Hepion Pharmaceuticals, Inc. (Nasdaq: HEPA), a clinical stage
biopharmaceutical company that has been developing a treatment for
non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma
(“HCC”), and other chronic liver diseases, today announced it has
entered into a definitive merger agreement (the “Merger Agreement”)
with Pharma Two B Ltd., a late-clinical stage private Israeli
company that is developing P2B001, an innovative combination
product candidate in development for the treatment of Parkinson’s
Disease (“PD”). Under the Merger Agreement, Hepion will merge into
and become an indirectly wholly-owned subsidiary of Pharma Two B
(the “Merger”). The combined company will continue to operate under
the "Pharma Two B" name and Pharma Two B has agreed to file a
registration statement on Form F-4 (the “Form F-4”) with the U.S.
Securities and Exchange Commission (the “SEC”) to register the
ordinary shares proposed to be issued (or reserved for issuance) to
Hepion’s equity-holders in the acquisition, and will also apply to
list its ordinary shares on Nasdaq under the ticker symbol “PHTB”.
“P2B001 offers a novel, easy-to-use therapeutic
approach, that is designed to address the unmet need for an
effective, safe, once-daily, no titration required treatment with a
lower incidence of excessive daytime sleepiness—a common side
effect of currently available dopamine agonist treatments in
Parkinson’s disease patients” said Dan Teleman, Chief Executive
Officer of Pharma Two B. “As we advance P2B001’s development
following the successful completion of our Phase 3 clinical trial,
we believe it is the right time to enter the public equity markets.
Our company is in a stage that we believe meets the public market
and investors' expectations. We are excited about Pharma Two B’s
next growth phase, moving P2B001 towards an NDA submission targeted
for the first half of 2026 and making this potential treatment
available to patients,” he continued.
“Consistent with our December 7, 2023
announcement, the Hepion Board of Directors conducted a review of
multiple strategic alternatives to identify paths to provide value
to our stockholders. We believe the transaction we are announcing
today with Pharma Two B Ltd. presents an excellent opportunity for
our shareholders to become a part of a company poised to file an
NDA in a therapeutic area with a major unmet medical need,” said
John Brancaccio, Executive Chairman.
Hepion has also announced a private placement of
$2.9 million non-convertible senior notes to qualified
institutional investors. The notes are unsecured, interest-free,
and were issued with an aggregate $400.0 thousand original issue
discount, and mature at the earlier of: (i) December 31, 2024; (ii)
the closing of Merger; or (iii) the termination of Merger pursuant
to terms of Merger Agreement. Hepion also loaned $600.0 thousand of
the proceeds to Pharma Two B through a non-convertible unsecured
note that bears nominal interest and matures on the same terms as
the $2.9 million notes, but which will be forgiven and cancelled
upon consummation of the Merger. In connection with the purchase of
the notes, the investors received 1,159,245 shares of Hepion common
stock, or approximately 19.99% of Hepion’s outstanding common stock
immediately prior to the issuance.
In support of the Merger, Pharma Two B has
entered into a securities purchase agreement for an $11.5 million
private placement of ordinary shares (or pre-funded warrants in
lieu thereof) and accompanying Series A warrants and Series B
warrants with a syndicate of new and existing institutional life
science investors. The private placement is expected to close
immediately after the closing of the Merger. The Series A warrants
will have a 5-year term, and an exercise price of $6.00 per
ordinary share. The Series B warrants will have a 2.5-year term,
and an exercise price of $6.00 per ordinary share. The warrants
will have customary anti-dilution adjustments as well as
anti-dilution price protection and share adjustment features,
subject to a floor price of 20% of the initial exercise price per
share, as well as a cash true up feature, in each case subject to
certain limitations. Pharma Two B has agreed to register for resale
the shares (including shares underlying the warrants) to be issued
in the concurrent private financing.
The securities offered and sold in the private
placements by each of Hepion and Pharma Two B will not be
registered under the Securities Act of 1933, as amended (the
“Securities Act”), or any state or other applicable jurisdiction’s
securities laws, and may not be offered or sold in the United
States absent registration or an applicable exemption from the
registration requirements of the Securities Act and applicable
state or other jurisdictions’ securities laws.
Merger Overview
Under the terms of the Merger Agreement, the
Merger is valued at an estimated pro-forma implied equity value of
approximately $58.5 million. At close, Pharma Two B expects up to
$11.5 million of gross cash proceeds, and intends to use net
proceeds to fund continuing growth and expansion of its lead
product candidate P2B001 and repay up to $2.9 million of Hepion’s
senior unsecured notes to the extent outstanding at closing of the
Merger.
