1. Jefferies London Healthcare Conference on November 18 - 19, 2021

    2021 Phage Futures Congress Europe on November 23 - 24, 2021

    NESS ZIONA, Israel, Nov. 17, 2021 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE:PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced upcoming presentations at the Jefferies London Healthcare Conference on November 18-19 and the 2021 Phage Futures Congress Europe on November 23-24.

      
    Jefferies London Healthcare Conference – November 18-19, 2021
      
    Date & Time:

    On-demand session will be available to conference attendees beginning
    Thursday, November 18, 3:00 AM EST through November 19,

    Jefferies London Healthcare Conference on November 18 - 19, 2021

    2021 Phage Futures Congress Europe on November 23 - 24, 2021

    NESS ZIONA, Israel, Nov. 17, 2021 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE:PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced upcoming presentations at the Jefferies London Healthcare Conference on November 18-19 and the 2021 Phage Futures Congress Europe on November 23-24.

      
    Jefferies London Healthcare Conference – November 18-19, 2021
      
    Date & Time:



    On-demand session will be available to conference attendees beginning

    Thursday, November 18, 3:00 AM EST through November 19, 12:00 PM EST
    Presenter: Jonathan Solomon
    Webcast Link: Link
      
    2021 Phage Futures Congress Europe – November 23-24, 2021
     
    Presentation Title:"Nebulized Bacteriophage Therapy for Chromic Pseudomonas aeruginosa

    Pulmonary Infections in CF Patients"
    Date & Time:November 23, 11:30 AM CET, 5:30 AM EST
    LocationBrussels, Beligium
    Presenter: Myriam Golembo, Ph.D.
      

    Live webcasts of the Jefferies London Healthcare Conference will be accessible through the Investors section of the Company's website at https://ir.biomx.com/news-events/ir-calendar. Following the events, the webcasts will be archived on the BiomX website.

    About BiomX Inc.

    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 cystic fibrosis, atopic dermatitis, inflammatory bowel disease, primary sclerosing cholangitis, and colorectal cancer. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets. For more information, please visit www.BiomX.com

    BiomX Contacts

    Investor Relations:

    LifeSci Advisors, LLC

    John Mullaly

    (617)-698-9253

     



    Primary Logo

    View Full Article Hide Full Article
  2. Announces Strategic Focus on Cystic Fibrosis and Atopic Dermatitis Programs Based on Potential Proof-of-Concept Clinical Data Readouts in 2022

    Cash Runway Now Extended to End of 2023, Well Beyond Key 2022 Data Readouts

    FDA Clears BiomX to Begin Phase 1b/2a Trial in Cystic Fibrosis; Trial to Start Imminently

    Company Will Host a Conference Call and Webcast Today at 8:00 am ET

    BRANFORD, Conn. and NESS ZIONA, Israel, Nov. 15, 2021 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE:PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, reported today financial results and provided a business update for the third quarter ended September 30, 2021…

    Announces Strategic Focus on Cystic Fibrosis and Atopic Dermatitis Programs Based on Potential Proof-of-Concept Clinical Data Readouts in 2022

    Cash Runway Now Extended to End of 2023, Well Beyond Key 2022 Data Readouts

    FDA Clears BiomX to Begin Phase 1b/2a Trial in Cystic Fibrosis; Trial to Start Imminently

    Company Will Host a Conference Call and Webcast Today at 8:00 am ET

    BRANFORD, Conn. and NESS ZIONA, Israel, Nov. 15, 2021 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE:PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, reported today financial results and provided a business update for the third quarter ended September 30, 2021.

    "In planning for the years ahead, BiomX has made the decision to prioritize the development of our cystic fibrosis and atopic dermatitis product candidates, as each has the potential to generate proof-of-concept clinical data readouts in 2022. BiomX will also discontinue development of its acne program," said Jonathan Solomon, Chief Executive Officer of BiomX. "We believe that by focusing on the efficient use of BiomX's capital on selected programs that can generate clinically meaningful, proof-of-concept data, will best position our company to drive value creation for shareholders. With this decision, we intend to also postpone our development efforts temporarily in inflammatory bowel disease and colorectal cancer until 2023.

