BiomX Q1 2024 Earnings Call Transcript

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Provided by Quartr
May 21, 2024

There are 6 speakers on the call.

Operator

Hello, and welcome to

Speaker 1

the Biomix First Quarter 20 24 Financial Results. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to CFO, Avi Gabai. Please go ahead, Avi.

Speaker 2

Thank you, and welcome to the Biomik's Q1 2024 financial results and corporate update conference call. The press release became available just after 6:30 am Eastern Time today and can be found on our website at www.biomex.com. A replay of this call will also be available on the Investors section of our web site. Before we begin, I'd like to review the Safe Harbor provision. All statements on this call that are not factual historical statements may be deemed forward looking statements.

Speaker 2

For instance, we are using forward looking statements when we discuss on the conference call the sufficiency of the combined financing, potential stockholder approval of certain matters related to the securities issued and related matters in connection with the Adaptive Faith Therapeutics or APT merger, potential market opportunities, the ability to drive value for stockholders, the design, recruitment, aim, expected timing and interim and final results of our preclinical and clinical trial, the regulatory process and discussion with the FDA, potential benefits and commercial opportunities of our product candidate and the potential safety and efficacy of BX004 and BX-two eleven. 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 Vionix.

Speaker 2

With that, I'll turn the call over to Jonathan.

Speaker 3

Good morning, everyone. For the first time, Biomix is reporting results for a combined entity following our merger with APT in March, and Avi will elaborate more on this. Overall, the Q1 of 2024 was nothing less than transformational for BioMx. The company has now entered into a new era. With the merger with APT in March, we have expanded our mid clinical stage programs, which we With the recent merger, we've added a second Phase 2 product candidate, With the recent merger, we've added a second Phase 2 product candidate, BX211, for the treatment of diabetic foot osteomyelitis or DSO.

Speaker 3

And I'll review our progress shortly. BX004, our most advanced mid clinical stage candidate, has already shown what we believe are promising clinical supporting the potential of Phase therapy to treat harmful bacteria underlying serious chronic infections in cystic fibrosis or CF patients. The broadening of our pipeline, the diversity of our approaches and the data we've seen to date are all key in reducing risk inherent in biotech developments. Concurrently with the merger with APT, we raised $50,000,000 of gross proceeds in a private placement led by affiliates of Deerfield Management and the AMR Fund with the participation of additional existing and new investors, including the cystic fibrosis foundation, OrbiMed and Nathan Hala Capital Management. These important and accredited life sciences investors provide further validation for the potential of Phase therapy as a new therapeutic modality and the strength of our lead candidates, each having the potential to advance the standard of care in their prospective disease area.

Speaker 3

Including net proceeds from financing and our existing capital, BioMx now expect to have sufficient funding to reach multiple important clinical milestones through 2025, including expected data readouts for our lead candidates BX-two eleven and BX-four in the Q1 of 2025 and the Q3 of 2025 respectively. We believe these Phase 2 data readouts could potentially drive significant value for our stockholders. We are thrilled with the continuing progress of both of our Phase 2 programs. On our last earnings calls, I had the opportunity to take a deep dive into BX-two 11 as part of the merger with APT. As a reminder, BX-two eleven is a personalized fate treatment being evaluated in the randomized, double blinded placebo controlled multicenter Phase 2 trial for subjects with DSO associated with staphylococcus aureus.

Speaker 3

This is an area of high unmet need. Each year, there is a staggering number of approximately 160,000 lower limb amputation in diabetic patients in the U. S. Alone, 85% of which are caused by DSO according to the Centers For Disease Control and the Literature. We believe that phage based therapeutic approaches have the potential to greatly improve treatment outcomes in DFO.

