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spk05: Good morning, everyone, and welcome to the NRX Pharmaceuticals third quarter results and conference call. Currently, participants are in a listen-only mode. Later, we will conduct a question-and-answer session. As a reminder, this conference call is being recorded. I will now turn the call over to Eric Goldstein, Managing Director with LifeSci Advisors. Please go ahead, sir.
spk00: Thank you, Operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made in this call is contained in our periodic reports filed with the FDC. The forward-looking statements made during this call speak only as to the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements. Information presented on this call is contained in the press release issued yesterday after the market closed and in the company's Form 10-Q, which may be accessed from the Investors page of the NRX Pharma website. Joining me today on today's call from NRX Pharmaceuticals are Jonathan Javitt, Chairman and CEO of and Randy Guggenheimer, Chief Business Officer for NRX. Jonathan will provide a summary of the company's progress during the quarter and recent weeks before turning it over to Randy for a review of the company's financial results. Following our prepared remarks, the management team will address investor questions. I will now turn the call over to Jonathan. Thank you, Eric.
spk03: Good morning, everyone, and thank you for joining us today. We appreciate your attendance, and we look forward to answering your questions. This morning, we issued a press release outlining the progress we're making, advancing our pipeline of three late-stage programs with significant potential in COVID and other respiratory illnesses, COVID vaccination and bipolar suicidal depression, as well as in our preparations for transition to commercial operations. I'll spend just a few moments summarizing the major developments in these areas over the quarter and in recent weeks, and then I'll turn the call over to Randy for a review of our third quarter financial results. Then we'll be happy to answer the questions some of you have submitted. I'll start with an update on our lead program, Zysami, or Aviptadil, for the treatment of patients with acute respiratory failure and critical COVID-19 and potentially other respiratory conditions. When we began this project in March 2020, Abitidil was never formulated as a commercial drug for intravenous use, and we discovered that none of the analytic methods or required manufacturing processes had been developed. When our partner stopped funding Zysami's development in January 2021, we continued at full speed and at this point have invested the majority of the RMB expenses associated with bringing this potentially life-saving drug from dormant files to the patient's bedside. Our financial statements speak for themselves. Our shareholders have supported us in continuing the project, and 18 months from a cold start with dormant files, we have data that we believe will ultimately support our drug's full approval pending a second confirmatory trial and may support earlier avenues for rushing this drug to patients. As we announced on November 4th, the FDA declined to issue an emergency use authorization for Zysami for the treatment of critical COVID-19 with respiratory failure, a disappointing decision in our view, but one that does not alter our plans for or confidence in the potential of Zysami for treating COVID and numerous other diseases that damage the lining of the lungs. Now that President Biden has nominated an FDA commissioner, we look forward to providing the FDA with the additional data that they require to let us give patients one last chance to make it home to their loved ones. While we hope to secure an earlier path to treating critically ill COVID patients, we anticipate that the NIH active 3D trial will provide clear proof of Zysami's efficacy and safety. Active3B has now enrolled more than half of its targeted 660 patients, and Zysami has passed multiple safety and futility assessments by its independent data safety and monitoring committee. Dr. Fauci has briefed the White House and Congress about NIH's decision to test Zysami, an unproven medicine from a small and then private company, in a global phase three trial. On September 21st, Dr. Francis Collins, director of the NIH, gave a public presentation in which he identified Zysami as one of only a dozen candidates in hospital therapeutics in the NIH active program that have survived to phase three from a starting cohort of more than 600 candidate drugs. Intravenous Zysami may be unique in targeting patients who have run out of other options, and you can find a number of first-person accounts in the media of patients who have made it home to their families when all otherwise seemed lost. Today, with our partners in the NIH ACTA 3B program, we continue to engage with regulators and potential partners on multiple concepts to advance Zysami toward worldwide regulatory approval. NIH recently opened regulatory files for Zeisami with the European Medicines Agency, the United Kingdom Medicines Regulatory Agency, and the Brazilian Health Regulatory Agency. Now that we have FDA review of our manufacturing module and have passed a European qualified person or QP inspection, NIH plans to take the ACTIV-3B trial to Europe, the United Kingdom, and Brazil using our commercial-scale medicine. The use of commercial-scale product in the ACTIV-3B trial potentially supports new drug approval for Zysami without future additional bridging studies. The regulatory files opened by NIH on our behalf will help provide the foundation for worldwide