAL Provention Bio, Inc. |
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| March 24, 2023 |
FIRST AMENDMENT TO CONFIDENTIALITY AGREEMENT EX-(d)(3)-Confidentiality 1st Amendment to Agreement Exhibit (d)(3) EXECUTION VERSION FIRST AMENDMENT TO CONFIDENTIALITY AGREEMENT This First Amendment to Confidentiality Agreement (the “First Amendment”) is made and entered into as of December 07th, 2022 (the “First Amendment Effective Date”) by and between: SANOFI, a French corporation, with a principal office at 46, avenue de la Grande Armée, 75017 Paris, France (“Sanofi”), and, PROVENTION BIO, INC. |
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| March 24, 2023 |
EX-(a)(1)(C)-BROKERLTR Exhibit (a)(1)(C) Offer to Purchase All Outstanding Shares of Common Stock of PROVENTION BIO, INC. |
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| March 24, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K/A CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): October 4, 2022 Provention Bio, Inc. (Exact Name of Registrant as Specified in Charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Commission File |
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| March 24, 2023 |
EX-(a)(1)(D)-CLIENTLTR Exhibit (a)(1)(D) Offer to Purchase All Outstanding Shares of Common Stock of PROVENTION BIO, INC. |
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| March 17, 2023 |
EX-99.1 Exhibit 99.1 Olivier CHARMEIL Executive Vice President General Medicines Paris, March 16, 2023 Dear friends at Provention Bio, Following this week’s news, I am grateful to your leadership for allowing me to share with you a few thoughts on behalf of Sanofi. I am very excited about the prospect of uniting our teams, once all due processes complete, as I am absolutely convinced that our orga |
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| March 17, 2023 |
SC TO-C 1 d458954dsctoc.htm SC TO-C UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 Provention Bio, Inc. (Name of Subject Company) ZEST ACQUISITION SUB, INC. AVENTIS INC. SANOFI (Names of Filing Persons — Offerors) Common Stock, Par Value $0.0001 Per Share (Title of |
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| March 13, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 SOLICITATION/RECOMMENDATION STATEMENT PURSUANT TO SECTION 14(d)(4) OF THE SECURITIES EXCHANGE ACT OF 1934 PROVENTION BIO, INC. (Name of Subject Company) PROVENTION BIO, INC. (Name of Person(s) Filing Statement) Common Stock, $0.0001 par value per share (Title of Class of Securities) 74374N102 (CUSIP Number of Co |
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| March 13, 2023 |
Exhibit 10.4 Execution Version Ashleigh Palmer March 12, 2023 Dear Ashleigh: As you know, Provention Bio, Inc., a Delaware corporation. (the “Company”) has, as of the date hereof, entered into an Agreement and Plan of Merger with Sanofi S.A., a French société anonyme (“Parent”), and Zest Acquisition Sub, Inc., a Delaware corporation and indirect wholly owned subsidiary of Parent (the “Merger Agree |
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| March 13, 2023 |
Exhibit 10.6 Execution Version Eleanor Ramos March 12, 2023 Dear Eleanor: As you know, Provention Bio, Inc., a Delaware corporation. (the “Company”) has, as of the date hereof, entered into an Agreement and Plan of Merger with Sanofi S.A., a French société anonyme (“Parent”), and Zest Acquisition Sub, Inc., a Delaware corporation and indirect wholly owned subsidiary of Parent (the “Merger Agreemen |
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| March 13, 2023 |
EX-99.1 Exhibit 99.1 Press Release Sanofi to acquire Provention Bio, adding to portfolio TZIELD, the first disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D) Paris and Red Bank, N.J. March 13, 2023 Sanofi and Provention Bio, Inc., a U.S.-based, publicly traded biopharmaceutical company focused on intercepting and preventing immune-mediated diseases including type 1 diabetes |
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| March 13, 2023 |
Joint press release, dated March 13, 2023, issued by the Company and Parent. Exhibit 99.1 Press Release Sanofi to acquire Provention Bio, adding to portfolio TZIELD, the first disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D) Paris and Red Bank, N.J. March 13, 2023 Sanofi and Provention Bio, Inc., a U.S.-based, publicly traded biopharmaceutical company focused on intercepting and preventing immune-mediated diseases including type 1 diabetes (T1D), |
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| March 13, 2023 |
SC TO-C UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 Provention Bio, Inc. (Name of Subject Company) ZEST ACQUISITION SUB, INC. AVENTIS INC. SANOFI (Names of Filing Persons — Offerors) Common Stock, Par Value $0.0001 Per Share (Title of Class of Securities) 74374N1 |
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| March 13, 2023 |
Exhibit 10.3 Execution Version SECOND AMENDMENT TO FIRST AMENDED EMPLOYMENT AGREEMENT This Second Amendment (this “Second Amendment”) to that certain First Amended Employment Agreement by and between Provention Bio, Inc. (the “Provention”) and Eleanor Ramos (“Executive”) dated June 9, 2020 (as amended by the Amendment to Employment Agreement dated September 9, 2022, the “Employment Agreement”), is |
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| March 13, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 13, 2023 (March 9, 2023) Provention Bio, Inc. (Exact Name of Registrant as Specified in Charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Co |
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| March 13, 2023 |
Exhibit 10.1 Execution Version SECOND AMENDMENT TO FIRST AMENDED EMPLOYMENT AGREEMENT This Second Amendment (this “Second Amendment”) to that certain First Amended Employment Agreement by and between Provention Bio, Inc. (the “Provention”) and Ashleigh Palmer (“Executive”) dated May 19, 2020 (as amended by the Amendment to Employment Agreement dated September 9, 2022, the “Employment Agreement”), |
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| March 13, 2023 |
Exhibit 10.2 Execution Version SECOND AMENDMENT TO EMPLOYMENT AGREEMENT This Second Amendment (this “Second Amendment”) to that certain Employment Agreement by and between Provention Bio, Inc. (the “Provention”) and Thierry Chauche (“Executive”) dated December 1, 2021 (as amended by the Amendment to Employment Agreement dated September 9, 2022, the “Employment Agreement”), is effective as of March |
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| March 13, 2023 |
Exhibit 2.1 Execution Version AGREEMENT AND PLAN OF MERGER among SANOFI S.A., ZEST ACQUISITION SUB, INC. and PROVENTION BIO, INC. Dated as of March 12, 2023 TABLE OF CONTENTS Article I THE OFFER 2 Section 1.1 The Offer 2 Section 1.2 Company Actions; Schedule 14D-9 4 Section 1.3 Stockholder Lists 5 Article II THE MERGER 5 Section 2.1 The Merger 5 Section 2.2 Closing; Effective Time 5 Section 2.3 Ef |
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| March 13, 2023 |
Amended and Restated Bylaws of Provention Bio, Inc., as adopted on March 9, 2023 Exhibit 3.1 AMENDED AND RESTATED BYLAWS OF PROVENTION BIO, INC. (a Delaware corporation) TABLE OF CONTENTS PAGES ARTICLE I CORPORATE OFFICES 1 1.1 REGISTERED OFFICE 1 1.2 OTHER OFFICES 1 ARTICLE II MEETINGS OF STOCKHOLDERS 1 2.1 PLACE OF MEETINGS 1 2.2 ANNUAL MEETING 1 2.3 SPECIAL MEETING 1 2.4 ADVANCE NOTICE PROCEDURES 2 2.5 NOTICE OF STOCKHOLDERS’ MEETINGS 7 2.6 QUORUM 7 2.7 ADJOURNED MEETING; N |
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| March 13, 2023 |
Exhibit 99.1 Press Release Sanofi to acquire Provention Bio, adding to portfolio TZIELD, the first disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D) Paris and Red Bank, N.J. March 13, 2023 Sanofi and Provention Bio, Inc., a U.S.-based, publicly traded biopharmaceutical company focused on intercepting and preventing immune-mediated diseases including type 1 diabetes (T1D), |
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| March 13, 2023 |
Exhibit 10.5 Execution Version Thierry Chauche March 12, 2023 Dear Thierry: As you know, Provention Bio, Inc., a Delaware corporation. (the “Company”) has, as of the date hereof, entered into an Agreement and Plan of Merger with Sanofi S.A., a French société anonyme (“Parent”), and Zest Acquisition Sub, Inc., a Delaware corporation and indirect wholly owned subsidiary of Parent (the “Merger Agreem |
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| March 13, 2023 |
Exhibit 99.2 Letter from Ashleigh Palmer, CEO Dear Colleagues, A few moments ago, we announced that we have entered into a definitive agreement for our Company to be acquired by our U.S. TZIELD co-promotion partner, Sanofi, for $25.00 per share in cash. We believe this is an enormously positive development for Provention Bio and is the best path forward to realize our purpose and intent to change |
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| February 21, 2023 |
SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Provention Bio, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 74374N102 (CUSIP Number) February 9, 2023 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the rule pursuant to |
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| February 16, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K/A (Amendment No. 1) CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 3, 2023 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction (IRS Employer of incorporation) Identificat |
