Ethos Technologies Inc.

Good afternoon, ladies and gentlemen, and welcome to the A Tire Pharma third quarter 2022 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, A Tire's Director of Investor Relations and Corporate Communications. Ms. Dunston, you may begin.

Thank you, and good afternoon, everyone. Thank you for joining us today to discuss ATAR's third quarter 2022 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, our VP of research. On the call, Sanjay will provide an update on our corporate strategy, including our clinical program for Epsofitimod and research and discovery programs. Jill will review the financial results and our current financial position before handing it back to Sanjay to open up 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 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, including 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, ATAR Pharma disclaims any obligations 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 third quarter 2022 results conference call. The third quarter saw the initiation of EPSO-FIT, a global pivotal phase three study of our lead therapeutic candidate, Epsofitamod, in patients with pulmonary sarcoidosis the most prevalent form of interstitial lung disease, or ILD. We dosed the first patient in this study in September, meeting aggressive timelines and guidance. Amid current market conditions, we intend to focus our resources on prioritizing EpsoFit, which is our highest value program to ensure a timely and successful completion of this study. As we begin, I will summarize a few additional highlights since we last spoke in August. We announced the publication of results from the Phase 1b-2a study of efsofitamide in patients with pulmonary sarcoidosis in the peer-reviewed medical journal CHEST. We presented a poster at the European Respiratory Society, or ERS, International Congress on findings for an antibody for immunohistochemical detection of Neuropilin 2, or NRP2, in patient tissue samples. NRP2 is efsofitamide's binding partner. And these findings suggest that this antibody may provide an extremely useful clinical tool, potentially aiding in patient selection or stratification. We received FDA Fast-Track designation for esophidamide for the treatment of systemic sclerosis, SSC, or scleroderma-associated ILD. We announced a research collaboration with Dual Systems Biotech AG, a company specializing in custom proteinomics to identify and validate 10 new target receptors for tRNA synthetases from our intellectual property, or IP, by 2025. This collaboration is a way to potentially accelerate drug discovery efforts and identify new drugs from our platform. And finally, we received a notice of allowance from the U.S. Patent and Trademark Office for antineuropillin-2 monoclonal antibodies which is the first to be granted to our IP estate for this program. We've experienced another quarter of crisp operational execution, both internally and in cooperation with our partners and collaborators, and we anticipate a strong finish to the year. Now let's focus on some more specific updates around our clinical program for Epsom Phenomot. As a reminder, Epsom Phenomot is a first-in-class immunomodulator for fibrotic lung disease. Epsilfitamide is a novel FC fusion protein based on the naturally occurring splice variant of the lung-enriched tRNA synthetase HARs fragment that downregulates aberrant immune responses in inflammatory disease states. Epsilfitamide has been shown preclinically to downregulate inflammatory cytokine and chemokine signaling and reduce inflammation and fibrosis. The NRP2 receptor is upregulated on key immune cells during active inflammation and is enriched in inflamed lung tissue. Efsofitamide 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. We're developing efsofitamide as a potential treatment for patients with ILD, a group of rare immune-mediated fibrotic lung disorders. Our initial ILD indication is pulmonary sarcoidosis. Sarcoidosis is the most prevalent ILD and is characterized by the formation of granulomas, which can occur in any organ, but predominantly affects the lungs. If left untreated, this can lead to irreversible scarring or fibrosis, which greatly increases the risk of death. We estimate that there are close to 200,000 patients with pulmonary sarcoidosis in the US, and around 150,000 in the major European markets, with another 20,000 in Japan. Up to 75% of patients require treatment for their disease, and approximately half of these will have progressive disease despite treatment. Around one in five of all patients will go on to develop lung fibrosis. First-line treatment is typically corticosteroids, which may effectively control symptoms, but are associated with severe debilitating side effects, particularly with chronic treatment. In patients unresponsive to steroid treatment, cytotoxic immunosuppressants or biologic immunomodulators may be used, but are also known to cause serious side effects. The use of all of these therapies is empiric and not supported by current clinical evidence standards. We believe the addressable market for efsofitamide in the three geographies mentioned is around 200,000 patients. Even with conservative assumptions, this represents a significant market opportunity in sarcoidosis alone. Efsofitamide has received orphan drug designation and fast track designation from the FDA for sarcoidosis. We see upside potential for efsofitamide in other forms of ILD. This includes indications such as scleroderma-related ILD, where we have also garnered FDA orphan drug and fast-track designation. Also other connective tissue disease-related ILDs, and chronic hypersensitivity pneumonitis, among others. These diseases share overlapping immune pathology with sarcoidosis, and others having limited treatment options, and efsofitamod has demonstrated efficacy in animal models of these diseases. Taken collectively, this represents a multi-billion dollar market opportunity for efsofitamod in ILD, and ATIRES poises a front runner in this expansive opportunity. Now let's recap the data we have generated for efsofitamod and some updates on the current efsofit study. In September 2021, we