Core Insights - BiomX announced positive topline results from the Phase 2 trial of BX211 for diabetic foot osteomyelitis, indicating significant progress in their clinical pipeline [1][2] - The company is preparing for a Phase 2/3 trial of BX211 pending FDA feedback and anticipates topline results for BX004 in cystic fibrosis in Q1 2026 [4][6] Clinical Program Updates - BX211 demonstrated safety and significant reduction in ulcer size with a p-value of 0.046 at week 12 and 0.052 at week 13, showing over 40% improvement by week 10 compared to placebo [3][12] - Statistically significant improvements were also observed in ulcer depth and area expansion, with p-values of 0.048 and 0.017 respectively [3][12] - The program has received approximately $40 million in non-dilutive funding from the U.S. Defense Health Agency to address antibiotic-resistant infections [2] Business Update - Shareholders approved the exercise of warrants related to $12 million in financing, providing operational runway into Q1 2026 [6] - The company’s cash balance increased to $21.2 million as of March 31, 2025, up from $18.0 million at the end of 2024, primarily due to recent financings [7] Financial Results - Research and development expenses rose to $5.3 million in Q1 2025 from $4.1 million in Q1 2024, driven by preparations for clinical trials [8] - General and administrative expenses decreased to $2.5 million in Q1 2025 from $2.7 million in Q1 2024 [9] - The net loss for Q1 2025 was $7.7 million, a significant reduction from $17.3 million in Q1 2024, attributed to changes in the fair value of warrants [10][25]

Core Viewpoint - BiomX Inc. is set to host a conference call on May 15, 2025, to discuss its first quarter 2025 financial results and provide updates on its business and programs [1]. Company Overview - BiomX is a clinical-stage company focused on developing natural and engineered phage therapies aimed at targeting and eliminating specific pathogenic bacteria [3]. - The company utilizes its proprietary BOLT ("BacteriOphage Lead to Treatment") platform to customize phage compositions against validated bacterial targets [3].

Group 1: Stock Performance and Technical Analysis - Shares of BiomX Inc. (PHGE) have lost 7.9% over the past two weeks, but a hammer chart pattern formed in the last trading session suggests potential support and a possible trend reversal [1] - The hammer pattern indicates a nearing bottom with potential exhaustion of selling pressure, which is supported by rising optimism among Wall Street analysts regarding the company's future earnings [2][7] - The hammer chart pattern is characterized by a small candle body and a long lower wick, signaling that bears may have lost control over the price during a downtrend [4][5] Group 2: Earnings Estimates and Analyst Ratings - There has been a 34.9% increase in the consensus EPS estimate for the current year over the last 30 days, indicating that sell-side analysts expect better earnings than previously predicted [8] - PHGE currently holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9] - The positive trend in earnings estimate revisions is a bullish indicator that may lead to price appreciation in the near term [7][9]

Financial Data and Key Metrics Changes - BioMx reported a strong start to the year with total gross proceeds of approximately $12 million from financing activities, which will support the completion of the Phase 2b study of BX004 in cystic fibrosis patients [25][26] - The company anticipates that the funds will provide adequate runway to reach the readout of top line Phase 2b results expected in the first quarter of 2026 [25] Business Line Data and Key Metrics Changes - The Phase II trial of BX211 for treating staphylococcus aureus infections in patients with diabetic foot osteomyelitis (DFO) showed statistically significant results across several key parameters, marking a significant advancement in phage therapy [7][23] - The study involved 41 patients, with a randomized two-to-one ratio of control to treatment group, demonstrating a greater than 40% reduction in ulcer size by week 10 for the BX211 treatment group [16][18] Market Data and Key Metrics Changes - In the U.S., there are over 38 million individuals diagnosed with diabetes, leading to approximately 400,000 diabetic foot infection ER visits annually and around 160,000 lower limb amputations in diabetic patients [11] - The total financial burden on the U.S. healthcare system due to diabetic amputations is approximately $8 billion annually, highlighting the substantial unmet need in this market [11] Company Strategy and Development Direction - BioMx aims to address the unmet needs of patients with chronic diseases through customized stage therapies, focusing on the development of BX004 and BX211 [6][7] - The company is exploring real-world evidence in cystic fibrosis to understand the relationship between Pseudomonas aeruginosa reduction and clinical outcomes, preparing for regulatory discussions later this year [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the positive Phase II results for BX211, viewing it as a watershed moment for phage therapy and a potential game changer in managing DFO and diabetic foot infections [7][23] - The management highlighted the importance of continued support from investors and partners, including the Defense Health Agency, which is interested in phage therapy due to its potential in treating drug-resistant infections [33][34] Other Important Information - BioMx will host a virtual event on April 3 featuring key opinion leaders in bacteriophage therapy to discuss the implications of the Phase II trial results for BX211 [27][28] - The company emphasized the safety of phage therapy, noting no significant differences in severe adverse events between the phage and placebo groups [60] Q&A Session Summary Question: Potential for additional non-dilutive capital from various sources - Management indicated ongoing support from the Defense Health Agency, which has been funding the company significantly, especially in light of drug-resistant infections observed in returning troops [33][34] Question: Insights on patient demographics and natural disease progression - The patient population in the study was typical for DFO, with a median age around 60 and a significant portion facing amputation, highlighting the unmet need [37][39] Question: Thoughts on the control arm's performance - The control arm's performance was consistent with expectations, hovering around a 40% improvement, which aligns with historical data for similar patient populations [39][58] Question: Early learnings regarding dosing regimens - Management noted that while it is still early to draw conclusions, the gradual response observed in this study may differ from previous studies in cystic fibrosis, suggesting that delivery methods and infection geography play significant roles [42][44] Question: Phase III study expectations and regulatory designations - Management acknowledged it is early to define Phase III study parameters but expressed excitement about the data quality and potential regulatory consultations to strategize the best path forward [46] Question: Specific adverse events related to phage treatment - Management confirmed that no significant differences in severe adverse events were observed between the phage and placebo groups, reinforcing the safety profile of phage therapy [60] Question: Plans for publication or presentation of data - Management is consulting with key opinion leaders to determine the best context for publishing the data, emphasizing the significance of the findings [62]

