BiomX Announces Agreement with Maruho Co., Ltd. for Atopic Dermatitis Product Candidate BX005

Rhea-AI Summary

BiomX (NYSE: PHGE) has entered a licensing agreement with Maruho Co. Ltd., granting Maruho the right of first offer for BX005, a product targeting atopic dermatitis, set to begin after Phase 1/2 trial results in 2022. Additionally, Maruho will invest $3 million in BiomX, supporting the ongoing study. BX005 aims to combat Staphylococcus aureus to improve skin microbiome health. BiomX’s innovative phage-based approach highlights its potential in addressing dermatological issues. The announcement marks a significant collaboration in one of the largest dermatology markets.

Positive

• Maruho Co. Ltd. granted a right of first offer for BX005, indicating strong interest in a major market.
• Maruho's $3 million equity investment supports BiomX's Phase 1/2 study, enhancing financial position.

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• None.

BRANFORD, Conn. and NESS ZIONA, Israel, Oct. 13, 2021 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage microbiome company advancing novel natural and engineered phage cocktails that target specific pathogenic bacteria, 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.

“We thank Maruho for its investment in BiomX and support of our atopic dermatitis program,” said Jonathan Solomon, Chief Executive Officer of BiomX. “As the leading dermatology company in Japan, Maruho has built exceptional therapeutic capabilities and expertise that could support the success of BX005 in Japan. Interest from a closely-aligned and strong partner like Maruho for one of the world’s largest dermatology markets supports the science behind our phage-based approach of targeting bacteria associated with disease exacerbation.”

The securities described herein have not been registered under the Securities Act of 1933, as amended, and may not be sold in the United States absent registration or an applicable exemption from the registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

About BX005
BX005 is BiomX’s topical phage product candidate targeting Staphylococcus aureus (S. aureus), a bacterium associated with the development and exacerbation of inflammation in atopic dermatitis. By reducing S. aureus burden, BX005 is designed to shift the skin microbiome composition to its baseline state to potentially result in clinical improvement. Results from a Phase 1/2 proof-of-concept trial evaluating the safety and efficacy of BX005 in atopic dermatitis patients are expected in the first half of 2022.

About BiomX
BiomX is a clinical-stage microbiome company developing both natural and engineered phage cocktails designed to target and destroy bacteria that affect the appearance of skin, as well as target bacteria in the treatment of chronic diseases, such as inflammatory bowel disease, primary sclerosing cholangitis, cystic fibrosis, atopic dermatitis and colorectal cancer. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets. Additional information is available at www.biomx.com, the content of which does not form a part of this press release.

About Maruho
Maruho Co., Ltd. has its headquarters in Osaka and leads Japan in research and development, manufacturing and commercialization of dermatological products. Founded in 1915, Maruho has 1,542 employees (as of the end of September 2020), and net sales were approximately 80.34 billion yen in its fiscal year ended September 30, 2020. Pursuing its long-term corporate vision of “Excellence in Dermatology,” Maruho is striving to improve the health and quality of life of people all over the world.
For more information, please visit https://www.maruho.co.jp/english/.

Forward-Looking Statements
This press release contains express or implied “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. For example, when BiomX discusses timing of expected availability of results from its phase 2 study of BX005 and potential success of such trial and the Atopic Dermatitis program, the future of the business relationship between BiomX and Maruho, and, in particular, whether such parties will enter into a license or other agreement relating to BX005, BiomX is making forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on BiomX management’s current beliefs, expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of BiomX control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Except as otherwise required by law, BiomX undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Therefore, investors should not rely on any of these forward-looking statements and should review the risks and uncertainties described under the caption “Risk Factors” in BiomX’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2021, BiomX’s Quarterly Report on Form 10-Q filed with the SEC on August 16, 2021 and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC’s website at www.sec.gov. Forward-looking statements are made as of the date of this press release, and except as provided by law BiomX expressly disclaims any obligation or undertaking to update forward-looking statements.

BiomX, Inc.
Assaf Oron
Chief Business Officer
+972 (54) 222-8901
assafo@biomx.com  

Investors:
John Mullaly
LifeSci Advisors, LLC
(617) 429-3548
jmullaly@lifesciadvisors.com

FAQ

What is the significance of Maruho's investment in BiomX?

Maruho's $3 million investment supports BiomX's clinical development of BX005, a product for atopic dermatitis.

What does the right of first offer granted to Maruho mean for BiomX?

It allows Maruho the first option to license BX005 after Phase 1/2 study results, indicating confidence in the product.

When are the results of the Phase 1/2 study for BX005 expected?

The results for BX005's Phase 1/2 study are anticipated in the first half of 2022.

What does BX005 target in treating atopic dermatitis?

BX005 specifically targets Staphylococcus aureus, a bacterium linked to inflammation in atopic dermatitis.