Latest news with #BiomX
Business Upturn
19-05-2025
- Business
- Business Upturn
BiomX CEO Jonathan Solomon to Present at Biomed Israel 2025 Conference
NESS ZIONA, Israel, May 19, 2025 (GLOBE NEWSWIRE) — BiomX Inc. (NYSE American: PHGE) ('BiomX' or the 'Company'), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that Jonathan Solomon, Chief Executive Officer, will present at the Biomed Israel 2025 conference, reviewing the Company's topline Phase 2 results for BX211 in DFO. The conference is being held between May 20 – 22, 2025, in Tel Aviv, Israel. Presentation Details Oral Presentation Title Precision Phage Therapy for Chronic Diabetic Foot Infections Session Immunology & Inflammation; Reclaim Top Priorities in BioPharma: Driver and Opportunities? Session Time/Location: May 21, 2025, 12:15 – 2:15 pm IST, Hall A, InterContinental David Tel Aviv 'Leading the innovation of phage therapies, BiomX's programs target persistent, antibiotic-resistant infections in chronic diseases that can result in devastating impacts, including substantially increased morbidity and mortality, for patients,' said Jonathan Solomon, Chief Executive Officer of BiomX. 'At Biomed Israel, the premier biopharma conference in the region, we have the opportunity to showcase the positive topline Phase 2 results for our BX211 program in DFO associated with Staphylococcus aureus . We are grateful for key opinion leader endorsements we've received and to the organizations that have provided vital support for this program, and we look forward to presenting our BX211 Phase 2 findings at an upcoming, peer-reviewed scientific forum.' BX211 Topline Phase 2 Trial Results Available: Here About BX211 BX211 is a phage treatment for the treatment of DFO associated with S. aureus . DFO is a bacterial infection of the bone that usually develops from an infected foot ulcer and is a leading cause of amputation in patients with diabetes. In March 2025, BiomX announced positive topline results from the Phase 2 trial in which BX211 was demonstrated to be safe and well-tolerated and patients receiving BX211 exhibited statistically significant1 and sustained reduction of ulcer size (PAR)(p = 0.046 at week 12; p=0.052 at week 13), with a separation from placebo starting at week 7 and a difference greater than 40% by week 10. In addition, BX211 also produced statistically significant1 improvements in both ulcer depth at week 13 (in patients with ulcer depth defined as bone at baseline, ulcer depth was classified according to deepest tissue involved as measured by swab) (p=0.048), and in reducing the expansion of ulcer area (p=0.017). Over the 12-week treatment period, all patients (treatment and placebo) were treated in accordance with standard of care, including with systemic antibiotic therapy as appropriate. BiomX is currently planning a Phase 2/3 trial, pending discussions and feedback from the Food and Drug Administration ('FDA'). About BiomX BiomX is a clinical-stage company leading the development of natural and engineered phage cocktails and personalized phage treatments designed to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs. BiomX discovers and validates proprietary bacterial targets and applies its BOLT ('BacteriOphage Lead to Treatment') platform to customize phage compositions against these targets. For more information, please visit 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 refers to its anticipated timing of its future clinical trials as well as the design thereof, expected discussions with the FDA and other regulatory authorities and results thereof, and the potential of its candidates to address the substantial unmet needs of patients with intractable infections, it is using 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's control. These risks and uncertainties include, but are not limited to, changes in applicable laws or regulations; the possibility that BiomX may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in BiomX's drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials, BiomX's ability to enroll patients in its clinical trials, and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the FDA and other regulatory authorities; decisions made by investigational review boards at clinical trial sites and publication review bodies with respect to our development candidates; BiomX's ability to obtain, maintain and enforce intellectual property rights for its platform and development candidates; its potential dependence on collaboration partners; competition; uncertainties as to the sufficiency of BiomX's cash resources to fund its planned activities for the periods anticipated and BiomX's ability to manage unplanned cash requirements; and general economic and market conditions. 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 25, 2025, and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC's website at 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. Contacts: BiomX, CohenHead Corporate Communications [email protected]
Associated Press
19-05-2025
- Business
- Associated Press
BiomX CEO Jonathan Solomon to Present at Biomed Israel 2025 Conference
