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 March 31, 2024 ☐ 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 jurisdict ...

GAITHERSBURG, Maryland and NESS ZIONA, Israel, May 15, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE:PHGE) ("BiomX" or the "Company"), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that the Company will host a conference call and a live audio webcast on Tuesday, May 21, 2024, at 8:00 a.m. ET, to report first quarter 2024 financial results and provide business and program updates. To participate in the conference call, pl ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission file number: 0001-38762 BIOMX INC. (Exact name of registrant as specified in its charter) | Delaware | 82-3364020 | | --- | --- | | (State or othe ...

BiomX Inc. (NYSE:PHGE) Q4 2023 Earnings Conference Call April 3, 2024 8:00 AM ET Company Participants Avi Gabay - Interim CFO Jonathan Solomon - CEO Conference Call Participants Joseph Pantginis - H.C. Wainwright Operator Good morning, and welcome to the BiomX Full Year 2023 Financial Results and Corporate Update Conference Call. Currently, all participants are in a listen-only mode. There will be a question-and-answer session at the end of this call. I'd now like to turn the conference over to Avi Gabay, I ...

[Report Overview and Business Highlights](index=1&type=section&id=Report%20Overview%20and%20Business%20Highlights) BiomX acquired Adaptive Phage Therapeutics and secured $50 million in financing, strategically positioning itself as a leader in phage therapy [Key Business Developments](index=1&type=section&id=Key%20Business%20Developments) In a transformative year, BiomX acquired Adaptive Phage Therapeutics (APT) in March 2024, positioning itself as a leader in phage therapy, adding a second Phase 2 asset, BX211, to its pipeline, and securing $50 million in private placement financing to advance its lead programs, BX004 and BX211, through key clinical data readouts expected in 2025 - Acquired Adaptive Phage Therapeutics (APT) in March 2024, creating a leading phage therapy company with two Phase 2 assets: **BX004** for Cystic Fibrosis and **BX211** for Diabetic Foot Osteomyelitis (DFO)[4](index=4&type=chunk) - Closed a concurrent **$50 million** private placement financing led by investors including Deerfield Management, the AMR Action Fund, the Cystic Fibrosis Foundation, and Orbimed[1](index=1&type=chunk)[4](index=4&type=chunk) - The financing is expected to fund the company through key clinical milestones, including Phase 2b results for **BX004** (Q3 2025) and Phase 2 results for **BX211** (Q1 2025)[4](index=4&type=chunk) - The CEO highlighted 2023 as a year of great progress, emphasizing the positive Phase 1b/2a results for **BX004** in treating chronic P. aeruginosa infections in Cystic Fibrosis patients[3](index=3&type=chunk) [Clinical Program Updates](index=2&type=section&id=Clinical%20Program%20Updates) BiomX provides clinical updates on its pipeline, highlighting progress for BX004 and BX211, and the strategic reprioritization of BX005 [Cystic Fibrosis (BX004)](index=2&type=section&id=Cystic%20Fibrosis%20%28BX004%29) The BX004 program for Cystic Fibrosis (CF) achieved significant milestones, including receiving Orphan Drug Designation from the FDA in January 2024, with positive topline results from the Phase 1b/2a trial demonstrating that BX004 was safe and well-tolerated, showing 14.3% of patients in the treatment arm converted to sputum culture negative for P. aeruginosa, compared to 0% in the placebo arm, and a subgroup with reduced lung function showed clinical improvement - **BX004** was granted Orphan Drug Designation by the FDA for treating chronic pulmonary infections caused by P. aeruginosa in CF patients[7](index=7&type=chunk) - The Phase 1b/2a trial showed the drug was safe and well-tolerated, with no related serious adverse events[7](index=7&type=chunk) - Efficacy data showed **14.3%** (3 out of 21) of patients in the **BX004** arm converted to sputum culture negative for P. aeruginosa, versus **0%** (0 out of 10) in the placebo arm[7](index=7&type=chunk) - In a predefined subgroup with reduced baseline lung function (FEV1<70%), the **BX004** group showed a relative FEV1 improvement of **5.67%** compared to placebo[7](index=7&type=chunk) - No evidence of treatment-related phage resistance was observed in patients treated with **BX004**[7](index=7&type=chunk) [Diabetic Foot Osteomyelitis (BX211)](index=3&type=section&id=Diabetic%20Foot%20Osteomyelitis%20%28BX211%29) BX211, a personalized phage therapy for Diabetic Foot Osteomyelitis (DFO) associated with S. aureus, was added to the pipeline through the acquisition of APT, with a Phase 2 randomized, double-blind, placebo-controlled trial currently underway, having enrolled 32 of the targeted 45 patients, and initial topline results anticipated in the first quarter of 2025 - **BX211** is a personalized phage treatment acquired from APT for DFO associated with S. aureus[8](index=8&type=chunk) - A Phase 2 clinical trial is actively enrolling, with **32** out of a target of **45** patients enrolled to date[8](index=8&type=chunk) - Initial top-line results from the Phase 2 trial are expected in the first quarter of **2025**[1](index=1&type=chunk)[8](index=8&type=chunk) [Atopic Dermatitis (BX005)](index=3&type=section&id=Atopic%20Dermatitis%20%28BX005%29) The company has paused development efforts for its Atopic Dermatitis candidate, BX005, to prioritize resources towards the more advanced clinical programs for Cystic Fibrosis (BX004) and Diabetic Foot Osteomyelitis (BX211) - Development of **BX005** has been paused to prioritize resources for