ViralClear Closes $10.8 Million Equity Financing for Development of COVID-19 Broad-Spectrum Oral Anti-Viral Candidate Merime...
May 20 2020 - 10:12AM
- Funding completed in subsidiary without dilution to
BioSig common stock
- Phase II human trials for merimepodib,
a broad-spectrum oral anti-viral treatment of adult
hospitalized patients with COVID-19, are planned to commence at
three Mayo Clinic sites
BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the
“Company”), and its subsidiary, ViralClear Pharmaceuticals, Inc.,
today announced the closing of a $10.8 million common stock
financing. ViralClear plans to use the proceeds of this offering
for the development, including phase II human clinical trials, of
its product candidate merimepodib, a broad-spectrum anti-viral
agent. The financing was completed at a $100 million pre-money
valuation.
“The successful completion of this funding in these challenging
times represents the investor’s confidence and support of our
clinical program,” commented Kenneth L. Londoner, Chairman and CEO
of BioSig Technologies, Inc. and Director of ViralClear
Pharmaceuticals, Inc. “With the FDA clearing our Investigational
New Drug application earlier this week, we intend to deploy these
proceeds toward our clinical trials – and what we hope will be
timely solution to the current public health crisis.”
On May 18, 2020, ViralClear announced the FDA’s clearance of its
IND to proceed with a proposed phase II study of merimepodib in
COVID-19 patients. The human clinical trials are planned to be
conducted under leadership of Dr. Andrew D. Badley, Professor and
Chair of the Department of Molecular Medicine and the Enterprise
Chair of the COVID-19 Task Force at Mayo Clinic.
Introducing broker, Laidlaw & Company (UK) Ltd. participated
in the transaction.
About BioSig Technologies BioSig Technologies
is a medical technology company commercializing a proprietary
biomedical signal processing platform designed to improve signal
fidelity and uncover the full range of ECG and intra-cardiac
signals (www.biosig.com). The Company’s first product, PURE EP(tm)
System is a computerized system intended for acquiring, digitizing,
amplifying, filtering, measuring and calculating, displaying,
recording and storing of electrocardiographic and intracardiac
signals for patients undergoing electrophysiology (EP) procedures
in an EP laboratory.
About Merimepodib (MMPD) Merimepodib, a
broad-spectrum anti-viral candidate, that demonstrates strong
activity against COVID-19 in cell cultures in laboratory testing
and additional antiviral studies are underway. Merimepodib
was previously in development as a treatment for chronic hepatitis
C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex),
with 12 clinical trials conducted (including 315 chronic hepatitis
C patients, 24 psoriasis patients, and 98 healthy volunteers) and
an extensive preclinical safety package completed.
A manuscript titled, “The IMPDH inhibitor merimepodib provided
in combination with the adenosine analogue remdesivir reduces
SARS-CoV-2 replication to undetectable levels in vitro”, was
submitted to an online peer-reviewed life sciences journal. This
manuscript is authored by Natalya Bukreyeva, Rachel A. Sattler,
Emily K. Mantlo, John T. Manning, Cheng Huang and Slobodan Paessler
of the UTMB Galveston National Laboratory and Dr. Jerome Zeldis of
ViralClear Pharmaceuticals, Inc. (“ViralClear”) as a corresponding
author. This article highlights pre-clinical data generated under
contract with Galveston National Laboratory at The University of
Texas Medical Branch.
About ViralClearBioSig’s subsidiary ViralClear
Pharmaceuticals, Inc., is seeking to develop a novel pharmaceutical
to treat COVID-19. Merimepodib is intended to be orally
administered, and has demonstrated broad-spectrum in vitro
antiviral activity, including strong activity against COVID-19 in
cell cultures. Merimepodib has been previously studied in 12
clinical trials, including 5 in patients with hepatitis C (1 Phase
1b, 1 Phase 2, 2 Phase 2a, and 1 Phase 2b), 1 in patients with
psoriasis (Phase 2), and six in healthy volunteers (Phase
I).
Forward-looking Statements
This press release contains “forward-looking statements.” Such
statements may be preceded by the words “intends,” “may,” “will,”
“plans,” “expects,” “anticipates,” “projects,” “predicts,”
“estimates,” “aims,” “believes,” “hopes,” “potential” or similar
words. Forward- looking statements are not guarantees of future
performance, are based on certain assumptions and are subject to
various known and unknown risks and uncertainties, many of which
are beyond the Company’s control, and cannot be predicted or
quantified and consequently, actual results may differ materially
from those expressed or implied by such forward-looking statements.
Such risks and uncertainties include, without limitation, risks and
uncertainties associated with (i) the geographic, social and
economic impact of COVID-19 on our ability to conduct our business
and raise capital in the future when needed, (ii) our inability to
manufacture our products and product candidates on a commercial
scale on our own, or in collaboration with third parties; (iii)
difficulties in obtaining financing on commercially reasonable
terms; (iv) changes in the size and nature of our competition; (v)
loss of one or more key executives or scientists; and (vi)
difficulties in securing regulatory approval to market our products
and product candidates. More detailed information about the Company
and the risk factors that may affect the realization of
forward-looking statements is set forth in the Company’s filings
with the Securities and Exchange Commission (SEC), including the
Company’s Annual Report on Form 10-K and its Quarterly Reports on
Form 10-Q. Investors and security holders are urged to read these
documents free of charge on the SEC’s website at
http://www.sec.gov. The Company assumes no obligation to publicly
update or revise its forward-looking statements as a result of new
information, future events or otherwise.
Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
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