NESS ZIONA, Israel, May 19, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) ('BiomX' or the 'Company'), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that Jonathan Solomon, Chief Executive Officer, will present at the Biomed Israel 2025 conference, reviewing the Company's topline Phase 2 results for BX211 in DFO. The conference is being held between May 20 - 22, 2025, in Tel Aviv, Israel. Presentation Details 'Leading the innovation of phage therapies, BiomX's programs target persistent, antibiotic-resistant infections in chronic diseases that can result in devastating impacts, including substantially increased morbidity and mortality, for patients,' said Jonathan Solomon, Chief Executive Officer of BiomX. 'At Biomed Israel, the premier biopharma conference in the region, we have the opportunity to showcase the positive topline Phase 2 results for our BX211 program in DFO associated with Staphylococcus aureus. We are grateful for key opinion leader endorsements we've received and to the organizations that have provided vital support for this program, and we look forward to presenting our BX211 Phase 2 findings at an upcoming, peer-reviewed scientific forum.' BX211 Topline Phase 2 Trial Results Available: Here About BX211 BX211 is a phage treatment for the treatment of DFO associated with S. aureus. DFO is a bacterial infection of the bone that usually develops from an infected foot ulcer and is a leading cause of amputation in patients with diabetes. In March 2025, BiomX announced positive topline results from the Phase 2 trial in which BX211 was demonstrated to be safe and well-tolerated and patients receiving BX211 exhibited statistically significant1 and sustained reduction of ulcer size (PAR)(p = 0.046 at week 12; p=0.052 at week 13), with a separation from placebo starting at week 7 and a difference greater than 40% by week 10. In addition, BX211 also produced statistically significant1 improvements in both ulcer depth at week 13 (in patients with ulcer depth defined as bone at baseline, ulcer depth was classified according to deepest tissue involved as measured by swab) (p=0.048), and in reducing the expansion of ulcer area (p=0.017). Over the 12-week treatment period, all patients (treatment and placebo) were treated in accordance with standard of care, including with systemic antibiotic therapy as appropriate. BiomX is currently planning a Phase 2/3 trial, pending discussions and feedback from the Food and Drug Administration ('FDA'). About BiomX BiomX is a clinical-stage company leading the development of natural and engineered phage cocktails and personalized phage treatments designed to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs. BiomX discovers and validates proprietary bacterial targets and applies its BOLT ('BacteriOphage Lead to Treatment') platform to customize phage compositions against these targets. For more information, please visit 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 refers to its anticipated timing of its future clinical trials as well as the design thereof, expected discussions with the FDA and other regulatory authorities and results thereof, and the potential of its candidates to address the substantial unmet needs of patients with intractable infections, it is using 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's control. These risks and uncertainties include, but are not limited to, changes in applicable laws or regulations; the possibility that BiomX may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in BiomX's drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials, BiomX's ability to enroll patients in its clinical trials, and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the FDA and other regulatory authorities; decisions made by investigational review boards at clinical trial sites and publication review bodies with respect to our development candidates; BiomX's ability to obtain, maintain and enforce intellectual property rights for its platform and development candidates; its potential dependence on collaboration partners; competition; uncertainties as to the sufficiency of BiomX's cash resources to fund its planned activities for the periods anticipated and BiomX's ability to manage unplanned cash requirements; and general economic and market conditions. 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 25, 2025, and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC's website at 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. Contacts: BiomX, Inc. Ben Cohen Head Corporate Communications [email protected] ________________________ 1 All p-values described in this release are non-adjusted
Yahoo
19-05-2025
- Health
- Yahoo
BiomX CEO Jonathan Solomon to Present at Biomed Israel 2025 Conference
Presentation to Focus on Positive Topline Results from Phase 2 Trial Evaluating BX211 for the Treatment of Diabetic Foot Osteomyelitis (DFO) NESS ZIONA, Israel, May 19, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) ('BiomX' or the 'Company'), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that Jonathan Solomon, Chief Executive Officer, will present at the Biomed Israel 2025 conference, reviewing the Company's topline Phase 2 results for BX211 in DFO. The conference is being held between May 20 - 22, 2025, in Tel Aviv, Israel. Presentation Details Oral Presentation Title Precision Phage Therapy for Chronic Diabetic Foot Infections Session Immunology & Inflammation; Reclaim Top Priorities in BioPharma: Driver and Opportunities? Session Time/Location: May 21, 2025, 12:15 – 2:15 pm IST, Hall A, InterContinental David Tel Aviv 'Leading the innovation of phage therapies, BiomX's programs target persistent, antibiotic-resistant infections in chronic diseases that can result in devastating impacts, including substantially increased morbidity and mortality, for patients,' said Jonathan Solomon, Chief Executive Officer of BiomX. 