Executive Summary [Overall Highlights](index=1&type=section&id=Overall%20Highlights) BiomX reported significant clinical progress for BX211 and BX004 and anticipates multiple value-driving catalysts - Positive Phase 2 results for BX211 demonstrated **over 40% wound size reduction** versus placebo in diabetic foot osteomyelitis patients, with planning underway for a potential registrational study[1](index=1&type=chunk)[3](index=3&type=chunk) - New Phase 1b/2a data for BX004 showed **approximately 500-fold (2.7 log₁₀) bacterial reduction** versus placebo with no detectable emergence of resistance[1](index=1&type=chunk)[3](index=3&type=chunk) - The Phase 2b trial of BX004 in Cystic Fibrosis (CF) has successfully commenced patient dosing, with topline results expected in **Q1 2026**[1](index=1&type=chunk)[3](index=3&type=chunk) - BiomX is positioned for multiple value-driving catalysts over the next 12 months, including FDA feedback on BX004's real-world evidence strategy and planning for a potential registrational BX211 study[3](index=3&type=chunk) Clinical Program Updates [BX211 Program Update](index=1&type=section&id=BX211%20Program%20Update) Positive Phase 2 results for BX211 in diabetic foot infections showed significant improvements in wound healing - BX211 demonstrated a sustained and statistically significant percentage area reduction (PAR) of ulcer size with a difference **greater than 40%** by week 10 (p = 0.046 at week 12)[4](index=4&type=chunk)[12](index=12&type=chunk) - The Phase 2 trial also showed statistically significant improvements in ulcer depth (p=0.048) and in reducing the expansion of ulcer area (p=0.017) compared to placebo[6](index=6&type=chunk)[12](index=12&type=chunk) - Planning for a potential registrational study of BX211 is underway, pending feedback from the U.S. Food and Drug Administration (FDA) and availability of cash resources[6](index=6&type=chunk)[12](index=12&type=chunk) - The Company is in continued discussions with the U.S. Defense Health Agency regarding next steps for the BX211 program[6](index=6&type=chunk) [BX004 Program Update](index=2&type=section&id=BX004%20Program%20Update) Patient dosing has begun in the Phase 2b trial for BX004 in Cystic Fibrosis, with results expected in Q1 2026 - In July 2025, BiomX successfully initiated dosing of patients in its Phase 2b trial of BX004, a randomized, double-blind, placebo-controlled, multicenter study in approximately 60 CF patients[6](index=6&type=chunk) - Topline results from the Phase 2b study are expected in the **first quarter of 2026**[6](index=6&type=chunk) - BiomX expects to receive feedback from the FDA in the **second half of 2025** regarding the potential investigation and use of real-world evidence linking bacterial reduction to clinical outcomes[6](index=6&type=chunk) - New findings from the Phase 1b/2a trial showed BX004 achieved **approximately 500-fold (2.7 log₁₀) greater bacterial reduction** compared with placebo, with no bacterial resistance detected[6](index=6&type=chunk) Second Quarter 2025 Financial Results [Cash Position](index=3&type=section&id=Cash%20Position) Cash and restricted cash decreased to $15.2 million, sufficient to fund operations into Q1 2026 Cash and Restricted Cash | Metric | June 30, 2025 (USD in millions) | December 31, 2024 (USD in millions) | | :--- | :--- | :--- | | Cash and restricted cash | 15.2 | 18.0 | - The decrease in cash was primarily due to net cash used in operating activities[7](index=7&type=chunk) - BiomX estimates its cash, cash equivalents and restricted cash are sufficient to fund its operations into the **first quarter of 2026**[7](index=7&type=chunk) [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Operating expenses decreased year-over-year due to workforce reductions and lower professional fees Operating Expenses (Q2 2025 vs. Q2 2024) | Expense Category | Q2 2025 (USD in thousands) | Q2 2024 (USD in thousands) | Change (YoY) | | :--- | :--- | :--- | :--- | | Research and development | 5,014 | 6,897 | -27.3% | | General and administrative | 2,419 | 2,828 | -14.4% | - The decrease in R&D expenses was primarily driven by reduced salary expenses from workforce reductions, lower rent expenses, and increased grant funding, partially offset by higher expenses from initiating the Phase 2b clinical trial of BX004[8](index=8&type=chunk) - The decrease in G&A expenses was primarily attributed to a reduction in legal and other professional