BiomX Inc. (AMEX:PHGE) Q1 2023 Earnings Call Transcript

BiomX Inc. (AMEX:PHGE) Q1 2023 Earnings Call Transcript May 15, 2023

BiomX Inc. misses on earnings expectations. Reported EPS is $-0.27 EPS, expectations were $-0.2.

Operator: Good morning, and welcome to the BiomX First Quarter 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 would now like to turn the call over to Marina Wolfson, Chief Financial Officer of BiomX. Please proceed.

Marina Wolfson: Thank you, and welcome to the BiomX first quarter 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 on our website at biomx.com. 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. 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, 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, and the potential benefits of our product candidates.

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. 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: Thank you, Marina, and good morning, everyone. BiomX continues to make significant progress with the development of our lead product candidate, BX004 for the treatment of Pseudomonas aeruginosa or PsA, infections in patients with cystic fibrosis or CF. In February 2023, we announced positive results from Part 1 of our ongoing Phase 1b/2a trial. These results were better than we had anticipated, particularly with respect to the notable reductions observed in PsA bacterial burden. Enrollment in Part 2 continues to progress well and we expect to report results in the third quarter of 2023. As a reminder, in Part 2 of the study, we are dosing CF patients with BX004 twice a day at over a longer 10-day treatment period compared to Part 1.

Part 2 of the study is designed to provide additional data on safety and reduction in PsA bacteria burden along with other exploratory endpoints. As a reminder, PsA infections are highly pathogenic and represent a leading cause of loss of lung function in people with CF. After a few patients been infected with PsA, in his or her lungs, it is exceptionally difficult to fully eradicate the infection even with multiple courses of antibiotic treatment. PsA infections often persist over a period of several years. Unfortunately, treatment with antibiotics begins to wane over time. BX004 is a therapy designed to directly address the significant and unmet medical need in CF. I’m pleased to note that we had the opportunity to strengthen our balance sheet during this quarter after announcing Part 1 results.

On May 4th, we closed the second part of the private placement, which altogether raised total gross proceeds of approximately $7.5 million. We would like to thank our existing shareholders, which include OrbiMed and the Cystic Fibrosis Foundation, who led this financing. As a result of this funding together with our existing cash reserves, we expect that we’ll remain well funded through this time period, when we expect to announce Part 2 results. In addition to strengthening our balance sheet, we also had the opportunity to expand our Board of Directors. Last Friday, we announced the appointment of Jason M. Marks and Michael E. Dambach to the Board of Directors of BiomX. Jason most recently served as Executive VP, Chief Legal Compliance Officer and Corporate Secretary with Amarin Corporation; and Michael is Vice President and Treasurer of Biogen.

Both of these highly accomplished individuals bring in-depth corporate experience to our Board as seasoned executive leaders within the life science industry. As BiomX continues its plans to grow and expand the BX004 clinical program, Jason and Michael will undoubtedly bring invaluable perspective to help guide our decision-making on a wide range of financial, regulatory, and legal issues. I’d now like to turn the call over to Marina to review our financial results for the first quarter of 2023.

Marina Wolfson: Thank you, Jonathan. As a reminder, the financial information is available in the press release issued earlier today and also in more detail in our form 10-Q, which we expect to file later today. I’ll walk you through some of our brief highlights. As of March 31, 2023, cash balance and short-term deposits were $30.3 million compared to $34.3 million as of December 31, 2022. The decrease was primarily due to net cash using operating activities, partially offset by proceeds from the first closing of our PIPE financing. Research and development expenses net were $4.6 million for the three months ended March 31, 2023, compared to $4.9 million for the same period in 2022. The decrease was primarily due to reduced salaries and related expenses and stock-based compensation expenses resulting from a reduction in workforce, as part of the corporate restructuring we announced in May of 2022, as well as deprioritizing, pre-clinical and clinical activities related to our atopic dermatitis product candidate, BX005, partially offset by expenses related to conducting the Phase 1b/2a clinical trial of our CF product candidate, BX004.

General and administrative expenses were $1.6 million for the three months ended March 31, 2023 compared to $2.5 million for the same period in 2022. The decrease was primarily due to reduced salaries and related expenses and stock-based compensation expenses due to reduction in the workforce as part of the corporate restructuring, as well as the decrease in the Company’s directors’ and officers’ insurance premium. Net loss was $6.4 million for the first quarter of 2023 compared to $8.2 million for the same period in 2022. Net cash used in operating activities was $5 million for the three months ended March 31, 2023, compared to $7.4 million for the same period in 2022. We estimate that existing cash, cash equivalents and short-term deposits will be sufficient to fund the Company’s current operating plan into the third quarter of 2024.

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

Jonathan Solomon: Thank you, Marina. As we enter the second half of 2023, BiomX is well positioned to deliver on key clinical milestones in our BX004 program. We’re obviously encouraged by the results from Part 1 of the trial, which we believe could serve as a positive indicator for the results we hope to achieve in Part 2 of the trial. While great strides have been made over the last few decades to significantly increase life expectancies of CF patients, we also know that chronic and life-threatening infections remain the number one cause of morbidity and mortality in this patient population. Our BX004 program is squarely aimed at addressing the significant unmet medical need. And we look forward to expanding this program to help bring forward an important new treatment option for the CF community. With that, Marina and I would be happy to take your questions. Operator?

Q&A Session

Operator: [Operator Instructions] Our first questions come from the line of Joe Pantginis with H.C. Wainwright. Please proceed with your questions.

Operator: Thank you. Our next questions come from the line of Michael Higgins with Ladenburg Thalmann. Please proceed with your questions.

Operator: 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.

Jonathan Solomon: Thank you. So, I just wanted to thank you all for taking your time this morning and wish you all a good day and good luck to us all. Thank you.

Operator: 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.