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| February 14, 2023 |
SC 13G/A 1 tm236584d6sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 1)* Provention Bio, Inc. (Name of Issuer) Common Stock, $0.0001 par value (Title of Class of Securities) 74374N102 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of This Statement) Check the a |
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| February 14, 2023 |
PRVB / Provention Bio Inc / Sessa Capital (Master), L.P. Passive Investment SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (AMENDMENT NO. 2) * PROVENTION BIO, INC. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 74374N102 (CUSIP Number) December 31, 2022 (Date of Event which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant |
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| February 13, 2023 |
Exhibit 99.1 Provention Bio Announces Completion of $35 Million Equity Investment from Sanofi US Companies collaborating to expand access to TZIELD™ (teplizumab-mzwv), the first approved disease-modifying therapy for type 1 diabetes RED BANK, N.J., February 13, 2023 /PRNewswire/ — Provention Bio, Inc. (Nasdaq: PRVB) (the “Company”), a biopharmaceutical company dedicated to intercepting and prevent |
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| February 13, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): February 9, 2023 Provention Bio, Inc. (Exact Name of Registrant as Specified in Charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Commission File |
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| February 9, 2023 |
SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 1)* Provention Bio, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 74374N102 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the rule pursuant |
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| February 2, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 2, 2023 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction (IRS Employer of incorporation) Identification No.) 55 Broad S |
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| January 5, 2023 |
Provention Bio Announces Appointment of Rita Jain, M.D., to Board of Directors Exhibit 99.1 Provention Bio Announces Appointment of Rita Jain, M.D., to Board of Directors RED BANK, N.J., January 5, 2023 /PR Newswire/ ? Provention Bio, Inc. (Nasdaq: PRVB) (the ?Company?), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced the appointment of Rita Jain, M.D., to the Company?s Board of Directors. Dr. Jain is a biotechno |
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| January 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 3, 2023 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction (IRS Employer of incorporation) Identification No.) 55 Broad St |
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| December 6, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 30, 2022 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction (IRS Employer of incorporation) Identification No.) 55 Broad |
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| November 18, 2022 |
Exhibit 99.1 TZIELDTM (teplizumab-mzwv) approved by FDA as the first and only treatment indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients aged 8 years and older with Stage 2 T1D - TZIELD is the first disease-modifying therapy in T1D, a life-threatening autoimmune disease - In a clinical trial, in Stage 2 T1D patients, TZIELD delayed the median onset of S |
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| November 18, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 17, 2022 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction (IRS Employer of incorporation) Identification No.) 55 Broad |
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| November 3, 2022 |
Exhibit 99.1 Provention Bio Reports Third Quarter 2022 Financial Results and Provides Business Update Continues to Advance Preparations for Potential U.S. Commercial Launch of Teplizumab Ahead of November 17th FDA User Fee Goal Date RED BANK, N.J., November 3, 2022 /PRNewswire/ — Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediat |
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| November 3, 2022 |
Exhibit 4.1 THIS WARRANT AND THE SHARES ISSUABLE UPON EXERCISE HEREOF HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY STATE SECURITIES LAWS. THEY MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, OR HYPOTHECATED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR, SUBJECT TO SECTION 11 HEREOF, AN OPINION OF COUNSEL (WHICH MAY BE COMPANY COUNSEL) REASONA |
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| November 3, 2022 |
Exhibit 10.2 AMENDMENT TO EMPLOYMENT AGREEMENT This Amendment (the “Amendment”) to that certain First Amendment Employment Agreement by and between Provention Bio, Inc. (the “Provention”) and Ashleigh Palmer (“Executive”) dated May 19, 2020 (as amended, the “Employment Agreement”), is effective as of September 9, 2022. WHEREAS, Provention and Executive are parties to that certain Employment Agreem |
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| November 3, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 3, 2022 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction of incorporation) (IRS Employer Identification No.) 55 Broad S |
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| November 3, 2022 |
Exhibit 10.1 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [****], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. LOAN AND SECURITY AGREEMENT THIS LOAN AND SECURITY AGREEMENT is made and dated as of August 31, 2022 and is entered into by and among PROVENTION BIO, INC., a Delaware corporatio |
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| November 3, 2022 |
Exhibit 10.3 AMENDMENT TO EMPLOYMENT AGREEMENT This Amendment (the “Amendment”) to that certain Employment Agreement by and between Provention Bio, Inc. (the “Provention”) and Thierry Chauche (“Executive”) dated December 1, 2021 (as amended, the “Employment Agreement”), is effective as of September 9, 2022. WHEREAS, Provention and Executive are parties to that certain Employment Agreement; WHEREAS |
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| November 3, 2022 |
Exhibit 10.4 AMENDMENT TO EMPLOYMENT AGREEMENT This Amendment (the “Amendment”) to that certain First Amended Employment Agreement by and between Provention Bio, Inc. (the “Provention”) and Eleanor Ramos (“Executive”) dated June 9, 2020 (as amended, the “Employment Agreement”), is effective as of September 9, 2022. WHEREAS, Provention and Executive are parties to that certain Employment Agreement; |
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| November 3, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-38552 PROVENTION BI |
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| October 6, 2022 |
Exhibit 99.1 Provention Bio to Combine Forces with Sanofi to Support Potential U.S. Launch of Teplizumab for Delay in Onset of Clinical Type 1 Diabetes (T1D) in At-Risk Individuals ? Provention receives $20 million nonrefundable payment granting Sanofi exclusive right of first negotiation to in-license teplizumab globally for T1D ? U.S. copromotion agreement leverages Sanofi?s in-market infrastruc |
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| October 6, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): October 4, 2022 Provention Bio, Inc. (Exact Name of Registrant as Specified in Charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Commission File N |
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| August 31, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 31, 2022 Provention Bio, Inc. (Exact Name of Registrant as Specified in Charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Commission File N |
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| August 31, 2022 |
Provention Bio Announces $125 Million Term Loan Facility with Hercules Capital Exhibit 99.1 Provention Bio Announces $125 Million Term Loan Facility with Hercules Capital RED BANK, N.J., August 31st, 2022 ? Provention Bio, Inc. (Nasdaq: PRVB) (the ?Company?), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that the Company has secured a term loan facility of up to $125 million with Hercules Capital, Inc. (NYSE: H |
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| August 26, 2022 |
SC 13G 1 p22-2107sc13g.htm PROVENTION BIO, INC. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Provention Bio, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 74374N102 (CUSIP Number) August 16, 2022 (Date of Event Which Requires Filing of This Statement) Check the app |
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| August 4, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-38552 PROVENTION BIO, IN |
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| August 4, 2022 |
Results of Operations and Financial Condition, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 4, 2022 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction of incorporation) (IRS Employer Identification No.) 55 Broad Str |
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| August 4, 2022 |
