Q4 2022 Biomx Inc Earnings Call
Speaker 1: Good morning and welcome to the BioMix full year 2022 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 would now like to turn the call over to Marie.
Speaker 2: In a Wilson Chief Financial Officer of Biomix, please go ahead. Thank you and welcome to the Biomix 2022 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 on our website at Biomix.com.
Speaker 2: A replay of this call will be available on the Investors section of our website. Before we begin, I'd like to review the Safe Harbor Provision.
Speaker 2: All statements on this call that are not factual historic statements may be deemed forward to the King's statements.
Speaker 2: For instance, we're using forward-looking statements when we discuss on the conference call potential market opportunities, the design, aim, expected timing, and interim and final results of our preclinical and clinical trials, the sufficiency of our existing cash, cash equivalents, and short-term deposits.
Speaker 2: the potential to close on the second part of the pipe transaction, and the potential safety, efficacy, and other benefits of our product candidates.
Speaker 2: In addition, past preclinical and clinical results, as well as compassionate use, are not indicative and do not guarantee future success of our clinical trials.
Speaker 2: Except as required by law, we do not undertake to update forward-leaking statements.
Speaker 2: 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.
Speaker 2: Joining me on the call this morning is Jonathan Salomon, Chief Executive Officer of Biomics. With that, I will turn the call over to Jonathan.
Speaker 3: Thank you, Marina, and good morning, everyone. 2023 is shaping up to be a very exciting year for our company. Our Cystic Reversal Program with lead candidate BX004 continues to gain momentum based on the positive results announced back in late February in part one of our ongoing Phase 1 B2A study.
Speaker 3: Without question, this was a watershed moment for our company and for our technology. As these results demonstrated, an optimized phase cocktail product developed utilizing on both platforms, such as BX-004, could potentially reduce the presence of life-threatening bacteria in the lungs of CF patients after a short period of treatment.
Speaker 3: The part-run results also represented that first placebo controlled study is valuing a ocular-based phage product to show notable reductions in bacterial burden in cystic green surfaces patients.
Speaker 3: As a reminder, the X-A-B-L-O-IV is a phage cocktail that has been designed to combat chronic pulmonary infections caused by Toulin-Onesurginosis, or PSA, which is the main contributor to morbidity and mortality in sea appearance.
Speaker 3: Despite the availability of CFTR-directed therapies, the patients contain to suffer from intractable persistent infections, such as those caused by PR Genosa. Neutrument options are therefore needed to address a significant unmet need that impact thousands of CFP patients each year.
Speaker 3: Our ongoing Phase 1 B2A trial is comprised of two parts. Part 1 is valued at the safety pharmacokinetics and microbiological activity of BX004 in nine CF patients in a single ascending dose and multiple dose design.
Speaker 3: On February 22nd, we reported these exciting results and also held a conference call with the investors to review the data.
Speaker 3: For today's call, a plan on providing a high level of the view of the overall study result, however, a more detailed presentation on our data can be accessed on the Biomix website under our Industrial Relations News Event Sections.
Speaker 3: Our two of the trial will evaluate the safety and efficacy of BX-004 in a larger group of patients with 16 patients receiving Nebulized BX-004 therapy and 8 receiving placebo in the 2-1 randomization.
Speaker 3: Importantly, treatment duration will be extended over a 10-day period with twice-day early administration of the high dose versus the 7-day period of the escalating doses in part 1.
Speaker 3: We have already started those impatience in part two of the study and we remain on track to report results in the third quarter of this year.
Speaker 3: I'd now like to briefly recap the exciting results in part one of our CS study.
Speaker 3: The primary goal of Part 1 was to assess the safety and quality of BX-004.
Speaker 3: Baked therapies are generally considered safe, and that proved to be the case with BX-004 maintaining an excellent safety profile throughout the course of treatment.
Speaker 3: However, we're also highly encouraged to see preliminary evidence of the efficacy in patients treated with BX-004, despite the small sample size and short duration treatment during this first part of the trial.