development of Zysami both to treat COVID and also to treat a myriad of other lethal conditions that attack the lung. Because of our fast-track designation for Zysamin, the FDA agreed to allow rolling review of our new drug application. Therefore, elements such as CMC, manufacturing, and non-clinical safety and toxicology will be reviewed in advance of reviewing efficacy data. We continue to believe that the Zysami offers a chance at life to those with COVID-19 respiratory failure who have exhausted all currently approved therapies. While we await approval, Zysami remains available to patients upon a physician's request under federal and state right to try laws for those patients who meet the legal criteria. In their letter advising us of their EUA decisions, The FDA stated that the decision was in part based on their review of safety data from only 131 randomized patients treated with Zysami and asked us to present additional data. We were surprised that the FDA did not consider the 150 or more additional patients already treated with Zysami in the NIH ANCA3B trial with no serious adverse events, and we are continuing to coordinate that review and bring those patients into the review, as well as the review of more than 300 patients treated with Zysami under our expanded access programs. On November 2nd, the NIH Data Safety and Monitoring Board, or DSMB, concluded its third scheduled analysis and again found no new safety issues after reviewing a total of more than 300 patients. which is nearly half of the participants expected to participate in the trial. In August, we announced new findings from our Phase 2b3 IV trial, demonstrating clinically significant improvement on two intermediate endpoints, relief from respiratory distress and prevention of cytokine storm in critical COVID-19. Patients in this trial treated with Tysami demonstrated improvement in blood oxygen within a day of initiation of therapy, which is indicative of improved lung function. Patients treated with Zysami similarly showed far lower levels of cytokine IL-6 than those treated with placebo. People are well aware of the role of cytokine storm in the lethal effects of COVID-19. Both findings are highly and statistically significantly correlated with improved survival and recovery from COVID-19 in this clinical trial. This is our basis for applying for new drug approval under FDA's accelerated approval pathway. In October, we announced the publication of peer-reviewed results from a prospective open-label administratively controlled trial of Avistadil for the treatment of respiratory failure in patients with critical COVID-19. This study reported 60-day survival in 81% of those treated with Avistadil compared to 21% survival among those who received standard of care treatment at Houston Methodist Hospital. A similar nine-fold advantage was seen in the cumulative probability of recovery from respiratory failure. Now, it should be noted that these patients were too acutely ill and had morbidities that disqualified them from being enrolled in our randomized trial. These results were published in the Journal of Infectious Diseases and Treatment. In addition to these trials of IV dysamines, We also anticipate data from our ongoing trials of the inhaled formulation. The AVI-COVID-2 trial of inhaled Zysami versus placebo is sponsored by NRX, and we currently expect a first data monitoring committee review for the inpatient component of this trial by the end of this year. The FDA has asked us for more data in support of future regulatory filings. Large federally supported trials are under, are underway to generate those data, and we're committed to delivering those data and other information that may emerge to the FDA as quickly as we can. The FDA has expressed a commitment to working with us and to reviewing additional data as it's presented. Let me turn to where we are on commercial preparation of Zysamin, because we believe There will be an ongoing need for improved therapies to treat severe COVID for some time. And accordingly, we're moving forward with our commercial preparations for this trial. We've contracted with Cardinal Health for third party logistics and commercial services. We've also contracted with IQVIA for pharmacovigilance upon any potential approval or authorization. We're pleased to announce that during this quarter, Gysami has finally evolved from an early clinical stage medicine to a medicine that is ready for widespread use in clinical trials and ultimately commercialization and delivery to the patient's bedside. When we began this project in March 2020, Aviptadil had never been formulated as a commercial drug for intravenous use. and we discovered that none of the analytical methods or required manufacturing processes had been developed. Because of the public health emergency, the FDA took the unusual step of allowing us to formulate the original clinical trial medicine in an FDA-inspected 503B pharmacy in handmade batches of 300 doses per batch with a shelf life of only 62 days. And that means that we were actually making drugs every week, sometimes twice or three times a week, in order to keep up with the clinical trial demand. In September 2020, we initiated a manufacturing partnership with Nefron Pharmaceuticals of West Columbia, South Carolina. One year later, we and Nefron have developed, with the support of our investors, proprietary and validated methods for manufacturing at scale and for proving manufacturing quality, and stability. We are now able to release batches of up to 100,000 doses with a shelf life of 150 days, which we continue to work to extend. Thus, for the first time in its history, Aviptadil, now Zysamine, is a