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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
Number) |
|
(IRS
Employer
Identification
No.) |
55
Broad Street, 2nd Floor
Red
Bank, NJ |
|
07701 |
| (Address
of Principal Executive Offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (908) 336-0360
Not
Applicable
(Former
Name or Former Address, if Changed Since Last Report)
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(s) |
|
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
1.01 Entry into a Material Definitive Agreement.
Co-Promotion
Agreement
On
October 4, 2022, the Company and Genzyme Corporation, a fully-owned subsidiary of Sanofi (“Sanofi”) entered into a Co-Promotion
Agreement (the “Sanofi Co-Promotion Agreement”). Pursuant to the Sanofi Co-Promotion Agreement, the Company appointed Sanofi
to co-promote and conduct certain commercialization activities with respect to teplizumab in the United States on a co-exclusive basis
for the treatment of the indication for which teplizumab receives approval in the United States during the term of the Sanofi Co-Promotion
Agreement. Under the Sanofi Co-Promotion Agreement, Sanofi commits to making field resources representing more than 100 FTEs available
for such co-promotion and commercialization activities if teplizumab is approved in the United States by a certain date.
Pursuant
to the Sanofi Co-Promotion Agreement, the Company commits to reimburse the field force-related expenses and certain other allowable expenses
that Sanofi will incur in connection with commercializing teplizumab under the agreement, up to an aggregate cap of $33 million, which
includes a pre-determined margin on field force-related expenses.
Pursuant
to the Sanofi Co-Promotion Agreement, the Company also granted Sanofi an exclusive, one-time right of first negotiation to obtain exclusive
rights to research, develop and commercialize teplizumab with respect to the treatment or delay of Type 1 diabetes, or any of its root
causes throughout the world, and to manufacture teplizumab in support of such research, development and commercialization (the “ROFN”)
in exchange for a one-time upfront payment of $20 million, and subject to certain retained rights of the Company to engage in discussions
with third parties with respect to certain transactions (“Third Party Transactions”). Sanofi may exercise the ROFN beginning
on October 4, 2022 until June 30, 2023 (the “Initial ROFN Period”), and the Initial ROFN Period may be extended (a) at Sanofi’s
election, upon payment of a one-time extension fee, to the later of (i) September 30, 2023, and (ii) 60 days after the Company delivers
to Sanofi the top-line data for an identified clinical trial sponsored by the Company (the “Data Delivery Date”); or (b)
automatically, without an extension fee, to 60 days after the Data Delivery Date if the Company does not receive regulatory approval
for teplizumab before November 30, 2022. Within six months following the later of the expiration of (x) the Initial ROFN Period, and
(y) any extension to the Initial ROFN Period pursuant to the terms of the Sanofi Co-Promotion Agreement, the Company may not enter into
a Third Party Transaction on terms that are materially less favorable in the aggregate to the Company than the most recent terms Sanofi
offered, if any, without first permitting Sanofi to execute an agreement with the Company on either such terms previously offered by
Sanofi or the terms offered by such third party.
The
activities of the Company and Sanofi under the Sanofi Co-Promotion Agreement in the United States will be overseen by a joint steering
committee composed of representatives from the Company and Sanofi. Under the Sanofi Co-Promotion Agreement, subject to any execution
of a definitive agreement following an exercise of the ROFN (as defined below), the Company will retain the right to develop, manufacture,
supply and distribute, as well as determine the commercialization strategy for, teplizumab and will remain responsible for the costs
of holding and maintaining regulatory approval of, reporting adverse events relating to, developing, manufacturing, supplying and distributing
teplizumab.
The
term of the Sanofi Co-Promotion Agreement expires on December 31, 2023. Subject to specified notice periods and limitations, (a) Sanofi
may terminate the Sanofi Co-Promotion Agreement early if regulatory approval for teplizumab either is not obtained in the U.S. by December
31, 2022 or is obtained but later withdrawn or the Company undergoes a change of control with a major biopharmaceutical company with
a certain level of financial resources and (b) either the Company or Sanofi may terminate the Sanofi Co-Promotion Agreement early if
(i) the other party commits an uncured material breach, (ii) the other party undergoes a bankruptcy event, (iii) there is a material
safety event associated with teplizumab, or (iv) there is a prolonged delay in performance due to a force majeure event.
Securities
Purchase Agreement
Simultaneously
with their entry into the Sanofi Co-Promotion Agreement, the Company and Sanofi also entered into a Securities Purchase Agreement (the
“Purchase Agreement”). Pursuant to the Purchase Agreement, if the Biologics License Application submitted to the United States
Food and Drug Administration (the “FDA”) for the delay of clinical type 1 diabetes in at-risk individuals is approved by
the FDA, Sanofi has agreed to purchase $35 million of the Company’s common stock, par value $0.0001 per share (the “Common
Stock”). The purchase price per share will equal 140% of the daily volume-weighted average per share price of the Common Stock
for the five consecutive trading days prior to the closing date. The closing date and five consecutive trading day period for determining
the purchase price per share shall be at the Company’s election, but the closing must occur no later than February 16, 2023.
