Core Viewpoint - BiomX Inc. is currently under FDA evaluation for its nebulizer device used in the Phase 2b trial of BX004 for cystic fibrosis, with a clinical hold in place due to data review concerns regarding the device [1][2][3]. Group 1: FDA Evaluation and Clinical Hold - The FDA has placed a clinical hold on the Phase 2b study while reviewing data submitted by BiomX regarding the third-party nebulizer used for BX004 delivery [2][4]. - No concerns were raised about the BX004 drug candidate itself in the clinical hold notification, and patient enrollment and dosing outside the U.S. continue as per protocol [3][4]. Group 2: Company Actions and Future Expectations - BiomX is collaborating with the nebulizer manufacturer to address the FDA's follow-up information requests, which are considered readily addressable [4]. - The company anticipates that U.S. enrollment will resume once the FDA's concerns are resolved, and topline results are now expected in the second quarter of 2026 following protocol updates [5][6]. Group 3: Financial Position and Stock Performance - As of September 30, 2025, BiomX reported a cash balance of $8.1 million, which is projected to fund operations into the first quarter of 2026 [7]. - BiomX shares experienced a decline of 7.18%, trading at $5.36, close to its 52-week low of $4.65 [7].

Core Viewpoint - BiomX Inc. is addressing FDA follow-up information requests to lift the clinical hold on its Phase 2b trial for BX004, a treatment targeting Pseudomonas aeruginosa in cystic fibrosis patients, with topline results now expected in Q2 2026 [1][4][5] Company Updates - The FDA is continuing its evaluation of the nebulizer device used for BX004 administration, and BiomX is collaborating with the third-party manufacturer to provide the necessary information [1][2] - An independent Data Monitoring Committee (DMC) has completed a safety review of the BX004 Phase 2b trial and recommended that the study continue with an adjusted dosing regimen [3][4] - The trial protocol will be updated accordingly, and pending financial resources, the company expects to enroll approximately 60 patients in the Phase 2b trial [5] Product Information - BX004 is a fixed multi-phage cocktail designed to target Pseudomonas aeruginosa, which significantly impacts morbidity and mortality in cystic fibrosis patients [5] - Positive results from earlier phases of the trial indicated safety, tolerability, and improvement in pulmonary function associated with reduced bacterial load [5] Future Expectations - The company remains optimistic about the path forward for BX004 and looks forward to reporting topline results in the second quarter of 2026 [4][5]

Core Insights - BiomX Inc. is addressing FDA follow-up information requests to lift the clinical hold on the nebulizer device used in the Phase 2b trial of BX004 for cystic fibrosis patients [1][2][4] - An independent Data Monitoring Committee (DMC) has reviewed the safety of the BX004 Phase 2b trial and recommended that the study continue with an adjusted dosing regimen, with topline results now expected in Q2 2026 [3][4] Company Updates - The company is collaborating with a third-party manufacturer to provide the FDA with the necessary information to resolve outstanding questions regarding the nebulizer device [2][4] - BiomX has previously reported positive results from Part 1 and Part 2 of the Phase 1b/2a trials, demonstrating safety, tolerability, and improvement in pulmonary function in a specific patient subgroup [5] Product Information - BX004 is a multi-phage cocktail targeting Pseudomonas aeruginosa, a significant cause of morbidity in cystic fibrosis patients [5] - The company plans to enroll approximately 60 patients in a randomized, double-blind, placebo-controlled Phase 2b trial, pending the resolution of the FDA clinical hold [5]

Core Viewpoint - BiomX Inc. is preparing for a reverse stock split to enhance its stock price and marketability, consolidating every 19 shares into 1 new share, effective November 25, 2025 [1][2]. Company Overview - BiomX Inc. is a clinical-stage company focused on developing phage therapies that target specific pathogenic bacteria [1]. - The company's current stock price is $0.29, reflecting an 8.31% decrease from the previous trading session [2]. Stock Performance - Over the past year, BiomX's stock has experienced significant volatility, with a high of $1.161 and a low of $0.29 [3]. - The company's market capitalization is approximately $7.7 million, indicating its current valuation in the market [3]. - The trading volume on the AMEX exchange is 310,088 shares, suggesting active investor interest [3]. Reverse Stock Split Details - The Board of Directors approved the one-for-nineteen reverse stock split ratio on November 13, 2025 [2]. - Following the reverse stock split, the stock will continue to trade under the symbol "PHGE" on the NYSE American, with a new CUSIP number of 09090D 509 [2].