commercial-ready drug. When we initiated this project, neither we nor our partners possessed a single gram of Aviptadil ingredient, that is the drug substance, with which to begin development. Aviptadil had never been manufactured at commercial scale suitable for inclusion in the national stockpile. We were able to restart an old manufacturing process to get us into clinical trials. But even that process was capable of making only 100,000 doses of Avifidil every two months. And the manufacturing process itself is no longer feasible because of new EPA guidelines. With the assistance of the U.S. government, we partnered with the Polypeptide Group of Torrance, California, to design and implement a proprietary, modern, high-capacity manufacturing process for our Aviftadil drug ingredient, a process capable of delivering 5 million doses of GMP-grade drug substance per batch. We're about to receive our second manufacturing run of Aviftadil drug substance from this process. Although Aviftadil is a natural peptide that is vasoactive intestinal peptide and not protectable by patent, We've now built a body of proprietary processes, some of which we are likely to patent, that we believe will afford us valuable and protectable intellectual property over and above the data exclusivity that we expect to obtain from the FDA and other regulators. Other natural peptides, such as insulin and human growth hormone, have benefited from similar forms of intellectual property protection. In October, we submitted a revised investigational new drug module on the manufacturing of Zysami, which confirms that Nefron is prepared to supply Zysami on a commercial scale and includes all of our manufacturing methods and analytic methods. This module will be incorporated in the FDA's rolling review process, supporting the NDA for Zysami. We've received multiple inquiries from investors and the public about introducing Zysami to Europe and the UK, where the public health emergency continues to claim lives on a daily basis. Unfortunately, until last month, there was simply no Zysami in existence that was manufactured to EU or UK standards for introduction into those territories. The handmade clinical trial supplies were adequate for ongoing trials and to meet right-to-try requests in the United States. Without Sysami manufactured to UK standards, neither we nor any partner was legally in a position to submit for or obtain emergency use in Europe or the United Kingdom. A regulatory application requires both evidence of safety and efficacy and evidence that medicine has been manufactured and will be supplied in a manner that meets local GMP or good manufacturing practice regulations. Clinical data that supports safety and efficacy alone is not sufficient. Our application to the FDA for emergency use authorization was supported by the manufacturing data from NEFRON. NIH requested a waiver from EU authorities to accept Sysami manufactured to the GMP standards that are accepted in the U.S. and implemented in our FDA-inspected facility. However, this request was not granted. Zysami is a sterile liquid product intended for intravenous injection and therefore subject to a particularly high level of manufacturing rigor. The technical difference between U.S. and EU requirements in this case is that the EU requires plant operators to change their protective clothing twice and pass through a second airlock as they enter the sterile core of the plant. Although we demonstrated a perfect record on sterility in our FDA-inspected facility, and despite the requested waiver from the second airlock requirements on our behalf, the EU authorities required full compliance with their more stringent manufacturing regulations. To make Zysami available to residents of Europe and the UK during Q3, we established a separate manufacturing capability that meets EU standards in conjunction with Alchemy Incorporated. Last month, a European qualified person or QP auditor completed an inspection at the Alchemy manufacturing facility with no adverse findings. A QP auditor is responsible for certifying that each batch for medicinal products meets all required provisions when released from a manufacturing facility within the EU or imported into the EU. And the declaration is required by the EU regulatory authorities for the release of Zysami and its introduction into the EU. Now that we've met the EU and UK sterile products manufacturing requirements, the NIH is deploying Zysami in Europe, the United Kingdom, and Brazil as part of the ANCO3B trial. We anticipate that the EU, UK, and Brazil phases of active 3B, led by NIH, will support the efficacy and safety of Zysami for people who live in these territories and will ultimately support our application for drug approval in these territories. Meeting the EU and UK manufacturing standards and passing the QP audit now enables us to immediately apply to EU, UK, and Brazilian regulators for emergency use of Zysami while Active3B completes its enrollment. We've retained expert regulatory counsel in the EU for that purpose. To the best of our knowledge, we're the only company with a manufactured stable formulation of intravenous and inhaled Avistol inspected to international standards. Without manufactured drug, there was no regulatory filing to be made. Now there is, and we've moved forward to register our drug worldwide in the face of a rapidly resurgent pandemic that is claiming more lives every day. To do otherwise would be unconscionable. At the same time, we remain committed to mediating our collaboration agreement with Relief Therapeutics in a manner that respects the risks taken and contributions made by the shareholders of both companies