service fees, partially offset by increased share-based compensation expenses[9](index=9&type=chunk) [Net Loss and Cash Flow](index=3&type=section&id=Net%20Loss%20and%20Cash%20Flow) The company reported a net loss of $6.0 million for Q2 2025, with a year-over-year decrease in cash used for operations Net Loss and Operating Cash Flow | Metric | Q2 2025 (USD in thousands) | Q2 2024 (USD in thousands) | 6 Months 2025 (USD in thousands) | 6 Months 2024 (USD in thousands) | | :--- | :--- | :--- | :--- | :--- | | Net loss (income) | 6,037 | (4,471) | 13,696 | 12,856 | | Net cash used in operating activities | N/A | N/A | 14,800 | 22,600 | - The net loss for Q2 2025 was mainly due to the change in the fair value of warrants issued as part of the Company's March 2024 financing[10](index=10&type=chunk) - Net cash used in operating activities for the six months ended June 30, 2025, **decreased to $14.8 million** from $22.6 million for the same period in 2024[10](index=10&type=chunk) Company Information & Forward-Looking Statements [Conference Call and Webcast Details](index=3&type=section&id=Conference%20Call%20and%20Webcast%20Details) BiomX hosted a conference call to discuss its Q2 2025 financial results and provide a corporate update - A conference call and webcast were held on August 13, 2025, at 8 AM ET[11](index=11&type=chunk) - Links for registration and webcast replay were provided[12](index=12&type=chunk) [About BX211 (Program Overview)](index=3&type=section&id=About%20BX211%20(Program%20Overview)) BX211 is a phage treatment targeting S. aureus in diabetic foot osteomyelitis, a leading cause of amputation - BX211 is a phage treatment for DFO associated with S. aureus, a bacterial infection of the bone that often leads to amputation in diabetic patients[12](index=12&type=chunk) - Positive Phase 2 results showed BX211 was safe and well-tolerated, producing statistically significant and sustained reduction of ulcer size (PAR) and improvements in ulcer depth[12](index=12&type=chunk) [About BX004 (Program Overview)](index=4&type=section&id=About%20BX004%20(Program%20Overview)) BX004 is a multi-phage cocktail for treating chronic P. aeruginosa infections in Cystic Fibrosis patients - BX004 is a fixed multi-phage cocktail for the treatment of CF patients with chronic pulmonary infections caused by P. aeruginosa, a major contributor to morbidity and mortality[13](index=13&type=chunk) - Positive results from Phase 1b/2a studies demonstrated safety, tolerability, microbiologic activity, and improvement in pulmonary function associated with a reduction in P. aeruginosa burden in a predefined subgroup[13](index=13&type=chunk) - BX004 has received **FDA Fast Track and Orphan Drug Designations**[13](index=13&type=chunk) [About BiomX (Company Overview)](index=4&type=section&id=About%20BiomX%20(Company%20Overview)) BiomX is a clinical-stage company developing phage treatments to destroy harmful bacteria in chronic diseases - BiomX is a clinical-stage company developing natural and engineered phage cocktails and personalized phage treatments[14](index=14&type=chunk) - The company aims to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs, using its BOLT ("BacteriOphage Lead to Treatment") platform[14](index=14&type=chunk) [Safe Harbor Statement](index=4&type=section&id=Safe%20Harbor%20Statement) This section disclaims forward-looking statements, highlighting inherent risks and uncertainties - The press release contains forward-looking statements subject to inherent uncertainties, risks, and changes in circumstances, including adverse results in clinical development, regulatory decisions, and the sufficiency of cash resources[15](index=15&type=chunk) - Investors should not rely on these statements and are advised to review risks and uncertainties detailed in BiomX's SEC filings, particularly the Annual Report on Form 10-K[15](index=15&type=chunk) Financial Statements [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheets show the company's financial position as of June 30, 2025, compared to December 31, 2024 Condensed Consolidated Balance Sheets (USD in thousands) | ASSETS / LIABILITIES AND STOCKHOLDERS' EQUITY | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Current assets | 16,635 | 20,520 | | Total non-current assets | 21,415 | 22,713 | | **Total Assets** | **38,050** | **43,233** | | **LIABILITIES** | | | | Current liabilities | 6,262 | 8,267 | | Total non-current liabilities | 12,628 | 10,818 | | **Total Liabilities** | **18,890** | **19,085** | | **STOCKHOLDERS' EQUITY** | | | | Total stockholders' equity | 19,160 | 24,148 | | **Total Liabilities and Stockholders' Equity**| **38,050** | **43,233** | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statements of operations detail financial performance for the three and six months ended June 30, 2025 Condensed Consolidated Statements of Operations (USD in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development ("R&D") expenses, net | 5,014 | 6,897 | 10,264 | 11,002 | | General and administrative expenses | 2,419 | 2,828 | 4,925 | 5,508 | | Operating loss | 7,433 | 9,725 | 15,189 | 16,510 | | Net loss (income) | 6,037 | (4,471) | 13,696 | 12,856 | | Basic loss (earnings) per share of Common Stock | 0.19 | (0.14) | 0.50 | 1.95 | | Diluted loss per share of Common Stock | 0.19 | 0.69 | 0.50 | 1.95 |

Core Insights - BiomX Inc. reported positive Phase 2 results for BX211, showing over 40% wound size reduction in diabetic foot osteomyelitis patients compared to placebo, with plans for a potential registrational study [1][3][7] - New data for BX004 published in Nature Communications demonstrated approximately 500-fold bacterial reduction versus placebo, with no emergence of resistance, underscoring the capabilities of BiomX's platform [1][3][7] - The Phase 2b trial of BX004 in cystic fibrosis patients has commenced, with topline results expected in Q1 2026 and FDA feedback on real-world evidence strategy anticipated in H2 2025 [1][3][7] Clinical Program Updates - BX211 is a phage therapy targeting diabetic foot infections associated with Staphylococcus aureus, showing significant improvements in ulcer size and depth [4][13] - BX004 is a fixed phage cocktail for chronic Pseudomonas aeruginosa infections in cystic fibrosis patients, with a Phase 2b trial now underway [5][14] Financial Results - As of June 30, 2025, BiomX reported a cash balance of $15.2 million, down from $18 million at the end of 2024, sufficient to fund operations into Q1 2026 [8] - Research and development expenses for Q2 2025 were $5.0 million, a decrease from $6.9 million in Q2 2024, attributed to reduced salary and rent expenses [9] - General and administrative expenses were $2.4 million for Q2 2025, down from $2.8 million in Q2 2024, mainly due to lower legal fees [10] - The net loss for Q2 2025 was $6.0 million, compared to a profit of $4.5 million in Q2 2024, primarily due to changes in the fair value of warrants [11]

Company Overview - BiomX Inc. is a clinical-stage company focused on developing novel natural and engineered phage therapies targeting specific pathogenic bacteria [4] - The company utilizes its BOLT ("BacteriOphage Lead to Treatment") platform to customize phage compositions against proprietary bacterial targets [4] Upcoming Financial Results - BiomX will report its second quarter 2025 financial results and program updates before the U.S. financial markets open on August 13, 2025 [1] - A conference call and live audio webcast will be held at 8 a.m. ET on the same day to discuss these results [1][2] Conference Call Details - Registration for the conference call is recommended at least 5 minutes prior to the start [2] - The conference call can be accessed via a specific registration link, and a webcast will also be available [3]

Core Insights - The initiation of patient dosing in BiomX's Phase 2b trial for BX004 represents a significant milestone in the development of phage therapy targeting antibiotic-resistant lung infections in cystic fibrosis (CF) patients [1][2] - Topline results from the trial are expected in Q1 2026, with the potential for BX004 to become a leading phage-based therapy for CF patients suffering from chronic Pseudomonas aeruginosa infections [1][2] Company Overview - BiomX Inc. is a clinical-stage company focused on developing natural and engineered phage therapies aimed at specific pathogenic bacteria, particularly for chronic diseases with substantial unmet needs [4] - The company has received FDA Fast Track and Orphan Drug designations for BX004, which is a fixed multi-phage cocktail designed to treat chronic pulmonary infections caused by P. aeruginosa in CF patients [3][4] Clinical Trial Details - The Phase 2b trial is a randomized, double-blind, placebo-controlled study involving approximately 60 CF patients, with a 2:1 randomization to receive either BX004 or placebo via inhalation twice daily for 8 weeks [2][3] - The trial aims to measure multiple efficacy endpoints, including reduction in bacterial burden, improvements in lung function, and enhanced quality of life metrics [2][3] Previous Findings - Prior Phase 1b/2a trials demonstrated that 14.3% of patients achieved complete bacterial clearance after just 10 days of treatment, including patients with chronic infections lasting over a decade [1][2] - Positive topline results from Part 2 of the Phase 1b/2a trial indicated improvements in pulmonary function associated with reduced P. aeruginosa burden compared to placebo in a predefined subgroup of patients [3]