Exhibit 99.1 Provention Bio Reports Second Quarter 2022 Financial Results and Provides Business Update -Teplizumab Biologics License Application (BLA) user fee goal date extended to November 17, 2022- -Company completes $60.0 million private placement- RED BANK, N.J., August 4, 2022 - Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-m |
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| August 2, 2022 |
Filed Pursuant to Rule 424(b)(3) Registration No. 333-266307 PROSPECTUS PROVENTION BIO, INC. 13,318,535 Shares of Common Stock Warrants to Purchase 13,318,535 Shares of Common Stock This prospectus relates to the resale or other disposition from time to time of up to (i) 13,318,535 shares of our common stock, par value $0.0001 per share (the “Common Stock”), and (ii) up to 13,318,535 shares of Com |
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| July 29, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-3 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 PROVENTION BIO, INC. (Exact name of registrant as specified in its charter) Delaware 81-5245912 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 55 Broad Street Red Bank, New Jersey 07701 (908) |
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| July 29, 2022 |
PROVENTION BIO, Inc. 55 Broad Street, 2nd Floor Red Bank, New Jersey 07701 CORRESP 1 filename1.htm PROVENTION BIO, Inc. 55 Broad Street, 2nd Floor Red Bank, New Jersey 07701 July 29, 2022 VIA EDGAR Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Dorrie Yale Re: Provention Bio, Inc. Registration Statement on Form S-3 (File No. 333-266307) Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 4 |
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| July 25, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-3 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 PROVENTION BIO, INC. (Exact name of registrant as specified in its charter) Delaware 81-5245912 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 55 Broad Street Red Bank, New Jersey 07701 (908) 336-0360 (Address, |
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| July 25, 2022 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Provention Bio, Inc. |
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| July 11, 2022 |
PRVB / Provention Bio Inc / Sessa Capital (Master), L.P. - SC 13G/A Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 1)* PROVENTION BIO, INC. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 74374N102 (CUSIP Number) July 7, 2022 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule |
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| July 11, 2022 |
Exhibit 1 JOINT FILING AGREEMENT Pursuant to Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, as amended, the undersigned agree, as of July 11, 2022, that only one statement containing the information required by Schedule 13G, and each amendment thereto, need be filed with respect to the ownership by each of the undersigned of shares of Common Stock of Provention Bio, Inc. |
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| July 8, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): July 7, 2022 Provention Bio, Inc. (Exact Name of Registrant as Specified in Charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Commission File Numb |
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| July 8, 2022 |
Exhibit 4.1 THIS WARRANT AND THE SHARES ISSUABLE HEREUNDER HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE ?ACT?), OR THE SECURITIES LAWS OF ANY STATE AND, EXCEPT AS SET FORTH IN SECTION 5.3 BELOW, MAY NOT BE OFFERED, SOLD, PLEDGED OR OTHERWISE TRANSFERRED UNLESS AND UNTIL REGISTERED UNDER SAID ACT AND LAWS OR, IN THE OPINION OF LEGAL COUNSEL IN FORM AND SUBSTANCE SATISF |
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| July 8, 2022 |
Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this ?Agreement?) is dated as of July 7, 2022 (the ?Effective Date?), among Provention Bio, Inc., a Delaware corporation (the ?Company?), and each purchaser identified on the signature pages hereto (each a ?Purchaser? and collectively the ?Purchasers?). WHEREAS, the Company and the Purchasers are executing and deliverin |
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| June 30, 2022 |
Provention Bio Announces Extension of FDA User Fee Goal Date for Teplizumab to November 17, 2022 Exhibit 99.1 Provention Bio Announces Extension of FDA User Fee Goal Date for Teplizumab to November 17, 2022 RED BANK, N.J., June 30, 2022 ? Provention Bio, Inc. (Nasdaq: PRVB) (the ?Company?), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended its review period by three month |
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| June 30, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 30, 2022 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction of incorporation) (IRS Employer Identification No.) 55 Broad Stre |
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| June 3, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 1, 2022 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction (IRS Employer of incorporation) Identification No.) 55 Broad Stree |
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| June 3, 2022 |
Exhibit 10.1 PROVENTION BIO, INC. SCIENTIFIC ADVISOR AGREEMENT THIS SCIENTIFIC ADVISOR AGREEMENT (this ?Agreement?) is made effective as of June 1, 2022 (the ?Effective Date?), by and between by and between PROVENTION BIO, INC., a Delaware corporation (the ?Company?), and Dr. Jeffrey Bluestone, PhD (the ?Advisor?; together with the Company, collectively the ?Parties?, and individually, a ?Party?). |
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| June 3, 2022 |
Provention Bio Announces Update to Board of Directors Exhibit 99.1 Provention Bio Announces Update to Board of Directors RED BANK, N.J., June 3, 2022 /PRNewswire/ ? Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced Dr. Jeffrey Bluestone?s decision to step down as a director on the Company?s board of directors to focus on his other commitments, including h |
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| May 20, 2022 |
Provention Bio, Inc. 2020 Inducement Plan, as amended. EX-10.1 2 ex10-1.htm Exhibit 10.1 provention bio, INC. 2020 INDUCEMENT PLAN, AS AMENDED ADOPTED: October 29, 2020 AMENDED: MAY 17, 2022 1. GENERAL. (a) Eligible Award Recipients. Awards under the Plan may only be granted to an individual not previously an Employee or Director of the Company, or to an individual following a bona fide period of non-employment with the Company, as an inducement mater |
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| May 20, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 17, 2022 Provention Bio, Inc. (Exact Name of Registrant as Specified in Charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Commission File Numb |
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| May 20, 2022 |
Exhibit 107 Provention Bio, Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1) Proposed Maximum Offering Price Per Share(2) Maximum Aggregate Offering Price(2) Fee Rate Amount of Registration Fee(2) Equity Common stock, par value $0.0001 per share 457(c) and 457(h) 2,500,000 s |
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| May 20, 2022 |
As filed with the Securities and Exchange Commission on May 20, 2022 As filed with the Securities and Exchange Commission on May 20, 2022 Registration No. |
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| May 5, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-38552 PROVENTION BIO, I |
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| May 5, 2022 |
Exhibit 99.1 Provention Bio Reports First Quarter 2022 Financial Results and Provides Business Update -Teplizumab Biologics License Application (BLA) resubmission accepted for review by FDA and user fee goal date set for August 17, 2022- -Company to host teplizumab commercial launch investor event on Thursday, May 19, 2022- RED BANK, N.J., May 5, 2022 - Provention Bio, Inc. (Nasdaq: PRVB), a bioph |
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| May 5, 2022 |
Results of Operations and Financial Condition, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 5, 2022 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction of incorporation) (IRS Employer Identification No.) 55 Broad Street |
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| April 5, 2022 |
United States Securities and Exchange Commission Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ? Filed by a Party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, For Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ? Definitive Proxy State |
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| April 5, 2022 |
DEF 14A 1 formdef14a.htm United States Securities and Exchange Commission Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, For Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) |
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| March 21, 2022 |
Regulation FD Disclosure, Other Events, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 21, 2022 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction of incorporation) (IRS Employer Identification No.) 55 Broad Str |
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| March 21, 2022 |
Exhibit 99.1 Provention Bio Announces FDA Acceptance of the Biologics License Application (BLA) Resubmission for Teplizumab for the Delay of Clinical Type 1 Diabetes in At-Risk Individuals - FDA Sets Goal Date of August 17, 2022- -If Approved Teplizumab will be the First Disease-Modifying Therapy for Type 1 Diabetes - RED BANK, N.J., March 21, 2022 ? Provention Bio, Inc. (Nasdaq: PRVB) (the ?Compa |
