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BiomX(PHGE) - 2025 Q2 - Quarterly Report
2025-08-13 13:12
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarter ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38762 BiomX Inc. (Exact Name of Registrant as Specified in Its Charter) | Delaware | 82-3364020 | | --- | --- | | (State or other jurisdicti ...
BiomX(PHGE) - 2025 Q2 - Earnings Call Transcript
2025-08-13 13:00
BiomX (PHGE) Q2 2025 Earnings Call August 13, 2025 08:00 AM ET Speaker0Good morning and welcome to the BioMix Second Quarter twenty twenty five Financial Results and Business and Program Update Conference Call. Currently, all participants are in a listen only mode. At the end of this call, there will be a question and answer session. As a reminder, this conference call is being recorded. I would now like to turn the call over to Marina Wolfson, Chief Financial Officer of BioMix.Please proceed.Speaker1Thank ...
BiomX(PHGE) - 2025 Q2 - Quarterly Results
2025-08-13 11:24
Exhibit 99.1 ● BiomX reported positive topline results from the Phase 2 trial of BX211 in March 2025 just prior to the start of the second quarter, demonstrating that BX211 was safe and well-tolerated and produced sustained and statistically significant percentage area reduction (PAR) of ulcer size (p = 0.046 at week 12; p=0.052 at week 13) with separation from placebo starting at week 7 and a difference greater than 40% by week 10. BX004 – Fixed phage cocktail for chronic Pseudomonas aeruginosa (P. aerugin ...
BiomX Reports Second Quarter 2025 Financial Results and Provides Program Updates
Globenewswire· 2025-08-13 10:30
Positive Phase 2 results for BX211 demonstrated >40% wound size reduction vs. placebo in diabetic foot osteomyelitis patients; Planning underway for potential registrational study Nature Communications publication of new BX004 Phase 1b/2a data demonstrated further ~500-fold (2.7 log₁₀)2 bacterial reduction versus placebo with no detectable emergence of resistance observed, highlighting strength of BiomX platform capabilitiesPhase 2b trial of BX004 in Cystic Fibrosis (CF) has successfully commenced patient d ...
BiomX to Report Second Quarter 2025 Financial Results and Program Updates on August 13, 2025
Globenewswire· 2025-08-06 12:30
NESS ZIONA, Israel, Aug. 06, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that it will report its second quarter 2025 financial results and program updates before the open of the U.S. financial markets on Wednesday, August 13, 2025. The Company will host a conference call and a live audio webcast at 8 a.m. ET, to discuss the second ...
BiomX Announces Publication in Nature Communications of Phage Cocktail BX004 Phase 1b/2a Part 1 Data Demonstrating Strong Activity in Cystic Fibrosis
GlobeNewswire News Room· 2025-07-08 12:30
Premier research journal article provides validation for BiomX’s phage therapy platform, showcasing first-in-human Phase 1b/2a trial results for antibiotic-resistant P. aeruginosa infectionsNew, updated data demonstrates a further bacteria reduction of 2.7 log₁₀ (approximately 500-fold) compared to placebo, with no emergent resistance and preservation of a healthy microbiomeBiomX is advancing its Phase 2b trial of BX004 with topline results expected Q1 2026 NESS ZIONA, Israel, July 08, 2025 (GLOBE NEWSWIRE) ...
BiomX CEO Jonathan Solomon to Present at Biomed Israel 2025 Conference
Globenewswire· 2025-05-19 14:02
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]
BiomX Inc. (PHGE) Q1 2025 Earnings Conference Call Transcript
Seeking Alpha· 2025-05-15 20:57
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]
BiomX(PHGE) - 2025 Q1 - Quarterly Report
2025-05-15 20:01
[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)
BiomX(PHGE) - 2025 Q1 - Earnings Call Transcript
2025-05-15 19:02
BiomX (PHGE) Q1 2025 Earnings Call May 15, 2025 02:00 PM ET Company Participants Marina Wolfson - CFO & SecretaryJonathan Solomon - CEO & Board Member Conference Call Participants Joseph Pantginis - MD & Senior Healthcare AnalystYale Jen - Senior Managing Director & Senior Biotech Analyst Operator Greetings, and welcome to the BioMix First Quarter twenty twenty five Financial Results Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the form ...