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 ...

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 "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 pro ...

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].

Business Update Exhibit 99.1 BiomX Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business and Program Updates Ness Ziona, Israel, March 25, 2025 -- (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE, the "Company" or "BiomX"), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced financial results for the fourth quarter and full year ended December 31, 2024, and provided program and business updat ...

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]

Proceeds to support advancement of BX004 program through Phase 2b study topline results in cystic fibrosis (CF) patients, anticipated in Q1 2026 Financing will also support analysis of real-world evidence in people with CF to explore the relationship between P. aeruginosa reduction and clinical outcomes NESS ZIONA, Israel, Feb. 26, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE, the “Company” or “BiomX”), a clinical-stage company advancing novel natural and engineered phage therapies that target s ...

NESS ZIONA, Israel, Dec. 16, 2024 (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 it received written notification from the NYSE American LLC (“NYSE American”), dated December 10, 2024, stating that the Company has regained compliance with all NYSE American LLC continued listing standards. Specifically, the Company has resolved prior ...