BiomX Inc. (PHGE) is a clinical-stage company leading the development of innovative phage-based therapies to target specific pathogenic bacteria. With a focus on chronic diseases, BiomX is leveraging its proprietary research and development platform, BOLT, to create novel treatments that address significant unmet medical needs.
Company History and Developments BiomX was incorporated in 2017 and has since established itself as a pioneer in the field of phage therapy. The company's headquarters are located in Ness Ziona, Israel, where the majority of its operations and key employees are based. BiomX's shares of common stock are traded on the NYSE American under the symbol PHGE. The company is developing natural and engineered phage cocktails designed to target and destroy harmful bacteria in chronic diseases, with a focus on cystic fibrosis and diabetic foot osteomyelitis.
In October 2023, an unprecedented attack was launched against Israel by terrorists from the Hamas terrorist organization, leading to a declaration of war by Israel against Hamas and a military campaign. While BiomX's operations have not been adversely affected so far, the intensity and duration of the war is difficult to predict and could potentially impact the company's business and operations in the future.
In March 2024, BiomX made a strategic move by acquiring Adaptive Phage Therapeutics LLC (APT), a Delaware-based, clinical-stage biotechnology company. This acquisition integrated APT's operations and expanded BiomX's pipeline, which now includes two Phase 2 assets targeting serious infections. The acquisition was structured as a stock-for-stock transaction, with APT becoming a wholly-owned subsidiary of BiomX.
One of BiomX's lead product candidates is BX004, a therapeutic phage cocktail developed for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa in cystic fibrosis (CF) patients. The company has reported positive results from the Phase 1b/2a trial of BX004, which demonstrated safety, tolerability, and microbiological activity. BiomX expects to initiate a Phase 2b study for BX004 in the fourth quarter of 2024.
Another key program in BiomX's pipeline is BX211, a personalized phage therapy for the treatment of diabetic foot osteomyelitis (DFO) associated with Staphylococcus aureus. The ongoing Phase 2 trial for BX211 has completed patient enrollment, and the company anticipates reporting topline results in the first quarter of 2025.
Financial Overview and Liquidity As of September 30, 2024, BiomX had cash, cash equivalents, and short-term deposits of approximately $24.7 million. The company's net cash used in operating activities for the nine months ended September 30, 2024, was $30.7 million, compared to $15.0 million for the same period in 2023.
In March 2024, BiomX raised $50 million in a private placement financing, which included the issuance of Redeemable Convertible Preferred Shares and Private Placement Warrants. This financing, along with the company's existing resources, is expected to fund BiomX's operations into the fourth quarter of 2025. The proceeds from this financing were used to support BiomX's ongoing research and development activities, as well as for other general corporate purposes.
For the third quarter of 2024, BiomX reported revenue of -$84,000 and a net income of -$9,642,000. Operating cash flow for the quarter was -$8,096,999, while free cash flow was -$8,107,000. The decrease in these financial metrics compared to the prior year quarter was primarily due to increased research and development expenses related to the company's clinical trials for BX004 and BX211, as well as higher general and administrative costs following the acquisition of Adaptive Phage Therapeutics.
Research and development expenses, net of grants, for the nine months ended September 30, 2024, were $18.28 million, compared to $14.02 million for the same period in 2023. General and administrative expenses increased to $8.76 million from $6.05 million in the prior year period, primarily due to costs associated with the acquisition of Adaptive Phage Therapeutics and the March 2024 private placement.
The company recorded a goodwill impairment of $801,000 during the third quarter of 2024 due to a decline in its stock price and market capitalization. This impairment charge was related to the acquisition of Adaptive Phage Therapeutics.
As of September 30, 2024, BiomX had a current ratio and quick ratio of 3.17, indicating a strong short-term liquidity position. The company had no outstanding debt as of the end of Q3 2024.
Product Segments and Development Pipeline BiomX operates primarily through two product segments:
1. Cystic Fibrosis (CF) Program: The company's lead product candidate, BX004, is a therapeutic phage product developed to treat chronic pulmonary infections caused by Pseudomonas aeruginosa in CF patients. In the Phase 1b/2a trial, BX004 demonstrated a reduction in P. aeruginosa colony forming units compared to placebo, with no safety issues related to treatment. BiomX plans to initiate a randomized, double-blind, placebo-controlled Phase 2b study in CF patients with chronic P. aeruginosa pulmonary infections in Q4 2024. However, due to manufacturing delays that have since been resolved, the study results are now expected in the first half of 2026.
2. Diabetic Foot Osteomyelitis (DFO) Program: BX211 is a personalized phage therapy targeting Staphylococcus aureus for the treatment of DFO. The ongoing randomized, double-blind, placebo-controlled Phase 2 trial is evaluating the safety, tolerability, and efficacy of BX211 in subjects with DFO associated with S. aureus. The first readout of topline results is expected in Q1 2025, followed by a second readout at week 52 in Q1 2026, evaluating wound healing, amputation rates, and resolution of osteomyelitis.
Challenges and Risks BiomX's operations and financial performance are subject to various risks and challenges, including:
1. Political, economic, and military instability in Israel: The company's headquarters and the majority of its operations are located in Israel, which has experienced ongoing conflicts and tensions in the region, including the recent war with Hamas and Hezbollah. These geopolitical uncertainties could potentially disrupt the company's business and operations.
2. Manufacturing delays: During the third quarter of 2024, BiomX experienced manufacturing delays for its BX004 product candidate, which resulted in a revised timeline for the Phase 2b study. The company has since resolved these manufacturing issues, but future delays could impact the development of its pipeline.
3. Reliance on government funding: BiomX has received significant non-dilutive funding from institutions such as the Israel Innovation Authority (IIA) and the U.S. Defense Health Agency (DHA) for its research and development activities. Any changes or disruptions to this funding could affect the company's financial resources and the progression of its programs.
4. Regulatory approval and commercialization: As a clinical-stage company, BiomX faces the inherent risks associated with the successful development, regulatory approval, and commercialization of its product candidates. Failure to achieve these milestones could adversely impact the company's financial performance and growth prospects.
Outlook and Conclusion BiomX is at an exciting juncture, with its pipeline of phage-based therapies addressing significant unmet medical needs in chronic diseases. The company's recent acquisition of APT and the positive results from its clinical trials have bolstered its position in the phage therapy landscape.
The company expects to report top-line results for the BX211 Phase 2 trial in diabetic foot osteomyelitis in the first quarter of 2025, and top-line results for the BX004 Phase 2b study in the first half of 2026. These milestones will be crucial in determining the future trajectory of BiomX's development programs.
BiomX's financial position remains stable, with current cash, cash equivalents, and short-term deposits expected to fund operations into the fourth quarter of 2025. However, the company's operations and financial stability remain subject to various challenges, including the ongoing geopolitical tensions in Israel, manufacturing hurdles, and the risks associated with the development and commercialization of its product candidates.
As BiomX navigates these obstacles and continues to advance its pipeline, investors will closely monitor the company's ability to execute on its strategic priorities and deliver meaningful clinical outcomes. The company's financial resources, coupled with its innovative approach to phage therapy, position BiomX as a compelling player in the fight against chronic bacterial infections.