Core Viewpoint - BiomX Inc. has disclosed a going concern qualification in its audit opinion for the fiscal year ended December 31, 2024, as required by NYSE regulations [1] Company Overview - BiomX is a clinical-stage company focused on developing natural and engineered phage therapies aimed at targeting and eliminating harmful bacteria associated with chronic diseases that have significant unmet medical needs [2] - The company utilizes its BOLT ("BacteriOphage Lead to Treatment") platform to customize phage compositions against proprietary bacterial targets [2]

Core Viewpoint - BiomX Inc. announced positive topline safety and efficacy results from its Phase 2 trial of BX211, a phage therapy for diabetic foot osteomyelitis (DFO) associated with Staphylococcus aureus, indicating significant potential in addressing unmet medical needs in this area [1][2][3]. Summary of Phase 2 BX211 Results - The Phase 2 trial was a randomized, double-blind, placebo-controlled study involving 41 patients, with a treatment ratio of 2:1, where 26 received BX211 and 15 received placebo [4]. - BX211 was found to be safe and well-tolerated, showing a statistically significant reduction in ulcer size (Percent Area Reduction, PAR) with p-values of 0.046 at week 12 and 0.052 at week 13, with a notable separation from placebo starting at week 7 and a difference greater than 40% by week 10 [3][12]. - Statistically significant improvements were also observed in ulcer depth at week 13 (p=0.048) and in reducing the expansion of ulcer area (p=0.017) compared to placebo [12]. - The study demonstrated favorable trends across additional clinical parameters, including evidence of resolving DFO by MRI/X-ray and improvement in the Wagner scale [12]. Future Plans - Following the successful Phase 2 results, BiomX plans to initiate a Phase 2/3 trial of BX211, pending feedback from the U.S. Food and Drug Administration (FDA) [1][9]. - The company will present additional data from the Phase 2 study at upcoming scientific conferences [5]. Industry Context - The results highlight the therapeutic potential of phage therapy, particularly in treating infections where antibiotic resistance is a concern, addressing a significant unmet need in DFO, which currently leads to a high rate of lower extremity amputations [2][12]. - The company emphasizes the broader relevance of phage therapy in modern conflict scenarios and rising antibiotic-resistant infections, indicating a shift in treatment paradigms for chronic infections [2].