    "Importantly, our new strategic focus will have a positive impact on our balance sheet. This new focus may allow us to extend our cash runway by up to 6 months, until at least the end of 2023, and additional tranches that may become available to us under our venture debt facility upon satisfaction of certain specified milestones may further extend our cash runway to the first half of 2024." We therefore believe that we remain well-positioned financially through our expected clinical data readouts in cystic fibrosis and atopic dermatitis."

    RECENT CORPORATE HIGHLIGHTS

    • In October 2021, BiomX reported topline results of the cosmetic Phase 2 acne study showing statistically significant improvement from baseline observed in the appearance of acne-prone skin but with no meaningful difference demonstrated for BX001 relative to vehicle.
    • In October 2021, BiomX entered into an agreement with Maruho Co. Ltd., Japan's largest dermatology-focused pharmaceutical company, for 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, intended primarily to support the Phase 1/2 study, of $3 million at a premium to the market share price.
    • In September 2021, BiomX was cleared by the U.S. Food and Drug Administration (FDA) to initiate a Phase 1b/2a trial of BX004 in cystic fibrosis patients with chronic respiratory infections caused by Pseudomonas aeruginosa.
    • In August 2021, the Company announced that it entered into a debt financing agreement of up to $30 million with Hercules Capital, Inc. (NYSE:HTGC). In July 2021, BiomX announced it raised $15 million in a registered direct offering of common stock and warrants.

    Clinical Program Updates

    Cystic Fibrosis ("CF") (BX004)

    • BX004 is being developed for the treatment of chronic respiratory infections caused by Pseudomonas aeruginosa, a main contributor to morbidity and mortality in patients with CF.
    • In September 2021, BX004 was cleared by the FDA to initiate a Phase 1b/2a trial in CF patients with chronic respiratory infections caused by Pseudomonas aeruginosa.
    • The Phase 1b/2a trial is composed of two parts and is expected to start imminently. Part 1 of the trial will evaluate the safety, pharmacokinetics and microbiologic/clinical activity of BX004 in eight CF patients in a single ascending dose and multiple dose design, with results expected in the second quarter of 2022. Part 2 of the trial will evaluate the safety and efficacy of BX004 in 24 CF patients randomized to a treatment or placebo cohort in a 2:1 ratio. Results from Part 2 are expected by the third quarter of 2022.

    Atopic Dermatitis ("AD") (BX005)

    • BX005 is designed to shift the skin microbiome composition of AD patients to its "pre-flare" state by reducing Staphylococcus aureusburden, potentially resulting in clinical improvement.
    • 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.

    Inflammatory Bowel Disease ("IBD") and Colorectal Cancer Programs

    • Consistent with the new strategic focus on CF and AD programs and the efficient deployment of BiomX capital, the Company plans to temporarily pause its development efforts in IBD and colorectal cancer until early 2023, as neither program would otherwise be expected to yield proof-of-concept data in patients through the end of 2022.

    Acne-Prone Skin (BX001)

    • Based upon the topline results of the cosmetic Phase 2 acne trial previously announced in October 2021, the Company has now determined that it is discontinuing this program to focus resources on the CF and AD programs.

    Third Quarter 2021 Financial Results

    • Cash balance and short-term deposits as of September 30, 2021, were $68.3 million, compared to $57.1 million as of December 31, 2020. The increase was primarily due to net cash provided by financing activities partially offset with net cash used in operating activities. During the third quarter, the Company completed a $15 million registered direct equity financing and debt financing agreement of up to $30 million. Based upon the BiomX's new strategic focus on its cystic fibrosis and atopic dermatitis programs, the Company now expects its existing cash, cash equivalents and short-term deposits to be sufficient to fund the Company's current operating plan until the end of 2023. Additional tranches that will become available to the Company under its venture debt facility upon satisfaction of certain specified milestones can further extend the Company's cash runway to the first half of 2024.
    • Research and development (R&D) expenses, net were $6.6 million for the three months ended September 30, 2021, compared to $6.1 million for the same period in 2020. The increase was primarily due to increased expenses related to conducting pre-clinical and clinical trials of our product candidates and an increase in stock-based compensation and salaries and related expenses, mainly due to the growth in the number of employees in R&D and clinical activities.
    • General and administrative expenses were $2.8 million for the three months ended September 30, 2021, compared to $2.4 million for the same period in 2020. The increase was primarily due to increases in stock-based compensation and salaries and related expenses, mainly due to the growth in the number of employees, due to an increase in expenses associated with operating as a public company, such as directors' and officers' insurance and due to expenses resulted from moving into new premises.



