BiomX (NYSE:PHGE) has announced significant advancements in its clinical programs, including positive results from its BX004 study and the completion of the Adaptive Phage Therapeutics acquisition. The biotech company successfully raised $50 million in a private placement, which, along with its existing capital, is expected to fund its operations and clinical milestones for the next two years. Despite a solid financial plan and promising product candidates, BiomX faces uncertainty regarding the conversion of preferred stock, casting doubt on its long-term financial stability.
Key Takeaways
- BiomX reported positive results from its Phase 1b/2a study of BX004.
- The company completed the acquisition of Adaptive Phage Therapeutics, adding BX211 to its pipeline.
- $50 million was raised in a private placement to support upcoming clinical milestones.
- BiomX expects to have enough funding for the next two years, with critical data readouts for BX211 and BX004 slated for 2025.
- A potential commercial opportunity for BX211 is estimated at over $1 billion in the US.
- BiomX is set for a Type C FDA meeting in Q2 2024 to discuss BX004's development plan.
- As of December 31, 2023, BiomX had $15.9 million in cash and short-term deposits.
- Financial statements reveal concerns about the company's ability to continue due to risks associated with stockholder approval of convertible preferred stock conversion.
Company Outlook
- BiomX is optimistic about advancing BX004 and BX211, with data expected in 2025.
- New leadership has been added to the Board of Directors to enhance clinical development and capital optimization.
- The company plans to engage with the FDA in mid-2024 to discuss clinical plans.
Bearish Highlights
- There's substantial doubt about the company's ability to continue as a going concern.
- The conversion of convertible preferred stock issued during the APT acquisition poses a potential risk.
Bullish Highlights
- BiomX has secured sufficient funding to reach multiple clinical milestones over the next two years.
- The acquisition of APT and the addition of BX211 to the pipeline bolster BiomX's product offerings.
Misses
- Concerns were raised about the approval of the conversion of convertible preferred stock, which is critical for the company's financial stability.
Q&A Highlights
- The company is focusing on shorter study time frames, looking at ulcer shrinkage and healing as endpoints.
- Ongoing research into surrogate endpoints could potentially shorten study time frames.
- BiomX plans to follow patients for extended periods and discuss findings with the FDA.
- Upcoming conferences and an FDA meeting are scheduled for mid-year.
BiomX (ticker: PHGE), with its recent clinical and financial achievements, aims to tackle the high unmet need in diabetic foot osteomyelitis (DFO) and cystic fibrosis (CF). The successful completion of its study on BX004 and the addition of BX211 to its pipeline through the APT acquisition mark significant strides in the company's journey. The financial boost from the private placement led by Deerfield Management and others provides a runway for the company's operations and clinical trials. However, the looming uncertainty over the conversion of convertible preferred stock and the need for stockholder approval highlight the challenges BiomX faces in maintaining its financial health. The company's strategic focus on advancing its clinical programs and optimizing capital resources, as evidenced by the addition of new leadership, underscores its commitment to achieving its goals despite the financial concerns. With key data readouts expected in 2025 and ongoing discussions with the FDA, BiomX continues to progress in its mission to bring innovative treatments to market.
InvestingPro Insights
BiomX (ticker: PHGE) has shown resilience and progress in its clinical developments, but its financial health remains a point of focus for investors. According to the latest data from InvestingPro, BiomX holds a market capitalization of $16.53 million, indicating a relatively small size within the biotech industry. The company's Price to Earnings (P/E) ratio stands at -0.58, reflecting its current lack of profitability, which is consistent with the challenges faced by many early-stage biotech firms.
InvestingPro Tips for BiomX highlight that the company holds more cash than debt on its balance sheet, which is a positive indicator of financial prudence, especially for a company in a capital-intensive phase of clinical trials. However, analysts are not anticipating BiomX to be profitable this year, underlining the importance of the company's strategic financial management and the need for successful clinical outcomes to attract further investment.
The company's stock has experienced a significant return over the last week, month, and three months, with respective total price returns of 7.9%, 80.38%, and 41.77%. This volatility may attract traders looking for short-term gains, but it also underscores the inherent risks associated with investing in the biotech sector.
For readers looking to delve deeper into BiomX's financial metrics and gain additional insights, InvestingPro offers a range of tips that can help investors make informed decisions. By using the coupon code PRONEWS24, readers can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, gaining access to an array of valuable InvestingPro Tips that can further enrich their investment strategy. There are 10 additional tips listed on InvestingPro for BiomX, providing a comprehensive analysis of the company's financial and operational status.
