Core Viewpoint - BiomX Inc. has received approval from its stockholders to convert its Series X Non-Voting Convertible Preferred Stock into common stock, which is expected to enhance its compliance with NYSE American listing requirements [1][2][5]. Group 1: Stockholder Vote and Conversion - The stockholder vote approved the conversion of BiomX's Series X Preferred Stock into common stock, allowing for the conversion of up to 256,887 shares into 256,887,000 shares of common stock [5]. - This conversion is a result of the financing associated with the acquisition of Adaptive Phage Therapeutics, Inc. and is expected to positively impact the company's balance sheet by classifying certain proceeds as stockholders' equity [2][5]. Group 2: Compliance with NYSE American - Following the stockholder vote, BiomX anticipates regaining compliance with NYSE American's requirement for listed companies to maintain stockholders' equity of at least $2 million [2]. - The company had previously been notified of non-compliance and submitted a plan to address this issue, awaiting acceptance from NYSE American [2]. Group 3: Company Overview and Future Prospects - BiomX is focused on developing novel phage therapies targeting pathogenic bacteria, with two advanced Phase 2 clinical candidates expected to have significant readouts in the coming year [6]. - The company utilizes its BOLT platform to customize phage compositions against proprietary bacterial targets, aiming to address chronic diseases with unmet medical needs [6].

GAITHERSBURG, Md. and NESS ZIONA, Israel, May 30, 2024 (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 received written notification ("the Notice") from the NYSE American LLC ("NYSE American"), dated May 23, 2024, stating that the Company is no longer in compliance with continued listing standards, as set forth in Sections 1003(a) ...

GAITHERSBURG, Md. and NESS ZIONA, Israel, May 30, 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 the Company will present at two upcoming conferences data from BiomX's Phase 1b/2a study of BX004 for the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infections. The findings will be presented in an oral pres ...

GAITHERSBURG, Md. and NESS ZIONA, Israel, May 21, 2024 (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 reported financial results and provided business and program updates for the first quarter ended March 31, 2024. BiomX is announcing merged financial reporting for the first time following the closing of its merger with Adaptive Phage Therapeutics, ...

Following merger with Adaptive Phage Therapeutics in March, combined company reports funding sufficient to support important data readouts for lead clinical programs in 2025 Company will host a conference call and webcast today at 8:00 am ET Cystic Fibrosis (BX004) In January 2024, the Company announced that BX004 was granted Orphan Drug Designation by the United States Food and Drug Administration ("FDA"), for the treatment of chronic pulmonary infection caused by P. aeruginosa in patients with CF. In Apri ...

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 ...

Financial Data and Key Metrics Changes - As of December 31, 2023, cash balance and short-term deposits were $15.9 million, down from $34.3 million as of December 31, 2022, primarily due to net cash used in operating activities [30] - R&D expenses net for 2023 were $16.7 million, compared to $16.2 million in the previous year, mainly due to increased expenses related to the CF clinical trial [31] - Net loss for 2023 was $26.2 million, compared to $28.3 million for the prior year, with net cash used in operating activities for 2023 at $21.3 million, down from $29.1 million in 2022 [32] Business Line Data and Key Metrics Changes - The acquisition of APT added a second Phase 2 product candidate, BX211, for the treatment of diabetic foot osteomyelitis, enhancing the company's pipeline [22] - BX004 has demonstrated safety and proof-of-concept efficacy in the Phase 1b/2a study, with data readouts expected in 2025 for both BX004 and BX211 [35] Market Data and Key Metrics Changes - The estimated commercial opportunity for BX211 in the U.S. is $1 billion and over $2 billion worldwide, targeting Staphylococcus aureus infections, which compromise approximately 50% of diabetic foot osteomyelitis cases [9] Company Strategy and Development Direction - The company is focused on advancing its clinical programs, particularly BX004 and BX211, with significant milestones expected in the coming years [40] - The company plans to hold a Type C meeting with the FDA in the second quarter of 2024 to discuss the clinical development plan for BX004 [19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2024 being a substantial year for the company, with the completion of the APT acquisition and a $50 million investment from institutional investors [40] - There is a recognition of the high unmet need in diabetic foot osteomyelitis, with approximately 160,000 lower limb amputations in diabetic patients annually in the U.S. [27] Other Important Information - The company has sufficient cash and equivalents to fund its current operating plan for at least the next 12 months, despite a note of substantial doubt about its ability to continue as a going concern [33] - General and administrative expenses decreased to $8.7 million for 2023 from $9.5 million in the prior year, primarily due to a reduction in directors and officer insurance premiums [37] Q&A Session Summary Question: Update on efficiencies post-merger - Management indicated that the integration process is ongoing, with evaluations of redundancies taking place, and expressed satisfaction with the APT team's work [43] Question: Insights on DFO and amputation rates - Management acknowledged that amputation is a complex endpoint and emphasized a focus on shorter-term outcomes like ulcer shrinkage in the current study [45] Question: Additional data analysis from Phase 2 for BX004 - Management stated that no new guidance is available yet but mentioned plans to present data at top conferences and highlighted the importance of the upcoming FDA meeting [51]

[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 |