PHGE BiomX Inc.

2.28
-0.08  -3%
Previous Close 2.36
Open 2.35
52 Week Low 2.0752
52 Week High 9.0495
Market Cap $64,283,633
Shares 28,194,576
Float 24,817,361
Enterprise Value $26,784,036
Volume 59,049
Av. Daily Volume 107,107
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Upcoming Catalysts

Drug Stage Catalyst Date
BX005
Atopic dermatitis
Phase 1/2
Phase 1/2
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BX003
Inflammatory Bowel Disease and Primary Sclerosing Cholangitis
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
BX001
Acne
Phase 2
Phase 2
Phase 2 demonstrated to be safe and well-tolerated, with no treatment-related adverse events. A statistically significant improvement from baseline was observed in the appearance of acne-prone skin but no meaningful difference was demonstrated relative to vehicle. Over 80% of subjects dosed reported reduction in skin redness and tenderness of skin bumps, indicated that the product left skin hydrated and noticeably improved the feel of their skin, noted October 18, 2021.

Latest News

  1. 12-Week Study of BX001 Meets Safety and Tolerability Endpoints

    Statistically Significant Improvement from Baseline Observed in Appearance of Acne-prone Skin but No Meaningful Difference Demonstrated Relative to Vehicle

    Subject Satisfaction Questionnaire Outcomes Indicate Preference for BX001 Over Vehicle on Key Parameters

    BRANFORD, Conn. and NESS ZIONA, Israel, Oct. 18, 2021 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE:PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage cocktails that target specific pathogenic bacteria, today announced results from its Phase 2 cosmetic clinical study assessing the potential of BX001 to improve the appearance of skin in acne prone subjects. BX001 was…

    12-Week Study of BX001 Meets Safety and Tolerability Endpoints

    Statistically Significant Improvement from Baseline Observed in Appearance of Acne-prone Skin but No Meaningful Difference Demonstrated Relative to Vehicle

    Subject Satisfaction Questionnaire Outcomes Indicate Preference for BX001 Over Vehicle on Key Parameters

    BRANFORD, Conn. and NESS ZIONA, Israel, Oct. 18, 2021 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE:PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage cocktails that target specific pathogenic bacteria, today announced results from its Phase 2 cosmetic clinical study assessing the potential of BX001 to improve the appearance of skin in acne prone subjects. BX001 was demonstrated to be safe and well-tolerated, with no treatment-related adverse events. A statistically significant improvement from baseline was observed in the appearance of acne-prone skin but no meaningful difference was demonstrated relative to vehicle.

    "Today we report topline results from our vehicle controlled, Phase 2 cosmetic acne study," said Jonathan Solomon, Chief Executive Officer of BiomX. "Compared to our prior Phase 1 trial, this study enrolled significantly more subjects and tested BX001 over a longer application period, so we were pleased to see that BX001 maintained an excellent safety and tolerability profile. However, we are disappointed that BX001 did not demonstrate a meaningful differentiation from vehicle on efficacy. We will further evaluate the data from this study before communicating potential next steps for the BX001 development program."

    "BiomX continues to maintain a diversified pipeline targeting different pathogenic bacteria addressing areas of high unmet need. For the months ahead, we continue to look forward to reporting additional clinical milestones, including data readouts in our cystic fibrosis, atopic dermatitis, and inflammatory bowel disease programs."

    The Phase 2 cosmetic clinical study in acne was a 12-week randomized, single center, double-blind, placebo-controlled trial in 140 women with mild-to-moderate acne vulgaris. Subjects were randomized into two cohorts: BX001 or placebo (vehicle) in a 1:1 ratio with BX001 or placebo self-administered twice daily. The key endpoints evaluated the safety, tolerability, and efficacy of BX001.

    Significant improvements in the appearance of acne prone skin, as assessed by reduction in inflammatory lesion counts (48.3%, p<0.0001), non-inflammatory lesion counts (36.3%, p<0.0001), and reduction in mean Investigator's Global Assessment (IGA) score (-0.29, p<0.001), were observed when compared to baseline for both cohorts. No meaningful difference was demonstrated for BX001 relative to vehicle.

    Subject satisfaction reported outcomes indicate preference for BX001 over vehicle in key parameters. Over 80% of subjects using BX001 reported reduction in skin redness and tenderness of skin bumps, indicated that the product left skin hydrated and noticeably improved the feel of their skin.

    About BX001

    BX001 is a topical gel formulation of a cocktail of naturally-occurring phage designed to improve the appearance of acne-prone skin by targeting Cutibacterium acnes (C. acnes), which are bacteria implicated in the pathophysiology of acne vulgaris. BX001 has been shown in vitro to be active on antibiotic resistant C. acnes strains and that it does not target other, potentially beneficial, bacteria on the skin. Furthermore, BX001 has been shown in vitro to penetrate biofilms, a matrix secreted by the bacteria which surrounds them and makes them less accessible to substances such as antibiotics. Biofilms exist in the pilosebaceous unit, where undesirable C. acnes are found.

    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.

    Safe Harbor

    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. 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 its expectations regarding further evaluation of the data from the BX001 study, determining and communicating potential next steps for the BX001 development program and the timing of reporting additional clinical milestones, and to the extent such results are positive, including data readouts in its cystic fibrosis, atopic dermatitis and inflammatory bowel disease programs, 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. 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 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  

    Source: BiomX Inc



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  2. BRANFORD, Conn. and NESS ZIONA, Israel, Oct. 13, 2021 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE: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…

    BRANFORD, Conn. and NESS ZIONA, Israel, Oct. 13, 2021 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE: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



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