in bringing this lifesaving drug to patients. As we previously announced, the Nation of Georgia Ministry of Health granted us emergency use authorization based on examination of our data by Georgia's National Society of Physicians. We continue to anticipate first revenues by year end pending the formation of Georgia's new government. We're in active conversation with several other health authorities in the Caucasus region and neighboring countries and look forward to updating shareholders in the future. We're continuing to invest in Zysami to bring this medicine to patients. In 2022, we plan to launch a clinical trial of Zysami to treat acute respiratory distress syndrome caused by sepsis, which was the original dream of Professor Sami Saeed and his research team. In the future, we aim to launch trials of Zyxami to treat sarcoidosis, checkpoint inhibitor pneumonitis, acute smoke inhalation, and a variety of other lethal pulmonary conditions. Aviptadil has also been used off-label by more than 10,000 Americans for the treatment of allergy-related conditions, according to FDA testimony. and we anticipate learning more about the role that Zysami might play in this setting. We're working with several partners, both to design digital health solutions that will make our medicine more convenient and impactful for patients, and new dosage forms that will make our medicine both more convenient for patients and longer-lived, especially at room temperature. During the quarter, we advanced the engineering of our digital health solution for inhaled Sysami in partnership with Pill Tracker Limited. This enterprise was originally funded by the Israel Innovation Authority, the Byrd Foundation of the U.S. State Department, Merck KAG Ventures, and private investors to track compliance with and medical results of medicines used in clinical trials. Although Pill Tracker was originally envisioned around solid dose medicines, i.e. pills and capsules, Pill Tracker's technology was selected by the boards of NRX and Relief Therapeutics at the time we filed our inhaled use IND with FDA because we mutually recognized the need for a technology that would track adherence to our inhaled form of Zysami and simultaneously measure the clinical benefits, such as improved blood oxygen, and ambulatory capacity. We anticipate that PillTractor's technology will be deployed in our inhaled use trial by year end. Although we're encouraged by the progress we have made in formulating Zysami for intravenous use, we continue to believe that patients will ultimately need a convenient means of administration that is stable at room temperature. Accordingly, in August, we partnered with Mankind Corporation to explore the use of Mankind's Technosphere delivery system, the system that supports their inhaled insulin products, as a means of enabling patients to carry and use Zysami in a compact, simple device. Now, that Mankind device also contains a Bluetooth chip that is designed to be able to integrate with digital health solutions such as pill trackers. We're also exploring the option of using thin-film freezing, a proprietary system developed by TFF Pharmaceuticals, as a means of achieving a long-term stable version of Zysami suitable for stockpiling. Let's turn to BrieLife. In July, we added a third phase three program to our company when we signed a memorandum of understanding with Israel's Institute for Biological Research, or IIBR, to complete development and commercialization of their innovative, experimental, and possibly revolutionary COVID vaccine, known as Brilife. In this collaboration, the IIBR provides technical assistance and will receive customary royalty and milestone payments for its intellectual property in exchange for worldwide exclusive rights on the part of NRX to develop and market the Relife vaccine. As a self-propagating live virus vaccine, Relife differs from other COVID vaccines as it presents the entire spike protein of the SARS-CoV-2 virus to the body's immune system rather than merely a small segment of that spike protein. Moreover, the vaccine itself continues to evolve and develop its own variants of the COVID spike protein. We like to think of Freelife as a sheep in wolf's clothing. In other words, it's a benign virus, but it looks to the body as if it was a coronavirus and generates that immune response. We believe this may be the reason that the Freelife vaccine shows encouraging protection against Delta and other variants of concerns in preclinical studies. And just this week, information was released suggesting that that same protection against Delta has been seen in early human studies with the Brie Life vaccine. Additionally, as new variants are discovered, the spike protein complex of those new variants may be rapidly added to the Brie Life vaccine thereby expanding the spectrum of coverage and adaptability to future variants. In October, we concluded a business mission to Luxembourg at the invitation of the Luxembourg Ministry of the Economy for the establishment of vaccine manufacturing capability for Brilife to serve European and adjacent markets. We've been granted an operating company business license by the Luxembourg government and established a commercial banking relationship with BNP Paribas Luxembourg. We're currently negotiating a comprehensive banking and supply chain finance solution in preparation for tech transfer, scale-up, and manufacturer of real life. And we are working to put in place the manufacturing backbone that will enable us to begin building a large-scale capability to deliver commercial quantities of the vaccine. We've signed an agreement with Exocera, a highly respected CDMO close to Luxembourg, to