Full transcript - Biomx Inc (PHGE) Q4 2023:
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, Interim Chief Financial Officer of BiomX. Avi, please proceed sir.
Avi Gabay: Thank you, and welcome to the BiomX full year 2023 financial results and corporate update conference call. The news release became available just after 6:30 a.m. Eastern Time today, and can be found in our website at www.biomix.com. A replay of this call will also be available in the Investors Section for our website. Before we begin, I'd like to review the Safe Harbor provision. All statements on this call that are not factual historic statements may be deemed forward-looking statements. For instance, we are using forward-looking statements when we discuss on the conference call, the sufficiency of the combined company's financing, potential stockholders' approval of certain matters related to the securities issue, and related matters in connection with the Adaptive Phage Therapeutics or APT acquisition, potential market opportunities, the ability to drive value for stockholders, the design, aim, expected timing, and interim and final results of our preclinical and clinical trials, the regulatory process and discussion with the FDA, the potential benefits and commercial opportunities for product candidates, and the potential safety or efficacy, of BX004 and BX211. In addition, past and current preclinical and clinical results, as well as compassionate use are not indicative and do not guarantee future success of our clinical trials. Except as required by law, we do not undertake to update forward-looking statements. The full Safe Harbor provision, including risks that could cause actual results, to differ from these forward-looking statements are outlined in today's press release, which as noted earlier, is on our website. Joining me on the call this morning is Jonathan Solomon, Chief Executive Officer of BiomX. With that, I will turn the call over to Jonathan.
Jonathan Solomon: Good morning, everyone. The fourth quarter of 2023, proved to be one of the most significant and exciting periods of our company, highlighted by the positive results from Part 2 of our Phase 1b/2a study of BX004. Soon after achieving this major clinical milestones, we announced the transformational acquisition of APT in March, adding to our pipeline a second Phase 2 product candidate, BX211, for the treatment of diabetic foot osteomyelitis. In connection with this acquisition, we also raised $50 million in the private placement led by affiliates of Deerfield Management, AMR Action Fund with the participation of additional existing and new investors, including the Cystic Fibrosis Foundation, Orbimed, and Nantahala Capital. We deeply value and appreciate the support, from these widely respected institutional investors. Including net proceeds from the financing and our existing capital, BiomX now expects to have sufficient funding, to reach multiple clinical milestones over the next two years, including expected data readouts for BX211 and BX004, in the first quarter of 2025 and third quarter of 2025, respectively. With approximately 80 compassionate use cases, multiple clinical studies and INDs, the combined company possesses an extraordinary depth, of clinical experience in developing phage products, along with the expertise in regulatory affairs, to help further advance these programs into pivotal testing. The acquisition created a leading phage company, with one of the most advanced pipelines of phage-based therapeutics, which includes two clinical phage products, each having the potential to advance the standard of care in the respective disease area. As noted, the combined company has two significant Phase 2 readouts anticipated in 2025 which, if successful, could potentially drive significant value for stockholders. I would like to spend more time today, focusing on our new program in diabetic foot osteomyelitis or DFO, and our ongoing Phase 2 clinical study. The study has already surpassed 70% of our targeted enrollment, and we remain on track to report the Week 13 treatment results, in the first quarter of 2025. Ulcers in patients with diabetes, are a complication caused by a combination of poor blood circulation, susceptibility to infection and nerve damage from high blood sugar levels. When there is limited blood flow to the wounded area, the body struggles to heal its wounds. So these wounds develop into diabetic ulcers. Once infected the ulcer deepens, to the extent that it spreads into the bone, the condition is classified as DFO, which is a very serious condition that could lead to lower limb amputation. DFO standard of care often includes offloading of pressure from the foot, debridement surgery and up to a six-week course of topical oral or IV antibiotic therapy. Unfortunately, 30% to 40% of DFO cases fail leading to amputations, depending upon the location of the infected bone, amputations often result in the loss of a toe, or in more severe cases the loss of a limb below, or above the ankle. With a staggering number of approximately 160,000 lower limb amputations in diabetic patients annually in the U.S. alone, 85% of which are caused by DFO, according to the Center of Disease Control and literature this remains an area of a high unmet need. One of the main reasons, for the limited effectiveness of antibiotic therapy, is poor delivery as a therapy to the infected bone. Biofilm, a polysaccharide mesh secreted by bacteria infecting the bone and ulcer, creates a barrier that inhibits antibiotic penetration in these patients, who