Entero Therapeutics, Inc., (NASDAQ: ENTO), (“Entero Therapeutics”
or the “Company”), a clinical-stage biopharmaceutical company
specializing in the development of targeted, non-systemic therapies
for gastrointestinal (GI) diseases, today announced its entry
into a binding letter of intent (the “Letter of Intent”) with Data
Vault Holdings, Inc. (“Data Vault”), a privately held technology
holding company, to exclusively license two technology product
suites owned by Data Vault -- QOLPOM® and FotoDigm® (the “Proposed
Transaction”). Entero Therapeutics will work with Data Vault before
and after the closing of the Proposed Transaction to secure funding
for the customization of this clinical trial compliance software
that includes a focus on the use of DigitalTwins and
high-performance computing. In parallel, Entero Therapeutics plans
to develop applications for its own near-term use with
gastrointestinal (GI) clinical trials beginning with the planned
Phase 3 trial for latiglutenase for the treatment of celiac
disease.
Under the terms of the Letter of Intent, Entero
Therapeutics, upon execution of a definitive agreement, would
receive an exclusive, global license to pilot the technology
platform in Entero Therapeutics’ clinical trials, and to develop
and commercialize Data Vault’s QOLPOM® and FotoDigm® patented
pharmaceutical regime compliance software for use in clinical
trials with third-parties in the pharma and biotech sectors. In
consideration, Entero Therapeutics will issue to Data Vault shares
of the Company’s convertible preferred stock priced at a premium to
the market and single digit revenue sharing royalties on net sales.
The Proposed Transaction is expected to close by the end of
September, and the entry into definitive documentation will be
conditioned upon fulfillment requirements of no less than $500K of
strategic investment into Entero Therapeutics (the “Strategic
Investment”), with a target of ultimately securing up to $3 million
of further strategic investment with Data Vault’s assistance. The
terms of the Proposed Transaction provide for Data Vault to support
the Company’s pursuit of the Strategic Investment. The Strategic
Investment would provide Entero Therapeutics with access to both
capital and technology for a pilot program and the initiation and
potential improvement of the Company’s future clinical trials.
James Sapirstein, Chairman and CEO of Entero
Therapeutics, added, “We are very pleased to have the opportunity
to secure an exclusive, worldwide license from Data Vault for its
clinical trial compliance technology platform. Compliance is a
major issue in drug development – it directly impacts the
time, cost and success of clinical trials. We believe that the
software platform has the potential to improve outcomes for our
Phase 3 latiglutenase trial in celiac disease, along with the other
GI therapeutic indications that we are planning to pursue. Both
companies are committed to working together to customize the
software for the latiglutenase trial. Our clinical trials would be
the testing ground for these products and we believe that if they
are validated in the clinic, they will have much broader commercial
applications for other pharma companies across multiple disease
indications.”
Mr. Sapirstein added, “We are very impressed
with the potential of Data Vault’s IP portfolio – some of which has
been historically validated across multiple sectors and most
recently in the Data Vault-WisA Technologies transaction, where
other Data Vault IP not included in the Proposed Transaction was
acquired. FotoDigm IP that was recently issued has a broad scope
and has been cited by major IT and healthcare players as
references. We are confident that the two assets have the potential
to advance the state of the art in clinical trial monitoring and
compliance and could create a commercial opportunity with pharma
and biotech companies in the industry.”
The Company’s use of the compliance platform
would enable Entero Therapeutics to demonstrate the potential
effectiveness and commercial scalability for incorporation in new
software applications for a wide range of clinical-trial compliance
across multiple therapeutic indications. Under the terms of the
Letter of Intent, Entero Therapeutics would assume responsibility
for all future clinical trial and commercial development in this
sector and would be exclusively authorized to out-license to third
parties within. The potential licensing agreement would include an
activation triggered upon a capital infusion through strategic
investment in Entero Therapeutics, and access to capital,
technology and out-licensing within the biopharmaceutical field.
The solution has been designed to assist with Entero Therapeutics’
completion of its medical trials in the present and future. The
Letter of Intent also provides for a right of first refusal for
Entero Therapeutics to fully-acquire the QOLPOM® and FotoDigm®
assets from Data Vault Holdings, subject to certain conditions as
set forth in the Letter of Intent.
QOLPOM® and FotoDigm® were developed by the late
and Honorable Arizona State Senator David Bradley, a behavioral
healthcare administrator and the father of Data Vault Holdings’
Chief Executive Officer. QOLPOM® (Quality of Life and Peace of
Mind) was developed to solve critical behavioral problems within
the remote patient monitoring space leveraging machine learning and
IoT sensory capabilities. FotoDigm® is a patented machine vision
technology (U.S. patent number 11,437,139 Method and Apparatus for
Biometric Data Collection Combing Visual Data with Historical
Health Records Metadata) and has been cited by AT&T, Medtronic,
Indiana University and Express Scripts amongst others. A second
patent (U.S. patent number 12,040,088 issued on Jul 16, 2024)
includes foundational and expanded claims and a platform designed
to reduce the costs and streamline processes of data collection,
verification on a highly scalable and replicable technology for
clinical trial data management.