begin technology transfer and scale up with Relife. The vaccine is manufactured by a newly developed bioreactor technology, previously developed for gene therapy. We're fortunate that Luxembourg has shown us a confluence of unique technologic capability and enthusiastic financing environments and a set of government priorities that include the type of environmentally friendly, high technology, high tech manufacturing we require to advance real life to the next level. We hope to initiate GFP vaccine manufacture in the first half of 2022 and to have results to share with you by the time of our first quarter 2022 conference call. In August, we announced the initiation of a phase 2B trial of free life vaccine to be conducted in the nation of Georgia. Georgia is a particularly promising location for clinical development because of the Senator Richard Lugar Center for Public Health Research built by the U.S. government and operated by leading scientists in Georgia. Those plans to conduct a placebo control study were interrupted by its media reports that BreLive had unexpectedly demonstrated early signs of efficacy, particularly against the Delta variant, and that patients vaccinated with BreLive were given green passports as if they were vaccinated with an mRNA vaccine. Based on this surprising and encouraging news, we and our CRO partners consulted with the World Health Organization and the European Medicines European Medicines Agency, and decided to move directly to a Phase 2b3 registration trial. This study will compare Brie Life's ability to generate an immune response compared to an already licensed vaccine. The Phase 2b3 trial will be conducted in multiple nations, supported by national governments and their health ministries, together with our CRO partner, PROMOS LLC. Although the planned trial is technically a non-inferiority trial, we believe it is possible that 3Life will demonstrate a better immune response to several variants of concern than the comparator vaccine. Indeed, we've already seen that early data from IIDR demonstrating neutralizing antibody levels against the Delta variant in vaccinated patients that are as high, that is, are as potent as the neutralizing antibody levels seen in those same patients against the original wild-type coronavirus. We aim to enroll sufficient patients to prove efficacy of relife against the original COVID virus and its variants of concern by mid-2022. We believe that the emergence of the COVID Delta variant during this past summer and the rapidity with which this and other variants have eroded the immunity generated by first-generation vaccines, highlight the unmet need for a COVID vaccine that provides long-lasting and safe immunity that is resistant to new variants of the virus as they emerge. The significant research investments already made by the IIVR has enabled a rapid path to registration studies. We at NRX are honored to have been selected for this project and grateful for the trust placed in us by the government of Israel, the people of Georgia, and its neighboring countries. As the Delta and subsequent variants continue to threaten the immunity generated by first-generation vaccines, we hope that this new vector-based approach may offer enhanced immunity. So finally, let me turn to where we are in our ongoing development of NRX 101. As you know, NRX 101 was our foundation program for the treatment of suicidal bipolar depression. The clinical trial was interrupted by the surge, the initial surge of the coronavirus pandemic when multiple psychiatric facilities were shut down, beds were converted to COVID beds, and we are now preparing to restart our phase three trial and currently expect enrollment to resume in early 2022. Suicidal depression is a condition that accounts for approximately 50,000 deaths annually in the U.S., according to the U.S. Centers for Disease Control. Suicidal bipolar depression represents a unique unmet medical need, especially since the only currently approved treatment for people who have this condition is electroshock therapy. We've been awarded breakthrough therapy designation by the FDA for NRX-101 in this indication. NRX-101 is a patented fixed-dose combination of d-cycloserine and lorazodone, which has a dual targeted mechanism of action designed to achieve a clinically meaningful level of NMDA blockade without the side effects associated with other well-known NMDA antagonists such as ketamine. Five human studies have shown a positive effect on depression and or suicidal ideation associated with D-cycloserine. There's a compelling unmet need for an orally available, non-addictive, non-neurotoxic NMDA-targeted drug to treat depression that doesn't cause hallucinations and is tolerable and safe for patients. The development of NRX101 is based on Dr. Daniel Javits' early discovery of the role of the brain's NMDA receptor in psychiatric disease and his lifetime of research in neurochemistry that led to the award of a composition of matter patent in 2020. The composition of matter patent awarded for this dual-targeted mechanism of NRX101 is extensible to other dual-targeted drugs. for major depression and other conditions. We have a special protocol agreement in place with the FDA for NRX101 pivotal trial, and NRX101 has been granted breakthrough therapy designation, fast track designation, and has received a biomarker letter of support from the FDA. We believe that if our phase three pivotal trial results replicate those observed in our phase two study, we will meet FDA criteria for approval and we'll have a clear path for NDA submission to the FDA in 2022. With that, I'll turn it over to Randy for an overview of our financial results.