Pursuant
to the Purchase Agreement, prior to June 30, 2023 (the “Lock-Up Period”) Sanofi will not, without the prior written consent
of the Company, directly or indirectly, (i) offer, pledge, sell, contract to sell, sell any shares of Common Stock, or otherwise dispose
of or transfer any Shares (collectively, the “Lock-Up Securities”) or (ii) enter into any swap or any other agreement or
any transaction that transfers, in whole or in part, directly or indirectly, the economic consequence of ownership of the Lock-Up Securities,
whether any such swap or transaction is to be settled by delivery of Common Stock or other securities, provided, that the foregoing shall
not prohibit (a) Sanofi from transferring any Lock-Up Securities to any of its affiliates or to the Company, (b) the disposition of any
Lock-Up Securities pursuant to (x) any merger, consolidation or similar transaction to which the Company is a constituent corporation
or (y) a bona fide tender offer or exchange offer made to all holders of Common Stock by a person other than the Sanofi or any of Sanofi’s
affiliates, or (c) Sanofi from transferring shares of Common Stock to reduce its ownership below 19.9% if the Common Stock owned by Sanofi
represents greater than 19.9% ownership of the then-outstanding shares of Common Stock solely as a result of an action taken by the Company.
The
Purchase Agreement also provides Sanofi with demand registration rights in respect of the shares of Common Stock issued pursuant to the
Purchase Agreement, subject to certain conditions. In addition, in the event that the Company registers additional shares of common stock
for sale to the public, the Company will be required to give notice of such registration to Sanofi, and, subject to certain limitations,
include Sanofi’s shares of Common Stock in such registration. The registration rights granted under the Purchase Agreement will
commence on June 30, 2023 and expire on June 30, 2025.
The
foregoing is a summary description of certain terms of the Sanofi Co-Promotion Agreement and the Purchase Agreement are not complete
and are qualified in its entirety by reference to the text of the Sanofi Co-Promotion Agreement and the Purchase Agreement, which the
Company expects to file as exhibits to the Company’s Annual Report on Form 10-K for the fiscal ending December 31, 2022.
Item
7.01 Regulation FD Disclosure.
On
October 6, 2022, the Company issued a press release announcing the entry into the Sanofi Co-Promotion Agreement and the Purchase Agreement.
A copy of the press release is furnished herewith as Exhibit 99.1 and incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits.
(d)
The following exhibit is furnished with this report:
SIGNATURES
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.
| |
Provention
Bio, Inc. |
| |
|
|
| Dated:
October 6, 2022 |
By: |
/s/
Thierry Chauche |
| |
|
Thierry
Chauche |
| |
|
Chief
Financial Officer |
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 infrastructure and established expertise in endocrinology to expand reach,
increase awareness and drive T1D screening |
| ● |
Sanofi
to invest $35 million at a premium after a potential teplizumab FDA approval |
| ● |
Investor
Conference call at 8:30am ET Today |
RED
BANK, N.J., October 6, 2022 /PRNewswire/ — Provention Bio, Inc. (Nasdaq: PRVB) (the “Company”), a biopharmaceutical
company dedicated to intercepting and preventing immune-mediated diseases, today announced that the Company has entered into a co-promotion
agreement with Sanofi U.S. for the launch of Provention’s lead investigational drug candidate teplizumab. The agreement enables
Provention Bio to leverage Sanofi’s expertise, capabilities and commercial resources to support the potential launch of teplizumab
currently under review by the U.S. Food and Drug Administration (“FDA”), for the delay of clinical type 1 diabetes in at-risk
individuals, with a user fee goal date of November 17, 2022 for the Biologics License Application.
“This
collaboration with Sanofi U.S. allows us to significantly expand our planned commercial footprint during launch to support increased
screening and product awareness as we work to launch a new therapy that, if approved, will dramatically impact the lives of the patients
and families we serve,” said Jason Hoitt, Chief Commercial Officer, Provention Bio. “In particular, Sanofi’s long-standing
relationships with key U.S. healthcare professionals will complement our focus on pediatric endocrinologists and help us address a larger
patient population with greater efficiency.”
Olivier
Bogillot, Head of U.S. General Medicines, Sanofi, stated, “We are delighted by the prospect of supporting Provention Bio in bringing
to the U.S. what could become the first-in-class therapy to change the course of type 1 diabetes. If approved, Sanofi U.S. will leverage
its existing world-class capabilities in diabetes care to enhance efforts in both patient and healthcare provider access. We are prepared
to tap into all of our internal expertise to support the successful launch of this innovative therapy.”
“The
agreement brings significant resources to Provention and allows us to advance our mission of delivering therapies which intercept or
delay debilitating and life-threatening autoimmune diseases,” said Ashleigh Palmer, Co-Founder and Chief Executive Officer, Provention
Bio. “We look forward to working with our colleagues at Sanofi as we prepare to deliver, if approved, the first-ever disease-modifying
therapy for T1D.”
