BX005 / BiomX, Maruho - LARVOL DELTA

A Study of Topical BX005-A in Subjects With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: BiomX, Inc. | Phase classification: P1b/2a ➔ P1/2 | N=48 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Phase classification • Trial withdrawal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Comprehensive evaluation of Pinellia ternata germplasm resources based on phenotypic trait classification (PubMed, Zhongguo Zhong Yao Za Zhi) - "BX007, BX008, and BX005 were identified as germplasms with both high yield and high uridine content, with BX007 having the highest uridine content of 479.51 μg·g~(-1). It belonged to the germplasm of P. ternata with double bulbils and could be cultivated as a potential good variety. Based on the phenotypic classification of P. ternata, systematic resource evaluation was carried out in this study, which could lay a foundation for the excavation of genetic resources and the breeding of new varieties of P. ternata."

Journal

BiomX Reports Second Quarter 2023 Financial Results and Provides Business Update (GlobeNewswire) - "Research and development ('R&D') expenses, net were $3.8 million for the three months ended June 30, 2023, compared to $4.6 million for the same period in 2022. The decrease was primarily attributed to reduced salaries and related expenses and stock-based compensation expenses that resulted from a reduction in workforce, as part of a corporate restructuring the Company announced in May 2022 (the 'Corporate Restructuring'); as well as deprioritizing pre-clinical and clinical activities related to the Company’s AD product candidate, BX005, and higher proceeds from collaboration agreements in the 2023 period."

Commercial • Atopic Dermatitis • Immunology

BiomX Reports First Quarter 2023 Financial Results and Provides Business Update (GlobeNewswire) - "Second and Final Closing of PIPE Investment Completed, Raising Total Gross Proceeds of $7.5 million; Cash Runway into the Third Quarter of 2024....Research and development ('R&D') expenses, net were $4.6 million for the three months ended March 31, 2023, compared to $4.9 million for the same period in 2022. The decrease was primarily due to reduced salaries and related expenses and stock-based compensation expenses that resulted from a reduction in workforce...as well as deprioritizing pre-clinical and clinical activities related to our AD product candidate, BX005, partially offset by expenses related to conducting the Phase 1b/2a clinical trial of our CF product candidate, BX004."

Commercial • Atopic Dermatitis • Cystic Fibrosis • Immunology

BiomX Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update (BioSpace) - "Research and development ('R&D') expenses, net were $16.2 million for the year ended December 31, 2022, compared to $22.7 million for the prior year. The decrease was primarily due to a decrease in salaries and related expenses and stock-based compensation expenses due to a reduction in workforce, as a result of a corporate restructuring; as well as discontinuing pausing the development of BX003, our product candidate for inflammatory bowel disease and delaying the development of BX005, our product candidate for atopic dermatitis."

Commercial • Atopic Dermatitis • Immunology • Inflammatory Bowel Disease

BiomX Reports Third Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - "BiomX Inc...reported today financial results and provided a business update for the third quarter ended September 30, 2021....BX005 is currently in the final stages of GMP production. Due to delays in communications with the FDA attributable to COVID-related matters, the Company now expects results from its Phase 1/2 proof-of-concept trial evaluating the safety and efficacy of BX005 in the third quarter of 2022 instead of the first half of 2022."

P1/2 data • Atopic Dermatitis • Immunology

BiomX Announces Agreement with Maruho Co., Ltd. for Atopic Dermatitis Product Candidate BX005 (GlobeNewswire) - "BiomX Inc...announced today that it has entered into an agreement granting Maruho Co. Ltd., a leading dermatology-focused pharmaceutical company in Japan, a right of first offer to license BiomX’s atopic dermatitis product candidate, BX005, in Japan. The right of first offer will commence following the availability of results from the Phase 1/2 study of BX005 expected in 2022. Maruho also entered into a binding agreement for an equity investment in BiomX of $3 million at a premium to the market share price, intended primarily to support the Phase 1/2 study."

Licensing / partnership • New P1/2 trial • Atopic Dermatitis • Dermatology • Immunology