Speaker 3: At day 15, patients treated with BX-104 had a mean reduction in PSA call reform units or CFUs compared to baseline of 1.42 log, while the mean reduction in PSA-CFUs was only 0.28 log for placebo treated patients.
Speaker 3: As noted on a cough of call last month, we're surprised by the magnitude of reduction in the kiloode, and these results exceeded our internal expectation, particularly considering the shorter-course of treatment of just seven days of escalating dose.
Speaker 3: Not surprising, the XLO formula obtained an external safety and tolerability profile would no treatment-related adverse effects observed in the study.
Speaker 3: Phase-based treatments are generally regarded as safe, and results from this study serve to reinforce this view, providing us with additional comfort that BX004 can be administered at higher dose and over a longer treatment period, as specified in part two of the CF study.
Speaker 3: Bage were detectable in several BX-004 treated patients up to day 15 or one week after the end of the seven day treatment period, and there's no emerging resistance to BX-004 during or after treatment.
Speaker 3: As expected, it was no change in lung function as measured by FEV-1, which we attribute to the shorter course of therapy specified in part 1 of the study. In summary, we believe BX-04 is emerging as one of the most promising development stage therapies for treatment of chronic BSA infections in patients with cystic fibrosis. In canvassing both the development stage landscape in the Compassionate Use program.
Speaker 3: The X-004 appears to be highly competitive with respect to a number of key product actuaries, including safety, tallability, and reducing pathogenic bacteria.
Speaker 3: In addition, we also believe Big 704 to be further differentiate from its potential to address resistance range of PSA given its unique design to confer orthogonal base coverage across packaging strains.
Speaker 3: I'd now like to turn the call over to Marina to review our financial results for the full year 2022.
Speaker 2: Thank you Jonathan.
Speaker 2: As a reminder, the financial information is available in the press release we issued earlier today, and also in more detail in our Form 10K, which will be filed later today. I will walk you through some of our brief highlights.
Speaker 2: As of December 31, 2022, cash dollars and short-term deposits were $34.3 million, compared to $63.1 million, as of December 31, 2021.
Speaker 2: The decreases primarily due to net cash use and operating activities.
Speaker 2: R&D expenses net were $16.2 million down from $22.7 million for the previous year, mainly because of reduced salaries, stock-based compensation, and workforce reduction, resulting from corporate restructuring.
Speaker 2: Additionally, the decrease was a result of discontinuing, pausing, and delaying the development of several programs.
Speaker 2: General and administrative expenses were $9.5 million for 2022 compared to $11.3 million for the prior year. The decrease was primarily due to a decrease in salaries and related expenses and stocked based compensation due to reduction in workforce.
Speaker 2: as well as a decrease in recruitment and employee related expenses, always resulting from corporate restructuring.
Speaker 2: Net loss for 2022 was $28.3 million compared to $36.2 million for the prior year.
Speaker 2: Netcash used in operating activities for 2022 was $29.1 million compared to $27.6 million for the same period in 2021.
Speaker 2: We estimate that existing cash, cash equivalent, and short-term deposits will be sufficient to fund the company's current operating plan through at least middle of 2024.
Speaker 2: And now I'll turn the call back over to Jonathan for his closing remarks. Jonathan?
Speaker 3: Thank you, Marina. As I mentioned at the beginning today's call, I believe Biomics was posed for an outstanding 2023.
Speaker 3: Despite continued challenges in the capital markets, we're well positioned based on potentially best-in-class BX-004 product candidates and CF, a strong balance sheet and support from current investors, including the CISIC-Frobersis Foundation.
Speaker 3: Immediately following the release of Part 1 data, biomephs was also able to raise additional capital from existing shareholders.
Speaker 3: We very much value and appreciate the support as the additional funds reflected grown optimism surrounding our GXLO 4 program.
Speaker 3: In our view, funding remains viable for those companies with product candidates that can demonstrate with BUS clinical data leading to best-in-class potential. We believe the X-104 clearly fits this profile. We couldn't be more pleased with the progress we can take to make and bring this potential you like-safing therapy to see if patients. We look forward to reporting our part two results in the third quarter of this year.
