Group 1 - The conference call is focused on BiomX's first quarter 2025 financial results and updates on business and programs [3] - The quarterly report on Form 10-Q will be filed with the Securities and Exchange Commission, and a press release was made available at 6:30 a.m. Eastern time [3] - A replay of the conference call will be accessible in the Investors section of the company's website [3] Group 2 - The call includes forward-looking statements regarding the company's cash sufficiency, pipeline, clinical trial designs, expected discussions with regulatory agencies, and potential benefits of product candidates [4] - The company emphasizes that past and current clinical trials do not guarantee future results [5]

[Part I. Financial Information](index=5&type=section&id=Part%20I.%20Financial%20Information) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Presents BiomX Inc.'s unaudited condensed consolidated financial statements for Q1 2025, including balance sheets, statements of operations, equity, and cash flows Condensed Consolidated Balance Sheets (unaudited) | (USD in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total current assets** | 23,533 | 20,520 | | **Total assets** | **45,654** | **43,233** | | **Total current liabilities** | 7,021 | 8,267 | | **Total liabilities** | 21,155 | 19,085 | | **Total stockholders' equity** | **24,499** | **24,148** | Condensed Consolidated Statements of Operations (unaudited) | (USD in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development ("R&D") expenses, net | 5,250 | 4,105 | | General and administrative expenses | 2,506 | 2,680 | | **Operating loss** | **7,756** | **6,785** | | Loss (income) from change in fair value of warrants | (914) | 8,010 | | **Net loss** | **7,659** | **17,327** | | **Basic and diluted loss per share** | **0.33** | **2.78** | Condensed Consolidated Statements of Cash Flows (unaudited) | (USD in thousands) | For the Three Months Ended March 31, 2025 | For the Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | (8,712) | (11,356) | | Net cash provided by investing activities | 51 | 663 | | Net cash provided by financing activities | 11,913 | 38,975 | | **Increase in cash and cash equivalents** | **3,252** | **28,282** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2025 financial condition and operations, covering business, clinical developments, results, liquidity, and going concern [Business Overview](index=32&type=section&id=MD%26A%20-%20Business%20Overview) BiomX develops phage therapies for chronic diseases like CF and DFO, utilizing fixed cocktail and personalized approaches, and acquired APT in March 2024 - The company develops phage therapies to kill specific harmful bacteria associated with chronic diseases like cystic fibrosis (CF) and diabetic foot osteomyelitis (DFO)[133](index=133&type=chunk) - BiomX employs two main product types: fixed cocktail therapy using its proprietary BOLT platform and personalized therapy matching optimal phage to specific patients[134](index=134&type=chunk)[136](index=136&type=chunk) - On **March 15, 2024**, BiomX acquired Adaptive Phage Therapeutics (APT), a stock-for-stock transaction that made APT a wholly-owned subsidiary and added two Phase 2 assets to BiomX's pipeline[137](index=137&type=chunk)[51](index=51&type=chunk) [Clinical and Pre-Clinical Developments](index=33&type=section&id=MD%26A%20-%20Clinical%20and%20Pre-Clinical%20Developments) BiomX advances BX004 (CF) to Phase 2b, plans BX211 (DFO) Phase 2/3 after positive Phase 2 results, and discontinued BX005 (Atopic Dermatitis) - **BX004 (Cystic Fibrosis):** A Phase 2b study is expected to start in **Q2 2025**. Results are now anticipated in **Q1 2026** due to manufacturing delays. The FDA has granted this program Fast Track and orphan drug designations[143](index=143&type=chunk)[144](index=144&type=chunk) - **BX211 (Diabetic Foot Osteomyelitis):** Positive Phase 2 trial results announced in **March 2025** showed the treatment was safe and produced a sustained and statistically significant percent area reduction (PAR) of the ulcer. A Phase 2/3 trial is being planned, pending FDA feedback and funding[148](index=148&type=chunk)[150](index=150&type=chunk)[153](index=153&type=chunk) - **Discontinued Program:** The development of BX005 for Atopic Dermatitis was discontinued in **2024** to focus resources on the more advanced CF and DFO programs[156](index=156&type=chunk) [Results of Operations](index=36&type=section&id=MD%26A%20-%20Results%20of%20Operations) Q1 2025 net loss significantly improved to $7.7 million due to warrant fair value changes and reduced interest expense, despite increased R&D Comparison of Consolidated Results of Operations (unaudited) | (USD in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | R&D expenses, net | 5,250 | 4,105 | | General and administrative expenses | 2,506 | 2,680 | | **Operating loss** | **7,756** | **6,785** | | **Net loss** | **7,659** | **17,327** | | **Basic and diluted loss per share** | **$0.33** | **$2.78** | - R&D expenses increased by **$1.1 million (27%)** YoY, driven by preparations for the Phase 2b trial of BX004 (CF) and increased expenses for the DFO trial[158](index=158&type=chunk)[165](index=165&type=chunk) - Interest expenses fell **99%** to just **$5,000** from **$850,000** in Q1 2024, following the full repayment of the Hercules loan in **March 2024**[161](index=161&type=chunk) - A significant swing from an **$8.0 million loss** to a **$0.9 million income** from the change in fair value of warrants was a primary driver of the reduced net loss in **Q1 2025**[162](index=162&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=MD%26A%20-%20Liquidity%20and%20Capital%20Resources) BiomX holds $21.2 million cash, sufficient until Q1 2026, but faces going concern doubts, with Q1 2025 financing raising $11.9 million - The company's cash, cash equivalents, and restricted cash of **$21.2 million** as of **March 31, 2025**, are projected to be sufficient to fund operations into the **first quarter of 2026**[181](index=181&type=chunk) - Management has concluded there is substantial doubt about the Company's ability to continue as a going concern, citing the need for additional funds to support operating expenses[166](index=166&type=chunk)[50](index=50&type=chunk) - In **Q1 2025**, net cash provided by financing activities was **$11.9 million**, mainly from the **February 2025 SPA** and related warrant exercises, which raised gross proceeds of **$5.5 million** and **$6.5 million**, respectively[173](index=173&type=chunk)[178](index=178&type=chunk)[179](index=179&type=chunk) - In **Q1 2024**, net cash from financing was **$39.0 million**, driven by a **$50 million PIPE** financing, partially offset by a **$10.7 million** repayment of long-term debt[174](index=174&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) BiomX is exempt from market risk disclosures as a smaller reporting company - The company is exempt from this disclosure requirement because it qualifies as a smaller reporting company[183](index=183&type=chunk) [Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) Management confirmed effective disclosure controls and no material changes to internal controls as of March 31, 2025 - Based on an evaluation as of the end of the reporting period, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective[185](index=185&type=chunk) - There were no changes in the company's internal control over financial reporting during the quarter ended **March 31, 2025**, that have materially affected, or are reasonably likely to materially affect, these controls[186](index=186&type=chunk) [Part II. Other Information](index=43&type=section&id=Part%20II.%20Other%20Information) [Exhibits](index=43&type=section&id=Item%206.%20Exhibits.) Lists exhibits filed with the Form 10-Q, including corporate governance documents, officer certifications, and XBRL data - The report includes a list of filed exhibits, such as corporate governance documents (Certificate of Incorporation, Bylaws), CEO/CFO certifications pursuant to SEC rules, and Inline XBRL documents[188](index=188&type=chunk) [Signatures](index=44&type=section&id=Part%20III.%20Signatures) [Signatures](index=44&type=section&id=Signatures) The report concludes with formal signatures by the CEO and CFO on May 15, 2025 - The report was duly signed and authorized on **May 15, 2025**, by Jonathan Solomon (Chief Executive Officer) and Marina Wolfson (Chief Financial Officer)[192](index=192&type=chunk)[194](index=194&type=chunk)