spk01: Thank you, Jonathan. I'll begin with the $30 million private placement we completed in August, in which we sold approximately 2.7 million shares of common stock and preferred investment options. With this transaction, our cash position was $38.9 million as of September 30, 2021, compared to $1.9 million as of December 31, 2020. We believe we have sufficient cash to support operations through the next 12 months. Note that our clinical trial operations for ACTIV-3B and I-SPY are primarily funded by the US government. Net loss for our third quarter was $20.8 million compared with a net loss of $5.2 million for the three months ended September 30, 2020. This was primarily due to non-cash expenses associated with the establishment of key partnerships and an increase in clinical trials and development expenses related to Zysami. Reimbursements from relief therapeutics were zero for the third quarter of 2021 compared to $2.9 million for the third quarter of 2020. Research and development expenses for the third quarter were $6.3 million compared to $4.3 million for the prior year period. The increase was primarily driven by an increase in clinical trials and development expenses related to Zysami. General and administrative expenses for the quarter were $13.8 million, of which $9.3 million were non-cash stock-based compensation and consulting fees. For the prior year quarter, G&A expenses were $3.8 million, of which $2.8 million was non-cash stock-based compensation, consulting fees, and warrant expense. The increase was primarily due to the increase in the non-cash stock-based expenses, as well as an increase in insurance expenses. Other expenses for the three months ended September 30, 2021 were $0.7 million, compared to zero for the three months ended September 30, 2020. The increase was primarily due to increases in earn-out cash liability and warrant liability. With that, I will turn it back to Jonathan for closing remarks.
spk03: Thank you, Randy. Before taking questions, I just want to emphasize our commitment to efficient drug development and ask you to focus on our belief that not only do we need to focus on clinical safety and efficacy, but on the manufacturability of our lead programs. We've made tremendous progress in our three lead programs in an incredibly short period of time and have efficiently utilized our resources and energies in areas of critical need where we can have the most impact. We realize that it's a bit unusual for small-cut biotechnology companies to focus on manufacturability of new medicines to the extent that we have. However, we believe that early focus on CMC, that is chemical manufacturing controls, analytics, and manufacturing is critical if there is to be a smooth transition from proving safety and efficacy to being able to ship a new medicine or vaccine to patients immediately upon approval. We look forward to working with FDA and regulators around the world on an ongoing basis for review of our new ISAMI data as it becomes available. Moving forward with our accelerated new drug application, and we look forward to FDA's response to our application for breakthrough therapy designation by the end of the year. And currently, we're putting in place the infrastructure to support our transition to commercial operations to support both Zysami and BreLife, and we're planning to resume enrollment in our NRX 101 Phase 3 trial. In 2022, we can look ahead to multiple data readouts and other catalysts and remain confident in the opportunities before us. We appreciate the continued trust that you, our shareholders, have placed in us. and we reaffirm our commitment to bringing life-saving treatments to patients with lethal conditions that are not addressed by current therapies.
spk02: Eric, we're ready to take questions. Thank you.
