BiomX (PHGE) Q1 2025 Earnings Call May 15, 2025 02:00 PM ET Speaker0 Greetings, and welcome to the BioMix First Quarter twenty twenty five Financial Results Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded. I will now turn the conference over to Marina Wolfson, Chief Financial Officer. Thank you. You may begin. Speaker1 Thank you, and welcome to the Bionics conference ca ...

Financial Performance - The net loss for Q1 2025 was $7.7 million, significantly lower than the $17.3 million loss in Q1 2024, attributed to changes in the fair value of warrants[11]. - The net loss for the three months ended March 31, 2025, was $7,659 million, a decrease from a net loss of $17,327 million in the same period of 2024, reflecting an improvement of 55.7%[24]. - Basic and diluted loss per share of Common Stock decreased to $0.33 for the three months ended March 31, 2025, compared to $2.78 for the same period in 2024, showing a significant reduction in loss per share[24]. - The company reported a loss before tax of $7,658 million for the three months ended March 31, 2025, down from $17,322 million in the same period of 2024, reflecting a decrease of 55.7%[24]. - Operating loss for the three months ended March 31, 2025, was $7,756 million, compared to $6,785 million for the same period in 2024, indicating an increase of 14.3%[24]. Research and Development - Research and development expenses for Q1 2025 were $5.3 million, an increase from $4.1 million in Q1 2024, driven by preparations for the Phase 2b trial of BX004 and increased expenses for the BX211 trial[9]. - Research and development expenses for the three months ended March 31, 2025, were $5,250 million, up from $4,105 million in the same period of 2024, indicating an increase of 27.8%[24]. - BiomX announced positive topline results from the Phase 2 trial of BX211, showing a statistically significant reduction in ulcer size with a p-value of 0.046 at week 12[6]. - BX211 demonstrated a greater than 40% reduction in ulcer size compared to placebo by week 10, with significant improvements in ulcer depth and area expansion[14]. - The company is planning a Phase 2/3 clinical trial for BX211 pending feedback from the FDA[6]. - The company anticipates the Phase 2b readout of BX004 for cystic fibrosis in Q1 2026, supported by recent financing activities[7]. Financial Position - BiomX reported a cash balance of $21.2 million as of March 31, 2025, up from $18.0 million at the end of 2024, primarily due to financing activities[8]. - BiomX's cash resources are estimated to be sufficient to fund operations into Q1 2026[8]. - As of March 31, 2025, total current assets increased to $23,533 million from $20,520 million as of December 31, 2024, representing a growth of 14.6%[20]. - Total stockholders' equity increased to $24,499 million as of March 31, 2025, from $24,148 million as of December 31, 2024, marking a rise of 1.5%[20]. - Total current liabilities decreased to $7,021 million as of March 31, 2025, from $8,267 million as of December 31, 2024, a reduction of 15.1%[20]. - Non-current liabilities rose to $14,134 million as of March 31, 2025, from $10,818 million as of December 31, 2024, an increase of 30.5%[20]. Shareholder Information - The weighted average number of shares used in computing basic and diluted loss per share increased significantly to 23,103,105 for the three months ended March 31, 2025, compared to 6,229,228 for the same period in 2024[24].

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]

BiomX (PHGE) Q4 2024 Earnings Call April 01, 2025 12:22 PM ET Company Participants Marina Wolfson - CFO & SecretaryJonathan Eitan Solomon - CEO and Board MemberJoe Pantginis - Managing Director Conference Call Participants Yale Jen - Senior Managing Director & Senior Biotech Analyst Operator Greetings, and welcome to today's BioMx Investor Presentation. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference ...

NESS ZIONA, Israel, April 01, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE:PHGE) ("BiomX" or the "Company"), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, announced that, as previously disclosed in its annual report on Form 10-K for the fiscal year ended December 31, 2024, which was filed with the Securities and Exchange Commission on March 25, 2025, the audit opinion contained a going concern qualification from the Company's independe ...

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].