'At Biomed Israel, the premier biopharma conference in the region, we have the opportunity to showcase the positive topline Phase 2 results for our BX211 program in DFO associated with Staphylococcus aureus. We are grateful for key opinion leader endorsements we've received and to the organizations that have provided vital support for this program, and we look forward to presenting our BX211 Phase 2 findings at an upcoming, peer-reviewed scientific forum.' BX211 Topline Phase 2 Trial Results Available: Here About BX211BX211 is a phage treatment for the treatment of DFO associated with S. aureus. DFO is a bacterial infection of the bone that usually develops from an infected foot ulcer and is a leading cause of amputation in patients with diabetes. In March 2025, BiomX announced positive topline results from the Phase 2 trial in which BX211 was demonstrated to be safe and well-tolerated and patients receiving BX211 exhibited statistically significant1 and sustained reduction of ulcer size (PAR)(p = 0.046 at week 12; p=0.052 at week 13), with a separation from placebo starting at week 7 and a difference greater than 40% by week 10. In addition, BX211 also produced statistically significant1 improvements in both ulcer depth at week 13 (in patients with ulcer depth defined as bone at baseline, ulcer depth was classified according to deepest tissue involved as measured by swab) (p=0.048), and in reducing the expansion of ulcer area (p=0.017). Over the 12-week treatment period, all patients (treatment and placebo) were treated in accordance with standard of care, including with systemic antibiotic therapy as appropriate. BiomX is currently planning a Phase 2/3 trial, pending discussions and feedback from the Food and Drug Administration ("FDA"). About BiomXBiomX is a clinical-stage company leading the development of natural and engineered phage cocktails and personalized phage treatments designed to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs. BiomX discovers and validates proprietary bacterial targets and applies its BOLT ('BacteriOphage Lead to Treatment') platform to customize phage compositions against these targets. For more information, please visit the content of which does not form a part of this press release. Safe HarborThis 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 refers to its anticipated timing of its future clinical trials as well as the design thereof, expected discussions with the FDA and other regulatory authorities and results thereof, and the potential of its candidates to address the substantial unmet needs of patients with intractable infections, it is using 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's control. These risks and uncertainties include, but are not limited to, changes in applicable laws or regulations; the possibility that BiomX may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in BiomX's drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials, BiomX's ability to enroll patients in its clinical trials, and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the FDA and other regulatory authorities; decisions made by investigational review boards at clinical trial sites and publication review bodies with respect to our development candidates; BiomX's ability to obtain, maintain and enforce intellectual property rights for its platform and development candidates; its potential dependence on collaboration partners; competition; uncertainties as to the sufficiency of BiomX's cash resources to fund its planned activities for the periods anticipated and BiomX's ability to manage unplanned cash requirements; and general economic and market conditions. 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 25, 2025, and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC's website at 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. Contacts: BiomX, CohenHead Corporate Communicationsbenc@ ________________________1 All p-values described in this release are non-adjusted
Yahoo
08-05-2025
- Business
- Yahoo
BiomX to Host First Quarter 2025 Financial Results Conference Call and Webcast on May 15, 2025
NESS ZIONA, Israel, May 08, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) ('BiomX' or the 'Company'), a clinical-stage 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 Thursday, May 15, 2025, at 2:00 p.m. ET, to report first quarter 2025 financial results and provide business and program updates. To participate in the conference call, please dial 1-877-407-0724 (U.S.) or +1 201-389-0898 (International). The live and archived webcast will be available in the Investors section of the Company's website at About BiomXBiomX is a clinical-stage company leading the development of natural and engineered phage cocktails and personalized phage treatments designed to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs. BiomX discovers and validates proprietary bacterial targets and applies its BOLT ('BacteriOphage Lead to Treatment') platform to customize phage compositions against these targets. For more information, please visit the content of which does not form a part of this press release. BiomX, CohenHead Corporate Communicationsbenc@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
