# EDGAR Filing Document

**Accession Number:** 0001695357
**File Stem:** 0001493152-23-000613
**Filing Date:** 2023-1
**Character Count:** 16600
**Document Hash:** 1656321233885cee59ece6d9a34a808e
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-23-000613.hdr.sgml**: 20230105

**ACCESSION NUMBER**: 0001493152-23-000613

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230103

**ITEM INFORMATION**: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230105

**DATE AS OF CHANGE**: 20230105

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Provention Bio, Inc.
- **CENTRAL INDEX KEY:** 0001695357
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38552
- **FILM NUMBER:** 23511676

**BUSINESS ADDRESS:**
- **STREET 1:** 55 BROAD STREET, 2ND FLOOR
- **CITY:** RED BANK
- **STATE:** NJ
- **ZIP:** 07701
- **BUSINESS PHONE:** 908-428-9136

**MAIL ADDRESS:**
- **STREET 1:** 55 BROAD STREET, 2ND FLOOR
- **CITY:** RED BANK
- **STATE:** NJ
- **ZIP:** 07701

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Provention Inc.
- **DATE OF NAME CHANGE:** 20170120

?xml version="1.0" encoding="utf-8"?

**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 Street, 2nd Floor** |  |
| **Red Bank, New Jersey** | **07701** |
| (Address of principal executive offices) | (Zip Code) |

---

**(908) 336-0360**

(Registrant's telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| Title of each class | Trading Symbol | Name of each exchange on which registered |
| **Common Stock, $0.0001 par value per share** | **PRVB** | **The Nasdaq Global Select Market** |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

**Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.**

Effective January 3, 2023, the Board of Directors (the "Board") of Provention Bio, Inc. (the "Company") increased the size of the Board to six directors and appointed Rita Jain, age 60, to fill the newly created directorship. Dr. Jain will hold this position until the next annual meeting of the Company's shareholders or until her successor is elected and qualified, subject to her earlier resignation or removal.

Dr. Jain, a board-certified rheumatologist, has served as a member of the Supervisory Board of AM-Pharma B.V. since 2020 and on the Board of Directors of ChemoCentryx, Inc. from 2019 until its acquisition by Amgen in 2022. Additionally, from 2021 to 2022, Dr. Jain served as Executive Vice President, Chief Medical Officer of ChemoCentryx, Inc. and in 2021 served as Chief Medical Officer of Immunovant, Inc. From 2017 to 2019, Dr. Jain was Senior Vice President and Chief Medical Officer at Akebia Therapeutics, Inc. From 2013 to 2016, Dr. Jain was Vice President of Men's and Women's Health and Metabolic Development at AbbVie Inc. Dr. Jain also held various leadership roles at Abbott Laboratories from 2003 through 2012, including as Divisional Vice President of Pain, Respiratory and Metabolic Disease Development. Dr. Jain received her B.S. degree in biology from the Long Island University, and her M.D. from the State University of New York at Stony Brook School of Medicine.

In accordance with the Company's non-employee director compensation policy, Dr. Jain will receive an annual cash retainer fee of $40,000. Dr. Jain will also receive an initial option grant to purchase 66,000 shares of the Company's common stock upon commencement of her position as director.

The Company will enter into an indemnification agreement with Dr. Jain (the "Indemnification Agreement"), in the Company's standard form which has been previously entered into by the Company with each of the Company's directors and executive officers, the form of which was filed as Exhibit 10.2 to the Company's Registration Statement on Form S-1 filed with the Securities and Exchange Commission on May 9, 2018.

Additionally, the Company appointed Justin Vogel to serve as the Company's Chief Accounting Officer, effective January 3, 2023. Mr. Vogel, age 51, has served as the Company's Senior Vice President and Controller since September 2018. Mr. Vogel joined the Company from Aralez Pharmaceuticals Inc. ("Aralez"), where he served as Senior Director of External Reporting and Technical Accounting from March 2017 to September 2018. Prior to his time at Aralez, Mr. Vogel served as Executive Director of Finance and Accounting at Iveric Bio, Inc. (formerly known as Ophthotech Corporation) from October 2013 to March 2017.

Mr. Vogel's employment with the Company is governed by an employment agreement. Reporting to the Chief Financial Officer, Mr. Vogel's current compensation under the agreement includes an annual salary of $375,000, with annual review and adjustment at the discretion of the Company, and an annual bonus of 35% of annual salary based on the achievement of the Company's corporate objectives and Mr. Vogel's individual objectives, in each case established by the Company.

Mr. Vogel's employment agreement may be terminated by the Company without cause or by Mr. Vogel for good reason, in which case Mr. Vogel would be entitled severance in the amount of nine months of base salary in effect at the time of termination, payment of COBRA premiums for nine months, possible pro rata payment of his annual bonus and accelerated vesting for equity awards that would have vested within nine months of the termination date; *provided that*, in the event of a termination by the Company without cause or by Mr. Vogel for good reason within 12 months following a change in control of the Company, Mr. Vogel will be entitled to severance in the amount of 12 months of base salary in effect at the time of termination, payment of COBRA premiums for 12 months, possible pro rata portion of his annual bonus and accelerated vesting of equity awards. Mr. Vogel is also bound by customary confidentiality and assignment of inventions provisions.