Speaker 3

Reports in the scientific literature compassionate use with phage therapy have shown that 11 of 12 cases resulted in positive outcomes of wound healing and avoiding amputation. Finding from these cases played an important role in the design of the ongoing Phase 2 of BX-two eleven. With the target enrollment of 45 patients, the trial has already surpassed 70% of this target and we remain on track to report on the week 13 treatment results in the Q1 of 2025. We are also excited by the progress of BX004, our other lead mid clinical stage candidates. BX004 is a fixed multi phase cocktail for the treatment of CF patients with chronic pulmonary infections caused by Pseudomonas aeruginosa, a main contributor to the mobility and mortality in these patients.

Speaker 3

In January this year, we were granted orphan drug designation by the FDA for and efficacy results from Part 2 of our Phase 1b2a trial of BX004 at the European Society of Clinical Microbiology and Infectious Disease, or ESCMID, Global Congress. In fact, our presentation was selected as the top poster, ranking it among the top first, second percentile of top rated abstracts and the category submitted and accepted at the Congress. We believe that the data for BX004 are the most promising advanced findings published to date for phage therapy for the treatment of chronic pulmonary infections in CF patients. We've shown with BX004 both conversion to sputum culture negative psutumab silginosa in 14.3% of patients and demonstrated signals of improved pulmonary function after only 10 days of treatment. Both findings in contrast to results in placebo.

Speaker 3

Under a Phase 2b trial, we now plan to treat for a much longer treatment duration of 2 months, which we believe has the potential to demonstrate a more pronounced effect on both, microbiological and lung functional readouts. As previously reported, by mid-twenty 24, we anticipate holding a Type C meeting with the FDA to discuss our clinical development plans for BX004. Pending alignment with the FDA and completion of the remaining CMC work, our plan is to submit a Phase 2b study protocol to all relevant regulatory authorities and initiate the study by the end of this year. As already noted, we estimate releasing top line results on study in the Q3 of 2025. We are thrilled to have what we believe is the broadest and most advanced phage pipeline with promising data already reported and key readouts in Phase 2 studies in both our lead programs in 2025.

Speaker 3

On this final note, I'll now pass it over to Avi to review our Q1 2024 financial results. Avi?

Speaker 2

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 Q that was filed yesterday. I will walk you through some of our brief highlights. As of March 31, 2024, cash balance and short term deposit were $44,100,000 compared to $30,300,000 as of March 31, 2023. The increase was primarily due to the private placement, which was partially offset by net cash using operating activities and the repayment of the debt facility in March 2024.

Speaker 2

The company estimates its cash, cash equivalent and short term deposits are sufficient to fund its operations throughout the Q4 of 2025. In the Q1 of 2024, research and development expenses net totaled $4,100,000 compared to $4,600,000 in the Q1 of 2023, mainly because of less expenses due to the end of the CF clinical trial and was partially offset by lower grants payment from the Israeli Innovation Authority and R and D expenses related to the APT that were incurred after the merger. General and administrative expenses were $2,700,000 for the Q1 of 2024 compared to $1,600,000 for the same period in 2023. The increase was primarily due to expenses related to the merger with APT and the concurrent private placement. Net loss for the Q1 of 2024 was $17,300,000 compared to $6,400,000 for the Q1 of 2023.

Speaker 2

The increase is mainly due to change to fair value of private placement warrants that were issued in this quarter. Net cash used in operating activity for the Q1 of 2024 was $11,400,000 compared to $5,000,000 for the same period in 2023. On March 15, 2024, we closed the merger with APT concurred with an investment of $15,000,000 We would like to emphasize that although after the financing, we believe we will have sufficient cash, cash equivalent and short term deposit to fund our current operating plan at least 12 months, our financial statements contain an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern. This is mainly due to the potential risk of our stockholders not approving the conversion of the convertible preferred stock that was issued as part of the merger with APT and the concurrent investment. And now, I'll turn the call back over to John Sand for his closing remarks.

Speaker 2

Jonathan?