31-03-2025
- Business
- Associated Press
BiomX Announces Positive Topline Results from Phase 2 Trial Evaluating BX211 for the Treatment of Diabetic Foot Osteomyelitis (DFO)
BX211 was safe and well-tolerated BX211 produced sustained and statistically significant 1 Percent Area Reduction (PAR) of ulcer size (p = 0.046 at week 12; p=0.052 at week 13) , with a separation from placebo starting at week 7 and a difference greater than 40% by week 10 Compared to placebo, BX211 also produced statistically significant 1 improvements in both ulcer depth at week 13 (in patients with ulcer depth defined as bone at baseline) (p=0.048), and in reducing the expansion of ulcer area (p=0.017). BiomX is planning for a Phase 2/3 trial of BX211, pending U.S. Food and Drug Administration (FDA) feedback The Company will host a conference call and webcast today at 9:00 AM ET, followed by a Key Opinion Leader (KOL) event on April 3, 2025, at 11:00 AM ET to discuss the results NESS ZIONA, Israel, March 31, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) ('BiomX' or the 'Company'), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced positive, topline safety and efficacy results from the Company's DFO Adaptive Novel Care Evaluation (DANCE™) Phase 2 trial evaluating its BX211 phage treatment for DFO associated with Staphylococcus aureus ( S. aureus). The findings demonstrated BX211 to be safe and well-tolerated and that patients receiving BX211 exhibited statistically significant1 and sustained reduction of ulcer size (PAR) (p = 0.046 at week 12; p=0.052 at week 13), with a separation from placebo starting at week 7 and a difference greater than 40% by week 10. In addition, BX211 also produced statistically significant1 improvements in both ulcer depth at week 13 (in patients with ulcer depth defined as bone at baseline, ulcer depth was classified according to deepest tissue involved as measured by swab) (p=0.048), and in reducing the expansion of ulcer area (p=0.017). Over the 12-week treatment period, all patients (treatment and placebo) were treated in accordance with standard of care, including with systemic antibiotic therapy as appropriate. Following the successful Phase 2 readout of BX211, the Company is planning for a Phase 2/3 trial, pending discussions and feedback from the U.S Food and Drug Administration. 'We believe these data represent one of the strongest demonstrations to date of the therapeutic potential of phage therapy. We are grateful to all the patients who participated, and the treating teams who enrolled patients into the study, as well as the continued and ongoing support from the U.S. Defense Health Agency (DHA) for this program,' said Jonathan Solomon, BiomX's Chief Executive Officer. 'Today, 30-40% of DFO cases lead to lower extremity amputations related to serious bacterial infections, accounting for the majority of the 160,000 lower limb amputations in diabetic patients each year in the United States. Based on the results announced today, we believe BiomX's novel phage therapy approach has the potential to help address the major unmet need in DFO. Moreover, in an era of modern conflict and rising antibiotic-resistant wounds, the need for innovative wound care solutions underscores the broader relevance of this program beyond DFO. BiomX is dedicated to the advancement of phage therapy, which we believe holds promise in redefining the treatment of chronic infections.' 'Phage therapy has a critical role to play in treating infections where antibiotic resistance has emerged or existing treatments have underperformed,' said Dr. Robert T. 'Chip' Schooley, M.D., Distinguished Professor of Medicine, Division of Infectious Diseases and Global Public Health and Co-Director, Center for Innovative Phage Applications and Therapeutics at the University of California, San Diego. 'The promising topline data in this trial provide an important inflection point for this approach and its potential to address the most challenging infections.' 'Diabetic foot infections are often a complex and difficult-to-treat consequence of diabetes, leading to serious adverse effects on patient quality of life,' said Dr. Benjamin A. Lipsky, M.D., FACP, FIDSA, FRCP (London), FRCPS (Glasgow), Professor of Medicine Emeritus at University of Washington, Seattle. 'The most serious and feared complication of DFO is lower extremity amputation, which is associated with a five-year mortality rate of about 50%. With the progress seen so far and given the improved ulcer healing seen in this study, BX211 may have the potential to reduce amputations. BX211 is a program to watch closely as it progresses into more advanced clinical studies.' Summary of Phase 2 BX211 Results BiomX's Phase 2 trial is a randomized, double-blind, placebo-controlled, multi-center study investigating the safety, tolerability, and efficacy of BX211 for individuals with DFO associated with S. aureus. The study enrolled a total of 41 patients randomized for treatment at a 2:1 ratio, 26 of whom received intravenous (IV) and topical administration of BX211 on week 1 followed by a topical weekly dose through week 12, while 15 patients were assigned to the placebo arm. Over the 12-week treatment period, all subjects (treatment and placebo) were also treated in accordance with standard of care, including