Financial Data and Key Metrics Changes - As of March 31, 2025, the cash balance and restricted cash were $21.2 million, an increase from $18 million as of December 31, 2024, primarily due to funds raised in February 2025 financings [14] - Research and development expenses for Q1 2025 were $5.3 million, up from $4.1 million in Q1 2024, attributed to preparations for clinical trials and increased expenses related to the DFO product candidate [15] - The net loss for Q1 2025 was $7.7 million, a decrease from $17.3 million in Q1 2024, mainly due to changes in the fair value of warrants issued [17] Business Line Data and Key Metrics Changes - The company reported positive top-line results from the Phase 2 trial of BX211 for diabetic foot osteomyelitis, indicating a significant unmet patient need [5][9] - The Phase 2 trial of BX211 showed a statistically significant reduction in ulcer size, with a difference greater than 40% from placebo by week ten [10] Market Data and Key Metrics Changes - Approximately 160,000 lower limb amputations occur annually in diabetic patients in the U.S., with 85% estimated to be caused by diabetic foot infections [6][7] - The total financial burden on the U.S. healthcare system due to diabetic amputations is approximately $8 billion annually [7] Company Strategy and Development Direction - The company plans to discuss potential Phase 2/3 trials for BX211 with regulatory agencies later this year, aiming for breakthrough and orphan designations [22] - The company is exploring funding and partnering opportunities to advance BX211's clinical development [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the pipeline and the ability to advance therapeutics addressing high unmet needs [13] - The company anticipates a top-line readout of the Phase 2b study of BX004 in cystic fibrosis in the first quarter of 2026, which remains on track [6][33] Other Important Information - The U.S. Defense Health Agency has contributed approximately $40 million in non-dilutive funding for the development of BX211 [12] - The company held a KOL event that received positive feedback from industry experts regarding the strength of the data from the Phase 2 trial [11] Q&A Session Summary Question: Regulatory interactions and plans for DFO program - Management is gearing up for discussions with regulatory agencies later this year, considering options for breakthrough and orphan designations [22] Question: Expansion of physician interest in DFO program - There has been significant interest from various centers in the U.S. and Europe regarding participation in the next steps of the DFO program [25] Question: Timeline for CF Phase 2 trial - The CF Phase 2 trial is on track, with no impediments expected, and centers are eager to enroll patients [33] Question: Potential for moving directly to Phase 3 for BX211 - There is a chance to pursue a pivotal study for BX211, pending confirmation from regulatory agencies [35] Question: Prospects for publications and medical conferences - The company is working on presenting data at medical conferences and aims to publish findings due to the quality of the data [37] Question: Safety database size for Phase therapy - Historically, around 300 patients are targeted for orphan indications, but the company hopes to reduce this number based on the safety profile of the product [40]