Following the Merger, the combined company will
continue to be led by Pharma Two B’s management, a highly
experienced team in PD, supported by top-tier scientific and
clinical key opinion leaders and backed by a dedicated group of
investors.
Additional information about the Merger and the
private placements will be provided in a Current Report on Form 8-K
that will be filed by Hepion with the SEC and will be available at
www.sec.gov. The Merger is expected to close in the fourth quarter
of 2024 and is subject to approval by Hepion’s stockholders,
regulatory approval, and other customary closing conditions.
Advisors
A.G.P./Alliance Global Partners is serving as
financial advisor to Hepion and Sheppard, Mullin, Richter &
Hampton LLP is acting as U.S. legal advisor to Hepion and Lipa Meir
& Co.is acting as Israeli legal advisor to Hepion. Sullivan
& Worcester LLP is serving as legal advisor to A.G.P.
Laidlaw & Company (UK) Ltd. is acting as
financial advisor to Pharma Two B. and Meitar Law Offices and
Goodwin Procter LLP are acting as legal advisors to Pharma Two
B.
About Pharma Two B
Pharma Two B is a private, late-stage
pharmaceutical company. Pharma Two B’s mission is to improve
patients’ quality of life by developing innovative, value-added
combination drugs for neurological disorders, with a clear unmet
need, that are based on previously approved oral drugs and that may
offer meaningful clinical benefits, as well as improved safety and
enhanced convenience. Pharma Two B’s lead product is P2B001. For
more information, please visit: www.pharma2b.com.
About P2B001
P2B001 is an investigational, novel, fixed-dose,
extended-release combination of pramipexole and rasagiline (0.6
mg/0.75 mg), both at low doses that are not commercially available.
Marketed pramipexole and rasagiline are currently indicated for the
treatment of PD (as monotherapy and adjunct therapy for early and
more advanced patients). P2B001 is being developed for potential
use as a first-line therapy for people with PD. Extended release
rasagiline is a new and proprietary formulation of rasagiline
developed by Pharma Two B.
In a Phase 3 clinical trial, P2B001 demonstrated
that it provides benefits comparable with commercially used doses
of marketed pramipexole-ER (PramiER) while minimizing associated
daytime sleep-related and dopaminergic side effects associated.
Pharma Two B owns worldwide-granted patents for
both pharmaceutical composition and method of treatment with
P2B001.
About Hepion Pharmaceuticals
Hepion’s primary asset, Rencofilstat, is a
potent inhibitor of cyclophilins, which are involved in many
disease processes. Rencofilstat has been shown to reduce liver
fibrosis and hepatocellular carcinoma tumor burden in experimental
disease models. In November 2021, the U.S. Food and Drug
Administration (“FDA”) granted Fast Track designation for
rencofilstat for the treatment of NASH. That was followed in June
2022 by the FDA’s granting of Orphan Drug designation to
rencofilstat for the treatment of HCC.
In April 2024, Hepion announced that it was
winding down its ASCEND-NASH clinical trial. This trial was
designed as a Phase 2b, randomized, multi-center, double-blinded
study with first patient screened in August 2022, to evaluate the
safety and efficacy of Rencofilstat dosed for 12 months, with a
target enrollment of 336 subjects. Enrollment was paused in April
2023, with 151 subjects randomized. To date, approximately 80
subjects have completed their Day 365 visits and are evaluable for
both safety and efficacy. An additional 40 subjects will provide
significant safety data for evaluation. These patients will be
added to Hepion’s existing safety database. The data from this
trial and all rights to Reconfilstat will belong to existing
stockholders of Hepion and to the extent that cash resources are
available, Hepion will continue efforts to provide any value
derived to its stockholders.