the CF and DFO programs[9](index=9&type=chunk) [Detailed Clinical Program Information](index=4&type=section&id=Detailed%20Clinical%20Program%20Information) Detailed clinical program information outlines development plans for BX004's Phase 2b trial and BX211's personalized approach with key readouts [About BX004](index=4&type=section&id=About%20BX004) BX004 is a fixed multi-phage cocktail designed to treat chronic pulmonary infections from P. aeruginosa in CF patients, with a pivotal Phase 2b trial set to begin in Q4 2024, enrolling approximately 60 patients, and the 8-week study assessing safety, reduction in bacterial load, and clinical outcomes like FEV1, with results expected in Q3 2025, and the candidate holding both Fast Track and Orphan Drug designations from the FDA - A randomized, double-blind, placebo-controlled Phase 2b trial is planned to initiate in **Q4 2024**[16](index=16&type=chunk) - The trial will enroll approximately **60** patients randomized 2:1 (**BX004** vs. placebo) with an 8-week treatment duration[16](index=16&type=chunk) - Primary endpoints will assess safety, tolerability, microbiological reduction of P. aeruginosa, and clinical effects on lung function (FEV1), with trial results expected in **Q3 2025**[16](index=16&type=chunk) [About BX211](index=4&type=section&id=About%20BX211) BX211 is a personalized phage therapy for DFO, tailoring treatment by selecting specific phages against the S. aureus strain isolated from each patient, with the ongoing Phase 2 trial enrolling ~45 subjects who will receive weekly treatment for 12 weeks alongside standard care, and two key readouts: the first in Q1 2025 for wound healing, and a second in Q1 2026 evaluating long-term outcomes like amputation rates and resolution of osteomyelitis - **BX211** is a personalized phage treatment where a specific phage is selected from a proprietary bank to match the patient's S. aureus strain[17](index=17&type=chunk) - The ongoing Phase 2 trial will administer **BX211** or placebo weekly for **12 weeks**, with all subjects also receiving standard of care, including antibiotics[19](index=19&type=chunk) - The trial has two primary readout points: Week 13 results on wound healing (expected **Q1 2025**) and Week 52 results on amputation rates and resolution of osteomyelitis (expected **Q1 2026**)[19](index=19&type=chunk) [Financial Results](index=3&type=section&id=Full%20Year%202023%20Financial%20Results) BiomX's 2023 financial results show a reduced net loss and significant post-year-end financing, alongside a 'going concern' warning [Full Year 2023 Financial Performance](index=3&type=section&id=Full%20Year%202023%20Financial%20Performance) BiomX reported a cash balance of $15.9 million at the end of 2023, a decrease from $34.3 million at the end of 2022, primarily due to operating activities, with the company's net loss for 2023 at $26.2 million, an improvement from the $28.3 million loss in 2022, and subsequent to year-end, the company raised $50 million and repaid a $10.4 million loan, though financial statements include a 'going concern' warning related to potential stockholder approval risks for convertible preferred stock Financial Metric Summary | Financial Metric | 2023 (USD in millions) | 2022 (USD in millions) | | :--- | :--- | :--- | | Cash, short-term deposits & restricted cash | 15.9 | 34.3 | | R&D Expenses, net | 16.7 | 16.2 | | G&A Expenses | 8.7 | 9.5 | | Net Loss | 26.2 | 28.3 | | Net Cash Used in Operating Activities | 21.3 | 29.1 | - Post-year-end, the company closed a **$50 million** financing and fully repaid a **$10.4 million** loan balance with Hercules Capital[12](index=12&type=chunk) - Financial statements contain a 'going concern' warning due to the risk that stockholders may not approve the conversion of preferred stock issued in the APT acquisition and financing[12](index=12&type=chunk) [Consolidated Balance Sheets](index=7&type=section&id=BIOMX%20INC.%20CONSOLIDATED%20BALANCE%20SHEETS) The consolidated balance sheet shows total assets of $25.0 million and total liabilities of $21.9 million as of December 31, 2023, resulting in total stockholders' equity of $3.1 million, compared to total assets of $45.5 million and stockholders' equity of $21.0 million at the end of 2022 BIOMX INC. CONSOLIDATED BALANCE SHEETS | (USD in thousands) | As of Dec 31, 2023 | As of Dec 31, 2022 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | 14,907 | 31,332 | | Total current assets | 17,632 | 36,881 | | Total non-current assets | 7,397 | 8,650 | | **Total Assets** | **25,029** | **45,531** | | **LIABILITIES & EQUITY** | | | | Total current liabilities | 11,176 | 7,939 | | Total non-current liabilities | 10,772 | 16,553 | | **Total Liabilities** | **21,948** | **24,492** | | **Total Stockholders' equity** | **3,081** | **21,039** | | **Total Liabilities and Equity** | **25,029** | **45,531** | [Consolidated Statements of Operations](index=8&type=section&id=BIOMX%20INC.%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) For the year ended December 31, 2023, the company reported an operating loss of $25.3 million and a net loss of $26.2 million, or $0.51 per share, representing a decrease in net loss compared to the $28.3 million, or $0.95 per share, reported for the full year 2022 BIOMX INC. CONSOLIDATED STATEMENTS OF OPERATIONS | (USD in thousands, except per share data) | Year ended Dec 31, 2023 | Year ended Dec 31, 2022 | | :--- | :--- | :--- | | R&D expenses, net | 16,698 | 16,244 | | General and administrative expenses | 8,650 | 9,456 | | **Operating loss** | **25,348** | **27,219** | | **Net Loss** | **26,169** | **28,317** | | Basic and diluted loss per share | 0.51 | 0.95 |

