Company Focus and Strategy - The company is focused on developing Adrulipase, a recombinant lipase enzyme for patients with cystic fibrosis and chronic pancreatitis, while discontinuing programs for Latiglutenase, Capeserod, and Niclosamide [367]. - In March 2024, the company completed a merger with ImmunogenX, acquiring assets including Latiglutenase and CypCel, but plans to dispose of these assets within 12 months [368]. - The company has initiated a plan to dispose of the Latiglutenase program, which was aimed at treating celiac disease [375]. - The company is no longer pursuing the Niclosamide program, which included multiple Phase 2 clinical trials for various GI conditions [377]. - The company is focused on expanding its product pipeline through collaborations and acquisitions, evaluating potential asset acquisitions and business combinations [406]. Financial Performance - The net loss for the year ended December 31, 2024 was approximately $18 million, an increase of approximately $2.2 million, or 15%, over the net loss of approximately $15.8 million recorded for the year ended December 31, 2023 [415]. - Research and development expenses for the year ended December 31, 2024 totaled approximately $0.9 million, a decrease of approximately $4.1 million, or 82%, compared to $5.0 million in 2023 [409]. - General and administrative expenses for the year ended December 31, 2024 totaled approximately $14.7 million, an increase of approximately $3.9 million, or 36%, compared to $10.7 million in 2023 [411]. - Net cash used in operating activities during the year ended December 31, 2024 was approximately $9.2 million, primarily attributable to the net loss of approximately $18 million [417]. - Net cash provided by financing activities for the year ended December 31, 2024 was approximately $5.6 million, primarily due to net proceeds from the exercise of warrants and issuance of Common Stock [420]. - As of December 31, 2024, the company had cash and cash equivalents of approximately $185,000 and negative working capital of approximately $4.3 million [403]. Compliance and Agreements - The company received a letter from Nasdaq on September 6, 2024, indicating non-compliance with the minimum bid price requirement of $1.00 per share, with a compliance deadline extended to September 1, 2025 [378][379]. - A rescission agreement was announced in March 2025, which will result in the cancellation of shares and options issued during the merger, with the company retaining approximately $695,000 of IMGX's accounts payable and IMGX responsible for about $9,278,400 of secured debt [369][390]. - The company terminated its license agreement with Sanofi for Capeserod, effective April 2025, with no payments due to Sanofi [370]. - A Revolving Loan Agreement was entered into on January 31, 2025, providing $2,000,000 in loans, with an initial disbursement of $550,000 and an interest rate of 18% per annum [383]. - The company plans to conduct a Qualified Public Equity Offering of at least $5,000,000 as part of the Revolving Loan Agreement [384]. Goodwill and Stock-Based Compensation - Goodwill related to the acquisition of ProteaBio Europe SAS is approximately $1.7 million as of December 31, 2024 and 2023 [427]. - Goodwill is subject to periodic review for impairment, with judgment used to determine when events indicate potential recoverability issues [426]. - The fair value of stock-based compensation is recognized over the requisite service period, generally the vesting period [424]. Clinical Trials and Research - The company announced topline results from a Phase 2b study of Adrulipase, indicating safety and tolerability, although the primary efficacy endpoint was not achieved [374]. - The company anticipates continued increases in general and administrative expenses to support expanded research and development activities and business development efforts [401].

Core Viewpoint - Entero Therapeutics has signed a rescission agreement with all previous shareholders of ImmunogenX, which allows the company to unwind a previously announced business combination, thereby strengthening its balance sheet and refocusing its strategic initiatives [1][2]. Group 1: Rescission Agreement - The rescission agreement involves 100% of the previous shareholders of ImmunogenX and is subject to certain closing conditions, including shareholder approval by June 30, 2025 [1]. - The decision to execute the rescission agreement is aimed at providing Entero and ImmunogenX the flexibility to pursue their respective strategic initiatives while maintaining a positive working relationship [2]. Group 2: Leadership Changes - Anna Skowron has been appointed as the Chief Financial Officer of Entero effective March 3, 2025, bringing over 14 years of accounting experience and expertise in financial reporting, compliance, and corporate governance [2]. Group 3: Company Overview - Entero Therapeutics is a late clinical-stage biopharmaceutical company focused on developing targeted, non-systemic therapies for gastrointestinal diseases, addressing significant unmet needs in GI health [4]. - The company's key programs include latiglutenase for celiac disease, capeserod for gastroparesis, and adrulipase for patients with exocrine pancreatic insufficiency [4].