Speaker 3: Would that Marina and I would be happy to take any of your questions.
Speaker 3: Marina and I would be happy to take any of your questions. Operator?
Speaker 1: Thank you. We will now be conducting a question and answer session.
Speaker 1: If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation to indicate your lines in the question queue. You may press star 2 to remove yourself from the queue. Participants using speaker equipment may be necessary to pick up your handset before pressing the star keys. One moment please while we pull for your questions.
Speaker 1: Our first questions come from the line of Joe Pancinus with...
Speaker 1: Our first questions come from the line of Joe Pangenis with HC Wainwright. Please proceed with your questions.
Speaker 4: Hey there, Jonathan and Marina, thanks for taking the question. So first a quick question on the Part 1 data. Just curious, as we're moving into Part 2, will we be receiving any longer term follow-up from the Part 1 patients? Hi Joe, and good morning. There is a bit more...
Speaker 4: bit of nuance and impact of Part 1 on the Part 2 section of the study. So first, following the announcement of these data, is there any feedback you can provide as to impact on
Speaker 4: say part two enrollment kinetics and as well as any additional interest by new physicians for part two and do any of the physicians require any additional training or education to conduct part two relative to part one.
Speaker 3: So it's an excellent question. I mean, there is quite a lot of excitement sharing it with the PI's, you know, our supporters at the CF Foundation with the state I. So it's quite dramatic. As we said, right, we weren't expecting this level of bacteria reduction quality of the data that we've seen in part one.
Speaker 3: which is basically an initial safety study. So it definitely took us by surprise, a pleasant surprise that is. It is helping with communication. I think there's a lot more PIs that are excited, patients as well. I want to be conservative and I think we're keeping the same guidance.
Speaker 3: that we provide in the past, but things are definitely on track. A lot more incoming and also bear in mind that the part two is sort of not as intense on the patients. They're not required to come in every day. So there's definitely, we get the sense that there's more comfort and more excitement with participating in the part two.
Speaker 4: That's really helpful. And then maybe just one last checkbox question, if you don't mind, just making sure about the manufacturing status for 004 for not only part 2, but steps beyond.
Speaker 3: Yeah, so you know, it's a question we've spent some time talking right and I think it's still kind of paying dividends the decision we took two years to kind of put everything in house. So it's looking good. It's all under our control and you know, pretty straightforward. The cocktail sort of was optimized among other parameters for relative ease of manufacturing. So we do feel you know.
Speaker 3: very confident with supplies through the part two and now kind of starting to think about you know Pivotal studies and requirements. Yeah, the G&P requirement for Pivotal studies So that's something that work that we're now starting to do
Speaker 1: Got it. Thank you. That pleasure. Thank you. As a reminder, if you would like to ask a question, please press star one on your telephone keypad.
Speaker 5: Our next questions come from the line of Michael Higgins with Lattenberg-Thalmann. Please proceed with your questions. Good morning. This is Sahana on behalf of Michael. Congrats on the quarter. We have two questions. The first one relates to part two. I think Jonathan you had mentioned when the part one results came that they could provide some like could generate some changes to part two. So we were just wondering if any changes.
Speaker 3: earlier and a greater magnitude than one would expect. We're currently proceeding with Part 2 as planned. The team is thinking, consulting obviously with partner of the CF Foundation, KOLs, to think whether there's any additions, whether there's anything additional we can learn in Part 2. And I think once that's formal, if there's any updates, we'll provide them, but nothing so far.
Speaker 3: got a good handle on the part two and kind of thinking already about Pivotal study. After that, once that's solidified, we see where the market is. I think Ben will provide guidance on BXL03.
Speaker 5: Thank you.
Speaker 6: You bet. Pleasure.
Speaker 1: Thank you. There are no further questions at this time. I would now like to hand the call back over to Jonathan Solomon for any closing remarks.
Speaker 3: Sure, so everyone, thank you again for joining us this morning. We look forward to providing you future updates on our clinical programs here. Have a wonderful day and please feel free to reach out to us with any additional questions. Thanks again.
Speaker 1: Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.