Current Report Filing (8-k)
June 15 2020 - 3:45PM
Edgar (US Regulatory)
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
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001-38552
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81-5245912
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(State
or Other Jurisdiction
of
Incorporation)
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(Commission
File
Number)
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(IRS
Employer
Identification
No.)
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P.O.
Box 666, Oldwick, New Jersey 08858
(Address
of principal executive offices) (Zip Code)
Registrant’s
telephone number, including area code: (908) 336-0360
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 (see General Instruction A.2. below):
[ ]
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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[ ]
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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[ ]
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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[ ]
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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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 [X]
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. [X]
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class
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Trading
Symbol(s)
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Name
of Each Exchanged on Which Registered
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Common
Stock, $0.0001 par value per share
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PRVB
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The
Nasdaq Global Select Market
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Item
7.01. Regulation FD.
On June 15, 2020, Provention
Bio, Inc. (the “Company”) issued a press release announcing new data from a Phase 2 open-label extension study of
the NIH-sponsored At-Risk (TN-10) type 1 diabetes (T1D) study. A copy of the press release is furnished as Exhibit 99.1 hereto
and shall not be deemed “filed” for the purposes 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
8.01. Other Events.
Investor
Presentation
The Company is
using the slides attached hereto in connection with management presentations to describe its business. A copy of the investor
presentation is available at the Company’s website at http://investors.proventionbio.com/home, and attached hereto as Exhibit
99.2, and is incorporated herein by reference.
The
content of the Company’s website is not incorporated by reference in this Current Report on Form 8-K.
Clinical Data & Safety
On June 15, 2020, the
Company announced the results that one 14-day course of its lead drug candidate, teplizumab (PRV-031) significantly delayed the
onset of clinical T1D, as compared to placebo, by a median of three years in at-risk patients. These new data from the “At-Risk”
TN-10 Study add one year to the two-year median delay that was previously determined.
The “At-Risk”
TN-10 Study, a pivotal Phase 2 clinical trial, evaluated teplizumab for the delay of clinical (T1D) in at-risk patients. At-risk
was defined by the presence of two or more T1D-related autoantibodies and dysglycemia (abnormal glucose metabolism). Seventy-six
subjects were enrolled ages 8 to 49, with 72 percent under the age of 18, and randomized to receive a single course of either
teplizumab or placebo. Subjects were followed in a blinded fashion until 40 of them developed clinical T1D, and then indefinitely
after the analysis of the randomized period data.
The trial results showed
the median time to clinical diagnosis of T1D after one course of teplizumab was approximately five years (an improvement of 12
months from previously published data) compared to approximately two years for the placebo group (unchanged from previously published
data). Nearly half of those treated with teplizumab are estimated to be free of clinical T1D at five years. The hazard ratio was
0.457 or a 54 percent reduction in risk (p=0.01).
In addition, teplizumab
treatment was associated with a greater on-study C-peptide (p=0.009) compared to placebo. For both groups, C-peptide AUC mean
slopes preceding study entry were similar and declining. In the placebo group, this decline continued over the 6 months after
study entry. By contrast, the teplizumab-treated group showed an increased C-peptide AUC over this period (p=0.02 relative to
study entry).
The results also showed that teplizumab
was well tolerated and the safety data is consistent from previous analyses.
Cautionary Note on Forward-Looking
Statements
This Current Report
on Form 8-K contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995
and other federal securities laws. Any statements contained herein that do not describe historical facts are forward-looking statements
that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking
statements. Such risks and uncertainties include, but are not limited to, risks and uncertainties surrounding the COVID-19 pandemic,
including the impact to the Company’s clinical trial programs, risks related to failure to obtain FDA approvals or clearances
and noncompliance with FDA regulations, uncertainties of patent protection and litigation, limited research and development efforts
and dependence upon third parties, substantial competition, and the risks detailed from time to time in the Company’s filings
with the Securities and Exchange Commission (“SEC”), including those described under “Risk Factors” in
the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, as updated by its Quarterly Report on Form
10-Q for the quarter ended March 31, 2020, and the documents incorporated by reference herein and therein. Any of these risks
and uncertainties could materially and adversely affect the Company’s results of operations. The Company cautions you not
to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company undertakes
no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the
date they were made or to reflect the occurrence of unanticipated events.
Item 9.01 Financial Statements and Exhibits.
(d)
The following exhibit is furnished with this report:
SIGNATURE
Pursuant
to the requirement of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned thereunto duly authorized.
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Provention
Bio, Inc.
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Date:
June 15, 2020
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By:
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/s/
Andrew Drechsler
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Andrew
Drechsler
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Chief
Financial Officer
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