Company Overview - Entero Therapeutics, Inc. is a late clinical-stage biopharmaceutical company focused on developing targeted, non-systemic therapies for gastrointestinal (GI) diseases [5] - The company's programs address significant unmet needs in GI health, including latiglutenase for celiac disease, capeserod for gastroparesis, and adrulipase for patients with exocrine pancreatic insufficiency [5] Leadership Change - The board of directors has appointed Mr. Richard Paolone as the interim CEO of Entero Therapeutics [1] - Mr. Paolone is a Toronto-based securities lawyer with extensive experience in corporate finance, securities law, and mergers and acquisitions [2] - He has a reputation as a trusted advisor to management teams and boards, ensuring legal and regulatory compliance while facilitating business growth [3]

BOCA RATON, Fla., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Entero Therapeutics, Inc. (Nasdaq: ENTO) (“Entero” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that it has secured a $2 million revolving loan agreement and subsequently appointed three new members to its Board of Directors. As a condition for the loan, Entero replaced three of five members of its Board of Directors with ...

NEW YORK, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Monteverde & Associates PC (the “M&A Class Action Firm”), has recovered millions of dollars for shareholders and is recognized as a Top 50 Firm by ISS Securities Class Action Services Report. We are headquartered at the Empire State Building in New York City and are investigating Entero Therapeutics, Inc. (NASDAQ: ENTO), relating to the proposed merger with Journey Therapeutics, Inc. Under the terms of the agreement, the shareholders of Journey will acquire 99% o ...

Financial Position - Entero Therapeutics reported stockholders' equity of $881,960 as of June 30, 2023, which was below the $2.5 million minimum requirement for Nasdaq listing compliance [176]. - Nasdaq provided Entero a compliance period until March 5, 2025, to regain compliance with the minimum bid price requirement of $1.00 per share [179]. - The company had cash and cash equivalents of approximately $0.4 million as of September 30, 2024, and cumulative losses attributable to common stockholders of approximately $190.1 million [196]. - The company is subject to a Notice of Default and Acceleration regarding its Credit Agreement, with a 30-day Cure Period to address the Events of Default [186]. Mergers and Acquisitions - The company completed a merger with ImmunogenX, Inc. in March 2024, focusing on the biologic Latiglutenase for celiac disease treatment [169]. - Entero initiated a plan to dispose of certain assets and liabilities of ImmunogenX, including Latiglutenase and CypCel, within 12 months of the merger [170]. - A binding term sheet was entered into with Journey Therapeutics, Inc. for the acquisition of 100% of its outstanding equity interests in exchange for 99% of the company's fully-diluted equity [190]. Capital Raising and Financing - In May 2024, Entero announced a Registered Direct Offering, raising approximately $1.1 million from the sale of 275,000 shares of Common Stock at $2.95 per share [173]. - The company received gross proceeds of approximately $4.0 million from a March 2024 Offering, which included 173,100 shares of Common Stock priced at $7.61 each [172]. - The company anticipates needing to raise substantial additional capital in the near term to fund continuing operations and satisfy existing obligations [196]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was approximately $5.61 million, primarily from registered direct offerings [223]. Operational Performance - Research and development expenses for Q3 2024 totaled approximately $0.2 million, a decrease of approximately $0.8 million, or 80%, compared to $1.0 million in Q3 2023 [204]. - General and administrative expenses for Q3 2024 totaled approximately $1.7 million, a decrease of approximately $0.7 million, or 30%, compared to $2.4 million in Q3 2023 [207]. - Total operating expenses for the three months ended September 30, 2024, decreased to $1.89 million, down 45% from $3.43 million for the same period in 2023 [208]. - Net loss for the three months ended September 30, 2024, was approximately $2.58 million, a decrease of $0.85 million or 25% compared to a net loss of approximately $3.43 million for the same period in 2023 [210]. - Research and development expenses for the nine months ended September 30, 2024, totaled approximately $0.88 million, a decrease of $2.84 million or 76% from $3.73 million for the same period in 2023 [212]. - General and administrative expenses for the nine months ended September 30, 2024, increased to approximately $13.54 million, an increase of $5.58 million or 70% compared to $7.95 million for the same period in 2023 [215]. - The increase in general and administrative expenses was primarily due to $4.0 million in non-cash financial advisor fees related to the IMGX acquisition [216]. - Net cash used in operating activities for the nine months ended September 30, 2024, was approximately $9.05 million, compared to $8.94 million for the same period in 2023 [221]. - Loss from discontinued operations for the nine months ended September 30, 2024, was $2.0 million, representing expenses related to a disposal group classified as held for sale [218]. - Income tax benefit of approximately $10.6 million was recorded in the nine months ended September 30, 2024, due to the release of a portion of the valuation allowance in connection with the IMGX Merger [217]. - Total cash decrease for the nine months ended September 30, 2024, was approximately $3.34 million, compared to an increase of $1.93 million for the same period in 2023 [221]. Strategic Initiatives - Entero is exploring strategic alternatives for its Niclosamide program, which is currently under a non-binding term sheet for potential sale [171]. - The company has paused development of non-essential research and development activities and is exploring strategic alternatives, including a potential sale or merger [183]. - The company is exploring various potential strategies, including raising capital and restructuring indebtedness, but there is no assurance these efforts will be successful [196]. Employment and Consulting - As of December 31, 2023, Entero had 9 employees, which increased to 15 after the merger, but was later reduced to 11 employees in July 2024 [180]. - The company entered into a consulting agreement with former CEO James Sapirstein, paying $400 per hour for services rendered [181].