Forward-Looking Statements
Certain statements in this press release may be
considered “forward-looking statements”. Forward-looking statements
generally relate to future events or Hepion’s or Pharma Two B’s
future financial or operating performance. For example, statements
regarding Hepion and Pharma Two B's expectations with respect to
the Merger, including the timing of closing thereof and pro forma
ownership of the combined company, the concurrent financing, the
cash runway of the combined company; planned timing of New Drug
Application (“NDA”) submission, P2B001 potential as a treatment for
PD and label expansion, projected net revenues, and related
matters, as well as all other statements other than statements of
historical fact included in this press release, are forward-looking
statements. When used in this press release, words such as
“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”
“intend,” “may,” “might,” “plan,” “possible,” “potential,”
“predict,” “project,” “should,” “would” and similar expressions, as
they relate to Hepion or Pharma Two B, identify forward-looking
statements. Such forward-looking statements are based on the
beliefs of management, as well as assumptions made by, and
information currently available to, Hepion’s and Pharma Two B's
management. Actual results could differ materially from those
contemplated by the forward-looking statements as a result of
certain factors detailed in Hepion’s filings with the SEC. Most of
these factors are outside the control of Hepion and/or Pharma Two B
and are difficult to predict. In addition to factors disclosed in
Hepion’s filings with the SEC, the following factors, among others,
could cause actual results and the timing of events to differ
materially from the anticipated results or other expectations
expressed in the forward-looking statements: the risk that the
Merger may not be completed in a timely manner or at all, which may
adversely affect the price of the securities of Hepion; the
inability to meet the closing conditions to the Merger, including
the failure of Pharma Two B to meet Nasdaq initial listing
standards in connection with the consummation of the Merger; costs
related to the Merger and the failure to realize anticipated
benefits of the Merger or to realize estimated pro forma results
with respect thereto as well as other risks associated with
biopharmaceutical companies generally, including the risks of
filing an NDA, obtaining regulatory approval for any product
candidates, commercialization of any approved product, including
P2B001 for PD, as well as the total addressable market and
potential for success of P2B001, the presentation of financial
information in U.S. GAAP, completion of a PCAOB audit of U.S. GAAP
financials, as well as other risks that will be set forth in more
detail in the registration statement on Form F-4 (which will
include a proxy statement/prospectus), when filed with the SEC. The
forward-looking statements are based upon management’s beliefs and
assumptions; and other risks and uncertainties to be identified on
Form F-4 (when available) relating to the Merger, including those
under “Risk Factors” therein, and in other filings with the SEC
made by Hepion. Each of Hepion and Pharma Two B undertake no
obligation to update these statements for revisions or changes
after the date of press release, except as required by law.
No Offer or Solicitation
This press release does not constitute an offer
to sell or a solicitation of an offer to buy, or the solicitation
of any vote or approval in any jurisdiction in connection with the
proposed Merger or any related transactions, nor shall there be any
sale, issuance or transfer of securities in any jurisdiction where,
or to any person to whom, such offer, solicitation or sale may be
unlawful. Any offering of securities or solicitation of votes
regarding the proposed transaction will be made only by means of a
proxy statement/prospectus that complies with applicable rules and
regulations promulgated under the Securities Act, and the
Securities Exchange Act of 1934, as amended, or pursuant to an
exemption from the Securities Act or in a transaction not subject
to the registration requirements of the Securities Act.
Additional Information and Where to Find
It
In connection with the proposed Merger, Pharma
Two B intends to file the Form F-4 with the SEC, which will include
a preliminary prospectus with respect to its securities to be
issued in connection with the Merger, and a preliminary proxy
statement with respect to Hepion’s stockholder meeting at which
Hepion’s stockholders will be asked to vote on the proposed Merger
and related matters. Each of Hepion and Pharma Two B urge
investors, stockholders, and other interested persons to read, when
available, the Form F-4, including the proxy statement/prospectus,
any amendments thereto, and any other documents filed with the SEC,
before making any voting or investment decision because these
documents will contain important information about the proposed
Merger. After the Form F-4 has been filed and declared effective,
Pharma Two B and Hepion will mail the definitive proxy
statement/prospectus to stockholders of Hepion as of a record date
to be established for voting on the Merger. Hepion’s stockholders
will also be able to obtain a copy of such documents, without
charge, by directing a request to: Executive Chairman at
info@hepionpharma.com.
Participants in the
Solicitation
Pharma Two B and Hepion and their respective
directors and executive officers may be deemed to be participants
in the solicitation of proxies from Hepion’s stockholders in
connection with the proposed Merger. Information about Hepion’s
directors and executive officers and their ownership of Hepion’s
securities is set forth in Hepion’s filings with the SEC. To the
extent that holdings of Hepion’s securities have changed since the
amounts printed in Hepion’s Annual Report on Form 10-K/A, such
changes have been or will be reflected on Statements of Change in
Ownership on Form 4 filed with the SEC. A list of the names of such
directors and executive officers and information regarding their
interests in the Merger will be contained in the proxy
statement/prospectus when available. You may obtain free copies of
these documents as described in the preceding paragraph.
Contact Information
Hepion
Pharmaceuticals732-902-4000info@hepionpharma.com
Pharma Two B Ltd.Dan Teleman,
CEOEmail: dan@pharma2b.comwww.pharma2b.com
Hepion Pharmaceuticals (NASDAQ:HEPA)
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Hepion Pharmaceuticals (NASDAQ:HEPA)
過去 株価チャート
から 12 2023 まで 12 2024