Phage Therapy Development - The company is developing phage-based therapies targeting harmful bacteria associated with chronic diseases, with a focus on cystic fibrosis (CF) and diabetic foot osteomyelitis (DFO) [23]. - BX004, a therapeutic phage product candidate for chronic pulmonary infections caused by Pseudomonas aeruginosa, has shown positive results in a Phase 1b/2a trial, with a mean reduction of -1.42 log CFU at Day 15 compared to -0.28 log in the placebo group [32]. - In Part 2 of the Phase 1b/2a trial, 14.3% of patients treated with BX004 converted to sputum culture negative for P. aeruginosa after 10 days, compared to 0% in the placebo group [37]. - BX004 received Fast Track designation from the FDA in August 2023 and orphan drug designation in December 2023 [34]. - The company plans to initiate a Phase 2b study for BX004 in CF patients in Q2 2025, enrolling approximately 60 patients [35]. - BX211, a phage therapy for DFO associated with Staphylococcus aureus, is currently in a Phase 2 study with topline results expected in Q1 2025 [40]. - The company has paused development of its personalized phage therapy for prosthetic joint infections to prioritize CF and DFO programs [44]. Manufacturing and Technology - The BOLT platform enables agile development of phage cocktails optimized for characteristics such as broad host range and biofilm penetration [49]. - The PST platform allows screening of extensive phage libraries to identify optimal phage for specific bacterial targets [50]. - The company has developed proprietary assays and screening technology for robust and high throughput testing, combining automation with advanced microbiology assays [54]. - The company operates a manufacturing model that combines in-house process development and testing with the flexibility to outsource to third-party organizations when needed [58]. - The company has consolidated its U.S. GMP manufacturing into a 6,500 square feet facility in Ness Ziona, Israel, designed for early-stage clinical development [56]. Intellectual Property - The patent portfolio includes 7 issued or allowed patents and 19 patent families from the acquisition of APT, with expiration dates ranging from June 2037 to October 2043 [65]. - The company solely owns two patent families directed to pharmaceutical compositions for treating chronic Pseudomonas lung infections, expected to expire in 2042 [66]. - The company plans to continue expanding its intellectual property estate by filing patent applications related to formulations and methods of treatment [61]. Regulatory Environment - The FDA must make a decision on accepting a Biologics License Application (BLA) for filing within 60 days of receipt, with a standard review period of 10 months and 6 months for priority review [90]. - The FDA may conduct a pre-approval inspection of manufacturing facilities to ensure compliance with current Good Manufacturing Practices (cGMP) before approving a BLA [91]. - Clinical trials are conducted in three phases, with Phase 1 focusing on safety and tolerability, Phase 2 on proof of concept and dosing, and Phase 3 on effectiveness and safety in a larger patient population [82][88]. - An Investigational New Drug (IND) application must be submitted to the FDA before human clinical trials can begin, and it becomes effective 30 days after receipt unless the FDA raises concerns [80]. - The FDA's fast-track program expedites the review process for drugs intended to treat serious conditions and demonstrates potential to address unmet medical needs [95]. - Orphan drug designation does not shorten the regulatory review process but provides opportunities for grant funding and user-fee waivers [94]. Financial Overview - APT has an accumulated deficit of $180.7 million as of December 31, 2024, and expects to incur significant losses for the foreseeable future [178]. - For the years ended December 31, 2024 and 2023, APT reported losses from operations of $44.5 million and $25.3 million, respectively [179]. - APT has cash, cash equivalents, and restricted cash of $18 million as of December 31, 2024 [180]. - APT entered into an At the Market Offering Agreement with H.C. Wainwright & Co. for an aggregate offering price of up to $7.5 million [180]. Market and Competitive Landscape - The biotechnology industry is characterized by strong competition, with competitors having greater financial and technical resources [72]. - The company intends to pursue commercialization of its drug product candidates through internal sales and marketing capabilities or collaborations [76]. - The company faces uncertainty regarding coverage and reimbursement for its products, as cosmetics are generally not eligible for coverage in the U.S. [151]. - Third-party payors are increasingly challenging the pricing and cost-effectiveness of medical products, which may require the company to conduct expensive clinical trials [154]. Risks and Challenges - The company is subject to significant legal risks related to fraud and abuse laws, which may result in civil, criminal, and administrative penalties, potentially impacting operations and financial results [141]. - The company anticipates that future healthcare reform measures may limit government payments for healthcare products, potentially reducing demand and increasing pricing pressures [150]. - The company has experienced challenges in enrolling patients for clinical trials, particularly in the DFO phase 2 study, which could affect trial outcomes and costs [211]. - Delays in clinical trials could result in unmet developmental milestones and increased costs, impacting regulatory approval timelines [214]. - The company must continue to develop manufacturing processes, and any delays could harm clinical trial timelines and business operations [222].