Merger and Acquisitions - The company announced the closing of a merger with ImmunogenX, Inc. on March 13, 2024, which is expected to enhance its therapeutic pipeline for celiac disease [420][425]. - The merger involved the issuance of 36,830 shares of Common Stock and 11,777.418 shares of Series G Preferred Stock to IMGX stockholders [426]. - The merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes [425]. - The company has agreed to hold a stockholders' meeting to approve the conversion of Series G Preferred Stock into Common Stock [429]. Clinical Trials and Product Development - The company plans to enter Phase 3 clinical trials for its Latiglutenase program in the first half of 2025 after a successful End-of-Phase 2 meeting with the FDA [421]. - The Adrulipase program aims to provide a non-animal derived therapy for exocrine pancreatic insufficiency, with a Type C meeting with the FDA planned for 2024 to discuss next steps [422]. - The Capeserod program, in-licensed from Sanofi, is expected to initiate a Phase 2 clinical development program for pediatric ulcerative colitis or gastroparesis [423]. - The company is no longer actively pursuing two Phase 2 clinical programs of Niclosamide formulations for COVID-19 GI infections and ulcerative proctitis [424]. Financial Performance - As of September 30, 2023, IMGX reported total stockholders' equity of $3,278,805, up from $881,960 as of June 30, 2023 [445]. - IMGX has not generated any revenue from product sales to date, but plans to seek revenue from product sales and other sources in the future [459]. - Research and development expenses for the year ended December 31, 2023 totaled approximately $5.0 million, a decrease of approximately $3.8 million, or 43%, compared to approximately $8.8 million for the year ended December 31, 2022 [477]. - General and administrative expenses for the year ended December 31, 2023 totaled approximately $10.7 million, a decrease of approximately $1.3 million, or 10%, compared to approximately $12.0 million for the year ended December 31, 2022 [480]. - The net loss for the year ended December 31, 2023 totaled approximately $15.8 million, an increase of approximately $1.2 million, or 8%, over the net loss of approximately $14.6 million recorded for the year ended December 31, 2022 [483]. - Net cash used in operating activities during the year ended December 31, 2023 was approximately $12.4 million, primarily attributable to the net loss of approximately $15.8 million [484]. Funding and Financing - The company has entered into a non-binding term sheet to sell its Niclosamide program, which includes a low seven-figure upfront payment and future milestone economics, expected to close in the first half of 2024 [421]. - IMGX entered into secured promissory notes totaling $1 million with shareholders Jack Syage and Peter Felker, maturing on October 13, 2025 [443]. - The company raised aggregate gross proceeds of approximately $4.0 million from a March 2024 Registered Direct Offering [468]. - The company expects to incur substantial expenditures for the development of product candidates, including Latiglutenase, Adrulipase, Capeserod, and Niclosamide, and will require additional financing to support these efforts [470]. - The company is focused on expanding its product pipeline through collaborations and acquisitions, and may raise additional equity capital or incur additional debt to finance such acquisitions [471]. Compliance and Regulatory Matters - The company received a letter of reprimand from Nasdaq for failing to comply with listing requirements, but no delisting action is deemed appropriate [447]. - The company’s ability to issue securities is subject to market conditions and is currently restricted by the "baby shelf rules" due to its public float being below $75.0 million [473]. - IMGX's research and development expenses consist of personnel-related costs, fees to third parties, and costs associated with clinical trials and product development [460]. - The company has entered into agreements to reduce the exercise price of Series B Warrants to $1,050.00 per share for certain holders [458]. - IMGX's stockholders ratified the entry into a July Offering, which required prior shareholder approval due to compliance issues [447].

