June 2024
CORPORATE PRESENTATION
(NASDAQ:ENTO)
Targeted, Non-Systemic Therapeutics for Gastrointestinal Diseases
www.enterothera.com
Company Disclaimer
This presentation ("the Presentation") 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.
This Presentation does not constitute an offer to sell, or the solicitation of an offer to buy, any securities of the
Company in any jurisdiction, domestic or foreign, where the offer, solicitation or sale is not permitted or would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
© Entero Therapeutics www.enterothera.com | |
Confidential; Not for Distribution | 2 |
- First Wave BioPharma Merger with ImmunogenX
- Business Combination Creates A Best-In-Class, Late- Stage Pipeline of Targeted, Non-Systemic Therapeutics for Gastrointestinal Diseases
- Latiglutenase Therapeutic for Celiac Disease to be Advanced to Phase 3 Clinical Trial
(NASDAQ:ENTO)
www.enterothera.com
Entero Therapeutics: A Merger of First Wave and ImmunogenX
Focused on GI Indications
- Business Combination: Strong Strategic Fit
- First Wave BioPharma (NASDAQ:FWBI) and privately-held ImmunogenX (IMGX)
- GI pipeline expansion into Celiac Disease with a Phase 3-ready asset
- Merged company has four gut-targeted,late-stage GI assets
- Robust pipeline to address key unmet medical needs afflicting millions of patients in multi-billion dollar markets
- Transaction
- 100% equity transaction
- Non-bindingcommitment for significant financial investment from a strategic biopharmaceutical company in exchange for commercial rights to latiglutenase
- Potential financing commitments from several institutional investors
- Synergistic Integration of Management Teams
- FWBI: Operational, financial and commercial expertise
- IMGX: Scientific, clinical and regulatory affairs expertise
- Core competence in development of recombinant digestive enzymes
© Entero Therapeutics www.enterothera.com | |
Confidential; Not for Distribution | 4 |
Overview: GI Company with multiple late-stage clinical assets
Entero Therapeutics is a clinical stage biotechnology company currently focused on the development of targeted, non-systemic therapies for gastrointestinal diseases
LATIGLUTENASE
CAPESEROD
ADRULIPASE
Recombinant enzyme; dual-protease biologic for the treatment of Celiac Disease (CeD)
- Targeting symptom relief and quality of life (QOL) improvements
- Phase 3 clinical trial initiation anticipated in 2025
Re-purposed selective 5-HT4 receptor partial agonist for gastrointestinal indications, including gastroparesis
- Asset in-licensed from Sanofi
- Phase 2 Gastroparesis trial initiation anticipated in 2025
Recombinant enzyme; lipase biologic for the treatment of Exocrine Pancreatic Insufficiency (EPI)
- EPI in Cystic Fibrosis (CF) and Chronic Pancreatitis (CP)
- Phase 2 Bridging Study topline data 2H'23; FDA Type-C meeting to be requested 1H'24
Robust IP portfolio covering method, formulation and use indications; key patents secure for 15-20 years
Pipeline of gut-targeted GI therapies address significant unmet medical needs in billion-dollar markets
© Entero Therapeutics www.enterothera.com | |
Confidential; Not for Distribution | 5 |
Entero Therapeutics Management Team
Combined Experience in Developing and Launching more than 25 Drugs
James Sapirstein
Chairman & Chief Executive Officer
- Led Gilead's launch of Tenofovir/ Viread
- Director of BMS International Infectious Disease Group
- Founder of Tobira, sold to Allergan for $1.7B
Jack Syage, Ph.D.
President & Chief Scientific Officer
- Serial entrepreneur, closed four acquisitions
- >30 years developing innovative technologies
- 140 publications, 80 invited talks, 30 U.S. patents, Fellow of the American Physical Society, Tibbetts Award (SBIR), OC 500
Sarah Romano
Chief Financial Officer
Martin Krusin
SVP Corporate Development
© Entero Therapeutics www.enterothera.com | |
Confidential; Not for Distribution | 6 |
Entero GI Clinical Pipeline (2023-2028)
Indications | 2023 | 2024 | 2025 | 2026 | 2027 | 2028 | |||
Latiglutenase | • | Celiac Disease | Phase 3 | Phase 3 | BLA | ||||
Dosing | Safety | ||||||||
Capeserod | • | Gastroparesis | |||||||
Phase 2* | |||||||||
Adrulipase | • | EPI in CF | Phase | ||||||
• | EPI in CP | ||||||||
2b | |||||||||
Niclosamide** | • | Multiple Phase 2 | |||||||
All Indications Phase 2 ready | |||||||||
Indications*** | |||||||||
- Subject to FDA IND review
- A non-binding term sheet has been signed for the sale of Niclosamide
- Ulcerative Proctitis/Proctosigmoiditis, Ulcerative Colitis, ICI-AC, Pouchitis, Crohn's Disease
© Entero Therapeutics www.enterothera.com | |
Confidential; Not for Distribution | 7 |
LATIGLUTENASE
Celiac Disease
www.enterothera.com
Latiglutenase: A First-to Market Opportunity in Celiac Disease
- Latiglutenase, a targeted Celiac Disease therapeutic to provide symptom relief and Quality of Life improvements, with first-to-market opportunity
- Addressing an unmet clinical need in a multi-billion dollar market, there are no commercially available therapies for Celiac Disease
- Compelling endpoint data from Phase 2 trials and solid FDA support
- Strong Peer Review Support - $7.7MM in NIH grants
- FDA Successful End-of-Phase 2 Meeting completed
- FDA Support for Phase 3 Trial Endpoints and Fast Track Designation
- FDA Agrees with Initial Pediatric Study Plan
- Phase 3 Trial initiation anticipated 1H'2025; market entry 2H'2027
© Entero Therapeutics www.enterothera.com | |
Confidential; Not for Distribution | 9 |
Celiac Disease (CeD)
Large Unmet Need, No Therapies Available
- Genetically predisposed autoimmune disease caused by eating gluten; a protein found in wheat, barley, and rye
- ~1% of the world's population1
- ~3.3 million patients in the US alone
- Chronic and debilitating gastrointestinal problems and other long-term health issues
- Only current treatment is a gluten-free diet (GFD) which is impractical and often ineffective
- CeD patients typically consume 100's of mg/day of gluten where <50 mg/day is considered safe2
- Patients live in fear that a trace amount of gluten can unexpectedly trigger a painful and debilitating flare-up
- 73% of CeD patients have exposure to gluten and symptoms once a year despite being on a GFD3
- Nearly 40% of CeD patients reported accidentally ingesting gluten as often as 1-5 times month with over two-thirds having severe GI symptoms3
- P Singh, A Arora, Tor Strand, et al. Global Prevalence of Celiac Disease: Systematic Review and Meta-analysis. Clinical Gastroenterology and Hepatology. March 15, 2018 DOI: https://doi.org/10.1016/j.cgh.2017.06.03
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J A Syage, C.P Kelly, M A Dickason, A Cebolla-Ramirez, F Leon, R Dominguez, J A Sealey-Voyksner, Determination of Gluten Consumption in Celiac Disease Patients on a Gluten-Free Diet. Am. J. Clin. Nutr.,
107, 201-207 (2018) - https://www.beyondceliac.org/celiac-news/73-percent-still-exposed-gluten/
© Entero Therapeutics www.enterothera.com | |
Confidential; Not for Distribution | 10 |
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Entero Therapeutics Inc. published this content on 12 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 June 2024 13:38:04 UTC.