Core Points - BiomX Inc. announced a one-for-nineteen reverse stock split of its common stock, effective November 25, 2025 [1][2][3] - The reverse stock split was approved by stockholders at the 2025 Annual Meeting on October 16, 2025, with the final ratio set by the Board of Directors on November 13, 2025 [2] - Following the reverse stock split, the number of outstanding shares will decrease from approximately 29,006,165 to about 1,526,640 [4] Company Overview - BiomX is a clinical-stage company focused on developing natural and engineered phage therapies to target specific pathogenic bacteria [5] - The company utilizes its BOLT platform to customize phage compositions aimed at treating chronic diseases with significant unmet medical needs [5]

Core Viewpoint - BiomX Inc. announced a one-for-nineteen reverse stock split of its common stock, effective November 25, 2025, to enhance its stock price and maintain compliance with NYSE American listing requirements [1][2][3]. Group 1: Reverse Stock Split Details - The reverse stock split will convert nineteen current shares into one new share, affecting all stockholders uniformly without altering their percentage ownership interest [3][4]. - The number of outstanding shares will decrease from approximately 29,006,165 to about 1,526,640, with adjustments for fractional shares [4]. - No fractional shares will be issued; stockholders entitled to fractional shares will receive an additional fraction to round up to the next whole share [4]. Group 2: Company Background - BiomX is a clinical-stage company focused on developing natural and engineered phage therapies targeting harmful bacteria for chronic diseases with significant unmet needs [5]. - The company utilizes its BOLT platform to customize phage compositions against proprietary bacterial targets [5].

Acquisition and Partnerships - BiomX completed the acquisition of Adaptive Phage Therapeutics (APT) on March 15, 2024, exchanging 916,497 shares of common stock and 40,470 shares of Series X Preferred Stock[128]. - BiomX is supporting an NIH study targeting Pseudomonas aeruginosa infections in CF patients under FDA emergency Investigational New Drug allowance[145]. Product Development and Trials - BX004, a therapeutic phage product candidate for chronic pulmonary infections caused by Pseudomonas aeruginosa, showed a 2.7 log₁₀ CFU/g treatment effect compared to placebo in a Phase 1b/2a trial[133]. - In Part 2 of the Phase 1b/2a trial for BX004, 23 CF patients received treatment, with no safety events related to the drug reported[134]. - The FDA granted BX004 Fast Track designation for treating chronic respiratory infections in CF patients in August 2023[135]. - BiomX initiated a Phase 2b study for BX004 in CF patients, with the first patient dosed on July 14, 2025, aiming to enroll up to 60 patients[136]. - The FDA placed a clinical hold on the Phase 2b study in October 2025, focusing on the third-party nebulizer device used for BX004 delivery[137]. - BX211 demonstrated a statistically significant percent area reduction (PAR) of ulcer size in a DFO trial, with p = 0.046 at week 12[146]. - BX211 was found safe and well-tolerated, with significant improvements in ulcer depth and area compared to placebo[146]. - BX011 is prioritized for development in diabetic foot infections (DFI) before expanding to diabetic foot osteomyelitis (DFO), pending financial resources[143]. Financial Performance - R&D expenses for Q3 2025 were $6.1 million, a decrease of 16% from $7.3 million in Q3 2024[151]. - General and administrative expenses for Q3 2025 were $2.4 million, down 25% from $3.2 million in Q3 2024[152]. - The net loss for Q3 2025 was $9.2 million, compared to a net income of $9.6 million in Q3 2024[150]. - Basic and diluted loss per share for Q3 2025 was $0.29, compared to earnings of $0.31 per share in Q3 2024[157]. - For the nine months ended September 30, 2025, R&D expenses were $16.4 million, a decrease of 10% from $18.3 million in the same period in 2024[159]. - General and administrative expenses for the nine months ended September 30, 2025 were $7.3 million, down 17% from $8.8 million in the same period in 2024[160]. - The net loss for the nine months ended September 30, 2025 was $22.9 million, compared to a net loss of $3.2 million in the same period in 2024[159]. - Net cash used in operating activities for the nine months ended September 30, 2025 was $22.0 million, a decrease from $30.7 million in the same period in 2024[169]. - The company recorded a loss from the change in fair value of warrants of $1.7 million for the nine months ended September 30, 2025, compared to a loss of $24.4 million in the same period in 2024[164]. - The company believes its cash and cash equivalents will be sufficient to meet working capital needs into Q1 2026, but requires additional funds for operating expenses and capital requirements[168]. - Net cash used in operating activities for the nine months ended September 30, 2024 was $30.7 million, primarily driven by R&D and general administrative expenses[171]. - Net cash provided by investing activities during the nine months ended September 30, 2024 was $0.7 million, mainly from cash and restricted cash acquired from the Acquisition[172]. - Net cash provided by financing activities during the nine months ended September 30, 2024 was $39.0 million, primarily from the issuance of Redeemable Convertible Preferred Shares and Private Placement Warrants[176]. - As of September 30, 2025, liquidity resources consisted of approximately $8.1 million in cash, cash equivalents, and restricted cash, expected to fund operations into Q1 2026[183]. - The company has accumulated a deficit of $203.6 million since inception and does not expect to generate significant revenues from product sales in the next twelve months[183]. - The company plans to fund operations and development activities through future public or private equity issuances, debt securities, and possibly additional grants[184]. - As of September 30, 2024, the company had outstanding foreign exchange contracts for the exchange of USD to NIS amounting to approximately $3.4 million[174]. - The company raised approximately $50 million from a private investment in public equity (PIPE) in March 2024, resulting in the issuance of Redeemable Convertible Preferred Shares and warrants[180]. - The gross proceeds from the February 2025 Securities Purchase Agreement were $5.5 million, before deducting fees and expenses[181]. - The company expects to continue incurring additional losses in the foreseeable future due to ongoing R&D activities[184].

