First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma”
or the “Company”), a clinical-stage biopharmaceutical company
specializing in the development of targeted, non-systemic therapies
for gastrointestinal (GI) diseases, today announced that James
Sapirstein, Chairman and CEO of First Wave BioPharma, has issued a
Letter to Stockholders highlighting the Company’s recent
accomplishments and plans for 2024. The full text of the letter
follows.
A MESSAGE FROM OUR CHAIRMAN AND CHIEF
EXECUTIVE OFFICER
To my fellow stockholders,
Strong Strategic Rationale and
Operational Fit for Anticipated Business Combination with
ImmunogenX
The close of 2023 has been an exciting period
for First Wave BioPharma, highlighted by the recently announced
potential business combination with ImmunogenX. We recently
announced a non-binding term sheet with ImmunogenX and are
currently in negotiations for a definitive agreement. In the event
this potential transaction is completed, we will gain access to
Phase 3-ready latiglutenase, a potentially first-in-class,
targeted, oral biotherapeutic for celiac disease, and a team of
visionary scientists led by Jack Syage, Ph.D., who is expected to
become our President and Chief Operating Officer, and Professor
Chaitan Khosla, who completed the seminal work leading to the
discovery of latiglutenase at Stanford University.
Any definitive agreement with respect to the
potential transaction and completion of the transaction would be
subject to approval by the respective parties to that definitive
agreement, including approval by our board of directors and/or
stockholders, approval by ImmunogenX’s stockholders, various
regulatory approvals, and the combined company having sufficient
capital to carry out the planned businesses.
Concurrent Strategic Pharma Commercial
Agreement and Institutional Investment Anticipated in
1H’24
Additionally, in the event the Company closes
the potential ImmunogenX transaction, we would expect to
concurrently announce a significant non-dilutive financial
investment from a strategic global pharmaceutical company for
commercial rights to latiglutenase in the United States and Canada,
as well as financing commitments from several institutional
investors to fund the drug’s development. These expected
investments are based on the potential of latiglutenase to be a
first-to-market treatment for celiac disease, a GI-disorder that
impacts approximately three million people in the U.S. and for
which no approved pharmacologic treatment currently exists.
Latiglutenase: A Phase 3 Ready Asset for
Celiac Disease Addressing a Major Unmet Clinical Need
The Phase 3 clinical development plan for
latiglutenase has been reviewed by the GI Division of the U.S. Food
and Drug Administration (FDA), with initiation of the Phase 3
trials expected in the second half of 2024. This timing could
enable latiglutenase to enter the multibillion-dollar celiac
disease market by 2027.
In the event the Company closes the potential
transaction with ImmunogenX, First Wave BioPharma could become a
Phase 3 company with a drug technology that, upon successful
completion of the trials and approval by the FDA, could be
first-to-market for a GI disease that impacts millions of people
and where no approved therapy exists.
We believe this possibility, on its own, offers
the potential to substantially enhance the value of First Wave
BioPharma for our stockholders given the numerous development and
regulatory milestones expected with the latiglutenase program in
2024 and beyond, in the event the Company closes the potential
transaction with ImmunogenX. But it is not the only substantial
growth opportunity for our company.
Capeserod: A Phase 2 Asset Licensed from
Sanofi with Applications in Multi-Billion Dollar GI
Indications
Prior to our discussions with ImmunogenX, we
strengthened our GI-focused pipeline with the addition of
capeserod, a selective 5-HT4 receptor partial agonist, from Sanofi.
Artificial intelligence (AI)-empowered analyses indicate the drug’s
prokinetic mechanism of action has potential applications for
several gastrointestinal disorders in multibillion-dollar markets,
such as gastroparesis, where there are significant unmet clinical
needs and no commercially available therapies without serious side
effects. Based on these analyses and buoyed by capeserod’s strong
safety profile, we are moving rapidly to initiate Phase 2 clinical
trials in 2024 and will be liaising with the FDA to establish the
best developmental and regulatory pathway forward.
Niclosamide: Streamlining Our Clinical
Pipeline
In late December, we announced the signing of a
non-binding term sheet to sell our niclosamide inflammatory bowel
disease (IBD) program to an undisclosed biopharmaceutical company.
The non-binding term sheet includes a low seven-figure payment to
First Wave BioPharma along with economics related to future
milestones and royalties.
We believe niclosamide has potential as a
non-steroidal anti-inflammatory therapy for the treatment of
mild-to-moderate IBDs. However, we made the strategic decision to
streamline our development pipeline following the in-licensing of
Phase 2-ready capeserod from Sanofi and the pending addition of
Phase 3-ready latiglutenase. If completed, we believe this
transaction would allow us to focus our development efforts on
those assets, while providing the potential to infuse our company
with additional, non-dilutive capital.
First Wave BioPharma: A Diversified
Late-Stage Clinical Portfolio with Three GI Assets
In the event the Company closes the potential
transaction with ImmunogenX, latiglutenase and capeserod will
headline a late-stage GI pipeline that is unrivaled by other
companies of similar size to First Wave. Add to that, ongoing
analyses of the adrulipase Phase 2 data have been promising and
suggest potential opportunities to advance the program. We plan to
request a meeting with the FDA in Q1’2024 to discuss the data and a
clinical development plan given the shortcomings with current
treatments for exocrine pancreatic insufficiency in patients with
cystic fibrosis and chronic pancreatitis. For
our stockholders…
This is a very exciting time in the growth and
evolution of First Wave BioPharma, and we are working diligently to
advance our multiple, late-stage development programs to bring
relief to patients living daily with the often painful, dangerous
and discomforting symptoms inherent to gastrointestinal
disease.
2024 has the potential to be a year of significant growth for
First Wave BioPharma, and once again, I thank all of our
stockholders for your continued support.
Sincerely,James SapirsteinChairman and CEOFirst
Wave BioPharma, Inc.
About First Wave BioPharma,
Inc.
First Wave BioPharma is a clinical-stage
biopharmaceutical company specializing in the development of
targeted, non-systemic therapies for gastrointestinal (GI)
diseases. The Company is currently advancing a therapeutic
development pipeline with multiple late-stage clinical programs
built around three proprietary technologies – capeserod, a
selective 5-HT4 receptor partial agonist which First Wave will
develop for gastrointestinal (GI) indications; the biologic
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; and niclosamide, an oral small molecule with
anti-inflammatory properties for patients with inflammatory bowel
diseases such as ulcerative colitis and Crohn’s disease. First Wave
BioPharma is headquartered in Boca Raton, Florida. For more
information visit www.firstwavebio.com.
Forward-Looking Statements
This press release 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
the sale of niclosamide, the potential transaction with ImmunogenX
and any concurrent financing or licensing 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 transactions described
herein; the Company’s ability to integrate the assets and
commercial operations contemplated to be acquired from ImmunogenX
into the Company’s business; whether the closing conditions can be
met or the definitive agreements can be executed for the sale of
niclosamide, the transaction with ImmunogenX, any concurrent
financing or licensing transaction, or any other contemplated
transaction, 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; the size of the potential markets for the
Company’s drug candidates and its ability to service those markets;
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; and the Company’s current and
future capital requirements and its ability to raise additional
funds to satisfy its capital needs. 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, 2022, 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:First Wave BioPharma,
Inc.777 Yamato Road, Suite 502Boca Raton, FL 33431Phone: (561)
589-7020info@firstwavebio.com
Media contact:Tiberend Strategic Advisors,
Inc.David Schemelia(609) 468-9325dschemelia@tiberend.com
First Wave BioPharma (NASDAQ:FWBI)
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