Clinical Development - The company is focused on developing gut-restricted GI clinical drug candidates, including adrulipase and niclosamide [333]. - Adrulipase is designed to treat exocrine pancreatic insufficiency in cystic fibrosis and chronic pancreatitis patients, with topline data from a Phase 2b trial expected in Q3 2023 [334]. - The company completed enrollment in the FW-COV trial for COVID-19 GI infections in January 2022, but decided to discontinue this program due to mixed results [336]. - The company expects research and development expenses to increase as it focuses on late-stage clinical trials for product candidates niclosamide and adrulipase [357]. - The company anticipates general and administrative expenses to increase to support expanded research and development activities and business development efforts [361]. Financial Performance - The company reported a stockholders' deficit of $(6,969,988) as of September 30, 2021, failing to meet Nasdaq's minimum stockholders' equity requirement of $2.5 million [342]. - The net loss for the year ended December 31, 2022 totaled approximately $14.6 million, a decrease of approximately $43.9 million, or 75%, compared to the net loss of approximately $58.5 million for the year ended December 31, 2021 [380]. - The company has not generated any revenues and has experienced net losses and negative cash flows from its activities to date [362]. - The total operating expenses for the year ended December 31, 2022 were approximately $12.7 million, a decrease of approximately $46.4 million compared to $59.1 million for the year ended December 31, 2021 [372]. Cash Flow and Funding - As of December 31, 2022, the company had cash and cash equivalents of approximately $1.4 million and working capital of approximately $0.8 million [363]. - The company raised approximately $4.0 million from a private placement in March 2023 to support its operations [363]. - The company is dependent on obtaining additional funding from outside sources to continue its operations and may not achieve profitability [363]. - Net cash used in operating activities for the year ended December 31, 2021 was approximately $32.3 million, primarily due to a net loss of approximately $58.5 million, adjusted for non-cash expenses of approximately $9.7 million [382]. - Net cash provided by financing activities for the year ended December 31, 2022 was approximately $15.7 million, primarily from the issuance of common stock under the ATM Agreement for net proceeds of approximately $7.7 million [385]. Expenses Overview - Research and development expenses for the year ended December 31, 2022 totaled approximately $8.8 million, a decrease of approximately $8.2 million, or 48%, compared to $17.0 million for the year ended December 31, 2021 [374]. - General and administrative expenses for the year ended December 31, 2022 totaled approximately $12.0 million, a decrease of approximately $6.4 million, or 35%, compared to $18.4 million for the year ended December 31, 2021 [376]. Stock and Goodwill - A 1-for-30 reverse stock split was completed on August 26, 2022, to regain compliance with Nasdaq's bid price rule [344]. - The carrying value of goodwill was approximately $1.7 million and $1.9 million at December 31, 2022 and 2021, respectively, with a loss of approximately $1.7 million recognized related to foreign translation adjustments during the year ended December 31, 2022 [393]. - The company recognized an impairment charge of approximately $2.4 million on patents acquired in the Mayoly APA during the year ended December 31, 2021 [390].