Financial Data and Key Metrics Changes - The cash balance and restricted cash as of September 30, 2025, were $8.1 million, down from $18 million as of December 31, 2024, primarily due to net cash used in operating activities [11] - Research and development expenses net were $6.1 million for Q3 2025, compared to $7.3 million for Q3 2024, driven by reduced salary expenses and lower rent expenses [12] - General and administrative expenses were $2.4 million for Q3 2025, down from $3.2 million for Q3 2024, mainly due to reduced salary and share-based compensation expenses [13] - The net loss for Q3 2025 was $9.2 million, compared to a net income of $9.6 million for Q3 2024, primarily due to changes in the fair value of warrants [13] Business Line Data and Key Metrics Changes - The BX004 program for cystic fibrosis patients made significant progress despite regulatory challenges, with first patient dosing in the phase IIB trial [5] - The BX011 program targeting Staphylococcus aureus infections in diabetic foot infections received positive FDA feedback, supporting its development as an off-the-shelf formulation [8][9] Market Data and Key Metrics Changes - Approximately 160,000 lower limb amputations occur annually in diabetic patients in the U.S., with 85% stemming from diabetic foot infections or osteomyelitis, highlighting a significant unmet medical need [9] Company Strategy and Development Direction - The company is focused on advancing both BX004 and BX011 through key upcoming milestones, with a clear phase III development pathway for BX004 and a strong regulatory opportunity for BX011 [14] - The strategy includes leveraging existing clinical data and addressing critical unmet medical needs in the diabetic foot infection market [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about resuming enrollment in the BX004 trial following FDA feedback, viewing the clinical hold as a technical challenge rather than a fundamental concern [6][7] - The company sees strong momentum in the phage therapy field and increasing validation of phage-based approaches, which strengthens confidence in upcoming trial readouts [10] Other Important Information - The FDA provided constructive guidance for BX011, outlining a clear potential pathway toward a biologics license application without the need for additional non-clinical studies [9] Q&A Session Summary Question: Clarification on the defense potential for BX011 - Management indicated that the U.S. Defense Health Agency supports the approval of BX011 through a commercial indication first, with potential expansion later [17][19] Question: Outstanding questions regarding DFI design or inclusion criteria - Management confirmed that there are some fine-tuning aspects but generally good clarity on the clinical study design and endpoints [21][22] Question: Speculation on the FDA's initial clinical hold for BX004 - Management speculated that the hold was due to new requirements for the nebulizer device, viewing it as a technical issue rather than a concern about the drug itself [34] Question: General ideas on the size and duration of the potential phase III study for BX004 - Management indicated that while specifics are still being defined, there is a clear understanding of the phase III study's direction, pending positive data from the phase IIB trial [36]