spk00: We have a question on the HAL Phase 2-3 trial. How many patients have been enrolled to date, and when do you expect completion?
spk03: Well, as we've said, we're expecting completion in the first half of 2022 as the pandemic gains speed. And unfortunately, we are in the middle of an uptake, an uptake in cases. Enrollment has become more rapid. So, we may be able to pull that completion date further forward.
spk02: Okay.
spk00: Question on the Brie Life vaccine. Can you provide more detail on when you may seek regulatory approval or authorization from the Health Regulatory Authority?
spk03: We're expecting to see Phase 2 placebo-controlled results coming out of Israel by the end of this year. And that's based on the reports that have already surfaced in the press that efficacy was seen, that vaccine effectiveness was seen by health authorities in patients who were vaccinated. That is, there are people walking around with green passports who got the real life vaccine and were not required to be vaccinated with mRNA. We're going to be starting a non-inferiority registration trial comparing real life to a known vaccine. And depending on how quickly that trial enrolls and what happens with the pandemic, really depending on whether we're able to see the same kind of effect against the Delta and other variants of concern in this next trial. that's already been seen in the patients vaccinated in Israel, we could be talking about applying for some form of regulatory approval towards the midpoint of 2022. Of course, if we're talking about going all the way to new drug approval for a vaccine, then you'd be expecting a more traditional year to 18 month time point. But if these variants continue to come at us the way they have and if the vaccine lives up to some of the hopes, we could be looking at a shorter time frame.
spk02: Thank you.
spk00: We also have a question asking about further detail, breakthrough designation of Zysami and the chances of breakthrough designation, when you might get an answer from the FDA. Any more updates on timing?
spk03: We're expecting FDA's response to our breakthrough therapy designation towards the end of the month. And we've taken a step that we think is a bit unusual. We've posted the content of our breakthrough therapy designation request on our website so that shareholders and members of the public can understand exactly why we believe this is a breakthrough drug and why we believe it demonstrates preliminary evidence of efficacy, which is the regulatory requirement for breakthrough therapy designation. So people are free to read what we've submitted, and we look forward to the FDA's response.
spk02: Okay, thank you.
spk00: We have a general question about COVID. What are your thoughts on COVID? Will it continue to remain present, and will it get worse as we get further into the colder months?
spk03: Well, I think the most important thing, because we're now precisely two years from the original recognition of COVID's outbreak in Wuhan, China. And we're about 20 years from humanity's first known encounter with lethal coronaviruses, the original SARS epidemic. And of course, it's possible that coronaviruses attacked humans in the past, but were so lethal that those epidemics burned themselves out. And certainly the same thing happened with SARS. It was such a lethal virus. that the SARS epidemic was pretty much contained simply because the people who were exposed to that virus died and the spread was contained. But here we are two years into this pandemic where the coronavirus has learned how to live in people, to not kill too many of them, you should pardon the expression, and therefore, to be able to spread from person to person in a pandemic way. And as somebody who's spent his life as a public health professional, I think that humanity's encounter with the coronavirus is going to be a long-lived one the same way that humanity's encounter with influenza viruses is here to stay. So this pandemic has a ways to go. We don't yet have drugs that can stop, although we do have drugs that are at least showing promises for reducing the virulence of the coronavirus. And we're seeing the virus' ability to present itself in new variants and new mutations that are able to circumvent some of the original vaccines. So Unfortunately for humanity, probably the benefits that we're talking about with Zysami and with the Brie Life vaccine are benefits that humanity is going to need. But, you know, at the same time, we hope that people will realize that Aviptadil, Zysami, is not just a coronavirus drug. This is a drug that protects the lining of the lungs. in a very profound way. It protects the alveolar type 2 cell, which makes the surfactants that the lung depends upon in order to transmit oxygen from the lung, from the air into the bloodstream. And that's why we've focused on the original intent of Zysami, which was for acute respiratory distress syndrome. And now that we finally have a manufactured form of Zysami, that can be mass-produced and then produced into clinical trials, the opportunity to test CySAMI in a whole variety of lethal lung conditions.
spk02: So, thank you, Eric. That is all the questions we have.
spk00: Thank you, everyone, for joining us this morning. This concludes the NRX Pharmaceuticals Third Quarter Results Conference Call. Thank you all for participating.
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