Scinai Immunotherapeutics Ltd. (SCNI) Earnings Call Transcript & Summary

Good afternoon. My name is Joshua Phillipson, and I'm a member of BiondVax's management team. It's a pleasure to be here today at Vaccines 2020 Virtual Conference. First, I must note that since we're a publicly traded company, I get to share these exciting words with you. It’s a very exciting and busy time at BiondVax these days as we await results of a pivotal clinical efficacy Phase III trial of our M-001 Universal Influenza Vaccine candidate. The M-001 is based on research originally conducted at the Weizmann Institute of Technology in Israel by our Chief Scientific Officer, Dr. Tamar Ben-Yedidia and Professor Ruth Arnon, who is also known as the co-inventor of the multiple sclerosis drug, COPAXONE. Our Universal Flu Vaccine candidate aims to address a vast unmet need. Each year, worldwide, there are up to an estimated 4 million severe flu illnesses and 650,000 deaths. The CDC reports up to 900,000 flu-related hospitalizations and up to 80,000 deaths each year in the U.S. alone. Most seasonal flu morbidity and mortality occurs in older adults. In addition to seasonal flu, there is the constant threat of pandemic flu. COVID-19 clearly highlights the extreme challenges a pandemic brings, and there is currently a general consensus that the next influenza pandemic is not a question of if, but rather when. Historically, flu pandemics have occurred about 4x per century. The most recent was 2009's H1N1 swine flu pandemic. And just over 100 years ago, the great Spanish flu pandemic caused an estimated 50 million to 100 million deaths worldwide. In addition to mortality, as we are unfortunately witnessing today, pandemics can overwhelm health care systems and devastate families, businesses and economies. The reality of seasonal flu and the threat of pandemic flu clearly highlight the need for a proactive prophylactic vaccine that can effectively reduce the burden of influenza and help flatten the curve of severe illness. Unfortunately, current flu vaccine solutions fall short. Seasonal flu vaccine effectiveness is only about 40% on average overall and significantly less in the at-risk 65-plus adult population. In contrast, vaccines for other infectious illnesses, such as measles, rubella, diphtheria, tetanus, et cetera, achieved much higher vaccine effectiveness into the '90s, approaching 99% effective. One of the reasons that current flu vaccines are poorly effective is that the flu virus mutates frequently and unpredictably, resulting in new flu strains. To date, over 40,000 strains have been identified, and current flu vaccines target only 3 or 4 existing strains. Furthermore, most marketed flu vaccines rely on an old manufacturing process in eggs that takes 4 to 6 months to complete. So each year in late winter, experts through the WHO select the 3 or 4 strains to be included in the following winter seasonal flu vaccine in the hope that the selected vaccine strains will sufficiently match the following season's circulating strains. Often, a vaccine virus mismatch occurs. That is the vaccine strains do not adequately match the circulating strains. This mismatch is a significant factor contributing to the low effectiveness of current flu vaccines. To summarize, there is not only a vast unmet need for improved flu vaccines, but also a need for a complete paradigm shift in influenza vaccination. And this is where BiondVax's M-001 comes in. M-001 is a single recombinant protein consisting of 9 highly conserved influenza epitopes. It is designed to serve as a common denominator to influenza. M-001 does not change year-to-year or season-to-season, and therefore, can be manufactured and administered year round. Its constant structure is intended to provide a significant base of protection against seasonal influenza A and B strains as well as rapidly emerging avian and swine flu pandemic strains. Just to drive this point home, today, should a new pandemic flu strain emerge, it could take months to bring a strain-specific vaccine to the population. Conversely, since M-001 is designed to serve as a common denominator also to new emerging strains, it can be stockpiled in advance and administered immediately upon any new flu pandemic. Furthermore, M-001 is manufactured using advanced and scalable manufacturing technologies, including fermentation in E. coli. And this, together with its constant structure, allows year-round production, distribution and vaccination at scale. To date, we have constructed a pilot manufacturing facility at our headquarters in Jerusalem with planned annual capacity of 10 million to 20 million doses in bulk. M-001's mechanism of action is intentionally different from that of current seasonal flu vaccines. M-001 works initially by triggering cell-mediated or innate immunity. And through this also enhances the adaptive or B-cell immunity. Since most of a virus' life cycle occurs within the host cell and out of the reach of antibodies, it is believed that inducing a strong cellular response will significantly contribute to M-001's effectiveness. Eight clinical trials have been successfully completed in a total of 818 adults ranging from 18 to over 90 years of age. Results indicate that M-001 is safe and well tolerated with a safety profile comparable to that of current non-adjuvant seasonal flu vaccines. To date, no treatment-related serious adverse events have been noted, including in the nearly complete Phase III trial. Results also indicate that M-001 induces cell-mediated immune responses to a broad range of flu strains. Most recently, the Phase II trial in the U.S.A. conducted by the NIAID of the NIH concluded, this is the graph in the bottom-right corner, the trial concluded that M-001 was found to be safe and that it "induced significant polyfunctional T cell responses". Results also indicate that M-001 may enhance humoral HAI responses to current flu vaccines. Note, for example, on the top left, the BVX-005 trial conducted in adults aged 65-plus that a higher HAI response was noted in trial participants who received M-001 and then later, the regular strain specific flu vaccine as compared to participants who received the regular flu vaccine only. Another exciting outcome of that BVX-005 trial that took place in 2011 was discovered and published a few years later following the 2014/'15 flu season, during which a new flu strain, a Swiss, emerged. We tested participant serum from BVX-005, which had been stored since the end of that trial, and found that 4 years later, compared to the placebo group, 5x more seniors who received M-001 were zero protected from this new strain. Now the evidence that M-001 is safe, well tolerated and immunogenic to a broad range of flu strains is certainly encouraging, and it led us to conduct the current pivotal clinical efficacy Phase III trial. This trial is testing the clinical effectiveness of M-001 alone by itself. The placebo-controlled trial is being conducted in over 12,400 older adults, all over age 50, with half of 65 plus, over 2 flu seasons, 7 countries and 83 sites. The breadth of time and geography increases the likelihood that the trial population will be exposed to multiple circulating flu strains. The trial's primary endpoints are safety and reduction in flu illness rate. Secondary endpoints include reduction in severity as measured by reduction in hospitalizations or reduction in duration of illness. The primary cause, of course, of this year's COVID surge on hospitals. In light of the current pandemic, achieving the secondary endpoints is potentially at least as important as reduction in illness rate. The Phase III trial began prior to the 2018/'19 flu season, and the last participant's final visit occurred last month. We currently anticipate announcing top line results by the end of this October. From Ruth Arnon's idea in the early 1990s, it's been a long, steady road, and we are naturally excited to learn soon to what extent BiondVax's M-001 can serve to reduce the burden and threat of both seasonal and pandemic influenza. If you'd like to follow our story, you're welcome to visit biondvax.com and follow us on Facebook, Twitter and LinkedIn. Thank you. I wish us all good health.