already suffer from poor blood circulation. Beyond delivery antibiotic resistance, is an additional contributing factor to the limited effectiveness of antibiotic treatment. For example, according to literature approximately 40% of Staphylococcus aureus infections are MRSA, a Methicillin-resistant Staphylococcus aureus. Phage therapy has the potential to address, these key drivers for treatment failure. When properly selected phage effectively target and kill antibiotic-resistant bacterial strains, and have the capacity to breakdown biofilm. For example, phage were selected for the treatment of patients under our current DFO study, were found when sequenced to have multiple domains of catalytic activity, against Staphylococcal biofilm components. Moreover, a main factor that supports phage risk therapeutic approach to improve treatment outcomes in DFO, are the positive results from numerous compassionate cases using phage therapy. Out of 12 cases reported in scientific literature, 11 resulted in positive outcome of wound healing and avoiding amputation. BX211 developed under APT's technology platform, is based on personalized approach, which utilizes one of the largest phage banks in the world, to optimally pair individualized phage therapy to the specific strains of bacteria, as biopsied from the patient. The treatment targets, Staphylococcus aureus, which is considered the most common bacterial infection in DFO, compromising approximately 50% of cases and is considered the most pathogenic bacteria, due to its rapid doubling time in arsenal of virulence factors. We estimate that BX211, represents a commercial opportunity of $1 billion in the U.S. and over $2 billion worldwide. We are now conducting a randomized double-blind placebo-controlled multicenter Phase 2 study, investigating the safety, tolerability and efficacy of BX211 in subjects, with DFO associated with Staph aureus. Approximately 45 subjects are planned to be randomized at a 2:1 ratio to BX211 or placebo. BX211 or placebo, is administered weekly by topical and IV route at week one, and by the topical route only at each of weeks two to 12. Over the 12-week period, all subjects continue to be treated in accordance with the standard of care, which includes antibiotic treatment as appropriate. As of now, we have enrolled 32 patients in the study, which amounts to over 70% of the target enrollment. And are on track to report results at Week 13, evaluating healing of the wound associated with osteomyelitis in the first quarter of 2025. We then expect to report, a second readout in the first quarter of 2026, which is planned to evaluate amputation rates and resolution of osteomyelitis, based on X-ray, clinical assessment in established biomarkers such as ESR and CRP at week 52. With respect to cystic fibrosis, or CF program in the second quarter of 2024, we expect to hold a Type C meeting with the FDA, to discuss our clinical development plan for BX004. Assuming alignment with the FDA and the completion of our CMC work, we intend to submit a protocol, to all relevant regulatory authorities and following approval, begin patient enrollment in Phase 2b study. As already noted, we estimate releasing top line results from this study in the third quarter of 2025. And now, I'll pass it over to Avi to review our fourth quarter, and full year 2023 financial results.
Avi Gabay: Thank you, Jonathan. As a reminder, the financial information is available in the press release, we issued earlier today and also in more detail in our Form 10-K, which will be filed later today. I will walk you through some of our brief highlights. As of December 31, 2023, cash balance and short-term deposits were $15.9 million, compared to $34.3 million, as of December 31, 2022. The decrease was primarily to the net cash used in operating activities. In 2023, our R&D expenses net were $16.7 million, compared to $16.2 million in the previous year, mainly because of increased expenses, related to the CF clinical trial that was partially offset, by reduced salaries and related expenses and stock-based compensation expenses, as well as pausing in the development of the atopic dermatitis clinical trial. In addition, increased consideration from research collaboration, which resulted in reduced R&D expenses. General and administrative expenses, were $8.7 million for 2023, compared to $9.5 million for the prior year. The decrease was primarily due to a decrease in company's directors and officer insurance premium. Net loss for 2023 was $26.2 million, compared to $28.3 million for the prior year. Net cash used in operating activities for 2023, was $21.3 million, compared to $29.1 million for the same period in 2022. On March 15, 2024, we closed the acquisition of APT, concurrent with an investment of $15 million. Subsequent to this financing, we have fully repaid the remaining balance of approximately $10.4 million under the Hercules loan agreement. We would like to emphasize that although after the financing, we have sufficient cash, cash equivalent and short-term deposits, to fund our current operating plan for at least the next 12 months, our financial statements contain an explanatory paragraph, regarding substantial doubt about our ability, to continue as growing concern. This is mainly, due to the potential risk of our stockholders not approving the conversion of the convertible preferred stock that were issued, as part of the acquisition of APT and the concurrent investment. And now I'll turn the call back over to Jonathan, for his closing remarks. Jonathan?
