Ethos Technologies Inc.

Ladies and gentlemen, this is your operator speaking. Today's conference is scheduled to begin momentarily. Until that time, your lines will again be placed on hold. Again, ladies and gentlemen, this is your operator speaking. Today's conference is scheduled to begin momentarily. Until that time, your lines will again be placed on hold. Thank you for your patience. Thank you. Thank you. Good afternoon, ladies and gentlemen, and welcome to the Atire Pharma first quarter 2021 conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session and instructions will be given at that time. As a reminder, this conference is being recorded for replay purposes. It is now my pleasure to hand the conference call over to Ashley Dunston, Atire's Director of Investor Relations and Corporate Communications. Ms. Benson, you may begin.

Thank you, operator, and good afternoon, everyone. Thank you for joining us today to discuss ATIR's first quarter 2021 operating results and corporate update. We are joined today by Dr. Sanjay Shukla, our president and CEO, Ms. Jill Broadfoot, our CFO, and Dr. Leslie Nangle, vice president of research. On the call, Sanjay will provide an update on our corporate strategy, including our clinical program for ATYR 1923. Leslie will provide an update on our research and discovery programs in NeuroPillin 2, including our preclinical program for ATYR 2810 and our bispecific antibody program with our subsidiary, Pangu Biopharma. Jill will review the financial results and our current financial positioning before handing it back to Sanjay to open the call-up 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 in 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 and quarterly reports on Form 10-Q. 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, ATAR 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 first quarter 2021 results conference call. 2021 is shaping up to be an impactful year for the company. During the first quarter, we made meaningful progress with our clinical, preclinical, and research and discovery programs. We remain focused on advancing our lead therapeutic candidate, APYR 1923 or 1923. With enrollment completed in our Phase 1b-2a clinical trial in pulmonary sarcoidosis, our initial interstitial lung disease or ILB indication, we are tracking towards readout from this important proof of concept study. Having gained key mechanistic insights regarding 1923 anti-inflammatory effects in patients from data obtained from our Phase 2 clinical trial in COVID-19 severe respiratory complications, we look forward to the following second dose, expected in the third quarter of this year. Furthermore, we generated additional preclinical data for ATYR2810, or 2810, our anti-neurofilin 2, or NRP2 antibody, in preclinical development for cancer. As we begin, I'll summarize a few additional highlights since we last spoke in March. We appointed leading sarcoidosis advocate Andrea Wilson, co-founder and former president and member of the board of directors of the Foundation for Sarcoidosis Research, or FSR, as patient advisor to the company. In collaboration with the FSR, we participated in a virtual town hall on steroids and sarcoidosis to discuss the burden of steroid treatment and the need for new therapeutic options. We presented two posters at the annual meeting of the American Association for Cancer Research on preclinical data for 2810 in models of triple negative breast cancer and non-small cell lung cancer. We entered into an agreement with Lonza, a leading contract development and manufacturing organization, for the manufacture of 2810 to support the progression of 2810 to clinical stage development. Pengu Biopharma, or Pengu, our Hong Kong subsidiary, together with the Hong Kong University of Science and Technology, achieved the milestones for the first year of a two-year project funded in part by a grant from the Hong Kong government's Innovation and Technology Commission to develop a high-throughput platform for the development of bi-specific antibiotics targeting ARP2. And finally, we promoted Dr. Leslie Nangle to Vice President of Research. Dr. Nangle will serve as a member of our executive leadership team, managing research and scientific operations. We're highly encouraged by what we've accomplished this year thus far, and look forward to building on over 200 programs and discovery pipelines from our novel biology platform as we move forward this year. Let's begin with our clinical program for 1923. We're developing 1923 as a potential treatment for severe inflammatory lung disease. 1923 is a potential first-in-class immunomodulator that down-regulates avarice immune responses in inflammatory disease cases. 1923 has been shown preclinically to down-regulate inflammatory cytokines and reduce inflammation and fibrosis. NRP2 is up-regulated on key immune cells known to play a role in inflammation and is enriched in inflamed lung tissue. 