Financial Performance - BiomX reported a net loss of $17.7 million for the year ended December 31, 2024, a decrease from a net loss of $26.2 million in 2023, primarily due to changes in the fair value of warrants[16]. - The company reported an operating loss of $44.523 million in 2024, compared to a loss of $25.348 million in 2023, reflecting a 75.6% increase in losses[26]. - Net loss for the year was $17.727 million in 2024, down from $26.169 million in 2023, indicating a 32.5% improvement[26]. - Basic loss per share decreased to $1.47 in 2024 from $5.10 in 2023, a reduction of 72.8%[26]. - Diluted loss per share also improved to $3.36 in 2024, compared to $5.10 in 2023, a decrease of 34.1%[26]. - Loss before tax improved to $17.714 million in 2024 from $26.146 million in 2023, a 32.8% decrease in losses[26]. Cash and Funding - Cash balance and restricted cash as of December 31, 2024, were $18.0 million, up from $15.9 million as of December 31, 2023, reflecting funds raised in March 2024 financing[9]. - BiomX's cash, cash equivalents, and short-term deposits are estimated to be sufficient to fund operations into the first quarter of 2026[9]. - BiomX completed a financing round in February 2025, generating approximately $12 million in gross proceeds to support ongoing clinical trials[3]. - Total non-dilutive funding received for the BX211 Phase 2 trial has reached $36.8 million, including a milestone payment from the U.S. Defense Health Agency[6]. Research and Development - Research and development expenses for 2024 were $24.7 million, an increase from $16.7 million in 2023, driven by preparations for Phase 2b clinical trials and increased expenses related to the Phase 2 trial of BX211[10]. - Research and development (R&D) expenses increased to $24.663 million in 2024 from $16.698 million in 2023, representing a 47.5% increase[26]. General and Administrative Expenses - General and administrative expenses rose to $11.8 million in 2024 from $8.7 million in 2023, attributed to the consolidation of expenses following the acquisition of Adaptive Phage Therapeutics[11]. - General and administrative expenses rose to $11.776 million in 2024, up from $8.650 million in 2023, a 36.8% increase[26]. Impairments - The company reported an impairment of $0.8 million in goodwill for the year ended December 31, 2024, following the acquisition of Adaptive Phage Therapeutics[12]. - The company incurred a goodwill impairment of $801 million in 2024, with additional impairments totaling $7.283 million for IPR&D and long-lived assets[26]. Clinical Trials - Topline results for the Phase 2 trial of BX211 in diabetic foot osteomyelitis (DFO) are expected by the end of March 2025[6]. - The company anticipates topline results from the Phase 2b study of BX004 in cystic fibrosis patients in the first quarter of 2026[8]. Interest Expenses - Interest expenses decreased to $873 thousand in 2024 from $2.404 million in 2023, a reduction of 63.7%[26]. Share Information - The weighted average number of shares used for computing basic loss per share increased significantly from 5,133,093 in 2023 to 12,019,401 in 2024 due to a reverse share split[26].

Core Insights - BiomX Inc. reported financial results for Q4 and full year 2024, highlighting progress in clinical trials and financing activities [1][6][5] - The company is finalizing the analysis of topline results from the Phase 2 trial of BX211, with results expected by the end of March 2025 [2][7] - BiomX completed a financing round in Q1 2025, generating $12 million in gross proceeds to support ongoing clinical trials and regulatory discussions [2][5] Clinical Program Updates - BX211 is being evaluated for the treatment of diabetic foot osteomyelitis (DFO) associated with Staphylococcus aureus, with topline results expected by the end of March 2025 [3][7] - BX004 is a fixed phage cocktail targeting cystic fibrosis patients with chronic pulmonary infections caused by Pseudomonas aeruginosa, with topline results anticipated in Q1 2026 [4][15] Financial Performance - As of December 31, 2024, the cash balance was $18 million, an increase from $15.9 million in 2023, primarily due to funds raised in March 2024 [6] - Research and development expenses for 2024 were $24.7 million, up from $16.7 million in 2023, driven by preparations for clinical trials and increased operational costs [9] - The net loss for 2024 was $17.7 million, a decrease from $26.2 million in the prior year, attributed to changes in the fair value of warrants [13] Business Update - BiomX entered into a securities purchase agreement in February 2025, raising approximately $12 million to fund its clinical studies [5] - The company expects to have sufficient funding to reach significant milestones, including topline results for BX004 in Q1 2026 [5][8] Impairments and Expenses - Goodwill impairment for 2024 was $0.8 million, and in-process research and development impairment was $3.2 million, both resulting from the acquisition of Adaptive Phage Therapeutics [11][12] - General and administrative expenses increased to $11.8 million in 2024 from $8.7 million in 2023, mainly due to the consolidation of expenses following the acquisition [10]

Company Overview - BiomX Inc. is a clinical-stage company focused on developing novel natural and engineered phage therapies targeting specific pathogenic bacteria [1][3] - The company utilizes its BOLT ("BacteriOphage Lead to Treatment") platform to customize phage compositions against proprietary bacterial targets [3] Financial Results Announcement - BiomX will report its fourth quarter and full year 2024 financial results on March 25, 2025 [1] - A press release with the results will be available in the Investors section of the company's website [2] - The company plans to host a conference call and live audio webcast to discuss the financial results and initial topline results from its Phase 2 trial for diabetic foot osteomyelitis [2]