BiomX Inc.

Greetings and welcome to the Biomex second quarter 2021 financial results call. At this time, all participants are in a listen-only mode. The question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Marina Wolfson, Senior Vice President of Finance and Operations. Thank you. You may begin.

Thank you, and welcome to the Biomics second quarter 2021 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 biomics.com. A replay of this call will be available on the investors section of our website. Before we begin, I would 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're using forward-looking statements when we discuss potential market opportunities, the capabilities of the BOLT platform, the design, aim, expected timing, and interim and final results of our preclinical studies and clinical trials, the sufficiency of our existing cash, cash equivalents, and short-term deposits to fund the company's current operating plan until at least mid-2023, or with a full debt amount until the beginning of 2024, our cash runway, the potential for up to $15 million in additional loan trenches if certain milestones are met, and the potential of our product candidates. Except as required by law, we did 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 are Jonathan Salomon, our Chief Executive Officer, Dr. Salida Puttagunta, our Chief Medical Officer, and Asaf Oron, our Chief Business Officer. With that, I will turn the call over to Jonathan.

Thank you, Marina, and good morning, everyone. Let me start by saying how excited we are about the multiple catalysts the company will have in the next year. We are entering the most data-rich period in the company's history with expected readouts across all four of our clinical stage programs. In our view, any one of these readouts, if successful, could represent a transformative event for our company. This is all thanks to the hard work and dedication of our team. We also enter the second half of 2021 with more than sufficient capital to reach these important milestones. As previously announced, last month, Bionics completed a Registered Direct Offering of $50 million. Participation in this offering included both existing and new investors, and I was also gratified by the show of confidence from the Board of Directors, each of whom also participated in this offering. We further strengthened her balance sheet with access of up to $30 million of debt financing from Herkes Capital. a leader in customized debt financing for companies in the life science and technology related markets. The first $15 million tranche is available upon closing. Two subsequent tranches of $10 million and $5 million will become available upon the achievement of certain milestones. These two financing provide us with cash runway out to at least the middle of 2023 with a full debt supporting us until the beginning of 2024. Now, let me briefly summarize the progress we made to date in our four clinical programs that enable us to have potentially meaningful clinical readouts in up to four different indications through mid-2022. Starting with our acne program, top line results are on track to be reported for the eight and 12-week treatment periods in the third and fourth quarters of 2021, respectively. We are pleased to previously report that enrollment in the study was completed on May 13th, 2021. two weeks ahead of time. Given good progress, we can now confirm that the 12-week microbiologic assay analysis can be completed even earlier if bundled together with the 8-week samples. Therefore, we have made a decision to forgo the interim 8-week analysis, continue the blinded status of the study until completion, and conduct and report all analysis, 8-week and 12-week, together. Hence, The full study readout will be available end of October, only weeks after previously communicated timeline for the planned eight-week interim analysis, and in the earlier end of our prior guidance for the 12-week data. As a reminder, BX001 is a topical gel comprised of a cocktail of naturally occurring phage that targets the bacteria cutibacterium acne, or C. acne, which is implicated in the pathophysiology of acne vulgaris. The Phase II cosmetic clinical study is evaluating 140 subjects with mild to moderate acne vulgaris. Key endpoints of the study include safety, tolerability of BX001, in addition to its impact on the appearance of an acne-prone skin. We will evaluate BX001 for cosmetically meaningful improvement of acne-prone skin, as well as a reduction of C acne burden. We look forward to reporting on these results in the upcoming months. With respect to our Cystic Fibrosis Program, BX004 is our phage-coctor candidate designed to target Pseudomonas arginosa, or P. arginosa, a bacteria that causes chronic respiratory infection and is a main contributor to morbidity and mortality in patients with cystic fibrosis, CF. By way of background, CF patients suffer from chronic lung infections and typically require prolonged and repeated courses of various antibiotics, whose effectiveness diminishes over time as multidrug-resistant strains appear. BX004 has the potential to be both active against antibiotic-resistant strain of Pseudomonas aeruginosa and to penetrate biofilm. An assemblage of surface-associated microbial cells enclose an extracellular polymetric substance and one of the leading drivers of antibiotic resistance. In consultation with Cystic Fibrosis Therapeutic Development Network, Biomics will be conducting a Phase 1 B2A trial, compromised of two parts. Part 1 will evaluate the safety, pharmacokinetic, microbiologic, and clinical activity of BX004 in a single ascending dose fashion, followed by multiple doses in 8 CF patients. that are confirmed to have chronic pseudomonas arginosa respiratory infections. Results in Part 1 of this trial are expected to be in the first quarter of 2022. Part 2 of this trial will evaluate the safety and efficacy of BX004 treatment over 10 days in different cohort of 24 CF subjects with chronic pseudomonas arginosa respiratory infection. As in Part 1, results in Part 2 of this trial are expected by the second quarter of 2022. Returning to our atopic dermatitis program, our phage cocktail, BX005, is designed to target staphylococcus aureus, or S. aureus, a bacterium associated with the development and exacerbation of inflammation in atopic dermatitis. S. aureus is known to be more abundant in the lesional skin of atopic dermatitis patients compared to the skin of healthy individuals or non-lesional skin of atopic dermatitis patients. The target bacteria also increases in abundance and becomes dominant when patients experience flares. We expect results from a Phase 1 B2A proof-of-concept clinical study evaluating the safety and efficacy of BX005 in the first half of 2022. During the second half of 2021, we plan to advance our clinical program in inflammatory bowel disease and primary sclerosis and cholangitis into a Phase 1 B2A trial of BX003. Study arms will include either healthy subjects or IBD or PUC subjects or confirmed carriers of the target bacteria, Klebsiella pneumoniae, in their gut. The Phase 1b2a is a four-week placebo-controlled dosing study designed to evaluate the safety, tolerability, and efficacy of BX003 as measured by the reduction of the amount of target bacteria in stool. Results are expected in the second quarter of 2022. Finally, Let me briefly touch on our preclinical immuno-oncology program focused on colorectal cancer, or CRC. Despite the success of immunotherapy in cancer, only a small percentage of new cases of CRC respond to immunotherapy. This limited response is believed to be due to the lack of novel tumor antigens and scarcity of immune cells in colorectal tumors. We have observed in vitro and in vivo that phage can be used to target strain of Fusobacterium nucleatum, FN, a bacterial species that is highly enriched in colorectal tumors and is believed to contribute to the pathogenesis. We plan to administer phage with target F-nucleatum intravenously to deliver payload genes, such as those encoding immune-stimulator proteins to tumors, while also reducing bacterial load of these bacteria. We have successfully engineered an IL-15 gene payload into F-nucleotide and phage, and we plan to announce our preclinical results in this program in the fourth quarter of 2021. We look forward to keeping you informed on our progress. I'd like now to turn the call over to Marina Wolfson, our Senior Vice President of Finance and Operations, to review our financial results for the second quarter of 2021. Thank you, Jonathan.