BiomX Inc. (PHGE) is a clinical-stage biopharmaceutical company leading the development of novel natural and engineered phage therapies to target specific pathogenic bacteria. With a focus on chronic diseases such as cystic fibrosis (CF) and diabetic foot osteomyelitis (DFO), BiomX is leveraging the unique capabilities of bacteriophages, or "phage," to address the growing challenge of antibiotic resistance.
Business Overview and Detailed Company History
BiomX was incorporated in 2017 and is headquartered in Ness Ziona, Israel. The company's shares trade on the NYSE American exchange under the ticker symbol PHGE. BiomX's mission is to develop phage-based treatments that can precisely target and eliminate harmful bacteria, offering a potential solution to the global crisis of antibiotic resistance.
In March 2024, BiomX completed the acquisition of Adaptive Phage Therapeutics (APT), a U.S.-based, privately held clinical-stage biotechnology company. This transformative deal expanded BiomX's pipeline and added two Phase 2 assets targeting serious infections with unmet medical needs. The combined entity now has a diversified portfolio of phage-based product candidates, with a focus on CF and DFO. Concurrently with the acquisition, BiomX also completed a $50 million private placement financing, strengthening its financial position.
In July 2024, BiomX's stockholders approved the conversion of the company's outstanding Series X Non-Voting Convertible Preferred Stock, which was issued as part of the APT acquisition and the concurrent financing, into shares of BiomX's common stock. This conversion simplified the company's capital structure.
BiomX's proprietary BOLT (BacteriOphage Lead to Treatment) platform is the foundation of its innovative approach. The BOLT platform leverages cutting-edge methodologies across computational biology, microbiology, synthetic phage engineering, bioanalytical assay development, manufacturing, and formulation. This allows the company to efficiently screen, identify, and combine different phage, both naturally occurring and synthetically engineered, to develop optimized phage cocktails.
The company operates in two main product segments:
1. Fixed Cocktail Therapy: This approach involves developing a single product containing a fixed number of selected phages to cover a wide range of bacterial strains, allowing for broad patient treatment with the same product. BiomX utilizes its proprietary BOLT platform to create optimized cocktails.
2. Personalized Therapy: In this approach, BiomX develops a large library of phages and matches an optimal phage to treat specific patients. The company's proprietary phage susceptibility testing analyzes multiple considerations to efficiently screen the phage library while maintaining short turnaround times.
The company's lead product candidates are BX004 for the treatment of chronic Pseudomonas aeruginosa infections in CF patients, and BX211 for the treatment of DFO associated with Staphylococcus aureus. Both programs have shown promising results in early-stage clinical trials and are advancing towards pivotal studies.
Financials
As of September 30, 2024, BiomX reported cash, cash equivalents, and short-term deposits of $24.7 million. The company's current ratio stood at 3.17, indicating a strong liquidity position. However, the company has accumulated a deficit of $166.2 million since its inception and does not expect to generate significant revenue from product sales in the near term.
For the third quarter of 2024, BiomX reported a revenue of -$84,000 and a net loss of $9.64 million. The decrease in revenue and increased net loss were primarily due to higher research and development expenses for the BX004 and BX211 clinical programs, as well as increased general and administrative costs related to the acquisition of Adaptive Phage Therapeutics. The company also recorded a $801,000 goodwill impairment charge in Q3 2024.
BiomX reported net cash used in operating activities of $30.69 million for the nine months ended September 30, 2024, primarily driven by R&D and general and administrative expenses.
Liquidity
BiomX's management estimates that the current cash resources will be sufficient to fund operations into the fourth quarter of 2025. To support its ongoing research and development activities, the company plans to seek additional financing through public or private equity offerings, debt financing, government grants, and potential strategic collaborations.
As of September 30, 2024, the company had $23.54 million in cash and cash equivalents and $1.11 million in restricted cash, for a total of $24.65 million in cash, cash equivalents and restricted cash. The company's debt-to-equity ratio was 0.26, and both its current ratio and quick ratio stood at 3.17, indicating a strong short-term liquidity position.
In March 2024, BiomX prepaid its $10.43 million loan facility with Hercules Capital, further improving its balance sheet.
Recent Developments and Upcoming Milestones
In the third quarter of 2024, BiomX experienced some manufacturing delays for its BX004 program, which led to a revised timeline for the Phase 2b study in CF patients. The top-line results for this study are now expected in the first half of 2026, rather than the originally anticipated timeframe.
Despite the manufacturing challenges, BiomX has made significant progress in its pipeline. In the third quarter, the company completed patient enrollment for the Phase 2 trial of BX211 in DFO. The top-line results from this study are expected in the first quarter of 2025, which will be a key milestone for the company.
Furthermore, BiomX presented positive safety and efficacy data from the Phase 1b/2a trial of BX004 at several scientific conferences during the third quarter. The data showed promising microbiological and clinical outcomes, strengthening the company's confidence in the future of this program.
In March 2024, BiomX raised $50 million through a private placement financing, which, combined with the proceeds from the APT acquisition, provided the company with the necessary funding to advance its clinical programs. The company also implemented a 1-for-10 reverse stock split in August 2024 to regain compliance with the NYSE American's continued listing standards.
Risks and Challenges
BiomX's operations in Israel expose the company to political, economic, and military instability in the region, including the ongoing conflict with Hamas and Hezbollah. Any escalation of hostilities or disruptions to the company's facilities and workforce could have a material adverse impact on its business and operations.
The development of phage-based therapies also carries inherent risks, such as the unpredictable nature of the phage-bacteria interactions, potential regulatory hurdles, and challenges in scaling up manufacturing processes. BiomX's ability to successfully navigate these obstacles will be crucial for the advancement of its pipeline.
Additionally, the company's reliance on government grants and the ability to raise additional capital through equity or debt offerings represent significant risks, as the availability and terms of such funding may be limited or unfavorable, especially in the current economic environment.
Conclusion
BiomX is at the forefront of the phage therapy field, leveraging its proprietary BOLT platform to develop innovative treatments for chronic bacterial infections. The company's diversified pipeline, led by the promising BX004 and BX211 programs, positions it well to address the growing challenge of antibiotic resistance. The acquisition of Adaptive Phage Therapeutics has further strengthened BiomX's position in the field, expanding its pipeline and adding valuable assets to its portfolio.
While the company faces significant risks, including geopolitical tensions in Israel, regulatory uncertainties, and the need for additional financing to fund its ongoing research and development efforts, BiomX's strong liquidity position and focused strategy provide a solid foundation for future growth. The company's ability to advance its clinical programs, particularly the Phase 2b study of BX004 and the Phase 2 trial of BX211, will be critical in determining its long-term success.
Investors should closely monitor BiomX's progress as it navigates these challenges and works to bring its phage-based therapies to the market. The upcoming milestones, including the top-line results for the BX211 Phase 2 trial in Q1 2025 and the BX004 Phase 2b study in the first half of 2026, will be key indicators of the company's potential to revolutionize the treatment of chronic bacterial infections and address the growing threat of antibiotic resistance.