Core Insights - BiomX's phage therapy platform has received validation through a peer-reviewed article published in Nature Communications, showcasing the results of a first-in-human Phase 1b/2a trial for treating antibiotic-resistant P. aeruginosa infections [1][2] - The trial demonstrated a significant bacterial reduction of 2.7 log₁₀ (approximately 500-fold) compared to placebo, with no emergence of bacterial resistance and preservation of a healthy microbiome [1][9] - BiomX is advancing its Phase 2b trial of BX004, with topline results expected in Q1 2026 [1][2] Company Overview - BiomX Inc. is a clinical-stage company focused on developing natural and engineered phage therapies targeting specific pathogenic bacteria, particularly for chronic diseases with substantial unmet needs [7] - The company utilizes its BOLT platform to customize phage compositions against proprietary bacterial targets [7] Clinical Trial Highlights - The Phase 1b/2a study evaluated the safety, tolerability, pharmacokinetics, and anti-microbiologic activity of BX004 over a 7-day treatment period in nine cystic fibrosis patients [4] - BX004 demonstrated a strong safety profile with no treatment-related safety events and achieved a 2.7 log₁₀ reduction in P. aeruginosa bacteria compared to placebo [4][9] - Therapeutic phages were successfully detected and persisted at the infection site in treated patients, indicating effective delivery and activity [4] Scientific Validation - The study employed large-scale genomic analysis and bacterial defense mechanisms to optimize bacteriophage cocktails for chronic infections associated with cystic fibrosis [3] - The publication details the translational path from laboratory discovery to clinical testing, confirming the absence of known antibiotic resistance or virulence genes in the phages used [5] Future Developments - BiomX is currently enrolling patients in a randomized, placebo-controlled Phase 2b trial of BX004, which will assess lung function, bacterial load, and quality of life metrics over an 8-week period [6] - BX004 has received Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration, indicating its potential significance in treating chronic pulmonary infections [6]

Core Insights - BiomX Inc. is presenting positive topline results from its Phase 2 trial evaluating BX211 for the treatment of Diabetic Foot Osteomyelitis (DFO) at the Biomed Israel 2025 conference [1][2] - BX211 is a phage therapy targeting DFO associated with Staphylococcus aureus, a significant cause of amputation in diabetic patients [3][4] Presentation Details - The oral presentation titled "Precision Phage Therapy for Chronic Diabetic Foot Infections" will take place on May 21, 2025, from 12:15 to 2:15 pm IST at the InterContinental David Tel Aviv [2] - The session focuses on immunology and inflammation, highlighting opportunities in biopharma [2] BX211 Trial Results - The Phase 2 trial demonstrated that BX211 was safe and well-tolerated, with a statistically significant reduction in ulcer size (p = 0.046 at week 12; p = 0.052 at week 13) [3] - A separation from placebo was observed starting at week 7, with a difference greater than 40% by week 10 [3] - Statistically significant improvements were also noted in ulcer depth (p=0.048) and reduction of ulcer area expansion (p=0.017) [3] - The treatment period lasted 12 weeks, during which all patients received standard care, including systemic antibiotic therapy [3] Company Overview - BiomX is a clinical-stage company focused on developing natural and engineered phage therapies for chronic diseases with unmet medical needs [4] - The company utilizes its BOLT platform to customize phage compositions targeting specific bacterial pathogens [4]

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]