    • Net loss for the third quarter of 2021 was $10.0 million, compared to $8.8 million for the same period in 2020.



    • Net cash used in operating activities for the nine months ended September 30, 2021 was $18.5 million, compared to $17.3 million for the same period in 2020.

    Conference Call and Webcast Information

    BiomX management will host a conference call and webcast today at 8:00 am ET to report financial results and business updates for the third quarter 2021 ended September 30, 2021. To participate in the conference, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel), or 1-201-389-0898 (International). A live and archived webcast of the call will be available on the Investors section of the Company's website at www.biomx.com.

    About BiomX

    BiomX is a clinical-stage microbiome company developing both natural and engineered phage cocktails designed to target and destroy bacteria in the treatment of chronic diseases, such as cystic fibrosis, atopic dermatitis, inflammatory bowel disease, primary sclerosing cholangitis, 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 the sufficiency of cash, cash equivalents and short-term deposits to fund the Company's current operating plan until at least the end of 2023, or even later, the ability of its products to address unmet medical needs, the potential to receive up to $15 million in additional loan tranches if certain milestones are met, the design, aim, expected timing and results of its preclinical and clinical trials and studies, including resumption of certain development programs, as well as its pipeline and the potential of its product candidates, 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.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)

    USD in thousands, except share and per share data

     

     

     

     

    Three Months Ended

    September 30,

     

     

    Nine Months Ended

    September 30,

     

     

     

    Note

     

    2021

     

     

    2020

     

     

    2021

     

     

    2020

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development ("R&D") expenses, net

     

     

     

     

    6,608

     

     

     

    6,056

     

     

     

    16,102

     

     

     

    13,302

     

    Amortization of intangible assets

     

     

     

     

    380

     

     

     

    380

     

     

     

    1,139

     

     

     

    1,139

     

    General and administrative expenses

     

     

     

     

    2,845

     

     

     

    2,394

     

     

     

    8,436

     

     

     

    6,749

     

    Operating loss

     

     

     

     

    9,833

     

     

     

    8,830

     

     

     

    25,677

     

     

     

    21,190

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Financial expenses (income), net

     

     

     

     

    188

     

     

     

    5

     

     

     

    76

     

     

     

    248)

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Loss before tax

     

     

     

     

    10,021

     

     

     

    8,835

     

     

     

    25,753

     

     

     

    20,942

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Tax expenses

     

     

     

     

    10

     

     

     

    -

     

     

     

    16

     

     

     

    -

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net Loss

     

     

     

     

    10,031

     

     

     

    8,835

     

     

     

    25,769

     

     

     

    20,942

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Basic and diluted loss per share of Common Stock

     

    6

     

     

    0.37

     

     

     

    0.38

     

     

     

    1.03

     

     

     

    0.91

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Weighted average number of shares of Common Stock outstanding, basic and diluted

     

     

     

     

    27,077,903

     

     

     

    23,150,253

     

     

     

    25,120,037

     

     

     

    23,013,790

     



    BIOMX INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)

    USD in thousands

     

     

     

     

    As of

     

     

     

    Note

     

    September 30,

    2021

     

     

    December 31,

    2020

     

    ASSETS

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Current assets

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

     

     

     

    67,346

     

     

     

    36,477

     

    Restricted cash

     

     

     

     

    985

     

     

     

    763

     

    Short-term deposits

     

     

     

     

    -

     

     

     

    19,851

     

    Other current assets

     

     

     

     

    1,467

     

     

     

    3,576

     

    Total current assets

     

     

     

     

    69,798

     

     

     

    60,667

     

     

     

     

     

     

     

     

     

     

     

     

    Property and equipment, net

     

     

     

     

    5,863

     

     

     

    2,228

     

    Intangible assets, net

     

