BiomX Q4 2023 Earnings Call Transcript

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April 3, 2024

Key Takeaways

  • In Q4 2023 BioMx announced positive results from Part 2 of its Phase 1b/2a study of BX004, demonstrating safety and proof-of-concept efficacy.
  • In March 2024 BioMx completed the transformational acquisition of Adaptive Sage Therapeutics (APT), adding a second Phase 2 candidate, BX211, for diabetic foot osteomyelitis to its pipeline.
  • BioMx raised $50 million in a private placement led by affiliates of Deerfield Management and others, securing sufficient funding to reach multiple clinical milestones over the next two years.
  • The randomized Phase 2 study of BX211 in diabetic foot osteomyelitis has enrolled over 70% of the 45-patient target, with 13-week wound-healing data expected in Q1 2025 and 52-week amputation and resolution readouts in Q1 2026.
  • BioMx plans a Type C meeting with the FDA for its cystic fibrosis program BX004 in Q2 2024, aiming to initiate a Phase 2b study and report topline results in Q3 2025.
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Earnings Conference Call
BiomX Q4 2023
00:00 / 00:00

There are 5 speakers on the call.

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 Gebay, Interim Chief Financial Officer of Biomix. Avi, please proceed, sir.

Speaker 1

Thank you, and welcome to the Biomix full year 2023 financial results and corporate update conference call. The news release became available just after 6:30 am Eastern Time today and can be found in our website at www.biomics.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.

Speaker 1

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 issued and related matters in connection with the Adaptive Sage Therapeutics or APT acquisition potential market opportunities the ability to drive value for stockholders the design, aim, expected timing and interim and final results for 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 BX-two eleven. In addition, past and current preclinical and clinical results as well as compassionate cues 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.

Speaker 1

With that, I will turn the call over to Jonathan.

Speaker 2

Good morning, everyone. The Q4 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 1b2a 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 $50,000,000 in a private placement led by affiliates of Deerfield Management, AMR Active Fund with the participation of additional existing and new investors, including the Sysik Fibrosis Foundation, OrbiMaid and Nadenhala Capital. We deeply value and appreciate the support from these widely respected institutional investors.

Speaker 2

Including net proceeds from the financing and our existing capital, BioMarix now expects to have sufficient funding to reach multiple clinical milestones over the next 2 years, including expected data readouts for BX-two eleven and BX-four in the Q1 of 2025 Q3 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 FERS 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 2 clinical phage products, each having the potential to advance the standard of care in the respective disease area. As noted, the combined company has 2 significant Phase II 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.

Speaker 2

The study has already surpassed 70% of our target enrollment and we remain on track to report the week 13 treatment results in the Q1 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 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 lymph amputation.

Speaker 2

DFO standard of care often includes offloading of pressure from the foot to brighten surgery and up to a 6 week course of topical, oral or IV antibiotic therapy. Unfortunately, 30% to 40% of DFL cases failed 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.

Speaker 2

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 of the therapy to the infected bone. Biofilm, a polysaccharide mesh secreted by a 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 resistant 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 mesolin resistant staphylococcus aureus.

Speaker 2

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 break down biofilm. For example, phage were selected for the treatment of patients under our current DSO study were found when sequenced to supports phage risk therapeutic approach to improve treatment outcomes in DSO are the positive results from numerous compassionate cases using phage therapy. Out of 12 cases reported in the Saxon literature, 11 resulted in positive outcome of wound healing and avoiding amputation. PX-two eleven developed under APT's technology platform is based on personalized approach, which utilize one of the largest phage banks in the world to optimally pair individualized phage therapy to the specific strands of bacteria as biopsied from the patient.

Speaker 2

The treatment target 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 the arsenal of virulence factors. We estimate that BX211 represents a commercial opportunity of $1,000,000,000 in the U. S. And over $2,000,000,000 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 DSO associated with staph aureus.

Speaker 2

Approximately 45 subjects are planned to be randomized at a 2:one ratio to BX211 or placebo. BX211 or placebo is administered weekly by topical and IV route at week 1 and by the topical route only at each of weeks 2 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 Q1 of 2025. We then expect to report a second readout in the Q1 of 2026, which is planned to evaluate amputation rates and resolution of osteomyelitis based on X-ray clinical assessment and established biomarkers such as ESR and CRP at week 52.

Speaker 2

With respect to cystic fibrosis or CF program, in the Q2 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 Q3 2025. And now, I'll pass it over to Avi to review our Q4 and full year 2023 financial results.

Speaker 1

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 ks, 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 deposit were $15,900,000 compared to $34,300,000 as of December 31, 2022. The decrease was primarily to the net cash used in operating activities.

Speaker 1

In 2023, our R and D expenses net were $16,700,000 compared to $16,200,000 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 and D expenses. General and administrative expenses were $8,700,000 for 2023 compared to $9,500,000 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 $26,200,000 compared to $28,300,000 for the prior year.

Speaker 1

Net cash used in operating activities for 2023 was $21,300,000 compared to $29,100,000 for the same period in 2022. On March 15, 2024, we closed the acquisition of APT concurrent with an investment of $15,000,000 Subsequent to this financing, we have fully repaid the remaining balance of approximately $10,400,000 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 ongoing 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.

Speaker 1

And now, I'll turn the call back over to Jonathan for his closing remarks. Jonathan?

Speaker 2

Thank you, Avi. 2024 is shaping up to be a substantial year for BioMx. With the completion of the APT acquisition and the $50,000,000 investment from top institutional healthcare investors, our company is well positioned to build significant value for stockholders as we continue advancing the BX004 and BX211 clinical programs. BX-four has already demonstrated safety and proof of concept efficacy in our Phase 1b2a study. We look forward to reporting data on both BX-four and BX-two eleven in 2025.

Speaker 2

We have also added additional scientific 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

Our first question is coming from Joe Pantginis from H. C. Wainwright. Your line is now live.

Speaker 3

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?

Speaker 2

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.

Speaker 2

There will be some and it will take us a while to kind of finalize all the specific plans going forward.

Speaker 3

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 end point here just like critical limb ischemia.

Speaker 3

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?

Speaker 2

So you are 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 in a shorter timeframe and focusing on the ulcer potential shrinkage and maybe healing in some of these patients. I do agree that amputation is tougher.

Speaker 2

There is an ongoing research and body of work on trying to look into the additional surrogate endpoints as we're looking at the x-ray and some other endpoints. So that might give us a better sense of the healing process in a shorter timeframe. There's also some KOLs which are advocating looking at even shorter timeframe 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 the amputations kick in.

Speaker 2

We'll obviously follow the patients for a longer period of time. We'll take all that information in conversation with the FDA. 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.

Speaker 3

Absolutely. I really appreciate the color, Jonathan. Thanks.

Speaker 2

You bet.

Operator

Thank you. Next question today is coming from Michael Higgins from Ladenburg Thalmann. Your line is now live.

Speaker 4

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 PAS II data?

Speaker 4

And if yes, when might we see that additional data?

Speaker 2

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'll 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.

Speaker 2

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 stage program. So I think there's a lot of interest in the kind of feedback that the FDA will give us.

Speaker 4

All right, great. Thank you.

Speaker 2

You bet. Thank you. We've reached the

Operator

end of our question and answer session. I'd like to turn the floor back over to management for any further or closing comments.

Speaker 2

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 line at this time and have a wonderful day. We thank you for your participation today.

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