Financial Data and Key Metrics Changes - As of March 31, 2025, the cash balance and restricted cash were $21.2 million, an increase from $18 million as of December 31, 2024, primarily due to funds raised in February 2025 financings [13] - Research and development expenses net were $5.3 million for Q1 2025, compared to $4.1 million for Q1 2024, reflecting preparations for clinical trials and increased expenses related to the DFO product candidate [14] - General and administrative expenses decreased to $2.5 million in Q1 2025 from $2.7 million in Q1 2024, attributed to prior year expenses related to an acquisition [14] - The net loss for Q1 2025 was $7.7 million, a significant decrease from $17.3 million in Q1 2024, mainly due to changes in the fair value of warrants [15] - Net cash used in operating activities was $8.7 million for Q1 2025, down from $11.4 million for the same period in 2024 [16] Business Line Data and Key Metrics Changes - The company reported positive top-line results from the Phase 2 trial of BX211 for diabetic foot osteomyelitis, indicating a significant unmet patient need [5][6] - The Phase 2 trial of BX211 showed a statistically significant reduction in ulcer size, with a difference greater than 40% from placebo by week ten [9] Market Data and Key Metrics Changes - The U.S. healthcare system incurs approximately $8 billion annually due to diabetic amputations, with a staggering number of 160,000 lower limb amputations occurring each year among diabetic patients [7] - The five-year mortality rate for patients with diabetic foot infections who undergo amputations is between 30% to 50%, highlighting the critical need for effective treatments [7] Company Strategy and Development Direction - The company plans to advance BX211 through potential Phase 2/3 trials, pending feedback from regulatory agencies, and is exploring funding and partnership opportunities [10] - The company aims to leverage the recent positive data to pursue breakthrough and orphan designations for regulatory interactions [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the clinical pipeline and the ability to advance therapeutics addressing high unmet needs, particularly in cystic fibrosis and diabetic foot osteomyelitis [12] - The company anticipates a top-line readout of the Phase 2b study of BX004 in cystic fibrosis in the first quarter of 2026, which remains on track [12][33] Other Important Information - The U.S. Defense Health Agency has contributed approximately $40 million in non-dilutive funding to support the development of BX211 [11] - The company successfully completed a $12 million financing, which is expected to ensure continued development of its pipeline [5][12] Q&A Session Summary Question: Regulatory interactions regarding the DFO program - Management indicated ongoing discussions with regulatory agencies and plans to discuss potential breakthrough and orphan designations later this year [21][22] Question: Expansion of physician interest in the DFO program - There has been significant interest from various centers in the U.S. and Europe, with plans for a global study [25][26] Question: Timeline for the CF Phase 2 trial - The trial is on track, with no impediments anticipated, and patient recruitment is expected to proceed smoothly [32][33] Question: Potential for a pivotal study for BX211 - Management is considering the possibility of moving directly to a pivotal study based on the positive data, pending discussions with regulatory agencies [37][38] Question: Publication and conference prospects for BX211 data - The company is working on presenting data at medical conferences and aims to publish findings due to the quality of the data [39][40] Question: Safety database size for regulatory approval - Management indicated that they hope to reduce the number of patients needed for the safety database based on the product's safety profile [42][43]

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]

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]