reported clinical proof of concept for efsofitamide based on positive results from a Phase 1b-2a study in pulmonary sarcoidosis. The study, which included a forced steroid taper, demonstrated safety, tolerability, and consistent dose response for efsofitamide on key efficacy endpoints and improvements compared to placebo, including measures of steroid reduction, lung function, sarcoidosis symptom measures, and inflammatory biomarkers. Just this past week, the full results from this study were published online in the peer-reviewed medical journal, Chest, with Dr. Daniel Culver, Chief of Pulmonary Medicine at the Cleveland Clinic, serving as lead author. This marks the first peer-reviewed publication of clinical data for efsofitamide, or for that matter, any tRNA-sensitase-derived therapy, in a major medical journal. These data indicate that efsofitamide is providing substantial benefit to patients, improving lung function and symptoms of cough, shortness of breath, and fatigue, all while reducing their toxic steroid burden. According to medical experts, this is the first randomized placebo-controlled trial of any therapy for pulmonary sarcoidosis that demonstrates effects on physiologic and quality of life measures concurrent with steroid reduction. With the full data set now available for review, we expect this publication will generate additional education, awareness, and support for efsofitamod among the specialist and generalist provider community, particularly as we are currently enrolling for efsofit. Efsofit is a global pivotal phase three randomized double-blind placebo-controlled study to evaluate the efficacy and safety of efsofitamod in patients with pulmonary sarcoidosis. It is a 52-week study consisting of three parallel cohorts randomized equally to either three milligrams per kilogram or five milligrams per kilogram of efsofitamide or placebo, dosed intravenously once a month for a total of 12 doses. The study intends to enroll 264 patients with pulmonary sarcoidosis at multiple centers in the US, Europe, and Japan. The trial design incorporates a forced steroid taper and the primary endpoint of the study is steroid reduction. Secondary endpoints include measures of lung function and sarcoidosis symptoms. We've dosed the first patient in the study and have several sites in the U.S. open for enrollment. We expect additional sites to open in the U.S. later this year. And we'll remind you that this is a global study. We held a productive meeting with European investigators during ERS in September, and we now have rapidly achieved regulatory approval to proceed with the study in a number of countries, including the UK, Netherlands, France, and Spain. We anticipate sites opening for enrollment in those countries in the coming months and early 2023. Finally, our partner, Cure and Pharmaceutical, has also completed submission of the Clinical Trial Notification, or CTN, in Japan, and we could see a center there open for enrollment by the end of the year. We're highly encouraged by the rapid pace of this progress, as it permits us to initiate the study in those regions and signifies alignment with these regulators on the trial design, including the steroid-sparing primary endpoint. I want to give kudos to our regulatory group, led by Dr. Bob Ashworth, for skillfully navigating towards these regulatory approvals. Epsilfit is expected to be the largest interventional study for patients with sarcoidosis to date. It is also the largest study that Atire has undertaken in the history of the company. We're laser focused on assuring that this study receives the resources it requires, and we intend to focus our resources on FSOFIT to ensure its completion. Shifting to our preclinical and discovery programs, let's discuss some of the progress with our pipeline. This includes ATYR 2810, and today we'd like to provide a strategic update regarding this program, which we have advanced to be phase one ready. Due to current market conditions and the need for prioritization of capital, most importantly focusing our resources on the FSOFIT study, we made the strategic decision not to use our internal resources to initiate a phase one study of 2810 this year. We intend to look at other potential non-dilutive avenues, including academic collaborations or other funding sources to bring this program forward. Multiple academic centers are particularly interested in advancing 2810 in rare aggressive cancers where many patients remain unresponsive to currently available treatments, such as neuroendocrine prostate and pancreatic neuroendocrine tumors. Recent published literature regarding the role of NRP2 in these types of cancers and interest from these centers have encouraged us to consider interrogating an anti-NRP2 agent, such as 2810, in these indications. This includes an exciting publication recently from one of our key collaborators, Dr. Kastubh Dada, and his colleagues from the University of Nebraska Medical Center, indicating the role of NRP2 in promoting metastasis and conferring therapeutic resistance in neuroendocrine-like prostate cancer, which outlines the potential for the therapy in this aggressive tumor type. As a reminder, 2810 is phase one ready, having completed IND enabling activities, including GMP manufacturing and GLP tox studies. And we have been granted allowance from the US Patent and Trademark Office for the patent for anti-NRP2 antibodies, which covers us for 2810. I'll close with reiterating how excited we are with our tRNA Synthetase platform and what it's yielded thus far as we get closer to our mission of translating our tRNA synthetase biology into new therapeutics for fibrosis, inflammation, and cancer. We've advanced efsofitamide, which is derived from a fragment of histidyl tRNA synthetase, or HARs, into now a Phase III study. Meanwhile, we've identified and validated the receptor target for a fragment of another tRNA synthetase, allonyl tRNA synthetase, or ARs, and we expect to reveal the receptor of yet a third fragment This one from aspartyl tRNA synthetase, or DARS, in the near future. I'll now turn it over to our Chief Financial Officer, Jill Broadfoot, to review our financial results.