Financial Performance - Net loss for Q3 2025 was $9.2 million, compared to a net income of $9.6 million in Q3 2024, primarily due to changes in the fair value of warrants[10] - The operating loss narrowed to $8,536 million in Q3 2025 from $11,328 million in Q3 2024, a reduction of approximately 24.7%[22] - Net loss increased to $9,166 million in Q3 2025, compared to a net income of $9,642 million in Q3 2024[22] - Basic loss per share was $0.29 in Q3 2025, compared to a loss of $0.31 per share in Q3 2024[22] - Loss before tax was $9,163 million in Q3 2025, compared to a loss of $9,642 million in Q3 2024[22] - The company reported a loss from change in fair value of warrants of $730 million in Q3 2025, compared to a gain of $20,559 million in Q3 2024[22] Cash Position - Cash balance as of September 30, 2025, was $8.1 million, down from $18 million as of December 31, 2024, primarily due to net cash used in operating activities[6] - BiomX's cash, cash equivalents, and restricted cash are estimated to be sufficient to fund operations into the first quarter of 2026[6] Research and Development - Research and development expenses for Q3 2025 were $6.1 million, a decrease from $7.3 million in Q3 2024, driven by reduced salary expenses and lower rent expenses[8] - R&D expenses decreased to $6,122 million in Q3 2025 from $7,279 million in Q3 2024, a reduction of approximately 15.9%[22] - BiomX plans to prioritize diabetic foot infections as the lead indication for regulatory development, following positive Phase 2 results from BX211[7] - The FDA has provided positive feedback on BX011, confirming a clear clinical development path for the treatment of diabetic foot infections[3] - BiomX expects to report topline results from the Phase 2b study of BX004 in the first quarter of 2026[7] General and Administrative Expenses - General and administrative expenses for Q3 2025 were $2.4 million, down from $3.2 million in Q3 2024, mainly due to reduced salary and share-based compensation expenses[9] - General and administrative expenses fell to $2,414 million in Q3 2025 compared to $3,248 million in Q3 2024, representing a decrease of about 25.6%[22] Other Financial Metrics - Interest expenses remained stable at $5 million for both Q3 2025 and Q3 2024[22] - Goodwill impairment was recorded at $801 million in Q3 2024, with no impairment in Q3 2025[22] Funding and Collaborations - The company received approximately $40 million in non-dilutive funding from the DHA and Department of Navy for the development of phage therapies[14] - The company is in discussions with the U.S. Defense Health Agency regarding the utilization of phage therapy for S. aureus-driven infections[7]

Core Insights - BiomX received positive FDA feedback confirming a clear clinical development pathway for BX011, a multi-phage cocktail targeting S. aureus in diabetic foot infections, building on prior Phase 2 success [1][3] - The company anticipates imminent FDA feedback regarding the clinical hold on BX004, a fixed phage cocktail for chronic Pseudomonas aeruginosa infections in cystic fibrosis patients [1][3] - BiomX plans to prioritize diabetic foot infections (DFI) for regulatory development, leveraging positive Phase 2 results from BX211 in diabetic foot osteomyelitis [6][14] Clinical Program Updates - BX004 is currently under a clinical hold by the FDA while the company reviews data on a third-party nebulizer; however, patient enrollment and dosing outside the U.S. continue [6][8] - The Phase 2b trial for BX004 involves approximately 60 cystic fibrosis patients and aims to measure efficacy endpoints such as bacterial burden reduction and lung function improvement [6][13] - BiomX plans to initiate a Phase 2a trial for BX011 following FDA feedback, with no additional non-clinical studies required [6][14] Financial Results - As of September 30, 2025, BiomX reported a cash balance of $8.1 million, down from $18 million at the end of 2024, primarily due to operating cash usage [8] - Research and development expenses for Q3 2025 were $6.1 million, a decrease from $7.3 million in Q3 2024, attributed to reduced salary and lower rent expenses [9] - The net loss for Q3 2025 was $9.2 million, compared to a net income of $9.6 million in Q3 2024, mainly due to changes in the fair value of warrants [11][21]