     

     

     

    1,899

     

     

     

    3,038

     

    Operating lease right-of-use assets

     

     

     

     

    4,239

     

     

     

    4,430

     

    Total non-current assets

     

     

     

     

    12,001

     

     

     

    9,696

     

     

     

     

     

     

    81,799

     

     

     

    70,363

     



     

     

     

     

    As of

     

     

     

    Note

     

    September 30,

    2021

     

     

    December 31,

    2020

     

     

     

     

     

     

     

     

     

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Current liabilities

     

     

     

     

     

     

     

     

    Trade account payables

     

     

     

     

    1,879

     

     

     

    2,320

     

    Other account payables

     

     

     

     

    6,321

     

     

     

    3,978

     

    Current portion of operating lease liabilities

     

     

     

     

    799

     

     

     

    863

     

    Total current liabilities

     

     

     

     

    8,999

     

     

     

    7,161

     

     

     

     

     

     

     

     

     

     

     

     

    Non-current liabilities

     

     

     

     

     

     

     

     

     

     

    Long-term debt

     

    4

      

    14,225

       

    -

     

    Operating lease liabilities, net of current portion

     

     

     

     

    4,728

     

     

     

    5,032

     

    Other liabilities

     

     

     

     

    420

     

     

     

    701

     

    Total non-current liabilities

     

     

     

     

    19,373

     

     

     

    5,733

     

     

     

     

     

     

     

     

     

     

     

     

    Commitments and Collaborations

     

    3

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Stockholders' equity

     

    5

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Preferred Stock, $0.0001 par value; Authorized - 1,000,000 shares as of September 30, 2021 and December 31, 2020. No shares issued and outstanding as of September 30, 2021 and December 31, 2020.

     

     

     

     

    -

     

     

     

    -

     

    Common Stock, $0.0001 par value; Authorized - 60,000,000 shares as of September 30, 2021 and December 31, 2020. Issued – 28,206,229 shares as of September 30, 2021 and 23,270,337 shares as of December 31, 2020. Outstanding – 28,200,529 shares as of September 30, 2021 and 23,264,637 shares as of December 31, 2020.

     

     

     

     

    3

     

     

     

    2

     

     

     

     

     

     

     

     

     

     

     

     

    Additional paid in capital

     

     

     

     

    151,451

     

     

     

    129,725

     

    Accumulated deficit

     

     

     

     

    (98,027

    )

     

     

    (72,258

    )

    Total stockholders' equity

     

     

     

     

    53,427

     

     

     

    57,469

     

     

     

     

     

     

    81,799

     

     

     

    70,363

     

    BiomX, Inc.

    Anat Primovich

    Corporate Project Manager

    +972506977228

    Source: BiomX Inc



    Primary Logo

    View Full Article Hide Full Article
  3. NESS ZIONA, Israel, Nov. 09, 2021 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE:PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that the Company will host a conference call and a live audio webcast on Monday, November 15th, 2021, at 8:00 a.m. EDT, to report third quarter 2021 financial results and provide business updates. To participate in the conference call, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel) or 1-201-389-0898 (International). The live and archived webcast will be available in the Investors section of the Company's website at www.biomx.com.

    About BiomX

    BiomX is a clinical-stage microbiome…

    NESS ZIONA, Israel, Nov. 09, 2021 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE:PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that the Company will host a conference call and a live audio webcast on Monday, November 15th, 2021, at 8:00 a.m. EDT, to report third quarter 2021 financial results and provide business updates. To participate in the conference call, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel) or 1-201-389-0898 (International). The live and archived webcast will be available in the Investors section of the Company's website at www.biomx.com.

    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.

    BiomX, Inc.

    Anat Primovich

    Corporate Project Manager

    +97250-6977227

    Media:

    LifeSci Advisors, LLC

    John Mullaly

    Source: BiomX Inc



    Primary Logo

    View Full Article Hide Full Article
  4. 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

     

    Source: BiomX Inc



    Primary Logo

    View Full Article Hide Full Article
  5. 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

     

    Investors:

    John Mullaly

    LifeSci Advisors, LLC

    (617) 429-3548



    Primary Logo

    View Full Article Hide Full Article