Ethos Technologies Inc.

Good afternoon, ladies and gentlemen, and welcome to the 8th Tower Farmer fourth quarter and full year 2022 conference call. At this time, all participants are on a listen-only mode. Later, we'll conduct a question and answer session, and instructions will be given at that time. As a reminder, this conference call is being recorded for replay purposes. It is now my pleasure to hand the conference over to Ashley Dunstan, 8th Tower's Director of Investor Relations and Corporate Communications. Ms. Dunstan, you may begin.

Thank you, and good afternoon, everyone. Thank you for joining us today to discuss ATIRE's fourth quarter and full year 2022 operating results and corporate update. We are joined today by Dr. Sanjay Shukla, our president and CEO, and Ms. Jill Broadfoot, our CFO. On the call, Sanjay will provide an update on our corporate strategy, including our clinical program for EpsoCitimod and research and discovery programs. Jill will review the financial results and our current financial position before handing it back to Sanjay to open the call for any questions. Before we begin, I would like to remind everyone that except for statements of historical facts, the statements made by management and responses to questions on this conference call are forward-looking statements under the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those and such forward-looking statements. Please see the forward-looking statement disclaimer in the company's press release issued this afternoon as well as the risk factors in the company's SEC filings and included in our most recent annual report on Form 10-K, subsequently filed quarterly reports on Form 10-Q, and in our other SEC filings. Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made as facts and circumstances underlying these forward-looking statements may change. Except as required by law, Atire Pharma disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances. I will now turn the call over to Sanjay.

Thank you, Ashley. Good afternoon, everyone, and thank you for joining us for our fourth quarter and full year 2022 results conference call. At Atire, we're working to develop a new class of medicines from our tRNA synthetase biology platform with a current focus on disease areas related to inflammation and fibrosis with a high unmet medical need. Our lead therapeutic candidate, efsofitamide, is a novel immunomodulator that down-regulates innate immune responses in uncontrolled inflammatory disease states via selective modulation of Neuropilin 2, or NRP2. We're developing efsofitamide as a potential treatment for patients with interstitial lung disease, or ILD, a group of rare immune-mediated fibrotic lung disorders, with the goal of resolving inflammation to prevent the progression of fibrosis in order to improve outcomes for patients. 2022 was an important year for ATAR, as we advanced epizofitamide to a global pivotal Phase III study in patients with pulmonary sarcoidosis, the most prevalent form of IOD that affects nearly 200,000 people in the U.S. and more than 1.2 million worldwide. Despite current treatments and standard of care, which is primarily steroids, approximately half of patients will develop progressive disease and nearly one in five of all patients will develop lung fibrosis. There remains a need for safer and more effective treatments, including those that reduce steroid burden for patients. This phase three study, which is known as FSOFIT, is currently enrolling at multiple centers in the US, Europe, and Japan. We're pleased with the current pace of enrollment and we expect to provide additional details regarding the progress of this study in the future. Our strategy for Epsom Phenomod includes investigating the role this novel immunomodulator may play as a potential treatment for other more inflammatory forms of ILD. We announced last month that we are expanding the clinical development program for Epsom Phenomod to include a Phase II study in patients with ILD associated with systemic sclerosis, which is known as SSC, or more commonly, scleroderma. This is a major type of connective tissue disease that affects nearly 100,000 people in the U.S., with up to 80% of these patients developing ILD, which is the leading cause of death in these patients. We see SSC ILD as a logical second indication to explore For esophitimib, based on the clinical proof of concept demonstrated in pulmonary sarcoidosis patients and the translational effects seen in an animal model of SSC, where esophitimib was shown to reduce lung and skin fibrosis. Additionally, the path of pathology of SSCID is driven by the same immune cells that are central to pulmonary sarcoidosis pathology. And RP2 is upregulated on these cells and is also implicated in scleroderma. Furthermore, like sarcoidosis, standard of care is limited and current treatments are not disease-modifying and do not improve quality of life. We recently received clearance of an investigational new drug application by the US FDA for a Phase II study of esophitamide in patients with SSC-ILD, and we're planning to initiate this study later this year. This Phase II study is expected to be a randomized double-blind placebo-controlled proof-of-concept study to evaluate the efficacy, safety, and tolerability of F-sulfidamide in patients with SSCIOD. This is expected to be a 28-week study with three parallel cohorts randomized to either high or low dose F-sulfidamide or placebo, dosed intravenously monthly for a total of six doses. The study intends to enroll 25 patients with progressive disease who are currently receiving background mycophenolate therapy at multiple centers in the U.S. The primary objective of the study is to evaluate the efficacy of multiple doses of intravenous efsofitamide on pulmonary, cutaneous, and systemic manifestations in patients with SSC-ILD. We expect to provide additional details about the study once it begins. This program expansion increases the potential market opportunity for efsofitamide in these forms of ILD. Taken collectively, We believe there is a multi-billion dollar global market opportunity for efsofitamide in pulmonary sarcoidosis and SSCILD, and situates HR as the biotech leader in ILD. While our primary focus is our clinical program for efsofitamide, we continue to leverage our intellectual property estate, covering fragments from all 20 human tRNA synthetases, and utilize our platform as an engine to generate potential pipeline candidates and identify therapeutic targets. By leveraging the advanced technology made available to us through our research collaboration with Dual Systems Biotech, we have the opportunity to increase productivity in our discovery engine and efficiently generate new therapeutics from our tRNA synthetase domain library. As a reminder, in addition to Absofinamab, this platform has recently generated data characterizing the extracellular targets for two previously uncharacterized tRNA synthetase domains, which identified specific interactions with key targets involved in fibrosis. We're excited to advance pipeline candidates through the discovery phase and unlock the unique biology underlying these novel pathways while we work to complete our two clinical trials for efsofitamide. We also plan to actively explore ways to accelerate these discovery programs including through business development. I'll now turn it over to our Chief Financial Officer, Jill Broadfoot, to review our financial results.