BiomX Inc.

Greetings and welcome to the Biomics Inc. Third Quarter 2021 Financial Results. At this time, all participants are in a listen-only mode. A 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. I would now like to turn the conference over to your host, Ms. Marina Wilson, Senior Vice President of Finance for Biomics. Thank you. You may begin.

Thank you, and welcome to the Biomics Third Quarter 2021 Financial Results and Corporate Update Conference Call. The news release became available just after 6 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'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 to design, aim, expected timing, and interim and final results of our preclinical clinical trials and studies, including resumption of certain development programs, implications of changes in senior management, the sufficiency of our existing cash, cash equivalents, and short-term deposits to fund our operations until the end of 2023, the potential to receive up to $15 million in additional loan tranches if certain milestones are met, our pipeline and momentum, future shareholder returns, and the potential of our product candidates. 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 is noted earlier is on our website. Joining me on the call this morning are Jonathan Sellerman, our Chief Executive Officer, and Dr. Saleja Puttagunda, our Chief Medical Officer. With that, I will turn the call over to Jonathan.

Thank you, Marina, and good morning, everyone. In planning for the years ahead, Biomics has made the decision to prioritize the development of our cystic fibrosis and atopic dermatitis product candidates, as each has the potential to generate proof of concept clinical data lead-outs in 2022. Bionics will discontinue development of its acne program. We believe that by focusing on the efficient use of Bionics capital on selected programs that can generate clinically meaningful proof of concept data, we will best position our company to drive value creation for shareholders. With this decision, we will postpone our development efforts temporarily in inflammatory bowel disease and colorectal cancer and currently intend to resume development activities for IBD and CRC programs in 2023 assuming supported platform data. Importantly, our new strategic focus will have a positive impact on our balance sheet. This may allow us to extend our cash runway by up to six months until at least the end of 2023. In addition, tranches that may become available to us under a venture debt facility upon satisfaction of certain specified milestones can further extend our runway to the first half of 2024. We therefore believe that we remain well-positioned financially through our expected clinical data readouts in cystic fibrosis and atopic dermatitis. Let me now briefly review our cystic fibrosis, or CF, and atopic dermatitis, or AD, programs. Cystic fibrosis. BX004 is a phage-coctal candidate for the treatment of lung infections in cystic fibrosis patients. It is 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 CF. CF patients suffer from chronic infections and typically require prolonged and repeated courses of various antibiotics. Over time, the effectiveness of these therapies begin to diminish as multidrug-resistant bacteria strains appear. To address this significant unmet need, we have designer product candidate BX004 do not only be active against antibiotic resistant strains of pyragynosa, but to also penetrate biofilm and assemblage of surface associated microbial cells enclosing extracellular polymetric substance that is known to cause antibiotic resistance. In consultation with Cystis Fibrosis Therapeutic Development Network, Bionic plans to conduct a Phase 1 B2A trial comprised of two parts. Part 1, of the phase 1B2A trial will evaluate the safety, pharmacokinetic, microbiology, and clinical activity of BX004 with single ascending dose followed by multiple doses in eight CF patients that are confirmed to have chronic PR-GENOSA respiratory infections. We now anticipate results on the part one of this trial in Q2 of 2022. Part two of this trial will evaluate the safety and efficacy a BX004 treatment over 10 days in 24 CF subjects with chronic pyurgynosa respiratory infections, the same population as Part 1. Results in Part 2 of this trial are currently expected in Q3 2022. Now, let me turn to our program on atopic dermatitis. In October, we were pleased to announce an agreement with Maruhu for atopic dermatitis candidate BX005. As the leading dermatology-focused pharmaceutical company in Japan, Maru is an ideal partner to help us maximize the potential value of BX005 in Japan. The agreement provides Maru with the right of first offer to license BX005 in Japan, and this offer will commence following the availability of results from a proof-of-concept Phase 1-2 study, which is currently enrolling patients to evaluate the safety and efficacy of BX005. We were also pleased to announce that Maru made an equity investment in biomics of $3 million at a premium to the market share price, intended primarily to support the ongoing Phase I-II study. Given the depth of Maru's expertise in dermatology product development, we were pleased to enter this agreement, which provides external validation for a phage-directed approach in treating AD. As a reminder, Biomics Phage Cocktail BXO5 targets Staphylococcus aureus, or S. aureus, a bacterium implicated in the development and exacerbation of inflammation in atopic dermatitis. Staph aureus is known to be more abundant over 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 the patient experiences flares. With respect to the timing of the Phase 1-2 readout, due to a scheduling backlog from ongoing pandemic, we experienced a minor delay in meeting with the FDA to review this program. As a result, we now anticipate data third quarter of 2022. I'd like now to turn the call over to Marina Wolfson, our Senior Vice President of Finance and Operations, to cover our financial results for the third quarter of 2021. Thank you, Jonathan.