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| February 24, 2022 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Provention Bio, Inc. |
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| February 24, 2022 |
Results of Operations and Financial Condition, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 24, 2022 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware (State or other jurisdiction of incorporation) 81-5245912 (IRS Employer Identification No.) 55 Broad |
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| February 24, 2022 |
As filed with the Securities and Exchange Commission on February 24, 2022 POSASR 1 formposasr.htm As filed with the Securities and Exchange Commission on February 24, 2022 Registration No. 333-252045 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 POST-EFFECTIVE AMENDMENT NO. 1 TO FORM S-3 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 PROVENTION BIO, INC. (Exact name of registrant as specified in its charter) Delaware 81-5245912 (State |
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| February 24, 2022 |
Exhibit 107 Calculation of Filing Fee Tables Post-Effective Amendment to Form S-3 (Form Type) Provention Bio, Inc. |
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| February 24, 2022 |
Transition Agreement, dated November 1, 2021, between Provention and Andrew Drechsler + Exhibit 10.22 November 1, 2021 VIA EMAIL Andrew Drechsler Dear Andy: This letter agreement (this ?Agreement?) confirms the terms of the remainder of your employment with Provention Bio, Inc. (the ?Company?) and your engagement as a consultant by the Company, as follows: 1. Transition Period. (a) Transition. Subject to earlier termination as provided herein, from the date hereof through December 31 |
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| February 24, 2022 |
As filed with the Securities and Exchange Commission on February 24, 2022 As filed with the Securities and Exchange Commission on February 24, 2022 Registration No. |
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| February 24, 2022 |
Exhibit 99.1 Provention Bio Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update -Company resubmits Biologics License Application (BLA) for teplizumab for the delay of clinical type 1 diabetes (T1D) in at-risk individuals to the U.S. Food and Drug Administration (FDA)- RED BANK, N.J., February 24, 2022 - Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical c |
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| February 24, 2022 |
As filed with the Securities and Exchange Commission on February 24, 2022 As filed with the Securities and Exchange Commission on February 24, 2022 Registration No. |
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| February 24, 2022 |
Exhibit 107 Calculation of Filing Fee Tables Post-Effective Amendment to Form S-3 (Form Type) Provention Bio, Inc. |
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| February 24, 2022 |
Description of Registrant’s Securities. Exhibit 4.4 DESCRIPTION OF THE REGISTRANT?S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 As of February 24, 2022, Provention Bio, Inc. (the ?Company?) had one class of common stock registered under Section 12 of the Securities Exchange Act of 1934, as amended (the ?Exchange Act?). The following description of the Company?s common stock is a summary and does n |
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| February 24, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ? ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2021 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO . Commission file number 001-38552 PROVENTION BIO, INC. (Ex |
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| February 24, 2022 |
Employment Agreement, dated December 1, 2021, between Provention and Thierry Chauche + Exhibit 10.23 EMPLOYMENT AGREEMENT This EMPLOYMENT AGREEMENT (this ?Agreement?), effective December 1, 2021 or such other date as agreed by the parties hereto (the ?Effective Date?), is by and between PROVENTION BIO, INC., a Delaware corporation (the ?Company?) and Thierry Chauche (the ?Executive?). WITNESSETH WHEREAS, the Company desires to employ the Executive as its Chief Financial Officer, and |
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| February 22, 2022 |
Exhibit 99.1 Provention Bio Announces Biologics License Application (BLA) Resubmission for Teplizumab to Address Complete Response Letter (CRL) RED BANK, N.J., February 22, 2022 ? Provention Bio, Inc. (Nasdaq: PRVB) (the ?Company?), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced it has resubmitted the Biologics License Application (BL |
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| February 22, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 22, 2022 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction of incorporation) (IRS Employer Identification No.) 55 Broad |
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| February 14, 2022 |
SCHEDULE 13G CUSIP No. 74374N102 Exhibit 1 JOINT FILING AGREEMENT Pursuant to Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, as amended, the undersigned agree, as of February 14, 2022, that only one statement containing the information required by Schedule 13G, and each amendment thereto, need be filed with respect to the ownership by each of the undersigned of shares of Common Stock |
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| February 14, 2022 |
PRVB / Provention Bio Inc / PERCEPTIVE ADVISORS LLC - SC 13G/A Passive Investment SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 5)* Provention Bio, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 74374N 102 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to des |
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| February 14, 2022 |
PRVB / Provention Bio Inc / Sessa Capital (Master), L.P. Passive Investment SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (AMENDMENT NO. )* PROVENTION BIO, INC. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 74374N102 (CUSIP Number) December 31, 2021 (Date of Event which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to |
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| February 14, 2022 |
EXHIBIT 1 AGREEMENT The persons below hereby agree that the Schedule 13G to which this agreement is attached as an exhibit, as well as all future amendments to such Schedule 13G, shall be filed on behalf of each of them. |
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| January 27, 2022 |
Exhibit 99.1 Provention Bio Resubmitting Biologics License Application for Delay of Clinical Type 1 Diabetes in At-Risk Individuals Following Type B Meeting with the FDA - Company to Host Conference Call Tomorrow, January 28th at 8:00 AM ET - RED BANK, N.J., January 27, 2022 ? Provention Bio, Inc. (Nasdaq: PRVB) (the ?Company?), a biopharmaceutical company dedicated to intercepting and preventing |
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| January 27, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 27, 2022 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction of incorporation) (IRS Employer Identification No.) 55 Broad S |
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| November 22, 2021 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 22, 2021 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware (State or other jurisdiction of incorporation) 81-5245912 (IRS Employer Identification No.) 55 Broad |
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| November 22, 2021 |
Provention Bio Provides Regulatory Update for Teplizumab At-Risk Type 1 Diabetes Approval Pathway Exhibit 99.1 Provention Bio Provides Regulatory Update for Teplizumab At-Risk Type 1 Diabetes Approval Pathway RED BANK, N.J., November 22, 2021 ? Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today provided an update on its ongoing efforts to address U.S. Food and Drug Administration (FDA) considerations cited in |
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| November 4, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-38552 PROVENTION BI |
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| November 4, 2021 |
Exhibit 99.2 Provention Bio Announces Appointment of Thierry Chauche as Chief Financial Officer Andrew Drechsler to Retire as Chief Financial Officer in December RED BANK, N.J., November 4, 2021 - Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that Thierry Chauche will become Chief Financial Officer |
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| November 4, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 4, 2021 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction of incorporation) (IRS Employer Identification No.) 55 Broad S |
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| November 4, 2021 |
Provention Bio Reports Third Quarter 2021 Financial Results and Provides Business Update Exhibit 99.1 Provention Bio Reports Third Quarter 2021 Financial Results and Provides Business Update RED BANK, N.J., November 4, 2021 - Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today reported financial results for the third quarter ended September 30, 2021 and provided a business update. ?During the third qu |
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| August 5, 2021 |
Results of Operations and Financial Condition, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 5, 2021 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction of incorporation) (IRS Employer Identification No.) 55 Broad Str |
