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]

Core Insights - BiomX Inc. has entered into a securities purchase agreement for a registered direct offering and private placement, expecting gross proceeds of approximately $12 million to support the BX004 program and real-world evidence analysis in cystic fibrosis patients [1][2][3] Financing Details - The offerings include the purchase of 3,633,514 shares of common stock at an effective price of $0.9306 per share and a concurrent private placement for 2,305,871 unregistered pre-funded warrants at the same price [3][5] - The offerings were led by Deerfield Management Company with participation from the Cystic Fibrosis Foundation and other investors, expected to close around February 27, 2025 [1][2] Clinical Development - BiomX is advancing BX004, a fixed phage cocktail for treating cystic fibrosis patients with chronic pulmonary infections caused by Pseudomonas aeruginosa, with topline results from the Phase 2b study anticipated in Q1 2026 [1][9] - The Phase 2b trial will enroll approximately 60 patients and is designed to monitor safety, tolerability, and clinical outcomes [9] Regulatory Status - BX004 has received Fast Track designation and Orphan Drug Designation from the FDA, with plans to present real-world evidence analysis to the FDA and European Committee for Medicinal Products for Human Use later this year [2][9] Additional Product Development - BiomX is also developing BX211, a personalized phage treatment for diabetic foot osteomyelitis, with topline results expected in Q1 2025 and Q1 2026 for different study readouts [10][11] Company Overview - BiomX is focused on developing natural and engineered phage therapies targeting harmful bacteria for chronic diseases, utilizing its BOLT platform to customize phage compositions [12]

Group 1 - BiomX Inc. has regained compliance with all NYSE American continued listing standards as of December 10, 2024, resolving prior deficiencies noted on May 23, 2024 [1] - The company has demonstrated compliance for a period of two consecutive quarters as required by the NYSE American Company Guide [1] Group 2 - BiomX is a clinical-stage company focused on developing natural and engineered phage therapies targeting specific pathogenic bacteria for chronic diseases [2] - The company utilizes its BOLT platform to customize phage compositions against proprietary bacterial targets [2]