The terms of the Proposed Transaction are
subject to a number of contingencies, including the completion of
customary due diligence and the negotiation and execution of
definitive agreements. Upon execution of the definitive agreement,
the completion of the transaction will be subject to, among other
pre-closing requirements, satisfaction of the conditions negotiated
therein, receipt of the Strategic Investment on terms satisfactory
to Entero Therapeutics, and receipt of all third-party (including
governmental) approvals, licenses, consents, and clearances, as and
when applicable. There can be no assurance that the Proposed
Transaction will be completed on the terms contemplated in the
Letter of Intent or otherwise.
About Entero Therapeutics,
Inc.Entero Therapeutics is a clinical-stage
biopharmaceutical company specializing in the development of
targeted, non-systemic therapies for gastrointestinal (GI)
diseases. The Company currently has a therapeutic development
pipeline with multiple late-stage clinical programs built around
three proprietary technologies: latiglutenase, a Phase 3-ready,
potentially first-in-class, targeted, oral biotherapeutic for
celiac disease; capeserod, a selective 5-HT4 receptor partial
agonist being developed for gastroparesis; and adrulipase, a
recombinant lipase enzyme designed to enable the digestion of fats
and other nutrients in cystic fibrosis and chronic pancreatitis
patients with exocrine pancreatic insufficiency. Entero
Therapeutics is headquartered in Boca Raton, Florida. For more
information visit www.enterothera.com.
About Data Vault Holdings
Inc.Data Vault Holdings thrives by strategically managing
a diverse portfolio that includes a robust patent network and
innovative ventures. Data Vault Holdings’ success stems from Data
Vault Holdings’ ability to bridge intellectual property protection
with market opportunities, driving transformative innovations
across sectors. By fostering a culture of creativity and
collaboration, Data Vault Holdings continuously redefines industry
standards and propel forward-thinking solutions that resonate
globally. Through Data Vault Holdings’ integrated approach, Data
Vault Holdings remains at the forefront of driving impactful
advancements and shaping the future of innovation. WisA
Technologies recently announced the execution of a definitive
asset purchase agreement for the purchase of Data Vault Holdings’
information technology intellectual property for its spatial audio
technology business for $210 million dollars. For more information
visit: www.datavaultholdings.com.
About Honorable Senator David
BradleyThe former Senator died of pancreatic cancer that
did as it often does, eluded early detection, a disease that can
exhibit aggressive growth that makes it one of the more
life-threatening of GI cancers. To learn more about David Bradley
visit www.senatorbradley.com.
Forward-Looking StatementsThis
press release of and by the Company may contain certain statements
relating to future results which are forward-looking statements. It
is possible that the Company’s actual results and financial
condition may differ, possibly materially, from the anticipated
results and financial condition indicated in these forward-looking
statements, depending on factors including whether a definitive
agreement for the Proposed Transaction will be entered into;
whether the Proposed Transaction, or any other contemplated
transaction, may be completed with different terms, in an untimely
manner, or not at all; whether the Company will be able to realize
the benefits of the Proposed Transaction described herein; the
Company’s current and future capital requirements and its ability
to raise additional funds to satisfy its capital needs; whether
there are delays in the engagement of a new independent registered
public accounting firm; whether there are any further delays in the
preparation and filing of the Company’s Form 10-Q; whether the
Company will be able to realize the expected benefits of its
acquisition of ImmunogenX; the Company’s ability to integrate the
assets and contemplated commercial operations acquired from
ImmunogenX into the Company’s business; whether the Company will be
able to effectively and timely service its debt; whether results
obtained in preclinical and nonclinical studies and clinical trials
will be indicative of results obtained in future clinical trials;
whether preliminary or interim results from a clinical trial will
be indicative of the final results of the trial; whether the
Company will be able to maintain compliance with Nasdaq’s continued
listing criteria and the effect of a delisting from Nasdaq on the
market for the Company’s securities; whether the Company will be
able to satisfy the terms of any plan of compliance it submits to
Nasdaq; whether Nasdaq will accept any plan of compliance the
Company submits, or provide any other accommodations to the
Company; the size of the potential markets for the Company’s drug
candidates and its ability to service those markets; and the
effects of the First Wave Bio, Inc. acquisition, the related
settlement and their effect on the Company’s business, operating
results and financial prospects. Additional information concerning
the Company and its business, including a discussion of factors
that could materially affect the Company’s financial results are
contained in the Company’s Annual Report on Form 10-K for the year
ended December 31, 2023, under the heading “Risk Factors,” as well
as the Company’s subsequent filings with the Securities and
Exchange Commission. All forward-looking statements included in
this press release are made only as of the date of this press
release, and we do not undertake any obligation to publicly update
or correct any forward-looking statements to reflect events or
circumstances that subsequently occur or of which we hereafter
become aware.
For more information:Entero Therapeutics,
Inc.777 Yamato Road, Suite 502Boca Raton, FL 33431Phone: (561)
589-7020info@enterothera.com
Media contact:Russo PartnersDavid Schull(347)
956-7697
This press release was published by a CLEAR® Verified
individual.
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