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| August 5, 2021 |
Provention Bio Reports Second Quarter 2021 Financial Results and Provides Business Update Exhibit 99.1 Provention Bio Reports Second Quarter 2021 Financial Results and Provides Business Update RED BANK, N.J., August 5, 2021 - Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today reported financial results for the second quarter ended June 30, 2021 and provided a business update. ?The significant steps we |
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| August 5, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-38552 PROVENTION BIO, IN |
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| July 6, 2021 |
Exhibit 99.1 Provention Bio Receives Complete Response Letter (CRL) to Biologics License Application (BLA) for Teplizumab for the Delay of Clinical Type 1 Diabetes (T1D) in At-risk Individuals Previously reported pharmacokinetic (PK) drug product comparability considerations remain outstanding The CRL did not cite any clinical deficiencies related to the efficacy and safety data packages submitted |
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| July 6, 2021 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 6, 2021 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction (IRS Employer of incorporation) Identification No.) 55 Broad Stree |
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| June 7, 2021 |
PRVB / Provention Bio Inc / Venrock Healthcare Capital Partners II, L.P. - SC 13G Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. )* Provention Bio, Inc. (Name of Issuer) Common Stock, $0.0001 par value (Title of Class of Securities) 74374N102 (CUSIP Number) May 26, 2021 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the rule pursuant to |
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| May 28, 2021 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 27, 2021 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware (State or other jurisdiction of incorporation) 81-5245912 (IRS Employer Identification No.) 55 Broad Stree |
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| May 28, 2021 |
EX-99.1 2 ex99-1.htm Exhibit 99.1 FDA Advisory Committee Votes in Favor of the Benefits of Teplizumab Outweighing the Risks in Support of Approval to Delay Clinical Type 1 Diabetes (T1D) If approved, teplizumab will be the first disease-modifying therapy in T1D RED BANK, N.J., May 27, 2021 — Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing i |
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| May 25, 2021 |
Exhibit 99.1 Provention Bio Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Teplizumab RED BANK, N.J., May 25, 2021 ? Provention Bio, Inc., (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, announced today that the U.S. Food and Drug Administration (FDA) posted briefing documents for the May 27, 2021 Endocrin |
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| May 25, 2021 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 25, 2021 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware (State or other jurisdiction of incorporation) 81-5245912 (IRS Employer Identification No.) 55 Broad Stree |
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| May 14, 2021 |
Exhibit 3.1 CERTIFICATE OF AMENDMENT TO THE SECOND AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF PROVENTION BIO, INC. Provention Bio, Inc. (the ?Corporation?), a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of Delaware (the ?DGCL?), DOES HEREBY CERTIFY: FIRST: The name of the Corporation is Provention Bio, Inc. The orig |
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| May 14, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 12, 2021 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction of incorporation) (IRS Employer Identification No.) 55 Broad Stree |
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| May 6, 2021 |
Exhibit 10.1 PROVENTION BIO, INC. STOCK OPTION GRANT AGREEMENT (2020 INDUCEMENT PLAN) This Stock Option Grant Agreement (the ?Grant Agreement?) is made and entered into effective on the Date of Grant set forth in Exhibit A (the ?Date of Grant?) by and between Provention Bio, Inc., a Delaware corporation (the ?Company?), and the individual named in Exhibit A hereto (the ?Optionee?). Capitalized ter |
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| May 6, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-38552 PROVENTION BIO, I |
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| May 6, 2021 |
Results of Operations and Financial Condition, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 6, 2021 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware (State or other jurisdiction of incorporation) 81-5245912 (IRS Employer Identification No.) 55 Broad Street |
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| May 6, 2021 |
Provention Bio Reports First Quarter 2021 Financial Results and Provides Business Update Exhibit 99.1 Provention Bio Reports First Quarter 2021 Financial Results and Provides Business Update RED BANK, N.J., May 6, 2021 - Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today reported financial results and provided a business update for the first quarter ended March 31, 2021. ?The first quarter of 2021 ma |
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| April 27, 2021 |
Exhibit 99.1 Provention Bio Provides Additional Regulatory Update on Biologics License Application for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-Risk Individuals RED BANK, N.J., April 27, 2021 ? Provention Bio, Inc., (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced the Company took part in a |
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| April 27, 2021 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 27, 2021 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware (State or other jurisdiction of incorporation) 81-5245912 (IRS Employer Identification No.) 55 Broad Str |
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| April 19, 2021 |
SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 4)* Provention Bio, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 74374N 102 (CUSIP Number) April 9, 2021 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designa |
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| April 19, 2021 |
EXHIBIT 1 AGREEMENT The persons below hereby agree that the Schedule 13G to which this agreement is attached as an exhibit, as well as all future amendments to such Schedule 13G, shall be filed on behalf of each of them. |
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| April 8, 2021 |
Regulation FD Disclosure, Other Events, Other Events, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 8, 2021 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction (IRS Employer of incorporation) Identification No.) 55 Broad Stre |
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| April 8, 2021 |
Exhibit 99.1 Provention Bio Provides Regulatory Update on Biologics License Application for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-Risk Individuals -Conference call and webcast to be held today at 5:00 p.m. Eastern Time - RED BANK, N.J., April 8, 2021 — Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune |
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| March 29, 2021 |
United States Securities and Exchange Commission Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant [X] Filed by a Party other than the Registrant [ ] Check the appropriate box: [ ] Preliminary Proxy Statement [ ] Confidential, For Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) [X] Definitive P |
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| March 29, 2021 |
United States Securities and Exchange Commission Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant [X] Filed by a Party other than the Registrant [ ] Check the appropriate box: [ ] Preliminary Proxy Statement [ ] Confidential, For Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) [ ] Definitive P |
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| March 19, 2021 |
United States Securities and Exchange Commission Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant [X] Filed by a Party other than the Registrant [ ] Check the appropriate box: [X] Preliminary Proxy Statement [ ] Confidential, For Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) [ ] Definitive P |
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| February 26, 2021 |
As filed with the Securities and Exchange Commission on February 26, 2021 Registration No. |
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| February 26, 2021 |
Exhibit 1.1 Provention Bio, Inc. Shares of Common Stock ($0.0001 par value per share) SALES AGREEMENT February 26, 2021 SVB LEERINK LLC One Federal Street, 37th Floor Boston, Massachusetts 02110 CANTOR FITZGERALD & CO. 499 Park Avenue New York, New York 10022 Ladies and Gentlemen: Provention Bio, Inc., a Delaware corporation (the ?Company?), confirms its agreement (this ?Agreement?) with SVB Leeri |
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| February 26, 2021 |
Calculation of Registration Fee As Filed Pursuant to Rule 424(b)(5) Registration No. 333-252045 Calculation of Registration Fee Title of each class of securities to be registered Proposed maximum aggregate offering price(1) Amount of registration fee(2) Common Stock, $0.0001 par value per share $ 150,000,000 $ 16,365 (1) The proposed maximum aggregate offering price is being used to calculate the registration fee pursuant to Rul |
