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
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
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
In the event the Company closes the potential transaction with ImmunogenX,
We believe this possibility, on its own, offers the potential to substantially enhance the value of
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
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.
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
2024 has the potential to be a year of significant growth for
Sincerely,
Chairman and CEO
About
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
For more information:
Phone: (561) 589-7020
info@firstwavebio.com
Media contact:
(609) 468-9325
dschemelia@tiberend.com
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2024 GlobeNewswire, Inc., source