Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage
biopharmaceutical company focused on Artificial Intelligence
(“AI”)-driven therapeutic drug development for the treatment of
non-alcoholic steatohepatitis (“NASH”) and hepatocellular carcinoma
(“HCC”), today urged its stockholders to vote “FOR” all proposals
put forth in the definitive proxy statement prior to its June 24,
2022 Annual Meeting of Stockholders.
“As one equity analyst recently observed in a
research note, our industry is facing one of the worst biotech
tapes in a generation,” said Dr. Robert Foster, PharmD, PhD,
Hepion’s CEO. “Indeed, since the market peaked in February 2021,
the aggregate enterprise value of the world’s biotech sector is
down approximately 50%, and over one-half of individual biotech
sector stocks have lost 75% or more of their value.1 While there is
certainly reason for optimism over the longer-term, it is in the
face of these current strong headwinds that we urgently need our
shareholders’ support to help us continue to advance rencofilstat,
our lead oral drug candidate for the treatment of NASH and
HCC.”
SUPPORT THE PROPOSALS AND HELP HEPION
CONTINUE TO ADVANCE RENCOFILSTAT
Hepion is making final preparations for the
launch of three important mid-stage clinical studies of
rencofilstat: a 12-month Phase 2b NASH study of over 300 subjects
with paired liver biopsies, called ‘ASCEND-NASH’; a 4-month Phase 2
liver function trial in NASH, called ‘ALTITUDE-NASH’; and a
12-month Phase 2a study (HEPA-CRV431-209) in HCC.
The initiation of patient enrollment in all
three Phase 2 studies is currently expected to occur in the third
quarter of 2022. In addition, the Company today announces that it
has recently begun to actively explore partnering and licensing
opportunities for rencofilstat.
With respect to Proposal 3 (2022 Omnibus Equity
Incentive Plan), Dr. Foster commented, “It is perhaps more
important now than ever that our ability to attract and retain the
best possible team is not impeded, which without an affirmative
vote on this proposal, may very well be the case. In addition to
our inability to provide any new stock-based incentives to our
executives and employees, there are currently a total of
approximately 6.3 million options, which have previously been
granted across the entire Company, but cannot actually vest and/or
be exercised, due to a lack of available shares issuable under our
2013 Option Plan, as amended. Notwithstanding the fact those
options all have exercise prices that are significantly higher than
our current stock price, this is an untenable situation, which
cannot be resolved without approval of the replacement 2022 Omnibus
Equity Incentive Plan.”
In regard to Proposal 4 (Change in Authorized
Shares), Dr. Foster said, “Because this involves a proposed
amendment to the Company’s Certificate of Incorporation, the
affirmative vote of the holders of a majority of our outstanding
common shares is required to approve it. As some brokerage firms
have eliminated discretionary or proportionate voting of the shares
held by them in street name, this level of voting participation has
become increasingly difficult for companies like Hepion with a
large retail stockholder base to achieve. The hurdle is high, but
so are the stakes. Conducting three Phase 2 studies simultaneously
will clearly necessitate significant ongoing investment, and we
believe that the availability of additional authorized shares is
required to meet our needs for future financings as conditions
warrant, as well as to best position us for potential strategic
transactions.”
YOUR VOTE IS IMPORTANT – NO MATTER HOW
MANY OR HOW FEW SHARES YOU OWN
Stockholders holding common stock at the close
of business on Tuesday, April 26, 2022, are entitled to vote at the
meeting, even if they have subsequently sold their shares.
To vote their shares, stockholders should locate
the control number on their proxy card or voting instruction form
and follow the voting instructions.
If a stockholder has questions, or is in need
assistance in voting their shares, they should contact Innisfree
M&A Incorporated at (877) 717-3898 (toll-free in the U.S. and
Canada) or +1 412-232-3651 (international).
Important Information
This communication may be deemed to be
solicitation material in connection with the proposals to be
considered at Hepion Pharmaceuticals’ 2022 Annual Meeting of
Stockholders. In connection with the proposals, the Company filed a
definitive proxy statement on Schedule 14A with the U.S. Securities
and Exchange Commission (the “SEC”) on April 29, 2022. Shareholders
are urged to read the definitive proxy statement and all other
relevant documents filed with the SEC because they contain
important information about the proposals. An electronic copy of
the definitive proxy statement is available on the Company’s
website at www.hepionpharma.com under "SEC Filings" in the
Investors section, and on the Company’s EDGAR profile at
www.sec.gov.
Reference
1 FactSet Research Systems, Inc.
About Hepion
Pharmaceuticals
The Company's lead drug candidate, rencofilstat,
is a potent inhibitor of cyclophilins, which are involved in many
disease processes. Rencofilstat is currently in clinical-phase
development for the treatment of NASH, with the potential to play
an important role in the overall treatment of liver disease - from
triggering events through to end-stage disease. Rencofilstat has
been shown to reduce liver fibrosis and hepatocellular carcinoma
tumor burden in experimental models of NASH, and has demonstrated
antiviral activities towards HBV, HCV, and HDV through several
mechanisms, in nonclinical studies. In November 2021, the U.S. Food
and Drug Administration (“FDA”) granted Fast Track designation for
rencofilstat for the treatment of NASH. That was soon followed in
December 2021 by the FDA’s acceptance of Hepion’s investigational
new drug (IND) application for rencofilstat for the treatment of
hepatocellular carcinoma (HCC).
Hepion has created a proprietary AI platform,
called AI-POWR™, which stands for Artificial
Intelligence - Precision Medicine;
Omics (including genomics, proteomics,
metabolomics, transcriptomics, and lipidomics);
World database access; and
Response and clinical outcomes. Hepion intends to
use AI-POWR™ to help identify which NASH patients will best respond
to rencofilstat, potentially shortening development timelines and
increasing the delta between placebo and treatment groups. In
addition to using AI-POWR™ to drive its ongoing NASH clinical
development program, Hepion intends to use the platform to identify
additional potential indications for rencofilstat to expand the
company's footprint in the cyclophilin inhibition therapeutic
space.
Forward Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by the use of forward-looking words such as “anticipate,”
“believe,” “forecast,” “estimated,” and “intend,” among others.
These forward-looking statements are based on Hepion
Pharmaceuticals’ 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, substantial competition; our ability to continue as a
going concern; our need for additional financing; uncertainties of
patent protection and litigation; risks associated with delays,
increased costs and funding shortages caused by the COVID-19
pandemic; uncertainties with respect to lengthy and expensive
clinical trials, that results of earlier studies and trials may not
be predictive of future trial results; uncertainties of government
or third party payer reimbursement; limited sales and marketing
efforts and dependence upon third parties; and risks related to
failure to obtain FDA clearances or approvals and noncompliance
with FDA regulations. As with any drug candidates under
development, there are significant risks in the development,
regulatory approval, and commercialization of new products. There
are no guarantees that future clinical trials discussed in this
press release will be completed or successful, or that any product
will receive regulatory approval for any indication or prove to be
commercially successful. Hepion Pharmaceuticals does not undertake
an obligation to update or revise any forward-looking statement.
Investors should read the risk factors set forth in Hepion
Pharmaceuticals’ Form 10-K for the year ended December 31, 2021,
and other periodic reports filed with the Securities and Exchange
Commission.
For further information, please contact:
Stephen KilmerHepion Pharmaceuticals Investor RelationsDirect:
(646) 274-3580skilmer@hepionpharma.com
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