Acquisition and Stock Transactions - The acquisition of Adaptive Phage Therapeutics LLC (APT) was completed on March 15, 2024, with BiomX issuing 9,164,968 shares of common stock and 40,470 shares of Series X Preferred Stock as part of the stock-for-stock transaction [140]. - BiomX's stockholders prior to the acquisition owned approximately 55% of the share capital, while APT's stockholders owned approximately 45% [142]. - On March 15, 2024, the company raised approximately $50 million through a PIPE transaction, involving the issuance of 216,417 Redeemable Convertible Preferred Shares and Private Placement Warrants [193]. Research and Development - The Phase 1b/2a trial for BX004 in cystic fibrosis patients showed a reduction of -1.42 log in Pseudomonas aeruginosa colony-forming units compared to -0.28 log in the placebo group at Day 15 [148]. - 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 [153]. - BX004 received Fast Track designation from the FDA in August 2023 and orphan drug designation in December 2023 [155]. - BiomX plans to initiate a Phase 2b study for BX004 in cystic fibrosis patients in Q4 2024, enrolling approximately 60 patients and monitoring safety and microbiological reduction [156]. - The ongoing Phase 2 trial for BX211 in diabetic foot osteomyelitis has completed enrollment, with topline results expected at week 13 and further evaluations at week 52 [158]. - Development of BX005 for atopic dermatitis was discontinued in 2024 to focus resources on cystic fibrosis and diabetic foot osteomyelitis programs [162]. - The company has paused development of its personalized phage therapy for prosthetic joint infections to prioritize cystic fibrosis and diabetic foot osteomyelitis programs [160]. - The company plans to continue focusing on the development of product candidates BX004 and BX211, while exploring additional funding options to support operations [182]. Financial Performance - R&D expenses for Q3 2024 were $7.3 million, a 30% increase from $5.6 million in Q3 2023, primarily due to clinical trial preparations and increased rent expenses following the APT Acquisition [165]. - General and administrative expenses rose to $3.2 million in Q3 2024, up 45% from $2.2 million in Q3 2023, mainly due to the consolidation of expenses after the Acquisition [167]. - Goodwill impairment of $0.8 million was recorded in Q3 2024, resulting from the Acquisition and a decline in market capitalization [168]. - Operating loss for Q3 2024 was $11.3 million, compared to $7.8 million in Q3 2023, reflecting increased expenses [165]. - Net loss for Q3 2024 was $9.6 million, compared to a net income of $7.9 million in Q3 2023, with basic and diluted loss per share at $(0.31) compared to $1.30 in the prior year [172]. - For the nine months ended September 30, 2024, R&D expenses totaled $18.3 million, a 31% increase from $14.0 million in the same period in 2023 [174]. - Net cash used in operating activities for the nine months ended September 30, 2024 was $30.7 million, compared to $15.0 million in the same period in 2023 [183]. - The company recorded $2.2 million in other income for the nine months ended September 30, 2024, a 633% increase from $0.3 million in the same period in 2023 [177]. - As of September 30, 2024, the company had liquidity resources of approximately $24.7 million, expected to fund operations into Q4 2025 [195]. - The company has accumulated a deficit of $166.2 million since inception and does not expect to generate significant revenues from product sales in the next twelve months [195]. - The company plans to fund future operations and development activities through public or private equity issuances, debt securities, loans, and possibly additional grants [196]. - For the nine months ended September 30, 2024, net cash provided by financing activities was $39.0 million, primarily from the issuance of Redeemable Convertible Preferred Shares and Private Placement Warrants totaling $49.5 million, offset by a long-term debt prepayment of $10.7 million [189]. - During the same period in 2023, net cash provided by financing activities was $4.2 million, mainly from the issuance of Common Stock of $7.2 million, offset by long-term debt repayment of $2.9 million [190]. - The company prepaid $10.4 million of the Hercules Loan on March 19, 2024, which included an end-of-term charge of $983,000 and accrued interest of $69,000 [191]. - As of September 30, 2024, all Pre-Funded Warrants have been exercised, resulting in the issuance of 1,458,638 shares of Common Stock [194]. Market and Operational Risks - The company has not experienced disruptions to its business operations due to the ongoing conflict in Israel, but the situation remains unpredictable [206]. - Political instability in Israel may adversely affect the company's operations and financial condition [209].

Financial Data and Key Metrics Changes - Cash balance, short-term deposits, and restricted cash as of September 30, 2024, were $24.7 million, down from $30.7 million as of December 31, 2023, primarily due to net cash used in operating activities and repayment of Hercules debt facility, partially offset by a $50 million private placement financing in March 2024 [22] - Net income for Q3 2024 was $9.6 million, compared to a net loss of $7.9 million for the same period in 2023, primarily reflecting non-cash income from the revaluation of warrants issued during the March 2024 financing [25] - Research and development expenses increased to $7.3 million in Q3 2024 from $5.6 million in Q3 2023, driven by preparations for the Phase 2b trial of BX004 and increased expenses related to the clinical trial of BX211 [23] - General and administrative expenses rose to $3.2 million in Q3 2024 from $2.2 million in Q3 2023, attributed to the consolidation of expenses following the acquisition of Adaptive Phage Therapeutics [24] Business Line Data and Key Metrics Changes - The company completed patient enrollment for the BX211 Phase 2 trial of diabetic foot osteomyelitis (DFO), with top-line results expected in Q1 2025 [8] - Manufacturing delays for BX004 were experienced, but the issues have been resolved, and top-line results for the Phase 2b study are now expected in the first half of 2026 [16] Market Data and Key Metrics Changes - The company highlighted the significant unmet need in treating DFO, with approximately 160,000 lower limb amputations in diabetic patients in the U.S. annually, 85% of which are estimated to be caused by DFO [9] Company Strategy and Development Direction - The company is focused on advancing its clinical pipeline, particularly the BX211 program for DFO, and believes that phage-based therapies can address challenges faced by traditional antibiotics [7][11] - The company aims to leverage its phage therapy pipeline to address serious chronic infections and improve treatment outcomes for patients [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the promising data reported and looks forward to significant milestones in the upcoming quarters, particularly for the BX211 Phase 2 trial [20] - The company views the manufacturing delays for BX004 as potentially one-off challenges related to scaling up production [30] Other Important Information - A 1 to 10 reverse stock split was implemented in August 2024, consolidating outstanding shares without affecting the par value or authorized number of shares [26] Q&A Session Summary Question: Details on manufacturing delay for BX004 - Management indicated that the manufacturing delay was viewed as potentially one-off, related to scaling up production volumes from 10 liters to 50 liters, and expressed confidence in the revised timeline [30]