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 September 30, 2023 ☐ 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 juris ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Exact Name of Registrant as Specified in Its Charter) 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, 2023 ☐ 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. | Delaware | 82-3364020 | | --- | --- | | (State or other jurisdicti ...

BiomX Inc. (NYSE:PHGE) Q2 2023 Earnings Conference Call August 9, 2023 8:00 AM ET Company Participants Marina Wolfson - Chief Financial Officer Jonathan Solomon - Chief Executive Officer Conference Call Participants Joe Pantginis - H.C. Wainwright Michael Higgins - Ladenburg Thalmann Operator Good morning and welcome to the BiomX Second Quarter 2023 Financial Results and Corporate Update Conference Call. Currently, all participants are in a listen-only mode. There will be a question-and-answer session at t ...

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 | Delaware | 82-3364020 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer | | incorporation or organization) | Identification No.) | | 22 Einstein St., 4 Floor, Ness Ziona, Israel | 7414003 | (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: +972 723942377 ...

BiomX Inc. (NYSE:PHGE) Q1 2023 Results Conference Call May 15, 2023 8:00 AM ET Company Participants Marina Wolfson - CFO Jonathan Solomon - CEO Conference Call Participants Joe Pantginis - H.C. Wainwright Michael Higgins - Ladenburg Thalmann Operator Good morning, and welcome to the BiomX First Quarter 2023 Financial Results and Corporate Update Conference Call. Currently, all participants are in a listen-only mode. There will be a question-and-answer session at the end of this call. I would now like to tur ...