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| February 26, 2021 |
Other Events, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 26, 2021 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction (IRS Employer of incorporation) Identification No.) 55 Broad |
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| February 25, 2021 |
Description of Registrant’s Securities. Exhibit 4.4 DESCRIPTION OF THE REGISTRANT?S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 As of February 25, 2021, Provention Bio, Inc. (the ?Company?) had one class of common stock registered under Section 12 of the Securities Exchange Act of 1934, as amended (the ?Exchange Act?). The following description of the Company?s common stock is a summary and does n |
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| February 25, 2021 |
Exhibit 99.1 Provention Bio Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update -U.S. Food and Drug Administration (FDA) filing of a Biologics License Application (BLA) and Priority Review for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals; PDUFA goal date of July 2, 2021- RED BANK, N.J., Feb. 25, 2021 /PRNewswire/ — P |
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| February 25, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ? ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2020 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO . Commission file number 001-38552 PROVENTION BIO, INC. (Ex |
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| February 25, 2021 |
Results of Operations and Financial Condition, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 25, 2021 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware (State or other jurisdiction of incorporation) 81-5245912 (IRS Employer Identification No.) 55 Broad |
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| February 16, 2021 |
SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 3)* Provention Bio, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 74374N 102 (CUSIP Number) December 31, 2020 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to des |
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| February 16, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. |
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| February 16, 2021 |
EX-99.1 2 d224777dex991.htm EX-1 EXHIBIT 1 AGREEMENT The persons below hereby agree that the Schedule 13G to which this agreement is attached as an exhibit, as well as all future amendments to such Schedule 13G, shall be filed on behalf of each of them. This agreement is intended to satisfy the requirements of Rule 13d-1(k)(1)(iii) under the Securities Exchange Act of 1934. Date: February 16, 2021 |
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| February 5, 2021 |
SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* Provention Bio, Inc. (Name of Issuer) Common Stock, $0.0001 par value per share (Title of Class of Securities) 74374N 102 (CUSIP Number) December 31, 2020 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to desig |
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| January 15, 2021 |
Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits - UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 13, 2021 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware (State or other jurisdiction of incorporation) 81-5245912 (IRS Employer Identification No.) 55 Broad S |
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| January 15, 2021 |
Calculation of Registration Fee Calculation of Registration Fee Title of each class of securities to be registered Amount to be registered Proposed maximum offering price per unit Proposed maximum aggregate offering price Amount of registration fee(1) Common Stock, $0. |
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| January 15, 2021 |
PART II INFORMATION NOT REQUIRED IN PROSPECTUS Exhibit 99.1 PART II INFORMATION NOT REQUIRED IN PROSPECTUS Item 14. Other Expenses of Issuance and Distribution. The following table sets forth estimates of the various expenses, other than any underwriting discounts and commissions, in connection with the sale and distribution of the securities being registered. Securities and Exchange Commission Registration Fee $ 12,546 Printing and related ex |
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| January 15, 2021 |
Exhibit 1.1 EXECUTION VERSION Provention Bio, Inc. (a Delaware corporation) 6,250,000 Shares of Common Stock UNDERWRITING AGREEMENT January 13, 2021 SVB Leerink LLC Cantor Fitzgerald & Co. as Representatives of the several Underwriters c/o SVB Leerink LLC One Federal Street, 37th Floor Boston, MA 02110 c/o Cantor Fitzgerald & Co. 499 Park Avenue New York, New York 10022 Ladies and Gentlemen: Prove |
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| January 12, 2021 |
Results of Operations and Financial Condition - UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 12, 2021 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware (State or other jurisdiction of incorporation) 81-5245912 (IRS Employer Identification No.) 55 Broad S |
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| January 12, 2021 |
As filed with the Securities and Exchange Commission on January 12, 2021 Registration No. |
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| January 12, 2021 |
SUBJECT TO COMPLETION, DATED JANUARY 12, 2021 Filed Pursuant to Rule 424(b)(5) Registration No. 333-252045 The information contained in this preliminary prospectus supplement is not complete and may be changed. A registration statement relating to these securities has become effective by rule of the Securities and Exchange Commission. This preliminary prospectus supplement and the accompanying prospectus are not an offer to sell these securit |
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| November 5, 2020 |
As filed with the Securities and Exchange Commission on November 5, 2020 Registration No. |
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| November 5, 2020 |
Provention Bio Reports Third Quarter 2020 Financial Results and Provides Business Update Exhibit 99.1 Provention Bio Reports Third Quarter 2020 Financial Results and Provides Business Update - Completed rolling submission of the Biologics License Application (BLA) for teplizumab in the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals - - Launched two closely-aligned national T1D early-stage disease and screening education campaigns - RED BANK, N.J., Novembe |
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| November 5, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-38552 PROVENTION BI |
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| November 5, 2020 |
Results of Operations and Financial Condition, Financial Statements and Exhibits - UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (date of earliest event reported): November 5, 2020 PROVENTION BIO, INC. (Exact name of registrant as specified in its charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Commission F |
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| October 30, 2020 |
provention bio, INC. 2020 INDUCEMENT PLAN ADOPTED: October 29, 2020 provention bio, INC. 2020 INDUCEMENT PLAN ADOPTED: October 29, 2020 1. GENERAL. (a) Eligible Award Recipients. Awards under the Plan may only be granted to an individual not previously an Employee or Director of the Company, or to an individual following a bona fide period of non-employment with the Company, as an inducement material to the individual’s entering into employment with the Company wi |
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| October 30, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 29, 2020 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware (State or other jurisdiction of incorporation) 81-5245912 (IRS Employer Identification No.) P.O. Box 6 |
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| August 11, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 10, 2020 PROVENTION BIO, INC. Commission File Number: 001-38552 Delaware 81-5245912 (State or other jurisdiction of incorporation) (IRS Employer Identification No.) P.O. Box 66 |
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| August 11, 2020 |
Exhibit 99.1 John K. Jenkins, MD Joins Provention Bio Board of Directors -Former Director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research, brings extensive regulatory expertise and experience to Provention- OLDWICK, N.J., August 11, 2020 /PRNewswire/ — Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-me |
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| August 6, 2020 |
Results of Operations and Financial Condition, Financial Statements and Exhibits 8-K 1 form8-k.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (date of earliest event reported): August 6, 2020 PROVENTION BIO, INC. (Exact name of registrant as specified in its charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporatio |
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| August 6, 2020 |
Exhibit 10.1 Execution Copy EMPLOYMENT AGREEMENT This EMPLOYMENT AGREEMENT (this “Agreement”), effective August 3, 2020 (the “Effective Date”), is by and between PROVENTION BIO, INC., a Delaware corporation (the “Company”) and Heidy Abreu King-Jones, Esq. (the “Executive”). W I T N E S S E T H WHEREAS, the Company desires to employ the Executive as its Chief Legal Officer, and the Executive desire |