1923 binds selectively to NRP2 and therefore has the potential to normalize the immune system, serving to resolve inflammation and prevent progressive fibrosis, thereby stabilizing lung function and alleviating morbidity and mortality. Our lead program is focused on ILD, a group of rare immune-mediated disorders that cause progressive fibrosis of the lung. Our initial ILD indication is pulmonary sarcoidosis, the most inflammatory form of ILV, which is characterized by the formation of granulomas or clumps of immune cells in the lungs. If left untreated, it can lead to irreversible scarring and diminish lung function. Current treatment options are limited and often include treating the inflammation with corticosteroids and other immunosuppressive therapies, which have limited efficacy and serious long-term toxicity. Additionally, many patients do not respond to this current standard of care. There remains a need for a novel treatment option for patients with progressive disease with a better efficacy and side effect profile. We recently spent some time deepening our understanding of the need for new treatment options for patients with sarcoidosis, including alternatives to steroids, and we've made a concerted effort to better recognize the needs of the community. As part of these efforts, we appointed Andrea Wilson, Sarkidos' patient and advocate, as an advisor to the company. Andrea has dedicated the past 20 years to promoting awareness and generating support to accelerate research to find a cure for this disease. She co-founded the NSR, the leading international nonprofit organization dedicated to finding a cure and improving care for Sarkidos' patients, and previously served as president and a member of its board of directors. So firsthand knowledge of the patient combined with our longstanding advocacy experience in relationship with the sarcoidosis community will help support patient strategies for advancing our 1923 clinical program in pulmonary sarcoidosis. And we look forward to our contributions in the future. Additionally, April was Sarcoidosis Awareness Month. And as part of our efforts to bring attention to this chronic debilitating disease, we were invited by the FSR to participate in a virtual town hall on steroids and sarcoidosis to discuss treatment options and strategies for patients living with sarcoidosis. I was honored to join this panel, which included two sarcoidosis patients and a leading pulmonologist. This panel provided a real-world and firsthand perspective, highlighting the toxic effects of steroids and shedding a light on the need for better and more effective treatments. The majority of sarcoidosis patients will receive steroids at some point during the course of treatment. Corticosteroids are highly associated with obesity, malaise, decreased bone density, cataracts, hyperglycemia, and edema. Nearly each of these side effects on their own are a condition to treat and manage. Currently used steroid sparing agents, such as cytotoxic immunosuppressants, have limited clinical evidence supporting their use in sarcoidosis. and are associated with significant side effects such as infection, liver toxicity, and even malignancies. We believe that patients deserve better. 1923 presents a potential option to do better. In clinical studies today, 1923 has shown a favorable safety profile. This includes data from a Phase I study in healthy volunteers, a Phase II study in patients with COVID-19-related severe respiratory complications, and two independent data safety monitoring board reviews from the ongoing Phase 1b-2a study in pulmonary sarcoidosis. In each of these studies, 1923 was assessed to be generally safe and well-tolerated with no drug-related serious adverse events. Based on recent proof of mechanism and its favorable safety profile, 1923 could be a transformative alternative to steroids and other available treatments with improved patient outcomes. As a reminder, our ongoing trial in pulmonary sarcoidosis is a Phase 1b, 2a, randomized, double-blind, placebo-controlled, multiple ascending dose clinical trial in 37 pulmonary sarcoidosis patients. This trial consists of three cohorts testing doses of one, three, and five milligrams per kilogram of 1923 for a placebo, dose intravenously every month for six months. The primary objective of this study is to evaluate the safety and tolerability of multiple ascending doses of 1923. Secondary objectives include the assessment of potential steroid sparing effects of 1923. In addition to other exploratory assessments of efficacy, such as lung imaging, lung function assessed by pulmonary function tests, and relevant serum biomarkers. Based on our trial design, an integral element of the study is to assess steroid burden in the 1923 treatment groups compared to placebo. As we have discussed here a bit today, Due to the side effects and toxicity of currently available treatments, there is a crucial need for alternatives to existing treatment options, including steroids. We look forward to the results of this study, which we expect to report in the third quarter of this year. I'd like to now turn the call over to Dr. Leslie Emanuel, VP of Research. As I mentioned, we recently promoted Leslie to the company's executive leadership team to manage research and scientific operations. Leslie has dedicated her career to tRNA synthetase biology and the pathways they regulate, having studied under Dr. Paul Schimmel, ATAR's co-founder, and having served in scientific research roles at ATAR since joining the company in 2007. We're very pleased to have her with us today to review recent updates from our research pipeline, starting with our NRP2 antibody program.