Good morning, everyone and welcome to the NRx Pharmaceuticals’ Third Quarter Results and Conference Call. Currently, participants are in a listen-only mode. [Operator Instructions] As a reminder, this conference call is being recorded. I will now turn the call over to Eric Goldstein, Managing Director, LifeSci Advisors. Please go ahead, sir.

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 SEC. The forward-looking statements made during this call speak only as of 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 maybe 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 Chief Executive Officer 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 their prepared remarks, the management team will address investor questions. I will now turn the call over to Jonathan.

Thank you, Eric. 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 are making, advancing our pipeline of 3 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 will spend just a few moments summarizing the major developments in these areas over the quarter and in recent weeks. And then I will 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 will start with an update on our lead program, ZYESAMI or Aviptadil for the treatment of patients with acute respiratory failure in critical COVID-19 and potentially other respiratory conditions. When we began this project in March 2020, Aviptadil was never formulated as commercial growth for intravenous use and we discovered that none of the analytic methods or required manufacturing processes has been developed. When our partner’s upcoming ZYESAMI’s development in January 2021, we continued at full speed, and at this point have invested the majority of the R&D expenses associated with bringing this potentially lifesaving drug in dormant file to the patient’s bedside. Our financial statements speak for themselves. Our shareholders have supported us in continuing the progress. 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 4, the FDA declined to issue an Emergency Use Authorization for ZYESAMI for…

Although the planned trial is technically a non-inferiority trial, we believe it is possible that BriLife will demonstrate a better immune response to several variants of concern than the competitor vaccine. Indeed, we have already seen that early data from IIBR, demonstrating neutralizing antibody levels against the Delta variant in vaccinated patients that are as high that 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 the efficacy of BriLife against the original COVID virus and it’s 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 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 IIBR, has enabled a rapid tap through 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. And as the Delta and subsequent variants continued 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 with 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 shutdown, beds were converted to COVID beds. And we are now preparing…

Thank you, Jonathan. I will 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 U.S. 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 ZYESAMI. 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 ZYESAMI. 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.

Thank you, Randy. Before taking questions, I just want to emphasize our commitment to efficient growth 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 have 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 needs where we can have the most impact. We have realized that it’s a bit unusual 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 transaction from proving safe to 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 a review of our new ZYESAMI 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 are putting in place the infrastructure to support our transition to commercial operations to support both ZYESAMI and BriLife. And we are 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. Eric, we are ready to take questions.

Thank you. We have a question on the held Phase 2/3 trial. How many patients have been enrolled to-date? And when do you expect completion?

Well, as we have said, we are expecting completion in the first half of 2022 as the pandemic gains speed. And unfortunately, we are in the middle of an uptake – an uptick in cases, enrollment has become more rapid. So, we may be able to pull that completion date further forward.

Okay. Question on the BriLife vaccine, can you provide more detail and when you may seek regulatory approval or authorization from the health regulatory authority?

We are 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. The vaccine effectiveness was seen by health authorities and patients who were vaccinated. That is there are people walking around with green passports, who got the BriLife vaccine and were not required to be vaccinated with mRNA. We are going to be starting a non-inferiority registration trial comparing BriLife to a known vaccine. And depending on how quickly that trial enrolls, and what happens with the pandemic, really depending on whether we are 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 are talking about going all the way to new drug approval for a vaccine, then you would be expecting a more traditional year to 18 months time point. But if these variants continued to come out as the way they have, and if the vaccine lives up to some of the hopes, we could be looking at a shorter timeframe.

Thank you. Yes, we had a question asking about further detail breakthrough designation of our ZYESAMI, and the chances of breakthrough designation when you might get an answer from the FDA, any more updates on timing?

We are expecting FDA’s response to our breakthrough therapy designation towards the end of the month. And we have taken a step that we think is a bit unusual. We have posted the contents of our breakthrough therapy designation or tests 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 have submitted. And we look forward to the FDA’s response.

Okay. Thank you. We have a general question about COVID. What are your thoughts on COVID, will it continue to remain present and will get worse as we get further into the colder months?

Well, I think the most important thing, as we are now precisely 2 years from the original recognition of COVID outbreak in Wuhan, China. And we are about 20 years from humanity’s first known encounter with lethal coronavirus, the original SARS epidemic. And of course, it’s possible that coronavirus has attacked humans in the past. But we are so lethal that goes epidemic pouring 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 2 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 spent his life as a public health professional, I think that humanity is encountered 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 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 variance of the coronavirus. And we are 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 are talking about with ZYESAMI and with the BriLife vaccines are benefits that humanity is going to need. But at the same time, we hope that people will realize that Aviptadil, ZYESAMI is not just a coronavirus drug. This is a drug that protects the lining of the lung in a very profound way. It protects the alveolar type 2 cell, which makes the surfactants that the lungs depends upon in order to transmit oxygen from the lungs – from the air into the bloodstream. And that’s why we focused on the original intent of ZYESAMI which was for acute respiratory distress syndrome. And now that we finally have a manufactured form of ZYESAMI that can be mass produced and introduced into clinical trials, the opportunity to test ZYESAMI in a whole variety of lethal lung conditions. So, thank you for Eric.

That is all the questions we have. Thank you, everyone for joining us this morning. This concludes the NRx Pharmaceuticals third quarter results conference call. Thank you all for participating.