Speaker 3

We've accomplished a lot so far in 2024 and we're looking forward to the continuing substantial momentum at Biomx this year and into 2025. With recent development, Biomex has set itself apart as a leader in developing phage based therapeutics. The merger and $50,000,000 investment from top institutional healthcare investors allowed us to expand our pipeline and have positioned us to achieve key data readouts next year. By advancing our BX004 and BX211 clinical programs, our company is poised to build significant value for our stockholders. As at the recent ESC and ID Congress, our team will continue to seek important opportunities to present in peer reviewed forms.

Speaker 3

Based on the recent financing, we believe the company has sufficient cash runway to reach additional important clinical milestones as we advance our phage candidates addressing serious chronic infections. Indeed, it is a new era for Bionix.

Speaker 1

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

Speaker 4

Hey, guys. Good morning. Good afternoon. Thanks for taking the question. So two questions, Jonathan.

Speaker 4

First, for the upcoming Phase IIb in CF, I was just curious, I mean, even since your year end call or what have you, have you been talking to additional physicians in KOLs, has there been any additional evolution in your thinking about the design of the study, inclusion criteria, etcetera, going into your Type C meeting? And then the second question is, efforts going with regard to the varying manufacturing facility? Thanks a lot.

Speaker 3

Good morning, Joe, and thanks for the great questions as always. So first on the CF study, so we spent quite a lot of time analyzing the data and working hand in hand with the CF Foundation. So I think we have a good handle on the design of the Phase 2b, trying to address some of the questions that we've discussed and trying obviously to increase the percentage of patients that experience conversion and get even clear signals on both microbiology as well as clinical endpoint. So I think that has matured. Again, I think we're waiting for the FDA meeting and we'll see kind of where the feedback is.

Speaker 3

If all is according to plan, then I think we're locked and loaded to initiate the study at the end of the year. So, so far, I think, again, there was a lot of work upfront. So I think we feel good about it. The integration, so now in sunny BC, by the way, the weather is gorgeous. And it's definitely not a simple task to integrate these 2 companies.

Speaker 3

But I think as time goes, the rationale kind of plays out, right? So I do think it plays into APT strength in terms of the manufacturing capability, the access to the compassionate cases, the knowledge, access to governmental agencies. So I think all those are strength that quite frankly Biomix lacked. So I think it's proceeding well like every integration, it's not simple. But there's been a lot of effort.

Speaker 3

The teams have been traveling quite extensively. And now I think we feel that the situation is stabilized and there's very clear work plans, budgets approved and we're ready to go. So crossing our fingers to continue the momentum and again generate more value.

Speaker 4

Appreciate the comments. Thanks, Jonathan.

Speaker 3

Pleasure as always.

Speaker 1

Thank you. Next question is coming from Yale Jen from Leibold and Company. Your line is now live.

Operator

Good afternoon and thanks for taking the questions and congratulations, Jonathan. I've got two questions here. First one just follow-up with Joe's question, which is that in terms of the Phase 2 study you're proposing, would that be potentially adding a very extension part after the trial was done, so patient can get a longer treatment? And that's one. And then I have a follow-up.

Speaker 3

Okay. So I think the Phase 2 is already quite a long duration, right? We're going for 2 months and we'll follow-up the patients and think about whether we extend if we're seeing conversion. So I think these are items that we're discussing. I think a lot depends on feedback from FDA.

Speaker 3

There will be a longer follow-up for sure. I do think there is a chance to also explore extending it. Definitely, I think we'll want to extend to some extent in the patients that experience conversion kind of see how long can we keep the bug at bay, right. So I think that would be very dramatic. So it's definitely one of the items that we're discussing.

Speaker 3

And Yale, I believe you had another question.

Operator

Yes, I do. And this is a little bit more fundamental questions here. As we know that the virus I'm sorry, the phage has lytic and the lysogenic phase. So how would you ensure all your product retain us in the lytic state and that will be the most that is the functional state of the phage for killing the bacteria? And thanks.

Speaker 3

Yes, yes, it's a good question. And viruses are phage are viruses, right? So I do think it's a valid analogy. By the way, the big conference is like viruses and microbes, the phage conference. I think to your point, the FDA has been very clear on not wanting to advance forward phage, which are lysogenic, right.