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| August 6, 2020 |
Provention Bio Reports Second Quarter 2020 Financial Results and Provides Business Update Exhibit 99.1 Provention Bio Reports Second Quarter 2020 Financial Results and Provides Business Update - Completed commercial-scale drug substance PPQ campaign ahead of schedule, enabling the expected on-time completion of the rolling Biologics License Application (BLA) submission for teplizumab in Q4 2020 - - Expect to submit clinical module of rolling BLA for teplizumab in Q3 2020 - - Extended f |
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| August 6, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q/A (Amendment No. 1) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001 |
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| August 6, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K/A (Amendment No. 2) [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2019 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO . Commission file number 001-38552 |
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| August 6, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-38552 PROVENTION BIO, IN |
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| August 6, 2020 |
Steven M. Skolnick Partner One Lowenstein Drive Roseland, New Jersey 07068 + T: 973 597 2476 F: 973 597 2477 E: [email protected] August 6, 2020 Division of Corporation Finance Office of Life Sciences United States Securities and Exchange Commission Mail Stop 3030 Washington, DC 20549 Attention: Frank Wyman Re: Provention Bio, Inc. Form 10-K for the fiscal year ended December 31, 2019 Filed |
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| July 16, 2020 |
Submission of Matters to a Vote of Security Holders UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (date of earliest event reported): July 15, 2020 PROVENTION BIO, INC. (Exact name of registrant as specified in its charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Commission File |
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| June 30, 2020 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (date of earliest event reported): June 30, 2020 PROVENTION BIO, INC. (Exact name of registrant as specified in its charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Commission File |
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| June 30, 2020 |
United States Securities and Exchange Commission Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant [X] Filed by a Party other than the Registrant [ ] Check the appropriate box: [ ] Preliminary Proxy Statement [ ] Confidential, For Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) [ ] Definitive P |
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| June 30, 2020 |
Exhibit 99.1 Provention Bio Announces Change to a Virtual Meeting Format for the 2020 Annual Meeting of the Stockholders OLDWICK, NJ, June 30, 2020 /PRNewswire/ – Provention Bio, Inc., (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, announced today a change in the format of its 2020 Annual Meeting of Stockholders (the “Annual Meeting”) |
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| June 18, 2020 |
Filed Pursuant to Rule 424(b)(5) Registration Nos. 333-232995 and 333-239246 PROSPECTUS SUPPLEMENT (To Prospectus dated August 8, 2019) 6,600,000 Shares Common Stock We are offering 6,600,000 shares of our common stock. Our common stock is listed on the Nasdaq Global Select Market under the symbol “PRVB.” On June 17, 2020, the last reported sale price of our common stock as reported on the Nasdaq |
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| June 18, 2020 |
Provention Bio Announces Proposed Public Offering of Common Stock Exhibit 99.1 Provention Bio Announces Proposed Public Offering of Common Stock OLDWICK, N.J., June 16, 2020 – Provention Bio, Inc., (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that it has commenced an underwritten public offering of 5,500,000 shares of its common stock. All of the shares to be sold in the offering a |
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| June 18, 2020 |
Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (date of earliest event reported): June 17, 2020 PROVENTION BIO, INC. (Exact name of registrant as specified in its charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Commission File |
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| June 18, 2020 |
Exhibit 1.1 Provention Bio, Inc. (a Delaware corporation) 6,600,000 Shares of Common Stock UNDERWRITING AGREEMENT June 17, 2020 SVB Leerink LLC Cantor Fitzgerald & Co. as Representatives of the several Underwriters c/o SVB Leerink LLC One Federal Street, 37th Floor Boston, MA 02110 c/o Cantor Fitzgerald & Co. 499 Park Avenue New York, New York 10022 Ladies and Gentlemen: Provention Bio, Inc., a De |
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| June 18, 2020 |
Filed Pursuant to Rule 424(b)(5) Registration Nos. 333-232995 and 333-239246 PROSPECTUS SUPPLEMENT (To Prospectus dated August 8, 2019) 6,600,000 Shares Common Stock We are offering 6,600,000 shares of our common stock. Our common stock is listed on the Nasdaq Global Select Market under the symbol “PRVB.” On June 17, 2020, the last reported sale price of our common stock as reported on the Nasdaq |
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| June 18, 2020 |
Provention Bio Announces Pricing of $95.7 Million Public Offering of Common Stock Exhibit 99.2 Provention Bio Announces Pricing of $95.7 Million Public Offering of Common Stock OLDWICK, NJ, June 17, 2020 – Provention Bio, Inc., (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced the pricing of its previously announced underwritten public offering of 6,600,000 shares of its common stock at a public offeri |
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| June 17, 2020 |
Subject to completion, dated June 16, 2020 The information contained in this preliminary prospectus supplement and the accompanying prospectus is not complete and may be changed. |
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| June 17, 2020 |
As filed with the Securities and Exchange Commission on June 17, 2020 Registration Statement No. |
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| June 15, 2020 |
Exhibit 99.1 Provention Bio’s Teplizumab Continued to Significantly Delay the Onset of Insulin-Dependent Type 1 Diabetes (T1D) in Presymptomatic Patients -One Course of Teplizumab Now Shown to Delay Insulin-Dependent T1D by a Median of Approximately Three Years Compared to Placebo- -Teplizumab Significantly Reversed the Decline in C-Peptide Levels Providing Further Evidence of Disease-Modifying Ef |
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| June 15, 2020 |
Financial Statements and Exhibits, Regulation FD Disclosure, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (date of earliest event reported): June 15, 2020 PROVENTION BIO, INC. (Exact name of registrant as specified in its charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Commission File |
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| June 15, 2020 |
Exhibit 99.2 |
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| June 11, 2020 |
Exhibit 10.4 FIRST AMENDED EMPLOYMENT AGREEMENT This EMPLOYMENT AGREEMENT (this “Agreement”), effective June 9, 2020 (the “Effective Date”), is by and between PROVENTION BIO, INC., a Delaware corporation (the “Company”) and Eleanor Ramos (the “Executive”). W I T N E S S E T H WHEREAS, the Company and the Executive are party to that certain Employment Agreement dated as of June 20, 2017, which sets |
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| June 11, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (date of earliest event reported): June 9, 2020 PROVENTION BIO, INC. (Exact name of registrant as specified in its charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Commission File |
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| June 11, 2020 |
Exhibit 10.1 FIRST AMENDED EMPLOYMENT AGREEMENT This EMPLOYMENT AGREEMENT (this “Agreement”), effective June 9, 2020 (the “Effective Date”), is by and between PROVENTION BIO, INC., a Delaware corporation (the “Company”) and Andrew Drechsler (the “Executive”). WITNESSETH WHEREAS, the Company and the Executive are party to that certain Employment Agreement dated as of September 21, 2017, which sets |
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| June 11, 2020 |
Exhibit 10.2 FIRST AMENDED EMPLOYMENT AGREEMENT This EMPLOYMENT AGREEMENT (this “Agreement”), effective June 9, 2020 (the “Effective Date”), is by and between PROVENTION BIO, INC., a Delaware corporation (the “Company”) and Jason Hoitt (the “Executive”). W I T N E S S E T H WHEREAS, the Company and the Executive are party to that certain Employment Agreement dated as of January 7, 2020, which sets |
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| June 11, 2020 |
Exhibit 10.3 FIRST AMENDED EMPLOYMENT AGREEMENT This EMPLOYMENT AGREEMENT (this “Agreement”), effective June 10, 2020 (the “Effective Date”), is by and between PROVENTION BIO, INC., a Delaware corporation (the “Company”) and Francisco Leon (the “Executive”). W I T N E S S E T H WHEREAS, the Company and the Executive are party to that certain Employment Agreement dated as of April 25, 2017, which s |