Co-Promotion
Agreement
Under
the terms of the agreement, Sanofi will commit commercial resources in the United States, including diabetes field specialists, account
directors, field-based reimbursement and medical science liaisons to expand the number of key healthcare professionals reached in the
United States. In exchange, Provention will reimburse field force-related expenses that Sanofi will incur in connection with commercializing
teplizumab under the agreement.
Provention
retains all rights to teplizumab and maintains responsibility for the commercialization strategy.
Right
of First Negotiation to Global Commercial Rights
The
Company also granted Sanofi, in consideration of a one-time payment of $20 million, an exclusive, one-time right of first negotiation
(ROFN) to obtain exclusive global rights to commercialize teplizumab for Type 1 diabetes indications in humans, subject to certain retained
rights of the Company to engage in discussions with third parties with respect to certain transactions. Sanofi may exercise the ROFN,
until June 30, 2023, with an option to extend within 2023 under certain conditions.
Equity
Investment
Simultaneous
with their entry into the co-promotion agreement, the Company and Sanofi entered into a Securities Purchase Agreement (the “Purchase
Agreement”). Pursuant to the Purchase Agreement, if teplizumab is approved by the FDA, Sanofi has agreed to purchase $35 million
of the Company’s common stock at a premium over the daily volume-weighted average per share price for the five consecutive trading
days prior to the closing date. The closing date will be at Provention’s discretion and would occur no later than February 16,
2023.
BofA
Securities acted as financial advisor to the Company on this transaction.
For
important information related to the terms of the Co-Promotion Agreement and Securities Purchase Agreement, see Provention Bio’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on October 6, 2022.
Conference
Call and Webcast Information
Provention
Bio will discuss this business update via conference call today at 8:30 am ET. To access the call, please dial 1-888-347-7861 (domestic)
or 1-412-902-4247 (international) ten minutes prior to the start time and ask to be connected to the “Provention Bio Call.”
An audio webcast will also be available on the “Events and Webcasts” page of the Investors section of the Company’s
website, www.proventionbio.com. An archived webcast will be available on the Company’s website approximately two hours after
the conference call.
About
Teplizumab
Teplizumab
is an anti-CD3 monoclonal antibody that is being developed for the delay of clinical T1D in at-risk individuals, as indicated by the
presence of two or more T1D-related autoantibodies. There has been no disease-modifying innovation for this life-impacting and life-threatening
autoimmune disease since the development of insulin a century ago. More than 800 patients have received teplizumab in multiple clinical
studies involving more than 1,000 subjects. Provention is currently also evaluating teplizumab in patients with newly diagnosed insulin-dependent
T1D (the Phase 3 PROTECT study).
About
Provention Bio, Inc.
Provention
Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical company focused on advancing the development of investigational therapies that
may intercept and prevent debilitating and life-threatening immune-mediated diseases. The Biologics License Application (BLA) for teplizumab,
its lead investigational drug candidate, for the delay of progression to Stage 3 clinical type 1 diabetes in at-risk individuals has
been filed by the U.S. Food and Drug Administration (FDA). The Company’s pipeline includes additional clinical-stage product candidates
that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in other autoimmune diseases, including
celiac disease and lupus. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.
Internet
Posting of Information
Provention
Bio, Inc. uses its website, www.proventionbio.com, 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 Company’s ability
to leverage Sanofi’s expertise, capabilities and commercial resources to support the potential launch of teplizumab, the potential
that the collaboration with Sanofi to significantly expand the Company’s planned commercial footprint during launch, the potential
exercise of the ROFN by Sanofi, the potential approval and commercialization of teplizumab and the potential closing of the common stock
offering to Sanofi. These statements may be identified by the use of forward-looking words such as “may” and “potential,”
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, risks related to FDA disagreeing with the Company’s interpretation of
data and analysis and information in the BLA resubmission; delays in or failure to obtain FDA approvals for teplizumab or other Company
product candidates and the potential for noncompliance with FDA regulations; any inability to successfully work with FDA to address its
concerns and requests in a timely manner or at all during the review process for teplizumab, including any inability to provide the FDA
with data, analysis or other information sufficient to support an approval of the BLA for teplizumab; any inability to satisfactorily
address matters related to PK comparability, product quality, safety or any other FDA requirements during the BLA review process to obtain
an approval of teplizumab; 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; the Company’s dependence upon third
parties; substantial competition; the Company’s need for additional financing and the risks listed under “Risk Factors”
in the Company’s quarterly report on Form 10-Q for the quarter ended June 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
Contacts:
Thierry
Chauche, Chief Financial Officer
tchauche@proventionbio.com
Brendan
Strong
Argot
Partners
Proventionbio@argotpartners.com
212-600-1902
Media
Contact:
Kaelan
Hollon, VP of Communications
khollon@proventionbio.com
202-421-4921