Speaker 3

And the way to address it is actually by making sure that all the phage that we deploy, whether in the personalized approach such as the DFO study or in the cocktail, actually don't have any lysogeny genes. So we sequence everything. Again, these are quite a few genes. So it's not that a spontaneous single mutation will introduce life altering, right. It's not that we knocked off life altering with a single mutation.

Speaker 3

There's no life altering genes whatsoever. So the probability of a phage kind of acquiring or developing Loxantin gene is measurable. So that's the approach again sequencing, making sure that the phase don't have those capabilities and it's all part of the battery of tests, such as generalized transaction and other attributes that the FDA has been very clear on what kind of characteristic and what they want to see and what characteristics they don't want to see in a phased product undergoing development.

Operator

Okay, great. That's very helpful for investors. And again, congrats on all the progress and look forward to talking to you guys there.

Speaker 3

Thanks, Yale, for the kind words.

Speaker 1

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

Speaker 5

Hi, guys. Good morning. This is Farhana on behalf of Michael. Congrats on your continued progress. Two questions from us.

Speaker 5

The first on BX004. Could you confirm with us that aligning with the EMA is also in 2024? And the second question is on BX 211, any gating factors to completing enrollment in the Phase 2 DFO study?

Speaker 3

Good morning and good questions. Just to make sure regarding the first question, you mean like the European compliance of the VX004?

Speaker 1

Yes.

Speaker 3

Got it. Okay. So all good question. Again, VX004 going after CF, orphan indication, But

Speaker 1

that

Speaker 3

already was a global study, right? So already in the Part 2, But that already was a global study, right. So already in the Part 2 of the Phase 2a, we had U. S. Sites, European sites as well as Israeli sites.

Speaker 3

So that's going to continue. I think we're looking at much more sites in the second study of the Phase 2b. Definitely, Europe is going to be key. I think there's we've experienced, I think, very good recruitment in the U. S.

Speaker 3

And we'll definitely continue that. So that's in the works and part of the work plan and the timelines that we've presented. BX-two eleven, so enrollment is going well. As reported this morning, 70% of patients have been enrolled. Again, I think these studies are not trivial.

Speaker 3

It's a complex indication. We want to verify that the patients have the bacteria. We're deploying the phage banks. So that means that we ship basically phage to our sites. We optimize the best phage for that patient and we ship it back and that's the treatment that the patient gets.

Speaker 3

So we have seen challenges. Again, there's a lot of experience in the system by now with these studies. So I think we've learned a lot. We will put some effort even to try to if we can improve recruitment rates. But so far, it's going well and it's meeting our expectations.

Speaker 3

But we know clinical studies are always difficult. So let's just hope it continues the way it has.

Speaker 5

Okay. Thank you.

Speaker 1

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

Speaker 3

Thank you again everyone for joining us this morning. We look forward to providing you with updates throughout the year and have a great day. Thank you.

Speaker 1

Thank you. That does conclude today's teleconference and 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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Key Takeaways

  • Following the March merger with APT, BioMx now reports a combined entity with an expanded pipeline that includes a second Phase 2 candidate, BX211, for diabetic foot osteomyelitis.
  • In a concurrent private placement, the company raised $50 million from Deerfield, AMR Fund, Cystic Fibrosis Foundation and others, providing funding to reach key clinical milestones through Q4 2025.
  • The ongoing Phase 2 trial of BX211 has surpassed 70% of its 45-patient target in diabetic foot osteomyelitis and remains on track to report week 13 results in Q1 2025.
  • BX004, granted Orphan Drug designation for CF, showed a 14.3% sputum culture conversion and improved lung function in Phase 1b/2a, and the company plans a Phase 2b study by year-end with topline data expected in Q3 2025.
  • At March 31, cash and short-term deposits totaled $44.1 million, giving a runway into Q4 2025, though a “going concern” note remains pending stockholder approval for certain securities issued in the merger.
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Earnings Conference Call
BiomX Q1 2024
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