Jonathan Solomon: Thank you, Avi. 2024 is shaping up to be a substantial year for BiomX with the completion of the APT acquisition and the $50 million investment from top institutional healthcare investors, our company is well positioned to build significant value for our stockholders as we continue advancing the BX004 and BX211 clinical programs. BX004 has already demonstrated safety and proof-of-concept efficacy, in our Phase 1b/2a study. We look forward, to reporting data on both BX004 and BX211 in 2025. We have also added additional scientific and business leadership, to our Board of Directors that will play an important role in helping guide our clinical development efforts, and interaction with regulatory authorities, while also helping us optimize our capital resources. Thank you again for joining us this morning, and we look forward to providing you, with updates throughout the year.
Operator: Thank you. [Operator Instructions] Our first question is coming from Joe Pantginis from H.C. Wainwright. Your line is now live.
Joe Pantginis: Hi, everybody. Good morning. Good afternoon. Thanks for taking the questions. So first, Jonathan, I just want to get the update since the merger, what is the - how is the process looking with regard to outstanding efficiencies and what might still be outstanding of note?
Jonathan Solomon: So good morning Joe. Great question. I think things are now moving. As we go through the process, we're often in Gaithersburg now, and we're quite impressed with the team and the work that APT is doing. Of course, this is a process that will take a while, and we're actively kind of evaluating redundancies. There will be some, and it will take us a while to kind of finalize all the specific plans going forward.
Joe Pantginis: Understood. And then if I could just - I appreciate all the added details you provided today on DFO. So - just to dive into the weeds a little bit. So one of the things I've been thinking, when you look at for DFO itself, to me, there's a lot of reminiscent characteristics of, say, critical limb ischemia. And one of the things, I guess, I would associate with that is, obviously, amputation rate is a key endpoint here, just like critical ischemia. And there are a lot of aggressive physicians out there to try to be - I'll almost go so far as to say cowboys, to try to prevent amputations where it might be necessary. So I guess the curiosity on my end is different aggressive physician techniques, or say maybe lack of standards, potentially, how does that impact what might be considered placebo impact, or placebo effect on this study?
Jonathan Solomon: So you're spot on it, I think amputation is a much more complicated endpoint, and I think that's what we look at as a more exploratory. We'll look at all to that. I think in this study, we're looking at a shorter time frame, and focusing - on the ulcer sort of potential shrinkage and maybe healing in some of these patients. I do agree that amputation is tougher. There is an ongoing research and body of work kind of trying to look into, the additional surrogate endpoints, so looking at the X-ray and some other endpoints. So that might give us a better sense of the healing process in the shorter time frame. There's also some KOLs, which are advocating, looking at even shorter time frame than the 12 weeks we're looking. So I think, we'll see all of that. Again, in this study, we're looking at a shorter time point, and way before kind of all of the amputations kick in. We'll obviously follow the patients for a longer period of time. We'll take all that information conversation with the FDA. But I agree. I think if we can, very reminiscent of I think, the discussions we had in CF, you can have and try to look at endpoints, which you could see something going on earlier, and hopefully with less patients, that's ideal because it is more difficult.
Joe Pantginis: Absolutely. I really appreciate the color Jonathan. Thanks.
Jonathan Solomon: You bet.
Operator: Thank you. Our next question today is coming from Michael Higgins from Ladenburg Thalmann. Your line is now live.
Unidentified Analyst: Good morning, guys. This is [Farhana] on behalf of Michael. Congrats again from us on the Adaptive acquisition deal. Two questions from us on BX004. Any feedback for us on any additional data analysis you have going on from the Phase 2 data? And if yes, when might we see that additional data?
Jonathan Solomon: So good morning. And thank you for the kind words. So far, we're not giving any guidance on anything new, we are considering presenting a few of the top conferences. So once we have it and get the acceptance, we will obviously update. I think the important activity that we're now gearing up to except for the preparation for the next clinical study, is obviously the meeting with the FDA. So that's something, we're expecting in the middle of the year that would be crucial. And again, as in before, we are working hand-in-hand with the CF Foundation, and this kind of represents probably the most advanced phage program. So I think, there's a lot of interest in the kind of feedback that, the FDA will give us.
Unidentified Analyst: All right. Great. Thank you.
Jonathan Solomon: You bet.
Operator: Thank you. We have reached the end of our question-and-answer session, I'd like to turn the floor back over to management for any further or closing comments.
Jonathan Solomon: So I just want to thank everyone for joining us this morning, and wishing you all a great day. And hopefully, we'll keep on updating you, as we make further progress. Thank you.
Operator: Thank you. That does conclude today's teleconference webcast. You may disconnect your lines at this time, and have a wonderful day. We thank you for your participation today.
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