**Item 7.01. Regulation FD.**

On January 5, 2023, the Company issued a press release announcing the appointment of Dr. Jain to its Board of Directors. A copy of the press release is furnished as Exhibit 99.1 hereto and shall not be deemed "filed" for the purpose of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

**Item 9.01 Financial Statements and Exhibits.**

(d) The following exhibit is furnished with this report:

---

| | |
|:---|:---|
| Exhibit No. | Description |
| 99.1 | [Press Release issued by Provention Bio on January 5, 2023](ex99-1.htm) |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL) |

---

**SIGNATURE**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: January 5, 2023

---

| | |
|:---|:---|
| **Provention Bio, Inc.** | **Provention Bio, Inc.** |
| By: | */s/ Thierry Chauche* |
|  | Thierry Chauche |
|  | Chief Financial Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

**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 biotechnology industry veteran with more than two decades of experience in pharmaceutical development across her time with ChemoCentryx, Inc., AbbVie, Abbott Laboratories, and G.D. Searle and Co. prior to the latter's merger with Pharmacia & Upjohn and subsequent acquisition by Pfizer.

"Rita brings extensive drug development experience to Provention Bio across a wide range of therapeutic areas including autoimmune and metabolic diseases," said Wayne Pisano, Chairman of the Board of Provention Bio. "Rita's demonstrated track record in leading corporate strategy formulation and the execution of global, commercial programs makes her a strong addition as we look to expand the experience of our Board to support this new, exciting chapter in the Company's evolution. We look forward to Rita's governance, advice and counsel as we advance the commercial launch of TZIELD™ (teplizumab-mzwv) in the U.S. and move towards the establishment of a global franchise."

"The FDA approval and U.S. commercial launch of TZIELD™ is a paradigm-shifting moment for people who may develop type 1 diabetes and I am truly excited to be a part of this journey," said Dr. Jain. "It is an honor to join Provention's Board and partner with the leadership team in support of the Company's mission to intercept and prevent life-threatening and debilitating autoimmune diseases."

Dr. Jain, a board-certified rheumatologist, currently serves as a member of the supervisory board of AM Pharma and previously served on the Board of Directors of ChemoCentryx, Inc. until its acquisition by Amgen. She previously served as Executive Vice President, Chief Medical Officer of ChemoCentryx, Inc., Chief Medical Officer of Immunovant, Inc. and prior to that, Senior Vice President and Chief Medical Officer of Akebia Therapeutics, Inc. Before joining Akebia, Dr. Jain served as Vice President of Men's and Women's Health and Metabolic Development at AbbVie, Inc., where she was responsible for leading the design and execution of multiple late-stage programs, including for Orilissa® and Oriahnn®, and in various leadership roles at Abbott Laboratories, including Divisional Vice President. She has also led programs across a diverse set of therapeutic areas, including inflammation, pain, immunology, and nephrology. Prior to her time at Abbott, she held management positions in the Arthritis, Inflammation and Pain Group at G.D. Searle, which was acquired by Pharmacia and, later, Pfizer. Earlier in her career, Dr. Jain served as a faculty member at North Shore University Hospital in New York. Dr. Jain received her M.D. from the State University of New York at Stony Brook School of Medicine and her B.S. in Biology from Long Island University/C.W. Post.

**About Provention Bio, Inc.**

Provention Bio, Inc. (Nasdaq: PRVB) is a commercial-stage biopharmaceutical company focused on advancing the development and commercialization of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated diseases. The Company's pipeline includes clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in autoimmune diseases, including T1D, celiac disease and lupus. Visit <u>www.proventionbio.com</u> for more information and follow us on Twitter: @ProventionBio.

![](ex99-1_001.jpg)

**Internet Posting of Information:**

Provention Bio, Inc. uses its website, <u>www.proventionbio.com</u>, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation F.D. Such disclosures will be included on the Company's website in the "News" section. Accordingly, investors should monitor this portion of the Company's website, in addition to following its press releases, SEC filings and public conference calls and webcasts.

**Forward-Looking Statements**

Certain statements in this press release are forward-looking, including but not limited to, statements relating to the contributions of the Company's new director and the commercial launch of TZIELD™. These statements may be identified by the use of forward-looking words and phrases such as "look forward" and "advance" among others. These forward-looking statements are based on the Company's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, failure to maintain FDA approval for TZIELD™; the planned commercial launch in the US for TZIELD™ may not be successful in part or at all for various reasons including the actual market size and drug supply needed may not be consistent with the company's expectations and its executed commercial readiness plans; the degree to which TZIELD™ is accepted by patients and prescribed by physicians; the efficiency of our manufacturing, sales, distribution and specialty pharmacy network in getting TZIELD™ to the market and future economic, competitive, reimbursement and regulatory conditions that could negatively impact the commercial launch of TZIELD™; the post-marketing commitment studies for TZIELD™ may not yield data consistent with prior results; we may not be able to execute on our business plans including meeting our expected or planned regulatory milestones and timelines, clinical development plans and successfully bringing our product candidates to market, for various reasons, including factors outside of the Company's control, such as possible limitations of Company financial and other resources, competition, manufacturing limitations that may not be anticipated or resolved for in a timely manner or at all, and regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates, the potential for noncompliance with FDA regulations; the potential impacts of COVID-19 on our business and financial results; changes in law, regulations, or interpretations and enforcement of regulatory guidance; uncertainties of patent protection and litigation; competition and the risks listed under "Risk Factors" in the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2022 and any subsequent filings with the Securities and Exchange Commission. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Provention does not undertake an obligation to update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. The information set forth herein speaks only as of the date hereof.

**Investor Contact:**

Kristen Kelleher, Manager, Investor Relations<br> <u>investorrelations@proventionbio.com</u>

**Media Contact:**

Kaelan Hollon, VP, Corporate Communications<br> <u>khollon@proventionbio.com</u><br> 202-421-4921