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| June 4, 2020 |
United States Securities and Exchange Commission Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant [X] Filed by a Party other than the Registrant [ ] Check the appropriate box: [ ] Preliminary Proxy Statement [ ] Confidential, For Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) [X] Definitive P |
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| June 4, 2020 |
United States Securities and Exchange Commission Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant [X] Filed by a Party other than the Registrant [ ] Check the appropriate box: [ ] Preliminary Proxy Statement [ ] Confidential, For Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) [ ] Definitive P |
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| May 20, 2020 |
Exhibit 3.1 AMENDED AND RESTATED BYLAWS OF PROVENTION BIO, INC. (a Delaware corporation) TABLE OF CONTENTS PAGES ARTICLE I CORPORATE OFFICES 1 1.1 REGISTERED OFFICE 1 1.2 OTHER OFFICES 1 ARTICLE II MEETINGS OF STOCKHOLDERS 1 2.1 PLACE OF MEETINGS 1 2.2 ANNUAL MEETING 1 2.3 SPECIAL MEETING 1 2.4 ADVANCE NOTICE PROCEDURES 1 2.5 NOTICE OF STOCKHOLDERS’ MEETINGS 5 2.6 QUORUM 6 2.7 ADJOURNED MEETING; N |
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| May 20, 2020 |
Exhibit 10.1 FIRST AMENDED EMPLOYMENT AGREEMENT This FIRST AMENDED EMPLOYMENT AGREEMENT (this “Agreement”), dated May 19, 2020 (the “Effective Date”), is by and between PROVENTION BIO, Inc., a Delaware corporation (the “Company”) and ASHLEIGH PALMER (the “Executive”). W I T N E S S E T H: WHEREAS, the Company desires to continue to employ the Executive as its President and Chief Executive Officer |
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| May 20, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (date of earliest event reported): May 15, 2020 PROVENTION BIO, INC. (Exact name of registrant as specified in its charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Commission File |
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| May 20, 2020 |
Provention Bio Announces Changes to its Board of Directors Exhibit 99.1 Provention Bio Announces Changes to its Board of Directors - Nancy Wysenski, a Seasoned Pharmaceutical Executive with Rare Disease and Commercialization Experience, Appointed as a New Director- - Anthony DiGiandomenico Steps Down as a Director After Three Years of Service- OLDWICK, N.J., May 20, 2020 /PRNewswire/ — Provention Bio, Inc. (Nasdaq: PRVB), a clinical-stage biopharmaceutica |
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| May 7, 2020 |
Exhibit 99.1 Provention Bio Reports First Quarter 2020 Financial Results and Provides Business Update - Company on Track to Complete Submission of Rolling Biologics License Application for Teplizumab in Q4 2020 - OLDWICK, N.J., May 7, 2020 /PRNewswire/ — Provention Bio, Inc. (Nasdaq: PRVB), a clinical-stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases |
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| May 7, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-38552 PROVENTION BI |
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| May 7, 2020 |
Results of Operations and Financial Condition, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (date of earliest event reported): May 7, 2020 PROVENTION BIO, INC. (Exact name of registrant as specified in its charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Commission File N |
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| April 8, 2020 |
PRVB / Provention Bio, Inc. 10-K/A - Annual Report - UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K/A (Amendment No. 1) [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2019 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO . Commission file number 001-38552 |
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| March 12, 2020 |
PRVB / Provention Bio, Inc. S-8 - - As filed with the Securities and Exchange Commission on March 12, 2020 Registration No. |
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| March 12, 2020 |
Results of Operations and Financial Condition, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (date of earliest event reported): March 12, 2020 PROVENTION BIO, INC. (Exact name of registrant as specified in its charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Commission Fil |
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| March 12, 2020 |
Exhibit 99.1 Provention Bio Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update -Expect to Complete Submission of a BLA for PRV-031 (Teplizumab) in Q4 2020 -Positive Phase 1b PREVAIL Study for PRV-3279 Announced Today -Conference Call and Live Audio Webcast Scheduled for Today at 8:30 a.m. ET OLDWICK, N.J., March 12, 2020 /PRNewswire/ — Provention Bio, Inc. (Na |
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| March 12, 2020 |
Description of Registrant’s Securities (filed herewith, Exhibit 4.4). Exhibit 4.4 DESCRIPTION OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 As of March 12, 2020, Provention Bio, Inc. had one class of common stock registered under Section 12 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The following description of our common stock is a summary and does not purport to be complete. It |
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| March 12, 2020 |
PRVB / Provention Bio, Inc. 10-K - Annual Report - UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2019 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO . Commission file number 001-38552 PROVENTION BIO, INC. |
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| February 20, 2020 |
PRVB / Provention Bio, Inc. / Macrogenics Inc - SC 13G/A Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* Provention Bio, Inc. (Name of Issuer) Common Stock, $0.0001 par value (Title of Class of Securities) 74374N102 (CUSIP Number) December 31, 2019 (Date of Event which Requires Filing of this Statement) Check the appropriate box to designate the rule pursua |
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| February 18, 2020 |
PRVB / Provention Bio, Inc. / PERCEPTIVE ADVISORS LLC - SC 13G/A Passive Investment SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 2)* Provention Bio, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 74374N 102 (CUSIP Number) December 31, 2019 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to des |
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| February 14, 2020 |
PRVB / Provention Bio, Inc. / PERCEPTIVE ADVISORS LLC - SC 13G/A Passive Investment SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 1)* Provention Bio, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 74374N 102 (CUSIP Number) December 31, 2019 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to des |
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| February 14, 2020 |
PRVB / Provention Bio, Inc. / Vactech Oy Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. |
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| February 14, 2020 |
EX-99.1 EXHIBIT 1 AGREEMENT The persons below hereby agree that the Schedule 13G to which this agreement is attached as an exhibit, as well as all future amendments to such Schedule 13G, shall be filed on behalf of each of them. This agreement is intended to satisfy the requirements of Rule 13d-1(k)(1)(iii) under the Securities Exchange Act of 1934. Date: February 14, 2020 PERCEPTIVE ADVISORS LLC |
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| February 14, 2020 |
PRVB / Provention Bio, Inc. / Palmer Ashleigh Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. |
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| February 14, 2020 |
PRVB / Provention Bio, Inc. / Leon Francisco Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. |
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| January 17, 2020 |
SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b),(c) AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2(b) (Amendment No. 1)1 Provention Bio, Inc. (Name of Issuer) Common Stock, $0.0001 par value (Title of Class of Securities) 74374N102 (CUSIP Number) December 31, 2019 (Date of E |
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| January 8, 2020 |
Other Events, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (date of earliest event reported): January 7, 2020 PROVENTION BIO, INC. (Exact name of registrant as specified in its charter) Delaware 001-38552 81-5245912 (State or Other Jurisdiction of Incorporation) (Commission Fi |
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| January 8, 2020 |
EX-10.1 2 ex10-1.htm EMPLOYMENT AGREEMENT This EMPLOYMENT AGREEMENT (this “Agreement”), effective January 7, 2020 (the “Effective Date”), is by and between PROVENTION BIO, INC., a Delaware corporation (the “Company”) and Jason Hoitt (the “Executive”). W I T N E S S E T H WHEREAS, the Company desires to employ the Executive as its Chief Commercial Officer, and the Executive desires to accept such e |
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| January 8, 2020 |
Provention Bio Appoints Jason Hoitt as Chief Commercial Officer Provention Bio Appoints Jason Hoitt as Chief Commercial Officer OLDWICK, N.J., Jan. 8, 2019 /PRNewswire/ — Provention Bio, Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced the appointment of Jason Hoitt as Chief Commercial Officer. Mr. Hoitt brings 18 years of commercial experience in the biotechnolog |