with systemic antibiotic therapy as appropriate. A readout of study results at week 13 evaluated healing of the wound associated with osteomyelitis. The primary efficacy endpoint was PAR of study ulcer through week 13. Study design was guided in part by experience with numerous compassionate cases using phage therapy for the treatment of DFO and osteomyelitis. The topline Phase 2 results included: BX211 was found to be safe and well-tolerated. BX211 produced sustained and statistically significant 1 PAR of ulcer size (p = 0.046 at week 12; p=0.052 at week 13) , with a separation from placebo (standard of care) starting at week 7 and a difference greater than 40% by week 10. BX211 produced statistically significant 1 improvements in both ulcer depth at week 13 (in patients with ulcer depth defined as bone at baseline) (p=0.048), and in reducing the expansion of ulcer area (p=0.017), compared to placebo. BX211 demonstrated favorable trends compared to placebo across several additional clinical parameters, including: proportion of visits with no clinical evidence of infection; evidence of resolving DFO by MRI/X-ray at week 12; proportion of patients with abnormal C-Reactive Protein at baseline that achieved a reduction of CRP of at least 50% at any point in the study; and greater Wagner scale improvement 2. Through week 13, BX211 demonstrated comparable efficacy against both Methicillin-susceptible and resistant strains, as well as against high and low biofilm producers—consistent with the orthogonal mechanism of phage therapy to antibiotics and its inherent anti-biofilm capabilities. BiomX expects to present additional data from the Phase 2 study at upcoming scientific conferences. Today's Conference Call and Webcast Information BiomX management will host a conference call and webcast today at 9:00 AM ET to review the topline Phase 2 trial results, accompanied by a slide deck presentation, which will be available on the Company's website and filed via Form 8-K. To participate in the conference, please dial +877-407-0724 (U.S.), or +1 201-389-0898 (International), or click on the webcast link here. A live and archived webcast of the call will also be available on the Investors section of the Company's website at BiomX to Host Virtual KOL Event – April 3, 2025 The Company has scheduled a virtual KOL Event to discuss the topline results from the Phase 2 trial. The event will take place on April 3, 2025, at 11:00 am ET, and will include participation from BiomX senior management and two KOLs, Dr. Robert T. 'Chip' Schooley, M.D., Distinguished Professor of Medicine, Division of Infectious Diseases and Global Public Health and Co-Director, Center for Innovative Phage Applications and Therapeutics at the University of California, San Diego, and Dr. Benjamin A. Lipsky, M.D., FIDSA, FRCP (London), FRCPS (Glasgow) Professor of Medicine Emeritus at University of Washington, Seattle. To register for the event, please click here. About BX211 BX211 is a phage treatment for the treatment of DFO associated with S. aureus. DFO is a bacterial infection of the bone that usually develops from an infected foot ulcer and is a leading cause of amputation in patients with diabetes. Pending feedback from the FDA, BiomX is planning for a Phase 2/3 clinical trial of BX211. About BiomX BiomX is a clinical-stage company leading the development of natural and engineered phage cocktails and personalized phage treatments designed to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs. BiomX discovers and validates proprietary bacterial targets and applies its BOLT ('BacteriOphage Lead to Treatment') platform to customize phage compositions against these targets. For more information, please visit 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 refers to the potential safety and toleration of BX211, the potential benefits of BX211, future clinical development of BX211 and the relevance and potential of phage therapy in the treatment of chronic infections, it is using 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's control. These risks and uncertainties include, but are not limited to, changes in applicable laws or regulations; the possibility that BiomX may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in BiomX's drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials, BiomX's ability to enroll patients in its clinical trials, and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the FDA and other regulatory authorities; investigational review boards at clinical trial sites and publication review bodies with respect to our development candidates; BiomX's ability to obtain, maintain and enforce intellectual property rights for its platform and development candidates; its potential dependence on collaboration partners; competition; uncertainties as to the sufficiency of BiomX's cash resources to fund its planned activities for the periods anticipated and BiomX's ability to manage unplanned cash requirements; and general economic and market conditions. 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 25, 2025, and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC's website at 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. Contacts: BiomX Inc. Ben Cohen 2 The Wagner Scale is a clinical grading system used to classify the severity of diabetic foot ulcers, ranging from 0 (intact skin) to 5 (extensive gangrene).