| --- | --- | --- | --- | --- | --- | |-----------------------------------------------------------------------------------------------------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Revolutionizing the Treatment of Infections Associated with Chronic Disease Through Phage Therapy | | | | | | | INVESTOR PRESENTATION | | | | | | | November 2024 | | | | | | | NYSE American: PHGE | | | | | | 1 SAFE HARBOR STATEMENT About this Presentation Th ...

Clinical Trials - Patient enrollment for the BX211 Phase 2 trial in Diabetic Foot Osteomyelitis (DFO) has been completed, with topline results expected in Q1 2025[2] - In the BX004 Phase 1b/2a trial, 14.3% of patients converted to sputum culture negative for Pseudomonas aeruginosa after 10 days of treatment, compared to 0% in the placebo arm[6] - The company expects to report topline results for the BX004 Phase 2b study in the first half of 2026 following resolved manufacturing delays[2] Financial Performance - BiomX reported a net income of $9.6 million for Q3 2024, compared to a net loss of $7.9 million in Q3 2023, primarily due to changes in the fair value of warrants[14] - Operating loss for the nine months ended September 30, 2024, was $27,838 million, compared to $20,076 million for the same period in 2023, indicating a 38.5% increase in losses[26] - Net loss for the three months ended September 30, 2024, was $9,642 million, compared to a net income of $7,906 million in the same period last year, marking a significant shift in performance[26] - Basic loss per share for the three months ended September 30, 2024, was $(0.31), compared to earnings of $1.30 per share in the same period last year[26] Expenses - Research and development expenses increased to $7.3 million in Q3 2024 from $5.6 million in Q3 2023, driven by preparations for the Phase 2b clinical trial of BX004 and increased expenses related to BX211[11] - General and administrative expenses rose to $3.2 million in Q3 2024 from $2.2 million in Q3 2023, attributed to the consolidation of expenses after the acquisition of Adaptive Phage Therapeutics[12] - Research and development (R&D) expenses for the three months ended September 30, 2024, were $7,279 million, up from $5,641 million in the same period last year, reflecting a 29% increase[26] Cash and Assets - Cash balance as of September 30, 2024, was $24.7 million, down from $30.7 million as of December 31, 2023, due to net cash used in operating activities[9] - BiomX estimates its cash and equivalents are sufficient to fund operations into the fourth quarter of 2025[9] - Total current assets increased to $28,316 million as of September 30, 2024, compared to $17,632 million as of December 31, 2023, representing a growth of 60.5%[24] - Total non-current assets rose to $31,664 million as of September 30, 2024, from $7,397 million as of December 31, 2023, an increase of 327%[24] - Total current liabilities decreased to $8,944 million as of September 30, 2024, from $11,176 million as of December 31, 2023, a reduction of 19.8%[25] Stock and Shareholder Information - The company conducted a 1-for-10 reverse stock split in August 2024, consolidating every ten shares into one[7] - The weighted average number of shares used in computing basic loss per share increased to 16,366,122 for the three months ended September 30, 2024, from 6,058,774 in the same period last year[26] Liabilities - The company reported a significant increase in operating lease liabilities, which rose to $8,651 million as of September 30, 2024, compared to $3,239 million as of December 31, 2023[25] - The company recorded a loss from the change in fair value of Private Placement Warrants amounting to $(20,559) million for the three months ended September 30, 2024[26]